Thin access sheath

Abstract

A system for insertion into a patient's vasculature is disclosed that employs a main tubular sheath body coupled to a distal portion of an intermediate tubular sheath body and a hub coupled to a proximal portion of the intermediate tubular sheath. The hub may be coupleable to a dilator by interaction of a dilator cap with the hub, and the hub may include a hemostatic valve comprising a foam member having one or more visually identifiable regions.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 272,750, filed October 28, 2021, and U.S. Provisional Patent Application No. 63 / 413,098, filed October 4, 2022, the entire contents of each of which are incorporated herein by reference.

[0002] Technical Field

[0002] The present disclosure relates to a non-peel-away introducer sheath assembly and dilator assembly that may enable the introduction of one or more medical devices into a patient's body at a single insertion site, such introducer sheath assembly having a hemostatic valve to reduce or eliminate the outflow of bodily fluids from the patient through the insertion site of the introducer sheath assembly. [Background technology]

[0003] background

[0003] Mechanical circulatory assist devices (e.g., intracardiac heart pump assemblies) or other medical devices may be introduced into a patient's body in a variety of ways. A common approach is to introduce the device through the vascular system either surgically or percutaneously during a cardiac procedure. When the medical device is expected to remain in the patient's body for an extended period of time, a commonly used peel-away introducer sheath may be peeled away and replaced with a smaller diameter sheath (e.g., a repositioning sheath) that is pre-attached to the medical device to reduce the risk of blood flow obstruction. Summary of the Invention [Means for solving the problem]

[0004] overview A first aspect relates to an apparatus for insertion into a patient's vasculature, wherein the apparatus includes a main tubular sheath body, an intermediate tubular sheath body connected to a proximal end of the main tubular sheath body, and a hub connected to a proximal portion of the intermediate tubular sheath body, wherein the main tubular sheath body is composed of a first material, the intermediate tubular sheath body is composed of a second material, and the hub is composed of a third material, wherein a theoretical interfacial bond strength between the first material and the second material and a theoretical interfacial bond strength between the third material and the second material both exceed a theoretical interfacial bond strength between the first material and the third material.

[0005] In some embodiments, the intermediate tubular sheath body can have a first inner diameter at its distal end and a second inner diameter spaced axially proximally from the distal end, the second inner diameter being greater than the first inner diameter. In some embodiments, the second inner diameter can be between 5 mm and 6 mm.

[0006] In some embodiments, the first material may include a polyether block amide (PEBA). In some embodiments, the second material may include a thermoplastic styrene butadiene copolymer. In some embodiments, the third material may include an acrylonitrile butadiene styrene.

[0007] In some embodiments, the main tubular sheath body can include multiple layers. These layers can include, for example, a frame layer and an outer jacket. In some embodiments, the frame layer can include Nitinol and the outer jacket can include Polyether Block Amide (PEBA).

[0008]

[0008] In some embodiments, the device may include a side port extending from the hub.

[0009] In some embodiments, the hub may include a rotatable portion that is rotatable relative to the hub, the main tubular sheath body, and the intermediate tubular sheath body, the rotatable portion being connected to a distal portion of the hub. In some embodiments, the rotatable portion may be rotatable (i.e., capable of being rotated) by at least 180 degrees. In some embodiments, the rotatable portion may be rotatable by at least 360 degrees. In some embodiments, the rotatable portion may be configured to allow a side port extending from the hub to lie against the patient. In some embodiments, the rotatable portion may include a butterfly, a suture pad, or a combination thereof.

[0010]

[0010] A second aspect relates to an apparatus including a hub, a sheath including a tubular sheath body operably coupled to the hub, a dilator body receivable through the tubular sheath body, a dilator hub coupled to a proximal end of the dilator body, and a dilator having a dilator handle coupled to a dilator cap. The hub includes one or more threads extending partially around the hub, a locking portion of each thread having a different axial thickness than different portions of the thread. The tubular sheath body extends from a proximal end to a distal end, the proximal end being operably coupled to the hub, and the dilator cap includes a groove or channel configured to receive the thread when the dilator is received through the sheath body, the groove or channel being configured with a ridge or recess adapted to engage the locking portion of the thread.

[0011] In some embodiments, the groove or channel may be configured with a ridge, and the locking portion has an axial thickness that is less than the different portions of the thread. In some embodiments, the height of the ridge or recess may be the same as the difference in axial thickness between the locking portion and the different portions.

[0012]

[0012] In some embodiments, the hub and dilator cap may each include an indicator on its outer surface configured to indicate when the groove or channel is aligned with the threads before being locked in place.

[0013]

[0013] In some embodiments, the dilator cap may define an opening extending along a central axis from the proximal surface to the distal surface, the opening having a central circular portion and one or more spokes extending outward from the central circular portion, each spoke configured to align with a ridge on the distal surface of the dilator handle.

[0014]

[0014] In some embodiments, the device is configured to provide an indication to the user that the dilator is locked in place, such as an audible sound, a vibration through the dilator handle, or a combination thereof.

[0015]

[0015] A third aspect relates to a hemostatic valve assembly including a foam member configured to at least partially secure an elastomeric member within a housing to provide structural support for a proximal end of the elastomeric member, the foam member having a proximal surface defining a first opening, the first opening extending along the longitudinal axis from the proximal surface to the distal surface of the longitudinal axis of the hemostatic valve assembly, and the foam member having at least one visually identifiable portion a predetermined distance from at least one edge of the first opening.

[0016] In some embodiments, the foam may include silicone oil. In some embodiments, the first opening may be laser cut.

[0017] In some embodiments, the at least one visually identifiable portion may include one or more additional openings extending at least partially from the proximal surface toward the distal surface. In some embodiments, each of the one or more additional openings may be equidistant from at least one edge. In some embodiments, each of the one or more additional openings may have a diameter of less than 0.5 mm. In some embodiments, the one or more additional openings may include two to four additional openings.

[0018] In some embodiments, the at least one visually identifiable portion may include a portion that is visually darker or lighter than a different portion of the foam. [Brief explanation of the drawings]

[0019] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A] FIG. 2D is a schematic diagram of one embodiment of an introducer sheath with a hemostatic valve. [Figure 1B]

[0020] FIG. 2D is a schematic diagram of one embodiment of an introducer sheath with a hemostatic valve and a dilator assembly inserted therein. [Figure 2]

[0021] FIG. 2D schematic diagram of one embodiment of a hub. [Figure 3A]

[0022] 1 is an orthogonal representation of an embodiment of a dilator cap. [Figure 3B] 1 is an orthogonal representation of an embodiment of a dilator cap. [Figure 4]

[0023] 1 is an orthogonal representation of one embodiment of a dilator handle. [Figure 5]

[0024] 10 is an orthogonal representation of one embodiment of a foam member of a hemostasis valve. [Figure 6A]

[0025] 2D representations of different embodiments of foam members. [Figure 6B]2D representations of different embodiments of foam members. [Figure 6C] 2D representations of different embodiments of foam members. [Figure 6D] 2D representations of different embodiments of foam members. [Figure 7]

[0026] 10 is a representation of yet another embodiment of a foam member. [Figure 8A]

[0027] 1 is a representation of the foam element within the hub. [Figure 8B]

[0027] A representation of the foam element within the hub. DETAILED DESCRIPTION OF THE INVENTION

[0020] Detailed Description

[0028] With respect to mechanical circulatory assist devices, peel-away introducer sheaths may be used when the device is expected to remain in the patient for an extended period of time (e.g., by peeling the introducer sheath and replacing it with a smaller diameter sheath pre-attached to the medical device). However, as it becomes more desirable to utilize a single insertion point for introducing multiple medical devices into the body, peel-away introducers may become less desirable due to the intentionally weakened sidewall strength of such introducers. Furthermore, typical peel-away introducers have a large outer diameter, which can undesirably obstruct blood flow past the introducer, potentially resulting in lower limb ischemia.

[0021]

[0029] Therefore, the inventors have realized that a low-profile, non-peel-away introducer sheath may be desirable. However, to maintain the desired characteristics of such a sheath, further modifications to the design may be required, as the dimensions cannot simply be reduced proportionately and remain usable and manufacturable.

[0022]

[0030] To that end, a low-profile, non-peel-away introducer sheath assembly that incorporates design features that enable the benefits of current non-peel-away introducer sheaths while remaining manufacturable, and a dilator assembly that can make such sheaths useful, are desired.

[0023]

[0031] 1A and 1B, a system for insertion into a patient's vasculature can be seen. The system generally includes a hub 40 operably connected to a sheath 105, the hub including a hemostatic valve 200, through which, for example, a dilator assembly 110, a heart pump, or other medical device can be inserted.

[0024]

[0032] A first aspect of the present disclosure relates to an instrument 10 for insertion into a patient's vasculature. The instrument 10 may include a main tubular sheath body 20 coupled to a distal end of an intermediate tubular sheath body 30 and a hub 40 coupled to a proximal portion of the intermediate tubular sheath body 30. The hub 40 may be connected to a side port 50. A rotatable portion 60 or member may be operably coupled to the distal end of the hub.

[0025]

[0033] Main tubular sheath body

[0034] The main tubular sheath body 20 may comprise a first material, and the main tubular sheath body may extend from a proximal end 21 to a distal end 22 .

[0026]

[0035] In some embodiments, the first material may include a polyether block amide (PEBA), such as PEBAX® elastomers sold by Arkema.

[0027]

[0036] In some embodiments, the main tubular sheath body 20 may include multiple layers: an outer jacket 23 (which may include or consist of PEBA) and an inner frame layer 24 (which may include or consist of nitinol).

[0028]

[0037] Intermediate tubular sheath body

[0038] The device may also include an intermediate tubular sheath body 30 (see FIGS. 1A and 1B) that includes or consists of a second material, and that extends from a proximal end 31 to a distal end 32. The distal end 32 of the intermediate tubular sheath body 30 may be connected to the proximal end 21 of the main tubular sheath body 20. In some embodiments, the distal end of the intermediate tubular sheath body may be butt-welded to the proximal end of the main tubular sheath body, although it should be understood that other types of joints between the main tubular sheath body and the intermediate tubular sheath body may be suitable.

[0029]

[0039] In some embodiments, the intermediate tubular sheath body 30 may include or consist of a thermoplastic styrene butadiene copolymer, such as STYROLUX® resin sold by Entec Polymers.

[0030]

[0040] In some embodiments, the intermediate tubular sheath body 30 can have a proximal portion 35 with a constant inner diameter 39 and a distal portion 33 that linearly reduces in diameter from the inner diameter 39 at the proximal portion to a smaller inner diameter 38 at the distal end 32. In some embodiments, the intermediate tubular sheath body can have a first inner diameter 38 at the distal end 32 and a second inner diameter 39 located an axial distance 34 proximal to the distal end. In some embodiments, the second inner diameter 39 can be larger than the first inner diameter. In some embodiments, the second inner diameter 39 is between 5 mm and 6 mm. In some embodiments, this inner diameter can be the same as the inner diameter of the main tubular sheath.

[0031]

[0041] Hub

[0042] The device may also include a hub 40 (see, e.g., FIG. 1A ), which may include or consist of a third material, and which may be connected to the proximal portion 35 of the intermediate sheath body 30 and separated from the main tubular sheath body 20 by the intermediate tubular sheath body 30.

[0032]

[0043] In some embodiments, the third material may be acrylonitrile butadiene styrene.

[0033]

[0044] In some embodiments (see, e.g., FIGS. 1A and 1B), the inner surface 41 of the hub 40 may be connected to a portion of the outer surface 36 of the intermediate tubular sheath body 30 and not connected to the main tubular sheath body 20. In some embodiments, the hub is connected only to the proximal portion 35 of the intermediate tubular sheath body 30 at a constant diameter 39 and not to the distal portion 33, which reduces in diameter to a smaller inner diameter.

[0034]

[0045] Because the hub requires different properties than the main tubular sheath body, the materials comprising each of these sections are necessarily different, and these differences often result in the two components not being able to bond effectively. Therefore, in some embodiments, an intermediate layer aids bonding by allowing the two components to bond more effectively than they would bond to each other. Therefore, in the present disclosure, the first material, second material, and third material may be configured such that the theoretical interfacial bond strength between the first material and the second material and the theoretical interfacial bond strength between the third material and the second material are both greater than the theoretical interfacial bond strength between the first material and the third material. As known in the art, interfacial bond strength (IBS) is the strength of the bond between two layers at an interface and can be tested, for example, by tensile or shear testing, although tensile testing is more commonly used.

[0035]

[0046] Side Port

[0047] 1A and 1B, the device may also include a side port 50 extending from the hub 40. A first end 51 of the side port 50 may be connected to an inlet 44 defined by the outer surface 42 of the hub 40, which extends to the inner surface 41 of the hub 40.

[0036]

[0048] Rotating part

[0049] The device may also include a rotatable portion 60 (see, e.g., FIG. 1A) that is rotatable relative to the main tubular sheath body 20 about a central axis. In some embodiments, the intermediate tubular sheath body 30, the hub 40, and the rotatable portion may be connected to a distal portion of the hub 40.

[0037]

[0050] In some embodiments, the rotatable portion 60 may be permanently attached (or not easily removable), for example, via a plurality of snap-fit ​​joints 61. In some embodiments, the rotatable portion may include a butterfly, a suture pad, or a combination thereof.

[0038]

[0051] In some embodiments, the rotatable portion 60 can be rotatable at least 180 degrees about a central axis (in FIGS. 1A and 1B, the central axis is the centerline of the main tubular sheath body 20 and the intermediate tubular sheath body 30). For example, in some embodiments, the rotatable portion (when attached to a patient) can still rotate the hub so that (minimally) the side port can be oriented toward the patient's right side or toward the patient's left side. In some embodiments, the rotatable portion 60 can be rotatable at least 360 degrees about the central axis, including being freely rotatable without restriction.

[0039]

[0052] In some embodiments, the rotatable portion 60 can be configured to allow the side port 50 extending from the hub 40 to lie substantially flat against the patient, regardless of the orientation of the rotatable portion 60 on the patient's body. For example, in some embodiments, the side port can be easily placed substantially flat against the patient by being able to rotate the hub so that the inlet 44 of the hub to which the side port 50 connects is pointed towards (or at least not away from) the patient's body.

[0040]

[0053] In some embodiments, the rotatable portion 60 can be configured to surround the portion of the device 10 where some or all of the intermediate tubular sheath body 30 is positioned, as well as surround the connection point between the main tubular sheath body 20 and the intermediate tubular sheath body 30 (e.g., surround at least a portion of the proximal end of the tubular sheath body 20).

[0041]

[0054] Also disclosed is a device (or system) 100. In some embodiments, the device 100 includes a hub 40, a sheath 105, and a dilator 110.

[0042]

[0055] Hub

[0056] Referring to FIG. 2, a hub 40 can be seen having a distal end 46 and a proximal end 47. The hub 40 can include one or more threads 43 (two threads are shown in FIG. 2 by way of example), with each thread extending at least partially around the circumference of the hub 40. As will be appreciated, in other embodiments, the threads can have other suitable arrangements. As shown in FIG. 2, the threads 43 can be located on a proximal portion 101 of the hub 40 at or near the proximal end 47.

[0043]

[0057] 2, in some embodiments, each thread may have portions with different axial thicknesses (e.g., thread thickness in the axial direction). For example, in one embodiment, each thread 43 has a first locking portion 104 with a first axial thickness 49, which may be different from a second axial thickness 48 in a second portion 103 of each thread 43.

[0044]

[0058] In some embodiments, the first axial thickness 49 of the locking portion 104 may be less than the second axial thickness 48 of the second portion 103. In some embodiments, the first axial thickness 49 of the locking portion 104 may be greater than the second axial thickness 48 of the second portion 103.

[0045]

[0059] In some embodiments, each thread may have one locking portion 104 and one second portion 103. In some embodiments, each thread may have one locking portion 104 and two second portions 103 (one on each side of the locking portion).

[0046]

[0060] In some embodiments, the interface 106 between the locking portion 104 and the second portion 103 can extend non-radially. In some embodiments, the interface 106 between the locking portion 104 and the second portion 103 can extend radially.

[0047]

[0061] The hub 40 may also include indicators 107, such as shapes or designs molded or etched into or on the outer surface of the hub, to aid in alignment of the hub 40 and the dilator 110.

[0048]

[0062] sheath

[0063] 1B, device 100 may also include a sheath 105. Sheath 105 may include a main tubular sheath body 20 extending from a proximal end 21 to a distal end 22. In some embodiments, proximal end 21 may be operably coupled to a hub 40, for example, via an intermediate tubular sheath body 30 as previously described.

[0049]

[0064] Dilator

[0065] The device 100 may also include a dilator 110 (see, e.g., FIG. 1B ). The dilator 110 may include a dilator body 120 receivable through the tubular sheath body 20 and a dilator hub 125 coupled to a proximal portion of the dilator body 120. The dilator hub 125 may include or consist of a dilator cap 130 and a dilator handle 140. In some embodiments, the dilator handle 140 may be coupled to a proximal surface of the dilator cap 130.

[0050]

[0066] 3A , the dilator cap 130 may include at least one groove or channel 131 configured to receive the one or more threads 43 on the hub 40 when the dilator body 120 is received through the main tubular sheath body 20. In this regard, the size and shape of the at least one groove or channel 131 may correspond to the size and shape of the one or more threads 43 on the hub 40.

[0051]

[0067] In some embodiments, one or more of the grooves or channels 131 can be configured with ridges or depressions 132 adapted to engage with locking portions 104 of the threads 43. In some embodiments, all of the grooves or channels 131 can be configured with ridges or depressions 132 adapted to engage with respective locking portions of respective threads. In some embodiments, the grooves or channels 131 can be configured with ridges 132, and a first axial thickness of the locking portion is thinner than a second portion of the thread (e.g., to allow engagement of the ridges or depressions with the locking portion).

[0052]

[0068] In some embodiments, the dilator cap 130 may also include an indicator 136, such as a shape or design molded or etched into or on the outer surface of the dilator cap 130, to aid in alignment of the hub 40 and the dilator 110 (more specifically, alignment of the dilator cap and the hub). In some embodiments, the hub 40 and the dilator cap 130 may each include an indicator (107, 136) configured to indicate when the groove or channel is aligned with the threads before being locked in place. In some embodiments, the hub 40 and the dilator cap 130 may each include an indicator (107, 136) configured to indicate when the groove or channel is locked into a locked position. In some embodiments, the dilator cap 130 may include one indicator (136) and the hub may include two indicators (107), both of which are configured to indicate when the groove or channel is aligned with the threads before being locked into a locked position, and also when the groove or channel is locked into a locked position.

[0053]

[0069] The dilator cap 130 can be configured such that any ridge or depression 132 has an axial height equal to or substantially equal to the difference in height between the locking portion 104 and the second portion(s) 103.

[0054]

[0070] The dilator 110 can be configured to provide an indication, such as an invisible indication, to the user that the dilator is locked in place (e.g., locked onto the hub). By configuring the dimensions and composition of components such as the dilator cap 130, the dilator can be configured to produce, for example, an audible sound. For example, the dilator cap can produce a noticeable "click" sound, a vibration through the dilator handle, or a combination thereof, when the dilator is locked in place. Other indicia may be used as needed to indicate the locking status of the dilator.

[0055]

[0071] In some embodiments, the dilator cap 130 has a proximal surface 137 that defines an opening 133 extending from the proximal surface 137 to the distal surface 138 of the dilator cap (see, e.g., FIG. 3A ). The opening 133 may be circular or substantially circular in shape, and the center of the opening may be aligned with a centerline 135 of the dilator cap 130. In some embodiments, the diameter of the opening 133 may be, for example, 7-8 mm. The proximal surface 137 may also define one or more “spoke” or “wing” channels 134 extending outward from the central opening 133. In this regard, the spoke or wing channels 134 are additional openings defined by the proximal surface that extend from the proximal surface 137 to the distal surface 138.

[0056]

[0072] In some embodiments, the central opening 133 can have an inner surface 150 that includes a straight cut side extending axially (e.g., parallel to the central axis 135) from the proximal surface 137 to the distal surface 138. In some embodiments, the proximal edge 151 of the inner surface 150 of the central opening can be shaped to facilitate assembly. Referring to FIG. 3B , the inner surface 150 of the central opening 133 can also include a chamfer 152 at the proximal surface 137 (e.g., at least a portion of the proximal edge can be chamfered). In such embodiments, the inner surface of the central opening 133 can be rounded at the proximal surface 137 (e.g., at least a portion of the proximal edge can be rounded).

[0057]

[0073] In some embodiments, additional text or images may be provided on the proximal surface 137. For example, in some embodiments, one or more words or icons are embossed on the proximal surface. In some embodiments, such words or icons provide the user with directional or usage instructions (e.g., "twist" or "push"), or information regarding the size of the dilator opening (e.g., "14F" to indicate that the dilator is a 14 French dilator).

[0058]

[0074] In some embodiments, the spoke or wing channels 134 can help align the dilator handle 140 with the dilator cap 130. In some embodiments, the spokes or wings 134 can help transfer force from the handle to the cap, for example, when the handle and cap are coupled together.

[0059]

[0075] In some embodiments, there may be a single spoke or wing channel 134. In some embodiments, the distal cap 130 includes two to four spoke or wing channels 134. In some embodiments, the spoke or wing channels 134 are symmetrically arranged around the central opening 133. In some embodiments, each spoke or wing channel 134 may extend radially the same distance 139 from the edge of the central opening 133 toward the outer edge of the proximal face. In some embodiments, each spoke or wing channel may have the same size and shape. As will be appreciated, the spoke or wing channels may have a size and shape that corresponds to a corresponding bonding area on the dilator handle.

[0060]

[0076] 4, there is shown one embodiment of a dilator handle 140. The dilator handle 140 may include a dilator handle body 141 having a proximal end 142 and a distal end 143. The dilator handle body 141 may define a central lumen 144 extending from the proximal end 142 to the distal end 143.

[0061]

[0077] In some embodiments, the distal portion of the dilator handle may include a coupling portion 145 configured to allow the dilator handle 140 to be coupled to the dilator cap 130. In some embodiments, the coupling portion may include one or more locking extensions configured to pass through a central opening and one or more spoke or wing channels in the dilator cap. For example, in some embodiments, the coupling portion 145 includes a central extension 146 configured to pass through a central opening 133 in the dilator cap 130. The central extension 146 may include one or more locking ridges 147 configured to pass through the central opening 133 and interact with a distal surface 138 of the dilator cap to hold the dilator handle 140 relative to the dilator cap 130. In some embodiments, the distal surface of the dilator handle may include one or more additional spoke or wing extensions 148 configured to extend at least partially into the spoke or wing channels 134 when the dilator handle is connected to the dilator cap. In some embodiments, there are two to four additional spoke or wing extensions 148. In some embodiments, each additional spoke or wing extension can connect to a surface of the central extension 146. In some embodiments, each additional spoke or wing extension is configured such that when the dilator handle is connected to the dilator cap, the distal surface of each additional spoke or wing extension 148 is parallel to the distal surface 138 of the distal cap. The central axis 149 of the dilator handle 140 can be configured to align with the central axis 135 of the dilator cap 130.

[0062]

[0078] The dilator handle may include one or more threads at the proximal end 142 for accepting one or more additional dilator components through the central lumen 144 along the central axis 135.

[0063]

[0079] 1A and 1B, a hemostasis valve assembly 200 is shown. The hemostasis valve assembly generally includes a foam member 210 configured to at least partially secure an elastomeric member 220 within a housing 230 and provide structural support for a proximal end 221 of the elastomeric member 220.

[0064]

[0080] In some embodiments, the foam member 210 may include a lubricant, such as silicone oil, for example, within the pores of the foam.

[0065]

[0081] 5, it can be seen that foam member 210 has a proximal surface 211 defining a first opening 215 extending along a longitudinal axis 213 from the proximal surface 211 to the distal surface 212 of foam member 210. In some embodiments, the first opening may be laser cut.

[0066]

[0082] The foam member 210 may have at least one visibly identifiable portion 216 that is different from at least one other portion 217 on the proximal surface 211. The at least one visibly identifiable portion 216 may be a predetermined distance 218 from at least one edge of the first opening 215.

[0067]

[0083] In some embodiments, the predetermined distance is between 1 mm and 8 mm, for example, between 2 mm and 5 mm.

[0068]

[0084] In some embodiments, the at least one visually identifiable portion may include a portion that is visually darker or lighter than a different portion of the foam. In some embodiments, the at least one visually identifiable portion may include one or more additional openings extending at least partially from the proximal surface toward the distal surface. In some embodiments, the diameter of each of the one or more additional openings may be less than 0.5 mm. In some embodiments, the one or more additional openings may include two to four additional openings. In some embodiments, the at least one visually identifiable portion may include one or more additional openings extending at least partially from the proximal surface toward the distal surface and a portion that is visually darker or lighter than a different portion of the foam.

[0069]

[0085] 6A, a simplified schematic diagram of an alternative embodiment is shown in which a foam member 300 has an oval-shaped opening 301 and two additional openings 302, each extending at least partially from the proximal surface toward the distal surface. In FIG. 6A, the two additional openings are shown equidistant from the edge of opening 301.

[0070]

[0086] Referring to FIG. 6B, a simplified schematic diagram of an alternative embodiment is shown in which a foam member 305 has an oval opening 306 that is surrounded at a distance by at least one visually identifiable portion 307 that is darker than a different portion 308 closer to the oval opening 306.

[0071]

[0087] 6C, a simplified schematic diagram of an alternative embodiment is shown in which a foam member 310 has a circular opening 311 surrounded by at least one visually identifiable portion 313, 314 at different distances, where each visually identifiable portion includes additional openings 312 that respectively extend at least partially from the proximal surface toward the distal surface, and where each additional opening is surrounded by a portion 313, 314 that is visually lighter or darker (here, darker) than a different portion 315 closer to opening 311. Furthermore, one of the visually identifiable portions 314 is closer to the edge of opening 311 than another visually identifiable portion 313.

[0072]

[0088] Referring to Figure 6D, a simplified schematic diagram of an alternative embodiment that is generally the inverse of Figure 6B is shown, in which a foam member 329 has a circular opening 321 that is surrounded at a distance by at least one visibly identifiable portion 322 that is lighter than a different portion 323 closer to the oval opening 321.

[0073]

[0089] In some embodiments, the foam may include two or more pieces, which in some embodiments are adjacent to one another.

[0074]

[0090] Referring to Figure 7, in some embodiments, the foam member may have cuts 410 (which may be slits, for example) that extend at least partially, or in some cases entirely, through at least a portion of the foam member. In some embodiments, the cuts may be in only a single direction (e.g., parallel only to the x-axis). In some embodiments, the cuts may extend radially from the central axis. In some embodiments, there may be at least one cut that is perpendicular to another cut.

[0075]

[0091] In some embodiments, there may be one or more openings 420 extending through the foam and having a substantially circular cross section, which helps guide the physician to the puncture site for single access.

[0076]

[0092] In some embodiments, there may be one or more openings 430 extending through the foam that do not have a circular cross section.

[0077]

[0093] In some embodiments, the outward facing surface of the foam may be divided into quadrants, hi some embodiments, each quadrant of the foam may include one or more openings 420.

[0078]

[0094] 8A and 8B, hub 450 can be seen with foam member 400 shown in position within the hub. In some embodiments, a physician can pierce valve 460 by inserting a needle through one of openings 420 and through valve 460. In such embodiments, one or more openings can be guides to assist the physician in piercing the valve.

[0079]

[0095] While various aspects described herein relate to sheath designs that are particularly suitable for simultaneous use of multiple medical devices (e.g., via a single access technique), it should be understood that the sheath technology of the present disclosure is not limited to use with multiple medical devices, and that the sheath technology of the present disclosure may also provide advantages when used with a single device (e.g., when used solely to provide access for an intravascular blood pump or other suitable medical device).

[0080]

[0096] 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. 1. An instrument for insertion into the vasculature of a patient, said instrument comprising: a main tubular sheath body comprising a first material, the main tubular sheath body extending from a proximal end to a distal end; an intermediate tubular sheath body comprising a second material, the intermediate tubular sheath body extending from a proximal end to a distal end, the distal end of the intermediate tubular sheath body connected to the proximal end of the main tubular sheath body; a hub comprising a third material connected to a proximal portion of the intermediate tubular sheath body and separated from the main tubular sheath body by the intermediate tubular sheath body; Including, the first material, the second material, and the third material are configured such that a theoretical interfacial bond strength between the first material and the second material and a theoretical interfacial bond strength between the third material and the second material both exceed a theoretical interfacial bond strength between the first material and the third material.

2. 10. The device of claim 1, wherein the intermediate tubular sheath body has a first inner diameter at the distal end and a second inner diameter axially spaced proximal to the distal end, the second inner diameter being larger than the first inner diameter.

3. The device of claim 2 , wherein the second inner diameter is between 5 mm and 6 mm.

4. The device of any one of claims 1 to 3, wherein the first material comprises polyether block amide (PEBA).

5. The device of claim 1 , wherein the second material comprises a thermoplastic styrene butadiene copolymer.

6. The device of claim 1 , wherein the third material comprises acrylonitrile butadiene styrene.

7. The device of claim 1 , wherein the main tubular sheath body comprises multiple layers.

8. The device of claim 7 , wherein the plurality of layers includes a frame layer and a jacket.

9. The device of claim 8 , wherein the frame layer comprises nitinol and the outer jacket comprises polyether block amide (PEBA).

10. The device of claim 1 , further comprising a side port extending from the hub.

11. 10. The device of claim 1, further comprising a rotatable portion rotatable relative to the hub, the main tubular sheath body, and the intermediate tubular sheath body, the rotatable portion connected to a distal portion of the hub.

12. The device of claim 11 , wherein the rotatable portion is rotatable by at least 180 degrees.

13. The device of claim 12 , wherein the rotatable portion is rotatable by at least 360 degrees.

14. The device of claim 11 , wherein the rotatable portion is configured such that a side port extending from the hub lies against a patient.

15. The device of claim 11 , wherein the rotatable portion comprises a butterfly, a suture pad, or a combination thereof.

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