Balloon dilatation device and system

Abstract

The utility model relates to a balloon dilatation device and system. The balloon dilatation device comprises a puncture unit, a first injection unit, a guide wire unit, a dilatation unit, a balloon unit, a second injection unit and a third injection unit. The carpal transverse ligament puncture device has the advantages that the puncture unit is arranged to be of an arc-shaped structure, the carpal transverse ligament puncture device can easily enter a carpal transverse ligament in a puncture mode and guide the guide wire unit to be placed on an affected part, liquid is injected through the first injection unit to guarantee the accuracy of the position of the puncture unit, and tissue on a path from skin to a target spot is preliminarily expanded through the expansion unit; the balloon unit is introduced through the guide wire unit, the balloon unit is filled with liquid through the second injection unit so that the size of the balloon unit can be increased, the transverse wrist ligament and the median nerve can be effectively separated, meanwhile, the balloon unit is arranged to be of a groove structure, a cutting space is reserved for cutting the transverse wrist ligament, the cutting depth and range can be accurately controlled, and the cutting efficiency is improved. Compression is completely relieved, and the median nerves can be prevented from being accidentally injured.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and in particular to a balloon dilation device and system. Background Art

[0002] The median nerve is a major nerve in the arm that controls the motor function of some hand muscles and provides sensation. The transverse carpal ligament (TLC) is located in the wrist and connects the wrist bones to form the carpal tunnel. When the transverse carpal ligament becomes abnormally thick or tense, it can compress the median nerve and cause carpal tunnel syndrome (CTS).

[0003] Common methods for treating CTS include medication, physical therapy, wrist brace, ultrasound-guided needle knife cutting, open surgery, etc. Ultrasound-guided needle knife cutting of the transverse carpal ligament is a relatively direct method. It releases the compression on the median nerve by cutting the transverse carpal ligament. It has the advantages of less trauma, quick recovery, low cost, and high patient acceptance, so it should be more and more used clinically. However, since the median nerve is closely adjacent to the transverse carpal ligament, it is very easy to damage the median nerve during surgery, leading to postoperative complications such as numbness, pain, and even permanent sensory or motor dysfunction in the fingers. On the other hand, due to the limitations of the surgical field of view and operating space, it is difficult for doctors to accurately control the cutting depth and range, and sometimes the compression cannot be completely relieved or excessive cutting leads to structural instability.

[0004] In the above treatment methods, the key to the operation is to separate the transverse carpal ligament from the median nerve to ensure that the cutting is thorough and safe, and to avoid damaging the median nerve. Currently, the separation method is to inject liquid between the two. The separation time is very short, and the liquid disperses in a short time, which cannot meet the needs of surgical operation. On the other hand, when the median nerve is severely compressed, the space between the median nerve and the transverse carpal ligament is smaller, and the injected liquid is difficult to remain between the two, but gathers at both ends, which is difficult to meet the operation requirements of minimally invasive surgery.

[0005] In recent years, balloon dilatation technology has been widely used in the field of vascular and cardiac interventional treatment due to its advantages such as minimal invasiveness and strong controllability. However, there are no reports on balloon dilatation technology in the treatment of nerve compression diseases, especially in the separation of the median nerve and the transverse carpal ligament.

[0006] There is no effective solution yet for the problems existing in related technologies, such as the inability to effectively separate the transverse carpal ligament and the median nerve, the inability to completely relieve compression, and the inability to protect the median nerve due to excessive cutting. Utility Model Content

[0007] The purpose of the utility model is to provide a balloon dilation device and system to address the deficiencies in the prior art, so as to solve the problems existing in the related art, such as the inability to effectively separate the transverse carpal ligament from the median nerve, incomplete cutting of the transverse carpal ligament, and inability to protect the median nerve.

[0008] In order to achieve the above purpose, the technical solution adopted by the utility model is:

[0009] The first aspect of the utility model is to provide a balloon dilation device for isolating the transverse carpal ligament and the median nerve, comprising:

[0010] A puncture unit, the puncture unit is arranged in an arc shape and is used for puncture;

[0011] a first injection unit, which is detachably connected to the puncture unit and is used to inject a liquid medicine into an affected area through the puncture unit;

[0012] A guide wire unit, the guide wire unit removably passing through the puncture unit and the first injection unit, and used to enter the affected part through the puncture unit and the first injection unit to determine the position of the affected part;

[0013] An expansion unit, which is removably mounted on the guide wire unit and is used to enter the affected area along the guide wire unit to expand the tissue on the path from the patient's skin to the target point;

[0014] A balloon unit, wherein the balloon unit is removably sleeved on the guide wire unit, wherein a groove is provided at the distal end of the balloon unit and faces the transverse carpal ligament, and is used to enter the affected area along the guide wire unit to separate the transverse carpal ligament from the median nerve;

[0015] A second injection unit, which is detachably connected to the proximal section of the balloon unit and is used to inject liquid into the balloon unit to fill the distal section of the balloon unit and to aspirate the liquid in the balloon unit to shrink the distal section of the balloon unit;

[0016] A third injection unit is detachably connected to the second injection unit and is used for conveying liquid to the second injection unit and evacuating the balloon unit.

[0017] In some embodiments, the puncture unit comprises:

[0018] A puncture needle element, the puncture needle element is arranged in an arc shape, and the guide wire unit is removably arranged inside the puncture needle element for puncture;

[0019] A first connecting element is arranged at the proximal end section of the puncture needle element and is detachably connected to the first injection unit.

[0020] In some embodiments, the first injection unit comprises:

[0021] a first container element, which is detachably connected to the puncture unit and is used to store liquid medicine and inject the liquid medicine into the affected part of the patient through the puncture unit;

[0022] a first pushing element, the first pushing element being movably connected to the first container element and being used for pushing the medical solution in the first container element toward the puncture unit;

[0023] A channel element, the channel element is arranged through the first pushing element, and the interior of the channel element can removably pass through the guide wire unit;

[0024] A second connecting element is arranged at the distal end section of the first container element and is detachably connected to the puncture unit.

[0025] In some embodiments, the guide wire unit comprises:

[0026] A guide wire element, which is removably disposed inside the puncture unit and is used to enter the affected part through the puncture unit to determine the position of the affected part;

[0027] A first marking element is disposed at the distal end of the guidewire element and is used to assist imaging equipment in identifying the position of the distal end of the guidewire element.

[0028] In some of the embodiments, the expansion unit comprises:

[0029] An inner core element, the inner core element is removably arranged to cover the guide wire unit and is used to enter the affected area along the guide wire unit;

[0030] A gripping element, which is disposed at the proximal end of the inner core element and is used for gripping;

[0031] a third connecting element, the third connecting element being disposed at a proximal end section of the inner core element;

[0032] An outer sheath element, which is sleeved on the outside of the inner core element and is used to expand the tissue on the path from the patient's skin to the target point;

[0033] A fourth connecting element is arranged at the proximal end section of the outer sheath element and is detachably connected to the third connecting element.

[0034] In some of the embodiments, the balloon unit comprises:

[0035] A first catheter element, which is removably sleeved on the guide wire unit and is in communication with the second injection unit, and is used to enter the affected area along the guide wire unit and deliver liquid;

[0036] A balloon component, which is disposed at the distal end of the first catheter component and is in communication with the first catheter component, and is used to separate the transverse carpal ligament and the median nerve when the balloon is filled;

[0037] A groove element, the groove element is arranged on the balloon element, and is used to reserve a cutting space when cutting the transverse carpal ligament;

[0038] a second catheter element, which is disposed at a proximal end section of the first catheter element and is in communication with the second injection unit and is used for delivering liquid to the balloon element;

[0039] A fifth connecting element is disposed at an end of the proximal section of the second catheter element and connected to the second injection unit.

[0040] In some of the embodiments, the balloon unit further comprises:

[0041] A positioning element is arranged on the first conduit element and corresponds to the position of the groove element, and is used to locate the direction of the groove element.

[0042] In some of the embodiments, the balloon unit further comprises:

[0043] A second marking element is disposed at the distal end of the balloon element and is used to assist imaging equipment in identifying the position of the balloon element.

[0044] In some embodiments, the second injection unit comprises:

[0045] a third catheter element, the third catheter element being communicated with the balloon unit and the third injection unit respectively;

[0046] a sixth connecting element, which is disposed at the distal end section of the third catheter element and is detachably connected to the balloon unit;

[0047] a seventh connecting element, the seventh connecting element being arranged at a distal end section of the third catheter element and being detachably connected to the third injection unit;

[0048] a valve element, the valve element being arranged at a distal end section of the third catheter element and being used for controlling the communication states between the third catheter element and the balloon unit and the third injection unit respectively;

[0049] A pressure pump element is communicated with the proximal end section of the third catheter element and is used for obtaining the liquid delivered by the third injection unit and delivering the liquid to the balloon unit.

[0050] In some of the embodiments, the third injection unit comprises:

[0051] a second container element, which is detachably connected to the second injection unit and is used for storing liquid, delivering liquid to the second injection unit, and evacuating the balloon unit;

[0052] a second pushing element, which is movably connected to the second container element and is used to push the liquid in the second container element toward the second injection unit or to evacuate the balloon unit;

[0053] An eighth connecting element is disposed at a distal end section of the second container element and is detachably connected to the second injection unit.

[0054] In some of the embodiments, it also includes:

[0055] A fixing unit is worn on the patient's wrist and is detachably connected to the balloon unit to fix the balloon unit.

[0056] In some embodiments, the fixing unit includes:

[0057] a wearable element that is removably wearable on a patient's wrist;

[0058] An adjusting element, which is disposed at the end of the wearable element and is used to adjust and lock the size of the wearable element to adapt to different patients;

[0059] A fixing element is arranged at the end of the wearable element and is detachably connected to the wearable element and the balloon unit, respectively, and is used to fix the second end of the balloon unit to the patient's wrist.

[0060] The second aspect of the utility model is to provide a balloon dilation system, comprising:

[0061] The balloon dilatation device as described in the first aspect;

[0062] A real-time monitoring device is used to monitor and observe the position and status of the balloon dilatation device at the patient's affected area in real time.

[0063] The utility model adopts the above technical solution, and compared with the prior art, has the following technical effects:

[0064] The utility model discloses a balloon dilation device and system, which can more easily puncture into the transverse carpal ligament and guide the guide wire unit to the affected area by setting the puncture unit to an arc structure, inject liquid through the first injection unit to ensure the accuracy of the position of the puncture unit, and preliminarily dilate the tissue on the path from the skin to the target point through the expansion unit, and then use the guide wire unit to introduce the balloon unit, and fill the balloon unit with liquid through the second injection unit to increase the volume of the balloon unit, thereby effectively separating the transverse carpal ligament and the median nerve, and at the same time setting the balloon unit to a groove structure to reserve a cutting space when cutting the transverse carpal ligament. The cutting space can not only accurately control the cutting depth and range, completely relieve the compression, but also avoid accidental injury to the median nerve, solving the problems of ineffective separation of the transverse carpal ligament and the median nerve, inability to completely relieve the compression, and inability to protect the median nerve due to excessive cutting; and the fixing unit is used to further stabilize the balloon unit, effectively avoiding accidental touching of the balloon unit during the operation and affecting the operation. By setting up a real-time monitoring device, the status of the patient's affected area and the accuracy of the positions of the puncture unit, guide wire unit and balloon unit can be observed in real time, providing a guarantee for the smooth progress of the needle knife cutting and release operation on the transverse carpal ligament. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 is a schematic diagram of a balloon dilatation device according to an embodiment of the utility model (I);

[0066] Figure 2 is a schematic diagram of a puncture unit according to an embodiment of the utility model;

[0067] Figure 3 is a schematic diagram of a first injection unit according to an embodiment of the utility model;

[0068] Figure 4 is a schematic diagram of a guide wire unit according to an embodiment of the utility model;

[0069] Figure 5 is a schematic diagram of an expansion unit according to an embodiment of the utility model;

[0070] Figure 6 is a schematic diagram of a balloon unit according to an embodiment of the utility model (I);

[0071] Figure 7 is a schematic diagram of a second injection unit according to an embodiment of the utility model;

[0072] Figure 8is a schematic diagram of a third injection unit according to an embodiment of the utility model;

[0073] Fig. 9 is a schematic diagram of a balloon unit according to an embodiment of the utility model (II);

[0074] Fig.10 is a schematic diagram of a balloon dilatation device according to an embodiment of the utility model (II);

[0075] Fig.11 is a schematic diagram of a fixing unit according to an embodiment of the utility model;

[0076] Fig.12 It is a schematic diagram of a balloon dilation system according to an embodiment of the utility model.

[0077] The accompanying drawings are denoted as follows:

[0078] 100. Balloon dilatation device;

[0079] 110. puncture unit; 111. puncture needle element; 112. first connecting element;

[0080] 120, first injection unit; 121, first container element; 122, first pushing element; 123, channel element; 124, second connecting element;

[0081] 130. Guide wire unit; 131. Guide wire element; 132. First marking element;

[0082] 140, expansion unit; 141, inner core element; 142, grip element; 143, third connection element; 144, outer sheath element; 145, fourth connection element;

[0083] 150, balloon unit; 151, first catheter element; 152, balloon element; 153, groove element; 154, second catheter element; 155, fifth connecting element; 156, positioning element; 157, second marking element;

[0084] 160, second injection unit; 161, third conduit element; 162, sixth connecting element; 163, valve element; 164, seventh connecting element; 165, pressure pump element;

[0085] 170, third injection unit; 171, second container element; 172, second pushing element; 173, eighth connecting element;

[0086] 180, fixing unit; 181, wearing element; 182, adjusting element; 183, fixing element;

[0087] 200. Real-time monitoring device. DETAILED DESCRIPTION

[0088] In order to make the purpose, technical solutions and advantages of the present application clearer, the present application is described and illustrated below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not intended to limit the present application. Based on the embodiments provided in the present application, all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the present application.

[0089] Obviously, the drawings described below are only some examples or embodiments of the present application. For ordinary technicians in this field, the present application can also be applied to other similar scenarios based on these drawings without creative work. In addition, it can also be understood that although the efforts made in this development process may be complicated and lengthy, for ordinary technicians in this field related to the content disclosed in this application, some changes in design, manufacturing or production based on the technical content disclosed in this application are just conventional technical means, and should not be understood as insufficient content disclosed in this application.

[0090] Reference to "embodiments" in this application means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those of ordinary skill in the art that the embodiments described in this application may be combined with other embodiments without conflict.

[0091] Unless otherwise defined, the technical terms or scientific terms involved in this application should be understood by people with ordinary skills in the technical field to which this application belongs. The words "one", "a", "a", "the" and the like involved in this application do not indicate a quantitative limitation, and may represent the singular or plural. The terms "include", "comprise", "have" and any of their variations involved in this application are intended to cover non-exclusive inclusions; for example, a process, method, system, product or device that includes a series of steps or units (units) is not limited to the listed steps or units, but may also include steps or units that are not listed, or may also include other steps or units inherent to these processes, methods, products or devices. The words "connect", "connected", "coupled" and the like involved in this application are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. The "multiple" involved in this application refers to two or more. "And / or" describes the association relationship of associated objects, indicating that there can be three relationships, for example, "A and / or B" can mean: A exists alone, A and B exist at the same time, and B exists alone. The character " / " generally indicates that the objects before and after are in an "or" relationship. The terms "first", "second", "third", etc. involved in this application are only used to distinguish similar objects and do not represent a specific ordering of the objects.

[0092] Example 1

[0093] This embodiment relates to a balloon dilatation device.

[0094] An illustrative embodiment of the present utility model is as follows: Figure 1As shown, a balloon dilatation device 100 is used to isolate the transverse carpal ligament and the median nerve, and includes a puncture unit 110, a first injection unit 120, a guide wire unit 130, an expansion unit 140, a balloon unit 150, a second injection unit 160 and a third injection unit 170. The puncture unit 110 is arranged in an arc shape for puncture; the first injection unit is detachably connected to the puncture unit 110, and is used to inject liquid medicine into the affected part through the puncture unit 110; the guide wire unit 130 can be removably passed through the puncture unit 110 and the first injection unit 120, and is used to enter the affected part through the puncture unit 110 and the first injection unit 120 to determine the position of the affected part; the expansion unit 140 can be removably sleeved on the guide wire unit 130, and is used to enter the affected part along the guide wire unit 130 to dilate the tissue on the path from the patient's skin to the target point; the balloon unit 150 can be removably sleeved on the guide wire unit 110 30 is provided, the distal section of the balloon unit 150 is provided with a groove and faces the transverse carpal ligament, and is used to enter the affected area along the guide wire unit 130 to separate the transverse carpal ligament from the median nerve; the second injection unit 160 is detachably connected to the proximal section of the balloon unit 150, and is used to inject liquid into the balloon unit 150 to fill the distal section of the balloon unit 150 and to suck the liquid of the balloon unit 150 to shrink the distal section of the balloon unit 150; the third injection unit 170 is detachably connected to the second injection unit 160, and is used to transport liquid to the second injection unit 160 and to vacuum the balloon unit 150.

[0095] like Figure 2 As shown, the puncture unit 110 includes a puncture needle element 111 and a first connecting element 112. The puncture needle element 111 is arranged in an arc shape, and a guide wire unit 130 is removably arranged inside the puncture needle element 111 for puncture; the first connecting element 112 is arranged at the proximal end section of the puncture needle element 111 and is detachably connected to the first injection unit 120.

[0096] In some embodiments, the puncture needle element 111 is an arc-shaped puncture needle.

[0097] In some embodiments, the puncture needle element 111 includes a straight puncture needle and an arcuate puncture needle, wherein the proximal end section of the straight puncture needle is connected to the distal end section of the arcuate puncture needle; and the proximal end section of the arcuate puncture needle is provided with a first connecting element 112.

[0098] The first connection element 112 is connected to the puncture needle element 111 in a fixed connection, wherein the fixed connection includes but is not limited to a hot pressing fixed connection.

[0099] In some embodiments, the material of the first connecting element 112 includes but is not limited to plastic.

[0100] In some embodiments, the first connecting element 112 is a first connecting head.

[0101] like Figure 3 As shown, the first injection unit 120 includes a first container element 121, a first pushing element 122, a channel element 123 and a second connecting element 124. The first container element 121 is detachably connected to the puncture unit 110, and is used to inject the liquid medicine into the affected part of the patient through the puncture unit 110; the first pushing element 122 is movably connected to the first container element 121, and is used to push the liquid medicine in the first container element 121 to move toward the puncture unit 110; the channel element 123 is arranged through the first pushing element 122, and the inside of the channel element 123 can removably pass through the guide wire unit 130; the second connecting element 124 is arranged at the distal end of the first container element 121, and is detachably connected to the puncture unit 110.

[0102] Specifically, the second connecting element 124 is detachably connected to the first connecting element 112 .

[0103] In some of the embodiments, the first container component 121 is a first syringe.

[0104] The size of the first pushing element 122 matches the size of the first container element 121. Generally, the radial size (such as the outer diameter) of the first pushing element 122 is not greater than the radial size (such as the inner diameter) of the first container element 121, and the length of the first pushing element 122 is greater than the length of the first container element 121.

[0105] In some embodiments, the first pushing element 122 includes a first injection piston and a first injection push rod. The first injection piston is movably disposed on the first container element 121; the first injection push rod is connected to the first injection piston, and is used for a user to hold the first injection push rod and push the first injection piston to slide in the first container element 121 to deliver the liquid medicine in the first container element 121 to the puncture unit 110.

[0106] The channel element 123 is disposed through the first injection piston and the first injection push rod.

[0107] The size of the channel element 123 matches the size of the first pushing element 122. Generally, the radial size (such as the outer diameter) of the channel element 123 is smaller than the radial size (such as the outer diameter) of the first injection push rod and the radial size (such as the outer diameter) of the first piston of the first pushing element 122, and the length of the channel element 123 is equal to the length of the first pushing element 122.

[0108] In some of the embodiments, the channel element 123 is a first channel.

[0109] The detachable connection between the second connecting element 124 and the first connecting element 112 includes, but is not limited to, snap-fitting and plug-fitting.

[0110] The size of the second connection element 124 matches the size of the first connection element 112. Generally, the radial size (eg, outer diameter) of the second connection element 124 is equal to the radial size (eg, inner diameter) of the first connection element 112.

[0111] The size of the second connection element 124 matches the size of the first container element 121. Generally, the radial size (eg, outer diameter) of the second connection element 124 is smaller than the radial size (eg, outer diameter) of the first container element 121.

[0112] In some embodiments, the second connecting element 124 is a second connecting head.

[0113] like Figure 4 As shown, the guide wire unit 130 includes a guide wire element 131 and a first marking element 132. The guide wire element 131 is removably disposed inside the puncture unit 110, and is used to enter the affected part through the puncture unit 110 to determine the position of the affected part; the first marking element 132 is disposed at the distal end of the guide wire element 131, and is used to assist the imaging device in identifying the position of the distal end of the guide wire element 131.

[0114] Specifically, the guide wire element 131 is removably disposed on the puncture needle element 111 and the first container element 121 .

[0115] More specifically, the guide wire element 131 passes through the channel element 123 and the puncture needle element 111 and is then placed into the affected area.

[0116] The size of the guide wire element 131 matches the size of the puncture needle element 111. Generally, the radial size (such as the outer diameter) of the guide wire element 131 is smaller than the radial size (such as the inner diameter) of the puncture needle element 111.

[0117] The size of the guide wire element 131 matches the size of the channel element 123. Generally, the radial size (such as the outer diameter) of the guide wire element 131 is smaller than the radial size (such as the inner diameter) of the channel element 123.

[0118] The size of the guide wire element 131 matches the size of the second connecting element 124. Generally, the radial size (such as the outer diameter) of the guide wire element 131 is smaller than the radial size (such as the inner diameter) of the second connecting element 124.

[0119] In some embodiments, the guidewire element 131 is a medical guidewire.

[0120] The first marking element 132 is connected to the guide wire element 131 in a fixed connection, wherein the fixed connection includes but is not limited to integral molding.

[0121] In some of the embodiments, the first marking element 132 is arranged to cover the top end of the guide wire element 131 , and can also be used by medical personnel to identify the insertion end of the guide wire element 131 .

[0122] In some embodiments, the first marking element 132 is made of a medical fluorescent material.

[0123] In some embodiments, the first marking element 132 is a fluorescent marker.

[0124] like Figure 5 As shown, the expansion unit 140 includes an inner core element 141, a gripping element 142, a third connecting element 143, an outer sheath element 144 and a fourth connecting element 145. The inner core element 141 is removably sleeved with the guide wire unit 130, and is used to enter the affected part along the guide wire unit 130; the gripping element 142 is disposed at the proximal end section of the inner core element 141, and is used for gripping; the third connecting element 143 is disposed at the proximal end section of the inner core element 141; the outer sheath element 144 is sleeved on the outside of the inner core element 141, and is used to expand the tissue on the path from the patient's skin to the target point; the fourth connecting element 145 is disposed at the proximal end section of the outer sheath element 144, and is detachably connected to the third connecting element 143.

[0125] Specifically, the inner core element 141 is arranged to sleeve the guide wire element 131 and is used to enter the affected area along the guide wire element 131 .

[0126] The inner core element 141 is a hollow structure.

[0127] The size of the inner core element 141 matches the size of the guide wire element 131. Generally, the radial size (such as the inner diameter) of the inner core element 141 is greater than the radial size (such as the outer diameter) of the guide wire element 131.

[0128] In some of the embodiments, the inner core element 141 is a dilator inner core.

[0129] The holding element 142 and the inner core element 141 are connected in a fixed manner, wherein the fixed connection manner includes but is not limited to hot pressing connection.

[0130] The size of the gripping element 142 matches the size of the inner core element 141. Generally, the radial size (such as outer diameter, length, width) of the gripping element 142 is greater than the radial size (such as outer diameter, length, width) of the inner core element 141.

[0131] In some embodiments, the material of the gripping element 142 includes but is not limited to plastic.

[0132] In some of the embodiments, the gripping element 142 is a handle.

[0133] The third connection element 143 is disposed on the outer edge surface of the inner core element 141 .

[0134] The third connecting element 143 is connected to the inner core element 141 in a fixed connection, wherein the fixed connection includes but is not limited to integral molding.

[0135] In some embodiments, the third connecting element 143 is a third connecting head.

[0136] The size of the outer sheath element 144 matches the size of the inner core element 141. Generally, the radial size (such as inner diameter) of the outer sheath element 144 is larger than the radial size (such as outer diameter) of the inner core element 141, and the length of the outer sheath element 144 is smaller than the length of the inner core element 141.

[0137] In some of these embodiments, the sheath element 144 is a dilator sheath.

[0138] The fourth connecting element 145 is connected to the outer sheath element 144 in a fixed connection, wherein the fixed connection includes but is not limited to integral molding.

[0139] The detachable connection method between the fourth connecting element 145 and the third connecting element 143 includes but is not limited to snap connection.

[0140] The size of the fourth connecting element 145 matches the size of the outer sheath element 144. Generally, the radial size (eg, outer diameter) of the fourth connecting element 145 is greater than the radial size (eg, outer diameter) of the outer sheath element 144.

[0141] The size of the fourth connecting element 145 matches the size of the third connecting element 143. Generally, the radial size (such as the inner diameter) of the fourth connecting element 145 is not less than the radial size (such as the outer diameter) of the third connecting element 143.

[0142] In some embodiments, the fourth connecting element 145 is a fourth connecting head.

[0143] like Figure 6As shown, the balloon unit 150 includes a first catheter element 151, a balloon element 152, a groove element 153, a second catheter element 154 and a fifth connecting element 155. The first catheter element 151 is removably sleeved with the guide wire unit 130 and communicated with the second injection unit 160, and is used to enter the affected area along the guide wire unit 130 and transport liquid; the balloon element 152 is arranged at the distal end section of the first catheter element 151 and is communicated with the first catheter element 151, and is used to separate the transverse carpal ligament from the median nerve under the condition of filling; the groove element 153 is arranged at the balloon element 152, and is used to reserve cutting space when cutting the transverse carpal ligament; the second catheter element 154 is arranged at the proximal end section of the first catheter element 151, and is communicated with the second injection unit 160, and is used to transport liquid to the balloon element 152; the fifth connecting element 155 is arranged at the end of the proximal end section of the second catheter element 154, and is connected with the second injection unit 160.

[0144] Specifically, the first catheter element 151 is removably sheathed around the guidewire element 131 .

[0145] The first conduit element 151 is a hollow structure.

[0146] The size of the first catheter element 151 matches the size of the guidewire element 131. Generally, the radial size (such as the inner diameter) of the first catheter element 151 is larger than the radial size (such as the outer diameter) of the guidewire element 131, and the length of the first catheter element 151 is smaller than the length of the guidewire element 131.

[0147] In some embodiments, the radial dimension of the first catheter element 151 is 6 to 12 cm, preferably 8 to 10 cm.

[0148] In some embodiments, the first catheter element 151 includes a first catheter, a second channel and a third channel. The second channel is set to penetrate the first catheter for the guidewire element 131 to pass through; the third channel is set inside the first catheter and located on one side of the second channel, and is respectively connected to the balloon element 152 and the second catheter element 154, and is used to transport liquid to the balloon element 152.

[0149] The balloon component 152 and the first catheter component 151 are connected in a fixed manner, wherein the fixed connection manner includes but is not limited to integral molding and adhesive connection.

[0150] The size of the balloon member 152 matches the size of the first catheter member 151. Generally, the radial size (eg, outer diameter) of the balloon member 152 in the inflated state is greater than the radial size (eg, outer diameter) of the first catheter member 151.

[0151] In some embodiments, the outer diameter of the balloon member 152 in the inflated state is 20 mm to 30 mm, preferably 25 mm.

[0152] In some embodiments, the inner diameter of the balloon member 152 in the filled state is 6 mm to 12 mm, preferably 8 mm to 10 mm.

[0153] In some embodiments, the length of the balloon member 152 is 20 mm to 35 mm, preferably 29 mm to 31 mm.

[0154] In some of the embodiments, the balloon element 152 includes a balloon and a fourth channel, wherein the balloon is connected to the third channel of the first catheter element 151 for dilating the affected area; the fourth channel runs through the balloon setting and is connected to the second channel of the first catheter element 151 for the guidewire element 131 to pass through.

[0155] The size of the groove member 153 matches the size of the balloon member 152. Generally, the length of the groove is equal to the length of the balloon member 152, and the radius of the groove is smaller than the radius of the balloon member 152.

[0156] In some of the embodiments, the arc angle of the groove element 153 is 30-90°.

[0157] The second conduit element 154 is connected to the first conduit element 151 in a fixed connection, wherein the fixed connection method includes but is not limited to integral molding and hot pressing.

[0158] The size of the second conduit element 154 matches the size of the first conduit element 151. Generally, the radial size (eg, outer diameter) of the second conduit element 154 is not less than the radial size (eg, outer diameter) of the first conduit element 151.

[0159] In some embodiments, the second catheter element 154 includes a second catheter and a fifth channel. The second catheter is connected to the first catheter of the first catheter element 151, and the proximal end of the second catheter is provided with a fifth connecting element 155; the fifth channel is connected to the third channel of the first catheter element 151.

[0160] The fifth connecting element 155 and the second conduit element 154 are connected in a fixed manner, wherein the fixed connection manner includes but is not limited to integral molding and hot pressing.

[0161] The size of the fifth connecting element 155 matches the size of the second conduit element 154. Generally, the radial size (eg, outer diameter) of the fifth connecting element 155 is greater than the radial size (eg, outer diameter) of the second conduit of the second conduit element 154.

[0162] In some embodiments, the fifth connecting element 155 is a fifth connecting head.

[0163] like Figure 7 As shown, the second injection unit 160 includes a third catheter element 161, a sixth connecting element 162, a valve element 163, a seventh connecting element 164 and a pressure pump element 165. The third catheter element 161 is connected to the balloon unit 150 and the third injection unit 170 respectively; the sixth connecting element 162 is arranged at the distal end section of the third catheter element 161 and is detachably connected to the balloon unit 150; the valve element 163 is arranged at the distal end section of the third catheter element 161, and is used to control the connection state of the third catheter element 161 with the balloon unit 150 and the third injection unit 170 respectively; the seventh connecting element 164 is arranged at the distal end section of the third catheter element 161, and is detachably connected to the third injection unit 170; the pressure pump element 165 is connected to the proximal end section of the third catheter element 161, and is used to obtain the liquid delivered by the third injection unit 170 and deliver the liquid to the balloon unit 150.

[0164] Specifically, the third conduit element 161 is in communication with the second conduit element 154 ; and the sixth connection element 162 is connected with the fifth connection element 155 .

[0165] In some embodiments, the third conduit element 161 includes a third conduit, a sixth channel, a fourth conduit and a seventh channel. The distal end of the third conduit is provided with a sixth connecting element 162, the proximal end of the third conduit is connected to a pressure pump element 165 and is connected to the second conduit of the second conduit element 154; the sixth channel is provided in the third conduit and is connected to the fifth channel; the fourth conduit is provided in the distal end of the third conduit, the proximal end of the fourth conduit is provided with a seventh connecting element 164 and is connected to the third conduit, and the connecting position of the fourth conduit and the third conduit is provided with a valve element 163; the seventh channel is provided in the fourth conduit and is connected to the fifth channel and the sixth channel.

[0166] The sixth connection element 162 and the third conduit element 161 are connected in a fixed manner, wherein the fixed connection manner includes but is not limited to integral molding.

[0167] The sixth connection element 162 and the fifth connection element 155 are connected in a detachable manner, wherein the detachable connection manner includes but is not limited to a snap connection and a plug connection.

[0168] The size of the sixth connecting element 162 matches the size of the third conduit element 161. Generally, the radial size (eg, outer diameter) of the sixth connecting element 162 is greater than the radial size (eg, outer diameter) of the third conduit element 161.

[0169] The size of the sixth connecting element 162 matches the size of the fifth connecting element 155. Generally, the radial size (eg, inner diameter) of the sixth connecting element 162 is equal to the radial size (eg, inner diameter) of the third passage of the fifth connecting element 155.

[0170] In some embodiments, the sixth connecting element 162 is a sixth connecting head.

[0171] The valve element 163 and the third conduit element 161 are connected in a fixed manner, wherein the fixed connection manner includes but is not limited to integral molding.

[0172] The valve element 163 matches the size of the third conduit element 161. Generally, the radial size (eg, outer diameter) of the valve element 163 is equal to the radial size (eg, inner diameter) of the third conduit element 161.

[0173] In some of the embodiments, the valve element 163 is a three-way valve.

[0174] The seventh connection element 164 is connected to the third conduit element 161 in a fixed connection, wherein the fixed connection includes but is not limited to integral molding.

[0175] The size of the seventh connecting element 164 matches the size of the third conduit element 161. Generally, the radial size (eg, outer diameter) of the seventh connecting element 164 is greater than the radial size (eg, outer diameter) of the third conduit element 161.

[0176] In some of the embodiments, the seventh connecting element 164 is a seventh connecting head.

[0177] The pressure pump element 165 and the third conduit element 161 are connected in a detachable manner, wherein the detachable connection manner includes but is not limited to a snap connection and a plug connection.

[0178] In some embodiments, the pressure pump element 165 includes a second syringe, a second injection piston, a second injection push rod and a pressure pump. The second syringe is used to store liquid; the second injection piston is slidably disposed in the second syringe, and is used to suck or push liquid into the second syringe; the second injection push rod is connected to the second injection piston, and is used to hold and push the second injection piston to slide in the second syringe; the pressure pump is disposed in the second syringe, and is used to detect and display the pressure of the liquid inside the second syringe.

[0179] like Figure 8As shown, the third injection unit 170 includes a second container element 171, a second pushing element 172 and an eighth connecting element 173. The second container element 171 is detachably connected to the second injection unit 160, and is used to store liquid, deliver liquid to the second injection unit 160, and evacuate the balloon unit 150; the second pushing element 172 is movably connected to the second container element 171, and is used to push the liquid in the second container element 171 to move to the second injection unit 160 or move on the second container element 171 to evacuate the balloon unit 150; the eighth connecting element 173 is disposed at the distal end of the second container element 171, and is detachably connected to the second injection unit 160.

[0180] Specifically, the eighth connecting element 173 is detachably connected to the seventh connecting element 164 .

[0181] In some of the embodiments, the second container component 171 is a second syringe.

[0182] The size of the second pushing element 172 matches the size of the second container element 171. Generally, the radial size (such as the outer diameter) of the second pushing element 172 is not greater than the radial size (such as the inner diameter) of the second container element 171, and the length of the second pushing element 172 is greater than the length of the second container element 171.

[0183] In some embodiments, the second pushing element 172 includes a second injection piston and a second injection push rod. The second injection piston is movably disposed in the second container element 171; the second injection push rod is connected to the second injection piston, and is used for a user to hold the second injection push rod and push the second injection piston to slide in the second container element 171 to transport the liquid in the second container element 171 or to evacuate the balloon unit 150.

[0184] The materials of the eighth connecting element 173 and the seventh connecting element 164 include but are not limited to snap-fitting and sleeve-fitting.

[0185] The eighth connecting element 173 and the second container element 171 are connected in a fixed connection, wherein the fixed connection includes but is not limited to integral molding.

[0186] The size of the eighth connecting element 173 matches the size of the seventh connecting element 164. Generally, the radial size (eg, outer diameter) of the eighth connecting element 173 is equal to the radial size (eg, inner diameter) of the seventh connecting element 164.

[0187] The size of the eighth connection element 173 matches the size of the second container element 171. Generally, the radial size (eg, outer diameter) of the eighth connection element 173 is smaller than the radial size (eg, outer diameter) of the second container element 171.

[0188] In some of the embodiments, the eighth connecting element 173 is an eighth connecting head.

[0189] The use of the utility model:

[0190] (I) Preparation:

[0191] 1) Connecting the second connecting element 124 to the first connecting element 112, that is, the first container element 121 is connected to the puncture needle element 111;

[0192] 2) connecting the third connecting element 143 and the fourth connecting element 145, that is, fixing the inner core element 141 and the outer sheath element 144 for standby use;

[0193] 3) Connect the eighth connecting element 173 to the seventh connecting element 164 , open the valve element 163 , and inject the liquid in the second container element 171 into the pressure pump element 165 .

[0194] 4) Connect the sixth connecting element 162 to the fifth connecting element 155 , open the valve element 163 , use the second container element 171 to evacuate the balloon element 152 , the first catheter element 151 , and the third catheter element 161 , and then close the valve element 163 .

[0195] (ii) Puncture:

[0196] Under ultrasound guidance, the puncture needle element 111 is punctured at a position about 2 cm proximal to the palm side of the wrist joint. The puncture needle element 111 enters the transverse carpal ligament and the radial side of the median nerve. Then a small amount of the medicine solution (a mixture of saline and lidocaine) in the first container element 121 is injected into the affected area to ensure that the needle tip of the puncture needle element 111 is located between the transverse carpal ligament and the median nerve.

[0197] (III) Insertion of guidewire element 131

[0198] The guide wire element 131 is passed through the puncture needle element 111 along the channel element 123 and placed at the needle tip position of the puncture needle element 111. After ultrasonic monitoring shows that the first marking element 132 is located at the needle tip position of the puncture needle element 111, the puncture needle element 111 is removed together with the first injection unit 120.

[0199] (IV) Expansion

[0200] 1) Holding the gripping element 142 tightly, inserting the inner core element 141 together with the outer sheath element 144 into the patient's affected part along the guide wire element 131, preliminarily expanding the path tissue between the patient's transverse carpal ligament and the median nerve, then releasing the connection between the third connecting element 143 and the fourth connecting element 145, and pulling out the inner core element 141;

[0201] 2) passing the first catheter element 151 through the guidewire element 131 and entering the affected part along the outer sheath element 144; when ultrasound identifies that the balloon element 152 is located at the affected part and the groove element 153 is facing the transverse carpal ligament, pulling out the outer sheath element 144 and the guidewire element 131;

[0202] 3) Open the valve element 163, use the pressure pump element 165 to let the liquid (such as saline) enter the first catheter element 151 along the third catheter element 161 to fill the balloon element 152, observe the pressure value displayed by the pressure pump element 165 and the size of the balloon element 152 displayed by ultrasound, and when the balloon element 152 separates the transverse carpal ligament from the median nerve, the transverse carpal ligament is fully exposed, and the groove element 153 is facing the transverse carpal ligament, stop filling the balloon element 152 and close the valve element 163. During the operation, the groove element 153 leaves a cutting space for cutting the transverse carpal ligament.

[0203] (V) End of the operation

[0204] After the operation is completed, the valve component 163 is opened, and the liquid inside the balloon component 152 and the first catheter component 151 is sucked out by the pressure pump component 165, and the first catheter component 151 and the balloon component 152 are pulled out.

[0205] The technical effects of the utility model are as follows:

[0206] By setting the puncture unit to an arc-shaped structure, it is easier to puncture into the transverse carpal ligament and guide the guide wire unit to the affected area. The first injection unit injects liquid to ensure the accuracy of the position of the puncture unit. The expansion unit performs a preliminary expansion of the tissue on the path from the skin to the target point. The guide wire unit is then used to introduce the balloon unit. The balloon unit is filled with liquid through the second injection unit to increase the volume of the balloon unit, thereby effectively separating the transverse carpal ligament and the median nerve. At the same time, the balloon unit is set to a groove structure to reserve cutting space when cutting the transverse carpal ligament. Not only can the cutting depth and range be accurately controlled to completely relieve compression, but also accidental injury to the median nerve can be avoided, thereby solving the problems of ineffective separation of the transverse carpal ligament and the median nerve, inability to completely relieve compression, and inability to protect the median nerve due to excessive cutting.

[0207] Example 2

[0208] This embodiment is a variation of Embodiment 1.

[0209] like Fig. 9 As shown, the balloon unit 150 further includes a positioning element 156. The positioning element 156 is disposed on the first catheter element 151 and corresponds to the position of the groove element 153, and is used to locate the direction of the groove element 153.

[0210] In some of the embodiments, the positioning element 156 is disposed at the connection position between the first catheter element 151 and the second catheter element 154 .

[0211] The connection between the positioning element 156 and the second conduit element 154 is fixed connection or detachable connection. The fixed connection includes but is not limited to integral molding; the detachable connection includes but is not limited to snap connection and sleeve connection.

[0212] The size of the positioning element 156 matches the size of the second catheter element 154. Generally, the radial dimension (eg, outer diameter) of the positioning element 156 is smaller than the radial dimension (eg, outer diameter) of the second catheter element 154.

[0213] In some embodiments, the material of the positioning element 156 includes but is not limited to plastic.

[0214] In some embodiments, the positioning element 156 is a positioning block or a positioning mark.

[0215] Furthermore, if Fig. 9 As shown, the balloon unit 150 further includes a second marking element 157. The second marking element 157 is disposed at the distal end of the balloon element 152 to assist imaging equipment in identifying the position of the balloon element 152.

[0216] In some of the embodiments, the second marking element 157 is a metal coating disposed on the inner edge surface of the balloon element 152 .

[0217] The second marking element 157 is connected to the balloon element 152 by fixed connection, wherein the fixed connection method includes but is not limited to heat pressing.

[0218] The size of the second marker element 157 matches the size of the balloon member 152. Generally, the radial dimension (eg, outer diameter) of the second marker element 157 is smaller than the radial dimension (eg, outer diameter) of the balloon member 152.

[0219] In some of the embodiments, the second marking element 157 is a metal marking.

[0220] The technical effects of this embodiment are as follows:

[0221] By setting a positioning element, when the first catheter element is inserted into the affected area to separate the transverse carpal ligament from the median nerve, the direction of the groove can be determined by the position and direction of the positioning element, thereby ensuring the correct position and direction of the groove element; by setting a second marking element, the position of the balloon element can be better identified, thereby ensuring the accuracy of the balloon element placement position and improving the efficiency of balloon placement.

[0222] Example 3

[0223] This embodiment is a variation of Embodiments 1 and 2.

[0224] like Fig.10 As shown, the balloon dilatation device 100 further includes a fixing unit 180 . The fixing unit 180 is worn on the patient's wrist and is detachably connected to the balloon unit 150 to fix the balloon unit 150 .

[0225] like Fig.11 As shown, the fixing unit 180 includes a wearable element 181, an adjusting element 182 and a fixing element 183. The wearable element 181 is removably worn on the patient's wrist; the adjusting element 182 is disposed at the end of the wearable element 181, and is used to adjust and lock the size of the wearable element 181 to adapt to different patients; the fixing element 183 is disposed at the end of the wearable element 181, and is detachably connected to the wearable element 181 and the balloon unit 150, and is used to fix the second end of the balloon unit 150 to the patient's wrist.

[0226] Specifically, the fixing element 183 is detachably connected to the proximal end section of the first catheter element 151 .

[0227] In some embodiments, the wearable element 181 has a length ranging from 10 cm to 30 cm and a width ranging from 2 cm to 5 cm.

[0228] In some embodiments, the material of the wearable element 181 includes but is not limited to plastic.

[0229] In some of the embodiments, the wearable element 181 is a disposable item.

[0230] In some of the embodiments, the wearable element 181 is a bracelet.

[0231] The connection between the adjusting element 182 and the wearable element 181 is a fixed connection, wherein the fixed connection method includes but is not limited to bonding.

[0232] The adjusting element 182 is disposed at at least one end of the wearable element 181. Specifically, the following embodiments are included:

[0233] 1) There is one adjusting element 182, and it is disposed on a first side surface of a first end of the wearable element 181;

[0234] 2) There is one adjusting element 182, and it is disposed on the second side surface of the second end of the wearable element 181;

[0235] 3) There are two adjusting elements 182 , one is disposed on a first side of a first end of the wearable element 181 , and the other is disposed on a second side of a second end of the wearable element 181 .

[0236] The size of the adjusting element 182 matches the size of the wearable element 181. Generally, the length of the adjusting element 182 is smaller than the length of the wearable element 181, and the width of the adjusting element 182 is smaller than the width of the wearable element 181.

[0237] In some embodiments, the adjustment element 182 is a first adhesive tape. Specifically, the adjustment element 182 includes a first adhesive layer and a covering layer. The first adhesive layer is disposed at the end of the wearable element 181 to adjust the circumference of the wearable element 181 and fix the circumference of the wearable element 181; the covering layer is removably disposed on the outer edge of the first adhesive layer to cover the first adhesive layer when not in use to prevent the first adhesive layer from sticking to other objects.

[0238] The connection between the fixing element 183 and the wearable element 181 is a detachable connection, wherein the detachable connection includes but is not limited to adhesion.

[0239] The size of the fixing element 183 matches the size of the wearable element 181. Generally, the length of the fixing element 183 is smaller than the length of the wearable element 181, and the width of the fixing element 183 is smaller than the width of the wearable element 181.

[0240] The size of the fixing element 183 matches the size of the second conduit element 154. Generally, the length of the fixing element 183 is greater than the width of the second conduit element 154, and the width of the fixing element 183 is less than the length of the second conduit element 154.

[0241] In some of the embodiments, the fixing element 183 is a second adhesive tape.

[0242] The method of using this embodiment is as follows:

[0243] When in use, the fixing element 183 is torn off from the wearable element 181 , and then the fixing element 183 is pasted on the second catheter element 154 and fixed on the wearable element 181 , and then the wearable element 181 is wrapped around the patient's arm and fixed on the patient's arm through the adjusting element 182 .

[0244] The technical effects of this embodiment are as follows:

[0245] By setting up a fixing unit, the balloon unit can be fixed to the patient's arm to prevent the balloon unit from being displaced during the operation and affecting the accuracy of the operation position.

[0246] Example 4

[0247] This embodiment relates to a balloon dilatation system.

[0248] like Fig.12As shown, a balloon dilatation system comprises the balloon dilatation device 100 and the real-time monitoring device 200 as described in any one of Embodiments 1 to 3. The real-time monitoring device 200 is used to monitor and observe the position and state of the balloon dilatation device 100 at the affected part of the patient in real time.

[0249] Specifically, the real-time monitoring device 200 is used to monitor the puncture position of the puncture unit 110, the placement position of the guide wire unit 130, the expansion path of the expansion unit 140, the placement position of the balloon unit 150 and the status of the balloon unit 150 to ensure that the operation proceeds smoothly.

[0250] In some of the embodiments, the real-time monitoring device 200 includes but is not limited to an ultrasound device and a nerve monitoring device.

[0251] The technical effects of this embodiment are as follows:

[0252] By setting up a real-time monitoring device, the state of the affected area and the position and state of the instruments placed on the affected area can be monitored in real time.

[0253] The above description is only a preferred embodiment of the present invention, and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A balloon dilatation device for isolating the transverse carpal ligament and the median nerve, characterized in that: include: A puncture unit, the puncture unit is arranged in an arc shape and is used for puncture; a first injection unit, which is detachably connected to the puncture unit and is used to inject a liquid medicine into an affected area through the puncture unit; A guide wire unit, the guide wire unit removably passing through the puncture unit and the first injection unit, and used to enter the affected part through the puncture unit and the first injection unit to determine the position of the affected part; An expansion unit, the expansion unit is removably arranged on the guide wire unit, and is used to enter the affected area along the guide wire unit to expand the tissue on the path from the patient's skin to the target point; A balloon unit, wherein the balloon unit is removably sleeved on the guide wire unit, wherein a groove is provided at the distal end of the balloon unit and faces the transverse carpal ligament, and is used to enter the affected area along the guide wire unit to separate the transverse carpal ligament from the median nerve; A second injection unit, which is detachably connected to the proximal section of the balloon unit and is used to inject liquid into the balloon unit to fill the distal section of the balloon unit and to aspirate the liquid in the balloon unit to shrink the distal section of the balloon unit; A third injection unit is detachably connected to the second injection unit and is used for conveying liquid to the second injection unit and evacuating the balloon unit.

2. The balloon dilatation device according to claim 1, characterized in that: The puncture unit comprises: A puncture needle element, which is arranged in an arc shape, and the guide wire unit is removably arranged inside the puncture needle element for puncture; a first connecting element, which is disposed at the proximal end of the puncture needle element and is detachably connected to the first injection unit; and / or The first injection unit comprises: a first container element, which is detachably connected to the puncture unit and is used to store liquid medicine and inject the liquid medicine into the affected part of the patient through the puncture unit; a first pushing element, the first pushing element being movably connected to the first container element and being used for pushing the medical solution in the first container element toward the puncture unit; A channel element, the channel element is arranged through the first pushing element, and the interior of the channel element can removably pass through the guide wire unit; A second connecting element is arranged at the distal end section of the first container element and is detachably connected to the puncture unit.

3. The balloon dilatation device according to claim 1, characterized in that: The guide wire unit comprises: A guide wire element, which is removably disposed inside the puncture unit and is used to enter the affected part through the puncture unit to determine the position of the affected part; A first marking element is disposed at the distal end of the guidewire element and is used to assist imaging equipment in identifying the position of the distal end of the guidewire element.

4. The balloon dilatation device according to claim 1, characterized in that: The expansion unit comprises: An inner core element, the inner core element is removably arranged to cover the guide wire unit and is used to enter the affected area along the guide wire unit; A gripping element, which is disposed at the proximal end of the inner core element and is used for gripping; a third connecting element, the third connecting element being disposed at a proximal end section of the inner core element; An outer sheath element, which is sleeved on the outside of the inner core element and is used to expand the tissue on the path from the patient's skin to the target point; A fourth connecting element is arranged at the proximal end section of the outer sheath element and is detachably connected to the third connecting element.

5. The balloon dilatation device according to claim 1, characterized in that: The balloon unit comprises: A first catheter element, which is removably sleeved on the guide wire unit and is in communication with the second injection unit, and is used to enter the affected area along the guide wire unit and deliver liquid; A balloon component, which is disposed at the distal end of the first catheter component and is in communication with the first catheter component, and is used to separate the transverse carpal ligament and the median nerve when the balloon is filled; A groove element, the groove element is arranged on the balloon element, and is used to reserve a cutting space when cutting the transverse carpal ligament; a second catheter element, which is disposed at a proximal end section of the first catheter element and is in communication with the second injection unit and is used for delivering liquid to the balloon element; A fifth connecting element is disposed at an end of the proximal section of the second catheter element and connected to the second injection unit.

6. The balloon dilatation device according to claim 5, characterized in that: The balloon unit also includes: a positioning element, the positioning element being arranged on the first conduit element and corresponding to the position of the groove element, and being used for positioning the direction of the groove element; and / or A second marking element is disposed at the distal end of the balloon element and is used to assist imaging equipment in identifying the position of the balloon element.

7. The balloon dilatation device according to claim 1, characterized in that: The second injection unit comprises: a third catheter element, the third catheter element being communicated with the balloon unit and the third injection unit respectively; a sixth connecting element, which is disposed at the distal end section of the third catheter element and is detachably connected to the balloon unit; a seventh connecting element, the seventh connecting element being arranged at a distal end section of the third catheter element and being detachably connected to the third injection unit; a valve element, the valve element being arranged at a distal end section of the third catheter element and being used for controlling the communication states between the third catheter element and the balloon unit and the third injection unit respectively; a pressure pump element, the pressure pump element being in communication with the proximal end section of the third catheter element and being used for obtaining the liquid delivered by the third injection unit and delivering the liquid to the balloon unit; and / or The third injection unit comprises: a second container element, which is detachably connected to the second injection unit and is used for storing liquid, delivering liquid to the second injection unit, and evacuating the balloon unit; a second pushing element, which is movably connected to the second container element and is used to push the liquid in the second container element toward the second injection unit or to evacuate the balloon unit; An eighth connecting element is disposed at a distal end section of the second container element and is detachably connected to the second injection unit.

8. The balloon dilatation device according to any one of claims 1 to 7, characterized in that: Also includes: A fixing unit is worn on the patient's wrist and is detachably connected to the balloon unit to fix the balloon unit.

9. The balloon dilatation device according to claim 8, characterized in that: The fixing unit comprises: a wearable element that is removably wearable on a patient's wrist; An adjusting element, which is disposed at the end of the wearable element and is used to adjust and lock the size of the wearable element to adapt to different patients; A fixing element is arranged at the end of the wearable element and is detachably connected to the wearable element and the balloon unit, respectively, and is used to fix the second end of the balloon unit to the patient's wrist.

10. A balloon dilatation system, characterized in that: include: The balloon dilatation device according to any one of claims 1 to 9; A real-time monitoring device is used to monitor and observe the position and status of the balloon dilatation device at the patient's affected area in real time.

Images