Ablation device and medical equipment
By setting electrically isolated electrodes on the needle core of the ablation device and applying electrical signals after biopsy sampling is completed, thermal ablation of tumor tissue is achieved, solving the problems of bleeding after puncture and metastasis of lesion tissue, and improving the safety and effectiveness of treatment.
Patent Information
- Application Number
- CN202421062572.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-15
- Publication Date
- 2025-03-28
- Estimated Expiration
- 2034-05-15
AI Technical Summary
In imaging-guided interventional treatment of tumor puncture and radiofrequency ablation, biopsy needles are prone to bleeding when extracted, and the lesion tissue may metastasize, which is difficult for the prior art to effectively solve these problems.
An ablation device is designed, including a needle core and an outer cannula, and an electrically isolated first electrode and a second electrode are provided on the needle core. After the biopsy sampling is completed, thermal ablation of the tissue to be ablated is achieved by applying an electrical signal to these electrodes, and the lesion tissue attached to the needle core is eliminated, and the needle canal transfer is prevented while hemostasis is achieved.
Effectively stop bleeding, eliminate lesion tissue attached to the needle core, and prevent needle tract metastasis, improving the safety and effectiveness of treatment.
Smart Images
Figure CN222676425U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical equipment, in particular to an ablation device and medical equipment. Background Art
[0002] With the continuous development of medical technology, the application of tumor puncture and radiofrequency ablation interventional treatment under image guidance is becoming more and more widespread.
[0003] At present, the most commonly used treatment method in clinical practice is mainly to use coaxial biopsy puncture needles and needle cores in steps. After the biopsy puncture needle completes the biopsy sampling, the puncture needle tract is prone to bleeding when it is pulled out, and the diseased tissue may metastasize. Therefore, it is necessary to design an ablation device that can both stop bleeding and prevent needle tract metastasis. Utility Model Content
[0004] The utility model provides an ablation device and medical equipment, which are used to stop bleeding and ablate the needle tract after the biopsy sampling is completed, and eliminate the diseased tissue attached to the needle core and the outer sleeve.
[0005] According to one aspect of the present invention, there is provided an ablation device, comprising:
[0006] The needle core comprises a main body, a first insulating layer, a first electrode and a second electrode; the first electrode, the first insulating layer and the second electrode are sequentially sleeved outside the main body along the extension direction of the main body, and the first electrode and the second electrode are electrically isolated by the first insulating layer.
[0007] Optionally, the main body and the first electrode are an integrated structure;
[0008] The needle core further includes: a second insulating layer, which is arranged between the main body and the second electrode, and the second electrode and the main body are electrically isolated by the second insulating layer.
[0009] Optionally, part of the second insulating layer is located between the second electrode and the main body, and the rest of the second insulating layer is located between the first insulating layer and the main body.
[0010] Optionally, the ablation device further comprises:
[0011] The outer sleeve, in the needle insertion state and / or the ablation state, the needle core is configured to be sleeved in the outer sleeve, and when the needle core is sleeved in the outer sleeve, the end of the outer sleeve exposes at least a portion of the second electrode.
[0012] Optionally, the ablation device further comprises an outer sleeve, and in the needle insertion state and / or the ablation state, the needle core is configured to be sleeved in the outer sleeve;
[0013] The outer sleeve comprises: a third electrode and a third insulating layer;
[0014] The third insulating layer is disposed on the outer surface of the third electrode and exposes the end of the third electrode, and the third electrode is a tubular structure;
[0015] When the needle core is sleeved in the outer sleeve, the third electrode contacts the second electrode and at least the first electrode is exposed, and the first electrode is electrically insulated from the third electrode.
[0016] Optionally, the ablation device further comprises: a needle core handle, wherein the needle core handle is fixedly connected to the needle core;
[0017] The ablation device also includes an outer sleeve seat, which is fixedly connected to the outer sleeve;
[0018] The needle core handle and the outer sleeve seat are detachably connected, and the needle core handle and the outer sleeve seat are configured to set the needle core in the outer sleeve when connected.
[0019] Optionally, a portion of the outer surface of the first electrode parallel to the main body, an outer surface of the first insulating layer, and an outer surface of the second electrode are all flush.
[0020] According to another aspect of the present invention, a medical device is provided, comprising any one of the ablation devices described above.
[0021] Optionally, the medical device further comprises:
[0022] an energy generator, the energy generator being electrically connected to the first electrode and the second electrode respectively;
[0023] The energy generator is used to output a first electrical signal to the first electrode and a second electrical signal to the second electrode in an ablation state, wherein the first electrical signal and the second electrical signal are both sinusoidal electrical signals, or the first electrical signal and the second electrical signal are both pulse electrical signals.
[0024] Optionally, the ablation device comprises an outer sleeve;
[0025] The medical device further comprises: a biopsy puncture needle, wherein the biopsy puncture needle is configured to be sheathed in the outer sleeve for tissue sampling in a biopsy state; the needle core is configured to be independent of the outer sleeve in the biopsy state;
[0026] Furthermore, the biopsy puncture needle is configured to be independent of the outer sleeve in a needle insertion state and / or an ablation state.
[0027] In the embodiment of the utility model, by arranging an electrically isolated first electrode and a second electrode on the needle core, an electrical signal can be applied to the first electrode and the second electrode after the biopsy sampling is completed, thereby increasing the temperature of the tissue to be ablated that contacts the first electrode, eliminating the diseased tissue attached to the needle core, and preventing needle tract transfer while achieving hemostasis.
[0028] It should be understood that the contents described in this section are not intended to identify the key or important features of the embodiments of the present utility model, nor are they intended to limit the scope of the present utility model. Other features of the present utility model will become easily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.
[0030] Figure 1 A schematic cross-sectional structure diagram of an ablation device provided in an embodiment of the utility model;
[0031] Figure 2 A schematic cross-sectional structure diagram of another ablation device provided by an embodiment of the utility model;
[0032] Figure 3 A schematic diagram of the structure of an ablation device provided by an embodiment of the utility model;
[0033] Figure 4 A schematic diagram of the structure of a needle core in an ablation device provided in an embodiment of the utility model;
[0034] Figure 5 A schematic diagram of the structure of an outer sleeve in an ablation device provided in an embodiment of the utility model
[0035] Figure 6 A schematic diagram of a medical device in a biopsy state provided by an embodiment of the utility model. DETAILED DESCRIPTION
[0036] In order to enable those skilled in the art to better understand the solution of the utility model, the technical solution in the embodiment of the utility model will be clearly and completely described below in conjunction with the drawings in the embodiment of the utility model. Obviously, the described embodiment is only a part of the embodiment of the utility model, not all of the embodiments. Based on the embodiment of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the utility model.
[0037] It should be noted that the terms "first", "second", etc. in the specification and claims of the utility model and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the utility model described here can be implemented in an order other than those illustrated or described here. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.
[0038] Figure 1 A schematic cross-sectional view of an ablation device provided in an embodiment of the utility model, referring to Figure 1 , the ablation device comprises:
[0039] The needle core includes a main body 101, a first insulating layer 102, a first electrode 103 and a second electrode 104; the first electrode 103, the first insulating layer 102 and the second electrode 104 are sequentially sleeved outside the main body 101 along the extension direction X of the main body 101, and the first electrode 103 and the second electrode 104 are electrically isolated by the first insulating layer 102.
[0040] Optionally, the main body 101, the first insulating layer 102, the first electrode 103 and the second electrode 104 are all tubular structures, so that the needle core can penetrate into human tissue more smoothly. When the main body 101 is a tubular structure, the first insulating layer 102, the first electrode 103 and the second electrode 104 are all tubular structures, which can fit the main body 101 more closely.
[0041] Optionally, the outer surface of the first electrode 103 is parallel to the portion of the main body 101 , the outer surface of the first insulating layer 102 and the outer surface of the second electrode 104 are all flush, so that the needle core can penetrate into the human tissue more smoothly and reduce damage to the human tissue.
[0042] The first electrode 103 and the second electrode 104 are conductive structures, which may be conductive metals. The first insulating layer 102 is made of insulating materials, such as PEEK, polyparaxylene, PI and other materials. The main body 101 of the needle core may be a conductive structure or an insulating structure, which is not limited. If the main body 101 is a conductive structure, an insulating layer must be added between the second electrode 104 and the main body 101 to electrically isolate the second electrode 104 from the main body 101. The first electrode 103 is disposed at the front end of the needle core, wherein the front end is an end for puncturing skin tissue, and the first electrode 103 may be a triangular puncture surface to facilitate the needle core to smoothly penetrate human tissue. The front end in the present utility model is an end for puncture, and the rear end is an end corresponding to the front end and away from the puncture end.
[0043] After sampling is completed, the needle core is inserted into the skin tissue, a first electrical signal is applied to the first electrode 103, and a second electrical signal is applied to the second electrode 104, so that a conductive loop is formed between the device that outputs the electrical signal, the first electrode 103, the tissue to be ablated, and the second electrode 104. When the current flows through the tissue to be ablated, the rapid change of the electromagnetic field causes the polarized water molecules in the tissue to be ablated to move at high speed, generating heat (i.e., endogenous heat effect), causing the water in the tissue to be ablated to evaporate, dry, shrink and fall off, resulting in aseptic necrosis, and eliminating the diseased tissue attached to the needle core. The first electrical signal and the second electrical signal can both be sinusoidal electrical signals or both be pulse electrical signals.
[0044] In the embodiment of the utility model, by arranging an electrically isolated first electrode and a second electrode on the needle core, an electrical signal can be applied to the first electrode and the second electrode after the biopsy sampling is completed, thereby increasing the temperature of the tissue to be ablated that contacts the first electrode, eliminating the diseased tissue attached to the needle core, and preventing needle tract transfer while achieving hemostasis.
[0045] Continue to refer Figure 1 , Optionally, the body portion 101 and the first electrode 103 are an integrated structure;
[0046] The needle core further includes: a second insulating layer 105 disposed between the main body 101 and the second electrode 104 , and the second electrode 104 and the main body 101 are electrically isolated by the second insulating layer 105 .
[0047] The main body 101 and the first electrode 103 are an integrated structure, which is simple and easy to implement. When the main body 101 is also a conductive structure, the rear end of the main body 101 can be connected to the first electrical signal, so that the first electrode 103 can be connected to the first electrical signal through the main body 101. The rear end of the main body 101 is the end away from the first electrode 103.
[0048] The main body 101 is a conductive structure. Since the main body 101 is connected to the first electrical signal and the second electrode 104 is connected to the second electrical signal, in order to avoid a short circuit caused by contact between the main body 101 and the second electrode 104, a second insulating layer 105 is added to isolate the main body 101 from the second electrode 104. When the main body 101 is a tubular structure, the second insulating layer 105 is also a tubular structure so as to be more closely mounted outside the main body 101.
[0049] Continue to refer Figure 1 Optionally, part of the second insulating layer 105 is located between the second electrode 104 and the main body 101 , and the rest of the second insulating layer 105 is located between the first insulating layer 102 and the main body 101 .
[0050] Along the extension direction X of the needle core, the first electrode 103, the first insulating layer 102 and the second electrode 104 are arranged in sequence, and the first insulating layer 101 is in contact with the first electrode 103 and the second electrode 104 respectively. In order to prevent the second electrode 104 from contacting the main body 101 at the junction of the first insulating layer 101 and the second electrode 104, resulting in a signal short circuit, the second insulating layer 105 is arranged to be longer along the extension direction X of the needle core, so that the second electrode 105 is completely isolated from the main body 101 by the second insulating layer 105, and the part of the first insulating layer 102 at the junction with the second electrode 104 is also isolated from the main body 101 by the second insulating layer 105, so as to ensure the electrical isolation of the second electrode 104 and the main body 101.
[0051] Optionally, the ablation device further comprises:
[0052] The outer sleeve 11 , in the needle insertion state and / or the ablation state, the needle core is configured to be sleeved in the outer sleeve, and when the needle core is sleeved in the outer sleeve 11 , the end of the outer sleeve 11 exposes at least a portion of the second electrode 104 .
[0053] The outer sleeve and the needle core are coaxially arranged. In the needle insertion state, the needle core is sleeved in the outer sleeve for puncturing human tissue. Optionally, the outer sleeve 11 may only include a single-layer insulation structure, and the end of the outer sleeve 11 is tilted against the needle core, so that the outer sleeve 11 can smoothly penetrate into the human tissue, while preventing the tissue fluid of the tissue to be ablated from entering the outer sleeve 11. In the ablation state, the needle core is sleeved in the outer sleeve 11. After applying an electrical signal to the first electrode 103 and the second electrode 104, the device that outputs the electrical signal, the first electrode, the tissue to be ablated, and the second electrode form a closed loop. After the ablated tissue is heated, the diseased tissue attached to the needle core and the arm of the outer sleeve 11 is eliminated, and while achieving hemostasis, the needle tract is prevented from shifting.
[0054] Figure 2 A cross-sectional structural diagram of another ablation device provided in an embodiment of the utility model, referring to Figure 2, Optionally, the outer sleeve includes: a third electrode 111 and a third insulating layer 112;
[0055] The third insulating layer 112 is disposed on the outer surface of the third electrode 111 and exposes the end of the third electrode 111;
[0056] When the needle core is sleeved in the outer sleeve, the third electrode 111 contacts the second electrode 104 and at least the first electrode 103 is exposed, and the first electrode 103 and the third electrode 111 are electrically insulated.
[0057] The third insulating layer 112 and the third electrode 111 can both be tubular structures. The third insulating layer 112 is sleeved outside the third electrode 111 and exposes the end of the third electrode 111, so that the human tissue contacts the end of the third electrode 111, so that in the ablation state, after the first electrical signal and the second electrical signal are applied to the first electrode 103 and the second electrode 104 respectively, a conductive loop is formed between the device that outputs the electrical signal, such as the pulse generator, the first electrode 103, the human tissue, the third electrode 111, and the second electrode 104. In this embodiment, it is exemplarily shown that the third electrode 111 exposes the first electrode 103 and the part of the first insulating layer 102, so that during the operation, when the needle is inserted, the needle core slightly penetrates the target tissue (lesion tissue), the outer sleeve contacts the target tissue, and the outer sleeve forms a needle track that is relatively isolated from the tissue, thereby avoiding damage to other tissues during the puncture process. In this embodiment, the second electrode 104 forms a conductive path with the first electrode 103 through the third electrode 111 and human tissue, so that the second electrode 104 can form a conductive path through the third electrode 111 when the length is limited, thereby achieving the effect of ablation. The first electrode 103 and the third electrode 111 are electrically isolated to avoid short circuit.
[0058] Figure 3 A schematic diagram of the structure of an ablation device provided in an embodiment of the utility model is shown in FIG. Figure 4 This is a schematic diagram of the structure of a needle core in an ablation device provided in an embodiment of the utility model. Figure 5 A schematic diagram of the structure of an outer sleeve in an ablation device provided in an embodiment of the utility model, referring to Figure 3-Figure 5 Optionally, the ablation device further includes: a needle core handle 12, the needle core handle 12 is fixedly connected to the needle core 10;
[0059] The ablation device further includes an outer sleeve seat 13, which is fixedly connected to the outer sleeve 11;
[0060] The needle core handle 12 and the outer sleeve seat 13 are detachably connected. The needle core handle 12 and the outer sleeve seat 13 are configured to sleeve the needle core 10 inside the outer sleeve 11 when connected.
[0061] The second electrode 104, the second insulating layer 105 and the main body 101 at the rear end of the needle core 10 can be fixedly connected to the needle core handle 12 to achieve a fixed connection between the needle core handle 12 and the needle core 10. The third electrode 111 and the third insulating layer 112 at the rear end of the outer sleeve 11 are fixedly connected to the outer sleeve seat 13 to achieve a fixed connection between the outer sleeve seat 13 and the outer sleeve 11. The needle core handle 12 and the outer sleeve seat 13 can be a matching structure, such as a Luer male connector and a Luer female connector, and then the needle core 10 is inserted into the outer sleeve 11 when the two are connected.
[0062] Optionally, the ablation device further includes a needle core wire 14, and the needle core wire 14 includes a first wire and a second wire. The first electrode is connected to the first electrical signal through the first wire, and the second electrode is connected to the second electrical signal through the second wire.
[0063] The present invention also provides a medical device, including the ablation device in any of the above embodiments. The beneficial effects of the medical device are the same as those of the ablation device, which will not be described in detail here.
[0064] refer to Figure 1 , optionally, the medical equipment also includes:
[0065] An energy generator, the energy generator is electrically connected to the first electrode 103 and the second electrode 104 respectively;
[0066] The energy generator is used to output a first electrical signal to the first electrode 103 and a second electrical signal to the second electrode 104 in the ablation state, wherein the first electrical signal and the second electrical signal are both sinusoidal electrical signals, or the first electrical signal and the second electrical signal are both pulse electrical signals.
[0067] The energy generator may be a pulse generator or a radio frequency generator, and is used to apply an electrical signal to the first electrode and the second electrode.
[0068] In the ablation state, the energy generator outputs a first electrical signal and a second electrical signal, and the pulse generator, the first electrode 103, the human tissue, and the second electrode 104 form a conductive loop to accumulate heat at the tissue to be ablated, thereby achieving the purpose of ablation and hemostasis.
[0069] Figure 6 A schematic diagram of a medical device in a biopsy state provided by an embodiment of the utility model, referring to Figure 6 Optionally, the medical device further comprises a biopsy puncture needle 15, which is configured to be sheathed in the outer sleeve 11 for tissue sampling in a biopsy state; the needle core is configured to be independent of the outer sleeve 11 in a biopsy state;
[0070] Furthermore, the biopsy puncture needle 15 is configured to be independent of the outer sleeve 11 in the needle insertion state and / or the ablation state.
[0071] refer to Figure 2-Figure 6 Optionally, the working process of the medical device includes a needle insertion state, a biopsy state and an ablation state. In the needle insertion state, the needle core 10 is configured to be sleeved in the coaxial outer sleeve 11 and fixed, and the biopsy puncture needle 15 is configured to be independent of the outer sleeve 11. Specifically, in the needle insertion state, the needle core handle 12 and the outer sleeve seat 13 are connected to sleeve the needle core 10 in the outer sleeve 11, and after the sleeve is completed, the two perform skin tissue puncture together. When the needle core 10 and the outer sleeve 11 puncture to the target tissue under the guidance of the image, the needle core 10 slightly penetrates the target tissue, the outer sleeve 11 contacts the target tissue, and the outer sleeve 11 forms a needle track relatively isolated from the target tissue. Among them, the target tissue can be a diseased tissue to be sampled. After the puncture is in place, the connection between the needle core handle 12 and the outer sleeve seat 13 is disconnected, and the needle core 10 is pulled out from the outer sleeve 11, and the outer sleeve 11 remains in the human tissue. In the biopsy state, the biopsy puncture needle 15 is configured to be sleeved in the outer sleeve 11, and the needle core 10 is configured to be independent of the outer sleeve 11. After the biopsy puncture needle 15 is sleeved in the outer sleeve 11, it enters the target object for tissue sampling. After the sampling is completed, it enters the ablation state. In the ablation state, the needle core 10 is configured to be sleeved in the outer sleeve 11, and the biopsy puncture needle 15 is configured to be independent of the outer sleeve 11. The energy generator outputs a first electrical signal to the first electrode 103 and a second electrical signal to the second electrode 104, so that the energy generator, the first electrode 103, the human tissue and the second electrode 104 form a conductive loop. In the ablation state, the energy generator outputs an electrical signal to perform thermal ablation and hemostasis on the tissue contacted by the outer wall of the needle core 10, and eliminate the lesion tissue attached to the wall of the needle core 10. After the ablation is completed, the needle core 10 and the outer sleeve 11 are pulled out of the human tissue together to end the working process.
[0072] It should be understood that the various forms of processes shown above can be used to reorder, add or delete steps. For example, the steps described in the present invention can be performed in parallel, sequentially or in different orders, as long as the desired results of the technical solution of the present invention can be achieved, and this document does not limit this.
[0073] The above specific implementations do not constitute a limitation on the protection scope of the present utility model. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions can be made according to design requirements and other factors. Any modification, equivalent substitution and improvement made within the spirit and principle of the present utility model shall be included in the protection scope of the present utility model.
Claims
1. An ablation device, characterized in that: include: The needle core comprises a main body, a first insulating layer, a first electrode and a second electrode; the first electrode, the first insulating layer and the second electrode are sequentially sleeved outside the main body along the extension direction of the main body, and the first electrode and the second electrode are electrically isolated by the first insulating layer.
2. The ablation device according to claim 1, characterized in that: The main body and the first electrode are an integrated structure; The needle core further includes: a second insulating layer, which is arranged between the main body and the second electrode, and the second electrode and the main body are electrically isolated by the second insulating layer.
3. The ablation device according to claim 2, characterized in that: A portion of the second insulating layer is located between the second electrode and the main body, and the other portion is located between the first insulating layer and the main body.
4. The ablation device according to claim 1, characterized in that: Also includes: The outer sleeve, in the needle insertion state and / or the ablation state, the needle core is configured to be sleeved in the outer sleeve, and when the needle core is sleeved in the outer sleeve, the end of the outer sleeve exposes at least a portion of the second electrode.
5. The ablation device according to claim 1, characterized in that: Also includes: An outer sleeve, in the needle insertion state and / or the ablation state, the needle core is configured to be sleeved in the outer sleeve; The outer sleeve comprises: a third electrode and a third insulating layer; The third insulating layer is disposed on the outer surface of the third electrode and exposes the end of the third electrode, and the third electrode is a tubular structure; When the needle core is sleeved in the outer sleeve, the third electrode contacts the second electrode and at least the first electrode is exposed, and the first electrode is electrically insulated from the third electrode.
6. The ablation device according to claim 4 or 5, characterized in that: Also includes: A needle core handle, wherein the needle core handle is fixedly connected to the needle core; The ablation device also includes an outer sleeve seat, which is fixedly connected to the outer sleeve; The needle core handle and the outer sleeve seat are detachably connected, and the needle core handle and the outer sleeve seat are configured to set the needle core in the outer sleeve when connected.
7. The ablation device according to claim 1, characterized in that: A portion of an outer surface of the first electrode parallel to the body portion, an outer surface of the first insulating layer, and an outer surface of the second electrode are all flush.
8. A medical device, characterized in that: Comprising the ablation device according to any one of claims 1-7.
9. The medical device according to claim 8, characterized in that Also includes: an energy generator, the energy generator being electrically connected to the first electrode and the second electrode respectively; The energy generator is used to output a first electrical signal to the first electrode and a second electrical signal to the second electrode in an ablation state, wherein the first electrical signal and the second electrical signal are both sinusoidal electrical signals, or the first electrical signal and the second electrical signal are both pulse electrical signals.
10. The medical device according to claim 8, characterized in that The ablation device includes an outer sleeve; The medical device further comprises: a biopsy puncture needle, wherein the biopsy puncture needle is configured to be sheathed in the outer sleeve for tissue sampling in a biopsy state; the needle core is configured to be independent of the outer sleeve in the biopsy state; Furthermore, the biopsy puncture needle is configured to be independent of the outer sleeve in a needle insertion state and / or an ablation state.