WO2020092253A2 - Introducer sheath with expandable introducer - Google Patents

Introducer sheath with expandable introducer Download PDF

Info

Publication number
WO2020092253A2
WO2020092253A2 PCT/US2019/058371 US2019058371W WO2020092253A2 WO 2020092253 A2 WO2020092253 A2 WO 2020092253A2 US 2019058371 W US2019058371 W US 2019058371W WO 2020092253 A2 WO2020092253 A2 WO 2020092253A2
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
introducer
plug
lumen
housing
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/US2019/058371
Other languages
English (en)
French (fr)
Other versions
WO2020092253A3 (en
Inventor
Tung T. LE
Sonny Tran
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.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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 Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Priority to EP24175579.2A priority Critical patent/EP4445940A3/en
Priority to CN202310377480.2A priority patent/CN116421854A/zh
Priority to EP19848832.2A priority patent/EP3873578B1/en
Priority to CN201980082825.3A priority patent/CN113226425B/zh
Priority to JP2021523798A priority patent/JP7539879B2/ja
Priority to US16/690,593 priority patent/US11779728B2/en
Publication of WO2020092253A2 publication Critical patent/WO2020092253A2/en
Publication of WO2020092253A3 publication Critical patent/WO2020092253A3/en
Anticipated expiration legal-status Critical
Priority to US18/375,902 priority patent/US12409297B2/en
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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Definitions

  • FIG . 12A illustrates a side view' of the system shown in FIG. 1.
  • the transient force to a portion of the sheath 12 allows for a lesser force to be applied to the sheath 12 than if the entirety of the sheath 12 were expanded at once.
  • the sliding motion of the plug 78 reduces static friction that may exist between the plug 78 and the interior surface of the sheath 12.
  • Tire sliding motion also reduces the possibility of the plug 78 becoming stuck in the lumen, due to the kinetic energy provided to the plug 78 and the reduction of adhesive forces that may exist between the outer surface of the plug 78 and the interior surface of the sheath if the plug 78 were deployed within the lumen.
  • the sheath 12 may be configured to partially return to a pre-expanded configuration, as discussed previously.
  • the difference in diameter between portion 134 and portion 130 may decrease the insertion push force of a delivery apparatus inserted through the sheath 12 after the introducer 14 and plug 78 have been removed from the sheath 12
  • FIG. 15A illustrates the system in the advanced configuration.
  • the introducer 174 and plug 170 may move to an advanced position, distal of the distal end 176 of the sheath 172 in a similar manner as discussed in regard to the embodiments of FIGS. I-T3B.
  • the plug 170 is positioned exterior of the lumen of the sheath 172
  • the plug 170 remains in the first position, and is flattened or in an undeployed or unexpanded configuration.
  • FIG. 16B illustrates the plug 182 in the second position, or in an expanded configuration, or deployed configuration.
  • the supports 198 of the plug 182 have self-expanded to a larger configuration outward from the introducer 186 to increase tire diameter of the plug 182 to be greater than the interior diameter of the sheath 184.
  • the supports 198 extend radially outward from the introducer 186.
  • the supports 198 bend to move the plug 182 from the first position to the second position.
  • the plug 182 in the second position has a length that is less than the length of tire sheath 184.
  • the plug 182 may be activ ated from the first position to the second position by being moved exterior of the lumen of the sheath 184, and the plug 182 may self-expand to the second position.
  • any of the systems, apparatuses, and methods disclosed herein may be modified to utilize self-expanding materials or structures, such as nitinol.
  • die plug 78 described in regard to FIGS. 1--I3B may be modified to be seif-expanding, and utilize a material such as nitinol.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/US2019/058371 2018-11-01 2019-10-28 Introducer sheath with expandable introducer Ceased WO2020092253A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP24175579.2A EP4445940A3 (en) 2018-11-01 2019-10-28 Introducer sheath with expandable introducer
CN202310377480.2A CN116421854A (zh) 2018-11-01 2019-10-28 具有可扩张引导器的引导器鞘筒
EP19848832.2A EP3873578B1 (en) 2018-11-01 2019-10-28 Introducer sheath with expandable introducer
CN201980082825.3A CN113226425B (zh) 2018-11-01 2019-10-28 具有可扩张引导器的引导器鞘筒
JP2021523798A JP7539879B2 (ja) 2018-11-01 2019-10-28 膨張可能イントロデューサを備えたイントロデューサシース
US16/690,593 US11779728B2 (en) 2018-11-01 2019-11-21 Introducer sheath with expandable introducer
US18/375,902 US12409297B2 (en) 2018-11-01 2023-10-02 Introducer sheath with expandable introducer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862754516P 2018-11-01 2018-11-01
US62/754,516 2018-11-01

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/690,593 Continuation US11779728B2 (en) 2018-11-01 2019-11-21 Introducer sheath with expandable introducer

Publications (2)

Publication Number Publication Date
WO2020092253A2 true WO2020092253A2 (en) 2020-05-07
WO2020092253A3 WO2020092253A3 (en) 2020-06-11

Family

ID=69467667

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/058371 Ceased WO2020092253A2 (en) 2018-11-01 2019-10-28 Introducer sheath with expandable introducer

Country Status (5)

Country Link
US (2) US11779728B2 (enExample)
EP (2) EP4445940A3 (enExample)
JP (1) JP7539879B2 (enExample)
CN (2) CN116421854A (enExample)
WO (1) WO2020092253A2 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024178193A1 (en) * 2023-02-23 2024-08-29 Edwards Lifesciences Corporation Expandable introducer
WO2025219960A1 (en) * 2024-04-19 2025-10-23 Three Peaks Medical Pty Ltd Introducer sheath assembly with expanding actuator

Families Citing this family (8)

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Publication number Priority date Publication date Assignee Title
US10912919B2 (en) 2017-01-23 2021-02-09 Edwards Lifesciences Corporation Expandable sheath
EP4445940A3 (en) * 2018-11-01 2025-01-01 Edwards Lifesciences Corporation Introducer sheath with expandable introducer
EP3893818B1 (en) * 2018-12-12 2024-02-14 Edwards Lifesciences Corporation Combined introducer and expandable sheath
WO2022098720A1 (en) * 2020-11-04 2022-05-12 Edwards Lifesciences Corporation Systems, tools, and methods for delivering implants and catheters for a prosthetic valve
WO2022261372A1 (en) * 2021-06-10 2022-12-15 Edwards Lifesciences Corporation Expandable sheath for introducting an endovascular delivery device into a body
EP4482433A4 (en) * 2022-02-25 2026-02-25 Foldax Inc SYSTEM AND METHODS FOR TRANSCATHETER VALVE INTRODUCTION
WO2024263844A1 (en) * 2023-06-22 2024-12-26 Edwards Lifesciences Corporation Pre-dilated expandable sheath with protective cover
WO2025158334A1 (en) * 2024-01-24 2025-07-31 Medtronic, Inc. Devices and methods for loading a transfer sleeve over a capsule of a medical device delivery system

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US12409297B2 (en) 2025-09-09
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US11779728B2 (en) 2023-10-10

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