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WO2018058093A1 - Poignée d'aiguille à rétraction de ressort - Google Patents

Poignée d'aiguille à rétraction de ressort Download PDF

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Publication number
WO2018058093A1
WO2018058093A1 PCT/US2017/053400 US2017053400W WO2018058093A1 WO 2018058093 A1 WO2018058093 A1 WO 2018058093A1 US 2017053400 W US2017053400 W US 2017053400W WO 2018058093 A1 WO2018058093 A1 WO 2018058093A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
force
proximal
distal
distal end
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/US2017/053400
Other languages
English (en)
Inventor
Madeline GRAHAM
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.)
Spiration Inc
Original Assignee
Spiration 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 Spiration Inc filed Critical Spiration Inc
Publication of WO2018058093A1 publication Critical patent/WO2018058093A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • 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
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A61B2010/045—Needles

Definitions

  • the present invention relates to needle aspiration devices used for tissue sampling.
  • Needle aspiration devices such as transbronchial needle aspiration (TBNA) devices, are used to collect samples from target tissue, such as tumors and nodules, for analysis.
  • TBNA transbronchial needle aspiration
  • Some needle aspiration handle designs use simple cantilever springs, friction fits or O-rings. Typically, these devices require manual retraction and activation.
  • the present invention provides a safety mechanism for doctors by partially or fully retracting a needle upon release of a needle actuator.
  • the handle body includes a spring or comparable mechanism that applies a proximal force to the needle actuator. Upon activating the needle, resistance is felt due to the spring. By releasing the actuator, the spring returns to its expanded state, which returns the needle to its retracted, or a partially retracted position.
  • FIGURE 1-1 illustrates a side view of an aspiration device in a deactivated state in accordance with principles of the present invention
  • FIGURE 1-2 illustrates a side view of the aspiration device of FIGURE 1- 1 in an activated state in accordance with principles of the present invention
  • FIGURE 2 illustrates a cross-sectional view of the aspiration device of FIGURE 1-1 ;
  • FIGURE 3-1 illustrates a side view of the needle of FIGURE 2 within the handle body in a non-activated state
  • FIGURE 3-2 illustrates an x-ray view of the distal end of the aspiration device of FIGURE 3-1 when in the non-activated state
  • FIGURE 4-1 illustrates a side view of the needle of FIGURE 2 within the handle body in an activated state
  • FIGURE 4-2 illustrates a side view of the distal end of aspiration device of FIGURE 4-1 when in the activated state
  • FIGURES 5-7 illustrate an embodiment for attaching a guide sheath to an aspiration device
  • FIGURE 8 illustrates an embodiment for attaching a guide sheath to an aspiration device
  • FIGURE 9 illustrates an embodiment for attaching a guide sheath to an aspiration device
  • FIGURE 10 illustrates an embodiment for attaching a guide sheath to an aspiration device
  • FIGURE 11 illustrates an embodiment for attaching a guide sheath to an aspiration device.
  • FIGURE 1-1 illustrates an example needle aspiration device 20 (e.g., trans bronchial needle aspiration (TBNA) device) in a deactivated position and FIGURE 1-2 illustrates the device 20 in an activated position.
  • the device 20 includes a handle body 26, a needle actuator 28, a stylet knob 30 and a Luer component 32.
  • the handle body 26 is attached to a proximal end of a sheath 34.
  • the needle actuator 28 includes a shaft portion 36 coupled to a handle portion 38.
  • the needle actuator 28 receives and is attached to a proximal end of a needle 40.
  • the stylet knob 30 is attached to a proximal end of a stylet (not shown).
  • the stylet knob 30 rotatably attaches to a proximal end of the Luer component 32.
  • a distal end of the Luer component 32 is attached to a cavity of the handle portion 38 of the needle actuator 28.
  • the shaft portion 36 is slidably received within a cavity (i.e., lumen) of the handle body 26. Interactive operation of the parts of the device 20 are described in more detail below.
  • the shaft portion 36 of the needle actuator 28 has an outside diameter that is approximately the same as the inside diameter of the cavity of the handle body 26.
  • the shaft portion 36 is inserted into the cavity of the handle body 26 and may be kept from extraction using a set screw (not shown) in the handle body 26.
  • the shaft portion 36 includes a slot (not shown) that receives the set screw and may also include a separate groove for receiving the set screw to lock the needle actuator 28 in an activated state.
  • the cavity of the handle body 26 has a tapered section 56 located between a main portion and an exit lumen.
  • a spring 50 is received within the cavity of the handle body 26 such that compression of the spring 50 occurs along a longitudinal axis of the handle body 26.
  • the spring 50 is located at the distal end of the cavity of the handle body 26 for receiving the needle 40 that is attached to the needle actuator 28.
  • the needle 40 is received within the shaft portion 36.
  • a tapered distal end 44 of the shaft portion 36 makes contact with the proximal end of the spring 50 during compression.
  • FIGURE 3-1 the spring 50 is in a fully extended configuration.
  • the needle 40 In the fully extended configuration, the needle 40 is in a deactivated state or a partially retracted state.
  • FIGURE 3-2 illustrates the deactivation state of the needle aspiration device 20, whereby the distal end of the needle 40 is fully housed within the sheath 34.
  • FIGURES 4-1 and 4-2 illustrate the needle aspiration device 20 in a fully or partially activated state.
  • the shaft portion 36 has a distal force applied to it, which causes the shaft portion 36 to make contact with a proximal end of the spring 50 thus forcing a distal end of the spring 50 to come into contact with the tapered section 56 of the cavity and compressing the spring 50.
  • a user initiates needle activation by applying a distal force on the handle portion 38 of the needle actuator 28.
  • the spring 50 returns to either its configuration prior to compression or goes to a partially retracted position. In the partially retracted position, the distal end of the needle 40 stops somewhere between the fully extended position and the fully retracted position. In one embodiment, the needle 40 does not fully exit the target tissue as the operator (i.e., doctor) repeatedly compresses the needle actuator 28 and the spring 50 for performing tissue agitations.
  • FIGS 5-7 show examples of ways to connect a guide sheath to a needle sheath and/or needle handle.
  • a screw top is connected to the sheath of a needle aspiration device.
  • the top of a guide sheath includes threads.
  • the guide sheath and needle aspiration device could be locked together when the screw top receives the top of the guide sheath.
  • the location of the screw top determines how far the needle sheath/device will extend out of the guide sheath.
  • the handle of the needle aspiration device instead of having a separate screw top attached to the needle sheath, the handle of the needle aspiration device includes a Luer fitting at its distal end that mates with the threaded proximal end of the guide sheath.
  • FIGURE 9 shows a hemostasis valve that prevents backflow of liquid.
  • the hemostasis valve attaches to a guide sheath by locking the Luer fitting of the hemostasis valve to the guide sheath and then inserting the needle through the hemostasis valve and the guide sheath.
  • the hemostasis valve has a twist top that can tighten around the needle sheath to hold it relative to the guide sheath.
  • the added benefit of this attachment is that the rigid middle portion of the hemostasis valve provides structural support for long, flexible needles. Also, the amount that the needle sheath extends past the guide sheath can easily be changed by loosening and retightening the hemostasis valve.
  • FIGURES 10 and 11 illustrate other ways guide sheaths may be attached to a needle sheath or a needle handle.
  • a collet device attaches to the needle and/or the needle sheath.
  • a proximal end of the guide sheath includes a device with a lock slot for receiving and locking to a distal end of the collet device.
  • a screw top is held in place by guide sheath stoppers. This allows for the screw top to be repositioned along the length of the needle sheath thus changing the amount that the needle extends past of the guide sheath.
  • the screw top receives a proximal end of the guide sheath.

Landscapes

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

Abstract

L'invention porte sur un instrument médical ayant une aiguille d'aspiration et un mécanisme de rétraction de poignée. Le dispositif de poignée commande la force nécessaire à un utilisateur pour activer l'aiguille et fournit une force plus élevée pour initier l'activation et une contre-force pour auto-rétracter l'aiguille.
PCT/US2017/053400 2016-09-26 2017-09-26 Poignée d'aiguille à rétraction de ressort Ceased WO2018058093A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662399814P 2016-09-26 2016-09-26
US62/399,814 2016-09-26

Publications (1)

Publication Number Publication Date
WO2018058093A1 true WO2018058093A1 (fr) 2018-03-29

Family

ID=61689768

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/053400 Ceased WO2018058093A1 (fr) 2016-09-26 2017-09-26 Poignée d'aiguille à rétraction de ressort

Country Status (1)

Country Link
WO (1) WO2018058093A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5685856A (en) * 1996-02-27 1997-11-11 Lehrer; Theodor Coaxial blunt dilator and endoscopic cannula insertion system
US20050090763A1 (en) * 2003-10-27 2005-04-28 Ko-Pen Wang Transendoscopic double needle assembly
US20160136359A1 (en) * 2012-03-14 2016-05-19 Becton, Dickinson And Company Retracting Sheath Detachable Safety Needle with Moving Spring

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5685856A (en) * 1996-02-27 1997-11-11 Lehrer; Theodor Coaxial blunt dilator and endoscopic cannula insertion system
US20050090763A1 (en) * 2003-10-27 2005-04-28 Ko-Pen Wang Transendoscopic double needle assembly
US20160136359A1 (en) * 2012-03-14 2016-05-19 Becton, Dickinson And Company Retracting Sheath Detachable Safety Needle with Moving Spring

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