WO2023183630A1 - Dispositifs à aiguille stabilisant l'accès à un tissu, systèmes et procédés - Google Patents

Dispositifs à aiguille stabilisant l'accès à un tissu, systèmes et procédés Download PDF

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Publication number
WO2023183630A1
WO2023183630A1 PCT/US2023/016327 US2023016327W WO2023183630A1 WO 2023183630 A1 WO2023183630 A1 WO 2023183630A1 US 2023016327 W US2023016327 W US 2023016327W WO 2023183630 A1 WO2023183630 A1 WO 2023183630A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
distal end
stabilizing member
lumen
port
Prior art date
Application number
PCT/US2023/016327
Other languages
English (en)
Inventor
Ghassan S. Kassab
Gregory Kelley
Neil Drake
Original Assignee
Sureax, 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 Sureax, Inc. filed Critical Sureax, Inc.
Publication of WO2023183630A1 publication Critical patent/WO2023183630A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • 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
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • 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
    • A61M25/065—Guide needles

Definitions

  • IL intranodal lymphangiography
  • USG ultrasound guidance
  • a contrast material is then slowly injected into the lymph node, and the lymphatic system is then imaged.
  • IL procedure such as positioning of the needle precisely in the central part of the lymph node and securing the needle there during the procedure or patient transfer leading to frequent dislodgement of the needle, and greatly impairing the quality of the imaging and success of the procedure.
  • Another area where optimal position and stability of the needle is neurological/spinal procedures.
  • a doctor uses a needle to place stimulating electrodes at the base of the skull with leads connected to a power source (pulse generator) that sends electrical impulses to the occipital nerve. If the needle is advanced too deep, or if the needle is easily dislodged and moves around, it can injure the brain stem.
  • a power source pulse generator
  • PICC peripherally inserted central catheter
  • CAR T cell chimeric antigen receptor T cell
  • the present disclosure includes disclosure of a needle device, comprising a needle having a needle lumen defined therethrough terminating at a needle aperture at or near a distal end of the needle, the needle device configured to engage a tissue and further configured to introduce a fluid through the needle lumen into the tissue or a lumen thereof.
  • the present disclosure includes disclosure of a needle device, further comprising a stabilizing wire positioned within the needle lumen, the stabilizing wire configured to at least partially protrude from the needle aperture and to engage a tissue.
  • the stabilizing wire comprises a helical portion with a sharp tip, and wherein the helical portion is configured to engage a tissue.
  • the present disclosure includes disclosure of a needle device, further comprising a hub configured to deploy the stabilizing wire from the needle aperture and to retract the stabilizing wire into the needle aperture.
  • the present disclosure includes disclosure of a needle device, wherein the hub comprises a slide mechanism operably connected to the stabilizing wire to propel the stabilizing wire into the tissue.
  • the present disclosure includes disclosure of a needle device, wherein the slide mechanism is configured to be manually triggered.
  • the present disclosure includes disclosure of a needle device, wherein the stabilizing wire comprises a helical distal end terminating with a sharp and distal tip.
  • the present disclosure includes disclosure of a needle device, comprising multiple lumens defined therethrough terminating at a needle aperture at or near a distal end of the needle, and a stabilizing wire positioned within a first of the multiple lumens, wherein the stabilizing wire comprises a helical portion, and wherein the helical portion is configured to at least partially protrude from the needle aperture and to reversibly engage a tissue, the needle device configured to reversibly puncture a tissue and further configured to introduce a fluid through a second of the multiple lumens into the tissue or a lumen thereof.
  • the present disclosure includes disclosure of a needle device, comprising a lumen defined therethrough terminating at a needle aperture at or near a distal end of the needle, and multiple stabilizing wires positioned within the lumen, wherein the stabilizing wires each comprise a helical portion, and wherein the helical portion is configured to at least partially protrude from the needle aperture and to reversibly engage a tissue, the needle device configured to reversibly puncture a tissue and further configured to introduce a fluid through the lumen into the tissue or a lumen thereof.
  • the present disclosure includes disclosure of a method for using a needle device to access tissue at a desired location within a patient’s body, the method comprising the steps of inserting a needle into the tissue of a patient, wherein the needle comprises a lumen and a needle aperture; deploying a stabilizing wire to attach the needle device to the tissue; introducing fluid into the tissue; retracting the stabilizing wire; and removing the needle.
  • the present disclosure includes disclosure of a method, wherein the step of introducing fluid comprises the step of introducing fluid through an injection port in a hub having an extension member thereon.
  • FIG. 1 shows a device for stabilized accessing of tissue at a desired location within a patient’ s body including a needle with stabilizing wire and a hub with an extension set, according to an embodiment of the present disclosure
  • FIG. 2 shows a device for stabilized accessing of tissue at a desired location within a patient’ s body including a needle with stabilizing wire and a hub with an extension set, according to an embodiment of the present disclosure
  • FIG. 3 shows a needle according to an embodiment of the present disclosure
  • FIG. 4A shows a stabilizing wire to be used with a needle according to an embodiment of the present disclosure
  • FIG. 4B shows a stabilizing wire to be used with a needle according to an embodiment of the present disclosure
  • FIG. 4C shows a stabilizing wire to be used with a needle according to an embodiment of the present disclosure
  • FIG. 5 shows a needle device accessing tissue at a desired location within a patient’s body with the stabilizing wire deployed to secure the needle according to an embodiment of the present disclosure
  • FIG. 6 shows a needle device accessing tissue at a desired location within a patient’s body with the stabilizing wire retracted according to an embodiment of the present disclosure
  • FIG. 7 shows a hidden, dashed-line view of a multi-lumen needle device accessing tissue at a desired location within a patient’ s body with the stabilizing wire deployed proximal of the tissue at the desired location, according to an embodiment of the present disclosure
  • FIG. 8 shows a sectional view of a multi-lumen needle device accessing tissue at a desired location within a patient’ s body with the stabilizing wire deployed proximal of the tissue at the desired location, according to an embodiment of the present disclosure
  • FIG. 9 shows a hidden, dashed-line view of a multi-lumen needle device accessing tissue at a desired location within a patient’s body with the stabilizing wire deployed distal of the tissue at the desired location, according to an embodiment of the present disclosure
  • FIG. 10 shows a needle device with multiple stabilizing wires deployed, according to an embodiment of the present disclosure.
  • distal is used to refer to the part of the device farthest from an operator or closest to a patient.
  • proximal is used to describe the part of the device closest to an operator or farthest from a patient.
  • the part of the needle that is inserted into the patient first will be the distal part.
  • the present invention is suitable for use in accessing a target site within a body.
  • a target site can be located in any anatomic location in the body.
  • a site is identified by the physician or radiologist and the tissue, cells and/or fluid, or other material at that site, is then identified as target material and selected or targeted for access.
  • the target tissue, cells or fluid can be the target material identified for access from: lymph, brain, heart, liver, kidney, thyroid, lung, pancreas, intestine, uterine, ovary, prostate, spleen, skin, biliary, parathyroid, pituitary, adrenal gland, mediastinum, bladder, connective tissue, breast, gastrointestinal tract, joints, muscle, etc.
  • the target site may include fluid, or other material which is the target for access.
  • target material e.g. tissue, cells and/or fluid
  • one or more diagnostic, therapeutic or delivery procedures can be employed to remove, treat and/or mark the target material.
  • An application of the device includes intranodal lymphangiogram during which the distal end of a needle is positioned inside a lymph node under ultrasound guidance and contrast is slowly injected through the needle into the lymph node, wherein the needle tip is secured to the lymph node to prevent dislodgment of the needle from the lymph node to ensure no contrast is injected outside of the lymph node.
  • a needle device 10 of the present invention shown in FIGS. 1-2 comprises a needle 12, a stabilizing wire 50, and a hub 60.
  • the needle 12 comprises a distal end 14 comprising an open distal tip 18, a proximal end 16, and a sidewall 24 defining a needle lumen 28.
  • the open distal tip 18 of needle 12 is sharp to aid in puncturing tissue.
  • the open distal tip 18 may also be configured to be echogenic.
  • the hub 60 includes a needle port 62, an injection port 64 with extension set 66, a stabilizer port 68, and a seal 70.
  • the proximal end 16 of needle 12 is connected to the needle port 62 of the hub 60.
  • the needle device 10 is configured to allow fluid communication between the injection port 64 and the needle port 62 and the needle lumen via the proximal end 16 of the needle 12 positioned within the needle port 62.
  • contrast media can be introduced into the injection port 64 via a syringe or other method connected to the extension set 66, and then travel to the needle port 62, into the open proximal end 16 of the needle 12, and then through the needle lumen 28 to exit the needle 12 at the open distal tip 18.
  • the stabilizing wire 50 comprises a proximal end 52 and a distal end 54.
  • the distal end 54 comprises a helical portion 56 with a sharp tip 58.
  • the stabilizing wire 50 is slidingly disposed within the needle lumen 28, the proximal end 52 being positioned within the stabilizer port 68 of the needle hub 60.
  • the stabilizing wire 50 is operably connected to a slide trigger 69 on the hub 60.
  • the slide trigger 69 is configured such that it can be moved longitudinally on an exterior surface of the hub 60, thereby causing the stabilizing wire 50 to slide longitudinally within the stabilizer port 68 of hub 60.
  • the slide trigger 69 is configured to slide a sufficient distance back and forth along a longitudinal axis of the hub 60 such that it causes the helical portion 56 of the stabilizer wire 50 to slide between a retracted position and a deployed position. For example, when the slide trigger 69 is moved to pull the stabilizing wire 50 to a proximal position within the stabilizer port 68 of the needle hub 60, the stabilizing wire 50 is pulled into a retracted position wherein the helical portion 56 is pulled into the needle lumen and whereby the helical portion 56 is substantially straightened and constrained within the needle lumen 28.
  • the slide trigger 69 When the slide trigger 69 is moved to push the stabilizing wire 50 to a distal position within the stabilizer port 68 of the needle hub 60, the sharp tip 58 at the end of the helical portion 56 of the stabilizing wire 50 is pushed out through the open distal tip 18 of the needle 12 and deployed into surrounding tissue.
  • the stabilizing wire 50 may be made from a material with relatively high elastic deformation, such as nitinol or similar materials, such that the helical portion 56 of the stabilizing wire 50 can recover its shape as it is being deployed from the distal tip 18 of the needle 12 after being substantially straightened while retracted into the needle lumen 28.
  • the stabilizer wire may be made from round or flat wire. Thinner flat wire allows the helical portion 56 to be formed to a smaller radius and still recover its helical shape after being substantially straightened within the needle lumen 28.
  • the helical portion 56 recovers its helical shape, and the sharp tip 58 advances along the path of the helix and penetrates surrounding body tissue near the distal tip 18 of the needle 12 thereby securing the needle 12 to the tissue.
  • the shape of the helical portion 56 reduces penetration resistance, and also helps the stabilizing wire 50 to pull itself out of the needle lumen 28, and the sharp tip 58 makes for easier penetration and also enhances inward deflection.
  • the length of the helical portion 56 of stabilizing wire 50 depends upon the requirements of the particular application for which the needle device 10 is being used.
  • the constituent elements can be interchanged to produce a device for particular use in accessing and securing to lymph nodes. Some of the interchangeability is discussed further below.
  • FIGS. 7-9 show an embodiment of a needle device 10 wherein the needle 12 comprises multiple lumen 28, 29, and the stabilizing wire 50 may be slidably disposed in either lumen 28 or 29, and injection of a contrast media, or other type of agent, can be delivered through the other of lumen 28 or 29.
  • needle 12 is configured such that stabilizing wire 50 is deployed through lumen 29 at a point proximal to the target tissue and lumen 28 is positioned in the target tissue whereby a therapeutic agent is delivered through lumen 28 to the target tissue.
  • needle 12 is configured such that stabilizing wire 50 is deployed through lumen 28 at a point distal to the target tissue and lumen 29 is positioned in the target tissue whereby a therapeutic agent is delivered through lumen 29 to the target tissue.
  • FIG. 10 shows an embodiment in which multiple stabilizing wires 50, 150 are disposed in lumen 28 of needle 12.
  • a curved needle can be used with the invention of the present disclosure.
  • a user places the needle 12 into the tissue at the desired location within a patient’s body.
  • the physician slides the trigger 69 on the hub 60 to deploy the stabilizing wire 50.
  • the stabilizing wire 50 exits the needle lumen 28, the helical portion 56 of the stabilizing wire 50 recovers its helical shape, and the sharp tip 58 advances along the path of the helix and penetrates surrounding body tissue near the distal tip 18 of the needle 12 thereby securing the needle 12 to the tissue.
  • the stabilizing wire 50 stabilizes the needle 12 against both push and pull forces.
  • the physician can inject fluid, such as contrast media, into the injection port 64 of the hub 60 through the extension element 66, which comprises a flexible tube 70 connected to the injection port 64 at a distal end 72, and having a proximal end 74 configured to engage with a syringe or other delivery source as is known in the art.
  • the fluid will then travel into the needle port 62 of the hub 60 and into and through the needle lumen 28 and out the open distal tip 18 of the needle 12 into the tissue.
  • the physician slides the trigger 69 to retract the stabilizing wire 50 and can remove the needle 12 from the patient.
  • the present disclosure may have presented a method and/or a process as a particular sequence of steps.
  • the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure.
  • disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.

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

Abstract

Sont décrits, des dispositifs à aiguille permettant d'accéder au tissu à un emplacement souhaité à l'intérieur du corps d'un patient afin d'administrer des agents biologiques, chimiques ou d'autres agents thérapeutiques au tissu, ou d'obtenir un échantillon du tissu, ou d'obtenir un échantillon de fluide corporel ou de drainer autrement un fluide corporel du corps d'un patient, et fixés après l'accès au nœud tissulaire. Le dispositif à aiguille comprend un moyeu, une aiguille et un fil de stabilisation. La fixation de l'aiguille peut être réalisée par l'intermédiaire d'un fil de stabilisation présentant une partie de mise en prise de tissu hélicoïdale, qui peut être introduite par l'intermédiaire d'une pointe d'aiguille ouverte ou d'une ouverture de lumière. Le fil de stabilisation peut être fixé à un déclencheur coulissant sur le moyeu. Un fluide peut être introduit dans le dispositif à aiguille par l'intermédiaire d'un orifice d'injection dans le moyeu avec un élément d'extension sur ce dernier.
PCT/US2023/016327 2022-03-24 2023-03-24 Dispositifs à aiguille stabilisant l'accès à un tissu, systèmes et procédés WO2023183630A1 (fr)

Applications Claiming Priority (2)

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US202263323490P 2022-03-24 2022-03-24
US63/323,490 2022-03-24

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WO2023183630A1 true WO2023183630A1 (fr) 2023-09-28

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5018530A (en) * 1989-06-15 1991-05-28 Research Corporation Technologies, Inc. Helical-tipped lesion localization needle device and method of using the same
US20120143226A1 (en) * 2009-03-14 2012-06-07 Vasostitch, Inc. Vessel access and closure device
WO2018129127A1 (fr) * 2017-01-06 2018-07-12 The Trustees Of The University Of Pennsylvania Aiguille d'accès à un ganglion lymphatique
WO2021151101A1 (fr) * 2020-01-23 2021-07-29 Kassab Ghassan S Dispositifs à aiguille pour accéder à des ganglions lymphatiques et à des conduits thoraciques
US20220080158A1 (en) * 2020-09-15 2022-03-17 Becton, Dickinson And Company Method of Thrombus Removal and Related Devices and Systems

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5018530A (en) * 1989-06-15 1991-05-28 Research Corporation Technologies, Inc. Helical-tipped lesion localization needle device and method of using the same
US20120143226A1 (en) * 2009-03-14 2012-06-07 Vasostitch, Inc. Vessel access and closure device
WO2018129127A1 (fr) * 2017-01-06 2018-07-12 The Trustees Of The University Of Pennsylvania Aiguille d'accès à un ganglion lymphatique
WO2021151101A1 (fr) * 2020-01-23 2021-07-29 Kassab Ghassan S Dispositifs à aiguille pour accéder à des ganglions lymphatiques et à des conduits thoraciques
US20220080158A1 (en) * 2020-09-15 2022-03-17 Becton, Dickinson And Company Method of Thrombus Removal and Related Devices and Systems

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