CN113749699A - Atrial shunt delivery device and delivery method - Google Patents

Abstract

The application relates to the technical field of medical equipment, provides an atrium shunt conveyor and conveying method, and wherein atrium shunt conveyor includes: the fixed pressure pipe is provided with an installation channel; the atrial shunt is arranged outside the fixed pressure pipe; the puncture mechanism comprises a puncture rod arranged in the installation channel and a puncture piece connected with the puncture rod, and the puncture piece is arranged at one end of the fixed pressure pipe and is positioned outside the fixed pressure pipe; wherein, be equipped with the installation clearance between puncture piece and the fixed pipe of pressing, atrium shunt conveyor locates in the installation clearance partially. Through the technical scheme of this application, can improve atrium shunt's implantation efficiency, reduce transportation apparatus number of times, practice thrift operation time, reduce the operation risk.

Description

Atrial shunt delivery device and delivery method

Technical Field

The application relates to the technical field of medical equipment, in particular to an atrial shunt conveying device and an atrial shunt conveying method.

Background

Interatrial septum ostomy is a method of treating heart disease. The left atrium and the right atrium are communicated by establishing a channel between the interatrial septum of the patient, and when the heart contracts, blood in the left atrium can be shunted to the right atrium through the channel, so that the heart load is relieved. In the related art, when the atrial shunt is implanted, instruments need to be conveyed in the conveying system for multiple times, the problems of long time of the atrial shunt implantation process and complicated conveying process exist, and the operation risk is higher.

Disclosure of Invention

An object of the embodiment of the present application is to provide an atrial shunt delivery apparatus for improving implantation efficiency of an atrial shunt, saving operation time and reducing operation risk.

An embodiment of a first aspect of the present application provides an atrial shunt delivery device, comprising: the fixed pressure pipe is provided with an installation channel; the atrium shunt is arranged outside the fixed pressing pipe; the puncture mechanism comprises a puncture rod arranged in the installation channel and a puncture piece connected with the puncture rod, and the puncture piece is arranged at one end of the fixed pressure pipe and is positioned outside the fixed pressure pipe; wherein, be equipped with the installation clearance between puncture piece and the fixed pressure pipe, atrium shunt conveyor part is located in the installation clearance.

In the above implementation, the atrial shunt delivery device includes a fixed pressure tube, an atrial shunt, and a puncture mechanism. Wherein, the fixed pressure pipe is provided with an installation channel. The puncture rod of puncture mechanism locates in the fixed pressure pipe, and the puncture piece is located the one end of fixed pressure pipe to link to each other with the puncture rod, and puncture rod and fixed pressure pipe between be equipped with the installation clearance that is used for fixed atrium shunt. The atrial shunt is arranged on the periphery of the fixed pressure pipe and is locally fixed in a mounting gap defined between the puncture piece and the fixed pressure pipe so as to prevent falling off in the conveying process. Specifically, when carrying the atrium shunt, the first room interval puncture that carries out of puncture piece of accessible self, need not to carry the puncture sheath and accomplish the atrium interval puncture, the puncture can use the expander to expand the puncture hole after finishing, continue the propelling movement after finishing the expansion, carry to the atrium interval until the interface channel of atrium shunt, owing to alright realize the atrium interval puncture operation in transportation process, reduced the number of times of transporting the apparatus among the operation process, thereby shortened operation time, reduced the risk of operation.

In a possible implementation manner, the fixed pressure pipe faces the inner wall face of one end of the puncture piece, an internal thread is arranged, the puncture rod is provided with an external thread, the fixed pressure pipe is in threaded connection with the puncture rod, and the installation gap for fixing the atrium shunt is defined between the puncture pieces.

In the implementation process, the inner thread is arranged on the inner wall surface of one end, facing the puncture piece, of the fixed pressing pipe, the outer thread is arranged on one end, connected with the puncture piece, of the puncture rod, when the atrium shunt is fixed, the local part of the atrium shunt can be arranged in the installation gap between the fixed pressing pipe and the puncture piece, then the atrium shunt is locally pressed in the installation gap in a mode of screwing the fixed pressing pipe and the puncture rod, the risk that the atrium shunt falls off in the conveying process is prevented, and therefore the efficiency of conveying the atrium shunt is further improved.

In one possible implementation, the piercing element comprises a piercing portion, and the diameter of the piercing portion gradually decreases in a direction away from the fixed pressure tube.

In the above-mentioned realization process, the puncture piece includes puncture portion, and the diameter of puncture portion is reduced gradually by the one end that links to each other with the puncture rod to the other end, and puncture portion is the toper promptly, is convenient for puncture operation, and can realize continuing to carry the atrium shunt after the puncture.

In a possible implementation manner, the puncture element further comprises an expansion part, and the expansion part is in arc transition connection with one end of the puncture part close to the fixed pressure pipe and extends to the outside of the fixed pressure pipe.

In the above-mentioned realization process, the puncture piece still includes the expansion portion that adopts circular arc transitional coupling with the one end that puncture portion and puncture rod link to each other, and the expansion portion is the tubular structure, and extends to the outside that is located fixed pressure pipe for expand the stoma after the puncture operation, so that atrium shunt implants in the interatrial interval, and owing to need not to carry the expansion device after the puncture, therefore the operation time further reduces, can further reduce the operation risk. Meanwhile, the size of the stoma is matched with the size of the atrium shunt after the stoma is expanded, so that the accuracy of the stoma size is improved.

In one possible implementation, the atrial shunt includes a left disc and a right disc connected to the left disc, and a connection channel is defined between the left disc and the right disc, and the fixed pressure tube is located in the connection channel.

In the above implementation process, the atrial shunt includes a left disc and a right disc, a connection channel is defined between the left disc and the right disc, the connection channel is configured at the interatrial septum and is used for allowing blood to flow from the left atrium to the right atrium, and the left disc and the right disc are respectively configured at the left atrium and the right atrium and are clamped at two sides of the stoma to play a role in fixing so as to prevent the stoma from closing.

In one possible implementation manner, the method further includes: and the conveying catheter is sleeved outside the fixed pressing pipe and the atrial shunt and used for pressing the atrial shunt.

In the implementation process, the atrium shunt conveying device further comprises a conveying catheter sleeved outside the fixed pressure pipe and the atrium shunt, and the conveying catheter can tightly press the atrium shunt between the conveying catheter and the fixed pressure pipe so as to improve the safety of the atrium shunt in the conveying process.

In one possible implementation, the inner wall surface of the connecting channel is coated with a first coating for reducing the blood flow resistance; and/or, the outer surface of the atrial shunt is coated with a second coating for inhibiting endothelialization.

In the implementation process, the inner wall surface of the connecting channel is coated with the first coating film, the first coating film can be made of polytetrafluoroethylene and can also be a microporous film formed by pressing polytetrafluoroethylene and fabric, and the inner wall surface of the connecting channel can be smoother by the first coating film so as to reduce blood resistance and thrombus risk.

The second coating is coated on the outer surface of the atrial shunt, and the second coating is a drug coating, such as rapamycin, paclitaxel and other drug coatings, so that endothelialization of the device is inhibited, and the stoma is prevented from being closed.

In one possible implementation, the left disc and the right disc are both elastic members.

In the implementation process, the left disc and the right disc are elastic pieces, so that the left disc and the right disc can be compressed and deformed in the conveying process conveniently, conveying is facilitated, elastic potential energy can be released after implantation, and the original shape is restored to play a role in fixing and clamping the stoma and preventing the stoma from being closed.

In a possible implementation manner, the left disc and the right disc are integrally woven through at least one weaving net; or the left disc and the right disc are respectively woven by at least one woven mesh and are formed by laser welding.

In accordance with a second aspect of the present invention, there is provided an atrial shunt delivery method, adapted for use with the atrial shunt delivery device of any one of the first aspect, comprising: sleeving a fixed pressure pipe outside the puncture rod, and defining an installation gap between one end of the fixed pressure pipe and the puncture piece;

the atrium shunt is partially arranged in the installation gap and is tightly pressed in a mode of threaded connection of the puncture rod and the fixed pressure pipe;

performing atrial septal puncture of the heart by the puncture piece, and expanding the puncture hole by the expansion part of the puncture piece;

delivering the connecting channel of the atrial shunt to the interatrial septum stoma and deploying the left and right discs of the atrial shunt to the left and right atria, respectively;

and releasing the fixation of the fixed pressure pipe and the puncture piece on the atrial shunt, and respectively clamping the two sides of the interatrial septum stoma by the left disc and the right disc of the atrial shunt.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments of the present application will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and that those skilled in the art can also obtain other related drawings based on the drawings without inventive efforts.

FIG. 1 is a schematic cross-sectional view of an atrial shunt delivery device according to an embodiment of the present application;

FIG. 2 is a schematic cross-sectional view of an atrial shunt delivery device during delivery according to an embodiment of the present application;

FIG. 3 is a schematic cross-sectional view of an atrial shunt provided in accordance with an embodiment of the present application;

FIG. 4 is a front view of an atrial shunt according to an embodiment of the present application;

FIG. 5 is a flow chart illustrating an atrial shunt delivery method according to an embodiment of the present application.

Icon: 1-an atrial shunt delivery device; 10-fixing a pressure pipe; 101-internal threads; 20-a puncture mechanism; 201-puncture rod; 2011-external threads; 202-a piercing member; 2021-a puncturing part; 2022-flare; 30-an atrial shunt; 301-left disc; 302-right disc; 303-connecting the channel; 40-installation clearance; 50-a delivery catheter.

Detailed Description

The technical solutions in the embodiments of the present application will be described below with reference to the drawings in the embodiments of the present application.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures. Meanwhile, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not to be construed as indicating or implying relative importance.

Currently, conventional ostomy procedures typically employ a puncture sheath to puncture and create a hole in the atrial septum site and a balloon to dilate the defect. Because instruments need to be conveyed for many times in the operation process so as to complete the steps of puncture, expansion and conveying in sequence, the implantation process of the atrial shunt is complicated, the implantation time is long, and the operation risk is high.

Referring to fig. 1, in a first aspect, embodiments of the present application provide an atrial shunt delivery device 1, including: the fixed pressure pipe 10 is provided with an installation channel; an atrial shunt 30 disposed outside the fixed pressure tube 10; the puncture mechanism 20 comprises a puncture rod 201 arranged in the installation channel and a puncture piece 202 connected with the puncture rod 201, wherein the puncture piece 202 is arranged at one end of the fixed pressure pipe 10 and is positioned outside the fixed pressure pipe 10; wherein, an installation gap 40 is arranged between the puncture piece 202 and the fixed pressure pipe 10, and the atrium shunt delivery device 1 is partially arranged in the installation gap 40.

In the above implementation, the atrial shunt delivery device 1 includes a fixed pressure tube 10, an atrial shunt 30, and a puncture mechanism 20. Wherein the fixed pressure pipe 10 is provided with an installation channel. The puncture rod 201 of the puncture mechanism 20 is arranged in the fixed pressure tube 10, the puncture piece 202 is positioned at one end of the fixed pressure tube 10 and is connected with the puncture rod 201, and an installation gap 40 for fixing the atrial shunt 30 is arranged between the puncture rod 201 and the fixed pressure tube 10. The atrial shunt 30 is disposed around the circumference of the fixed pressure tube 10 and is partially secured within the mounting gap 40 defined between the piercing member 202 and the fixed pressure tube 10 to prevent dislodgement during delivery. Specifically, when carrying atrium shunt 30, the first atrial septum puncture that carries out of puncture piece 202 of accessible self, need not to carry the puncture sheath and accomplish the atrial septum puncture, puncture and can use the expander to expand the puncture hole after finishing, continue the propelling movement after the expansion finishes, carry to the atrial septum until connecting channel 303 of atrium shunt 30, owing to alright realize the operation of atrial septum puncture in transportation process, the number of times of transporting the apparatus in the operation process has been reduced, thereby operation time has been shortened, the risk of operation has been reduced.

Referring to fig. 1, in one possible implementation, the inner wall surface of the end of the fixed pressure tube 10 facing the puncturing element 202 is provided with an internal thread 101, the puncturing rod 201 is provided with an external thread 2011, and the fixed pressure tube 10 is in threaded connection with the puncturing rod 201 and defines a mounting gap 40 for fixing the atrial shunt 30 with the puncturing element 202.

In the implementation process, the inner wall surface of one end of the fixed pressure tube 10 facing the puncture piece 202 is provided with the internal thread 101, and the end of the puncture rod 201 connected with the puncture piece 202 is provided with the external thread 2011, so that when the atrial shunt 30 is fixed, part of the atrial shunt 30 can be firstly arranged in the installation gap 40 between the fixed pressure tube 10 and the puncture piece 202, and then the atrial shunt 30 is locally pressed in the installation gap 40 by screwing the fixed pressure tube 10 and the puncture rod 201, so that the risk that the atrial shunt 30 falls off in the conveying process is prevented, and the efficiency of conveying the atrial shunt 30 is further improved.

In one possible implementation, the puncture element 202 includes a puncture portion 2021, and the diameter of the puncture portion 2021 gradually decreases in a direction away from the fixed pressure tube 10.

In the implementation process, the puncture element 202 includes the puncture portion 2021, and the diameter of the puncture portion 2021 gradually decreases from one end connected to the puncture rod 201 to the other end, i.e., the puncture portion 2021 is tapered, so as to facilitate the puncture operation and enable the atrial shunt 30 to be continuously delivered after the puncture.

In a possible implementation manner, the puncture element 202 further includes an expansion portion 2022, and the expansion portion 2022 is in circular-arc transition connection with an end of the puncture portion 2021 close to the fixed pressure tube 10 and extends to the outside of the fixed pressure tube 10.

In the above implementation process, the puncturing part 202 further includes an expanding part 2022, which is connected with the puncturing part 2021 and the puncturing rod 201 in a transition manner by an arc, wherein the expanding part 2022 is in a cylindrical structure and extends to the outside of the fixed pressure tube 10 for expanding the stoma after the puncturing operation, so that the atrial shunt 30 is implanted into the interatrial space, and since there is no need to deliver an expanding device after the puncturing operation, the operation time is further reduced, and the operation risk can be further reduced. At the same time, the expanded stoma size fits the size of the atrial shunt 30, improving the accuracy of the stoma size.

Referring to fig. 3 and 4, in one possible implementation, the atrial shunt 30 includes a left disc 301 and a right disc 302 connected to the left disc 301, with a connecting channel 303 defined between the left disc 301 and the right disc 302, and the fixed pressure tube 10 is located within the connecting channel 303.

In the above implementation, the atrial shunt 30 comprises a left disc 301 and a right disc 302, a connecting channel 303 is defined between the left disc 301 and the right disc 302, the connecting channel 303 is used for being disposed at the interatrial septum and allowing blood to flow from the left atrium to the right atrium, and the left disc 301 and the right disc 302 are respectively disposed at the left atrium and the right atrium and clamped at two sides of the stoma to play a role in fixing so as to prevent the stoma from closing. The size of the connecting channel 303 can be adjusted according to the requirement to adjust the blood flow distribution, so as to meet the treatment requirements of patients with heart failure of different degrees.

Referring to fig. 2, in a possible implementation manner, the method further includes: and a delivery catheter, which is sleeved outside the fixed pressure pipe 10 and the atrial shunt 30 and is used for pressing the atrial shunt 30.

In the implementation process, the atrial shunt delivery apparatus 1 further includes a delivery catheter 50 sleeved outside the fixed pressure tube 10 and the atrial shunt 30, and the delivery catheter 50 can compress the atrial shunt 30 between the delivery catheter 50 and the fixed pressure tube 10, so as to improve the safety of the atrial shunt 30 during the delivery process.

In one possible implementation, the inner wall surface of the connection channel 303 is coated with a first coating for reducing the blood flow resistance.

In the implementation process, the inner wall surface of the connecting channel 303 is coated with the first coating film, the first coating film can be made of polytetrafluoroethylene or a microporous film formed by pressing polytetrafluoroethylene and a fabric, and the inner wall surface of the connecting channel 303 can be smoother by the first coating film, so that blood resistance is reduced, and thrombus risk is reduced.

In one possible implementation, the outer surface of the atrial shunt 30 is coated with a second coating that serves to inhibit endothelialization.

In the implementation process, the outer surface of the atrial shunt 30 is coated with a second coating film, which is a drug coating film, such as rapamycin, paclitaxel and the like, so as to inhibit endothelialization of the device and prevent the closure of the stoma.

In one possible implementation, the left disc 301 and the right disc 302 are both elastic members.

In the implementation process, the left disc 301 and the right disc 302 are both elastic pieces, so that the left disc 301 and the right disc 302 can be compressed and deformed in the conveying process conveniently, and can release elastic potential energy after being implanted to restore the original state, so as to play roles of fixing and clamping the stoma and preventing the stoma from being closed.

In one possible implementation, the left disc 301 and the right disc 302 are integrally woven by at least one woven mesh.

In a possible implementation, the left disc 301 and the right disc 302 are respectively woven by at least one woven mesh and laser welded.

Referring to fig. 5, in a second aspect, embodiments of the present application provide an atrial shunt 30 delivery method, suitable for use in the atrial shunt delivery device 1 of any one of the embodiments of the first aspect, including:

step S100: the fixed pressure pipe is sleeved outside the puncture rod, and an installation gap is defined between one end of the fixed pressure pipe and the puncture piece.

Step S102: the atrium shunt is locally arranged in the installation gap and is tightly pressed in a mode of threaded connection of the puncture rod and the fixed pressing pipe.

Step S104: the atrial septum puncture of the heart is performed by the puncture element, and the puncture hole is expanded by the expansion portion of the puncture element.

Step S106: the connecting channel of the atrial shunt is delivered to the interatrial septum stoma and the left and right discs of the atrial shunt are deployed in the left and right atrium, respectively.

Step S108: the fixation of the fixed pressure pipe and the puncture piece to the atrial shunt is released, and the left disc and the right disc of the atrial shunt are respectively clamped on two sides of the interatrial septum stoma.

The atrial shunt delivery method provided by the embodiment of the second aspect of the application can complete the purposes of puncturing, expanding and delivering the atrial shunt at one time while delivering the atrial shunt, thereby effectively reducing the times of auxiliary interventional devices, shortening the operation time and reducing the operation risk.

The above description is only an example of the present application and is not intended to limit the scope of the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present application, and shall be covered by the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

It is noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

Claims (10)

1. An atrial shunt delivery device, comprising:

the fixed pressure pipe is provided with an installation channel;

the atrium shunt is arranged outside the fixed pressing pipe;

the puncture mechanism comprises a puncture rod arranged in the installation channel and a puncture piece connected with the puncture rod, and the puncture piece is arranged at one end of the fixed pressure pipe and is positioned outside the fixed pressure pipe;

wherein, be equipped with the installation clearance between puncture piece and the fixed pressure pipe, atrium shunt conveyor part is located in the installation clearance.

2. The atrial shunt delivery device of claim 1,

the fixed pressure pipe orientation the internal face of the one end of puncture piece is equipped with the internal thread, the puncture rod is equipped with the external screw thread, fixed pressure pipe with puncture rod threaded connection, and with inject between the puncture piece and be used for fixing the atrium shunt installation clearance.

3. The atrial shunt delivery device of claim 1 or 2,

the puncture piece comprises a puncture part, and the diameter of the puncture part is gradually reduced towards the direction far away from the fixed pressure pipe.

4. The atrial shunt delivery device of claim 3,

the puncture piece further comprises an expansion part, and the expansion part is in arc transition connection with one end, close to the fixed pressure pipe, of the puncture part and extends to the outside of the fixed pressure pipe.

5. The atrial shunt delivery device of claim 1 or 2, further comprising:

and the conveying catheter is sleeved outside the fixed pressing pipe and the atrial shunt and used for pressing the atrial shunt.

6. The atrial shunt delivery device of claim 1 or 2,

the atrium shunt comprises a left disc and a right disc connected with the left disc, a connecting channel is defined between the left disc and the right disc, and the fixed pressing pipe is located in the connecting channel.

7. The atrial shunt delivery device of claim 6,

the inner wall surface of the connecting channel is coated with a first coating film, and the first coating film is used for reducing the blood circulation resistance; and/or

The outer surface of the atrial shunt is coated with a second coating for inhibiting endothelialization.

8. The atrial shunt delivery device of claim 6,

the left disc and the right disc are both elastic pieces.

9. The atrial shunt delivery device of claim 6,

the left disc and the right disc are integrally woven through at least one woven net; or

The left disc and the right disc are respectively woven through at least one woven mesh and are formed by laser welding.

10. An atrial shunt delivery method adapted for use with the atrial shunt delivery device of any one of claims 1 to 9, comprising:

sleeving a fixed pressure pipe outside the puncture rod, and defining an installation gap between one end of the fixed pressure pipe and the puncture piece;

the atrium shunt is partially arranged in the installation gap and is tightly pressed in a mode of threaded connection of the puncture rod and the fixed pressure pipe;

performing atrial septal puncture of the heart by the puncture piece, and expanding the puncture hole by the expansion part of the puncture piece;

delivering the connecting channel of the atrial shunt to the interatrial septum stoma and deploying the left and right discs of the atrial shunt to the left and right atria, respectively;

and releasing the fixation of the fixed pressure pipe and the puncture piece on the atrial shunt, and respectively clamping the two sides of the interatrial septum stoma by the left disc and the right disc of the atrial shunt.

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