Sensor introducer system, apparatus and method

• US 20040254433A1
• Filed: 06/12/2003
• Published: 12/16/2004
• Est. Priority Date: 06/12/2003
• Status: Abandoned Application

• Current Assignee: Sorenson Development, Incorporated
• Original Assignee: Sorenson Development, Incorporated
• Inventors: Bandis, Steven D., Hitchcock, Robert W.
• Application Number:
  US10/461,793
• Publication Number:
  US 20040254433A1
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 assembly including an introducer cannula and subcutaneous measurement device, and a method of its use. The device can form an aseptic seal to the introducer to resist passage of pathogens through the cannula. Insertion of the device into the introducer desirably causes a one-way coupling operable to force removal of the introducer and device as a single assembly. Installation of certain devices into certain introducers forms an electrical connection between an electrode carried by the introducer and system electronics. Desirably, the introducer provides a funnel-like structure operable to guide a device'"'"'s probe tip into reception in the introducer'"'"'s cannula.

Claims

1. An introducer, to provide subcutaneous access into a subject for a measurement device, said introducer comprising:

a cannula having a lumen extending between proximal and a distal ends, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and

a substantially planar housing having a bottom surface and a thickness, disposed substantially transverse to said bottom surface, that is less than about one-fourth the size of a maximum width of said bottom surface, said housing being arranged to dispose a first guide structure in association with said proximal end of said lumen, said first guide structure providing a conduit having a first opening arranged to provide a forgiving target, said first opening being disposed at a first end of said conduit and being sized larger than a size of an opening at said proximal end of said lumen, said conduit being reduced in size at a second opening at a second end that is directed distally toward said lumen, and through which first opening to receive in series a removable insertion needle point and a probe tip of a measurement device to facilitate guiding said tip into said proximal end of said cannula.

2. The introducer of claim 1, in combination with a measurement device, wherein:

said measurement device comprises a second guide structure arranged in harmony with said first guide structure and adapted to align an inserted measurement device with said housing for axially directed, snap-fit coupling of said measurement device to structure associated with said housing.

3. The introducer of claim 1, wherein:

said first guide structure comprises a guide surface having improved resistance to needle point sticks compared to material forming said housing.

4. The introducer of claim 1, wherein:

said first guide structure accommodates a misaligned approach angle of said measurement device in excess of 15 degrees.

5. The introducer of claim 1, wherein:

said first guide structure accommodates a misaligned approach angle of said measurement device of up to about 45 degrees.

6. The introducer of claim 1, wherein:

a portion of said first guide structure is arranged to provide a fan shape in a cross-section in a plane passing through an axis of said guide structure.

7. The introducer of claim 1, wherein:

a portion of said first guide structure is arranged to provide a seal surface operable in harmony with structure associated with said device to form an aseptic seal effective to resist passage of contaminant material through said cannula.

8. The introducer of claim 1, in combination with:

an insertion needle assembly adapted to support said cannula for subcutaneous insertion of a distal end portion of said cannula into the subject, and arranged in cooperation with said housing to permit withdrawal of a needle from an installed said cannula to dispose said lumen in open communication with a subcutaneous site in the subject; and

a measurement device comprising a probe tip portion adapted for insertion through said cannula for disposition at said site;

wherein said measurement device carries structure arranged to form a one-way coupling effective to resist withdrawal of said probe tip portion from said cannula.

9. The combination of claim 8, wherein:

said one-way coupling is formed between structure associated with said device and structure associated with said housing.

10. The introducer of claim 1, in combination with:

an insertion needle assembly adapted to support said cannula for subcutaneous insertion of a distal end portion of said cannula into the subject, and arranged in cooperation with said housing to permit withdrawal of a needle from an installed said cannula to dispose said lumen in open communication with a subcutaneous site in the subject; and

a measurement device comprising a probe tip portion adapted for insertion through said cannula for disposition at said site;

wherein structure associated with said housing is arranged to cooperate with structure associated with said device to form an aseptic seal operable to resist passage of contaminants through said lumen.

11. The combination of claim 10, wherein:

said seal is formed by a seal element being placed into compression between structure of said device and structure associated with said housing.

12. The combination of claim 11, wherein:

compression stress in said seal element, operable to form said seal, is effected by insertion of a portion of said device into reception in said housing.

13. The combination of claim 11, wherein:

compression stress in said seal element is maintained by engagement of a one-way coupling between said device and said housing.

14. The introducer of claim 1, in combination with:

a measurement device comprising a probe tip portion adapted for insertion through said cannula for disposition at said site;

wherein;

said cannula carries a first electrode;

said probe tip comprises a second electrode; and

assembly of said device into mating reception in holding structure carried by said housing completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

15. The combination of claim 10, wherein:

said measurement device carries structure arranged to form a one-way coupling effective to resist withdrawal of said probe tip portion from said cannula.

16. The combination of claim 10, wherein:

said cannula carries a first electrode;

said probe tip comprises a second electrode; and

assembly of said device into mating reception in holding structure carried by said housing completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

17. The combination of claim 15, wherein:

said cannula carries a first electrode;

said probe tip comprises a second electrode; and

assembly of said device into mating reception in holding structure carried by said housing completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

18. The combination of claim 8, wherein:

said cannula carries a first electrode;

said probe tip comprises a second electrode; and

assembly of said device into mating reception in holding structure carried by said housing completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

19. An introducer system for a biosensor, said introducer system comprising:

an introducer assembly comprising a cannula having a lumen extending between proximal and distal ends, said proximal end being associated with a housing that carries affixing structure adapted to resist motion of said proximal end relative to a skin surface of a subject, said housing further carrying holding structure configured to interface individually in series with first structure associated with an installation needle and with second structure associated with said biosensor;

an installation needle assembly comprising said first structure and said installation needle, said needle being structured for insertion into said lumen to facilitate installation of a distal end of said cannula into a subcutaneous target site of the subject, said needle being removable from said cannula subsequent to placement of said distal end of said cannula at said subcutaneous target site; and

a biosensor comprising said second structure and a probe portion configured and arranged to permit a distal probe end to slide through said lumen to dispose said probe end at said site when forming an interface between portions of said holding structure and said second structure, said biosensor further being arranged in harmony with said housing to form a barrier operable to resist passage of outer contaminants into said lumen subsequent to forming said connection.

20. The introducer system of claim 19, wherein:

said barrier comprises a seal element placed into compression between structure associated with said housing and structure associated with said biosensor.

21. The introducer system of claim 19, wherein:

said probe portion is held at a proximal end by a hub of said biosensor; and

said barrier comprises structure, carried at a distal end of said hub, that is placed into contact with a sealing surface associated with said housing during attachment of said biosensor to said housing, said barrier being effective to block an annulus disposed between said lumen and a circumference of a shaft of said probe portion.

22. The introducer system of claim 19, wherein:

said probe portion comprises a proximal probe end spaced apart from said distal probe end, said proximal probe end being associated with a hub, a distal end of said hub being arranged to form a sealing surface disposed around a circumference of said proximal probe end; and

said holding structure comprises a seal face structured to cooperate with said sealing surface to maintain a seal, operable to resist passage of contaminants through said lumen, subsequent to connection of said second structure to said holding structure.

23. The introducer system of claim 19, further comprising:

capture structure arranged to form a one-way coupling effective to resist withdrawal of said distal probe end from said cannula subsequent to forming said connection between said holding structure and said second structure.

24. The introducer system of claim 23, wherein said capture structure comprises:

a hook carried by one of said biosensor and said housing; and

a wall associated with a biasing element carried by the other of said biosensor and said housing, said wall and biasing element being arranged operably to engage said hook to form said one-way coupling.

25. The introducer system of claim 19, wherein:

said cannula carries a first electrode component of said biosensor;

said distal probe end comprises a second electrode component of said biosensor; and

assembly of said second structure into mating reception in holding structure carried by said housing completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said biosensor.

26. An introducer system for inserting a probe into a subcutaneous target site in a subject,

said introducer system comprising:

an introducer assembly comprising;

a cannula having a lumen extending axially between a proximal end and a distal end, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and

a housing associated with said proximal end of said cannula and providing holding structure, said introducer assembly being configured to interface separately with;

a needle assembly comprising an extended needle shaft configured for placement through said lumen to dispose a needle point distally to said distal end of said cannula, said needle shaft being structured to facilitate subcutaneous insertion of said distal end of said cannula into the subject, a portion of said needle assembly being structured and arranged in harmony with a portion of said holding structure to effect a releasable coupling therebetween to permit withdrawal of said needle shaft subsequent to placement of said distal end of said cannula in proximity to said site; and

a device comprising a proximal probe end spaced apart from a distal probe end, said distal probe end being structured for sliding installation through said lumen to said subcutaneous target site, said proximal probe end being associated with structure adapted to form a one-way coupling with structure associated with said holding structure effective to resist withdrawal of said distal probe end from said cannula.

27. The introducer system of claim 26, wherein:

said one-way coupling is formed between structure carried by said device and structure carried by said housing.

28. The introducer system of claim 27, wherein:

said device carries a latch element;

said housing carries a wall disposed in association with a bridge element; and

subsequent to assembly of said device into an installed position with respect to said introducer assembly, said latch element is received in contact with said wall.

29. The introducer system of claim 28, wherein:

subsequent to engagement of structure forming said one-way coupling, structure is disposed to support said latch, to resist a deflection of said latch, operable to resist disengagement of said one-way coupling.

30. The introducer system of claim 28, wherein:

said latch element includes a tapered portion; and

during assembly of said device into an installed position with respect to said introducer assembly, said tapered portion causes a displacement of said bridge element operable to permit said latch element to be disposed for reception in said socket.

31. The introducer system of claim 30, wherein:

said bridge is biased to resist displacement, in a direction caused by said tapered portion, operable to capture said latch in engagement in said socket.

32. The introducer system of claim 31, wherein:

said device carries bridge guard structure arranged to resist tool-free displacement of said bridge element subsequent to engagement of said one-way coupling.

33. The introducer system of claim 26, wherein:

said cannula carries a first electrode component of a biosensor;

said distal probe end comprises a second electrode component of said biosensor; and

assembly of said device into mating reception in said holding structure completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

34. An introducer system, for inserting a probe into a subcutaneous target site in a subject, comprising:

an introducer assembly comprising;

a cannula having a lumen extending axially between a proximal end and a distal end, said cannula carrying a first electrode component of a biosensor, said proximal end being associated with affixing structure adapted to resist motion of said proximal end relative to a skin surface of the subject; and

a housing associated with said proximal end of said cannula and providing holding structure, said introducer assembly being configured to interface separately with;

a needle assembly comprising an extended needle shaft configured for placement through said lumen to dispose a needle point distally to said distal end of said cannula, said needle shaft being structured to facilitate subcutaneous insertion of said distal end of said cannula into the subject, a portion of said needle assembly being structured and arranged in harmony with a portion of said holding structure to effect a releasable coupling therebetween to permit withdrawal of said needle shaft subsequent to placement of said distal end of said cannula in proximity to said site; and

a device comprising a proximal probe end spaced apart from a distal probe end, said distal probe end being structured for sliding installation through said lumen to dispose a second electrode component of said biosensor at said subcutaneous target site;

wherein;

assembly of said device into mating reception in said holding structure completes an electrically conductive path between said first electrode and an element of a sensor cable carried by said device.

35. The introducer system of claim 34, wherein said conductive path comprises:

a guide element operable to assist insertion of said probe end into said cannula; and

a switch element biased into contact with a conductor, carried by said device, at an assembled configuration of said device and said holding structure.

36. A method for installing an element of a biosensor into a subcutaneous site in a subject, said method comprising:

providing a cannula having a lumen extending between a proximal end and a distal end, said proximal end being associated with holding structure adapted to interface with an inserter needle assembly, said lumen containing an extended needle shaft of said inserter needle assembly;

using said inserter needle assembly to insert said distal end of said lumen into proximity to the subcutaneous site;

withdrawing said needle shaft from said lumen to provide open communication through said lumen to the subcutaneous site;

affixing structure associated with said proximal end of said cannula to a skin surface of the subject; and

inserting a probe tip of a measurement device into said lumen and bringing said device into seated engagement with said holding structure to form a one-way connection operable to resist tool-free removal of said probe tip from said lumen.

37. The method according to claim 36, wherein:

bringing said device into said seated engagement completes an electrically conductive path between an electrode associated with said cannula and an element of a sensor cable associated with said device.

38. The method according to claim 36, wherein:

bringing said device into said seated engagement also compresses a seal element to form an aseptic seal operable to resist passage of pathogens through said cannula.