Biodegradable stent

• US 5,085,629 A
• Filed: 09/27/1989
• Issued: 02/04/1992
• Est. Priority Date: 10/06/1988
• Status: Expired due to Term

• Current Assignee: Cabot Corporation
• Original Assignee: Medical Engineering Corporation
• Inventors: Goldberg, Jay, Sinclair, Richard
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Polutta, Mark O.
• Application Number:
  US07/414,651
• Time in Patent Office: 860 Days
• Field of Search: 604/8, 604/264, 604/265, 604/275, 128/656-658, 128/898, 623/12, 606/151, 606/154, 606/228, 606/230
• US Class Current: 604/8
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biodegradable, biocompatible, resorbable infusion stent comprising a terpolymer of:

(a) L(-)lactide,

(b) glycolide, and

(c) epsilon-caprolactone.

This invention includes a method for treating ureteral obstructions or impairments by utilizing a biodegradable, biocompatible, resorbable infusion stent, and a method for controlling the speed of resorption of the stent.

Claims

1. A biodegradable, biocompatible, resorbable, ureteral stent having retaining means to prevent migration from a predetermined position in the ureter, said stent comprising a terpolymer of:

(a) L(-) lactide

(b) glycolide, and

(c) epsilon-caprolactone.

2. The ureteral stent of claim 1, wherein the epsilon-caprolactone varies from about 15 to 25 weight %.

3. The ureteral stent of claim 1, wherein the L(-)lactide varies from about 45 to 85 weight %.

4. The ureteral stent of claim 1, wherein the glycolide varies from about 5 to 50 weight %.

5. The ureteral stent of claim 1, also including about 5 to 30 weight % of a radiopaque material.

6. The ureteral stent of claim 5, wherein said radiopaque material is finely divided barium sulfate.

7. The ureteral stent of claim 1, wherein the modulus varies from about 6000 to 7000 psi.

8. The ureteral stent of claim 1, bendable into a pliable curl set at each end.

9. The ureteral stent of claim 1, sterilizable and capable of compounding with radiopaque materials.

10. The ureteral stent of claim 1, in transparent form.

11. The ureteral stent of claim 1, wherein the terpolymer has a weight average molecular weight varying from about 20,000 to 1,000,000.

12. The ureteral stent of claim 1, wherein the terpolymer has a melt process decomposition temperature greater than or equal to about 230°

C.

13. The ureteral stent of claim 1, wherein the terpolymer has a tube extrusion processing temperature that varies from about 135°

to 150°

C.

14. The ureteral stent of claim 11, wherein, the terpolymer has a weight average molecular weight of about 50,000 to 400,000.

15. The ureteral stent of claim 1, having:

(i) a tensile strength of at least about 500 psi,

(ii) an elongation greater than about 10%, and

(iii) Shore A hardness of about 50 to 100.

16. A method for treating ureteral obstruction or impairment in a mammalian host by inserting in the ureter in a predetermined location, a biodegradable, biocompatible resorbable non-anastomosis polymeris stent extending between the kidney and the bladder, said stent having end portions with pliable retaining means to prevent migration before biodegradation, without the need for suturing, from the predetermined location in the ureter.

17. The method of claim 16, wherein said stent has the following properties:

(i) a tensile strength of at least about 500 psi,

(ii) an elongation greater than about 10%, and

(iii) Shore A hardness of about 50 to 100.

18. The method of claim 16, wherein the stent has the following properties:

(a) tensile strength greater than 1000 psi,

(b) elongation greater than 100%, and

(c) Shore A hardness of about 75 to 95.

19. The method of claim 16, wherein said stent comprises a polymeric material having a weight average molecular weight varying from about 50,000 to 400,000.

20. The method of claim 16, wherein the stent comprises at least one polymer selected from the group consisting of L(-)lactide, glycolide, epsilon-caprolactone, D(-)lactide, meso-lactide, D,L-lactide, and delta-valero-lactone.

25. A method for controlling the time of biodegradation in the ureter of a polymeric, biodegradable, biocompatible, resorbable non-anastomosis ureteral stent by

(a) inserting a stent in the ureter in a predetermined location between the kidney and the bladder to relieve ureteral obstruction;

(b) providing end portions of the stent with pliable retaining means to prevent migration of the stent before biodegradation, without the need for suturing; and

(c) controlling the rate of biodegradation of said polymeric stent from a few weeks to a few months, by varying the molecular weight of the polymer composition comprising the stent, from a weight average molecular weight of about 20,000 to about 1,000,000.

21. The method of claim 29, wherein the stent comprises of terpolymer of:

(a) L(-)lactide,

(b) glycolide, and

(c) epsilon-caprolactone.

22. The method of claim 21, wherein the L(-)lactide varies from about 45 to 85 weight %.

23. The method of claim 21, wherein the glycolide varies from about 5 to 50 weight %.

24. The method of claim 21, wherein the epsilon-caprolactone varies from about 15 to 25 weight %.

26. The method of claim 25, wherein the stent comprises a terpolymer of:

(a) L(-)lactide,

(b) glycolide, and

(c) epsilon-caprolactone.

27. The method of claim 25, wherein the weight average molecular weight of said polymeric stent varies from about 50,000 to about 400,000.

28. The method of claim 25, wherein the stent comprises at least one polymer selected from the group consisting of L(-)lactide, glycolide, epsilon-caprolactone, D(-)lactide, meso-lactide, D,L-lactide, and delta-valero-lactone.

29. The method of claim 25, wherein the average molecular weight varies from about 50,000 to about 400,000.

30. The method of claim 25, wherein said stent has the following properties:

(i) a tensile strength of at least about 500 psi,

(ii) an elongation greater than about 10%, and

(iii) Shore A hardness of about 50 to 100.

31. A method for relieving ureteral obstruction in a mammalian host, comprising:

(a) forming a tubular polymeric, biodegradable, biocompatible resorbable non-anastomosis ureteral stent having end portions with pliable retaining means to prevent migration before biodegradation, without the need for suturing, from a predetermined position in the ureter, and wherein said stent substantially extends from the kidney to the bladder;

(b) controlling the rate of biodegradation of said polymeric stent by varying the molecular weight of the polymer composition comprising the stent, from a weight average molecular weight of about 50,000 to about 1,000,000, and

(c) inserting said positioning said ureteral stent in the ureter in a predetermined location between the kidney and the bladder.

32. The method of claim 31, wherein said stent has the following properties:

(i) a tensile strength of at least about 500 psi,

(ii) an elongation greater than about 10%, and

(iii) Shore A hardness of about 50 to 100.