WO2017058818A1

WO2017058818A1 - Vascular access sheath extension

Info

Publication number: WO2017058818A1
Application number: PCT/US2016/054006
Authority: WO
Inventors: Hossain SAID-MAHMOUDIAN
Original assignee: University of Connecticut
Current assignee: University of Connecticut
Priority date: 2015-09-29
Filing date: 2016-09-27
Publication date: 2017-04-06
Anticipated expiration: 2018-03-29

Abstract

The present disclosure relates generally to equipment and procedures in the field of cardiovascular intervention (e.g., vascular surgery) and, more particularly, to vascular access sheath extension assemblies and related methods of use. The present disclosure provides advantageous systems, assemblies and methods in the field of cardiovascular intervention (e.g., vascular surgery). More particularly, the present disclosure provides advantageous vascular access sheath extension assemblies and related methods of use. The present disclosure provides for a vascular access sheath and/or valve connector having an extension member. One advantageous feature of the extension member is to facilitate the exchange of devices (e.g., monorail devices) over the wire associated with the sheath/valve connector. The present disclosure provides advantageous vascular access sheath extension members/assemblies, systems incorporating such members/assemblies, and methods of use of such members/assemblies for the benefit of such surgical practitioners and their patients.

Description

VASCULAR ACCESS SHEATH EXTENSION

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefit to a U.S. Provisional Application entitled "Vascular Access Sheath Extension," which was filed September 29, 2015 and assigned Serial No. 62/234,169, the contents of which are hereby incorporated by reference in their entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to equipment and procedures in the field of cardio-vascular intervention (e.g., vascular surgery) and, more particularly, to vascular access sheath extension assemblies and related methods of use.

BACKGROUND OF THE DISCLOSURE

In general, equipment and procedures in the field of vascular surgery are known. See, e.g., U.S. Patents Nos. 6,605,062 and 6,106,487, and U.S. Patent Pub. No. 2010/0114081, the entire contents of each being hereby incorporated by reference in their entireties. For example, vascular access sheaths are typically configured and dimensioned to allow catheters, stents, and other interventional/surgical devices to be introduced into blood vessels.

Monorail devices or rapid exchange devices are generally used in a wide variety of medical procedures for endovascular revascularization. For example, balloons can be used to perform angioplasty of a stenotic or an occluded vessel.

On positioning a balloon within a patient vasculature, a wire access through the desired diseased vessel can be secured initially. This wire then can be used to track the balloon and place it at the desired location.

Rapid exchange devices typically have a relatively short guidewire railway extended from the tip of the device to a wire exit port located on the shaft of the device. This is as opposed to over-the-wire devices, which typically have a full-length guidewire railway.

One of the primary difficulties in using rapid exchange devices happens during device exchange, when the wire exit port reaches the sheath ending. At this point the operator should stabilize the wire close to the wire exit port, and walk the device out in a stepwise fashion until the distal end of the device and the guidewire beyond the device are exposed.

This process is not only time consuming but it commonly causes unintentional wire movement, which might pull the wire out of the target vessel or causes other serious complications, especially when a guidewire with embolic protection filter is being used. It is also not unusual to lose significant amount of blood during these exchanges, especially if a touhy-borst connector is required for the procedure.

As such, a need exists among end-users and/or manufacturers to develop vascular access assemblies that include improved features/structures. In addition, a need remains for instruments, assemblies and methods that allow vascular access through designs and techniques that are easily understood and implemented by surgical personnel.

Thus, an interest exists for improved vascular access assemblies and related methods of use. These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the assemblies, systems and methods of the present disclosure.

SUMMARY OF THE DISCLOSURE

According to the present disclosure, advantageous instruments, assemblies and methods are provided for undertaking cardiovascular interventional procedures (e.g., endovascular revascularization).

The present disclosure provides advantageous systems, assemblies and methods in the field of cardiovascular intervention (e.g., vascular surgery). More particularly, the present disclosure provides advantageous vascular access sheath extension assemblies and related methods of use.

Disclosed herein is a vascular access sheath and/or valve connector having an extension member. One advantageous feature of the extension member is to facilitate the exchange of devices (e.g., monorail devices) over the wire associated with the sheath/valve connector. Thus, the present disclosure provides, inter alia, advantageous vascular access sheath extension members/assemblies, systems incorporating such members/assemblies, and methods of use of such members/assemblies for the benefit of such surgical practitioners and their patients.

As noted, during special endovascular procedures, in which mono-rail devices are being used, conventional over the wire device exchanges are difficult, time consuming and can increase the complication rate. Having an advantageous extension member to the access sheath will make mono-rail device exchanges much more operator friendly and will decrease the total procedure time and complication rate. In exemplary embodiments, the extension members of the present disclosure can be utilized in a variety of procedures (e.g., endovascular interventions including carotid stenting, coronary artery interventions, tibial artery interventions and any other endovascular procedures that require monorail device use).

The present disclosure provides for a vascular access sheath extension assembly including a vascular access sheath extending from a proximal end to a distal end, the vascular access sheath defining a sheath channel that is sized and configured for receipt of a surgical device and a guidewire; an extension member extending from a proximal end to a distal end, the distal end of the extension member configured to be positioned adjacent to the proximal end of the vascular access sheath, the extension member defining an extension channel that is sized and configured for receipt of the surgical device and the guidewire; and an opening positioned at the distal end of the extension member.

The present disclosure also provides for a vascular access sheath extension assembly wherein the proximal end of the vascular access sheath includes a valve connector. The present disclosure also provides for a vascular access sheath extension assembly wherein the valve connector is a tuohy-borst fitting.

The present disclosure also provides for a vascular access sheath extension assembly wherein the extension member includes a first extension section and a second extension section, the second extension section configured to telescope in length.

The present disclosure also provides for a vascular access sheath extension assembly wherein the opening of the extension member is configured to expose the surgical device and the guidewire when the surgical device and the guidewire are positioned within the extension channel.

The present disclosure also provides for a vascular access sheath extension assembly wherein the distal end of the extension member is configured to be mounted with respect to the proximal end of the vascular access sheath. The present disclosure also provides for a vascular access sheath extension assembly wherein the distal end of the extension member is configured to be mounted with respect to the valve connector.

The present disclosure also provides for a vascular access sheath extension assembly wherein the surgical device is a monorail device or a rapid exchange device. The present disclosure also provides for a vascular access sheath extension assembly wherein the surgical device includes a railway member configured to receive the guidewire, the railway member extending from a distal end of the surgical device to a guidewire exit port positioned on a shaft of the surgical device; and wherein when the guidewire exit port is positioned adjacent to the proximal end of the extension member, the opening of the extension member exposes the distal end of the surgical device.

The present disclosure also provides for a vascular access sheath extension assembly wherein when the surgical device is proximally removed from the vascular access sheath, the extension member is configured and dimensioned to allow the surgical device to be removed substantially along the same trajectory as the guidewire with substantially no buckling of the guidewire and with substantially no axial guidewire movement.

The present disclosure also provides for a method for performing a procedure, including providing a vascular access sheath extending from a proximal end to a distal end, the vascular access sheath defining a sheath channel that is sized and configured for receipt of a surgical device and a guidewire; providing an extension member extending from a proximal end to a distal end, the extension member defining an extension channel that is sized and configured for receipt of the surgical device and the guidewire, the extension member having an opening positioned at the distal end of the extension member; positioning the distal end of the extension member adjacent to the proximal end of the vascular access sheath; introducing and inserting the guidewire and the surgical device into the extension member and into the vascular access sheath and to a desired anatomical location; performing a surgical procedure of the desired anatomical location by utilizing the surgical device; and removing the surgical device from the vascular access sheath.

The present disclosure also provides for a method for performing a procedure wherein when the surgical device is removed from the vascular access sheath, the extension member is configured and dimensioned to allow the surgical device to be removed substantially along the same trajectory as the guidewire with substantially no buckling of the guidewire and with substantially no axial guidewire movement.

The present disclosure also provides for a method for performing a procedure wherein the proximal end of the vascular access sheath includes a valve connector. The present disclosure also provides for a method for performing a procedure wherein the valve connector is a tuohy-borst fitting.

The present disclosure also provides for a method for performing a procedure wherein the extension member includes a first extension section and a second extension section, the second extension section configured to telescope in length.

The present disclosure also provides for a method for performing a procedure wherein the opening of the extension member is configured to expose the surgical device and the guidewire when the surgical device and the guidewire are positioned within the extension channel.

The present disclosure also provides for a method for performing a procedure wherein the distal end of the extension member is configured to be mounted with respect to the proximal end of the vascular access sheath. The present disclosure also provides for a method for performing a procedure wherein the distal end of the extension member is configured to be mounted with respect to the valve connector.

The present disclosure also provides for a method for performing a procedure wherein the surgical device is a monorail device or a rapid exchange device. The present disclosure also provides for a method for performing a procedure wherein the surgical device includes a railway member configured to receive the guidewire, the railway member extending from a distal end of the surgical device to a guidewire exit port positioned on a shaft of the surgical device; and wherein when the guidewire exit port is positioned adjacent to the proximal end of the extension member, the opening of the extension member exposes the distal end of the surgical device.

Any combination or permutation of embodiments is envisioned. Additional advantageous features, functions and applications of the disclosed systems, assemblies and methods of the present disclosure will be apparent from the description which follows, particularly when read in conjunction with the appended figures. All references listed in this disclosure are hereby incorporated by reference in their entireties. BRIEF DESCRIPTION OF THE DRAWINGS

Features and aspects of embodiments are described below with reference to the accompanying drawings, in which elements are not necessarily depicted to scale.

Exemplary embodiments of the present disclosure are further described with reference to the appended figures. It is to be noted that the various features, steps and combinations of features/steps described below and illustrated in the figures can be arranged and organized differently to result in embodiments which are still within the scope of the present disclosure. To assist those of ordinary skill in the art in making and using the disclosed systems, assemblies and methods, reference is made to the appended figures, wherein:

FIGURES 1A-1C are side views of an exemplary vascular access sheath extension assembly in cooperation with a guidewire and a surgical device according to the present disclosure;

FIGURE 2 is a schematic depiction of the exemplary assembly of FIG. 1C showing guidance to a desired anatomical location/region;

FIGURE 3 is another side view of the assembly of FIGS. 1A-1C, prior to the surgical device and guidewire being introduced therein;

FIGURES 4A-4B are side views of another exemplary vascular access sheath extension assembly according to the present disclosure; FIGURES 5A-5B are side views of another exemplary vascular access sheath extension assembly according to the present disclosure;

FIGURE 6 is a perspective view of another exemplary vascular access sheath extension assembly according to the present disclosure; and

FIGURES 7A-7B are perspective views of an exemplary telescoping extension arm for use with a vascular access sheath extension assembly according to the present disclosure.

DETAILED DESCRIPTION OF DISCLOSURE

The exemplary embodiments disclosed herein are illustrative of advantageous vascular access sheath extension assemblies, and systems of the present disclosure and methods/techniques thereof. It should be understood, however, that the disclosed embodiments are merely exemplary of the present disclosure, which may be embodied in various forms. Therefore, details disclosed herein with reference to exemplary sheath extension assemblies/fabrication methods and associated processes/techniques of assembly and use are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and use the advantageous sheath extension assemblies/systems and/or alternative sheath extension assemblies of the present disclosure.

In accordance with embodiments of the present disclosure, advantageous surgical instruments, assemblies and methods are provided for use during a broad variety of clinical applications and procedures (e.g., vascular access procedures). It is noted that the terms interventional and surgical are used broadly and interchangeably in this disclosure.

The present disclosure provides improved systems, assemblies and methods in the field of cardio- vascular intervention (e.g., vascular surgery). More particularly, the present disclosure provides advantageous vascular access sheath extension assemblies and related methods of use.

In exemplary embodiments, the present disclosure provides for a vascular access sheath and/or valve connector having an extension member. One advantageous feature of the extension member is to facilitate the exchange of devices (e.g., monorail devices) over the wire associated with the sheath/valve connector. The present disclosure provides, inter alia, advantageous vascular access sheath extension members/assemblies, systems incorporating such members/assemblies, and methods of use of such members/assemblies for the benefit of such surgical practitioners and their patients.

Current practice provides that one of the primary difficulties in using rapid exchange devices happens during device exchange. When the wire exit port reaches the sheath ending, the operator should stabilize the wire close to the wire exit port, and walk the device out in a stepwise fashion until the distal end of the device and the guidewire beyond the device are exposed. However, this process is not only time consuming but it commonly causes unintentional wire movement, which might pull the wire out of the target vessel or causes other serious complications.

Moreover, when performing certain endovascular procedures, such as a stent placement through the leg, it is very important to keep the access wire in place after placement. Oftentimes when a user removes the stent catheter (e.g., monorail

catheter/device), unintentional movement of the wire, which might have an embolic protection device on the distal end, can cause serious complications. This is especially so with mono-rail devices, as the thin (e.g., .014" thin) guidewire buckles a little since a user is holding the guidewire at a different angle compared to the angle the catheter/device is being removed at, and because the guidewire is so thin a user needs to take many small steps to remove the catheter.

In general, the present disclosure advantageously provides for a vascular access sheath assembly having an extension member, with the extension member configured to facilitate the exchange of devices (e.g., monorail devices) over the wire associated with the sheath assembly, thereby providing a significant operational advantage as a result.

In exemplary embodiments, the present disclosure provides for an extension member configured to be positioned at or near an end of the vascular access sheath (or at or near an end of the valve connector of the access sheath). The extension member can include a space for holding the guidewire, and generally takes the form of a long tube.

One function of the extension member is to allow the catheter/device (e.g., stent catheter, monorail catheter/device, etc.) to be removed along the same trajectory as the guidewire with substantially no room for buckling of the guidewire. This advantageously allows the removal of the catheter/device to be a one-step and one-person removal process for the catheter/device. It also advantageously provides for less axial movement of the wire, therefore it is faster (the patient is bleeding through the catheters), which thereby provides for quicker operating times. As such, the advantageous extension members/assemblies of the present disclosure are user-friendly, and provide for safer and faster operating procedures. As discussed further below, at least one section of the extension member can be a telescoping section.

Referring now to the drawings, like parts are marked throughout the specification and drawings with the same reference numerals, respectively. Drawing figures are not necessarily to scale and in certain views, parts may have been exaggerated for purposes of clarity.

Referring now to FIGS. 1-4, an exemplary vascular access sheath extension assembly 10 generally includes a vascular access sheath 12 and an extension member 14. In general, vascular access sheath 12 is typically configured and dimensioned to allow catheters, stents, and other interventional/surgical devices 16 (e.g., monorail devices 16) to be introduced into blood vessels.

Exemplary vascular access sheath 12 takes the form of a hollow tubular or elongated sheath. Vascular access sheath 12 extends from a proximal end 11 to a distal end 13, the vascular access sheath 12 defining a sheath channel 15 therethrough or therein that is sized and configured for receipt of a surgical device 16 and a guidewire 18.

As shown in FIG. 2, the vascular access sheath 12 with associated guidewire 18 may be advantageously introduced to a desired anatomical location/region. Thereafter, additional instrumentation and/or devices 16 may be introduced to the anatomical location/region using the guidewire 18 as a guide. In exemplary embodiments and as discussed further below, the surgical device 16 can be a monorail device or a rapid exchange device.

Exemplary extension member 14 takes the form of a hollow tubular or elongated member. The extension member 14 extends from a proximal end 17 to a distal end 19, the distal end 19 of the extension member 14 configured to be positioned adjacent to the proximal end 11 of the vascular access sheath 12 (or positioned at or near a proximal end 21 of a valve connector 20 of the access sheath 12), the extension member 14 defining an extension channel 22 therethrough or therein that is sized and configured for receipt of the surgical device 16 and the guidewire 18.

The vascular access sheath 12 may or may not include or be associated with a valve connector 20 (e.g., tuohy-borst connector/fitting 20). For example, the proximal end 11 of vascular access sheath 12 may include or be mounted with respect to valve connector 20. In such embodiments, the extension member 14 is configured to be positioned at or near a proximal end 21 of a valve connector 20 of the access sheath 12 (e.g., positioned adjacent to and/or mounted with respect to valve connector 20).

In other embodiments, sheath 12 does not include connector 20, and the extension member 14 is configured to be positioned adjacent to the proximal end 11 of the vascular access sheath 12 (e.g., positioned adjacent to and/or mounted with respect to proximal end 11 of sheath 12). In exemplary embodiments and as discussed further below, an opening 24 is positioned at the distal end 19 of the extension member 14. In certain embodiments, the opening 24 of the extension member 14 is configured to expose the surgical device 16 and/or the guidewire 18 when the surgical device 16 and the guidewire 18 are positioned within the extension channel.

As such, disclosed herein is a vascular access sheath 12 and/or valve connector 20 having an extension member 14. One advantageous feature of the extension member 14 is to facilitate the exchange of devices 16 (e.g., monorail devices 16) over the guidewire 18. Thus, the present disclosure provides advantageous vascular access sheath extension assemblies 10, systems incorporating such assemblies 10, and methods of use of such assemblies 10 for the benefit of surgical practitioners and their patients.

As noted, during special endovascular procedures, in which mono-rail devices 16 are being used, conventional over the wire 18 device 16 exchanges are difficult, time consuming and can increase the complication rate. Having an advantageous extension member 14 associated with the access sheath 12 makes mono-rail device 16 exchanges much more operator friendly and decreases the total procedure time and complication rate. In exemplary embodiments, the extension members 14 of the present disclosure can be utilized in a variety of procedures (e.g., endovascular interventions including carotid stenting, coronary artery interventions, tibial artery interventions and any other endovascular procedures that require monorail device 16 use).

As noted, monorail devices or rapid exchange devices 16 are generally used in a wide variety of medical procedures for endovascular revascularization (e.g., balloons can be used to perform angioplasty of a stenotic or an occluded vessel). On positioning a balloon within a patient vasculature, a wire 18 access through the desired diseased vessel can be secured initially. This wire 18 then can be used to track the balloon and place it at the desired location.

As shown in FIGS. IB and 1C, rapid exchange devices 16 typically have a relatively short guidewire railway member 26 extended from the distal end 27 of the device 16 to a wire exit port 28 located on the shaft 30 of the device 16 (as opposed to over-the-wire devices, which typically have a full-length guidewire railway). Stated another way, exemplary surgical device 16 includes a railway member 26 configured to receive the guidewire 18, the railway member 26 extending from a distal end 27 of the surgical device 16 to a guidewire exit port 28 positioned on a shaft 30 of the surgical device 16.

In certain embodiments and as shown in FIG. 1C, when the guidewire exit port 28 is positioned adjacent to the proximal end 17 of the extension member 14, the opening 24 of the extension member 14 exposes the distal end 27 of the surgical device 16, and exposes the guidewire 18 distally beyond the device 16. In exemplary embodiments, the length between the proximal end 17 and distal end 19 of extension member 14 is about 25 to 30 cm, which is just longer than the length between the distal end 27 and exit port 28 of device 16, with the opening 24 configured to expose the distal end 27 and the guidewire 18 distally beyond the device 16 (e.g., when the guidewire exit port 28 is positioned adjacent to the proximal end 17 of the extension member 14 - FIG. 1C).

Current practice (e.g., when no extension member 14 is utilized) provides that one of the primary difficulties in using rapid exchange devices 16 happens during device 16 exchange, when the wire exit port 28 reaches the proximal end 11 of the sheath 12 and/or the proximal end 21 of the connector 20. At this point during conventional practice, the operator should stabilize the wire 18 close to the wire exit port 28, and walk the device 16 out in a stepwise fashion until the distal end 27 of the device 16 and the guidewire 18 distally beyond the device 16 are exposed. This process is not only time consuming but it commonly causes unintentional wire movement, which might pull the guidewire 18 out of the target vessel or causes other serious complications, especially when a guidewire 18 with embolic protection filter is being used. It is also not unusual to lose significant amount of blood during these exchanges, especially if a touhy-borst connector 20 is required for the procedure.

Furthermore, when performing certain endovascular procedures (e.g., carotid angioplasty and stenting), it is very important to keep the wire in place after placement. During conventional practice (e.g., when no extension member 14 is utilized), oftentimes when a user removes the stent catheter 16 (e.g., monorail catheter/device 16), the embolic protection device mounted on the wire moves its position, which requires more intervention. This is especially so with mono-rail devices 16 (e.g., when no extension member 14 is utilized), as the thin (e.g., .014" thin) guidewire 18 buckles a little since a user is holding the guidewire 18 at a different angle compared to the angle the catheter/device 16 is being removed at, and because the guidewire 18 is so thin a user needs to take many small steps to remove the catheter 16.

In exemplary embodiments, the present disclosure advantageously provides for a vascular access sheath assembly 10 having an extension member 14, with the extension member 14 configured to facilitate the exchange of devices 16 (e.g., monorail devices) over the wire 18 associated with the sheath assembly 10, thereby providing a significant operational advantage as a result. As noted, the present disclosure provides for an extension member 14 configured to be positioned at or near the proximal end 11 of the vascular access sheath 12 (or at or near an end 21 of the valve connector 20 of the access sheath 12). The extension member 14 can include a space/opening 24 for holding the guidewire 18, and generally takes the form of a long tube.

One advantageous function of the extension member 14 is to allow the catheter/device 16 (e.g., stent catheter, monorail catheter/device, etc.) to be removed substantially along the same trajectory as the guidewire 18 with substantially no room for buckling of the guidewire 18 (FIGS. 1A to 1C). This advantageously allows the removal of the catheter/device 16 to be a one-step and one-person removal process for the catheter/device 16. It also advantageously provides for less complications as there is substantially no wire 18 movement axially, therefore it is faster, which thereby provides for quicker operating times. As such, the advantageous extension members 14/assemblies 10 of the present disclosure are user- friendly, and provide for safer and faster operating procedures.

FIGURES 4A-4B are side views of another exemplary vascular access sheath extension assembly 100 according to the present disclosure, and FIGURES 5A-5B are side views of another exemplary vascular access sheath extension assembly 200 according to the present disclosure. Assemblies 100, 200 may be structurally and functionally similar to the assembly 10 discussed above with reference to FIGS. 1 A-1C, with certain additional features.

As shown in FIGS. 4A-4B and 5 A-B, extension members 114, 214 of respective assemblies 100, 200 include a first extension section 131, 231 and a second extension section 133, 233. In exemplary embodiments, first extension sections 131, 231 are non-telescoping extension sections, and second extension sections 133, 233 are telescoping extension sections (e.g., sections 133, 233 are configured and dimensioned to telescope in length). As such, assemblies 100, 200 advantageously provide that the length of sections 133, 233 can be shortened to prevent loss of the working device 16 shaft 30 length while device 16 is being utilized, and also provide that the length of sections 133, 233 can be increased when/if desired (e.g., for removal of device 16 from assembly 100, 200).

FIGURE 6 is a side view of another exemplary vascular access sheath extension assembly 300 according to the present disclosure. Assembly 300 is functionally similar to the assembly 10 discussed above with reference to FIGS. 1A-1C, and includes sheath 12, device 16 and extension member 314.

FIGURES 7A-7B are perspective views of another exemplary extension member 400 for incorporation into a vascular access sheath extension assembly, as described above, according to the present disclosure. Extension member 400 is functionally similar to extension members 114 and 214 as shown in FIGS. 4A-4B and 5A-5B, respectively.

Extension member 400 includes a first extension section 402 and a second extension section 404. In exemplary embodiments, first extension section 402 is a non-telescoping extension section, and second extension section 404 is a telescoping extension section (e.g., section 404 is configured and dimensioned to telescope in length). As such, the length of section 404 can be shortened to prevent loss of the working device (not shown) while the working device is being utilized, and in addition, section 404 can be increased when/if desired (e.g., for removal of the working device (not shown) from the assembly (not shown). FIG. 7 A depicts extension member 400 in a extended orientation and FIG. 7B depicts extension member 400 in a condensed orientation. Furthermore, in addition to fully extended and fully contracted, extension member 400 can be partially extended to a length defined by the operator. In some embodiments, second extension section 404 can include three individual sections, however, more or less individual sections can be included without altering the scope and functionality of the device.

Furthermore, exemplary extension member 400 takes the form of a hollow tubular or elongated member. In exemplary embodiments, opening 406 is positioned at the distal end of the extension member 400. In certain embodiments, the opening 406 of the extension member 400 is configured to expose the surgical device (not shown) and/or the guidewire (not shown) when the surgical device and the guidewire are positioned within the extension channel. Located at the proximal side of extension member 400, exit port 408 can be positioned on the face of extension section 404. In certain embodiments, exit port 408 is centrally located on the face of extension section 404. The diameter of exit port 408 depends on the size of the device and/or guidewire required. In one exemplary embodiment, the diameter of exit port 408 can be sized to accept any 7 French device, however, the diameter of exit port 408 is not limited to one diameter and can be changed without altering the scope or functionality of the device.

Whereas the disclosure has been described in connection with sheath extension assemblies for vascular procedures/applications, such description has been utilized only for purposes of disclosure and is not intended as limiting the disclosure. To the contrary, it is to be recognized that the disclosed sheath extension assemblies and related instruments/devices are capable of use for other procedures/applications.

Although the systems/methods of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited to such exemplary embodiments/implementations. Rather, the systems/methods of the present disclosure are susceptible to many implementations and applications, as will be readily apparent to persons skilled in the art from the disclosure hereof. The present disclosure expressly encompasses such modifications, enhancements and/or variations of the disclosed embodiments. Since many changes could be made in the above construction and many widely different embodiments of this disclosure could be made without departing from the scope thereof, it is intended that all matter contained in the drawings and specification shall be interpreted as illustrative and not in a limiting sense. Additional modifications, changes, and substitutions are intended in the foregoing disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure.

Claims

1. A vascular access sheath extension assembly comprising:

a vascular access sheath extending from a proximal end to a distal end, the vascular access sheath defining a sheath channel that is sized and configured for receipt of a surgical device and a guidewire;

an extension member extending from a proximal end to a distal end, the distal end of the extension member configured to be positioned adjacent to the proximal end of the vascular access sheath, the extension member defining an extension channel that is sized and configured for receipt of the surgical device and the guidewire; and

an opening positioned at the distal end of the extension member.

2. The vascular access sheath extension assembly of claim 1, wherein the proximal end of the vascular access sheath includes a valve connector.

3. The vascular access sheath extension assembly of claim 2, wherein the valve connector is a tuohy-borst fitting.

4. The vascular access sheath extension assembly of claim 1, wherein the extension member includes a first extension section and a second extension section, the second extension section configured to telescope in length.

5. The vascular access sheath extension assembly of claim 1, wherein the opening of the extension member is configured to expose the surgical device and the guidewire when the surgical device and the guidewire are positioned within the extension channel.

6. The vascular access sheath extension assembly of claim 1, wherein the distal end of the extension member is configured to be mounted with respect to the proximal end of the vascular access sheath.

7. The vascular access sheath extension assembly of claim 2, wherein the distal end of the extension member is configured to be mounted with respect to the valve connector.

8. The vascular access sheath extension assembly of claim 1, wherein the surgical device is a monorail device or a rapid exchange device.

9. The vascular access sheath extension assembly of claim 8, wherein the surgical device includes a railway member configured to receive the guidewire, the railway member extending from a distal end of the surgical device to a guidewire exit port positioned on a shaft of the surgical device; and wherein when the guidewire exit port is positioned adjacent to the proximal end of the extension member, the opening of the extension member exposes the distal end of the surgical device.

10. The vascular access sheath extension assembly of claim 1, wherein when the surgical device is proximally removed from the vascular access sheath, the extension member is configured and dimensioned to allow the surgical device to be removed substantially along the same trajectory as the guidewire with substantially no buckling of the guidewire and with substantially no axial guidewire movement.

11. A method for performing a procedure, comprising:

providing a vascular access sheath extending from a proximal end to a distal end, the vascular access sheath defining a sheath channel that is sized and configured for receipt of a surgical device and a guidewire;

providing an extension member extending from a proximal end to a distal end, the extension member defining an extension channel that is sized and configured for receipt of the surgical device and the guidewire, the extension member having an opening positioned at the distal end of the extension member;

positioning the distal end of the extension member adjacent to the proximal end of the vascular access sheath;

introducing and inserting the guidewire and the surgical device into the extension member and into the vascular access sheath and to a desired anatomical location;

performing a surgical procedure of the desired anatomical location by utilizing the surgical device; and

removing the surgical device from the vascular access sheath.

12. The method of claim 11, wherein when the surgical device is removed from the vascular access sheath, the extension member is configured and dimensioned to allow the surgical device to be removed substantially along the same trajectory as the guidewire with substantially no buckling of the guidewire and with substantially no axial guidewire movement.

13. The method of claim 11, wherein the proximal end of the vascular access sheath includes a valve connector.

14. The method of claim 13, wherein the valve connector is a tuohy-borst fitting.

15. The method of claim 11, wherein the extension member includes a first extension section and a second extension section, the second extension section configured to telescope in length.

16. The method of claim 11, wherein the opening of the extension member is configured to expose the surgical device and the guidewire when the surgical device and the guidewire are positioned within the extension channel.

17. The method of claim 11, wherein the distal end of the extension member is configured to be mounted with respect to the proximal end of the vascular access sheath.

18. The method of claim 13, wherein the distal end of the extension member is configured to be mounted with respect to the valve connector.

19. The method of claim 11, wherein the surgical device is a monorail device or a rapid exchange device.

20. The method of claim 19, wherein the surgical device includes a railway member configured to receive the guidewire, the railway member extending from a distal end of the surgical device to a guidewire exit port positioned on a shaft of the surgical device; and

wherein when the guidewire exit port is positioned adjacent to the proximal end of the extension member, the opening of the extension member exposes the distal end of the surgical device.