This disclosure is generally related to surgical instruments and, more particularly, to surgical instruments including a plurality of injection needles for intratumoral injections.
Clinical acceptance of intratumoral injection is becoming more prevalent in interventional medicine. 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.
In many solid tumors, 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.
To effectively treat the lesion with intratumoral injection it is desirable to ensure uniform diffusion of a therapy agent across the entire volume of the lesion. This is accomplished with a single needle that enters the lesion utilizing multiple capsular invasion points. The challenge with this concept is that these holes in the tumor capsule allow for the therapy agent to diffuse outside the boundary and into other systemic organs, thus reducing the effectiveness of the procedure.
This disclosure is directed to surgical instruments including a plurality of injection needles to uniformly dispense a therapeutic agent into different portions of a tumor for intratumoral injections.
In accordance with aspects of the disclosure, 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.
In an aspect, 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.
In an aspect, 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, and 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.
In an aspect, 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, and 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.
In an aspect, 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.
In an aspect, the plurality of needle tines may be formed of a shape memory material possessing a predefined curvature.
In an aspect, a distal end of the deflector may include a blunt dilator tip.
In an aspect, 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.
In an aspect, the sleeve may be formed of a flexible material and the distal ring may be formed of a rigid material.
In an aspect, each needle tine of the plurality of needle tines may be independently movable relative to other needle tines of the plurality of needle tines.
In another aspect of the disclosure, a surgical intratumoral injection system 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.
In an aspect, 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.
In an aspect, 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, and 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.
In an aspect, 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, and 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.
In an aspect, 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.
In an aspect, the plurality of needle tines may be formed of a shape memory material possessing a predefined curvature.
In an aspect, a distal end of the deflector may include a blunt dilator tip.
In an aspect, 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.
In an aspect, the sleeve may be formed of a flexible material and the distal ring may be formed of a rigid material.
In an aspect, each needle tine of the plurality of needle tines may be independently movable relative to other needle tines of the plurality of needle tines.
In another aspect of the disclosure, a surgical intratumoral injection instrument 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.
The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
Various aspects of the disclosure are described herein below with reference to the drawings, wherein:
In this description, the term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician. Further, the term “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.
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. Upon placement of the distal end 100b of the guide catheter 100 proximate the target site, 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.
With continued reference to
The needle tines 240a, 240b . . . n (referred to collectively as the plurality of needle tines 240n) 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. In aspects of the present disclosure, 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.
In an aspect, 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”. In aspects, 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. In aspects of the present disclosure, movement of each individual needle tine 240a, 240b . . . 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. For example, 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. By way of another example, 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. Additionally, the first handle 220a, or another portion of the handle assembly 220, 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. In aspects, 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”.
In an aspect, 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. In other aspects, 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. In aspects, 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.
After the therapeutic agent “T” is uniformly dispensed into the target from the plurality of needle tines 240n with the plurality of needle tines 240n positioned at the first deployment angle θ1, the deployment angle of the plurality of needle tines 240n may be changed to a second deployment angle θ2 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.
In particular,
In aspects of the present disclosure, 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. For example, 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. By way of another example, 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.
While two deployment angles are described above, the deflector 230 and/or plurality of needle tines 240n may be further manipulated to achieve more than two deployment angles for additional uniform injection of the therapeutic agent “T” to different regions of the target, as a clinician desires for a given target and patient. Additionally, 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). In aspects, 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.
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.
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the disclosure. Also, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.
This application claims the benefit of the filing date of provisional U.S. Patent Application No. 63/517,949 filed on Aug. 7, 2023.
Number | Date | Country | |
---|---|---|---|
63517949 | Aug 2023 | US |