Methods and systems for reducing limb ischemia
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- ABIOMED INC
- Filing Date
- 2023-05-10
- Publication Date
- 2026-05-15
AI Technical Summary
Limb ischemia is a significant risk for patients using mechanical circulatory assist devices, resulting from interruption of blood flow, local occlusions, and issues with closure, which can lead to adverse outcomes and complications.
A device with a radially expandable feature, comprising one or more metal wires around a tubular member, which can be selectively expanded to increase the diameter of a blood vessel, allowing blood to flow around and through the device, thereby reducing the risk of limb ischemia.
The expandable device effectively promotes blood perfusion to distal limbs, reduces the risk of limb ischemia, and minimizes complications such as infection and pseudoaneurysm by maintaining blood flow without completely occluding the vessel.
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Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications
[0001] This application claims the benefit of U.S. Patent Application No. 63 / 340,344, filed May 10, 2022, which is hereby incorporated by reference in its entirety.
[0002] Technical Field
[0002] The present disclosure relates to methods, devices, and systems for use in preventing and / or reducing limb ischemia such as may result from the use of mechanical circulatory assist devices.
Background Art
[0003] Background
[0003] Limb ischemia is a rapid and sudden decrease in perfusion of the limbs and often threatens the viability of the limbs. This can occur as a result of interruption of blood flow by an indwelling sheath and / or catheter, local occlusion (e.g., atherosclerotic stenosis), and / or persistent occlusion due to small blood vessels and / or large sheaths. This can also occur as a result of problems with closure.
[0004]
[0004] Limb ischemia is associated with mortality, and some literature has shown that the incidence of limb ischemia can be high. Thus, limb ischemia can have an adverse effect on patients in addition to having an adverse effect on ongoing clinical trials.
Summary of the Invention
Means for Solving the Problems
[0005] Summary
[0005] In various aspects, a device may be provided. The device may include a first tubular member. The device has a radially expandable feature having one or more metal wires disposed around the first tubular member, and is selectively expandable from a first configuration to a second configuration such that blood within a patient's blood vessel flows from a location upstream of the radially expandable feature around the first tubular member, around and / or through the one or more radially expandable features, to a location downstream of the radially expandable feature. The device may include a radially expandable feature configured as such.
[0006]
[0006] The one or more metal wires may form a cylindrical wire mesh around the first tubular member. The wire mesh may have a first configuration. The first configuration may have an outer diameter of 12 Fr or less. The wire mesh may have a second configuration. The second configuration may have an outer diameter of 20 Fr or more. The wire mesh may be configured to have a controllable outer diameter, which may be between 7 Fr and 23 Fr. When compressed in the second configuration, the wire mesh may increase its outer diameter and decrease its axial length. When tensioned in the first configuration, the wire mesh may decrease its outer diameter and increase its axial length.
[0007]
[0007] The one or more metal wires may form a stent around the first tubular member. That is, the stent may be a radially expandable feature. The one or more metal wires form a wire basket around the first tubular member.
[0008]
[0008] The one or more metal wires may extend radially outward away from the first tubular member and be configured to expand a portion of the blood vessel.
[0009]
[0009] The device may include a second tubular member, and the first tubular member may be slidably received by the second tubular member. One or more metal wires may be coupled to the first tubular member. One or more metal wires may be coupled to the second tubular member. In some embodiments, the distal end of the second tubular member may be configured to contact the proximal end of one or more wires, such that compressing one or more wires may require moving the second tubular member in the distal direction. In some embodiments, the distal end of the second tubular member may be configured to contact the distal end of one or more wires, such that compressing one or more wires may require moving the second tubular member in the proximal direction. The distal end of the second tubular member may have one or more protrusions. The one or more protrusions may have at least one surface configured to contact the distal end of one or more wires.
[0010]
[0010] In various aspects, a method of reducing the risk of limb ischemia may be provided. The method may include inserting a device as disclosed herein into a blood vessel (such as an artery). The method may include expanding a blood vessel at a location by expanding an expandable feature to a second configuration. The method may include enabling blood to pass from a location upstream of one or more wires through the one or more wires to a location downstream of the one or more wires. The method may include returning the expandable feature to a first configuration. The method may include removing the device from the blood vessel.
[0011]
[0011] In some embodiments, the method may include inserting a cannula through the first tubular member before the device is inserted into the blood vessel. In some embodiments, the method may include inserting a mechanical circulatory assist device through the first tubular member after the device is inserted into the blood vessel.
[0012]
[0012] This method may include sliding a second tubular member over a first tubular member. The distal end of the second tubular member may contact the proximal end of one or more wires, and the method may include compressing the one or more wires by moving the second tubular member distally. The distal end of the second tubular member may contact the distal end of one or more wires, and the method may include compressing the one or more wires by moving the second tubular member proximally.
[0013] Brief Description of the Drawings
[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention above and the detailed description of the embodiments below, serve to explain the principles of the invention.
Brief Description of the Drawings
[0014]
Figure 1A
[0014] Includes a diagram of a device having an expandable feature in a first configuration.
Figure 1B
[0014] Includes a diagram of a device having an expandable feature in a second configuration.
Figure 2A
[0015] A diagram of an expandable feature having one or more wires in a first configuration.
Figure 2B
[0016] A diagram of an expandable feature having one or more wires in a different second configuration.
Figure 2C
[0016] A diagram of an expandable feature having one or more wires in a different second configuration.
Figure 3
[0017] Diagrams of various embodiments of the device.
Figure 4
[0017] Diagrams of various embodiments of the device.
Figure 5
[0017] Diagrams of various embodiments of the device.
Figure 6
[0018] A diagram of the device in a second configuration within a blood vessel.
Figure 7
[0019] It is a diagram of a device within a patient.
Figure 8
[0020] It is a flowchart of a method.
Best Mode for Carrying Out the Invention
[0015] Detailed Description
[0021] The following description and drawings merely illustrate the principles of the present invention. Accordingly, those skilled in the art will understand that they can devise various configurations that embody the principles of the present invention and are included within its scope even if not explicitly described or illustrated herein. Furthermore, all examples described herein are explicitly intended solely for the exemplary purpose of assisting the reader in understanding the principles of the present invention and the concepts contributed by the inventor to the art, and should not be construed as being limited to such specifically described examples and conditions. In addition, the term "or" as used herein refers to a non-exclusive "or" unless otherwise indicated (e.g., "or otherwise" or "or alternatively"). Also, the various embodiments described herein are not necessarily mutually exclusive, and some embodiments may be combined with one or more other embodiments to form new embodiments.
[0016]
[0022] Many innovative teachings of this application will be described with particular reference to presently preferred exemplary embodiments. However, it should be understood that such embodiments merely provide a few examples of many advantageous uses of the innovative teachings herein. Generally, the descriptions made in the specification of this application do not necessarily limit any of the various claimed inventions of the present invention. Furthermore, some descriptions may apply to some features of the inventions but may not apply to other features. Based on the teachings herein, those skilled in the art will understand that the present invention is applicable to various other technical fields or embodiments.
[0017]
[0023] As is well known, limb ischemia is a rapid and sudden reduction in perfusion of a patient's limbs, which can occur due to interruption of blood flow by an indwelling sheath and / or catheter, local occlusion (e.g., atherosclerotic stenosis), and / or persistent occlusion resulting from small blood vessels and / or large sheaths. Limb ischemia can result from the use of closure devices.
[0018]
[0024] In some cases, to address limb ischemia, a small-diameter catheter can be inserted distally to provide antegrade blood flow to the ischemic limb. For example, the catheter can be inserted into either the dorsalis pedis artery or the posterior tibial artery. As will be appreciated, antegrade blood flow can be introduced at any suitable time (e.g., at the time of initial ECMO cannula insertion, or at the time of implantation of a mechanical circulatory support device, or at a later time such as after ischemia is detected). In some cases, this conventional solution may not be available to all patients. For example, some patients may not have a dorsalis pedis artery or a posterior tibial artery large enough to introduce a catheter.
[0019]
[0025] The inventors recognized that if ischemic events are rapidly identified and addressed, improvement in patient outcomes can be achieved. The inventors also recognized the advantage of promoting and providing perfusion to the distal limbs by expanding the vasculature around at least a portion of a device (e.g., an arterial ECMO cannula or an introducer sheath) in patients in whom an artery can be occluded via the device (e.g., an introducer sheath). For example, as described herein, by expanding the vasculature around at least a portion of a fully inserted cannula, blood flow (e.g., retrograde blood flow) can be made to travel around and through the cannula. In this regard, the devices and methods of the present disclosure can address unmet needs of currently existing distal limb perfusion techniques. The devices and methods of the present disclosure can also reduce the number of insertion sites in a patient, thereby reducing the risk of infection, sepsis, bleeding, hematoma, ischemia, and / or pseudoaneurysm.
[0020]
[0026] In various aspects, devices and methods can be provided for promoting and providing perfusion of the distal extremities and reducing limb ischemia. Referring to FIG. 1A, a device 100 according to some embodiments can include a tubular member 110. The first tubular portion can be, for example, a sheath, cannula, catheter, or the like. The tubular member can include a lumen 112 that extends therethrough (e.g., from the distal end to the proximal end). The tubular member can be constructed from any suitable material such as nitinol, a medical grade polymer (such as polyurethane), combinations thereof, or other suitable materials. As will be appreciated, one or more medical devices (e.g., a mechanical circulatory assist device) can be passed through the lumen 112.
[0021]
[0027] As described herein, the device can be configured to expand the vasculature surrounding the device. Thus, in some embodiments, the device can include an expandable feature disposed around at least a portion of the tubular member 110. In some embodiments, the expandable feature can include one or more metal wires 120 disposed around the first tubular member, such as at or near the distal end of the tubular member. In some embodiments, one or more wires can form part of, or be part of, an expandable wire mesh. In other embodiments, one or more wires can form part of, or be part of, an expandable stent. The metal wire can be nitinol, stainless steel, or another suitable material.
[0022]
[0028] In some embodiments, the device can include an additional tubular member 130 configured to slidably receive the tubular member 110.
[0023]
[0029] As described herein, the expandable feature may have a first folded configuration, such as when the tubular member is inserted into a patient's vasculature (see FIG. 1A). As shown, in this configuration, one or more wires of the expandable feature may have a relatively small outer diameter that is only slightly larger than the outer diameter of the tubular member 110. In some embodiments, this may be the default configuration. In some embodiments, this configuration may exist when one or more wires of the expandable feature are tensioned. In some embodiments, the first configuration may have an outer diameter of 12Fr or less, although it will be understood that other diameters may be used.
[0024]
[0030] As will be appreciated, in addition to insertion, the first configuration may be useful when the device is repositioned within the blood vessel 10 and / or removed from the blood vessel 10. In this regard, the expandable feature may transition from the first folded configuration to a second expanded configuration and then back to the first configuration. In some embodiments, the blood vessel may be an artery, such as the femoral artery.
[0025]
[0031] The expandable feature (e.g., one or more wires) may also have a second expanded configuration, as shown in FIG. 1B, to expand the vasculature and create a path for blood flow around the tubular member 110. In some embodiments, in the expanded configuration, one or more wires 120 may be axially compressed, and one or more wires may have an outer diameter 123 that is relatively larger (and larger than the tubular member 110) than the outer diameter in the first configuration. In the expanded configuration, one or more wires may also have an axial length 125 that is relatively shorter than the axial length of the wires in the first configuration. In some embodiments, the expanded configuration may also be a default configuration having a compressible feature to return to the compressed configuration. In some embodiments, this configuration may exist when one or more wires are compressed. The second configuration may have an outer diameter of 20Fr or more. In some embodiments, the second configuration may have a controllable outer diameter that can be adjusted to any predetermined diameter from its minimum diameter (such as 7Fr) to its maximum diameter (such as 23Fr).
[0026]
[0032] As shown, one or more metal wires may be configured to extend radially outwardly away from the central axis 114 of the tubular member 110 and away from the tubular member 110 toward the blood vessel 10 to expand a portion of the blood vessel.
[0027]
[0033] FIG. 2A shows an embodiment in which the expandable feature includes one or more wires forming a wire mesh. As shown in this figure, the wire mesh 120 in the first folded configuration may have an outer diameter 122 and an axial length 124. Referring to FIG. 2B, in the expanded state upon compression, the wire mesh may increase its outer diameter 122 and decrease its axial length 124. In some embodiments, the wire mesh may form a stent around the tubular member 110, whereby one or more wires are compressed against the blood vessel and most of the blood is configured to flow into a central lumen 128 defined by the one or more wires through one or more ends of the wire mesh. Blood can also flow through the mesh. As will be appreciated, when tension is reapplied, the wire mesh may decrease its outer diameter and increase its axial length to return to the configuration shown in FIG. 2A.
[0028]
[0034] As shown in FIGS. 2A and 2B, the expandable feature may have a constant (or substantially constant) diameter in each of the first and second configurations. In other embodiments, the shape of the mesh (or stent) may vary, for example, between the distal end and the proximal end.
[0029]
[0035] For example, referring to FIG. 2C, in some embodiments, upon compression, the wire mesh may have a distal portion 126 having a first outer diameter 122 and a more proximal portion 127 having a second outer diameter 123 that is larger than the first outer diameter.
[0030]
[0036] In some embodiments, the wire mesh may form a wire basket around the tubular member 110, such that blood enters the central lumen defined by the one or more wires by passing through the gaps 129 between the one or more wires at a position remote from the two ends of the wire mesh.
[0031]
[0037] As will be appreciated, the wires may form a stent or wire basket having openings of any suitable shape. For example, in some embodiments, the openings may be diamond-shaped, square, triangular, other polygonal, or other suitable shapes. The wires may have any suitable thickness, although it will be understood that the wires are strong enough to maintain the blood vessel in a distended state when the expandable feature is in the expanded configuration.
[0032]
[0038] As disclosed herein, one or more metal wires 120 of the expandable feature may be coupled to the tubular member 110. For example, as shown in FIG. 3, one or more metal wires may be coupled at the distal ends 161 of the one or more wires. The one or more wires may have one or more attachment points 140 for coupling the expandable feature to the tubular member 110. In some embodiments, the attachment points may include connectors, adhesives, welds, or other suitable attachment points. In FIG. 4, one or more metal wires of the expandable feature may also be coupled at one or more attachment points 140 at the proximal ends 162 of the one or more metal wires. Similarly, the same or different types of attachment points used at the proximal end may be used at the distal end.
[0033]
[0039] One or more metal wires 120 of the expandable feature may be coupled to an additional tubular member 130, such as that described above with respect to the tubular member 110.
[0034]
[0040] In some embodiments, the distal end 131 of the additional tubular member 130 may be configured to contact the proximal ends 162 of one or more wires of the expandable feature, such that compressing the one or more wires may require moving the second tubular member in the distal direction 150.
[0035]
[0041] In some embodiments, the distal end 131 of the additional tubular member 130 can be configured to contact the distal end 161 of one or more wires, such that compressing the one or more wires may require moving the additional tubular member in the proximal direction 152. As will be appreciated, in some embodiments, the additional tubular member 130 can be used as an actuator for moving an expandable feature (e.g., a wire mesh) between a first configuration and a second configuration.
[0036]
[0042] Referring to FIG. 5, in still other embodiments, one or more wires of the expandable feature may not be coupled to the tubular member 110. Rather, as disclosed with respect to FIG. 4, the additional tubular member 130 can be configured to contact the distal ends of one or more wires. Additionally, a second additional tubular member 170 can be configured to contact the proximal ends of the one or more wires, such that when the additional tubular member 130 moves in the proximal direction 152, it compresses the one or more wires against the second additional tubular member 170. Similarly, in this regard as well, the additional tubular member can function as an actuator for moving the expandable feature between a first configuration and a second configuration.
[0037]
[0043] In some embodiments, the distal end 131 of the additional tubular member 130 can have one or more protrusions 132 that extend radially outward (e.g., away from the central axis of the tubular member 110). The one or more protrusions 132 can have at least one surface 134 configured to contact the distal end 161 of the one or more wires 120. As will be appreciated, in other embodiments, other connectors can also be used.
[0038]
[0044] As shown in FIG. 6, in some embodiments, the first tubular member 110 can be used to pass one or more medical devices therethrough, but can also be used to pass blood through a patient's vasculature. In this regard, blood can flow through the first tubular member 110 in a first direction (see arrow 182), while blood within the blood vessel can flow in the opposite direction (see arrow 180) through one or more wires from a position upstream of the one or more wires to a position downstream of the one or more wires. In this way, distal perfusion can be achieved by blood flow in the second direction (arrow 180).
[0039]
[0045] As understood from the above perspective, the expandable feature portion can be configured to move between a first configuration and a second configuration. In some embodiments, the expandable feature portion can be configured to automatically move between the first configuration and the second configuration, for example, in response to received information (such as the occurrence or likelihood of an ischemic event). In some embodiments, the expandable feature portion can be configured such that a clinician can selectively expand the expandable feature portion to an expandable state or return the expandable feature portion to a compressed state. Referring to FIG. 7, which shows the device 100 in a state where it is disposed within a blood vessel after passing through the insertion point 20 of the patient's skin 22, in some embodiments, the device can include one or more handles 700 operably coupled to the device. In such embodiments, the handle can be used, for example, to expand the expandable feature portion (such as opening a wire mesh or stent around a tubular member) to create space in the vasculature and provide a path for blood around the tubular member to control the device. As understood, the handle can be operably coupled to the expandable feature portion. In some embodiments, the handle can actuate an additional tubular member (such as an actuator) to expand the expandable feature portion. In some embodiments, the handle can be rotated to cause axial movement of the expandable feature portion. In some embodiments not shown, the handle can be connected to an inflatable member (such as a balloon) disposed between the tubular member and the expandable feature portion, and the inflatable member is configured to expand the wire to an expanded configuration. As understood, the wire, when expanded, can be configured to maintain the expanded shape up to the clinician.
[0040]
[0046] In various aspects, a method of reducing the risk of limb ischemia can be provided. Referring to FIG. 8, method 800 can include inserting 810 a device disclosed herein into a blood vessel (such as an artery). In some embodiments, the device may need to be inserted at an appropriate depth so as to expand the blood vessel (such as an artery) without expanding the arteriotomy / insertion site.
[0041]
[0047] The method may include expanding a blood vessel at a location by expanding one or more wires from a first configuration to a second configuration.
[0042]
[0048] For example, in some embodiments, during use, one or more wires first wrap around the outer diameter of a tubular member / cannula and then expand and are pressed against the wall of the arteriotomy to expand the blood vessel and leave a gap between the cannula and the blood vessel wall. The device may, during operation, prevent the cannula from completely occluding the blood vessel and allow blood flow around and through the cannula.
[0043]
[0049] The method may include enabling blood to pass from a location upstream of one or more wires through the one or more wires to a location downstream of the one or more wires. The method may include returning one or more wires to a first configuration.
[0044]
[0050] The method may include removing the device from the blood vessel, such as after the patient has been weaned from a medical device (e.g., arterial ECMO support or mechanical circulatory support). In such embodiments, the metal wire of the expandable feature (in the first configuration) may be removed together with the tubular member (e.g., cannula). In other embodiments, the cannula may be removed first and the expandable feature may be left in place and later removed by a physician.
[0045]
[0051] In some embodiments, the method may include inserting a cannula through a tubular member (such as tubular member 110) before the device is inserted into the blood vessel. In some embodiments, the method may include inserting a cannula through a tubular member after the device has been inserted into the blood vessel.
[0046]
[0052] The method may include sliding a second tubular member over a first tubular member. As disclosed herein, the distal end of the second tubular member may contact the proximal ends of one or more wires, and the method may include compressing the one or more wires by moving the second tubular member in a distal direction. The distal end of the second tubular member may contact the distal ends of the one or more wires, and the method may include compressing the one or more wires by moving the second tubular member in a proximal direction.
[0047]
[0053] With reference to the figures, which identify like or identical elements by like reference numerals, embodiments of the present disclosure are described in detail. It is to be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. To avoid obscuring the present disclosure with unnecessary detail, well-known functions or constructions are not described in detail. Thus, the specific structural and functional details disclosed herein are not to be construed as limiting, but only as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art how to make and use the present disclosure in substantially any appropriately detailed structure.
[0048]
[0054] Although various embodiments incorporating the teachings of the present invention are shown and described in detail herein, one of ordinary skill in the art can readily devise many other various embodiments that still incorporate these teachings. Accordingly, the foregoing is considered with respect to various embodiments of the present invention, but other and further embodiments of the present invention may be devised without departing from its basic scope.
Claims
1. A first tubular member and A radially expandable feature having one or more metal wires arranged around the first tubular member, wherein the radially expandable feature is selectively expanded from a first configuration to a second configuration, and is configured to allow blood in a patient's blood vessels to flow around the first tubular member from an upstream point of the radially expandable feature to a downstream point of the radially expandable feature, around and / or through one or more of the radially expandable feature. A device that includes this.
2. The device according to claim 1, wherein the one or more metal wires form a cylindrical wire mesh around the first tubular member.
3. The device according to claim 2, wherein the wire mesh has an outer diameter of 12 Fr or less in the first configuration.
4. The device according to claim 1, wherein the wire mesh has an outer diameter of 20 Fr or more in the second configuration.
5. The device according to claim 1, wherein the wire mesh may be configured to have an outer diameter of 7 Fr to 23 Fr.
6. The device according to claim 1, wherein, in the second configuration, the wire mesh increases its outer diameter and decreases its axial length during compression, and in the first configuration, the wire mesh decreases its outer diameter and increases its axial length during tension.
7. The device according to claim 1, wherein the one or more metal wires form a stent or wire basket around the first tubular member.
8. The device according to claim 1, wherein one or more metal wires extend radially outward away from the first tubular member and are configured to dilate a portion of a blood vessel.
9. The device according to claim 1, further comprising a second tubular member, wherein the first tubular member is slidably received by the second tubular member.
10. The device according to claim 9, wherein one or more metal wires are coupled to the first tubular member.
11. The device according to claim 9, wherein one or more metal wires are coupled to the second tubular member.
12. The distal end of the second tubular member is configured to contact the proximal end of the one or more metal wires, so that compressing the one or more metal wires requires moving the second tubular member distally, or The distal end of the second tubular member is configured to contact the distal end of one or more metal wires, so that compressing the one or more metal wires requires moving the second tubular member in the proximal direction, or The device according to claim 9, wherein the distal end of the second tubular member has one or more protrusions, and each of the one or more protrusions has at least one surface configured to contact the distal end of the one or more metal wires.
13. Inserting the device described in claim 1 into a blood vessel, By extending the radially expandable feature portion to the second configuration, the blood vessel is expanded at a certain position, To enable blood to pass from an upstream position of the one or more metal wires through the one or more metal wires to a downstream position of the one or more metal wires. A method that includes this.
14. Returning the one or more metal wires to the first configuration, Removing the device from the blood vessel The method according to claim 13, further comprising:
15. The procedure further includes inserting a mechanical circulatory support device through the first tubular member after the device has been inserted into the blood vessel, or The method according to claim 13, further comprising inserting a cannula through the first tubular member after the device has been inserted into the blood vessel.
16. The method according to claim 13, further comprising sliding a second tubular member on the first tubular member.
17. The distal end of the second tubular member is in contact with the proximal end of the one or more metal wires, and compressing the one or more metal wires requires moving the second tubular member distally, or The method according to claim 16, wherein the distal end of the second tubular member is in contact with the distal end of one or more metal wires, and compressing the one or more metal wires requires moving the second tubular member in the proximal direction.