Double-balloon catheter

Abstract

The present invention provides a double-balloon catheter, comprising an inner balloon, an outer balloon, an outer tube, an inner tube, a heating part and an electrical processing device, wherein the inner tube passes through the outer tube, the outer balloon is fixedly connected to the outer tube, and the inner cavity of the outer balloon is connected to the inner cavity of the outer tube, the inner balloon is fixedly connected to the inner tube, and the inner cavity of the inner balloon is connected to the inner cavity of the inner tube, the inner balloon is arranged in the outer balloon, the heating part is arranged in the inner balloon, and the electrical processing device is electrically connected to the heating part via a heating wire to provide power for heating the heating part.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a double-balloon catheter. Background Art

[0002] The balloon catheter can be understood to include a catheter and a balloon arranged in the catheter. Furthermore, the medium can enter the balloon through the catheter, thereby expanding the balloon, and the expanded balloon can be used for expansion and other purposes.

[0003] However, existing balloon catheters typically only provide dilation, a relatively limited function that makes them difficult to meet the diverse medical and diagnostic needs of these procedures. For example, minimally invasive endoscopic procedures such as duodenal mucosal resurfacing aim to remove the surface epithelium to allow for subsequent epithelial regeneration and reset to a more insulin-sensitive state. This procedure replicates aspects of bariatric surgery, offering an attractive alternative for the treatment of metabolic diseases where ablation, in addition to dilation, is required, a need that existing balloon catheters struggle to meet. Summary of the Invention

[0004] The present invention provides a double-balloon catheter to solve the problem that the catheter has a single function and is difficult to meet the needs of ablation.

[0005] The present invention provides a double-balloon catheter, comprising an inner balloon, an outer balloon, an outer tube, an inner tube, a heating part and an electrical processing device, wherein the inner tube passes through the outer tube, the outer balloon is fixedly connected to the outer tube, and the inner cavity of the outer balloon is connected to the inner cavity of the outer tube, the inner balloon is fixedly connected to the inner tube, and the inner cavity of the inner balloon is connected to the inner cavity of the inner tube, the inner balloon is arranged in the outer balloon, the heating part is arranged in the inner balloon, and the electrical processing device is electrically connected to the heating part via a heating wire to provide power for heating the heating part.

[0006] Optionally, the inner balloon ring is arranged on the outside of the inner tube, and the heating part includes a heating coil fixed on the outside of the inner tube, the heating coil is electrically connected to the heating wire, the heating wire passes through the gap between the outer tube and the inner tube, the heating wire extends from the end of the inner tube away from the inner balloon and is electrically connected to the electrical treatment device, and the outer balloon is arranged at one end of the outer tube.

[0007] Optionally, the double-balloon catheter further includes a temperature detection portion, which extends to the outer surface of the outer balloon. The temperature detection portion is also electrically connected to the electrical processing device to feed back the detected temperature information to the electrical processing device.

[0008] Optionally, the temperature detection part includes a thermocouple wire, one end of which is arranged on the outer surface of the straight section of the outer balloon, the thermocouple wire passes through the gap between the outer tube and the inner tube, and the other end of the thermocouple wire is electrically connected to the electrical processing device.

[0009] Optionally, the double-balloon catheter further includes a connector, the first end of the connector being directly or indirectly connected to the end of the outer tube away from the outer balloon, the second end of the connector being connected to the electrical treatment device, a main channel being provided in the connector, the main channel being located between the first end and the second end of the connector, and the inner tube passing through the main channel.

[0010] Optionally, the double-balloon catheter further includes a stress diffusion tube, which is connected to the connector and wraps around the end of the outer tube away from the outer balloon and the first end of the connector.

[0011] Optionally, the side wall of the connecting piece is provided with a first injection part for injecting heating water, the inner tube is provided with a liquid inlet, and a heating water injection channel is provided in the first injection part. The heating water injection channel is connected to the liquid inlet and is connected to the inner tube and the inner cavity of the inner balloon through the liquid inlet, so that the heating water injected through the heating water injection channel can enter the inner cavity of the inner balloon.

[0012] Optionally, the side wall of the connecting piece is provided with a second injection part for injecting cooling water, and a cooling water injection channel is provided in the second injection part. The cooling water injection channel is connected to the main channel and is connected to the inner cavity of the outer balloon through the main channel, so that the cooling water injected through the cooling water injection channel can enter the inner cavity of the outer balloon.

[0013] Optionally, a sealing portion is further provided in the connector, and the sealing portion is provided on the outside of the inner tube, and the channel opening in the main channel connected to the cooling water injection channel and the liquid inlet are separated by the sealing portion.

[0014] Optionally, the first injection part and the second injection part are respectively connected to a two-way Luer connector.

[0015] The double-balloon catheter provided by the present invention utilizes an inner balloon within the outer balloon and a heating element within the inner balloon to achieve external heating. Consequently, the inner balloon can be considered a heating balloon. During use, for minimally invasive endoscopic procedures such as duodenal mucosal resurfacing, the temperature of the medium (e.g., liquid) within the balloon can be heated to the temperature required for thermal ablation of the epidermis. Thermal ablation is then achieved by conducting heat externally from the inner balloon. Simultaneously, the outer balloon can also protect the inner balloon. In further solutions, the outer balloon and outer catheter can be combined to allow for the injection of cooling water, thereby meeting the need for rapid cooling. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 This is a schematic diagram of the structure of a double-balloon catheter in one embodiment of the present invention. Figure 1 ;

[0018] Figure 2 This is a schematic diagram of the structure of a double-balloon catheter in one embodiment of the present invention. Figure 2 .

[0019] Description of reference numerals:

[0020] 1-Inner balloon;

[0021] 2-external saccule;

[0022] 3- Heating unit;

[0023] 301-heating coil;

[0024] 302-heating coil;

[0025] 4-Inner tube;

[0026] 401-liquid inlet;

[0027] 402-liquid inlet;

[0028] 5- outer tube;

[0029] 501-tip;

[0030] 6- Heating wire;

[0031] 601-first heating wire;

[0032] 602-second heating wire;

[0033] 7-Electrical processing device;

[0034] 8-Connector;

[0035] 801-main channel;

[0036] 802-second injection part;

[0037] 803-first injection part;

[0038] 9-stress diffusion tube;

[0039] 10- temperature detection unit;

[0040] 11-sealed part;

[0041] 12-two-way Luer connector;

[0042] 13-Two-way Luer connector. DETAILED DESCRIPTION

[0043] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0044] In the description of the specification of the present invention, it should be understood that the orientations or positional relationships indicated by the terms "upper part", "lower part", "upper end", "lower end", "lower surface", "upper surface", etc. are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention 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 therefore cannot be understood as a limitation on the present invention.

[0045] In the description of the present invention, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Therefore, features specified as "first" or "second" may explicitly or implicitly include one or more of such features.

[0046] In the description of the present invention, "plurality" means multiple, such as two, three, four, etc., unless otherwise clearly defined.

[0047] In the description of the present invention, unless otherwise specified or limited, the term "connection" and other terms should be understood in a broad sense. For example, it can mean fixed connection, detachable connection, or integration; it can mean mechanical connection, electrical connection, or mutual communication; it can mean direct connection or indirect connection through an intermediate medium; it can mean internal communication between two elements or interaction between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0048] The following specific embodiments are used to describe the technical solution of the present invention in detail. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described in detail in some embodiments.

[0049] Please refer to Figure 1 The double-balloon catheter includes an inner balloon 1, an outer balloon 2, an outer tube 5, an inner tube 4, a heating part 3 and an electrical treatment device 7.

[0050] The inner tube 4 passes through the outer tube 5; furthermore, part or all of the inner tube 4 may be located inside the outer tube 5, and a corresponding gap may be formed between the inner tube 4 and the outer tube 5, and the medium (such as liquid or gas) in the outer tube 5 may flow through the gap.

[0051] The outer balloon 2 is fixedly connected to the outer tube 5, and the inner cavity of the outer balloon 2 is connected to the inner cavity of the outer tube 5. Thus, a corresponding medium (such as liquid or gas) can flow between the inner cavity of the outer balloon 2 and the inner cavity of the outer tube 5. To achieve this flow, the outer tube 5 can be provided with a corresponding communication port, through which the inner cavity of the outer balloon 2 is connected to the inner cavity of the outer tube 5. In one example, the outer balloon 2 can be provided at one end of the outer tube 5 (this end can be understood as the distal end of the outer tube 5).

[0052] The inner balloon 1 is fixedly connected to the inner tube 4, and the inner lumen of the inner balloon 1 communicates with the inner lumen of the inner tube 4. Furthermore, a corresponding medium (e.g., liquid or gas) can flow between the inner lumens of the inner balloon 1 and the inner lumens of the inner tube 4. To achieve this flow, the inner tube 4 can be provided with a corresponding communication port (e.g., liquid inlet 401), through which the inner lumen of the inner balloon 1 communicates with the inner lumen of the inner tube 4. In one example, the inner balloon 1 can be disposed around the outer side of the inner tube, specifically adjacent to the distal end of the inner tube 4 (i.e., adjacent to the tip 501 of the inner tube 4).

[0053] In addition, the outer balloon 2 and the inner balloon 1 are both sealed with the inner tube 4 at the distal end of the balloon. The outer balloon 2 is sealed with the outer tube 5 at the proximal end of the balloon, and the inner balloon 1 is sealed with the inner tube 4 at the proximal end of the balloon.

[0054] The inner balloon 1 is arranged in the outer balloon 2. Specifically, the diameter of the inner balloon 1 can be larger than that of the outer balloon 2, and the compliance of the outer balloon 2 is higher than that of the inner balloon 1. The length of the outer balloon 2 is longer than that of the inner balloon 1, and the length of the inner balloon 1 can be greater than 2 cm.

[0055] After the inner balloon 1 expands, its heat can be conducted to the outside through the outer balloon 2 .

[0056] The heating part 3 is arranged in the inner balloon 1, and the electrical processing device 7 is electrically connected to the heating part 3 through the heating wire 6 to provide power for the heating of the heating part. For example, when heating is required, the electrical processing device 7 can output an electrical signal to make the heating part 3 generate heat. Any component that can generate heat based on an electrical signal can be understood as the heating part 3 involved in the embodiment of the present invention.

[0057] In one implementation, please refer to Figure 2 The heating part 3 includes a heating coil fixed to the outside of the inner tube 4, the heating coil is electrically connected to the heating wire, the heating wire passes through the gap between the outer tube and the inner tube, the heating wire 6 extends from the end of the inner tube away from the inner balloon 1 and is electrically connected to the electrical processing device 7, and the outer balloon 2 is arranged at one end of the outer tube 5.

[0058] In a specific example, the heating coils include a heating coil 301 near the distal end of the inner balloon and a heating coil 302 near the proximal end of the inner balloon. The heating wires may include a first heating wire 601 and a second heating wire 602. The heating coils 301 and 302 may be connected in series between the first heating wire 601 and the second heating wire 602. Simultaneously, the ends of the first heating wire 601 and the second heating wire 602 not connected to the heating coils may be connected to the electrical processing device 7, thereby forming a corresponding electrical circuit. Furthermore, the heating coils may be fixedly wound around the outside of the inner tube 1 or fixed to the inner cavity of the inner balloon using other methods.

[0059] The inner balloon 1 and the outer balloon 2 may be any structure that can expand when filled with an internal medium. At the same time, the balloon walls of the inner balloon 1 and the outer balloon 2 may have a certain heat conduction capability.

[0060] The inner balloon within the outer balloon, along with the heating element within it, enables external heating. The inner balloon can then be considered a heating balloon. During use, for example, in minimally invasive endoscopic procedures like duodenal mucosal resurfacing, the medium (e.g., liquid) within the balloon can be heated to the required temperature for epidermal ablation. Thermal ablation is then achieved through the inner balloon's external heat conduction. Furthermore, the outer balloon can also protect the inner balloon.

[0061] In one implementation, please refer to Figure 2The double-balloon catheter also includes a temperature detection part 10, which extends to the outer surface of the outer balloon 2. The temperature detection part 10 is also electrically connected to the electrical processing device 7 to feed back the detected temperature information (such as information representing the temperature of the outer surface of the outer balloon 2) to the electrical processing device 7.

[0062] The electrical processing device 7 can control the heating of the heating part based on the detected temperature information, or it can feed it back to the control device to which it is connected, and then, under the control of the control device, control the heating of the heating part (for example, controlling whether to output an electrical signal to implement heating, and for example, at what intensity to heat, etc.).

[0063] Furthermore, the temperature detection part 10 includes a thermocouple wire, one end of which is arranged on the outer surface of the straight section of the outer balloon 2, the thermocouple wire passes through the gap between the outer tube 5 and the inner tube 4, and the other end of the thermocouple wire is electrically connected to the electrical processing device 7.

[0064] Specifically, one end of the thermocouple wire is fixed to the surface of the straight section of the outer balloon 2 , and the other end penetrates from the outer tube portion close to the balloon, passes through the interior of the connector in parallel with the inner tube 4 and is connected to the electrical processing device 7 .

[0065] In the above solution, the temperature detection and feedback can be realized through the temperature detection unit 10, thereby providing a reference basis for heating control and ensuring the controllability of the heating process.

[0066] In one implementation, please refer to Figure 2 The double-balloon catheter further includes a connector 8, a first end of the connector 8 being directly or indirectly connected to the end of the outer tube 5 away from the outer balloon 2 (i.e., the proximal end of the outer tube 5), and a second end of the connector 8 being connected to the electrical treatment device 7. A main channel 801 is provided in the connector 8, and the main channel 801 is located between the first end and the second end of the connector 8, and the inner tube 4 passes through the main channel 801.

[0067] In one implementation, please refer to Figure 2 The double-balloon catheter further includes a stress diffusion tube 9, which is connected to the connector 8 and wraps around the end of the outer tube 5 away from the outer balloon 2 (i.e., the proximal end of the outer tube 5) and the first end of the connector 8. The dimensions of the two ends of the stress diffusion tube 9 are adapted to fit the outer tube 5 and the connector 8, achieving a tight fit between the three and a stress buffering effect. Specifically, the inner wall of the stress diffusion tube 9 can be in contact with the outer wall of the outer tube 5 and the outer wall of the connector 8, respectively.

[0068] In one implementation, please refer to Figure 2The sidewall of the connector 8 is provided with a first injection portion 803 for injecting heated water. The inner tube 4 is provided with a liquid inlet 402. A heated water injection channel is provided within the first injection portion 803. The heated water injection channel is connected to the liquid inlet 402 and, through the liquid inlet 402, to the inner tube 4 and the inner cavity of the inner balloon 1, so that the heated water injected through the heated water injection channel can enter the inner cavity of the inner balloon 1. The first injection portion 803 may be perpendicular to the sidewall of the connector 8.

[0069] In one implementation, please refer to Figure 2 The side wall of the connector 8 is provided with a second injection portion 802 for injecting cooling water. A cooling water injection channel is provided in the second injection portion 802. The cooling water injection channel communicates with the main channel 801 and, through the main channel 801, with the inner cavity of the outer balloon 2, so that the cooling water injected through the cooling water injection channel can enter the inner cavity of the outer balloon 2. The second injection portion 802 may be inclined relative to the side wall of the connector 8.

[0070] In the above scheme, based on the outer balloon and the outer catheter, cooling water can also be injected to meet the demand for rapid cooling.

[0071] As can be seen, both the heating water and the cooling water need to pass through the main channel, and thus, their circulation spaces need to be separated. To achieve this purpose, in one embodiment, a sealing portion 11 is further provided in the connector 8. The sealing portion 11 is provided on the outside of the inner tube 4. The channel opening in the main channel 801 that connects to the cooling water injection channel and the liquid inlet 402 are separated by the sealing portion 11. The sealing portion 11 can be of any structure and material that can achieve liquid-tight separation. It can be integral with the connector or assembled together. Regardless of the form, as long as it can separate the liquid, it does not depart from the scope of the embodiments of the present invention.

[0072] In addition, the connecting piece 8 is also tightly connected to the electrical processing device 7, and thus, the liquid in the connecting piece 8 cannot enter the electrical processing device. The connecting piece 8 is tightly connected to the outer tube 5, and the end length of the outer tube ends inside the connecting piece and does not reach the sealed fixed section (i.e., the sealed portion 11).

[0073] In a specific example, the first injection part 803 and the second injection part 802 are respectively connected to a two-way Luer connector, wherein the first injection part 803 is connected to the two-way Luer connector 13, and the second injection part 802 is connected to the two-way Luer connector 12.

[0074] In addition, heating water and cooling water can be understood as water used for heating and water used for cooling. The temperature of heating water is usually higher than that of cooling water, but before heating, the temperature of heating water may not be higher than that of cooling water.

[0075] Based on the delivery and heating of heated water, hydrothermal ablation can be achieved, thus being applied to minimally invasive endoscopic surgery using hydrothermal ablation

[0076] When using a double-balloon catheter as specifically exemplified by the present invention, the double-balloon catheter is placed to achieve mucosal lift and ablation. In this specific example, the ablation cycle is initiated by circulating hot water to complete the ablation of the lifted tissue. The balloon is then deflated and the catheter is remotely advanced to proceed to the next section of treatment. The process of expansion, ablation, and repositioning is repeated until the desired length of duodenum is treated (approximately 10 cm). A reusable electromechanical control console provides heating for the submucosal lift and hydrothermal ablation steps and monitors the balloon surface temperature.

[0077] Throughout this specification, references to terms such as "one embodiment," "an example," "a specific implementation," or "an example" indicate that the specific features, structures, materials, or characteristics described in conjunction with that embodiment or example are included in at least one embodiment or example of the present invention. In this specification, schematic representations of these terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0078] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, 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 embodiments of the present invention.

Claims

1. A double-balloon catheter, characterized in that: The balloon comprises an inner balloon, an outer balloon, an outer tube, an inner tube, a heating portion, and an electrical processing device, wherein the inner tube passes through the outer tube, the outer balloon is fixedly connected to the outer tube, and the inner cavity of the outer balloon communicates with the inner cavity of the outer tube, the inner balloon is annularly arranged on the outside of the inner tube and fixedly connected to the inner tube, and the inner cavity of the inner balloon communicates with the inner cavity of the inner tube, the inner balloon is arranged in the outer balloon, the heating portion is arranged in the inner balloon and fixed on the inner tube, and the electrical processing device is electrically connected to the heating portion via a heating wire to provide power for heating the heating portion; The invention also includes a connecting member, wherein a first end of the connecting member is directly or indirectly connected to an end of the outer tube away from the outer balloon, a second end of the connecting member is connected to the electrical treatment device, a main channel is defined in the connecting member, the main channel is located between the first end and the second end of the connecting member, and the inner tube passes through the main channel; The side wall of the connecting member is provided with a first injection portion and a second injection portion; the first injection portion is connected to the inner cavity of the inner tube, and the second injection portion is connected to the inner cavity of the outer balloon; It also includes a temperature detection part, one end of which extends to the outer surface of the outer balloon, and the other end of which penetrates from the outer tube part close to the balloon, passes through the interior of the connector in parallel with the inner tube and is electrically connected to the electrical processing device to feed back the detected temperature information to the electrical processing device.

2. The double-balloon catheter according to claim 1, characterized in that: The heating part includes a heating coil fixed to the outside of the inner tube, the heating coil is electrically connected to the heating wire, the heating wire passes through the gap between the outer tube and the inner tube, the heating wire extends from the end of the inner tube away from the inner balloon and is electrically connected to the electrical treatment device, and the outer balloon is arranged at one end of the outer tube.

3. The double-balloon catheter according to claim 1, characterized in that: The temperature detection part includes a thermocouple wire, one end of which is arranged on the outer surface of the straight section of the outer balloon, the thermocouple wire passes through the gap between the outer tube and the inner tube, and the other end of the thermocouple wire is electrically connected to the electrical processing device.

4. The double-balloon catheter according to claim 1, characterized in that: It also includes a stress diffusion tube, which is connected to the connecting piece and wraps the end of the outer tube away from the outer balloon and the first end of the connecting piece.

5. The double-balloon catheter according to claim 1, characterized in that: The inner tube is provided with a liquid inlet, and the first injection part is provided with a heating water injection channel. The heating water injection channel is connected to the liquid inlet, and is connected to the inner tube and the inner cavity of the inner balloon through the liquid inlet, so that the heating water injected through the heating water injection channel can enter the inner cavity of the inner balloon.

6. The double-balloon catheter according to claim 5, characterized in that: A cooling water injection channel is provided in the second injection portion, and the cooling water injection channel is connected to the main channel and is connected to the inner cavity of the outer balloon through the main channel, so that the cooling water injected through the cooling water injection channel can enter the inner cavity of the outer balloon.

7. The double-balloon catheter according to claim 6, characterized in that: A sealing portion is further provided in the connector, and the sealing portion is provided on the outside of the inner tube. The channel opening in the main channel connected to the cooling water injection channel and the liquid inlet are separated by the sealing portion.

8. The double-balloon catheter according to claim 6, characterized in that: The first injection part and the second injection part are respectively connected to a two-way Luer connector.

Images