CN114831698A - Thrombectomy device for transcatheter pulmonary artery thrombectomy system - Google Patents
Thrombectomy device for transcatheter pulmonary artery thrombectomy system Download PDFInfo
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- CN114831698A CN114831698A CN202210271447.7A CN202210271447A CN114831698A CN 114831698 A CN114831698 A CN 114831698A CN 202210271447 A CN202210271447 A CN 202210271447A CN 114831698 A CN114831698 A CN 114831698A
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- 210000001147 pulmonary artery Anatomy 0.000 title claims abstract description 12
- 238000013151 thrombectomy Methods 0.000 title claims description 31
- 238000013156 embolectomy Methods 0.000 claims abstract description 111
- 208000007536 Thrombosis Diseases 0.000 claims abstract description 89
- 238000000605 extraction Methods 0.000 claims abstract description 16
- 230000008602 contraction Effects 0.000 claims abstract description 10
- 238000012800 visualization Methods 0.000 claims description 9
- 229920002614 Polyether block amide Polymers 0.000 claims description 6
- 239000007769 metal material Substances 0.000 claims description 6
- 239000002861 polymer material Substances 0.000 claims description 6
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 6
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 6
- 239000000203 mixture Substances 0.000 claims description 5
- 238000009940 knitting Methods 0.000 claims description 4
- 230000004323 axial length Effects 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 3
- 238000009998 heat setting Methods 0.000 claims description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims 1
- 238000000034 method Methods 0.000 description 11
- 208000010378 Pulmonary Embolism Diseases 0.000 description 6
- 208000005189 Embolism Diseases 0.000 description 5
- 210000004204 blood vessel Anatomy 0.000 description 4
- 238000009941 weaving Methods 0.000 description 4
- 238000010276 construction Methods 0.000 description 3
- 230000004927 fusion Effects 0.000 description 3
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- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 description 2
- 229910001080 W alloy Inorganic materials 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000003073 embolic effect Effects 0.000 description 2
- ZONODCCBXBRQEZ-UHFFFAOYSA-N platinum tungsten Chemical compound [W].[Pt] ZONODCCBXBRQEZ-UHFFFAOYSA-N 0.000 description 2
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 2
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- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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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
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
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- Life Sciences & Earth Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus extractor for a transcatheter pulmonary artery thrombus extraction system. A thrombus extractor for a transcatheter pulmonary artery thrombus extraction system comprises a thrombus extraction bracket; the guide head is positioned at the far end of the embolectomy bracket; the thrombus taking support is made of a wire harness and is provided with meshes which are of a gradient structure with a dense far end and a sparse near end; the far end of the pushing rod is fixedly connected to the near end of the thrombus extraction support and covers the near end wiring harness of the thrombus extraction support; the pull tube is positioned in the embolectomy bracket, the near end of the pull tube penetrates through the embolectomy bracket and extends to the operation end of the embolectomy system, and the far end of the pull tube is fixedly connected with the guide head; when the pull tube moves axially, the plug taking bracket and the guide head are driven. The components of the thrombus extraction bracket are simple and convenient to connect and fix, and the deformation problem of the thrombus extraction bracket is greatly reduced, so that the thrombus extraction bracket has a better expansion state, can grab thrombus to the maximum extent and can be easily gathered, and the contraction deformation is buffered when the thrombus is withdrawn, so that the loss of the thrombus is avoided.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus extractor for a transcatheter pulmonary artery thrombus extraction system.
Background
Pulmonary Embolism (PE) refers to Pulmonary circulatory disorder caused by the obstruction of Pulmonary arteries or their branches by shed thrombus or other substances, and has the characteristics of high incidence of disease, high mortality, high recurrence rate, and high missed diagnosis. PE is also the third leading cause of cardiovascular death after coronary heart disease and stroke, with a 30 day mortality rate of 30% and 11% of patients dying within the first hour after admission if untreated. The number of cases diagnosed worldwide per year is over 1000 million, of which 100 ten thousand occur in the united states and more than 70 ten thousand occur in france, italy, germany, spain, sweden and the uk. According to domestic statistics, about 110 of 10 ten thousand adults can suffer from pulmonary embolism, and the incidence rate is on the rise in recent years. The traditional methods for treating pulmonary embolism at present comprise drug therapy, thrombolytic therapy and traditional operation therapy. The minimally invasive interventional therapy can overcome the defects of the traditional treatment method, and the treatment of acute pulmonary embolism is a technology with great prospect at present.
However, in the prior art, the thrombus taking support has a sparse structure, the risk of thrombus breakage is easily increased in the thrombus taking process, the actual thrombus grabbing rate is low, and the broken fine thrombus easily forms a far-end thrombus factor. Therefore, it is necessary to improve it to overcome the disadvantages in practical applications.
Disclosure of Invention
The invention aims to solve the technical problem of low thrombus capture rate caused by sparse thrombus extraction support structure in the prior art, and aims to provide a thrombus extractor for a ducted pulmonary artery thrombus extraction system.
A thrombus extractor for a ducted pulmonary artery thrombus extraction system comprises a thrombus extraction bracket; a guide head located at the distal end of the thrombectomy support;
the thrombus removal support is made of a wire harness and is provided with meshes, and the meshes are of a gradient structure with a dense far end and a sparse near end;
further comprising:
the far end of the pushing rod is fixedly connected to the near end of the embolectomy support and covers the near end wiring harness of the embolectomy support;
the pull tube is positioned in the embolectomy support, the near end of the pull tube penetrates through the embolectomy support and extends to the operation end of the embolectomy system, the far end of the pull tube is fixedly connected with the guide head, and the pull tube is a piston-type pull tube;
and when the pull pipe moves axially, the plug taking support and the guide head are driven.
Preferably, the pull pipe is a piston type pull pipe formed by mixing one or more of PEBAX and PTFE high polymer materials.
Preferably, the two ends of the pull tube are provided with a necking for connection, the diameter of the necking is between the minimum outer diameter of the pull tube and the minimum inner diameter of the push rod, and the necking is fixedly connected to the inside of the far end of the push rod.
Preferably, the diameter of the necking is 1.41 mm-1.45 mm, and the axial length of the necking section is 2 mm-3 mm.
Preferably, the pull tube is coaxial with the embolectomy support, and the pull tube limits expansion or contraction of the embolectomy support.
Preferably, the outer wall of the far end of the pull tube and the far end wire harness of the embolectomy support are connected into a whole through a far end fixing sleeve, and the outer surface of the far end fixing sleeve is connected to the inside of the near end of the guide head, so that the outer wall of the far end of the pull tube, the far end wire harness of the embolectomy support and the guide head are connected into a whole through the far end fixing sleeve.
Preferably, the distance between the outer part of the distal end of the pull tube and the distal end of the thrombus removal stent is 5mm to 20mm, preferably 12mm to 18mm, and more preferably 13mm to 15 mm.
Preferably, the inner wall of the far end of the push rod is wrapped on the near-end wire harness of the embolectomy support and is connected into a whole through a near-end fixing sleeve.
Preferably, the proximal wire harness of the embolectomy support is provided with a developing ring, and the distal outer wall of the push rod, the proximal wire harness of the embolectomy support and the developing ring are connected into a whole through the proximal fixing sleeve.
Preferably, the distance between the developing ring and the proximal end of the thrombus removal support is 4 mm-5 mm.
Preferably, the guide head comprises an integrally formed:
an arcuate head having a distal diameter less than a proximal diameter;
the far end of the cylindrical connecting body is connected with the near end of the arc-shaped head, and the inside of the near end is connected with the far end of the pull tube and a far end wire harness of the embolectomy support;
the guide head is a hollow integrated structure with an opening at the near end, and a guide head through hole for passing through the guide wire penetrates through the guide head along the axial direction of the guide head.
Preferably, the guide head is made of one or more of PEBAX or PTFE high polymer materials.
Preferably, the wire harness is formed by mixing one or more metal materials of nickel-titanium alloy, platinum-iridium alloy or platinum-tungsten alloy;
the diameter range of the metal material is 0.10 mm-0.13 mm.
Preferably, the thrombus removal support is formed by weaving through a weaving machine, and the thrombus removal support with gradually sparse mesh density from the far end to the near end is obtained by adjusting the PPI value of the weaving machine gradually in a sectional interval manner;
the embolectomy support is a self-expansion metal support.
Preferably, the embolectomy support comprises:
at least two net disks integrally made of the wire harness and having meshes, being hollow inside, and being capable of assuming an expanded state or a contracted state;
the outer diameters of at least two net disks are the same, and the density of the net holes is gradually sparse from the far end to the near end;
the near end and the far end of each net disk are of a folded structure, a folded near-end wire harness is arranged at the near end, and a folded far-end wire harness is arranged at the far end.
According to a preferable scheme, a near-end wire harness and a far-end wire harness between two adjacent net disks are integrally connected to form a net disk connecting section after being shaped by a mold during heat shaping, an inter-ring inner fixing sleeve is sleeved outside the net disk connecting section, and the wire harnesses between the two adjacent net disks are integrally connected through the inter-ring inner fixing sleeve.
Preferably, the pushing rod passes through the central axes of at least two of the net disks, and the distal port of the pushing rod does not exceed the distal port of the most distal intra-annular fixing sleeve.
Preferably, the thrombectomy support further comprises:
at least two external bolt taking brackets which are integrally manufactured by the wiring harness and have meshes, are hollow inside and can be in an expansion state or a contraction state, and one external bolt taking bracket is sleeved outside the corresponding net disc;
the outer diameters of at least two adjacent external embolectomy supports are the same, the density of the meshes is gradually sparse from the far end to the near end, the density of the meshes on the external embolectomy supports is greater than that of the mesh discs at the same axial distance on the inner side, and the density of the meshes on the far end side of the external embolectomy support at the farthest end is denser than that of the meshes on the far end side of the corresponding mesh discs on the inner side;
the near end and the far end of each external embolectomy support are of a furled structure, a furled near end wire harness is arranged at the near end, a furled far end wire harness is arranged at the far end, the far end wire harness of each external embolectomy support is overlapped with the far end wire harness of each embolectomy support to cover the far end outer wall side of the pull tube, and the near end wire harness of each external embolectomy support is overlapped with the near end wire harness of each net disc to cover the far end outer wall side of the push rod.
Preferably, a fixed end of the proximal end harness of the outer tray when fixed to the distal end outer wall of the push rod is located outside the proximal end of the developing ring.
According to the preferable scheme, the near-end wire harness and the far-end wire harness between two adjacent outer disks are integrally connected to form an outer bolt taking support connecting section when the two adjacent outer disks are integrally manufactured, an inter-ring outer fixing sleeve is sleeved outside the outer bolt taking support connecting section, and the wire harnesses between the two adjacent outer disks are integrally connected through the inter-ring outer fixing sleeve.
Preferably, the embolectomy support further comprises:
the outer containing frame is integrally made of the wire harness, is provided with meshes, is hollow inside, can be in an expansion state or a contraction state, and is sleeved outside at least two mesh discs;
the outer diameter of the outer accommodating frame is not smaller than the outer diameter of the net disk, the density of meshes of the outer accommodating frame is gradually sparse from the far end to the near end, the density of the meshes on the outer accommodating frame is greater than that of the meshes on the net disk corresponding to the inner side, and the density of the meshes on the far end side of the outer accommodating frame is greater than that of the meshes on the far end side of the net disk corresponding to the inner side;
the near end and the far end of the outer containing frame are both of a furling structure, a furled near end wire harness is arranged at the near end, a furled far end wire harness is arranged at the far end, the far end wire harness of the outer containing frame and the far end wire harness of the net disc are overlapped, so that the far end wire harness of the bolt taking support is wrapped at the far end outer wall side of the pull tube, and the near end wire harness of the outer containing frame and the near end wire harness of the net disc are overlapped, so that the near end wire harness of the bolt taking support is wrapped at the far end outer wall side of the push rod.
Preferably, a fixed end of the proximal end harness of the outer housing bracket when fixed to the distal end outer wall of the push rod is located on a proximal end side of the developing ring.
Preferably, the fixed sleeve is connected with the guide head, the bolt taking support and the push rod in one or more modes of hot melt adhesion, barb connection, protruding barb connection and the like.
The positive progress effects of the invention are as follows: the invention adopts the thrombus extractor for the transcatheter pulmonary artery thrombus extraction system, and has the following advantages:
1. the thrombus taking bracket is simple and convenient to connect and fix by optimizing the connection relation between the thrombus taking bracket and the guide head, between the thrombus taking bracket and the pull tube, and the deformation problem of the thrombus taking bracket is greatly reduced, so that the thrombus taking bracket has a better expansion state, thrombus can be grabbed to the maximum extent, the thrombus can be gathered easily, and the contraction deformation is buffered when the thrombus withdraws, so that the loss of the thrombus is avoided;
2. the thrombus taking bracket with the mesh gradual change structure solves the problem that the existing bracket has low thrombus capture rate, synchronously reduces the probability of distal thrombus plugging caused by residual thrombus, and avoids secondary plugging caused by excessive thrombus leaving;
3. the thrombus taking support with the double-layer structure can well cut and grab thrombus when the thrombus taking support is in an expansion state, and can maximally collect the thrombus when the thrombus taking support is withdrawn, so that the risk of broken thrombus loss is reduced.
Drawings
FIG. 1 is a schematic structural diagram of the present invention;
FIG. 2 is a side perspective view of FIG. 1;
FIG. 3 is another side perspective view of FIG. 1;
FIG. 4 is a cross-sectional view of FIG. 1;
FIG. 5 is a schematic view of the present invention with the exception of the thrombectomy support;
FIG. 6 is a schematic view of a configuration of the pilot head of the present invention;
fig. 7 is a schematic view of the structure of the pouch of the present invention;
fig. 8 is another structural schematic view of the pouch of the present invention;
FIG. 9 is a schematic view of a construction of the tampon support of FIG. 1;
FIG. 10 is a side view of FIG. 9;
FIG. 11 is a schematic structural view of a double-layered thrombectomy stent of the present invention;
FIG. 12 is a side perspective view of FIG. 11;
FIG. 13 is a cross-sectional view of FIG. 11;
FIG. 14 is an enlarged view of a portion of FIG. 13;
FIG. 15 is a schematic view of a construction of the tampon support of FIG. 11;
FIG. 16 is a side view of FIG. 15;
FIG. 17 is a schematic view of another embodiment of a dual-layered embolic stent of the present invention;
FIG. 18 is a schematic view of a construction of the retrieval holder of FIG. 13;
FIGS. 19 and 20 are schematic views illustrating a process of thrombus taking by an embolectomy device of the present invention.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.
Referring to fig. 1 to 20, the thrombus remover for the transcatheter pulmonary artery thrombus removing system comprises a thrombus removing support 100, a guide head 200, a push rod 300, a pull tube 400 and a developing ring 500.
Referring to fig. 1-4, 9 and 10, the thrombectomy stent 100 is made of a wire bundle and has meshes that are a gradual structure with a dense distal end and a sparse proximal end.
In some embodiments, at least the proximal and distal ends of the embolectomy stent 100 are in a collapsed configuration, such that there is a collapsed proximal wire bundle at the proximal end and a collapsed distal wire bundle at the distal end.
In some embodiments, the wire harness is formed by mixing any one or more metal materials of nickel-titanium alloy, platinum-iridium alloy or platinum-tungsten alloy; the diameter range of the metal material is 0.10 mm-0.13 mm.
In some embodiments, when the stent 100 is manufactured, it is preferably knitted by a knitting machine, and the density of the mesh holes is gradually reduced from the distal end to the proximal end by adjusting the PPI value of the knitting machine gradually in a sectional interval.
In some embodiments, the thrombectomy stent 100 is a self-expanding metal stent, and the thrombectomy stent 100 is adjustably constrained from expanding or contracting by axial movement of the pull tube 400.
Referring to fig. 1-6, the guide head 200 is located at the distal end of the thrombectomy stent 100.
In some embodiments, the introducer head 200 includes an integrally formed curved head having a distal diameter that is less than a proximal diameter and a cylindrical connector body. The diameter of the cylindrical connecting body is the same as the diameter of the near end of the arc-shaped head, the far end of the cylindrical connecting body is connected with the near end of the arc-shaped head, the inside of the cylindrical connecting body is hollow, and the near end of the cylindrical connecting body is internally connected with the far end of the pull tube 400 and the far end wire harness of the embolectomy support 100. The guide head 200 is a hollow integral structure with a proximal opening, and a guide head through hole 210 for passing through a guide wire penetrates along the axial direction of the guide head 200.
In some embodiments, the guide head 200 is made of a blend of one or more of PEBAX or PTFE polymer materials.
Referring to fig. 1-4, the distal end of the push rod 300 is fixedly connected to the proximal end of the thrombectomy support 100, and the distal end of the push rod 300 is covered by the proximal wire harness of the thrombectomy support 100.
In some embodiments, the inner wall of the distal end of the push rod 300 covers the proximal wire harness of the embolectomy stent 100 and is connected as a whole by a proximal fixation sleeve.
Referring to fig. 4, in some embodiments, the proximal harness of the thrombectomy support 100 is provided with a visualization ring 500, and the outer wall of the distal end of the pushing rod 300, the proximal harness of the thrombectomy support 100 and the visualization ring 500 are connected together through a proximal fixing sleeve.
In some embodiments, the developer ring 500 is positioned between 4mm and 5mm from the proximal end of the thrombectomy support 100.
Referring to fig. 1 to 5, the pull tube 400 is located inside the thrombectomy support 100, the proximal end of the pull tube 400 passes through the thrombectomy support 100 and extends to the operation end of the external thrombectomy system, the distal end of the pull tube 400 is fixedly connected to the guide head 200, and the pull tube 400 is a piston-type pull tube; when the pull tube 400 moves axially, the thrombectomy support 100 and the guide head 200 are driven.
In some embodiments, the pull tube 400 is a piston pull tube 400 made of a mixture of one or more of PEBAX or PTFE polymer materials.
In some embodiments, the two ends of the pull tube 400 are provided with a necking for connection, the diameter of the necking is between the minimum outer diameter of the pull tube 400 and the minimum inner diameter of the push rod 300, and the necking is fixedly connected to the inside of the far end of the push rod 300.
In some embodiments, the diameter of the throat is preferably 1.41mm to 1.45mm, and the axial length of the throat is 2mm to 3 mm.
In some embodiments, the pull tube 400 is coaxial with the thrombectomy stent 100, and the pull tube 400 limits expansion or contraction of the thrombectomy stent 100.
In some embodiments, the distal end of the pull tube 400 extends beyond the distal end of the embolic stent 100 a distance of 5mm to 20mm, preferably 12mm to 18mm, and more preferably 13mm to 15 mm.
In some embodiments, the outer wall of the distal end of the pull tube 400 is covered by the distal wire bundle of the embolectomy stent 100 and then fixedly connected together inside the proximal end of the guide head 200.
In some embodiments, the outer wall of the distal end of the pull tube 400 is integrally connected to the distal wire harness of the embolectomy support 100 by a distal fixing sleeve, and the outer surface of the distal fixing sleeve is connected to the inside of the proximal end of the guiding head 200, so that the outer wall of the distal end of the pull tube 400, the distal wire harness of the embolectomy support 100 and the guiding head 200 are integrally connected by the distal fixing sleeve.
In some embodiments, the proximal or distal fixation sleeves as fixation sleeves are connected to the guide head 200, the thrombectomy support 100, the push rod 300 by one or more of thermal fusion bonding, barbed connection, and the like.
In some embodiments, referring to fig. 7, a plurality of rows of barbs are uniformly distributed on the inner wall of the fixing sleeve, and the fixing sleeve is connected through the barbs.
In some embodiments, referring to fig. 8, a plurality of rows of spikes are uniformly distributed on the inner wall of the fixing sleeve, and the fixing sleeve is connected by the spikes.
The working principle of the invention is as follows: the pull tube 400 is fixedly connected with the guide head 200, the far end of the pull tube 400 penetrates through the thrombus taking support 100, the near end of the pull tube 400 penetrates through the push rod 300 to the operation end of the thrombus taking system, the push rod 300 is pushed to enable the thrombus taking support 100 to be separated from the inner catheter sheath 710 to recover to a free state, and the pull tube 400 is pulled to control the relative extension of the thrombus taking support 100 to enable the thrombus taking support 100 to be more attached to the inner wall of a blood vessel; when the thrombus is collected, the push rod 300 is pulled, so that the guide head 200 is contracted to the distal port of the inner catheter sheath 710, and the thrombus remover can collect the thrombus as much as possible through stretching and contracting for many times to achieve the purpose of collecting or removing the thrombus to the outer catheter sheath. And after the thrombus is collected, withdrawing the thrombus taking system. In the use process of the invention, the pull tube 400 is used for axial guidance of the embolectomy support 100 and preventing the embolectomy support 100 from being stuck relative to the inner catheter sheath 710 in the process of collecting the embolectomy support 100 by the push rod 300; the closing and releasing of the embolectomy bracket are controlled by the pushing rod 300.
In some embodiments, referring to fig. 1-4 and 9-10, the embolectomy stent 100 comprises at least two mesh discs 110, wherein the at least two mesh discs 110 are integrally made of warp bundles and have meshes, the inside of the mesh discs 110 is hollow, and the mesh discs 110 can be in an expanded state or a contracted state. The outer diameters of at least two of the mesh disks 110 are the same and the mesh holes are gradually sparse in density from the distal end to the proximal end. The proximal and distal ends of each mesh tray 110 are in a collapsed configuration, with each mesh tray 110 having a collapsed proximal bundle at the proximal end and each mesh tray 110 having a collapsed distal bundle at the distal end.
In some embodiments, as shown in fig. 9, there are three mesh disks 110, from proximal to distal, mesh disk 111, mesh disk 112, and mesh disk 113, respectively. The proximal wire harness of the net disc 111 is coated on the outer wall of the distal end of the pushing rod 300 as the proximal wire harness of the embolectomy support 100, and is preferably connected into a whole through a proximal fixing sleeve. The distal end wire harness of the net disk 113 is coated on the distal outer wall of the pull tube 400 as the distal end wire harness of the embolectomy support 100, and is preferably fixedly connected with the proximal end inside of the guide head 200 through a distal end fixing sleeve.
In some embodiments, referring to fig. 1 and 5, the proximal wire harness and the distal wire harness between two adjacent mesh disks 110 are integrally connected to form a mesh disk connection section after being shaped by a mold during thermoforming, an inter-ring fixing sleeve 610 is sleeved outside the mesh disk connection section, and the wire harnesses between two adjacent mesh disks 110 are integrally connected through the inter-ring fixing sleeve 610. When the net disks 110 are multiple and have self-expanding structures, the net disks are easy to deform during releasing and retracting processes, the deformation is large, and in order to control the deformation, the inter-ring inner fixing sleeve 610 is additionally arranged between every two adjacent net disks 110 to define the inner diameter size between the net disks 110, so that the net disks 110 can be well expanded during releasing, and the net disks 110 can be well retracted into the inner catheter sheath 710 during retracting.
In some embodiments, the intra-annular fixation sleeve 610 is connected to the proximal fixation sleeve or the distal fixation sleeve in the same manner, and the intra-annular fixation sleeve 610 is connected to the mesh plate connection section in one or more of thermal fusion bonding, barb connection, spike connection, and the like.
In some embodiments, the distal end of the push rod 300 is fixedly connected to the inside of the embolectomy support 100, so that when the embolectomy support 100 has a plurality of mesh discs 110, the push rod 300 passes through the central axis of at least two of the mesh discs, the distal end of the push rod 300 is fixedly connected through the proximal middle portion of the most proximal mesh disc 110 and the distal port of the push rod 300 does not exceed the distal port of the most distal intra-annular retainer 610.
In some embodiments, as shown in fig. 1 and 9, there are three mesh disks 110, from proximal to distal, mesh disk 111, mesh disk 112, and mesh disk 113, respectively. An inter-ring inner fixing sleeve 610 is sleeved between the net disk 111 and the net disk 112 and between the net disk 112 and the net disk 113.
In use, referring to fig. 19 and 20, the thrombus taking device reaches and exceeds the far end of the target thrombus 800 through the outer catheter sheath 720 channel established by the delivery system in the pulmonary artery thrombus taking system, and then releases the thrombus taking support 100, the three mesh discs 110 self-expand to fill the blood vessel, and the mesh discs 110 are attached to the blood vessel wall 900; then, the proximal part of the pushing rod 300 is held by hand and slowly pulled in the proximal direction along the axial direction until the thrombus 800 is captured and pulled into the channel of the outer catheter sheath 720 by the thrombus taking support 100.
The density of the net disk 111 at the most proximal end is sparsest, the radial supporting force in the process of withdrawing the outer catheter sheath 720 is relatively small, and the contraction and deformation of the net disk 112 in the middle are buffered in the process of withdrawing; the weaving density of the middle net disk 112 is moderate, which is suitable for capturing thrombus, but the thrombus is inevitably damaged in the gathering and withdrawing process; the density of the net disc 113 at the farthest end is compact, the PPI setting is high, thrombus fragments formed by cutting and breaking in the process of collecting thrombus by the net disc 112 in the middle and withdrawing the outer catheter sheath 720 can be caught to the maximum extent by the high-density net disc 113 at the farthest end, the risk of breaking thrombus to form a far-end embolism is reduced, the frequency of repeatedly drawing and withdrawing the thrombus by the thrombus extractor is synchronously reduced, and the injury to blood vessels is relieved.
In some embodiments, referring to fig. 11-16, the thrombectomy stent 100 further comprises at least two external thrombectomy stents 120, wherein the external thrombectomy stents 120 are integrally formed by bundles of warp threads and have meshes, the internal portion of the external thrombectomy stents 120 is hollow, the external thrombectomy stents 120 can be in an expanded state or a contracted state, and one external thrombectomy stent 120 is sleeved outside a corresponding one of the mesh discs 110. At least two adjacent external embolectomy stents 120 have the same outer diameter and gradually sparse meshes from the far end to the near end, the density of the meshes on the external embolectomy stents 120 is greater than that of the meshes on the internal side of the coaxial-axial-distance mesh plates 110, and the density of the meshes on the far end side 120a of the outermost external embolectomy stent 120 is denser than that of the meshes on the far end side 110a of the internal side corresponding mesh plate 110.
The near end and the far end of each external embolectomy support 120 are of a furled structure, a furled near end wire harness is arranged at the near end, a furled far end wire harness is arranged at the far end, the far end wire harness at the far end in each external embolectomy support 120 and the far end wire harness at the far end in the net disc 110 are overlapped, so that the far end wire harness of each embolectomy support 100 is covered on the far end outer wall side of the pull tube 400, and the near end inside of the guide head 200 can be fixedly connected together through a far end fixing sleeve. The proximal wire harness at the most proximal end in the external embolectomy support 120 is overlapped with the proximal wire harness at the most proximal end in the net disc 110, so that the proximal wire harness of the embolectomy support 100 is coated on the far-end outer wall side of the push rod 300 and can be connected into a whole through a proximal fixing sleeve.
In some embodiments, the proximal-most wire bundle of the external embolectomy holder 120 is fixed to the distal outer wall of the push rod 300 at a fixed end located outside the proximal end of the developer ring 500.
In some embodiments, referring to fig. 13 and 14, the proximal end wire harness and the distal end wire harness between two adjacent external embolus stents 120 are integrally connected to form an external embolus stent connecting section after being shaped by a mold during heat setting, and obviously, the external embolus stent connecting section has an outer diameter no less than that of the net disk connecting section, so that one external embolus stent 120 can be correspondingly sleeved on one net disk 110. An inter-ring outer fixing sleeve 620 is sleeved outside the connecting section of the outer bolt taking bracket, and the wire harnesses between two adjacent outer bolt taking brackets 120 are connected into a whole through the inter-ring outer fixing sleeve 620.
In some embodiments, the external fixation ring 620 is connected to the proximal or distal fixation ring in the same manner, and the external fixation ring 620 is connected to the mesh plate connection section in one or more of a thermal fusion bonding, a barb connection, a spike connection, and the like. As shown in fig. 14, the outer ring fixing sleeve 620 is connected to the outer bolt-removing bracket connecting section by means of a spur connection, and the inner ring fixing sleeve 610 is connected to the net disk connecting section by means of a spur connection.
In some embodiments, referring to fig. 17 and 18, the embolectomy support 100 further comprises an outer containing frame 130, the outer containing frame 130 is integrally formed by a bundle of warp threads and has a mesh, the outer containing frame 130 is hollow inside, the outer containing frame 130 can be in an expanded state or a contracted state, and the outer containing frame 130 is sleeved outside the at least two mesh discs 110. The outer receiving frame 130 receives a plurality of mesh trays 110 therein.
The outer diameter of the outer holding frame 130 is not less than the outer diameter of the net disk 110, and the mesh density of the outer holding frame 130 gradually decreases from the distal end to the proximal end, the mesh density on the outer holding frame 130 is greater than the mesh density on the inner side corresponding net disk 110, and the mesh density on the distal end side 130a of the outer holding frame 130 is greater than the mesh density on the distal end side 110a of the inner side corresponding net disk 110.
The near end and the far end of the outer containing frame 130 are both of a furled structure, a furled near end wire harness is arranged at the near end of the outer containing frame 130, a furled far end wire harness is arranged at the far end of the outer containing frame 130, the far end wire harness of the outer containing frame 130 and the far end wire harness at the far end in the net disc 110 are overlapped to cover the far end wire harness of the bolt taking support 100 outside the far end outer wall of the pull tube 400, and the near end inside of the guide head 200 can be fixedly connected together through a far end fixing sleeve. The proximal wire harness of the outer containing frame 130 is overlapped with the proximal wire harness of the net disc 110, so that the proximal wire harness of the embolectomy support 100 is covered outside the outer wall of the far end of the pushing rod 300 and can be connected into a whole through a proximal fixing sleeve.
In some embodiments, the fixed end of the proximal harness of the outer receiving rack 130 when fixed on the distal outer wall of the push lever 300 is located at the proximal side of the developing ring 500.
The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (22)
1. A thrombus extractor for a ducted pulmonary artery thrombus extraction system comprises a thrombus extraction bracket; a guide head located at the distal end of the thrombectomy support;
the thrombus taking support is made of a wire harness and is provided with meshes, and the meshes are of a gradient structure with a dense far end and a sparse near end;
further comprising:
the far end of the pushing rod is connected to the near end of the embolectomy support, and the pushing rod is coated on a near end wire harness of the embolectomy support;
the pulling tube is positioned inside the embolectomy support, the near end of the pulling tube penetrates through the embolectomy support and extends to the operation end of the embolectomy system, the far end of the pulling tube is fixedly connected with the guide head, and the pulling tube is a piston type pulling tube;
and when the pull pipe moves axially, the plug taking support and the guide head are driven.
2. The embolectomy device of claim 1, wherein the pull tube is provided with a necking at two ends for connection, the diameter of the necking is between the minimum outer diameter of the pull tube and the minimum inner diameter of the push rod, and the necking is fixedly connected to the inside of the distal end of the push rod.
3. The embolectomy device of claim 2, wherein the pull tube is coaxial with the embolectomy stent, and the pull tube limits expansion or contraction of the embolectomy stent.
4. The embolectomy device of claim 3 wherein the diameter of the constriction is 1.41mm to 1.45mm, and the axial length of the constriction is 2mm to 3 mm.
5. The embolectomy device of claim 3 wherein the distal outer wall of the pull tube and the distal wire bundle of the embolectomy stent are integrally connected by a distal retaining sleeve, and the outer surface of the distal retaining sleeve is connected to the inner proximal portion of the guiding head, such that the distal outer wall of the pull tube, the distal wire bundle of the embolectomy stent and the guiding head are integrally connected by the distal retaining sleeve.
6. The embolectomy device of claim 5, wherein the distal end of the pull tube extends beyond the distal end of the embolectomy stent by a distance of 5mm to 20mm, preferably 12mm to 18mm, and more preferably 13mm to 15 mm.
7. The embolectomy device of claim 2, wherein the distal inner wall of the pushing rod covers the proximal wire bundle of the embolectomy stent and is connected with the proximal fixing sleeve into a whole.
8. The embolectomy device of claim 7 wherein the proximal wire bundle of the embolectomy support is provided with a visualization ring, and the outer wall of the distal end of the push rod, the proximal wire bundle of the embolectomy support and the visualization ring are integrally connected by the proximal fixing sleeve.
9. The embolectomy device of claim 8 wherein the proximal end of the visualization ring and the embolectomy stent are separated by a distance of 4mm to 5 mm.
10. The embolectomy device of claim 1 wherein the introducer head comprises an integrally formed:
an arcuate head having a distal diameter less than a proximal diameter;
the far end of the cylindrical connecting body is connected with the near end of the arc-shaped head, and the inside of the near end is connected with the far end of the pull tube and a far end wire harness of the embolectomy support; the guide head is a hollow integrated structure with an opening at the near end, and a guide head through hole for passing through the guide wire penetrates through the guide head along the axial direction of the guide head.
11. The embolectomy device of claim 1, wherein the wire bundle is a mixture of one or more metallic materials selected from nitinol, platiniridium, and platinitungetal;
the diameter range of the metal material is 0.10 mm-0.13 mm.
12. The embolectomy device of claim 11, wherein the embolectomy stent is woven by a knitting machine, and the density of the meshes of the embolectomy stent is gradually reduced from the distal end to the proximal end by adjusting the PPI value of the knitting machine in a stepwise interval;
the embolectomy support is a self-expansion metal support.
13. The embolectomy device of any of claims 1-12, wherein the embolectomy stent comprises:
at least two net disks integrally made of the wire harness and having meshes, being hollow inside, and being capable of assuming an expanded state or a contracted state;
the outer diameters of at least two net disks are the same, and the density of the net holes is gradually sparse from the far end to the near end;
the near end and the far end of each net disk are of a folded structure, a folded near-end wire harness is arranged at the near end, and a folded far-end wire harness is arranged at the far end.
14. The embolectomy device of claim 13 wherein the proximal and distal end strands between two adjacent mesh discs are integrally connected to form a mesh disc connecting section after being shaped by a mold during heat setting, the mesh disc connecting section is sleeved with an inter-ring internal fixation sleeve, and the strands between two adjacent mesh discs are integrally connected through the inter-ring internal fixation sleeve.
15. The embolectomy device of claim 14 wherein the push rod passes through the central axis of at least two mesh discs, and the distal port of the push rod does not exceed the distal port of the distal-most intra-annular fixation sleeve.
16. The embolectomy device of claim 13, wherein the embolectomy stent further comprises:
at least two external bolt taking brackets which are integrally manufactured by the wiring harness and have meshes, are hollow inside and can be in an expansion state or a contraction state, and one external bolt taking bracket is sleeved outside the corresponding net disc;
the outer diameters of at least two adjacent external embolectomy supports are the same, the density of the meshes is gradually sparse from the far end to the near end, the density of the meshes on the external embolectomy supports is greater than that of the mesh discs at the same axial distance on the inner side, and the density of the meshes on the far end side of the external embolectomy support at the farthest end is denser than that of the meshes on the far end side of the corresponding mesh discs on the inner side;
the near end and the far end of each external embolectomy support are of a furled structure, a furled near end wire harness is arranged at the near end, a furled far end wire harness is arranged at the far end, the far end wire harness of each external embolectomy support is overlapped with the far end wire harness of each embolectomy support to cover the far end outer wall side of the pull tube, and the near end wire harness of each external embolectomy support is overlapped with the near end wire harness of each net disc to cover the far end outer wall side of the push rod.
17. The embolectomy device of claim 16 wherein when the proximal wire bundle of the embolectomy stent is sheathed with a visualization ring, the fixed end of the proximal wire bundle of the most proximal of the outer embolectomy stents when fixed to the outer wall of the distal end of the pusher rod is located outside the proximal end of the visualization ring.
18. The embolectomy device of claim 16 wherein the proximal and distal end strands between two adjacent external embolectomy stents are integrally connected when integrally manufactured to form an external embolectomy stent connecting section, the external embolectomy stent connecting section is externally sleeved with an external annular fixation sleeve, and the strands between two adjacent external embolectomy stents are integrally connected by the external annular fixation sleeve.
19. The embolectomy device of claim 13, wherein the embolectomy stent further comprises:
the outer containing frame is integrally made of the wire harness, is provided with meshes, is hollow inside, can be in an expansion state or a contraction state, and is sleeved outside at least two mesh discs;
the outer diameter of the outer accommodating frame is not less than the outer diameter of the net disk, the density of meshes of the outer accommodating frame is gradually sparse from the far end to the near end, the density of the meshes of the outer accommodating frame is greater than that of the meshes of the net disk corresponding to the inner side, and the density of the meshes of the outer accommodating frame on the far end side is greater than that of the meshes of the net disk corresponding to the inner side;
the near end and the far end of the outer containing frame are both of a furling structure, a furled near end wire harness is arranged at the near end, a furled far end wire harness is arranged at the far end, the far end wire harness of the outer containing frame and the far end wire harness of the net disc are overlapped, so that the far end wire harness of the bolt taking support is wrapped outside the far end outer wall of the pull tube, and the near end wire harness of the outer containing frame and the far end wire harness of the net disc are overlapped, so that the near end wire harness of the bolt taking support is wrapped on the far end outer wall side of the push rod.
20. The embolectomy device of any of claims 1-19, wherein the fixation sheath is attached to the guide head, the embolectomy stent, and the pushing rod by one or more of heat-fusion bonding, barb connection, spike connection, etc.
21. The embolectomy device of claim 19 wherein when the proximal wire bundle of the embolectomy stent is sheathed with a visualization ring, the fixed end of the proximal wire bundle of the outer containment frame when fixed on the outer wall of the distal end of the pushing rod is located at the proximal side of the visualization ring.
22. The embolectomy device of claim 1 wherein the pull tube is a mixture of one or more of PEBAX or PTFE polymer materials;
the guide head is made of one or a mixture of PEBAX and PTFE high polymer materials.
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