Closing instrument convenient for double-tissue fitting acupuncture

Abstract

The invention relates to the field of medical instruments, in particular to a closing instrument convenient for double-tissue fitting and needling, the closing instrument is used for closing a channel between first tissue and second tissue, the closing instrument comprises a guide part, a needle hiding tube, a needling assembly and a guide limiting structure, the guide limiting structure comprises a controllable guide unit, an adaptive supporting unit, a connecting unit and a pushing part, the controllable guide unit is connected with the far-end part of the needle hiding tube, and the controllable guide unit and the guide piece are attached to the two end faces of the first tissue respectively; in addition, the adaptive supporting unit is attached to the second tissue and deforms according to the shape of the second tissue, and the connecting unit provides supporting force for the adaptive supporting unit when the adaptive supporting unit is attached to the second tissue.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a closure device that facilitates double-tissue acupuncture. Background Art

[0002] The foramen ovale is a physiological passageway in the atrial septum during embryonic development. Between 5 and 7 months after birth, the septum secundum and septum primum adhere and fuse to form a permanent atrial septum in most individuals. If this fails to fuse, a patent foramen ovale (PFO) forms. In approximately 25% to 34% of adults, the two layers of the septum in the fossa ovale fail to fully fuse, leaving a permanent, slit-like defect between them. Because the volume shunt through a PFO is so small, it was long believed to be clinically insignificant. However, recent studies have revealed that patients with PFOs have a several-fold increased risk of stroke, migraine, peripheral arterial embolism, and decompression sickness compared to the general population. The pathogenic role of PFOs has garnered considerable attention from experts and researchers. Common treatments for PFO closure include implanting an occluder disc or suturing the patent passageway. However, because occluder disc implantation leaves a large, non-disintegrating device in the heart, it can hinder patient recovery and interfere with other surgical procedures. Therefore, suturing is often recommended in clinical practice.

[0003] Patent 202211628104.8 discloses a device for tissue closure, including a delivery catheter, an implant for closing tissue defects, and a guiding mechanism, a puncture mechanism and a positioning mechanism arranged in the delivery catheter, and the positioning mechanism can provide support for the puncture mechanism when it punctures the tissue to be closed back and forth; however, this solution has the following defects: First, the positioning mechanism supports the secondary septum and the primary septum through the upper area and the lower area at the same time, but since the upper area and the lower area cannot provide support independently, when the lower area is adjusted to support the primary septum, the upper area deflects at the same time, affecting the position of the bending section on the secondary septum, affecting the second puncture effect while involving the first puncture area; secondly, the positioning bracket and the clamp require at least two pipes for delivery. Such a design will increase the size of the delivery system, which is not conducive to the patient's later recovery.

[0004] In summary, the existing technology has the following problems that need to be urgently solved: First, when puncturing the second tissue in the existing technology, it will affect the puncture point of the first tissue and cause the puncture tube to shake or move; second, in order to clamp the first tissue and the second tissue in the existing technology, two tubes need to be used to control the clamping parts, resulting in an increase in the diameter of the delivery catheter; third, it is difficult for the existing technology to naturally fit the flexible second tissue. Summary of the Invention

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

[0006] One of the purposes of this application is to overcome the shortcomings of the existing technology. In order to address the problems in the existing technology that the puncture instrument affects the puncture effect of the first tissue and the stability of the puncture tube when puncturing the second tissue, and the problem that two or more tubes are set to control the clamping parts, resulting in the expansion of the delivery tube size, a closing device is provided that facilitates double-tissue bonding and puncture.

[0007] The object of the present invention is achieved through the following solutions: A closing device that facilitates double-tissue acupuncture and is used to close a channel between a first tissue and a second tissue, comprising a guide member, a needle-containing tube, a needle-puncture assembly and a guide and limiting structure, wherein the guide and limiting structure comprises a controllable guiding unit, an adaptive supporting unit, a connecting unit and a pushing member, wherein the controllable guiding unit is connected to the distal end portion of the needle-containing tube, and the controllable guiding unit and the guide member respectively adhere to the two end surfaces of the first tissue; and the adaptive supporting unit adheres to the second tissue and deforms in accordance with the shape of the second tissue, and the connecting unit provides supporting force for the adaptive supporting unit when the adaptive supporting unit adheres to the second tissue.

[0008] The purpose of the present invention can be further achieved by the following technical solutions: In one embodiment, the adaptive support unit includes an arc connection portion, a support portion and a retaining portion; and the arc connection portion is connected to the connecting unit, the support portion provides a support area for the second tissue, and the retaining portion is located in the proximal direction of the connecting unit in a natural state.

[0009] In one embodiment, the controllable guiding unit, the adaptive supporting unit and the connecting unit are an integrally formed structure.

[0010] In one embodiment, the connecting unit includes a plurality of cutouts to prevent excessive stress concentration.

[0011] In one embodiment, when performing the second puncture, part of the needle assembly abuts against the distal surface of the second tissue, and the support portion abuts against the proximal surface of the second tissue.

[0012] In one embodiment, the adaptive support unit is in the shape of a strip.

[0013] In one embodiment, the adaptive support unit is covered with a membrane.

[0014] In one embodiment, the controllable guiding unit and the adaptive supporting unit are located on either side of a central axis of the closure device.

[0015] In one embodiment, the adaptive support unit includes a plurality of longitudinally arranged skeletons, and the plurality of skeletons are located at the front and rear sides relative to the central axis of the conveying tube, and the plurality of skeletons form a three-dimensional support surface.

[0016] In one embodiment, there is a certain distance between adjacent frames; and the distance between two adjacent frames located in the middle can facilitate the separation of the needle assembly from the implant loaded in the closure device when the needle assembly is withdrawn.

[0017] In one embodiment, the supporting and fitting forces of the multiple skeletons are different. The skeleton located in the middle is used to fit the middle part of the second tissue, and the skeletons located on both sides are used to fit both sides of the second tissue.

[0018] In one embodiment, the flexibility of the skeleton in the middle is greater than the flexibility of the skeletons at both sides, and the flexibility of the skeleton gradually increases from the middle to the both sides.

[0019] In one embodiment, the distance between the central frame and the central axis of the closure device is greater than the distance between the central axis of the closure device and the frames at both sides.

[0020] In one embodiment, the guide and limiting structure is provided with an image-recognizable structure so as to confirm under imaging conditions that the needle assembly passes through the first tissue or the second tissue along a preset track.

[0021] In one embodiment, an image-recognizable structure is provided on the skeleton.

[0022] In one embodiment, the guide member includes a transition structure, which is in the shape of a rugby ball or a cone, and is planar or three-dimensional.

[0023] In one embodiment, when the transition structure reaches the lower edge of the first tissue, the controllable guiding unit is released to open.

[0024] In one embodiment, when the adaptive support unit is in contact with the second tissue, the connecting unit and the pushing member provide supporting force for the adaptive support unit; and the connecting unit supports the arc-connecting portion, and the pushing member supports the retaining portion.

[0025] In one embodiment, when the adaptive support unit is in contact with the second tissue, the second tissue applies a force in a proximal direction to the support portion, and the pushing member applies a force in a distal direction to the retaining portion.

[0026] In one embodiment, the holding portion is a free end of the adaptive support unit; and the holding portion further includes an anchoring member, which is adapted to and relatively fixed to the connecting unit.

[0027] In one embodiment, the anchoring element is in the form of an arc surface.

[0028] In one embodiment, the device further comprises a guide member and a delivery tube, wherein the pushing member enters the target position along the guide member, and the needle-hiding tube and the pushing member are pre-installed in the delivery tube.

[0029] In one embodiment, the holding portion includes a control locking unit, and the distal end of the delivery tube is connected to the control locking unit to stabilize the posture of the adaptive supporting unit.

[0030] In one embodiment, the distal end of the delivery tube being locked into the control locking unit can constrain the adaptive supporting unit to keep it stable.

[0031] In one embodiment, when the guiding and limiting structure is pre-installed in the delivery tube, the arc-connecting portion, the supporting portion, and the retaining portion are sequentially arranged from the distal end toward the proximal end.

[0032] In another embodiment, the retaining portion, the supporting portion, and the arc-connecting portion are sequentially arranged from the distal end toward the proximal end.

[0033] In one embodiment, the retaining portion includes a sleeve member, and the sleeve member is slidably sleeved outside the pushing member along the central axis of the closing device.

[0034] In one embodiment, the sleeve is operated to reciprocate to change the shape of the adaptive support unit and / or change the distance between the central axis of the closure device and the support portion, thereby being able to adapt to primary septal tissues of different sizes.

[0035] In one embodiment, the sleeve is operated to reciprocate to change the shape of the adaptive support unit and / or change the distance between the central axis of the closure device and the support portion.

[0036] In one embodiment, the curvature of the adaptive support unit can be adjusted to regulate the support force of the needle assembly during puncturing the second tissue and the relative distance between the puncture point and the guide member to ensure that the second tissue is punctured.

[0037] In one embodiment, the controllable guiding unit includes an elastic guide member and a control member, and the control member is pulled to change the swing angle of the elastic guide member; and the elastic guide member also includes a limiting opening, and the distal end of the needle-hiding tube is arranged in the limiting opening.

[0038] In one embodiment, in a natural state, the elastic guide remains parallel to a center line of the connecting unit.

[0039] In one embodiment, when the control member is pulled, the elastic guide member moves toward the proximal end.

[0040] In one embodiment, the elastic guide and the leading member fix, constrain, or clamp the first tissue.

[0041] In one embodiment, the needle puncture assembly includes a first needle puncture part and a second needle puncture part arranged in the first needle puncture part; when puncturing the first tissue, the distal end of the second needle puncture part exceeds the first needle puncture part, and the second needle puncture part and the first needle puncture part pass through the first tissue in sequence.

[0042] In one embodiment, the hole left by the second needle puncture part and the first needle puncture part sequentially passing through the first tissue is smaller than the hole left by the first needle puncture part directly passing through the first tissue.

[0043] In one embodiment, the first needle-piercing part includes a first bend adjustment tube and a second bend adjustment tube sleeved in and connected to the first bend adjustment tube; the first bend adjustment tube and the second bend adjustment tube are bent in a natural state, the first bend adjustment tube includes a first rib arranged on the small bend side, and the second bend adjustment tube includes a second rib arranged on the large bend side.

[0044] In one embodiment, the first bend adjusting pipe further includes a first slit arranged opposite to the first rib, and the first slit occupies 70% to 90% of the circumference of the first bend adjusting pipe.

[0045] In one embodiment, the second bend adjusting pipe further includes a second slit arranged opposite to the second rib, and the second slit occupies 70% to 90% of the circumference of the second bend adjusting pipe.

[0046] In one embodiment, the second needle-piercing part is pre-installed in the second bending adjustment tube, and the second rib supports the second needle-piercing part when the second needle-piercing part reciprocates.

[0047] In one embodiment, a suture is pre-installed in the second needle-piercing portion, and the suture is used to suture the first tissue and the second tissue.

[0048] In one embodiment, the first bending adjustment tube includes a first bending adjustment unit and a third bending adjustment unit, the second bending adjustment tube includes a second bending adjustment unit and a fourth bending adjustment unit, the first rib is located in the first bending adjustment unit, and the second rib is located in the second bending adjustment unit.

[0049] In one embodiment, the first bending adjustment unit and the second bending adjustment unit are naturally bent inward, and the first bending adjustment unit cannot be bent outward from a vertical state.

[0050] In one embodiment, the first bending adjustment pipe and the second bending adjustment pipe are both metal cutting pipes.

[0051] In one embodiment, the first tissue is secondary septal tissue and the second tissue is primary septal tissue.

[0052] In one embodiment, the inner side is the side close to the lesion, and the outer side is the side away from the lesion.

[0053] Compared with the prior art, the advantages of the technical solution of this application include at least the following: 1. The existing closure device uses a clamp and a positioning bracket to support the secondary septum while also using the positioning bracket to support the primary septum. When puncturing the primary septum, adjusting the positioning bracket will change the relative position of the positioning bracket and the secondary septum, thereby pulling the secondary septum and causing damage, and also changing the angle of the bending section at the first puncture point, making the bending section unretainable, further affecting the accuracy of puncturing the primary septum. On the other hand, in order to control the clamp and the positioning bracket, two tubes are deliberately used. When the positioning bracket cannot be kept in contact with the tissue, the diameter of the delivery tube is enlarged, further reducing the success rate of the operation. The present application avoids the above problems. First, the guide and restriction structure of the present application includes a controllable guide unit, an adaptive support unit, a connecting unit and a pushing member. The controllable guide unit and the guide member are connected. Cooperating to provide support and clamping force for the secondary septum, the adaptive support unit and the needle assembly respectively fit the two end faces of the primary septum to facilitate the second puncture. The components providing support force for the first puncture and the second puncture are not repeated, so the secondary septum will not be affected during the second puncture, and there is no need to adjust the position of the guide and limiting structure relative to the guide member for the first puncture and the second puncture. After the guide and limiting structure reaches the target position, it has already fit the secondary septum and the primary septum; secondly, the controllable guide unit and the adaptive support unit are connected to the connecting unit, and the connecting unit is connected to the pushing member. The controllable guide unit and the adaptive support unit supporting the secondary septum and the primary septum are only transported to the foramen ovale lesion through the pushing member, which reduces the diameter of the delivery tube, not only facilitates the access, but also is beneficial to the patient's recovery.

[0054] 2. Different from the existing technology, the adaptive support unit of the present application includes multiple longitudinally arranged skeletons, and the multiple skeletons are separated on the front and rear sides relative to the central axis of the delivery tube. The multiple skeletons form a three-dimensional support surface, so that the adaptive support unit can adaptively move in the oval foramen, and the second needle-piercing part can perform puncture near the middle position of the adaptive support unit, with good puncture effect.

[0055] 3. Different from the prior art, the adaptive support unit of the present application includes an arc connection part, a support part and a retaining part. The arc connection part is connected to the connecting unit. On the one hand, it ensures that the adaptive support unit can smoothly enter the lesion along with the pushing member, and on the other hand, it can obtain the supporting force of the connecting unit to ensure that the support part will not be excessively deformed when fitting the primary septum; the support part does not need to directly contact the pushing member, so that a certain gap will be maintained between the support part and the pushing member, and the primary septum can be pushed toward the left atrium, reducing the activity space of the primary septum, which is convenient for restricting the primary septum. At the same time, the support part supports the primary septum without affecting any progress of the secondary septum during the operation; the retaining part provides support force at the proximal position, so that both ends of the support part can obtain support force, ensuring the fitting effect of the support part and the primary septum, and facilitating the second puncture.

[0056] 4. Different from the prior art, the retaining portion of the present application further includes a sleeve member, which is sleeved outside the push member and can perform reciprocating axial movement relative to the push member. Combined with the adaptive support unit having good deformation characteristics, the movement of the sleeve member can change the shape of the adaptive support unit, thereby adapting to primary septa of different shapes, resisting or fitting the primary septa, and also adapting to primary septa with a large distance from secondary septa. It has strong adaptability and high promotion value.

[0057] 5. Different from the prior art, the first needle insertion part of the present application includes two cutting tubes, a first bending adjustment tube and a second bending adjustment tube. The two can bend by relative movement, and there is no need for a guide wire to pull to adjust the curvature of the first needle insertion part, thereby avoiding damage to the first puncture point by the guide wire; secondly, since the first bending adjustment unit located on the left atrial surface has and only has one bending direction (towards the inside), the first needle insertion part will not twist during puncture, ensuring that the second needle insertion part will puncture within the plane where the center line of the first needle insertion part is located, with high accuracy; thirdly, since the second rib of the second bending adjustment tube is arranged on the greater curvature side, the second rib can resist the outward force exerted on the second bending adjustment tube when the second needle insertion part punctures the secondary septum, and the second bending adjustment tube is also covered with the first bending adjustment tube, the holding force of the first needle insertion part is strong enough, which will not cause the first needle insertion part to shake during the movement of the end of the second needle insertion part toward the primary septum, thereby ensuring the second puncture.

[0058] 6. Different from the prior art, the arc connection portion of the present application and the proximal portion of the controllable guiding unit overlap in the axial direction, which can form a clamping force on the secondary septum tissue and play a role in assisting in fixing the secondary septum tissue.

[0059] 7. Different from the prior art, the needle-hidden tube of the present application is connected to a controllable guiding unit, and the distal end of the needle-hidden tube is arranged in a limiting opening of the elastic guiding member. When the elastic guiding member is in close contact with the secondary septum, the needle-hidden tube is perpendicular to the secondary septum, so that the first needle-hidden part can be inserted vertically, and the hole left on the secondary septum is small; and the second needle-hidden part can also be perpendicular to the supporting part and inserted vertically on the primary septum. Both punctures can be inserted vertically, thereby enhancing the effectiveness of suturing.

[0060] 8. Different from the prior art, when the adaptive support unit sets the skeleton, the preset shapes and flexibility of different skeletons are different. The flexibility of the skeleton located in the middle is greater than the flexibility of the skeleton located on both sides. The flexibility of the skeleton gradually increases from the middle to the two sides. The distance between the skeleton located in the middle and the central axis of the closure device is greater than the distance between the skeleton located on both sides and the central axis of the closure device. This design can reduce the damage to the primary septum tissue that first contacts the skeleton, and the primary septum is gradually pushed toward the left atrium. The skeletons with good rigidity on both sides can stably support the primary septum.

[0061] The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below; and they can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent and the embodiments of the present application can be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 Schematic diagram of the overall structure of the closure device of the present invention.

[0063] Figure 2 and Figure 3 It is a structural schematic diagram of the guiding and limiting structure of the present invention.

[0064] Figure 4 Schematic diagram of the control locking unit of the present invention.

[0065] Figure 5 and Figure 6 It is a schematic structural diagram of the first bend regulating pipe and the second bend regulating pipe of the present invention.

[0066] Figure 7 This is a diagram of the internal layout of the needle assembly of the present invention.

[0067] Figures 8 to 13 Schematic diagram of the operating steps of the present invention.

[0068] Figures 14 to 17 This is another embodiment of the present invention.

[0069] Figure 18 and Figure 19 This is another embodiment of the present invention.

[0070] The features indicated by the numbers in the accompanying drawings are as follows: 1-first tissue, 2-second tissue, 3-needle tube, 4-needle assembly, 41-first needle part, 411-first bending tube, 4111-first bending unit, 4112-third bending unit, 412-second bending tube, 4121-second bending unit, 4122-fourth bending unit, 413-first rib, 414-first slit, 4141-first opening, 4142-first limiting part, 415-second rib, 416-second slit, 42-second needle assembly Needle part, 5-guiding and limiting structure, 51-controllable guiding unit, 511-elastic guiding member, 512-control member, 513-limiting port, 52-adaptive supporting unit, 521-arc connecting part, 522-supporting part, 523-holding part, 524-anchoring member, 525-control locking unit, 526-sleeve connecting member, 527-skeleton, 53-connecting unit, 531-incision, 54-pushing member, 6-pilot member, 61-transition structure, 7-delivery tube, 8-suture member. DETAILED DESCRIPTION

[0071] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0072] It should be understood that the phrases and terms used herein are for descriptive purposes only and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0073] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0074] In the present application, the term “proximal end” or “proximal side” refers to an end or side closer to a surgical operator, and “distal end” or “distal side” refers to an end or side farther from a surgical operator. Example 1

[0075] like Figure 1As shown, when the present invention is used to close the foramen ovale tissue, a closing device for facilitating double-tissue acupuncture according to an embodiment of the present application is illustrated, which is used to close the channel between the first tissue 1 and the second tissue 2, including a guide member 6, a needle tube 3, a needle assembly 4 and a guide and limiting structure 5, wherein the guide and limiting structure 5 includes a controllable guiding unit 51, an adaptive supporting unit 52, a connecting unit 53 and a pushing member 54, wherein the controllable guiding unit 51 is connected to the distal end portion of the needle tube 3, and the controllable guiding unit 51 and the guide member 6 are respectively in contact with the two end faces of the first tissue 1; and the adaptive supporting unit 52 is in contact with the second tissue 2 and deforms in accordance with the shape of the second tissue 2, and the connecting unit 53 provides support force for the adaptive supporting unit 52 when the adaptive supporting unit 52 is in contact with the second tissue 2.

[0076] In the first embodiment, the adaptive support unit 52 includes an arc connection portion 521, a support portion 522 and a retaining portion 523. The arc connection portion 521 is connected to the connecting unit 53. The support portion 522 provides a support area for the second tissue 2. The retaining portion 523 is naturally located in the proximal direction of the connecting unit 53. Figure 2 shown.

[0077] In the first embodiment, the adaptive support unit 52 is in a strip shape. Figure 3 shown.

[0078] In the first embodiment, the controllable guiding unit 51 , the adaptive supporting unit 52 and the connecting unit 53 are an integrally formed structure.

[0079] In the first embodiment, the connecting unit 53 includes a plurality of cutouts 531 to prevent excessive stress concentration. Figure 3 shown.

[0080] In the first embodiment, when the second puncture is performed, part of the needle assembly 4 is against the distal surface of the second tissue 2, and the support portion 522 is against the proximal surface of the second tissue 2. Figure 11 shown.

[0081] In the first embodiment, a developing structure is provided on the surface of the support portion 522 . When the first needle puncture portion 41 is perpendicular to the support portion 522 , the second needle puncture portion 42 is operated to puncture the second tissue 2 .

[0082] In this embodiment 1, when the adaptive support unit 52 fits the second tissue 2, the connecting unit 53 and the pushing member 54 provide support force for the adaptive support unit 52; and the connecting unit 53 supports the arc-connecting portion 521, and the pushing member 54 supports the retaining portion 523.

[0083] In the first embodiment, when the adaptive support unit 52 is attached to the second tissue 2 , the second tissue 2 applies a proximal force to the support portion 522 , and the pusher 54 applies a distal force to the retaining portion 523 .

[0084] In the first embodiment, the holding portion 523 is the free end of the adaptive support unit 52 ; and the holding portion 523 further includes an anchor 524 , which is adapted to and relatively fixed to the connecting unit 53 .

[0085] In the first embodiment, the anchoring member 524 is in the form of an arc surface.

[0086] In the first embodiment, a pilot element 6 and a delivery pipe 7 are also included. Figure 8 As shown, the pusher 54 enters the target position along the guide member 6, and the needle tube 3 and the pusher 54 are pre-installed in the delivery tube 7; and the holding portion 523 includes a control locking unit 525, and the distal end of the delivery tube 7 is connected to the control locking unit 525 to stabilize the posture of the adaptive support unit 52, as shown in FIG. Figure 4 shown.

[0087] In the first embodiment, the guide member 6 is in the shape of a wire or a rod.

[0088] In the first embodiment, the distal end of the delivery tube 7 is inserted into the control locking unit 525 to restrict the adaptive support unit 52 so that it remains stable; and the control locking unit 525 is in the shape of a groove or a matching slot.

[0089] In the first embodiment, when the guiding and limiting structure 5 is pre-installed in the delivery tube 7 , the arc-connecting portion 521 , the supporting portion 522 , and the retaining portion 523 are sequentially arranged from the distal end toward the proximal end.

[0090] In this embodiment 1, the controllable guiding unit 51 includes an elastic guide member 511 and a control member 512, and the control member 512 is pulled to change the swing angle of the elastic guide member 511; and the elastic guide member 511 also includes a limiting opening 513, and the distal end of the needle tube 3 is arranged in the limiting opening 513.

[0091] In the first embodiment, in a natural state, the elastic guide member 511 remains parallel to the center line of the connecting unit 53 ; when the control member 512 is pulled, the elastic guide member 511 swings toward the proximal end.

[0092] In the first embodiment, the elastic guide 511 and the leading member 6 fix, restrict or clamp the first tissue 1 .

[0093] In the first embodiment, the needle puncture assembly 4 includes a first needle puncture portion 41 and a second needle puncture portion 42 disposed within the first needle puncture portion 41. Figure 10 As shown; when puncturing the first tissue 1, the distal end of the second needle puncture portion 42 exceeds the first needle puncture portion 41, and the second needle puncture portion 42 and the first needle puncture portion 41 pass through the first tissue 1 in sequence.

[0094] In the first embodiment, the hole left by the second needle puncture part 42 and the first needle puncture part 41 sequentially passing through the first tissue 1 is smaller than the hole left by the first needle puncture part 41 directly passing through the first tissue 1 .

[0095] In this embodiment 1, Figure 5 and 6 As shown, the first needle-piercing portion 41 includes a first bend-adjusting tube 411 and a second bend-adjusting tube 412 sleeved in the first bend-adjusting tube 411 and connected to the first bend-adjusting tube 411; the first bend-adjusting tube 411 and the second bend-adjusting tube 412 are bent in a natural state, the first bend-adjusting tube 411 includes a first rib 413 arranged on the small bend side, and the second bend-adjusting tube 412 includes a second rib 415 arranged on the large bend side, as shown in FIG. Figure 7 shown.

[0096] In the first embodiment, the first bend-adjusting tube 411 further includes a first slit 414 disposed opposite to the first rib 413 . The first slit 414 occupies 70% to 90% of the circumference of the first bend-adjusting tube 411 .

[0097] In the first embodiment, the second bend-adjusting tube 412 further includes a second slit 416 disposed opposite to the second rib 415 . The second slit 416 occupies 70% to 90% of the circumference of the second bend-adjusting tube 412 .

[0098] In the first embodiment, the first slit 414 includes a first opening 4141 and a first limiting portion 4142. Figure 7 As shown, in the natural state, one end of the first limiting portion 4142 is in contact with the first opening 4141. Figure 5 As shown, the first limiting portion 4142 can only move in one direction, and thus the first bending adjustment unit 4111 has only one bending direction.

[0099] In the first embodiment, the second needle-piercing portion 42 is pre-installed in the second bending adjustment tube 412 , and the second rib 415 supports the second needle-piercing portion 42 when the second needle-piercing portion 42 reciprocates.

[0100] In the first embodiment, the second needle-piercing portion 42 is pre-installed with a suture 8, which is used to suture the first tissue 1 and the second tissue 2. Figure 13 shown.

[0101] In this embodiment 1, the first bending adjustment tube 411 includes a first bending adjustment unit 4111 and a third bending adjustment unit 4112, the second bending adjustment tube 412 includes a second bending adjustment unit 4121 and a fourth bending adjustment unit 4122, the first rib 413 is located in the first bending adjustment unit 4111, and the second rib 415 is located in the second bending adjustment unit 4121.

[0102] In the first embodiment, the first bending adjustment unit 4111 and the second bending adjustment unit 4121 are naturally bent inward, and the first bending adjustment unit 4111 cannot be bent outward from a vertical state.

[0103] In the first embodiment, the first tissue 1 is a secondary septal tissue, and the second tissue 2 is a primary septal tissue.

[0104] The exemplary operation process of inserting the closure device of the first embodiment is as follows: (1) Establishing a PFO access channel, reserving a guide member 6, ensuring that the distal end of the guide member 6 is in the left atrium, and then pushing the pusher 54 along the guide member 6 through the femoral vein into the right atrium, and then pushing it to the patent foramen ovale position between the secondary septum and the primary septum near the atrial septum; (2) Retract the delivery tube 7 to expose the guide limiting structure 5, pull the control member 512 to swing the elastic guide member 511 toward the right atrium, push the push member 54 to move distally, and limit the secondary septum tissue between the elastic guide member 511 and the guide member 6. At this time, the adaptive support unit 52 also pushes the primary septum to move toward the left atrium, and the support portion 522 supports the primary septum tissue. Figure 8 As shown; (3) The needle tube 3 is moved toward the distal end, and the needle tube 3 is attached to the secondary septum, as shown in FIG. Figure 9 As shown; (4) Operate the second needle puncture part 42 to move its end slightly beyond the first needle puncture part 41, and perform the first puncture. The second needle puncture part 42 and the first needle puncture part 41 pass through the secondary septum in sequence. Figure 10 As shown; (5) Retract the second needle-piercing portion 42 into the first needle-piercing portion 41, push the first needle-piercing portion 41 toward the distal end, and push the second bending tube 412 to bend the first needle-piercing portion 41; (6) The first needle-piercing portion 41 is against the distal end of the primary septum, as shown in FIG. Figure 11 As shown, the second needle-piercing part 42 is operated to perform puncture. Figure 12 As shown, the suture 8 is released, and the suture 8 closes the foramen ovale passage, as shown in FIG. Figure 13 shown. Example 2

[0105] The second embodiment is substantially the same as the first embodiment, except that the adaptive support unit 52 is capable of adaptive deformation.

[0106] In this embodiment, a closing device that facilitates double-tissue acupuncture is introduced, which is used to close the channel between a first tissue 1 and a second tissue 2, including a guide member 6, a needle tube 3, a needle assembly 4 and a guide and limiting structure 5. The guide and limiting structure 5 includes a controllable guiding unit 51, an adaptive supporting unit 52, a connecting unit 53 and a pushing member 54. The controllable guiding unit 51 is connected to the distal end of the needle tube 3, and the controllable guiding unit 51 and the guide member 6 are respectively in contact with the two end faces of the first tissue 1; and the adaptive supporting unit 52 is in contact with the second tissue 2 and deforms according to the shape of the second tissue 2, and the connecting unit 53 provides support force for the adaptive supporting unit 52 when the adaptive supporting unit 52 is in contact with the second tissue 2.

[0107] In the second embodiment, the holding portion 523 includes a sleeve member 526, and the sleeve member 526 is slidably sleeved on the outside of the pushing member 54 along the central axis of the closing device. Figure 14 shown.

[0108] In the second embodiment, the sleeve 526 is operated to reciprocate to change the shape of the adaptive support unit 52 and / or change the distance between the central axis of the closure device and the support portion 522, thereby being able to adapt to primary septal tissues of different sizes, such as Figure 16 shown.

[0109] In the second embodiment, the arc connection portion 521 is connected to the proximal end of the connection unit 53, as shown in FIG. Figure 15 and 17 As shown, such a design facilitates the recovery of the adaptive support unit 52 .

[0110] In this regard, the relevant structure and concept of the second embodiment are similar to those of the first embodiment, and thus will not be described again here. Example 3

[0111] The third embodiment is substantially the same as the second embodiment, except that the preset shapes and supporting fitting forces of different root frames are different, and the guide member further includes a transition structure.

[0112] In this embodiment, a closing device that facilitates double-tissue acupuncture is introduced, which is used to close the channel between a first tissue 1 and a second tissue 2, including a guide member 6, a needle tube 3, a needle assembly 4 and a guide and limiting structure 5. The guide and limiting structure 5 includes a controllable guiding unit 51, an adaptive supporting unit 52, a connecting unit 53 and a pushing member 54. The controllable guiding unit 51 is connected to the distal end of the needle tube 3, and the controllable guiding unit 51 and the guide member 6 are respectively in contact with the two end faces of the first tissue 1; and the adaptive supporting unit 52 is in contact with the second tissue 2 and deforms according to the shape of the second tissue 2, and the connecting unit 53 provides support force for the adaptive supporting unit 52 when the adaptive supporting unit 52 is in contact with the second tissue 2.

[0113] In the third embodiment, the adaptive support unit 52 includes six longitudinally arranged skeletons 527, and the multiple skeletons 527 are separated at the front and rear sides relative to the central axis of the delivery tube 7. The six skeletons 527 form a three-dimensional support surface, such as Figure 18 and Figure 19 shown.

[0114] In the third embodiment, there is a certain distance between adjacent skeletons 527; and the distance between two adjacent skeletons 527 in the middle can facilitate the separation of the needle assembly 4 from the suture piece 8 loaded in the closing device when the needle assembly 4 is withdrawn.

[0115] In this third embodiment, the supporting and fitting forces of the multiple skeletons 527 are different. The skeleton 527 located in the middle is used to fit the middle part of the second tissue 2, and the skeletons 527 located on both sides are used to fit both sides of the second tissue 2; the second tissue 2 is the primary septum tissue.

[0116] In the third embodiment, the flexibility of the skeleton 527 located in the middle is greater than the flexibility of the skeleton 527 located on both sides, and the flexibility of the skeleton 527 gradually increases from the middle to the both sides.

[0117] In the third embodiment, the distance between the skeleton 527 located in the middle and the central axis of the closure device is greater than the distance between the skeletons 527 located on both sides and the central axis of the closure device.

[0118] In the third embodiment, an image-recognizable structure is provided on the frame 527 .

[0119] In the third embodiment, the guide member 6 includes a transition structure 61 . The transition structure 61 is in a rugby-shaped or conical shape. The transition structure is planar or three-dimensional.

[0120] In the third embodiment, when the transition structure 61 reaches the lower edge of the secondary septum tissue, the controllable guiding unit 51 is released to open.

[0121] In this regard, the relevant structure and concept of the third embodiment are similar to those of the second embodiment, and thus will not be described again here.

[0122] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, configurations, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention and all equivalents thereof be defined by the appended claims.

Claims

1. A closing device for facilitating double-tissue acupuncture, used to close a passage between a first tissue and a second tissue, characterized in that: It includes a guide member, a needle-hiding tube, a needle-puncture assembly and a guide and limiting structure, wherein the guide and limiting structure includes a controllable guiding unit, an adaptive supporting unit, a connecting unit and a pushing member, wherein the controllable guiding unit is connected to the distal end portion of the needle-hiding tube, and the controllable guiding unit and the guide member are respectively in contact with the two end surfaces of the first tissue; and the adaptive supporting unit is in contact with the second tissue and deforms in accordance with the shape of the second tissue, and the connecting unit provides supporting force for the adaptive supporting unit when the adaptive supporting unit is in contact with the second tissue.

2. The closure device for facilitating double-tissue acupuncture according to claim 1, characterized in that: The adaptive support unit includes an arc connection portion, a support portion and a retaining portion; and the arc connection portion is connected to the connecting unit, the support portion provides a support area for the second tissue, and the retaining portion is located in the proximal direction of the connecting unit in a natural state.

3. The closure device for facilitating double-tissue acupuncture according to claim 2, characterized in that: The controllable guiding unit and the adaptive supporting unit are located on both sides of the central axis of the closing device; when performing the second puncture, part of the needle assembly abuts against the distal surface of the second tissue, and the supporting part abuts against the proximal surface of the second tissue.

4. The closure device for facilitating double-tissue acupuncture according to claim 2, characterized in that: When the adaptive supporting unit is in contact with the second tissue, the connecting unit and the pushing member provide supporting force for the adaptive supporting unit; and the connecting unit supports the arc-connecting portion, and the pushing member supports the retaining portion.

5. The closure device for facilitating double-tissue acupuncture according to claim 2, characterized in that: The holding portion is a free end of the adaptive supporting unit; and the holding portion further includes an anchoring member, which is adapted to and relatively fixed to the connecting unit.

6. The closure device for facilitating double-tissue acupuncture according to claim 5, characterized in that: It also includes a guide member and a delivery tube, the pushing member enters the target position along the guide member, the needle-hiding tube and the pushing member are pre-installed in the delivery tube; and the retaining portion includes a control locking unit, the distal end of the delivery tube is connected to the control locking unit to stabilize the posture of the adaptive support unit.

7. The closure device for facilitating double-tissue acupuncture according to claim 2, characterized in that: The retaining portion includes a sleeve member that is slidably sleeved outside the pusher along the central axis of the closing device; and the sleeve member is operated to reciprocate to change the shape of the adaptive support unit and / or change the distance between the central axis of the closing device and the support portion.

8. The closure device for facilitating double-tissue acupuncture according to claim 6, characterized in that: The adaptive support unit includes a plurality of longitudinally arranged skeletons, and the plurality of skeletons are located at the front and rear sides relative to the central axis of the conveying pipe, and the plurality of skeletons form a three-dimensional support surface.

9. The closure device for facilitating double-tissue acupuncture according to claim 8, characterized in that: There is a certain distance between adjacent frames; and the distance between two adjacent frames located in the middle can facilitate the separation of the needle assembly from the implant loaded in the closure device when the needle assembly is withdrawn.

10. The closure device for facilitating double-tissue acupuncture according to claim 8, characterized in that: The supporting and fitting forces of the multiple skeletons are different. The skeleton located in the middle is used to fit the middle part of the second tissue, and the skeletons located on both sides are used to fit the two sides of the second tissue; and the flexibility of the skeleton located in the middle is greater than the flexibility of the skeletons located on both sides, and the flexibility of the skeletons gradually increases from the middle to the sides; and the distance between the skeleton located in the middle and the central axis of the closing device is greater than the distance between the skeletons located on both sides and the central axis of the closing device.

11. The closure device for facilitating double-tissue acupuncture according to claim 8, characterized in that: The guide and restriction structure is provided with an image-identifiable structure to facilitate confirmation under imaging conditions that the needle assembly passes through the first tissue or the second tissue along a preset track; and the skeleton is provided with an image-identifiable structure.

12. The closure device for facilitating double-tissue acupuncture according to claim 1, characterized in that: The guide member includes a transition structure, which is in the shape of a rugby ball or a cone, and is planar or three-dimensional; and when the transition structure reaches the lower edge of the first tissue, the controllable guide unit is released to open.

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