Introducer sheath having a multi-layer hub

• US 10,709,476 B2
• Filed: 02/22/2017
• Issued: 07/14/2020
• Est. Priority Date: 02/22/2016
• Status: Active Grant

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Murphy, John
• Primary Examiner(s): Plionis, Nicholas J
• Application Number:
  US15/438,917
• Publication Number:
  US 20170238965A1
• Time in Patent Office: 1,238 Days
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/135 inside a blood vessel, e.g. using grafting
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body

Abstract

An introducer assembly includes an elongate sheath sized for insertion into a blood vessel of a patient and a hub. The hub can be coupled to a proximal portion of the sheath and can include a first hub portion and a second hub portion. The hub can include various features to facilitate breaking apart or separating the introducer assembly from a patient. For example, the first hub portion can have a first notch which can facilitate breaking, splitting, or fracturing the hub. The second hub portion can partially surround the first hub portion and can include two wings and an opening disposed above the first notch. The first hub portion can be formed from a first material and second hub portion can be formed from a second material. In some embodiments, the second material can be stiffer than the first material to facilitate fracturing the hub.

Claims

1. An introducer assembly comprising:

an elongate sheath sized for insertion into a blood vessel of a patient, the sheath having a longitudinal axis, wherein the elongate sheath consists of a first material;

a hub coupled to a proximal portion of the sheath, the hub comprising;

a first hub portion having a first notch, the first hub portion partially encompassing the proximal portion of the elongate sheath;

a second hub portion partially encompassing the first hub portion, the second hub portion comprising;

two wings; and

an opening disposed above the first notch; and

wherein the first hub portion consists of the first material and the second hub portion comprises a second material, the first material differing from the second material.

2. The introducer assembly of claim 1, wherein the first material has a first ultimate strength and the second material has a second ultimate strength, the second ultimate strength being greater than the first ultimate strength.

3. The introducer assembly of claim 1, wherein the first material has a first stiffness and the second material has a second stiffness, the second stiffness being greater than the first stiffness.

4. The introducer assembly of claim 1, wherein the first notch is oriented parallel to the longitudinal axis of the elongate sheath.

5. The introducer assembly of claim 1, wherein the hub is configured to break at the first notch along a direction of the longitudinal axis of the elongate sheath.

6. The introducer assembly of claim 1, wherein the elongate sheath further comprises a longitudinal scoring parallel to the longitudinal axis of the elongate sheath.

7. The introducer assembly of claim 6, wherein the elongate sheath is configured to tear along the longitudinal scoring parallel to the longitudinal axis of the elongate sheath.

8. The introducer assembly of claim 1, wherein the first hub portion includes ridges.

9. The introducer assembly of claim 1, wherein the first hub portion and the elongate sheath form a hemostatic bond, wherein the hemostatic bond is configured to prevent blood from flowing between the first hub portion and the elongate sheath.

10. The introducer assembly of claim 1, wherein the wings each comprise a wide face and a narrow face, and the wide face is normal to the longitudinal axis of the elongate sheath.

11. The introducer assembly of claim 1, wherein the wings each comprise a wide face and a narrow face, and the narrow face is normal to the longitudinal axis of the elongate sheath.

12. The introducer assembly of claim 1, wherein the first hub portion includes a first ridge and a second ridge which define edges of the first notch.

13. The introducer assembly of claim 1, wherein the first material has a hardness of about 45 Shore D.

14. The introducer assembly of claim 1, wherein the second material has a hardness in the range of about 68-72 Shore D.

15. The introducer assembly of claim 1, wherein the hub has a minimum diameter of about 9 Fr.

16. The introducer assembly of claim 1, wherein the first hub portion has a minimum thickness of 0.1 mm at the first notch.

17. The introducer assembly of claim 1, wherein the thickness of the first hub portion at the first notch is variable along a length of the notch.

18. The introducer assembly of claim 17, wherein the thickness of the first hub portion at the first notch is greatest at a proximal end portion of the first hub portion.

19. The introducer assembly of claim 18, wherein the thickness of the first hub portion at the first notch is between about 0.01 inches and 0.012 inches at the proximal end portion of the first hub portion.

20. The introducer assembly of claim 18, wherein the thickness of the first hub portion at the first notch is between about 0.004 inches and 0.006 inches at a distal end portion of the first hub portion.