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WO2025230535A1 - Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine - Google Patents

Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine

Info

Publication number
WO2025230535A1
WO2025230535A1 PCT/US2024/027581 US2024027581W WO2025230535A1 WO 2025230535 A1 WO2025230535 A1 WO 2025230535A1 US 2024027581 W US2024027581 W US 2024027581W WO 2025230535 A1 WO2025230535 A1 WO 2025230535A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
outer housing
biopsy device
drive shaft
fine needle
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.)
Pending
Application number
PCT/US2024/027581
Other languages
English (en)
Inventor
Feipeng Guo
Chen Chen
Rongjie LIANG
Bo Yan
Xin YUE
Yuhao ZHANG
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.)
Bard Peripheral Vascular Inc
Original Assignee
Bard Peripheral Vascular 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 Bard Peripheral Vascular Inc filed Critical Bard Peripheral Vascular Inc
Priority to PCT/US2024/027581 priority Critical patent/WO2025230535A1/fr
Publication of WO2025230535A1 publication Critical patent/WO2025230535A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms

Definitions

  • the present specification generally relates to biopsy devices and, more specifically, to biopsy devices for fine needle aspiration biopsy procedures capable of aspiration, rotation and thrusting of needles.
  • Fine needle aspiration biopsy is the standard of care for thyroid pathology diagnosis.
  • the needle punctures the skin and is navigated to the target nodule under the guidance of ultrasound equipment, then the inner stylet will be removed, the needle tip will thrust back and forth inside of nodule to scratch and cut off cells sample for pathological diagnosis.
  • Multiple punctures (2-5 needles) and repeated thrusting of each FN are typically performed due to insufficient specimen collected from each puncture alone.
  • aspiration may be applied to the needle to increase the sampling volume. If needed, the needle may be manually rotated during the sampling procedure to allow the needle tip to cut/crush more cells off for pathology diagnosis. To apply suction, a third hand may be needed to generate the suction.
  • a fine needle biopsy device includes an outer housing having a distal end and a needle connector that is connected to the distal end of the outer housing.
  • the needle connector is configured to connect to a needle.
  • a vacuum chamber is carried by the outer housing and fluidly connected to the needle connector.
  • An inner housing is slidably received within an opening through the outer housing.
  • a motor is carried by the inner housing. The motor is operably connected to the needle connector by a drive shaft that extends into the vacuum chamber. The inner housing moves axially relative to the outer housing to move the drive shaft between a release position and an aspiration position.
  • a fine needle biopsy device includes a first housing portion and a second housing portion.
  • the first and second housing portions are telescopically connected together such that the second housing portion moves axially relative to the first housing portion between a release position and an aspiration position.
  • a needle connector is connected to a distal end of the first housing portion.
  • the needle connector is configured to connect to a needle.
  • a vacuum chamber is carried by the first housing portion and fluidly connected to the needle connector.
  • a motor moves with the second housing portion between the release position and the aspiration position, the motor operably connected to the needle connector by a drive shaft that extends into the vacuum chamber.
  • FIG. 1 schematically depicts a section view of a fine needle biopsy device with motor and vacuum chamber in an aspiration configuration, according to one or more embodiments shown and described herein;
  • FIG. 2 schematically depicts a cam and follower arrangement for use in rotating and thrusting a fine needle with the fine needle biopsy device of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 3 schematically depicts a front view of an embodiment of a sleeve cover for use in engaging a drive shaft connected to a motor of the fine needle biopsy device of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 4 schematically depicts a drive shaft that connects to a motor of the fine needle biopsy device of FIG. 1, according to one or more embodiments shown and described herein;
  • FIG. 5 schematically depicts the fine needle biopsy device of FIG. 1 in a release position, according to one or more embodiments shown and described herein;
  • FIG. 6 schematically depicts another fine needle biopsy device with a moveable button, according to one or more embodiments shown and described herein;
  • FIG. 7 schematically depicts another fine needle biopsy device with a preloaded spring, according to one or more embodiments shown and described herein;
  • FIG. 8 schematically depicts the fine needle biopsy device of FIG. 7 in use, according to one or more embodiments shown and described herein;
  • FIG. 9 schematically depicts the fine needle biopsy device of FIG. 7 in use, according to one or more embodiments shown and described herein;
  • FIG. 10 schematically depicts the fine needle biopsy device of FIG. 7 in use, according to one or more embodiments shown and described herein. DETAILED DESCRIPTION
  • Embodiments described herein are generally directed to a fine needle biopsy device that includes an outer housing having a distal end and a needle connector that is connected to the distal end of the outer housing.
  • the needle connector is configured to connect to a needle.
  • a vacuum chamber is carried by the outer housing and is fluidly connected to the needle connector.
  • An inner housing is slidably received within an opening through the outer housing.
  • a motor is carried by the inner housing. The motor is operably connected to the needle connector by a drive shaft that extends into the vacuum chamber. The inner housing moves axially relative to the outer housing to move the drive shaft between a release position and an aspiration position.
  • distal and proximal are with respect to a person using the biopsy device.
  • distal is farther from the user and the term “proximal” is nearer to the user.
  • axial direction or “longitudinal direction” are used interchangeably to refer to the elongated direction of the biopsy device parallel to a biopsy needle and the term “lateral direction” is the direction transverse to the longitudinal direction.
  • a biopsy device 10 includes an outer housing 12 and an inner housing 14 that is slidable relative to the outer housing 12 within an opening 16 through the outer housing 12.
  • a proximal portion 18 of the inner housing 14 extend outward beyond a terminal end 20 of the outer housing 12.
  • the biopsy device 10 further includes an actuation device 22 that connects the outer housing 12 and the inner housing 14, an inner sleeve 24, a motor assembly 26, a switch 28 and a battery 30.
  • the actuation device 22 includes a lever 32 including a first articulation portion 34 and a second articulation portion 36 that is pivotally connected to the first articulation portion 34 at a pivot location 38.
  • the first articulation portion 34 is pivotally connected to a first pivot mount 40 that is, in turn, fixedly mounted to the outer housing 12.
  • the second articulation portion 36 is pivotally connected to a second pivot mount 42 that is, in turn, fixedly mounted to the inner housing 14.
  • first and second articulation portions 34 and 36 pivot relative to each other, thereby shortening or elongating the length between the first and second pivot mounts 40 and 42 and sliding one or both of the outer housing 12 and inner housing 14 relative to the other.
  • the inner sleeve 24 is located within the opening 16 through the outer housing 12 at a distal end 46 of the outer housing 12.
  • the inner sleeve 24 may include a needle connector 48 that extends out of the distal end 46 of the outer housing 12.
  • the needle connector 48 is configured to connect to a hollow needle using any suitable connections, such as a Luer-type connection.
  • the inner sleeve 24 includes a barrel 50 that forms a vacuum chamber 51 in which a negative pressure can be generated.
  • negative pressure negative pressure
  • suction vacuum
  • partial vacuum may be used interchangeably and refer to a force over an area produced by a difference in pressure.
  • the inner sleeve 24 may further include a thrusting pin 52 that is received within a thrusting groove 54 provided within the outer housing 12.
  • the outer housing may include the thrusting pin and the inner sleeve may include the thrusting groove.
  • the inner sleeve 24 and the outer housing 12 may have cooperating thrusting structures 52 and 54 that cause the inner sleeve 24 including the needle connector 48 to translate back and forth in a axial direction of the biopsy device 10.
  • the thrusting pin 52 may be located in the thrusting groove 54 that has a bend 58 such that the thrusting pin 52 and the inner sleeve 24 follow the contour of the thrusting groove 54 as the inner sleeve 24 rotates relative to the outer housing 12.
  • the shape of the thrusting groove 54 forms a track that causes the inner sleeve 24 to move axially distally and proximally in a cam and follower arrangement providing a thrusting motion for the needle connector 48 and needle held by the needle connector 48.
  • the motor assembly 26 is provided to rotate the inner sleeve 24.
  • the motor assembly 26 is provided in the inner housing 14 and includes a motor 60 and a drive shaft 62 that is in-line with the motor 60.
  • the drive shaft 62 extends through and mates with an opening 64 through a sleeve cover 66 that is connected to a proximal end 68 of the inner sleeve 24.
  • the drive shaft 62 and sleeve cover 66 are engaged such that rotation of the drive shaft 62 by the motor 60 also rotates the inner sleeve 24, which moves the thrusting pin 52 within the thrusting groove 54.
  • the sleeve cover 66 may include the opening 64 that is non-circular including notches 68 that receives ribs 70 extending along a length of the drive shaft 62.
  • the rotation of the thrusting pin 52 along the thrusting groove 54 causes the inner sleeve 24 to oscillate longitudinally providing a needle with back and forth axial motion.
  • the battery 30 may be provided to supply power to the motor 60. In other embodiments, an external power source may be used.
  • the biopsy device 10 includes the switch 28 (e.g., a micro switch) that can be used to activate the motor assembly 26.
  • the switch 28 can be used to close or open a circuit between the battery 30 and the motor 60 in order to provide power and activate the motor 60.
  • the switch 28 may be actuated to provide a signal to a controller, which can then control operation of the motor 60.
  • the lever 32 may include an actuation pin 72 that can be used to actuate the switch 28 with the lever 32 in an aspiration position, as shown in FIG. 1.
  • FIG. 1 shows the biopsy device 10 including lever 32 actuated in the aspiration position
  • FIG. 5 shows the biopsy device 10 including lever 32 in an initial, release position.
  • the lever 32 With the biopsy device 10 in the release position, the lever 32 can be pressed, which causes the first and second articulation portions 34 and 36 to pivot relative to each other at the pivot location 38, thereby elongating the distance between the pivot mounts 40 and 42 and sliding the inner housing 14 out of the outer housing 12.
  • the motor assembly 26 including the motor 60 and the drive shaft 62, and the battery 30 move with the inner housing 14 relative to the outer housing 12.
  • a distal end of the drive shaft 62 includes a seal 76 that forms an air tight seal against an inner surface 78 of the barrel 50.
  • Movement of the drive shaft 62 proximally increases the chamber volume within the barrel 50, which reduces the pressure inside the vacuum chamber 51.
  • the reduced pressure can be transmitted through the hollow needle connected to the needle connector 48 for aspiration.
  • placing the lever 32 in the actuation position can also actuate the switch 28 using the actuation pin 72.
  • the switch may be placed elsewhere on the biopsy device 10 and be manually actuated separately from the lever 32 operation. Actuating the switch 28 activates the motor 60, which rotates the drive shaft 62.
  • Rotating the drive shaft 62 rotates the inner sleeve 24 and causes axial oscillation of the inner sleeve 24 relative to the outer housing 12 using the thrusting pin 52 and thrusting groove 54.
  • Placing the lever 32 in the initial, release position shown by FIG. 5, moves the drive shaft 62 and the seal 76 toward the needle connector 48, which releases the negative pressure in the vacuum chamber 51 and deactivates the motor 60.
  • another actuation mechanism for generating the negative pressure may be a moveable button 80.
  • the moveable button 80 may be moved proximally to create the vacuum in the vacuum chamber, such as vacuum chamber 51.
  • a preloaded spring 82 may be released using, for example, button 84 in order to move drive shaft 85 proximally to create the vacuum in vacuum chamber 86.
  • the biopsy device 81 includes outer housing 90 that includes the first button 84 and a second button 92 that is proximal of the first button 84.
  • a motor housing 94 includes a hook 96 that is cantilevered and is resiliently bendable to release the hook 96 and motor housing 94 from a first notch 98 formed in the outer housing 90 when the first button 84 is depressed. Releasing the hook 96 from the first notch 98 allows the spring 82 to expand and move the motor housing 94 proximally, which also causes a drive shaft 100 to move proximally in order to generate negative pressure inside barrel 102.
  • FIGS. 8-10 Operation of the biopsy device 81 is shown by FIGS. 8-10.
  • the biopsy device 81 is shown in an initial configuration with spring 82 being compressed to a preloaded position by pushing the motor housing 94 distally within the outer housing 90 until the hook 96 catches the first notch 98.
  • the biopsy device 81 may be considered in a loaded status and ready to initiate a biopsy procedure.
  • the hook 96 is released from the first notch 98 and the motor housing 94 translates proximally under power from the spring 82 until the hook 96 reaches a second notch 104 that is proximal of the first notch 98 shown by FIG. 9.
  • FIG. 9 may be considered a vacuum applied status for the biopsy device 81.
  • depressing the second button 92 releases the hook 96 from the second notch 104 and the motor housing 94 translates proximally under power from the spring 82 until the hook 96 reaches a third notch 112 that is proximal of the second notch 104.
  • FIG. 10 may be considered a vacuum released status for the biopsy device 81.
  • the motor 106 and motor housing 94 may be pushed distally relative to the outer housing 90 until the hook 96 catches the first notch 98 shown by FIG. 8 and the process may be repeated.
  • any other suitable mechanism may be used to move the drive shaft and create the vacuum in the vacuum chamber. Further, other mechanisms may be used to create the oscillating motion of the inner sleeve, such as a rotating cam or a solenoid. In some embodiments, the drive shaft may be rotated using a manually-actuated mechanism, such as a drive handle or crank.
  • the above-described biopsy devices are semi-automated with electric power-driven equipment providing functions to improve sampling efficiency and quality.
  • the biopsy devices can apply a suction during FNAB, rotate the needle during the FNAB, while also thrusting the needle during the FNAB.
  • the biopsy devices may be disposable or reusable assemblies for cost- efficiency and infection control purposes.
  • the biopsy devices may be constructed to be compact and handled similarly to a marker pen. The biopsy devices can be held in place and the vacuum, thrusting and rotation can be automatically applied. The user of the biopsy devices simply needs to hold the biopsy devices in place and adjust the needle tip direction to collect samples in different locations.
  • a fine needle biopsy device comprising: an outer housing having a distal end; a needle connector that is connected to the distal end of the outer housing, the needle connector configured to connect to a needle; a vacuum chamber carried by the outer housing and fluidly connected to the needle connector; an inner housing slidably received within an opening through the outer housing; and a motor carried by the inner housing, the motor operably connected to the needle connector by a drive shaft that extends into the vacuum chamber; wherein the inner housing moves axially relative to the outer housing to move the drive shaft between a release position and an aspiration position.
  • Clause 2 The fine needle biopsy device of clause 1 further comprising a seal connected to an end of the drive shaft and located in the vacuum chamber, the seal sealingly engaged with an inner surface of a sidewall of the vacuum chamber.
  • Clause 3 The fine needle biopsy device of clause 1 or 2 further comprising an inner sleeve that is located within the outer housing, the vacuum chamber located within the inner sleeve.
  • Clause 4 The fine needle biopsy device of clause 3 further comprising a sleeve cover that partially covers a proximal end of the inner sleeve, the sleeve cover having a slot through which the drive shaft extends.
  • Clause 5 The fine needle biopsy device of clause 4, wherein the drive shaft has a noncircular cross-section, the slot having a corresponding non-circular cross-section that is configured to mate with the non-circular cross-section of the drive shaft such that the sleeve cover rotates with the drive shaft when the motor is activated.
  • Clause 6 The fine needle biopsy device of claim 3, wherein the inner sleeve and the outer housing are operably connected together by a cam and follower arrangement such that rotation of the inner sleeve relative to the outer housing results in reciprocal axial movement of the inner sleeve relative to the outer housing.
  • Clause 7 The fine needle biopsy device of any of clauses 1-6, further comprising an actuator that is connected to the outer housing and the inner housing, the actuator being moveable from an initial configuration where the inner housing is in the release position relative to the outer housing to an actuated position where the inner housing is in the aspiration position relative to the outer housing.
  • Clause 8 The fine needle biopsy device of clause 7, wherein the actuator comprises a lever comprising a first end connected to the outer housing and a second end connected to the inner housing.
  • Clause 9 The fine needle biopsy device of clause 8, wherein the inner housing moves telescopically into and out of a proximal end of the outer housing as the inner housing moves axially relative to the outer housing between the release position and the aspiration position.
  • Clause 10 The fine needle biopsy device of any of clauses 1-9, wherein the drive shaft is in-line with the motor.
  • a fine needle biopsy device comprising: a first housing portion and a second housing portion, wherein the first and second housing portions are telescopically connected together such that the second housing portion moves axially relative to the first housing portion between a release position and an aspiration position; a needle connector that is connected to a distal end of the first housing portion, the needle connector configured to connect to a needle; a vacuum chamber carried by the first housing portion and fluidly connected to the needle connector; and a motor that moves with the second housing portion between the release position and the aspiration position, the motor operably connected to the needle connector by a drive shaft that extends into the vacuum chamber.
  • Clause 12 The fine needle biopsy device of clause 11 further comprising a seal connected to an end of the drive shaft and located in the vacuum chamber, the seal sealingly engaged with an inner surface of a sidewall of the vacuum chamber.
  • Clause 13 The fine needle biopsy device of clause 11 or 12 further comprising an inner sleeve that is located within the outer housing, the vacuum chamber located within the inner sleeve.
  • Clause 14 The fine needle biopsy device of clause 13 further comprising a sleeve cover that partially covers a proximal end of the inner sleeve, the sleeve cover having a slot through which the drive shaft extends.
  • Clause 15 The fine needle biopsy device of clause 14, wherein the drive shaft has a non-circular cross-section, the slot having a corresponding non-circular cross-section that is configured to mate with the non-circular cross-section of the drive shaft such that the sleeve cover rotates with the drive shaft when the motor is activated.
  • Clause 16 The fine needle biopsy device of any of clauses 13-15, wherein the inner sleeve and the outer housing are operably connected together by a cam and follower arrangement such that rotation of the inner sleeve relative to the outer housing results in reciprocal axial movement of the inner sleeve relative to the outer housing.
  • Clause 17 The fine needle biopsy device of any of clauses 11-16, further comprising an actuator that is connected to the outer housing and the inner housing, the actuator being moveable from an initial configuration where the inner housing is in the release position relative to the outer housing to an actuated position where the inner housing is in the aspiration position relative to the outer housing.
  • Clause 18 The fine needle biopsy device of clause 17, wherein the actuator comprises a lever comprising a first end connected to the outer housing and a second end connected to the inner housing.
  • Clause 19 The fine needle biopsy device of clause 18, wherein the inner housing moves telescopically into and out of a proximal end of the outer housing as the inner housing moves axially relative to the outer housing between the release position and the aspiration position.
  • Clause 20 The fine needle biopsy device of any of clauses 11-19, wherein the drive shaft is in-line with the motor.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif de biopsie à aiguille fine comprend un boîtier externe ayant une extrémité distale et un raccord d'aiguille qui est relié à l'extrémité distale du boîtier externe. Le raccord d'aiguille est conçu pour être relié à une aiguille. Une chambre à vide est portée par le boîtier externe et est en communication fluidique avec le raccord d'aiguille. Un boîtier interne est reçu de manière coulissante à l'intérieur d'une ouverture à travers le boîtier externe. Un moteur est porté par le boîtier interne. Le moteur est relié de manière fonctionnelle au raccord d'aiguille par un arbre d'entraînement qui s'étend dans la chambre à vide. Le boîtier interne se déplace axialement par rapport au boîtier externe pour déplacer l'arbre d'entraînement entre une position de libération et une position d'aspiration.
PCT/US2024/027581 2024-05-03 2024-05-03 Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine Pending WO2025230535A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2024/027581 WO2025230535A1 (fr) 2024-05-03 2024-05-03 Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2024/027581 WO2025230535A1 (fr) 2024-05-03 2024-05-03 Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine

Publications (1)

Publication Number Publication Date
WO2025230535A1 true WO2025230535A1 (fr) 2025-11-06

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/027581 Pending WO2025230535A1 (fr) 2024-05-03 2024-05-03 Dispositifs de biopsie pour biopsie par aspiration à l'aiguille fine

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Country Link
WO (1) WO2025230535A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4989614A (en) * 1988-02-23 1991-02-05 Vance Products Incorporated Fine-needle aspiration cell sampling methods
KR101524501B1 (ko) * 2013-11-25 2015-06-01 김동주 세침검사용 주사기 제어장치
US20220096065A1 (en) * 2018-09-28 2022-03-31 Praxis Holding Llc Oscillating syringe system and needle
CN116473640A (zh) * 2023-05-05 2023-07-25 南昌大学第一附属医院 一种胸部肿瘤穿刺装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4989614A (en) * 1988-02-23 1991-02-05 Vance Products Incorporated Fine-needle aspiration cell sampling methods
KR101524501B1 (ko) * 2013-11-25 2015-06-01 김동주 세침검사용 주사기 제어장치
US20220096065A1 (en) * 2018-09-28 2022-03-31 Praxis Holding Llc Oscillating syringe system and needle
CN116473640A (zh) * 2023-05-05 2023-07-25 南昌大学第一附属医院 一种胸部肿瘤穿刺装置

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