Systems and Methods for Transcutaneously Implanting Medical Devices

• US 20120253145A1
• Filed: 03/29/2012
• Published: 10/04/2012
• 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
• Granted Patent: US 9,743,862 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 is at least partially formed from a shape memory material; and

an activating component to activate the introducer to transition from a first operative shape memory state to a second operative shape memory state, wherein said transition translates the medical device engaged with the introducer from a position above the skin surface to at least partially through the skin surface.

2. The system of claim 1 wherein the first operative shape memory state comprises a heat-unstable shape and the second operative shape memory state comprises a heat-stable shape.

3. The system of claim 2 wherein the activating component comprises an electrical current generating component electrically coupled to the introducer.

4. The system of claim 1 wherein the first operative shape memory state comprises a loaded configuration and the second operative shape memory state comprises an unloaded configuration.

5. The system of claim 4 wherein the activating component comprises a driving mechanism mechanically coupled to the introducer.

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

7. The system of claim 6 wherein the housing comprises a compartment within which the introducer is configured to be at least partially contained when in the first operative shape memory state.

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

9. The system of claim 1 wherein the portion of the introducer engageable with the medical device defines a major axis wherein, during the transition from the first operative shape memory state to the second operative shape memory state, the introducer changes shapes along the major axis.

10. 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 operative memory state.

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

providing an introducer, wherein the introducer is at least partially formed from a shape memory material;

engaging at least the flexible portion of the medical device with the introducer, wherein the engaged introducer and medical device are in a nested arrangement, and wherein the introducer is in a first operative shape memory state;

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

transitioning the introducer from the first operative shape memory state to a second operative shape memory state, wherein the introducer penetrates through the skin surface and transcutaneously implants the flexible portion of the medical device.

12. The method of claim 11 wherein engaging the flexible portion of the medical device with the introducer in a nested arrangement comprises cooling the introducer to a predefined temperature while the medical device is structurally aligned along a major axis of the introducer.

13. The method of claim 12 wherein transitioning the introducer from the first operative shape memory state to the second operative shape memory state comprises applying a selected amount of electrical current to the introducer.

14. The method of claim 11 wherein engaging the flexible portion of the medical device with the introducer in a nested arrangement comprises loading the introducer to a reduced profile while the medical device is structurally aligned along a major axis of the introducer and positioning the introducer and nested sensor in a confined space.

15. The method of claim 14 wherein transitioning the introducer from the first operative shape memory state to the second operative shape memory state comprises releasing the introducer from the confined space.

16. The method of claim 14 wherein the confined space is provided within a housing that is configured for placement on the skin surface.

17. The method of claim 11 further comprising removing the introducer from the skin while leaving the medical device transcutaneously implanted.

18. The method of claim 17 wherein the removing the introducer from the skin while leaving the medical device transcutaneously implanted comprises manually retracting the introducer from within the skin.

19. The method of claim 11 further comprising maintaining the introducer within the skin along with the transcutaneously implanted medical device for the useful life of the medical device.

20. The method of claim 19 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.

21. The method of claim 20 wherein the simultaneous removal of the introducer and the medical device from the skin comprises manually retracting the introducer and the medical device.

22. The method of claim 20 wherein the simultaneous removal of the introducer and the medical device from the skin comprises transitioning the introducer from the second operative shape memory state to the first operative shape memory state.