Systems and methods for transcutaneously implanting medical devices

• US 9,743,862 B2
• Filed: 03/29/2012
• Issued: 08/29/2017
• Est. Priority Date: 03/31/2011
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley, Rush, Benjamin Mark
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/434,804
• Publication Number:
  US 20120253145A1
• Time in Patent Office: 1,979 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

Systems and methods for transcutaneously implanting medical devices, such as in vivo analyte sensors, are provided. The systems and methods involve the use of introducers or inserters made of shape memory alloy (SMA) materials which are transitionable from one operative state or configuration to another operative state or configuration, wherein the transition from state to state enables the transcutaneous implantation and/or transcutaneous explantation of the medical device.

Claims

1. A system for transcutaneously implanting a medical device, the system comprising:

an introducer having at least a portion engageable with at least a portion of a medical device, wherein the introducer comprises a shape memory alloy having a predetermined activation temperature range,

wherein the introducer, at a temperature below the predetermined activation temperature range, is in a first shape memory state configuration in which the introducer includes a first transition bend adjacent to a straight proximal portion of the introducer, and

wherein the introducer, at a temperature above the predetermined activation temperature range, is in a second shape memory state configuration in which the introducer includes a second transition bend adjacent to a straight distal portion of the introducer; and

an activating component to change the temperature of the introducer to transition the introducer from the first shape memory state configuration to the second shape memory state configuration, wherein said transition changes the shape of the introducer and translates the medical device engaged with the introducer from a position above the skin surface to a position at least partially through the skin surface;

wherein said transition is driven by a martensitic-to-austenitic change of the shape memory alloy.

2. The system of claim 1 wherein the activating component comprises an electrical current generating component electrically coupled to the introducer to heat the introducer above the predetermined activation temperature range to cause the transition of the introducer from the first shape memory state configuration to the second shape memory state configuration.

3. The system of claim 1 further comprising a housing configured for releasable placement on a skin surface of a host using an adhesive, wherein the introducer is configured to be at least partially positioned within the housing when in the first shape memory state configuration.

4. The system of claim 3 wherein the housing comprises a compartment within which the introducer is configured to be at least partially contained when in the first shape memory state configuration.

5. The system of claim 1 wherein the shape memory alloy comprises one or more of nickel-titanium, copper-zinc-aluminum-nickel, copper-aluminum-nickel, and alloys of zinc, copper, gold and iron.

6. The system of claim 1 wherein the medical device is an analyte sensor and further wherein the portion of the introducer engageable with the medical device defines a major axis wherein, during the transition from the first shape memory state configuration to the second shape memory state configuration, a distal portion of the introducer changes shape along the major axis, while a proximal portion of the introducer remains fixed relative to the activating component.

7. The system of claim 1 wherein the introducer comprises at least one coupling member for securing the medical device to the introducer at least when in the first shape memory state configuration.

8. The system of claim 1 wherein the introducer, in the first shape memory state configuration, comprises a U-shaped distal portion that transitions at a bend to a straight proximal portion, and wherein the introducer, in the second shape memory state configuration, is L-shaped.

9. The system of claim 1, wherein the introducer includes an insulative layer to protect the user or medical device from heat or electrical damage.

10. The system of claim 1, wherein the location of the first transition bend along the length of the introducer differs from the location of the second transition bend.

11. The system of claim 1, wherein the location of the first transition bend along the length of the introducer coincides with the location of the second transition bend.

12. A method for transcutaneously implanting a medical device, at least a portion of which is flexible, the method comprising:

engaging at least the flexible portion of the medical device with an introducer, wherein the engaged introducer and medical device are in a nested arrangement, and wherein the introducer comprises a shape memory alloy having a predetermined activation temperature range,

wherein the introducer, at a temperature below the predetermined activation temperature range is in a first shape memory state configuration in which the introducer includes a first transition bend adjacent to a straight proximal portion of the introducer, and

wherein the introducer, at a temperature above the predetermined activation temperature range is in a second shape memory state configuration in which the introducer includes a second transition bend adjacent to a straight distal portion of the introducer; and

positioning a skin-penetrating end of the introducer adjacent the skin surface; and

changing the temperature of the introducer to transition the introducer from the first shape memory state configuration to the second shape memory state configuration such that the introducer penetrates through the skin surface and transcutaneously implants the flexible portion of the medical device, and further wherein said transition changes the shape of the introducer, and is driven by a martensitic-to-austenitic change of the shape memory alloy.

13. The method of claim 12 wherein engaging the flexible portion of the medical device with the introducer in a nested arrangement comprises cooling the introducer below the predetermined activation temperature range while the medical device is structurally aligned along a major axis of the introducer, and wherein a distal portion of the introducer changes shape along the major axis, while a proximal portion of the introducer remains fixed relative to the activating component.

14. The method of claim 13 wherein transitioning the introducer from the first shape memory state configuration to the second shape memory state configuration comprises applying a selected amount of electrical current from an electrical current generating component electrically coupled to the introducer to heat the introducer above the predetermined activation temperature range.

15. The method of claim 12 further comprising removing the introducer from the skin while leaving the medical device transcutaneously implanted.

16. The method of claim 12 further comprising maintaining the introducer within the skin along with the transcutaneously implanted medical device for the useful life of the medical device.

17. The method of claim 16 further comprising simultaneously removing the introducer and the medical device from the skin subsequent to the expiration of the useful life of the medical device.

18. The method of claim 17 wherein the simultaneous removal of the introducer and the medical device from the skin comprises transitioning the introducer from the second shape memory state configuration to the first shape memory state configuration.

19. The method of claim 12 wherein the introducer, in the first shape memory state configuration, comprises a U-shaped distal portion that transitions at a bend to a straight proximal portion, and wherein the introducer, in the second shape memory state configuration, is L-shaped.

20. The method of claim 12, wherein the introducer includes an insulative layer to protect the user or medical device from heat or electrical damage.