Balloon cryoablation device and ablation system for the digestive tract

Abstract

The utility model relates to a kind of for gastrointestinal tract's frozen balloon ablation device and ablation system, the ablation device includes elongated carrier, balloon carried by the elongated carrier, and refrigerant pipe for input refrigerant, wherein, the balloon has the balloon cavity capable of swelling, the refrigerant pipe has refrigerant outlet, and the refrigerant outlet is communicated the balloon cavity.When the ablation device is used for the ablation treatment of gastrointestinal tract, after the balloon is sent into the treatment site of gastrointestinal tract by elongated carrier, the balloon is inflated, refrigerant is injected into refrigerant pipe, the refrigerant can be vaporized to form low temperature after entering balloon cavity, so that surrounding tissue is frozen, thereby reaching the purpose of ablation treatment. The ablation device can be used in combination with endoscope, and both can enter or exit from gastrointestinal tract in human body, which is more convenient to operate.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a cryoballoon ablation device for the digestive tract, and an ablation system having the ablation device. Background Technology

[0002] Type 2 diabetes is a chronic metabolic disease characterized primarily by abnormally high blood glucose levels. Its core mechanism is insufficient insulin secretion or impaired insulin action, preventing glucose from effectively entering cells for energy and causing it to accumulate in the blood. Patients are chronically in a state of hyperglycemia and lipid metabolism disorders, placing a heavy metabolic burden on multiple organs and severely impacting their quality of life and life expectancy.

[0003] Currently, treatments for type 2 diabetes include diet control, exercise intervention, medication, and metabolic surgery. However, many patients who follow diet and exercise therapies experience a rebound in blood sugar due to their inability to maintain the regimen long-term; long-term medication use increases the burden on the liver and kidneys; and metabolic surgery often requires general anesthesia and laparoscopic / open surgery, which may lead to anastomotic leakage, malnutrition (such as iron / calcium deficiency), dumping syndrome, etc., and has a long recovery time, permanent changes in anatomical structure (such as reduced stomach capacity), and the inability to return to the original physiological state after surgery, and the difficulty of secondary surgery.

[0004] Duodenal mucosal remodeling (DMR) involves inserting specialized instruments into the duodenum via an endoscope. External energy is used to ablate and destroy the duodenal mucosa, remodeling it and improving insulin resistance and nutrient metabolism. This is a novel endoscopic treatment for metabolic syndrome. As an emerging minimally invasive endoscopic procedure, DMR is gaining popularity due to its advantages such as minimal invasiveness, convenience, minimal trauma, rapid recovery, ease of operation, precision, and reduced complication rates. Current techniques in clinical trials include steam ablation (Aqua Medical, Inc.), pulsed electric field ablation (Endogenex, Inc.), and hydrothermal balloon ablation (Fractylhealth, Inc.). However, while steam ablation rapidly ablates large areas of tissue through heat transfer, it carries a high risk of perforation. Pulsed electric field ablation, as a new technology, is still under investigation. Hydrothermal balloon ablation, while allowing precise control of the treatment area, requires dissection of the intestinal mucosa, making it complex and requiring a long learning curve.

[0005] Therefore, it is necessary to provide a novel ablation device for ablation therapy of the digestive tract. Utility Model Content

[0006] The purpose of this invention is to provide a cryoballoon ablation device for the digestive tract, for use in ablation therapy of the digestive tract.

[0007] To achieve the above objectives, the technical solution adopted by this utility model is: a cryoballoon ablation device for the digestive tract, the ablation device comprising an elongated carrier, a balloon mounted on the elongated carrier, and a refrigerant tube for introducing refrigerant, wherein the balloon has an inflatable balloon cavity, the refrigerant tube has a refrigerant outlet, and the refrigerant outlet is connected to the balloon cavity.

[0008] In some embodiments, the depth direction of the refrigerant outlet extends along the radial direction of the elongated carrier, such that the refrigerant is ejected through the refrigerant outlet toward the circumferential cavity wall of the balloon.

[0009] In some embodiments, the elongated carrier has a connecting rod segment extending through the balloon cavity, and the refrigerant tube has an output tube segment located in the balloon cavity, the output tube segment being fixedly disposed on the connecting rod segment.

[0010] In some embodiments, the refrigerant outlets are multiple, and the multiple refrigerant outlets are spaced apart along the length direction of the connecting rod segment, and / or the multiple refrigerant outlets are spaced apart along the circumferential direction of the connecting rod segment.

[0011] In some embodiments, the output pipe segment includes a winding portion that is spirally wound around the outer periphery of the connecting rod segment along the length direction of the connecting rod segment, the refrigerant outlet is disposed on the winding portion, and the refrigerant outlet has a plurality of outlets evenly spaced along the length direction of the winding portion.

[0012] In some embodiments, the balloon has an inflated state with increased lateral dimensions. The inflated balloon includes a first balloon portion, a balloon body, and a second balloon portion connected along the length direction. The first balloon portion and the second balloon portion are respectively fixedly connected to the outer periphery of the elongated carrier. The balloon body is cylindrical, and the winding portion is located in the balloon body along the length extension direction of the elongated carrier.

[0013] In some embodiments, the balloon has an inflated state with increased lateral dimensions, and the inflated balloon has at least a cylindrical balloon body, with the refrigerant outlet located between the two ends of the balloon body along the length extension direction of the elongated carrier.

[0014] In some embodiments, the ablation device further includes a contrast agent fixed to the connecting rod segment. The contrast agent has two sets arranged at intervals, and the two sets of contrast agents are correspondingly disposed at both ends of the capsule body along the length extension direction of the elongated carrier to indicate the position of the capsule body.

[0015] In some embodiments, the ablation device further includes a temperature measuring component for measuring the surface temperature of the balloon, the temperature measuring component including a temperature sensing element having a temperature sensing head fixedly disposed on the outer surface of the balloon body.

[0016] In some embodiments, the temperature sensing element is a flexible, deformable filament, the temperature sensing element is fixedly adhered to the outer surface of the balloon, and the temperature sensing element has multiple filaments arranged circumferentially at intervals.

[0017] In some embodiments, the temperature sensing element is a thermocouple, and / or the diameter of the temperature sensing element is 0.25 to 0.5 mm.

[0018] In some embodiments, the ablation device further includes a recovery tube for recovering refrigerant from the balloon cavity, the recovery tube being carried by the elongated carrier and having its opening communicating with the balloon cavity.

[0019] In some embodiments, the ablation device further includes a pressure measuring component for measuring the pressure within the balloon cavity, the pressure measuring component being mounted on the elongated carrier, and the pressure measuring component having at least a pressure sensing element located within the balloon cavity.

[0020] In some embodiments, the elongated carrier includes an inner catheter and an outer catheter, the outer catheter being fixedly fitted onto the inner catheter and exposing the distal end of the inner catheter, the balloon being fitted onto the distal end of the inner catheter, one end of the balloon being circumferentially sealed to the inner catheter, and the other end of the balloon being circumferentially sealed to the distal end of the outer catheter.

[0021] In some embodiments, the external catheter is provided with:

[0022] A medium channel, the medium channel being connected to the balloon cavity to inject a gaseous or liquid medium into the balloon cavity, thereby causing the balloon cavity to inflate.

[0023] The refrigerant tube is inserted into the pipe cavity and extends out of the external conduit from the proximal end of the external conduit.

[0024] This invention also provides a cryoballoon ablation system for the digestive tract, the ablation system comprising the cryoballoon ablation device as described above, and an endoscope, wherein...

[0025] The elongated carrier is also provided with a hollow channel running through it along the axial direction. The endoscope is inserted through the hollow channel, and the distal end of the endoscope is exposed in front of the elongated carrier.

[0026] Alternatively, the endoscope can be fitted onto the ablation device, and the balloon can be exposed in front of the endoscope.

[0027] Due to the application of the above technical solution, this utility model has the following advantages: The cryoballoon ablation device for the digestive tract provided in this utility model embodiment contains a balloon carried by a slender carrier and a refrigerant tube for introducing refrigerant. When this ablation device is used for ablation treatment of the digestive tract, the balloon is inserted into the treatment area of ​​the digestive tract through the slender carrier, causing the balloon to inflate. By injecting refrigerant into the refrigerant tube, the refrigerant enters the balloon cavity and vaporizes to form a low temperature, freezing the surrounding tissue and thus achieving the purpose of ablation treatment. This ablation device can be used in combination with an endoscope, and both can enter or exit the human digestive tract together, making operation more convenient and allowing doctors to more clearly observe the internal condition of the human digestive tract during surgery. Attached Figure Description

[0028] To more clearly illustrate the technical solution of this utility model, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the ablation device according to an embodiment of the present invention, wherein the balloon is in an inflated state;

[0030] Figure 2 for Figure 1 A schematic diagram of the internal structure of the ablation device (with the balloon hidden);

[0031] Figure 3 for Figure 2 A schematic diagram of the three-dimensional structure from another perspective;

[0032] Figure 4 for Figure 2 The structural diagram with the temperature measuring components and outer sleeve removed is based on the above.

[0033] Figure 5 for Figure 4 A schematic diagram of the three-dimensional structure from another perspective;

[0034] Figure 6 for Figure 5A front view structural diagram;

[0035] Figure 7 For along Figure 6 Schematic diagram of the cross-sectional structure along the AA direction;

[0036] Figure 8 for Figure 1 A schematic diagram of the connection structure between the winding part and the connecting rod section in the ablation device;

[0037] Figure 9 for Figure 1 A schematic diagram of the structure when the ablation device is used in combination with an endoscope;

[0038] in:

[0039] 1. Slender carrier; 11. Outer conduit; 12. Inner conduit; 121. Connecting rod segment; 13. Tip conduit; 14. Outer tube; 1a. Medium channel; 101. First channel; 102. Second channel; 103. Third channel; 104. Fourth channel; 105. Hollow channel;

[0040] 2. Balloon; 21. First balloon section; 22. Second balloon section; 23. Balloon body;

[0041] 3. Refrigerant pipe; 31. Output pipe section; 31a. Refrigerant outlet; 311. Winding section; 312. Connecting section; 32. Input pipe section; 32a. Refrigerant inlet;

[0042] 4. Temperature measuring component; 41. Temperature sensing element; 41a. Temperature sensing head;

[0043] 5. Developed parts;

[0044] 6. Recycling pipe; 61. Pipe opening;

[0045] 7. Pressure measuring components; 71. Pressure sensing elements;

[0046] 8. Endoscope. Detailed Implementation

[0047] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art. It should be noted that the description of these embodiments is for the purpose of aiding understanding the present invention, but does not constitute a limitation thereof. Furthermore, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0048] In this article, "proximal" and "far" are defined based on the distance between the ablation device and the operator after the operator inserts the ablation device into the human body. Specifically, "far end" refers to the end that is far away from the operator, also known as "anterior end"; "proximal end" refers to the end that is close to the operator, also known as "posterior end".

[0049] See Figures 1 to 8 As shown in the figure, the present invention provides a cryoballoon ablation device for the digestive tract. The ablation device includes an elongated carrier 1, a balloon 2 mounted on the elongated carrier 1, and a refrigerant tube 3 for introducing refrigerant. The balloon 2 has an inflatable balloon cavity, and the refrigerant tube 3 has a refrigerant outlet 31a that communicates with the balloon cavity.

[0050] In this cryoballoon ablation device, the balloon 2 can be made of polymer materials such as polyurethane, Pebax, silicone, and PA through a blow molding process. The balloon 2 has an expanded state with increased lateral dimensions. Specifically, by filling the balloon 2 with a liquid or gas medium, it can be expanded to a designed diameter or shape. Because the balloon 2 is made of an elastic polymer material, it can fully conform to the tissue surface after expansion. It should be noted that "lateral" here refers to the direction perpendicular to the longitudinal direction. The longitudinal direction is where the elongated carrier 1 extends, and "lateral" refers to the direction perpendicular to the extension direction of the elongated carrier 1.

[0051] This cryoballoon ablation device primarily achieves cryoablation through the Joule-Thomson effect, also known as the throttling expansion effect. This effect refers to the temperature drop caused by the expansion and heat absorption of a high-pressure fluid as it passes through a narrow capillary tube to a low-pressure region. Specifically, when using this ablation device for ablation treatment of the digestive tract, a balloon 2 is inserted into the treatment area of ​​the digestive tract via a slender carrier 1. After the balloon 2 inflates, a refrigerant, preferably a liquid refrigerant such as liquid nitrous oxide or liquid nitrogen, is injected into the refrigerant tube 3. This liquid refrigerant enters the balloon cavity through the refrigerant outlet 31a, where it vaporizes to create a low temperature, freezing the surrounding tissue. When the tissue temperature drops below -30°C, cells crystallize, ultimately causing cell necrosis and irreversible damage. Subsequently, intestinal cell regeneration (ICR) is used to regenerate these cells, restore metabolic signals, and improve the body's ability to control blood sugar levels, thereby slowing disease progression and achieving the therapeutic goal.

[0052] Referring to the accompanying drawings, the elongated carrier 1 has a connecting rod segment 121 extending into the balloon cavity; the refrigerant tube 3 has an output tube segment 31 located in the balloon cavity, and an input tube segment 32 connected to the output tube segment 31. The input tube segment 32 is disposed on the elongated carrier 1 and has a refrigerant inlet 32a exposed near the end of the elongated carrier 1. Liquid refrigerant is injected into the refrigerant tube 3 through the refrigerant inlet 32a, so that it passes through the input tube segment 32, the output tube segment 31, and then enters the balloon cavity through the refrigerant outlet 31a. The diameter of the refrigerant tube 3 is much smaller than the lateral dimension of the balloon 2 in the inflated state. Therefore, when the liquid refrigerant enters the balloon cavity, it will rapidly vaporize and expand, thereby lowering the temperature of the entire balloon 2.

[0053] Referring to the accompanying drawings, in this embodiment, the output tube segment 31 is fixedly mounted on the connecting rod segment 121. This allows the output tube segment 31 to be fixed to the elongated carrier 1, and also ensures that the output tube segment 31 is located as close as possible to the center of the balloon cavity. Specifically, multiple refrigerant outlets 31a are preferably provided, and these multiple refrigerant outlets 31a are spaced apart along the length of the connecting rod segment 121, and / or spaced apart along the circumference of the connecting rod segment 121. This allows liquid refrigerant to enter the balloon cavity through multiple refrigerant outlets 31a and vaporize in the balloon cavity in a relatively uniform manner, thereby achieving a rapid and even temperature reduction on the outer periphery of the balloon 2. The depth direction of the refrigerant outlets 31a is preferably extended radially along the elongated carrier 1. This allows the refrigerant to be sprayed radially towards the peripheral wall of the balloon 2 along the elongated carrier 1 when it is ejected, thereby rapidly cooling the surface of the balloon 2 and cooling the digestive tract tissue in contact with the balloon 2.

[0054] In this embodiment, the output pipe section 31 includes a winding portion 311 and a connecting portion 312 connected along the length direction. The connecting portion 312 extends along the length direction of the connecting rod section 121, and one end of it is connected to the input pipe section 32. It extends out in the form of a straight pipe to the proximal end of the slender carrier 1 and connects to the external host. The winding portion 311 is spirally wound around the outer periphery of the connecting rod section 121 along the length direction of the connecting rod section 121. Along the length extension direction of the winding portion 311, there are multiple refrigerant outlets 31a that are evenly spaced. In this way, the refrigerant outlets 31a are evenly spaced along the length direction of the connecting rod section 121 and along the circumferential direction of the connecting rod section 121. When the liquid refrigerant enters the balloon cavity, it can cover the entire balloon cavity 360° to achieve uniform cooling of the balloon 2.

[0055] In specific configuration, to prevent displacement of the winding part 311 on the connecting rod segment 121, the winding part 311 is fixed to the connecting rod segment 121 with adhesive. The refrigerant pipe 3 can be made of one-piece molded copper, nickel-titanium alloy, or stainless steel, which reduces connection points and prevents refrigerant leakage. The diameter of the refrigerant pipe 3 is preferably controlled between 0.4 and 2.0 mm, and the diameter of the refrigerant outlet 31a is preferably controlled between 0.1 and 0.5 mm.

[0056] In this embodiment, the inflated balloon 2 has a cylindrical shape in the middle and conical shapes at both ends. Specifically, see [link to relevant documentation]. Figure 1 and Figure 9 As shown, the inflated balloon 2 includes a first balloon portion 21, a balloon body 23, and a second balloon portion 22 connected along its length. The first balloon portion 21 and the second balloon portion 22 are respectively fixedly connected to the outer periphery of the elongated carrier 1. The balloon body 23 is cylindrical. When the balloon 2 reaches the treatment location in the digestive tract, the outer periphery of the balloon body 23 contacts the tissues of the digestive tract to achieve treatment. The diameter of the balloon 2 in the inflated state is preferably 20-60 mm, and the length is preferably 20-100 mm, wherein the length of the first balloon portion 21 and the second balloon portion 22 is preferably 5-15 mm.

[0057] In this ablation device, along the length of the slender carrier 1, the winding part 311 is located in the capsule body 23, which makes all the refrigerant outlets 31a located between the two ends of the capsule body 23. At the same time, all the refrigerant outlets 31a are arranged radially outward along the connecting rod section 121 toward the inner wall of the capsule body 23, which lowers the temperature of the part of the balloon 2 that is in contact with the digestive tract tissue, thereby achieving a precise and efficient ablation treatment effect.

[0058] Referring to the accompanying drawings, the ablation device also includes a contrast agent 5, which is fixed to the connecting rod segment 121. The contrast agent 5 has two sets spaced apart, and along the length of the elongated carrier 1, the two sets of contrast agents 5 are correspondingly located at both ends of the capsule body 23 to display and mark the position of the capsule body 23. This allows for clear identification of the location of the balloon 2 under DSA radiation, enabling accurate positioning of the capsule body 23 to the treatment site. The contrast agent 5 is preferably cut from a high-density metal tube such as tantalum, platinum-iridium alloy, or gold, and fixed to the connecting rod segment 121 by mechanical forging. Here, the contrast agent 5 is an annular component, fixedly fitted onto the outer periphery of the connecting rod segment 121. The inner diameter of the contrast agent 5 varies with the connecting rod segment 121, typically being 0.1–0.5 mm larger than the outer diameter of the connecting rod segment 121, while the length is preferably controlled between 1 and 2 mm.

[0059] The ablation device also includes a temperature measuring component 4 for measuring the surface temperature of the balloon 2. This component 4 includes a temperature sensing element 41 with a temperature-sensing head 41a, which is fixedly disposed on the outer surface of the balloon body 23. This component 4 allows for real-time monitoring of the ablation temperature to prevent over-ablation and damage to deeper tissues. The temperature sensing element 41 is a flexible, deformable filament that adapts to the expansion and contraction of the balloon 2. It is fixed to the outer surface of the balloon 2 by adhesive bonding, and multiple elements are spaced circumferentially to measure the temperature at different locations around the balloon body 23. Here, the temperature sensing elements 41 are thermocouples, evenly distributed circumferentially on the outer periphery of the balloon 2. The diameter of each thermocouple is 0.25–0.5 mm, and the preferred number is 4–12. Each thermocouple is connected to an external host unit via wires to display and provide real-time feedback on the tissue temperature during ablation, preventing tissue damage caused by temperature runaway.

[0060] The ablation device also includes a pressure measuring component 7 for measuring the pressure inside the balloon cavity. This component 7 is mounted on a slender carrier 1 and has at least one pressure sensing element 71 located within the balloon cavity. The pressure sensing element 71 is connected to an external host unit via wires to display the pressure inside the balloon cavity in real time. This allows for convenient control of the volume of gas or liquid medium injected into the balloon cavity during the inflation of the balloon 2, and real-time monitoring of pressure changes inside the balloon cavity after the liquid refrigerant enters, thus preventing excessive pressure and potential accidental rupture of the balloon 2. Due to the size limitations of the balloon 2, the pressure sensor needs to be miniaturized. A commercially available miniature fiber optic sensor fabricated using MEMS technology can be selected, as it is small in size and offers high measurement accuracy.

[0061] Referring to the accompanying drawings, in this embodiment, the elongated carrier 1 includes an inner catheter 12 and an outer catheter 11. The outer catheter 11 is fixedly fitted onto the inner catheter 12 and exposes the distal end of the inner catheter 12. The balloon 2 is fixedly fitted onto the distal end of the inner catheter 12; that is, the exposed portion of the distal end of the inner catheter 12 constitutes the connecting rod segment 121. One end of the balloon 2 is circumferentially sealed to the inner catheter 12, and the other end of the balloon 2 is circumferentially sealed to the distal end of the outer catheter 11. Specifically, the outer periphery of the balloon 2 can be fixed by laser welding, hot melting, or adhesive bonding to form a closed balloon cavity.

[0062] A tip catheter 13, also known as a TIP tip, is fixedly mounted on the distal end of the inner catheter 12. This tip catheter 13 is securely fitted onto the inner catheter 12, clamping the circumferential edge of the balloon 2 connected to the inner catheter 12 between the inner catheter 12 and the tip catheter 13. The tip catheter 13 is made of a flexible material with relatively low hardness, such as silicone, polyurethane, or low-hardness Pebax series materials. The tip catheter 13 not only connects to one end of the balloon 2, ensuring a good seal on the outer periphery of the balloon 2, but also sits at the very front of the slender carrier 1. Its smooth structure and material flexibility help prevent damage to the digestive tract tissues during the ablation process.

[0063] The outer conduit 11 has a medium channel 1a that connects to the balloon cavity to inject gas or liquid medium into the balloon cavity, thereby causing the balloon cavity to inflate. The outer conduit 11 also has a pipe cavity, in which the refrigerant pipe 3 is inserted and extends out of the outer conduit 11 from the proximal end. That is, the inlet pipe section 32 is inserted in the pipe cavity, and the refrigerant inlet 32a extends out from the proximal end of the outer conduit 11 to facilitate the injection of refrigerant.

[0064] The ablation device also includes a recovery tube 6 for recovering refrigerant from the balloon cavity. The recovery tube 6 is mounted on an elongated carrier 1, and its port 61 communicates with the balloon cavity. See here. Figure 5 As shown, the external catheter 11 also has a tubing cavity for the insertion of the retrieval tube 6. The port 61 of the retrieval tube 6 is located at its distal end and extends into the balloon cavity. After the ablation treatment is completed, the medium in the balloon cavity can be aspirated by the external device, thereby reducing the lateral size of the balloon 2. This facilitates the removal of the entire ablation device from the human digestive tract and also facilitates the recovery of the used refrigerant and other media outside the body for disposal. The retrieval tube 6 can be made of PI tube or nickel-titanium tube, etc., and its diameter is preferably 0.5 to 2 mm.

[0065] The elongated carrier 1 also includes an outer tube 14, which is fitted over the outer tube 11 with a gap between them. The wires connecting the temperature sensing elements 41 in the temperature measuring component 4 are threaded through the gap between the outer tube 14 and the outer tube 11, thus establishing a signal connection with the temperature measuring device at the proximal end of the elongated carrier 1. In this embodiment, the outer tube 14 can also slide relative to the outer tube 11 axially. This allows the balloon 2 to be in an uninflated state (i.e., in a state with reduced lateral dimensions), so that the temperature sensing elements 41 and the balloon 2 can enter the lumen of the outer tube 14 together. This facilitates the ablation device's entry and exit from the human digestive tract, reducing patient discomfort and preventing damage to the digestive tract during entry and exit. The inner tube 12, outer tube 11, and outer tube 14 can be made of the same polymer material, such as nylon, Pebax, PI, PE, etc.

[0066] See Figure 1 As shown, in the ablation device of this embodiment, the proximal end of the outer tube 14 is provided with a first channel 101, a second channel 102, a third channel 103, and a fourth channel 104. The first channel 101 is connected to the medium channel 1a to inject gas or liquid medium into the balloon 2, so that the balloon cavity is filled and expanded. The second channel 102 is through which the recovery tube 6 passes to connect to an external device to draw out the medium in the balloon cavity, so that the size of the balloon 2 is reduced and the used refrigerant is recovered. The third channel 103 is connected to the lumen of the refrigerant tube 3 to inject refrigerant into the refrigerant tube 3. The fourth channel 104 is through which the wires of the pressure measuring component 7 and the temperature measuring component 4 pass to connect to the external host, so as to obtain the pressure value inside the balloon 2 and the temperature value on the surface of the balloon 2 in real time.

[0067] In this embodiment, as shown in the accompanying drawings, the elongated carrier 1 is also provided with an axially penetrating hollow channel 105, which allows a guide wire to pass through axially, thereby providing guidance during the insertion of the ablation device into the human digestive tract. Specifically, both the inner catheter 12 and the tip catheter 13 have axially penetrating hollow cavities, and the two are connected axially to form the aforementioned hollow channel 105.

[0068] See Figure 9The ablation system shown includes the cryoballoon ablation device as described above, and an endoscope 8. The endoscope 8 is axially inserted into the hollow channel 105, with its distal end exposed in front of the elongated carrier 1. In this way, the ablation device can be fitted onto the endoscope 8 and enter or exit the human digestive tract together with the endoscope 8, making the operation more convenient and allowing doctors to more clearly observe the internal condition of the human digestive tract during surgery. At the same time, for the ablation device, it is only necessary to set the hollow channel 105 to be suitable for the endoscope 8 to pass through axially, without affecting the overall structure and operation of the ablation device, making it easier to manufacture.

[0069] When the ablation device is fitted onto endoscope 8 for use, such as Figure 9 As shown, the inner diameter of the inner catheter 12 needs to be increased to accommodate the endoscope 8. The inner diameter of the inner catheter 12, i.e., the diameter of the hollow cavity 105, is preferably in the range of 4 mm to 15 mm, and the outer diameter of the inner catheter 12 is preferably in the range of 5 mm to 18 mm. This allows it to be compatible with most models of endoscopes 8 on the market and can be directly combined with existing endoscopes 8. The outer diameter of the balloon 2 is preferably in the range of 7 mm to 20 mm, and the outer diameter of the tip catheter 13 is the same as the outer diameter of the outer tube 14, with a preferred size range of 7.5 mm to 21 mm.

[0070] In other embodiments, the endoscope 8 can be fitted onto the ablation device, allowing both the endoscope 8 and the ablation device to enter the human digestive tract. When in the digestive tract, the balloon 2 of the ablation device protrudes in front of the endoscope 8. When the endoscope 8 is fitted onto the ablation device, the outer diameter of the tip catheter 13 and the outer diameter of the outer sheath 14 are preferably between 2.5 and 4 mm, the outer diameter of the outer catheter 11 is between 2 and 3.5 mm, and the inner diameter of the inner catheter 12 is between 0.9 and 1.5 mm.

[0071] 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.

[0072] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art. In the event of any contradiction or inconsistency between the definitions used herein and those contained in other published documents, the definitions used herein shall prevail.

[0073] As indicated in this specification and claims, the terms "comprising" and "including" only indicate the inclusion of explicitly identified steps and elements, and these steps and elements do not constitute an exclusive list, and the method or apparatus may also include other steps or elements.

[0074] It can be further understood that in this disclosure, "multiple" refers to two or more, and other quantifiers are similar. "And / or" describes the relationship between related objects, indicating that three relationships can exist; for example, A and / or B can represent: A alone, A and B simultaneously, and B alone. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. The singular forms "a," "the," and "the" are also intended to include the plural forms unless the context clearly indicates otherwise.

[0075] It is further understood that the terms "first," "second," etc., are used to describe various types of information, but this information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another, and do not indicate a specific order or degree of importance. In fact, the expressions "first," "second," etc., are completely interchangeable. For example, without departing from the scope of this disclosure, first information can also be referred to as second information, and similarly, second information can also be referred to as first information.

[0076] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made based on the essence of this utility model should be covered within the scope of protection of this utility model.

Claims

1. A cryoballoon ablation device for the digestive tract, characterized in that: The ablation device includes an elongated carrier, a balloon mounted on the elongated carrier, and a refrigerant tube for introducing refrigerant, wherein the balloon has an inflatable balloon cavity, and the refrigerant tube has a refrigerant outlet communicating with the balloon cavity.

2. The cryoballoon ablation device for the digestive tract according to claim 1, characterized in that: The depth direction of the refrigerant outlet extends radially along the elongated carrier, such that the refrigerant is ejected from the refrigerant outlet toward the circumferential cavity wall of the balloon.

3. The cryoballoon ablation device for the digestive tract according to claim 1, characterized in that: The elongated carrier has a connecting rod segment extending through the balloon cavity, and the refrigerant tube has an output tube segment located in the balloon cavity, the output tube segment being fixedly disposed on the connecting rod segment.

4. The cryoballoon ablation device for the digestive tract according to claim 3, characterized in that: The refrigerant outlets are multiple, and the multiple refrigerant outlets are spaced apart along the length direction of the connecting rod segment, and / or the multiple refrigerant outlets are spaced apart along the circumferential direction of the connecting rod segment.

5. The cryoballoon ablation device for the digestive tract according to claim 3, characterized in that: The output pipe section includes a winding portion, which is spirally wound around the outer periphery of the connecting rod section along the length direction of the connecting rod section. The refrigerant outlet is located on the winding portion, and the refrigerant outlet has a plurality of outlets evenly spaced along the length direction of the winding portion.

6. The cryoballoon ablation device for the digestive tract according to claim 5, characterized in that: The balloon has an inflated state with increased lateral dimensions. In the inflated state, the balloon includes a first balloon portion, a balloon body, and a second balloon portion connected along the length direction. The first balloon portion and the second balloon portion are respectively fixedly connected to the outer periphery of the elongated carrier. The balloon body is cylindrical, and the winding portion is located in the balloon body along the length extension direction of the elongated carrier.

7. The cryoballoon ablation device for the digestive tract according to claim 3, characterized in that: The balloon has an inflated state with increased lateral dimensions. In the inflated state, the balloon has at least a cylindrical balloon body. Along the length of the elongated carrier, the refrigerant outlet is located between the two ends of the balloon body.

8. The cryoballoon ablation device for the digestive tract according to claim 7, characterized in that: The ablation device further includes a imaging element, which is fixed on the connecting rod segment. The imaging element has two sets arranged at intervals. Along the length extension direction of the slender carrier, the two sets of imaging elements are correspondingly arranged at both ends of the capsule body to indicate the position of the capsule body.

9. The cryoballoon ablation device for the digestive tract according to claim 7, characterized in that: The ablation device further includes a temperature measuring component for measuring the surface temperature of the balloon. The temperature measuring component includes a temperature sensing element with a temperature sensing head, which is fixedly disposed on the outer surface of the balloon body.

10. The cryoballoon ablation device for the digestive tract according to claim 9, characterized in that: The temperature sensing element is a flexible and deformable filament, which is fixedly attached to the outer surface of the balloon, and the temperature sensing element has multiple filaments arranged at intervals along the circumference.

11. The cryoballoon ablation device for the digestive tract according to claim 10, characterized in that: The temperature sensing element is a thermocouple, and / or the diameter of the temperature sensing element is 0.25 to 0.5 mm.

12. The cryoballoon ablation device for the digestive tract according to claim 1, characterized in that: The ablation device further includes a recovery tube for recovering refrigerant from the balloon cavity, the recovery tube being carried by the elongated carrier and having its opening connected to the balloon cavity.

13. The cryoballoon ablation device for the digestive tract according to claim 1, characterized in that: The ablation device further includes a pressure measuring component for measuring the pressure inside the balloon cavity, the pressure measuring component being mounted on the elongated carrier, and the pressure measuring component having at least a pressure sensing element located in the balloon cavity.

14. The cryoballoon ablation device for the digestive tract according to claim 1, characterized in that: The elongated carrier includes an inner catheter and an outer catheter. The outer catheter is fixedly sleeved on the inner catheter and protrudes from the distal end of the inner catheter. The balloon is sleeved on the distal end of the inner catheter. One end of the balloon is circumferentially sealed to the inner catheter, and the other end of the balloon is circumferentially sealed to the distal end of the outer catheter.

15. The cryoballoon ablation device for the digestive tract according to claim 14, characterized in that: The external conduit has the following openings: A medium channel, the medium channel being connected to the balloon cavity to inject a gaseous or liquid medium into the balloon cavity, thereby causing the balloon cavity to inflate. The refrigerant tube is inserted into the pipe cavity and extends out of the external conduit from the proximal end of the external conduit.

16. A cryoballoon ablation system for the digestive tract, characterized in that: The ablation system includes the cryoballoon ablation device as described in any one of claims 1 to 15, and an endoscope, wherein, The elongated carrier is also provided with a hollow channel running through it along the axial direction. The endoscope is inserted through the hollow channel, and the distal end of the endoscope is exposed in front of the elongated carrier. Alternatively, the endoscope can be fitted onto the ablation device, and the balloon can be exposed in front of the endoscope.

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