CA2139536C - Biopsy needle - Google Patents
Biopsy needleInfo
- Publication number
- CA2139536C CA2139536C CA002139536A CA2139536A CA2139536C CA 2139536 C CA2139536 C CA 2139536C CA 002139536 A CA002139536 A CA 002139536A CA 2139536 A CA2139536 A CA 2139536A CA 2139536 C CA2139536 C CA 2139536C
- Authority
- CA
- Canada
- Prior art keywords
- stylet
- distal
- recess
- bottom wall
- biopsy needle
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
- A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
Abstract
A stylet for a biopsy needle is provided with a specimen recess inwardly of the distal end thereof which has a bottom wall parallel to the axis of the stylet and distal and proximal end walls which are reentrant relative to the distal end and proximal position of the stylet, respectively.
Description
CA21 3q536 _ BIOPSY NRRnT.R
R~k~round of the Invention This invention relates in general to 6urgical needles and, more particularly, to improvements in a biopsy needle and a biopsy needle stylet which optimize cutting and with-drawal of tissue specimens during a biopsy procedure.
A biopsy needle of the character to which the present invention relates is a side cut needle such as that dis-closed in patent 3,477,423 to Griffith. Such a side cut needle includes a solid stylet telescopically received with-in an inner tubular cutting cannula which in turn is tele-scopically received within an outer tubular cannula in which the stylet and inner cannula are supported for axial and rotative displacement relative to one another and to the outer cannula. The stylet is provided with a specimen cut-ting recess, or tissue receptacle, in the distal portion thereof by which a tissue specimen severed at the biopsy site is removable therefrom. More particularly, the side cut needle is inserted into a patient until the distal end of the outer cannula reaches the lesion where the biopsy specimen is to be taken, and the stylet is then advanced relative to the outer and inner cannulas into the lesion to the biopsy site. The ti~sue at the site moves into the specimen recess, and the inner cannula is then advanced rel-ative to the outer cannula and over the stylet to cut the tissue into the specimen recess and to cover the recess and thus entrap the specimen therein for removal from the site.
Such removal is achieved by retracting the stylet and inner cutting cannula into the outer cannula and then withdrawing the needle from the patient.
Heretofore, the cutting recess in the stylet component of a biopsy needle has been defined by an axially extending bottom wall parallel to the axis of the stylet and A~; ~11y spaced apart end walls perpendicular to the bottom wall and thus the stylet axis. When the stylet is advanced into the area from which tissue is to be removed, the tissue enters the recess as the stylet advances therethrough and the ~' ('A2 1 3~536 tissue i8 ~evered and captured in the recess by advancement of the inner cutting cannula relative to the stylet. With a recess of the foregoing structure, it is difficult to obtain a desirable quantity of specimen tissue in the cutting re-cess and, in this respect, it is not uncommon to withdraw a specimen which, from the standpoint of quantity, is only one-half to three-quarters the quantity which would be re-moved if the cutting recess were completely filled. This deficiency i8 due at least in part to the difficulty in maintAin;ng stability with respect to the position of the stylet at the biopsy site during advancement of the cutting cannula relative thereto. When the component parts of the biopsy needle are manually manipulated, for example, there is a tendency to advance and/or withdraw the stylet from its initial position at the biopsy site during advancement of the cutting cannula. Both of these movements cause a por-tion of the specimen initially received in the cutting re-cess to be displaced therefrom whereby, when severing is completed by advancement of the cutting cannula, the quanti-ty of tissue captured in the recess is less than that which is possible based on the size of the recess. As another example, biopsy needles of the foregoing structure are often operated through the use of a "gun" by which displacement of the component parts of the needle is automated during the biopsy procedure, and there is a recoil action in connection with such automated guns which tends to push the stylet for-wardly from its initial position at the biopsy site during advancement of the cutting cannula. As mentioned above, such advancement of the stylet further into the tissue at the biopsy site causes a portion of the tissue in the cut-ting recess to be displaced therefrom.
It is believed that the tissue loss encountered with a stylet structured and operated as referred to above is the result of the perpendicular disposition of the end walls of the recess relative to the bottom wall thereof. In this respect, as the stylet is advanced or withdrawn relative to the tissue site during advancement of the cutting cannula, the end walls at the opposite ends of the rece~s move against the tissue specimen and the perpendicular CA2 1 3~536 disposition of the walls tends to deflect the tissue later-ally outwardly of the recess. Thus, the quantity of tissue which is captured in the recess upon completing the advance-ment of the cutting c~nnllla is reduced relative to the opti-mum capability of the recess.
Summary of the Invention The present invention provides improvements in the con-struction of the stylet of a biopsy needle by which the foregoing problems are overcome. More particularly in this respect, the recess of a stylet in accordance with the present invention has a bottom wall parallel to the axi~ of the stylet and distal and proximal end walls between the bottom wall and the outer surface of the stylet which pro-vide the recess with an entrance end radially spaced from the bottom wall and an inner portion which is axially en-larged relative to the entrance end. This configuration of the recess is achieved by providing for at least one of the distal and proximal end walls, and preferably both, to be reentrant from the entrance end of the recess with respect to the corresponding one of the distal and proximal portions of the stylet, whereby the recess has a portion rA~ y inwardly of the entrance end which has an axial dimension greater than the axial dimension of the entrance end.
With respect to the quantity of specimen tissue which can be captured and removed from a biopsy site with a biopsy needle having a stylet according to the present invention, the reentrant disposition of each of the distal and prox;~-l end walls of the recess provides independent advantages in conjunction with the biopsy procedure and an optimum advan-tage with regard to the procedure when both end walls are reentrant. With regard to the reentrant disposition of the distal end wall of the recess, the latter provides a notch at the distal end of the recess which functions to secure the stylet in the tissue against withdrawal of the stylet while the cutting c~nnltl~ is advanced forward to complete the cutting and capturing of the specimen in the stylet re-cess. Furthermore, the rA~;~lly outer edge of the end wall is generally of elliptical contour and not in a plane per-pendicular to the stylet axis, and thus enhance cutting of ,~
5 3 ~
-the tissue specimen by rotation of the stylet prior to ad-vancement of the cutting cannula. The reentrant disposition of the proximal end wall of the recess provides a notch which functions to secure the stylet in the tissue against S advancement further into the biopsy site from the initial position during advancement of the cutting cannula to com-plete the cutting and capturing operation. Further, as with the distal end wall, the proximal end wall has an outer edge which can e~h~nce cutting of the tissue specimen.
The notches provided by the reentrant dispositions of the distal and proximal end walls of the recess provide the ~urther advantage of holding the tissue specimen firmly against the cutting recess and against lateral separation therefrom, thus to enhAnc~ cutting of the tissue when the cutting cannula is advanced and to optimize the quantity of tissue which is captured and removed from the biopsy site.
In this respect, the notch at the proximal end of the recess is driven into the tissue and the reentrant disposition of the proximal end wall pushes the tissue radially inwardly of the recess and into the corner between the proximal end wall and bottom wall of the recess and thus holds the tissue against separation from the recess. The notch at the distal end of the recess e~hAnces filling the axial length of the recess with tissue during the biopsy process in that the reentrant disposition of the distal end wall of the recess also serves to capture tissue in the notch provided thereby thus to hold the tissue against displacement radially out-wardly of the recess during advancement of the cutting cannula.
It is accordingly an out~tAn~ing object of the present invention to provide a biopsy needle stylet with an improved cutting recess structure.
Another object is the provision of a stylet of the foregoing character in which the cutting recess promotes securing the stylet in the tissue at a biopsy site against axial displacement relative thereto during a biopsy proce-dure.
.~
213~536 ' X-9336 ~_ A further object i8 the provision of a stylet of the foregoing character which optimizes the quantity of tissue which can be removed from the biopsy site during the biopsy procedure.
Yet another object i8 the provision of a stylet of the foregoing character wherein the cutting recess is structured to hold the tissue in place relative to the recess during advancement of a cutting cannula relative thereto to cut and capture the specimen in the recess.
Still a further object i8 the provision of a stylet of foregoing character in which the cutting recess includes distal and proximal end walls which are reentrant with re-spect to the distal and proximal portions of the stylet, respectively.
Still another object is the provision of a biopsy nee-dle including an improved stylet of the foregoing character.
Brief Description of the Drawings The foregoing objects,-and others, will in part be ob-vious and in part pointed out more fully hereinafter in con-junction with the written description of preferred embodi-ments of the invention illustrated in the accompanying draw-ings in which:
FIGURE 1 is an elevation view, partially in section, of a prior art biopsy needle stylet;
FIGURE 2 is a cross-sectional elevation view of the stylet taken along line 2-2 in FIGURE l;
FIGURE 3 is a side elevation view, partially in sec-tion, of a biopsy needle stylet in accordance with the present invention;
FIGURE 4 is a cross-sectional elevation view of the stylet in FIGURE 3 taken along line 4-4 therein;
FIGURE 5 is a sectional side elevation view showing the outer cannula, cutting cannula and stylet of a biopsy needle in accordance with the present invention in assembled rela-tionship prior to use of the needle;
FIGURES 6 and 7 are side elevation views, partially in section, showing the various positions of the component parts of the needle as a biopsy specimen is taken; and 213~5~6 X-9336 ~_ FIGURE 8 is a side elevation view, partially in sec-tion, of another embodiment of a biopsy needle stylet in accordance with the present invention.
Description of Preferred Embodiment~
Referring now in greater detail to the drawings, where-in the showings are for the purpose of illustrating pre-ferred embodiments of the invention only and not for the purpose of limiting the invention, FIGURES 1 and 2 illu8-trate a prior art biopsy needle stylet 10 which is solid and circular in cross-section having an axis A and a diameter which, as is well known, provides for the stylet to be slid-ably and rotatably received in a tubular inner or cutting cannula of a biopsy needle. Stylet 10 includes a distal portion 12 and a proximal portion 14 extending axially in-wardly therefrom, and the ~x;~lly outer end of distal por-tion 12 is beveled to provide a distal tip or end 16. The stylet is radially and axially cut away at a location be-tween distal end 16 and proximal portion 14 to provide a specimen receiving recess 18 and a solid portion 20 sp~nning the recess. Recess 18 includes a bottom wall 22 parallel to axis A and having axially extending laterally opposite edge~
24 which provide cutting edges for severing a specimen at the biopsy site if the stylet is rotated. Recess 18 further includes a distal end wall 26 and a proximal end wall 28, each of which extends perpendicular to bottom wall 22 and between the bottom wall and outer surface 30 of the stylet.
FIGURES 3 and 4 illustrate a modification of the recess in a stylet of the foregoing character to provide a stylet lOA in accordance with the present invention. With the ex-ception of the recess, stylet lOA corresponds to stylet 10 described above, whereby like numerals are used in FIGURES 3 and 4 to designate corresponding parts of the stylet. Re-ferring to the latter figures, stylet lOA is provided with a recess 32 having an ~x;~lly extending bottom wall 34 paral-lel to axis A and providing axially extending laterally op-posite edges 36 corresponding to edges 24 of stylet 10 in 2 1 3 'J ~ ~ b X-9336 i~ FIGURES 1 and 2. Recess 32 includes a distal end wall 38 and a proximal end wall 40, each of which extends between bottom wall 34 and outer surface 30 of the stylet and each of which, is reentrant with respect to the corresponding one of the distal and proximal portions 12 and 14 of the stylet.
The reentrant disposition of walls 38 and 40 provides for recess 32 to have an entrance end radially spaced from bot-tom wall 34 and having an axial dimension L1, and a portion rA~ially inwardly of the entrance end and having a major axial dimension L2 which is greater than dimension L1. In the ~o~;~ent illustrated in FIGURES 3 and 4, wall~ 38 and 40 are planar, and the reentrant disposition thereof is pro-vided by inclining each of the walls at an acute angle a relative to bottom wall 34. Angle a i5 between 15~and 85~
and, preferable is about 45~. Wall 38 has a radially outer edge 38a which is elliptical in contour when viewed perpen-dicular to bottom wall 34, and wall 40 ha~ a radially outer edge 40a of the same contour. Edges 38a and 40a intersect an axial plane perpendicular to bottom wall 34 at points 38b and 40b, respectively, to provide dimension L1 for the en-trance end of the recess. Further, while the intersections between walls 38 and 40 and the corresponding end of bottom wall 34 are shown as being rounded, it will be appreciated that such intersections could be defined by sharp corners or by rounded corners of larger radius than shown.
Referring now to FIGURE 5 of the drawing, stylet lOA is ~hown in assembled relationship with a tubular inner cutting cannula 42 and a tubular outer cannula 44 to provide a biop-sy needle in which the stylet and cannulas are coaxial and supported for relative axial and rotational displacement relative to one another. Inner cutting cannula 42 ha~ a distal portion 46 including tapered distal cutting edge 48 which includes a cutting tip 50 at the distal end of the cutting cannula, and outer cannula 44 ha~ a distal portion 52 including a tapered distal end 54. Inner cannula 42 has a proximal portion 56 and outer cannula 44 has a proxLmal portion 58 and, while not illustrated, it will be appre-ciated that the proximal ends of the cannulas and stylet have handles or the like to facilitate manual manipulation CA2 ~ 3~536 of the needle parts relative to one another. Alternatively, the proximal ends have the necessary connections for inter-engaging the needle parts with a gun by which the operation of the needle is automated.
When assembled, cutting cannula 42 and stylet lOA are displaceable between retracted and extended positions rela-tive to outer cannula 44 and, prior to use, are in the re-tracted positions thereof shown in FIGURE 5. In use, with the inner cannula and stylet in the retracted positions thereof, the needle is inserted into the body of a patient until the distal ends of the component parts of the needle are adjacent a lesion 60 from which a biopsy specimen is to be taken, as shown in FIGURE 5. When so positioned, stylet lOA is displaced axially outwardly relative to the outer and inner cannulas from its retracted position to its extended position in which specimen recess 32 is located at the biop-sy site in lesion 60 as shown in FIGURE 6. As will be ap-preciated from the latter Figure, the reentrant notched con-figuration of end walls 38 and 40 relative to bottom wall 34 of recess 32 stabilizes stylet lOA against axial displace-ment in the lesion and, in response to any such axial dis-placement, the walls engage and bias the adjacent ends of the tissue in the recess inwardly against bottom wall 34.
This advantageously precludes the end portions of the tissue from being displaced outwardly through the entrance into the recess during completion of the specimen cutting operation and which displacement would result in a loss of a quantity of the tissue specimen which would otherwise be captured and removed from the site.
When stylet lOA is located at the biopsy site in lesion 60 as shown in FIGURE 6, the stylet can be rotated about axis A as ; n~i cAted by arrow 62 for one of the edges 36 of bottom wall 34 and edges 38a and 40a of end walls 38 and 40 to sever the tissue at the biopsy site. The reentrant dis-position of end walls 38 and 40 of recess 32 provides the further advantage of e~hAncing cutting of tissue by rotation of stylet lOA relative to the cutting which can be achieved with a stylet in which the end walls of the recess are per-pendicular to the bottom wall thereof. In this respect, the ~
reentrant configuration captures the adjacent end portions of the tissue against~the bottom wall of the recess as de-scribed above, whereby edges 38a and 40a of the end walls are more effective in severing the tissue in response to rotation of the stylet about axis A. In any event, when stylet lOA is at the biopsy site, cutting cannula 42 is dis-placed axially outwardly relative to outer cannula 44 and stylet lOA from its retracted position shown in FIGURE 6 to its extended position shown in FIGURE 7. During such move-ment of cutting cannula 42, cutting edge 48 and tip 50 at the distal end thereof cut the tissue at the biopsy site into recess 32 and, in moving axially across the recess, cannula 42 rA~; Al ly captures a specimen S in recess 32 as shown in FIGURE 7. As mentioned hereinabove, the quantity of specimen captured in recess 32 during movement of cutting cannula 42 to the position shown in FIGURE 7 is optimized by the stabilizing effect against axial displacement of cannula lOA which is provided by the reentrant configuration of re-cess walls 38 and 40. When the tissue specimen S has been captured in recess 32 as described above, stylet lOA and cutting cannula 42 are withdrawn together from the lesion to their retracted positions relative to outer cannula 44, as shown in FIGURE 5, and the needle is then withdrawn from the patient.
FIGURE 8 illustrates another embodiment of a stylet in accordance with the present invention. In this embodiment stylet lOB is identical to stylet lOA described above with the exception of the contour of the end walls of the speci-men recess, whereby like numerals are employed in FIGURE 8 to designate the parts of stylet lOB corresponding to those of stylet lOA. In this embodiment, cutting recess 32 has distal and proximal end walls 64 and 66, respectively, which are reentrant from outer surface 30 of the stylet with re-spect to the corresponding one of the distal and proximal portions 12 and 14 of the stylet. End walls 64 and 66 are of an arcuate contour between bottom wall 34 of the reces~
and outer surface 30 of the stylet and include circum-ferentially extending rA~ ly outer side edges 64a and 66a, respectively. Edges 64a and 66a intersect an axial plane _ g _ 213~5~6 X-9336 _ perpendicular to bottom wall 34 at point~ 64b and 66b, re-spectively, to provide the recess with an entrance end hav-ing an axial dimension Ll. The reentrant disposition of end walls 64 and 66 provides for the recess to have a portion radially inwardly of the entrance end having a major axial dimension L2 which is greater than dimension Ll. As will be appreciated from the description of stylet lOA here;n~hove, the reentrant disposition of end walls 64 and 66 provides for stylet lOB to provide the same functions as end walls 38 and 40 of stylet lOA in connection with use of a biopsy nee-dle including stylet lOB.
While considerable emphasis has been placed herein on the structures of preferred embodiments of the stylets, it will be appreciated that other structures as well as mod-ifications of the disclosed structures can be made without departing from the principles of the invention. In this respect, for example, the end walls of the tissue cutting recess of the stylet can be V-shaped with the apex of the V
parallel to the bottom wall of the recess and located be-tween the bottom wall and outer surface of the stylet. Fur-ther, the reentrant confiqurations of the di~tal and proximal end walls of the recess do not have to be the same and, for example, can include a combination of a planar in-clined wall a~ shown in connection with stylet lOA together with an arcuate wall a~ shown in connection with stylet lOB.
As a further example, the acute angles between the end walls and bottom wall of stylet lOA do not have to be the same.
These and other modifications of the preferred embodiment~
as well as other embodiments of the invention will be obvi-ous and suggested to those skilled in the art, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
R~k~round of the Invention This invention relates in general to 6urgical needles and, more particularly, to improvements in a biopsy needle and a biopsy needle stylet which optimize cutting and with-drawal of tissue specimens during a biopsy procedure.
A biopsy needle of the character to which the present invention relates is a side cut needle such as that dis-closed in patent 3,477,423 to Griffith. Such a side cut needle includes a solid stylet telescopically received with-in an inner tubular cutting cannula which in turn is tele-scopically received within an outer tubular cannula in which the stylet and inner cannula are supported for axial and rotative displacement relative to one another and to the outer cannula. The stylet is provided with a specimen cut-ting recess, or tissue receptacle, in the distal portion thereof by which a tissue specimen severed at the biopsy site is removable therefrom. More particularly, the side cut needle is inserted into a patient until the distal end of the outer cannula reaches the lesion where the biopsy specimen is to be taken, and the stylet is then advanced relative to the outer and inner cannulas into the lesion to the biopsy site. The ti~sue at the site moves into the specimen recess, and the inner cannula is then advanced rel-ative to the outer cannula and over the stylet to cut the tissue into the specimen recess and to cover the recess and thus entrap the specimen therein for removal from the site.
Such removal is achieved by retracting the stylet and inner cutting cannula into the outer cannula and then withdrawing the needle from the patient.
Heretofore, the cutting recess in the stylet component of a biopsy needle has been defined by an axially extending bottom wall parallel to the axis of the stylet and A~; ~11y spaced apart end walls perpendicular to the bottom wall and thus the stylet axis. When the stylet is advanced into the area from which tissue is to be removed, the tissue enters the recess as the stylet advances therethrough and the ~' ('A2 1 3~536 tissue i8 ~evered and captured in the recess by advancement of the inner cutting cannula relative to the stylet. With a recess of the foregoing structure, it is difficult to obtain a desirable quantity of specimen tissue in the cutting re-cess and, in this respect, it is not uncommon to withdraw a specimen which, from the standpoint of quantity, is only one-half to three-quarters the quantity which would be re-moved if the cutting recess were completely filled. This deficiency i8 due at least in part to the difficulty in maintAin;ng stability with respect to the position of the stylet at the biopsy site during advancement of the cutting cannula relative thereto. When the component parts of the biopsy needle are manually manipulated, for example, there is a tendency to advance and/or withdraw the stylet from its initial position at the biopsy site during advancement of the cutting cannula. Both of these movements cause a por-tion of the specimen initially received in the cutting re-cess to be displaced therefrom whereby, when severing is completed by advancement of the cutting cannula, the quanti-ty of tissue captured in the recess is less than that which is possible based on the size of the recess. As another example, biopsy needles of the foregoing structure are often operated through the use of a "gun" by which displacement of the component parts of the needle is automated during the biopsy procedure, and there is a recoil action in connection with such automated guns which tends to push the stylet for-wardly from its initial position at the biopsy site during advancement of the cutting cannula. As mentioned above, such advancement of the stylet further into the tissue at the biopsy site causes a portion of the tissue in the cut-ting recess to be displaced therefrom.
It is believed that the tissue loss encountered with a stylet structured and operated as referred to above is the result of the perpendicular disposition of the end walls of the recess relative to the bottom wall thereof. In this respect, as the stylet is advanced or withdrawn relative to the tissue site during advancement of the cutting cannula, the end walls at the opposite ends of the rece~s move against the tissue specimen and the perpendicular CA2 1 3~536 disposition of the walls tends to deflect the tissue later-ally outwardly of the recess. Thus, the quantity of tissue which is captured in the recess upon completing the advance-ment of the cutting c~nnllla is reduced relative to the opti-mum capability of the recess.
Summary of the Invention The present invention provides improvements in the con-struction of the stylet of a biopsy needle by which the foregoing problems are overcome. More particularly in this respect, the recess of a stylet in accordance with the present invention has a bottom wall parallel to the axi~ of the stylet and distal and proximal end walls between the bottom wall and the outer surface of the stylet which pro-vide the recess with an entrance end radially spaced from the bottom wall and an inner portion which is axially en-larged relative to the entrance end. This configuration of the recess is achieved by providing for at least one of the distal and proximal end walls, and preferably both, to be reentrant from the entrance end of the recess with respect to the corresponding one of the distal and proximal portions of the stylet, whereby the recess has a portion rA~ y inwardly of the entrance end which has an axial dimension greater than the axial dimension of the entrance end.
With respect to the quantity of specimen tissue which can be captured and removed from a biopsy site with a biopsy needle having a stylet according to the present invention, the reentrant disposition of each of the distal and prox;~-l end walls of the recess provides independent advantages in conjunction with the biopsy procedure and an optimum advan-tage with regard to the procedure when both end walls are reentrant. With regard to the reentrant disposition of the distal end wall of the recess, the latter provides a notch at the distal end of the recess which functions to secure the stylet in the tissue against withdrawal of the stylet while the cutting c~nnltl~ is advanced forward to complete the cutting and capturing of the specimen in the stylet re-cess. Furthermore, the rA~;~lly outer edge of the end wall is generally of elliptical contour and not in a plane per-pendicular to the stylet axis, and thus enhance cutting of ,~
5 3 ~
-the tissue specimen by rotation of the stylet prior to ad-vancement of the cutting cannula. The reentrant disposition of the proximal end wall of the recess provides a notch which functions to secure the stylet in the tissue against S advancement further into the biopsy site from the initial position during advancement of the cutting cannula to com-plete the cutting and capturing operation. Further, as with the distal end wall, the proximal end wall has an outer edge which can e~h~nce cutting of the tissue specimen.
The notches provided by the reentrant dispositions of the distal and proximal end walls of the recess provide the ~urther advantage of holding the tissue specimen firmly against the cutting recess and against lateral separation therefrom, thus to enhAnc~ cutting of the tissue when the cutting cannula is advanced and to optimize the quantity of tissue which is captured and removed from the biopsy site.
In this respect, the notch at the proximal end of the recess is driven into the tissue and the reentrant disposition of the proximal end wall pushes the tissue radially inwardly of the recess and into the corner between the proximal end wall and bottom wall of the recess and thus holds the tissue against separation from the recess. The notch at the distal end of the recess e~hAnces filling the axial length of the recess with tissue during the biopsy process in that the reentrant disposition of the distal end wall of the recess also serves to capture tissue in the notch provided thereby thus to hold the tissue against displacement radially out-wardly of the recess during advancement of the cutting cannula.
It is accordingly an out~tAn~ing object of the present invention to provide a biopsy needle stylet with an improved cutting recess structure.
Another object is the provision of a stylet of the foregoing character in which the cutting recess promotes securing the stylet in the tissue at a biopsy site against axial displacement relative thereto during a biopsy proce-dure.
.~
213~536 ' X-9336 ~_ A further object i8 the provision of a stylet of the foregoing character which optimizes the quantity of tissue which can be removed from the biopsy site during the biopsy procedure.
Yet another object i8 the provision of a stylet of the foregoing character wherein the cutting recess is structured to hold the tissue in place relative to the recess during advancement of a cutting cannula relative thereto to cut and capture the specimen in the recess.
Still a further object i8 the provision of a stylet of foregoing character in which the cutting recess includes distal and proximal end walls which are reentrant with re-spect to the distal and proximal portions of the stylet, respectively.
Still another object is the provision of a biopsy nee-dle including an improved stylet of the foregoing character.
Brief Description of the Drawings The foregoing objects,-and others, will in part be ob-vious and in part pointed out more fully hereinafter in con-junction with the written description of preferred embodi-ments of the invention illustrated in the accompanying draw-ings in which:
FIGURE 1 is an elevation view, partially in section, of a prior art biopsy needle stylet;
FIGURE 2 is a cross-sectional elevation view of the stylet taken along line 2-2 in FIGURE l;
FIGURE 3 is a side elevation view, partially in sec-tion, of a biopsy needle stylet in accordance with the present invention;
FIGURE 4 is a cross-sectional elevation view of the stylet in FIGURE 3 taken along line 4-4 therein;
FIGURE 5 is a sectional side elevation view showing the outer cannula, cutting cannula and stylet of a biopsy needle in accordance with the present invention in assembled rela-tionship prior to use of the needle;
FIGURES 6 and 7 are side elevation views, partially in section, showing the various positions of the component parts of the needle as a biopsy specimen is taken; and 213~5~6 X-9336 ~_ FIGURE 8 is a side elevation view, partially in sec-tion, of another embodiment of a biopsy needle stylet in accordance with the present invention.
Description of Preferred Embodiment~
Referring now in greater detail to the drawings, where-in the showings are for the purpose of illustrating pre-ferred embodiments of the invention only and not for the purpose of limiting the invention, FIGURES 1 and 2 illu8-trate a prior art biopsy needle stylet 10 which is solid and circular in cross-section having an axis A and a diameter which, as is well known, provides for the stylet to be slid-ably and rotatably received in a tubular inner or cutting cannula of a biopsy needle. Stylet 10 includes a distal portion 12 and a proximal portion 14 extending axially in-wardly therefrom, and the ~x;~lly outer end of distal por-tion 12 is beveled to provide a distal tip or end 16. The stylet is radially and axially cut away at a location be-tween distal end 16 and proximal portion 14 to provide a specimen receiving recess 18 and a solid portion 20 sp~nning the recess. Recess 18 includes a bottom wall 22 parallel to axis A and having axially extending laterally opposite edge~
24 which provide cutting edges for severing a specimen at the biopsy site if the stylet is rotated. Recess 18 further includes a distal end wall 26 and a proximal end wall 28, each of which extends perpendicular to bottom wall 22 and between the bottom wall and outer surface 30 of the stylet.
FIGURES 3 and 4 illustrate a modification of the recess in a stylet of the foregoing character to provide a stylet lOA in accordance with the present invention. With the ex-ception of the recess, stylet lOA corresponds to stylet 10 described above, whereby like numerals are used in FIGURES 3 and 4 to designate corresponding parts of the stylet. Re-ferring to the latter figures, stylet lOA is provided with a recess 32 having an ~x;~lly extending bottom wall 34 paral-lel to axis A and providing axially extending laterally op-posite edges 36 corresponding to edges 24 of stylet 10 in 2 1 3 'J ~ ~ b X-9336 i~ FIGURES 1 and 2. Recess 32 includes a distal end wall 38 and a proximal end wall 40, each of which extends between bottom wall 34 and outer surface 30 of the stylet and each of which, is reentrant with respect to the corresponding one of the distal and proximal portions 12 and 14 of the stylet.
The reentrant disposition of walls 38 and 40 provides for recess 32 to have an entrance end radially spaced from bot-tom wall 34 and having an axial dimension L1, and a portion rA~ially inwardly of the entrance end and having a major axial dimension L2 which is greater than dimension L1. In the ~o~;~ent illustrated in FIGURES 3 and 4, wall~ 38 and 40 are planar, and the reentrant disposition thereof is pro-vided by inclining each of the walls at an acute angle a relative to bottom wall 34. Angle a i5 between 15~and 85~
and, preferable is about 45~. Wall 38 has a radially outer edge 38a which is elliptical in contour when viewed perpen-dicular to bottom wall 34, and wall 40 ha~ a radially outer edge 40a of the same contour. Edges 38a and 40a intersect an axial plane perpendicular to bottom wall 34 at points 38b and 40b, respectively, to provide dimension L1 for the en-trance end of the recess. Further, while the intersections between walls 38 and 40 and the corresponding end of bottom wall 34 are shown as being rounded, it will be appreciated that such intersections could be defined by sharp corners or by rounded corners of larger radius than shown.
Referring now to FIGURE 5 of the drawing, stylet lOA is ~hown in assembled relationship with a tubular inner cutting cannula 42 and a tubular outer cannula 44 to provide a biop-sy needle in which the stylet and cannulas are coaxial and supported for relative axial and rotational displacement relative to one another. Inner cutting cannula 42 ha~ a distal portion 46 including tapered distal cutting edge 48 which includes a cutting tip 50 at the distal end of the cutting cannula, and outer cannula 44 ha~ a distal portion 52 including a tapered distal end 54. Inner cannula 42 has a proximal portion 56 and outer cannula 44 has a proxLmal portion 58 and, while not illustrated, it will be appre-ciated that the proximal ends of the cannulas and stylet have handles or the like to facilitate manual manipulation CA2 ~ 3~536 of the needle parts relative to one another. Alternatively, the proximal ends have the necessary connections for inter-engaging the needle parts with a gun by which the operation of the needle is automated.
When assembled, cutting cannula 42 and stylet lOA are displaceable between retracted and extended positions rela-tive to outer cannula 44 and, prior to use, are in the re-tracted positions thereof shown in FIGURE 5. In use, with the inner cannula and stylet in the retracted positions thereof, the needle is inserted into the body of a patient until the distal ends of the component parts of the needle are adjacent a lesion 60 from which a biopsy specimen is to be taken, as shown in FIGURE 5. When so positioned, stylet lOA is displaced axially outwardly relative to the outer and inner cannulas from its retracted position to its extended position in which specimen recess 32 is located at the biop-sy site in lesion 60 as shown in FIGURE 6. As will be ap-preciated from the latter Figure, the reentrant notched con-figuration of end walls 38 and 40 relative to bottom wall 34 of recess 32 stabilizes stylet lOA against axial displace-ment in the lesion and, in response to any such axial dis-placement, the walls engage and bias the adjacent ends of the tissue in the recess inwardly against bottom wall 34.
This advantageously precludes the end portions of the tissue from being displaced outwardly through the entrance into the recess during completion of the specimen cutting operation and which displacement would result in a loss of a quantity of the tissue specimen which would otherwise be captured and removed from the site.
When stylet lOA is located at the biopsy site in lesion 60 as shown in FIGURE 6, the stylet can be rotated about axis A as ; n~i cAted by arrow 62 for one of the edges 36 of bottom wall 34 and edges 38a and 40a of end walls 38 and 40 to sever the tissue at the biopsy site. The reentrant dis-position of end walls 38 and 40 of recess 32 provides the further advantage of e~hAncing cutting of tissue by rotation of stylet lOA relative to the cutting which can be achieved with a stylet in which the end walls of the recess are per-pendicular to the bottom wall thereof. In this respect, the ~
reentrant configuration captures the adjacent end portions of the tissue against~the bottom wall of the recess as de-scribed above, whereby edges 38a and 40a of the end walls are more effective in severing the tissue in response to rotation of the stylet about axis A. In any event, when stylet lOA is at the biopsy site, cutting cannula 42 is dis-placed axially outwardly relative to outer cannula 44 and stylet lOA from its retracted position shown in FIGURE 6 to its extended position shown in FIGURE 7. During such move-ment of cutting cannula 42, cutting edge 48 and tip 50 at the distal end thereof cut the tissue at the biopsy site into recess 32 and, in moving axially across the recess, cannula 42 rA~; Al ly captures a specimen S in recess 32 as shown in FIGURE 7. As mentioned hereinabove, the quantity of specimen captured in recess 32 during movement of cutting cannula 42 to the position shown in FIGURE 7 is optimized by the stabilizing effect against axial displacement of cannula lOA which is provided by the reentrant configuration of re-cess walls 38 and 40. When the tissue specimen S has been captured in recess 32 as described above, stylet lOA and cutting cannula 42 are withdrawn together from the lesion to their retracted positions relative to outer cannula 44, as shown in FIGURE 5, and the needle is then withdrawn from the patient.
FIGURE 8 illustrates another embodiment of a stylet in accordance with the present invention. In this embodiment stylet lOB is identical to stylet lOA described above with the exception of the contour of the end walls of the speci-men recess, whereby like numerals are employed in FIGURE 8 to designate the parts of stylet lOB corresponding to those of stylet lOA. In this embodiment, cutting recess 32 has distal and proximal end walls 64 and 66, respectively, which are reentrant from outer surface 30 of the stylet with re-spect to the corresponding one of the distal and proximal portions 12 and 14 of the stylet. End walls 64 and 66 are of an arcuate contour between bottom wall 34 of the reces~
and outer surface 30 of the stylet and include circum-ferentially extending rA~ ly outer side edges 64a and 66a, respectively. Edges 64a and 66a intersect an axial plane _ g _ 213~5~6 X-9336 _ perpendicular to bottom wall 34 at point~ 64b and 66b, re-spectively, to provide the recess with an entrance end hav-ing an axial dimension Ll. The reentrant disposition of end walls 64 and 66 provides for the recess to have a portion radially inwardly of the entrance end having a major axial dimension L2 which is greater than dimension Ll. As will be appreciated from the description of stylet lOA here;n~hove, the reentrant disposition of end walls 64 and 66 provides for stylet lOB to provide the same functions as end walls 38 and 40 of stylet lOA in connection with use of a biopsy nee-dle including stylet lOB.
While considerable emphasis has been placed herein on the structures of preferred embodiments of the stylets, it will be appreciated that other structures as well as mod-ifications of the disclosed structures can be made without departing from the principles of the invention. In this respect, for example, the end walls of the tissue cutting recess of the stylet can be V-shaped with the apex of the V
parallel to the bottom wall of the recess and located be-tween the bottom wall and outer surface of the stylet. Fur-ther, the reentrant confiqurations of the di~tal and proximal end walls of the recess do not have to be the same and, for example, can include a combination of a planar in-clined wall a~ shown in connection with stylet lOA together with an arcuate wall a~ shown in connection with stylet lOB.
As a further example, the acute angles between the end walls and bottom wall of stylet lOA do not have to be the same.
These and other modifications of the preferred embodiment~
as well as other embodiments of the invention will be obvi-ous and suggested to those skilled in the art, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
Claims (25)
1. In a biopsy needle for taking a biopsy specimen from a site in a patient comprising an outer tubular cannula having an axis, an inner tubular cannula coaxial with and relatively displaceably received in said outer cannula, and a stylet coaxial with and relatively displaceably received in said inner cannula, said stylet having an outer surface, a distal end, a proximal portion and a specimen recess therebetween for receiving a specimen at said site, said recess opening radially into said stylet from said outer surface and having an axially extending bottom wall and axially spaced apart distal and proximal end walls between said bottom wall and said outer surface and providing said recess with an entrance end radially spaced from said bottom wall, the improvement comprising:
said entrance end of said recess having a first axial dimension and a second axial dimension radially inward of the entrance end, said second axial dimension being greater than said first axial dimension whereby at least one of said distal and proximal end walls being reentrant from said entrance end of said recess with respect to the corresponding one of said distal end and proximal portion of said stylet.
said entrance end of said recess having a first axial dimension and a second axial dimension radially inward of the entrance end, said second axial dimension being greater than said first axial dimension whereby at least one of said distal and proximal end walls being reentrant from said entrance end of said recess with respect to the corresponding one of said distal end and proximal portion of said stylet.
2. A biopsy needle according to claim 1, wherein said at least one wall is inclined at an acute angle relative to said bottom wall.
3. A biopsy needle according to claim 2, wherein said acute angle is about 45°.
4. A biopsy needle according to claim 1, wherein said at least one wall is arcuate between said entrance end and said bottom wall.
5. A biopsy needle according to claim 1, wherein both said distal and said proximal end walls are reentrant from said entrance end.
6. A biopsy needle according to claim 5, wherein each of said distal and proximal end walls is arcuate between said entrance end and said bottom wall.
7. A biopsy needle according to claim 5, wherein each of said distal and proximal end walls is inclined at an acute angle relative to said bottom wall.
8. A biopsy needle according to claim 7, wherein said acute angle is about 45°.
9. A biopsy needle according to claim 1, wherein said entrance end of said recess is at said outer surface of said stylet and said at least one end wall is reentrant from said outer surface.
10. A biopsy needle according to claim 9, wherein both said distal and said proximal end walls are reentrant from said outer surface.
11. A biopsy needle according to claim 10, wherein each said distal and said proximal end wall is arcuate between said outer surface and said bottom wall.
12. A biopsy needle according to claim 10, wherein each said distal and said proximal end wall is planar and inclined at an acute angle with respect to said bottom wall.
13. A biopsy needle according to claim 12, wherein said acute angle is about 45°.
14. A stylet for a biopsy needle, said stylet comprising a metal body portion having an axis, a distal end, a proximal portion axially spaced from said distal end, a circular outer surface between said distal end and said proximal portion, and a specimen recess in said outer surface, said recess including an axially extending bottom wall and distal and proximal end walls between said bottom wall and said outer surface and providing said recess with an entrance end radially spaced from said bottom wall, said entrance end of said recess having a first axial dimension and a second axial dimension radially inward of the entrance end, said second axial dimension being greater than said first axial dimension whereby at least one of said distal and said proximal walls being reentrant from said entrance end with respect to the corresponding one of said distal end and proximal end portion of said stylet.
15. A stylet according to claim 14, wherein said at least one wall is inclined at an acute angle relative to said bottom wall.
16. A stylet according to claim 14, wherein said acute angle is about 45°.
17. A stylet according to claim 14, wherein said at least one wall is arcuate between said entrance end and said bottom wall.
18. A stylet according to claim 14, wherein both said distal and said proximal end walls are reentrant from said entrance end.
19. A stylet according to claim 18, wherein each of said distal and proximal end walls is arcuate between said entrance end and said bottom wall.
20. A stylet according to claim 18, wherein each of said distal and proximal end walls is inclined at an acute angle relative to said bottom wall.
21. A stylet according to claim 20, wherein said acute angle is about 45°.
22. A stylet according to claim 14, wherein said entrance end of said recess is at said outer surface of said stylet, and both said distal and said proximal end walls are reentrant from said outer surface.
23. A stylet according to claim 22, wherein each said distal and said proximal end wall is arcuate between said outer surface and said bottom wall.
24. A stylet according to claim 22, wherein each said distal and said proximal end wall is planar and inclined at an acute angle with respect to said bottom wall.
25. A stylet according to claim 24, wherein said acute angle is about 45°.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/180,972 US5394887A (en) | 1994-01-14 | 1994-01-14 | Biopsy needle |
| US08/180,972 | 1994-01-14 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2139536A1 CA2139536A1 (en) | 1995-07-15 |
| CA2139536C true CA2139536C (en) | 1998-09-22 |
Family
ID=22662367
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002139536A Expired - Fee Related CA2139536C (en) | 1994-01-14 | 1995-01-04 | Biopsy needle |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5394887A (en) |
| EP (1) | EP0663183B1 (en) |
| JP (2) | JP3198375B2 (en) |
| CA (1) | CA2139536C (en) |
| DE (1) | DE59507063D1 (en) |
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-
1994
- 1994-01-14 US US08/180,972 patent/US5394887A/en not_active Expired - Fee Related
-
1995
- 1995-01-04 CA CA002139536A patent/CA2139536C/en not_active Expired - Fee Related
- 1995-01-12 JP JP03276895A patent/JP3198375B2/en not_active Expired - Fee Related
- 1995-01-13 DE DE59507063T patent/DE59507063D1/en not_active Expired - Fee Related
- 1995-01-13 EP EP95100412A patent/EP0663183B1/en not_active Expired - Lifetime
-
2001
- 2001-02-02 JP JP2001026565A patent/JP2001252278A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA2139536A1 (en) | 1995-07-15 |
| DE59507063D1 (en) | 1999-11-25 |
| EP0663183B1 (en) | 1999-10-20 |
| US5394887A (en) | 1995-03-07 |
| JPH07250838A (en) | 1995-10-03 |
| JP2001252278A (en) | 2001-09-18 |
| JP3198375B2 (en) | 2001-08-13 |
| EP0663183A1 (en) | 1995-07-19 |
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| EEER | Examination request | ||
| MKLA | Lapsed |