A closure system with a split support structure

Abstract

The application relates to the field of medical devices, in particular to a closure system with a split support structure, comprising a support recovery system, a first delivery system and a second delivery system, wherein the support recovery system comprises a split support structure and a pulling assembly, the split support structure comprises a support structure and a capturing member, and the two are detachably connected; the first delivery system and the second delivery system are configured to deliver a first connecting member and a second connecting member through two pieces of tissue to be closed respectively, and the distal end of the first connecting member and / or the distal end of the second connecting member is connected with the capturing member.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a closure system with a split support structure. Background Art

[0002] The foramen ovale is a physiological passageway in the atrial septum during the embryonic period. The fetus lacks pulmonary circulation, so oxygenated blood from the umbilical cord flows from the right atrium through the foramen ovale into the left atrium. After birth, as pulmonary circulation establishes, left atrial pressure increases, and the septum secundum and septum primum converge, fuse, and eventually form a permanent atrial septum. However, in some cases, this fusion still occurs, resulting in a patent foramen ovale (PFO). Traditionally, surgical treatment for a PFO is surgical. Surgical treatment requires a thoracotomy. The main disadvantages of surgery are: the need for extracorporeal circulation, the potential for complications and death, the high trauma and scarring, and the high cost. With the advancement of interventional technology, minimally invasive techniques for treating PFO have become highly established. Minimally invasive interventions offer advantages such as no surgery, minimal trauma, fewer complications, faster recovery, better results, a wide range of indications, and relatively low costs. However, these procedures often present challenges.

[0003] Patent CN202210863123.2 discloses a device for closing tissue, which completes the closure of the foramen ovale tissue by connecting a first support body and a second support body with a suture. However, this design still has the following defects: first, the shape of the lesion of each patient is different, and it is impossible to ensure that the first support rod and the second support rod are in close contact with the tissue. Moreover, since the support rod and the flow-blocking membrane cover each other, the support rod is a metal implant, which easily leaves a gap between the flow-blocking membrane and the cardiac tissue, which is not conducive to endothelialization. Second, the suture passes through the first connecting part and the second connecting part in a back-and-forth movement, and a suture passes through the secondary septum and the primary septum. It is extremely difficult to achieve this movement in such a small space. Moreover, the fitting of the disc-shaped first support body and the second support body is achieved by fixing the first connecting part and the second connecting part in the center. The fitting effect is worrying, and the middle fastening cannot ensure the close contact of the peripheral part, and the risk of bleeding is still very high.

[0004] In summary, the existing technology has the following problems that urgently need to be solved: first, the problem that the metal implant affects the adhesion between the flow-blocking membrane and the tissue; second, the operational difficulty of puncturing or suturing the secondary septal tissue and the primary septal tissue back and forth; and third, the problem that by fixing the center of the occluder disc, it is impossible to ensure that the peripheral part will not leak blood. Summary of the Invention

[0005] This application is proposed in view of the above and other more concepts.

[0006] One of the purposes of the present application is to overcome the deficiencies of the prior art, and to provide a closure system with a split support structure.

[0007] The purpose of the present application is achieved by the following solutions:

[0008] A closure system with a split support structure, comprising a support recovery system, a first delivery system and a second delivery system, the support recovery system comprising a split support structure and a pulling assembly, the split support structure comprising a support structure and a capturing member, both being detachably connected, the first delivery system and the second delivery system being configured to deliver a first connecting member and a second connecting member through two pieces of tissue to be closed respectively, and the distal end of the first connecting member and / or the distal end of the second connecting member being connected with the capturing member.

[0009] The purpose of the present application can also be further achieved by the following technical solutions:

[0010] Further, after the first connecting member and the second connecting member are connected with the capturing member, the support structure is separated from the capturing member, and the pulling assembly pulls the support structure to recover it to the outside of the body.

[0011] Further, the support structure supports the tissue to be closed when the first delivery system and the second delivery system pass through the tissue to be closed.

[0012] Further, the capturing member and the distal end of the first connecting member and the distal end of the second connecting member are located at the distal end surface of the tissue to be closed after implantation.

[0013] Further, the capturing member is attached to the distal end surface of the tissue to be closed.

[0014] Further, the capturing member and the distal end or distal part of the first connecting member and the distal end or distal part of the second connecting member form a closed loop at the distal end surface of the tissue to be closed.

[0015] Further, the first delivery system can deliver a plurality of first connecting members through the secondary septum tissue.

[0016] Further, the second delivery system can deliver a plurality of second connecting members through the oval foramen tissue.

[0017] Further, the support recovery system comprises a recovery outer sheath, and the split support structure and the pulling assembly are pre-installed in the recovery outer sheath.

[0018] Further, the pulling assembly comprises a channel adapting member and an auxiliary clamping structure, the auxiliary clamping structure is movably connected to the channel adapting member; and the auxiliary clamping structure is attached to the proximal surface and the distal surface of the tissue to be closed respectively.

[0019] Further, the channel adapting member is connected to the center of the supporting structure.

[0020] Further, the channel adapting member is movably connected to the supporting structure.

[0021] Further, the capturing member comprises a first unit and a second unit, the first unit is disc-shaped, the second unit is ring-shaped, and the two are connected at the outer peripheral edge; and the overlapping part of the first unit and the second unit forms a placement space.

[0022] Further, the placement space is in the shape of a pouch.

[0023] Further, the supporting structure comprises a plurality of radially arranged supporting rods; and the outer peripheral part of the supporting structure is preloaded in the placement space.

[0024] Further, the supporting rods are made of nickel-titanium alloy material.

[0025] Further, the first conveying system comprises a first puncture tube, the second conveying system comprises a second puncture tube, and the first connecting member and the second connecting member are preloaded in the first puncture tube and the second puncture tube respectively.

[0026] Further, the puncture points of the first puncture tube and the second puncture tube are arranged in the overlapping area of the first unit and the second unit.

[0027] Further, the overlapping area is disc-shaped.

[0028] Further, the split supporting structure comprises a control member and a connecting coil, the connecting coil is arranged on the proximal surface of the capturing member and the distal surface of the supporting structure, the control member passes through the connecting coil arranged on the capturing member and the supporting structure, and the supporting structure and the capturing member form a connecting relationship.

[0029] Further, the connecting coil is arranged radially or circumferentially on the surface of the capturing member.

[0030] Further, the supporting structure is arranged at least partially on the distal surface of the capturing member; and the center of the capturing member is provided with a withdrawal channel, and the supporting structure and the control member pass through the withdrawal channel in the preloaded state of the split supporting structure.

[0031] Furthermore, after the control member is withdrawn from the withdrawal channel, the support structure is withdrawn from the withdrawal channel; and after both are withdrawn, the withdrawal channel is automatically closed.

[0032] Furthermore, the control member is a metal wire.

[0033] Furthermore, the control member is arranged inside the channel adapter.

[0034] Furthermore, the first connecting member includes a first vertical member and a first pull wire, and the second connecting member includes a second vertical member and a second pull wire; and the first vertical member and the second vertical member are connected to the distal surface of the capture member after implantation.

[0035] Furthermore, the first vertical member is parallel to the first puncture tube when pre-installed on the first puncture tube; and the first vertical member is parallel to the surface of the capture member after being separated from the first puncture tube.

[0036] Furthermore, the first vertical member and the second vertical member are made of polymer material or metal material; and the second vertical member of the first vertical member has a harderness than the first pull wire and the second pull wire.

[0037] Furthermore, it also includes a proximal locking system, which includes a locking structure and a cutting structure.

[0038] Furthermore, the locking structure is used to fix the first connecting member and the second connecting member located on the proximal surface of the tissue to be closed.

[0039] Furthermore, the cutting structure shears the first connecting member portion and the second connecting member portion located at the proximal end of the locking structure.

[0040] Furthermore, the locking structure is in the shape of a bolt head.

[0041] Furthermore, the locking structure is in a sheet shape, and the locking structure and the capturing member are made of the same elastic porous material.

[0042] Furthermore, the locking structure is disc-shaped and is made of a film material.

[0043] Furthermore, the locking structure is adhered to the right atrial surface of the foramen ovale, and the locking structure and the heart tissue are endothelialized.

[0044] Furthermore, the locking structure further includes a connecting piece, and the connecting piece is connected to the first pull wire and the second pull wire located on the proximal surface of the tissue to be closed.

[0045] Furthermore, the capturing member is a laminating film or a felt sheet.

[0046] Furthermore, the capturing member is in a strip shape.

[0047] Furthermore, the capture member includes reinforcing ribs, which play a shaping role in forming the unfolded disk surface.

[0048] Furthermore, the capturing element is an elastic or shape memory film.

[0049] Furthermore, when the support structure and the capture member are connected, the support structure stretches out the capture member. After the two are disassembled, the capture member retracts and tightens, which plays a role of suturing and tightening to a certain extent.

[0050] Furthermore, the capture member is arranged on the distal end surface of the support structure, and such a design facilitates the withdrawal of the support structure.

[0051] Furthermore, an upper portion of the support structure is arranged on a proximal end surface of the capture member, and a lower portion of the support structure is arranged on a distal end surface of the capture member.

[0052] Furthermore, the reinforcing ribs are made of polymer material.

[0053] Furthermore, the reinforcing rib is made of nickel-titanium alloy material.

[0054] Furthermore, the locking structure enters the right atrium along the first pull wire and the second pull wire.

[0055] Furthermore, the support recovery system enters the right atrium through the femoral vein to the foramen ovale tissue, then operates the recovery outer sheath to release the split support structure in the left atrium, releases the traction component in the foramen ovale channel and the right atrium, and then withdraws the recovery outer sheath.

[0056] Furthermore, the first delivery system includes an abutment structure, a first loading tube and a first puncture tube, and the first puncture tube is pre-installed in the first loading tube.

[0057] Furthermore, the distal end of the first loading tube is movably connected to the abutment structure.

[0058] Furthermore, the first delivery system and the second delivery system are operated to enter the right atrium, and the pulling assembly is pulled so that the support structure and the split support structure are in contact with the left atrial surface. Then, the push rod is operated to reach the target position, and the first loading tube is pushed so that the elastic part is in close contact with the proximal surface of the secondary septum until the distal end of the first loading tube is perpendicular to the elastic part, and the first puncture tube is pushed to puncture the secondary septum.

[0059] Furthermore, the second puncture tube is pushed to puncture the secondary septal tissue.

[0060] Further, the first delivery system and the second delivery system are recovered; and the recovery sheath is operated to enter the right atrium, and the pulling assembly is pulled to recover the support structure.

[0061] Further, the proximal locking system is operated to enter the right atrium along the first pull wire and the second pull wire, and the advancement of the locking structure causes the two pieces of tissue to be closed until the locking structure can no longer move distally, and the fastening action is completed.

[0062] Further, the capturing member is elastic, and the support structure is arranged in the placement space, and the capturing member is expanded.

[0063] Further, the treatable indications of the capturing member include patent foramen ovale problems and atrial septal defect problems.

[0064] Compared with the prior art, the technical scheme of the present application has at least the following advantages:

[0065] 1. In the prior art, in order to achieve the closure of the foramen ovale tissue, a metal piece is often used for plugging or support, but the implantation of the metal piece will affect the fitting effect and cause adverse reactions, and the existing suture device usually needs to be passed back and forth multiple times, or needs to pass through the secondary septum and the primary septum tissue at the same time, which is difficult to operate and causes great damage to the tissue. The technical scheme of the present application solves the above problems. First, the present application designs a split support structure, which provides support for tissue puncture. The first delivery system and the second delivery system are arranged on the other side of the split support structure to abut against each other. At the same time, in order to reduce the influence of the metal implant, the support structure of the split support structure is removed from the body after completing the support function, and only the capturing member is left to fit the foramen ovale tissue. As a result, there is no metal implant or only a small amount of metal implant on the left atrial surface of the foramen ovale, which avoids adverse reactions caused by metal ions and promotes the process of endothelialization. On the other hand, since the first delivery system and the second delivery system pass through the two pieces of tissue to be closed respectively, i.e., pass through the secondary septum tissue and the primary septum tissue respectively, a pipe or element is not needed to pass through the secondary septum tissue and the primary septum tissue at the same time. The puncture action is simple and easy to implement, and the success rate of the operation is high.

[0066] 2. Different from the prior art, only the capturing member and the connecting member are left at the lesion site after implantation. Compared with the simple suture method, the left atrial surface covered by the capturing member is large, and the closure effect is good. Compared with the double-disc structure, the metal implant is extremely low, which is convenient for the patient to recover. Moreover, since the capturing member is made of flexible material, it has good compliance. On the other hand, if the patient's heart has other lesions, such as mitral regurgitation, the operator can still perform puncture through the atrial septum tissue, which does not affect the secondary intervention.

[0067] 3. Different from the prior art, the capture member is arranged on the left atrial surface, and the action point or fixed point of the capture member depends on the puncture position. The puncture position is controlled by the surgeon. The surgeon can select the puncture position according to the shape of the patient's foramen ovale, and can also decide the number of first connecting members and second connecting members to be delivered according to the surgical situation. The puncture point of the present application is generally selected at the center position of the secondary septal tissue and the primary septal tissue, and is fixed at at least two or three points, so that the capture member maintains a good fitting posture, which is better than the occlusion scheme of only suturing at the center and having only one fixed point. Therefore, the closure system of the present application can adapt to foramen ovale tissues of different shapes without excessively correcting the original morphology of the tissue, and is more humane.

[0068] 4. Different from the existing technology, the support structure includes radially arranged support rods. The advantages of this arrangement are: it does not occupy excessive space and will not interfere with the first puncture tube or the second puncture tube; and when the first connecting member or the second connecting member is connected to the capture member, the support structure will not interfere with the first connecting member or the second connecting member when it is retracted. The support structure and the capture member are separated naturally, and the release of the two is very convenient, which is convenient for the operator to operate.

[0069] 5. Different from the prior art, the traction assembly of the present application includes a channel adapter, which has a certain rigidity and can support the secondary septal tissue and the primary septal tissue at the same time during the operation. When the first puncture tube is punctured, it can cooperate with the support structure to better rest against the distal surface of the secondary septal tissue. When the second puncture tube is punctured, it plays the function of limiting and fixing the primary septal tissue, thereby ensuring the stable puncture of the primary septal tissue. In addition, the size of the channel adapter is smaller than that of the support structure after recovery, and will not expand the size of the recovered outer sheath.

[0070] 6. Different from the prior art, the capture member of the present application is an elastic membrane, which is in an expanded state when connected to the support structure. When the two are separated, the elastic membrane shrinks and tightens to restore to a preset shape. During the shrinkage process, it can assist the secondary septum and the primary septum tissue to approach or close, and the fitting and closing effects are good.

[0071] 7. Different from the existing technology, the support structure of the present application is arranged on the distal surface of the capture piece. This design enables the capture piece to completely fit with the foramen ovale tissue on the left atrial surface, ensuring the puncture effect. Puncture when the capture piece is in contact can ensure that the puncture point on the capture piece is not enlarged, and the puncture tube is also withdrawn very smoothly, which is convenient for improving the success rate of the operation.

[0072] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below; and they can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent and the embodiments of the present application can be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0074] Figures 1 to 11 Schematic diagram and principle diagram of the operation process of the closed system in Example 1 of the present invention.

[0075] Figures 12-14 Schematic diagram of the structure of the capture element in embodiment 1 of the present invention

[0076] Figure 15 This is a schematic structural diagram of the support structure in Example 1 of the present invention.

[0077] Figure 16 Schematic diagram of the principle of the first loading tube rotating relative to the abutting structure in the first embodiment of the present invention.

[0078] Figure 17 This is a schematic diagram of a pulling assembly including an auxiliary clamping structure in a second embodiment of the present invention.

[0079] Figure 18 Another embodiment of the present invention is to separate the support structure and the capture member.

[0080] Figure 19 This is another embodiment of the locking structure of the present invention.

[0081] Figure 20 and 21 This is an embodiment of the present invention in which the capturing member is an elastic film.

[0082] Figures 22-25 This is another embodiment of the split support structure of the present invention.

[0083] The features indicated by the numbers in the accompanying drawings are as follows:

[0084] 1-Support recovery system, 11-Recovery outer sheath, 2-Split support structure, 21-Support structure, 211-Support rod, 22-Capture component, 221-First unit, 222-Second unit, 223-Placement space, 224-Overlap area, 23-Control component, 24-Connection coil, 25-Retraction channel, 3-Pulling component, 31-Channel adapter, 32-Pulling component, 33-Auxiliary clamping structure, 4-First delivery system, 41-First connecting component, 41 1-first vertical member, 412-first pull wire, 42-first puncture tube, 43-aft structure, 431-elastic part, 432-opening, 433-top rod, 434-metal connecting wire, 44-first loading tube, 441-matching part, 5-second conveying system, 51-second connecting part, 511-second vertical member, 512-second pull wire, 52-second puncture tube, 6-proximal locking system, 61-locking structure, 611-connecting part, 62-resection structure. DETAILED DESCRIPTION

[0085] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0086] It should be understood that the phrases and terms used herein are for descriptive purposes only and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0087] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0088] In the present application, the term “proximal end” or “proximal side” refers to an end or side closer to a surgical operator, and “distal end” or “distal side” refers to an end or side farther from a surgical operator.

[0089] In the prior art, there are problems such as poor closure effect caused by the support structure and the capture member being connected and remaining together in the heart, and the problem of metal particles affecting the patient.

[0090] One purpose of the embodiments described below is to address the above-mentioned drawbacks, as well as other problems. Example 1

[0091] like Figures 1 to 11As shown, a closing system with a split support structure 2 according to an embodiment of the present application is illustrated, comprising a support recovery system 1, a first conveying system 4 and a second conveying system 5, wherein the support recovery system 1 comprises a split support structure 2 and a pulling assembly 3, the split support structure 2 comprises a support structure 21 and a capture member 22, which are detachably connected, and the first conveying system 4 and the second conveying system 5 are configured to convey a first connecting member 41 and a second connecting member 51 respectively through two pieces of tissue to be closed, and the distal end of the first connecting member 41 and the distal end of the second connecting member 51 are connected to the capture member 22.

[0092] In the first embodiment, the support structure 21 supports the tissue to be closed when the first conveying system 4 and the second conveying system 5 pass through the tissue to be closed.

[0093] In the first embodiment, after the first connecting member 41 and the second connecting member 51 are connected to the capture member 22, the support structure 21 is separated from the capture member 22, and the pulling assembly 3 pulls the support structure 21 back out of the body. Figure 8 shown.

[0094] In the first embodiment, the support and recovery system 1 includes a recovery outer sheath 11 , and the split support structure 2 and the pulling assembly 3 are pre-installed in the recovery outer sheath 11 .

[0095] In this embodiment, the pulling assembly 3 includes a channel adapter 31 and a pulling member 32. The support structure 21, the channel adapter 31, and the pulling member 32 are arranged in sequence from the distal end to the proximal end; the channel adapter 31 is connected to the center of the support structure 21, as shown in FIG. Figure 2 shown.

[0096] In the first embodiment, the channel adapter 31 is movably connected to the support structure 21. This design facilitates the adaptation of the channel adapter 31 to the foramen ovale channel and the fit of the support structure 21 to the left atrial surface, thus providing strong adaptability.

[0097] In the first embodiment, the capture member 22 includes a first unit 221 and a second unit 222. The first unit 221 is disc-shaped, and the second unit 222 is ring-shaped. The two are connected at the outer edge. Figure 12 and 13 and, the overlapping portion of the first unit 221 and the second unit 222 forms a placement space 223.

[0098] In the first embodiment, the placement space 223 is in a pouch shape.

[0099] In the first embodiment, the puncture points of the first puncture tube 42 and the second puncture tube 52 are set at the overlapping area 224 of the first unit 221 and the second unit 222. Figure 14 shown.

[0100] In the first embodiment, the overlapping area 224 is disc-shaped.

[0101] In the first embodiment, the support structure 21 includes a plurality of radially arranged support rods 211, such as Figure 15 and, the peripheral portion of the support structure 21 is pre-installed in the placement space 223.

[0102] In the first embodiment, the support rod 211 is made of nickel-titanium alloy; the support rod 211 is a metal rod or is woven from metal wires.

[0103] In the first embodiment, the first delivery system 4 includes a first puncture tube 42 , the second delivery system 5 includes a second puncture tube 52 , and the first connector 41 and the second connector 51 are pre-installed in the first puncture tube 42 and the second puncture tube 52 , respectively.

[0104] In the first embodiment, the first delivery system 4 includes a resting structure 43, a first loading tube 44 and a first puncture tube 42. The first puncture tube 42 is pre-installed in the first loading tube 44. Moreover, the distal end of the first loading tube 44 is movably connected to the resting structure 43. Figures 3 to 5 shown.

[0105] In the first embodiment, the first loading tube 44 has a bending function, and a plurality of slits are provided on the surface of the first loading tube 44 .

[0106] In the first embodiment, the abutment structure 43 includes an elastic member 431 and a push rod 433. The distal end of the first loading tube 44 is provided with a fitting member 441. The distal end of the elastic member 431 is provided with an opening 432. The fitting member 441 is connected to the opening 432. The connection between the two is as follows: a metal connecting wire 434 is provided at the opening 432. The fitting member 441 passes through the metal connecting wire 434. Thus, the fitting member 441 can move relative to the opening 432. The distal end of the first loading tube 44 can be rotated to be perpendicular to the elastic member 431. Figure 16 shown.

[0107] In this embodiment 1, the first connecting member 41 includes a first vertical member 411 and a first pull wire 412, and the second connecting member 51 includes a second vertical member 511 and a second pull wire 512; and the first vertical member 411 and the second vertical member 511 are connected to the distal surface of the capture member 22 after implantation.

[0108] In the first embodiment, the first vertical member 411 is parallel to the first puncture tube 42 when pre-installed on the first puncture tube 42 ; and the first vertical member 411 is parallel to or at a certain angle to the surface of the capture member 22 after being detached from the first puncture tube 42 .

[0109] In the first embodiment, the first vertical member 411 and the second vertical member 511 are made of polymer material or metal material; and the hardness of the first vertical member 411 and the second vertical member 511 is greater than that of the first pull wire 412 and the second pull wire 512 .

[0110] In the first embodiment, a proximal locking system 6 is further included. The proximal locking system 6 includes a locking structure 61 and a cutting structure 62 .

[0111] In this embodiment 1, the locking structure 61 is used to fix the first connecting member 41 and the second connecting member 51 located at the proximal surface of the tissue to be closed, and the cutting structure 62 shears the first connecting member 41 and the second connecting member 51 located at the proximal end of the locking structure 61.

[0112] In the first embodiment, the locking structure 61 is in the shape of a bolt head. Figure 11 shown.

[0113] In the first embodiment, the locking structure 61 enters the right atrium along the first pull wire 412 and the second pull wire 512 .

[0114] In the first embodiment, after the support structure 21 leaves the heart, pulling the first pulling member 412 and the second pulling member 512 can make the capture member 22 completely fit with the left atrial surface. Figure 9 As shown, the capture member 22 has good flexibility, which avoids the rigidity of the support structure 21 affecting the fit between the closing system and the left atrial surface, and when the proximal locking system 6 is tightened, the capture member 22 remains in a fitted state.

[0115] The exemplary operation process of the closed system of the first embodiment is as follows:

[0116] (1) Operate the support and retrieval system 1 through the femoral vein into the right atrium to the foramen ovale tissue, such as Figure 1 After the operation of the recovery sheath 11 releases the split support structure 2 in the left atrium, releases the traction assembly 3 in the foramen ovale channel and the right atrium, and then evacuates the recovery sheath 11, as Figure 2 As shown;

[0117] (2) Operate the first delivery system 4 and the second delivery system 5 to enter the right atrium, pull the pulling assembly 3 so that the support structure 21 and the split support structure 2 fit together with the left atrium surface, and then operate the push rod 433 to reach the target position, as shown in FIG. Figure 3 As shown;

[0118] (3) Push the first loading tube 44 so that the elastic member 431 is in close contact with the proximal surface of the secondary septum until the distal end of the first loading tube 44 is perpendicular to the elastic member 431. Figure 4 As shown, the first puncture tube 42 is pushed to puncture the secondary septum and the first vertical member 411 is pushed out. Figure 5 As shown;

[0119] (4) Push the second puncture tube 52 to puncture the secondary septal tissue and push out the second vertical member 511, as shown in FIG. Figure 6 As shown;

[0120] (5) Recover the first delivery system 4 and the second delivery system 5, and operate the recovery outer sheath 11 to enter the right atrium, such as Figure 7 Pull the pulling assembly 3 to recover the support structure 21, the capture member 22 remains in the left atrium, as Figure 8 As shown, and the first pull line 412 and the second pull line 512 are pulled, the capture member 22 is attached to the left atrial surface, and the secondary septal tissue and the primary septal tissue are closed, as shown. Figure 9 As shown;

[0121] (6) The proximal locking system 6 is operated to enter the right atrium along the first pull line 412 and the second pull line 512. The advancement of the locking structure 61 causes the secondary septal tissue and the primary septal tissue to approach each other until they are closed. When the locking structure 61 can no longer move distally, the tightening action is completed. Figure 11 As shown; operate the resection structure 62 to shear the first connecting member 41 portion and the second connecting member 51 portion located in the proximal direction of the locking structure 61, and evacuate the proximal locking system 6.

[0122] Example 2:

[0123] The difference from the first embodiment is that:

[0124] In the second embodiment, the separation method of the support structure 21 and the capture member 22 in the split support structure 2 is different, and the shape of the locking structure 61 is more conformable.

[0125] The following describes in detail the composition and connection of the various components in this embodiment with reference to the accompanying drawings:

[0126] In the second embodiment, a closing system with a split support structure 2 according to an embodiment of the present application is disclosed, including a support recovery system 1, a first conveying system 4 and a second conveying system 5, the support recovery system 1 includes a split support structure 2 and a pulling assembly 3, the split support structure 2 includes a support structure 21 and a capture member 22, and the two are detachably connected, the first conveying system 4 and the second conveying system 5 are configured to convey the first connecting member 41 and the second connecting member 51 respectively through two pieces of tissue to be closed, and the distal end of the first connecting member 41 and the distal end of the second connecting member 51 are connected to the capture member 22.

[0127] In the second embodiment, the pulling assembly 3 includes a channel adaptor 31 and an auxiliary clamping structure 33. Figure 17 As shown, the auxiliary clamping structure 33 is movably connected to the channel adapter 31; and the auxiliary clamping structure 33 and the support structure 21 respectively adhere to the proximal surface and the distal surface of the tissue to be closed.

[0128] In the second embodiment, the split support structure 2 includes a control member 23 and a connecting coil 24. Figure 18 As shown, the connecting coil 24 is arranged on the proximal surface of the capturing member 22 and the distal surface of the supporting structure 21, and the control member 23 passes through the connecting coil 24 arranged on the capturing member 22 and the supporting structure 21, and the supporting structure 21 and the capturing member 22 form a connection relationship.

[0129] In the second embodiment, the control member 23 is a metal wire; and the control member 23 is disposed inside the channel adaptor 31 .

[0130] In the second embodiment, the locking structure 61 is in the form of a sheet, and the locking structure 61 and the capture member 22 are made of the same elastic porous material. Figure 19 shown.

[0131] In the second embodiment, the locking structure 61 is attached to the right atrial surface of the foramen ovale, and the locking structure 61 and the heart tissue are endothelialized.

[0132] In the second embodiment, the locking structure 61 further includes a connecting piece 611 , and the connecting piece 611 is connected to the first pull wire 412 and the second pull wire 512 located at the proximal surface of the tissue to be closed.

[0133] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here. Example 3

[0134] The difference from the first embodiment is that:

[0135] In the third embodiment, the capturing member 22 is in a strip shape and is an elastic or shape memory film.

[0136] The following describes in detail the composition and connection of the various components in this embodiment with reference to the accompanying drawings:

[0137] In this embodiment three, a closing system with a split support structure 2 according to an embodiment of the present application is disclosed, including a support recovery system 1, a first conveying system 4 and a second conveying system 5, the support recovery system 1 includes a split support structure 2 and a pulling assembly 3, the split support structure 2 includes a support structure 21 and a capture member 22, the two are detachably connected, the first conveying system 4 and the second conveying system 5 are configured to convey the first connecting member 41 and the second connecting member 51 respectively through two pieces of tissue to be closed, and the distal end of the first connecting member 41 and the distal end of the second connecting member 51 are connected to the capture member 22.

[0138] In the third embodiment, the capture member 22 is an elastic membrane. When the support structure 21 and the capture member 22 are connected, the support structure 21 stretches the capture member 22. After the two are disassembled, the capture member 22 retracts and tightens, which plays a role of suturing and tightening to a certain extent. Figure 20 and 21 shown.

[0139] In the third embodiment, the capturing member 22 is in a strip shape, covering the secondary septal tissue and the primary septal tissue on the left atrial surface.

[0140] In this regard, the relevant structure and concept of the third embodiment are similar to those of the first embodiment, and thus will not be described again here. Example 4

[0141] The difference from the second embodiment is that:

[0142] In the fourth embodiment, the support structure 21 is at least partially provided on the distal end surface of the capture member 22 , and a retraction channel 25 is provided at the center of the capture member 22 .

[0143] The following describes in detail the composition and connection of the various components in this embodiment with reference to the accompanying drawings:

[0144] In this fourth embodiment, a closing system with a split support structure 2 according to an embodiment of the present application is disclosed, including a support recovery system 1, a first conveying system 4 and a second conveying system 5, the support recovery system 1 includes a split support structure 2 and a pulling assembly 3, the split support structure 2 includes a support structure 21 and a capture member 22, the two are detachably connected, the first conveying system 4 and the second conveying system 5 are configured to convey the first connecting member 41 and the second connecting member 51 respectively through two pieces of tissue to be closed, and the distal end of the first connecting member 41 and the distal end of the second connecting member 51 are connected to the capture member 22.

[0145] In the fourth embodiment, the split support structure 2 includes a control member 23 and a connecting coil 24. The control member 23 passes through the connecting coil 24 provided on the capture member 22 and the support structure 21. The support structure 21 and the capture member 22 form a detachable connection relationship. Figure 22 shown.

[0146] In the fourth embodiment, the support structure 21 is at least partially provided on the distal end surface of the capture member 22. Figure 23 and, a retraction channel 25 is provided at the center of the capture member 22 , and when the split support structure 2 is pre-installed, the support structure 21 and the control member 23 pass through the retraction channel 25 .

[0147] In the fourth embodiment, after the control member 23 is withdrawn from the withdrawal channel 25 , the support structure 21 is withdrawn from the withdrawal channel 25 ; and after both are withdrawn, the withdrawal channel 25 is automatically closed.

[0148] In the fourth embodiment, the connecting coil 24 is radially or circumferentially arranged on the surface of the capture member 22, such as Figure 24 and 25 shown.

[0149] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, configurations, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention and all equivalents thereof be defined by the appended claims.

Claims

1. A closure system with a split support structure, characterized in that: It includes a support and recovery system, a first conveying system and a second conveying system, the support and recovery system includes a split support structure and a pulling assembly, the split support structure includes a support structure and a capture member, the two are detachably connected, the first conveying system and the second conveying system are configured to convey the first connecting member and the second connecting member through two pieces of tissue to be closed respectively, and the distal end of the first connecting member and / or the distal end of the second connecting member are connected to the capture member, the capture member includes a first unit and a second unit, the first unit is disc-shaped, and the second unit is ring-shaped, and the two are connected at the peripheral edge; and the overlapping part of the first unit and the second unit forms a placement space; and the support structure includes a plurality of radially arranged support rods; and the peripheral part of the support structure is pre-installed in the placement space.

2. A closure system with a split support structure according to claim 1, characterized in that: The support structure supports the tissue to be closed when the first conveying system and the second conveying system pass through the tissue to be closed; and after the first connecting member and the second connecting member are connected to the capturing member, the support structure is separated from the capturing member, and the pulling assembly pulls the support structure back out of the body.

3. A closing system with a split support structure according to claim 1 or 2, characterized in that: The pulling assembly includes a channel adapter and an auxiliary clamping structure, wherein the auxiliary clamping structure is movably connected to the channel adapter; and the auxiliary clamping structure and the supporting structure respectively adhere to the proximal surface and the distal surface of the tissue to be closed.

4. A closing system with a split support structure according to claim 1 or 2, characterized in that: The first delivery system includes a first puncture tube, the second delivery system includes a second puncture tube, and the first connecting member and the second connecting member are pre-installed in the first puncture tube and the second puncture tube respectively.

5. The closure system with a split support structure according to claim 1, characterized in that: The split support structure includes a control part and a connecting coil, the control part passes through the connecting coil arranged on the capture part and the support structure, and the support structure and the capture part form a detachable connection relationship; and the connecting coil is radially or circumferentially arranged on the surface of the capture part.

6. The closure system with a split support structure according to claim 5, characterized in that: The support structure is at least partially arranged on the distal end surface of the capture member; and a withdrawal channel is provided at the center of the capture member, and when the split support structure is pre-installed, the support structure and the control member pass through the withdrawal channel.

7. The closure system with a split support structure according to claim 1, characterized in that: The first connecting member includes a first vertical member and a first pull wire, and the second connecting member includes a second vertical member and a second pull wire; and the first vertical member and the second vertical member are connected to the distal end surface of the capture member after implantation.

8. The closure system with a split support structure according to claim 1, characterized in that: It also includes a proximal locking system, which includes a locking structure and a cutting structure; the locking structure is used to fix the first connector and the second connector located on the proximal surface of the tissue to be closed, and the cutting structure shears the first connector part and the second connector part located at the proximal end of the locking structure; and the locking structure is in the shape of a bolt head; or, the locking structure is in the shape of a sheet, and the locking structure and the capturing member are made of the same elastic porous material.

9. The closure system with a split support structure according to claim 1, characterized in that: The capturing member is a laminating film or a felt sheet, and is strip-shaped; and the capturing member includes reinforcing ribs.

10. The closure system with a split support structure according to claim 1, characterized in that: The capture member is an elastic or shape memory membrane; and when the support structure and the capture member are connected, the support structure stretches out the capture member, and after the two are disassembled, the capture member retracts and tightens.

11. A closure system with a support structure, characterized in that: The invention comprises a support recovery system, a first conveying system and a second conveying system, wherein the support recovery system comprises a support structure and a pulling assembly, wherein the support structure and the pulling assembly are detachably connected, the support structure comprises a reinforcing frame and a capturing member, and the first conveying system and the second conveying system are configured to convey a first connecting member and a second connecting member respectively through two pieces of tissue to be closed, and the distal end of the first connecting member and / or the distal end of the second connecting member are connected to the capturing member; Furthermore, the support structure supports the tissue to be closed when the first conveying system and the second conveying system pass through the tissue to be closed; the capturing member includes a first unit and a second unit, the first unit is disc-shaped, and the second unit is ring-shaped, and the two are connected at the peripheral edge; and the overlapping part of the first unit and the second unit forms a placement space; and the support structure includes a plurality of radially arranged support rods; and the peripheral part of the support structure is pre-installed in the placement space.

12. The closure system according to claim 11, characterized in that: The reinforcing skeleton is a polymer or a degradable metal material.

Images