Tracheal / Esophageal Device and System

Abstract

The present application relates to a trachea / oesophagus device and a trachea / oesophagus system, the trachea / oesophagus device comprising a first blocking disc, a waist part and a second blocking disc, one end of the waist part being connected to the first blocking disc, the other end of the waist part being connected to the second blocking disc, the first blocking disc comprising a blocking member and at least two first supporting members extending in a first direction, the two first supporting members being arranged at intervals on the blocking member, the first blocking disc further comprising a second supporting member extending in a second direction, the first supporting member and the second supporting member being used to naturally unfold the blocking member. The trachea / oesophagus device provided by the present application, the first blocking disc of which comprises a blocking member and at least two first supporting members extending in a first direction, the two first supporting members being arranged at intervals on the blocking member, and a second supporting member extending in a second direction, wherein the first supporting member and the second supporting member cooperate to facilitate the natural unfolding of the blocking member, thereby achieving the blocking of the trachea / oesophagus fistula.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a tracheal / esophageal device and system. BACKGROUND

[0002] Tracheoesophageal fistula refers to a disease caused by various factors leading to abnormal communication between the trachea and esophagus, which is divided into two types of congenital and acquired. Tracheoesophageal fistula is more common in patients with airway malignant tumors, lung cancer, trauma, esophageal foreign bodies, tracheal intubation, etc. It can lead to tracheoesophageal communication, often causing serious and difficult-to-cure lung complications such as aspiration pneumonia, etc. In severe cases, patients cannot eat orally, which seriously reduces the quality of life of patients. Moreover, since the tracheal membrane part is elastic fiber, it is difficult to heal once damaged, which is one of the reasons why it is difficult to treat after tracheoesophageal fistula occurs.

[0003] The treatment principle of tracheoesophageal fistula is to determine the location of the fistula, restore the continuity of the esophagus, prevent and control infection, perform abscess drainage, and ensure adequate nutritional supply. At present, surgical operation is the most important way to treat tracheoesophageal fistula (TEF), but a series of complications such as chest infection, bleeding, and stent slipping often occur after operation, among which the treatment of recurrent esophageal tracheal fistula is particularly difficult. In recent years, there have been studies using atrial / ventricular septal occluder to successfully occlude esophageal tracheal fistula. However, the existing occluder is due to its own weight, and the occluder is pressed against the surrounding tissue, causing ischemic necrosis and even occluder shedding, blocking the airway and causing death. At the same time, due to the limitation of the structure of the occluder itself, and when occluding, the occluder cannot well adapt to the shape of the tracheal esophageal wall, resulting in the existence of gaps at the fistula, which is easy to cause gas leakage, leading to surgical failure. And when the occluder combines with the surrounding tissue, it is not firm, causing the fistula position to have permeable liquid, which is easy to cause repeated fever and cough symptoms.

[0004] In summary, providing a tracheal / esophageal device with good adaptability and good wall adhesion becomes one of the problems to be solved in treating tracheoesophageal fistula at the present stage. SUMMARY

[0005] One of the technical problems solved by the present application is to provide a tracheal / esophageal device with good adaptability and good wall adhesion.

[0006] The application provides a trachea / oesophagus device, which comprises a first blocking disc, a waist part and a second blocking disc, one end of the waist part is connected to the first blocking disc, the other end of the waist part is connected to the second blocking disc, the first blocking disc comprises a blocking piece and at least two first support pieces extending in a first direction, the two first support pieces are arranged at the blocking piece in a spaced manner, the first blocking disc further comprises a second support piece extending in a second direction, and the first support piece and the second support piece are used for naturally unfolding the blocking piece.

[0007] In one of the embodiments, an included angle between the first direction and the second direction is defined as α, and α satisfies 75°≤α≤90°.

[0008] In one of the embodiments, the first support piece is arranged as a support rod, and the first support piece is arranged on the side of the blocking piece close to the second blocking disc; and the second support piece is arranged as a wave structure, and the second support piece is arranged on the side of the blocking piece away from the second blocking disc.

[0009] In one of the embodiments, the plurality of support rods are arranged in a spaced manner, the width of any support rod is defined as W, W satisfies 0.8mm≤W≤1.5mm, the interval distance between any two adjacent support rods is defined as L, and L satisfies 3.5mm≤L≤4.5mm.

[0010] In one of the embodiments, the first blocking disc comprises a central axis, the central axis passes through the geometric center of the blocking piece, and the number of the second support pieces is at least one, and any single second support piece does not cross the central axis.

[0011] In one of the embodiments, the projection of the second support piece and the most edge first support piece on the blocking piece at least partially overlaps.

[0012] In one of the embodiments, any two first support pieces are crossed by the second support piece at least once.

[0013] In one of the embodiments, the second blocking disc comprises a double-layer woven wire mesh disc, the two ends of the waist part are in an open structure, the woven wire of the second blocking disc is gathered in the opening of one end of the waist part close to the end of the first blocking disc, and the trachea / oesophagus device further comprises a connecting piece, one end of the connecting piece is arranged in the opening of the other end of the waist part, the end of the connecting piece away from the second blocking disc penetrates through the first blocking disc, and the other end of the connecting piece penetrating through the first blocking disc is provided with a connecting part.

[0014] In one of the embodiments, the connecting piece comprises a communication groove, which is in the same direction as the first support and is arranged on the side of the connecting piece close to the second blocking disc, and at least one of the first supports passes through the communication groove.

[0015] The present application also provides a trachea / esophagus system, which comprises a delivery device and a trachea / esophagus device as described above, the delivery device comprises a delivery cable and a sheath, the sheath surrounds the delivery cable, the distal end of the delivery cable is detachably connected to the end of the proximal end of the first blocking disc away from the second blocking disc, and after rolling up or stacking the first blocking disc along the direction perpendicular to the first support, the first support is folded in half, so as to bundle the first blocking disc in the sheath.

[0016] One of the technical effects of one of the embodiments of the present application is to provide a trachea / esophagus device, the first blocking disc of which comprises a blocking piece and at least two first supports extending in a first direction, and the two first supports are arranged at intervals on the blocking piece, and a second support extending in a second direction, wherein the first support and the second support cooperate to facilitate the natural unfolding of the blocking piece, so as to achieve the blocking of the trachea esophagus fistula. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 The structure schematic diagram of the trachea / esophagus device provided in one of the embodiments of the present application;

[0018] Figure 2 The structure schematic diagram of the waist and the connecting piece provided in one of the embodiments of the present application;

[0019] Figure 3 For Figure 2 The sectional view in the direction of A-A;

[0020] Figure 4 The structure schematic diagram of the first blocking disc provided in one of the embodiments of the present application;

[0021] Figure 5 The plan view of the first face of the first blocking disc provided in one of the embodiments of the present application;

[0022] Figure 6 The structure schematic diagram of the first blocking disc in another direction provided in one of the embodiments of the present application;

[0023] Figure 7 The plan view of the second face of the first blocking disc provided in one of the embodiments of the present application;

[0024] Figure 8 For Figure 5 The schematic diagram of the second face in perspective view;

[0025] Figure 9 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0026] Figure 10 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0027] Figure 11 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application; Figure 2 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0028] Figure 12 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0029] Figure 13 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0030] Figure 14 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application;

[0031] Figure 15 schematic view of the first face of the first blocking disc (perspective view of the second face of the second support member) in another embodiment of the present application.

[0032] 10, trachea / esophagus device; 11, first blocking disc; 111, blocking member; 111a, first face; 111b, second face; 1111, perforation; 112, first support member; 1121, first support rod; 1122, second support rod; 1123, intermediate support rod; 113, second support member; 113a, first wave structure; 113b, second wave structure; 1131, first end; 1132, second end; 1133, third end; 1134, fourth end; 12, waist portion; 121, proximal end opening; 122, distal end opening; 13, second blocking disc; 14, connecting member; 141, connecting portion; 142, intermediate portion; 1421, communication groove; 143, embedding portion;

[0033] 100, trachea / esophagus system; 20, delivery device; 21, delivery cable; 22, sheath. DETAILED DESCRIPTION

[0034] For the purpose of promoting an understanding of the principles of the application, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will, nevertheless, be understood that no limitation of the scope of the application is thereby intended, any alterations and further modifications in the illustrated embodiments, and any further applications of the principles of the application as illustrated therein are contemplated as falling within the scope of the application.

[0035] It should be understood that when an element as a "fixed" to another element, it can be directly on the other element or there can be an intervening element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there can be an intervening element. The terms "inner," "outer," "left," "right," and similar terms are used in this context with respect to the apparatuses and methods described herein for purposes of illustration only and are not intended to be limiting.

[0036] "Axial" generally refers to the lengthwise direction of the medical device when being delivered, and "radial" generally refers to the direction perpendicular to the "axial" direction of the medical device, and the "axial" and "radial" directions of any component of the medical device are defined accordingly. In the field of interventional medical devices, the end closer to the operator is defined as the "proximal end" and the end further away from the operator is defined as the "distal end" for the delivery device that delivers the medical device into the human or animal body, and the "proximal end" and "distal end" of any component of the delivery device are defined accordingly.

[0037] The present application provides a tracheal / esophageal device 10, as shown in Figures 1-15 The tracheal / esophageal device 10 includes a first occlusion disc 11, a waist portion 12, and a second occlusion disc 13, one end of the waist portion 12 is connected to the first occlusion disc 11, the other end of the waist portion 12 is connected to the second occlusion disc 13, the waist portion 12 can be directly connected to the first occlusion disc 11, or indirectly connected to the first occlusion disc 11 through a connecting piece 14, thereby connecting the first occlusion disc 11 and the second occlusion disc 13 into a whole tracheal / esophageal device 10.

[0038] In one embodiment, as shown in Figure 1 and Figures 4-8 The tracheal / esophageal device 10 includes a first occlusion disc 11, a waist portion 12, and a second occlusion disc 13, one end of the waist portion 12 is connected to the first occlusion disc 11, the other end of the waist portion 12 is connected to the second occlusion disc 13, the waist portion 12 can be directly connected to the first occlusion disc 11, or indirectly connected to the first occlusion disc 11 through a connecting piece 14, thereby connecting the first occlusion disc 11 and the second occlusion disc 13 into a whole tracheal / esophageal device 10.

[0039] In one embodiment, as shown in Figures 2-3As shown, the two ends of the waist portion 12 are open structures for connecting the first sealing disc 11 and the second sealing disc 13. The trachea / esophagus device 10 further comprises a connecting member 14. The second sealing disc 13 comprises a double-layer woven wire mesh disc. The woven wires of the second sealing disc 13 are bundled at the end of the first sealing disc and inserted into the opening at one end of the waist portion 12. One end of the connecting member 14 is inserted into the opening at the other end of the waist portion 12. The end of the connecting member 14 away from the second sealing disc passes through the first sealing disc 11. The end of the connecting member 14 passing through the first sealing disc 11 is provided with a connecting portion 141. The first sealing disc 11 and the second sealing disc 13 are indirectly connected into a whole through the connecting member 14. The connecting portion 141 of the connecting member 14 can be used to connect with the delivery steel cable 21 of the delivery device 20, so as to bundle the trachea / esophagus device 10 into the sheath tube 22 of the delivery device 20.

[0040] In one embodiment, as shown in Figure 11 In combination Figure 3 As shown, the proximal end opening 121 of the waist portion 12 is used to connect the first sealing disc 11, and the distal end opening 122 of the waist portion 12 is used to connect the second sealing disc 13. The proximal end opening 121 of the waist portion 12 is connected with the distal end of the connecting member 14. The distal end of the connecting member 14 is embedded into the proximal end opening 121 of the waist portion 12, and the waist portion 12 and the connecting member 14 are further welded together to ensure the reliability of the connection.

[0041] In one embodiment, as shown in Figures 4-8 As shown, the first sealing disc 11 comprises a sealing member 111, a plurality of first support members 112 extending in a first direction, and a plurality of second support members 113 extending in a second direction. The first support members 112 and the second support members 113 are respectively arranged on different sides of the sealing member 111. The sealing member 111 is arranged as a sealing film layer. The sealing film layer can be made of polytetrafluoroethylene (PTFE) film. The sealing member 111 comprises a first surface 111a and a second surface 111b. The first surface 111a is the side of the sealing member 111 close to the second sealing disc 13, and the second surface 111b is the side of the sealing member 111 away from the second sealing disc 13. A plurality of first support members 112 are arranged on the first surface 111a in the first direction. The first support member 112 comprises a support rod. In one embodiment, the first support member is arranged as a support rod, and the support rod extends in the first direction. When the bundled first sealing disc 11 is released from the sheath tube 22, the first support member 112 facilitates the expansion of the sealing member 111 in the first direction. The material of the support rod can be selected from self-expandable materials such as nickel-titanium alloy wire or nickel-titanium alloy rod. The first support member 112 is arranged on the side of the sealing member 111 close to the second sealing disc 13, so that the plurality of spaced support rods can be clamped into the membrane part between the inner walls of the trachea, and the cartilage rings of the inner walls of the trachea can be embedded into the space between the adjacent support rods, so that the first sealing disc 11 can better adhere to the inner walls of the trachea.

[0042] The second support 113 is arranged on the side of the occlusion member 111 away from the second occlusion disc 13, and the second support 113 is arranged on the second surface 111b in the second direction. The second support 113 comprises a wave structure. In one embodiment, the second support is arranged in a wave structure, and the wave structure extends in the second direction. When the first occlusion disc 11 is released from the sheath 22, the second support 113 facilitates the expansion of the occlusion member 111 in the second direction. The angle between the first direction and the second direction is defined as α, and α satisfies 75°≤α≤90°, so that the first support 112 and the second support 113 can expand the entire occlusion member 111 in the circumferential direction. When the tracheal / esophageal device 10 is released from the sheath 22, the first support 112 and the second support 113 can expand the entire disc surface of the first occlusion disc 11, so as to be attached to the stoma of the tracheoesophageal fistula. The wave structure is a sinusoidal wave formed by a plurality of wave units. The wave unit refers to a single wave structure composed of a wave crest, a wave rod and a wave trough. The shape of the wave unit is not limited. Each wave structure can be a regular ring structure formed by a plurality of wave units with the same height, or an irregular ring structure including high and low waves formed by wave units with different heights.

[0043] As shown in Figure 5 In combination Figure 1 As shown, the plurality of support rods are arranged at intervals. The width of any support rod is defined as W, and W satisfies 0.4mm≤W≤0.8mm. The thickness of the support rod is defined as D, and D satisfies 0.4mm≤D≤0.8mm. The interval distance between any two adjacent support rods is defined as L, and L satisfies 4mm≤L≤4.6mm. The interval distance between any two adjacent support rods is slightly larger than the height of the cartilage ring, so that the cartilage ring of the trachea can be embedded between the two adjacent support rods. The width of the support rod is slightly smaller than the gap between the adjacent two cartilage rings, so that the support rod can be embedded in the membrane part between the adjacent two cartilage rings.

[0044] The first occlusion disc 11 comprises a center axis passing through the geometric center of the occlusion member 111. The number of the second supports 113 is at least one, and any second support 113 does not cross the center axis. The occlusion member 111 is a circular occlusion film layer. The first surface 111a of the occlusion film layer is provided with five support rods, and the five support rods extend in the first direction and are arranged at intervals. The two ends of each support rod extend to the edge of the occlusion film layer, so as to facilitate better expansion of the first occlusion disc 11. The second surface 111b of the occlusion film layer is provided with a wave structure as the second support 113. The wave structure extends in the second direction, and two wave structures are arranged. The support rods are arranged at intervals in the second direction. In one embodiment, as shown in Figure 8As shown, the second direction is perpendicular to the first direction, i.e. the included angle a between the first direction and the second direction is 90°. The direction of the central axis can be the same as the second direction or different from the second direction. In the present embodiment, as shown in Figure 8 As shown, the direction of the central axis is the same as the second direction, so the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. Here, the single second support member 113 not crossing the central axis means that the first wave-shaped structure 113a and the second wave-shaped structure 113b as the single second support member 113 are each on one side of the central axis and do not cross the central axis to the other side, so that the wave-shaped structure does not affect the folded first occlusion disc 11 to be folded in half along the central axis, thereby facilitating the collection in the sheath tube 22. In other embodiments, the direction of the central axis is different from the second direction, the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. As long as the two wave-shaped structures of the second support member 113 extend along the second direction, the single wave-shaped structure as the single second support member 113 does not cross the central axis, as shown in Figure 9 As shown, the direction of the central axis is the same as the second direction, so the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. Here, the single second support member 113 not crossing the central axis means that the first wave-shaped structure 113a and the second wave-shaped structure 113b as the single second support member 113 are each on one side of the central axis and do not cross the central axis to the other side, so that the wave-shaped structure does not affect the folded first occlusion disc 11 to be folded in half along the central axis, thereby facilitating the collection in the sheath tube 22. In other embodiments, the direction of the central axis is different from the second direction, the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. As long as the two wave-shaped structures of the second support member 113 extend along the second direction, the single wave-shaped structure as the single second support member 113 does not cross the central axis, as shown in Figure 10 As shown, the direction of the central axis is the same as the second direction, so the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. Here, the single second support member 113 not crossing the central axis means that the first wave-shaped structure 113a and the second wave-shaped structure 113b as the single second support member 113 are each on one side of the central axis and do not cross the central axis to the other side, so that the wave-shaped structure does not affect the folded first occlusion disc 11 to be folded in half along the central axis, thereby facilitating the collection in the sheath tube 22. In other embodiments, the direction of the central axis is different from the second direction, the central axis is a radial line D1 passing through the center of the occlusion member 111 and perpendicular to the first direction, and the two wave-shaped structures are distributed on both sides of the central axis and extend along the second direction. The second support member 113 includes a first wave-shaped structure 113a and a second wave-shaped structure 113b. As long as the two wave-shaped structures of the second support member 113 extend along the second direction, the single wave-shaped structure as the single second support member 113 does not cross the central axis, as shown in

[0045] Further, the support rod includes a first support rod 1121 and a second support rod 1122 arranged at the edge of the occlusion member 111. The first support rod 1121 and the second support rod 1122 are two outermost support rods perpendicular to the extension direction of the first support member 112, i.e. perpendicular to the first direction. When the occlusion film layer is circular, the first support rod 1121 and the second support rod 1122 can be arranged as arc-shaped support rods abutting the edge of the occlusion film layer. In other embodiments, the occlusion film layer is a circular film layer, and the first support rod 1121 and the second support rod 1122 can also be arranged as straight rods, as shown in Figures 4-5 In combination with Figures 8-10The blocking film layer can also be circular, and the edges of the blocking film layer at the positions of the first support rods 1121 and the second support rods 1122 can be prevented from being rolled by being along the first support rods 1121 or the second support rods 1122.

[0046] As shown in FIG. 1, the blocking member 111 is at least crossed by the second support member 113 once between any two first support members 112. In one embodiment, as shown in FIG. 1, the first wave structure 113a and the second wave structure 113b are both at least crossed once between all the support rods, and in other embodiments, the first wave structure 113a can be crossed by the other side of the second direction between some of the adjacent support rods, and the second wave structure 113b can be crossed by the other side of the second direction between the rest of the adjacent support rods. Figures 8-10 As shown in FIG. 1, the blocking member 111 is at least crossed by the second support member 113 once between any two first support members 112. In one embodiment, as shown in FIG. 1, the first wave structure 113a and the second wave structure 113b are both at least crossed once between all the support rods, and in other embodiments, the first wave structure 113a can be crossed by the other side of the second direction between some of the adjacent support rods, and the second wave structure 113b can be crossed by the other side of the second direction between the rest of the adjacent support rods. Figure 8 As shown in FIG. 1, the blocking member 111 is at least crossed by the second support member 113 once between any two first support members 112. In one embodiment, as shown in FIG. 1, the first wave structure 113a and the second wave structure 113b are both at least crossed once between all the support rods, and in other embodiments, the first wave structure 113a can be crossed by the other side of the second direction between some of the adjacent support rods, and the second wave structure 113b can be crossed by the other side of the second direction between the rest of the adjacent support rods. Figures 9-10 As shown in FIG. 1, the blocking member 111 is at least crossed by the second support member 113 once between any two first support members 112. In one embodiment, as shown in FIG. 1, the first wave structure 113a and the second wave structure 113b are both at least crossed once between all the support rods, and in other embodiments, the first wave structure 113a can be crossed by the other side of the second direction between some of the adjacent support rods, and the second wave structure 113b can be crossed by the other side of the second direction between the rest of the adjacent support rods.

[0047] Further, the end of the second support member 113 and the projection of the most marginal first support member 112 on the blocking member 111 at least partially overlap, wherein the most marginal first support member refers to the first support member closest to the edge of the blocking member. Wherein the first wave structure 113a comprises a first end 1131 and a second end 1132, and the second wave structure 113b comprises a third end 1133 and a fourth end 1134, the first end 1131 and the third end 1133 are located on the same side of the first support rod 1121, and the second end 1132 and the fourth end 1134 are located on the same side of the second support rod 1122, at least one end of the first end 1131 and the third end 1133 extends to the corresponding position of the first support rod 1121, and at least one end of the second end 1132 and the fourth end 1134 extends to the corresponding position of the second support rod 1122, so that the wave structure of the second support member 113 and the projection of the most marginal first support rod 1121 / second support rod 1122 on the blocking member 111 at least partially overlap. In this embodiment, the first end 1131 of the first wave structure 113a extends to the corresponding position of the first support rod 1121, and the second end 1132 of the first wave structure 113a extends to the corresponding position of the second support rod 1122; the third end 1133 of the second wave structure 113b extends to the corresponding position of the first support rod 1121, and the fourth end 1134 of the second wave structure 113b extends to the corresponding position of the second support rod 1122, the end of the first wave structure 113a and the projection of the most marginal first support rod 1121 and the second support rod 1122 on the blocking member 111 overlap, and the end of the second wave structure 113b and the projection of the most marginal first support rod 1121 and the second support rod 1122 on the blocking member 111 overlap, thereby facilitating the second support member 113 to expand the first blocking disc 11 in the second direction.

[0048] In one embodiment, the second support member 113 of the first blocking disc 11 extends in the second direction, and the angle between the second direction and the first direction is 75°, as shown in FIG. 1B. Figure 9As shown, the second support member 113 includes a first waveform structure 113a and a second waveform structure 113b. The first waveform structure 113a includes a first end 1131 and a second end 1132. The second waveform structure 113b includes a third end 1133 and a fourth end 1134. The first end 1131 and the third end 1133 are located on the same side as the first support rod 1121. The second end 1132 and the fourth end 1134 are located on the same side as the second support rod 1122. The second end 1132 of the first waveform structure 113a extends to the position corresponding to the second support rod 1122, gradually approaching the central axis but not crossing the central axis. The third end 1133 of the second waveform structure 113b extends to the position corresponding to the first support rod 1121, gradually approaching the central axis but not crossing the central axis, so that the waveform structure of the second support member 113 at least partially overlaps with the projection of the outermost first support rod 1121 / second support rod 1122 on the sealing member 111.

[0049] The second sealing disc 13 includes a support mesh and a flow-blocking membrane. The support mesh can be woven from nickel-titanium alloy wires into a grid shape, and the ends of the woven nickel-titanium wires are gathered and pressed tightly within the distal opening 122 of the waist 12. Figure 3 As shown, a double-layer metal mesh is formed through heat treatment. The diameter of the braided filaments supporting the mesh can be selected from 0.1mm to 0.3mm. The dimensions of the first and second sealing discs in any direction can be set from 10mm to 25mm. To better fit the cartilage rings of the tracheal wall and ensure that the size of the first sealing disc is appropriate, the number of support rods can be set from 3 to 9. The first sealing disc can be set as a circular or elliptical disc. When the first sealing disc is set as an elliptical disc, its minor axis is along the first direction, and its major axis is perpendicular to the first direction. This allows it to cross more cartilage rings along the tracheal wall channel direction when released onto the tracheal wall, maintaining better fit and sealing. However, the size of the sealing disc in the circumferential direction of the tracheal wall should not be too large. The flow-blocking membrane is attached to the inner surface of the metal mesh and can be sewn into the metal mesh with sutures. It is understood that the flow-blocking membrane is a membrane layer made of a biocompatible polymer material.

[0050] Understandably, the number of support rods can be set to 3, 4, 5, 6, 7, 8, or 9. When the number of support rods is set to an even number, another connecting rod that cooperates with the connector can be set between the two middle support rods. This connecting rod does not need to extend to the outermost edge of the sealing device. It is only necessary to ensure that the first sealing disc and the second sealing disc are connected into an integral tracheoesophageal device using the connector and the connecting rod, which can be used as a occluder to seal the tracheoesophageal fistula opening.

[0051] like Figures 1-3 Combination Figure 11As shown, the connecting piece 14 comprises a connecting portion 141, an intermediate portion 142 and an embedding portion 143, wherein the embedding portion 143 is arranged at the distal end of the connecting piece 14, and is used to be embedded into the proximal end opening 121 of the waist portion 12, so that the connecting piece 14 is connected with the waist portion 12, and the embedding portion 143 of the connecting piece 14 can be further welded into the proximal end opening 121 of the waist portion 12 to ensure the reliability of the connection. The intermediate portion 142 comprises a through connecting slot, and the extension direction of the connecting slot 1421 is the same as the extension direction of the first support piece 112, and the connecting slot 1421 is arranged on the side of the blocking piece 111 close to the second blocking disc 13, and at least one first support piece 112 passes through the connecting slot 1421. In an embodiment, the first support piece 112 comprises an intermediate support rod 1123, the intermediate support rod 1123 passes through the connecting slot 1421 along the first direction thereof, and can be further welded together, so that the intermediate support rod 1123 is fixedly connected with the connecting piece 14. In an embodiment, the connecting portion 141 is provided with external threads or internal threads, which are used to be connected with the conveying steel cable 21 of the conveyor 20, so that the tracheal / esophageal device 10 is bundled in the sheath tube 22 of the conveyor 20. In this embodiment, the center of the blocking piece 111 is provided with a through hole 1111, which is used for the connecting portion 141 of the connecting piece 14 to pass through, so that the connecting portion 141 of the connecting piece 14 is connected with the conveying steel cable 21 on the side of the blocking piece 111 away from the second blocking disc 13, so that the first blocking disc 11 and the second blocking disc 13 are connected as a whole by the connecting piece 14 and the waist portion 12, and the tracheal / esophageal device 10 is connected with the conveying steel cable 21, and the conveying steel cable 21 is connected with the sheath tube 22 of the conveyor 20, so that the tracheal / esophageal device 10 is bundled in the sheath tube 22 of the conveyor 20. Figures 4-7

[0052] In other embodiments, the first blocking disc 11 further comprises a plating layer, which is wrapped on the surface of the first blocking disc 11, and the material of the plating layer can be medical silica gel, and the plating layer is in the form of solid glue when it is coated on the first blocking disc 11. It can be understood that the plating layer can be coated on the surface of the first blocking disc 11 by solution immersion coating, so that the first support piece 112 of the first blocking disc 11 is not exposed to the outside, and when the first face 111a of the first blocking disc 11 is removed from the tracheal wall, the first support piece 112 can be prevented from directly contacting the tracheal wall. On the other hand, by means of solution immersion coating, uniform coating of the first blocking disc 11 can be achieved, and the arrangement of the plating layer will not affect the spacing formed between the plurality of first support pieces 112, and the protrusions formed between the first support pieces 112 and the first face 111a of the blocking piece 111 are reserved, so that the cartilage rings of the tracheal wall can be embedded in the spacing between adjacent first support pieces 112, and the first support pieces 112 can be correspondingly clamped into the membrane portions between the cartilage rings of the tracheal wall to extrude the membrane portions to slightly deform, so as to achieve mutual embedding sealing of the first blocking disc 11 and the tracheal wall, and the adhesion, stability and air tightness between the first blocking disc 11 of the tracheal / esophageal device 10 and the tracheal wall can be improved, and subsequent further sealing of the fistula by glue is not required.

[0053] ​The silicone coating on the first sealing disc 11 is applied as follows: First, the connector 14 is passed through the hole in the center of the sealing membrane. Then, the first support 112 and the second support 113 are fixed to the membrane of the sealing component 111 by stitching or gluing. The intermediate support rod 1123 passes through the connecting groove 1421 of the connector 14, allowing the connector 14 to connect to the first sealing disc 11 via the first support 112. The connector 14, the first support 112, the second support 113, and the sealing membrane are then immersed in a prepared silicone solution. Afterward, they are removed, dried, and baked to cure the silicone coating. The thickness of the silicone coating can be adjusted by changing the immersion time or the number of immersions. The coating thickness is between 0.1 mm and 0.5 mm. The silicone coating is tightly bonded to the metal wires or rods of the first and second support components 112 and 113, and deformation of the metal supports does not affect the integrity of the coating with the supports. Because the first support member 112 and the second support member 113 extend in different directions, the first sealing disc 11 can unfold circumferentially. Simultaneously, multiple first support members 112 extend along the first direction and are spaced apart on the first surface 111a, allowing the first support members 112 to correspondingly engage with the membrane portion between the cartilage rings of the tracheal inner wall, causing slight deformation of the membrane portion. This achieves an interlocking sealing between the first sealing disc 11 and the tracheal inner wall, increasing the fit, stability, and airtightness between the first sealing disc 11 and the tracheal wall of the tracheoesophageal device 10, eliminating the need for further adhesive application to seal the fistula. Furthermore, combined with the cooperation of the second sealing disc 13 and the waist portion 12, the first sealing disc 11 is pulled and adheres to the tracheal inner wall at the fistula opening, resulting in superior airtightness for the first sealing disc 11 of the tracheoesophageal device 10.

[0054] The present invention also provides a trachea / esophagus system 100, such as Figures 12-15 As shown, the tracheoesophageal system 100 includes a delivery device 20 and a tracheoesophageal device 10 as described above. The delivery device 20 includes a delivery cable 21 and a sheath 22. The sheath 22 is arranged around the delivery cable 21. The distal end of the delivery cable is detachably connected to the proximal end of the first sealing disc away from the second sealing disc. In one embodiment, the distal end of the delivery cable 21 is detachably connected to the proximal end of the tracheoesophageal device 10. The distal end of the delivery cable 21 is provided with an internal thread, and the connecting portion 141 of the connector 14 is provided with an external thread, thereby facilitating the detachable connection of the distal end of the delivery cable 21 to the proximal end of the tracheoesophageal device 10 through the internal and external threads.

[0055] like Figures 13-15 As shown, the first sealing disc 11 of the trachea / esophagus device 10 is rolled up in a direction perpendicular to the first support member 112. Figure 13or after the first blocking disc 11 is stacked, and the first support 112 is folded, so that the first blocking disc 11 is bundled in the sheath tube 22. In one embodiment, as shown in the figure, the first blocking disc 11 is gradually rolled up from both ends along the second direction (the first direction perpendicular to the paper in the figure) towards the second face 111b, or is directly stacked along the direction, and the structure of the first blocking disc 11 after being rolled up is shown in the figure. Figure 13 As shown in the figure, in one embodiment, the first blocking disc 11 is gradually rolled up from both ends along the second direction (the first direction perpendicular to the paper in the figure) towards the second face 111b, or is directly stacked along the direction, and the structure of the first blocking disc 11 after being rolled up is shown in the figure. Figures 14-15 As shown in the figure, in one embodiment, the first blocking disc 11 is gradually rolled up from both ends along the second direction (the first direction perpendicular to the paper in the figure) towards the second face 111b, or is directly stacked along the direction, and the structure of the first blocking disc 11 after being rolled up is shown in the figure. Figure 12 As shown in the figure. When the trachea / esophagus system 100 is assembled, the connecting part 141 at the proximal end of the trachea / esophagus device 10 can be screwed to the distal end of the delivery steel cable 21, and then the second blocking disc 13, the waist part 12 and the first blocking disc 11 can be sequentially bundled in the sheath tube 22 from the proximal end of the sheath tube 22, and the trachea / esophagus device 10 can be pushed to the loading position at the distal end of the sheath tube 22 by using the delivery steel cable 21, so as to realize the assembly of the trachea / esophagus device 10. The trachea / esophagus system 100 can deliver the trachea / esophagus device 10 along the trachea to the fistula, pass through the fistula into the esophagus, release the second blocking disc in sequence by withdrawing the sheath tube, so that the second blocking disc is released in the esophagus, then gradually release the waist part, and then pull the whole body so that the second blocking disc is attached to the inner wall of the esophagus, so that the sheath tube releases the first blocking disc in the trachea, so that the first blocking disc is attached to the inner wall of the trachea, and then the thread of the delivery steel cable is rotated and the delivery device is withdrawn, so as to complete the release of the trachea / esophagus device.

[0056] The technical features of the above-described embodiments can be combined in any manner. In order to make the description concise, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not conflict, they should be considered as falling within the scope of the present disclosure.

[0057] The above-described embodiments only express several embodiments of the present application, and the description is relatively specific and detailed, but it should not be understood as limiting the scope of the patent. It should be pointed out that for ordinary skilled persons in the art, some modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present patent should be subject to the appended claims.

Claims

1. A tracheal / esophageal device, characterized by, The trachea / oesophagus device comprises a first blocking disc, a waist part and a second blocking disc, one end of the waist part is connected to the first blocking disc, the other end of the waist part is connected to the second blocking disc, the first blocking disc comprises a blocking piece and at least two first support pieces extending in a first direction, the two first support pieces are arranged at intervals on the blocking piece, the first blocking disc further comprises a second support piece extending in a second direction, the first support piece and the second support piece are used to naturally unfold the blocking piece, the first support piece comprises a support rod, the first support piece is arranged on the side of the blocking piece close to the second blocking disc; the second support piece comprises a wave structure, the second support piece is arranged on the side of the blocking piece away from the second blocking disc.

2. The tracheal / esophageal device according to claim 1, characterized in that The included angle between the first direction and the second direction is defined as α, and α satisfies: 75°≤α≤90°.

3. The tracheal / esophageal device according to claim 1, wherein, A plurality of support rods are arranged at intervals, the width of any support rod is defined as W, and W satisfies: 0.8mm≤W≤1.5mm; the interval distance between any two adjacent support rods is defined as L, and L satisfies: 3.5mm≤L≤4.5mm.

4. The tracheal / esophageal device according to claim 1, wherein, The first blocking disc comprises a central axis, the central axis passes through the geometric center of the blocking piece, the number of the second support pieces is at least one, and any second support piece does not cross the central axis.

5. The tracheal / esophageal device according to claim 1, wherein, The projection of the second support piece and the outermost first support piece on the blocking piece at least partially overlaps.

6. The tracheal / esophageal device according to claim 1, wherein, Any two first support pieces are crossed by the second support piece at least once.

7. The tracheal / esophageal device according to claim 1, wherein, The second blocking disc comprises a double-layer woven wire mesh disc, the two ends of the waist part are in an open structure, the woven wire of the second blocking disc is bundled in the opening at one end of the waist part close to the end of the first blocking disc; the trachea / oesophagus device further comprises a connecting piece, one end of the connecting piece is arranged in the opening at the other end of the waist part, the end of the connecting piece away from the second blocking disc penetrates through the first blocking disc, and the end of the connecting piece penetrating through the first blocking disc is provided with a connecting part.

8. The tracheal / esophageal device according to claim 7, characterized in that The connecting piece comprises a communication groove, the communication groove is arranged on the side of the connecting piece close to the second blocking disc, and the extension direction of the communication groove is the same as that of the first support piece, and at least one first support piece penetrates through the communication groove.

9. A trachea / oesophagus system characterised in that, The trachea / oesophagus system comprises a delivery device and the trachea / oesophagus device according to any one of claims 1-8, the delivery device comprises a delivery steel cable and a sheath tube, the sheath tube surrounds the delivery steel cable, the distal end of the delivery steel cable is detachably connected to the end of the first blocking disc away from the second blocking disc, after rolling up or stacking the first blocking disc in the direction perpendicular to the first support piece, and folding the first support piece, the first blocking disc is bundled in the sheath tube.

Images