A bronchial spray freezing system

Abstract

The present invention discloses a bronchial spray freezing system, comprising a tube body, a spray head, a baffle, and a cold source device, wherein the cold source device, the tube body, and the spray head are connected in sequence; wherein the spray head comprises a plurality of spray ports and a head end, wherein the spray ports are evenly distributed in a circumferential shape in the middle of the spray head, and the baffle is located between the spray port and the head end; wherein the baffle coated on the surface of the spray head can be unfolded to achieve distal blocking. The baffle is a circumferential flexible material, and is S-shaped or arc-shaped along the axial cross section of the vacuum tube. The cold source fluid or the pushing device ejected from the spray port causes the baffle to form an unfolded shape to achieve a flow blocking effect. Therefore, the bronchial spray freezing system is provided with a baffle at the distal end of the spray port, and while achieving distal blocking, adaptive adjustments can be made to blocking areas of different sizes at the same time, achieving blocking effects of blocking areas of different sizes, and providing a safe and convenient means for treating airway hyperreactivity or chronic bronchitis.

Description

Technical Field

[0001] The invention relates to the field of spray cryoablation, and in particular to a bronchial spray cryoablation system. Background Art

[0002] The conventional methods for treating airway hyperresponsiveness or chronic bronchitis include the use of systemic corticosteroids or inhaled corticosteroids, anticholinergic drugs, antibiotics, bronchodilators, short-acting / long-acting β2 receptor agonists that relax airway smooth muscle, aerosol delivery agents (high concentration saline), and oral expectorants such as roflumilast. However, except for roflumilast and PDE-4, the other drugs are not specific for COPD treatment, and the above drugs also have serious side effects. Inhaled corticosteroids can cause thursh (caused by yeast infection in the mouth), cough, and hoarseness, and systemic corticosteroids can even cause delayed libido, irregular menstruation, weight gain, and increased blood sugar. The side effects of acetylcholine include severe nausea, tremor, muscle spasm, epileptic seizures, and arrhythmias. Roflumilast usually causes severe diarrhea. Therefore, patients have poor compliance with the above treatment methods.

[0003] Interventional treatments include surgery, mechanical ventilation, brachytherapy, stents, photodynamic therapy, thermal therapy such as electrocautery, laser, APC, and bronchial thermoplasty (BT). Bronchial thermoplasty uses heat to coagulate and necrotize hyperplastic smooth muscle cells, ultimately reducing the airway smooth muscle layer and partially reversing airway structural remodeling. BT-treated tissues will form scars and fibrosis. High heat treatment denatures proteins, inactivates enzymes, and inhibits collagen remodeling. In addition, BT-treated areas cannot be treated a second time. Cryoprobes are clumsy and time-consuming to use.

[0004] Spray cryotherapy is a traditional and novel treatment method, which uses a low-temperature cold source to directly contact the tissue, so that the contacted tissue quickly drops to an extremely low temperature to kill cells. The bronchial spray cryotherapy system is a device for transporting a low-temperature cold source to the target area and releasing it. However, when releasing the cold source medium, the cold source often extends to the farther distal end of the bronchus. The distal area is relatively weak and more easily damaged by the low-temperature cold source material, so blocking measures are adopted at the distal end. In the existing products in the field of spray cryoablation, most of the distal blocking uses an inflatable balloon structure, which is placed at the distal end of the treatment area to achieve the effect of distal blocking. However, the balloon blocking method is more complicated to operate, and the selection of the balloon size is cumbersome and risky, because each different blocking area requires the selection of a different size of blocking balloon, and if the balloon size is too small, the blocking effect is poor, and if the balloon is too large, it is easy to cause squeezing damage to the tube wall at the blocking site. Summary of the invention

[0005] The present invention proposes a bronchial spray freezing system to solve the above-mentioned problems in the prior art. A baffle is arranged at the distal end of the spray port to achieve distal blocking and adaptively adjust blocking areas of different sizes at the same time to achieve blocking effects of blocking areas of different sizes.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] The first aspect of the present invention is to provide a bronchial spray freezing system, which includes a tube body, a spray head, a baffle, and a cold source device, wherein the cold source device, the tube body and the spray head are connected in sequence; wherein the spray head includes a plurality of spray nozzles and a head end, the spray nozzles are evenly distributed in a circular shape in the middle of the spray head, and the baffle is located between the spray nozzle and the head end; wherein the baffle coated on the surface of the spray head can be unfolded to achieve distal blocking.

[0008] Furthermore, the spray port includes spray holes arranged in a circumferential manner on the spray head tube body.

[0009] Furthermore, the tube body includes an air inlet pipe and a vacuum tube. The air inlet pipe is inside the vacuum tube, and there is a gap between the two, and the gap is a vacuum layer. The air inlet pipe is connected to the cold source device through an air inlet joint, and the vacuum tube is connected to the cold source device through a vacuum joint. The air inlet joint, the air inlet pipe and the spray head are connected to form a passage, and the cold source fluid enters from the air inlet joint and is sprayed out from the spray port.

[0010] Furthermore, the spoiler is deployed by cold air or by a device, that is, the spoiler is blown to the deployed state by the force of the cold source fluid discharged from the spray port or the spoiler is deployed and retracted by a pushing device.

[0011] Furthermore, in the cold air-propelled deployment mode, a traction wire is provided or not provided at the edge of the baffle; the traction wire is connected to the distal end of the vacuum tube or to the proximal end of the spray head or the traction wire is connected to the gap between the proximal end of the spray head and the vacuum tube.

[0012] Furthermore, the baffle without a traction wire at the edge is made of a circumferentially flexible material, and has an inwardly concave S-shape, an outwardly concave S-shape, or an inwardly concave arc shape, an outwardly concave arc shape along the axial section of the vacuum tube.

[0013] Furthermore, different parts of the spoiler have different thicknesses; wherein the connection part, the proximal corner and the distal corner are thickened.

[0014] Furthermore, the baffle with the traction wire arranged on the edge is made of a circumferentially flexible material and has an inwardly concave S-shape in the axial cross section of the vacuum tube.

[0015] Furthermore, a reinforcing wire is attached to the inner surface of the spoiler to improve the strength of the spoiler.

[0016] Furthermore, in the device pushing and deployment mode, the bronchial spray freezing system also includes a pushing device, the pushing device includes an outer sheath tube, the outer sheath tube includes an outer sheath tube body and an outer sheath tube handle, the outer sheath tube body includes a guide rail groove; the vacuum tube is provided with a scale groove, a limit pin and a guide rail; the guide rail moves in the guide rail groove.

[0017] Furthermore, the outer sheath handle includes a scale pin and a spring device, and the tip of the scale pin fits in the scale groove; when the outer sheath moves, the scale pin moves in the scale groove, and the limit pin can limit the expansion size of the baffle.

[0018] Furthermore, in the device push-and-expand mode, a reinforcing wire is attached to the inner surface of the spoiler to cooperate with the pushing device.

[0019] Furthermore, in the device pushing and deploying mode, the pushing device may further include a supporting device, and the distal end of the outer sheath is connected to the baffle through the supporting device.

[0020] Furthermore, the supporting device is not limited to a supporting rod or a supporting wire.

[0021] The present invention adopts the above technical solution, which has the following technical effects compared with the prior art:

[0022] 1. A circumferential flexible baffle is arranged at the far end of the spray port. The circumferential shape can achieve the maximum blocking area, and the flexible baffle will not damage the human tissue when it contacts the human tissue during the movement of the tube body.

[0023] 2. The spoiler has an S-shaped or arc-shaped cross section along the axial direction of the vacuum tube. This shape can automatically adjust the expansion degree at blockages of different sizes, so that the same spoiler can adapt to blockages of different sizes and shapes.

[0024] 3. The spoiler can use the fluid sprayed from the spray port to form the spoiler into an expanded shape, making full use of the physical effect of the fluid sprayed from the spray port to achieve automatic expansion of the spoiler, which is simple and convenient to operate.

[0025] 4. Traction wires are arranged around the spoiler, and the traction wires are connected to the distal end of the outer sheath. This design can prevent the spoiler from being over-expanded and can better expand the spoiler to an ideal shape.

[0026] 5. The spoiler is covered with a support net, which has a certain rigidity and flexibility, so that the spoiler can maintain a good shape in both the contracted and expanded states. The expansion and contraction of the spoiler is completed by the outer sheath tube, which can be achieved by moving the outer sheath tube, without the need for other auxiliary devices, and the operation is simple and convenient.

[0027] In summary, the bronchial spray freezing system provided by the present invention is provided with a baffle at the distal end of the spray outlet, which can realize distal blocking and adaptively adjust blocking areas of different sizes at the same time, thereby achieving blocking effects of blocking areas of different sizes, providing a safe and convenient means for treating airway hyperresponsiveness or chronic bronchitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A simplified structural diagram of a bronchial spray freezing system of the present invention;

[0029] Figure 2 is a cross-sectional view of a tube body in a bronchial spray freezing system of the present invention;

[0030] Figure 3 It is a schematic diagram of the structure of the spoiler in the present invention;

[0031] Figure 4 It is a schematic diagram of the structure of a spoiler in one embodiment of the present invention;

[0032] Figure 5 It is a schematic diagram of the structure of a spoiler in one embodiment of the present invention;

[0033] Figure 6 It is a schematic diagram of the structure of a spoiler in one embodiment of the present invention;

[0034] Figure 7 It is a schematic diagram of the structure of a spoiler in one embodiment of the present invention;

[0035] Figure 8 A cross-sectional view of an embodiment of the present invention in which the spoiler is S-shaped along the axial direction of the vacuum tube;

[0036] Fig. 9 It is a cross-sectional view of an embodiment of the present invention in which the baffle is in an arc shape along the axial section of the vacuum tube;

[0037] Fig.10 A schematic diagram of a structure of a cold air driven deployment method in one embodiment of the present invention;

[0038] Fig.11 It is another structural schematic diagram of the cold air driven deployment method in one embodiment of the present invention;

[0039] Fig.12 A schematic diagram of a fixing method of a traction wire in an embodiment of the present invention;

[0040] Fig.13 It is a schematic diagram of the structure in which a spoiler is attached to a reinforcing wire in one embodiment of the present invention;

[0041] Fig.14 This is a schematic diagram of the assembly of the outer sheath tube in one embodiment of the present invention;

[0042] Fig.15 This is a schematic diagram of the overall structure of the outer sheath tube in one embodiment of the present invention;

[0043] Fig.16 It is a structural schematic diagram of a cross-sectional view of an outer sheath handle in one embodiment of the present invention;

[0044] Fig.17 is a cross-sectional view of an outer sheath tube in one embodiment of the present invention;

[0045] Fig.18 It is a schematic diagram of a first preferred structure of a pushing device in one embodiment of the present invention;

[0046] Fig.19 It is a schematic diagram of a second preferred structure of a pushing device in one embodiment of the present invention;

[0047] Fig. 20 It is a schematic diagram of a third preferred structure of a pushing device in one embodiment of the present invention;

[0048] Fig.21 It is a general schematic diagram of a preferred structure in which the outer sheath tube has a distal end of the outer sheath tube in one embodiment of the present invention;

[0049] Fig. 22 for Fig.21 A schematic diagram of the structure of the distal end of the outer sheath tube;

[0050] Fig.23 A general schematic diagram of another preferred structure of the outer sheath tube at the distal end of the outer sheath tube in one embodiment of the present invention;

[0051] Fig.24 for Fig.23 A schematic diagram of the structure of the distal end of the outer sheath tube;

[0052] Among them, 1-tube body; 11-air inlet pipe; 12-vacuum tube; 121-scale groove; 122-limit pin; 123-guide rail; 2-spray head; 21-spray outlet; 22-head end; 3-blocking plate; 31-support device; 32-traction wire; 33-reinforcement wire; 4-air inlet connector; 5-vacuum connector; 6-outer sheath; 61-outer sheath body; 611-guide groove; 62-outer sheath handle; 621-scale pin; 622-spring device; 63-connecting buckle; 64-distal end of outer sheath; 641-incision; 642-outer sheath head end. DETAILED DESCRIPTION

[0053] The present invention provides a bronchial spray freezing system, referring to Figure 1 and Figure 2The invention comprises a tube body 1, a spray head 2, a baffle 3, and a cold source device 7. The distal end of the tube body 1 is connected to the proximal end of the spray head 2, the proximal end of the tube body 1 is connected to the cold source device 7, and the baffle 3 is connected to the distal end of the spray head 2. The tube body 1 comprises an air inlet pipe 11 and a vacuum tube 12. The air inlet pipe 11 is inside the vacuum tube 12, and there is a gap between the two. The gap is a vacuum layer, which realizes the function of a heat insulation layer.

[0054] The bronchial spray freezing system also includes an air inlet connector 4 and a vacuum connector 5; an air inlet pipe 11 is connected to the air inlet connector 4, a vacuum tube 12 is connected to the vacuum connector 5, and the distal end of the vacuum tube 12 is covered at the proximal end of the spray head 2. The spray head 2 includes a spray port 21 and a head end 22, and the spray port 21 includes a plurality of spray holes. The air inlet pipe 11, the air inlet connector 4 and the spray head 2 are connected to form a passage, and the cold source fluid enters from the air inlet connector 4 and is sprayed out from the spray port 21.

[0055] The spoiler 3 is made of a circumferentially flexible material, and has an S-shaped or arc-shaped cross section along the axial direction of the vacuum tube 12. The spoiler 3 is deployed by cold air pushing or by a device pushing, that is, the spoiler 3 is blown to the deployed state by the force of the cold source fluid discharged from the spray port 21, or the spoiler is deployed and retracted by a pushing device.

[0056] refer to Figure 14-17 In the device push deployment mode, the bronchial spray freezing system also includes a push device, which includes an outer sheath tube 6, and the outer sheath tube 6 includes an outer sheath tube body 61 and an outer sheath tube handle 62, and the outer sheath tube body 61 includes a guide groove 611; the vacuum tube 12 is provided with a scale groove 121, a limit pin 122 and a guide rail 123; the guide rail 123 moves in the guide groove 611. The outer sheath tube handle 62 includes a scale pin 621 and a spring device 622, and the tip of the scale pin 621 fits the scale groove 121; when the outer sheath tube 6 moves, the scale pin 621 moves in the scale groove 121, and the limit pin 122 can limit the expansion size of the baffle 3. In the device push deployment mode, a reinforcing wire 33 is attached to the inner surface of the baffle 3 to cooperate with the push device so that the baffle has a certain rigidity.

[0057] When the system is in working state, the spoiler is unfolded. The push of the outer sheath can control the unfolding size of the spoiler. There are guide rails inside the outer sheath and on the surface of the tube body, so that the outer sheath can only move to the distal or proximal end relative to the tube body, and will not rotate or offset. There is a limit slot inside the outer sheath to limit the degree of movement of the outer sheath and prevent the spoiler from over-expanding or over-contracting.

[0058] The present invention is described in detail and specifically by specific examples below to provide a better understanding of the present invention, but the following examples do not limit the scope of the present invention.

[0059] Embodiment 1

[0060] This embodiment combines the attached Figure 3-13 The preferred structure of the spoiler 3 deployed by the cold source gas sprayed through the spray port 21 is described.

[0061] Depend on Figure 3 It can be seen that the baffle 3 is located between the spray port 21 and the head end 22. When the spray port 21 does not spray the cold source fluid, it covers the surface of the spray head 2. When the spray port 21 sprays the cold source, the power of the cold source fluid is used to blow the baffle 3 to the expanded state.

[0062] 1. As Figure 4-Figure 7 As shown, the spoiler 3 is in an inwardly concave S-shape, outwardly concave S-shape, inwardly concave arc shape and outwardly concave arc shape along the axial section of the vacuum tube. The spoiler 3 is in an S-shape or arc shape along the axial section of the vacuum tube. This shape can automatically adjust the expansion degree at blocking places of different sizes, so that the same spoiler can adapt to blocking places of different sizes and shapes.

[0063] like Figure 8-9 As shown, the thickness of the spoiler 3 is set to different thicknesses according to different parts. The connection 34, the proximal corner 35 and the distal corner 36 are thickened. The spoiler 3 is thicker at the connection, with high strength and not easy to tear and deform, and the thickness at the unfolding part makes the spoiler easier to unfold; the spoiler 3 is thicker at the S-shaped or arc-shaped corner, so that the spoiler 3 is easier to shape and easier to achieve an ideal unfolding mode when unfolded.

[0064] 2. If Fig.10 As shown, a traction wire 32 is arranged at the edge of the spoiler 3, and the cross section along the axial direction of the vacuum tube is S-shaped. The traction wire 32 is a soft traction wire, but has a certain rigidity. When the spoiler 3 is not expanded, it covers the spray head 2 with the spoiler 3; when the spoiler 3 is expanded, the traction wire 32 is stretched first, which can limit the spoiler 3 and prevent the spoiler 3 from being deformed due to excessive pressure. The preferred structure of the spoiler 3 provided with the traction wire 32 is provided below.

[0065] like Fig.10 As shown, the traction wire 32 is connected to the distal end of the vacuum tube 12 or to the proximal end of the spray head 2 or the traction wire 32 is connected to the gap between the proximal end of the spray head 2 and the vacuum tube.

[0066] like Fig.11 As shown, increasing the number of traction wires 32 can provide greater traction force and make the traction force distribution more uniform.

[0067] like Fig.12 As shown, the traction wire 32 is fixed to the edge of the spoiler 3 in an isosceles triangle fixing manner at the portion close to the spoiler 3, so that the fixation is more firm.

[0068] like Fig.13As shown, the inner surface of the spoiler 3 is attached with a reinforcing wire 33 , which has a certain rigidity and toughness, and can improve the strength of the spoiler and make it easier to unfold to an ideal shape.

[0069] Embodiment 2

[0070] refer to Figure 18-Figure 20 This embodiment provides three preferred structures of the pushing device in the device pushing and unfolding mode.

[0071] 1.Reference Fig.18 The push device includes an outer sheath distal end 64, which includes an incision 641 and a head end 642. The spray port 21 is inside the incision 641 and does not block the ejection of the cold source. The spoiler 3 is directly pushed open by the head end 642 of the outer sheath to achieve its deployment, and the spoiler 3 will also be retracted when the outer sheath is recovered.

[0072] 2.Reference Fig.19 The pushing device includes an outer sheath distal end 64 and a supporting device 31, which includes but is not limited to a supporting rod and a supporting wire, and the outer sheath distal end 64 is connected to the spoiler 3 through the supporting device 31. The spoiler 3 is expanded or contracted by the combined action of the outer sheath distal end 642 and the supporting device 31.

[0073] 3.Reference Fig. 20 The pushing device includes a supporting device 31, which includes but is not limited to a supporting rod and a supporting wire, and the distal end of the outer sheath tube 6 is connected to the spoiler 3 through the supporting device 31. The expansion and contraction of the spoiler 3 are achieved by pushing and closing the supporting device 31.

[0074] Embodiment 3

[0075] This embodiment provides a preferred structure in which the outer sheath tube in Embodiment 2 exists at the distal end of the outer sheath tube.

[0076] 1.Reference Fig.21 and Fig. 22 The outer sheath tube 6 further includes a connecting buckle 63, and the outer sheath tube body 61 is connected to the outer sheath tube distal end 64 through the connecting buckle 63. The setting of the connecting buckle 63 can realize the disassembly of the outer sheath tube.

[0077] 2.Reference Fig.23 and Fig.24 The outer sheath tube body 61 and the outer sheath tube distal end 64 are integrated, and there is no connecting buckle in the middle.

[0078] In summary, the spoiler is deployed through a push device, and the deployment process is easier to control. A cutout is provided at the far end of the outer sheath tube corresponding to the nozzle, which will not affect the spray effect. There is a reinforcing wire on the spoiler to give the spoiler a certain rigidity. A scale device and a limit pin are also provided in the outer sheath tube, which is simple and convenient to operate.

[0079] It can be seen from the above embodiments that a bronchial spray freezing system of the present invention is provided with a baffle at the distal end of the spray port, which can realize distal blocking and at the same time make adaptive adjustments to blocking areas of different sizes to achieve blocking effects of blocking areas of different sizes.

[0080] The specific embodiments of the present invention are described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions made to the present invention are also within the scope of the present invention. Therefore, the equalization changes and modifications made without departing from the spirit and scope of the present invention should be included in the scope of the present invention.

Claims

1. A bronchial spray freezing system, characterized in that: The invention comprises a tube body (1), a spray head (2), a baffle (3), and a cold source device (7), wherein the cold source device (7), the tube body (1), and the spray head (2) are connected in sequence; wherein the spray head (2) comprises a plurality of spray ports (21) and a head end (22), wherein the spray ports (21) are evenly distributed in a circular shape in the middle of the spray head (2), and the baffle (3) is located between the spray ports (21) and the head end (22); wherein the baffle (3) coated on the surface of the spray head (2) can be unfolded to achieve far-end blocking; the tube body (1) comprises an air inlet pipe (11) and a vacuum pipe (12), wherein the air inlet pipe (11) is inside the vacuum pipe (12), and there is a gap between the two, wherein the gap is a vacuum layer; The deployment method is: a device push deployment method, in which the spoiler (3) is deployed and retracted by a pushing device; A traction wire (32) is arranged at the edge of the spoiler (3); the spoiler (3) is made of a circumferentially flexible material and has an inwardly concave S-shaped cross section along the axial direction of the vacuum tube (12); a reinforcing wire (33) is attached to the inner surface of the spoiler (3) to improve the strength of the spoiler (3); The baffle (3) has different thicknesses at different locations; wherein the connection (34), the proximal corner (35), and the distal corner (36) are thickened.

2. The bronchial spray freezing system according to claim 1, characterized in that: The air intake pipe (11) is connected to the cold source device (7) via an air intake joint (4), and the vacuum pipe (12) is connected to the cold source device (7) via a vacuum joint (5); the air intake joint (4), the air intake pipe (11) and the spray head (2) are connected to form a passage, and the cold source fluid enters from the air intake joint (4) and is sprayed out from the spray port (21).

3. The bronchial spray freezing system according to claim 1, characterized in that: The traction wire (32) is connected to the distal end of the vacuum tube (12) or is connected to the proximal end of the spray head (2), or the traction wire (32) is connected to the gap between the proximal end of the spray head (2) and the vacuum tube (12).

4. The bronchial spray freezing system according to claim 1, characterized in that: In the device pushing and deploying mode, the bronchial spray freezing system further comprises a pushing device, the pushing device comprises an outer sheath tube (6), the outer sheath tube (6) comprises an outer sheath tube body (61) and an outer sheath tube handle (62), the outer sheath tube body (61) comprises a guide rail groove (611); the vacuum tube (12) is provided with a scale groove (121), a limit pin (122) and a guide rail (123); the guide rail (123) moves in the guide rail groove (611).

5. The bronchial spray freezing system according to claim 4, characterized in that: The outer sheath tube handle (62) comprises a scale pin (621) and a spring device (622), and the tip of the scale pin (621) fits in the scale groove (121); when the outer sheath tube (6) moves, the scale pin (621) moves in the scale groove (121), and the limit pin (122) can limit the unfolding size of the spoiler (3).

6. The bronchial spray freezing system according to claim 4, characterized in that: In the pushing and unfolding mode of the device, a reinforcing wire (33) is attached to the inner surface of the spoiler (3) to cooperate with the pushing device.

7. The bronchial spray freezing system according to any one of claims 4 to 6, characterized in that: In the device pushing and deploying mode, the pushing device further comprises a supporting device (31), and the distal end of the outer sheath tube (6) is connected to the baffle (3) via the supporting device (31).

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