US-12622727-B2 - Flexible torque cable for delivery of medical devices

Abstract

The present disclosure describes delivery cables for delivering a medical device and methods of making and employing the same. In one embodiment, a delivery cable includes a flexible inner core, a proximal outer coil, and a distal outer coil. The proximal outer coil has a first rigidity. The distal outer coil surrounds at least a portion of a distal section of the flexible inner core and has a second rigidity less than the first rigidity thereby, thereby reducing bias placed on the medical device by the delivery cable during deployment of the medical device. Relative dimensions of an outer diameter of the distal outer coil and an inner diameter of a delivery sheath for deploying the delivery cable reduce snaking of the delivery cable within the delivery sheath.

Inventors

• Brian Perszyk
• Caytlin Gale

Assignees

• ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Dates

Publication Date

20260512

Application Date

20231010

Claims (19)

1. 1 . A method for implanting a medical device at a target site in a subject using a delivery cable and a delivery sheath, the method comprising: deploying the delivery sheath into the subject; advancing the delivery cable through the deployed delivery sheath, the delivery cable including a flexible inner core, a proximal outer coil having a first rigidity, and a distal outer coil surrounding at least a portion of a distal section of the flexible inner core and having a second rigidity less than the first rigidity, wherein relative dimensions of an outer diameter of the distal outer coil and an inner diameter of the delivery sheath reduce snaking of the delivery cable within the delivery sheath; continuing to advance the delivery cable until the medical device exits the delivery sheath and reaches the target site, wherein the distal outer coil and flexible inner core reduce bias placed on the medical device by the delivery cable when the distal outer coil is in a bent configuration; and deploying the medical device at the target site by detaching the medical device from the delivery cable, wherein the proximal outer coil and the distal outer coil are formed as separate members with a distal end of the proximal outer coil being coupled to a proximal end of the distal outer coil, wherein the distal end of the proximal outer coil is coupled to the proximal end of the distal outer coil via a first coupler.
2. 2 . The method of claim 1 , wherein the outer diameter of the distal outer coil is less than the inner diameter of the delivery sheath and greater than 50% of the inner diameter of the delivery sheath.
3. 3 . The method of claim 1 , wherein advancing the delivery cable comprises imparting reduced force on the delivery cable to perform the advancing, compared to a delivery cable with dissimilar relative dimensions.
4. 4 . The method of claim 1 , wherein a length of the distal outer coil is between approximately 0.5 inches (12.7 mm) and 3.0 inches (76.2 mm).
5. 5 . The method of claim 1 , wherein deploying the medical device comprises deploying a septal occluder.
6. 6 . The method of claim 1 , further comprising coupling the medical device to an endscrew of the delivery cable, the endscrew coupled to a distal end of the flexible inner core.
7. 7 . The method of claim 6 , wherein detaching the medical device from the delivery cable comprises decoupling the medical device from the endscrew.
8. 8 . The method of claim 1 , wherein deploying the medical device further comprises at least partially recapturing the medical device within the delivery sheath prior to detaching the medical device from the delivery cable.
9. 9 . The method of claim 8 , further comprising repositioning the medical device within the target site after said at least partially recapturing the medical device.
10. 10 . The method of claim 1 , further comprising coupling the medical device to a distal end of the delivery cable prior to said deploying the delivery sheath.
11. 11 . The method of claim 1 , wherein the distal outer coil comprises at least one first wound wire having a first wire diameter, and wherein the proximal outer coil comprises at least one second wound wire having a second wire diameter greater than the first wire diameter.
12. 12 . The method of claim 1 , wherein the outer diameter of the distal outer coil is approximately equal to an outer diameter of the proximal outer coil.
13. 13 . The method of claim 1 , wherein the outer diameter of the distal outer coil is greater than an outer diameter of the proximal outer coil.
14. 14 . The method of claim 1 , wherein a heat shrink material circumscribes at least a portion of both the proximal outer coil and the distal outer coil.
15. 15 . The method of claim 1 , wherein the delivery cable includes an intermediate outer coil, the proximal outer coil and the intermediate outer coil being coupled to one another via the first coupler, and the intermediate outer coil and the distal outer coil being coupled to one another via a second coupler.
16. 16 . The method of claim 1 , wherein the flexible inner core comprises a proximal flexible inner core, an intermediate flexible inner core, and a distal flexible inner core.
17. 17 . The method of claim 16 , wherein the proximal flexible inner core and the intermediate flexible inner core are coupled to one another via the first coupler, and wherein the intermediate flexible inner core and the distal flexible inner core are coupled to one another via a second coupler.
18. 18 . The method of claim 1 , wherein the distal outer coil includes a transition section, and wherein the distal outer coil has a varying rigidity along the transition section.
19. 19 . The method of claim 1 , wherein the distal outer coil is a tapered wire wound into a coil.

Description

CROSS REFERENCE OF RELATED APPLICATIONS This application is a divisional application of U.S. patent application Ser. No. 17/161,416, filed on Jan. 28, 2021, which is a divisional application of U.S. patent application Ser. No. 15/903,432, filed on Feb. 23, 2018, and issued as U.S. Pat. No. 10,925,640 on Feb. 23, 2021, which claims priority to U.S. Provisional Application Ser. No. 62/462,661, filed Feb. 23, 2017; 62/478,883, filed Mar. 30, 2017; and 62/503,061, filed May 8, 2017, each of which are incorporated by reference herein in their entirety. BACKGROUND OF THE DISCLOSURE Field of Disclosure The present disclosure generally relates to a medical device delivery cable and methods of making and using the same. In particular, the present disclosure relates to a medical device delivery cable including a flexible inner member, a proximal outer member to provide column strength and rigidity to the delivery cable, and a distal outer member to provide flexibility to the delivery cable. Methods of manufacturing and using the medical device delivery cables are also disclosed. Background Art Delivery devices including, among other components, catheters and delivery cables are used for an ever-growing number of procedures, and in particular, for the delivery of medical devices to a target site. Typically, the catheter is manipulated through the patient's vasculature and to the intended site, for example, a site within the patient's heart or other organ and the delivery cable is used to advance the medical device through the catheter and to the target site. Once the medical device has reached the target site, the delivery cable may be detached or uncoupled from the medical device such that the medical device is deployed from both the catheter and the delivery cable. Generally, the catheter would have an overall outside diameter small enough to negotiate blood vessels or other anatomy while retaining an inner diameter (“bore size”) large enough to accommodate the medical device (and delivery cable) therethrough. Since the path within the patient may be long, tortuous, and/or involve intricate placement of a medical device(s), maneuverability via steering the catheter may be particularly beneficial. Furthermore, the delivery cable must be rigid enough so as to be capable of maneuvering the medical device through the catheter while still being flexible enough to accommodate the tortuous path through which it must travel to the target site. SUMMARY OF THE DISCLOSURE The present disclosure is directed to a delivery cable that includes a flexible inner core, a proximal outer coil having a first rigidity, and a distal outer coil surrounding at least a portion of a distal section of the flexible inner core and having a second rigidity less than the first rigidity, thereby reducing bias placed on the medical device by the delivery cable. The present disclosure is further directed to a delivery device for delivering a medical device to a target site, the delivery device including an outer sheath, and a delivery cable positioned within the outer sheath and movable along a longitudinal axis with respect to the outer sheath. The delivery cable includes a flexible inner core, a proximal outer coil having a first rigidity, and a distal outer coil surrounding at least a portion of a distal section of the flexible inner core and having a second rigidity less than the first rigidity, thereby reducing bias placed on the medical device by the delivery cable. The present disclosure is further directed to a method for implanting a medical device at a target site in a subject using a delivery cable and a delivery sheath. The method includes deploying the delivery sheath into the subject. The method further includes advancing the delivery cable through the deployed delivery sheath, the delivery cable including a flexible inner core, a proximal outer coil having a first rigidity, and a distal outer coil surrounding at least a portion of a distal section of the flexible inner core and having a second rigidity less than the first rigidity, wherein relative dimensions of an outer diameter of the distal outer coil and an inner diameter of the delivery sheath reduce snaking of the delivery cable within the delivery sheath. The method further includes continuing to advance the delivery cable until the medical device exits the delivery sheath and reaches the target site, wherein the distal outer coil and flexible inner core reduce bias placed on the medical device by the delivery cable when the distal outer coil and flexible inner core are in a bent configuration. The method further includes deploying the medical device at the target site by detaching the medical device from the delivery cable. The present disclosure is also directed to a method of forming a delivery cable. The method includes providing a flexible inner member, inserting the inner member at least partially into a proximal outer member having a first rigidity, and coupling the inner