WO1998030141B1 - Devices for tissue repair and methods for preparation and use thereof - Google Patents
Devices for tissue repair and methods for preparation and use thereofInfo
- Publication number
- WO1998030141B1 WO1998030141B1 PCT/US1998/000414 US9800414W WO9830141B1 WO 1998030141 B1 WO1998030141 B1 WO 1998030141B1 US 9800414 W US9800414 W US 9800414W WO 9830141 B1 WO9830141 B1 WO 9830141B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- implant
- tissue
- implant body
- load
- biocompatible polymer
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract 6
- 230000017423 tissue regeneration Effects 0.000 title claims abstract 3
- 239000007943 implant Substances 0.000 claims abstract 87
- 229920000249 biocompatible polymer Polymers 0.000 claims abstract 11
- 239000000463 material Substances 0.000 claims abstract 3
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 239000003431 cross linking reagent Substances 0.000 claims 9
- 239000002245 particle Substances 0.000 claims 6
- -1 poly(lactic acid) Polymers 0.000 claims 5
- 229920001223 polyethylene glycol Polymers 0.000 claims 4
- 102000008186 Collagen Human genes 0.000 claims 3
- 108010035532 Collagen Proteins 0.000 claims 3
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims 3
- 150000001299 aldehydes Chemical class 0.000 claims 3
- 229920001436 collagen Polymers 0.000 claims 3
- 229920001477 hydrophilic polymer Polymers 0.000 claims 3
- 238000011065 in-situ storage Methods 0.000 claims 3
- 239000011236 particulate material Substances 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims 2
- 239000002202 Polyethylene glycol Substances 0.000 claims 2
- 239000013543 active substance Substances 0.000 claims 2
- 239000001506 calcium phosphate Substances 0.000 claims 2
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims 2
- 239000000919 ceramic Substances 0.000 claims 2
- 238000004132 cross linking Methods 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 239000003102 growth factor Substances 0.000 claims 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims 2
- 239000011159 matrix material Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims 2
- 239000011541 reaction mixture Substances 0.000 claims 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 2
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims 2
- 235000019731 tricalcium phosphate Nutrition 0.000 claims 2
- 229940078499 tricalcium phosphate Drugs 0.000 claims 2
- 229920000954 Polyglycolide Polymers 0.000 claims 1
- 102000009618 Transforming Growth Factors Human genes 0.000 claims 1
- 108010009583 Transforming Growth Factors Proteins 0.000 claims 1
- 238000004873 anchoring Methods 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 239000004068 calcium phosphate ceramic Substances 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 102000013373 fibrillar collagen Human genes 0.000 claims 1
- 108060002894 fibrillar collagen Proteins 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000005304 joining Methods 0.000 claims 1
- 229910052751 metal Inorganic materials 0.000 claims 1
- 239000002184 metal Substances 0.000 claims 1
- 229920000747 poly(lactic acid) Polymers 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims 1
- 239000004810 polytetrafluoroethylene Substances 0.000 claims 1
- 210000000513 rotator cuff Anatomy 0.000 claims 1
- HBMJWWWQQXIZIP-UHFFFAOYSA-N silicon carbide Chemical compound [Si+]#[C-] HBMJWWWQQXIZIP-UHFFFAOYSA-N 0.000 claims 1
- 229910010271 silicon carbide Inorganic materials 0.000 claims 1
- 229920002379 silicone rubber Polymers 0.000 claims 1
- 239000004945 silicone rubber Substances 0.000 claims 1
- 238000003780 insertion Methods 0.000 abstract 1
- 230000037431 insertion Effects 0.000 abstract 1
- 230000008961 swelling Effects 0.000 abstract 1
Abstract
Disclosed herein are uniformly shaped swellable devices comprising polymeric materials, as well as apparatuses and processes for their manufacture. In one embodiment, the present invention relates to load bearing implant devices for use in tissue repair. The implants consist of a resorbable, swellable implant body which is formed from a dehydrated cross-linked biocompatible polymer. As such, the implants are capable of swelling after insertion to become anchored in place. The implants function to enhance the structural integrity of the hard tissue into which they are placed, and thereby improve the load bearing capacity of such tissues. The implants are particularly well suited for use in attaching a second (hard or soft) tissue to the first (hard) tissue into which the implant is inserted. They may also be used as a site for attachment of a surgical device such as a screw, rod or pin.
Claims
1. A load bearing hard tissue implant comprising a resorbable, swellable implant body, wherein said implant body comprises a dehydrated crosslinked biocompatible polymer.
2. The implant of claim 1, wherein the implant body has a length and a width.
3. The implant of claim 2, wherein the length of the implant body is greater than the width.
4. The implant of claim 2, wherein the implant body contains at least one hollow channel adapted to receive at least one suture.
5. The implant of claim 1 further comprising a load-distributing device adapted to hold a suture.
6. The implant of claim 5, wherein the load-distributing device comprises a biodegradable material.
7. The implant of claim 1 , wherein the implant body is cylindrical.
8. The implant of claim 1 , wherein the biocompatible polymer is crosslinked with an aldehyde-containing crosslinking agent.
9. The implant of claim 8, wherein the aldehyde-containing crosslinking agent is selected from the group consisting of glutaraldehyde and formaldehyde.
10. The implant of claim 9, wherein the aldehyde-containing crosslinking agent is glutaraldehyde.
11. The implant of claim 1 , wherein the crosslinking agent is a functionally activated synthetic hydrophilic polymer.
12. The implant of claim 1 , wherein the crosslinking agent is a mixture of a functionally activated synthetic hydrophilic polymer and an aldehyde- containing crosslinking agent.
13. The implant of claim 1 1 , wherein the functionally activated synthetic hydrophilic polymer is a muhifunctionally activated polyethylene glycol.
58
14. The implant of claim 13, wherein the muhifunctionally activated polyethylene glycol is selected from the group consisting of SG-PEG and SE- PEG.
15. The implant of claim 1 , wherein the biocompatible polymer is noncovalently crosslinked.
16. The implant of claim 15, wherein crosslinking is achieved using a method comprising a step selected from the group consisting of: drying, irradiation, heating and compression.
17. The implant of claim 1 , wherein the biocompatible polymer is collagen.
18. The implant of claim 15, wherein the collagen is fibrillar collagen.
19. The implant of either of claims 17 or 18, wherein the implant body contains at least one hollow channel adapted to receive at least one suture.
20. The implant of claim 19 further comprising a load-distributing device adapted to hold a suture.
21. The implant of claim 20 where said load-distributing device is made of a non-resorbable material.
22. The implant of claim 21 wherein said load-distributing device is made of medical grade ceramic.
23. The implant of claim 21 wherein said load -distributing device is made of medical grade polymer.
24. The implant of claim 21 wherein said load -distributing device is made of medical grade metal.
25. The implant of claim 1 , wherein the implant body further comprises a particulate material.
26. The implant of claim 25, wherein the particulate material is selected from the group consisting of: particulate collagen, poly(lactic acid), poly(glycolic acid), polytetrafluoroethylene, silicone rubber, calcium carbonate, calcium sulfate, and silicon carbide.
27. The implant of claim 25, wherein the particulate material comprises calcium phosphate ceramic particles.
59
28. The implant of claim 27, wherein the ceramic particles are selected from the group consisting of: tricalcium phosphate particles, hydroxyapatite particles, and a mixture of tricalcium phosphate particles and hydroxyapatite particles.
29. The implant of claim 1 , wherein the implant body further comprises an effective amount of one or more biologically active agents.
30. The implant of claim 29, wherein the biologically active agent comprises a growth factor.
31. The implant of claim 30, wherein at least one of the growth factor is a member of the transforming growth factor supergene family.
32. The implant of claim 2, wherein the implant body has an outer surface, and wherein the outer surface is textured.
33. The implant of claim 32, wherein the outer surface of the implant body is ribbed.
34. The implant of claim 32, wherein the outer surface of the implant body has three or more ribs running the entire length of the implant body.
35. The implant of claim 32, wherein the outer surface of the implant body has eight ribs running the entire length of the implant body.
36. The implant of claim 2 for use in repairing a rotator cuff, wherein the average width of the implant body is between about 1.0 to about 6.0 mm. and wherein the average length of the implant body is between about 3.0 and about 30 mm in length.
37. The implant of claim 33, wherein the average width of the implant body is between about 2.0 and about 5.0 mm, and the average length of the implant body is between about 8.0 mm and about 18.0 mm.
38. The implant of claim 34, wherein the average width of the implant body is between about 2.5 and about 4.5 mm in diameter, and the average length of the implant body is between about 8.0 mm and about 18.0 mm.
39. A process for preparing an implant body for use in a load bearing implant device for hard tissue repair in the body of a mammalian subject, comprising the steps:
60
(a) mixing together a biocompatible polymer with a crosslinking agent to form a reaction mixture;
(b) introducing the reaction mixture into a mold having a desired shape before substantial crosslinking has occurred between the biocompatible polymer and the crosslinking agent;
(c) allowing the biocompatible polymer and the crosslinking agent to react within the mold to form a matrix;
(d) drying the matrix to form a dehydrated implant body.
40. A method for joining a second tissue to a first tissue in a body of a mammalian subject, wherein the first tissue is a hard tissue, comprising the steps:
(a) forming a cavity in the first tissue;
(b) inserting a load bearing implant into the cavity, wherein the implant comprises:
(i) a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer; and
(ii) a load-distributing device adapted to hold a suture;
(c) allowing the implant body to rehydrate in situ to anchor the implant into the first tissue; and
(d) attaching a second tissue to the implant using the suture.
41. A method for anchoring a surgical device into a hard tissue, comprising the steps of:
(a) forming a cavity in the hard tissue;
(b) inserting a load bearing implant into the cavity, wherein the implant comprises a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer;
(c) inserting the surgical device into the implant; and
(d) before or after step (c), allowing the implant body to rehydrate in situ to anchor the implant into the hard tissue.
42. A method for securing a second tissue to a first tissue in a body of a mammalian subject, wherein the first and second tissues are hard tissues, comprising the steps of:
(a) inserting at least one load bearing implant into said hard tissues, such that each load bearing implant transverses both of said hard tissues, wherein the load bearing implant comprises a resorbable, swellable implant body comprising a dehydrated crosslinked biocompatible polymer; and
(b) allowing the implant body to rehydrate in situ to anchor the implant into the first and second tissues.
62
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU60198/98A AU6019898A (en) | 1997-01-09 | 1998-01-08 | Devices for tissue repair and methods for preparation and use thereof |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US78101297A | 1997-01-09 | 1997-01-09 | |
| US08/781,012 | 1997-01-09 | ||
| US83387497A | 1997-04-10 | 1997-04-10 | |
| US08/833,874 | 1997-04-10 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| WO1998030141A2 WO1998030141A2 (en) | 1998-07-16 |
| WO1998030141A3 WO1998030141A3 (en) | 1998-11-26 |
| WO1998030141B1 true WO1998030141B1 (en) | 1999-02-11 |
Family
ID=27119788
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1998/000414 WO1998030141A2 (en) | 1997-01-09 | 1998-01-08 | Devices for tissue repair and methods for preparation and use thereof |
| PCT/US1998/000530 WO1998030252A1 (en) | 1997-01-09 | 1998-01-08 | Methods and apparatuses for making swellable uniformly shaped devices from polymeric materials |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1998/000530 WO1998030252A1 (en) | 1997-01-09 | 1998-01-08 | Methods and apparatuses for making swellable uniformly shaped devices from polymeric materials |
Country Status (3)
| Country | Link |
|---|---|
| US (2) | US6083522A (en) |
| AU (2) | AU6019898A (en) |
| WO (2) | WO1998030141A2 (en) |
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1998
- 1998-01-08 WO PCT/US1998/000414 patent/WO1998030141A2/en active Application Filing
- 1998-01-08 US US09/004,550 patent/US6083522A/en not_active Expired - Lifetime
- 1998-01-08 AU AU60198/98A patent/AU6019898A/en not_active Abandoned
- 1998-01-08 AU AU60215/98A patent/AU6021598A/en not_active Abandoned
- 1998-01-08 WO PCT/US1998/000530 patent/WO1998030252A1/en active Application Filing
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1999
- 1999-07-27 US US09/362,124 patent/US6280474B1/en not_active Expired - Lifetime
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