A continuous cryobiopsy sampling sheath with an openable and closable entrance and a sampling method

Abstract

The present invention proposes a continuous cryobiopsy sampling sheath with an openable and closable inlet and a sampling method, wherein the sampling sheath comprises: a handle unit and a sheath tube unit, wherein the handle unit comprises a telescopic unit and a process sleeve; the sheath tube unit comprises: a balloon sheath tube which is a hollow flexible catheter, comprising a balloon, a sheath tube balloon airway, a sample storage cavity, an opening and closing balloon and a sheath tube opening and closing balloon airway; the sheath tube balloon airway is opened in the balloon sheath tube and connects the handle shell balloon airway of the telescopic unit and the balloon of the sheath tube unit; the sheath tube opening and closing balloon The balloon airway is provided in the balloon sheath, connecting the opening and closing balloon and the handle housing opening and closing balloon airway of the telescopic unit. The handle housing opening and closing balloon airway is provided on the handle housing, and its proximal end is connected to the closed cavity. The telescopic unit includes a closed cavity, and the volume of the closed cavity changes as the telescopic unit expands and contracts, thereby allowing gas in the closed cavity to be injected into or withdrawn from the opening and closing balloon through the handle housing opening and closing balloon airway and the sheath opening and closing balloon airway, thereby expanding or contracting the opening and closing balloon. The distal opening of the sampling sheath of the present invention can be closed or opened as the biopsy needle is pushed out or retracted.

Description

Technical Field

[0001] The present invention belongs to the technical field of cryobiopsy, and in particular relates to a continuous cryobiopsy sampling sheath with an openable and closable inlet and a sampling method. Background Art

[0002] Cryobiopsy involves inserting the tip of a cryoprobe into the affected area of ​​the bronchus or lung via a bronchoscope. Refrigerant is then rapidly released into the tip. Due to the Joule-Thomson effect, the tip rapidly absorbs heat from the surrounding environment, freezing the surrounding tissue and adhering to the tip. The frozen tissue specimen, adhering to the probe tip, is then removed along with the probe, allowing the target tissue to be biopsied. Compared to forceps biopsy, cryobiopsy yields larger and more intact specimens, facilitating pathological analysis and diagnosis. Consequently, it has become a novel biopsy method for many respiratory diseases.

[0003] There are two main types of biopsy methods:

[0004] 1. The cryoprobe is directly inserted into the airway through the bronchoscope for biopsy. This method requires that the specifications of the cryoprobe and the bronchoscope are compatible with each other. Cryoprobes of different specifications must be used with bronchoscopes with different outer diameters and working channels. When using a bronchoscope with a larger outer diameter, the tip of the bronchoscope is often too far away from the lesion, making it difficult for the probe tip to accurately reach the lesion, thereby reducing the efficiency and accuracy of the biopsy. Since the outer diameter of the bronchoscope limits the diameter of the working channel, the smaller the outer diameter, the smaller the working channel. When using a bronchoscope with a smaller outer diameter, the specimen is often too large to enter the distal entrance of the bronchoscope, or the biopsy specimen is blocked in the working channel of the bronchoscope and cannot be removed. Then, the bronchoscope and cryoprobe need to be completely removed from the body. If multiple sampling is required, the bronchoscope needs to be repeatedly entered and exited from the airway, and after the specimen is removed, it is impossible to directly observe the situation in the bronchial cavity (such as whether there is bleeding, etc.), which reduces the efficiency of the biopsy and increases the difficulty of the biopsy.

[0005] 2. The cryoprobe is inserted into the airway through an extended sheath for biopsy. The currently used sheath cannot store specimens and requires the cryoprobe to be repeatedly inserted and removed from the sheath, which is also cumbersome.

[0006] Therefore, if Figure 27As shown, in the ultrafine cryobiopsy technology for peripheral lung lesions that are not visible under the existing bronchoscope, multiple cryobiopsy samples need to be taken from the same lesion area, and then the cryoprobe needs to be repeatedly moved in and out of the bronchoscope or sheath as a whole, or during bronchoscope cryobiopsy, the flexible bronchoscope and the cryoprobe need to be moved out of the body as a whole. At this time, the bronchoscope needs to enter and exit the airway multiple times, and the situation in the bronchial cavity cannot be directly observed immediately after the specimen is taken out, which reduces the efficiency of the biopsy and increases the difficulty of the biopsy.

[0007] Furthermore, existing techniques suffer from the problem that the distal opening of the sheath cannot close or open with the extension or retraction of the biopsy needle. Consequently, when multiple sampling is required, the tissue sample obtained from the previous sampling attempt may be carried out of the sheath along with the cryoprobe due to the sheath opening being fully open during the next sampling attempt. This results in the loss of the tissue sample, preventing the acquisition of multiple tissue samples and reducing biopsy efficiency. Summary of the Invention

[0008] The object of the present invention is to provide a continuous cryobiopsy sampling sheath with an openable and closable inlet and a sampling method, wherein the distal opening of the sampling sheath can be closed or opened along with the pushing out or withdrawing of the biopsy needle.

[0009] A continuous cryobiopsy sampling sheath with an openable and closable entrance, comprising:

[0010] The handle unit 11 is used to move the cryoprobe 2 and includes a telescopic unit and an advancement sleeve 115. The proximal opening of the advancement sleeve 115 is fixedly mounted on the outer wall of the telescopic unit, and the distal opening thereof is connected and fixedly connected to the entrance of the working channel of the bronchoscope.

[0011] and a sheath unit 12, comprising:

[0012] The balloon sheath 121 is a hollow flexible catheter, which includes a balloon 1211, a sheath balloon airway 1212, a sample storage cavity 1213, an opening and closing balloon 1214, and a sheath opening and closing balloon airway 1215. From the distal end to the proximal end, the opening and closing balloon 1214, the sample storage cavity 1213, and the balloon 1211 are arranged in sequence.

[0013] The sheath tube balloon airway 1212 is opened in the balloon sheath tube 121 and communicates with the handle shell balloon airway 1142 of the telescopic unit and the balloon 1211 of the sheath tube unit 12; the sheath tube opening and closing balloon airway 1215 is opened in the balloon sheath tube 121 and extends to the opening and closing balloon 1214, which communicates with the opening and closing balloon 1214 and the handle shell opening and closing balloon airway 1145 of the telescopic unit;

[0014] The handle housing opening and closing balloon airway 1145 is provided on the handle housing 114 of the handle unit 11, and its proximal end is communicated with the closed cavity. The telescopic unit includes a closed cavity. The volume of the closed cavity changes as the telescopic unit expands and contracts, so that the gas in the closed cavity is injected into or withdrawn from the opening and closing balloon 1214 through the handle housing opening and closing balloon airway 1145 and the sheath opening and closing balloon airway 1215, thereby expanding or contracting the opening and closing balloon 1214.

[0015] The opening and closing balloon 1214 is fixed to the inner wall of the distal end of the sample storage cavity 1213 and the distal opening of the balloon sheath 121;

[0016] The sample storage cavity 1213 is used to store the obtained tissue specimens in advance and is connected to the working channel of the telescopic unit through the working channel of the balloon sheath 121. The balloon 1211 is arranged on the outer wall of the balloon sheath 121 and behind the sample storage cavity 1213 and is used for dilating or blocking the airway.

[0017] The balloon sheath tube 121 passes through the process sleeve 115, and its proximal opening is connected and fixed to the distal opening of the handle unit 11; the working channel of the balloon sheath tube 121 is connected to the sample storage cavity 1213 and the working channel of the telescopic unit;

[0018] The scraper 122 is fixed at the junction of the working channel of the balloon sheath 121 and the sample storage cavity 1213. The cryoprobe 2 can pass through the inner hole of the scraper 122 to scrape the tissue sample from the tip surface of the cryoprobe 2.

[0019] And two developing rings 123 are both sleeved on the outer wall of the balloon sheath 121 , one of the developing rings 123 is located at the proximal end of the opening and closing balloon 1214 ; the other developing ring 123 is located at the position of the scraper 122 .

[0020] Preferably, the telescopic unit comprises: a movable sleeve 111, a sleeve 113 and a handle housing 114;

[0021] The movable sleeve 111 includes a No. 1 inner tube 1112 and a No. 1 outer tube 1111. The No. 1 inner tube 1112 is a through-slot structure, which is opened in the cavity of the No. 1 outer tube 1111 and the distal end extends outside the distal end of the No. 1 outer tube 1111. The inner cavity of the No. 1 inner tube 1112 is a working channel of the handle unit 11.

[0022] The sleeve 113 includes a second inner tube 1133 and a second outer tube 1132; the second inner tube 1133 is used to accommodate the third inner tube 1144 and the first inner tube 1112; the distal end of the second inner tube 1133 is located in the cavity of the third outer tube 1143; the second inner tube 1133 is coaxially arranged in the second outer tube 1132, and the distal end of the second inner tube 1133 is connected and fixed to the distal end of the second outer tube 1132 via a plurality of connecting ribs 1134;

[0023] The distal end of the second inner tube 1133 is provided with a plurality of elastic ribs 1131 radially distributed along the circumference of the second inner tube 1133 , and the elastic ribs 1131 and the connecting ribs 1134 are alternately distributed;

[0024] The elastic rib 1131 extends to the distal end of the second outer tube 1132 and expands from the second inner tube 1133 toward the inner wall of the third outer tube 1143 ;

[0025] The handle housing 114 includes a third inner tube 1144 and a third outer tube 1143. The third inner tube 1144 is a through-slot structure, which is opened in the cavity of the third outer tube 1143, and its proximal end extends outside the proximal end of the third outer tube 1143. The cavity of the third outer tube 1143 coaxially surrounds the third inner tube 1144.

[0026] The third outer tube 1143 is provided with a handle shell balloon airway 1142 and a handle shell opening and closing balloon airway 1145;

[0027] The handle housing balloon airway 1142 has a proximal end connected to the balloon inflation port 1141, which is in communication with the outside world; and a distal end connected to the sheath balloon airway 1212 of the balloon sheath 121;

[0028] The handle shell opens and closes the balloon airway 1145, and its proximal end is connected to the inner cavity of the third outer tube 1143; its distal end is connected to the sheath tube opening and closing balloon airway 1215 of the balloon sheath tube 121;

[0029] The first outer tube 1111, the second outer tube 1132, and the third outer tube 1143 are coaxially sleeved from the inside to the outside; the first inner tube 1112, the third inner tube 1144, and the second inner tube 1133 are coaxially sleeved from the inside to the outside; the first inner tube 1112 and the third inner tube 1144 form a working channel for accommodating the cryoprobe 2;

[0030] The spaces inside the No. 1 outer tube 1111 , the No. 2 outer tube 1132 and the No. 3 outer tube 1143 and the spaces outside the No. 2 inner tube 1133 and the No. 3 inner tube 1144 together form the closed cavity.

[0031] Preferably, the interior of the No. 1 outer tube 1111, the No. 2 inner tube 1133, and the No. 3 inner tube 1144 and the exterior of the No. 1 inner tube 1112 are enclosed to form a back pressure cavity, and the distal end of the pressure balancing airway 1113 is connected to the back pressure cavity; the pressure balancing airway 1113 is opened in the No. 1 outer tube 1111;

[0032] When the movable ferrule 111 is retracted, the space of the back pressure cavity becomes larger and generates negative pressure, and the external gas will enter the back pressure cavity through the pressure balance airway 1113 to ensure that the retraction action of the movable ferrule 111 is not affected by the pressure reduction in the back pressure cavity.

[0033] Preferably, the first outer tube 1111 and the second outer tube 1132 , as well as the second outer tube 1132 and the third outer tube 1143 , are sealed by the first sealing ring 1121 and the third sealing ring 1123 , respectively.

[0034] The No. 1 sealing ring 1121 is buckled in the distal ring groove of the No. 1 outer tube 1111 , and the No. 3 sealing ring 1123 is buckled in the distal ring groove of the No. 2 outer tube 1132 .

[0035] Preferably, the first inner tube 1112 and the third inner tube 1144 as well as the third inner tube 1144 and the second inner tube 1133 are sealed by the movable ferrule sealing ring 112 and the fourth sealing ring 1124 respectively;

[0036] The No. 1 outer tube 1111 and the No. 2 inner tube 1133 are sealed by the No. 2 sealing ring 1122; the movable ferrule sealing ring 112 is buckled in the distal ring groove of the No. 1 inner tube 1112, the No. 4 sealing ring 1124 is buckled in the proximal ring groove of the No. 3 inner tube 1144, and the No. 2 sealing ring 1122 is buckled in the proximal ring groove of the No. 2 inner tube 1133.

[0037] Preferably, it further comprises an air pressure regulating mechanism for regulating the air pressure in the cavity, which comprises an air pressure regulating knob 118, an adjusting air sealing ring gasket 1181 and an adjusting air sealing ring 1182;

[0038] A hollow adjustment column is fixed to the outer wall of outer tube 1143, defining an adjustment channel that communicates with the cavity of outer tube 1143. An adjustment gasket 1181 and an adjustment gasket 1182 are sequentially positioned within the adjustment channel, with adjustment gasket 1182 positioned adjacent to outer tube 1143.

[0039] A sampling method for a continuous cryobiopsy sampling sheath with an openable and closable inlet comprises the following steps:

[0040] Push the movable ferrule 111 into the sleeve 113. After the target tissue is frozen and adheres to the surface of the tip of the cryoprobe 2, the sleeve 113 is locked and immovable. The movable ferrule 111 is retracted and pulled out of the sleeve 113 until the distal end limit structure of the No. 1 outer tube 1111 of the movable ferrule 111 contacts the proximal end limit structure of the No. 2 outer tube 1132 of the sleeve 113. The movable ferrule 111 is completely pulled out of the sleeve 113, and the handle unit 11 returns to the fully extended state.

[0041] During this process, the tip of the cryoprobe 2 is pulled out along with the movable ferrule 111, and is passed from the target area through the opening and closing balloon 1214, the sample storage cavity 1213, and the inner hole of the scraper 122 into the working channel of the balloon sheath 121. The specimen tissue adhering to the surface of the tip of the cryoprobe 2 is torn off from the lesion site, and is pulled into the sample storage cavity 1213 along with the cryoprobe 2, and is scraped off by the hard scraper 122 and remains in the sample storage cavity 1213.

[0042] During the process of withdrawing the movable ferrule 111, the space of the closed cavity becomes larger and generates negative pressure, and the gas in the opening and closing balloon 1214 is drawn out through the opening and closing balloon airway 1145 of the handle shell and the opening and closing balloon airway 1215 of the sheath tube, and the opening and closing balloon 1214 contracts accordingly;

[0043] During the process of withdrawing the movable ferrule 111, the space of the back pressure cavity becomes larger and generates negative pressure, and the external gas will enter the back pressure cavity through the pressure balance airway 1113 to ensure that the withdrawal action of the movable ferrule 111 will not be affected by the pressure reduction in the back pressure cavity.

[0044] Preferably, before pushing the movable ferrule 111 into the sleeve 113, a step of fully expanding the fully contracted sampling sheath is further included, specifically comprising:

[0045] Step S1: Pull the movable ferrule 111 out of the sleeve 113:

[0046] Hold the grip area of ​​the handle housing 114 with one hand and keep it still. Hold the grip area of ​​the movable ferrule 111 with the other hand and pull the movable ferrule 111 backward. The first outer tube 1111 of the movable ferrule 111 moves backward in the cavity of the second outer tube 1132 of the sleeve 113. The first inner tube 1112 also moves backward in the third inner tube 1144 of the handle housing 114.

[0047] The distal end of the No. 1 outer tube 1111 of the movable ferrule 111 releases the extrusion of the distal elastic rib 1131 of the No. 2 inner tube 1133 of the sleeve 113, and the elastic rib 1131 expands toward the inner wall of the No. 3 outer tube 1143 of the handle housing 114, while the sleeve 113 as a whole remains stationary.

[0048] Pull the movable ferrule 111 backward until the distal stop structure of the No. 1 outer tube 1111 of the movable ferrule 111 contacts the proximal stop structure of the No. 2 outer tube 1132 of the sleeve 113, and the movable ferrule 111 is completely pulled out of the sleeve 113;

[0049] Step S2: Pull the sleeve 113 out of the handle housing 114.

[0050] Continue to pull the movable ferrule 111 backward, and the No. 1 outer tube 1111 of the movable ferrule 111 drives the No. 2 outer tube 1132 of the sleeve 113 to move backward, and the No. 2 outer tube 1132 drives the No. 2 inner tube 1133 fixed thereto to move backward together, and the elastic rib 1131 at the distal end of the No. 2 inner tube 1133 slides closely against the inner wall of the No. 3 outer tube 1143 of the handle housing 114;

[0051] When the distal limiting structure of the sleeve 113 contacts the proximal limiting structure of the No. 3 outer tube 1143 of the handle shell 114, the No. 2 outer tube 1132 of the sleeve 113 is pulled out from the No. 3 outer tube 1143 of the handle shell 114, and at the same time, the elastic rib 1131 is stuck in the limiting groove on the inner wall of the No. 3 outer tube 1143. The No. 2 outer tube 1132 of the sleeve 113 is no longer and cannot move, and the sleeve 113 is completely pulled out of the handle shell 114. At this time, the handle unit 11 is completely unfolded.

[0052] Preferably, if the distance between the lesion location and the distal opening of the balloon sheath 121 is less than 4 cm, the movable sleeve 111 does not need to be fully pushed into the inner cavity of the sleeve 113 to allow the tip of the freezing probe 2 to reach the lesion location; if the distance between the lesion location and the distal opening of the balloon sheath 121 is greater than 4 cm, the No. 1 outer tube 1111 of the movable sleeve 111 needs to be fully pushed into the inner cavity of the No. 2 outer tube 1132.

[0053] Compared with the existing technology, the advantages of the present invention are: the distal entrance of the sampling sheath can be opened and closed, and the continuous frozen biopsy sampling sheath is provided with a specimen storage area. The sheath opening can be closed or opened along with the push-out or retraction of the biopsy needle, ensuring that the tissue specimen adhering to the tip of the biopsy needle can smoothly enter the specimen storage area of ​​the sheath when the biopsy needle is withdrawn, and the tissue specimen remaining in the specimen storage area will not be removed when the biopsy needle is pushed out. Specifically:

[0054] 1. The opening at the distal end of the sheath (the end away from the operator, where the sample enters the sheath) can be closed or opened as the biopsy needle is pushed out or withdrawn. When the biopsy needle is withdrawn, the distal opening of the sheath opens, allowing tissue specimens adhering to the tip of the biopsy needle to smoothly enter the specimen storage area of ​​the sheath. When the biopsy needle is pushed out, the distal opening of the sheath closes, preventing the specimen remaining in the storage area from being removed from the sheath by the biopsy needle.

[0055] 2. Multiple continuous cryobiopsy can be performed without moving the bronchoscope and sheath.

[0056] 3. Temporarily store the specimen in the specimen storage area. After the biopsy is completed, remove the specimen together with the sheath, and then collect the specimen into the preservation solution.

[0057] 4. A specimen stripping device is provided at the proximal end of the specimen storage area (close to the operator), which can quickly strip the acquired specimen from the surface of the biopsy needle tip.

[0058] 5. A balloon can be provided at the distal end of the sheath, which can be used as a means of expansion to increase the diameter of the bronchus, and can also be used as a blocking balloon to avoid heavy bleeding during the biopsy process.

[0059] 6. The handle adopts a graded telescopic scheme, that is, the next level of telescopic movement is activated only when the previous level is extended to the limit position, so that the insertion depth of the cryoprobe can be clearly understood.

[0060] 7. The handle is provided with a length adjustment structure for the sheath extending out of the bronchoscope, which can adjust the length of the distal end of the sheath extending through the bronchoscope according to clinical needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 Schematic diagram of a continuous cryobiopsy sampling sheath with an openable and closable entrance;

[0062] Figure 2 This is a comparison of the front and side views of the sampling sheath when it is fully deployed;

[0063] Figure 3 It is a cross-sectional view of the sampling sheath and a partial enlarged schematic diagram;

[0064] Figure 4 This is a schematic diagram of the working principle of the fastening bolt;

[0065] Figure 5 (a) is a schematic diagram of the sleeve;

[0066] Figure 5 (b) is a cross-sectional view of the sleeve;

[0067] Figure 5 (c) is a schematic diagram of the convex ring;

[0068] Figure 6 Schematic diagram of the distal end of the balloon sheath;

[0069] Figure 7 This is a schematic diagram of the connection between the sheath balloon airway and the handle shell balloon airway;

[0070] Figure 8 It is a schematic diagram showing the connection between the sheath tube opening and closing balloon airway and the handle housing opening and closing balloon airway;

[0071] Figure 9 Schematic diagram of the distribution of sheath balloon airway and sheath opening and closing balloon airway;

[0072] Figure 10 Schematic diagram of the scale of the handle housing;

[0073] Figure 11 This is a schematic diagram of the connection between the cryoprobe and the movable ferrule;

[0074] Figure 12 Schematic diagram of elastic rib locking;

[0075] Figure 13 This is a schematic diagram showing the cryoprobe is flush with the opening of the balloon sheath;

[0076] Figure 14 This is a schematic diagram of the balloon opening and closing status when the cryoprobe is pushed forward;

[0077] Figure 15 Schematic diagram of the balloon opening and closing state when retracting the cryoprobe;

[0078] Figure 16 Schematic diagram of the scale of the movable card sleeve;

[0079] Figure 17 This is a schematic diagram of the convex ring on the inner wall of the sleeve buckled in the ring groove at the distal end of the movable ferrule;

[0080] Figure 18 Schematic diagram of elastic rib compression;

[0081] Figure 19 Schematic diagram of the scale of the sleeve;

[0082] Figure 20 It is a schematic diagram of the air pressure regulating mechanism of the closed cavity;

[0083] Figure 21 Schematic diagram of the freezing probe tip entering the sample storage cavity;

[0084] Figure 22 This is the structural diagram of the activity card set;

[0085] Figure 23 It is the structural diagram of the sleeve;

[0086] Figure 24 This is a structural diagram of the handle housing;

[0087] Figure 25 Schematic diagram of the initial state;

[0088] Figure 26 is a schematic diagram of the contact between the various limiting structures in the fully deployed state;

[0089] Figure 27 The process of repeatedly withdrawing and extending the sheath of the cryoprobe to obtain specimens multiple times and store them in the specimen storage cavity;

[0090] FIG28 is a schematic diagram of the flow direction of gas in the closed cavity during forward / retracting;

[0091] Figure 29 (a) is a schematic diagram of the flow direction of gas in the back pressure cavity during forward thrust;

[0092] Figure 29 (b) is a schematic diagram of the flow direction of gas in the back pressure cavity during withdrawal;

[0093] Among them, 1-sampling sheath;

[0094] 11-handle unit, 111-movable ferrule, 1111-outer tube No. 1, 1112-inner tube No. 1, 1113-pressure balance airway;

[0095] 112-movable card sleeve sealing ring, 1121-No. 1 sealing ring, 1122-No. 2 sealing ring, 1123-No. 3 sealing ring, 1124-No. 4 sealing ring;

[0096] 113-sleeve, 1131-elastic rib, 1132-No. 2 outer tube, 1133-No. 2 inner tube, 1134-connecting rib, 1135-convex ring;

[0097] 114-handle shell, 1141-balloon inflation port, 1142-balloon airway in the handle shell, 1143-No. 3 outer tube, 1144-No. 3 inner tube, 1145-handle shell opening and closing balloon airway;

[0098] 115-process casing; 116-fastening bolt; 117-adapter fixing piece;

[0099] 118-air pressure adjustment knob, 1181-adjusting air sealing ring gasket, 1182-adjusting air sealing ring;

[0100] 12-Sheath Unit,

[0101] 121-balloon sheath, 1211-balloon, 1212-sheath balloon airway, 1213-sample storage chamber, 1214-opening and closing balloon, 1215-sheath opening and closing balloon airway;

[0102] 122-scraper; 123-developing ring;

[0103] 2- Cryoprobe. DETAILED DESCRIPTION

[0104] The following, in conjunction with schematic diagrams, describes in more detail the continuous cryobiopsy sampling sheath with an openable and closable inlet and the sampling method of the present invention. Preferred embodiments of the present invention are shown. It should be understood that those skilled in the art may modify the present invention described herein while still achieving the beneficial effects of the present invention. Therefore, the following description should be understood as generally known to those skilled in the art and is not intended to limit the present invention.

[0105] like Figures 1 to 26A continuous cryobiopsy sampling sheath with an openable and closable entrance comprises: a handle unit 11 and a sheath unit 12. The handle unit 11 is used to move the cryoprobe 2, and the sheath unit 12 is used to transport the cryoprobe, temporarily store specimens, etc.

[0106] The handle unit 11 is composed of a movable ferrule 111 , a movable ferrule sealing ring 112 , a sleeve 113 , a handle housing 114 , a process sleeve 115 , a fastening bolt 116 , an adapter fixing 117 , and an air pressure regulating knob 118 .

[0107] like Figure 3 、 Figure 22 As shown, the movable sleeve 111 includes a No. 1 inner tube 1112 and a No. 1 outer tube 1111.

[0108] Inner tube No. 1112 is a through-slot structure, extending within the cavity of outer tube No. 1111, with its distal end extending beyond the distal end of outer tube No. 1111. Its inner cavity serves as the working channel of handle unit 11. The cavity of outer tube No. 1111 coaxially surrounds inner tube No. 1112, and an external convex ring is provided at the distal end of outer tube No. 1111 as a stop.

[0109] like Figure 3 、 Figure 23 As shown in FIG. 5 ( a ) to FIG. 5 ( c ), the sleeve 113 includes a second inner tube 1133 and a second outer tube 1132 .

[0110] The second inner tube 1133 is used to accommodate the third inner tube 1144 and the first inner tube 1112; the distal end of the second inner tube 1133 is located in the cavity of the third outer tube 1143. The second inner tube 1133 is coaxially arranged within the second outer tube 1132, and the distal end of the second inner tube 1133 is fixedly connected to the distal end of the second outer tube 1132 via a plurality of connecting ribs 1134.

[0111] The distal end of the second inner tube 1133 is provided with a plurality of elastic ribs 1131 radially distributed along the circumference of the second inner tube 1133 , and the elastic ribs 1131 and the connecting ribs 1134 are alternately distributed.

[0112] The elastic rib 1131 extends to the distal end of the second outer tube 1132 and expands from the second inner tube 1133 to the inner wall of the third outer tube 1143 in a trumpet shape.

[0113] The inner convex ring provided at the proximal end and the outer convex ring provided at the distal end of the second outer tube 1132 both serve as limiting structures (as shown in FIG. 5 ( a ) and FIG. 5 ( b )).

[0114] like Figure 3 、 Figure 24 As shown, the handle housing 114 includes a No. 3 inner tube 1144 and a No. 3 outer tube 1143. A scale is provided on the outer wall of the No. 3 outer tube 1143.

[0115] The third inner tube 1144 is a through-slot structure, which is opened in the cavity of the third outer tube 1143 , and its proximal end extends out of the proximal end of the third outer tube 1143 .

[0116] The cavity of the third outer tube 1143 coaxially surrounds the third inner tube 1144 .

[0117] Similarly, the inner convex ring provided at the proximal end and the outer convex ring provided at the distal end of the No. 3 outer tube 1143 are also limiting structures.

[0118] like Figure 3 As shown, the third outer tube 1143 is provided with a handle shell balloon airway 1142 and a handle shell opening and closing balloon airway 1145 .

[0119] The handle shell balloon airway 1142, the proximal end of which is connected to the balloon inflation port 1141 (such as Figure 3 As shown), the balloon inflating port 1141 is connected to the outside; its distal end is connected to the sheath balloon airway 1212 of the balloon sheath 121 (as Figure 7 shown).

[0120] The handle shell opens and closes the balloon airway 1145, the proximal end of which is connected to the inner cavity of the third outer tube 1143 (such as Figure 3 As shown), its distal end is connected to the sheath tube opening and closing balloon airway 1215 of the sheath tube 121 (as shown Figure 8 shown).

[0121] The first outer tube 1111, the second outer tube 1132 and the third outer tube 1143 are coaxially sleeved in sequence from the inside to the outside.

[0122] The first and second outer tubes 1111 and 1132, as well as the second and third outer tubes 1143, are sealed by sealing rings 1121 and 1123, respectively. Sealing ring 1121 is buckled into the annular groove at the distal end of outer tube 1111, while sealing ring 1123 is buckled into the annular groove at the distal end of outer tube 1132.

[0123] The first inner tube 1112 , the third inner tube 1144 , and the second inner tube 1133 are coaxially sleeved in sequence from the inside to the outside.

[0124] The seals between the No. 1 inner tube 1112 and the No. 3 inner tube 1144, and between the No. 3 inner tube 1144 and the No. 2 inner tube 1133 are respectively provided by a movable ferrule seal ring 112 and a No. 4 seal ring 1124. Furthermore, the seal between the No. 1 outer tube 1111 and the No. 2 inner tube 1133 is provided by a No. 2 seal ring 1122. The movable ferrule seal ring 112 is buckled into the distal annular groove of the No. 1 inner tube 1112, the No. 4 seal ring 1124 is buckled into the proximal annular groove of the No. 3 inner tube 1144, and the No. 2 seal ring 1122 is buckled into the proximal annular groove of the No. 2 inner tube 1133.

[0125] The inner space of the No. 1 outer tube 1111, the No. 2 outer tube 1132 and the No. 3 outer tube 1143 and the outer space outside the No. 2 inner tube 1133 and the No. 3 inner tube 1144 are combined to form a closed cavity, and the proximal end of the handle shell opening and closing balloon airway 1145 is connected to the closed cavity (such as Figure 28 As shown in the figure, the “spots” represent the gas in the closed cavity, the area covered by the “spots” is the closed cavity, and the arrow in the closed cavity indicates the direction of gas flow).

[0126] The interior of outer tube No. 1111, inner tube No. 2 1133 and inner tube No. 3 1144 and the exterior of inner tube No. 1 1112 together form a back pressure cavity, and the distal end of the pressure balance airway 1113 is connected to the back pressure cavity (as shown in FIG. 29 (a) and FIG. 29 (b), where “+” represents the gas in the back pressure cavity, the area covered by “+” is the back pressure cavity, and the arrow in the back pressure cavity indicates the direction of gas flow).

[0127] Among them, the pressure balance airway 1113 is opened in the No. 1 outer tube 1111.

[0128] The cavity of the No. 1 outer tube 1111 and the cavity of the No. 3 outer tube 1143 are both used to accommodate the No. 2 inner tube 1133;

[0129] The cavity of the third outer tube 1143 is used to accommodate the elastic rib 1131;

[0130] The inner wall of the third outer tube 1143 is provided with a limiting groove for positioning the elastic rib 1131 of the second inner tube 1133 to lock the sleeve 113;

[0131] The first inner tube 1112 and the third inner tube 1144 form a working channel for accommodating two cryoprobes.

[0132] like Figure 3 As shown, the process sleeve 115 is coaxially sleeved on the scale section of the handle shell 114 (the outer wall of the No. 3 outer tube 1143 is provided with a scale), and its proximal end is provided with an inner convex ring as a limiting structure, and its distal opening is provided with a Luer thread, which can be connected and locked with the working channel entrance of the bronchoscope.

[0133] The fastening bolt 116 passes through the threaded side hole of the process sleeve 115. By rotating the fastening bolt 116 clockwise or counterclockwise, the front end plane of the fastening bolt 116 and the scale segment side plane of the handle housing 114 can be squeezed or separated from each other, thereby achieving locking and unlocking between the process sleeve 115 and the handle housing 114. Figure 4 、 Figure 10 shown.

[0134] like Figure 20As shown, the air pressure regulating knob 118, the regulating air sealing ring gasket 1181 and the regulating air sealing ring 1182 constitute a mechanism for regulating the air pressure in the closed cavity (the space within the No. 1 outer tube 1111, the No. 2 outer tube 1132 and the No. 3 outer tube 1143 and the space outside the No. 2 inner tube 1133 and the No. 3 inner tube 1144). The mechanism is arranged at the No. 3 outer tube 1143. By rotating the air pressure regulating knob 118 clockwise / counterclockwise, the regulating air sealing ring 1182 is indirectly squeezed / stretched through the regulating air sealing ring gasket 1181 to achieve the closing / opening of the inner hole of the regulating air sealing ring 1182, thereby achieving the purpose of isolating / connecting the closed cavity with the outside world, and then allowing the gas in the closed cavity to enter and exit in a controllable manner to meet the purpose of regulating the pressure in the closed cavity.

[0135] The connection relationship between the air pressure regulating knob 118, the regulating air sealing ring gasket 1181 and the regulating air sealing ring 1182 is as follows:

[0136] A hollow adjustment column is fixed to the outer wall of outer tube 1143, defining an adjustment channel that communicates with the cavity of outer tube 1143. An adjustment gasket 1181 and an adjustment gasket 1182 are sequentially positioned within the adjustment channel, with adjustment gasket 1182 positioned adjacent to outer tube 1143.

[0137] The air pressure regulating knob 118 is threadedly connected to the outer wall of the regulating column and abuts against the regulating air sealing ring gasket 1181 .

[0138] The sheath unit 12 is composed of a balloon sheath 121, a scraper 122 and a developing ring 123. Figure 6 shown.

[0139] like Figure 13 As shown, the balloon sheath 121 is a hollow flexible catheter, which includes a balloon 1211, a sheath balloon airway 1212, a sample storage cavity 1213, an opening and closing balloon 1214 and a sheath opening and closing balloon airway 1215.

[0140] On the balloon sheath 121, from the distal end to the proximal end, there are an opening and closing balloon 1214, a sample storage cavity 1213 and a balloon 1211 (such as Figure 6 shown).

[0141] The opening and closing balloon 1214 is located at the distal opening of the balloon sheath 121; the sample storage cavity 1213 is located between the working channel of the balloon sheath 121 and the opening and closing balloon 1214, which is an area with an inner diameter larger than the working channel, and is used to collect and temporarily store the obtained tissue specimens; the balloon 1211 is set on the outer wall of the balloon sheath 121.

[0142] The sheath balloon airway 1212 is opened in the balloon sheath 121 .

[0143] The sheath opening and closing balloon airway 1215 is opened in the balloon sheath 121 and extends to the opening and closing balloon 1214 .

[0144] The opening and closing balloon 1214 is fixed to the inner wall of the sample storage cavity 1213 and is connected to the sheath tube opening and closing balloon airway 1215 .

[0145] The proximal end of the balloon sheath 121 is glued and sealed to the distal end of the handle housing 114, so that the working channel of the handle unit 11 and the working channel of the sheath unit 12 are connected. Figure 7 shown.

[0146] The proximal end of the sheath balloon airway 1212 is connected to the distal end of the handle housing balloon airway 1142 (eg Figure 7 As shown), the distal end thereof is passed into the inner side of the balloon 1211, and the balloon 1211 can be expanded / contracted by inflating / evacuating air through the balloon inflation port 1141.

[0147] The sheath opening and closing balloon airway 1215 connects the handle housing opening and closing balloon airway 1145 with the opening and closing balloon 1214 (eg Figure 8 As shown in the figure, by pushing forward / retracting the movable sleeve 111, the space in the closed cavity (the space within the No. 1 outer tube 1111, the No. 2 outer tube 1132 and the No. 3 outer tube 1143 and the space outside the No. 2 inner tube 1133 and the No. 3 inner tube 1144) is compressed / expanded, so that the gas in the closed cavity is injected into / extracted from the opening and closing balloon 1214 through the sheath opening and closing balloon airway 1215, and the non-compliant opening and closing balloon 1214 will expand / contract accordingly.

[0148] The scraper 122 is fixed at the junction of the working channel of the balloon sheath 121 and the sample storage cavity 1213 (such as Figure 6 As shown in FIG, during the process of the cryoprobe 2 entering the working channel of the balloon sheath 121 from the sample storage cavity 1213 through the inner hole of the scraper 122, the tissue specimen adhering to the surface of the tip of the cryoprobe 2 is scraped off and remains in the sample storage cavity 1213.

[0149] The two developing rings 123 are both sleeved on the outer wall of the balloon sheath 121 (eg Figure 6 As shown), one of the developing rings 123 is located slightly behind the opening and closing balloon 1214 to avoid affecting the radial expansion of the opening and closing balloon 1214; the other developing ring 123 is located at the position of the scraper 122, so that the opening of the balloon sheath 121 and the position of the scraper 122 can be clearly observed under CT or ultrasound imaging.

[0150] The tip of the cryoprobe 2 enters from the proximal opening of the handle unit 11 , passes through the handle unit 11 , the working channel of the balloon sheath 121 , the sample storage cavity 1213 and the opening and closing balloon 1214 , and extends from the distal opening of the balloon sheath 121 .

[0151] In clinical application, the distal end of the sheath unit 12 extends from the distal opening of the bronchoscope through the working channel of the bronchoscope, and the distal opening of the process sleeve 115 is threadedly connected and locked with the working channel entrance of the bronchoscope. The fastening bolt 116 is rotated counterclockwise to unlock the handle shell 114 (the scale section of the handle shell 114 can slide axially in the inner cavity of the process sleeve 115). According to actual clinical needs, the length of the distal end of the balloon sheath 121 extending from the front end of the bronchoscope is adjusted according to the scale indication on the scale section of the handle shell 114 (such as Figure 10 The tip of the cryoprobe 2 enters the sampling sheath 1 from the proximal entrance of the movable ferrule 111, and extends from the distal opening of the balloon sheath tube 121 through the working channel. The proximal buckle of the cryoprobe 2 is clamped and fixed with the slot at the entrance of the movable ferrule 111 (as shown). Figure 11 As shown, the cryoprobe 2 slides forward and backward with the movable ferrule 111. The working channel formed by the first inner tube 1112 and the third inner tube 1144 allows the cryoprobe 2 to pass through. Because the working channel of the sampling sheath 1 is only slightly larger than the outer diameter of the cryoprobe 2, the cryoprobe 2 is protected from bending and damage during the advancement and retraction of the movable ferrule 111.

[0152] From the above, it can be seen that the sampling sheath has the following advantages:

[0153] 1. The sheath and bronchoscope can be relatively fixed, and continuous multiple frozen biopsies can be performed without moving the bronchoscope and sheath during the biopsy process.

[0154] 2. The cryoprobe does not need to be moved in and out of the bronchoscope or sheath multiple times. After freezing, it only needs to be slightly withdrawn. After the specimen is separated from the cryoprobe, the sheath can be extended again for the next cryobiopsy.

[0155] 3. The specimen can be temporarily stored in the sheath without falling off, which is convenient for improving the efficiency of specimen collection.

[0156] 4. The distal opening of the sheath can be closed or opened as the biopsy needle is pushed out or withdrawn. When the biopsy needle is withdrawn, the distal opening of the sheath opens to facilitate the entry of the specimen into the specimen storage area of ​​the sheath. When the biopsy needle is pushed out, the distal opening of the sheath closes to prevent the specimen remaining in the storage area from being removed from the sheath by the push-out of the biopsy needle.

[0157] 5. It has an expansion part, which can play a role of blocking and expansion.

[0158] Working principle of the sampling sheath:

[0159] like Figure 25As shown, the initial state is that the handle unit 11 is fully retracted: the No. 1 outer tube 1111 of the movable ferrule 111 is completely retracted into the No. 2 outer tube 1132 , and the No. 2 outer tube 1132 of the sleeve 113 is completely retracted into the No. 3 outer tube 1143 .

[0160] Step S1: Pull the movable ferrule 111 out of the sleeve 113:

[0161] Hold the grip area of ​​the handle housing 114 with one hand and keep it still. Hold the grip area of ​​the movable ferrule 111 with the other hand and pull the movable ferrule 111 backward. The first outer tube 1111 of the movable ferrule 111 moves backward in the cavity of the second outer tube 1132 of the sleeve 113. The first inner tube 1112 also moves backward in the third inner tube 1144 of the handle housing 114.

[0162] The distal end of the No. 1 outer tube 1111 of the movable ferrule 111 releases the extrusion of the distal elastic rib 1131 of the No. 2 inner tube 1133 of the sleeve 113, and the elastic rib 1131 expands toward the inner wall of the No. 3 outer tube 1143 of the handle housing 114, while the sleeve 113 as a whole remains stationary.

[0163] Among them, the reason why the sleeve 113 remains stationary as a whole is that there is smooth contact between the No. 1 outer tube 1111 and the No. 2 outer tube 1132, as well as between the No. 1 outer tube 1111 and the No. 2 inner tube 1133, so only relative sliding occurs and the sleeve 113 remains stationary.

[0164] Pull the movable ferrule 111 backward until the distal limit structure of the No. 1 outer tube 1111 of the movable ferrule 111 contacts the proximal limit structure of the No. 2 outer tube 1132 of the sleeve 113, and the movable ferrule 111 is completely pulled out of the sleeve 113. Figure 26 shown.

[0165] Step S2: Pull the sleeve 113 out of the handle housing 114.

[0166] Continue to pull the movable ferrule 111 backward, and the No. 1 outer tube 1111 of the movable ferrule 111 drives the No. 2 outer tube 1132 of the sleeve 113 to move backward, and the No. 2 outer tube 1132 drives the No. 2 inner tube 1133 fixed thereto to move backward together, and the elastic rib 1131 at the distal end of the No. 2 inner tube 1133 slides closely against the inner wall of the No. 3 outer tube 1143 of the handle housing 114;

[0167] When the distal limiting structure of the sleeve 113 contacts the proximal limiting structure of the third outer tube 1143 of the handle housing 114, the second outer tube 1132 of the sleeve 113 is pulled out of the third outer tube 1143 of the handle housing 114, and the elastic rib 1131 is clamped in the limiting groove on the inner wall of the third outer tube 1143 (as shown in FIG. Figure 12As shown in FIG2 ), the second outer tube 1132 of the sleeve 113 is no longer and cannot be moved, and the sleeve 113 is completely pulled out of the handle housing 114. At this time, the handle unit 11 is fully unfolded (as shown in FIG2 ). Figure 2 、 Figure 3 、 Figure 26 As shown), and the No. 1 inner tube 1112 is still located in the No. 3 inner tube 1144 and the No. 2 inner tube 1133, that is, the working channel of the handle unit composed of the No. 1 inner tube 1112 and the No. 3 inner tube 1144 always remains sealed (the movable ferrule sealing ring 112 acts between the No. 1 inner tube 1112 and the No. 3 inner tube 1144) and unobstructed during the process from the handle unit 11 being fully contracted to fully expanded.

[0168] Step S3: insert the cryoprobe 2 into the sampling sheath 1 and fix it firmly.

[0169] The tip of the cryoprobe 2 enters the sampling sheath 1 through the proximal entrance of the movable ferrule 111 and extends into the balloon sheath tube 121 through the working channel. The proximal buckle of the cryoprobe 2 is clamped and fixed with the slot at the entrance of the movable ferrule 111 (as shown in FIG. Figure 11 As shown), the freezing probe 2 slides back and forth with the movable sleeve 111.

[0170] At this time, the tip of the cryoprobe 2 is at the rear end of the scraper 122 (as shown in FIG. Figure 6 As shown in FIG), the elastic rib 1131 end of the sleeve 113 is inserted into the limiting groove on the inner wall of the third outer tube 1143 of the handle housing 114 (as shown in FIG). Figure 12 As shown), the sleeve 113 is prevented from sliding randomly to affect the confirmation of the insertion depth of the freezing probe 2.

[0171] Step S4: Push the movable sleeve 111 into the sleeve 113 (the sleeve 113 is locked and cannot move):

[0172] Push the movable ferrule 111 forward. At this time, hold the handle housing 114 with one hand and keep it still. When the scale value on the scale section of the movable ferrule 111 (the outer wall of the No. 1 outer tube 1111 of the movable ferrule 111 is provided with a scale) is greater than 0 (when it is equal to 0, it means that the tip of the cryoprobe 2 is flush with the opening of the balloon sheath tube 121, as shown in the figure below), the movable ferrule 111 is pushed forward. At this time, hold the handle housing 114 with one hand and keep it still. When the scale value on the scale section of the movable ferrule 111 (the outer wall of the No. 1 outer tube 1111 of the movable ferrule 111 is provided with a scale) is greater than 0 (when it is equal to 0, it means that the tip of the cryoprobe 2 is flush with the opening Figure 13 As shown in FIG), it indicates that the tip of the cryoprobe 2 has extended from the opening of the balloon sheath 121. The process of pushing the cryoprobe 2 out of the balloon sheath 121 is as follows. Figure 14 shown.

[0173] If the distance between the lesion location and the distal opening of the balloon sheath 121 is small (<4 cm), the movable sleeve 111 does not need to be fully pushed into the inner cavity of the sleeve 113 to allow the tip of the cryoprobe 2 to reach the lesion location, so the elastic rib 1131 will not be triggered, and the sleeve 113 will not slide with the advancement / retraction of the movable sleeve 111. The distance the movable sleeve 111 is pushed forward is the length of the extended cryoprobe 2. Therefore, by reading the scale value on the scale segment of the movable sleeve 111, the insertion depth of the cryoprobe 2 can be clearly grasped.

[0174] Step S5: After the target tissue is frozen and adhered, the movable ferrule 111 is withdrawn.

[0175] According to the specific location of the lesion, steps S1, S2, S3 and S4 are completed, the tip of the freezing probe 2 is attached to the surface of the target tissue, and freezing is started.

[0176] After the target tissue is frozen and adheres to the surface of the tip of the freezing probe 2, the sleeve 113 is locked and the movable ferrule 111 is retracted. The movable ferrule 111 is pulled out of the sleeve 113 until the distal limit structure of the No. 1 outer tube 1111 of the movable ferrule 111 contacts the proximal limit structure of the No. 2 outer tube 1132 of the sleeve 113. The movable ferrule 111 is completely pulled out of the sleeve 113, and the handle unit 11 returns to the fully expanded state.

[0177] During this process, the tip of the cryoprobe 2 is pulled out along with the movable ferrule 111, and is passed from the target area through the opening and closing balloon 1214, the sample storage cavity 1213, and the inner hole of the scraper 122 into the working channel of the balloon sheath 121. The specimen tissue adhering to the surface of the tip of the cryoprobe 2 is torn off from the lesion site, and is pulled into the sample storage cavity 1213 along with the cryoprobe 2, and is scraped off by the hard scraper 122 and remains in the sample storage cavity 1213.

[0178] Since the freezing probe 2 is kept in the frozen open state during the process of withdrawing from the lesion position through the opening and closing balloon 1214 into the sample storage cavity 1213, there is a strong adhesion force between the tip surface of the freezing probe 2 and the specimen tissue, which can ensure that the specimen tissue will not fall off when passing through the opening and closing balloon 1214.

[0179] Moreover, in the process of withdrawing the movable sleeve 111, the space of the closed cavity (the space inside the No. 1 outer tube 1111, the No. 2 outer tube 1132 and the No. 3 outer tube 1143 and the space outside the No. 2 inner tube 1133 and the No. 3 inner tube 1144) becomes larger and generates negative pressure. The gas in the opening and closing balloon 1214 is extracted through the opening and closing balloon airway 1145 of the handle shell and the opening and closing balloon airway 1215 of the sheath tube, and the opening and closing balloon 1214 contracts accordingly. At this time, the opening of the balloon sheath tube 121 is in an open state, so even if the specimen volume is large, it can be guaranteed that the specimen tissue can smoothly enter the sample storage cavity 1213.

[0180] At the same time, the space in the back pressure cavity (enclosed by the No. 1 outer tube 1111, the No. 2 inner tube 1133, and the No. 3 inner tube 1144 and the No. 1 inner tube 1112) increases and generates negative pressure. External gas will enter the back pressure cavity through the pressure balance airway 1113 to ensure that the pressure reduction in the back pressure cavity will not affect the retraction of the movable ferrule 111. The process of the cryoprobe 2 retracting into the sample storage cavity 1213 through the opening and closing balloon 1214 is shown in the figure. Figure 15 shown.

[0181] In addition, after the specimen tissue enters the sample storage cavity 1213 along with the cryoprobe 2, a convex ring 1135 is provided on a specific position of the inner wall of the second outer tube 1132 of the sleeve 113, as shown in FIG5 (b). During the process of withdrawing the movable sleeve 111, the annular groove at the distal end of the first outer tube 1111 will be engaged with the convex ring 1135 on the inner wall of the second outer tube 1132 (as shown in FIG5 (b)). Figure 17 As shown), the operator gets a special hand-feeling feedback (the scale segment of the movable card sleeve 111 will also have a corresponding indication "→←" mark, as shown Figure 16 As shown), to prompt the operator that the tip of the freezing probe 2 with the specimen tissue adhered has entered the sample storage cavity 1213 and is at the front end of the scraper 122 (as shown). Figure 21 At this point, the operator can turn off the freezing to reduce the adhesion between the tip surface of the cryoprobe 2 and the specimen tissue, making it easier for the specimen tissue to be scraped off smoothly.

[0182] The movable ferrule 111 is further retracted until it reaches its maximum extension state. The specimen tissue adsorbed on the surface of the tip of the freezing probe 2 is smoothly scraped off as the tip of the freezing probe 2 passes through the hard scraper 122 , and the scraped specimen tissue remains in the sample storage cavity 1213 .

[0183] In addition, if the distance between the lesion location and the distal opening of the balloon sheath 121 is large (>4 cm), after completing steps S1, S2 and S3, during step S4, the No. 1 outer tube 1111 of the movable ferrule 111 must be completely pushed into the inner cavity of the No. 2 outer tube 1132 before the two tips of the cryoprobe can reach the lesion location, then the elastic rib 1131 will be triggered, and the elastic rib 1131 will be squeezed and contracted by the distal end of the No. 1 outer tube 1111 of the movable ferrule 111 (such as Figure 18 As shown), its port will be disengaged from the limiting groove on the inner wall of the No. 3 outer tube 1143 of the handle shell 114, so that the sleeve 113 is unlocked and can slide forward together with the movable sleeve 111 so that the cryoprobe 2 can be extended a farther distance from the distal end opening of the balloon sheath 121. At this time, the insertion depth of the cryoprobe 2 can be understood by reading the scale value on the scale segment of the sleeve 113.

[0184] Specifically, when the freezing probe 2 extends out of the sampling sheath 1, it is extended in stages. The next stage of extension is started only after the current stage is fully extended. The next stage scale value is accumulated on the basis of the previous stage scale value, and the value indicated also represents the actual length value of the freezing probe 2 extending out of the sampling sheath 1.

[0185] Specifically, when the sleeve 113 is just covering the "0" of the scale segment of the movable ferrule 111, the probe tip is just flush with the opening of the sheath (e.g. Figure 13 As shown), continue to push the movable ferrule 111 forward until the scale "4" is just covered by the sleeve 113 (that is, the movable ferrule 111 is completely pushed into the sleeve 113, as shown). Figure 18 As shown), the probe tip extends 4 cm from the distal end opening of the sheath tube. At this time, the sleeve 113 is unlocked and in the initial position, and the scale "4" on its surface is just covered by the handle housing 114, as shown. Figure 19 Therefore, the movable sleeve 111 is continuously pushed forward, and the needle insertion depth can be understood by reading the scale value on the scale section of the sleeve 113.

[0186] When the freezing and adhesion target tissue is completed and the movable ferrule is withdrawn 111 , the steps are as described in S5 .

[0187] In the above steps, each tube is kept sealed.

[0188] By rotating the air pressure adjustment knob 118 clockwise / counterclockwise, the air sealing ring 1182 is indirectly squeezed / stretched through the adjusting air sealing ring gasket 1181 to achieve the closing / opening of the inner hole of the adjusting air sealing ring 1182, thereby achieving the purpose of isolating / connecting the closed cavity with the outside world, and then allowing the gas in the closed cavity to enter and exit in a controllable manner to adjust the pressure in the closed cavity so that it is always maintained within a suitable range during the process of pushing forward and withdrawing the movable sleeve 111, so that the opening and closing balloon 1214 can always expand / contract with the pushing / withdrawing action of the movable sleeve 111, that is, the opening of the balloon sheath 121 is closed / opened.

[0189] Step S6, push the movable sleeve 111 forward again, the space of the closed cavity becomes smaller and positive pressure is generated, and the gas inside it is injected into the opening and closing balloon 1214 through the handle shell opening and closing balloon airway 1145 and the sheath opening and closing balloon airway 1215, and the opening and closing balloon 1214 expands accordingly. At this time, the opening of the balloon sheath 121 is in a closed state.

[0190] After the movable sleeve 111 drives the tip of the cryoprobe 2 to extend out of the balloon sheath 121 through the opening and closing balloon 1214, the opening and closing balloon 1214 surrounds the outside of the cryoprobe 2 (such as Figure 14As shown), the sample storage cavity 1213 is in a closed state, and the tissue specimen retained in the sample storage cavity 1213 will not be carried out of the balloon sheath 121 due to the push-out of the freezing probe 2 (the inner surface of the sample storage cavity 1213 can be roughened, such as: providing burrs or inverted teeth structures to increase the adhesion between the specimen tissue and the inner surface of the sample storage cavity 1213, further reducing the possibility of the specimen tissue being carried out of the balloon sheath 121 by the freezing probe 2).

[0191] At the same time, the space of the back pressure cavity becomes smaller and positive pressure is generated, and the excess gas inside it will be discharged through the pressure balance airway 1113 to ensure that the forward movement of the 111 movable ferrule is not affected by the pressure increase in the back pressure cavity.

[0192] The tip of the freezing probe 2 is again attached to the surface of the lesion tissue for freezing sampling.

[0193] Repeat the above steps S1 to S6 to obtain multiple specimen tissues.

[0194] Therefore, there is no need to repeatedly move the bronchoscope and the sampling sheath 1 in and out of the patient's body as a whole, causing the location of the lesion to be lost. Therefore, the situation in the bronchial cavity can be directly observed immediately after the specimen is taken out. The freezing probe 2 does not need to be repeatedly taken out of the sampling sheath 1 as a whole, but can be slightly withdrawn. This greatly shortens the sampling journey, greatly improves the biopsy efficiency, and reduces the difficulty of operation.

[0195] In addition, if the bronchial diameter is small and needs to be dilated, the balloon 1211 on the balloon sheath 121 can be used as a dilation method by inflating the balloon inlet 1141 on the handle housing 114 to dilate the bronchial diameter. At the same time, the balloon 1211 can also be used as a blocking balloon to prevent excessive bleeding during the biopsy process.

[0196] When the amount of specimen tissue pre-stored in the sample storage cavity 1213 is sufficient, the proximal buckle of the freezing probe 2 can be unlocked and the freezing probe 2 can be taken out of the working channel of the sampling sheath 1 as a whole.

[0197] Then, the connection between the distal opening of the process sleeve 115 and the entrance of the working channel of the bronchoscope is disconnected, and the 12 sheath tube units are taken out from the working channel of the bronchoscope as a whole.

[0198] Then connect the adapter fixture 117 to the proximal entrance of the movable ferrule 111, and inject physiological saline into the working channel of the sampling sheath 1 through the adapter fixture 117 to flush the specimen tissue pre-stored in the sample cavity 1213 out of the sample cavity 1213 to obtain a biopsy specimen.

[0199] The above description is merely a preferred embodiment of the present invention and does not limit the present invention in any way. Any person skilled in the art who, without departing from the scope of the present invention, makes any equivalent substitution, modification, or other changes to the technical solution and technical content disclosed in the present invention shall be deemed to be within the scope of the present invention and still fall within the scope of protection of the present invention.

Claims

1. A continuous cryobiopsy sampling sheath with an openable and closable inlet, characterized in that: include: A handle unit (11) is used to move the cryoprobe (2), comprising a telescopic unit and a process sleeve (115), wherein the proximal opening of the process sleeve (115) is clamped on the outer wall of the telescopic unit, and the distal opening thereof is connected and fixed to the working channel entrance of the bronchoscope; and a sheath unit (12), comprising: The balloon sheath (121) is a hollow flexible catheter, which comprises a balloon (1211), a sheath balloon airway (1212), a sample storage cavity (1213), an opening and closing balloon (1214), and a sheath opening and closing balloon airway (1215); from the distal end to the proximal end, the opening and closing balloon (1214), the sample storage cavity (1213), and the balloon (1211) are arranged in sequence; The sheath tube balloon airway (1212) is opened in the balloon sheath tube (121) and communicates with the handle shell balloon airway (1142) of the telescopic unit and the balloon (1211) of the sheath tube unit (12); the sheath tube opening and closing balloon airway (1215) is opened in the balloon sheath tube (121) and extends to the opening and closing balloon (1214), and communicates with the opening and closing balloon (1214) and the handle shell opening and closing balloon airway (1145) of the telescopic unit; The handle shell opening and closing balloon airway (1145) is provided on the handle shell (114) of the handle unit (11), and its proximal end is communicated with the closed cavity. The telescopic unit includes a closed cavity. The volume of the closed cavity changes as the telescopic unit expands and contracts, so that the gas in the closed cavity is injected into or withdrawn from the opening and closing balloon (1214) through the handle shell opening and closing balloon airway (1145) and the sheath tube opening and closing balloon airway (1215), and the opening and closing balloon (1214) is expanded or contracted. The opening and closing balloon (1214) is fixed to the inner wall of the distal end of the sample storage cavity (1213) and the distal opening of the balloon sheath (121); The sample storage cavity (1213) is used to pre-store the obtained tissue specimen and is connected to the working channel of the telescopic unit through the working channel of the balloon sheath (121); the balloon (1211) is arranged on the outer wall of the balloon sheath (121) and behind the sample storage cavity (1213) and is used for dilating or blocking the airway; The balloon sheath tube (121) passes through the process sleeve (115), and its proximal opening is connected and fixed to the distal opening of the handle unit (11); the working channel of the balloon sheath tube (121) is connected to the sample storage cavity (1213) and the working channel of the telescopic unit; A scraper (122) is fixed at the junction of the working channel of the balloon sheath (121) and the sample storage cavity (1213), and the freezing probe (2) can pass through the inner hole of the scraper (122) to scrape the tissue specimen from the tip surface of the freezing probe (2); and two developing rings (123), both of which are sleeved on the outer wall of the balloon sheath (121), wherein one developing ring (123) is located at the proximal end of the opening and closing balloon (1214); and the other developing ring (123) is located at the position of the scraper (122).

2. The continuous cryobiopsy sampling sheath with an openable and closable inlet according to claim 1, characterized in that: The telescopic unit comprises: a movable sleeve (111), a sleeve (113) and a handle housing (114); The movable sleeve (111) comprises a No. 1 inner tube (1112) and a No. 1 outer tube (1111); the No. 1 inner tube (1112) is a through-slot structure, which is opened in the cavity of the No. 1 outer tube (1111), and the distal end extends outside the distal end of the No. 1 outer tube (1111), and the inner cavity thereof is a working channel of the handle unit (11); The sleeve (113) comprises a No. 2 inner tube (1133) and a No. 2 outer tube (1132); the No. 2 inner tube (1133) is used to accommodate the No. 3 inner tube (1144) and the No. 1 inner tube (1112); the distal end of the No. 2 inner tube (1133) is located in the cavity of the No. 3 outer tube (1143); the No. 2 inner tube (1133) is coaxially arranged in the No. 2 outer tube (1132), and the distal end of the No. 2 inner tube 1133 is connected and fixed to the distal end of the No. 2 outer tube (1132) via a plurality of connecting ribs (1134); The distal end of the second inner tube (1133) is provided with a plurality of elastic ribs (1131) radially distributed along the circumference of the second inner tube (1133), and the elastic ribs (1131) and the connecting ribs (1134) are alternately distributed; The elastic rib (1131) extends to the outside of the distal end of the second outer tube (1132) and expands from the second inner tube (1133) to the inner wall of the third outer tube (1143); The handle housing (114) includes a No. 3 inner tube (1144) and a No. 3 outer tube (1143); the No. 3 inner tube (1144) is a through-slot structure, which is opened in the cavity of the No. 3 outer tube (1143), and its proximal end extends outside the proximal end of the No. 3 outer tube (1143); the cavity of the No. 3 outer tube (1143) coaxially surrounds the No. 3 inner tube (1144); The third outer tube (1143) is provided with a handle shell balloon airway (1142) and a handle shell opening and closing balloon airway (1145); The handle shell balloon airway (1142) has a proximal end connected to the balloon inflation port (1141), and the balloon inflation port (1141) is connected to the outside world; and a distal end connected to the sheath balloon airway (1212) of the balloon sheath (121); The handle shell opens and closes the balloon airway (1145), and its proximal end is connected to the inner cavity of the No. 3 outer tube (1143); its distal end is connected to the sheath tube opening and closing balloon airway (1215) of the balloon sheath tube (121); The first outer tube (1111), the second outer tube (1132) and the third outer tube (1143) are coaxially sleeved from the inside to the outside; the first inner tube (1112), the third inner tube (1144) and the second inner tube (1133) are coaxially sleeved from the inside to the outside; the first inner tube (1112) and the third inner tube (1144) form a working channel for accommodating the freezing probe (2); The spaces inside the No. 1 outer tube (1111), the No. 2 outer tube (1132) and the No. 3 outer tube (1143) and the spaces outside the No. 2 inner tube (1133) and the No. 3 inner tube (1144) together form the closed cavity.

3. The continuous cryobiopsy sampling sheath with an openable and closable inlet according to claim 2, characterized in that: The inner portion of the No. 1 outer tube (1111), the No. 2 inner tube (1133), and the No. 3 inner tube (1144) and the outer portion of the No. 1 inner tube (1112) together form a back pressure cavity, and the distal end of the pressure balancing airway (1113) is in communication with the back pressure cavity; the pressure balancing airway (1113) is opened in the No. 1 outer tube (1111); When the movable ferrule (111) is withdrawn, the space of the back pressure cavity becomes larger and generates negative pressure, and the external gas enters the back pressure cavity through the pressure balance airway (1113) to ensure that the withdrawal action of the movable ferrule (111) is not affected by the pressure reduction in the back pressure cavity.

4. The continuous cryobiopsy sampling sheath with an openable and closable inlet according to claim 2, characterized in that: The first outer tube (1111) and the second outer tube (1132), as well as the second outer tube (1132) and the third outer tube (1143), are sealed by the first sealing ring (1121) and the third sealing ring (1123), respectively. The No. 1 sealing ring (1121) is buckled in the distal ring groove of the No. 1 outer tube (1111), and the No. 3 sealing ring (1123) is buckled in the distal ring groove of the No. 2 outer tube (1132).

5. The continuous cryobiopsy sampling sheath with an openable and closable inlet according to claim 2, characterized in that: The first inner tube (1112) and the third inner tube (1144) as well as the third inner tube (1144) and the second inner tube (1133) are sealed by a movable ferrule sealing ring (112) and a fourth sealing ring (1124), respectively; The No. 1 outer tube (1111) and the No. 2 inner tube (1133) are sealed by the No. 2 sealing ring (1122); the movable ferrule sealing ring (112) is buckled in the distal ring groove of the No. 1 inner tube (1112), the No. 4 sealing ring (1124) is buckled in the proximal ring groove of the No. 3 inner tube (1144), and the No. 2 sealing ring (1122) is buckled in the proximal ring groove of the No. 2 inner tube (1133).

6. The continuous cryobiopsy sampling sheath with an openable and closable inlet according to claim 2, characterized in that: It further comprises an air pressure regulating mechanism for regulating the air pressure in the cavity, which comprises an air pressure regulating knob (118), an regulating air sealing ring gasket (1181) and an regulating air sealing ring (1182); A hollow adjustment column is fixed on the outer wall of the third outer tube (1143), and an adjustment channel connected to the cavity of the third outer tube (1143) is formed in the adjustment column; an adjustment air sealing ring gasket (1181) and an adjustment air sealing ring (1182) are placed in the adjustment channel in sequence, and the adjustment air sealing ring (1182) is arranged close to the third outer tube (1143).

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