Variable size repositioning sheath

Patent metadata

Field	Value
Publication number	US-11911072-B2
Application number	US-202016854357-A
Country	US
Kind code	B2
Filing date	Apr 21, 2020
Priority date	Apr 22, 2019
Publication date	Feb 27, 2024
Grant date	Feb 27, 2024

Abstract

Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

First claim

The invention claimed is:

1. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising:
an introducer sheath, wherein the introducer sheath is connected to an introducer sheath hub; and
a variable size repositioning sheath configured to be inserted into a blood vessel and to be adjustable in size in a radial direction, wherein the variable size repositioning sheath is connected to a repositioning sheath hub forming a sizing device, the sizing device configured to adjust the variable size repositioning sheath in a radial direction;
wherein the repositioning sheath hub is attached to the introducer sheath hub.

2. The sheath assembly of claim 1 , wherein the variable size repositioning sheath is configured to be adjustable to a radial size that is up to 2 Fr smaller than a radial size of the introducer sheath.

3. The sheath assembly of claim 1 , wherein the variable size repositioning sheath comprises:
an outer repositioning sheath component; and
an inner repositioning sheath component disposed at least partially within the outer repositioning sheath component, and
wherein the variable size repositioning sheath is further configured to change in size in a radial direction based on the inner repositioning sheath component moving translationally or rotationally relative to the outer repositioning sheath component.

4. The sheath assembly of claim 1 , wherein the variable size repositioning sheath further comprises a ratchet-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be adjustable in size in a radial direction using the ratchet-type inner repositioning sheath component.

5. The sheath assembly of claim 1 , wherein the variable size repositioning sheath further comprises a cam-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the cam-type inner repositioning sheath component.

6. The sheath assembly of claim 1 , wherein the variable size repositioning sheath further comprises mandrel-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the mandrel-type inner repositioning sheath component.

7. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising:
an expandable introducer sheath; and
a variable size repositioning sheath having a sheath body that is configured to be inserted into the expandable introducer sheath and to be adjustable in size in a radial direction along the full length of the sheath body.

8. The sheath assembly of claim 7 , wherein the variable size repositioning sheath comprises:
an outer repositioning sheath component; and
an inner repositioning sheath component disposed at least partially within the outer repositioning sheath component, and
wherein the variable size repositioning sheath is further configured to change in size in a radial direction based on the inner repositioning sheath component moving translationally or rotationally relative to the outer repositioning sheath component.

9. The sheath assembly of claim 7 , wherein the variable size repositioning sheath further comprises a ratchet-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be adjustable in size in a radial direction using the ratchet-type inner repositioning sheath component.

10. The sheath assembly of claim 7 , wherein the variable size repositioning sheath further comprises a cam-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the cam-type inner repositioning sheath component.

11. The sheath assembly of claim 7 , wherein the variable size repositioning sheath further comprises mandrel-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the mandrel-type inner repositioning sheath component.

12. A blood pump system, comprising:
an intracardiac device comprising a pump and a cannula, the pump having a pump housing, a rotor, and an opening in the pump housing, the cannula having a proximal end that interfaces with a distal end of the pump housing and a distal end with at least one distal opening, the pump being configured to be operated by a motor;
an elongate catheter coupled on its distal end to the motor or to the pump housing; and
a sheath assembly, comprising:
an introducer sheath configured to introduce the intracardiac device into a blood vessel; and
a variable size repositioning sheath having a sheath body that is adjustable in a radial direction along the full length of the sheath body, the variable size repositioning sheath configured to reposition the intracardiac device inside the blood vessel.

13. The blood pump system of claim 12 , wherein the variable size repositioning sheath is configured to be adjustable to a radial size that is up to 2 Fr smaller than a radial size of the introducer sheath.

14. The blood pump system of claim 12 , wherein the repositioning sheath comprises:
an outer repositioning sheath component; and
an inner repositioning sheath component disposed at least partially within the outer repositioning sheath component, and
wherein the variable size repositioning sheath is further configured to change in size in a radial direction based on the inner repositioning sheath component moving translationally or rotationally relative to the outer repositioning sheath component.

15. The blood pump system of claim 12 , wherein the variable size repositioning sheath further comprises a ratchet-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be adjustable in size in a radial direction using the ratchet-type inner repositioning sheath component.

16. The blood pump system of claim 12 , wherein the variable size repositioning sheath further comprises a cam-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the cam-type inner repositioning sheath component.

17. The blood pump system of claim 12 , wherein the variable size repositioning sheath further comprises mandrel-type inner repositioning sheath component, and the variable size repositioning sheath is configured to be sized in the radial direction using the mandrel-type inner repositioning sheath component.

18. A sheath assembly for the insertion of a medical device into a blood vessel, the sheath assembly comprising:
a peel-away introducer sheath having a sheath body with a fixed outer diameter; and
a variable size repositioning sheath having a sheath body that is configured to be adjustable in size in a radial direction between at least a first state and a second state along the full length of the sheath body,
wherein when the variable size repositioning sheath is in the first state, an outer diameter of the variable size repositioning sheath is larger than the fixed outer diameter, and
wherein when the variable size repositioning sheath is in the second state, the outer diameter of the variable size repositioning sheath is smaller than the fixed outer diameter.

19. The sheath assembly of claim 18 , wherein the variable size repositioning sheath comprises:
an outer repositioning sheath component; and
an inner repositioning sheath component disposed

Assignees

• Abiomed Inc

Inventors

• Fantuzzi Glen
• Korkuch Christopher
• Hastie Caitlyn
• Fishman Robert
• Ashok Akshay
• Modlish John

Classifications

• A61M60/13

  by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system · CPC title

• A61B17/3439 Primary

  with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662) · CPC title

• A61B17/3468 Primary

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61M60/148

  in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices · CPC title

• A61M60/174

  discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system · CPC title