CN111407461A

CN111407461A - Thrombus filtering device for operation

Info

Publication number: CN111407461A
Application number: CN202010182346.3A
Authority: CN
Inventors: 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2020-03-16
Filing date: 2020-03-16
Publication date: 2020-07-14

Abstract

The invention relates to the technical field of medical instruments, in particular to a thrombus filtering device for operation, which comprises a filtering layer, a filtering layer supporting frame, a fixed support and a control wire; the filter layer support frame is ship-shaped and is used for supporting in a blood vessel; the filter layer is covered on the filter layer bracket and is used for filtering thrombus; the fixing supports comprise a plurality of fixing supports which are respectively fixed on different sides of the filtering layer support frame so as to support the stable support of the vessel wall auxiliary filtering layer support frame; the plurality of fixing supports are respectively connected with a control wire, and the control wires are used for pulling the fixing supports to adjust the positions of the fixing supports. The thrombus filtering device for the operation can be conveniently and stably placed at a preset position of a blood vessel by an operator, and can be adjusted when the placing position is not proper, so that the operation difficulty is reduced, and the success rate of the operation is improved.

Description

Thrombus filtering device for operation

Technical Field

The invention relates to the technical field of medical instruments, in particular to a thrombus filtering device for an operation.

Background

In vascular interventional therapy and valve repair surgery, almost all patients have release of thrombus-causing substances at stenotic lesions or cause shedding of fine tissues during valve repair, and can cause embolism of far ends of blood vessels, so that perfusion of far ends of blood vessels is obstructed. After successful treatment, lipid fragments, matrix components, endothelial cells, inflammatory cells, platelets, leukocyte adhesion and the like in the plaque can form embolism, enter a far-end blood vessel along the direction of blood flow, and block the blood supply of important organs, such as brain and heart and other important organs, so that the immediate or long-term prognosis of a patient is influenced. A thrombus filtration device is a system that can filter out thrombus or plaque. The success rate of the operation can be greatly improved after the thrombus filtering device is used, and the prior art, for example, the patent document with the application number of 201721320118.8 discloses a thrombus protection device. It sets up in intravascular preset position department for filter the thrombus, thrombus protector includes skeleton and filter screen, the skeleton will the filter screen support in intravascular preset position department, the filter screen can filter the thrombus. The skeleton includes the main frame and with first supporting part and the second supporting part that the main frame links to each other, first supporting part and the second supporting part to the different lateral parts of main frame extend, the main frame first supporting part and the second supporting part be used for respectively laminating in on the inner wall of different positions of blood vessel department. When the structure of the stent adopts common memory alloy, the stent is difficult to place in the process of releasing and recovering the deformation in the operation, so that the placement position is unreasonable, the stent can not effectively support the framework to resist the blood flow impact, and even the dislocation applies excessive pressure to the blood vessel to cause additional damage to the blood vessel.

In view of the above technical problems, it is desirable to improve.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a thrombus filtering device for operation.

In order to achieve the purpose, the invention adopts the following technical scheme:

a thrombus filtering device for operation comprises a filtering layer, a filtering layer supporting frame, a fixing bracket and a control wire; the filter layer support frame is ship-shaped and is used for supporting in a blood vessel; the filter layer is covered on the filter layer bracket and is used for filtering thrombus; the fixing supports comprise a plurality of fixing supports which are respectively fixed on different sides of the filtering layer support frame so as to support the stable support of the vessel wall auxiliary filtering layer support frame; the plurality of fixing supports are respectively connected with a control wire, and the control wires are used for pulling the fixing supports to adjust the positions of the fixing supports.

According to a preferable scheme, the filter layer supporting frame is provided with a wire control support, and the wire control support is used for enabling a wire to be threaded and wound to change the tension direction of the wire control.

Preferably, the abutting end of the fixed stent and the vessel wall is provided with grains so as to increase the friction force.

Preferably, the filter layer is a multi-layer filter layer structure.

Preferably, the multi-layer filter layer comprises filter layers with different filter precisions, the material of the multi-layer filter layer comprises one or a combination of a filter screen and a filter membrane, and the filter layer is loaded with one or more medicines.

Preferably, each filter layer of the multi-layer filter layer is connected with a screen changing wire, and the screen changing wire is used for pulling the connected filter layer to be peeled from the multi-layer filter layer.

As a preferred scheme, the number of the fixing supports is two, the fixing supports are in a splayed shape and comprise an upper fixing support and a lower fixing support which are respectively fixed on two sides of the middle part of the filter layer supporting frame; the top of the splayed upper fixing support and the top of the splayed lower fixing support are respectively connected with respective control wires, and the bottoms of the splayed upper fixing support and the splayed lower fixing support are respectively connected to two sides of the middle part of the filter layer supporting frame.

Preferably, the wire control bracket is arranged at the end part of the filter layer bracket, the wire control bracket is 8-shaped, and the wires of the upper fixing bracket and the lower fixing bracket respectively pass through two 8-shaped ring parts of the wire control bracket and are folded back to the other end of the filter layer bracket.

Preferably, the filter layer supporting frame is composed of 2-10 elastic memory material wires, and the elastic memory material wires are composed of one or more of nickel titanium wires, stainless steel wires, polyurethane, polylactic acid and copolymerization modification thereof, carbon fibers, glass fibers and Kevlar fibers; the connection mode of the filter layer support frame and the fixing support comprises any one of welding, integral forming and fixing piece connection.

Preferably, the wire diameter of the wire control is less than 0.1mm, and the wire control is made of one or a combination of more of nickel-titanium alloy wires, stainless steel wires, carbon fibers and glass fibers.

Compared with the prior art, the thrombus filtering device can be conveniently and stably placed at a preset position of a blood vessel by an operator, can be adjusted when the placing position is not proper, can effectively filter thrombus by the multiple filtering layers, can replace the filtering layers of the filtering layers in the operation process, reduces the operation difficulty, and improves the success rate of the operation.

Drawings

FIG. 1 is a schematic structural diagram of a thrombus filter device for surgery according to a first embodiment of the present invention;

FIG. 2 is a front view of a thrombus filter device for surgery according to a first embodiment of the present invention;

FIG. 3 is a schematic view of a blood vessel at the aortic arch where a thrombus filter device for operation according to a first embodiment of the present invention is placed;

FIG. 4 is a schematic view of the aortic arch with the thrombus filter device according to the first embodiment of the present invention;

FIG. 5 is a schematic view showing a filter layer of a thrombus filter device for operation according to a second embodiment of the present invention, the filter layer being made of a filter membrane;

FIG. 6 is a schematic structural view of a filter layer support frame for surgery according to a third embodiment of the present invention, which is connected to a fixing frame in the form of a steel sleeve;

FIG. 7 is a schematic view showing a structure of a filter layer of a thrombus filter device for operation according to a fourth embodiment of the present invention, which is a multi-layer filter layer;

FIG. 8 is a schematic structural view of a thrombus filter device for surgery according to a fifth embodiment of the present invention;

wherein: 100. a thrombus filtration device; 101. a filter layer support frame; 102. an upper fixing bracket; 103. a lower fixed bracket; 104. a screen having pores less than 0.15 square millimeters; 105. controlling the filaments; 106.8-shaped circular rings; 107. a sheath tube; 108. the connecting part of the fixed bracket and the filter layer supporting frame; 109. thrombosis; 110. innominate artery; 111. the left common carotid artery; 112. the left subclavian artery; 113. the blood flow; 114. changing the mesh; 115. and (5) steel sleeve.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It is to be noted that the features in the following embodiments and examples may be combined with each other without conflict.

The first embodiment is as follows:

as shown in FIGS. 1 to 4, the thrombus filter device 100 of the present embodiment is applied to filtering of thrombus 109 during a surgical procedure, and in a specific implementation, the thrombus filter device 100 is delivered to a preset position of a blood vessel by a sheath 107 and pushed out to be fixed. The thrombus filtering device 100 comprises a filtering layer, a filtering layer support frame 101, a fixing support and a control wire 105, wherein the filtering layer support frame 101 is ship-shaped and is used for being supported in a blood vessel; the filter layer is covered on the filter layer bracket and is used for filtering thrombus 109; the fixed supports comprise a plurality of fixed supports which are respectively fixed on different sides of the filter layer support frame 101 so as to support against the stable support of the vessel wall auxiliary filter layer support frame 101; the plurality of fixing supports are respectively connected with a wire control 105, and the wire control 105 is used for pulling the fixing supports to adjust the positions of the fixing supports.

Specifically, the filter layer support frame 101 is composed of four elastic memory material wires, the four elastic memory material wires are gathered together at the front end of the device, then are separated along the direction of the tail end, then are gathered together, and finally are gathered together, the whole shape support frame is in a ship-like shape, more specifically, the device can be better matched with a blood vessel in order to have deformation in a certain shape, the filter layer support frame 101 has certain rigidity so that the filter layer support frame can be completely unfolded, and the material of the filter layer support frame 101 is made of a memory material nickel-titanium alloy wire, so that the filter layer support frame can recover and keep the original shape in a certain temperature range; preferably, the filter layer supporting frame 101 may be made of 2, 3, 5-10 or more elastic memory material wires, the structure may be a net-shaped telescopic type or a vertical-row fence type, and the elastic memory material wires are made of one or more of stainless steel wires, polyurethane, polylactic acid and its copolymer modification, carbon fibers, glass fibers, and Kevlar fibers.

The number of the fixed brackets is two, the shape of the fixed brackets is in a splayed shape, the left-off part of the splayed shape is the bottom, the folding part of the splayed shape is the top, and the fixed brackets comprise an upper fixed bracket 102 and a lower fixed bracket 103 which are respectively fixed on two sides of the middle part of the filter layer supporting frame 101; the splayed tops of the upper fixing support 102 and the lower fixing support 103 are respectively connected with respective control wires 105, the bottoms of the upper fixing support and the lower fixing support are respectively connected to two sides of the middle part of the filter layer support 101, the fixing supports and the filter layer support 101 are made of the same material, for example, the same nickel-titanium alloy wires are selected, two nickel-titanium alloy wires are bent to form two fixing supports, and the connecting parts 108 of the fixing supports and the filter layer support are welded and connected or integrally formed by the same material. Preferably, the abutting end of the fixing support and the vessel wall is provided with grains to increase friction force, namely, the splayed top of the fixing support frame is provided with patterns to increase friction force, so that the device can be placed more firmly.

The splayed tops of the upper fixing support 102 and the lower fixing support 103 are respectively connected with respective wire control 105, and the wire control 105 removes the memory elasticity of the fixing support through the external pulling of the sheath 107, so that the angle and position adjustment of the fixing support can be effectively carried out; preferably, a wire control 105 support is arranged on the filter layer support frame 101, the pulling force direction of the wire control 105 can be changed by threading the wire control 105 through the wire control 105 support, for example, a 8-shaped ring 106 is arranged at the end of the filter layer support, the wires control 105 of the upper fixing support 102 and the lower fixing support 103 respectively pass through two 8-shaped ring parts of the wire control 105 support and are folded back to the other end of the filter layer support to pass through a sheath tube 107, the pulling direction of the wire control 105 can be changed, the elastic restoring force in different directions of the fixing supports or better direct connection of each support with a plurality of wires control 105 is realized, the plurality of wires control 105 are matched with the wire control 105 supports in different directions to provide the pulling force in different directions, and the position adjustment can be carried out from different directions. Preferably, the filament control 105 support may be a plurality of rings distributed on the filter layer support, or a ring with a notch, and the notch pulls the filament control 105 out of the notch when the operation is completed. Preferably, the operation wound is reduced, the wire diameter of the wire control 105 is controlled to be less than 0.1mm, in order to improve the operation precision, the wire control 105 is preferably made of an inelastic material, the material of the wire control 105 is formed by one or a combination of more of nickel-titanium alloy wires, stainless steel wires, carbon fibers and glass fibers, and the nickel-titanium alloy wires, the stainless steel wires or silk threads made of high polymer materials can be adopted. Preferably, the multiple filaments 105 are color or text coded to distinguish the different filaments 105.

The filter layer is used for filtering the thrombus 109, for example, a filter screen 104 with pores smaller than 0.15 square millimeter is selected, the filter screen is woven by nickel-titanium wires or implantable stainless steel wires or threads made of high polymer materials, the filter screen is fixed on the filter layer support frame 101 in a sewing mode, and one or more medicines can be coated or wrapped on the filter screen to reduce the formation of the thrombus 109.

Embodiments and methods of use of the thrombus filter device 100:

in the embodiment, the thrombus filter device 100 is placed at the aortic arch shown in fig. 3 and 4, and the thrombus 109 is not normally present in the blood, and the blood flows from the innominate artery 110, the left common carotid artery 111, and the left subclavian artery 112 to the vital organs of the human body. When thrombus 109 exists in blood as shown in fig. 3, the thrombus 109 may enter important organs of the human body through innominate artery 110, left common carotid artery 111 and left subclavian artery 112, causing serious injury to the human body.

When the device is adopted, the thrombus 109 can be effectively prevented from entering important organs of a human body, so that the human body is seriously damaged. When the thrombus filtering device 100 is used, the sheath 107 conveys the thrombus filtering device 100 to the aortic arch, then the device is pushed out from the sheath 107, the filtering layer support frame 101 is formed by a shape memory material nickel titanium alloy wire and is unfolded into the former shape, the filtering layer support frame 101 is unfolded to unfold the filter net sewed on the filtering layer support frame, and the upper fixing support frame 103 and the lower fixing support frame are unfolded at the same time. The thrombus filtration device 100 is adjusted so that the figure-of-eight ring is attached to the blood vessel wall. The position of the upper fixing stent 102 is adjusted by pulling the wire control 105 of the upper fixing stent 102, so that the upper fixing stent 102 is positioned between the innominate artery 110 and the left common carotid artery 111, the top end of the upper fixing stent 102 is positioned between the innominate artery 110 and the left common carotid artery 111 under the action of elasticity, and the lines at the head end of the upper fixing stent 102 increase the friction force to ensure that the fixation is more stable. And then the position of the lower fixing support 103 is adjusted by pulling the control wire 105, so that the lower fixing support 103 is propped against the inner wall of the aortic arch, and the patterns at the top end of the lower fixing support 103 enable the fixation to be more stable. The thrombus filter device 100 can be stably fixed at the aortic arch under the impact of the blood flow 113 through the support of four points, and can effectively prevent the thrombus 109 formed in the operation process from flowing to important organs of the human body. After the operation is completed, the upper and lower fixed supporting frames are retracted by adjusting the control wire 105, and then the thrombus filtering device 100 is withdrawn, and the thrombus 109 formed in the operation process is taken out of the body.

The thrombus filtering device 100 of the embodiment can be beneficial to an operator to place the thrombus filtering device at a preset position of a blood vessel stably and quickly, and can be adjusted when the position of the thrombus filtering device is not proper, so that the operation difficulty is reduced, and the success rate of the operation is improved.

Example two:

the thrombus filter device for surgery of the present embodiment is different from the first embodiment in that:

as shown in fig. 5, the filter layer in this embodiment does not adopt a filter screen structure woven by various materials, but adopts a filter membrane with a membrane structure with good filtering performance, and the filter membrane may be a microporous filter membrane or a spun-yarn membrane material.

Compared with the first embodiment, the structure of the filter membrane is easier to be used as a carrier of the medicine, and smaller thrombus can be filtered. Preferably, the filtering layer can also adopt a combination of a filter screen and a filter membrane to exert respective material advantages.

Other structures refer to the first embodiment.

Example three:

as shown in FIG. 6, the upper and lower fixing brackets in this embodiment are not connected with the filter layer support frame by welding, but are connected by fixing the fixing members by means of steel sleeves 115. Compared with the first connection mode using the steel sleeve 115, the first connection mode avoids the technical difficulty that nickel-titanium alloy is difficult to weld, and connection is more convenient and faster. Preferably, the fixing part can be made of other materials or structures.

Other structures refer to the first embodiment.

Example four:

as shown in fig. 7, the filter layer in this embodiment is composed of three layers, the lowest layer is a small-pore mesh, the middle layer is a medium-pore mesh, and the highest layer is a large-pore mesh, so that the filtering effect can be enhanced by stage filtering through multiple filter layers with different filtering precisions. Preferably, the filter layer may have two or more layers.

Other structures refer to the first embodiment.

Example five:

the thrombus filter device for surgery of the present embodiment is different from the fourth embodiment in that:

as shown in fig. 8, each filtering layer of the multiple filtering layers is connected with a mesh changing wire 114, the mesh changing wire 114 is used for pulling the connected filtering layer to peel the connected filtering layer from the multiple filtering layers, and the mesh changing wire 114 connected to the filtering net can perform a mesh changing operation according to the thrombus filtering condition in the using process, so that the filtering layer blocked by thrombus is recovered, and then the filtering layer of the next layer is filtered; the filter layers of different layers can be arranged to carry out graded filtration from sparse to dense, so that the phenomenon that small thrombus does not grab the net due to the blockage of large thrombus is reduced.

The following table 1 is a table comparing the effect of the conventional single-layer filter screen and the multi-layer filter screen of the present embodiment on the thrombus:

TABLE 1

The filtering effect of the multilayer filter screen on the thrombus is obviously better than that of the single-layer filter screen on the thrombus by the table 1.

Other structures refer to example four.

The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.

Claims

1. The thrombus filtering device for the operation is characterized by comprising a filtering layer, a filtering layer supporting frame, a fixing support and a control wire; the filter layer support frame is ship-shaped and is used for supporting in a blood vessel; the filter layer is covered on the filter layer bracket and is used for filtering thrombus; the fixing supports comprise a plurality of fixing supports which are respectively fixed on different sides of the filtering layer support frame so as to support the stable support of the vessel wall auxiliary filtering layer support frame; the plurality of fixing supports are respectively connected with a control wire, and the control wires are used for pulling the fixing supports to adjust the positions of the fixing supports.

2. The thrombus filtering device for operation according to claim 1, wherein a wire control bracket is provided on the filter layer support frame, and the wire control bracket is used for threading and winding a wire control wire to change the tension direction of the wire control wire.

3. A surgical thrombus filter device according to claim 2 wherein the abutting ends of the fixed stent and the vessel wall are textured to increase friction.

4. A thrombus filter device for surgery according to claim 3, wherein the filter layer is a multi-layer filter structure.

5. The thrombus filter device according to claim 4, wherein the multiple layers of filter layers comprise filter layers with different filtering precisions, the material comprises one or more of a filter screen and a filter membrane, and the filter layers are loaded with one or more drugs.

6. A thrombus filter device for surgery according to claim 5, wherein a net-changing wire is connected to each of the plurality of filter layers, and the net-changing wire is used to pull the connected filter layer to be peeled off from the plurality of filter layers.

7. The thrombus filtering device for operation according to claim 6, wherein the number of the fixing supports is two, and the fixing supports are splayed in shape and comprise an upper fixing support and a lower fixing support which are respectively fixed at both sides of the middle part of the filter layer supporting frame; the top of the splayed upper fixing support and the top of the splayed lower fixing support are respectively connected with respective control wires, and the bottoms of the splayed upper fixing support and the splayed lower fixing support are respectively connected to two sides of the middle part of the filter layer supporting frame.

8. The thrombus filter device for surgery according to claim 7, wherein the wire control stent is placed at an end of the filter layer stent, the wire control stent is shaped like a figure 8, and the wire control of the upper and lower fixed stents respectively passes through two loops of the figure 8 of the wire control stent and is folded back to the other end of the filter layer stent.

9. The thrombus filter device for surgery according to claim 8, wherein the filter layer support frame is composed of 2-10 elastic memory material wires, and the elastic memory material wires are composed of one or more of nickel titanium wires, stainless steel wires, polyurethane, polylactic acid and its copolymer modification, carbon fibers, glass fibers and Kevlar fibers; the connection mode of the filter layer support frame and the fixing support comprises any one of welding, integral forming and fixing piece connection.

10. The thrombus filter device for surgery of any one of claims 1-9, wherein the wire diameter of the wire control is less than 0.1mm, and the wire control is made of one or more of nitinol wire, stainless steel wire, carbon fiber and glass fiber.