CA2218661A1 - Method and apparatus for treating vascular tissue following angioplasty to minimize restenosis - Google Patents
Method and apparatus for treating vascular tissue following angioplasty to minimize restenosis Download PDFInfo
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- CA2218661A1 CA2218661A1 CA002218661A CA2218661A CA2218661A1 CA 2218661 A1 CA2218661 A1 CA 2218661A1 CA 002218661 A CA002218661 A CA 002218661A CA 2218661 A CA2218661 A CA 2218661A CA 2218661 A1 CA2218661 A1 CA 2218661A1
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- light
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- balloon
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/0601—Apparatus for use inside the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
- A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N5/067—Radiation therapy using light using laser light
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22001—Angioplasty, e.g. PCTA
- A61B2017/22002—Angioplasty, e.g. PCTA preventing restenosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/06—Radiation therapy using light
- A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
- A61N2005/0661—Radiation therapy using light characterised by the wavelength of light used ultraviolet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1007—Arrangements or means for the introduction of sources into the body
Abstract
A surgical instrument for treating a blood vessel wall following percutaneous trans-luminal coronary angioplasty (PTCA) includes an optical system (48, 50, 52) for transmitting radiant energy, preferably UV light energy, from a laser source to the distal end portion of a PTCA catheter (30), and causing the radiant energy to exit the catheter in a relatively narrow radial band. A microprocessor controlled stepping motor is used to longitudinally reposition the band along the length of the balloon (18) of the PTCA catheter to thereby expose endothelial tissue spanned by the balloon to radiation for the purpose of inhibiting smooth muscle proliferation reducing incidence of restenosis.
Description
; ;' CA 02218661 1997-10-20 ,......... --1--METHOD AND APPARATUS FOR TREATING VASCULAR
TISSUE FO~LOWING ANGIOPLASTY TO MINIMIZE RESTENOSIS
BACKGROUND OF THE INVENTION
I. Field of the I~vention: This invention relates generally to surgical instruments ~or improving the outcome o~ percutaneous translllm; n~ 1 coronary angioplasty procedures, and more particularly to a catheter having a means ~or irradiating a treatment site with radiant energy, e.g., W light, to reduce the incidences of restenosis.
-- 10II. Discussion of the Pr;or ~t: Percutaneous transll~min~l coronary angioplasty (PTCA) has become a recognized method o~ reducing the occlusion o~ blood ~ ~ vessels due to coronary artery disease. The procedure involves routing a catheter having an in~latable balloon at the distal end thereo~ through the vascular system until the balloon is positioned at the site o~ the stenotic lesion to be treated. The balloon is then in~lated to compress the atherosclerotic plaque into the wall o~ the coronary artery, thus increasing the size of the opening and enhancing blood ~low through the a~ected artery.
Approximately 400,000 angioplasty procedures are per~ormed annually in the United States to open blocked coronary arteries. However, this success~ul procedure is overshadowed by the occurrence o~ restenosis, a re---25 narrowing o~ the artery. Studies have shown that 30-~0 :percent o~ angioplasty patients experience restenosis -within six months of the angioplasty procedure. When restenosis occurs, patients may be treated with cardiovascular medications, additional angioplasty 30proc~ ~r .b ~ a55 5urg~ry, S~arrying out the angio~?lasty procedure results in damage to the endothelium and it is ~ound that the body~s natural response to such damage is a proli~eration o~ smooth muscle cells, o~tentimes resulting in restenosis.
35In U.S. Patent 5,053,033 to Richard H. Clarke, a technique is described ~or reducing incidences o~
: restenosis ~ollowing angioplasty. The patent describes a :
W~6/32986 CA 022l866l l997-l0-20 PCT~S96/05 procedure in which the blood vessel walls at the angioplasty site are irradiated with W light during the course o~ the angioplasty procedure and that the e~ect o~
such irradiation is to reduce proli~eration o~ smooth muscle cells at the site o~ the damage. In accordance with the te~h;ngs o~ the Clarke patent, the W radiation is delivered by means o~ an optical ~iber incorporated into a percutaneous catheter. The W radiation is sent down the optical fiber from a suitable laser or even a source o~
non-coherent W light. It is theorized that ultraviolet light in the 240 nm to 280 nm range, when delivered to the DNA of smooth muscle cells ef~ects cellular replication, thereby inhibiting proli~eration.
In U.S. Patent Re. 34,544 to Spears, there is described a system ~or per~orming angioplasty which also uses light energy typically in the in~rared range. In accordance with that patent, the subject is ~irst injected with a hematoporphyrin which is selectively taken up into the atheromatous plaque. Subsequently, light in the IR
range is made to impinge on the stenotic lesion, resulting in lysis o~ the plaque. A balloon catheter equipped with a ~lexible optical ~iber is used to deliver the light to the source. When the balloon is in~lated, it displaces the otherwise opaque blood allowing transmission o~ the IR
energy through the balloon to the plaque being irradiated.
While research, to date, has been limited, medical scientists have been exploring the use o~ gamma radiation in treating damage to blood vessel walls resulting ~rom angioplasty and/or atherectomy procedures.
3.0 ~either the Sp~ars Reissue Patent 34,544 nor the Clarke Patent 5,053,033 teaches an apparatus ~or providing a uni~orm exposure o~ the intimal and endothelial layers at the site o~ the treated stenosis to radiation, such as W
light, over the entire area o~ the compressed lesion, nor precise control over the exposure time. Moreover, the liquid ~illed, hollow glass tube 24 at the distal end o~
the catheter 12 in the Spears patent would be relatively ~ w~ ~ola.C~ZSO r~ltu~ /u~
~ ; - CA 02218661 1997-10-20 : -3-rigid and thus likely to cause damage to a vessel wall as the catheter carrying this structure is advanced through the vascular system. In the Clarke patent, the balloon 42 is de~lated during the attempted exposure o~ the treated tissue to W light. Hence, blood will surround the optical lens at the distal end o~ the catheter and e~ectively reduce the transmission o~ W light to the tissue to be irradiated, thereby necessitating longer exposure times.
Thus, it can be seen ~rom the ~oregoing a need exists ~or an improved instrument ~or exposing the area o~
compressed lesion to radiant energy in a controlled manner ~ollowing balloon angioplasty so as to reduce the tendency toward smooth muscle growth and restenosis. It is a principal purpose o~ the present invention to satis~y this need.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided an apparatus ~or treating the wall o~ a blood vessel ~ollowing a balloon angioplasty procedure to reduce a subsequent occurrence o~ restenosis. The apparatus comprises a conventional angioplasty catheter o~ the type having a tubular catheter body with a pro~; m~ 1 end, a distal end portion and ~irst and second lumens extending through the tubular body. An in~latable balloon o~ a predetermined length ~;men~ion is disposed proximate the - distal end portion o~ the catheter body and the interior o~
the balloon is in ~luid commlln;cation with the ~irst lumen.
Both the distal end portion o~ the tubular catheter body and the in~latable balloon are ~abricated ~rom a plastic 3~ ~te~i~l ~ha~ is hi~hly t~ncmissive at the waveleng~h o~
the radiant energy being employed.
An elongated; ~lexible, radiant energy-emitting ~iber, having a proximal end and a distal end, is coaxially disposed in the second lumen o~ the balloon catheter and it extends ~rom the proximal end thereo~ into its distal end portion. The radiant energy ~iber is terminated in a radiant energy di~using element whose length ~im~n~ion is W096l32986 CA 022l866l l997-l0-20 PCT~S96/05~7 ,_ ,~
less than the predetermined length dimension o~ the balloon. Furthermore, the radiant energy transmissive ~iber is longitudinally displaceable within the second lumen o~ the angioplasty catheter. A displacement control means is coupled to the pro~; m~ 1 end of the balloon catheter and to the fiber ~or controllably, longitudinally displacing the radiant energy di~using and emitting element along the predetermined length dimension of the balloon such that the radiant energy, typically W light in the 240 to 280 nm wavelength range, or perhaps gamma radiation, transmitted through the distal end portion of the tubular catheter body and through the balloon material can be made to bathe the site of the compressed lesion in a series of controlled steps as the balloon is periodically in~lated and deflated so as to provide ade~uate blood supply to tissues downstream of the site being treated. By so moving the radiant energy diffusing member within the con~ines o~ the balloon, the irradiated tissue is not subjected to excessive temperature rises.
In accordance with a pre~erred embodiment o~ the invention, the controlled longitudinal displacement o~ the radiant energy di~using element along the length ~;m~n~ion o~ the balloon is achieved using a microprocessor controlled stepping motor connected in driving relationship with a lead screw which, when rotated, is e~ective to translate the optical fiber within the second lumen of the balloon catheter.
DESCRIPTION OF THE DRAWINGS
Further ~eatures and objects o~ the invention will become ~pr~nt to t~nse s~;l led in the art ~rom the ~ol~cw~ng de~ailed description of a preferred er..bodlr.ent, especially when considered in conjunction with the accompanying drawings in which like numerals in the several views re~er to corresponding parts.
Figure 1 is a partially cross-sectioned view o~ the surgical instrument in accordance with the present invention;
W~ ~ol~ZY~ r~llu~Y~>lu~
: ~ ' CA 02218661 1997-10-20 Figure 2 is a cross-sectional view taken along the line 2-2 in Figure 1; and Figure 3 is a side-elevation o~ a device ~or controlling the displacement o~ a radiant energy di~using element located within the distal end portion o~ the catheter.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Re~erring first to Figure 1, there is identi~ied generally by numeral 10 an instrument especially designed ~or delivering radiant energy to a site within the vascular system ~ollowing a balloon angioplasty procedure on a patient. It is seen to comprise an elongated, ~lexible tubular catheter body 12 having an outer diameter o~ about 0.040 in. and a wall thickness o~ approximately .005 in.
The catheter body is pre~erably extruded ~rom polyethylene plastic and, as is illustrated in the cross-sectional view o~ Figure 2, has at least ~irst and second lumens 14 and 16, respectively.
Appropriately bonded to the exterior sur~ace o~ the tubular body 12 at the distal end portion thereo~ is an in~latable expander member or balloon 18, which is circum~erentially bonded at its ends 20 and 22 to the tube 12 at spaced apart locations. In accordance with the present invention, the expander member 18 is also pre~erably ~ormed ~rom polyethylene, a plastic exhibiting - ~high radiant energy transmissivity in the W light portion o~ the spectrum. The expander member 18 may typically be anywhere ~rom 20 to 30 mm in length and it spans one or more ports 24 ~ormed through the wall o~ the catheter body 30 12 ~ r~mml-n~ r~t;n~ ~i~h thr~ ~irst lumen ~4 ~Figure 2), i.e., the in~1ation lumen. It is also ~ound expedient to locate radiopaque marker bands 26 and 28 on opposite ends o~ the expander member to ~acilitate the positioning o~ the expander member relative to a lesion to be treated under 3S ~1uoroscopy.
Disposed at the proximal end o~ the catheter body 12 is a molded plastic hub member 30 which is generally wog6/32s86 CA 02218661 1997-10-20 PCT~S96/05287 tubular and which has a Touchy-Borst type compression fitting 32 disposed near its proximal end. The hub 30 also includes first and second ports 34 and 36 having Luer fitting for connection to liquid supply tubes (not shown).
The port 34 is in fluid communication with the inflation lumen 14 and when a fluid, such as normal saline, is injected under pressure into that port, it ~lows through the lumen 14 and the ports 24 in the catheter to effect in~1ation of the expander member 18. The port 36 is in fluid communication with the lumen 16 which extends all the way to the distal end 38 of the balloon catheter. By pumping saline with a roller pump at a low rate of about 2-4 cubic cms per minute into the port 36, the flow prevents blood from entering the distal end 38 of the catheter.
Extending through the compression fitting 32, the tubular hub 30 and through the second lumen 16 of the instrument 10 is an elongated, flexible, radiant energy-tr~ m;~sive fiber assembly 40. Where the radiation source to be employed is a source of W light, the radiant energy 20 tr~n.~ sive fiber may comprise a core member 42 including a quartz fiber 44 covered by a Teflon jacket 46. The wall thickness of the jacket may be approximately 0.003 in. The quartz fiber has a distal end 48 and the jacket 46 extends in the distal direction beyond the end 48 of the fiber ~or 25 a distance of about 6 mm and forms a radiant energy di~fusing and emitting element 50. A radiopaque plug 52 is fitted into the distal end of the element 50.
Starting a predetermined distance proximal of the distal plug 52 and extending proximally through the 3~ c~m~ressi~n fi~ting 32 of the hub 30 is an outer tllh-reinforcing member 54, which preferably comprises a stainless steel tube whose O.D. is about 0. 014 in. The stainless steel reinforcing member 54 tightly surrounds the jacket 46 of the quartz fiber 44 and because of its relative rigidity compared to that o~ the quartz fiber 44, it permits the radiant energy transmissive fiber assembly 40 to be pushed longitudinally through the lumen 16 o~ the W ~ 96/32986 PCT/US96/0~287 : -7-catheter body 12 when a ~orce is applied at the proximal end o~ the radiant energy transmissive ~iber assembly. The length of the core 42 that extends beyond the distal terminus o~ the reinforcing member 54 may be approximately 13 in. and, as such, the assembly 40 exhibits su~ficient "pushability" and "torqueability" to permit the unrein~orced portion to traverse the lumen 16 o~ the tubular body 12. I~ gamma radiation is to be delivered to the a~fected area o~ the blood vessel, a suitable source o~
gamma radiation, such as cobalt 60 particles may be embedded in the plastic at the distal end o~ an elongated ~lexible ~iber.
With continued re~erence to Figure 1, there is shown attached to the portion o~ the radiant energy-transmissive ~iber assembly 40 extending proximally beyond the compression ~itting 32 an adjustable stop member 56. The stop member 56 can be moved longitudinally along the ~iber assembly 40 to a desired position and then locked in place by rotating the knurled grip 58, thereby e~ectively establishing a predetermined travel distance between the stop member 56 and the proximal end o~ the hub 30. This also de~ines the extent o~ displacement o~ the di~using element 50 in the distal direct-ion.
The radiant energy-transmissive ~iber assembly 40 extends proximally beyond the stop member 56 and passes through a strain relie~ member 60, terminating in a standard connector 62. Connector 62 is adapted to couple with the output o~ a radiant energy source (not shown).
The radiant energy source is pre~erably a pulsed or 3~ contin~ c ~av~ l~c~ ~p~hl~ ~ producing an O-lt~t beam at an appropriate W wavelength. It has been ~ound that a wavelength in the range o~ ~rom 240 nm to 280 nm covers the range exhibiting e~icacy in inhibiting smooth muscle tissue growth.
The W light emanating ~rom the laser source passes through the quartz ~iber 44 to its distal end 48. The Te~lon di~using element 50, comprising the jacket W096/32986 CA 022l866l l997-l0-20 PCT~S96/OS287 extension, is found to uniformly diffuse the W light exiting the end o~ the quartz fiber. Because the tu~ular body 12 and the expander member 18 are fabricated from a highly W light transmissive material (polyethylene), the W light emanating ~rom the di~user 50 causes a radial band o~ light, approximately the length of the jacket extension, to radiate out through the expander member to impinge upon the intimal tissue. By controlling the displacement of the ~iber in the axial direction, the emanating band o~ W radiation can be made to traverse the ;: entire length of the expander member continuously or in discrete steps to thereby expose the adjacent vessel wall to the radiant energy. It is possible, of course, to also rotate the radiant energy transmissive fiber assembly 40 within the lumen of the catheter when and if the radiation pattern exiting the diffusing member is not annularly symmetrical.
Referring next to Figure 3, there is shown an apparatus ~or controlling the movement of the radiant energy-transmissive ~iber assembly 40 within the lumen 16 of the instrument 10. The apparatus comprises a stationary clamping member 70 having a longitudinal slot 72 formed therein for receiving the tubular barrel of the hub 30. A
: slide plate 74, when retracted, permits the tubular barrel to be inserted in the slot 72 and when again extended, securely clamps the hub member against longitll~;n~l displacement. The stationary clamping member 70 is affixed to the distal end o~ a guide member 76 which passes through a slot ~ormed in a movable clamping member 78. The movable cl~mr;ng member is designed to engage the adjustable stop 56 so that when the movable clamping member 78 is displaced in the direction of the double-headed arrow 80 along the guide 76, the elongated, flexible, light transmissive fiber assembly 40 is likewise translated.
To controllingly displace the moveable clamping member 78, there is provided a stepper motor 82 which is mounted on a base 84 and which is connected in driving relationship WO9~/32986 CA 02218661 1997-10-20 PCT~S96105287 _ g_ to a threaded lead screw 86 supported at its ~ree end in a bearing 88 mounted on a rectangular post 90, also secured to the base 84. The lead screw 86 passes through a threaded bore 92 formed through a rectangular nut 94. The nut is constrained against rotation by a suitable means, such as a Nylon slide bearing 96 that is a~ixed to the nut 94 and which slidingly cooperates with a sur~ace o~ the base 84. An elongated segment o~ piano wire 98 is connected between the traveling nut 94 and the moveable -. 10 clamping member 78. More particularly, the piano wire 98 passes through a bore 100 ~ormed through a block 102 a~ixed to the post 90. A tubular sheath 104 surrounds the piano wire between the block 102 and a wire guide 106 ~ormed as a part o~ the guide member 76. The piano wire 98 is then secured to the moveable clamping member 78 as illustrated.
An electronics module 108 is connected to the motor and contains a microprocessor chip and associated memory ~or storing a program o~ instructions controlling the operation o~ the stepper motor 82. The microprocessor is programmed to supply stepping pulses at a predetermined rate to the motor 82 with each pulse producing a rotation of the lead screw through a predetermined arc and a corresponding translational displacement o~ the nut 92 and, there~ore, the axial disposition o~ the optical ~iber ~ assembly 40 within the lumen 16 o~ the i~strument. The microprocessor is programmed in a known manner to cause the stepper motor to drive the lead screw in accordance with a predetermined time pro~ile, such that the di~user 50 3~ ~a~c~ ~h~ 1 ~n~th ~ m~n.~ion o~ the balloon 18, either continuously or in a series o~ discrete steps, each with a predetermined dwell time, as the radiant energy source connected to the proximal end connector 62 o~ the assembly o~ Figure 1 transmits the energy down the quartz ~iber 44.
At the same time, a roller pump coupled to a bag o~ normal saline (neither shown) can be made to in~use the lumen 16 o~ the catheter, via the ~lush port 36, to establish a ~ ~096l32986 CA 022l866l l997-l0-20 PCT~S96/05287 positive flow in the distal direction, preventing ingress or blood which might otherwise inter~ere with the transmission o~ W light or other radiant energy ~rom the dif~user to the wall or the artery being treated. Also, by controlling the pressure o~ fluid at the inflation port 34, the balloon can be periodically inflated and deflated during the procedure so that an adequate blood supply is provided distal of the treatment site to nourish the heart muscle. In ~act, the energization of the radiation source, the displacement o~ the optical ~iber and the inflation/de~lation o~ the balloon can be appropriately synchronized.
By positioning the adjustable stop member 56 on the stainless steel sleeve 5~ surrounding the light fiber assem.bly, a limit is established, preventing the distal end of the light fiber from exiting the distal end o~ the catheter. By providing a radiopaque plug 52 in the distal end of the jacket extension, the position o~ the dif~user 50 relative to the radiopaque mar~ers 26 and 28 assists the cardiologist in following the progress o~ the radiant energy treatment o~ the blood vessel wall.
This invention has been described herein in considerable detail in order to comply with the Patent Statutes and to provide those skilled in the art with the in~ormation needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically di~ferent equipment and devices, and that various modi~ications, both 3~ as to th~ ~l;pment details an operating procedures, ca~
be accomplished without departing ~rom the scope o~ the invention itsel~.
What is claimed is:
TISSUE FO~LOWING ANGIOPLASTY TO MINIMIZE RESTENOSIS
BACKGROUND OF THE INVENTION
I. Field of the I~vention: This invention relates generally to surgical instruments ~or improving the outcome o~ percutaneous translllm; n~ 1 coronary angioplasty procedures, and more particularly to a catheter having a means ~or irradiating a treatment site with radiant energy, e.g., W light, to reduce the incidences of restenosis.
-- 10II. Discussion of the Pr;or ~t: Percutaneous transll~min~l coronary angioplasty (PTCA) has become a recognized method o~ reducing the occlusion o~ blood ~ ~ vessels due to coronary artery disease. The procedure involves routing a catheter having an in~latable balloon at the distal end thereo~ through the vascular system until the balloon is positioned at the site o~ the stenotic lesion to be treated. The balloon is then in~lated to compress the atherosclerotic plaque into the wall o~ the coronary artery, thus increasing the size of the opening and enhancing blood ~low through the a~ected artery.
Approximately 400,000 angioplasty procedures are per~ormed annually in the United States to open blocked coronary arteries. However, this success~ul procedure is overshadowed by the occurrence o~ restenosis, a re---25 narrowing o~ the artery. Studies have shown that 30-~0 :percent o~ angioplasty patients experience restenosis -within six months of the angioplasty procedure. When restenosis occurs, patients may be treated with cardiovascular medications, additional angioplasty 30proc~ ~r .b ~ a55 5urg~ry, S~arrying out the angio~?lasty procedure results in damage to the endothelium and it is ~ound that the body~s natural response to such damage is a proli~eration o~ smooth muscle cells, o~tentimes resulting in restenosis.
35In U.S. Patent 5,053,033 to Richard H. Clarke, a technique is described ~or reducing incidences o~
: restenosis ~ollowing angioplasty. The patent describes a :
W~6/32986 CA 022l866l l997-l0-20 PCT~S96/05 procedure in which the blood vessel walls at the angioplasty site are irradiated with W light during the course o~ the angioplasty procedure and that the e~ect o~
such irradiation is to reduce proli~eration o~ smooth muscle cells at the site o~ the damage. In accordance with the te~h;ngs o~ the Clarke patent, the W radiation is delivered by means o~ an optical ~iber incorporated into a percutaneous catheter. The W radiation is sent down the optical fiber from a suitable laser or even a source o~
non-coherent W light. It is theorized that ultraviolet light in the 240 nm to 280 nm range, when delivered to the DNA of smooth muscle cells ef~ects cellular replication, thereby inhibiting proli~eration.
In U.S. Patent Re. 34,544 to Spears, there is described a system ~or per~orming angioplasty which also uses light energy typically in the in~rared range. In accordance with that patent, the subject is ~irst injected with a hematoporphyrin which is selectively taken up into the atheromatous plaque. Subsequently, light in the IR
range is made to impinge on the stenotic lesion, resulting in lysis o~ the plaque. A balloon catheter equipped with a ~lexible optical ~iber is used to deliver the light to the source. When the balloon is in~lated, it displaces the otherwise opaque blood allowing transmission o~ the IR
energy through the balloon to the plaque being irradiated.
While research, to date, has been limited, medical scientists have been exploring the use o~ gamma radiation in treating damage to blood vessel walls resulting ~rom angioplasty and/or atherectomy procedures.
3.0 ~either the Sp~ars Reissue Patent 34,544 nor the Clarke Patent 5,053,033 teaches an apparatus ~or providing a uni~orm exposure o~ the intimal and endothelial layers at the site o~ the treated stenosis to radiation, such as W
light, over the entire area o~ the compressed lesion, nor precise control over the exposure time. Moreover, the liquid ~illed, hollow glass tube 24 at the distal end o~
the catheter 12 in the Spears patent would be relatively ~ w~ ~ola.C~ZSO r~ltu~ /u~
~ ; - CA 02218661 1997-10-20 : -3-rigid and thus likely to cause damage to a vessel wall as the catheter carrying this structure is advanced through the vascular system. In the Clarke patent, the balloon 42 is de~lated during the attempted exposure o~ the treated tissue to W light. Hence, blood will surround the optical lens at the distal end o~ the catheter and e~ectively reduce the transmission o~ W light to the tissue to be irradiated, thereby necessitating longer exposure times.
Thus, it can be seen ~rom the ~oregoing a need exists ~or an improved instrument ~or exposing the area o~
compressed lesion to radiant energy in a controlled manner ~ollowing balloon angioplasty so as to reduce the tendency toward smooth muscle growth and restenosis. It is a principal purpose o~ the present invention to satis~y this need.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided an apparatus ~or treating the wall o~ a blood vessel ~ollowing a balloon angioplasty procedure to reduce a subsequent occurrence o~ restenosis. The apparatus comprises a conventional angioplasty catheter o~ the type having a tubular catheter body with a pro~; m~ 1 end, a distal end portion and ~irst and second lumens extending through the tubular body. An in~latable balloon o~ a predetermined length ~;men~ion is disposed proximate the - distal end portion o~ the catheter body and the interior o~
the balloon is in ~luid commlln;cation with the ~irst lumen.
Both the distal end portion o~ the tubular catheter body and the in~latable balloon are ~abricated ~rom a plastic 3~ ~te~i~l ~ha~ is hi~hly t~ncmissive at the waveleng~h o~
the radiant energy being employed.
An elongated; ~lexible, radiant energy-emitting ~iber, having a proximal end and a distal end, is coaxially disposed in the second lumen o~ the balloon catheter and it extends ~rom the proximal end thereo~ into its distal end portion. The radiant energy ~iber is terminated in a radiant energy di~using element whose length ~im~n~ion is W096l32986 CA 022l866l l997-l0-20 PCT~S96/05~7 ,_ ,~
less than the predetermined length dimension o~ the balloon. Furthermore, the radiant energy transmissive ~iber is longitudinally displaceable within the second lumen o~ the angioplasty catheter. A displacement control means is coupled to the pro~; m~ 1 end of the balloon catheter and to the fiber ~or controllably, longitudinally displacing the radiant energy di~using and emitting element along the predetermined length dimension of the balloon such that the radiant energy, typically W light in the 240 to 280 nm wavelength range, or perhaps gamma radiation, transmitted through the distal end portion of the tubular catheter body and through the balloon material can be made to bathe the site of the compressed lesion in a series of controlled steps as the balloon is periodically in~lated and deflated so as to provide ade~uate blood supply to tissues downstream of the site being treated. By so moving the radiant energy diffusing member within the con~ines o~ the balloon, the irradiated tissue is not subjected to excessive temperature rises.
In accordance with a pre~erred embodiment o~ the invention, the controlled longitudinal displacement o~ the radiant energy di~using element along the length ~;m~n~ion o~ the balloon is achieved using a microprocessor controlled stepping motor connected in driving relationship with a lead screw which, when rotated, is e~ective to translate the optical fiber within the second lumen of the balloon catheter.
DESCRIPTION OF THE DRAWINGS
Further ~eatures and objects o~ the invention will become ~pr~nt to t~nse s~;l led in the art ~rom the ~ol~cw~ng de~ailed description of a preferred er..bodlr.ent, especially when considered in conjunction with the accompanying drawings in which like numerals in the several views re~er to corresponding parts.
Figure 1 is a partially cross-sectioned view o~ the surgical instrument in accordance with the present invention;
W~ ~ol~ZY~ r~llu~Y~>lu~
: ~ ' CA 02218661 1997-10-20 Figure 2 is a cross-sectional view taken along the line 2-2 in Figure 1; and Figure 3 is a side-elevation o~ a device ~or controlling the displacement o~ a radiant energy di~using element located within the distal end portion o~ the catheter.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Re~erring first to Figure 1, there is identi~ied generally by numeral 10 an instrument especially designed ~or delivering radiant energy to a site within the vascular system ~ollowing a balloon angioplasty procedure on a patient. It is seen to comprise an elongated, ~lexible tubular catheter body 12 having an outer diameter o~ about 0.040 in. and a wall thickness o~ approximately .005 in.
The catheter body is pre~erably extruded ~rom polyethylene plastic and, as is illustrated in the cross-sectional view o~ Figure 2, has at least ~irst and second lumens 14 and 16, respectively.
Appropriately bonded to the exterior sur~ace o~ the tubular body 12 at the distal end portion thereo~ is an in~latable expander member or balloon 18, which is circum~erentially bonded at its ends 20 and 22 to the tube 12 at spaced apart locations. In accordance with the present invention, the expander member 18 is also pre~erably ~ormed ~rom polyethylene, a plastic exhibiting - ~high radiant energy transmissivity in the W light portion o~ the spectrum. The expander member 18 may typically be anywhere ~rom 20 to 30 mm in length and it spans one or more ports 24 ~ormed through the wall o~ the catheter body 30 12 ~ r~mml-n~ r~t;n~ ~i~h thr~ ~irst lumen ~4 ~Figure 2), i.e., the in~1ation lumen. It is also ~ound expedient to locate radiopaque marker bands 26 and 28 on opposite ends o~ the expander member to ~acilitate the positioning o~ the expander member relative to a lesion to be treated under 3S ~1uoroscopy.
Disposed at the proximal end o~ the catheter body 12 is a molded plastic hub member 30 which is generally wog6/32s86 CA 02218661 1997-10-20 PCT~S96/05287 tubular and which has a Touchy-Borst type compression fitting 32 disposed near its proximal end. The hub 30 also includes first and second ports 34 and 36 having Luer fitting for connection to liquid supply tubes (not shown).
The port 34 is in fluid communication with the inflation lumen 14 and when a fluid, such as normal saline, is injected under pressure into that port, it ~lows through the lumen 14 and the ports 24 in the catheter to effect in~1ation of the expander member 18. The port 36 is in fluid communication with the lumen 16 which extends all the way to the distal end 38 of the balloon catheter. By pumping saline with a roller pump at a low rate of about 2-4 cubic cms per minute into the port 36, the flow prevents blood from entering the distal end 38 of the catheter.
Extending through the compression fitting 32, the tubular hub 30 and through the second lumen 16 of the instrument 10 is an elongated, flexible, radiant energy-tr~ m;~sive fiber assembly 40. Where the radiation source to be employed is a source of W light, the radiant energy 20 tr~n.~ sive fiber may comprise a core member 42 including a quartz fiber 44 covered by a Teflon jacket 46. The wall thickness of the jacket may be approximately 0.003 in. The quartz fiber has a distal end 48 and the jacket 46 extends in the distal direction beyond the end 48 of the fiber ~or 25 a distance of about 6 mm and forms a radiant energy di~fusing and emitting element 50. A radiopaque plug 52 is fitted into the distal end of the element 50.
Starting a predetermined distance proximal of the distal plug 52 and extending proximally through the 3~ c~m~ressi~n fi~ting 32 of the hub 30 is an outer tllh-reinforcing member 54, which preferably comprises a stainless steel tube whose O.D. is about 0. 014 in. The stainless steel reinforcing member 54 tightly surrounds the jacket 46 of the quartz fiber 44 and because of its relative rigidity compared to that o~ the quartz fiber 44, it permits the radiant energy transmissive fiber assembly 40 to be pushed longitudinally through the lumen 16 o~ the W ~ 96/32986 PCT/US96/0~287 : -7-catheter body 12 when a ~orce is applied at the proximal end o~ the radiant energy transmissive ~iber assembly. The length of the core 42 that extends beyond the distal terminus o~ the reinforcing member 54 may be approximately 13 in. and, as such, the assembly 40 exhibits su~ficient "pushability" and "torqueability" to permit the unrein~orced portion to traverse the lumen 16 o~ the tubular body 12. I~ gamma radiation is to be delivered to the a~fected area o~ the blood vessel, a suitable source o~
gamma radiation, such as cobalt 60 particles may be embedded in the plastic at the distal end o~ an elongated ~lexible ~iber.
With continued re~erence to Figure 1, there is shown attached to the portion o~ the radiant energy-transmissive ~iber assembly 40 extending proximally beyond the compression ~itting 32 an adjustable stop member 56. The stop member 56 can be moved longitudinally along the ~iber assembly 40 to a desired position and then locked in place by rotating the knurled grip 58, thereby e~ectively establishing a predetermined travel distance between the stop member 56 and the proximal end o~ the hub 30. This also de~ines the extent o~ displacement o~ the di~using element 50 in the distal direct-ion.
The radiant energy-transmissive ~iber assembly 40 extends proximally beyond the stop member 56 and passes through a strain relie~ member 60, terminating in a standard connector 62. Connector 62 is adapted to couple with the output o~ a radiant energy source (not shown).
The radiant energy source is pre~erably a pulsed or 3~ contin~ c ~av~ l~c~ ~p~hl~ ~ producing an O-lt~t beam at an appropriate W wavelength. It has been ~ound that a wavelength in the range o~ ~rom 240 nm to 280 nm covers the range exhibiting e~icacy in inhibiting smooth muscle tissue growth.
The W light emanating ~rom the laser source passes through the quartz ~iber 44 to its distal end 48. The Te~lon di~using element 50, comprising the jacket W096/32986 CA 022l866l l997-l0-20 PCT~S96/OS287 extension, is found to uniformly diffuse the W light exiting the end o~ the quartz fiber. Because the tu~ular body 12 and the expander member 18 are fabricated from a highly W light transmissive material (polyethylene), the W light emanating ~rom the di~user 50 causes a radial band o~ light, approximately the length of the jacket extension, to radiate out through the expander member to impinge upon the intimal tissue. By controlling the displacement of the ~iber in the axial direction, the emanating band o~ W radiation can be made to traverse the ;: entire length of the expander member continuously or in discrete steps to thereby expose the adjacent vessel wall to the radiant energy. It is possible, of course, to also rotate the radiant energy transmissive fiber assembly 40 within the lumen of the catheter when and if the radiation pattern exiting the diffusing member is not annularly symmetrical.
Referring next to Figure 3, there is shown an apparatus ~or controlling the movement of the radiant energy-transmissive ~iber assembly 40 within the lumen 16 of the instrument 10. The apparatus comprises a stationary clamping member 70 having a longitudinal slot 72 formed therein for receiving the tubular barrel of the hub 30. A
: slide plate 74, when retracted, permits the tubular barrel to be inserted in the slot 72 and when again extended, securely clamps the hub member against longitll~;n~l displacement. The stationary clamping member 70 is affixed to the distal end o~ a guide member 76 which passes through a slot ~ormed in a movable clamping member 78. The movable cl~mr;ng member is designed to engage the adjustable stop 56 so that when the movable clamping member 78 is displaced in the direction of the double-headed arrow 80 along the guide 76, the elongated, flexible, light transmissive fiber assembly 40 is likewise translated.
To controllingly displace the moveable clamping member 78, there is provided a stepper motor 82 which is mounted on a base 84 and which is connected in driving relationship WO9~/32986 CA 02218661 1997-10-20 PCT~S96105287 _ g_ to a threaded lead screw 86 supported at its ~ree end in a bearing 88 mounted on a rectangular post 90, also secured to the base 84. The lead screw 86 passes through a threaded bore 92 formed through a rectangular nut 94. The nut is constrained against rotation by a suitable means, such as a Nylon slide bearing 96 that is a~ixed to the nut 94 and which slidingly cooperates with a sur~ace o~ the base 84. An elongated segment o~ piano wire 98 is connected between the traveling nut 94 and the moveable -. 10 clamping member 78. More particularly, the piano wire 98 passes through a bore 100 ~ormed through a block 102 a~ixed to the post 90. A tubular sheath 104 surrounds the piano wire between the block 102 and a wire guide 106 ~ormed as a part o~ the guide member 76. The piano wire 98 is then secured to the moveable clamping member 78 as illustrated.
An electronics module 108 is connected to the motor and contains a microprocessor chip and associated memory ~or storing a program o~ instructions controlling the operation o~ the stepper motor 82. The microprocessor is programmed to supply stepping pulses at a predetermined rate to the motor 82 with each pulse producing a rotation of the lead screw through a predetermined arc and a corresponding translational displacement o~ the nut 92 and, there~ore, the axial disposition o~ the optical ~iber ~ assembly 40 within the lumen 16 o~ the i~strument. The microprocessor is programmed in a known manner to cause the stepper motor to drive the lead screw in accordance with a predetermined time pro~ile, such that the di~user 50 3~ ~a~c~ ~h~ 1 ~n~th ~ m~n.~ion o~ the balloon 18, either continuously or in a series o~ discrete steps, each with a predetermined dwell time, as the radiant energy source connected to the proximal end connector 62 o~ the assembly o~ Figure 1 transmits the energy down the quartz ~iber 44.
At the same time, a roller pump coupled to a bag o~ normal saline (neither shown) can be made to in~use the lumen 16 o~ the catheter, via the ~lush port 36, to establish a ~ ~096l32986 CA 022l866l l997-l0-20 PCT~S96/05287 positive flow in the distal direction, preventing ingress or blood which might otherwise inter~ere with the transmission o~ W light or other radiant energy ~rom the dif~user to the wall or the artery being treated. Also, by controlling the pressure o~ fluid at the inflation port 34, the balloon can be periodically inflated and deflated during the procedure so that an adequate blood supply is provided distal of the treatment site to nourish the heart muscle. In ~act, the energization of the radiation source, the displacement o~ the optical ~iber and the inflation/de~lation o~ the balloon can be appropriately synchronized.
By positioning the adjustable stop member 56 on the stainless steel sleeve 5~ surrounding the light fiber assem.bly, a limit is established, preventing the distal end of the light fiber from exiting the distal end o~ the catheter. By providing a radiopaque plug 52 in the distal end of the jacket extension, the position o~ the dif~user 50 relative to the radiopaque mar~ers 26 and 28 assists the cardiologist in following the progress o~ the radiant energy treatment o~ the blood vessel wall.
This invention has been described herein in considerable detail in order to comply with the Patent Statutes and to provide those skilled in the art with the in~ormation needed to apply the novel principles and to construct and use such specialized components as are required. However, it is to be understood that the invention can be carried out by specifically di~ferent equipment and devices, and that various modi~ications, both 3~ as to th~ ~l;pment details an operating procedures, ca~
be accomplished without departing ~rom the scope o~ the invention itsel~.
What is claimed is:
Claims (18)
1. Apparatus for treating the wall of a lumen of a tubular vessel to modify the tissue for therapeutic benefit comprising, in combination:
(a) a catheter having an elongated, flexible tubular catheter body with a proximal end, a distal end portion, first and second lumens extending through the tubular body and an inflatable balloon of a predetermined length dimension disposed proximate the distal end portion of the tubular catheter body and in fluid communication with the first lumen, both the distal end portion of the tubular catheter body and the inflatable balloon being made from a UV light transmissive material;
(b) an elongated, flexible, UV light emitting fiber having a proximal end and a distal end, the UV light emitting fiber being coaxially disposed in the second lumen and extending from the proximal end of the tubular catheter body to the distal end portion, the UV light emitting fiber being displaceable longitudinally within the second lumen;
(c) means for supplying the UV light emitting fiber from a source of UV light of a selected wavelength and energy insufficient to effect tissue necrosis; and (d) means coupled to the proximal end of the catheter body and to the UV light emitting fiber for controllably longitudinally displacing the distal end of the UV light emitting fiber along the predetermined length dimension of the balloon to expose a wall surface of the lumen of the tubular vessel to UV light.
(a) a catheter having an elongated, flexible tubular catheter body with a proximal end, a distal end portion, first and second lumens extending through the tubular body and an inflatable balloon of a predetermined length dimension disposed proximate the distal end portion of the tubular catheter body and in fluid communication with the first lumen, both the distal end portion of the tubular catheter body and the inflatable balloon being made from a UV light transmissive material;
(b) an elongated, flexible, UV light emitting fiber having a proximal end and a distal end, the UV light emitting fiber being coaxially disposed in the second lumen and extending from the proximal end of the tubular catheter body to the distal end portion, the UV light emitting fiber being displaceable longitudinally within the second lumen;
(c) means for supplying the UV light emitting fiber from a source of UV light of a selected wavelength and energy insufficient to effect tissue necrosis; and (d) means coupled to the proximal end of the catheter body and to the UV light emitting fiber for controllably longitudinally displacing the distal end of the UV light emitting fiber along the predetermined length dimension of the balloon to expose a wall surface of the lumen of the tubular vessel to UV light.
2. The apparatus as in Claim 1 wherein the UV light emitting fiber includes a UV light diffusing element at a distal end thereof.
3. The apparatus as in Claim 2 wherein the UV light emitting fiber includes:
(a) an elongated, flexible quartz fiber core having a polytetrafluoroethylene jacket thereon, the jacket having a segment extending beyond a distal end of the core, the segment comprising the UV light diffusing element.
(a) an elongated, flexible quartz fiber core having a polytetrafluoroethylene jacket thereon, the jacket having a segment extending beyond a distal end of the core, the segment comprising the UV light diffusing element.
4. The apparatus as in claim 1 wherein said source of UV light produces UV radiation whose wavelength is in the range of from 240 nm to 280 nm.
5. The apparatus as in Claim 3 and further including a radiopaque plug disposed in a distal end of the extending segment of the jacket.
6. The apparatus as in any one of Claims 3 or 4 and further including a reinforcing tubular member coaxially disposed about the jacket and extending from the proximal end of the UV light emitting fiber toward, but short of, the distal end of the UV light transmissive fiber by a predetermined length dimension greater than the predetermined length dimension of the diffusing element.
7. The apparatus as in Claim 5 and further including a tubular hub member affixed to the proximal end of the tubular catheter body, the tubular hub member having a first port in fluid communication with the first lumen and a second port in fluid communication with the second lumen.
8. The apparatus as in Claim 7 and further including a third port on the hub member leading to the second lumen, the third port including a compression fitting for clamping engagement with the reinforcing tube member.
9. The apparatus as in Claim 8 and further including a stop member coaxially surrounding the reinforcing tube member at a location proximal to the compression fitting, the stop member establishing a maximum displacement of the UV light emitting fiber in a distal direction within the second lumen.
10. The apparatus as in Claim 1 wherein the means coupled to the proximal end of the tubular catheter body and to the UV light emitting fiber for controllably longitudinally displacing the UV light diffusing element comprises a stepping motor.
11. The apparatus as in Claim 10 and further including a slide block connected to the UV light emitting fiber and a stationary block connected to the proximal end of the tubular catheter body, the stepping motor being operatively coupled to the slide block.
12. The apparatus as in Claim 11 wherein the stepping motor is operatively coupled to the slide block by a lead screw, the lead screw including a traveling nut, and means coupling the traveling nut to the slide block.
13. The apparatus as in Claim 10 and further including a microprocessor-based controller coupled in controlling relation to said stepping motor for furnishing drive pulses thereto in accordance with a predetermined program.
14. The apparatus as in Claim 1 wherein the inflatable balloon is an oriented polyethylene film.
15. The apparatus as in Claim 14 wherein the distal end portion of the tubular catheter body is made of polyethylene.
16. A method for treating the wall of a lumen of a tubular vessel to modify the tissue for therapeutic benefit comprising the steps of:
(a) introducing into the tubular vessel a catheter having an elongated flexible tubular body with an inflatable balloon attached thereto at a distal end thereof and first and second lumens extending the length of the flexible tubular body, one of the first and second lumens being in fluid communication with the inflatable balloon, the inflatable balloon and the portion of the tubular body to which the balloon is attached being made of a UV light transmissive material, the other of the first and second lumens containing an elongated, flexible UV light transmissive fiber with a radiant energy emitting surface at a distal end thereof;
(b) connecting a proximal end of the UV light transmissive fiber to a source of UV light of a predetermined wavelength;
(c) inflating the balloon with a UV light transmissive fluid to displace blood away from the tissue to be modified;
(d) longitudinally displacing the optical fiber within the second lumen such that UV light emitted from said surface is made to scan the wall of the lumen of the tubular vessel being treated in accordance with a predetermined exposure profile.
(a) introducing into the tubular vessel a catheter having an elongated flexible tubular body with an inflatable balloon attached thereto at a distal end thereof and first and second lumens extending the length of the flexible tubular body, one of the first and second lumens being in fluid communication with the inflatable balloon, the inflatable balloon and the portion of the tubular body to which the balloon is attached being made of a UV light transmissive material, the other of the first and second lumens containing an elongated, flexible UV light transmissive fiber with a radiant energy emitting surface at a distal end thereof;
(b) connecting a proximal end of the UV light transmissive fiber to a source of UV light of a predetermined wavelength;
(c) inflating the balloon with a UV light transmissive fluid to displace blood away from the tissue to be modified;
(d) longitudinally displacing the optical fiber within the second lumen such that UV light emitted from said surface is made to scan the wall of the lumen of the tubular vessel being treated in accordance with a predetermined exposure profile.
17. The method as in Claim 16 and further including the step of periodically deflating the balloon at predetermined intervals to permit blood flow distal of the inflatable balloon.
18. The method as in either of Claims 16 and 17 wherein the source of UV light provides UV light whose wavelength is in the range of from 240 nm to 280 nm.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US08/425,858 US5620438A (en) | 1995-04-20 | 1995-04-20 | Method and apparatus for treating vascular tissue following angioplasty to minimize restenosis |
US08/425,858 | 1995-04-20 |
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CA2218661A1 true CA2218661A1 (en) | 1996-10-24 |
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CA002218661A Abandoned CA2218661A1 (en) | 1995-04-20 | 1996-04-17 | Method and apparatus for treating vascular tissue following angioplasty to minimize restenosis |
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EP (1) | EP0830178A4 (en) |
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-
1995
- 1995-04-20 US US08/425,858 patent/US5620438A/en not_active Expired - Fee Related
-
1996
- 1996-04-17 AU AU55513/96A patent/AU698703B2/en not_active Ceased
- 1996-04-17 JP JP8531869A patent/JPH11511673A/en active Pending
- 1996-04-17 WO PCT/US1996/005287 patent/WO1996032986A1/en not_active Application Discontinuation
- 1996-04-17 EP EP96912828A patent/EP0830178A4/en not_active Withdrawn
- 1996-04-17 CA CA002218661A patent/CA2218661A1/en not_active Abandoned
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EP0830178A4 (en) | 2001-04-18 |
AU698703B2 (en) | 1998-11-05 |
AU5551396A (en) | 1996-11-07 |
US5620438A (en) | 1997-04-15 |
WO1996032986A1 (en) | 1996-10-24 |
EP0830178A1 (en) | 1998-03-25 |
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Legal Events
Date | Code | Title | Description |
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EEER | Examination request | ||
FZDE | Discontinued |