Patent Description:
There are several approaches to treatment for hypervolemia. One of the most common treatments for hypervolemia is diuretics. Diuretics are drugs that increase the amount of urine the body produces. Increased urination in turn reduces the fluid overload. However, some patients do not respond adequately to diuretic therapy. There is some evidence that by temporarily reducing blood flow to the heart, the symptoms of fluid overload can be improved, leading to increased diuretic efficiency and further improvement to patient's condition. <CIT> is concerned with a device for treating venous incompetence and related methods. <CIT> is concerned with an embolic implant and method of use.

The invention is defined in the independent claim and additional embodiments are defined in the dependent claims. Embodiments disclosed herein are directed to a vessel reshaping device for temporarily limiting blood flow to heart. The vessel reshaping device can provide a simpler construction, have a lower profile, and does not require any membrane to reduce blood flow. Advantageously, the vessel reshaping device mitigates the risk of thrombosis as the low profile frame is less likely to thrombose compared to the membrane, and there is no risk of the membrane detaching or causing thrombosis during delivery, use, or retraction of the device.

The vessel reshaping device generally consists of a frame that can temporarily reshape a vessel, e.g. the inferior vena cava ("IVC") in a single axis extending perpendicular to a direction of flow, thereby reducing the cross-sectional area and blood flow through the vessel. The greater the expansion of the reshaping device, the greater the reduction in cross-sectional area and the reduction in flow. For example, expanding a transverse axis of a substantially circular vessel by <NUM>% can reduce the cross-sectional area of the vessel by substantially <NUM>%. As used herein, the longitudinal axis extends substantially parallel to a direction of flow through the vessel. To note, the vessel reshaping device may not significantly stretch the vessel wall, and instead mainly reshapes the vessel wall, however some stretching may occur.

Disclosed herein is a blood flow regulating device for a vessel including, a delivery catheter extending along a longitudinal axis, and a vessel shaping device having a retracted configuration in the delivery catheter and an expanded configuration out of the delivery catheter, the vessel shaping device being arranged to expand to the expanded configuration along a transverse axis perpendicular to the longitudinal axis of the delivery catheter to reshape the vessel to a flattened configuration.

In some embodiments, the flattened configuration of the vessel defines an extended transverse diameter, a reduced lateral diameter, and a smaller cross-sectional area than the cross-sectional area of the vessel in a resting configuration. The vessel shaping device is formed from Nitinol. The vessel shaping device comprises a frame including a first arm extending transversely outward from a central longitudinal axis to define a first apex, and a second arm extending transversely outward from a central longitudinal axis in an opposite direction from the first arm to define a second apex, a proximal end of the first arm and a proximal end of the second arm are coupled to a proximal collar, and a distal end of the first arm and a distal end of the second arm are coupled to a distal collar.

In some embodiments, the vessel shaping device further comprises a tubular member coupled to the frame. In some embodiments, the tubular member is fixedly attached to a distal collar and slidably engaged with the proximal collar, the distal collar defining an atraumatic tip. In some embodiments, the tubular member is slidably engaged with a distal collar and fixedly attached to the proximal collar, a distal end of the tubular member defining an atraumatic tip. In some embodiments, movement of the tubular member or an actuator rod in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis. The vessel shaping device further comprises a first stability member extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm, and a second stability member extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm. The first stability member or the second stability member extends transversely inward towards the central longitudinal axis.

Also disclosed is a vessel shaping device including, a tubular member extending along a longitudinal axis, and a frame coupled to a distal end of the tubular member, the frame including, a first hinged arm including a first proximal member hingedly coupled to a first distal member to define a first apex, the first proximal member coupled to a proximal collar and the first distal member coupled to a distal collar, and a second hinged arm including a second proximal member hingedly coupled to a second distal member to define a second apex, the second proximal member coupled to the proximal collar and the second distal member coupled to the distal collar.

In some embodiments, one of the proximal collar or the distal collar is threadably engaged with the tubular member. The proximal collar is threadably engaged with one of a right-hand thread or a left-hand thread and the distal collar is threadably engaged with one of a left-hand thread or a right-hand thread. Rotation of the tubular member extends the first apex and the second apex away from a longitudinal axis along the transverse axis to transition the vessel shaping device to the expanded configuration. In some embodiments, the vessel shaping device further includes a first apex member extending substantially parallel to the longitudinal axis and hingedly coupled to the first proximal member and the first distal member, and a second apex member extending substantially parallel to the longitudinal axis and hingedly coupled to the second proximal member and the second distal member. In some embodiments, the vessel shaping device further includes a biasing member disposed between the proximal collar and the distal collar and configured to bias the vessel shaping device towards a retracted configuration. In some embodiments, the vessel shaping device further includes a locking mechanism configured to releasably lock a proximal collar or a distal collar relative to the tubular member to inhibit longitudinal movement thereof.

Also disclosed is a method of regulating blood flow in a vessel including, inserting a delivery catheter into the vessel, moving a vessel shaping device out of a distal end of the delivery catheter, and expanding the vessel shaping device from a retracted configuration to an expanded configuration along a transverse axis perpendicular to a longitudinal axis of the delivery catheter to reshape the vessel from a resting configuration to a flattened configuration.

In some embodiments, the method further includes advancing a tubular member distally relative to the deliver catheter to transition the vessel shaping device to the expanded configuration. In some embodiments, the method further includes withdrawing a tubular member proximally relative to the deliver catheter, after moving the vessel shaping device out of a distal end of the delivery catheter, to transition the vessel shaping device to the expanded configuration. In some embodiments, the method further includes rotating a tubular member relative to the deliver catheter to transition the vessel shaping device to the expanded configuration. In some embodiments, the method further includes distally advancing an actuator rod relative to a tubular member to transition the vessel shaping device to the expanded configuration. In some embodiments, the method further includes locking the vessel shaping device in the expanded configuration. In some embodiments, the method further includes selectively detaching the vessel shaping device from the tubular member. In an embodiment, a portion of the vessel shaping device includes a radiopaque marker.

With respect to "proximal," a "proximal portion" or a "proximal end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a "proximal length" of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A "proximal end" of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to "distal," a "distal portion" or a "distal end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a "distal length" of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A "distal end" of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

As used herein, and as shown in <FIG>, a longitudinal axis extends along an axial length of a catheter, substantially parallel to a direction of flow through a vessel, a lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and the lateral axes.

<FIG> show an embodiment of a vessel shaping device <NUM> in accordance with embodiments disclosed herein. The vessel shaping device <NUM> can be disposed at a distal end of a tubular member <NUM>, e.g. stylet, hypotube, or similar elongate medical device configured to extend along the longitudinal axis, through a lumen <NUM> of a delivery catheter ("catheter") <NUM>. The catheter <NUM> can include an introducer, catheter, or similar device configured to deliver the vessel shaping device <NUM> to a target location within a vasculature of the patient. In an embodiment, the tubular member <NUM> can define a lumen <NUM> configured to receive a guidewire, actuator rod, or similar elongate device therethrough.

The vessel shaping device <NUM> can include a frame <NUM> extending from the tubular member <NUM> along an axis that extends perpendicular to the longitudinal axis, for example the transverse axis, lateral axis, or combinations thereof. For ease of explanation, embodiments disclosed herein are described as expanding along the transverse axis, however, this is not intended to be limiting and embodiments can expand along the lateral axis or at an angle relative to one of the transverse or lateral axes.

The frame <NUM> can include a first arm <NUM> extending in a first direction from the tubular member <NUM> and defining a first apex <NUM>. The frame <NUM> can include a second arm <NUM> extending in a second direction, opposite the first direction, from the tubular member <NUM> and defining a second apex <NUM>.

In an embodiment, one of a proximal end or a distal end of the first arm <NUM> can be formed integrally with the tubular member <NUM>. In an embodiment, one of the proximal end or the distal end of the first arm <NUM> can be slidably engaged with the tubular member <NUM>. In an embodiment, one of a proximal end or a distal end of the first arm <NUM> can be coupled with a collar that can be coupled with the tubular member <NUM> in either a fixed relationship or can be slidably engaged with the tubular member <NUM>. For example, the proximal end of the first arm <NUM> can be coupled with a proximal collar <NUM> and a distal end of the first arm <NUM> can be coupled to a distal collar <NUM>. In an embodiment, the distal collar <NUM> can define an atraumatic tip. In an embodiment, a portion of the frame <NUM> can include a radiopaque or acoustically opaque material to facilitate viewing the frame under imaging, e.g. X-ray, fluoroscopy, ultrasound, MRI, etc. In an embodiment, one of the proximal collar <NUM>, distal collar <NUM>, first arm <NUM>, second arm <NUM>, first apex <NUM>, second apex <NUM>, portion thereof, or combinations thereof, can include a radiopaque or acoustically opaque material to identify an outer perimeter of the frame <NUM> under imaging and facilitate correct positioning of the frame <NUM> within the vessel <NUM>.

In an embodiment, one of a proximal end or a distal end of the second arm <NUM> can be formed integrally with the tubular member <NUM>. In an embodiment, one of the proximal end or the distal end of the second arm <NUM> can be slidably engaged with the tubular member <NUM>. In an embodiment, one of a proximal end or a distal end of the second arm <NUM> can be coupled with a collar that can be coupled with the tubular member <NUM> in either a fixed relationship or can be slidably engaged with the tubular member <NUM>. For example, the proximal end of the second arm <NUM> can be coupled with the proximal collar <NUM> and a distal end of the second arm <NUM> can be coupled to the distal collar <NUM>.

In an embodiment, one of the first arm <NUM> or the second arm <NUM> can include a stability member. For example, the first arm <NUM> can include a first stability member <NUM> extending across the first apex <NUM> between a proximal portion and a distal portion of the first arm <NUM>. The first stability member <NUM> can extend transversely inward, toward a central longitudinal axis. The first stability member <NUM> can further support the elastic deformation of first arm <NUM>, as described in more detail herein. Similarly, the second arm <NUM> can include a second stability member <NUM> extending across the second apex <NUM> between a proximal portion and a distal portion of the second arm <NUM>. The second stability member <NUM> can extend transversely inward, toward a central longitudinal axis. The second stability member <NUM> can further support the elastic deformation of second arm <NUM>, as described in more detail herein.

In an embodiment, the first arm <NUM> and the second arm <NUM> of the frame <NUM> can elastically deform between a retracted configuration (e.g. <FIG>) and an extended configuration (e.g. <FIG>).

In an embodiment, the vessel shaping device <NUM> can be biased towards the retracted configuration, such that at rest the vessel shaping device <NUM> defines a first transverse distance (d1) between the first apex <NUM> and the second apex <NUM>. In an embodiment, the first transverse distance (d1) can be greater than a diameter (d3) of the catheter lumen <NUM>. In an embodiment, the first transverse distance (d1) can be less than a diameter (d3) of the catheter lumen <NUM>. In an embodiment, the vessel shaping device <NUM> can be biased towards the extended configuration, such that at rest the vessel shaping device <NUM> defines a second distance (d2) between the first apex <NUM> and the second apex <NUM>, which is greater than the first distance (d1). In an embodiment, the vessel shaping device <NUM> in the retracted configuration defines a transverse distance (d1) that is greater than a diameter (d3) of the catheter lumen <NUM>. The vessel shaping device <NUM> can elastically deform to a compact configuration (not shown) where a transverse distance between the first apex <NUM> and the second apex <NUM> is less than a diameter (d3) of the catheter lumen <NUM>.

As shown in <FIG>, in the retracted configuration, the distance (d1) between the first apex <NUM> and the second apex <NUM> can be equal to, or less than, a diameter of the vessel <NUM> in a resting position. To note, the vessel <NUM> in the resting position can define a circular or slightly oval cross-sectional shape. As shown in <FIG>, in the extended configuration, the distance (d2) between the first apex <NUM> and the second apex <NUM> can be greater than a resting diameter of the vessel <NUM> at a target location. As such, the diameter of the vessel <NUM> can be reshaped along a first axis, e.g. a transverse axis, to a flattened configuration. As such, in the flattened configuration a second axis of the vessel <NUM>, e.g. a lateral axis, is reduced. Further, a cross-section area of the vessel <NUM> in the flattened configuration, e.g. <FIG>, can be less than a cross-section area of the vessel <NUM> in a resting configuration, e.g. <FIG>. For example, a substantially circular vessel <NUM> in a resting configuration can be reshaped to a flattened configuration by extending the transverse axis by <NUM>%. In such a flattened configuration, a cross-sectional area of the vessel can be reduced by <NUM>%. However, it will be appreciated that greater or lesser ratios of reshaping to cross-sectional area reduction are also contemplated.

In an exemplary method of use, a vessel shaping device <NUM> can be provided as described herein. The vessel shaping device <NUM> can be disposed within a lumen <NUM> of the delivery catheter <NUM> and advanced to a target location within the vasculature of the patient. Once proximate the target location, the tubular member <NUM> can be urged distally to advance the vessel shaping device <NUM> distally of the distal tip <NUM> of the catheter <NUM>. The vessel shaping device <NUM> can then transition to the extended configuration to define a transverse distance (d2) between the first apex <NUM> and the second apex <NUM> and reshape the vessel <NUM> from a resting configuration to a flattened configuration and reduce the cross-sectional area of the vessel <NUM>.

In an embodiment, the vessel shaping device <NUM> can be biased towards the extended configuration and can be elastically deformed to a retracted configuration to fit within the lumen <NUM> of the catheter <NUM>. As such, when the vessel shaping device <NUM> is advanced distally of the distal tip <NUM> of the catheter <NUM>, the device <NUM> can expand to an expanded configuration and transition the vessel to the flattened configuration.

In an embodiment, the vessel shaping device <NUM> can be biased towards the retracted configuration that defines a transvers distance (d1). As such, when the vessel shaping device <NUM> is advanced distally of the distal tip <NUM> of the catheter <NUM>, a handle coupled to a proximal end of the tubular member <NUM> can be actuated to transition the device <NUM> to the expanded configuration. In an embodiment, the tubular member <NUM> can include an actuator, operatively coupled to one of the proximal collar <NUM> or the distal collar <NUM> to selectively transition the vessel shaping device <NUM> between the retracted configuration and the extended configuration. For example, an actuator rod can extend through a lumen <NUM> the tubular member <NUM> to the distal collar <NUM>. Withdrawing the actuator rod relative to the tubular member <NUM> can draw the distal collar <NUM> towards the proximal collar <NUM> and transition the vessel shaping device <NUM> to the expanded configuration. As shown in <FIG>, in an embodiment, the actuator rod <NUM> can be slidably engaged with an outer surface of the tubular member <NUM> and can be coupled to the proximal collar <NUM>. Advancing the actuator rod <NUM> proximally can advance the proximal collar <NUM> towards the distal collar and transition the vessel shaping device <NUM> to the expanded configuration.

In an embodiment, the transverse distance (d1) can be greater than a lumen diameter (d3). As such the device <NUM> can be elastically deformed to fit within the lumen <NUM> of the catheter <NUM>. Advancing the device <NUM> can allow the device <NUM> to transition to the retracted configuration, defining the transverse distance (d1). Withdrawing the tubular member <NUM> can then engage a proximal end of the frame <NUM> against a distal tip <NUM> of the catheter, urging the proximal collar <NUM> towards the distal collar <NUM> and transitioning the vessel shaping device <NUM> to the extended configuration. Advantageously, a user can modify the configuration of the vessel shaping device <NUM> between the retracted configuration and the extended configuration to modify a cross-sectional area of the vessel <NUM> and modify an amount of fluid flow therethrough.

In an embodiment, the vessel shaping device <NUM> can be formed of a resilient, material, elastically deformable material, malleable material, super-elastic, or shape memory material. In an embodiment, the vessel shaping device <NUM> can include metal, alloy, stainless steel, Nitinol, plastic, polymer, carbon based material, carbon fiber material, composite materials, combinations thereof, or the like. In an embodiment, the vessel shaping device <NUM> can be shaped from the retracted configuration to the expanded configuration and remain in the expanded configuration until reshaped.

In an embodiment, the vessel shaping device <NUM> can be selectively detachable from the tubular member <NUM>. The vessel shaping device <NUM> can then remain at the target location, reshaping the vessel <NUM> along the transverse axis to the flattened configuration, while the tubular member <NUM> and catheter <NUM> can be withdrawn. In an embodiment, the vessel shaping device <NUM> can be retrieved by extending the tubular member <NUM>, or similar device, to selectively engage the vessel shaping device <NUM>, e.g. grasping a proximal portion thereof. The tubular member <NUM> and vessel shaping device <NUM> can then be withdrawn proximally into the lumen <NUM> of the catheter <NUM> and removed from the vasculature of the patient. Advantageously, the stability members <NUM>, <NUM> can provide extra strength or support to the arms <NUM>, <NUM> at the location of the apices <NUM>, <NUM>. In an embodiment, the stability members <NUM>, <NUM> can provide additional elastic strength biasing the vessel shaping device <NUM> towards one of the extended or retracted configurations, as described herein.

As shown in <FIG>, in an embodiment, a vessel shaping device <NUM> can include an articulated frame <NUM> having a first arm <NUM> and a second arm <NUM> each extending transversely from the tubular member <NUM> and each including two or more members hingedly coupled to each other. For example, the first arm <NUM> can include a proximal member <NUM> hingedly coupled to a distal member <NUM> to create an apex <NUM>. In an embodiment, the proximal member <NUM> can be hingedly coupled to an apex member <NUM> at a proximal end. The apex member <NUM> can extend substantially parallel to the tubular member <NUM> to a distal end that is hingedly coupled to a distal member <NUM>. In an embodiment, a proximal end of the proximal member <NUM> can be hingedly coupled to a proximal collar <NUM>. A distal end of the distal member <NUM> can be hingedly coupled to a distal collar <NUM>.

The second arm <NUM> can include a proximal member <NUM> hingedly coupled to a distal member <NUM> to create an apex <NUM>. In an embodiment, the proximal member <NUM> can be hingedly coupled to an apex member <NUM> at a proximal end. The apex member <NUM> can extend substantially parallel to the tubular member <NUM> to a distal end that is hingedly coupled to a distal member <NUM>. In an embodiment, a proximal end of the proximal member <NUM> can be hingedly coupled to a proximal collar <NUM>. A distal end of the distal member <NUM> can be hingedly coupled to a distal collar <NUM>.

In an embodiment, one of the proximal collar <NUM> or the distal collar <NUM> can be integrally formed with the tubular member <NUM>. In an embodiment, one of the proximal collar <NUM> or the distal collar <NUM> can be threadably engaged with the tubular member <NUM> and rotating the tubular member <NUM> can move one of the proximal collar <NUM> or the distal collar <NUM> along a longitudinal axis relative to the vessel shaping device <NUM>. In an embodiment, a distal portion of the tubular member <NUM> can include a threaded portion <NUM>. In an embodiment, the threaded portion <NUM> can include a multi-lead thread where a single rotation of the tubular member <NUM> can provide a greater longitudinal movement of one of the proximal collar <NUM> or the distal collar <NUM> relative to a single-lead thread. For example, a quad lead thread can provide four times more longitudinal movement per rotation relative to a single lead thread.

In an embodiment, the threaded portion <NUM> can include a right-handed threaded portion and a left-handed threaded portion. In an embodiment, the proximal collar <NUM> can be threadably engaged with the right-handed threaded portion and the distal collar <NUM> can be can be threadably engaged with the left-handed threaded portion. In an embodiment, the proximal collar <NUM> can be threadably engaged with the left-handed threaded portion and the distal collar <NUM> can be can be threadably engaged with the right-handed threaded portion. Rotating the tubular member <NUM> can move both the proximal collar <NUM> and the distal collar <NUM> along a longitudinal axis to change a longitudinal distance (L) therebetween. As shown in <FIG>, a first length (L1) between the proximal collar <NUM> and the distal collar <NUM> can provide a first transverse distance (d1) between the first apex <NUM> and the second apex <NUM>. Rotating the tubular member <NUM> can provide a second longitudinal distance (L2), which is less than the first longitudinal distance (L1), and provides a second transverse distance (d2) between the first apex <NUM> and the second apex <NUM> that is greater than first distance (d1).

In an embodiment, a first transverse distance (d1) is equal to or less than a diameter of the vessel <NUM> in a resting configuration. In an embodiment, a first transverse distance (d1) is equal to or less than a diameter (d3) of the catheter <NUM>. The second transverse distance (d2) is greater than a diameter of the vessel <NUM> in a resting configuration. As such the vessel reshaping device <NUM> can reshape the vessel <NUM> to a flattened configuration by increasing a transverse axis to reduce a lateral axis of the vessel <NUM> and reduce a cross-sectional area of the vessel <NUM>.

In an embodiment, the reshaping device <NUM> can be selectively releasable from the tubular member <NUM>. For example, the tubular member <NUM> can include a release mechanism <NUM> configured to selectably release a distal portion of the tubular member <NUM> including the threaded portion <NUM> and the vessel shaping device <NUM>. As such the vessel shaping device <NUM> can remain at the target location while the catheter <NUM> and tubular member <NUM> are withdrawn.

In an exemplary method of use, a vessel shaping device <NUM> and threaded tubular member <NUM> can be provided as described herein. In an embodiment, the longitudinal distance (L) between the proximal collar <NUM> and the distal collar <NUM> can be configured such that a transverse distance (d1) is less than a diameter (d3) of the catheter lumen <NUM>. Once at the target location, the tubular member <NUM> can be urged distally to urge the vessel shaping device <NUM> distally of the distal tip <NUM> of the catheter <NUM>. The tubular member <NUM> can then be rotated to reduce a longitudinal length (L) between the proximal collar <NUM> and the distal collar <NUM>. In turn, this can increase the transverse distance between the first apex <NUM> and the second apex <NUM> to distance (d2) that is greater than a transverse diameter of the vessel <NUM> in the resting configuration and reshape the vessel <NUM> to a flattened configuration (<FIG>), as described herein. In an embodiment, the tubular member <NUM> can selectively release the vessel shaping device <NUM> by detaching the engagement mechanism <NUM>.

In an embodiment, the vessel shaping device <NUM> can be removed by reconnecting the engagement mechanism <NUM> and rotating the tubular member <NUM> in an opposite direction. The longitudinal distance (L) between the proximal collar <NUM> and the distal collar <NUM> can be increased which can decrease a transverse distance between the first apex <NUM> and the second apex <NUM> from a distance (d2) to a distance (d1) to allow the vessel <NUM> to resume the resting configuration. The vessel shaping device <NUM> can then be withdrawn into the catheter <NUM> and removed from the vasculature of the patient.

As shown in <FIG>, in an embodiment, a vessel shaping device <NUM> can include an articulated frame <NUM> configured to transition between a retracted configuration (<FIG>) and an extended configuration (<FIG>). The vessel shaping device <NUM> can include a first arm <NUM> and a second arm <NUM> extending transversely from a tubular member <NUM>. The first arm <NUM> can include a first proximal member <NUM> hingedly coupled to a first distal member <NUM> to define a first apex <NUM>. The second arm <NUM> can include a second proximal member <NUM> hingedly coupled to a second distal member <NUM> to define a second apex <NUM>. A proximal end of the proximal member <NUM> can be hingedly coupled to a proximal collar <NUM>. A distal end of the distal member <NUM> can be hingedly coupled to a distal collar <NUM>. In an embodiment, the distal collar <NUM> can define an atraumatic tip. In an embodiment, a distal tip of the tubular member <NUM> or actuator rod <NUM> can define an atraumatic tip.

In an embodiment, one of the proximal collar <NUM> or the distal collar <NUM> can be fixedly coupled to the tubular member <NUM>. In an embodiment, one of the proximal collar <NUM> or the distal collar <NUM> can be slidably engaged with the tubular member <NUM>. In an embodiment, the vessel shaping device <NUM> can include a biasing member <NUM> aligned with the longitudinal axis and disposed between the proximal collar <NUM> and the distal collar <NUM>. The biasing member, e.g. a compression spring, is configured to bias the vessel shaping device <NUM> towards the retracted configuration.

In the retracted configuration, a transverse distance (d1) between the first apex <NUM> and the second apex <NUM> can be less than a diameter of the vessel <NUM> in a resting state. In an embodiment, in the retracted configuration, a transverse distance (d1) between the first apex <NUM> and the second apex <NUM> can be less than a diameter (d3) of the catheter lumen <NUM>.

In an embodiment, the tubular member <NUM> can include an actuator rod <NUM>. In an embodiment, the actuator rod <NUM> can be slidably engaged with an interior of the tubular member <NUM>. In an embodiment, the actuator rod <NUM> can define a sleeve, slidably engaged with an exterior of the tubular member <NUM>. However, it will be appreciated that other configurations of tubular member <NUM> and actuator rod <NUM> are also contemplated.

In an embodiment, actuating the actuator rod <NUM> can slide the proximal collar <NUM> relative to the distal collar <NUM> such that a longitudinal distance (L) between the proximal collar <NUM> and the distal collar <NUM> is reduced which can cause the transverse distance (d) between the first apex <NUM> and the second apex <NUM> to be increased to transverse distance (d2) to extend the transverse diameter of the vessel <NUM>, reducing the lateral diameter of the vessel <NUM> to transition the vessel <NUM> to a flattened configuration and reduce the cross-sectional area of the vessel <NUM>, as described herein.

In an embodiment, one of the proximal collar <NUM> or the distal collar <NUM> can include a locking mechanism <NUM>. For example, as shown, the proximal collar <NUM> can including a locking mechanism configured to lock the proximal collar <NUM> relative to the tubular member <NUM>, and/or actuator rod <NUM>, to secure the vessel shaping device <NUM> in the extended configuration.

In an embodiment, the locking mechanism <NUM> can include a dowel slidably engaged with the tubular member <NUM> or the actuator rod <NUM> and biased towards a locked position. When the dowel aligns with an aperture disposed on the proximal collar <NUM>, the dowel can transition to the locked position and engage the aperture to inhibit further longitudinal movement of the proximal collar <NUM>. In an embodiment, a second actuator mechanism can be configured to retract the dowel, disengaging the aperture and allow the biasing member <NUM> to slide the proximal collar <NUM> relative to the tubular member <NUM>/actuator rod <NUM> to the retracted configuration. It will be appreciated that various other configurations of locking mechanisms <NUM> are also contemplated including locking the distal collar <NUM> to the tubular member <NUM>. Further, various other locking mechanisms <NUM> are also contemplated including pawls, ratchets, gears, worm-wheels, combinations thereof, or the like.

In an exemplary method of use, a vessel shaping device <NUM> including a tubular member <NUM> and actuator rod <NUM> is provided, as described herein. The vessel shaping device <NUM> can be disposed within a proximal portion of a catheter <NUM> and advanced into vasculature of a patient to a target location. The tubular member <NUM> can be advanced until the vessel shaping device <NUM> is urged distally of a distal tip <NUM> of the catheter <NUM>. The actuator rod <NUM> can be actuated which can compress the biasing member <NUM> and reduce a longitudinal distance (L) between the proximal collar <NUM> and the distal collar <NUM>. As such, a transverse distance (d) between the first apex <NUM> and the second apex <NUM> is increased to a transverse distance (d2), i.e. the extended configuration, and a cross-sectional shape of the vessel <NUM> can be reshaped from the resting configuration to a flattened configuration. In an embodiment, in the extended configuration, the locking mechanism <NUM> can engage to prevent further longitudinal movement of one of the proximal collar <NUM> or the distal collar <NUM> to lock the vessel shaping device <NUM> in the extended configuration.

In an embodiment, the actuator rod <NUM> is slidably engaged with an interior of the tubular member <NUM>, and can withdraw a distal collar <NUM> proximally towards the proximal collar <NUM> to transition the vessel shaping device <NUM> to the extended configuration. In an embodiment, the actuator rod <NUM> is slidably engaged with an exterior of the tubular member <NUM> and can advance a proximal collar <NUM> distally towards the distal collar <NUM> to transition the vessel shaping device <NUM> to the extended configuration. However, it will be appreciated that other combinations of slidable actuator rod <NUM>, proximal collar <NUM>, or distal collar <NUM> are also contemplated. In an embodiment, the vessel shaping device <NUM> can be selectively disengaged from the tubular member <NUM> to remain at the target location while the tubular member <NUM> and the catheter can be withdrawn.

In an embodiment, a proximal end of the tubular member <NUM> can include a handle or similar structure configured to facilitate grasping and manipulating the tubular member <NUM> and vessel shaping device <NUM> disposed at a distal end thereof. Further the handle can include one or more buttons, levers, or the like configured to actuate the actuator rod <NUM>, locking mechanism <NUM>, or combinations thereof.

In an embodiments, of the vessel shaping device <NUM>, <NUM>, <NUM>, disclosed herein can be formed of a metal, alloy, superelastic alloy, stainless steel, Nitinol, plastic, polymer, carbon based material, carbon fiber, composite material, combinations thereof, or the like. Advantageously, embodiments of the vessel shaping device can be formed of a material that mitigate the formation of thromboses. Further, embodiments of the vessel shaping device provide a low profile structure with a reduced surface area to further mitigate the formation of thromboses. In an embodiment, embodiments of the vessel shaping device, or components thereof, can include a coating, for example an anti-thrombotic coating or the like to further mitigate the formation of thromboses.

Claim 1:
A blood flow regulating device for a vessel, comprising:
a delivery catheter (<NUM>) extending along a longitudinal axis; and
a vessel shaping device (<NUM>) having a retracted configuration in the delivery catheter (<NUM>) and an expanded configuration out of the delivery catheter (<NUM>), the vessel shaping device (<NUM>) being arranged to expand to the expanded configuration along a transverse axis, perpendicular to the longitudinal axis of the delivery catheter (<NUM>), to reshape the vessel to a flattened configuration, wherein the vessel shaping device (<NUM>) comprises a frame (<NUM>) including a first arm (<NUM>) extending transversely outward from the central longitudinal axis to define a first apex (<NUM>), and a second arm (<NUM>) extending transversely outward from the central longitudinal axis in an opposite direction from the first arm (<NUM>) to define a second apex (<NUM>), a proximal end of the first arm (<NUM>) and a proximal end of the second arm (<NUM>) are coupled to a proximal collar (<NUM>), and a distal end of the first arm (<NUM>) and a distal end of the second arm (<NUM>) are coupled to a distal collar (<NUM>), characterized in that:
the vessel shaping device (<NUM>) further comprises a first stability member (<NUM>) extending across the first apex from a proximal portion of the first arm (<NUM>) to a distal portion of the first arm (<NUM>), and a second stability member (<NUM>) extending across the second apex from a proximal portion of the second arm (<NUM>) to a distal portion of the second arm (<NUM>).