IMPLANT SYSTEM INCLUDING GUIDING ACCESSORY AND METHODS OF USE

• US 20130035748A1
• Filed: 08/03/2011
• Published: 02/07/2013
• Est. Priority Date: 08/03/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonner, Matthew D., Nikolski, Vladimir P.
• Granted Patent: US 8,758,365 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A guiding accessory, for use in conjunction with a guidewire and a catheter of an implant system, facilitates passage of an elongate and flexible conductor of a relatively compact therapy delivery device to an implant site, for example, within the cardiac venous system, when a therapy generator of the device is held within a distal portion of the catheter, and the catheter, device and guiding accessory are advanced along the guidewire. The guiding accessory includes a helically extending wall that forms a lumen within which the device conductor and guidewire extend. After advancing the catheter, guiding accessory and device to the implant site, the helically extending wall is unwound from around the device conductor, for removal, preferably, by pulling proximally on a tension line, which is attached to a proximal end of the wall.

Claims

1. A method for delivering an implantable therapy delivery device alongside a guidewire to an implant site;

the device including a therapy generator, a therapy delivery element, and an elongate and flexible isolated conductor coupling the therapy generator to the therapy delivery element; and

the method comprising;

loading the elongate and flexible isolated conductor of the device within a lumen of a guiding accessory, the lumen being formed by a helically extending wall of the guiding accessory and the loading comprising inserting a distal end of the isolated conductor into a proximal opening of the lumen;

loading the therapy generator of the device within a distal portion of a catheter, the loading comprising inserting a proximal end of the generator into a distal opening of the distal portion;

loading the guidewire within a lumen of the catheter and within the lumen of the guiding accessory;

advancing a distal tip of the guidewire to a location in proximity to the implant site;

advancing the guiding accessory and the distal portion of the catheter along the advanced guidewire to the implant site, when the therapy generator of the device is loaded within the distal portion of the catheter and the conductor of the device is loaded within the lumen of the guiding accessory; and

after advancing the guiding accessory and the distal portion of the catheter, removing the helically extending wall of the guiding accessory from around the loaded conductor of the device by drawing a proximal end of the wall toward the distal opening of the distal portion of the catheter and proximally therefrom, thereby unwinding the wall from around the conductor.

2. The method of claim 1, wherein drawing the proximal end of the helically extending wall comprises pulling on a proximal end of a tension line of the guiding accessory, a distal end of the tension line being coupled to the proximal end of the wall.

3. The method of claim 2, wherein the tension line extends within another lumen of the catheter, and pulling on the tension line draws the unwound wall into the other lumen.

4. The method of claim 1, further comprising pushing the generator of the device out from the distal portion of the catheter, through the distal opening of the distal portion, after advancing the distal portion of the catheter, and in conjunction with drawing the proximal end of the helically extending wall toward the distal opening of the distal portion.

5. The method of claim 1, wherein loading the guidewire follows advancing the distal tip of the guidewire to the location just distal to the implant site, and loading the guidewire comprises inserting a proximal end of the guidewire into a distal opening and then out from a proximal opening of the lumen of the guiding accessory, and into a distal opening and out from a proximal opening of the lumen of the catheter, the distal and proximal openings of the lumen of the catheter being located in proximity to the distal portion of the catheter.

6. The method of claim 1, wherein the implant site is at least partially located within a cardiac vein.

7. The method of claim 6, wherein the implant site is further located in a right atrium, in proximity to an ostium of a coronary sinus.

8. The method of claim 6, wherein the cardiac vein is one extending along a left ventricular wall, and the implant site is further located in a coronary sinus.

9. A system comprising a guidewire, a catheter and a guiding accessory for implanting a therapy delivery device;

the device including a therapy generator, a therapy delivery element, and an elongate and flexible isolated conductor coupling the therapy generator to the therapy delivery element;

the catheter including a lumen sized to accommodate passage of the guidewire and a distal portion sized to hold the therapy generator of the device, the distal portion having a distal opening through which the elongate and flexible isolated conductor of the device extends outside of, and generally distal of the distal portion, when the distal portion holds the therapy generator; and

the guiding accessory comprising;

a helically extending wall forming a lumen that extends along a length from a proximal opening thereof to a distal opening thereof, the lumen having a diameter sized to accommodate therein the guidewire and the elongate and flexible isolated conductor of the device, side-by-side, such that the guidewire is slidable within the lumen alongside the conductor, and such that the wall and the conductor together are moveable along the guidewire; and

a tension line attached to a proximal end of the wall, the tension line having a length that is greater than a length of the implant catheter; and

wherein adjacent turns of the helically extending wall are separable from one another so that, upon application of a pull force through the tension line, in a proximal direction, when the conductor of the device extends within the lumen, the wall unwinds from around the conductor.

10. The system of claim 9, wherein the lumen of the catheter extends alongside the distal portion thereof and includes a proximal opening and a distal opening, both located in proximity to the distal portion.

11. The system of claim 9, wherein the catheter includes another lumen and the tension line of the guiding accessory extends within the other lumen.

12. The system of claim 11, wherein the other lumen opens into the distal portion of the catheter, and the tension line extends alongside the therapy generator of the device, when the distal portion holds the therapy generator.

13. The system of claim 11, wherein the other lumen is sized to receive the helically extending wall of the guiding accessory as the pull force is applied through the tension line to unwind the wall.

14. The system of claim 9, wherein the helically extending wall of the guiding accessory is formed from a spiral-cut polymer tube.

15. The system of claim 9, wherein the helically extending wall of the guiding accessory is formed from a coiled strip of one or a combination of:

a resilient polymer and a resilient metal.

16. A guiding accessory for use in conjunction with a guidewire and a catheter to facilitate passage of a portion of a therapy delivery device to an implant site;

the device including a therapy generator, a therapy delivery element, and an elongate and flexible isolated conductor coupling the therapy generator to the therapy delivery element;

the catheter including a distal portion sized to hold the therapy generator of the device, the distal portion having an opening through which the elongate and flexible isolated conductor of the device extends outside of, and generally distal of, the distal portion, when the distal portion holds the therapy generator; and

the guiding accessory comprising;

a helically extending wall forming a lumen that extends along a length from a proximal opening thereof to a distal opening thereof, the lumen having a diameter sized to accommodate therein the guidewire and the elongate and flexible isolated conductor of the device, side-by-side, such that the guidewire is slidable within the lumen alongside the isolated conductor, and such that the wall and the conductor together are moveable along the guidewire; and

a tension line attached to a proximal end of the helically extending wall, the tension line having a length that is greater than a length of the implant catheter; and

wherein adjacent turns of the helically extending wall are separable from one another so that, upon application of a pull force to the tension line, in a proximal direction, when the conductor of the device extends within the lumen, the wall unwinds from around the conductor.

17. The accessory of claim 16, wherein the helically extending wall is formed from a spiral-cut polymer tube.

18. The accessory of claim 16, wherein the helically extending wall is formed from a coiled strip of one or a combination of:

a resilient polymer and a resilient metal.

19. The accessory of claim 16, wherein the tension line is sized to pass within another lumen of the catheter.