System, apparatus and method for inferring glucose levels within the peritoneum with implantable sensors

• US 7,228,160 B2
• Filed: 11/06/2003
• Issued: 06/05/2007
• Est. Priority Date: 11/13/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Sorenson Media, Inc. (Nielsen Holdings plc)
• Inventors: Sorenson, James L., Gordon, Kevin W., Haight, LeVoy Golden
• Primary Examiner(s): Winakur; Eric
• Assistant Examiner(s): Berhanu; Etsub
• Application Number:
  US10/703,152
• Publication Number:
  US 20040152187A1
• Time in Patent Office: 1,307 Days
• Field of Search: 600/316, 600/317, 600/323, 600/325, 600/341, 600/342, 600/343
• US Class Current: 600/316
• CPC Class Codes: C12Q 1/54 involving glucose or galactose

Abstract

A glucose sensor assembly useful in patient systems includes an oxygen sensor from which glucose levels in the vicinity of the peritoneal cavity may be inferred. The sensor assembly may be associated with electronics, such as any or all of a DC power supply, an LED source of blue light, a photoreceptor for red light, a CPU, and transceiver, by a direct percutaneous connection. Alternatively they may be associated transdermally with the sensor and some of the electronics being located subdurally. Insulin infusion means are contemplated to respond manually or mechanically to information from the sensors through the CPU. Mechanical response may be automatic. Infusion means may be located subdurally. It is contemplated that the present invention enable revitalization or replacement of fluorescing compounds and glucose oxidase within the sensor assembly.

Claims

1. A method of measuring glucose concentration, comprising:

providing a first sensor wherein luminescent material encapsulated by a first oxygen permeable polymer barrier is located proximal a distal end of a first optical fiber;

providing a second sensor wherein luminescent material and glucose oxidase adjacent each other and together encapsulated by a second oxygen permeable polymer barrier are located proximal a distal end of a second optical fiber in near proximity to said first sensor for placement of said first and second sensors in the vicinity of a peritoneal cavity of a medical patient;

providing a catheter, comprising at least one auxiliary catheter lumen in communication with each said luminescent material, whereby said luminescent material upon becoming degraded through repeated fluorescing may be replaced with upgraded or new luminescent material;

providing a source of blue light, emissions of which transmitted through said distal ends of said first and second optical fibers are capable of fluorescing within said luminescent material of both said first and second sensors and of being reemitted in a form of red light from both said first and second sensors;

providing a photoreceptor structured and arranged to receive said reemitted red light from both said first and second sensors, said photoreceptor being in communication with a processor capable of comparing information transmitted through said photoreceptor from said first and second sensors;

providing a cannula, comprising an axial lumen and a leading end susceptible to insertion through an abdominal wall of said patient;

inserting said leading end into said vicinity of said peritoneal cavity of said patient;

introducing both said first and second sensors through said axial lumen and into said vicinity of said peritoneal cavity;

measuring glucose concentration with said first and second sensors; and

displaying said measured glucose concentration.

2. The method according to claim 1, further comprising providing a direct current power supply which is located external said medical patient and which is structured and arranged to be capable of exciting said source of blue light.

3. The method according to claim 2, wherein said photoreceptor is located-external said patient.

4. The method according to claim 2, wherein said source of blue light and said photoreceptor are located external said patient.

5. The method according to claim 1, wherein said cannula upon insertion is structured and arranged to be capable of separating tissues comprising said abdominal wall with minimal severance of said tissues.

6. The method according to claim 1, wherein said first and second sensors are replaced periodically.

7. The method of claim 1, further comprising provision of a catheter assembly whereby therapeutic fluids may be infused into the vicinity of said peritoneal cavity.

8. The method of claim 7, wherein said catheter assembly comprises an in-line filter.

9. The method of claim 8, wherein said catheter assembly may be structured and arranged for disconnection of a proximal portion of said catheter assembly at a location proximal said filter in preparation for attachment of successive replacement catheter proximal portions.

10. The method according to claim 9, wherein said filter is structured and arranged to filter both air and impurities, including particulate matter and microorganisms harmful to said peritoneal cavity.

11. The method according to claim 9, whereby said therapeutic fluids are infused in response to direction from said processor based upon said information.

12. The method according to claim 11, wherein said therapeutic fluids are infused mechanically.

13. The method according to claim 12, wherein said mechanical infusion is automatic.

14. The method according to claim 12, wherein said mechanical infusion is remotely actuated.

15. The method according to claim 11, wherein said therapeutic fluids are infused manually.

16. A method of measuring glucose concentration, comprising:

providing a first sensor wherein luminescent material encapsulated by a first oxygen permeable polymer barrier is located proximal a distal end of a first optical fiber;

providing a second sensor wherein luminescent material and glucose oxidase adjacent each other and together encapsulated by a second oxygen permeable polymer barrier are located proximal a distal end of a second optical fiber in near proximity to said first sensor for placement of said first and second sensors in vicinity of a peritoneal cavity of a medical patient;

providing a source of blue light, emissions of which transmitted through said distal ends of said first and second optical fibers are capable of fluorescing within said luminescent material of both said first and second sensors and of being reemitted in a form of red light from both said first and second sensors;

providing a photoreceptor structured and arranged to receive said reemitted red light from both said first and second sensors, said photoreceptor being in communication with a processor capable of comparing information transmitted through said photoreceptor from said first and second sensors;

providing a catheter, comprising an auxiliary lumen structured and arranged to be capable of being placed in communication with said glucose oxidase, said glucose oxidase configured for replacement with upgraded or new glucose oxidase upon becoming degraded from exposure to oxygen and glucose in said vicinity of said peritoneal cavity;

providing a cannula, comprising an axial lumen and a leading end susceptible to insertion through an abdominal wall of said patient;

inserting said leading end into said vicinity of said peritoneal cavity of said patient;

introducing both said first and second sensors through said axial lumen and into said vicinity of said peritoneal cavity;

measuring glucose concentration with said first and second sensors; and

displaying said measured glucose concentration.

17. The method according to claim 16, wherein said source of blue light is structured and arranged to be implanted within a body of said patient.

18. The method according to claim 17, wherein a direct current power supply is provided to excite said source of blue light through a layer of skin of said patient.

19. The method according to claim 17, wherein a direct current power supply is provided to excite said source of blue light and is structured and arranged to be implanted within said body of said patient.

20. The method according to claim 16, wherein said photoreceptor is structured and arranged to be implanted internal said patient.

21. The method according to claim 20, wherein a processor is provided to receive information signals from said photoreceptor through a layer of skin of said patient.

22. The method according to claim 21, wherein said processor is placed in communication with a means of infusing insulin in accordance with a prescribed and preprogrammed insulin dosage, regimen, and protocol algorithm and responsive to information from said processor.

23. The method according to claim 22, wherein said means of infusing insulin is structured and arranged to comprise a reservoir implantable within said patient.

24. The method according to claim 23, wherein said reservoir is structured and arranged to be refillable.

25. The method according to claim 20, wherein a processor is provided to receive information signals from said photoreceptor and is structured and arranged to be implanted internal said patient and to be in communication with a monitor for access to information from said processor.

26. A system for measuring glucose concentration, comprising:

a first sensor wherein luminescent material encapsulated by a first oxygen permeable polymer barrier is located proximal a distal end of a first optical fiber;

a second sensor wherein luminescent material and glucose oxidase adjacent each other and together encapsulated by a second oxygen permeable polymer barrier are located proximal a distal end of a second optical fiber in near proximity to said first sensor for placement of said first and second sensors in the vicinity of a peritoneal cavity of a medical patient, said first and second sensors configured to measure glucose concentration and operably coupled to a display configured for displaying said measured glucose concentration;

a catheter, comprising an auxiliary lumen structured and arranged to be capable of being placed in communication with said glucose oxidase, said glucose oxidase configured for replacement with upgraded or new glucose oxidase upon becoming degraded from exposure to oxygen and glucose in said vicinity of said peritoneal cavity;

a source of blue light, emissions of which transmitted through said distal ends of said first and second optical fibers are capable of fluorescing within said luminescent material of both said first and second sensors and of being reemitted in a form of red light from both said first and second sensors;

a photoreceptor structured and arranged to receive said reemitted red light from both said first and second sensors, said photoreceptor being in communication with a processor capable of comparing information transmitted through said photoreceptor from said first and second sensors; and

a cannula, comprising an axial lumen and a leading end susceptible to insertion through an abdominal wall of said patient.

27. The system according to claim 26, wherein said blue light comprises electromagnetic wavelengths less than 500 nanometers.

28. The system according to claim 26, wherein said red light comprises electromagnetic wavelengths in excess of 600 nanometers.

29. The system according to claim 26, wherein said first and second optical fibers each have a diameter between about 50 micrometers and about 600 micrometers.

30. The system according to claim 26 wherein said luminescent material comprises ruthenium (II) complex or an aromatic hydrocarbon.

31. The system according to claim 30, wherein said aromatic hydrocarbon includes carbazole, acridone, fluoranthene, 9,10-diphenylanthracene, phrysene, benz(a)anthracene, tetracene, pyrene, dibenz(ah)anthracene, perylene, benzo(ghi)perylene, coronene, anthanthrene, decacyclene, 1-aminoanthracene, 2-aminoanthracene or 1-aminopyrene.

32. A system for measuring glucose concentration, comprising:

a first sensor wherein luminescent material encapsulated by a first oxygen permeable polymer barrier is located proximal a distal end of a first optical fiber;

a second sensor wherein luminescent material and glucose oxidase adjacent each other and together encapsulated by a second oxygen permeable polymer barrier are located proximal a distal end of a second optical fiber in near proximity to said first sensor for placement of said first and second sensors in the vicinity of a peritoneal cavity of a medical patient, said first and second sensors configured to measure glucose concentration and operably coupled to a display configured for displaying said measured glucose concentration;

a catheter, comprising at least one auxiliary catheter lumen in communication with said luminescent material, said luminescent material configured for replacement with upgraded or new luminescent material upon becoming degraded through repeated fluorescing;

a source of blue light, emissions of which transmitted through said distal ends of said first and second optical fibers are capable of fluorescing within said luminescent material of both said first and second sensors and of being reemitted in a form of red light from both said first and second sensors;

a photoreceptor structured and arranged to receive said reemitted red light from both said first and second sensors, said photoreceptor being in communication with a processor capable of comparing information transmitted through said photoreceptor from said first and second sensors; and

a cannula, comprising an axial lumen and a leading end susceptible to insertion through an abdominal wall of said patient.

33. The system according to claim 32, further comprising a direct current power supply which is configured to be located outside a body of said patient and which is structured and arranged to excite said source of blue light.

34. The system according to claim 33, wherein said photoreceptor is located outside of said body.

35. The system according to claim 34, wherein said source of blue light and said photoreceptor is located outside of said body.

36. The system according to claim 32, wherein said cannula is configured to separate with minimal severance of bodily tissues surrounding said peritoneal cavity upon insertion of said cannula through said tissues, whereby a passage is opened for placement of said first and second sensors within said peritoneal cavity.