Catheter Fixation Device

The adapter with flexible seals and locking mechanisms secures medical devices on catheters, addressing migration issues and maintaining sterility, ensuring precise positioning and reducing disruptive adjustments.

JP2025515723APending Publication Date: 2025-05-20ABIOMED INC
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Patent Information

Application Number
JP2024566295
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-05-12
Filing Date
2023-05-11
Publication Date
2025-05-20

AI Technical Summary

Technical Problem

Medical devices positioned at the distal end of a catheter often migrate due to their larger diameter, making it difficult to maintain accurate positioning and sterility, and correcting the position using fluoroscopy is time-consuming and disruptive.

Method used

An adapter with a housing and flexible seals that can transition between open and closed configurations to secure the catheter, using locking mechanisms and attachment mechanisms to prevent axial movement, ensuring the device remains in place while maintaining sterility.

Benefits of technology

The adapter effectively secures medical devices, preventing migration and allowing for precise positioning without disrupting treatment, while maintaining sterility and reducing the need for time-consuming adjustments.

✦ Generated by Eureka AI based on patent content.

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Abstract

An adapter for securing a catheter may include a housing comprised of first and second housing parts and a locking mechanism, and a first flexible seal coupled to the first and second housing parts. The adapter has an "open" configuration in which the first flexible seal can be repositioned axially along a first catheter, cannula, or sheath having a first outer diameter. The adapter also has a "closed" configuration in which the first flexible seal cannot be repositioned axially along the first catheter, cannula, or sheath without substantially deforming the first catheter, cannula, or sheath. The first flexible seal is configured to circumferentially surround an axial portion of only the first catheter, cannula, or sheath. The adapter may be coupled to a sheath hub to prevent at least axial movement of the adapter relative to the sheath hub.
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Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 341,261, filed May 12, 2022, the contents of which are incorporated by reference in their entirety into this specification.

[0002] Technical Field FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to the field of catheter fixation, and more particularly to preventing migration of a medical device using a catheter after the medical device has been properly positioned by a physician. [Background technology]

[0003] background

[0003] Medical devices for treating patients often need to be positioned accurately in the patient's body to be effective and minimize the risk of complications. Such devices may be positioned at the distal end of a catheter, where the diameter of the device is larger than the catheter. To position such devices in a patient, a physician may first insert an introducer sheath and then insert the device through the introducer sheath to the correct position. Depending on the need for treatment, it may be necessary to remove the introducer sheath and add a repositioning sheath. It is very difficult to keep the medical device in the correct position relative to the patient and maintain sterility. If the device moves, the position can be corrected using a fluoroscopy device, but this is time-consuming and may interfere with treatment. Summary of the Invention [Means for solving the problem]

[0004] overview

[0004] An adapter for securing a catheter is disclosed. The adapter may include a housing including a first housing portion coupled to a second housing portion. The housing may also include a locking mechanism. The adapter may include a first flexible seal coupled to the first housing portion and the second housing portion. The housing may have a first ("open") configuration in which the first flexible seal can be axially repositioned along a first catheter, cannula, or sheath having a first outer diameter, and a second ("closed") configuration in which the first flexible seal cannot be axially repositioned along the first catheter, cannula, or sheath without substantially deforming the first catheter, cannula, or sheath. The first flexible seal may be configured to circumferentially surround only a portion of the first catheter, cannula, or sheath.

[0005] In some embodiments, an end of the first housing portion may be hinged to an end of the second housing portion. In some embodiments, an inner surface of the first housing portion may be slidably coupled to an outer surface of the second housing portion. In some embodiments, the first flexible seal may be comprised of a thermoplastic elastomer or a synthetic rubber. In some embodiments, the first flexible seal may be comprised of silicone or polyisoprene.

[0006] In some embodiments, the adapter may include a second flexible seal coupled to the first housing portion and the second housing portion. The second flexible seal may be capable of being axially repositioned along the second catheter, cannula, or sheath when the housing is in the first configuration. The second flexible seal may not be capable of being axially repositioned along the second catheter, cannula, or sheath when the housing is in the second configuration without substantially deforming the second catheter, cannula, or sheath. The second catheter, cannula, or sheath may have a larger outer diameter than the first catheter, cannula, or sheath. The second flexible seal may be configured to circumferentially surround a portion of both the first catheter, cannula, or sheath and the second catheter, cannula, or sheath.

[0007] In some embodiments, the first catheter, cannula, or sheath has an outer diameter of 1-4 mm, and the second catheter, cannula, or sheath (if present) has an outer diameter of 4-8 mm.

[0008] In some embodiments, the adapter may include an attachment mechanism configured to allow the housing to be coupled to the sheath hub and to prevent the adapter from moving relative to the sheath hub. In some embodiments, the attachment mechanism may be configured to be removably coupled to the sheath hub. In some embodiments, the attachment mechanism may include a protrusion or recess on a surface of the first housing portion configured to interface with a recess or protrusion on an outer surface of the sheath hub.

[0009]

[0009] In some embodiments, the locking mechanism includes a depressible tab on one of the first housing portion or the second housing portion configured to fit into a slot in the other of the first housing portion or the second housing portion.

[0010]

[0010] A system is also disclosed that may include an adapter as disclosed herein, an introducer sheath including a sheath hub coupled to the adapter, and an intravascular blood pump including a catheter in contact with the first flexible seal, wherein the catheter cannot slide axially relative to the adapter when the adapter is in a closed configuration.

[0011]

[0011] In some embodiments, the system may include an intravascular blood pump including an adapter as disclosed herein and a catheter in contact with a first flexible seal, where the catheter cannot slide axially relative to the adapter when the adapter is in a closed configuration, and a repositioning sheath positioned around the catheter and having a portion in contact with the second flexible seal.

[0012]

[0012] A kit is also disclosed. The kit may include an adapter as disclosed herein, an intravascular blood pump including a catheter, and an introducer sheath including a sheath hub. In some embodiments, the kit may also include a repositioning sheath.

[0013]

[0013] A method of securing a catheter is also disclosed. The method may include positioning an adapter including a housing and a first flexible seal relative to a sheath hub of an introducer sheath and an intravascular blood pump including a first catheter such that the housing is interactive with the sheath hub and the first flexible seal is interactive with the first catheter. The housing may include a first housing portion coupled to a second housing portion and may include a locking mechanism. The method may include reconfiguring the adapter from a first configuration to a second configuration when the adapter, the sheath hub, and the first catheter are correctly positioned. In the second configuration, the housing prevents the adapter from moving relative to the sheath hub and the first flexible seal circumferentially surrounds a portion of the first catheter to prevent the first catheter from moving relative to the adapter.

[0014] In some embodiments, prior to positioning the adapter, the method may include positioning a distal end of an introducer sheath within the patient, inserting an intravascular blood pump through the introducer sheath, and positioning the intravascular blood pump at a desired location within the patient. The first catheter may extend proximally beyond the proximal end of the sheath hub.

[0015] In some embodiments, the method may include positioning a distal end of an introducer sheath within a patient, attaching an adapter to a sheath hub, inserting an intravascular blood pump through the introducer sheath prior to reconfiguring the adapter from a first configuration to a second configuration, and positioning the intravascular blood pump at a desired location within the patient. The first catheter may extend proximally beyond the proximal end of the sheath hub.

[0016] In some embodiments, the method may include reconfiguring the adapter from the second configuration to the first configuration and decoupling the adapter from the sheath hub. In some embodiments, the method may include removing the introducer sheath from the patient. In some embodiments, the method may include inserting the repositioning sheath into the patient by sliding the repositioning sheath over the first catheter. In some embodiments, the method may include reconfiguring the adapter from the first configuration to the second configuration when the adapter, the repositioning sheath, and the first catheter are correctly positioned, the second configuration being configured such that the second flexible seal circumferentially surrounds the first catheter and a portion of the repositioning sheath to prevent the adapter from moving relative to the repositioning sheath and the first flexible seal circumferentially surrounds only a portion of the first catheter to prevent the first catheter from moving relative to the adapter. [Brief description of the drawings]

[0017] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1]1 is a simplified embodiment of an adapter. [Figure 2A]

[0018] 1 illustrates an embodiment of an adapter in an open configuration. [Figure 2B]

[0019] 1A and 1B are views of an embodiment of an adapter in a closed configuration. [Figure 3A]

[0020] FIG. 13 is a side view of an embodiment of an adapter in an open configuration. [Figure 3B]

[0021] FIG. 13 illustrates a top view of an embodiment of an adapter in an open configuration. [Figure 3C]

[0022] FIG. 13 is a side view of an embodiment of an adapter in a closed configuration. [Figure 3D]

[0023] FIG. 13 illustrates a top view of an embodiment of an adapter in a closed configuration. [Figure 4]

[0024] FIG. 1 illustrates an introducer sheath with a sheath hub, an intravascular blood pump with a catheter, and an adapter coupled to a repositioning sheath. [Diagram 5]

[0025] 1 is a flow chart of one embodiment of a method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Detailed Description

[0026] Adapters, systems, kits, and methods for securing catheters and medical devices while maintaining sterility are disclosed.

[0019]

[0027] 1, an adapter 100 can be seen. The adapter can include a housing 110. In some embodiments, the housing has an exterior surface 111 and an interior surface 112 with a wall therebetween. The housing can have a first housing portion 115 coupled to a second housing portion 116. The housing can include a locking mechanism 120.

[0020]

[0028] In some embodiments, the housing can be formed of a rigid material, such as 304 stainless steel. In some embodiments, the housing can be formed of other rigid metals, such as 316 stainless steel, or rigid polymers, such as polyetheretherketone ("PEEK"), acrylonitrile butadiene styrene ("ABS"), or polycarbonate. In some embodiments, the housing can be coated, in whole or in part, with a polymer or the like.

[0021]

[0029] In some embodiments, the adapter can have a first flexible seal 130 coupled to the first housing portion 115 and the second housing portion 116. In some embodiments, the flexible seal 130 is coupled to the housing inner surface 112, i.e., the inner surface of the first housing portion and the inner surface of the second housing portion.

[0022]

[0030] The housing can have a first configuration in which the first flexible seal 130 is repositionable axially 325 along a catheter, cannula, or sheath 320 having an outer diameter 321, and a second configuration in which the first flexible seal is not repositionable axially along the catheter, cannula, or sheath without substantially deforming or damaging the catheter, cannula, or sheath. In some embodiments, the catheter, cannula, or sheath 320 is coupled to a medical device 310, such as a blood pump.

[0023]

[0031] In some embodiments, the flexible seal can be configured to circumferentially surround only a portion of the catheter, cannula, or sheath 320. In some embodiments, the flexible seal can utilize a thermoplastic elastomer or synthetic rubber. In some embodiments, the flexible seal can include silicone or polyisoprene.

[0024]

[0032] In some embodiments, the adapter can include an attachment mechanism 150. The attachment mechanism can be configured to allow the housing 110 to be coupled to the sheath 200. In particular, the attachment mechanism can be configured to couple the housing 110 to the sheath hub 210 and prevent the adapter 100 from moving relative to the sheath hub 210. The distal end of the sheath hub 210 can be attached to the proximal end of the sheath cannula 220 such that the sheath 200 is configured to slidably receive the catheter, cannula, or sheath 320 (through a lumen extending from the proximal end 201 to the distal end 202). In some embodiments, the adapter can only be prevented from moving axially 325 relative to the sheath hub. In some embodiments, the adapter can be prevented from moving axially and circumferentially relative to the sheath hub.

[0025]

[0033] In some embodiments, the attachment mechanism 150 can be configured to be removably coupled to the sheath hub 210. In some embodiments, the attachment mechanism can be coupled to the sheath hub via, for example, a pressure sensitive adhesive.

[0026]

[0034] In some embodiments, the attachment mechanism 150 can include a recess or extrusion 151 on a surface of the first housing portion configured to interface with a matching extrusion or recess 215 on the outer surface of the sheath hub. In some embodiments, the extrusion on the surface of the sheath hub can be configured to fit through a slot or opening that extends from the inner surface to the outer surface of the housing.

[0027]

[0035] In some embodiments, the sheath cannula 220 of the sheath 200 extends below the surface 500 of the patient's skin and may extend into the patient's vascular system (not shown).

[0028]

[0036] The adapter locking mechanism 120 may be any suitable locking mechanism. As shown in FIG. 1, the locking mechanism may include one or more pins 125 configured to extend from an inner surface 112 of the first and / or second housing portion toward the other housing portion where it may interact with the other housing portion.

[0029]

[0037] 2A and 2B, in some embodiments, the locking mechanism 120 can include a tab 121 on one of the housing parts (here, the tab is shown on the second housing part 116) that is configured to mate with a recess or slot 122 on the other housing part (here, the recess or slot is shown on the first housing part 115). In some embodiments, the recess or slot can be on an extension 123 that extends from one housing part (here, the first housing part) toward the other housing part (here, the second housing part). In some embodiments, the locking mechanism can include a depressible tab (e.g., tab 121) on one of the first housing part or the second housing part that is configured to mate with a slot 122 on the other of the first housing part or the second housing part.

[0030]

[0038] 2A illustrates one configuration (e.g., an "open" configuration) of adapter 100. In this open configuration, adapter 100 is configured to have two housing portions 115, 116 connected via a hinge 117. That is, in some embodiments, an end of a first housing portion is hinged to an end of a second housing portion.

[0031]

[0039] In this open configuration, the adapter can be repositioned along or around the catheter, cannula, or sheath 320 and the sheath hub 210. As seen in FIG. 2A, there may be a recess 215 from the outer surface 211 of the sheath hub configured to interact with a protrusion 118 on the inner surface 112 of the housing. In some embodiments, the one or more protrusions may be present on one of the two housing portions, such as the first housing portion 115. In some embodiments, the one or more protrusions may be present on the inner surface of both housing portions.

[0032]

[0040] Additionally, there may be an inner surface 131 of the flexible seal 130 configured to interact with an outer surface 321 of the catheter, cannula, or sheath 320. In the open configuration, the flexible seal may not contact the catheter, cannula, or sheath 320, or may only partially surround the catheter, cannula, or sheath.

[0033]

[0041] In Figure 2B, an alternative configuration (e.g., a "closed" configuration) is shown. As can be seen, in this configuration, the locking mechanism 120 can be engaged to prevent the two housing portions from easily separating. As can be seen, in the closed configuration, the flexible seal 130 substantially surrounds the catheter, cannula, or sheath 320. This creates a frictional force on the catheter, cannula, or sheath to hold it in place.

[0034]

[0042] Additionally, protrusions 118 interact with slots or recesses 215 on the sheath hub. Given the interaction of the flexible seal with the catheter and the interaction of protrusions 118 with recesses 215 in the sheath hub, the adapter cannot move, at least axially, and the catheter cannot be adjusted, at least axially, relative to the sheath hub. By releasing the locking mechanism and returning the adapter to the open configuration - see FIG. 2A - the catheter can be repositioned as needed.

[0035]

[0043] In some embodiments, the initial configuration can be a closed configuration, i.e., a user must manipulate the housing to change the adapter to the open configuration, e.g., to reposition a catheter, cannula, or sheath. If the housing is not manipulated, the adapter returns to the closed configuration. This can be done, for example, using springs, elastomers, etc., as will be appreciated by those skilled in the art.

[0036]

[0044] 3A-3D, different locking mechanisms can be seen. In these figures, the inner surface of the first housing part may be slidably coupled to the outer surface of the second housing part. In some embodiments, the reverse may also be true - the inner surface of the second housing part may be slidably coupled to the outer surface of the first housing part.

[0037]

[0045] In Figures 3A and 3B, the "open" configuration of the locking mechanism is seen. Figure 3A shows a rotated side view and Figure 3B shows a top view of the arrangement. In some embodiments, the adapter may be configured such that in the open configuration, when viewed from above, the flexible seal 130 forms a "C" shape around the catheter, cannula, or sheath 320. The flexible seal 130 may be configured such that the separation distance 126 from the inner surface 131 of the flexible seal to the outer surface 321 of the catheter, cannula, or sheath is at least 0.1, 0.2, 0.3, 0.4, or 0.5 mm to 0.6, 0.7, 0.8, 0.9, or 1 mm (including all combinations and subranges thereof), with equal separation distances on opposite sides of the catheter, cannula, or sheath.

[0038]

[0046] In some embodiments, the flexible seal may be configured such that in the open configuration, there is a minimum clearance distance 127 from an inner surface of the portion of the flexible seal coupled to the first housing portion 115, in a direction perpendicular to the inner surfaces, to an opposing inner surface of the portion of the flexible seal coupled to the second housing portion 116. The clearance distance 127 may be from 3.5 mm, 4 mm, or 4.5 mm to 5 mm, 5.5 mm, or 6 mm, including all combinations and subranges thereof.

[0039]

[0047] As seen in FIG. 3A, the locking mechanism may include one or more tabs or teeth 121 configured to interact with one or more recesses 122, 124. In some embodiments, in the open configuration, the tabs or teeth 121 are configured to interact with a first set of recesses 122 of the housing portions. In some embodiments, the tabs or teeth on one of the housing portions may be configured to readily permit movement toward the other housing portion, but prevent movement away from the other housing portion. In some embodiments, movement separating the first housing portion from the second housing portion may occur only when one side 119 of the housing portions is squeezed or compressed.

[0040]

[0048] In some embodiments, the locking mechanism may allow the housing to enter the closed configuration when the tabs or teeth are moved into engagement with the second set of recesses 124 .

[0041]

[0049] The closed configuration can be seen in Figures 3C and 3D, where a side view (Figure 3C) and a top view (Figure 3D) are shown. As can be seen, in some embodiments, in the closed configuration, the flexible seal 130 circumferentially surrounds an axial portion of the catheter, cannula, or sheath 320. In some embodiments, an inner surface 131 of the flexible seal coupled to the first housing portion 115 is in contact with at least a portion of an inner surface of the flexible seal coupled to the second housing portion 116. As can be seen in Figure 3D, in some embodiments, the portion of the flexible seal 130 where one inner surface is in contact with another inner surface may be located between the catheter, cannula, or sheath and the locking mechanism 120.

[0042]

[0050] In some embodiments, in the closed configuration, the inner surface 131 of the flexible seal 130 may be in direct contact with substantially all (e.g., 95% or more) of the outer surface 321 of the catheter, cannula, or sheath 320 that the flexible seal circumferentially surrounds.

[0043]

[0051] With reference to FIG. 4, in some embodiments, the adapter 100 can include a second flexible seal 140 configured in a similar manner as the first flexible seal 130 .

[0044]

[0052] 4, with two flexible seals, the adapter 100 can be used to prevent axial movement of two catheters having different outer diameters relative to the sheath hub 210. Thus, in some embodiments, the second flexible seal 140 can be configured to hold a second catheter, cannula, or sheath 400 having an outer diameter 402 that is different from the diameter 321 of the catheter, cannula, or sheath 320 that the first flexible seal 130 is configured to hold.

[0045]

[0053] The second flexible seal may be axially repositionable along the second catheter, cannula, or sheath when the housing is in the open configuration and may not be axially repositionable along the second catheter, cannula, or sheath without substantially deforming the second catheter, cannula, or sheath when the housing is in the closed configuration.

[0046]

[0054] In some embodiments, the second catheter, cannula, or sheath may have a larger outer diameter than the first catheter, cannula, or sheath, hi some embodiments, the first catheter, cannula, or sheath 320 may have an outer diameter 321 between 1-4 mm and the second catheter, cannula, or sheath 400 may have an outer diameter 402 between 4-8 mm.

[0047]

[0055] In some embodiments, the second catheter, cannula, or sheath 400 extends partially through the second flexible seal 140. In some embodiments, the second catheter, cannula, or sheath 400 extends completely through the second flexible seal 140. In some embodiments, the distal end 401 of the second catheter, cannula, or sheath 400 may be positioned proximally from the first flexible seal 130, while the first catheter, cannula, or sheath 320 extends through the second flexible seal 140, the first flexible seal 130, the sheath hub 210, and the sheath cannula 220. In some embodiments, the adapter can be configured such that in a closed configuration, the second catheter, cannula, or sheath 400 has a portion 141 positioned around the first catheter, cannula, or sheath 320, with the portion 141 in contact with the second flexible seal 140.

[0048]

[0056] In some embodiments, the sheath 200 may be an introducer sheath, the first catheter, cannula, or sheath 320 may be a catheter for a medical device such as an intravascular blood pump that includes a catheter, and the second catheter, cannula, or sheath 400 may be a repositioning sheath.

[0049]

[0057] 1, in some embodiments, a system may be provided. The system may include an embodiment of an adapter 100 as disclosed herein. The system may also include an introducer sheath 200 including a sheath hub 210. The sheath hub may be coupled to the adapter as disclosed herein. The system may also include an intravascular heart pump 300 including a catheter 320, the catheter in contact with the first flexible seal 130 and non-slidable axially 325 relative to the adapter when the adapter is in a closed configuration.

[0050]

[0058] 4, in some embodiments, a system utilizing a repositioning sheath may be provided. Specifically, in some embodiments, the system may include an embodiment of the adapter 100 as disclosed herein. The system may also include an intravascular heart pump 300 including a catheter 320, the catheter being in contact with the first flexible seal 130 and being axially non-slidable relative to the adapter when the adapter is in a closed configuration. The system may also include a repositioning sheath 400 positioned around the catheter and having a portion 141 in contact with the second flexible seal 140.

[0051]

[0059] In some embodiments, the second flexible seal can be configured to circumferentially surround portion 141 of both the first catheter, cannula, or sheath and the second catheter, cannula, or sheath.

[0052]

[0060] In some embodiments, a kit is provided. With reference to FIG. 4, in some embodiments, the kit may include an embodiment of the adapter 100 as disclosed herein. The kit may also include an intravascular blood pump 300 including a catheter 320. In some embodiments, the blood pump 310 is disposed distal to the catheter 320. In some embodiments, the kit may include an introducer sheath 200 including a sheath hub 210. In some embodiments, the kit may include a repositioning sheath 400.

[0053]

[0061] In some embodiments, a method of anchoring a catheter can be provided. As seen in FIG. 5, a method 500 can include positioning 510 a distal end of an introducer sheath within a patient, the distal end of the introducer sheath having a sheath hub at a proximal end of the sheath.

[0054]

[0062] In some embodiments, the method 500 may also include inserting 520 an intravascular blood pump including a first catheter through the introducer sheath and positioning the intravascular blood pump at a desired location within the patient. The first catheter may extend proximally beyond the proximal end of the sheath hub.

[0055]

[0063] In some embodiments, the method 500 may include positioning 530 an embodiment of an adapter as disclosed herein relative to a sheath hub of the introducer sheath and an intravascular blood pump such that a housing of the adapter may be interactable with the sheath hub and a first flexible seal of the adapter may be interactable with the first catheter. The housing may include a first housing portion coupled to a second housing portion and may include a locking mechanism.

[0056]

[0064] In some embodiments, the method may include attaching 540 the adapter to the sheath hub. In some embodiments, this occurs before the inserting step 520. In some embodiments, this occurs after the inserting step 520.

[0057]

[0065] The method 500 may also include reconfiguring 550 the adapter from the first configuration to a second configuration when the adapter, sheath hub, and first catheter are correctly positioned. As disclosed herein, the second configuration may be configured such that the housing prevents the adapter from moving at least axially relative to the sheath hub and the first flexible seal circumferentially surrounds an axial portion of the first catheter to prevent the first catheter from moving relative to the adapter (e.g., via frictional forces).

[0058]

[0066] In some embodiments, the method 500 can include reconfiguring 560 the adapter from a closed configuration to an open configuration. In some embodiments, this can also include removing the adapter from the sheath hub.

[0059]

[0067] In some embodiments, the method 500 may include removing 570 the introducer sheath from the patient.

[0060]

[0068] In some embodiments, the method 500 may include inserting 580 a repositioning sheath into the patient by sliding the repositioning sheath over the first catheter.

[0061]

[0069] In some embodiments, the method 500 may include reconfiguring 590 the adapter from an open configuration to a closed configuration when the adapter, the repositioning sheath, and the first catheter, cannula, or sheath are correctly positioned. As disclosed herein, the closed configuration may be configured such that the second flexible seal may circumferentially surround a portion of both the first catheter, cannula, or sheath and the repositioning sheath, and prevent the adapter from moving relative to the repositioning sheath. The first flexible seal may also circumferentially surround only a portion of the first catheter, cannula, or sheath, preventing the first catheter from moving relative to the adapter.

[0062]

[0070] The embodiments of the present disclosure will be described in detail with reference to the figures in which like reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for claims and as a representative basis for teaching those skilled in the art to employ the present disclosure in various ways in substantially any appropriately detailed structure.

[0063]

[0071] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein which equivalents are intended to be encompassed by the following claims.

Claims

1. a housing including a first housing portion coupled to a second housing portion, the housing including a locking mechanism; a first flexible seal coupled to the first housing portion and the second housing portion; Including, the housing has a first configuration in which the first flexible seal can be axially repositioned along a first catheter, cannula, or sheath having a first outer diameter, and a second configuration in which the first flexible seal cannot be axially repositioned along the first catheter, cannula, or sheath without substantially deforming the first catheter, cannula, or sheath; the first flexible seal is configured to circumferentially surround only a portion of the first catheter, cannula, or sheath; adapter.

2. The adapter of claim 1 , wherein an end of the first housing portion is hinged to an end of the second housing portion.

3. The adapter of claim 1 , wherein an inner surface of the first housing portion is slidably coupled to an outer surface of the second housing portion.

4. The adapter of any one of claims 1 to 3, wherein the first flexible seal is constructed from a thermoplastic elastomer or a synthetic rubber.

5. The adapter of any one of claims 1 to 4, wherein the first flexible seal is constructed from silicone or polyisoprene.

6. a second flexible seal coupled to the first housing portion and the second housing portion; the second flexible seal is capable of being axially repositioned along the second catheter, cannula, or sheath when the housing is in the first configuration; the second flexible seal cannot be axially repositioned along the second catheter, cannula, or sheath when the housing is in the second configuration without substantially deforming the second catheter, cannula, or sheath; the second catheter, cannula, or sheath has a larger outer diameter than the first catheter, cannula, or sheath; the second flexible seal is configured to circumferentially surround a portion of both the first catheter, cannula, or sheath and the second catheter, cannula, or sheath. An adapter according to any one of claims 1 to 5.

7. The adapter of claim 6, wherein the first catheter, cannula, or sheath has an outer diameter of 1-4 mm and the second catheter, cannula, or sheath has an outer diameter of 4-8 mm.

8. The adapter of any one of claims 1 to 7, further comprising an attachment mechanism configured to enable the housing to be coupled to a sheath hub and to prevent the adapter from moving relative to the sheath hub.

9. The adapter of claim 8 , wherein the attachment mechanism is configured to be removably coupled to the sheath hub.

10. The adapter of claim 8 or 9, wherein the attachment mechanism comprises a protrusion or recess on a surface of the first housing portion configured to interface with a recess or protrusion on an outer surface of the sheath hub.

11. 11. The adapter of claim 1, wherein the locking mechanism comprises a depressible tab on one of the first housing part or the second housing part configured to mate with a slot in the other of the first housing part or the second housing part.

12. An adapter according to any one of claims 1 to 11; an introducer sheath including a sheath hub, the sheath hub coupled to the adapter; an intravascular blood pump including a catheter, the catheter contacting the first flexible seal and unable to slide axially relative to the adapter when the adapter is in a closed configuration; A system including:

13. An adapter according to any one of claims 1 to 11; an intravascular blood pump including a catheter, the catheter contacting the first flexible seal and unable to slide axially relative to the adapter when the adapter is in a closed configuration; a repositioning sheath positioned about the catheter and having a portion in contact with the second flexible seal; A system including:

14. An adapter according to any one of claims 1 to 11; an intravascular blood pump including a catheter; an introducer sheath including a sheath hub; Kit including:

15. The kit of claim 14 further comprising a repositioning sheath.

16. 1. A method of securing a catheter, comprising: positioning an adapter including a housing and a first flexible seal relative to a sheath hub of an introducer sheath and an intravascular blood pump including a first catheter such that the housing is interactable with a sheath hub and the first flexible seal is interactable with a first catheter, the housing including a first housing portion coupled to a second housing portion, the housing including a locking mechanism; reconfiguring the adapter from a first configuration to a second configuration when the adapter, sheath hub, and first catheter are properly positioned, the second configuration being configured such that the housing prevents the adapter from moving relative to the sheath hub and the first flexible seal circumferentially surrounds a portion of the first catheter to prevent the first catheter from moving relative to the adapter. The method includes:

17. Before positioning the adapter, Positioning a distal end of the introducer sheath within a patient; and Inserting the intravascular blood pump through the introducer sheath and positioning the intravascular blood pump at a desired location within the patient. wherein the first catheter extends proximally beyond the proximal end of the sheath hub.

17. The method of claim 16.

18. Positioning a distal end of the introducer sheath within a patient; Attaching the adapter to the sheath hub; and inserting the intravascular blood pump through the introducer sheath and positioning the intravascular blood pump at a desired location within the patient prior to reconfiguring the adapter from a first configuration to a second configuration. wherein the first catheter extends proximally beyond the proximal end of the sheath hub.

17. The method of claim 16.

19. The method of claim 16 , wherein an end of the first housing portion is hinged to an end of the second housing portion.

20. The method of claim 16 , wherein an inner surface of the first housing portion is slidably coupled to an outer surface of the second housing portion.

21. The method of any one of claims 16 to 20, wherein the first flexible seal is comprised of a thermoplastic elastomer or a synthetic rubber.

22. The method of any one of claims 16 to 21, wherein the first flexible seal is constructed from silicone or polyisoprene.

23. The adapter: a second flexible seal coupled to the first housing portion and the second housing portion Further comprising: the second flexible seal is capable of being axially repositioned along the second catheter, cannula, or sheath when the housing is in the first configuration; the second flexible seal cannot be axially repositioned along the second catheter, cannula, or sheath when the housing is in the second configuration without substantially deforming the second catheter, cannula, or sheath; the second catheter, cannula, or sheath has a larger outer diameter than the first catheter, cannula, or sheath; the second flexible seal is configured to circumferentially surround a portion of both the first catheter and the second catheter, cannula, or sheath. The method according to any one of claims 16 to 22.

24. 24. The method of claim 23, wherein the first catheter, cannula, or sheath has an outer diameter of 1-4 mm and the second catheter, cannula, or sheath has an outer diameter of 4-8 mm.

25. 25. The method of any one of claims 16 to 24, wherein the adapter further comprises an attachment mechanism configured to allow the housing to be coupled to a sheath hub and to prevent the adapter from moving relative to the sheath hub.

26. The method of claim 25 , wherein the attachment mechanism is configured to be removably coupled to the sheath hub.

27. 27. The method of claim 25 or 26, wherein the attachment mechanism comprises a protrusion or extrusion on a surface of the first housing portion configured to interface with an extrusion or protrusion on an outer surface of the sheath hub.

28. 28. The method of any one of claims 16 to 27, wherein the locking mechanism comprises a depressible tab on one of the first housing part or the second housing part configured to fit into a slot in the other of the first housing part or the second housing part.

29. reconfiguring the adapter from a second configuration to a first configuration and disconnecting the adapter from the sheath hub; removing the introducer sheath from the patient; inserting the repositioning sheath into the patient by sliding the repositioning sheath over the first catheter; reconfiguring the adapter from a first configuration to a second configuration when the adapter, repositioning sheath, and first catheter are correctly positioned, the second configuration being configured such that a second flexible seal circumferentially surrounds the first catheter and a portion of the repositioning sheath to prevent the adapter from moving relative to the repositioning sheath and the first flexible seal circumferentially surrounds only a portion of the first catheter to prevent the first catheter from moving relative to the adapter; The method of any one of claims 16 to 28, further comprising: