Tracheal / esophageal devices and systems

Abstract

The invention relates to a tracheal / esophageal device and a tracheal / esophageal system.The tracheal / esophageal device comprises a first plugging disc, a waist part and a second plugging disc, one end of the waist part is connected with the first plugging disc, and the other end of the waist part is connected with the second plugging disc; the first plugging disc comprises a plugging piece and at least two first supporting pieces extending in the first direction, the two first supporting pieces are arranged on the plugging piece in a spaced mode, the first plugging disc further comprises a second supporting piece extending in the second direction, and the first supporting pieces and the second supporting piece are used for naturally unfolding the plugging piece. According to the trachea / esophagus device, the first plugging disc comprises the plugging piece and the at least two first supporting pieces extending in the first direction, the two first supporting pieces are arranged on the plugging piece in the spaced mode, the second supporting piece extends in the second direction, and the first supporting pieces and the second supporting piece are matched so that the plugging piece can be naturally unfolded; therefore, the tracheoesophageal fistula is blocked.

Description

Technical Field

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

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

[0003] The principle of tracheoesophageal fistula treatment is to determine the location of the fistula, restore esophageal continuity, prevent and control infection, drain the abscess cavity, and ensure adequate nutrition supply. At present, surgery is the main way to treat tracheoesophageal fistula (TEF), but a series of complications such as chest infection, bleeding, and stent slippage often occur after surgery. Among them, the treatment of recurrence of esophageal tracheal fistula is particularly difficult. In recent years, studies have successfully blocked esophageal tracheal fistula using atrial septum / ventricular septum occluders. However, the existing occluders are limited by their own weight and the compression of the occluders on the surrounding tissues, causing ischemic necrosis or even occluder detachment, blocking the airway and causing death. At the same time, due to the limitations of the occluder's own structure, the occluder cannot adapt well to the shape of the tracheoesophageal wall during occlusion, resulting in gaps at the fistula, which easily causes gas leakage and leads to surgical failure. In addition, the occluder is not firmly combined with the surrounding tissues, resulting in exudate at the fistula position, which easily causes symptoms of repeated fever and cough.

[0004] In summary, providing a tracheoesophageal fistula tracheal / esophageal device with good adaptability and good wall adhesion has become one of the urgent problems to be solved in the treatment of tracheoesophageal fistula at this stage. Summary of the invention

[0005] A technical problem solved by the present invention is how to provide a tracheal / esophageal device and system with good adaptability and good wall adhesion.

[0006] The present invention provides a trachea / esophagus device, which includes a first sealing disk, a waist and a second sealing disk, one end of the waist is connected to the first sealing disk, and the other end of the waist is connected to the second sealing disk, the first sealing disk includes a sealing member and at least two first support members extending along a first direction, two first support members are arranged at intervals from the sealing member, the first sealing disk also includes a second support member extending along a second direction, and the first support member and the second support member are used to naturally unfold the sealing member.

[0007] In one embodiment, the angle between the first direction and the second direction is defined as α, and α satisfies: 75°≤α≤90°.

[0008] In one embodiment, the first support member is configured to include a support rod, and the first support member is disposed on a side of the sealing member close to the second sealing disk; the second support member includes a corrugated structure, and the second support member is disposed on a side of the sealing member away from the second sealing disk.

[0009] In one embodiment, the plurality of support rods are spaced apart, and the width of any support rod is defined as W, then W satisfies: 0.8mm≤W≤1.5mm; the spacing distance between any two adjacent support rods is defined as L, then L satisfies: 3.5mm≤L≤4.5mm.

[0010] In one embodiment, the first sealing disk includes a central axis, and the central axis passes through the geometric center of the sealing member. The number of the second support members is at least one, and any single second support member does not cross the central axis.

[0011] In one embodiment, the projection of the second supporting member and the outermost first supporting member on the blocking member at least partially overlaps.

[0012] In one embodiment, any two of the first supporting members are spanned by the second supporting member at least once.

[0013] In one embodiment, the second occluding disk comprises a double-layer woven wire mesh disk, and the two ends of the waist are open structures, and the woven wires of the second occluding disk are gathered in the opening at one end of the waist near the end of the first occluding disk; the trachea / esophagus device also includes a connecting piece, one end of the connecting piece is placed in the opening at the other end of the waist, the end of the connecting piece away from the second occluding disk passes through the first occluding disk, and the other end of the connecting piece passing through the first occluding disk is provided with a connecting portion.

[0014] In one embodiment, the connecting member includes a connecting groove, the connecting groove has the same extension direction as the first supporting member, and is arranged on a side of the connecting member close to the second sealing disk, and at least one of the first supporting members passes through the connecting groove.

[0015] The present invention also provides a trachea / esophagus system, which includes a conveyor and a trachea / esophagus device as described above, wherein the conveyor includes a conveying steel cable and a sheath, wherein the sheath surrounds the conveying steel cable, and the distal end of the conveying steel cable is detachably connected to the end of the first occluding disk away from the proximal end of the second occluding disk, and after the first occluding disk is rolled up or stacked in a direction perpendicular to the first support member, the first support member is folded in half, thereby the first occluding disk is contracted within the sheath.

[0016] A technical effect of an embodiment of the present invention is to provide a trachea / esophagus device, wherein a first blocking disk includes a blocking member and at least two first support members extending along a first direction, and the two first support members are spaced apart from the blocking member, and a second support member extending along a second direction, wherein the first support member and the second support member cooperate to facilitate the natural expansion of the blocking member, thereby achieving blocking of the tracheoesophageal fistula. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A schematic diagram of the structure of a tracheal / esophageal device in one embodiment of the present invention;

[0018] Figure 2 A schematic structural diagram of a waist portion and a connecting member in one embodiment of the present invention;

[0019] Figure 3 for Figure 2 The cross-sectional view along the AA direction;

[0020] Figure 4 A schematic structural diagram of a first sealing disk in one embodiment of the present invention;

[0021] Figure 5 A plan view of a first surface of a first sealing disk in one embodiment of the present invention;

[0022] Figure 6 A schematic structural diagram of another direction of the first blocking disk in one embodiment of the present invention;

[0023] Figure 7 A plan view of the second surface of the first sealing disk in one embodiment of the present invention;

[0024] Figure 8 for Figure 5 A schematic diagram showing the second side in perspective;

[0025] Fig. 9 A schematic diagram of a first surface of a first sealing disk in another embodiment of the present invention (with the second support member on the second surface shown in perspective);

[0026] Fig.10 A schematic diagram of a first surface of a first sealing disk in yet another embodiment of the present invention (with the second support member on the second surface shown in perspective);

[0027] Fig.11 For the waist Figure 2 The cross-section along the AA direction;

[0028] Fig.12 A schematic diagram of the structure of a trachea / esophagus system in one embodiment of the present invention;

[0029] Fig.13 A side view of a first sealing disk before it is rolled up in the direction of the arrow in the figure in one embodiment of the present invention;

[0030] Fig.14 A schematic diagram of the structure of a first sealing disk after it is rolled up along the direction of the arrow in the figure in one embodiment of the present invention;

[0031] Fig.15 This is a schematic structural diagram of another direction after the first sealing disk is rolled up along the direction of the arrow in one embodiment of the present invention.

[0032] 10. tracheal / esophageal device; 11. first occluding disk; 111. occluding member; 111a. first surface; 111b. second surface; 1111. perforation; 112. first support member; 1121. first support rod; 1122. second support rod; 1123. middle support rod; 113. second support member; 113a. first wave-shaped structure; 113b. second wave-shaped structure; 1131. first end; 1132. second end; 1133. third end; 1134. fourth end; 12. waist; 121. proximal opening; 122. distal opening; 13. second occluding disk; 14. connecting member; 141. connecting portion; 142. middle portion; 1421. connecting groove; 143. embedded portion;

[0033] 100. Tracheal / esophageal system; 20. Delivery device; 21. Delivery cable; 22. Sheath. DETAILED DESCRIPTION

[0034] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thoroughly understood.

[0035] It should be noted that when an element is referred to as being "fixed to" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "inside", "outside", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.

[0036] "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction. The "axial" and "radial" of any component of the medical device are defined based on this principle. In the field of interventional medical devices, for a delivery device that delivers a medical device when it is implanted in a human or animal body, the end closer to the operator is defined as the "proximal end", and the end farther from the operator is defined as the "distal end". The "proximal end" and "distal end" of any component of the delivery device are defined based on this principle.

[0037] The present invention provides a tracheal / esophageal device 10, such as Figure 1-15 As shown, the trachea / esophagus device 10 includes a first occluding plate 11, a waist 12 and a second occluding plate 13. One end of the waist 12 is connected to the first occluding plate 11, and the other end of the waist 12 is connected to the second occluding plate 13. The waist 12 can be directly connected to the first occluding plate 11, or indirectly connected to the first occluding plate 11 through a connector 14, thereby connecting the first occluding plate 11 and the second occluding plate 13 into an integral trachea / esophagus device 10.

[0038] In one embodiment, in combination Figure 1 and Figure 4-8 As shown, the trachea / esophageal device 10 includes a first blocking disk 11, a waist 12 and a second blocking disk 13 from the proximal end to the distal end, wherein the first blocking disk 11 includes a blocking member 111, at least two first support members 112 extending along a first direction and a second support member 113 extending along a second direction, and the two first support members 112 are spaced apart from the blocking member 111, wherein the first support member 112 and the second support member 113 are used to naturally unfold the blocking member 111, so that when the first blocking disk 11 is not subjected to force, it can naturally expand and unfold into a disk shape.

[0039] Among them, Figure 2-3As shown, both ends of the waist 12 are open structures for connecting the first occluding disk 11 and the second occluding disk 13. The tracheal / esophageal device 10 also includes a connector 14. The second occluding disk 13 includes a double-layer woven wire mesh disk. The end of the woven wire of the second occluding disk 13 close to the first occluding disk is gathered in the opening at one end of the waist 12. One end of the connector 14 is inserted into the opening at the other end of the waist 12. The end of the connector 14 away from the second occluding disk passes through the first occluding disk 11, and the end of the connector 14 passing through the first occluding disk is provided with a connecting portion 141. The first occluding disk 11 and the second occluding disk 13 are indirectly connected into a whole through the connector 14. The connecting portion 141 of the connector 14 can be used to connect with the conveying cable 21 of the conveyor 20, so as to gather the tracheal / esophageal device 10 in the sheath 22 of the conveyor 20.

[0040] In one embodiment, if Fig.11 Combination Figure 3 As shown, the proximal opening 121 of the waist 12 is used to connect the first occluding disk 11, and the distal opening 122 of the waist 12 is used to connect the second occluding disk 13. The proximal opening 121 of the waist 12 is connected to the distal end of the connecting piece 14, and the distal end of the connecting piece 14 is embedded in the proximal opening 121 of the waist 12, and the waist 12 and the connecting piece 14 are further welded together to ensure the connection reliability.

[0041] In one embodiment, if Figure 4-8 As shown, the first sealing disk 11 includes a sealing member 111 , a plurality of first support members 112 extending along a first direction, and a plurality of second support members 113 extending along 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 . Among them, the blocking member 111 is set as a blocking film layer, and the blocking film layer can be made of polytetrafluoroethylene (PTFE) film. The blocking member 111 includes a first surface 111a and a second surface 111b, wherein the first surface 111a is the side of the blocking member 111 close to the second blocking disk 13, and the second surface 111b is the side of the blocking member 111 away from the second blocking disk 13. A plurality of first support members 112 extend along the first direction and are arranged at intervals on the first surface 111a. The first support member 112 includes a support rod. In one embodiment, the first support member is set as a support rod, and the support rod extends along the first direction. When the converged first blocking disk 11 is released from the sheath 22, the first support member 112 facilitates the expansion of the blocking member 111 along the first direction, wherein the material of the support rod is selected from self-expandable materials such as nickel-titanium alloy wire or nickel-titanium alloy rod. The first support member 112 is arranged on one side of the sealing member 111 close to the second sealing disk 13, so that a plurality of spaced support rods can be inserted into the membrane portion between the inner wall of the trachea, and the cartilage rings of the inner wall of the trachea can be embedded in the space between adjacent support rods, thereby making the first sealing disk 11 better adhere to the inner wall of the trachea.

[0042] The second support member 113 is arranged on the side of the blocking member 111 away from the second blocking disk 13, and the second support member 113 is arranged on the second surface 111b along the second direction. The second support member 113 includes a corrugated structure. In one embodiment, the second support member is arranged as a corrugated structure, and the corrugated structure extends along the second direction. When the first blocking disk 11 that is gathered is released from the sheath 22, the second support member 113 facilitates the expansion of the blocking member 111 along 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 member 112 and the second support member 113 can expand the entire blocking member 111 in the circumferential direction. When the tracheal / esophageal device 10 gathered in the conveyor 20 is released from the sheath 22, the first support member 112 and the second support member 113 can expand the entire disk surface of the first blocking disk 11, so as to be attached to the fistula opening of the tracheoesophageal fistula. Among them, the waveform structure is a sinusoidal waveform formed by extending multiple waveform units, wherein the waveform unit refers to a single wave structure composed of a crest, a wave rod and a wave trough, and the shape of the waveform unit is not limited; each waveform structure can be a regular annular structure formed by multiple waveform units of equal height, or it can be an irregular annular structure including high and low waves formed by waveform units of different wave heights, which is not limited here.

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

[0044] The first blocking disk 11 includes a central axis, which passes through the geometric center of the blocking member 111. The number of second support members 113 is at least one, and any second support member 113 does not cross the central axis. The blocking member 111 is a circular blocking film layer, and the first surface 111a of the blocking film layer is provided with 5 support rods. The 5 support rods all extend along the first direction and are arranged at intervals. Both ends of each support rod extend to the edge of the blocking film layer, so as to facilitate the first blocking disk 11 to be deployed more effectively. The second surface 111b of the blocking film layer is provided with a corrugated structure as the second support member 113. The corrugated structure extends along the second direction, and two corrugated structures are provided. The support rods are arranged at equal intervals along the second direction. In one embodiment, Figure 8As shown, the second direction is perpendicular to the first direction, that is, the angle α 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 this embodiment, Figure 8 As shown, the direction of the central axis is the same as the second direction, then the central axis is the radial line D1 passing through the center of the sealing member 111 and perpendicular to the first direction, the two corrugated structures are distributed on both sides of the central axis, and both extend along the second direction, the second support member 113 includes a first corrugated structure 113a and a second corrugated structure 113b, wherein a single second support member 113 does not cross the central axis means that the first corrugated structure 113a and the second corrugated structure 113b as a 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 corrugated structure does not affect the folding of the rolled-up first sealing disk 11 along the central axis, thereby facilitating the contraction in the sheath 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 blocking member 111 and perpendicular to the first direction, the two wave structures are distributed on both sides of the central axis, and both extend along the second direction, the second support member 113 includes a first wave structure 113a and a second wave structure 113b, and it is sufficient that the single wave structure as a single second support member 113 does not cross the central axis when the two wave structures of the second support member 113 extend along the second direction, such as Fig. 9 As shown. Fig.10 As shown, the angle between the direction of the central axis D1 and the extension direction (first direction) of the first support member 112 can also be defined as β, and β satisfies: 75°≤β≤90°. The only difference from the aforementioned embodiment is that the state in which it is folded and gathered into the conveyor 20 is different, that is, the folding state of the trachea / esophagus device 10 in the trachea / esophagus system 100 is not limited. It only needs to be conveniently rolled up, folded and gathered in the sheath 22, and does not affect the unfolding of the blocking member 111 with the help of the first support member 112 and the second support member 113 after its release. No further details are given here.

[0045] Further, the support rod includes a first support rod 1121 and a second support rod 1122 arranged at the edge of the blocking member 111, and the first support rod 1121 and the second support rod 1122 are the two outermost support rods at both ends perpendicular to the extension direction of the first support member 112 (i.e., perpendicular to the first direction). When the blocking film layer is circular, the first support rod 1121 and the second support rod 1122 can be set as arc-shaped support rods that fit the edge of the blocking film layer. In other embodiments, the blocking film layer is a circular film layer, and the first support rod 1121 and the second support rod 1122 can also be set as straight rods, such as Figure 4-5 Combination Figure 8-10As shown; the blocking film layer can also be quasi-circular, and the edge of the blocking film layer at the position corresponding to the first support rod 1121 and the second support rod 1122 is along the first support rod 1121 or the second support rod 1122 to prevent the edge of the blocking film layer from curling.

[0046] like Figure 8-10 As shown, the blocking member 111 between any two first supporting members 112 is crossed by the second supporting member 113 at least once. Figure 8 As shown, the first corrugated structure 113a and the second corrugated structure 113b both cross the intervals between all the support rods at least once. In other embodiments, the first corrugated structure 113a may cross the other side of the intervals between some adjacent support rods along the second direction, and the second corrugated structure 113b may cross the other side of the intervals between the remaining adjacent support rods along the second direction. Figure 9-10 As shown, it is only necessary to ensure that the other side of the interval between any two first support members 112 is crossed by at least one of the second support members 113 once along the second direction, so that the second support member 113 can expand the interval between all two first support members 112 .

[0047] Furthermore, the end of the second support member 113 at least partially overlaps with the projection of the first support member 112 at the outermost edge on the blocking member 111, wherein the first support member at the outermost edge refers to: the first support member that is closest to the edge of the blocking member as a whole. Among them, the first corrugated structure 113a includes a first end 1131 and a second end 1132, and the second corrugated 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, and the second end 1132 and the fourth end 1134 are located on the same side as the second support rod 1122. At least one end of the first end 1131 and the third end 1133 extends to a position corresponding to the first support rod 1121, and at least one end of the second end 1132 and the fourth end 1134 extends to a position corresponding to the second support rod 1122, so that the corrugated structure of the second support member 113 at least partially overlaps with the projection of the first support rod 1121 / second support rod 1122 at the edge on the blocking member 111. In this embodiment, the first end 1131 of the first corrugated structure 113a extends to the position corresponding to the first support rod 1121, and the second end 1132 of the first corrugated structure 113a extends to the position corresponding to the second support rod 1122; the third end 1133 of the second corrugated structure 113b extends to the position corresponding to the first support rod 1121, and the fourth end 1134 of the second corrugated structure 113b extends to the position corresponding to the second support rod 1122, and the end of the first corrugated structure 113a overlaps with the projection of the first support rod 1121 and the second support rod 1122 at the edge on the blocking member 111, and the end of the second corrugated structure 113b overlaps with the projection of the first support rod 1121 and the second support rod 1122 at the edge on the blocking member 111, thereby facilitating the second support member 113 to unfold the first blocking disk 11 in the second direction.

[0048] In one embodiment, the second support member 113 of the first sealing disk 11 extends along the second direction, and the angle between the second direction and the first direction is 75°. Fig. 9As shown, the second support member 113 includes a first corrugated structure 113a and a second corrugated structure 113b, the first corrugated structure 113a includes a first end 1131 and a second end 1132, the second corrugated 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 corrugated structure 113a extends to a position corresponding to the second support rod 1122 and gradually approaches the central axis but does not cross the central axis, the third end 1133 of the second corrugated structure 113b extends to a position corresponding to the first support rod 1121 and gradually approaches the central axis but does not cross the central axis, so that the corrugated structure of the second support member 113 at least partially overlaps with the projection of the first support rod 1121 / second support rod 1122 at the outermost edge on the blocking member 111.

[0049] The second blocking plate 13 includes a supporting mesh plate and a flow-blocking membrane. The supporting mesh plate can be woven into a grid shape by nickel-titanium alloy wires, and the wire heads of the braided ends of the nickel-titanium wires are bundled and pressed tightly into the distal opening 122 of the waist 12. Figure 3 As shown, a double-layer metal mesh disk is formed by heat treatment and shaping. The diameter range of the braided wire supporting the mesh disk can be selected: 0.1mm~0.3mm, wherein the size of the disk surface of the first occluding disk and the second occluding disk in any direction can be set to 10mm~25mm; in order to better fit the cartilage ring of the tracheal wall and ensure that the disk surface of the first occluding disk is of moderate size, the number of support rods can be set to 3~9, and the first occluding disk can be set to a disc or an elliptical disk. When the first occluding disk is set to an elliptical disk, the short axis of the ellipse is along the first direction, and the long axis of the ellipse is along the first direction perpendicular to the first direction, so that when it is released on the inner wall of the trachea, it can cross more cartilage rings along the direction of the tracheal wall channel, and can maintain better fit and closure, but the size of the occluding disk is not too large in the circumferential direction of the tracheal wall. The flow-blocking membrane is attached to the inner surface of the metal mesh disk and can be sutured into the metal mesh disk by sutures. It can be understood that the flow-blocking membrane is a membrane layer made of a polymer material with good biocompatibility.

[0050] It can be understood that 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 cooperating with the connecting piece can be set between the two middle support rods. The connecting rod does not need to extend to the outermost edge of the blocking piece. It is only necessary to ensure that the first blocking disk and the second blocking disk are connected to form an integral tracheal / esophageal device by utilizing the connecting piece and the connecting rod, which can be used as an occluder to block the tracheoesophageal fistula.

[0051] like Figure 1-3 Combination Fig.11As shown, the connector 14 includes a connecting portion 141, an intermediate portion 142 and an embedded portion 143, wherein the embedded portion 143 is disposed at the distal end of the connector 14, and is used to be embedded in the proximal opening 121 of the waist 12, so that the connector 14 is connected to the waist 12, and the embedded portion 143 of the connector 14 can be further welded to the proximal opening 121 of the waist 12 to ensure connection reliability. The intermediate portion 142 includes a through connection groove, the extension direction of the connecting groove 1421 is the same as the extension direction of the first support member 112, and is disposed on a side of the blocking member 111 close to the second blocking disk 13, and at least one first support member 112 passes through the connecting groove 1421. In one embodiment, the first support member 112 includes an intermediate support rod 1123, and the intermediate support rod 1123 passes through the connecting groove 1421 along its first direction, and can be further welded together, so that the intermediate support rod 1123 is fixedly connected to the connector 14. In one embodiment, the connecting portion 141 is provided with an external thread or an internal thread for connecting with the delivery cable 21 of the conveyor 20, so as to gather the tracheal / esophageal device 10 in the sheath 22 of the conveyor 20. Among them, a through hole 1111 is provided at the center of the blocking member 111, through which the connecting portion 141 of the connecting member 14 passes, so that the connecting portion 141 of the connecting member 14 and the delivery cable 21 are connected to the side of the blocking member 111 away from the second blocking disk 13, so that the first blocking disk 11 and the second blocking disk 13 are connected to form a tracheal / esophageal device 10 as a whole by using the connecting member 14 and the waist 12. Figure 4-7 shown.

[0052] In other embodiments, the first sealing disk 11 also includes a coating, which is wrapped around the surface of the first sealing disk 11. The material of the coating can be medical silicone, and the coating is in the form of solid glue when covered on the first sealing disk 11. It can be understood that the coating can be covered on the surface of the first sealing disk 11 by solution dipping, so that the first support member 112 of the first sealing disk 11 is not exposed, and when the first surface 111a of the first sealing disk 11 is applied to the inner wall of the trachea, direct contact between the first support member 112 and the inner wall of the trachea can be avoided. On the other hand, uniform coating of the first sealing disk 11 can be achieved by solution dipping. The setting of the coating will not affect the intervals formed between the multiple first support members 112, and the protrusions formed by the first support members 112 relative to the first surface 111a of the sealing member 111 are retained, so that the cartilage rings of the inner wall of the trachea can be embedded in the intervals between adjacent first support members 112, and the first support members 112 can be correspondingly inserted into the membrane portion between the cartilage rings of the inner wall of the trachea to squeeze the membrane portion and slightly deform it, thereby achieving interlocking sealing between the first sealing disk 11 and the inner wall of the trachea, which can increase the fit, stability and airtightness between the first sealing disk 11 of the trachea / esophageal device 10 and the tracheal wall, and there is no need to further apply glue to seal the fistula.

[0053] The coating method of the silicone coating on the first plugging disk 11 is as follows: first, the connector 14 is passed through the hole in the center of the plugging film layer, and then the first support member 112 and the second support member 113 are fixed to the film layer of the plugging member 111 by suturing or gluing, wherein the intermediate support rod 1123 passes through the connecting groove 1421 of the connector 14, so that the connector 14 is connected to the first plugging disk 11 through the first support member 112, and the connector 14, the first support member 112, the second support member 113 and the plugging film layer fixed as one are placed in the configured silicone solution, and then taken out for drying and baking to solidify the silicone coating. The thickness of the silicone coating can be adjusted by adjusting the insertion time or the number of insertions, wherein the thickness of the coating satisfies: 0.1mm to 0.5mm. The silicone coating is tightly combined with the metal wire or metal rod of the first support member 112 and the second support member 113, and the deformation of the metal support does not affect the integrity of the coating and the support. Since the first support member 112 and the second support member 113 extend in different directions, the first occluding disc 11 is easy to expand in the circumferential direction. At the same time, multiple first support members 112 extend in the first direction and are spaced apart on the first surface 111a, so that the first support member 112 can be correspondingly inserted into the membrane between the cartilage rings of the inner wall of the trachea to squeeze the membrane to deform slightly, thereby achieving the interlocking occlusion between the first occluding disc 11 and the inner wall of the trachea, which can increase the fit, stability and airtightness between the first occluding disc 11 of the trachea / esophagus device 10 and the trachea wall, and there is no need to further apply glue to seal the fistula. At the same time, combined with the cooperation of the second occluding disc 13 and the waist 12, the first occluding disc 11 is pulled and adhered to the inner wall of the trachea at the fistula, so that the first occluding disc 11 of the trachea / esophagus device 10 has better airtightness.

[0054] The present invention also provides a tracheal / esophageal system 100, such as Figure 12-15 As shown, the trachea / esophageal system 100 includes a delivery device 20 and a trachea / esophageal 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 end of the first occluding disk away from the proximal end of the second occluding disk, in one embodiment, the distal end of the delivery cable 21 is detachably connected to the proximal end of the trachea / esophageal 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, so as to facilitate the detachable connection of the distal end of the delivery cable 21 with the proximal end of the trachea / esophageal device 10 through the internal and external threads.

[0055] like Figure 13-15 As shown, the first sealing disk 11 of the tracheal / esophageal device 10 is rolled up in a direction perpendicular to the first support member 112 ( Fig.131) or after stacking the first occluding disc 11, the first supporting member 112 is folded in half, so that the first occluding disc 11 is gathered in the sheath tube 22. In one embodiment, as Fig.13 As shown, the first blocking disk 11 is gradually rolled up toward the middle support rod 1123 from both ends along the second direction (the first direction in the figure is perpendicular to the paper surface) toward the second surface 111b or directly stacked along this direction. The structure of the first blocking disk 11 after rolling up is as shown in FIG. Figure 14-15 As shown, in one embodiment, the blocking film layer is circular, the connector 14 passes through the center of the blocking film layer, the central axis D1 passes through the center of the circle (where the connector 14 is located) and is perpendicular to the first direction, and then the rolled-up first blocking disk 11 is folded in half with the central axis as the folding line, so that the first blocking disk 11 is conveniently gathered in the sheath tube 22 in a state of being folded in half in a direction away from the second blocking disk 13 after being rolled up toward the second surface 111b, as shown in FIG. Fig.12 When assembling the tracheal / esophageal system 100, the connection portion 141 at the proximal end of the tracheal / esophageal device 10 can be firstly connected to the distal end of the delivery cable 21 by threading, and then the second occluding disc 13, the waist portion 12 and the first occluding disc 11 are sequentially gathered in the sheath 22 from the proximal end of the sheath 22, and the tracheal / esophageal device 10 is pushed to the loading position at the distal end of the sheath 22 by the delivery cable 21, thereby achieving the assembly of the tracheal / esophageal device 10. The trachea / esophageal system 100 can deliver the trachea / esophageal device 10 along the trachea to the fistula, from the trachea through the fistula to the esophagus, first withdraw the sheath to release the second occluding disk, so that the second occluding disk is released in the esophagus, and then gradually release the waist, and then pull the whole body so that the second occluding disk is attached to the inner wall of the esophagus, so that the sheath releases the first occluding disk in the trachea, so that the first occluding disk is attached to the inner wall of the trachea, and then rotate the thread of the delivery cable, and withdraw the delivery device to complete the release of the trachea / esophageal device.

[0056] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0057] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A tracheal / esophageal device, characterized in that: The trachea / esophagus device includes a first sealing disk, a waist and a second sealing disk, one end of the waist is connected to the first sealing disk, and the other end of the waist is connected to the second sealing disk, the first sealing disk includes a sealing member and at least two first support members extending along a first direction, two first support members are arranged at intervals from the sealing member, the first sealing disk also includes a second support member extending along a second direction, the first support member and the second support member are used to naturally unfold the sealing member.

2. The tracheal / esophageal device according to claim 1, characterized in that The 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, characterized in that The first support member includes a support rod, and the first support member is arranged on a side of the sealing member close to the second sealing disk; the second support member includes a corrugated structure, and the second support member is arranged on a side of the sealing member away from the second sealing disk.

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

5. The tracheal / esophageal device according to claim 1, characterized in that The first sealing disk includes a central axis, and the central axis passes through the geometric center of the sealing member. The number of the second supporting members is at least one, and any second supporting member does not cross the central axis.

6. The tracheal / esophageal device according to claim 1, characterized in that The projection of the second supporting member and the outermost first supporting member on the blocking member at least partially overlaps.

7. The tracheal / esophageal device according to claim 1, characterized in that Any two of the first supporting members are spanned by the second supporting member at least once.

8. The tracheal / esophageal device according to claim 1, characterized in that The second occluding disk includes a double-layer woven wire mesh disk, and the two ends of the waist are open structures. The woven wires of the second occluding disk are gathered in the opening at one end of the waist near the end of the first occluding disk; the trachea / esophagus device also includes a connecting piece, one end of the connecting piece is placed in the opening at the other end of the waist, the end of the connecting piece away from the second occluding disk passes through the first occluding disk, and the end of the connecting piece passing through the first occluding disk is provided with a connecting portion.

9. The tracheal / esophageal device according to claim 8, characterized in that The connecting member includes a connecting groove, which has the same extension direction as the first supporting member and is arranged on a side of the connecting member close to the second sealing disk, and at least one of the first supporting members passes through the connecting groove.

10. A tracheal / esophageal system, characterized in that: The trachea / esophagus system includes a conveyor and a trachea / esophagus device as described in any one of claims 1 to 9, the conveyor includes 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 first occluding disk away from the second occluding disk, and the first occluding disk is rolled up or stacked in a direction perpendicular to the first support member, and the first support member is folded in half, thereby contracting the first occluding disk within the sheath.

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