A delivery system for a cardiac shunt

Abstract

The present invention relates to a delivery system for a cardiac shunt, and the operating steps are as follows: a) a delivery sheath is combined with a puncture sheath and a puncture needle to enter the atrium and puncture the atrial septum. After completion, the puncture sheath and puncture needle are withdrawn, leaving the delivery sheath in the body; b) a release shaft is passed through a straightening sheath, a threaded hole of the cardiac shunt is screwed to a screw at one end of the release shaft, the release shaft is slid to retract the cardiac shunt into the straightening sheath, and a locking knob is turned to control a tension sleeve to clamp the release shaft; c) the straightening sheath (b) is clamped and connected to the delivery sheath, the locking knob is turned to control the tension sleeve to just loosen the release shaft, and the release shaft is slid to allow the cardiac shunt to enter the delivery sheath; d) the release shaft is then continued to slide to allow the cardiac shunt to extend from the other end of the delivery sheath and restore its umbrella-shaped structure, and then clamped to the target atrial septum; e) a handle is turned to disengage the release shaft from the cardiac shunt, and the delivery system is then withdrawn from the body. The present invention has a simple structure, is easy to operate, and greatly improves safety.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiac shunts, and in particular to a delivery system for cardiac shunts. Background Art

[0002] Heart failure is the final manifestation of cardiomyopathy caused by various causes. Epidemiological data show that in the United States alone, there are 6.2 million adults with heart failure. Due to my country's large population, the number of heart failure patients exceeds 10 million. Without effective treatment, the five-year survival rate for chronic heart failure is less than 50%, and the five-year mortality rate for acute heart failure is as high as 60%.

[0003] According to current guidelines, heart failure can be divided into three categories: heart failure with reduced ejection fraction (HFrEF), heart failure with intermediate ejection fraction (HFmrEF), and heart failure with preserved ejection fraction (HFpEF).

[0004] FpEF clinically manifests as elevated LVEDP at rest and under stress, as well as elevated pulmonary capillary wedge pressure (PCWP) or left atrial pressure (LAP), ultimately leading to pulmonary edema and post-capillary pulmonary hypertension. Due to the significant differences in the pathogenesis of HFpEF and HFrEF, there is currently no effective treatment for HFpEF. Studies have shown that traditional treatments for HFpEF, such as angiotensin-converting enzyme inhibitors, beta-blockers, aldosterone receptor antagonists, and calcium ion antagonists, can partially reverse ventricular hypertrophy, relax the myocardium, and improve diastolic function, but they do not improve patient prognosis or reduce cardiovascular mortality. Treatments for HFpEF include diuretics to reduce volume overload, control hypertension and diabetes, and control atrial fibrillation (AF), but ideal clinical results have yet to be achieved.

[0005] The clinical symptoms of patients with heart failure (HFpEF) are primarily due to pulmonary vascular congestion caused by elevated PCWP and LAP (i.e., left atrial overload). The degree of PCWP elevation is positively correlated with clinical symptoms, long-term mortality, and prognosis. Compared with the normal population, patients with HFpEF have significantly elevated PCWP at rest and under load. This elevated PCWP is also significantly positively correlated with decreased maximal oxygen consumption (VO2). The latter is a quantitative indicator of exercise tolerance and can serve as an independent predictor of prognosis in patients with heart failure. These clinical observations confirm that patients with HFpEF often present with left atrial overload and pulmonary congestion, which in turn leads to decreased exercise tolerance. Therefore, reducing left ventricular system pressure in patients has become a potential therapeutic target for HFpEF. Early clinical experience has demonstrated that patients with Ludenbach syndrome (mitral stenosis combined with atrial septal defect) experience later onset of clinical symptoms and are less severe than those with isolated mitral stenosis. This mechanism is attributed to the fact that shunting caused by the atrial septal defect reduces LAP, thereby alleviating clinical symptoms. Compared to the left heart, the right heart has a better tolerance for volume overload and can serve as a potential vessel for left ventricular volume overload. When left atrial overload is caused by left ventricular diastolic dysfunction, creating a stable and controllable left-to-right intracardiac shunt can effectively reduce LAP, converting decompensated volume overload to compensatory one without significantly reducing left ventricular output volume requirements. This technology has become an important and potentially effective treatment for HFpEF. Given this mechanism, the emerging interatrial septal shunt device has emerged.

[0006] Disclosed is a delivery system for an atrial shunt, application number CN2020116278120. The delivery system includes a first sheath structure, a second sheath structure, and an inner core tube structure. The second sheath structure is connected to the first sheath structure and the inner core tube structure. The first sheath structure is used for puncturing and expanding the atrial septum, the second sheath structure is used for constricting the atrial shunt, and the inner core tube structure is connected to the atrial shunt to allow the atrial shunt to reach the atrial septum and be released. The delivery system releases the atrial shunt through structures such as clamps and gears. The entire delivery system is cumbersome to assemble, and the structure and operation of releasing the atrial shunt are complex. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a delivery system for a cardiac shunt, which has a simple structure and is easy to assemble. The locking knob is turned to control the clamping sleeve to clamp or loosen the release shaft, which is easy to operate and greatly improves safety.

[0008] The technical solution adopted by the present invention to solve its technical problems is: to provide a delivery system for a cardiac shunt, including a release shaft, a delivery sheath and a straightening sheath, one end of the straightening sheath is connected to the delivery sheath, and a release shaft is slidably installed in the straightening sheath, one end of the release shaft passes through the delivery sheath and is screwed with a cardiac shunt, and the cardiac shunt can be retracted into the delivery sheath, the other end of the release shaft passes through the straightening sheath and is installed with a handle, the other end of the straightening sheath is rotatably installed with a locking knob, and the other end of the straightening sheath is embedded with a tensioning sleeve, the release shaft passes through the tensioning sleeve, and the locking knob is rotated to control the tensioning sleeve to clamp or release the release shaft.

[0009] As a supplement to the technical solution of the present invention, the straightening sheath and the delivery sheath are fixed by screw thread connection or clamping.

[0010] As a supplement to the technical solution of the present invention, the tension sleeve is made of silicone.

[0011] As a supplement to the technical solution of the present invention, both the delivery sheath and the straightening sheath are provided with an exhaust tube.

[0012] As a supplement to the technical solution described in the present invention, the cardiac shunt includes an umbrella-shaped front disc and a rear disc, the front disc and the rear disc are connected by a waist, a shunt valve is provided on the waist, and a connecting column is provided on one side of the rear disc, and a threaded hole connected to the release shaft is provided on the connecting column.

[0013] As a supplement to the technical solution of the present invention, the cardiac shunt is made of a memory alloy wire mesh or a memory alloy tube laser cut.

[0014] Beneficial effects: The present invention relates to a delivery system for a cardiac shunt. During installation, the delivery sheath is first inserted into the atrium with the puncture sheath and puncture needle to puncture the atrial septum. After puncture is completed, the puncture sheath and puncture needle are withdrawn, leaving the delivery sheath in the body. Then, a release shaft is passed through the straightening sheath, the threaded hole of the cardiac shunt is screwed to the screw at one end of the release shaft, the release shaft is slid to retract the cardiac shunt into the straightening sheath, and the locking knob is turned to control the tension sleeve to clamp the release shaft. The straightening sheath is then clamped and connected to the delivery sheath, the locking knob is turned to control the tension sleeve to just loosen the release shaft, and the release shaft is slid to allow the cardiac shunt to enter the delivery sheath. The release shaft is then continued to slide to allow the cardiac shunt to extend from the other end of the delivery sheath and restore its umbrella-shaped structure, and be clamped on the target atrial septum. Finally, the handle is turned to disengage the release shaft from the cardiac shunt, and the delivery system is withdrawn from the human body. The present invention has a simple structure and is easy to assemble. The locking knob is turned to control the tension sleeve to clamp or loosen the release shaft, making it easy to operate and greatly improving safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a cross-sectional view of the present invention;

[0016] Figure 2 It is a structural schematic diagram of the present invention;

[0017] Figure 3 It is a structural schematic diagram of the cardiac shunt described in the present invention.

[0018] Illustration: 1. Heart shunt, 2. Release shaft, 3. Delivery sheath, 4. Straightening sheath, 5. Locking knob, 6. Tension sleeve, 7. Handle, 8. Evacuation tube, 9. Diverter valve, 10. Front disc, 11. Rear disc, 12. Waist, 13. Connecting column, 14. Threaded hole. DETAILED DESCRIPTION

[0019] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall equally within the scope limited by the appended claims of the application.

[0020] An embodiment of the present invention relates to a delivery system for a cardiac shunt, such as Figure 1-3 As shown, it includes a release shaft 2, a delivery sheath 3 and a straightening sheath 4, one end of the straightening sheath 4 is connected to the delivery sheath 3, and the release shaft 2 is slidably installed in the straightening sheath 4, one end of the release shaft 2 passes through the delivery sheath 3 and is screwed with a cardiac shunt 1, and the cardiac shunt 1 can be retracted into the delivery sheath 3, the other end of the release shaft 2 passes through the straightening sheath 4 and is installed with a handle 7, the other end of the straightening sheath 4 is rotatably installed with a locking knob 5, and the other end of the straightening sheath 4 is embedded with a tensioning sleeve 6, the release shaft 2 passes through the tensioning sleeve 6, and the tensioning sleeve 6 is made of silicone material. The tensioning sleeve 6 is used to prevent blood loss when the release shaft is slid. Turning the locking knob 5 controls the tensioning sleeve 6 to clamp or release the release shaft 2.

[0021] The straightening sheath 4 and the conveying sheath 3 are connected by threaded connection. Threaded connection is just one common solution and is not limited to threaded connection. Other solutions such as clamping connection are also possible.

[0022] The cardiac shunt 1 can also be called an atrial shunt. The cardiac shunt 1 is made of a memory alloy wire mesh or a memory alloy tube laser cut. Figure 3As shown, the cardiac shunt 1 includes an umbrella-shaped front disc 10 and a rear disc 11. The front disc 10 and the rear disc 11 are connected by a waist 12. A shunt valve 9 is provided on the waist 12. A connecting column 13 is provided on one side of the rear disc 11. A threaded hole 14 connected to the release shaft 2 is provided on the connecting column 13.

[0023] Both the conveying sheath 3 and the straightening sheath 4 are provided with an exhaust pipe 8, which is used to exhaust the air inside.

[0024] The overall operation steps of the present invention are as follows:

[0025] a) The delivery sheath 3 is combined with the "puncture sheath and puncture needle" (not a patented device) to enter the atrium and puncture the atrial septum. After completion, the puncture sheath and puncture needle are withdrawn, leaving the delivery sheath 3 in the body;

[0026] b) Pass the release shaft 2 through the straightening sheath 4, screw the threaded hole 14 of the cardiac shunt 1 to the screw at one end of the release shaft 2, slide the release shaft 2 to retract the cardiac shunt 1 into the straightening sheath 4, and turn the locking knob 5 to control the tensioning sleeve 6 to clamp the release shaft 2;

[0027] c) Clamp the straightening sheath 4 obtained in b) to the delivery sheath 3, turn the locking knob 5 to control the tensioning sleeve 6 to just loosen the release shaft 2, and slide the release shaft 2 to allow the cardiac shunt 1 to enter the delivery sheath 3;

[0028] d) Then, the release shaft 2 is continuously slid to allow the cardiac shunt 1 to extend from the other end of the delivery sheath 3 and restore its umbrella-like structure, and to be clamped on the target atrial septum;

[0029] e) Turn the handle 7 to disengage the release shaft 2 from the cardiac shunt 1, and then withdraw the entire delivery system from the human body.

[0030] In the description of the present invention, it should be understood that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "horizontal, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention; the directional words "inside and outside" refer to the inside and outside relative to the outline of each component itself.

[0031] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used herein to describe the spatial positional relationship of a device or feature to other devices or features as shown in the figures. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figures. For example, if the device in the drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0032] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0033] The above is a detailed introduction to the delivery system of a cardiac shunt provided by the present application. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the method of the present application and its core idea. At the same time, for those skilled in the art, according to the ideas of the present application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present application.

Claims

1. A delivery system for a cardiac shunt, characterized in that: The invention comprises a release shaft (2), a delivery sheath (3) and a straightening sheath (4), wherein one end of the straightening sheath (4) is connected to the delivery sheath (3), a release shaft (2) is slidably installed in the straightening sheath (4), one end of the release shaft (2) passes through the delivery sheath (3) and is screwed with a heart shunt (1), and the heart shunt (1) can be retracted into the delivery sheath (3), the other end of the release shaft (2) passes through the straightening sheath (4) and is installed with a handle (7), the other end of the straightening sheath (4) is rotatably installed with a locking knob (5), the other end of the straightening sheath (4) is embedded with a tensioning sleeve (6), the release shaft (2) passes through the tensioning sleeve (6), and is rotated to rotate. The locking knob (5) controls the tensioning sleeve (6) to clamp or loosen the release shaft (2); the cardiac shunt (1) comprises an umbrella-shaped front disc (10) and a rear disc (11), the front disc (10) and the rear disc (11) are connected via a waist (12), a shunt valve (9) is provided on the waist (12), a connecting column (13) is provided on one side of the rear disc (11), and a threaded hole (14) connected to the release shaft (2) is provided on the connecting column (13); the straightening sheath (4) and the delivery sheath (3) are fixed by screw thread or clamping; an emptying tube (8) is provided on both the delivery sheath (3) and the straightening sheath (4).

2. A cardiac shunt delivery system according to claim 1, characterized in that: The tension sleeve (6) is made of silicone material.

3. A cardiac shunt delivery system according to claim 1, characterized in that: The cardiac shunt (1) is made of a memory alloy wire braided mesh or a memory alloy tube laser cut.

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