WO2019236994A1 - Bidirectional sheath assembly - Google Patents

Abstract

A bidirectional sheath assembly for use in both diagnostic and vascular intervention procedures, including venous and arterial procedures.

Description

BIDIRECTIONAL SHEATH ASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62/681,840 entitled“BIDIRECTIONAL SHEATH ASSEMBLY” filed on June 7, 2018; the entirety of which is herein incorporated by reference.

FIELD OF nil INVENTION

[0001] This invention relates to a bidirectional sheath assembly for use in both diagnostic and vascular interventional procedures, including venous and arterial procedures. More specifically, the invention relates to an improved bidirectional sheath assembly.

BACKGROUND

[0002] Vascular interventions are performed to diagnose and treat vascular diseases.

Vascular access devices (e.g., catheters, stents, and the like) are used to perform these vascular interventions. These interventions, while perhaps considered somewhat routine, involve procedures that include the percutaneous insertion of various devices in the vasculature of patients (e.g., arteries and veins). Commonly, for example, vascular interventions include the insertion of a device into the femoral artery.

[0003] The femoral artery is a large artery in the thigh and the main supplier of blood from the artery to the leg. The femoral artery enters the thigh from behind the inguinal ligament as a common femoral artery. The common femoral artery is a continuation of the external iliac artery. The femoral artery enters and passes through the adductor canal, and becomes the popliteal artery as it passes through an opening in the adductor magnus near the junction of the middle and distal section of the thigh.

[0004] As an example, one common vascular intervention is angioplasty. Angioplasty involves treating arterial blockages with balloon catheters under x-ray guidance. The balloon which is inserted into the artery is inflated to stretch or expand the lumen of the opened artery, and is subsequently deflated and removed. If this procedure is unsuccessful, a stent may be used which is a technologically designed metal mesh to hold the artery open and remain in place for the rest of the patient’s life or for at least a period of time.

[0005] The antegrade femoral approach is used for the percutaneous treatment of vascular disease of a patient’s lower extremities. Initially, a patient’s cardiologist performs an angiogram to determine if any blockages exist in the arteries of the patient. A catheter, i.e., a small, flexible tube, is inserted into an artery located in the patient’s thigh and dye is then inserted through the catheter into the femoral artery of the groin to enable the doctor to determine if any blockages exist. The dye is viewed on a screen showing the blood flow through the arteries and the location of any blockages. To accomplish this, the catheter is threaded through the arteries to perform the angiogram. The doctor uses an x-ray camera, and the arteries appear in black silhouette on a white background. Blockages appear as white areas. The x-ray camera indicates the heart’s pumping chamber and arteries, and is recorded as a medical digital image.

[0006] Angioplasty follows the angiogram. Angioplasty relates to the treating of the blockages with, for example, a balloon catheter that are guided by x-ray. The balloon catheter includes a thin plastic tube with a small balloon fixed at its end. The doctor places the balloon into the artery, inflates the balloon to stretch the narrow artery, and thereafter the balloon is deflated and removed. Sometimes the balloon does not perform the widening task sufficiently, and the doctor may place a stent in the narrowed area to hold the artery open and remain in place. [0007] When a patient has bilateral leg pain and doppled pulses or absence of a pulse, an angiogram is performed as discussed above. In a situation where both superficial femoral arteries are occluded or show multiple areas of disease, sometimes when both iliac arteries show disease, the following treatments have heretofore been used. It is desirable to treat all areas of the disease or condition using the same procedure, rather than moving the patient, or to bring the patient back for a second procedure. It is common if one superficial femoral artery is occluded or shows areas of disease that both superficial femoral arteries and both iliac arteries may have the disease as well. As explained below, it would be most advantageous if all of the affected key areas and all of the affected arteries could be treated at the same time using the same access point.

[0008] As indicated above, the external iliac becomes the femoral artery when it crosses the inguinal ligament and enters the femoral triangle. The femoral triangle consists of perforating branches that consist of three or four arteries that perforate the adductor magnus, the lateral femoral circumflex artery that wraps around the anterior, lateral side of the femur, and the medial femoral circumflex artery that wraps around the posterior side of the chamber. The femoral artery exits the femoral triangle and continues down the anterior surface of the thigh via a tunnel designated as the adductor canal.

[0009] The point of access to the femoral artery is also known. The femoral puncture is a midpoint of the common femoral artery, and the target is the segment between the inferior epigastric artery and the bifurcation of the superficial and profunda branches. It is usually at the level of the center of the femoral head.

[0010] Before the puncture, the course and direction of the artery must be carefully identified. The femoral artery is felt as a cylinder with a center line at the highest point, and the edges of the two lower points on each side. The femoral artery pulse is thereby located and a local anaesthesia is given. A metal clamp may optionally be applied, if necessary, at the entry site and a fluoro exam is done to make sure that the clamp is properly related to the femoral head. The needle is then positioned for the best puncture.

[0011] According to the foregoing known procedure, the skin near where the artery is punctured is nicked with a blade over the guidewire, and the entry track is enlarged with a clamp.

[0012] There are different techniques that can be used following the arterial puncture. In one procedure, a through-and-through puncture technique is used, and in another procedure a single, front wall arterial puncture is used to reduce the chance of bleeding from an inadvertent back wall puncture leak.

[0013] Once the guidewire is located in the iliac artery, the needle is removed using firm hand pressure applied over the puncture site, and the guidewire is pinched to secure it while the sheath is placed over the wire. The sheath-dilator assembly is advanced with a rotary motion while holding the guidewire straight and stable. The dilator and guidewire are removed together. The sheath is aspirated and flushed through the side arm with heparinized saline.

[0014] After the catheterization is completed and the patient is stable, the sheath is pulled out. It is determined whether the patient needs more analgesia or local anaesthetic. The dorsalis pedis artery pulse is checked, and the sheath is aspirated and flushed to clear any thrombi. There are further steps which will not be as set forth at this time but which should be understood and appreciated by one skilled in the art.

[0015] Another procedure for femoral access using a modified Seldinger technique is known. In this procedure, micro puncture equipment is prepared by inserting a dilator into a particular sheath. A guide wire is partially pulled out from the sheath to ensure no difficulties will be encountered inserting it into the needle. The components of the micro puncture set include a 7cm 21G needle that is still in a protective shield that will be discarded when the needle is ready for use. The wire is a 40cm 0.0l8in wire. Once the needle is introduced into the blood vessel, the wire is advanced into the vessel through a needle hub. The needle is then retracted and removed. And introducer is advanced fully into the sheath such that its cap securely clips on to the sheath hub. The tip of the introducer extends beyond the tip of the sheath. The unit is threaded over the wire into the blood vessel. Once the sheath is approximately positioned, the introducer and wire are simultaneously removed, leaving the sheath in place.

[0016] According to the present procedure, after the groin region is prepped and draped, the pulse is palpitated for the femoral artery. The anterior, superior iliac crust is spanned to the pubic symphysis with a hand to approximate the ilioinguinal ligament. The span is bisected with the other hand to indicate the location of the femoral artery. Palpitation is conducted for the pulsations of the femoral artery. The plan of the puncture site is then confirmed and a segment of the artery is immobilized. The skin overlaying the immobilized segment is infiltrated with a local anaesthesia. The tissues overlying the artery are also infiltrated and aspirated prior to injecting, to ensure the lidocaine is not administered into the arterial lumen. A small stab incision is made in the skin overlying the immobilized segment. The needle is probably inserted. When the artery is punctured and the needle is at its lumen, blood emanates from the needle hub. The advancement of the needle is stopped to prevent going through the opposite arterial wall. The wire is then advanced through the needle hub and introduced into the arterial lumen. Once the wire is properly inserted into the arterial lumen, the needle is retracted over the wire while making sure that a segment of the wire is always under control. A pre-assembled micro puncture sheath with a dilator over the wire is introduced into the artery with a segment of the wire still being held. The wire is then withdrawn along with the introducer leaving the sheath in the artery. The hub is covered with the operator’s thumb to prevent unnecessary blood loss. A J wire is introduced into the sheath until it is in the artery well beyond the sheath, while access to a segment of the wire is always insured. The small sheath is withdrawn over the wire.

[0017] The artery is compressed manually and a sheath is introduced over the wire into the arterial lumen. The wire and sheath introducer are retracted and removed when the sheath has been positioned in the artery. The sheath is connected to the previously prepared tubing with a neonatal transducer to ensure a continuously running heparinized saline solution.

[0018] These and other techniques are known in the art. A known disadvantage with conventional devices for conducting these known procedures and techniques is that the guidewire and the catheter cannot both simultaneously be removed from the patient. If simultaneous removal occurs, then the procedure must typically end. At the same time, another known problem with conventional devices is that the working direction of the device cannot be easily reversed in the patient without disadvantageously risking the simultaneous removal discussed above. Therefore, an improved sheath assembly is provided to facilitate the reversal of the working direction while reducing, if not eliminating, the risk of simultaneous and total removal of the device from the patient.

SUMMARY

[0019] An object of the present invention is to provide a device that allows for the completion of different diagnostic and/or therapeutic vascular interventions from a single access point. For example, the device may allow interventions in all affected areas in all of the affected arteries using the same access point into a femoral artery.

[0020] In one embodiment, the innovation may be used for angioplasty, and in particular may include a bi-directional sheath for use in multiple affected areas or vessels (e.g., arteries) during a single procedure and using the same access point.

[0021] Another object of the present invention is to provide a bi-directional sheath for enabling a guidewire(s) to be placed to access multiple locations (e.g., to provide access to both directions of a femoral artery).

[0022] A still further object of the present invention is to direct the guidewire antegrade down each leg from the femoral artery without risking the migration or damaging of stents which have been placed in the artery.

[0023] Another object of the present invention is to use a single access into the femoral artery to conduct a diagnostic angiogram in both directions in the femoral artery.

[0024] Another object of the present invention is to provide a sheath which can do the foregoing, which can also be used for other interventions, including, but not limited to diagnostic, interventional ballooning, stenting, using the thrombectomy devices and closure devices.

[0025] These and other objects will be apparent from the invention as described below and from the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Aspects of the disclosure are understood from the following detailed description when read with the accompanying drawings. For purposes of illustration, elements, structures, etc. of the drawings may not necessarily be drawn to scale. Accordingly, the dimensions of the same may be arbitrarily increased or reduced for clarity of discussion, for example.

[0027] FIG. 1 is a diagram of a retrograde femoral artery intervention using a sheath in a common femoral artery.

[0028] FIG. 2 is a diagram of an antegrade approach femoral artery intervention using a sheath in the superficial femoral artery.

[0029] FIG. 3 is a diagram of a cross-sectional view of a sheath according to the innovation in the artery for reversal of direction.

[0030] FIGS. 4A and 4B are diagrams of the distal end of the bidirectional sheath according to embodiments of the innovation showing different orientations for placement of the guide wire.

[0031] FIG. 5 is a diagram of a cross-sectional view of the bidirectional sheath according to an embodiment of the innovation wherein the balloon is deflated.

[0032] FIG. 6 is a diagram of a side view of the bidirectional sheath according to an embodiment of the innovation

[0033] FIG. 7. is a diagram of a cross-sectional view of the bidirectional sheath according to an embodiment of the innovation wherein the balloon is inflated.

[0034] FIG. 8 is a diagram depicting redirection of the bidirectional sheath down the artery.

[0035] FIGS. 9A and 9B are diagrams depicting cross-sectional views of a sheath according to an embodiment of the innovation.

[0036] FIGS. 10 and 10B are diagrams of a front view (FIG. 10) and a side view (FIG.

10B) of the distal end of the bidirectional sheath inside an artery according to an embodiment of the innovation.

[0037] FIG. 11 is a diagram depicting a side view of the bidirectional sheath having a notch at the distal end inside an artery with the balloon inflated according to an embodiment of the innovation.

[0038] FIG. 12 is a diagram demonstrating the advantage of an embodiment having a notch at the distal end rather than a side hole for use in a small artery.

[0039] FIG. 13 is an illustration of an example flow chart of a method for reversing the direction of the sheath according to an embodiment of the innovation

DETAILED DESCRIPTION

[0040] According to an aspect, the innovation provides a bidirectional (reversible) sheath for use in both diagnostic and interventional vascular procedures, including both venous and arterial procedures.

[0041] As described above, there are numerous procedures and interventions that require vascular access devices. An important part of the vascular access device is the sheath that permits insertion of various devices, including guidewires, catheters, stents, and the like into the vasculature of a patient in need of diagnosis and/or treatment.

[0042] Oftentimes, when a patient undergoes a procedure to diagnose a vascular disease, it is found that treatment for a vascular disease is required. Thus, many diagnostic cases become cases that require medical intervention. Most often, this means that the patient must undergo at least one other invasive procedure to provide treatment for the vascular disease. This can oftentimes mean that a patient will be required to spend additional time in a hospital waiting for the treatment procedure to be scheduled while recovering from the diagnostic procedure or must schedule additional out-patient procedures to be done at a later time.

[0043] The location of the access point for any vascular procedure is selected carefully to ensure the best outcome for the procedure while minimizing risk to the patient such as the risk of hematomas and infections. The access location may be limited by, for example, patient anatomy, including the location and condition of the vasculature.

[0044] In some cases, the patient may be treated at the time of diagnosis. However, this treatment requires additional vascular access devices (e.g., catheter, stent, etc.) and requires the creation of another access point. The more access points that are created, then the greater the risk of infection and adverse outcomes for the patient.

[0045] According to an embodiment, the innovative bidirectional sheath allows the diagnostic and treatment procedures to be done at the same time. The bidirectional sheath according to the innovation provides an access device that allows for reconfiguration of the sheath to permit insertion of various devices (e.g., guide wires, catheters, etc.) without the need for additional access points. Thus, multiple procedures can be completed at one time.

[0046] The innovation is now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the subject innovation. It may be evident, however, that the innovation can be practiced without these specific details. In other instances, well-known structures and devices may be shown in block diagram form in order to facilitate describing the innovation.

[0047] With reference to FIGs. 1 and 2 , there is shown and depicted an illustrative diagram of a retrograde femoral artery intervention using a sheath 100, 200 in a common femoral artery (A) in different directions.

[0048] With reference to FIGs. 3-12, in some embodiments of the innovation, a bidirectional sheath 300 is shown and provided. The Figures depict various configurations having sheath 300 comprising a tubular member 10 having a proximal end 12, a distal end 14, and with a lumen 16 extending through tubular member 10 from proximal end 12 to distal end 14. Sheath 300 further comprises an occlusion device 20 (e.g., a balloon) attached at a distal end 14 on an outside surface of the tubular member 10. The tubular member 10 may be percutaneously inserted into a vessel of a patient (e.g., the femoral artery) (A). When a first procedure is completed (e.g., an angiogram), the balloon 20 attached to the tubular member 10 may be inflated by a balloon inflation means 26 (inflation port) to prevent the sheath 300 from being fully removed from the vessel. While still inserted, the sheath 300 can be repositioned securely to provide access to other areas of the body. For example, the sheath 300 can be easily and securely directed from the antegrade to the retrograde to provide access to different areas of the artery. In this example, an angled guide wire 22 could be inserted into the lumen 16 of tubular member 10 at the proximal end 12 and through a side opening 18 (e.g., small elongated access hole, a notch 30 (shown in FIGS. 9-12), or a slit in the tubular member). In one embodiment, the side opening 18 is distal to the balloon 20, thus allowing the angled guide wire 22 to be redirected in the opposite arterial direction and maintaining a single access point for at least two procedures or for the same procedure in different arterial locations. In one embodiment, the bidirectional sheath 300 may be used for any number of procedures as needed.

[0049] FIG. 3 depicts an embodiment according to in the innovation that includes an inflation port 26 for inflating occlusion device 20. In FIG. 3, the occlusion device (e.g., a balloon) is inflated.

[0050] FIGs. 4A and 4B are a close up view of the distal portion of the sheath 300 according to an embodiment of the innovation showing guidewire 22 inserted into the lumen 16 and exiting through opening 18 of the tubular member 10.

[0051] FIG. 5 depicts a sheath 300 having a guidewire inserted 22 through the lumen 16 and into the hole 18. The occlusion device (e.g., balloon) is deflated in this depiction.

[0052] Turning now to FIG. 6, use of the sheath 300 is depicted. The sheath is inserted into a vessel. The guidewire is inserted into the lumen and out the hole 18 in the tubular member 10. The occlusion device in this depiction is deflated.

[0053] As shown in the Figures, a flush port 28 is also provided. Flush port 28 may be any such conventional flush port known in the art and as understood by one skilled in the art.

[0054] The ability to perform multiple procedures using a single entry point is beneficial because it reduces the risks associated with placing an additional access device and allows a patient to receive needed interventions more quickly. For example, presently a patient who requires intervention after a diagnosis of vascular disease or who requires intervention at multiple locations often needs to wait for a follow-up appointment and must wait for an opening in the schedule for such a procedure and/or for the patient to recover from the initial procedure.

[0055] In one example, a patient with bilateral leg pain may be evaluated. The evaluation may include an angiogram to determine whether there is any occlusion or disease causing the bilateral leg pain. The angiogram is performed and shows that both superficial femoral arteries (SFAs) are occluded or show multiple areas of disease. In addition, both iliac arteries show disease. Previously, the patient may have had to endure multiple procedures (including the angiogram) to intervene in each of these areas. Using the bidirectional sheath according to the innovation, each of these areas could be treated as the same time as the angiogram, using the same access point for each procedure.

[0056] In another example, the bidirectional sheath could be used for accessing the popliteal artery for interventions (e.g., ballooning and/or stenting) of the SFA. If other interventions are necessary, the direction of the bidirectional sheath could then be reversed for access to the tibial arteries.

[0057] The bidirectional sheath according to the innovation can be used in the same manner and for the same purpose as sheaths currently used for vascular diagnoses/interventions such as diagnostic/interventional ballooning, stenting, and with thrombectomy devices and closure devices. If a larger/longer sheath is needed to complete the intervention, the bidirectional sheath may be used to redirect the guidewire to provide access to another area and then removed and the larger sheath inserted to complete the intervention.

[0058] In one embodiment, the bidirectional sheath 300 according to the innovation may be used in venous procedures.

[0059] According to an aspect, the innovation provides a bidirectional sheath 300 for use with a vascular access device which is known and understood in the art. In one embodiment, the sheath 300 may comprise a tubular member 10 having a distal end 14, a proximal end 12, and a lumen 16 that extends longitudinally from the distal end 14 to the proximal end 12; and at least one occlusion device 20, which may advantageously be an inflatable and deflatable occlusion device such as a balloon, attached to the outside surface of the sheath 10. The tubular member 10 has an access opening at the proximal and distal ends which is known and understood in the art. In one embodiment, the at least one occlusion device 20, such as a balloon, is located toward the distal end 14 of the tubular member 10. It will be appreciated that the balloon 20 can be located on any area of the tubular member 10 that is designed to be inserted into the vessel 500 of a patient. In an alternative embodiment, the occlusion device 20 may include expandable/contractible elements (e.g., to secure/anchor the sheath inside the vasculature. The at least one occlusion device 20 may comprise any suitable material that is known or standard in the art.

[0060] In an embodiment, the tubular member 10 may comprise any suitable material for percutaneous use, including polymers and metals.

[0061] In an embodiment, the vascular access device/bidirectional sheath 10 includes an inflation means 26 for inflating the occlusion device 20 (e.g., balloon) attached to the tubular member 10 such as via a side port for balloon inflation. In an embodiment, the inflation means 26 may include a syringe attached to a connecting member. The balloon 20 may be attached to a connecting member (e.g., a wire, tube, shaft, etc.) having a lumen through which air or fluid can pass so as to inflate the balloon. In one embodiment, the tubular member 10 may include another lumen that is in communication with the balloon, such that an inflation means can inflate the balloon via the lumen. Occlusion device 20 may advantageously be attached to sheath 10 at the desired location on tubular member 10 via conventional attachment methods. Alternatively, occlusion device 20 may be formed as an integral component of sheath 10 at the desired location on tubular member 10.

[0062] In one embodiment, the tubular member 10 includes a hole 18, notch 30, or a slit through which a guide wire or other device (e.g., a catheter, stent, catheter balloon, etc.) may be threaded. In one embodiment, the guide wire 22 is an angled guide wire. In one embodiment, the hole 18, notch 30, or slit is located toward the distal end 14 of the tubular member 10. As is appreciated, the hole 18 can be located at any portion of the tubular member 10, so long as hole 18 is located in a portion of tubular member 10 that is inserted into a vessel 500 of a patient. In another embodiment, the tubular member 10 may include at least one hole 18 (i.e., multiple holes) arranged around the outer periphery of the tubular member 10 towards the distal end 14 of the tubular member 10 (See, e.g., FIG. 7.).

[0063] In one embodiment, the bidirectional sheath 10 may include a hub 32 at the proximal end 12. See FIG. 3. The hub 32 may include a passage that extends through the hub 32 and is in communication with the lumen 16 of the tubular member 10 such that a guidewire, catheter, etc., can pass through the passage of the hub 32 and through the lumen 16 of the tubular member 10. In one embodiment, the hub 32 may include a secondary passage that extends laterally and is in communication with the lumen for injection of fluids into the lumen.

[0064] In one embodiment, the hub 32 may be color-coded to indicate the gauge of the sheath. In one embodiment, the hub 32 may include a marking to indicate that the sheath 10 is a bidirectional sheath. The marking may be color-coded (e.g., the hub may be green to indicate gauge and have a white stripe to indicate that it is a bidirectional sheath) or some other type of marking. In one embodiment, the hub 32 may further include an indicator 34 (FIGs. 9A and 9B) which corresponds to the location of the respective hole 18, notch 30 or slit, and to thereby to mark the location of the hole 18, notch 30, or slit to facilitate insertion of the device (e.g., guide wire). For example, the hub 32 may include a vertical indicator that indicates the side of the sheath that includes the access hole.

[0065] FIGs. 8A-8C depict various stages of use of the bidirectional sheath 300 according to the innovation. FIG. 8A depicts a sheath that has been inserted into a vessel with a guide wire 22 inserted through the lumen of the tubular member 10 and threaded through the side hole 18. According to one embodiment, and as described below, inflation of the balloon 20 permits repositioning of the sheath such that a different portion of the patient’s vasculature may be accessed and/or a different vascular intervention procedure may be performed. FIG. 8B depicts a dilator and sheath provided for re-entry over the guide wire. FIG. 8C depicts the use of the sheath with the balloon deflated.

[0066] As depicted in FIGs. 9A and 9B, in some embodiments, a radiopaque marker 24 is provided at an advantageous location of tubular member 10. Marker 24 may indicate the location of the access hole 18 or notch 30 to facilitate placement of the guide wire 22 or other device. [0067] In one embodiment in accordance with the present innovation, the side opening is a hole 18, a notch 30 (FIGs. 10A and 10B) or a slit in a portion of the distal end 14 of the tubular member 10. In one embodiment, the balloon 20 may be located just above the notch 30 or slit as shown in FIGs 11 and 12. This arrangement of the balloon close to the notch 30 or slit at the distal end 14 of the tubular member 10 may facilitate insertion of the guide wire 22 and may also facilitate reversal of the direction of the sheath 300 in smaller vessels. For example, if a patient has a smaller than average artery, the notch 30 (or slit) allows for a relatively smaller portion of the sheath to remain within the artery of the patient so that there is more room to maneuver the guide wire 22 because the sheath 300 is not abutting the bottom wall or back wall of the artery. (See, e.g., FIGs. 11 and 12.)

[0068] According to an aspect, the innovation provides a method for vascular intervention comprising the percutaneous insertion of a bidirectional sheath in the vessel of a patient by securely manipulating the sheath to alter or reverse its direction while the sheath remains securely inserted in the vessel. The balloon attached to the tubular member of the sheath may be inflated just prior to the manipulation to secure the sheath and to prevent the sheath from being pulled out of the vessel entirely which would disadvantageously prevent an additional or continued intervention from occurring during the instant procedure.

[0069] In one embodiment, the sheath may be used in a vascular interventional procedure.

[0070] FIG. 13 sets forth an example flow chart describing an embodiment of a method of repositioning the sheath 1300 according to the innovation. After a first vascular intervention (e.g., diagnosis procedure or treatment procedure) has been completed, the sheath can be repositioned so as to access a different part of the vasculature and/or perform a second (or more) intervention.

[0071] At 1301, after a first vascular intervention has been completed, the occlusion device is inflated to secure at least a portion of the sheath inside the vessel. In some embodiments, the sheath may need to be manipulated (e.g., pulled partially in the artery) to position the sheath properly prior to inflating the occlusion device (e.g., balloon). Once inflated, the occlusion device acts to secure the sheath within the vessel so that the sheath is not fully removed from the vessel during repositioning. Once inflated, the sheath may again need to be manipulated so as to provide adequate access for manipulation of the guide wire at 1302. At

1302, the guidewire may be positioned such that it does not extend significant beyond the end of the sheath. In one embodiment, the guidewire may be positioned above the side opening. At

1303, the sheath may need to be rotated to position the side opening in the direction necessary to complete the second (or more) vascular intervention. As described above, in one embodiment, the sheath may include a plurality of side openings. At 1304, the guide wire may be positioned and/or advanced through the lumen of the sheath such that it threads through the side opening. Once threaded through the side opening, the guide wire may be advanced in the direction necessary for the second (or more) vascular intervention. It will be appreciated that the method described above and in FIG. 13 can be modified to accommodate the needs for various vascular interventions.

[0072] What has been described above are preferred aspects of the present innovation. It is of course not possible to describe every conceivable combination of components or

methodologies for purposes of describing the present innovation, but one of ordinary skill in the art will recognize that many further combinations and permutations of the present innovation are possible. Accordingly, the present innovation is intended to embrace all such alterations, combinations, modifications, and variations that fall within the spirit and scope of the appended claims.

[0073] While, for purposes of simplicity of explanation, the one or more methodologies shown herein, e.g ., in the form of a flow chart, are shown and described as a series of acts, it is to be understood and appreciated that the subject innovation is not limited by the order of acts, as some acts may, in accordance with the innovation, occur in a different order and/or concurrently with other acts from that shown and described herein. For example, those skilled in the art will understand and appreciate that a methodology could alternatively be represented as a series of interrelated states or events, such as in a state diagram. Moreover, not all illustrated acts may be required to implement a methodology in accordance with the innovation.

Claims

CLAIMS What is claimed is:

1. A bidirectional sheath comprising:

a tubular member having a proximal end and a distal end;

a lumen that extends longitudinally from the proximal end to the distal end of said tubular member;

a hub at the proximal end of the tubular member comprising a passage operatively connected to the lumen and configured to accommodate a device for diagnosing or treating a vascular condition;

at least one occlusion device attached to an outside surface of the tubular member; and

at least one opening in the outside surface of the tubular member configured such that the device for diagnosing or treating a vascular condition may be threaded from the lumen through the at least one opening.

2. The bidirectional sheath of claim 1, wherein the device for diagnosing or treating a vascular condition is selected from a guidewire, a catheter, and a stent.

3. The bidirectional sheath of claim 2, wherein the device for diagnosing or treating a vascular condition is an angled guidewire.

4. The bidirectional sheath of claim 1, wherein said at least one opening is selected from the group of openings consisting of a hole, a slot and a notch.

5. The bidirectional sheath of claim 4, wherein the at least one opening is a hole.

6. The bidirectional sheath of claim 4 comprising a plurality of openings arranged around the outside surface of the tubular member

7. The bidirectional sheath of claim 1, wherein the occlusion device is an inflatable occlusion device.

8. The bidirectional sheath of claim 7, wherein the inflatable occlusion device is a balloon.

9. The bidirectional sheath of claim 7, wherein the tubular member further comprises a second lumen operatively connected to the inflatable occlusion device so as to facilitate inflation of the inflatable occlusion device.

10. A vascular access device configured to be inserted into the vasculature of a patient comprising:

a bidirectional sheath comprising;

a tubular member having a proximal end and a distal end;

a lumen that extends longitudinally from the proximal end to the distal end of said tubular member;

at least one occlusion device attached to an outside surface of the tubular member operatively connected to an inflation means, wherein the occlusion device is configured such that the tubular member cannot be removed from the vasculature of the patient once it is inserted; and

at least one opening in the tubular member.

11 The vascular device according to claim 10, wherein said at least one opening is at least one selected from the group of openings consisting of a hole, a slot and a notch.

12. The vascular device according to claim 10, wherein said occlusion device is an inflatable occlusion device.

13. The vascular device according to claim 12, wherein said inflatable occlusion device is a balloon.

14. The vascular device according to claim 11 wherein the tubular member comprises a plurality of openings arranged around the outside surface of the tubular member.

15. A method of vascular intervention comprising:

inserting a bidirectional sheath into a vessel of a patient, wherein the bidirectional sheath comprises:

a tubular member having a proximal end and a distal end;

a lumen that extends longitudinally from the proximal end to the distal end of said tubular member;

at least one occlusion device attached to the outside surface of the tubular member operatively connected to an inflation means; and

at least one opening in the tubular member;

inserting a first vascular device through the bidirectional sheath;

completing at least one vascular intervention;

removing the first vascular device;

inflating the balloon to prevent removal of the bidirectional sheath from the patient; and

manipulating the bidirectional sheath to permit the inserting of a second vascular device through the at least one opening in a direction that is different from the direction of the first vascular device.

16. The method of claim 15, wherein the second vascular device is a vascular device that is different from the first vascular device.

17. The method of claim 15, wherein the occlusion device is a balloon.

18. The method of claim 15 wherein the tubular member comprises a plurality of openings arranged around the outside surface of the tubular member.

19. The method of claim 15, further comprising removing the bidirectional sheath from the vessel of the patient and inserting a different sheath.