Mechanical circulatory support system with repositionable sheath

Abstract

A mechanical circulatory support system can include a blood pump, a housing, an elongated shaft, a first sheath, and a second sheath. The blood pump can pump blood from a chamber of a patient's heart to the patient's vasculature. The elongated shaft can be coupled with the blood pump and extend proximally from the blood pump to the housing. The first sheath can have a first hub and a lumen with an inner diameter. The second sheath can have a second hub and an outer diameter that is less than the inner diameter of the lumen. The first sheath and the second sheath can be longitudinally advanced over the elongated shaft, and a distal end of the second sheath can be advanced through the lumen and extend distally beyond a distal end of the first sheath.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 591,819, filed October 20, 2023, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This invention relates to a sheath configuration for a mechanical circulatory support system. More particularly, this invention relates to a repositioning sheath for a mechanical circulatory support system at a vascular access site. Background Technology

[0003] In various procedures for delivering endovascular medical devices, an inserter sheath is inserted into a patient's blood vessel, such as the femoral artery, and one or more medical devices can be advanced through the sheath into the patient's vascular system. In various cases, the medical device includes a catheter or other device, such as a blood pump. These devices and systems are manufactured using any of a wide variety of different methods and can be used according to any of these methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is currently a need to provide alternative medical devices and systems, as well as alternative methods for manufacturing and using these medical devices and systems. Summary of the Invention

[0004] This invention provides designs, materials, manufacturing methods, and alternative uses for medical devices, including percutaneous blood pumps and associated devices.

[0005] A first example may include a mechanical circulatory support system comprising a blood pump configured to pump blood from the ventricles of a patient's heart to the patient's vascular system; a housing; an elongated shaft coupled to and extending proximally from the blood pump to the housing; a first sheath having a first hub and a lumen with an inner diameter; and a second sheath having a second hub and an outer diameter smaller than the inner diameter of the lumen, wherein the first and second sheaths are configured to advance longitudinally along the elongated shaft, and a distal end of the second sheath is configured to advance through the lumen of the first sheath and extend distally beyond the distal end of the first sheath.

[0006] Alternatively or additionally for any of the above examples, the first sheath may be an introductory sheath configured to allow the blood pump to pass through the lumen.

[0007] Alternatively or additionally for any of the examples above, the second sheath may be a double-lumen sheath.

[0008] Alternatively or additionally for any of the above examples, a double-lumen sheath may include a first tube defining a first lumen, a second tube extending along the first tube and defining a second lumen, and a third tube extending over the first and second tubes.

[0009] Alternatively or additionally for any of the above examples, the system may also include a wire, and the dual-cavity sheath may define a first cavity configured to receive an elongated shaft and a second cavity configured to receive the wire.

[0010] Alternatively or additionally for any of the examples above, the second sheath may include an internal hemostatic valve.

[0011] Alternatively or additionally for any of the above examples, the first hub may be configured to engage with the second hub when the distal end of the second sheath is located distal to the distal end of the first sheath.

[0012] Alternatively or additionally for any of the above examples, the first hub may include a stitching pad configured to be disassembled from the first hub and slid on the first sheath to a position around the second sheath when the distal end of the second sheath is located distal to the distal end of the first sheath.

[0013] Alternatively or additionally for any of the above examples, the system may also include a clip configured to engage the suture pad with the second sheath when the suture pad is positioned around the second sheath.

[0014] Alternatively or additionally for any of the above examples, the second hub may include an adjustable shaft lock configured to releasably secure the second hub relative to the elongated shaft.

[0015] In another example, a method of adjusting a tubular assembly for a mechanical circulatory support system may include advancing a blood pump and an elongated shaft extending proximally from the blood pump through a first sheath; advancing a distal end of a second sheath on the elongated shaft and advancing it through the distal end of the first sheath to a position distal to the distal end of the first sheath; and connecting a first hub of the first sheath to a second hub of the second sheath.

[0016] Alternatively or additionally for any of the above examples, the method may also include removing the suture pad from the first hub; and positioning the suture pad at a location distal to the distal end of the first sheath, around the second sheath.

[0017] Alternatively or additionally for any of the above examples, the method may also include using a clip to connect the suture pad to the second sheath.

[0018] Alternatively or additionally for any of the examples above, the method may also include locking the second sheath to the elongated shaft.

[0019] Alternatively or additionally for any of the above examples, the method may also include adjusting the position of the blood pump by means of a sleeve engaging an elongated shaft connected to the second hub and an elongated shaft advancing relative to the second sheath.

[0020] Alternatively or additionally for any of the above examples, advancing the distal end of the second sheath may include advancing the distal end of the second sheath to a position distal to the patient access site.

[0021] Alternatively or additionally for any of the above examples, the method may also include withdrawing the distal end of the first sheath from the access site when the distal end of the second sheath is located distal to the patient access site.

[0022] Alternatively or additionally for any of the above examples, withdrawing the distal end of the first sheath from the passage portion may include advancing the first hub toward the second hub on the second sheath for engagement with the second hub.

[0023] In another example, a mechanical circulatory support system may include a blood pump configured to pump blood from the ventricles of a patient's heart to the patient's vascular system; an elongated shaft coupled to and extending proximally from the blood pump; an inlet sheath having a first hub and configured to extend along the elongated shaft, the inlet sheath having a lumen with an inner diameter configured to receive the blood pump; and a repositioning sheath having a second hub and configured to extend along the elongated shaft, the repositioning sheath having an outer diameter smaller than the inner diameter and a length longer than the length of the inlet sheath, wherein the first hub may be configured to engage with the second hub when the distal end of the repositioning sheath is distal to the distal end of the inlet sheath.

[0024] Alternatively or additionally for any of the above examples, the first hub may include a removable suture pad configured to slide on the inlet sheath to a position around the repositioning sheath when the distal end of the repositioning sheath is located distal to the distal end of the inlet sheath.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of the invention. The following drawings and detailed description illustrate some of these embodiments in more particular detail. Attached Figure Description

[0026] The invention will be more fully understood by taking into consideration the following detailed description in conjunction with the accompanying drawings, wherein:

[0027] Figure 1 It is a schematic three-dimensional diagram of an illustrative catheter system including a percutaneous blood pump;

[0028] Figure 2 This is a schematic cross-sectional view of the proximal portion of an illustrative catheter system in its first configuration;

[0029] Figure 3 It is in the second form Figure 1 A schematic partial cross-sectional view of the proximal end of the illustrative catheter system shown.

[0030] Figure 4 This is a schematic cross-sectional view illustrating the repositioning of the sheath;

[0031] Figure 5 It is a schematic cross-sectional view illustrating the repositioning of the sheath with a hub and positioned on a slender shaft;

[0032] Figures 6A to 6F A schematic flow diagram illustrating the techniques for adjusting tubing assemblies in a conduit system is depicted; and

[0033] Figures 7A to 7B An illustrative process for adjusting the tubing components of a conduit system is described.

[0034] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that the invention is not intended to limit its aspects to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0035] For the purposes of the following definitions, unless otherwise specified in the claims or elsewhere in this specification, these definitions shall apply.

[0036] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated otherwise. The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the cited figures (i.e., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0037] A description of a range of numbers represented by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise expressly indicated. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless otherwise expressly indicated.

[0039] It should be noted that references to "one configuration," "some configurations," "other configurations," etc., in this specification indicate that the configuration may include one or more specific features, structures, and / or characteristics. However, these descriptions do not necessarily mean that all configurations include that specific feature, structure, and / or characteristic. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with a configuration, it should be understood that, whether explicitly described or not, such feature, structure, and / or characteristic may also be used in conjunction with other configurations, unless explicitly stated otherwise.

[0040] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings have the same numbering. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0041] Figure 1 A perspective view of catheter 10 (e.g., a mechanical circulatory support system and / or other suitable catheter system) is shown, which includes a percutaneous blood pump 50 located in its distal region. The blood pump 50 is configured to pump blood from the ventricles of a subject's (e.g., a patient's) heart to the subject's vascular system and / or other parts of the circulatory system.

[0042] The catheter 10 may be coupled to or may include the blood pump 50, wherein an elongated shaft 12 of the catheter 10 (e.g., an elongated tube having one or more elongated members extending therein) extends proximally from the percutaneous blood pump 50, and a distal tip 40 extends distally from the blood pump 50. For example, the proximal end 16 of the elongated shaft 12 may be coupled to a housing 14 (e.g., a housing of a handle, control module, etc.), and the distal end 18 of the elongated shaft 12 may be coupled to the percutaneous blood pump 50. A cable 22 may extend from the housing 14 to a connector 24 located proximally thereto. The connector 24 may be configured to connect to a controller (not shown) for controlling the blood pump 50, such as providing power to the blood pump 50, control signals, etc. The catheter 10 may also include an extension 26, which may be coupled to a controller for sending and / or receiving signals, such as signals from one or more sensors, during operation of the blood pump 50.

[0043] When the blood pump 50 is inserted into a subject (e.g., a patient), the blood pump 50 can be inserted through an infeeder sheath that is inserted into the subject's vascular access site. In some cases, the infeeder sheath may be a large-bore sheath configured to receive the blood pump 50 and the elongated shaft 12 and to facilitate the passage of the blood pump 50 and the elongated shaft 12. In some cases, the outer diameter of the infeeder sheath may tend to impede the free flow of blood through the femoral artery to the subject's leg.

[0044] To facilitate blood perfusion to the subject's leg, the infeeder sheath can be replaced with a smaller outer diameter sheath, such as a repositioning sheath. To facilitate removal of the infeeder sheath from the vascular access site, the infeeder sheath can be a tear-away sheath, wherein the infeeder sheath can be configured to split along a perforation line that extends along all or at least part of the length of the infeeder sheath; and / or can be removed from the catheter 10 in one or more other suitable manners.

[0045] For various reasons, tearable inserter sheaths can be undesirable. In some cases, tearable inserter sheaths may tear unintentionally or uncontrollably, potentially leading to vascular injury. In some cases, tearable inserter sheaths may be formed from polymers, which may require thicker walls than other materials used to form inserter sheaths (e.g., metals) to create walls with similar strength to sheaths made from other materials. Therefore, when using polymer tearable inserter sheaths, it may be necessary to create larger openings or access sites in the subject to receive the inserter sheath compared to using non-tearable inserter sheaths.

[0046] The concepts discussed herein include the use of an introducing sheath and a repositioning sheath, both configured to receive and advance along an elongated shaft 12. In some configurations, the repositioning sheath may be longer than the introducing sheath, such that before, during, or after complete withdrawal of the introducing sheath from the passage, the distal end of the repositioning sheath can be inserted into the passage to a position distal to the distal end of the introducing sheath, while the proximal hub of the repositioning sheath is proximal to the proximal hub of the introducing sheath.

[0047] Figure 2 A schematic partial cross-sectional view depicting an illustrative configuration of the proximal end of catheter 10 is shown. The proximal end of catheter 10 may include an elongated axis 12 extending distally from housing 14 through sterile cannula 28, introducer sheath 30 (e.g., a first sheath), and repositioning sheath 32 (e.g., a second sheath), wherein sterile cannula 28, introducer sheath 30, and repositioning sheath 32 are depicted in cross-section.

[0048] In some cases, the delivery device sheath 30 can be used to facilitate the entry of various medical devices, such as the elongated shaft 12, blood pump 50, etc., through the subject's access site into the subject's blood vessels. The delivery device sheath 30 may include a proximal region 30a immediately adjacent to the proximal end of the delivery device sheath 30 and a distal region 30b immediately adjacent to the distal end of the delivery device sheath 30. A body region 30c of the delivery device sheath 30 may extend between the proximal region 30a and the distal region 30b, wherein one or more of the proximal region 30a, the distal region 30b, and the body region 30c may define a lumen 34 of the delivery device sheath 30. Furthermore, the delivery device sheath 30 may include a proximal opening 36 located or immediately adjacent to the proximal region 30a and a distal opening 38 located or immediately adjacent to the distal region 30b, wherein the lumen 34 extends between the proximal opening 36 and the distal opening 38. The lumen 34 may define the inner diameter of the delivery device sheath 30.

[0049] The injector sheath 30 may be formed of one or more suitable materials. Examples of suitable materials include, but are not limited to, polymeric and / or metallic materials. In some cases, the injector sheath 30 may include one or more additional surface coatings on the inner and / or outer surfaces defining the cavity 34, which may include, but are not limited to, silicone, polyethylene terephthalate (PET), and / or other suitable coating materials.

[0050] The delivery device sheath 30 (e.g., at its proximal region) may include a hub 42 (e.g., a proximal hub, such as a hemostatic valve hub and / or other suitable hub) that provides access to the lumen 34. The hub 42 may be configured to achieve hemostasis, for example, by preventing or reducing blood leakage from the delivery device sheath 30 during use. For example, a medical device, such as an elongated shaft 12 and / or a blood pump 50, may be inserted through the hub 42 and the lumen 34 of the delivery device sheath 30 into a subject's blood vessel, and the hub 42 may maintain hemostasis between the medical device, the delivery device sheath 30, and the external environment.

[0051] After positioning the medical device at the target site within the subject's body, it may be necessary to stabilize the axial and radial position of the medical device to ensure that the medical device (and any devices attached to it) remain in proper position during use. Repositioning of the medical device by a medical professional may also be required after insertion. Therefore, the hub 42 may include a tightening port 44 provided or attachable thereto, which provides fixation of the medical device (e.g., the elongated shaft 12) relative to the hub 42. Furthermore, for attaching the inserter sheath 30 relative to the subject's access site, the hub 42 may include or be attachable to one or more suture pads 43 (e.g., as shown in the image). Figure 2 Two suture pads 43 extending from hub 42 are shown. Suture pads 43 may be sutured and / or otherwise attached to the skin surface of the subject.

[0052] The stitching pad 43 may be separable from other parts of the hub 42. In some examples, the stitching pad 43 may include or be coupled to a stitching pad ring 45, which is releasably coupled to the hub 42 (e.g., as shown in the image). Figure 3 (as shown) and configured to advance along the inlet sheath 30 and engage with the repositioning sheath 32 when disconnected from the hub 42.

[0053] The seam insert 45 can be engaged with the hub 42 in any suitable manner. Examples of suitable engagement mechanisms include, but are not limited to, Luer connections, clips, snap-fit ​​connections, friction-fit connections, rotary tightening mechanisms, threads, and / or other suitable types of engagement mechanisms. In some examples, the seam insert 45 may be configured to engage with the hub 42 using a friction-fit connection, but this is not required. The engagement mechanism may be integral with and / or separate from the seam insert 45.

[0054] The suture ring 45 can be engaged with the repositioning sheath 32 in any suitable manner. Examples of suitable engagement mechanisms include, but are not limited to, Luer connections, clips, snap-fit ​​connections, friction-fit connections, rotary tightening mechanisms, threads, and / or other suitable types of engagement mechanisms. In some examples, the suture ring 45 may be configured to engage with the repositioning sheath 32 using a clip connection, but this is not required. The engagement mechanism may be integral with and / or separate from the suture ring 45.

[0055] The tightening port 44 of the hub 42 can be any suitable type of tightening port. For example, the tightening port 44 can engage the elongated shaft 12 in response to rotation of a rotary actuator of the tightening port 44, adjusting the clamp of the tightening port 44, and / or the tightening port 44 can engage the elongated shaft 12 according to one or more additional or alternative coupling techniques discussed herein or elsewhere. Furthermore, in some cases, the tightening port 44 and / or other suitable portions of the hub 42 can be configured to receive and engage with the hub 60 (e.g., a proximal hub) of the repositioning sheath 32 and / or other portions of the repositioning sheath 32.

[0056] The injector sheath 30 may have any suitable length L1. In some examples, the length L1 of the injector sheath 30 may extend from the proximal end of the injector sheath 30 located at or immediately adjacent to the lateral opening 36 to the distal end of the injector sheath 30 located at or immediately adjacent to the distal opening 38. Example suitable lengths of the injector sheath 30 include, but are not limited to, lengths ranging from about 13 cm to about 33 cm.

[0057] The repositioning sheath 32 can be configured to replace the inserter sheath 30 at the access site and can be configured to be advanced along the elongated axis 12 and through the inserter sheath 30 to reach the subject's access site. For example, once the blood pump 50 has been positioned within the subject's blood vessel and / or at the target site within the subject's body, the repositioning sheath 32 (e.g., the distal end of the repositioning sheath 32) can be advanced through the inserter sheath 30 toward the access site to a position distal to the distal end of the inserter sheath 30 and positioned across the access site within the subject's blood vessel. The repositioning sheath 32 can be inserted into the access site and the subject's blood vessel before, during, and / or after the inserter sheath 30 has been removed from the access site.

[0058] When positioned within a blood vessel in the subject, the repositioning sheath 32 facilitates the repositioning of the blood pump 50 at or near the target site within the subject's body by advancing the slender shaft 12 extending through the repositioning sheath 32 into the access site and blood vessel. Because the outer diameter of the repositioning sheath 32 is smaller than that of the delivery sheath 30, the repositioning sheath 32 facilitates increased blood perfusion through the blood vessel compared to the blood perfusion that occurs when the delivery sheath 30 is located within the blood vessel. Furthermore, the stiffness or rigidity of the repositioning sheath 32 may be less than that of the delivery sheath 30, which reduces trauma to the subject at the access site and minimizes the impact of movement of the catheter 10 proximal to the access site on the position of the blood pump 50 at the target site.

[0059] The repositioning sheath 32 may include a proximal region 32a immediately adjacent to the proximal end of the repositioning sheath 32 and a distal region 32b immediately adjacent to the distal end of the repositioning sheath 32. A body region 32c of the repositioning sheath 32 may extend between the proximal region 32a and the distal region 32b, wherein one or more of the proximal region 32a, the distal region 32b, and the body region 32c may define a lumen 54 of the repositioning sheath 32. Furthermore, the repositioning sheath 32 may include a proximal opening 56 located or immediately adjacent to the proximal region 32a and a distal opening 58 located or immediately adjacent to the distal region 32b, wherein the lumen 54 extends between the proximal opening 56 and the distal opening 58.

[0060] The repositioning sheath 32 may have any suitable configuration between the proximal region 32a and the distal region 32b. In some examples, the outer diameter of the repositioning sheath 32 may vary along its length. In one example, the outer diameter of the distal region 32b of the repositioning sheath 32 may be smaller than that of the proximal region 32a and / or the main region 32c, wherein the outer diameter of the repositioning sheath 32 may taper distally between or at the main region 32c and the distal region 32b. The tapering or reduced outer diameter at the distal region 32b may facilitate reduced leg ischemia due to the relatively small outer diameter portion of the repositioning sheath 32 located in the subject's blood vessels, and / or may facilitate reinsertion of the repositioning sheath 32 through the access site into the subject's body.

[0061] The repositioned sheath 32 can have any suitable number of lumens. Although Figure 2 Only a single lumen 54 of the repositioned sheath 32 is depicted, but the repositioned sheath 32 may also have a single lumen, two lumens, three lumens and / or other suitable number of lumens as needed.

[0062] The repositioning sheath 32 can have any suitable length L R In some examples, the length L of the sheath 32 is repositioned. R The repositioning sheath 32 can extend from its proximal end, located at or immediately adjacent to the lateral opening 56, to its distal end, located at or immediately adjacent to the distal opening 58. Example suitable lengths of the repositioning sheath 32 include, but are not limited to, lengths ranging from approximately 13 cm to approximately 40 cm. The length L of the repositioning sheath 32... R It can be configured to be longer than the length L1 of the delivery sheath 30, such that the distal end of the repositioning sheath 32 is configured to be advanced through the access site into the blood vessel, while allowing the delivery sheath 30 to be advanced proximally from the access site on the repositioning sheath 32 (e.g., withdrawn), such that the hub 60 of the repositioning sheath 32 can be connected to or positioned near the hub 42 of the delivery sheath 30.

[0063] The repositioning sheath 32 can be formed in any suitable manner. In some examples, the repositioning sheath 32 can be formed using one or more extrusion processes and / or other suitable manufacturing processes. When the repositioning sheath 32 forms more than one cavity, different cavities can be formed by combining multiple tubes within an outer tube, but this is not necessary, and other configurations for forming multiple cavities are conceivable. In one example, when the repositioning sheath 32 includes two cavities, the first cavity can be formed by a first tube, the second cavity can be formed by a second tube, and a third tube can surround the first and second tubes to form the outer surface and / or outer diameter of the repositioning sheath 32. When using multiple tubes, the tubes of the repositioning sheath 32 can be joined using any suitable joining technology, including but not limited to adhesives, reflow processes, and / or other suitable joining technologies.

[0064] The repositioning sheath 32 may be formed of one or more suitable materials. Examples of suitable materials include, but are not limited to, polymeric and / or metallic materials. In some cases, the repositioning sheath 32 may include one or more additional surface coatings on the inner and / or outer surfaces of the defining cavity 54, which may include, but are not limited to, silicone, polyethylene terephthalate (PET), and / or other suitable coating materials.

[0065] The repositioning sheath 32 may have any suitable outer diameter, smaller than that of the inserter sheath 30, to better facilitate blood perfusion through the blood vessel inserted by the subject with the elongated shaft 12, and to reduce the opening diameter maintained at the subject access site when the blood pump 50 is positioned at the target site (e.g., during indwelling). In some examples, the outer diameter of the repositioning sheath 32 may be smaller than the inner diameter of the inserter sheath 30 to allow the repositioning sheath 32 to pass through the inserter sheath 30, but this is not necessary, and the inserter sheath 30 may be configured to stretch radially outward or bend to allow the repositioning sheath 32 to pass through the inserter sheath 30.

[0066] The hub 60 may be located at and / or connected to the repositioning sheath 32 and may be considered part of the repositioning sheath 32, but this is not necessary. The hub 60 may facilitate the formation of the proximal opening 56 of the repositioning sheath 32 and may facilitate the reception of one or more components of the catheter 10 and / or connection thereto.

[0067] In some cases, hub 60 may include one or more coupling mechanisms configured to engage with elongated shaft 12 (e.g., elongated shaft lock) to releasably secure elongated shaft 12 relative to repositioning sheath 32. Suitable coupling mechanisms include, but are not limited to, clips, snap-fit ​​connections, friction-fit connections, rotary tightening mechanisms, threads, and / or other suitable types of coupling mechanisms. In some examples, hub 60 may include a rotary tightening coupling mechanism configured to engage with elongated shaft 12 at a desired location along elongated shaft 12.

[0068] The hub 60 of the repositioning sheath 32 may include a head 46 for receiving and / or engaging with a sterile cannula 28. In some examples, the port 64 may be configured to receive the head 46 of the sterile cannula 28 within the lumen 54 to engage the sterile cannula 28 with the repositioning sheath 32 (e.g., via a friction-fit connection, Luer connection, clip or snap connection, thread and / or other suitable type of connection) and create a sterile field between the proximal end of the repositioning sheath 32 and the distal end of the housing 14 along the elongated axis 12 during medical procedures.

[0069] The sterile cannula 28 may extend distally from the housing 14 along an elongated shaft 12. In some configurations of the sterile cannula 28, the sterile cannula 28 may include a distal head 46 and a tubular member 48 extending proximally from the head 46 to the housing 14. The tubular member 48 of the sterile cannula 28 may be flexible and configured to have a pleated position 52 when there is a slack between the head 46 of the sterile cannula 28 and the housing 14, for example, as shown in the image. Figure 2 As depicted in the text.

[0070] The tubular component 48 of the sterile sheath 28 can be formed from any suitable material. Examples of suitable materials for forming the tubular component 48 include, but are not limited to, polyurethane, thermoplastic polyurethane (TPU), polyethylene, ethylene vinyl acetate (EVA), and / or other suitable materials.

[0071] Figure 3 The catheter 10 is depicted, wherein a repositioning sheath 32 is advanced distally through an inserter sheath 30 and / or proximally through the inserter sheath 30, such that a portion (e.g., at least distal) of the repositioning sheath 32 located distal to the inserter sheath 30 has sufficient length to pass through the subject's access site into the subject's blood vessel. In some examples and as... Figure 3 As depicted, when the repositioning sheath 32 is advanced distally relative to the infeeder sheath 30, the hub 60 of the repositioning sheath 32 may abut against the hub 42 of the infeeder sheath 30. Although not essential, the hub 60 of the repositioning sheath 32 may be configured to be fixed to the hub 42 of the infeeder sheath 30.

[0072] like Figure 3As depicted, the suture ring 45 can be detached from a portion of the hub 42 and the infeeder sheath 30 and advanced distally over both the infeeder sheath 30 and the repositioning sheath 32. Subsequently, the suture ring 45 can be engaged with the repositioning sheath 32 at a position distal to the distal end of the infeeder sheath 30. The suture ring 45 can be engaged with the hub 42 and the repositioning sheath 32 using the same or different engagement techniques or mechanisms as needed. In one example, the suture ring 45 can be engaged with at least the repositioning sheath 32 using a clip connection.

[0073] Figure 4 A schematic cross-sectional view depicting an illustrative configuration of the repositioning sheath 32, independent of other components of the catheter 10. Although not essential, the repositioning sheath 32 may be a double-lumen sheath having a first tube 66 defining a first lumen 68 (e.g., the first lumen 68 may be the lumen 54 discussed above, configured to receive the elongated shaft 12 of the catheter 10); a second tube 70 extending along the first tube 66 and defining a second lumen 72 configured to receive one or more wires; and a third tube 74 extending over the first tube 66 and the second tube 70. Other suitable configurations of the repositioning sheath 32 are contemplated. In some cases, the third tube 74 may define a third lumen 76, but this is not essential, and the third tube 74 may be configured to fit over the first tube 66 and the second tube 70 and fill the gaps around the first tube 66 and the second tube 70 (e.g., via heat shrinking, etc.).

[0074] The first tube 66, the second tube 70, and / or the third tube 74 may be formed of one or more suitable materials. Examples of suitable materials include, but are not limited to, polymers and / or metallic materials. In some cases, the first tube 66, the second tube 70, and / or the third tube 74 may include one or more additional surface coatings on the inner and / or outer surfaces defining the cavities 68, 72, 76, which may include, but are not limited to, silicone, polyethylene terephthalate (PET), and / or other suitable coating materials.

[0075] The first chamber 68 may include a hemostatic valve 78 (e.g., an internal hemostatic valve) extending across the first chamber 68 (e.g., chamber 54 configured to receive the elongated shaft 12) to prevent blood from flowing through the first chamber 68 and out of the repositioned sheath 32. Alternatively or additionally, the second chamber 72 may include a hemostatic valve (not shown).

[0076] The hemostatic valve 78 can be any suitable type of valve configured to block blood flow through, for example, the first chamber 68. In some examples, the hemostatic valve 78 can be a silicone disc with and / or formed therefrom having a cross-cut 81 configured to receive the elongated shaft 12 and allow the repositioned sheath 32 to pass over and seal around the elongated shaft 12. However, it is conceivable that the hemostatic valve 78 can be formed of one or more additional or alternative materials and / or include one or more other suitable cuts or openings configured to receive the elongated shaft 12 and seal around it.

[0077] Figure 5 A depiction of a component with conduit 10 Figure 4 The illustration shows a schematic cross-sectional view of the repositioning sheath 32. For example, the repositioning sheath 32 may include a hub 60, and an elongated shaft 12 may extend through a first lumen 68 and a hemostatic valve 78.

[0078] The sterile cannula 28 may extend along the elongated shaft 12 to create a sterile boundary along the elongated shaft 12 from the hub 60 to the housing 14. Figure 5 (Not shown in the image). In some examples, the head 46 of the sterile cannula 28 may be coupled to the hub 60, as discussed above.

[0079] Hub 60 may be configured to receive probe 80 having wire 82 and cap 84 located at a port, such as side port 71 and / or at one or more other suitable ports. Probe 80 may be inserted into hub 60 and repositioned sheath 32 such that wire 82 may extend through second cavity 72 (e.g., where side port 71 may communicate with second cavity 72), but this is not required, and wire 82 may extend through one or more other suitable cavities. When wire 82 of probe 80 extends through second cavity 72, wire 82 may be configured to prevent second cavity 72 from being blocked by clotted blood, but this is not required.

[0080] The cap 84 of probe 80 can be configured to engage with hub 60 (e.g., with the proximal end of side port 71) using any suitable adjustable or detachable coupling technology and / or mechanism. Examples of suitable coupling technologies and / or mechanisms include, but are not limited to, Luer connections, clips, snap-fit ​​connections, friction-fit connections, rotary tightening mechanisms, threads, and / or other suitable types of coupling mechanisms.

[0081] Figures 6A to 6F An illustrative technique for replacing the infeeder sheath 30 with a repositioning sheath 32 at the access site 86 in the body of the subject 88 is schematically depicted. Although the illustrative technique for replacing the infeeder sheath 30 with a repositioning sheath 32 is discussed in relation to the components of the catheter 10, other suitable components may also be used as needed.

[0082] Figure 6A The catheter 10 is schematically depicted in the access site 86 of the subject 88, wherein the elongated shaft 12 extends proximally from the proximal hub 42 of the introducer sheath 30 through the repositioning sheath 32 and the sterile cannula 28. During the advancement (e.g., insertion) of the blood pump 50 and the elongated shaft 12 through the introducer sheath 30 and into the subject 88, the repositioning sheath 32 and the sterile cannula 28 may be held proximal to the introducer sheath 30. In some cases, the sterile cannula 28 may be coupled to the hub 60, and the hub 60 may be coupled or secured to the elongated shaft 12 via an elongated shaft lock 85 in a locked position or configuration, but this is not necessary.

[0083] Figure 6B An infeeder sheath 30 positioned in access portion 86 is schematically depicted, wherein a repositioning sheath 32 is advanced distally along an elongated axis 12 into the infeeder sheath 30. Prior to advancing the repositioning sheath 32 along the elongated axis 12, an elongated shaft lock 85 of the hub 60 or an adjacent elongated shaft lock 85 can be adjusted from a locked position or configuration to an unlocked position or configuration to disengage the elongated shaft lock 85 from the elongated axis 12. Once the elongated shaft lock 85 is in the unlocked position or configuration, the user can advance the distal end of the repositioning sheath 32 into the infeeder sheath 30 to a position beyond access portion 86 and distal to the distal end of the infeeder sheath 30, and into a blood vessel, but the repositioning sheath 32 can also be advanced distally in one or more other ways. Furthermore, a sterile sleeve 28 can be advanced distally together with the repositioning sheath 32, such as... Figure 6B As shown, but this is not necessary, and the repositioning sheath 32 can be advanced distally into the introducer sheath 30 and the subject 88 independently of the sterile cannula 28. Advancing the repositioning sheath 32 into the introducer sheath 30 and / or the subject 88 can occur when the introducer sheath 30 is within the access site 86, but this is not necessary, and the introducer sheath 30 can be removed from the access site 86 before, during, or after removal from the access site 86.

[0084] Figure 6C The diagram schematically depicts an introducing sheath 30 advancing proximally from the access portion 86 (e.g., fully withdrawn from the access portion 86, with the distal end of the introducing sheath 30 located proximally to the access portion 86), and a repositioning sheath 32 extending into the access portion 86 (e.g., the distal end of the repositioning sheath 32 located distal to the distal end of the introducing sheath 30). When the introducing sheath 30 is advanced proximally, a hub 42 can be advanced on the repositioning sheath 32 to a position located at or adjacent to a hub 60 for engagement with it.

[0085] If the suture pad 43 of hub 42 is sutured to subject 88, the suture can be removed from the suture pad 43 and / or subject 88 before the infeeder sheath 30 is withdrawn from the access site 86. Alternatively, the suture pad 43 can be detached from hub 42 and the suture can remain in place while the infeeder sheath 30 is withdrawn from the access site 86.

[0086] When the injector sheath 30 is fully withdrawn from the access portion 86, the hub 42 of the injector sheath 30 may engage or engage with the hub 60 of the repositioning sheath 32. In some examples, the hub 42 may be releasably engaged with the hub 60 in any suitable manner discussed herein or elsewhere to secure the injector sheath 30 relative to the repositioning sheath 32.

[0087] Figure 6D A suture pad ring 45 and a suture pad 43 are schematically depicted detached from or separated from the hub 42 of the infeeder sheath 30 and advanced distally toward the access portion 86 (e.g., when the suture pad 43 is advanced proximally together with the infeeder sheath 30). The suture pad 43 may be detached from the hub 42 and / or other portions of the infeeder sheath 30 and advanced toward the access portion 86 on the infeeder sheath 30 to facilitate suturing the suture pad 43 to the subject 88 at a location on and / or immediately adjacent to the access portion 86 of the repositioned sheath 32. The suture pad ring 45 may be detached from the infeeder sheath 30 and / or hub 42 by any suitable means discussed herein or elsewhere. However, when the suture pad 43 is not detached from other parts of the hub 42, the suture pad 43 may be sutured to the subject at or immediately adjacent to the hub 42.

[0088] Figure 6E The suture pad 43 and suture pad ring 45 are schematically depicted adjacent to the access portion and positioned distal to the distal end of the introducer sheath 30 and along the repositioning sheath 32. When positioned on the repositioning sheath 32 located distal to the introducer sheath 30, the suture pad ring 45 can be adjusted to engage with the repositioning sheath 32 located proximal to and adjacent to the access portion 86.

[0089] The suture ring 45 may be coupled to the repositioning sheath 32 in any suitable manner discussed herein or elsewhere. In some examples, the suture ring 45 may be coupled to the repositioning sheath 32 in a manner similar to how the suture ring 45 may be coupled to the infeeder sheath 30 and / or hub 42. In one example, the suture ring 45 may be coupled to the repositioning sheath 32 using a clip or snap on or separate from the suture ring 45, but other configurations are also contemplated.

[0090] Once adjacent to the access site 86, the suture pad 43 can be sutured to the subject 88. Suturing the suture pad 43 to the subject can occur before, during, or after connecting the suture pad ring 45 to the repositioning sheath 32, as needed.

[0091] Figure 6F A clip 90 (e.g., a suture pad clip or other suitable clip) is schematically depicted engaging the suture pad ring 45 and the repositioning sheath 32. In some cases, when the suture pad ring 45 does not include a engagement mechanism, and / or in other cases, the clip 90 may be used to engage the repositioning sheath 32 with or relative to the suture pad ring 45 when the suture pad ring 45 is located at or around the repositioning sheath 32.

[0092] In some examples, the clip 90 may include wings 91 (e.g., two wings and / or other suitable number of wings). In operation, when the clip 90 is loaded onto the repositioning sheath 32 and the suture pad ring 45, the wings 91 may be compressed toward each other. Subsequently, the wings 91 may be released to allow the clip 90 to engage the repositioning sheath 32 and the suture pad ring 45, and to secure the repositioning sheath 32 and the suture pad ring 45 relative to each other. Other suitable clips 90 are contemplated.

[0093] Furthermore, the elongated shaft lock 85 of the hub 60 of the repositioning sheath 32 can be adjusted from an unlocked position or configuration to a locked position or configuration to secure the hub 60 together with one or more of the sterile cannula 28, the introducer sheath 30, and the repositioning sheath 32 to or relative to the elongated shaft 12. Securement of the hub 60 relative to the elongated shaft 12 can occur at any appropriate time after the repositioning sheath 32 has been positioned through the access site 86 into the blood vessel of the subject 88.

[0094] Figure 7A and Figure 7B An illustrative technique for repositioning the blood pump 50 (not shown) by advancing an elongated shaft 12 located proximal to the repositioning sheath 32 is schematically depicted. Although the illustrative technique for repositioning the blood pump 50 is discussed in relation to the components of the catheter 10, other suitable components may be used as needed.

[0095] Figure 7A A sterile cannula 28 is schematically depicted connected to a hub 60 proximal to the repositioning sheath 32. In preparation for adjusting the position of the blood pump 50, the elongated shaft lock 85 of the hub 60, or at the hub 60, can be opened or adjusted to an unlocked position or configuration, allowing the elongated shaft 12 to be repositioned relative to the sterile cannula 28, the introducing sheath 30, and / or the repositioning sheath 32. Furthermore, Figure 7AThe image depicts a gripping position 92 along the sterile cannula 28 and the slender shaft 12, where the slender shaft 12 can be gripped via the sterile cannula 28 to adjust the blood pump 50.

[0096] Figure 7B The diagram schematically depicts an elongated shaft 12 and a sterile cannula 28 that are advanced (e.g., adjusted) in the direction of arrow A. Figure 7B In the example depicted where adjusting the elongated shaft 12 to adjust the position of the blood pump 50 involves the user grasping the elongated shaft 12 at a gripping position 92 via a tubular member 48 (e.g., a flexible tubular member) of the sterile cannula 28 and advancing both the elongated shaft 12 and the tubular member 48 distally, this results in the advancement of the blood pump 50 within the subject 88 and the creation of a folded position 52 in the tubular member 48 distal to the gripping position 92. The blood pump 50 can be adjusted proximally by advancing the elongated shaft 12 and the tubular member 48. Once the blood pump 50 and / or the elongated shaft 12 have been adjusted to the desired position, the elongated shaft lock 85 at the hub 60 or the hub 60 can be adjusted to a locked position or configuration to secure the elongated shaft 12 relative to the sterile cannula 28, the injector sheath 30, and / or the repositioning sheath 32.

[0097] Although not shown, catheter 10 may be used in one or more other techniques and / or methods, including, but not limited to, techniques for removing blood pump 50 from subject 88 and / or techniques for reinserting inserter sheath 30 after removal from access site 86. Although illustrative techniques for removing blood pump 50 and / or for reinserting inserter sheath 30 into access site are described below with respect to components of catheter 10, other suitable components and / or other suitable blood pump techniques may be used as needed.

[0098] In the illustrative removal technique, the user can pull the probe 80 out of the hub 60 of the repositioning sheath 32. In some examples, the cap 84 can be disconnected from the hub 60 (e.g., unscrewed, etc.) and advanced (e.g., pulled out) in a direction away from the hub 60 to remove the wire 82 of the probe 80 from the repositioning sheath 32 (e.g., from the second cavity 72 of the repositioning sheath 32).

[0099] The syringe can be positioned at the cavity (e.g., second cavity 72) of the repositioning sheath 32 where the wire 82 was previously positioned, to provide fluid communication with the cavity. In some cases, the syringe can be coupled to the hub 60 in the same or similar manner as the probe 80. When using the syringe, the user can flush (e.g., by aspiration) the cavity to remove any debris therein. Although the syringe is described as being for flushing the cavity, other suitable components may also be used for flushing the cavity, including but not limited to electromechanical aspiration devices and / or other suitable devices.

[0100] The filament can be inserted into the hub 60 of the repositioning sheath 32. In some examples, the filament can be inserted into the hub 60, into the lumen (e.g., second lumen 72) of the repositioning sheath 32 where the filament 82 of the probe 80 is located, and into the body of the subject 88 (e.g., in the blood vessel where the elongated shaft 12 is located) via the repositioning sheath 32 and access site 86. In some cases, after the blood pump 50 is removed from the subject 88, the filament can be retained at the access site 86 within the subject 88 to facilitate one or more additional treatments or procedures (if needed) after the removal of the blood pump 50 from the subject 88. The filament can be used for other suitable purposes as needed.

[0101] The wire can have any suitable diameter. In some examples, the wire may have a diameter of 0.035 inches (or 0.889 millimeters), but other suitable diameters are also conceivable. The wire may be a guide wire, but other suitable wires are also conceivable.

[0102] Once the filament has been placed inside the subject, the elongated shaft lock 85 of hub 60 or at hub 60 can be adjusted to the unlocked position or configuration, and the elongated shaft 12 can be advanced proximally relative to the repositioning sheath 32 to move the blood pump 50 into the descending aorta of the subject 88 while maintaining the position of the filament within the subject 88. Moving the blood pump 50 into the descending aorta of the subject 88 can occur before, during, or after the removal of the repositioning sheath 32 from the access site 86. In some examples, the elongated shaft lock 85 can remain in the locked configuration, and the repositioning sheath 32 can be withdrawn from the access site 86 as the elongated shaft 12 is advanced proximally to move the blood pump 50 into the descending aorta while maintaining the position of the filament 96 within the subject 88; however, this is not necessary.

[0103] Once the repositioning sheath 32 has been completely removed from the access site 86, the suture can remain in place within the access site 86 (e.g., via tape, user, etc.), and the user can completely withdraw the elongated shaft 12 and the blood pump 50 from the subject 88. After the blood pump 50 is removed from the user, the access site 86 can be closed around the suture to prevent leakage of bodily fluids (e.g., blood). Closing the access site 86 may include suturing the access site closed around the suture and / or one or more other suitable closure techniques.

[0104] In some examples, after removing the infeeder sheath 30 from the access site 86, it may be necessary to reinsert the infeeder sheath 30 into the access site 86. Reinserting the infeeder sheath 30 into the access site 86 facilitates the replacement of the blood pump used to treat the subject 88 and / or the performance of other interventional procedures.

[0105] In one example of reinserting the introducer sheath 30 after removal from access site 86, the introducer sheath 30 may be reinserted into access site 86 while the repositioning sheath 32 extends within access site 86. As the repositioning sheath 32 extends through access site 86 and into the subject 88, the introducer sheath 30 may be advanced distally over the repositioning sheath 32 and into access site 86 to reach a position within the blood vessel of the subject 88. Although not essential, the introducer sheath 30 may be advanced through suture pad 43 as it is advanced over the repositioning sheath 30. The clip 90 may be removed before reinserting the introducer sheath 30 into the subject 88 when the clip 90 is attached to the repositioning sheath 32 and suture pad 43. After reinsertion of the introducer sheath 30, the repositioning sheath 32 and blood pump 50 may be removed from the subject 88 through the lumen 34 of the introducer sheath 30. Subsequently, a new blood pump 50 and / or other suitable device may be inserted through the lumen 34 of the infeeder sheath 30, across the access site 86, into the blood vessel of the subject 88 for use in one or more interventional procedures and / or surgeries.

[0106] In additional or alternative examples of reinserting the introducer sheath 30 into the access site 86 after removal from the access site 86 (e.g., and into a blood vessel of the subject 88), the introducer sheath 30 may be reinserted into the access site 86 together with the repositioning sheath 32. In some examples, as discussed above and / or elsewhere, the repositioning sheath 32 may be removed from the subject's body on the filament through which it is inserted, and the filament may remain within the access site 86 of the subject 88. When the filament extends from the subject 88 via the access site 86 and / or in other cases, the repositioning sheath 32 and the introducer sheath 30 may be reinserted into the access site 86 by distal advancement into the access site 86, wherein the repositioning sheath 32 may be traced on the filament. The repositioning sheath 32 may be proximally pushed out of the access site 86 before, during, or after positioning the introducer sheath 30 in a blood vessel of the subject 88. In some examples, the suture extending through the access site 86 may be advanced proximally before, during, or after insertion of the introducer sheath 30 into the blood vessel of the subject 88 to withdraw the suture from the subject 88. After reinsertion of the introducer sheath 30, the blood pump 50 may be removed from the subject 88 through the lumen 34 of the introducer sheath 30. Subsequently, a new blood pump 50 and / or other suitable device may be inserted through the lumen 34 of the introducer sheath 30, across the access site 86, into the blood vessel of the subject 88 for use in one or more interventional procedures and / or surgeries.

[0107] Unless otherwise expressly stated, the illustrative methods and techniques discussed herein may be used together. Furthermore, unless otherwise expressly stated, the order of execution of the steps discussed herein may include one or more intermediate steps discussed herein or elsewhere.

[0108] It should be understood that the present invention is illustrative in many respects only. Changes may be made in details, particularly in the arrangement of shapes, sizes, and steps, without departing from the scope of the invention. To the appropriate extent, this may include using any feature used in one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A mechanical circulation support system, the system comprising: A blood pump configured to pump blood from the ventricles of a patient's heart to the patient's vascular system; case; An elongated shaft, which is connected to the blood pump and extends proximally from the blood pump to the housing; A first sheath having a first hub, the first sheath having a cavity with an inner diameter; as well as A second sheath having a second hub, the outer diameter of the second sheath being smaller than the inner diameter of the cavity, and The first sheath and the second sheath are configured to advance longitudinally along the elongated axis, and the distal end of the second sheath is configured to advance through the cavity of the first sheath and extend distally beyond the distal end of the first sheath.

2. The system of claim 1, wherein the first sheath is an introductory sheath configured to allow the blood pump to pass through the cavity.

3. The system according to claim 1 or claim 2, wherein the second sheath is a double-lumen sheath.

4. The system of claim 3, wherein the dual-lumen sheath comprises a first tube defining a first lumen, a second tube extending along the first tube and defining a second lumen, and a third tube extending over the first tube and the second tube.

5. The system according to claim 3 or claim 4, further comprising: Wire, and The dual-lumen sheath defines a first cavity configured to receive the elongated shaft and a second cavity configured to receive the wire.

6. The system according to any one of claims 1 to 5, wherein the second sheath includes an internal hemostatic valve.

7. The system according to any one of claims 1 to 6, wherein the first hub is configured to engage with the second hub when the distal end of the second sheath is located distal to the distal end of the first sheath.

8. The system according to any one of claims 1 to 7, wherein the first hub includes a stitching pad configured to be disassembled from the first hub and slid on the first sheath to a position around the second sheath when the distal end of the second sheath is located distal to the distal end of the first sheath.

9. The system according to claim 8, further comprising: A clip configured to engage the suture pad with the second sheath when the suture pad is located in the position surrounding the second sheath.

10. The system according to any one of claims 1 to 9, wherein the second hub includes an adjustable shaft lock configured to releasably secure the second hub relative to the elongated shaft.

11. A method for adjusting a pipe assembly for a mechanical circulation support system, the method comprising: The blood pump and the slender shaft extending proximally from the blood pump pass through the first sheath; The distal end of the second sheath is advanced along the elongated shaft and passed through the distal end of the first sheath to a position located distal to the distal end of the first sheath. as well as The first hub of the first sheath is connected to the second hub of the second sheath.

12. The method of claim 11, further comprising: Remove the stitching pad from the first hub; as well as The suture pad is positioned distal to the distal end of the first sheath, around the second sheath.

13. The method of claim 12, further comprising: The suture pad is connected to the second sheath using a clip.

14. The method according to any one of claims 11 to 13, further comprising: Lock the second sheath to the elongated shaft.

15. The method according to any one of claims 11 to 14, further comprising: The position of the blood pump is adjusted by engaging the elongated shaft with a sleeve connected to the second hub and advancing the elongated shaft relative to the second sheath.

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