CN111789697B - Vena cava filter with anti-tilting support arm and processing method thereof - Google Patents
Vena cava filter with anti-tilting support arm and processing method thereof Download PDFInfo
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- CN111789697B CN111789697B CN202010664445.5A CN202010664445A CN111789697B CN 111789697 B CN111789697 B CN 111789697B CN 202010664445 A CN202010664445 A CN 202010664445A CN 111789697 B CN111789697 B CN 111789697B
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- 238000003672 processing method Methods 0.000 title abstract description 7
- 238000011084 recovery Methods 0.000 claims abstract description 131
- 238000001914 filtration Methods 0.000 claims abstract description 22
- 238000004873 anchoring Methods 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 14
- 230000007704 transition Effects 0.000 claims description 14
- 230000002441 reversible effect Effects 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 6
- 238000003698 laser cutting Methods 0.000 claims description 5
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- 230000003247 decreasing effect Effects 0.000 claims description 3
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- 230000002265 prevention Effects 0.000 claims 2
- 230000000694 effects Effects 0.000 abstract description 11
- 230000002457 bidirectional effect Effects 0.000 description 23
- 210000004204 blood vessel Anatomy 0.000 description 15
- 230000008569 process Effects 0.000 description 11
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- 238000010586 diagram Methods 0.000 description 6
- 206010020718 hyperplasia Diseases 0.000 description 6
- 239000010410 layer Substances 0.000 description 6
- 206010051055 Deep vein thrombosis Diseases 0.000 description 5
- 206010047249 Venous thrombosis Diseases 0.000 description 5
- 238000005520 cutting process Methods 0.000 description 5
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- 238000002513 implantation Methods 0.000 description 4
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- 241000239290 Araneae Species 0.000 description 2
- 206010014522 Embolism venous Diseases 0.000 description 2
- 208000010378 Pulmonary Embolism Diseases 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
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- 208000014674 injury Diseases 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- 238000005498 polishing Methods 0.000 description 2
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- 241000251468 Actinopterygii Species 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
Abstract
The application relates to a vena cava filter with an anti-tilting support arm and a processing method thereof, belongs to the technical field of medical equipment, and solves the problems of poor filtering effect, poor self-neutrality and difficult recovery of the existing recyclable vena cava filter. The vena cava filter comprises a filter main body, a recovery part (1) and a filtering part, wherein the filter main body, the recovery part (1) and the filtering part are integrally arranged; the filtering part comprises a supporting component (3), the supporting component (3) consists of a plurality of supporting arms (31) and a plurality of supporting legs (32), and the supporting arms (31) and the supporting legs (32) are uniformly distributed along the circumferential direction of the main body of the filter; after the supporting arm (31) and the supporting leg (32) are opened, an upper opening filter cavity (311) and a lower opening filter cavity (321) are respectively formed. The application has good filtering effect, good self-neutrality of the filter and easy recovery.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to a vena cava filter with an anti-tilting support arm and a processing method thereof.
Background
Venous Thromboembolism (VTE) includes Deep Vein Thrombosis (DVT) and pulmonary arterial embolism (PE), which can be considered as different manifestations of the same disease in different periods, and fatal pulmonary arterial embolism caused by deep vein thrombosis seriously threatens the life health of the national population. At present, clinical treatment of deep vein thrombosis is mainly anticoagulation, but even if a sufficient amount of anticoagulant is administered, there is still a risk of fatal pulmonary arterial embolism. Implantation of the inferior vena cava filter is an effective means of preventing subsequent lethal pulmonary embolism following deep vein thrombosis.
The filter used in clinic is usually a permanent filter, but the filter can prevent pulmonary artery embolism and increase the occurrence risk of long-term thrombotic complications after the filter is implanted, thus limiting the wide application of the filter. In recent years, with the advent of recyclable filters, there has been an exposure to light from patients at high risk of temporary anticoagulation contraindicated or pulmonary arterial embolism.
However, the existing recyclable filter has poor self-neutrality, is easy to incline in vascular contents, and the barbs often cannot enter the sheath tube during recycling of the filter, so that the filter is difficult to recycle, and secondary injury is easily caused to patients. In addition, the filter screen of the existing filter adopts a single-layer filter screen design, so that the filter effect is poor, medium and small thrombus can permeate, and even thrombus separation and the like can occur. In addition, the existing recyclable filter has the defect of large contact area with the inner wall of the blood vessel and incapability of bidirectional regulation.
Disclosure of Invention
In view of the above analysis, the present application aims to provide a vena cava filter with an anti-tilting support arm and a processing method thereof, which are used for solving the problems of poor filtering effect, poor self-neutrality of the filter and difficult recovery of the existing recyclable vena cava filter.
The aim of the application is mainly realized by the following technical scheme:
in one aspect, a vena cava filter with anti-tilt support arms is provided that includes a filter body, a recovery portion, and a filter portion, the filter body, recovery portion, and filter portion being integrally disposed.
Further, the filtering portion includes a support assembly composed of a plurality of support arms and a plurality of support legs, which are uniformly distributed along a circumference of the filter body.
Further, the support arms and support legs can be opened to form an upper open filter cavity and a lower open filter cavity, respectively.
Further, the filtering portion is constituted by a support assembly composed of a plurality of support arms and a plurality of support legs) which are uniformly distributed along the circumference of the filter main body.
Further, the support arm is provided with a first end and a second end, wherein the first end is connected with the bottom end of the recovery part, and the second end is a free end and is positioned below the first end;
the first end and the second end have a peak and a trough therebetween, and a path along the surface of the support arm from the first end to the second end passes through the trough and the peak in sequence.
Further, the highest point of the supporting arm is higher than the connection point of the recovery part and the supporting arm.
Further, the number of the supporting arms and the supporting legs is 6.
Further, the support arm is of a first S-shaped structure, the part from the free end of the support arm to the crest is a regular arc section, and the highest point of the first S-shaped support arm is higher than the connection point of the recovery part and the first S-shaped support arm.
Further, the distance L1 between the highest point of the support arm of the first S-shaped structure and the central axis of the filter is 7-10 mm, and the vertical distance L2 between the highest point and the connection point of the recovery part and the support arm is 3-4 mm.
Further, the support arm is of a second S-shaped structure, the arc section from the free end of the support arm to the crest of the wave comprises a transition arc section and an inward concave arc section, the transition arc section is in arc transition connection with the inward concave arc section, and the inward concave arc section is a regular arc;
when the support arm is opened, the distance from the highest point of the wave crest to the end point of the free end is increased and then decreased, and the distance from the transitional connection point of the transitional arc section and the inward concave arc section to the central axis of the filter is the largest.
Further, the radius of the inward concave arc section is 4 mm-6 mm, and the included angle formed by the midpoint tangent line of the transition arc section and the central axis of the filter is 20-30 degrees.
Further, the vertical distance L4 between the highest point of the support arm of the second S-shaped structure and the highest point of the inner concave surface of the recovery hook is 0.5-1 mm.
Further, the distance L5 between the highest point of the support arm of the second S-shaped structure and the top end of the recovery hook is 0.5-1.5 mm.
Further, the filtering part is composed of a supporting component and a filter screen;
the filter screen comprises an upper filter screen and a lower filter screen, and the upper filter screen is connected with the lower filter screen through a connecting rod between the filter screens;
the projection of the filter screen on the projection plane perpendicular to the central axis of the vena cava filter is in a spider-web shape.
Further, the upper filter screen is of a first petal-shaped structure formed by a plurality of grids, the inner side connecting points of two adjacent grids are first concave parts of the first petal-shaped structure, and the outer side top points of each grid are first convex parts of the first petal-shaped structure;
the lower layer filter screen is a second petal-shaped structure formed by a plurality of grids, the area of the second petal-shaped structure is larger than that of the first petal-shaped structure, the inner side connecting points of two adjacent grid structures are second concave parts of the second petal-shaped structure, and the outer side top points of each grid are second convex parts of the second petal-shaped structure.
Further, the free end of the support arm has a circular arc structure.
Further, the supporting leg extends downwards from the lower end of the recovery part in an inclined mode, and an anchoring barb structure is arranged at the tail end of the supporting leg.
Further, the anchoring barb structure has both a forward barb and a reverse barb configuration.
Further, the recovery hook adopts an open structure, and the open structure is formed by rotating and cutting downwards along the top end of the recovery part, so that an arc-shaped sheet-shaped bulge with downwards is formed.
Further, a guiding part is arranged on the inner side of the arc-shaped sheet-shaped bulge and is obliquely arranged towards the top end of the recovery part and used for guiding the recovery lasso to be sleeved into the recovery hook.
Further, the support leg comprises a proximal portion and a distal portion, wherein an angle alpha between the distal portion and an extension line of the proximal portion is a centripetal inclination angle, and alpha is 3-5 degrees.
On the other hand, the application also provides a processing method of the vena cava filter with the anti-tilting support arm, wherein the vena cava filter is integrally cut by a laser cutting technology and is processed by heat treatment, sand blasting and electrochemical polishing processes.
Compared with the prior art, the vena cava filter with the anti-tilting support arm has at least one of the following beneficial effects:
(1) The highest point of the S-shaped structure supporting arm is higher than the connection point of the recovery part and the supporting arm, so that the filter supporting point is closer to the recovery hook, the recovery hook obtains more sufficient centering force, the inclination of the filter recovery hook can be effectively prevented, the adherence phenomenon can not occur, and the recovery of the filter is facilitated.
(2) The highest point of the supporting arm is higher than the highest point of the inner concave surface of the recovery hook, so that the recovery hook is positioned between the highest point of the supporting arm and the anchor point of the supporting leg, the inclination of the recovery hook of the filter can be effectively prevented, the adherence phenomenon can not occur, and the recovery of the filter is facilitated.
(3) The support arm with the S-shaped structure ensures that the contact area between the filter and the vascular wall is smaller, can effectively prevent vascular endothelial hyperplasia, prolongs implantation time, does not turn up in the release process, and avoids the support component from scratching the blood vessel.
(4) Adopt double-deck filter screen, be the spider web structure on the projection plane of perpendicular to the axis of vena cava filter, double-deck filter screen height is different, the area is different, forms a netted three-dimensional structure, can improve the efficiency of catching of filter to thrombus greatly, makes thrombus caught more completely, also can effectively prevent that thrombus from droing.
(5) The support component has the bidirectional support function, namely, the support arm forming the upper opening filter cavity and the support leg forming the lower opening filter cavity respectively, the contact area between the support component and the inner wall of the blood vessel of the structure is small, the endothelial hyperplasia can be effectively prevented, and the support component with the bidirectional support function enables the filter to have good self-neutrality, and the filter is effectively prevented from being biased and perforated.
(6) The supporting legs are provided with the centripetal structures, and the supporting legs are centripetally inclined at a certain angle in the recovery state, so that pushing force of the filter for recovering the sheath tube in the recovery process can be reduced, the recovery difficulty of the filter is reduced, and the operability of the filter is improved.
(7) The vena cava filter is provided with a bidirectional filter cavity structure with an upper opening filter cavity and a lower opening filter cavity, and the tail end of the supporting leg is provided with a barb structure with bidirectional anchoring, two anchoring directions are arranged at the same position, the bidirectional filter cavity and the bidirectional barbs can realize the purpose of bidirectional release of the filter in a single loading direction, and the filter can be recovered to the sheath tube in two puncture directions in the operation process to readjust the release position.
(8) The open type recovery hook structure is adopted, the cross section area is small, the recovery lasso is easy to catch, the recovery operation is easy, and the operation difficulty is reduced.
In the application, the technical schemes can be mutually combined to realize more preferable combination schemes. Additional features and advantages of the application will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the application. The objectives and other advantages of the application may be realized and attained by the structure particularly pointed out in the written description and drawings.
Drawings
The drawings are only for purposes of illustrating particular embodiments and are not to be construed as limiting the application, like reference numerals being used to refer to like parts throughout the several views.
FIG. 1A is a schematic diagram of a vena cava filter with a double-layer filter screen according to the application;
FIG. 1B is a schematic diagram of a vena cava filter with a double-layer filter screen according to the application;
FIG. 2 is a schematic illustration of a filter screen of the present application having a double layer filter screen in a spider-web configuration on a projection plane perpendicular to its central axis;
FIG. 3A is a schematic view of the structure of a recovery hook of the vena cava filter of the application;
FIG. 3B is a schematic diagram of a second embodiment of a recovery hook of the vena cava filter of the application;
FIG. 4 is a schematic view of the arc structure of the free end of the support arm of the present application;
figure 5A is a schematic view of the structure of the forward barb of the present application;
figure 5B is a schematic view of the structure of the reverse barb of the present application;
FIG. 6A is a schematic diagram of the vena cava filter release configuration with centripetal structural support legs of the application;
FIG. 6B is an enlarged view of a portion of the centripetal structure of FIG. 6A in the released state of the filter;
FIG. 7 is a schematic drawing showing the contraction of the support leg centripetal structure of the vena cava filter of the application in a collapsed state;
FIG. 8 is a schematic representation of the vena cava filter with dual screen delivery via jugular puncture according to the application;
FIG. 9 is a schematic representation of the vena cava filter with dual screen release via femoral vein puncture in accordance with the application;
FIG. 10A is a schematic view of a vena cava filter having a first S-shaped support arm in accordance with the application;
FIG. 10B is a schematic illustration of a vena cava filter having a second S-shaped support arm in accordance with the application;
FIG. 10C is an enlarged schematic view of the connection structure between the second S-shaped support arm and the recovery section in FIG. 10B;
FIG. 10D is a schematic diagram of a vena cava filter having a second S-shaped support arm in accordance with the application;
FIG. 10E is an enlarged schematic view of the connection structure between the second S-shaped support arm and the recovery section in FIG. 10D;
FIG. 11A is a schematic view of a vena cava filter transcervical release condition with a first S-shaped support arm of the application;
FIG. 11B is a schematic view of a vena cava filter with a first S-shaped support arm of the application in a transfemoral release state;
FIG. 12A is a schematic illustration of a vena cava filter transcervical release profile with a second S-shaped support arm in accordance with the application;
FIG. 12B is a schematic illustration of the vena cava filter with a second S-shaped support arm of the application in a femoral release state;
FIG. 13A is a schematic illustration of a vena cava filter with a second S-shaped support arm according to the application in a jugular vein release state;
fig. 13B is a schematic diagram of a vena cava filter with a second S-shaped support arm according to the application in a femoral release state.
Reference numerals:
1-a recovery unit; 11-a recovery hook; 111-arc-shaped sheet-like projections; 112-a guide; 2-a filter screen; 21-an upper filter screen; 211-a first recess; 212-a first protrusion; 22-a lower filter screen; 221-a second recess; 222-a second protrusion; 23-connecting rods between filter screens; 24-a first connecting rod; 25-a second connecting rod; 3-a support assembly; 31-a support arm; 311-an upper open filter cavity; 312-arc structure; 313-concave arc segment; 32-supporting legs; 321-a lower opening filter chamber; 322-positive barbs; 323-reverse barb; 324-centripetal structure.
Detailed Description
The following detailed description of preferred embodiments of the application is made in connection with the accompanying drawings, which form a part hereof, and together with the description of the embodiments of the application, are used to explain the principles of the application and are not intended to limit the scope of the application.
Example 1
In one embodiment of the present application, a vena cava filter with a double-layered filter screen is disclosed, as shown in fig. 1A and 1B, the vena cava filter comprises a filter body, a recovery part 1 and a filtering part, and the filter body, the recovery part 1 and the filtering part are integrally cut; the recovery part 1 is arranged at the end part of the filter main body, the recovery part 1 is provided with a recovery hook 11, the recovery hook 11 and the filter main body are integrally formed, and the recovery hook 11 is matched with the conveying device to realize recovery and release of the vena cava filter; the filtering part consists of a filter screen 2 and a supporting component 3.
Further, the filter screen 2 includes an upper filter screen 21 and a lower filter screen 22, the upper filter screen 21 and the lower filter screen 22 are connected by a connecting rod 23 between the filter screens, as shown in fig. 2, the filter screen 2 is in a spider-web structure on a projection plane perpendicular to the central axis of the vena cava filter.
Still further, as shown in fig. 2, the upper filter 21 is a first petal-shaped structure formed by a plurality of grids, the inner connection point of two adjacent grids is a first concave portion 211 of the first petal-shaped structure, and the outer vertex of each grid is a first convex portion 212 of the first petal-shaped structure. The lower filter screen 22 is a second petal-shaped structure formed by a plurality of grids, the area of the second petal-shaped structure is larger than that of the first petal-shaped structure, the inner side connection points of two adjacent grid structures are second concave parts 221 of the second petal-shaped structure, the outer side top point of each grid is a second convex part 222 of the second petal-shaped structure, in the axial direction, a first concave part 211 of the first petal-shaped structure corresponds to the second concave part 221 of the second petal-shaped structure, and a first convex part 212 of the first petal-shaped structure corresponds to the second convex part 222 of the second petal-shaped structure. The support legs 32 are fixedly connected to the upper screen 21 by the first connecting rod 24, the support legs 32 are fixedly connected to the lower screen 22 by the second connecting rod 25, and in a preferred embodiment, the support legs 32 are fixedly connected to the first recess 211 of the upper screen 21 by the first connecting rod 24, and the support legs 32 are fixedly connected to the second recess 221 of the lower screen 22 by the second connecting rod 25.
Further, the support assembly 3 is composed of a plurality of support arms 31 and a plurality of support legs 32, the plurality of support arms 31 extend from the second recess 221 at the end of the lower filter screen 22, the plurality of support arms 31 extend outwards and gradually turn towards the direction of the recovery part to form an upper opening filter cavity 311, the plurality of support legs 32 extend downwards from the proximal end of the recovery part 1 to form a lower opening filter cavity 321, and each support leg 32 is fixedly connected with the upper filter screen 21 and the lower filter screen 22.
In one embodiment, the support arm 31 extends outwardly from the second protrusion 222 of the lower screen 22 and gradually turns over and curls in the direction of the recovery section 1 to form an upper open filter cavity 311.
In one embodiment, the plurality of support arms 31 and the plurality of support legs 32 are uniformly distributed along the circumference of the vena cava filter, and the number 32 of support arms 31 and support legs 32 is the same. In a preferred embodiment, the number of support arms 31 and support legs 32 is six.
As shown in fig. 4, the free end of the support arm 31 has a circular arc structure 312. The free ends of the support arms 31 forming the upper open filter cavity 311 are rounded to prevent scoring or puncturing the inner wall of the vessel.
As shown in fig. 5A and 5B, the support leg 32 extends obliquely downward from the lower end of the recovery portion 1, and an anchoring barb structure having two structures of a forward barb 322 and a reverse barb 323 is provided at the end of the support leg 32, the forward barb 322 and the reverse barb 323 having two opposite anchoring directions.
In one embodiment, the ends of the support legs 32 are provided with two forward barbs 322 and reverse barbs 323 having different anchoring directions, the tips of the forward barbs 322 and the reverse barbs 323 are disposed opposite to each other, and the contact surfaces of the forward barbs 322 and the reverse barbs 323 with the blood vessel wall are smooth. As shown in fig. 8 and 9, the vena cava filter of the present application is released by jugular puncture or by femoral puncture, and the filter can be retracted into the sheath to readjust the release position during the operation in both puncture directions.
In one embodiment, the barbs 322 on adjacent support legs 32 are oriented differently and the barbs 322 on spaced support legs 32 are oriented identically.
The vena cava filter of the embodiment is manufactured by a series of prior processes of integrally cutting nickel-titanium alloy materials through a laser cutting technology, heat treatment, sand blasting, electrochemical polishing and the like.
In this embodiment, the recovery hook 11 is formed by an open structure, as shown in fig. 3A, by rotating and cutting the open structure downward along the top end of the recovery portion 1, and a downward arc-shaped sheet-like protrusion 111 is formed, and the recovery hook 11 after rotating and cutting has the highest point of the concave surface, and the highest point of the concave surface is not located on the central axis of the filter. The arcuate tab 111 is open on one side and has an area of its connection with the recovery lasso that is less than one half of the cross-sectional area of the recovery section 1. The cross-sectional area of the recovery part of the structure is small, the recovery lasso is easy to catch the filter, and the operation difficulty is reduced.
Further, as shown in fig. 3B, a guiding portion is provided on the inner side of the arc-shaped sheet-shaped protrusion 111, and is inclined toward the top end of the recovering portion 1, and is used for guiding the recovering lasso to be sleeved into the recovering hook 11, the guiding portion is in a smooth rod-shaped structure, one end of the guiding portion is located on the inner side of the arc-shaped sheet-shaped protrusion 111, the other end of the guiding portion is located in the concave space of the recovering hook and is not in contact with the inner wall of the concave space of the recovering hook 11, and a gap is reserved between the other end of the guiding portion and the inner wall of the concave space of the recovering hook 11, so that the recovering lasso can be sleeved into or removed. When the recovery lasso catches the filter, the lasso slides into the concave space of the recovery hook 11 along the obliquely arranged guide part, and the recovery lasso can be prevented from sliding out of the recovery hook 11 when the filter is recovered due to the guide part, so that the working reliability of the filter is improved.
Considering that in the prior art, because the barb structure is arranged, barbs cannot enter the sheath tube when the filter is recovered, the filter is difficult to recover, and secondary injury is easily brought to a patient. In this embodiment, the free ends of the support legs 32 are provided with centripetal structures 324, and as shown in fig. 6A and 6B, the support legs 32 include a proximal end portion and a distal end portion, and the centripetal structures 324 are formed by turning the distal end portions of the support legs 32 outward by 90 ° along the center line of the support legs 32 in the heat treatment setting stage and bending them counterclockwise in the top view, that is, after the distal end portions are suspended by 90 ° so that the barbs are positioned outside the lower opening filter cavity 321. In the released state of the vena cava filter, the angle between the distal end portion of the support leg 32 and the extension line of the proximal end portion of the support leg 32 is the centripetal tilt angle α of the centripetal structure 324. As shown in fig. 7, in the recovered state of the vena cava filter, the centripetal inclination angle α is equal to the angle between the extension line of the distal end portion of the support leg 32 and the central axis of the vena cava filter. Furthermore, the centripetal inclination angle alpha is 3-5 degrees. The vena cava filter of the embodiment adopts the supporting leg 32 with the centripetal structure, so that the supporting leg 32 can centripetally incline for a certain angle in the recovery state, and the pushing force of the recovery sheath tube of the filter in the recovery process can be reduced by the structural design, and the recovery difficulty of the filter is reduced.
In operation, the vena cava filter of the application has good filtering effect both through jugular puncture and through femoral puncture, firstly, the vena cava filter is slowly pushed out from the delivery sheath, the supporting legs 32 are opened, barbs are anchored on the inner wall of a blood vessel when the vena cava filter is opened to a certain extent to form a lower opening filter cavity, then the vena cava filter is continuously released, the supporting arm 31 is pushed out, and is slowly curled towards the direction of the recovery part to form an upper opening filter cavity, and the vena cava filter gradually completes the work of adjusting the centrality of the vena cava filter in the releasing process of the supporting arm 31, so that the vena cava filter has good self-neutrality. The vena cava filter with double-layer filter screen is released by jugular puncture, as shown in fig. 8, the recovery hook 11 is connected with the delivery device, and when the release state is not ideal, the vena cava filter can be recovered to the delivery sheath to readjust the position for release again. The vena cava filter with double-layer filter screen is released by femoral vein puncture, as shown in fig. 9, the recovery hook 11 is connected with the delivery device, and when the release state is not ideal, the vena cava filter can be recovered to the readjusted position in the delivery sheath for release again.
Compared with the prior art, the vena cava filter with the inclination-preventing supporting arm of the embodiment has at least the following beneficial effects:
(1) Adopt double-deck filter screen, be the spider web structure on the projection plane of the axis of perpendicular to vena cava filter, double-deck filter screen height is different, and the area is different, forms a netted three-dimensional structure, can improve the efficiency of catching of filter to thrombus greatly, makes thrombus caught more completely, also can effectively prevent that thrombus from droing.
(2) The support component has the bidirectional support function, namely, the support arm forming the upper opening filter cavity and the support leg forming the lower opening filter cavity respectively, the contact area between the support component and the inner wall of the blood vessel of the structure is small, the endothelial hyperplasia can be effectively prevented, and the support component with the bidirectional support function enables the filter to have good self-neutrality, and the filter is effectively prevented from being biased and perforated.
(3) The supporting legs are provided with the centripetal structures, and the supporting legs are centripetally inclined at a certain angle in the recovery state, so that pushing force of the filter for recovering the sheath tube in the recovery process can be reduced, the recovery difficulty of the filter is reduced, and the operability of the filter is improved.
(4) The vena cava filter has a bidirectional filter cavity structure of an upper opening filter cavity 311 and a lower opening filter cavity 321, and a barb structure with bidirectional anchoring arranged at the tail end of the supporting leg has two anchoring directions at the same position, and the bidirectional filter cavity and the bidirectional barb can realize the purpose of bidirectional release of the filter in a single loading direction.
(5) The release process does not have upturning action, and the supporting component does not need to scratch the blood vessel.
(6) The anchoring barbs are bidirectionally anchored, the barbs have two anchoring directions at the same fixed position of the filter, bidirectional release of the filter in a single loading direction can be realized, and the filter can be recovered to the sheath tube in two puncture directions in the operation process to readjust the release position.
(7) The open type recovery hook structure is adopted, the cross section area is small, the recovery lasso is easy to catch, the recovery operation is easy, and the operation difficulty is reduced.
(8) The free ends of the supporting legs are subjected to arc smoothing treatment, so that the inner wall of the blood vessel is effectively prevented from being scratched or pierced.
Example 2
In another embodiment of the present application, a vena cava filter with an inclination-preventing support arm is disclosed, comprising a filter main body, a recovery unit 1 and a filtering unit, wherein the filtering unit is formed by a support assembly 3, a filter screen 2 is not provided, the support arm 31 extends outwards from the bottom end of the recovery unit 1, the support assembly 3 is in an S-shaped structure, and the support assembly 3 formed by a plurality of support legs 32 and a plurality of support arms 31 in an S-shaped structure can play the role of the filter screen, and has a simple structure and a good filtering effect.
In this embodiment, the supporting arm 31 has a first end and a second end, the first end is connected to the bottom end of the recovery unit 1, and the second end is a free end and is located below the first end. A peak and a trough are arranged between the first end and the second end, the track moving from the first end to the second end passes through the trough and the peak sequentially along the surface of the supporting arm 31, and the highest point of the supporting arm 31 is higher than the connection point of the recovery part 1 and the supporting arm 31. When the support assembly 3 is opened, the trough space is the upper open filter cavity 311.
As shown in fig. 10A, 10B and 10D, the support assembly 3 is composed of a plurality of support legs 32 and a plurality of support arms 31 in an S-shaped structure, the plurality of support arms 31 and the plurality of support legs 32 being uniformly distributed along the circumferential direction of the vena cava filter body. The supporting leg 32 is formed by extending the bottom end of the recovery part 1 obliquely downwards, and the included angle beta formed by the supporting leg 32 and the central axis of the filter is 30-40 degrees. The filter part has an upper open filter cavity 311 and a lower open filter cavity 321 after being opened (i.e., after the support arms 31 and the support legs 32 are completely opened), the upper open filter cavity 311 is composed of a plurality of support arms 31 which are uniformly distributed circumferentially, and the lower open filter cavity 321 is composed of a plurality of support legs 32 which are uniformly distributed circumferentially.
Considering that the number of the supporting arms 31 and the supporting legs 32 affects the filtering effect, the number of the supporting arms 31 and the supporting legs 32 in the embodiment is 6, that is, the supporting assembly 3 is composed of 6 supporting arms 31 and 6 supporting legs 32, if the number of the supporting arms 31 and the supporting legs 32 is too small, the supporting force of the filter is insufficient, and the filter is subject to potential risks of displacement, perforation, inclination and the like; if the number of the support arms 31 and the support legs 32 is too large, the contact area between the filter and the vessel wall is increased, so that the proliferation of the vascular endothelial tissue is accelerated, the recovery window time is shortened, and the risk of re-thrombosis is increased. The number of the supporting arms 31 and the number of the supporting legs 32 in the embodiment are all 6, and the position parameters of the highest point of the S-shaped supporting arm and the connecting point of the S-shaped supporting arm and the recovery part 1 are set, so that the structure of the filter in the embodiment is simpler, the offset and perforation of the filter are effectively prevented, and the working reliability of the filter is improved.
Considering that the vena cava filters have different working environments in vena cava vessels with different diameters, the centering performance of the filters is required to be higher. In this embodiment, in order to adapt the vena cava filter to vena cava vessels with different diameters, the support arm 31 with an S-shaped structure is further improved and optimized, specifically, the support arm 31 has two S-shaped structures, namely a first S-shaped support arm and a second S-shaped support arm, the vena cava filter with the first S-shaped support arm is especially suitable for vena cava vessels with slightly smaller diameters, and the vena cava filter with the second S-shaped support arm is especially suitable for vena cava vessels with slightly larger diameters. The specific structure of the two support arms is as follows:
the part from the free end of the first S-shaped supporting arm to the crest is a regular arc section, and further, the length of the arc section is 1/2 circumference. The highest point of the first S-shaped supporting arm is higher than the connection point of the recovery part 1 and the supporting arm 31, namely the peak position of the first S-shaped supporting arm is higher than the connection point of one end of the first S-shaped supporting arm and the recovery part 1; further, the distance L1 between the highest point of the first S-shaped supporting arm and the central axis of the filter is 7-10 mm, the vertical distance L2 between the highest point of the first S-shaped supporting arm and the connecting point of the recovery part 1 and the supporting arm 31 is 3-4 mm, and the structural parameter is set, so that the vena cava filter has a good self-centering effect in a vena cava vessel with a small diameter, the inclination of the vena cava filter is effectively avoided, and the working reliability of the vena cava filter is ensured.
The free end of second S type support arm is the irregular circular arc section to the part of crest, and the free end sets up the indent structure, and the indent structure is indent circular arc section 313, and after the support arm was opened, indent circular arc section 313 was drawn in to the axis of filter, can prevent effectively that support arm 31 from fish tail blood vessel inner wall. Specifically, the arc section from the free end to the peak comprises a transition arc section and an inner concave arc section 313, the transition arc section and the inner concave arc section 313 are in arc transition connection, the inner concave arc section 313 is a regular arc, the radius of the inner concave arc section 313 is 4-6 mm, and an included angle formed by the midpoint tangent line of the transition arc section and the central axis of the filter is 20-30 degrees. When the support arm 31 is opened, the distance from the highest point of the wave crest to the end point of the free end is increased and then decreased, and the distance from the transitional connection point of the transitional arc section and the inward concave arc section 313 to the central axis of the filter is the largest. After the support arm 31 is opened, the highest point of the peak, the end point of the free end, and the connection point of the transition arc section and the concave arc section 313 form an obtuse triangle, wherein the linear distance from the highest point of the peak to the end point of the free end is a, the linear distance from the highest point of the peak to the connection point of the transition arc section and the concave arc section 313 is b, the linear distance from the end point of the free end to the connection point of the transition arc section and the concave arc section 313 is c, c is more than 0, a is more than b and is more than c, and c is less than or equal to 1/5 of a.
Further, the highest point of the second S-shaped support arm is higher than the highest point of the inner concave surface of the recovery hook 11, and the distance L3 between the highest point of the second S-shaped support arm and the central axis of the filter is 9-12 mm.
In a preferred embodiment of this embodiment, as shown in fig. 10C, the vertical distance L4 between the highest point of the second S-shaped support arm and the highest point of the concave surface of the recovery hook 11 is 0.5-1 mm, and the above configuration parameter setting not only can effectively avoid the support arm 31 from scratching the inner wall of the blood vessel, but also improves the centering effect of the filter, reduces the inclination of the filter during use, and causes the puncture of the blood vessel, thereby greatly improving the working stability and reliability of the filter.
In still another preferred embodiment of this embodiment, as shown in fig. 10E, the highest point of the second S-shaped support arm is higher than the top end of the recovery hook 11, and the distance L5 between the highest point of the second S-shaped support arm and the top end of the recovery hook 11 is 0.5-1.5 mm, and this configuration parameter setting not only has good centering effect, but also can prevent the top end of the recovery hook 11 from being close to the vessel wall, so that the catcher cannot catch or catch the recovery hook, resulting in difficulty in recovery of the filter, and improving the working stability and reliability of the filter.
The supporting leg 32 and the recovery unit 1 in this embodiment are the same as the supporting leg 32 and the recovery unit 1 in embodiment 1, and the description thereof will not be repeated here.
In the operation process, the vena cava filter of this embodiment has a good filtering effect through both jugular puncture and femoral puncture, firstly, the vena cava filter is slowly pushed out from the delivery sheath, the supporting legs 32 are opened, barbs can be anchored on the inner wall of a blood vessel when the vena cava filter is opened to a certain extent to form a lower opening filter cavity 321, then the vena cava filter is continuously released, the supporting arms of the S-shaped structure are pushed out and slowly opened towards the direction of the recovery part to form an upper opening filter cavity 311, and the vena cava filter gradually completes the work of adjusting the centrality of the vena cava filter in the releasing process of the supporting arms of the S-shaped structure, so that the vena cava filter has good self-neutrality. The vena cava filter with S-shaped supporting arm is released by jugular puncture as shown in fig. 11A, 12A and 13A, the recovery hook 11 is connected with the delivery device, when the releasing state is not ideal, the vena cava filter can be recovered to the position in the delivery sheath for readjustment, and then released again. The vena cava filter with the S-shaped supporting arm is released by femoral vein puncture, as shown in fig. 11B, 12B and 13B, and when the releasing state is not ideal, the vena cava filter can be recovered to the readjusted position in the delivery sheath and released again by connecting the recovery hook 11 with the delivery device.
Compared with the prior art, the vena cava filter with the inclination-preventing supporting arm of the embodiment has at least the following beneficial effects:
(1) The highest point of the S-shaped structure supporting arm is higher than the connection point of the recovery part and the supporting arm, so that the filter supporting point is closer to the recovery hook, the recovery hook obtains more sufficient centering force, the inclination of the filter recovery hook can be effectively prevented, the adherence phenomenon can not occur, and the recovery of the filter is facilitated.
(2) The highest point of the supporting arm is higher than the highest point of the inner concave surface of the recovery hook, so that the recovery hook is positioned between the highest point of the supporting arm and the anchor point of the supporting leg, the inclination of the recovery hook of the filter can be effectively prevented, the adherence phenomenon can not occur, and the recovery of the filter is facilitated.
(3) The support arm with the S-shaped structure ensures that the contact area between the filter and the vascular wall is smaller, can effectively prevent vascular endothelial hyperplasia, prolongs implantation time, does not turn up in the release process, and avoids the support component from scratching the blood vessel.
(4) The support component has the bidirectional support function, namely, the support arm forming the upper opening filter cavity and the support leg forming the lower opening filter cavity respectively, the contact area between the support component and the inner wall of the blood vessel of the structure is small, the endothelial hyperplasia can be effectively prevented, and the support component with the bidirectional support function enables the filter to have good self-neutrality, and the filter is effectively prevented from being biased and perforated.
(5) The supporting legs are provided with the centripetal structures, and the supporting legs are centripetally inclined at a certain angle in the recovery state, so that pushing force of the filter for recovering the sheath tube in the recovery process can be reduced, the recovery difficulty of the filter is reduced, and the operability of the filter is improved.
(6) The vena cava filter is provided with a bidirectional filter cavity structure with an upper opening filter cavity and a lower opening filter cavity, and the tail end of the supporting leg is provided with a barb structure with bidirectional anchoring, two anchoring directions are arranged at the same position, the bidirectional filter cavity and the bidirectional barbs can realize the purpose of bidirectional release of the filter in a single loading direction, and the filter can be recovered to the sheath tube in two puncture directions in the operation process to readjust the release position.
(7) The open type recovery hook structure is adopted, the cross section area is small, the recovery lasso is easy to catch, the recovery operation is easy, and the operation difficulty is reduced.
(8) The free ends of the supporting legs are subjected to arc smoothing treatment, so that the inner wall of the blood vessel is effectively prevented from being scratched or pierced.
Example 3
In still another embodiment of the present application, a method for processing the vena cava filter in embodiments 1 to 2 is disclosed, wherein the processing process is as follows: the vena cava filter is integrally cut by a laser cutting technology and is processed by a heat treatment, sand blasting and electrochemical polishing process.
Specific: the nickel-titanium alloy tube is cut by a laser cutting machine to obtain a filter before molding, the filter before molding is subjected to shaping treatment by a heat treatment die, and the final filter structure is obtained by surface treatment procedures such as sand blasting, electrochemical polishing and the like after the filter molding.
When the recovery hook 11 is cut, the recovery hook 1 is rotated downward along the top end of the recovery portion 1 to form a downward arc-shaped sheet-like projection 111, and the rotated recovery hook 11 has the highest point of the concave surface which is not located on the central axis of the filter. One side of the arcuate tab shaped protrusion 111 is open and the area of the portion thereof connected to the recovery lasso is less than one half of the cross-sectional area of the recovery portion 1.
In manufacturing the support arm 31 in example 2, the support arm 31 was cut into an S-shaped structure so that the highest point of the support arm 31 was higher than the connection point of the recovery portion 1 and the support arm 31, and vena cava filters having support arms of different S-shaped structures were manufactured by cutting according to specific parameters of the two S-shaped structure support arms in example 2.
In the fabrication of the support legs 32 of examples 1 and 2, the support legs 32 form an angle β of 30 to 40 ° with the central axis of the strainer, and the anchor barbs are cut at the ends of the support legs 32.
Compared with the prior art, the processing method of the vena cava filter provided by the embodiment is simple to operate, the contact area between the manufactured vena cava filter and the vascular wall is smaller, vascular endothelial hyperplasia is effectively prevented, implantation time is prolonged, and the vena cava filter has excellent centering performance and good working reliability.
The present application is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are intended to be included in the scope of the present application.
Claims (8)
1. The vena cava filter with the inclination-preventing support arm is characterized by comprising a filter main body, a recovery part (1) and a filtering part, wherein the filter main body, the recovery part (1) and the filtering part are integrally arranged, the filtering part comprises a support component (3), the support component (3) consists of a plurality of support arms (31) and a plurality of support legs (32), and the support arms (31) and the support legs (32) are uniformly distributed along the circumferential direction of the filter main body;
the supporting leg (32) extends downwards obliquely from the lower end of the recovery part (1), and two forward barbs (322) and reverse barbs (323) with different anchoring directions are arranged at the tail end of the supporting leg (32), and the tips of the forward barbs (322) and the reverse barbs (323) are arranged oppositely;
the barb anchoring directions of the adjacent support legs (32) are different, and the barb anchoring directions of the support legs (32) arranged at intervals are the same;
the free end of the supporting leg (32) is provided with a centripetal structure (324), the supporting leg (32) comprises a proximal end part and a distal end part, the included angle alpha between the distal end part and the extension line of the proximal end part is a centripetal inclination angle, and the alpha is 3-5 degrees;
wherein the centripetal structure (324) is formed by turning the distal end portion 90 ° outward along the center line of the support leg (32) and bending it in a counterclockwise direction in a top view;
the support arm (31) and the support leg (32) can respectively form an upper opening filter cavity (311) and a lower opening filter cavity (321) after being opened;
when the supporting arm (31) is in a first S-shaped structure, the part from the free end of the supporting arm (31) to the crest is a regular arc section, and the highest point of the first S-shaped supporting arm is higher than the connecting point of the recovery part (1) and the first S-shaped supporting arm;
when the support arm (31) is in a second S-shaped structure, an arc section from the free end of the support arm (31) to the wave crest comprises a transition arc section and an inward concave arc section (313), the transition arc section is in arc transition connection with the inward concave arc section (313), and the inward concave arc section (313) is a regular arc;
when the supporting arm (31) is opened, the distance from the highest point of the wave crest to the end point of the free end is firstly increased and then decreased, the distance from the transitional connection point of the transitional arc section and the inward concave arc section (313) to the central axis of the filter is the largest,
the highest point of the supporting arm (31) is higher than the connection point of the recovery part (1) and the supporting arm (31).
2. Vena cava filter with anti-tilting support arms according to claim 1, characterized in that the support arm (31) has a first end connected to the bottom end of the recovery section (1) and a second end, free and situated below the first end;
a peak and a trough are provided between the first end and the second end, and a trajectory moving from the first end to the second end passes through the trough and the peak in sequence along the surface of the support arm (31).
3. Vena cava filter with anti-tilting support arms according to claim 2, characterized in that the number of support arms (31) and support legs (32) is 6.
4. Vena cava filter with anti-tilting support arms according to claim 1, characterized in that the filtering part is composed of a support assembly (3) and a screen (2);
the filter screen (2) comprises an upper filter screen (21) and a lower filter screen (22), and the upper filter screen (21) and the lower filter screen (22) are connected through a connecting rod (23) between the filter screens;
the projection of the filter screen (2) on a projection plane perpendicular to the central axis of the vena cava filter is in a spider-web shape.
5. Vena cava filter with anti-tilting support arms according to claim 4, characterized in that the upper screen (21) is a first petal-shaped structure composed of a plurality of grids, the inner connection point of two adjacent grids is a first concave part (211) of the first petal-shaped structure, and the outer vertex of each grid is a first convex part (212) of the first petal-shaped structure;
the lower filter screen (22) is a second petal-shaped structure formed by a plurality of grids, the area of the second petal-shaped structure is larger than that of the first petal-shaped structure, the inner side connecting points of two adjacent grid structures are second concave parts (221) of the second petal-shaped structure, and the outer side top point of each grid is a second convex part (222) of the second petal-shaped structure.
6. Vena cava filter with tilting prevention support arms according to claim 1, characterized in that the recovery hooks (11) are of an open structure which is cut by rotating down the top end of the recovery section (1) to form a sheet-like projection (111) with a downward arc.
7. Vena cava filter with tilting prevention support arms according to claim 6, characterized in that the inside of the arc-shaped sheet-like protrusion (111) is provided with a guide part (112), the guide part (112) being arranged obliquely to the top end of the recovery part (1) for guiding the recovery lasso to be sleeved into the recovery hook (11).
8. A method of manufacturing a vena cava filter having a tilt-preventing support arm as claimed in any one of claims 1 to 7, wherein the vena cava filter is integrally cut by a laser cutting technique, and is manufactured by a heat treatment, sand blasting, electrochemical polishing process.
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