US-12616502-B2 - Introducer sheath with dual arm hub having inbuilt tightening port

US12616502B2US 12616502 B2US12616502 B2US 12616502B2US-12616502-B2

Abstract

An introducer sheath including a valve hub and an elongate shaft extending from the valve hub. The valve hub defines a main port and a side port. The main port includes a hub body, a compressible seal disposed within the hub body, a pusher at least partially positioned within the hub body and slidably movable relative thereto, and a lock nut surrounding the pusher. The lock nut is threadably engaged with the hub body such that rotation of the lock nut moves the pusher axially toward and/or away from the compressible seal.

Inventors

Neeraj Kumar Sharma
Qian Liu
Boney Augustine

Assignees

Boston Scientific Medical Device Limited
BOSTON SCIENTIFIC SCIMED, INC.

Dates

Publication Date: 20260505
Application Date: 20240509

Claims (14)

1 . An introducer sheath, comprising: a valve hub defining a main port and a side port; and an elongate shaft extending from the valve hub; wherein the main port includes: a hub body; a compressible seal disposed within the hub body; a pusher at least partially positioned within the hub body and slidably movable relative thereto; and a lock nut surrounding the pusher, the lock nut threadably engaged with the hub body such that rotation of the lock nut moves the pusher axially toward and/or away from the compressible seal; wherein the pusher includes first and second tabs extending radially from a body of the pusher, the first and second tabs of the pusher are positioned in first and second slots in the hub body, respectively; and a holder including first and second tabs extending radially from a body of the holder, wherein the first and second tabs of the holder are positioned in the first and second slots in the hub body, respectively.
2 . The introducer sheath of claim 1 , wherein the first and second tabs of the pusher extend in opposite directions.
3 . The introducer sheath of claim 1 , wherein an internal rim of the lock nut engages the first and second tabs of the pusher.
4 . The introducer sheath of claim 1 , further comprising a first O-ring surrounding a distal portion of the pusher and a second O-ring surrounding a proximal portion of the pusher.
5 . The introducer sheath of claim 4 , wherein the first and second tabs are located between the first O-ring and the second O-ring.
6 . The introducer sheath of claim 1 , wherein the pusher extends proximal of the hub body.
7 . The introducer sheath of claim 1 , wherein the main port includes an elastomeric seal, wherein the pusher is positioned between the compressible seal and the elastomeric seal.
8 . The introducer sheath of claim 1 , wherein the side port includes an elastomeric seal including one or more slits formed therein.
9 . An introducer sheath, comprising: a valve hub defining a main port and a side port; and an elongate shaft extending from the valve hub; wherein the main port includes: a hub body: a compressible seal disposed within the hub body: an elastomeric seal proximal of and spaced apart from the compressible seal; a lock nut threadably engaged with the hub body such that rotation of the lock nut moves the compressible seal between an opening position and a closed position; a pusher engaged with the lock nut, such that rotation of the lock nut causes the pusher to axially move toward and/or away from the compressible seal; wherein the pusher includes first and second tabs extending radially from a body of the pusher, the first and second tabs of the pusher are positioned in first and second slots in the hub body, respectively; wherein an internal rim of the lock nut engages the first and second tabs; and a holder including first and second tabs extending radially from a body of the holder, wherein the first and second tabs of the holder are positioned in the first and second slots in the hub body, respectively.
10 . The introducer sheath of claim 9 , wherein: the first tab of the pusher is positioned between an end surface of the first slot and the first tab of the holder; the second tab of the pusher is positioned between an end surface of the second slot and the second tab of the holder; and the first and second tabs of the pusher are axially movable in the first and second slots, respectively.
11 . An introducer sheath, comprising: a valve hub defining a main port and a side port; and an elongate shaft extending from the valve hub; wherein the main port includes: a hub body; a compressible seal disposed within the hub body; a pusher having a distal surface juxtaposed with a proximal surface of the compressible seal; and a holder coupled to the valve hub; wherein a distal end region of the pusher extends into the hub body and is slidably movable relative thereto; and wherein a proximal end region of the pusher extends into the holder and is slidably movable relative thereto; wherein the pusher includes first and second tabs extending radially from a body of the pusher, the first and second tabs of the pusher are positioned in first and second slots in the hub body, respectively, and the first and second tabs of the pusher are axially movable in the first and second slots, respectively.
12 . The introducer sheath of claim 11 , further comprising a lock nut surrounding the pusher, the lock nut threadably engaged with the hub body such that rotation of the lock nut moves the pusher axially toward and/or away from the compressible seal.
13 . The introducer sheath of claim 11 , further comprising a first O-ring surrounding the distal end region of the pusher and a second O-ring surrounding the proximal end region of the pusher.
14 . The introducer sheath of claim 11 , wherein the holder includes first and second tabs extending radially from a body of the holder, wherein the first and second tabs of the holder are positioned in the first and second slots in the hub body, respectively.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/465,958, filed May 12, 2023, which is incorporated herein by reference. TECHNICAL FIELD The present disclosure pertains to sheaths for delivering intravascular medical devices. More specifically, the present disclosure relates to a hub of a sheath with a tightening port for securing a medical device, such as a catheter or blood pump, within the hub and thus fix the position of the catheter with respect to the hub and sheath. BACKGROUND In various procedures for delivering intravascular medical devices, a sheath is inserted into a blood vessel of a patient, for example a femoral artery, and one or more medical devices may be advanced through the sheath and into the patient's vasculature. In various instances, the medical devices include catheters or other devices, such as a blood pump. A hub may be incorporated at a proximal end of the sheath to provide access to a lumen of an elongate shaft of the sheath. The hub may include one or more seals, e.g., hemostasis seals, to reduce blood leakage as devices are being inserted, positioned, and removed. In various instances, there may be a desire to fix the position of the medical device within the sheath and vasculature. Additionally, there may be a desire to reposition the medical device within the vasculature. Thus, there is a need for improved hub configurations for a sheath including sealing mechanisms to reduce blood leakage past the medical device and/or tightening mechanisms for securing the medical device, such as a catheter or blood pump, within the sheath and vasculature that also allow repositioning of the medical device in the vasculature. BRIEF SUMMARY This disclosure provides design, material, manufacturing method, and use alternatives for medical devices, including introducer and/or repositioning sheaths. A first example is directed to an introducer sheath including a valve hub and an elongate shaft extending from the valve hub. The valve hub defines a main port and a side port. The main port includes a hub body, a compressible seal disposed within the hub body, a pusher at least partially positioned within the hub body and slidably movable relative thereto, and a lock nut surrounding the pusher. The lock nut is threadably engaged with the hub body such that rotation of the lock nut moves the pusher axially toward and/or away from the compressible seal. Alternatively or additionally to any of the examples above, in another example, the pusher includes first and second tabs extending radially from a body of the pusher. Alternatively or additionally to any of the examples above, in another example, the first and second tabs are positioned in first and second slots in the hub body, respectively. Alternatively or additionally to any of the examples above, in another example, the first and second tabs extend in opposite directions. Alternatively or additionally to any of the examples above, in another example, an internal rim of the lock nut engages the first and second tabs. Alternatively or additionally to any of the examples above, in another example, the introducer sheath further includes a first O-ring surrounding a distal portion of the pusher and a second O-ring surrounding a proximal portion of the pusher. Alternatively or additionally to any of the examples above, in another example, the first and second tabs are located between the first O-ring and the second O-ring. Alternatively or additionally to any of the examples above, in another example, the pusher extends proximal of the hub body. Alternatively or additionally to any of the examples above, in another example, the main port includes an elastomeric seal, wherein the pusher is positioned between the compressible seal and the elastomeric seal. Alternatively or additionally to any of the examples above, in another example, the elastomeric seal includes one or more slits. Alternatively or additionally to any of the examples above, in another example, the side port includes an elastomeric seal including one or more slits formed therein. Another example is an introducer sheath. The introducer sheath includes a valve hub defining a main port and a side port, and an elongate shaft extending from the valve hub. The main port includes a hub body, a compressible seal disposed within the hub body, an elastomeric seal proximal of and spaced apart from the compressible seal, and a lock nut threadably engaged with the hub body such that rotation of the lock nut moves the compressible seal between an opening position and a closed position. Alternatively or additionally to any of the examples above, in another example, the introducer sheath includes a pusher engaged with the lock nut, such that rotation of the lock nut causes the pusher to axially move toward and/or away from the compressible seal. Alternatively or additionally to any of the examples above, in another example, th