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CA-2999263-C - GUIDEWIRE FOR CANNULA PLACEMENT

CA2999263CCA 2999263 CCA2999263 CCA 2999263CCA-2999263-C

Abstract

A guidewire for backloading and inserting a percutaneous pump affixed to a cannula includes a proximal section made of a first material, with a first diameter, a proximal end, and a distal end. The guidewire also includes a distal section made of a second material, with a second diameter which is greater than the first diameter, a distal end, and a proximal end abutting the distal end of the proximal section. The distal section of the guidewire is configured to be stiffer than the proximal section to insert the cannula in a desired location along the guidewire without displacing the guidewire.

Inventors

  • Zhenghong TAO
  • Michael Thomas Finnegan

Assignees

  • ABIOMED, INC.

Dates

Publication Date
20260505
Application Date
20160921
Priority Date
20150922

Claims (4)

  1. CLAIMS: 1. A system for the insertion of a pump configured for percutaneous insertion into a vascular system, the system comprising: a pump; a cannula with a cannula diameter, a proximal inlet, and a distal outlet, wherein the distal outlet is connected to the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane; a guidewire with a proximal section with a first stiffness and having a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness and having a second diameter greater than the first diameter, wherein the distal section is stiffer than the proximal section to insert the cannula in a desired location along the guidewire without displacing the guidewire.
  2. 2. The system of claim 1, wherein the proximal section uses a first material which is softer than a material of the pump to reduce damage to the pump during backloading of the cannula onto the guidewire.
  3. 3. The system of claim 1 or claim 2, wherein the proximal section is made of a first material with the first stiffness and the distal section is made of a second material with the second stiffness.
  4. 4. The system of any one of claims 1-3, wherein the proximal section is made of a first structure with the first stiffness and the distal section is made of a second structure with the second stiffness. 18 Date Re9ue/Date Received 2024-01-05 5. The system of any one of claims 1-4, the guidewire further comprising a distal tip connected to a distal end of the distal section. 6. The system of any one of claims 1-5, the proximal section having a rounded proximal end made of a third material. 7. The system of any one of claims 1-6, wherein a ratio of the first diameter of the proximal section over the second diameter of the distal section is 0.72. 8. The system of any one of claims 1-7, wherein the proximal section extends over 40 to 75% of a total length of the guide wire. 9. A guidewire for backloading and inserting a pump configured for percutaneous insertion into a vascular system, the guidewire comprising: a proximal section made of a first material, with a first diameter, a rounded proximal end, and a distal end; a distal section made of a second material, with a second diameter which is greater than the first diameter, a distal end, and a proximal end abutting the distal end of the proximal section, the guidewire configured to backload a cannula having a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, wherein the first material is selected to be softer than a material of the pump to reduce damage to the pump during backloading, and wherein the distal section is configured to be stiffer than the proximal section to insert the pump in a desired location along the guidewire without damaging the guidewire. 19 Date Re9ue/Date Received 2024-01-05 10. The guidewire of claim 9, wherein a stiffness of the second material is greater than a stiffness of the first material. 11. The guidewire of claim 9 or claim 10, wherein the proximal section is made of a first structure and has a first stiffness and the distal section is made of a second structure and has a second stiffness. 12. The guidewire of any one of claims 9-11, wherein the proximal section is coated but the distal section is not coated. 13. The guidewire of any one of claims 9-12, wherein a ratio of the first diameter of the proximal section over the second diameter of the distal section is 0.72. 14. The guidewire of any one of claims 9-13, wherein the proximal section extends over 40 to 75% of a total length of the guidewire. 15. The guidewire of any one of claims 9-14, the guidewire further comprising a distal tip connected to a distal end of the distal section. 16. The guidewire of any one of claims 9-15, wherein the rounded proximal end of the proximal section is made of a third material. Date Re9ue/Date Received 2024-01-05 17. Use of a guidewire that is inserted into a vascular system of a patient for loading a pump into the vascular system, wherein the guidewire extends into a cannula through a distal end of the cannula, the distal end of the cannula supporting the pump, and wherein the guidewire extends through the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, and wherein the guidewire includes a proximal section with a first stiffness and a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness greater than the first stiffness and a second diameter greater than the first diameter. 18. The method of claim 17, wherein the proximal section of the guidewire was inserted into the distal end of the cannula. 19. The use of claim 17 or claim 18, wherein the pump comprises a pump housing and one or more blades, and wherein pushing through the pump comprises pushing the guidewire through a gap between the pump housing and the one or more blades. 20. The use of any one of claims 17-19, wherein inserting into the cannula comprises inserting the proximal section of the guidewire into an extension connected to the distal end of the cannula and then inserting the proximal section of the guidewire into the distal end of the cannula. 21. The use of claim 20, wherein the pump comprises a pump housing and one or more blades, and wherein pushing through the pump comprises pushing the guidewire through a gap between the pump housing and the one or more blades. 22. Use of a guidewire that is inserted into a femoral artery of a patient for inserting into a cannula through a distal end of the cannula supporting the pump and pushing through the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, and 21 Date Re9ue/Date Received 2024-01-05 wherein the guidewire includes a proximal section with a first stiffness and a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness greater than the first stiffness and a second diameter greater than the first diameter. 23. Use of a guidewire that is inserted into a right ventricle of a patient for inserting into a cannula through a distal end of the cannula supporting the pump and pushing through the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, and wherein the guidewire includes a proximal section with a first stiffness and a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness greater than the first stiffness and a second diameter greater than the first diameter. 24. Use of a guidewire that is inserted into a left ventricle of a patient for inserting into a cannula through a distal end of the cannula supporting the pump and pushing through the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, and wherein the guidewire includes a proximal section with a first stiffness and a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness greater than the first stiffness and a second diameter greater than the first diameter. 25. The use of any one of claims 17-24, wherein the first plane of the first S bend is parallel to the second plane of the second S bend. 26. Use of a guidewire to insert a pump into a vascular system, wherein the guidewire extends into a cannula through a distal end of the cannula supporting the pump and the guidewire extends through the pump, and wherein the cannula has a three-dimensional shape with a first S bend in a first plane, and a second S bend in a second plane which is different from the first plane, and 22 Date Re9ue/Date Received 2024-01-05 wherein the guidewire includes a proximal section with a first stiffness and a first diameter, and a distal section connected to the proximal section, the distal section with a second stiffness greater than the first stiffness and a second diameter greater than the first diameter. 27. The use of claim 26, wherein the proximal section of the guidewire was inserted into the distal end of the cannula. 28. The use of claim 26 or claim 27, wherein the pump comprises a pump housing and one or more blades, and wherein the guidewire extends through a gap between the pump housing and the one or more blades. 29. The use of any one of claims 26-28, wherein the guidewire extends into an extension connected to the distal end of the cannula. 30. The use of claim 29, wherein the pump comprises a pump housing and one or more blades, and the guidewire extends through a gap between the pump housing and the one or more blades. 31. The use of any one of claims 26-30, wherein the first plane of the first S bend is parallel to the second plane of the second S bend. 23 Date Re9ue/Date Received 2024-01-05

Description

Guidewire for Cannula Placement [0001] This application claims priority to U.S. Patent Application No. 14/862,090, filed on September 22, 2015. This application also relates to U.S. Patent No. 6,007,478. Background [0002] A blood pump, such as a percutaneous intra.cardiac blood pump assembly, is introduced in the heart to deliver blood from the heart into an artery, such as the pulmonary artery. When deployed in the heart, a blood pump assembly pulls blood from the left 10 ventricle of the heart and expels blood into the aorta, or pulls blood from the right ventricle and expels blood into the pulmonary aite1y, through a cannula. Blood pump assemblies are introduced surgically or percutaneously during a cardiac procedure through the vascular system. In one common approach, pump assemblies are inserted by a catheterization procedure through the femoral artery using a guidewire. 15 [0003] An introducer is inserted into the femoral artery through an arteriotomy to create an insertion path. A placement guidewire is then advanced distal end first through the sheath into the artery. Once the guidewire has been inserted into the artery, the pump assembly, including a pump and a cannula, is backloaded onto the proximal end of the guidewire and pushed along the guidewire and into the patient. The pump assembly may then be used in 20 conjunction with a catheter. As defined herein, backloading involves inserting the proximal end of the guidewire, which remains outside the patient, into the distal end offhe catheter and then advancing the catheter distally over the wire. Backloading the pump assembly allows the guidewire to remain in position within the patient while different size catheters or sheaths are inse1ted and removed 25 during the course of a procedure, But the catmula of the pump a<ssembly can have a tortuous shape, or the cannula can be stiff. In these cases, the guidewire may not be stiff enough to allow backloading of the pump through to the pulmonary valve, and as a result the cannula of the pump may displace the guidewire out of the pulmonary valve. For example, for systems delivering blood from the inferior vena cava to an opening in the pulmonary artery, the Date Rei,:ue/Date Received 2023-04-14 WO 2017/053361 PCT/0S2016/052781 cannula of the pump may be a 3D shape \vith two "S" turns in different planes. TI1is can make backloading and insertion of the pump assembly into a patient particularly difficult. Summary [0004] Systems, methods, and devices for an improved guidewi.re for cannula placement 5 are presented. The improved guidewire facilitates insertion of the guidewire through a heart pump without damaging the pump. This improved guidewire is particularly helpful for pumps having complex or tortuous geometries, such as the IMPELLA RP pump or any other pump adapted for use in the right ventricle (e.g., bet\veen the inferior vena cava and the pulmonary artery). l O [0005] 111e improved guidewire disclosed herein can be inse1ted into the arterial system of a patient through an arteriotomy. The guidewire includes a first dista.l section, an intem1ediate pump deli.very section, and a baekloading proximal section. TI1e first distal section, is inserted first into the arterial system of the patient. 111e first distal section is flexible and has a rounded end which allows a physician to insert the guidewire with minimal 15 trauma to the patient. For exan1ple, during insertion the first distal section of the guidewire may come into contact with the walls of the patient's artery, or with a lumen placed inside the patient· s aitery. Thus, use of a material with low friction and high flexibility for the first distal section, such as a plastic or polymer, can reduce trauma and discomfort to the patient. [0006] The intennediate pump delivery section, is connected to the first distal section. 20 While the first distal section of the guidewire facilitates insertion in the patient, the intermediate pump delivery section facilitates backloading of a pump assembly onto the guide,vire. The pump assembly includes a pump affixed to a cannula. During backloading, the proximal end of the guidewire which remains outside the patient must be inserted into the pump and through the cannula, before the pump and cannula can be pushed along the 25 guidcwirc until reaching the desired site. Depending on the application, the cannula may take different shapes. For example, in the case of some pumps for the right ventricle (e.g., the IMEPLLA RP pump), the pump is located at one end of a cannula with a complex threedimensional shape, including two "S" bends in different planes. Having an intermediate pump delivery section of the guidewire which is stiffer than the first distal section facilitates 30 backloading of the stiff cannula and minimizes the risk of the stiff cannula displacing the guidewire. 'Il1e pump delivery section can have a larger diameter than the first distal section and can be made of a stiffor material. WO 2017/053