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US6083522A
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US
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Devices for tissue repair and methods for preparation and use thereof
Assignee: Surgical Specialties Corp Ltd
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Filing: 1998-01-08
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Granted: 2000-07-04
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Expires: 2018-01-08
Abstract
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 crosslinked 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.
Inventors
- 👤 George H. Chu
- 👤 Jeff E. Yeung
- 👤 Jacqueline Anne Schroeder
- 👤 Vivek N. Shenoy
- 👤 Melissa K. C. Brown
- 👤 James J. Cassidy
- 👤 John Rice
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-29 05:17
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/04; A61B17/0401; A61L; A61L27/00; A61L27/14; A61L27/22; A61L27/24; A61L27/40; A61L27/44; A61L27/46; A61L27/48; A61L31/00; A61L31/04; A61L31/043; A61L31/044; A61L31/12; A61L31/125; A61L31/127; A61L31/129; B; B29; B29C; B29C48/00; B29C48/03; B29C48/09; B29C48/12; B29C48/25; B29C48/36; B29C48/50; B29C48/695; B29C48/70; A61B2017/00526; A61B2017/00831; A61B2017/00898; A61B2017/0404; A61B2017/0409; A61B2017/0414; A61B2017/0445; A61F; A61F2/00; A61F2/02; A61F2/08; A61F2/0811; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2430/00; A61L2430/02
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
55 words
A load bearing hard tissue implant comprising: a resorbable, swellable implant body, wherein the implant body contains at least one hollow channel adapted to receive at least one suture; and a load-distributing device adapted to hold a suture, wherein said implant body has a length and a width and comprises a dehydrated crosslinked biocompatible polymer.
Claim 2
Dependent Claim
55 words
A load bearing hard tissue implant comprising: a resorbable, swellable implant body, wherein the implant body contains at least one hollow channel adapted to receive at least one suture; and a load-distributing device adapted to hold a suture, wherein said implant body has a length and a width and comprises a dehydrated crosslinked biocompatible polymer.
Claim 3
Dependent Claim
17 words
The implant of claim 1, wherein the length of the implant body is greater than the width.
Claim 4
Dependent Claim
13 words
The implant of claim 1, wherein the load-distributing device comprises a biodegradable material.
Claim 5
Dependent Claim
11 words
The implant of claim 1, wherein the implant body is cylindrical.
Claim 6
Dependent Claim
16 words
The implant of claim 1, wherein the biocompatible polymer is crosslinked with an aldehyde-containing crosslinking agent.
Claim 7
Dependent Claim
20 words
The implant of claim 5, wherein the aldehyde-containing crosslinking agent is selected from the group consisting of glutaraldehyde and formaldehyde.
Claim 8
Dependent Claim
12 words
The implant of claim 6, wherein the aldehyde-containing crosslinking agent is glutaraldehyde.
Claim 9
Dependent Claim
16 words
The implant of claim 1, wherein the crosslinking agent is a functionally activated synthetic hydrophilic polymer.
Claim 10
Dependent Claim
24 words
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.
Claim 11
Dependent Claim
18 words
The implant of claim 8, wherein the functionally activated synthetic hydrophilic polymer is a multifunctionally activated polyethylene glycol.
Claim 12
Dependent Claim
21 words
The implant of claim 10, wherein the multifunctionally activated polyethylene glycol is selected from the group consisting of SG-PEG and SE-PEG.
Claim 13
Dependent Claim
12 words
The implant of claim 1, wherein the biocompatible polymer is noncovalently crosslinked.
Claim 14
Dependent Claim
26 words
The implant of claim 12, wherein crosslinking is achieved using a method comprising a step selected from the group consisting of: drying, irradiation, heating and compression.
Claim 15
Dependent Claim
11 words
The implant of claim 1, wherein the biocompatible polymer is collagen.
Claim 16
Dependent Claim
11 words
The implant of claim 12, wherein the collagen is fibrillar collagen.
Claim 17
Dependent Claim
14 words
The implant of claim 1, wherein the implant body further comprises a particulate material.
Claim 18
Dependent Claim
32 words
The implant of claim 14, 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.
Claim 19
Dependent Claim
14 words
The implant of claim 14, wherein the particulate material comprises calcium phosphate ceramic particles.
Claim 20
Dependent Claim
31 words
The implant of claim 15, 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.
Claim 21
Dependent Claim
21 words
The implant of claim 1, wherein the implant body further comprises an effective amount of one or more biologically active agents.
Claim 22
Dependent Claim
14 words
The implant of claim 18, wherein the biologically active agent comprises a growth factor.
Claim 23
Dependent Claim
19 words
The implant of claim 19, wherein said growth factor is a member of the transforming growth factor supergene family.
Claim 24
Dependent Claim
21 words
The implant of claim 1, wherein the implant body has an outer surface, and wherein the outer surface is not smooth.
Claim 25
Dependent Claim
15 words
The implant of claim 21, wherein the outer surface of the implant body is ribbed.
Claim 26
Dependent Claim
26 words
The implant of claim 22, wherein the outer surface of the implant body has three or more ribs running the entire length of the implant body.
Claim 27
Dependent Claim
24 words
The implant of claim 23, wherein the outer surface of the implant body has eight ribs running the entire length of the implant body.
Claim 28
Dependent Claim
47 words
The implant of claim 1 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.
Claim 29
Dependent Claim
38 words
The implant of claim 24, 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.
Claim 30
Dependent Claim
40 words
The implant of claim 25, 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.
Claim 31
Dependent Claim
97 words
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: (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.
Claim 32
Dependent Claim
97 words
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: (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.
Claim 33
Independent Claim
101 words
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.
Claim 34
Independent Claim
101 words
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.
Claim 35
Independent Claim
78 words
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.
Claim 36
Independent Claim
78 words
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.
Claim 37
Independent Claim
92 words
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.
Claim 38
Independent Claim
92 words
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.
Claim 39
Dependent Claim
16 words
The implant of claim 1 wherein said load distributing device is made from a non-biodegradable material.
Claim 40
Dependent Claim
26 words
The implant of claim 34 wherein said load distributing device is made from a material selected from the group consisting of ceramic, a polymer and metal.
Claim 41
Dependent Claim
39 words
The implant of claim 22 wherein said growth factor is selected from the group consisting of beta transforming growth factors, bone morphogenetic proteins, heparin binding growth factors, platelet-derived growth factors, insulin-like growth factors, inhibins, growth differentiating factors, and activins.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-07-04 | 2004-01-03 | 2004-07-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-07-04 | 2008-01-03 | 2008-07-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-07-04 | 2012-01-03 | 2012-07-04 | $7700.00 | Window Closed / Lapsed |