US-12616826-B2 - Push-pull tightening port for percutaneous circulatory support device repositioning and axial locking, and attachment to sheath hub

US12616826B2US 12616826 B2US12616826 B2US 12616826B2US-12616826-B2

Abstract

A tightening port for use with a hemostasis valve of an introducer sheath includes a gripper configured for engagement with the hemostasis valve hub, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end, a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper, and wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter.

Inventors

Neeraj Kumar Sharma
Sumit Agrawal
Rupesh Kumar Pahwa
Qian Liu

Assignees

Boston Scientific Medical Device Limited
BOSTON SCIENTIFIC SCIMED INC.

Dates

Publication Date: 20260505
Application Date: 20230302

Claims (13)

1 . A tightening port for use with a hemostasis valve hub of a sheath, the tightening port comprising: a gripper configured for engagement with the hemostasis valve hub, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end; and a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and the base has a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper; wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter, wherein the gripper comprises one or more posts configured for engaging with the hemostasis valve hub; and wherein the plurality of engagement features comprises at least four protrusions that extend radially inward from an outer circumference of the base.
2 . The tightening port of claim 1 , wherein the one or more posts comprises a plurality of posts configured for engaging with the hemostasis valve hub.
3 . The tightening port of claim 1 , wherein the plurality of protrusions of the gripper comprises at least four protrusions extending from the cylindrical body.
4 . The tightening port of claim 1 , wherein the base has an outer surface with a plurality of ribs extending circumferentially around the outer surface.
5 . The tightening port of claim 1 , wherein each of the protrusions comprises a detent configured for receiving a portion of the protrusions of the gripper for engagement with the gripper.
6 . The tightening port of claim 1 , wherein the initial diameter has a value of approximately 3.3 mm.
7 . The tightening port of claim 1 , wherein the compressed diameter has a value of approximately 2.8 mm.
8 . The tightening port of claim 1 , wherein the base comprises an extension configured for receiving a sleeve holder.
9 . A tightening port for use with a hemostasis valve hub of a sheath, the tightening port comprising: a gripper configured for engagement with the hemostasis valve hub, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end, wherein the plurality of protrusions of the gripper comprises at least four protrusions extending from the cylindrical body; and a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and the base has a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper; wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter, wherein the gripper comprises one or more posts configured for engaging with the hemostasis valve hub; and wherein each of the protrusions of the gripper has a block extending radially outward from the protrusion.
10 . A delivery system for introducing at least one medical device into a blood vessel, the delivery system comprising: a sheath configured for insertion into the blood vessel, the sheath having a proximal end and a distal end; a hemostasis valve hub having a proximal end and a distal end and the distal end configured for attachment with the proximal end of the sheath; and a tightening port configured for attachment with the proximal end of the hemostasis valve hub, the tightening port comprising: a gripper configured for engagement with the hemostasis valve, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end; and a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and the base has a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper; and wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter; wherein the gripper comprises a plurality of posts configured for engaging with the hemostasis valve hub; and wherein the plurality of engagement features of the base comprises a plurality of protrusions extending radially inwardly from an outer circumference of the base.
11 . The delivery system of claim 10 , wherein the tightening port further comprises the base having an extension and a sleeve holder engaged with the extension of the base.
12 . The delivery system of claim 10 , wherein each of the plurality of engagement features comprises a detent for receiving a portion of the each of the plurality of protrusions of the gripper.
13 . The delivery system of claim 10 , wherein each of the plurality of protrusions includes a block extending radially outward from the protrusion and is received within each of the detents of the base.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to U.S. Provisional Application No. 63/316,221, filed Mar. 3, 2022, which is herein incorporated by reference in its entirety. TECHNICAL FIELD The present disclosure relates to a locking attachment to a hub of an introducer sheath. More specifically, the present disclosure relates to a push-pull tightening port attachment that allows for repositioning and axial locking of a medical device positioned within a hub of the introducer sheath. BACKGROUND In various procedures for delivering intravascular medical devices, an introducer sheath is inserted into a blood vessel of a patient, for example a femoral artery, and medical devices are inserted into the introducer sheath for introduction into the blood vessel. In various instances, the medical devices include catheters or other medical devices such as a blood pump. A hub, for example a hemostasis valve hub, may be incorporated at a proximal end of the introducer sheath to reduce blood leakage as devices are being inserted, positioned, and removed. In various instances, there may be a desire for repositioning of the medical device and stabilization of the medical device upon repositioning. There is a need for increased axial stabilization of the medical devices inserted into the hemostasis valve hub and the introducer sheath while still facilitating passage of the devices through the introducer sheath and allowing for repositioning of the devices. SUMMARY In Example 1, a tightening port for use with a hub of a sheath includes a gripper configured for engagement with the hub of the sheath, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end, a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper, and wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter. In Example 2, the tightening port of Example 1 further includes wherein the hub includes a hemostasis valve hub and the gripper comprises a plurality of posts configured for engaging with the hub. In Example 3, the tightening port of Example 1 or Example 2 further includes wherein the plurality of protrusions of the gripper includes at least four protrusions extending from the cylindrical body. In Example 4, the tightening port of Example 3 further includes wherein each of the protrusions of the gripper has a block extending radially outward form the protrusion. In Example 5, the tightening port of any one of Examples 1-4 further includes wherein the base has an outer surface with a plurality of ribs extending circumferentially around the outer surface. In Example 6, the tightening port of any one of Examples 1-5 further includes wherein the plurality of engagement features comprises at least four protrusions that extend radially inward from an outer circumference of the base. In Example 7, the tightening port of Example 6 further includes wherein each of the protrusions includes a detent configured for receiving a portion of the protrusions of the gripper for engagement with the gripper. In Example 8, the tightening port of any one of Examples 1-7 further includes wherein the base includes an extension configured for receiving a sleeve holder. In Example 9, delivery system for introducing at least one medical device into a blood vessel includes a sheath configured for insertion into the blood vessel, the sheath having a proximal end and a distal end, a valve hub having a proximal end and a distal end and the distal end configured for attachment with the proximal end of the sheath, and a tightening port configured for attachment with the proximal end of the valve hub. The tightening port includes a gripper configured for engagement with the hemostasis valve, the gripper having a proximal end, a distal end, a cylindrical body defining a lumen, and a plurality of protrusions extending from the proximal end, a base having a cylindrical body and a lumen defined therethrough for receiving a portion of the gripper, and a plurality of engagement features configured for engaging with the plurality of protrusions of the gripper, wherein the lumen of the gripper has an initial diameter prior to engagement with the base, and the lumen of the gripper has a compressed diameter after engagement with the base, wherein the compressed diameter is less than the initial diameter. In Example 10, the delivery system of Example 9 further includes wherein the tightening port further includes a sleeve holder engaged with an extension of the base. In Example 11, the delivery system of Example 9 or Example 10 further includ