Guide wire for cannula placement

Abstract

The present invention provides a system, method, and apparatus for an improved guidewire for cannula placement. [Solution] A guidewire for backloading and inserting a transcutaneous pump fixed to a cannula includes a proximal section made of a first material, the proximal section having a first diameter, a rounded proximal end, and a distal end. The guidewire also includes a distal section made of a second material, the distal section having a second diameter larger than the first diameter, a distal end, and a proximal end that abuts against the distal end of the proximal section. The first material of the proximal section is selected to be softer than the material of the transcutaneous pump in order to reduce damage to the transcutaneous pump during backloading. The distal section of the guidewire is configured to be more rigid than the proximal section in order to insert the transcutaneous pump into the desired position without damaging the guidewire.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This non - provisional application claims the benefit of U.S. Provisional Patent Application No. 63 / 057,430, filed on July 28, 2020, entitled "SURGICAL INSTRUMENTS WITH TORSION SPINE DRIVE ARRANGEMENTS" and U.S. Provisional Patent Application No. 63 / 057,432, filed on July 28, 2020, entitled "ARTICULATION JOINT ARRANGEMENTS FOR SURGICAL INSTRUMENTS" under 35 U.S.C. § 119(e). The disclosures of these provisional applications are hereby incorporated by reference in their entirety into this specification.

Background Art

[0002] Background Blood pumps, such as percutaneous intracardiac blood pump assemblies, when introduced into the heart, pump blood from the heart into arteries such as the pulmonary artery. When operating within the heart, a blood pump assembly draws blood from the left ventricle through a cannula and pumps it into the aorta, or draws blood from the right ventricle and pumps it into the pulmonary artery. Blood pump assemblies are introduced surgically or percutaneously into the vasculature during cardiac procedures. In one common approach, the pump assembly is inserted into the femoral artery by a catheterization procedure using a guide wire.

[0003] To create an insertion route, the introducer is inserted into the femoral artery through the arterial incision. The placement guidewire is then advanced into the artery, starting distally and passing through the sheath. Once the guidewire is inserted into the artery, the pump assembly, including the pump and cannula, is backloaded onto the proximal end of the guidewire and pushed into the patient along the guidewire. The pump assembly can then be used with the catheter. Backloading as defined herein involves inserting the proximal end of the guidewire (which remains outside the patient) into the distal end of the catheter, and then advancing the catheter distally along the wire. Backloading the pump assembly allows the guidewire to remain in place within the patient while catheters or sheaths of different sizes are inserted and removed during the procedure. However, the cannula of the pump assembly can be curved or rigid. In these cases, the guidewire may not have sufficient rigidity to allow the pump backload to reach the pulmonary valve, and as a result, the guidewire may be displaced outside the pulmonary valve by the pump cannula. For example, in a system that pumps blood from the inferior vena cava to an opening in the pulmonary artery, the pump cannula may have a 3D shape with two "S"-shaped turns on different planes. This can make backloading the pump assembly and insertion into the patient particularly difficult. [Overview of the project]

[0004] overview A system, method, and apparatus for an improved guidewire for cannula placement is presented. The improved guidewire facilitates guidewire insertion into the cardiac pump without damaging the cardiac pump. This improved guidewire is particularly useful for pumps with complex or convoluted shapes, such as the Impella RP pump or other pumps adapted for use in the right ventricle (e.g., between the inferior vena cava and the pulmonary artery).

[0005] The improved guidewire disclosed herein can be inserted into the patient's arterial system through an arterial incision. The guidewire comprises a first distal section, an intermediate pump delivery section, and a backload proximal section. First, the first distal section is inserted into the patient's arterial system. The first distal section is flexible and has a rounded end that allows the physician to insert the guidewire while minimizing trauma to the patient. For example, during insertion, the first distal section of the guidewire may come into contact with the wall of the patient's artery or a lumen located within the patient's artery. Therefore, the use of a low-friction and highly flexible material for the first distal section, such as plastic or polymer, can reduce trauma and discomfort to the patient.

[0006] The intermediate pump delivery section is connected to the first distal section. The first distal section of the guidewire facilitates insertion into the patient, while the intermediate pump delivery section facilitates backloading of the pump assembly onto the guidewire. The pump assembly includes a pump fixed to a cannula. During backloading, the proximal end of the guidewire, which remains outside the patient, must be inserted into the pump and passed through the cannula before the pump and cannula are pushed along the guidewire to reach the desired site. Depending on the application, the cannula can take on various shapes. For example, in the case of some pumps for the right ventricle (e.g., the Impeller RP pump), the pump is positioned at one end of a cannula that has a complex three-dimensional shape including two "S" bends in different planes. Having an intermediate pump delivery section of the guidewire that is more rigid than the first distal section facilitates backloading of a rigid cannula and minimizes the risk of the guidewire being displaced by the rigid cannula. The pump delivery section can have a larger diameter than the first distal section and can be made of a more rigid material.

[0007] The intermediate section of the guidewire is connected to the backload proximal section. The intermediate section, also called the intermediate pump delivery section, facilitates guiding the pump assembly into place without displacing the guidewire, while the backload proximal section minimizes damage to the pump during the backloading process. Because the backload proximal section is softer and more flexible than the intermediate pump delivery section, it can be inserted into the pump without damaging it. This is particularly useful given the small size of the pump and the guidewire, which consistently complicates the initiation of the backloading process. Inserting the guidewire into the pump through the small gap between the impeller blades and the housing can require several attempts.

[0008] In some embodiments, the first distal section, intermediate pump delivery section, and backload proximal section of the guidewire have different rigidities due to differences in material, structure, shape, or combinations thereof.

[0009] The guidewire disclosed herein offers several potential advantages. The guidewire's proximal end is flexible enough to pass through the pump without unnecessary damage. At the same time, the guidewire's distal end is rigid enough to guide the cannula into place without being displaced during backloading. This can help avoid multiple insertions of the guidewire into the patient, minimizing the risk of damage to the patient's arterial system.

[0010] In one aspect, a system for inserting a transcutaneous pump includes a transcutaneous pump, a cannula, and a guidewire. The cannula has a cannula diameter, a proximal inlet, and a distal outlet. The transcutaneous pump is positioned at the distal outlet of the pump and fixed to it. The guidewire includes a proximal section having a first stiffness and a first diameter, and a distal section connected to the proximal section, having a second stiffness and a second diameter greater than the first diameter. The distal section is stiffer than the proximal section in order to insert the cannula and position it in the desired location without displacing the guidewire.

[0011] In certain embodiments, the proximal section of the guidewire uses a first material that is softer than the material of the transcutaneous pump in order to reduce damage to the transcutaneous pump during cannula backloading onto the guidewire.

[0012] In certain embodiments, the proximal section is made of a first material having a first rigidity, and the distal section is made of a second material having a second rigidity.

[0013] In certain embodiments, the proximal section is made of a first structure having a first rigidity, and the distal section is made of a second structure having a second rigidity.

[0014] In certain embodiments, the guidewire includes a distal tip connected to the distal end of the distal section.

[0015] In certain embodiments, the cannula has a three-dimensional shape having a first "S"-shaped bend in a first plane and a second "S"-shaped bend in a second plane different from the first plane.

[0016] In certain embodiments, the proximal section has a rounded proximal end made of a third material.

[0017] In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is 0.72. In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is at least 0.7. In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is 0.6 to 0.9.

[0018] In certain embodiments, the stiffness of the proximal section is lower than that of the distal section.

[0019] In certain embodiments, the proximal section extends over 40–75% of the total length of the guidewire.

[0020] In another aspect, the guidewire for backloading and inserting the transdermal pump includes a proximal section and a distal section. The proximal section is made of a first material and has a first diameter. The proximal section includes a rounded proximal end and a distal end. The distal section is made of a second material and has a second diameter. The second diameter of the distal section is larger than the first diameter of the proximal section. The proximal end of the distal section abuts against the distal end of the proximal section. The first material of the proximal section is selected to be softer than the material of the transdermal pump in order to reduce damage to the pump housing or blades during backloading of the transdermal pump onto the guidewire. The distal section is configured to be more rigid than the proximal section so that the transdermal pump can be inserted and moved to the desired position without displacing the guidewire.

[0021] In some embodiments, the rigidity of the second material is higher than that of the first material.

[0022] In some embodiments, the proximal section is made of a first structure and has a first rigidity, and the distal section is made of a second structure and has a second rigidity.

[0023] In some embodiments, the proximal section is made of a first structure and has a first rigidity, and the distal section is made of a second structure and has a second rigidity.

[0024] In certain embodiments, the stiffness of the proximal section is lower than that of the distal section.

[0025] In certain embodiments, the proximal portion is coated, while the distal portion is not.

[0026] In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is 0.72. In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is at least 0.7. In certain embodiments, the ratio of the diameter of the proximal section to the diameter of the distal section is 0.6 to 0.9.

[0027] In certain embodiments, the proximal end extends over 40 - 75% of the total length of the guide wire.

[0028] In certain embodiments, the proximal segment includes a distal tip connected to the distal end of the distal segment.

[0029] In certain embodiments, the rounded proximal end of the proximal segment is made of a third material.

[0030] In another aspect, a method for inserting a percutaneous pump includes inserting a guide wire through the distal end of a cannula that supports the percutaneous pump into the cannula, and pushing the guide wire through the percutaneous pump and the cannula. The guide wire includes a proximal segment having a first rigidity and a first diameter, and a distal segment connected to the proximal segment and having a second rigidity and a second diameter greater than the first diameter. The distal segment is more rigid than the proximal segment to insert the cannula to a desired position without shifting the guide wire.

[0031] [Inventive Concept 1001] A percutaneous pump; A cannula having a cannula diameter, a proximal inlet, and a distal outlet in contact with the percutaneous pump; A guide wire having a proximal segment having a first rigidity and a first diameter, and a distal segment connected to the proximal segment and having a second rigidity and a second diameter greater than the first diameter A system for inserting a percutaneous pump, comprising: The distal segment is more rigid than the proximal segment to insert the cannula to a desired position without shifting the guide wire. The system. [Inventive Concept 1002] The system of Inventive Concept 1001, wherein the proximal segment uses a first material that is softer than the material of the percutaneous pump to reduce damage to the percutaneous pump during backloading of the cannula onto the guide wire. [Inventive Concept 1003] The system of the present invention 1001, wherein the proximal section is made of a first material having a first rigidity, and the distal section is made of a second material having a second rigidity. [Invention 1004] The system of the present invention 1001, wherein the proximal section is made of a first structure having a first rigidity, and the distal section is made of a second structure having a second rigidity. [Invention 1005] The system of the present invention 1001 further includes a distal tip connected to the distal end of the guide wire. [Invention 1006] The system of the present invention 1001, wherein the cannula has a three-dimensional shape having a first S-shaped bend in a first plane and a second S-shaped bend in a second plane different from the first plane. [Invention 1007] The system of the present invention 1001, wherein the proximal section has a rounded proximal end made of a third material. [Invention 1008] The system of the present invention 1001, wherein the ratio of the diameter of the proximal section to the diameter of the distal section is 0.72. [Invention 1009] The system of the present invention 1001, wherein the proximal section extends over 40-75% of the total length of the guidewire. [Invention 1010] It is made of a first material and has a first diameter, a rounded proximal end, and a distal end, with a proximal section and a distal end; A distal section made of a second material, having a second diameter larger than the first diameter, a distal end, and a proximal end that abuts against the distal end of the proximal section. A guide wire for backloading and inserting a transdermal pump, including In order to reduce damage to the transdermal pump during backloading, the first material is selected to be softer than the material of the transdermal pump. In order to insert the transcutaneous pump into the desired position without damaging the guide wire, the distal section is configured to be more rigid than the proximal section. The aforementioned guide wire. [Invention 1011] A guide wire according to the present invention 1011, wherein the rigidity of the second material is higher than the rigidity of the first material. [Invention 1012] The guide wire of the present invention 1011, wherein the proximal section is made of a first structure and has a first rigidity, and the distal section is made of a second structure and has a second rigidity. [Invention 1013] A guidewire according to the present invention 1011, wherein the proximal portion is coated, but the distal portion is not coated. [Invention 1014] A guidewire according to the present invention 1011, wherein the ratio of the diameter of the proximal section to the diameter of the distal section is 0.72. [Invention 1015] The guide wire of the present invention 1011, wherein the proximal section extends over 40-75% of the total length of the guide wire. [Invention 1016] A guidewire according to the present invention 1011, further comprising a distal tip connected to the distal end of the distal section. [Invention 1017] The guide wire of the present invention 1011, wherein the rounded proximal end of the aforementioned proximal section is made of a third material. [Invention 1018] The process of inserting a guidewire into a cannula that supports a transcutaneous pump by passing it through the distal end of the cannula; and Steps to push the guide wire through the transdermal pump. A method for inserting a transdermal pump, including, The guide wire includes a proximal section having a first stiffness and a first diameter, and a distal section connected to the proximal section having a second stiffness and a second diameter larger than the first diameter, and In order to insert the cannula into the desired position without displacing the guidewire, the distal section is more rigid than the proximal section. The aforementioned method. After considering this disclosure, those skilled in the art will likely conceive of variations and modifications. The disclosed features may be combined with any one or more other features described herein and in any combination. They may be implemented through partial combinations (including multiple dependent and subcombinations). The various features described above, including any of their components, may be combined or integrated as other systems. Furthermore, certain features may be omitted or not implemented at all. [Brief explanation of the drawing]

[0032] The aforementioned and other objectives and benefits will become clear when the following detailed description is considered in conjunction with the attached drawings. Throughout the drawings, similar reference numbers refer to similar parts.

[0033] [Figure 1] An exemplary embodiment of a cannula assembly is shown. [Figure 2] A lateral cross-sectional view of a conventional guidewire is shown. [Figure 3] This illustrates exemplary damage to a transdermal pump blade resulting from backloading of a transdermal pump onto a conventional guidewire. [Figure 4] This illustrates exemplary damage to a transdermal pump blade resulting from backloading of a transdermal pump onto a conventional guidewire. [Figure 5] A lateral cross-sectional view of a first exemplary embodiment of the guide wire is shown. [Figure 6] A lateral cross-sectional view of a second exemplary embodiment of the guide wire is shown. [Figure 7] A lateral cross-sectional view of a third exemplary embodiment of the guide wire is shown. [Figure 8] A lateral cross-sectional view of a fourth exemplary embodiment of the guide wire is shown. [Figure 9]Figure 2 shows a table of data regarding the properties of the guidewire and any of the guidewires shown in Figures 2-8. [Figure 10] Figure 2 shows a table of data regarding the properties of the guidewire and any of the guidewires shown in Figures 2-8. [Figure 11] Figures 5-8 show a transcutaneous pump backloaded onto a guidewire in an exemplary embodiment. [Figure 12] This illustrates the process of inserting a guidewire. [Modes for carrying out the invention]

[0034] Detailed explanation To provide an overall understanding of the systems, methods, and apparatus described herein, certain exemplary embodiments are described. While the embodiments and features described herein are specifically described in relation to their use in connection with percutaneous blood pump systems for the right ventricle, it will be understood that all components and other features outlined below may be combined with each other in any suitable manner and adapted and applied to other types of cardiac treatments and assisted cardiac devices, including blood pump systems or balloon pumps for the left ventricle, and cardiac assisted devices implanted using surgical incisions.

[0035] The systems, methods, and apparatus described herein provide a guidewire having a first proximal section and a second distal section, which allows a cannula to be inserted onto the guidewire without displacing the guidewire and without damaging the pump coupled to the cannula. The proximal section of the guidewire is less rigid than the distal section of the guidewire due to the shape or material of the proximal section. For example, the proximal section of the guidewire may have a smaller diameter than the distal section. In another example, the proximal section of the guidewire may be made of a material that is less rigid than the material of the distal section of the guidewire. In yet another example, the proximal section of the guidewire may have a structure that is less rigid than the structure of the distal section of the guidewire. The lower rigidity of the proximal section compared to the rigidity of the distal section allows a physician to easily insert the guidewire using a percutaneous pump positioned at the distal end of the cannula. In particular, a physician can insert the proximal section of the guidewire into the gap located between the housing and the blade of the percutaneous pump without damaging the blade and without damaging or rupturing the housing.

[0036] Figure 1 shows an exemplary embodiment of a blood pump assembly 100. The blood pump assembly 100 includes a pump 101, a pump housing 103, a proximal end 105, a distal end 107, a cannula 108, an impeller 109, an extension 102, a catheter 112, an inlet area 110, an outlet area 106, and a blood outlet 117. The catheter 112 is connected to the inlet area 110 of the cannula 108. The inlet area 110 is located near the proximal end 105 of the cannula, and the outlet area 106 is located near the distal end 107 of the cannula 108. The inlet area 110 includes a pump housing 103 having a circumferential wall 111 extending around the axis of rotation 113 of an impeller blade 115, which is positioned radially outward on the inner surface with respect to the axis of rotation 113 (not shown) of the impeller 109 (not shown). The impeller 109 is rotatably coupled to the pump 101 in an inlet area 110 adjacent to a blood outlet 117 formed in the wall 111 of the pump housing 103. According to the embodiment, the pump housing 103 may be made of metal. The extension 102, also called the "pigtail," is connected to the distal end 107 of the cannula 108 and helps to stabilize the blood pump assembly 100 and position it correctly within the heart. The pigtail 102 can be configured in a straight or partially curved shape. The pigtail 102 may be made of at least partially flexible material and may have dual rigidity.

[0037] The cannula 108 has a shape that matches the anatomical structure of the patient's right ventricle. In this exemplary embodiment, the cannula has a proximal end 105 configured to be located near the patient's inferior vena cava and a distal end 107 configured to be located near the pulmonary artery. The cannula 108 includes a first segment S1 extending from the inflow area to point B between the inlet area 110 and the outlet area 106. The cannula 108 also includes a second segment S2 extending from point C, located between the inlet area 110 and the outlet area 106, to the outlet area 106. In some embodiments, B and C may be the same location along the cannula 108. The first segment S1 of the cannula forms an "S" shape in the first plane. In some embodiments, segment S1 may have a curvature of 30° to 180°. The second segment S2 of the cannula forms an "S" shape in the second plane. In some embodiments, segment S2 can have a curvature of 30° to 180° (e.g., 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, or 170°). The second plane can be different from the first plane. In some embodiments, the second plane is parallel to or identical to the first plane.

[0038] In some embodiments, the blood pump assembly 100 is inserted percutaneously into the right ventricle through the femoral artery. Alternatively, in some embodiments, the blood pump assembly 100 may be inserted percutaneously into the left ventricle through the femoral artery. When properly positioned, the blood pump assembly 100 pumps blood from an inlet area 110 located in the patient's left ventricle through a cannula 108 to a blood outlet 117 of a pump housing 103 located in the ascending aorta.

[0039] Figure 2 shows a lateral cross-sectional view of a conventional guidewire 200. The conventional guidewire includes a distal section 210, a distal tip 212, a coil wire 214, a core wire 216, a transition region 218, a proximal section 220, a proximal end 222, and a transition region 218. The coil wire 214 surrounds the core wire 216. The core wire 216 has a diameter that decreases from the transition region 218 to the tip of the distal section 212. The distal section 210 has a length L2 which is 25-50% of the total length of the core wire 216. The core wire 216 also includes a proximal section 220 that extends between the proximal end 4222 and the transition region 218. The proximal section 220 has a constant diameter. The proximal section 220 has a length of 75-50% of the total length of the core wire 216. The distal section 210 of the core wire is more flexible than the proximal section of the guidewire 200. This allows the physician to insert the guidewire into the patient first, in order to minimize damage to the patient's arterial system.

[0040] Figures 3 and 4 show exemplary damage to the blades of a transdermal pump. Exemplary blades 310 and 430 include portions 320 and 440 that have been scratched or dented by attempting to insert a conventional guidewire between the pump housing (e.g., pump housing 103 in Figure 1) and the blade (e.g., impeller blade 115 in Figure 1). In this example, contact between the guidewire and the pump element results in the pump element being scratched or dented, rather than the guidewire being scratched or dented (as shown in Figures 2 and 3). Although only scratches and dents are shown, in some cases the pump housing may also be punctured when inserting a conventional guidewire. This is a concern, especially when using a guidewire made of a material with a higher scratch hardness, indentation hardness, or rebound hardness than the material used for the pump element.

[0041] As described above, backloading and inserting the pump assembly (e.g., pump assembly 100 in Figure 1) into the patient can be particularly difficult when the guidewire (e.g., guidewire 200 in Figure 2) does not have sufficient rigidity. Therefore, some physicians may use a more rigid guidewire to backload the pump (e.g., pump 101 in Figure 1) without displacing the guidewire 200 outside the pulmonary valve. However, for certain pumps, such as impeller RP pumps used in conjunction with an "S"-shaped turn cannula (e.g., cannula 108 in Figure 1), a more rigid guidewire may not be a feasible solution. In exemplary embodiments of impeller RP pumps (e.g., pump 101 in Figure 1), the pump is very small, and the passage between the pump housing (e.g., pump housing 103 in Figure 1) and the pump blades (e.g., impeller blade 115 in Figure 1) is on the order of millimeters. Furthermore, components of an impeller RP pump, such as the housing (e.g., housing 103 in Figure 1) and blades (e.g., impeller blade 115 in Figure 1), are particularly expensive to manufacture or replace due to their size and complexity. Instead of passing the guidewire straight through the aforementioned gap, any unwanted contact between the guidewire and the pump elements can cause damage. This is especially true for stiff guidewires, such as those made of materials with higher scratch hardness, indentation hardness, or rebound hardness than the materials used for the pump elements. Guidewires that are stiffer overall due to increased diameter or material properties can damage the pump housing or blades even more severely than conventional guidewires.

[0042] Figure 5 shows a lateral cross-sectional view of a first exemplary embodiment of the guidewire 500. The guidewire 500 includes a soft distal section 510, a distal tip 512, a coiled wire 514, a core wire 516, a transition section 518, an intermediate pump delivery section 530, a transition section 532, a backloaded proximal section 540, and a proximal tip 542. The soft distal section 510 extends between the transition section 518 and the distal tip 512. During use, the soft distal section 510 is inserted into the patient first. The soft distal section 510 includes a core wire 516 and a coiled wire 518 wound around the core wire 516. The core wire 516 has a diameter that decreases from the transition section 518 to the distal tip 512. Instead of having one proximal section, as in the guidewire 200, the guidewire 500 includes two sections, namely an intermediate pump delivery section 530 and a backload proximal section 540. The intermediate pump delivery section 530 and the backload proximal section 540 are coupled to the intermediate pump delivery section 530 by a transition section 532. The intermediate pump delivery section 530 extends between the transition section 532 and the transition section 518. The intermediate pump delivery section 530 is the portion of the guidewire 500 having the largest diameter. The intermediate pump delivery section 530 may have a constant diameter. In some embodiments, the intermediate pump delivery section 530 is not the widest section of the guidewire.

[0043] The backload proximal section 540 extends between the proximal tip 542 and the transition section 532. The backload proximal section 540 has a constant diameter. In some embodiments, the diameter of the proximal section 540 varies. The materials and construction of the backload proximal section 540 and the intermediate pump delivery section 530 may be similar or identical. The backload proximal section 540 is more flexible than the intermediate pump delivery section 530 because it has a smaller diameter than the intermediate pump delivery section 530. The smaller diameter of the backload proximal section facilitates the introduction of the guide wire into the pump with less force. In some embodiments, the backload proximal section 540 is more flexible than the intermediate pump delivery section 530 because it is formed of a material or construction that is less rigid than the material or construction of the intermediate pump delivery section 530.

[0044] In certain embodiments, the backload proximal section 540 is more flexible than the intermediate pump delivery section 530 by having a material composition consisting of 100% material that is more flexible than the material of the intermediate pump delivery section 530. The intermediate pump delivery section 530 may have a material composition consisting of 100% material that is more rigid than the material of the backload proximal section 540. The more rigid material of the intermediate pump delivery section 530 may consist of any number of materials, including polyurethane or resin-impregnated fibers. The more flexible material may consist of any number of materials, including silicone compounds. In some embodiments, two different materials may have the same chemical composition but may have different degrees of polymerization, crystallinity, or other arbitrary properties.

[0045] The material of the backload proximal section 540 may be selected to reduce damage to the pump element in the event of undesirable contact between the guide wire and any pump element. In particular, the material of the backload proximal section may be selected to have lower scratch hardness, indentation hardness, or rebound hardness than the material used for the pump element.

[0046] The proximal tip 542 of the backload proximal section 540 is rounded and made of a different material from the rest of the backload proximal section 540, or is coated with it. For example, a lubricating coating or lubricating material can be used for the proximal tip 542. This allows the physician to more easily insert the guidewire proximal tip 542 and the backload proximal section 540 into the pump and cannula. On the other hand, these features can help reduce damage to the blades and housing of the percutaneous pump into which the guidewire is inserted. The proximal tip 542 can be attached to the backload proximal section 540 by adhesive or solvent bonding, mechanical fastening, insert molding or any other suitable joining mechanism or a combination thereof. Alternatively, the proximal tip 542 can be integrated with the backload proximal section.

[0047] Figure 6 shows a lateral cross-sectional view of a second exemplary guidewire 600 in a particular embodiment. The guidewire 600 includes a soft distal section 610, a distal tip 612, a coil wire 614, a core wire 616, a transition zone 618, an intermediate pump delivery section 630, a transition zone 632, a backload proximal section 640, and a proximal tip 642. The guidewire 600 includes a distal section 610 that extends between the transition zone 618 and the distal tip 612, which is initially inserted into the patient. The soft distal section 610 includes a core wire 616 having a diameter that decreases from the transition zone 638 to the distal tip 612. The soft distal section 610 also includes a coil wire 614 that is wound around the core wire 616. The soft distal section 610 extends over a length L2 that can be 25-50% (e.g., 30%, 35%, 40%, 45%) of the total length of the guidewire 600. Preferably, length L2 is 25-35% of the total length of the guidewire 600. More preferably, length L2 is 30% of the total length of the guidewire 600. The guidewire 600 further includes, for example, two sections instead of the proximal section 220: an intermediate pump delivery section 630 and a backload proximal section 640 coupled to the intermediate pump delivery section 630 by a transition section 632. The intermediate pump delivery section 630 extends between the transition section 632 and the transition section 618. The intermediate pump delivery section 630 can have a constant diameter D3 that can be 0.02-0.03”, with a preferred value of 0.025”. The intermediate pump delivery section 630 has a length L3 which is 30% to 60% (e.g., 35%, 40%, 45%, 50%, 55%) of the guide wire length. In particular, D3 can be a diameter larger than any diameter of the back load proximal section 640. The back load proximal section 640 has a constant diameter D4 which can be between 0.017” and 0.019” and a preferred value is 0.018”. The back load proximal section 640 can have a length L4 which is 40% to 75% (e.g., 45%, 50%, 55%, 60%, 65%, 75%) of the guide wire length. For example, for a guide wire with a total length of 260 mm, the back load proximal section 640 has a length of at least 100 mm.

[0048] At least one advantage of the backload proximal section 640 having a diameter D4 smaller than the intermediate pump delivery section 630 is increased flexibility of the backload proximal section 640. Another advantage is a reduction in the overall weight of the guidewire. This weight reduction is achieved because the backload proximal section 640 is made lighter and occupies a substantial portion (e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more) of the total length of the guidewire 600. A lighter guidewire is easier for physicians to insert into patients and may cause less damage when inserted into a pump, such as the pump 101 of the blood pump assembly 100.

[0049] The backload proximal section 640 may be terminated with a proximal tip 652. The proximal tip 642 may be rounded, made of a different material from the backload proximal section 640, or coated with a different material. For example, a lubricating coating or lubricating material can be used for the proximal tip 652. This allows the physician to more easily insert the proximal tip of the guidewire and the backload proximal section into the pump and cannula. On the other hand, these features can help reduce damage to the blades and housing of the percutaneous pump into which the guidewire is inserted.

[0050] Figure 7 shows a lateral cross-sectional view of a third exemplary guidewire 700 in a particular embodiment. The guidewire 700 includes a soft distal section 710, a distal tip 712, a coil wire 714, a core wire 716, a transition zone 718, an intermediate pump delivery section 730, a transition zone 732, a backload proximal section 740, and a proximal tip 742. The guidewire distal section 710 extends between the transition zone 718 and the distal tip 712 and is initially inserted into the patient. The soft distal section 710 includes a core wire 716 having a diameter that decreases from the transition zone to the distal tip 712. The soft distal section 710 includes a coil wire 714 that is wound around the core wire 716. The guidewire 700 further includes two sections, namely an intermediate pump delivery section 730 and a backload proximal section 740, instead of, for example, a proximal section 220. The backload proximal section 740 is connected to the intermediate pump delivery section 730 by a transition section 732. The material of the backload proximal section 740 is different from the material of the intermediate pump delivery section 730. The transition section 732 may be a conical section having a first diameter equal to the diameter of the backload proximal section 740 and a second diameter equal to the diameter of the intermediate pump delivery section. Alternatively, the transition section 732 may be a welded section. The transition section 732 may be an abrupt transition resulting from joining two sections of different flexibility in a butt joint or stepped joint. Alternatively, the transition section 732 may be a gradual transition by using a composite structure in which the content of the more flexible material (e.g., the main material of the backload proximal section 740) gradually replaces the content of the more rigid material (e.g., the material of the intermediate pump delivery section 730). The use of different materials for the backload proximal section 740 and the intermediate pump delivery section 730 allows one section (e.g., the backload proximal section 740) to be optimized for insertion and the other section (e.g., the intermediate pump delivery section 730) to be optimized for pump delivery. This can also reduce the weight, cost, or both of the guidewire.

[0051] Figure 8 shows a lateral cross-sectional view of a fourth exemplary guidewire 800 in a particular embodiment. The guidewire 800 includes a soft distal section 810, a distal tip 812, a coil wire 814, a core wire 816, a transition zone 818, an intermediate pump delivery section 830, a transition zone 832, a backload proximal section 840, and a proximal tip 842. The guidewire distal section 810, which is initially inserted into the patient, extends between the transition zone 818 and the distal tip 812. The soft distal section 810 includes a core wire 816 having a diameter that decreases from the transition zone 838 to the distal tip 812. The soft distal section 810 may also include a coil wire 814 wound around the core wire 816. The guidewire 800 further includes, for example, two sections instead of a proximal section 220: an intermediate pump delivery section 830 and a backload proximal section 840 coupled to the intermediate pump delivery section 830 by a transition section 832. The intermediate pump delivery section 830 may have a first structure, which is a core wire having a constant diameter. The backload proximal section 840 may have a second structure, which includes a core wire 843 and a coil wire 844. The core wire 816 may have a constant diameter. Alternatively, the core wire 843 may be tapered, having a first larger diameter adjacent to the transition section 832 and a second smaller diameter adjacent to the proximal tip 842. The coil wire 844 may be wound around the core wire 843. Similar to the core wire 843, the coil wire 844 may have a constant diameter or a diameter that decreases from the transition section 832 to the proximal tip 842.

[0052] The coil wire 844 can provide resistance to radial deformation, allowing the guide wire 800 to regain its original shape even after deformation that may occur during placement or manipulation within the heart. The coil wire 844 may have any number of cross-sectional shapes, including circular or rectangular cross-sections. The coil wire 844 may also have a varying axial density that alters the elasticity or flexibility of the backload proximal section 840.

[0053] Figures 9 and 10 are tables summarizing the dimensions and material properties of exemplary guide wires shown in Figures 2 and 5-8.

[0054] Figure 9 is a table showing the diameter, length, function, material, and coating of guidewires of the related technology (e.g., guidewire 200 in Figure 2) and improved guidewires having proximal and distal sections (e.g., any of the guidewires in Figures 5-8). Figure 9 shows that the outer diameter D1 of the related technology guidewire is the same as the outer diameter D1 of the improved guidewire distal section, 0.025”. In some embodiments, the outer diameter D1 of the improved guidewire distal section is 0.018”. Figure 9 shows that the diameter D2 of the improved guidewire proximal section is 0.018”. In some embodiments, the diameter of the improved guidewire proximal section is 0.014”. The function of the related technology guidewire is both steering and guidance, but the improved guidewire proximal section is used for steering and the improved guidewire distal section is used for guidance. Figure 9 includes an exemplary list of materials for both the related technology guidewire and the improved guidewire (proximal and distal sections). For example, the related technology guidewire is generally made of stainless steel. The improved guidewire proximal section may consist of a stainless steel core wire with a coating, coil jacket, or plastic tube jacket. Alternatively, the proximal section may consist of a nitinol wire or plastic string. The improved guidewire proximal section may be coated. Similarly, the improved guidewire distal section may consist of a stainless steel core wire with a coating, coil jacket, or plastic tube jacket. Alternatively, the improved guidewire distal section may consist of a nitinol wire.

[0055] Figure 10 shows the force metrics for the proximal section of a guidewire of the related technology with an outer diameter of 0.025” (e.g., 220 in Figure 2) and the proximal section of an improved guidewire with an outer diameter of 0.018”. When using the guidewire of the related technology, the maximum backload force passing through the pump is 1.5 Newtons. This maximum backload force is significantly reduced to 0.3 N by the improved proximal guidewire. Furthermore, using the improved guidewire reduces the maximum sliding force of the guidewire from an initial resistance of 1.9 N to a stable sliding force of 0.7 N.

[0056] Figure 11 shows a system 1100 in which a percutaneous pump is already backloaded onto a guidewire in one of the exemplary embodiments of Figures 5-8. System 1100 includes a guidewire 1102, a pigtail 1104, and a cannula 1108. In the example of Figure 11, system 1100 is curved to follow the shape of a pulmonary valve (not shown). When a physician backloads the pump and cannula 1108 onto the guidewire 1102, the guidewire 1102 passes through the pigtail 1104, through the cannula 1108, and enters the gap located between the pump blades and the housing.

[0057] Figure 12 shows a method 1200 for inserting a percutaneous pump according to a particular embodiment. Method 1200 may be performed to insert a subcutaneous pump, for example pump 101, into a guidewire, including a guidewire as described in any of the embodiments described above. Method 1200 may be performed by step 1210, in which a guidewire that has been previously placed in the patient's artery is passed through the distal end of a cannula supporting the percutaneous pump and inserted into the cannula. Method 1200 further includes step 1220, in which the guidewire is pushed through the percutaneous pump. The guidewire that is passed through and pushed into the percutaneous pump includes a proximal section having a first stiffness and a first diameter, and a distal section connected to the proximal section having a second stiffness and a second diameter greater than the first diameter. The distal section of the guidewire is stiffer than the proximal section in order to insert the cannula into the desired position without displacing the guidewire.

[0058] At least one advantage of Method 1200 is that it reduces the number of guidewire insertions into the patient, minimizing the risk of damage to the patient's arterial system. Method 1200 reduces the number of insertions into the patient by using guidewire backloading. Another advantage of Method 1200 is that it facilitates the insertion of the guidewire into the pump, for example, the pump 101 of the blood pump assembly 100. This reduces the risk of damage during insertion.

[0059] In an alternative embodiment, the percutaneous pump may be backloaded onto the guidewire before the guidewire is placed in the patient's artery. In an alternative embodiment, the percutaneous pump may be backloaded onto the guidewire before the percutaneous pump is connected to the cannula.

[0060] After considering this disclosure, those skilled in the art will likely conceive of variations and modifications. For example, in some embodiments, any of the alternative embodiments shown in Figures 5-8 may be combined. For instance, the coil structure at the proximal end of the guidewire in Figure 7 may be combined with the various guidewire materials described in relation to Figures 5-6. In another example, the coil structure at the proximal end of the guidewire in Figure 7 may be combined with the weld transition described in relation to Figure 6. The disclosed features may be realized in any combination and partial combination (including multiple dependent and partial combinations) with one or more other features described herein. The various features described above may be combined or integrated as other systems, including any of their components. Furthermore, certain features may be omitted or not realized.

[0061] It is important to note that the structure and arrangement of the apparatus or its components as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments are described in detail in this disclosure, those skilled in the art who consider this disclosure will readily understand that many modifications are possible without substantially departing from the novel teachings and merits of the disclosed subject matter (e.g., changes in the size, dimensions, structure, shape and proportions of various elements, parameter values, mounting structures, material use, color, orientation, etc.). For example, elements shown as being formed as a single unit may consist of multiple parts or elements, the arrangement of elements may be reversed or otherwise changed, and the nature or number of separate elements or positions may be changed. Any process or method sequence may be changed or rearranged according to alternative embodiments. Furthermore, other substitutions, modifications, changes and omissions may be made in the design, operating conditions and configurations of the various exemplary embodiments without departing from the scope of this disclosure.

[0062] While various inventive embodiments are described and illustrated herein, those skilled in the art will readily conceive of a variety of other mechanisms and / or structures for performing a function and / or obtaining one or more of the results and / or benefits described herein, and each such change and / or modification will be considered within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily understand that, unless otherwise noted, any parameters, dimensions, materials and configurations described herein are intended to be illustrative, and that actual parameters, dimensions, materials and / or configurations will depend on the specific application in which the inventive teachings are used. Those skilled in the art will be able to recognize or confirm many equivalents of the particular inventive embodiments described herein by means of experiments that are merely customary. Thus, it will be understood that the embodiments are presented only as examples, and that within the scope of the claims and their equivalents, the inventive embodiments may be carried out in ways other than those specifically described and claimed. The inventive embodiments of this disclosure relate to each of the individual features, systems, articles, materials, kits and / or methods described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included in the inventive scope of this disclosure, provided that they are not contradictory.

[0063] In relation to this disclosure, the term “joining” means a direct or indirect joining of two members to one another. Such joinings may be static or movable. Such joinings may be achieved by two members or two members and any further intermediate members being formed together as a single integral body, or by two members or two members and any further members being attached to one another. Such joinings may be permanent, or they may be removable or detachable.

[0064] As used herein and in the claims, the singular indefinite articles “a” and “an” should be understood to mean “at least one” unless it is clearly indicated otherwise. As used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when dividing items in a list, “or” or “and / or” must be interpreted as inclusive, that is, including the number of elements or at least one in the list, but also including two or more, and optionally including further items not in the list. Only words that are clearly indicated otherwise, such as “only one of” or “exactly one of,” mean the inclusion of the number of elements or exactly one element in the list. In general, the word "or" as used herein should be interpreted as indicating an exclusive choice (i.e., one or the other, and not both) only when followed by a word indicating exclusivity, such as "either of," "one of," "only one of," or "exactly one of."

[0065] In the claims and the above specification, all transitional phrases (connecting words), such as "comprising," "including," "carrying," "having," "containing," "accompanying," "holding," and "composed of," should be understood as non-exclusive, meaning "including, but not limited to."

[0066] Unless otherwise stated, the claims of this patent should not be read as being limited to the order or elements described herein. It should be understood that various modifications in form and detail may be made by those skilled in the art without departing from the spirit and scope of the claims. All embodiments that fall within the spirit and scope of the following claims and their equivalents are claimed.

[0067] Examples of modifications, substitutions, and alterations are verifiable by those skilled in the art and can be implemented without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference as a whole and constitute part of this application.

Claims

[Claim 1] A pump including a housing and a first rigid blade; A cannula having a cannula diameter, a proximal inlet, and a distal outlet; A system for inserting a pump configured for percutaneous insertion into a vascular system, comprising a guidewire having a proximal section having a second rigidity and a first diameter, and a distal section connected to the proximal section having a third rigidity and a second diameter larger than the first diameter, The system wherein the distal section is more rigid than the proximal section in order to insert the cannula into a desired position without displacing the guidewire, and the first rigidity of the blade of the pump is higher than the second rigidity in order to reduce damage to the blade of the pump when inserting the proximal section of the guidewire between the housing and the blade.

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