CA2173869A1 - A suture anchor - Google Patents

A suture anchor

Info

Publication number
CA2173869A1
CA2173869A1 CA 2173869 CA2173869A CA2173869A1 CA 2173869 A1 CA2173869 A1 CA 2173869A1 CA 2173869 CA2173869 CA 2173869 CA 2173869 A CA2173869 A CA 2173869A CA 2173869 A1 CA2173869 A1 CA 2173869A1
Authority
CA
Grant status
Application
Patent type
Prior art keywords
suture
wedge
holes
hole
embodiment
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
Application number
CA 2173869
Other languages
French (fr)
Inventor
Javin Pierce
Original Assignee
Javin Pierce
Priority date (The priority date 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 date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/08Muscles; Tendons; Ligaments
    • A61F2/0811Fixation devices for tendons or ligaments

Abstract

One embodiment of the instant invention is made up of a guide wire component (13), a proximal wedge component (14) and a distal wedge component (15). In a second preferred embodiment, a uniquely designed surgical wedge anchor is provided having a barbed top portion (105), a plurality of suture holes (101, 102, 101b, 102b, 103, 103b) and a centrally located lower tooth (106) within a rounded notch in a lower-most portion (122).

Description

WO95/11631 ~ ~ 3~6 ~ PCT~S94/12389 .

3 Background of the Invention Field of the Invention 6 The instant invention relates to that panoply of 7 devices that serve to anchor to bone, or soft tissue, 8 suture materials for the purpose of facilitating adherence 9 of soft tissues such as muscle and ligament tissues in close apposition to such bone by way of such suture 11 materials being sewn thereto and therein.
12 Brief Description of Related Prior Art 13 The following patents may bear somewhat on the essence 14 of the instant invention. However, the instant invention represents a manifest improvement upon and variation from 16 any other arguable similar devices current in or out of 17 vogue within the scope of the field of such devices.

19 Title Issue 20 Inventor(s) Invention U.S.Patent No. Date 22 Goble et al Harpoon Suture 5,141,520 8/25/92 23 Anchor Gatturna et al Suture Anchor 4,898,156 2/6/90 27 Chow Surgical 5,176,682 1/5/93 28 Implement Anspach, Jr. Suture Anchor 5,102,421 4/7/92 31 and Method of 32 Forming 34 Fischer et al Bone Fastener 4,716,893 1/5/88 36 Goble et al Ligament Anchor 4,870,957 10/3/89 37 System 39 Hayhurst et al Bone Anchor and 5,037,422 8/6/91 Method of 41 Anchoring a 42 Suture to a Bone 44 There are numerous and various types of anchor devices in existence today that are designed to facilitate the WO95/11631 ~ PCT~S94112389 ~ 2-1 holding of soft tissue to bone by way of holding surgical 2 sutures sewn into such soft tissue. But, these devices and 3 means such as screws with loops on their crowns, glues and 4 the like are universally amenable to failure over time due to, for example, degradation of bone, breakage at joints 6 within such devices or adhesive defects. Such failure 7 requires readmission of affected patients to surgery and 8 subjugation of such persons to inherent risks and 9 inexorable expense related to the same. Hence, the essential object of the instant invention is to obviate, to 11 the fullest possible extent, such failure.
12 The instant invention has no relatively delicate joint 13 sites. One embodiment functions by way of action-reaction 14 laterally directed and hence once wedged into place simply cannot come loose under the influence of whatever 16 physiological load force as could conceivably be applied to 17 it. Another embodiment functions by way of toggle movement 18 laterally directed and hence once lodged into place cannot 19 come loose under physiological force load.
The instant invention is, respectfully submitted, in 21 view of the foregoing, new, indeed revolutionary within its 22 field and unquestionably useful and unique in that it 23 functions in a truly new and unique way as a viable anchor.
24 Moreover, in view of its new and unique type of framework, its dependability from a standpoint of essentially non-26 susceptibility to breakage in situ is beyond reproach.
27 Also, the second embodiment of the instant invention 28 constitutes a significant improvement, over the suture 29 anchor of the first embodiment since, the relative complexity of and cost of manufacture of the proximal wedge 31 component thereof exceed not insignificantly the same as 32 respects any of the above-mentioned distal wedge 33 embodiments. Moreover, the barbed tip and lower tooth 34 features of the above-mentioned embodiment facilitates even more effective embedding into tissue material especially 36 bone than does the beveled top edge of the distal wedge 2 ~ 73~6~

1 component of the suture anchor especially absent the 2 presence of that device's proximal wedge component.
3 Finally, the device of this second embodiment is 4 likewise essentially non-breakable, and, for all of the foregoing reasons, respectfully stated, constitutes a new, 6 useful, and unique advancement in the art relating to 7 devices of this nature.
8 Summary of the Invention 9 One preferred embodiment of the instant invention is made up of three essential components. One is a so-called 11 distal wedge. A second is a so-called proximal wedge.
12 And, the third is a guide wire to which the first two 13 components are fastened but amenable to removal therefrom.
14 A surgeon utilizes this embodiment of the instant invention by first resorting to utilization of a cannulated 16 drill bit and drilled a hole into bone. Then the surgeon 17 inserts the guide wire component of the instant invention 18 through the lumen of the embedded drill bit after having 19 first removed the drill therefrom by loosening the drill chuck and pulling the drill away. Once the guide wire is 21 within the lumen of the bit, then the drill bit is removed 22 by holding the guide wire with one hand and pulling out the 23 bit with the other by way of a pincer device after having 24 first removed the proximal wedge and distal wedge components from the guide wire component. Then the hand 26 holding the guide wire above the removed bit is placed 27 below the bit to continue holding the wire in place in the 28 drilled hole while the bit is pulled up and off the wire.
29 Then the wedge components are placed back on the guide wire after first threading suture wire through the distal wedge 31 component and the wedge components are guided down the 32 guide wire in the drilled hole and tamped down into place 33 within the drilled hole. An insertion tool is utilized for 34 such purpose. Then the guide wire component is removed from the drilled hole. Once the wedge components of the 36 invention are in place, then downward pressure is applied WO95/11631 PCT~S94/12389 ~13~6q ~4~

1 to the head of the proximal wedge component by pushing down 2 on it with the insertion tool to push it into the drilled 3 hole while upward pressure is applied to the suture thread 4 previously threaded through and about the base of the distal wedge. This combination of pushing and pulling 6 causes the distal wedge to slide upwards against the 7 proximal wedge being pushed downward. This action of 8 sliding upward causes the inclined medial faces of each 9 wedge component to slide over one another and to concomitantly push each wedge component laterally out 11 against the sides of the drilled hole. The wedge 12 components are thus pressed firmly and permanently into 13 place by virtue of the increase in the central diameter of 14 the two wedge components in interfaced apposition to one another in situ after application of the combined pressures 16 of pushing down from the top and pulling up on the sutures 17 about the bottom of the combined wedges. The lateral 18 portion of the proximal wedge in situ is made up of a set 19 of serrated edges that bite into the bony side of the hole in apposition to it. The top portion of the body of the 21 distal wedge is beveled so as to dig into the bony side of 22 the hole in apposition to it. The medial portion of the 23 proximal wedge in situ has two suture grooves to 24 accommodate suture material threaded through two cylindrical holes in the medial portion of the distal wedge 26 in situ. Suture material is threaded through one of these 27 two cylindrical holes and out through a circular hole in 28 the base of the distal wedge and then through a second 29 circular hole in the base of the distal wedge and up through the body of the distal wedge and out the other of 31 these two cylindrical holes. The base of the distal wedge 32 component in the vicinity of the two holes in the base is 33 inclined so as to prevent contact between suture thread 34 passing from one circular hole to the other and the guide wire emanating from a third hole in the base. The proximal 36 wedge has a round hole through its head and through its WO95/11631 2 1 7 3 ~ 6 9 PCT~S94/12389 1 body running lengthwise that terminates in the inclined 2 medial face in the lower portion of its body. This hole is 3 the hole through which the guide wire component is 4 initially threaded. The medial portion of the distal wedge in situ has as well a hole in it, below the above-described 6 two cylindrical suture holes, for receipt of the guide wire 7 component that exits through the third hole in the base of 8 the distal wedge.
9 The proximal wedge also has a stop face running out at a slightly obtuse angle from the angulation of its inclined 11 medial face. The stop face by ultimately interfacing with 12 a medially located distal wedge stop face prevents the 13 distal wedge from sliding by the proximal wedge and thereby 14 defeating the intended action of the two wedge components of the invention, to wit, permanent anchoring within a hole 16 drilled in bone when upward pressure is applied to the 17 suture thread by pulling the two ends of the thread upwards 18 as downward pressure is applied to the head of the proximal 19 wedge after the tamping down of the two wedges into the drilled hole. Upward pulling causes the stop face located 21 on the medial aspect of the distal wedge to interface with 22 the stop face of the proximal wedge to thereby prevent the 23 distal wedge from sliding too far by the proximal wedge in 24 situ and thereby preventing the desired anchoring within bone.
26 Another embodiment of the instant invention includes a 27 uniquely designed surgical wedge anchor that differs 28 markedly from any other device of a similar nature that has 29 heretofore been known. The wedge in this preferred embodiment has a barbed top portion, three smooth surfaced 31 sides, two suture holes in the somewhat inclined upper 32 portion of the remaining one of its sides that is not 33 smooth surfaced, two laterally positioned suture holes in 34 its base each one connected to one of the two suture holes in the upper portion of its non smooth surfaced side, a 36 first centered hole in the middle of the upper portion of WO95/11631 PCT~S94/12389 ~7 3a~q -6- -l the non-smooth surfaced side which first centered hole is 2 between and below these two suture holes, a centered hole 3 in its base connected to the first described center hole, 4 an inclination in its base so as to minimize drift of suture thread passing from the two lateral holes in the 6 base to the centered hole in the base and ultimately 7 passing through the first centered hole, and finally, a 8 stop face that angulates outwardly from the plane of the 9 upper portion of the wedge's non-smooth surfaced side in which the above described holes are found and that serves ll to separate that side's upper portion from its lower 12 portion inclined in an plane of inclination with direction 13 of inclination similar to the direction of inclination of 14 the plane of inclination of this side's upper portion. The stop face also serves to interface with the inclination in 16 the base of a second wedge when two wedges are utilized for 17 anchoring purposes so as to prevent slippage of one over 18 the other during the end of the anchoring process. The l9 wedge anchor in a third and preferred embodiment reflects all of the features of the second embodiment except that 21 additionally it has a centrally positioned barbed tooth 22 located in an area cut out of the lowest segment of the 23 lower portion of the wedge's non-smooth surfaced side. The 24 wedge anchor in a fourth embodiment resembles the third embodiment but lacks any paired suture holes in either the 26 upper portion of its non-smooth surfaced side or in the 27 inclined portion of the wedge's base. Finally, a fifth 28 embodiment resembles the fourth embodiment but lacks the 29 tooth found in the fourth embodiment. A sixth embodiment wherein there is no inclination in the base of the anchor 3l wedge is yet another useful variant. A seventh embodiment 32 is one that resembles any of the above described 33 embodiments but lacks a stop face. In fact, the above 34 described preferred embodiment without a stop face is an ideal variant for purposes of serving alone as a wedge 36 anchor. One or more of the above described wedges can be 37 utilized to anchor soft tissue to bone by way of suture WO95/11631 2 1 7 3 ~ G 9 PCT~S94/12389 1 threading during surgery or soft tissue to soft tissue by2 way of a suture threading during surgery. Soft tissue 3 connotes either muscle or cartilage or ligaments, for 4 example.
A preferred method of using the second embodiment will 6 now be described. A hole is drilled into bone. Then a 7 hollow insertion tool the base of which is cut at a bias 8 with an outer circumference less than that of the drilled 9 hole within which there is found a hollow plunger the base of which is cut at a bias with outer circumference less in ll measure than that of the perimeter of the lower portion of 12 any embodiment but greater in measurement than the inner 13 circumference of the insertion tool or the circumference of 14 suture thread to be utilized, is resorted to for purposes of introducing one of the preferred embodiments or a 16 plurality of these or one of these in combination with one 17 or more of the other embodiments into the hole to serve as 18 a suture anchor to which soft tissue can be sutured firmly 19 in apposition to such bone. For example, suture thread is passed through the centered holes in the one or more of the 21 latter two embodiments as might be utilized. A knot in the 22 suture thread is tied just below the centered hole in the 23 base of the bottom one of the embodiments to be so 24 utilized. Then the suture material is threaded through the hollow plunger and the plunger together with threaded 26 embodiments are encased within the hollow insertion tool.
27 Then the system is introduced into the hole. Downward 28 pressure is applied to the plunger and this pressure causes 29 the embodiment or embodiments to be so used to be introduced under pressure into the hole in such bone as the 31 insertion tool is simultaneously withdrawn from the hole 32 then, continued downward pressure applied to the plunger 33 coupled with upward pressure on the suture thread causes 34 the wedges to toggle in apposition to one another thus creating an anchor. The barbed tip(s) dig into bone on one 36 side of the hole. The lower tooth (teeth if a plurality of W095/11631 PCT~S94/12389 ~3~q -8-l embodiments some of which are fourth embodiment variants 2 are used) gouge into the other side of the hole by virtue 3 of such applied downward pressure. One toggle wedge, to 4 wit, the preferred embodiment also can be used if not so powerful a suture support is desired. Prior to use of this 6 embodiment and insertion via the method described above, 7 suture thread is run down each of the two upper portion 8 suture holes so that a bridge runs from one hole to the 9 other. Strands exiting suture holes, one per hole in the base are run up the centered hole in the base and out the ll first centered hole. These exiting strands are then run 12 under the thread bridge up and away from the wedge. A
13 plurality of wedges can be used to enhance the sturdiness 14 of the suture support depending upon the particular requirements of the surgical procedure being resorted to.
16 If it is desired to suture soft tissue to soft tissue, 17 then, it would not be necessary to preliminarily drill a 18 hole. The system can be initially prepared as noted above l9 and the insertion tool containing within it, the one or more embodiments tied to suture material and plunger can be 21 introduced into the soft tissue by way of merely piercing 22 the tissue. The shape of the embodiments, the manner of 23 suturing, and if a plurality are used for anchoring, then 24 the base inclination and stop face characteristic all cause anchoring by toggling as previously noted, upward pressure 26 is applied to suture thread along with downward pressure on 27 a plunger.
28 Brief Description of the Drawings 29 Figure l shows the three components of the first embodiment of instant invention, the proximal wedge 31 component, the distal wedge component and the guide wire 32 component in a perspective view.
33 Figure 2 is a frontal view of the proximal wedge 34 component shown in Figure l that is indistinguishable from what would be a posterior view of this component.
36 Figure 3 is a view of the medial side of the proximal WO95/11631 2 t 7 3 8 6 9 PCT~S94/12389 _g_ l wedge component shown in Figure l, in respect of its 2 positioning in situ within a hole drilled in bone.
3 Figure 4 is a view of the lateral side of the proximal 4 wedge component of shown in Figure l in respect of its positioning in situ within a hole drilled in bone.
6 Figure 5 is a longitudinal cross-sectional view of the 7 proximal wedge component shown in Figure l.
8 Figure 6 is a top view of the proximal wedge component 9 of shown in Figure l.
Figure 7 is a perspective view of the proximal wedge ll component shown in Figure l.
12 Figure 8 is a view of the medial side of the distal 13 wedge component shown in Figure l in respect of its 14 positioning in situ within a hole drilled in bone.
Figure 9 is a frontal view of the distal wedge 16 component shown in Figure l that is indistinguishable from 17 what would be a posterior view of this component.
18 Figure lO is a view of the lateral side of the distal 19 wedge component shown in Figure 1 in respect of its positioning in situ within a hole drilled in bone.
21 Figure 11 is a cross-sectional cut away view showing 22 the beveled edge of the top side of the distal wedge 23 component shown in Figure l.
24 Figure 12 is a bottom view of the distal wedge component shown in Figure 1.
26 Figure 13 is a longitudinal cross-sectional view of the 27 distal wedge shown in Figure l.
28 Figure 14 is a perspective view of the medial side of 29 the distal wedge component shown in Figure 1.
Figure 15 shows a cannulated drill bit about to be 31 drilled into bone.
32 Figure 16 shows a cannulated drill bit removed from 33 bone after a hole has been drilled into the bone and the 34 guide wire component of the embodiment of Figure l inserted through the bit into the hole.
36 Figure 17 shows the guide wire component of the WO95tl1631 PCT~S94/12389 ~13~9 -lo-1 embodiment of Figure 1 drawn through the proximal wedge 2 component of the instant invention.
3 Figure 18 shows suture thread through holes in the 4 medial face and bottom of the distal wedge component shown in Figure 1.
6 Figure 19 is a longitudinal cross-sectional view of the 7 proximal and distal wedge components of the embodiment of 8 Figure 1 through which its guide wire component and suture 9 threads have been threaded.
Figure 20 is a perspective view of the proximal wedge 11 component of the embodiment of Figure 1 in apposition to a 12 cut away view of the distal wedge component of said 13 embodiment showing its guide wire component and suture 14 threaded through the same.
Figure 21a is a perspective view of an insertion tool, 16 to wit, a jaw within a sleeve.
17 Figure 21b is a perspective view of an insertion tool, 18 to wit a jaw within a sleeve with the sleeve retracted to 19 permit opening of the jaw closed only under the pressure of an overlapping non-retracted sleeve.
21 Figure 22 is a view of the whole embodiment of Figure 1 22 and suture thread in the presence of an insertion tool with 23 retracted sleeve.
24 Figure 23 is a view of the whole embodiment of Figure 1 and suture thread in the presence of an insertion tool with 26 non-retracted sleeve.
27 Figure 24 is a perspective view of the whole embodiment 28 of Figure 1 and suture thread in the presence of an 29 insertion tool with non-retracted sleeve.
Figure 25 shows the whole embodiment of Figure 2 being 31 inserted into a hole drilled in bone shown in cross-32 sectional view after removal of the drill bit and insertion 33 of its guide wire component.
34 Figure 26 shows the whole embodiment of Figure 1 inserted into a hole drilled in bone shown in cross-36 sectional view subsequent to withdrawal of its guide wire WOg5/11631 2 1 7 3 ~ 6 9 PCT~S94/12389 1 component.
2 Figure 27 shows a dotted facsimile of a surgeons~s left 3 index finger and thumb holding the insertion tool and 4 pushing down on the embodiment of Figure 1 within a hole in bone shown in cross-sectional view and a dotted facsimile 6 of the surgeon's right index finger and thumb pulling up on 7 suture thread.
8 Figure 28 shows a dotted facsimile of a surgeon's left 9 index finger and thumb holding the insertion tool and pushing down on the embodiment of Figure 1 within a hole in 11 bone shown in cross-setional view and a dotted facsimile of 12 the surgeon's right index finger and thumb continuing to 13 pull up on suture thread thereby causing the distal wedge 14 component of the said embodiment in situ to rise against the proximal wedge component thereof.
16 Figure 29 shows the wedge components of the embodiment 17 of Figure 1 firmly in-situ within a hole drilled into bone 18 subsequent to retraction of the insertion tool.
19 Figure 30 is an enlarged view of the wedge components of the embodiment of Figure 1 shown firmly in-situ within a 21 hole drilled into bone with arrows illustrating force 22 vectors outwardly and laterally directed to the sides of 23 the hole.
24 Figure 31 a reduced view of Figure 29 without arrows showing suture thread tied to soft tissue to be held in 26 apposition to the bone.
27 Figure 32 is a plan view of the non-smooth surfaced 28 side of a second embodiment of the instant invention.
29 Figure 33 is a plan view of the top portion of the embodiment of Figure 32.
31 Figure 34 is a plan view of the smooth front side of 32 the embodiment of Figure 32.
33 Figure 35 is a plan view of the smooth side of the 34 embodiment of Figure 32, opposite to the side of the same shown in Fig. 32.
36 Figure 36 is a longitudinal cross-sectional view of the W095/11631 pcTruss4ll2389 2~3~9 -12-embodiment shown. in Figure 32.
2 Figure 37 is a plan view of the base of the second 3 embodiment of the instant invention.
4 Figure 38 is a perspective view of the first embodiment of the second embodiment of the instant invention.
6 Figure 39 is a plan view of the non-smooth surfaced 7 side of a third embodiment of the instant invention.
8 Figure 40 is a plan view of the top portion of the 9 third embodiment of the instant invention.
Figure 41 is a plan view of the smooth front side of 11 the third embodiment of the instant invention.
12 Figure 42 is a plan view of the smooth side of the 13 third embodiment of the instant invention opposite the side 14 of the same shown in Figure 39.
Figure 43 is a longitudinal cross sectional view of the 16 third embodiment of the instant invention.
17 Figure 44 is a plan view of the base of the third 18 embodiment of the instant invention.
19 Figure 45 is a perspective view of the third embodiment of the instant invention.
21 Figure 46 is a plan view of the non-smooth surfaced 22 side of a fourth embodiment of the instant invention.
23 Figure 47 is a plan view of the top portion of the 24 fourth embodiment of the instant invention.
Figure 48 is a plan view of the smooth front side of 26 the fourth embodiment of the instant invention.
27 Figure 49 is a plan view of the smooth side of the 28 fourth embodiment of the instant invention opposite the 29 side of the same shown in Fig. 46.
Figure 50 is a longitudinal cross-sectional view of the 31 fourth embodiment of the instant invention.
32 Figure 51 is a plan view of the base of the fourth 33 embodiment of the instant invention.
34 Figure 52 is a perspective view of the fourth embodiment of the instant invention.
36 Figure 53 is a perspective view of an insertion device 21 7385~
WO95/11631 PCT~S94/12389 1 and plunger device located within the insertion device.
2 Figure 54 is a cross-sectional view of an insertion 3 device and plunger device located within the insertion 4 device.
Figure 55 is a cross-sectional view of the fourth and 6 fifth embodiments of the instant invention held by a piece 7 of suture thread.
8 Figure 56 is a plan view of what is seen in Fig. 55 in 9 apposition to a plunger device an in apposition to an insertion device shown in cross-sectional view.
11 Figure 57 is a plan view of the forth and fifth 12 embodiments of the instant invention held by suture thread 13 in close apposition to a plunger device show cross-14 sectionally within the lumen of an insertion device shown in cross-sectional view.
16 Figure 58 shows an insertion device prior to its 17 piercing a piece of soft tissue. There is also shown, 18 suture material through the top of a plunger device shown 19 within the insertion device.
Figure 59 shown an insertion device having pierced a 21 piece of soft tissue. There is also shown, suture material 22 through the top of a plunger device shown within the 23 insertion device.
24 Figure 60 is an enlarged plan view of the third and fourth embodiments of the instant invention held by suture 26 thread in apposition to a plunger device in cross-sectional 27 view within the lumen of an insertion device shown in 28 cross-sectional view embedded within a piece of soft 29 tissue.
Figure 61 is an isolated enlarged view of the lower 31 portion of an insertion device shown in cross-sectional 32 view embedded in soft tissue material within which are 33 found the plunger device shown in cross-sectional view and 34 part of the fourth embodiment of the instant invention when downward pressure is applied to the plunger device as the 36 insertion device is being withdrawn.

W095/11631 PCT~S94/12389 ~1 3~9 -14-1 Figure 62 is an isolate view of the barbed top portion 2 biting into soft tissue when downward pressure is applied 3 to the plunger device as the insertion device is being 4 withdrawn.
Figure 63 shows the action of the second, third, 6 fourth, and fifth embodiments of the invention in respect 7 biting into tissue as the process referenced in Figure 62 8 is continued.
9 Figure 64 shown the further biting into soft tissue by the second, third, fourth, and fifth embodiments of the ll instant invention as upward pulling pressure is applied to 12 the suture material affixed thereto.
13 Figure 65 is a close-up isolated view of the bite into 14 soft tissue by the centrally positioned barbed tooth of the fourth embodiment of the instant invention.
16 Figure 66 is an isolated view of the resultant 17 anchoring within soft tissue of suture material by virtue 18 of completion of the process described in Fig. 65 above.
19 Figure 67 shows in plan view the manner in which suture thread can be threaded through the holes of the instant 21 invention's third embodiment in contemplation of its being 22 used along as a suture anchoring device.
23 Figure 68 shows suture material threaded as seen in 24 Fig. 67 but in tip plan view.
Figure 69 shows suture material threaded as seen in 26 Fig. 67 but in front plan view.
27 Figure 70 shows in plan view, suture material threaded 28 through suture holes in the inclined base of the instant 29 invention's third embodiment.
Figure 71 is a bottom plan view of what is seen in Fig.
31 70.
32 Figure 72 is a perspective view showing the manner in 33 which suture thread can be threaded through the holes of 34 the instant invention's third embodiment in contemplation of its being used alone as a suture anchoring device.
36 Figure 73 shows in plan view, the third embodiment of WO 95/11631 2 1 73 ~ 6 9 PCT/US94/12389 1 the instant invention about to be inserted into the lumen 2 of an insertion device shown in cross-sectional view.
3 Figure 74 shows in plan view the third embodiment of 4 the instant invention in apposition to a plunger device 5 shown in cross-sectional view within the lumen of an 6 insertion device shown in cross-sectional view.

7 Figure 75 shows downward pressure on a plunger device 8 shown in cross-sectional view concomitant with withdrawal 9 of an insertion device shown in cross-sectional view within a piece of soft tissue and commencement of the toggling of 11 the third embodiment of the instant invention.
12 Figure 76 shows continued downward pressure on a 13 plunger device shown in cross-sectional view concomitant 14 with upward pressure on suture material tied to the third embodiment of the instant invention in furtherence of the 16 toggling of the third embodiment of the instant invention.
17 Figure 77 shows the third embodiment of the instant 18 invention subsequent to completion of the process depicted 19 in Fig. 76 wherein the third embodiment is ready to serve as an anchor within soft tissue.
21 Detailed Description of Preferred Embodiments 22 Figure 1 shows the three components of the first 23 embodiment of the invention, guide wire 13, proximal wedge 24 component 14, and distal wedge component 15 fastened together to thus constitute the whole of this embodiment of 26 the instant invention. Figure 2 shows in frontal view the 27 proximal wedge component 14 of this embodiment of the 28 instant invention. Its cylindrically shaped head 1 is 29 shown as well as its lateral side 2 in terms of how proximal wedge 14 is ultimately positioned as an anchor 31 component within a hole drilled in bone which side 2 is 32 made up of a plurality of serrated edges. Also shown is 33 its stop face 5 extending at an obtuse angle out from the 34 top of its inclined medial face 6 which face 6 is shown in Figure 3 and again in Figure 7. Figure 3 shows two suture 36 grooves 3 and 3a in the medial side of proximal wedge 14, to wit, the side of wedge 14 opposite in position to 2 lateral side 2 once ultimately anchored in bone as well as 3 a guide wire exit hole 4a in the medial face 6 of the 4 proximal wedge. Figure 4 shows lateral side 2 of proximal 5 wedge 14 as well proximal wedge 14's cylindrically shaped 6 head 1. Figure 5 shows lateral side 2, guide wire hole 4 7 and stop face 5 of proximal wedge 14 in a longitudinal 8 cross section view. Figure 6 is a top view of proximal 9 wedge 14 in which there is seen a top view of its 10 cylindrically shaped head 1, guide wire entry hole 4 11 centrally located therein and a top view of proximal wedge 12 14's two identical suture grooves 3 and 3a. Figure 7 is a 13 perspective view of proximal wedge 14 wherein there is 14 shown all of its features as depicted in Figures 2-6 15 inclusive. Figure 8 is a view of the medial side of the 16 distal wedge component 15 of the first embodiment of the 17 instant invention, to wit, that side of distal wedge 15 in 18 apposition to the medial side of proximal wedge 14 once 19 wedges 14 and 15 are firmly anchored in bone. Therein 20 shown are two identical suture entry and re-exit holes 7 21 and 7a respectively as well as a guide wire entry hole 4b 22 and its inclined medial face 11. Figure 9 is a frontal 23 view of distal wedge 15 in which there is seen its beveled 24 top edge 9 and two identical suture exit and re-entry 25 holes, 8 and 8a respectively in the inclined face 12 of its 26 base. Figure 11 is a cross-sectional lateral view showing 27 the beveled top edge 9 of distal wedge 15. It should be 28 noted that the angle of beveling is constant to each of two 29 points in the top edge of distal wedge 15 both equidistant 30 from the center of the top edge from which points the angle 31 of bevel tapers to zero degrees. Figure 12 shows the 32 inclined base face 12 of distal wedge 15 as well as guide 33 wire exit hole 4c and suture exit hole 8 and suture re-34 entry 8a. Figure 13 is a longitudinal cross-sectional view 35 of distal wedge 15 showing its stop face 10, guide wire 36 entry hole 4b, the canal therein leading therefrom to its WO95/11631 2 1 7~869 PCT~S94/12389 1 guide wire exit hole 4c and dotted lines depicting the 2 locus of the canal therein from its suture entry hole 7 to 3 its suture exit hole 8. Figure 14 shows distal wedge 15 in 4 perspective view wherein there is to be seen its suture entry hole 7, its suture re-exit hole 7a, its guide wire 6 entry hole 4b, its stop face 10 and its medial face 11.
7 Figure 15 is a view of a piece of bone E into which a hole 8 is to be drilled with resort a cannulated drill bit A.
9 Once a hole is drilled into bone E, the drill which was used is separated from the cannulated drill bit A and guide 11 wire component 13 is threaded through the canal in drill 12 bit A. Guide wire 13 is threaded down to the base of the 13 drilled hole typically drilled deep enough into bone to 14 pass into deep bone F below the outer cortex E of the bone.
Figure 16 shows in cross-sectional view, bone cortex E and 16 a deeper layer F of bone. The arrow in Figure 16 shows 17 removal to the drill bit A from guide wire 13 after 18 proximal wedge 14 and distal wedge 15 have first been 19 removed therefrom prior to their being repositioned as they would be on guide wire 13 once drill bit A is fully removed 21 therefrom. Figure 17 shows guide wire 13 passing through 22 guide wire entry hole 4 in the cylindrically shaped head 1 23 of proximal wedge 14 and out through its guide wire exit 24 hole 4a. Figure 18 shows suture thread B passing through suture entry hole 7 of distal wedge component 15 and down 26 through the canal between hole 7 and suture exit hole 8 27 from which suture thread B emanates before reentering 28 distal wedge 15 through suture re-entry hole 8a and suture 29 re-exit hole 7a from which it emanates. Figure 19 shows in cross-sectional view, guide wire 13 coursing through guide 31 wire entry hole 4 in head 1 of proximal wedge 14 down 32 through the canal therein leading from hole 4 to guide wire 33 exit hole 4a and into guide wire entry hole 4b in distal 34 wedge 15 and down through the canal therein leading from hole 4b to guide wire exit hole 4c in the base of the 36 distal wedge. There is also to be noted in Figure 19 WO95/11631 PCT~S94/12389 ~1 3~ ~9 -18-1 suture thread B as it would be found passing via suture 2 groove 3a found on the side of proximal wedge 14 opposite 3 the lateral side 2 thereof and into suture entry hole 7 of 4 distal wedge 15 and out suture exit hole 8 thereof. That S which is depicted in Figure 19 is depicted in part in 6 Figure 20 as well. Figure 21A shows an insertion tool with 7 a retractable sleeve C. Figure 21B shows sleeve C of the 8 insertion tool retracted so that its jaw D opens. Figure 9 22 shows guide wire 13 threaded through the insertion tool and proximal wedge 14 and distal wedge 15 and coursing 11 beyond them as it would be leading to the bottom of the 12 previously drilled hole. Figure 23 shows sleeve C of the 13 insertion tool engaged over its jaw D in preparation for 14 pushing down on head 1 of proximal wedge 14. Figure 24 depicts in perspective view what is shown in Figure 23.
16 Figure 25 shows guide wire component 13, proximal wedge 14 17 and distal wedge 15 components of the first embodiment of 18 the instant invention in apposition to the hole previously 19 drilled into bone cortex E wholly circumscribing deeper bone F and the arrow therein shown depicts the direction of 21 its insertion into the bone. Figure 26 shows wedge 22 components 14 and 15 of the first embodiment of the 23 invention after having been pushed with the insertion tool 24 into the hole previously drilled in bone and the arrow therein shown depicts the direction of removal of guide 26 wire 13 once wedge components 14 and 15 are positioned in 27 the hole previously drilled in bone. At this juncture, it 28 should be noted that proximal wedge 14 and distal wedge 15, 29 previously threaded with suture thread B as described above and repositioned on guide wire 13 below an insertion tool 31 after guide wire 13 would have first been threaded through 32 a cannulated drill bit into a hole drilled in bone and the 33 cannulated drill bit removed from the hole and slipped up 34 and off guide wire 13, are ready for permanently wedged insertion into the hole drilled in bone by way of the 36 combined actions of pushing down on the head 1 of proximal ~095/11631 2 1 7 3 8 6 9 PCT/US94/12389 wedge 14 in-situ with the insertion tool while at the same 2 time pulling up on suture thread B. Figure 27 shows the 3 left thumb G and left index finger H of a surgeon pushing 4 down on the head 1 of proximal wedge 14 with the insertion 5 tool with downward force and Figure 27 also shows the right 6 thumb I and right index finger J of the surgeon beginning 7 to pull on the two strands of suture thread B that were 8 previously shown passing through suture entry hole 7 of 9 distal wedge 15 out its suture exit hole 8 passing 10 therefrom along its inclined base face 12 and back through 11 its suture re-entry hole 8a of and up through the distal 12 wedge 15 and out its suture re-exit hole 7a. Inclined base 13 face 12 of distal wedge 15 serves to prevent suture thread 14 B from coming into contact with guide wire 13 as it would 15 be emanating from hole 4c in the base of distal wedge 15.
16 Figure 28 shows the same digits of the same surgeon pushing 17 down with the insertion tool on head 1 of proximal wedge 14 18 and simultaneously pulling on suture thread B. Figure 29 19 shows how the two wedge components 14 and 15 of the first 20 embodiment of the invention are positioned together and 21 firmly anchored within the hole previously drilled in bone 22 once the surgeon has completed the above-described process 23 of pushing and pulling. Figure 30 is a blown up view of 24 the inserted wedge components 14 and 15 of the first 25 embodiment of the instant invention. The arrows M,N and O
26 depict how force emanates laterally against the walling of 27 the hole drilled in bone as a result of downward force L
28 applied to head 1 of proximal wedge 14 being combined with 29 upward force K due to the pulling up on the strands of 30 suture thread B. The combined pushing and pulling causes 31 the plurality of serrated edges of lateral side 2 of 32 proximal wedge 14 to bite firmly into the bone adjacent 33 thereto in view of the resultant upward sliding action of 34 distal wedge 15 against proximal wedge 14 whereby the 35 inclined face 6 of proximal wedge 14 previously in 36 apposition to the medial aspect of distal wedge 15 comes WO95/11631 PCT~S94/12389 ~73~9 -20- -1 into interfaced contact with the inclined face 11 of the 2 distal wedge 15 such that the central diameter of the two 3 wedge components 14 and 15 in apposition to one another is 4 significantly increased. Also, beveled top side 9 of distal wedge 15 cuts into bone in apposition to it in 6 response to such concomitant pushing and pulling to thereby 7 contribute to anchoring and beveled to side 9 together with 8 stop face 5 of proximal wedge 14 and stop face 10 of distal 9 wedge 15 serve to prevent either wedge from sliding by the other during the application of forces L and K to thereby 11 serve to defeat the intended purpose of increasing the 12 central diameter of the two wedge components 14 and 15 in 13 apposition to one another which increasing of the central 14 diameter is what causes the laterally directed biting and cutting described above which in turn is responsible for 16 the permanent positioning in the hole drilled in bone of 17 wedge components 14 and 15 of the invention, to thus result 18 in a firmly and permanently situated suture anchor in bone.
19 Figure 31 shows human or other ~n;m~l soft tissue P held fast to bone by suture thread B tied thereabout such tissue 21 P and concomitantly threaded through and about the distal 22 wedge component 15 of the firmly and permanently situated 23 instant suture anchor.
24 Figure 67 is a plan view of the side of the second preferred embodiment of the instant device that is 26 characterized by the presence of the device's two suture 27 entry holes, hole 101 and hole 102, its suture exit hole 28 103b, its barbed tip 105 located in its top portion and its 29 centrally located lower tooth 106 within a rounded out notch 107 in the lowest part of the lower portion 122 of 31 this side, to wit, of the device's only side that has holes 32 in it. Barbed tip 105 located in the device's top portion 33 serves to pierce into tissue on one side of a pierced 34 insertion hole opposite to the side of the hole bitten into by lower tooth 106 as seen in Figure 77 after the 36 embodiment is threaded as shown with suture material C' and WO95/11631 -21- 2 1 73869 PCT~S94/12389 1 suture material C' is threaded through a hollow plunger B', 2 an example of which is seen in Fig. 73 and then inserted 3 along with plunger B ' into the lumen of insertion device A' 4 as shown in Fig. 74, and then after soft tissue D' is pierced with insertion device A' and then downward pressure 6 is applied to plunger B' as insertion device A' is 7 withdrawn as seen in Fig. 75 followed by continued downward 8 pressure on plunger B' and upward pressure on suture 9 material C' as shown in Fig. 76. Once anchoring in soft tissue Dl is accomplished as shown in Fig. 77, then soft 11 tissue D' is amenable to being sutured to to the soft 12 tissue in close proximity thereto with virtually no fear 13 that the sutured tissues will later come apart due to 14 failure of suturing to hole the tissues together. Fig. 68, Fig. 69, Fig. 70 and Fig. 71 show how suture material C' is 16 threaded through suture entry holes 101 and 102 and down 17 through the body of the embodiment and out through suture 18 exit holes 101b and 102b respectively in the inclined 19 portion of the base 124 of the embodiment and then out ~0 through suture exit hole 103b located in the upper portion 21 120 of the side of this embodiment characterized by the 22 presence of suture entry holes 101 and 102 with hole 103b 23 located between and below holes 101 and 102. The nexus 24 102a between holes 102 and 102b and the nexus 103a between holes 103 and 103b are seen in Fig. 43. Rotation of Fig.
26 43 through an angle of 180 degrees would disclose a 27 separate nexus between holes 101 and 101b equivalent in 28 dimension to that of nexus 102a. It has been noted to be 29 the case that it is singularly important to run the ends of suture material C' exiting hole 103b under the arch or 31 suture material C' formed when suture material C' is 32 initially threaded through holes 101 and 102 in order to 33 m;n;m; ze the toggling effect on the embodiment as suture 34 thread C' is pulled upwards with downward pressure applied to plunger B' as seen in Fig. 76. Fig. 75 shows in 36 perspective view what is depicted in Fig. 67.

WO95/11631 PCT~S94/12389 ~1 3~q -22-1 Figs. 39-45 inclusive excepting Fig. 43 depict the 2 various views of the preferred embodiment of the instant 3 invention as are seen in Fig. 67-72 inclusive but without 4 the suture material C' threaded through the various holes present within the embodiment. Figs. 32-38 inclusive 6 depict various view of another embodiment of the instant 7 invention. This latter embodiment lacks the centrally 8 located lower tooth 106 and notch 107 of the preferred 9 embodiment. This other latter embodiment can be utilized in conjunction with the preferred embodiment, for example, 11 for embedding in bone when one might be seeking to hole a 12 grater tissue load than an anchor made up of only one wedge 13 embodiment, to wit, the preferred embodiment alone. As 14 might be expected, two exemplars of the preferred embodiment could be utilized for purposes of constructing 16 such a relatively stronger anchor. This latter embodiment 17 does not have the overall holding capacity of the preferred 18 embodiment, but, it is somewhat less expensive to 19 manufacture due to its relative simplicity of design.
Figs. 46-52 inclusive depict yet a fourth embodiment of the 21 instant invention. This fourth embodiment is simpler in 22 design than the former two and is less expensive to 23 manufacture. An even simpler embodiment, to wit, the lowe 24 of the two embodiments utilized for anchoring purposes as seen in Fig. 56 and 57 resembles the fourth embodiments but 26 lacks the centrally located lower tooth 106 and notch 107 27 of the third embodiment. These latter two embodiments lack 28 paired lateral suture holes 101 and 102 and paired suture 29 holes lOlb and 102b on the bases of these embodiments and correspondingly lack as well nexus' between holes 101 and 31 lOlb, to wit lOla and between holes 102 and 102b, to with 32 102a. Figs. 53-57 inclusive demonstrate how these latter 33 two embodiments would be tied together with suture material 34 C', placed below plunger B' through which suture material C' would have been threaded and placed in-toto within the 36 lumen of insertion device A'. Device A' is then inserted -23- 21 738~"q into tissue D' as per Figs. 58, 59 and 60. Withdrawal of 2 the device A' coupled with downward pressure on plunger B' 3 constitutes commencement of the process that ultimately 4 causes the wedge system to be toggled wedged into tissue 5 Dl. Barbed tip 105 pierces into tissue D' as seen in Figs.
6 61 and 62. Fig. 63 illustrates the commencement of such 7 toggle anchoring with withdrawal of device A' coupled with 8 downward pressure on plunger B'. Fig. 64 shows completion 9 of toggle anchoring with upward pulling pressure on suture 10 thread C' as plunger B' is concomitantly withdrawn. Fig.
11 65 shows in isolated view, tooth 106 having bitten into 12 tissue D' on the wall of tissue D' opposite to the wall 13 pierced by barbed tip 105. Fig. 66 shows a fully 14 constructed suture anchor with the inclined base of one 15 wedge in apposition to the stop face 104 of a second wedge.
16 The preferred embodiment threaded as shown previously could 17 have been utilized in lieu of the fifth embodiment as shown 18 in Figs. 58 through 66, and for the matter so could have 19 the embodiment shown in Figs. 32-38 inclusive above if 20 threaded as shown in Figs. 67 and 72, but simplicity of 21 design and diminished cost of manufacture would be factors 22 that would, no doubt, prompt use of the fourth and fifth 23 embodiments for purposes of accomplishing sturdy toggle 24 anchoring in tissue in excess of the sturdiness to be 25 appreciated form use of the preferred embodiment alone as 26 per the protocol evidenced with respect to Figs. 73-77 27 inclusive. The preferred embodiment and its less expensive 28 counterpart, to wit, the embodiment shown in Figs. 32-38 29 could however be used in tandem to accomplish extra sturdy 30 anchoring in bone.

Claims (15)

1. A suture anchor for securing a suture (B) to a bore hole in a bone (E,F), and comprising:
a. a distal wedge (15) for being removably mounted on a guide wire (13), said distal wedge including holes (7,7a,8,8a) for receiving said suture ; and b. a proximal wedge (14) for being removably mounted on said guide wire, said proximal wedge including grooves (3,3a) for receiving said suture received through said holes of said distal wedge;
and wherein, said wedges include means (2,5,9,10) for laterally anchoring said anchor into said bone upon application of upwardly acting force (K) to said distal wedge and downwardly acting force (L) to said proximal wedge.
2. A suture anchor according to claim 1, wherein said distal wedge (15) includes a beveled portion (9) for digging into said bone.
3. A suture anchor according to claim 1, wherein said lateral anchoring means includes a plurality of serrated edges (2) on a lateral portion of said proximal wedge.
4. A suture anchor according to claim 1, wherein said wedges include stop faces (5,10) adapted to mitigate sliding of said wedges over one another upon application of said forces.
5. A suture anchor according to claim 1, wherein said wedges comprise mounting holes (4,4a,4b,4c) for receiving said guide wire, whereby to mount said wedges of said guide wire.
6. A suture anchor according to claim 1, wherein said holes for receiving suture thread comprise two holes (7,7a) in a medial portion (11) of said distal wedge and two holes, (8,8a) in a base portion (12) of said distal wedge, said holes communicating with each other through said distal wedge.
7. A suture anchor according to claim 6, wherein said base portion (12) of said distal wedge is wedge-shaped.
8. A suture anchor, and comprising, an upper (120) and lower (122) portion, said upper and lower portions including means (105,106) for piercing into body tissue (D'), and a plurality of holes (101,102,101b,102b,103,103b) for receiving suture thread (C'), said holes being located in both said upper and lower portions, at least some of said holes being connected together so as to permit said thread to be channeled through said anchor for attaching to said anchor whereby to permit said thread to be secured to said body tissue (D').
9. A suture anchor according to claim 8, wherein said anchor is wedge-shaped.
10. A suture anchor according to claim 8, wherein said anchor includes a barbed top portion (105).
11. A suture anchor according to claim 8, wherein said plurality of holes includes:
i. two suture holes (101,102) in said upper portion;
ii. two laterally positioned suture holes (101B,102B) in a base portion of said body, one of said laterally positioned holes being connected to one of said holes in said upper portion, the other of said laterally positioned holes being connected to the other of said holes in said upper portion;
iii. a first centered hole (103B) between and below the suture holes in the upper portion; and iv. a second centered hole (103) in said base portion and connected to said first centered hole.
12. A suture anchor according to claim 8, wherein said anchor includes an angled base portion (106,107).
13. A suture anchor according to claim 8, and further comprising, a centrally positioned barbed tooth (106).
14. A suture anchor according to claim 13, wherein said barbed tooth (106) includes a notch (107).
15. A suture anchor according to claim 14, wherein said plurality of holes includes:
i. a first centered hole (103B) between and below the suture holes in the upper portion; and ii. a second centered hole (103) in a base portion of said body and connected to said first centered hole.
CA 2173869 1993-10-28 1994-10-28 A suture anchor Abandoned CA2173869A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US08/142,058 1993-10-28
US08142058 US5324308A (en) 1993-10-28 1993-10-28 Suture anchor
US08/235,345 1994-04-29
US08235345 US5405359A (en) 1994-04-29 1994-04-29 Toggle wedge

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CA2173869A1 true true CA2173869A1 (en) 1995-05-04

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JP (1) JPH09504216A (en)
CA (1) CA2173869A1 (en)
WO (1) WO1995011631A1 (en)

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WO1995011631A1 (en) 1995-05-04 application
JPH09504216A (en) 1997-04-28 application

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