Soft tissue cutting apparatus for percutaneous intervention

Abstract

The present invention relates to a soft tissue cutting apparatus for percutaneous intervention, comprising a cutting assembly and a control assembly. The soft tissue cutting apparatus has the advantages that by means of the cooperation of the control assembly and the cutting assembly, the cutting operation is simplified, the cutting size is controlled, the number of cutting times is reduced, and the surgical efficiency is improved; a cutting unit adopts a guide rail technology, and after a sheath tube unit is positioned, the cutting unit can axially move and cut in the sheath tube unit, ensuring the cutting stability and safety, avoiding a traditional non-guide rail or sheath tube overall moving cutting mode, and achieving linear cutting; the length of a cutting end of the cutting unit is controllable, such that soft tissues with different thicknesses can be cut; one-hand operation is achieved by means of the control assembly, without the cooperation of the other hand or the cooperation of the assistant, saving the labor cost, and facilitating outpatient surgery implementation.

Description

A percutaneous soft tissue cutting device Technical Field

[0001] The present invention relates to the technical field of soft tissue cutting, and in particular to a percutaneous soft tissue cutting device. Background Art

[0002] Soft tissue pain is commonly a clinical syndrome caused by varying degrees of fiber rupture and aseptic inflammation resulting from cumulative or excessive activity in joint capsules, ligaments, muscles, fascia, and other tissues. These symptoms include peripheral nerve entrapment syndrome and pain around tendon insertions. Peripheral nerve entrapment syndrome refers to functional impairment caused by compression of peripheral nerves by surrounding tissues. Clinical symptoms primarily include pain, sensory impairment, motor impairment, and electrophysiological changes. The source of compression is typically the bony canal, inelastic muscle fiber edges, or nerve pathways such as the tendon arch. Common conditions include carpal tunnel syndrome, cubital tunnel syndrome, tarsal tunnel syndrome, piriformis syndrome, and thoracic outlet syndrome. Pain around tendon insertions includes conditions such as golfer's elbow, tennis elbow, gastrocnemius contracture, heel pain caused by plantar fasciitis, torticollis, and equinus in children.

[0003] Clinically, surgical intervention is required for patients who fail conservative treatment, suffer from muscle atrophy, or have severe or space-occupying lesions. The goal is to decompress and release compressed nerves, thereby restoring function. Surgical procedures have evolved from open surgery to minimally invasive surgery, and minimally invasive surgery has evolved from endoscopic surgery to less invasive interventional procedures.

[0004] Regarding ultrasound-guided interventional treatment, there is currently no solution that can accurately locate, stably cut and release soft tissues of varying thicknesses with one hand, and effectively protect nerves and blood vessels.

[0005] Summary of the Invention

[0006] The purpose of the present invention is to address the deficiencies in the prior art and provide a percutaneous soft tissue cutting device that can accurately and stably cut and release soft tissue with one hand, and effectively protect peripheral nerves and blood vessels from damage.

[0007] To achieve the above object, the technical solution adopted by the present invention is:

[0008] In a first aspect, a percutaneous soft tissue cutting device is provided, comprising:

[0009] cutting components;

[0010] A control assembly connected to the cutting assembly for controlling the cutting assembly so as to switch the cutting assembly between a knife-retracting position and a knife-standing position;

[0011] Wherein, the cutting assembly comprises:

[0012] sheath unit;

[0013] a cutting unit, at least a portion of which is disposed within the sheath unit and connected to the control assembly, and configured to cause the cutting unit and the sheath unit to move relative to each other under control of the control assembly, so as to switch the cutting unit between a knife-retracting position and a knife-standing position;

[0014] Wherein, in the knife-retracted position, the cutting end of the cutting unit is located inside the sheath unit; in the knife-standing position, at least a portion of the cutting end of the cutting unit is located outside the distal end of the sheath unit to cut tissue;

[0015] Wherein, the control component includes:

[0016] a housing unit, wherein at least a portion of the cutting assembly is disposed inside the housing unit;

[0017] The knife control unit is arranged in the housing unit and is pivotally connected to the transmission end of the cutting unit, and is used to control the cutting unit so that the cutting unit and the sheath unit move relative to each other and the cutting unit switches between a knife-retracting position and a knife-standing position.

[0018] In some embodiments, the sheath unit comprises:

[0019] a sheath element, wherein at least a portion of the cutting unit is disposed inside the sheath element;

[0020] An opening element is arranged at the distal end section of the sheath element, and is used to move the cutting end of the cutting unit within the opening element under the control of the control component, and to position at least a portion of the cutting end of the cutting unit outside the opening element to cut tissue when the cutting end of the cutting unit is in a vertical knife position.

[0021] In some embodiments, the sheath unit further comprises:

[0022] A scale element is provided on the outer edge surface of the sheath element and is used to indicate the depth of the sheath element penetrating into the tissue.

[0023] In some embodiments, the cutting unit comprises:

[0024] a cutting element movably disposed at the distal end of the sheath unit, wherein when the cutting element is in a knife-retracted position, the cutting element is located inside the distal end of the sheath unit, and when the cutting element is in a knife-up position, at least a portion of the cutting element is located outside the distal end of the sheath unit to cut tissue;

[0025] The first transmission element is connected to the cutting element and the control component respectively, and is used to drive the cutting element to move at the distal end of the sheath unit under the control of the control component, so that the cutting element can switch between the knife-retracting position and the knife-standing position.

[0026] In some embodiments, the cutting unit further comprises:

[0027] A first sliding element is provided at a proximal end portion of the first transmission element and is slidably connected to the manipulation assembly.

[0028] In some embodiments, the housing unit comprises:

[0029] A housing element is provided inside which at least a portion of the cutting assembly is disposed.

[0030] In some embodiments, the housing unit further comprises:

[0031] A first positioning element is provided on the housing element and is located on the moving track of the knife control unit, and is used to limit the moving range of the knife control unit.

[0032] In some embodiments, the knife control unit includes:

[0033] a rotating element, the rotating element being disposed inside the housing unit;

[0034] A knife-controlling element is connected to the rotating element and is pivotally connected to the transmission end of the cutting unit, and is used for rotating under the action of the rotating element.

[0035] In some embodiments, the knife control unit further includes:

[0036] The first actuating element is disposed at the top end of the rotating element and is used to control the rotating element.

[0037] In some embodiments, the knife control unit further includes:

[0038] The second sliding element is arranged on the knife control element, is eccentrically arranged with respect to the rotating element, and is slidably connected with the transmission end of the cutting unit.

[0039] In some embodiments, the knife control unit further includes:

[0040] A damping element is provided at a connection position between the knife control element and the rotating element, and is used to increase damping.

[0041] In some embodiments, the knife control unit further includes:

[0042] A support element is arranged inside the housing unit and is connected to the rotating element and the knife control element respectively.

[0043] In some embodiments, the cutting assembly further comprises:

[0044] A balloon unit, wherein the balloon end of the balloon unit is arranged at the distal end section of the sheath unit and is connected to the control component, and is used to fill the balloon end of the balloon unit to a predetermined state under the control of the control component, or to restore the balloon end of the balloon unit to an initial state under the control of the control component.

[0045] In some embodiments, the balloon unit comprises:

[0046] a balloon component, the balloon component being disposed at the distal end of the sheath unit;

[0047] At least one fluid delivery element, the distal section of the fluid delivery element is connected to the balloon element, and the proximal section of the fluid delivery element is connected to the manipulation component, for delivering a working medium to the balloon element under the manipulation of the manipulation component to fill the balloon element to a predetermined state, or, delivering a working medium to the manipulation component under the manipulation of the manipulation component to restore the balloon element to an initial state.

[0048] In some embodiments, the control component further includes:

[0049] A fluid delivery unit is connected to the balloon unit of the cutting assembly and is used to deliver a working medium to the balloon unit to fill the balloon unit to a predetermined state, or to obtain the working medium delivered by the balloon unit to restore the balloon unit to an initial state.

[0050] In some embodiments, the housing unit further comprises:

[0051] A second positioning element is provided on the housing unit and is detachably connected to the actuating end of the fluid transport unit, and is used to limit the state of the fluid transport unit.

[0052] In some embodiments, the fluid delivery unit includes:

[0053] a storage element, the storage element being in communication with the balloon unit and being used to deliver a working medium to the balloon unit or to obtain the working medium delivered by the balloon unit;

[0054] a second transmission element connected to the storage element;

[0055] A second actuating element is connected to the second transmission element, and is used to actuate the second transmission element to enable the storage element to deliver the working medium to the balloon unit, or to enable the balloon unit to deliver the working medium to the storage element.

[0056] In some embodiments, the fluid delivery unit further comprises:

[0057] A third positioning element is provided at an end portion of the second actuating element and is detachably connected to the housing unit, and is used to limit a state of the second actuating element.

[0058] In some embodiments, the fluid delivery unit further comprises:

[0059] An elastic element is disposed between the storage element and the second transmission element.

[0060] In some embodiments, the fluid delivery unit further comprises:

[0061] A valve element is communicated with the storage element and is used for allowing the working medium to flow in one direction.

[0062] In some embodiments, further comprising:

[0063] A locking assembly is detachably provided on the sheath unit of the cutting assembly and is used to lock the depth of the sheath unit penetrating into the tissue.

[0064] In some embodiments, the locking assembly includes:

[0065] A locking unit is detachably provided on the sheath unit and is used to lock the depth of the sheath unit penetrating into the tissue.

[0066] In some embodiments, the locking unit includes:

[0067] a first locking element removably disposed on the sheath unit;

[0068] A second locking element is removably provided on the sheath unit and detachably connected to the first locking element.

[0069] In a second aspect, a percutaneous soft tissue cutting device is provided, which includes a cutting body and a manipulation component, wherein the cutting body includes a cutting component and an outer sheath having an opening, wherein the opening is located at the distal end of the outer sheath, and under the manipulation of the manipulation component, the cutting component can be moved relative to the outer sheath so that the cutting member of the cutting component moves in the opening to cut the tissue; the cutting component includes a cutting unit and an auxiliary unit, wherein at least a portion of the cutting unit and at least a portion of the auxiliary unit are arranged in the outer sheath; the cutting unit includes the cutting The cutting member is pivotally connected to the distal end section of the transmission member and the auxiliary unit respectively, and the transmission member can move relative to the auxiliary unit; the proximal end section of the transmission member is connected to the control component, and under the control of the control component, the transmission member can cause the cutting member to pivot relative to the auxiliary unit to switch the cutting member between a knife-retracting position and a knife-standing position; in the knife-retracting position, the cutting member is accommodated in the internal space of the outer sheath tube; in the knife-standing position, at least a portion of the cutting member protrudes from the opening and is located outside the outer sheath tube.

[0070] The above technical solution simplifies the vertical blade structure of the cutting device, facilitating the cutting operation. Furthermore, the transmission element pivots the cutting element relative to the auxiliary unit, switching it between a retracted position and an upright position. This facilitates control of the cutting edge size of the cutting element and allows the use of a longer cutting element for effective cutting of thicker tissue, reducing the number of cuts and improving surgical efficiency.

[0071] In some embodiments, the transmission member includes an intermediate member and a force-applying member, wherein the intermediate member is pivotally connected to the distal end of the force-applying member and the cutting member, respectively, and the proximal end of the force-applying member is connected to the control assembly. This arrangement facilitates position switching of the cutting member and reduces resistance associated with position switching.

[0072] In some embodiments, the device further includes a retaining structure capable of retaining the cutting member in a predetermined position. This facilitates adjustment of the cutting depth, making it more suitable for individual cutting needs and improving the reliability of the cutting operation.

[0073] In some embodiments, the control assembly includes a knife control unit, which is connected to the proximal end section of the transmission member and can control the transmission member to cause the cutting member to pivot relative to the auxiliary unit; the knife control unit includes a rotating axis, around which the knife control unit can rotate to control the transmission member to cause the cutting member to pivot relative to the auxiliary unit.

[0074] In some embodiments, one of the blade control unit and the proximal end section of the transmission member includes a slide groove, and the other includes a sliding member. The slide groove has an arcuate surface that is eccentrically disposed relative to the rotation axis. The sliding member cooperates with the arcuate surface so that when the blade control unit is rotated, the sliding member slides along the arcuate surface to manipulate the transmission member to cause the cutting member to pivot relative to the auxiliary unit. This method facilitates vertical blade operation and prevents misoperation of the cutting angle during tissue cutting.

[0075] In some embodiments, the holding structure is provided on the chute. This method can simplify the holding structure and facilitate the holding operation.

[0076] In some embodiments, the knife control unit is provided with a tooth structure, and the proximal section of the transmission member is provided with a rack. By rotating the knife control unit, the transmission member is controlled to cause the cutting member to pivot relative to the auxiliary unit under the cooperation of the tooth structure and the rack.

[0077] In some embodiments, the manipulation assembly further comprises an actuating unit, which is movable relative to the housing of the device to cause the cutting member to cut the target tissue in a cutting direction. This facilitates the tissue cutting operation.

[0078] In some embodiments, the actuating unit includes a manipulation member and a connecting member, the manipulation member is connected to the knife control unit via the connecting member, and a rotation axis of the knife control unit is pivotally connected to the connecting member.

[0079] In some embodiments, the proximal end section of the auxiliary unit is connected to the connecting member. This method facilitates the knife-retracting and knife-lifting operations of the cutting member and ensures reliability.

[0080] In some embodiments, the retaining structure further includes a first positioning assembly and a first positioning port, one of the actuating unit and the knife control unit includes the first positioning assembly, and the other of the actuating unit and the knife control unit includes the first positioning port, and when the cutting member is located in the predetermined position, at least a portion of the first positioning assembly is located in the first positioning port to limit the rotation of the knife control unit.

[0081] In some embodiments, the manipulation assembly further includes a second positioning assembly and a second positioning opening, wherein the second positioning assembly and the second positioning opening cooperate to maintain the positioning of the knife control unit at a target position. This approach can prevent unintentional tissue cutting and improve cutting safety.

[0082] In some embodiments, the second positioning assembly includes an actuator, a first limiting member, and a first elastic member. The ends of the elastic member are supported by the actuator and the operating member of the actuator unit, respectively. The actuator and the limiting member are connected to each other on either side of the operating member. The second positioning opening is located on the movement trajectory of the operating member. When the knife-control unit is at a target position, the elastic member causes the limiting member to cooperate with the second positioning opening to restrict movement of the actuator unit. When the knife-control unit needs to move away from the target position, pressing the actuator causes the limiting member to disengage from the second positioning opening. This approach facilitates one-handed operation and improves operational convenience.

[0083] In some embodiments, the cutting body also includes a balloon assembly, which includes at least one balloon and a fluid pipeline, and the balloon is located at the distal end of the outer sheath and is fluidically connected to the fluid pipeline; the manipulation assembly also includes a fluid conveying mechanism, which includes the braking unit, the transmission unit and the storage unit, and the storage unit is fluidically connected to the fluid pipeline. The pivotal movement of the braking unit can actuate the transmission unit to allow the working medium in the storage unit to be conveyed to the balloon, thereby filling the balloon to a predetermined state.

[0084] In some embodiments, the control assembly further includes a locking unit movably disposed on the housing; when the balloon is inflated to the predetermined state, the locking unit is capable of limiting the pivotal movement of the braking unit to prevent the working medium in the balloon from being discharged. This approach improves operational convenience.

[0085] In some embodiments, the locking unit includes a second limiter and a second elastic member, the second limiter can be movably arranged on the housing of the device, the second elastic member is connected to the second limiter, and when the balloon is inflated to the predetermined state, the second elastic member can provide a biasing force to the second limiter to maintain the locking state of the second limiter and the braking unit.

[0086] In some embodiments, the locking unit further includes an unlocking member, and moving the unlocking member can drive the second limiting member to deflect and disengage from the braking unit.

[0087] In some embodiments, an interface capable of connecting to an external device is provided between the storage unit and the fluid pipeline.

[0088] The present invention adopts the above technical solution, which has the following technical effects compared with the prior art:

[0089] 1) The coordination of the control component and the cutting component simplifies the cutting operation, controls the cutting size, reduces the number of cuts, and improves surgical efficiency;

[0090] 2) The cutting unit adopts guide rail technology. After the sheath unit is positioned, the cutting unit can move axially within the sheath unit to cut, ensuring cutting stability and safety, avoiding the traditional cutting method without guide rails or the entire sheath moving, and realizing linear cutting;

[0091] 3) The cutting end of the cutting unit is controllable in length, allowing it to cut soft tissues of varying thicknesses;

[0092] 4) The control component enables single-handed operation without the need for the other hand or an assistant, saving labor costs and facilitating outpatient surgery.

[0093] 5) The cutting assembly is equipped with a balloon unit. When the balloon unit is not expanded, the diameter of the sheath unit will not increase, which can ensure a smaller incision. When the balloon unit is expanded, it can open the nerves near the sheath unit to increase safety, increase the pressure in the soft tissue cavity, and improve cutting efficiency. After the pressure in the soft tissue cavity is increased, the cutting end of the cutting unit can be stabilized to prevent the cutting end from rotating.

[0094] 6) The cutting depth can be effectively positioned by utilizing the cooperation between the locking component and the cutting component. BRIEF DESCRIPTION OF THE DRAWINGS

[0095] FIG1 is a schematic diagram of a soft tissue cutting device according to an embodiment of the present invention (I);

[0096] FIG2 is a partial cross-sectional view (1) of a soft tissue cutting device according to an embodiment of the present invention;

[0097] FIG3 is a schematic diagram of a cutting assembly according to an embodiment of the present invention (I);

[0098] FIG4 is a schematic diagram of a sheath tube unit according to an embodiment of the present invention;

[0099] FIG5 is a schematic diagram of a cutting unit according to an embodiment of the present invention;

[0100] FIG6 is a schematic diagram of a control assembly according to an embodiment of the present invention (I);

[0101] FIG7 is a partial cross-sectional view (I) of a control assembly according to an embodiment of the present invention;

[0102] FIG8 is a schematic diagram of a shell element according to an embodiment of the present invention (I);

[0103] FIG9 is a schematic diagram of a knife control unit according to an embodiment of the present invention (I);

[0104] FIG10 is a schematic diagram of a knife control unit according to an embodiment of the present invention (II);

[0105] FIG11 is a schematic diagram of a knife control unit according to an embodiment of the present invention (III);

[0106] FIG12 is a schematic diagram of a locking assembly according to an embodiment of the present invention;

[0107] FIG13 is a schematic diagram of a soft tissue cutting device according to an embodiment of the present invention (II);

[0108] FIG14 is a partial cross-sectional view (II) of a soft tissue cutting device according to an embodiment of the present invention;

[0109] FIG15 is a schematic diagram of a cutting assembly according to an embodiment of the present invention (II);

[0110] FIG16 is a schematic diagram of a balloon unit according to an embodiment of the present invention;

[0111] FIG17 is a schematic diagram of a control assembly according to an embodiment of the present invention (II);

[0112] FIG18 is a partial cross-sectional view (II) of a control assembly according to an embodiment of the present invention;

[0113] FIG19 is a schematic diagram of a shell element according to an embodiment of the present invention (II);

[0114] FIG20 is a schematic diagram of a fluid delivery unit according to an embodiment of the present invention;

[0115] FIG21 is an exploded view of a fluid delivery unit according to an embodiment of the present invention;

[0116] FIG22 is a schematic diagram of a soft tissue cutting device;

[0117] FIG23 is a schematic diagram of the interior of the soft tissue cutting device;

[0118] FIG24 is a partial enlarged schematic diagram of point A in FIG23;

[0119] Figure 25 is a schematic diagram of the cutting member in the vertical position;

[0120] FIG26 is a schematic diagram showing the internal state of the control assembly when the balloon is inflated to a predetermined state;

[0121] FIG27 is a schematic diagram showing the coordination of the various components when the cutting member is in the vertical position;

[0122] FIG28 is a schematic diagram of the cooperation between the actuating unit and the second positioning assembly;

[0123] FIG29 is a schematic diagram showing the internal state of the control assembly when the balloon is in a deflated state;

[0124] FIG30 is a schematic diagram of the state in which the locking unit and the braking unit cooperate;

[0125] FIG31 is a schematic diagram of the soft tissue cutting device after cutting tissue.

[0126] The accompanying drawings are as follows:

[0127] Reference numerals of Example 1 to Example 2:

[0128] 1000, cutting assembly; 1100, sheath unit; 1110, sheath element; 1111, first tube; 1112, second tube; 1120, opening element; 1130, scale element; 1200, cutting unit; 1210, cutting element; 1220, first transmission element; 1221, intermediate element; 1222, force-applying element; 1223, accommodating space; 1224, channel element; 1230, first sliding element; 1300, balloon unit; 1310, balloon element; 1311, first balloon element; 1312, second balloon element; 1320, fluid transport element;

[0129] 2000, control assembly; 2100, housing unit; 2110, housing element; 2111, first housing element; 2112, second housing element; 2120, first positioning element; 2121, rotating positioning element; 2122, moving positioning element; 2130, second positioning element; 2200, knife control unit; 2210, rotating element; 2220, knife control element; 2230, first actuating element; 2240, second sliding element; 2250, damping element ; 2260, support element; 2261, first support element; 2262, second support element; 2300, fluid delivery unit; 2310, storage element; 2311, injection container element; 2312, input interface element; 2313, output interface element; 2314, pushing element; 2315, piston element; 2320, second transmission element; 2330, second actuating element; 2340, third positioning element; 2350, elastic element; 2360, valve element;

[0130] 3000, locking assembly; 3100, locking unit; 3110, first locking element; 3120, second locking element;

[0131] Reference numerals of Example 3:

[0132] 1. Cutting body; 11. Cutting assembly; 111. Cutting unit; 1111. Cutting member; 1112. Transmission member; 11121. Intermediate member; 11122. Force-applying member; 11123. Accommodating space; 11124. Sliding member; 112. Auxiliary unit; 1121. Restricting member; 12. Outer sheath; 121. Opening; 13. Balloon assembly; 131. Balloon; 132. Fluid conduit;

[0133] 2. Control assembly; 21. Fluid conveying mechanism; 211. Braking unit; 212. Transmission unit; 213. Storage unit; 2131. Conveying interface; 214. Three-way connector; 215. Elastomer; 23. Actuating unit; 231. Control member; 232. Connecting member; 233. First positioning assembly; 24. Knife control unit; 241. Rotating shaft; 242. Slide groove; 243. First positioning port; 25. Housing; 26. Second positioning port; 27. Locking unit; 271. Second limiting member; 272. Second elastic member; 273. Unlocking member; 28. Second positioning assembly; 281. Actuating member; 282. First elastic member; 283. First limiting member. DETAILED DESCRIPTION

[0134] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts shall fall within the scope of protection of the present invention.

[0135] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0136] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but they are not intended to limit the present invention.

[0137] Example 1

[0138] This embodiment relates to the soft tissue cutting device of the present invention.

[0139] An exemplary embodiment of the present invention, as shown in Figures 1 and 2, is a percutaneous soft tissue cutting device comprising a cutting assembly 1000 and a control assembly 2000. The control assembly 2000 is connected to the cutting assembly 1000 and is used to control the cutting assembly 1000 to switch the cutting assembly 1000 between a retracted position and an upright position.

[0140] When the cutting assembly 1000 is in the upright position, the cutting assembly 1000 can cut tissue.

[0141] As shown in FIG3 , the cutting assembly 1000 includes a sheath unit 1100 and a cutting unit 1200. At least a portion of the cutting unit 1200 is disposed within the sheath unit 1100 and is connected to the control assembly 2000. Under the control of the control assembly 2000, the cutting unit 1200 and the sheath unit 1100 move relative to each other, thereby switching the cutting unit 1200 between a retracted position and an upright position.

[0142] In which, in the retracted position, the cutting end of the cutting unit 1200 is located inside the sheath unit 1100; in the upright position, at least a portion of the cutting end of the cutting unit 1200 is located outside the distal end of the sheath unit 1100 to cut the tissue.

[0143] As shown in FIG4 , the sheath unit 1100 includes a sheath element 1110 and an opening element 1120. At least a portion of the cutting unit 1200 is disposed within the sheath element 1110; the opening element 1120 is disposed at the distal end of the sheath element 1110 and is configured to move the cutting end of the cutting unit 1200 within the opening element 1120 under the control of the control assembly 2000, and to position at least a portion of the cutting end of the cutting unit 1200 outside the opening element 1120 to cut tissue when the cutting end of the cutting unit 1200 is in the upright position.

[0144] In some embodiments, the sheath element 1110 includes a first tube 1111 and a second tube 1112. The first tube 1111 has at least a portion of the cutting unit 1200 disposed therein, and the distal end of the first tube 1111 is provided with an opening element 1120. The distal end of the second tube 1112 is connected to the proximal end of the first tube 1111, and the proximal end of the second tube 1112 is connected to the manipulation assembly 2000. At least a portion of the cutting unit 1200 is disposed therein.

[0145] The first pipe 1111 is a hollow structure.

[0146] Generally, the radial dimension (such as the inner diameter) of the inner edge surface of the first tube 1111 remains unchanged.

[0147] In some embodiments, the radial dimension (e.g., outer diameter) of the outer edge surface of the proximal end section of the first tube 1111 increases gradually from the proximal end section of the first tube 1111 to the distal end section of the first tube 1111. This arrangement is intended to facilitate the connection between the proximal end section of the first tube 1111 and the distal end section of the second tube 1112.

[0148] The second pipe 1112 is a hollow structure.

[0149] Generally, the radial dimension (such as the inner diameter) of the inner edge surface of the second tube 1112 remains unchanged.

[0150] In some embodiments, the radial dimension (e.g., outer diameter) of the outer edge surface of the distal end section of the second tube 1112 increases gradually from the distal end section of the second tube 1112 to the proximal end section of the second tube 1112. This arrangement is intended to facilitate the connection between the proximal end section of the first tube 1111 and the distal end section of the second tube 1112.

[0151] The size of the second pipe 1112 matches the size of the first pipe 1111. Generally, the radial dimension of the inner edge surface of the second pipe 1112 is approximately equal to the radial dimension of the inner edge surface of the first pipe 1111, and the radial dimension of the outer edge surface of the second pipe 1112 is approximately equal to the radial dimension of the outer edge surface of the first pipe 1111.

[0152] Generally, after the second pipe member 1112 is connected to the first pipe member 1111 , the outer edge surface of the second pipe member 1112 is substantially coplanar with the outer edge surface of the first pipe member 1111 .

[0153] Furthermore, the sheath unit 1100 further includes a scale element 1130. The scale element 1130 is disposed on the outer edge of the sheath element 1110 to indicate the depth of the sheath element 1110 penetrating into the tissue.

[0154] Specifically, the scale element 1130 is disposed on the outer edge surface of the second tube 1112 .

[0155] Generally, the scale elements 1130 increase in number from the distal end section of the second tube 1112 to the proximal end section of the second tube 1112 .

[0156] Typically, the unit of the scale element 1130 is centimeters.

[0157] As shown in FIG5 , the cutting unit 1200 includes a cutting element 1210 and a first transmission element 1220. The cutting element 1210 is movably disposed at the distal end of the sheath unit 1100. When the cutting element 1210 is in the retracted position, the cutting element 1210 is located inside the distal end of the sheath unit 1100. When the cutting element 1210 is in the upright position, at least a portion of the cutting element 1210 is located outside the distal end of the sheath unit 1100 to cut tissue. The first transmission element 1220 is connected to the cutting element 1210 and the control assembly 2000, respectively, and is used to drive the cutting element 1210 to move at the distal end of the sheath unit 1100 under the control of the control assembly 2000, so as to switch the cutting element 1210 between the retracted position and the upright position.

[0158] Specifically, at least a portion of the cutting element 1210 is disposed inside the sheath element 1110 and may protrude from the opening element 1120 ; at least a portion of the first transmission element 1220 is disposed inside the sheath element 1110 .

[0159] More specifically, at least a portion of the cutting element 1210 is disposed inside the first tube 1111 ; at least a portion of the first transmission element 1220 is disposed inside the first tube 1111 ; and at least a portion of the first transmission element 1220 is disposed inside the second tube 1112 .

[0160] In some embodiments, the proximal end section of the first transmission element 1220 is located outside the proximal end section of the second tube 1112 , that is, the proximal end section of the first transmission element 1220 protrudes from the proximal end section of the second tube 1112 .

[0161] Generally, in the upright position, at least a portion of the cutting element 1210 is protruded from the opening element 1120 .

[0162] In some embodiments, the cutting element 1210 is a cutting blade.

[0163] In some embodiments, the first transmission element 1220 includes an intermediate member 1221 and a force-applying member 1222. The distal end of the intermediate member 1221 is pivotally connected to the cutting element 1210; the distal end of the force-applying member 1222 is pivotally connected to the proximal end of the intermediate member 1221, and the proximal end of the force-applying member 1222 is connected to the control assembly 2000, so as to drive the cutting element 1210 to move within the sheath unit 1100 via the intermediate member 1221 under the control of the control assembly 2000.

[0164] When the cutting element 1210 switches from the knife-retracting position to the knife-standing position, the force-applying member 1222 moves from its distal end to its proximal end, causing the middle piece 1221 to rotate clockwise around the pivotal connection position between the middle piece 1221 and the force-applying member 1222, thereby causing the cutting element 1210 to rotate counterclockwise around the pivotal connection position between the cutting element 1210 and the middle piece 1221, until the cutting element 1210 is in the knife-standing position.

[0165] When the cutting element 1210 switches from the upright position to the retracted position, the force-applying member 1222 moves from its proximal end to its distal end, causing the middle piece 1221 to rotate counterclockwise around the pivotal connection position between the middle piece 1221 and the force-applying member 1222, thereby causing the cutting element 1210 to rotate clockwise around the pivotal connection position between the cutting element 1210 and the middle piece 1221, until the cutting element 1210 is in the retracted position.

[0166] In some embodiments, the intermediate member 1221 is a hinge rod.

[0167] In some embodiments, the force applying member 1222 is a push rod.

[0168] Furthermore, the first transmission element 1220 further includes an accommodating space 1223 , wherein the accommodating space 1223 is provided at the distal end of the middle piece 1221 for accommodating at least a portion of the cutting element 1210 .

[0169] Generally, in the knife-retracted position, the cutting element 1210 is located inside the accommodating space 1223 ; in the knife-up position, part of the cutting element 1210 is located inside the accommodating space 1223 .

[0170] Furthermore, the first transmission element 1220 further includes a channel member 1224 , wherein the channel member 1224 is disposed inside the sheath unit 1100 , and a force applying member 1222 is disposed inside the channel member 1224 .

[0171] Specifically, the channel member 1224 is disposed inside the sheath element 1110 .

[0172] More specifically, the channel member 1224 is disposed inside the second tube member 1112 .

[0173] The purpose of providing the channel member 1224 is to limit the movement range of the force applying member 1222 so that the force applying member 1222 can only reciprocate along the axial direction of the channel member 1224 .

[0174] Generally, the proximal end section of the force applying member 1222 is located outside the proximal end section of the channel member 1224 , that is, the proximal end section of the force applying member 1222 is protruded from the proximal end section of the channel member 1224 .

[0175] Generally, when the force-applying member 1222 moves from its proximal end section to its distal end section, the proximal end section of the force-applying member 1222 is always located outside the proximal end section of the channel member 1224 .

[0176] In some embodiments, the axial dimension of the channel member 1224 is greater than the axial dimension of the second tube member 1112. For example, the distal end of the channel member 1224 is located outside the distal end of the second tube member 1112, and the proximal end of the channel member 1224 is located outside the proximal end of the second tube member 1112.

[0177] In some embodiments, the distal end of the channel member 1224 is pivotally connected to the cutting element 1210. Generally, when the intermediate member 1221 drives the cutting element 1210 to rotate, the cutting element 1210 rotates around the pivotal connection position between the intermediate member 1221 and the channel member 1224.

[0178] In some embodiments, the channel member 1224 is a fixed tube.

[0179] Furthermore, the cutting unit 1200 further includes a first sliding element 1230 , wherein the first sliding element 1230 is disposed at the proximal end of the first transmission element 1220 and is slidably connected to the manipulation assembly 2000 .

[0180] Specifically, the first sliding element 1230 is disposed at the proximal end section of the force applying member 1222 .

[0181] In some embodiments, the first sliding element 1230 is perpendicular to the force applying member 1222 .

[0182] In some embodiments, the first sliding element 1230 is detachably connected to the force applying member 1222 , including but not limited to plugging.

[0183] Under the control of the control assembly 2000, the first sliding element 1230 reciprocates between a first preset position and a second preset position. The first preset position corresponds to the knife-end position, and the second preset position corresponds to the knife-retracted position. When the first sliding element 1230 switches from the first preset position to the second preset position, the first transmission element 1220 moves from its distal end to its proximal end. When the first sliding element 1230 switches from the second preset position to the first preset position, the first transmission element 1220 moves from its distal end to its distal end.

[0184] In some embodiments, the first sliding element 1230 is a cylindrical pin.

[0185] As shown in Figures 6 and 7, the control assembly 2000 includes a housing unit 2100 and a blade control unit 2200. At least a portion of the cutting assembly 1000 is disposed within the housing unit 2100. The blade control unit 2200 is disposed within the housing unit 2100 and is pivotally connected to the transmission end of the cutting unit 1200. It is used to control the cutting unit 1200, causing the cutting unit 1200 to move relative to the sheath unit 1100 and switching the cutting unit 1200 between a retracted position and an upright position.

[0186] As shown in FIG8 , the housing unit 2100 includes a housing element 2110 , wherein at least a portion of the cutting assembly 1000 is disposed inside the housing element 2110 .

[0187] Specifically, at least a portion of the sheath tube unit 1100 and at least a portion of the cutting unit 1200 are disposed inside the housing element 2110 .

[0188] More specifically, at least a portion of the proximal end section of the sheath element 1110 , at least a portion of the first transmission element 1220 , and the first sliding element 1230 are disposed inside the housing element 2110 .

[0189] More specifically, at least a portion of the proximal end section of the second tube 1112 , at least a portion of the force applying member 1222 , and at least a portion of the channel member 1224 are disposed inside the housing element 2110 .

[0190] In some embodiments, the housing element 2110 includes a first housing member 2111 and a second housing member 2112 , wherein the second housing member 2112 is detachably connected to the first housing member 2111 .

[0191] The distal end of the first housing 2111 forms a first notch, and the distal end of the second housing 2112 forms a second notch. The second notch and the first notch together form a notch for the proximal end of the sheath element 1110 to be installed.

[0192] In some embodiments, the first housing member 2111 is an upper shell.

[0193] In some embodiments, the second housing member 2112 is a lower shell.

[0194] Furthermore, the housing unit 2100 further includes a first positioning element 2120 , wherein the first positioning element 2120 is provided on the housing unit 2110 and is located on the moving track of the knife control unit 2200 , so as to limit the moving range of the knife control unit 2200 .

[0195] Specifically, the first positioning element 2120 is disposed on the top of the first housing 2111 .

[0196] Generally, the first positioning element 2120 is disposed at the distal end of the first housing 2111 .

[0197] In some embodiments, the first positioning element 2120 includes a rotational positioning element 2121 and a movable positioning element 2122. The rotational positioning element 2121 is disposed at the distal end of the first housing 2111 and is used to limit the rotational range of the knife control unit 2200; the movable positioning element 2122 is disposed at the proximal end of the rotational positioning element 2121 and is in communication with the rotational positioning element 2121 and is used to limit the linear movement range of the knife control unit 2200.

[0198] As shown in Figures 9 to 11 , the blade control unit 2200 includes a rotating element 2210 and a blade control element 2220. The rotating element 2210 is disposed within the housing unit 2100; the blade control element 2220 is connected to the rotating element 2210 and pivotally connected to the transmission end of the cutting unit 1200, configured to rotate under the action of the rotating element 2210.

[0199] Specifically, the rotating element 2210 is disposed inside the housing element 2110 ; the knife-controlling element 2220 is disposed inside the housing element 2110 and is pivotally connected to the first transmission element 1220 .

[0200] More specifically, the rotating element 2210 is disposed between the first housing member 2111 and the second housing member 2112 ; the knife-controlling element 2220 is disposed between the first housing member 2111 and the second housing member 2112 and is pivotally connected to the force-applying member 1222 .

[0201] Generally, the rotating element 2210 reciprocates between the third preset position and the fourth preset position and rotates at the third preset position. Generally, the rotating element 2210 rotates at the third preset position to switch the cutting element 1210 between the knife-retracting position and the knife-standing position. When the cutting element 1210 switches from the knife-retracting position to the knife-standing position, the rotating element 2210 switches from the third preset position to the fourth preset position to enable the cutting element 1210 to cut. When the cutting element 1210 completes cutting, the rotating element 2210 switches from the fourth preset position to the third preset position and rotates at the third preset position to switch the cutting element 1210 from the knife-standing position to the knife-retracting position.

[0202] Generally, the rotation angle of the rotating element 2210 is 90°.

[0203] In some embodiments, the rotating element 2210 is a key pin.

[0204] Generally, the blade control element 2220 and the rotating element 2210 are not coaxially arranged, that is, the blade control element 2220 and the rotating element 2210 are eccentrically arranged.

[0205] Generally, the proximal end of the blade-controlling element 2220 is connected to the rotating element 2210, and the distal end of the blade-controlling element 2220 is pivotally connected to the proximal end of the first transmission element 1220. When the rotating element 2210 rotates, the blade-controlling element 2220 drives the proximal end of the first transmission element 1220 to rotate, thereby driving the cutting element 1210 to switch between the retracted and upright positions.

[0206] In some embodiments, the blade control element 2220 is disposed at the bottom end of the rotating element 2210 .

[0207] In some embodiments, the blade control element 2220 and the rotating element 2210 are detachably connected, including but not limited to plugging.

[0208] In some embodiments, the blade control element 2220 is a cam plate.

[0209] Furthermore, the blade control unit 2200 further includes a first actuating element 2230 , wherein the first actuating element 2230 is disposed at the top of the rotating element 2210 and is used to control the rotating element 2210 .

[0210] Specifically, the first actuating element 2230 is located outside the housing element 2110 .

[0211] More specifically, the first actuating element 2230 is located outside the first housing 2111 .

[0212] The first actuating element 2230 drives the rotating element 2210 to rotate at the third preset position, and drives the rotating element 2210 to reciprocate between the third preset position and the fourth preset position.

[0213] Generally, the first actuating element 2230 is located outside the housing element 2110. Specifically, the first actuating element 2230 is located outside the first housing element 2111.

[0214] In some embodiments, the first actuating element 2230 and the rotating element 2210 are detachably connected, including but not limited to plugging.

[0215] In addition, the first actuating element 2230 is positioned with the first positioning element 2120. Specifically, the first actuating element 2230 is rotationally positioned on the rotating positioning member 2121; and the first actuating element 2230 is movement positioned on the moving positioning member 2122.

[0216] In some embodiments, the first actuating element 2230 is a pull tab.

[0217] Furthermore, the knife control unit 2200 further includes a second sliding element 2240 , wherein the second sliding element 2240 is disposed on the knife control element 2220 , eccentrically disposed with respect to the rotating element 2210 , and slidably connected to the transmission end of the cutting unit 1200 .

[0218] Specifically, the second sliding element 2240 is slidably connected to the first sliding element 1230 .

[0219] When the knife-controlling element 2220 rotates along with the rotating element 2210 , the first sliding element 1230 remains relatively stationary, and the second sliding element 2240 slides with the first sliding element 1230 .

[0220] Generally, the second sliding element 2240 includes a first end and a second end. When the cutting element 1210 is in the retracted position, the first sliding element 1230 is located at the second end of the second sliding element 2240, and the first sliding element 1230 is located at the second preset position. When the cutting element 1210 is in the upright position, the first sliding element 1230 is located at the first end of the second sliding element 2240, and the first sliding element 1230 is located at the first preset position.

[0221] In some embodiments, the second sliding element 2240 is a sliding groove.

[0222] Furthermore, the knife control unit 2200 further includes a damping element 2250. The damping element 2250 is disposed at the connection position between the knife control element 2220 and the rotating element 2210 to increase damping.

[0223] The purpose of providing the damping element 2250 is to increase the damping of the rotating element 2210 during the rotation process.

[0224] In some embodiments, the damping element 2250 is a damping O-ring.

[0225] Furthermore, the knife control unit 2200 further includes a support element 2260. The support element 2260 is disposed inside the housing unit 2100 and is connected to the rotating element 2210 and the knife control element 2220 respectively.

[0226] Specifically, the support element 2260 is disposed inside the housing element 2110 , and is connected to the proximal end section of the first transmission element 1220 , and is slidably connected to the first sliding element 1230 .

[0227] More specifically, the support element 2260 is disposed between the first shell component 2111 and the second shell component 2112 , and is connected to the force applying member 1222 and the channel member 1224 .

[0228] Generally, the support element 2260 is slidably connected to the force applying member 1222. Specifically, when the force applying member 1222 moves, the support element 2260 remains relatively stationary, and the force applying member 1222 slides relative to the support element 2260.

[0229] Generally, the support element 2260 is engaged with the channel member 1224. Specifically, the support element 2260 and the channel member 1224 remain relatively stationary.

[0230] Generally, the support element 2260 is rotatably connected to the rotating element 2210. Specifically, when the rotating element 2210 rotates, the support element 2260 remains relatively stationary, and the rotating element 2210 rotates relative to the support element 2260.

[0231] Generally, the support element 2260 is rotatably connected to the knife control element 2220. Specifically, when the knife control element 2220 rotates, the support element 2260 remains relatively stationary, and the rotating element 2210 rotates relative to the support element 2260.

[0232] In some embodiments, the support member 2260 includes a first support member 2261 and a second support member 2262. The first support member 2261 is provided with a first engaging groove, a first sliding groove, a first rotation groove, and a second rotation groove in sequence from its distal end to its proximal end. The second support member 2262 is detachably connected to the first support member 2261. The second support member 2262 is provided with a second engaging groove, a second sliding groove, a third rotation groove, and a fourth rotation groove in sequence from its distal end to its proximal end. The second engaging groove forms a engaging groove with the first engaging groove and engages with the proximal end of the channel member 1224. The second sliding groove forms a sliding groove with the first sliding groove and is slidably connected to the first sliding member 1230. The third rotation groove forms a rotation groove with the first rotation groove and is rotationally connected to the rotation member 2210. The fourth rotation groove forms a rotation groove with the second rotation groove and is rotationally connected to the knife control member 2220.

[0233] The distal end of the sliding groove formed by the first sliding groove and the second sliding groove is the first preset position of the first sliding element 1230 , and the proximal end of the sliding groove formed by the first sliding groove and the second sliding groove is the second preset position of the first sliding element 1230 .

[0234] 1 and 2 , the soft tissue cutting device further includes a locking assembly 3000. The locking assembly 3000 is detachably mounted on the sheath unit 1100 of the cutting assembly 1000 to lock the depth of the sheath unit 1100 in the tissue.

[0235] As shown in Fig. 13, the locking assembly 3000 includes a locking unit 3100. The locking unit 3100 is detachably mounted on the sheath unit 1100 to lock the depth of the sheath unit 1100 in the tissue.

[0236] As shown in FIG12 , the locking unit 3100 includes a first locking element 3110 and a second locking element 3120 . The first locking element 3110 is removably disposed on the sheath unit 1100 ; the second locking element 3120 is removably disposed on the sheath unit 1100 and is detachably connected to the first locking element 3110 .

[0237] Specifically, the first locking element 3110 is removably disposed on the sheath element 1110 and is located on the scale element 1130 ; the second locking element 3120 is removably disposed on the sheath element 1110 and is located on the scale element 1130 .

[0238] More specifically, the first locking element 3110 is removably disposed on the second tube 1112 ; the second locking element 3120 is removably disposed on the second tube 1112 .

[0239] Generally, the detachable connection between the second locking element 3120 and the first locking element 3110 includes but is not limited to plugging.

[0240] In some embodiments, the first locking element 3110 is a locking sleeve.

[0241] In some embodiments, the second locking element 3120 is a locking core.

[0242] The method of use of the present invention is as follows:

[0243] (1) Positioning insertion depth

[0244] According to the cutting requirements, the first locking element 3110 and the second locking element 3120 are set at the designated positions of the scale element 1130; the sheath element 1110 is pushed deep into the position to be cut;

[0245] (2) The cutting element 1210 switches from the knife-retracting position to the knife-standing position

[0246] When the cutting element 1210 is in the knife-retracting position, the first sliding element 1230 is located at the second preset position, and the rotating element 2210 is located at the third preset position; the first actuating element 2230 is manipulated to rotate the first actuating element 2230 on the rotating positioning member 2121, so that the rotating element 2210 rotates; during the rotation of the rotating element 2210, the knife-controlling element 2220 rotates along with the rotation of the rotating element 2210; during the rotation of the knife-controlling element 2220, the first sliding element 1230 cooperates with the second sliding element 2240, so that the first sliding element 1230 moves from the second preset position to the first preset position; During the movement of the sliding element 1230 from the second preset position to the first preset position, the force-applying member 1222 moves from its distal end to its proximal end, causing the intermediate member 1221 to rotate clockwise about the pivotal connection between the intermediate member 1221 and the force-applying member 1222, thereby causing the cutting element 1210 to rotate counterclockwise about the pivotal connection between the cutting element 1210 and the channel member 1224. When the first actuating member 2230 rotates to the linearly movable position, the first actuating member 2230 is stopped. At this time, the rotating member 2210 and the knife-controlling member 2220 stop rotating, and the first sliding member 1230 is in the first preset position.

[0247] (3) Cutting element 1210 cutting

[0248] When the cutting element 1210 is in the vertical knife position, the first sliding element 1230 is in the first preset position, and the rotating element 2210 is in the third preset position. The first actuating element 2230 is manipulated to linearly move along the movable positioning member 2122 from the third preset position to the fourth preset position, so that the rotating element 2210 is linearly moved. During the linear movement of the rotating element 2210, the knife control element 2220 and the support element 2260 move linearly along with the linear movement of the rotating element 2210. The channel member 1224 cooperates with the support element 2260 to drive the cutting element 1210 to perform cutting. When the first actuating element 2230 moves to the fourth preset position, the manipulation of the first actuating element 2230 is stopped. At this time, the rotating element 2210 and the knife control element 2220 stop moving, the first sliding element 1230 is in the first preset position, and the rotating element 2210 is in the fourth preset position. At this time, the cutting element 1210 completes the cutting.

[0249] (4) Reset

[0250] During the resetting process, the cutting element 1210 is in the vertical knife position, the first sliding element 1230 is in the first preset position, and the rotating element 2210 is in the fourth preset position; the first actuating element 2230 is manipulated to make the first actuating element 2230 move linearly along the movable positioning member 2122 from the fourth preset position to the third preset position, so that the rotating element 2210 moves linearly; during the linear movement of the rotating element 2210, the knife control element 2220 and the support element 2260 move linearly with the linear movement of the rotating element 2210. The cutting element 1210 is driven to reset by the cooperation of the channel member 1224 and the support member 2260; when the first actuating member 2230 moves to the third preset position, the first actuating member 2230 is stopped from being manipulated. At this time, the rotating member 2210 and the knife control member 2220 stop moving. The first sliding member 1230 is located at the first preset position, and the rotating member 2210 is located at the third preset position; the first actuating member 2230 is manipulated to rotate the first actuating member 2230 on the rotating positioning member 2121. , so that the rotating element 2210 rotates; during the rotation of the rotating element 2210, the knife control element 2220 rotates along with the rotation of the rotating element 2210; during the rotation of the knife control element 2220, the first sliding element 1230 cooperates with the second sliding element 2240, so that the first sliding element 1230 moves from the first preset position to the second preset position; during the movement of the first sliding element 1230 from the first preset position to the second preset position, the force applying member 1222 moves from its proximal end section to its distal end section, so that the intermediate member 1 221 rotates counterclockwise about the pivotal connection between the intermediate member 1221 and the force-applying member 1222, thereby causing the cutting element 1210 to rotate clockwise about the pivotal connection between the cutting element 1210 and the intermediate member 1221. When the first actuating member 2230 rotates to a position where linear movement is impossible, the first actuating member 2230 is stopped. At this time, the rotating member 2210 and the knife-controlling member 2220 stop rotating, the first sliding member 1230 is in the second preset position, and the cutting member 1210 is in the knife-retracted position.

[0251] (5) Removal;

[0252] The sheath element 1110 is moved out of the cutting site.

[0253] The technical effects of the present invention are as follows:

[0254] 1) The coordination of the control component and the cutting component simplifies the cutting operation, controls the cutting size, reduces the number of cuts, and improves surgical efficiency;

[0255] 2) The cutting unit adopts guide rail technology. After the sheath unit is positioned, the cutting unit can move axially within the sheath unit to cut, ensuring cutting stability and safety, avoiding the traditional cutting method without guide rails or the entire sheath moving, and realizing linear cutting;

[0256] 3) The cutting end of the cutting unit is controllable in length, allowing it to cut soft tissues of varying thicknesses;

[0257] 4) The control component enables single-handed operation without the need for the other hand or an assistant, saving labor costs and facilitating outpatient surgery.

[0258] 5) The cutting depth can be effectively positioned by utilizing the cooperation between the locking component and the cutting component.

[0259] Example 2

[0260] This embodiment is a variation of embodiment 1.

[0261] As shown in Figures 13 and 14, a soft tissue cutting device includes a cutting assembly 1000, a control assembly 2000, and a locking assembly 3000. The control assembly 2000 is connected to the cutting assembly 1000 and is used to control the cutting assembly 1000 to switch between a retracted position and an upright position. The locking assembly 3000 is detachably mounted on the distal end of the cutting assembly 1000 and is used to lock the depth of the cutting assembly 1000 into the tissue.

[0262] As shown in FIG15 , the cutting assembly 1000 further includes a balloon unit 1300. The balloon end of the balloon unit 1300 is disposed at the distal end of the sheath unit 1100 and is connected to the manipulation assembly 2000. The balloon end of the balloon unit 1300 is configured to be inflated to a predetermined state under the manipulation of the manipulation assembly 2000, or to be restored to an initial state under the manipulation of the manipulation assembly 2000.

[0263] As shown in Figure 16, the balloon unit 1300 includes a balloon component 1310 and at least one fluid delivery component 1320. The balloon component 1310 is disposed at the distal end of the sheath unit 1100; the distal end of the fluid delivery component 1320 is in communication with the balloon component 1310, and the proximal end of the fluid delivery component 1320 is in communication with the manipulation component 2000, for delivering a working medium to the balloon component 1310 under the control of the manipulation component 2000 to fill the balloon component 1310 to a predetermined state, or delivering a working medium to the manipulation component 2000 under the control of the manipulation component 2000 to restore the balloon component 1310 to its initial state.

[0264] Specifically, the balloon component 1310 is located at the distal end of the sheath component 1110 and at least on one side of the distal end of the sheath component 1110 ; the fluid delivery component 1320 is located inside the sheath component 1110 .

[0265] Generally, the opening member 1120 includes a first opening member and at least one second opening member. The first opening member is provided at the upper portion of the distal end of the first tubular member 1111 for allowing the cutting member 1210 to pass through; the second opening member is provided at the side of the distal end of the first tubular member 1111 for allowing the balloon member 1310 to pass through.

[0266] In some embodiments, there are two second opening pieces, and the two second opening pieces are symmetrically arranged on both sides of the first opening piece.

[0267] In some embodiments, the balloon member 1310 includes a first balloon member 1311 and a second balloon member 1312. The first balloon member 1311 is disposed on the first tube member 1111, located on one side of the channel member 1224, and communicates with the fluid transport member 1320; the second balloon member 1312 is disposed on the first tube member 1111, located on the other side of the channel member 1224, and communicates with the fluid transport member 1320.

[0268] When the first balloon member 1311 is inflated to a predetermined state, the first balloon member 1311 protrudes from a second opening member.

[0269] When the second balloon member 1312 is inflated to a predetermined state, the second balloon member 1312 protrudes from the other second opening member.

[0270] The second balloon member 1312 may or may not be in communication with the first balloon member 1311. Preferably, the distal end of the second balloon member 1312 is in communication with the distal end of the first balloon member 1311.

[0271] In some embodiments, there is one fluid delivery element 1320 , which is in communication with both the first balloon component 1311 and the second balloon component 1312 , and delivers the working medium to both the first balloon component 1311 and the second balloon component 1312 .

[0272] In some embodiments, there are two fluid transport elements 1320 , one fluid transport element 1320 communicating with the first balloon component 1311 , and the other fluid transport element 1320 communicating with the second balloon component 1312 .

[0273] In some embodiments, the fluid delivery element 1320 is a fluid delivery channel or a fluid delivery tube (the entire length is not shown in the figure, only a portion of the length is shown).

[0274] As shown in Figures 17 and 18, the manipulation assembly 2000 further includes a fluid delivery unit 2300. The fluid delivery unit 2300 is in communication with the balloon unit 1300 of the cutting assembly 1000 and is configured to deliver a working medium to the balloon unit 1300 to fill the balloon unit 1300 to a predetermined state, or to retrieve the working medium delivered by the balloon unit 1300 to restore the balloon unit 1300 to its initial state.

[0275] As shown in Figure 19, the housing unit 2100 further includes a second positioning element 2130. The second positioning element 2130 is provided in the housing unit 2100 and is detachably connected to the actuating end of the fluid delivery unit 2300 to limit the state of the fluid delivery unit 2300.

[0276] Specifically, the second positioning element 2130 is disposed on a side of the housing element 2110 .

[0277] More specifically, the second positioning element 2130 is at least disposed on a side of the first housing 2111 .

[0278] The second positioning element 2130 provided on the side of the first housing 2111 is used to accommodate and lock the actuating end of the fluid delivery unit 2300 .

[0279] Furthermore, a third notch is formed on the side of the proximal section of the first shell member 2111, and a fourth notch is formed on the side of the proximal section of the second shell member 2112. The fourth notch and the third notch together form a notch for the actuating end of the fluid delivery unit 2300 to move.

[0280] Furthermore, the proximal section of the first shell 2111 forms a fifth notch, and the proximal section of the second shell 2112 forms a sixth notch. The sixth notch and the fifth notch together form a notch for installation of the input end of the fluid delivery unit 2300.

[0281] As shown in Figures 20 and 21, the fluid delivery unit 2300 includes a storage element 2310, a second transmission element 2320, and a second actuating element 2330. The storage element 2310 is in communication with the balloon unit 1300 and is used to deliver a working medium to the balloon unit 1300 or to obtain the working medium delivered by the balloon unit 1300; the second transmission element 2320 is connected to the storage element 2310; and the second actuating element 2330 is connected to the second transmission element 2320 and is used to actuate the second transmission element 2320 to cause the storage element 2310 to deliver a working medium to the balloon unit 1300, or to cause the balloon unit 1300 to deliver a working medium to the storage element 2310.

[0282] Specifically, the storage element 2310 is arranged inside the proximal section of the shell element 2110 and is connected to the fluid delivery element 1320, and is used to deliver the working medium to the balloon element 1310 through the fluid delivery element 1320; the second transmission element 2320 is arranged inside the proximal section of the shell element 2110; at least a portion of the second actuating element 2330 is arranged inside the proximal section of the shell element 2110, and at least a portion of the second actuating element 2330 is arranged outside the proximal section of the shell element 2110.

[0283] In some embodiments, the storage element 2310 includes an injection container 2311, an input interface 2312, an output interface 2313, a pusher 2314, and a piston 2315. The injection container 2311 is fixedly disposed between the first housing 2111 and the second housing 2112, and is in communication with the fluid delivery element 1320; the input interface 2312 is disposed in the injection container 2311, and is in communication with the interior of the injection container 2311, and is in communication with the working medium supply device, for supplying the working medium to the injection container 2311; the output interface 2313 is disposed in the injection container 2311, and is in communication with the interior of the injection container 2311, and is in communication with the fluid delivery element 1320, for supplying the working medium to the injection container 2311. The working medium of 2311 is transported to the fluid transport element 1320; the pushing member 2314 is movably connected to the injection container member 2311 and is pivotally connected to the second transmission element 2320, and is used to suck the working medium from the outside to the injection container member 2311 and push the working medium out of the injection container member 2311 under the action of the second transmission element 2320; the piston member 2315 is arranged at the distal end of the pushing member 2314, and is used to improve the sealing between the pushing member 2314 and the injection container member 2311 and increase the damping during the movement of the pushing member 2314.

[0284] In some embodiments, the input interface component 2312 is disposed at the distal end of the injection container component 2311 .

[0285] In some embodiments, the output interface component 2313 is disposed at the distal end of the injection container component 2311 .

[0286] The number of output interface components 2313 matches the number of fluid delivery components 1320. Generally, the number of output interface components 2313 is equal to the number of fluid delivery components 1320.

[0287] Under the action of the second actuating element 2330, the pushing member 2314 reciprocates between the fifth and sixth preset positions. When the pushing member 2314 switches from the fifth to the sixth preset position, the working medium is input from the input interface 2312 into the interior of the injection container 2311. When the pushing member 2314 switches from the sixth to the fifth preset position, the working medium flows out from the output interface 2313 to the fluid delivery element 1320.

[0288] One end of the second transmission element 2320 is pivotally connected to the proximal end of the pushing member 2314 , and the other end of the second transmission element 2320 is pivotally connected to the second actuating element 2330 .

[0289] In some embodiments, the second transmission element 2320 is a T-bar.

[0290] Generally, the second actuating element 2330 is movably disposed in the gap formed by the third gap and the fourth gap.

[0291] The second actuating element 2330 is pivotally connected to the housing element 2110 and the second transmission element 2320. Specifically, the second actuating element 2330 rotates about its pivotal connection with the housing element 2110, thereby driving the second transmission element 2320 to rotate, and further driving the pusher 2314 to reciprocate along the axial direction of the injection container 2311.

[0292] Generally, the second actuating element 2330 reciprocates between the seventh preset position and the eighth preset position. When the second actuating element 2330 switches from the seventh preset position to the eighth preset position, the pushing member 2314 switches from the fifth preset position to the sixth switching position; and when the second actuating element 2330 switches from the eighth preset position to the seventh preset position, the pushing member 2314 switches from the sixth preset position to the fifth switching position.

[0293] In some embodiments, the second actuating element 2330 is a pressure handle.

[0294] Furthermore, the fluid delivery unit 2300 further includes a third positioning element 2340 , which is disposed at the end of the second actuating element 2330 and detachably connected to the housing unit 2100 , for limiting the state of the second actuating element 2330 .

[0295] Specifically, the third positioning element 2340 is disposed at the end of the second actuating element 2330 located outside the housing element 2110 and is detachably connected to the second positioning element 2130 .

[0296] Generally, the detachable connection between the third positioning element 2340 and the second positioning element 2130 includes but is not limited to plugging.

[0297] When the third positioning element 2340 is connected to the second positioning element 2130 , the second actuating element 2330 is located at the seventh preset position.

[0298] In some embodiments, the third positioning element 2340 and the second actuating element 2330 are bendable. Specifically, when the third positioning element 2340 is connected to the second positioning element 2130, pressing the third positioning element 2340 can separate the third positioning element 2340 from the second positioning element 2130, thereby allowing the second actuating element 2330 to be manipulated.

[0299] In some embodiments, the third positioning element 2340 is a pressing handle.

[0300] Furthermore, the fluid transport unit 2300 further includes an elastic element 2350 , wherein the elastic element 2350 is disposed between the storage element 2310 and the second transmission element 2320 .

[0301] Specifically, the elastic element 2350 is disposed between the injection container 2311 and the pushing member 2314 .

[0302] When the pushing member 2314 is located at the fifth preset position, the elastic element 2350 is in a compressed state; when the pushing member 2314 is located at the sixth preset position, the elastic element 2350 is in an extended state.

[0303] In some embodiments, the elastic element 2350 is a compression spring.

[0304] Furthermore, the fluid delivery unit 2300 further includes a valve element 2360. The valve element 2360 is in communication with the storage element 2310 for allowing the working medium to flow in one direction.

[0305] Specifically, the valve component 2360 is disposed at the proximal end of the housing component 2110 .

[0306] More specifically, valve element 2360 is in communication with input interface member 2312 .

[0307] Generally, the valve element 2360 is disposed in the gap formed by the fifth gap and the sixth gap.

[0308] In some of these embodiments, valve element 2360 is a one-way valve.

[0309] The method of using this embodiment is as follows:

[0310] (1) Inputting the working medium into the storage element 2310

[0311] The second actuating element 2330 is in the seventh preset position, and the pushing member 2314 is in the fifth preset position;

[0312] Press the third positioning element 2340 to unlock the third positioning element 2340 from the second positioning element 2130;

[0313] The second actuating element 2330 is manipulated to rotate about the pivotal connection between the second actuating element 2330 and the housing element 2110 , and the second actuating element 2330 is switched from the seventh preset position to the eighth preset position;

[0314] During the rotation of the second actuating element 2330 , the second transmission element 2320 drives the pushing member 2314 to move linearly, and the pushing member 2314 switches from the fifth preset position to the sixth preset position.

[0315] During the linear movement of the push member 2314 , the working medium enters the interior of the injection container member 2311 through the valve element 2360 and the input interface member 2312 ;

[0316] When the second actuating element 2330 is located at the eighth preset position and the pushing member 2314 is located at the sixth preset position, the working medium in the injection container 2311 reaches a preset volume;

[0317] (2) Filling balloon element 1310

[0318] The second actuating element 2330 is manipulated to rotate about the pivotal connection between the second actuating element 2330 and the housing element 2110 , and the second actuating element 2330 is switched from the eighth preset position to the seventh preset position;

[0319] During the rotation of the second actuating element 2330 , the second transmission element 2320 drives the pushing member 2314 to move linearly, and the pushing member 2314 switches from the sixth preset position to the fifth preset position.

[0320] During the linear movement of the pusher 2314 , the working medium enters the first balloon member 1311 and the second balloon member 1312 through the output interface member 2313 and the fluid delivery element 1320 ;

[0321] When the second actuating element 2330 is located at the seventh preset position and the pushing element 2314 is at the fifth preset position, the first balloon element 1311 and the second balloon element 1312 are inflated to a predetermined state, and the third positioning element 2340 is connected to the second positioning element 2130;

[0322] The cutting element 1210 can then be manipulated to cut;

[0323] (3) Balloon element 1310 discharges working medium

[0324] When the cutting element 1210 completes cutting, the second actuating element 2330 is in the seventh preset position, and the pushing member 2314 is in the fifth preset position;

[0325] Press the third positioning element 2340 to unlock the third positioning element 2340 from the second positioning element 2130;

[0326] The second actuating element 2330 is manipulated to rotate about the pivotal connection between the second actuating element 2330 and the housing element 2110 , and the second actuating element 2330 is switched from the seventh preset position to the eighth preset position;

[0327] During the rotation of the second actuating element 2330 , the second transmission element 2320 drives the pushing member 2314 to move linearly, and the pushing member 2314 switches from the fifth preset position to the sixth preset position.

[0328] During the linear movement of the pusher 2314 , the working medium of the first balloon 1311 and the second balloon 1312 enters the interior of the injection container 2311 through the fluid delivery element 1320 and the output interface 2313 ;

[0329] When the second actuating element 2330 is located at the eighth preset position and the pushing member 2314 is located at the sixth preset position, the first balloon member 1311 and the second balloon member 1312 return to their initial states.

[0330] The technical effects of this embodiment are as follows:

[0331] 1) By combining the balloon unit and the fluid delivery unit, the cutting space at the location to be cut can be expanded to expose the tissue to be cut, thereby preventing damage to other tissues during the cutting process;

[0332] 2) When the balloon unit is not expanded, the diameter of the sheath unit will not increase, which can ensure a smaller incision; when the balloon unit is expanded, the nerves near the sheath unit can be stretched to increase safety, the pressure in the soft tissue cavity can be increased, and the cutting efficiency can be improved; after the pressure in the soft tissue cavity is increased, the cutting end of the cutting unit can be stabilized to prevent the cutting end from rotating.

[0333] Example 3

[0334] This embodiment relates to the soft tissue cutting device of the present invention.

[0335] Figure 22 shows a soft tissue cutting device, which includes a cutting body 1 and a control component 2, and the cutting body 1 is connected to the control component 2. As shown in Figures 22-24, the cutting body 1 includes a cutting component 11 and an outer sheath 12 with an opening 121. At least a portion of the structure of the cutting component 11 is located in the outer sheath 12. The cutting component 11 can move relative to the outer sheath 12 under the control of the control component 2, so that the cutting member 1111 of the cutting component 11 can move longitudinally in the opening 121, thereby cutting the tissue. The opening 121 is located at the distal end of the outer sheath 12, and its longitudinal dimension can limit the range of movement of the cutting member 1111, as shown in Figure 22. The outer sheath 12 extends longitudinally and has a size and cross-sectional shape suitable for insertion into the target tissue area. The distal end face of the outer sheath 12 is preferably an arc-shaped structure to reduce damage to the tissue when guiding the outer sheath 12 to move in the tissue. The distal end of the outer sheath 12 can have any other desired configuration. In some embodiments, the distal end of the outer sheath 12 includes an ultrasound probe to locate the position of the outer sheath 12 in the tissue. Preferably, the outer sheath 12 is coated with a hydrophilic coating to make the surface smoother and facilitate the insertion of the front end into the tissue.

[0336] As shown in Figures 23-25, the cutting assembly 11 includes a cutting unit 111 and an auxiliary unit 112. The cutting unit 111 includes a cutting member 1111 and a transmission member 1112. The cutting member 1111 is pivotally connected to the distal end of the transmission member 1112, and the transmission member 1112 can move relative to the auxiliary unit 112. The cutting member 1111 is pivotally connected to the auxiliary unit 112. The proximal end of the transmission member 1112 is connected to the control assembly 2. The control assembly 2 controls the transmission member 1112 to cause the cutting member 1111 to pivot relative to the auxiliary unit 112, so that the cutting member 1111 protrudes outward from the opening 121 to a vertical position for cutting tissue or switches from the vertical position to a retracted position; in the retracted position, the cutting member 1111 is accommodated in the internal space of the outer sheath 12. Under the control of the control assembly 2, the auxiliary unit 112 can move relative to the outer sheath 12 to cut tissue.

[0337] Furthermore, the transmission member 1112 includes an intermediate member 11121 and a force member 11122, and the intermediate member 11121 is pivotally connected to the force member 11122 and the cutting member 1111, respectively. In this embodiment, when the cutting member 1111 needs to be switched to the vertical knife position, the control assembly 2 applies a thrust to the force member 11122 to push the intermediate member 11121 toward the distal end of the device. The intermediate member 11121 then pushes the cutting member 1111 to pivot relative to the auxiliary unit 112. As the cutting member 1111 moves toward the vertical knife position, the intermediate member 11121 pivots relative to the force member 11122 and the cutting member 1111. When the cutting member 1111 reaches the vertical knife position, the intermediate member 11121 cooperates with the force member 11122 to support the cutting member 1111. When the cutting member 1111 needs to be switched to the knife-retracting position, the control assembly 2 applies a pulling force to the force-applying member 11122 to pull the intermediate member 11121 toward the proximal end of the device. The intermediate member 11121 then pulls the cutting member 1111 to pivot relative to the auxiliary unit 112. As the cutting member 1111 moves toward the knife-retracting position, the intermediate member 11121 pivots relative to the force-applying member 11122 and the cutting member 1111 until the cutting member 1111 reaches the knife-retracting position. In other embodiments, the control assembly 2 may also apply a pulling force to the force-applying member 11122 to pull the intermediate member 11121 toward the proximal end of the device. The intermediate member 11121 then pulls the cutting member 1111 to pivot relative to the auxiliary unit 112, thereby switching the cutting member 1111 to the knife-standing position. When the cutting member 1111 needs to be switched to the knife-retracting position, a thrust is applied to the force-applying member 11122. Alternatively, the middle piece 11121 can be integrally formed with the force-applying piece 11122. Preferably, the middle piece 11121 can be set at an angle to the force-applying piece 11122. When the cutting piece 1111 switches between the upright position and the retracted position, it is only necessary to ensure that the force required for the cutting piece 1111 to pivot relative to the auxiliary unit 112 is not greater than the resistance encountered by the auxiliary unit 112 when sliding relative to the outer sheath 12. The initial retracted position of the cutting piece 1111 can be located on the proximal side of the opening 121 or on the distal side of the opening 121; in this embodiment, the initial retracted position of the cutting piece 1111 is located on the distal side of the opening 121.

[0338] Furthermore, the transmission member 1112 includes an accommodating space 11123 for accommodating at least a portion of the cutting member 1111. As shown in Figures 24 and 25, when the cutting member 1111 is in the retracted position, the accommodating space 11123 accommodates at least a portion of the cutting member 1111, thereby preventing the cutting member 1111 from protruding outside the outer sheath 12 and thus preventing the outer sheath 12 from damaging the tissue when inserted into the tissue. Preferably, the accommodating space 11123 is provided on the intermediate member 11121. Preferably, the cutting edge of the cutting member 1111 can be accommodated in the accommodating space 11123.

[0339] Furthermore, the auxiliary unit 112 may include a limiting member 1121, which cooperates with the transmission member 1112 and the control assembly 2 to maintain the cutting member 1111 in the upright position. In this embodiment, the limiting member 1121 is located at the distal end of the auxiliary unit 112. As shown in Figure 25, the cutting member 1111 is positioned between the limiting member 1121 and the transmission member 1112. Furthermore, the auxiliary unit 112 may include a sheath structure; alternatively, it may include a profile with a U-shaped cross-section. The structure of the auxiliary unit 112 is not limited to this, as long as it meets its functional requirements.

[0340] The cutting body 1 also includes a balloon assembly 13, as shown in Figures 22 and 26. The balloon assembly 13 includes at least one balloon 131, preferably two balloons 131 with longitudinal dimensions. The balloons 131 are disposed at the distal end of the cutting body 1, on either side of the opening 121, preferably located below or at the bottom of the opening 121, and aligned with the axial position of the opening 121. During tissue cutting, the balloons 131 can separate the tissue to be cut from other nearby tissues, effectively increasing the safe zone for cutting, ensuring that only the tissue to be cut is cut while preventing cutting of other nearby tissues. The balloons 131 can also increase the stability of the cutting body 1 within the tissue. When filled with a working medium, the balloons 131 can expand radially outward from the outer sheath 12, as shown in Figure 236. The cross-section of the balloon 131 when filled can have a spherical, elliptical, fan-shaped, or other shape. When the working medium is expelled from the balloons 131, the balloons 131 contract radially and can be retracted into the outer sheath 12, as shown in Figure 22. Preferably, the longitudinal dimension of the balloon 131 matches the travel of the cutting member 1111 within the opening 121 .

[0341] The balloon assembly 13 further includes fluid conduits 132 located in the outer sheath 12 and having a number matching that of the balloon 131 , so as to deliver or discharge a working medium to or from the balloon 131 , as shown in FIG. 26 .

[0342] As shown in FIG23 , the control assembly 2 includes a knife control unit 24, which is connected to the transmission member 1112 and can control the transmission member 1112 to cause the cutting member 1111 to pivot relative to the auxiliary unit 112. In this embodiment, the knife control unit 24 includes a rotating shaft 241 and a slide 242. The slide 242 has an arcuate surface that is eccentrically disposed relative to the rotating shaft 241. A sliding member 11124 that cooperates with the arcuate surface is disposed at the proximal end of the transmission member 1112. By rotating the knife control unit 24, the sliding member 11124 slides along the arcuate surface to control the transmission member 1112, causing the cutting member 1111 to pivot relative to the auxiliary unit 112, thereby switching between the knife-retracting position and the knife-standing position. When the cutting member 1111 is in the knife-retracting position, there is a first distance between the sliding member 11124 and the rotating shaft 241; when the cutting member 1111 is in the knife-standing position, there is a second distance between the sliding member 11124 and the rotating shaft 241, and the first distance is different from the second distance. Preferably, the slide 242 is provided with a retaining structure to retain the sliding member 11124 in the corresponding position of the slide 242 when the cutting member 1111 is in the knife-retracting position and the knife-standing position, respectively, to prevent the cutting member 1111 from shifting. The slide 242 may include a through hole, the arcuate surface being part of the side wall of the through hole, and the sliding member 11124 may be arranged to pass through the through hole. Alternatively, since the functions are mutual, the chute 242 and the sliding member 11124 can also be arranged in the opposite direction, that is, the chute 242 is arranged on the transmission member 1112, and the sliding member 11124 is arranged on the knife control unit 24, so as to realize the switching of the cutting member 1111 between the knife-retracted position and the knife-up position. In another embodiment, a gear tooth structure can be provided on the knife control unit 24, and a rack can be provided at the proximal end of the transmission member 1112. The tooth structure and the rack can replace the cooperation between the chute 242 and the sliding member 11124, and the switching of the cutting member 1111 between the knife-retracted position and the knife-up position can be realized by rotating the knife control unit 24.

[0343] Alternatively, the knife control unit 24 is connected to the transmission member 1112, and can directly push and pull the knife control unit 24 to switch the cutting member 1111 between the knife-retracted position and the knife-standing position. For example, in the initial state, the cutting member 1111 is close to the proximal end of the opening 121 and is in the knife-retracted position. When the knife control unit 24 is pushed, the knife control unit 24 directly pushes the transmission member 1112, thereby causing the cutting member 1111 to pivot relative to the auxiliary unit 112, thereby switching the cutting member 1111 from the knife-retracted position to the knife-standing position, and continuing to push the knife control unit 24 to cut the tissue; when the cutting member 1111 has cut the tissue and needs to be retracted into the internal space of the outer sheath 12, the knife control unit 24 is pulled back, and the knife control unit 24 directly pulls the transmission member 1112, thereby causing the cutting member 1111 to pivot relative to the auxiliary unit 112, thereby switching the cutting member 1111 from the knife-standing position to the knife-retracted position.

[0344] As shown in Figures 22 and 23, the manipulation assembly 2 further includes an actuating unit 23 and a housing 25. The actuating unit 23 can move relative to the housing 25 to cause the cutting element 1111 to cut the target tissue in the cutting direction. In some embodiments, the actuating unit 23 can be combined with the knife control unit 24 into a single component. As mentioned above, a soft tissue cutting device that directly pushes and pulls the knife control unit 24 to switch the cutting element 1111 between the retracted position and the upright position integrates the actuating unit 23 and the knife control unit 24 into a single component. In this embodiment, the actuating unit 23 can move in the cutting direction relative to the shell 25 so that the cutting member 1111 cuts the target tissue; the actuating unit 23 includes a control member 231 and a connecting member 232. As shown in Figures 26 and 27, the control member 231 is connected to the knife control unit 24 through the connecting member 232. The rotating shaft 241 of the knife control unit 24 is pivotally connected to the connecting member 232. When the cutting member 1111 switches between the knife retracting position and the knife standing position, the rotating shaft 241 and the connecting member 232 rotate relative to each other, thereby driving the transmission member 1112 to move relative to the connecting member 232.

[0345] In this embodiment, the proximal end section of the auxiliary unit 112 is connected to the connecting member 232, thereby providing the resistance to the sliding of the auxiliary unit 112 relative to the outer sheath 12 required for the cutting member 1111 to pivot relative to the auxiliary unit 112, as shown in Figure 27. In other embodiments, the proximal end section of the auxiliary unit 112 and the connecting member 232 may not be connected. Based on this, a structure that increases the friction between the auxiliary unit 112 and the outer sheath 12, such as a concave-convex structure, a friction washer, etc., can be provided between the auxiliary unit 112 and the outer sheath 12 to provide the above-mentioned resistance.

[0346] When the cutting member 1111 is in the upright position and begins to cut tissue, the operating member 231 can be pushed or pulled to cause the connecting member 232 to move in the cutting direction relative to the housing 25. Driven by the connecting member 232, the knife control unit 24 also moves accordingly, because it remains relatively stationary with the connecting member 232 in the cutting direction, allowing the cutting member 1111 to cut tissue in the cutting direction. Furthermore, a guide member, such as a slide rail, is provided within the housing 25 to guide the movement of the connecting member 232 in the cutting direction.

[0347] Alternatively, the operating member 231 may also be directly set on the knife control unit 24. When the rotation of the knife control unit 24 drives the cutting member 1111 to reach the target position, the operating member 231 on the knife control unit 24 can be further operated to push and pull the knife control unit 24, thereby pushing and pulling the transmission member 1112; based on this, the knife control unit 24 can be set on the shell 25 in a rotatable and translational manner. If tissue cutting is required, the knife control unit 24 can be rotated first to make the cutting member 1111 in the upright knife position, and then push and / or pull the knife control unit 24 to cut the tissue.

[0348] The aforementioned retaining structure may alternatively or additionally include a first positioning assembly 233 of the actuating unit 23 and a first positioning notch 243 of the blade control unit 24. As shown in Figures 26 and 27, there may be multiple first positioning notches 243, such as two or three, to cooperate with the first positioning assembly 233 to maintain its position when the blade control unit 24 rotates to different target angles, thereby controlling the cutting angle of the cutting member 1111 and preventing displacement of the cutting member 1111. If the blade control unit 24 needs to disengage from the first positioning notch 243 to continue rotating, the force applied to the blade control unit 24 can cause the first positioning assembly 233 to deflect and disengage from the first positioning notch 243. The first positioning component 233 can be an elastic cylinder, an elastic component, etc. Preferably, the part of the first positioning component 233 that cooperates with the first positioning port 243 is a ball head, which can be connected to the elastic member. When the knife control unit 24 rotates to the target angle, the ball head of the first positioning component 233 falls into the first positioning port 243. When the knife control unit 24 needs to continue to rotate, the force applied to the knife control unit 24 causes the first positioning component 233 to deflect out of the first positioning port 243. Furthermore, the first positioning port 243 can be a through hole located in the middle part of the knife control unit 24, or it can be a side opening provided at the edge of the knife control unit 24. The first positioning component 233 is provided on the connecting member 232. Alternatively, the first positioning port 243 and the first positioning component 233 can be interchanged, and the function of the retaining structure can also be achieved, which will not be elaborated here.

[0349] Furthermore, the control assembly 2 also includes a second positioning assembly 28 to maintain the position of the knife control unit 24 in the cutting direction, as shown in Figures 23, 26-28. The second positioning assembly 28 includes an actuator 281 and a first limiting member 283, and the actuator 281 is connected to the first limiting member 283. The control assembly 2 includes a second positioning port 26, as shown in Figure 26. There can be multiple second positioning ports 26, which are preferably provided on the housing 25 and located on the moving trajectory of the control member 231. The knife control unit 24 can be positioned to different target positions through the cooperation of the second positioning port 26 and the first limiting member 283. When the knife control unit 24 is in the target position, the second positioning port 26 limits the movement of the first limiting member 283; when the knife control unit 24 needs to be separated from the target position, the first limiting member 283 is separated from the second positioning port 26 by operating the actuator 281.

[0350] The second positioning assembly 28 further includes a first elastic member 282, which is disposed between the actuator 281 and the first stopper 283. When the blade control unit 24 is in the target position, and in the absence of external force, the first elastic member 282 engages the second positioning opening 26 with the first stopper 283, thereby limiting the movement of the blade control unit 24, as shown in Figures 26 and 28a. When the blade control unit 24 needs to move away from the target position, in this embodiment, the actuator 281 is manipulated to compress the first elastic member 282, thereby disengaging the first stopper 283 from the second positioning opening 26, as shown in Figure 238b. Furthermore, the second positioning component 28 is arranged on the operating member 231. The second positioning component 28 passes through the operating member 231 to separate the first limiting member 283 and the actuator 281 on both sides of the operating member 231. The two ends of the first elastic member 282 are supported by the operating member 231 and the actuator 281 respectively. When the knife control unit 24 needs to be separated from the target position, the actuator 281 can be pressed with a finger, and the operating member 231 can be operated by the finger to separate the knife control unit 24 from the target position.

[0351] As shown in Figures 22, 26, and 29, the control assembly 2 also includes a fluid delivery mechanism 21. The fluid delivery mechanism 21 can deliver working medium to the balloon 131 through a fluid conduit 132 to inflate the balloon 131, and can also discharge working medium from the balloon 131 to deflate the balloon 131. The fluid delivery mechanism 21 includes a brake unit 211, a transmission unit 212, and a storage unit 213. As shown in Figures 26 and 29, the brake unit 211 is pivotally connected to the housing 25. The pivotal movement of the brake unit 211 activates the transmission unit 212 to discharge or draw working medium from the storage unit 213. When the brake unit 211 rotates toward the housing 25, it activates the transmission unit 212 to deliver the working medium in the storage unit 213 to the balloon 131, as shown in Figure 26. When the brake unit 211 rotates away from the housing 25 , the brake unit 211 actuates the transmission unit 212 to transport the working medium in the balloon 131 to the storage unit 213 , as shown in FIGS. 22 and 29 .

[0352] The transmission unit 212 can be a mechanical transmission, such as a plunger that can move back and forth in the storage unit 213. The plunger is pivotally connected to one end of a pivot member, and the other end of the pivot member is pivotally connected to the brake unit 211, as shown in Figure 29. Preferably, an elastic body 215 is provided between the plunger and the storage unit 213. When the working medium in the balloon 131 needs to be transported to the storage unit 213, the brake unit 211 is rotated away from the housing 25 to provide a thrust to the plunger, thereby enabling the storage unit 213 to aspirate the working medium in the balloon 131. Furthermore, the elastic body 215 is provided between the end of the plunger and the end of the storage unit 213. The arrangement of the elastic body 215 is not limited to this, as long as it can push the plunger to achieve aspiration of the working medium in the balloon 131.

[0353] In another embodiment, the transmission unit 212 may be a motor, and the motor switch is actuated by the pivoting of the brake unit 211 to achieve the transmission of the working medium. The structure of the transmission unit 212 is not limited to this, as long as it can achieve the transmission of the working medium, and will not be described in detail here.

[0354] The storage unit 213 includes a delivery interface 2131, which is connected to the fluid pipeline 132 through a delivery pipeline fluid to deliver the working medium to the balloon 131 or to deliver the working medium in the balloon 131 to the storage unit 213. If there are two fluid pipelines 132, the delivery pipelines can be connected to the fluid pipelines 132 through Y-type interfaces, as shown in Figures 26 and 29. The storage unit 213 can be pre-loaded with working medium or not. Furthermore, an interface for connection to an external device can be provided on the delivery pipeline, through which the working medium can be delivered to the balloon 131 and / or the storage unit 213 and / or the working medium can be extracted or vacuumed from the balloon 131 and / or the storage unit 213, etc. A switch is provided at the interface. Preferably, the switch includes a puncturable self-sealing diaphragm, such as a silicone membrane. Optionally, the delivery interface 2131 is in fluid communication with the fluid conduit 132 via a three-way connector 214. As shown in FIG29 , the first and second interfaces of the three-way connector 214 respectively connect the delivery interface 2131 and the delivery conduit. The third interface of the three-way connector 214 can be connected to an external device to extract, deliver the working medium, and / or to create a vacuum. A switch on the three-way connector 214 can switch the fluid communication between the delivery interface 2131 and the delivery device, and between the delivery interface 2131 and the delivery conduit. When filling the balloon 131, the working medium of the delivery device can first be transferred to the storage unit 213 via the delivery interface 2131. Then, the switch is switched to transfer the working medium in the storage unit 213 to the balloon 131 via the delivery interface 2131. Alternatively, the connection between the balloon 131 and the storage unit 213 can be a connector of other shapes, as long as the connection between the storage unit 213 and the balloon 131 is ensured, the connection portion has an interface that can be connected to the outside world, and a switch is provided at the interface.

[0355] In addition, the transmission unit 212 and the storage unit 213 may be inside the housing 25 , or outside the housing 25 , or at least partially inside the housing 25 .

[0356] As shown in Figures 26, 29, and 30, the control assembly 2 further includes a locking unit 27, which is movably mounted on the housing 25. When the braking unit 211 rotates toward the housing 25 to inflate the balloon 131 to a predetermined state, the locking unit 27 can hold the braking unit 211, preventing the braking unit 211 from rotating away from the housing 25 and thus preventing the working medium in the balloon 131 from being discharged. Therefore, during the cutting process of the cutting device, even if the user does not apply force to the braking unit 211, the balloon 131 can remain in a filled state, ensuring the safety of the cutting process while also improving the convenience of device operation.

[0357] The locking unit 27 includes a second limiting member 271 and a second elastic member 272. The second limiting member 271 is movably disposed on the housing 25 and is used to limit the movement of the brake unit 211 when the balloon 131 is filled to a predetermined state, as shown in Figure 30(a). The second elastic member 272 can apply a force to the second limiting member 271, causing it to maintain a locked state with the brake unit 211 to limit the movement of the brake unit 211. Preferably, the second elastic member 272 is a torsion spring connected to the second limiting member 271. When the balloon 131 is filled to a predetermined state, the biasing action of the torsion spring causes the hook of the second limiting member 271 to engage with the brake unit 211, thereby preventing the brake unit 211 from rotating away from the housing 25.

[0358] Furthermore, the locking unit 27 also includes an unlocking member 273. When the balloon 131 needs to be deflated, the unlocking member 273 is toggled to push the other end of the second limiting member 271 relative to the hook. Through the lever action, the second limiting member 271 is deflected and disengaged from the braking unit 211. At this time, the braking unit 211 can rotate away from the housing 25, thereby unlocking the braking unit 211, as shown in Figure 30(b). The unlocking member 273 is preferably a protruding structure connected to the second limiting member 271. Optionally, the unlocking member 273 can also be separated from the second limiting member 271, as long as the second limiting member 271 can be deflected and disengaged from the braking unit 211.

[0359] In this embodiment, the specific process of tissue cutting is as follows: first, force is applied to the braking unit 211 to rotate it toward the shell 25, so as to actuate the transmission unit 212 to transport the working medium in the storage unit 213 to the balloon 131, so that the balloon 131 is filled and expanded. As shown in Figures 26 and 30 (a), the braking unit 211 slides over the end guide slope of the hook of the second limit member 271. Under the action of the second elastic member 272, the hook engages the braking unit 211, thereby locking the braking unit 211 and keeping the balloon 131 in a predetermined filling state; at this time, the cutting member 1111 is located at the distal end of the cutting body 1 and is in the knife-retracting position, as shown in Figure 24. Secondly, when the braking unit 211 rotates to a predetermined position and the balloon 131 is inflated to a predetermined state, the locking unit 27 maintains the braking unit 211 in the predetermined position, and the knife control unit 24 is rotated in a first direction so that the transmission member 1112 pushes the cutting member 1111 to pivot relative to the auxiliary unit 112, causing the cutting member 1111 to switch from the retracted position to the upright position. The cutting member 1111 is maintained in the predetermined upright position by the retaining structure, as shown in Figures 25 and 6. Thirdly, the actuator 281 is pressed to disengage the first limiting member 283 from the second positioning opening 26, pushing back the actuator unit 23 and driving the knife control unit 24 to move the cutting member 1111 within the opening 121 from the distal end of the opening 121 to the proximal end of the opening 121 to cut the tissue, as shown in Figure 31. Finally, when the tissue cutting is completed, the cutting member 1111 is located at the proximal end of the opening 121, and the knife control unit 24 is rotated in a second direction opposite to the first direction so that the transmission member 1112 pulls the cutting member 1111 to pivot relative to the auxiliary unit 112, so that the cutting member 1111 switches from the upright position to the retracted position; the unlocking member 273 is toggled to unlock the braking unit 211, so that the braking unit 211 rotates away from the shell 25, shrinks the balloon 131, and removes the device.

[0360] Furthermore, the cutting member 1111 may also have a double-edged structure. Based on this, when the cutting member 1111 moves from the distal end of the opening 121 to the proximal end of the opening 121 in the opening 121, the actuating unit 23 can be pushed and the knife control unit 24 can be driven to move the cutting member 1111 from the proximal end of the opening 121 to the distal end of the opening 121 in the opening 121 to continue cutting the tissue.

[0361] 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 percutaneous soft tissue cutting device, characterized in that: include: cutting components; A control assembly connected to the cutting assembly for controlling the cutting assembly so as to switch the cutting assembly between a knife-retracting position and a knife-standing position; Wherein, the cutting assembly comprises: sheath unit; a cutting unit, at least a portion of which is disposed within the sheath unit and connected to the control assembly, and configured to cause the cutting unit and the sheath unit to move relative to each other under control of the control assembly, so as to switch the cutting unit between a knife-retracting position and a knife-standing position; Wherein, in the knife-retracted position, the cutting end of the cutting unit is located inside the sheath unit; in the knife-standing position, at least a portion of the cutting end of the cutting unit is located outside the distal end of the sheath unit to cut tissue; Wherein, the control component includes: a housing unit, wherein at least a portion of the cutting assembly is disposed inside the housing unit; The knife control unit is arranged in the housing unit and is pivotally connected to the transmission end of the cutting unit, and is used to control the cutting unit so that the cutting unit and the sheath unit move relative to each other and the cutting unit switches between a knife-retracting position and a knife-standing position.

2. The soft tissue cutting device according to claim 1, characterized in that: The sheath unit comprises: a sheath element, wherein at least a portion of the cutting unit is disposed inside the sheath element; an opening element, the opening element being provided at the distal end section of the sheath element, for moving the cutting end of the cutting unit within the opening element under the control of the control assembly, and for positioning at least a portion of the cutting end of the cutting unit outside the opening element to cut tissue when the cutting end of the cutting unit is in a vertical knife position; and / or The cutting unit comprises: a cutting element movably disposed at the distal end of the sheath unit, wherein when the cutting element is in a knife-retracted position, the cutting element is located inside the distal end of the sheath unit, and when the cutting element is in a knife-up position, at least a portion of the cutting element is located outside the distal end of the sheath unit to cut tissue; The first transmission element is connected to the cutting element and the control component respectively, and is used to drive the cutting element to move at the distal end of the sheath unit under the control of the control component, so that the cutting element can switch between the knife-retracting position and the knife-standing position.

3. The soft tissue cutting device according to claim 2, characterized in that: The sheath unit further comprises: a scale element, the scale element being provided on the outer edge of the sheath element and being used to indicate the depth of the sheath element penetrating into the tissue; and / or The cutting unit further comprises: a first sliding element, which is disposed at a proximal end of the first transmission element and is slidably connected to the manipulation assembly; and / or The housing unit comprises: a housing element, within which at least a portion of the cutting assembly is disposed; and / or The knife control unit comprises: a rotating element, the rotating element being disposed inside the housing unit; A knife-controlling element is connected to the rotating element and is pivotally connected to the transmission end of the cutting unit, and is used for rotating under the action of the rotating element.

4. The soft tissue cutting device according to claim 3, characterized in that: The housing unit further comprises: a first positioning element, the first positioning element being provided on the housing element and located at a moving track of the knife control unit, for limiting a moving range of the knife control unit; and / or The knife control unit further includes: a first actuating element, the first actuating element being disposed at the top end of the rotating element and being used to control the rotating element; and / or The knife control unit further includes: a second sliding element, the second sliding element being disposed on the knife control element, eccentrically disposed with respect to the rotating element, and being slidably connected to the transmission end of the cutting unit; and / or The knife control unit further includes: a damping element, the damping element being arranged at a connection position between the knife control element and the rotating element for increasing damping; and / or The knife control unit further includes: A support element is arranged inside the housing unit and is connected to the rotating element and the knife control element respectively.

5. The soft tissue cutting device according to any one of claims 1 to 4, characterized in that: The cutting assembly further comprises: The balloon end of the balloon unit is arranged at the distal end of the sheath unit and is connected to the control component, and is used to fill the balloon end of the balloon unit to a predetermined state under the control of the control component, or The balloon end of the balloon unit is restored to its initial state under the control of The control component also includes: A fluid delivery unit is connected to the balloon unit of the cutting assembly and is used to deliver a working medium to the balloon unit to fill the balloon unit to a predetermined state, or to obtain the working medium delivered by the balloon unit to restore the balloon unit to an initial state.

6. The soft tissue cutting device according to claim 5, characterized in that: The balloon unit comprises: a balloon component, the balloon component being disposed at the distal end of the sheath unit; at least one fluid delivery element, a distal end portion of the fluid delivery element being in communication with the balloon element, and a proximal end portion of the fluid delivery element being in communication with the manipulation component, for delivering a working medium to the balloon element under the manipulation of the manipulation component to fill the balloon element to a predetermined state, or for delivering a working medium to the manipulation component under the manipulation of the manipulation component to restore the balloon element to an initial state; and / or The housing unit further comprises: a second positioning element, which is provided on the housing unit and is detachably connected to the actuating end of the fluid delivery unit, and is used to define the state of the fluid delivery unit; and / or The fluid delivery unit comprises: a storage element, the storage element being in communication with the balloon unit and being used to deliver a working medium to the balloon unit or to obtain the working medium delivered by the balloon unit; a second transmission element connected to the storage element; A second actuating element is connected to the second transmission element, and is used to actuate the second transmission element to enable the storage element to deliver the working medium to the balloon unit, or to enable the balloon unit to deliver the working medium to the storage element.

7. The soft tissue cutting device according to claim 6, characterized in that: The fluid delivery unit further comprises: a third positioning element, which is provided at an end of the second actuating element and is detachably connected to the housing unit, and is used to define a state of the second actuating element; and / or The fluid delivery unit further comprises: an elastic element, the elastic element being arranged between the storage element and the second transmission element; and / or The fluid delivery unit further comprises: A valve element is communicated with the storage element and is used for allowing the working medium to flow in one direction.

8. The soft tissue cutting device according to any one of claims 1 to 7, characterized in that: Also includes: A locking assembly is detachably provided on the sheath unit of the cutting assembly and is used to lock the depth of the sheath unit penetrating into the tissue.

9. The soft tissue cutting device according to claim 8, characterized in that: The locking assembly comprises: A locking unit is detachably provided on the sheath unit and is used to lock the depth of the sheath unit penetrating into the tissue.

10. The soft tissue cutting device according to claim 9, characterized in that: The locking unit comprises: a first locking element removably disposed on the sheath unit; A second locking element is removably provided on the sheath unit and detachably connected to the first locking element.

11. A percutaneous soft tissue cutting device, comprising a cutting body and a manipulation assembly, characterized in that: The cutting body comprises a cutting assembly and an outer sheath tube having an opening, wherein the opening is located at the distal end section of the outer sheath tube, and under the control of the control assembly, the cutting assembly can be moved relative to the outer sheath tube so that the cutting member of the cutting assembly moves in the opening to cut tissue; the cutting assembly comprises a cutting unit and an auxiliary unit, at least a portion of the cutting unit and at least a portion of the auxiliary unit are arranged in the outer sheath tube; the cutting unit comprises the cutting member and a transmission member, the cutting member being pivotally connected to the distal end section of the transmission member and the auxiliary unit respectively, and the transmission member being movable relative to the auxiliary unit; the proximal end section of the transmission member is connected to the control assembly, and under the control of the control assembly, the transmission member can cause the cutting member to pivot relative to the auxiliary unit so that the cutting member switches between a knife-retracting position and a knife-standing position; in the knife-retracting position, the cutting member is accommodated in the internal space of the outer sheath tube; In the upright knife position, at least a portion of the cutting member protrudes from the opening and is located outside the outer sheath.

12. The soft tissue cutting device according to claim 11, characterized in that: The transmission member includes an intermediate member and a force-applying member. The intermediate member is pivotally connected to the distal end section of the force-applying member and the cutting member respectively. The proximal end section of the force-applying member is connected to the control assembly.

13. The soft tissue cutting device according to claim 11 or 12, characterized in that: The device further comprises a retaining structure capable of retaining the cutting member in a predetermined position.

14. The soft tissue cutting device according to claim 13, wherein: The control assembly includes a knife control unit, which is connected to the proximal end section of the transmission member and can control the transmission member to cause the cutting member to pivot relative to the auxiliary unit; The knife control unit includes a rotation axis, and the knife control unit can rotate around the rotation axis to control the transmission member to cause the cutting member to perform a pivotal movement relative to the auxiliary unit.

15. The soft tissue cutting device according to claim 14, characterized in that: One of the knife control unit and the proximal section of the transmission member includes a slide groove, and the other of the knife control unit and the proximal section of the transmission member includes a sliding member. The slide groove has an arc-shaped surface, and the arc-shaped surface is eccentrically arranged relative to the rotating shaft. The sliding member cooperates with the arc-shaped surface so that when the knife control unit is rotated, the sliding member slides along the arc-shaped surface to control the transmission member to make the cutting member pivot relative to the auxiliary unit.

16. The soft tissue cutting device according to claim 15, characterized in that: The retaining structure is provided on the sliding groove.

17. The soft tissue cutting device according to claim 14, wherein: The knife control unit is provided with a tooth structure, and the proximal section of the transmission member is provided with a rack. By rotating the knife control unit, under the cooperation of the tooth structure and the rack, the transmission member is manipulated to cause the cutting member to pivot relative to the auxiliary unit.

18. The soft tissue cutting device according to any one of claims 14 to 17, characterized in that: The manipulation assembly further includes an actuating unit, which is movable relative to the housing of the device to enable the cutting element to cut the target tissue in a cutting direction.

19. The soft tissue cutting device according to claim 18, wherein: The actuating unit includes a manipulation member and a connecting member. The manipulation member is connected to the knife control unit via the connecting member. The rotating shaft of the knife control unit is pivotally connected to the connecting member.

20. The soft tissue cutting device according to claim 19, wherein: The proximal end section of the auxiliary unit is connected to the connecting member.

21. The soft tissue cutting device according to claim 18, wherein: The retaining structure also includes a first positioning component and a first positioning port. One of the actuating unit and the knife control unit includes the first positioning component, and the other of the actuating unit and the knife control unit includes the first positioning port. When the cutting member is located at the predetermined position, at least a portion of the first positioning component is located in the first positioning port to limit the rotation of the knife control unit.

22. The soft tissue cutting device according to claim 18, wherein: The manipulation assembly further includes a second positioning assembly and a second positioning port, wherein the second positioning assembly and the second positioning port cooperate to keep the knife control unit positioned at a target position.

23. The soft tissue cutting device according to claim 22, wherein: The second positioning assembly includes an actuating member, a first limiting member, and a first elastic member. Both ends of the elastic member are supported by the actuating member and the operating member of the actuating unit, respectively. The actuating member and the limiting member are connected to each other on both sides of the operating member. The second positioning port is arranged on the moving track of the control member; When the knife control unit is located at the target position, the elastic member enables the limit member to cooperate with the second positioning port to limit the movement of the actuating unit; when the knife control unit needs to leave the target position, the actuating member is pressed to drive the limit member to cooperate with the target position. The second positioning opening is disengaged.

24. The soft tissue cutting device according to any one of claims 11, 12, 14 to 17, and 19 to 23, characterized in that: The cutting body further comprises a balloon assembly, wherein the balloon assembly comprises at least one balloon and a fluid conduit, wherein the balloon is located at the distal end of the outer sheath and is in fluid communication with the fluid conduit; The control component also includes a fluid conveying mechanism, which includes the braking unit, a transmission unit and a storage unit. The storage unit is fluidically connected to the fluid pipeline. The pivotal movement of the braking unit can actuate the transmission unit to convey the working medium in the storage unit to the balloon, thereby filling the balloon to a predetermined state.

25. The soft tissue cutting device according to claim 24, characterized in that The manipulation assembly further includes a locking unit, which is movably disposed on the housing; when the balloon is inflated to the predetermined state, the locking unit can limit the pivotal movement of the braking unit to prevent the working medium in the balloon from being discharged.

26. The soft tissue cutting device according to claim 25, characterized in that The locking unit includes a second limiter and a second elastic member, the second limiter can be movably arranged on the shell of the device, and the second elastic member is connected to the second limiter. When the balloon is inflated to the predetermined state, the second elastic member can provide a biasing force to the second limiter to maintain the locking state of the second limiter and the braking unit.

27. The soft tissue cutting device according to claim 26, wherein: The locking unit further includes an unlocking member, and moving the unlocking member can drive the second limiting member to deflect and disengage from the braking unit.

28. The soft tissue cutting device according to claim 24, wherein: An interface that can be connected to an external device is provided between the storage unit and the fluid pipeline.

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