US5275826A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Fluidized intestinal submucosa and its use as an injectable tissue graft
Assignee: Methodist Hospital
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Filing: 1992-11-13
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Granted: 1994-01-04
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Expires: 2012-11-13
Abstract
Abstract A fluidized, injectable tissue graft composition is described. The composition comprises comminuted intestinal submucosa or protease-digested intestinal submucosa. Methods for the preparation and use of injectable tissue graft compositions are described. In preferred embodiments the tissue graft material is prepared from the intestinal submucosa comprising the tunica submucosa, the muscularis mucosa and the stratum compactum of a segment of intestinal tissue of a warm-blooded vertebrate. Effective amounts of the fluidized graft compositions can be injected to promote repair tissue defects by inducing formation of endogenous tissues.
Inventors
- 👤 Stephen F. Badylak
- 👤 Robert J. Demeter
- 👤 Michael Hiles
- 👤 Sherry Voytik
- 👤 Peter M. Knapp, Jr.
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 22:32
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3695; A61F; A61F2/00; A61F2/02; A61F2/28; A61K; A61K35/00; A61K35/12; A61K35/37; A61K35/38; A61L27/3604; A61L27/3629; A61L27/3641; A61L27/3645; A61L27/365; A61L27/367; A61L27/3691; A61P; A61P3/00; A61P43/00; A61F2002/2835; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30667; A61F2002/30677; A61F2210/00; A61F2210/0004; A61L2400/00; A61L2400/06
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
70 words
A method of preparing an injectable tissue graft composition, said method comprising the steps of comminuting intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate and hydrating the resultant comminuted intestinal tissue to provide said tissue graft composition as a fluid having a viscosity of about 2 to about 300,000 cps at 25° C.
Claim 2
Independent Claim
70 words
A method of preparing an injectable tissue graft composition, said method comprising the steps of comminuting intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate and hydrating the resultant comminuted intestinal tissue to provide said tissue graft composition as a fluid having a viscosity of about 2 to about 300,000 cps at 25° C.
Claim 3
Dependent Claim
23 words
The method of claim 1, wherein the comminuting step includes the step of freezing the intestinal tissue and grinding the frozen intestinal tissue.
Claim 4
Dependent Claim
23 words
The method of claim 1 wherein the comminuting step includes the steps of freeze-drying the intestinal tissue and grinding the freeze-dried intestinal tissue.
Claim 5
Dependent Claim
22 words
The method of claim 1 wherein the comminuting step includes the step of processing the intestinal tissue in a high shear blender.
Claim 6
Dependent Claim
15 words
The method of claim 1 further comprising the step of sterilizing the tissue graft composition.
Claim 7
Dependent Claim
39 words
The method of claim 1 further comprising the step of digesting the comminuted intestinal tissue with a protease for a period of time sufficient to solubilize said tissue to provide the tissue graft composition as a substantially homogeneous solution.
Claim 8
Dependent Claim
19 words
The method of claim 6, further comprising the step of neutralizing the substantially homogeneous solution to inactivate the protease.
Claim 9
Dependent Claim
19 words
The method of claim 6, further comprising the step of isolating the solubilized tissue from the substantially homogeneous solution.
Claim 10
Independent Claim
64 words
A method of preparing an injectable tissue graft composition, said method comprising the step of digesting intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in aqueous solution with a protease for a period of time sufficient to solubilize said intestinal tissue to form a substantially homogeneous solution.
Claim 11
Independent Claim
64 words
A method of preparing an injectable tissue graft composition, said method comprising the step of digesting intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in aqueous solution with a protease for a period of time sufficient to solubilize said intestinal tissue to form a substantially homogeneous solution.
Claim 12
Dependent Claim
19 words
The method of claim 9, further comprising the step of neutralizing the substantially homogeneous solution to inactivate the protease.
Claim 13
Dependent Claim
19 words
The method of claim 9, further comprising the step of isolating the solubilized tissue from the substantially homogeneous solution.
Claim 14
Dependent Claim
40 words
An injectable, non-immunogenic tissue graft composition comprising a suspension of comminuted intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in an aqueous carrier.
Claim 15
Dependent Claim
40 words
An injectable, non-immunogenic tissue graft composition comprising a suspension of comminuted intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in an aqueous carrier.
Claim 16
Dependent Claim
18 words
The composition of claim 12 having a viscosity of about 2 to about 300,000 cps at 25° C.
Claim 17
Dependent Claim
40 words
An injectable, non-immunogenic tissue graft composition comprising a suspension of protease-digested intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in an aqueous carrier.
Claim 18
Dependent Claim
40 words
An injectable, non-immunogenic tissue graft composition comprising a suspension of protease-digested intestinal tissue consisting essentially of the tunica submucosa, the muscularis mucosa and stratum compactum of the tunica mucosa of the intestine of a warm-blooded vertebrate in an aqueous carrier.
Claim 19
Dependent Claim
18 words
The composition of claim 14 having a viscosity of about 2 to about 300,000 cps at 25° C.
Claim 20
Dependent Claim
13 words
The composition of claim 14, wherein the composition is substantially free of protease.
Claim 21
Dependent Claim
32 words
A method of promoting wound healing in a patient in need thereof comprising the step of applying to a wound an effective amount of the injectable tissue graft composition of claim 12.
Claim 22
Dependent Claim
13 words
The injectable tissue graft composition of claim 12, dried and in powder form.
Claim 23
Dependent Claim
13 words
The injectable tissue graft composition of claim 14, dried and in powder form.
Claim 24
Dependent Claim
46 words
A method for inducing the formation of endogenous connective tissue in a warm-blooded vertebrate in need thereof comprising administering an effective amount of the tissue graft composition of claim 12 in an amount effective to induce endogenous tissue growth at the site the composition is administered.
Claim 25
Dependent Claim
21 words
The method of claim 20 wherein the growth induced endogenous tissue is bone or connective tissue comprising collagen, elastin or muscle.
Claim 26
Dependent Claim
31 words
The method of claim 20 wherein the tissue graft composition is injected into tissue forming a sphincter in a warm-blooded mammal and the growth induced tissue is tissue forming the sphincter.
Claim 27
Dependent Claim
33 words
A method for augmenting sphincter function in a mammal in need thereof comprising the step of injecting an effective amount of the tissue graft composition of claim 12 into tissue forming said sphincter.
Claim 28
Dependent Claim
32 words
A method of promoting wound healing in a patient in need thereof comprising the step of applying to a wound an effective amount of the injectable tissue graft composition of claim 14.
Claim 29
Dependent Claim
46 words
A method for inducing the formation of endogenous connective tissue in a warm-blooded vertebrate in need thereof comprising administering an effective amount of the tissue graft composition of claim 14 in an amount effective to induce endogenous tissue growth at the site the composition is administered.
Claim 30
Dependent Claim
33 words
A method for augmenting sphincter function in a mammal in need thereof comprising the step of injecting an effective amount of the tissue graft composition of claim 14 into tissue forming said sphincter.
References Cited (Backward Citations)
US4902508A
Cited
US4956178A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-01-03 | 1997-07-05 | 1998-01-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-01-03 | 2001-07-05 | 2002-01-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-01-03 | 2005-07-05 | 2006-01-04 | $7700.00 | Window Closed / Lapsed |