TECHNICAL FIELD

Embodiments of the present invention relate generally to medical devices and methods of using same, and more specifically, to medical devices for treating or treating an occluded biological lumen, such as an embolus or clot in a blood vessel.

BACKGROUND OF THE INVENTION

This section is intended to introduce various aspects of the art, which may be associated with exemplary embodiments of the present invention. This discussion is believed to assist in providing a framework to facilitate a better understanding of particular aspects of the present invention. Accordingly, it should be understood that this section should be read in this light, and not necessarily as any admission of prior art.

There are many reasons a blood vessel becomes blocked or obstructed. One common way is from deposition of thrombus or clot inside the lumen of the blood vessels which can restrict the antegrade blood flow through the lumens of these blood vessels to the body tissues. Because arterial blockages reduce blood flow through the affected vessel, any blockage or obstruction can lead to many serious medical complications as tissue relying on the blood's supply of oxygen may become damaged due to the decrease in the oxygen amount. For instance in the brain circulation this can lead to stroke with loss of vital brain functions and/or death, while in the heart it can lead heart attack due to damage of the heart muscle with significant impairment of its ability to pump blood to the body organ which can eventually lead to death.

While various methods and devices are available to treat a blockage or obstruction through removal of the obstructing clot, these devices can be traumatic to the blood vessel due to stiffness and pressure exerted on the lining of the vessel during clot engagement and removal. In addition, they usually do not sufficiently capture and retain the particulate matters from the obstruction. In particular, these methods usually cause fragmentation of the clot either during device engagement of the clot or due to the friction between the not fully encapsulated clot with the wall of the vessels or the flowing blood during the removal from the body. This fragmentation of the clot can lead to migrating of clot fragments with the blood flow either to the same treated blood vessels and its branches distal to the original obstruction site or to another unaffected area of the vascular system in the branching circulation at or proximal to the site of the obstruction where they can get lodged again and causes further obstruction. There remain a need for new devices to safely remove the obstructing clot fully encapsulated and shielded from the friction force with the blood vessel wall and the flowing blood to prevent excessive fragmentation and distal migration

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provides a minimally invasive endovascular device for treating a blocked or obstructed biological lumen, such as a blood vessel fully or partially obstructed by deposits of biological matters in or non-biological matters. Certain embodiments of the present invention comprise two capture members that are configured to be placed on either side of the obstruction and enclose around the obstruction for removal. Embodiments of the present invention also provide methods for implementing an endovascular device according to aspects of the present invention.

According to one aspect of the present invention, a device to remove an obstruction in a lumen is described. The device comprises a first capture member, a second capture member, where each capture member comprises an open end and a tapered end. The open end is defined by a frame component coupled to a body component, the body component extending between the open end and the tapered end. The device further comprises a first guide member coupled to the first capture member at the open end, where at least a portion of the body component is attached to the first guide member, and a second guide member coupled to the second capture member at the open, where at least a portion of the body component is attached to the second guide member, where the first capture member and the second capture member are slidably coupled to each other, the slidable coupling comprises the first guide member disposed in the second guide member.

In one embodiment, the device further comprises a radiopaque marker. In another embodiment, the frame component is configured to fit within a catheter for delivery to the obstruction and to expand to define the open end when released from the catheter, the catheter having a radius smaller than a radius of the open end. In one embodiment, the frame component comprises a self-expanding material configured to have an original configuration and a deformed configuration; where the self-expanding material is configured to change from the deformed configuration to the original configuration at least by exposure to an activating condition. In another embodiment, the deformed configuration allows the device to fit within the catheter.

In one embodiment, the body component is attached to the respective guide member substantially along the length of the body component. In another embodiment, at least one capture member further comprises a support arm coupled to the respective guide member and the respective frame component. In one embodiment, the support arm comprises a first end and a second end, where the first end is coupled to the respective frame component and the second end is coupled to the respective guide member. In another embodiment, the second end is attached to the respective guide member. In another embodiment, the respective guide member further comprises a fastening member slidably coupled to the respective guide member and where the second end is attached to the fastening member.

In one embodiment, the body component is fluid impermeable. In another embodiment, the body component comprises a woven material of at least one of the following: a polymer, a methal, and any combination thereof. In another embodiment, the body component covers at least a portion of a surface of the frame component to which the body component is coupled. In another embodiment, at least one guide member is adapted to provide a suctioning force.

In one embodiment, the diameter of one frame component is smaller than the diameter of the other frame component. In another embodiment, at least one frame component comprises an inflatable member. In another embodiment, the device further comprises an inflatable member disposed near at least one frame component.

In one embodiment, at least one guide member comprises a body with a channel disposed therein, the body having at least one aperture positioned near an end near the respective capture member. In one embodiment, the guide member is used to provide a suctioning force. In one embodiment, the guide member is used to deliver a therapeutic substance to the obstruction. In another embodiment, the coupling between at least one guide member and the respective frame member comprises the at least one guide member attached to an outer surface of the respective frame member.

According to another aspect of the present invention, there is provided a method for removing an obstruction in a lumen. The method comprises the steps of delivering an endovascular device to the location of the obstruction in a patient using a catheter, where the device comprises a first capture member and a second capture member, where each capture member comprises an open end and a tapered end, where the open end comprises a frame component coupled to a body component, the body component extending between the open end and the tapered end. The device further comprises a first guide member coupled to the first capture member at the open end and along at least a portion of the body component, and a second guide member coupled to the second capture member at the open end and along at least a portion of the body component, where the first capture member and the second capture member are slidably coupled to each other, the slidable coupling comprises the first guide member disposed in the second guide member. The method further comprises the steps of positioning a distal end of the catheter distal to the obstruction, withdrawing the catheter to release the first capture member distal to the obstruction; positioning the distal end of the catheter proximal to the obstruction; withdrawing the catheter to release the second capture member proximal to the obstruction; enclosing the obstruction with the capture members by manipulating at least one of the first guide member or the second guide member to unite the capture members; and removing the captured obstruction by removing the united capture members from the lumen.

In one embodiment, the method further comprises the step of providing a suctioning force through at least one guide member. In another embodiment, the method further comprises the step of repeatedly moving at least one frame member against the obstruction. In another embodiment, the method further comprises the step of delivering a therapeutic substance to the obstruction. In one embodiment, the delivering is achieved at least through one of the guide members, the guide member comprising a body with a channel disposed therein, the body having at least one aperture positioned near an end near the respective capture member.

In one embodiment, the enclosing step comprises manipulating the first guide member to engage a surface of the first capture member with a surface of the obstruction while the second guide member is maintained stationary. In another embodiment, the enclosing step comprises manipulating the second guide member to engage a surface of the second capture member with a surface of the obstruction while the first guide member is maintained stationary. In another embodiment, the enclosing step comprises manipulating both the first and second guide members to engage a surface of both capture members with a surface of the obstruction.

The foregoing has outlined rather broadly the features and technical advantages of the embodiments of the present disclosure in order that the detailed description of these embodiments that follows may be better understood. Additional features and advantages of the embodiments of the present disclosure will be described hereinafter which form the subject of the claims of the present disclosure. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the present disclosure as set forth in the appended claims. The novel features which are believed to be characteristic of the present disclosure, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present disclosure.

