CN113616256A - Interventional instrument for atrial septum and method of manufacture - Google Patents
Interventional instrument for atrial septum and method of manufacture Download PDFInfo
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- CN113616256A CN113616256A CN202110901860.2A CN202110901860A CN113616256A CN 113616256 A CN113616256 A CN 113616256A CN 202110901860 A CN202110901860 A CN 202110901860A CN 113616256 A CN113616256 A CN 113616256A
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- support frame
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- atrial septum
- cylindrical net
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
Abstract
The invention discloses an interventional instrument for atrial septum and a manufacturing method, the interventional instrument comprises a support frame, a first support frame and a second support frame, wherein the support frame is provided with an expansion state and a contraction state; in the collapsed state, the support frame is collapsed into an elongate configuration; in the deployed state, the support frame comprises: a first support frame having a notch-shaped first passage; a second support frame having a second passage; the first support frame and the second support frame are arranged oppositely, the first passage and the second passage are arranged oppositely, and two ends of the connecting piece are connected to the first support frame and the second support frame respectively. The septum channel can be established again by penetrating through a supporting frame of the interventional device, the gap-shaped passages can allow adjacent interventional devices to be arranged in a staggered mode, adjacent interventional devices cannot be overlapped, and adjacent interventional devices can be clamped and limited mutually.
Description
Technical Field
The present invention relates to the medical field, and further relates to an interventional instrument for atrial septa and a method of manufacture.
Background
The atrial septum is located between the left and right atria and is the septum separating the left and right atria. In some patients with heart disease, abnormal pathways occur due to congenital defects, such as atrial septal defects, patent foramen ovale, and the like.
In addition, non-self-healing defects may also be left in the treatment of certain heart diseases, such as atrial fibrillation electrophysiological treatment, left atrial appendage occlusion, transcatheter mitral valve replacement, transcatheter mitral valve repair, and other left heart minimally invasive procedures.
Currently, for abnormal passages and defects on atrial septum, a transseptal interventional medical device is generally used for closing, such as an occluder, but after the device is used for plugging, a transmembrane passage can not be established on the atrial septum again, which brings great hidden danger to the treatment of subsequent diseases of patients.
In addition, after the patient is closed by using the interventional medical device, if the adjacent positions of the atrial septum are separated again and the two separated positions are close to each other, the reused interventional medical device is inevitably overlapped with the previously used medical device, so that the interventional thickness at the overlapped position is larger, and larger pressure is generated on the atrial septum.
On the other hand, immediately after the insertion of the interventional device into the atrial septum, the interventional device is not sufficiently fused to the atrial septum, and there is a risk of slippage relative to the atrial septum.
Disclosure of Invention
In view of the above technical problems, an object of the present invention is to provide an interventional device for an atrial septum and a manufacturing method thereof, in which at least one of the first support frame and the second support frame of the interventional device is provided with a slit-shaped passage, a transmembrane passage can be formed with a passage on the other support frame, a transmembrane channel can be allowed to be established again by passing through the support frame of the interventional device, the slit-shaped passage can allow adjacent interventional devices to be staggered, adjacent interventional devices cannot be overlapped, and adjacent interventional devices can be clamped and limited with each other.
In order to achieve the above object, the present invention provides a method of manufacturing an interventional instrument for atrial septum, comprising:
weaving a cylindrical net by using metal wires;
forming a first beam-collecting point on a first pre-beam-collecting position of the cylindrical net;
forming a second beam-collecting point on a second pre-collecting position of the cylindrical net;
selecting an intermediate end between the first pre-receiving position and the second pre-receiving position of the cylindrical net to form an intermediate beam-closing point;
the first closing point and the middle closing point are close to each other along the central axis of the cylindrical net, and the cylindrical net between the first closing point and the middle closing point is pressed to form a first supporting frame;
the second closing point and the middle closing point are close to each other along the central axis of the cylindrical net, and the cylindrical net between the second closing point and the middle closing point is pressed to form a second supporting frame;
poking a wire of a first preset point on the first support frame to expand to form a first passage;
poking a second pre-set point of wire on the second support frame to expand to form a second passageway, wherein the first passageway is disposed opposite the second passageway and adapted to form a trans-septal passageway.
Preferably, toggling the wire of the first preset point on the first support frame to expand to form the first pathway comprises: the first preset point is positioned in the peripheral area of the first support frame, and the metal wire of the first preset point is stirred to form the first through hole-shaped passage;
toggling a wire of a second preset point on the second support frame to expand to form a second pathway, comprising: the second preset point is located in the peripheral area of the second support frame, and the metal wire of the second preset point is pushed to form the second through hole-shaped passage.
Preferably, after the wire of the first preset point is pulled to form the first through hole-shaped passage, the method comprises the following steps: pushing the outer edge of the first support frame to move towards the center direction at a first preset point, so that the inner side edge of the first through hole-shaped passage is folded and connected, and the first through hole-shaped passage is formed at the first preset point;
poking the wire at the second preset point to form the second through hole-shaped passage, and then: and pushing the outer edge of the second supporting frame to move towards the center direction at a second preset point, so that the inner side edge of the second channel in the through hole shape is folded and connected, and a notch-shaped second channel is formed at the second preset point.
Preferably, toggling a wire of a first preset point on the first support frame to expand to form a first pathway comprises: pushing the outer edge of the first support frame to move towards the center direction at a first preset point so as to form the first passage in a notch shape at the first preset point;
toggling a wire of a second preset point on the second support frame to expand to form a second pathway, comprising: and pushing the outer edge of the second support frame to move towards the center direction at a second preset point so as to form the second passage in a notch shape at the second preset point.
Preferably, the method for manufacturing an interventional instrument for atrial septum further comprises: and arranging a passage mark on the preset metal wire of the cylindrical net.
Preferably, a first end and a second end of the two ends of the cylindrical net respectively form the first pre-collecting part and the second pre-collecting part; or:
the first end of the cylindrical net is folded inwards or outwards along the axis of the cylindrical net by a preset distance, and then the first end and the corresponding cylindrical net are bunched to form the middle bunching point; a second end of the cylindrical net is converged to form a second beam converging point; and the overlapped ends of the rolled cylindrical net are bunched to form a first beam-collecting point.
According to another aspect of the present invention, the present invention further provides an interventional instrument for atrial septum, comprising a support frame having a deployed state and a collapsed state; in the collapsed state, the support frame is collapsed into an elongate configuration; in the deployed state, the support frame comprises:
a first support frame having a notch-shaped first passage;
a second support frame having a second passage;
the first support frame and the second support frame are arranged oppositely, the first passage and the second passage are arranged oppositely, and two ends of the connecting piece are connected to the first support frame and the second support frame respectively.
Preferably, the first support frame and the second support frame respectively include at least two support arms, adjacent two of the support arms of the first support frame form the first passage, and adjacent two of the support arms of the second support frame form the second passage.
Preferably, one end of each support arm, which is far away from the center of the first support frame or the center of the second support frame, is provided with a first arc-shaped section, a third arc-shaped section is arranged between two adjacent support arms, and the support arms are also provided with a second arc-shaped section positioned between the first arc-shaped section and the third arc-shaped section; the shape of the first arc-shaped section is matched with that of the third arc-shaped section, and one supporting arm of one interventional instrument is suitable for being clamped with the third arc-shaped section between two adjacent supporting arms of the other interventional instrument.
Preferably, the interventional instrument for atrial septum further comprises a blood flow barrier disposed in the first and/or second passageway;
the interventional instrument for atrial septum further comprises access indicia disposed about the first access and/or the second access.
Preferably, a side of the first support frame facing the second support frame is an arc-shaped face;
and/or the side of the second support frame facing the first support frame is an arc-shaped surface.
Preferably, the first support frame has a first distal end face and a first proximal end face;
the support frame further includes a first connector having a first end connected to the first distal face and a second end extending beyond the first proximal face, and the first end has a diameter greater than a diameter of the second end.
Preferably, the second support frame has a second distal end face and a second proximal end face, the second distal end face being disposed opposite the first proximal end face;
the support frame further includes a second connector having a third end connected to the second proximal end face and a fourth end extending beyond the second distal end face, and the third end has a diameter greater than the fourth end.
Preferably, the second proximal end surface has a mounting slot, and the support frame further comprises a first constriction mounted in the mounting slot, the first constriction providing for connection of a delivery device.
Compared with the prior art, the interventional instrument for the atrial septum and the manufacturing method thereof provided by the invention have at least one of the following beneficial effects:
1. according to the interventional device for the atrial septum and the manufacturing method thereof provided by the invention, at least one of the first support frame and the second support frame of the interventional device is provided with a gap-shaped passage which can form a septum penetrating passage with a passage on the other support frame, so that the septum penetrating passage can be established again by the support frame penetrating the interventional device, the gap-shaped passages can allow adjacent interventional devices to be arranged in a staggered manner, the adjacent interventional devices cannot be overlapped, and the adjacent interventional devices can be clamped and limited;
2. according to the interventional device for the atrial septum and the manufacturing method thereof provided by the invention, the first support frame and/or the second support frame of the interventional device are/is respectively provided with a plurality of support arms arranged at intervals, a first passage and/or a second passage are formed between the adjacent support arms, and the plurality of mutually separated support arms can reduce the volume of the support frames in a contraction state, so that the interventional device is conveniently placed;
3. according to the interventional instrument for atrial septum and the manufacturing method thereof provided by the invention, the radian of the first arc-shaped section at the distal end of the supporting arm of the interventional device is matched with the radian of the third arc-shaped section between two adjacent supporting arms, so that the supporting frames can be better staggered with the adjacent supporting frames.
Drawings
The above features, technical features, advantages and modes of realisation of the present invention will be further described in the following detailed description of preferred embodiments thereof, which is to be read in connection with the accompanying drawings.
FIG. 1 is a diagram of the use of an interventional instrument for atrial septa in accordance with a preferred embodiment of the present invention;
FIGS. 2a and 2b are block diagrams of an interventional instrument for atrial septum in accordance with a preferred embodiment of the present invention;
FIGS. 3a and 3b are block diagrams of a preferred embodiment interventional instrument for atrial septum in a retracted state and in a deployed state;
figures 4a, 4b and 4c are block diagrams of a support frame of an interventional instrument for atrial septum according to a preferred embodiment of the present invention;
figures 5a and 5b are block diagrams of a variant embodiment of a support frame for an atrial septal interventional instrument according to a preferred embodiment of the present invention;
FIGS. 6a, 6b and 6c are block diagrams of an interventional instrument blood flow barrier membrane for atrial septum according to a preferred embodiment of the present invention;
figures 7a, 7b and 7c are block diagrams of a support frame of an interventional instrument for atrial septum according to a preferred embodiment of the present invention;
FIGS. 7d and 7e are block diagrams of the coupling of the interventional instrument for atrial septum in accordance with the preferred embodiment of the present invention;
fig. 8a and 8b are flow charts of a method of manufacturing an interventional device for atrial septa in accordance with a preferred embodiment of the present invention.
The reference numbers illustrate:
the support frame 100, the first support frame 1, the first passageway 10, the support arms 11, the first arc segment 111, the second arc segment region 112, the third arc segment region 113, the first distal end face 114, the first proximal end face 115, the central region 12, the peripheral region 13, the second support frame 2, the second passageway 20, the second distal end face 211, the second proximal end face 212, the mounting slot 2120, the connector 3, the first connector 41, the first end 411, the second end 412, the second connector 42, the third end 421, the fourth end 422, the first constriction 43, the second constriction 44, the access marker 45, the tubular mesh 50, the first constriction 51, the second constriction 52, the mesh 53, the blood flow barrier 6, the delivery device 200, the sheath 300, the inferior vena cava 400, the left ventricle 501, the right ventricle 502, the atrial septum 503.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.
For the sake of simplicity, only the parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".
It should be further understood that the term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.
In this context, it is to be understood that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.
Referring to fig. 1 to 8b of the specification, the interventional device for atrial septum provided by the present invention is illustrated, at least one of the first support frame and the second support frame of the interventional device is provided with a gap-shaped passage, which can form a transmembrane passage with a passage on the other support frame, and can allow a transmembrane channel to be established again through the support frames of the interventional device, and the gap-shaped passage can allow adjacent interventional devices to be staggered without overlapping adjacent interventional devices, and can allow adjacent interventional devices to be clamped and limited with each other.
Referring to the description figures 2a and 2b, in particular, the interventional instrument comprises a support frame 100, the support frame 100 having a deployed state and a collapsed state. Referring to fig. 3a of the specification, in the collapsed state, the support frame 100 is collapsed to an elongate configuration; referring to fig. 3b of the specification, in the unfolded state, the support frame 100 includes a first support frame 1, a second support frame 2, and a connecting member 3. The first support frame 1 has a notch-shaped first passage 10; the second support frame 2 has a second passage 20. The first support frame 1 and the second support frame 2 are oppositely disposed, the first passage 10 and the second passage 20 are oppositely disposed, and both ends of the connecting member 3 are respectively connected to the first support frame 1 and the second support frame 2.
It should be noted that, in the preferred embodiment, the first passage 10 and the second passage 20 are disposed opposite to each other, and it is not necessary that the first passage 10 and the second passage 20 have the same shape and are completely aligned, and a part of the first passage 10 and a part of the second passage 20 may be formed as a septum-penetrating passage. The specific shape of the first and second passages 10, 20 should not constitute a limitation of the present invention as long as a through-septum passage can be formed through the first and second passages 10, 20.
Referring to the description of fig. 1, in use, when the support frame 100 is in the collapsed state, the interventional device can be delivered by a delivery apparatus 200 along a sheath 300 in an inferior vena cava 400 to the gap between a left ventricle 501 and a right ventricle 502. The interventional device is deployed in the deployed state at the gap of the atrial septum 503, the first support frame 1 and the second support frame 2 are respectively located at the left and right sides of the atrial septum, and the connecting member 3 passes through the gap of the atrial septum, so that the gap of the atrial septum 503 can be closed.
Preferably, the shape of the second passage 20 on the second support frame 2 is also a notch shape, that is, the shape of the first passage 10 on the first support frame 1 and the shape of the second passage 20 on the second support frame 2 are both notch shapes. Alternatively, the second passage 20 can also be circular in shape. Referring to fig. 4a of the specification, the first passage 10 of the first support frame 1 has two passage forms of a notch shape and a through hole shape, and the second passage 20 of the second support frame 2 also has two passage forms of a notch shape and a through hole shape.
With reference to the description figures 2a and 2b, the first support frame 1 and/or the second support frame 2 comprise at least one support arm 11, respectively. Gaps between both sides of the support arm 11 of the first support frame 1 and adjacent portions on the first support frame 1 form the first passage 10, and gaps between both sides of the support arm 11 of the second support frame 2 and adjacent portions on the second support frame 2 form the second passage 20.
It is worth mentioning that the support arms 11, which are arranged at a distance from each other for the first support frame 1 and the second support frame 2, respectively, enable to reduce the volume of the first support frame 1 and the second support frame 2 in the contracted state for facilitating the delivery through the inferior vena cava to the interatrial septum.
Referring to fig. 4b of the specification, one end of the support arm 11 away from the center of the first support frame 1 or the center of the second support frame 2 has a first arc-shaped section 111, a third arc-shaped section 113 is arranged between two adjacent support arms 11, and the support arms 11 further have a second arc-shaped section 112 arranged between the first arc-shaped section 111 and the third arc-shaped section 113. The shape of the first arc-shaped segment 111 is matched with the shape of the third arc-shaped segment 113, and one supporting arm 11 of one interventional instrument is suitable for being clamped with the third arc-shaped segment 113 between two adjacent supporting arms 11 of the other interventional instrument.
Will support arm 11, adjacent the junction between the support arm 11 sets up to arc excessive can avoid support arm 11 causes the harm to the interatrial septum, improves the security of intervene instrument.
Preferably, the structure of the support arm 11 is substantially symmetrical. The first arc-shaped section 111, the second arc-shaped section 112 and the third arc-shaped section 113 are connected in sequence, and the first arc-shaped section 111 extends from a point a to a point B to form a radial outer edge of the support arm 11. The second arc segment 112 extends from point B to point C. The third arc segment 113 extends from point C to point D. The first arc-shaped section 111 and the second arc-shaped section 112 have the same bending direction and have a certain bending angle at the point B, and the second arc-shaped section 112 and the third arc-shaped section 113 have opposite bending directions and are tangent at the point C.
The first arc-shaped section 111 is bent outwards in a radial direction, the center of the arc approximately coincides with the center of the first support frame 1 or the second support frame 2, the center angle of the arc may be between 10 and 20 degrees, a preferred angle may be 15 degrees, and the arc length may be between 2 and 12 mm.
At point B, the first arc segment 111 turns to the second arc segment 112, and the connection angle between the first arc segment 111 and the second arc segment 112 may be between 90 ° and 160 °. Preferably, the first arc-shaped section 111 and the second arc-shaped section 112 are smoothly transited, and the preferable connection angle is not less than 100 °. The second arcuate segment 112 may have an arcuate radius of approximately 1/5 to 1/2 of the arcuate radius of the first arcuate segment 111, and a preferred ratio may be 1/3. The second arcuate segment 112 may be centered at an angle between 60 and 90, with a preferred angle being 75.
At point C, the second arcuate segment 112 turns into the third arcuate segment 113, both being approximately tangent at point C, and the third arcuate segment 113 curves radially inward, from point C to point D. The arc radius of the third arc segment 113 may be approximately 1/5-1/2 of the arc radius of the first arc segment, and the preferred ratio may be 1/4, that is, the arc radius of the third arc segment may be set to be larger than the arc radius of the second arc segment, and the center angle of the third arc segment 113 may be between 60 ° and 90 °, and the preferred angle may be 75 °.
Preferably, with reference to the description of fig. 4b and 4c, the first support frame 1 and the second support frame 2 have a central region 12 and a peripheral region 13, respectively, the central region 12 being substantially an inscribed circle inscribed in the third arc segment 113, the centre O of the inscribed circle substantially coinciding with the centre of the first support frame 1 and the second support frame 2. The first passage 10 is formed in the peripheral area 13 of the first support frame 1, and the second passage 20 is formed in the peripheral area 13 of the second support frame 2. When the support frame 100 provided by the present invention is in the deployed state and is mounted on the atrial septum, the central region of the first support frame 1 and the central region of the second support frame 2 can seal off a defect in the atrial septum, and the peripheral region of the first support frame 1 and the peripheral region of the second support frame 2 are respectively clamped on both sides of the atrial septum.
It is understood that the shape of the supporting arm 11 may be configured in any suitable shape, that is, the first supporting frame 1 and/or the second supporting frame 2 may be configured in any suitable shape, and the shape of the first supporting frame 1 and/or the second supporting frame 2 is not limited by the present invention. The dimensions of the first support frame 1 and the second support frame 2 may also be configured differently, increasing the dimensions of the first support frame 1 within a certain range may be beneficial for the stability of the interventional instrument 100, corresponding to pressure benefits for higher blood pressure in the left atrium.
Referring to fig. 5a and 5b of the specification, in a modified embodiment of the present invention, the first support frame 1 and/or the second support frame 2 are respectively composed of two support arms 11, the support frame 100 is formed by connecting the first support frame 1 and the second support frame 2 alternately, the overlapped portion of the support frames 1 and 2 forms the central area 12, the non-overlapped portion of the support frames 1 and 2 forms the peripheral area 13, and the gap between two adjacent support arms 11 forms the first passage 10 and/or the second passage 20. In such a variant embodiment, the support arm 11 has a greater freedom of adapting the shape in which the surface area of the peripheral region 13 is kept greater than the surface area of the central region 12, which is beneficial for the retention of the atrial septal tissue by the interventional instrument 100.
It is further noted that the clamping force of the first support frame 1 and the second support frame 2 when clamped to the atrial septum is at least 2N, preferably at least 6N, resistant to the impact of the heart blood flow and capable of retaining the body tissue in the defect in the atrial septum.
Preferably, with reference to the description of fig. 6a, 6b and 6c, the interventional instrument for atrial septum further comprises a blood flow barrier 6 arranged at the first passage 10 and/or the second passage 20. The interventional instrument for atrial septum further comprises access markings 45 arranged at the periphery of the first access 10 and/or the second access 20, see fig. 4b of the description.
Preferably, the blood flow barrier 6 consists of an electrospun polymeric material or a synthetic fabric. Electrospun polymeric materials such as Polylactide (PLA), polylactide glycolide (PLGA), Polycaprolactone (PLC), Polyacrylonitrile (PAN), lactide-caprolactone copolymer (PLCL), polygluconate (polyglyconate), and polypeptides. The electrospun polymer can promote cell endothelialization, has faster biodegradation time, can reduce thrombosis, is easy to puncture, and can help an interventional device to easily pass through after closing the interatrial gap and then puncture. Various synthetic fabrics may be non-degradable materials such as polyethylene terephthalate (PET), or bio-spun polyurethane.
The blood flow barrier 6 may be secured to the support frame 100 via heat staking, stitching, molding, adhesive, weaving, and any suitable method. The blood flow barrier 6 may be located inside the support frame 100 or outside the support frame 100, and may be distributed over the entire support frame 100, preferably over the metal covering of the support frame 100, i.e. the support arms 11 and the central area 12 connecting the support arms 11; in some embodiments, the blood flow barrier 6 may also be arranged only at the trans-septal pathway.
The access mark 45 is used to mark the position of the first access 10 and/or the second access 20 under fluoroscopy or ultrasound equipment, guiding the operator to quickly reach the trans-septal access position. The passage marks 45 may be arranged at the edge of the through-membrane passage, one or more in number. The material of the passage mark 45 may be a metal or alloy material or various compound coatings which are easily affected to detect, and the metal material may be medical stainless steel, palladium, iridium, tungsten, platinum, or the like, or an alloy thereof.
Referring to the description fig. 7a, 7b and 7c, in some embodiments, the side of the second support frame 2 facing the first support frame 1 is an arc-shaped face. The side surface of the second supporting frame 2 facing the first supporting frame 1 is set to be an arc-shaped surface, so that the side surface of the first supporting frame 1 facing the second supporting frame 2 can better fit with the atrial septum in the use process, and the stability of the supporting frame 100 installed in the atrial septum is improved.
With reference to fig. 7a of the description, further, the first support frame 1 has a first distal face 114 and a first proximal face 115. The support frame 100 further includes a first connection body 41. The first connecting body 41 has a first end 411 and a second end 412. The first end 411 is connected to the first distal end face 114, the second end 412 extends out of the first proximal end face 115, and the diameter of the first end 411 is larger than the diameter of the second end 412. In other words, the first connection body 411 is an inverted pyramidal structure extending from the first distal end face 114 to the first proximal end face 115. By providing the first connecting body 41 with an inverted cone shape, the first proximal end surface 115 can have a proper pulling force toward the first distal end surface 114, so that the first support frame 1 tends to approach the second support frame 2, thereby improving the stability of the installation of the first support frame 1 and the second support frame 2. In addition, the first end 411 of the first connecting body 41 can also facilitate the covering of the first support frame 1 by human tissue, so that the interventional device can be fused with the atrial septum more quickly.
It will be appreciated that in some embodiments, the first end 411 and the second end 412 of the first connecting body 41 may be otherwise disposed, such as extending outwardly of the first distal face 114 and outwardly of the first proximal face 115, respectively. The arrangement of the first connecting body 41 is not a limitation of the present invention.
Preferably, the diameter of the first end 411 is about 5% -15% of the diameter of the first support frame 1, and the distance between the first end 411 and the second end 412 of the first connection body 41 is about 1mm-3 mm.
With reference to fig. 7b of the description, the second support frame 2 has a second distal face 211 and a second proximal face 212, the second distal face 211 being disposed opposite the first proximal face 114. The support frame 100 further includes a second connector 42. The second connecting body 42 has a third end 421 and a fourth end 422, the third end 421 is connected to the second distal end surface 211, the fourth end 422 extends out of the second distal end surface 211, and the diameter of the third end 421 is larger than that of the fourth end 422. Similar to the first connecting body 41, the second connecting body 42 is also of a tapered configuration, capable of exerting a suitable pressure on the second distal end face 211, so that the second distal end face 211 has a tendency to move towards the first support frame 1, so that the first support frame 1 and the second support frame 2 better grip the atrial septum.
Preferably, the first connecting body 41 is located at the geometric center of the first support net 1, and the second connecting body 42 is located at the geometric center of the second support net 2.
Preferably, both ends of the connector 3 are connected to the first connector 41 and the second connector 42, respectively, and both ends of the connector 3 are integrally formed with the first connector 41 and the second connector 42, respectively. Referring to fig. 7d of the description, in some variant embodiments of the invention, said first connecting body 41 and said second connecting body 42 are joined to form said connecting element 3. Referring to fig. 7e of the specification, the first connecting body 41 and the second connecting body 42 are connected by a second binding structure 44.
Preferably, the connector 3 is a cylindrical body having a length of about 1-3mm and a diameter of about 1-3 mm. The connecting member 3 can also have other shapes, such as distance, but not limited to taper, etc., and the specific shape of the connecting member 3 should not be construed as limiting the invention. The number of the connecting members 3 can be one or more, and the number of the connecting members 3 should not be construed as limiting the present invention.
Referring to fig. 7b of the specification, the second proximal face 212 has a mounting slot 2120. The supporting frame 100 further includes a first binding structure 43 installed in the installation groove 2120, and the first binding structure 43 is used for connecting a conveying device.
On one hand, the first bundling structure 43 can limit the second supporting frame 2, so that the second supporting frame 2 maintains a preset shape; in another aspect, the first harvesting structure 43 can also be used in connection with an interventional delivery device by which the support frame 100 can be delivered transvascularly to the atrial septum.
Preferably, the first converging structure 43 is cylindrical, the height is 1mm-3mm, and the diameter of the bottom surface is 1mm-3 mm. The first converging structure 43 may also be spherical or any other suitable shape. The first constriction structure 43 is made of metal, and can be made of metal materials suitable for interventional instruments such as medical stainless steel and nickel-titanium alloy.
Referring to the description figures 8a and 8b, the invention further provides, according to another aspect of the invention, a method of manufacturing an interventional device for atrial septum, comprising:
301: weaving the tubular net 50 using metal wires;
302: converging a first pre-convergence part 51 of the cylindrical net 50 into a first convergence point;
303: converging a second pre-convergence part 52 of the cylindrical net into a second convergence point;
304: selecting an intermediate end closing point between the first pre-closing position 51 and the second pre-closing position 52 of the cylindrical net 50 to form an intermediate closing point;
305: approaching the first closing point and the intermediate closing point along the central axis of the cylindrical net 50 and pressing the cylindrical net 50 between the first closing point and the intermediate closing point to form a first support frame 1;
306: approaching the second closing point and the intermediate closing point along the central axis of the cylindrical net 50 and pressing the cylindrical net 50 between the second closing point and the intermediate closing point to form a second support frame 2;
307: poking a wire of a first preset point on the first support frame 1 to expand to form a first passage 10;
308: poking a second pre-set point of wire on the second support frame 2 to expand to form a second passageway 20, wherein the first passageway 10 is disposed opposite the second passageway 20 and adapted to form a trans-septal passageway.
It should be noted that the above method sequence numbers are only used for more convenient and clear illustration of the present invention, and the sequence numbers should not be construed as limiting the present invention, and the sequence of the steps can be adjusted according to the actual needs.
Preferably, in said step 301, said wire is a nitinol wire. The wires may have a diameter of 0.02mm to 0.2mm, and may be 12, 18, 24, 30, 36, 42 or 48, and after weaving, the wires form a plurality of cells 53, the angle of the cells 53 facing the proximal and distal ends is a, i.e. the angle along the axial direction is a small acute angle, preferably 30 °, and the angle is substantially set, so that the tubular mesh 50 has rows N, which are substantially the same in each row, as described in fig. 8a of the specification, and in fig. 8a of the specification. The braided net keeps a roughly cylindrical shape and is still in a relatively relaxed state, the angle can be stressed to change, and the relative position between the metal wires can be changed by stirring.
In the step 302, 304, the first beam-ending point, the second beam-ending point, or the third beam-ending point can be formed by using an annular beam-ending member or a thermal pressing manner. It is to be understood that the specific formation manner of the first beam-ending point, the second beam-ending point and the third beam-ending point should not be construed as limiting the present invention.
The step 307: toggling a wire of a first preset point on the first support frame to expand to form a first pathway, comprising:
3071: the first preset point is located in the peripheral area of the first support frame 1, and the metal wire of the first preset point is pushed to form the first through hole-shaped passage 10.
The step 308: toggling a wire of a second preset point on the second support frame to expand to form a second pathway, comprising:
3081: the second preset point is located in the peripheral area of the second support frame 2, and the wire of the second preset point is pushed to form the second through-hole-shaped passage 20.
Further, in the step 3071: after the wire of the first preset point is pulled to form the first through-hole-shaped passage 10, the method comprises the following steps:
3072: the first pre-collecting point on the outer edge of the first support frame 1 is shifted to move towards the center direction, so that the inner side edge of the first through hole-shaped passage 10 is folded and connected, and the first through hole-shaped passage 10 is formed in a notch shape outside the first pre-collecting point.
Further, in the step 3081: after the wire at the second preset point is pulled to form the second through-hole-shaped passage 20, the method comprises the following steps:
3082: and shifting a second pre-collecting point at the outer edge of the second support frame 2 to move towards the center direction, so that the inner side edge of the through-hole-shaped second passage 20 is folded and connected, and the second passage 20 in a notch shape is formed outside the second pre-collecting point.
In step 3072 and step 3082, the first through-hole-shaped passage 10 and the second through-hole-shaped passage 20 are formed first, and then the first through-hole-shaped passage 10 and the second through-hole-shaped passage 20 are connected by pressing to form the first notched-shaped passage 10 and the second notched-shaped passage 20, so that the stability of the structures of the first notched-shaped passage 10 and the second notched-shaped passage 20 can be improved.
Referring to fig. 8b of the specification, alternatively, in a modified embodiment of the present invention, the first support frame 1 and the second support frame 2 can be directly pressed to form the first passage 10 and the second passage 20 in a notch shape. Such as: in said step 307: poking the wire of a first preset point on the first support frame 1 to expand to form a first pathway, comprising: the first pre-collecting point of the outer edge of the first supporting frame 1 is shifted to move towards the center, so that the first passage 10 in a notch shape is formed outside the first pre-collecting point. In said step 308: plucking the wire of a second preset point on said second support frame 2 to expand to form a second passage 20, comprising: the second pre-collecting point of the outer edge of the second supporting frame 2 is shifted to move towards the center, so that the second passage 20 in a notch shape is formed outside the second pre-collecting point.
Further, the manufacturing method of the interventional instrument for atrial septum further comprises:
309: the passage mark 45 is provided on a predetermined wire of the cylindrical net 50.
Preferably, the passage mark 45 is a ring-shaped metal mounted on the wire, and the step 309 may be performed after the step 309, after the steps 307 and 308, and the shifted wire can be fixed by the ring-shaped passage mark 45 after the wire is shifted in the steps 307 and 308.
Further, in the step 302, 304, preferably, a first end and a second end of the two ends of the cylindrical net 50 respectively form the first pre-collecting part 51 and the second pre-collecting part 52, the first end and the second end of the cylindrical net 50 respectively form the first beam-collecting point and the second beam-collecting point, and the middle end is the middle part of the cylindrical net 50.
In some modified embodiments of the present invention, the cylindrical net 50 is folded before the cylindrical net 50 is bundled and pressed, and after the first end of the cylindrical net 50 is folded inwards or outwards along the axis of the cylindrical net by a preset distance, the first end and the corresponding cylindrical net 50 are bundled to form the intermediate bundling point; a second end of the cylindrical net 50 is converged to form a second convergence point; and the overlapped ends of the rolled cylindrical net are bunched to form a first beam-collecting point.
Illustratively, 20 of the mesh rows N are selected, the cylindrical mesh 50 is folded inwards or outwards at a position of 1/4 in the axial direction approximately, a first end of the cylindrical mesh 50 is located at a position of 1/3 in the axial direction approximately after being folded, and metal is respectively gathered at a position of 1/3 after being folded and the other end of the original cylindrical mesh 50, and the metal can be gathered in a manner of gathering pieces or thermal pressing and the like; applying reverse acting force at the approximate 1/3 position after being folded and two ends of a new end point formed after being folded, and compressing the net to be approximately a plane net; applying a counter force between the folded approximately 1/3 position and the other end of the original tubular net 50, compressing the net to an approximately flat net.
In other examples, 30 grid rows N are selected, the tubular net 50 is folded inwards or outwards at a position approximately corresponding to the axial center line, two ends of the original tubular net are approximately overlapped, and metal is respectively collected at approximately 1/3 positions after being folded and two ends approximately overlapped with the original tubular net 50, and the metal can be collected by using a collecting piece or thermal pressing and the like; applying reverse acting force at the approximate 1/3 position after being folded and two ends of a new end point formed after being folded, and compressing the net to be approximately a plane net; the folded web is compressed to a substantially flat web by applying opposing forces at the two ends of the web at a location approximately 1/3 which is approximately coincident with the original web 50.
With reference to the description of fig. 8a and 8b, on said approximately planar meshes, the axial angle a of said meshes 53 is transformed into a radial angle β facing towards the centre and towards the outer edge, the metallic materials being close to each other in said central zone 12, said radial angle β being smaller, the first of said rows N being close to the centre, said radial angle β being set at 5 ° to 15 °, starting from the second of said rows N being close to the centre, said radial angle β being restored to about 30 °, said meshes 53 being close to the edges, said radial angle β possibly being larger, the maximum angle being not greater than 150 °.
It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that it is obvious to those skilled in the art that various modifications and improvements can be made without departing from the principle of the present invention, and these modifications and improvements should also be considered as the protection scope of the present invention.
Claims (14)
1. A method of manufacturing an interventional device for atrial septa comprising:
weaving a cylindrical net by using metal wires;
forming a first beam-collecting point on a first pre-beam-collecting position of the cylindrical net;
forming a second beam-collecting point on a second pre-collecting position of the cylindrical net;
selecting an intermediate end between the first pre-receiving position and the second pre-receiving position of the cylindrical net to form an intermediate beam-closing point;
the first closing point and the middle closing point are close to each other along the central axis of the cylindrical net, and the cylindrical net between the first closing point and the middle closing point is pressed to form a first supporting frame;
the second closing point and the middle closing point are close to each other along the central axis of the cylindrical net, and the cylindrical net between the second closing point and the middle closing point is pressed to form a second supporting frame;
poking a wire of a first preset point on the first support frame to expand to form a first passage;
poking a second pre-set point of wire on the second support frame to expand to form a second passageway, wherein the first passageway is disposed opposite the second passageway and adapted to form a trans-septal passageway.
2. The method of claim 1, wherein toggling the wire of the first preset point on the first support frame to expand to form the first passageway comprises: the first preset point is positioned in the peripheral area of the first support frame, and the metal wire of the first preset point is stirred to form the first through hole-shaped passage;
toggling a wire of a second preset point on the second support frame to expand to form a second pathway, comprising: the second preset point is located in the peripheral area of the second support frame, and the metal wire of the second preset point is pushed to form the second through hole-shaped passage.
3. The method of claim 2, wherein poking the wire at the first pre-set point to form the first passageway in a through-hole shape comprises: pushing the outer edge of the first support frame to move towards the center direction at a first preset point, so that the inner side edge of the first through hole-shaped passage is folded and connected, and the first through hole-shaped passage is formed at the first preset point;
poking the wire at the second preset point to form the second through hole-shaped passage, and then: and pushing the outer edge of the second supporting frame to move towards the center direction at a second preset point, so that the inner side edge of the second channel in the through hole shape is folded and connected, and a notch-shaped second channel is formed at the second preset point.
4. The method of claim 1, wherein toggling the wire of the first preset point on the first support frame to expand to form a first pathway comprises: pushing the outer edge of the first support frame to move towards the center direction at a first preset point so as to form the first passage in a notch shape at the first preset point;
toggling a wire of a second preset point on the second support frame to expand to form a second pathway, comprising: and pushing the outer edge of the second support frame to move towards the center direction at a second preset point so as to form the second passage in a notch shape at the second preset point.
5. The method of manufacturing an interventional instrument for atrial septum of any one of claims 1-4, further comprising: and arranging a passage mark on the preset metal wire of the cylindrical net.
6. The method of manufacturing an interventional instrument for atrial septa as recited in any one of claims 1-4, wherein:
the first end and the second end of the two ends of the cylindrical net respectively form the first pre-receiving position and the second pre-receiving position correspondingly; or:
the first end of the cylindrical net is folded inwards or outwards along the axis of the cylindrical net by a preset distance, and then the first end and the corresponding cylindrical net are bunched to form the middle bunching point; a second end of the cylindrical net is converged to form a second beam converging point; and the overlapped ends of the rolled cylindrical net are bunched to form a first beam-collecting point.
7. An interventional instrument for atrial septum comprising a support frame having an expanded state and a collapsed state; in the collapsed state, the support frame is collapsed into an elongate configuration; in the deployed state, the support frame comprises:
a first support frame having a notch-shaped first passage;
a second support frame having a second passage;
the first support frame and the second support frame are arranged oppositely, the first passage and the second passage are arranged oppositely, and two ends of the connecting piece are connected to the first support frame and the second support frame respectively.
8. The interventional instrument for atrial septum of claim 7, wherein the first support frame and the second support frame each include at least two support arms, adjacent two of the support arms of the first support frame forming the first passageway and adjacent two of the support arms of the second support frame forming the second passageway.
9. The interventional instrument for atrial septum of claim 8, wherein an end of the support arm distal from a center of the first support frame or a center of the second support frame has a first arc segment, a third arc segment between two adjacent support arms, the support arm further having a second arc segment between the first arc segment and the third arc segment; the shape of the first arc-shaped section is matched with that of the third arc-shaped section, and one supporting arm of one interventional instrument is suitable for being clamped with the third arc-shaped section between two adjacent supporting arms of the other interventional instrument.
10. The interventional instrument for atrial septum of any one of claims 7-9, wherein the interventional instrument for atrial septum further comprises a blood flow barrier disposed at the first passageway and/or the second passageway;
the interventional instrument for atrial septum further comprises access indicia disposed about the first access and/or the second access.
11. The interventional instrument for atrial septum of any one of claims 7-9, wherein a side of the first support frame facing the second support frame is an arcuate face;
and/or the side of the second support frame facing the first support frame is an arc-shaped surface.
12. The interventional instrument for atrial septum of claim 11, wherein the first support frame has a first distal end face and a first proximal end face;
the support frame further includes a first connector having a first end connected to the first distal face and a second end extending beyond the first proximal face, and the first end has a diameter greater than a diameter of the second end.
13. The interventional instrument for atrial septum of claim 2, wherein the second support frame has a second distal end face and a second proximal end face, the second distal end face being disposed opposite the first proximal end face;
the support frame further includes a second connector having a third end connected to the second proximal end face and a fourth end extending beyond the second distal end face, and the third end has a diameter greater than the fourth end.
14. The interventional device for atrial septum of claim 13, wherein the second proximal face has a mounting slot, the support frame further comprising a first constriction mounted in the mounting slot, the first constriction providing for a delivery device.
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| CN202110901860.2A CN113616256B (en) | 2021-08-06 | 2021-08-06 | Interventional instrument for atrial septum and method of manufacture |
| CN202310915275.7A CN116919485A (en) | 2021-08-06 | 2021-08-06 | Interventional instrument for atrial septum and method of manufacture |
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| CN202110901860.2A CN113616256B (en) | 2021-08-06 | 2021-08-06 | Interventional instrument for atrial septum and method of manufacture |
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| CN215349158U (en) * | 2021-08-06 | 2021-12-31 | 上海普实医疗器械股份有限公司 | Interventional device for sealing atrial septum |
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| CN116919485A (en) | 2023-10-24 |
| CN113616256B (en) | 2023-08-18 |
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