Deflectable mapping guide sheath for his bundle pacing

Patent metadata

Field	Value
Publication number	US-11890100-B2
Application number	US-202217877408-A
Country	US
Kind code	B2
Filing date	Jul 29, 2022
Priority date	Feb 16, 2018
Publication date	Feb 6, 2024
Grant date	Feb 6, 2024

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 tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. 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 straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

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 in series from the distal end a first relatively rigid section, a first relatively flexible section, a second relatively rigid section, a second relatively flexible section and a third relatively rigid section, the first relatively flexible section being spaced apart from the second relatively flexible section such that the distal portion is deflectable to a dual hinged configuration, the first, second, and third relatively rigid sections being formed from a first polymer having a first Shore D hardness, and the first and second relatively flexible sections being formed from a second polymer having a second Shore D hardness less than the first Shore D hardness;
a pull wire having a distal end connected to the sheath distally of the first relatively flexible section and extending to a proximal end of the pull wire; and
a plurality of mapping electrodes positioned at the distal end of the sheath,
wherein the distal end of the sheath has a distal tip, and the mapping electrodes include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath.

2. The delivery device as claimed in claim 1 , wherein the two electrodes are spaced apart by 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 distal end of the sheath has a distal end face, and the mapping electrodes are spaced from the distal end face.

5. The delivery device as claimed in claim 1 , wherein the second Shore D hardness is between 20 and 40.

6. The delivery device as claimed in claim 1 , wherein the second Shore D hardness is 35.

7. The delivery device as claimed in claim 1 , wherein the first Shore D hardness is between 60 and 100.

8. The delivery device as claimed in claim 1 , wherein the first Shore D hardness is between 70 and 75.

9. The delivery device as claimed in claim 1 , wherein the sheath has a substantially straight configuration in an initial condition and the dual hinged configuration in a use condition.

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.

12. The delivery device of claim 11 , wherein rotation of the actuator in a first direction moves the sheath toward a use condition and rotation of the actuator in an opposite direction moves the sheath toward an initial condition.

13. 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;
a pull wire having a distal end connected to the sheath distally of the flexible sections and extending to a proximal end of the pull wire; and
a plurality of mapping electrodes positioned at the distal end of the sheath,
wherein the handle has a longitudinal axis and the proximal end of the sheath enters the handle at a first position at a predetermined angle transverse to the longitudinal axis and exits the handle at a second position at the predetermined angle transverse to the longitudinal axis, and
wherein the distal end of the sheath has a distal end face, and the plurality of mapping electrodes are spaced from the distal end face.

14. The delivery device as claimed in claim 13 , wherein a distal end of the sheath has a distal tip, and the plurality of mapping electrodes include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath.

15. The delivery device as claimed in claim 14 , wherein the two electrodes are spaced apart by between 1 mm and 3 mm in a circumferential direction of the sheath.

16. The delivery device as claimed in claim 13 , 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.

17. The delivery device as claimed in claim 16 , further comprising a rotatable actuator positioned in the space and connected to the proximal handle portion and the distal handle portion.

18. 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, the distal end having a distal tip, a distal portion of the sheath having a plurality of flexible sections spaced from one another along a length of the sheath;
a pull wire having a distal end connected to the sheath distally of the flexible sections and extending to a proximal end of the pull wire; and
a plurality of mapping electrodes positioned at the distal end of the sheath, the mapping electrodes including two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath,
wherein the distal portion of the sheath is deflectable within a deflection plane, and the two electrodes lie within the deflection plane when the distal portion of the sheath is deflected.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Kramer Scott A
• Stoermer Erich W
• Conway Joshua C
• Bornzin Gene A
• Somogyi Zoltan
• Hanenburg Amy L
• Weiss Emily
• Belk Paul A
• Senarith Patrick P

Classifications

• A61B5/318 Primary

  Heart-related electrical modalities, e.g. electrocardiography [ECG] · CPC title

• A61B5/287

  Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] · CPC title

• A61M25/0136

  Handles therefor · CPC title

• A61M25/0147

  with movable mechanical means, e.g. pull wires · CPC title

• A61N1/056

  Transvascular endocardial electrode systems · CPC title