An ablation device with stable delivery function

Abstract

The application provides an ablation device with stable conveying function, comprising a main shell, a transmission catheter and a conveying assembly, the conveying assembly comprising a puncture needle with a puncture structure at a distal end, a driven part fixedly connected with the puncture needle, a driving part for driving the driven part and a biasing part; the driving part is in transmission connection with the driven part at a locking position and an unlocking position, and the driving part is capable of driving the movement of the driven part at the unlocking position to make the puncture needle extend out or retract into the distal end of the transmission catheter, and the driving part is limited to drive the movement of the driven part at the unlocking position. Through the improvement of the driving mode of the conveying assembly for conveying the ablation electrode, the driving part is limited at the unlocking position to drive the movement of the driven part, and can be switched to the state capable of driving the driven part at any time, so that when the puncture needle is inserted into the target tissue, the problem of puncture needle retraction or displacement caused by muscle contraction shaking can be effectively solved.

Description

Technical Field

[0001] This invention relates to medical devices, and more particularly to an ablation device with stable delivery function. Background Technology

[0002] According to statistics from the World Health Organization, approximately 7 million people die from cancer worldwide each year, with its proportion of deaths rising from 12.6% to 17.9%. In developing countries, the average mortality rate from malignant tumors is 90%. Clearly, malignant tumors have become a global medical challenge. Various ablation techniques have emerged in response to this trend. Compared to traditional treatments such as surgery, chemotherapy, and radiotherapy, ablation techniques not only achieve comparable efficacy to traditional surgery but also offer unique advantages in preserving the patient's appearance. Currently, the market primarily utilizes temperature-based ablation techniques, such as radiofrequency ablation, microwave ablation, laser ablation, high-intensity focused ultrasound (HIFU), and cryoablation.

[0003] The above ablation principles primarily achieve tissue cell necrosis through changes in the temperature surrounding the tissue. However, due to the "heat sink effect," nerves, lymph nodes, and blood vessels in the ablation area suffer varying degrees of damage. Pulse ablation technology differs from other physical therapies based on thermal ablation principles, such as radiofrequency, microwave, cryotherapy, and focused ultrasound. This technology applies a high-voltage pulsed electric field with a pulse width in the microsecond range around tumor cells. This disrupts the stability of the tumor cell membrane surface, creating multiple hydrophilic micropores, thereby disrupting cell homeostasis and ultimately leading to cell death. The emergence of the irreversible electroporation theory offers a new approach to the treatment of malignant tumors and has significant application value for hepatobiliary and pancreatic tumors with complex structures adjacent to blood vessels, bile ducts, and pancreatic ducts.

[0004] Although the technology has been gradually improved in terms of procedures and products, achieving truly minimally invasive treatment and precise, flexible access to the tumor remains a challenge for pulsed ablation surgery. During pulsed ablation, the device needs to be both flexible and stable. Flexibility is reflected in precise access to the tumor and the ability to adjust it at any time, while stability is reflected in effectively preventing needle retraction or displacement caused by muscle contraction and tremors when inserted into the target tissue. Therefore, there is a need for an ablation device that can achieve the above-mentioned effects. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides an ablation device with stable delivery function. By improving the driving method of the delivery component used to deliver the ablation electrode, the driving component is restricted in the unlocked position, thereby driving the movement of the driven component. Furthermore, it can switch to a state that can drive the driven component at any time, effectively solving the problem of needle retraction or displacement caused by muscle contraction and shaking when the puncture needle is inserted into the target tissue.

[0006] Specifically, the following options are included:

[0007] An ablation device with stable delivery function includes:

[0008] The main housing is connected to a transmission conduit extending distally;

[0009] A delivery assembly, at least partially disposed on the main housing, for delivering the ablation electrode through the delivery conduit to a distal tissue site;

[0010] The delivery assembly includes a puncture needle with a puncture structure at its distal end, a follower fixedly connected to the puncture needle, a drive member for driving the follower, and a biasing member.

[0011] The drive member is movable relative to the main housing between a locked position and an unlocked position, and the biasing member applies a biasing force toward the locked position to the drive member;

[0012] The driving member is connected to the driven member in both the locked and unlocked positions. In the unlocked position, the driving member can drive the movement of the driven member so that the puncture needle extends or retracts into the distal end of the transmission catheter. In the unlocked position, the driving member is restricted from driving the movement of the driven member.

[0013] More preferably, the main housing is provided with a first locking member, and the driving member is provided with a second locking member. When the driving member is in the locked position, the first locking member and the second locking member are engaged to restrict the driving member from driving the driven member, but do not restrict the driving member from moving to the unlocked position.

[0014] More preferably, the driving component is a driving gear, and when the first locking component engages with the second locking component, the rotation of the driving gear is restricted.

[0015] More preferably, the driven member is a rack, and when the drive gear is in the locked position and the unlocked position, at least part of the drive teeth of the drive gear are located in the tooth grooves of the rack.

[0016] More preferably, the second locking member is a secondary gear disposed on the side of the drive gear, and the first locking member is a locking engagement tooth disposed on the inner wall of the main housing that matches the secondary gear.

[0017] More preferably, the main housing is provided with a gear opening, and the drive gear is at least partially located outside the gear opening when it is in the locked position.

[0018] More preferably, the biasing element is a curved spring sheet, with both ends of the spring sheet fixedly connected to the inner wall of the main housing, and the middle part of the spring sheet abutting against the secondary gear.

[0019] More preferably, the main housing further includes an electrode delivery port for the ablation electrode to pass through and enter the inner cavity of the puncture needle.

[0020] More preferably, the transmission conduit includes a puncture needle channel for the puncture needle to extend from and an image acquisition channel for accommodating the image acquisition device.

[0021] More preferably, the main housing is further provided with an image acquisition channel opening for the image acquisition device to extend into the image acquisition channel.

[0022] As described above, the present invention has the following beneficial effects:

[0023] 1) By improving the driving method of the delivery component used to deliver the ablation electrode, the driving component is restricted in the unlocked position, thereby driving the movement of the driven component, and can be switched to the state that can drive the driven component at any time. This can effectively solve the problem of needle retraction or displacement caused by muscle contraction and shaking when the puncture needle is inserted into the target tissue.

[0024] 2) By utilizing the gear and rack mechanism, the depth of the puncture needle is precisely controlled, ensuring accurate puncture. It can also be locked at any time to prevent accidental triggering of the puncture needle and prevent the puncture needle from extending during positioning, observation, or other processes where it does not need to extend from the sheath, thus avoiding injury to the cavity tissue and improving safety.

[0025] 3) The delivery channel of the ablation device passes through a natural cavity and is used in conjunction with the image acquisition channel that houses the image acquisition device. This allows for real-time observation of the remote end. The remote end can be bent to observe the target area via a handle, achieving zero surface wounds. At the same time, the bending function of the remote end increases the flexibility of the product and makes it more adaptable. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the present invention, the accompanying drawings used in the description of the embodiments or prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0027] Figure 1 This is a three-dimensional structural diagram of the ablation device according to an embodiment of the present invention;

[0028] Figure 2 This is a side view of the ablation device according to an embodiment of the present invention;

[0029] Figure 3 for Figure 2 A partially enlarged side view after removing a portion of the main casing;

[0030] Figure 4 This is a three-dimensional structural diagram of the ablation device according to the application embodiment after removing part of the main housing;

[0031] Figure 5 for Figure 2 Side view after removing part of the main housing and drive gear;

[0032] Figure 6 This is a schematic diagram of the drive gear and the auxiliary gear in an embodiment of the present invention;

[0033] Figure 7 for Figure 3 A structural diagram from an oblique perspective;

[0034] Figure 8 for Figure 7 A magnified view of a portion of the image;

[0035] Figure 9 for Figure 8 Further expand the structural diagram;

[0036] Figure 10 This is a front view of the ablation device according to an embodiment of the present invention;

[0037] Figure 11 This is a magnified view of the distal end of the transfer catheter;

[0038] Figure 12 This is a side view of the bending knob according to an embodiment of the present invention;

[0039] Figure 13 for Figure 12 Enlarged view of a specific area;

[0040] Figure 14 This is a schematic diagram of the structure of the delivery catheter before and after bending.

[0041] Figure 15 This is a schematic diagram of the structure where the puncture needle extends after the catheter is bent.

[0042] The corresponding figure labels are as follows:

[0043] Main housing 1, locking engagement teeth 11, gear opening 12, image acquisition channel opening 13, electrode delivery port 14;

[0044] 2. Transmission conduit, 21. Puncture needle channel, 22. Image acquisition channel, 23. Pull wire channel; 3. Delivery assembly, 31. Puncture needle, 32. Rack, 33. Drive gear, 34. Spring, 35. Secondary gear, 36. Rigid tube;

[0045] Bending control component 4, pull wire 41, bending knob 42, winding part, winding groove 421, pull wire fixing hole 422, twisting protrusion 423;

[0046] Ablation electrode 5 pulse connection part 51. Detailed Implementation

[0047] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. In this embodiment, "proximal end" refers to the direction closer to the operator; "distal end" refers to the direction farther away from the operator. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0048] Example 1:

[0049] See Figure 1-15 This invention provides an ablation device with stable delivery function, specifically including a main housing 1 for the operator to hold. The main housing 1 houses most of the mechanisms of the ablation device of this embodiment. The main housing 1 is connected to a delivery conduit 2 extending distally. A delivery component 3 is at least partially disposed within the main housing 1, used to deliver the ablation electrode 5 through the delivery conduit 2 to the distal tissue. Specifically, the delivery component 3 includes a puncture needle 31 with a puncture structure at its distal end, a follower fixedly connected to the puncture needle 31, a drive component for driving the follower, and a biasing component. After the distal end of the delivery conduit 2 reaches the tissue location to be ablated, the puncture needle 31 extends from the distal end of the delivery conduit to puncture. After puncturing to the target location, the ablation electrode 5 is inserted into the puncture needle to reach the target tissue, and an electrical pulse is released for pulse ablation.

[0050] In this embodiment, to prevent the puncture needle from retracting or shifting due to muscle contraction and vibration when the needle is inserted into the target object after it has been extended, the following solution is provided:

[0051] The drive unit is movable relative to the main housing 1 between a locked position and an unlocked position, and the biasing unit applies a biasing force toward the locked position to the drive unit;

[0052] The driving member is connected to the driven member in both the locked and unlocked positions. In the unlocked position, the driving member can drive the movement of the driven member so that the puncture needle 31 extends or retracts into the distal end of the transmission conduit 2. In the unlocked position, the driving member is restricted from driving the movement of the driven member.

[0053] In this embodiment, the driving component can switch between a locked position and an unlocked position under the operator's control. Both positions of the driving component are connected to the driven component via a transmission mechanism. This means that if the driving component can generate a driving action, the driven component will inevitably move accordingly; conversely, if the driving component's movement is restricted, the driven component's movement will also be restricted. This achieves the switching between locked and unlocked states. In this embodiment, a biasing component is also provided. The biasing component applies a biasing force to the driving component towards the locked position, allowing the driving component to automatically reset to the locked position when no external force is applied by the operator, thus maintaining the stability of the puncture needle. Furthermore, this embodiment not only solves the problem of puncture needle retraction or displacement caused by muscle contraction and vibration when the puncture needle is inserted into the target object after extension, but also ensures that the puncture needle remains stationary relative to the transmission catheter 2 when not in the puncture position because the driving component is in the locked position. Therefore, it also achieves the ability to lock at any time, solving the problem of accidental triggering of the puncture needle and preventing the puncture needle from extending during positioning, observation, or other processes that do not require it to extend from the sheath, thus avoiding the technical problem of puncturing the cavity tissue.

[0054] In order to further achieve the effect of restricting the drive when the drive member is in the locked position, in this embodiment, the main housing 1 is provided with a first locking member and the drive member is provided with a second locking member. When the drive member is in the locked position, the first locking member and the second locking member are engaged to restrict the drive member from driving the driven member, but do not restrict the drive member from moving to the unlocked position.

[0055] Specifically, in conjunction with the appendix Figure 3-6 To further explain how the present invention achieves the above-described locking method:

[0056] In this embodiment, the driving member is a driving gear 33. When the first locking member and the second locking member are engaged, the rotation of the driving gear 33 is restricted. The driven member is a rack 32. When the driving gear 33 is in the locked position and the unlocked position, at least part of the driving teeth of the driving gear 33 are located in the tooth groove of the rack 32.

[0057] In other words, the drive gear 33 can switch between the locked and unlocked positions by moving relative to the main housing 1, specifically in a linear motion. The driving method involves the rotation of the drive gear 33 driving the rack 32 to move distally, thereby moving the puncture needle 31 forward to extend from the transmission conduit 2 for puncture, or driving the rack 32 proximally to retract the puncture needle 31 into the transmission conduit 2. When the first and second locking members engage, they restrict the rotation of the drive gear 33, thus preventing the rack 32 from moving forward or backward, thereby locking the puncture needle 31. While the engagement of the first and second locking members restricts the rotation of the drive gear 33, it does not restrict its linear motion that is not parallel to the rack's direction of movement. Therefore, it does not obstruct the drive gear 33 from moving from the locked position to the unlocked position via linear motion.

[0058] More preferably, the second locking element is a secondary gear 35 located on the side of the drive gear 33, and the first locking element is a locking engagement tooth 11 located on the inner wall of the main housing 1 that matches the secondary gear 35. The biasing element is a bent spring 34, with both ends of the spring 34 fixedly connected to the inner wall of the main housing 1, and the middle part of the spring 34 abutting against the secondary gear 35. When the drive gear 33 is not subjected to external force, the spring 34 continuously provides an upward biasing force to the secondary gear 35, causing the locking engagement tooth 11 to always engage with the teeth of the secondary gear 35, thereby preventing the rotation of the secondary gear 35. The secondary gear 35 is fixed relative to the drive gear 33, thus further preventing the rotation of the drive gear 33. When pressure is applied to the drive gear 33, the spring piece 34 deforms under the pressure, allowing the drive gear 33 to move downwards until the locking engagement teeth 11 disengage from the teeth of the secondary gear 35. At this point, the drive gear 33 reaches the unlocked position and can rotate, thereby driving the rack 32 to drive the puncture needle 31. When the hand is released, the drive gear 33 returns to the locked position, locking the puncture needle 31. In this embodiment, the spring piece 34 can be configured as an arc-shaped structure or a trapezoidal structure, or other forms capable of achieving biased pressure, housed inside the main housing 1. The two ends of the two spring pieces are respectively connected to concave grooves in the main housing to support the spring pieces. The spring piece 34 can abut against the secondary gear 35 to apply biased pressure, or it can abut against other positions that do not affect the drive. The secondary gear 35 can be a single gear located on one side of the drive gear 33, or two gears symmetrically arranged on both sides. The number of spring pieces 34 and the number of locking engagement teeth 11 are set accordingly with the number of secondary gears 35.

[0059] In this embodiment, the main housing 1 also includes an electrode delivery port 14, which is used for the ablation electrode 5 to pass through and enter the inner cavity of the puncture needle 31. The tail of the ablation electrode 5 is provided with a pulse connection part 51 for connecting to a pulse generator.

[0060] Specifically, such as Figure 7-11 As shown, the delivery assembly 3 includes a puncture needle 31 with a puncture structure at the distal end; the delivery conduit 2 is provided with a puncture needle channel 21 for the puncture needle 31 to extend out and an image acquisition channel 22 for accommodating the image acquisition device; correspondingly, the main housing 1 is also provided with an image acquisition channel opening 13 for the image acquisition device to extend into the image acquisition channel 22.

[0061] In this embodiment, the proximal end of the puncture needle 31 is fixed relative to the rack 32. Specifically, the rack 32 has an inner cavity, and a rigid tube 36 is fixed in the inner cavity. The proximal end of the puncture needle 31 is located inside the rigid tube 36 and fixedly connected to it. Optionally, the two are fixed with epoxy resin. The rigid tube 36 is preferably a steel tube. The proximal end of the puncture needle 31 is flush with the rigid tube 36 in the rigid tube 36. During the fixation of the puncture needle, the inner tube of the puncture needle is kept unobstructed. When the rack 32 moves back and forth, the rigid tube 36 is always located in the puncture needle channel 21 of the transmission conduit 2 to enhance the pushing force of the puncture needle 31 and prevent the puncture needle from bending and deforming during puncture.

[0062] In this embodiment, the image acquisition device can specifically be an endoscope. The endoscope enters the image acquisition channel 22 through the image acquisition channel opening 13. The endoscope's display screen shows whether it has reached the distal end of the transmission catheter 2. When the endoscope reaches the distal end of the transmission catheter 2, the transmission catheter 2 can be bent by the bending control component 4. By adjusting the bending control component 4, the distal end of the bend is aligned with the tumor location. Specifically, the bending control component 4 includes a pull wire 41 and a bending control element. One end of the pull wire 41 is connected to the bending control element, and the other end is connected to the distal end of the transmission catheter 2. The transmission catheter 2 also includes a pull wire channel 23, through which the pull wire is connected to the distal end of the transmission catheter 2. The bending control element controls the bending angle of the distal end of the delivery component 3 by pulling the pull wire 41. The delivery channel of the ablation device passes through a natural cavity and is combined with the image acquisition channel that houses the image acquisition device, allowing for real-time observation of the distal end. The distal end can be bent and the target area observed by controlling the handle, achieving a complete zero-surface wound. At the same time, the bending function of the distal end increases the flexibility of the product and its wider range of applications.

[0063] Specifically, the bending control component is a bending knob 42, which is rotatably connected to the main housing 1. One end of the pull wire 41 is fixedly connected to the winding portion of the bending knob 42 and is wound around the winding portion of the bending knob 42 by rotating the knob. Rotating the bending knob 42 clockwise causes the distal end of the transmission conduit 2 to bend due to the pull of the pull wire 41, thus adjusting the angle. In other embodiments, the bending knob 42 can also be rotated counterclockwise, causing the distal end of the transmission conduit 2 to bend due to the pull of the pull wire 41. Any design that uses the rotation of the bending knob to control the shortening of the pull wire winding, thereby achieving bending of the transmission conduit, can be used in the product of this embodiment.

[0064] To facilitate the winding of the pull wire, the winding part is provided with a winding groove 421. The inner side of the winding groove 421 is an arc-shaped or sloping transition surface, and a pull wire fixing hole 422 is provided in the winding groove 421. The proximal end of the pull wire 41 is fixed in the pull wire fixing hole 422. When the bending knob 42 is rotated, the pull wire 41 falls into the winding groove 421 along with the rotation of the bending knob 42, which serves to limit and fix the pull wire, while ensuring that the pull wire is smoothly tightened without shaking. The bending knob 42 is also provided with a torsion protrusion 423 for the operator to hold, so that the operator can more easily adjust the rotation of the bending knob 42.

[0065] Using the ablation device in this embodiment specifically includes the following steps:

[0066] During operation, the doctor holds the main housing at the outside, selects the appropriate flexible endoscope, and the endoscope enters the image acquisition channel 22 through the image acquisition channel opening 13. The doctor observes on the endoscope's display screen whether the endoscope has reached the distal end of the transmission catheter 2. When the endoscope reaches the distal end of the transmission catheter 2, the transmission catheter 2 can be bent using the bending control component 4. By adjusting the bending control component 4, the distal end of the bend is aligned with the tumor location. At this time, keeping the main housing 1 in place, the doctor gently presses the drive gear 33 with their thumb. When the drive gear 33 feels loose, the doctor... Figure 3 The drive gear 33 is rotated clockwise from the perspective of the device, causing the puncture needle 31 at the distal end of the delivery catheter 2 to extend and pierce the tissue. After the puncture needle pierces the tissue, the end of the ablation electrode 5 is inserted into the electrode delivery port, passing through the electrode delivery port near the proximal end of the main housing 1. After the ablation electrode 5 is inserted into the target position, the pulse device is controlled to perform discharge ablation.

[0067] In this document, the directional terms such as front, back, top, and bottom are defined according to the positions of the components in the accompanying drawings and the positions between the components, solely for the purpose of clarity and convenience in expressing the technical solution. It should be understood that the use of these directional terms should not limit the scope of protection claimed by this invention.

[0068] Where there is no conflict, the above embodiments and features described herein can be combined with each other.

[0069] The above description is merely a preferred embodiment of the present invention and should not be construed as limiting the scope of the invention. Therefore, any equivalent variations made in accordance with the claims of the present invention are still within the scope of the present invention.

Claims

1. An ablation device with stable delivery function, comprising: Main housing (1), the main housing (1) is connected to a transmission conduit (2) extending to the distal end; Delivery assembly (3), which is at least partially disposed in the main housing (1), is used to deliver the ablation electrode (5) through the delivery conduit (2) to a distal tissue. The delivery assembly (3) is characterized in that it includes a puncture needle (31) with a puncture structure at its distal end, a follower fixedly connected to the puncture needle (31), a drive member for driving the follower, and a biasing member; The drive member is movable relative to the main housing (1) between a locked position and an unlocked position, and the biasing member applies a biasing force toward the locked position to the drive member; The driving member is connected to the driven member in both the locked and unlocked positions, and in the unlocked position, it can drive the movement of the driven member so that the puncture needle (31) extends or retracts into the distal end of the transmission conduit (2), and in the unlocked position, the driving member is restricted from driving the movement of the driven member. The main housing (1) is provided with a first locking member, and the driving member is provided with a second locking member. When the driving member is in the locked position, the first locking member and the second locking member are engaged to restrict the driving member from driving the driven member, but do not restrict the driving member from moving to the unlocked position. The driving component is a driving gear (33). When the first locking component and the second locking component are engaged, the rotation of the driving gear (33) is restricted. The second locking member is a secondary gear (35) located on the side of the drive gear (33), and the first locking member is a locking meshing tooth (11) located on the inner wall of the main housing (1) that matches the secondary gear (35). The biasing component is a curved spring (34), with both ends of the spring (34) fixedly connected to the inner wall of the main housing (1), and the middle part of the spring (34) abutting against the secondary gear (35).

2. The ablation device according to claim 1, characterized in that, The driven member is a rack (32), and when the drive gear (33) is in the locked position and the unlocked position, the drive teeth of the drive gear (33) are at least partially located in the tooth grooves of the rack (32).

3. The ablation device according to claim 1, characterized in that, The main housing (1) is provided with a gear opening (12), and the drive gear (33) is at least partially located outside the gear opening (12) when it is in the locked position.

4. The ablation device according to claim 1, characterized in that, The main housing (1) also includes an electrode delivery port (14), which is used to allow the ablation electrode (5) to pass through and enter the inner cavity of the puncture needle (31).

5. The ablation device according to claim 1, characterized in that, The transmission conduit (2) includes a puncture needle channel (21) for the puncture needle (31) to extend out and an image acquisition channel (22) for accommodating the image acquisition device.

6. The ablation device according to claim 1, characterized in that, The main housing (1) is also provided with an image acquisition channel opening (13) for the image acquisition device to extend into the image acquisition channel (22).

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