KR-102960293-B1 - Variable size relocation system

KR102960293B1KR 102960293 B1KR102960293 B1KR 102960293B1KR-102960293-B1

Abstract

A system and method for inserting a medical device into a blood vessel are provided. The system may include a sheath assembly having an insertion sheath (120, 220) and a variable-size repositioning sheath (110). The variable-size repositioning sheath (110) may be radially resizable and configured to be inserted into a blood vessel (142) or an expandable insertion sheath (220). In some embodiments, the system may include an intracardiac device (130), such as a blood pump (137) having an elongated catheter (132).

Inventors

판투지 글렌
코쿠치 크리스토퍼
해스티 차이틀린
피시맨 로버트
애쇽 액샤이
모드리시 존

Assignees

아비오메드, 인크.

Dates

Publication Date: 20260508
Application Date: 20200421
Priority Date: 20190422

Claims (20)

In a sheath assembly for inserting a medical device into a blood vessel, the sheath assembly comprises: An introductory system having an introductory system hub; and Variable-size repositioning sheath configured to be inserted into blood vessels and radially resized Includes, The variable-size repositioning sheath is connected to a repositioning sheath hub to form a sizing device, and the sizing device is configured to adjust the variable-size repositioning sheath radially; The above relocation sys hub is configured to be lockably coupled to the above introductory sys hub. A sheath assembly characterized by
A sheath assembly according to claim 1, characterized in that the variable-size repositioning sheath is configured to be adjustable to a radial size up to 2Fr smaller than the radial size of the introductory sheath.
In paragraph 1, the variable-size repositioning sheath is: External relocation sys elements; and It includes an internal relocation sheath element positioned at least partially within the above external relocation sheath element, and A sheath assembly characterized by the above variable-size repositioning sheath being further configured to change size radially based on an internal repositioning sheath element that translates or rotates relative to an external repositioning sheath element.
A sheath assembly according to claim 1, wherein the variable size repositioning sheath further includes a ratchet-type internal repositioning sheath element, and the variable size repositioning sheath is configured to be radially sized using the ratchet-type internal repositioning sheath element.
A sheath assembly according to claim 1, characterized in that the variable size repositioning sheath further includes a cam-type internal repositioning sheath element, and the variable size repositioning sheath is configured to have its size determined radially using the cam-type internal repositioning sheath element.
A sheath assembly according to claim 1, wherein the variable size repositioning sheath further comprises a mandrel-shaped internal repositioning sheath element, and the variable size repositioning sheath is configured such that its size is determined in the radial direction using the mandrel-shaped internal repositioning sheath element.
In a sheath assembly for inserting a medical device into a blood vessel, the sheath assembly comprises: Scalability introduction phase system; and A sheath assembly characterized by including a variable-size repositioning sheath having a sheath body that is inserted into the above-mentioned expandable sheath and configured to be radially adjustable in size along the entire length of the sheath body.
In paragraph 7, the variable-size relocation sheath is: External relocation sys elements; and An internal relocation sheath element positioned at least partially within the above external relocation sheath element Includes, The above variable-size repositioning sheath is additionally configured to change size radially based on an internal repositioning sheath element that translates or rotates relative to an external repositioning sheath element. A sheath assembly characterized by
A sheath assembly according to claim 7, wherein the variable size repositioning sheath further comprises a ratchet-type internal repositioning sheath element, and the variable size repositioning sheath is configured to be radially sized using the ratchet-type internal repositioning sheath element.
A sheath assembly according to claim 7, wherein the variable size repositioning sheath further includes a cam-type internal repositioning sheath element, and the variable size repositioning sheath is configured such that its size is determined in the radial direction using the cam-type internal repositioning sheath element.
A sheath assembly according to claim 7, wherein the variable-size repositioning sheath further comprises a mandrel-shaped internal repositioning sheath element, and the variable-size repositioning sheath is configured such that its size is determined in the radial direction using the mandrel-shaped internal repositioning sheath element.
In a blood pump system, the blood pump system is: An intracardiac device comprising a pump having a pump housing, a rotor, and an opening in the pump housing, and a cannula having a proximal end interfacing with a distal end of the pump housing and a distal end having at least one distal opening—the pump is configured to be operated by a motor—; An elongated catheter coupled to a motor or pump housing at the distal end; and Sheath assembly Includes, The above sheath assembly is: An introducer sheath configured to introduce an intravascular device; and A variable-size repositioning sheath having a sheath body that is radially adjustable along the entire length of the sheath body - said variable-size repositioning sheath is configured to reposition said intracardiac device within a blood vessel -; A blood pump system characterized by including
A blood pump system according to claim 12, characterized in that the variable-size repositioning sheath is configured to be adjustable to a radial size up to 2 Fr smaller than the radial size of the introductory sheath.
In Clause 12, the above relocation sheath is: External relocation sys elements; and An internal relocation sheath element positioned at least partially within the above external relocation sheath element Includes, A blood pump system characterized in that the variable-size repositioning sheath is further configured to change in size radially based on the internal repositioning sheath element that translates or rotates relative to the external repositioning sheath element.
A blood pump system according to claim 12, wherein the variable size repositioning sheath further comprises a ratchet-type internal repositioning sheath element, and the variable size repositioning sheath is configured to be radially sized using the ratchet-type internal repositioning sheath element.
A blood pump system according to claim 12, wherein the variable size repositioning sheath further comprises a cam-type internal repositioning sheath element, and the variable size repositioning sheath is configured such that its size is determined radially using the cam-type internal repositioning sheath element.
A blood pump system according to claim 12, wherein the variable-size repositioning sheath further comprises a mandrel-type internal repositioning sheath element, and the variable-size repositioning sheath is configured such that its size is determined radially using the mandrel-type internal repositioning sheath element.
In a sheath assembly for inserting a medical device into a blood vessel, the sheath assembly comprises: A peel-away introductory sheath having a sheath body having a fixed outer diameter; and A variable-size repositioning sheath having a sheath body configured to be radially adjustable between at least a first state and a second state along the entire length of the sheath body. Includes, When the variable-size repositioning sheath is in the first state, the outer diameter of the variable-size repositioning sheath is larger than the fixed outer diameter, and 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. A sheath assembly characterized by
In paragraph 18, the above variable-size relocation sheath is: External relocation sys elements; and It includes an internal relocation sheath element positioned at least partially within the above external relocation sheath element, and A sheath assembly characterized in that the variable-size repositioning sheath is further configured to change size radially based on the internal repositioning sheath element that translates or rotates relative to the external repositioning sheath element.
A sheath assembly according to claim 18, wherein the variable size repositioning sheath further comprises a ratchet-type internal repositioning sheath element, and the variable size repositioning sheath is configured to be radially sized using the ratchet-type internal repositioning sheath element.

Description

Variable size relocation system This application claims priority to US provisional application 62/836,960, filed on April 22, 2019, which is incorporated herein by reference. An intracardiac pump assembly can be introduced surgically or transcutaneously and used to deliver blood to or from one location in the cardiovascular system or another location in the cardiovascular system. For example, when placed in the heart, the intracardiac pump can pump blood from the left ventricle of the heart into the aorta or from the right ventricle into the pulmonary artery. Intracardiac pumps can be driven by a motor located outside the patient's body or by a motor located inside the patient's body. Some intracardiac blood pump systems operate in parallel with the primary heart to supplement cardiac output and can partially or completely eliminate cardiac components. Examples of such systems include the IMPELLA® device family (Abiomed, Inc., Danvers, MA). FIG. 1 illustrates a placement system comprising a fill-away introducer sheath configured to introduce an intracardiac device into a patient's vascular structure according to an embodiment of the present invention, and a variable-size repositioning sheath radially sized for insertion into an arteriotomy after removal of the fill-away introducer; FIG. 2 illustrates a placement system according to an embodiment of the present invention, comprising an expandable introducer sheath configured to introduce an intracardiac device into a patient's vascular structure, and a radially sized variable-size repositioning sheath for insertion into the expandable introducer sheath; FIG. 3A is a cross-sectional view of an exemplary sizing device according to an embodiment of the present invention; FIG. 3B is a drawing illustrating a method in which relative movement between internal and external elements of an exemplary sizing device can produce expansion or contraction according to an embodiment of the present invention; FIG. 3C is a partial cross-sectional view of an exemplary sizing device according to an embodiment of the present invention; FIG. 4A is a cross-sectional view of an exemplary sizing device according to an embodiment of the present invention; FIG. 4B is a cross-sectional view of an exemplary internal repositioning sheath element according to some aspects of the present invention; FIG. 4C is a cross-sectional view of an exemplary internal repositioning sheath element according to some aspect of the present invention; FIG. 4D is a cross-sectional view of an exemplary internal repositioning sheath element according to some aspect of the present invention; FIG. 4E is a cross-sectional view of an exemplary internal repositioning sheath element according to some aspects of the present invention; FIG. 4F is a cross-section of an exemplary stepped structure configured to be placed in a variable-size repositioning sheath hub according to an embodiment of the present invention; FIG. 5 is a placement system according to an embodiment of the present invention, comprising a variable-size repositioning sheath inserted into an arterial incision after an intracardiac device is inserted through an introductory sheath; and FIG. 6 is a placement system according to an embodiment of the present invention, comprising a variable-size repositioning sheath inserted into an arterial incision after an intracardiac device is inserted through an introductory sheath. To provide an overall understanding of the systems, methods, and devices described herein, specific illustrated examples are described. While the examples and features described herein are specifically described for use in relation to intracardiac heart pump systems, it will be understood that all elements and other features described below can be combined with one another in any appropriate manner and can be adapted and applied to other types of medical devices such as electrophysiological studies and catheter ablation devices, angioplasty and stent insertion devices, angiographic catheters, peripherally inserted central catheters, central venous catheters, midline catheters, peripheral catheters, inferior vena cava filters, abdominal aortic aneurysm treatment devices, thrombectomy devices, TAVR delivery systems, cardiac therapy and cardiac assist devices (including balloon pumps), cardiac assist devices implanted using surgical incisions, and other venous or artery-based introduction catheters and devices. The system and method described herein provide a sheath assembly for inserting a medical device (e.g., an intracardiac heart pump) into a blood vessel through a blood vessel opening. The sheath assembly may include an insertion sheath and a variable-size repositioning sheath. The insertion sheath may include a fill-away insertion sheath or an inflatable insertion sheath. The variable-size repositioning sheath may be radially sized so that its diameter can be adjusted over a specific range. In some embodiments, the adjustment range o