WO2019232507A1 - Système de retrait de caillot - Google Patents

Système de retrait de caillot Download PDF

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Publication number
WO2019232507A1
WO2019232507A1 PCT/US2019/035106 US2019035106W WO2019232507A1 WO 2019232507 A1 WO2019232507 A1 WO 2019232507A1 US 2019035106 W US2019035106 W US 2019035106W WO 2019232507 A1 WO2019232507 A1 WO 2019232507A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
proximal
distal body
junction
pull wire
Prior art date
Application number
PCT/US2019/035106
Other languages
English (en)
Inventor
Arthur John ULM, III
Original Assignee
Legacy Ventures LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/995,901 external-priority patent/US10258358B2/en
Priority claimed from US16/215,841 external-priority patent/US10321925B2/en
Application filed by Legacy Ventures LLC filed Critical Legacy Ventures LLC
Priority to EP19731111.1A priority Critical patent/EP3801307A1/fr
Publication of WO2019232507A1 publication Critical patent/WO2019232507A1/fr

Links

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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • 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
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

Definitions

  • the distal body has a relaxed state wherein the distal body has a first height and width and a collapsed state wherein the distal body has a second height and width, the second height less than said first height, the second width less than the first width.
  • the system further includes a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible material and configured to envelope the distal body when the distal body is in the collapsed state.
  • Each of the proximal memory metal strips has a proximal end and a distal end and preferably, in the relaxed state, each of the proximal ends of the proximal memory metal strips is located proximal relative to the proximal hub/junction.
  • a distal body attached to the pull wire comprising an interior, a proximal end, a distal end, a distal body length extending from the proximal end to the distal end, a proximal hub/junction (preferably in the form of a tube) forming the proximal end of the distal body, a basket comprised of a plurality of cells formed by a plurality of basket strips, a plurality of proximal strips, and, optionally a distal hub/junction (preferably in the form of a tube) forming a distal end of the basket, the basket comprising a basket interior, each proximal strip having a proximal end attached to the proximal hub/junction, and a distal end attached to a cell, the distal body having a relaxed state wherein the distal body has a first height and a first width, and a collapsed state wherein the distal body has a second height and a second width, the second height less
  • the basket includes an open distal end.
  • the proximal hub/junction is located approximately in the center of the first height and first width in the relaxed state.
  • the proximal hub/junction is located within 0.5 mm of the center of first width and the first height.
  • the catheter is comprised of a polymeric material (i.e., one or more polymeric materials such as silicone, PVC, latex rubber or braided nylon).
  • the pull wire is comprised of a biocompatible metallic material (e.g., a biocompatible metal or a biocompatible metal alloy).
  • the proximal hub/junction is located approximately in the center of the first height and first width in the relaxed state.
  • the catheter is comprised of a polymeric material (i.e., one or more polymeric materials such as silicone, PVC, latex rubber or braided nylon).
  • the pull wire is comprised of a biocompatible metallic material (e.g., a biocompatible metal or a biocompatible metal alloy).
  • the basket interior is substantially hollow.
  • each distal crown in the first and second pair of distal crowns forms part of an enlarged cell and further wherein the surface area of each enlarged cell in the relaxed state is at least twice as large as the surface area of each other individual cell of the basket and further wherein the enlarged cells are configured to allow a thrombus to pass therethrough and into the basket interior.
  • the pull wire is attached to the proximal hub/junction.
  • the basket, the proximal hub/junction and the proximal strips are comprised of a memory metal, wherein the proximal hub/junction comprises a proximal end and a distal end, and further wherein the proximal strips are integral with the distal end of the proximal hub/junction.
  • the framework of the distal body comprises a plurality of free distal crowns pointing generally in the distal direction and does not have any free proximal crowns pointing generally in the proximal direction.
  • the plurality of cells of the framework of the distal body are spaced about the distal body perimeter and the plurality of cells of the framework of the proximal body are spaced about the proximal body perimeter.
  • the system further comprises a catheter having an interior, a proximal end leading to the interior and a distal end leading to the interior, the catheter comprised of a biocompatible material and configured to envelop the distal body and the proximal body when the distal body and the proximal body are in the collapsed state.
  • the present disclosure provides a system for removing a blood clot from a human blood vessel, the system comprising: a pull wire having a pull wire proximal end, a pull wire distal end and a pull wire length extending from the pull wire proximal end to the pull wire distal end; a proximal body free floating over a fixed distance of the pull wire and comprising a proximal body interior, a proximal body perimeter, a proximal body proximal end, a proximal body open distal end, a proximal body length extending from the proximal body proximal end to the proximal body distal end, and a proximal body height and width perpendicular to the proximal body length, the proximal body comprising a framework comprised of a plurality of cells formed by a plurality of memory metal strips; a distal body comprising a distal body interior, a distal
  • FIG. 2C illustrates another side, perspective view of the memory metal tube of FIG. 1B after being cut by a laser; in FIG. 2C, the tube is rotated as compared to FIG. 2B.
  • FIG. 9, which has subparts (A)-(F), illustrates a side, elevation view of a claw of one embodiment of the present invention being closed by a claw actuator tube; in FIG. 9, the basket portion of the distal body is not shown for simplicity of illustration.
  • FIG. 12A illustrates a second, perspective view of the distal body of FIG. 11; the distal body is in what is referred to herein as“Orientation 2”.
  • FIG. 12B illustrates a proximal, elevation view of the proximal strips of the distal body of FIG. 11.
  • FIGs. 16A-H illustrate stepwise use of the distal body of FIG. 11 in retrieving a hard clot; the distal body is in Orientation 1.
  • FIGs. 19A-N illustrate stepwise use of the distal body of FIG. 11 in retrieving a deformable, cohesive adherent clot; the distal body is in Orientation 2.
  • FIG. 26 shows a perspective view of the distal end of the suction catheter of FIG. 24 being pushed into a clot; in FIG. 26, the user has locked the syringe lever at the desired volume.
  • FIG. 42 illustrates an exploded side perspective view of a clot retrieval system of another embodiment of the present invention that includes a proximal body that will be free- floating a fixed distance on the pull wire and a distal body that will not be free-floating on the pull wire; in FIG. 42, the proximal body and the distal body are in the relaxed state.
  • FIG. 43 A illustrates a side perspective view of the clot retrieval system of FIG. 42 with the distal body deployed from the catheter; in FIG. 43A, the distal body is in the relaxed state.
  • the claw 46 may be comprised of any number of proximal memory metal strips 40. Preferably, however, between 2 and 4 proximal memory metal strips 40 comprise the claw 46 (it being understood that the connector strips 48, if present, merely serve to tether the claw 46 to the proximal hub/junction 74). Preferably, the proximal memory metal strips 40 have a length of between about 10 and about 60 millimeters. The proximal memory metal strips 40 can be thought of as arms of the claw 46.
  • the distal body 22 further comprises an x-ray marker 64 that is more visible under x-ray as compared to the proximal memory metal strips 40 when the distal body 22 is located in a cranial blood vessel inside the body of a human and the x-ray is taken from outside the human’s body.
  • the x-ray markers 64 may be, for example, located at the welding or soldering site. In some cases, the increased thickness at the welding or soldering site may in of itself comprise the x-ray marker 64.
  • the x-ray marker 64 is comprised of a radiopaque material.
  • the surgeon may deploy the distal body 22 by, for example, moving the catheter 50 proximally so as to unsheathe the distal body 22 or by pushing the distal body 22 out of the catheter 50.
  • the system 200 may include a pull wire 202 having a proximal end 204 and a distal end 206, as described above, a distal body 216 attached to the pull wire 202, the distal body 216 comprising an interior 222, a proximal end 218, a distal end 220, a distal body length 226 extending from the proximal end 218 to the distal end 220, a distal body height 224, a proximal hub/junction 228 (preferably in the form of a tube and which has a proximal end 230 and a distal end 232) forming the proximal end 218 of the distal body 216, a basket 246 comprised of a plurality of cells/openings 248 formed by a plurality of basket strips 291 that preferably are comprised of a memory metal, optionally a distal hub/junction 236 that forms the distal end 220
  • the x-ray marker 244 is a radiopaque material.
  • radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with radiopaque filler, and the like.
  • the basket strips 291 are comprised of nitinol and the x-ray marker 244 is comprised of a material having a density greater than the nitinol.
  • the proximal and distal hubs/junctions/tube interiors 234 and 242 may comprise tantalum welded or otherwise attached to the interior 234 and 242 of the proximal and distal hubs/junctions/tubes 228 and 236.
  • FIGs. 11 and 14B illustrate a first, perspective view of one embodiment of a distal body 216 with twisting proximal strips 252, unattached distal-pointing crowns 258 that subtly curve inward and have x-ray markers 244, and enlarged openings/drop zones 262 in the basket 246 that allow the obstruction or other object 270 to enter.
  • the distal body 216 is in Orientation 1. (To prepare a basket 246 with unattached distal-pointing crowns 258 that curve inward toward the basket interior 292, a mandrel 900 such as that illustrated in FIGs. 30 and 31 may be used.
  • the third row is a single point, which represents the x-ray marker located at the bottom, distal, unattached distal-pointing crown 258D, 244; the reason that this third row of markers is a single point is that the top x-ray marker of the third row 258C, 244 is directly behind the bottom x- ray marker of the third row 258D, 244, and thus, hidden from view.
  • the fourth row is, as always, a single point, which represents the x-ray marker located in the distal tube 236, 244.
  • the surgeon concludes that the clot is a soft clot 270A that has entered into the distal body interior 222 and the surgeon removes the distal body 216 and the soft clot 270A, captured by the distal body 216, by moving the distal body 216 proximally out of the vessel 266, as shown in FIG. 15G.
  • the third row has two points, which represents the two x-ray markers located at the distal, unattached distal- pointing crowns 258C, 244 and 258D, 244; the reason that this third row of markers shows up as two points is that neither marker in the third row is hidden from view on the x-ray at this offset angle and the distal body 216 is not collapsed at the distal, unattached distal-pointing crowns 258C, 244 and 258D, 244.
  • the fourth row is, as always, a single point, which represents the x-ray marker located in the distal tube 236, 244.
  • FIGs. 18A-G illustrate stepwise use of the distal body 216 in retrieving a hard clot 270B in a human intracranial artery 266.
  • the distal body 216 is in Orientation 2.
  • the primary differences between FIGs 18A-G and FIGs. 16A-G is that the clot 270B enters the distal body interior 222 in an enlarged cell/drop zone 262A immediately distal to one of the proximal, unattached distal-pointing crowns 258A in FIGs. 18A-G, as compared to FIGs.
  • the second row has a single point, which corresponds to the bottom (in Orientation 2), proximal, unattached distal-pointing crown 258B, 244; the top (in Orientation 2), proximal, unattached distal-pointing crown 258A, 244 is located behind the bottom, proximal, unattached distal-pointing crown 258B, 244 and hidden from view.
  • the third row has two points, which correspond to the front (in Orientation 2) 258C, 244 and rear 258D, 244 (in Orientation 2), distal, unattached distal-pointing crowns, neither of which is blocked in this view.
  • FIGs. 20A, 20B and 20C show a distal body 216 that is similar to the distal body 216 of FIGs. 14A, 14B and 14C except that the distal body 216 of FIGs. 20A, 20B and 20C is slightly shorter and its unattached, distal-pointing crowns 258A, 258B, 258C, and 258D are closer to the proximal tube 228.
  • the shortened distal body 216 of FIGs. 20A, 20B and 20C is particularly adapted for tortuous blood vessels 266.
  • FIG. 21-29 show stepwise deployment of the distal body 216 of FIGs.
  • the clots 270A and 270B were then inserted into a vessel 266 having a diameter of 2 to 4 mm. (Only one clot 270A and 270B was located in the vessel 266 at a time). Angiograms were then performed to confirm occlusion. After waiting ten minutes after confirming occlusion, the distal bodies 216 of FIGs. 11-20 were then delivered distal to the clots 270A and 270B as described above and were used to retrieve the clots 270A and 270B as described in FIGs. 11-19.
  • the present disclosure provides a system 1250 for removing a blood clot 1330 from a human blood vessel
  • the distal body proximal end 1292 is located a second distance 1310 distal relative to the proximal body proximal end 1270, the second distance less 1310 than the first distance 1308.
  • the distal body distal end 1296 is preferably closer to the proximal body proximal end 1270 than in the deployed configuration.
  • the pull wire distal end 1258 and the distal body 1286 are configured to move proximally a fixed distance toward the proximal body proximal end 1270 when the distal body 1286 moves from the deployed configuration to the retracted configuration.
  • the proximal body 1262 is free floating when the thin segment 1326 passes through the tube interior, pushing the proximal bumper 1324 against the proximal body proximal junction 1272 is configured to move the proximal body distally 1262, pulling the distal bumper 1328 against the proximal body proximal junction 1272 is configured to move the proximal body 1262 proximally, pushing the pull wire 1254 distally is configured to move the distal body 1286 distally and pulling the pull wire 1254 proximally is configured to move the distal body 1286 proximally.
  • the proximal body 1262 further comprises a plurality of proximal strips also labelled 1348, each proximal body proximal strip 1348 having a distal end 1352 attached to a proximal crown 1354 of a cell of the proximal body 1262 and a proximal end 1350, the proximal ends 1350 of the proximal strips 1348 of the proximal body 1262 converging at the proximal body proximal junction 1272.
  • the framework 1302 of the distal body 1286 comprises a plurality of free distal crowns 1314 pointing generally in the distal direction, as seen in FIGs.
  • the framework 1302 of the distal body 1286 comprises a first pair of distal crowns 1314 not attached to another cell 1304 of the framework 1302 and pointing generally in the distal direction, the distal crowns 1314 in the first pair of distal crowns located approximately the same distance from the distal body proximal end 1292 and located between 150 degrees and 180 degrees relative to each other, as seen in FIGs. 40- 41.
  • the system 1250’ of FIGs. 42-44 further includes a pull wire 1256 attached to the distal body 1286.
  • the pull wire 1256 may include one or more of the features discussed with respect to FIGs. 1-41 above or FIGs. 1-144 of U.S. Patent No. 10,258,358, for example .
  • the pull wire 1256 is an extra long (exchange length) pull wire in which case the pull wire 1256 has a length of at least about 280 centimeters and the pull wire 1256 has a width of no more than about 0.014 inches, as described in U.S. Patent No.
  • the system 1250’ of FIGs. 42-44 further includes a proximal body 1262 that may include one or more of the features discussed with respect to FIGs. 33-41.
  • the proximal body 1262 is shown with a film 1370, which is optional.
  • the film 1370 if included, may be impermeable or permeable to red blood cells as described in U.S. Patent No. 10,258,358, for example .
  • the system 1250’ of FIGs. 42- 44 includes a proximal body 1262 that is i) free floating over the pull wire 1254 and ii) moved by a tube (inner tube 1356), and a distal body 1286 that is attached to and moves with the pull wire 1254.
  • An advantage of the system 1250’ of FIGs. 42-44 is that no handle or bumpers are needed, and the proximal body 1262 is deployed after the distal body 1286 is deployed, allowing the surgeon to use the proximal body 1262 as an optional, independently- deployed accessory to the distal body 1286, e.g., in the case of a clot 1330 that is particularly difficult to remove.
  • the outer tube 1362 is attached to neither the distal body 1286 nor the proximal body 1262 and the outer tube 1362 is freely moveable toward and away from the proximal body proximal end 1270 and the distal body proximal junction 1294 and that movement of the outer tube 1362 over the proximal body 1262 is configured to move the proximal body 1262 from the relaxed state to the collapsed state.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des dispositifs médicaux endovasculaires posés par cathéter. Les dispositifs peuvent comprendre un fil de traction relié à un corps proximal et un corps distal, qui peut être formé d'un panier ou d'une autre structure qui comprend une pluralité de cellules. Le corps distal peut se déplacer/s'articuler de manière proximale par rapport au corps proximal, et vers celui-ci. La présente invention concerne également des méthodes d'utilisation et des procédés de fabrication des dispositifs.
PCT/US2019/035106 2018-06-01 2019-06-03 Système de retrait de caillot WO2019232507A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19731111.1A EP3801307A1 (fr) 2018-06-01 2019-06-03 Système de retrait de caillot

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US15/995,901 2018-06-01
US15/995,901 US10258358B2 (en) 2014-01-03 2018-06-01 Clot retrieval system
US16/215,841 2018-12-11
US16/215,841 US10321925B2 (en) 2014-01-03 2018-12-11 Clot retrieval system

Publications (1)

Publication Number Publication Date
WO2019232507A1 true WO2019232507A1 (fr) 2019-12-05

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PCT/US2019/035106 WO2019232507A1 (fr) 2018-06-01 2019-06-03 Système de retrait de caillot

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WO (1) WO2019232507A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4144309A4 (fr) * 2020-04-27 2024-06-05 Lifetech Scientific (Shenzhen) Co., Ltd. Appareil d'élimination de thrombus

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130345739A1 (en) 2011-03-09 2013-12-26 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US20140005717A1 (en) * 2007-12-26 2014-01-02 Brian B. Martin Retrieval systems and methods for use thereof
US20140188127A1 (en) * 1997-11-12 2014-07-03 Capture Vascular, Inc. Medical device and method
CN106618676A (zh) * 2016-12-30 2017-05-10 上海加奇生物科技苏州有限公司 一种血管内血栓取出装置
US9827084B2 (en) * 2007-10-26 2017-11-28 Embolitech, Llc Intravascular guidewire filter system for pulmonary embolism protection and embolism removal or maceration
US20180116685A1 (en) * 2014-01-03 2018-05-03 Legacy Ventures, LLC Clot retrieval system
US10258358B2 (en) 2014-01-03 2019-04-16 Legacy Ventures LLC Clot retrieval system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140188127A1 (en) * 1997-11-12 2014-07-03 Capture Vascular, Inc. Medical device and method
US9827084B2 (en) * 2007-10-26 2017-11-28 Embolitech, Llc Intravascular guidewire filter system for pulmonary embolism protection and embolism removal or maceration
US20140005717A1 (en) * 2007-12-26 2014-01-02 Brian B. Martin Retrieval systems and methods for use thereof
US20130345739A1 (en) 2011-03-09 2013-12-26 Neuravi Limited Clot retrieval device for removing occlusive clot from a blood vessel
US20180116685A1 (en) * 2014-01-03 2018-05-03 Legacy Ventures, LLC Clot retrieval system
US10258358B2 (en) 2014-01-03 2019-04-16 Legacy Ventures LLC Clot retrieval system
CN106618676A (zh) * 2016-12-30 2017-05-10 上海加奇生物科技苏州有限公司 一种血管内血栓取出装置
WO2018120254A1 (fr) * 2016-12-30 2018-07-05 上海加奇生物科技苏州有限公司 Dispositif de récupération pour thrombus dans un vaisseau sanguin

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4144309A4 (fr) * 2020-04-27 2024-06-05 Lifetech Scientific (Shenzhen) Co., Ltd. Appareil d'élimination de thrombus

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