JP2015505250A - Clot removal apparatus and method - Google Patents

Abstract

A clot removal apparatus and method for removing a clot from a blood vessel can include an expandable clot engagement element, an expandable clot capture element, and a sheath surrounding and compressing the capture element and engagement element. . The sheath can be removable so that the capture element can be expanded within the vessel in which the sheath is deployed and the engagement element can be expanded within the capture element. Furthermore, the clot removal apparatus and method for removing a clot from a blood vessel can use a tubular clot capture element to deploy within the blood vessel to surround the clot, thus the clot capture element surrounds the clot, And when retracted in the longitudinal direction of the vessel, the clot capture element is configured to apply a radially inward compressive force to the clot. Further, the clot removal apparatus and method can include a tubular clot capture element having a first inner diameter and a clot engagement element having a second outer diameter. The first diameter and the second diameter can be selected such that the clot engagement element can rotate within the tubular clot capture element. Furthermore, the clot removal apparatus and method can use a shaft and a clot engagement element at the end of the shaft, both configured to deploy within a blood vessel. The clot removal device can also include a stabilizer configured to at least partially surround the shaft and maintain a portion of the shaft in a non-contact relationship with the vessel wall.

Description

  Embodiments of the present disclosure generally relate to devices and methods for treating occlusions in the vascular system. More particularly, embodiments of the present disclosure relate to devices and methods for removing clots (eg, emboli and blood clots) found specifically in blood vessels.

  Blood clots (eg, emboli and thrombi) are examples of obstructions that can form in mammalian blood vessels. A clot in an individual's blood vessel can be dangerous when it disrupts blood flow, thereby placing the individual at risk for medical traumas such as a stroke or heart attack. . Therefore, it may be necessary to remove clots that remain in the blood vessels.

  Various devices and procedures have been used to remove clots from blood vessels. For example, a catheter with a balloon at its distal end can be inserted into the blood vessel and allowed to pass through the clot after the balloon is inflated. The balloon can then be withdrawn from the blood vessel to remove the clot.

  Another example of a clot removal device is a catheter that includes a helical section at its distal end. A catheter having a helical section can be delivered to a clot site within a blood vessel and then cut into the clot using the helical section. Thus, the helical section can grip the inner portion of the clot before withdrawing the clot from the blood vessel.

  One danger that arises with a clot removal device is that a portion of the clot can break during the removal process, moving through the vasculature and causing traumatic damage. This can occur for a variety of reasons. For example, when the clot removing device passes the clot before deployment, the clot may be broken and the portion may be destroyed by the operation that is deployed in advance. In addition, the risk of deploying the device in a distant distal region is also increased. There is a need for an apparatus and method that allows removal of a clot from a blood vessel while reducing the likelihood that a portion of the clot or clot will move during the removal process, creating additional risk to the patient.

  Embodiments of the present disclosure provide an apparatus and method for removing clots from blood vessels.

  A first aspect of the invention provides a clot removal device, the device being an expandable clot engagement element, an expandable clot capture element, and a sheath surrounding and compressing the capture element and engagement element. The sheath is removable and thereby comprises a sheath that allows the capture element to expand within the vessel in which the sheath is deployed and allows the engagement element to expand within the capture element.

  In some embodiments, the capture element surrounds the engagement element and / or the capture element includes a mesh-like structure and / or the capture element has a longer length than the engagement element and / or capture The element is sized to engage the vessel wall when deployed, and the engagement element is dimensioned to be movable within the capture element when deployed.

  In some embodiments, the engagement element is a coil and / or the engagement element is dimensioned to move within the capture element when the sheath is removed and / or the engagement element is Sized to allow rotation within the capture element once the sheath is removed.

  The capture element and the engagement element, when used, can be configured such that the engagement element is between the capture element and the clot.

  The apparatus can further comprise a locking mechanism for locking the clot engagement element within the clot capture element.

  A second aspect of the invention provides a method for removing a clot from a blood vessel, the method comprising deploying the clot removal device to a clot site within the blood vessel, wherein the clot removal device is expandable clot engagement. A step including an element, an expandable clot capture element, and a sheath surrounding and compressing the capture element and the engagement element such that the capture element expands within the blood vessel and the engagement element expands within the capture element Removing the sheath from the capture element and the engagement element.

  The method according to the second aspect of the invention can be performed using any embodiment of the apparatus according to the first aspect described above.

  In some embodiments, upon removal of the sheath, the engagement element moves within the capture element and / or upon removal of the sheath, the engagement element rotates within the capture element.

  In some embodiments, the method also includes using a locking mechanism to lock the clot engagement element within the clot capture element.

  In some embodiments of the method, the capture element engages the vessel wall in the deployed state, and the engagement element moves within the capture element in the deployed state.

  A third aspect of the present invention provides a clot removal device comprising a tubular clot capture element, wherein the clot capture element is configured to deploy within a blood vessel to enclose the clot, the clot capture element comprising a clot engagement element. The clot capture element is configured to radially contract when retracted, so that the clot capture element surrounds the clot and the length of the vessel When retracted in the direction, the clot capture element is configured to apply a radially inward compressive force against the clot.

  In some embodiments, the clot capture element is in the form of a mesh-like structure such as a net. The net can be braided and / or the net includes a plurality of intersecting braids and each of the plurality of intersecting braids is movable relative to each other and / or the net is A plurality of wires, a proximal end, and a distal end can be included, and the proximal and distal ends do not have an open end of the wire.

  In some embodiments, the clot engagement element includes a coil and a shaft connected to the coil.

  In some embodiments, the apparatus according to the third aspect of the present invention further comprises a control shaft, the clot capture element includes a proximal end and a distal end, and the control shaft extends from the proximal end. .

  In some embodiments, the control shaft and clot capture element are configured such that when the control shaft is retracted in the longitudinal direction of the blood vessel, the clot capture element is retracted in the longitudinal direction of the blood vessel.

  In some embodiments, the clot capture element is configured to apply a longitudinal shear force to the clot when retracted in the longitudinal direction of the blood vessel.

  A fourth aspect of the invention provides a method of removing a clot from a blood vessel, the method comprising deploying a tubular clot capture element into the blood vessel, the clot capture element receiving the clot engagement element and A step having a guide opening, a step of enclosing the clot with the clot capture element, and the clot capture element contracting radially and applying a radially inward compressive force against the clot. Retreating in the longitudinal direction.

  In some embodiments, the method according to the fourth aspect can be performed using an apparatus according to the third aspect of the present invention.

  In some embodiments of the method, the clot capture element is retracted by a control shaft extending from the clot capture element.

  In some embodiments, retracting the clot capture element in the longitudinal direction of the blood vessel includes applying a longitudinal shear to the clot.

  A fifth aspect of the present invention provides a clot removal apparatus, the apparatus comprising a tubular clot capture element having a first inner diameter and a clot engagement element having a second outer diameter, The diameter and the second diameter are selected so that the clot engagement element can be rotated within the tubular clot capture element.

  In some embodiments, the tubular clot capture element includes a mesh-like structure.

  In some embodiments, the clot engagement element includes a coil.

  If the tubular clot capture element includes a mesh-like structure and the clot engaging element includes a coil, the coil can be configured to rotate about the outside of the clot, and the mesh-like structure can be configured with the coil and clot. It can comprise so that it may contain.

  In some embodiments, the first diameter and the second diameter are selected such that the outer surface area of the clot engagement element contacts the inner surface area of the clot capture element and / or the first diameter. And the second diameter is selected such that the clot engagement element can move longitudinally within the clot capture element and / or the first diameter and the second diameter are selected by the clot engagement element. Selected so that it can be expanded within the element.

  In some embodiments, the apparatus according to the fifth embodiment of the present invention further comprises a locking mechanism for locking the clot engagement element within the clot capture element.

  In some embodiments, an apparatus according to a fifth embodiment of the present invention comprises a first shaft extending from the proximal end of the clot capture element and a second shaft extending from the proximal end of the clot engaging element. In addition, the second shaft is configured to rotate within the first shaft.

  A sixth aspect of the invention provides a method for removing a clot from a blood vessel, the method having a step of delivering a tubular clot capture element having a first diameter to the clot site and a second outer diameter. Delivering the clot engagement element to the clot site, wherein the first diameter and the second diameter are selected such that the clot engagement element rotates within the tubular clot capture element.

  In some embodiments, the method according to the sixth aspect of the invention may be performed by an apparatus according to the fifth aspect of the invention.

  In some embodiments, a locking mechanism locks the clot engagement element within the clot capture element.

  In some embodiments, the method according to the sixth aspect of the present invention may further comprise the step of moving the clot engagement element longitudinally within the clot capture element.

  In some embodiments, the method according to the sixth aspect of the present invention may further comprise expanding the clot engagement element within the clot capture element.

  In some embodiments, the first shaft extends from the proximal end of the clot capture element and the second shaft extends from the proximal end of the clot engagement element, and the method includes connecting the second shaft to the first shaft. The method further includes rotating within one shaft.

  A seventh aspect of the invention provides a clot removal device, wherein the device is a shaft and a clot engagement element at the end of the shaft, the clot engagement element and the shaft configured to deploy within a blood vessel. A clot engaging element and a stabilizer configured to at least partially surround the shaft and to maintain a portion of the shaft in a non-contact relationship with the vessel wall.

  In some embodiments, the clot engagement element is a coil. The coil can include a plurality of windings having a substantially constant pitch and / or the coil can include a plurality of windings having a substantially constant radius.

  In some embodiments, the stabilizer is configured to maintain the coil generally axially within the blood vessel.

  In some examples, the apparatus according to the seventh aspect may further comprise a clot capture element. The stabilizer can be connected to a clot capture element and / or the clot capture element is a mesh tube, and the stabilizer includes an opening at the end of the mesh tube, and / or Alternatively, the stabilizer includes a portion of the control shaft that extends from the proximal end of the clot capture element.

  An eighth embodiment of the present invention provides a clot removal device, the device being a clot engagement element at the end of the shaft, including a shaft and a rotatable coil, the coil extending from the shaft; A stabilizer comprising a clot engaging element and an opening through which the shaft passes, wherein the shaft and coil are configured to be deployed within the blood vessel, maintaining the shaft generally at the center of the blood vessel during rotation of the coil. And a stabilizer configured to.

  In some embodiments, the stabilizer includes a tube with a tapered end and the opening is located at the tapered end. The tube can be made from a mesh-like structure. The mesh-like structure can be configured such that when the tube is retracted in the longitudinal direction of the blood vessel, it contracts radially.

  A ninth aspect of the present invention provides a method for removing a clot from a blood vessel, the method deploying a clot engaging element located at the end of the shaft into the blood vessel, and at least partially And deploying the stabilizer within the vessel to maintain a portion of the shaft in a non-contact relationship with the vessel wall.

  In some embodiments of the ninth aspect, the method further comprises disposing a stabilizer at a location adjacent to the clot engagement element, and the stabilizer substantially includes the clot engagement element within the blood vessel. And optionally, the method further comprises the step of rotating the clot engagement element about the clot while substantially centering the clot engagement element with the stabilizer. .

  The method according to the ninth aspect of the present invention can be carried out using the apparatus according to the eighth aspect of the present invention.

  In some embodiments, the stabilizer maintains the coil generally in the axial direction of the blood vessel.

  In some embodiments, the method according to the ninth aspect of the present invention can further comprise deploying the clot capture element within the blood vessel, and the stabilizer is connected to the clot capture element.

  Additional aspects of the present disclosure are set forth in part in the following description, and in part can be readily ascertained from the description, but may be learned by practicing the disclosure.

  It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.

  The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

1 is a cross-sectional view of a medical device for removing a clot from a blood vessel, consistent with embodiments of the present disclosure. FIG. 1B is a cross-sectional view of the medical device of FIG. 1A in an enlarged configuration. FIG. 1B is a cross-sectional view of the medical device of FIG. 1A in an enlarged configuration. FIG. 1B is a perspective view of a clot capture element and clot engagement element of the medical device of FIG. 1A. FIG. FIG. 6 is a perspective view of a clot capture element consistent with a second embodiment of the present disclosure in a contracted configuration. FIG. 6 is a perspective view of a clot capture element consistent with a second embodiment of the present disclosure in an expanded configuration. FIG. 6 is a perspective view of a clot capture element consistent with a third embodiment of the present disclosure. FIG. 6 is a perspective view of a clot capture element consistent with a fourth embodiment of the present disclosure. 1B is a perspective view of a conventional fixation mechanism for use with the medical device of FIG. 1A. FIG. 1B is a cross-sectional view of a body part showing steps of a method for removing a clot from the body part using the medical device of FIG. 1A. FIG. 1B is a cross-sectional view of a body part showing steps of a method for removing a clot from the body part using the medical device of FIG. 1A. FIG. 6B is a cross-sectional view of the body portion of FIGS. 6A-6B illustrating movement of the clot engagement element in a method of removing a clot from the body portion using the medical device of FIG. 1A. FIG. 6B is a cross-sectional view of the body portion of FIGS. 6A-6B illustrating movement of the clot engagement element in a method of removing a clot from the body portion using the medical device of FIG. 1A. FIG. FIG. 6B is a cross-sectional view of the body part of FIGS. 6A-6B showing the steps of removing the clot from the body part using the medical device of FIG. 1A. FIG. 6B is a cross-sectional view of the body part of FIGS. 6A-6B showing the steps of removing the clot from the body part using the medical device of FIG. 1A. 6B is a cross-sectional view of the body portion of FIGS. 6A-6B illustrating the forces acting on the clot during the method of removing the clot from the body portion using the medical device of FIG. 1A.

  Reference will now be made in detail to the exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

  Embodiments of the present disclosure generally relate to medical devices and methods for treating blockages in the body. More particularly, embodiments of the present disclosure relate to devices and methods for removing, but not limited to, clots including emboli and thrombi from blood vessels. However, it should be emphasized that the embodiments of the present disclosure can also be used in other medical procedures where it is desirable to remove obstructions or foreign bodies.

  According to embodiments of the present disclosure, a clot removal device including an expandable clot engagement element can be provided. The expandable clot engagement element, when deployed in a blood vessel, can grab, grasp, surround or hold and / or retrieve a clot or other obstacle.

  FIG. 1A shows one example of a clot engagement element 102 in connection with an exemplary clot removal device 100. In this disclosure, “proximal” refers to the end that is close to the operator of the device during use, and “distal” refers to the end that is remote from the operator of the device during use.

  As shown in FIG. 1B, in one embodiment, the clot engagement element 102 can include a coil with one or more windings 108. The winding 108 can be angled with respect to the longitudinal axis 1006 of the blood vessel 1002 (FIG. 7A). The angle of winding 108 can range from about 0 degrees to about 180 degrees, more preferably from about 90 degrees to about 180 degrees.

  The plurality of windings 108 can further form a helical configuration, whereby the plurality of windings 108 can have a substantially constant pitch P and / or substantially as indicated by the reference line in FIG. 7A. A constant radius R is shared. Thus, while rotating, adjacent windings having the same radius and pitch will follow substantially the same rotational path. Alternatively, the one or more windings 108 can include a variable pitch and / or a variable radius. The one or more windings 108 can be of any shape and / or configuration so that they rotate around a clot that remains in the blood vessel and grip at least a portion of the outer circumference of the clot, And it can be configured to separate the clot from the blood vessel (FIG. 6B). For example, the one or more windings 108 can be wound in any suitable shape including, but not limited to, a circle or an ellipse. One or more windings 108 can also be a continuous piece of material. The continuous piece of material can have any suitable cross-sectional shape including, but not limited to, a circle, ellipse, polygon, or any other shape that can be rolled.

  The one or more windings 108 may further include an atraumatic bottom or clot contact surface that may be substantially flat or rounded. The bottom of one or more windings 108, i.e., the clot contact surface, can reduce the tendency of the clot 1000 to break into multiple portions when contacted. Further, the bottom of one or more windings 108, i.e., the clot contact surface, can be textured to enhance the grip of the clot 1000. The top, or outer surface, of the one or more windings 108 can also be an atraumatic surface. The atraumatic top, or outer surface, of the one or more windings 108 can reduce damage to the tissue that the one or more windings 108 may contact at the clot site. The winding 108 can also include a coating on its top and / or bottom surface. The coating can include, but is not limited to, a lubricant and / or anesthetic.

  The clot engagement element 102 can further be a spring-like member configured to self-expand and contract. Expansion and contraction can be longitudinal and / or radial. Accordingly, the clot engagement element 102 can include a contracted configuration (FIG. 1A) and an expanded configuration (FIG. 1B). The contracted configuration can be maintained when the sheath 118 substantially surrounds the outer surface of the clot engagement element 102. An expanded configuration may be achieved when the sheath 118 is removed from at least a portion of the outer surface of the clot engagement element 102 (the sheath 118 will be discussed in further detail below).

  The clot engagement element 102 can be configured to expand to approximately the inner diameter of the blood vessel 1002 (FIG. 7A). Enlarging to approximately the inner diameter of the blood vessel 1002 can result in (but not necessarily) the clot engagement element 102 applying a force against the wall 1004 of the blood vessel 1002. When a force is applied to the vessel wall 1004, the force can cause the clot 1000 to separate from the vessel 1002 wall 1004. In many instances, the clot 1000 may be present in the vessel 1002, so the resulting separation should be beneficial. Thus, separating the clot 1000 from the vessel wall 1004 reduces the amount of force required to further remove the clot 1000 from the vessel 1002, and the clot 1000 can have multiple fragments during removal from the vessel 1002. The tendency to break down can be reduced.

  The shaft 116 can extend from the proximal end of the clot engagement element 102. The shaft 116 may be an elongate member configured to control the rotation and longitudinal movement of the clot engagement element 102. For example, as shown in FIG. 7A, the clot engagement element 102 can be moved in the direction of arrow 1010 'by moving shaft 116 in the direction indicated by arrow 1010. Further, when the shaft 116 is rotated in the direction of the arrow 1012, the clot engaging element 102 can be rotated in the direction of the arrow 1012 ′.

  The shaft 116 can have any shape and / or configuration as long as the shaft 116 can be configured to rotate and advance the clot engagement element 102. Further, the shaft 116 can have any suitable cross-sectional shape as long as the shaft 116 can be configured to rotate (FIG. 7A).

  The previous embodiment shows an example of the clot engagement element 102 as a wound structure, but in a broader sense, the clot engagement element can be of any shape as long as it can grip and remove the clot from the blood vessel. And / or can have a configuration. Further, the clot engagement element can be of any dimension that can be advanced through the lumen of the blood vessel.

  The clot engagement element can be composed of any suitable biocompatible material that is flexible and / or rigid enough to travel through the lumen of a blood vessel. Biocompatible materials may include, but are not limited to, synthetic plastics, stainless steel, ePTFE, PTFE, metal-polymer composites, and metal alloys of nickel, titanium, nickel titanium, copper cobalt, chromium, and iron. it can.

  In a broader embodiment of the present disclosure, the clot engagement element can include any structure or mechanism that can engage a clot or other obstacle. For example, the clot engagement element includes one or more hooks, forceps, an expandable cage, an expandable balloon, or a thermal or chemical mechanism for connecting a mechanical structure with the clot or obstacle. Can do.

  According to at least some embodiments of the present disclosure, an expandable clot capture element can be provided. The expandable clot engagement element can be any structure that can capture the clot engaged by the clot engagement element when deployed in a blood vessel.

  An exemplary clot capture element 104, consistent with an exemplary embodiment of the present disclosure, is shown in FIG. The clot capture element 104 can be configured to allow the clot engagement element 102 to be moved therein when deployed in a blood vessel. For example, as described in more detail below, when the sheath 118 is removed, the clot engagement element 102 is configured to rotate, expand, and / or slide longitudinally within the clot capture element 104. can do.

  As shown in FIG. 1C, the clot capture element 104 can include, but is not limited to, a catheter having a proximal end 104a and a distal end 104b. The proximal end 104a and the distal end 104b can each include an opening 112. The openings 112 at the proximal end 104a and the distal end 104b can be in communication with the central lumen 110 in the clot capture element 104 (FIG. 1A). The central lumen 110 in the clot capture element 104 includes the clot engagement element 102 and, without limitation, an optional guidewire 120, vacuum source, illumination and / or imaging device, and tools for grasping the clot. Allows insertion of other components that can support medical procedures including.

  The clot capture element 104 can be further configured to expand and contract. Accordingly, the clot capture element 104 is configured to transition between a contracted configuration (FIG. 1A) and an expanded configuration (FIG. 1B), similar to a spring, in response to movement relative to the surrounding sheath 118. be able to. Similar to the clot engagement element 102, the clot capture element 104 can be configured to expand to a dimension that is substantially the same as the inner diameter of the blood vessel 1002 at the clot site. The expansion of the clot capture element 104 to the inner diameter of the vessel 1002 and the force applied to the vessel wall 1004 at the clot site can help separate the clot 1000 from the vessel 1002 wall 1004. Separation can reduce the force required to remove clot 1000 from vessel 1002. Separation can also help reduce the tendency of the clot 1000 to break into multiple parts while the clot 1000 is removed from the blood vessel 1002.

  The clot capture element 104 can be of any shape and / or configuration that can be advanced through the lumen of a blood vessel. In one example, the clot capture element 104 can be a hollow tube having a constant diameter. Alternatively, the clot capture element 104 can have a diameter that varies along its length. For example, as shown in FIG. 2, the clot capture element 104 has a diameter that tapers at the proximal end 104a so that the proximal end 104a is connected to the distal end of the control shaft 114. (Control shaft 114 shall be discussed in further detail below).

  The clot capture element 104 can be composed of any known, suitable biocompatible material that is flexible and / or rigid enough to travel through the lumen of a blood vessel. The biocompatible material of the clot capture element 104 can further include properties that allow the clot capture element 104 to expand and contract as previously discussed. Thus, biocompatible materials include, but are not limited to, synthetic plastics, silicone elastomers, thermoplastic elastomers, nickel-titanium, stainless steel, ePTFE, PTFE, polyimide, polyamide, HDPE, polypropylene, polyvinyl chloride, LDPE, Metal-polymer composites and metal alloys can be included.

  The clot capture element 104 can include a single biocompatible material or a combination of multiple biocompatible materials. In one example, the clot capture element 104 can include a variety of biocompatible materials, and therefore the type and characteristics of the biocompatible material depend on the location of the biocompatible material on the clot capture element 104. It may change. For example, the distal end 104b of the clot capture element 104 can include a material having spring-like properties. Such biocompatible materials can include, but are not limited to, polyurethane, low density polyethylene, polyvinyl chloride, nitinol, and THV.

  It may be desirable for the proximal end 104a of the clot capture element 104 to include a stiffer biocompatible material than that of the distal end 104b. The biocompatible material at the proximal end 104a of the clot capture element 104 can be of any suitable degree of stiffness as long as the clot capture element 104 can be configured to travel through the lumen of a blood vessel. Thus, the biocompatible material at the proximal end 104a of the clot capture element 104 includes, but is not limited to, polyimide, polyamide, high density polyethylene, polypropylene, polyvinyl chloride, PTFE, polysulfone, copolymers of the foregoing materials, and blends Alternatively, a mixture can be included.

  The clot capture element 104 can be a single structure formed from a continuous portion of material. Alternatively, as shown in FIG. 2, the clot capture element 104 can include a plurality of components 106. In one example, for example, the plurality of components 106 can include a plurality of braids entangled to form a mesh-like structure (FIG. 2). The plurality of braids 106 can be connected to each other by any known means. Alternatively, the mesh-like structure can be in the form of a net, and the plurality of braids 106 can intersect each other without being connected, so that the plurality of braids 106 are mutually connected. It can be configured to move against. Further, the plurality of braids 106 can include a plurality of wires. The wires can be bent to intersect to form a mesh-like structure so that there are no open ends of the wires at the proximal end 104a and the distal end 104b of the clot capture element 104 (FIG. 2). The absence of an open end can reduce trauma to the blood vessel. In other embodiments, a free open end can be used. In some of these embodiments, the open end can be bent slightly inward, or otherwise in a physical structure that minimizes vessel trauma.

  When a mesh-like structure is used in the clot capture element 104, the mesh is configured similar to a Chinese finger trap and the cylindrical structure is radially contracted by longitudinal contraction force. Can do.

  Thus, regardless of other structures that can be used, one embodiment of the present disclosure can simply include a tubular clot capture element, where the clot capture element is within the vessel to surround the clot. Configured to be deployed, the clot capture element having an opening configured to receive and guide the clot engagement element, the clot capture element configured to contract radially when retracted. Thus, when the clot capture element surrounds the clot and retracts in the longitudinal direction of the blood vessel, the clot capture element is configured to apply a radially inward compressive force against the clot.

  Thus, for example, one embodiment of the present disclosure may simply be the structure of the capture element 104 in FIG. 2, which is a mesh with an opening 112 at the proximal end 104a for receiving and guiding the shaft 116. It has a tubular shape formed from 106. As a result of the mesh-like structure, when retracted, the capture element 104 contracts radially inward.

  The mesh structure can be a net or can be a braid. The net itself can include a plurality of intersecting braids such that the intersecting braids are movable relative to one another. The net may also include a plurality of wires, in which case one or more of the proximal and distal ends of the capture element does not have an open end of the wire (eg, free of exposed wires). (See the distal end of the capture element 104 of FIG. 2, without the ends).

  3A-3B and 4A-4B illustrate an alternative to a mesh-like structure that can include any suitable self-expanding structure. For example, suitable self-expanding structures include, but are not limited to, rounded coils, flat ribbon shaped coils, multiple expandable rings (FIGS. 3A-3B), and / or stent-like structures (FIGS. 4A--4). 4B) can be included. The self-expanding structure can be further supported between multiple layers 306 (eg, polymers) of material that can provide a suitable structure for the clot capture element 104.

  The clot capture element 104 can further include an atraumatic exterior surface that can limit tissue damage when deployed at the clot site. The clot capture element 104 can also include a coating on its outer surface and / or inner surface. The coating can include an anesthetic and / or lubricant, which can aid in the deployment of the clot capture element 104 and the clot engagement element 102 and / or the clot engagement element 102 can be clot capture element 104. Can help you move within.

  As mentioned above, the proximal end 104a of the clot capture element 104 can be connected to the control shaft 114 (see, eg, FIG. 2). The control shaft 114 may be an elongate member configured to pull the clot capture element 104 into a contracted configuration. The elongate member of the control shaft 114 is hollow with a solid wall configuration, a braided wall configuration, a wound wall configuration, a hypotube (ie, a solid wall configuration with portions removed for easy deflection). Tube. The hollow tube can have an opening at each end so that the control shaft 114 can communicate with the central lumen 110 (FIG. 1) of the clot capture element 104. The control shaft 114 thereby allows the passage of tools including, but not limited to, a guide wire 120 and an instrument for engaging the clot 1000. The control shaft 114 can further pass the shaft 116 of the clot engagement element 102, for example, as shown in FIG. Alternatively, the control shaft 114 can be a solid configuration, and the shaft 116 can be disposed adjacent to the shaft 114 rather than through it.

  The shaft 116 can have a diameter that is less than the diameter of the control shaft 114, thereby allowing the clot engagement element 102 to move along the longitudinal axis of the clot capture element 104. The shaft 116 can also include an outer surface that minimizes friction. For example, the outer surface of the shaft 116 can be smooth and / or include a lubricious coating that allows the shaft 116 to slide relatively easily within the control shaft 114. The shaft 116 can further include a lumen therein. The lumen can be in communication with the clot capture element 104. The lumen can also communicate with a lumen 1008 within the blood vessel 1002 when the clot removal device 100 is delivered to the clot site. Thus, the lumen inserts a tool including, but not limited to, a guidewire 120, a suction device, an illumination device, an imaging device, and / or a tool suitable for grasping the clot, useful during a clot removal procedure. It can be so.

  The control shaft 114 can include a diameter sized to receive the shaft 116 to allow the clot engagement element 102 to move within the clot capture element 104 by moving the shaft 116. The shaft 116 can have a length that is longer than the control shaft 114 so that the control shaft 114 can at least partially surround the shaft 116 (FIG. 2) so that the operator of the device can The longitudinal direction and rotational movement of the clot engaging element 102 can be controlled. The control shaft 114 can be further configured to maintain a portion of the shaft 116 of the clot engagement element 102 in a non-contact relationship with the vessel wall 1004, and the clot engagement element 102 is clotted at the clot site. It can be configured to maintain the desired position relative to 1000. Thus, the control shaft 114 can act as a stabilizer for the clot engagement element 102 when the clot engagement element 102 is in the clot capture element 104. For example, the diameter of the control shaft 114 is large enough to allow longitudinal and rotational movement of the shaft 116, but the shaft 116, and thereby the clot engagement element 102, substantially from a predetermined position relative to the clot 1000. It can be made sufficiently small so as not to be biased. Thus, in an embodiment, the second shaft (shaft 116) can be rotatable and / or movable within the first shaft (control shaft 114). Thus, one function of the control shaft 114 is to center the shaft 116 within the vessel, so that when the engagement element 102 is rotated, the rotation occurs substantially in the longitudinal direction of the vessel. In an embodiment consistent with the present disclosure, the clot engagement element 102 can similarly be maintained in a generally axial direction of the vessel, for example, by maintaining the shaft 116 in a centralized position within the vessel, Thereby, the risk of damaging the blood vessel when the clot engagement element 102 rotates may be reduced.

  In the absence of or in addition to the control shaft 114, centering the engaging element within the vessel is illustrated by tapering the capture element 104 or centering the shaft 116 within the vessel. This can be done by using no spacer. In this regard, another embodiment of the present disclosure is a shaft, a clot engagement element at the end of the shaft, and at least partially a clot engagement element configured to be deployed in a blood vessel with the shaft. And a stabilizer that is configured to surround the shaft and maintain a portion of the shaft in a non-contact relationship with the vessel wall.

  In FIG. 2, for example, the shaft 116 is maintained in a non-contact relationship with the vessel wall by the control shaft 114 being interconnected centrally to the capture element 104. Thus, when the shaft 116 enters the lumen defined by the capture element 104, it is biased in a direction toward the center of the blood vessel. This helps maintain the engagement element to rotate in the longitudinal direction of the blood vessel when rotated, rather than proceeding substantially longitudinally. This is just one example of a stabilizer structure. Any structure that holds the shaft of the engagement element away from the vessel wall is contemplated for inclusion in this embodiment.

  The control shaft 114 can also be configured to transition the clot capture element 104 from an expanded configuration to an at least partially contracted configuration. For example, movement of the control shaft 114 in the direction indicated by arrow 115 in FIG. 2 will apply a force to the proximal end 104 a of the clot engagement element 104. The force applied to the proximal end 104a of the clot capture element 104 should also be in the direction indicated by the arrow 115 so that the clot capture element 104 can contract.

  During retraction, the clot capture element 104 can contract and when the clot 1000 and / or the clot engagement element 102 is within the central lumen 110 of the clot capture element, the clot 1000 and / or the clot engagement element 102 On the other hand, forces 1016 and 1018 (FIG. 8) are applied. Forces 1016, 1018 can maintain the clot 1000 within the central lumen 110 of the clot capture element 104 during removal of the clot 1000 from the blood vessel 1002 and reduce the tendency of the clot 1000 to break into multiple portions. Can do. The clot can then be retrieved from the blood vessel with the clot simply held within the capture and engagement elements, as shown in FIGS. 7A and 7B. Alternatively, for a clot that is small enough to fit within the sheath 118, the clot can be drawn into the sheath 118 prior to removal from the vessel, as shown in FIGS. 7C and 7D. In this manner, the sheath 118 can also apply additional holding force to the clot.

  According to at least some embodiments, a sheath can be provided that surrounds and compresses the capture and engagement elements. The sheath can be removable, thereby allowing the capture element to expand within the vessel in which the sheath is deployed and the engagement element to be expanded within the capture element. The sheath can hold one or more of the clot engagement element and the clot capture element, but any structure that can flex sufficiently to deploy one or more of these elements within the blood vessel. It can be.

  An exemplary sheath 118 consistent with at least some exemplary embodiments of the present disclosure is shown in FIG. Clot engagement element 102 and clot capture element 104 can be delivered to a clot site in sheath 118. The sheath 118 may be a hollow tubular structure having a central lumen configured to surround the clot engagement element 102 and the clot capture element 104 (FIG. 1A). The sheath 118 can be further configured to protect the clot engagement element 102 and the clot capture element 104 as they follow the delivery path to the clot site. Thus, the sheath 118 can be made from any suitable biocompatible material, and when the sheath 118 is delivered to and removed from the clot site, the clot engagement element 102 and the clot capture element 104 are It can have any suitable shape and / or configuration as long as it can be configured to navigate the patient's vasculature while maintaining the respective contracted configuration. Further, when the clot engagement element 102 and clot capture element 104 are removed from the clot site, the sheath can be configured to maintain the clot within its central lumen as well (FIG. 7D).

  Further, the sheath 118 can be configured to allow controlled expansion of the clot capture element 104 and the clot engagement element 102. For example, as previously discussed, the clot capture element 104 and the clot engagement element 102 can be configured to expand upon removal of the sheath 118. The sheath 118 can be retracted away from the distal end 104b of the clot capture element 104. The sheath 118 can be removed at a rate that can control the rate of expansion of the clot capture element 104 and clot engagement. In addition, the sheath 118 can be retracted a distance that can control the amount of clot capture element 104 and clot engagement element 102 that can be exposed and expanded (FIG. 1B). Alternatively, the sheath 118 can be substantially stationary, and the clot capture element 104 and the clot engagement element 102 can be advanced to expand these elements.

  According to another embodiment of the present disclosure, a tubular clot capture element having a first inner diameter and a clot engagement element having a second outer diameter can be provided, the first diameter and the second Is selected so that the clot engagement element can rotate within the tubular clot capture element.

  By way of example only, as shown in FIG. 2 and other figures, the inner diameter of the clot capture element 104 is dimensioned so that the clot engagement element 102 can be sufficiently rotated therein. Depending on the final commercial design, this can provide the operator with the freedom to surround the clot with the engagement element 102 at the same time that the clot is drawn into the capture element 104. Alternatively, it can provide the operator with the ability to turn the clot after it has entered the capture element 104. Thus, the elements 102, 104 can be dimensioned such that the outer surface area of the clot engagement element 102 can contact the inner surface area of the clot capture element 104.

  During operation of the clot removal apparatus 100, the apparatus operator will find that this is useful to prevent the clot engagement element 102 from moving relative to the clot capture element 104. This may be desirable, for example, during delivery of the clot removal device 100 to the clot site and / or during removal of the clot 1000 from the patient. Accordingly, FIG. 5 shows a locking mechanism 150 that can be used in the clot removal device 100 to selectively lock the shaft 116 of the clot engagement element 102 in a fixed position relative to the control shaft 114 of the clot capture element 104. ing. When the fixing mechanism 150 is rotated in one direction, the fixing can be performed, and when the fixing mechanism 150 is rotated in the opposite direction, the releasing can be performed. The locking mechanism can be any suitable device that selectively blocks relative movement between the clot engagement element and the clot capture element. Examples of securing mechanisms can include, but are not limited to, snap securing, rotational securing, and interference fit. For example, in one embodiment, the securing mechanism can be a torquer 150. Similar or different locking mechanisms can be used to control the relative movement between the sheath 118 and the capture element 104.

  The clot removal device 100 can also include components that allow an operator to know its position as the clot removal device 100 advances to the clot site. Location components can include, but are not limited to, radiopaque markers, sensors, and / or imaging devices. In one example, for example, the distal end 104b of the clot capture element 104 can include a radiopaque marker (not shown).

  With reference now to FIGS. 6A-6B, 7A-7D, and 8, a procedure for removing clots from a blood vessel is illustrated using the clot removal apparatus 100 shown in FIG. 1A. The clot removal device 100 can be delivered to a clot site within the blood vessel 1002. Delivery of the clot removal device 100 includes transferring a sheath 118 that can substantially enclose the clot engagement element 102 and the clot capture element 104 to a position close to the clot 1000 within the patient's vasculature. Can do. The operator of the device can insert the clot removal device 100 via the guide wire 120 to ensure that the clot removal device 100 follows the correct path to the clot site. During delivery within the sheath 118, the clot engagement element 102 can be substantially surrounded by the clot capture element 104, as shown in FIG. 1A. Alternatively, the clot engagement element 102 can be located outside the clot capture element 104 and can be retracted into the clot capture element 102 after gripping the clot 1000 at a later point in the procedure.

  As previously discussed, the operator of the device may monitor the position of the clot removal device 100 with a sensor, radiopaque marker, and / or imaging device as the clot removal device 100 approaches the clot site. it can. After the clot removal device 100 reaches the clot site, the operator of the device can remove the guide wire 120 from the clot removal device 100. The operator of the device can retract the sheath 118 sufficiently (or advance the engagement element) so that the engagement element 102 can rotate. Alternatively, the sheath 118 can be removed entirely. Upon separation of the sheath 118 from the clot engagement element 102, the clot engagement element 102 then expands radially and becomes movable within the clot capture element 104 (eg, longitudinal and rotational movement, etc.). sell. Both the clot engagement element 102 and the clot capture element 104 can self-expand spring-like. The clot capture element 104 can expand to approximately the inner diameter dimension of the blood vessel 1002. As previously discussed, the expansion of the clot capture element 104 can initiate the separation of the clot 1000 from the vessel wall 1004.

  The operator of the device moves the shaft 116 of the clot engagement element 102 in the direction of arrow 1010 toward the clot 1000 and rotates the shaft 116 in the direction of arrow 1012, thereby causing the clot engagement element 102 to move. It can be engaged with the clot 1000. Longitudinal movement of shaft 116 can cause clot engagement element 102 to move longitudinally in the direction of arrow 1010 ', and rotational movement of shaft 116 can cause clot engagement element 102 to rotate in the direction of arrow 1012'. Can be moved. The clot engagement element 102 can move along the longitudinal axis 1006 of the blood vessel toward the clot 1000. When the most distal end of the clot engagement element 102 reaches the clot 1000, the simultaneous longitudinal rotational movement of the shaft 116 allows the clot engagement element 102 to surround the clot 1000. If the winding 108 of the clot capture element 102 has a substantially constant pitch and a substantially constant radius, when the capture element 102 is wound, the winding will follow a single path and the clot To minimize the risk of clots breaking and separating. As the clot engagement element 102 surrounds the clot 1000, the clot engagement element 102 can be between the clot 1000 and the clot capture element. In some use cases, rotation of the clot engagement element 102 will result in an Archimedes screw effect that may further draw the clot into the engagement element 102 without having to fully advance the engagement element. it can. The degree of the Archimedes effect and whether it occurs can vary depending on the specific nature of the clot and its degree of binding to the vessel wall 1004.

  Surrounding the clot 1000 with the clot engagement element 102 can cause further expansion of the clot engagement element 102. As previously discussed, the radial expansion of the clot engagement element 102 allows the outer surface of the clot engagement element 102 to exert a force on the wall 1004 of the vessel 1002, causing the clot 1000 to move away from the vessel wall 1004. It can help further to separate. The separation can help reduce the force required to remove the clot 1000 from the blood vessel 1002. The separation can also help reduce the tendency of the clot 1000 to break into multiple parts while removing the clot from the blood vessel 1002.

  An operator of the device can use the clot engagement device to surround the clot 1000 so that both the clot engagement element 102 and the clot 1000 can be retracted into the clot capture element 104. Thus, the operator of the device can move the shaft 116 into an arrow so that the clot 1000 surrounded by the clot engagement element 102 can be pulled through the opening 112 of the clot capture element 104 into its central lumen 110. It can be moved in the direction of 1014.

  When the device operator pulls the clot 1000 and the clot engagement element 102 into the central lumen 110 of the clot capture element 104 in the direction of arrow 1014, the device operator also controls the clot capture element 104. The shaft 114 can be pulled in the direction of arrow 115. This pull can result in the clot capture element 104 applying a radial contraction force 1016 and a longitudinal shear force 1018 to the clot 1000 and the clot engagement element 102. These applied forces can help the operator of the device maintain the clot 1000 within the clot capture element 104 and remove it from the blood vessel 1002 without breaking it into multiple portions. If the clot breaks, the capture element 104 can loosen in the bloodstream and provide protection against debris.

  As shown in FIG. 7D, pulling the clot capture element 104 and the clot 1000 surrounded by the clot engagement element 102 simultaneously pulls the aforementioned components back into the sheath 118 in the direction of arrow 1020. Can result. Pulling the clot engagement element 102 and clot capture element 104 back into the sheath 118 may cause the clot engagement element 102 and clot capture element 104 to move from an expanded configuration (FIG. 7C) to a contracted configuration (FIG. 7D). Can result in a transition. The operator of the device can then remove the clot removal device 100 from the patient's vasculature along the longitudinal axis 1006 of the blood vessel 1002.

  Alternatively, the clot can be removed from the vasculature without drawing the capture and engagement elements back into the sheath. Alternatively, when the clot is confined within the capture element, the radial force applied during retraction may be sufficient to compress the clot into the capture element, thus substantially expanding the structure. It can be retreated in the form.

  The operator of the device can change the method of removing the clot 1000 from the blood vessel 1002 as needed. For example, prior to placing the clot engagement element 102 around the clot 1000, the operator of the device inserts an instrument that may be necessary to clean the clot site through the central lumen of the clot capture element 104. Can do. Further, removing the clot 1000 may add an appropriate tool for gripping and / or maintaining the clot 1000 within the clot capture element 104. For example, a device operator can use a suction device at the proximal end of the clot removal device 100. The suction device can further assist in retracting the clot 1000 into the clot capture element 104 and retaining the clot 104 within the clot capture element 104 when the clot 1000 is withdrawn out of the patient's vasculature.

  According to another embodiment of the present disclosure, a method for removing a clot from a blood vessel is the step of deploying a tubular clot capture element into the blood vessel, wherein the clot capture element receives and guides the clot engagement element. A step of enclosing the clot with a clot capture element, and retracting the clot capture element in a longitudinal direction of the blood vessel, wherein the clot capture element contracts radially and is radially inward of the clot. Applying a compressive force. This embodiment of the present disclosure can be implemented using any of the clot capture elements described above including the clot capture element 104.

  According to yet another embodiment of the present disclosure, a method for removing a clot from a blood vessel includes delivering a tubular clot capture element having a first diameter to a clot site and a clot having a second outer diameter. Delivering the combined element to the clot site, wherein the first diameter and the second diameter are selected such that the clot engagement element rotates within the tubular clot capture element. As previously described in connection with FIG. 2, such a method can be used, for example, when the clot capture element 104 is delivered to the clot site and the clot engagement element 102 is delivered to the clot site, and the two elements Such a method can be achieved if the diameter of the engagement allows the engagement element to rotate within the capture element.

  Although the capture element and the engagement element can be deployed together, such as within the same sheath, the present disclosure need not be so in its broadest sense. For example, the engagement element can be delivered first and the capture element can be delivered thereafter. Further, when rotated, the engagement element can be dimensioned to contact the inner wall of the capture element, or the engagement element can be dimensioned to avoid contact.

  According to a further embodiment of the present disclosure, a method for removing a clot from a blood vessel includes deploying a clot engagement element located at an end of the shaft into the blood vessel, and removing a portion of the shaft from the vessel wall. To at least partially surround the shaft with a stabilizer to maintain a contact relationship. This method can be performed with or without a clot capture element, such as structure 104, and can be performed regardless of any particular stabilizing structure. As previously mentioned, depending on design choices, some embodiments of the present disclosure may benefit by rotating the engagement element 102 once the engagement element is centered within the blood vessel. it can. In this way, the pressure on the vessel wall can be minimized while maximizing the movement of the engagement element 102 in the longitudinal direction of the vessel to surround the clot. By stabilizing the shaft (eg, shaft 116) that rotates the engagement element (eg, 102) toward the center of the blood vessel, longitudinal movement can be maximized. Thus, stabilization can be accomplished by surrounding shaft 116 with any structure that generally maintains near the center of the blood vessel near the intersection of shaft 116 and winding 108.

  Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples are considered to be exemplary only, with the true scope being intended to be indicated by the appended claims.

Claims (80)

An expandable clot engagement element;
An expandable clot capture element;
A sheath that surrounds and compresses the capture element and the engagement element, the sheath being removable, thereby allowing the capture element to expand within the vessel in which the sheath is deployed, and the capture A clot removal device comprising a sheath that allows the engagement element to expand within the element.   The apparatus of claim 1, wherein the capture element surrounds the engagement element.   The apparatus of claim 1, wherein the engagement element is a coil.   The apparatus of claim 1, wherein the capture element comprises a mesh-like structure.   The apparatus of claim 1, wherein upon removal of the sheath, the engagement element is dimensioned to be movable within the capture element.   The apparatus of claim 1, wherein upon removal of the sheath, the engagement element is dimensioned to be rotatable within the capture element.   The apparatus of claim 1, wherein the capture element has a length that is greater than a length of the engagement element.   The apparatus of claim 1, further comprising a locking mechanism for locking the clot engagement element within the clot capture element.   The capture element is sized to engage the vessel wall when deployed, and the engagement element is dimensioned to be movable within the capture element when deployed. The apparatus of claim 1.   The apparatus of claim 1, wherein the capture element and the engagement element are configured such that when used, the engagement element is between the capture element and the clot. A method of removing clots from blood vessels,
Deploying a clot removal device at a clot site in a blood vessel, wherein the clot removal device surrounds and compresses an expandable clot engagement element, an expandable clot capture element, and the capture element and the engagement element Including a sheath to perform, and
Removing the sheath from the capture element and the engagement element such that the capture element expands within the blood vessel and the engagement element expands within the capture element.   The method of claim 11, wherein the capture element surrounds the engagement element.   The method of claim 11, wherein the engagement element is a coil.   The method of claim 11, wherein the capture element comprises a mesh-like structure.   The method of claim 11, wherein upon removal of the sheath, the engagement element moves within the capture element.   The method of claim 11, wherein upon removal of the sheath, the engagement element rotates within the capture element.   The method of claim 11, wherein the capture element has a length that is greater than a length of the engagement element.   The method of claim 11, further comprising using a locking mechanism to lock the clot engagement element within the clot capture element.   The method of claim 11, wherein the capture element engages the vessel wall when deployed and the engagement element moves within the capture element when deployed.   The method of claim 11, wherein when the capture element and the engagement element are used, the engagement element is between the capture element and the clot. A clot removal device comprising a tubular clot capture element comprising:
The clot capture element is configured to deploy within a blood vessel to surround the clot, the clot capture element having an opening configured to receive and guide a clot engagement element; The element is configured to contract radially when retracted, so that when the clot capture element surrounds the clot and retracts in the longitudinal direction of the blood vessel, the clot capture element is relative to the clot. A clot remover configured to apply a radially inner compressive force.   The apparatus of claim 21, wherein the clot capture element is in the form of a mesh-like structure.   23. The apparatus of claim 22, wherein the mesh-like structure is a net.   24. The apparatus of claim 23, wherein the net is braided.   24. The apparatus of claim 23, wherein the net includes a plurality of intersecting braids, and each of the plurality of intersecting braids is movable relative to each other.   24. The apparatus of claim 23, wherein the net includes a plurality of wires, a proximal end, and a distal end, and wherein the proximal end and the distal end are free of open ends of wires.   The apparatus of claim 21, wherein the clot engagement element includes a coil and a shaft connected to the coil.   The apparatus of claim 21, further comprising a control shaft, wherein the clot capture element includes a proximal end and a distal end, and wherein the control shaft extends from the proximal end.   29. The control shaft and the clot capture element are configured such that when the control shaft is retracted in the longitudinal direction of the blood vessel, the clot capture element is retracted in the longitudinal direction of the blood vessel. Equipment.   The apparatus of claim 21, wherein the clot capture element is configured to apply a longitudinal shear force to the clot when retracted in the longitudinal direction of the blood vessel. A method of removing clots from blood vessels,
Deploying a tubular clot capture element into a blood vessel, the clot capture element having an opening for receiving and guiding the clot engagement element;
Surrounding the clot with the clot capture element;
Retracting the clot capture element in the longitudinal direction of the blood vessel so that the clot capture element contracts radially and applies a radially inward compressive force to the clot.   32. The method of claim 31, wherein the clot capture element is in the form of a mesh-like structure.   The method of claim 32, wherein the mesh-like structure is in the form of a net.   34. The method of claim 33, wherein the net is braided.   34. The method of claim 33, wherein the net includes a plurality of intersecting braids and each of the plurality of intersecting braids is movable relative to each other.   34. The method of claim 33, wherein the net includes a plurality of wires, a proximal end, and a distal end, and wherein the proximal end and the distal end do not have an open end of the wire.   32. The method of claim 31, wherein the clot engagement element includes a coil and a shaft connected to the coil.   32. The method of claim 31, wherein the clot capture element includes a proximal end and a distal end, and a control shaft extends from the proximal end.   40. The method of claim 38, wherein the clot capture element is retracted by a control shaft extending from the clot capture element.   32. The method of claim 31, wherein the step of retracting the clot capture element in the longitudinal direction of the blood vessel comprises applying a longitudinal shear force to the clot. A tubular clot capture element having a first inner diameter;
A clot engagement element having a second outer diameter;
The clot removal device, wherein the first diameter and the second diameter are selected to allow the clot engagement element to rotate within the tubular clot capture element.   42. The apparatus of claim 41, wherein the tubular clot capture element comprises a mesh-like structure.   42. The apparatus of claim 41, wherein the clot engagement element comprises a coil.   The tubular clot capture element includes a mesh structure, the clot engagement element includes a coil, the coil is configured to rotate about the outside of the clot, and the mesh structure includes the coil 42. The apparatus of claim 41, wherein the apparatus is configured to include the clot.   42. The apparatus of claim 41, wherein the first diameter and the second diameter are selected such that an outer surface area of the clot engagement element contacts an inner surface area of the clot capture element.   42. The apparatus of claim 41, further comprising a locking mechanism that locks the clot engagement element within the clot capture element.   42. The apparatus of claim 41, wherein the first diameter and the second diameter are selected such that the clot engagement element can be moved longitudinally within the clot capture element.   42. The apparatus of claim 41, wherein the first diameter and the second diameter are selected such that the clot engagement element can be expanded within the clot capture element.   The apparatus further comprises a first shaft extending from the proximal end of the clot capture element and a second shaft extending from the proximal end of the clot engaging element such that the second shaft rotates within the first shaft. 42. The apparatus of claim 41, configured as follows. A method of removing clots from blood vessels,
Delivering a tubular clot capture element having a first diameter to the clot site;
Delivering a clot engagement element having a second outer diameter to the clot site;
The method wherein the first diameter and the second diameter are selected such that the clot engagement element rotates within the tubular clot capture element.   51. The method of claim 50, wherein the tubular clot capture element comprises a mesh-like structure.   51. The method of claim 50, wherein the clot engagement element comprises a coil.   The tubular clot capture element includes a mesh-like structure, and the clot engagement element includes a coil, and the method rotates a coil that rotates about the outside of the clot, and at least one of the coil and the clot. 51. The method of claim 50, further comprising including a portion in the mesh-like structure.   51. The method of claim 50, wherein the first diameter and the second diameter are selected such that an outer surface area of the clot engagement element contacts an inner surface area of the clot capture element.   51. The method of claim 50, wherein a locking mechanism locks the clot engagement element within the clot capture element.   51. The method of claim 50, further comprising moving the clot engagement element longitudinally within the clot capture element.   A first shaft extends from the proximal end of the clot capture element, and a second shaft extends from the proximal end of the clot engaging element, and the method attaches the second shaft to the first shaft. 51. The method of claim 50, further comprising rotating within. A shaft,
A clot engagement element at an end of the shaft, the clot engagement element and the shaft configured to be deployed in a blood vessel;
A clot removal device comprising: a stabilizer configured to at least partially surround the shaft and to maintain a portion of the shaft in a non-contact relationship with the vessel wall.   59. The apparatus of claim 58, wherein the clot engagement element is a coil.   59. The apparatus of claim 58, wherein the coil includes a plurality of windings having a substantially constant pitch.   59. The apparatus of claim 58, wherein the coil includes a plurality of windings having a substantially constant radius.   59. The apparatus of claim 58, wherein the stabilizer is configured to maintain the coil generally axially within the blood vessel.   58. The apparatus of claim 57, further comprising a clot capture element, and wherein the stabilizer is connected to the clot capture element.   64. The apparatus of claim 63, wherein the clot capture element is a mesh tube and the stabilizer includes an opening at an end of the mesh tube.   64. The apparatus of claim 63, wherein the stabilizer includes a portion of a control shaft extending from a proximal end of the clot capture element. A shaft,
A clot engagement element at the end of the shaft, including a rotatable coil, wherein the coil extends from the shaft and is configured to be deployed within the blood vessel. And
A clot removal device comprising a stabilizer including an opening through which the shaft passes, the stabilizer being configured to maintain the shaft generally in the center of the blood vessel during rotation of the coil.   68. The apparatus of claim 66, wherein the stabilizer includes a tube with a tapered end, and the opening is located at the tapered end.   68. The apparatus of claim 67, wherein the tube is made from a mesh-like structure.   69. The apparatus of claim 68, wherein the mesh-like structure is configured to contract radially when the tube is retracted in the longitudinal direction of the blood vessel. A method of removing clots from blood vessels,
Deploying a clot engagement element located at the end of the shaft into the blood vessel;
Deploying a stabilizer within the blood vessel to at least partially surround the shaft and maintain a portion of the shaft in a non-contact relationship with the vessel wall.   And further comprising positioning a stabilizer at a location adjacent to the clot engagement element, and wherein the stabilizer is configured to substantially center the clot engagement element within the blood vessel. 71. The method of claim 70.   72. The method of claim 71, further comprising rotating the clot engagement element about the clot while the clot engagement element is substantially centered by the stabilizer.   72. The method of claim 70, wherein the clot engagement element is a coil.   74. The method of claim 73, wherein the coil includes a plurality of windings having a substantially constant pitch.   74. The method of claim 73, wherein the coil includes a plurality of windings having a substantially constant radius.   74. The method of claim 73, wherein the stabilizer maintains the coil in a generally axial direction of the blood vessel.   71. The method of claim 70, further comprising deploying a clot capture element within the blood vessel, and wherein the stabilizer is connected to the clot capture element.   71. The method of claim 70, wherein the clot capture element is a mesh tube and the stabilizer includes an opening at an end of the mesh tube.   79. The method of claim 78, wherein the stabilizer includes a portion of a control shaft that extends from a proximal end of the clot capture element.   51. The method of claim 50, further comprising expanding the clot engagement element within the clot capture element.

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