Transluminal delivery system

Abstract

A device including a delivery tool sized for percutaneous delivery of an implant to a heart includes (a) a catheter (132) defining a catheter lumen (133), (b) a shaft (1034) at least a portion slidably disposed within the catheter lumen (133), and (c) a distal portion (304) defining a distal portion axis. The distal portion (304) further comprises: (i) a capsule (1064) switchable between a first state in a position at a first distance from the distal end of the catheter (132) to a second state in a position at a second distance further from the distal end of the catheter (132); and (ii) a support (300) configured to expand when the capsule (1064) is switched from the first state to the second state. Other embodiments are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the U.S. provisional patent application No. 63 / 350,200, filed on June 8, 2022, entitled “Transluminal Delivery System,” by Albitov et al.

[0003] This application is related to international application PCT / IL2021 / 051433, filed on December 2, 2021, with the invention name “Transluminal Delivery System”, published as WO2022 / 118316A, claiming priority to the U.S. application and being a partial continuation of U.S. application 17 / 399,594, filed on August 11, 2021, with the invention name “Transluminal Delivery System”, published as US2022 / 0175526, US2022 / 0175526 claims priority to U.S. provisional application 63 / 120,808, filed on December 3, 2020, with the invention name “Transluminal Delivery System”.

[0004] Each of the above applications is assigned to the assignee of the present application and is incorporated herein by reference.

[0005] Technical field of the invention

[0006] Some applications of the present invention generally relate to transluminal implant delivery systems. More specifically, some applications of the present invention relate to prosthetic heart valves and transluminal delivery systems thereof. Background Art

[0007] Dilatation of the heart valve annulus, such as that caused by ischemic heart disease, prevents the valve leaflets from fully coapting when the valve closes. The reverse flow of blood from the ventricles to the atria results in an increase in total stroke volume and a decrease in cardiac output, which in turn leads to eventual ventricular collapse due to volume and pressure overload of the atria. Summary of the invention

[0008] Applications of the present invention relate to devices and methods for delivering implants to a subject.

[0009] For some applications, according to the invention, there is provided a device for use at a heart of a subject, the device comprising:

[0010] A delivery vehicle sized and configured for percutaneous delivery of an implant to a heart, the delivery vehicle comprising:

[0011] a catheter, defining a catheter lumen,

[0012] a shaft, at least a portion of which is slidably disposed within the lumen of the catheter, and

[0013] a distal portion defining a distal portion axis and comprising:

[0014] A capsule comprising:

[0015] configured to receive at least a portion of the implant,

[0016] connected to the distal portion of the shaft, and

[0017] Slidable relative to the catheter along the distal portion axis to switch the capsule from a first state at a first distance from the distal end of the catheter to a second state at a second distance from the distal end of the catheter, wherein the second distance is greater than the first distance; and

[0018] A support member, wherein:

[0019] fixedly connected to the distal end region of the catheter,

[0020] extending along the distal portion axis from the distal end of the catheter toward the capsule, and

[0021] The capsule is configured to expand when the capsule switches from the first state to the second state: from a contracted state in which the support has a first length to an expanded state in which the support has a second length.

[0022] In one application, the proximal region of the support is fixedly connected to the distal region of the catheter.

[0023] In one application, the support member is configured to define a support member lumen, and a portion of the shaft is disposed within the support member lumen, wherein when the support member is in the expanded state, the stiffness of the support member is greater than the stiffness of the portion of the shaft.

[0024] In one application, the support member is configured such that when the capsule switches from the first state to the second state, the support member self-expands from the contracted state to the expanded state.

[0025] In one application, the capsule is reversibly slidable relative to the catheter along the distal portion axis so that the capsule can switch from the second state to the first state.

[0026] The support member is configured to contract from the expanded state to the contracted state when the capsule switches from the second state to the first state.

[0027] In one application, when the support member is in the contracted state, the support member has a radial thickness of 1-3 mm.

[0028] In one application, when the support member is in the contracted state, the support member has a length of 4-18 mm.

[0029] In one application, when the support member is in the expanded state, the support member has an expanded length between 10 mm and 60 mm.

[0030] In one application, when the support member is in the contracted state, the support member has a contracted length, and an expanded length is 10-50 mm longer than the contracted length.

[0031] In one application, when the support member is in the contracted state, the support member has a contracted length, and the expanded length is 2 to 5 times the contracted length.

[0032] In one application, the support member is configured such that when the support member is in the expanded state, the support member extends from the distal end of the catheter to the capsule.

[0033] In one application, the support member is configured such that when the support member expands from the contracted state to the expanded state, the support member extends from the distal end of the catheter to the capsule.

[0034] In one application, the support member includes a plurality of coaxial segments, a proximal one of the coaxial segments being connected to the distal region of the catheter, and the support member is configured such that when the support member expands from the contracted state to the expanded state, at least one of the segments slides from the proximal segment to the distal end.

[0035] In one application, the distal segment is fixedly connected to the capsule.

[0036] In one application, the plurality of coaxial segments includes at least 2 segments.

[0037] In one application, the plurality of coaxial segments includes less than 15 segments.

[0038] In one application, the plurality of coaxial segments includes 2-15 segments.

[0039] In one application, at least two of the segments have a radial thickness of 0.05-0.5 mm.

[0040] In one application, at least two of the segments have a length of 3-15 mm.

[0041] In one application, the support member is configured such that when the support member expands from the contracted state to the expanded state, a first adjacent to a second of the segments slides distally 2 mm to 14 mm relative to the second of the segments along the distal portion axis.

[0042] In one application, each of the segments longitudinally overlaps with at least one other of the segments, and when the support member is in the expanded state, at least two of the segments longitudinally overlap to a lesser extent than when the support member is in the contracted state.

[0043] In one application, when the support member is in the expanded state, the diameter of the most distal segment is 2-10 mm larger than the diameter of the proximal segment.

[0044] In one application, when the support member is in the expanded state, the maximum dimension of the most distal segment perpendicular to the axis of the distal portion is 2-10 mm larger than the maximum dimension of the proximal segment perpendicular to the axis of the distal portion.

[0045] The present invention may be more fully understood through the following detailed description of its application in conjunction with the accompanying drawings, in which:

[0046] Brief description of the accompanying drawings

[0047] Figure 1A - B is a schematic diagram of a catheter support for use with a catheter according to some applications of the present invention; and

[0048] Figure 2A - B is a schematic diagram of the use of the distal portion of a delivery tool according to some applications of the present invention. DETAILED DESCRIPTION

[0049] Reference Figure 1A -B, which is a schematic diagram showing a catheter support 300 according to some applications of the present invention used with catheter 132. Support 300 can be used with other catheters.

[0050] As shown in the figure, the support member 300 has a retracted state ( Figure 1A ) and expansion state ( Figure 1B ).like Figure 1B As shown, the support member is formed to define a support member cavity 308 and is generally used to mechanically support components located within and outside the support member cavity. For clarity, Figure 1A -B shows the support 300 without elements disposed within the support lumen 308 .

[0051] The support member 300 is fixedly connected to the distal region 136 of the catheter 132, and it is generally desired that the support member has a limited profile when in a contracted state so that the contracted support member adds as little volume to the catheter as possible. For some applications, when the support member 300 is in a contracted state, the support member has a radial thickness d320 between 1 mm and 3 mm.

[0052] It is also generally desirable that the support member 300 has a limited length when in a contracted state. For some applications, as shown, the support member 300 includes a plurality of coaxial segments 302 nested relative to each other. Typically for such applications, the support member 300 has at least two segments. For example, the support member 300 may have less than 15 segments, such as 2-15 segments. Typically each segment 302 is sized to have a limited length d330 (e.g., between 4mm and 18mm) and a radial thickness d324 (e.g., between 0.05mm and 0.5mm), thereby reducing the overall length and thickness of the support member 300 when the support member contracts.

[0053] When the support member 300 is contracted ( Figure 1A ), the segments 302 generally overlap longitudinally, further reducing the overall length d322a of the support when the support is contracted. Typically for such applications, the support 300 is expanded by reducing the longitudinal overlap between the segments 302, for example, at least some of the segments 302 are longitudinally moved relative to other segments 302 to expand the support 300.

[0054] For some applications, support member 300 has an expanded length d322b that is two to five times the contracted length d322a. Figure 1B For example, the support member 300 can be expanded to a length greater than the contracted length d322a ( Figure 1A ) is 10 to 60 mm long (e.g., 10 to 50 mm long).

[0055] For some applications, in order to expand the support member 300, at least one segment slides from the proximal segment 302a to the distal end. For example, as shown in the figure, the segment 302 moves distally relative to the segment with a smaller diameter. Since each segment 302 that gradually approaches the distal end has a larger diameter than the adjacent proximal segment, the support member 300 gradually tapers toward the proximal end in the expanded state. For some such applications, when the support member is in the expanded state, the diameter of the distal segment 302b is 2-10mm larger than the diameter of the proximal segment 302a.

[0056] For some applications, support member 300 self-expands from a contracted state to an expanded state without the application of an external force, for example, due to a spring 310 disposed within support member 300 being compressed when support member 300 is in the contracted state. Typically for such applications, as shown, spring 310 occupies only a portion of support member lumen 308, such that the unoccupied space remaining within the support member lumen serves as a passage for elements mechanically supported by support member 300. Typically, a proximal portion 312 of the spring contacts a distal region 136 (e.g., distal end 138) of catheter 132, and a distal portion 314 of the spring contacts a distal portion 304 of the support member. For some applications, such as Figure 1A As shown in the inset of FIG. 3 , the proximal segment 302a is formed to define a recess in which a portion of the spring 310 is disposed.

[0057] For some such applications, as shown, the self-expansion of support member 300 is limited so that the support member does not expand beyond the expanded length. Figure 1B As shown in the circular inset of , each pair of segments 302 can be complementarily shaped to define a step 316. As the segments 302 gradually slide distally, each continuous segment 302 is pulled distally until the steps 316 corresponding to each pair of segments abut against each other at the interface 306, thereby limiting further longitudinal expansion of the support member 300.

[0058] Reference Figure 2A -B, a schematic diagram showing the use of the distal portion 1024' of a delivery tool according to some applications of the present invention.

[0059] exist Figure 2A -B, the distal portion 1024' is shown for delivering an implant 20 (e.g., a prosthetic valve) at the mitral valve. The capsule assembly 1063 is shown as being delivered to the mitral valve using the first catheter 122 and the second catheter 132 of the steerable catheter system. This non-limiting example is not meant to exclude the use of other steerable catheter systems in conjunction with the above Figure 1A - Possibility of combining the devices described in B with appropriate modifications.

[0060] Figure 2A It is shown at a deployment stage where the plurality of flanges 54 have been deployed within the atrium 6 for delivery of the implant 20 to the distal portion 1024' of the mitral valve. Figure 2AThe cross-sectional view of shows the shaft 1034 extending from within the catheter lumen 133 of the catheter 132, through the support 300, and to the mounting member 1028. Typically, at least a portion of the shaft 1034 has greater flexibility than the catheter 132. Although the flexibility of the shaft 1034 may be advantageous when the shaft is guided through the confines of the vascular system, additional rigidity may be required when the capsule assembly 1063 is advanced into the ventricle 8. That is, when the capsule assembly 1063 encounters mechanical forces while advancing through the mitral valve, the flexibility of the shaft 1034 can allow the capsule assembly to be directed. As described below, the support 300 is configured to reduce the likelihood that such mechanical forces will change the direction of the capsule assembly 1063.

[0061] exist Figure 2A In the right illustration of FIG. 3 , the support member 300 is in a retracted state, and the distal portion 304 of the support member 300 is shown adjacent to the proximal capsule 1064 of the capsule assembly 1063. When the support member 300 is in a retracted state, the spring 310 is compressed so that it applies a thrust to the proximal capsule 1064. The operator adjusts the advancement of the capsule assembly 1063 toward the distal end by controlling the shaft 1034 that cooperates with the capsule assembly to move forward.

[0062] Figure 2B The implant 20 is shown in a deployed stage positioned at the mitral valve, wherein the capsule assembly is advanced distally through the mitral valve, e.g., during ventricular systole, until the leaflets 12 of the native valve 10 are determined to coapt upstream of the flange 54. Figure 2B As shown, the capsule assembly 1063 is advanced distally along the distal portion axis d1024 by advancing the shaft 1034 distally, allowing the support member 300 to self-expand to an expanded state. Since the support member 300 has a greater stiffness than the shaft 1034, the expanded support member provides mechanical support to the supported portion 1034s of the shaft 1034 located in the support member lumen 308, thereby stabilizing the capsule assembly and / or implant 20 disposed at the distal end of the support lumen 308. For some applications, as shown, when the support member is in the expanded state, the support member 300 (e.g., its distal portion 304) continues to extend to the capsule assembly 1063. For some such applications, the support member 300 (e.g., its distal segment 302b) is fixedly connected to the capsule assembly 1063 (e.g., connected to the proximal capsule 1064).

[0063] In this manner, after the capsule assembly is properly oriented, the support member 300 can reduce the effects of mechanical forces that the capsule assembly 1063 may encounter when passing through the mitral valve, facilitating the placement of the flange 54 downstream of the leaflet, such as Figure 2B shown.

[0064] Subsequently, the capsule assembly 1063 is typically retracted proximally relative to the catheter 132 (e.g., along the distal portion axis d1024) until it is determined that the flange 54 has engaged the leaflet 12. Typically for such applications, the proximal movement of the capsule assembly 1063 causes the support 300 to at least partially contract from the expanded state to the contracted state, for example, by the proximal capsule 1064 pushing the distal portion 304 of the support proximally. That is, the support 300 typically does not include a locking mechanism that prevents the capsule assembly from moving proximally to allow the support to contract. After the capsule assembly 1063 has been partially retracted as described, the proximal capsule 1064 is typically retracted proximally relative to the shaft 1034, thereby exposing the implant.

[0065] For some applications, the proximal capsule 1064 is retracted proximally by applying a rotational force to the proximal end of the shaft 1034 or the proximal end of other longitudinal members that engage the engagement disk assembly 1086. The engagement disk assembly 1086 is typically adapted within the proximal capsule 1064 and includes a proximal disk that is rotationally connected to the distal disk and can be rotationally moved relative to the distal disk. Typically further, the exterior of the proximal disk is defined with external threads that are complementary to the internal threads defined on the interior of the proximal capsule 1064. Further for such applications, the proximal capsule 1064 is formed to define one or more longitudinal tracks 1088 that pass through the internal threads. Because the proximal disk is fixedly connected to the capsule catheter, rotation of the capsule catheter relative to the shaft 1034 causes the proximal disk to be screwed along the internal threads of the proximal capsule 1064. At the same time, the distal disk is prevented from rotating because the distal disk: (i) is fixedly connected to the shaft 1034, and (2) cooperates with the track 1088 of the proximal capsule 1064. Thus, screwing the proximal disk can push the distal disk along the track 1088, thereby converting the rotation of the proximal disk into axial movement of the proximal capsule 1064 relative to the engagement disk assembly 1086 and the mounting member 1028. Finally, the distal capsule 1066 is advanced distally to further expose the implant and the mounting member 1028, and then the distal portion 1024' is withdrawn from the object. Further details about this technology are described with reference to FIG. 14D of U.S. Provisional Patent Application 63 / 350,200 to Albitov et al., and with appropriate modifications, which is incorporated herein by reference.

[0066] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above. On the contrary, the scope of the present invention includes the combination and sub-combination of the various features described above, as well as variations and modifications thereof that do not exist in the prior art that those skilled in the art will think of when reading the above description.

Claims

1. A device for use with a subject's heart, the device comprising: A delivery vehicle sized and configured for percutaneous delivery of an implant to a heart, the delivery vehicle comprising: a catheter, defining a catheter lumen, a shaft, at least a portion of which is slidably disposed within the lumen of the catheter, and a distal portion defining a distal portion axis and comprising: A capsule comprising: configured to receive at least a portion of the implant, connected to the distal portion of the shaft, and slidable relative to the catheter along the distal portion axis to switch the capsule from a first state at a first distance from the distal end of the catheter to a second state at a second distance from the distal end of the catheter, wherein the second distance is greater than the first distance; and A support member, wherein: fixedly connected to the distal end region of the catheter, extending along the distal portion axis from the distal end of the catheter toward the capsule, and The capsule is configured to expand when the capsule switches from the first state to the second state: from a contracted state in which the support has a first length to an expanded state in which the support has a second length.

2. The device according to claim 1, characterized in that: The proximal region of the support is fixedly connected to the distal region of the catheter.

3. The device according to claim 1, characterized in that: The support member is configured to define a support member lumen, and a portion of the shaft is disposed within the support member lumen, wherein when the support member is in the expanded state, the stiffness of the support member is greater than the stiffness of the portion of the shaft.

4. The device according to claim 1, characterized in that: The support is configured such that when the capsule switches from the first state to the second state, the support self-expands from a contracted state to the expanded state.

5. The device according to claim 1, characterized in that: The capsule is reversibly slidable relative to the catheter along the distal portion axis so that the capsule can switch from the second state to the first state, The support member is configured to contract from the expanded state to the contracted state when the capsule switches from the second state to the first state.

6. The device according to claim 1, characterized in that: When the support member is in the contracted state, the support member has a radial thickness of 1-3 mm.

7. The device according to claim 1, characterized in that: When the support member is in the contracted state, the support member has a length of 4-18 mm.

8. The device according to claim 1, characterized in that: When the support member is in the expanded state, the support member has an expanded length between 10 mm and 60 mm.

9. The device according to any one of claims 1 to 8, characterized in that: When the support member is in the contracted state, the support member has a contracted length, and an expanded length is 10-50 mm longer than the contracted length.

10. The device according to claim 8, characterized in that: When the support member is in the contracted state, the support member has a contracted length, and the expanded length is 2 to 5 times the contracted length.

11. The device according to any one of claims 1 to 8, characterized in that: The support is configured such that when the support is in the expanded state, the support extends from the distal end of the catheter to the capsule.

12. The device according to claim 11, characterized in that: The support is configured such that when the support expands from the contracted state to the expanded state, the support extends from the distal end of the catheter to the capsule.

13. The device according to any one of claims 1 to 8, characterized in that: The support member includes a plurality of coaxial segments, a proximal one of the coaxial segments being connected to the distal region of the catheter, and the support member is configured such that at least one of the segments slides from the proximal segment to the distal end when the support member expands from the contracted state to the expanded state.

14. The device according to claim 13, characterized in that: The distal segment is fixedly connected to the capsule.

15. The device according to claim 13, characterized in that: The plurality of coaxial segments comprises at least 2 segments.

16. The device according to claim 13, characterized in that: The plurality of coaxial segments includes less than 15 segments.

17. The device according to claim 13, characterized in that: The plurality of coaxial segments comprises 2-15 segments.

18. The device according to claim 13, characterized in that: At least two of the segments have a radial thickness of 0.05-0.5 mm.

19. The device according to claim 13, characterized in that: At least two of the segments have a length of 3-15 mm.

20. The device according to claim 13, characterized in that: The support member is configured such that a first of the segments adjacent to a second of the segments slides distally by 2 mm to 14 mm relative to the second of the segments along the distal portion axis when the support member expands from the contracted state to the expanded state.

21. The device according to claim 13, characterized in that: Each of the segments longitudinally overlaps with at least one other of the segments, and at least two of the segments longitudinally overlap to a lesser extent when the support member is in the expanded state than when the support member is in the contracted state.

22. The device according to claim 21, characterized in that: When the support member is in the expanded state, the diameter of the most distal segment is 2-10 mm larger than the diameter of the proximal segment.

23. The device according to claim 21, characterized in that: When the support member is in the expanded state, the maximum dimension of the most distal segment perpendicular to the axis of the distal portion is 2-10 mm larger than the maximum dimension of the proximal segment perpendicular to the axis of the distal portion.

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