Surgical fastener with predetermined resorption rate

• US 20050267478A1
• Filed: 04/25/2005
• Published: 12/01/2005
• Est. Priority Date: 06/13/2003
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Viola, Frank J., Criscuolo, Christopher J., Fowler, David N., Bettuchi, Michael, Corradi, Ralph Robert, Zergiebel, Earl
• Granted Patent: US 8,002,811 B2
• Time in Patent Office: Days
• US Class Current: 606/916
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/861 specially shaped for gripping driver
• CPC Class Codes: A61B 17/862 at the periphery of the screw head
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/8635 Tips of screws
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 17/869 characterised by an open form, e.g. wire helix
• CPC Class Codes: A61B 17/8883 the driver bit acting on the periphery of the screw head
• CPC Class Codes: A61B 17/8891 at its periphery
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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: B25B 13/481 : for operating in areas having limited access
• CPC Class Codes: B25B 17/00 : Hand-driven gear-operated wrenches or screwdrivers ratchet-operated B25B13/46 B25B13/467, B25B15/04; for mounting or dismounting wheels B60B29/005
• CPC Class Codes: B25B 23/065 : the magazine being coaxial with the tool axis
• CPC Class Codes: B25B 23/101 : for hand-driven screw-drivers B25B23/105 takes precedence
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 606/916 : Tool for installing or removing orthopedic fastener

Abstract

A resorbable screw fastener and a method of firing with an applicator capable of applying a surgical fastener to tissue in order to form tissue connection to secure objects to tissue, the fastener including a body portion having a helical thread, a head portion disposed at the proximal end of the body portion. The resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 14 days to about one year after implantation.

Claims

1. A resorbable screw fastener comprising:

a body portion defining a longitudinal axis and having a proximal end and a distal end, the body portion having a helical thread formed thereon, the helical thread having a first distance; and

a head portion disposed at the proximal end of the body portion, the head portion having driver receiving structure formed therein for transmitting both linear and rotational motion to the body portion, the head portion having an outer diameter substantially equal to the first distance of the helical thread,

wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 14 days to about one year after implantation.

2. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener is formed of at least one material selected from the group consisting of trimethylene carbonate, caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide, homopolymers thereof, copolymers thereof, and combinations thereof.

3. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener is formed of a glycolide-lactide copolymer.

4. The resorbable screw fastener of claim 3, wherein the glycolide-lactide copolymer possesses glycolide in an amount ranging from about 10% to about 50% of the glycolide-lactide copolymer and lactide in an amount ranging from about 90% to about 50% of the glycolide-lactide copolymer.

5. The resorbable screw fastener of claim 3, wherein the glycolide-lactide copolymer possesses glycolide in an amount ranging from about 15% to about 45% of the glycolide-lactide copolymer and lactide in an amount ranging from about 85% to about 55% of the glycolide-lactide copolymer.

6. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener is formed of a glycolide-trimethylene carbonate copolymer.

7. The resorbable screw fastener of claim 6, wherein the glycolide-trimethylene carbonate copolymer possesses glycolide in an amount ranging from about 50% to about 90% of the glycolide-trimethylene carbonate copolymer and trimethylene carbonate in an amount ranging from about 10% to about 50% of the glycolide-trimethylene carbonate copolymer.

8. The resorbable screw fastener of claim 6, wherein the glycolide-trimethylene carbonate copolymer possesses glycolide in an amount ranging from about 55% to about 70% of the glycolide-trimethylene carbonate copolymer and trimethylene carbonate in an amount ranging from about 30% to about 45% of the glycolide-trimethylene carbonate copolymer.

9. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener maintains 80% of its original strength for a period of time ranging from about 5 days to about 45 days after implantation.

10. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener maintains 80% of its original strength for a period of time ranging from about 7 days to about 30 days after implantation.

11. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 21 days to about 3 months after implantation.

12. The resorbable screw fastener of claim 1, wherein the resorbable screw fastener wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 28 days to about 2 months after implantation

13. The resorbable screw fastener of claim 1, wherein said center shaft is tapered from a narrow distal end to a larger proximal.

14. The resorbable screw fastener of claim 1, wherein said driver receiving structure further defines a substantially flattened surface formed in the outer radial surface of the head portion.

15. The resorbable screw fastener of claim 14, wherein the substantially flattened surface extends to at least a portion of the outer radial surface of the thread.

16. The resorbable screw fastener of claim 1, wherein said distal end of the body portion is blunt.

17. The resorbable screw fastener of claim 1, wherein the land of the thread is substantially perpendicular to the longitudinal axis.

18. The resorbable screw fastener of claim 1, wherein a distance of the thread is substantially enlarged.

19. The resorbable screw fastener of claim 1, wherein the distance of the head portion is about 3.8 mm.

20. The resorbable screw fastener of claim 1, wherein a height of the head portion is about 1.5 mm.

21. The resorbable screw fastener of claim 1, wherein a length of the body portion is about 5 mm in length.

22. The resorbable screw fastener of claim 1, further including a lumen extending through an entire length thereof.

23. The resorbable screw fastener of claim 22, wherein said body portion has a circular cross section.

24. A method of inserting a resorbable screw fastener of claim 1, the method comprising the steps of tapping the target tissue with a pilot, and installing the resorbable screw fastener by applying linear and rotational force on the head portion.

25. A resorbable screw fastener and instrument for inserting the resorbable screw fastener, comprising:

an instrument having an outer tube on a distal end and a trigger mechanism on its proximal end; and

a resorbable screw fastener having a body portion and a head portion disposed at the proximal end of the body portion, the fastener being inserted on the distal end of the instrument, the head of the resorbable screw fastener having a driver receiving configuration formed therein for transmitting both linear and rotational motion to the body portion,

wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 14 days to about one year after implantation.

26. A resorbable screw fastener comprising:

a body portion defining a longitudinal axis and having a proximal end and a distal end, the body portion having a helical thread formed thereon, the helical thread having a first distance; and

a head portion disposed at the proximal end of the body portion, the head portion having driver receiving structure formed therein for transmitting rotational motion to the body portion, the head portion having an outer diameter substantially equal to the first distance of the helical thread,

wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 14 days to about one year after implantation.

27. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener is formed of at least one material selected from the group consisting of trimethylene carbonate, caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide, homopolymers thereof, copolymers thereof, and combinations thereof.

28. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener is formed of a glycolide-lactide copolymer.

29. The resorbable screw fastener of claim 28, wherein the glycolide-lactide copolymer possesses glycolide in an amount ranging from about 10% to about 50% of the glycolide-lactide copolymer and lactide in an amount ranging from about 90% to about 50% of the glycolide-lactide copolymer.

30. The resorbable screw fastener of claim 28, wherein the glycolide-lactide copolymer possesses glycolide in an amount ranging from about 15% to about 45% of the glycolide-lactide copolymer and lactide in an amount ranging from about 85% to about 55% of the glycolide-lactide copolymer.

31. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener is formed of a glycolide-trimethylene carbonate copolymer.

32. The resorbable screw fastener of claim 31, wherein the glycolide-trimethylene carbonate copolymer possesses glycolide in an amount ranging from about 50% to about 90% of the glycolide-trimethylene carbonate copolymer and trimethylene carbonate in an amount ranging from about 10% to about 50% of the glycolide-trimethylene carbonate copolymer.

33. The resorbable screw fastener of claim 31, wherein the glycolide-trimethylene carbonate copolymer possesses glycolide in an amount ranging from about 55% to about 70% of the glycolide-trimethylene carbonate copolymer and trimethylene carbonate in an amount ranging from about 30% to about 45% of the glycolide-trimethylene carbonate copolymer.

34. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener maintains 80% of its original strength for a period of time ranging from about 5 days to about 45 days after implantation.

35. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener maintains 80% of its original strength for a period of time ranging from about 7 days to about 30 days after implantation.

36. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 21 days to about 3 months after implantation.

37. The resorbable screw fastener of claim 26, wherein the resorbable screw fastener wherein the resorbable screw fastener is 100% resorbed in vivo during a period of time ranging from about 28 days to about 2 months after implantation.

38. The resorbable screw fastener of claim 26, wherein the driver receiving structure further defines a slot formed in the outer radial surface of the head portion.

39. The resorbable screw fastener of claim 38, wherein the slot extends the entire length of the screw fastener.

40. The resorbable screw fastener of claim 26, wherein the distal end of the body portion defines a distal surface which is angled with respect to the longitudinal axis.

41. The resorbable screw fastener of claim 40, wherein the distal surface of the distal end of the body portion is angled at about 5°

to about 15°

with respect to an axis which is perpendicular to the longitudinal axis.

42. The resorbable screw fastener of claim 26, wherein the head portion defines a distal surface which is angled with respect to the longitudinal axis.

43. The resorbable screw fastener of claim 42, wherein the distal surface of the head portion is angled at about 5°

to about 15°

with respect to an axis which is perpendicular to the longitudinal axis.

44. The resorbable screw fastener of claim 43, wherein the distal surface of the distal end of the body portion is angled at about 5°

to about 15°

with respect to an axis which is perpendicular to the longitudinal axis.

45. The resorbable screw fastener of claim 44, wherein each slot formed in each thread includes at least one of a radiused leading edge and a radiused trailing edge.

46. A resorbable screw fastener comprising:

a body portion defining a longitudinal axis and having a proximal end and a distal end, the body portion having a helical thread formed thereon, the helical thread having a first distance; and

a head portion disposed at the proximal end of the body portion, the head portion having driver receiving structure formed therein for transmitting both linear and rotational motion to the body portion, the head portion having an outer diameter substantially equal to the first distance of the helical thread,

wherein the resorbable screw fastener has a shear strength of about 3.5 pounds to about 5.5 pounds during a period of time ranging from the time of implantation in vivo to about one week after implantation, a shear strength ranging from about 0.5 pounds to about 4.2 pounds during a period of time ranging from about one week to about 1.5 weeks after implantation, and a shear strength of about 0 pounds about one year after implantation.