Reusable analyte sensor site and method of using the same

• US 20040143173A1
• Filed: 06/02/2003
• Published: 07/22/2004
• 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 7,166,074 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 and a resealable insertion site coupled to one end of the site housing. Preferably, the site housing is formed to have an interior cavity, and includes an outer membrane made of a material selected to promote vascularization and having a first pore size, and an inner membrane made of a material selected to be free of tissue ingress. Also, the site housing permits the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor. The resealable insertion site is provided for inserting the replaceable analyte sensor into the interior cavity of the site housing.

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 formed to have an interior cavity and comprising;

an outer membrane being made of a material selected to promote vascularization and having a first pore size; and

an inner membrane being made of a material selected to be free of tissue ingress and having a second pore size,

wherein the site housing permits fluid including the analyte to pass through the site housing 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 for inserting the replaceable analyte sensor into the interior cavity of the site housing.

2. A site according to claim 1, wherein the first pore size of the outer membrane is larger than the second pore size of the inner membrane.

3. A site according to claim 1, wherein the second pore size of the inner membrane is larger than the first pore size of the outer membrane.

4. A site according to claim 1, wherein the outer membrane and the inner membrane are made of the same material.

5. A site according to claim 1, wherein the outer membrane and the inner membrane are made of different materials.

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

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

8. A site according to claim 1, wherein the site housing further comprises at least one intermediate membrane disposed between the outer membrane and the inner membrane and having a third pore size.

9. A site according to claim 8, wherein the third pore size is between the first pore size of the outer membrane and the second pore size of the inner membrane.

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

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

a sealing member having a resealable opening, wherein the tube is coupled between the site housing 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.

11. A site according to claim 10, wherein the sealing member is a suture disc for attaching the tube to body tissue of the patient.

12. A site according to claim 10, wherein the sealing member is a sewing cuff for attaching the tube to body tissue of the patient.

13. A site according to claim 10, wherein the resealable opening is sealed using a compression seal.

14. A site according to claim 10, wherein the resealable opening is sealed using a mechanical seal.

15. 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.

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

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 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 an analyte in a body of a patient, the system comprising:

a replaceable analyte sensor for determining a level of the analyte in the body of the patient; and

a reusable analyte sensor site including;

a site housing formed to have an interior cavity and comprising;

an outer membrane being made of a material selected to promote vascularization and having a first pore size; and

an inner membrane being made of a material selected to be free of tissue ingress and having a second pore size,

wherein the site housing permits fluid including the analyte to pass through the site housing to the interior cavity to permit measurement by the replaceable analyte sensor; and

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

21. A system according to claim 20, wherein the first pore size of the outer membrane is larger than the second pore size of the inner membrane.

22. A system according to claim 20, wherein the second pore size of the inner membrane is larger than the first pore size of the outer membrane.

23. A system according to claim 20, wherein the outer membrane and the inner membrane are made of the same material.

24. A system according to claim 20, wherein the outer membrane and the inner membrane are made of different materials.

25. A system according to claim 20, wherein the outer membrane is made of a material selected from a group of materials consisting essentially of polytetra fluoroethylene, porous polyurethane, porous silicone, and silicone foam.

26. A system according to claim 20, wherein the inner membrane is made of a material selected from a group of materials consisting essentially of polytetra fluoroethylene, porous polyurethane, porous silicone, and silicone foam.

27. A system according to claim 20, wherein the site housing further comprises at least one intermediate membrane disposed between the outer membrane and the inner membrane and having a third pore size.

28. A system according to claim 27, wherein the third pore size is between the first pore size of the outer membrane and the second pore size of the inner membrane.

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

tube coupled to one end of the site housing; and

a sealing member having a resealable opening, wherein the tube is coupled between the site housing 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.

30. A system according to claim 29, wherein the sealing member is a suture disc for attaching the tube to body tissue of the patient.

31. A system according to claim 29, wherein the sealing member is a sewing cuff for attaching the tube to body tissue of the patient.

32. A system according to claim 29, wherein the resealable opening is sealed using a compression seal.

33. A system according to claim 29, wherein the resealable opening is sealed using a mechanical seal.

34. 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.

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

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 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 infusion site for use with a replaceable catheter for infusing a fluid into a body of a patient, the site comprising:

a site housing formed to have an interior cavity and comprising;

an outer membrane being made of a material selected to promote vascularization and having a first pore size; and

an inner membrane being made of a material selected to be free of tissue ingress and having a second pore size,

wherein the site housing permits the fluid to pass out through the site housing from the interior cavity to deliver the fluid into the body of the patient; and

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

40. A site according to claim 39, wherein the first pore size of the outer membrane is larger than the second pore size of the inner membrane.

41. A site according to claim 39, wherein the second pore size of the inner membrane is larger than the first pore size of the outer membrane.

42. A system for infusing a fluid into a body of a patient, the system comprising:

a replaceable catheter for delivering the fluid into the body of the patient; and

a reusable infusion site comprising;

a site housing formed to have an interior cavity and comprising;

an outer membrane being made of a material selected to promote vascularization and having a first pore size; and

an inner membrane being made of a material selected to be free of tissue ingress and having a second pore size,

wherein the site housing permits the fluid to pass out through the site housing from the interior cavity to deliver the fluid into the body of the patient; and

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

43. A system according to claim 42, wherein the first pore size of the outer membrane is larger than the second pore size of the inner membrane.

44. A system according to claim 42, wherein the second pore size of the inner membrane is larger than the first pore size of the outer membrane.