Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
  • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
  • A61B17/2202—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
  • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
  • A61B2017/2217—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions single wire changing shape to a gripping configuration

Definitions

• embolectomy device as defined above, wherein the cross section of at least one of said loops and/or said mesh-like net varies. It is another object of the present invention to provide a method for removing a clot from blood vessel. The method comprising steps selected inter alia from: i. obtaining an embolectomy device comprising: a. an endless wire coupled to a spring-like helical member having a plurality of loops; said loops are positioned at an angle A relatively to the main longitudinal axis of said blood vessel; b. a tubular mesh-like net; ii. integrating said spring-like helical member with said tubular mesh-like net; iii.
• Figure Ia illustrates an out-of-scale manner a schematic view (cross section) of the device according to a preferred embodiment of the present invention.
• Figures 2a to 2e illustrate the entire device (i.e., the coil and the tubular mesh-like net) as described by the present invention.
• Figure 3 a illustrates a second embodiment of the device as described by the present invention in which an inner corkscrew-like effecter is utilized.
• FIGS 4a-4c illustrating the rotatable spring-like helical effecter integrated with the tubular mesh-like net.
• Figure 6 is a view of an intravascular catheter according to the present invention and an associated guide wire.
• FIGS 7 A, 7B, 7C illustrate another embodiment of the catheter provided by the present invention.
• Figures HA, HB, and HC illustrate another embodiment of the catheter provided by the present invention.
• Figure 12 illustrates another embodiment of the catheter provided by the present invention.
• FIG. 13 illustrates another embodiment of the present invention.
• Figure 15 illustrates a schematic depiction of a method of using the catheter according to one embodiment of the present invention.
• Figures 16A and 16B illustrate the embolectomy device utilizing the rotatable spring-like helical effecter.
• Figure 16C illustrates a variation of a rotating helical assembly.
• Figures 17A and 17B illustrate another embodiment of the embolectomy device utilizing the rotatable spring-like helical effecter.
• Figure 17C illustrates another variation of the rotatable spring-like helical effecter.
• Figures 18A-18C illustrate the distal tip of the catheter with a rotating element configured to remove a clot as a whole from an artery.
• Figure 19 shows a procedure for removing a clot using the variation shown in Figures 18A- 18C.
• Figures 2OA, 20B(I), and 20B(2) show further variations of the device in which the catheter has an expandable distal-most portion.
• Figure 21 shows a partial cutaway side view of one variation of the expanded catheter tip.
• Figures 23 A and 23B show a partial cutaway side view of the expanded catheter tip.
• Figures 24 and 25 show perspective views of other variations of the expanded catheter tip.
• crossing refers hereinafter to act of intersecting clot and penetrating its interior.
• the term “about” refers hereinafter to a range of 25% below or above the referred value.
• non-fragmented manner refers hereinafter to extraction of clots intact, i.e., the clot is removed as a whole without the danger of fragmenting within the vasculature.
• the device of the present invention is intended to be used as a flow restoration device. Even in those instances where the clot is not or cannot be completely removed, the device of the present invention is believed to be useful in removing the clot in a non-fragmented manner (i.e., as a whole) and thereby permitting restoration of partial blood flow.
• the device of the present invention is sufficiently flexible to be placed in distal tortuous anatomy and hence is useful in treating blocking clot found there.
• the present invention provides an embolectomy device for extracting a clot in an intact manner from a blood vessel without fragmenting it.
• the device comprises an endless wire having a distal end.
• the distal end comprising a spring-like helical member having a plurality of loops.
• the loops are positioned at an angle A relatively to the main longitudinal axis of said blood vessel, and radially encircle [without crossing] at least a portion of the outer circumference of the clot. It is acknowledge that angle A ranges from about 0 degrees to about 180 degrees, namely 90 to 180 degrees.
• the embolectomy device By configuring the embolectomy device to contain both the mesh-like net and the spring-like helical member - coil, the entire clot mass is confined within the mesh-like net during reciprocal movement (i.e., extraction) of the clot, so as to provide (i) extraction of the entire mass of the clot from the blood vessel (in a non- fragmented manner); and, (H) prevention of re-entry of clot mass or fragments thereof into the blood vessel.
• Treatments for embolic occlusions include catheterization of the patient and introduction of tissue plasminogen activator (t-PA), urokinase, or streptokinase to the site of the occlusion. Additionally the embolic occlusion may be penetrated— often with a microcatheter— and the t- PA or urokinase or streptokinase introduced distally of the occlusion.
• t-PA tissue plasminogen activator
• urokinase urokinase
• streptokinase streptokinase
• FIG. Ib-Id presenting in an out-of-scale manner a schematic view (cross section) of the rotatable spring-like helical member 2101 used in the minimally invasive embolectomy device according to one embodiment of the invention (the tubular mesh-like net will be described in figures 2).
• the device comprises a rotatable spring-like helical member, adapted to grasp and separate the clot from the artery wall and extracts it from outside of the artery.
• the helical member comprises a plurality of loops which are positioned at an angle A relatively to the main longitudinal axis of said blood vessel. It is acknowledged that angle A ranges from about 0 degrees to about 180 degrees, namely 90 to 180 degrees.
• Said grasping and separating is performed by spiral-like encircling (i.e., enveloping, without crossing) of at least a portion of the outer circumference of the clot by the plurality of loops.
• the encircling is performed without intersecting or crossing the clot; and by manipulating the clot reciprocally and/or rotationally with respect to the main longitudinal axis.
• Crumbling of the clot may occur when the clot is crossed (i.e., intersected), and fragments can be left within the blood vessel.
• the device additionally comprises a tubular mesh-like net (as illustrated in the following figures, namely figure 2) for both enveloping the helical member and enclosing the clot therein.
• the mesh-like net enables extraction of the entire clot mass during the extraction in a non fragmented manner, such that reentry of clot mass or fragments thereof into said blood vessel is prevented.
• the mesh-like net may have several features, e.g., mechanical, chemical, thermal, etc., allowing it to engage a clot or embolism.
• the mesh-like net may also be in communication with a vacuum source allowing enhanced grasp of the clot or embolism for removal or other treatment.
• the mesh-like net may be used with a guidewire to direct the catheter to the site of the clot or clot.
• the shaft of the mesh-like net is hollow so as to enable introduction of wires.
• the spring-like helical member may include one or more distally located, protrusions for assisting in the separation of the clot or embolism from the wall of the artery.
• the spring-like helical member and/or the mesh-like net may comprise means for applying vibration on the clot so as to facilitate its extraction.
• MCA middle cerebral artery
• the path from the site of origin of a traveling clot —often the heart— to the MCA is via the common carotid artery past the branch point forming the external and internal carotid arteries into the internal carotid artery (ICA).
• ICA internal carotid artery
• the MCA is generally considered to be the continuation and termination of the ICA past the siphon and pat the branching of a variety of other arteries, e.g., the ophthalmic artery, the anterior communicating artery, , and others.
• embolic occlusion is varied, varying, and complicated.
• Treatments for such embolic occlusions include catheterization of the patient and introduction of tissue plasminogen activator (t-PA), urokinase, or streptokinase to the site of the occlusion. Additionally the embolic occlusion may be penetrated or crossed.
• tissue plasminogen activator t-PA
• urokinase urokinase
• streptokinase streptokinase
• the device of the present invention is intended to be used in removing clots or at least recanalizing (at least partially) occluded vascular lumen.
• the device is designed to extract clot (1010) found in the human vasculature (1020), particularly in the distal, tortuous neurovasculature with a low or minimized pulling or extractive force outside the body of the patient.
• the device comprises an endless wire (116) having a distal end (2102).
• the distal end comprising a spring-like helical member (2101) for capturing the clot (1010).
• the helical member comprising a plurality of loops (2201) positioned at an angle A relatively to the main longitudinal axis (as illustrated in the figure as B) of the blood vessel (1020).
• angle A ranges from about 0 degrees to about 180 degrees, namely 90 to 180 degrees.
• the loops are configured to (i) spirally encircle (e.g., envelope) the clot without intersecting and crossing the clot; and, (ii) manipulate said clot reciprocally and/or rotationally with respect to the main longitudinal axis of the clot; such that its separation from the internal wall of the vessel is facilitated.
• the loops warp the outer circumference of the clot, and apply a preset and well directed force, to grasp the clot in a vector which is approximately parallel to its main longitudinal axis, namely a force applied from and towards the clot's distal and/or proximal poles.
• FIG. 1c illustrates the manipulation that can be exerted on the clot by the loops.
• the endless wire as described above, is characterized by a distal spool (spring-like) portion.
• clot 1010 reciprocated and/or circularly actuateed (1040 and 1030, respectively), until it is separated from vascular wall 1020.
• the device also comprises a tubular mesh-like net which is an essential member of the device.
• the mesh-like net will be described hereinafter.
• the clot is simultaneously encircled by the loops and entrapped by the mesh-like net, according to yet another embodiment, the clot is first entrapped by the mesh-like net and only then it is encircled by the loops.
• the device is useful to (i) free the clot from its surrounding vascular wall by applying reciprocal/rotational maneuvers; (ii) enforce the clot towards the mesh-like net's distal inlet in a safe manner, i.e., in a way the clot does not break to small pieces and does not escape, i.e., as a whole; and (iii), position the clot, as is, within the mesh-like net in a safe manner, i.e., in a way in which the clot does not disengage to small pieces and does not escape, as a whole, downstream away from the mesh-like net.
• the distal inlet of the mesh-like net (1101) is a constricting sphincter-like orifice.
• the diameter of orifice is regulated, e.g., by means of operating wires 1011 and 1012, by electrical charge (in case of Nitinol made sphincters) by electro-active polymers, by temperature (e.g., heat in case of Nitinol made sphincters) etc.
• FIG. 3a in which the device additionally comprising a corkscrew- like effecter 118, having a coil-like 2002 distal end, adapted to effectively anchor the clot from its inner portion, and an endless wire 2001 which terminates in a operating portion 2003 of the effecter, locate in the very proximal end, namely outside the body of the patient.
• a corkscrew- like effecter 118 having a coil-like 2002 distal end, adapted to effectively anchor the clot from its inner portion, and an endless wire 2001 which terminates in a operating portion 2003 of the effecter, locate in the very proximal end, namely outside the body of the patient.
• each of the above described loops can additionally comprise vibration means can be utilized to assist in removing the clot from the vascular wall.
• aspiration can be applied to assist in the separation and extraction of the clot from the vessel.
• the endless wire and/or the spring-like helical member and/or the mesh-like net are coated with lubricious polymeric material such as a hydrophilic polymer material, e.g., one containing polyvinylpyrrolidone.
• lubricious polymeric material such as a hydrophilic polymer material, e.g., one containing polyvinylpyrrolidone.
• the endless wire and/or the spring-like helical member and/or the mesh-like net may have multiple polymeric layers and include woven braids, flat ribbon coils, or wire coils between those layers to provide stiffness, kink resistance, etc.
• the endless wire and/or the spring-like helical member and/or the mesh-like net are characterized by a varied diameter so as to better fit the clot.
• the endless wire and/or the spring-like helical member and/or the mesh-like net are characterized by several different diameters along its length so as to better fit the clot
• the clot can be crossed via the corkscrew-like effecter 118.
• the device additionally comprising between two opposing, multi-element collection assemblies, i.e., distal clasp and proximal clasp.
• the two clasps combined with the spring-like helical member will extract the clot with a low or minimized pulling or extractive force in an intact manner (i.e., the entire clot is extracted from the body).
• Figure 5a illustrates the spring-like helical member (2101) and the plurality of loops (2201), which are positioned at an angle A relatively to the main longitudinal axis of the blood vessel 1020. It is acknowledged that angle A ranges from about 0 degrees to about 180 degrees.
• the combined device is adapted to (i) reversibly grasp a clot (1010) between two opposing, multi-element collection assemblies, i.e., distal clasp (1300) and proximal clasp (1400) and, confined within the plurality of loops. In doing so, the clot is separated from the vascular wall.
• the device is also adapted to (H) insert the clot (1010) within of mesh-like net (1100, see figure 5b) via it's the distal inlet (1 101); and then///#,when clot (1010) is secured within mesh-like net (1100), extracting enveloped clot form within the body.
• Figure 5b illustrates a clot (1010) in an occluded vascular lumen (1020).
• a mesh-like net-like graft (1100) is inserted within lumen (1020), e.g., in a percutaneous manner, such that its distal end is located adjacent the clot.
• Guidewire 1200 operated from its proximal portion (1201), is inserted through the mesh-like net (1100) and manipulated to cross the clot, e.g., by means of an effecter 1210 located in its very distal end.
• the effecter is selected, in a non- limiting manner, from a group consisting of a coil-like, screw-like or drill-like head, reciprocally and/or rotatably operated in one or by a sequence of maneuvers.
• a small-diameter bore (1013) is provided within clot (1010).
• guidewire (1200) crosses the clot without forming a noticeable bore.
• Figure 5d illustrates the distal clasp (1300) in its OPEN configuration.
• the diameter of the clasp in this illustration, is adapted to fit in size and shape the inner diameter of the blood vessel 1020.
• Figure 5e illustrates both distal clasp (1300) and proximal clasp (1400) in their OPEN configuration. Distal clasp and proximal clasp are manipulated by means of at least one operating wires 1310 and 1410, respectively.
• Figure 5f illustrates a possible mode of action of the device especially adapted to (i) reversibly grasp clot (1010) between the two opposing distal clasp (1300) and proximal clasp (1400) and confined within the loops of the spring-like helical member.
• One or both of the clasps are manipulated, e.g., either linearly (1041) or rotatably (1031) by means of operating wires in, e.g., (i) a single reciprocal stroke along the long longitudinal axis of the blood vessel, wherein clot is maneuvered in a reciprocate facilitated motion (1040); (H) a set of reciprocal motions, for example in-and-out opposite motions, a vibrating set of reciprocal motions, etc.; (Hi) a single rotating stroke around the long longitudinal axis of the blood vessel, wherein clot is maneuvered in a circle facilitated motion (1030); (iv) a set of rotational motions, for example circular opposite motions, a vibrating set of circular motions, etc.; and (v)any combination of the same. By those maneuvers, the clot is separated from the vascular wall 1020.
• Figure 5g illustrates the step wherein clot (1010) which was separated from the vascular wall is inserted within mesh-like net (1100) via its distal inlet (1101), by pulling distal clasp (1300) inside the mesh-like net.
• distal inlet of the mesh-like net (1101) is a constricting sphincter-like orifice.
• the diameter of orifice is regulated, e.g., by means of operating wires 1011 and 1012, by electrical charge (in case of Nitinol made sphincters) by electro-active polymers etc.
• the diameter of the orifice is reduced, e.g., from open configuration 1013 to semi close configuration 1014, or to a totally close configuration (not shown here).
• Figure 5j illustrates the last step, in which the enveloped clot (see conjugate 1500) is safely extracted form within the body outside the body.
• all operating wires are pulled (1050) and clasped clot 1500, now free from its native vascular wall 1020 is pulled via predetermined track 1021 outside of the patient's body.
• Figure 8 A shows a close-up, side-view of the distal end (140) of another variation of the catheter component (102).
• a radio-opaque marker band (132) is also shown.
• a set of pins (142) is extended from that distal end (see Figure 8B) to engage the clot, e.g., by penetrating the clot.
• the combination of the catheter, as any of the described above, utilizing the endless wire having a spring-like helical member which comprises a plurality of loops (see figure 1 OA, which illustrated the loops extending from the catheter body) is provided.
• the active clot's engaging feature is a reactive or adhesive region (172) that adheres to a targeted clot upon contact with that clot.
• Figures HB and HC show the combination of the catheter shown in Figure HA with an exterior slideable sleeve (174) that, in Figure HB, is extended to protect the reactive or adhesive region (172) as the catheter passes to the target clot.
• Figure HC shows the sleeve (174) after retraction to expose the reactive or adhesive region (172).
• the catheter (180) shown in Figure 12 includes a nosepiece (182) containing a heating element that either directly heats the clot upon contact with the clot or activates a grasping end on the catheter upon heating.
• Figure 13 illustrates a partial, cross-sectional, side-view of the distal tip (182) of the catheter component (180) shown in Figure 12.
• the heating element (184) in this variation is placed distally to provide maximum heat transfer to the clot. Electrical current is supplied through wire (186).
• Figures 14A and 14B illustrate a variation of the catheter component (180) found in Figure 12 having a heat-actuated region that shrinks upon that heating to grasp the clot.
• Figure 14A provides a partial cross-sectional view of the distal tip of the variation shown in Figure 12.
• the catheter body (186) comprises a distal tip (188) having a heat-shrinkable polymer, e.g., pre-oriented polyolefin, polyvinylchloride (PVC), fluoropolymers such as FEP, PTFE, polyvinylidene fluoride (e.g., KYNAR), neoprene, silicone elastomers, and fluorocarbon elastomers (e.g., VITON, FLUOREL).
• a heat-shrinkable polymer e.g., pre-oriented polyolefin, polyvinylchloride (PVC), fluoropolymers such as FEP, PTFE, polyvinylidene fluoride (e.g., KYNAR), neoprene, silicone elastomers, and fluorocarbon elastomers (e.g., VI
• step (a) the distal end of a microcatheter (204) has been placed in the vicinity of the target clot (200) using a guidewire (206).
• Figures 16A to 17C illustrate the use the embolectomy device, namely the endless wire with the spring-like helical member and the plurality of loops, in removing a clot.
• endless wire 116 may be used with one of the specially dedicated catheter described above or any other standard catheter.
• Figure 16Al provides a partial, cutaway, side-view of the loops of the spring-like helical member (300) (of the endless wire) having a rotating helix (302) within a catheter body (304).
• the depicted helix (302) is shown as a ribbon; it may be constructed by cutting an appropriately sized hypotube into a helix or by winding a ribbon into the noted helix (302).
• the width of the ribbon or thread may be constant or varying over the length of the helix.
• the helix (302) may have a constant pitch or a varying one.
• the helix (302) may be a single, double, or triple pitch.
• the helix extends from the distal end proximally for at least a portion of the distance to a drive assembly that rotates the helix (302).
• the helix (302) may have an extension (306) that, as the helix (302) is rotated, separates a target clot from an arterial wall and transports the clot into the mesh-like net as described above (not shown)and eventually through the catheter lumen (or).
• the core wire can be used as a screw penetrating internally into the clot (unlike the loops of the endless wire described above which merely encircles the clot).
• Figures 16Al and 16A2 illustrate an optional outer sheath (310) fitting loosely about catheter body (304) that allows the user to inject medicines or contrast agents at the clot site.
• the rotatable spring-like helical effecter may be operated with or without the core wire (308).
• a variation of this component involves affixing the rotatable spring-like helical effecter (302) to the core wire (308) at one or more sites and rotating the two together.
• the catheter body (304) lumen will be attached to a vacuum source, although this is not required.
• Figure 16B illustrates a side view of the extension (306) located on the spring-like helical member (of the endless wire)within a catheter body (304).
• Figure 16C illustrates another embodiment (305) of the endless wire and namely, the springlike helical member.
• the depicted rotating helix assembly (305) comprises a distal ribbon-form helix (307) and a hollow more-proximal drive shaft (309).
• the drive shaft (309) is shown to have a number of flexibility slots (311) allowing the shaft (309) to smoothly flex during rotation of the rotating helix assembly (305) and to flex with greater bend angles.
• the ribbon-form helix (307) is attached to the drive shaft (309) by an appropriate joining method, e.g., welding, soldering, gluing, etc.
• the length of the ribbon-form helix (307) may be reasonably short, e.g., less than about 2-3 inches. Longer helix components may bind during rotation.
• Figures 17A and 17B illustrate another embodiment (310) of the endless wire substantially similar to the variation shown in Figures 16A and 16B, with the exception of the shape of the rotating helix (312) which is a wire and that the wire- form rotating helix (312) is wrapped around a central core wire (314).
• the wire-form rotating helix (312) may have a diameter such as seen with the ribbon-form rotating helix (302) shown in Figure 16 A. Additionally the wire-form rotating helix (312) may be utilized without the central core wire (314).
• the wire comprising the wire-form rotating helix (312) may have a circular cross-section or other cross sections suitable to the designer, e.g., oval or fin-like projections, to enhance carriage of the embolic fragments through the catheter body (306).
• the cross-section of that wire may be constant or vary as desired by the designer.
• Figure 17C is a side view of another embodiment (315) of the endless wire.
• the endless wire (315) comprises a distal wire-form helix (317) and a hollow more-proximal drive shaft (319).
• the drive shaft (319) is also shown to have a number of flexibility slots (321).
• the wire-form helix (317) is attached to the drive shaft (319) by an appropriate joining method.
• Figures 18A-18C show a variation of the rotating element in a catheter tip designed to extract a clot into the catheter in a substantially complete and whole form rather than macerating it.
• Figure 18A provides an end view of the catheter (420) enclosing a rotating helical element (422) having an extended portion (424). Because the extended portion (424) has substantially no radial component, it may be used to separate a target clot from the artery wall, particularly when used with vacuum in the catheter lumen and with a guidewire.
• Figure 18B shows a side-view of the catheter (420) and the tip or extension (424) of the rotating helical element.
• the distal most end of the extended portion (424) is blunt for the reasons of preventing damage to the intima of the artery and preventing penetration of the clot.
• the Figure also shows a radio-opaque band (426) allowing radiographic visualization of the position of that tip.
• Figure 19 illustrates a method for using the endless wire, as described above for extracting a clot.
• step (a) a clot (452) in an artery (450) is shown.
• a guidewire (454) has been introduced past the clot (452).
• the catheter (456) diameter has been chosen to approach the inner diameter of the artery (450).
• step (b) the distal end of the catheter (456) has contacted the clot (452).
• a vacuum may be applied to the catheter's (456) lumen to firmly attach the catheter (456) to the clot (452).
• Rotation of the helix (458) via the hollow drive shaft (460) begins. Such rotation encircles the clot from the out surface. It should be emphasized that the loops of the endless wire does not cross the clot. Such an action may lead to crumbling of the clot.
• step (c) the rotating helix (458) has disengaged the clot (452) from the arterial wall (450). Now the clot is being confined via the tubular mesh-like net (not shown in the figure). Finally clot (452) is being pulled into the catheter (456).
• the clot can be encircled first by the net and then by the loops of the helical member (i.e., the helix); the clot can be first encircled by the the loops of the helical member (i.e., the helix) and then by the net; or simultaneously by the net and the loops.
• Figure 2OA illustrates yet another embodiment of device (460) having both an expandable, rotatable, helical member (462) and a micro-catheter (464) having a distal section that is expandable upon reaching a target clot.
• This embodiment also includes a central core member, a guidewire (468), and an outer covering or sheath (470) allowing control of the expansion of the catheter (464) tip.
• the guidewire (468) may be withdrawn before beginning the grasping of the clot.
• Figures 20B(I) and 20B(2) show two variations of the device (460) after expansion of the catheter (464) and the rotatable member (462).
• Figure 20B(I) shows the variation in which the loops(462) of the spring-like helical member of the endless wire extend distally from the micro-catheter (464) when extracting the target clot.
• the rotating member (462) is turned using the driving member (472) and at least partially envelopes the target clot and subsequently or simultaneously enclosed by the mesh-like net and eventually drawn into the catheter (464) for extraction from the blood vessel.
• Figure 20B(2) shows a variation in which the loops(462) of the spring-like helical member is maintained substantially within the catheter (464) tip.
• the clot is drawn into the catheter (464) tip rather than being pulled in later.
• the rotating member (462) is turned, it encircles the clot and then the clot is being enclosed by the net (as mention above this operation mode is optionally).
• FIG. 21 illustrates another embodiment of an expandable catheter tip (480) having pre- shaped, longitudinal ribs (482) that, upon withdrawal of the control sheath (470 in Figures 16A, 16B(I), and 16B(2)) form an expanded region in the catheter tip (480).
• the supporting ribs (482) may be springy, e.g., comprising an elastic material such as nitinol or the like, they may also be malleable and formed in-situ perhaps by the expandable rotatable member.
• Figure 22 provides a perspective, partial cutaway view of another variation of the device (490) shown in Figures 2OA and 20B(2).
• the variation (490) includes the expanded micro- catheter (492), expanded rotatable member (494), guidewire (496), and control sheath (498).
• the driving member (500) for rotating the rotatable member (494) is also visible.
• the cross- section of the wire itself may have a variety of cross-sections, e.g., round, oval, square, rectangular, triangular, hollow, etc. and other irregular shapes.
• Figure 24 illustrates another variation of a catheter tip (520) in which the structure used to expand and maintain the shape of the expanded catheter tip (520) comprises a stent-like structure (522).
• the stent-like structure (522) is included within (or attached to) the catheter wall (524).
• the strength of the structure (522) need not, of course, be of that needed in stent service, since the strength needed to hold the catheter open is much less than that needed to maintain the patency of an artery. Said another way: the structure (522) is fully retractable.
• Figure 25 shows still another variation of a catheter tip assembly (530) in which the structure used to expand and maintain the shape of the expanded catheter tip (532) comprises a stent- like structure (534).
• the stent-like structure (534) is bare but attached to the body of the catheter tip (530).
• the structure (534) may be self-expanding or expanded using a balloon or the like.
• the structure may be coated with a lubricious coating, e.g., such as a polymer, to increase the ease with which the structure (534) moves between the embolism and the vessel wall during introduction.
• the stent-like structures (522, 534) may be of any convenient form such as shown in the Figures or may be of another similar shape having the functions described above. Braided wires or ribbons or laser cut tubes are also appropriate.
• Figure 26 illustrates a method for utilizing the embolectomy device.

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