Access sheath system devices and methods

Abstract

An access sheath system is provided that includes an access sheath and a dilator. For example, the access sheath is sized and shaped to be introduced into an artery and can include a protective distal end having an atraumatic surface. The dilator includes an atraumatic tip and a guide sheath. The atraumatic tip can include a proximal portion configured to extend along a sheath passageway of the guide sheath and a distal portion having a distal tapered surface. The atraumatic tip is configured to engage and cover at least a portion of the distal end of the guide sheath to protect the artery from the distal end of the guide sheath.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 322,065, filed March 21, 2022, entitled "Access Sheath System Apparatus and Method," which is incorporated by reference in its entirety herein. [Background technology]

[0002] Interventional procedures are performed to treat vascular diseases, such as stenosis, occlusions, aneurysms, fistulas, etc. Interventional procedures are also used to perform procedures on organ or tissue targets accessible via blood vessels, such as denervating or ablating tissue to intervene in nerve conduction, embolizing blood vessels to restrict blood flow to tumors or other tissues, delivering drugs, contrast agents, or other agents to intravascular or extravascular targets for therapeutic or diagnostic purposes, etc. Interventional procedures are typically divided into coronary, neurovascular, and peripheral vascular categories. Most procedures are performed in the arterial system via arterial access sites.

[0003] Methods of accessing arteries to perform these procedures are well established and fall into two broad categories: percutaneous access and surgical incision. The majority of interventional procedures utilize percutaneous access. In this access method, a needle punctures the skin, passes through the subcutaneous tissue and muscle layers, and through the vessel wall to reach the vessel. Vascular ultrasound is often utilized to image the vessel and surrounding structures and facilitate precise insertion of the needle into the vessel. In some cases, micropuncture or microaccess techniques are utilized, where the vessel is first accessed with a small gauge needle, followed by dilating the vessel with a 4F micropuncture cannula and placing a sheath guidewire through the cannula. Once the guidewire is in place, an access sheath and sheath dilator can be inserted into the artery over the guidewire.

[0004] In a surgical incision, the skin is incised and tissue is removed down to the level of the target artery. Depending on the size of the artery and the size of the access device, the vessel wall is either incised with a blade or directly punctured with an access needle through which a sheath guidewire is placed. As described above, an access sheath and sheath dilator are inserted into the artery over the sheath guidewire. Once the access sheath is in place, the dilator and sheath guidewire are removed. Devices can now be introduced into the artery through the access sheath and advanced to the target site using standard interventional techniques and fluoroscopy to perform the procedure. Summary of the Invention [Problem to be solved by the invention]

[0005] Access to the target site is achieved through an arterial access site that is advanced through the skin. For example, some endovascular devices are specifically designed for femoral access sites. Other access sites include the radial, brachial, carotid, and axillary arteries. These access sites involve smaller arteries than the femoral artery and may include tortuosity and distances between the access site and the target site.

[0006] Concerns and potential problems when inserting an access device into a blood vessel include causing undesired damage to the blood vessel. For example, during dilation and access to the blood vessel, access sheaths that include stiff, angled, and / or sharp distal ends may be used, which may cause dissection and / or damage to the blood vessel. Such dissection and damage to the blood vessel may lead to surgical complications, harm the patient, and prolong the procedure. [Means for solving the problem]

[0007] Aspects of the present subject matter can include embodiments of an access sheath system including various embodiments of a dilator. In one aspect, the access sheath system includes an access sheath including an elongate sheath body sized and shaped to be introduced into an artery. The access sheath can include a protective distal end having an atraumatic surface, the elongate sheath body can include a lumen extending between a proximal sheath end and a distal sheath end. The access sheath system can further include a dilator including an atraumatic tip and a guide sheath. The atraumatic tip can include a proximal portion and a distal portion. The proximal portion of the atraumatic tip can be configured to extend along a sheath passageway of the guide sheath. The distal portion of the atraumatic tip can include a distal tapered surface, the atraumatic tip can be configured to engage and at least partially cover the distal end of the guide sheath to protect the artery from the distal end of the guide sheath.

[0008] In some variations, one or more of the following features may be optionally included in any feasible combination: The access sheath system may further include a guidewire sized to extend along at least the atraumatic tip dilator passage. The atraumatic tip of the dilator may include an inflatable balloon tip element. The inflatable balloon tip element may include a proximal stepped surface formed to engage and cover the distal end of the guide sheath when the inflatable balloon is in an inflated state. The inflatable balloon tip element may include a proximal section having a first outer diameter and a distal section having a second outer diameter, the first outer diameter may be smaller than the second outer diameter, and the proximal section may be formed to couple to the sheath passage. The atraumatic tip is movable along a longitudinal axis of the guide sheath relative to the guide sheath to form a first position and a second position of the dilator. The first position may include a proximal surface of the atraumatic tip engaging and at least partially covering the distal end of the guide sheath. The proximal surface can be a portion of a proximal stepped surface of the atraumatic tip, and the proximal stepped surface can be proximal to the tapered surface. When the expander is in the second position, the proximal stepped surface can be located away from the distal end of the guide sheath. The second position can include a flexible extension of the atraumatic tip, the flexible extension can be radially expanded and positioned along an outer surface of the distal end of the guide sheath. The sheath body of the access sheath includes at least one arm that can separate the sheath body into multiple portions when pulled away from a longitudinal axis of the sheath body.

[0009] In another aspect, a dilator for use with an access sheath system can include a guide sheath having a sheath passageway. The dilator can further include an atraumatic tip having a proximal portion and a distal portion. The proximal portion of the atraumatic tip can be configured to extend along the sheath passageway and the distal portion of the atraumatic tip can include a distal tapered surface. The atraumatic tip can be configured to engage and cover at least a portion of a distal end of the guide sheath to protect the artery from the distal end of the guide sheath.

[0010] In some variations, one or more of the following features may be optionally included in any feasible combination: The atraumatic tip may include a dilator passage that may allow a guidewire to extend along and through the atraumatic tip. The atraumatic tip of the dilator may include an inflatable balloon tip element. The inflatable balloon tip element may include a proximal stepped surface configured to engage and cover a distal end of the guide sheath when the inflatable balloon is in an inflated state. The inflatable balloon tip element may include a proximal section having a first outer diameter and a distal section having a second outer diameter, the first outer diameter may be smaller than the second outer diameter, and the proximal section may be configured to couple to the sheath passage. The atraumatic tip is movable along a longitudinal axis of the guide sheath relative to the guide sheath to form a first position and a second position. The first position may include a proximal surface of the atraumatic tip engaging and at least partially covering a distal end of the guide sheath. The proximal surface can be part of a proximal stepped surface of the atraumatic tip, and the proximal stepped surface can be proximal to the tapered surface. When the dilator is in the second position, the proximal stepped surface can be located away from the distal end of the guide sheath. The second position can include a flexible extension of the atraumatic tip, which can be radially expanded and positioned along an outer surface of the distal end of the guide sheath.

[0011] Another related aspect of the invention includes a method of advancing an access sheath into an artery. The access sheath can include a protective distal end having an atraumatic surface, and the elongate sheath body can include a lumen extending between the proximal and distal sheath ends. The method can further include advancing a dilator along the lumen of the access sheath. The dilator can include an atraumatic tip and a guide sheath. The atraumatic tip can include a proximal portion and a distal portion. The proximal portion of the atraumatic tip can be configured to extend along a sheath passageway of the guide sheath. The distal portion of the atraumatic tip can include a distal tapered surface, and the atraumatic tip can be configured to engage and at least partially cover the distal end of the guide sheath to protect the artery from the distal end of the guide sheath.

[0012] In some variations, one or more of the following features may be optionally included in any feasible combination. The method may further include advancing a guidewire along the dilator passage of the atraumatic tip. The atraumatic tip of the dilator may include an inflatable balloon tip element. The inflatable balloon tip element may include a proximal stepped surface configured to engage and cover the distal end of the guide sheath when the inflatable balloon is in an inflated state. The inflatable balloon tip element may include a proximal section having a first outer diameter and a distal section having a second outer diameter, the first outer diameter being smaller than the second outer diameter, the proximal section being coupled to the sheath passage. The method may further include moving the atraumatic tip relative to the guide sheath along a longitudinal axis of the guide sheath to form a first position or a second position. The first position may include a proximal surface of the atraumatic tip engaging and at least partially covering the distal end of the guide sheath. The proximal surface can be a portion of a proximal stepped surface of the atraumatic tip, and the proximal stepped surface can be proximal to the tapered surface. When the dilator is in the second position, the proximal stepped surface can be located away from the distal end of the guide sheath. The second position can include a flexible extension of the atraumatic tip, the flexible extension can be radially expanded and positioned along an outer surface of the distal end of the guide sheath. The sheath body of the access sheath includes at least one arm that can separate the sheath body into multiple portions when pulled away from a longitudinal axis of the sheath body.

[0013] Details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.

[0014] In the drawings, like reference numbers may be used to denote like structures, features, or elements. [Brief description of the drawings]

[0015] [Figure 1A] FIG. 1 is a side view of an embodiment of an access sheath system including an access sheath, a dilator, and a guidewire. [Figure 1B] FIG. 1B illustrates the use of the access sheath of FIG. 1A to access a blood vessel to perform a procedure. [Figure 2A] 1 is a side cross-sectional view of another embodiment of an access sheath system including an access sheath and a dilator according to the present invention; [Figure 2B] 2B is a side view of the access sheath system of FIG. 2A including one embodiment of a guide sheath; [Figure 3A] FIG. 1 is a partial side cross-sectional view of an embodiment of a dilator including a balloon tip element and a guide sheath. [Figure 3B] 3B is a partial side view of the balloon tip element of FIG. [Figure 4A] FIG. 1 is a partial side view of an embodiment of a dilator in a first position, including a tapered tip element and an embodiment of a guide sheath. [Figure 4B] FIG. 4B is a partial side view of the dilator of FIG. 4A in a second position; [Figure 4C] FIG. 4C is a partial side cross-sectional view of the dilator in a second position of FIG. [Figure 5A] FIG. 1 is a side cross-sectional view of another embodiment of a dilator in a first position, including a flexible tapered tip element and a guide sheath of one embodiment. [Figure 5B] FIG. 5B is a partial side cross-sectional view of the dilator of FIG. 5A in a second position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Various embodiments of access sheath systems are disclosed that allow for safe and effective access to the vascular system, such as to perform various treatments accessed via a patient's vascular system. For example, the access sheath systems disclosed herein can include one or more of an access sheath, a dilator, and a guidewire. Additionally, embodiments of access sheaths and dilators with features that ensure safe access within and along a blood vessel are described herein. For example, some embodiments of the access sheaths and dilators described herein include features that prevent undesired damage to a blood vessel, such as a blood vessel wall, during and / or after insertion of the access sheath into the blood vessel.

[0017] The various access sheath systems disclosed herein (including the various access sheaths, dilators, and guidewires) may be used in any of a patient's various vasculature, including the femoral-radial, brachial, carotid, and axillary arteries, and therefore, any examples of devices, systems, and / or methods disclosed herein in connection with a particular access point and / or a particular vasculature are not limited to such particular access point and / or to a particular vasculature.

[0018] FIG. 1A illustrates a first embodiment of an access sheath system 200 including an access sheath for insertion into a blood vessel over a guidewire. Once inserted into the blood vessel, the access sheath allows for the introduction of at least one interventional device into the blood vessel through the access sheath lumen to perform an interventional procedure in a region of the vascular system. As shown in FIG. 1A, the access sheath system 200 includes an access sheath 220, a dilator 260, and a guidewire 215. The access sheath 220, the dilator 260, and the guidewire 215 are all adapted to be introduced into the carotid artery via an access site, for example, via a carotid puncture. The access site can be achieved percutaneously or by a surgical incision.

[0019] In one embodiment, some or all of the components of the access sheath system 200 may be combined into an access system kit. For example, one or more of the access sheath 220, the dilator 260, and the guidewire 215 may be combined into a single package, container, or collection of containers bundled together.

[0020] 1B illustrates an example of a procedure using the access sheath system 200, such as in the insertion of a carotid stent, in which the access sheath 220 is used to access the common carotid artery 310. As shown in FIG. 1B, the access sheath 220 can be inserted into the common carotid artery 310 through a surgical incision 315. The access sheath 220 can include a lumen with openings at a proximal end and a distal end or multiple regions of the access sheath 220. When the distal portion of the access sheath 220 is within the carotid artery and the proximal portion is outside the patient, the lumen can provide a passageway for inserting one or more interventional devices into the artery to perform various procedures.

[0021] 1A, an embodiment of an arterial access sheath 220 includes an elongated sheath body 222 and a proximal adaptor 224 at the proximal end of the sheath body 222. The sheath body 222 is part of the arterial access sheath 220 that is sized and shaped to be inserted into an artery, with at least a portion of the sheath body 222 actually being inserted into the artery during a procedure. The proximal adaptor 224 can include a hemostatic valve 226 and an elongated flush line 228 having a lumen that communicates with the lumen of the sheath body 222. The proximal adaptor 224 can have a larger diameter or cross-sectional dimension than the sheath body 222. The hemostatic valve 226 communicates with the lumen of the sheath body 222 to allow for introduction of devices therein and to prevent or minimize blood loss through the lumen during a procedure. For example, the hemostasis valve 226 can include a statically sealed passive valve, an adjustable aperture valve (e.g., a Tuohy-Borst valve), or a rotating hemostasis valve. In one embodiment, the outer diameter of the sheath body 222 is about 5 to 9 French, or 6 French, or 7 French. In one embodiment, the sheath body 222 has a lumen diameter of about 0.087 inches and an outer diameter of about 0.104 inches, corresponding to a 6 French sheath size. In another embodiment, the sheath body 222 has a lumen diameter of about 0.113 inches and an outer diameter of about 0.136 inches, corresponding to an 8 French sheath size. Other sizes and dimensions of the sheath body 222 are within the scope of this disclosure.

[0022] The access sheath 220 can further include a radiopaque marker 230, such as a radiopaque marker 230 disposed adjacent the distal end of the sheath body 222, as shown in FIG 1A. The radiopaque marker 230 can include a metal band, such as a platinum iridium alloy, embedded near the distal end of the sheath body 222. Alternatively, the material forming a portion of the sheath body 222 (e.g., the distal end of the sheath body 222) can include a radiopaque material, such as a barium polymer or a tungsten polymer blend.

[0023] As shown in FIG. 1A, the dilator 260 can include an elongated body that can be inserted into a blood vessel and can facilitate smooth insertion of the access sheath 220 through a puncture site in the vessel wall. The distal end of the dilator 260 can then be generally tapered so that the dilator 260 can be inserted into the artery over the guidewire 215 and can expand the access site to a larger diameter to allow the access sheath 220 to be inserted. To accommodate these functions, the dilator 260 can include a tapered end 268 with a rounded tip. For example, the dilator 260 can be secured to the access sheath 220 when assembled for insertion into the artery. The dilator 260 can include a proximal hub or cap 264 for coupling to a corresponding structure (e.g., hemostasis valve 226) of the arterial access sheath 220. The internal passage of the dilator 260 can accommodate the guidewire 215. For example, the dilator 260 can have a diameter of about 0.037 inches (in) to about 0.041 inches. In some embodiments, the dilator 260 can include one or more radiopaque markers 230, for example at the distal end. In one variation, the radiopaque marker 230 is a piece of tungsten-filled Pebax or polyurethane that is heat welded to the distal end of the dilator 260. Other radiopaque materials can be used to construct the radiopaque markers 230 as well.

[0024] In some embodiments, the guidewire 215 can have an atraumatic straight, angled, or J-shaped tip. The guidewire 215 can transition to a gradually stiffer segment at the proximal end. In some embodiments, the diameter of the guidewire 215 is about 0.035 inches or 0.038 inches. The guidewire 215 can have a variety of lengths and diameters without departing from the scope of the present disclosure.

[0025] The distal end of the sheath body 222 can be configured such that when the dilator 260 is coupled to the access sheath 220 (e.g., the dilator 260 extends along the lumen of the access sheath 220) to form the access sheath assembly 200, the access sheath assembly 200 can be smoothly inserted over the guidewire 215 through the access site (e.g., an arterial puncture) with minimal resistance. In some embodiments, the sheath body 222 can include a lubricious or hydrophilic coating to reduce friction during insertion into a blood vessel. For example, the coating can be limited to the distal-most portion of the sheath body 222 (e.g., 0.5 centimeters (cm) to 3 cm of the elongated sheath body 222). This can facilitate insertion without compromising the safety of the access sheath 220 at the puncture site or the ability of the operator to firmly grip the access sheath 220 during insertion. In some embodiments, the access sheath 220 does not include a coating. In some embodiments, the dilator 260 includes a coating, for example along the distal end.

[0026] 1A, in one embodiment, the access sheath 220 has features that aid in securing the access sheath 220 during a procedure. For example, the access sheath 220 may include a suture eyelet 234 or one or more ribs 236 molded into or attached to the adapter 224 (located at the proximal end of the sheath body 222). This allows an operator to suture and secure the adapter 224 to the patient. In some embodiments, a slidable fastener may be coupled to a portion of the patient (e.g., the skin) to aid in maintaining at least the position and alignment of the sheath body 222 relative to the blood vessel.

[0027] When the access sheath 220 is introduced into a blood vessel, it is desirable for it to be structurally strong (e.g., resistant to kinking or buckling) without traumatizing the blood vessel. For example, some procedures may limit the amount of sheath insertion into the artery or may involve a steep insertion angle. For example, in some cases, the distal end of the sheath body 222 may be directed toward the rear wall of the blood vessel at least during insertion into the blood vessel. This may create a risk of injury from the distal end of the sheath body 222 and / or a device inserted through the sheath body 222. Various embodiments of the access sheath 220 and dilator 260 are described herein that are configured to provide safe, efficient, and effective access to the blood vessel. For example, the various access sheaths 220 and various dilators 260 described herein include one or more of a shorter length and an atraumatic or protective distal end that help prevent undesired damage to the blood vessel, including minimizing dissection during percutaneous vascular access.

[0028] Described below are various embodiments of an access sheath system that can more safely and efficiently provide access to the vascular system, for example, to insert and guide one or more devices along the vascular system to perform various procedures.

[0029] 2A and 2B illustrate an embodiment of an access sheath system 300 for safe and effective vascular navigation and vascular puncture dilation. As shown in FIGS. 2A and 2B, the access sheath system 300 can include an embodiment of an access sheath 320 including a sheath body 322 having a protective distal end 380. The access sheath 320 can be configured to protect against unwanted vascular injury. For example, in some embodiments, the access sheath body 322 can include a length that limits placement of the protective distal end 380 within the blood vessel V.

[0030] As shown in FIG. 2B, in some embodiments, the sheath guide 353 can be positioned along or adjacent to the patient's skin S to maintain and / or control the position of the sheath body 322 relative to the blood vessel V. Additionally, the sheath body 322 can have a length that allows the protective distal end 380 to extend within the blood vessel V without contacting or damaging the opposing blood vessel wall Vw. For example, as shown in FIG. 2B, the sheath body 322 can have a length that allows the protective distal end 380 to extend a first length L1 within the blood vessel V, leaving approximately a second length L2 between the protective distal end 380 of the sheath body 322 and the opposing blood vessel wall Vw. The second distance L2 can provide a space between the protective distal end 380 of the sheath body 322 and the opposing blood vessel wall Vw to prevent damage to the opposing blood vessel wall Vw. In some embodiments, the sheath body 322 can include a length between about 4 centimeters and about 10 centimeters.

[0031] As shown in FIGS. 2A and 2B, the protective distal end 380 of the sheath body 322 can include an atraumatic surface 382 to prevent the access sheath 320 from adversely interacting with the blood vessel V (e.g., puncturing or damaging the opposing vessel wall Vw). For example, the atraumatic surface 382 can be rounded or chamfered to prevent the atraumatic surface 382 from including sharp edges that can easily damage the blood vessel in the event of accidental or undesired contact between the opposing vessel wall Vw and the protective distal end 380. In some embodiments, the protective distal end 380 is made of a flexible and / or compressible material to reduce or prevent damage to the blood vessel in the event of unintentional contact at the protective distal end 380. For example, the protective distal end 380 can be made of one or more of a flexible and / or compressible plastic and a biocompatible material.

[0032] In some embodiments, the access sheath 320 can be guided along an embodiment of the guidewire 215 to position the sheath body 322 including the protective distal tip 380 at a desired location. The access sheath 320 can include an indicator along its exterior surface, for example, to visually indicate the depth to which the sheath body 322 has been inserted into tissue. In some embodiments, blood emerging from an opening in the access sheath 320 can visually indicate that the protective distal tip 380 has been inserted into the vessel V. As shown in FIG. 2A, the sheath body 322 is provided with a sheath inlet 365, which allows blood from the punctured vessel V to pass through the sheath inlet 365 and flow along the lumen 321 of the sheath body 322 toward the proximal end of the sheath body 322 where the user can observe the blood being expelled from the vessel. For example, once a user sees blood being expelled from a vessel, the user can view one or more indicators along the exterior surface of the sheath body 322 to position the protective distal end 380 of the sheath body 322 relative to the vessel. In some embodiments, the sheath inlet 365 is located about 1 to about 3.5 millimeters from the protective distal end 380 of the sheath body 322. By locating the sheath inlet 365 adjacent the protective distal end 380, for example, more precise positioning of the protective distal end 380 relative to the vessel wall Vw can be achieved.

[0033] As shown in FIG. 2A, an embodiment of a dilator 360 can extend through the lumen 361 of the access sheath 320. In some embodiments, the dilator 360 can include a dilator inlet 359, a dilator outlet 363, and an inner passageway 364 extending between the dilator inlet 359 and the dilator outlet 363. For example, when the dilator 360 is positioned within the inner lumen 361 of the access sheath 320, the dilator inlet 359 and the sheath inlet 365 can be aligned, which allows blood to flow from a blood vessel through the aligned dilator inlet 359 and sheath inlet 365 and into the inner passageway 364 of the dilator 360. The blood then flows along the inner passageway 364 of the dilator 360 and exits through the dilator outlet 363. The dilator outlet 363 can be positioned along the dilator cap 371, as shown in FIG. 2A. For example, during use, the dilator cap 371 can be positioned outside the blood vessel and within the user's field of view, such that blood reaching the dilator outlet 363 is visible to the user.

[0034] As shown in FIG. 2A, the sheath body 322 can include at least one arm 370 extending therefrom, which allows, for example, a user to grasp one or more arms 370. The arms 370 can be coupled to the sheath body 322 or can form an extension of the sheath body 322. In one embodiment, the sheath body 322 can be configured to disassemble or separate, which allows the sheath body 322 to be removed with little or no disturbance to the device extending therethrough. For example, a user can grasp the arm 370 and pull it in a direction (e.g., away from the dilator 360 and / or the longitudinal axis of the sheath body 322). This can cause the sheath body 322 to be pulled back and / or peeled away from the dilator 360 and / or the device extending therethrough (e.g., the sheath body 322 separates into multiple portions). For example, the sheath body 322 can be configured to separate into multiple sections by pulling at least one arm 370 at a predetermined angle relative to the longitudinal axis of the sheath body 322. In some embodiments, for example, pulling the arm 370 in a proximal direction (e.g., in a direction approximately parallel to the longitudinal axis of the sheath body 322) can cause the sheath body 322 to retract and remain in place. In some embodiments, the sheath body 322 can be constructed of one or more of a polyethylene material, a polytetrafluoroethylene (PTFE) material, a fluorinated ethylene propylene (FEP) material, and a cross-linked FEP material. In some embodiments, the sheath body 322 can be disassembled or separated in a particular manner and / or formed into multiple sections by cutting into a portion of the sheath body 322 (e.g., an outer surface of the sheath body 322) and / or cross-linking the material of the sheath body 322.

[0035] 2B, the guide sheath 367 can extend through the access sheath 320, thereby providing a protected channel between the access sheath 320 and the treatment site. The guide sheath 367 includes an elongate body having a sheath passageway extending therealong. As described below, some embodiments of the access sheath system 300 can include embodiments of a dilator 360 that can include an atraumatic distal tip and embodiments of a guide sheath 367 that can combine to reduce the device of the access sheath system 300.

[0036] 3A and 3B show an embodiment of a dilator 460 having two portions and including an atraumatic distal tip. As shown in FIG. 3A, the dilator 460 includes an embodiment of a guide sheath 367 including an elongated body 368 and a sheath passageway 469 extending along the guide sheath 367. The dilator 460 also includes an atraumatic tip including a balloon tip element 490 as shown in FIGS. 3A and 3B. For example, the balloon tip element 490 may include an inflatable tapered balloon coupled to a fluid line, which allows the balloon tip element 490 to be inflated to an inflated state and deflated to a deflated state as needed. As shown in FIGS. 3A and 3B, in the inflated state, the balloon tip element 490 may include a distal tapered surface 497 adjacent a distal end 491 of the balloon tip element 490. The distal tapered surface 497 may provide an atraumatic surface to facilitate safe and efficient advancement of the dilator 460 along a blood vessel. Additionally, the balloon tip element 490 includes a proximal engagement feature 492 configured to provide a protective covering over the distal end 470 of the guide sheath 367, thereby preventing damage to the blood vessel from a stiffer guide sheath 367 (e.g., to enable efficient intravascular navigation and positioning).

[0037] As shown in FIG. 3A, the proximal engagement feature 492 of the balloon tip element 490 can include a proximal stepped surface 496 that is oriented at an angle, e.g., a generally perpendicular angle, relative to the longitudinal axis of the dilator 460. The proximal stepped surface 496 can engage and completely or at least partially cover the distal end 470 of the guide sheath 367. This can provide a protective cover over the distal end 470 of the guide sheath 367. The balloon tip element 490 can be made from a variety of materials, including compliant, flexible, and / or resilient materials. This can prevent tissue damage as the balloon tip element 490 is inserted into and moved along the vessel by the dilator 460. In some embodiments, the balloon tip element 490 can expand and then contract during insertion and / or movement of the dilator 460. In some embodiments, the balloon tip element 490 can be deflated and removed, leaving the guide sheath 367 positioned within the blood vessel, without the balloon tip element 490.

[0038] As shown in FIG. 3A, in some embodiments, the balloon tip element 490 can include a proximal section 495 (e.g., an elongated lumen). The proximal section 495 has an elongated shape, and a first diameter along an outer surface of the proximal section 495 is smaller than a second diameter of a distal section of the adjacent balloon tip element 490. The first diameter associated with the proximal section 495 can be sized to allow the proximal section 495 to extend along a sheath passageway or inner passageway 469 of the guide sheath 367 and to provide a slip fit or friction fit therewith. As shown in FIG. 3A, the proximal section 495 can have a length that allows the proximal section 495 to extend along the sheath passageway 469 of the guide sheath 367. This allows the balloon tip element 490 to be positioned and maintained at the distal end of the guide sheath 367 to ensure protection of the distal end 470 of the guide sheath 367 and prevention of damage to the blood vessel.

[0039] All or a portion of the balloon tip element 490 may be inflatable. For example, the proximal section 495 may be inflatable or non-inflatable. In some embodiments, only the portion of the balloon tip element 490 distal to the proximal section 495 is inflatable, and the remaining portion of the balloon tip element 490 (e.g., the proximal section 495) may comprise a more rigid structure, such as an elongated body including a flow passage (e.g., for inflation / deflation) and a dilator passage or internal passage 464 configured for the guidewire 215 to extend along the entire length of the balloon tip 490. In some embodiments, the balloon tip element 490 may have an outer diameter (e.g., adjacent the proximal engagement feature 492) of about 0.103 inches to about 0.108 inches, for example, a 6 French guide sheath 367. In some embodiments, the outer diameter of the balloon tip element 490 may be about 0.124 inches to about 0.128 inches, for example, a 8 French guide sheath 367. For example, the length of the distal portion of the balloon tip element 490 (e.g., the portion distal to the proximal section 495) can vary from about 2 centimeters to about 12 centimeters. Other dimensions of the distal portion of the balloon tip element 490 are within the scope of this disclosure. FIGS. 4A-4C show another embodiment of a dilator 560 for safe and effective insertion into and movement along the vasculature while minimizing the number of parts and minimizing tool changeover within the access sheath 320. As shown in FIG. 4A, the dilator 560 can include a tapered tip element 590 that is movable along a longitudinal axis of the dilator 560 and relative to an embodiment of a guide sheath 367 that may be part of the dilator 560 or separate. As shown in FIG. 4A, the tapered tip element 590 can include a distal tapered surface 597 adjacent a distal end 591 of the tapered tip element 590. As shown in FIG. 4B, the tapered tip element 590 can include a stepped surface 596 that is generally perpendicular to the longitudinal axis of the dilator 560 and configured to engage and protect the distal end 570 of the guide sheath 367.The tapered tip element 590 can include a proximal tapered region 595 that can slidably engage a portion of the guide sheath 367 along the sheath passage or inner passage 469 of the guide sheath 367. In some embodiments, the portion of the sheath passage 469 can include a tapered or angled surface 571 that can slidably engage the proximal tapered region 595 of the tapered tip element 590, for example, when the dilator 560 transitions between the first and second positions, as shown in Figures 4A and 4B, respectively.

[0040] For example, as shown in Figure 4A, in a first position, the stepped surface 596 of the tapered tip element 590 may engage the distal end 570 of the guide sheath 367 to prevent damage to the blood vessel, for example, when inserted into and moved along the blood vessel. In a second position, as shown in Figures 4B and 4C, the stepped surface 596 of the tapered tip element 590 is positioned away from the distal end 570 of the guide sheath 367. For example, the dilator 560 may form the second position when the dilator 560 is inserted into the guide sheath 367, when the dilator 560 is removed from the guide sheath 367, and / or when tracking the guide sheath 367 along a proximal portion of the dilator 560. 4C , the guide sheath 367 includes an elongate body 368 having a sheath passage 469, which may be, for example, an elongate tubular element extending proximally adjacent a proximal tapered region 595, a proximal portion of a tapered tip element 590 may slidably engage and extend along the sheath passage 469. The tapered tip element 590 may include a dilator passage 564, which allows the guidewire 215 to extend, for example, along the elongate tubular element and through the dilator 560.

[0041] For example, during use, a proximal portion of tapered tip element 590 (e.g., a proximal end of an elongated portion of tapered tip element 590 extending along sheath passage 469 of guide sheath 367) can be advanced distally relative to guide sheath 367 to advance stepped surface 596 of tapered tip element 590 away from guide sheath 367, e.g., from a first position (FIG. 4A) to a second position (FIG. 4B). In some embodiments, the proximal portion of tapered tip element 590 can be manipulated by a user, e.g., to advance tapered tip element 590. Further, during use, the proximal portion of the tapered tip element 590 can be advanced proximally relative to the guide sheath 367, such as to advance the stepped surface 598 of the tapered tip element 590 toward and / or against the guide sheath 367 (e.g., to at least partially cover the distal end of the guide sheath 367), e.g., from the second position (FIG. 4B) to the first position (FIG. 4A).

[0042] 5A and 5B show another embodiment of a dilator 660 that allows for safe and effective insertion into and movement along a blood vessel. As shown in FIG. 5A, the dilator 660 can include a flexible tapered tip element 690 that is movable along a longitudinal axis of the dilator 660 relative to an embodiment of a guide sheath 367 that may be part of the dilator 660 or may be separate from the dilator 660. As shown in FIG. 5A, the flexible tapered tip element 690 can include a distal tapered surface 697 adjacent a distal end 691 of the flexible tapered tip element 690. As shown in FIG. 5A and 5B, the flexible tapered tip element 690 can include a flexible extension 698 that includes a distal surface 696. The distal surface 696 is generally perpendicular to the longitudinal axis of the dilator 560 and can be configured to engage and protect the distal end 570 of the guide sheath 367, such as when the dilator 660 is in a first position as shown in FIG. 5A. As shown in Figures 5A and 5B, the flexible tapered tip element 690 can slidably engage a distal portion of the guide sheath 367, for example, when the dilator 660 transitions between the first position and the second position.

[0043] For example, in a first position (FIG. 5A), the stepped surface 696 of the flexible tapered tip element 690 can engage the distal end 670 of the guide sheath 367 to prevent damage to the blood vessel, for example, when inserted into and moved along the blood vessel. As shown in FIG. 5B, in a second position, the flexible extension 698 can expand radially over the distal end 670 of the guide sheath 367 and contract proximally. For example, the dilator 660 can form the second position when tracking the guide sheath 367 over a proximal portion of the dilator 660. As shown in FIG. 5A, some embodiments of the guide sheath 367 can include a distal extension 680 that can provide support along an inner wall of the flexible extension 698 when the dilator 660 is in the first position to limit retraction of the flexible tapered tip element 690 relative to the guide sheath 367. 5B, the guide sheath 367 includes an elongate body 368 having a sheath passage 469, which may be, for example, an elongate tubular element extending proximally adjacent a proximal tapered region 595, and a proximal portion of a tapered tip element 690 may slidably engage and extend along the sheath passage 469. The tapered tip element 690 may include a dilator passage 664, which allows the guidewire 215 to extend, for example, along the elongate tubular element and through the dilator 660.

[0044] For example, during use, a proximal portion of the tapered tip element 690 (e.g., a proximal end of the elongated portion of the tapered tip element 690 extending along the sheath passage 469 of the guide sheath 367) can be advanced distally relative to the guide sheath 367. Such distal advancement, e.g., from the second position (FIG. 5B) to the first position (FIG. 5A), advances the stepped surface 696 of the tapered tip element 690 so that it is positioned generally parallel to the distal end 670 of the guide sheath 367. In some embodiments, the proximal portion of the tapered tip element 690 (e.g., the elongated lumen) can be manipulated by a user, e.g., to advance the tapered tip element 690. Further, during use, the proximal portion of the tapered tip element 690 can be advanced proximally relative to the guide sheath 367, causing the flexible extension 698 of the tapered tip element 690 to advance radially outwardly toward and / or from the guide sheath 367, e.g., from a first position (FIG. 5A) to a second position (FIG. 5B). For example, as shown in FIG. 5B, when the dilator is in the second position, the flexible extension 698 can engage against and / or extend along an outer surface of the guide sheath 367. In such a configuration, the flexible extension can completely or at least partially cover the distal end of the guide sheath 367.

[0045] Any or all of the devices described above may be provided to a user in the form of a kit, such that one or more of the components of the system are included in a common package or collection of packages. An embodiment of an access sheath kit includes one or more of an access sheath, a dilator, and a guidewire, all configured for vascular access, as described above.

[0046] Although the specification contains many specifics, these should not be construed as limiting the scope of the claimed invention or what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described in the context of separate embodiments herein may also be implemented in combination in one embodiment. Conversely, various features described in the context of one embodiment may also be implemented in multiple embodiments individually or in any suitable subcombination. Furthermore, even if features are described above as functioning in a certain combination and originally claimed as such, one or more features of the claimed combination may be deleted from the combination, and the claimed combination may be derived into a subcombination or variation of the subcombination. Similarly, although operations are shown in the figures in a certain order, it should not be understood that such operations must be performed in the particular order or sequential order shown, or that all of the operations shown must be performed, in order to achieve desirable results.

[0047] Although various method and device embodiments are described in detail herein with reference to certain versions, it should be understood that other versions, embodiments, methods of use, and combinations thereof are possible, and therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

1. It includes an access sheath and an expander, The aforementioned access sheath is A long, slender sheath body designed in size and shape to be inserted into an artery, A protective distal end having a non-traumatic surface, Equipped with, The aforementioned elongated sheath body includes a lumen extending between the proximal sheath end and the distal sheath end. The aforementioned expander comprises a non-traumatic tip and a guide sheath. The non-traumatic tip has a proximal portion and a distal portion. The proximal portion of the non-traumatic tip is formed to extend along the sheath passage of the guide sheath, The distal portion of the non-traumatic tip has a distal tapered surface, The non-traumatic tip engages with the distal end of the guide sheath and is formed to cover at least a portion of the distal end of the guide sheath, thereby protecting the artery from the distal end of the guide sheath. Access sheath system.

2. The device further comprises a guidewire sized to extend along the dilator passage of at least the non-traumatic tip, The access sheath system according to claim 1.

3. The non-traumatic tip of the expander includes an inflatable balloon tip element, The access sheath system according to claim 1.

4. The inflatable balloon tip element includes a proximal stepped surface, The proximal stepped surface is formed to engage with the distal end of the guide sheath and cover the distal end of the guide sheath when the inflatable balloon is inflated. The access sheath system according to claim 3.

5. The inflatable balloon tip element includes a proximal section having a first outer diameter and a distal section having a second outer diameter. The first outer diameter is smaller than the second outer diameter, and the proximal section is formed to be coupled to the sheath passage. The access sheath system according to claim 3.

6. The non-traumatic tip is movable relative to the guide sheath along the longitudinal axis of the guide sheath so as to form a first position and a second position of the dilator. The access sheath system according to claim 1.

7. At the first position, The proximal surface of the non-traumatic tip engages with the distal end of the guide sheath and at least partially covers the distal end of the guide sheath. The access sheath system according to claim 6.

8. The aforementioned proximal surface is a part of the proximal stepped surface of the non-traumatic tip, The aforementioned proximal stepped surface is located proximal to the tapered surface. The access sheath system according to claim 7.

9. When the expander is in the second position, the proximal stepped surface is positioned away from the distal end of the guide sheath. The access sheath system according to claim 8.

10. At the second position, The flexible extension of the non-traumatic tip is radially extended and positioned along the outer surface of the distal end of the guide sheath, The access sheath system according to claim 6.

11. The sheath body of the access sheath includes at least one arm, At least one of the arms is configured to separate the sheath body into multiple parts when pulled away from the longitudinal axis of the sheath body. The access sheath system according to claim 1.

12. Adjacent to the distal end, the access sheath includes a first region having a first outer diameter and a second region located proximal to the first region and having a second outer diameter larger than the first outer diameter. The access sheath system according to claim 1.

13. The non-traumatic tip includes a flexible extension configured to extend along the first region, The access sheath system according to claim 12.

14. The access sheath includes a shoulder region between the first region and the second region. The access sheath system according to claim 13.

15. The flexible extension is configured to transition from a position in which the flexible extension is positioned along the first region to a second configuration in which the flexible extension covers the shoulder region. The access sheath system according to claim 14.

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