Delivery device having a deflectable and peelable mapping guide sheath for his bundle pacing

Patent metadata

Field	Value
Publication number	US-11413454-B2
Application number	US-201916452223-A
Country	US
Kind code	B2
Filing date	Jun 25, 2019
Priority date	Jun 25, 2019
Publication date	Aug 16, 2022
Grant date	Aug 16, 2022

Abstract

A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.

First claim

The invention claimed is:

1. A delivery device for delivering a pacing lead to the His bundle of a patient's heart, the delivery device comprising:
a handle;
an elongated sheath having a proximal end connected to the handle and a distal end remote from the handle, a distal portion of the sheath having a plurality of flexible sections spaced from one another along a length of the sheath, the sheath including an inner layer having a longitudinal rib that protrudes radially outward from an outer surface of the inner layer, the longitudinal rib extending from the proximal end to the distal end, the sheath being splittable along a first split line from the proximal end to the distal end; a pull wire having a distal end connected to the sheath distally of the flexible sections and extending to a proximal end; and a plurality of mapping electrodes positioned at the distal end of the sheath, wherein the sheath further includes an outer layer having a recess facing radially inward and mating with the rib, the first split line aligned with the rib and the recess to facilitate splitting of the sheath.

2. The delivery device as claimed in claim 1 , wherein the plurality of mapping electrodes comprise two electrodes that are spaced between 1 mm and 3 mm in a circumferential direction of the sheath.

3. The delivery device as claimed in claim 1 , wherein the distal end of the sheath has a distal end face, and the mapping electrodes are exposed on the distal end face.

4. The delivery device as claimed in claim 1 , wherein the flexible sections of the sheath have a first Shore D hardness which is less than a second Shore D hardness of remaining sections of the sheath.

5. The delivery device as claimed in claim 4 , wherein the flexible sections of the sheath have a Shore D hardness of between 20 and 40.

6. The delivery device as claimed in claim 5 , wherein the flexible sections of the sheath have a Shore D hardness of 35.

7. The delivery device as claimed in claim 4 , wherein the remaining sections of the sheath have a Shore D hardness of between 60 and 100.

8. The delivery device as claimed in claim 7 , wherein the remaining sections of the sheath have a Shore D hardness of between 70 and 75.

9. The delivery device as claimed in claim 1 , further comprising a hub at the proximal end of the sheath, the hub having a weakened region defining a second split line longitudinally aligned with the first split line in the sheath.

10. The delivery device as claimed in claim 1 , wherein the handle includes a proximal handle portion and a distal handle portion, the proximal handle portion being connected to the distal handle portion by a rail so as to define a space between the proximal handle portion and the distal handle portion.

11. The delivery device as claimed in claim 10 , further comprising a rotatable actuator positioned in the space and connected to the proximal handle portion and the distal handle portion, rotation of the actuator in a first direction bending the flexible sections of the sheath toward a dual hinged configuration and rotation of the actuator in an opposite direction moving the sheath toward a substantially straight configuration.

12. The delivery device as claimed in claim 1 , wherein the sheath has a second longitudinal rib extending from the proximal end to the distal end, the second longitudinal rib being diametrically opposed to the first longitudinal rib, the sheath being splittable along a second split line from the proximal end to the distal end, the second split line aligned with the second longitudinal rib.

13. The delivery device as claimed in claim 1 , wherein the sheath includes an inner layer formed from polytetrafluorethylene.

14. The delivery device as claimed in claim 1 , wherein the sheath further includes a middle layer, the longitudinal rib extending through the middle layer.

15. The delivery device of claim 1 , wherein the pull wire is configured to deflect the distal portion of the sheath to locate the plurality of mapping electrodes proximate to the His bundle.

16. The delivery device of claim 1 , wherein the distal portion of the sheath is configured to pass through a vascular access site into the right atrium (RA) and the pull wire is configured to deflect the distal portion of the sheath to locate the plurality of mapping electrodes proximate to the His bundle.

17. The delivery device of claim 1 , wherein the sheath includes at least two of the inner layer, a middle layer and the outer layer, the rib extending along one of the inner layer or middle layer, the recess provided in another of the middle layer or outer layer, the rib and recess mating with one another.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Guo Xiaoping
• Stoermer Erich W

Classifications

• A61N1/056 Primary

  Transvascular endocardial electrode systems · CPC title

• A61M2025/0681

  Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube · CPC title

• A61N1/059 Primary

  Anchoring means · CPC title

• A61M25/0668

  splittable, tear apart · CPC title

• A61M25/0108

  using radio-opaque or ultrasound markers · CPC title