Apparatus and method for introducing an implant

• US 6,530,896 B1
• Filed: 07/24/2000
• Issued: 03/11/2003
• Est. Priority Date: 05/13/1996
• Status: Expired due to Fees

• Current Assignee: James B. Elliott
• Original Assignee: James B. Elliott
• Inventors: Elliott, James B.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y.
• Application Number:
  US09/624,565
• Time in Patent Office: 960 Days
• Field of Search: 604/57, 604/58, 604/59, 604/60, 604/61, 604/62, 604/63, 604/14, 604/15, 604/16, 604/311, 604/187, 604/104, 606/107
• US Class Current: 604/60
• CPC Class Codes: A61D 7/00 Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals for reproduction or fertilisation A61D19/00 ; devices for implanting pellets, radon seeds or the like A61M37/0069
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: Y10S 977/875 with tip detail

Abstract

An apparatus for introducing an implant into tissue is provided. The apparatus comprises a cartridge having proximal and distal ends, inner and outer surfaces, and a central bore extending therethrough having proximal and distal ends. An implant having proximal and distal ends is within the central bore. A piston is provided proximal to the implant and slidably maintained within the bore, whereby, during operation, the piston moves distally through the bore and urges the implant distally through the bore. The distal end of the cartridge includes a pressure-activated tip section enclosing the distal end of the bore. The bore is enclosed such that sterility of the implant within the bore can be maintained until the implant is released from the cartridge into the patient.

Claims

1. An apparatus for introducing an implant into tissue comprising:

a cartridge having proximal and distal ends, inner and outer surfaces, and a central bore extending therethrough having proximal and distal ends;

an implant having proximal and distal ends within the central bore;

a piston proximal to the implant and slidably maintained within the bore, whereby, during operation, the piston moves distally through the bore and urges the implant distally through the bore; and

an openable tip section at the distal end of the cartridge completely enclosing the distal end of the bore and having inner and outer surfaces;

wherein, in use, when the piston is moved distally to urge the implant distally, the bore is completely enclosed until the tip section is opened.

2. An apparatus according to claim 1, wherein the tip section is segmented or frangible into a plurality of segments under pressure from the distal end of the implant, thereby allowing the implant to emerge from the cartridge.

3. An apparatus according to claim 2, wherein the tip section includes means for inducing stress fracture of the tip to create the plurality of frangible segments.

4. An apparatus according to claim 2, further comprising reinforcement means extending from the cartridge body to the segments of the tip section to prevent separation of the segments from the tip section subsequent to fracture.

5. An apparatus according to claim 1, wherein the tip section is made of a biocompatible material and is removably attached to the cartridge.

6. An apparatus according to claim 2, wherein the junction between the tip section and the cartridge is covered with a coating that reinforces the junction to prevent separation of the segments from the tip section.

7. An apparatus according to claim 6, wherein the coating covers at least a portion of the outer surface of the cartridge and at least a portion of the outer surface of the tip section.

8. An apparatus according to claim 1, wherein the piston is in contact with and maintains a seal with the inner surface of the cartridge.

9. An apparatus according to claim 1, wherein the openable tip section is pressure-activated.

10. An apparatus according to claim 1, further comprising an assist plug having proximal and distal ends within the bore, wherein the distal end of the assist plug is in contact with the inner surface of the tip section.

11. An apparatus according to claim 10, wherein the proximal end of the assist plug is in contact with the distal end of the implant.

12. An apparatus according to claim 10, wherein a portion of the assist plug is contained within the implant.

13. An apparatus according to claim 12, wherein the proximal end of the assist plug is in contact with the piston.

14. An apparatus according to claim 12, wherein the proximal end of the assist plug is fixedly attached to the piston.

15. An apparatus according to claim 10, wherein the assist plug is made of a biocompatible material.

16. An apparatus according to claim 10, wherein at least a portion of the implant is contained within the assist plug.

17. An apparatus according to claim 10, wherein the assist plug comprises:

an outer component having a hollow interior region containing at least a portion of the implant;

an inner component within the hollow interior region proximal the implant;

a compression spring mounted between the inner component and outer component;

means for moving the outer component distally and proximally within the cartridge;

means for moving the inner component distally with the outer component; and

means for preventing the inner component from separating from the outer component upon proximal movement of the outer component;

whereby, in operation, distal movement of the outer component results in distal movement of the inner component and implant so that the implant is carried outside of the bore, and the spring maintains the position of the inner component upon proximal movement of the outer component until the implant is uncovered by the outer component to prevent unintentional withdrawal of the implant back into the cartridge.

18. An apparatus according to claim 17, wherein the means for moving the inner component distally with the outer component comprises a proximally-facing surface of the inner component in contact with a distally-facing surface of the outer component.

19. An apparatus according to claim 17, wherein the means for preventing the inner component from separating from the outer component comprises:

a circumferential ridge attached to the outer component and extending within the hollow interior region; and

an inner component including a rod extending within the circumferential ridge and a shoulder proximal the ridge that is too large to pass by the ridge.

20. An apparatus according to claim 1, further comprising a plunger at the proximal end of the cartridge for pushing the piston distally through the bore.

21. An apparatus according to claim 1, wherein the cartridge is made of a flexible material.

22. An apparatus according to claim 1, wherein the tip section has a blunt, non-piercing distal end.

23. An apparatus according to claim 1, wherein the cartridge is made of a flexible material and the tip section has a blunt, non-piercing distal end, and further comprising a plunger at the proximal end of the cartridge for pushing the piston distally through bore.

24. An apparatus according to claim 1, wherein the implant is selected from the group consisting of time-release drug and gene therapy implants, implantable bone and tissue filler and adhesive materials in paste and semi-solid forms, stents, radionuclide seeds, micro-electronic and nano-mechanical chip implants, and combinations thereof.

25. An apparatus according to claim 1, comprising a plurality of implants within the bore.

28. A system for introducing an implant into tissue comprising:

an apparatus according to claim 1; and

an insertion tool for urging the piston distally through the bore.

29. A system according to claim 28, wherein the insertion tool comprises:

means for attaching the tool to the cartridge; and

means for distally moving the piston.

30. A system according to claim 29, wherein the proximal end of the plunger is within the bore when the distal end of the implant is within the bore.

31. A system according to claim 28, wherein the insertion tool comprises means for removably attaching the tool to the cartridge.

32. A system according to claim 28, wherein the insertion tool comprises means for fixedly attaching the tool to the cartridge.

33. A system according to claim 28, wherein the insertion tool is maintained within a prophylactic covering.

34. A method for introducing an implant into tissue, comprising:

providing an apparatus as recited in claim 1;

inserting at least a portion of the distal end of the cartridge into the tissue;

moving the piston distally through the bore, thereby urging the implant distally through the bore;

exerting pressure on the tip section with the implant to permit the implant to open the tip section and exit the bore.

35. A method according to claim 34, wherein the distal end of the piston is in direct contact with the proximal end of the implant.

36. A method according to claim 34, wherein the distal end of the implant is in direct contact with the inner surface of the tip section.

37. A method according to claim 34, wherein the apparatus further comprises an assist plug in contact with the implant and with the inner surface of the tip section.

38. A method according to claim 34, wherein the implant is introduced into a surgically-accessed vessel.

39. A method according to claim 34, wherein the implant is introduced into a natural body orifice.

40. A method according to claim 34, wherein the implant is introduced subcutaneously.

41. A method according to claim 34, wherein the implant is selected from the group consisting of time-release drug and gene therapy implants, implantable bone and tissue filler and adhesive materials in paste and semi-solid forms, stents, radionuclide seeds, micro-electronic and nano-mechanical chip implants, and combinations thereof.

26. An apparatus for introducing an implant into tissue comprising:

a cartridge having proximal and distal ends, inner and outer surfaces, and a central bore extending therethrough having proximal and distal ends;

an implant having proximal and distal ends within the central bore;

a piston at the proximal end of the cartridge slidably maintained within the bore that is in contact with and maintains a seal with the inner surface of the cartridge, whereby, during operation, the piston moves distally through the bore and urges the implant distally through the bore;

a pressure-activated tip section at the distal end of the cartridge completely enclosing the distal end of the bore and having inner and outer surfaces, the tip section being segmented or frangible into a plurality of segments under pressure from the distal end of the implant and including means for inducing stress fracture of the tip to create the plurality of frangible segments; and

reinforcement means extending from the cartridge body to the segments of the tip section to prevent separation of the segments from the tip section subsequent to fracture;

wherein, in use, when the piston is moved distally to urge the implant distally, the bore is completely enclosed until the tip section is fractured.

27. An apparatus according to claim 26, further comprising an assist plug made of a biocompatible material having proximal and distal ends within the bore, wherein the distal end of the assist plug is in contact with the inner surface of the tip section and the proximal end of the assist plug is in contact with the distal end of the implant.