CN114767180A - Atrial septal defect plugging device - Google Patents
Atrial septal defect plugging device Download PDFInfo
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- CN114767180A CN114767180A CN202210371785.8A CN202210371785A CN114767180A CN 114767180 A CN114767180 A CN 114767180A CN 202210371785 A CN202210371785 A CN 202210371785A CN 114767180 A CN114767180 A CN 114767180A
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- atrial septal
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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
- A61B17/0057—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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B2017/00597—Implements comprising a membrane
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Abstract
The invention relates to an atrial septal defect occluder, which comprises an elastic woven net rack and a flexible connecting piece, wherein the elastic woven net rack comprises a left disk surface and a right disk surface; the flexible connecting piece comprises a hollow cylindrical waist structure made of flexible connecting sheets, and two ends of the flexible connecting piece are respectively connected with the near end of the left disc surface and the far end of the right disc surface; the flexible connecting sheet is made of a high polymer material with good biocompatibility and elasticity so as to adapt to atrial septal defects of different anatomical forms, improve the plugging effect and ensure that no long-term residual shunt is generated; meanwhile, the metal dosage is reduced, and the harm of metal ion release to human bodies is reduced.
Description
Technical Field
The invention relates to the field of medical instruments for interventional operation, in particular to an atrial septal defect occluder.
Background
Atrial Septal Defect (ASD) is a congenital heart malformation which is common in clinic, is mainly formed in the production and development process of fetuses, and is influenced by certain factors, so that the atrial septal defect of the heart is abnormal in the embryonic development process, and a gap is left between the left atrium and the right atrium. In the case of atrial septal defects, since the pressure in the left atrium is higher than that in the right atrium, blood generally flows from the left atrium into the right atrium through the septal defect, resulting in an increase in the volume of blood in the right atrium, leading to hypertrophy of the right ventricle and an increase in the amount of circulating blood in the lungs. The long-term presence of atrial septal defects may lead to Pulmonary Hypertension (PAH), Congestive Heart Failure (CHF), Arrhythmia (Arrhythmia), Stroke (Stroke), Dizziness (Dizziness), Syncope (Syncope), and other conditions.
At present, the most widely used occluder represented by Amplatzer for clinically treating atrial septal defect comprises an integrated left disc surface, an integrated right disc surface and a waist connecting piece. The left disc surface, the right disc surface and the waist connecting piece of the plugging device are all in rigid connection to form an integral structure. The principle is that an occluder with elastic characteristics is compressed into a structure with smaller size, the structure is conveyed to a defect position through a catheter, an elastic occluder apparatus automatically expands to restore to a preset shape, a left disc surface and a right disc surface are respectively clung to atrial walls on two sides of an atrial septum, and the left disc surface and the right disc surface clamp the edge of the atrial septum defect together.
However, when this type of atrial septal defect occluder is pushed out of a delivery device and released, the distance and relative angle between the left and right discoid surfaces cannot be adjusted relatively. In actual clinical operation, because of the existence of individual difference of patients, the atrial septal defect corresponding to the patient has different thickness and inclination, therefore, the current occluder can not adapt to atrial septal defects of different anatomical forms, and the occlusion effect is not good.
Based on the above reasons, how to improve the structure of the atrial septal defect occluder, so that it can adapt to atrial septal defects of different anatomical forms, and improve the occlusion effect, has become a technical problem which needs to be solved urgently at present.
Disclosure of Invention
The invention discloses an atrial septal defect occluder, which aims to solve the technical problems in the prior art.
The invention adopts the following technical scheme:
an atrial septal defect occluder comprising:
-an elastically woven net frame comprising a left panel and a right panel;
-a flexible connection member comprising a hollow cylindrical waist structure made of a flexible connection sheet, both ends of the flexible connection member being connected to the proximal end of the left disc face and the distal end of the right disc face, respectively; the flexible connecting sheet is made of high polymer materials with good biocompatibility.
As a preferred technical scheme, the outer wall of the flexible connecting sheet is coated with a hydrophilic expansion material, and the hydrophilic expansion material can absorb liquid and expand after contacting with blood.
Preferably, the hydrophilic swelling material comprises a medical hyaluronic acid material.
As a preferred technical scheme, the flexible connecting piece also comprises a plurality of elastic elements, and two ends of each elastic element are respectively connected with the near end of the left disc surface and the far end of the right disc surface; the flexible connecting sheet is of a double-layer structure, and the elastic element is arranged in a gap of the double-layer flexible connecting sheet.
Preferably, the elastic element includes a retractable spring or an elastic body made of a polymer elastic material.
As a preferred technical scheme, the axial length of the flexible connecting sheet in a flat state is greater than that of the elastic element in a natural state; the flexible connecting sheet material has a continuous fold structure in the axial direction, and the axial length of the flexible connecting sheet material in a fold state is the same as the axial length of the elastic element in a natural state.
As the preferred technical scheme, the near end of the right disc surface is connected with a fastening piece, and the fastening piece is provided with a hollow channel; and a locking mechanism is arranged on the flexible connecting piece, one end of the locking mechanism is connected with the flexible connecting sheet, and the other end of the locking mechanism penetrates through the hollow channel of the fastener.
Preferably, the fastener comprises a steel sleeve.
As a preferred technical solution, the locking mechanism comprises a plurality of pulling wires and locking elements; one end of each traction wire is fixed on the inner side of the flexible connecting sheet in a radial shape, and the other ends of the traction wires are gathered together and connected with the locking element; the locking element includes structure that irreversibly enters the hollow passage of the fastener and completes the lock.
Preferably, the locking element comprises a locking knot, a locking ball or a locking table.
Preferably, there are at least two locking elements.
As a preferred technical scheme, the flexible connecting sheet is made of a material with flow resistance.
As a preferred technical scheme, one side of the left disc surface facing the left atrium and/or one side of the right disc surface facing the right atrium is a flat plane.
As the preferred technical scheme, at least one puncture hole is correspondingly arranged on the left disk surface and the right disk surface, and the size of the puncture hole is larger than the mesh size of the elastic woven net rack.
As a preferred technical scheme, the device also comprises a flow resistance film, wherein the flow resistance film comprises: the left disk flow-resisting film is arranged on the left disk surface, and the right disk flow-resisting film is arranged on the right disk surface.
As a preferred technical scheme, the flow resisting film is made of biodegradable materials.
The technical scheme adopted by the invention can achieve the following beneficial effects:
(1) the invention provides an atrial septal defect occluder, which comprises a left disc surface and a right disc surface which are woven by elastic metal wires, wherein a waist structure formed by a woven net rack is cancelled between the left disc surface and the right disc surface, and the left disc surface and the right disc surface are connected by flexible connecting pieces instead, wherein the flexible connecting pieces can be made of materials with better biocompatibility and elasticity so as to adapt to atrial septal defects with different anatomical forms, improve the occlusion effect and ensure that no long-term residual shunt is generated; meanwhile, the metal dosage is reduced, and the harm of metal ion release to human bodies is reduced.
(2) In order to adapt to the shapes of various atrial septal defects, the outer wall of the flexible connecting element is coated with a coating made of a hydrophilic expansion material, and after the flexible connecting element is implanted into a defect, the hydrophilic expansion material is contacted with blood to absorb liquid and expand along with the prolonging of time so as to adapt to atrial septal defect holes in different shapes, ensure the sufficient filling and fitting of the waist and the defect hole of the occluder and further prevent the occurrence of residual shunt.
(3) Above-mentioned flexible connection element is preferred double-layer membrane structure, still gomphosis elastic element in the middle of the double-layer structure, membrane structure can be the flexonics sheet, elastic element can be the elastomer of scalable spring or the preparation of polymer elastic material, form the structure of similar "sandwich", make the occluder when implanting the atrial septal defect, because the flexonics sheet can be stretched and kick-back, consequently, the operator can be according to the concrete anatomical morphology at defect position, adjust the relative angle between left quotation and the right quotation in a flexible way, make the occluder match better with the physiology anatomical structure at defect position, guarantee the shutoff effect. Meanwhile, due to the arrangement of the elastic element, the relative distance between the left disc surface and the right disc surface of the occluder can be adjusted within a certain range, and the occluder can be suitable for different patients of more types on the basis of ensuring the clamping force between the left disc surface and the right disc surface.
(4) The flexible connecting sheet of flexible connecting elements preferably forms a series of pleats in the axial direction to provide space for stretching of the flexible connecting sheet to facilitate further adjustment of the relative distance and angle between the left and right panel faces.
(5) In the plugging device, a fastener is preferably arranged at the near end of the right disc surface, a locking mechanism is arranged in the flexible connecting piece, the locking mechanism further comprises a traction wire and a locking element, one end of the traction wire is in a radial shape and is connected with the inner wall of the flexible connecting piece, and the other end of the traction wire is gathered together and is connected with the locking element; the locking element is capable of irreversibly entering the fastener internal passage and completing the locking; when a doctor performs operation, the axial length of the flexible connecting piece can be adjusted according to the actual form of atrial septal defect so as to adapt to the actual plugging requirement and ensure good plugging effect.
(6) And preferably, flow blocking films are arranged in the left disc surface and the right disc surface of the plugging device, the flexible connecting sheets for forming the flexible connecting pieces are also made of materials with flow blocking performance, and after the locking mechanism locks the form of the flexible connecting pieces, the flexible connecting sheets are integrally gathered at the central part so as to further enhance the flow blocking effect of the plugging device.
(7) In a preferred embodiment, the left and right disc surfaces of the occlusion device, especially the left disc surface corresponding to the left atrium, can be set to be a flat plane, which is beneficial to accelerating endothelialization process and reducing the risk of cerebral apoplexy caused by thrombus.
(8) In a preferred embodiment, a plurality of puncture holes are correspondingly formed in the left disc surface and the right disc surface of the occluder, the puncture holes are suitable for being used for interventional operation puncture in the future, the flow blocking films in the left disc surface and the right disc surface are made of biodegradable materials and cover the puncture holes, and after the occluder is implanted into human body endothelium, the flow blocking films gradually descend and desorb, so that puncture atrial septal puncture is conveniently carried out.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:
FIG. 1 is a schematic structural view of an atrial septal defect occluder disclosed in a preferred embodiment of example 1 of the present invention;
FIG. 2 is a schematic structural view of an atrial septal defect occluder disclosed in another preferred embodiment of example 1 of the present invention;
FIG. 3 is a schematic view showing the construction of a flexible connection unit disclosed in a preferred embodiment of example 2 of the present invention;
FIG. 4 is a schematic structural view of a flexible connection unit disclosed in another preferred embodiment of example 2 of the present invention;
FIG. 5 is a perspective view of a flexible connection unit disclosed in a preferred embodiment of example 2 of the present invention;
FIG. 6 is a schematic structural view of an atrial septal defect occluder disclosed in a preferred embodiment of example 3 of the present invention;
fig. 7 is a schematic structural view of an atrial septal defect occluder disclosed in another preferred embodiment of example 3 of the present invention.
Description of reference numerals:
the flexible connecting piece comprises a right disc surface 1, a left disc surface 2, a rivet head 3, a flexible connecting piece 4, a flexible connecting sheet 41, an elastic body 42', a telescopic spring 42, a traction wire 5, a locking element 6 and a fastener 7.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified 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; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art. The structures, the proportions, the sizes, and the like shown in the drawings attached to the present specification are only used for matching with the disclosure of the present specification, so as to be understood and read by those skilled in the art, and are not used for limiting the conditions under which the present invention can be implemented, so that the present invention has no technical essence, and any structural modification, changes of the proportion relation, or adjustment of the size, should fall within the scope of the technical disclosure of the present invention without affecting the efficacy and the achievable purpose of the present invention. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are used for clarity of description, and are not intended to limit the scope of the present invention.
It is to be understood that the disclosed embodiments are merely exemplary of the invention, and are not intended to be exhaustive or exhaustive. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
In order to solve the problems in the prior art, the embodiment of the application provides an atrial septal defect occluder which comprises an elastic woven net rack and a flexible connecting piece, wherein the elastic woven net rack comprises a left disc surface and a right disc surface; the flexible connecting piece comprises a hollow cylindrical waist structure made of flexible connecting sheets, and two ends of the flexible connecting piece are respectively connected with the near end of the left disc surface and the far end of the right disc surface; the flexible connecting sheet is made of high polymer materials with good biocompatibility.
Example 1
This embodiment 1 provides an atrial septal defect occluder, can carry out nimble distance and the angle of adjusting between left quotation 2 and the right quotation 1 after implanting the human body to guarantee that the occluder can be applicable to the atrial septal defect of various different anatomical form, provide the shutoff effect, guarantee not to produce the remaining reposition of redundant personnel of long-term.
Referring to fig. 1-2, the atrial septal defect occluder comprises an elastic woven net rack and a flexible connecting piece 4, wherein the elastic woven net rack comprises a left disc surface 2 and a right disc surface 1 which are respectively positioned in the left atrium and the right atrium after the occluder is implanted into a human body; the flexible connecting piece 4 is a hollow cylindrical waist structure, two ends of the flexible connecting piece are respectively connected with the near end of the left disc surface 2 and the far end of the right disc surface 1, and the flexible connecting piece 4 is positioned in a hole of the atrial septal defect.
Preferably, the flexible connecting piece 4 is made of a flexible connecting sheet 41, the flexible connecting sheet 41 can be made of a high polymer material with good biocompatibility, and a certain elastic modulus is ensured while supporting force is provided, so that the angle and the distance between the left disc surface 2 and the right disc surface 1 can be adjusted and changed according to the actual form adaptability of atrial septal defect; optionally, the polymer material with good biocompatibility is one or a mixture of more than two of recombinant peptide, chemically synthesized peptide, recombinant gelatin, chemically synthesized gelatin, polycaprolactone, polylactic acid, polyurethane, polyglycolic acid, polyhexamethylene propionamide, polylactic acid-glycolic acid copolymer, collagen, silk protein, cellulose and chitosan.
Preferably, the flexible connecting member 4 is connected to the elastic woven wire frame by means of biocompatible glue bonding, hot melting, sewing or laser welding.
Preferably, the outer wall of the flexible connecting piece 4 is coated with a coating made of a hydrophilic expansion material, and after the flexible connecting piece is implanted into a defect, the hydrophilic expansion material is contacted with blood to absorb liquid and expand along with the prolonging of time, so that the atrial septal defect holes in different shapes can be self-adapted, the waist of the occluder is fully filled and attached to the defect holes, and further residual shunt is prevented. The hydrophilic swelling material is preferably a hyaluronic acid material.
The left plate surface 2 and the right plate surface 1 are formed by mutually and crossly weaving a plurality of elastic metal wires with memory function, preferably nickel-titanium alloy metal wires; during production, a plurality of nickel-titanium wires are respectively crossed and woven in two directions to form two cylindrical net pipes, the two cylindrical net pipes are shaped into two disc-shaped or umbrella-shaped structures at a certain temperature, and then two ends of the flexible connecting piece 4 are respectively connected with the two cylindrical net pipes; after the elastic woven net rack is implanted into a human body and unfolded, the left disc surface 2 is positioned in the left atrium, the right disc surface 1 is positioned in the right atrium, the left disc surface and the right disc surface together clamp the atrial septal defect, and the flexible connecting piece 4 connecting the left disc surface 2 and the right disc surface 1 is positioned in the atrial septal defect.
As shown in fig. 2, preferably, the left and right disc surfaces 1 of the occluder, especially the left disc surface 2 corresponding to the left atrium, are arranged to be a flat plane, which is beneficial to increase the contact area with the atrial septal wall, so as to accelerate the endothelialization process and reduce the risk of cerebral apoplexy caused by thrombus. Optionally, because the patient has different ages, sexes, heights, weights, atrial septal defect positions and defect shapes, etc., in order to adapt to atrial septal defects of different shapes/sizes and better exert the function, the sizes of the left disc surface 2, the right disc surface 1 and the flexible connecting piece 4 can be adjusted or selected adaptively, which is not described again.
As shown in fig. 1, preferably, after the elastic mesh grid is woven, the elastic metal wires are gathered at the center positions of the far end of the left plate surface 2 and the near end of the right plate surface 1 respectively, so that the far end of the left plate surface 2 and the near end of the right plate surface 1 are both connected with a rivet head 3, the rivet head 3 is used for fixing the elastic metal wires, and meanwhile, the rivet head can be connected with a pushing device of the occluder and used for pushing the occluder from a delivery catheter to the atrial septal defect and releasing the occluder.
Preferably, a left disc flow-resisting film and a right disc flow-resisting film are respectively arranged in the left disc surface 2 and the right disc surface 1, the left disc flow-resisting film and the right disc flow-resisting film are respectively cut into sizes matched with the left disc surface 2 and the right disc surface 1, and are sewn at corresponding positions of the left disc surface 2 and the right disc surface 1 through suture lines for blocking blood flow at the atrial septal defect; optionally, the flow-resistant film is composed of polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polyamide, polyanhydride, polyphosphate, polyurethane or polycarbonate, or a copolymer of at least two of the above polymer monomers.
Preferably, the flexible connecting piece 4 is also provided with a flow blocking film in the middle in the axial direction, if the left disc surface 2 and the right disc surface 1 cannot fit with the atrial septum under certain conditions and present a dumbbell-shaped shape, the blood flowing into the interior of the occluder through the woven meshes of the left disc surface 2 can be completely blocked by the flow blocking film, so as to prevent residual shunt.
Example 2
Referring to fig. 3-5, this embodiment provides a preferred construction of an atrial septal defect occluder.
The atrial septal defect occluder comprises an elastic woven net rack and a flexible connecting piece 4, the elastic woven net rack comprises a left disc surface 2 and a right disc surface 1, the specific structure of the elastic woven net rack is the same as that in the embodiment 1, and the flexible connecting piece 4 comprises a flexible connecting sheet 41 and a plurality of elastic elements.
In a preferred embodiment, the flexible connecting member 4 comprises a double-layer flexible connecting sheet 41 and an elastic element arranged between the double-layer flexible connecting sheet 41, preferably, the flexible connecting sheet 41 in the present embodiment is made of the same material as that used in the above-mentioned embodiment 1; optionally, the elastic element is a retractable spring 42 or an elastic body 42' made of a high polymer elastic material; preferably, the polymer elastic material is made of at least one of natural rubber, nitrile rubber, polyurethane elastomer, silica gel and vinyl resin, preferably, the elastomer 42 'is in a flat strip shape and is clamped between the double-layer flexible connecting sheets 41, and two ends of the elastomer 42' are respectively connected with the near end of the left disc surface 2 and the far end of the right disc surface 1; more preferably, the elastic element is a flat retractable spring 42, and two ends of each retractable spring 42 are respectively connected to the proximal end of the left disc surface 2 and the distal end of the right disc surface 1, and the retractable spring 42 has better mechanical strength and can provide better stability after being implanted into the heart compared with an elastic body 42' made of a high polymer elastic material.
As shown in fig. 5, in the above embodiment, the double-layered flexible connecting sheet 41 and the elastic element disposed in the middle of the double-layered flexible connecting sheet 41 form a sandwich-like structure, so that when the occluder is implanted into an atrial septal defect, since the flexible connecting sheet 41 can be stretched and rebounded, an operator can flexibly adjust the relative angle between the left disc surface 2 and the right disc surface 1 according to the specific anatomical shape of the defect, so that the occluder can better match with the physiological anatomical structure of the defect, and the occlusion effect can be ensured. Simultaneously, because elastic element's setting, the relative distance between occluder left side quotation 2 and the right quotation 1 also can be adjusted at certain within range, on the basis of the clamping force of guaranteeing between left quotation 2 and the right quotation 1, can also make the occluder can be applicable to the different patients of more types.
In a more preferred embodiment, the axial length of the flexible connecting sheet 41 in the flat state is greater than the axial length of the elastic element in the natural state without stretching, when the flexible connecting member 4 is produced, the elastic element is installed and connected with the flexible connecting sheet 41 in the stretched state, and after the installation is completed, the flexible connecting sheet 41 is shrunk in the axial direction to form a series of folded structures, and the folded structures can provide space for stretching of the flexible connecting sheet 41 and facilitate adjustment of the relative distance between the left disc and the right disc.
Preferably, the outer wall of the outer flexible connecting sheet 41 is further coated with a coating layer made of hydrophilic swelling material, preferably hyaluronic acid material, which can absorb moisture in blood and swell, so as to facilitate the outer flexible connecting sheet 41 to be fully filled in the gap of the atrial septal defect.
Example 3
Referring to fig. 6-7, this embodiment provides a preferred construction of an atrial septal defect occluder.
The atrial septal defect occluder comprises an elastic woven net rack and a flexible connecting piece 4, the elastic woven net rack comprises a left disc surface 2 and a right disc surface 1, the specific structures of the left disc surface and the right disc surface are the same as those of the embodiment 1, the flexible connecting piece 4 comprises a flexible connecting sheet 41, and the structure and the material of the flexible connecting sheet are the same as those of the embodiment 1.
In a preferred embodiment, a fastener 7 is provided at the proximal end of the right panel face 1 and a locking mechanism is provided inside the flexible connector 4. Preferably, the fastener 7 is a cylindrical steel sleeve, and the structure of the fastener can be the same as that of the rivet head 3 in the embodiment 1; preferably, the locking mechanism comprises a plurality of pull wires 5 and a locking element 6 arranged at one end of the pull wires 5, wherein the locking element 6 is arranged in the hollow channel of the fastener 7 in a penetrating way.
Preferably, the plurality of traction wires 5 are radially fixed on the inner wall of the flexible connecting piece 4, and can be fixed with the flexible connecting piece 4 in a manner of adhesion by biocompatible glue, hot melting, sewing or laser welding; alternatively, several pull wires 5 are simultaneously fixed to the distal end of the flexible joint member 4, as shown in fig. 6; optionally, several pull wires 5 are fixed at the middle position of the flexible connecting element 4, as shown in fig. 7; preferably, every traction wire 5 is fixed in the different positions of flexible connectors 4 respectively to the completion is to the regulation of the more angles of flexible connectors 4, makes left quotation 2 and right quotation 1 can adjust according to the defective actual shape of atrial septal defect.
Preferably, the locking element 6 comprises a structure which can enter into the hollow channel of the fastener 7 irreversibly and can complete the locking of the traction wire 5, alternatively, the locking element 6 can be provided as a locking knot, a locking ball or a locking table, as shown in fig. 6 and 7, wherein an embodiment of the locking element 6 is provided, namely as a locking ball structure, for limiting and fixing the traction wire 5. The locking element 6 can be provided in plurality, which facilitates the adjustment of the axial length of the flexible connecting sheet 41 to suit the plugging requirement.
In a preferred embodiment, the flexible connecting sheet 41 is made of a material having a flow-resisting property, and when the flexible connecting sheet 41 is locked by the locking mechanism, the whole flexible connecting sheet 41 converges toward the central portion, thereby further enhancing the flow-resisting effect of the occluder.
In the embodiment, when a doctor performs an operation, the length of each traction wire 5 is adjusted through the locking element 6, and the axial length of the flexible connecting part 4 can be adjusted according to the actual form of atrial septal defect so as to adapt to the actual plugging requirement and ensure a good plugging effect.
Example 4
Referring to fig. 3-7, this embodiment provides a preferred construction of an atrial septal defect occluder.
The atrial septal defect occluder includes an elastic woven net frame, a flexible connecting member 4, a locking mechanism and a fastener 7, wherein the elastic woven net frame, the locking mechanism and the fastener 7 have the same structure as in example 3, and the flexible connecting member 4 has the same structure as in example 2, i.e., structure 1.
In a preferred embodiment, the elastic woven net rack comprises a left plate surface 2 and a right plate surface 1, the flexible connecting piece 4 comprises a double-layer flexible connecting sheet 41 and an elastic element, a plurality of traction wires 5 are fixed on the inner layer flexible connecting sheet, the other ends of the traction wires 5 are gathered and connected to a locking element 6, and the locking element 6 is arranged in the hollow channel of the fastener 7 in a penetrating way.
In this embodiment, the operation method and the working procedure of the atrial septal defect occluder are as follows:
when the atrial septal defect occluder is used, firstly, a push rod is connected with a fastener 7, a push handle can push the push rod forwards, so that the atrial septal defect occluder is pushed to an atrial septal defect of a patient from a conveying catheter, at the moment, the occluder is released from the conveying catheter, the left disk surface 2 is released and fixed on the left atrium, the flexible connecting piece 4 is positioned at the atrial septal defect, finally, the right disk surface 1 is released and fixed on the right atrium, after the position of the occluder is anchored, the length of each traction wire 5 is adjusted through an adjusting mechanism connected with a locking element 6, the axial length of the flexible connecting piece 4 is adjusted according to the actual wall thickness of the atrial septal defect to adapt to the requirements of occlusion, and after the adjustment is finished, the push rod is screwed to be separated from the fastener 7, so that the push rod is separated from the occluder.
The outer wall of the flexible connecting piece 4 of the occluder anchored at the atrial septal defect is coated with a hydrophilic expansion material, so that the occluder can absorb moisture in blood to expand, and the flexible connecting piece 4 is better fitted and adapted with the shape of the defect to prevent residual shunt.
Example 5
This embodiment provides a preferable structure of the atrial septal defect occluder, and this embodiment further changes the structure of the elastic woven net rack on the basis of the structure of any of the above-mentioned embodiments 1-4.
Preferably, at least one puncture hole is correspondingly formed in the left tray surface 2 and the right tray surface 1, preferably, the size of the puncture hole is larger than the mesh size of the elastic woven net rack, and more preferably, the size of the puncture hole is suitable for puncture in an interventional operation in the future.
The flow resisting films in the left disc surface 2 and the right disc surface 1 are made of biodegradable materials and cover the puncture hole, and after the plugging device is implanted into the human body to be endothelialized, the flow resisting films gradually descend and are absorbed, so that the puncture interatrial puncture is conveniently carried out.
In this embodiment, some patients may also encounter other interventional procedures requiring heart disease after performing patent foramen ovale interventional occlusion or atrial septal defect interventional occlusion, such as atrial septal puncture, which is suitable for left atrial ablation, left atrial appendage occlusion, percutaneous mitral valve repair, etc. Consequently with this embodiment in interatrial septum stopper implant back, because the stopper is equipped with the puncture hole, and the choked flow membrane can be absorbed the degradation, consequently the pjncture needle passes interatrial septum tissue through the position in puncture hole more easily, can avoid the choked flow membrane to the resistance of pjncture needle, also can be smooth after the puncture is accomplished through other sheath pipes etc. to conveniently carry out other interventional operations of interatrial septum puncture postoperative.
While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (16)
1. An atrial septal defect occluder comprising:
-an elastically woven wire frame comprising a left and a right disk surface;
-a flexible connection member comprising a hollow cylindrical waist structure made of a flexible connection sheet, both ends of the flexible connection member connecting the proximal end of the left disc face and the distal end of the right disc face, respectively; the flexible connecting sheet is made of high polymer materials with good biocompatibility.
2. The atrial septal defect occluder of claim 1, wherein the outer wall of said flexible connecting sheet is coated with a hydrophilic swelling material capable of imbibing swelling upon contact with blood.
3. The atrial septal defect occluder of claim 2, wherein the hydrophilic swelling material comprises a medical grade hyaluronic acid material.
4. The atrial septal defect occluder of claim 1, wherein said flexible connector further comprises a plurality of elastic members, each of said elastic members having two ends connected to a proximal end of said left disc and a distal end of said right disc, respectively; the flexible connection sheet is of a double-layer structure, and the elastic element is arranged in a gap of the double-layer flexible connection sheet.
5. The atrial septal defect occluder of claim 4, wherein the flexible connecting sheet has a greater axial length in a flattened state than the natural axial length of the elastic member; the flexible connecting sheet material is provided with a continuous fold structure in the axial direction, and the axial length of the flexible connecting sheet material in a fold state is the same as that of the elastic element in a natural state.
6. The atrial septal defect occluder of claim 5, wherein said resilient member comprises a retractable spring or an elastomer made of a polymeric elastic material.
7. The atrial septal defect occluder of claim 1, wherein a fastener is attached to the proximal end of the right disc face, said fastener having a hollow channel; and a locking mechanism is arranged on the flexible connecting piece, one end of the locking mechanism is connected with the flexible connecting sheet, and the other end of the locking mechanism penetrates through the hollow channel of the fastener.
8. The atrial septal defect occluder of claim 7, wherein the fastener comprises a steel sleeve.
9. The atrial septal defect occluder of claim 7, wherein the locking mechanism comprises a plurality of pull wires and a locking member; one end of each of the plurality of traction wires is radially fixed on the inner side of the flexible connecting sheet, and the other ends of the plurality of traction wires are gathered together and connected with the locking element; the locking element includes structure that irreversibly enters the hollow passage of the fastener and completes the locking.
10. The atrial septal defect occluder of claim 8, wherein the locking element comprises a locking knot, a locking ball or a locking table.
11. The atrial septal defect occluder of claim 8, wherein there are at least two of said locking elements.
12. The atrial septal defect occluder of claim 7, wherein said flexible connecting sheet is made of a material having flow blocking properties.
13. The atrial septal defect occluder of claim 1, wherein the side of the left disc facing the left atrium and/or the side of the right disc facing the right atrium is a flat planar surface.
14. The atrial septal defect occluder of claim 1, wherein at least one puncture hole is formed in each of the left disk surface and the right disk surface, and the size of the puncture hole is larger than the mesh size of the elastic woven mesh frame.
15. The atrial septal defect occluder of any one of claims 1-14, further comprising a flow-blocking membrane comprising: the left disc flow-resisting film is arranged on the left disc surface, and the right disc flow-resisting film is arranged on the right disc surface.
16. The atrial septal defect occluder of claim 15, wherein said flow-blocking membrane is made of a biodegradable material.
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| CN202210371785.8A CN114767180B (en) | 2022-04-11 | 2022-04-11 | Atrial septal defect plugging device |
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| CN202210371785.8A CN114767180B (en) | 2022-04-11 | 2022-04-11 | Atrial septal defect plugging device |
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| CN114767180B (en) | 2023-05-12 |
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