Active biopsy device
By using a pulse generator to output pulse electrical signals in the biopsy device, forming a conductive path to ablate the tissue, the problems of bleeding and pathogenic cell metastasis after biopsy are solved, and effective hemostasis and metastasis prevention effects are achieved.
Patent Information
- Application Number
- CN202420903964.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-28
- Publication Date
- 2025-01-14
- Estimated Expiration
- 2034-04-28
AI Technical Summary
The prior art is difficult to deal with possible bleeding after biopsy sampling in time in tumor puncture and radiofrequency ablation interventional treatment, and lacks effective methods to prevent pathogenic cell metastasis.
An active biopsy device is designed, including an outer cannula, a needle core, a surface electrode and a pulse generator, by outputting pulse electrical signals after the puncture is completed, forming a conductive path to achieve ablation and hemostasis of tissues and preventing the transfer of pathogenic cells.
It effectively realizes the ablation and hemostasis of tissue after puncture, prevents the metastasis of pathogenic cells, reduces bleeding during biopsy and damage to tissue, and improves the safety and accuracy of treatment.
Smart Images
Figure CN222341235U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical instruments, in particular to an active biopsy device. Background Art
[0002] With the continuous development of medical technology, tumor puncture and radiofrequency ablation interventional treatment are becoming more and more widely used.
[0003] Currently, the most commonly used treatment method in clinical practice is the step-by-step use of coaxial biopsy puncture needles and ablation needles. For example, when taking biopsy samples, the outer sheath is first inserted into the target tissue, that is, the diseased tissue, to locate it, then the needle core in the outer sheath is pulled out, and the biopsy puncture needle is inserted into the outer sheath for sampling, which is then pulled out after multiple samplings are completed.
[0004] However, the above treatment methods cannot promptly handle the bleeding that may occur after biopsy sampling, and do not provide a feasible method for the needle-pathway metastasis of pathogenic cells. Utility Model Content
[0005] The utility model provides an active biopsy device, which can perform ablation and hemostasis after puncture and avoid the transfer of pathogenic cells.
[0006] According to one aspect of the utility model, an active biopsy device is provided, comprising: an outer sleeve, a needle core, a surface electrode and a pulse generator;
[0007] The needle core is detachably sleeved in the outer sleeve;
[0008] The outer sleeve comprises a first needle tip and a first needle body connected in sequence, the first needle tip and the first needle body are both made of conductive material, the first needle body is covered with a first insulating layer, and the first needle tip is used to receive the pulse electrical signal transmitted by the pulse generator in the ablation state;
[0009] The surface electrode is arranged on the surface of skin tissue, is electrically connected to the pulse generator, and forms a conductive path together with the first needle tip in the ablation state.
[0010] Optionally, the active biopsy device further includes a first connector, and the first needle body is fixedly connected to the first connector;
[0011] The needle core comprises a second needle tip and a second needle body, and the second needle tip and the second needle body are connected;
[0012] The active biopsy device further includes a second connector, and the second connector is fixedly connected to the second needle body;
[0013] The first connector and the second connector are detachably connected, and the first connector and the second connector are configured such that when connected, the needle core is sleeved in the outer sleeve.
[0014] Optionally, the active biopsy device further comprises a connecting wire and a plug;
[0015] One end of the connecting wire is electrically connected to the first needle body through the first connector, and the other end of the connecting wire is electrically connected to the plug;
[0016] The plug is electrically connected to the pulse generator.
[0017] Optionally, the active biopsy device further comprises a biopsy tool, and the biopsy tool is used to be sleeved in the outer sleeve in a biopsy state to perform tissue sampling.
[0018] Optionally, in the needle insertion state, the needle core is disposed inside the outer sleeve, and the biopsy tool is independent of the outer sleeve.
[0019] Optionally, in the biopsy state, the biopsy tool is sleeved inside the outer sleeve, and the needle core is independent of the outer sleeve.
[0020] Optionally, in the ablation state, the biopsy tool is independent of the outer sleeve, and the needle core is independent of the outer sleeve.
[0021] Optionally, the pulse generator is configured to output a continuous square wave.
[0022] Optionally, the frequency of the pulse electrical signal output by the pulse generator is 300KHz-800KHz.
[0023] Optionally, the amplitude range of the pulse electrical signal is 1KV-10KV.
[0024] The technical solution of the embodiment of the utility model is to set the first needle tip of the outer sleeve as a conductive structure. In the ablation state, the first needle tip of the outer sleeve is connected to the pulse electric signal, so that the pulse generator providing the pulse electric signal, the first needle tip, the body tissue and the surface electrode form a closed conductive circuit, so that the first needle tip is under the action of the pulse electric signal, so that the temperature of the tissue to be ablated increases, thereby achieving ablation and hemostasis of the needle tract, and eliminating the diseased tissue attached to the outer sleeve to prevent the metastasis of diseased cells.
[0025] 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
[0026] 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.
[0027] Figure 1 A schematic diagram of the structure of an active biopsy device provided in an embodiment of the utility model;
[0028] Figure 2 A schematic diagram of the structure of an outer sleeve provided in an embodiment of the utility model;
[0029] Figure 3 A schematic diagram of the structure of a needle core provided in an embodiment of the utility model;
[0030] Figure 4 A schematic diagram of the structure of the active biopsy device provided in an embodiment of the utility model in a biopsy state;
[0031] Figure 5 A waveform diagram of a pulse electrical signal output by a pulse generator provided in an embodiment of the utility model. DETAILED DESCRIPTION
[0032] 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.
[0033] 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.
[0034] Figure 1A schematic diagram of the structure of an active biopsy device provided in an embodiment of the utility model is shown in FIG. Figure 2 A schematic diagram of the structure of an outer sleeve provided in an embodiment of the utility model is shown in FIG. Figure 3 A schematic diagram of the structure of a needle core provided by an embodiment of the utility model, referring to Figure 1 , Figure 2 and Figure 3 , the active biopsy device comprises: an outer sleeve 10, a needle core 11, a surface electrode and a pulse generator;
[0035] The needle core 11 is detachably sleeved in the outer sleeve 10;
[0036] The outer sleeve 10 comprises a first needle tip 101 and a first needle body 102 connected in sequence, both of which are made of conductive materials, and the first needle body 102 is covered with a first insulating layer, and the first needle tip is used to receive the pulse electrical signal transmitted by the pulse generator in the ablation state;
[0037] The surface electrode is arranged on the surface of the skin tissue, is electrically connected to the pulse generator, and forms a conductive path together with the first needle tip in the ablation state.
[0038] The surface electrode is electrically connected to the pulse generator, specifically, the surface electrode is electrically connected to the ground terminal of the pulse generator, and the ground terminal of the pulse generator is grounded. The pulse generator is used to output a pulse electrical signal, wherein the pulse electrical signal includes a low level and a high level, and the high and low levels are output alternately. The outer sleeve 10 and the needle core 11 are coaxially arranged, and the outer sleeve 10 and the needle core 11 can both be rigid tubes for percutaneous puncture, or the outer sleeve 10 and the needle core 11 can also be flexible or flexible tubes for biopsy puncture under bronchoscope, laparoscope, gastroscope or colonoscope. The first needle tip 101 and the first needle body 102 are made of conductive materials such as conductive metals and have conductivity. Optionally, the first needle tip 101 and the first needle body 102 can be discrete structures, the two are in contact and connected, or they are an integrated structure. The surface electrode is a conductive structure, which is arranged on the surface of the skin tissue. The outer sleeve 10 and the needle core 11 are two independent parts, both of which are hollow structures, and the diameter of the needle core 11 is smaller than that of the outer sleeve 10, so that during operation, the needle core 11 can be detachably sleeved in the outer sleeve 10. The first insulating layer wraps the first needle body 102, exposing the first needle tip 101 at the end, so that the pulse generator, the first needle tip 101 of the outer sleeve 10 and the surface electrode can form a conductive loop.
[0039] The ablation state is a state in which the needle track for puncture sampling is stopped from bleeding. After the biopsy sampling is completed, the ablation state is entered. In the ablation state, the pulse generator outputs a pulse electrical signal, the first needle tip 101 receives the pulse electrical signal, the outer sleeve 10, the tissue to be ablated, the surface electrode and the pulse generator form a closed loop. When the pulse 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 a high speed, generating heat (i.e., endogenous heat effect), causing the water inside and outside the tissue to be ablated to evaporate, dry, shrink and fall off, resulting in aseptic necrosis, and eliminating the diseased tissue attached to the outer sleeve 10.
[0040] The technical solution of the embodiment of the utility model is to set the first needle tip of the outer sleeve as a conductive structure. In the ablation state, the first needle tip is connected to the pulse electric signal, so that the pulse generator, the first needle tip, the tissue to be ablated and the surface electrode form a closed conductive loop, so that the first needle tip of the outer sleeve, under the action of the pulse electric signal, increases the temperature of the tissue to be ablated, achieves hemostasis and ablation of the needle track, and eliminates the diseased tissue attached to the outer sleeve to prevent the transfer of pathogenic cells. At the same time, after the biopsy is completed, the outer sleeve fixed in the skin tissue is directly used for ablation and hemostasis. The outer sleeve is in the body from the time of needle insertion to the completion of ablation. The outer sleeve is used to ablate and hemostasis in the ablation state, and is pulled out after the ablation is completed, avoiding bleeding caused by multiple insertions and withdrawals of the biopsy device, while reducing the number of insertions and withdrawals of the biopsy device in the skin tissue, reducing damage to the tissue.
[0041] Continue to refer Figure 1 , Figure 2 and Figure 3 Optionally, the active biopsy device further includes a first connector 103, and the first needle body 102 and the first connector 103 are fixedly connected;
[0042] The needle core 11 includes a second needle tip 111 and a second needle body 112, and the active biopsy device includes a second connector 113, the second needle tip 111 is connected to one end of the second needle body 112, and the other end of the second needle body 112 is fixedly connected to the second connector 113;
[0043] The first connector 103 and the second connector 113 are detachably connected. The first connector 103 and the second connector 113 are configured to sleeve the needle core 11 inside the outer sleeve 10 when connected.
[0044] Specifically, the second needle tip 111 can adopt a single-bevel tip design, so that when the second needle tip 111 punctures the lesion site, that is, the target tissue, it can improve the accuracy and puncture smoothness to reduce damage to biological tissue. One end of the first needle body 102 is electrically connected to the first needle tip 101. In an optional embodiment, the first needle tip 101 and the first needle body 102 are an integrated structure, one end of the first needle body 102 is fixed to the first connector 103, and the other end, that is, the first needle tip, is used for tissue puncture.
[0045] The needle core and the outer sleeve are detachably connected by the first connector 103 and the second connector 113. The first connector 103 and the second connector 113 are connected to realize the needle core 11 being sleeved in the outer sleeve 10. The needle core 11 can be taken out from the outer sleeve 10 by disconnecting the connection between the first connector 103 and the second connector 113. Optionally, the first connector 103 and the second connector 113 are connected by a rotational connection. In an optional embodiment, the first connector 103 is a Luer male connector, and the second connector 113 is a Luer female connector matching the Luer male connector.
[0046] Continue to refer Figure 1-Figure 3 , Optionally, the active biopsy device further includes a connecting wire 12 and a plug 13;
[0047] One end of the connecting wire 12 is electrically connected to the first needle body 102 through the first connector 103, and the other end of the connecting wire 12 is electrically connected to the plug 13;
[0048] The plug 13 is electrically connected to the pulse generator.
[0049] The connecting wire 12 can be a copper wire, an aluminum wire, etc., and is used to transmit electrical signals. The first connector 103 is electrically connected to the connecting wire 12, the second needle body 102 is electrically connected to the connecting wire 12 through the first connector 103, and the second needle body 102 is electrically connected to the first needle tip 101. Finally, the pulse electrical signal output by the pulse generator is transmitted to the first needle tip 101 through the plug 13, the connecting wire 12, the first connector 103, and the second needle body 102 in sequence.
[0050] Continue to refer Figure 1 , Figure 2 and Figure 3 Optionally, the active biopsy device further comprises a biopsy tool, which is used to be sleeved in the outer sleeve 10 for tissue sampling in the biopsy state. The biopsy state is a state for sampling diseased tissue. The biopsy tool is used to be sleeved in the outer sleeve 10 multiple times in the biopsy state to perform multiple sampling of diseased tissue.
[0051] The working process of the active biopsy device includes a needle insertion state, a biopsy state and an ablation state in sequence. In the needle insertion state, the needle core 11 is configured to be sleeved in the coaxial outer sleeve 10 and fixed, and the biopsy tool is configured to be independent of the outer sleeve 10. Specifically, in the needle insertion state, the first connector 103 and the second connector 113 are connected to sleeve the needle core 11 in the outer sleeve 10, and after the sleeve is completed, the two perform skin tissue puncture together. When the needle core 11 and the outer sleeve 10 puncture to the target tissue under the guidance of the image, the needle core 11 slightly penetrates the target tissue, the outer sleeve 10 contacts the target tissue, and the outer sleeve 10 forms a needle channel 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 first connector 103 and the second connector 113 is disconnected, and the needle core 11 is pulled out from the outer sleeve 10, and the outer sleeve 10 remains in the skin tissue. Figure 4 The schematic diagram of the structure of the active biopsy device in the biopsy state provided by the embodiment of the utility model is shown in FIG. Figure 1-Figure 4 In the biopsy state, the biopsy tool 14 is configured to be sleeved in the outer sleeve 10, and the needle core 11 is configured to be independent of the outer sleeve 10. After the biopsy tool 14 is sleeved in the outer sleeve 10, 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 11 is configured to be independent of the outer sleeve 10, and the biopsy tool is configured to be independent of the outer sleeve 10. The pulse generator transmits the pulse electrical signal to the first needle body 102 through the plug 13 and the connecting wire 12 in sequence, so that the first needle tip 101, the pulse generator and the surface electrode form a conductive circuit. In the ablation state, the pulse generator outputs a pulse electrical signal to perform thermal ablation and hemostasis on the tissue contacted by the outer wall of the outer sleeve 10, and eliminate the lesion tissue attached to the wall of the outer sleeve 10. After the ablation is completed, the outer sleeve 10 is pulled out from the skin tissue to end the working process.
[0052] Figure 5 A waveform diagram of a pulse electrical signal output by a pulse generator provided in an embodiment of the utility model, referring to Figure 5 , optionally, the pulse generator is configured to output a continuous square wave.
[0053] The pulse generator outputs continuous square waves, that is, the pulses of the pulsed electrical signal are uninterrupted, which is conducive to heat accumulation, so that the temperature of the tissue to be ablated increases, achieving the purpose of low-temperature thermal effect and expanding the ablation range. At the same time, the thermal effect can also bring about a hemostatic effect and prevent the needle track from shifting when the biopsy tool is pulled out.
[0054] Optionally, the pulse frequency of the pulse electrical signal output by the pulse generator is 300KHz-800KHz.
[0055] If the frequency of the pulsed electrical signal output by the pulse generator is too high, it will cause excessive heat to be generated during the ablation state, which will have an adverse effect on human health. If the frequency of the pulsed electrical signal is too low, the heat generated by the tissue to be ablated during the ablation state will be insufficient, which will lead to poor ablation and hemostasis effects. Therefore, the frequency of the pulsed electrical signal output by the pulse generator needs to be set between 300KHz and 800KHz, so as to meet the ablation and hemostasis effects without causing adverse effects on the human body.
[0056] Optionally, the amplitude range of the pulsed electric signal is 1KV-10KV. Just like the frequency of the pulsed electric signal, if the amplitude of the pulsed electric signal is too large, the tissue to be ablated will generate too much heat, causing damage to the human body. If the amplitude is too small, the ablation and hemostasis effect will be poor. Therefore, the amplitude of the pulsed electric signal needs to be set at 1KV-10KV so as to achieve the ablation and hemostasis effect without causing adverse effects on the human body.
[0057] 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.
[0058] 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 active biopsy device, characterized in that: include: Outer cannula, needle stylet, surface electrode and pulse generator; The needle core is detachably sleeved in the outer sleeve; The outer sleeve comprises a first needle tip and a first needle body connected in sequence, the first needle tip and the first needle body are both made of conductive material, the first needle body is covered with a first insulating layer, and the first needle tip is used to receive the pulse electrical signal transmitted by the pulse generator in the ablation state; The surface electrode is arranged on the surface of skin tissue, is electrically connected to the pulse generator, and forms a conductive path together with the first needle tip in the ablation state.
2. The active biopsy device according to claim 1, characterized in that: It also includes a first connector, and the first needle body is fixedly connected to the first connector; The needle core comprises a second needle tip and a second needle body, and the second needle tip and the second needle body are connected; The active biopsy device further includes a second connector, and the second connector is fixedly connected to the second needle body; The first connector and the second connector are detachably connected, and the first connector and the second connector are configured such that when connected, the needle core is sleeved in the outer sleeve.
3. The active biopsy device according to claim 2, characterized in that: The active biopsy device also includes a connecting wire and a plug; One end of the connecting wire is electrically connected to the first needle body through the first connector, and the other end of the connecting wire is electrically connected to the plug; The plug is electrically connected to the pulse generator.
4. The active biopsy device according to claim 1, characterized in that: The active biopsy device further comprises a biopsy tool, which is used to be sleeved in the outer sleeve in a biopsy state to perform tissue sampling.
5. The active biopsy device according to claim 4, characterized in that: In the needle insertion state, the needle core is sleeved in the outer sleeve, and the biopsy tool is independent of the outer sleeve.
6. The active biopsy device according to claim 4, characterized in that: In the biopsy state, the biopsy tool is sleeved inside the outer sleeve, and the needle core is independent of the outer sleeve.
7. The active biopsy device according to claim 4, characterized in that: In the ablation state, the biopsy tool is independent of the outer sleeve, and the needle core is independent of the outer sleeve.
8. The active biopsy device according to claim 1, characterized in that: The pulse generator is configured to output a continuous square wave.
9. The active biopsy device according to claim 1, characterized in that: The frequency of the pulse electrical signal output by the pulse generator is 300KHz-800KHz.
10. The active biopsy device according to claim 1, characterized in that: The amplitude range of the pulse electrical signal is 1KV-10KV.