CN211583282U

CN211583282U - Absorbable occluder and occlusion system

Info

Publication number: CN211583282U
Application number: CN201921589085.6U
Authority: CN
Inventors: 张智伟; 付明娟
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2019-09-20
Filing date: 2019-09-20
Publication date: 2020-09-29
Anticipated expiration: 2029-09-20

Abstract

The utility model relates to an can absorb plugging device and plugging system, can absorb plugging device includes the rack, the rack includes first net dish, the second net dish, tie head and head, the distal end of first net dish links to each other with the near-end of second net dish, the free end of first net dish links to each other with tie head, the free end of second net dish links to each other with the head, the rack is formed with one and accepts the chamber, when the plugging device is in the expansion state, the near-end of first net dish is formed with first quotation, the distal end of second net dish is formed with the second quotation, tie head and head all accept in accepting the intracavity, tie the head is located between first quotation and the second quotation, the head is located between first quotation and the second quotation. The utility model discloses an absorbable occluder can avoid producing the thrombus in tieing head and head department.

Description

Absorbable occluder and occlusion system

Technical Field

The utility model relates to the field of medical equipment, especially, relate to an can absorb occluder and shutoff system.

Background

With the continuous development of interventional materials and interventional cardiology, minimally invasive treatment of congenital heart diseases such as atrial septal defects (VSD), ventricular septal defects (ASD) and Patent Ductus Arteriosus (PDA) through a catheter interventional occluder becomes an important method.

Referring to fig. 1, the current occluder 100 used at home and abroad includes a net frame 110, and the net frame 110 is woven by metal braided wires (e.g. nitinol wires). The net frame 110 comprises a plug 111 and a sealing head 112, and the proximal ends of the metal braided wires of the net frame 110 are converged at the plug 111, that is, the proximal ends of the metal braided wires of the net frame 110 are fixedly connected to the plug 111. The distal ends of the woven wires of the frame 110 converge on the head 112, i.e., the distal ends of the woven wires of the frame 110 are fixedly connected to the head 112. The metal braided wire is connected with a plug 111 and a seal head 112 and then placed in a mould for heat setting, the net frame 110 after heat setting is provided with a first blocking disc 113, a second blocking disc 114 and a waist 115, the plug 111 protrudes to the near end side on the near end face of the first blocking disc 113, and the seal head 112 protrudes to the far end side on the far end face of the second blocking disc 114. In this way, after the occluding device 100 is implanted, thrombus is easily generated at the plug head 111 and the sealing head 112.

SUMMERY OF THE UTILITY MODEL

Based on this, it is necessary to provide an absorbable occluder to solve the problem that thrombus is easily generated at the head and the sealing head after the occluder is implanted in the prior art.

The utility model provides an absorbable plugging device, including the rack, the rack includes first net dish, the second net dish, tie head and head, the distal end of first net dish links to each other with the near-end of second net dish, the free end of first net dish links to each other with the tie head, the free end of second net dish links to each other with the head, the rack is formed with one and accepts the chamber, when the plugging device is in the expansion state, the proximal end of first net dish is formed with first quotation, the distal end of second net dish is formed with the second quotation, tie head and head all accept in accepting the intracavity, tie head is located between first quotation and the second quotation, the head is located between first quotation and the second quotation.

In one embodiment, the plug is provided with a through hole, the through hole penetrates through the near end of the plug and the far end of the plug, the plugging device further comprises a locking structure, the locking structure is located in the accommodating cavity and comprises a locking piece and an elastic chuck, the far end of the locking piece is connected with the end enclosure, the near end of the locking piece is freely suspended, the elastic chuck is arranged on the near end of the locking piece, the width of the elastic chuck is larger than the aperture of the through hole, the elastic chuck can radially contract under the action of external force to pass through the through hole, the elastic chuck recovers to the size larger than the aperture of the through hole after passing through the through hole, and the elastic chuck can abut against the end face of the near end of.

In one embodiment, the locking structure further comprises a limiting arm, the limiting arm is arranged on the locking piece and extends along the radial direction of the locking piece, and the distance from the free end of the limiting arm to the locking piece is larger than the gap between the locking piece and the through hole.

In one embodiment, the proximal end of the locking element is provided with a threaded hole.

In one embodiment, the proximal end of the first mesh disk is further provided with an inlet hole and an outlet hole, and the inlet hole and the outlet hole are symmetrical about the geometric center line of the absorbable occluder.

In one embodiment, the absorbable occluder further comprises a first flow-blocking membrane connected to the first mesh disc in the containing cavity, and a second flow-blocking membrane connected to the second mesh disc in the containing cavity.

In one embodiment, the net rack further comprises a waist part, the first net disk is connected with the second net disk through the waist part, the diameter of the waist part is smaller than that of the first net disk, and the diameter of the waist part is smaller than that of the second net disk.

In one embodiment, the absorbable occluder further comprises a third flow-blocking membrane connected to the waist in the containing cavity.

In one embodiment, there is also provided a plugging system comprising a delivery device and the above-described resorbable plugging device, the delivery device being releasably connectable to the resorbable plugging device.

In one embodiment, the conveyer further comprises a locking tube, a bolt and a connecting wire, the bolt is arranged in a tube cavity of the locking tube, the bolt can slide along the central axis of the locking tube, one end of the connecting wire is connected with the locking tube, and the other end of the connecting wire returns to the side hole after passing through the first net disc to be connected with the bolt.

When foretell absorbable plugging device is in the expansion state, second net disk near-end is formed with the second quotation, the tiehead is located between first quotation and the second quotation, can avoid tiehead protrusion in the near-end side of first quotation, and then avoid producing the thrombus in tiehead department, and can avoid the tiehead to collude the valve, thereby the chordae tendinae damages cardiac tissue, the head is located between first quotation and the second quotation, can avoid producing the thrombus in head department, and can avoid the head to collude the valve, thereby the chordae tendinae damages cardiac tissue.

Drawings

Fig. 1 is a schematic structural diagram of an occluder in the prior art.

Figure 2 is a schematic structural view of an absorbable occluding device in one embodiment.

Fig. 3 is a schematic structural view of a rack in an embodiment.

Fig. 4 is a schematic structural diagram of a locking structure in an embodiment.

Figure 5 is a diagram of the attachment of the delivery device to the resorbable occluder in one embodiment.

Figure 6 is a diagram illustrating the transport of the transporter and the absorbable occluding device in one embodiment.

Figure 7 is a diagram illustrating the release of the delivery device and the absorbable closure device, in one embodiment.

Detailed Description

In order to make the above objects, features and advantages of the present invention more comprehensible, embodiments of the present invention are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention can be embodied in many different forms other than those specifically described herein, and it will be apparent to those skilled in the art that similar modifications can be made without departing from the spirit and scope of the invention, and it is therefore not to be limited to the specific embodiments disclosed below.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

For purposes of more clearly describing the structure of the present application, the terms "distal" and "proximal" are used as terms of orientation, wherein "distal" refers to the end of the surgical procedure distal from the operator and "proximal" refers to the end of the surgical procedure proximal to the operator.

Referring to fig. 2, the present embodiment provides an absorbable occluder 200, which comprises a net frame 210, a first flow-blocking membrane 221, a second flow-blocking membrane 222 and a third flow-blocking membrane 223, wherein the first flow-blocking membrane 221, the second flow-blocking membrane 222 and the third flow-blocking membrane 223 are all connected to the net frame 210.

The net frame 210 comprises a first net disk 211, a second net disk 212, a waist 213, a bolt head 214 and a seal head 215, the waist 213 is positioned between the first net disk 211 and the second net disk 212, the far end of the first net disk 211 is connected with the near end of the second net disk 212 through the waist 213, the first net disk 211, the second net disk 212 and the waist 213 are all formed by weaving braided wires and then heat setting, the first net disk 211, the second net disk 212 and the waist 213 form an integrated structure together, the braided wires are made of degradable materials, after the absorbable occluder 200 is implanted into a body, after a certain time of degradation reaction, the integrated structure can be completely degraded, compared with the existing metal occluder, adverse reaction caused by metal foreign matters left in the body can be prevented. Preferably, the material of the braided filaments is polylactic acid.

The free end of the first mesh disk 211 is connected to the plug 214, that is, the proximal end of the first mesh disk 211 is connected to the plug 214, which can prevent the braided wires of the first mesh disk 211 from loosening during the delivery and implantation processes, and further prevent the absorbable blocking device 200 from being damaged. When the absorbable occluding device 200 is in a deployed state, a first disc surface P is formed at the proximal end of the first mesh disc 211. It is understood that the absorbable occluding device 200 can perform the occluding function after being implanted in the human body, and the state of the absorbable occluding device 200 when not degraded is equivalent to the state of being unfolded.

The free end of the second mesh plate 212 is connected with the sealing head 215, that is, the distal end of the second mesh plate 212 is connected with the sealing head 215, so that the braided wires of the second mesh plate 212 can be prevented from loosening in the conveying and implanting processes, and the absorbable blocking device 200 can be prevented from being damaged. When the absorbable occluding device 200 is in the deployed state, a second disc surface Q is formed at the proximal end of the second mesh disc 212. The plug 214 is located between the first disk surface P and the second disk surface Q, so that the plug 214 can be prevented from protruding out of the proximal end side of the first disk surface P, and further thrombus can be prevented from being generated at the plug 214, and the plug 214 can be prevented from hooking the valve and the chordae tendinae, thereby damaging the heart tissue. The seal head 215 is located between the first disk surface P and the second disk surface Q, so that thrombus can be prevented from being generated at the seal head 215, and the seal head 215 can be prevented from hooking valves and chordae tendineae to damage heart tissues.

The diameter of the waist 213 is smaller than that of the first mesh disc 211, the diameter of the waist 213 is smaller than that of the second mesh disc 212, and the waist 213 is attached to the tissue of the defect after the absorbable occluding device 200 is implanted.

The integral structure is connected with the plug 214 and the sealing head 215, so that the net rack 210 forms a containing cavity 216, and the plug 214 is contained in the containing cavity 216, thereby avoiding thrombus at the plug 214 after the absorbable occluding device 200 is implanted. In contrast, even if a thrombus is generated at the plug head 214 and the thrombus is detached therefrom, the thrombus can only fall into the accommodation chamber 216 of the rack 210 because the plug head 214 is accommodated in the accommodation chamber 216, and the thrombus cannot move out of the accommodation chamber 216 with the blood flow because of the blocking action of the rack 210. Meanwhile, the plug head 214 is accommodated in the accommodating cavity 216 to facilitate endothelial coating, and finally the thrombus can be attached to the net rack 210 and then endothelialized without causing danger to the patient.

The sealing head 215 is accommodated in the accommodating cavity 216, so that thrombus generated after the absorbable occluding device 200 is implanted can be avoided, and meanwhile, endothelial climbing is facilitated. Further, even if a thrombus is generated at the seal 215, it does not pose a risk to the patient.

The first flow blocking film 221, the second flow blocking film 222 and the third flow blocking film 223 are all located in the containing cavity 216, the first flow blocking film 221 is connected with the first net disc 211, the second flow blocking film 222 is connected with the second net disc 212, the third flow blocking film 223 is connected with the waist 213, the first flow blocking film 221, the second flow blocking film 222 and the third flow blocking film 223 can play a role in blocking, thrombus can be deposited on the first flow blocking film 221, the second flow blocking film 222 and the third flow blocking film 223, and endothelialization is accelerated.

Referring to fig. 2 and 3 together, the proximal end of the first mesh disk 211 is further provided with a pass-in hole 2111 and a pass-out hole 2112, the pass-in hole 2111 and the pass-out hole 2112 being symmetrical with respect to the geometric centerline 231 of the absorbable occluding device 200.

The plug 214 is made of degradable material, and after the absorbable occluding device 200 is implanted for a certain time, the plug 214 can be degraded and can not be left in the human body as a metal foreign body. The plug 214 is a ring structure, and a through hole 2141 is formed in the plug 214, and the through hole 2141 penetrates through the proximal end of the plug 214 and the distal end of the plug 214.

Referring to fig. 2 and 4, the absorbable closure device 200 further comprises a locking structure 240, the locking structure 240 is located in the receiving cavity 216, the locking structure 240 comprises a locking member 241, a resilient clip 242 and a retaining arm 243, the resilient clip 242 is connected to the locking member 241, and the retaining arm 243 is disposed on the locking member 241.

Referring to fig. 4, the locking element 241 is made of degradable material, and after the absorbable closure device 200 is implanted for a certain period of time, the locking element 241 can be degraded and will not remain in the human body as a metal foreign body. The distal end of the locking element 241 is attached to the closure head 215 and the proximal end of the locking element 241 is free to float. Under the action of external force, the proximal end of the locking element 241 can pass through the through hole 2141, and in the process, the distal end of the locking element 241 drives the sealing head 215 to approach the plug head 214, so that the absorbable occluding device 200 is gradually deformed into a deployed state.

The distance from the free end of the limiting arm 243 to the locking piece 241 is greater than the gap between the locking piece 241 and the through hole 2141, when the absorbable blocking device 200 is implanted, the locking piece 241 drives the sealing head 215 to approach the plug 214 under the action of external force, so that the absorbable blocking device 200 is expanded, the limiting arm 243 is in limiting fit with the far end of the plug 214, the locking piece 241 can be prevented from driving the sealing head 215 to excessively approach the plug 214, the condition that the expanded form of the absorbable blocking device 200 cannot be attached to tissues of defects such as atrial septal septa.

The elastic clip 242 is disposed on the proximal end of the locking element 241, the width L of the elastic clip 242 is greater than the aperture of the through hole 2141, the elastic clip 242 can be radially contracted by external force to pass through the through hole 2141, the elastic clip 242 returns to a size greater than the aperture of the through hole 2141 after passing through the through hole 2141, and the elastic clip 242 can abut against the proximal end face of the plug 214 after returning to a size greater than the aperture of the through hole 2141. When the occluder is implanted, the atrial septum exerts acting force on the absorbable occluder 200, so that the sealing head 215 has a movement tendency far away from the plug 214, the elastic clamping head 242 is abutted against the proximal end face of the plug 214, the locking piece 241 of the absorbable occluder 200 can be prevented from returning along the original path, the implanted absorbable occluder 100 is kept in an unfolded state, and the use requirement of closing and occluding defects is met.

Specifically, the locking element 241 is a rod-shaped structure and includes a first connecting portion 2411 and a second connecting portion 2412 connected to each other, a distal end of the first connecting portion 2411 is connected to a proximal end of the second connecting portion 2412 and the limiting arm 243, a proximal end of the first connecting portion 2411 is freely suspended and is a free end of the locking element 241, a threaded hole 2412 is formed in the proximal end of the first connecting portion 2411, and a distal end of the second connecting portion 2412 is connected to the sealing head 215. The resilient clip 242 is disposed on an outer wall of the proximal end of the first connection portion 2411.

Referring to fig. 5 and 6, an embodiment of the present invention further provides a plugging system 400, which comprises a conveyor 300 and the absorbable occluder 200, wherein the conveyor 300 is detachably connected to the absorbable occluder 200, and after the absorbable occluder 200 is delivered into the human body, the conveyor 300 is detached from the absorbable occluder 200, so as to withdraw the conveyor 300 from the human body and leave the absorbable occluder 200 in the human body to plug the defect.

Carrier 300 includes sheath 311 (sheath 311 is shown in fig. 6), locking tube 312, locking head 313, latch 314, and connecting wire 315. Sheath 311 is a hollow structure for establishing a delivery channel from outside the body to inside the body, such that the absorbable occluding device 200 can be delivered to the defect along sheath 311.

Locking tube 312 is insertable into sheath 311, and locking tube 312 is movable in sheath 311 in the axial direction of sheath 311, locking tube 312 being a hollow structure having lumen 3121.

The locking head 313 is connected with the distal end of the locking tube 312, an axial hole 3131 and a side hole 3132 are arranged on the locking head 313, the axial hole 3131 is formed in the axial direction of the locking head 313, the axial hole 3131 is communicated with the tube cavity 3121 of the locking tube 312, and the forming direction of the side hole 3132 is arranged at a right angle to the axial hole 3131.

The latch 314 is a rod-shaped structure, the width of the latch 314 is smaller than the size of the lumen 3121 of the locking tube 312, and the width of the latch 314 is also smaller than the aperture of the axial hole 3131 and the side hole 3132 of the locking head 313. It is understood that the width of the plug 314 means a cross section obtained by cutting the plug 314 in the direction perpendicular to the axial direction of the plug 314, and the distance between two points of the cross section, which are farthest from the straight line, is the width of the plug 314. The size of the lumen 3121 refers to the inner diameter of the locking tube 312. The latch 314 is disposed in the lumen 3121 of the locking tube 312, the latch 314 is slidable along the lumen 3121 of the locking tube 312, and a distal end of the latch 314 is extendable from the axial hole 3131 of the locking head 313. The distal end of the latch 314 is provided with external threads (not shown) that mate with a threaded bore 2412 at the proximal end of the first connection portion 2411.

The connecting wire 315 is a filament with two free ends, the connecting wire 315 is folded to form a folded portion 3151 at the folded portion, the two free ends of the connecting wire 315 are fixed on the inner wall of the locking tube 312, the remaining portion extends along the lumen 3121 of the locking tube 312, and the folded portion 3151 is penetrated through the side hole 3132 of the locking head 313.

When the delivery device 300 is connected to the absorbable occluding device 200, the other end of the connecting wire 315 passes through the first mesh panel 211 and then returns to the side hole 3132 to be connected to the plug 314. Specifically, the folding portion 3151 is inserted through the through hole 2111 of the first mesh disk 211 and through the through hole 2112 of the first mesh disk 211, then the folding portion 3151 returns to the side hole 3132, and the distal end of the latch 314 is inserted through the folding portion 3151 and the axial hole 3131 of the locking head 313 in sequence from the lumen 3121 of the locking tube 312, so that the delivery device 300 is releasably connected to the absorbable occluding device 200. When release is desired, the distal end of the latch 314 is withdrawn into the lumen 3121 of the locking tube 312 to release the delivery device 300 from the absorbable occluding device 200.

The distal end of the latch 314 extends out of the axial hole 3131 and then enters the receiving cavity 216 through the through hole 2141, the external thread of the latch 314 is connected with the threaded hole 2412, and the latch 314 moves axially along the locking tube 312, so that the shape of the absorbable occluder 200 can be changed. Before the absorbable occluding device 200 is installed in the sheath 311, the plug 314 drives the sealing head 215 away from the plug 214 to reduce the diameter of the net rack 210 for installation in the sheath 311. The absorbable occluding device 200 is conveyed to the defect along the sheath 311 and then moves out of the sheath 311, the bolt 314 drives the distal end of the locking piece 241 and the elastic chuck 242 to pass through the through hole 2141, and the movable elastic chuck 242 abuts against the proximal end of the bolt head 214 after passing through the through hole 2141, so that the occluding device can keep an unfolded state. In the process of unfolding the absorbable occluding device 200, the limiting arm 243 is in limiting fit with the plug 214, so that the plug 215 can be prevented from being excessively close to the plug 214, and the absorbable occluding device 200 cannot be attached to the atrial septum.

Referring to fig. 7, after the absorbable occluding device 200 is attached to the atrial septum, the distal end of the latch 314 is disengaged from the distal threads of the locking member 241, the latch 314 is withdrawn into the lumen 3121 of the locking tube 312 to disengage the fold 3151 of the connecting wire 315, and the fold 3151 is pulled out of the exit hole 2112 and the entry hole 2111 through the locking tube 312 in sequence, so that the delivery device 300 is disengaged from the absorbable occluding device 200 for subsequent complete withdrawal of the delivery device 300 from the body.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. The utility model provides an absorbable plugging device, includes the rack, its characterized in that, the rack includes first net dish, second net dish, tieing head and head, the distal end of first net dish with the near-end of second net dish links to each other, the free end of first net dish with the tieing head links to each other, the free end of second net dish with the head links to each other, the rack is formed with one and accepts the chamber, when the plugging device is in the expansion state, the proximal end of first net dish is formed with first quotation, the distal end of second net dish is formed with the second quotation, the tieing head with the head all accept in accept the intracavity, the tieing head is located first quotation with between the second quotation, the head is located first quotation with between the second quotation.

2. The absorbable occluder of claim 1, wherein said plug has a through-hole, the through hole penetrates through the proximal end of the plug head and the distal end of the plug head, the occluder further comprises a locking structure, the locking structure is positioned in the accommodating cavity and comprises a locking piece and an elastic chuck, the far end of the locking piece is connected with the end enclosure, the near end of the locking piece is freely suspended, the elastic chuck is arranged on the near end of the locking piece, the width of the elastic clamping head is larger than the aperture of the through hole, the elastic clamping head can be radially contracted under the action of external force to pass through the through hole, the elastic clamping head is restored to be larger than the size of the aperture of the through hole after passing through the through hole, and the elastic clamping head can be abutted against the proximal end face of the plug head after being restored to be larger than the size of the aperture of the through hole.

3. The absorbable occluder of claim 2, wherein said locking structure further comprises a stop arm disposed on said locking member, the distance from the free end of said stop arm to said locking member being greater than the gap between said locking member and said through-hole.

4. The absorbable occluder of claim 3, wherein the proximal end of said locking element is provided with a threaded hole.

5. The absorbable occluder of claim 1, wherein the proximal end of said first mesh disk further comprises an access hole and an exit hole, said access hole and said exit hole being symmetrical about the geometric centerline of said absorbable occluder.

6. The absorbable occluder of claim 1, further comprising a first flow-blocking membrane attached to said first mesh disc within said containment chamber, a second flow-blocking membrane attached to said second mesh disc within said containment chamber.

7. The absorbable occluder of claim 6, wherein said net mount further comprises a waist, said first net disk being connected to said second net disk by said waist, said waist having a diameter less than the diameter of said first net disk, said waist having a diameter less than the diameter of said second net disk.

8. The absorbable occluder of claim 7, further comprising a third flow-blocking membrane attached to said waist within said containment chamber.

9. A occlusion system comprising a delivery device and an absorbable occluder of any one of claims 1 to 8, the delivery device being releasably connectable to the absorbable occluder.

10. The occlusion system of claim 9, wherein the delivery device further comprises a locking tube, a latch disposed within a lumen of the locking tube, the latch being slidable along a central axis of the locking tube, and a connecting wire having one end connected to the locking tube and another end connected to the latch through the first mesh panel and back to the side aperture.