Medical device control handle with integrated flush port/seal features

Patent metadata

Field	Value
Publication number	US-2024285906-A1
Application number	US-202418411803-A
Country	US
Kind code	A1
Filing date	Jan 12, 2024
Priority date	Jan 13, 2023
Publication date	Aug 29, 2024
Grant date	—

Abstract

Described are systems for hand-held control of medical device structures. The systems can include a control handle including a handle housing and an actuator movably mounted to the handle and attached to a control shaft. A sheath is attached to a distal end of the handle housing and has a lumen fluidly communicating with a distal opening of the sheath. The control shaft extends from the handle housing and into the lumen of the sheath. A medical device structure is attached to the control shaft and the actuator is operable by the hand of the user to cause movement of the control shaft distally relative to the handle housing, for example so as to deploy the medical device structure from the distal opening of the sheath, and proximally relative to the handle housing, for example so as to retract the medical device structure into the distal opening of the sheath. A seal element is mounted in the handle housing and the control shaft extends through the seal element. The seal element is cooperable with the control shaft to maintain a seal against the control shaft during the movement of the control shaft. A flush port is provided which fluidly communicates with the lumen of the sheath and can also fluidly communicate with a surface of the seal element. Handles useful in such systems, as well as related methods of manufacture and use, are also described.

First claim

1 . A system for hand-held control of a medical device structure, comprising:
a control handle including a handle housing and an actuator movably mounted to the handle housing and arranged for manual operation by a hand of a user; a control shaft connected to the actuator; a sheath attached to a distal end of the handle housing and having a lumen extending to a distal opening of the sheath, with the control shaft extending from the handle housing and into the lumen of the sheath; a medical device structure attached to the control shaft, with the actuator being operable by the hand of the user to cause movement of the control shaft distally relative to the handle housing so as to deploy the medical device structure from the distal opening of the sheath and proximally relative to the handle housing so as to retract the medical device structure into the distal opening of the sheath; a seal element mounted in the handle housing, with the control shaft extending through the seal element, wherein the seal element is cooperable with the control shaft to maintain a seal against the control shaft during said movement of the control shaft; and a flush port opening in fluid communication with the lumen of the sheath, optionally wherein the flush port opening is on the control handle.

2 . The system of claim 1 , wherein the seal element sealingly interrupts a fluid passage extending from the distal opening of the sheath, through the lumen of the sheath and into an interior space of the handle housing.

3 . The system of claim 1 , wherein the seal element comprises at least a first opening therein, with said control shaft received through said first opening and being longitudinally slidable and rotatable relative to said first opening.

4 . The system of claim 3 , wherein the seal element comprises at least a first elastomeric disc.

5 . The system of claim 1 , comprising at least one of, or both of:
a. a seal assembly mounted within the handle housing, the seal assembly including the seal element received against a seal body portion defining a first lumen, the seal assembly optionally also including a seal cap attached to the seal body portion and pressing the seal element against the seal body portion; and b. a flush port assembly mounted within the handle housing, the flush port assembly including a flush port body including a first flush port body portion defining a first flush lumen portion and a second flush port body portion extending transversely to the first flush port body portion and defining a second flush lumen portion extending from the flush port opening and intersecting and fluidly communicating with the first flush lumen portion, wherein the second flush port body portion provides a flush port stem.

6 . The system of claim 5 , wherein:
a. the handle housing has one or more inwardly-directed walls that contact and positionally fix the seal assembly relative to the handle housing, optionally wherein the one or more inwardly-directed walls contact and positionally fix the seal assembly against distal, proximal, lateral and rotational movement relative to the handle housing;
and/or
b. the handle housing has one or more inwardly-directed walls that contact and positionally fix the flush port assembly relative to the handle housing, optionally wherein the one or more inwardly-directed walls contact and positionally fix the flush port assembly against distal, proximal, lateral and rotational movement relative to the handle housing.

7 - 8 . (canceled)

9 . The system of claim 5 , comprising both the seal assembly and the flush port assembly.

10 . The system of claim 9 , wherein the flush port assembly and the seal assembly are subcomponents of a flush port/seal assembly.

11 . The system of claim 10 , wherein the seal body portion and the flush port body are segments of an integral flush port/seal body.

12 . The system of claim 10 , wherein the handle housing has one or more inwardly-directed walls that contact and positionally fix the flush port/seal assembly relative to the handle housing, optionally wherein the one or more inwardly-directed walls contact and positionally fix the flush port/seal assembly against distal, proximal, lateral and rotational movement relative to the handle housing.

13 . The system of claim 12 , wherein the handle housing is composed of at least a first handle housing portion and a second handle housing portion connected together, wherein the first handle housing portion includes a first inwardly-directed wall portion and the second handle housing portion includes a second inwardly-directed wall portion, and wherein the first and second inwardly-directed wall portions align with one another and have respective inward end surfaces that contact and cradle an exterior surface of the flush port/seal assembly.

14 - 21 . (canceled)

22 . The system of claim 1 , wherein the actuator is also rotatable by the hand of the user to cause rotation of the control shaft relative to the handle housing so as to rotate the medical device structure.

23 - 25 . (canceled)

26 . The system of claim 1 , wherein the medical device structure is a vascular snare element.

27 - 34 . (canceled)

35 . A method for preparing a system prior to use on a patient, comprising:
providing a system according to claim 1 ; and passing a flush liquid into the flush port opening, through the lumen of the sheath, and out the distal opening of the sheath.

36 . A method for treating a patient using a medical device, comprising:
providing a system according to claim 1 ; passing a flush liquid into the flush port, through the lumen of the sheath, and out the distal opening of the sheath; after said passing a flush liquid, introducing the sheath into a vascular vessel of the patient; operating the actuator by hand to cause movement of the control shaft distally relative to the handle housing so as to deploy the medical device structure from the distal opening of the sheath; and treating the patient with the medical device structure.

37 . The method of claim 36 , wherein the medical device structure is a vascular snare element, and wherein the treating comprises securing and removing an implant from the vascular vessel with the vascular snare element.

38 - 39 . (canceled)

40 . A medical device control handle for hand-held control of a medical device structure that is connected to a control shaft and deployable from a lumen of a sheath, the medical device control handle comprising:
a handle housing; an actuator movable relative to the handle housing and arranged for manual operation by a hand of a user, the actuator being connectable to the control shaft; and at least one of, or both of: a. a seal assembly mounted in the handle housing and configured to maintain a seal against an outer surface of a control shaft for a medical device, the seal assembly including a seal body defining a lumen therein and a seal element received against the seal body; and b. a flush port assembly mounted in the handle housing, the flush port assembly including a flush port body having a first flush port body portion defining a first flush lumen portion therein configured to fluidly communicate with a sheath lumen and a second flush port body portion extending transverse to the first flush port body portion and providing a flush port stem defining a second flush lumen portion therein and extending to a flush port opening, the second flush lumen portion intersecting and fluidly co

Assignees

• Cook Medical Technologies Llc

Inventors

• Hansen Palle Munk

Classifications

• A61B2217/007

  with irrigation system · CPC title

• A61B2017/0046

  with a releasable handle; with handle and operating part separable · CPC title

• A61B17/00 Primary

  Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20) · CPC title

• A61M2039/0018

  designed for flushing a line, e.g. by a by-pass · CPC title

• A61M39/00

  Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use (for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24) · CPC title