IMPLANTABLE MEDICAL DEVICE DELIVERY WITH INNER AND OUTER SHEATHS

• US 20130253343A1
• Filed: 05/29/2012
• Published: 09/26/2013
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Waldhauser, Steven L., Wien, Kelly M., Yasger, Kendra
• Granted Patent: US 9,833,625 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath forming a second inner lumen. An outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen. The second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device. The inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.

Claims

1. A kit for intravascular implantation of an implantable medical device within a patient, the kit comprising:

an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient; and

an elongated inner sheath forming a second inner lumen, wherein an outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen,

wherein the second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device,

wherein the inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.

2. The kit of claim 1, wherein the distal end of the inner sheath is elastically deformed within the first inner lumen such that the distal end of the inner sheath is configured to uncurl and expose the implantable medical device when the distal end of the inner sheath passes out of the distal opening of the outer sheath.

3. The kit of claim 1, further comprising the medical device, wherein the implantable medical device includes an expandable fixation element expandable from a collapsed position to an expanded position, wherein at least a portion of the expandable fixation element assumes the expanded position when the distal end of the inner sheath passes out of the distal opening of the outer sheath.

4. The kit of claim 3, wherein the implantable medical device is deployable from the inner sheath by retracting the inner sheath into the outer sheath after the portion of the expandable fixation element assumes the expanded position such that the distal end of the outer sheath interacts with the expandable fixation element to slide the implantable medical device out of the second inner lumen.

5. The kit of claim 3,

wherein the implantable medical device is partially deployable from the inner sheath by exposing a portion of the inner sheath and a portion of the implantable medical device out of the distal end of the outer sheath,

wherein the implantable medical device is retractable after being partially deployed by retracting the inner sheath into the outer sheath to return the implantable medical device to the first inner lumen.

6. The kit of claim 5, wherein partially deploying the implantable medical device causes the portion of the expandable fixation element to assume the expanded position, and

wherein retracting the implantable medical device by retracting the inner sheath into the outer sheath causes the portion of the expandable fixation element to resume the collapsed position within the second inner lumen.

7. The kit of claim 3, wherein the medical device is a leadless pacemaker.

8. The kit of claim 3, wherein the medical device includes at least one sensor selected from a group consisting of:

a pressure sensor;

an electrocardiogram sensor;

a fluid flow sensor;

an oxygen sensor;

an accelerometer;

a glucose sensor;

a potassium sensor; and

a thermometer.

9. The kit of claim 3, wherein the expanded position is configured to secure the implantable medical device within a vasculature of a patient,

wherein the medical device includes:

a housing;

at least one sensor on or within the housing; and

control circuitry within the housing configured to monitor one or more physiological parameters of the patient via the at least one sensor.

10. The kit of claim 9, wherein the implantable medical device is configured for implantation within a pulmonary artery of the patient.

11. The kit of claim 3, wherein the expandable fixation element includes an active fixation element configured to secure the implantable medical device component to a patient tissue.

12. The kit of claim 11, wherein the active fixation element includes a set of active fixation tines that are deployable from a spring-loaded position in which distal ends of the active fixation tines point away from an implantable medical device housing to a hooked position in which the active fixation tines bend back towards the implantable medical device housing.

13. A method for intravascular implantation of an implantable medical device within a patient comprising:

positioning a distal end of an assembly including an elongated outer sheath and an elongated inner sheath via a vasculature of the patient proximate to a target site within the patient, wherein the outer sheath forms an inner lumen with a distal opening,

wherein the inner sheath forms a second inner lumen, wherein an outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen,

wherein assembly further includes an implantable medical device carried within the second inner lumen at a distal end of the inner sheath,

wherein the inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath; and

sliding the distal end of the inner sheath out of the first inner lumen to expose a portion of the inner sheath and a portion of the implantable medical device out of the distal end of the outer sheath.

14. The method of claim 13, wherein the distal end of the inner sheath is elastically deformed within the first inner lumen such that the distal end of the inner sheath uncurls to expose the implantable medical device when the distal end of the inner sheath passes out of the distal opening of the outer sheath.

15. The method of claim 13, wherein the implantable medical device includes an expandable fixation element expandable from a collapsed position to an expanded position, wherein at least a portion of the expandable fixation element assumes the expanded position when the distal end of the inner sheath passes out of the distal opening of the outer sheath.

16. The method of claim 15, further comprising deploying the implantable medical device from the inner sheath by retracting the inner sheath into the outer sheath after the portion of the expandable fixation element assumes the expanded position such that the distal end of the outer sheath interacts with the expandable fixation element to slide the implantable medical device out of the second inner lumen.

17. The method of claim 13,

wherein sliding the distal end of the inner sheath out of the first inner lumen to expose a portion of the inner sheath and a portion of the implantable medical device out of the distal end of the outer sheath first partially deploys the implantable medical device,

the method further comprising retracting the inner sheath into the outer sheath to return the implantable medical device to the first inner lumen.

18. The method of claim 17,

wherein the implantable medical device includes an expandable fixation element expandable from a collapsed position to an expanded position, wherein at least a portion of the expandable fixation element assumes the expanded position when the distal end of the inner sheath passes out of the distal opening of the outer sheath,

wherein partially deploying the implantable medical device causes a portion of the expandable fixation element to assume the expanded position, and

wherein retracting the implantable medical device by retracting the inner sheath into the outer sheath causes the portion of the expandable fixation element to resume the collapsed position within the second inner lumen.

19. The method of claim 13, wherein the target site is within a pulmonary artery of the patient.

20. The method of claim 19, wherein the implantable medical device includes a pressure sensor.

21. The method of claim 13, wherein the target site is within a right ventricle of the patient.

22. The method of claim 21, wherein the implantable medical device is a leadless pacemaker, wherein the medical device includes:

a housing;

at least one stimulation electrode on an exterior surface of the housing; and

control circuitry within the housing configured to deliver cardiac stimulation therapy to the patient via the at least stimulation electrode.