Method and system for non-vascular sensor implantation

• US 7,025,760 B2
• Filed: 12/27/2001
• Issued: 04/11/2006
• Est. Priority Date: 09/07/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Miller, Michael E.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/034,627
• Publication Number:
  US 20030078560A1
• Time in Patent Office: 1,566 Days
• Field of Search: 623/1.1, 623/1.12, 623/1.15, 623/11.11, 623/14.13, 623/23.72, 604/65, 604/66, 604/67, 128/DIG.11, 128/DIG.12, 404/288.01, 404/288.02, 404/288.03, 404/288.04, 404/93.01, 404/890.1, 404/891.1
• US Class Current: 604/891.1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A method and system for non-vascular sensor implantation. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the area of the implant unit. The sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area of the body. A subcutaneous area of the body may be tunneled to place the sensor. The system may include an implant unit such as, for example, for delivering drug to a human body and a sensor for detecting a physiological parameter. The sensor may be separate from and connectable to the implant unit and may be placed in a non-vascular area of the human body.

Claims

1. A method for non-vascular implant of a sensor comprising:

incising an area of a body large enough for inserting an implant unit;

incising an area remote from a sensor location for inserting a sensor;

directing the sensor into a body cavity, disposing the sensor in a location remote from an incision through which the sensor is directed without passing the sensor through a vascular system;

connecting the sensor to the implant unit; and

inserting the implant unit into the body.

2. A method of claim 1, further comprising:

allowing a foreign body capsule to form around the area of the implant unit.

3. The method of claim 2, further comprising placing a material around the implant unit for promoting growth characteristics.

4. The method of claim 2, wherein the implant unit comprises electronics.

5. The method of claim 2, wherein the implant unit comprises a pump.

6. The method of claim 2, wherein allowing a foreign body capsule to form comprises inserting materials around the implant unit to promote growth characteristics.

7. The method of claim 2, wherein incising an area remote from a sensor location comprises incising an area of the body large enough for the sensor.

8. The method of claim 7, wherein the incised area of the body large enough for the sensor is smaller than an incised area of the body large enough for the implant inserting unit.

9. The method of claim 1, wherein inserting the implant unit into the body comprises inserting the implant unit into a pocket formed when incising an area of the body large enough for inserting the implant unit.

10. The method of claim 1, further comprising fixing the sensor in place using suture.

11. The method of claim 1, wherein incising an area remote from a sensor location comprises creating a tunnel extending from the area incised for inserting the implant unit.

12. The method of claim 11, wherein connecting the sensor to the implant unit comprises extending electrical leads through the tunnel.

13. The method of claim 1, wherein incising an area remote from a sensor location comprises tunneling an introducer from the area incised for inserting the implant unit, through subcutaneous tissue, to an area remote from the area incised for inserting the implant unit.

14. The method of claim 13, wherein connecting the sensor to the implant unit comprises extending electrical leads through a tunnel formed in the subcutaneous tissue by said tunneling.

15. A non-vascular implant system comprising:

an implant unit configured to be implanted in a first area of a patient'"'"'s body;

a sensor for detecting a physiological parameter, the sensor being separate from and connectable to the implant unit, the sensor being configured to be disposed in a second area of a patient'"'"'s body remote from the first area of the patient'"'"'s body, and

a tool for creating a subcutaneous tunnel from the first area of the patient'"'"'s body to the second area of the patient'"'"'s body;

wherein the sensor is configured to be placed in the second area of the human body by passing the sensor through the tunnel without passing the sensor through a vascular system, and

wherein the sensor is configured to be connected to the implant unit after the implant unit is implanted in the human body.

16. The system of claim 15, wherein the implant unit comprises a pump.

17. The system of claim 15, wherein the implant unit comprises electronics.

18. The system of claim 15, wherein the implant unit delivers drug to a human body.

19. The system of claim 18, wherein the drug is insulin.

20. The system of claim 15, wherein the sensor comprises a biomolecule.

21. The system of claim 15, wherein the sensor comprises a lead.

22. The system of claim 15, wherein the sensor comprises a sensing element.

23. The system of claim 22, wherein the sensing element is a biomolecule.

24. The system of claim 23, wherein the biomolecule is a glucose oxidase enzyme.

25. The system of claim 15, wherein the physiological parameter is oxygen.

26. The system of claim 15, wherein the physiological parameter is glucose.

27. The system of claim 15, wherein the non-vascular area of the human body is the peritoneum.

28. The system of claim 15, wherein the non-vascular area of the human body is subcutaneous tissue.

29. A method for non-vascular implant of a sensor comprising:

incising an area of a body large enough for inserting an implant unit;

creating a tunnel in subcutaneous tissue;

directing the sensor through the tunnel;

connecting the sensor to the implant unit; and

inserting the implant unit into the body.

30. The method of claim 29, wherein the tunnel is created using a blunt instrument.

31. The method of claim 29, wherein the blunt instrument causes minimal trauma to the subcutaneous tissue.

32. The method of claim 29, wherein the blunt instrument is a trocar.

33. A method as recited in claim 29, further comprising:

allowing a foreign body capsule to form around the implant unit.