Reduced flow catheter for liquid overload treatment

Abstract

Disclosed herein is a vessel reshaping device configured to reshape a vessel along a single axis and modulate blood flow therethrough. The vessel reshaping device generally consists of a frame that can be transformed into an expanded configuration and can temporarily reshape a vessel, such as the inferior vena cava (IVC), along a single axis perpendicular to the longitudinal axis. The more the reshaping device expands, the more the cross-sectional area decreases, and in turn, the more the flow through the vessel decreases. Thus, altering the blood flow to the heart can improve the symptoms of hypervolemia, thereby increasing diuretic effect and improving the symptoms of congestive heart failure.

Description

Background Art

[0001] Congestive heart failure is a condition in which the heart cannot pump enough blood to meet the body's needs. When the heart's ability to pump blood decreases, the kidneys cannot function properly, leading to excess fluid in the body, a condition called "hypervolemia." Hypervolemia symptoms can vary depending on where the fluid accumulates and the presence of other health problems. The most common symptoms include unexplained rapid weight gain, swelling in the arms and legs, abdominal swelling, and shortness of breath due to fluid accumulation in the lungs.

[0002] There are several ways to treat hypervolemia. One of the most common treatments for hypervolemia is diuretics. Diuretics are medications that increase the body's production of urine. Increased urination, in turn, reduces fluid overload. However, some patients do not respond well to diuretic therapy. Evidence suggests that symptoms of fluid overload can be improved by temporarily reducing blood flow to the heart, thereby increasing diuresis efficiency and further improving the patient's condition. Summary of the Invention

[0003] Embodiments disclosed herein relate to a vascular reshaping device for temporarily restricting blood flow to the heart. The vascular reshaping device can provide a simpler structure, have a lower profile, and can eliminate the need for any membrane to reduce blood flow. Advantageously, the vascular reshaping device reduces the risk of thrombosis because the low-profile frame is less likely to form a thrombosis than a membrane, and there is no risk of the membrane detaching or causing thrombosis during delivery, use, or retraction of the device.

[0004] A vascular reshaping device generally consists of a frame that can temporarily reshape a vessel, such as the inferior vena cava (IVC), along a single axis extending perpendicular to the direction of blood flow, thereby reducing the cross-sectional area and blood flow through the vessel. The more the reshaping device expands, the greater the reduction in cross-sectional area, and the greater the reduction in flow. For example, expanding the transverse axis of a substantially circular vessel by 50% can substantially reduce the cross-sectional area of ​​the vessel by 50%. As used herein, a longitudinal axis extends substantially parallel to the direction of blood flow through the vessel. It is noted that the vascular reshaping device may not significantly stretch the vessel wall, but rather primarily reshape the vessel wall, although some stretching may occur.

[0005] The present invention discloses a blood flow regulation device for a vessel, which includes a delivery catheter extending along a longitudinal axis, and a vessel shaping device, the vessel shaping device having a retracted configuration in the delivery catheter and an expanded configuration outside the delivery catheter, and the vessel shaping device is arranged to expand into an expanded configuration along a transverse axis perpendicular to the longitudinal axis of the delivery catheter to reshape the vessel into a flat configuration.

[0006] In some embodiments, the flattened configuration of the vessel defines an extended transverse diameter, a reduced lateral diameter, and a cross-sectional area that is smaller than the cross-sectional area of ​​the vessel in the resting configuration. The vessel shaping device is formed of Nitinol. The vessel shaping device includes a frame, the frame including a first arm extending laterally outward from a central longitudinal axis to define a first vertex, and a second arm extending laterally outward from the central longitudinal axis in an opposite direction to the first arm to define a second vertex, the proximal end of the first arm and the proximal end of the second arm are connected to a proximal collar, and the distal end of the first arm and the distal end of the second arm are connected to a distal collar.

[0007] In some embodiments, the vascular shaping device further comprises a tubular member coupled to the frame. In some embodiments, the tubular member is fixedly attached to the distal collar and slidably engaged with the proximal collar, the distal collar defining a non-damaging end. In some embodiments, the tubular member is slidably engaged with the distal collar and fixedly attached to the proximal collar, the distal end of the tubular member defining a non-damaging end. In some embodiments, movement of the tubular member or the actuator rod in one of the proximal or distal directions further expands the vascular shaping device along the transverse axis. The vascular shaping device further comprises a first stabilizing member extending from the proximal portion of the first arm across the first vertex to the distal portion of the first arm, and a second stabilizing member extending from the proximal portion of the second arm across the second vertex to the distal portion of the second arm. The first stabilizing member or the second stabilizing member extends laterally inward toward the central longitudinal axis.

[0008] Also disclosed is a vascular shaping device comprising a tubular member extending along a longitudinal axis and a frame coupled to a distal end of the tubular member, the frame comprising a first articulated arm and a second articulated arm, the first articulated arm comprising a first proximal member articulatedly coupled to the first distal member to define a first vertex, the first proximal member being coupled to a proximal collar, and the first distal member being coupled to the distal collar, the second articulated arm comprising a second proximal member articulatedly coupled to the second distal member to define a second vertex, the second proximal member being coupled to the proximal collar, and the second distal member being coupled to the distal collar.

[0009] In some embodiments, one of the proximal collar or the distal collar is threadedly engaged with the tubular member. The proximal collar is threadedly engaged with one of the right-hand thread or the left-hand thread, and the distal collar is threadedly engaged with one of the left-hand thread or the right-hand thread. Rotation of the tubular member causes the first vertex and the second vertex to extend away from the longitudinal axis along the transverse axis, thereby transforming the vessel shaping device into an expanded configuration. In some embodiments, the vessel shaping device further includes a first vertex member extending substantially parallel to the longitudinal axis and hingedly coupled to the first proximal member and the first distal member, and a second vertex 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 toward a retracted configuration. In some embodiments, the vessel shaping device further includes a locking mechanism configured to releasably lock the proximal collar or the distal collar relative to the tubular member to prevent longitudinal movement thereof.

[0010] Also disclosed is a method for regulating blood flow in a vessel, comprising inserting a delivery catheter into the vessel, moving a vessel shaping device out of the 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 the longitudinal axis of the delivery catheter to reshape the vessel from a resting configuration to a flattened configuration.

[0011] In some embodiments, the method further includes advancing the tubular member distally relative to the delivery catheter to convert the vascular shaping device into an expanded configuration. In some embodiments, the method further includes withdrawing the tubular member proximally relative to the delivery catheter to convert the vascular shaping device into an expanded configuration after the vascular shaping device is moved out of the distal end of the delivery catheter. In some embodiments, the method further includes rotating the tubular member relative to the delivery catheter to convert the vascular shaping device into an expanded configuration. In some embodiments, the method further includes advancing the actuator rod distally relative to the tubular member to convert the vascular shaping device into an expanded configuration. In some embodiments, the method further includes locking the vascular shaping device into an expanded configuration. In some embodiments, the method further includes selectively separating the vascular shaping device from the tubular member. In an embodiment, a portion of the vascular shaping device includes a radiopaque marker. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] A more detailed description of the disclosure will be presented by reference to specific embodiments of the disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and, therefore, should not be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

[0013] Figure 1A Shown is a side view of a vascular reshaping device in a first configuration according to embodiments disclosed herein.

[0014] Figure 1B shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 1A Distal view of the vascular reshaping device.

[0015] Figure 1C Shown is a side view of a vascular reshaping device in a second expanded configuration according to embodiments disclosed herein.

[0016] Figure 1D shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 1C Distal view of the vascular reshaping device.

[0017] Figure 2A Shown is a side view of a vascular reshaping device in a first configuration according to embodiments disclosed herein.

[0018] Figure 2B shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 2A Distal view of the vascular reshaping device.

[0019] Figure 2C Shown is a side view of a vascular reshaping device in a second expanded configuration according to embodiments disclosed herein.

[0020] Figure 2D shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 2C Distal view of the vascular reshaping device.

[0021] Figure 3A Shown is a side view of a vascular reshaping device in a first configuration according to embodiments disclosed herein.

[0022] Figure 3B shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 3A Distal view of the vascular reshaping device.

[0023] Figure 3C Shown is a side view of a vascular reshaping device in a second expanded configuration according to embodiments disclosed herein.

[0024] Figure 3D shows a cross-sectional view of a vessel according to embodiments disclosed herein and Figure 3C Distal view of the vascular reshaping device. DETAILED DESCRIPTION

[0025] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the features of the specific embodiments disclosed herein can be easily separated from the specific embodiments and optionally combined or substituted for the features of any one of the multiple other embodiments disclosed herein.

[0026] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concept provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify the different features or steps in a set of features or steps, without the restriction of sequential arrangement or number. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiment including these features or steps is not necessarily limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back" etc. are used for convenience and are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. Unless the context clearly provides otherwise, the singular "one", "a kind of" and "the" include plural forms.

[0027] With respect to the "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter includes the portion of the catheter that is intended to be near a clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be near a clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be near a clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter do not necessarily include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal portion, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0028] About " distal ", for example, " distal portion " or " distal part " of catheter comprises the part of the catheter that is expected to be near the patient or in the patient's body when catheter is used on the patient. Likewise, for example, " distal length " of catheter comprises the length of the catheter that is expected to be near the patient or in the patient's body when catheter is used on the patient. For example, " distal end " of catheter comprises the end of this catheter that is expected to be near the patient or in the patient's body when catheter is used on the patient. The distal portion, distal portion or distal length of catheter can comprise the distal end of catheter; However, the distal portion, distal portion or distal length of catheter do not necessarily comprise the distal end of catheter. That is, unless the context indicates otherwise, the distal portion, distal portion or distal length of catheter is not the terminal portion or terminal length of catheter.

[0029] As used herein, and as Figure 1A As shown, the longitudinal axis extends along the axial length of the catheter, substantially parallel to the direction of flow through the vessel, the lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and transverse axes.

[0030] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0031] Figures 1A to 1D An embodiment of a vascular shaping device 100 according to embodiments disclosed herein is shown. The vascular shaping device 100 can be disposed at the distal end of a tubular member 102, such as a stylet, hypotube, or similar elongated medical device configured to extend along a longitudinal axis through a lumen 92 of a delivery catheter ("catheter") 90. The catheter 90 can include an introducer, catheter, or similar device configured to deliver the vascular shaping device 100 to a target location within the patient's vasculature. In an embodiment, the tubular member 102 can define a lumen 104 configured to receive a guidewire, an actuator rod, or similar elongated device therethrough.

[0032] The vessel shaping device 100 can include a frame 110 extending from the tubular member 102 along an axis extending perpendicular to the longitudinal axis, such as a transverse axis, a lateral axis, or a combination thereof. For ease of explanation, the 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.

[0033] The frame 110 may include a first arm 112 extending from the tubular member 102 in a first direction and defining a first apex 114. The frame 110 may include a second arm 122 extending from the tubular member 102 in a second direction opposite the first direction and defining a second apex 124.

[0034] In an embodiment, one of the proximal or distal ends of the first arm 112 can be integrally formed with the tubular member 102. In an embodiment, one of the proximal or distal ends of the first arm 112 can be slidably engaged with the tubular member 102. In an embodiment, one of the proximal or distal ends of the first arm 112 can be coupled to a collar, which can be fixedly coupled to the tubular member 102 or can be slidably engaged with the tubular member 102. For example, the proximal end of the first arm 112 can be coupled to the proximal collar 130 and the distal end of the first arm 112 can be coupled to the distal collar 132. In an embodiment, the distal collar 132 can define an atraumatic tip. In an embodiment, a portion of the frame 100 can include a radiopaque or acoustically opaque material to facilitate viewing of the frame under imaging (e.g., X-ray, fluoroscope, ultrasound, MRI, etc.). In an embodiment, one of the proximal loop 130, the distal loop 132, the first arm 112, the second arm 122, the first apex 114, the second apex 124, a portion thereof, or a combination thereof may include a radiopaque or acoustically opaque material to identify the periphery of the frame 100 under imaging and facilitate proper positioning of the frame 100 within the vessel 80.

[0035] In an embodiment, one of the proximal end or the distal end of the second arm 122 can be integrally formed with the tubular member 102. In an embodiment, one of the proximal end or the distal end of the second arm 122 can be slidably engaged with the tubular member 102. In an embodiment, one of the proximal end or the distal end of the second arm 122 can be coupled with a collar, which can be coupled in a fixed relationship with the tubular member 102 or can be slidably engaged with the tubular member 102. For example, the proximal end of the second arm 122 can be coupled with the proximal collar 130 and the distal end of the second arm 122 can be coupled with the distal collar 132.

[0036] In an embodiment, one of the first arm 112 or the second arm 122 can include a stabilizing member. For example, the first arm 112 can include a first stabilizing member 116 that extends across a first vertex 114 between a proximal portion and a distal portion of the first arm 112. The first stabilizing member 116 can extend laterally inward toward the central longitudinal axis. As described in more detail herein, the first stabilizing member 116 can further support elastic deformation of the first arm 112. Similarly, the second arm 122 can include a second stabilizing member 126 that extends across a second vertex 124 between a proximal portion and a distal portion of the second arm 122. The second stabilizing member 126 can extend laterally inward toward the central longitudinal axis. As described in more detail herein, the second stabilizing member 126 can further support elastic deformation of the second arm 122.

[0037] In an embodiment, the first arm 112 and the second arm 122 of the frame 110 can be in a retracted configuration (e.g., Figure 1A ) and the extended configuration (e.g. Figure 1C ) between elastic deformation.

[0038] In an embodiment, the vascular shaping device 100 can be biased toward the retracted configuration such that, at rest, the vascular shaping device 100 defines a first lateral distance (d1) between the first vertex 114 and the second vertex 124. In an embodiment, the first lateral distance (d1) can be greater than the diameter (d3) of the catheter lumen 92. In an embodiment, the first lateral distance (d1) can be less than the diameter (d3) of the catheter lumen 92. In an embodiment, the vascular shaping device 100 can be biased toward the extended configuration such that, at rest, the vascular shaping device 100 defines a second distance (d2) between the first vertex 114 and the second vertex 124, the second distance (d2) being greater than the first distance (d1). In an embodiment, the vascular shaping device 100 in the retracted configuration defines a lateral distance (d1) that is greater than the diameter (d3) of the catheter lumen 92. The vessel shaping device 100 can be elastically deformed into a compact configuration (not shown) in which the lateral distance between the first apex 114 and the second apex 124 is less than the diameter ( d3 ) of the catheter lumen 92 .

[0039] like Figure 1B As shown, in the retracted configuration, the distance (d1) between the first vertex 114 and the second vertex 124 can be equal to or less than the diameter of the vessel 80 in the resting position. It is noted that the vessel 80 in the resting position can define a circular or slightly elliptical cross-sectional shape. Figure 1D As shown, in the extended configuration, the distance (d2) between the first vertex 114 and the second vertex 124 can be greater than the resting diameter of the vessel 80 at the target location. Thus, the diameter of the vessel 80 can be reshaped along a first axis (e.g., a transverse axis) to a flat configuration. Thus, in the flat configuration, the second axis (e.g., a lateral axis) of the vessel 80 is reduced. In addition, the vessel 80 in the flat configuration (e.g., Figure 1D ) can be smaller than the cross-sectional area of ​​the vessel 80 in the resting configuration (e.g. Figure 1B ). For example, a vessel 80 that is substantially circular in its resting configuration can be reshaped into a flattened configuration by extending its transverse axis by 50%. In this flattened configuration, the cross-sectional area of ​​the vessel can be reduced by 50%. However, it should be understood that reshaping to reduce the cross-sectional area by a greater or lesser ratio is also contemplated.

[0040] In an exemplary method of use, a vessel shaping device 100 can be provided as described herein. The vessel shaping device 100 can be positioned within the lumen 92 of a delivery catheter 90 and advanced to a target location within the patient's vasculature. Once the target location is approached, the tubular member 102 can be pushed distally to advance the vessel shaping device 100 distally of the distal tip 94 of the catheter 90. The vessel shaping device 100 can then be transformed into an extended configuration to define a lateral distance (d2) between the first vertex 114 and the second vertex 124, and reshape the vessel 80 from the rest configuration to a flattened configuration and reduce the cross-sectional area of ​​the vessel 80.

[0041] In embodiments, the vessel shaping device 100 can be biased toward an extended configuration and can be elastically deformed into a retracted configuration to fit within the lumen 92 of the catheter 90. Thus, when the vessel shaping device 100 is advanced distally of the distal tip 94 of the catheter 90, the device 100 can expand into the expanded configuration and transform the vessel into a flattened configuration.

[0042] In an embodiment, the vascular shaping device 100 can be biased toward a retracted configuration that defines a lateral distance (d1). Thus, when the vascular shaping device 100 is advanced distally of the distal tip 94 of the catheter 90, the handheld portion coupled to the proximal end of the tubular member 102 can be actuated to transform the device 100 into an expanded configuration. In an embodiment, the tubular member 102 can include an actuator that is operably coupled to one of the proximal collar 130 or the distal collar 132 to selectively transform the vascular shaping device 100 between the retracted configuration and the extended configuration. For example, an actuator rod can extend through the lumen 104 of the tubular member 102 to the distal collar 132. Withdrawing the actuator rod relative to the tubular member 102 can pull the distal collar 132 toward the proximal collar 130 and transform the vascular shaping device 100 into an expanded configuration. In an embodiment, as Figure 1A and Figure 1C As shown, actuation rod 108 can be slidably engaged with an outer surface of tubular member 102 and can be coupled to proximal collar 130. Advancing actuation rod 108 proximally can advance proximal collar 130 toward the distal collar and transition vascular shaping device 100 to the expanded configuration.

[0043] In an embodiment, the lateral distance (d1) can be greater than the lumen diameter (d3). Thus, the device 100 can be elastically deformed to fit within the lumen 92 of the catheter 90. Advancing the device 100 can allow the device 100 to be converted into a retracted configuration, thereby limiting the lateral distance (d1). Then, withdrawing the tubular member 102 can cause the proximal end of the frame 110 to engage the distal end 94 of the catheter, pushing the proximal collar 130 toward the distal collar 132 and converting the vessel shaping device 100 into an extended configuration. Advantageously, the user can change the configuration of the vessel shaping device 100 between the retracted configuration and the extended configuration to change the cross-sectional area of ​​the vessel 80 and change the amount of fluid flow passing therethrough.

[0044] In an embodiment, the vessel shaping device 100 can be formed of an elastic material, an elastically deformable material, a plastic material, a superelastic material, or a shape memory material. In an embodiment, the vessel shaping device 100 can include metal, alloy, stainless steel, Nitinol, plastic, polymer, carbon-based material, carbon fiber material, composite material, combinations thereof, etc. In an embodiment, the vessel shaping device 100 can change from a retracted configuration to an expanded configuration and remain in the expanded configuration until reshaping is performed.

[0045] In an embodiment, the vessel shaping device 100 can be selectively detachable from the tubular member 102. The vessel shaping device 100 can then remain at the target location, reshaping the vessel 80 into a flat configuration along the transverse axis while the tubular member 102 and the catheter 90 are withdrawn. In an embodiment, the vessel shaping device 100 can be retracted by selectively engaging the vessel shaping device 100 (e.g., grabbing its proximal portion) by extending the tubular member 102 or a similar device. The tubular member 102 and the vessel shaping device 100 can then be withdrawn proximally into the lumen 92 of the catheter 90 and removed from the patient's vascular system. Advantageously, the stabilizing members 116, 126 can provide additional strength or support for the arms 112, 122 at the locations of the apexes 114, 124. In an embodiment, as described herein, the stabilizing members 116, 126 can provide additional elastic strength to bias the vessel shaping device 100 toward one of the extended or retracted configurations.

[0046] like Figures 2A to 2DAs shown, in embodiments, the vessel shaping device 200 may include an articulated frame 210 having a first arm 212 and a second arm 222, each extending transversely from a tubular member 202 and each comprising two or more members hingedly coupled to one another. For example, the first arm 212 may include a proximal member 216 hingedly coupled to a distal member 218 to form an apex 214. In embodiments, the proximal member 216 may be hingedly coupled to the apex member 214 at a proximal end. The apex member 214 may extend substantially parallel to the tubular member 202 to a distal end hingedly coupled to the distal member 218. In embodiments, the proximal end of the proximal member 216 may be hingedly coupled to a proximal collar 230. The distal end of the distal member 218 may be hingedly coupled to a distal collar 232.

[0047] The second arm 222 can include a proximal member 226 hingedly coupled to a distal member 228 to form an apex 224. In an embodiment, the proximal member 226 can be hingedly coupled to the apex member 224 at a proximal end. The apex member 224 can extend substantially parallel to the tubular member 202 to a distal end hingedly coupled to the distal member 228. In an embodiment, the proximal end of the proximal member 226 can be hingedly coupled to a proximal collar member 230. The distal end of the distal member 228 can be hingedly coupled to a distal collar 232.

[0048] In an embodiment, one of the proximal collar 230 or the distal collar 232 can be integrally formed with the tubular member 202. In an embodiment, one of the proximal collar 230 or the distal collar 232 can be threadedly engaged with the tubular member 202, and rotation of the tubular member 202 can cause one of the proximal collar 230 or the distal collar 232 to move along the longitudinal axis relative to the vascular shaping device 200. In an embodiment, the distal portion of the tubular member 202 can include a threaded portion 204. In an embodiment, the threaded portion 204 can include a multi-lead thread, wherein a single rotation of the tubular member 202 can cause one of the proximal collar 230 or the distal collar 232 to move more longitudinally than a single-lead thread. For example, a quad-lead thread can cause four times more longitudinal movement per rotation than a single-lead thread.

[0049] In an embodiment, the threaded portion 204 may include a right-handed threaded portion and a left-handed threaded portion. In an embodiment, the proximal collar 230 may be threadedly engaged with the right-handed threaded portion, and the distal collar 232 may be threadedly engaged with the left-handed threaded portion. In an embodiment, the proximal collar 230 may be threadedly engaged with the left-handed threaded portion, and the distal collar 232 may be threadedly engaged with the right-handed threaded portion. Rotating the tubular member 202 may move both the proximal collar 230 and the distal collar 232 along the longitudinal axis so that the longitudinal distance (L) therebetween changes. Figure 2A As shown, a first length (L1) between the proximal loop 230 and the distal loop 232 can provide a first transverse distance (d1) between the first apex 214 and the second apex 224. Rotating the tubular member 202 can provide a second longitudinal distance (L2) that is less than the first longitudinal distance (L1) and a second transverse distance (d2) between the first apex 214 and the second apex 224 that is greater than the first distance (d1).

[0050] In an embodiment, the first transverse distance (d1) is equal to or less than the diameter of the vessel 80 in the resting configuration. In an embodiment, the first transverse distance (d1) is equal to or less than the diameter (d3) of the catheter 90. The second transverse distance (d2) is greater than the diameter of the vessel 80 in the resting configuration. Thus, the vessel reshaping device 200 can reduce the lateral axis of the vessel 80 and reduce the cross-sectional area of ​​the vessel 80 by increasing the transverse axis to reshape the vessel 80 into a flattened configuration.

[0051] In an embodiment, the reshaping device 200 can be selectively releasable from the tubular member 202. For example, the tubular member 202 can include a release mechanism 206 configured to selectively release a distal portion of the tubular member 202 including the threaded portion 204 and the vasculature reshaping device 200. Thus, when the catheter 90 and the tubular member 202 are withdrawn, the vasculature reshaping device 200 can remain at the target location.

[0052] In an exemplary method of use, a vessel shaping device 200 and a threaded tubular member 202 can be provided as described herein. In an embodiment, the longitudinal distance (L) between the proximal loop 230 and the distal loop 232 can be configured such that the transverse distance (d1) is less than the diameter (d3) of the catheter lumen 92. Once at the target location, the tubular member 202 can be pushed distally to push the vessel shaping device 200 distal to the distal tip 94 of the catheter 90. The tubular member 202 can then be rotated to reduce the longitudinal length (L) between the proximal loop 230 and the distal loop 232. In turn, as described herein, this can increase the transverse distance between the first vertex 214 and the second vertex 224 to a distance (d2) that is greater than the transverse diameter of the vessel 80 in the rest configuration and reshape the vessel 80 into a flat configuration ( Figure 2D In an embodiment, the tubular member 202 can selectively release the vessel shaping device 200 by disengaging the engagement mechanism 206 .

[0053] In an embodiment, the vessel shaping device 200 can be removed by reconnecting the engagement mechanism 206 and rotating the tubular member 202 in the opposite direction. The longitudinal distance (L) between the proximal and distal loops 230, 232 can be increased, which can reduce the transverse distance between the first and second apexes 214, 224 from distance (d2) to distance (d1) to allow the vessel 80 to return to its resting configuration. The vessel shaping device 200 can then be withdrawn into the catheter 90 and removed from the patient's vasculature.

[0054] like Figures 3A to 3D As shown, in an embodiment, the vessel shaping device 300 may include an articulated frame 310 configured to be in a retracted configuration ( Figure 3A ) and the extended configuration ( Figure 3C ). The vessel shaping device 300 may include a first arm 312 and a second arm 322 extending laterally from the tubular member 302. The first arm 312 may include a first proximal member 316 hingedly coupled to a first distal member 318 to define a first vertex 314. The second arm 322 may include a second proximal member 326 hingedly coupled to a second distal member 328 to define a second vertex 324. The proximal end of the proximal member 316 may be hingedly coupled to a proximal collar 330. The distal end of the distal member 316 may be hingedly coupled to a distal collar 332. In an embodiment, the distal collar 332 may define an atraumatic tip. In an embodiment, the distal tip of the tubular member 302 or the actuator rod 208 may define an atraumatic tip.

[0055] In an embodiment, one of the proximal loop 330 or the distal loop 332 can be fixedly coupled to the tubular member 302. In an embodiment, one of the proximal loop 330 or the distal loop 332 can be slidably engaged with the tubular member 302. In an embodiment, the vessel shaping device 300 can include a biasing member 340 aligned with the longitudinal axis and disposed between the proximal loop 330 and the distal loop 332. The biasing member (e.g., a compression spring) is configured to bias the vessel shaping device 300 toward the retracted configuration.

[0056] In the retracted configuration, the lateral distance (d1) between the first apex 314 and the second apex 324 can be less than the diameter of the vessel 80 at rest. In an embodiment, in the retracted configuration, the lateral distance (d1) between the first apex 314 and the second apex 324 can be less than the diameter (d3) of the catheter lumen 92.

[0057] In an embodiment, the tubular member 302 can include an actuation rod 308. In an embodiment, the actuation rod 308 can be slidably engaged with the interior of the tubular member 302. In an embodiment, the actuation rod 308 can define a sleeve that slidably engages with the exterior of the tubular member 302. However, it should be understood that other configurations of the tubular member 302 and the actuation rod 308 are also contemplated.

[0058] In an embodiment, as described herein, actuating the actuator rod 308 can cause the proximal loop 330 to slide relative to the distal loop 332 such that the longitudinal distance (L) between the proximal loop 330 and the distal loop 332 is reduced, which can increase the lateral distance (d) between the first vertex 314 and the second vertex 324 to a lateral distance (d2) to extend the lateral diameter of the vessel 80, thereby reducing the lateral diameter of the vessel 80 to transform the vessel 80 into a flat configuration and reduce the cross-sectional area of ​​the vessel 80.

[0059] In an embodiment, one of the proximal collar 330 or the distal collar 332 can include a locking mechanism 350. For example, as shown, the proximal collar 330 can include a locking mechanism configured to lock the proximal collar 330 relative to the tubular member 302 and / or the actuation rod 308 to secure the vessel shaping device 300 in the extended configuration.

[0060] In an embodiment, the locking mechanism 350 can include a pin member slidably engaged with the tubular member 302 or the actuation rod 308 and biased toward a locked position. When the pin member is aligned with an aperture disposed on the proximal collar 330, the pin member can transition to a locked position and engage the aperture to prevent further longitudinal movement of the proximal collar 330. In an embodiment, the second actuation mechanism can be configured to retract the pin member, thereby disengaging the aperture and allowing the biasing member 340 to slide the proximal collar 330 relative to the tubular member 302 / actuation rod 308 to a retracted configuration. It should be understood that various other configurations of the locking mechanism 350 are also contemplated, including locking the distal collar 332 to the tubular member 302. Furthermore, various other locking mechanisms 350 are also contemplated, including pawls, ratchets, gears, worm gears, combinations thereof, and the like.

[0061] In an exemplary method of use, a vessel-shaping device 300, as described herein, can be provided that includes a tubular member 302 and an actuation rod 308. The vessel-shaping device 300 can be disposed within a proximal portion of a catheter 90 and advanced to a target location in a patient's vasculature. The tubular member 302 can be advanced until the vessel-shaping device 300 is urged distally of the distal tip 94 of the catheter 90. The actuation rod 308 can be actuated, which can compress the biasing member 340 and reduce the longitudinal distance (L) between the proximal collar 330 and the distal collar 332. As a result, the lateral distance (d) between the first apex 314 and the second apex 324 increases to a lateral distance (d2), i.e., an elongated configuration, and the cross-sectional shape of the vessel 80 can be reshaped from a resting configuration to a flattened configuration. In embodiments, in the elongated configuration, the locking mechanism 350 can be engaged to prevent further longitudinal movement of one of the proximal collar 330 or the distal collar 332 to lock the vessel-shaping device 300 in the elongated configuration.

[0062] In embodiments, the actuation rod 308 is slidably engaged with the interior of the tubular member 302 and can withdraw the distal collar 332 proximally toward the proximal collar 330 to transition the vessel-shaping device 300 to the elongated configuration. In embodiments, the actuation rod 308 is slidably engaged with the exterior of the tubular member 302 and can advance the proximal collar 330 distally toward the distal collar 332 to transition the vessel-shaping device 300 to the elongated configuration. However, it should be appreciated that other combinations of the slidable actuation rod 308, the proximal collar 330, or the distal collar 332 are contemplated. In embodiments, the vessel-shaping device 300 can be selectively detached from the tubular member 302 to remain at the target location while the tubular member 302 and the catheter can be withdrawn.

[0063] In embodiments, the proximal end of the tubular member 302 can include a hand grip or similar structure configured to facilitate grasping and manipulation of the tubular member 302 and the vessel-shaping device 300 disposed at its distal end. Further, the hand grip can include one or more buttons, joysticks, or the like configured to actuate the actuation rod 308, the locking mechanism 350, or a combination thereof.

[0064] In an embodiment, the vessel shaping devices 100, 200, 300 disclosed herein can be formed from metals, alloys, superelastic alloys, stainless steel, Nitinol, plastics, polymers, carbon-based materials, carbon fibers, composite materials, combinations thereof, and the like. Advantageously, embodiments of the vessel shaping devices can be formed from materials that reduce thrombosis. In addition, embodiments of the vessel shaping devices provide a low-profile structure with reduced surface area to further reduce thrombosis. In an embodiment, embodiments of the vessel shaping devices or components thereof can include coatings, such as anti-thrombotic coatings, to further reduce thrombosis.

[0065] Although certain specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in certain detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adjustments and / or modifications may be made by those skilled in the art, and in broader aspects, these adjustments and / or modifications are also included. Therefore, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A blood flow regulating device for a blood vessel, comprising: a delivery catheter extending along a longitudinal axis; and a vessel reshaping device having a retracted configuration within the delivery catheter and an expanded configuration outside the delivery catheter, the vessel reshaping device being arranged to expand into the expanded configuration along a transverse axis perpendicular to the longitudinal axis of the delivery catheter to reshape the vessel into a flattened configuration, wherein the vessel shaping device comprises a frame including a first arm extending laterally outward from a central longitudinal axis to define a first vertex and a second arm extending laterally outward from the central longitudinal axis in an opposite direction to the first arm to define a second vertex, the proximal ends of the first arm and the proximal ends of the second arm being coupled to a proximal collar, and the distal ends of the first arm and the distal ends of the second arm being coupled to a distal collar, The vascular shaping device further comprises: a first stabilizing member extending from a proximal portion of the first arm across the first apex to a distal portion of the first arm; and A second stabilizing member extends from a proximal portion of the second arm across the second apex to a distal portion of the second arm.

2. The blood flow regulation device of claim 1, wherein the flattened configuration of the vessel defines an extended transverse diameter, a reduced lateral diameter, and a cross-sectional area that is smaller than the cross-sectional area of ​​the vessel in the resting configuration.

3. A blood flow regulation device according to claim 1 or 2, wherein the vascular shaping device is self-expanding to the expanded configuration.

4. The blood flow regulation device according to claim 3, wherein the vessel shaping device is formed of Nitinol.

5. The blood flow regulation device of claim 1, wherein the vessel shaping device further comprises a tubular member coupled to the frame.

6. The blood flow regulation device of claim 5, wherein the tubular member is fixedly attached to a distal collar and slidably engaged with the proximal collar, the distal collar defining an atraumatic tip.

7. The blood flow regulation device of claim 5, wherein the tubular member is slidably engaged with the distal collar and fixedly attached to the proximal collar, the distal end of the tubular member defining an atraumatic tip.

8. The blood flow regulation device of claim 5, wherein movement of the tubular member in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis.

9. The blood flow regulation device according to claim 5 further includes an actuator rod slidably engaged with the interior or exterior of the tubular member, wherein movement of the actuator rod in one of the proximal direction or the distal direction further causes the vascular shaping device to expand along the transverse axis.

10. The blood flow regulation device of claim 1, wherein the first stabilization member or the second stabilization member extends laterally inward toward the central longitudinal axis.

Images