CN-119894467-B - Systems and methods for customizable shunt implants

Abstract

Neurovascular shunts and delivery systems and methods of using the same are described herein. The system may include a customization member including an introducer sheath, a catheter, a deployable shunt that may be contained in the introducer sheath or catheter, a core wire, and one or more deployment features coupled to the core wire and engaging the shunt. The customization member includes a tube extending along and around a distal portion of the introducer sheath. The tube is cuttable and contains the distal end of the shunt. The length of the shunt may be customized by cutting through the tube and the shunt contained therein.

Inventors

• TRAN QUYNH
• Y .tu
• N. Bagnal
• 5. Barajas
• D.LI

Assignees

• 艾露姆技术股份有限公司

Dates

Publication Date

20260512

Application Date

20240717

Priority Date

20230822

Claims (20)

1. 1. A system for customizing a shunt for delivery into a neurovascular to treat an aneurysm, the system comprising: An elongate tubular member having a proximal end and a distal end, wherein the elongate tubular member includes an interior wall defining a lumen; a shunt comprising a proximal end and a distal end, wherein the shunt is partially contained within the lumen of the elongate tubular member in a constrained configuration, wherein the shunt extends beyond the distal end of the elongate tubular member by a first length; A deployment wire extending within the lumen of the elongate tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt such that movement of the deployment wire relative to the elongate tubular member moves the shunt relative to the elongate tubular member; a housing coupled to the elongate tubular member and defining a template for customizing the shunt, and A tube extending along and around a distal portion of the elongate tubular member, wherein the tube extends beyond the distal end of the elongate tubular member by a second length, wherein the distal end of the shunt is located within the tube, and wherein the tube is cuttable.
2. 2. The system of claim 1, wherein the elongate tubular member comprises an introducer sheath having a proximal end and a distal end, wherein the introducer sheath is cuttable.
3. 3. The system of claim 1, wherein the tube is peelably removable from the distal portion of the elongate tubular member.
4. 4. The system of claim 3, wherein the deployment wire terminates in a proximal portion of the peelable tube.
5. 5. The system of claim 1, wherein the tube comprises a proximal end, a distal end, a first longitudinal portion having a first proximal tab, and a second longitudinal portion having a second proximal tab, each of the first and second longitudinal portions extending from the proximal end of the tube to the distal end of the tube, wherein the tube is peelably removable from the distal portion of the elongate tubular member by separating the first longitudinal portion from the second longitudinal portion.
6. 6. The system of claim 1, wherein the shunt is capable of cutting into variable lengths within the tube.
7. 7. The system of claim 1, wherein the template includes equally spaced apart graduation marks, wherein the graduation marks are configured to facilitate cutting the shunt to variable lengths.
8. 8. The system of claim 7, wherein the template further comprises a cutting aperture, slit, or notch extending through the housing, wherein the cutting aperture, slit, or notch is disposed on a proximal side of the scale markings.
9. 9. The system of claim 7, wherein the template further comprises a cutting aperture extending through the housing, wherein a width of the cutting aperture constrains a cutting tool to facilitate cutting the shunt at a desired location or at a desired angle.
10. 10. The system of claim 9, wherein the template further comprises an opening extending through the housing for retraction and advancement of the tube relative to the scale markings, wherein the opening is disposed proximal to the cutting aperture.
11. 11. The system of claim 7, wherein the template further comprises an alignment member disposed below the graduation marks for guiding and holding the shunt stationary relative to the graduation marks during cutting.
12. 12. The system of claim 7, wherein the template associates the scale markings with a deployed length of the shunt.
13. 13. The system of claim 1, wherein the shunt comprises a self-expanding member having a proximal end and a distal end.
14. 14. The system of claim 1, wherein the housing comprises a packaging tray.
15. 15. A system for customizing a shunt for delivery into a neurovascular to treat an aneurysm, the system comprising: An elongate tubular member having a proximal end and a distal end, wherein the elongate tubular member includes an interior wall defining a lumen; a shunt comprising a proximal end and a distal end, wherein the shunt is partially contained within the lumen of the elongate tubular member in a constrained configuration, wherein the shunt extends beyond the distal end of the elongate tubular member by a first length; A deployment wire extending within the lumen of the elongate tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt such that movement of the deployment wire relative to the elongate tubular member moves the shunt relative to the elongate tubular member, and A housing coupled to the elongate tubular member and defining a template for customizing the shunt; wherein the at least one deployment feature comprises: a pusher extending along and around the distal portion of the deployment wire, the pusher having a distal end configured to engage the proximal end of the shunt; At least one friction tab positioned along the distal portion of the deployment wire extending distally beyond the pusher, wherein the at least one friction tab is located inside and engaged with a portion of the shunt, and An end loop extending distally from the at least one friction bump.
16. 16. A method for customizing a shunt for delivery into a neurovascular to treat an aneurysm, the method comprising: Providing a shunt delivery system, the shunt delivery system comprising: an elongate tubular member having a proximal end and a distal end, the elongate tubular member including an interior wall defining a lumen; A shunt comprising a proximal end and a distal end, wherein the shunt is partially contained within the lumen of the elongate tubular member in a constrained configuration, wherein the shunt extends beyond a distal first length of the elongate tubular member; A deployment wire extending within the lumen of the elongate tubular member, the deployment wire having a proximal end, a distal end, and a distal portion having a taper, the deployment wire including at least one deployment feature coupled to the shunt; A housing coupled to the elongate tubular member and defining a template, and A tube extending along and around a distal portion of the elongate tubular member, wherein the tube extends beyond a second length of the distal end of the elongate tubular member, wherein the distal end of the shunt is located within the tube; determining a desired length of the shunt using the template; advancing or retracting the tube relative to the housing to align the diverter with the template; cutting the tube and the shunt to thereby cut the shunt to the desired length, and Retracting the shunt into the elongate tubular member or advancing the elongate tubular member over the shunt.
17. 17. The method of claim 16, further comprising separating the tube from the distal portion of the elongate tubular member after retracting the shunt into the elongate tubular member or advancing the elongate tubular member over the shunt.
18. 18. The method of claim 17, wherein separating the tube from the distal portion of the elongate tubular member comprises peeling the tube from the distal portion of the elongate tubular member.
19. 19. The method of claim 18, wherein the deployment wire terminates in a proximal portion of the tube and within the constrained shunt.
20. 20. The method of claim 16, further comprising moving the deployment wire relative to the elongate tubular member such that the shunt moves relative to the elongate tubular member.

Description

Systems and methods for customizable shunt implants Cross-reference to related application data The present application is part of U.S. patent application Ser. No. 18/236,674, filed 8/2023, 22, the entire contents of which are incorporated herein by reference for all purposes. The subject matter of the present application is related to U.S. patent application Ser. No. 18/112,904, filed on 22 nd month 2023, which is assigned to the assignee of the present application and entitled "System and method for customizable shunt implants" (SYSTEMS AND METHODS FOR CUSTOMIZABLE FLOW DIVERTER IMPLANTS), and U.S. provisional patent application Ser. No. 63/313,205, filed on 23 nd month 2023, which is assigned to the assignee of the present application and entitled "neurovascular shunt and delivery System" (NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS), and U.S. patent application Ser. No. 18/112,963, filed on 22 nd month 2023, which is assigned to the assignee of the present application and entitled "neurovascular shunt and delivery System" (NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS), and U.S. patent application Ser. No. 18/113,010, filed on 22 nd 2023, which is assigned to the assignee of the present application and entitled "neurovascular shunt and delivery System" (NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS), and U.S. patent application Ser. No. 18/236, filed on 22 nd 2023, which is assigned to the assignee of the present application, and entitled "neurovascular shunt" delivery System "(NEROVASCULAR FLOW DIVERTER AND DELIVERY SYSTEMS), which is assigned to the assignee of the present application and is fully disclosed herein. Background Aneurysms are bulges in the blood vessel caused by a weakness in the wall of the blood vessel that dilate and fill with blood. Aneurysms often occur at vascular branches. As blood passes through weakened blood vessels, the blood pressure causes a small area to bulge out like a balloon. Although aneurysms can form in any vessel in the body, they are most commonly found in arteries that transport blood away from the heart, such as the aorta or arteries in the brain. Aneurysms formed inside the brain are known as intracranial aneurysms or cerebral aneurysms. Cerebral aneurysms typically cause significant symptoms only when they burst, rupture, or leak. Rupture or rupture of cerebral aneurysms can create a serious life-threatening condition known as subarachnoid hemorrhage. Symptoms of such bleeding include sudden and extremely painful headaches, stiffness in the neck, nausea and vomiting, and pain when looking at the light. Subarachnoid hemorrhage is life threatening and is a very serious medical emergency. Due to the serious risk of such bleeding, there is a need for a preventive, early detection and safe and effective treatment of cerebral aneurysms. However, the complex nature of the neurovasculature, including the small diameter and tortuous anatomy of many blood vessels, makes such treatment difficult. In view of the risks associated with subarachnoid hemorrhage and challenges in treating cerebral aneurysms, improved treatment systems and methods are needed. Aneurysms result from blood vessels having a wide range of diameters. The side branches and/or bifurcations increase the need to select different shunt lengths in terms of supply. Thus, hospitals must carry various shunts of different length and diameter dimensions, resulting in the need to manage a large number of SKUs. Maintaining a full range of sizes to optimally match the shunt implant to the desired location becomes economically cumbersome. There is a need to increase the flexibility of shunt length selection while reducing the number of SKUs. Disclosure of Invention The present disclosure relates to systems, devices, and methods for customizing shunts for delivery into neurovasculature for treating aneurysms. The system may include an elongate tubular member having a proximal end and a distal end. The elongate tubular member includes an inner wall defining a lumen. The shunt includes a proximal end and a distal end and defines a flow passage extending therethrough. The shunt is partially contained within the lumen of the elongate tubular member in a constrained configuration. The shunt extends beyond the distal end of the elongate tubular member by a first length. The deployment wire extends into the lumen of the elongate tubular member and into the flow channel of the shunt. The deployment wire includes a proximal end, a distal end, and a distal portion having a taper. The deployment wire includes at least one deployment feature coupled to the shunt such that movement of the deployment wire relative to the elongate tubular member moves the shunt relative to the elongate tubular member. The tube extends along and around the distal portion of the elongate tubular member. The tube extends beyond the distal end of the elongate tubular member by a second length. The distal end of the shunt is located within the t