Intravascular implantable medical device introduction

• US 9,339,197 B2
• Filed: 05/29/2012
• Issued: 05/17/2016
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Griswold, Erik C., Beasley, Rudolph A., Allan, James Calvin, Anand, Suruchi, Barajas-Torres, Martha A., Poole, Matthew S., Srinivas, Arvind K., Waldhauser, Steven L., Berthiaume, William
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US13/482,816
• Publication Number:
  US 20130253344A1
• Time in Patent Office: 1,449 Days
• Field of Search: 600/486, 600/300, 604/95.01, 604/96.01, 606/129
• US Class Current: 1/1
• 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: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

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 an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an inflatable member at its distal portion. The inflatable member is inflatable from a proximal end of the inner sheath to close-off the distal opening of the outer sheath when inflated. The inner sheath further includes a stopper proximally located relative to the inflatable member. The inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper. The inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion 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 an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient; and

an elongated inner sheath with an inflatable member at a distal portion of the inner sheath, wherein the inflatable member is selectively inflatable from a proximal end of the inner sheath, wherein the inflatable member is configured to substantially close-off the distal opening of the outer sheath when inflated, wherein the inner sheath is slidable within the inner lumen of the outer sheath,

wherein the inner sheath further includes a stopper proximally located relative to the inflatable member, wherein the inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper,

wherein the kit is configured such that the inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath.

2. The kit of claim 1, wherein the stopper is remotely controllable from a proximal end of the inner sheath to push the implantable medical device from the distal portion of the outer sheath when the inflatable member has been retracted towards the stopper to a position proximal to the implantable medical device within the inner lumen of the outer sheath.

3. The kit of claim 1, wherein the inner sheath further includes a tether that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from the distal portion of the outer sheath.

4. The kit of claim 3, wherein the tether includes a helical element, wherein remotely controlling the tether to release the implantable medical device from the distal portion of the outer sheath includes rotating the helical element such that the helical element releases a looped element of the implantable medical device.

5. The kit of claim 4, wherein remotely controlling the tether to release the implantable medical device from the distal portion of the outer sheath further includes pushing the implantable medical device out of the distal portion of the outer sheath with the helical element.

6. The kit of claim 1, further comprising a guidewire,

wherein the inner sheath includes a guidewire lumen extending throughout the length of the inner sheath,

wherein the outer sheath and the inner sheath are configured to follow a guidewire as an assembly with the guidewire lumen of the inner sheath sliding along the guidewire,

wherein, in the assembly, the inner sheath is within the lumen of the outer sheath and the inflatable member of the inner sheath extends beyond the distal opening of the outer sheath and is inflated to substantially fill the inner lumen and close-off the distal opening of the outer sheath.

7. The kit of claim 6, wherein the inner sheath further includes a tapered flexible tip distally located relative to the inflatable member, wherein the guidewire lumen extends through the tapered flexible tip.

8. The kit of claim 1, wherein the inner sheath further includes a tapered flexible tip distally located relative to the inflatable member.

9. The kit of claim 1, further comprising the medical device.

10. The kit of claim 9, wherein the medical device is a leadless pacemaker.

11. The kit of claim 9, 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.

12. The kit of claim 9, wherein the implantable medical device includes an expandable fixation element deployable from a collapsed position to an expanded position, the expanded position 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.

13. The kit of claim 12, wherein the implantable medical device is configured for implantation within a pulmonary artery of the patient.

14. The kit of claim 9, wherein the implantable medical device includes an active fixation element configured to secure the implantable medical device component to a patient tissue.

15. The kit of claim 14, 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.

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

inflating an inflatable member of a kit for intravascular implantation of the implantable medical device within the patient, the kit comprising;

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

an elongated inner sheath with the inflatable member at a distal portion of the inner sheath, wherein the inflatable member is selectively inflatable from a proximal end of the inner sheath, wherein the inflatable member is configured to substantially close-off the distal opening of the outer sheath when inflated, wherein the inner sheath is slidable within the inner lumen of the outer sheath, wherein the inner sheath further includes a stopper proximally located relative to the inflatable member;

wherein the inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper, wherein the kit is configured such that the inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath

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

deflating the inflatable member; and

retracting the inflatable member in the proximal direction towards the stopper and past the implantable medical device that is positioned within the distal portion of the outer sheath.

17. The method of claim 16,

wherein the inner sheath includes a guidewire lumen extending throughout the length of the inner sheath, the guidewire lumen being configured to slidably receive the guidewire, the method further comprising:

positioning a distal end of a guidewire via the vasculature of the patient proximate to the target site within the patient;

sliding the assembly including the outer sheath and the inner sheath over the guidewire to position the distal end of the assembly proximate to the target site within the patient.

18. The method of claim 17, wherein the inner sheath further includes a tapered flexible tip distally located relative to the inflatable member, wherein the guidewire lumen extends through the tapered flexible tip.

19. The method of claim 16, further comprising remotely controlling the stopper from a proximal end of the inner sheath to push the implantable medical device from the distal portion of the outer sheath after the inflatable member has been refracted towards the stopper to a position proximal to the implantable medical device within the inner lumen of the outer sheath.

20. The method of claim 16, wherein the inner sheath further comprises a tether that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from the distal portion of the outer sheath, the method further comprising remotely controlling the tether to deploy the implantable medical device from the distal portion of the outer sheath.

21. The method of claim 16, wherein the target site is within a pulmonary artery of the patient.

22. The method of claim 21, wherein the implantable medical device includes a pressure sensor.

23. The method of claim 16, wherein the target site is within a right ventricle of the patient.

24. The method of claim 23, 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.