US-12616499-B2 - Systems and methods for endoluminal valve creation

Abstract

Medical systems, devices and methods for creation of autologous tissue valves within a mammalian body are disclosed. One example of a device for creating a valve flap from a vessel wall includes an elongate tubular structure having a proximal portion and a distal portion and a longitudinal axis; a first lumen having a first exit port located on the distal portion of the elongate tubular structure; a second lumen having a second exit port located on the distal portion of the elongate tubular structure; a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the first exit port; and an open trough on the recessed distal surface extending longitudinally from the first exit port.

Inventors

• Fletcher T. Wilson
• Douglas Sutton
• Christopher Scott Jones
• Benjamin K. CLINE
• Mariel Fabro

Assignees

• INTERVENE, INC.

Dates

Publication Date

20260505

Application Date

20231010

Claims (16)

1. 1 . A system for delivering fluid to a space within a blood vessel wall, the system comprising: a catheter device, comprising: a distal portion configured to be intravascularly positioned adjacent to the blood vessel wall, wherein the distal portion includes an open trough extending distally in a longitudinal direction at the distal portion and a tissue engagement surface extending along a longitudinal segment of the open trough; a tool lumen extending through the catheter device and terminating at a first port proximal to the open trough; and a visualization lumen extending through the catheter device and into the distal portion, wherein the visualization lumen extends to a second port proximal to the open trough and positioned to direct the visualization device into the open trough, wherein the visualization lumen and the open trough are configured to allow a visualization device to visualize tissue in the blood vessel wall adjacent to the tissue engagement surface, and wherein the open trough is configured to guide the visualization device in a longitudinal direction; and a tool configured to advance through the tool lumen and out of the first port to access the space in the blood vessel wall, wherein the tool includes a lumen to deliver fluid to the space within the blood vessel wall.
2. 2 . The system of claim 1 wherein the tissue engagement surface is configured to press against an opposing portion of the blood vessel wall and define at least a portion of a periphery of the space within the blood vessel wall.
3. 3 . The system of claim 1 wherein the open trough comprises a bottom portion and sidewalls that extend from the bottom portion to the tissue engagement surface, and wherein at least a portion of the bottom portion is covered by a transparent viewing window for the visualization device to visualize the tissue in the blood vessel wall.
4. 4 . The system of claim 1 wherein at least a portion of the first port is at an elevation corresponding to an elevation of the tissue engagement surface.
5. 5 . The system of claim 1 wherein the tool is a puncture element configured to advance through the first port and puncture the blood vessel wall to access the space within the blood vessel wall.
6. 6 . The system of claim 1 wherein a top-most edge of the visualization lumen at the distal portion is at an elevation that is aligned with or below the tissue engagement surface.
7. 7 . A system for visualizing a delivery of fluid to a space within a blood vessel wall, the system comprising: an elongated shaft, comprising: a distal portion configured to be intravascularly positioned adjacent to the blood vessel wall, wherein the distal portion has a sloped surface, a tissue engagement surface extending distally in a longitudinal direction from the sloped surface, and a trough extending distally from the sloped surface in the longitudinal direction, wherein the trough comprises a bottom portion and sidewalls extending between the bottom portion to the tissue engagement surface so that the bottom portion is open to the blood vessel wall; a tool lumen extending through the elongated shaft and terminating at an exit port proximal to the tissue engagement surface; and a visualization lumen extending through the elongated shaft and into the distal portion, wherein the visualization lumen is configured to guide a visualization device to the distal portion to visualize tissue in the blood vessel wall adjacent to the tissue engagement surface, and wherein the visualization lumen and the trough are configured to guide the visualization device to visualize tissue in the blood vessel wall adjacent to the tissue engagement surface; and a fluid delivery tool configured to advance through the tool lumen and distally from the exit port to access the space in the blood vessel wall, wherein the fluid delivery tool includes a fluid lumen to deliver the fluid to the space within the blood vessel wall.
8. 8 . The system of claim 7 wherein the tissue engagement surface comprises a transparent material providing a window between the visualization lumen and the blood vessel wall adjacent to the tissue engagement surface.
9. 9 . The system of claim 7 wherein the distal portion of the elongated shaft further comprises an expandable member positioned circumferentially opposite the tissue engagement surface, and wherein the expandable member is positioned to press the sloped surface and the tissue engagement surface into contact with the blood vessel wall.
10. 10 . The system of claim 9 wherein expansion of the expandable member is configured to cause the tissue engagement surface to contact a first segment of the blood vessel wall such that the first segment of the blood vessel wall is at a different elevation with respect to a second segment of the blood vessel wall in contact with the sloped surface.
11. 11 . The system of claim 9 wherein expansion of the expandable member is configured to cause the tissue engagement surface to contact a first segment of the blood vessel wall and position the exit port to direct the fluid delivery tool into the first segment of the blood vessel wall to access the space within the blood vessel wall.
12. 12 . The system of claim 7 wherein the fluid delivery tool is configured to eject the fluid as the fluid delivery tool advances out of the exit port and into the space within the blood vessel wall.
13. 13 . A device for delivering a fluid to a space within a blood vessel wall, the device comprising: a catheter shaft having a distal portion configured to be intravascularly positioned adjacent to the space within the blood vessel wall, wherein the distal portion comprises: a sloped surface at an angle with respect to a longitudinal axis of the distal portion; a tissue engagement surface extending distally from the sloped surface along the longitudinal axis of the distal portion; a trough formed in the tissue engagement surface, wherein the trough is open to the blood vessel wall and positioned to define at least a portion of a periphery of the space when the distal portion is pressed against the blood vessel wall; and a first port positioned along at least a portion of the sloped surface; a first lumen extending through the catheter shaft and terminating at the first port of the distal portion, wherein the first lumen and the first port are positioned to direct a fluid delivery tool into the space when the distal portion is pressed against the blood vessel wall; and a second lumen extending through the catheter shaft and terminating at a second port open to the trough, wherein the second lumen is positioned to direct an imaging device adjacent to the space when the distal portion is pressed against the blood vessel wall to image the space within the blood vessel wall, and wherein the trough is configured to guide the imaging device while imaging the space within the blood vessel wall.
14. 14 . The device of claim 13 , further comprising an expandable component carried by the distal portion of the catheter shaft, wherein the expandable component is positioned circumferentially opposite the sloped surface and the tissue engagement surface to press the sloped surface and the tissue engagement surface into contact with the blood vessel wall.
15. 15 . The device of claim 13 wherein the first port is positioned to direct the fluid delivery tool distally at an elevation above the tissue engagement surface to access the space within the blood vessel wall.
16. 16 . The device of claim 13 wherein the fluid delivery tool is a puncture element configured to move distally out of the first port and penetrate the blood vessel wall to access and create the space within the blood vessel wall.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/936,155, filed Jul. 22, 2020, now U.S. Pat. No. 11,812,990, which is a continuation of U.S. patent application Ser. No. 16/383,504, filed Apr. 12, 2019, now U.S. Pat. No. 10,758,335, which is a divisional of U.S. patent application Ser. No. 14/377,492, filed Aug. 7, 2014, now U.S. Pat. No. 10,292,807, which is a 35 U.S.C. § 371 U.S. national phase application of International Application No. PCT/US2013/025196, filed Feb. 7, 2013, which claims the benefit of U.S. Provisional Application No. 61/596,190, filed Feb. 7, 2012, and U.S. Provisional Application No. 61/665,295 filed Jun. 27, 2012, all of which are hereby incorporated by reference in their entireties for all purposes. INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. TECHNICAL FIELD Embodiments of the present invention relate generally to medical systems, devices and methods for creation of autologous tissue valves within a mammalian body. BACKGROUND Venous reflux is a medical condition affecting the circulation of blood, such as in the lower extremities or neck. The valves in the vessel that normally force blood back towards the heart cannot function properly. As a result, blood flows backwards, causing unwanted clinical problems such as ulceration or even multiple sclerosis when chronic cerebrospinal venous insufficiency is present. Applicant of the subject application determines that new systems and methods for treating venous reflux would be desirable. SUMMARY The present invention relates generally to medical systems, devices and methods for creation of autologous tissue valves within a mammalian body. In some embodiments, a device for accessing a valve creation site on a vessel wall is provided. The device can include a handle; an elongate tubular structure having a proximal end and a distal end, wherein the proximal end of the elongate tubular structure is attached to the handle, wherein the elongate tubular structure is sized and configured for insertion into a vessel of a patient; and a valve navigation mechanism extending from the distal end of the elongate tubular structure, wherein the valve navigation mechanism has a smaller cross-sectional profile than the elongate tubular structure. In some embodiments, the handle has a configuration that doubles back towards the distal end of the elongate tubular structure. In some embodiments, the valve navigation mechanism is thinner and has a smaller diameter than the elongate tubular structure. In some embodiments, the valve navigation mechanism is more flexible than the elongate tubular structure. In some embodiments, the valve navigation mechanism has an elongate body that is curved along its length. In some embodiments, the valve navigation mechanism has an atraumatic tip. In some embodiments, the device further includes a tool lumen extending through the elongate tubular structure, the tool lumen having an exit port located on a first side of a distal portion of the elongate tubular structure. In some embodiments, the device further includes an expansion element aligned with the exit port and located a second side of the distal portion of the elongate tubular structure, wherein the first side is opposite the second side. In some embodiments, the device further includes a predetermined off-set between the exit port and a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the exit port. In some embodiments, the recessed distal surface is flat. In some embodiments, the off-set is ramped. In some embodiments, the off-set is less than 2 mm. In some embodiments, the device further includes a puncture element extending out of the exit port, wherein the predetermined offset is configured to control the depth of penetration of the puncture element into the vessel wall, wherein the depth of penetration is less than the thickness of the vessel wall. In some embodiments, the puncture element comprises an expansion mechanism. In some embodiments, the expansion mechanism is a balloon. In some embodiments, the puncture element has an asymmetrical tip. In some embodiments, a device for creating a valve flap from a vessel wall is provided. The device can include an elongate tubular structure having a proximal portion and a distal portion and a longitudinal axis; a first lumen having a first exit port located on the distal portion of the elongate tubular structure; a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the first exit port; and a visualization window located on the recessed di