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WO2025032437A1 - Instrument d'injection intratumorale à aiguilles multiples - Google Patents

Instrument d'injection intratumorale à aiguilles multiples Download PDF

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Publication number
WO2025032437A1
WO2025032437A1 PCT/IB2024/057459 IB2024057459W WO2025032437A1 WO 2025032437 A1 WO2025032437 A1 WO 2025032437A1 IB 2024057459 W IB2024057459 W IB 2024057459W WO 2025032437 A1 WO2025032437 A1 WO 2025032437A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
tines
deflector
sleeve
injection instrument
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/IB2024/057459
Other languages
English (en)
Inventor
Jennifer S. MATTINGLEY
Scott E. M. Frushour
Daniel A. LEDEEN
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.)
Covidien LP
Original Assignee
Covidien LP
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
Priority claimed from US18/740,737 external-priority patent/US20250050066A1/en
Application filed by Covidien LP filed Critical Covidien LP
Publication of WO2025032437A1 publication Critical patent/WO2025032437A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61B17/3478—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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0085—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
    • A61M2025/0086—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel

Definitions

  • This disclosure is generally related to surgical instruments and, more particularly, to surgical instruments including a plurality of injection needles for intratumoral injections.
  • Intratumoral injection includes accessing a tumor and injecting therapeutic agents with the idea of compartmentalizing the agent to a localized region to avoid systemic side effects that have historically been associated with chemotherapy and other treatment modalities.
  • the disease may present homogeneous across the mass. However, in some tumors and particularly in the lung, the disease presents in a more heterogenous condition. This means that within a lung nodule, you may find both diseased and healthy cells. Because of this phenomena, it is advisable to sample tissue from various places within the nodule to affirm the nodule is indeed malignant.
  • a surgical intratumoral injection instrument includes a supply chamber, a handle assembly, a sleeve extending from the handle assembly, a distal ring, a plurality of needle tines, and a deflector.
  • the plurality of needle tines extends through a lumen of the sleeve, is movable through the lumen of the sleeve via the handle assembly, and is configured to dispense a therapeutic agent from the supply chamber.
  • the deflector extends through the lumen and is movable through the lumen via the handle assembly. Retraction of the deflector relative to the sleeve and the plurality of needle tines causes the plurality of needle tines to deflect away from a central longitudinal axis of the sleeve against the distal ring to change an angle between a trajectory of the plurality of needle tines and the central longitudinal axis.
  • the deflector may include an anvil portion configured to abut the plurality of needle tines and apply a force to the plurality of needle tines against the distal ring.
  • distal advancement of the plurality of needle tines relative to the deflector a first distance may deflect the plurality of needle tines at a first angle relative to the central longitudinal axis
  • distal advancement of the plurality of needle tines relative to the deflector a second distance may deflect the plurality of needle tines at a second angle relative to the central longitudinal axis
  • retraction of the deflector relative to the sleeve and the plurality of needle tines a first distance may deflect the plurality of needle tines at a first angle relative to the central longitudinal axis
  • retraction of the deflector relative to the sleeve and the plurality of needle tines a second distance may deflect the plurality of needle tines at a second angle relative to the central longitudinal axis
  • a plurality of rounded grooves may be defined along a length of an outer surface of the deflector and each needle tine of the plurality of needle tines may be disposed within a respective rounded groove of the plurality of rounded grooves.
  • the plurality of needle tines may be formed of a shape memory material possessing a predefined curvature.
  • a distal end of the deflector may include a blunt dilator tip.
  • the handle assembly may include a first handle, a second handle, and a third handle.
  • the first handle may be operably coupled to the plurality of needle tines and configured to control movement of the needle tines relative to the deflector.
  • the second handle may be operably coupled to the sleeve and configured to control movement of the sleeve relative to the plurality of needle tines and the deflector.
  • the third handle may be operably coupled to the deflector and configured to control movement of the deflector relative to the plurality of needle tines and the sleeve.
  • the sleeve may be formed of a flexible material and the distal ring may be formed of a rigid material.
  • each needle tine of the plurality of needle tines may be independently movable relative to other needle tines of the plurality of needle tines.
  • a surgical intratumoral injection system in another aspect of the disclosure, includes a guide catheter and a surgical intratumoral injection instrument.
  • the guide catheter defines a lumen and is configured to be navigated to a target.
  • the surgical intratumoral injection instrument is configured to be inserted through the lumen of the guide catheter to access the target.
  • the surgical intratumoral injection instrument includes a supply chamber, a handle assembly, a sleeve extending from the handle assembly, a distal ring, a plurality of needle tines, and a deflector.
  • the plurality of needle tines extends through a lumen of the sleeve, is movable through the lumen of the sleeve via the handle assembly, and is configured to dispense a therapeutic agent from the supply chamber.
  • the deflector extends through the lumen and is movable through the lumen via the handle assembly. Retraction of the deflector relative to the sleeve and the plurality of needle tines causes the plurality of needle tines to deflect away from a central longitudinal axis of the sleeve against the distal ring to change an angle between a trajectory of the plurality of needle tines and the central longitudinal axis.
  • the deflector may include an anvil portion configured to abut the plurality of needle tines and apply a force to the plurality of needle tines against the distal ring.
  • distal advancement of the plurality of needle tines relative to the deflector a first distance may deflect the plurality of needle tines at a first angle relative to the central longitudinal axis
  • distal advancement of the plurality of needle tines relative to the deflector a second distance may deflect the plurality of needle tines at a second angle relative to the central longitudinal axis
  • retraction of the deflector relative to the sleeve and the plurality of needle tines a first distance may deflect the plurality of needle tines at a first angle relative to the central longitudinal axis
  • retraction of the deflector relative to the sleeve and the plurality of needle tines a second distance may deflect the plurality of needle tines at a second angle relative to the central longitudinal axis
  • a plurality of rounded grooves may be defined along a length of an outer surface of the deflector and each needle tine of the plurality of needle tines may be disposed within a respective rounded groove of the plurality of rounded grooves.
  • the plurality of needle tines may be formed of a shape memory material possessing a predefined curvature.
  • a distal end of the deflector may include a blunt dilator tip.
  • the handle assembly may include a first handle, a second handle, and a third handle.
  • the first handle may be operably coupled to the plurality of needle tines and configured to control movement of the needle tines relative to the deflector.
  • the second handle may be operably coupled to the sleeve and configured to control movement of the sleeve relative to the plurality of needle tines and the deflector.
  • the third handle may be operably coupled to the deflector and configured to control movement of the deflector relative to the plurality of needle tines and the sleeve.
  • the sleeve may be formed of a flexible material and the distal ring may be formed of a rigid material.
  • each needle tine of the plurality of needle tines may be independently movable relative to other needle tines of the plurality of needle tines.
  • a surgical intratumoral injection instrument in another aspect of the disclosure, includes a supply chamber, a handle assembly, a sleeve, and a plurality of needle tines configured to dispense a therapeutic agent from the supply chamber to a tumor.
  • the sleeve extends from the handle assembly and defines a lumen.
  • the plurality of needle tines extends through the lumen of the sleeve and is movable through the lumen of the sleeve via the handle assembly.
  • the plurality of needle tines is formed of a shape memory material configured to splay radially outward from a central longitudinal axis of the sleeve when the plurality of needle tines is deployed from the sleeve and configured to curve inward toward the central longitudinal axis of the sleeve as the plurality of needle tines is inserted into the tumor.
  • FIG. 1 is a side view of a surgical injection instrument in accordance with the disclosure
  • FIG. 2 is a side cross-sectional view of a distal portion of the surgical injection instrument of FIG. 1 with the surgical injection instrument in a first condition;
  • FIG. 3 is a side cross-sectional view of a distal portion of the surgical injection instrument of FIG. 1 with the surgical injection instrument in a second condition;
  • FIG. 4 is a side cross-sectional view of a distal portion of the surgical injection instrument of FIG. 1 with the surgical injection instrument in a third condition;
  • FIG. 5 is a front cross-sectional view of a portion of the surgical injection instrument of FIG. 1 in accordance with an aspect of the disclosure
  • FIG. 6A is a side perspective view of an example of needle tines of the surgical injection instrument of FIG. 1 in accordance with an aspect of the disclosure
  • FIG. 6B is a side perspective view of an example of needle tines of the surgical injection instrument of FIG. 1 in accordance with another aspect of the disclosure
  • FIG. 6C is a side perspective view of an example of needle tines of the surgical injection instrument of FIG. 1 in accordance with another aspect of the disclosure.
  • proximal is used generally to refer to that portion of the device that is closer to a clinician
  • distal is used generally to refer to that portion of the device that is farther from the clinician
  • clinician is used generally to refer to medical personnel including doctors, nurses, and support personnel or any other user of the disclosed instruments.
  • the disclosure describes a multi-needle injection instrument that is configured for intratumoral injection of therapeutic fluids to a target (e.g., tumor).
  • the disclosed surgical intratumoral injection instrument 200 is designed in a manner that can be operated with one hand, injects a therapeutic agent at predetermined volumes for each actuation of an actuator, and can be manipulated to uniformly inject the therapeutic agent into different regions of a target from a single access/entry point into the target, that is, without the need to remove and reinsert the instrument into the target multiple times.
  • FIG. 1 illustrates a surgical intratumoral injection system 10 including a guide catheter 100, an intratumoral injection instrument 200, and a supply chamber 300 configured to store a therapeutic agent “T”. Although the supply chamber 300 is illustrated as external to the intratumoral injection instrument 200, in aspects, the supply chamber 300 may be an internal component of the intratumoral injection instrument 200.
  • the guide catheter 100 may be flexible or rigid and is configured to be navigated to a target site within a patient and to act as a conduit for the intratumoral injection instrument 200 to access a target (e.g., tumor) located within the target site.
  • the guide catheter 100 may be navigated manually or robotically to the target site using any suitable navigation system, for example using an electromagnetic navigation system.
  • Either or both of the guide catheter 100 and the intratumoral injection instrument 200 may be handheld devices or devices configured to interface with a robotic arm of a surgical robotic system.
  • the intratumoral injection instrument 200 may be inserted through a lumen 110 of the guide catheter 100 such that a distal portion 200b of the intratumoral injection instrument 200 protrudes from the distal end 100b of the guide catheter 100 and into the target.
  • the intratumoral injection instrument 200 includes a handle assembly 220 at its proximal portion 200a and a sleeve 210, which defines a lumen 211, extending distally from the handle assembly 220.
  • the sleeve 210 may be flexible or rigid and includes a distal ring 214 formed of a rigid material at its distal end.
  • the intratumoral injection instrument 200 also includes a plurality of needle tines 240n (referred to individually as needle tines 240a, 240b. . .n) and a deflector 230 extending through the lumen 211 of the sleeve 210 from the handle assembly 220 along a central longitudinal axis “L” of the sleeve 210.
  • the needle tines 240a, 240b . . . n are movable through the lumen 211 of the sleeve 210 via the handle assembly 220 and are configured to dispense the therapeutic agent “T” from the supply chamber 300 into the target via actuation of an actuator 225.
  • any one or more of the plurality of needle tines 240n may be serve as a supply chamber configured to store the therapeutic agent “T” either in lieu of the supply chamber 300 or in conjunction with the supply chamber 300.
  • the plurality of needle tines 240n is coupled to a first handle 220a of the handle assembly 220 to control longitudinal movement of the plurality of needle tines 240n relative to at least one of the deflector 230 or the sleeve 210 along the central longitudinal axis “L”.
  • the first handle 220a of the handle assembly 220 includes individual selectable connections to each needle tine 240a, 240b... n of the plurality of needle tines 240n and is configured to control individual movement of each needle tine 240a, 240b. . .n relative to the others when selected for movement.
  • n may be controlled manually by the clinician via the handle assembly 220 and/or controlled robotically by a robotic arm of a surgical robotic system.
  • the handle assembly 220 may be configured to interface with a robotic arm of a surgical robotic system to facilitate robotic control (e.g., deployment, retraction, manipulation, positioning, placement, etc.) of each individual needle tine of the plurality of needle tines 240n.
  • one or more needle tines of the plurality of needle tines 240n may be configured to interface directly with a robotic arm of a surgical robotic system to facilitate direct robotic control of each individual needle tine of the plurality of needle tines 240n.
  • first handle 220a may include a lock component (not shown) to lock the longitudinal position of one or more of the plurality of needle tines 240n along the central longitudinal axis “L”.
  • the actuator 225 may be any suitable device or combination of devices, such as a valve, pump, and/or switch capable of initiating the delivery of the therapeutic agent “T” from the supply chamber 300 to the plurality of needle tines 240n for dispensing out of the plurality of needle tines 240n and into the target.
  • the plurality of needle tines 240n may be formed of alloys (e.g., nitinol, stainless steel, titanium, etc.) that allow for flexibility and possess shape memory characteristics.
  • the plurality of needle tines 240n are designed to be self-expanding and may be formed to have a preset curvature that causes the plurality of needle tines 240n to blossom from the central longitudinal axis “L” to an angle that folds back in a retrograde fashion. Such a configuration results in maximum angulation of the trajectory of the plurality of needle tines 240n relative to the central longitudinal axis “L”.
  • the deflector 230 includes a dilator tip 232 at its distal end which may be blunt to prevent atraumatic injuries to the target or tissue proximate the target within the target site during movement of the deflector 230 or navigation of the intratumoral injection instrument 200.
  • the deflector 230 includes a dilator tip 232 at its distal end that is needle-like (e.g., pointed) to enable the percutaneous insertion of the deflector 230 and/or the plurality of needle tines 240n into the target.
  • a portion of the deflector 230 includes an anvil portion 234 that depresses against the plurality of needle tines 240n as the deflector 230 is retracted proximally relative to the plurality of needle tines 240n and/or which the plurality of needle tines 240n can slide along as the plurality of needle tines 240n is advanced distally relative to the deflector 230. Depression of the anvil portion 234 against the plurality of needle tines 240n (during proximal retraction of the deflector 230) urges the plurality of needle tines 240n against the distal ring 214 to counter-deflect the plurality of needle tines 240n.
  • the distal ring 214 includes radius edge to minimize acute pressure and friction against the plurality of needle tines 240n. Additionally, in some aspects, the distal ring 214 includes a beveled or chamfered edge to further define the deployment angle of the plurality of needle tines 240n as the deflector 230 is proximally retracted.
  • FIG. 2 illustrates the distal portion 200b of the intratumoral injection instrument 200 in a condition (e.g., a first condition) for insertion through the lumen 110 of the guide catheter 100.
  • a condition e.g., a first condition
  • the deflector 230 and the plurality of needle tines 240n are in their fully retracted positions.
  • a portion of the dilator tip 232 protrudes from the lumen 211 of the sleeve 210 to aid in navigation of the intratumoral injection instrument 200 to the target site.
  • the plurality of needle tines 240n is fully retracted, the distal end of each needle tine 240a, 240b. .
  • the intratumoral injection instrument 200 may be visible under imaging guidance (e.g., fluoroscopic, whitelight, ultrasound, cone-beam computed tomography (“CBCT”), etc.) to visualize the placement of the distal portion 200b relative to the target and to visualize the deployment trajectories of the plurality of needle tines 240n within the target throughout the procedure.
  • imaging guidance e.g., fluoroscopic, whitelight, ultrasound, cone-beam computed tomography (“CBCT”), etc.
  • FIG. 3 illustrates the distal portion 200b of the intratumoral injection instrument 200 in a condition (e.g., a second condition) for a first delivery of the therapeutic agent “T” to the target.
  • a condition e.g., a second condition
  • the plurality of needle tines 240n is advanced distally (e.g., via manipulation of the first handle 220a of the handle assembly 220) to extend closer to, or beyond, the distal end of the deflector 230.
  • either the sleeve 210 is retracted proximally (e.g., via manipulation of the second handle 220b of the handle assembly 220) or the deflector 230 is distally advanced (e.g., via manipulation of the third handle 220c of the handle assembly 220) resulting in both the deflector 230 and the plurality of needle tines 240n being placed in the target with a distance dl between the anvil portion 234 of the deflector 230 and the distal end of the distal ring 214.
  • a first deployment angle 01 (e.g., obtuse) is formed between a trajectory of the plurality of needle tines 240n and the central longitudinal axis “L” and the therapeutic agent “T” is uniformly dispensed into the target from the plurality of needle tines 240n at the first deployment angle 01 via actuation of the actuator 225.
  • the deployment angle of the plurality of needle tines 240n may be changed to a second deployment angle 02 for uniform distribution of the therapeutic agent “T” from the plurality of needle tines 240n to another region of the target without removing the distal portion 200b from the target.
  • FIG. 4 illustrates the intratumoral injection instrument 200 in a condition (e.g., a third condition) for a second delivery of the therapeutic agent “T” to the target with the plurality of needle tines 240n positioned at a second deployment angle 02 (e.g., acute) relative to the central longitudinal axis “L”.
  • a second deployment angle 02 e.g., acute
  • the deflector 230 is retracted proximally (e.g., via manipulation of the third handle 220c of the handle assembly 220) while the sleeve 210 and the plurality of needle tines 240n are fixed in their longitudinal positions.
  • the deflector 230 is retracted proximally to create a smaller distance d2 between the anvil portion 234 of the deflector 230 and the distal end of the distal ring 214.
  • the anvil portion 234 depresses the outer surface of each needle tine 240a, 240b... n, forcing the plurality of needle tines 240n to deflect radially out away from the central longitudinal axis “L” to create the deployment angle 02 between the trajectory of the plurality of needle tines 240n and the central longitudinal axis “L”.
  • distal advancement and proximal retraction of the deflector 230 and/or the sleeve 210 may be controlled manually by the clinician via the handle assembly 220 and/or controlled roboticially by a robotic arm of a surgical robotic system.
  • the handle assembly 220 may be configured to interface with a robotic arm of a surgical robotic system to facilitate robotic control of the deflector 230 including the anvil portion 234 and/or to facilitate robotic control of the sleeve 210.
  • the deflector 230 and/or the sleeve 210 may be configured to interface directly with a robotic arm of a surgical robotic system to facilitate direct robotic control of the deflector 230 including the anvil portion 234 and/or to facilitate direct robotic control of the sleeve 210.
  • each needle tine 240a, 240b . . . n may be selected to be independently controlled and deployed by the first handle 220a (or another component of the handle assembly 220) such that only one needle tine or some needle tines of the plurality of needle tines 240n is moved to a different portion of the target upon movement of the first handle 220a (or other component of the handle assembly 220).
  • the actuator 225 may also be manipulated to select one or more specific needle tines 240a, 240b ... n of the plurality of needle tines 240n through which the therapeutic agent “T” will be delivered.
  • FIG. 5 illustrates an aspect of a deflector 230 including rounded grooves 234a... h (referred to collectively as a plurality of rounded grooves 234n) formed along a length of an outer surface of the deflector 230.
  • One needle tine 240a. . .h of the plurality of needle tines 240n is seated within a respective rounded groove 234a... h of the plurality of rounded grooves 234n, thereby reducing the overall combined diameter “D” of the plurality of needle tines 240n/deflector 230 combination.
  • a reduced overall combined diameter “D” enables the use of a smaller sleeve 210 for fitment within smaller guide catheters 100, which may be more useful or necessary for certain procedural applications.
  • FIGS. 6A-6C illustrate various aspects of needle tines that may be usable with the intratumoral injection instrument 200 (with or without the use of a deflector 230).
  • Each of the plurality of needle tines 240na (FIG. 6A), 240nb (FIG. 6B), and 240nc (FIG. 6C) are self-expanding and possess a preset curvature that changes the deployment angle of the plurality of needle tines 240na, 240nb, 240nc as they are deployed from the sleeve 210 and/or as they are inserted into a target.
  • each of the plurality of needle tines 240na, 240nb, 240nc may be usable with an intratumoral injection instrument 200 that does not include a deflector 230 as a deflector 230 is not necessary to change the deployment angle of the plurality of needle tines 240na, 240nb, 240nc.
  • FIG. 6A illustrates a plurality of needle tines 240na having a hypo-fork configuration. Each needle tine of the plurality of needle tines 240na splay outward upon exiting the sleeve 210. Additionally, the plurality of needle tines 240na could splay even further out upon engagement with the tumor “T” and upon further penetration into the tumor “T”.
  • FIG. 6B illustrates a plurality of needle tines 240nb having a distal-foci configuration. Each needle tine of the plurality of needle tines 240nb splay out promptly upon exiting the sleeve 210 and then curve inward upon engagement and interaction with the tumor “T”.
  • FIG. 6C illustrates a plurality of needle tines 240nc having a distal expansion configuration. The plurality of needle tines 240nc do not splay outward upon exiting the sleeve 210. Rather, the plurality of needle tines 240nc only splay outward upon insertion into the tumor “T”.
  • the configuration illustrated in FIG. 6C is particularly useful in applications that require intratumoral injection of the therapeutic agent into the peripheral boundaries of the tumor “T”.
  • each of the plurality of needle tines 240na, 240nb, 240nc may be configured to splay in a single plane and/or to splay in multiple planes (e.g., in a three-dimensional configuration) upon insertion into the tumor “T”.
  • the intratumoral injection instrument 200 is illustrated as a manually actuatable surgical instrument, but it is appreciated that the intratumoral injection instrument 200 may be an electrically powered surgical instrument including an electrically powered handle assembly that may support one or more batteries (not shown). It is envisioned that the disclosed aspects could also be incorporated into a surgical instrument that is configured for use with a robotic system that does not include a handle assembly, or to a surgical instrument including a manually actuated handle assembly.
  • An injection instrument comprising: a supply chamber configured to store a therapeutic agent; a handle assembly; a sleeve extending from the handle assembly and defining a lumen; a distal ring disposed at a distal end of the sleeve; a plurality of needle tines extending through the lumen of the sleeve and movable through the lumen of the sleeve via the handle assembly, wherein the plurality of needle tines is configured to dispense the therapeutic agent from the supply chamber; and a deflector extending through the lumen of the sleeve and movable through the lumen of the sleeve via the handle assembly, wherein retraction of the deflector relative to the sleeve and the plurality of needle tines causes the plurality of needle tines to deflect away from a central longitudinal axis of the sleeve against the distal ring to change an angle between
  • Example 2 The injection instrument of example 1, wherein the deflector includes an anvil portion configured to abut the plurality of needle tines and apply a force to the plurality of needle tines against the distal ring.
  • Example 3 The injection instrument according to any of the preceding examples, wherein: distal advancement of the plurality of needle tines relative to the deflector a first distance deflects the plurality of needle tines at a first angle relative to the central longitudinal axis; and distal advancement of the plurality of needle tines relative to the deflector a second distance deflects the plurality of needle tines at a second angle relative to the central longitudinal axis.
  • Example 4 The inj ection instrument according to any of the preceding examples, wherein: retraction of the deflector relative to the sleeve and the plurality of needle tines a first distance deflects the plurality of needle tines at a first angle relative to the central longitudinal axis; and retraction of the deflector relative to the sleeve and the plurality of needle tines a second distance deflects the plurality of needle tines at a second angle relative to the central longitudinal axis.
  • Example 5 The inj ection instrument according to any of the preceding examples, wherein a plurality of rounded grooves is defined along a length of an outer surface of the deflector and each needle tine of the plurality of needle tines is disposed within a respective rounded groove of the plurality of rounded grooves.
  • Example 6 The inj ection instrument according to any of the preceding examples, wherein the plurality of needle tines is formed of a shape memory material possessing a predefined curvature.
  • Example 7 The inj ection instrument according to any of the preceding examples, wherein a distal end of the deflector includes a blunt dilator tip.
  • Example 8 The inj ection instrument according to any of the preceding examples, wherein the handle assembly includes: a first handle operably coupled to the plurality of needle tines and configured to control movement of the needle tines relative to the deflector; a second handle operably coupled to the sleeve and configured to control movement of the sleeve relative to the plurality of needle tines and the deflector; and a third handle operably coupled to the deflector and configured to control movement of the deflector relative to the plurality of needle tines and the sleeve.
  • Example 9 The inj ection instrument according to any of the preceding examples, wherein the sleeve is formed of a flexible material and the distal ring is formed of a rigid material.
  • Example 10 The injection instrument according to any of the preceding examples, wherein each needle tine of the plurality of needle tines is independently movable relative to other needle tines of the plurality of needle tines.
  • Example 11 The injection instrument according to any of the preceding examples, further comprising a guide catheter defining a lumen and configured to be navigated to a target.
  • Example 12 The injection instrument according to example 11, wherein the injection instrument is configured to be inserted through the lumen of the guide catheter for placement at the target.
  • Example 13 The injection instrument according to any of the preceding examples, wherein a distal end of the deflector includes a dilator tip that is pointed and configured for percutaneous insertion of the deflector through tissue.
  • Example 14 The injection instrument according to any of the preceding examples, wherein the distal ring includes a chamfered edge.
  • Example 15 The injection instrument according to any of the preceding examples, wherein a distal end of each needle tine of the plurality of needle tines is disposed within the lumen of the sleeve when the plurality of needle tines is in a fully retracted position.

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un instrument chirurgical incluant une chambre d'alimentation, un ensemble poignée, un manchon s'étendant depuis l'ensemble poignée, une bague distale, une pluralité de dents d'aiguille et un déflecteur. La pluralité de dents d'aiguille s'étend à travers une lumière du manchon, est mobile à travers la lumière du manchon par l'intermédiaire de l'ensemble poignée, et est conçue pour distribuer un agent thérapeutique depuis la chambre d'alimentation. Le déflecteur s'étend à travers la lumière et est mobile à travers la lumière par l'intermédiaire de l'ensemble poignée. La rétraction du déflecteur par rapport au manchon et à la pluralité de dents d'aiguille amène les dents d'aiguille à s'écarter d'un axe longitudinal central du manchon contre la bague distale pour modifier un angle entre une trajectoire de la pluralité de dents d'aiguille et l'axe longitudinal central.
PCT/IB2024/057459 2023-08-07 2024-08-01 Instrument d'injection intratumorale à aiguilles multiples Pending WO2025032437A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363517949P 2023-08-07 2023-08-07
US63/517,949 2023-08-07
US18/740,737 2024-06-12
US18/740,737 US20250050066A1 (en) 2023-08-07 2024-06-12 Multi-needle intratumoral injection instrument

Publications (1)

Publication Number Publication Date
WO2025032437A1 true WO2025032437A1 (fr) 2025-02-13

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2024/057459 Pending WO2025032437A1 (fr) 2023-08-07 2024-08-01 Instrument d'injection intratumorale à aiguilles multiples

Country Status (1)

Country Link
WO (1) WO2025032437A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000040281A1 (fr) * 1999-01-06 2000-07-13 United States Surgical Corporation Dispositif d'injection pour la cartographie de tissus
EP2065069A1 (fr) * 2007-11-29 2009-06-03 National University of Ireland Galway Dispositif médical à base de cathéter et procédé d'administration d'un agent thérapeutique
US20120071832A1 (en) * 2009-06-05 2012-03-22 Cook Medical Technologies Llc Access sheath and needle assembly for delivering therapeutic material
US20190070389A1 (en) * 2015-10-12 2019-03-07 Swaminathan Jayaraman System and method for delivery of therapeutic agent through a catheter
CN112155685A (zh) * 2020-09-18 2021-01-01 武汉艾路通医疗科技有限公司 一种防治动脉狭窄的扩张注射系统
US10945787B2 (en) * 2012-10-29 2021-03-16 Ablative Solutions, Inc. Peri-vascular tissue ablation catheters

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000040281A1 (fr) * 1999-01-06 2000-07-13 United States Surgical Corporation Dispositif d'injection pour la cartographie de tissus
EP2065069A1 (fr) * 2007-11-29 2009-06-03 National University of Ireland Galway Dispositif médical à base de cathéter et procédé d'administration d'un agent thérapeutique
US20120071832A1 (en) * 2009-06-05 2012-03-22 Cook Medical Technologies Llc Access sheath and needle assembly for delivering therapeutic material
US10945787B2 (en) * 2012-10-29 2021-03-16 Ablative Solutions, Inc. Peri-vascular tissue ablation catheters
US20190070389A1 (en) * 2015-10-12 2019-03-07 Swaminathan Jayaraman System and method for delivery of therapeutic agent through a catheter
CN112155685A (zh) * 2020-09-18 2021-01-01 武汉艾路通医疗科技有限公司 一种防治动脉狭窄的扩张注射系统

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