Method and system for non-vascular sensor implantation

• US 8,506,550 B2
• Filed: 11/24/2005
• Issued: 08/13/2013
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Miller, Michael E., Shah, Rajiv
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US11/286,471
• Publication Number:
  US 20060079858A1
• Time in Patent Office: 2,819 Days
• Field of Search: 623/1.1, 623/1.12, 623/1.15, 623/11.11, 623/14.13, 623/23.72, 604 65- 67, 604/93.01, 604/890.1, 604/500, 128/DIG.11, 128/DIG.12, 404/288.01, 404/288.02, 404/288.03, 404/288.04
• US Class Current: 604/500
• 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 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6882 Anchoring means
• 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
• CPC Class Codes: H05K 3/4061 for via connections in inorganic insulating substrates

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 and an implant unit that provides a medical treatment, the method comprising:

implanting an implant unit in an area of a body without passing the implant unit through a vascular system, the implant unit configured to provide a medical treatment to the body at least partially dependent upon signals provided by the sensor;

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

directing the sensor into the foreign body capsule; and

connecting the sensor to the implant unit subsequent to formation of the foreign body capsule.

2. The method of claim 1, wherein implanting an implant unit comprises incising an area of the body large enough for the implant unit.

3. The method of claim 1, further comprising placing a material around the implant unit for promoting growth characteristics.

4. The method of claim 1, wherein the implant unit comprises electronics.

5. The method of claim 1, wherein the implant unit comprises a pump.

6. The method of claim 1, wherein allowing a foreign body capsule to form comprises inserting materials around the implant unit to promote growth characteristics.

7. The method of claim 1, further comprising attaching the sensor to the implant unit.

8. The method of claim 7, wherein the sensor is attached to the implant unit prior to formation of the foreign body capsule.

9. The method of claim 7, wherein the sensor is attached to the implant unit subsequent to formation of the foreign body capsule.

10. The method of claim 1, further comprising incising an area of the body large enough for the sensor.

11. The method of claim 10, 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 unit.

12. The method of claim 1, wherein:

implanting an implant unit comprises forming a pocket in tissue of the body, introducing the implant unit into the pocket and closing the pocket;

allowing a foreign body capsule to form comprises allowing sufficient time to pass after closing the pocket for a foreign body capsule to form naturally around the implant unit; and

directing the sensor into the foreign body capsule comprises making an incision into the pocket, introducing the sensor through the incision and into the foreign body capsule and closing the incision.

13. The method of claim 12, wherein the implant unit comprises an insulin delivery device and the sensor comprises at least one of a blood glucose level sensor and a blood oxygen level sensor.

14. The method of claim 12, wherein connecting the sensor to the implant unit comprises connecting an electrical connector associated with sensor to an electrical connector associated with the implant unit before closing the incision.

15. The method of claim 1, further comprising disposing at least one foreign body capsule sensor in the body, in a vicinity of the pocket to sense the formation of a foreign body capsule.

16. The method of claim 15, wherein the at least one foreign body capsule sensor comprises an oxygen sensor.

17. The method of claim 15, further comprising removing the at least one foreign body capsule sensor from the body after allowing a foreign body capsule to form.

18. The method of claim 1, wherein the implant unit comprises an insulin delivery device and the sensor comprises at least one of a blood glucose level sensor and a blood oxygen level sensor.

19. The method of claim 1, wherein allowing a foreign body capsule to form comprises awaiting a period of time sufficient to allow a foreign body capsule to form naturally around the implant unit and operating the implant unit in an open loop arrangement during the period of time in which the foreign body capsule is being formed.

20. The method of claim 19, further comprising operating the implant unit in a closed loop arrangement with feedback from the sensor, after connecting the sensor to the implant unit.

21. A method for non-vascular implant of a sensor and an implant unit that provides a medical treatment, the method comprising:

implanting an implant unit in a body cavity, the implant unit configured to provide a medical treatment to the body at least partially dependent upon signals provided by the sensor;

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

directing the sensor into the foreign body capsule; and

connecting the sensor to the implant unit subsequent to formation of the foreign body capsule.

22. The method of claim 21, wherein:

implanting an implant unit comprises forming a pocket in tissue of the body, introducing the implant unit into the pocket and closing the pocket;

allowing a foreign body capsule to form comprises allowing sufficient time to pass after closing the pocket for a foreign body capsule to form naturally around the implant unit; and

directing the sensor into the foreign body capsule comprises making an incision into the pocket, introducing the sensor through the incision and into the foreign body capsule and closing the incision.

23. The method of claim 22, wherein the implant unit comprises an insulin delivery device and the sensor comprises at least one of a blood glucose level sensor and a blood oxygen level sensor.

24. The method of claim 22, wherein connecting the sensor to the implant unit comprises connecting an electrical connector associated with sensor to an electrical connector associated with the implant unit before closing the incision.

25. The method of claim 21, further comprising disposing at least one foreign body capsule sensor in the body, in a vicinity of the pocket to sense the formation of a foreign body capsule.

26. The method of claim 25, wherein the at least one foreign body capsule sensor comprises an oxygen sensor.

27. The method of claim 25, further comprising removing the at least one foreign body capsule sensor from the body after allowing a foreign body capsule to form.

28. The method of claim 21, wherein the implant unit comprises an insulin delivery device and the sensor comprises at least one of a blood glucose level sensor and a blood oxygen level sensor.

29. The method of claim 21, wherein allowing a foreign body capsule to form comprises providing a material around the implant unit to promote foreign body capsule growth characteristics.

30. The method of claim 21, wherein allowing a foreign body capsule to form comprises awaiting a period of time sufficient to allow a foreign body capsule to form naturally around the implant unit and operating the implant unit in an open loop arrangement during the period of time in which the foreign body capsule is being formed.

31. The method of claim 30, further comprising operating the implant unit in a closed loop arrangement with feedback from the sensor, after connecting the sensor to the implant unit.