CA2332020C - Bone augmentation device - Google Patents

Bone augmentation device Download PDF

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Publication number
CA2332020C
CA2332020C CA002332020A CA2332020A CA2332020C CA 2332020 C CA2332020 C CA 2332020C CA 002332020 A CA002332020 A CA 002332020A CA 2332020 A CA2332020 A CA 2332020A CA 2332020 C CA2332020 C CA 2332020C
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CA
Canada
Prior art keywords
plate
curvature
range
bone
hole
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002332020A
Other languages
French (fr)
Other versions
CA2332020A1 (en
Inventor
Raymond Curtis
Markus Hehli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes USA LLC
Original Assignee
Synthes USA LLC
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
Application filed by Synthes USA LLC filed Critical Synthes USA LLC
Publication of CA2332020A1 publication Critical patent/CA2332020A1/en
Application granted granted Critical
Publication of CA2332020C publication Critical patent/CA2332020C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • 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
    • A61B2017/0404Buttons
    • 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
    • A61B2017/0446Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0459Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
    • 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

The bone augmentation device is used for attachment of soft tissues to bone by means of sutures. It comprises a curved bone plate (1) with several through holes (2). The bone plate (1) lies in a curved plane (3) having a curvature R PL, in the range of 25 to 100 mm. The edges (4) of the plate (1) are rounded with a curvature R EP in the range of 0,2 to 0,7 mm and the edges (5) of the through holes (2) are rounded with a curvature R EH in the range of 0,2 to 0,8 mm. The device according to the invention prevents the suture from cutting through the bone and prevents gapping between the soft tissue (tendon) and bone which would result in a poor healing. The consequence is that a stable repair will facilitate healing.

Description

Hone augmentation device This invention concerns a bone augmentation device in accordance with the pre-characterising portion of Claim 1.
Such bone augmentation devices are used for attachment of soft tissues to bone by means of commonly used sutures. Attachment of soft tissue to bone is a technique frequently required in orthopaedic surgical procedures. It is used in repair of soft tissue avulsions from bone as well as in reconstructive procedures. Augmentation devices are used in. particular for attachment of avulsed tendons, ligaments and joint capsules to bone.
They are indicated for the following fields of application:
A) shoulder instability and rotator cuff tears The shoulder is dislocated more frequently than any other human joint causing limitation of motion and pain in athletes and nonathletes of all ages.
B) knee instability C) tenodosis and licramentous repair of the foot, ankle and wrist One state of the art procedure of soft tissue attachment to bone is the classic Bankart procedure which is a widely accepted method of treating anterior-inferior gleno-humeral instability of the shoulder. It uses sutures that are inserted directly through transosseous tunnels. Although the surgical exposure involves minimal trauma and skin incision and leads to excellent clinical results with reported recurrence rate of only 3,5 to 4,0 ~ , the procedure of reattaching the torn ligament or tendon can be time consuming and difficult. While modifications that decrease the operating time for standard rotator cuff and Bankart lesion repair are available, these approaches are technically demanding.
Another known method for soft tissue attachment to bone is the use of surgical staples which, however, have a tendency to cut through the bone and tendon.
The invention as claimed aims at solving the above described problems.
The present invention provides a bone augmentation device as defined in Claim 1. The device according to the invention prevents the suture from cutting through the bone and prevents gapping between the soft tissue (tendon) and bone which would result in a poor healing. The consequence is that a stable repair will facilitate healing.
The device according. to the invention consists of a perforated curved plate having a curvature RpL in the range of 25 to 100 mm. For application to the humerus the curvature RpL should be in the range of 35 to 70 mm, preferably in the range of 45 to 55 mm.
In order to prevent damage of the suture at the edges of the plate the edges at the outer periphery of the plate are rounded with a curvature REp in the range of 0,2 to 0,7.mm and the edges of the through holes are rounded with a. curvature REH in the range of 0,2 to 0,8 mm.
The curvature REp of the peripheral edges purposefully is chosen in the range of 0,25 to 0,50 mm and preferably in the range of 0,3 to 0,4 mm. The curvature REH of the edges of the through holes purposefully is chosen in the range of 0,30 to 0,50 mm and preferably in the range of 0,35 to 0,45 mm.
The maximum thickness (6) of the plate is below 1 mm and preferably below 0,75 mm. The maximum convex surface area F of the plate -including the area of the through holes - should be in the range of 100 - 250 mm2, preferably in the range of 125 - 175 mm2.
The device according to the invention needs at least one through hole and preferably at least two through holes. For many applications 4 to 7 through holes are ideal. The through holes should have a diameter in the range of 1,70 to 2,00 mm and preferably in the range of 1,80 to 1,90 mm. The minimum distance between two centres of the through holes is in the range of 3,0 to 4,3 mm and preferably in the range of 3,4 to 3,8 mm.
The device may be made of any recognised implant material but titanium is preferred because it can withstand higher loads compared to plastic materials. Alternatively titanium offers the possiblity to design plates with reduced height.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming part of this disclosure. For the better understanding of the invention, its operating advantages and specific objects attained by its use, reference should be had to the accompanying drawings, examples and descriptive matter in which are illustrated and described preferred embodiments of the invention.
In the drawings:
Fig. 1 is a top view of the device according to the invention;
Fig. 2 is a section along line II-II of Fig. 1; and Fig. 3 is a section along line III-III of Fig. 1.

Figures 1 to 3 show a bone augmentation device for attachment of soft tissues to bone by means of sutures consisting of a curved plate 1 wholly made of titanium with a thickness of 0,7 mm. The plate 1 is provided with seven through holes 2 with a diameter of 1,85 mm and whose centres are regularly spaced at 3,6 mm from each other.
The plate 1 lies in a curved plane 3 having a curvature RpL of 50 mm. The outer edges 4 of the plate Z are rounded with a curvature REp of 0,35 mm and the edges 5 of the through holes 2 are also rounded with a curvature REH of 0,4 mm.
The plate 1 has a maximum convex surface area F - including the area of the through holes 2 - of approximately 150 mm~.
Following is a short description of the method of operation with the device according to the invention.
First the tendon attachment site is selected by the surgeon.
Using a burr, a trough which will later receive the tendon stump is selected. Holes are created in the bone at the desired attachment site. Suture stitches are created in the tendon, the end of the sutures are passed through the holes in the bone. The sutures are passed through the appropriate holes of the augmentation device. As the knots are tied the avulsed tendon and augmentation device are pulled onto the bone. the resulting repair is very stable and does not allow gapping between the end of the tendon and bone.

While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be obvious for those skilled in the art that various changes and modifications may be made therein without departing from the true spirit and scope of the present invention.

Claims (35)

1. Bone augmentation device for attachment of soft tissues to bone by means of sutures, comprising a curved bone plate (1) with rounded edges (4), having a maximum thickness (6), and with at least a first through hole (2), characterized in that A) the bone plate (1) lies in a curved plane (3) having a curvature R PL in the range of 25 to 100 mm;
B) the rounded edges (4) of the plate (1) have a curvature R EP in the range of 0,2 to 0,7 mm;
C) the edge (5) of the first through hole (2) is rounded with a curvature R EH in the range of 0,2 to 0, 8 mm; and D) the bone plate (1) is made of a non-resorbable implant material.
2. Device according to claim 1, characterized in that the curvature R PL of plane (3) is in the range of 35 to 70 mm.
3. Device according to claim 1 or 2, characterized in that the curvature R EP of the edges (4) is in the range of 0,25 to 0,50 mm.
4. Device according to one of the claims 1 to 3, characterized in that the curvature R EH of the edge (5) is in the range of 0,30 to 0,50 mm.
5. Device according to one of the claims 1 to 4, characterized in that the maximum thickness (6) of the plate is below 1 mm.
6. Device according to one of the claims 1 to 5, characterized in that the plate (1) has a maximum convex surface area F including the area of at least a first through hole (2) in the range of 100 - 250 mm2.
7. Device according to one of the claims 1 to 6, characterized in that the plate (1) further comprises a second through hole (2).
8. Device according to claim 7, characterized in that the first and second through holes (2) have a diameter in the range of 1,70 to 2,00 mm.
9. Device according to one of the claims 7 or 8, characterized in that the minimum distance between the centres of the first and second through holes (2) is in the range of 3,0 - 4,3 mm.
10. Device according to one of the claims 1 to 9, characterized in that it is made wholly from titanium.
11. Device according to claim 2, characterized in that the curvature R PL of plane (3) is in the range of 45 to 55 mm.
12. Device according to claim 3, characterized in that the curvature R EP of the edges (4) is in the range of 0,3 to 0,4 mm.
13. Device according to claim 4, characterized in that the curvature R EP of the edges (4) is in the range of 0,35 to 0,45 mm.
14. Device according to claim 5, characterized in that the maximum thickness (6) of the plate is below 0, 75 mm.
15. Device according to claim 6, characterized in that the plate (1) has a maximum convex surface area F including the area of at least a first through hole (2) in the range of 125 - 175 mm2.
16. Device according to claim 7, characterized in that the plate (1) comprises 4 to 7 through holes (2).
17. Device according to claim 8, characterized in that the first and second through holes (2) have a diameter in the range of 1,8 to 1,9 mm.
18. Device according to claim 9, characterized in that the minimum distance between the centres of the first and second through holes (2) is in the range of 3,4 to 3,8 mm.
19. A bone augmentation device for attachment of soft tissue to bone by sutures, comprising:
a bone plate having a central plane and top and bottom surfaces spaced equidistant from the central plane and defining at least one through hole extending between the top and bottom surfaces, the central plane including a longitudinal axis and a horizontal axis, wherein the plate is preformed to conform to bone and is curved along the longitudinal and horizontal axes and has a radius of curvature between about 25 and 100 mm, and the plate is made of a non-resorbable material.
20. The device of claim 19, wherein the plate has a radius of curvature between about 35 and 70 mm.
21. The device of claim 20, wherein the plate has a radius of curvature between about 45 and 55 mm.
22. The device of claim 19, wherein the plate defines hole edges at the intersection of the at least one through hole with the top and bottom surfaces and the hole edges are rounded with a radius of curvature between about 0,2 and 0,8 mm.
23. The device of claim 22, wherein the radius of curvature of the hole edges is between about 0,25 and 0,50 mm.
24. The device of claim 19, wherein the plate defines outer edges along the periphery of the top and bottom surfaces and the outer edges are rounded with a radius of curvature between about 0,2 and 0,7 mm.
25. The device of claim 24, wherein the radius of curvature of the outer edges is between about 0,30 and 0,50 mm.
26. The device of claim 19, wherein the plate has a thickness defined between the top and bottom surfaces and the thickness is less than 1 mm.
27. The device of claim 19, wherein the thickness is less than 0,75 mm.
28. The device of claim 26, wherein the top and bottom surface have a surface area between about 100 and 250 mm2.
29. The device of claim 28, wherein the top and bottom surface have a surface area between about 125 and 175 mm2.
30. The device of claim 19, wherein the plate has at least two through holes.
31. The device of claim 30, wherein the plate has between 4 and 7 through holes.
32. The device of claim 30, wherein the through holes include a centre and the distance between the centres is between about 3,0 and 4,3 mm.
33. The device of claim 19, wherein the at least one through hole has a diameter between about 1,70 and 2,00 mm.
34. The device of claim 19, wherein the at least one through hole has a diameter between about 1,80 and 1,90 mm.
35. The device of claim 19, wherein the plate is made from titanium.
CA002332020A 1998-05-12 1998-05-12 Bone augmentation device Expired - Fee Related CA2332020C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP1998/002761 WO1999058073A1 (en) 1998-05-12 1998-05-12 Bone augmentation device

Publications (2)

Publication Number Publication Date
CA2332020A1 CA2332020A1 (en) 1999-11-18
CA2332020C true CA2332020C (en) 2006-12-05

Family

ID=8166955

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002332020A Expired - Fee Related CA2332020C (en) 1998-05-12 1998-05-12 Bone augmentation device

Country Status (11)

Country Link
US (1) US6344042B1 (en)
EP (1) EP1077652B1 (en)
JP (1) JP4193964B2 (en)
AR (1) AR016476A1 (en)
AT (1) ATE247427T1 (en)
AU (1) AU733432B2 (en)
CA (1) CA2332020C (en)
DE (1) DE69817405T2 (en)
DK (1) DK1077652T3 (en)
ES (1) ES2205513T3 (en)
WO (1) WO1999058073A1 (en)

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Also Published As

Publication number Publication date
DE69817405T2 (en) 2004-06-24
ATE247427T1 (en) 2003-09-15
EP1077652A1 (en) 2001-02-28
ES2205513T3 (en) 2004-05-01
EP1077652B1 (en) 2003-08-20
WO1999058073A1 (en) 1999-11-18
AU8103898A (en) 1999-11-29
DE69817405D1 (en) 2003-09-25
AU733432B2 (en) 2001-05-17
JP2002514462A (en) 2002-05-21
JP4193964B2 (en) 2008-12-10
DK1077652T3 (en) 2003-11-10
CA2332020A1 (en) 1999-11-18
US6344042B1 (en) 2002-02-05
AR016476A1 (en) 2001-07-04

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