Delivery Catheter Systems and Methods

• US 20120197373A1
• Filed: 12/13/2011
• Published: 08/02/2012
• Est. Priority Date: 12/13/2010
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Nanostim, Inc (Abbott Laboratories)
• Inventors: Khairkhahan, Alexander, Klenk, Alan
• Granted Patent: US 8,615,310 B2
• Time in Patent Office: Days
• US Class Current: 607/127
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

A delivery system for implanting a leadless cardiac pacemaker into a patient is provided. The cardiac pacemaker can include a docking or delivery feature having a through-hole disposed on or near a proximal end of the pacemaker for attachment to the delivery system. In some embodiments, the delivery catheter can include first and second tethers configured to engage the delivery feature of the pacemaker. The tethers, when partially aligned, can have a cross-sectional diameter larger than the through-hole of the delivery feature, and when un-aligned, can have a cross-sectional diameter smaller than the through-hole of the delivery feature. Methods of delivering the leadless cardiac pacemaker with the delivery system are also provided.

Claims

1. A delivery catheter for implanting a medical device, comprising:

a handle;

a catheter shaft coupled to the handle;

a first tether disposed within the catheter shaft and extending distally beyond the catheter shaft, the first tether including a first locking feature positioned near a distal portion of the first tether;

a second tether disposed within the catheter shaft and extending distally beyond the catheter shaft, the second tether including a second locking feature positioned near a distal portion of the second tether;

a tether adjustment feature coupled to the first tether, the tether adjustment feature configured to adjust a length of the first tether extending distally beyond the catheter shaft.

2. The delivery catheter of claim 1 wherein the delivery catheter comprises an aligned configuration where the first and second locking features are positioned at least partially side by side, and an un-aligned configuration where the first and second locking features are not positioned side by side.

3. The delivery catheter of claim 2 wherein the tether adjustment feature facilitates switching the delivery catheter between the aligned configuration and the un-aligned configuration.

4. The delivery catheter of claim 1 further comprising:

a docking cap disposed on a distal portion of the catheter shaft; and

a torque shaft disposed within the catheter shaft, the torque shaft coupled to the docking cap, the torque shaft being configured to apply rotational torque to the docking cap to rotate the docking cap.

5. The delivery catheter of claim 1 further comprising a protective sheath disposed on the catheter shaft, the protective sheath being slideably along the catheter shaft and comprising a crease that runs longitudinally along the protective sheath, wherein the protective sheath is configured to be folded over itself along the crease to reduce a delivery diameter of the protective sheath.

6. A leadless pacemaker and delivery system, comprising:

a leadless cardiac pacemaker comprising an attachment feature disposed on a proximal portion of the pacemaker, the attachment feature including a through-hole having a first diameter; and

a delivery catheter comprising;

a handle;

a catheter shaft coupled to the handle;

a first tether disposed within the catheter shaft and extending distally beyond the catheter shaft, the first tether including a first locking feature positioned near a distal portion of the first tether;

a second tether disposed within the catheter shaft and extending distally beyond the catheter shaft, the second tether including a second locking feature positioned near a distal portion of the second tether; and

a tether adjustment feature coupled to the first tether, the tether adjustment feature configured to adjust a position of the first locking feature with respect to the second locking feature;

the delivery catheter comprising an aligned configuration where a portion of the first locking feature is longitudinally aligned with a portion the second locking feature and comprises a combined cross-sectional diameter larger than the first diameter of the through-hole, the delivery catheter also comprising an un-aligned configuration where the first locking feature is not longitudinally aligned with the second locking feature and comprises a combined cross-sectional diameter smaller than the first diameter of the through-hole.

7. The delivery catheter of claim 6 wherein the tether adjustment feature facilitates switching the delivery catheter between the aligned configuration and the un-aligned configuration.

8. The delivery catheter of claim 6 further comprising:

a docking cap disposed on a distal portion of the catheter shaft; and

a torque shaft disposed within the catheter shaft, the torque shaft coupled to the docking cap, the torque shaft being configured to apply rotational torque to the docking cap to rotate the docking cap.

9. The delivery catheter of claim 6 further comprising a protective sheath disposed on the catheter shaft, the protective sheath being slideably along the catheter shaft and comprising a crease that runs longitudinally along the protective sheath, wherein the protective sheath is configured to be folded over itself along the crease to reduce a delivery diameter of the protective sheath.

10. A method of delivering a medical device to a patient with a delivery catheter, comprising:

positioning an attachment feature of the medical device in proximity to an attachment mechanism of the delivery catheter;

inserting the attachment mechanism of the delivery catheter distally through a hole in the attachment feature of the medical device, the attachment mechanism having a cross-sectional diameter smaller than a diameter of the hole;

increasing the cross-sectional diameter of the attachment mechanism to prevent the attachment mechanism from moving proximally back through the hole of the attachment feature of the medical device.

11. The method of claim 10 wherein the attachment feature comprises a pair of tethers disposed within and extending distally beyond the delivery catheter, each of the tethers having a locking feature.

12. The method of claim 11 wherein the attachment feature has a cross-sectional diameter smaller than the diameter of the hole when portions of the locking features of the tethers are not longitudinally aligned.

13. The method of claim 11 wherein the increasing the cross-sectional diameter step comprises longitudinally aligning at least a portion of the locking features of the tethers.

14. The method of claim 10 wherein the medical device comprises a leadless cardiac pacemaker.

15. The method of claim 10 further comprising pulling the medical device proximally with the attachment mechanism to place the medical device in contact with a distal end of the delivery catheter.

16. The method of claim 15 further comprising inserting the medical device and the delivery catheter into the patient adjacent to an implantation site, and applying rotational torque from the delivery catheter to the medical device to screw a fixation device of the medical device into the implantation site.

17. A method of delivering a leadless pacemaker to a patient with a delivery catheter, comprising:

positioning a first locking feature of a first tether of the delivery catheter at a longitudinal position different than that of a second locking feature of a second tether of the delivery catheter, so that a combined cross-sectional diameter of the locking features is less than a cross-sectional diameter of a hole in an attachment feature of the leadless pacemaker;

inserting the first and second locking features through the hole in the attachment feature of the leadless pacemaker; and

aligning a portion of the first locking feature at the same longitudinal position than that of a portion of the second locking feature, so that the combined cross-sectional diameter of the locking features and tethers is greater than the cross-sectional diameter of the hole in the attachment feature of the leadless pacemaker.

18. The method of claim 17 further comprising pulling the medical device proximally with the first and second tethers to place the leadless pacemaker in contact with a distal end of the delivery catheter.

19. The method of claim 18 further comprising inserting the medical device and the delivery catheter into the patient adjacent to an implantation site, and applying rotational torque from the delivery catheter to the leadless pacemaker to screw a fixation device of the pacemaker into the implantation site.