CN113729800A - Shunt device for atrium - Google Patents
Shunt device for atrium Download PDFInfo
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- CN113729800A CN113729800A CN202111029141.2A CN202111029141A CN113729800A CN 113729800 A CN113729800 A CN 113729800A CN 202111029141 A CN202111029141 A CN 202111029141A CN 113729800 A CN113729800 A CN 113729800A
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- atrium
- braided
- wall fixing
- shunt device
- fixing structure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a shunt device for an atrium. A shunt device for atrium comprises a middle channel structure, wherein both sides of the middle channel structure are respectively provided with a left atrium wall fixing structure and a right atrium wall fixing structure; the left atrium wall fixed structure is a braided net structure formed by braiding braided wires through a braiding process, and the braided net structure comprises at least two braided layers. Compared with the traditional single-layer woven structure, the multi-layer woven structure has the advantages that the waist supporting force is improved, the opening blockage caused by excessive endothelialization is reduced, the atrial pressure is reduced, the cardiac pressure of a patient is improved, and the service life of the patient is prolonged.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a shunt device for an atrium.
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.
HFpEF is heart failure with an ejection fraction greater than 50%, and is mainly manifested by a decrease in diastolic function and compliance, but not systolic function. Clinical epidemiological data have shown that over half of the hospitalized heart failure population is HFpEF or HFmrEF, and that HFpEF has similar long-term mortality and complication rates as hfrref, indicating that HFpEF has a significantly increased incidence over the past 15 years, possibly associated with aging of the population. HFpEF is mainly found in elderly patients, and postmenopausal women, obesity, hypertension, diabetes, microangiopathic myocardial ischemia and the like are risk factors of HFpEF, and the incidence of HFpEF is expected to continue to increase year by year in modern society with an increasing aging trend of the population.
The main pathophysiological processes of HFpEF include systemic inflammation, epicardial adipose tissue inflammation and accumulation, lipoinflammatory factor secretion, coronary microcirculation vascular dysfunction, myocardial fibrosis, impaired left ventricular diastolic filling function due to increased ventricular-arterial stiffness, etc., elevated left ventricular diastolic filling pressure, and further left atrial dysfunction, elevated left atrial filling pressure, and electrical activity disorders. HFpEF is clinically manifested by elevated Left Ventricular End Diastolic Pressure (LVEDP) and elevated pulmonary arteriolar wedge pressure (PCWP)/Left Atrial Pressure (LAP) at rest and under load, ultimately leading to pulmonary edema and post-capillary pulmonary hypertension.
At present, no effective treatment means exists for HFpEF, and research shows that the conventional treatment of HFpEF such as an angiotensin channel inhibitor, a beta receptor blocker, an aldosterone receptor antagonist, a calcium ion antagonist and the like can partially reverse ventricular hypertrophy, relax cardiac muscle and improve diastolic function, but cannot improve the prognosis of patients and reduce cardiovascular death rate. 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 two existing technologies in the clinical stage are mainly two, one is a nickel-titanium alloy atrium shunt, and the other is a shunt device adopting single-layer weaving, and the two modes are proved to be effective clinically, but the alloy structure has high overall strength, a large-size conveying device is required to be used, and the injury to patients is large; the single-layer woven atrial shunt device adopts a single-layer structure, although a small-sized delivery device can be used, the radial supporting force is insufficient, and the opening is easily blocked again due to over-endothelialization.
Therefore, it is necessary to improve it to overcome the disadvantages in practical applications.
Disclosure of Invention
The invention aims to solve the technical problems that the atrial shunt device in the prior art is too strong, a large-size conveying device is required to be used, or the supporting force is insufficient, so that the atrial shunt device is easy to re-block.
A shunt device for atrium comprises a middle channel structure, wherein both sides of the middle channel structure are respectively provided with a left atrium wall fixing structure and a right atrium wall fixing structure;
the left atrium wall fixed knot constructs the net structure of weaving that the knitting silk warp knitting technology was woven and is formed, it includes two at least layer weaving layers to weave net structure.
The left atrium wall fixed knot constructs to middle access structure slope sets up, the cross section of left atrium wall fixed knot constructs with the contained angle of middle access structure is the acute angle.
The included angle is 40-80 degrees.
The left atrium wall fixing structure is formed by weaving at least two weaving wires.
The braided wire is one or a combination of a nickel-titanium wire and a platinum-iridium wire.
The diameter of the knitting silk is 0.08mm-0.15 mm.
The braided net structure is composed of 2-4 braided layers, and preferably the braided net structure is a double-layer braided net structure composed of two braided layers.
The middle channel structure and the right atrium wall fixing structure adopt the same braided wires and the same layers of braided layers as the left atrium wall fixing structure;
the left atrium wall fixing structure, the middle channel structure and the right atrium wall fixing structure are integrally woven and formed through heat setting.
The diverging device still includes:
a delivery device connecting structure, the far end of which is connected with the right atrium wall fixing structure, and the near end of which can be connected with the delivery device.
The conveyer connecting structure is of a hollow cylinder structure, and the far end of the conveyer connecting structure is bundled and fixed with the braided wire in a pressing mode.
And a circle of clamping grooves are formed in the outer circumferential surface of the conveyor connecting structure, and the clamping grooves are used for clamping the external snare to recover the shunting device.
The near end of the conveyor connecting structure is provided with internal threads or external threads, and the conveyor connecting structure is in threaded connection with the conveying device through the internal threads or the external threads.
The material of the conveyor connecting structure is one or a combination of stainless steel, nickel-titanium alloy and platinum-iridium alloy.
The diverging device still includes:
and the connecting channel penetrates through the middle parts of the left atrium wall fixing structure, the middle channel structure and the right atrium wall fixing structure.
The diameters of the left atrium wall fixing structure and the right atrium wall fixing structure are both 15mm-25 mm;
the middle channel structure is a hollow cylinder structure with openings at the left end and the right end, the middle part of the hollow cylinder structure is used as the connecting channel, the outer circumferential surface end part at the near end of the middle channel structure is connected with the right atrium wall fixing structure, and the outer circumferential surface end part at the far end of the middle channel structure is connected with the left atrium wall fixing structure;
the inner diameter of the hollow cylinder structure is 3mm-15mm, and the length of the hollow cylinder structure is 5mm-15 mm.
The positive progress effects of the invention are as follows: the invention adopts the shunt device for the atrium and the braided structure, and compared with the traditional alloy structure device, the invention can use a conveying device with smaller specification, thereby reducing the injury to patients, and improving the success rate of the operation and the convenience of the operation. The shunt device adopts a multi-layer woven structure, and compared with a traditional single-layer woven structure, the waist support force is improved, the opening blockage caused by excessive endothelialization is reduced, the atrial pressure is reduced, the cardiac pressure of a patient is improved, and the service life of the patient is prolonged.
Drawings
FIG. 1 is a perspective view of the present invention;
FIG. 2 is a cross-sectional view of the present invention;
FIG. 3 is a front view of the present invention;
FIG. 4 is a side view of the present invention;
FIG. 5 is a schematic release diagram of a left atrial wall anchoring structure in the practice of the present invention;
FIG. 6 is a schematic release diagram of the right atrial wall anchoring structure and the medial channel structure in the practice of the present invention;
fig. 7 is a schematic view of a full release of the shunt device in the practice of the present invention.
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. 1-4, a shunt device 100 for an atrium includes a left atrial wall fixation structure 102, a middle channel structure 103, and a right atrial wall fixation structure 104. The left atrial wall fixing structure 102 and the right atrial wall fixing structure 104 are respectively disposed at two sides of the middle channel structure 103, and a connecting channel 105 penetrates through the middle of the left atrial wall fixing structure 102, the middle of the middle channel structure 103, and the middle of the right atrial wall fixing structure 104.
The left atrial wall fixation structure 102 is a braided mesh structure formed by braiding braided filaments through a braiding process, and the braided mesh structure includes at least two braided layers. The left atrial wall fixation structure 102 is woven from at least two braided filaments. The braided wire is one or the combination of a nickel-titanium wire and a platinum-iridium wire. The diameter of the braided wire is 0.08mm-0.15 mm. The braided net structure is composed of 2-4 braided layers, namely one braided layer is formed by braiding braided wires through a braiding process, and the final braided net structure is formed by multiple braided layers. Preferably, the knitted mesh structure is a double-layer knitted mesh structure consisting of two knitted layers. The double-layer woven mesh structure has better elasticity and fatigue resistance on the basis of saving materials, and can provide enough supporting force to prevent the stoma from being blocked due to over endothelialization.
The left atrial wall fixation structure 102 and the right atrial wall fixation structure 104 are each 15mm-25mm in diameter.
The middle access structure 103 and the right atrial wall fixation structure 104 use the same braided wires and the same number of layers of braided layers as the left atrial wall fixation structure 102. Preferably, the left atrial wall fixation structure 102, the middle channel structure 103 and the right atrial wall fixation structure 104 are integrally woven and then formed by heat setting. The above process of the present invention can provide sufficient structural stability while facilitating fabrication.
The middle channel structure 103 is a hollow cylinder structure with openings at the left end and the right end, the middle part of the hollow cylinder structure is used as a connecting channel 105, the outer circumferential surface end part of the near end of the middle channel structure 103 is connected with the right atrium wall fixing structure 104, and the outer circumferential surface end part of the far end of the middle channel structure 103 is connected with the left atrium wall fixing structure 102; the hollow cylinder structure has an inner diameter of 3mm-15mm and a length of 5mm-15 mm.
Referring to fig. 2, the left atrial wall anchoring structure 102 is inclined toward the central access structure 103, and the cross section of the left atrial wall anchoring structure 102 forms an acute angle with the central access structure 103. The included angle is 40-80 degrees. The left atrial wall fixation structure 102 now forms an inverted "C" shaped structure.
The shunt device 100 further comprises a conveyor connecting structure 101, and the material of the conveyor connecting structure 101 is one or more of stainless steel, nitinol, and pt-ir. The distal end of the delivery device attachment structure 101 is attached to the right atrial wall fixation structure 104 and the proximal end of the delivery device attachment structure 101 is attachable to a delivery device. The proximal end of the conveyor attachment structure 101 is provided with internal or external threads through which the conveyor is threadedly connected. The conveyor connecting structure 101 is a hollow cylinder structure, and the far end of the conveyor connecting structure 101 is tied up and fixed with the knitting silk in a pressing mode to realize connection with the right atrium wall fixing structure 104. A ring of clipping grooves 106 are arranged on the outer circumference of the conveyor connecting structure 101, the outer snare is clipped by the clipping grooves 106 to recover the shunt device 100, and the clipping grooves 106 are preferably arranged on one side close to the far end. The conveyor connecting structure 101 has the functions of fixing the braided wire, connecting with the pusher 201 of the conveying device, and developing under DSA.
In practice, the shunt device 100 of the present invention may be delivered to the ostium of the left and right atrial chambers by a "transseptal technique" (i.e., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium, and then puncturing the septum and passing the catheter into the left atrium) with the aid of an external delivery device. The delivery device is first accessed through the right femoral vein, and then a tool is used to create an ostium in the left and right atrial walls, and finally the shunt device 100 is delivered to the site of the ostium with the aid of the delivery device.
Referring to FIG. 5, the pusher 201 of the delivery device is in communication with the delivery device attachment structure 101, and the pusher 201 is operated to deliver the atrial shunt into the left atrium in the passageway created by the delivery device sheath 202, and the pusher 201 is operated to release the left atrial wall anchoring structure 102 from the delivery device sheath 202 against the left atrial wall.
Referring to fig. 6, the pusher 201 is moved to the right atrium, gradually releasing the middle channel structure 103 while moving, and finally the right atrium wall fixation structure 104 is attached to the right atrium wall.
Referring to fig. 7, after the shunt device 100 is completely released, the adhesion between the shunt device and the atrial wall 300 is checked, the pusher 201 is disconnected from the conveyor connecting structure 101 by operation, and finally the conveyor is withdrawn from the body.
The conveyor connecting structure 101, the left atrial wall fixing structure 102, the middle channel structure 103 and the right atrial wall fixing structure 104 in the embodiment are connected with the left atrium and the right atrium, so that the pressure of the atria is reduced, the service life of the atria is prolonged, the heart failure is relieved, the operation success rate and the operation convenience are improved, and the long-term health of a patient is benefited.
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 (10)
1. A shunt device for atrium comprises a middle channel structure, wherein both sides of the middle channel structure are respectively provided with a left atrium wall fixing structure and a right atrium wall fixing structure;
the left atrium wall fixing structure is characterized in that the left atrium wall fixing structure is a braided net structure formed by braiding braided wires through a braiding process, and the braided net structure comprises at least two braided layers.
2. The shunt device of claim 1, wherein said left atrial wall anchoring structure is braided from at least two of said braided filaments.
3. The shunt device for the atrium of claim 1, wherein the braided wire is one or a combination of a nickel titanium wire, a platinum iridium wire;
the diameter of the knitting silk is 0.08mm-0.15 mm.
4. A shunt device for an atrium according to claim 1, wherein said knitted mesh structure is comprised of 2-4 layers of knitted layers, a single layer of said knitted layer being knitted from said knitted filaments by a knitting process, preferably said knitted mesh structure is a double layer knitted mesh structure comprised of two layers of knitted layers.
5. The shunt device for the atrium of any of claims 1 to 4, wherein said medial passage structure and said right atrial wall anchoring structure employ the same number of said braided wires and the same number of said braided layers as said left atrial wall anchoring structure;
the left atrium wall fixing structure, the middle channel structure and the right atrium wall fixing structure are integrally woven and formed through heat setting.
6. The shunt device for an atrium of claim 1, wherein the shunt device further comprises:
a delivery device connecting structure, the far end of which is connected with the right atrium wall fixing structure, and the near end of which can be connected with the delivery device.
7. The shunt device according to claim 6, wherein the delivery device attachment structure is a hollow cylinder-like structure, and the distal end of the delivery device attachment structure is crimped to secure the braided wire.
8. The shunt device of claim 6, wherein the delivery device attachment structure has a circumferential notch formed in an outer circumference thereof, the notch being configured to receive an outer snare for retrieval of the shunt device.
9. The shunt device for an atrium of claim 6, wherein a proximal end of the delivery device attachment structure is internally or externally threaded and is threadedly coupled to the delivery device via the internal or external threads;
the material of the conveyor connecting structure is one or a combination of stainless steel, nickel-titanium alloy and platinum-iridium alloy.
10. The shunt device for an atrium of claim 1, wherein the shunt device further comprises:
a connecting channel, which penetrates through the middle parts of the left atrium wall fixing structure, the middle channel structure and the right atrium wall fixing structure;
the diameters of the left atrium wall fixing structure and the right atrium wall fixing structure are both 15mm-25 mm;
the middle channel structure is a hollow cylinder structure with openings at the left end and the right end, the middle part of the hollow cylinder structure is used as the connecting channel, the outer circumferential surface end part at the near end of the middle channel structure is connected with the right atrium wall fixing structure, and the outer circumferential surface end part at the far end of the middle channel structure is connected with the left atrium wall fixing structure;
the inner diameter of the hollow cylinder structure is 3mm-15mm, and the length of the hollow cylinder structure is 5mm-15 mm.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111029141.2A CN113729800A (en) | 2021-09-02 | 2021-09-02 | Shunt device for atrium |
| PCT/CN2022/116802 WO2023030494A1 (en) | 2021-09-02 | 2022-09-02 | Atrial shunt device and manufacturing method, and atrial shunt system using shunt device |
| CN202280010015.9A CN117098500B (en) | 2021-09-02 | 2022-09-02 | Atrial shunt, method of manufacture and atrial shunt system employing same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111029141.2A CN113729800A (en) | 2021-09-02 | 2021-09-02 | Shunt device for atrium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113729800A true CN113729800A (en) | 2021-12-03 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111029141.2A Pending CN113729800A (en) | 2021-09-02 | 2021-09-02 | Shunt device for atrium |
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| CN (1) | CN113729800A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023030494A1 (en) * | 2021-09-02 | 2023-03-09 | 晨兴(南通)医疗器械有限公司 | Atrial shunt device and manufacturing method, and atrial shunt system using shunt device |
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| US20070265656A1 (en) * | 2004-03-19 | 2007-11-15 | Aga Medical Corporation | Multi-layer braided structures for occluding vascular defects |
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| US20170273790A1 (en) * | 2014-09-09 | 2017-09-28 | Occlutech Holding Ag | A Flow Regulating Device In The Heart |
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| US20200238059A1 (en) * | 2017-10-31 | 2020-07-30 | Hangzhou Noya Medtech Co., Ltd | Devices, systems, and methods for interatrial shunts |
| US20210045691A1 (en) * | 2018-03-29 | 2021-02-18 | Ip2Ipo Innovations Limited | Method and apparatus |
| CN112402062A (en) * | 2020-12-10 | 2021-02-26 | 启晨(上海)医疗器械有限公司 | Be used for atrium reposition of redundant personnel pressure relief device |
-
2021
- 2021-09-02 CN CN202111029141.2A patent/CN113729800A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070265656A1 (en) * | 2004-03-19 | 2007-11-15 | Aga Medical Corporation | Multi-layer braided structures for occluding vascular defects |
| CN102805673A (en) * | 2012-08-15 | 2012-12-05 | 上海形状记忆合金材料有限公司 | Occluder |
| US20170273790A1 (en) * | 2014-09-09 | 2017-09-28 | Occlutech Holding Ag | A Flow Regulating Device In The Heart |
| US20200238059A1 (en) * | 2017-10-31 | 2020-07-30 | Hangzhou Noya Medtech Co., Ltd | Devices, systems, and methods for interatrial shunts |
| US20210045691A1 (en) * | 2018-03-29 | 2021-02-18 | Ip2Ipo Innovations Limited | Method and apparatus |
| CN111166461A (en) * | 2018-11-09 | 2020-05-19 | 杭州诺生医疗科技有限公司 | Interatrial septum stoma device and interatrial septum stoma system thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023030494A1 (en) * | 2021-09-02 | 2023-03-09 | 晨兴(南通)医疗器械有限公司 | Atrial shunt device and manufacturing method, and atrial shunt system using shunt device |
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