Patent Description:
The invention relates to a vascular access device declotting system according to claim <NUM>.

The written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:.

Many patients who suffer from kidney malfunction undergo hemodialysis to remove waste products from their blood. Hemodialysis generally requires access to an adequate blood supply. In some cases, access to a blood supply may be established via an arteriovenous fistula. In other circumstances, other methods for accessing the blood supply are used.

For example, in some embodiments, access to a blood supply is established via an arteriovenous graft. In other embodiments, access to a blood supply is established via a graft that extends from a peripheral blood supply to an outlet that is positioned in the central venous system.

Certain embodiments disclosed herein may be used to establish an artificial blood flow path, such as along a non-natural or artificial conduit, that improves or provides alternative access to a blood supply. The artificial flow path may be used, for example, to bypass a central venous stenosis. In some embodiments, the artificial blood flow path, when implanted into a patient, is fully subcutaneous. Access to a blood supply that is provided by an artificial flow path may be particularly advantageous for access in hemodialysis patients (such as hemodialysis patients who have exhausted peripheral venous access sites for fistulas).

The components of the embodiments as generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations. While various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

The phrase "coupled to" is broad enough to refer to any suitable coupling or other form of interaction between two or more entities. Thus, two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component. The phrase "attached to" refers to interaction between two or more entities which are in direct contact with each other and/or are separated from each other only by a fastener of any suitable variety (e.g., an adhesive). The phrase "fluid communication" is broad enough to refer to arrangements in which a fluid (e.g., blood) can flow from one element to another element when the elements are in fluid communication with each other. Unless otherwise stated, all ranges include both endpoints and all numbers between the endpoints.

The terms "central" and "peripheral," as used herein, are opposite directional terms along a flow path of the vasculature. For example, a peripheral end of a device or component is the end of the device or component that is furthest from the heart when the device or component is assembled and implanted within the patient. The central end portion refers to the opposite end or the end closest to the heart of the patient when the device is in use. Further, this reference frame is applied herein to devices configured or designed to have one end (a central end) positioned closer to the heart when the device is in use, whether or not the device itself is deployed within the body.

<FIG> provides a perspective view of a vascular access assembly <NUM>. As shown, the vascular access assembly <NUM> includes a first tubular conduit <NUM>, a second tubular conduit <NUM>, and one or more connectors or adaptors <NUM>. In some embodiments, the first tubular conduit <NUM> may have an initial length of at least <NUM>, at least <NUM>, at least <NUM>, or at least <NUM>. For example, the first tubular conduit <NUM> may have an initial length of between about <NUM> and about <NUM> or between about <NUM> and about <NUM>. In certain embodiments, the first tubular conduit <NUM> has an internal diameter of between about <NUM> and about <NUM>. For example, the internal diameter of the first tubular conduit <NUM> may be between about <NUM> and about <NUM>.

In various embodiments, the first tubular conduit <NUM> may be resistant to kinking and/or crush forces. The first tubular conduit <NUM> may be reinforced. For example, the first tubular conduit <NUM> may be reinforced with nitinol, such as braided nitinol, which can provide resistance to kinking and/or crush forces. More specifically, in various embodiments, the first tubular conduit <NUM> may include silicone-coated nitinol.

In some embodiments, the first tubular conduit <NUM> may include one or more radiopaque bands or markers (not shown). For example, the first tubular conduit <NUM> may include a radiopaque band adjacent the central end portion of the first tubular conduit <NUM>. The radiopaque band(s) or marker(s) may facilitate fluoroscopic placement of the first tubular conduit <NUM> within a patient.

In certain embodiments, the second tubular conduit <NUM> may be configured to be accessed for hemodialysis. In other words, during some medical procedures (e.g., hemodialysis), the second tubular conduit <NUM> may be accessed in lieu of the natural vasculature of a patient. In various embodiments, the second tubular conduit <NUM> may include and/or consist of polytetrafluoroethylene (PTFE) (e.g., such as expanded PTFE (ePTFE), rotational spun PTFE, or electrospun PTFE). In various other embodiments, the second tubular conduit <NUM> may include silicone, a fibrous polymer, or another suitable material.

In some embodiments, the second tubular conduit <NUM> may include a puncturable and self-sealing wall such that the wall may be punctured by insertion of a needle and then reseal upon withdrawal of the needle. The self-sealing wall may be of any suitable composition. In certain embodiments, the self-sealing wall may be a multi-layered construct. For example, the self-sealing wall may include an outer layer, an inner layer, and at least one tie layer disposed between the outer layer and the inner layer. One or more of the outer layer and the inner layer may include PTFE. For example, the outer layer may include and/or consist of expanded PTFE while the inner layer may include and/or consist of rotational spun or electrospun PTFE. The tie layer may include an elastomer such as elastomeric silicone. Due, at least in part, to the properties of the silicone, the resulting construct may be self-sealing. In other words, when a needle that has been inserted through the wall is withdrawn from the second tubular conduit <NUM>, the wall may seal itself, thereby preventing leakage of blood from the second tubular conduit <NUM>.

In various embodiments, the second tubular conduit <NUM> may have an initial length of at least <NUM>, at least <NUM>, or at least <NUM>. For example, the second tubular conduit <NUM> may be between about <NUM> and about <NUM> or between about <NUM> and about <NUM> in length. In some embodiments, the second tubular conduit <NUM> may have an internal diameter of between about <NUM> and about <NUM>. For example, the internal diameter of the second tubular conduit <NUM> may be between about <NUM> and about <NUM>.

In some embodiments, both the first tubular conduit <NUM> and the second tubular conduit <NUM> may be self-sealing. In some other embodiments, only the second tubular conduit <NUM> may be self-sealing.

In certain embodiments, one or both of an inner surface and an outer surface of the vascular access assembly <NUM> may be associated with a therapeutic agent. In other words, the therapeutic agent may be disposed on or embedded within a surface of the vascular access assembly <NUM>. The therapeutic agent may be released from the surface(s) of the vascular access assembly <NUM> to deliver a therapeutically effective dose of the therapeutic agent to the patient when the vascular access assembly <NUM> is implanted within a patient. In various embodiments, a first therapeutic agent is associated with the inner surface of the vascular access assembly <NUM> and a second therapeutic agent that differs from the first therapeutic agent is associated with the outer surface of the vascular access assembly <NUM>. In such embodiments, both the first therapeutic agent and the second therapeutic agent may be delivered into the bloodstream of the patient in therapeutically effective doses when the vascular access assembly <NUM> is implanted within the patient. In some embodiments, heparin may be used as a therapeutic agent. The therapeutic agent may reduce or be configured to reduce thrombus or tissue proliferation.

With continued reference to <FIG>, the one or more connectors <NUM> may facilitate coupling of the first tubular conduit <NUM> to the second tubular conduit <NUM>, or vice versa. In certain embodiments, such as the embodiment shown in <FIG>, the connector <NUM> can be disposed at a central end <NUM> the second tubular conduit <NUM>.

As depicted, the connector <NUM> may include one or more barbs or protrusions <NUM> that are designed to engage with an inner surface of the first tubular conduit <NUM> to form a fluid-tight connection. While <FIG> shows the connector <NUM> at the central end <NUM> of the second tubular conduit <NUM>, a skilled artisan will recognize that, in other embodiments, the connector <NUM> may instead be disposed at a peripheral end <NUM> of the first tubular conduit <NUM>. In still other embodiments, the connector <NUM> may include components disposed at both the central end <NUM> of the second tubular conduit <NUM> and the peripheral end <NUM> of the first tubular conduit <NUM>. The connector <NUM> may be made from any suitable material, such as a metal (e.g., steel or titanium), a polymer, etc..

The vascular access assembly <NUM> may be used in any suitable medical procedure, such methods not forming part of the claimed invention, such as to establish vascular access for hemodialysis. For example, where a vein has become stenotic or otherwise failed an artificial flow path that bypasses the stenosis or failure may be established. Stated another way, an artificial flow path may be established from a target site (e.g., from a target site in a vessel, artery, arteriovenous graft, etc.) to the vena cava or right atrium of the heart. Various examples herein discuss access and therapies performed in the right atrium of the heart. These examples and related disclosure may be analogously applied to access and therapies performed at adjacent locations such as the vena cava or the venous vasculature around the vena cava. Still further, while specific examples and disclosure below may refer to systems disposed within veins of a patient, any of the methods for declotting conduits, closing or sealing conduits, and so forth may be analogously applied to a variety of vessels, including veins, arteries, ducts, vessels, and other locations within the body.

As shown in <FIG>, such a medical procedure may initially involve making a first incision <NUM> at or adjacent to the neck of a patient <NUM> to access the right internal jugular vein of the patient <NUM>. A guidewire may then be passed into the right internal jugular vein to the inferior vena cava, followed by a dilator that is passed over the guidewire to facilitate insertion of an introducer. The dilator may then be removed, and the introducer passed over the guidewire into the right internal jugular vein of the patient <NUM>. Once the introducer is placed within the right internal jugular vein, a central end portion <NUM> of the first tubular conduit <NUM> may be inserted through the introducer and advanced within the patient <NUM> such that the central end portion <NUM> of the first tubular conduit <NUM> passes through the superior vena cava into the right atrium of a heart <NUM> (e.g., the mid to upper right atrium) as depicted in <FIG>. Advancement of the first tubular conduit <NUM> into the patient <NUM> may be done under fluoroscopic guidance.

After the central end portion <NUM> of the first tubular conduit <NUM> has been placed within the right atrium of the heart <NUM>, a second incision <NUM> (see <FIG>) may be made in the shoulder region of the patient <NUM> (e.g., adjacent the deltopectoral groove). A tunneling device may then be used to establish a subcutaneous path between the first incision <NUM> in the neck region of the patient <NUM> and the second incision <NUM> in the shoulder region of the patient <NUM>. The peripheral end <NUM> of the first tubular conduit <NUM> may then be inserted into the first incision <NUM> and advanced along the path established by the tunneling device (i.e., the first tubular conduit <NUM> is tunneled) such that the first tubular conduit <NUM> extends from the right atrium of the heart <NUM> to the second incision <NUM> in the shoulder region of the patient <NUM> as shown in <FIG>.

Once the first tubular conduit <NUM> has been placed such that the first tubular conduit <NUM> extends from the right atrium of the heart <NUM> to the second incision <NUM> in the shoulder region of the patient <NUM>, an incision may be made at a target site <NUM>, for example, in an artery as depicted. In some other embodiments, the target site <NUM> may be in an arteriovenous graft, a vein, or another suitable position. A tunneling device may then be used to establish a subcutaneous path between the second incision <NUM> in the shoulder region of the patient <NUM> to the target site <NUM>. A peripheral end <NUM> of the second tubular conduit <NUM> may then be inserted into the second incision <NUM> and advanced along the path established by the tunneling device (i.e., the second tubular conduit <NUM> is tunneled) such that the second tubular conduit <NUM> extends from the second incision <NUM> in the shoulder region of the patient <NUM> to the target site <NUM> as shown in <FIG>.

With the central end portion <NUM> of the first tubular conduit <NUM> disposed within the right atrium of the heart <NUM> of the patient <NUM>, the peripheral end <NUM> of the first tubular conduit <NUM> may then, if needed, be cut to the appropriate length. In other words, the first tubular conduit <NUM> may initially (e.g., when manufactured and inserted as described above) have a length that is longer than is needed to establish a flow path from the right atrium of the heart <NUM> of the patient <NUM> to the second incision <NUM> in the shoulder region of the patient <NUM>. The first tubular conduit <NUM> may then be cut to proper length to facilitate coupling of the second tubular conduit <NUM> to the first tubular conduit <NUM> at the second incision <NUM> in the shoulder region of the patient <NUM>. As depicted, the central end <NUM> of the second tubular conduit <NUM> may be coupled to the peripheral end <NUM> of the first tubular conduit <NUM> via the connector <NUM>.

Similarly, in some embodiments, the second tubular conduit <NUM> may have an initial length that is longer than is needed to establish a flow path from the second incision <NUM> in the shoulder region of the patient <NUM> to the target site <NUM>. In such embodiments, the central end <NUM> of the second tubular conduit <NUM> may be cut to the appropriate length once the second tubular conduit <NUM> has been inserted into the patient <NUM>. In some embodiments, the connector <NUM> may then be attached to the newly formed central end portion of the second tubular conduit <NUM>. In some other embodiments, no cutting of the second tubular conduit <NUM> may be needed.

Once the first tubular conduit <NUM> and the second tubular conduit <NUM> are the proper length, the second tubular conduit <NUM> may be coupled to the first tubular conduit <NUM>, or vice versa. For example, the connector <NUM> at the central end <NUM> of the second tubular conduit <NUM> may be inserted into the peripheral end <NUM> of the first tubular conduit <NUM> such that the barbs or protrusions <NUM> of the connector <NUM> engage with an inner surface of the first tubular conduit <NUM> (see <FIG>). Such engagement may establish a fluid-tight connection between the first tubular conduit <NUM> and the second tubular conduit <NUM>. Establishment of a fluid-tight connection can be confirmed by attaching the peripheral end <NUM> of the second tubular conduit <NUM> to a syringe and advancing fluid (e.g., heparinized saline) through the system.

The peripheral end <NUM> of the second tubular conduit <NUM> may be coupled to an artery at the target site <NUM>. For example, an incision may be made at the target site <NUM> and an arterial anastomosis may be performed between the peripheral end <NUM> of the second tubular conduit <NUM> and the target site <NUM>. Coupling of a portion of the vascular access assembly <NUM> (e.g., the peripheral end <NUM> of the second tubular conduit <NUM>) to an artery may be performed via any suitable technique. Once a flow path from the target site <NUM> to the heart <NUM> has been established as shown in <FIG>, the first incision <NUM> and the second incision <NUM> may be closed via any suitable technique. In this manner, the vascular access assembly <NUM> may, when implanted and assembled, be a fully subcutaneous surgical implant. Furthermore, the implanted and assembled vascular access assembly <NUM> may, as described above, be implanted without establishing a venous anastomosis.

The implanted vascular access assembly <NUM> may be used to facilitate vascular access. For example, in the case of hemodialysis, a practitioner may insert a first needle through the skin of the patient <NUM> and into the vascular access assembly <NUM>. More particularly, the first needle may be inserted into the second tubular conduit <NUM>. Fluid may be withdrawn from the vascular access assembly <NUM> and drawn into a dialysis machine that purifies the blood. The purified blood may then be returned to the patient <NUM> via a second needle that extends through the skin of the patient <NUM> and into a more central location of the second tubular conduit <NUM>.

The steps of the procedure described above are only exemplary in nature. In other words, the vascular access assembly <NUM> may be implanted into the patient <NUM> via a procedure that deviates somewhat from the procedure described above. One of ordinary skill in the art, having the benefit of this disclosure, will also appreciate that some of the steps described above need not be performed in the order that is specified above.

For reference, methods (not claimed) of accessing an implanted vascular access assembly <NUM> are provided. A practitioner may desire to access the vascular access assembly <NUM> so that the practitioner may clean or clear at least a portion of the vascular access assembly <NUM>. In some embodiments, the vascular access assembly <NUM>, or at least a portion of the vascular access assembly <NUM>, may become occluded and/or blocked during use. For example, a blood clot or other embolus may develop within at least a portion of the vascular access assembly <NUM>. Accordingly, the practitioner may access the vascular access assembly <NUM> to remove the blood clot or other embolus from within the vascular access assembly <NUM>. In an effort to streamline the disclosure, the methods provided herein generally refer to the removal of a blood clot from the vascular access assembly <NUM>. The provided methods (not claimed), however, may also be used and/or adapted for the removal of other types of emboli from within the vascular access assembly <NUM> (e.g., fatty deposits, tissue growths, etc.).

<FIG> depicts a catheter <NUM> that has been inserted into an internal jugular vein <NUM> of the patient <NUM>. The catheter <NUM> is the declotting catheter of the vascular access assembly declotting system according to the invention. As shown, a vascular access assembly <NUM> is disposed in the patient <NUM>. A practitioner may make an incision or a third incision <NUM> at or adjacent a neck of the patient <NUM>. The practitioner may then dispose at least a portion of the catheter <NUM> through the incision <NUM> and into at least a portion of the jugular vein <NUM>.

The practitioner may then displace the catheter <NUM> through at least a portion of the vasculature of the patient <NUM> such that a central end portion <NUM> of the catheter <NUM> is displaced through the jugular vein, a brachiocephalic vein, and/or a superior vena cava, and into at least a portion of the right atrium <NUM> of the heart <NUM>. As illustrated in <FIG>, the practitioner may displace the catheter <NUM> through the right internal jugular vein <NUM>, the right brachiocephalic vein <NUM>, and the superior vena cava <NUM>, and into at least a portion of the right atrium <NUM> of the heart <NUM>.

In some other embodiments, the practitioner may displace the catheter <NUM> from the left lateral side of the patient <NUM>, for example, through the left internal jugular vein, the left brachiocephalic vein, the superior vena cava <NUM>, and into at least a portion of the right atrium <NUM> of the heart <NUM>. Due to the disposition of the first tubular conduit <NUM> within at least a portion of the vasculature on the right lateral side of the patient <NUM> (e.g., within the right brachiocephalic vein <NUM>), access to the right atrium <NUM> for the catheter <NUM> may be less obstructed from the left lateral side of the patient <NUM>. For example, an inside diameter of the right brachiocephalic vein <NUM> may be too narrow or small for passage of two elongate medical devices (e.g., the first tubular conduit <NUM> and the catheter <NUM>). Accordingly, access to the right atrium <NUM> from the left lateral side of the patient <NUM> may avoid interactions or obstructions between the catheter <NUM> and the first tubular conduit <NUM> along at least a portion of a path of the catheter <NUM> through the vasculature to the right atrium <NUM>.

Upon disposition of the central end portion <NUM> of the catheter <NUM> within the right atrium <NUM>, the catheter <NUM> may be coupled to the first tubular conduit <NUM> as shown in <FIG>. In some embodiments, the central end portion <NUM> of the catheter <NUM> may be coupled to the central end portion <NUM> of the first tubular conduit <NUM>.

With reference to <FIG>, methods (not claimed) of declotting or removing a clot from the vascular access assembly <NUM> within the patient <NUM> may include inserting the central end portion <NUM> of the catheter <NUM> into the patient <NUM>. The central end portion <NUM> of the catheter <NUM> may be displaced through at least a portion of the vasculature of the patient <NUM> such that the central end portion <NUM> of the catheter <NUM> is disposed within the right atrium <NUM> of the heart <NUM> of the patient <NUM>. In certain embodiments, the central end portion <NUM> of the catheter <NUM> may be disposed within the right atrium <NUM> via the internal jugular vein <NUM> (e.g., the right internal jugular vein) as depicted in <FIG>. In certain other embodiments, such methods not forming part of the claimed invention, the central end portion <NUM> of the catheter <NUM> may be disposed within the right atrium <NUM> via a femoral vein <NUM> (e.g., the right femoral vein) as described below (see, e.g., <FIG>).

Methods (not claimed) of declotting the vascular access assembly <NUM> may include coupling at least a portion of the central end portion <NUM> of the catheter <NUM> to at least a portion of a central end portion of the vascular access assembly <NUM> (e.g., the central end portion <NUM> of the first tubular conduit <NUM>). The central end portion <NUM> of the catheter <NUM> may be coupled to the central end portion of the vascular access assembly <NUM> within the right atrium <NUM> (see, e.g., <FIG>).

Methods (not claimed) of declotting the vascular access assembly <NUM> may include evacuating a clot from within a portion of the vascular access assembly <NUM>. The clot may be evacuated from within the portion of the vascular access assembly <NUM> via at least a portion of the catheter <NUM> (e.g., via a lumen <NUM> of the catheter <NUM>). The methods may include applying a suction force on the catheter <NUM> (e.g., on the lumen <NUM> of the catheter <NUM>) such that at least a portion of the suction force may be applied on the vascular access assembly <NUM> (e.g., on a lumen of the first tubular conduit <NUM>) to evacuate the clot. For example, a vacuum source may be coupled to or placed in fluid communication with a peripheral end of the catheter <NUM>. In some embodiments, the vacuum source may be a component of the vascular access assembly declotting system. The vacuum source may be activated (e.g., by the practitioner) such that the suction force is applied on the catheter <NUM> and/or the vascular access assembly <NUM>. Other methods of applying a suction force on the clot via the catheter <NUM> are also within the scope of this disclosure.

Methods (not claimed) of declotting the vascular access assembly <NUM> may further include flushing (e.g., with a fluid such as a saline solution) a portion of the vascular access assembly <NUM>. The flushing may act to displace or loosen the clot or at least a portion of the clot such that the clot may be displaced from within the vascular access assembly <NUM> to the lumen <NUM> of the catheter <NUM>.

Methods (not claimed) of declotting the vascular access assembly <NUM> may also include displacing the clot or at least a portion of the clot from within the vascular access assembly <NUM> to the lumen <NUM> of the catheter <NUM> and grinding or macerating at least a portion of the clot (e.g., with a macerator) as the clot is displaced from within the vascular access assembly <NUM> to the lumen <NUM> of the catheter <NUM>. Grinding or macerating of the clot may aid or ease displacement of the clot through the lumen <NUM> of the catheter <NUM>. Embodiments of catheters including a macerator are discussed in further detail below in reference to <FIG>.

<FIG> depicts the central end portion <NUM> of the catheter <NUM> and the central end portion <NUM> of the first tubular conduit <NUM> in a decoupled configuration and <FIG> depicts the central end portion <NUM> of the catheter <NUM> and the central end portion <NUM> of the first tubular conduit <NUM> in a coupled configuration. As illustrated, at least a portion of the central end portion <NUM> of the catheter <NUM> may be funnel shaped. The funnel shape may aid in the coupling of the catheter <NUM> to the first tubular conduit <NUM>. For example, an inside surface of the funnel-shaped central end portion <NUM> may guide the central end portion <NUM> of the first tubular conduit <NUM> into at least a portion of the catheter <NUM> such that the first tubular conduit <NUM> and the catheter <NUM> may be coupled to each other.

With reference to <FIG>, an internal diameter D<NUM> of at least a portion of the central end portion <NUM> of the catheter <NUM> can be greater than an external diameter D<NUM> of at least a portion of the central end portion <NUM> of the first tubular conduit <NUM>. Accordingly, at least a portion of the central end portion <NUM> of the catheter <NUM> may be displaceable around at least a portion of the central end portion <NUM> of the first tubular conduit <NUM>. In various embodiments, the coupling of the central end portion <NUM> of the catheter <NUM> to the central end portion <NUM> of the first tubular conduit <NUM> can form a substantially fluid-tight seal. For example, the catheter <NUM> may be coupled to the first tubular conduit <NUM> such that the contents of the catheter <NUM> and/or the first tubular conduit <NUM> (e.g., a portion of a clot) do not leak into the right atrium <NUM>.

As shown in <FIG>, at least a portion of the central end portion <NUM> of the catheter <NUM> may be substantially J shaped. In some embodiments, the central end portion <NUM> of the catheter <NUM> may have a low-profile state and a deployed state. The low-profile state may be substantially linear such that the central end portion <NUM> of the catheter <NUM> may be displaced through the vasculature of the patient <NUM> more easily and/or such that the central end portion <NUM> of the catheter <NUM> is atraumatic. For example, when in the low-profile state, the central end portion <NUM> of the catheter <NUM> may be configured to avoid or limit damaging the vasculature. The deployed state may be substantially J shaped. For example, upon disposition of the central end portion <NUM> of the catheter <NUM> within the atrium, the central end portion <NUM> may transition between the low-profile state (e.g., a low-profile configuration) and the deployed state (e.g., the J-shaped configuration).

In certain embodiments, the practitioner may actuate the catheter <NUM> such that the central end portion <NUM> of the catheter <NUM> transitions from the low-profile state to the deployed state. For example, the practitioner may pull on a wire that results in bending or curving of at least a portion of the central end portion <NUM>. When in the deployed state, the central end portion <NUM> may be configured to be displaced over and/or around at least a portion of the central end portion <NUM> of the first tubular conduit <NUM> such that the catheter <NUM> may be coupled to the first tubular conduit <NUM>. For example, the practitioner may displace the catheter <NUM> peripherally relative to the heart <NUM> and dispose the central end portion <NUM> of the catheter <NUM> around and/or over at least a portion of the central end portion <NUM> of the first tubular conduit <NUM>.

In various embodiments, the central end portion <NUM> of the catheter <NUM> may include a purse string mechanism or an iris mechanism (not shown). The purse string mechanism may be disposed at or adjacent a central end of the central end portion <NUM> of the catheter <NUM>. The purse string mechanism may include a suture or wire that is disposed around a circumference of the central end portion <NUM> of the catheter <NUM>. The purse string mechanism may be configured to transition the central end portion <NUM> of the catheter <NUM> between an open state and a closed state. When in the closed state, the central end portion <NUM> of the catheter <NUM> may be configured to form a seal between an inside surface of at least a portion of the central end portion <NUM> of the catheter <NUM> and at least a portion of an outside surface of the central end portion <NUM> of the first tubular conduit <NUM>.

As discussed above, the vascular access assembly <NUM> forming part of the vascular access device declotting system according to the invention includes a first tubular conduit <NUM> having a central end portion <NUM> for disposal within the heart <NUM> of the patient <NUM>. The vascular access assembly <NUM> further includes a second tubular conduit <NUM> having a peripheral end <NUM> coupled to a vessel of the patient <NUM>. Furthermore, a peripheral end <NUM> of the first tubular conduit <NUM> is releasably coupled ( by an adaptor <NUM>, as a connector <NUM>), to a central end <NUM> of the second tubular conduit <NUM>. Accordingly, a flow path can extend from the vessel to the heart <NUM> via the first and second tubular conduits <NUM>, <NUM>. The flow path may extend from a brachial artery or an arteriovenous graft to the right atrium <NUM>.

Methods (not claimed) of declotting the vascular access assembly <NUM> may further include decoupling the first tubular conduit <NUM> and the second tubular conduit <NUM>, for example, at the adaptor <NUM>. The practitioner may then couple a flushing mechanism (not shown) to the peripheral end <NUM> of the first tubular conduit <NUM>. The flushing mechanism may be a component of the vascular access assembly declotting system. In certain embodiments, the flushing mechanism may include a flushing catheter, wherein a peripheral end portion of the flushing catheter is in fluid communication with a fluid source (e.g., a source of a saline solution or another suitable fluid). Upon coupling of the flushing mechanism and the first tubular conduit <NUM>, the practitioner may displace a fluid through at least a portion of the flushing mechanism and through at least a portion of the first tubular conduit <NUM>. Stated another way, the practitioner may flush the first tubular conduit <NUM> such that a clot is displaced from within the first tubular conduit <NUM> to the lumen <NUM> of the catheter <NUM>.

Methods (not claimed) of declotting or removing a clot from the vascular access assembly <NUM> within the patient <NUM> can include: accessing a jugular vein of the patient <NUM>, inserting the central end portion <NUM> of the catheter <NUM> into the jugular vein, displacing the catheter <NUM> such that the central end portion <NUM> of the catheter <NUM> is disposed within the right atrium <NUM> of the heart <NUM> of the patient <NUM>, coupling the central end portion <NUM> of the catheter <NUM> to the central end portion <NUM> of the vascular access assembly <NUM> disposed within the right atrium <NUM>, and/or evacuating the clot from within a portion of the vascular access assembly <NUM> via the catheter <NUM>. The methods (not claimed) may further include evacuating or sucking the clot from within at least a portion of the vascular access assembly <NUM> and through the catheter <NUM> to evacuate the clot from within the vascular access assembly <NUM>.

Displacing the catheter <NUM> such that the central end portion <NUM> of the catheter <NUM> is disposed within the right atrium <NUM> may further include displacing the central end portion <NUM> of the catheter <NUM> through at least a portion of each of the right internal jugular vein <NUM>, the right brachiocephalic vein <NUM>, and/or the superior vena cava <NUM> of the patient <NUM>. Other methods of accessing the right atrium <NUM> are also within the scope of this disclosure (e.g., via the vasculature of the left lateral side of the patient <NUM> as discussed above or via a femoral vein as described in further detail below).

<FIG> depicts a central end portion <NUM>' of a first tubular conduit <NUM>'. As shown, the central end portion <NUM>' of the first tubular conduit <NUM>' may include a purse string mechanism <NUM>' or an iris mechanism. The purse string mechanism <NUM>' may be disposed at or adjacent a central end of the central end portion <NUM>' of the first tubular conduit <NUM>'. Analogous to the discussion above, the purse string mechanism <NUM>' may include a suture or wire that is disposed around a circumference of the central end portion <NUM>' of the first tubular conduit <NUM>'. The purse string mechanism <NUM>' may be configured to transition the central end portion <NUM>' of the first tubular conduit <NUM>' between an open state and a closed state. When in the closed state, the central end portion <NUM>' of the first tubular conduit <NUM>' may be configured to form a seal at or adjacent the central end portion <NUM>' of the first tubular conduit <NUM>'.

In some embodiments, the purse string mechanism <NUM>' may be utilized to close the central end portion <NUM>' of the first tubular conduit <NUM>' prior to removal of the first tubular conduit <NUM>'. For instance, a practitioner may desire to remove and replace a tubular conduit from an implanted assembly, due to clotting of that conduit, for example. Use of a purse string, such as purse string mechanism <NUM>' may prevent a clot from exiting the conduit while that conduit is being removed. Thus, in some instances, a practitioner may close the end of the conduit via a purse string or other mechanism, prior to removing the conduit from the patient's body. A replacement conduit may then be introduced to replace the withdrawn conduit.

Methods (not claimed) of declotting a vascular access assembly may include decoupling the first tubular conduit <NUM>' and a second tubular conduit (e.g., at an adaptor) and the method may utilize a vacuum. The practitioner may then couple a vacuum source to a peripheral end of the first tubular conduit <NUM>'. In certain embodiments, the vacuum source may be coupled to the first tubular conduit <NUM>' via a vacuum catheter. The practitioner may also transition the central end portion <NUM>' of the first tubular conduit <NUM>' to the closed state, for example, by actuating the purse string mechanism <NUM>'. In some embodiments, the vacuum source and/or the vacuum catheter may be components of the vascular access assembly declotting system.

The vacuum source may be activated (e.g., by the practitioner) such that a suction force is applied on the first tubular conduit <NUM>' and a clot disposed within the first tubular conduit <NUM>' can be displaced from within, evacuated from, or sucked out of the first tubular conduit <NUM>'. Disposition of the purse string mechanism <NUM>' and/or the central end portion <NUM>' of the first tubular conduit <NUM>' in the closed state may limit or prevent the clot, or a portion of the clot, from exiting the first tubular conduit <NUM>' at the central end portion <NUM>'. Accordingly, the clot may be limited or prevented from entering or being lost into the vena cava and/or the heart of the patient.

<FIG> depict an embodiment of a vascular access assembly <NUM> that resembles the vascular access assembly <NUM> described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to "<NUM>. " For example, the embodiment depicted in <FIG> includes a first tubular conduit <NUM> that may, in some respects, resemble the first tubular conduit <NUM> of <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the vascular access assembly <NUM> and related components shown in <FIG>may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the vascular access assembly <NUM> and related components depicted in <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the vascular access assembly <NUM> and related components illustrated in <FIG> can be employed with the vascular access assembly <NUM> and related components of <FIG>, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

<FIG> depicts a catheter <NUM> that has been inserted into a femoral vein <NUM> of the patient <NUM>. As shown, a vascular access assembly <NUM> is disposed in the patient <NUM>. A practitioner may make an incision or a fourth incision <NUM> at or adjacent a thigh or an upper leg of the patient <NUM>. The practitioner may then dispose at least a portion of the catheter <NUM> through the incision <NUM> and into at least a portion of the femoral vein <NUM>.

The practitioner may then displace the catheter <NUM> through at least a portion of the vasculature of the patient <NUM> such that a central end portion <NUM> of the catheter <NUM> is displaced through a femoral vein, an external iliac vein, a common iliac vein, and/or an inferior vena cava, and into at least a portion of the right atrium <NUM> of the heart <NUM>. As discuss above in reference to jugular access, femoral access may also be performed through either the right lateral side or the left lateral side of the patient <NUM>. As illustrated in <FIG>, the practitioner may displace the catheter <NUM> through the right femoral vein <NUM>, the right external iliac vein <NUM>, the right common iliac vein <NUM>, and the inferior vena cava <NUM>, and into at least a portion of the right atrium <NUM> of the heart <NUM>.

Upon disposition of the central end portion <NUM> of the catheter <NUM> within the right atrium <NUM>, the catheter <NUM> may be coupled to the first tubular conduit <NUM> as shown in <FIG>. In some embodiments, the central end portion <NUM> of the catheter <NUM> may be coupled to a central end portion <NUM> of the first tubular conduit <NUM>.

Methods (not claimed) of declotting the vascular access assembly <NUM> may include coupling at least a portion of the central end portion <NUM> of the catheter <NUM> to at least a portion of a central end portion of the vascular access assembly <NUM> (i.e., the central end portion <NUM> of the first tubular conduit <NUM>). The central end portion <NUM> of the catheter <NUM> may be coupled to the central end portion of the vascular access assembly <NUM> within the right atrium <NUM> (see, e.g., <FIG>).

Methods (not claimed) of declotting the vascular access assembly <NUM> may include evacuating a clot from within a portion of the vascular access assembly <NUM>. The clot may be evacuated from within the portion of the vascular access assembly <NUM> via at least a portion of the catheter <NUM> (e.g., via a lumen <NUM> of the catheter <NUM>). As discussed above in reference to catheter <NUM>, the methods may include applying a suction force on the catheter <NUM> such that at least a portion of the suction force may be applied on the vascular access assembly <NUM> (e.g., on a lumen of the first tubular conduit <NUM>) to evacuate the clot. Furthermore, methods of declotting the vascular access assembly <NUM> may also include flushing (e.g., with a fluid such as a saline solution) a portion of the vascular access assembly <NUM>.

<FIG> depicts the central end portion <NUM> of the catheter <NUM> and the central end portion <NUM> of the first tubular conduit <NUM> in a decoupled configuration and <FIG> depicts the central end portion <NUM> of the catheter <NUM> and the central end portion <NUM> of the first tubular conduit <NUM> in a coupled configuration. With reference to <FIG>, an internal diameter D<NUM> of at least a portion of the central end portion <NUM> of the catheter <NUM> can be greater than an external diameter D<NUM> of at least a portion the central end portion <NUM> of the first tubular conduit <NUM> (e.g., the central end portion of the vascular access assembly <NUM>). Accordingly, with reference to <FIG>, at least a portion of the central end portion <NUM> of the catheter <NUM> may be displaceable around at least a portion of the central end portion <NUM> of the first tubular conduit <NUM>.

As shown in <FIG>, at least a portion of the central end portion <NUM> of the catheter <NUM> may be substantially linear. The practitioner may displace the catheter <NUM> centrally relative to the heart <NUM> and dispose the central end portion <NUM> of the catheter <NUM> around and/or over at least a portion of the central end portion <NUM> of the first tubular conduit <NUM> (e.g., to form a seal between the catheter <NUM> and the first tubular conduit <NUM>). Other embodiments of the catheter <NUM> and/or the central end portion <NUM> of the catheter <NUM>, as disclosed herein, may be used in methods of femoral vein access to the right atrium <NUM>. For example, the catheter <NUM> may include a purse string mechanism, as described above, such that the catheter <NUM> may form a seal between an inside surface of at least a portion of the central end portion <NUM> of the catheter <NUM> and at least a portion of an outside surface of the central end portion <NUM> of the first tubular conduit <NUM> when in the closed state.

Methods (not claimed) of declotting or removing a clot from the vascular access assembly <NUM> within the patient <NUM> can include: accessing the femoral vein <NUM> of the patient <NUM>, inserting the central end portion <NUM> of the catheter <NUM> into at least a portion of the femoral vein <NUM>, displacing the catheter <NUM> such that the central end portion <NUM> of the catheter <NUM> is disposed within the right atrium <NUM> of the heart <NUM> of the patient <NUM>, coupling the central end portion <NUM> of the catheter <NUM> to the central end portion <NUM> of the first tubular conduit <NUM> (i.e., the central end portion of the vascular access assembly <NUM>) disposed within the right atrium <NUM>, and/or evacuating the clot from within a portion of the vascular access assembly <NUM> via the catheter <NUM>. The methods may further include sucking the clot (e.g., using a vacuum mechanism) from within the vascular access assembly <NUM> and through the catheter <NUM> to evacuate the clot from within the vascular access assembly <NUM>.

Displacing the catheter <NUM> such that the central end portion <NUM> of the catheter <NUM> is disposed within at least a portion of the right atrium <NUM> may include displacing the central end portion <NUM> of the catheter <NUM> through each of the femoral vein <NUM>, the external iliac vein <NUM>, the common iliac vein <NUM>, and/or the inferior vena cava <NUM> of the patient <NUM>. As discussed above, other methods of accessing the right atrium <NUM> are also within the scope of this disclosure.

<FIG> illustrates a central end portion <NUM> of a catheter <NUM>. The central end portion <NUM> of the catheter <NUM> may be funnel shaped. Furthermore, the catheter <NUM> can include a macerator <NUM> coupled to or disposed within at least a portion of the catheter <NUM>. As depicted, at least a portion of the macerator <NUM> may be disposed at or adjacent the central end portion <NUM> of the catheter <NUM>. As discussed above, a practitioner may actuate the macerator <NUM> such that the macerator <NUM> may grind or macerate a clot as the clot passes from within the vascular access assembly to the catheter <NUM> or a lumen <NUM> of the catheter <NUM>. The grinding or macerating of the clot may aid or ease displacement of the clot through the catheter <NUM> or the lumen <NUM> of the catheter <NUM>.

In another method (not claimed) of declotting a conduit, a practitioner may advance a balloon through a clotted conduit from a peripheral position toward a central position. For example, with reference to the embodiment of <FIG>, in some instances a clot may be disposed in a portion of the vascular access assembly <NUM>, such as within the first tubular conduit <NUM>. A practitioner may decouple the peripheral end <NUM> of the first tubular conduit <NUM> and advance a low-profile balloon through the first tubular conduit <NUM> toward the central end portion <NUM> of the first tubular conduit <NUM>. The balloon may be advanced in a low-profile, deflated configuration and may traverse the clot without displacing the clot in the central direction. The balloon may then be inflated and withdrawn in the peripheral direction. The inflated balloon may then be used to pull the clot in the peripheral direction and out of the peripheral end <NUM> of the first tubular conduit <NUM>. Methods utilizing balloons may be utilized in any of the systems, and any of the locations within the body, described herein in connection with other embodiments or examples.

Any methods (none of which are claimed) disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another.

Claim 1:
A vascular access device declotting system, comprising:
a vascular access assembly (<NUM>), comprising:
a first tubular conduit (<NUM>) comprising a first central end portion (<NUM>) for disposal within a heart of a patient,
a second tubular conduit (<NUM>) for being coupled to a vessel, and
at least one connector (<NUM>) coupled to the first tubular conduit (<NUM>) and the second tubular conduit (<NUM>) such that a flow path extends via the first tubular conduit and the second tubular conduit; and
a declotting catheter (<NUM>) comprising a second central end portion,
wherein the first central end portion (<NUM>) of the first tubular conduit (<NUM>) is configured to couple with the second central end portion (<NUM>) of the declotting catheter (<NUM>), and
wherein the system is configured such that the coupling of the first central end portion (<NUM>) to the first tubular conduit (<NUM>) with second central end portion (<NUM>) of the declotting catheter (<NUM>) is configured to be carried out in the vasculature of the patient.