A false lumen occlusion device, assembly, and system

Abstract

The application discloses a kind of false cavity plugging device, assembly and system, belong to medical instrument technical field, wherein false cavity plugging device includes elastic membrane and elastic support, elastic support includes warp beam and weft beam, warp beam is continuously bent wave shape, warp beam is equipped with weft beam, and weft beam can be bent into annular ring.Assembly includes release device and false cavity plugging device.System includes conveying device and false cavity plugging assembly, and conveying device includes sheath and guide wire, and sheath is equipped with guide wire passage and conveying passage.Weft beam bends into annular ring can make elastic membrane roll up, reduce the size in width direction, to be contained in sheath, after being separated from sheath, weft beam will be re-opened and contacted with the inner wall of artery dissection, and can be implanted, in the whole process of being received and being separated from sheath, elastic membrane does not have length direction change, and preset release position and actual release position can be kept consistent, reduce the operation requirement to operator, and it is beneficial to popularization and use.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a false cavity occlusion device, component and system. Background Technology

[0002] Currently, the main treatment methods for aortic dissection and aneurysm include traditional open surgery and endovascular aneurysm repair (EVAR). Due to the significant trauma, long recovery period, and high mortality rate of open surgery, patients often prioritize the less invasive and lower-mortality EVAR procedure for abdominal aortic aneurysms, provided they meet the treatment criteria. EVAR surgery primarily uses embolization for closure. For aortic dissection, occlusion devices are implanted into the false lumen to promote embolization, or the distal tear of the dissection is sealed to prevent backflow of blood from the distal tear. Currently, two main types of occlusion devices are used: coils and false lumen occluders.

[0003] Coils are mainly used for embolization of small blood vessels, such as intracranial arteries and peripheral arteries. If coils are used for aortic dissection or aortic aneurysm endoleak, several or even dozens of coils are often required, which has the disadvantages of excessive dosage, complicated operation, and heavy burden on the patient. Moreover, since the outer surface of the coils is not covered, their sealing effect on blood flowing into the false lumen of the aorta is also poor.

[0004] The false lumen occluder is mainly used for the occlusion of aortic dissection and aortic aneurysm endoleak. The false lumen occluder mainly includes a support frame and a sheet-like covering. The sheet-like covering is wavy and bent under the action of the support frame. The wavy and bent section of the covering can effectively block aortic dissection, such as the false lumen occluder disclosed in the patent application number "202211689387.7" entitled "Intraluminal Occluder and Intraluminal Occluder Delivery Device". The main problem with the aforementioned false lumen occluder is that when delivered using a delivery device, it needs to be inserted into the sheath of the device. Because the support frame is composed of multiple ring structures, after being pressed into the sheath, the rings are compressed into an elliptical shape, causing the false lumen occluder to lengthen axially. However, after release from the sheath, it retracts axially. This results in a deviation between the preset release position of the false lumen occluder within the sheath and its actual release position along the long axis of the interlayer, compromising the occlusion effect. Furthermore, the false lumen occluder immediately springs back after release, contacting the inner wall of the false lumen, making its position unadjustable. This requires the operator to anticipate this issue during release, demanding a high level of experience and hindering its widespread adoption. Summary of the Invention

[0005] The purpose of this invention is to solve the above-mentioned technical problems and provide a false lumen occlusion device, component, and system. The weft beam can be bent into a ring, causing the elastic covering membrane to roll up and reducing its width, thus constricting it within the sheath of the delivery device. Upon release, after detaching from the sheath, the weft beam springs back open to contact the inner wall of the arterial dissection, completing the implantation. Throughout the entire process of insertion and removal from the sheath, the weft beam shows virtually no significant change. Therefore, the elastic covering membrane remains essentially unchanged in its length direction, ensuring that the preset release position reached by the sheath and the actual release position of the false lumen occlusion device remain consistent, guaranteeing the occlusion effect, reducing the surgical requirements for the operator, and facilitating widespread use.

[0006] To achieve the above objectives, the present invention provides the following solution: The present invention discloses a false cavity sealing device, comprising an elastic membrane and an elastic support, wherein the elastic membrane is laid out and fixed on the elastic support; the elastic support comprises a warp beam and a weft beam, wherein the warp beam is in a continuously bent wave shape along the length direction of the elastic membrane to divide the elastic membrane into several folded segments along the length direction; the weft beam is provided on at least one crest and trough of the warp beam, the weft beam is arranged along the width direction of the elastic membrane, and the weft beam can be bent into a ring, wherein the axial direction of the ring is perpendicular to the width direction of the elastic membrane.

[0007] Preferably, the weft beam is provided on each crest and trough of the warp beam.

[0008] Preferably, the weft beam is an arc-shaped rod, and the arc openings of two adjacent weft beams face opposite directions, and the weft beam can be bent into a ring along its arc opening direction; the warp beam includes two bent rods arranged side by side.

[0009] Preferably, the elastic support is made of an elastic shape memory alloy, and the elastic coating is made of an elastic polymer material.

[0010] Preferably, the elastic cover includes a single layer or a double layer, wherein the double layer of the elastic cover encloses the elastic support.

[0011] The present invention also discloses a false cavity sealing assembly, including a release device and the aforementioned false cavity sealing device. The release device includes a radial constraint mechanism, which can cause the weft beam to bend into a ring when constrained.

[0012] Preferably, the release device further includes an axial restraint mechanism, which, when restrained, provides a thrust that brings the distal and proximal ends of the elastic support closer together, so that the beam bends further at the crests and troughs.

[0013] Preferably, the radial constraint mechanism includes constraint holes and release wires. The constraint holes are disposed at both ends of each weft beam, and the constraint holes at both ends of the weft beam can overlap each other after the weft beam is bent into a ring. The overlapped constraint holes are used for the release wire to pass through. The axial constraint mechanism includes a distal end, a proximal end, a core rod, and a push tube. The distal end and the proximal end are respectively disposed at the distal and proximal ends of the warp beam. The distal end has a distal radial hole and a distal axial hole that communicate with each other. The distal axial hole is used for the distal end of the core rod to pass through, and the distal end of the core rod has a core rod radial hole. The proximal end and the push tube are both provided with a core rod through hole and a release wire through hole. The distal end of the core rod can sequentially pass through the core rod through hole of the push tube and the core rod through hole of the proximal end; the core rod through hole of the proximal end is provided with a limiting tooth, and the core rod is provided with a stop section, and the stop section is provided with stop teeth arranged along the axial direction of the core rod. With the cooperation of the stop teeth and the limiting teeth, the proximal end can only move from the proximal end to the distal end of the core rod; the push tube is used to push the proximal end toward the distal end; the radial hole of the core rod can correspond to the radial hole of the distal end as the limiting tooth passes through the stop section, so that the distal end of the release wire can pass through; each fold of the elastic membrane is provided with a slit for the core rod to pass through.

[0014] Preferably, both the proximal end and the push tube are provided with two release wire through holes for the two constraint wires to pass through respectively; the weft beam is an arc-shaped rod, and the arc openings of two adjacent weft beams face opposite directions, while the constraint holes of the weft beams with the same bending direction pass through the same release wire.

[0015] The present invention also discloses a false cavity occlusion system, including a delivery device and the above-mentioned false cavity occlusion component. The delivery device includes a sheath and a guide wire. The sheath is provided with a guide wire channel and a delivery channel for the false cavity occlusion component to be filled.

[0016] The present invention achieves the following technical effects compared to the prior art:

[0017] In the false lumen occlusion device of this invention, the elastic stent is mainly composed of a warp beam and a weft beam. The weft beam can be bent into a ring, allowing the elastic covering membrane to roll up in the width direction, reducing its size in that direction. This allows it to be contained within the sheath of the delivery device. During release, the weft beam simply springs back to its original position, achieving contact with the inner wall of the arterial dissection and completing the implantation. Because only the weft beam bends and opens during the entire process of being contained within and released from the sheath, while the warp beam shows no significant change in its extension direction, and consequently the elastic covering membrane remains essentially unchanged in its length direction, the preset release position of the false lumen occlusion device within the sheath and the actual release position of the device dislodged from the sheath are essentially consistent. This ensures the occlusion effect, reduces the surgical requirements for the operator, and facilitates widespread use.

[0018] The other technical solutions of this invention achieve the following technical effects compared to the prior art:

[0019] 1. In this false cavity sealing device, the weft beams are arc-shaped rods and arranged alternately in opposite directions, which makes it easier to fit the inner wall of the false cavity and ensure the sealing effect.

[0020] 2. This false lumen occlusion assembly includes a release device and a false lumen occlusion device. The radial constraint mechanism of the release device ensures that the false lumen occlusion device remains in the bundle diameter state after being detached from the sheath, thus enabling it to move upward along the arterial axis within the arterial dissection. This achieves the position adjustment function of the false lumen occlusion device after detachment from the sheath, enabling secondary adjustment and reducing the positional accuracy requirements when releasing the false lumen occlusion device from the sheath. At the same time, it can solve the problem of inaccurate implantation position due to incomplete initial release or other reasons.

[0021] 3. In this false cavity sealing assembly, the axial constraint mechanism of the release device can adjust the length of the false cavity sealing device after it is detached from the sheath tube, thereby changing the degree of bending at each bending point of the beam, so as to adjust the bulging of each folded section of the elastic membrane and ensure the sealing effect.

[0022] 4. In this false cavity occlusion assembly, the release device includes a core rod, release wire, distal end, proximal end, and push tube. Pushing the push tube forward allows the occlusion devices to stack (under the action of the warp beam, the occlusion devices can form a regular axial stack). After determining the final position, the release wire is pulled out, the weft beam is opened, allowing the occlusion device to fit against the inner wall of the false cavity, and the core rod is withdrawn, completing the implantation of the occlusion device. The final implantation effect is shown in the figure. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained by analyzing these drawings without creative effort.

[0024] Figure 1 This is a three-dimensional structural diagram of the false cavity sealing component in an embodiment of the present invention;

[0025] Figure 2 This is a front view schematic diagram of the false cavity sealing component in an embodiment of the present invention;

[0026] Figure 3 This is a side view of the false cavity plugging assembly (before the false cavity plugging device is released) in an embodiment of the present invention.

[0027] Figure 4 This is a three-dimensional structural diagram of the elastic support in an embodiment of the present invention;

[0028] Figure 5 This is a cross-sectional view of the release device in an embodiment of the present invention;

[0029] Figure 6 This is a schematic cross-sectional view of the distal end in an embodiment of the present invention;

[0030] Figure 7 This is a cross-sectional view of the proximal end, push tube, core rod, and release wire in an embodiment of the present invention.

[0031] Figure 8 This is a three-dimensional structural diagram of the weft beam constrained by the release wire in an embodiment of the present invention;

[0032] Figure 9 This is a cross-sectional view of the distal end, push tube, core rod, and release wire in an embodiment of the present invention.

[0033] Figure 10 This is a schematic cross-sectional view of the proximal end in an embodiment of the present invention;

[0034] Figure 11 This is a cross-sectional view of the core rod before the core rod passes through the hole near the proximal end, according to an embodiment of the present invention.

[0035] Figure 12 This is a cross-sectional view of the core rod after the anti-retraction teeth of the core rod are inserted into the hole near the proximal end of the core rod in an embodiment of the present invention.

[0036] Figure 13 This is a schematic diagram of the structure of the false lumen occlusion device after implantation into an arterial dissection in an embodiment of the present invention.

[0037] Explanation of reference numerals in the attached figures:

[0038] 1. Elastic endovascular membrane; 2. Elastic stent; 3. Distal tip; 4. Proximal tip; 5. Core rod; 6. Push tube; 7. Release wire; 8. Aortic dissection;

[0039] 11. Folded section;

[0040] 21. Warp beam; 22. Weft beam; 23. Restriction hole;

[0041] 31. Distal radial hole; 32. Distal axial hole;

[0042] 41. Core rod passes through the hole; 42. Release wire passes through the hole; 43. Limiting teeth;

[0043] 51. Core rod radial hole; 52. Anti-reverse tooth. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments analyzed and obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] The purpose of this invention is to provide a false lumen occlusion device, component, and system to address the problems existing in the prior art. The elastic stent is mainly composed of warp beams and weft beams, wherein the weft beams can be bent into a ring, allowing the elastic covering membrane to roll up in the width direction, reducing its size in that direction, and thus constricting it within the sheath of the delivery device. During release, the weft beams simply spring back to their original position, achieving contact with the inner wall of the arterial dissection and completing the implantation. Throughout the process of constriction into the sheath and release from the sheath, the elastic covering membrane does not change in the length direction. Therefore, the preset release position reached by the sheath and the actual release position can remain consistent, ensuring the occlusion effect, reducing the surgical requirements for the operator, and facilitating its widespread use.

[0046] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0047] Example 1

[0048] like Figures 1 to 13As shown, this embodiment provides a false cavity sealing device, including an elastic membrane 1 and an elastic support 2. The elastic membrane 1 is laid out and fixed on the elastic support 2. The elastic support 2 includes a warp beam 21 and a weft beam 22. The warp beam 21 is in a continuously bent wave shape along the length direction of the elastic membrane 1 to divide the elastic membrane 1 into several folded segments 11 along the length direction. A weft beam 22 is provided on at least one crest and trough of the warp beam 21. The weft beam 22 is arranged along the width direction of the elastic membrane 1 and can be bent into a ring, with the axis of the ring perpendicular to the width direction of the elastic membrane 1.

[0049] Working principle:

[0050] The elastic stent 2 of this false lumen occlusion device mainly consists of a longitudinal beam 21 and a latitudinal beam 22. The latitudinal beam 22 can be bent into a ring, allowing the elastic diaphragm 1 to roll up in the width direction, reducing its size and thus constricting it within the sheath of the delivery device. During release, the latitudinal beam 22 simply springs back into place, achieving contact with the inner wall of the aortic dissection 8 and completing the implantation. Throughout the entire process of constriction into the sheath and release from the sheath, the longitudinal beam 21 does not significantly change in its extension direction, i.e., the length direction of the elastic diaphragm 1. Therefore, the elastic diaphragm 1 can be considered essentially unchanged in its length direction. Consequently, the preset release position of the false lumen occlusion device within the sheath and the actual release position of the false lumen occlusion device after dislodgement from the sheath can remain consistent, ensuring the occlusion effect, reducing the surgical requirements for the operator, and facilitating its widespread use.

[0051] In one embodiment, a weft beam 22 is provided on each crest and trough of the warp beam 21.

[0052] In one embodiment, the weft beam 22 is an arc-shaped rod, with the arc openings of adjacent weft beams 22 facing opposite directions, arranged alternately in opposite directions along the length of the elastic membrane 1. The weft beam 22 can be bent into a ring along its arc opening direction. The warp beam 21 includes two bent rods, which are arranged side by side on the elastic membrane 1. Preferably, in their natural state, the straight-line distance between each bending point of the bent rods is equal, so that in their natural state, the positions of adjacent weft beams 22 are equal.

[0053] In one embodiment, the elastic support 2 is made of an elastic shape memory alloy. The elastic coating 1 is made of an elastic polymer material, such as TPU (Thermoplastic polyurethanes) or PET (Polyethylene terephthalate).

[0054] In one embodiment, a single-layer or double-layer elastic film 1 is included. When a single-layer elastic film 1 is used, it can be fused together with the elastic support 2, and the material is typically TPU. When a double-layer elastic film 1 is used, the double-layer elastic film 1 wraps around the elastic support 2, and the elastic film 1 is typically made of PET.

[0055] Example 2

[0056] like Figures 1 to 13 As shown, this embodiment provides a false cavity sealing assembly, including a release device and the false cavity sealing device in Embodiment 1. The release device includes a radial constraint mechanism. The radial constraint mechanism can bend the weft beam 22 into a ring when constrained.

[0057] Working principle:

[0058] First, the various weft beams 22 of the false lumen occlusion device are bent into rings, and then the radial constraint mechanism of the release device maintains the ring shape of the weft beams 22. Next, the false lumen occlusion assembly (false lumen occlusion device and release device) is inserted into the sheath of the delivery device. Then, using the guide wire and sheath, the false lumen occlusion assembly is released to the preset release position, and the sheath is withdrawn. At this time, due to the constraint of the radial constraint mechanism, the weft beams 22 will not unfold, and the false lumen occlusion device can still move within the aortic dissection 8. Finally, after adjusting the position of the false lumen occlusion device to ensure that it is accurately located at the preset release position, the release device is released. Without the constraint of the radial constraint mechanism, the weft beams 22 rebound under the action of elastic restoring force, opening the elastic diaphragm 1 and realizing the occlusion of the aortic dissection 8.

[0059] This false lumen occlusion assembly includes a release device and a false lumen occlusion device. After being released from the sheath, the false lumen occlusion device is still constrained radially (in the width direction of the elastic diaphragm 1), thereby enabling the false lumen occlusion device to move upward along the arterial axis within the aortic dissection 8. This allows for secondary adjustment of the position of the false lumen occlusion device within the aortic dissection 8, reducing the positional accuracy requirements when releasing the false lumen occlusion device from the sheath. It also solves the problem of inaccurate implantation position due to incomplete initial release or other reasons.

[0060] The radial restraint mechanism can use another sheath as the restraint tube. After the false cavity sealing device is inserted into the restraint tube, the restraint tube is placed into the outer sheath. Pulling the restraint tube out of the false cavity sealing device achieves secondary release. Alternatively, a restraint wire and a limiting wire can be used in combination. The restraint wire is spirally wound around the outside of the false cavity sealing device, and the limiting wire passes through the spiral restraint wire, with both ends of the limiting wire extending outside the body. By pulling one end of the limiting wire, the other end of the limiting wire is pulled out of the spiral restraint wire. After the spiral restraint wire is no longer restrained by the limiting wire, pulling the restraint wire further causes it to detach from the false cavity sealing device. The false cavity sealing device is then freed from the restraint wire, achieving secondary release. In addition, a specially designed release device can be used, which is described below.

[0061] In one embodiment, the release device further includes an axial constraint mechanism. When constrained, the axial constraint mechanism can provide a thrust that brings the distal and proximal ends of the elastic support 2 closer together, so that the warp beam 21 bends further at the crests and troughs, thereby adjusting the degree of bending of the warp beam 21, adjusting the degree of bending of the elastic covering 1, and adjusting the stacking of its folded sections 11 to avoid messy stacking, small sealing range, and ensure sealing effect.

[0062] In one embodiment, a release device specifically designed for releasing the false cavity sealing device of Embodiment 1 is provided. This release device includes a radial constraint mechanism and an axial constraint mechanism.

[0063] The radial constraint mechanism includes a release wire 7 and constraint holes 23, with the constraint holes 23 located at both ends of each weft beam 22. The constraint holes 23 at both ends of the weft beam 22 can overlap after the weft beam 22 is bent into a ring, allowing the release wire 7 to pass through and thus constraining the ring formed by the weft beam 22. The release wire 7 is made of a rigid wire, such as a metal wire.

[0064] The axial restraint mechanism includes a distal end 3, a proximal end 4, a core rod 5, and a push tube 6. The distal end 3 is fixed to the distal end of the beam 21, and the proximal end 4 is fixed to the proximal end of the beam 21. The distal end 3 has a distal radial hole 31 and a distal axial hole 32 that are interconnected. The distal axial hole 32 is used for the distal end of the core rod 5 to pass through. The distal end of the core rod 5 has a core rod radial hole 51, which corresponds to the distal radial hole 31, for the distal end of the release wire 7 to pass through. Both the proximal end 4 and the push tube 6 have core rod through holes and release wire through holes. The distal end of the core rod 5 can pass through the core rod through hole 41 of the proximal end 4 via the core rod through hole of the push tube 6. The release wire 7 can pass through the release wire through hole 42 of the proximal end 4 in sequence. A limiting tooth 43 is provided inside the core rod through hole 41 of the proximal end 4. The core rod 5 is provided with a backstop section, and the backstop section is provided with multiple backstop teeth 52, which are arranged along the axial direction of the core rod 5. With the cooperation of the backstop teeth 52 and the limiting teeth 43, the proximal end 4 can only move from the proximal end to the distal end of the core rod 5. By changing the axial position of the limiting teeth 43 in the backstop section of the core rod 5, the degree of folding at each folding point of the beam 21 can be adjusted, and the degree of bulging of each folding segment 11 of the elastic membrane 1 can be adjusted. The push tube 6 is used to push the proximal end 4 toward the distal end 3; the radial hole 51 of the core rod can correspond to the distal radial hole 31 during the process of the limiting tooth 43 passing through the anti-reverse section, so that the distal end of the release wire 7 can pass through. Preferably, when the setting is made, the limiting tooth 43 can pass through the last anti-reverse tooth 52 of the proximal end of the anti-reverse section and contact the smooth surface of the core rod 5, so that the radial hole 51 of the core rod corresponds exactly to the distal radial hole 31. Of course, it is also possible that the limiting tooth 43 can pass through a certain limiting tooth 43 within the range of the anti-reverse section, so that the radial hole 51 of the core rod corresponds exactly to the distal radial hole 31. Each folded section 11 of the elastic film 1 is provided with a slit for the core rod 5 to pass through. Preferably, the slit is located on the center line of the width direction of each folded section 11.

[0065] In one embodiment, both the proximal end 4 and the push tube 6 are provided with two release wire through holes. There are two release wires 7 in total, which must pass through the two release wire through holes of the push tube 6 and the release wire through hole 42 of the proximal end 4 respectively when in use. The weft beam 22 is an arc-shaped rod, and the arc openings of two adjacent weft beams 22 face opposite directions. Weft beams 22 with the same arc opening direction form a group, which in turn divides the weft beams 22 into two groups with opposite directions. The constraint holes 23 of the weft beams 22 with the same bending direction pass through the same release wire 7.

[0066] Working principle:

[0067] ① Preoperative assembly:

[0068] First, the proximal end of the core rod 5 is sequentially passed through the distal axial hole 32 of the distal end 3, the slits on the folded section 11 of the elastic membrane 1, the core rod through hole 41 of the proximal end 4, and the core rod through hole of the push tube 6. Then, the proximal end of the core rod 5 is pulled back so that the anti-retraction section of the core rod 5 is inserted into the core rod through hole 41 of the proximal end 4. Preferably, one or more limiting teeth 43 at the proximal end of the anti-retraction section can pass over the limiting teeth 43 first to complete the locking of the core rod 5 and the proximal end 4.

[0069] Then, the distal ends of the two release wires 7 are sequentially passed through the two release wire through holes 42 of the push tube 6 and the two release wire through holes 42 of the proximal end 4. The forward-facing weft beam 22 is bent, and the constraint holes 23 at both ends of the weft beam 22 overlap axially during bending. The distal end of one of the release wires 7 is sequentially passed through the constraint holes 23 of all the forward-bent weft beams 22, and inserted through one end of the distal axial hole 32 of the distal end 3. Then, the reverse-facing weft beam 22 is bent... Bending, the distal end of another release wire 7 is passed through the constraint holes 23 of all the reverse-bent weft beams 22 in sequence, and then inserted through the other end of the distal axial hole 32 of the distal end 3. Then the position of the core rod 5 is adjusted so that the core rod radial hole 51 of the core rod 5 is aligned with the distal axial hole 32. Then the distal ends of the two release wires 7 are inserted into the core rod radial hole 51 to complete the locking of the core rod 5 and the distal end 3. Thus, the radial and axial constraints of the elastic bracket 2 are completed, and the false cavity sealing assembly is assembled.

[0070] Finally, the false cavity sealing assembly is inserted into the delivery channel of the sheath.

[0071] ②Used during the procedure:

[0072] First, the sheath of the delivery device is inserted into the aortic dissection 8 under the guidance of the guidewire. The position of the sheath is adjusted so that the false lumen occlusion device of the false lumen occlusion assembly is initially in the preset release position.

[0073] Then, retract the sheath tube to disengage the false cavity sealing device from the sheath tube, and then pull the core rod 5 to adjust the position of the false cavity sealing device so that it corresponds to the preset release position;

[0074] Then, push the push tube 6 toward the far end, so that the far end of the push tube 6 pushes the far end of the proximal end 4, so that the proximal end 4 moves along the core rod 5 toward the far end 3, reducing the axial position of the limiting tooth 43 of the proximal end 4 on the anti-reverse section of the core rod 5. Under the pressure of the beam 21, the degree of folding of the folding point of the beam 21 increases, and the degree of bulging of the folding section 11 of the elastic covering film 1 increases. Whether to adjust and the degree of adjustment are determined according to the actual situation.

[0075] Next, pull back the two release wires 7 to remove them. The weft beam 22, which is no longer constrained by the release wires 7, opens naturally, and the folded segment 11 of the elastic cover 1 opens naturally and contacts the inner wall of the aortic dissection 8 to complete the positioning. Then, pull back the core rod 5 to remove the proximal end 4, thus completing the release of the false lumen occlusion device and the implantation of the false lumen occlusion device to seal the aortic dissection 8.

[0076] Finally, the sheath, guidewire, core rod 5, and push tube 6 can be withdrawn. Because the elastic membrane 1 is elastic, after the core rod 5 is withdrawn from each slit, the slits will automatically close under the elastic tension. The slits cannot be reopened by the impact force of blood alone, so there is no need to worry about blood flowing out from the slits.

[0077] Example 3

[0078] like Figures 1 to 13 As shown, this embodiment provides a false lumen occlusion system, including a delivery device and a false lumen occlusion assembly as in Embodiment 2. The delivery device includes a sheath and a guidewire. The sheath has a guidewire channel and a delivery channel. The guidewire passes through the delivery channel and can be lowered into the sheath through the guidewire. The delivery channel is used to fill the false lumen occlusion assembly and carry the false lumen occlusion assembly to the aortic dissection 8. The working principle is as described above.

[0079] The present invention has the following advantages over the prior art:

[0080] 1. Compared with existing spring coil technology, this false cavity occlusion device is more convenient to use, eliminating the need for multiple implantation of prostheses into the false cavity (which often requires multiple, even a dozen or twenty, prostheses when using spring coil embolization), saving surgical time, reducing patient bleeding, and lowering the patient's financial burden.

[0081] 2. Compared with existing blocking devices, this false cavity blocking component and system has a beam diameter function. After the false cavity blocking device is pushed out of the sheath, it is not fully deployed and the release position can be adjusted within the false cavity.

[0082] 3. Compared with existing sealing devices, the weft beam 22 is an arc-shaped rod and is arranged alternately in opposite directions, which makes it easier to fit the inner wall of the false cavity. The beam 21 is folded as a whole and has elasticity, so that the spacing of the weft beam 22 remains consistent during the axial compression of the false cavity sealing device.

[0083] 4. Compared with existing blocking devices, this false cavity blocking component and system is easy to stack, release and withdraw. Push the push tube 6 to stack the device, pull out the release wire 7 and retract the core rod 5.

[0084] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A false cavity sealing device, characterized in that: The device includes an elastic diaphragm and an elastic stent. The elastic diaphragm is laid out and fixed on the elastic stent. The elastic stent includes warp beams and weft beams. The warp beams are continuously bent in a wave shape along the length of the elastic diaphragm to divide the elastic diaphragm into several folded segments along the length direction. At least one crest and trough of the warp beams are provided with the weft beams. The weft beams are arranged along the width direction of the elastic diaphragm and can be bent into a ring so that the elastic diaphragm can be contained within the sheath of the delivery device. The axis of the ring is perpendicular to the width direction of the elastic diaphragm. Upon release, the weft beams need to spring back to their original position and contact the inner wall of the aortic dissection. The weft beams are arc-shaped rods with the arc openings of two adjacent weft beams facing opposite directions. The weft beams can be bent into a ring along their arc opening directions. The warp beams include two bent rods arranged side by side.

2. The false cavity sealing device according to claim 1, characterized in that: The warp beam is provided on each crest and trough of the warp beam.

3. The false cavity sealing device according to claim 1 or 2, characterized in that: The elastic support is made of elastic shape memory alloy, and the elastic coating is made of elastic polymer material.

4. The false cavity sealing device according to claim 1 or 2, characterized in that: The elastic cover may be a single layer or a double layer, wherein the double layer of the elastic cover encloses the elastic support.

5. A false cavity sealing assembly, characterized in that: It includes a release device and a false cavity sealing device as described in any one of claims 1-4, wherein the release device includes a radial constraint mechanism that, when constrained, enables the weft beam to bend inward into a ring.

6. The false cavity sealing assembly according to claim 5, characterized in that: The release device also includes an axial restraint mechanism, which, when restrained, can provide a thrust that brings the distal and proximal ends of the elastic support closer together, so that the beam bends further at the crests and troughs.

7. The false cavity sealing assembly according to claim 6, characterized in that: The radial constraint mechanism includes constraint holes and release wires. The constraint holes are disposed at both ends of each weft beam. The constraint holes at both ends of the weft beam can overlap each other after the weft beam is bent into a ring. The overlapped constraint holes are used for the release wire to pass through. The axial restraint mechanism includes a distal end, a proximal end, a core rod, and a push tube. The distal end and the proximal end are respectively located at the distal and proximal ends of the beam. The distal end has a distal radial hole and a distal axial hole that communicate with each other. The distal axial hole is used for the distal end of the core rod to pass through, and the distal end of the core rod has a core rod radial hole. Both the proximal end and the push tube have core rod through holes and release wire through holes. The distal end of the core rod can pass through the core rod through hole of the push tube and the core rod through hole of the proximal end in sequence. The core rod of the head has a limiting tooth inside the through hole, and the core rod has a stop section with stop teeth arranged along the axial direction of the core rod. With the cooperation of the stop teeth and the limiting teeth, the proximal end can only move from the proximal end of the core rod to the distal end. The push tube is used to push the proximal end toward the distal end. The radial hole of the core rod can correspond to the radial hole of the distal end as the limiting teeth pass through the stop section, so that the distal end of the release wire can pass through. Each fold of the elastic membrane has a slit for the core rod to pass through.

8. The false cavity sealing assembly according to claim 7, characterized in that, Both the proximal end and the push tube are provided with two release wire through holes for the two release wires to pass through respectively; the weft beam is an arc-shaped rod, and the arc openings of two adjacent weft beams face opposite directions, while the constraint holes of the weft beams with the same bending direction pass through the same release wire.

9. A false cavity sealing system, characterized in that: The device includes a delivery device and a false lumen occlusion assembly as described in any one of claims 6-8. The delivery device includes a sheath and a guide wire, wherein the sheath is provided with a guide wire channel and a delivery channel for filling the false lumen occlusion assembly.

Images