SENSOR FOR PERCUTANEOUS INTRAVASCULAR DEPLOYMENT WITHOUT AN INDWELLING CANNULA

• US 20090264719A1
• Filed: 04/16/2009
• Published: 10/22/2009
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: GluMetrics, Inc.
• Inventors: Markle, William H., Markle, David R.
• Granted Patent: US 8,512,245 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

The present invention relates to a sensor for percutaneous insertion and intravascular residence without an indwelling cannula. In preferred embodiments, a glucose sensor is inserted into a blood vessel using a removable cannula. After the cannula is removed, the glucose sensor remains within the blood vessel by itself and forms a seal with the patient'"'"'s tissue.

Claims

1. A kit for introducing an analyte sensor into a blood vessel, comprising:

the analyte sensor comprising a distal end region, a proximal end region, and an elongate body, wherein the analyte sensor is sized and configured for percutaneous insertion into the blood vessel, and wherein the analyte sensor comprises an indicator system immobilized along the distal end region, said indicator system being adapted to generate a signal related to the concentration of analyte in the blood, wherein the indicator system is operably coupled to the proximal end region; and

a removable introducer having a distal end region, a proximal end region, and an elongate body comprising a lumen configured to slidably receive the analyte sensor, wherein the elongate body of the introducer has at least one score line along a longitudinal axis, wherein the score line is a weakened portion of the elongate body.

2. The device of claim 1, wherein the elongate body of the introducer comprises a sheath.

3. The device of claim 1, wherein the elongate body of the introducer comprises a tubular structure.

4. The device of claim 1, wherein the elongate body of the introducer comprises at least one of a metal, metal alloy, resin, and polymer.

5. The device of claim 4, wherein the elongate body of the introducer comprises steel, nickel, titanium, aluminum, or a combination.

6. The device of claim 4, wherein the elongate body of the introducer comprises one of polyacrylate, polyurethane, polysulfone, polypropylene, polytetrafluoroethylene, polyethylene, polystyrene, polymethyl methacrylate, polycarbonate, polyethylene terephthalate, and polyvinyl chloride.

7. The device of claim 6, wherein the elongate body of the introducer comprises polyurethane.

8. The device of claim 1, wherein the elongate body of the introducer is flexible.

9. The device of claim 1, wherein the elongate body of the introducer is kink resistant.

10. The device of claim 9, wherein the elongate body of the introducer comprises a metal coil.

11. The device of claim 1, wherein the proximal end of the introducer comprises a hub having a first wing and a second wing located substantially opposite each other.

12. The device of claim 11, wherein the elongate body of the introducer has two score lines located substantially opposite each other, wherein the two score lines divide the elongate body of the introducer into halves, wherein each half comprises one wing.

13. The device of claim 1, wherein the proximal end of the introducer comprises a hub having a first wing and a second wing located at an angle α

to each other.

14. The device of claim 13, wherein the angle α

is less than about 120 degrees.

15. The device of claim 13, wherein the elongate body of the introducer has one score line, wherein the one score line runs along the length of the elongate body and the hub.

16. A method for deploying a sensor in a blood vessel of a patient, comprising:

positioning the sensor in the blood vessel, such that at least a distal portion of the sensor resides within the blood vessel and at least a proximal portion of the sensor extends out of the patient, wherein there are no additional components associated with the sensor within the patient.

17. The method of claim 16, wherein the sensor is non-thrombogenic.

18. The method of claim 17, wherein the sensor is treated with heparin.

19. The method of claim 17, wherein the sensor comprises polytetrafluoroethylene.

20. The method of claim 16, wherein the sensor measures at least one of glucose, potassium ions, oxygen, carbon dioxide, flow rate, pressure, and pH.

21. The method of claim 16, wherein the sensor is an equilibrium sensor.

22. The method of claim 21, wherein the sensor is an optical fiber glucose sensor.

23. The method of claim 22, wherein the optical fiber glucose sensor operates by a fluorophore operably coupled to a glucose binding moiety.

24. The method of claim 16, wherein positioning the sensor further comprises introducing the sensor into the blood vessel through an introducer assembly.

25. The method of claim 24, wherein positioning the sensor further comprises removing the introducer assembly, leaving only the sensor in the patient.

26. A method for measuring an analyte concentration in a blood vessel, comprising:

providing a sensor configured to reside at least in part within the blood vessel and generate a signal related to the analyte concentration in the blood;

introducing the sensor into the blood vessel through an introducer assembly;

removing the introducer assembly, leaving only the analyte sensor in the patient; and

detecting the signal to measure the analyte concentration in the blood.

27. The method of claim 26, wherein removing the introducer assembly comprises at least one of splitting the introducer assembly, peeling the introducer assembly, and cutting the introducer assembly.

28. The method of claim 27, wherein splitting the introducer assembly comprises squeezing a first wing and a second wing together, wherein the first wing and the second wing are disposed opposite each other along a longitudinal axis of the introducer assembly.

29. A method for deploying a sensor in a blood vessel, comprising:

providing an introducer assembly comprising a hypodermic needle slidably engaged within a splitable cannula, wherein a piercing tip of the hypodermic needle extends distally beyond the splitable cannula;

cannulating the blood vessel with the introducer assembly;

withdrawing the hypodermic needle while leaving the splitable cannula in the blood vessel;

inserting the sensor through the splitable cannula and into the blood vessel;

withdrawing the splitable cannula from the blood vessel while leaving the sensor in the blood vessel; and

splitting and removing the cannula from the sensor.

30. The method of claim 29, wherein the blood vessel is a peripheral vein or artery.

31. The method of claim 29, wherein the hypodermic needle comprises a flashback chamber, wherein the flashback chamber fills with blood when the blood vessel is cannulated.

32. The method of claim 31, wherein the hypodermic needle comprises a filter, wherein the filter contains the blood within the flashback chamber when the blood vessel is cannulated.

33. The method of claim 29, wherein the hypodermic needle has a diameter only slightly less than a diameter of the introducer assembly.

34. The method of claim 29, wherein the splitable cannula has a proximal end and a distal end, wherein the distal end of the cannula is beveled.

35. The method of claim 29, wherein withdrawing the splitable cannula from the blood vessel while leaving the sensor in the blood vessel forms a seal around the sensor.

36. A method for continuous monitoring of blood glucose levels in a patient, comprising:

providing an introducer assembly comprising a hypodermic needle slidably engaged within a removable cannula, wherein a piercing tip of the hypodermic needle extends distally beyond the removable cannula;

inserting the introducer assembly into a peripheral vein or artery;

retracting the hypodermic needle from the removable cannula, while leaving the removable cannula in the peripheral vein or artery;

providing an optical glucose sensor comprising a fluorescent indicator system disposed along a distal end region and adapted to generate an optical signal related to the blood glucose level in response to light, an elongate fiber-optic body, and an optical coupling disposed along a proximal end region;

inserting the optical glucose sensor through the removable cannula and into the peripheral vein or artery;

retracting the removable cannula from the vein or artery, while leaving the sensor in the peripheral vein or artery;

removing the removable cannula from the sensor;

connecting the optical coupling to a device comprising a light source and a detector; and

detecting the optical signal to monitor the blood glucose level of the patient.