Systems and methods for transcutaneously implanting medical devices
First Claim
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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, andwherein 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.
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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.
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Citations
20 Claims
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1. A system for transcutaneously implanting a medical device, the system comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method for transcutaneously implanting a medical device, at least a portion of which is flexible, the method comprising:
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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. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20)
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Specification