A tissue puncture closure device with a control mechanism

Abstract

This application relates to the field of medical devices, and more particularly to a tissue puncture closure device with a control device, including a delivery system and an implant for closing tissue defects. The control device includes a connection control mechanism and a guide control mechanism. The implant includes a blocking member and a connector connected to the blocking member. The delivery system includes a puncture member and a pusher member for pushing the blocking member. The connection control mechanism includes a first connecting structure disposed on the blocking member and a second connecting structure disposed on the pusher member and detachably connected to the first connecting structure. The blocking member and the pusher member are slidably sleeved within the puncture member. The guide control mechanism includes a first guide structure disposed on the distal portion of the puncture member and a second guide structure disposed on the blocking member and / or the pusher member. The connection control mechanism and the guide control mechanism respectively restrict the axial movement and circumferential rotation of the blocking member relative to the puncture member, ensuring that the blocking member does not prematurely detach from the puncture member or rotate arbitrarily.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a tissue puncture closure device containing a control device. Background Technology

[0002] The foramen ovale is a physiological passage in the atrial septum of the heart during embryonic development. Since the fetus lacks pulmonary circulation, oxygenated blood from the umbilical cord flows from the right atrium into the left atrium through the foramen ovale. After birth, as pulmonary circulation develops, the pressure in the left atrium increases, causing the secondary and primary septa to approach and fuse, gradually forming a permanent atrial septum. However, in some individuals, this fusion fails, resulting in patent foramen ovale (PFO). The traditional treatment for PFO is surgery. This surgical approach requires open-chest surgery. The main disadvantages of surgery are: the need for cardiopulmonary bypass, the potential for complications leading to death, significant surgical trauma, postoperative scarring, and high cost. With the development and improvement of interventional techniques, minimally invasive interventional treatment for PFO is now very mature. Minimally invasive interventional treatment has advantages such as no incision, minimal trauma, fewer complications, faster recovery, better efficacy, wider range of indications, and relatively lower cost. However, each method has its own set of problems.

[0003] Patent CN202111079739.2 discloses a closure device for tissue defects. The closure device includes a locking unit and a release unit located in the proximal region of the locking unit. The locking unit includes at least one or more locking elements. By operating the release unit, the locking elements are rotated, and the locking elements move closer to each other and achieve self-locking, thereby closing the tissue defect. The design flaws of this solution are as follows: First, the fixation element is pushed out by the ejector pin, which can only provide pushing force to the fixation element and cannot provide pulling force. Therefore, there is a problem that the fixation element may detach from the ejector pin before the puncture needle is inserted, causing premature release of the fixation element and failure of the operation. Second, the fixation element is not restricted by any component inside the puncture needle. During the operation, the axial movement of the fixation element may be accompanied by rotation, which may cause the locking unit to rotate or move in other directions, resulting in the locking unit being cut by the side groove on the puncture needle or interference.

[0004] In summary, the existing technology has the following problems that urgently need to be solved: First, the problem of implantation failure caused by the uncontrolled premature disengagement of the blocking component; Second, the problem that the connecting component is prone to interference with the puncture component or even makes disengagement difficult due to the rotation of the blocking component during movement. Summary of the Invention

[0005] This application is made in view of the above and other ideas.

[0006] One of the purposes of this application is to overcome the shortcomings of the prior art and provide a tissue puncture closure device with a control device, addressing the unreasonable structure of the control device for releasing the blocking element.

[0007] The objective of this invention is achieved through the following solution:

[0008] A tissue puncture closure device with a control mechanism includes a delivery system and an implant for closing tissue defects. The control mechanism includes a connection control mechanism and a guide control mechanism. The implant includes a blocking member and a connector connected to the blocking member. The delivery system includes a puncture member and a pusher member for pushing the blocking member. The connection control mechanism includes a first connection structure disposed on the blocking member and a second connection structure disposed on the pusher member and detachably connected to the first connection structure. The blocking member and the pusher member are slidably fitted within the puncture member. The guide control mechanism includes a first guide structure disposed on the distal portion of the puncture member and a second guide structure disposed on the blocking member and / or the pusher member. The connection control mechanism and the guide control mechanism respectively restrict the axial movement and circumferential rotation of the blocking member relative to the puncture member.

[0009] The objective of this invention can also be further achieved through the following technical solutions:

[0010] Furthermore, the first guide structure is a strip-shaped side groove provided on the puncture member, and the second guide structure is a protrusion or slider provided on the blocking member or pushing member; and the first guide structure provides an axial sliding track for the second guide structure.

[0011] Furthermore, the second guide structure is a slider disposed on the pusher, and the slider and the side groove are in clearance fit.

[0012] Furthermore, the second guide structure is shaped like a car front in the axial section, and the outer surface of the second guide structure is smooth.

[0013] Furthermore, on the axial section of the nearest end of the first guide structure, the section of the second guide structure coincides with the section of the first guide structure, and the second guide structure does not extend beyond the outer circumferential surface of the puncture member in the circumferential direction.

[0014] Furthermore, the conveying system includes a first reference plane and a second reference plane that are perpendicular to each other; and the centerline of the first guide structure and the generatrix of the sharpest point of the puncture member are both on the first reference plane.

[0015] Furthermore, the puncture member also includes a guide rail, and the blocking member also includes a boss disposed on the side, the boss being connected to the guide rail; and the centerline of the guide rail is on the second reference plane.

[0016] Furthermore, the puncture member includes two guide rails, and the blocking member includes two symmetrical bosses.

[0017] Furthermore, the blocking member is positioned within the puncture member along the guide rail, ensuring that the blocking member will not rotate within the puncture member.

[0018] Furthermore, the blocking member includes two connecting holes, and the connecting member passes through the two connecting holes in sequence and is knotted; and, during the process of the pusher pushing or pulling the blocking member, the connecting member moves along the first guide structure.

[0019] Furthermore, the first connecting structure includes a first protrusion and a first groove, and the second connecting structure includes a second protrusion and a second groove; and when the first connecting structure is connected to the second connecting structure, the first protrusion is at least partially fitted with the second groove, and the second protrusion is at least partially fitted with the first groove.

[0020] Furthermore, the surface of the first protrusion is smooth and without sharp corners.

[0021] Furthermore, the first protrusion is crescent-shaped.

[0022] Furthermore, the first groove and the second protrusion interact with each other, and the first connecting structure and the second connecting structure mutually restrict each other. The control device does not rotate, and the blocking member cannot rotate, thus preventing the phase change of the blocking plate.

[0023] Furthermore, the first connecting structure includes a mating part and a connecting part, and the second connecting structure includes a mating groove and a connecting channel; and when the first connecting structure and the second connecting structure are connected, the mating part is at least partially fitted with the mating groove, and the connecting part is at least partially sleeved in the connecting channel.

[0024] Furthermore, the mating part and the connecting part are combined in a hammer shape.

[0025] Furthermore, the connecting channel includes a supporting surface that fits against the connecting portion. The supporting surface acts on the connecting portion to prevent the connecting portion from rotating, thus ensuring that the blocking member does not rotate.

[0026] Furthermore, the length of the blocking member is greater than the width of the blocking member, and the width of the blocking member is greater than the height of the blocking member; and the width-to-height ratio of the blocking member is 1.2 to 3.

[0027] Preferably, the width-to-height ratio of the blocking member is 1.5 to 2.

[0028] Furthermore, the length of the blocking member is 5-20mm, the width is 0.3-2mm, and the height is 0.1-0.3mm.

[0029] Furthermore, the height of the blocking member is greater than the width of the side groove.

[0030] Furthermore, the implant includes two blocking elements, and the delivery system includes one or two puncture elements; and the puncture elements deliver the two blocking elements through the secundum and primordial septum, respectively.

[0031] Furthermore, the implant also includes a closure sleeve, and the delivery system further includes a fixation member and a pushing structure; and the fixation member is connected to the connector, and the pushing structure is used to push the closure sleeve toward the distal end.

[0032] Furthermore, during pre-assembly, the closing sleeve is fitted over the connector or the fixing member.

[0033] Furthermore, the implant includes a connector, the two ends of which are respectively connected to the two blocking members; or, the implant includes two connectors, the two ends of which are respectively connected to the blocking member and the fixing member.

[0034] Furthermore, the blocking member has a connecting hole inside, and the connecting hole is connected to the distal end of the connecting member.

[0035] Furthermore, the distal end of the puncture member is pointed.

[0036] Furthermore, the centerline of the connecting hole is on the center surface of the side groove, meaning the connecting hole is visible through the side groove surface.

[0037] Furthermore, after the blocking member is released at the target position, the closing sleeve is moved toward the distal end. The smaller the distance between the distal end of the connector and the closing sleeve, the closer the two blocking members are, and the closer the secondary and primary partitions are.

[0038] Furthermore, the barrier is inserted into the left atrium along with the puncture device.

[0039] Furthermore, the pushing structure includes a separating structure that, when the closed sleeve is close to the interatrial septum and no further movement towards the proximal end is required, operates the separating structure to cut off the connector located at the proximal end of the closed sleeve.

[0040] Furthermore, the connector is linear and is made of polymer or metal.

[0041] Furthermore, the outer surface of the blocking member is at least partially tangent to the inner surface of the puncturing member.

[0042] Furthermore, the outer surface of the second connecting structure is at least partially tangent to the inner surface of the puncture member.

[0043] Furthermore, the blocking element is flat.

[0044] Furthermore, the distal end of the blocking member is similar to a probe, and it first punctures the fossa tissue, after which the puncture member passes through the tissue.

[0045] Furthermore, the blocking element is cylindrical.

[0046] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0047] 1. In the prior art, the control device is only used to push the blocking component and does not provide tension to the blocking component. The blocking component is not restricted, and during the operation, it is easy for the blocking component to detach prematurely from the puncture component, leading to problems such as failure to fix the blocking component or inaccurate control of its position. Furthermore, the blocking component is prone to rotation under the push of the control device, which can cause interference between the connecting component and the puncture component, or even make it difficult to detach. The technical solution of this application avoids the above problems. This solution uses a tissue puncture closure instrument with a control device, including a delivery system and an implant for closing tissue defects. The control device includes a connecting control mechanism. The blocking component and the pushing component each include a first connecting structure and a second connecting structure. The cooperation between the two prevents the first connecting structure from moving relative to the second connecting structure; that is, when the second connecting structure is fixed, the first connecting structure will not move. The axial movement or rotation of the device ensures that the blocking element will not arbitrarily detach from the control device. The blocking element only separates from the control device when it pushes the blocking element away from the puncture piece. On the other hand, since the closure instrument enters the right atrium via the femoral vein approach using a combination of long and curved approaches, the blocking element cannot be prevented from rotating when the control device is pushed distally. Therefore, the control device also includes a guiding control mechanism. The guiding control mechanism includes a first guiding structure located at the distal end of the puncture piece and a second guiding structure located on the blocking element and / or the pushing element. The first guiding structure provides an axial sliding track for the second guiding structure, ensuring that the control device will not rotate during axial movement. It also avoids operator misoperation of the control device, thus effectively preventing the blocking element from rotating when pushed. This ensures that the blocking element is completely controlled, improves the success rate of the operation, and has significant clinical implications.

[0048] 2. According to a concept of this application, the delivery system includes a first reference plane and a second reference plane that are perpendicular to each other. The centerline of the first guide structure and the generatrix of the sharpest point of the puncture member are both on the first reference plane. That is, the line connecting the centerline of the side groove and the centerline of the puncture member and the line connecting the generatrix of the sharpest point of the puncture member and the centerline of the puncture member are 180° apart. The advantage of this design is that when the puncture member is puncturing, the sharpest point first penetrates the tissue, and the side groove then passes through the tissue, thus ensuring the success of the puncture. If the side groove coincides with or is close to the sharpest point, there is a risk that the primary or secondary septum tissue may be embedded in the side groove, resulting in puncture failure or serious damage to the foramen ovale tissue. The design of this application will not cause the above accidents.

[0049] 3. According to a concept of this application, the puncture member also includes a guide rail, and the blocking member also includes a boss provided on the side. The boss is connected to the guide rail, and the center line of the guide rail is on the second reference plane. That is, the plane formed by the center line of the guide rail and the center line of the puncture member is perpendicular to the first reference plane, thereby ensuring that the connecting hole of the blocking member is directly opposite the side groove. Since the connecting member moves along the side groove after passing through the connecting hole, the tightening of the fixing member can ensure that the connecting member will not interfere with the side groove, and there will be no problem of the connecting member being rolled into the puncture member along with the blocking member. On the other hand, the blocking member includes two connecting holes, and the connecting holes pass through the two connecting holes in sequence and are knotted. The knot is on the first reference plane, and the blocking member as a whole is parallel to or coincides with the second reference plane. Therefore, the knot will not occupy the position of the blocking member inside the puncture member. The positions of the various components inside the puncture member are reasonably arranged, minimizing the diameter of the puncture member, facilitating the puncture of the heart tissue, and the structural design is reasonable.

[0050] 4. According to a concept of this application, on the axial section of the nearest end of the first guide structure, the section of the second guide structure coincides with the section of the first guide structure. The second guide structure will not exceed the outer circumferential surface of the puncture member in the circumferential direction. Thus, the second guide structure plays the role of guiding the blocking member to move in one direction without increasing the diameter of the puncture member. The design is ingenious and reduces the operator's workload. On the other hand, in addition to providing a movement path for the connecting member, the first guide structure also provides a guide rail for the guide control mechanism, so that the guide control mechanism can only move along the guide rail, effectively preventing the blocking member from rotating.

[0051] 5. According to a concept of this application, the first connecting structure includes a first protrusion and a first groove, and the second connecting structure includes a second protrusion and a second groove. When the first connecting structure and the second connecting structure are connected, the first protrusion is at least partially fitted with the second groove, and the second protrusion is at least partially fitted with the first groove. At the same time, at least a portion of the outer surface of the blocking member is tangent to the inner surface of the piercing member. Thus, the first protrusion is subjected to the force of the second groove and the inner surface of the piercing member in the radial direction, and is restricted by the second protrusion in the axial direction, so that the first connecting structure cannot detach from the second connecting structure, nor can it move relative to the second connecting structure. In summary, the blocking member is restricted by the connecting control mechanism. When the connecting control mechanism is stationary, the blocking member will not move axially or rotate circumferentially, resulting in a good fixing effect and avoiding the problem of premature detachment of the blocking member.

[0052] 6. According to a concept of this application, the first connecting structure includes a mating part and a connecting part, and the second connecting structure includes a mating groove and a connecting channel. The mating part is confined within the mating groove, so that the first connecting structure and the second connecting structure are stably mated. The connecting part is partially sleeved within the connecting channel, which ensures that the blocking part will not shake arbitrarily, which is conducive to the stable conveying of the blocking part. At the same time, the connection control mechanism is easy to release from the blocking part, the operation is simple, and the movement of the blocking part is restricted. The design is ingenious and highly user-friendly.

[0053] 7. According to a concept of this application, the length of the blocking member is greater than the width and the height, and the height of the blocking piece is greater than the width of the side groove. The advantage of this design is that it effectively prevents the blocking member from detaching from the puncture piece at the side groove position, and does not cause premature detachment, thereby improving the safety of the operation.

[0054] The embodiments of this application can achieve other advantageous technical effects not listed one by one, which may be partially described below; and these other technical effects can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0055] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent from the following description in conjunction with the accompanying drawings; and embodiments of this application can be better understood, in which:

[0056] Figures 1a-1d This is a schematic diagram of the overall structure of the release mechanism in Embodiment 1 of the present invention.

[0057] Figures 2a-2c This is a schematic diagram of a puncture device with two blocking elements inside, as shown in Embodiment 1 of the present invention.

[0058] Figures 3a-3g This is a schematic diagram of the surgical procedure steps in Embodiment 1 of the present invention.

[0059] Figures 4a-4f This is a schematic diagram of the structure in Embodiment 2 of the present invention.

[0060] The features represented by the numbers in the attached diagram are as follows:

[0061] 1-Implant, 11-Blocking element, 111-First connecting structure, 112-First protrusion, 113-First groove, 114-Connecting hole, 115-Matching part, 116-Connecting part, 117-Boss, 12-Connecting element, 13-Closed sleeve, 2-Delivery system, 21-Punch element, 211-First guide structure, 212-Guide rail, 22-Fixing element, 23-Pushing structure, 231-Separation structure, 24-First reference surface, 25-Second reference surface, 26-Pushing element, 3-Control device, 31-Connecting control mechanism, 311-Second connecting structure, 312-Second protrusion, 313-Second groove, 314-Matching groove, 315-Connecting channel, 316-Supporting surface, 32-Guiding control mechanism, 321-Second guide structure. Detailed Implementation

[0062] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0063] It should be understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0064] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0065] In this application, the terms "proximal" or "proximal" refer to the end or side closer to the surgeon, and "distal" or "distal" refer to the end or side farther from the surgeon.

[0066] In this application, the term "first reference plane" refers to a reference plane of the conveying system, specifically the plane containing the centerline of the first connecting structure of the piercing member and the generatrix of the sharpest point of the piercing member.

[0067] In this application, the term "second reference plane" refers to another reference plane of the conveying system, specifically a plane that is parallel to or coincides with the plane containing the length and width of the blocking member, and the second reference plane is perpendicular to the first reference plane.

[0068] In the existing technology, there are problems such as implantation failure caused by the blocking component prematurely disengaging due to lack of control, and interference between the connecting component and the puncture component caused by the easy rotation of the blocking component.

[0069] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0070] Example 1

[0071] like Figures 1a-1c The illustration shows a tissue puncture closure device including a control device 3 according to an embodiment of this application, comprising a delivery system 2 and an implant 1 for closing tissue defects. The control device 3 includes a connection control mechanism 31 and a guide control mechanism 32. The implant 1 includes a blocking member 11 and a connector 12 connected to the blocking member 11. The delivery system 2 includes a puncture member 21 and a pusher 26 for pushing the blocking member 11. The connection control mechanism 31 includes a first connection structure 111 disposed on the blocking member 11 and a pusher 26 disposed on the pusher 21. The second connecting structure 311 is detachably connected to the first connecting structure 111 on the delivery member 26. The blocking member 11 and the pushing member 26 are slidably sleeved in the puncture member 21. The guiding control mechanism 32 includes a first guiding structure 211 disposed on the distal part of the puncture member 21 and a second guiding structure 321 disposed on the blocking member 11 and / or the pushing member 26. The connecting control mechanism 31 and the guiding control mechanism 32 respectively restrict the axial movement and circumferential rotation of the blocking member 11 relative to the puncture member 21.

[0072] In this first embodiment, the first guide structure 211 is a strip-shaped side groove provided on the piercing member 21, and the second guide structure 321 is a slider provided on the blocking member 11 or the pushing member 26. Furthermore, the first guide structure 211 provides an axial sliding track for the second guide structure 321, such as... Figures 1b-1d As shown.

[0073] In this first embodiment, the second guide structure 321 is a slider disposed on the pusher 26, and the slider and the side groove are in clearance fit.

[0074] In this first embodiment, the centerline of the side groove 211 and the generatrix of the sharpest point of the piercing member 21 are on the same plane, such as... Figure 1d As shown.

[0075] In this first embodiment, the blocking member 11 includes two connecting holes 114, and the connecting member 12 passes through the two connecting holes 114 in sequence and is knotted; and, during the process of the pushing member 26 pushing or pulling the blocking member 11, the connecting member 12 moves along the first guide structure 211.

[0076] In this first embodiment, the first connecting structure 111 includes a first protrusion 112 and a first groove 113, and the second connecting structure 311 includes a second protrusion 312 and a second groove 313; furthermore, when the first connecting structure 111 and the second connecting structure 311 are connected, the first protrusion 112 at least partially fits against the second groove 313, and the second protrusion 312 at least partially fits against the first groove 113. Figure 1b and 1c As shown.

[0077] In this first embodiment, the first protrusion 112 is crescent-shaped and has a smooth surface without sharp corners, such as... Figure 1c As shown.

[0078] In this first embodiment, the first groove 113 interacts with the second protrusion 312, the first protrusion 112 interacts with the second groove 313, the first connecting structure 111 and the second connecting structure 311 restrict each other, the control device 3 does not rotate, the blocking member 11 cannot rotate, thus avoiding the phase change of the blocking plate.

[0079] In one embodiment, the second protrusion 312 can move axially a certain distance within the first groove 113.

[0080] In this first embodiment, the length of the blocking member 11 is greater than the width of the blocking member 11, and the width of the blocking member 11 is greater than the height of the blocking member 11; and the width-to-height ratio of the blocking member 11 is 1.2 to 3.

[0081] In this first embodiment, the length of the blocking member 11 is 5mm, the width is 0.5mm, and the height is 0.25mm.

[0082] In this first embodiment, the height of the blocking member 11 is greater than the width of the side groove.

[0083] In this first embodiment, the implant 1 includes two blocking elements 11, and the delivery system 2 includes one or two puncture elements 21, such as... Figures 1a-1c and Figures 2a-2c As shown; and the puncture member 21 delivers two blocking members 11 through the secondary septum and the primary septum respectively.

[0084] In this first embodiment, the implant 1 further includes a closure sleeve 13, and the delivery system 2 further includes a fixing member 22 and a pushing structure 23; furthermore, the fixing member 22 is connected to the connecting member 12, and the pushing structure 23 is used to push the closure sleeve 13 toward the distal end, such as... Figure 1a and Figure 2a As shown.

[0085] In this first embodiment, during pre-installation, the closing sleeve 13 is fitted over the connector 12 or the fixing member 22.

[0086] In this embodiment, the implant 1 includes two connectors 12, and the two ends of the connectors 12 are connected to the blocking member 11 and the fixing member 22, respectively.

[0087] In this first embodiment, the blocking member 11 has a connecting hole 114 inside, and the connecting hole 114 is connected to the distal end of the connecting member 12, such as... Figure 1b and 1c As shown.

[0088] In this first embodiment, the distal end of the puncture member 21 is sharp.

[0089] In this first embodiment, the centerline of the connecting hole 114 is on the center plane of the first guide structure 211, that is, the connecting hole 114 is visible through the first guide structure 211, as shown below. Figure 1b As shown.

[0090] In this first embodiment, after the blocking member 11 is released to the target position, the closing sleeve 13 is moved distally. The smaller the distance between the distal end of the connecting member 12 and the closing sleeve 13, the closer the two blocking members 11 are, and the closer the secondary and primary spacers are. Figures 3a-3g As shown.

[0091] In this first embodiment, the pushing structure 23 includes a separating structure 231. When the closed sleeve is close to the interatrial septum and no longer needs to move proximally, the separating structure 231 is operated to cut off the connector 12 located proximally to the closed sleeve 13. Figure 1a As shown.

[0092] In this first embodiment, the connector 12 is linear and made of metal.

[0093] In this first embodiment, at least a portion of the outer surface of the blocking member 11 is tangent to the inner surface of the piercing member 21.

[0094] The exemplary operation process of the closed system in this embodiment is as follows:

[0095] (1) The delivery system 2 enters the right atrium via the femoral vein approach, and then moves to the position of the patent foramen ovale between the secondary septum and the primary septum near the interatrial septum, such as... Figure 3a As shown;

[0096] (2) The puncture member 21 is operated to pass through the secundum and primary septum tissues respectively, and then the connection control mechanism 31 is pushed to release the blocking member 11 into the left atrium. The guide control mechanism 32 ensures that the blocking member 11 will not rotate. When the first connection structure 111 disengages from the puncture member 21, the second structure 311 disengages from the first structure 111, as follows. Figures 3b-3d As shown.

[0097] (3) Retrieve the puncture member 21, then tighten or fix the fixing member 22 to tighten the connecting member 12, and operate the pushing structure 23 to push the closing sleeve 13 toward the distal end, so that the primary septum and the secondary septum move closer to each other, such as Figure 3e and 3f As shown;

[0098] (4) Observe the release of the shunt at the foramen ovale of the right atrium, and operate the fixation member 22 and the pushing structure 23 until there is no blood flow between the primary septum and the secondary septum;

[0099] (5) When the closed sleeve 13 is close to the interatrial septum and no further movement towards the proximal end is required, the separation structure 231 is operated to cut off the connector located near the proximal end of the closed sleeve, such as... Figure 3g As shown.

[0100] Example 2:

[0101] The difference from Example 1 is as follows:

[0102] In this second embodiment, the first connecting structure 111 and the second connecting structure 311 are connected in different ways; and the puncture member 21 is also provided with a guide rail 212, which further prevents the blocking member 11 from rotating within the puncture member 21.

[0103] The composition and connection method of each component in this embodiment will be described in detail below with reference to the accompanying drawings:

[0104] In this second embodiment, as Figures 4a-4fThe illustration shows a tissue puncture closure device including a control device 3 according to an embodiment of this application, comprising a delivery system 2 and an implant 1 for closing tissue defects. The control device 3 includes a connection control mechanism 31 and a guide control mechanism 32. The implant 1 includes a blocking member 11 and a connector 12 connected to the blocking member 11. The delivery system 2 includes a puncture member 21 and a pusher 26 for pushing the blocking member 11. The connection control mechanism 31 includes a first connection structure 111 disposed on the blocking member 11 and a pusher 26 disposed on the pusher 21. The second connecting structure 311 is detachably connected to the first connecting structure 111 on the delivery member 26. The blocking member 11 and the pushing member 26 are slidably sleeved in the puncture member 21. The guiding control mechanism 32 includes a first guiding structure 211 disposed on the distal part of the puncture member 21 and a second guiding structure 321 disposed on the blocking member 11 and / or the pushing member 26. The connecting control mechanism 31 and the guiding control mechanism 32 respectively restrict the axial movement and circumferential rotation of the blocking member 11 relative to the puncture member 21.

[0105] In this second embodiment, the first connecting structure 111 includes a mating part 115 and a connecting part 116, and the second connecting structure 311 includes a mating groove 314 and a connecting channel 315; furthermore, when the first connecting structure 111 and the second connecting structure 311 are connected, the mating part 115 is at least partially fitted with the mating groove 314, and the connecting part 116 is at least partially sleeved within the connecting channel 315, such as... Figures 4b-4e As shown.

[0106] In this second embodiment, the mating part 115 and the connecting part 116 are combined in a hammer shape, as shown below. Figure 4d As shown.

[0107] In this second embodiment, the connecting channel 315 includes a support surface 316, such as... Figure 4e As shown, the support surface 316 is in contact with the connecting part 116, and the support surface 316 acts on the connecting part 116 to prevent the connecting part 116 from rotating, thus ensuring that the blocking member 11 will not rotate.

[0108] In this second embodiment, the mating groove 314 and the puncture member 21 cooperate to confine the connecting part 116 within the puncture member.

[0109] In this second embodiment, the conveying system 2 includes a first reference plane 24 and a second reference plane 25 that are perpendicular to each other; and the center line of the first guide structure 211 and the generatrix of the sharpest point of the piercing member 21 are both on the first reference plane 24.

[0110] In this second embodiment, the puncture member 21 further includes a guide rail 212, and the blocking member 11 further includes a boss 117 disposed on the side, the boss 117 being connected to the guide rail 212; and the centerline of the guide rail 212 is on the second reference plane 24, such as... Figure 1d and 4f As shown, during pre-installation, the blocking member 11 is placed inside the puncture member 21 along the guide rail 212, ensuring that the blocking member 11 will not rotate inside the puncture member 21.

[0111] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0112] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A tissue puncture closure device including a control mechanism, comprising a delivery system and an implant for closing tissue defects, characterized in that: The control device includes a connection control mechanism and a guide control mechanism. The implant includes a blocking member and a connector connected to the blocking member. The delivery system includes a puncture member and a pusher member that pushes the blocking member. The connection control mechanism includes a first connecting structure disposed on the blocking member and a second connecting structure disposed on the pusher member and detachably connected to the first connecting structure. The blocking member and the pusher member are slidably fitted inside the puncture member. The guide control mechanism includes a first guide structure disposed on the distal portion of the puncture member and a second guide structure disposed on the blocking member and / or the pusher member. The connection control mechanism and the guide control mechanism respectively restrict the axial movement and circumferential rotation of the blocking member relative to the puncture member. The first guide structure is a strip-shaped side groove disposed on the puncture member, and the second guide structure is a protrusion or slider disposed on the blocking member or the pusher member. Furthermore, the first guide structure provides an axial sliding track for the second guide structure.

2. The tissue puncture closure device with a control device according to claim 1, characterized in that: The delivery system includes a first reference plane and a second reference plane that are perpendicular to each other; and the center line of the first guide structure and the generatrix of the sharpest point of the puncture member are both on the first reference plane.

3. The tissue puncture closure device with a control device according to claim 2, characterized in that: The puncture member further includes a guide rail, and the blocking member further includes a boss disposed on the side, the boss being connected to the guide rail; and the centerline of the guide rail is on the second reference plane.

4. The tissue puncture closure device with a control device according to claim 1, characterized in that: The blocking member includes two connecting holes, and the connecting member passes through the two connecting holes in sequence and is knotted; and, during the process of the pusher pushing or pulling the blocking member, the connecting member moves along the first guide structure.

5. A tissue puncture closure device with a control device according to claim 1, characterized in that: The first connecting structure includes a first protrusion and a first groove, and the second connecting structure includes a second protrusion and a second groove; and when the first connecting structure is connected to the second connecting structure, the first protrusion is at least partially attached to the second groove, and the second protrusion is at least partially attached to the first groove.

6. A tissue puncture closure device including a control device according to claim 1, characterized in that: The first connecting structure includes a mating part and a connecting part, and the second connecting structure includes a mating groove and a connecting channel; and when the first connecting structure and the second connecting structure are connected, the mating part is at least partially fitted with the mating groove, and the connecting part is at least partially sleeved in the connecting channel.

7. A tissue puncture closure device with a control device according to claim 1, characterized in that: The length of the blocking member is greater than the width of the blocking member, the width of the blocking member is greater than the height of the blocking member, and the height of the blocking member is greater than the width of the side groove; and the width-to-height ratio of the blocking member is 1.2 to 3.

8. A tissue puncture closure device with a control device according to claim 1, characterized in that: The implant also includes a closure sleeve, and the delivery system also includes a fixation element and a pushing structure; the fixation element is connected to the connector, and the pushing structure is used to push the closure sleeve toward the distal end.

9. A tissue puncture closure device including a control device according to claim 8, characterized in that: During pre-assembly, the closing sleeve is fitted over the connector or the fixing member.

10. A tissue puncture closure device including a control device according to claim 8, characterized in that: The implant includes a connector, the two ends of which are respectively connected to the two blocking members; or, the implant includes two connectors, the two ends of which are respectively connected to the blocking member and the fixing member.

11. A tissue puncture closure device including a control device according to claim 1, characterized in that: The implant includes two blocking elements, and the delivery system includes one or two puncture elements; and the puncture elements deliver the two blocking elements through the secundum and primordial septum respectively.

12. A tissue puncture closure device with a control device according to claim 1, characterized in that: At least a portion of the outer surface of the blocking member is tangent to the inner surface of the puncturing member.

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