CN111938788B

CN111938788B - Interatrial septum puncture assembly

Info

Publication number: CN111938788B
Application number: CN202010866370.9A
Authority: CN
Inventors: 王召军
Original assignee: Harbin Medical University
Current assignee: Harbin Medical University
Priority date: 2020-08-25
Filing date: 2020-08-25
Publication date: 2021-07-30
Anticipated expiration: 2040-08-25
Also published as: CN111938788A

Abstract

The invention discloses an interatrial septum puncture assembly, relates to the field of medicine, and aims to solve the problem of puncture safety caused by the fact that the distance between the tip of an expansion sheath and an atrium cannot be judged at any time in interatrial septum puncture. The interatrial septum puncture assembly comprises an interatrial septum puncture needle, a dilator and a sheath tube, wherein the dilator comprises a dilator tube body, the dilator tube body comprises a far end, a near end and a central cavity, the near end of the dilator tube body can be provided with a dilator side tube and connected with a three-way joint, the inner wall of the cavity of the dilator tube body is provided with at least one groove, and the groove reaches the far-side tip of the dilator. In the scheme of the invention, in the atrial septal puncture operation, when contrast agent or heparin saline is injected, the contrast agent or the heparin saline can be sprayed out from the tip of the dilator, and the position of the distal end of the dilator can be clearly judged under X-ray or intracardiac ultrasound. The invention is applied to the field of atrial septal puncture.

Description

Interatrial septum puncture assembly

Technical Field

The invention relates to the field of medicine, in particular to an interatrial septum puncture assembly.

Background

With the rapid development of interventional instruments and equipment, the application of cardiac interventional therapy is more and more extensive, so that the atrial septal puncture is more widely applied. In 1959 Ross et al reported animal experimental studies on interatrial puncture, which was first applied clinically by Cope and Rossdeng et al in the same year. In the initial atrial septal puncture, a method of directly puncturing the atrial septal through a right-atrial catheter puncture needle is adopted, the atrial septal puncture method is improved by Brockenbrough, Brawnwald and the like in 1960, a guide wire technology is introduced for the first time, and meanwhile, the puncture needle is improved into a tapered structure with a tapered distal end, so that the operation safety is improved. In 1977 Mullins et al configured an outer sheath for the interatrial septum puncture catheter, further improving the operability and safety of the interatrial septum puncture.

In the interatrial septum puncture operation, after the puncture needle breaks through the interatrial septum, the combination of the sheath tube, the dilator and the puncture needle needs to be continuously pushed forward. At the moment, whether the distance between the needle point of the puncture needle and the free wall of the left room is safe or not can be known through the puncture needle radiography. Then the puncture needle needs to be fixed, the dilator and the sheath tube are pushed forward, but at the moment, the distance between the tip of the dilator and the left atrial wall cannot be known because the contrast medium cannot be injected through the dilator (because the dilator is occupied by the puncture needle), and the risk that the dilator is sent into the left atrium too much and the myocardium is perforated exists. After the needle point of the interatrial septum puncture needle punctures tissues, if the position of the distal end of the dilator cannot be judged, the dilator is possibly sent to the left atrium to cause heart perforation, and the puncture of the aortic root is also possible to be mistaken due to wrong judgment of contrast medium injection through the puncture needle, even an expansion sheath and a sheath tube are sent, so that serious complications needing surgical thoracotomy are caused. In addition, the intracardiac ultrasonic catheter-guided zero-X line interatrial puncture is to generate a microbubble image at the tail end of a sheath tube through heparin physiological saline injected by the sheath tube so as to display the position of the sheath tube, but the existing interatrial puncture assembly cannot synchronously display the position of the tip of an expansion sheath.

Accordingly, there is a need for a new atrial septum puncture assembly that can display the distal tip position of the dilating sheath.

Disclosure of Invention

The invention provides an interatrial septum puncture assembly, which solves the problem of puncture safety caused by the fact that the distance between the tip of an expansion sheath and an atrium cannot be judged at any time in interatrial septum puncture.

The invention discloses an interatrial septum puncture assembly which comprises an interatrial septum puncture needle, an expander and a sheath tube;

the dilator is arranged in the sheath tube, and the interatrial septum puncture needle is arranged in the dilator;

a cavity is arranged in the expander, the front end of the expander is provided with an expander joint, and grooves are symmetrically arranged in the cavity at the rear end of the expander;

the expander joint comprises a tailstock and a connecting body clamped on the tailstock; the tailstock is communicated with the connecting body, a side pipeline is arranged on the connecting body, namely one end of the side pipeline is communicated with the groove, the other end of the side pipeline is connected with the three-way valve, and a sealing ring is arranged at the joint of the tailstock and the connecting body.

Further, the groove extends from the rear end of the dilator to the front end of the dilator.

Further, a pipe body is arranged in the groove.

Further, the number of the grooves is two or more.

Further, the widest part of the groove can be larger than the outer diameter of the body of the interatrial septum puncture needle.

Further, the sealing ring may be made of a bio-elastic material, and the inner diameter thereof is the same as the outer diameter of the puncture needle tube.

Furthermore, a side hole is arranged on the dilator.

Further, a sheath tube hole is formed in the sheath tube, and the size of the sheath tube hole is 0.6 mm.

Further, the side hole of the dilator is positioned closer to the proximal end of the assembly than the sheath hole.

Further, the interatrial septum penetration assembly injects contrast media through the three-way valve.

According to the scheme of the invention, in the atrial septal puncture operation, when the contrast medium is injected, the contrast medium can be sprayed out from the tip of the dilator, so that the position of the distal end of the dilator can be clearly judged. The assembled result of the interatrial septum puncture assembly of the present invention is schematically shown in fig. 1.

The invention has the following advantages:

1. interatrial septum puncture assembly includes interatrial septum pjncture needle, expander and sheath pipe, wherein the expander includes the expander body, the expander body includes distal end, near-end and central cavity, the near-end of expander body can be equipped with the expander side pipe and connect three way connection, the cavity inner wall of expander body is equipped with at least one recess, and the distal pointed end of the direct expander of recess. The combination mode among the components is consistent with the combination mode of the atrial septal puncture sheath applied in the market, and operators do not need special training.

2. The part of the far end of the dilator tube body, which is positioned in the sheath tube, can be provided with a side hole which is communicated with the gap between the sheath tube dilator and the dilator puncture needle gap groove. The dilator, after the sheath tube and the puncture needle are combined, a contrast medium can be injected through the proximal end three-way valve of the sheath tube, the contrast medium flows to the side hole of the dilator through the gap between the sheath tube and the dilator, then enters the groove of the inner wall of the dilator through the side hole of the dilator, and reaches the tip of the far side of the dilator through the groove of the inner wall of the dilator between the dilator and the puncture needle, so that the distance between the dilator and the left atrial wall is displayed.

3. The number of the grooves is two or more.

4. The widest part of the groove can be larger than the outer diameter of the interatrial septum puncture needle tube body. So as to pass more contrast agent instantaneously.

5. The distal end of the sheath tube is provided with a sheath tube hole, and the size of the sheath tube hole is 0.6 mm. The contrast agent injected from the near end of the sheath can be sprayed out of the sheath hole.

6. The sheath tube aperture is located closer to the proximal end than the dilator tip. The contrast agent can be injected through the three-way valve of the sheath to observe whether the distal end of the sheath passes through the interatrial septum.

7. The distal tip of the groove on the dilator is positioned closer to the distal end than the sheath tube aperture. The contrast agent can be injected through the proximal end three-way valve of the sheath tube, flows to the side hole of the dilator through the gap between the sheath tube and the dilator, then enters the groove of the inner wall of the dilator through the side hole of the dilator, and reaches the tip of the distal side of the dilator through the groove of the inner wall of the dilator between the dilator and the puncture needle, so as to display the distance between the dilator and the left atrial wall.

8. When the groove runs through the near and far ends of the inner wall of the whole dilator, an independent side pipe can be designed at the near end of the dilator to be connected with a three-way valve, the dilator injects a contrast medium through the three-way valve, the contrast medium directly reaches the tip of the dilator through the groove of the inner wall of the dilator, whether the head end of the dilator passes through the atrial septum or not is observed, the distance from the head end of the dilator to the left atrial wall is observed, the heart perforation is prevented, and whether the aorta is punctured by mistake or not can be confirmed again through the dispersion speed and the mode of the contrast medium sprayed from the head end of the dilator.

9. The intracardiac ultrasonic catheter-guided zero-X line interatrial puncture can be used for injecting heparin normal saline through a sheath tube to generate a microbubble image at the tail end of the tip of the dilating sheath so as to display the position of the tip of the dilating sheath.

10. Intracardiac supersound pipe guide's zero X line interatrial septum puncture, when the recess runs through the near distal end of the inner wall of whole expander, can be at the solitary side union coupling three-way valve of near end of expander, through three-way valve injection heparin normal saline, through heparin normal saline at the terminal microbubble image of expansion sheath tip production and show expansion sheath tip position, whether the head end of observing the expander passes through the interatrial septum to and the distance of the head end of expander apart from left atrial wall

11. The expander joint is formed in a split mode and comprises a tailstock and a connecting body clamped on the tailstock.

12. And a sealing ring is arranged between the tailstock and the connector.

13. The sealing ring is made of a biological elastic material, and the inner diameter of the sealing ring is the same as the outer diameter of the puncture needle tube body.

Drawings

FIG. 1 is a schematic structural view of a combined three-piece interatrial septum puncture assembly of a dilator with a side tube, a sheath tube and an interatrial septum puncture needle in embodiment 1 of the invention;

FIG. 2 is a schematic view of the structure of the distal tip of the combined dilator with side tube and sheath tube in example 1;

FIG. 3 is a cross-sectional view taken along line P-P of FIG. 2;

FIG. 4 is a cross-sectional view taken along line C of FIG. 2;

FIG. 5 is a sectional view taken along line F-F of FIG. 2;

FIG. 6 is an enlarged view at E of FIG. 2;

FIG. 7 is a schematic view showing the structure of the proximal end of the dilator with a side tube according to example 1;

FIG. 8 is a schematic structural view of a combined three-piece interatrial septum puncture assembly of a dilator without a side tube, a sheath tube and an interatrial septum puncture needle in accordance with embodiment 2 of the present invention;

FIG. 9 is a schematic view showing the structure of the distal end of the dilator according to example 2;

FIG. 10 is a sectional view taken along line B-B of FIG. 9;

FIG. 11 is a sectional view taken along line A-A of FIG. 9;

FIG. 12 is an enlarged view of FIG. 9 at D;

FIG. 13 is a schematic view showing the structure of the proximal end of the dilator without a lateral tube according to example 2.

Detailed Description

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for carrying out the invention, and that various changes in form and details may be made therein without departing from the spirit and scope of the invention in practice.

To make the objects, aspects and advantages of the embodiments of the present invention more apparent, the following detailed description clearly illustrates the spirit of the disclosure, and any person skilled in the art, after understanding the embodiments of the disclosure, may make changes and modifications to the technology taught by the disclosure without departing from the spirit and scope of the disclosure.

The exemplary embodiments of the present invention and the description thereof are provided to explain the present invention and not to limit the present invention.

Example 1:

as shown in fig. 1 to 7, the transseptal puncture assembly 10 includes a transseptal needle 11, a dilator 12, and a sheath 13. Wherein the dilator comprises a dilator tube comprising a distal end, a proximal end and a central chamber, the proximal end of the dilator tube being provided with a dilator lateral tube 44 and a three-way valve. The inner wall of the distal cavity of the dilator tube is provided with at least one groove 23. The number of the grooves can be two or more, and the person skilled in the art can determine the actual requirement. One end of the groove is directly connected to the tip of the dilator, and the other end of the groove can extend to the near end of the dilator tube body and is connected with the three-way valve through a side tube. The contrast agent flows along the groove to the tail end of the dilator tube and is sprayed out. The groove can also be internally provided with a tube body, and the contrast agent flows to the tail end of the dilator tube body along the tube body and is sprayed out. The groove of the expander is communicated with the near end of the whole expander tube body, and a side tube at the near end of the expander is arranged and can be connected with the groove on the inner wall of the expander and the three-way tube. Those skilled in the art can determine the actual needs.

The expander joint can be of an integrated structure or a split structure. According to an embodiment of the present invention, the expander joint is a separate structure, and includes a tail seat 41 and a connecting body 42 clamped on the tail seat, and the tail seat and the connecting body may be fixed by bonding or other suitable means. The connector is provided with a side tube 44 which can be connected with a luer connector and is used for injecting contrast medium into the dilator. A sealing ring 43 is arranged between the tailstock and the connector, the sealing ring can be made of a biological elastic material, the inner diameter of the sealing ring is the same as the outer diameter of the puncture needle body, and the inner diameter of the sealing ring can also be approximately the same as the outer diameter of the puncture needle body, so that the back leakage of the contrast agent is prevented.

Example 2:

as shown in fig. 8 to 13, the transseptal puncture assembly 10 includes a transseptal needle 11, a dilator 12, and a sheath 13. Wherein the dilator comprises a dilator tube comprising a distal end, a proximal end and a central lumen, the proximal end of the dilator tube being provided with a dilator-side tube connector 14. The inner wall of the distal cavity of the dilator tube is provided with at least one groove 23. The number of the grooves can be two or more, and the person skilled in the art can determine the actual requirement. In this embodiment, the grooves do not extend to the proximal end of the dilator body, and therefore there is no side tube at the proximal end of the dilator. The widest position of the groove is larger than the outer diameter of the interatrial septum puncture needle tube body. The contrast agent flows along the groove to the tail end of the dilator tube and is sprayed out.

The groove can also be internally provided with a tube body, and the contrast agent flows to the tail end of the dilator tube body along the tube body and is sprayed out. The grooves do not extend through the entire dilator tube, and can be determined by those skilled in the art according to actual needs.

After the dilator tube body is combined with the sheath tube, the part of the dilator, which is positioned inside the sheath tube, is provided with a side hole 24, the far end of the sheath tube is provided with a sheath tube hole 31, and the size of the sheath tube hole is 0.6 mm. When the interatrial septum puncture assembly is in use, the dilator extends within the sheath with its distal end extending outside the distal end of the sheath. At the moment, the position of the side hole on the dilator is closer to the near end than the position of the hole of the sheath tube, namely, the side hole on the dilator is covered by the inner wall of the sheath tube, but a gap is arranged between the outer wall of the dilator and the inner wall of the sheath tube. When contrast agent is injected into the sheath through the side of the proximal end of the sheath, the contrast agent can flow to the distal end along the gap between the sheath and the expansion tube, one part of the contrast agent enters the expansion tube along the side hole of the expansion tube, advances along the groove and is sprayed out from the tail end of the expansion tube, and the other part of the contrast agent flows out from the hole of the sheath. This allows for simultaneous display of the sheath and dilator distal head positions.

The expander joint 14 can be of unitary or split construction. According to an embodiment of the present invention, the expander joint is a separate structure, and includes a tail seat 41 and a connecting body 42 clamped on the tail seat, and the tail seat and the connecting body may be fixed by bonding or other suitable means. A sealing ring 43 is arranged between the tailstock and the connector, the sealing ring can be made of a biological elastic material, the inner diameter of the sealing ring is the same as the outer diameter of the puncture needle body, and the inner diameter of the sealing ring can also be approximately the same as the outer diameter of the puncture needle body, so that the back leakage of the contrast agent is prevented.

Claims

1. An interatrial septum puncture assembly is characterized by comprising an interatrial septum puncture needle (11), an expander (12) and a sheath tube (13);

the dilator (12) is arranged in the sheath tube (13), and the interatrial septum puncture needle (11) is arranged in the dilator (12);

a cavity is arranged in the expander (12), an expander joint (14) is arranged at the front end of the expander, and grooves (23) are symmetrically arranged in the cavity at the rear end of the expander;

the expander joint (14) comprises a tailstock (41) and a connecting body (42) clamped on the tailstock; the tailstock (41) is communicated with the connecting body (42), a side pipeline (44) is arranged on the connecting body (42), namely one end of the side pipeline (44) is communicated with the groove (23), the other end of the side pipeline is connected with the three-way valve, and a sealing ring (43) is arranged at the joint of the tailstock (41) and the connecting body (42); the groove (23) extends from the proximal end of the dilator to the distal end of the dilator; a side hole is arranged on the expander (12); the side hole of the dilator is closer to the proximal end of the assembly than the position of the sheath tube hole; the interatrial septum puncture assembly (10) injects contrast media through a three-way valve (15).

2. A transseptal puncture assembly as claimed in claim 1, wherein a tube is provided in said recess (23).

3. A transseptal puncture assembly as claimed in claim 2, wherein the number of recesses (23) is two or more.

4. A transseptal puncture assembly as claimed in claim 3, wherein the widest part of the groove (23) is larger than the outer diameter of the tubular body of the transseptal needle (11).

5. A transseptal puncture assembly as claimed in claim 1, wherein the sealing ring (43) is made of a bio-elastic material and has an inner diameter equal to the outer diameter of the puncture needle tube.

6. A transseptal puncture assembly according to claim 1, wherein the sheath (13) is provided with sheath holes having a size of 0.6 mm.