WO2016022512A1 - Reformable guidewire tip - Google Patents

Reformable guidewire tip Download PDF

Info

Publication number
WO2016022512A1
WO2016022512A1 PCT/US2015/043521 US2015043521W WO2016022512A1 WO 2016022512 A1 WO2016022512 A1 WO 2016022512A1 US 2015043521 W US2015043521 W US 2015043521W WO 2016022512 A1 WO2016022512 A1 WO 2016022512A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
tip
coil
distal end
reformable
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2015/043521
Other languages
English (en)
French (fr)
Inventor
Bruce H. Asmus
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiovascular Systems Inc
Original Assignee
Cardiovascular Systems Inc
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
Application filed by Cardiovascular Systems Inc filed Critical Cardiovascular Systems Inc
Priority to CA2956680A priority Critical patent/CA2956680A1/en
Priority to JP2017506360A priority patent/JP6868551B2/ja
Priority to AU2015301290A priority patent/AU2015301290A1/en
Priority to EP15829252.4A priority patent/EP3185787B1/en
Priority to CN201580041956.9A priority patent/CN106572865B/zh
Publication of WO2016022512A1 publication Critical patent/WO2016022512A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A61B2017/00871—Material properties shape memory effect polymeric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320766—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials

Definitions

  • the disclosure relates to devices and methods using guidewires, for example intravascular procedures, e.g., removing tissue from body passageways, such as removal of atherosclerotic plaque from arteries with, e.g., a rotational atherectomy device. More specifically, the disclosure provides a guidewire tip that is reformable and, therefore, resistant to damaging deformation.
  • a variety of techniques and instruments have been developed for use in the removal or repair of tissue in arteries and similar body passageways.
  • a frequent objective of such techniques and instruments is the removal of atherosclerotic plaque in a patient's arteries.
  • Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (i.e., under the endothelium) of a patient's blood vessels.
  • Atheromas restrict the flow of blood, and therefore often are referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material. If left untreated, such stenoses can cause angina, hypertension, myocardial infarction, strokes and the like.
  • Atherectomy devices have been developed for attempting to remove some or all of such stenotic material.
  • a rotating burr covered with an abrasive cutting material such as diamond grit (diamond particles or dust) is carried at the distal end of a flexible, rotatable drive shaft.
  • U.S. Pat. No. 5,314,438 shows another atherectomy device having a rotatable drive shaft with a section of the drive shaft having an enlarged diameter, at least a segment of this enlarged diameter section being covered with an abrasive material to define an abrasive segment of the drive shaft.
  • the abrasive segment When rotated at high speeds, the abrasive segment is capable of removing stenotic tissue from an artery.
  • Intravascular procedures for example and without limitation, rotational atherectomy systems, require a guidewire.
  • Known guidewires used in traversing blood vessels may bend and may ultimately deform permanently during a procedure and, therefore, become unusuable as well as potentially harmful to the patient. In this case, deformed guidewires must be removed and a replacement guidewire threaded to the region of interest within a patient's vasculature.
  • the guidewire is used in a high-speed atherectomy device that involves an eccentric abrasive element, having a center of mass that is radially positioned outwardly away from the rotational axis of the drive shaft to which the eccentric abrasive element is attached.
  • a guidewire that comprises a tip that is capable of elastic deformation caused by very high forces as described supra, but also capable of returning and recovering back to the original undeformed shape and structure.
  • the reformable tip comprises an inner nitinol support coil, wherein the reformable tip may be attached to a larger proximal core for improved kink resistance and support for delivering adjunctive devices.
  • an inner support ribbon coil constructed of a shape-memory material, e.g., Nitinol, may be wrapped with a braided coil and/or a polymer sleeve.
  • the braided coil and/or polymer sleeve may serve the same function as the inner support ribbon coil and replace the inner support ribbon coil. The resulting tip is more flexible with reduced risk of perforation than known guidewire tips.
  • Figure 1 A illustrates one embodiment of the present invention in cross-sectional and cutaway view
  • Figure IB illustrates one embodiment of a shape-memory ribbon coil of the present invention in side view
  • Figure 2A illustrates one embodiment of a braided coil of the present invention in side view
  • Figure 2B illustrates one embodiment of the present invention in cross-sectional and cutaway view
  • Figure 3 illustrates one embodiment of the present invention in cross-sectional and cutaway view
  • Figure 1 A illustrates one embodiment of the present invention, comprising a cutaway view of a guidewire 100 with a core 102 extending proximally to a proximal end available for manipulation by the operator (not shown but is as well-known to the skilled artisan).
  • Core 102 further comprises a distal end 104.
  • Reformable tip 106 comprises a distal end 109, distal end comprising a distal tip 110 disposed thereon and which may be radiopaque. Reformable tip 106 further comprises a flattened shape memory material support coil 1 12, support coil 1 12 comprising a proximal end 114 and a distal end 1 16, proximal end 1 14 in attached disposition with the distal end of core 109 at attachment point 115.
  • core 102 Surrounding at least part of the core 102 and the flattened material support coil 1 12 is a spring coil 1 18, at least a portion of which may be radiopaque.
  • core 102 may comprise an outer diameter that is smaller than an inner diameter of support coil 1 12 at attachment point 1 15.
  • core 102 may comprise an outer diameter that is larger than the inner diameter of support coil 1 12 at attachment point 115.
  • core 102 may comprise an outer diameter that is larger than the outer diameter of support coil 1 12 at attachment point 115.
  • Figure IB illustrates the flattened material support coil 112 in closer detail.
  • the shape memory material has been flattened to a desired thickness and cut to a desired width. Then, the shape memory material, thus cut, has been rolled and set or trained at high temperatures into the coiled structure of Fig. IB.
  • One embodiment of the coil 1 12 comprises the coil material having a thickness of 0.00175 inches, with a nominal inner diameter after shape setting in the coil form of approximately 0.0058 inches, though the skilled artisan will recognize the varying dimensions of the coil material, including the pitch, each such equivalent dimensional combination is within the scope of the present invention.
  • Coil 112 is illustrated as comprising a left-hand winding, though a right-hand winding may also be used.
  • the spring coil 118 which surrounds the coil 112 comprises an opposite winding, i.e., a right- hand winding.
  • FIG. 2A and 2B an alternate embodiment of the inventive guidewire 200 is illustrated.
  • This embodiment is identical to that of Figures 1A and IB except that a loose braid 202 comprising stainless steel, a polymer or a shape memory material, or a combination thereof, is provided along the reformable tip 106 from the distal end of the support coil 109 to the proximal end of the support coil 114.
  • the loose braid 202 may be applied around external surface 120 of the support coil 112 with the spring coil 1 18 surrounding the loose braid 202 and support coil 1 12.
  • the loose braid 202 may be disposed between wire turns of the support coil 112.
  • the loose braid 202 may be employed in guidewire 200 instead of the support coil 1 12, serving the same function as the support coil 112 embodiment.
  • Figure 3 illustrates yet another embodiment of a guidewire 300 of the present invention.
  • a polymer sleeve 302 is provided along and the reformable tip 106.
  • Polymer sleeve 302 may comprise nylon, pebax, fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE) and/or perfluoroalkoxy polymer resin (PFA).
  • FEP fluorinated ethylene propylene
  • PTFE polytetrafluoroethylene
  • PFA perfluoroalkoxy polymer resin
  • the polymer sleeve 302 may cover the external surface 120 of the support coil 1 12, with the spring coil 118 surrounding the support coil 112 and polymer sleeve 302.
  • the polymer sleeve 302 may be disposed over the wire turns of the support coil 1 12 along the corresponding length of the reformable tip 106. Still more alternatively, the wire turns of support coil 112 may be embedded within a polymer sleeve. Still more alternatively, the polymer sleeve 302 may be employed in guidewire 300 instead of the support coil 1 12, serving the same function as the embodiment having the support coil 112.
  • inventive guidewire and reformable tip thereof may comprise a hydrophilic coating along at least the reformable tip 106 and in certain embodiments along the length of the guidewire, and may further comprise a coating of silicone over the hydrophilic coating and/or along the length of the guidewire. This coating treatment assists and eases positioning of the guidewire as well as provides increased deliverability of adjunctive devices along the positioned guidewire.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
PCT/US2015/043521 2014-08-05 2015-08-04 Reformable guidewire tip Ceased WO2016022512A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2956680A CA2956680A1 (en) 2014-08-05 2015-08-04 Reformable guidewire tip
JP2017506360A JP6868551B2 (ja) 2014-08-05 2015-08-04 変形可能なガイドワイヤの先端
AU2015301290A AU2015301290A1 (en) 2014-08-05 2015-08-04 Reformable guidewire tip
EP15829252.4A EP3185787B1 (en) 2014-08-05 2015-08-04 Reformable guidewire tip
CN201580041956.9A CN106572865B (zh) 2014-08-05 2015-08-04 可改造的引导线末端

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462033346P 2014-08-05 2014-08-05
US62/033,346 2014-08-05
US14/816,367 2015-08-03
US14/816,367 US10806905B2 (en) 2014-08-05 2015-08-03 Reformable guidewire tip

Publications (1)

Publication Number Publication Date
WO2016022512A1 true WO2016022512A1 (en) 2016-02-11

Family

ID=55264406

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/043521 Ceased WO2016022512A1 (en) 2014-08-05 2015-08-04 Reformable guidewire tip

Country Status (7)

Country Link
US (1) US10806905B2 (enExample)
EP (1) EP3185787B1 (enExample)
JP (1) JP6868551B2 (enExample)
CN (1) CN106572865B (enExample)
AU (1) AU2015301290A1 (enExample)
CA (1) CA2956680A1 (enExample)
WO (1) WO2016022512A1 (enExample)

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WO2021257257A3 (en) * 2020-06-19 2022-01-20 Becton, Dickinson And Company Vascular access instrument and related devices and methods

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US12558175B2 (en) 2021-08-12 2026-02-24 Imperative Care, Inc. Multi catheter method of performing a robotic neurovascular procedure
US12440289B2 (en) 2022-08-01 2025-10-14 Imperative Care, Inc. Method of priming an interventional device assembly
US12564458B2 (en) 2022-08-01 2026-03-03 Imperative Care, Inc. Method of robotically driving a multi catheter assembly above the aortic arch
US12447317B2 (en) 2022-08-01 2025-10-21 Imperative Care, Inc. Method of priming concentrically stacked interventional devices
US12564414B2 (en) 2022-08-01 2026-03-03 Imperative Care, Inc. Method of supra-aortic access for a neurovascular procedure
US12419703B2 (en) 2022-08-01 2025-09-23 Imperative Care, Inc. Robotic drive system for achieving supra-aortic access
US12446979B2 (en) 2022-08-01 2025-10-21 Imperative Care, Inc. Method of performing a multi catheter robotic neurovascular procedure
US20240041480A1 (en) 2022-08-02 2024-02-08 Imperative Care, Inc. Multi catheter system with integrated fluidics management
EP4626353A1 (en) 2022-12-01 2025-10-08 Imperative Care, Inc. Controller for robotic catheter drive system
US12433702B2 (en) 2022-12-01 2025-10-07 Imperative Care, Inc. Telescoping drive table
US12377206B2 (en) 2023-05-17 2025-08-05 Imperative Care, Inc. Fluidics control system for multi catheter stack
CN121586597A (zh) 2023-05-31 2026-02-27 因普瑞缇夫护理公司 通过无菌区域屏障的磁连接
USD1102447S1 (en) 2023-11-30 2025-11-18 Imperative Care, Inc. Display screen or portion thereof with graphical user interface

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See also references of EP3185787A4

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021257257A3 (en) * 2020-06-19 2022-01-20 Becton, Dickinson And Company Vascular access instrument and related devices and methods

Also Published As

Publication number Publication date
EP3185787B1 (en) 2022-03-09
AU2015301290A1 (en) 2017-02-09
US10806905B2 (en) 2020-10-20
CA2956680A1 (en) 2016-02-11
CN106572865B (zh) 2020-10-30
EP3185787A1 (en) 2017-07-05
JP6868551B2 (ja) 2021-05-12
US20160038719A1 (en) 2016-02-11
JP2017527347A (ja) 2017-09-21
EP3185787A4 (en) 2018-03-28
CN106572865A (zh) 2017-04-19

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