Multi-needle intratumor injection instrument

Abstract

A surgical instrument includes a supply chamber, a handle assembly, a sleeve extending from the handle assembly, a distal ring, a plurality of tip forks, and a deflector. And a plurality of tip forks extending through the lumen of the sleeve, movable through the lumen of the sleeve via the handle assembly, and configured to dispense the 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 tip forks deflects the tip forks against the distal ring away from the central longitudinal axis of the sleeve to change an angle between a trajectory of the plurality of tip forks and the central longitudinal axis.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 517,949, filed August 7, 2023, and U.S. Patent Application Serial No. 18 / 740,737, filed June 12, 2024, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to surgical instruments, and more specifically to surgical instruments including multiple injection needles for intratumoral injection. Background Technology

[0003] Intratumoral injection is becoming increasingly common in interventional medicine. Intratumoral injection involves reaching the tumor and injecting the therapeutic agent; the idea is to isolate the agent to a localized area to avoid the systemic side effects historically associated with chemotherapy and other treatments.

[0004] In many solid tumors, the disease may be homogeneous throughout the mass. However, in some tumors, and particularly in lung tumors, the disease presents in a more heterogeneous state. This means that both diseased and healthy cells may be found within a single lung nodule. Due to this phenomenon, it is recommended to sample tissue from various locations within the nodule to confirm that the nodule is indeed malignant.

[0005] To effectively treat lesions via intratumoral injection, it is desirable to ensure uniform diffusion of the therapeutic agent throughout the entire volume of the lesion. This is achieved by using a single needle to enter the lesion through multiple capsule entry points. The challenge of this approach is that these pores in the tumor capsule can allow the therapeutic agent to diffuse beyond the boundaries and into other systemic organs, thus reducing the effectiveness of the procedure. Summary of the Invention

[0006] This disclosure relates to surgical instruments that include multiple injection needles to uniformly distribute therapeutic agents into different parts of a tumor for intratumoral injection.

[0007] According to various aspects of this disclosure, a surgical intratumoral injection device 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 extend through the lumen of the sleeve, are movable through the lumen of the sleeve via the handle assembly, and are configured to dispense therapeutic agents 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 against the distal ring away from the central longitudinal axis of the sleeve, thereby changing the angle between the trajectory of the plurality of needle tines and the central longitudinal axis.

[0008] On one hand, the deflector may include an anvil portion configured to abut against the plurality of needle forks and apply force to the plurality of needle forks to abut against the distal ring.

[0009] On one hand, advancing the plurality of needle forks a first distance relative to the deflector can cause the plurality of needle forks to deflect at a first angle relative to the central longitudinal axis, and advancing the plurality of needle forks a second distance relative to the deflector can cause the plurality of needle forks to deflect at a second angle relative to the central longitudinal axis.

[0010] On one hand, retracting the deflector relative to the sleeve and the plurality of needle forks by a first distance can deflect the plurality of needle forks relative to the central longitudinal axis at a first angle, and retracting the deflector relative to the sleeve and the plurality of needle forks by a second distance can deflect the plurality of needle forks relative to the central longitudinal axis at a second angle.

[0011] On one hand, a plurality of rounding grooves can be defined along the length of the outer surface of the deflector, and each of the plurality of needle forks can be disposed within a corresponding rounding groove in the plurality of rounding grooves.

[0012] On one hand, the multiple needle-point forks can be formed from shape memory materials with predefined curvature.

[0013] On one hand, the distal end of the deflector may include a blunt expander end.

[0014] In one aspect, the handle assembly may include a first handle, a second handle, and a third handle. The first handle is operably coupled to the plurality of needle forks and configured to control movement of the needle forks relative to the deflector. The second handle is operably coupled to the sleeve and configured to control movement of the sleeve relative to the plurality of needle forks and the deflector. The third handle is operably coupled to the deflector and configured to control movement of the deflector relative to the plurality of needle forks and the sleeve.

[0015] On the one hand, the sleeve can be formed of a flexible material, while the distal ring can be formed of a rigid material.

[0016] On the one hand, each of the plurality of needle forks can move independently relative to the other needle forks in the plurality of needle forks.

[0017] In another aspect of this disclosure, a surgical intratumoral injection system includes a guiding catheter and a surgical intratumoral injection device. The guiding catheter defines an inner lumen and is configured to navigate to a target. The surgical intratumoral injection device is configured to be inserted through the lumen of the guiding catheter to reach the target. The surgical intratumoral injection device includes a supply chamber, a handle assembly, a sleeve extending from the handle assembly, a distal ring, a plurality of needle forks, and a deflector. The plurality of needle forks extend through the lumen of the sleeve, are movable through the lumen of the sleeve via the handle assembly, and are configured to dispense therapeutic agents 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 forks causes the plurality of needle forks to deflect against the distal ring away from the central longitudinal axis of the sleeve, thereby changing the angle between the trajectory of the plurality of needle forks and the central longitudinal axis.

[0018] On one hand, the deflector may include an anvil portion configured to abut against the plurality of needle forks and apply force to the plurality of needle forks to abut against the distal ring.

[0019] On one hand, advancing the plurality of needle forks a first distance relative to the deflector can cause the plurality of needle forks to deflect at a first angle relative to the central longitudinal axis, and advancing the plurality of needle forks a second distance relative to the deflector can cause the plurality of needle forks to deflect at a second angle relative to the central longitudinal axis.

[0020] On one hand, retracting the deflector relative to the sleeve and the plurality of needle forks by a first distance can deflect the plurality of needle forks relative to the central longitudinal axis at a first angle, and retracting the deflector relative to the sleeve and the plurality of needle forks by a second distance can deflect the plurality of needle forks relative to the central longitudinal axis at a second angle.

[0021] On one hand, a plurality of rounding grooves can be defined along the length of the outer surface of the deflector, and each of the plurality of needle forks can be disposed within a corresponding rounding groove in the plurality of rounding grooves.

[0022] On one hand, the multiple needle-point forks can be formed from shape memory materials with predefined curvature.

[0023] On one hand, the distal end of the deflector may include a blunt expander end.

[0024] In one aspect, the handle assembly may include a first handle, a second handle, and a third handle. The first handle is operably coupled to the plurality of needle forks and configured to control movement of the needle forks relative to the deflector. The second handle is operably coupled to the sleeve and configured to control movement of the sleeve relative to the plurality of needle forks and the deflector. The third handle is operably coupled to the deflector and configured to control movement of the deflector relative to the plurality of needle forks and the sleeve.

[0025] On the one hand, the sleeve can be formed of a flexible material, while the distal ring can be formed of a rigid material.

[0026] On the one hand, each of the plurality of needle forks can move independently relative to the other needle forks in the plurality of needle forks.

[0027] In another aspect of this disclosure, an intratumoral injection surgical instrument includes a supply chamber, a handle assembly, a sleeve, and a plurality of needle forks configured to dispense a therapeutic agent from the supply chamber into a tumor. The sleeve extends from the handle assembly and defines an inner lumen. The plurality of needle forks extend through the inner lumen of the sleeve and are movable through the inner lumen of the sleeve via the handle assembly. The plurality of needle forks are formed of a shape memory material and are configured to open radially outward from the central longitudinal axis of the sleeve when deployed from the sleeve, and are configured to bend inward toward the central longitudinal axis of the sleeve when inserted into the tumor.

[0028] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the technology described in this disclosure will become clear from the specification, drawings, and claims. Attached Figure Description

[0029] The following description of various aspects of this disclosure is made with reference to the accompanying drawings, in which:

[0030] Figure 1 This is a side view of the surgical injection instrument based on this disclosure;

[0031] Figure 2 yes Figure 1 A side cross-sectional view of the distal portion of a surgical injection instrument, wherein the surgical injection instrument is in a first condition;

[0032] Figure 3 yes Figure 1 A side cross-sectional view of the distal portion of a surgical injection instrument, wherein the surgical injection instrument is in the second condition;

[0033] Figure 4 yes Figure 1 A side cross-sectional view of the distal portion of a surgical injection instrument, wherein the surgical injection instrument is in the third condition;

[0034] Figure 5 This is based on one aspect of this disclosure. Figure 1 A frontal cross-sectional view of a portion of a surgical injection instrument;

[0035] Figure 6A This is based on one aspect of this disclosure. Figure 1 A side-view stereoscopic view of an example of a needle fork of a surgical injection instrument;

[0036] Figure 6B This is based on another aspect of this disclosure. Figure 1 A side perspective perspective view of an example of a needle fork of a surgical injection instrument; and

[0037] Figure 6C This is based on another aspect of this disclosure. Figure 1 A side-view stereoscopic view of an example of a needle fork of a surgical injection instrument. Detailed Implementation

[0038] In this specification, the term "proximal" is generally used to refer to the portion of the device closer to the clinician, while the term "distal" is generally used to refer to the portion of the device further away from the clinician. Furthermore, the term "clinician" is generally used to refer to medical personnel, including doctors, nurses, and support staff, or any other user of the disclosed device.

[0039] This disclosure describes a multi-needle injection device configured for intratumoral injection of therapeutic fluid into a target (e.g., a tumor). The disclosed intratumoral injection device 200 is designed to be operated with one hand, injecting a predetermined volume of therapeutic agent with each actuation of the actuator, and can be manipulated to uniformly inject the therapeutic agent into different regions of the target from a single point of contact / entry, i.e., without requiring multiple removals and reinsertions of the device into the target.

[0040] Figure 1 A surgical intratumoral injection system 10 is shown, which includes a guiding catheter 100, an intratumoral injection device 200, and a supply chamber 300 configured to store a therapeutic agent "T". Although the supply chamber 300 is shown as being external to the intratumoral injection device 200, in all respects, the supply chamber 300 may be an internal component of the intratumoral injection device 200.

[0041] The guiding catheter 100 can be flexible or rigid and is configured to navigate to a target site within the patient's body, serving as a conduit for the intratumoral injection device 200 to access a target (e.g., a tumor) located within the target site. The guiding catheter 100 can be manually or robotically navigated to the target site using any suitable navigation system (e.g., an electromagnetic navigation system). Either or both of the guiding catheter 100 and the intratumoral injection device 200 can be handheld devices or devices configured to interface with the robotic arm of a surgical robot system. When the distal end 100b of the guiding catheter 100 is positioned close to the target site, the intratumoral injection device 200 can be inserted through the lumen 110 of the guiding catheter 100, such that the distal portion 200b of the intratumoral injection device 200 protrudes from the distal end 100b of the guiding catheter 100 and enters the target.

[0042] Continue to refer to Figure 1 And refer to other sources Figures 2 to 4 The intratumoral injection device 200 includes a handle assembly 220 at its proximal portion 200a and a sleeve 210 defining an inner cavity 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 device 200 also includes a plurality of needle forks 240n (individually referred to as needle forks 240a, 240b…n) and a deflector 230 extending from the handle assembly 220 along the central longitudinal axis “L” of the sleeve 210 through the inner cavity 211 of the sleeve 210.

[0043] The needle forks 240a, 240b…n (collectively referred to as the plurality of needle forks 240n) are movable via handle assembly 220 through the cavity 211 of sleeve 210 and are configured to dispense therapeutic agent “T” from supply chamber 300 into the target via actuation of actuator 225. In all aspects of this disclosure, any one or more of the plurality of needle forks 240n can be used as a supply chamber configured to store therapeutic agent “T”, as an alternative to or in conjunction with supply chamber 300.

[0044] In one aspect, a plurality of needle forks 240n are coupled to a first handle 220a of a handle assembly 220 for controlling longitudinal movement of the plurality of needle forks 240n relative to at least one of the deflectors 230 or sleeves 210 along a central longitudinal axis “L”. In another aspect, the first handle 220a of the handle assembly 220 includes a separate, selectable connection to each of the plurality of needle forks 240n 240a, 240b…n and is configured to control the individual movement of each needle fork 240a, 240b…n relative to the other needle forks when selected for movement. In all aspects of this disclosure, the movement of each individual needle fork 240a, 240b…n can be manually controlled by a clinician via the handle assembly 220 and / or robotically controlled by a robotic arm of a surgical robotic system. For example, the handle assembly 220 may be configured to interface with the robotic arm of a surgical robot system to facilitate robotic control (e.g., deployment, retraction, manipulation, positioning, placement, etc.) of each individual needle fork 240n. Alternatively, one or more needle forks 240n may be configured to interface directly with the robotic arm of a surgical robot system to facilitate direct robotic control of each individual needle fork 240n. Additionally, the first handle 220a or another portion of the handle assembly 220 may include a locking component (not shown) for locking one or more of the needle forks 240n in a longitudinal position 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 a therapeutic agent “T” from the supply chamber 300 to the needle forks 240n for dispensing from the needle forks 240n and into a target.

[0045] Multiple needle-point forks 240n can be formed from alloys that achieve flexibility and have shape memory properties (e.g., nitinol, stainless steel, titanium, etc.). In all aspects, the multiple needle-point forks 240n are designed to expand independently and can be formed with a preset curvature that causes the multiple needle-point forks 240n to expand from the central longitudinal axis "L" to an angle that folds backward in a counter-current manner. This configuration results in the trajectory of the multiple needle-point forks 240n forming the maximum angle relative to the central longitudinal axis "L".

[0046] In one aspect, the deflector 230 includes an expander tip 232 at its distal end, which may be blunt to prevent non-traumatic damage to the target or tissue near the target site during movement of the deflector 230 or navigation of the intratumoral injection device 200. In another aspect, the deflector 230 includes an expander tip 232 at its distal end, which is needle-shaped (e.g., pointed) to allow the deflector 230 and / or the plurality of needle tips 240n to be percutaneously inserted into the target. A portion of the deflector 230 includes an anvil portion 234 that presses against the plurality of needle tips 240n when the deflector 230 is retracted proximally relative to the plurality of needle tips 240n, and / or that the plurality of needle tips 240n can slide along the anvil portion when the deflector 230 is advanced distally relative to the deflector 230. The anvil portion 234 presses against the plurality of needle forks 240n (during the proximal retraction of the deflector 230) and pushes the plurality of needle forks 240n against the distal ring 214 to deflect the plurality of needle forks 240n in the opposite direction. In various aspects, the distal ring 214 includes rounded edges to minimize concentrated pressure and friction with the plurality of needle forks 240n. Additionally, in some aspects, the distal ring 214 includes beveled or chamfered edges to further define the deployment angle of the plurality of needle forks 240n as the deflector 230 retracts proximally.

[0047] Figure 2 The distal portion 200b of the intratumoral injection instrument 200 is shown in a position for insertion through the lumen 110 of the guiding catheter 100 (e.g., the first position). In this position, the deflector 230 and the plurality of needle forks 240n are in their fully retracted position. On one hand, and as... Figure 2 As demonstrated, when the deflector 230 is fully retracted, a portion of the dilator tip 232 protrudes from the lumen 211 of the sleeve 210 to aid in the navigation of the intratumoral injection instrument 200 to the target site. Furthermore, when the multiple needle forks 240n are fully retracted, the distal ends of each needle fork 240a, 240b…n are within the lumen 211 of the sleeve 210, thereby reducing the risk of damage to anatomical structures within the target site during the movement of the intratumoral injection instrument 200 within the target site and / or damage to other anatomical structures during navigation of the intratumoral injection instrument 200 to the target site. The intratumoral injection instrument 200 can be visible under imaging guidance (e.g., fluoroscopy, white light, ultrasound, cone-beam computed tomography (“CBCT”), etc.) to visualize the placement of the distal portion 200b relative to the target and the deployment trajectory of the multiple needle forks 240n within the target throughout the procedure.

[0048] Figure 3The distal portion 200b of the intratumoral injection device 200 is shown in the state of first delivery of the therapeutic agent "T" to the target (e.g., the second state). Specifically, after the distal portion 200b of the intratumoral injection device 200 is navigated to the target, a plurality of needle forks 240n are advanced distally (e.g., via the first handle 220a of the manipulator assembly 220) to extend closer to or beyond the distal end of the deflector 230. In addition to advancing the plurality of needle forks 240n distally, the sleeve 210 is retracted proximally (e.g., via the second handle 220b of the manipulator assembly 220) or the deflector 230 is advanced distally (e.g., via the third handle 220c of the manipulator assembly 220), such that both the deflector 230 and the plurality of needle forks 240n are positioned in the target, wherein the distance d1 is between the anvil portion 234 of the deflector 230 and the distal end of the distal ring 214. Under these conditions, a first deployment angle is formed between the trajectory of multiple needle-point forks 240n and the central longitudinal axis "L". 1 (e.g., obtuse angle), and the therapeutic agent "T" is actuated by actuator 225 at a first deployment angle. 1. Distribute the needle tips 240n evenly into the target.

[0049] The therapeutic agent "T" is deployed at the first angle with multiple needle-like forks at 240n. After evenly distributing multiple needle-point forks 240n to the target in the first positioning scenario, the deployment angle of the multiple needle-point forks 240n can be changed to a second deployment angle. 2, thereby allowing the therapeutic agent "T" to be evenly distributed from multiple needle forks 240n to another area of ​​the target without removing the distal portion 200b from the target.

[0050] In particular, Figure 4 An intratumoral injection device 200 is shown in a state of delivering the therapeutic agent "T" to the target for the second time (e.g., a third state), wherein multiple needle forks 240n are positioned at a second deployment angle relative to the central longitudinal axis "L". 2 (e.g., acute angle) positioning. To position the deployment angle from... 1 changed to 2. The deflector 230 is retracted proximally (e.g., via the third handle 220c of the operating handle assembly 220), thereby fixing the sleeve 210 and the plurality of needle forks 240n in their longitudinal position. Specifically, the deflector 230 is retracted proximally to create a small distance d2 between the anvil portion 234 of the deflector 230 and the distal end of the distal ring 214. When the deflector 230 is retracted proximally, the anvil portion 234 presses against the outer surface of each needle fork 240a, 240b…n, thereby forcing the plurality of needle forks 240n to deflect radially outward away from the central longitudinal axis “L”, creating a deployment angle between the trajectory of the plurality of needle forks 240n and the central longitudinal axis “L”. 2.

[0051] In all aspects of this disclosure, the distal advancement and proximal retraction of the deflector 230 and / or sleeve 210 can be manually controlled by a clinician via the handle assembly 220 and / or robotically controlled by the robotic arm of the surgical robot system. For example, the handle assembly 220 can be configured to interface with the robotic arm of the surgical robot system to facilitate robotic control of the deflector 230, including the anvil portion 234, and / or to facilitate robotic control of the sleeve 210. As another example, the deflector 230 and / or sleeve 210 can be configured to directly interface with the robotic arm of the surgical robot 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.

[0052] While two deployment angles have been described above, the deflector 230 and / or multiple needle forks 240n can be further manipulated to achieve more than two deployment angles, thereby allowing the therapeutic agent "T" to be injected additionally and uniformly into different regions of the target, as desired by the clinician for a given target and patient. Additionally, each needle fork 240a, 240b…n can be selected to be independently controlled and deployed by the first handle 220a (or another component of the handle assembly 220), such that when the first handle 220a (or another component of the handle assembly 220) moves, only one or more of the needle forks 240n move to different portions of the target. In various respects, the actuator 225 can also be manipulated to select one or more specific needle forks 240a, 240b…n of the multiple needle forks 240n through which the therapeutic agent "T" will be delivered.

[0053] Figure 5One aspect of the deflector 230 is shown, which includes rounding grooves 234a…h (collectively referred to as a plurality of rounding grooves 234n) formed along the length of the outer surface of the deflector 230. Each of the plurality of needle forks 240n 240a…h is disposed within a corresponding rounding groove 234a…h in the plurality of rounding grooves 234n, thereby reducing the overall combined diameter “D” of the plurality of needle forks 240n / deflector 230 combination. The reduced overall combined diameter “D” makes it possible to use a smaller sleeve 210 to fit within a smaller guide catheter 100, which may be more useful or necessary for certain surgical applications.

[0054] Figures 6A to 6C Various aspects of the needle fork that can be used with the intratumoral injection device 200 (with or without the deflector 230) are demonstrated. Multiple needle forks 240na ( Figure 6A ), 240nb ( Figure 6B ) and 240nc ( Figure 6C Each of the multiple needle tips 240na, 240nb, 240nc is self-expanding and has a preset curvature that alters the deployment angle of these needle tips as they are deployed from the sleeve 210 and / or inserted into the target. Specifically, each of the multiple needle tips 240na, 240nb, 240nc can be used with an intratumoral injection device 200 that does not include a deflector 230, since the deflector 230 is not necessary to alter the deployment angle of the multiple needle tips 240na, 240nb, 240nc.

[0055] Figure 6A Multiple needle forks 240na with a low-forking configuration are shown. Each of the multiple needle forks 240na flares outward as it exits the sleeve 210. In addition, the multiple needle forks 240na can flare outward even further as they engage with the tumor “T” and penetrate further into the tumor “T”. Figure 6B Multiple needle forks 240nb with a distal focusing configuration are shown. Each of the multiple needle forks 240nb rapidly opens outward upon exiting the sleeve 210 and then bends inward as it engages and interacts with the tumor “T”. Figure 6C Multiple needle forks 240nc with a distally expanded configuration are shown. The multiple needle forks 240nc do not flare outward upon exiting the sleeve 210. Instead, the multiple needle forks 240nc flare outward only upon insertion into the tumor “T”. Figure 6CThe illustrated configuration is particularly useful in applications requiring intratumoral injection of therapeutic agents into the peripheral boundaries of a tumor “T”. It should be understood that each of the plurality of needle forks 240na, 240nb, 240nc can be configured to open in a single plane and / or in multiple planes when inserted into the tumor “T” (e.g., in a three-dimensional configuration).

[0056] The intratumoral injection device 200 is shown as a manually actuated surgical instrument; however, it should be understood that the intratumoral injection device 200 can be an electrically powered surgical instrument including a power handle assembly that can support one or more batteries (not shown). It is conceivable that the disclosed aspects can also be incorporated into surgical instruments configured for use with robotic systems that do not include a handle assembly, or into surgical instruments that include a manually actuated handle assembly.

[0057] Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is contemplated that elements and features illustrated or described in connection with one exemplary embodiment may be combined with elements and features of another exemplary embodiment without departing from the scope of this disclosure. Furthermore, those skilled in the art will understand further features and advantages of this disclosure based on the embodiments described above. Therefore, this disclosure is not limited to what has been specifically shown and described, except as indicated by the appended claims.

[0058] The following examples further illustrate this disclosure.

[0059] Example 1. An injection device comprising: a supply chamber configured to store a therapeutic agent; a handle assembly; a sleeve extending from the handle assembly and defining an inner cavity; a distal ring disposed at a distal end of the sleeve; a plurality of needle forks extending through the inner cavity of the sleeve and movable via the handle assembly through the inner cavity of the sleeve, wherein the plurality of needle forks are configured to dispense a therapeutic agent from the supply chamber; and a deflector extending through the inner cavity of the sleeve and movable via the handle assembly through the inner cavity of the sleeve, wherein retraction of the deflector relative to the sleeve and the plurality of needle forks causes the plurality of needle forks to deflect against the distal ring away from a central longitudinal axis of the sleeve, thereby changing the angle between the trajectory of the plurality of needle forks and the central longitudinal axis.

[0060] Example 2. An injection device as described in Example 1, wherein the deflector includes an anvil portion configured to abut against the plurality of needle forks and apply force to the plurality of needle forks against the distal ring.

[0061] Example 3. An injection device according to any one of the preceding examples, wherein: the plurality of needle forks are advanced distally a first distance relative to the deflector such that the plurality of needle forks are deflected at a first angle relative to the central longitudinal axis; and the plurality of needle forks are advanced distally a second distance relative to the deflector such that the plurality of needle forks are deflected at a second angle relative to the central longitudinal axis.

[0062] Example 4. An injection device according to any one of the preceding examples, wherein: the deflector retracts a first distance relative to the sleeve and the plurality of needle forks such that the plurality of needle forks deflect at a first angle relative to the central longitudinal axis; and the deflector retracts a second distance relative to the sleeve and the plurality of needle forks such that the plurality of needle forks deflect at a second angle relative to the central longitudinal axis.

[0063] Example 5. An injection device according to any one of the preceding examples, wherein a plurality of rounding grooves are defined along the length of the outer surface of the deflector, and each of the plurality of needle forks is disposed within a corresponding rounding groove in the plurality of rounding grooves.

[0064] Example 6. An injection device according to any one of the preceding examples, wherein the plurality of needle tips are formed of a shape memory material having a predefined curvature.

[0065] Example 7. An injection device according to any one of the preceding examples, wherein the distal end of the deflector includes a blunt dilator tip.

[0066] Example 8. An injection device according to any one of the foregoing examples, wherein the handle assembly comprises: a first handle operably coupled to the plurality of needle forks and configured to control movement of the needle forks 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 forks 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 forks and the sleeve.

[0067] Example 9. An injection device according to any one of the foregoing examples, wherein the sleeve is formed of a flexible material and the distal ring is formed of a rigid material.

[0068] Example 10. An injection device according to any one of the preceding examples, wherein each of the plurality of needle forks is movable independently relative to the other needle forks of the plurality of needle forks.

[0069] Example 11. The injection device according to any one of the foregoing examples further includes a guiding catheter that defines an inner lumen and is configured to navigate to a target.

[0070] Example 12. An injection device according to Example 11, wherein the injection device is configured to be inserted through the lumen of the guiding catheter to be placed at the target.

[0071] Example 13. An injection device according to any one of the preceding examples, wherein the distal end of the deflector includes an expander tip that is pointed and configured for percutaneous insertion of the deflector through tissue.

[0072] Example 14. An injection device according to any of the preceding examples, wherein the distal ring includes a chamfered edge.

[0073] Example 15. An injection device according to any one of the preceding examples, wherein, when the plurality of needle forks are in the fully retracted position, the distal end of each of the plurality of needle forks is disposed within the inner cavity of the sleeve.

Claims

1. An injection device, comprising: Supply chamber (300), the supply chamber being configured to store therapeutic agents ("T"); Handle assembly (220); Sleeve (210), which extends from the handle assembly (220) and defines an inner cavity (211); Distal ring (214), the distal ring being disposed at the distal end of the sleeve (210); A plurality of needle forks (240n) extending through the cavity (211) of the sleeve (210) and movable through the cavity (211) of the sleeve (210) via the handle assembly (220), wherein the plurality of needle forks (240n) are configured to dispense a therapeutic agent ("T") from the supply chamber (300); and A deflector (230) extends through the inner cavity (211) of the sleeve (210) and is movable through the inner cavity (211) of the sleeve (210) via the handle assembly (220). The deflector (230) is characterized in that the retraction of the deflector (230) relative to the sleeve (210) and the plurality of needle forks (240n) causes the plurality of needle forks (240n) to deflect against the distal ring (214) away from the central longitudinal axis ("L") of the sleeve (210), thereby changing the angle between the trajectory of the plurality of needle forks (240n) and the central longitudinal axis ("L").

2. The injection device according to claim 1, wherein, The deflector (230) includes an anvil portion (234) configured to abut against the plurality of needle forks (240n) and apply force to the plurality of needle forks (240n) to abut against the distal ring (214).

3. The injection device according to any one of the preceding claims, wherein: The plurality of needle forks (240n) are advanced a first distance distally relative to the deflector (230) such that the plurality of needle forks (240n) are deflected at a first angle relative to the central longitudinal axis ("L"); and The plurality of needle forks (240n) are advanced a second distance to the distal side relative to the deflector (230) so that the plurality of needle forks (240n) are deflected at a second angle relative to the central longitudinal axis ("L").

4. The injection device according to any one of the preceding claims, wherein: The deflector (230) retracts a first distance relative to the sleeve (210) and the plurality of needle forks (240n) such that the plurality of needle forks (240n) deflect at a first angle relative to the central longitudinal axis ("L"); and The deflector (230) retracts a second distance relative to the sleeve (210) and the plurality of needle forks (240n) to deflect the plurality of needle forks (240n) at a second angle relative to the central longitudinal axis ("L").

5. The injection device according to any one of the preceding claims, wherein, A plurality of rounding grooves (234n) are defined along the length of the outer surface of the deflector (230), and each of the plurality of needle forks (240n) is disposed in a corresponding rounding groove (234n) among the plurality of rounding grooves.

6. The injection device according to any one of the preceding claims, wherein, The plurality of needle-point forks (240n) are formed from shape memory material with predefined curvature.

7. The injection device according to any one of the preceding claims, wherein, The distal end of the deflector (230) includes a blunt expander end (232).

8. The injection device according to any one of the preceding claims, wherein, The handle assembly (220) includes: A first handle (220a) is operably coupled to the plurality of needle forks (240n) and configured to control the movement of the plurality of needle forks (240n) relative to the deflector (230); A second handle (220b), operably coupled to the sleeve (210) and configured to control the movement of the sleeve (210) relative to the plurality of needle forks (240n) and the deflector (230); and A third handle (220c) is operably coupled to the deflector (230) and configured to control the movement of the deflector (230) relative to the plurality of needle forks (240n) and the sleeve (210).

9. The injection device according to any one of the preceding claims, wherein, The sleeve (210) is formed of a flexible material, while the distal ring (214) is formed of a rigid material.

10. The injection device according to any one of the preceding claims, wherein, Each of the plurality of needle forks (240n) is capable of moving independently relative to the other needle forks (240n).

11. The injection device according to any one of the preceding claims, further comprising a guide catheter (100) defining an inner lumen (110) and configured to navigate to a target.

12. The injection device according to claim 11, wherein, The injection device (200) is configured to be inserted through the lumen (110) of the guiding catheter (100) to be placed at the target.

13. The injection device according to any one of the preceding claims, wherein, The distal end of the deflector (230) includes an expander tip (232) which is pointed and configured for percutaneous insertion of the deflector (230) through tissue.

14. The injection device according to any one of the preceding claims, wherein, The distal ring (214) includes a chamfered edge.

15. The injection device according to any one of the preceding claims, wherein, When the plurality of needle forks (240n) are in the fully retracted position, the distal end of each of the plurality of needle forks (240n) is disposed within the inner cavity (211) of the sleeve 210.

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