Medical device for use in laparoscopic surgery

• US 6,381,495 B1
• Filed: 01/10/2000
• Issued: 04/30/2002
• 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): LAYNO, CARL HERNANDZ
• Application Number:
  US09/480,727
• Time in Patent Office: 841 Days
• Field of Search: 607/2, 607/40, 607/41, 607/115, 607/116, 607/125, 607/126, 607/149, 606/223, 606/222
• 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 for laparoscopic surgery is especially adapted for precise and proper placement of electrode leads relative to tissue to be treated. Once properly placed, the device and the electrode leads can be secured to substantially reduce the risk of displacement during normal movement of tissue. The implant device is adapted for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. The device comprises: 1) an elongated body with immobilizing mechanisms or devices to secure it to the tissue or viscera to be treated, 2) two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, 3) a mechanism for penetration of the tissue or viscera to be treated, and 4) a quick-release connecting device to separate the penetration device from the elongated body. A unique arrangement of immobilizing mechanisms and poles along the lead body permits easy insertion and placement of the device, and ensures effective electrostimulation and/or electrical monitoring of tissue, viscera, and internal organs of a person (or other mammal'"'"'s) endo-abdominal cavity.

Claims

1. An implant device for electrostimulation or electrical monitoring of tissue to be treated within a body cavity, said implant device comprising

(1) an elongated body having a distal end and a proximal end,

(2) a penetration mechanism at the distal end to penetrate the tissue to be treated,

(3) a quick release connecting mechanism adjacent to the penetration mechanism,

(4) a first immobilizing mechanism and a second immobilizing mechanism adjacent and proximal to the quick release connecting mechanism to secure the implant device to the tissue to be treated wherein the first and second immobilizing mechanisms are spaced apart along the elongated body a distance sufficient to span the tissue such that the first immobilizing mechanism is located between the quick release connecting mechanism and the second immobilizing mechanism,

(5) a first and second electric poles located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism, 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 body cavity; and

wherein the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole.

2. The implant device as defined in claim 1, the distance from the first immobilizing mechanism to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is about 5 to 15 mm.

3. The implant device as defined in claim 2, wherein the first and second immobilizing mechanisms are sets of flexible and angled tines, such that the tines of the first immobilizing mechanism form an acute angle relative to the first electric pole and the tines of the second immobilizing mechanism form an acute angle relative to the second electric pole.

4. The implant device as defined in claim 2, wherein the first immobilizing mechanism is a clamp to be attached to the elongated body once the implant device is properly positioned in the endo-abdominal cavity and the second immobilizing mechanism is a set of flexible and angled tines, such that the tines form an acute angle relative to the second electric pole.

5. The implant device as defined in claim 4, wherein the elongated body has at least one position adapted to accept the clamp.

6. The implant device as defined in claim 2, wherein the first immobilizing mechanism is a first clamp to be attached to the elongated body once the implant device is properly positioned in the endo-abdominal cavity and the second immobilizing mechanism is a second clamp to be attached to the elongated body either before or after the implant device is properly positioned in the endo-abdominal cavity.

7. The implant device as defined in claim 4, wherein the elongated body has at least one position adapted to accept the first clamp.

8. An implant device for electrostimulation or electrical monitoring of tissue to be treated within the endo-abdominal cavity, said implant device comprising

(1) an elongated body having a distal end and a proximal end,

(2) a penetration mechanism at 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 and a length as measured from the distal terminus to the proximal terminus through the penetration tunnel,

(3) a quick release connecting mechanism adjacent to the penetration mechanism,

(4) a first immobilizing mechanism and a second immobilizing mechanism, wherein the second immobilizing mechanism is attached to, and integral, with the elongated body and is proximal to the quick release connecting mechanism such that second immobilizing unit will engage the proximal terminus of the penetration tunnel and wherein the first immobilizing mechanism is adapted to be affixed to the elongated body as its exits the distal terminus of the penetration tunnel to secure the implant device to the tissue to be treated,

(5) a first and second electric poles located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism and wherein the first and second electric poles are in good electrical contact with the 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;

wherein the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel.

9. The implant device as defined in claim 8, wherein the distance from the first immobilizing unit to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is about 5 to about 15 mm.

10. The implant device as defined in claim 8, wherein the second immobilizing mechanism is a set of flexible and angled tines, such that the tines form an acute angle relative to the second electric pole, and wherein the elongated body has at least one position adapted to accept the first immobilizing mechanism.

11. The implant device as defined in claim 9, wherein the second immobilizing mechanism is a set of flexible and angled tines, such that the tines form an acute angle relative to the second electric pole, and wherein the elongated body has at least one position adapted to accept the first immobilizing mechanism.

12. The implant device as defined in claim 8, wherein the penetration mechanism has spaced-apart markings to visually assist and guide a surgeon as the penetration tunnel is formed.

13. An implant device for electrostimulation or electrical monitoring of tissue to be treated within the endo-abdominal cavity, said implant device comprising

(1) an elongated body having a distal end and a proximal end,

(2) a penetration mechanism at 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 and a length as measured through the penetration tunnel from the proximal terminus to the distal terminus,

(3) a quick release connecting mechanism adjacent to the penetration mechanism,

(4) a first immobilizing mechanism which can be attached to the elongated body to secure it in place within the penetration tunnel once the elongated body is properly positioned relative to the tissue to be treated and a second immobilizing mechanism which can be attached to the elongated body to secure it in place within the penetration tunnel either before or after the elongated body is properly positioned relative to the tissue to be treated, wherein the first immobilizing mechanism is adapted to be attached to the elongated body at the distal terminus of the penetration tunnel and the second immobilizing mechanism is adapted to be attached to the elongated body at the proximal terminus of the penetration tunnel,

(5) a first electric pole and a second electric pole spaced apart along the elongated body to be contained within the penetration tunnel and to be in good electrical contact with the 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;

wherein, when the first and second electric poles are properly situated within the penetration tunnel, the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel.

14. The implant device as defined in claim 13, wherein the distance from the first immobilizing mechanism to the first electric pole is about 5 to about 20 mm and the distance from the second immobilizing mechanism to the second electric pole is about 5 to about 15 mm.

15. The implant device as defined in claim 14, wherein the first immobilizing mechanism is a first clamp.

16. The implant device as defined in claim 15, wherein the second immobilizing mechanism is a second clamp.

17. The implant device as defined in claim 15, wherein the elongated body has at least one clamping position adapted to accept the first clamp.

18. The implant device as defined in claim 17, wherein the elongated body has at least one clamping position adapted to accept the second clamp.

19. A laparoscopic surgical method for attaching an implant device to tissue to be treated, said method comprising

(a) inserting an implant device though a trocar into a body cavity containing the tissue to be treated, wherein the implant device has a penetration mechanism and a first and second electric poles,

(b) forming a penetration tunnel within the tissue to be treated using the penetration mechanism, wherein the penetration tunnel has a distal terminus and a proximal terminus and a length as measured through the penetration tunnel from the proximal terminus to the distal terminus,

(c) positioning the first and second electric poles within the penetration tunnel to provide good electrical contact with the tissue to be treated, and

(d) immobilizing the implant device within the penetration tunnel so as to maintain good electrical contact between the first electric pole and the tissue to be treated and between the second electric pole and the tissue to be treated during a treatment regime;

wherein the implant device comprises

(1) an elongated body having a distal end and a proximal end,

(2) penetration mechanism which is located at the distal end to penetrate and to form the penetration tunnel in the tissue to be treated,

(3) a quick release connecting mechanism adjacent to the penetration mechanism,

(4) a first immobilizing mechanism and a second immobilizing mechanism adjacent and proximal to the quick release connecting mechanism to immobilize the implant device to the tissue to be treated wherein the first and second immobilizing mechanisms are spaced apart along the elongated body a distance sufficient to span the tissue such that the first immobilizing mechanism is located between the quick release connecting mechanism and the second immobilizing mechanism,

(5) first and second electric poles which are located between the first and second immobilizing mechanisms, such that the first electric pole is adjacent to the first immobilizing mechanism and the second electric pole is adjacent to the second immobilizing mechanism, 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 first and second electric poles are properly positioned within the penetration tunnel; and

wherein, when the first and second electric poles are properly situated within the penetration tunnel, the first immobilizing mechanism is located at a distance of about 5 mm or greater from the first electric pole and the second immobilizing mechanism is located at a distance of about 5 mm or greater from the second electric pole, and wherein the first and second immobilizing mechanism are spaced apart a distance approximately equal to, or less than, the length of the penetration tunnel.

20. The method as defined in claim 19, wherein distance from the first immobilizing mechanism to the first electric pole is about 5 to about 20 mm from the first electric pole and the distance from the second immobilizing mechanism to the second electric pole is about 5 mm to about 15 mm from the second electric pole.

21. The method as defined in claim 20, wherein the first and second immobilizing mechanisms are sets of flexible and angled tines, such that the tines of the first immobilizing mechanism form an acute angle relative to the first electric pole and the tines of the second immobilizing mechanism form an acute angle relative to the second electric pole.

22. The method as defined in claim 20, wherein the first immobilizing mechanism is a clamp to be attached to the elongated body once the implant device is properly positioned in the penetration tunnel and the second immobilizing mechanism is a set of flexible and angled tines, such that the tines form an acute angle relative to the second electric pole.

23. The method as defined in claim 22, wherein the elongated body has at least one position adapted to accept the clamp.

24. The method as defined in claim 20, wherein the first immobilizing mechanism is a first clamp to be attached to the elongated body once the implant device is properly positioned in the penetration tunnel and the second immobilizing mechanism is a second clamp to be attached to the elongated body either before or after the implant device is properly positioned in the penetration tunnel.

25. The method as defined in claim 24, wherein the elongated body has at least one position adapted to accept the first clamp.

26. A method for electrostimulation of gastrointestinal tissue, said method comprising

(a) inserting an implant device though a trocar into the endo-adominal cavity, wherein the implant device has a first and second electric poles and an electrical connection terminal for connection to an electrical pulse generator,

(b) positioning the first and second electric poles within an area of the gastrointestinal track to provide good electrical stimulation with the Auerbach plexus and the Meissner plexus,

(c) immobilizing the implant device so as to maintain good electrical stimulation of the Auerbach plexus and the Meissner plexus during a treatment regime,

(d) attaching the electrical pulse generator to the electrical connection terminal of the implant device, and

(e) delivering electrical impulses to the implant device and thereby electrically stimulating the Auerbach plexus and the Meissner plexus.

27. The method as defined in claim 26, wherein the gastrointestinal tissue to be treated is stomach tissue.