Pass-through implantable medical device delivery catheter with removeable distal tip

• US 10,485,435 B2
• Filed: 05/29/2012
• Issued: 11/26/2019
• 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., Allan, James Calvin, Beasley, Rudolph A., Havel, William J., Schell, Jon D., Tran, Don H., Waldhauser, Steven L.
• Primary Examiner(s): Weare, Meredith
• Application Number:
  US13/482,883
• Publication Number:
  US 20130253346A1
• Time in Patent Office: 2,737 Days
• 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: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device, the kit comprising an outer sheath, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with a tapered distal end. The inner sheath is slidable within the inner lumen of the outer sheath and is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath. The kit includes an elongated deployment receptacle including a deployment bay slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath. The deployment bay carries an implantable medical device through the inner lumen of the outer sheath and facilitates deployment of the implantable medical device from the distal end 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 and a proximal opening, the outer sheath sized to traverse a vasculature of the patient;

an elongated inner sheath with a tapered distal end, wherein the tapered distal end is configured to substantially fill the inner lumen of the outer sheath and close-off the distal opening of the outer sheath, wherein the inner sheath is slidable within the inner lumen of the outer sheath, wherein the inner sheath is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath; and

an elongated deployment receptacle including a deployment bay at a distal end of the deployment receptacle and a proximal portion, wherein the deployment receptacle is slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath, wherein the deployment bay is configured to carry the implantable medical device through the inner lumen of the outer sheath and facilitate deployment of the implantable medical device out of the distal opening of the outer sheath, wherein the deployment bay includes a proximal wall that limits proximal movement of the implantable medical device relative to the elongated deployment receptacle while the implantable medical device is carried within the deployment bay, wherein a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay.

2. 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 tapered distal end of the inner sheath extends beyond the distal opening of the outer sheath.

3. The kit of claim 1, wherein the deployment receptacle further comprises a tether that is remotely controllable from a proximal end of the deployment receptacle to release the implantable medical device from the deployment bay.

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 deployment bay 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 deployment bay further includes pushing the implantable medical device out of the deployment bay with the helical element.

6. The kit of claim 1, further comprising:

a first coupling module slidably connected to the deployment receptacle; and

a mating coupling module secured to a proximal end of the outer sheath, wherein the mating coupling module is configured to connect to the first coupling module such that the deployment receptacle is axially aligned with the outer sheath,

wherein the deployment receptacle is slidable within the outer sheath while the first coupling module is connected to the mating coupling module.

7. The kit of claim 6,

wherein the mating coupling module includes a valve configured to prevent bodily fluids from exiting the patient through the inner lumen of the outer sheath,

wherein the valve is configured to open to allow the deployment receptacle to enter the inner lumen of the outer sheath.

8. The kit of claim 7, wherein the valve also opens to facilitate sliding the inner sheath out of the proximal opening of the outer sheath.

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

10. The kit of claim 9, 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.

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:

positioning a distal end of an elongated outer 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 and a proximal opening;

inserting an elongated deployment receptacle, including a deployment bay at a distal end of the deployment receptacle and a proximal portion, into the proximal opening of the outer sheath, wherein the implantable medical device is positioned within deployment bay, wherein the deployment bay includes a proximal wall that limits proximal movement of the implantable medical device relative to the elongated deployment receptacle while the implantable medical device is within the deployment bay, wherein a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay;

sliding the deployment receptacle through the inner lumen of the outer sheath until the deployment bay is adjacent to the distal opening of the outer sheath; and

deploying the implantable medical device from the deployment bay proximate to the target site within the patient.

17. The method of claim 16, further comprising:

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

sliding an assembly including an elongated inner sheath with a tapered distal end and the outer sheath over the guidewire to position the distal end of the assembly proximate to the target site within the patient,

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,

wherein, in the assembly, the inner sheath is within the lumen of the outer sheath and the tapered distal end of the inner sheath extends beyond the distal opening of the outer sheath.

18. The method of claim 16, wherein the deployment receptacle further comprises a tether that is remotely controllable from a proximal end of the deployment receptacle to release the implantable medical device from the deployment bay, the method further comprising remotely controlling the tether to deploy the implantable medical device from the deployment bay.

19. The method of claim 16, 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 16, 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.