Vascular Access Systems

Abstract

A vascular access system (300, 500) including a sheath (350), a slit sleeve (110), and a sealing portion of the slit sleeve (110). The slit sleeve (110) includes a tubular sleeve body (111) having a longitudinal slit (112) along a length of the tubular sleeve body (111), the slit sleeve (110) adapted to receive a first portion of a medical device therein. The longitudinal slit (112) closes but does not seal after the first portion of the medical device is inserted into the longitudinal slit. The sealing portion of the slit sleeve (110) is configured to fill a gap and form a seal between an inner surface of the sheath (350) and a portion of the first portion of the medical device disposed within the sheath (350) when the sheath (350) is inserted into a blood vessel and the slit sleeve (110) is inserted into the sheath lumen. A vascular access device accessory (102, 202, 302, 502) and a method for inserting the same within a sheath (350) are also provided.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 285,300, filed December 2, 2021, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] background

[0002] Medical devices, such as intracardiac heart pump assemblies, can be introduced into a patient in a variety of ways. In general, a heart pump can be introduced into the heart to pump blood from the heart into blood vessels to assist the heart's function. Once placed in the heart, the heart pump assembly draws blood from the left ventricle of the heart and ejects it into the aorta, or draws blood from the inferior vena cava (IVC), bypassing the right atrium and right ventricle, and ejecting it into the pulmonary artery. The heart pump assembly can be introduced surgically or percutaneously through the vascular system during a cardiac procedure. In one common approach, the pump assembly is inserted through the femoral artery using a sheath by a catheter insertion procedure. Alternatively, the sheath can be inserted into other locations, such as the femoral vein, or into any pathway to deliver the pump to support either the left or right side of the heart.

[0003]

[0003] In general, an introducer sheath may be inserted into the femoral artery through an arteriotomy to create an insertion path for the pump assembly. A portion of the pump assembly is then advanced into the artery through the lumen of the introducer. Some medical introducers have an expandable sheath body that may expand radially to allow passage of a percutaneous device, such as a cardiac pump assembly, into the patient's vasculature. Such introducers are inserted with a resting inner diameter that is smaller than the outer diameter of the widest portion of the percutaneous device to be introduced. The introducer expands to allow passage of the percutaneous device through the sheath into the vasculature, and then contracts again to its resting inner diameter after the widest portion of the device has passed through the introducer.

[0004]

[0004] However, the resting inner diameter of the introducer is larger than the inner diameter of one or more of the narrower portions of the pump assembly (e.g., catheter) that typically pass through and / or remain within the introducer after the widest portion of the pump assembly has passed through the introducer. The space between the narrower portion of the pump assembly and the introducer can fill with blood. Clotting of blood within the introducer represents a risk to the patient, as forward movement of the device through the introducer can expel blood clots into the patient's vasculature, causing ischemia or stroke.

[0005]

[0005] An existing solution to prevent clot formation in the space between the introducer and the narrower portion of the pump assembly that resides within the introducer is to flush the introducer periodically or continuously. Adhering to a flush schedule and ensuring that there is not a shortage of continuous flush solution can be difficult for medical personnel, which can result in the formation of one or more clots. Also, these flushing techniques can be ineffective if the introducer is kinked. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] Additional structure is required to prevent blood from entering the space, and a means of positioning the additional structure in the narrower portion of the pump assembly after the pump has been introduced into the patient. [Means for solving the problem]

[0007] A quick overview

[0007] The present disclosure describes systems, devices, and methods for loading catheter-based devices with additional structure after such devices have been percutaneously inserted into a patient.

[0008]

[0008] In one aspect, the present disclosure describes a vascular access system including a first sheath, a slitted sleeve, and a sealing portion of the slitted sleeve. The first sheath has a first sheath lumen extending between a proximal end and a distal end of the first sheath. The first sheath is configured to allow passage of a first portion of a medical device. The medical device is configured to be inserted into a blood vessel. The first portion of the medical device has a first radial cross-section and the second portion of the medical device has a second radial cross-section that is larger than the first radial cross-section in at least one dimension. For brevity, the first radial cross-section and the second radial cross-section are referred to herein as a first width and a second width, respectively, or as a first diameter and a second diameter, respectively. The slitted sleeve includes a tubular sleeve body having a longitudinal slit along a length of the tubular sleeve body. The slitted sleeve is adapted to receive therein a first portion of a medical device that is loaded into the slitted sleeve through a longitudinal slit in the slitted sleeve. The tubular sleeve body has a first opening at its proximal end, a second opening at its distal end, and a continuous lumen from the first opening to the second opening. The longitudinal slit closes but does not seal after the first portion of the medical device is inserted into the longitudinal slit. The sealing portion of the slitted sleeve is configured, in operation, to fill a gap and form a seal between an inner surface of the first sheath and a portion of the first portion of the medical device disposed within the first sheath when the first sheath is inserted into the blood vessel and the slitted sleeve is inserted into the first sheath lumen and over a portion of the first portion of the medical device disposed within the first sheath such that blood from the vessel is substantially prevented from migrating past the seal.

[0009] In some embodiments, the sealing portion of the slit sleeve of the vascular access system is a slit sleeve tip at a distal open end of the tubular sleeve body. The slit sleeve tip has an inner surface that defines a slit sleeve tip lumen in fluid communication with the slit tubular sleeve body. In some embodiments of the vascular access system, an outer diameter of a proximal end of the slit sleeve tip is greater than an outer diameter of a distal end of the slit sleeve tip such that the slit sleeve tip tapers along its length from its proximal side to its distal side. In some embodiments of the vascular access system, a diameter of the inner surface of the slit sleeve tip at the proximal end is greater than a diameter of the inner surface of the slit sleeve tip at the distal end. In some embodiments of the vascular access system, a diameter of the inner surface of the slit sleeve tip at the proximal end is equal to a diameter of the inner surface of the slit sleeve tip at the distal end. In some embodiments, the slit sleeve tip of the vascular access system extends beyond the first sheath when the tubular sleeve body of the slit sleeve is inserted into the first sheath lumen.

[0010] In some embodiments, the tubular sleeve body of the vascular access system comprises a first material and the slit sleeve tip comprises a second material. In some embodiments, the first material of the vascular access system is substantially stiffer than the second material and the second material is substantially more elastic than the first material. In some embodiments, the first material of the vascular access system comprises at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, a polyether block amide (PEBA), a material having a modulus of elasticity of about 81-307 MPa, or a material having a yield strain of 20-30%. In some embodiments, the second material of the vascular access system comprises at least one of an ethylene vinyl acetate (EVA), a styrene-butadiene copolymer (SBC), a synthetic rubber, an elastomer, an elastic material, a material having a modulus of elasticity of about 1.6 ksi, or a material having a yield strain of more than 200%.

[0011]

[0011] In some embodiments, the first part of the medical device is a catheter coupled to a percutaneously insertable heart pump. In some embodiments, the slit sleeve of the vascular access system is configured to slide distally along the catheter and be advanced into a blood vessel while assembled to the catheter. In some embodiments, the slit sleeve of the vascular access system is configured to be inserted into the first sheath by axially moving the slit sleeve and the first sheath relative to one another along the longitudinal axes of the slit sleeve and the first sheath.

[0012] In some embodiments, both the slit sleeve and the first sheath of the vascular access system are configured to be slidably coupled to a first portion of a medical device (eg, a catheter).

[0013]

[0013] In some embodiments, the first sheath lumen of the vascular access system has a first inner diameter at rest and is configured to elastically expand from the first inner diameter to a second outer diameter during passage of a second portion of the medical device (i.e., a wider portion of the medical device) through the first portion. The first sheath lumen is configured to contract from the second inner diameter to the first inner diameter during passage of the first portion of the medical device (i.e., a portion of the medical device less wide than the second portion of the medical device) after the second portion of the medical device has passed therethrough, leaving a gap between an inner surface of the first sheath and an outer surface of the first portion of the medical device. In some embodiments, the first sheath of the vascular access system is expandable by blood pressure in the blood vessel to seal a space between an outer surface of the slit sleeve and an arteriotomy in the blood vessel.

[0014] In some embodiments of the vascular access system, the outer diameter of the first sheath is sized to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less.

[0015] In some embodiments of the vascular access system, the outer surface of the slit sleeve is coated with one of an anti-thrombogenic coating or a coating configured to reduce the likelihood of a thrombus forming between the first sheath and the first portion of the medical device (e.g., a catheter) when the first sheath and the first portion of the medical device are inserted into a blood vessel. In some embodiments of the vascular access system, the outer surface of the first sheath is coated with one of a hydrophilic coating, a hydrophobic coating, or a coating that reduces friction. In some embodiments of the vascular access system, the outer surface of the first sheath is coated with one of an anti-microbial coating or a coating configured to reduce the likelihood of an infection developing in the blood vessel when the first sheath is inserted into the blood vessel.

[0016]

[0016] In some embodiments, the vascular access system further includes a slit sleeve hub, the slit sleeve being received within the lumen of the first sheath hub.

[0017]

[0017] In some embodiments, the slit sleeve hub of the vascular access system comprises at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, polyether ether ketone (PEEK), or a polyether block amide (PEBA).

[0018] In some embodiments, the slotted sleeve hub and the first sheath hub of the vascular access system are configured to couple to one another by at least one of a threaded connection, a press-fit connection, or a clip-lock connection. In some embodiments, the first sheath hub of the vascular access system includes a feature configured for suturing to a patient. In some embodiments, the feature of the vascular access system configured for suturing to a patient includes a pair of suture wings.

[0019] In some embodiments, the slotted sleeve hub includes a hub slit, the hub slit being substantially aligned with a longitudinal slit in the slotted sleeve. In some embodiments, the slotted sleeve tip includes a tip slit, the tip slit being substantially aligned with a longitudinal slit in the slotted sleeve.

[0020]

[0020] In another aspect, the present disclosure describes a vascular access device accessory including a slitted sleeve, a closure, and a slitted sleeve hub, where the slitted sleeve is received within a lumen of the slitted sleeve hub. The slitted sleeve includes a tubular sleeve body extending from the slitted sleeve hub, and the slitted sleeve is adapted to receive a first portion of a medical device (e.g., a catheter) that is loaded into the slitted sleeve through a longitudinal slit in the slitted sleeve. The tubular sleeve body of the slitted sleeve defines a lumen as a first opening at its proximal end and a second opening at its distal end. The proximal end of the slitted sleeve is received by the lumen of the slitted sleeve hub. The longitudinal slit is closable, and the lumen of the slitted sleeve hub has a longitudinal opening through which the first portion of the medical device can be inserted. The closure is adapted to slide along the slitted sleeve and the first portion of the medical device, and includes an outer channel and an inner channel. The outer channel slidably engages the slotted sleeve and the inner channel slidably engages a first portion of the medical device. The outer channel has openings at a first end and a second end for receiving the slotted sleeve. The inner channel has an opening for slidably receiving the first portion of the medical device. The slotted sleeve hub includes a receiver for receiving and securing a closure therein.

[0021]

[0021] In some embodiments, the vascular access device accessory further includes a closure that does not have completely separate inner and outer channels. There is a partition between the portion of the closure that receives the slit sleeve and the portion of the closure through which the catheter passes. This partition can have many forms, and in one form is in the form of a radial wall that extends partially through the inner portion of the closure but does not close itself, defining separate channels for the sleeve and catheter.

[0022]

[0022] A method of inserting a vascular access device accessory into a sheath is contemplated. According to the method, a first sheath is inserted into a blood vessel through which a medical device is passed. The first sheath has a first sheath lumen extending between a proximal end and a distal end of the first sheath. The medical device has a first portion having a first radial cross-section and a second portion having a second radial cross-section that is larger than the first radial cross-section. The cross-section of the first sheath is larger than the first radial cross-section.

[0023]

[0023] According to the method, a second portion of the medical device having a second cross-section is advanced at least partially through the first sheath. A portion of the first portion of the medical device is then inserted into the vascular access device accessory. The vascular access device accessory has a slitted sleeve having a tubular sleeve body with a longitudinal slit along the length of the tubular sleeve body, a first opening at a proximal end of the tubular sleeve body, a second opening at a distal end of the tubular sleeve body, and a continuous lumen from the first opening to the second opening. The vascular access device accessory also has a slitted sleeve hub, the proximal end of the slitted sleeve being received within the lumen of the slitted sleeve hub, the slitted sleeve having a slitted sleeve hub and a closure extending from the slitted sleeve hub. The closure may have an outer channel and an inner channel, the outer channel slidably engaging the slitted sleeve. According to the method, a portion of a first portion of a medical device is inserted into a vascular device by i) placing the first portion of the medical device adjacent to a slitted sleeve, ii) sliding a closure along at least a portion of the length of the sleeve, thereby drawing the first portion of the medical device into the tubular sleeve body of the slitted sleeve through a longitudinal slit in the slitted sleeve, and iii) advancing a vascular access device accessory over the first portion of the medical device and into the proximal end of the first sheath lumen. In some embodiments, the method includes the steps of i) sliding the closure over the entire tubular sleeve body, thereby drawing the first portion of the medical device into the slitted sleeve along the entire length of the slitted sleeve, and ii) receiving the closure into the slitted sleeve hub to secure the closure. The method may further include advancing the slitted sleeve hub into the lumen of the first sheath hub.Advancing the slitted sleeve hub into the lumen of the first sheath hub may include coupling the slitted sleeve hub into the first sheath hub by at least one of a threaded connection, a press-fit connection, a clip lock connection, a locking pin, a clamp, a twist lock, a pop lock, or a snap fit.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The foregoing and other objects and advantages will become apparent from a consideration of the following detailed description taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout. [Brief description of the drawings]

[0025] [Figure 1a]

[0025] An exemplary embodiment of a vascular access device accessory of the present disclosure is shown. [Figure 1b]

[0026] 1(a) shows the vascular access device accessory with a closure according to an embodiment of the present disclosure. [Figure 1c]

[0027] FIG. 1(b) shows an enlarged view of the distal end of the vascular access device accessory of FIG. [Diagram 2]

[0028] 1 illustrates a vascular access device accessory partially coupled to a catheter via an occluder, according to an embodiment of the present disclosure. [Diagram 3]

[0029] 1 illustrates a vascular access system including a vascular access device accessory and an introducer according to an embodiment of the present disclosure. [Figure 4a]

[0030] 1 illustrates a vascular access system according to an embodiment of the present disclosure with a vascular access device accessory docked within an introducer. [Figure 4b]

[0031] 4(a) shows a cross-sectional view of the vascular access system of FIG. 4(a). [Diagram 5]

[0032] 1 illustrates another embodiment of a vascular access device accessory of the present disclosure coupled to a catheter. [Figure 6]

[0033] 6 illustrates a vascular access system with the vascular access device accessory embodiment of FIG. 5 docked within an introducer sheath assembly. [Figure 7]

[0034] 1 illustrates a closure device of the present disclosure according to one embodiment. [Figure 8]

[0035] 1 illustrates a closure device of the present disclosure according to a second embodiment. [Figure 9]

[0036] 1 illustrates a closure device of the present disclosure according to a third embodiment. [Figure 10]

[0037] 13A-13C illustrate steps in a method of connecting a vascular access device accessory to a catheter without an occlusion, according to an embodiment of the present disclosure. [Figure 11]

[0038] 1 illustrates an exemplary method of loading a vascular assembly onto a catheter with or without an occluder, according to an embodiment of the present disclosure. [Figure 12]

[0039] 13 illustrates an alternative exemplary method of the present disclosure for loading a vascular assembly onto a catheter using an occluder. [Figure 13]

[0039] An alternative exemplary method of the present disclosure for loading a vascular assembly onto a catheter using an occluder is shown. [Figure 14]

[0039] An alternative exemplary method of the present disclosure for loading a vascular assembly onto a catheter using an occluder is shown. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Detailed Description

[0040] The embodiments of the present disclosure will be described in detail with reference to the drawings, in which similar reference numbers 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 details. Therefore, the specific structure and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to use the present disclosure in various ways in virtually any appropriately detailed structure.

[0027]

[0041] As used herein, including in the claims, terms describing shape, such as circle, circular, or square, are meant to be within reasonable manufacturing tolerances. Terms describing relative position, such as coaxial or collinear, are meant to be within reasonable manufacturing tolerances. Similarly, terms or phrases describing dimensions, such as a constant outer diameter along the length of an object, are meant to be within reasonable manufacturing tolerances.

[0028]

[0042] As used herein, including in the claims, "tubular" does not necessarily mean having a circular cross-section. Tubular articles may, for example, have elliptical, polygonal, irregular, or other shaped cross-sections.

[0029]

[0043] FIG. 1(a) illustrates a vascular access device accessory 102 of the present disclosure configured to be coupled to a medical device. In some embodiments, the medical device is a percutaneously inserted intracardiac blood pump including a second portion that is a pump assembly and a first portion that is a catheter coupled to the pump assembly. The intracardiac blood pump is configured to be inserted into a blood vessel of a patient. In some embodiments, a width of one or more portions of the pump assembly is greater than a width of the catheter.

[0030]

[0044] The vascular access device accessory 102 may include a slit sleeve 110, a closure 120, and a slit sleeve hub 130. The slit sleeve 110 has a longitudinal slit 112 and a tubular body 111 extending from a proximal end 110a of the slit sleeve 110 to a distal end 110b of the slit sleeve 110. The slit sleeve 110 is constructed from a semi-rigid material that allows for some flexibility. Such flexibility allows the longitudinal slit 112 to be closable in some embodiments. For example, the slit sleeve 110 may be constructed from a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, a polyether block amide (PEBA), a material with an elastic modulus of about 81-307 MPa, or a material with a yield strain of 20-30%. The exterior surface of the slit sleeve 110 may be coated. For example, the slit sleeve 110 may be coated with an anti-thrombogenic coating or a coating configured to reduce the likelihood of a thrombus forming between the first sheath and the catheter when the first sheath and the catheter are inserted into a blood vessel.

[0031]

[0045] The vascular access device accessory may further include a sealing portion of the slit sleeve configured to fill a gap and form a seal between an inner surface of the first sheath and a portion of the first portion of the medical device disposed within the first sheath when the first sheath is inserted into the blood vessel and the slit sleeve is inserted into the first sheath lumen and over a portion of the first portion of the medical device disposed within the first sheath, such that blood from the blood vessel is substantially prevented from migrating past the seal in operation. In some embodiments, the sealing portion of the slit sleeve is the slit sleeve tip 118. In some embodiments, the slit sleeve tip 118 is disposed at the distal end 110b of the slit sleeve 110. In other embodiments, the slit sleeve tip 118 is disposed at another location on the slit sleeve 110. In still other embodiments, the sealing portion of the slit sleeve is a separate component attached to the distal end 110b of the slit sleeve 110 or another location on the slit sleeve 110. The slit sleeve tip has an inner surface defining a slit sleeve tip lumen 119 in fluid communication with the tubular body 111 of the slit sleeve 110. The proximal end 110a of the slit sleeve 110 is received within a lumen 132 of the slit sleeve hub 130. The lumen 132 of the slit sleeve hub 130 includes a longitudinal opening 136 that is aligned with the longitudinal slit 112 of the slit sleeve 110. The longitudinal opening 136 of the lumen 132 is aligned with the longitudinal slit 112 of the slit sleeve 110 such that a portion of a medical device may be received therein. FIG. 1(b) illustrates a closure or zipper 120 of the present disclosure disposed on the slit sleeve 110 of the vascular access device accessory 102 of FIG. 1(a). Although FIG. 1(b) shows the closure portion 120 positioned at the distal end of the slit sleeve 110 of FIG. 1(a), the closure portion 120 may be positioned anywhere along the tubular body 111 of the slit sleeve 110.

[0032]

[0046] FIG. 1(c) shows a close-up view of the distal end 110b of the slit sleeve 110 of the vascular access device accessory 102 of FIG. 1(b). Specifically, FIG. 1(c) shows the proximal end 118a of the slit sleeve tip 118 and the distal end 118b of the slit sleeve tip 118. The slit sleeve tip 118 further includes a longitudinal opening 117 that is aligned with the longitudinal slit 112 and the longitudinal opening 136 of the lumen 132. In certain embodiments, the proximal end 118a and the distal end 118b of the slit sleeve tip can have different diameters. For example, the diameter of the proximal end 118a can be larger than the diameter of the distal end 118b such that the slit sleeve tip 118 is tapered. Alternatively, the diameter of the proximal end 118a can be the same as the diameter of the distal end 118b. The slit sleeve tip 118 may be constructed from the same or similar material as the slit sleeve 110. Alternatively, the slit sleeve tip 118 may be constructed from a second material, which is substantially more elastic than the first material of the slit sleeve 110. For example, the second material may be ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), synthetic rubber, an elastomer, a resilient material, a material with a modulus of elasticity of about 1.6 ksi, or a material with a yield strain of greater than 200%.

[0033]

[0047] 2 illustrates an exemplary vascular access device accessory 202 of the present disclosure including a first portion of a medical device, such as a catheter 240, in a first stage of connection. The catheter 240 is connected to the vascular access device accessory by a closure 220 at the distal end 210b of the slit sleeve 210 and a slit sleeve tip 218. The proximal end 210a of the slit sleeve 210, along with the slit sleeve hub 230, remain disconnected from the catheter 240.

[0034]

[0048] 3, 4(a) and 4(b) show an embodiment of a vascular access system 300 of the present disclosure including a vascular access device accessory 302, an introducer 301 and a first portion of a medical device, such as a catheter 340. The introducer 301 includes a sheath 350 defined by a distal end 350b, a proximal end 350a and a sheath lumen extending through the sheath 350 between the proximal end 350a and the distal end 350b. A sheath hub 360 is attached to the sheath 350 at the proximal end 350a of the sheath 350. The sheath 350 may be coated with a hydrophilic coating, a hydrophobic coating or a coating that reduces friction. The sheath 350 may also be coated with an antimicrobial coating or a coating that otherwise reduces the likelihood of an infection developing within a blood vessel when the sheath 350 is inserted into the blood vessel. The sheath 350 is configured to allow passage of a medical device within the sheath 350. Both the slit sleeve 310 of the vascular access device accessory 302 and the sheath of the introducer 301 are configured to slidably engage a medical device, including a catheter 340.

[0035]

[0049] In one embodiment, the sheath of the introducer 301 has a constant, predetermined diameter. The diameter is constant over the entire length of the sheath 350. If the sheath 350 of the introducer 301 is not radially expandable, the diameter must be large enough to accommodate the widest or largest diameter portion of the medical device (e.g., the pump assembly) even if other portions of the medical device (e.g., the catheter) have a significantly smaller width / diameter.

[0036]

[0050] In an alternative embodiment, the sheath 350 of the introducer 301 has a variable diameter. The diameter is variable over the entire length of the sheath 350. The sheath lumen of the sheath 350 can have a first inner diameter at rest. The sheath lumen of the sheath 350 can be configured to elastically expand to the second inner diameter when the second portion of the medical device passes through the sheath lumen. The sheath lumen of the sheath 350 can also be configured to contract from the second inner diameter to the first inner diameter when the first portion of the medical device passes through the sheath lumen. The first inner diameter is dimensioned to be larger than the diameter of the first portion of the medical device such that a gap is created between the inner surface of the sheath 350 and the outer surface of the first portion of the medical device. For example, the second portion of the medical device can be a pump assembly of an intracardiac blood pump and the first portion of the medical device can be a catheter of the intracardiac blood pump. In another example, the second portion of the medical device may be the pump head and pump body of an intracardiac blood pump, and the first portion of the medical device may be the catheter of the intracardiac blood pump.

[0037]

[0051] In one embodiment, the outer diameter of the sheath 350 is about 20 Fr (6.67 mm) or less, which allows the sheath 350 to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less.

[0038]

[0052] Fluid is introduced into the assembly through a side arm channel 370 (FIG. 3), and the flow of fluid into the device may be controlled by a stopcock 371. A hemostatic valve (not shown) may also be included in the hub 360, configured to prevent blood from leaking outside the patient's body during insertion and / or removal of a medical device (e.g., an intracardiac blood pump) or other component. Additionally, in some embodiments, the hub 360 may include a foam insert (not shown) placed proximal to the hemostatic valve, which may be soaked in a lubricant, such as silicone, so that components are lubricated as they are inserted into the sheath body 350 through the foam. Suturing wings 362 (e.g., butterfly pads) are disposed on the sheath hub 360. In one embodiment, the suture wings 362 include a pair of suture wings, each suture wing 362 disposed on either side of the axis 314. The suture wings 362 are configured to be used to suture the vascular access system 300 to a patient.

[0039]

[0053] 3 also shows a vascular access device accessory 302 and introducer 301 of the present disclosure coupled to a catheter 340. The catheter 340 is disposed within the slit sleeve 310 and lumen 332 of the slit sleeve hub 330 of the vascular access device accessory 302. In some embodiments of the present disclosure, the slit sleeve 310 is configured to be inserted into the sheath lumen of the sheath 350. The slit sleeve 310 can be moved axially along the axis 314 and the catheter 340 such that the slit sleeve 310 passes through the sheath hub 360 and into the sheath lumen of the sheath 350. Alternatively, the sheath 350 can be moved axially along the axis 314 and the catheter 340 until the slit sleeve 310 is inserted into the sheath lumen of the sheath 350. Alternatively, the slit sleeve 310 and the sheath 350 can be moved axially relative to one another along the axis 314 and the catheter 340. The slotted sleeve hub 330 can be configured to dock inside the sheath hub 360 when the slotted sleeve 310 is inserted into the sheath 350 .

[0040]

[0054] In some embodiments, the slotted sleeve hub 330 can be configured to lock into the sheath hub 360, as shown in Figures 4(a) and 4(b). For example, the slotted sleeve hub 330 can be locked into the sheath hub 360 using a threaded connection, a press-fit connection, a clip lock connection, a locking pin, a clamp, a twist lock, a pop lock, a snap fit, or the like.

[0041]

[0055] 4(a) shows the vascular access device accessory 300 when the vascular access system 302 and introducer 301 are docked while connected to a catheter 340. When docked, the slit sleeve 310 is received within the lumen of the sheath 350 and the slit sleeve hub 330 is received within the sheath hub 360. In some embodiments, the slit sleeve tip 318 can extend beyond the sheath 350 when the slit sleeve 310 is inserted into the sheath 350.

[0042]

[0056] FIG. 4(b) shows a cross-sectional view of the vascular access device accessory 300 when the vascular access system 302 and introducer 301 are docked while connected to the catheter 340. The slit sleeve 310 fills the gap between the outer diameter of the catheter 340 and the inner diameter of the sheath 350 when at rest, substantially preventing blood from entering the gap. In some embodiments, when the slit sleeve tip 318 extends beyond the sheath 350, the slit sleeve tip 318 can be advanced into the patient's blood vessel and act as a seal such that blood from the vessel is substantially prevented from migrating past the seal. Additionally, when the slit sleeve tip 318 is tapered, the slit sleeve tip 318 can be advanced such that the portion of the slit sleeve tip 318 having a diameter most similar to a portion of the diameter of the patient's incision is positioned within the incision. A tapered slit sleeve tip 318 is preferred as it acts as a more effective seal for incisions of various sizes.

[0043]

[0057] 5 and 6 show an alternative embodiment of a vascular access system 500 of the present disclosure. In FIG. 5, a vascular access device accessory 502 is coupled to a portion of a medical device, such as a catheter 540. The vascular access device accessory 502 includes a slit sleeve 510 and a slit sleeve hub 530. A catheter 540 is disposed within a lumen 532 of the slit sleeve 510 and slit sleeve hub 530 of the vascular access device accessory 502. FIG. 6 shows the vascular access system 500 with the hub 530 / sleeve 510 assembly of FIG. 5 inserted into the hub 560 / sheath 550 assembly. FIG. 6 shows the vascular access system 500 with the vascular access device accessory coupled to the introducer 550 sheath and catheter 540. Fluids can be introduced into the assembly through a side arm channel 570. In some embodiments where the vascular access system 500 is not sealed with a closure, for example when a side arm is used to aid in distal perfusion, fluid (eg, blood) may also escape.

[0044]

[0058] The closures described herein may have any suitable shape or geometry. For ease of illustration, the closures are shown as generally annular in shape, but this is not a requirement. The closures may be annular, elliptical, polygonal, irregular, or have another cross-sectional shape. The specific shape may be selected by one of ordinary skill in the art considering the form and function of the closures described herein. FIG. 7 illustrates an embodiment of a closure 720 of the present disclosure. The closure 720 includes an outer channel 722 and an inner channel 724. The inner channel 724 is defined by an inner perimeter of an inner wall 727. In one embodiment, the closure 720 is circular and the outer channel 722 and the inner channel 724 are defined by perimeters. The outer channel 722 is defined by an outer peripheral surface of the inner wall 727, an inner peripheral surface of the outer wall 725, a first radial surface 722a, and a second radial surface 722b, both of which extend from the outer peripheral surface of the inner wall 727 to the inner peripheral surface of the outer wall 725. The closure 720 includes a radial opening 729 extending from the inner channel 724 through the outer peripheral surface of the outer wall 725. The radial opening 729 is defined by the inner peripheral surface of the inner wall 727, the outer peripheral surface of the outer wall 725, and a radial wall. The radial wall extends from the inner peripheral surface of the inner wall 727 to the outer peripheral surface of the outer wall 725. The radial wall 726 has first and second edges on the inner peripheral surface of the inner wall 727 and the outer peripheral surface of the outer wall 725, respectively. For example, radial wall 726 has a first rounded edge 726a at an outer circumferential surface of wall 725 and a second rounded edge 726b at an inner circumferential surface of wall 727. In some embodiments, the circumferential surface is circular.

[0045]

[0059] The closure 720 is configured to slidably engage the tubular body of the slit sleeve and the medical device catheter. The closure 720 has openings on both sides such that the slit sleeve can be received within the outer channel 722. Following insertion of the slit sleeve into the outer channel 722, the catheter can be received within the inner channel 724 through the opening 729 and rest on the inner circumferential surface of the inner wall 727. The closure 720 is further configured to be advanced along the length over the tubular body of the slit sleeve and the catheter such that the slit sleeve is placed on the catheter, for example, as seen in FIG. 3. Additionally, the closure 720 is configured to be received and docked within the slit sleeve hub after the closure 720 is advanced along the length of the tubular sleeve body of the slit sleeve.

[0046]

[0060] 8 illustrates a second embodiment of a closure 820 of the present disclosure. The closure 820 includes an outer channel 822 and an inner channel 824. The inner channel 824 is defined by the inner circumferential surfaces of inner walls 827a, 827b. The outer channel 822 is defined by the inner surfaces of the inner walls 827a, 827b, the inner circumferential surface of the outer wall 825, and a first radial surface 822a and a second radial surface 822b, both of which extend from the outer circumferential surface of the inner wall 827 to the inner circumferential surface of the outer wall 825. The first inner wall 827a and the second inner wall 827b may be the same size and shape. Each inner wall 827a, 827b may extend from a radial wall, such as radial wall 826, to a third radial surface 822c and a fourth radial surface 822d, respectively. The third radial surface 822c and the fourth radial surface 822d extend from the outer circumferential surface of the inner walls 827a, 827b to the inner circumferential surface of the inner walls 827a, 827b. The closure 820 includes a radial opening 829 that extends from the inner channel 824 through the outer circumferential surface of the outer wall 825. The radial opening 829 is defined by the inner circumferential surface of the inner walls 827a, 827b, the outer circumferential surface of the outer wall 825, the radial wall, and a flat edge surface. The radial wall extends from the inner circumferential surface of the inner walls 827a, 827b to the outer circumferential surface of the inner walls 827a, 827b. The radial wall has a first edge and a second edge. For example, radial wall 826 has a first flat edge 826a that extends from the outer periphery of outer wall 825 to the outer periphery of inner wall 827, and a second edge 826b at the inner periphery of wall 827. In some embodiments, the periphery is circular.

[0047]

[0061] 9 illustrates a third embodiment of a closure 920 of the present disclosure. The closure 920 includes an outer channel 922 and an inner channel 924. The inner channel 924 is defined by an inner circumferential surface of an inner wall 927. The outer channel 922 is defined by outer circumferential surfaces of inner walls 927a, 927b, an inner circumferential surface of an outer wall 925, and a first radial surface 922a and a second radial surface 922b, both of which extend from the outer circumferential surface of the inner wall 927 to the inner circumferential surface of the outer wall 925. The first inner wall 927a and the second inner wall 927b may be the same size and shape. Each portion of the inner walls 927a, 927b may extend from a radial wall, such as the radial wall 926, to a third radial surface 922c and a fourth radial surface 922d, respectively. The third radial surface 922c and the fourth radial surface 922d extend from the outer circumferential surface of the inner walls 927a, 927b to the inner circumferential surface of the inner walls 927a, 927b. The closure portion 920 includes a radial opening 929 that extends from the inner channel 924 through the outer circumferential surface of the outer wall 925. The radial opening 929 is defined by the inner circumferential surface of the inner wall 927, the outer circumferential surface of the outer wall 925, and the radial wall. The radial wall has a first edge and a second edge on the inner circumferential surface of the inner walls 927a, 927b and the outer circumferential surface of the wall 925, respectively. For example, radial wall 926 has a first rounded edge 926a at an outer circumferential surface of wall 925 and a second rounded edge 926b at an inner circumferential surface of wall 927. In some embodiments, the circumferential surface is circular.

[0048]

[0062] The operation of the closure of the present disclosure shown in Figures 8 and 9 is similar to that of the closure of Figure 7, but the closure of Figures 8 and 9 does not have a completely separate channel through which the sleeve slides and the catheter is drawn into the sleeve. For convenience, the operation of the closures in Figures 8 and 9 will be described together using the corresponding reference numbers of Figures 8 and 9, respectively. The closures 820, 920 have openings on both sides through which the slit sleeve can be received into the outer channels 822, 922. Alternatively, the slit sleeve can be received into the outer channels 822, 922 through the openings 829, 929 and then manipulated so that the slit sleeve extends into the channels 822, 922. The catheter of the medical device can be received into the inner channels 824, 924 through the openings 829, 929 and rest on the inner surface of the slit sleeve in addition to the inner circumferential surface of the inner walls 827a, 927a, 827b, 927b. When positioned within the closure 820, 920, the slitted sleeve is slidably engaged with the closure 820, 920 and a catheter received within the closure 820, 920. The closure 820, 920 is further configured to be advanced along the length of the tubular body of the slitted sleeve and the catheter such that the slitted sleeve receives the catheter, for example, as seen in Figure 3. Additionally, the closure 820, 920 is configured to be received and docked within the slitted sleeve hub after the closure 820, 920 is advanced along the length of the tubular sleeve body of the slitted sleeve.

[0049]

[0063] 10 illustrates steps 1000 and 1010 of the disclosed method of coupling a vascular access device accessory 502 to a first portion of a medical device, such as a catheter 540. In step 1000, the slit sleeve hub 530 and a portion of the slit sleeve 510 are placed onto the catheter 540. Between steps 1000 and 1001, the user presses the slit sleeve 510 onto the catheter 540. As a result, in step 1010, the entire slit sleeve 510 and slit sleeve hub 530 are coupled to the catheter 540.

[0050]

[0064] FIG. 11 illustrates an exemplary method 1100 of the present disclosure for inserting a first portion of a medical device, such as a catheter portion of a medical device, into a vascular access assembly. Step 1110 illustrates placing the catheter adjacent to a longitudinal slit of a slotted sleeve of the assembly. Step 1120 illustrates pushing at least a portion of the catheter into the slotted sleeve through the longitudinal slit of the vascular access device accessory. If a closure is available, then in step 1130, a closure is slid over the entire tubular body of the slotted sleeve to pull the catheter into the slotted sleeve. Following step 1130, in step 1140, a closure is received into the slotted sleeve hub to secure the annular sleeve in place. Alternatively, as in step 1130', if a closure is not available, then an additional portion of the catheter is manually pushed into the longitudinal slit such that the additional portion of the catheter is disposed within the entire length of the tubular body of the slotted sleeve.

[0051]

[0065] 12 illustrates an alternative insertion method 1200 of the present disclosure. In step 1210, a catheter is placed adjacent to the longitudinal slit of a slitted sleeve of a vascular access device accessory. Then, in step 1220, at least a portion of the catheter is pushed into the slitted sleeve through the longitudinal slit with a closure. In step 1230, the closure is slid over the entire tubular body of the slitted sleeve, thereby drawing the catheter into the slitted sleeve along its entire length. In step 1240, the closure is received within the slitted sleeve hub to secure the catheter in place.

[0052]

[0066] 13 illustrates another alternative insertion method 1300 of the present disclosure. In step 1310, a catheter is placed adjacent to a longitudinal slit of a slitted sleeve of a vascular access device accessory. Then, in step 1320, at least a portion of the catheter is pushed through the longitudinal slit into the slitted sleeve with a closure. In step 1330, the tubular body of the slitted sleeve is slid through the closure to retract the catheter into the full length of the slitted sleeve. In step 1340, the closure is received into the slitted sleeve hub to secure the closure within the slitted sleeve hub.

[0053]

[0067] 14 depicts a further alternative insertion method 1400 of the present disclosure. In step 1410, a catheter is placed adjacent to a longitudinal slit of a slitted sleeve of a vascular access device accessory. Then, in step 1420, at least a portion of the catheter is pushed through the longitudinal slit into the slitted sleeve with an occluder. In step 1430, the catheter is slid over the entire tubular body of the slitted sleeve through the occluder. In step 1440, a occluder is received within the slitted sleeve hub to secure the occluder within the slitted sleeve hub.

[0054]

[0068] In one aspect, a vascular access system is provided comprising: i) a first sheath having a first sheath lumen extending between a proximal end and a distal end of the first sheath, the first sheath configured to permit passage of a first portion of a medical device, the medical device configured to be inserted into a blood vessel, the first portion of the medical device having a first radial cross-section and a second portion of the medical device having a second radial cross-section that is greater than the first radial cross-section; and ii) a slitted sleeve, the slitted sleeve including a tubular sleeve body having a longitudinal slit along a length of the tubular sleeve body, the slitted sleeve adapted to receive therein the first portion of the medical device that is loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve, the tubular sleeve being configured to receive therein the first portion of the medical device. the slitted sleeve has a longitudinal sleeve body having a first opening at a proximal end, a second opening at a distal end, and a continuous lumen from the first opening to the second opening, the longitudinal slit closing but not sealing after a first portion of a medical device is inserted into the longitudinal slit; and iii) a sealing portion of the slitted sleeve configured to, in operation, fill the gap and form a seal between an inner surface of the first sheath and a portion of the first portion of the medical device disposed within the first sheath when the first sheath is inserted into the blood vessel and the slitted sleeve is inserted into the first sheath lumen and over the portion of the first portion of the medical device disposed within the first sheath, such that blood from the blood vessel is substantially prevented from migrating across the seal.

[0055]

[0069] In one aspect, the sealed portion of the slit sleeve is a slit sleeve tip at a distal open end of the tubular sleeve body, the slit sleeve tip having an inner surface defining a slit sleeve tip lumen in fluid communication with the slit tubular sleeve body.

[0056]

[0070] In any of the above aspects, the outer diameter of the proximal end of the slit sleeve tip is greater than the outer diameter of the distal end of the slit sleeve tip such that the slit sleeve tip tapers along its length from its proximal side to its distal side.

[0057]

[0071] In any of the above aspects, the diameter of the inner surface of the slitted sleeve tip at the proximal end is greater than the diameter of the inner surface of the slitted sleeve tip at the distal end.

[0058]

[0072] In any of the above aspects, the diameter of the inner surface of the slitted sleeve tip at the proximal end is equal to the diameter of the inner surface of the slitted sleeve tip at the distal end.

[0059]

[0073] In any of the above aspects, the slit sleeve tip extends beyond the first sheath when the tubular sleeve body of the slit sleeve is inserted into the first sheath lumen.

[0060]

[0074] In any of the above aspects, the tubular sleeve body comprises a first material and the slit sleeve tip comprises a second material.

[0061]

[0075] In any of the above embodiments, the first material is substantially more rigid than the second material, and the second material is substantially more elastic than the first material.

[0062]

[0076] In any of the above aspects, the first material includes at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, a polyether block amide (PEBA), a material having an elastic modulus of about 81-307 MPa, or a material having a yield strain of 20-30%.

[0063]

[0077] In any of the above embodiments, the second material includes at least one of ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), a synthetic rubber, an elastomer, a elastomeric material, a material with a modulus of elasticity of about 1.6 ksi, or a material with a yield strain of greater than 200%.

[0064]

[0078] In any of the above embodiments, the first portion of the medical device is a catheter connected to a percutaneous heart pump system.

[0065]

[0079] In any of the above aspects, the slitted sleeve is configured to slide distally along the catheter and be advanced into the blood vessel while assembled to the catheter.

[0066]

[0080] In any of the above aspects, the slit sleeve is configured to be inserted into the first sheath by axially moving the slit sleeve and the first sheath relative to each other along the longitudinal axes of the slit sleeve and the first sheath.

[0067]

[0081] In any of the above aspects, the outer surface of the slitted sleeve is coated with at least one of an anti-thrombogenic coating or a coating configured to reduce the likelihood of a thrombus forming between the first sheath and the first portion of the medical device when the first sheath and the first portion of the medical device are inserted into a blood vessel.

[0068]

[0082] In any of the above aspects, the exterior surface of the first sheath is coated with one of a hydrophilic coating, a hydrophobic coating, or a coating that reduces friction.

[0069]

[0083] In any of the above aspects, the outer surface of the first sheath is coated with one of an antimicrobial coating or a coating configured to reduce the likelihood of an infection developing within a blood vessel when the first sheath is inserted into the blood vessel.

[0070]

[0084] In any of the above aspects, the vascular access system further includes a slit sleeve hub, the slit sleeve being received within the lumen of the first sheath hub.

[0071]

[0085] In any of the above aspects, the slotted sleeve hub comprises at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, polyetheretherketone (PEEK), or a polyether block amide (PEBA).

[0072]

[0086] In any of the above aspects, the slotted sleeve hub and the first sheath hub are configured to couple to one another by at least one of a threaded connection, a press-fit connection, or a clip lock connection.

[0073]

[0087] In any of the above aspects, the slotted sleeve hub includes a hub slit, the hub slit being substantially aligned with the longitudinal slit in the slotted sleeve.

[0074]

[0088] In any of the above aspects, the slotted sleeve tip includes a tip slit, the tip slit being substantially aligned with the longitudinal slit in the slotted sleeve.

[0075]

[0089] In another aspect, a vascular access device accessory is described that includes: i) a slitted sleeve; ii) a slitted sleeve hub, the slitted sleeve being received within a lumen of the slitted sleeve hub; and iii) a closure. The slitted sleeve includes a tubular sleeve body having a longitudinal slit along its length, the slitted sleeve extending from the slitted sleeve hub, the slitted sleeve adapted to receive therein a first portion of a medical device that is loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve, the tubular sleeve body having a first opening at its proximal end, a second opening at its distal end, and a continuous lumen from the first opening to the second opening, the proximal end of the slitted sleeve being received by the lumen of the slitted sleeve hub. The longitudinal slit closes but does not seal after the first portion of the medical device is inserted into the longitudinal slit. The closure is adapted to slide along the slotted sleeve and the first portion of the medical device and includes an outer channel and an inner channel, the outer channel slidably engaging the slotted sleeve and the inner channel slidably engaging the first portion of the medical device such that sliding the closure along the length of the slotted sleeve draws the first portion of the medical device into the slotted sleeve. The slotted sleeve hub includes a receiver for receiving and securing the closure therein.

[0076]

[0090] In another aspect, the outer channel is at least partially defined by the inside of the outer wall and the outside of the inner wall of the closure portion, the inner channel communicates with a radial opening in the closure portion through which a first portion of the medical device is retracted, and the inner channel is at least partially defined by the inside of the inner wall of the closure portion.

[0077]

[0091] In any of the above alternative aspects, the inner wall of the closure has two portions, each of which extends from a side of the radial opening, each portion extending between the first channel and the second channel, and the two portions not connected.

[0078]

[0092] In any of the other aspects above, the radial opening has a first surface extending from an outer surface of the outer wall to an inner surface of the inner wall, each inner wall having an inner surface forming an annular surface within the annular opening.

[0079]

[0093] In any of the other aspects above, a radial opening is formed in the outer wall and extends through the outer wall, and each of the two portions of the inner wall extends between the first channel and the second channel from opposite sides of the radial opening, and the two portions are not connected.

[0080]

[0094] In any of the alternative embodiments above, each inner wall has a first inner surface forming an annular surface within the annular opening and a second inner surface partially separating the first channel and the second channel.

[0081]

[0095] In any of the alternative embodiments above, the second inner surface of each of the two portions of the inner wall is curved.

[0082]

[0096] In any of the alternative aspects above, the vascular access device accessory further includes a sealing portion of the slitted sleeve configured to fill a gap and form a seal between an inner surface of the first sheath and a portion of the first portion of the medical device disposed within the first sheath when the first sheath is inserted into the blood vessel and the slitted sleeve is inserted into the first sheath lumen and over a portion of the first portion of the medical device disposed within the first sheath, such that, in operation, blood from the blood vessel is substantially prevented from migrating past the seal.

[0083]

[0097] In any of the above alternative aspects, the sealed portion of the slit sleeve is a slit sleeve tip at the distal open end of the tubular sleeve body, the slit sleeve tip having an inner surface defining a slit sleeve tip lumen in fluid communication with the slit tubular sleeve body.

[0084]

[0098] In yet another aspect, a method of inserting a vascular access device accessory into a first sheath is described, the method including: i) inserting the first sheath into a blood vessel through which a medical device is to be passed, the first sheath having a first sheath lumen extending between a proximal end and a distal end of the first sheath, the medical device having a first portion having a first radial cross-section and a second portion having a second radial cross-section that is larger than the first radial cross-section, the cross-section of the first sheath being larger than the first radial cross-section; ii) advancing the second portion of the medical device having the second cross-section at least partially through the first sheath; iii) inserting a portion of the first portion of the medical device into the vascular access device accessory; and iv) advancing the vascular access device accessory over the first portion of the medical device and into the proximal end of the first sheath lumen. The vascular access device accessory includes: a) a slitted sleeve including a tubular sleeve body having a longitudinal slit along a length of the tubular sleeve body, a first opening at a proximal end of the tubular sleeve body, a second opening at a distal end of the tubular sleeve body, and a continuous lumen from the first opening to the second opening; b) a slitted sleeve hub, wherein a proximal end of the slitted sleeve is received within the lumen of the slitted sleeve hub and the slitted sleeve extends from the slitted sleeve hub; and c) a closure including an outer channel and an inner channel, the outer channel extending from the slitted sleeve hub to the distal end of the tubular sleeve body. The side channel may include a closure that slidably engages the slotted sleeve, and a portion of the first portion of the medical device is inserted into the vascular device accessory by 1) placing the first portion of the medical device adjacent to the longitudinal slit of the slotted sleeve, 2) placing a portion of the first portion of the medical device within the inner channel of the closure, and 3) sliding the closure along at least a portion of the length of the slotted sleeve, thereby drawing the first portion of the medical device through the longitudinal slit in the slotted sleeve and into the annular sleeve body of the slotted sleeve.

[0085]

[0099] In yet another embodiment, inserting a portion of the first portion of the medical device into the vascular access device accessory further comprises receiving the closure within the slit sleeve hub to secure the closure.

[0086]

[0100] In any of the above further aspects, the method further includes advancing a slitted sleeve hub into the lumen of the first sheath hub.

[0087]

[0101] In any of the above further aspects, advancing the slitted sleeve hub into the lumen of the first sheath hub includes coupling the slitted sleeve hub into the first sheath hub by at least one of a threaded connection, a press-fit connection, a clip lock connection, a locking pin, a clamp, a twist lock, a pop lock, or a snap fit.

[0088]

[0102] From the foregoing and with reference to the various drawings, one skilled in the art will recognize that certain modifications may be made to the present disclosure without departing from the scope of the present disclosure. Although several embodiments of the present disclosure are shown in the drawings, the present disclosure is not intended to be limited to those embodiments, as it is intended that the disclosure be as broad as the art will permit, and that the specification be read in the same manner. Therefore, the above description should not be construed as limiting, but merely as exemplifications of certain embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. 1. A vascular access system comprising: a first sheath having a first sheath lumen extending between a proximal end and a distal end of the first sheath, the first sheath configured to allow passage of a first portion of a medical device, the medical device configured to be inserted into a blood vessel, the first portion of the medical device having a first radial cross-section and a second portion of the medical device having a second radial cross-section that is larger than the first radial cross-section; a slitted sleeve including a tubular sleeve body having a longitudinal slit along its length, the slitted sleeve adapted to receive therein the first portion of the medical device loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve, the tubular sleeve body having a first opening at a proximal end thereof, a second opening at a distal end thereof, and a continuous lumen from the first opening to the second opening, the longitudinal slit closing but not sealing after the first portion of the medical device is inserted into the longitudinal slit; a sealing portion of the slitted sleeve configured to fill a gap and form the seal between an inner surface of the first sheath and the portion of the first portion of the medical device disposed within the first sheath when the first sheath is inserted into the blood vessel and the slitted sleeve is inserted into the first sheath lumen and over the portion of the first portion of the medical device disposed within the first sheath, such that, in operation, blood from the blood vessel is substantially prevented from migrating past the seal; 1. A vascular access system comprising:

2. 2. The vascular access system of claim 1, wherein the sealing portion of the slitted sleeve is a slitted sleeve tip at the distal open end of the tubular sleeve body, the slitted sleeve tip having an inner surface defining a slitted sleeve tip lumen in fluid communication with the slitted tubular sleeve body.

3. 3. The vascular access system of claim 2, wherein an outer diameter of the proximal end of the slitted sleeve tip is greater than an outer diameter of the distal end of the slitted sleeve tip such that the slitted sleeve tip tapers along its proximal-to-distal length.

4. 4. The vascular access system of claim 2, wherein the diameter of the inner surface of the slitted sleeve tip at the proximal end is larger than the diameter of the inner surface of the slitted sleeve tip at the distal end.

5. The vascular access system of claim 2 , wherein the diameter of the inner surface of the slitted sleeve tip at the proximal end is equal to the diameter of the inner surface of the slitted sleeve tip at the distal end.

6. 3. The vascular access system of claim 2, wherein the slitted sleeve tip extends beyond the first sheath when the tubular sleeve body of the slitted sleeve is inserted into the first sheath lumen.

7. The vascular access system of claim 2 , wherein the tubular sleeve body comprises a first material and the slit sleeve tip comprises a second material.

8. The vascular access system of claim 7 , wherein the first material is substantially stiffer than the second material, and the second material is substantially more elastic than the first material.

9. 8. The vascular access system of claim 7, wherein the first material comprises at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, a polyether block amide (PEBA), a material having an elastic modulus of about 81-307 MPa, or a material having a yield strain of 20-30%.

10. 8. The vascular access system of claim 7, wherein the second material comprises at least one of ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), synthetic rubber, an elastomer, a resilient material, a material with a modulus of elasticity of about 1.6 ksi, or a material with a yield strain greater than 200%.

11. The vascular access system of claim 1 , wherein the first portion of the medical device is a catheter connected to a percutaneous heart pump.

12. The vascular access system of claim 11 , wherein the slitted sleeve is configured to slide distally along the catheter and be advanced into the blood vessel while assembled to the catheter.

13. 2. The vascular access system of claim 1, wherein the slitted sleeve is configured to be inserted into the first sheath by axially moving the slitted sleeve and the first sheath relative to one another along longitudinal axes of the slitted sleeve and the first sheath.

14. 2. The vascular access system of claim 1, wherein the outer surface of the slitted sleeve is coated with at least one of an anti-thrombogenic coating or a coating configured to reduce the likelihood of thrombus formation between the first sheath and the first portion of the medical device when the first sheath and the first portion of the medical device are inserted into the blood vessel.

15. The vascular access system of claim 1 , wherein the outer surface of the first sheath is coated with one of a hydrophilic coating, a hydrophobic coating, or a friction-reducing coating.

16. 10. The vascular access system of claim 1, wherein an outer surface of the first sheath is coated with one of an antimicrobial coating or a coating configured to reduce the likelihood of infection developing within the blood vessel when the first sheath is inserted within the blood vessel.

17. The vascular access system of claim 1 , further comprising a slitted sleeve hub, the slitted sleeve received within the lumen of the first sheath hub.

18. 18. The vascular access system of claim 17, wherein the slitted sleeve hub comprises at least one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, polyetheretherketone (PEEK), or a polyether block amide (PEBA).

19. 19. The vascular access system of claim 17 or 18, wherein the slit sleeve hub and the first sheath hub are configured to couple to one another by at least one of a threaded connection, a press-fit connection, or a clip-lock connection.

20. 18. The vascular access system of claim 17, wherein the slotted sleeve hub includes a hub slit, the hub slit being substantially aligned with the longitudinal slit in the slotted sleeve.

21. The vascular access system of claim 2 , wherein the slitted sleeve distal end includes a distal slit, the distal slit being substantially aligned with the longitudinal slit in the slitted sleeve.

22. 1. A vascular access device accessory, comprising: Slit sleeves and a slitted sleeve hub, the slitted sleeve being received within a lumen of the slitted sleeve hub; Closure and Including, the slitted sleeve includes a tubular sleeve body having a longitudinal slit along its length, the slitted sleeve extending from the slitted sleeve hub, the slitted sleeve adapted to receive a first portion of a medical device therein, the first portion being loaded into the slitted sleeve through the longitudinal slit in the slitted sleeve, the tubular sleeve body having a first opening at a proximal end thereof, a second opening at a distal end thereof, and a continuous lumen from the first opening to the second opening, the proximal end of the slitted sleeve being received by the lumen of the slitted sleeve hub; the longitudinal slit closes but does not seal after the first portion of the medical device is inserted into the longitudinal slit; the closure is adapted to slide along the slit sleeve and the first portion of the medical device; an outer channel and an inner channel, the outer channel slidably engaging the slitted sleeve and the inner channel slidably engaging the first portion of the medical device such that sliding the closure along the length of the slitted sleeve draws the first portion of the medical device into the slitted sleeve; the slotted sleeve hub includes a receiving portion for receiving and securing the closure portion therein; Vascular access device accessories.

23. the outer channel is at least partially defined by an inner side of an outer wall and an outer side of an inner wall of the closure; 23. The vascular access device accessory of claim 22, wherein the inner channel communicates with a radial opening in the closure through which the first portion of the medical device is retracted, the inner channel being defined at least in part by the inside of the inner wall of the closure.

24. 24. The vascular access device accessory of claim 22 or 23, wherein the inner wall of the closure has two portions, each of the two portions extending from a side of the radial opening, each portion extending between the first channel and the second channel, and the two portions not connected.

25. 25. The vascular access device accessory of claim 24, wherein the radial opening has a first surface extending from an outer surface of the outer wall to the inner surface of the inner wall, each inner wall having an inner surface forming an annular surface within the annular opening.

26. 25. The vascular access device accessory of claim 24, wherein the radial opening is formed in and extends through the outer wall, and wherein each of the two portions of the inner wall extends from opposite sides of the radial opening between the first channel and the second channel, and the two portions are not connected.

27. 27. The vascular access device accessory of claim 26, wherein each inner wall has a first inner surface forming an annular surface within the annular opening and a second inner surface partially separating the first channel and the second channel.

28. 28. The vascular access device accessory of claim 27, wherein the second inner surface of each of the two portions of the inner wall is curved.

29. 23. The vascular access device accessory of claim 22, further comprising a sealing portion of the slitted sleeve configured to bridge a gap and form the seal between an inner surface of the first sheath and the portion of the first portion of the medical device disposed within the first sheath when a first sheath is inserted into the blood vessel and the slitted sleeve is inserted into a first sheath lumen and over a portion of the first portion of the medical device disposed within the first sheath, such that, in operation, blood from the blood vessel is substantially prevented from migrating past the seal.

30. 30. The vascular access device accessory of claim 29, wherein the sealing portion of the slitted sleeve is a slitted sleeve tip at the distal open end of the tubular sleeve body, the slitted sleeve tip having an inner surface defining a slitted sleeve tip lumen in fluid communication with the slitted tubular sleeve body.

Images