Puncture ablation device

Abstract

The present application provides a kind of puncture ablation device, including puncture ablation part, operating part and wiring electrode, it is characterized in that, the puncture ablation part includes the positioning head, ablation electrode needle and outer sheath tube in turn from inside to outside, the wiring electrode is connected with the ablation electrode needle;The ablation electrode needle can be axially moved relative to the outer sheath tube, and the positioning head can be axially moved relative to the ablation electrode needle.The present application is positioned by positioning head into tissue before ablation by ablation electrode needle, so that the spacing of ablation electrode needle and positioning head is fixed in the process of ablation, ablation electrode needle has no relative displacement with lesion, and the purpose of accurate ablation is realized.In the multi-point ablation of larger tumor, ablation is carried out by gradually retreating to multiple ablation points, and multiple-point ablation is located on the same needle path, without secondary CT scanning to determine the ablation point, and the harm of CT ray to human body is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a puncture ablation device. Background Technology

[0002] Although endoscopic ultrasound-guided puncture ablation technology has reached a high level of clinical maturity, the design of its specialized instruments still faces key technical bottlenecks, especially when dealing with tumor lesions with high morphological heterogeneity (such as lobulated or irregularly invasive lesions). These lesions often require sequential ablation of multiple targets via a single puncture path. However, existing conventional ablation electrodes, when dynamically adjusting ablation sites in vivo, are limited by insufficient distal-point directional control and spatial pointing accuracy, easily resulting in significant needle tip deviation. This deviation leads to a non-negligible spatial positioning error between the actual ablation area and the pre-set treatment target area, causing the ablation energy deposition to insufficiently cover the target tumor tissue, ultimately affecting the local complete ablation rate and the certainty of clinical efficacy.

[0003] Meanwhile, the ablation electrode undergoes axial displacement during the puncture path due to respiratory movement, muscle stimulation, or other unpredictable factors, leading to dynamic shifts in the ablation zone. Specifically, when the ablation electrode reaches the target tissue via image-guided navigation and initiates energy release, the chest and abdominal movements induced by the respiratory cycle, muscle stimulation, or other factors cause the needle to reciprocate along the puncture channel, resulting in a significant spatial deviation between the ablation field distribution and the pre-set target area. This mechanical displacement not only reduces the controllability of the ablation range but also easily leads to residual lesions in the target area. Current ablation electrode structures lack displacement compensation mechanisms, becoming a key technical bottleneck restricting precise ablation treatment.

[0004] Please refer to Figure 1 For larger tumors, multiple ablation sessions are generally required. When performing multi-point ablation, the needle needs to be withdrawn or advanced. During this process, the needle may shift, deviating from the intended ablation point, leading to inaccurate or incomplete tumor ablation and failing to achieve the desired effect. To ensure that each ablation occurs along the same needle path, a CT scan is performed before each ablation session to confirm that the ablation point is in the expected location. This increases the risk of radiation exposure to the body. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a puncture ablation device, comprising a puncture ablation section, an operation section, and a wiring electrode. The puncture ablation section includes a positioning head, an ablation electrode needle, and an outer sheath, which are sequentially arranged from the inside out. The wiring electrode is connected to the ablation electrode needle. The ablation electrode needle is axially movable relative to the outer sheath, and the positioning head is axially movable relative to the ablation electrode needle.

[0006] Optionally, before puncture, the positioning head is located inside the ablation electrode needle, and the distal end of the ablation electrode needle is located inside the outer sheath; during puncture, the ablation electrode needle extends from the distal end of the outer sheath and punctures the tissue; after puncture, the positioning head extends from the distal end of the ablation electrode needle and penetrates the tissue for positioning; after positioning, the ablation electrode needle retracts to the ablation point for ablation.

[0007] Optionally, the positioning head includes at least one claw hook. When the positioning head is located inside the ablation electrode needle, the claw hook retracts inside the ablation electrode needle; when the positioning head extends from the distal end of the ablation electrode needle, the claw hook bends outward and unfolds.

[0008] Optionally, the positioning head is a multi-claw needle structure, which includes an integrally formed needle body and at least two claw hooks, with a plurality of claw hooks evenly distributed around the needle body at intervals.

[0009] Optionally, the claw hook is made of stainless steel or nickel-titanium.

[0010] Optionally, the operating unit includes an ablation electrode needle locking mechanism, which is disposed between the proximal end of the outer sheath and the ablation electrode needle, and the ablation electrode needle locking mechanism can controllably restrict the axial movement of the ablation electrode needle relative to the outer sheath.

[0011] Optionally, the ablation electrode needle locking mechanism includes a first locking sleeve and a first locking member. The first locking sleeve is movably sleeved on the ablation electrode needle and fixedly connected to the outer sheath. The first locking member cooperates with the first locking sleeve to restrict the axial movement of the ablation electrode needle relative to the outer sheath.

[0012] Optionally, the first locking member is movably sleeved on the ablation electrode needle, and the first locking sleeve is threadedly connected to the first locking member;

[0013] The ablation electrode needle locking mechanism further includes a first elastic collar, which is movably sleeved on the ablation electrode needle. The first elastic collar is sleeved inside the first locking sleeve and / or the first locking member. When the first locking sleeve and the first locking member are tightened, the first elastic collar is squeezed, thereby locking the ablation electrode needle.

[0014] Optionally, the positioning head extends from the distal end of the ablation electrode needle by being pushed by a push rod;

[0015] The operating unit further includes a push rod locking mechanism, which is disposed between the proximal end of the ablation electrode needle and the push rod. The push rod locking mechanism can controllably restrict the axial movement of the push rod relative to the ablation electrode needle.

[0016] Optionally, the push rod locking mechanism includes a second locking sleeve and a second locking member. The second locking sleeve is movably sleeved on the push rod and fixedly connected to the ablation electrode needle. The second locking member cooperates with the second locking sleeve to restrict the axial movement of the push rod relative to the ablation electrode needle.

[0017] Optionally, the second locking member is movably sleeved on the push rod, and the second locking sleeve is threadedly connected to the second locking member;

[0018] The push rod locking mechanism further includes a second elastic collar, which is movably sleeved on the push rod. The second elastic collar is sleeved inside the second locking sleeve and / or the second locking member. When the second locking sleeve and the second locking member are tightened, the second elastic collar is squeezed, thereby locking the push rod.

[0019] Optionally, the operating unit further includes a handle, and the second locking sleeve is fixedly connected to the ablation electrode needle via the handle.

[0020] Optionally, the positioning head is also fixedly connected to the distal end of the traction wire, the proximal end of the traction wire passing through the distal end of the push rod and exiting from the proximal end of the push rod;

[0021] The operating unit also includes a traction wire locking mechanism, which is disposed between the proximal end of the push rod and the traction wire, and the traction wire locking mechanism can controllably restrict the axial movement of the traction wire relative to the push rod.

[0022] Optionally, the traction wire locking mechanism includes a third locking sleeve and a third locking member. The third locking sleeve is movably sleeved on the traction wire and fixedly connected to the push rod. The third locking member cooperates with the third locking sleeve to restrict the axial movement of the traction wire relative to the push rod.

[0023] Optionally, the third locking member is movably sleeved on the traction wire, and the third locking sleeve is threadedly connected to the third locking member;

[0024] The traction wire locking mechanism further includes a third elastic collar, which is movably sleeved on the traction wire; the third elastic collar is sleeved inside the third locking sleeve and / or the third locking member, and when the third locking sleeve and the third locking member are tightened, the third elastic collar is squeezed, thereby locking the traction wire.

[0025] Optionally, the operating part further includes a pull cap disposed at the proximal end of the traction wire.

[0026] Optionally, a push tube is provided between the positioning head and the push rod, the push tube is sleeved on the traction wire, and the push tube is fixedly connected to the push rod.

[0027] Optionally, the ablation electrode needle includes an integrally formed ablation part and a main body part, the ablation part being located at the head end of the main body part, and the outer periphery of the main body part being provided with a first insulating structure.

[0028] Compared with the prior art, the technical solution of the embodiments of the present invention has the following beneficial effects:

[0029] This invention provides a puncture ablation device, including a puncture ablation section, an operating section, and a connecting electrode. The puncture ablation section includes a positioning head, an ablation electrode needle, and an outer sheath, sequentially arranged from the inside out. The connecting electrode is connected to the ablation electrode needle. The ablation electrode needle is axially movable relative to the outer sheath, and the positioning head is axially movable relative to the ablation electrode needle. Before ablation is performed using the ablation electrode needle, the positioning head is inserted into the tissue for positioning, ensuring a fixed distance between the ablation electrode needle and the positioning head during ablation. This achieves no relative displacement between the ablation electrode needle and the lesion, thereby achieving precise ablation.

[0030] Since the positioning head has been inserted into the tissue for positioning, when performing multi-point ablation on larger tumors, the ablation can be performed by gradually retreating to multiple ablation points. Therefore, multi-point ablation can be carried out on the same needle path, eliminating the need for a second CT scan to determine the ablation point. This ensures the accuracy of ablation and reduces the harm of CT radiation to the human body. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of multi-point ablation using a conventional ablation electrode needle;

[0033] Figure 2 This is a schematic diagram of the puncture ablation device provided in an embodiment of the present invention;

[0034] Figure 3 This is a schematic diagram of multi-point ablation using a puncture ablation device provided in an embodiment of the present invention;

[0035] Figure 4 This is a schematic diagram of the initial state of the puncture ablation device provided in an embodiment of the present invention;

[0036] Figure 5 This is a schematic diagram of the structure of the ablation electrode needle when it is extended during puncture, according to an embodiment of the present invention;

[0037] Figure 6 This is a schematic diagram of the structure when the positioning head is extended for positioning according to an embodiment of the present invention;

[0038] Figure 7 This is a schematic diagram of the structure of the ablation electrode needle during retraction ablation according to an embodiment of the present invention;

[0039] Figure 8 An exploded view of a puncture ablation device provided in an embodiment of the present invention;

[0040] Figure 9 This is a schematic diagram of the distal end of the puncture ablation device in its initial state according to an embodiment of the present invention.

[0041] Figure 10 This is an exploded view of an ablation electrode needle locking mechanism provided in an embodiment of the present invention;

[0042] Figure 11 This is a cross-sectional view of an ablation electrode needle locking mechanism provided in an embodiment of the present invention;

[0043] Figure 12 An exploded view of a push rod locking mechanism provided in an embodiment of the present invention;

[0044] Figure 13 A cross-sectional view of a push rod locking mechanism provided in an embodiment of the present invention;

[0045] Figure 14 This is an exploded view of a traction wire locking mechanism provided in an embodiment of the present invention;

[0046] Figure 15 This is a cross-sectional view of a traction wire locking mechanism provided in an embodiment of the present invention;

[0047] Figure 16 This is a schematic diagram of the positioning head provided in an embodiment of the present invention. Detailed Implementation

[0048] 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. 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.

[0049] The terms "first," "second," "third," "fourth," etc. (if present) in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus. The terms "above" and "over," and any variations thereof, are intended to describe positional relationships and do not imply direct contact between the described objects.

[0050] Please refer to Figures 2 to 16 An embodiment of the present invention provides a puncture ablation device, including a puncture ablation part, an operation part, and a wiring electrode 12. The puncture ablation part includes a positioning head 4, an ablation electrode needle 2, and an outer sheath 3, which are sequentially sleeved from the inside to the outside. The wiring electrode 12 is connected to the ablation electrode needle 2. The ablation electrode needle 2 is axially movable relative to the outer sheath 3, and the positioning head 4 is axially movable relative to the ablation electrode needle 2.

[0051] In this embodiment, before ablation is performed by the ablation electrode needle 2, the positioning head 4 is inserted into the tissue for positioning, so that the distance between the ablation electrode needle 2 and the positioning head 4 is fixed during the ablation process, thereby achieving no relative displacement between the ablation electrode needle 2 and the lesion, and thus achieving the purpose of precise ablation.

[0052] Since the positioning head 4 has been inserted into the tissue for positioning, when performing multi-point ablation on larger tumors, the ablation electrode needle 2 is gradually withdrawn to multiple ablation points for ablation. Therefore, multi-point ablation can be carried out on the same needle path without the need for a second CT scan to determine the ablation point. This ensures the accuracy of ablation and reduces the harm of CT radiation to the human body.

[0053] In this embodiment, the operating part can be controlled such that: the ablation electrode needle 2 can move axially relative to the outer sheath tube 3, and the positioning head 4 can move axially relative to the ablation electrode needle 2.

[0054] Specifically, before puncture, the positioning head 4 is located inside the ablation electrode needle 2, and the distal end of the ablation electrode needle 2 is located inside the outer sheath 3.

[0055] During the puncture, the ablation electrode needle 2 extends from the distal end of the outer sheath 3 and punctures the tissue. Please refer to [reference needed]. Figure 2The leftmost image.

[0056] After the puncture is completed, the positioning head 4 extends from the distal end of the ablation electrode needle 2 and penetrates the tissue for positioning. Please refer to [reference needed]. Figure 2 The image in the center shows the ablation electrode needle 2 penetrating deep into the tissue, while the positioning head 4 penetrates the tissue to its outer side, achieving positioning by hooking onto the outer wall of the tissue. Of course, the positioning head 4 doesn't necessarily have to be located on the outer side of the tissue; it can also be located inside the tissue, achieving positioning by hooking onto the tissue interior.

[0057] After positioning, the ablation electrode needle 2 is retracted to the ablation point for ablation. Please refer to [the relevant documentation]. Figure 2 The rightmost image in the middle.

[0058] In this embodiment, the head end of the outer sheath tube 3 is rounded, which can effectively reduce damage to the natural cavity during the process of inserting it into the human body's natural cavity.

[0059] The outer sheath 3 has good pushing performance and can be smoothly pushed into the working channel of the endoscope.

[0060] Both the outer sheath 3 and the distal end of the ablation electrode needle 2 have good flexibility, allowing them to conform to various bends in natural cavities and reach the target location.

[0061] The outer sheath 3 is a polymer catheter, including but not limited to PEEK, PTFE, PA, etc.

[0062] In this embodiment, the operating unit includes an ablation electrode needle locking mechanism 6. The proximal end of the ablation electrode needle 2 extends from the proximal end of the outer sheath 3. The ablation electrode needle locking mechanism 6 is disposed between the proximal end of the outer sheath 3 and the ablation electrode needle 2. The ablation electrode needle locking mechanism 6 can controllably restrict the axial movement of the ablation electrode needle 2 relative to the outer sheath 3. When the ablation electrode needle locking mechanism 6 is in an unlocked state, the ablation electrode needle 2 can move axially relative to the outer sheath 3; when the ablation electrode needle locking mechanism 6 is in a locked state, the ablation electrode needle 2 is fixed relative to the outer sheath 3.

[0063] This embodiment does not limit the specific structure of the ablation electrode needle locking mechanism 6. Any structure that can achieve the purpose of "when the ablation electrode needle locking mechanism 6 is not locked, the ablation electrode needle 2 can move axially relative to the outer sheath tube 3; when the ablation electrode needle locking mechanism 6 is locked, the ablation electrode needle 2 is fixed relative to the outer sheath tube 3" is within the protection scope of this embodiment.

[0064] In one embodiment, the ablation electrode needle locking mechanism 6 includes a first locking sleeve 601 and a first locking member 603. The first locking sleeve 601 is movably sleeved on the ablation electrode needle 2 and fixedly connected to the outer sheath tube 3. The first locking member 603 cooperates with the first locking sleeve 601 to restrict the axial movement of the ablation electrode needle 2 relative to the outer sheath tube 3. That is, the first locking sleeve 601, through cooperation with the first locking member 603, allows the ablation electrode needle 2 to be fixed or axially movable relative to the outer sheath tube 3.

[0065] This embodiment does not limit the specific structure of the first locking member 603. For example, a locking screw can be inserted into the first locking sleeve 601 to fix the ablation electrode needle 2 relative to the outer sheath tube 3 by squeezing the ablation electrode needle 2. By disengaging from the ablation electrode needle 2, the ablation electrode needle 2 can be moved axially relative to the outer sheath tube 3.

[0066] The first locking member 603 can also be a nut, threadedly engaged with the first locking sleeve 601 to lock and unlock the ablation electrode needle 2. Specifically, the first locking member 603 is movably sleeved on the ablation electrode needle 2, and the first locking sleeve 601 is threadedly connected to the first locking member 603.

[0067] The ablation electrode needle locking mechanism 6 further includes a first elastic collar 602, which is movably sleeved on the ablation electrode needle 2. The first elastic collar 602 is fitted inside the first locking sleeve 601 and / or the first locking member 603. When the first locking sleeve 601 and the first locking member 603 are tightened, the first elastic collar 602 is compressed, causing the first elastic collar 602 to hold the ablation electrode needle 2 tightly, thus fixing the first elastic collar 602 relative to the ablation electrode needle 2. When the first locking sleeve 601 and the first locking member 603 are not tightened and the first elastic collar 602 is not compressed, the ablation electrode needle 2 can move axially relative to the outer sheath 3.

[0068] In this embodiment, the first elastic collar 602 can be fitted inside the first locking sleeve 601, or inside the first locking member 603, or inside both the first locking sleeve 601 and the first locking member 603 respectively. This embodiment does not limit this.

[0069] like Figure 10 and 11 As shown, the side of the first locking sleeve 601 facing the first locking member 603 is a double-layered collar, which includes an inner collar and an outer collar. The inner collar is movably fitted onto the ablation electrode needle 2. The inner wall of the outer collar is provided with a first internal thread 60101.

[0070] The first locking member 603 has a single-layer collar on the side facing the first locking sleeve 601. The outer wall of the collar is provided with a first external thread 60301 that is adapted to the first internal thread 60101. The first elastic collar 602 is located inside the single-layer collar of the first locking member 603.

[0071] As the single-layer collar of the first locking member 603 is continuously screwed into the inner and outer collars of the first locking sleeve 601, the first locking member 603 will continuously squeeze the first elastic collar 602 until the ablation electrode needle 2 can no longer move axially relative to the outer sheath tube 3.

[0072] Since the first locking sleeve 601 of the outer sheath 3 needs to be connected to the biopsy cap of the endoscope after the endoscope is inserted into the outer sheath 3, the structure of the first locking sleeve 601 also needs to be adapted to the biopsy cap of the endoscope. Because biopsy caps of different endoscopes may differ, this embodiment does not limit the specific structure of the part of the first locking sleeve 601 that connects to the biopsy cap, and can be set according to actual usage requirements. For example, the first locking sleeve 601 can be a circular plug, and the first locking member 603 can be a Luer plug.

[0073] In this embodiment, the positioning head 4 extends from the distal end of the ablation electrode needle 2 by being pushed by the push rod 9.

[0074] The operating unit further includes a push rod locking mechanism 8, which is disposed between the proximal end of the ablation electrode needle 2 and the push rod 9. The push rod locking mechanism 8 can controllably restrict the axial movement of the push rod 9 relative to the ablation electrode needle 2. In this embodiment, when the push rod locking mechanism 8 is in an unlocked state, the push rod 9 can move axially relative to the ablation electrode needle 2; when the push rod locking mechanism 8 is in a locked state, the push rod 9 is fixed relative to the ablation electrode needle 2.

[0075] This embodiment does not limit the specific structure of the push rod locking mechanism 8. Any mechanism that can achieve the purpose of "when the push rod locking mechanism 8 is in the unlocked state, the push rod 9 can move axially relative to the ablation electrode needle 2; when the push rod locking mechanism 8 is in the locked state, the push rod 9 is fixed relative to the ablation electrode needle 2" is within the protection scope of this embodiment.

[0076] In one embodiment, the push rod locking mechanism 8 includes a second locking sleeve 801 and a second locking member 803. The second locking sleeve 801 is movably sleeved on the push rod 9 and fixedly connected to the ablation electrode needle 2. The second locking member 803 cooperates with the second locking sleeve 801 to restrict the axial movement of the push rod 9 relative to the ablation electrode needle 2. That is, the second locking sleeve 801, through cooperation with the second locking member 803, allows the push rod 9 to be fixed or axially movable relative to the ablation electrode needle 2.

[0077] This embodiment does not limit the specific structure of the second locking member 803. For example, a locking screw can be inserted into the second locking sleeve 801, and the push rod 9 can be fixed relative to the ablation electrode needle 2 by squeezing the push rod 9. By disengaging from the push rod 9, the push rod 9 can move axially relative to the ablation electrode needle 2.

[0078] The second locking element 803 can also be a nut, threadedly engaging with the second locking sleeve 801 to lock and unlock the push rod 9. Specifically, the second locking element 803 is movably sleeved on the push rod 9, and the second locking sleeve 801 is threadedly connected to the second locking element 803.

[0079] The push rod locking mechanism 8 further includes a second elastic collar 802, which is movably sleeved on the push rod 9. The second elastic collar 802 is fitted inside the second locking sleeve 801 and / or the second locking member 803. When the second locking sleeve 801 and the second locking member 803 are tightened, they compress the second elastic collar 802, causing the second elastic collar 802 to grip the push rod 9, thus fixing the second elastic collar 802 relative to the push rod 9. When the second locking sleeve 801 and the second locking member 803 are not tightened and compressing the second elastic collar 802, the push rod 9 can move axially relative to the ablation electrode needle 2.

[0080] In this embodiment, the second elastic collar 802 can be fitted inside the second locking sleeve 801, or inside the second locking member 803, or inside both the second locking sleeve 801 and the second locking member 803 respectively. This embodiment does not limit this.

[0081] like Figure 13 As shown, the second elastic collar 802 is fitted inside the second locking member 803. The inner ring of the second locking sleeve 801 facing the second locking member 803 is provided with a second internal thread 80101. The outer ring of the second locking member 803 facing the second locking sleeve 801 is provided with a second external thread 80301 that matches the second internal thread 80101. As the second external thread 80301 is continuously screwed into the second internal thread 80101, the second locking member 803 will continuously squeeze the second elastic collar 802 until the push rod 9 can no longer move axially relative to the ablation electrode needle 2.

[0082] The second locking sleeve 801 can be directly or indirectly fixedly connected to the ablation electrode needle 2. This embodiment does not impose any restrictions on this.

[0083] In one embodiment, the operating part further includes a handle 7, and the second locking sleeve 801 is fixedly connected to the ablation electrode needle 2 via the handle 7.

[0084] This embodiment does not limit the connection position between the wiring electrode 12 and the ablation electrode needle 2, and can be set according to the needs of the actual structure. In one implementation, the wiring electrode 12 passes through the handle 7 and connects to the ablation electrode needle 2. During ablation, the wiring electrode 12 is connected to the main unit.

[0085] In this embodiment, the ablation electrode needle 2 is a tubular structure, comprising an integrally formed ablation part and a main body. The ablation part is located at the head end of the main body, and the wiring electrode 12 is connected to the main body. A first insulating structure 15 is provided on the outer periphery of the main body. This embodiment does not limit the specific structure of the first insulating structure 15; it can be applied to the main body as a coating, or it can be fixedly sleeved onto the main body as an insulating tube. The fixing method can be heat shrinking, adhesive bonding, heat fusion, etc. During the process of pulsed electric field energy being transferred from the host to the ablation electrode needle 2, the first insulating structure 15 can prevent leakage current and energy loss, generating a pulsed electric field only in the ablation part, achieving precise ablation.

[0086] The ablation electrode needle 2 is made of materials including, but not limited to, stainless steel and nickel-titanium.

[0087] Preferably, the distal end of the ablation electrode needle 2 has a curved section, such as the design of a hypotube that can be achieved by laser cutting, which can easily achieve bending under endoscopy.

[0088] The tip of the ablation electrode needle 2 has a needle point to facilitate puncture.

[0089] The ablation part of the ablation electrode needle 2 has an ultrasonic imaging structure for ultrasonic imaging. The ultrasonic imaging structure includes, but is not limited to, annular grooves, dot-shaped structures, triangular structures, etc.

[0090] In this embodiment, the positioning head 4 is also fixedly connected to the distal end of the traction wire 5, and the proximal end of the traction wire 5 passes through the distal end of the push rod 9 and exits from the proximal end of the push rod 9.

[0091] The operating unit further includes a traction wire locking mechanism 10, which is disposed between the proximal end of the push rod 9 and the traction wire 5. The traction wire locking mechanism 10 can controllably restrict the axial movement of the traction wire 5 relative to the push rod 9. In this embodiment, when the traction wire locking mechanism 10 is in an unlocked state, the traction wire 5 can move axially relative to the push rod 9; when the traction wire locking mechanism 10 is in a locked state, the traction wire 5 is fixed relative to the push rod 9.

[0092] This embodiment does not limit the specific structure of the traction wire locking mechanism 10. Any structure that can achieve the purpose of "when the traction wire locking mechanism 10 is in an unlocked state, the traction wire 5 can move axially relative to the push rod 9; when the traction wire locking mechanism 10 is in a locked state, the traction wire 5 is fixed relative to the push rod 9" is within the protection scope of this embodiment.

[0093] In one embodiment, the traction wire locking mechanism 10 includes a third locking sleeve 1001 and a third locking member 1003. The third locking sleeve 1001 is movably sleeved on the traction wire 5 and fixedly connected to the push rod 9. The third locking member 1002 cooperates with the third locking sleeve 1001 to restrict the axial movement of the traction wire 5 relative to the push rod 9. That is, the third locking sleeve 1001, through cooperation with the third locking member 1003, allows the traction wire 5 to be fixed or axially movable relative to the push rod 9.

[0094] This embodiment does not limit the specific structure of the third locking member 1003. For example, a locking screw can be inserted into the third locking sleeve 1001, and the traction wire 5 can be fixed relative to the push rod 9 by squeezing the traction wire 5. By disengaging from the traction wire 5, the traction wire 5 can move axially relative to the push rod 9.

[0095] The third locking element 1003 can also be a nut, threadedly engaged with the third locking sleeve 1001 to lock and unlock the traction wire 5. Specifically, the third locking element 1003 is movably sleeved on the traction wire 5, and the third locking sleeve 1001 is threadedly connected to the third locking element 1003.

[0096] The traction wire locking mechanism 10 further includes a third elastic collar 1002, which is movably sleeved on the traction wire 5. The third elastic collar 1002 is fitted inside the third locking sleeve 1001 and / or the third locking member 1003. When the third locking sleeve 1001 and the third locking member 1003 are tightened, the third elastic collar 1002 is compressed, thus fixing the third elastic collar 1002 relative to the traction wire 5. When the third locking sleeve 1001 and the third locking member 1003 are not tightened and the third elastic collar 1002 is not compressed, the traction wire 5 can move axially relative to the push rod 9.

[0097] In this embodiment, the third elastic collar 1002 can be fitted inside the third locking sleeve 1001, or inside the third locking member 1003, or inside both the third locking sleeve 1001 and the third locking member 1003 respectively. This embodiment does not limit this.

[0098] like Figure 15As shown, the third elastic collar 1002 is fitted inside the third locking sleeve 1001. The outer ring of the third locking sleeve 1001 is provided with a third external thread 1001. The inner ring of the third locking member 1003 is provided with a third internal thread that matches the third external thread 1001. As the third internal thread is continuously screwed into the third external thread 1001, the third locking sleeve 1001 will continuously squeeze the third elastic collar 1002 until the traction wire 5 can no longer move axially relative to the push rod 9.

[0099] To facilitate tightening of the traction wire 5, the operating part also includes a pull cap 11, which is disposed near the proximal end of the traction wire 5. This embodiment does not limit the specific structure of the pull cap 11, as long as it is convenient for manual operation. This embodiment does not limit the connection method between the pull cap 11 and the traction wire 5, including but not limited to bonding with AB epoxy glue, UV glue, etc.

[0100] The outer periphery of the traction wire 5 is provided with a second insulating structure 13. In this embodiment, the specific structure of the second insulating structure 13 is not limited. It can be coated on the outer periphery of the traction wire 5 by means of a coating, or it can be fixedly sleeved on the traction wire 5 by means of an insulating tube. The fixing method can be heat melting, bonding, etc.

[0101] Preferably, the traction wire 5 is a rigid drawn wire, including but not limited to stainless steel rope, nickel-titanium wire, etc.

[0102] During the process of pushing the positioning head 4 to extend from the distal end of the ablation electrode needle 2, the push rod 9 can directly or indirectly contact the positioning head 4; this embodiment does not impose specific limitations on this. In the technical solution where the push rod 9 directly contacts the positioning head 4, there is no fixed connection between the push rod 9 and the positioning head 4; that is, the push rod 9 and the positioning head 4 can be separated.

[0103] In the technical solution where the push rod 9 indirectly contacts the positioning head 4, specifically, a push tube 14 is provided between the positioning head 4 and the push rod 9. The push tube 14 is sleeved on the traction wire 5 and is fixedly connected to the push rod 9. In this embodiment, the proximal end of the push tube 14 is fixedly connected to the push rod 9, while the distal end of the push rod 9 is not fixedly connected to the positioning head 4; that is, the push rod 9 and the positioning head 4 can be separated.

[0104] Furthermore, the distal end of the push rod 9 is provided with a push rod head 16, which is located inside the handle 7 and is fixedly connected to the push tube 14.

[0105] This embodiment does not impose specific restrictions on the structure of the positioning head 4, as long as it can hook onto the tissue for positioning. For example, a claw hook structure or an arrow structure can be used.

[0106] As one embodiment, the positioning head 4 includes at least one claw hook 402. When the positioning head 4 is located inside the ablation electrode needle 2, the claw hook 402 is retracted inside the ablation electrode needle 2. When the positioning head 4 extends from the distal end of the ablation electrode needle 2, the claw hook 402 bends outward and unfolds.

[0107] To facilitate more stable hooking of tissue for positioning, preferably, the positioning head 4 includes at least two claw hooks 402, the distal ends of which are fixed together.

[0108] For details, please refer to Figure 16 The positioning head 4 is a multi-claw needle structure, which includes a needle body 401 and several claw hooks 402. Several claw hooks 402 are uniformly spaced and integrally arranged around the distal end of the needle body 401. The proximal end of the needle body 401 is fixedly connected to the distal end of the traction wire 5. The fixing methods of the needle body 401 and the traction wire 5 include, but are not limited to, welding, crimping, etc.

[0109] This embodiment does not impose specific restrictions on the processing technology of the claw hook 402. For example, it can be formed by cutting the distal end of the needle body 401.

[0110] This embodiment does not impose specific limitations on the material of the claw hook 402, as long as it can ensure that "when the positioning head 4 is located inside the ablation electrode needle 2, the claw hook 402 retracts into the ablation electrode needle 2; when the positioning head 4 extends from the distal end of the ablation electrode needle 2, the claw hook 402 bends outward and unfolds." Materials with this characteristic include shape memory alloys, stainless steel, and nickel-titanium alloys.

[0111] The working principle of the puncture ablation device provided in this embodiment:

[0112] Please refer to Figure 4 The initial state of the puncture ablation device is as follows: the positioning head 4 is located inside the ablation electrode needle 2, the distal end of the ablation electrode needle 2 is located inside the outer sheath 3, and the ablation electrode needle locking mechanism 6, the push rod locking mechanism 8, and the traction wire locking mechanism 10 are all in a locked state. After the endoscope is inserted into the outer sheath 3, the first locking sleeve 601 of the outer sheath 3 is connected to the biopsy cap of the endoscope, and the endoscope is manipulated to reach the puncture point. The specific operation of the puncture ablation device is as follows:

[0113] First, the ablation electrode needle locking mechanism 6 is in the unlocked state to ensure that the ablation electrode needle 2 can move axially relative to the outer sheath 3. Then, the push rod locking mechanism 8 and the traction wire locking mechanism 10 are locked to ensure that the positioning head 4 and the ablation electrode needle 2 can move synchronously. Please refer to [reference needed]. Figure 4 .

[0114] Then, push the handle 7 forward, causing it to extend the ablation electrode needle 2 from the distal end of the outer sheath 3 for puncture. Please refer to... Figure 5 ;

[0115] After the puncture is completed, the ablation electrode needle locking mechanism 6 is locked to ensure that the ablation electrode needle 2 is fixed relative to the outer sheath 3; and the push rod locking mechanism 8 is unlocked to ensure that the push rod 9 can move axially relative to the ablation electrode needle 2.

[0116] Next, push the push rod 9 to extend the positioning head 4 from the distal end of the ablation electrode needle 2 and insert it into the tissue for precise positioning. Please refer to [link / reference needed]. Figure 6 ;

[0117] After positioning is completed, the push rod locking mechanism 8 is locked to ensure that the push rod 9 can be fixed relative to the ablation electrode needle 2. At the same time, the ablation electrode needle locking mechanism 6 and the traction wire locking mechanism 10 are both unlocked to ensure that the ablation electrode needle 2 can move axially relative to the outer sheath tube 3 and the traction wire 5 can move axially relative to the push rod 9.

[0118] Next, push the handle 7 backward. At this time, the positioning head 4 remains stationary, the traction wire 5 moves forward relative to the handle 7, and the ablation electrode needle 2 moves backward with the handle 7. After reaching the ablation point, the push rod locking mechanism 8 is locked. At this time, the traction wire 5 is taut. Please refer to [the relevant documentation]. Figure 7 ;

[0119] Next, connect the wiring electrode 12 to the main unit and start the energy ablation process.

[0120] When performing multi-point ablation on a large tumor, the ablation electrode needle 2 is moved backward along with the handle 7 to reach multiple ablation points for ablation.

[0121] In this embodiment, before ablation is performed by the ablation electrode needle 2, the positioning head 4 is inserted into the tissue for positioning, so that the distance between the ablation electrode needle 2 and the positioning head 4 is fixed during the ablation process, thereby achieving no relative displacement between the ablation electrode needle 2 and the lesion, and thus achieving the purpose of precise ablation.

[0122] Since the positioning head 4 has been inserted into the tissue for positioning, when performing multi-point ablation on larger tumors, multiple ablation points can be located on the same needle path, eliminating the need for a second CT scan to determine the ablation point. This ensures the accuracy of ablation and reduces the harm of CT radiation to the human body.

[0123] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A puncture ablation device, comprising a puncture ablation section, an operating section, and a wiring electrode, characterized in that, The puncture ablation unit includes a positioning head, an ablation electrode needle, and an outer sheath, which are sequentially arranged from the inside out. The wiring electrode is connected to the ablation electrode needle. The ablation electrode needle is axially movable relative to the outer sheath, and the positioning head is axially movable relative to the ablation electrode needle. Before puncture, the positioning head is located inside the ablation electrode needle, and the distal end of the ablation electrode needle is located inside the outer sheath. During puncture, the ablation electrode needle extends from the distal end of the outer sheath and punctures the tissue. After puncture, the positioning head extends from the distal end of the ablation electrode needle and penetrates the tissue for positioning. After positioning, the ablation electrode needle retracts to the ablation point for ablation.

2. The puncture ablation device according to claim 1, characterized in that, The positioning head includes at least one claw hook. When the positioning head is located inside the ablation electrode needle, the claw hook retracts into the ablation electrode needle. When the positioning head extends from the distal end of the ablation electrode needle, the claw hook bends outward and unfolds.

3. The puncture ablation device according to claim 2, characterized in that, The positioning head is a multi-claw needle structure, which includes an integrally formed needle body and at least two claw hooks, with a plurality of claw hooks evenly distributed around the needle body at intervals.

4. The puncture ablation device according to claim 2, characterized in that, The claw hook is made of stainless steel or nickel-titanium.

5. The puncture ablation device according to claim 1, characterized in that, The operating unit includes an ablation electrode needle locking mechanism, which is disposed between the proximal end of the outer sheath and the ablation electrode needle. The ablation electrode needle locking mechanism can controllably restrict the axial movement of the ablation electrode needle relative to the outer sheath.

6. The puncture ablation device according to claim 5, characterized in that, The ablation electrode needle locking mechanism includes a first locking sleeve and a first locking member. The first locking sleeve is movably sleeved on the ablation electrode needle and fixedly connected to the outer sheath. The first locking member cooperates with the first locking sleeve to restrict the axial movement of the ablation electrode needle relative to the outer sheath.

7. The puncture ablation device according to claim 6, characterized in that, The first locking element is movably sleeved on the ablation electrode needle, and the first locking sleeve is threadedly connected to the first locking element. The ablation electrode needle locking mechanism further includes a first elastic collar, which is movably sleeved on the ablation electrode needle. The first elastic collar is sleeved inside the first locking sleeve and / or the first locking member. When the first locking sleeve and the first locking member are tightened, the first elastic collar is squeezed, thereby locking the ablation electrode needle.

8. The puncture ablation device according to claim 1, characterized in that, The positioning head extends from the distal end of the ablation electrode needle by being pushed by a push rod; The operating unit further includes a push rod locking mechanism, which is disposed between the proximal end of the ablation electrode needle and the push rod. The push rod locking mechanism can controllably restrict the axial movement of the push rod relative to the ablation electrode needle.

9. The puncture ablation device according to claim 8, characterized in that, The push rod locking mechanism includes a second locking sleeve and a second locking member. The second locking sleeve is movably sleeved on the push rod and fixedly connected to the ablation electrode needle. The second locking member cooperates with the second locking sleeve to restrict the axial movement of the push rod relative to the ablation electrode needle.

10. The puncture ablation device according to claim 9, characterized in that, The second locking element is movably sleeved on the push rod, and the second locking sleeve is threadedly connected to the second locking element; The push rod locking mechanism further includes a second elastic collar, which is movably sleeved on the push rod. The second elastic collar is sleeved inside the second locking sleeve and / or the second locking member. When the second locking sleeve and the second locking member are tightened, the second elastic collar is squeezed, thereby locking the push rod.

11. The puncture ablation device according to claim 9, characterized in that, The operating unit also includes a handle, and the second locking sleeve is fixedly connected to the ablation electrode needle via the handle.

12. The puncture ablation device according to claim 9, characterized in that, The positioning head is also fixedly connected to the distal end of the traction wire, the proximal end of which enters from the distal end of the push rod and exits from the proximal end of the push rod. The operating unit also includes a traction wire locking mechanism, which is disposed between the proximal end of the push rod and the traction wire, and the traction wire locking mechanism can controllably restrict the axial movement of the traction wire relative to the push rod.

13. The puncture ablation device according to claim 12, characterized in that, The traction wire locking mechanism includes a third locking sleeve and a third locking member. The third locking sleeve is movably sleeved on the traction wire and fixedly connected to the push rod. The third locking member cooperates with the third locking sleeve to restrict the axial movement of the traction wire relative to the push rod.

14. The puncture ablation device according to claim 13, characterized in that, The third locking element is movably sleeved on the traction wire, and the third locking sleeve is threadedly connected to the third locking element; The traction wire locking mechanism further includes a third elastic collar, which is movably sleeved on the traction wire; the third elastic collar is sleeved inside the third locking sleeve and / or the third locking member, and when the third locking sleeve and the third locking member are tightened, the third elastic collar is squeezed, thereby locking the traction wire.

15. The puncture ablation device according to claim 14, characterized in that, The operating part also includes a pull cap, which is disposed near the end of the traction wire.

16. The puncture ablation device according to claim 14, characterized in that, A push tube is also provided between the positioning head and the push rod. The push tube is sleeved on the traction wire and is fixedly connected to the push rod.

17. The puncture ablation device according to claim 1, characterized in that, The ablation electrode needle includes an integrally formed ablation part and a main body part. The ablation part is located at the head end of the main body part, and a first insulating structure is provided on the outer periphery of the main body part.

Images