Bendable sheath and delivery system using bendable sheath

Patent metadata

Field	Value
Publication number	US-11938283-B2
Application number	US-202017010415-A
Country	US
Kind code	B2
Filing date	Sep 2, 2020
Priority date	Jan 3, 2018
Publication date	Mar 26, 2024
Grant date	Mar 26, 2024

Abstract

A bendable sheath and a delivery system using the bendable sheath. The bendable sheath comprises a tube body ( 3 ). The tube body ( 3 ) comprises a distal end and a proximal end. A tube wall of the tube body ( 3 ) is connected to a pull wire ( 8 ). One end of the pull wire ( 8 ) extends towards the proximal end of the tube body ( 3 ), and the other end is connected to the tube body ( 3 ) near the distal end of the tube body ( 3 ). The pull wire ( 8 ) comprises at least a section thereof disposed freely outside the tube body ( 3 ) and near the distal end of the tube body ( 3 ). The pull wire ( 8 ) in the bendable sheath comprises the section disposed freely outside the sheath tube body ( 3 ) and, when pulled, the section is disposed so as to facilitate the application of force. The section moves relative to the tube body ( 3 ), such that a force application point is adaptively changed. The present invention improves the safety and flexibility of operations when there is a large bending radius, or when using long, hard, or inflexible intervention apparatuses.

First claim

What is claimed is:

1. A bendable delivery system for an implantable valve, comprising:
a bendable sheath, comprising a tube and a pull wire, wherein the tube has a distal end and a proximal end, and the distal end of the tube is configured to be bent by the pull wire, and wherein one end of the pull wire extends towards the proximal end of the tube, a connection portion of the other end of the pull wire and the tube is located at or adjacent to the distal end of the tube, and at least one section of the pull wire is configured as a movable section which is movable outside of the tube; the tube comprises a first section at the distal end for accommodating an implantable instrument, and a connection section connected to the first section and extending towards the proximal end;
a sheath core arranged in the bendable sheath, and an operating handle connected to proximal ends of the bendable sheath and the sheath core; wherein a proximal end of the pull wire is connected with the operating handle;
wherein the sheath core comprises a core tube, and the core tube has a loading section at a distal end for placing the implantable instrument; before release, the first section of the bendable sheath is configured to surround the loading section; and
wherein a distal end of the movable section is configured to enter an inner cavity of the tube from an outer wall of the tube through a first through hole, and then pass out of the tube from the inner cavity through a second through hole, and thereafter being knotted with a portion of the movable section outside the tube.

2. The bendable delivery system for an implantable valve according to claim 1 , wherein the bendable sheath is further provided with a guiding member which functions between the tube and the movable section to delimit a gap between the tube and the movable section when bending.

3. The bendable delivery system for an implantable valve according to claim 2 , wherein a plurality of the guiding members is provided which are spaced-apart from each other in an axial direction of the tube to form a plurality of guiding portions for delimiting the gap between the tube and the movable section.

4. The bendable delivery system for an implantable valve according to claim 2 , wherein the guiding member is configured as a radial expandable structure, and has an undeformed configuration in which the guiding member constrains the movable section against the outer wall of the tube, and a deformed configuration in which the guiding member is locally separated from the tube under an action of the movable section.

5. The bendable delivery system for an implantable valve according to claim 2 , wherein the guiding member is configured as a guiding sleeve that is connected around an outer periphery of the tube and surrounds the movable section.

6. The bendable delivery system for an implantable valve according to claim 5 , wherein the guiding sleeve is configured as a coiled structure, and has a deformed configuration in which the guiding sleeve is locally separated from the tube under an action of the movable section and the corresponding portions of the coiled structure are unfolded, and an undeformed configuration in which the coiled structure automatically returns to drive the movable section to closely contact with the outer wall of the tube.

7. The bendable delivery system for an implantable valve according to claim 6 , wherein the coiled structure in the undeformed configuration is coiled by more than one circle, and a portion extending beyond 360 degrees overlaps with a portion within 360 degrees.

8. The bendable delivery system for an implantable valve according to claim 6 , wherein a starting end and a terminal end of the coiled structure that is coiled in a circumferential direction are connected by a flexible film.

9. The bendable delivery system for an implantable valve according to claim 5 , wherein a distal end and a proximal end of the guiding sleeve are fixed on the outer periphery of the tube, and a section of the guiding sleeve between the distal end and the proximal end is movably arranged around the outer periphery of the tube.

10. The bendable delivery system for an implantable valve according to claim 5 , wherein a distal end of the guiding sleeve is:
fixed on the connection section adjacent to the first section; or
fixed at a junction of the connection section and the first section; or
fixed on the first section and adjacent to a proximal end of the first section.

11. The bendable delivery system for an implantable valve according to claim 5 , wherein a side wall of the guiding sleeve is provided with a reinforced area that contacts and engages with the movable section.

12. The bendable delivery system for an implantable valve according to claim 11 , wherein the reinforced area has a larger thickness relative to the other neighboring area.

13. The bendable delivery system for an implantable valve according to claim 11 , wherein a reinforcement layer is provided in a side wall of the reinforced area.

14. The bendable delivery system for an implantable valve according to claim 1 , wherein the distal end of the movable section is:
fixed on the connection section adjacent to the first section; or
fixed at a junction of the connection section and the first section; or
fixed on the first section.

15. The bendable delivery system for an implantable valve according to claim 14 , wherein the distal end of the movable section is fixed on the first section, and is close to a proximal end of the first section, or is close to a distal end of the first section, or is between the proximal end and the distal end of the first section.

16. The bendable delivery system for an implantable valve according to claim 1 , wherein the pull wire is connected at the distal end of the tube, or less than 5 cm away from the distal end.

17. The bendable delivery system for an implantable valve according to claim 1 , wherein the core tube is fixed with a guiding head at the distal end, and a fixing head for the implantable instrument adjacent to the guiding head, wherein the loading section is between the guiding head and the fixing head for the implantable instrument.

Assignees

• Venus Medtech Hangzhou Inc

Inventors

• Chen Mao
• Feng Yuan
• Zhang Zhifei
• Guo Feng
• Gong Quangang
• Wu Shiguang

Classifications

• A61M25/0147 Primary

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

• A61F2/243

  Deployment by mechanical expansion · CPC title

• A61M25/0023

  by the form of the lumen, e.g. cross-section, variable diameter · CPC title

• A61M25/0136

  Handles therefor · CPC title

• A61M2025/0024

  Expandable catheters or sheaths · CPC title