Search

EP-4740998-A1 - SYSTEMS FOR IMPLANTING MEDICAL DEVICES

EP4740998A1EP 4740998 A1EP4740998 A1EP 4740998A1EP-4740998-A1

Abstract

An attachment device (250) for coupling a biostimulator (200) to a delivery system (100) includes a case (502), a tether dock (504), and a filament (506). The case (502) has a wall (516), a first end (512), and a second end (514) opposite the first end (512). The wall (516) defines a passage (508) and a slot (510). The passage (508) extends between the first end (512) and the second end (514). The slot (510) extends through the wall (516) such that the passage (508) is accessible through the slot (510). The tether dock (504) extends from second end (514) of the case (502). The tether dock (504) defines a groove (524) extending therethrough. The filament (506) has a fixed end (526) and free end (528). The fixed end (526) is attached to the first end (521) of the case (502). The free end (528) includes a bulb (530) that is selectively receivable in the passage (508) of the case (502) through the slot (510).

Inventors

  • GULSETH, Jared
  • BLUE, JEREMIAH
  • WEBER, ADAM
  • PIKUS, Michael J

Assignees

  • Pacesetter, Inc.

Dates

Publication Date
20260513
Application Date
20251112

Claims (15)

  1. An attachment device (250) for coupling a biostimulator (200) to a delivery system (100), the attachment device (250) comprising: a case (502) having a wall (516), a first end (512), and a second end (514) opposite the first end (512), the wall (516) defining a passage (508) and a slot (510), the passage (508) extending between the first end (512) and the second end (514), the slot (510) extending through the wall (516) such that the passage (508) is accessible through the slot (510); a tether dock (504) extending from the second end (514) of the case (502), the tether dock (504) defining a groove (524) extending therethrough; and a filament (506) having a fixed end (526) and a free end (528), the fixed end (526) attached to the first end (512) of the case (502), the free end (528) including a bulb (530) that is selectively receivable in the passage (508) of the case (502) through the slot (510).
  2. The attachment device of claim 1, wherein the groove (524) is aligned with the slot (510) of the case (502).
  3. The attachment device according to claim 1 or 2, wherein the tether dock (504) is configured to receive a tether (204) of the delivery system (100) within the groove (524) to couple the attachment device (250) to the delivery system (100).
  4. The attachment device according to any one of claims 1 to 3, wherein the filament (506) is configured to secure the biostimulator (200) to the delivery system (100) when the bulb (530) is received within the passage (508) of the case (502), and wherein the filament (506) is configured to release the biostimulator (200) from the delivery system (100) when the bulb (530) is outside of the passage (508) of the case (502).
  5. The attachment device according to any one of claims 1 to 4, wherein the slot (510) of the case (502) is defined to have a first portion (518) and a second portion (520) that is wider than the first portion.
  6. The attachment device according to claim 5, wherein the bulb (530) has a width less than the width of the second portion (520) of the slot (510) such that the bulb (530) can pass therethrough.
  7. The attachment device according to any one of claims 1 to 6, wherein the filament (506) is made of a metallic material.
  8. The attachment device according to any one of claims 1 to 6, wherein the filament (506) is made of a fibrous, polymeric, non-metallic material.
  9. The attachment device according to any one of claims 1 to 8, further comprising a biostimulator (200) secured to the attachment device (250).
  10. The attachment device according to claim 9, further comprising a holding tool (1402), the attachment device (250) and the biostimulator (200) contained within the holding tool (1402), the holding tool (1402) configured to guide a tether (204) of the delivery system (100) into the tether dock (504) of the attachment device (250) to couple the attachment device (250) and the biostimulator (200) to the delivery system (100).
  11. A system comprising: a catheter (102) having a proximal end and a distal end opposite the proximal end, the catheter (102) including a docking cap (122) disposed on the distal end of the catheter (102); a tether catheter (202) disposed within and extending through the catheter (102); a tether (204) disposed within and extending through the tether catheter (202); a biostimulator (200) including an attachment member (308); and the attachment device (250) according to any one of claims 1 to 10, wherein the attachment device (250) has a docked configuration in which the attachment device (250) is disposed within the catheter (102) at a first position such that the biostimulator (200) is engaged with the docking cap (122), a tethered configuration in which the attachment device (250) is disposed within the catheter (102) at a second position distal from the first position such that the biostimulator (200) is disengaged with the docking cap (122) and the bulb (530) of the filament (506) remains within the catheter (102), and a release configuration in which the attachment device (250) is disposed within the catheter (102) at a third position distal from the second position such that the bulb (530) of the filament (506) is outside the catheter (102) and removable from the passage (508) of the case (502).
  12. The system according to claim 11, wherein the tether (204) includes a bullet (206) at a distal end of the tether (204), the bullet (206) having a diameter larger than a diameter of the tether (204).
  13. The system according to claim 12, wherein the bullet (206) has a capsule shape.
  14. The system according to any one of claims 11 to 13, wherein the attachment member (308) of the biostimulator (200) defines a hole (310) extending therethrough, the filament (506) passing through the hole (310) to secure the biostimulator (200) to the attachment device (250) when the attachment device (250) is in the docked configuration or the tethered configuration.
  15. The system according to claim 14, wherein the filament (506) can be withdrawn from the hole (310) of the attachment member (308) when the attachment device (250) is in the release configuration to decouple the biostimulator (200) from the tether catheter (202).

Description

Technical Field The present disclosure relates to implantable medical devices and related delivery and retrieval systems. More specifically, the present disclosure relates to devices for delivering and retrieving biostimulators, such as leadless cardiac pacemakers, via a catheter-based delivery system. Background Cardiac pacing by an artificial pacemaker provides an electrical stimulation of the heart when its own natural pacemaker and/or conduction system fails to provide synchronized atrial and ventricular contractions at rates and intervals sufficient for a patient's health. Such antibradycardial pacing provides relief from symptoms and even life support for hundreds of thousands of patients. Cardiac pacing may also provide electrical overdrive stimulation to suppress or convert tachyarrhythmias, again supplying relief from symptoms and preventing or terminating arrhythmias that could lead to sudden cardiac death. Cardiac pacing may be performed by several implantable medical devices including, but not limited to, electrocardiographs ("ECGs"), electroencephalographs ("EEGs"), squid magnetometers, implantable pacemakers, implantable cardioverter-defibrillators ("ICDs"), neurostimulators, electrophysiology ("EP") mapping and radio frequency ("RF") ablation systems, and the like. Hereinafter these cardiac pacing devices may generally be referred to as a biostimulator. Biostimulators are typically delivered to an intracardial implant site via a delivery system including catheters, sheaths, and/or introducers. In general, a biostimulator may be connected to a catheter in a docked configuration, in which the biostimulator is securely attached to the catheter. In the docked configuration, the catheter may be operated to guide the biostimulator to an implant site. Once the biostimulator is proximate to the implant site, the delivery system may be used to implant the biostimulator into the tissue of the patient. Once the biostimulator is secured into the tissue, the biostimulator may be moved into a tethered configuration. In the tethered configuration, the delivery system separates from the biostimulator, but remains connected to the biostimulator. For example, two separate and distinct tethers may connect the biostimulator to the catheter in the tethered stated. In the tethered state, an implanting physician may test the biostimulator to make sure that the biostimulator is securely and electrically connected to patient tissue at a desired location. If the physical and/or electrical connection between the biostimulator and the patient tissue is less than optimal, the biostimulator may be re-docked to the catheter so that that the biostimulator may be moved to a better position for implantation. Once the implanting physician is satisfied with the location of the biostimulator within the patient anatomy, the biostimulator is transitioned from the tethered configuration to a release configuration. During the release configuration, the biostimulator disconnects from the catheter. Summary Existing systems and methods, such as those described above, may be susceptible to inadvertent release. Specifically, the tethers may inadvertently release from an attachment feature of the biostimulator during implantation before the implanting physician desires to release the biostimulator from the catheter. Additionally or alternatively, the tethers may become entangled with one another. Entanglement of the tethers may cause inadvertent release or may prevent release of the biostimulator altogether. Accordingly, there is a need for a catheter system that can reliably and predictably couple and decouple to biostimulators. This disclosure relates generally to catheter-based delivery systems and devices for catheter-based delivery systems that tether to biostimulators without inadvertent release or entanglement. Specifically, this disclosure relates to attachment devices that couple a catheter-based delivery system to a biostimulator using a single filament and a single tether. In an aspect of the present disclosure, an attachment device for coupling a biostimulator to a delivery system includes a case, a tether dock, and a filament. The case has a wall, a first end, and a second end opposite the first end. The wall defines a passage and a slot. The passage extends between the first end and the second end. The slot extends through the wall such that the passage is accessible through the slot. The tether dock extends from the second end of the case. The tether dock defines a groove extending therethrough. The groove is aligned with the slot of the case. The filament has a fixed end and a free end. The fixed end is attached to the first end of the case. The free end includes a bulb that is selectively receivable in the passage of the case through the slot. In an embodiment, the groove is aligned with the slot of the case. In an embodiment, the tether dock is configured to receive a tether of the delivery system within the groove to co