Apparatus and method for implantation of sensors

• US 5,299,571 A
• Filed: 01/22/1993
• Issued: 04/05/1994
• Est. Priority Date: 01/22/1993
• Status: Expired due to Term

• Current Assignee: Disetronic Licensing Ag (Roche Holding AG)
• Original Assignee: Eli Lilly and Company
• Inventors: Mastrototaro, John J.
• Primary Examiner(s): PRICE, RICHARD THOMAS JR
• Application Number:
  US08/008,611
• Time in Patent Office: 438 Days
• Field of Search: 604/52, 604/49, 604/51, 128/180, 128/632, 128/637, 128/634, 128/635
• US Class Current: 600/347
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

An apparatus for implantation of in vivo sensors includes a housing, a dual-lumen tube extending therefrom, and an in vivo sensor received within one of the lumen of the tube. A needle is received within the other lumens of the tube, and is used to insert the tube through the skin. After implantation, the needle is removed, and the flexible tube and sensor remaining beneath the skin provides the user with reduced irritation and greater comfort. The associated method for subcutaneous implantation of a sensor for use in vivo is also disclosed.

Claims

1. An apparatus for implantation of a sensor beneath the skin surface which comprises:

a housing;

a dual-lumen tube having a proximal end attached to said housing and having a distal end projecting from said housing, said tube, including the distal end, defining a first lumen and a second lumen;

a needle received within the first lumen of said tube, said needle including a proximal end and a pointed distal end extending outwardly of the distal end of said tube; and

a sensor received within the second lumen of said tube, said sensor including a sensing element positioned within the second lumen adjacent the distal end of said tube and outside of said housing, said sensor further including means for communicating information sensed by the sensing element to a location spaced from the sensing element,

whereby implantation of said sensor is accomplished by forcing said needle and said tube into a desired location beneath the skin surface,

2. The apparatus of claim 1 in which said sensor is a glucose sensor.

3. The apparatus of claim 1 in which the means for communication includes a wire lead extending from the sensing element through the second lumen to the proximal end of said tube.

4. The apparatus of claim 3 in which said housing includes means for receiving information from the sensing element and displaying information concerning the sensed condition.

5. The apparatus of claim 1 in which said tube includes an opening at the distal end exposing a portion of the second lumen, the sensing element being positioned within the opening to be exposed exteriorly of said tube.

6. The apparatus of claim 5 in which the means for communicating includes a wire lead extending from the sensing element through the second lumen to the proximal end of said tube.

7. The apparatus of claim 1 in which said needle is removeably received by the first lumen, said needle including means for removal of said needle from the first lumen.

8. The apparatus of claim 7 in which the means for removal includes a handle attached to the proximal end of said needle.

9. The apparatus of claim 8 in which said housing defines a cavity and in which the handle of said needle is received within the cavity.

10. The apparatus of claim 9 in which said housing further includes a cover having a first position closing the cavity and a second position opening the cavity, the handle of said needle being receivable within the cavity with the cover in the closed position, said needle being removeable from said tube and housing with the cover in the open position.

11. The apparatus of claim 1 in which said tube includes a distal end having an exterior surface which is tapered inwardly in the distal direction.

12. The apparatus of claim 1 in which the second lumen is crescent-shaped.

13. The apparatus of claim 1 and which further includes means for securing said housing to a support surface.

14. The apparatus of claim 13 in which said housing includes a bottom surface from which said tube projects, said means for securing including adhesive material located on the bottom surface of said housing.

15. A method for implantation of a sensor beneath the skin surface which comprises the steps of:

a. providing an implanting device which includes a housing, a dual-lumen tube having a proximal end attached to the housing and having a distal end projecting from the housing, the tube, including the distal end, defining a first lumen and a second lumen, a needle received within the first lumen of the tube, the needle including a proximal end and a pointed proximal end extending outwardly of the distal end of the tube, and a sensor received within the second lumen of the tube, the sensor including a sensing element positioned within the second lumen adjacent the distal end of the tube and outside of the housing, the sensor further including means for communicating information sensed by the sensing element to a location spaced from the sensing element; and

,

b. pressing the needle through the skin surface to position the distal end of the tue to a desired location beneath the skin surface.

16. The method of claim 15 and which further includes, after step b, the step of removing the needle from the tube.

17. The method of claim 16 in which the needle includes a handle, the removing of the needle comprising pulling on the handle to remove the needle from the tube.

18. The method of claim 15 and which further includes, after step b, the step of securing the housing to the skin surface.

19. The method of claim 18 in which the housing includes a bottom surface from which the tube projects, the bottom surface including an adhesive coating, the step of securing the housing comprising adhering the bottom surface of the housing to the skin surface.

20. The method of claim 18 and which further includes, after step b, the step of removing the needle from the tube.

21. The method of claim 15 in which step b. comprises positioning the distal end of the tube in a location within the subcutaneous tissue.