Reusable analyte sensor site and method of using the same

• US 20030220552A1
• Filed: 02/12/2003
• Published: 11/27/2003
• Est. Priority Date: 07/01/1999
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Miller, Michael E., Van Antwerp, William P., Enegren, Bradley J., Gottlieb, Rebecca, Reghabi, Bahar, Mastrototaro, John J., Van Antwerp, Nannette M., Jin, Eunjoo
• Granted Patent: US 7,247,138 B2
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte includes a site housing material and a resealable insertion site coupled to one end of the site housing material. Preferably, the site housing material is formed to have an interior cavity with an opening. The site housing material is selected to promote tissue ingrowth and vascularization, and yet be free of tissue ingress. Also, the site housing material permits the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site provides a for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

Claims

1. A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte in a patient, the site comprising:

a site housing material formed to have an interior cavity with an opening, wherein the site housing material is selected to promote tissue ingrowth and vascularization and be free of tissue ingress, and wherein the site housing material permits fluid including the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor; and

a resealable insertion site coupled to one end of the site housing material for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

2. A site according to claim 1, wherein the resealable insertion site includes:

a tube coupled to one end of the site housing material; and

a sealing member having a resealable opening, wherein the tube is coupled between the site housing material and the sealing member;

wherein the replaceable analyte sensor is inserted through the resealable opening, and the resealable opening is sealed upon placement of the replaceable analyte sensor within the interior cavity of the site housing material.

3. A site according to claim 2, wherein the sealing member is a suture disc for attaching the tube to body tissue of the patient.

4. A site according to claim 3, wherein the tube and the suture disc are combined into an integral unit.

5. A site according to claim 3, further comprising another suture disc coupled to the other end of the site housing material for attaching the other end of the site housing material to the body tissue of the patient.

6. A site according to claim 1, wherein the sealing member is a sewing cuff for attaching the tube to body tissue of the patient.

7. A site according to claim 2, wherein the resealable opening is sealed using a compression seal.

8. A site according to claim 7, wherein the tube has a smaller size than the sealing member such that the tube compresses the sealing member within the tube and seals the resealable opening around the replaceable analyte sensor.

9. A site according to claim 7, wherein the resealable insertion site further includes a ring placed over the sealing member to compress and seal the resealable opening around the replaceable analyte sensor.

10. A site according to claim 7, wherein a cross-cut is formed in the sealing member at the resealable opening.

11. A site according to claim 2, wherein the resealable opening is sealed using a mechanical seal.

12. A site according to claim 11, wherein the resealable insertion site further includes a Touhy-Borst placed over the sensor to lock the replaceable analyte sensor into the resealable opening.

13. A site according to claim 11, wherein the resealable insertion site further includes a replaceable septum placed over the sensor and the resealable opening.

14. A site according to claim 1, wherein the sensor site is adapted for connection to an injection site for delivering fluids into the site housing material.

15. A site according to claim 1, wherein the site housing material is for implantation into inter-peritoneal tissue of the patient, and the resealable insertion site is for implantation into subcutaneous tissue of the patient.

16. A site according to claim 1, wherein the site housing material is selected from a group of materials consisting essentially of polytetra fluoroethylene, porous polyurethane, porous silicone, and silicone foam.

17. A site according to claim 1, wherein the site housing will last for a period of time such that it can be used with two or more consecutive replaceable analyte sensors.

18. A site according to claim 1, wherein the site housing material passes glucose, and wherein the replaceable analyte sensor is a glucose sensor.

19. A site according to claim 1, wherein the interior cavity has a predetermined size to inhibit stagnation of the fluid including the analyte within the interior cavity.

20. A system for measuring analyte in a body of a patient, the system comprising:

a replaceable analyte sensor for determining a level of an analyte; and

a reusable analyte sensor site including;

a site housing material formed to have an interior cavity with an opening, wherein the site housing material is selected to promote tissue ingrowth and vascularization and be free of tissue ingress, and wherein the site housing material permits fluid including the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor; and

a resealable insertion site coupled to the site housing material for inserting the replaceable analyte sensor into the interior cavity of the site housing material.

21. A system according to claim 20, wherein the resealable insertion site includes:

a tube coupled to one end of the site housing material; and

a sealing member having a resealable opening, wherein the tube is coupled between the site housing material and the sealing member;

wherein the replaceable analyte sensor is inserted through the resealable opening, and the resealable opening is sealed upon placement of the replaceable analyte sensor within the interior cavity of the site housing material.

22. A system according to claim 21, wherein the sealing member is a suture disc for attaching the tube to body tissue of the patient.

23. A system according to claim 22, wherein the tube and the suture disc are combined into an integral unit.

24. A system according to claim 22, wherein the reusable analyte sensor site further includes another suture disc coupled to the other end of the site housing material for attaching the other end of the site housing material to the body tissue of the patient.

25. A system according to claim 21, wherein the sealing member is a sewing cuff for attaching the tube to body tissue of the patient.

26. A system according to claim 21, wherein the resealable opening is sealed using a compression seal.

27. A system according to claim 26, wherein the tube has a smaller size than the sealing member such that the tube compresses the sealing member within the tube and seals the resealable opening around the replaceable analyte sensor.

28. A system according to claim 26, wherein the resealable insertion site further includes a ring placed over the sealing member to compress and seal the resealable opening around the replaceable analyte sensor.

29. A system according to claim 26, wherein a cross-cut is formed in the sealing member at the resealable opening.

30. A system according to claim 21, wherein the resealable opening is sealed using a mechanical seal.

31. A system according to claim 30, wherein the resealable insertion site further includes a Touhy-Borst placed over the sensor to lock the replaceable analyte sensor into the resealable opening.

32. A system according to claim 30, wherein the resealable insertion site further includes a replaceable septum placed over the sensor and the resealable opening.

33. A system according to claim 20, wherein the reusable analyte sensor site is adapted for connection to an injection site for delivering fluids into the site housing material.

34. A system according to claim 20, wherein the site housing material is for implantation into inter-peritoneal tissue of the patient, and the resealable insertion site is for implantation into subcutaneous tissue of the patient.

35. A system according to claim 20, wherein the site housing material is selected from a group of materials consisting essentially of polytetra fluoroethylene, porous polyurethane, porous silicone, and silicone foam.

36. A system according to claim 20, wherein the site housing will last for a period of time such that it can be used with two or more consecutive replaceable analyte sensors.

37. A system according to claim 20, wherein the site housing material passes glucose, and wherein the replaceable analyte sensor is a glucose sensor.

38. A system according to claim 20, wherein the interior cavity has a predetermined size to inhibit stagnation of the fluid including the analyte within the interior cavity.

39. A reusable analyte sensor site for use with a replaceable analyte sensor for determining a level of an analyte, the site comprising:

a site housing material formed to have an interior cavity with an opening, wherein the site housing material is selected to promote tissue ingrowth and vascularization and be free of tissue ingress, wherein the site housing material permits fluid including the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor, and wherein the interior cavity has a predetermined size to inhibit stagnation of the fluid including the analyte within the interior cavity.

40. A site according to claim 39, wherein the site housing material has a porosity in a range from 2 to 25 microns.

41. A site according to claim 39, wherein the site housing is for implantation into sub-dermal tissue.

42. A site according to claim 39, wherein the site housing is for implantation into inter-peritoneal tissue.

43. A site according to claim 39, wherein the site housing material is selected from a group of materials consisting essentially of Teflon and Dacron.

44. A site according to claim 39, wherein the site housing will last for a period of time such that it can be used with two or more consecutive replaceable analyte sensors.

45. A site according to claim 39, wherein the site housing material passes glucose, and wherein the replaceable analyte sensor is a glucose sensor.

46. A system for measuring analyte in a body of a user, the system comprising:

a replaceable analyte sensor for determining a level of an analyte; and

a reusable analyte sensor site made from a site housing material formed to have an interior cavity with an opening, wherein the site housing material is selected to promote tissue ingrowth and vascularization and be free of tissue ingress, wherein the site housing material permits fluid including the analyte to pass through the site housing material to the interior cavity to permit measurement by the replaceable analyte sensor, and wherein the interior cavity has a predetermined size to inhibit stagnation of the fluid including the analyte within the interior cavity.

47. A system according to claim 46, wherein the site housing material has a porosity in a range from 2 to 25 microns.

48. A system according to claim 46, wherein the reusable analyte sensor site is for implantation into sub-dermal tissue.

49. A system according to claim 46, wherein the reusable analyte sensor site is for implantation into inter-peritoneal tissue.

50. A system according to claim 46, wherein the reusable analyte sensor site housing material is selected from a group of materials consisting essentially of Teflon and Dacron.

51. A system according to claim 46, wherein the reusable analyte sensor site will last for a period of time such that it can be used with two or more consecutive replaceable analyte sensors.

52. A system according to claim 46, wherein the site housing material passes glucose, and wherein the replaceable analyte sensor is a glucose sensor.