Impermanent biocompatible fastener

• US 7,442,201 B2
• Filed: 11/12/2003
• Issued: 10/28/2008
• Est. Priority Date: 08/23/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Levendusky, Joseph A., Pugsley, Charles H.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/712,966
• Publication Number:
  US 20040097987A1
• Time in Patent Office: 1,812 Days
• Field of Search: 606/72, 606/73, 606 75- 77, 606/219, 606/220, 606/151, 606/153, 606/154, 606213-215, 606/232, 424422-424, 623/1.38, 623 146- 148
• US Class Current: 606/220
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004

Abstract

A biocompatible fastener particularly well-suited for use in fundoplication procedures. In a preferred embodiment, the fastener is designed to break within the span of approximately three to six months after implantation and comprises a male portion and a female portion. The male portion includes a first base member, the first base member being generally flat and oval. A pair of male members are mounted on the bottom surface of the first base member, each male member comprising a cylindrical post extending downwardly from the bottom surface of the first base member and a conical head disposed at the bottom end of the post. The female portion includes a second base member, the second base member being generally flat and oval. A pair of sleeves are mounted on the top surface of the second base member and extend upwardly therefrom. Each sleeve defines a bore adapted to receive a head from a corresponding male member and has an inner flange formed thereon. The flange extends radially into the bore and is engageable with the head once the head has been inserted therepast so as to inhibit withdrawal of the head from the bore. Except for an outer coating on each of the two heads, the fastener is made entirely of a non-bioabsorbable material or a bioabsorbable material having a relatively slow degradation rate. By contrast, the outer coating is made of a bioabsorbable material having a relatively fast degradation rate. The thickness of the outer coating is appropriately selected so that degradation of the outer coating permits each head to be withdrawn past its flange after a desired period of time.

Claims

1. A biocompatible fastener, said biocompatible fastener comprising a pair of members matingly engageable with one another, at least one of said members comprising an outer coating coated over an inner core, said outer coating comprising a first bioabsorbable material, said inner core comprising one of a second bioabsorbable material and a non-bioabsorbable material, said first bioabsorbable material having a first degradation rate, said second bioabsorbable material having a second degradation rate, said second degradation rate being slower than said first degradation rate, wherein, after said pair of members have been matingly engaged with one another, degradation of said outer coating over said inner core causes said pair of members to disengage from one another, and wherein one of said pair of members is a male member and the other of said pair of members is a female member, said male member comprising a head, said female member comprising a bore adapted to receive said head and comprising a flange extending into said bore, said head being engageable with said flange once said head has been inserted therepast so as to inhibit withdrawal of said head.

2. The biocompatible fastener as claimed in claim 1 wherein said inner core comprises said non-bioabsorbable material.

3. The biocompatible fastener as claimed in claim 1 wherein said inner core comprises said second bioabsorbable material.

4. The biocompatible fastener as claimed in claim 1 wherein only one of said members comprises said outer coating coated over said inner core.

5. The biocompatible fastener as claimed in claim 1 wherein said head comprises said outer coating coated over said inner core and wherein degradation of said outer coating permits withdrawal of said head past said flange.

6. The biocompatible fastener as claimed in claim 1 wherein said flange comprises said outer coating coated over said inner core and wherein degradation of said outer coating permits withdrawal of said head past said flange.

7. The biocompatible fastener as claimed in claim 1 wherein said female member comprises at least two flanges extending into said bore.

8. The biocompatible fastener as claimed in claim 7 wherein said female member comprises at least three flanges extending into said bore.

9. The biocompatible fastener as claimed in claim 8 wherein said female member comprises at least four flanges extending into said bore.

11. The biocompatible fastener as claimed in claim 1 wherein said female members comprises a flat base shaped to include said bore and said flange.

12. The biocompatible fastener as claimed in claim 1 wherein said pair of members are configured to fasten together two or more biological materials.

26. The biocompatible fastener as claimed in claim 1 wherein said head is generally conical.

10. The biocompatible fastener as claimed in 9 wherein said female member comprises five flanges extending into said bore.

13. A biocompatible fastener comprising:

(a) a sleeve, said sleeve defining a bore;

(b) a substantially circumferential flange formed on said sleeve and extending into said bore;

(c) a male member, said male member comprising a post and a head disposed at first end of said post, said head being insertable into said bore and past said flange, said head being engageable with said flange once inserted therepast so as to inhibit withdrawal of said head from said bore;

(d) wherein at least one of said flange and said head comprises an outer coating material and an inner core material, said outer coating material being a first bioabsorbable material having a first degradation rate, said inner core material being a material selected from the group consisting of a non-bioabsorbable material and a second bioabsorbable material, said second bioabsorbable material having a second degradation rate, said second degradation rate being slower than said first degradation rate; and

(e) wherein degradation of said outer coating material facilitates withdrawal of said head past said flange.

14. The biocompatible fastener as claimed in claim 13 further comprising a first base and a second base, said sleeve being mounted on said first base, said male member being mounted on said second base.

15. The biocompatible fastener as claimed in claim 14 wherein said sleeve is provided with a longitudinal slot.

16. The biocompatible fastener as claimed in claim 14 wherein said sleeve is provided with a pair of longitudinal slots.

17. The biocompatible fastener as claimed in claim 14 wherein said sleeve terminates at one end in a sharp tip.

18. A biocompatible fastener comprising:

(a) a male portion, said male portion comprising

(i) a first base member, said first base member having a bottom surface, and

(ii) a first male member mounted on said bottom surface of said first base member, said first male member comprising a post extending downwardly from said bottom surface, said post having a bottom end, and a head disposed at said bottom end of said post; and

(b) a female portion, said female portion comprising

(i) a second base member, said second base member having a top surface, and

(ii) a first sleeve mounted on said top surface of said second base member and extending upwardly therefrom, said first sleeve defining a bore adapted to receive said head and having at least one flange formed thereon, said at least one flange extending into said bore, said at least one flange being engageable with said head once said head has been inserted therepast so as to inhibit withdrawal of said head from said bore;

(c) wherein at least one of said at least one flange and said head comprises an outer coating coated over an inner core, said outer coating comprising a first bioabsorbable material, said inner core comprising one of a non-bioabsorbable material and a second bioabsorbable material, said first bioabsorbable material having a first degradation rate, said second bioabsorbable material having a second degradation rate, said second degradation rate being slower than said first degradation rate; and

(d) wherein degradation of said first bioabsorbable material facilitates withdrawal of said head past said at least one flange.

19. The biocompatible fastener as claimed in claim 18 wherein said head is generally conical in shape and terminate in a relatively sharp tip.

20. The biocompatible fastener as claimed in claim 18 wherein said first member is generally flat and oval.

21. The biocompatible fastener as claimed in claim 18 wherein said second base member is generally flat and oval.

22. The biocompatible fastener as claimed in claim 18 wherein said first sleeve is provided with at least one longitudinal slot.

23. The biocompatible fastener as claimed in claim 18 wherein said first sleeve is provided with a pair of longitudinal slots.

24. The biocompatible fastener as claimed in claim 18 wherein said male portion further comprises a second male member mounted on said first base member and extending downwardly therefrom, and said second male member being identical to said first male member, and wherein said female portion further comprising a second sleeve mounted on said second base member and extending upwardly therefrom, said second sleeve being aligned with said second male member and being a mirror image of said first sleeve.

25. A biocompatible fastener comprising:

(a) a male portion, said male portion comprising

(i) a first base member, said first base member having a bottom surface, and

(ii) a first male member mounted on said bottom surface of said first base member, said first male member comprising a post extending downwardly from said bottom surface, said post having a bottom end, and a head disposed at said bottom end of said post; and

(b) a female portion, said female portion comprising

(i) a second base member, said second base member having a top surface, and

(ii) a first sleeve mounted on said top surface of said second base member and extending upwardly therefrom, said first sleeve defining a bore adapted to receive said head and having a flange formed thereon, said flange extending into said bore, said flange being engageable with said head once said head has been inserted therepast so as to inhibit withdrawal of said head from said bore;

(c) wherein at least one of said flange and said head is at least partially made of a first bioabsorbable material having a first degradation rate and wherein at least one of said first base member and said second base member comprises a material selected from the group consisting of a non-bioabsorbable material and a second bioabsorbable material, said second bioabsorbable material having a second degradation rate, said second degradation rate being slower than said first degradation rate;

(d) wherein degradation of said first bioabsorbable material facilitates withdrawal of said head past said flange and

(e) wherein said first sleeve has a top end and wherein said top end is shaped to terminate in a relatively sharp tip.