Guide wire access sleeve

Abstract

To provide a system and the like for accessing a medical device.SOLUTION: Access sleeve (200) may be attached to a medical device having a first end disposed within a patient and a second end disposed outside of the patient. The access sleeve includes a tubular sleeve body (210) having a first open end (225) and a second open end (235), the first and second open ends defining a first lumen (215) extending along a longitudinal axis (205) of the sleeve body. An opening (260) in the sleeve body connects the first lumen to the outer surface of the sleeve body. The access sleeve may be selectively attached to a medical device (e.g., a catheter of a heart pump) and inserted into the access site when the medical device is disposed within the patient. The access sleeve can maintain vascular access to the access site (e.g., arteriotomy) of the patient and can be removed without disturbing the position of the medical device.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 525,779, "Guidewire Access Sleeve," filed June 28, 2017, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] background Medical devices, such as intravascular heart pump assemblies, can be introduced into a patient's body in a variety of ways. Generally, a heart pump can pump blood from the heart into blood vessels to provide hemodynamic support. When placed in the left heart, the heart pump assembly pumps blood from the left ventricle and ejects blood into the aorta. When placed in the right heart, the heart pump assembly pumps blood from the inferior vena cava, bypassing the right atrium and right ventricle and ejecting blood into the pulmonary artery.

[0003] Heart pump assemblies are 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 catheterization procedure with a sleeve, such as a peel-away introducer sleeve. The peel-away introducer sleeve 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 through the lumen of the introducer and into the artery. Once the pump assembly is inserted, the peel-away introducer sleeve is peeled away. A repositioning sleeve may then be advanced over the pump assembly and into the arteriotomy.

[0004] In the event that pump removal and / or replacement is necessary, the peel-away introducer sleeve maintains access to the arterial access site, allowing a guidewire or other device to be inserted through a valve located within the introducer hub. After the pump is inserted, the introducer sleeve is removed (e.g., peeled away) to make way for a replacement sleeve. The replacement sleeve does not include a valve or pathway for inserting a device into the vessel. Therefore, if pump removal or replacement becomes necessary, another access procedure (i.e., creating an arteriotomy and inserting another introducer sleeve) is required to continue the planned interventional procedure. For short-term procedures, performing another access procedure requires more steps and additional time, increasing the cost of the procedure. Summary of the Invention

[0005] Systems, devices, and methods for accessing a medical device are presented. An access sleeve provides a means for maintaining vascular access during use of a repositioning sleeve or removal of the medical device. The access sleeve can be attached to a catheter of an indwelling pump, and then inserted into the patient's vasculature by sliding along the catheter body, using the pump catheter body itself as a rail. The catheter can then be removed, leaving the access sleeve in place to maintain access to the target vessel. Alternatively, a guidewire can be introduced using the indwelling access sleeve before catheter removal to maintain access to the arterial site, followed by removal of the catheter and pump. In certain configurations, once the guidewire has been used, the access sleeve can also be removed.

[0006] The access sleeve thus provides an in-line means for attachment to a medical device without requiring end access of the medical device. Instead of end access, the access sleeve of the present invention is attached to the extravascular portion of a medical device when the medical device is within the patient's vasculature. The access sleeve is then positioned within the target vessel by sliding it into place using the catheter body of the medical device as a guide. Once in place, the access sleeve maintains access to the vessel; and the medical device may be removed or repositioned as needed. By not requiring end access of the medical device, the access sleeve of the present invention can be easily integrated into many surgical procedures requiring access to a site within a patient's body, thereby eliminating the need for an additional access step during an interventional procedure.

[0007] One embodiment of the present disclosure provides an access sleeve for attachment to a medical device. The access sleeve includes a tubular sleeve body extending along a longitudinal axis of the access sleeve, the sleeve body having first and second open ends. The access sleeve further includes a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body. The access sleeve also includes a side opening in the sleeve body connecting the first lumen to an outer surface of the sleeve body. The side opening of the access sleeve is configured to be selectively expanded to attach the access sleeve to a medical device.

[0008] In some embodiments, the sleeve body includes a second lumen extending along a longitudinal axis between the first and second open ends of the sleeve body, the second lumen being sized and shaped to allow passage of a guidewire. In other embodiments, the opening extends linearly between the first and second open ends of the sleeve body and parallel to the longitudinal axis of the first lumen of the sleeve body. In certain embodiments, the opening extends helically or spirally between the first and second open ends of the sleeve body. In some embodiments, the sleeve includes an inner surface fabricated with an irregular geometry to minimize contact between the sleeve body and a medical device. In other embodiments, the inner surface includes at least one recess extending between the first and second open ends of the tubular sleeve body.

[0009] In certain embodiments, the access sleeve further comprises a hub attached to the second open end of the tubular sleeve body. In other embodiments, the access sleeve further comprises a tip at the first open end of the tubular sleeve body; the tip has an inner surface defining a tip lumen extending between the proximal and distal ends of the tip, the tip lumen being in fluid communication with the first lumen of the sleeve body. In some embodiments, the outer diameter of the proximal end of the tip is greater than the outer diameter of the distal end of the tip, such that the tip tapers from proximal to distal along its length. In other embodiments, the diameter of the inner surface at the proximal end of the tip is greater than the diameter of the inner surface at the distal end of the tip.

[0010] In certain embodiments, the diameter of the inner surface at the proximal end of the tip is equal to the diameter of the inner surface at the distal end of the tip. In other embodiments, the sleeve body comprises a first material and the tip comprises a second material. In some embodiments, the first material is substantially stiffer than the second material and the second material is substantially more elastic than the first material. In other embodiments, 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 (e.g., PEBA), a material having a modulus of elasticity of about 81-307 MPa, and a material having a yield strain of 20-30%. In certain embodiments, 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 having a modulus of elasticity of about 1.6 ksi, and a material having a yield strain of greater than 200%. In other embodiments, the hub is any one of a high density polyethylene (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, polyetheretherketone (PEEK), and a polyether block amide (such as PEBA).

[0011] Another embodiment of the present disclosure provides an access system. The access system includes a medical device configured to be inserted into an arteriotomy in a patient, the medical device having a first end and a second end. The access system also includes an access sleeve. The access sleeve includes a tubular sleeve body extending along a longitudinal axis, the sleeve body having first and second open ends. The access sleeve also includes a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body. The access sleeve further includes a side opening in the sleeve body connecting the first lumen to an outer surface of the sleeve body, the side opening including a slit extending along the longitudinal direction of the sleeve body. The medical device is disposed within the first lumen, and the first lumen is configured to be selectively expanded to attach the access sleeve to the medical device such that the first lumen at least allows passage of the medical device therethrough.

[0012] In some embodiments, the access sleeve body has a substantially C-shaped cross-sectional shape. In certain embodiments, the medical device includes a catheter, onto which the access sleeve is attached. In some embodiments, the access sleeve is configured to slide distally along the catheter and be advanced into the arteriotomy while attached to the catheter. In other embodiments, the sleeve further comprises a second lumen for passing a guidewire, extending along the longitudinal axis between the first and second open ends of the sleeve body. In some embodiments, the sleeve comprises an inner surface having an irregular geometry to minimize contact between the sleeve body and the medical device. In certain embodiments, the inner surface comprises at least one recess extending between the first and second open ends of the tubular sleeve body. In some embodiments, the access system further comprises a hub attached to the second open end of the tubular sleeve body.

[0013] A further embodiment of the present disclosure provides a method of attaching an access sleeve to a medical device positioned within a vascular site of a patient, such that the medical device includes a first portion positioned within the vasculature and a second portion positioned outside the patient's body. The method includes attaching the access sleeve to the second portion of the medical device via a first lumen. The method also includes positioning the access sleeve within the vasculature by sliding the access sleeve along the medical device (which serves as a rail to guide the access sleeve) such that the access sleeve is adjacent to the first portion of the medical device when positioned within the vasculature. The method also includes a final step of removing the medical device.

[0014] In some embodiments, the access sleeve further comprises a second lumen with a stylet, and the method further comprises removing the stylet from the second lumen once the access sleeve is positioned within the vasculature. In other embodiments, the method further comprises removing the access sleeve while maintaining the position of the guidewire within the vasculature. In certain embodiments, the method also further comprises removing the medical device from the vascular site. In some embodiments, the method further comprises removing the access sleeve while maintaining the position of the guidewire within the vasculature, and removing the medical device from the vascular site. [The present invention 1001] 1. A vascular access sleeve comprising: a tubular sleeve body extending along a longitudinal axis of the access sleeve and having first and second open ends; a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body; and a side opening in the sleeve body connecting the first lumen to an exterior surface of the sleeve body; Equipped with An access sleeve, wherein the side opening of the access sleeve is configured to be selectively expanded for attachment of the access sleeve to a medical device. [The present invention 1002] An access sleeve of the present invention 1001, wherein the sleeve body has a second lumen extending along the longitudinal axis between the first and second open ends of the sleeve body, the second lumen being sized and shaped to allow a guidewire to pass therethrough. [The present invention 1003] 1001. The access sleeve of claim 10, wherein the opening extends linearly between the first and second open ends of the sleeve body and is parallel to the longitudinal axis of the first lumen of the sleeve body. [The present invention 1004] The access sleeve of the present invention 1001, wherein the opening extends in a helical, spiral manner between the first and second open ends of the sleeve body. [The present invention 1005] 1001. The access sleeve of the present invention, wherein said sleeve has an inner surface fabricated with an irregular geometric shape to minimize contact between said sleeve body and said medical device. [The present invention 1006] The access sleeve of the present invention 1005, wherein said inner surface comprises at least one recess 5 extending between said first and second open ends of said tubular sleeve body. [The present invention 1007] The access sleeve of the present invention 1001 further comprising a hub attached to the second open end of said tubular sleeve body. [The present invention 1008] The access sleeve of the present invention 1001 further comprises a tip portion at a first open end of the tubular sleeve body, the tip portion having an inner surface defining a tip portion lumen extending between the proximal and distal ends of the tip portion, the tip portion lumen being in fluid communication with the first lumen of the sleeve body. [The present invention 1009] The access sleeve of the present invention 1001, wherein the outer diameter of the proximal end of the tip is greater than the outer diameter of the distal end of the tip so that the tip tapers from the proximal side to the distal side along its longitudinal direction. [The present invention 1010] The access sleeve of the present invention 1001, wherein the diameter of the inner surface at the proximal end of the tip is larger than the diameter of the inner surface at the distal end of the tip. [The present invention 1011] The access sleeve of the present invention 1001, wherein the diameter of the inner surface at the proximal end of the tip is equal to the diameter of the inner surface at the distal end of the tip. [The present invention 1012] 1001. An access sleeve according to claim 1001, wherein the sleeve body comprises a first material and the tip portion comprises a second material. [The present invention 1013] The access sleeve of the present invention 1012, wherein the first material is substantially stiffer than the second material and the second material is substantially more elastic than the first material. [The present invention 1014] The access sleeve of the present invention 1012, 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 (such as PEBA), a material having an elastic modulus of approximately 81 to 307 MPa, and a material having a yield strain of 20 to 30%. [The present invention 1015] The access sleeve of the present invention 1012, wherein the second material comprises at least one of ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), synthetic rubber, elastomer, elastic material, material with a modulus of elasticity of about 1.6 ksi, and material with a yield strain of greater than 200%. [The present invention 1016] The access sleeve of the present invention 1001, wherein the hub is any one of high density polyethylene (HDPE) material, medium density polyethylene (MDPE) material, low density polyethylene (LDPE) material, polyether ether ketone (PEEK), and polyether block amide (such as PEBA). [The present invention 1017] 1. An access system comprising: a medical device configured to be inserted into an arteriotomy in a patient, the medical device having a first end and a second end; a tubular sleeve body extending along a longitudinal axis and having first and second open ends; a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body; and a side opening in the sleeve body connecting the first lumen to an outer surface of the sleeve body, the side opening including a slit extending along the length of the sleeve body; an access sleeve having Equipped with the access sleeve is configured to be selectively expanded to attach the access sleeve to the medical device such that the medical device is disposed within the first lumen and the first lumen at least permits passage of the medical device. Access system. [The present invention 1018] The access system of the present invention 1017, wherein the access sleeve body has a substantially C-shaped cross-sectional shape. [The present invention 1019] The access system of the present invention 1017, wherein the medical device includes a catheter and the access sleeve is attached onto the catheter. [The present invention 1020] The access system of claim 1018, wherein the access sleeve is configured to slide distally along the catheter and be advanced into the arteriotomy while attached to the catheter. [The present invention 1021] The access system of claim 1017, wherein the sleeve further comprises a second lumen extending along the longitudinal axis between the first and second open ends of the sleeve body for passing a guidewire. [The present invention 1022] 1017. The access system of claim 1017, wherein the sleeve has an inner surface having an irregular geometry to minimize contact between the sleeve body and the medical device. [The present invention 1023] 1022. The access system of claim 1022, wherein the inner surface comprises at least one recess extending between the first and second open ends of the tubular sleeve body. [The present invention 1024] The access system of claim 1017, further comprising a hub attached to the second open end of the tubular sleeve body. [The present invention 1025] 1. A method of attaching an access sleeve to a medical device positioned within a vascular site of a patient such that the medical device includes a first portion positioned within a vasculature and a second portion positioned outside the patient's body, comprising: attaching the access sleeve to a second portion of the medical device via a first lumen; positioning the access sleeve within the vasculature by sliding the access sleeve along the medical device, the medical device serving as a rail to guide the access sleeve, the access sleeve being adjacent to the first portion of the medical device when positioned within the vasculature; and Removing the medical device A method comprising: [The present invention 1026] the access sleeve further comprising a second lumen having a stylet; and 1026. The method of claim 1025, wherein said method further comprises the step of removing said stylet from said second lumen once said access sleeve is positioned within said vasculature. [The present invention 1027] inserting a guidewire into the second lumen of the access sleeve such that a distal portion of the guidewire extends beyond the access sleeve and into the vasculature. The method of the present invention 1026 further comprising: [The present invention 1028] removing the access sleeve while maintaining the position of the guidewire within the vasculature. The method of the present invention 1027 further comprising: [The present invention 1029] Removing the medical device from the vascular site. The method of the present invention 1028 further comprising: [The present invention 1030] removing the access sleeve while maintaining the position of the guidewire within the vasculature; and Removing the medical device from the vascular site. The method of the present invention 1027 further comprising: [Brief explanation of the drawings]

[0015] These and other objects and advantages will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout.

[0016] [Figure 1] 1 is an isometric view of an exemplary medical device according to the prior art. [Figure 2] FIG. 1 is a longitudinal cross-sectional view of an access sleeve according to one embodiment of the present disclosure. [Figure 3] FIG. 3 is an isometric view of the access sleeve of FIG. 2 attached to a medical device. [Figure 4] 3 is a cross-sectional view of the exemplary access sleeve of FIG. 2. [Figure 5] 3 is an isometric view of a proximal portion of the access sleeve of FIG. 2 attached to the medical device of FIG. 1. [Figure 6] 3 is an isometric view of a distal portion of the access sleeve of FIG. 2 attached to the medical device of FIG. 1. [Figure 7] 3 is a cross-sectional view of a second embodiment of the exemplary access sleeve of FIG. 2. [Figure 8] FIG. 3 is a cross-sectional view of a third embodiment of the exemplary access sleeve of FIG. 2. [Figure 9] FIG. 3 is a cross-sectional view of a fourth embodiment of the exemplary access sleeve of FIG. 2. [Figure 10] 3A-3C illustrate an exemplary method for attaching the guidewire access sleeve of FIG. 2 to the medical device of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0017] Detailed Description Certain exemplary embodiments will be described so that the systems, methods, and devices described herein can be fully understood. While the embodiments and features described herein are specifically described for use in connection with a percutaneous heart pump system, it will be understood that all components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to other types of medical devices, such as transcatheter aortic valve replacement (TAVR) delivery systems, cardiac therapy devices, and cardiac assist devices, including balloon pumps and cardiac assist devices implanted using a surgical incision.

[0018] The systems, methods, and devices described herein provide an access sleeve for attachment to a medical device (e.g., a percutaneous heart pump) after the medical device has been inserted into a blood vessel through a vascular opening, i.e., to an indwelling medical device. The access sleeve of the present invention includes a tubular sleeve body extending along a longitudinal axis and having a first open end and a second open end. The access sleeve also includes an opening in the sleeve body connecting the first lumen to the outer surface of the sleeve body. The access sleeve is configured to be attached to a medical device without requiring access to the first or second ends of the medical device, such that vascular access to the patient is maintained by the access sleeve after removal of the medical device. In certain embodiments, the sleeve body may include a second lumen for a guidewire.

[0019] The openings in the sleeve body allow the access sleeve to be attached in-line to a medical device without requiring access to the end of the medical device. This configuration eliminates the need for the medical device to be threaded through the access sleeve, making the device compatible with a wide range of medical devices. Furthermore, the sleeve is made of a flexible material, meaning the arms of the sleeve can bend and flex to accommodate medical devices of various diameters and return to their original shape after the medical device is removed. This allows the sleeve to slide along the medical device while still attached to the device. This also allows for the passage of medical devices with a cross-section larger than the diameter of the first lumen of the access sleeve for the purpose of removing the medical device from the patient's vasculature. The resilience of the arms of the access sleeve also minimizes the formation of voids between the sleeve body and the medical device. This reduces the likelihood of fluid and blood becoming trapped in such voids, which can lead to undesirable hemostasis and clotting within the first lumen.

[0020] FIG. 1 illustrates an exemplary medical device, such as a percutaneous pump 100, according to certain embodiments. The pump 100 includes a pump handle 110, a pump head 130, a catheter 120 connecting the pump handle 110 to the pump head 130, and a connection hub 160. The catheter 120 is tubular and has a substantially uniform outer diameter 150. The catheter 120 provides electromechanical communication between the pump head 130 and the pump handle 110. The pump handle 110 is in communication with control circuitry that enables control of the pump head 130. The pump head 130 contains electromechanical components 10 that enable the device to perform various tasks within a patient's body, such as pumping blood from a location within the body. The pump head 130 has a diameter 140 that is larger than the diameter 150 of the catheter 120. An example of such a percutaneous pump is the Impella 2.5™ system (Abiomed, Inc., Danvers, Massachusetts). It will be understood that although a percutaneous heart pump is described herein, other percutaneous medical devices may be used in connection with the present disclosure.

[0021] FIG. 2 illustrates a cross-sectional view of an exemplary access sleeve 200 according to certain embodiments of the present disclosure. The access sleeve 200 includes a sleeve body 210 having a longitudinal axis 205. The sleeve body 210 defines a lumen 215 between a distal end 220 and a proximal end 230. The sleeve body 210 (and thus the lumen 215) has an inner diameter 218. The distal end 220 has an open end 225, and the proximal end 230 has an open end 235, thereby defining an inner surface and an outer surface. The lumen 215 provides a passageway for a medical device, such as the percutaneous pump 100 of FIG. 1. In some embodiments, the access sleeve 200 may have more than one lumen 215. For example, the access sleeve 200 may have two lumens: a lumen 215 for passing the deployment catheter 120 of the medical device 100 and a separate peripheral lumen 216 for passing a guidewire. In certain embodiments, the sleeve body 210 may be tubular. In other embodiments, a flexible tip 240 having an internal lumen 242 and an open distal end 245 is attached to the distal end 220 of the sleeve body 210. In this manner, the lumen 215 of the sleeve body 210 is in fluid communication with the lumen 242 of the tip 240, such that a continuous passageway is formed from the proximal open end 235 of the sleeve body 210 to the distal open end 245 of the tip 240. Additionally, the outer peripheral lumen 216 terminates in a side opening 217 at the tip 240. In some embodiments, the tip 240 is integrally formed with the tubular sleeve body 210. In certain embodiments, the access sleeve 200 includes an opening 260 extending longitudinally along the sleeve body 210. The opening 260 connects the lumen 215 to the outer surface of the sleeve body 210, such that the cross section of the access sleeve 200 is substantially C-shaped. In certain embodiments, opening 260 comprises a slit extending the entire length of sleeve 200. In certain embodiments, access sleeve 200 may also include a hub 250 coupled to proximal end 230 of sleeve body 210 to secure proximal end 230 of sleeve 200 to a patient. Hub 250 also facilitates insertion of a guidewire from proximal end 230 of access sleeve 200 into peripheral lumen 216.

[0022] The attachment of the access sleeve 200 to a medical device, such as the percutaneous pump 100 shown in FIG. 1, will now be described with reference to FIG. 3. FIG. 3 illustrates a representative patient anatomy, including an artery 320, subcutaneous tissue 310, and a skin layer 340, with the pump 100 inserted into the patient's vasculature, such as the depicted blood vessel (only the placement catheter 120 for the pump 100 is shown). The pump 100 may be introduced into the patient's vasculature 320 via an arteriotomy 330 using known techniques. As noted, the catheter 120 provides the necessary fluid and electrical and mechanical connections between the pump head and the pump handle 110. Thus, when the pump head 130 is in place, a first portion of the catheter 120 resides within the patient's artery 320, a second portion of the catheter resides within the subcutaneous tissue 310, and a third portion of the catheter resides outside the patient's tissue, i.e., outside the skin layer 340. In FIG. 3, a first portion is distal to the arteriotomy 330 as shown by arrow B, a second portion is proximal to the arteriotomy 330 as shown by arrow C, and a third portion is external to the tissue as shown by arrow D.

[0023] Once used, the medical device 100 may need to be completely removed from the vasculature 320 to make way for another medical device. In the embodiments disclosed herein, access to the vasculature 320 may be maintained by the access sleeve 200 alone, by the access sleeve 200 in conjunction with a guidewire, or by a guidewire after removal of the access sleeve 200, all of which require attachment of the access sleeve 200 to the catheter body 120 of the medical device 100. Thus, to maintain access to the vasculature 320 while the medical device is being removed, the access sleeve 200 is attached to the catheter body 120 of the medical device, and the sleeve is inserted into the patient's vasculature 320. To position the access sleeve 200 at the desired location, the sleeve is first attached to the portion of the deployment catheter that will be external to the tissue (shown by arrow D in FIG. 3 ). This attachment occurs via a slit 260 extending along the sleeve body 210 of the access sleeve 200. The slit 260 is opened by applying a separation force to the distal tip 220 of the sleeve body 210. This may be done with the physician's finger to create an opening large enough to accommodate the third portion of the catheter body 120 of the medical device 100; that is, the opening must be larger than the outer diameter 150 of the catheter body 120. In an alternative embodiment, attachment of the access sleeve 200 to the catheter body 120 is achieved by a press fit, in which the access sleeve 200 is pressed against the portion of the catheter body 120 that is external to the tissue, and flexing of the catheter body 120 facilitates attachment of the remaining length of the access sleeve 200. This opening of the slit 260 is possible depending on various factors, such as the nature of the material used to fabricate the access sleeve 200, the geometry of the access sleeve 200, the cross-sectional shape of the access sleeve 200, the location of the slit 260 on the cross-section of the access sleeve 200, and the slit width, as discussed in subsequent sections.Next, the sleeve body 210 of the access sleeve 200 is pressed against the third portion of the catheter body 120 through the slit 260 until the catheter body 120 is positioned within the lumen 215 of the sleeve body 210. Once this occurs, the remaining length of the access sleeve 200 is attached to the third portion of the catheter body 120 until the entire sleeve body 210 coaxially surrounds the catheter body 120. This may be accomplished by applying a longitudinal force on the proximal end 230 of the sleeve body 210 until the entire sleeve body 210 slides into place on the catheter body 120. The access sleeve 200 can thus be attached in-line to the percutaneous pump 100 without access to the end of the catheter 120, i.e., without access to the pump head 130. This can also be advantageous when a medical device, such as the percutaneous pump 100, does not have a lumen extending therethrough for passing a guidewire.

[0024] When the access sleeve 200 is fully attached to the catheter body 120, it acts as a cuff around the catheter body 120. The attached access sleeve 200 may then be placed within the patient's vasculature 320 by sliding it along the catheter body 120 from the third section, through the second section, to the first section; the access sleeve 200 is then guided by the catheter body 120 into the arteriotomy 330. In this manner, the catheter body 120 effectively serves as a guide rail for longitudinal positioning of the access sleeve 200 along the catheter body 120. Entry into the arteriotomy 330 is guided by the catheter body 120 but is also further aided by the atraumatic tip 240 attached to the distal end 220 of the sleeve body 210 of the access sleeve 200. Specific features of the tip 240 that enable this ease of placement are discussed in a subsequent section. 3, the access sleeve 200 has an outer peripheral lumen 216 (not shown) created within the sleeve body 210 for, for example, passage of a guidewire. The outer peripheral lumen 216 terminates in a side opening 217 at the tapered region of the distal end 240.

[0025] The access sleeve 200 comprises a rigid material, such as a high density polyethylene 10 (HDPE) material, a medium density polyethylene (MDPE) material, a low density polyethylene (LDPE) material, a polyether block amide (such as PEBA), a material with an elastic modulus of approximately 81-307 MPa, and a material with a yield strain of 20-30%.

[0026] FIG. 4 shows a cross-sectional view of the access sleeve 400 taken along section A-A' in FIG. 2. The access sleeve 400 has two lumens: a main lumen 215 for mounting onto the catheter 120 of the medical device as described with respect to FIG. 2, and a smaller peripheral lumen 216 for passing, for example, a guidewire. The peripheral lumen 216 is formed within the wall of the sleeve body 210 and is separate from the main lumen 215. However, in certain embodiments, the peripheral lumen 216 may merge with the main lumen 215 to form a track that runs alongside the main lumen 215. While the peripheral lumen 216 is shown in FIG. 4 as having a circular cross-section, it will be understood that the peripheral lumen 216 may have any cross-sectional shape. The diameter 218 of the peripheral lumen 216 is smaller than the diameter of the main lumen 215. The main lumen 215 has a diameter 218 that is substantially similar to the diameter 150 of the catheter body 120 so that the access sleeve 200 and catheter body 120 have either a loose or interference fit while allowing the catheter body 120 to move longitudinally relative to the access sleeve 200. This seals the main lumen 215 and minimizes (or even eliminates) the passage of fluid in the space that develops between the sleeve body 210 and the catheter body 120 during insertion; such fluid could solidify and block the main lumen 215 of the access sleeve 200. The diameter 218 of the main lumen 215 is also smaller than the diameter of the pump head 130. Thus, when it becomes necessary to fully remove the percutaneous pump 100 from the arteriotomy, the slit 260 allows the access sleeve 200 and lumen 215 to expand so that the pump head 130 can be moved longitudinally within the expanded lumen and retrieved. The access sleeve returns to its original size after withdrawal of the pump 100. Such expansion and contraction of the sleeve 200 is also due to the flexibility of the material used for the access sleeve 200.

[0027] The slits 260 are created as openings in the sleeve body 210 and extend longitudinally along the length of the access sleeve 200. In certain embodiments, the slits 260 are straight cuts extending parallel to the longitudinal axis 205 of the access sleeve 200, as shown in FIG. 5 . Such straight slits 260 simplify the construction of the access sleeve 200. In other embodiments, the slits extend in a spiral pattern relative to the longitudinal axis 205 of the sleeve 200. Such spiral slits 260 provide a higher level of flexibility while increasing the access sleeve 200's resistance to kinking around bends when inserted into a patient's arteriotomy. The spiral slits 260 in the access sleeve 200 also prevent detachment from the medical device. Additionally, the spiral slits 260 provide additional strength to the access sleeve 200.

[0028] In some embodiments, the inner surface of the sleeve body 210 may have an irregular geometry to minimize contact with a medical device (e.g., medical device 100) being advanced through the main lumen 215. Such an irregular geometry may include structure across at least a portion of the longitudinal length of the sleeve body 210. Such structure may include, for example, ribs, protrusions, or indentations that reduce the amount of contact between the inner surface 204 of the sleeve body 210 and the medical device 100 being advanced through the main lumen 215. In one embodiment, the inner surface 204 of the sleeve body 210 may be provided with at least one rib or protrusion extending along at least a portion of the longitudinal length of the sleeve 210. Such structure may appear as a raised feature protruding from the inner surface of the sleeve body 210. In other embodiments, the inner surface of the sleeve body 210 may be provided with at least one indentation extending along at least a portion of the longitudinal length of the sleeve 210. Such structures may appear as recessed features that appear as depressions on the interior surface of sleeve body 210. In further embodiments, a combination of protrusions and depressions may be provided along at least a portion of the longitudinal length of sleeve body 210.

[0029] In certain embodiments, raised features (e.g., protrusions) on the inner surface of the sleeve body 210 may additionally prevent axial rotation of the catheter body 210 while it is moving within the main lumen 215. Such protrusions may mate with grooves on the catheter body 210 such that when the access sleeve 200 is attached to the catheter body 210, the protrusions on the inner surface of the sleeve body 210 engage corresponding grooves on the catheter body 210, thereby preventing axial rotation of the medical device 100 as it moves within the access sleeve 200.

[0030] The access sleeve 200 may be used alone (i.e., without the need for a guidewire) to maintain access to the blood vessel 320 when the pump 100 is retrieved or repositioned. In certain cases, more space may be needed within the blood vessel 320 for other medical devices, and therefore a guidewire may be used in conjunction with the access sleeve 200, after which the access sleeve 200 may be removed, leaving only the guidewire to maintain access to the blood vessel 320. The guidewire is inserted into the peripheral lumen 216 in the access sleeve 200 after the access sleeve is attached to the catheter body 120. Like the main lumen 215, the diameter of the peripheral lumen 216 is such that it establishes a loose or interference fit with the guidewire while allowing longitudinal movement of the guidewire relative to the access sleeve 200. This prevents fluid from being drawn into the peripheral lumen 216, which could clot and block the peripheral lumen. Alternatively, a guidewire may be preloaded into the peripheral lumen 216 of the access sleeve 200 prior to attachment of the access sleeve 200 to the catheter body 120. When preloaded, such a guidewire may provide additional mechanical strength to the access sleeve. As shown in FIG. 5 , the peripheral lumen 216 terminates in a side opening 217 at the tip 240.

[0031] In certain aspects, a guidewire lumen stylet may be inserted into the peripheral lumen 216 to block the peripheral lumen 216 until the physician is ready to use the peripheral lumen 216 to pass a guidewire. Such a stylet prevents blood leakage. The stylet has a clearance fit with the peripheral lumen 216 and does not protrude from the outer surface of the distal end of the access sleeve (e.g., the stylet does not protrude from the side opening 217 in the tip 240). This is believed to prevent the stylet from snagging tissue when the access sleeve 200 is positioned within the patient's vasculature. In some embodiments, the access sleeve 200 may be made without a peripheral lumen 216.

[0032] In certain embodiments, the sleeve body 210 may include integral support structures to enhance retention of the access sleeve 200. Such support structures may also increase the overall stiffness of the sleeve 200. In some embodiments, such support structures may take the form of superelastic wires arranged longitudinally along the length of the sleeve body 210. In certain embodiments, nitinol wires are used. Such support structures are incorporated into the sleeve body 210 during fabrication of the access sleeve 200.

[0033] FIG. 6 shows an atraumatic tip 240 attached to the access sleeve 200. Referring to FIGS. 2 and 6, the tip 240 is attached to the distal end 220 of the sleeve body 210 and has an internal lumen 242 and an open distal end 245 attached to the distal end 220 of the sleeve body 210. The proximal end 244 of the tip 240 is coupled to the distal end 220 of the sleeve body 210 so that the lumens 215 and 242 seamlessly communicate with each other. This allows the medical device 100 to easily pass through the access sleeve 200. The inner surface of the tip 240 is slightly tapered so that the inner diameter is larger at the proximal end 244 of the tip 240 than at the distal end 245 of the tip 240. This creates a slight interference fit with the medical device 100. This slight interference of the distal tip 240 with the medical device 100 helps seal against fluid or blood from entering the opening at the distal end 245 and, therefore, the lumen 215. The outer surface of the tip 240 also tapers toward the distal end 245, such that the outer diameter is larger at the proximal end 244 than at the distal end 245. As shown in FIG. 5 , the outer peripheral lumen 216 terminates in a side opening 217 at the tip 240. The distal end 244 of the tip 240 terminates in a leading edge 246. The outer diameter of the leading edge 246 has a radius that facilitates smooth insertion of the access sleeve 200 into the patient's vasculature 320. The tip 240 is highly resilient and does not exhibit permanent deformation (such as flaring or splitting). In certain embodiments, the tip 240 comprises the same flexible material as the sleeve body 210. Additionally, as a result of the tapered surface of tip 240, the wall of tip 240 thins towards distal end 245. This increases the flexibility of tip 240 and allows for less traumatic retrieval of oversized medical devices from the patient's vasculature.

[0034] In some embodiments, the proximal end 230 of the access sleeve 200 may be coupled to a hub 250. The hub 250 has an internal conduit 252 that is in fluid communication with the main lumen 215 of the access sleeve 200 when the hub assembly 250 is coupled to the sleeve body 210. The internal conduit 252 has a diameter 256. In certain embodiments, the hub 250 has a passageway 254 that is collinear with the outer peripheral lumen 216 when the access sleeve 200 is connected to the hub 250. The passageway 254 provides a user with a defined entrance for inserting a guidewire into the outer peripheral lumen 216 after the access sleeve 200 has been inserted into the patient's vasculature 320. In certain embodiments, the hub 250 may also have an opening or slit (not shown) that allows passage of a medical device 100 having a diameter larger than the diameter 256 of the conduit 252. In other embodiments, the proximal end of the hub 250 may be configured to mate with the handle 110 of the medical device 100. Hub 250 may also have attachment features (e.g., wings or suture holes) that allow access sleeve 200 to be secured to a patient. In certain embodiments, the hub may make it easier for a user to grip access sleeve 200 on medical device 100. In other embodiments, the hub may also contain a hemostatic valve. The hub and hemostatic valve may contain slits or equivalent side openings that facilitate attachment of the access sleeve (coupled to the hub) to the medical device.

[0035] Hub 250 may include a rigid material. The rigid material is a polyethylene or polyurethane material having a modulus of elasticity of approximately 40 ksi. In some embodiments, the rigid material is any one of a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, polyetheretherketone (PEEK), and a polyether block amide (e.g., PEBAX). In certain embodiments, the rigid material is a crack-resistant material. In some embodiments, the rigid material may also have a low coefficient of friction.

[0036] Alternative embodiments of the present disclosure are illustrated without further elaboration with reference to FIGS. 7-9. FIG. 7 shows a cross section of an alternative access sleeve 700 in a specific embodiment. The access sleeve 700 contains similar features to the access sleeve 200 shown in FIG. 2. The access sleeve 700 includes a sleeve body 710 having a main lumen 725 for passage of a medical device, such as the percutaneous pump 100, and an outer peripheral lumen 750 for passage of a guidewire. Instead of a slit, the access sleeve 700 includes an opening 760 connecting the main lumen 725 to the outer surface of the sleeve body 710, thereby allowing for in-line and sustained attachment to the medical device. The access sleeve 700 includes arms 715 that define the main lumen 725 and the opening 760. Similar to the access sleeve 200, the sleeve body 710 is also made of a flexible, resilient material so that the arms 715 can bend open and return to their original shape to allow attachment to the medical device. 2, it is easier to attach the access sleeve 700 to the medical device and has a clipping effect due to the flexibility of the arms 715. The clipping effect ensures that no space occurs between the inner surface of the main lumen 725 and the medical device. This prevents blood flow between the access sleeve 700 and the medical device, which can lead to clotting and blockage of the main lumen 725.

[0037] FIG. 8 shows a cross-section of a further alternative access sleeve 800 in certain embodiments. The access sleeve 800 comprises a sleeve body 810 having a lumen 825 for passing a medical device and an opening 860 connecting the lumen 825 to the exterior of the sleeve body 810. This configuration allows for in-line attachment of the sleeve body 810 to the medical device. The lumen 825 and opening 860 are defined by arms 815 that run the length of the access sleeve 800. The arms 815 have rounded edges 820 to help facilitate smooth attachment to the medical device and minimize trauma to the vasculature during insertion. Unlike the previous embodiment, the access sleeve 800 does not contain an outer peripheral lumen for a guidewire. Instead, the diameter of the lumen 825 is selected so that the access sleeve 800 can accommodate both the medical device and a guidewire, if a guidewire is required during use. The access sleeve 800 has a simple structure and is therefore easy to fabricate.

[0038] FIG. 9 shows a cross-section of another alternative access sleeve 900 in certain embodiments. The access sleeve 900 includes a sleeve body 910 having a lumen 925 for passing a medical device therethrough and an opening 960 connecting the lumen 925 to the exterior of the sleeve body 910. This configuration allows for in-line attachment of the sleeve body 910 to the medical device. The access sleeve 900 also includes a track or recess 930 that protrudes from the surface of the lumen 925 toward the interior of the sleeve body 910. When the access sleeve 900 is attached to the medical device, the track or recess 930 forms a guided insertion path for a guidewire. The lumen 925 and opening 960 are defined by arms 915; each arm 915 has rounded edges 920 to help facilitate smooth attachment to the medical device and minimize trauma to the vasculature during insertion.

[0039] FIG. 10 illustrates an exemplary method 1000 using any of the previously described access sleeves 200, 700, 800, and 900, or any other suitable access sleeve. Method 1000 is described below with respect to access sleeve 200, but may be applied to any of the access sleeves described herein. As discussed in the preceding sections, access sleeves according to the present disclosure are used in conjunction with medical devices, such as percutaneous heart pump 100. Such medical devices have a catheter body 120 and are inserted into a patient's vasculature to perform a function at an access site, with a first portion of the placement catheter outside the vasculature, while a second portion of the placement catheter is positioned at the access site. After performing its function, the medical device may need to be completely removed from the vasculature or repositioned (or reloaded) while maintaining access to the vasculature.

[0040] In step S1010, the distal portion 220 of the access sleeve 200 is attached to the first portion of the catheter body 120 by applying a separation force to the distal tip 220 of the sleeve body 210 to open the slit 260. The sleeve body 210 of the access sleeve 200 is pressed against the second portion of the catheter body 120 through the slit 260 until the catheter body 120 is positioned within the lumen 215 of the sleeve body 210. Once this occurs, the remaining length of the access sleeve 200 is attached to the second portion of the catheter body 120 until the entire sleeve body 210 coaxially surrounds the catheter body 120. This may be accomplished by applying a longitudinal force on the proximal end 230 of the sleeve body 210. In this manner, the access sleeve 200 is attached in-line to the percutaneous pump 100 without access to the end of the catheter 120, i.e., without access to the pump head 130.

[0041] In step S1020, the access sleeve 200 is positioned within the patient's vasculature by sliding it along the catheter body 120; the access sleeve is then guided into the access site by the catheter body 120. The catheter body 120 effectively serves as a guide rail for longitudinally positioning the access sleeve 200 along the catheter body 120. In certain embodiments, a guidewire may additionally be inserted into the peripheral lumen 216 of the access sleeve to gain access to the access site. The guidewire is inserted into the peripheral lumen 216 via a hub 250 located at the proximal end 230 of the access sleeve 200.

[0042] In step S1030, after the access sleeve (and guidewire, if necessary) is positioned at the desired location within the patient's vasculature, the percutaneous pump 100 is removed or repositioned as needed. As previously mentioned, the diameter 218 of the lumen 215 may be smaller than that of the pump head 130. Thus, upon removal or repositioning of the pump 100, the slit 260 allows the access sleeve 200 and lumen 215 to expand so that the pump head 130 can be retrieved by moving longitudinally within the expanded lumen. After retrieval of the pump 100, access to the access site is maintained by the access sleeve 200 (or the guidewire, if present, or both).

[0043] In certain embodiments, prior to removing the medical device in step 1030, the guidewire lumen stylet is removed from the outer peripheral lumen 216 of the access sleeve 200 (step S1040). Once the guidewire lumen stylet has been removed, a guidewire is inserted into the outer peripheral lumen 216 of the access sleeve 200, as shown in step S1050. The guidewire is inserted such that a distal portion of the guidewire extends beyond the access sleeve and into the patient's vasculature. At that point, the access sleeve 200 is removed (step S1060), and, if desired, the medical device 100 is removed (step S1070), thereby leaving only the guidewire to maintain access to the patient's vasculature. In certain embodiments, once the guidewire is positioned within the vasculature (step S1050), both the access sleeve 200 and the medical device 100 are removed together, leaving only the guidewire to maintain access to the patient's vasculature (step S1080).

[0044] In light of the above, it will be appreciated by those skilled in the art that the present disclosure provides a means of maintaining access to a patient's arteriotomy during use of a repositioning sleeve and / or removal of a placement pump without having access to the distal (detention) end of these devices.

[0045] The foregoing is merely illustrative of the principles of the present disclosure, and the systems, methods, and devices of the present invention may be practiced in other ways than those described herein; the ways described herein are presented for purposes of illustration and not limitation. It should be understood that the systems, methods, and devices disclosed herein, while shown for use in a system for a percutaneous heart pump, may also be applied to systems, methods, and devices for other implantable heart pumps or implantable cardiac assist devices.

[0046] Variations and modifications will occur to those skilled in the art after reviewing this disclosure. The various features described or illustrated above, including any components thereof, may be combined or integrated into other systems. Additionally, certain features may be omitted or not implemented. The various embodiments described or illustrated above may be combined in any manner.

[0047] Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made a part of this application.

Claims

1. 1. A vascular access sleeve comprising: a sleeve body extending along a longitudinal axis of the access sleeve and having first and second open ends; a hub attached to the second open end of the sleeve body, the hub having third and fourth open ends and further including a hemostasis valve; a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body and further extending between the third and fourth open ends of the hub; a second lumen extending parallel to the longitudinal axis between the first and second open ends of the sleeve body and forming a track extending alongside the first lumen; a first side opening in the sleeve body, the hub, and the hemostasis valve, the first side opening extending from the first open end to the second open end of the sleeve body and from the third open end to the fourth open end of the hub; a second side opening between the first lumen and the second lumen, the second side opening extending from the first open end to the second open end of the sleeve body; Equipped with the first side opening is expandable and configured to allow attachment of the access sleeve to the medical device between the first and second ends of the medical device such that at least a portion of the medical device is received within the first lumen; and the first side opening and the second side opening are configured to permit attachment of the access sleeve to the guidewire between the first end and the second end of the guidewire such that the guidewire is received within the second lumen. Access sleeve.

2. The access sleeve of claim 1 , wherein at least one edge of the first side opening is rounded.

3. The access sleeve of claim 1 , wherein the first side opening extends linearly between the first and second open ends of the sleeve body and is parallel to a longitudinal axis of the first lumen of the sleeve body.

4. The access sleeve of claim 1 , wherein the first side opening extends in a helical, spiral manner between the first and second open ends of the sleeve body.

5. 2. The access sleeve of claim 1, wherein the sleeve body comprises an inner surface having an irregular geometric shape configured to reduce contact between the sleeve body and the medical device, the irregular geometric shape including at least one rib, protrusion, or indentation spanning at least a portion of the longitudinal length of the sleeve body.

6. The access sleeve of claim 1 , wherein the hub further comprises wings or suture holes configured to allow the hub to be secured to a patient.

7. 2. The access sleeve of claim 1, further comprising a tip at a first open end of the sleeve body, the tip having an inner surface defining a tip lumen extending between a proximal end and a distal end of the tip, the tip lumen being in fluid communication with the first lumen of the sleeve body.

8. 8. The access sleeve of claim 7, wherein an outer diameter of the proximal end of the tip is greater than an outer diameter of the distal end of the tip such that the tip is tapered along its length.

9. The access sleeve of claim 7, wherein a diameter of an inner surface of the tip at a proximal end thereof is greater than a diameter of an inner surface of the tip at a distal end thereof.

10. The access sleeve of claim 7, wherein the diameter of the inner surface at the proximal end of the tip is equal to the diameter of the inner surface at the distal end of the tip.

11. The access sleeve of claim 7 , wherein the sleeve body comprises a first material and the tip comprises a second material.

12. The access sleeve of claim 11 , wherein the first material is stiffer than the second material and the second material is more elastic than the first material.

13. 12. The access sleeve of claim 11, 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 a modulus of elasticity of about 81 to 307 MPa, or a material having a yield strain of 20 to 30%.

14. The second material may be ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), synthetic rubber, elastomer, elastic material, having a modulus of elasticity of about 1600 psi (1.103 x 10 7 12. The access sleeve of claim 11, comprising at least one of a material with a yield strain of greater than 200% or a material with a yield strain of greater than 200%.

15. 7. The access sleeve of claim 6, wherein the 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).

16. 1. An access system comprising: a medical device configured to be inserted into an arteriotomy in a patient, the medical device having a first end and a second end; an access sleeve having a sleeve body extending along a longitudinal axis and having first and second open ends; a hub attached to the second open end of the sleeve body, the hub having third and fourth open ends and further including a hemostasis valve; a first lumen extending along the longitudinal axis between the first and second open ends of the sleeve body and further extending between the third and fourth open ends of the hub; a second lumen extending parallel to the longitudinal axis between the first and second open ends of the sleeve body and forming a track extending alongside the first lumen; a first side opening in the sleeve body, the hub, and the hemostasis valve, the first side opening extending from the first open end to the second open end of the sleeve body and from the third open end to the fourth open end of the hub; a second side opening between the first lumen and the second lumen, the second side opening extending from the first open end to the second open end of the sleeve body; Equipped with the first side opening is expandable and configured to allow attachment of the access sleeve to the medical device between the first end and the second end of the medical device such that at least a portion of the medical device is received within the first lumen; and the first side opening and the second side opening are configured to permit attachment of the access sleeve to the guidewire between the first end and the second end of the guidewire such that the guidewire is received within the second lumen. Access system.

17. 17. The access system of claim 16, wherein the medical device comprises a catheter, and the first side opening is configured to allow attachment of the access sleeve to the catheter.

18. 18. The access system of claim 17, wherein the first lumen of the sleeve body is configured to allow the access sleeve to be advanced distally along the catheter and into an arteriotomy in a patient when attached to the catheter.

19. 17. The access system of claim 16, wherein at least one edge of the first side opening is rounded.

20. 17. The access system of claim 16, wherein the sleeve body comprises an inner surface having an irregular geometry configured to reduce contact between the sleeve body and the medical device, the irregular geometry including at least one rib, protrusion, or indentation spanning at least a portion of the longitudinal length of the sleeve body.

21. 17. The access system of claim 16, wherein the hub further comprises wings or suture holes configured to allow the hub to be secured to a patient.

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