CA2212650C - Apparatus and method for vein removal - Google Patents
Apparatus and method for vein removal Download PDFInfo
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- CA2212650C CA2212650C CA002212650A CA2212650A CA2212650C CA 2212650 C CA2212650 C CA 2212650C CA 002212650 A CA002212650 A CA 002212650A CA 2212650 A CA2212650 A CA 2212650A CA 2212650 C CA2212650 C CA 2212650C
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- body portion
- tissue structure
- lumen
- advancement
- dissection
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- UMRZSTCPUPJPOJ-UHFFFAOYSA-N C(C1)C2CC1CC2 Chemical compound C(C1)C2CC1CC2 UMRZSTCPUPJPOJ-UHFFFAOYSA-N 0.000 description 1
- GDOPTJXRTPNYNR-UHFFFAOYSA-N CC1CCCC1 Chemical compound CC1CCCC1 GDOPTJXRTPNYNR-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00008—Vein tendon strippers
Abstract
This invention is a device (10) and method for removing a generally cylindrical tissue structure such as a blood vessel from the body of a human or animal. The device (10) includes a body portion (14) having distal and proximal ends with at least one lumen (24) extending longitudinally through the body portion (14). The lumen (24) is sized to accommo date the vessel and at least one tool used in removing the vessel.
Description
APPARATUS AND METHOD FOR VEIN Rl :MOVAL
FIELD OF THE INVENTION
This invention relates to ~pa~alus and methods used to harvest a 5 generally cylindrical shaped tissue structure from the body of a patient. Moreparticularly, the invention is directed to an a~alalus and method for harvestinga section of a blood vessel from a patient.
BACKGROUND OF THE INVENTION
In certain circllm~t~nces it is desirable to remove sections of tubular tissue structure from a patient's body. Such tissue may be used in another part of the patient's body, may be transplanted into a second patient's body or may be discarded. As used herein, the term "tubular tissue structure" includes bloodvessels, tendons, bile ducts and any other similar tissue formation which is 15 generally tubular in structure and capable of being separated from ~ o~lding tissue. Although the invention herein will be discussed in terms of harvesting blood vessels it should be understood that the appa~alus and method described are equally applicable to harvesting other tubular tissue structure.
Vein harvesting is commonly done in connection with coronary artery 20 bypass surgery. The s~rh~nous vein is a subcutaneous vein which is often usedfor coronary artery bypass grafting, infra-in~lin~l bypass grafting and vein-vein bypass grafting. Other veins may also be used including the m~mm~ry vessel and the lessor saphenous vein. Previously, it has been necess~ry to make an incision along the full length of the vein section to be removed. The vein is 25 then freed by severing and lig~ting the branches of the vein, after which thesection of the vein can be removed from the p?~tiP.nt The full leng~ incision must then be closed, for example by s~ ring or ~t~rling Obviously, the harvesting of the vein in this m~nn~r leaves ~ fi~lrin~ scars which are cosmetically undesirable. Additionally, the large incision creates a risk of CA 022126~0 1997-11-19 WO 97/21398 PCI'/US96120M5 infection to the patient and may not heal properly, especially with those patient's who have poor circulation in their e~ ~ilies. Such an incision may create a chronic wound which will not heal.
Devices for harvesting a section of a blood vessel without creating a full length incision have been s~lggeste~ U.S. patent number 4,793,346 to Mindich discloses a device for harvesting a section of a blood vessel by m~king only small incisions at opposite ends of the blood vessel section. The device includes a guide rod which fit's inside of the vein section and a tube having anirmer diameter slightly larger than the outer diameter of the vein section to beharvested. The tube has one or more knife blades at the lea~in~ edge which are connected to an electrical supply. The vein section is removed by m~king the incision sufficiently deep so as to expose the ends of the blood vessel to be harvested. The blood vessel is cut to expose one end, the guide rod is inserted inside the blood vessel section, and the tube is placed over the end of the blood vessel section to be removed. The tube is then pushed along the blood vessel (into the patient) while rotating the tube to sever the branches of the blood vessel with the knife blade mounted at the le~1ing edge of the tube. Electrical ~iu,l~nl is supplied to the knife blades to heat the blades and thereby cauleli~e the ends of the severed branches of the blood vessel. The procedure is contimle-1 until the tube has reached the second of the two incisions. The bloodvessel is exposed and cut from the patient at the second incision. The tube is then removed from the patient with the blood vessel section inside of the tube.
The blood vessel section is then removed from the tube for further l,e~
and use as desired.
UK patent application GB 20 82 459A discloses a device for harvesting a section of a blood vessel similar to that disclosed in the ~in~lich patent.
Again, two incisions are made, one at each end of the blood vessel section to beharvested. A guide rod is inserted into the blood vessel section through one of the incisions and a tube having a cutting elçment having a cutting tool at it's WO 97/21398 PCr/US96/20775 opc.~Live end is passed over the blood vessel section and guide rod assembly.
The tube is rotated as it passes over the blood vessel section to sever the connecting br~n~lles. After the tube has passed the entire length of the blood vessel section, the section is cut away ~rough the second incision and the tube 5 is removed from the patient with the harvested section inside the tube.
Blood vessel harvesting devices of this type have certain distinct disadv~nt~ges. While they elimin~te the need for a full length incision to remove the blood vessel se~ nt two incisions, one at each end of the segment to be harvested, are required in order to remove the blood vessel se~n~nt For 10 patient's likely to develop chronic wounds, each additional incision increases the risk to the p~ti~.nt and it is desirable to keep such incisions as close to the patient's trunk as possible and to minimi~e the number and size of such incisions. A~lition~lly~ such devices are unable to adequately close off severalbranches of the blood vessel and thus are unable to adequately control bleeding.15 As a result, the patient suffers greater blood loss than is necessary. These prior devices may also remove more tissue than is n~cec.c~ry because the size of the cutting device is not readily adaptable to the ch~nges in the size of the blood vessel.
In U.S. patent number 5,373,840 to Knighton an l~lov~d device and 20 method for vein removal is disclosed which solves some of the problems associated with the use of prior art devices. KnightQn discloses an endoscope having a lumen e~t~n~ling lon~ in~lly through the scope body. The endoscope includes means for viewing an area ~ cent the distal end of the lumen. The lumen has a lateral (limen~ion large enough to accommodate the 25 blood vessel being harvested and at least one tool for use in harvesting the blood vessel. A first end of the blood vessel section to be harvested is exposedthrough an incision in the patient's body. A ~ secting tool and a gripping tool are inserted through the lumen of the endoscope and used to dissect the blood - vessel away from the ~ uul~ding connec~ve tissue of the patient's body.
Additional tools are provided for use through the lumen of the endoscope to remove body fluids and co~ te bleeding tissue, to ligate and sever side branches from the blood vessel to be harvested, and to ligate and sever a distalend of the blood vessel to be harvested when a desired length of blood vessel 5 has been dissected. Only a small incision in the patient's body is necessary to harvest a relatively long length of blood vessel in a precise and controlled m~nner using this device and procedure.
Although the '840 patent to Knighton conctih1tes a significant improvement in devices and techniques for vein harvesting, it's multiple tools 10 require more than one operator to complete the procedure. Additionally, it's single lumen design requires that the vein be contained within the same lumen as the various tools which are used duIing the ~ seclion procedure. This makes it possible for the vessel to be d~m~ge~ during the dissection process by the tools which share the same lumen. It is critical that the se~ment of blood 15 vessel being harvested is handled with great care since it is destined for reuse (as in arterial bypass). Therefore, it is desirable to isolate the vessel as much as possible from the tools which are used in the dissection.
There is a need for a device and method for vein removal which allows a vein to be harvested in an efficient and safe m~nner from the body of the 20 patient. Specifically, it would be desirable to provide a device which can beeffectively opelalt;d by a single o~alor/~lysician while at the same time protecting the segTnent of the vessel being removed from the tools which are used in the procedure.
SIJMMARY OF THE lNVENTION
In accordance with the present invention there is disclosed a device for removing a generally cylindrical tissue structure from a patient's body. The tissue structure may be a blood vessel, bile duct, tendon or other similar cylindricaVtubular tissue structure which may be removed and/or reused in ~e WO 97nl398 PCT/US96/20775 patient's body or another patient's body. The device includes an elongated body portion having distal and ploxilllal ends and at least one lumen e~tçn~ling k~ngi~l-lin~lly ther~lh~ough. The lumen is sized to accommodate the tissue structure and at least one tool used in removing the tissue structure. Means is S provided for isolating the tissue structure from the tools used in removing the tissue structure in order to protect the tissue structure from (l~m~ge The device may include viewing means to enable the operator to remotely view an area adjacent the distal end of the body portion.
The lumen of the body portion may comprise separate vessel and working lllm~.n~, the vessel lumen being sized to accommodate the vessel or similar tubular or cylindrical tissue structure and the working lumen or lllmP.n~
being sized to accommodate the tools used in the removal procedure. The separation of the vessel lumen and working lumens protects the vessel from the tools used in the procedure. ~ltPrn~tively~ the lumen may comprise a single lumen which inclndes a section which accommodates the vessel and a working section which accommodates the tools.
The vein harvesting device inc]ndes means for ~iet~k~ble connection to the vessel. The connection means may comprise an ~lligPtor clip like structure which is connected at its proxi.llal end to a tension means which ~ .c tension on the connection means and hence the vessel in the direction of the ~,lo~llal end of the body portion when the connection means is connected to the vessel. A housing is provided through which a body portion may be advanced or retracted through ~e body portion by the operator controlling an advanc~ .nt means.
The device may include one or more tools sized so that it may be accommodated within the lumen. The tool has a distal o~e,~live tip which may be used to cut a side branch of the vessel, cut the vessel, apply a ligation clip to a side branch of the vessel, apply a ligation clip to the vessel, or remove a patient's body fluids.
WO 97/21398 PCr/US96/20775 The device inch1des means for (li~secting the vessel from ~ oullding tissue. The dissection means may comprise a generally cylindrical structure having a length at least as great as the lumen e~n~ling through the body portion. The cylindrical shape defines a lumen which is sized to accommodate 5 the vessel which is drawn into the lumen of the ~ii.csection means as the vessel is dissected from ~ulluunding tissue. The tli~section means is sized to be accommodated within the vessel lumen. The device inchllles means fûr advancing or retracting the (li~section means through the lumen.
The invention also incllldes a method of removing a section of generally 10 cylindrical tissue stlucture such as a blood vessel from a patient's body. The method inch1des providing a device having an elongated body portion having distal and pluxilllal ends and at least one lumen ext~.n-ling lonpit~l~in~lly thcre~.rough. The lumen is sized to accommodate the tubular tissue structure and at least one tool used in removing the tissue structure.
A first end of the tubular tissue structure section to be harvested is exposed through an inci~ion in the patient's body. A gripping tool is inserted through the lumen and the first end of the tissue structure is gripped with the tool. The su~ ullding tissue is dissected away from the tubular tissue structurewith a (ii~sec1ing element. During the procedure the body portion and the 20 ~ sectinp~ c}ell-elll are advanced along the tubular tissue structure until adesired length of tissue structure is reached such that the ~li.csecte~l portion of the tissue structure 5;~ 5 into the lumen. During the ~ section process the tubular tissue structure is isolated from the tools used in removing the tissue structure except at the distal end of the body portion where the dissection 25 procedure is pel~lllled. When the desired length of the tissue structure is reached, the tissue structure is cut at its distal end with a transecting tool which may be inserted through the lumen. ~lt~.rn~tively, a second incision can be made through which the distal end of the tissue structure may be cut.
Where the tissue structure being harvested is a blood vessel, the method may further inclu~e advancing the body portion and a dissecting element along the vessel until a side branch of the vessel in encoulllered. A ligation member is then applied to the branch and the branch is cut between the vessel and the ligation member with a lig~ting-cutting tool inserted through the lumen. The method may also inclllde controlling bleeding as necess~ry with a bleeding control tool inserted through the second lumen. In one embo-liment the method inchl(les providing a viewing ~lement to enable viewing of the vein dissection in progress. In a fur~er embodiment the method incllldes m~ g tension on the gripping tool in the direction of the ~lo~ lal end of the body portion such that tension on the vessel is ~-~ e~ during (lissection.
BRIEF DESCRIPTION OF THE DRAWINGS
The folegoil,g and other aspects of the present invention will be best ~pleciated with reference of the detailed description of the invention which follows when read in conjunction with the acco"l~ jing drawings wherein:
FIG. la is a perspective view of the vein removal device of the present invention, FIG. lb is a fr~nented top view of the removable ~,loxilllal end of the device, and FIG. lc is a rear view of a portion of the device.
FIGS. 2a and 2b are top views of FIG. la illus~ ing ~e increm~nt~l advanc~ment of the dissecting element and the advancement of the body portion of the device, respectively.
FIGS. 3a, 3b and 3c are partially exploded views of the actuator handle, top view of ~e slctl~tor lever, and front view of the actuator lever, respectively.
FIG. 4 is a cross-sectional view of a first embodiment of the multi-lumen body portion of the device taken along line 4-4 of FIG. 1.
FIG. 5 is a cross-sectional view similar to FIG. 5 of a second embodiment of the body portion of the device of FIG. 1.
FIGS. 6a and 6b are sectional views taken along line 6-6 of FIG. la.
wo 97nl398 PCT/US96/20775 FIGS. 7a arld 7b are partial sectional views taken along line 7-7 of FIG. 6a.
FIG. 8 is a schem~tic view of the vein harvesting device of the present invention being used in the removal of the saphenous vein of a patient.
FIG. 9a is a side sectional view of a ligation-cutting tool of the present invention, with it's distal end shown enlarged in perspective, FIG. 9b is a top plan view of the distal end of the ligation-cutting tool of FIG. 9a, and FIG. 9c is a side elevational view of the distal end of the ligation-cutting tool of FIG. 9a.
FIG. 10 is a side elevational view of a side-biting ligation-cutting tool of 10 the present invention, with it's distal end enlarged in perspective.
FIG. 11 is a side elevational view of a suction-co~ tor tool of the present invention.
FIGS. 12 and 13 are enlarged perspective illustrations showing the distal end of the vein h~ ~sling tool in use during the harvesting of a blood vessel.
FIGS. 14, 15 and 16 are enlarged perspective illustrations showing the distal end of the vein harvesting device and the tools of FIGS. 9-11 in use during the harvesting of a blood vessel.
While the above-idçntified drawing figures set forth one ~lcf~lled embodiment of the invention, other embo-limPnt~ are also c~nlelllplated, as 20 noted in the discussion. In all cases, this disclosure ~lesenl~ the present invention by way of represent~tion and not by limit~tion. It should be understood that numerous other modifications and embo~liment~ can be devised by those skilled in the art which fall within the scope and spirit of the principle of this invention. It should be speçific~lly noted that the figures have not been 25 drawn to scale as it has been necess~ly to enlarge certain portions for clarity.
In other figures fragment~ry views are shown which omit certain structure for the purpose of more clearly illustrating the invention.
WO.97/21398 PCT/US96nO775 DETAILED DESCRIPTION OF THE INVENTION
The Vein H~u ve~ g Device The structure of the vein h~veslillg device of the present invention can be understood generally with reference to FIGS. 1-8. The tools which are used 5 in connection with the device dDg the vein harvesting procedure are shown in FIGS. 9-11 while FIGS. 12-16 illustrate the device and it's associated tools being used in a vein ~ v~ling procedure.
The present invention is a device and method for harvesting a section of cylindrical andtor tubular tissue structure such as a vessel from a patient's body.
10 The invention also has application for removing such tissue from animal bodies. The section may be used in another part of a patient's body or for transplanting into a second patient's body. For example, a section of the s~rh~nt~us vein may be removed for use in coronary bypass surgery. The blood vessel needs to be removed without undue ~l~m~ge to the blood vessel, as well 15 as with ~ A1 d;~..~e and trauma to the p~ient Although the description herein is directed to the h~v~sli-~g ofthe s~rhen()us vein, it is conlel~lated that the present invention could be used in connection with the efficient and effective harvesting of other vessels, tubular tissue structures or other generally cylindrical structures such as tendons from a patient's body. Structures will 20 generally be compn~e~ of human tissue although the device and methods disclosed herein would work equally well for harvesting synthetic tissue and structures.
FIG. la is a perspective view of the vein harvesting device 10 in accordance with the present invention. Device 10 includes a housing 12 25 through which an elongated body portion 14 is advanced during a vein harvesting procedure. Housing 12 and body portion 14 may be constructed of a rigid material such as metal or plastic. A remote actuation handle 16 is connected to housing 12 by a flexible biaxial cable 18. Actuation handle 16 is used to selectively advance either body portion 14 or vein dissection element w o s7nl3ss PCT/US96nO775 20 in a m~nner which will be more fully described with respect to FIGS. 2 and 3. Vein ~lissection el~ment retraction knob 22 protrudes from housing 12 and allows vein dissection elemçnt 20 to be retracted during the procedure.
As best seen in FIG. 4 which is a sectional view taken along 4-4 in FIG.
la, body portion 14 includes vessel lumen 24, viewing lumen 26, irrigation lumen 28 and working lumen 30. Each of the l unens runs longih--lin~lly through body portion 14 from an opening at the distal end to an exit port at or near the p~ al end of the body portion as seen in FIG. lc. Working lumen 30 has its exit port 31 at the ~ro2~ lal end of body portion 14. ~rigation lumen28 has an exit port 29 (FIG. la) which may be connected to a source 46 of irrig~nt (FIG. 8). The function of each lumen will be described in more detail he~ el. Body portion 14 is of sllfficiPnt size and shape to accommodate the lumens.
Lumen 24 is of a size large enough to accommodate the blood vessel which is to be harvested and dissection element 20. During the harvesting procedure after an incision has been made and the vein is ligated and clipped, a~- vein attachment clip 32 is clipped to the vessel. Vein attachment clip 32 is connecte~l via cable 34 to a spring nl~c.h~ni~m 36 which m~int~in.~ a positive tension on the vessel in the direction of the plo~ al end of the vessel lumen during the (liccection procedure. This ~limin~tes the need to use a separate gripping forceps to hold the vessel during the procedure as in U.S. patent number 5,373,840. Vessel lumen 24 may be provided with an irrig~tinn port 25 which may be connected to a source of irri~nt (not shown) to allow irrigation of the vessel being harvested, as desired.
Vessel lumen 24 is subst~nti~lly circular and has a diameter and length which may be varied depen~lin~ upon the length of the vein section to be harvested and/or the size of the patient from which the vein is to be removed.
Typically, the length of body portion 14 will be in the range of 30 to 60cm and the rli~met~r of the vessel lumen 24 will be in the range of 5-7mm.
WO 97nl398 PCT/US96/20775 Endoscope lumen 26 is sized to accommodate a fiber optics viewing device 38 which inchl-les an a~ opliate fiber optics illllmin-q-tion source.
Device 38 is positioned such that the area imme~ qtely adjacent the distal end of body portion 14 can be illnminqte~l and viewed by the operator. As seen in 5 FIG. 8, device 38 is operably connected to an externql monitor 40 which includes a suitable light source by conduit 42. Conduit 42 enters the endoscope lumen at en(loscope port 44 (FIG. la). Irrigation ch~q-nnel 28 is operable coupled to the ext~.rnql source of irrigqnt 46 via a suitable conduit 48.
Vein ~lissection element 20 is used to aid in s~p~alillg the vessel being 10 harvested from the sul,.,ullding tissue. Dissection element 20 has a generally rigid cylindrical body which may be comprised of met, l or rigid plastic. The diameter of the cylin~ric-ql body of dissection element 20 is sized to accommodate the vessel being harvested. The distal end of the tli~section elemlo.nt has a rounded or beveled distal edge 50 used to separate the blood 15 vessel from the ~w~oullding connec.*ve *ssue as the dissecting element 20 is advanced over the blood vessel. Dicsecting element 20 is provided in a - plurality of sizes for Lrrerclll si~s of blood vessels. Typical sizes would have inside diameters of 4mm, Smm, and 6mm. The cylindrical shape of dissec*on element 20 protc.;l~ the dissected portion of the vessel which is located within20 the dissection element. This feature is especially important in those embo-liment~ of the inven*on where the vessel lumen is not separate from the working lumen (i.e. FIG. Sb).
As an ~ltern~*ve to the cylindrical construction of ~i~section elemçnt 20, the structure may take the form of an elong~te~l shaft having attached at it's 25 pro~al end an ~nmll~r dissecting ring. This construction would be similar to the dissecting tool disclosed in U.S. patent number S,373,840 discussed above.
A dissection elçm~nt so cons~ucted may be inserted through vessel lumen 24 or, in the ~ltçrn~tive, may be inserted through a separate working lumen.
Utilizing a separate lumen allows the vessel to be completely isolated while in wo s7nl3ss PCT/US96nO775 the vessel lumen from the shaft of the dissection element and from all tools used in the procedure.
As seen in FIG. 4, working lumen 30 is generally arcuate in shape and positioned generally around the periphery of vessel lumen 24. Working lumen 5 30 is sized to accommodate the various tools used in the vein harvesting procedure which will be discussed in more detail with respect to FIGS. 9-11.
Typically, lumen 30 will be sized such that ~limPneion X in FIG. 4 is in the range of 5-lOmm. The shape of lumen 30 advantageously allows the tools to be used in various locations around each side and the underside of the vein.
10 Advantageously, the sep~l~ working lumen allows the tools used in the procedure to be completely separated from the ~li.esecte~l portion of the vessel in the vessel lumen thus redllcing the possibility of d~m~ein~ the vessel with the tools.
FIGS. 5a and 5b are views similar to FIG. 4 of ~ltçrn~tive configurations 15 for body portion 14. Tnete~ of a single arcuate working lumen 30 the body portion is provided with mllltiple working hlmP.ne 30A and 30B in FIG. 5a. In - FIG. 5b the working vessel lumens are combillcd into a single lumen having wo.killg sections 30C and 30D and vessel section 24A..
Body portion 14 of FIG. 5a is similar to that of FIG. 4 in that the vessel 20 lumen 24 is se~ te from the working lumen 30A and 30B. The embo-liment of FIG. Sa allows the tools used in harvesting the vein to be inserted on eitherside of the vessel lumen 24. The size and shape of working lllmPn~ 30A and 30B is selected to accommodate the tools used in the procedure. In the embodiment of FIG. 5a the lumens 30A and 30B are generally circular in cross-25 section and have a (1i~mr.t~r in the range of about 5-lOmm.
The embodiment of body portion 14 of FIG. 5b has a single combined working and vessel lumen with working sections 30C and 30D and vessel section 24A. Section 30C and 30D are of a size and shape to accommodate the tools used in the procedure. The vessel is protected from the tools by dissection element 20. Additionally, the vessel may be protected by sh~ring (i.e. as by ~ owillg) the junctions between the working sections and the vessel section such that the tools may not subst~nti~lly enter the vessel section. Other means of protecting the vessel may be employed such as by inl~ le 5 paItitioning the working sections from the vessel section.
Vein alt~rhment clip 32 is used to hold and retain the vessel being harvested during the procedure. Vein ~tt~çhm~nt clip 32 includes first and second opposed jaws 52 and 54, respectively. The jaws are tensioned towards the closed position similar to an ~llig~tQr clip which allows the jaws to obtain a 10 firm grip on the vessel. ~lt~m~tively, a l~tching mech~ni~m may be provided which locks the jaws in a set position. Spring mech~ni~m 36 m~int~in~ a positive ten~ion on vein ~tt~rhm~nt clip 32 through cable 34 towards the lal end of lumen 24 thus m~ tension on the vessel during the course of the ~ section procedure. Spring meçh~ni~m 36 is located within a 15 removable con~ lel 37 which is connecte~ to the plo~ al end of vessel lumen 24 by a bayonet lock mecl-~ni~... 39. Cont~iner 37 may be removed to allow - access to the dissected vein by pushing housing 37 towards the distal end of body portion 14 while twisting the housing 90~ clockwise.
As best seen in FIGS. 3a, 3b and 3c remote actuation handle 16 is a 20 scissors-type actuator and includes a lever 56. Lever 56 is positioned so that it may be moved to the right or left by the thumb of the operator. Lever 56 is used to engage one of two cables, 58 and 60, one of which is connected through biaxial cable 18 to a body portion advancement mech~ni~m 62 and the other of which is connected to a dissection element advancement meçh~ni~m 64 25 (FIGS. 6a and 6b). For example, the operator may choose to advance body portion 14 by moving lever 56 to the left. Lever 56 includes notches 66A and 66B which acco,~ odate cables 58 and 60, respectively. When lever 56 is moved to the left as shown in FIG. 3c cable 58 fits within notch 66A. A stop 68 is provided at the end of cable 58 which is larger than notch 66A so ~at WO 97/21398 PCI'/US96/20775 when the ope~lor squeezes the handles of the scissors-type actuating handle together cable 58 is retracted from biaxial cable 18. Similarly, a stopped 70 isprovided on cable 60 so that when lever 56 is moved to the right cable 60 may be retracted by sqvee7~in~ scissors-type actuation handle 16. Thus, by moving 5 lever 56 to the left or the right the opelalor can select whether to advance body portion 14 or ~iiccection elPment 20.
The details of the body portion advancem~nt meçh~nicm 62 and dissection element mech~nicm 64 are shown in FIGS. 6a, 6b, 7a and 7b. FIGS.
6a and 6b are cross-sectional views of the interior of the housing 12. Body 10 portion advancement mech~nism 62 incl~ ec ratchet wheel 72 fixedly connected to a spoked wheel 74 which rotates about an axle 73. Axle 73 is fixedly mounted to housing 12 in a m~m~Pr not shown in FIGS. 6a and 6b in order to simplify the Figures for purposes of clarity. Wheel 74 has spaced along its cir~ f~ence a plurality of generally circular pegs 76. Similarly, 15 dissection element advancement mech~nicm 64 includes a toothed ratchet wheel 78 fixedly connected to a spoked wheel 80 having a plurality of pegs 82 - spaced along its ci~cu~lrelellce. In a m~nner which will be described in more detail with respect to FIGS. 7a and 7b, retraction by the operator of cable 58 a~h~tçs body portion advancement meçh~ni~m 62 G~llsing body portion 14 to 20 advance in the distal direction through housing 12 while retraction of cable 60 causes ~licsection elem~nt advancemP-nt me~ ni~m 64 to advance dissection element 20 through lumen 24.
FIGS. 7a and 7b are fr~..F ~ cross-sectional views of dissection element advancPment mechA~ ... 64 showing cable 60 in the e~tPntle~l position 25 (FIG. 7a) and in the retracted position (FIG. 7b). Spokes 82 along the ci~ lrelellce of spoked wheel 80 extend through a slot 86 in body portion 14 (FIGS. 4 and 5) and align with mating openings 84 on the surface of dissection elçmP.nt 20. Therefore, rotation of spoked wheel 80 causes either advancement or retraction of ~iicseclion element 20 depending upon direction of rotation.
wo. s7nl3ss PCT/US96nO775 Rotation of spoked wheel 80 may be n~ ed by retraction of cable 60 by the oy~atol manipulating remote ~c~l~tQr 16 in the apyropliate m~nner. If lever 56 is moved to the right to engage cable 60 act~l~tion of the scissors-type actuator handle 16 will cause a retraction of cable 60. Cable 60 exten-lc 5 through biaxial cable 18 into housing 12 through a fixed member 86 which is either a portion of the housing or fixed thereto. Fixed member 86 has a plug 88 which acts as a stop for a spring 90. Cable 60 extendc through plug 88 and spring 90 and is fixedly connected to a movable cylinder 92 ratchet arm 94 is movably cormected to one side of cylinder 92. A Ratchet arm 94 pivots about a 10 point 96 and is positioned such that its ll~lllUW distal tip 97 mates with teeth 98 on toothed ratchet wheel 78.
When cable 60 is in the e~ten~led position as shown in FIG. 7a the distal tip 97 of ratchet arm 94 eng~s one of the teeth 98A on toothed wheel 78.
When cable 60 is retracted by the ~ytlalor~ cable 60 moves tow~ds the lS operator in the m~nner shown in FIG. 7b. Retraction of cable 60 in the direction of arrow 500 causes cylinder 92 to move in the direction of arrow 502. Ratchet arm 94 which is en~gecl by tooth 98A and causes both toothed wheel 78 and spoked wheel 80 to rotate in the direction of arrow 504. One squeeze of remote ~ct~tor handle 16 causes spoked wheel 80 to rotate an 20 amount cc"resyonding to the (1iepnce between teeth on toothed wheel 78.
Preferably, each squeeze of the ~c~ tion handle will cause the dicsection element to advance 5mm. This is a significant feature of the present invention since * allows the o~t,~tor to precisely and accurately control the advancement of the ~licsection element (or the body portion) in discreet increm~nt~l steps.
25 When the remote ~ch~tor handle 16 is rele~ced cylinder 92 returns to it's original position (shown in dotted line in FIG. 7b) due to the force exerted by spring 90. Pivot arm 96 is constructed so that it is fixed with respect to rotation towards the left side of FIG. 7b but will rotate towards the right side of FIG.
7b. Thus, when cylinder 92 moves to the position it occupied in FIG. 7a as WO 97~1398 PCT~US96/20775 shown in dotted line in FIG. 7b, pivot arm 96 will ride over the surface of the next tooth 98B. It thus returns to the position of FIG. 7a and is ready for the next increm~nt~l adv~ncement of dissection elem~.nt 20.
Body portion 14 is advanced in a m~nner similar to that of tliesectinn 5 element 20. The only LLrelence being that pegs 76 of spoked wheel 74 are aligned to engage with mating openings 99 in body portion 14. Lever 56 is moved to the right so that activation of scissors-type handle 16 will cause incrçmçnt~l advancement of body portion 14.
As best seen in FIGS. 6a and 6b retraction knob 22 iS provided to enable 10 ~ section element 20 to be retracted by the opel~lol during the vein harvesting procedure. In the prefelled embodiment vein ~issection element 20 iS advanced in 5mm increments to a length of about 5cm past the distal end of the body portion as shown in FIG. 2a. Once the dissection elem~ont 20 has been extlo.n~led a desired distance beyond the dishl end of body portion 14, body 15 portion 14 is advanced as shown in FIG. 2b. As seen in FIGS. 6a and 6b a suit,able clutch 87 is provided to pl~,.,nl ~ section elem~nt 20 from being - advanced when a side branch is encuun~ d. Clutch 87 may be of conventional const~uction and function to cause toothed ratchet wheel 78 to slipwith respect to spoked wheel 80 if the resistance in the advancement of 20 dissect,ion elem~nt 20 exceeds a pre-lel~ ...;. ,ed level which may cause d~m~ge to the side branch. When a side branch is encou,lL~ed or when the desired length of vessel has been obtained llis~ection element 20 may be retracted.
Retraction of dissection element 20 iS accomplished as shown in FIG. 6b by depressing retraction knob 22 in the direction of housing 12. Knob 22 iS
25 connected to shaft 81 which e~tPn~ls through a shtionary guide 83. Knob 22 and shaft 81 are biased in the position shown in FIG. 6a by a spring 85. When knob 22 is depressed as in ~e direction of arrow 508 in FIG. 6b shaft 81 causes toothed ratchet wheel 78 to become disen~e~l from pivot arm 96. Thus rohtion of knob 22 in a cou~llelclockwise direction as shown by arrow 510 CA 022126~0 1997-11-19 causes spoked wheel 80 to rotate in a direction opposite to that shown by arrow 505 in FIG. 7b. This correspondingly causes tli~section elem~nt 20 to move in a direction opposite arrow 506 thus resnlting in retraction of dissection element 20.
S
The Tools As shown in FIG. 8 when device 10 is used to harvest a blood vessel such as a saphenous vein 100, the device is used in conjunction with several tools. These tools are inserted into the working lumen 30 (FIG. 4), 30A, 30B
10 (FIG. 5a), or sections 30C, 30D (FIG. 5b) of body portion 14 at an entrance port (i.e. port 31, FIG. lc) located at the ~io~ lal end of the lumen. T_is allows the tools to be isolated from the vein during the dissection procedure tofurther protect the vein from any ~m~ge from tools being inserted, retracted or ~l~ipulated during the course of the procedure. A ligation-cutting tool 200 15 (FIG. 9) is used when severing side branches 102 from the blood vessel 100. Aside-biting ligation-cutting tool 250 (FIG. 10) is used to transect the blood vessel 100 when the dissection is completed. Finally, a suction-co~g~ tor tool 300 (FIG. 11) is used to control bleeding during the procedure.
The ligation-cutting tool 200 (FIG. 9a, 9b and 9c) is used to sever and 20 seal side branches on the vessel being harvested. The ligation-cutting tool 200 has an elon~te~ shaft 201, with a lig~tiQn clip applicator 202 and a cutting mech~ni~m 204 at the distal end of the sha~ 201. The ligation clip applicator 202 includes a first yoke 208 and a second opposed yoke 210. Each yoke 208 and 210 is in tum divided into two sections. Each yoke 208 and 210 is forked 25 at it's distal end, forming two opposed prongs 212A and 212B on the yokes 208and 210, respectively. The prongs 212A and 212B on the yokes 208 and 210 are parallel to each other and generally aligned with the longitll~lin~l axis of the ligation-cutting tool 200. The yokes 208 and 210 and the prongs 212A and 212B thereon oppose each other and serve to apply ligation clips 216 (see WO 97/213g8 PCT/US96/20775 FIGS. 9b and 9c) to a side branch 102 being severed. The opposing prongs 212A and 212B of each yoke 208 and 210 contain two grooves 214 respectively, to securely hold a ligation clip 216 therein. When the ligation clips 216 are thus held between the opposing prongs 212A and 212B of yokes 5 208 and 210, the generally U-shaped ligation clips 216 aid the operator in properly ~ligninp; the ligation-cutting tool 200 and the side branch 102 to be ligated by providing an al)u~ el-l for the side branch 102 when side branch 102 is positioned between yokes 208 and 210. When the yokes 208 and 210 are biased towards each other in a conventional m~nner, the ligation clips 216 are 10 deformed to clamp onto the side branch 102 there between and the blood flow through the side branch 102 is halted at two slightly spaced apart points (e.g.,two clips are applied ~l;~ox;...~tely 0.25 inches apart). When the ligation clipapplicator 202 is activated and the yokes 208 and 210 clamp the ligation clips 216 onto the side branch 102, the side branch 102 is held securely for cutting 15 the side branch 102.
The cutting mec~ni~m 204 on the ligation-cu~ting tool 200 includes a cutting blade 230 aligned between the prongs 212A and 212B and l~loxLIllal to the ligation clips 216. The cut~ng blade 230 is norm~lly retracted (as seen in FIGS. 9a, 9b and 9c) to allow the side branch 102 to be positioned properly 20 between the yokes 208 and 210. A cutting edge 232 of the blade 230 faces the distal end of the ligation-cut~ng tool 200 and the cutting motion of the blade 230 is in a distal direction (e.g., towards the side branch 102). The blade 230 is wide enough to completely sever the side branch 102 between the two yokes 208 and 210. The cuthng mech~ni~m 204 is activated by the opelalor (as 25 described below) after the side branch 102 has been ligated (i.e., the side branch 102 has been clipped shut and blood flow halted) and while the side branch is still held securely in the yokes 208 and 210. After the blade 230 has severed the side branch 102, the blade 230 returns into it's ori~in~ retracted position.
The ligation clip applicator 202 and the cutting mech~ni~m 204 are both achl~te~l by n ~çll~ni~m.c by the proximal end of the shaft 201 of the ligation-cutting tool 200. The ligation clip applic~tor 202 is preferably actuated by a scissors-type handle 220. By sqllee7.ing the scissors-type handle 220, the 5 opelalor causes each set of prongs 212A and 212B on the yokes 208 and 210 to be moved together, thereby CO~ SSi,lg their respective ligahon clip 216 about the side branch 102 of the blood vessel 100 as described above. The scissors-type handle 220 includes a l~tçhing mech~ni~m 222 which serves to secure the handle 220 and thus the ligation clip applicator 202 in a closed or 10 clamped position. While the ligation clip applicator 202 is held in a clampedposition, the cutting mech~ni~m 204 is ~ct l~te~ preferably by a plunger 204 located at the proximal end of the lig~tion-cutting tool 200. The plunger 224 isoperably conn~cted to the cutting blade 230 and biased pro~ ally to urge the blade 230 into it's normally retracted position. By moving the phlngçr 224 15 distally, the ope~lor causes the cutting blade 230 to likewise move distally and cut the side branch 102 of the blood vessel 100 which is ret~ine~l between the - yokes 208 and 210. When the o~ tor releases the plunger 224, the plunger 224 (and thus the cutting blade 230) retracts to it's original position.
Manipulation of the handle 220 then se~aldl~s the prongs 212A and 212B, 20 leaving the clip in place on the severed portions of the side branch 102 and the lig~tion cutting tool 200 is removed or relocated for reuse (the clips may be fed into place in the grooves of the prongs from a suitable clip m~g~7.ine not shown) to enable multiple lig~tion~ without removing the tool from the body.
The shaft 201 of the lig~ting-cut~ng tool 200 is a slender member that is 25 longer than the working lumen (30 in FIG. 4, 30A, 30B in FIG. Sa, 30C, 30D inFIG. Sb). A housing 209 covers those mech~nicm.~ on the shaft 201 that ll~ulslllil the l..~i~)ulations of the handle 220 and the plunger 224 at the ~oxill~al end of the ligation-cutting tool 200 to the clipping and cutting motions, respectively, at the distal end of ligation-cutting tool 200.
CA 022126~0 1997-11-19 WO g7/21398 PCT/US961~0775 The side biting-ligation-cutting tool 250 (FIG. 10) is used to sever and seal the distal end of the vessel being harvested. The side-biting ligation-cutting tool 250 is identical in operation to the ligation tool 200, except that the operative components at the distal end of the tool 250 are oriented generally 5 normally to the axis of the tool 250. As seen in FIG. 10, the side-biting ligation-cutting tool has an elong~te~l shaft 251, with a ligation clip applicator 252 and a cutting mech~ni~m 254 at the distal end of shaft 251. The ligation clip applir~tor 252 incl~l~es a first yoke 258 and a second, opposed yoke, 260.
Each yoke in turn is forked at it's distal end, forming two opposed prongs 262A
10 and 262B, respectively. The prongs are aligned generally parallel and each has two grooves 264 to retain ligation clips between each opposed pair of prongs 262A and 262B. The structure and operation of the ligation clip applicator 252 is similar to that illu~llaled in FIGS. 9b and 9c for the ligation-cutting tool 200.
The yokes 258 and 260 and the prongs 262A and 262B thereon oppose 15 each other and serve to apply lig~-on clips not shown in FIG. 10 to the distal end of the se~nent of the blood vessel being severed. When the ligation clips are thus held between the opposing prongs 262A and 262B of yokes 258 and 260, the generally U-shaped lig~tion clips aid in positioning and properly ~li~ing the side-biting ligation-cutting tool 250 and the blood vessel to be 20 transected by providing an abutment for the blood vessel when the blood vessel is positioned in the yokes 258 and 260. When the yokes 258 and 260 are moved towards each other, the ligation clips are clamped onto the blood vessel there between and the blood flow through the blood vessel is halted at two slightly spaced-apaIt points (e.g., two clips are applied ~plox;~ tçly 0.25 25 inches apart). When the ligation clip applicator 252 is activated and the yokes 258 and 260 clamp the ligation clips onto the blood vessel, the blood vessel is also held securely for cutting the blood vessel.
T_e cut~g mech~ni~m 254 on the side-biting ligation-cutting tool 250 includes a cutting blade 280 aligned between the prongs 262A and 262B.
Again, the structure of the cutting meçh~ni~m for the tool 250 is ~quite similar to that illustrated in FIGS. 9b and 9c for the ligation-cut~ng tool 200. The blade 5 280 is positioned such that a cutting edge 282 of the blade 280 does not intP.rfere with the ~ nm~nt of the blood vessel between the yokes 258 and 260.
The cutting blade 280 is normally retracted (as seen in FIG. 10) to allow the blood vessel to be positioned properly between yoke 258 and 260. The cutting edge 282 of the blade 280 faces in a transverse direction from the shaft 251 of 10 the side-biting li~tion-cut~ing tool 250, and the cutting motion of the blade 280 is in a transverse direction (e.g., toward the blood vessel). The blade 280 is wide enough to completely sever the blood vessel between the two yokes 258 and 260. The cutting meçh~ni~m 254 is activated after the blood vessel has been ligated (the blood vessel has been clipped shut and the blood flow halted) 15 and while the blood vessel is still held securely in the yokes 258 and 260.
After the blade 280 has severed the blood vessel, the blade 280 returns to its '~ original retracted position.
The p~ diL~rence between the tool 200 and tool 250 is that the distal operative portion of the tool 250 is oriente~ at an angle generally 90 20 degrees opposed to the axis of the shaft 251 of the tool 250. The yokes 258 and 260 are thus ori~nted to straddle a blood vessel ~rten-1ing generally parallel to the shaft 251 to apply li~;~tion clips thereto. After clips are applied, the yokes contimle to hold the blood vessel to permit severing of the vessel using the blade 280. O~her than the revision in orientation of the distal portion of the 25 ligation-cutting tool 250, it operates in the same m~nner as the ligation-cutting tool 200.
The ligation clip applicator 252 and the cutting meGh~ni~m 254 are both actuated by mech~nism~ at ~e proximal end of the shaft 251 of the ligation-cut~ng tool 250. The li~tion clip applicator 252 is preferably actuated by a scissors-type handle 270. Sqnee7ing of the scissors-type handle 270 causes each pair of prongs 262A and 262B on the yokes 258 and 260 to move together, thereby compressing their respective ligation clips about the blood vessel. The scissors-type handle 270 includes a l~tching meçh~ni~m 272 which 5 serves to secure the handle 270 and thus the ligation clip applicator 252 in aclosed or clamped position. While the ligation clip applicator is held in a clamped position, the lig~tinn cutting meçh~ni~m 254 is actuated, preferably by a pllmger 274 located at the ~o~ al end of the ligation-cutting tool 250. The plunger 274 is operably connected to the cutting blade 280, and biased 10 ~ro~h~lally to urge the blade 280 into its normally retracted position. By moving the plunger 274 distally, the opel~lor causes the cut~ng blade 280 to likewise move distally and cut the blood vessel which is retained between the yokes 258 and 260. When the operator releases the plunger 274, the plunger 274 (and thus the cutting blade 280) retracts to its origin~l position.
15 Manipulation of the handle 270 then se~al~s the prongs 262A and 262B, leaving the clips in place on the severed portion of the blood vessel, and the ~~ ligation-cutting tool 250 is removed.
The shaft 251 of the side-biting ligation-cutting tool 250 is a slender member that is longer than the working lumen of device 10. A housing 259 20 covers those mec~ni~m~ on the shaft 251 that ll~slllil the manipulations of the handle 270 and the plunger 274 at the proximal end of the side-biting ligation-cuthng tool 250 to the clipping and cutting motion, respectively, at the distal end of the side-biting ligation-cutting tool 250.
The suction-co~ tor tool 300 (FIG. 11) is used to remove body fluid 25 (e.g., blood) and reduce bleeding during the vessel harvesting procedure, and is of the type generally known in ~e art for this procedure. The suction-co~ tor tool 300 has an elong~te~ shaft 301 and includes a handle 310 attached to the ~lu~ al end of the shaft 301. A suction tube 302 is attached to the plu~lal end of shaft 301 and e~t~n~ls to the distal end of shaft 301. Atthe distal end of shaft 301 the suction tube 302 is opened for suctioning body fluids. Also attached to the proximal end of shaft 301 is a power cable 304 for supplying power for tissue co~ tion. When button 308 on handle 310 is activated, the power is supplied to the distal end of shaft 301 to c~llteri7~
5 bleeding tissue, and thus to stop bleeding. The suction-co~ tor tool 300 controls bleeding in two ways. The suction tube 302 may be used alone to suction any body fluids from the ~ section area, or the co~ tor may be used to c~llteri7~e- the bleeding tissue.
10 Method of Operation The vein harvesting device 10 and acco~ ing tools 200, 250 and 300 are used in combination for haTvesting a vessel. After proper plep~lion of the incision site, the physician makes a small incision 350 (e.g. 3cm long) over theploxil"al aspect of the blood vessel to be harvested (see FIGS. 8 and 12). The 15 blood vessel 100 is exposed and dissected for a short length under direct vision.
As seen in FIG. 12, the blood vessel 100 is then severed to expose a free end - 352 and a free end 353 (which may be clipped as shown in FIG. 12). For example, to remove a s~rhenous vein, the incision 350 will be made at the groin over the s~rhenl us vein and the vein will be dissected free from the 20 junction common femoral vein. As shown in FIGS. 8 and 12, the vein att~ehment clip 32 is inserted through the ~ secting el~ment 20, both of which are accommodated within vessel lumen 24 of vein harvesting device 10 such that the distal ends of ~i~sectin~ element 20 and vein ~tt~.hm~nt clip 32 extendbeyond the distal end of lumen 24. The free end 352 of blood vessel 100 is 25 attached to vein ~ hment clip 32 such that it is held under tension in the manner previously described. The vein harvesting device 10 is secured in a fixed position to the patient's body such as with tape. The dissecting element 20 is then advanced distally over the distal end of ~e ~tt~ollment clip 32 and over the blood vessel 100. As the ~ secting element 20 is manipulated by the operator from remote actuation handle 16, the blood vessel 100 is dissected away from ~ uuulding connective tissue.
As illustrated in FIG. 13 (which has a portion of the patient's body broken away to show the invention in operation), the dissection process 5 proceeds distally along the blood vessel 100. The body portion 14 is advanced along with the ~ ecting element 20 into the incision 350. Until this point, the operator has been viewing the procedure under direct vision. Now, the oyelalor switches to viewing the dissection process (occurring at the area immediately adjacent the distal end of the lumen 24) through the fiber optic 10 viewing device 38 located at the distal end body portion 14. ~ltem~tively, the vein device could be provided by a se~al~le scope. As previously discussed, device 38 provides adequate lighting for the operator to view the dissection andtool operations occ~ ing within the patient via the monitor. Trrig~nt is introduced as necessary ~hrough irrigation ch~nnel 28 to keep blood or other 15 body tissue from obscuring vision ~ cent the distal end of the body portion 14.
- As ~e ~licsection çlemP.nt 20 is advanced along the blood vessel 100, a side branch 102 of the blood vessel 100 may be encou-~teled before the desired length of blood vessel 100 has been ~ secte-l As previously discussed, clutch 20 87 (FIGS. 6a and 6b) prevents dissection element from being advanced when a side branch is encounl~,ed. This is particularly important when the side branch lies under vessel 100 where it may not be visible to the opel~lor. When a side branch is encoullleled before obtaining the desired length of blood vessel, the ligation-cutting tool 200 is employed to sever the side branch 102 from the 25 vessel 100 being harvested as shown generally in FIGS. 14 and 15. When a side branch 102 is re~e(l, the o~e~lor stops advancing the dissecting element 20 and the body portion 14 and, if necessary, withdraws the dissecting element 20 ~ox~llally from the side branch 102 to provide room for the operation of the ligation-cutting tool 200. The ligation-cutting tool 200 is inserted into the WO 97nl398 PCT/US96/20775 pro~ al end of working lumen 30 and advanced distally through lumen 30 and into the area distal of body portion 14. The operator positions the ligation-cutting tool over the side branch 102 such that the side branch 102 is sitting in the yokes 208 and 210 (see FIG. 14). The operator then .llal~i~llates the handle220 of the ligation-cutting tool 200 to actuate the ligation clip applicator 202.
As the prongs 212A and 212B on each of the yokes 208 and 210 move toward each other, the ligation clips 216 are çl~mpe~ about the side branch 102 therebyslopl)ing blood flow to the side branch 102.
While the side branch 102 is held securely between the yokes 208 and 210 of the ligation clip applicator 202, the operator pushes the phmger 224 to activate the cutting meçh~niem 204. As shown in FIG. 15, the cutting blade 230 thus moves distally into and through the side branch 102, thereby severing the side branch 102 from the blood vessel 100 between the ligation clips 216.
When the plunger 224 is rele~ee~l by the op~l~lor, the cutting blade 230 returnsto it's original retracted position. The handle 220 is then lllalli~ulated to s~ the prongs 212A and 212B, and the lig~*~m-cutting tool 200 is wit_drawn proxim~lly through the working lumen 30 of body portion 14. The ligation-cutting tool 200 may then be p~paled to be used again later in the procedure (i.e., reloaded with additional clips 216), if required.
After the lig~tic n-cutting tool 200 has been removed from the working lumen 230, the ~liesecting element 20 and body portion 14 are again advanced distally along the blood vessel 100 by the opelaLor using the remote actuation handle 16 (as previously described) until another side branch is reached. In this regard, ~e dissecting element 20 is large enough to pass over the clip and severed stumps of any side branches 102 which extend from the blood vessel 100. The ligation-cutting tool 200 is then used as previously described to sever~ additional side branches from the blood vessel 100. The procedure is repeated un~l the desired length of blood vessel 100 has been dissected free from all the ounding tissue and side br~nch~.s.
During the 11iesection procedure, the suction-co~ tor tool 300 is used as required to control blee~l-ng, again under the constant vigilance of the opt;lalor. During the entire procedure, the blood vessel 100 has been held in tension by vein ~tt~chmP~nt clip 32 which is biased in the ploxilllal direction by 5 spring mech~niem 36. It is, thus, unnecessary for the Optlalor to use a sep~legripping tool for the purpose of holding the vessel under tension. This frees the operator to conce~ ale on the other aspects of the tii.esection procedure. As more and more of the blood vessel 100 becomes dissected, the body portion 14 is advanced distally into the patient's body and the blood vessel 100 is moved 10 into vessel lumen 24 of body portion 14.
When the desired length of blood vessel 100 has been ~liesecte~ free from the ~ ding connective tissue, the l1iesec~in~ elemPn~ 20 is moved ~ro~ ,.ally away from the distal end of the dissected vessel se~mPnt and the side-biting ligation-cutting tool 250 is inserted into the proxilllal end of the15 working lumen 30 and advanced distally through lumen 30 into the area adjacent the distal end of body por~on 14 and the distal end of the dissected blood vessel 100. The side-biting ligation-cutting tool 250 is positioned such that the blood vessel 100 is between the first yoke 258 and the second yoke 260 of the ligation clip applicator 252, as seen in FIG. 16. When the blood vessel 20 100 is ~l~cfly positioned between yokes 258 and 260, the o~eL~lol l"~ipulates the handle 270 to actuate the ligation clip applicator 252. As the yokes 258 and 260 move toward each other, the yokes 258 and 260 act to pinch the ligation clips 266 over the distal end of the rlicsecte~ blood vessel 100 (thus ~Lo~il~g blood flow through the blood vessel 100). While the blood vessel 100 25 is held securely by the ligation clip applicator 252, the opcl~lor pushes the plunger 274 to activate the cut~ng mec~ni~m 254. The cuffing blade 280 advances between the ligation clips 266 and through the blood vessel 100 to sever the blood vessel 100 into a freed section 360 having free end 352 (FIG.
12) and a free end 361 (FIG. 16) and a rem~ining section 362. When the WO 97/21398 PCI/US96t20775 plunger 274 is rele~ce(l by the opc.~lor, the cutting blade 280 returns to it's retracted position. The handle 270 is l"al~ulated to separate the prongs 262A
and 262B, and the side-biting ligation-cuthng tool 250 is withdrawn ~lo~l,ally through the lumen 30 of body poltion 14. The tool 250 may apply ligation S clips on sections 360 and 362, or just one clip on the rem~ining section 362 of the blood vessel 100.
The freed section 360 of the blood vessel 100 is now free of all connections to the patient's body and is subst~nti~lly within vessel lumen 24 ofbody portion 14. The desired section of ~ secte~l vessel may be removed by 10 releasing the bayonet lock 39 at the proximal end of vessel lumen 24 and thenby pulling the vein through the l~ro~lal end of lumen 24. Once removed the freed section 360 of blood vessel 100 may then be plep~d for it's int~.nlle~ useor be discarded.
FIELD OF THE INVENTION
This invention relates to ~pa~alus and methods used to harvest a 5 generally cylindrical shaped tissue structure from the body of a patient. Moreparticularly, the invention is directed to an a~alalus and method for harvestinga section of a blood vessel from a patient.
BACKGROUND OF THE INVENTION
In certain circllm~t~nces it is desirable to remove sections of tubular tissue structure from a patient's body. Such tissue may be used in another part of the patient's body, may be transplanted into a second patient's body or may be discarded. As used herein, the term "tubular tissue structure" includes bloodvessels, tendons, bile ducts and any other similar tissue formation which is 15 generally tubular in structure and capable of being separated from ~ o~lding tissue. Although the invention herein will be discussed in terms of harvesting blood vessels it should be understood that the appa~alus and method described are equally applicable to harvesting other tubular tissue structure.
Vein harvesting is commonly done in connection with coronary artery 20 bypass surgery. The s~rh~nous vein is a subcutaneous vein which is often usedfor coronary artery bypass grafting, infra-in~lin~l bypass grafting and vein-vein bypass grafting. Other veins may also be used including the m~mm~ry vessel and the lessor saphenous vein. Previously, it has been necess~ry to make an incision along the full length of the vein section to be removed. The vein is 25 then freed by severing and lig~ting the branches of the vein, after which thesection of the vein can be removed from the p?~tiP.nt The full leng~ incision must then be closed, for example by s~ ring or ~t~rling Obviously, the harvesting of the vein in this m~nn~r leaves ~ fi~lrin~ scars which are cosmetically undesirable. Additionally, the large incision creates a risk of CA 022126~0 1997-11-19 WO 97/21398 PCI'/US96120M5 infection to the patient and may not heal properly, especially with those patient's who have poor circulation in their e~ ~ilies. Such an incision may create a chronic wound which will not heal.
Devices for harvesting a section of a blood vessel without creating a full length incision have been s~lggeste~ U.S. patent number 4,793,346 to Mindich discloses a device for harvesting a section of a blood vessel by m~king only small incisions at opposite ends of the blood vessel section. The device includes a guide rod which fit's inside of the vein section and a tube having anirmer diameter slightly larger than the outer diameter of the vein section to beharvested. The tube has one or more knife blades at the lea~in~ edge which are connected to an electrical supply. The vein section is removed by m~king the incision sufficiently deep so as to expose the ends of the blood vessel to be harvested. The blood vessel is cut to expose one end, the guide rod is inserted inside the blood vessel section, and the tube is placed over the end of the blood vessel section to be removed. The tube is then pushed along the blood vessel (into the patient) while rotating the tube to sever the branches of the blood vessel with the knife blade mounted at the le~1ing edge of the tube. Electrical ~iu,l~nl is supplied to the knife blades to heat the blades and thereby cauleli~e the ends of the severed branches of the blood vessel. The procedure is contimle-1 until the tube has reached the second of the two incisions. The bloodvessel is exposed and cut from the patient at the second incision. The tube is then removed from the patient with the blood vessel section inside of the tube.
The blood vessel section is then removed from the tube for further l,e~
and use as desired.
UK patent application GB 20 82 459A discloses a device for harvesting a section of a blood vessel similar to that disclosed in the ~in~lich patent.
Again, two incisions are made, one at each end of the blood vessel section to beharvested. A guide rod is inserted into the blood vessel section through one of the incisions and a tube having a cutting elçment having a cutting tool at it's WO 97/21398 PCr/US96/20775 opc.~Live end is passed over the blood vessel section and guide rod assembly.
The tube is rotated as it passes over the blood vessel section to sever the connecting br~n~lles. After the tube has passed the entire length of the blood vessel section, the section is cut away ~rough the second incision and the tube 5 is removed from the patient with the harvested section inside the tube.
Blood vessel harvesting devices of this type have certain distinct disadv~nt~ges. While they elimin~te the need for a full length incision to remove the blood vessel se~ nt two incisions, one at each end of the segment to be harvested, are required in order to remove the blood vessel se~n~nt For 10 patient's likely to develop chronic wounds, each additional incision increases the risk to the p~ti~.nt and it is desirable to keep such incisions as close to the patient's trunk as possible and to minimi~e the number and size of such incisions. A~lition~lly~ such devices are unable to adequately close off severalbranches of the blood vessel and thus are unable to adequately control bleeding.15 As a result, the patient suffers greater blood loss than is necessary. These prior devices may also remove more tissue than is n~cec.c~ry because the size of the cutting device is not readily adaptable to the ch~nges in the size of the blood vessel.
In U.S. patent number 5,373,840 to Knighton an l~lov~d device and 20 method for vein removal is disclosed which solves some of the problems associated with the use of prior art devices. KnightQn discloses an endoscope having a lumen e~t~n~ling lon~ in~lly through the scope body. The endoscope includes means for viewing an area ~ cent the distal end of the lumen. The lumen has a lateral (limen~ion large enough to accommodate the 25 blood vessel being harvested and at least one tool for use in harvesting the blood vessel. A first end of the blood vessel section to be harvested is exposedthrough an incision in the patient's body. A ~ secting tool and a gripping tool are inserted through the lumen of the endoscope and used to dissect the blood - vessel away from the ~ uul~ding connec~ve tissue of the patient's body.
Additional tools are provided for use through the lumen of the endoscope to remove body fluids and co~ te bleeding tissue, to ligate and sever side branches from the blood vessel to be harvested, and to ligate and sever a distalend of the blood vessel to be harvested when a desired length of blood vessel 5 has been dissected. Only a small incision in the patient's body is necessary to harvest a relatively long length of blood vessel in a precise and controlled m~nner using this device and procedure.
Although the '840 patent to Knighton conctih1tes a significant improvement in devices and techniques for vein harvesting, it's multiple tools 10 require more than one operator to complete the procedure. Additionally, it's single lumen design requires that the vein be contained within the same lumen as the various tools which are used duIing the ~ seclion procedure. This makes it possible for the vessel to be d~m~ge~ during the dissection process by the tools which share the same lumen. It is critical that the se~ment of blood 15 vessel being harvested is handled with great care since it is destined for reuse (as in arterial bypass). Therefore, it is desirable to isolate the vessel as much as possible from the tools which are used in the dissection.
There is a need for a device and method for vein removal which allows a vein to be harvested in an efficient and safe m~nner from the body of the 20 patient. Specifically, it would be desirable to provide a device which can beeffectively opelalt;d by a single o~alor/~lysician while at the same time protecting the segTnent of the vessel being removed from the tools which are used in the procedure.
SIJMMARY OF THE lNVENTION
In accordance with the present invention there is disclosed a device for removing a generally cylindrical tissue structure from a patient's body. The tissue structure may be a blood vessel, bile duct, tendon or other similar cylindricaVtubular tissue structure which may be removed and/or reused in ~e WO 97nl398 PCT/US96/20775 patient's body or another patient's body. The device includes an elongated body portion having distal and ploxilllal ends and at least one lumen e~tçn~ling k~ngi~l-lin~lly ther~lh~ough. The lumen is sized to accommodate the tissue structure and at least one tool used in removing the tissue structure. Means is S provided for isolating the tissue structure from the tools used in removing the tissue structure in order to protect the tissue structure from (l~m~ge The device may include viewing means to enable the operator to remotely view an area adjacent the distal end of the body portion.
The lumen of the body portion may comprise separate vessel and working lllm~.n~, the vessel lumen being sized to accommodate the vessel or similar tubular or cylindrical tissue structure and the working lumen or lllmP.n~
being sized to accommodate the tools used in the removal procedure. The separation of the vessel lumen and working lumens protects the vessel from the tools used in the procedure. ~ltPrn~tively~ the lumen may comprise a single lumen which inclndes a section which accommodates the vessel and a working section which accommodates the tools.
The vein harvesting device inc]ndes means for ~iet~k~ble connection to the vessel. The connection means may comprise an ~lligPtor clip like structure which is connected at its proxi.llal end to a tension means which ~ .c tension on the connection means and hence the vessel in the direction of the ~,lo~llal end of the body portion when the connection means is connected to the vessel. A housing is provided through which a body portion may be advanced or retracted through ~e body portion by the operator controlling an advanc~ .nt means.
The device may include one or more tools sized so that it may be accommodated within the lumen. The tool has a distal o~e,~live tip which may be used to cut a side branch of the vessel, cut the vessel, apply a ligation clip to a side branch of the vessel, apply a ligation clip to the vessel, or remove a patient's body fluids.
WO 97/21398 PCr/US96/20775 The device inch1des means for (li~secting the vessel from ~ oullding tissue. The dissection means may comprise a generally cylindrical structure having a length at least as great as the lumen e~n~ling through the body portion. The cylindrical shape defines a lumen which is sized to accommodate 5 the vessel which is drawn into the lumen of the ~ii.csection means as the vessel is dissected from ~ulluunding tissue. The tli~section means is sized to be accommodated within the vessel lumen. The device inchllles means fûr advancing or retracting the (li~section means through the lumen.
The invention also incllldes a method of removing a section of generally 10 cylindrical tissue stlucture such as a blood vessel from a patient's body. The method inch1des providing a device having an elongated body portion having distal and pluxilllal ends and at least one lumen ext~.n-ling lonpit~l~in~lly thcre~.rough. The lumen is sized to accommodate the tubular tissue structure and at least one tool used in removing the tissue structure.
A first end of the tubular tissue structure section to be harvested is exposed through an inci~ion in the patient's body. A gripping tool is inserted through the lumen and the first end of the tissue structure is gripped with the tool. The su~ ullding tissue is dissected away from the tubular tissue structurewith a (ii~sec1ing element. During the procedure the body portion and the 20 ~ sectinp~ c}ell-elll are advanced along the tubular tissue structure until adesired length of tissue structure is reached such that the ~li.csecte~l portion of the tissue structure 5;~ 5 into the lumen. During the ~ section process the tubular tissue structure is isolated from the tools used in removing the tissue structure except at the distal end of the body portion where the dissection 25 procedure is pel~lllled. When the desired length of the tissue structure is reached, the tissue structure is cut at its distal end with a transecting tool which may be inserted through the lumen. ~lt~.rn~tively, a second incision can be made through which the distal end of the tissue structure may be cut.
Where the tissue structure being harvested is a blood vessel, the method may further inclu~e advancing the body portion and a dissecting element along the vessel until a side branch of the vessel in encoulllered. A ligation member is then applied to the branch and the branch is cut between the vessel and the ligation member with a lig~ting-cutting tool inserted through the lumen. The method may also inclllde controlling bleeding as necess~ry with a bleeding control tool inserted through the second lumen. In one embo-liment the method inchl(les providing a viewing ~lement to enable viewing of the vein dissection in progress. In a fur~er embodiment the method incllldes m~ g tension on the gripping tool in the direction of the ~lo~ lal end of the body portion such that tension on the vessel is ~-~ e~ during (lissection.
BRIEF DESCRIPTION OF THE DRAWINGS
The folegoil,g and other aspects of the present invention will be best ~pleciated with reference of the detailed description of the invention which follows when read in conjunction with the acco"l~ jing drawings wherein:
FIG. la is a perspective view of the vein removal device of the present invention, FIG. lb is a fr~nented top view of the removable ~,loxilllal end of the device, and FIG. lc is a rear view of a portion of the device.
FIGS. 2a and 2b are top views of FIG. la illus~ ing ~e increm~nt~l advanc~ment of the dissecting element and the advancement of the body portion of the device, respectively.
FIGS. 3a, 3b and 3c are partially exploded views of the actuator handle, top view of ~e slctl~tor lever, and front view of the actuator lever, respectively.
FIG. 4 is a cross-sectional view of a first embodiment of the multi-lumen body portion of the device taken along line 4-4 of FIG. 1.
FIG. 5 is a cross-sectional view similar to FIG. 5 of a second embodiment of the body portion of the device of FIG. 1.
FIGS. 6a and 6b are sectional views taken along line 6-6 of FIG. la.
wo 97nl398 PCT/US96/20775 FIGS. 7a arld 7b are partial sectional views taken along line 7-7 of FIG. 6a.
FIG. 8 is a schem~tic view of the vein harvesting device of the present invention being used in the removal of the saphenous vein of a patient.
FIG. 9a is a side sectional view of a ligation-cutting tool of the present invention, with it's distal end shown enlarged in perspective, FIG. 9b is a top plan view of the distal end of the ligation-cutting tool of FIG. 9a, and FIG. 9c is a side elevational view of the distal end of the ligation-cutting tool of FIG. 9a.
FIG. 10 is a side elevational view of a side-biting ligation-cutting tool of 10 the present invention, with it's distal end enlarged in perspective.
FIG. 11 is a side elevational view of a suction-co~ tor tool of the present invention.
FIGS. 12 and 13 are enlarged perspective illustrations showing the distal end of the vein h~ ~sling tool in use during the harvesting of a blood vessel.
FIGS. 14, 15 and 16 are enlarged perspective illustrations showing the distal end of the vein harvesting device and the tools of FIGS. 9-11 in use during the harvesting of a blood vessel.
While the above-idçntified drawing figures set forth one ~lcf~lled embodiment of the invention, other embo-limPnt~ are also c~nlelllplated, as 20 noted in the discussion. In all cases, this disclosure ~lesenl~ the present invention by way of represent~tion and not by limit~tion. It should be understood that numerous other modifications and embo~liment~ can be devised by those skilled in the art which fall within the scope and spirit of the principle of this invention. It should be speçific~lly noted that the figures have not been 25 drawn to scale as it has been necess~ly to enlarge certain portions for clarity.
In other figures fragment~ry views are shown which omit certain structure for the purpose of more clearly illustrating the invention.
WO.97/21398 PCT/US96nO775 DETAILED DESCRIPTION OF THE INVENTION
The Vein H~u ve~ g Device The structure of the vein h~veslillg device of the present invention can be understood generally with reference to FIGS. 1-8. The tools which are used 5 in connection with the device dDg the vein harvesting procedure are shown in FIGS. 9-11 while FIGS. 12-16 illustrate the device and it's associated tools being used in a vein ~ v~ling procedure.
The present invention is a device and method for harvesting a section of cylindrical andtor tubular tissue structure such as a vessel from a patient's body.
10 The invention also has application for removing such tissue from animal bodies. The section may be used in another part of a patient's body or for transplanting into a second patient's body. For example, a section of the s~rh~nt~us vein may be removed for use in coronary bypass surgery. The blood vessel needs to be removed without undue ~l~m~ge to the blood vessel, as well 15 as with ~ A1 d;~..~e and trauma to the p~ient Although the description herein is directed to the h~v~sli-~g ofthe s~rhen()us vein, it is conlel~lated that the present invention could be used in connection with the efficient and effective harvesting of other vessels, tubular tissue structures or other generally cylindrical structures such as tendons from a patient's body. Structures will 20 generally be compn~e~ of human tissue although the device and methods disclosed herein would work equally well for harvesting synthetic tissue and structures.
FIG. la is a perspective view of the vein harvesting device 10 in accordance with the present invention. Device 10 includes a housing 12 25 through which an elongated body portion 14 is advanced during a vein harvesting procedure. Housing 12 and body portion 14 may be constructed of a rigid material such as metal or plastic. A remote actuation handle 16 is connected to housing 12 by a flexible biaxial cable 18. Actuation handle 16 is used to selectively advance either body portion 14 or vein dissection element w o s7nl3ss PCT/US96nO775 20 in a m~nner which will be more fully described with respect to FIGS. 2 and 3. Vein ~lissection el~ment retraction knob 22 protrudes from housing 12 and allows vein dissection elemçnt 20 to be retracted during the procedure.
As best seen in FIG. 4 which is a sectional view taken along 4-4 in FIG.
la, body portion 14 includes vessel lumen 24, viewing lumen 26, irrigation lumen 28 and working lumen 30. Each of the l unens runs longih--lin~lly through body portion 14 from an opening at the distal end to an exit port at or near the p~ al end of the body portion as seen in FIG. lc. Working lumen 30 has its exit port 31 at the ~ro2~ lal end of body portion 14. ~rigation lumen28 has an exit port 29 (FIG. la) which may be connected to a source 46 of irrig~nt (FIG. 8). The function of each lumen will be described in more detail he~ el. Body portion 14 is of sllfficiPnt size and shape to accommodate the lumens.
Lumen 24 is of a size large enough to accommodate the blood vessel which is to be harvested and dissection element 20. During the harvesting procedure after an incision has been made and the vein is ligated and clipped, a~- vein attachment clip 32 is clipped to the vessel. Vein attachment clip 32 is connecte~l via cable 34 to a spring nl~c.h~ni~m 36 which m~int~in.~ a positive tension on the vessel in the direction of the plo~ al end of the vessel lumen during the (liccection procedure. This ~limin~tes the need to use a separate gripping forceps to hold the vessel during the procedure as in U.S. patent number 5,373,840. Vessel lumen 24 may be provided with an irrig~tinn port 25 which may be connected to a source of irri~nt (not shown) to allow irrigation of the vessel being harvested, as desired.
Vessel lumen 24 is subst~nti~lly circular and has a diameter and length which may be varied depen~lin~ upon the length of the vein section to be harvested and/or the size of the patient from which the vein is to be removed.
Typically, the length of body portion 14 will be in the range of 30 to 60cm and the rli~met~r of the vessel lumen 24 will be in the range of 5-7mm.
WO 97nl398 PCT/US96/20775 Endoscope lumen 26 is sized to accommodate a fiber optics viewing device 38 which inchl-les an a~ opliate fiber optics illllmin-q-tion source.
Device 38 is positioned such that the area imme~ qtely adjacent the distal end of body portion 14 can be illnminqte~l and viewed by the operator. As seen in 5 FIG. 8, device 38 is operably connected to an externql monitor 40 which includes a suitable light source by conduit 42. Conduit 42 enters the endoscope lumen at en(loscope port 44 (FIG. la). Irrigation ch~q-nnel 28 is operable coupled to the ext~.rnql source of irrigqnt 46 via a suitable conduit 48.
Vein ~lissection element 20 is used to aid in s~p~alillg the vessel being 10 harvested from the sul,.,ullding tissue. Dissection element 20 has a generally rigid cylindrical body which may be comprised of met, l or rigid plastic. The diameter of the cylin~ric-ql body of dissection element 20 is sized to accommodate the vessel being harvested. The distal end of the tli~section elemlo.nt has a rounded or beveled distal edge 50 used to separate the blood 15 vessel from the ~w~oullding connec.*ve *ssue as the dissecting element 20 is advanced over the blood vessel. Dicsecting element 20 is provided in a - plurality of sizes for Lrrerclll si~s of blood vessels. Typical sizes would have inside diameters of 4mm, Smm, and 6mm. The cylindrical shape of dissec*on element 20 protc.;l~ the dissected portion of the vessel which is located within20 the dissection element. This feature is especially important in those embo-liment~ of the inven*on where the vessel lumen is not separate from the working lumen (i.e. FIG. Sb).
As an ~ltern~*ve to the cylindrical construction of ~i~section elemçnt 20, the structure may take the form of an elong~te~l shaft having attached at it's 25 pro~al end an ~nmll~r dissecting ring. This construction would be similar to the dissecting tool disclosed in U.S. patent number S,373,840 discussed above.
A dissection elçm~nt so cons~ucted may be inserted through vessel lumen 24 or, in the ~ltçrn~tive, may be inserted through a separate working lumen.
Utilizing a separate lumen allows the vessel to be completely isolated while in wo s7nl3ss PCT/US96nO775 the vessel lumen from the shaft of the dissection element and from all tools used in the procedure.
As seen in FIG. 4, working lumen 30 is generally arcuate in shape and positioned generally around the periphery of vessel lumen 24. Working lumen 5 30 is sized to accommodate the various tools used in the vein harvesting procedure which will be discussed in more detail with respect to FIGS. 9-11.
Typically, lumen 30 will be sized such that ~limPneion X in FIG. 4 is in the range of 5-lOmm. The shape of lumen 30 advantageously allows the tools to be used in various locations around each side and the underside of the vein.
10 Advantageously, the sep~l~ working lumen allows the tools used in the procedure to be completely separated from the ~li.esecte~l portion of the vessel in the vessel lumen thus redllcing the possibility of d~m~ein~ the vessel with the tools.
FIGS. 5a and 5b are views similar to FIG. 4 of ~ltçrn~tive configurations 15 for body portion 14. Tnete~ of a single arcuate working lumen 30 the body portion is provided with mllltiple working hlmP.ne 30A and 30B in FIG. 5a. In - FIG. 5b the working vessel lumens are combillcd into a single lumen having wo.killg sections 30C and 30D and vessel section 24A..
Body portion 14 of FIG. 5a is similar to that of FIG. 4 in that the vessel 20 lumen 24 is se~ te from the working lumen 30A and 30B. The embo-liment of FIG. Sa allows the tools used in harvesting the vein to be inserted on eitherside of the vessel lumen 24. The size and shape of working lllmPn~ 30A and 30B is selected to accommodate the tools used in the procedure. In the embodiment of FIG. 5a the lumens 30A and 30B are generally circular in cross-25 section and have a (1i~mr.t~r in the range of about 5-lOmm.
The embodiment of body portion 14 of FIG. 5b has a single combined working and vessel lumen with working sections 30C and 30D and vessel section 24A. Section 30C and 30D are of a size and shape to accommodate the tools used in the procedure. The vessel is protected from the tools by dissection element 20. Additionally, the vessel may be protected by sh~ring (i.e. as by ~ owillg) the junctions between the working sections and the vessel section such that the tools may not subst~nti~lly enter the vessel section. Other means of protecting the vessel may be employed such as by inl~ le 5 paItitioning the working sections from the vessel section.
Vein alt~rhment clip 32 is used to hold and retain the vessel being harvested during the procedure. Vein ~tt~çhm~nt clip 32 includes first and second opposed jaws 52 and 54, respectively. The jaws are tensioned towards the closed position similar to an ~llig~tQr clip which allows the jaws to obtain a 10 firm grip on the vessel. ~lt~m~tively, a l~tching mech~ni~m may be provided which locks the jaws in a set position. Spring mech~ni~m 36 m~int~in~ a positive ten~ion on vein ~tt~rhm~nt clip 32 through cable 34 towards the lal end of lumen 24 thus m~ tension on the vessel during the course of the ~ section procedure. Spring meçh~ni~m 36 is located within a 15 removable con~ lel 37 which is connecte~ to the plo~ al end of vessel lumen 24 by a bayonet lock mecl-~ni~... 39. Cont~iner 37 may be removed to allow - access to the dissected vein by pushing housing 37 towards the distal end of body portion 14 while twisting the housing 90~ clockwise.
As best seen in FIGS. 3a, 3b and 3c remote actuation handle 16 is a 20 scissors-type actuator and includes a lever 56. Lever 56 is positioned so that it may be moved to the right or left by the thumb of the operator. Lever 56 is used to engage one of two cables, 58 and 60, one of which is connected through biaxial cable 18 to a body portion advancement mech~ni~m 62 and the other of which is connected to a dissection element advancement meçh~ni~m 64 25 (FIGS. 6a and 6b). For example, the operator may choose to advance body portion 14 by moving lever 56 to the left. Lever 56 includes notches 66A and 66B which acco,~ odate cables 58 and 60, respectively. When lever 56 is moved to the left as shown in FIG. 3c cable 58 fits within notch 66A. A stop 68 is provided at the end of cable 58 which is larger than notch 66A so ~at WO 97/21398 PCI'/US96/20775 when the ope~lor squeezes the handles of the scissors-type actuating handle together cable 58 is retracted from biaxial cable 18. Similarly, a stopped 70 isprovided on cable 60 so that when lever 56 is moved to the right cable 60 may be retracted by sqvee7~in~ scissors-type actuation handle 16. Thus, by moving 5 lever 56 to the left or the right the opelalor can select whether to advance body portion 14 or ~iiccection elPment 20.
The details of the body portion advancem~nt meçh~nicm 62 and dissection element mech~nicm 64 are shown in FIGS. 6a, 6b, 7a and 7b. FIGS.
6a and 6b are cross-sectional views of the interior of the housing 12. Body 10 portion advancement mech~nism 62 incl~ ec ratchet wheel 72 fixedly connected to a spoked wheel 74 which rotates about an axle 73. Axle 73 is fixedly mounted to housing 12 in a m~m~Pr not shown in FIGS. 6a and 6b in order to simplify the Figures for purposes of clarity. Wheel 74 has spaced along its cir~ f~ence a plurality of generally circular pegs 76. Similarly, 15 dissection element advancement mech~nicm 64 includes a toothed ratchet wheel 78 fixedly connected to a spoked wheel 80 having a plurality of pegs 82 - spaced along its ci~cu~lrelellce. In a m~nner which will be described in more detail with respect to FIGS. 7a and 7b, retraction by the operator of cable 58 a~h~tçs body portion advancement meçh~ni~m 62 G~llsing body portion 14 to 20 advance in the distal direction through housing 12 while retraction of cable 60 causes ~licsection elem~nt advancemP-nt me~ ni~m 64 to advance dissection element 20 through lumen 24.
FIGS. 7a and 7b are fr~..F ~ cross-sectional views of dissection element advancPment mechA~ ... 64 showing cable 60 in the e~tPntle~l position 25 (FIG. 7a) and in the retracted position (FIG. 7b). Spokes 82 along the ci~ lrelellce of spoked wheel 80 extend through a slot 86 in body portion 14 (FIGS. 4 and 5) and align with mating openings 84 on the surface of dissection elçmP.nt 20. Therefore, rotation of spoked wheel 80 causes either advancement or retraction of ~iicseclion element 20 depending upon direction of rotation.
wo. s7nl3ss PCT/US96nO775 Rotation of spoked wheel 80 may be n~ ed by retraction of cable 60 by the oy~atol manipulating remote ~c~l~tQr 16 in the apyropliate m~nner. If lever 56 is moved to the right to engage cable 60 act~l~tion of the scissors-type actuator handle 16 will cause a retraction of cable 60. Cable 60 exten-lc 5 through biaxial cable 18 into housing 12 through a fixed member 86 which is either a portion of the housing or fixed thereto. Fixed member 86 has a plug 88 which acts as a stop for a spring 90. Cable 60 extendc through plug 88 and spring 90 and is fixedly connected to a movable cylinder 92 ratchet arm 94 is movably cormected to one side of cylinder 92. A Ratchet arm 94 pivots about a 10 point 96 and is positioned such that its ll~lllUW distal tip 97 mates with teeth 98 on toothed ratchet wheel 78.
When cable 60 is in the e~ten~led position as shown in FIG. 7a the distal tip 97 of ratchet arm 94 eng~s one of the teeth 98A on toothed wheel 78.
When cable 60 is retracted by the ~ytlalor~ cable 60 moves tow~ds the lS operator in the m~nner shown in FIG. 7b. Retraction of cable 60 in the direction of arrow 500 causes cylinder 92 to move in the direction of arrow 502. Ratchet arm 94 which is en~gecl by tooth 98A and causes both toothed wheel 78 and spoked wheel 80 to rotate in the direction of arrow 504. One squeeze of remote ~ct~tor handle 16 causes spoked wheel 80 to rotate an 20 amount cc"resyonding to the (1iepnce between teeth on toothed wheel 78.
Preferably, each squeeze of the ~c~ tion handle will cause the dicsection element to advance 5mm. This is a significant feature of the present invention since * allows the o~t,~tor to precisely and accurately control the advancement of the ~licsection element (or the body portion) in discreet increm~nt~l steps.
25 When the remote ~ch~tor handle 16 is rele~ced cylinder 92 returns to it's original position (shown in dotted line in FIG. 7b) due to the force exerted by spring 90. Pivot arm 96 is constructed so that it is fixed with respect to rotation towards the left side of FIG. 7b but will rotate towards the right side of FIG.
7b. Thus, when cylinder 92 moves to the position it occupied in FIG. 7a as WO 97~1398 PCT~US96/20775 shown in dotted line in FIG. 7b, pivot arm 96 will ride over the surface of the next tooth 98B. It thus returns to the position of FIG. 7a and is ready for the next increm~nt~l adv~ncement of dissection elem~.nt 20.
Body portion 14 is advanced in a m~nner similar to that of tliesectinn 5 element 20. The only LLrelence being that pegs 76 of spoked wheel 74 are aligned to engage with mating openings 99 in body portion 14. Lever 56 is moved to the right so that activation of scissors-type handle 16 will cause incrçmçnt~l advancement of body portion 14.
As best seen in FIGS. 6a and 6b retraction knob 22 iS provided to enable 10 ~ section element 20 to be retracted by the opel~lol during the vein harvesting procedure. In the prefelled embodiment vein ~issection element 20 iS advanced in 5mm increments to a length of about 5cm past the distal end of the body portion as shown in FIG. 2a. Once the dissection elem~ont 20 has been extlo.n~led a desired distance beyond the dishl end of body portion 14, body 15 portion 14 is advanced as shown in FIG. 2b. As seen in FIGS. 6a and 6b a suit,able clutch 87 is provided to pl~,.,nl ~ section elem~nt 20 from being - advanced when a side branch is encuun~ d. Clutch 87 may be of conventional const~uction and function to cause toothed ratchet wheel 78 to slipwith respect to spoked wheel 80 if the resistance in the advancement of 20 dissect,ion elem~nt 20 exceeds a pre-lel~ ...;. ,ed level which may cause d~m~ge to the side branch. When a side branch is encou,lL~ed or when the desired length of vessel has been obtained llis~ection element 20 may be retracted.
Retraction of dissection element 20 iS accomplished as shown in FIG. 6b by depressing retraction knob 22 in the direction of housing 12. Knob 22 iS
25 connected to shaft 81 which e~tPn~ls through a shtionary guide 83. Knob 22 and shaft 81 are biased in the position shown in FIG. 6a by a spring 85. When knob 22 is depressed as in ~e direction of arrow 508 in FIG. 6b shaft 81 causes toothed ratchet wheel 78 to become disen~e~l from pivot arm 96. Thus rohtion of knob 22 in a cou~llelclockwise direction as shown by arrow 510 CA 022126~0 1997-11-19 causes spoked wheel 80 to rotate in a direction opposite to that shown by arrow 505 in FIG. 7b. This correspondingly causes tli~section elem~nt 20 to move in a direction opposite arrow 506 thus resnlting in retraction of dissection element 20.
S
The Tools As shown in FIG. 8 when device 10 is used to harvest a blood vessel such as a saphenous vein 100, the device is used in conjunction with several tools. These tools are inserted into the working lumen 30 (FIG. 4), 30A, 30B
10 (FIG. 5a), or sections 30C, 30D (FIG. 5b) of body portion 14 at an entrance port (i.e. port 31, FIG. lc) located at the ~io~ lal end of the lumen. T_is allows the tools to be isolated from the vein during the dissection procedure tofurther protect the vein from any ~m~ge from tools being inserted, retracted or ~l~ipulated during the course of the procedure. A ligation-cutting tool 200 15 (FIG. 9) is used when severing side branches 102 from the blood vessel 100. Aside-biting ligation-cutting tool 250 (FIG. 10) is used to transect the blood vessel 100 when the dissection is completed. Finally, a suction-co~g~ tor tool 300 (FIG. 11) is used to control bleeding during the procedure.
The ligation-cutting tool 200 (FIG. 9a, 9b and 9c) is used to sever and 20 seal side branches on the vessel being harvested. The ligation-cutting tool 200 has an elon~te~ shaft 201, with a lig~tiQn clip applicator 202 and a cutting mech~ni~m 204 at the distal end of the sha~ 201. The ligation clip applicator 202 includes a first yoke 208 and a second opposed yoke 210. Each yoke 208 and 210 is in tum divided into two sections. Each yoke 208 and 210 is forked 25 at it's distal end, forming two opposed prongs 212A and 212B on the yokes 208and 210, respectively. The prongs 212A and 212B on the yokes 208 and 210 are parallel to each other and generally aligned with the longitll~lin~l axis of the ligation-cutting tool 200. The yokes 208 and 210 and the prongs 212A and 212B thereon oppose each other and serve to apply ligation clips 216 (see WO 97/213g8 PCT/US96/20775 FIGS. 9b and 9c) to a side branch 102 being severed. The opposing prongs 212A and 212B of each yoke 208 and 210 contain two grooves 214 respectively, to securely hold a ligation clip 216 therein. When the ligation clips 216 are thus held between the opposing prongs 212A and 212B of yokes 5 208 and 210, the generally U-shaped ligation clips 216 aid the operator in properly ~ligninp; the ligation-cutting tool 200 and the side branch 102 to be ligated by providing an al)u~ el-l for the side branch 102 when side branch 102 is positioned between yokes 208 and 210. When the yokes 208 and 210 are biased towards each other in a conventional m~nner, the ligation clips 216 are 10 deformed to clamp onto the side branch 102 there between and the blood flow through the side branch 102 is halted at two slightly spaced apart points (e.g.,two clips are applied ~l;~ox;...~tely 0.25 inches apart). When the ligation clipapplicator 202 is activated and the yokes 208 and 210 clamp the ligation clips 216 onto the side branch 102, the side branch 102 is held securely for cutting 15 the side branch 102.
The cutting mec~ni~m 204 on the ligation-cu~ting tool 200 includes a cutting blade 230 aligned between the prongs 212A and 212B and l~loxLIllal to the ligation clips 216. The cut~ng blade 230 is norm~lly retracted (as seen in FIGS. 9a, 9b and 9c) to allow the side branch 102 to be positioned properly 20 between the yokes 208 and 210. A cutting edge 232 of the blade 230 faces the distal end of the ligation-cut~ng tool 200 and the cutting motion of the blade 230 is in a distal direction (e.g., towards the side branch 102). The blade 230 is wide enough to completely sever the side branch 102 between the two yokes 208 and 210. The cuthng mech~ni~m 204 is activated by the opelalor (as 25 described below) after the side branch 102 has been ligated (i.e., the side branch 102 has been clipped shut and blood flow halted) and while the side branch is still held securely in the yokes 208 and 210. After the blade 230 has severed the side branch 102, the blade 230 returns into it's ori~in~ retracted position.
The ligation clip applicator 202 and the cutting mech~ni~m 204 are both achl~te~l by n ~çll~ni~m.c by the proximal end of the shaft 201 of the ligation-cutting tool 200. The ligation clip applic~tor 202 is preferably actuated by a scissors-type handle 220. By sqllee7.ing the scissors-type handle 220, the 5 opelalor causes each set of prongs 212A and 212B on the yokes 208 and 210 to be moved together, thereby CO~ SSi,lg their respective ligahon clip 216 about the side branch 102 of the blood vessel 100 as described above. The scissors-type handle 220 includes a l~tçhing mech~ni~m 222 which serves to secure the handle 220 and thus the ligation clip applicator 202 in a closed or 10 clamped position. While the ligation clip applicator 202 is held in a clampedposition, the cutting mech~ni~m 204 is ~ct l~te~ preferably by a plunger 204 located at the proximal end of the lig~tion-cutting tool 200. The plunger 224 isoperably conn~cted to the cutting blade 230 and biased pro~ ally to urge the blade 230 into it's normally retracted position. By moving the phlngçr 224 15 distally, the ope~lor causes the cutting blade 230 to likewise move distally and cut the side branch 102 of the blood vessel 100 which is ret~ine~l between the - yokes 208 and 210. When the o~ tor releases the plunger 224, the plunger 224 (and thus the cutting blade 230) retracts to it's original position.
Manipulation of the handle 220 then se~aldl~s the prongs 212A and 212B, 20 leaving the clip in place on the severed portions of the side branch 102 and the lig~tion cutting tool 200 is removed or relocated for reuse (the clips may be fed into place in the grooves of the prongs from a suitable clip m~g~7.ine not shown) to enable multiple lig~tion~ without removing the tool from the body.
The shaft 201 of the lig~ting-cut~ng tool 200 is a slender member that is 25 longer than the working lumen (30 in FIG. 4, 30A, 30B in FIG. Sa, 30C, 30D inFIG. Sb). A housing 209 covers those mech~nicm.~ on the shaft 201 that ll~ulslllil the l..~i~)ulations of the handle 220 and the plunger 224 at the ~oxill~al end of the ligation-cutting tool 200 to the clipping and cutting motions, respectively, at the distal end of ligation-cutting tool 200.
CA 022126~0 1997-11-19 WO g7/21398 PCT/US961~0775 The side biting-ligation-cutting tool 250 (FIG. 10) is used to sever and seal the distal end of the vessel being harvested. The side-biting ligation-cutting tool 250 is identical in operation to the ligation tool 200, except that the operative components at the distal end of the tool 250 are oriented generally 5 normally to the axis of the tool 250. As seen in FIG. 10, the side-biting ligation-cutting tool has an elong~te~l shaft 251, with a ligation clip applicator 252 and a cutting mech~ni~m 254 at the distal end of shaft 251. The ligation clip applir~tor 252 incl~l~es a first yoke 258 and a second, opposed yoke, 260.
Each yoke in turn is forked at it's distal end, forming two opposed prongs 262A
10 and 262B, respectively. The prongs are aligned generally parallel and each has two grooves 264 to retain ligation clips between each opposed pair of prongs 262A and 262B. The structure and operation of the ligation clip applicator 252 is similar to that illu~llaled in FIGS. 9b and 9c for the ligation-cutting tool 200.
The yokes 258 and 260 and the prongs 262A and 262B thereon oppose 15 each other and serve to apply lig~-on clips not shown in FIG. 10 to the distal end of the se~nent of the blood vessel being severed. When the ligation clips are thus held between the opposing prongs 262A and 262B of yokes 258 and 260, the generally U-shaped lig~tion clips aid in positioning and properly ~li~ing the side-biting ligation-cutting tool 250 and the blood vessel to be 20 transected by providing an abutment for the blood vessel when the blood vessel is positioned in the yokes 258 and 260. When the yokes 258 and 260 are moved towards each other, the ligation clips are clamped onto the blood vessel there between and the blood flow through the blood vessel is halted at two slightly spaced-apaIt points (e.g., two clips are applied ~plox;~ tçly 0.25 25 inches apart). When the ligation clip applicator 252 is activated and the yokes 258 and 260 clamp the ligation clips onto the blood vessel, the blood vessel is also held securely for cutting the blood vessel.
T_e cut~g mech~ni~m 254 on the side-biting ligation-cutting tool 250 includes a cutting blade 280 aligned between the prongs 262A and 262B.
Again, the structure of the cutting meçh~ni~m for the tool 250 is ~quite similar to that illustrated in FIGS. 9b and 9c for the ligation-cut~ng tool 200. The blade 5 280 is positioned such that a cutting edge 282 of the blade 280 does not intP.rfere with the ~ nm~nt of the blood vessel between the yokes 258 and 260.
The cutting blade 280 is normally retracted (as seen in FIG. 10) to allow the blood vessel to be positioned properly between yoke 258 and 260. The cutting edge 282 of the blade 280 faces in a transverse direction from the shaft 251 of 10 the side-biting li~tion-cut~ing tool 250, and the cutting motion of the blade 280 is in a transverse direction (e.g., toward the blood vessel). The blade 280 is wide enough to completely sever the blood vessel between the two yokes 258 and 260. The cutting meçh~ni~m 254 is activated after the blood vessel has been ligated (the blood vessel has been clipped shut and the blood flow halted) 15 and while the blood vessel is still held securely in the yokes 258 and 260.
After the blade 280 has severed the blood vessel, the blade 280 returns to its '~ original retracted position.
The p~ diL~rence between the tool 200 and tool 250 is that the distal operative portion of the tool 250 is oriente~ at an angle generally 90 20 degrees opposed to the axis of the shaft 251 of the tool 250. The yokes 258 and 260 are thus ori~nted to straddle a blood vessel ~rten-1ing generally parallel to the shaft 251 to apply li~;~tion clips thereto. After clips are applied, the yokes contimle to hold the blood vessel to permit severing of the vessel using the blade 280. O~her than the revision in orientation of the distal portion of the 25 ligation-cutting tool 250, it operates in the same m~nner as the ligation-cutting tool 200.
The ligation clip applicator 252 and the cutting meGh~ni~m 254 are both actuated by mech~nism~ at ~e proximal end of the shaft 251 of the ligation-cut~ng tool 250. The li~tion clip applicator 252 is preferably actuated by a scissors-type handle 270. Sqnee7ing of the scissors-type handle 270 causes each pair of prongs 262A and 262B on the yokes 258 and 260 to move together, thereby compressing their respective ligation clips about the blood vessel. The scissors-type handle 270 includes a l~tching meçh~ni~m 272 which 5 serves to secure the handle 270 and thus the ligation clip applicator 252 in aclosed or clamped position. While the ligation clip applicator is held in a clamped position, the lig~tinn cutting meçh~ni~m 254 is actuated, preferably by a pllmger 274 located at the ~o~ al end of the ligation-cutting tool 250. The plunger 274 is operably connected to the cutting blade 280, and biased 10 ~ro~h~lally to urge the blade 280 into its normally retracted position. By moving the plunger 274 distally, the opel~lor causes the cut~ng blade 280 to likewise move distally and cut the blood vessel which is retained between the yokes 258 and 260. When the operator releases the plunger 274, the plunger 274 (and thus the cutting blade 280) retracts to its origin~l position.
15 Manipulation of the handle 270 then se~al~s the prongs 262A and 262B, leaving the clips in place on the severed portion of the blood vessel, and the ~~ ligation-cutting tool 250 is removed.
The shaft 251 of the side-biting ligation-cutting tool 250 is a slender member that is longer than the working lumen of device 10. A housing 259 20 covers those mec~ni~m~ on the shaft 251 that ll~slllil the manipulations of the handle 270 and the plunger 274 at the proximal end of the side-biting ligation-cuthng tool 250 to the clipping and cutting motion, respectively, at the distal end of the side-biting ligation-cutting tool 250.
The suction-co~ tor tool 300 (FIG. 11) is used to remove body fluid 25 (e.g., blood) and reduce bleeding during the vessel harvesting procedure, and is of the type generally known in ~e art for this procedure. The suction-co~ tor tool 300 has an elong~te~ shaft 301 and includes a handle 310 attached to the ~lu~ al end of the shaft 301. A suction tube 302 is attached to the plu~lal end of shaft 301 and e~t~n~ls to the distal end of shaft 301. Atthe distal end of shaft 301 the suction tube 302 is opened for suctioning body fluids. Also attached to the proximal end of shaft 301 is a power cable 304 for supplying power for tissue co~ tion. When button 308 on handle 310 is activated, the power is supplied to the distal end of shaft 301 to c~llteri7~
5 bleeding tissue, and thus to stop bleeding. The suction-co~ tor tool 300 controls bleeding in two ways. The suction tube 302 may be used alone to suction any body fluids from the ~ section area, or the co~ tor may be used to c~llteri7~e- the bleeding tissue.
10 Method of Operation The vein harvesting device 10 and acco~ ing tools 200, 250 and 300 are used in combination for haTvesting a vessel. After proper plep~lion of the incision site, the physician makes a small incision 350 (e.g. 3cm long) over theploxil"al aspect of the blood vessel to be harvested (see FIGS. 8 and 12). The 15 blood vessel 100 is exposed and dissected for a short length under direct vision.
As seen in FIG. 12, the blood vessel 100 is then severed to expose a free end - 352 and a free end 353 (which may be clipped as shown in FIG. 12). For example, to remove a s~rhenous vein, the incision 350 will be made at the groin over the s~rhenl us vein and the vein will be dissected free from the 20 junction common femoral vein. As shown in FIGS. 8 and 12, the vein att~ehment clip 32 is inserted through the ~ secting el~ment 20, both of which are accommodated within vessel lumen 24 of vein harvesting device 10 such that the distal ends of ~i~sectin~ element 20 and vein ~tt~.hm~nt clip 32 extendbeyond the distal end of lumen 24. The free end 352 of blood vessel 100 is 25 attached to vein ~ hment clip 32 such that it is held under tension in the manner previously described. The vein harvesting device 10 is secured in a fixed position to the patient's body such as with tape. The dissecting element 20 is then advanced distally over the distal end of ~e ~tt~ollment clip 32 and over the blood vessel 100. As the ~ secting element 20 is manipulated by the operator from remote actuation handle 16, the blood vessel 100 is dissected away from ~ uuulding connective tissue.
As illustrated in FIG. 13 (which has a portion of the patient's body broken away to show the invention in operation), the dissection process 5 proceeds distally along the blood vessel 100. The body portion 14 is advanced along with the ~ ecting element 20 into the incision 350. Until this point, the operator has been viewing the procedure under direct vision. Now, the oyelalor switches to viewing the dissection process (occurring at the area immediately adjacent the distal end of the lumen 24) through the fiber optic 10 viewing device 38 located at the distal end body portion 14. ~ltem~tively, the vein device could be provided by a se~al~le scope. As previously discussed, device 38 provides adequate lighting for the operator to view the dissection andtool operations occ~ ing within the patient via the monitor. Trrig~nt is introduced as necessary ~hrough irrigation ch~nnel 28 to keep blood or other 15 body tissue from obscuring vision ~ cent the distal end of the body portion 14.
- As ~e ~licsection çlemP.nt 20 is advanced along the blood vessel 100, a side branch 102 of the blood vessel 100 may be encou-~teled before the desired length of blood vessel 100 has been ~ secte-l As previously discussed, clutch 20 87 (FIGS. 6a and 6b) prevents dissection element from being advanced when a side branch is encounl~,ed. This is particularly important when the side branch lies under vessel 100 where it may not be visible to the opel~lor. When a side branch is encoullleled before obtaining the desired length of blood vessel, the ligation-cutting tool 200 is employed to sever the side branch 102 from the 25 vessel 100 being harvested as shown generally in FIGS. 14 and 15. When a side branch 102 is re~e(l, the o~e~lor stops advancing the dissecting element 20 and the body portion 14 and, if necessary, withdraws the dissecting element 20 ~ox~llally from the side branch 102 to provide room for the operation of the ligation-cutting tool 200. The ligation-cutting tool 200 is inserted into the WO 97nl398 PCT/US96/20775 pro~ al end of working lumen 30 and advanced distally through lumen 30 and into the area distal of body portion 14. The operator positions the ligation-cutting tool over the side branch 102 such that the side branch 102 is sitting in the yokes 208 and 210 (see FIG. 14). The operator then .llal~i~llates the handle220 of the ligation-cutting tool 200 to actuate the ligation clip applicator 202.
As the prongs 212A and 212B on each of the yokes 208 and 210 move toward each other, the ligation clips 216 are çl~mpe~ about the side branch 102 therebyslopl)ing blood flow to the side branch 102.
While the side branch 102 is held securely between the yokes 208 and 210 of the ligation clip applicator 202, the operator pushes the phmger 224 to activate the cutting meçh~niem 204. As shown in FIG. 15, the cutting blade 230 thus moves distally into and through the side branch 102, thereby severing the side branch 102 from the blood vessel 100 between the ligation clips 216.
When the plunger 224 is rele~ee~l by the op~l~lor, the cutting blade 230 returnsto it's original retracted position. The handle 220 is then lllalli~ulated to s~ the prongs 212A and 212B, and the lig~*~m-cutting tool 200 is wit_drawn proxim~lly through the working lumen 30 of body portion 14. The ligation-cutting tool 200 may then be p~paled to be used again later in the procedure (i.e., reloaded with additional clips 216), if required.
After the lig~tic n-cutting tool 200 has been removed from the working lumen 230, the ~liesecting element 20 and body portion 14 are again advanced distally along the blood vessel 100 by the opelaLor using the remote actuation handle 16 (as previously described) until another side branch is reached. In this regard, ~e dissecting element 20 is large enough to pass over the clip and severed stumps of any side branches 102 which extend from the blood vessel 100. The ligation-cutting tool 200 is then used as previously described to sever~ additional side branches from the blood vessel 100. The procedure is repeated un~l the desired length of blood vessel 100 has been dissected free from all the ounding tissue and side br~nch~.s.
During the 11iesection procedure, the suction-co~ tor tool 300 is used as required to control blee~l-ng, again under the constant vigilance of the opt;lalor. During the entire procedure, the blood vessel 100 has been held in tension by vein ~tt~chmP~nt clip 32 which is biased in the ploxilllal direction by 5 spring mech~niem 36. It is, thus, unnecessary for the Optlalor to use a sep~legripping tool for the purpose of holding the vessel under tension. This frees the operator to conce~ ale on the other aspects of the tii.esection procedure. As more and more of the blood vessel 100 becomes dissected, the body portion 14 is advanced distally into the patient's body and the blood vessel 100 is moved 10 into vessel lumen 24 of body portion 14.
When the desired length of blood vessel 100 has been ~liesecte~ free from the ~ ding connective tissue, the l1iesec~in~ elemPn~ 20 is moved ~ro~ ,.ally away from the distal end of the dissected vessel se~mPnt and the side-biting ligation-cutting tool 250 is inserted into the proxilllal end of the15 working lumen 30 and advanced distally through lumen 30 into the area adjacent the distal end of body por~on 14 and the distal end of the dissected blood vessel 100. The side-biting ligation-cutting tool 250 is positioned such that the blood vessel 100 is between the first yoke 258 and the second yoke 260 of the ligation clip applicator 252, as seen in FIG. 16. When the blood vessel 20 100 is ~l~cfly positioned between yokes 258 and 260, the o~eL~lol l"~ipulates the handle 270 to actuate the ligation clip applicator 252. As the yokes 258 and 260 move toward each other, the yokes 258 and 260 act to pinch the ligation clips 266 over the distal end of the rlicsecte~ blood vessel 100 (thus ~Lo~il~g blood flow through the blood vessel 100). While the blood vessel 100 25 is held securely by the ligation clip applicator 252, the opcl~lor pushes the plunger 274 to activate the cut~ng mec~ni~m 254. The cuffing blade 280 advances between the ligation clips 266 and through the blood vessel 100 to sever the blood vessel 100 into a freed section 360 having free end 352 (FIG.
12) and a free end 361 (FIG. 16) and a rem~ining section 362. When the WO 97/21398 PCI/US96t20775 plunger 274 is rele~ce(l by the opc.~lor, the cutting blade 280 returns to it's retracted position. The handle 270 is l"al~ulated to separate the prongs 262A
and 262B, and the side-biting ligation-cuthng tool 250 is withdrawn ~lo~l,ally through the lumen 30 of body poltion 14. The tool 250 may apply ligation S clips on sections 360 and 362, or just one clip on the rem~ining section 362 of the blood vessel 100.
The freed section 360 of the blood vessel 100 is now free of all connections to the patient's body and is subst~nti~lly within vessel lumen 24 ofbody portion 14. The desired section of ~ secte~l vessel may be removed by 10 releasing the bayonet lock 39 at the proximal end of vessel lumen 24 and thenby pulling the vein through the l~ro~lal end of lumen 24. Once removed the freed section 360 of blood vessel 100 may then be plep~d for it's int~.nlle~ useor be discarded.
Claims (74)
1. A device for removing a generally cylindrical tissue structure from a human or animal body, comprising:
an elongated body portion having a distal end and a proximal end, the body portion having at least one lumen extending longitudinally therethrough, the at least one lumen being sized to accommodate the tissue structure and at least one tool used in removing tissue structure; and a generally cylindrical tissue structure dissection element sized to fit within the at least one lumen, the dissection element having a lumen sized to accommodate the tissue structure and to isolate the tissue structure from the at least one tool along a substantial portion of the at least one lumen of the body portion.
an elongated body portion having a distal end and a proximal end, the body portion having at least one lumen extending longitudinally therethrough, the at least one lumen being sized to accommodate the tissue structure and at least one tool used in removing tissue structure; and a generally cylindrical tissue structure dissection element sized to fit within the at least one lumen, the dissection element having a lumen sized to accommodate the tissue structure and to isolate the tissue structure from the at least one tool along a substantial portion of the at least one lumen of the body portion.
2. The device of claim 1 further comprising means for viewing an area adjacent the distal end of the body portion.
3. The device of claim 1 further including a tissue attachment member adapted for detachable connection to the tissue structure, the attachment member being sized to fit within the lumen of the dissection element.
4. The device of claim 3 further comprising a tension element having a distal end connected to the attachment member for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the attachment member is connected to the tissue structure.
5. The device of claim 4 wherein the body portion, dissection element and tension element are configured so that the tissue structure can be removed by a single operator.
6. The device of claim 1 further including a housing through which the elongated body portion is advanced or retracted.
7. The device of claim 6 further including a body portion advancement member operably connected to the body portion for advancing or retracting the body portion through the housing.
8. The device of claim 7 wherein the body portion advancement member is configured to allow advancement or retraction of the body portion in discreet increments.
9. The device of claim 6 wherein the housing, body portion, dissection element and body portion advancement member are configured so that the tissue structure can be removed by a single operator.
10. The device of claim 1 further comprising a dissection element advancement member operably connected to the dissection element for advancing or retracting the dissection element through the at least one lumen.
11. The device of claim 10 wherein the dissection advancement member is configured to allow advancement or retraction of the dissection element in discreet increments.
12. The device of claim 10 further comprising a clutch element to prevent advancement of the dissection element if a predetermined amount of resistance is encountered.
13. The device of claim 10 further comprising a body portion advancement member operably connected to the body portion for advancing or retracting the body portion through the housing.
14. The device of claim 13 wherein both the body portion advancement member and dissection element advancement member are configured to allow advancement or retraction of the body portion and the dissection element in discreet increments.
15. The device of claim 14 further comprising a control handle operably connected to allow one hand control of both the body portion advancement member and the dissection element advancement member.
16. The device of claim 10 wherein the body portion, dissection element and dissection element advancement member are configured so that the tissue structure can be removed by a single operator.
17. The device of claim 1 wherein the at least one lumen of the body portion further comprises a first lumen and a second lumen and wherein the first lumen is sized to accommodate the tissue structure and the dissection element and the second lumen is sized to accommodate the at least one tool.
18. The device of claim 17 wherein the body portion and dissection element are configured so that the tissue structure can be removed by a single operator.
19. The device of claim 1 wherein the body portion and dissection element are configured so that the tissue structure can be removed by a single operator.
20. A device for removing a generally cylindrical tissue structure from a human or animal body comprising:
an elongated body portion having a distal end and a proximal end, the body portion having at least one lumen extending longitudinally therethrough, the at least one lumen being sized to accommodate the tissue structure and at least one tool used in removing the tissue structure; and means for isolating the tissue structure from the at least one tool in removing the tissue structure.
an elongated body portion having a distal end and a proximal end, the body portion having at least one lumen extending longitudinally therethrough, the at least one lumen being sized to accommodate the tissue structure and at least one tool used in removing the tissue structure; and means for isolating the tissue structure from the at least one tool in removing the tissue structure.
21. The device of claim 20 further comprising means for viewing an area adjacent the distal end of the body portion.
22. The device of claim 20 wherein the at least one lumen includes first and second lumens, the first lumen being sized to accommodate the tissue structure and the second lumen being sized to accommodate the at least one tool.
23. The device of claim 20 further including means adapted for detachable connection to the tubular tissue structure.
24. The device of claim 23 further comprising tension means for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the connection means is connected to the tissue structure.
25. The device of claim 24 wherein the body portion, means for isolating the tissue structure, connection means and tension means are configured so that the tissue structure can be removed by a single operator.
26. The device of claim 20 further including a housing through which the elongated body portion is advanced or retracted.
27. The device of claim 26 further including body portion advancement means for advancing or retracting the body portion through the housing.
28. The device of claim 27 wherein the body portion advancement means is configured to allow advancement or retraction of the body portion in discreet increments.
29. The device of claim 27 wherein the body portion, means for isolating the tissue structure, housing and body portion advancement means are configured so that the tissue structure can be removed by a single operator.
30. The device of claim 20 further comprising means for dissecting the tissue structure from surrounding tissue.
31. The device of claim 30 further comprising means for advancing or retracting the dissection means through the at least one lumen.
32. The device of claim 31 wherein the dissection advancement means is configured to allow advancement or retraction of the dissection means in discreet increments.
33. The device of claim 32 further compromising clutch means for preventing the advancement of the dissection element if a predetermined amount of resistance is encountered.
34. The device of claim 31 wherein the body portion, means for isolating the tissue structure, means for dissecting the tissue structure and means for advancing or retracting the dissection means are configured so that the tissue structure can be removed by a single operator.
35. The device of claim 30 further comprising means adapted for detachable connection to the tissue structure.
36. The device of claim 35 further comprising means operably affixed to the connection means for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the connection means is connected to the tissue structure.
37. The device of claim 36 wherein the body portion, means for isolating the tissue structure, means for dissecting the tissue structure, connection means and means for maintaining tension are configured so that the tissue structure can be removed by a single operator.
38. The device of claim 36 further comprising a housing through which the elongated body portion is advanced or retracted.
39. The device of claim 38 further comprising means for advancing or retracting the body portion through the housing.
40. The device of claim 39 wherein the body portion, means for isolating the tissue structure, means for dissecting the tissue structure, connection means, means for maintaining tension and means for advancing or retracting the body portion are configured so that the tissue structure can be removed by a single operator.
41. The device of claim 39 further comprising means for advancing or retracting the dissection means through the at least one lumen.
42. The device of claim 41 wherein the body portion, means for isolating the tissue structure, means for dissecting the tissue structure, connection means, means for maintaining tension and means for advancing or retracting the dissection means are configured so that the tissue structure can be removed by a single operator.
43. The device of claim 41 wherein both the body portion advancement means and dissection element advancement means are configured to allow advancement or retraction of the body portion and the dissection means in discreet increments.
44. The device of claim 43 further comprising means for controlling with one hand both the body portion advancement means and the dissection advancement means.
45. The device of claim 30 wherein the body portion, means for isolating the tissue structure and means for dissecting the tissue structure are configured so that the tissue structure can be removed by a single operator.
46. The device of claim 20 wherein the body portion and the means for isolating the tissue structure are configured so that the tissue structure can be removed by a single operator.
47. A device for removing a generally cylindrical tissue structure from a human or animal body comprising an elongated body portion having a distal end and a proximal end, the body portion having first and second lumens extending longitudinally therethrough, the first lumen being sized to accommodate the tissue structure and the second lumen being sized to accommodate at least one tool used in removing the tissue structure the first and second lumens being substantially separate so that the tissue structure is isolated from the at least one tool through a substantial portion of the body portion.
48. The device of claim 47 further comprising means for viewing an area adjacent the distal end of the body portion.
49. The device of claim 47 wherein the elongated body portion includes a third lumen extending longitudinally therethrough, the third lumen being sized to accommodate at least one tool used in removing the tissue structure.
50. The device of claim 47 further including a tissue attachment member adapted for detachable connection to the tissue structure, the attachment member being sized to fit within the first lumen.
51. The device of claim 50 further comprising a tension element having a distal end connected to the attachment member for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the attachment member is connected to the tissue structure.
52. The device of claim 51 wherein the body portion, tissue attachment member and tension element are configured so that the tissue structure can be removed by a single operator.
53. The device of claim 47 further including a housing through which the elongated body portion is advanced or retracted.
54. The device of claim 53 further including a body portion advancement member operably connected to the body portion for advancing or retracting the body portion through the housing.
55. The device of claim 54 wherein the body portion advancement member is configured to allow advancement or retraction of the body portion in discreet increments.
56. The device of claim 54 wherein the body portion, housing and body portion advancement member are configured so that the tissue structure can be removed by a single operator.
57. The device of claim 47 further comprising a dissection element having a distal tip including an annular portion, the annular portion being located distally of the distal end of the body portion and being operative to dissect the tissue structure from surrounding tissue as the annular portion is advanced along the exterior of the tissue structure.
58. The device of claim 57 wherein the body portion and dissection element are configured so that the tissue structure can be removed by a single operator.
59. The device of claim 57 wherein the dissection element is accommodated within the first lumen of the body portion.
60. The device of claim 59 further comprising a dissection element advancement member operably connected to the dissection element for advancing or retracting the dissection element through the first lumen.
61. The device of claim 60 further comprising a clutch element to prevent advancement of the dissection element if a predetermined amount of resistance is encountered.
62. The device of claim 60 wherein the dissection advancement member is configured to allow advancement or retraction of the dissection element in discreet increments.
63. The device of claim 60 wherein the body portion, dissection element and dissection element advancement member are configured so that the tissue structure can be removed by a single operator.
64. The device of claim 59 further comprising an attachment member adapted for detachable connection to the tissue structure, the attachment member being sized to fit within the lumen.
65. The device of claim 64 further comprising a tension element having a distal end connected to the attachment member for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the attachment member is connected to the tissue structure.
66. The device of claim 65 wherein the body portion dissection element, attachment member and tension element are configured so that the tissue structure can be removed by a single operator.
67. The device of claim 65 further comprising an attachment member adapted for detachable connection to the tissue structure, the attachment member being sized to fit within the first lumen.
68. The device of claim 67 further comprising a tension element having distal end connected to the attachment member for maintaining tension on the tissue structure in the direction of the proximal end of the body portion when the attachment member is connected to the tissue structure.
69. The device of claim 68 further comprising a housing through which the elongated body portion is advanced or retracted.
70. The device of claim 69 further comprising a body portion advancement member operably connected to the body portion for advancing or retracting the body portion through the housing.
71. The device of claim 70 further comprising a dissection element advancement member operably connected to the dissection element for advancing or retracting the dissection element through the first lumen.
72. The device of claim 71 further comprising a clutch element to prevent advancement of the dissection element if a predetermined amount of resistance is encountered.
73. The device of claim 71 wherein both the body portion advancement member and dissection element member are configured to allow advancement or retraction of the body portion and the dissection element in discreet increments.
74. The device of claim 73 further comprising a control handle operably connected to allow one hand control of both the body portion advancement member and the dissection element advancement member.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/570,229 US5772576A (en) | 1995-12-11 | 1995-12-11 | Apparatus and method for vein removal |
| US08/570,229 | 1995-12-11 | ||
| PCT/US1996/020775 WO1997021398A1 (en) | 1995-12-11 | 1996-12-11 | Apparatus and method for vein removal |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2212650A1 CA2212650A1 (en) | 1997-06-19 |
| CA2212650C true CA2212650C (en) | 2001-03-06 |
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ID=24278785
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002212650A Expired - Lifetime CA2212650C (en) | 1995-12-11 | 1996-12-11 | Apparatus and method for vein removal |
Country Status (6)
| Country | Link |
|---|---|
| US (4) | US5772576A (en) |
| EP (1) | EP0840576B1 (en) |
| AU (1) | AU1354897A (en) |
| CA (1) | CA2212650C (en) |
| DE (1) | DE69632686D1 (en) |
| WO (1) | WO1997021398A1 (en) |
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| US5954713A (en) | 1996-07-12 | 1999-09-21 | Newman; Fredric A. | Endarterectomy surgical instruments and procedure |
| US5899912A (en) * | 1997-12-17 | 1999-05-04 | Eaves, Iii; Felmont F. | Apparatus and method for endoscopic harvesting of elongate tissue structure |
| US6129661A (en) * | 1998-04-09 | 2000-10-10 | Smith & Nephew, Inc. | Endoscopic instrumentation with working channel |
| US6830546B1 (en) | 1998-06-22 | 2004-12-14 | Origin Medsystems, Inc. | Device and method for remote vessel ligation |
| US7326178B1 (en) | 1998-06-22 | 2008-02-05 | Origin Medsystems, Inc. | Vessel retraction device and method |
| US6976957B1 (en) | 1998-06-22 | 2005-12-20 | Origin Medsystems, Inc. | Cannula-based surgical instrument and method |
| EP0979635A2 (en) | 1998-08-12 | 2000-02-16 | Origin Medsystems, Inc. | Tissue dissector apparatus |
| WO2000045691A2 (en) * | 1999-02-04 | 2000-08-10 | Da Silva Branco Antonio Carlos | Kit for endovascular venous surgery |
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-
1995
- 1995-12-11 US US08/570,229 patent/US5772576A/en not_active Expired - Lifetime
-
1996
- 1996-12-11 AU AU13548/97A patent/AU1354897A/en not_active Abandoned
- 1996-12-11 DE DE69632686T patent/DE69632686D1/en not_active Expired - Lifetime
- 1996-12-11 EP EP96945099A patent/EP0840576B1/en not_active Expired - Lifetime
- 1996-12-11 WO PCT/US1996/020775 patent/WO1997021398A1/en active IP Right Grant
- 1996-12-11 CA CA002212650A patent/CA2212650C/en not_active Expired - Lifetime
-
1998
- 1998-06-29 US US09/107,158 patent/US6071232A/en not_active Expired - Fee Related
-
2000
- 2000-06-05 US US09/586,825 patent/US6428468B1/en not_active Expired - Fee Related
-
2002
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| CA2212650A1 (en) | 1997-06-19 |
| EP0840576B1 (en) | 2004-06-09 |
| WO1997021398A1 (en) | 1997-06-19 |
| US6428468B1 (en) | 2002-08-06 |
| EP0840576A4 (en) | 1999-03-10 |
| EP0840576A1 (en) | 1998-05-13 |
| US6071232A (en) | 2000-06-06 |
| US7066875B2 (en) | 2006-06-27 |
| DE69632686D1 (en) | 2004-07-15 |
| US20030045812A1 (en) | 2003-03-06 |
| US5772576A (en) | 1998-06-30 |
| AU1354897A (en) | 1997-07-03 |
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