Language selection

Search

Patent 2173869 Summary

Third-party information liability

Some of the information on this Web page has been provided by external sources. The Government of Canada is not responsible for the accuracy, reliability or currency of the information supplied by external sources. Users wishing to rely upon this information should consult directly with the source of the information. Content provided by external sources is not subject to official languages, privacy and accessibility requirements.

Claims and Abstract availability

Any discrepancies in the text and image of the Claims and Abstract are due to differing posting times. Text of the Claims and Abstract are posted:

  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent Application: (11) CA 2173869
(54) English Title: A SUTURE ANCHOR
(54) French Title: ELEMENT D'ANCRAGE DE SUTURE
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 17/68 (2006.01)
  • A61B 17/04 (2006.01)
  • A61B 17/16 (2006.01)
  • A61F 2/08 (2006.01)
(72) Inventors :
  • PIERCE, JAVIN (United States of America)
(73) Owners :
  • PIERCE, JAVIN (United States of America)
(71) Applicants :
  • PIERCE, JAVIN (United States of America)
(74) Agent: GOWLING LAFLEUR HENDERSON LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 1994-10-28
(87) Open to Public Inspection: 1995-05-04
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1994/012389
(87) International Publication Number: WO1995/011631
(85) National Entry: 1996-04-10

(30) Application Priority Data:
Application No. Country/Territory Date
08/142,058 United States of America 1993-10-28
08/235,345 United States of America 1994-04-29

Abstracts

English 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).


French Abstract

Selon un mode de réalisation, l'invention est composée d'un fil de guidage (13), d'un coin de blocage proximal (14) et d'un coin de blocage distal (15). Selon un second mode préféré de réalisation, un coin d'ancrage chirurgical de conception unique est décrit, lequel comporte une partie supérieure (105) garnie d'une pointe, une pluralité de trous de suture (101, 102, 101b, 102b, 103, 103b), ainsi qu'une dent inférieure (106) placée au centre d'une encoche arrondie dans la partie la plus basse (122) de l'élément.

Claims

Note: Claims are shown in the official language in which they were submitted.




-24-

CLAIMS

What is claimed is:
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.




-25-


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




-26-


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.

Description

Note: Descriptions are shown in the official language in which they were submitted.


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




2 A SUTURE ANCHOR
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.
18
19 Title Issue
20 Inventor(s) Invention U.S.Patent No. Date
21
22 Goble et al Harpoon Suture 5,141,520 8/25/92
23 Anchor
24
Gatturna et al Suture Anchor 4,898,156 2/6/90
26
27 Chow Surgical 5,176,682 1/5/93
28 Implement
29
Anspach, Jr. Suture Anchor 5,102,421 4/7/92
31 and Method of
32 Forming
33
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
38
39 Hayhurst et al Bone Anchor and 5,037,422 8/6/91
Method of
41 Anchoring a
42 Suture to a Bone
43
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~
WO 95/11631 PCT/US94/123X9
--3--

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
-7-


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
-13-

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
--15--

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,

W095/11631 PCT/US94112389
9 -16-

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
-17-

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

WO 9S/11631 PCT/US94112389
-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.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 1994-10-28
(87) PCT Publication Date 1995-05-04
(85) National Entry 1996-04-10
Dead Application 1997-10-28

Abandonment History

Abandonment Date Reason Reinstatement Date
1996-10-28 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1996-04-10
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
PIERCE, JAVIN
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

To view selected files, please enter reCAPTCHA code :



To view images, click a link in the Document Description column. To download the documents, select one or more checkboxes in the first column and then click the "Download Selected in PDF format (Zip Archive)" or the "Download Selected as Single PDF" button.

List of published and non-published patent-specific documents on the CPD .

If you have any difficulty accessing content, you can call the Client Service Centre at 1-866-997-1936 or send them an e-mail at CIPO Client Service Centre.


Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Cover Page 1996-07-17 1 16
Abstract 1995-05-04 1 38
Description 1995-05-04 23 1,192
Representative Drawing 1997-06-17 1 4
Claims 1995-05-04 3 106
Drawings 1995-05-04 17 566
International Preliminary Examination Report 1996-04-10 10 344