Telescopic vascular sheath systems and methods

Abstract

Various embodiments of telescopic vascular sheaths and related methods are disclosed. The telescopic vascular sheath may include a plurality of sheath sections each having a tapered distal section and a proximal section. Each tapered distal section may include a distal open surface, and each proximal section may include a proximal outer surface. Each sheath segment of the plurality of sheath segments is slidably engageable with at least one adjacent sheath segment along one or more of the distal open surface and the proximal outer surface. The telescopic vessel sheath may also include a working passage extending through the plurality of sheath segments and along a longitudinal axis of the telescopic vessel sheath. The working pathway may provide access to a lumen of a blood vessel. In some embodiments, a blood flow system is disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Pursuant to 35 U.S.C. §119(e), this application claims priority to U.S. Provisional Patent Application Serial Nos. 63 / 346,265, filed on May 26, 2022, entitled “TELESCOPIC VASCULAR SHEATH,” and 63 / 482,881, filed on February 2, 2023, entitled “TELESCOPIC VASCULAR SHEATH,” the entire contents of which are incorporated herein by reference. Background Art

[0003] Various medical procedures involve access to the lumen of a blood vessel. A sheath or catheter can provide a conduit from an extracorporeal space to the interior of the body. These devices can be used to insert tools or provide treatments through various entry sites (e.g., surgical, percutaneous, or existing body orifices) during various procedures. Generally, it is desirable to create the smallest possible entry channel that is appropriate for a given treatment, when compared to a larger entry site, to reduce wound healing time and infection risk, speed recovery, and improve patient outcomes and comfort.

[0004] For example, mechanical thrombectomy can be an important tool in treating stroke. Mechanical thrombectomy can include the use of an aspiration catheter, a stent retriever, or a combination of both. To perform these treatments, a physician may use successively larger sheaths to access the vascular system until the desired size is reached to accommodate and support the selected mechanical thrombectomy treatment. Exchanging a sheath for one with the appropriate size may create a risk of losing access at the intended entry site, may be time consuming, and increase the cost of treatment. Therefore, methods and devices are needed to reduce or prevent such consequences resulting from exchanging sheaths. Summary of the invention

[0005] Aspects of the present subject matter include an embodiment of a telescopic vascular sheath for insertion into a blood vessel. In one aspect, the telescopic vascular sheath may include a plurality of sheath segments, each having a tapered distal segment and a proximal segment. Each tapered distal segment may include a distal opening surface, and each proximal segment may include a proximal outer surface. Additionally, each of the plurality of sheath segments may be slidably engaged with at least one adjacent sheath segment along one or more of the distal opening surface and the proximal outer surface. The telescopic vascular sheath may also include a working passage extending through the plurality of sheath segments and along the longitudinal axis of the telescopic vascular sheath. The working passage may provide access to the lumen of the blood vessel.

[0006] In some variations, one or more of the following features may be optionally included in any feasible combination. For example, each of the plurality of sheath segments may be independently movable along the longitudinal axis. The proximal segment may include a tubular shape extending a distance along the longitudinal axis. The tapered distal segment may include a distal opening defined by a distal opening surface. The distal opening surface may be approximately linear and parallel to the longitudinal axis. The distal opening surface may be approximately linear and parallel to the longitudinal axis. The working passage may be defined by a first sheath segment of the plurality of sheath segments, and the distal opening surface of the first sheath segment may have a smaller diameter than the distal opening surface associated with each of the other sheath segments of the plurality of sheath segments.

[0007] In some embodiments, the distal opening surface of the second sheath segment of the plurality of sheath segments may form a sliding fit along the proximal segment of the first sheath segment. The tapered distal segment may provide atraumatic insertion of the telescopic vascular sheath into tissue and the lumen of a blood vessel. The total length of each sheath segment of the plurality of sheath segments is about 5 cm to about 200 cm. The diameter of the distal opening is about 0.01 inches to about 20F. The telescopic vascular sheath may include a first sheath positioned proximal to the longitudinal axis of the telescopic vascular sheath. The first sheath may include a proximal segment having a smaller diameter and a greater total length than the other sheath segments of the telescopic vascular sheath.

[0008] In some embodiments, the telescopic vascular sheath may include an outer sheath segment of a plurality of sheath segments positioned at a position farthest from the longitudinal axis of the telescopic vascular sheath. The outer sheath segment may include a first proximal segment having a larger diameter and a shorter length than the proximal segment associated with each of the other sheath segments of the plurality of sheath segments. The telescopic vascular sheath may also include a valve positioned at the proximal end of at least one sheath segment of the plurality of sheath segments. The telescopic vascular sheath may also include a port positioned at the proximal end of at least one sheath segment of the plurality of sheath segments. The port may include a fluid path in fluid communication with the working passage. The telescopic vascular sheath may include at least one sheath segment of the plurality of sheath segments having an inflatable balloon. When in an inflated state, the inflatable balloon may expand radially outward from the proximal segment. At least one sheath segment of the plurality of sheath segments may provide a trauma-resistant expansion of tissue and a trauma-resistant expansion into a blood vessel.

[0009] In another related aspect of the current subject matter, a method for a telescopic vascular sheath includes advancing a first sheath segment of a plurality of sheath segments of a telescopic vascular sheath into the lumen of a blood vessel. The method may also include advancing a second sheath segment of a plurality of sheath segments of a telescopic vascular sheath into the lumen of a blood vessel. The telescopic vascular sheath may include a plurality of sheath segments, each of which has a tapered distal segment and a proximal segment. Each tapered distal segment may include a distal opening surface, and each proximal segment may include a proximal outer surface. Additionally, each of the plurality of sheath segments may be slidably engaged with at least one adjacent sheath segment along one or more of the distal opening surface and the proximal outer surface. The telescopic vascular sheath may also include a working passage extending through the plurality of sheath segments and along the longitudinal axis of the telescopic vascular sheath. The working passage may provide access to the lumen of the blood vessel. The method may also include slidably translating the first sheath segment relative to the second sheath segment.

[0010] In some variations of the method, one or more of the following features may optionally be included in any feasible combination. For example, each of the plurality of sheath segments may be independently movable along the longitudinal axis. The proximal segment may include a tubular shape extending a distance along the longitudinal axis. The tapered distal segment may include a distal opening defined by a distal opening surface. The distal opening surface may be approximately linear and parallel to the longitudinal axis. The distal opening surface may be approximately linear and parallel to the longitudinal axis. The working passage may be defined by a first sheath segment of the plurality of sheath segments, and the distal opening surface of the first sheath segment may have a smaller diameter than the distal opening surface associated with each of the other sheath segments of the plurality of sheath segments.

[0011] In some embodiments, the distal opening surface of the second sheath segment of the plurality of sheath segments may form a sliding fit along the proximal segment of the first sheath segment. The tapered distal segment may provide atraumatic insertion of the telescopic vascular sheath into tissue and the lumen of a blood vessel. The total length of each sheath segment of the plurality of sheath segments is about 5 cm to about 200 cm. The diameter of the distal opening is about 0.01 inches to about 20F. The telescopic vascular sheath may include a first sheath positioned proximal to the longitudinal axis of the telescopic vascular sheath. The first sheath may include a proximal segment having a smaller diameter and a greater total length than the other sheath segments of the telescopic vascular sheath.

[0012] In some embodiments, the telescopic vascular sheath may include an outer sheath segment of a plurality of sheath segments positioned at a position farthest from the longitudinal axis of the telescopic vascular sheath. The outer sheath segment may include a first proximal segment having a larger diameter and a shorter length than the proximal segment associated with each of the other sheath segments of the plurality of sheath segments. The telescopic vascular sheath may also include a valve positioned at the proximal end of at least one sheath segment of the plurality of sheath segments. The telescopic vascular sheath may also include a port positioned at the proximal end of at least one sheath segment of the plurality of sheath segments. The port may include a fluid path in fluid communication with the working passage. The telescopic vascular sheath may include at least one sheath segment of the plurality of sheath segments having an inflatable balloon. When in an inflated state, the inflatable balloon may expand radially outward from the proximal segment. At least one sheath segment of the plurality of sheath segments may provide a trauma-resistant expansion of tissue and a trauma-resistant expansion into a blood vessel.

[0013] In another aspect, a blood flow system is disclosed that includes a first arterial access device for accessing a first artery; a second arterial access device for accessing a second artery; and an arterial return device for communicating with a third artery. The arterial return device can be in fluid communication with the first arterial access device and the second arterial access device.

[0014] In some variations, one or more of the following features may optionally be included in any feasible combination. For example, one or more of the first arterial access device, the second arterial access device, and the arterial return device may include a telescoping vascular sheath. In some embodiments, the blood flow system may further include a shunt that directs fluid flow from the arterial return device to both the first arterial access device and the second arterial access device. In some embodiments, the blood flow system may further include a flow control element that controls the flow rate between the arterial return device and the shunt.

[0015] The 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A partially exploded side view of an embodiment of an access device including a sheath for providing access to a lumen of a blood vessel is shown.

[0017] Figure 2 Shown including sheath stop Figure 1 Partial side view of the entry device in.

[0018] Figure 3 Showing that the blood vessel is entering the lumen Figure 1 Example of an entry device in .

[0019] Figure 4AA side view of an embodiment of a telescoping vascular sheath comprising multiple sheath segments is shown.

[0020] Figure 4B Show Figure 4A Side cross-sectional view of the telescopic vascular sheath.

[0021] Figure 4C Show Figure 4A A side cross-sectional view of an embodiment of one of multiple sheath segments of a telescoping vascular sheath.

[0022] Figure 4D Showing that the blood vessel is entering the lumen Figure 4A Example of a retractable vascular sheath in .

[0023] Figure 4E Shown is a method comprising an inflatable balloon Figure 4A A side cross-sectional view of another embodiment of one of the multiple sheath segments of a telescoping vascular sheath.

[0024] Figure 5 is a schematic illustration of a blood flow system including at least one arterial access device into the left common carotid artery and at least one arterial access device into the right common carotid artery via a transcervical approach, and an arterial return device communicating with an artery, such as a femoral artery.

[0025] In practice, similar reference numerals represent similar structures, features or elements. DETAILED DESCRIPTION

[0026] The disclosed methods, devices, and systems are directed to various embodiments of telescopic vascular sheaths that can effectively and efficiently create access to the lumen of a blood vessel, and form a working passage through tissue and into the lumen, such as for performing various surgeries. The telescopic vascular sheaths described herein may include multiple sheath segments that can move independently relative to each other to allow the telescopic vascular sheath to form various morphologies. For example, each sheath segment may have different sizes (e.g., outer and inner diameters, lengths, etc.), thereby allowing various morphologies of the telescopic vascular sheath by positioning each sheath segment at different positions relative to each other and including and removing one or more sheath segments. Therefore, the embodiments of the telescopic vascular sheaths described herein can be configured to create access through tissue and into the lumen of a blood vessel, and form a working passage through tissue and / or into a blood vessel, which is sized to perform the desired surgery. For example, in some embodiments, at least one sheath segment (e.g., the sheath segment with the largest diameter) can be sized to provide expansion through tissue rather than insertion into a blood vessel. Such customized sizing of the telescopic vascular sheath can reduce wound healing time and infection risk, speed recovery, and improve patient outcomes and comfort.

[0027] The telescopic vascular sheath can also allow for effective changes in form during surgery, such as switching from a smaller diameter sheath segment positioned at the distal end of the telescopic vascular sheath to a larger diameter sheath segment. For example, a user may want to position the smaller diameter sheath segment at the distal end during insertion of the telescopic vascular sheath into a blood vessel. Additionally, once the blood vessel is entered through at least the smaller diameter sheath segment, the user may want to increase the working passage through the telescopic vascular sheath to insert one or more devices through the working passage into the lumen of the blood vessel. This conversion to a larger working passage can be effectively achieved with the telescopic vascular sheath without retracting the telescopic vascular sheath from the lumen of the blood vessel.

[0028] For example, the sheath segment with a smaller diameter can slide in the proximal direction to allow the sheath segment with a larger diameter to be positioned at the distal end. Additionally, the sheath segment with a smaller diameter can be removed and separated from the remaining sheath segments that are slidably coupled together to form a working passage. In the case of removing and separating the sheath with a smaller diameter, the working passage can have a larger diameter (e.g., the inner diameter of the smallest remaining sheath segment). Therefore, the telescopic vascular sheath can avoid the need for multiple sheath exchanges, thereby reducing the risk of losing access to the vascular lumen (which may require re-piercing or re-entering the lumen), as well as speeding up treatment time and reducing surgical costs.

[0029] In some embodiments, the telescopic vascular sheath may include multiple sheath segments that may be sized to facilitate performing a variety of procedures, including cardiovascular, neurovascular, ophthalmic, gastrointestinal, and urological procedures. Thus, the telescopic vascular sheath may be used with a variety of vascular systems, including the common femoral vein, subclavian vein, carotid artery, jugular vein, inferior vena cava, etc., without departing from the scope of the present invention. In addition, the telescopic vascular sheath may be used with a variety of access systems, including one or more of the exemplary access systems described herein.

[0030] In some embodiments, a blood flow system is described. The blood flow system may include a first arterial access device that enters a first blood vessel (e.g., the left common carotid artery) and a second arterial access device that enters a second blood vessel (e.g., the right common carotid artery), such as via a transcervical approach. Additionally, the blood flow system may include an arterial return device that is in communication with an artery, such as a femoral artery. The arterial return device may be in fluid communication with the first arterial access device and the second arterial access device. In some embodiments, any one or more of the first arterial access device, the second arterial access device, and the arterial return device may include an embodiment of a telescopic vascular sheath described herein.

[0031] Figure 1An exemplary embodiment of an access system 110 is shown, which includes a distal sheath 605, a proximal extension 610, a flow line 615, an adapter or Y-connector 620, and a hemostasis valve 625. The access system 110 may also include a dilator 645 having a tapered tip 650, and an introducer guidewire 611. The access system 110, along with the dilator 645 and the introducer guidewire 611, may be used together to gain access to a blood vessel. The features of the access system may be optimized to access various blood vessels, such as via transfemoral and transcarotid approaches.

[0032] The distal sheath 605 may be adapted to be introduced through an incision or puncture in the wall of a blood vessel (e.g., femoral artery, common carotid artery, etc.), which may be an open surgical incision or a percutaneous puncture established, for example, using the Seldinger technique. Figure 1 As shown, the proximal extension 610 including an elongated body can have a lumen that is continuous with the lumen of the sheath 605. The two lumens can be joined by a Y-connector 620, which also connects the lumen of the flow line 615 to the sheath. For example, the flow line 615 can be connected to a retrograde shunt and form a first leg thereof.

[0033] The flushing line 635 can be connected to the side of the hemostatic valve 625 and can have a stopcock 640 at its proximal or distal end. The flushing line 635 can allow for the introduction of saline, contrast fluid, etc. during surgery. The flushing line 635 can also allow for pressure monitoring during surgery. For example, a dilator 645 with a tapered distal end 650 can be provided to facilitate the introduction of the distal sheath 605 into a blood vessel. The dilator 645 can be introduced through the hemostatic valve 625 so that the tapered distal end 650 extends through the distal end of the sheath 605, such as Figure 2 The dilator 645 may have a central lumen to accommodate a guidewire. Typically, the guidewire is first placed into the vessel and the dilator / sheath combination is advanced over the guidewire as it is introduced into the vessel. Optionally, a sheath stopper 705, such as in the form of a tube, may be provided that is coaxially received on the exterior of the distal sheath 605, also as shown. Figure 2 shown.

[0034] The access system 110 can provide access to a vascular lumen, such as for performing at least a portion of any number of a variety of procedures. For example, during a transcarotid revascularization (TCAR) procedure, an arterial sheath 605 can be inserted into a patient's common carotid artery (CCA). To achieve retrograde flow of blood, the CCA can be occluded to prevent antegrade blood flow from the aorta through the CCA. Flow through the CCA can be occluded with an external vascular ring or tape, a vascular clamp, an internal occlusive member, such as a balloon or other type of closure device. During a procedure using the access system 110, one or more of a variety of blood flow controls can be used.

[0035] Figure 3 An embodiment of an access system 110 is shown, which includes an embodiment of a sheath 605 inserted into a blood vessel V, such as a carotid artery, exposed through an incision I. For example, a sheath stopper 705 can be used with the sheath 605 to help guide and position the sheath 605 within the blood vessel, such as Figure 3 As shown. The sheath guidewire 611 and the dilator 645 can extend from the distal opening of the sheath 605. For example, manual occlusion of the blood vessel V performed at an occlusion position located proximal to the distal end of the sheath 605 can be provided by a clinician from the outside of the blood vessel V using a vascular clamp 800, such as a Rummel tourniquet or a vascular ring positioned proximal to the sheath insertion site. The occlusion of the blood vessel can form a closed segment of the blood vessel, preventing blood from flowing along the closed segment. Once the target blood vessel V is processed by the operator, the vascular clamp 800 can be released, allowing the restoration of antegrade blood flow. During surgery, one or more of a variety of methods can be used to occlude the blood vessel without departing from the scope of the present invention.

[0036] Various embodiments of telescoping vascular sheaths that can be used with a variety of access systems, including the access system 110 described herein, are described in detail below. As will be described in more detail below, the telescoping vascular sheaths described herein can be configured to form a variety of different sizes, such as to form an appropriate working path for performing a desired procedure, thereby reducing wound healing time and infection risk, speeding up recovery, and improving patient outcomes and comfort. Additionally, the telescoping vascular sheaths described herein can avoid the need for multiple sheath exchanges, thereby reducing the risk of losing access to the vessel lumen (which may require re-puncture or re-entering the lumen), as well as speeding up treatment time and reducing surgical costs.

[0037] 4A to 4D An embodiment of a retractable vascular sheath 905 is shown that is configured to be partially inserted into tissue and / or vascular system to assist in forming a working passage 906, such as into the lumen of a blood vessel. Figure 4A As shown, the telescopic vascular sheath 905 may include a plurality of concentric sheath segments 910 that are slidably coupled together so that they can move independently relative to each other. The telescopic vascular sheath 905 may include two or more sheath segments 910, such as a first sheath segment 910a, a second sheath segment 910b, a third sheath segment 910c, a fourth sheath segment 901d, and a fifth sheath segment 901e, as shown in FIG. Figure 4A and Figure 4B During use, any one or more of the sheath segments 910 can be used to assist in performing a procedure, such as two or more adjacent sheath segments 910. Each sheath segment 910 can slidably engage at least one adjacent sheath segment 910 in the telescopic vascular sheath 905 and translate along the longitudinal axis L of the telescopic vascular sheath 905, such as Figure 4BAdditionally, each sheath segment 910 can independently translate along the longitudinal axis L relative to one or more other sheath segments 910 of the telescoping vascular sheath 905 .

[0038] like Figure 4C As shown, each sheath segment 910 (e.g., sheath segments 910a, 910b, 910c, 910d, and 910e) may include a proximal segment 912 and a tapered distal segment 914 extending from the distal end of the proximal segment 912. Additionally, each sheath segment 910 may include a sheath segment passage 915 or through-hole extending between a proximal opening 917 at a proximal end 916 of each sheath segment 910 and a distal opening 925 at a distal end 918. Figure 4C As shown, the proximal segment 912 may include a tubular shape extending approximately linearly along the longitudinal axis Ls of the sheath segment 910. The proximal segment 912 may include a proximal outer surface 920 and a proximal inner surface 922. The proximal inner surface 922 may define a proximal portion of the sheath segment passage 915, which may be tubular in shape. The tapered distal segment 914 may include a tapered wall 924 extending at an angle between the distal end of the proximal segment 912 and a distal opening 925. The tapered distal segment 914 may include a distal outer surface 926 and a distal inner surface 928 extending along opposite sides of the tapered wall 924. The distal inner surface 928 may define at least a portion of the distal portion of the sheath segment passage 915. The distal end of the tapered wall 924 may include a distal opening surface 930, which defines the distal opening 925. The distal opening 925 may also define a portion of the sheath segment passage 915.

[0039] like Figure 4C As shown, the distal opening surface 930 can be approximately linear and parallel to the longitudinal axis of the sheath 910. The distal opening surface 930 can be sized to allow the distal opening surface 930 to have a sliding fit along the proximal outer surface 920 of the smaller sheath segment 910. For example, the first sheath segment 910a can be smaller and extend along the sheath segment passage 915 of the second sheath segment 910b, as shown in FIG. Figure 4A and Figure 4B As shown. The distal opening surface 930 of the second sheath segment 910b can have a sliding fit with the proximal segment 912 of the first sheath segment 910a. This can allow two adjacent sheath segments 910 (e.g., the first sheath segment 910a and the second sheath segment 910b) to independently and slidably translate relative to each other. For example, the first sheath segment 910a can be slidingly translated along the longitudinal axis L to form a desired length between the distal ends 918 or distal openings 925 of the first sheath segment 910a and the second sheath segment 910b.

[0040] The telescopic vascular sheath 905 may include any number of sheath segments 910, each of which has a variety of shapes and sizes. For example, each sheath segment 910 may have a different size, such as to allow a slidable connection between the sheath segments 910. In some embodiments, at least some of the sheath segments 910 may provide specific functions, such as performing expansion, performing suction, serving as an introducer, etc. Additionally, one or more sheath segments 910 may provide more than one function, such as changing functions based on surgical steps. For example, the sheath segment 910 may provide support for the microcatheter during tracking, and may also be used as an aspiration catheter, such as once the target anatomical structure has been reached and the smaller sheath segment has been removed / separated from the telescopic vascular sheath 905.

[0041] In some embodiments, the smallest sheath segment (e.g., the first sheath segment 901a) may have the smallest proximal outer surface diameter, which may have a sliding fit with the distal opening surface 930 of the adjacent sheath segment (e.g., the second sheath segment 910b). Thus, the second sheath segment 910b may slideably translate along the proximal outer surface 920 of the first sheath segment 910a so as to allow the first sheath segment 910a to be advanced distally or proximally relative to the second sheath segment 910b. Similarly, the diameter of the distal opening surface 930 or distal opening 925 of the third sheath segment 910c may be sized to form a sliding fit with the proximal outer surface 920 of the second sheath segment 910b, such as to allow the second sheath segment 910b to be advanced distally or proximally relative to the third sheath segment 910c and / or the first sheath segment 910a. The telescopic vascular sheath 905 may include any number of sheath segments 910 that may be slidably coupled together to form telescopic vascular sheaths of various lengths and diameters, such as for performing various procedures.

[0042] In some embodiments, the total length of each sheath segment 910 may increase as the diameter of the proximal outer surface 920 decreases, such as Figure 4A and Figure 4B As shown. For example, the total length of the first sheath segment 910a (e.g., from the proximal end 916 to the distal end 918) can be about 80 centimeters (cm) to about 200 cm, the total length of the second sheath segment 910b can be about 75 cm to about 120 cm, the total length of the third sheath segment 910c can be about 65 cm to about 85 cm, the total length of the fourth sheath segment 910d can be about 25 cm to about 45 cm, and the total length of the fifth sheath segment 910e can be about 5 cm to about 30 cm. The total length of the sheath segments 910 can vary without departing from the scope of the present invention. For example, the telescopic vascular sheath 905 and / or the sheath segments 910 can include a shorter length than the examples provided herein, such as for use with carotid artery access.

[0043] In some embodiments, the diameter of the distal opening 925 is about 0.010 inches (in) to about 10 French (F). For example, the diameter of the distal opening 925 of the first sheath segment 910a may be about 0.010 inches to about 0.025 inches, the diameter of the distal opening 925 of the second sheath segment 910b may be about 3F to about 5F, the diameter of the distal opening 925 of the third sheath segment 910c may be about 0.05 inches to about 0.08 inches, the diameter of the distal opening 925 of the fourth sheath segment 910d may be about 0.08 inches to about 0.1 inches, and the diameter of the distal opening 925 of the fifth sheath segment 910e may be about 7F to about 10F. Other diameters of the distal opening 925 are within the scope of the present invention, such as about 20F.

[0044] like Figure 4B As shown in , the sheath segment 910 (e.g., the first sheath segment 910a) positioned closest to the longitudinal axis L of the telescopic vascular sheath 905 may include a sheath segment passage 915 with the smallest diameter, which has a smaller segment passage diameter than the segment passage diameters of the other sheath segments 910 of the telescopic vascular sheath 905. In addition, since the first sheath segment 910a is positioned closest to the longitudinal axis L (e.g., no other sheath segments 910 are within the first sheath segment 910a), the sheath segment passage 915 of the first sheath segment 910a may define the working passage 906 of the telescopic vascular sheath 905.

[0045] For example, the working passage 906 can provide a safe and effective passage for inserting and / or removing one or more of devices and materials, respectively, into and / or from the vascular system. The telescopic vascular sheath 905 is modular and adjustable such that a first sheath segment 910a (e.g., the sheath segment 910 closest to the longitudinal axis L of the telescopic vascular sheath 905) can be any of a plurality of concentric sheath segments 910, thereby allowing the telescopic vascular sheath 905 to be customized to have a working passage 906 of a size suitable for the procedure.

[0046] like Figure 4B and Figure 4CAs shown, the proximal end 916 of at least one of the sheath segments 910 may include a port 950 having a fluid passage 952 extending therethrough and in fluid communication with the segment passage 915. The fluid passage 952 may allow passage of fluid into and / or out of one or more of the sheath segment passage 915 and / or the working passage 906. The port 950 may extend from a side of the sheath segment 910 and the telescoping vascular sheath 905. The port 950 and / or other proximal features of each sheath segment 910 may also provide a stop or limit to the travel of at least one adjacent sheath segment 910, such as to prevent the proximal end 916 of a smaller diameter sheath segment 910 from falling into the sheath segment passage 915 of a larger diameter sheath segment 910. The port 950 may allow for administration of fluids (e.g., saline, contrast media, drugs, etc.) to the lumen and / or removal of fluids and / or tissues (e.g., blood, thrombus) from the lumen of the vessel.

[0047] In some embodiments, the telescopic vascular sheath may include a valve 960 positioned at the proximal end 916 of one or more sheath segments 910. For example, the valve 960 may include one or more of a hemostatic valve, a rotary hemostatic valve (RHV), a Tuohy Borst valve, a Luer lock, and / or other similar valves. For example, the valve 960 may be permanent, removable, and / or replaceable. In some embodiments, the valve 960 of one sheath segment 910 (e.g., the first sheath segment 910a) may be locked with the valve 960 of an adjacent sheath segment 910 (e.g., the second sheath segment 910b). Such locking may allow at least two sheath segments 910 of the telescopic vascular sheath 905 to be locked together and moved as a single unit. In some embodiments, the valve 960 may enable the introduction, advancement, retraction, or removal of a smaller sheath segment 910. For example, the valve 960 may be locked to an adjacent sheath segment 910 to fix relative motion (axial, longitudinal). In some embodiments, one or more valves 960 may include an eyelet that allows suturing to the patient's skin or other items.

[0048] In some embodiments, one or more sheath segments 910 may be made of a material that allows the sheath segments 910 to be observed under radiography and / or ultrasound. In some embodiments, one or more sheath segments 910 may include radiopaque markings (e.g., radiopaque bands) that can be observed under radiography. In some embodiments, the sheath segments 910 may each have a slight radiopaqueness, which may allow the telescopic vascular sheath 905 to gradually become more visible as more sheath segments 910 are concentrically connected. In some embodiments, one or more sheath segments 910 may include scored echogenic cavitation to enhance visibility under ultrasound. In some embodiments, one or more sheath segments 910 may include depth markings to allow a user to monitor the advancement of the telescopic vascular sheath into tissue and / or a vessel. In some embodiments, one or more sheath segments 910 may include balloons or other support features that provide vascular occlusion and / or achieve flow reversal.

[0049] Figure 4E One embodiment of a sheath segment 1010 is shown that includes an inflatable balloon 1011 positioned adjacent to the distal end 918. For example, once the distal end 918 is in a desired position within a blood vessel, the balloon 1011 can be inflated, such as to provide vascular occlusion. For example, the balloon 1011 can be expanded circumferentially or non-circumferentially around and / or relative to the proximal segment of the corresponding sheath segment 1010 at one or more locations along the length of the sheath segment 1010. Thus, while the balloon 1011 is located within the vessel, the balloon 1011 can be expanded circumferentially or non-circumferentially relative to the proximal segment of the corresponding sheath segment 1010. Figure 4E 1014, the balloon 1011 may be positioned along any portion of the length of the sheath segment 1010 to assist in performing one or more of a variety of procedures. In addition, the sheath segment 1010 including the balloon 1011 may have any number of shapes and sizes, including any of the lengths and diameters disclosed herein. The balloon 1011 may be made of a variety of materials, including one or more of a biocompatible material and an elastomeric material (e.g., polyurethane, silicone, etc.).

[0050] The outer dimensions of the telescopic vascular sheath 905 can be modified and customized to set the dimensions of the telescopic vascular sheath 905 so that it has dimensions suitable for one or more procedures, such as for performing atraumatic insertion and positioning of the telescopic vascular sheath into one or more of a plurality of vascular systems. Thus, the telescopic vascular sheath can be modified and customized to have outer dimensions and inner dimensions that are safe and effective for performing one or more procedures in one or more of a plurality of vascular systems.

[0051] like Figure 4D As shown, during use, the first sheath segment 910a can be positioned most distally and have a proximal segment 912 with the smallest diameter and a distal opening 925 with the smallest diameter. For example, the distal opening 925 of the first sheath segment 910a can be sized to have a sliding fit with the guidewire 611 to assist in properly steering the distal end 918 of the telescopic vascular sheath 905 into and along the blood vessel. Figure 4D As shown, the second sheath segment 910b can have a distal opening 925 having a diameter that is substantially the same as the proximal section of the first sheath segment 910a. For example, the second sheath segment 910b can have a size that allows the second sheath segment 910a to perform effective expansion.

[0052] Additionally, the tapered distal segment 914 of each sheath segment 910, including the tapered distal wall 924 of each sheath segment 910, can facilitate atraumatic entry of each sheath segment 910 into the blood vessel V. For example, the tapered distal wall 924 can include multiple lengths to achieve one or more of a smooth and gradual increase in diameter along the length of the telescoping vascular sheath 905. In some embodiments, the wall thickness of one or more sheath segments 910 can vary along the length, such as gradually decreasing in wall thickness toward the distal end 918, while maintaining a consistent diameter of the sheath segment passageway, thereby forming the tapered distal segment 914.

[0053] The distance between the distal end 918 of the first sheath segment 910a and the distal end 918 of the second sheath segment 910b can be adjusted by sliding the first and second sheath segments relative to each other. Additionally, the first sheath segment 910a can be retracted proximally and removed from the telescoping vascular sheath 905, leaving the second sheath segment 910b as the most distal sheath segment 910. Similar features and functions can be achieved with any of the sheath segments 910 of the telescoping vascular sheath 905. For example, the second sheath segment 910b can be translated proximally and removed, leaving the third sheath segment 910c as the most distal sheath segment 910. For example, the third sheath segment 910c can assist in performing aspiration, and once the third sheath segment 910c is removed, the fourth sheath segment 910d can assist in performing the function of a guide catheter. Thus, a single telescopic vascular sheath 905 may include multiple sheath segments 910 that may assist in performing various aspects of the procedure without having to remove and replace the telescopic vascular sheath 905 (or only portions of the sheath segments 910 of the telescopic vascular sheath 905, as needed). This may reduce surgical time and cost, and improve patient safety and recovery.

[0054] Figure 5 is a schematic illustration of a blood flow system including a first arterial access device 505a that accesses the right common carotid artery (RCCA) and a second arterial access device 505b that accesses the left common carotid artery (LCCA), both of which are performed via a transcervical approach. The system also includes an arterial return device 530 that communicates with an artery, such as a femoral artery (FA). Each of the arterial access device 505 and the arterial return device 530 has a lumen that can be positioned (surgically or percutaneously via incision) to communicate with a corresponding artery.

[0055] For example, arterial access device 505 may be access system 110, such as Figure 1605, and may include all or a subset of the components of the access system, including one or more of the distal sheath 605, the proximal extension 610, the flow line 615, the adapter, the Y-connector 620, and the hemostasis valve 625. The blood flow system also includes a first shunt 510a, which is fluidly connected to the arterial access device 505a and configured to divert blood flow from the femoral artery to the arterial access device 505a and into the RCCA. The blood flow system also includes a second shunt 510b, which is fluidly connected to the arterial access device 505b and configured to divert blood flow from the femoral artery to the second arterial access device 505b and into the LCCA. In some embodiments, one or more of the first arterial access device 505a, the second arterial access device 505b, and the arterial return device 530 may include an embodiment of the telescopic vascular sheath 905 described herein.

[0056] Still refer to Figure 5 The arterial return device 530 is in fluid communication with the femoral artery FA (or another artery) and is configured to receive blood flow from the FA. The arterial return device 530 is fluidly connected to the return shunt 520, and the blood flow from the corresponding artery (e.g., Figure 5 The blood of the femoral artery in the artery 505 flows through the return shunt 520 toward the arterial access device 505 via the arterial return device 530. The separator 515 divides the single return shunt 520 into separate flow chambers of the first shunt 510a and the second shunt 510b. The flow control element 525 is coupled to the return shunt 520 and is configured to control the blood flow (such as flow rate) through the return shunt 520. A blood filter can also be coupled to the shunt 520.

[0057] In use, blood flowing out of the femoral artery enters the return shunt 520 via the arterial return device 530. The flow control element 525 can control the flow of blood through the return shunt 520 as it flows toward the separator 515. The blood then flows through the first shunt 510a and the second shunt 510b toward the arterial access device 505a and the arterial access device 505b, respectively, where the blood can then flow into the corresponding artery. The LCCA and RCCA can be occluded, such as via an expandable element (such as an expandable balloon) on the corresponding arterial access device 505a and the arterial access device 505b or by using a clamp.

[0058] Although these descriptions contain many details, they should not be interpreted as limitations on the scope of the claimed invention or the invention that may be claimed, but should be interpreted as descriptions of features specific to a particular embodiment. Certain features described in the context of a single embodiment in this specification may also be implemented in combination in a single embodiment. Conversely, the various features described in the context of a single embodiment may also be implemented separately or in any suitable sub-combination in multiple embodiments. In addition, although features may be described above as working in certain combinations and even initially claimed, in some cases, one or more features derived from the claimed combination may be removed from the combination, and the claimed combination may be directed to a sub-combination or a variation of the sub-combination. Similarly, although operations are depicted in a particular order in the accompanying drawings, this should not be understood as requiring such operations to be performed in the particular order shown or in sequence, or performing all of the operations shown to achieve the desired result.

[0059] Although certain versions are described herein in detail to describe various embodiments of methods and apparatus, it should be understood that other versions, embodiments, methods of use and combinations thereof are also possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

1. A telescopic vascular sheath for insertion into a blood vessel, comprising: a plurality of sheath segments, each of the plurality of sheath segments having a tapered distal segment and a proximal segment, each tapered distal segment including a distal opening surface, and each proximal segment including a proximal outer surface, each of the plurality of sheath segments being slidably engaged with at least one adjacent sheath segment along one or more of the distal opening surface and the proximal outer surface; as well as A working passage extends through the plurality of sheath segments and along a longitudinal axis of the telescoping vascular sheath, the working passage providing access to the lumen of the blood vessel.

2. The telescopic vascular sheath of claim 1, wherein each of the plurality of sheath segments is independently movable along the longitudinal axis.

3. The telescoping vascular sheath of claim 1, wherein the proximal segment comprises a tubular shape extending a distance along the longitudinal axis.

4. The telescoping vascular sheath of claim 1, wherein the tapered distal segment comprises a distal opening defined by the distal opening surface.

5. The telescoping vascular sheath of claim 1, wherein the distal opening surface is approximately linear and parallel to the longitudinal axis.

6. A telescopic vascular sheath according to claim 1, wherein the working passage is defined by a first sheath segment among the multiple sheath segments, and the distal opening surface of the first sheath segment has a smaller diameter than the distal opening surface associated with each of the other sheath segments among the multiple sheath segments.

7. The telescoping vascular sheath of claim 6, wherein the distal opening surface of a second sheath segment of the plurality of sheath segments forms a sliding fit along the proximal segment of the first sheath segment.

8. The telescoping vascular sheath of claim 1, wherein the tapered distal section provides for atraumatic insertion of the telescoping vascular sheath into the lumen of tissue and a blood vessel.

9. The telescoping vascular sheath of claim 1, wherein the total length of each of the plurality of sheath segments is from about 5 cm to about 200 cm.

10. The telescoping vascular sheath of claim 1, wherein the diameter of the distal opening is about 0.01 inches to about 20 French.

11. The telescoping vascular sheath of claim 1 , wherein a first sheath positioned proximal to a longitudinal axis of the telescoping vascular sheath comprises a proximal segment having a smaller diameter and a greater overall length than other sheath segments of the telescoping vascular sheath.

12. A telescopic vascular sheath according to claim 1, wherein an outer sheath segment among the multiple sheath segments is positioned at a position farthest from the longitudinal axis of the telescopic vascular sheath, and the outer sheath segment includes a first proximal segment, which has a larger diameter and a shorter length than the proximal segment associated with each of the other sheath segments among the multiple sheath segments.

13. The telescoping vascular sheath of claim 1, further comprising a valve positioned at a proximal end of at least one of the plurality of sheath segments.

14. The telescoping vascular sheath of claim 1, further comprising a port positioned at a proximal end of at least one of the plurality of sheath segments, the port comprising a fluid path in fluid communication with the working passage.

15. The telescoping vascular sheath of claim 1, wherein at least one of the plurality of sheath segments comprises an inflatable balloon.

16. The telescoping vascular sheath of claim 15, wherein the inflatable balloon expands radially outward from the proximal segment when in an inflated state.

17. The telescoping vascular sheath of claim 1, wherein at least one of the plurality of sheath segments provides atraumatic expansion of tissue and atraumatic expansion into the vessel.

18. A method for a telescopic vascular sheath, comprising: advancing the first sheath segment of the telescopic vascular sheath into the lumen of the blood vessel; The second sheath segment of the telescopic vascular sheath is advanced into the lumen of the blood vessel, wherein the telescopic vascular sheath comprises: a plurality of sheath segments, each of the plurality of sheath segments having a tapered distal segment and a proximal segment, the plurality of sheath segments including the first sheath segment and the second sheath segment, each tapered distal segment including a distal opening surface, and each proximal segment including a proximal outer surface, each of the plurality of sheath segments slidably engaging at least one adjacent sheath segment along one or more of the distal opening surface and the proximal outer surface; as well as a working passage extending through the plurality of sheath segments and along a longitudinal axis of the telescoping vascular sheath, the working passage providing access to a lumen of the blood vessel; and The first sheath segment is slidably translated relative to the second sheath segment.

19. The method of claim 18, wherein each of the plurality of sheath segments is independently movable along the longitudinal axis.

20. The method of claim 18, wherein the proximal section comprises a tubular shape extending a distance along the longitudinal axis.

21. The method of claim 18, wherein the tapered distal section includes a distal opening defined by the distal opening surface.

22. The method of claim 18, wherein the distal opening surface is approximately linear and parallel to the longitudinal axis.

23. The method of claim 18, wherein the working passage is defined by a first sheath segment of the plurality of sheath segments, the distal opening surface of the first sheath segment having a smaller diameter than the distal opening surface associated with each of the other sheath segments of the plurality of sheath segments.

24. The method of claim 23, wherein the distal opening surface of a second sheath segment of the plurality of sheath segments forms a sliding fit along the proximal segment of the first sheath segment.

25. The method of claim 18, wherein the tapered distal section provides for atraumatic insertion of the telescoping vascular sheath into tissue and the lumen of a blood vessel.

26. The method of claim 18, wherein the total length of each sheath segment in the plurality of sheath segments is from about 5 cm to about 200 cm.

27. The method of claim 18, wherein the distal opening has a diameter of about 0.01 inches to about 20 French.

28. The method of claim 18, wherein a first sheath positioned proximal to a longitudinal axis of the telescoping vascular sheath comprises a proximal segment having a smaller diameter and a greater overall length than other sheath segments of the telescoping vascular sheath.

29. A method according to claim 18, wherein an outer sheath segment of the multiple sheath segments is positioned at a position farthest from the longitudinal axis of the telescopic vascular sheath, and the outer sheath segment includes a first proximal segment, which has a larger diameter and a shorter length than the proximal segment associated with each of the other sheath segments of the multiple sheath segments.

30. The method of claim 18, wherein the telescoping vascular sheath further comprises a valve positioned at a proximal end of at least one of the plurality of sheath segments.

31. The method of claim 18, wherein the telescoping vascular sheath further comprises a port positioned at a proximal end of at least one of the plurality of sheath segments, the port comprising a fluid path in fluid communication with the working passage.

32. The method of claim 18, wherein at least one of the plurality of sheath segments comprises an inflatable balloon.

33. The method of claim 32, wherein the inflatable balloon expands radially outward from the proximal segment when in an inflated state.

34. The method of claim 18, wherein at least one of the plurality of sheath segments provides atraumatic expansion of tissue and atraumatic expansion into the vessel.

35. A blood flow system comprising: a first arterial access device for accessing a first artery; a second arterial access device for accessing a second artery; as well as Arterial return device for access to the third artery, Wherein the arterial return device is in fluid communication with the first arterial access device and the second arterial access device.

36. The blood flow system of claim 35, wherein one or more of the first arterial access device, the second arterial access device, and the arterial return device comprises a telescoping vascular sheath.

37. The blood flow system of claim 35, further comprising a flow shunt directing fluid flow from the arterial return device to both the first arterial access device and the second arterial access device.

38. The blood flow system of claim 37 further comprising one or more flow control elements that control the flow rate between the arterial return device and the shunt.

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