WO2020064660A1 - Systems, devices, and methods for aspirating biological material from a body lumen - Google Patents

Systems, devices, and methods for aspirating biological material from a body lumen Download PDF

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Publication number
WO2020064660A1
WO2020064660A1 PCT/EP2019/075579 EP2019075579W WO2020064660A1 WO 2020064660 A1 WO2020064660 A1 WO 2020064660A1 EP 2019075579 W EP2019075579 W EP 2019075579W WO 2020064660 A1 WO2020064660 A1 WO 2020064660A1
Authority
WO
WIPO (PCT)
Prior art keywords
pump
lumen
pump chamber
fluid
intraluminal
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/EP2019/075579
Other languages
English (en)
French (fr)
Inventor
Princeton Saroha
Jeremy Stigall
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.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
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 Koninklijke Philips NV filed Critical Koninklijke Philips NV
Priority to US17/276,345 priority Critical patent/US12558473B2/en
Priority to CN201980063464.8A priority patent/CN112770792B/zh
Priority to JP2021516811A priority patent/JP7462616B2/ja
Priority to EP19779781.4A priority patent/EP3856269A1/en
Publication of WO2020064660A1 publication Critical patent/WO2020064660A1/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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/743—Suction control by changing the cross-section of the line, e.g. flow regulating 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/741—Suction control with means for varying suction manually
    • A61M1/7413—Suction control with means for varying suction manually by changing the cross-section of the line
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A61M1/774—Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/81—Piston pumps, e.g. syringes
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/82—Membrane pumps, e.g. bulbs
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A61M1/772—Suction-irrigation systems operating alternately
    • 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
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/058—General characteristics of the apparatus combined with other kinds of therapy with ultrasound therapy
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3337—Controlling, regulating pressure or flow by means of a valve by-passing a pump
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0693—Brain, cerebrum
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1003—Spinal column
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1039—Lungs
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/106—Small intestine
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1075—Gall bladder
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract
    • A61M2210/1082—Kidney
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

Definitions

  • a pumping system may include a handheld, disposable pump that includes an actuator and a pump chamber in communication with an intraluminal device inserted into the lumen of the patient.
  • Thrombectomy is commonly performed using a vacuum pump system, isolated from other treatments, in conjunction with a catheter. Aside from minimally invasive surgical intervention such as balloon angioplasty and various forms of atherectomy, other common methods include: open heart surgery and anticoagulation regimens.
  • Existing pump systems often include reusable large footprint pumps that can be expensive to purchase and maintain, and difficult to sterilize for use with other patients.
  • some existing pump systems may lack power efficiency and/or consistent pump pressure due to the simplicity of the design.
  • an irregular pump vacuum cycle can produce periodic pressure spikes that, while short in duration, can be sufficiently high to cause a vessel to collapse.
  • the disposable pump system comprises a pump chassis that is sized and shaped to be manually supported by a user.
  • the pump chassis houses and/or couples to an inlet, pump chamber, a motor or actuator, and an outlet.
  • the components of the pump and sized, shaped, and arranged to conserve size and weight and reduce cost while maintaining sufficiently high vacuum strength for use in aspiration thrombectomy.
  • an intraluminal system for aspirating biological material from a lumen of a patient.
  • the system includes a disposable intraluminal device comprising a distal portion configured to be positioned within the lumen of the patient and a proximal portion in fluid communication with the distal portion and positioned outside of the patient; and a disposable pump configured to aspirate the biological material from the lumen of the patient, the disposable pump coupled to the proximal portion of the intraluminal device and comprising a pump chassis that houses: an inlet port configured to sealably attach to the proximal portion of the intraluminal device; an outlet port configured to expel the aspirated biological from the pump; and a flow controller configured to adjust the fluid flow through the pump, wherein the pump chassis is sized and shaped to be manually supported by a user.
  • the flow controller comprises a mechanical valve that is manually controllable by a user.
  • the flow controller comprises an electronic flow control device.
  • the pump chassis further houses a flow meter configured to detect a fluid flow through the pump and to provide an indication of the fluid flow.
  • the flow meter comprises an electronic flow meter, and wherein the flow meter is in communication with the flow controller to provide feedback to the flow controller.
  • the flow meter and flow controller are configured to operate in a proportional-integral-derivative arrangement.
  • the flow controller is configured to repeatedly open and close to generate pulses of fluid pressure within the lumen of the patient.
  • the pump chassis further houses: an actuator; a first pump chamber; a second pump chamber separate from the first pump chamber; and a dual displacement adapter coupled to the actuator such that the actuator is configured to drive the dual displacement adapter to pump fluid through each of the first pump chamber and the second pump chamber.
  • the disposable intraluminal device comprises a fluid delivery lumen and an aspiration lumen separate from the fluid delivery lumen
  • the pump chassis further houses: a first pump chamber; a second pump chamber separate from the first pump chamber; a distal outlet in communication with the fluid delivery lumen of the disposable intraluminal device and the first pump chamber; and a distal inlet in communication with the aspiration lumen of the disposable intraluminal device and the second pump chamber, a proximal inlet in communication with the first pump chamber; and a proximal outlet in communication with the second pump chamber
  • the pump is configured to pump a fluid from a fluid source coupled to the proximal inlet to the lumen of the patient through the first pump chamber, and wherein the pump is configured to aspirate the biological material from the lumen of the patient through the second pump chamber.
  • an intraluminal system for aspirating biological material from a lumen of a patient.
  • the system includes a disposable intraluminal device comprising a distal portion configured to be positioned within the lumen of the patient and a proximal portion in fluid communication with the distal portion and positioned outside of the patient; and a pump chassis that houses: a first pump chamber; a second pump chamber separate from the first pump chamber; an actuator; and a dual displacement adapter coupled to the actuator such that the actuator is configured to drive the dual displacement adapter to pump fluid through each of the first pump chamber and the second pump chamber, wherein the pump chassis is configured to sealably attach to the proximal portion of the disposable intraluminal device, wherein the actuator is configured to drive the dual displacement adapter to aspirate the biological material through at least one of the first pump chamber or the second pump chamber, and wherein the actuator and dual displacement adapter are disposed within the pump chassis, and wherein the pump chassis is sized and shaped to be manually supported by
  • the dual displacement adapter is configured to pump a fluid to the distal portion of the disposable intraluminal device through the first pump chamber, and to aspirate the biological material through the second pump chamber.
  • the dual displacement adapter is configured to pump fluid through each of the first pump chamber and the second pump chamber in an alternating fashion.
  • the dual displacement adapter comprises a cam coupled to a first piston in communication with the first pump chamber and a second piston in communication with the second pump chamber.
  • the dual displacement adapter comprises a plurality of gears configured to distribute torque from the actuator to a first pump member in communication with the first pump chamber and a second pump member in communication with the second pump chamber.
  • an intraluminal system for aspirating biological material from a lumen of a patient.
  • the system includes a disposable intraluminal device comprising a distal portion configured to be positioned within the lumen of the patient and a proximal portion in fluid communication with the distal portion and positioned outside of the patient, wherein the disposable intraluminal device comprises a fluid delivery lumen and an aspiration lumen separate from the fluid delivery lumen; and a disposable pump configured to deliver a fluid to the lumen of the patient and aspirate the biological material from the lumen of the patient, the disposable pump coupled to the proximal portion of the intraluminal device and comprising a pump chassis that houses: a first pump chamber and a second pump chamber separate from the first pump chamber; a distal outlet in communication with the fluid delivery lumen of the disposable intraluminal device and the first pump chamber; and a distal inlet in communication with the aspiration lumen of the disposable intraluminal device and the second pump chamber, a
  • the proximal inlet is in communication with the proximal outlet to recycle aspirated fluid from the second pump chamber to the lumen of the patient through the first pump chamber.
  • the system further comprises a filter disposed between the proximal outlet and the proximal inlet.
  • the proximal inlet is in communication with a fluid reservoir, and wherein the proximal outlet is in communication with a waste receptacle separate from the fluid reservoir.
  • the disposable intraluminal device comprises a sheath surrounding the fluid delivery lumen, wherein the aspiration lumen is coaxially disposed within the fluid delivery lumen, and wherein a distal tip of the sheath includes a narrowing taper.
  • the disposable intraluminal device comprises a sheath surrounding the fluid delivery lumen, wherein the aspiration lumen is coaxially disposed within the fluid delivery lumen, and wherein a distal tip of the sheath includes a widening taper.
  • FIG. 1 is diagrammatic schematic view of a disposable pump system according to some embodiments of the present disclosure.
  • FIG. 2 is diagrammatic schematic view of disposable pump according to some embodiments of the present disclosure.
  • Fig. 6 is diagrammatic schematic view of a disposable pump according to some embodiments of the present disclosure.
  • the flexible elongate member 130 can include one or more metallic and/or polymer coils. All or a portion of the flexible elongate member 130 may have any suitable geometric cross-sectional profile (e.g., circular, oval, rectangular, square, elliptical, etc.) or non geometric cross-sectional profile.
  • the flexible elongate member 130 can have a generally cylindrical profile with a circular cross-sectional profile that defines an outer diameter of the flexible elongate member 130.
  • the occlusion 106 of the anatomy 102 is generally representative of any blockage or other structural arrangement that results in a restriction to the flow of fluid through the lumen 104, for example, in a manner that is deleterious to the health of the patient.
  • the occlusion 106 narrows the lumen 104 such that the cross-sectional area of the lumen 104 and/or the available space for fluid to flow through the lumen 104 is decreased.
  • the anatomy 102 is a blood vessel
  • the occlusion 106 may be a result of a blood clot (thombus), plaque buildup, including without limitation plaque components such as fibrous, fibro-lipidic (fibro fatty), necrotic core, or calcified (dense calcium).

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
PCT/EP2019/075579 2018-09-28 2019-09-24 Systems, devices, and methods for aspirating biological material from a body lumen Ceased WO2020064660A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US17/276,345 US12558473B2 (en) 2018-09-28 2019-09-24 Systems, devices, and methods for aspirating biological material from a body lumen
CN201980063464.8A CN112770792B (zh) 2018-09-28 2019-09-24 用于从身体管腔中抽吸生物物质的系统、设备和方法
JP2021516811A JP7462616B2 (ja) 2018-09-28 2019-09-24 体腔から生物学的物質を吸引するためのシステム、デバイス及び方法
EP19779781.4A EP3856269A1 (en) 2018-09-28 2019-09-24 Systems, devices, and methods for aspirating biological material from a body lumen

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862738691P 2018-09-28 2018-09-28
US62/738,691 2018-09-28

Publications (1)

Publication Number Publication Date
WO2020064660A1 true WO2020064660A1 (en) 2020-04-02

Family

ID=68104573

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2019/075579 Ceased WO2020064660A1 (en) 2018-09-28 2019-09-24 Systems, devices, and methods for aspirating biological material from a body lumen

Country Status (5)

Country Link
US (1) US12558473B2 (https=)
EP (1) EP3856269A1 (https=)
JP (1) JP7462616B2 (https=)
CN (1) CN112770792B (https=)
WO (1) WO2020064660A1 (https=)

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US11298043B2 (en) 2016-08-30 2022-04-12 The Regents Of The University Of California Methods for biomedical targeting and delivery and devices and systems for practicing the same
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US12558473B2 (en) 2026-02-24
EP3856269A1 (en) 2021-08-04
CN112770792B (zh) 2024-09-27
JP2022501130A (ja) 2022-01-06
CN112770792A (zh) 2021-05-07
JP7462616B2 (ja) 2024-04-05
US20220040394A1 (en) 2022-02-10

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