CN114533337A

CN114533337A - Rivet-free atrium shunt

Info

Publication number: CN114533337A
Application number: CN202210181655.8A
Authority: CN
Inventors: 高泽明; 姜程文; 熊忠亮; 梁玉晨
Original assignee: Qichen Shanghai Medical Equipment Co ltd; Chenxing Nantong Medical Instrument Co ltd
Current assignee: Qichen Shanghai Medical Equipment Co ltd; Chenxing Nantong Medical Instrument Co ltd
Priority date: 2022-02-25
Filing date: 2022-02-25
Publication date: 2022-05-27
Also published as: WO2023159744A1

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an atrium shunt. A rivetless atrium shunt comprises an atrial septal passage structure, and left atrium wall fixing structures and right atrium wall fixing structures are respectively arranged on two sides of the atrial septal passage structure; the left atrium wall fixing structure, the interatrial septum channel structure and the right atrium wall fixing structure are all woven net structures formed by weaving threads through a weaving process, the rivet-free atrial shunt can automatically expand inside the heart, and the interatrial septum channel of the rivet-free atrial shunt supports a blood flow channel between the left atrium and the right atrium; the rivetless atrium shunt is also provided with a conveyer connecting structure. The atrium shunting device is woven by adopting the weaving wires without rivets, and compared with the traditional atrium shunting device, the atrium shunting device can reduce the damage to a patient and increase the fault-tolerant rate of the operation at the initial use stage of the patient; when the patient condition is improved, the residues in the body can be reduced, and the subsequent damage to the human body is reduced.

Description

Rivet-free atrium shunt

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an atrium shunt.

Background

Heart failure (heart failure) is called heart failure for short, and is the common manifestation of the development of myocardial lesions caused by various reasons. According to current guidelines, heart failure is classified into three categories, namely heart failure HFrEF with reduced ejection fraction, heart failure HFmrEF with median ejection fraction, and heart failure HFpEF with preserved ejection fraction.

To date, HFpEF treatment is almost a blank, except for diuretic therapy to control volume load reduction, control of hypertension and diabetes, and control of atrial fibrillation rhythms.

The existing clinical technique is mainly an atrial shunt woven from nitinol, and in order to deliver and release the atrial shunt, a multi-rivet or single-rivet structure is usually arranged on the atrial shunt, and the atrial shunt is connected with an external delivery device in a riveting manner and delivered to a preset position of a human body through the external delivery device. Therefore, when the condition of a patient is improved, the atrial shunt and the multi-rivet or single-rivet structure of the atrial shunt still have residues in the body of the patient, and certain hidden danger exists for the human body.

Therefore, it is necessary to improve it to overcome the disadvantages in practical applications.

Disclosure of Invention

The invention aims to solve the technical problem that the conventional atrial shunt is provided with a multi-rivet or single-rivet structure and has certain hidden danger to a human body, and aims to provide a rivet-free atrial shunt.

A rivetless atrium shunt comprises an atrial septal passage structure, and left atrium wall fixing structures and right atrium wall fixing structures are respectively arranged on two sides of the atrial septal passage structure;

the left atrium wall fixing structure, the interatrial septum channel structure and the right atrium wall fixing structure are all woven net structures formed by weaving threads through a weaving process, the rivet-free atrial shunt can be expanded in the heart by itself, and the interatrial septum channel of the rivet-free atrial shunt supports a blood flow channel between the left atrium and the right atrium;

the rivet-free atrial shunt is further provided with a conveyor connecting structure.

Preferably, the knitting yarn is made of a polymer material.

Preferably, the braided net structure is a single-layer or multi-layer braided layer.

Preferably, the braided wire is made of a polymer material synthesized by at least one of levorotatory polylactic acid (PLLA), polyglycolic acid (PGA), Polycaprolactone (PCL) or Polydioxanone (PDO).

Preferably, the diameter of the braided wire is 0.08mm-0.15 mm.

Preferably, the left atrial wall fixation structure, the interatrial septum passage structure and the right atrial wall fixation structure are integrally woven by the weaving wire, and then are formed by heat setting.

Preferably, the conveyor connecting structure comprises a hollow cylindrical structure and a bent part which are communicated with each other, and an included angle between the bent part and the hollow cylindrical structure is not more than 90 degrees.

Preferably, the conveyor connecting structure comprises a hollow cylindrical structure and a connecting ring, and the connecting ring is fixedly connected to the hollow cylindrical structure.

Preferably, the connecting mode of the knitting silk and the conveyor connecting structure is pressing or buckling.

Preferably, the distal end of the delivery device connecting structure is a hollow structure, and the distal end of the delivery device connecting structure is connected with the braided wire, so that the delivery device connecting structure is connected with the right atrium wall fixing structure.

Preferably, the conveyor connecting structure is made of a polymer material, and the degradation time required by the conveyor connecting structure is longer than that required by the braided wire.

Preferably, the conveyor connecting structure is a polymer material synthesized by at least one of levorotatory polylactic acid (PLLA), polyglycolic acid (PGA), Polycaprolactone (PCL) or Polydioxanone (PDO).

Preferably, the conveyor connecting structure and/or the braided wire are extruded by a double-wheel extruder and are formed by wire drawing through a wire drawing machine.

Preferably, a pusher is arranged at the proximal end of the conveyor connecting structure, the pusher is provided with a locking sleeve, and the pusher controls the collection and the release of the rivet-free atrial shunt;

when the riveting-free atrial shunt is used, the conveying of the riveting-free atrial shunt is completed through the connection of the bent part and a lasso on a pusher of an outer conveying device;

after the lasso on the pusher is hung on the bent part, rotating the lasso for a preset number of turns until the lasso is stranded on the bent part, and then loading the rivet-free atrial shunt into a loader of an external conveying device for conveying;

after the rivetless atrial shunt is implanted into a human body, the pusher is rotated in the opposite direction to release the noose, thereby removing the external delivery device.

Preferably, a pusher is arranged at the proximal end of the conveyor connecting structure, the pusher is provided with a safety rope, and the pusher controls the collection and the release of the rivet-free atrial shunt;

when in use, the connecting ring is detachably connected with the safety rope on the pusher of the outer conveying device;

after the safety rope on the pusher penetrates through the connecting ring, both ends of the safety rope are detachably fixed on the pusher together, and then the riveting-free atrial shunt is loaded into a loader of an external conveying device for conveying;

after the rivet-free atrial shunt is implanted into a human body, one end of the safety rope is detached from the pusher, and the other end of the safety rope is pulled, so that the safety rope is taken out of the human body.

The positive progress effects of the invention are as follows: the riveting-free atrium shunt is adopted, woven wires are adopted for weaving, and riveting is avoided, so that compared with the traditional atrium shunt device, the injury to a patient can be reduced in the early use stage of the patient, and the fault tolerance rate of an operation is increased; when the patient condition is improved, the residues in the body can be reduced, and the subsequent damage to the human body is reduced.

Drawings

FIG. 1 is a cross-sectional view of one construction of the present invention;

FIG. 2 is a cross-sectional view of the pusher of the present invention;

FIGS. 3-6 are schematic views of the connection to the noose using the bend of FIG. 1;

FIG. 7 is a perspective view of another embodiment of the present invention;

FIG. 8 is a cross-sectional view of one of the structures of FIG. 7;

FIG. 9 is a schematic view of the connection of the safety line using the connection ring of FIG. 8;

fig. 10 to 11 are schematic views of another connection using the connection ring and the safety line of fig. 8.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

Referring to fig. 1-11, a rivetless atrial shunt includes a delivery instrument attachment structure 110, a left atrial wall securement structure 120, an atrial septal channel structure 130, and a right atrial wall securement structure 140.

The left atrial wall fixing structure 120 and the right atrial wall fixing structure 140 are respectively disposed at both sides of the atrial septal passage structure 130, and a connecting passage 150 penetrates through the middle of the left atrial wall fixing structure 120, the middle of the atrial septal passage structure 130, and the middle of the right atrial wall fixing structure 140.

In some embodiments, the left atrial wall fixation structure 120, the interatrial septum passageway structure 130 and the right atrial wall fixation structure 140 are woven mesh structures formed by weaving a woven wire through a weaving process, wherein the woven wire is made of a polymer material.

In some embodiments, the woven mesh structure is a single or multiple woven layers.

In some embodiments, the braided filaments are made of a polymeric material synthesized from at least one of poly-L-lactic acid (PLLA), polyglycolic acid (PGA), Polycaprolactone (PCL), or Polydioxanone (PDO).

In some embodiments, the braided filaments have a diameter of 0.08mm to 0.15 mm.

In some embodiments, the left atrial wall fixation structure 120, the atrial septal access structure 130, and the right atrial wall fixation structure 140 are preferably integrally braided using braided wires, and then heat set.

In some embodiments, the left atrial wall fixation structure 120, the atrial septal access structure 130, and the right atrial wall fixation structure 140 are integrally braided using braided wires and are press-fit connected to the distal end of the transporter attachment structure 110 after being heat set.

In some embodiments, the conveyor connecting structure 110 is attached to the braided wire by a press or a snap.

In some embodiments, the distal end of the delivery device connecting structure 110 is a hollow structure, and the distal end of the delivery device connecting structure 110 is connected with a braided wire, so that the delivery device connecting structure 110 is connected with the right atrium wall fixation structure 140.

In some embodiments, the conveyor connecting structure 110 is made of a polymer material, and the degradation time required for the conveyor connecting structure 110 is longer than the degradation time required for weaving the yarn. Existing conveyor attachment structures are typically of a metallic material and are threaded to threadably engage the conveyor system. The conveyor connecting structure 110 of the invention abandons the traditional structure, adopts the conveyor connecting structure 110 made of high polymer materials, and the degradation speed is not faster than that of the braided wires, so that the problem that the braided wires are scattered because the conveyor connecting structure 110 is degraded first can be avoided.

In some embodiments, the conveyor connecting structure 110 is a polymeric material synthesized using at least one of poly-L-lactic acid (PLLA), polyglycolic acid (PGA), Polycaprolactone (PCL), or Polydioxanone (PDO).

In some embodiments, the conveyor connecting structure 110 and/or the braided wire are extruded through a two-wheel extruder and drawn through a wire drawing machine.

In some embodiments, the proximal end of the transporter connecting structure 110 is detachably connected to an external transportation device, and due to the transporter connecting structure 110 used in the present invention, the transporter connecting structure 110 cannot be screwed to the external transportation device, which is a rivetless connection compared to the prior art. When the invention is detachably connected with an external conveying device, the invention is realized by adopting different structures as follows.

In some embodiments, referring to fig. 1, the conveyor connecting structure 110 includes a hollow cylindrical structure 111 and a bent portion 112 communicating with each other, and the bent portion 112 forms an angle of not more than 90 ° with the hollow cylindrical structure 111.

In some embodiments, referring to FIG. 2, pusher 210 is provided at the proximal end of delivery instrument attachment structure 110, pusher 210 having a locking collar 220, pusher 210 controlling the deployment and deployment of the rivetless atrial shunt of the present invention; the folding portion 112 may be removably coupled to a noose 220 on the pusher 210. The design of the bending portion 112 of the present invention not only allows the noose 220 on the pusher 210 to catch when the present invention is loaded, but also allows the noose 220 to be easily released and removed when the present invention needs to be released.

Referring to fig. 3-6, in use, the delivery of the rivetless atrial shunt is completed by the connection of the bending portion 112 and the noose 220 on the pusher 210; after the noose 220 on the pusher 210 is hung on the bend 112, the noose 220 is rotated a predetermined number of turns until the noose 220 is twisted about the bend 112, as shown in fig. 6, and the rivetless atrial shunt is loaded into the loader 230 of the external delivery device for delivery. After implantation of the rivetless atrial shunt into the body, the pusher 210 is rotated in the opposite direction to release the noose 220 and the external delivery device is removed.

In some embodiments, referring to fig. 7 and 8, the transporter connection structure 110 includes a hollow cylindrical structure 111 and a connection ring 113 in communication with each other.

Referring to FIGS. 9-11, pusher 210 is provided at the proximal end of transporter attachment structure 110, pusher 210 having safety cord 240, pusher 210 controlling the deployment and deployment of the rivetless atrial shunt of the present invention; in use, the attachment ring 113 may be removably attached to the safety cord 240 on the pusher 210. After the safety rope 240 on the pusher 210 passes through the connection ring 113, both ends of the safety rope 240 are detachably fixed on the pusher 210 together, and then the rivetless atrial shunt is loaded into the loader 230 of the external delivery device for delivery; after implantation of the rivetless atrial shunt into the body, one end of the safety cord 240 is detached from the pusher 210 and the other end of the safety cord 240 is pulled, thereby removing the safety cord 240 from the body.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. A rivetless atrium shunt comprises an atrial septal passage structure, and left atrium wall fixing structures and right atrium wall fixing structures are respectively arranged on two sides of the atrial septal passage structure;

the riveting-free atrial shunt is characterized in that the left atrial wall fixing structure, the interatrial septum channel structure and the right atrial wall fixing structure are all woven mesh structures formed by weaving threads through a weaving process, the riveting-free atrial shunt can be self-expanded inside the heart, and the interatrial septum channel of the riveting-free atrial shunt supports a blood flow channel between the left atrium and the right atrium;

2. The rivetless atrial shunt of claim 1, wherein the delivery mechanism comprises a hollow cylindrical structure and a bend in communication with each other, the bend forming an angle of no more than 90 ° with the hollow cylindrical structure.

3. The rivetless atrial shunt of claim 1, wherein the delivery mechanism comprises a hollow cylindrical structure and a connecting ring in communication with each other, the connecting ring being fixedly attached to the hollow cylindrical structure.

4. The rivetless atrial shunt of any one of claims 2 through 3, wherein the braided wire of the rivetless atrial shunt is attached to the transporter attachment structure by a press fit or a snap fit.

5. The rivetless atrial shunt of claim 4, wherein a distal end of said transporter attachment structure is a hollow structure, said transporter attachment structure distal end engaging said braided wire such that said transporter attachment structure is attached to said right atrial wall fixation structure.

6. The rivetless atrial shunt of claim 1, wherein the woven mesh structure is a single or multiple braided layers.

7. The rivetless atrial shunt of claim 1, wherein the braided wire has a diameter of 0.08mm to 0.15 mm.

8. The rivetless atrial shunt of claim 1, wherein the transporter attachment structure is made of a polymeric material, wherein the transporter attachment structure requires a degradation time that is longer than a degradation time required for the braided wire;

the conveyer connecting structure is made of a high polymer material synthesized by at least one of levorotatory polylactic acid, polyglycolic acid, polycaprolactone or polydioxanone.

9. The rivetless atrial shunt of claim 2, wherein a pusher is provided at a proximal end of the delivery mechanism, the pusher having a locking collar, the pusher controlling the capturing and releasing of the rivetless atrial shunt;

when the atrium shunt is used, the atrium shunt is conveyed by connecting the bent part with a lasso on a pusher of an outer conveying device;

10. The rivetless atrial shunt of claim 3, wherein the proximal end of the delivery device attachment structure has a pusher with a safety cord, the pusher controlling the capturing and releasing of the rivetless atrial shunt;