Closing system with split type supporting structure
By designing a closure system with split support structure, the split support structure and capture parts are used to achieve tissue closure, which solves the problem of metal implants affecting fit and operation difficulties, and improves the closure effect and safety.
Patent Information
- Application Number
- CN202310937187.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-07-28
- Publication Date
- 2025-02-14
- Estimated Expiration
- 2043-07-28
AI Technical Summary
In the prior art, metal implants affect the bonding of the flow blocking membrane and tissue, and the operation of piercing or suturing the secondary septum and primary septum tissues is difficult, and it is impossible to ensure whether the peripheral part is leaking by fixing the center of the disk, resulting in Poor closure and high risk of blood leakage.
A closed system with a split support structure is designed, through the support recovery system, the first conveying system and the second conveying system, the split support structure and the capture member are used to achieve the closure of the tissue. The support structure is evacuated after completing the support function. In vivo, only the capture piece is retained to fit the tissue, reducing the impact of the metal implant.
It improves the fitting effect and safety of tissue closure, reduces the use of metal implants, reduces the risk of blood leakage, simplifies the difficulty of operation, and improves the success rate of surgery.
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Figure CN119423858A_ABST
Abstract
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 passage of the atrial septum during the embryonic period. The fetus has no pulmonary circulation, and the oxygenated blood from the umbilical cord flows from the right atrium of the fetus through the foramen ovale into the left atrium. After birth, with the establishment of pulmonary circulation, the pressure in the left atrium increases, the secondary septum and the primary septum approach each other, adhere and fuse, and gradually form a permanent atrial septum. However, there are still some people who have not fused, forming a patent foramen ovale (PFO for short). The traditional treatment for patent foramen ovale is surgery. For surgical treatment, patients need to undergo a surgical thoracotomy. The main disadvantages of surgery are: extracorporeal circulation is required during the operation, and the operation may cause complications and lead to death; the surgical operation is traumatic and leaves scars after the operation; the cost of surgery is expensive. With the development and improvement of interventional treatment technology, the method of treating PFO through minimally invasive interventional technology is now very mature. Minimally invasive interventional treatment has the advantages of no surgery, less trauma, fewer complications, faster recovery, better results, a wide range of indications and relatively low surgical costs, but there are more or less problems in use.
[0003] Patent CN202210863123.2 discloses a device for closing tissue, which completes the closure of the oval foramen tissue by connecting the first support body and the second support body with sutures. 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. In addition, since the support rod and the baffle membrane are wrapped with each other, the support rod is a metal implant, which easily leaves a gap between the baffle 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, and 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 located 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 prior art has the following problems that need to be solved urgently: first, the problem that metal implants affect the adhesion between the flow-blocking membrane and the tissue; second, the difficulty in puncturing or suturing the secondary septal tissue and the primary septal tissue back and forth; third, the problem that by fixing the center of the occluding disk, it is impossible to ensure whether the peripheral part leaks 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 provide a closed system with a split support structure in view of the unreasonable design of metal implants and flow-blocking membrane coverings.
[0007] The object of the present invention is achieved through the following solutions: A closing system with a split support structure comprises a support recovery system, a first conveying system and a second conveying 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 capture member, and the two are detachably connected, 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 capture member.
[0008] The purpose of the present invention can be further achieved by the following technical solutions: Furthermore, after the first connecting member and the second connecting member are connected to the capturing member, the supporting structure is separated from the capturing member, and the pulling assembly pulls the supporting structure back out of the body.
[0009] Furthermore, 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. Furthermore, the capture member and the distal ends of the first connecting member and the second connecting member are located at the distal surface of the tissue to be closed after implantation.
[0010] Furthermore, the capturing member fits the distal surface of the tissue to be closed.
[0011] Furthermore, the capture member, the distal end or distal portion of the first connecting member, and the distal end or distal portion of the second connecting member form a closed loop at the distal surface of the tissue to be closed.
[0012] Further, the first delivery system is capable of delivering a plurality of the first connectors through secondary septal tissue.
[0013] Furthermore, the second delivery system is capable of delivering a plurality of the second connecting members through the foramen ovale tissue.
[0014] Furthermore, the support recovery system includes a recovery outer sheath tube, and the split support structure and the pulling assembly are pre-installed in the recovery outer sheath tube.
[0015] Furthermore, 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 fit the proximal surface and the distal surface of the tissue to be closed.
[0016] Further, the channel adapter is connected to the center of the support structure.
[0017] Furthermore, the channel adapter is movably connected to the supporting structure.
[0018] Furthermore, the capture member includes a first unit and a second unit, the first unit is in a disc shape, the second unit is in a ring shape, 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.
[0019] Furthermore, the placement space is in a pouch shape.
[0020] Furthermore, the support structure includes a plurality of radially arranged support rods; and the peripheral portion of the support structure is pre-installed in the placement space.
[0021] Furthermore, the support rod is made of nickel-titanium alloy material.
[0022] Furthermore, 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.
[0023] Furthermore, 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.
[0024] Furthermore, the overlapping area is disc-shaped.
[0025] Furthermore, the split support structure includes a control member and a connecting coil, the connecting coil is arranged on the proximal surface of the capture member and the distal surface of the support structure, the control member passes through the connecting coil arranged on the capture member and the support structure, and the support structure and the capture member form a connection relationship.
[0026] Furthermore, the connecting coil is radially arranged or circumferentially arranged on the surface of the capturing member.
[0027] Furthermore, 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.
[0028] Further, after the control member is evacuated from the withdrawal channel, the support structure is evacuated from the withdrawal channel; and after both are evacuated, the withdrawal channel is automatically closed.
[0029] Furthermore, the control member is a metal wire.
[0030] Furthermore, the control member is arranged inside the channel adapter.
[0031] Further, 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.
[0032] Further, 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.
[0033] Furthermore, the first vertical member and the second vertical member are made of polymer material or metal material; and the hardness of the second vertical member of the first vertical member is greater than that of the first pull wire and the second pull wire.
[0034] Furthermore, it also includes a proximal locking system, which includes a locking structure and a cutting structure.
[0035] 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.
[0036] Further, the cutting structure shears the first connecting member portion and the second connecting member portion located at the proximal end of the locking structure.
[0037] Furthermore, the locking structure is in the shape of a bolt head.
[0038] 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.
[0039] Furthermore, the locking structure is disc-shaped and is made of a film material.
[0040] Furthermore, the locking structure is attached to the right atrial surface of the foramen ovale, and the locking structure and the heart tissue undergo endothelialization.
[0041] Furthermore, the locking structure further comprises a connecting piece, and the connecting piece is connected to the first pull wire and the second pull wire located at the proximal surface of the tissue to be closed.
[0042] Furthermore, the capturing member is a bonding film or a felt sheet.
[0043] Furthermore, the capturing member is in a strip shape.
[0044] Furthermore, the capture member includes reinforcing ribs, which play a shaping role in forming the unfolding disk surface.
[0045] Furthermore, the capturing element is an elastic or shape memory film.
[0046] Furthermore, 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, which plays a role of suturing and tightening to a certain extent.
[0047] 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.
[0048] Further, an upper region of the support structure is arranged on a proximal surface of the capture member, and a lower region is arranged on a distal surface of the capture member.
[0049] Furthermore, the reinforcing ribs are made of polymer material.
[0050] Furthermore, the reinforcing rib is made of nickel-titanium alloy material.
[0051] Further, the locking structure enters the right atrium along the first pull wire and the second pull wire.
[0052] Furthermore, the support recovery system enters the right atrium to the foramen ovale tissue through the femoral vein, and 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.
[0053] 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.
[0054] Furthermore, the distal end of the first loading tube is movably connected to the abutment structure.
[0055] Furthermore, the first delivery system and the second delivery system are operated to enter the right atrium, and the pulling assembly is pulled to make the support structure and the split support structure fit the left atrial surface, and then the push rod is operated to reach the target position, and the first loading tube is pushed so that the elastic part is close to 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.
[0056] Furthermore, the second puncture tube is pushed to puncture the secondary septal tissue.
[0057] Further, the first delivery system and the second delivery system are recovered; and the recovery outer sheath is operated to enter the right atrium, and the pulling component is pulled to recover the support structure.
[0058] Furthermore, 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 makes the two pieces of tissue to be closed fit together until the locking structure can no longer move distally, and the tightening action is completed.
[0059] Furthermore, the capture member is elastic, and the capture member is expanded when the support structure is arranged in the placement space.
[0060] Furthermore, the treatable indications of the capture element include patent foramen ovale problems and atrial septal defect problems.
[0061] Compared with the prior art, the advantages of the technical solution of the present application include at least the following: 1. In the prior art, in order to achieve the closure of the foramen ovale tissue, it is often necessary to use metal parts to achieve occlusion or support, but the implantation of metal parts will affect the fitting effect and produce adverse reactions, and the existing suturing devices usually need to be pierced back and forth multiple times, or need to pierce 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 solution of the present application solves the above problems. First, the present application designs a split support structure, which provides support for tissue puncture, abuts against the other side of the first delivery system and the second delivery system, and at the same time, in order to reduce The influence of metal implants, the support structure of the split support structure is withdrawn from the body after completing its supporting function, and only the capture piece is retained 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, thus avoiding adverse reactions caused by metal ions and promoting the process of endothelialization. On the other hand, since the first delivery system and the second delivery system pass through the two tissues to be closed respectively, namely the secondary septum tissue and the primary septum tissue respectively, there is no need for a tube or component 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.
[0062] 2. Different from the existing technology, after the implantation is completed, only the capture piece and the connecting piece are retained at the lesion. Compared with the simple suturing method, the capture piece covers a larger left atrial surface and has a better closure effect. Compared with the double-disc structure, the metal implant is extremely low, which is convenient for the patient to recover. Moreover, since the capture piece is made of flexible material, it has good compliance. On the other hand, if the patient has other heart lesions, such as mitral regurgitation, the surgeon can still puncture through the atrial septum tissue without affecting the secondary intervention.
[0063] 3. Different from the prior art, the capture piece is arranged on the left atrial surface, and the action point or fixing point of the capture piece depends on the puncture position. The puncture position is controlled by the operator. The operator can select the puncture position according to the shape of the patient's foramen ovale, and can also decide the number of first connecting pieces and second connecting pieces to be delivered according to the surgical situation. The puncture point of the present application is generally selected at the center of the secondary septal tissue and the primary septal tissue, and is fixed at at least two or three points, so that the capture piece can maintain 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, and does not excessively correct the original morphology of the tissue, and is more humane.
[0064] 4. Different from the prior art, the support structure includes radially arranged support rods. The advantage of such arrangement is that it does not occupy excessive space and does not interfere with the first puncture tube or the second puncture tube. Moreover, when the first connecting member or the second connecting member forms a connection relationship with the capture member, the support structure will not interfere with the first connecting member or the second connecting member when it is recovered. 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.
[0065] 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 performs puncture, it can cooperate with the support structure to better rest against the distal surface of the secondary septal tissue, and when the second puncture tube performs puncture, 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 recovered support structure, and will not expand the size of the recovered outer sheath.
[0066] 6. Different from the prior art, the capture member of the present application is an elastic membrane, which is in a stretched state when connected to the supporting 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.
[0067] 7. Different from the prior art, 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 oval foramen tissue on the left atrial surface, ensuring the puncture effect. When the capture piece is in contact, puncture can ensure that the puncture point on the capture piece is not enlarged, and the puncture tube can be withdrawn very smoothly, which is convenient for improving the success rate of the operation.
[0068] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one, and these other technical effects may be partially described below; and are predictable and understandable to those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS
[0069] 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 by referring to the following description together with the accompanying drawings; and the embodiments of the present application can be better understood, in which: Figures 1 to 11 It is a schematic diagram and principle diagram of the operation process of the closed system in the first embodiment of the present invention.
[0070] Figures 12-14 A schematic diagram of the structure of the capture element in the first embodiment of the present invention Fig.15 It is a structural schematic diagram of the support structure in the first embodiment of the present invention.
[0071] Fig.16 It is a schematic diagram of the principle of the first loading tube rotating relative to the abutting structure in the first embodiment of the present invention.
[0072] Fig.17 It is a schematic diagram of a pulling assembly including an auxiliary clamping structure in Embodiment 2 of the present invention.
[0073] Fig.18 Another embodiment of the present invention is to separate the supporting structure and the capturing member.
[0074] Fig.19 This is another embodiment of the locking structure of the present invention.
[0075] Fig. 20 and 21 This is an embodiment of the present invention in which the capture member is an elastic film.
[0076] Figures 22 to 25 This is another embodiment of the split support structure of the present invention.
[0077] The features indicated by the numbers in the accompanying drawings are as follows: 1-support recovery system, 11-recovery outer sheath, 2-split support structure, 21-support structure, 211-support rod, 22-capture member, 221-first unit, 222-second unit, 223-placement space, 224-overlapping area, 23-control member, 24-connection coil, 25-retreat channel, 3-traction assembly, 31-channel adapter, 32-pulling member, 33-auxiliary clamping structure, 4-first delivery system, 41-first connecting member, 41 1-first vertical member, 412-first pull wire, 42-first puncture tube, 43-resting structure, 431-elastic member, 432-opening, 433-top rod, 434-metal connecting wire, 44-first loading tube, 441-matching member, 5-second conveying system, 51-second connecting member, 511-second vertical member, 512-second pull wire, 52-second puncture tube, 6-proximal locking system, 61-locking structure, 611-connecting member, 62-resection structure. DETAILED DESCRIPTION
[0078] In the following description of the drawings and specific embodiments, the details of one or more embodiments of the present application will be described. From these descriptions, drawings and claims, other features, purposes and advantages of the present application can be clearly seen.
[0079] It should be understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include", "comprises", or "having" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents and additional items.
[0080] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.
[0081] In the present application, the term “proximal end” or “proximal side” refers to an end or a side closer to a surgical operator, and the term “distal end” or “distal side” refers to an end or a side farther from a surgical operator.
[0082] In the prior art, there are problems of poor closure effect due to the support structure and the capture member being connected and remaining together in the heart, and a problem of metal particles affecting the patient.
[0083] One of the purposes of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems. Embodiment 1
[0084] 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, wherein the split support structure 2 comprises a support structure 21 and a capture member 22, which are detachably connected, and wherein 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 wherein 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.
[0085] 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.
[0086] In the first embodiment, after the first connecting member 41 and the second connecting member 51 are connected to the capturing member 22, the supporting structure 21 is separated from the capturing member 22, and the pulling assembly 3 pulls the supporting structure 21 back out of the body. Figure 8 shown.
[0087] In the first embodiment, the support recovery system 1 includes a recovery outer sheath tube 11 , and the split support structure 2 and the pulling assembly 3 are pre-installed in the recovery outer sheath tube 11 .
[0088] In the first embodiment, the pulling assembly 3 includes a channel adaptor 31 and a pulling member 32. The support structure 21, the channel adaptor 31, and the pulling member 32 are arranged from the distal end to the proximal end in sequence; the channel adaptor 31 is connected to the center of the support structure 21, such as Figure 2 shown.
[0089] In the first embodiment, the channel adapter 31 is movably connected to the support structure 21. This design facilitates the channel adapter 31 to adapt to the foramen ovale channel and the support structure 21 to fit the left atrial surface, and has strong adaptability.
[0090] In the first embodiment, the capture member 22 includes a first unit 221 and a second unit 222. The first unit 221 is in the shape of a disk, and the second unit 222 is in the shape of a ring. The two are connected at the outer edges. Fig.12 and 13 As shown; and, the overlapping portion of the first unit 221 and the second unit 222 forms a placement space 223.
[0091] In the first embodiment, the placement space 223 is in a bag shape.
[0092] In the first embodiment, the puncture points of the first puncture tube 42 and the second puncture tube 52 are set in the overlapping area 224 of the first unit 221 and the second unit 222. Fig.14 shown.
[0093] In the first embodiment, the overlapping area 224 is in a disc shape.
[0094] In the first embodiment, the support structure 21 includes a plurality of radially arranged support rods 211, such as Fig.15 As shown; and, the peripheral portion of the support structure 21 is pre-installed in the placement space 223.
[0095] In the first embodiment, the support rod 211 is made of nickel-titanium alloy material; the support rod 211 is a metal rod or is woven from metal wires.
[0096] 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 connecting member 41 and the second connecting member 51 are pre-installed in the first puncture tube 42 and the second puncture tube 52 , respectively.
[0097] In the first embodiment, the first delivery system 4 includes a support structure 43, a first loading tube 44 and a first puncture tube 42, wherein the first puncture tube 42 is pre-installed in the first loading tube 44; and the distal end of the first loading tube 44 is movably connected to the support structure 43, such as Figure 3 to Figure 5 shown.
[0098] 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 .
[0099] In the first embodiment, the abutment structure 43 includes an elastic member 431 and a push rod 433, and a matching member 441 is provided at the distal end of the first loading tube 44; and an opening 432 is provided at the distal end of the elastic member 431, and the matching member 441 is connected to the opening 432, and the connection between the two is: by providing a metal connecting wire 434 at the opening 432, the matching member 441 passes through the metal connecting wire 434, so that the matching member 441 can move relative to the opening 432, and the distal end of the first loading tube 44 can be rotated to be perpendicular to the elastic member 431, such as Fig.16 shown.
[0100] In the first embodiment, 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.
[0101] 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 separated from the first puncture tube 42 .
[0102] 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 .
[0103] 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 .
[0104] In the first embodiment, 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.
[0105] In the first embodiment, the locking structure 61 is in the shape of a bolt head. Fig.11 shown.
[0106] In the first embodiment, the locking structure 61 enters the right atrium along the first pull wire 412 and the second pull wire 512 .
[0107] 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 atrium surface. Fig. 9 As shown, the capture member 22 has good flexibility, which prevents the rigidity of the support structure 21 from 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 maintains a fit state.
[0108] The exemplary operation process of the closed system of the first embodiment is as follows: (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 As shown; after the operation of the recovery outer sheath 11 releases the split support structure 2 in the left atrium, releases the traction assembly 3 in the oval foramen channel and the right atrium, and then withdraws the recovery outer sheath 11, as Figure 2 As shown; (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 are in contact 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; (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 push out the first vertical member 411, as shown in FIG. Figure 5 As shown; (4) Pushing the second puncture tube 52 to puncture the secondary septal tissue and push out the second vertical member 511, such as Figure 6 As shown; (5) Recovering the first delivery system 4 and the second delivery system 5, and operating 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, 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 in FIG. Fig. 9 As shown; (6) The proximal locking system 6 is operated to enter the right atrium along the first pull wire 412 and the second pull wire 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. Fig.11 As shown; operate the resection structure 62 to shear the first connecting member 41 and the second connecting member 51 located in the proximal direction of the locking structure 61, and evacuate the proximal locking system 6.
[0109] Embodiment 2: The difference from the first embodiment is that: 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 fit.
[0110] The composition and connection mode of each component in this embodiment will be described in detail below with reference to the accompanying drawings: 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, the two are detachably connected, 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.
[0111] In the second embodiment, the pulling assembly 3 includes a channel adaptor 31 and an auxiliary clamping structure 33. Fig.17 As shown, the auxiliary clamping structure 33 is movably connected to the channel adaptor 31; and the auxiliary clamping structure 33 and the supporting structure 21 are respectively in contact with the proximal surface and the distal surface of the tissue to be closed.
[0112] In the second embodiment, the split support structure 2 includes a control member 23 and a connecting coil 24. Fig.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, so that the supporting structure 21 and the capturing member 22 form a connection relationship.
[0113] In the second embodiment, the control member 23 is a metal wire; and the control member 23 is disposed inside the channel adaptor 31 .
[0114] 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. Fig.19 shown.
[0115] 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 undergo endothelialization.
[0116] 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.
[0117] 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. Embodiment 3
[0118] The difference from the first embodiment is that: In the third embodiment, the capture member 22 is in a strip shape, and the capture member 22 is an elastic or shape memory film.
[0119] The composition and connection mode of each component in this embodiment will be described in detail below with reference to the accompanying drawings: In the third 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 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.
[0120] 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. Fig. 20 and 21 shown.
[0121] In the third embodiment, the capture member 22 is in a strip shape, covering the secondary septal tissue and the primary septal tissue on the left atrial surface.
[0122] 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. Embodiment 4
[0123] The difference from the second embodiment is that: In the fourth embodiment, the support structure 21 is at least partially disposed on the distal end surface of the capture member 22 , and a withdrawal channel 25 is provided at the center of the capture member 22 .
[0124] The composition and connection mode of each component in this embodiment will be described in detail below with reference to the accompanying drawings: In the 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 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.
[0125] In the fourth embodiment, the split support structure 2 includes a control member 23 and a connection coil 24. The control member 23 passes through the connection 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. Fig. 22 shown.
[0126] In the fourth embodiment, the support structure 21 is at least partially disposed on the distal end surface of the capture member 22. Fig.23 As shown; and, a withdrawal 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 withdrawal channel 25.
[0127] 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.
[0128] In the fourth embodiment, the connecting coil 24 is radially or circumferentially arranged on the surface of the capture member 22, such as Fig.24 and 25 shown.
[0129] The foregoing description of several embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.
Claims
1. A closed system with a split support structure, characterized in that: It includes a support recovery system, a first conveying system and a second conveying system, the support 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 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 capture member.
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 adaptor and an auxiliary clamping structure, wherein the auxiliary clamping structure is movably connected to the channel adaptor; and the auxiliary clamping structure and the supporting structure respectively fit 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. A closure system with a split support structure according to claim 1, characterized in that: The split support structure includes a control member and a connecting coil, wherein the control member passes through the connecting coil arranged on the capture member and the support structure, and the support structure and the capture member form a detachable connection relationship; and the connecting coil is radially or circumferentially arranged on the surface of the capture member.
6. A 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. A closing system with a split support structure according to claim 1 or 2, characterized in that: The capture member includes 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; and the support structure includes a plurality of radially arranged support rods; and the outer peripheral part of the support structure is pre-installed in the placement space.
8. A 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.
9. A closing system with a split support structure according to claim 7, 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.
10. A closure system with a split support structure according to claim 1, characterized in that: The capturing member is a bonding film or a felt sheet, and is in a strip shape; and the capturing member includes reinforcing ribs.
11. A closure system with a split support structure according to claim 1, characterized in that: The capture member is an elastic or shape memory film; 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.
12. A closure system with a support structure, characterized in that: It 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, wherein the support structure comprises a reinforcing frame and a capturing member, wherein 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 tissues to be closed, and wherein 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 delivery system and the second delivery system pass through the tissue to be closed.
13. The closure system according to claim 12, characterized in that: The reinforcing skeleton is a polymer or a degradable metal material.
Citation Information
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