A device for ablation therapy of the digestive tract and a system comprising the same

Abstract

A device for ablation treatment of digestive tract and a system comprising the same, comprising: a middle catheter; an outer catheter, the middle catheter being rotatably arranged relative to the outer catheter; a balloon having a contracted state and an expanded state, the balloon being sleeved on a distal end portion of the middle catheter, and an inner side of the balloon being fixedly connected with the distal end portion of the middle catheter; a medium channel extending along a length direction of the middle catheter or the outer catheter, a distal end of the medium channel being in communication with the balloon; an electrode film being spirally wound outside the balloon in a vortex shape, an inner end portion of the electrode film being connected to an outer side of the balloon, and an outer end portion of the electrode film being connected with a distal end portion of the outer catheter through a connector; in a forward rotation process of the middle catheter relative to the outer catheter, the middle catheter drives the balloon to rotate forward, the number of turns of the electrode film gradually decreases and the diameter of the electrode film gradually increases, the balloon is in the expanded state and supports the electrode film outward; in a reverse rotation process of the middle catheter relative to the outer catheter, the middle catheter drives the balloon to rotate reversely, the number of turns of the electrode film gradually increases and the diameter of the electrode film gradually decreases, and the balloon is in the contracted state.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a device and system comprising ablation therapy of the digestive tract. Background Technology

[0002] In the prior art, CN104546118B discloses an ablation device, including an expansion member and an ablation structure disposed outside the expansion member. The ablation structure has a fixed end disposed inside and a free end disposed outside. When the expansion member expands, the ablation structure expands accordingly. However, since its free end is disposed outside, when the ablation device moves inside the human body or when ablation is performed on a target location, the free end is prone to deflection, affecting the effectiveness of the device.

[0003] Therefore, how to design a device that is easy to operate and highly reliable for ablation treatment of the digestive tract is a goal explored by those skilled in the art. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an apparatus and system for ablation therapy of the digestive tract, wherein the morphology of the electrode membrane remains stable during ablation therapy.

[0005] To solve the above technical problems, the technical solution adopted in the first aspect of the present invention is as follows: A device for ablation therapy of the digestive tract, comprising: Slender central duct; A slender outer conduit is sleeved outside the middle conduit, and the middle conduit is rotatably disposed relative to the outer conduit; A balloon, having a contracted state where its radial diameter decreases after media outflow and an expanded state where its radial diameter increases after media injection, is fitted over and surrounds the distal end of the central catheter, and the inner side of the balloon is fixedly connected to the distal end of the central catheter. The medium channel extends along the length of the middle or outer catheter, the distal end of the medium channel is connected to the balloon, and the proximal end of the medium channel is connected to a medium pressure source. An electrode membrane is provided with multiple electrodes for receiving electrical signals. The electrode membrane is spirally wound around the outside of the balloon. The inner end of the electrode membrane is connected to the outside of the balloon, and the outer end of the electrode membrane is connected to the distal end of the external catheter through a connector. During the forward rotation of the middle catheter relative to the outer catheter, the middle catheter also drives the balloon to rotate in the forward direction. As a result, the number of turns of the electrode membrane gradually decreases and its diameter increases. The balloon is in a radially expanding state and radially outwards supports the electrode membrane. During the reverse rotation of the middle catheter relative to the outer catheter, the middle catheter also drives the balloon to rotate in the reverse direction. As a result, the number of turns of the electrode membrane gradually increases and its diameter decreases. The balloon is in a radially shrinking contraction state.

[0006] In some embodiments, the connector includes a first connecting rod and a second connecting rod, the first connecting rod being fixedly connected to the outer end of the electrode membrane, one end of the second connecting rod being pivotally connected to the distal end of the external conduit, and the other end of the second connecting rod being pivotally connected to the first connecting rod.

[0007] In some embodiments, the rear end of the second connecting rod is pivotally connected to the distal end of the outer conduit, and the front end of the second connecting rod is pivotally connected to the rear end of the first connecting rod, wherein the axis of the pivot is perpendicular to the axis of the middle conduit.

[0008] In some embodiments, during the reverse rotation of the middle catheter relative to the outer catheter, the balloon is in a radially shrinking contraction state and the electrode membrane clamps the balloon.

[0009] In some embodiments, a medium channel extending along the length of the middle conduit is provided between the middle conduit and the outer conduit.

[0010] In some embodiments, an inner catheter is also fixedly inserted into the lumen of the middle catheter, and the interlayer between the inner catheter and the middle catheter forms a medium channel.

[0011] In some embodiments, an actuator is connected to the proximal end of the middle catheter and the outer catheter, the actuator being used to drive the middle catheter to rotate forward or backward relative to the outer catheter.

[0012] In some embodiments, when the balloon is in the inflated state, the balloon is attached to the inside of all the innermost electrode membranes, and the front part of the balloon protrudes forward beyond the front side of the electrode membrane, and the rear part of the balloon protrudes backward beyond the rear side of the electrode membrane.

[0013] The technical solution adopted in the second aspect of this invention is as follows: A system for ablation therapy of the digestive tract, comprising the apparatus for ablation therapy of the digestive tract as described above, and further comprising: A signal generator configured to generate an electrical signal for treatment and electrically connected to the electrodes of the electrode membrane.

[0014] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: The device for ablation treatment of the digestive tract in this invention is configured such that the outer end of the electrode membrane is connected to the outer catheter via a connector, and the inner end of the electrode membrane is fixed to the middle catheter. The middle catheter can rotate relative to the outer catheter, thereby causing the balloon to rotate as well. On the one hand, this ensures the expansion function of the electrode membrane. On the other hand, during the movement or ablation of the device in the human body, the outer end of the electrode membrane remains relatively fixed and will not deviate. Furthermore, during the expansion or contraction of the electrode membrane, the rotation of the electrode membrane occurs at the inner end of the electrode membrane, and the rotation between the outermost layer of the electrode membrane and the inner wall of the digestive tract is minimal or nonexistent, resulting in minimal damage to the inner wall of the digestive tract. Attached Figure Description

[0015] Figure 1 This is a three-dimensional schematic diagram of an apparatus for ablation treatment of the digestive tract provided as an exemplary embodiment of the present invention, wherein the balloon is in an inflated state; Figure 2 This is a three-dimensional schematic diagram of an apparatus for ablation treatment of the digestive tract provided as an exemplary embodiment of the present invention, wherein the balloon is in a contracted state. Figure 3 This is a front view of an apparatus for ablation therapy of the digestive tract provided as an exemplary embodiment of the present invention, in which the balloon is in an inflated state; Figure 4 A side view of an apparatus for ablation therapy of the digestive tract provided as an exemplary embodiment of the present invention, wherein the balloon is in an inflated state; Figure 5 for Figure 4 A cross-sectional view along the AA direction; Figure 6 for Figure 5 Enlarged view of section C; Figure 7 for Figure 5 Enlarged sectional view along the EE direction; Figure 8 This is a front view of an apparatus for ablation therapy of the digestive tract provided as an exemplary embodiment of the present invention, in which the balloon is in a contracted state; Figure 9 This is a side view of an apparatus for ablation therapy of the digestive tract provided as an exemplary embodiment of the present invention, in which the balloon is in a contracted state; Figure 10 for Figure 9 A cross-sectional view along the BB direction; Figure 11 for Figure 10 Enlarged view of section D; Figure 12 for Figure 10 Enlarged cross-sectional view along the FF direction; Icon labels: 1-Inner catheter; 2-Middle catheter; 21-Opening; 3-Outer catheter; 41-Second connecting rod; 411-Front end of the second connecting rod; 412-Rear end of the second connecting rod; 42-First connecting rod; 5-Anterior conical tube; 6-Rear conical tube; 7-Balloon; 8-Electrode membrane; 81-Front side of the electrode membrane; 82-Rear side of the electrode membrane; 83-Outer end of the electrode membrane; 84-Inner end of the electrode membrane; 9-Media channel; 10-Rotating seat; X-Centerline of the middle catheter; Y-Centerline of the pivot. Detailed Implementation

[0016] The present invention will be further described below with reference to embodiments. In the description of the present invention, the digestive tract refers to the oral cavity, esophagus, stomach, duodenum, small intestine, large intestine, anus, etc., and the term "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator, such as... Figure 3 As shown in the figure, the upper direction is the relative "distal" or "anterior", and the lower direction is the relative "proximal" or "posterior". In the left and right directions, the direction closer to the central conduit is "inner", and the direction farther from the central conduit is "outer". The above definitions of directions are only for the convenience of describing the present invention and simplifying the description. They are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0017] In some embodiments, the device for ablation treatment of the digestive tract according to the present invention includes an elongated inner catheter 1, an elongated middle catheter 2, an elongated outer catheter 3, a connector, an anterior conical tube 5, a posterior conical tube 6, a balloon 7, an electrode membrane 8, and a media channel 9.

[0018] The inner catheter 1 is used to pass through components such as guide wires. The middle catheter 2 is sleeved outside the inner catheter 1, and the outer catheter 3 is sleeved outside the middle catheter 2. The middle catheter 2 can be rotatably arranged relative to the outer catheter 3 around the axis X of the middle catheter extending in the front-back direction.

[0019] The medium channel 9 extends along the length of the middle conduit 2 or the outer conduit 3. The distal end of the medium channel 9 communicates with the balloon 7, and the proximal end of the medium channel 9 is used to connect to a medium pressure source (not shown in the figure). The interlayer between the inner conduit 1 and the middle conduit 2 constitutes the medium channel 9 for conveying the medium, which can be a liquid or a gas. In some embodiments, the inner conduit 1 is fixedly inserted into the lumen of the middle conduit 2, that is, the middle conduit 2 is fixedly disposed relative to the inner conduit 1. In other embodiments, the middle conduit 2 can also be rotatably disposed relative to the inner conduit 1. The end of the medium channel 9 is sealed by a rotating O-ring (not shown in the figure) to prevent leakage of the medium. In some embodiments, the interlayer between the middle conduit 2 and the outer conduit 3 can also constitute the medium channel 9, and the end of the medium channel 9 is sealed by a rotating O-ring (not shown in the figure) to prevent leakage of the medium.

[0020] In some embodiments, an actuator (not shown in the figure) is connected to the proximal end of the middle conduit 2 and the outer conduit 3. The actuator is used to drive the middle conduit 2 to rotate in the forward or reverse direction relative to the outer conduit 3. The forward and reverse rotation directions are opposite. For example, the forward direction can be a counterclockwise direction around the axis X of the middle conduit, and the reverse direction can be a clockwise direction around the axis X of the middle conduit.

[0021] The balloon 7 has a contracted state where its radial diameter decreases after the medium flows out and an expanded state where its radial diameter increases after the medium is injected. The balloon 7 is sleeved and surrounds the distal end of the middle catheter 2, and the inner side of the balloon 7 is fixedly connected to the distal end of the middle catheter 2. In some embodiments, the balloon 7 is specifically a compliant balloon, which rotates relative to the outer catheter 3 about the axis X of the middle catheter extending in the front-rear direction. The middle catheter 2 has an opening for connecting the inner cavity of the balloon 7 and the medium channel 9, so that the medium eventually flows to the balloon 7 to control its contraction and expansion.

[0022] Both the anterior conical tube 5 and the posterior conical tube 6 are located at the distal end of the device used for ablation treatment of the digestive tract. The anterior conical tube 5 is a cone that gradually expands from front to back, while the posterior conical tube 6 is a cone that gradually expands from back to front. The balloon 7 is positioned between the anterior conical tube 5 and the posterior conical tube 6. The distal ends of the inner catheter 1 and the middle catheter 2 are both located within the anterior conical tube 5, which is fixed relative to the inner catheter 1. Within the posterior conical tube 6, the outer catheter 3, the middle catheter 2, and the inner catheter 1 are sequentially arranged from the outside to the inside, with the posterior conical tube 6 fixed relative to the outer catheter 3.

[0023] The electrode membrane 8 is provided with multiple electrodes for receiving electrical signals. The electrode membrane 8 is an elastic electrode membrane, which causes the electrode membrane to be spirally wound around the outside of the balloon 7. In the winding direction of the electrode membrane 8, the electrode membrane 8 has an inner end portion 84 and an outer end portion 83. The inner end portion 84 is connected to the outside of the balloon 7, and the outer end portion 83 is connected to the distal end of the external catheter 3 through a connector. The connector includes a first connecting rod 42 and a second connecting rod 41. The first connecting rod 42 is fixedly connected to the outer end of the electrode membrane 8. One end of the second connecting rod 41 is pivotally connected to the distal end of the outer conduit 3. The other end of the second connecting rod 41 is pivotally connected to the first connecting rod 42. In some specific embodiments, a relief groove is provided on the rear tapered tube 6 to expose the outer conduit 3. The rear end 412 of the second connecting rod is pivotally connected to the distal end of the outer conduit 3. The front end 411 of the second connecting rod is pivotally connected to the rear end of the first connecting rod 42. The axis Y of the pivot is perpendicular to the axis X of the middle conduit.

[0024] In some embodiments, the system for ablation treatment of the digestive tract according to the present invention includes an apparatus for ablation treatment of the digestive tract, a signal generator (not shown), a medium pressure source (not shown), and a rotating base 10.

[0025] The signal generator is configured to generate an electrical signal for treatment and is electrically connected to the electrodes of the electrode membrane 8. The pressure source is connected to the medium channel 9, which is used to inject or aspirate the medium into the balloon 7 through the medium channel 9. The rotating seat 10 is fixedly connected to the proximal end of the middle catheter 2. Rotating the rotating seat 10 controls the rotation of the middle catheter 2 relative to the outer catheter 3.

[0026] The working principle of the device for ablation therapy of the digestive tract according to the present invention is explained below: like Figure 1 , 3 As shown in Figure -7, at this time, the balloon 7 is in a radially expanded state, the electrode membrane 8 is stretched open by the balloon 7, and the second connecting rod 41 extends obliquely from the rear end 412 to the front end 411 of the second connecting rod from the inside out. The balloon 7 fits against the inner side of the entire innermost circle of the electrode membrane 8, and the front part of the balloon 7 protrudes forward beyond the front side edge 81 of the electrode membrane, and the rear part of the balloon 7 protrudes backward beyond the rear side edge 82 of the electrode membrane, as shown in Figure -7. Figure 2 , 8 As shown in -12, at this time, the balloon 7 is in a radially shrinking contraction state, the electrode membrane 8 is relatively contracted, and the second connecting rod 41 extends vertically from the rear end 412 of the second connecting rod to the front end 411 of the second connecting rod.

[0027] When it is necessary to expand the electrode membrane 8, rotate the rotating seat 10 in the forward direction so that the middle catheter 2 rotates in the forward direction relative to the outer catheter 3. The middle catheter 2 drives the balloon 7 to rotate in the forward direction as well. Then the number of turns of the electrode membrane 8 gradually decreases and the diameter increases. The medium is injected into the balloon 7 through the medium channel 9 to expand the balloon 7, so that the balloon 7 is in a radially expanded state and radially supports the electrode membrane 8.

[0028] When it is necessary to shrink the electrode membrane 8, the rotating seat 10 is rotated in the opposite direction, so that the middle catheter 2 rotates in the opposite direction relative to the outer catheter 3. The middle catheter 2 drives the balloon 7 to rotate in the opposite direction as well. Then the number of turns of the electrode membrane 8 gradually increases and the diameter decreases. The medium is drawn into the balloon 7 through the medium channel 9, causing the balloon to shrink. The balloon 7 is in a radially shrinking contraction state and the electrode membrane 8 tightens the balloon 7.

[0029] It is understood that the same or similar parts in the above embodiments can be referred to each other, and the contents not described in detail in some embodiments can be referred to the same or similar contents in other embodiments.

[0030] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be construed as limiting the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A device for ablation therapy of the digestive tract, characterized in that, include: Slender central duct; A slender outer conduit is sleeved outside the middle conduit, and the middle conduit is rotatably disposed relative to the outer conduit; A balloon having a contracted state where the radial direction decreases after the medium flows out and an expanded state where the radial direction increases after the medium is injected, the balloon being sleeved and surrounding the distal end of the central catheter, and the inner side of the balloon being fixedly connected to the distal end of the central catheter. The medium channel extends along the length of the middle or outer catheter, with the distal end of the medium channel communicating with the balloon and the proximal end of the medium channel used to connect to a medium pressure source. An electrode membrane is provided with multiple electrodes for receiving electrical signals. The electrode membrane is spirally wound around the outside of the balloon. The inner end of the electrode membrane is connected to the outside of the balloon, and the outer end of the electrode membrane is connected to the distal end of the external catheter through a connector. During the forward rotation of the middle catheter relative to the outer catheter, the middle catheter also drives the balloon to rotate in the forward direction. As a result, the number of turns of the electrode membrane gradually decreases and its diameter increases. The balloon is in a radially expanding state and radially outwards supports the electrode membrane. During the reverse rotation of the middle catheter relative to the outer catheter, the middle catheter also drives the balloon to rotate in the reverse direction. As a result, the number of turns of the electrode membrane gradually increases and its diameter decreases. The balloon is in a radially shrinking contraction state.

2. The device for ablation therapy of the digestive tract according to claim 1, characterized in that: The connector includes a first connecting rod and a second connecting rod. The first connecting rod is fixedly connected to the outer end of the electrode membrane. One end of the second connecting rod is pivotally connected to the distal end of the external conduit, and the other end of the second connecting rod is pivotally connected to the first connecting rod.

3. The device for ablation therapy of the digestive tract according to claim 2, characterized in that: The rear end of the second connecting rod is pivotally connected to the distal end of the outer conduit, and the front end of the second connecting rod is pivotally connected to the rear end of the first connecting rod. The axis of the pivot is perpendicular to the axis of the middle conduit.

4. The device for ablation therapy of the digestive tract according to claim 1, characterized in that: During the process of the middle catheter rotating in the opposite direction to the outer catheter, the balloon is in a radially shrinking contraction state and the electrode membrane clamps the balloon.

5. The device for ablation therapy of the digestive tract according to claim 1, characterized in that: A medium channel extending along the length of the middle conduit is provided between the middle conduit and the outer conduit.

6. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that: An inner catheter is also fixedly inserted into the lumen of the middle catheter, and the interlayer between the inner catheter and the middle catheter forms a medium channel.

7. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that: An actuator is connected to the proximal end of the middle catheter and the outer catheter, and the actuator is used to drive the middle catheter to rotate in the forward or reverse direction relative to the outer catheter.

8. The apparatus for ablation therapy of the digestive tract according to claim 1, characterized in that: When the balloon is in the inflated state, the balloon is attached to the inside of the innermost layer of the electrode membrane, and the front part of the balloon protrudes forward beyond the front side of the electrode membrane, while the rear part of the balloon protrudes backward beyond the rear side of the electrode membrane.

9. A system for ablation therapy of the digestive tract, characterized in that: It includes the apparatus for ablation treatment of the digestive tract as described in any one of claims 1 to 8, and further includes: A signal generator configured to generate an electrical signal for treatment and electrically connected to the electrodes of the electrode membrane.

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