Endometrial ablation system

Abstract

An endometrium ablation system comprises an ablation gun, the ablation gun comprises an ablation probe, the ablation probe comprises a probe tube and expansion wires made of elastic memory metal, an expandable air bag is arranged between the two expansion wires, controllable heating units are arranged on the outer side of the expandable air bag, the number of the heating units is multiple, and the number of the heating units is multiple. And a plurality of heating units are uniformly distributed on the local surface of the inflatable air bag at least in the expanded state. The endometrium heating device is provided with the inflatable air bag, the multiple heating units capable of being independently controlled for heating are arranged on the outer side face of the inflatable air bag, after the inflatable air bag is inflated, the heating units make full contact with the endometrium, and under the assistance of B ultrasound, one or more specific heating units can be controlled for heating; according to the invention, the position of the ablation probe in the uterus is not required to be adjusted, the treatment of an endometrial focus area can be realized, the structure design is reasonable, micro-operation is not required, the use is simple, and the uterus can be protected to the greatest extent.

Description

Technical Field

[0001] This invention belongs to the technical field of endometrial ablation equipment, and more specifically, relates to an endometrial ablation system. Background Technology

[0002] Endometrial ablation is used to treat menorrhagia or other uterine diseases. In existing technologies, endometrial ablation generally employs a radiofrequency current approach. This approach requires an ablation gun with an ablation probe at its tip. The probe is inserted into the uterus through the cervix. Then, under ultrasound guidance, the probe is opened and radiofrequency current is applied to a localized area of ​​the endometrium, causing local denaturation and thus eliminating the lesion.

[0003] Currently, ablation probes can only apply radiofrequency current heating to local areas of the endometrium. If there are multiple lesions in the uterus or the lesion area is large, it is necessary to manually control the ablation gun outside the body to adjust the position of the ablation probe in the uterus. This not only requires a high level of micromanagement skills, but if the movement is too large, it can also damage the cervix. Summary of the Invention

[0004] (I) Technical Issues

[0005] In summary, how to provide a novel ablation probe structure that covers the entire endometrial area and achieves treatment of endometrial lesions without adjusting the ablation probe has become an urgent problem to be solved by those skilled in the art.

[0006] (II) Technical Solution

[0007] This invention provides an endometrial ablation system, including an ablation gun, which includes an ablation probe. In this invention, the ablation probe of the endometrial ablation system includes a probe tube and two expansion wires made of elastic shape memory metal. The two expansion wires are symmetrically arranged and can slide relative to the probe tube, and can slide out or retract relative to the probe tube. After the expansion wire slides out of the probe tube, the two expansion wires can form a gradually expanding structure.

[0008] An inflatable airbag is disposed between the two expansion wires, and a controllable heating unit is disposed on the outside of the inflatable airbag. Multiple heating units are disposed, and at least multiple heating units are evenly distributed on a local surface of the inflatable airbag in the inflated state. Each heating unit is connected to an external control device via a thin wire to achieve independent control of a specific heating unit. An air supply system is connected to the inflatable airbag for inflating the inflatable airbag.

[0009] Preferably, in the endometrial ablation system provided by the present invention, the probe tube is a rectangular tube structure, the probe tube includes two oppositely arranged wide sidewalls and two oppositely arranged long sidewalls, and a limiting structure is provided inside the probe tube and relative to the wide sidewalls. The limiting structure is a limiting groove or a limiting ring. A slide rod is provided through the limiting structure, one end of the slide rod is connected to the expansion wire, and the other end of the slide rod is provided with an annular slide. The ablation gun is also provided with a linear motor, the linear motor is poweredly connected to the annular slide, and is used to drive the reciprocating sliding of the annular slide.

[0010] Preferably, in the endometrial ablation system provided by the present invention, the expandable balloon is provided with five balloon units, namely one top balloon unit, two side balloon units, and two sidewall balloon units; the top balloon unit is a strip-shaped balloon structure, which is disposed at the top end of the expansion wire and connected to the two expansion wires; the sidewall balloon units are strip-shaped balloon structures, which are respectively disposed on the two expansion wires and arranged along the length direction of the expansion wires; the side balloon units are ginkgo leaf-shaped balloon structures, which are respectively disposed on both sides of the plane where the two expansion wires are located; the five balloon structures can be independently controlled for inflation.

[0011] Preferably, in the endometrial ablation system provided by the present invention, the heating unit includes a heating wire and a heating plate, the heating wire is disposed on the top airbag unit and the side wall airbag unit, and the heating plate is disposed on the side airbag unit.

[0012] Preferably, in the endometrial ablation system provided by the present invention, the heating element has a fish-scale structure.

[0013] Based on the above preferred method, in the endometrial ablation system provided by the present invention, the heating pads disposed on the same side balloon unit are spaced apart.

[0014] Alternatively, based on the above preferred method, in the endometrial ablation system provided by the present invention, the heating pads disposed on the same side balloon unit are in lateral contact.

[0015] Alternatively, based on the above preferred method, in the endometrial ablation system provided by the present invention, the heating pads arranged on the same side balloon unit are arranged such that, in the direction of extension of the expansion wire, the upper layer of the heating pads covers the lower layer of the heating pads.

[0016] Preferably, in the endometrial ablation system provided by the present invention, in the two overlapping heating pads, the coverage area of ​​the previous heating pad over the next heating pad does not exceed one-third of the area of ​​the next heating pad.

[0017] Preferably, in the endometrial ablation system provided by the present invention, a roller is provided on the inner side of the top of the long sidewall for rolling and pressing the heating plate during the retraction of the expansion wire.

[0018] Preferably, in the endometrial ablation system provided by the present invention, the probe tube is a ceramic tube, a titanium tube, or a titanium alloy tube.

[0019] Preferably, in the endometrial ablation system provided by the present invention, the heating unit is made of titanium alloy.

[0020] Preferably, in the endometrial ablation system provided by the present invention, the gas supply system is an inert gas supply system.

[0021] (III) Beneficial Effects

[0022] As described above, the present invention provides an endometrial ablation system, including an ablation gun, which includes an ablation probe. The ablation probe includes a probe tube and an expansion wire made of elastic memory metal. Two expansion wires are provided, symmetrically arranged. The expansion wires can slide relative to the probe tube and can slide out or retract relative to the probe tube. After the expansion wire slides out of the probe tube, the two expansion wires can form a gradually expanding structure. An inflatable airbag is provided between the two expansion wires. A controllable heating unit is provided on the outside of the inflatable airbag. Multiple heating units are provided, and at least a plurality of heating units are evenly distributed on a local surface of the inflatable airbag in the inflated state. Each heating unit is connected to an external control device via a thin wire to achieve independent control of a specific heating unit. An air supply system is connected to the inflatable airbag for inflating the inflatable airbag.

[0023] Through the above structural design, the endometrial ablation system provided by this invention has two innovative features: 1. It is equipped with an expandable balloon, which inflates within the uterine cavity, ensuring maximum contact between the balloon and the endometrium; 2. Multiple independently controllable heating units are located on the outer surface of the expandable balloon. After inflation, the heating units fully contact the endometrium. With ultrasound assistance, one or more specific heating units can be controlled for heating without adjusting the position of the ablation probe within the uterus. This invention employs a novel ablation probe structure. After insertion into the uterine cavity, the heating units can cover the entire endometrial area, enabling treatment of endometrial lesions without adjusting the ablation probe. The invention has a reasonable structural design, requires no micromanipulation, is simple to use, and maximizes uterine protection. Attached Figure Description

[0024] Figure 1 This is a simplified structural diagram of an endometrial ablation system in one embodiment of the present invention.

[0025] exist Figure 1 In the diagram, the correspondence between component names and reference numerals is as follows:

[0026] 1. Ablation gun; 2. Probe tube; 3. Expansion wire; 4. Slide rod; 5. Circular carriage; 6. Linear motor.

[0027] Top airbag unit 7, side airbag unit 8, side wall airbag unit 9, heating element 10, rollers 11.

[0028] Control unit 12, power supply 13. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0030] Furthermore, in the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0031] Please refer to Figure 1 ,in, Figure 1 This is a simplified structural diagram of an endometrial ablation system in one embodiment of the present invention.

[0032] This invention provides an endometrial ablation system, including an ablation gun 1. The overall structure of the ablation gun 1 is similar to that of a traditional ablation gun, including a handle (for the operator to hold), a barrel (the barrel is a tubular structure with a diameter between 0.8cm and 1.5cm; in traditional designs, the barrel is a rectangular structure, while in this invention, the barrel is a rectangular tube; in this invention, the cross-sectional length of the barrel is between 0.8cm and 1.2cm, and the width is between 0.5cm and 0.8cm), and an ablation probe is provided at the front end of the barrel, which is a tubular component.

[0033] The ablation gun 1 includes an ablation probe, which comprises a probe tube 2 and an expansion wire 3 made of elastic shape memory metal. The diameter of the expansion wire 3 is between 0.05cm and 0.1cm, with a smaller diameter being preferable. When the expansion wire 3 has a diameter of 0.05cm, two or three expansion wires 3 are provided on one side, and they are connected in parallel. There are two expansion wires 3 (specifically, two sets of expansion wires 3), symmetrically arranged. When the gun barrel is a rectangular tube structure, the probe tube 2 is also a rectangular tube structure, with the same cross-sectional shape and dimensions as the gun barrel. Two sets of expansion wires 3 are provided, each set positioned on the wide side of the probe tube 2. The expansion wires 3 can slide relative to the probe tube 2 and can slide out or retract relative to it. In this invention, a clamping structure is provided on the inner wall of the probe tube 2, and the expansion wires 3 are fitted within this clamping structure. The clamping structure limits the sliding of the expansion wires 3, preventing them from deviating from their designated path. After the expansion wires 3 slide out of the probe tube 2, the two expansion wires 3 can form a gradually expanding structure. Because the expansion wires 3 are made of shape memory metal, after sliding out of the probe tube 2 and losing the constraint of the probe tube 2, they can return to their original structural state. The expansion wires 3 form the aforementioned gradually expanding structure through their own elasticity. In one embodiment of this invention, after the two sets of expansion wires 3 slide out of the probe tube 2, they can form an elastic frame that approximates the outline of a ginkgo leaf. The dimensions of this elastic frame are a maximum width of 4.5cm-6cm and a maximum height of 4.5cm-6cm. In the above structural design, the elastic frame formed by the expansion wire 3 has a variety of size types. After confirming the approximate size of the patient's uterine cavity by ultrasound before the operation, an elastic frame that is similar to but smaller than the size of the patient's uterine cavity is selected.

[0034] The female uterine cavity has a certain space. The elastic frame composed of expansion wires 3 is placed in the uterine cavity as a planar structure. In order to maintain sufficient contact with the endometrium in the uterine cavity, the present invention provides an expandable airbag between the two expansion wires 3. Before the ablation probe is inserted into the uterine cavity, the expansion wires 3 and the expandable airbag (and the heating unit set on the expandable airbag) are stored in the probe tube 2. Since the diameter of the probe tube 2 is small, in order to ensure that the above structure can be smoothly retracted into the probe tube 2 after use, the expansion wires 3, the expandable airbag and the heating unit should be as small as possible in size and thickness under the existing technical conditions. A controllable heating unit, made of metal, is located on the outside of the inflatable airbag. A conductive wire is installed inside the inflatable airbag and can be attached to the inner surface of the airbag with flexible adhesive. One end of the conductive wire has a connector for connection to the control unit 12 or the power supply 13. The other end of the conductive wire passes through the inflatable airbag and connects to the heating unit. When energized, the heating unit acts as a resistor, converting electrical energy into heat energy. When the heating unit comes into contact with the endometrium, the heat generated causes dehydration of the endometrial cells and denaturation of proteins, thereby achieving endometrial ablation. Adhesive is used to ensure airtightness between the conductive wire and the inflatable airbag. The adhesive also allows for the fixation of a local structure of the heating unit (the area of ​​the local structure does not exceed half the area of ​​the heating unit, allowing the inflatable airbag to contract or elastically compress when it is retracted into the probe tube 2, ensuring smooth retraction) to the inflatable airbag.

[0035] The heating unit is provided in multiple ways. At least in the inflatable airbag in the inflated state, multiple heating units are evenly distributed on a local surface. Each heating unit is connected to an external control device through a thin wire to achieve independent control of a specific heating unit. It is connected to an air supply system for inflating the airbag.

[0036] In this invention, multiple inflatable airbags are provided. Each inflatable airbag consists of two elastic airbag membranes. First, the airbag membranes are cut according to the outline shape of the inflatable airbag. Then, a thin wire is fixed to the inner side of the airbag membrane with flexible adhesive. After the thin wire passes through the airbag membrane, a heating unit is provided on the outer side of the airbag membrane. An adhesive layer is provided, avoiding the connection between the heating unit and the thin wire. The adhesive layer surrounds the connection between the heating unit and the thin wire, and the heating unit is welded to the thin wire. At the same time, the heating unit is fixedly connected to the outer side of the airbag membrane through the adhesive layer. Of course, the thin wire can also pierce the adhesive layer to connect to the heating unit. When the adhesive layer is made of conductive adhesive, the welding operation between the heating unit and the thin wire can be omitted.

[0037] Specifically, the probe tube 2 has a rectangular tube structure, including two oppositely arranged wide sidewalls and two oppositely arranged long sidewalls. A limiting structure, such as a limiting groove or a limiting ring, is provided inside the probe tube 2 relative to the wide sidewalls. A slide rod 4 is provided through the limiting structure, with an expansion wire 3 connected to one end of the slide rod 4 and an annular slide 5 at the other end. The ablation gun 1 also includes a linear motor 6, which is poweredly connected to the annular slide 5 and used to drive the reciprocating sliding of the annular slide 5. In the prior art, any structure capable of driving the reciprocating movement of the expansion wire 3 can be applied to this invention.

[0038] Specifically, the inflatable airbag has five airbag units: one top airbag unit 7, two side airbag units 8, and two sidewall airbag units 9. The top airbag unit 7 is a strip-shaped airbag structure, located at the top of the expansion wire 3 and connected to the two expansion wires 3. The sidewall airbag units 9 are strip-shaped airbag structures, each located on one of the two expansion wires 3 and along the length of the expansion wire 3. The side airbag units 8 are ginkgo leaf-shaped airbag structures, each located on one side of the plane containing the two expansion wires 3. The five airbag structures can be independently controlled for inflation. Based on the above-mentioned structural design of the inflatable airbag, the heating unit has also been structurally optimized: the heating unit includes a heating wire and a heating plate 10. The heating wire is located on the top airbag unit 7 and the sidewall airbag units 9, and the heating plate 10 is located on the side airbag units 8. Further, the heating plate 10 has a fish-scale structure, meaning that the outline shape and spatial structure of the heating plate 10 are similar to a fish-scale structure, but its size is smaller. Heating pads 10 are disposed on the side airbag units 8. When the side wall units are deployed and not inflated, they can be considered as a planar structure, with the heating pads 10 evenly distributed on the side airbag units 8. The heating pads 10 on the side airbag units 8 have three distribution patterns: 1. Heating pads 10 on the same side airbag unit 8 are spaced apart; 2. Heating pads 10 on the same side airbag unit 8 are in lateral contact; 3. On the same side airbag unit 8, in the direction of the expansion wire 3, the heating pads 10 of the upper layer cover the heating pads 10 of the lower layer. Among these three distribution patterns, the first and third patterns are preferred. For the first distribution pattern, the size of the heating pads 10 can be slightly larger, and the number of heating pads 10 can be reduced, making it suitable for patients with larger lesions or for performing complete endometrial ablation. For the third setting method, the size of the heating pad 10 is smaller, the number of heating pads 10 is more and they are more densely arranged. This method is suitable for patients with small lesions and irregular outlines. Of course, the third setting method is also suitable for performing complete endometrial ablation.

[0039] Multiple heating elements 10 are arranged in a regular matrix, and each heating element 10 can be powered by two separate thin wires. When there are multiple heating units, there are also multiple thin wires (the number of thin wires is twice the number of heating units). This requires the setting of corresponding interface devices and control systems to achieve precise control of each heating unit. This is a conventional design for existing electromechanical designs and will not be elaborated here.

[0040] Specifically, in the two overlapping heating elements 10, the area covered by the previous heating element to the next heating element does not exceed one-third of the area of ​​the next heating element. This avoids the situation where the coverage area is too large and the heat is too concentrated.

[0041] To facilitate the storage of the inflatable airbag, the present invention provides a roller 11 on the inner side of the top of the long side wall, which is used to roll and press down the heating element 10 during the retraction of the expansion wire 3, so as to prevent the heating element 10 from getting stuck on the probe tube 2.

[0042] In this invention, when the probe tube 2 passes through the cervix, in order to avoid the tip of the probe tube 2 causing damage to the cervix, the probe tube 2 is designed with a certain inward structure, which is equivalent to a micro-constriction structure, making it easier for the probe tube 2 to pass through the cervix.

[0043] Specifically, probe tube 2 is a ceramic tube, a titanium tube, or a titanium alloy tube.

[0044] Specifically, the heating unit is made of titanium alloy.

[0045] Specifically, the gas supply system is an inert gas supply system.

[0046] As described above, the present invention provides an endometrial ablation system, including an ablation gun 1, which includes an ablation probe, a probe tube 2, and an expansion wire 3 made of elastic memory metal. Two expansion wires 3 are provided, symmetrically arranged, and can slide relative to the probe tube 2 and can slide out or retract relative to the probe tube 2. After the expansion wire 3 slides out of the probe tube 2, the two expansion wires 3 can form a gradually expanding structure. An inflatable airbag is provided between the two expansion wires 3, and a controllable heating unit is provided on the outside of the inflatable airbag. Multiple heating units are provided, with multiple heating units evenly distributed on a local surface of the inflatable airbag in the inflated state. Each heating unit is connected to an external control device via a thin wire to achieve independent control of a specific heating unit. An air supply system is connected to the inflatable airbag for inflating the inflatable airbag.

[0047] Through the above structural design, the endometrial ablation system provided by this invention has two innovative features: 1. It is equipped with an expandable balloon, which inflates within the uterine cavity, ensuring maximum contact between the balloon and the endometrium; 2. Multiple independently controllable heating units are located on the outer surface of the expandable balloon. After inflation, the heating units fully contact the endometrium. With ultrasound assistance, one or more specific heating units can be controlled for heating without adjusting the position of the ablation probe within the uterus. This invention employs a novel ablation probe structure. After insertion into the uterine cavity, the heating units can cover the entire endometrial area, enabling treatment of endometrial lesions without adjusting the ablation probe. The invention has a reasonable structural design, requires no micromanipulation, is simple to use, and maximizes uterine protection.

[0048] As is known from common technical knowledge, this invention can be implemented through other embodiments that do not depart from its spirit or essential characteristics. Therefore, the disclosed embodiments described above are merely illustrative in all respects and are not the only ones. All modifications within the scope of this invention or its equivalents are included in this invention.

Claims

1. An endometrial ablation system, comprising an ablation gun (1), said ablation gun including an ablation probe, characterized in that, The ablation probe includes a probe tube (2) and an expansion wire (3) made of elastic memory metal. There are two expansion wires, which are symmetrically arranged. The expansion wires can slide relative to the probe tube and can slide out or retract relative to the probe tube. After the expansion wire slides out of the probe tube, the two expansion wires can form a gradually expanding structure. An inflatable airbag is disposed between the two expansion wires, and a controllable heating unit is disposed on the outside of the inflatable airbag. Multiple heating units are disposed, and at least multiple heating units are evenly distributed on a local surface of the inflatable airbag in the inflated state. Each heating unit is connected to an external control device via a thin wire to achieve independent control of a specific heating unit. An air supply system is connected to the inflatable airbag for inflating the inflatable airbag.

2. The endometrial ablation system according to claim 1, characterized in that, The probe tube is a rectangular tube structure. The probe tube includes two oppositely arranged wide sidewalls and two oppositely arranged long sidewalls. A limiting structure is provided inside the probe tube and relative to the wide sidewalls. The limiting structure is a limiting groove or a limiting ring. A slide rod (4) is provided through the limiting structure. One end of the slide rod is connected to the expansion wire, and the other end of the slide rod is provided with an annular slide (5). The ablation gun is also equipped with a linear motor (6), which is poweredly connected to the annular slide and is used to drive the reciprocating sliding of the annular slide.

3. The endometrial ablation system according to claim 2, characterized in that, The inflatable airbag is provided with five airbag units, namely a top airbag unit (7), two side airbag units (8) and two side wall airbag units (9); The top airbag unit is a strip-shaped airbag structure, and the top airbag unit is disposed at the top end of the expansion wire and connected to the two expansion wires; The sidewall airbag unit is a strip-shaped airbag structure, and the two sidewall airbag units are respectively disposed on the two expansion wires and arranged along the length direction of the expansion wires; The side airbag unit is a ginkgo leaf-shaped airbag structure, and the two side airbag units are respectively disposed on both sides of the plane where the two expansion wires are located. The five airbag structures can be independently controlled for inflation.

4. The endometrial ablation system according to claim 3, characterized in that, The heating unit includes a heating wire and a heating plate (10). The heating wire is disposed on the top airbag unit and the side wall airbag unit, and the heating plate is disposed on the side airbag unit.

5. The endometrial ablation system according to claim 4, characterized in that, The heating element has a fish scale structure; The heating elements disposed on the same side airbag unit are spaced apart; Alternatively, the heating elements disposed on the same side airbag unit may make side contact with each other; Alternatively, the heating element disposed on the same side airbag unit may have an upper heating element covering the lower heating element in the direction of extension of the expansion wire.

6. The endometrial ablation system according to claim 5, characterized in that, In the case of two overlapping heating elements, the area covered by the previous heating element on the next heating element shall not exceed one-third of the area of ​​the next heating element.

7. The endometrial ablation system according to claim 6, characterized in that, A roller (11) is provided on the inner side of the top of the long sidewall for rolling and pressing the heating element during the retraction of the expansion wire.

8. The endometrial ablation system according to claim 7, characterized in that, The probe tube is a ceramic tube, a titanium tube, or a titanium alloy tube.

9. The endometrial ablation system according to claim 8, characterized in that, The heating unit is made of titanium alloy.

10. The endometrial ablation system according to claim 9, characterized in that, The gas supply system is an inert gas supply system.

Images