WO2019178940A1 - Flexible ablation electrode having active deformation function and puncturing ablation needle - Google Patents

Abstract

A flexible ablation electrode having an active deformation function, comprising a flexible wrapping layer (1), a force applying layer (2), and a conductive ablation electrode body (3) which are disposed in sequence from outside to inside. The force applying layer, as an active force applying part, includes, but is not limited to, a microchannel filled with gas or liquid, a shape memory alloy responding to temperatures, a traction guide wire (23) penetrating the electrode body, etc. The ablation electrode generates active deformation under the active force applying effect of the force applying layer, so that the application requirements of irregular tumor conformal ablation are met, thereby improving the precision and safety of ablation treatment. The puncturing ablation needle can implement the adjustment of a puncturing depth, the planar change of a stretch angle, and the space deflection of the angle. Also disclosed is a puncturing ablation needle comprising the flexible ablation electrode having an active deformation function.

Description

Flexible ablation electrode with active deformation function and puncture ablation needle [Technical field]

The invention belongs to the field of medical instruments, and particularly relates to a flexible ablation electrode with an active deformation function and a puncture ablation needle.

[Background technique]

Prostate cancer and kidney cancer in urinary tumors have very high morbidity and mortality, and are diseases that seriously endanger human health. The incidence of prostate cancer accounts for 2 in the world, 9 in mortality, 11 in renal cancer, and 17 in mortality. In recent years, with the rapid development of China's social economy, the incidence of prostate cancer has increased. The trend is rising year by year, and it is close to European and American countries in economically developed areas such as Beijing and Shanghai. Percutaneous biopsy and percutaneous ablation are important techniques for the diagnosis and treatment of prostate cancer and renal cancer. Percutaneous biopsy is the gold standard for preoperative diagnosis of prostate cancer and renal cancer. Percutaneous ablation is less invasive and quicker. The advantages of recent years have received much attention, and have been listed as first-line treatment methods in Europe and the United States. Compared with manual puncture, percutaneous puncture can effectively improve the safety and effectiveness of surgery. Minimally invasive treatment of contemporary tumors follows three principles: tumor control, retention of organ function, and reduction of complications. Percutaneous ablation is also followed by these principles. When ablation of renal tumors, it is necessary to preserve normal kidney tissue and not to damage the adjacent blood vessels, collecting system and intestinal tube. When ablation of prostate cancer, try not to damage urethral sphincter, penile erectile nerve and rectum. Wait. Current ablation procedures take a long time and the ablation area is uncontrollable. For scattered small tumors, irregular tumors, in order to ensure the ablation effect on the tumor area, inevitably damage the normal tissue adjacent thereto.

Percutaneous surgical instruments have a wide range of applications in urinary surgery. Currently, ablation electrodes include tubular electrodes, polymer electrodes, electrodes having oblique surfaces, and the like. There are many types of puncture needles, including oblique needles, single-sided/double-sided pre-bent needles and combination needles. Relevant control methods include needle bottom end control, adjacent tissue external control and casing control. However, the trajectory of the ablation electrode inside the tissue is uncontrollable, and such devices cannot produce active deformation as needed during the surgical procedure to meet the application requirements of irregular tumor conformal ablation.

[Summary of the Invention]

In view of at least one of the above defects or improvement requirements of the prior art, the present invention provides a flexible ablation electrode with an active deformation function and a puncture ablation needle, which is particularly suitable for performing tumor ablation treatment, and the flexible ablation electrode can pass an ablation process. The adjustment of its own shape improves the conformity of irregular tumors and improves the accuracy and safety of ablation treatment.

In order to achieve the above object, according to an aspect of the invention, a flexible ablation electrode having an active deformation function, comprising a flexible coating layer, a force applying layer and a conductive ablation electrode body, the flexible coating layer and the force applying layer is provided. And the conductive ablation electrode body is arranged in order from the outside to the inside;

The flexible cover layer is composed of a flexible polymeric material;

The force applying layer includes a micro flow channel filled with a gas or a liquid, a shape memory alloy that responds to a temperature, and one of the traction guide wires penetrating the electrode body;

The electrode body is composed of a conductive material that is deformed with an external force and the external force disappears, and the electrode body is processed into a flat square shape.

Preferably, the urging layer comprises the traction guide wire, the fastening point and the plurality of collars penetrating through the electrode body; the traction guide wire is directly consolidated with the electrode body through the fastening point, The collar is disposed between the electrode body and the traction guide wire for limiting the swinging and deviation of the traction guide wire relative to the electrode body, and the traction guide wire passes through the electrode body. The small hole and the collar are inserted into the electrode body to form an integral structure.

Preferably, the force applying layer includes the traction guide wire penetrating through the electrode body, and a groove formed on the electrode body; and the groove is placed in parallel with the electrode body A guiding wire is formed through the small hole in the electrode body, and the groove is inserted into the electrode body to form an integral structure.

Preferably, the electrode body is composed of a titanium-based alloy material.

In order to achieve the above object, according to another aspect of the present invention, a puncture ablation needle is provided, comprising a flexible ablation electrode having an active deformation function, a rigid outer sheath, a connection module, a drive module and a adapter as described above;

The ablation electrode is a plurality of ablation electrodes having different lengths and thicknesses, and all ablation electrodes are wrapped by the rigid outer sheath, and a tail portion of the ablation electrode is connected to the driving module through the connection module, and the driving module And a power generator is connected through the adapter.

Preferably, the drive module is a drive motor.

Preferably, the plurality of said ablation electrodes are controlled in parallel by the same drive motor.

Preferably, the plurality of ablation electrodes are individually controlled by a drive motor.

Preferably, a plurality of said ablation electrodes are circumferentially distributed inside said rigid outer sheath.

Preferably, the puncture ablation needle is controlled by adjusting the depth of the puncture by axially pushing and pulling the ablation electrode tail to adjust the depth of the puncture; and adjusting the force of the traction guide wire by the driving module to adjust the The plane bending amplitude of the ablation electrode is used to achieve a change in the extension angle; the entire ablation electrode is returned to the rigid outer sheath, and the tail is controlled to be twisted to achieve angular deflection.

The above preferred technical features can be combined with each other as long as they do not constitute a conflict with each other.

In general, the above technical solutions conceived by the present invention have the following beneficial effects compared with the prior art:

1. The active acupressure of the ablation electrode is activated by the active force application of the force-applying layer, which satisfies the application requirements of the conformal ablation of the irregular tumor, and improves the accuracy and safety of the ablation treatment;

2. The ablation electrode is flexible in deformation, and can realize horizontal deflection, circumferential rotation, and axial movement before and after. The puncture ablation needle can realize the adjustment of the puncture depth, the plane change of the extension angle, and the spatial deflection of the angle.

[Description of the Drawings]

Figure 1 is a schematic view showing the structure of an ablation electrode;

2 is a schematic view showing the structure of an ablation electrode using a traction guide wire type;

Fig. 3 is a schematic view showing the overall structure of the puncture ablation needle.

[detailed description]

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. Further, the technical features involved in the various embodiments of the present invention described below may be combined with each other as long as they do not constitute a conflict with each other. The present invention will be further described in detail below in conjunction with specific embodiments.

As a preferred embodiment of the present invention, as shown in FIG. 1 , the present invention provides a flexible ablation electrode having an active deformation function, including a flexible covering layer 1 , a force applying layer 2 and a conductive ablation electrode body 3 . The flexible covering layer 1, the force applying layer 2 and the conductive ablation electrode body 3 are sequentially disposed from the outside to the inside.

The flexible coating layer 1 is composed of a flexible polymer material; the wrapping of the electrode surface by the flexible polymer can effectively block the influence of the liquid inside the human body on the electrode portion and ensure the electrical stability thereof; The designed active deformation drive structure is effectively wrapped, and the filling of the titanium-based alloy electrode forms a smooth surface to reduce the resistance during the puncture. The coating material used has certain heat resistance and deformation followability, and can withstand the heat generated during the operation of the electrode or the bending of the electrode without cracking.

The force applying layer 2 functions as an active force applying portion, and includes various modes including, but not limited to, a liquid-filled micro-channel (adjusting gas/liquid pressure to force the electrode to deform), a shape memory alloy that follows the temperature response, A traction guide wire that penetrates the electrode body (forces deformation of the electrode by traction of the guide wire) and the like.

The electrode body 3 is composed of a conductive material having moderate rigidity (that is, deformation can be generated by an external force and capable of returning to the original shape when the external force disappears), including a tough metal (titanium, steel, etc.), a semiconductor material, a composite material, and the like. Preferably, the metal electrode processed by the titanium-based alloy material is the body of the ablation electrode, and the initial pre-bending deformation is generated under the force of the high Young's modulus, and the titanium-based alloy is used for the conductive heating to generate the ablation process. Temperature field.

The electrode body 3 processed by the titanium-based alloy material is formed into a flat square shape to ensure stability during bending.

Referring to FIG. 2 , preferably, in the traction guide wire type, the force applying layer 2 includes the traction guide wire 23 , the fastening point 21 , and the plurality of collars 22 running through the electrode body 3 ; The guiding wire 23 is directly consolidated with the electrode body 3 through the fixing point 21, and the collar 22 is disposed between the electrode body 3 and the traction wire 23 for limiting the traction wire 23 With respect to the swinging and deviation of the electrode body 3, the traction guide wire 23 passes through the small hole in the electrode body 3, and the collar 22 is inserted into the electrode body 3 to form an integral structure. The traction guide wire 23 and the electrode body 3 are limited in their excess freedom by the collar 22.

As an alternative, the urging layer 2 may further include a traction guide wire 23 penetrating through the electrode body 3, and a groove formed on the electrode body 3 processed by a micromachining process; The same purpose can also be achieved by placing one of the traction guide wires 23 (specifically, nylon or high-strength steel wire, which is about several hundred micrometers in diameter) in parallel with the electrode body 3 in the groove. The wire 23 is inserted into the electrode body 3 through a small hole in the electrode body 3 to form an integral structure. The length of the traction guide wire and the number of fixation holes are determined by the magnitude of the electrode deformation required. Finally, the surface is encapsulated with a flexible polymer to form a smooth, flat surface.

The invention provides a flexible ablation electrode with active deformation function, which is particularly suitable for performing tumor ablation treatment, and the flexible ablation electrode can actively deform the ablation electrode through the active force application of the force-applying layer to satisfy the irregular tumor ablation. The application requirements increase the accuracy and safety of ablation treatment.

Referring to Figure 3, in order to achieve the above object, in accordance with another aspect of the present invention, there is also provided a puncture ablation needle comprising a flexible ablation electrode having an active deformation function as described above, a rigid outer sheath 50 (having an axis 60) , the connection module 70, the drive module 80 and the adapter 90.

The ablation electrode is a plurality of ablation electrodes 10, 20, 30, 40 having different lengths and thicknesses (illustrated by four examples), and the number of specific electrodes can be selected according to treatment needs. All of the ablation electrodes 10, 20, 30, 40 are wrapped by a rigid outer sheath 50 having a diameter of no more than 3 cm, and a plurality of said ablation electrodes 10, 20, 30, 40 are circumferentially distributed inside said rigid outer sheath 50. The tail portions of the ablation electrodes 10, 20, 30, 40 are connected to the driving module 80 (including but not limited to a motor and an electrode) through the connection module 70, and a plurality of electrodes may be connected in parallel by the same driving motor. It is also possible to adopt separate control methods; at the same time, the drive module 80 and the power generator are connected via the adapter 90.

The aforementioned ablation electrodes can achieve three modes of motion: horizontal deflection, circumferential rotation, and axial movement before and after. Correspondingly, the method for controlling the puncture ablation needle is to realize the back and forth movement by axially pushing and pulling the tail portions of the ablation electrodes 10, 20, 30, 40 to adjust the depth of the puncture; and the driving module 80 controls the The force of the traction guide wire 23 adjusts the plane bending amplitude of the ablation electrodes 10, 20, 30, 40 to achieve a change in the extension angle; the entire ablation electrode 10, 20, 30, 40 is retracted back to the rigid outer sheath 50 , control the tail to twist, to achieve the deflection of the angle.

The puncture ablation needle provided by the invention has the function of active deformation and flexible deformation, and can realize horizontal deflection, circumferential rotation, axial movement before and after, and the puncture ablation needle can realize the adjustment and extension of the puncture depth. The plane change of angle and the spatial deflection of angle are especially suitable for tumor ablation treatment, satisfying the application requirements of irregular tumor conformal ablation, and improving the accuracy and safety of ablation treatment.

Those skilled in the art will appreciate that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and scope of the present invention, All should be included in the scope of protection of the present invention.

Claims (10)

A flexible ablation electrode having an active deformation function, comprising: a flexible coating layer (1), a force applying layer (2) and a conductive ablation electrode body (3), the flexible coating layer (1), The force layer (2) and the conductive ablation electrode body (3) are sequentially disposed from the outside to the inside; The flexible cover layer (1) is composed of a flexible polymer material; The force applying layer (2) includes a micro-flow channel filled with gas or liquid, a shape memory alloy that responds to temperature, and one of the traction wires (23) penetrating the electrode body (3); The electrode body (3) is composed of a conductive material that is deformed with an external force and the external force disappears, and the electrode body (3) is processed into a flat square shape. The flexible ablation electrode with active deformation function according to claim 1, wherein the force applying layer (2) comprises the traction guide wire (23) and the fastening point penetrating through the electrode body (3) (21) a plurality of collars (22); the traction guide wire (23) is directly consolidated with the electrode body (3) through the fixing point (21), and the collar (22) is disposed at the Between the electrode body (3) and the traction wire (23) for limiting the swinging and deviation of the traction wire (23) relative to the electrode body (3), the traction wire (23) Through the small hole in the electrode body (3), the collar (22) is inserted into the electrode body (3) to form an integral structure. The flexible ablation electrode with active deformation function according to claim 1, wherein the urging layer (2) comprises the traction guide wire (23) penetrating through the electrode body (3), formed on a groove on the electrode body (3); in the groove, a traction guide wire (23) is placed in parallel with the electrode body (3), and the traction guide wire (23) passes through the electrode A small hole in the body (3), the groove is inserted into the electrode body (3) to form an integral structure. The flexible ablation electrode with active deformation function according to any one of claims 1 to 3, characterized in that the electrode body (3) is composed of a titanium-based alloy material. A puncture ablation needle, comprising the flexible ablation electrode with active deformation function according to any one of claims 2-4, a rigid outer sheath (50), a connection module (70), and a driving module (80) And adapter (90); The ablation electrode is a plurality of ablation electrodes (10, 20, 30, 40) having different lengths and thicknesses, and all of the ablation electrodes (10, 20, 30, 40) are wrapped by the rigid sheath (50). The tail of the ablation electrode (10, 20, 30, 40) is connected to the drive module (80) through the connection module (70), while the drive module (80) and the power generator pass through the adapter (90) )connection. A flexible ablation electrode having an active deformation function according to claim 5, wherein said drive module (80) is a drive motor. A puncture ablation needle according to claim 6, wherein a plurality of said ablation electrodes (10, 20, 30, 40) are controlled in parallel by the same drive motor. A puncture ablation needle according to claim 6, wherein a plurality of said ablation electrodes (10, 20, 30, 40) are individually controlled by a drive motor. A puncture ablation needle according to claim 5, wherein a plurality of said ablation electrodes (10, 20, 30, 40) are circumferentially distributed inside said rigid outer sheath (50). The puncture ablation needle according to claim 5, wherein the puncture ablation needle is controlled by means of axially pushing and pulling the tail of the ablation electrode (10, 20, 30, 40) to achieve forward and backward movement. Adjusting the depth of the puncture; controlling the force of the traction wire (23) by the driving module (80) to adjust the plane bending amplitude of the ablation electrode (10, 20, 30, 40) to achieve a change in the stretching angle; The entire ablation electrode (10, 20, 30, 40) is retracted to the rigid outer sheath (50) and its tail is controlled to be twisted to achieve angular deflection.

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