Puncture ablation needle capable of being magnetically positioned

Abstract

The utility model relates to the technical field of medical instruments, and discloses a puncture ablation needle capable of being magnetically positioned. The localizable puncture ablation needle comprises a needle body, a handle and a navigation mechanism, the needle body is electrically connected with ablation equipment; the handle is arranged at the near end of the needle body; the navigation mechanism comprises a sensor and a navigation controller; the navigation sensor is arranged in the handle and electrically connected with the navigation controller, and the navigation sensor is used for positioning and navigation during puncture. According to the localizable puncture ablation needle, after the position of a focus is determined through CT, MRI image development and the like, the navigation controller determines a puncture path, and during puncture, the navigation sensor guides the puncture ablation needle to advance along the puncture path in real time, so that real-time positioning and navigation of the puncture needle are realized, and the puncture ablation needle accurately reaches the focus.

Description

Technical Field

[0001] An embodiment of the utility model relates to the technical field of medical devices, and particularly relates to a magnetically positionable puncture ablation needle. Background Technique

[0002] Thermal ablation technology is a minimally invasive, efficient, convenient and safe tumor treatment technology, which has been widely used clinically at present.

[0003] In the most commonly used thermal ablation technology at present, after determining the lesion position through CT or MRI imaging, a radiofrequency or microwave ablation needle is percutaneously punctured to the tumor lesion position, and the temperature of the tumor tissue is raised to the protein coagulation temperature by radiofrequency or microwave energy and maintained for a period of time to cause coagulative necrosis of tumor cells.

[0004] The most critical technical point of the percutaneous ablation needle lies in positioning. At present, when the ablation needle is punctured, it is difficult to position the puncture direction and depth of the ablation needle, resulting in the ablation needle being difficult to correctly reach the lesion position and affecting the ablation effect.

[0004] Content of the Utility Model

[0005] The purpose of the utility model is to provide a magnetically positionable puncture ablation needle to solve the problem that the ablation needle in the above background technique is difficult to correctly reach the lesion position.

[0006] An embodiment of the utility model provides a magnetically positionable puncture ablation needle, including a needle body, a handle and a navigation mechanism;

[0007] The needle body is electrically connected to the ablation device;

[0008] The handle is arranged at the proximal end of the needle body;

[0009] The navigation mechanism includes: a navigation sensor and a navigation controller;

[0010] The navigation sensor is arranged in the handle and is electrically connected to the navigation controller. The navigation sensor is used for positioning and navigation during puncture.

[0011] Based on the above solution, for the positionable puncture ablation needle of the present utility model, by providing a needle tube, a needle tip, a handle, a wire, and a navigation mechanism, the needle tip and the handle are respectively arranged at the distal end and the proximal end of the needle tube. One end of the wire is connected to the needle tip, and the other end is electrically connected to the ablation device. The navigation mechanism includes: a navigation sensor and a navigation controller. The navigation sensor is arranged inside the handle and is electrically connected to the navigation controller. For the positionable puncture ablation needle of the present utility model, after determining the lesion position through CT, MRI imaging, etc., the puncture path and distance calculation and planning are determined preoperatively through the navigation controller, effectively avoiding hard tissues and blood vessels, etc. During puncture, the navigation sensor guides the puncture needle to travel along the puncture path in real time, realizing the real-time positioning and navigation of the puncture needle, so as to monitor in real time whether the puncture needle deviates during the puncture process, and finally enabling the puncture needle to accurately reach the lesion site.

[0012] In a feasible solution, the navigation sensor is set as a magnetic navigation sensor.

[0013] In a feasible solution, the navigation mechanism further includes: a protective tube, a sensor connector, and a sensing wire;

[0014] At least a part of the protective tube is arranged inside the handle and part of it extends out of the handle;

[0015] The sensor connector is arranged on the protective tube;

[0016] The sensing wire is arranged inside the protective tube, and the navigation sensor is electrically connected to the sensor connector through the sensing wire.

[0017] In a feasible solution, a card slot is arranged inside the handle for the protective tube to be embedded.

[0018] In a feasible solution, a boss is arranged on the handle, and the sensor connector is arranged on the boss.

[0019] In a feasible solution, the needle body includes a needle tube and a needle tip; one end of the needle tube is connected to the handle, and the other end is provided with the needle tip; a perfusion hole is arranged on the side wall of the needle tip, and the perfusion hole is communicated with the channel. With this structure, saline perfusion and cooling can be carried out during ablation.

[0020] In a feasible solution, the distal end of the needle tip is in the shape of a triangular prism or a cone. With this structure, it is convenient for the puncture ablation needle to quickly puncture.

[0021] In a feasible solution, a temperature sensor is arranged inside the needle tube; the outer wall of the needle tube is coated with an insulating coating.

[0022] In a feasible solution, a plurality of scale lines are equidistantly arranged on the side surface of the syringe needle, the distance between two adjacent scale lines is 10 mm, and the scale lines are used to indicate the puncture depth. With this structure, it is convenient to observe the puncture depth.

[0023] In a feasible solution, digital marks are provided between two adjacent scale lines of the syringe needle. With this structure, the puncture depth can be more clearly displayed.

[0024] In a feasible solution, the scale lines and the digital marks are formed by laser marking or etching. With this structure, it is ensured that the scale lines and the digital marks are not worn.

[0025] In a feasible solution, a docking part is provided at the end of the handle, and the central axes of the needle body, the navigation sensor, and the docking part coincide with each other. The docking part is used to externally connect a robotic arm. With this structure, the puncture needle can be manipulated by a surgical robot for puncture, and it is ensured that the puncture path is consistent with the planned path during puncture. Description of the Drawings

[0026] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0027] Figure 1 Schematic diagram of the positionable puncture ablation needle in the embodiment of the present invention;

[0028] Figure 2 In the embodiment of the present invention Figure 1 Enlarged view of part A;

[0029] Figure 3 In the embodiment of the present invention Figure 1 Enlarged view of part B;

[0030] Figure 4 Schematic diagram of the inside of the handle in the embodiment of the present invention;

[0031] Figure 5 Schematic diagram of the tip of the needle in the embodiment of the present invention.

[0032] Reference numerals in the figures:

[0033] 1. Needle body; 11. Needle tube; 111. Scale line; 112. Numerical mark; 12. Needle tip; 121. Perfusion hole; 122. Liquid inlet channel; 13. Handle; 131. Rotating cap; 132. Card slot; 133. Docking part; 21. Navigation sensor; 22. Protection tube; 23. Sensor connector; Boss 24. Specific implementation manner

[0034] To make the objectives, technical solutions and advantages of the embodiments of the present utility model clearer, the technical solutions in the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model. Apparently, the described embodiments are some but not all of the embodiments of the present utility model. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present utility model without creative efforts shall fall within the protection scope of the present utility model.

[0035] In the description of the present utility model, it should be understood that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present utility model.

[0036] In the present utility model, unless otherwise clearly defined and limited, the terms "installed", "connected", "connected", "fixed", etc. shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral one; it may be a mechanical connection, an electrical connection, or a communication connection; it may be a direct connection, or an indirect connection through an intermediate medium, and it may be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0037] The technical solutions of the present utility model will be described in detail below with specific embodiments. These specific embodiments can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments.

[0038] As described in the background technology of this application, the most commonly used thermal ablation technology is to determine the location of the lesion through CT or MRI imaging, and then percutaneously puncture a radio frequency or microwave ablation needle to the location of the tumor lesion. The radio frequency or microwave energy is used to make the temperature of the tumor tissue reach the protein coagulation temperature and maintain it for a period of time, causing coagulative necrosis of the tumor cells.

[0039] The inventors of the present application have discovered that existing ablation needles cannot achieve real-time image guidance during puncture, and cannot determine whether there is a deviation between the needle insertion direction and the lesion location, making it difficult for the ablation needle to accurately reach the lesion location; puncture is mostly performed manually by the operator, and manual puncture requires high operator experience and operating skills, and there is a risk of puncture deviation.

[0040] In order to solve the above problems, the inventor of the present application proposed the technical solution of the present application, and the specific embodiments are as follows:

[0041] Figure 1 is a schematic diagram of a puncture ablation needle capable of magnetic positioning in an embodiment of the utility model, Figure 2 In the embodiment of the utility model Figure 1 The enlarged view of A in Figure 3 In the embodiment of the utility model Figure 1 The enlarged view of point B in the figure, Figure 4 This is a schematic diagram of the interior of the handle in an embodiment of the utility model. Figure 5 Schematic diagram of the needle tip in the embodiment of the utility model. Figures 1 to 5 As shown, the locatable puncture ablation needle of this embodiment includes: a needle body 1, a handle 13, a guide wire and a navigation mechanism.

[0042] The needle body 1 comprises a needle tube 11 and a needle head 12, wherein the needle tube 11 is a hollow tube and has a through passage axially therethrough. The needle tube 11 and the needle head 12 may be an integral structure or a separate structure.

[0043] In one embodiment, the needle tube 11 and the needle 12 are manufactured separately, and the needle 12 is disposed at the distal end of the needle tube 11 . The needle 12 can be fixedly connected to the needle tube 11 by laser welding.

[0044] The handle 13 is arranged at the proximal end of the needle tube 11 for the operator to hold. The handle 13 is formed by detachably splicing a left handle and a right handle, and the needle tube 11 is fixedly connected to a screw cap 131 of the handle 13.

[0045] An ablation wire (not shown) is passed through the channel of the needle tube 11, one end (distal end) of the ablation wire is connected to the needle 12, and the other end (proximal end) of the ablation wire extends into the handle 13 and is electrically connected to the wire connector at the rear end of the handle 13. The wire connector on the handle 13 is used for external ablation equipment such as radio frequency and microwave.

[0046] The navigation mechanism includes a navigation sensor 21 and a navigation controller. The navigation sensor 21 is disposed within the handle 13 and is electrically connected to the navigation controller. The navigation sensor is used to achieve positioning and navigation of the puncture ablation needle during puncture.

[0047] Preferably, when the navigation sensor 21 is disposed within the handle 13, the central axis of the navigation sensor 21 coincides with the central axis of the needle body 1. Thus, when the central axis of the needle body 1 moves, the central axis of the navigation sensor 21 moves accordingly, facilitating the navigation sensor 21 to quickly and real-time sense the pose change of the needle body 1.

[0048] It can be easily found from the above content that for the positionable puncture ablation needle of this embodiment, by providing a needle tube, a needle tip, a handle, an ablation wire, and a navigation mechanism, the needle tip and the handle are respectively disposed at the distal end and the proximal end of the needle tube, one end of the wire is connected to the needle tip, and the other end is electrically connected to an ablation device. The navigation mechanism includes a navigation sensor and a navigation controller. The navigation sensor is disposed within the handle and is electrically connected to the navigation controller. The central axis of the navigation sensor coincides with the central axis of the needle tube, which can ensure that the puncture path and the planned path are consistent during puncture. For the positionable puncture ablation needle of this embodiment, after determining the lesion location through CT, MRI imaging, etc., the navigation controller can determine the puncture path before the operation. During puncture, the navigation sensor guides the puncture needle to travel along the puncture path in real time, enabling the puncture needle to accurately reach the lesion. By using the navigation and positioning function, the calculation and planning of the puncture path and distance before the operation can be realized, effectively avoiding hard tissues and blood vessels, etc., and being able to monitor in real time whether the puncture process deviates, so as to monitor in real time whether the puncture needle deviates during the puncture process and whether the final position is accurate. The needle tip is connected to a radiofrequency or microwave ablation device through a wire, and the energy is applied to the lesion tissue to obtain the best ablation effect.

[0049] In one embodiment, the navigation sensor 21 is a magnetic navigation sensor, and the magnetic navigation sensor and the navigation controller perform navigation and positioning based on magnetism. The magnetic navigation sensor includes a magnetic positioning chip, and the magnetic positioning chip is electrically connected to the navigation controller. The navigation controller can know the real-time depth of the needle body puncture in real time based on the magnetic positioning chip. It can be understood that by adopting magnetic navigation, the structure of the navigation mechanism is simpler, and the steps to achieve navigation are simpler. In other embodiments, the navigation method of the navigation mechanism is not limited to the above-mentioned magnetic navigation, for example, it can also be optical navigation.

[0050] It should be noted that in this embodiment, except for the magneto-navigation sensor, the sensing wire and other conductive functional wires, all metal parts are made of non-magnetic or weakly magnetic metals to reduce signal interference with the magneto-navigation sensor. The materials of the metal parts include, but are not limited to, 316L stainless steel, non-magnetic alloy, etc. In other embodiments, the navigation technology of the navigation mechanism is not limited to the above, for example, it can also be based on technologies such as optical navigation.

[0051] Optionally, as Figure 2 , Figure 4 shown, for the positionable puncture ablation needle in this embodiment, the navigation mechanism further includes: a protective tube 22, a sensor connector 23, and a sensing wire. The protective tube 22 is at least partially disposed within the handle 13 and partially extends out of the handle 13. The sensing wire is threaded through the protective tube 22, and the navigation sensor 21 is electrically connected to the sensor connector 23 through the sensing wire. Among them, the protective tube 22 is used to protect the sensing wire and prevent the sensing wire from being bent.

[0052] Specifically, the protective tube 22 is inclined and disposed within the handle 13, and the tail end of the protective tube 22 extends out of the handle 13. The sensor connector 23 is disposed at the end of the protective tube 22. The sensing wire of the magneto-navigation sensor 21 is threaded through the protective tube 22 and electrically connected to the sensor connector 23. The sensor connector 23 is used to be electrically connected to the navigation controller. In this embodiment, the sensing wire of the magneto-navigation sensor is threaded through the protective tube and connected to the sensor connector. By providing the protective tube 22, it not only protects the sensing wire and prevents the sensing wire from being bent, but also facilitates the connection and use of the magneto-navigation sensor and the navigation controller.

[0053] Furthermore, for the positionable puncture ablation needle in this embodiment, a card slot 132 is provided within the handle 13, and the protective tube 22 is snap-fitted into the card slot 132 of the handle 13 to prevent the protective tube 22 from shaking within the handle.

[0054] Optionally, referring to Figure 2 , a boss 24 is provided on the handle. The sensor connector 23 is disposed on the boss 24. In this embodiment, the boss 24 and the handle are of an integral structure. The boss 24 forms an inclined side at the tail end of the handle for installing various connectors. Providing the boss is beneficial to increasing the installation area of the connectors. Placing the connectors on the boss 24 can also avoid occupying other spaces and reserve sufficient space for the connection structure at the tail end of the handle.

[0055] Optionally, as Figure 5As shown, for the positionable puncture ablation needle in this embodiment, a plurality of perfusion holes 121 are provided on the circumferential side wall of the needle tip 12, and a liquid inlet channel 122 is provided at one end of the needle tip 12. The perfusion holes 121 of the needle tip 12 are communicated with the channel of the needle tube 11 through the liquid inlet channel 122. A saline pipeline is provided in the channel of the needle tube 11. During ablation, saline can be perfused into the lesion through the saline pipeline and the perfusion holes to cool the lesion during ablation.

[0056] Optionally, for the positionable puncture ablation needle in this embodiment, the distal end of the needle tip 12 is in the shape of a triangular prism or the distal end of the needle tip 12 is in the shape of a cone, which facilitates the rapid puncture of the puncture ablation needle.

[0057] Optionally, as Figure 1 、 Figure 3 shown, for the positionable puncture ablation needle in this embodiment, a plurality of scale lines 111 are equidistantly arranged on the circumferential side surface of the needle tube 11, and the distance between two adjacent scale lines 111 is 10 mm. During the puncture of the puncture ablation needle, the puncture depth can be determined through the scale lines 111 on the needle tube 11. Of course, in other embodiments, the distance between adjacent scale lines can be set to any other length, such as 1 mm, 5 mm, 20 mm, etc., which is not limited here.

[0058] Furthermore, for the positionable puncture ablation needle in this embodiment, digital marks 112 are provided between two adjacent scale lines 111 of the needle tube 11, and the digital marks 112 are marked with consecutive Arabic numerals. During the puncture of the puncture ablation needle, the puncture depth can be determined more clearly and clearly according to the combination of the scale lines 111 and the digital marks 112, without the user having to make a secondary distance judgment.

[0059] Furthermore, for the positionable puncture ablation needle in this embodiment, the scale lines 111 and the digital marks 112 on the needle tube 11 are formed by laser marking or etching, ensuring that the scale lines and the digital marks will not be worn during use.

[0060] Optionally, for the positionable puncture ablation needle in this embodiment, a temperature sensor is provided in the needle tube 11, and the temperature sensor is electrically connected to an external controller to monitor the temperature during the ablation process.

[0061] The outer wall of the needle tube 11 is coated with a polymer insulating coating. The insulating layer can prevent the conduction of radio frequency current to avoid burning normal human tissues.

[0062] Furthermore, for the positionable puncture ablation needle in this embodiment, a docking part 133 is provided at the proximal end of the handle 13. In this embodiment, as Figure 4As shown, the docking part 133 is a tail-end protrusion, and the central axes of the needle tube 11, the magnetic navigation sensor 21, and the tail-end protrusion coincide with each other. The docking part 133 of the handle 13 is used for detachable connection with a surgical robot or a robotic arm, and the puncture ablation needle is punctured by operating the robotic arm. In other embodiments, the specific structure of the docking part 133 is not limited to the tail-end protrusion structure described above or shown in the figure, and may also be a structure such as clamping or threaded connection with a robotic arm, etc.

[0063] For the positionable puncture ablation needle of the present utility model, its working process is as follows:

[0064] 1) Preoperative positioning: Positioning is performed through CT images and a navigation system to determine the location of the lesion.

[0065] 2) Puncture path planning is performed according to the location of the lesion and image or software data, avoiding hard bone tissues and blood vessels, finding the optimal puncture path, and making a mark on the skin at the puncture point of the patient.

[0066] 3) Assemble the puncture ablation needle on the surgical robot or robotic arm, and by operating the surgical robot or robotic arm, make the needle tube of the puncture ablation needle be on the puncture path.

[0067] 4) Through calculation by the navigation mechanism, determine the position of the tip of the puncture ablation needle, and then determine the relative distance between the tip of the puncture ablation needle and the lesion. Control the surgical robot or robotic arm to slowly puncture along the puncture path, and observe whether the tip deviates from the skin marking point. If deviation occurs, stop puncturing; if there is no deviation, continue puncturing until reaching the lesion position. Determine the puncture depth by observing the scale line on the needle tube, and roughly judge whether the puncture depth meets the requirements.

[0068] 5) Determine again through CT images whether the tip position reaches the center of the lesion.

[0069] 6) After confirming that the position is correct, perform ablation according to the doctor's preoperative evaluation.

[0070] 7) After ablation, determine again through CT images whether the ablation range completely covers the lesion.

[0071] 8) After determining that the ablation effect is completely covered, control the surgical robot or robotic arm to withdraw the puncture ablation needle along the original path from the human body, and perform timely hemostasis treatment.

[0072] In the present utility model, unless otherwise clearly specified and defined, the first feature being "on" or "under" the second feature may be that the first feature is in direct contact with the second feature, or the first feature and the second feature are indirectly in contact through an intermediate medium.

[0073] Moreover, for the first feature being "above", "over" and "on" the second feature, it may mean that the first feature is directly above or obliquely above the second feature, or simply indicates that the first feature is at a higher level than the second feature in terms of horizontal height. For the first feature being "below", "under" and "beneath" the second feature, it may mean that the first feature is directly below or obliquely below the second feature, or simply indicates that the first feature is at a lower level than the second feature in terms of horizontal height.

[0074] In the description of this specification, the description with reference to terms such as "one embodiment", "some embodiments", "example", "specific example" or "some examples", etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present utility model. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0075] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present utility model and are not intended to limit them; although the present utility model has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements for some or all of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the various embodiments of the present utility model.

Claims

1. A magnetically positionable puncture ablation needle, characterized in that, Comprising: A needle body, a handle, and a navigation mechanism; The needle body is electrically connected to an ablation device; The handle is disposed at the proximal end of the needle body; The navigation mechanism includes: a navigation sensor and a navigation controller; The navigation sensor is disposed within the handle, electrically connected to the navigation controller, and the navigation sensor is used for positioning and navigation during puncture; The navigation mechanism further includes: a protective tube, a sensor connector, and a sensing wire; The protective tube is at least partially disposed within the handle and partially extends out of the handle; The sensor connector is disposed on the protective tube; The sensing wire is disposed within the protective tube, and the navigation sensor is electrically connected to the sensor connector through the sensing wire.

2. The magnetically positionable puncture ablation needle according to claim 1, characterized in that, The navigation sensor is set as a magnetic navigation sensor.

3. The magnetically positionable puncture ablation needle according to claim 1, characterized in that, A card slot is provided within the handle for the protective tube to be embedded therein.

4. The magnetically positionable puncture ablation needle according to claim 1, characterized in that, A boss is provided on the handle, and the sensor connector is disposed on the boss.

5. The magnetically positionable puncture ablation needle according to claim 1, characterized in that, The needle body includes a needle tube and a needle tip; One end of the needle tube is connected to the handle, and the other end is provided with the needle tip; Perfusion holes are provided on the side wall of the needle tip, and the perfusion holes are communicated with a liquid inlet channel.

6. The magnetically positionable puncture ablation needle according to claim 5, characterized in that, The distal end of the needle tip is in the shape of a triangular prism or a cone.

7. The magnetically positionable puncture ablation needle according to claim 5, characterized in that, A temperature sensor is disposed within the needle tube; The outer wall of the needle tube is coated with an insulating coating.

8. The magnetically positionable puncture ablation needle according to claim 5, characterized in that, A plurality of scale lines are equidistantly arranged on the side surface of the needle tube, and the distance between two adjacent scale lines is 10 mm. The scale lines are used to indicate the puncture depth; Digital markings are provided between two adjacent scale lines on the needle tube.

9. The magnetically positionable puncture ablation needle according to any one of claims 1 to 8, characterized in that, A docking portion is provided on the handle, and the central axes of the needle body, the navigation sensor, and the docking portion coincide with each other. The docking portion is used for external connection to a robotic arm.

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