Medical device for use in laparoscopic surgery

• US 6,477,423 B1
• Filed: 11/15/2000
• Issued: 11/05/2002
• Est. Priority Date: 05/28/1997
• Status: Expired due to Fees

• Current Assignee: Transneuronix Inc. (Medtronic Plc)
• Original Assignee: Transneuronix Inc. (Medtronic Plc)
• Inventors: Jenkins, David A.
• Primary Examiner(s): RIVELL, JOHN A
• Application Number:
  US09/713,553
• Time in Patent Office: 720 Days
• Field of Search: 607/2, 607/40, 607/41, 607/115, 607/116, 607/125, 607/126, 607/149, 606/222, 606/223
• US Class Current: 607/40
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An improved medical implant device is provided which is designed and adapted for use in laparoscopic surgery. This medical implant device is especially adapted for precise and proper placement of the electrodes relative to the tissue to be treated. Additionally, the medical implant device, once properly placed, can be secured so as to substantially reduce the risk of displacement of the device, and especially the electrodes, during normal movement of the tissue. This medical implant device is especially adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. Generally, the implant devices of this invention have an elongated body equipped with immobilizing mechanisms or devices to secure it to the tissue or viscera to be treated and two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, a mechanism for penetration of the tissue or viscera to be treated, and a quick-release connecting device to separate the penetration device from the elongated body. The improved medical implant device of this invention is obtained by precisely controlling the relative positioning of the electrodes and the immobilizing mechanisms along the elongated body. This implant device can be easily inserted and properly placed or anchored in the viscera to be stimulated. This improved implant device includes electric poles and immobilizing components properly disposed with respect to each other to ensure effective electrostimulation and/or electrical monitoring of the tissue or viscera of the mammalian body (especially the human body), especially tissue and internal organs the endo-abdominal cavity.

Claims

1. An implant device for electrostimulation or electrical monitoring of tissue to be treated, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism attached to the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism along the elongated body to engage tissue at either end of the penetration tunnel in order to secure the implant device to the tissue to be treated, wherein the first immobilizing mechanism engages tissue outside the distal terminus and the second immobilizing mechanism engages tissue at the proximal terminus of the penetration tunnel, (5) at least a first and second electric poles located between the first and second immobilizing mechanisms, wherein the first and second electric poles are in good electrical contact with tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source;

wherein the first and second electric poles are electrically connected to the electrical connection terminal;

wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; and

wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

2. The implant device as described in claim 1, wherein the first immobilizing mechanism comprises about 1 to about 4 suture holes.

3. The implant device as described in claim 1, wherein second immobilizing mechanism is a set of flexible and angled tines which form an acute angle with the elongated body in the direction of the at least first and second electric poles.

4. The implant device as described in claim 2, wherein second immobilizing mechanism is a first set of flexible and angled tines which form an acute angle with the elongated body in the direction of the at least first and second electric poles.

5. The implant device as described in claim 1 further comprising a third immobilizing mechanism located along the elongated body between the first immobilizing mechanism and the at least first and second electric poles, wherein the third immobilizing mechanism engages tissue outside the distal terminus of the penetration tunnel.

6. The implant device as described in claim 2 further comprising a third immobilizing mechanism located along the elongated body between the first immobilizing mechanism and the at least first and second electric poles, wherein the third immobilizing mechanism engages tissue outside the distal terminus of the penetration tunnel.

7. The implant device as described in claim 3 further comprising a third immobilizing mechanism located along the elongated body between the first immobilizing mechanism and the at least first and second electric poles, wherein the third immobilizing mechanism engages tissue outside the distal terminus of the penetration tunnel.

8. The implant device as described in claim 3 further comprising a third immobilizing mechanism located along the elongated body between the first immobilizing mechanism and the at least first and second electric poles, wherein the third immobilizing mechanism engages tissue outside the distal terminus of the penetration tunnel.

9. The implant device as described in claim 4 further comprising a third immobilizing mechanism located along the elongated body between the first immobilizing mechanism and the at least first and second electric poles, wherein the third immobilizing mechanism engages tissue outside the distal terminus of the penetration tunnel.

10. The implant device as described in claim 3, wherein the third immobilizing mechanism is a second set of flexible and angled tines which form an acute angle with the elongated body in the direction of the at least first and second electric poles.

11. The implant device as described in claim 4, wherein the third immobilizing mechanism is a second set of flexible and angled tines which form an acute angle with the elongated body in the direction of the at least first and second electric poles.

12. The implant device as described in claim 3, wherein the third immobilizing mechanism is a clamp to be attached to the elongated body between the first immobilizing mechanism and the at least first and second electric poles once the implant device is properly positioned.

13. The implant device as described in claim 4, wherein the third immobilizing mechanism is a clamp to be attached to the elongated body between the first immobilizing mechanism and the at least first and second electric poles once the implant device is properly positioned.

14. The implant device as described in claim 2, wherein the penetration mechanism is attached to the distal end in a detachable manner.

15. The implant device as described in claim 14, wherein the penetration mechanism is a curved stylet wherein the curved portion is of length L₂ and forms an angle θ

with the elongated body in the direction of the distal end of the elongated body and wherein the angle θ

is less than about 45°

.

16. The implant device as described in claim 15, wherein the angle θ

is between about 20° and

about 25°

.

17. The implant device as described in claim 15, wherein the length L₂ of the curved portion is less than a length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

18. The implant device as described in claim 16, wherein the length L₂ of the curved portion is less than a length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

19. The implant device as described in claim 17, wherein L₂ is about 75 to about 85 percent of L₁.

20. The implant device as described in claim 18, wherein L₂ is about 75 to about 85 percent of L₁.

21. An implant device for electrostimulation or electrical monitoring of tissue to be treated, said implant device comprising (1) an elongated body having a distal end and a proximal end, (2) a penetration mechanism attached to the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus, (3) a quick release connecting mechanism adjacent to the penetration mechanism, (4) a first immobilizing mechanism and a second immobilizing mechanism along the elongated body to engage tissue at either end of the penetration tunnel in order to secure the implant device to the tissue to be treated, wherein the first immobilizing mechanism engages tissue outside the distal terminus and the second immobilizing mechanism engages tissue at the proximal terminus of the penetration tunnel, (5) at least a first and second electric poles located between the first and second immobilizing mechanisms, wherein the first and second electric poles are in good electrical contact with tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source;

wherein the first and second electric poles are electrically connected to the electrical connection terminal;

wherein the quick release connecting mechanism is effective to separate the penetration device from the elongated body once the implant device is properly positioned in the endo-abdominal cavity; and

wherein the penetration mechanism is detachably attached to the distal end of the elongated body.

22. The implant device described in claim 21, wherein the penetration mechanism comprises a curved stylet wherein the curved portion is of length L₂ and forms an angle θ

with the elongated body in the direction of the distal end of the elongated body and wherein the angle θ

is less than about 45°

.

23. The implant device as described in claim 22, wherein the angle θ

is between about 15° and

about 30°

.

24. The implant device as described in claim 22, wherein the angle θ

is between about 20° and

about 25°

.

25. The implant device as described in claim 22, wherein the length L₂ of the curved portion is less than a length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

26. The implant device as described in claim 23 wherein the length L₂ of the curved portion is less than a length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

27. The implant device as described in claim 25, wherein L₂ is about 60 to about 90 percent of L₁.

28. The implant device as described in claim 26, wherein L₂ is about 60 to about 90 percent of L₁.

29. The implant device as described in claim 25, wherein L₂ is about 75 to about 85 percent of L₁.

30. The implant device as described in claim 26, wherein L₂ is about 75 to about 85 percent of L₁.

31. The implant device as described in claim 22, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

32. The implant device as described in claim 24, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

33. The implant device as described in claim 25, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

34. The implant device as described in claim 26, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

35. The implant device as described in claim 29, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

36. The implant device as described in claim 30, wherein the first immobilizing mechanism comprises at least one suture hole through the elongated body whereby, once the implant device is properly positioned in the endo-abdominal cavity, the distal end of the implant device can be sutured to tissue outside the distal terminus using at least one suture hole.

37. A penetration mechanism for use with an implant device for electrostimulation of tissue comprising (1) an elongated body having a distal end and a proximal end, (2) the penetration mechanism which is attached to the distal end to penetrate the tissue to be treated and to form a penetration tunnel though the tissue, wherein the penetration tunnel has a distal terminus and a proximal terminus, (3) a first immobilizing mechanism and a second immobilizing mechanism along the elongated body to engage tissue at either end of the penetration tunnel in order to secure the implant device to the tissue to be treated, wherein the first immobilizing mechanism engages tissue outside the distal terminus and the second immobilizing mechanism engages tissue at the proximal terminus of the penetration tunnel, (4) at least a first and second electric poles located between the first and second immobilizing mechanisms, wherein the first and second electric poles are in good electrical contact with tissue forming the penetration tunnel, and (6) an electrical connection terminal at the proximal end for connection to a power source, wherein the first and second electric poles are electrically connected to the electrical connection terminal, said penetration mechanism comprising a curved stylet wherein the curved portion is of length L₂and forms an angle θ

with the elongated body in the direction of the distal end of the elongated body and wherein the angle θ

is less than about 45°

.

38. The penetration mechanism as described in claim 37, wherein the penetration mechanism is detachably attached to the distal end.

39. The penetration mechanism as described in claim 38, wherein the angle θ

is between about 15° and

about 30°

.

40. The penetration mechanism as described in claim 39, wherein the angle θ

is between about 20° and

about 25°

.

41. The penetration mechanism as described in claim 38, wherein the length L₂ of the curved portion is less than the length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

42. The penetration mechanism as described in claim 40, wherein the length L₂ of the curved portion is less than the length L₁ defined by the linear extent of the at least first and second electric poles along the elongated body.

43. The penetration mechanism as described in claim 41, wherein L₂ is about 60 to about 90 percent of L₁.

44. The penetration mechanism as described in claim 42, wherein L₂ is about 60 to about 90 percent of L₁.

45. The penetration mechanism as described in claim 43, wherein L₂ is about 75 to about 85 percent of L₁.

46. The penetration mechanism as described in claim 44, wherein L₂ is about 75 to about 85 percent of L₁.