The present disclosure relates generally to apparatuses and methods for treating vascular conditions, and more specifically, to apparatuses and methods for advancing a mechanism through a vessel.
Atherosclerosis and other occlusive diseases are prevalent among a significant portion of the population. In such diseases, atherosclerotic plaque forms within the walls of the vessel and blocks or restricts blood flow through the vessel. Atherosclerosis commonly affects the coronary arteries, the aorta, the iliofemoral arteries and the carotid arteries. Several serious conditions may result from the restricted blood flow, such as ischemic events.
Various procedures are known for treating stenoses in the arterial vasculature, such as the use of balloon angioplasty and stenting. During a balloon angioplasty procedure, a catheter having a deflated balloon attached thereto is positioned across a constricting lesion, and the balloon then is inflated to widen the lumen to partially or fully restore patency to the vessel.
Stenting involves the insertion of a usually tubular member into a vessel, and may be used alone or in conjunction with an angioplasty procedure. Stents may be self-expanding or balloon expandable. Self-expanding stents typically are delivered into a vessel within a delivery sheath, which constrains the stent prior to deployment. When the delivery sheath is retracted, the stent is allowed to radially expand to its predetermined shape. If the stent is balloon expandable, the stent typically is loaded onto a balloon of a catheter, inserted into a vessel, and the balloon is inflated to radially expand the stent.
Generally, during each of the foregoing interventional procedures, a wire guide is inserted into a patient's vessel, e.g., under fluoroscopic guidance. The wire guide then is advanced toward a target site in a patient's vasculature. For example, the proximal end of the wire guide may be advanced through a stenosis. Then, various medical components, such as a balloon catheter and/or stent, may be proximally advanced over the wire guide to the target site.
Various wire guides comprise flexible proximal regions to facilitate navigation through the tortuous anatomy of a patient's vessel, but such flexible proximal regions may be difficult to be advanced through an occlusion. However, if the proximal region of the wire guide is too rigid, then it may not be flexible enough to navigate the tortuous anatomy. It may be difficult to advance both relatively flexible and relatively rigid wire guides through an occlusion, particularly a narrow or hardened stenosis, by manually pushing from the distal end of the wire guide.
Because the control of movement and placement of medical devices within the body using wire guides relies on mechanical forces that are externally applied, the forces may not be accurately controlled and may potentially cause damage to a vessel wall. Additionally, an open access port for controlling a device may increase a chance of infection.
In order to further reduce the chance of damaging a vessel wall when moving a medical device in a vessel, a motorized apparatus and method for generating translational movement through a vessel without requiring a guidewire is described. The motorized apparatus may be powered by cyclic movement of fluids and/or powered electrically. The motorized apparatus may be wired or wireless and may transport medical devices, sensors or medications for diagnostic and/or therapeutic use.
According to one aspect, an apparatus suitable for translational movement through an interior of a vessel is described. The apparatus may include a flexible tube having a first end and a second end. A first vessel wall grappling member may be positioned on an exterior of the flexible tube adjacent the first end and a second vessel wall grappling member may be positioned on the exterior of the flexible tube adjacent the second end. The first and second wall grappling members are adapted to selectively expand to contact a vessel wall surrounding the flexible tube. An actuation mechanism may be positioned along at least a portion of a length of the flexible tube, where the actuation mechanism is configured to cooperate with the first and second vessel wall grappling members to effect movement of the flexible tube in at least one direction relative to the vessel wall.
According to another aspect, a method for moving a device through a passageway is provided. The method includes inserting the device into the passageway, the device having a hollow flexible tube with a first wall gripping member and a second wall gripping member, where each of the first and second wall gripping members are positioned at opposite ends of an outside portion of the hollow flexible tube. The method may further include expanding the first wall gripping member to an expanded state on a first end of the hollow flexible tube and extending the hollow flexible tube to an extended position while maintaining the first wall gripping member in the expanded state. After extending the hollow flexible tube, the method may include expanding a second wall gripping member to the expanded state on a second end of the hollow flexible tube and contracting the first wall gripping member to a contracted state. The method further includes retracting the hollow flexible tube to a retracted position while the second wall gripping device is in the expanded state and while the first wall gripping device is in the contracted state.
In yet another aspect, an apparatus is disclosed that is suitable for translational movement through an interior of a vessel. The apparatus may have a flexible body having a first end and a second end opposite the first end. A first wall contact actuator may be positioned on an exterior of the flexible body at the first end and configured to selectively contact the interior of the vessel. A second wall contact actuator may be positioned on the exterior of the flexible body at the second end, where the second wall contact actuator is configured to selectively contact the interior of the vessel. A body actuator may be mounted to the flexible body between the first and second wall contact actuators, the actuator configured to extend and contract a length of the flexible body. The first and second wall contact actuators and the body actuator are adapted for independent actuation to selectively move the flexible body along a longitudinal axis of the vessel.
Other systems, methods features and advantages will be, or will become, apparent to one of skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
In the present application, the term “distal” refers to a direction that is generally toward a physician during a medical procedure, while the term “proximal” refers to a direction that is generally toward a target site within a patient's anatomy during a medical procedure.
Referring now to
The translational actuator 16, also referred to herein as a body actuator, may be positioned on at least a portion of an exterior of the flexible tube 12. In other implementations, the translational actuator 16 may be positioned in the flexible tube 12 or may form part of the flexible tube 12. The flexible tube 12 may comprise a corrugated or bellows-like surface, in one implementation, to help the flexible tube 12 expand and contract along its longitudinal axis in cooperation with the translational actuator 16. Each of the first and second anchoring actuators 18, 20, also referred to herein as vessel wall grappling or gripping members, may be positioned on an outside of the flexible tube 12 and spaced apart from one another. In one implementation, as shown in
The translational actuator 16 may be configured to change in length from a first, minimal length state to a second, extended length state along a longitudinal axis of the flexible tube 12 in response to receipt of a remotely controlled input. The first and second actuators 18, 20 may each be configured to expand and contact an interior wall of a surrounding vessel V in a first state, as well as to contract and pull away from the interior wall of vessel V in a second state, in response to remotely controlled input. The translational actuator 16 and first and second actuators 18, 20 may all be independently actuated. As described in greater detail below, the translational actuator 16 and first and second anchoring actuators 18, 20 are configured to cooperate to effect translational movement of the apparatus 10 in either the proximal or distal direction along a vessel V without the need for first inserting a guide wire and without using a wire to mechanically push or pull the apparatus along the vessel.
In
The translational actuator 16 may be remotely controlled via one or more insulated input wires 22 that attach to the translational actuator 16 and may extend from the apparatus 10 through the vessel V to a voltage or current source (not shown) outside an entry point at a distal region of the vessel V. The translational actuator 16 may have its length changed from an initial, minimal length state, where no electrical stimulus is applied and the length of the actuator is at its minimum, to an extended length state, where electrical stimulus is applied such that the length of the actuator extends to an extended state where the length is greater that the length at the initial state. The change of length between states may be a fixed change of length, using a predetermined fixed voltage or current change, or may be variable over a predetermined range.
The example first and second anchoring actuators 18, 20 shown in
Although specific actuator mechanisms, electrical and fluid, are shown in the example of
Regardless of the particular configuration of actuators in the apparatus 10, it is contemplated that the apparatus may be injected, endovascularly delivered or otherwise surgically placed inside a vessel in a patient's body at an initial location and remotely controlled by electrical and/or fluid control to move itself to a desired location along the vessel V from that initial location.
Referring now to
In
Referring now to
In a next step, shown in
Referring now to
The process described in
Moreover, the apparatus 10 may be moved incrementally in a distal direction by reversing the steps described for
As noted above, the translational actuator 16 may be a piezoelectric actuator, which therefore undergoes a dimensional change when an electrical signal is applied. The dimensional change may be proportional to the voltage or current applied to the actuator. Accordingly, the provision of a variable voltage to the translational actuator 16 may impact the linear change associated with the translational actuator 16 and may affect the incremental linear movement of the apparatus.
In one implementation, the flexible tube 12 of the apparatus 10 is configured to provide a continuous unobstructed passage between the proximal and distal ends of the flexible tube 12 for a fluid to pass. In other words, the flexible tube 12 may provide passage for fluids at all actuation stages of the first and second anchoring actuators 18, 20, and of the translational actuator 16, shown in
In other implementations, the first and second anchoring actuators 18, 20 may be inflatable balloons that surround the flexible tube 12 but that do not completely block off fluid from passing outside the flexible tube 12 when actuated. For example, a version of an anchoring actuator 30 is shown in
The apparatus 10 may be used to treat a stenosis in the vessel or used to pull or position medical instruments, tools or even medications to a desired location in a vessel. The apparatus 10 may be inserted into the patient's vessel V and positioned proximal to a stenosis S in the manner described above with respect to
It will be apparent that while the embodiments have been described primarily with respect to advancing an apparatus having inflatable anchoring actuators and an electrically controllable translation actuator through a vessel. In various implementations, the apparatus is designed to, in an inch worm-like manner, propel itself through a vessel using fluid and/or electrical energy provided from remotely located sources. The remotely located sources of electrical energy and/or fluids may be linked to the apparatus via wires and fluid bearing tubes that extend to the entry point in the vessel. In instances where electrical energy is provided to the apparatus, the electrical energy may be provided wirelessly via an inductive energy transmitting device positioned outside of the vessel and or body of the patient.
By using adjustable actuators that grip the inside of the vessel walls, no guidewire insertion is needed and the navigation of the vessel may be made by the apparatus itself rather than being propelled by a mechanical force of a guide wire or by pulling along a guide wire previously manually threaded through a vessel. The use of a relatively autonomous vessel navigating apparatus such as described herein may contribute to shorter insertion times in certain applications as a separate initial guide wire insertion procedure is not required.
While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the invention. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
The foregoing description of the inventions has been presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the inventions to the precise forms disclosed. It will be apparent to those skilled in the art that the present inventions are susceptible of many variations and modifications coming within the scope of the following claims.
This application claims the benefit of U.S. Provisional Application Ser. No. 62/590,899, filed Nov. 27, 2017, and entitled “Device for Translational Movement Through Vessels,” the entirety of which is hereby incorporated herein by reference.
Number | Date | Country | |
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62590899 | Nov 2017 | US |