Method and apparatus for delivering a shape memory article to a surgical site

• US 8,596,514 B2
• Filed: 02/19/2010
• Issued: 12/03/2013
• Est. Priority Date: 03/19/2009
• Status: Active Grant

• Current Assignee: OsteoMed, LLC
• Original Assignee: OT Medical, LLC
• Inventors: Miller, Alan B., Huxel, Shawn T., Briganti, Richard Thomas
• Primary Examiner(s): Lopez, Michelle
• Application Number:
  US12/708,973
• Publication Number:
  US 20100237128A1
• Time in Patent Office: 1,383 Days
• Field of Search: 227/175.1, 227/176.1, 227/181.1, 227/147, 411/904, 411/909, 128/898, 606/219
• US Class Current: 227/175.1
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself

Abstract

The invention pertains to a method and apparatus for delivering an article formed of a shape memory alloy to a surgical implantation site. The apparatus may include a body having a passage for receiving the proximal portion of the shape memory article, the passage being shaped to substantially prevent the shape memory article from deforming in accordance with its shape memory properties when the proximal portion of the shape memory article is positioned in the passage. An exemplary involves placing the distal portions of legs of a staple in at least one passage in a constraining device that substantially constrains the legs from deforming; and placing the proximal portions of the legs of the staple in at least one passage in an apparatus that, independently of the constraining device, substantially prevents the legs from deforming.

Claims

1. An apparatus for holding a shape memory article, the shape memory article comprising a proximal portion and a distal portion and adapted to be implanted into an anatomical feature with the distal portion first, the apparatus comprising:

a body extending longitudinally from a proximal end to a distal end, the body having a passage for receiving the proximal portion of the shape memory article, the passage comprising a groove on the body'"'"'s outer surface that opens transversely to the body, the passage being shaped to substantially prevent the shape memory article from deforming in accordance with its shape memory properties when the proximal portion of the shape memory article is positioned in the passage wherein the body is a unitary body and the passage formed in the unitary body is shaped and sized so that the distal portion of the shape memory article can be implanted into an anatomical feature while the shape memory article is positioned in the passage of the apparatus.

2. A combination comprising the apparatus of claim 1 and the shape memory article.

3. The combination of claim 2 wherein the shape memory article is a medical staple and wherein the proximal portion of the staple comprises a backspan and proximal portions of legs extending from the backspan, and the distal portion of the staple comprises distal portions of the legs.

4. The combination of claim 2 wherein the body has a lateral surface extending from the proximal end to the distal end, the passage comprising a first groove open to a lateral surface of the body.

5. The combination of claim 4 wherein the first groove comprises at least a portion bearing a detent adapted to hold the shape memory article in the groove.

6. The combination of claim 5 wherein the detent comprises an overhang defining a clearance that is less than a diameter of a section of the proximal portion of the shape memory article.

7. The combination of claim 5 further comprising a second groove in the apparatus positioned and shaped to enhance flexibility of a portion of the apparatus adjacent to a portion of the first groove bearing the detent for permitting the shape memory article to be forced past the detent as the enhanced-flexibility portion of the apparatus is deflected into the second groove.

8. The combination of claim 4 wherein the first groove comprises a first portion adapted to receive a backspan of a shape memory staple and second and third portions adapted to receive proximal portions of first and second legs of the medical staple, respectively.

9. A combination of the apparatus and shape memory article of claim 2 in further combination with a constraining device, the constraining device comprising a passage sized and shaped to receive the distal portion of the shape memory article so as to substantially prevent the distal portion of the shape memory article from deforming.

10. The combination of claim 9 wherein the apparatus comprises a first surface from which the distal portion of the shape memory article will extend when the proximal portion of the shape memory article is positioned in the passage in the apparatus, and the constraining device comprises a second surface from which the proximal portion of the shape memory article will extend when the distal portion of the shape memory article is positioned in the passage in the constraining device.

11. The combination of claim 10 wherein the first surface of the apparatus and the second surface of the constraining device abut when the proximal portion of the shape memory article is positioned in the apparatus and the distal portion of the shape memory article is positioned in the passage of the constraining device.

12. The combination of claim 10 wherein the shape memory article comprises a medical staple having a backspan and first and second legs extending from the backspan, the first and second legs having proximal portions adjacent to the backspan and distal portions and wherein the passage in the constraining device comprises two bores positioned, sized, and shaped to receive the distal ends of the first and second legs of the medical staple.

13. The apparatus of claim 1, wherein the body further comprising a first surface from which the distal portion of the shape memory article will extend when the proximal portion of the shape memory article is positioned in the passage in the apparatus and a grasping portion extending away from the passage in a direction opposite from the direction of extension of the distal portion of the shape memory article.

14. An apparatus for holding a shape memory article, the shape memory article comprising a proximal portion and a distal portion and adapted to be implanted into an anatomical feature with the distal portion first, the apparatus comprising:

a body extending longitudinally from a proximal end to a distal end, the body having a passage for receiving the proximal portion of the shape memory article, the passage comprising a groove on the body'"'"'s outer surface that opens transversely to the body, the passage being shaped to substantially prevent the shape memory article from deforming in accordance with its shape memory properties when the proximal portion of the shape memory article is positioned in the passage further comprising a cover movable on the body between a closed position in which the cover covers at least a portion of the passage so as to prevent a shape memory article positioned in the passage from being removed from the passage and a second position in which the cover does not cover the passage so that a shape memory article positioned in the passage can be removed from the passage.

15. The apparatus of claim 14 wherein the cover is slidably attached to the body.

16. A combination comprising the apparatus of claim 15 and the shape memory article, wherein the shape memory article is a medical staple and wherein the proximal portion of the staple comprises a backspan and proximal portions of legs extending from the backspan, and the distal portion of the staple comprises distal portion of the legs and wherein the passage comprises a groove on a surface of the apparatus and wherein the cover covers the surface of the apparatus above the groove when in the closed position and does not cover the surface of the apparatus above the groove when in the closed position.

17. The combination of claim 16 wherein the groove comprises a first portion adapted to receive a backspan of the shape memory staple and second and third portions adapted to receive proximal portions of first and second legs of the medical staple, respectively, the first portion of the groove being shaped to provide a clearance space for accommodating a zigzag shaped backspan of the staple during twisting of the staple about an axis generally parallel to the backspan.

18. An apparatus for holding a shape memory article, the shape memory article comprising a proximal portion and a distal portion and adapted to be implanted into an anatomical feature with the distal portion first, the apparatus comprising:

a body extending longitudinally from a proximal end to a distal end, the body having a passage for receiving the proximal portion of the shape memory article, the passage comprising a groove on the body'"'"'s outer surface that opens transversely to the body, the passage being shaped to substantially prevent the shape memory article from deforming in accordance with its shape memory properties when the proximal portion of the shape memory article is positioned in the passage, the body further comprising a ramp portion having a height that varies along its length.

19. The apparatus of claim 18 wherein the passage defines a depth of the shape memory article that must be exposed in order for the shape memory article to be received in the passage and wherein the ramp portion has a maximum height substantially equal to the depth.

20. The apparatus of claim 18 wherein the shape memory article comprises a medical staple having a backspan and first and second legs extending from the backspan, the first and second legs having proximal portions adjacent to the backspan and distal portions and wherein the ramp portion has a maximum height and wherein the passage in the apparatus is adapted to receive the backspan and the proximal portions of the legs of the medical staple and wherein the passage in the apparatus comprises a groove in a first surface of the apparatus, the groove comprising a first portion adapted to receive the backspan of the medical staple and second and third portions adapted to receive the proximal portions of the first and second legs of the medical staple, the second and third portions of the groove each having a length and extending and open to a second surface of the apparatus from which the distal portions of the legs of the medical staple will extend when the maximal portion of the medical staple is positioned within the passage and wherein the length of the second and third portions of the groove is substantially equal to the maximum height of the ramp.

21. A method of handling a shape memory staple comprising a backspan and first and second legs, the legs having proximal portions attached to the backspan and distal portions, the method comprising:

placing the distal portions of the legs of the staple in at least one passage in a constraining device that substantially constrains the legs from deforming; and

while the distal portions of the legs of the staple are in the constraining device, placing the proximal portions of the legs of the staple in at least one passage in an apparatus that, independently of the constraining device, substantially prevents the legs from deforming; and

pulling the apparatus away from the constraining device to release the distal portions of the legs of the staple from the constraining device, and to transfer the staple from the constraining device to the apparatus.

22. The method of claim 21 wherein the passage in the apparatus comprises a groove in a first surface of the apparatus, the groove comprising a first portion adapted to receive a backspan of the shape memory staple and second and third portions adapted to receive proximal portions of first and second legs of the medical staple, the second and third portions of the groove each having a length and extending and open to a second surface of the apparatus, the method further comprising:

implanting the distal portions of the legs of the staple in an anatomic feature while holding the staple via the apparatus.

23. The method of claim 22 further comprising:

removing the staple from the apparatus after the distal portions of the legs are implanted.

24. The method of claim 23 further comprising:

pushing the staple further into the anatomical feature after the staple is removed from the apparatus.

25. The method of claim 23 wherein the removing of the staple from the apparatus comprises removing the staple from the groove through the first surface of the apparatus.

26. The method of claim 25 wherein the removing comprises rotating the apparatus relative to the staple about an axis substantially parallel to the first and second legs of the staple.

27. The method of claim 25 wherein the removing comprises:

rotating the apparatus relative to the staple about a first axis substantially collinear with the first leg of the staple to remove the second leg of the staple from the groove; and

subsequently rotating the apparatus relative to the staple about a second axis substantially parallel and not collinear with the first leg of the staple to remove the first leg from the groove.

28. The method of claim 25 wherein the removing comprises:

rotating the apparatus relative to the staple about an axis substantially parallel to the backspan of the staple to remove the first and second legs of the staple from the groove; and

after the rotating, pulling the apparatus away from the staple.

29. The method of claim 25 wherein the apparatus further comprises a cover movable between a closed position in which the cover covers at least a portion of the passage so as to prevent the staple from being removed from the passage and a second position in which the cover does not cover the passage so that the staple can be removed from the passage, the method further comprising:

maintaining the cover in the closed position during the pulling; and

moving the cover into the open position prior to the removing.

30. A method of handling a shape memory staple, the shape memory staple comprising a backspan and first and second legs, the legs having proximal portions attached to the backspan and distal portions, the method comprising:

placing the legs of the staple in at least one passage in a constraining device that substantially constrains the legs from deforming, the backspan of the staple positioned without the constraining device but adjacent a first surface of the constraining device;

inserting a ramp of an apparatus between the backspan and the first surface of the constraining device to force the backspan away from the first surface of the constraining device and expose a proximal portion of the legs without the constraining device;

while the distal portions of the legs of the staple are in the constraining device, placing the proximal portions of the legs of the staple in a passage in the apparatus that, independently of the constraining device, substantially prevents the legs from deforming; and

pulling the apparatus away from the constraining device to release distal portions of the legs of the staple from the constraining device, and to transfer the staple from the constraining device to the apparatus.

31. The method of claim 30 further comprising:

implanting the distal portions of the legs of the staple in an anatomic feature while holding the staple via the apparatus.

32. The method of claim 31 further comprising:

removing the staple from the apparatus after the distal portions of the legs are implanted.

33. The method of claim 32 further comprising:

pushing the staple further into the anatomical feature after the staple is removed from the apparatus.

34. The method of claim 32 wherein the passage in the apparatus comprises a groove in a first surface of the apparatus, the groove comprising a first portion for receiving a backspan of the medical staple and second and third portions substantially perpendicular to the first portion for receiving proximal portions of first and second legs of the medical staple, respectively, and wherein the removing of the staple from the apparatus comprises removing the staple from the groove through the first surface of the apparatus.

35. The method of claim 34 wherein the apparatus further comprises a cover movable between a closed position in which the cover covers at least a portion of the groove in the first surface of the apparatus so as to prevent the staple from being removed from the groove and a second position in which the cover does not cover the groove so that the staple can be removed from the groove, the method further comprising:

maintaining the cover in the closed position during the pulling; and

moving the cover into the open position prior to the removing.

36. The method of claim 34 wherein the removing comprises rotating the apparatus relative to the staple about an axis substantially parallel to the second and third portions of the groove of the apparatus.

37. The method of claim 34 wherein the removing comprises:

rotating the apparatus relative to the staple about a first axis substantially collinear with the second portion of the groove to remove the second leg of the staple from the groove; and

subsequently rotating the apparatus relative to the staple about a second axis substantially parallel and not collinear with the second portion of the groove to remove the first leg of the staple from the groove.

38. The method of claim 34 wherein the removing comprises:

rotating the apparatus relative to the staple about an axis substantially parallel to the first portion of the groove of the apparatus to remove the first and second legs of the staple from the groove; and

after the rotating, pulling the apparatus away from the staple.

39. An apparatus for holding a shape memory article, the shape memory article comprising a proximal portion and a distal portion and being adapted to be implanted into an anatomical feature with the distal portion first, the apparatus comprising:

a unitary body having a passage open to an outer surface of a lateral portion of the body, the passage being shaped for receiving and retaining the proximal portion of the shape memory article, the body being configured to prevent the shape memory article from deforming in accordance with its shape memory properties when the proximal portion of the shape memory article is retained in the passage.