CA2100481A1 - Suture clip with reduced hinge mass - Google Patents
Suture clip with reduced hinge massInfo
- Publication number
- CA2100481A1 CA2100481A1 CA002100481A CA2100481A CA2100481A1 CA 2100481 A1 CA2100481 A1 CA 2100481A1 CA 002100481 A CA002100481 A CA 002100481A CA 2100481 A CA2100481 A CA 2100481A CA 2100481 A1 CA2100481 A1 CA 2100481A1
- Authority
- CA
- Canada
- Prior art keywords
- clip
- hinge region
- leg member
- hinge
- leg
- 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.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S227/00—Elongated-member-driving apparatus
- Y10S227/902—Surgical clips or staples
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Abstract
ABSTRACT
An improved surgical clip of the type having first and second leg members joined at their proximal ends by a resilient hinge region and terminating at their distal ends in latch means. Each leg member has an outer surface and a clamping inner surface, and the outer surface of each leg member is configured to be accepted by the jaws of the clip applier. The improvement in the clip design specifically relates to a reduction in the mass of the clip in the hinge region. A reduced mass in the hinge region lessens the strain at the hinge region when the clip is in a clamped position, and therefore increases its strength retention.
An improved surgical clip of the type having first and second leg members joined at their proximal ends by a resilient hinge region and terminating at their distal ends in latch means. Each leg member has an outer surface and a clamping inner surface, and the outer surface of each leg member is configured to be accepted by the jaws of the clip applier. The improvement in the clip design specifically relates to a reduction in the mass of the clip in the hinge region. A reduced mass in the hinge region lessens the strain at the hinge region when the clip is in a clamped position, and therefore increases its strength retention.
Description
~l~Q~81 TITL O~ THE Il~VENTION
SUTURE CLIP WITH REDUCED HINGE MASS
5 BACKGROUNlI OF TH~: INVENTION
This invention relates generally to a surgical clip.
More particularly, it relates to such a clip suitably adapted to replace a suture knot during endoscopic surgery.
A~ med~cal and hospital costs continue to increase, ~urgeons are constantly striving to develop advanced ~urgical techniques. Advances in the surgical field are often related to the development of operative techniques which involve les8 invasive surgical procedures and reduce overall patient trauma. In this manner, the length of hospital stays can be significantly reduced, and therefore the hospital and medical costs can be reduced as well.
One of the truly great advances in recent year~ to reduce the invasivene~s o~ surgical procedures is endoscopic surgery. Endoscopic surg~ry involves the use of an endc3cope, which i~ an instru~ent permittinq the ~isual ~5 inspection and ~agnification of any cavity of the body.
The endoscope is in~erted through a cannula after puncture through the wall of the body cavity with a trocar, which is a sharp-pointed instrument. The surgeon can then perform diagnostic and therapeutic procedures at the surgical site with the aid of specialized instrumentation designed to fit through additional cannulas providing small diameter openings into the desired body cavity as may be required.
ET~-~52 VIA EXPRESS MAIL NO. TB123966887 ~AILED JUL`~ 16D 1992 ~1004~1 ~n age-old procedure which su~geons are required to perform to repair or reconstruct traumatized bodily tissue is suturing. Fortunately, medical instruments have been recently designed to allow a surgeon to manipulate a suture, or suture and needle combination, through the small diameter opening of a cannula. However, the ability to tie an appropriately placed suture knot endoscopically is troublesome and problematical.
Therefore, in response to this problem, surgeon3 have sought alternatives to conventional knot-tying techniques which would be suitable during endoscopic surgery. Among these alternatives include the use of hemostatic clips, which are designed to ligate blood vessels and other tubular me~bers, to replace suture knots. Such he~ostatic clip~ are described, for example, in U.S. Patent Nos.
4,418,694 and 4,476,865. These clips can be readily applied with a clip applier which is designed to function through the small opening of a cannula. Unfortunately, the force required to displace these clips from the suture is inadequately low~ As a result, hemostatic clip5 of the type shown in the art are unsuitable for general endoscopic surgery needs.
In view of the deficiencies of the prior art for creating a useful alternative to tying a suture knot, what i8 desired within the medical community i8 a device suitable for application using endoscopic techniques which can successfully replace the suture knot. More specifically, what is needed is a clip particularly adapted for replacing a suture knot during endoscopic surgery, and which exhibit~ adequate clamping force to function effectively. In those surgical procedures utilizing .:
, ~
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absorbable sutures it ~ay be preferred to use the device of the present invention in an absorbable embodiment.
S~MMARY OF TH~ INV~NTION
The invention is an improved surgical clip. The clip is of the type comprising first and second leg members joined at their proximal ends by a resilient hinge region and terminating at their distal ends in latch means. Each leg member has an outer surface and a clamping inner surface.
The clamping inner surface is disposed in oppo~ition to the cla~ping inner surface of the other leq member. The outer surface of each leg member i~ configured to be accepted by the iaW~ of a clip applier, and the hinge region has an outer hinge surface.
The improvement to the clip relates to the hinge region o~
the clip. The mass of the clip in the hinge region is reduced relative to that of a conventional clip. The ma~s i~ reduced by an amount effective to substantially lessen the strain at the hinge region when the clip i8 in a clamped position.
Surprisingly, the reduction in mass of the clip at the hinge region actually increases the ability of the hinge region t~ maintain its structural integrity over an extended period of time when the clip is in a clamped po~ition. Therefore, the ability of the clip to retain it~ clamping strength, and hence it~ nsurvival" rate in vivo, i8 dramatically improved. These improvements in properties are achieved because the ~odified design of the hinge region reduces the strain at the hinge region when the clip is i~ the clamped position.
ErH-852 '~1004~1 The clip of this invention is particularly adapted to act as a knot clip in those applications requiring the replacement of a suture knot during endoscopic surgery.
Suture knots are required when the suture strand must be 5 anchored or fastened in place. Additionally, the clip can be used for other surgical applications, particularly those applications related to endoscopic surgery. There will be instances when such a clip can be used to advantage in open surgery ( i . e ., non-endoscopic 10 procedures) .
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of the surgical clip of 15 this invention.
Figure 2 is a side view of the surgical clip of this invention in an open position.
20 Figure 3 is a side view of the surgical clip of this invention in a closed position.
Figure 4 is a perspectiva view of the conventional surqical clip of the prior art in a closed position.
Figure 5 is a side view of the conventional surgical clip of the prior art in a closed position.
Figure 6 is a perspective view of a conventional clip 30 applier for applying the surgical clip.
Figure 7 is a side view of another embodiment of the ~;urgical clip of this invention.
~.
~1 00~81 Figure 8 is a side view of yet another embodiment of the ~urgical clip of this invention.
DES~RIPTION QF THE PREFERRED EMBODIMENTS
s Referring to Figures 1-3, there is shown a surgical clip 10 of the present invention. ~he clip has first and second leg members ll and 12, re~pectively. The leg members are connected at their proximal ends by a hinge region 13, which is discussed in more detail below. The hinge region according to the present invention is resilient; i.e., it has elastîc memory and acts as a spring which assists in ~he packaging of the clip as well as the handling and placement of the clip.
First leg member 11 of the surgical clip terminates at its distal end in a hook member 14. The hook member ha# an inner face 15. In a preferred embodiment, the end surface of the hook member is beveled at 26 to assist in deflecting the hook member when the clip is closed.
The clamping inner surface 16 of the first leg member 11 of the clip has a concavQ radius of curvature extending from the hinge to the start o~ the hook member. ~e second leg member 12 has clamping inner surface 18 which has a convex radius of curvature extending from the hinge to the distal end of the leg member. The radius of curvature of the clamping surface 18 is smaller than the radius of curvature of clamping ~urface 16. Preferably, each leg member has a width substantially identical to the length of its clamping inner surface, which is about 120 mil. Second leg member 12 terminates in an end surface 19. Preferably this end surface is beveled and has a co~plementary bevel to the bevel on the hook member so as 2~0~81 to assist in the deflection of the hook member when the clip i8 closed.
Disposed on the outer surface of each leg member are s bosses 20 and 22. The bosses are used to manipulate the clip in a suitable instrument, for example, an endoscopic clip applier having a jaw formation suitable for securely grasping the clip, as will be briefly described in conjunction with Figure 6.
The clip is closed a~out a suture as shown in Figure 3 by urging th~ distal ends of the two leg ~embers together with compres~ive force directed on bosses 20 and 22. When compres~ive fsrce is applied, end surface 19 of first leg memb¢r 12 deflects the hook me~ber 14 after contact with end ~urface 26 of the hook ~ember as the two leg me~bers are pivoted about the resilient hinge 13 and closed about a suture 27. In this preferred embodiment, cylindrical boss 22 of the second leg member 12 has a contacting face 28 which abuts end surface 26 when the clip is clamped about a suture to ensure adequate and tight closure.
A critical aspect of the clip embodied in Figures 1-3 i~
the reduced ma~s of the clip in the hinge region 13, as compared with the mass of the hinge re~ion for a conventional prior art clip as shown in Figures 4 and 5.
For purposes of describing this invention, the "hinge region" of a clip is that region of the clip which physically deforms when the clip is in a clamped position.
This physical deformation occurs because the material from which the clip is composed stretches in the region of the hinge. As the degree of deformation increases, the strain on the clip increases as well. Since the deformation occurs at the hinge region, the hinge region experiences , . .
,;
8 ~
mo~t of th~ strain placed on the clip when it i8 clamped, and therefore the ~ailure rate of the clip depends ~igni~icantly on the degree o strain associated with the hinqe design.
s Surpri3ingly, a reduction in the mass of the hinge region as shown in Figures 1-3, relative to the mass in this region for prior art clip8 as embodied in Figures 4 and 5, actually lessen~ the strain at the hinge region, and therefore reduces the failure rate of the clip when in a clamped position. As shown in Figure 4 and 5, a conventional clip has a hinge region defined by an outer hinge surface which has a substantially constant radius of curvature. Advantageously, the mass in the hinge region of the clip~ of thia invention i8 reduced relative to the mass in the hinge region of a conventional clip by an amount greater than about 10 percent, preferably greater than about 15 percent.
The outer surface of the hinge region of the clip embodied in Figures 1-3 i8 configured to form a "corrugated" hinge, and has first and second curved valley regions 30 and 31, respectively~ The curved valley regions are spaced between a curved plateau region 32. The radii of curvature for each of the regions is sub~tantially equal.
The cross-sectional area of this corrugated hinge in the most preferred embodiment of thi~ invention i8 about 17 percent less than the cross-section of a regular, rounded hinge of a conventional clip (for this embodiment, the cross-sectional area would be directly proportional to its mas~ in the hinge region because the thickness of the clip in the hinge region remains substantially constant, and therefore the reduction in mas~ in the hinge region would also be about 17 percent).
21~Q~l The hinge region design shown in Figure 3, when the clip is composed of a bioabsorbable polymer such as poly(para-dioxanone), exhibits a percent of strain when the clip is in a clamped position at the hinge region of about 34 percent, as measured using standard finite element analysis techniques. The strain i8 distributed away from the proximal tip of the hinge region, and is depicted as S, in Figure 3. In contrast, the percent of strain at the hinge region of a conventional clip made of the same bioabsorbable polymer is about 56 percent, and is distributed adjacent the proximal tip of the hinge region.
This distribution is shown as Sb in Figure 5.
In another embodiment shown in Figure 7, reduced strain in the hinge region can be achieved by configuring the outer surface of the hinge region with first and second triangular valley regions 50 and 51, respectively, spaced between a triangular plateau region 52. In yet another embodiment to reduce the hings strain relative to that of a conventional clip having a rounded outer surface at the hinge region, Figure 8 shows a hinge region with ~irst and s~cond rectangular valley regions 60 and 61, respectively, spaced between rectangular valley region 62.
The clips within the scope of the present invention are suita~ly adapted for endoscopic applications to replace a conventional suture knot. This can be accomplished as illustrated in Figure 6. Referring now to Figure 6, there is shown a clip applier 70 having a long, small-diameter longitudinal member 76. Longitudinal member 76 is adapted to be inserted into a convent~onal trocar 71 through trocar cannula 77. The trocar is used to provide an opening through bodily tissue 72 for access to the surgical site. The clip applier 70 has jawe 73 at its .
,: :
210~81 dist~l end which are configured in such a manner as to facilitate grasping the outer surface of the legs of the clip 74. Clip applier 70 is maneuvered within the surgical site to place clip 74 about suture 75 which is to be clamped.
The clips of the invention can be made of any biocompatible material using conventional ~abrication methods. The clips can be composed of various biocompatible metals, e.g. titanium and tantalum, and polymeric materials. Preferably, the clips are made of bioabsorbable polymeric materials such as homopolymers and copolymers of glycolide, lactide and para-dioxanone. The most preferred polymer from which the clip is made is polydioxanone.
The preferred means for fabricating clips from bioabsorbable polymeric materials is to inject a suitable polymer melt into an appropriately designed mold at process conditions conventionally employed for such polymer systems. After the polymer melt cools, the molded polymer shaped in the mold to meet the design criteria of the clip can be readily released fro~ the mold. Ideally, the molded clip is then s~oured and annealed to optimize the crystallinity of the polymer from which the clip is derived, and therefore its dimensional stability at elevated temperatures, as well as its in vivo mechanical performance. The annealing conditions can be readily determined empirically. After annealing, the clip can be sterilized using conventional methods to render the clip suitable for surgical applications. Alternatively, numerous clip8 can be fabricated simultaneous~y by first extruding a polymer melt to form an elongate rod which i8 appropriately configured to conform to the desired cross-8 ~
sectional shape of the clip, and then slicing the rod into individual clip~ with the desired clip thicknes~.
In an especially preferred embodiment for clip~ made by S molding the clip8 from a polymer melt, a po~t-~olding technique i8 used to further improve the performance of the clip. Specifically, the clips are "flexed'^ at the hinge region over a suitably sized mandrel to significantly increase the survival rate of the clip when the clip is clamped about a suture. The flexing operation at the hinge region of the clip causes the leg members of the clip to approach one another. In the preferred embodiment, the bevel surface 26, o~ the hook member of the fir~t leg nearly touche~ the bevel surface 19, of the second leg. Advantageously, the leg members are not clo~ed 80 much so as to activate the latching mechanism.
The number of flexes may change the performance; we have found five flexs to give improved performance. For reasons possibly related to polymer morphology, flexing causes a reduction in the failure rate of the clip at the hinge region.
The post-mold flexing of the hinge region of the clip to improve its performance can be performed directly out of the mold, or within a relatively short time period thereafter, e.g. about 24 hours. In any event, flexing should generally be carried out prior to the annealing step. The diameter of the mandrel over which the clip is flexed will depend on the specific shape and dimensions of the clip, a~ well as the maximum diameter of the suture to be cla~ped between the legs of the clip. The mandrel diameter can be readily determined empirically to achieve optimu~ result~.
. .
: . .
t ' 2i~0~81 The description of these preferred embodiments should not be construed in any way to limit the scope of the claimed invention. Numerou~ additional embodiments within the scope and spirit of the invention will become readily apparent to those skilled in the art upon careful review of this specification and the following Example.
21~9~8~
EX ~Pk~
EXaMPLE 1 Suture clip Pre~aration s Suture clips configured substantially as shown in Figures 1-3 having reduced mass in the hinge region are made by in~ection molding pellets of polydioxanone polymer. The molding conditions are the following:
M~lt te~perature : 103-120C
Mold temperature : 30-55C
In~ection speed : 1.0-1.8 inches/sec.
Injection pressure: 500-950 psi ; 15 Cooling tim~ : 50-90 sec.
u~ing The clip8 are removed from the mold and put into a screened tray which is then submerged into propanol. The propanol is in a circulating bath which is turned on for 30 minutes once the clips are put into the bath. At the end of 30 minutes the clip8 are left out for one hour to air d~y. After air drying the clips are transferred to the anne~ling oven.
Anneali~q $he annealing cycle consists o~ a one hour nitrogen purge cycle at ambient temperature. At the end of the nitrogen purge cycle the oven ~witches into a heat cycle of 83C for 10.5 hours. OrAce the cycle is completed, the oven is cooled down to below 50C before the clips are re~oved.
ET~52 ~iO~81 Once the clip8 are re~oved they are placed in a nitrogen chamber for storage.
Clamping of Clip to Suture The suture clips are applied to strands of United States Pharmaecopia tUSP) size 2/0 or 3/0 VICRYL~ poly(lactide- r co-glycolide) braided suture using a standard clip applier.
Invivo Testing The clamped suture strands are implanted subcutaneously in the posterior dorsal subcutis of female Long-Evans rats weighing 250 to 300 grams. The strands remain implanted for either ten or fourteen days, and then the clamped strands are explanted to determine percent clip survival as described below.
Determination of Percent Clip Survival The suture clips of the explanted strand~ from the invivo testing ar~ analyzed for "survivaln. A clip is con3idered to have survived if the latch is completely closed over the ~uture strand and the hinge is not completely broken visually. Clips with partial hinge cracks are considered to have survived. Clips which have slipped off the suture strand are considered to have failed. The results are shown in Table 1.
~10048~.
Comparison with Conventional Clip ' Suture clip~ with a conventional hinge region but in all : remaining aspects substantially identical to the suture ~ 5 clip~ tested above are molded, processed and tested for .` percent cllp survival in accordance with the procedures ~ described above. The re~ults are shown in Table 1.
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, . .
?,100~
P~CB~r CLIP 8~RVIVA$
. size 2/o Size 3lo _ lO days 14 days 10 days 14 days _ , . .
Improved Clip~l, Percent SurYival 100 100 100 100 Conventional Clips2, Percent Survival 30 0 40 0 _ ~_ . ..... ,__ .~
~The number of improved clips tested is 10 for each suture size and time in vivo.
~rhe number of conventional clip5 tested is 10 for each suture size and time in vivo.
The results shown in Table 1 demonstrate the s$gnificantly improved surviv~l rate for the improved clips of this invention with reduced mass in the hinge region in compari~on with the survival rate of conventional clip~.
The reduced mass lessens the strain at the hinge region when the improved clips are clamped about the suture strands, so that when the cla~ped clips are explanted after 10 or 14 day~, the structural integrity o~ the clip, particularly at the hinge region, remains substantially intact. Conversely, the conventional clips lose their integrity over time when clamped about the suture strands because the clips typically fail at the hinge region where the train is significant.
.
~ .
210~81 EXAMPL~
Suture clip~ conSigured substantially as shown in Figure~
1-3 are made by in~ection molding pellets of polydioxanone in the manner described in Example 1, except that the clips are flexed 5 times at the hinge region either directly after the molding step or 24 hours after molding, as indicated, but before the annealing step.
For each experiment, 25 clips are clamped over a size 2/0 polydioxanone suture, and placed in a buffered solution at 8.5 pH held in a 37C temperature controlled bath. In vitro performance i8 judged by observing the number o~
clips which remain affixed to the suture (percent survival) at 24 and 48 hours. Thê performance results are compared with clip5 which are not flexed at the h~nge, and the overall results are 8hown in Table 2.
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21~8~
PERCENT SURVIVAL FOR HINGE-FLEXED CLIPS
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Coslditlons 24 Hour ¦ ~yp~ of 48 Hour Type of y Survival I Fallur~ SurvlYal Fa$1ur~
_ _ -- _ ~
No Fl~x$ng 76~ hingc 72~ hlnge Flexing no mandrel 68 hinge 42 hinge 1exed directly after molding Flax~nqs no mandrel76 h$nge 48 hing~
floxed 24 hour~ aft~r mold~ng Flexing 22 mil mandr~l 96 h$nge 88 hinge fluxed directly after moldlng Fl-xLngs 22 mil mandr~l 100 84 hlnge flexed 24 hour~ aft~r molding Fl~xings 33 mil mandrel 92 latch 84 hinge fl-xod d~rectly atar ~olding Fl-xlngs 33 mil mnndrel 88 latch 80 hinge fl~x-d 24 hour- aft~r molding NOTESs Each hinge f lexed S S~e~
25 cl~p~ u~ed per experiment In vitro condit;onus 37~, 8 5 p~
E~nN-852 .
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~ao4~l The result~ shown in Table 2 demonstrate that clipæ flexed over an appropriately-sized mandrel at the hinge region exhibit improved survival relative to the æurvival shown for clips which are not flexed or are not flexed over a mandrel.
,,-.
~ ,
SUTURE CLIP WITH REDUCED HINGE MASS
5 BACKGROUNlI OF TH~: INVENTION
This invention relates generally to a surgical clip.
More particularly, it relates to such a clip suitably adapted to replace a suture knot during endoscopic surgery.
A~ med~cal and hospital costs continue to increase, ~urgeons are constantly striving to develop advanced ~urgical techniques. Advances in the surgical field are often related to the development of operative techniques which involve les8 invasive surgical procedures and reduce overall patient trauma. In this manner, the length of hospital stays can be significantly reduced, and therefore the hospital and medical costs can be reduced as well.
One of the truly great advances in recent year~ to reduce the invasivene~s o~ surgical procedures is endoscopic surgery. Endoscopic surg~ry involves the use of an endc3cope, which i~ an instru~ent permittinq the ~isual ~5 inspection and ~agnification of any cavity of the body.
The endoscope is in~erted through a cannula after puncture through the wall of the body cavity with a trocar, which is a sharp-pointed instrument. The surgeon can then perform diagnostic and therapeutic procedures at the surgical site with the aid of specialized instrumentation designed to fit through additional cannulas providing small diameter openings into the desired body cavity as may be required.
ET~-~52 VIA EXPRESS MAIL NO. TB123966887 ~AILED JUL`~ 16D 1992 ~1004~1 ~n age-old procedure which su~geons are required to perform to repair or reconstruct traumatized bodily tissue is suturing. Fortunately, medical instruments have been recently designed to allow a surgeon to manipulate a suture, or suture and needle combination, through the small diameter opening of a cannula. However, the ability to tie an appropriately placed suture knot endoscopically is troublesome and problematical.
Therefore, in response to this problem, surgeon3 have sought alternatives to conventional knot-tying techniques which would be suitable during endoscopic surgery. Among these alternatives include the use of hemostatic clips, which are designed to ligate blood vessels and other tubular me~bers, to replace suture knots. Such he~ostatic clip~ are described, for example, in U.S. Patent Nos.
4,418,694 and 4,476,865. These clips can be readily applied with a clip applier which is designed to function through the small opening of a cannula. Unfortunately, the force required to displace these clips from the suture is inadequately low~ As a result, hemostatic clip5 of the type shown in the art are unsuitable for general endoscopic surgery needs.
In view of the deficiencies of the prior art for creating a useful alternative to tying a suture knot, what i8 desired within the medical community i8 a device suitable for application using endoscopic techniques which can successfully replace the suture knot. More specifically, what is needed is a clip particularly adapted for replacing a suture knot during endoscopic surgery, and which exhibit~ adequate clamping force to function effectively. In those surgical procedures utilizing .:
, ~
' . :
. ~
absorbable sutures it ~ay be preferred to use the device of the present invention in an absorbable embodiment.
S~MMARY OF TH~ INV~NTION
The invention is an improved surgical clip. The clip is of the type comprising first and second leg members joined at their proximal ends by a resilient hinge region and terminating at their distal ends in latch means. Each leg member has an outer surface and a clamping inner surface.
The clamping inner surface is disposed in oppo~ition to the cla~ping inner surface of the other leq member. The outer surface of each leg member i~ configured to be accepted by the iaW~ of a clip applier, and the hinge region has an outer hinge surface.
The improvement to the clip relates to the hinge region o~
the clip. The mass of the clip in the hinge region is reduced relative to that of a conventional clip. The ma~s i~ reduced by an amount effective to substantially lessen the strain at the hinge region when the clip i8 in a clamped position.
Surprisingly, the reduction in mass of the clip at the hinge region actually increases the ability of the hinge region t~ maintain its structural integrity over an extended period of time when the clip is in a clamped po~ition. Therefore, the ability of the clip to retain it~ clamping strength, and hence it~ nsurvival" rate in vivo, i8 dramatically improved. These improvements in properties are achieved because the ~odified design of the hinge region reduces the strain at the hinge region when the clip is i~ the clamped position.
ErH-852 '~1004~1 The clip of this invention is particularly adapted to act as a knot clip in those applications requiring the replacement of a suture knot during endoscopic surgery.
Suture knots are required when the suture strand must be 5 anchored or fastened in place. Additionally, the clip can be used for other surgical applications, particularly those applications related to endoscopic surgery. There will be instances when such a clip can be used to advantage in open surgery ( i . e ., non-endoscopic 10 procedures) .
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of the surgical clip of 15 this invention.
Figure 2 is a side view of the surgical clip of this invention in an open position.
20 Figure 3 is a side view of the surgical clip of this invention in a closed position.
Figure 4 is a perspectiva view of the conventional surqical clip of the prior art in a closed position.
Figure 5 is a side view of the conventional surgical clip of the prior art in a closed position.
Figure 6 is a perspective view of a conventional clip 30 applier for applying the surgical clip.
Figure 7 is a side view of another embodiment of the ~;urgical clip of this invention.
~.
~1 00~81 Figure 8 is a side view of yet another embodiment of the ~urgical clip of this invention.
DES~RIPTION QF THE PREFERRED EMBODIMENTS
s Referring to Figures 1-3, there is shown a surgical clip 10 of the present invention. ~he clip has first and second leg members ll and 12, re~pectively. The leg members are connected at their proximal ends by a hinge region 13, which is discussed in more detail below. The hinge region according to the present invention is resilient; i.e., it has elastîc memory and acts as a spring which assists in ~he packaging of the clip as well as the handling and placement of the clip.
First leg member 11 of the surgical clip terminates at its distal end in a hook member 14. The hook member ha# an inner face 15. In a preferred embodiment, the end surface of the hook member is beveled at 26 to assist in deflecting the hook member when the clip is closed.
The clamping inner surface 16 of the first leg member 11 of the clip has a concavQ radius of curvature extending from the hinge to the start o~ the hook member. ~e second leg member 12 has clamping inner surface 18 which has a convex radius of curvature extending from the hinge to the distal end of the leg member. The radius of curvature of the clamping surface 18 is smaller than the radius of curvature of clamping ~urface 16. Preferably, each leg member has a width substantially identical to the length of its clamping inner surface, which is about 120 mil. Second leg member 12 terminates in an end surface 19. Preferably this end surface is beveled and has a co~plementary bevel to the bevel on the hook member so as 2~0~81 to assist in the deflection of the hook member when the clip i8 closed.
Disposed on the outer surface of each leg member are s bosses 20 and 22. The bosses are used to manipulate the clip in a suitable instrument, for example, an endoscopic clip applier having a jaw formation suitable for securely grasping the clip, as will be briefly described in conjunction with Figure 6.
The clip is closed a~out a suture as shown in Figure 3 by urging th~ distal ends of the two leg ~embers together with compres~ive force directed on bosses 20 and 22. When compres~ive fsrce is applied, end surface 19 of first leg memb¢r 12 deflects the hook me~ber 14 after contact with end ~urface 26 of the hook ~ember as the two leg me~bers are pivoted about the resilient hinge 13 and closed about a suture 27. In this preferred embodiment, cylindrical boss 22 of the second leg member 12 has a contacting face 28 which abuts end surface 26 when the clip is clamped about a suture to ensure adequate and tight closure.
A critical aspect of the clip embodied in Figures 1-3 i~
the reduced ma~s of the clip in the hinge region 13, as compared with the mass of the hinge re~ion for a conventional prior art clip as shown in Figures 4 and 5.
For purposes of describing this invention, the "hinge region" of a clip is that region of the clip which physically deforms when the clip is in a clamped position.
This physical deformation occurs because the material from which the clip is composed stretches in the region of the hinge. As the degree of deformation increases, the strain on the clip increases as well. Since the deformation occurs at the hinge region, the hinge region experiences , . .
,;
8 ~
mo~t of th~ strain placed on the clip when it i8 clamped, and therefore the ~ailure rate of the clip depends ~igni~icantly on the degree o strain associated with the hinqe design.
s Surpri3ingly, a reduction in the mass of the hinge region as shown in Figures 1-3, relative to the mass in this region for prior art clip8 as embodied in Figures 4 and 5, actually lessen~ the strain at the hinge region, and therefore reduces the failure rate of the clip when in a clamped position. As shown in Figure 4 and 5, a conventional clip has a hinge region defined by an outer hinge surface which has a substantially constant radius of curvature. Advantageously, the mass in the hinge region of the clip~ of thia invention i8 reduced relative to the mass in the hinge region of a conventional clip by an amount greater than about 10 percent, preferably greater than about 15 percent.
The outer surface of the hinge region of the clip embodied in Figures 1-3 i8 configured to form a "corrugated" hinge, and has first and second curved valley regions 30 and 31, respectively~ The curved valley regions are spaced between a curved plateau region 32. The radii of curvature for each of the regions is sub~tantially equal.
The cross-sectional area of this corrugated hinge in the most preferred embodiment of thi~ invention i8 about 17 percent less than the cross-section of a regular, rounded hinge of a conventional clip (for this embodiment, the cross-sectional area would be directly proportional to its mas~ in the hinge region because the thickness of the clip in the hinge region remains substantially constant, and therefore the reduction in mas~ in the hinge region would also be about 17 percent).
21~Q~l The hinge region design shown in Figure 3, when the clip is composed of a bioabsorbable polymer such as poly(para-dioxanone), exhibits a percent of strain when the clip is in a clamped position at the hinge region of about 34 percent, as measured using standard finite element analysis techniques. The strain i8 distributed away from the proximal tip of the hinge region, and is depicted as S, in Figure 3. In contrast, the percent of strain at the hinge region of a conventional clip made of the same bioabsorbable polymer is about 56 percent, and is distributed adjacent the proximal tip of the hinge region.
This distribution is shown as Sb in Figure 5.
In another embodiment shown in Figure 7, reduced strain in the hinge region can be achieved by configuring the outer surface of the hinge region with first and second triangular valley regions 50 and 51, respectively, spaced between a triangular plateau region 52. In yet another embodiment to reduce the hings strain relative to that of a conventional clip having a rounded outer surface at the hinge region, Figure 8 shows a hinge region with ~irst and s~cond rectangular valley regions 60 and 61, respectively, spaced between rectangular valley region 62.
The clips within the scope of the present invention are suita~ly adapted for endoscopic applications to replace a conventional suture knot. This can be accomplished as illustrated in Figure 6. Referring now to Figure 6, there is shown a clip applier 70 having a long, small-diameter longitudinal member 76. Longitudinal member 76 is adapted to be inserted into a convent~onal trocar 71 through trocar cannula 77. The trocar is used to provide an opening through bodily tissue 72 for access to the surgical site. The clip applier 70 has jawe 73 at its .
,: :
210~81 dist~l end which are configured in such a manner as to facilitate grasping the outer surface of the legs of the clip 74. Clip applier 70 is maneuvered within the surgical site to place clip 74 about suture 75 which is to be clamped.
The clips of the invention can be made of any biocompatible material using conventional ~abrication methods. The clips can be composed of various biocompatible metals, e.g. titanium and tantalum, and polymeric materials. Preferably, the clips are made of bioabsorbable polymeric materials such as homopolymers and copolymers of glycolide, lactide and para-dioxanone. The most preferred polymer from which the clip is made is polydioxanone.
The preferred means for fabricating clips from bioabsorbable polymeric materials is to inject a suitable polymer melt into an appropriately designed mold at process conditions conventionally employed for such polymer systems. After the polymer melt cools, the molded polymer shaped in the mold to meet the design criteria of the clip can be readily released fro~ the mold. Ideally, the molded clip is then s~oured and annealed to optimize the crystallinity of the polymer from which the clip is derived, and therefore its dimensional stability at elevated temperatures, as well as its in vivo mechanical performance. The annealing conditions can be readily determined empirically. After annealing, the clip can be sterilized using conventional methods to render the clip suitable for surgical applications. Alternatively, numerous clip8 can be fabricated simultaneous~y by first extruding a polymer melt to form an elongate rod which i8 appropriately configured to conform to the desired cross-8 ~
sectional shape of the clip, and then slicing the rod into individual clip~ with the desired clip thicknes~.
In an especially preferred embodiment for clip~ made by S molding the clip8 from a polymer melt, a po~t-~olding technique i8 used to further improve the performance of the clip. Specifically, the clips are "flexed'^ at the hinge region over a suitably sized mandrel to significantly increase the survival rate of the clip when the clip is clamped about a suture. The flexing operation at the hinge region of the clip causes the leg members of the clip to approach one another. In the preferred embodiment, the bevel surface 26, o~ the hook member of the fir~t leg nearly touche~ the bevel surface 19, of the second leg. Advantageously, the leg members are not clo~ed 80 much so as to activate the latching mechanism.
The number of flexes may change the performance; we have found five flexs to give improved performance. For reasons possibly related to polymer morphology, flexing causes a reduction in the failure rate of the clip at the hinge region.
The post-mold flexing of the hinge region of the clip to improve its performance can be performed directly out of the mold, or within a relatively short time period thereafter, e.g. about 24 hours. In any event, flexing should generally be carried out prior to the annealing step. The diameter of the mandrel over which the clip is flexed will depend on the specific shape and dimensions of the clip, a~ well as the maximum diameter of the suture to be cla~ped between the legs of the clip. The mandrel diameter can be readily determined empirically to achieve optimu~ result~.
. .
: . .
t ' 2i~0~81 The description of these preferred embodiments should not be construed in any way to limit the scope of the claimed invention. Numerou~ additional embodiments within the scope and spirit of the invention will become readily apparent to those skilled in the art upon careful review of this specification and the following Example.
21~9~8~
EX ~Pk~
EXaMPLE 1 Suture clip Pre~aration s Suture clips configured substantially as shown in Figures 1-3 having reduced mass in the hinge region are made by in~ection molding pellets of polydioxanone polymer. The molding conditions are the following:
M~lt te~perature : 103-120C
Mold temperature : 30-55C
In~ection speed : 1.0-1.8 inches/sec.
Injection pressure: 500-950 psi ; 15 Cooling tim~ : 50-90 sec.
u~ing The clip8 are removed from the mold and put into a screened tray which is then submerged into propanol. The propanol is in a circulating bath which is turned on for 30 minutes once the clips are put into the bath. At the end of 30 minutes the clip8 are left out for one hour to air d~y. After air drying the clips are transferred to the anne~ling oven.
Anneali~q $he annealing cycle consists o~ a one hour nitrogen purge cycle at ambient temperature. At the end of the nitrogen purge cycle the oven ~witches into a heat cycle of 83C for 10.5 hours. OrAce the cycle is completed, the oven is cooled down to below 50C before the clips are re~oved.
ET~52 ~iO~81 Once the clip8 are re~oved they are placed in a nitrogen chamber for storage.
Clamping of Clip to Suture The suture clips are applied to strands of United States Pharmaecopia tUSP) size 2/0 or 3/0 VICRYL~ poly(lactide- r co-glycolide) braided suture using a standard clip applier.
Invivo Testing The clamped suture strands are implanted subcutaneously in the posterior dorsal subcutis of female Long-Evans rats weighing 250 to 300 grams. The strands remain implanted for either ten or fourteen days, and then the clamped strands are explanted to determine percent clip survival as described below.
Determination of Percent Clip Survival The suture clips of the explanted strand~ from the invivo testing ar~ analyzed for "survivaln. A clip is con3idered to have survived if the latch is completely closed over the ~uture strand and the hinge is not completely broken visually. Clips with partial hinge cracks are considered to have survived. Clips which have slipped off the suture strand are considered to have failed. The results are shown in Table 1.
~10048~.
Comparison with Conventional Clip ' Suture clip~ with a conventional hinge region but in all : remaining aspects substantially identical to the suture ~ 5 clip~ tested above are molded, processed and tested for .` percent cllp survival in accordance with the procedures ~ described above. The re~ults are shown in Table 1.
' ~
,~:
.:
. " . .
, . . .
~ .~
,1 :, , ~
, ~ , . : . . .. .
, . .
?,100~
P~CB~r CLIP 8~RVIVA$
. size 2/o Size 3lo _ lO days 14 days 10 days 14 days _ , . .
Improved Clip~l, Percent SurYival 100 100 100 100 Conventional Clips2, Percent Survival 30 0 40 0 _ ~_ . ..... ,__ .~
~The number of improved clips tested is 10 for each suture size and time in vivo.
~rhe number of conventional clip5 tested is 10 for each suture size and time in vivo.
The results shown in Table 1 demonstrate the s$gnificantly improved surviv~l rate for the improved clips of this invention with reduced mass in the hinge region in compari~on with the survival rate of conventional clip~.
The reduced mass lessens the strain at the hinge region when the improved clips are clamped about the suture strands, so that when the cla~ped clips are explanted after 10 or 14 day~, the structural integrity o~ the clip, particularly at the hinge region, remains substantially intact. Conversely, the conventional clips lose their integrity over time when clamped about the suture strands because the clips typically fail at the hinge region where the train is significant.
.
~ .
210~81 EXAMPL~
Suture clip~ conSigured substantially as shown in Figure~
1-3 are made by in~ection molding pellets of polydioxanone in the manner described in Example 1, except that the clips are flexed 5 times at the hinge region either directly after the molding step or 24 hours after molding, as indicated, but before the annealing step.
For each experiment, 25 clips are clamped over a size 2/0 polydioxanone suture, and placed in a buffered solution at 8.5 pH held in a 37C temperature controlled bath. In vitro performance i8 judged by observing the number o~
clips which remain affixed to the suture (percent survival) at 24 and 48 hours. Thê performance results are compared with clip5 which are not flexed at the h~nge, and the overall results are 8hown in Table 2.
,. ~- !
.'.: : ` ` `:
` ' '`" ~' ' ' ':
`
21~8~
PERCENT SURVIVAL FOR HINGE-FLEXED CLIPS
-- , U
Coslditlons 24 Hour ¦ ~yp~ of 48 Hour Type of y Survival I Fallur~ SurvlYal Fa$1ur~
_ _ -- _ ~
No Fl~x$ng 76~ hingc 72~ hlnge Flexing no mandrel 68 hinge 42 hinge 1exed directly after molding Flax~nqs no mandrel76 h$nge 48 hing~
floxed 24 hour~ aft~r mold~ng Flexing 22 mil mandr~l 96 h$nge 88 hinge fluxed directly after moldlng Fl-xLngs 22 mil mandr~l 100 84 hlnge flexed 24 hour~ aft~r molding Fl~xings 33 mil mandrel 92 latch 84 hinge fl-xod d~rectly atar ~olding Fl-xlngs 33 mil mnndrel 88 latch 80 hinge fl~x-d 24 hour- aft~r molding NOTESs Each hinge f lexed S S~e~
25 cl~p~ u~ed per experiment In vitro condit;onus 37~, 8 5 p~
E~nN-852 .
~; -;
"':
~ao4~l The result~ shown in Table 2 demonstrate that clipæ flexed over an appropriately-sized mandrel at the hinge region exhibit improved survival relative to the æurvival shown for clips which are not flexed or are not flexed over a mandrel.
,,-.
~ ,
Claims (14)
1. An improved surgical clip of the type having first and second leg members joined at their proximal ends by a resilient hinge region and terminating at their distal ends in latch means, each leg member having an outer leg surface and a clamping inner surface, said clamping inner surface being in opposition to the clamping inner surface of the other leg member, the outer leg surface of each leg member being configured to be accepted by the jaws of a clip applier, and said resilient hinge region having an outer hinge surface;
the improvement wherein the mass of the clip in the hinge region is reduced relative to that of a conventional clip by an amount effective to substantially lessen the strain at said hinge region when the clip is in a clamped position.
the improvement wherein the mass of the clip in the hinge region is reduced relative to that of a conventional clip by an amount effective to substantially lessen the strain at said hinge region when the clip is in a clamped position.
2. The clip of claim 1 wherein the mass of the clip in the hinge region is reduced by an amount greater than about 10 percent.
3. The clip of claim 2 wherein the mass of the clip in the hinge region is reduced by an amount greater than about 15 percent.
4. The clip of claim 3 wherein the outer hinge surface of said hinge region has first and second curved valley regions, said curved valley regions spaced between a curved plateau region.
5. The clip of claim 4 wherein each of said curved valley regions and said curved plateau region have substantially identical radii of curvature.
6. The clip of claim 3 wherein the outer hinge surface of said hinge region has first and second triangular valley regions, said triangular valley regions spaced between a triangular plateau region.
7. The clip of claim 3 wherein the outer hinge surface of said hinge region has first and second rectangular valley regions, said rectangular valley regions spaced between a rectangular plateau region.
8. The clip of claim 5 wherein said first leg member terminates at its distal end thereof with a deflectable hook member.
9. The clip of claim 8 wherein the clamping inner surface of said first leg member has a concave radius of curvature between the hinge region and the hook member, and the clamping inner surface of said second leg member has a convex radius of curvature between the hinge region and its distal end, the radius of curvature of the clamping inner surface of said second leg member being smaller than the radius of curvature of the clamping inner surface of said first leg member.
10. The clip of claim 9 wherein the outer leg surface of each leg member includes a boss to facilitate engagement of said clip by the jaws of a clip applier.
11. The clip of claim 10 wherein each leg member has a width which is substantially identical to the length of the clamping inner surface of said leg member.
12. The clip of claim 11 wherein said width is about 120 mil.
13. The clip of claim 1 wherein said clip is made by injection molding a polymer melt into a mold for the clip, and said molded clip is flexed over a mandrel at the hinge region after said molding step.
14. The clip of claim 13 wherein said clip is annealed after said flexing step.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/915,155 US5234449A (en) | 1992-07-16 | 1992-07-16 | Suture clip with reduced hinge mass |
| US915,155 | 1992-07-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2100481A1 true CA2100481A1 (en) | 1994-01-17 |
Family
ID=25435318
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002100481A Abandoned CA2100481A1 (en) | 1992-07-16 | 1993-07-14 | Suture clip with reduced hinge mass |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5234449A (en) |
| EP (1) | EP0579495B1 (en) |
| JP (1) | JPH06277222A (en) |
| AU (1) | AU662693B2 (en) |
| BR (1) | BR9302885A (en) |
| CA (1) | CA2100481A1 (en) |
| DE (1) | DE69314109T2 (en) |
| IL (1) | IL106223A (en) |
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| US10939905B2 (en) | 2016-08-26 | 2021-03-09 | Edwards Lifesciences Corporation | Suture clips, deployment devices therefor, and methods of use |
| US10863980B2 (en) | 2016-12-28 | 2020-12-15 | Edwards Lifesciences Corporation | Suture fastener having spaced-apart layers |
| EP3600082A4 (en) | 2017-03-21 | 2020-09-16 | Teleflex Medical Incorporated | Surgical clip and clip applier |
| US11266408B2 (en) | 2017-03-21 | 2022-03-08 | Teleflex Medical Incorporated | Clip applier having stabilizing member |
| EP3600083A4 (en) | 2017-03-21 | 2021-03-31 | Teleflex Medical Incorporated | Flexible stabilizing member for a clip applier |
| CA3068282C (en) * | 2017-06-22 | 2022-06-28 | Teleflex Medical Incorporated | Surgical clip |
| USD808522S1 (en) * | 2017-07-11 | 2018-01-23 | Vesolock Medical, Llc | Latching ends of a polymer ligating clip |
| US11291459B2 (en) | 2017-10-30 | 2022-04-05 | Teleflex Medical Incorporated | Latching wire clip |
| KR102482377B1 (en) | 2017-11-14 | 2022-12-29 | 텔리플렉스 메디컬 인코포레이티드 | surgical clip |
| US11324496B2 (en) * | 2018-02-15 | 2022-05-10 | Vquad Medical LLC | Suture clip and suture clip applier |
| AU2019235774B2 (en) | 2018-03-14 | 2021-01-28 | Boston Scientific Scimed, Inc. | Tissue retraction device and delivery system |
| US11317923B2 (en) * | 2018-08-13 | 2022-05-03 | Covidien Lp | Ligation clip with improved hinge |
| US20210030420A1 (en) * | 2019-08-02 | 2021-02-04 | Covidien Lp | Ligation clip with improved latch mechanism |
| US11696764B2 (en) | 2020-01-31 | 2023-07-11 | Covidien Lp | Ligation clip with controlled tissue compression |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3874042A (en) * | 1973-01-22 | 1975-04-01 | Biospectrum Inc | Clamp for thin walled tubing |
| DE2525650C3 (en) * | 1975-06-09 | 1978-05-24 | B. Braun Melsungen Ag, 3508 Melsungen | Clamp for blocking fallopian tubes and vas deferens in the human and animal body |
| US4418694A (en) * | 1979-06-18 | 1983-12-06 | Ethicon, Inc. | Non-metallic, bio-compatible hemostatic clips |
| US4382453A (en) * | 1979-06-27 | 1983-05-10 | Abbott Laboratories | Flow ristrictor for flexible tubing |
| US4446865A (en) * | 1981-03-16 | 1984-05-08 | Ethicon, Inc. | Plastic ligating clips |
| US4449530A (en) * | 1981-07-15 | 1984-05-22 | Ethicon, Inc. | Hemostatic clips and method of manufacture |
| US4476865A (en) * | 1982-02-12 | 1984-10-16 | Ethicon, Inc. | Non-metallic, bio-compatible hemostatic clips |
| US4458682A (en) * | 1982-08-02 | 1984-07-10 | Ethicon, Inc. | Non-metallic, bio-compatible hemostatic clips (ring lock clips) |
| US4579118A (en) * | 1983-06-01 | 1986-04-01 | Ethicon, Inc. | Hemostatic clip with penetration means |
| JPH0657218B2 (en) * | 1985-05-10 | 1994-08-03 | エチコン・インコ−ポレ−テツド | Ligation clip and clip application device |
| US4834096A (en) * | 1987-10-26 | 1989-05-30 | Edward Weck Incorporated | Plastic ligating clips |
| US5062846A (en) * | 1989-03-28 | 1991-11-05 | Edward Weck Incorporated | Penetrating plastic ligating clip |
| US5062848A (en) * | 1990-03-07 | 1991-11-05 | Frazee John G | Hemostatic clip and applicator therefor |
-
1992
- 1992-07-16 US US07/915,155 patent/US5234449A/en not_active Expired - Lifetime
-
1993
- 1993-07-04 IL IL106223A patent/IL106223A/en not_active IP Right Cessation
- 1993-07-12 AU AU41882/93A patent/AU662693B2/en not_active Ceased
- 1993-07-13 JP JP5195275A patent/JPH06277222A/en active Pending
- 1993-07-14 CA CA002100481A patent/CA2100481A1/en not_active Abandoned
- 1993-07-15 BR BR9302885A patent/BR9302885A/en not_active Application Discontinuation
- 1993-07-15 EP EP93305556A patent/EP0579495B1/en not_active Expired - Lifetime
- 1993-07-15 DE DE69314109T patent/DE69314109T2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| BR9302885A (en) | 1994-02-22 |
| AU4188293A (en) | 1994-01-20 |
| US5234449A (en) | 1993-08-10 |
| IL106223A0 (en) | 1993-11-15 |
| EP0579495A1 (en) | 1994-01-19 |
| DE69314109T2 (en) | 1998-02-19 |
| AU662693B2 (en) | 1995-09-07 |
| EP0579495B1 (en) | 1997-09-24 |
| IL106223A (en) | 1998-01-04 |
| DE69314109D1 (en) | 1997-10-30 |
| JPH06277222A (en) | 1994-10-04 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |