CN112294396A

CN112294396A - Thrombus stirring device

Info

Publication number: CN112294396A
Application number: CN201910698840.2A
Authority: CN
Inventors: 张磊; 冯海全; 李靖; 王永刚
Original assignee: Suzhou Tianhong Shengjie Medical Apparatus And Instruments Co ltd
Current assignee: Suzhou Tianhong Shengjie Medical Apparatus And Instruments Co ltd
Priority date: 2019-07-31
Filing date: 2019-07-31
Publication date: 2021-02-02

Abstract

The invention relates to a thrombus stirring device, which comprises a first sheath tube, a second sheath tube sleeved outside the first sheath tube in a sliding manner, and a stirring assembly arranged at the far end of the first sheath tube; the stirring assembly comprises a plurality of stirrers which are sequentially arranged along the axial direction of the first sheath pipe and have a furled state and an unfolded state, and two adjacent stirrers are connected through an elastic piece so that the two adjacent stirrers can relatively approach or depart from each other along the axial direction of the first sheath pipe; when the stirrer is in a folded state, the stirring assembly is positioned in the second sheath, so that the thrombus stirring device is conveniently implanted into and recovered from a blood vessel; when the stirrer is in an unfolded state, the stirring assembly is separated from the second sheath pipe. The invention has simple structure, low preparation cost and convenient operation, can well remove old thrombus and has small damage to blood vessels.

Description

Thrombus stirring device

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a thrombus stirring device.

Background

The existing treatment methods mainly comprise vascular incision embolectomy, catheter contact thrombolysis and percutaneous mechanical aspiration embolectomy, wherein the incision embolectomy needs to be performed through dissection separation and blood vessel incision, such as femoral artery, femoral vein or brachial artery incision, and with the development of intracavity intervention technology and the innovation of materials, the open operation mode is gradually replaced by minimally invasive intracavity treatment, namely catheter contact thrombolysis and percutaneous mechanical aspiration embolectomy. Catheter contact thrombolysis is not beneficial to many patients because of the high risk of thrombolysis drug bleeding and the extreme severity of the surgical indications, and a large proportion of patients have catheter contact thrombolysis contraindications.

Based on the existing medical cognition, the deep venous thrombosis is often large in capacity, and the acute-phase thrombosis is soft and fragile in texture; arterial thrombosis often has small volume, and thrombus in an acute stage is soft in texture; old thrombi tend to adhere to the vessel wall. For old thrombus, the existing thrombus removing device mainly uses a spiral cutter at the front end of a catheter to cut thrombus and a thrombus removal catheter system for extracting blood clots out of a body by suction, such as an X-sizer thrombus removal catheter system, and chinese patent CN204092102U discloses a novel peripheral vascular disease thrombus suction connector, which comprises: the rotary tail seat comprises a pipe body, a rotary rod, a spiral rotary piece, an arc joint and a connecting tail seat, wherein the pipe body is in a hollow tubular shape, the upper end of the pipe body is movably connected with the arc joint through threads, a rectangular groove is formed in the middle upper portion of the pipe body, the rotary rod is inserted into the pipe body, and the spiral rotary piece is sleeved on the periphery of the rotary rod. However, the thrombus removal device has a complicated structure, high production cost, and cumbersome use, and when the thrombus on the vascular wall is detached by the rotation of the spiral cutter or the spiral rotary piece in the blood vessel, the vascular endothelium is easily damaged.

Disclosure of Invention

The invention aims to provide a thrombus stirring device with different structures.

In order to solve the technical problems, the invention adopts the following technical scheme:

a thrombus stirring device comprises a first sheath tube, a second sheath tube which is sleeved outside the first sheath tube in a sliding manner, and a stirring assembly arranged at the far end of the first sheath tube; the stirring assembly comprises a plurality of stirrers which are sequentially arranged along the axial direction of the first sheath pipe and have a furled state and an unfolded state, and two adjacent stirrers are connected through an elastic piece so that the two adjacent stirrers can relatively approach or depart from each other along the axial direction of the first sheath pipe; when the stirrer is in a folded state, the stirring assembly is positioned in the second sheath, so that the thrombus stirring device is conveniently implanted into and recovered from a blood vessel; when the stirrer is in an unfolded state, the stirring assembly is separated from the second sheath pipe. During the operation, through to near-end withdrawal second sheath pipe, a plurality of agitators break away from and expand automatically from the second sheath pipe, and medical personnel make stirring subassembly round trip movement in the blood vessel through making a round trip to pull first sheath pipe, and a plurality of agitators make a round trip to scrape the vascular wall and stir the thrombus in the blood vessel to realize that the thrombus drops from the vascular wall, the breakage of thrombus and the seizure of thrombus. The proximal end is defined by the side close to the medical staff when the thrombus stirring device is used; the far end is defined by the side far away from the medical staff when the thrombus stirring device is used.

According to the invention, two adjacent stirrers are elastically connected by the elastic piece, so that certain buffering effect is achieved among the stirrers and between the stirrers and the blood vessel when the first sheath is dragged back and forth.

The number of the stirrers can be set as required, and preferably 2-3 stirrers are used.

The elastic part can be a thin-wall tube, according to one embodiment, the elastic part is a spring, the spring comprises all parts which are spiral and have elasticity like the spring, the processing is convenient in process, the elastic part can pass through a complex lesion blood vessel in the using process, and the flexibility of the diameters of the sheath tube and the stirrer can be improved.

Wherein, elastic component and first sheath pipe can be welding or integrative setting, preferably, elastic component with first sheath pipe integrative setting, through carrying out the elastic component that spiral cutting formed similar spring on one section of first sheath pipe promptly to make preparation convenient and the fastness good.

Preferably, when the elastic part is in a static state, the distance between every two adjacent stirrers is 5-10 mm, so that the stirrers can be improved to have good flexibility in the dragging process.

Preferably, the stirrer is a mesh basket made of memory wires, and can be formed by laser cutting and then heat setting a whole tube made of nickel-titanium alloy. The setting of basket makes when making a round trip to pull the agitator, and the area of contact of agitator and vascular wall is little to it is little to the damage of vascular wall, and the agitator can carry out partial breakage and interception to the thrombus in the blood vessel and catch.

Further preferably, the projection of the stirrer on the plane perpendicular to the axis of the first sheath tube is in a petal shape, the number of petals can be set according to actual needs, and is preferably set to 4-6 petals, so that the effective blocking section can be ensured.

Further preferably, projections of the plurality of stirrers on a plane perpendicular to the axis of the first sheath are offset from each other, so that an effective intercepting area for intercepting thrombus is increased.

The "plane perpendicular to the axis of said first sheath" defined herein is an axis defined by the first sheath shown in fig. 1 extending in a straight line, and the plane is perpendicular to the straight line axis.

Preferably, the stirrer is spherical, the spherical stirrer is not easy to scratch the vessel wall, the wall adhesion performance is good, and old wall adhesion thrombus is easy to remove.

Further preferably, the diameter of the stirrer is 9-14 mm, so that the stirrer can adapt to blood vessels with different inner diameters.

The memory wire herein may be a memory alloy such as nitinol.

Preferably, the first sheath pipe penetrates through the plurality of stirrers, and the axis of the first sheath pipe coincides with the center line of the plurality of stirrers, so that the thrombus stirring device is convenient to prepare, simple to operate and small in damage to a blood vessel wall.

Due to the implementation of the technical scheme, compared with the prior art, the invention has the following advantages:

the invention has simple structure, low preparation cost and convenient operation, can well remove old thrombus and has small damage to blood vessels.

Drawings

FIG. 1 is a schematic diagram of a thrombus removal system according to an embodiment;

FIG. 2 is a cross-sectional view taken along line A-A of FIG. 1;

FIG. 3 is a cross-sectional view taken along line B-B of FIG. 1;

FIG. 4 is a cross-sectional view taken along line C-C of FIG. 1;

FIG. 5 is a schematic view showing the superposition of the sectional view B-B and the sectional view C-C;

FIG. 6 is an enlarged view of a portion of FIG. 1 at position D;

FIG. 7 is an enlarged view of a portion of FIG. 1 at location E;

fig. 8 is a schematic structural view of the stirring device according to the first embodiment before deployment (the second sheath is retracted, but before the stirrer is opened);

fig. 9 is a schematic structural view of the stirring apparatus according to the first embodiment after development;

fig. 10 is a schematic structural view of the stirring device of the second embodiment after being unfolded;

fig. 11 is a schematic structural view of a stirring apparatus according to a second embodiment of the present invention before being expanded;

wherein, 1, a suction catheter; 2. a guide wire; 11. a suction channel; 12. a guidewire channel; 13. filling the channel; 14. a bevel; 15. filling the interface; 16. a suction interface; 17. other device interfaces; 18. a balloon; 31. plugging the catheter; 32. an occluder; 41. a first sheath tube; 42. a second sheath; 43. a stirrer; 44. a memory wire; 45. an elastic member.

Detailed Description

The present invention will be described in further detail with reference to specific examples. It is to be understood that these embodiments are provided to illustrate the basic principles, essential features and advantages of the present invention, and the present invention is not limited by the following embodiments.

As shown in FIG. 1, the thrombectomy system of the present invention comprises an aspiration catheter 1, a guide wire 2, an agitation device, and an occlusion device.

The suction catheter 1 has a suction channel 11 for sucking thrombus, a guide wire channel 12 for passing the guide wire 2, and an inflation channel 13. The suction channel 11 extends along the axial direction of the suction catheter 1 and penetrates both ends of the suction catheter 1, the guide wire channel 12 is located at the distal end of the suction catheter 1, and the filling channel 13 extends along the axial direction of the suction catheter 1.

The filling channel 13, the suction channel 11 and the guide wire channel 12 are respectively separated from each other and do not communicate, and the filling channel 13 and the guide wire channel 12 are respectively positioned at two sides of the suction channel 11, as shown in fig. 2.

The distal end face of the suction catheter 1 is a slope 14, as shown in fig. 7, the outlets of the distal ends of the suction channel 11 and the guide wire channel 12 are both opened on the slope 14, and the outlet of the guide wire channel 12 is located at the distal end of the slope 14, namely the tip position of the suction catheter 1.

As shown in fig. 1, the proximal end of the aspiration catheter 1 is provided with a filling port 15 communicated with the filling channel 13, an aspiration port 16 communicated with the aspiration channel 11, and an other device port 17 communicated with the aspiration channel 11, that is, the outlet of the proximal end of the filling channel 13 is communicated with the filling port 15, and the outlet of the proximal end of the aspiration channel 11 is communicated with the aspiration port 16 and the other device port 17, respectively. Preferably, the axis of the further device interface 17 coincides with the axis of the suction channel 11, so that the further device is accessible.

The distal end of the suction catheter 1 is fixedly provided with a balloon 18, and the balloon 18 is communicated with the distal outlet of the filling channel 13, so that the balloon 18 can be filled and released through the filling interface 15 and the filling channel 13, and the balloon 18 has an open state and a folded state. When the suction catheter 1 is implanted and recovered, the balloon 18 is in a folded state, so that the implantation and the recovery of the suction catheter 1 are facilitated; when in use, the balloon 18 is in an open state, the outer diameter of the balloon 18 is larger than or equal to the inner diameter of a blood vessel, and the outer diameter of the balloon 18 is preferably equal to or slightly larger than the inner diameter of the blood vessel, so that the blood vessel can be blocked, the blood flow can be temporarily blocked, and the loose free thrombus in the thrombus removal process can be prevented from drifting to other blood vessels.

In this embodiment, the balloon 18 is located between two outlets of the guide wire channel 12, as shown in fig. 1, i.e. the outlet of the proximal end of the guide wire channel 12 opens onto the wall of the suction catheter 1, which outlet is located at the front end of the balloon 18.

In this embodiment, the aspiration catheter 1 is a catheter with three lumens, although other catheters with multiple lumens may be used instead. The guidewire channel 12 of the aspiration catheter 1 may be passed over an OTW rapid exchange guidewire or a central push guidewire, fitting, but not limited to, a 0.014 "guidewire. The suction catheter 1 reserves other equipment passages while ensuring the capability of sucking thrombus, thereby being capable of dealing with various complicated thrombus.

As shown in fig. 1, the occlusion device comprises an occlusion catheter 31, an occluding device 32 arranged at the distal end of the occlusion catheter 31 and having an open state and a collapsed state, wherein the occluding device 32 is a balloon which can be inflated by inflating or filling a liquid.

When the occluder 32 is in an open state, the outer diameter of the occluder 32 is larger than or equal to the inner diameter of the blood vessel, preferably, the outer diameter of the occluder 32 is equal to or slightly larger than the inner diameter of the blood vessel, so that the occluder 32 is attached to the inner wall of the blood vessel, and when the occluder 32 is used, the occluder 32 is positioned at the far end of the suction catheter 1 and acts with the balloon 18 of the suction catheter 1 simultaneously, so that a closed space is formed in the blood vessel in a short time, and therefore, the stirring device can achieve good curative effect when dragging thrombus or thrombolysis. When the occluder 32 is in a collapsed state, the occluding device can pass through the suction channel 11.

The stirring device comprises a first sheath tube 41, a second sheath tube 42 which is sleeved outside the first sheath tube 41 in a sliding manner, and a stirring component which is arranged at the far end of the first sheath tube 41; the agitator assembly includes an agitator 43 having an expanded state and a collapsed state, the agitator 43 having an outer diameter in the expanded state that is less than or equal to the inner diameter of the blood vessel. In use, the stirring assembly and the first sheath 41 are folded in the second sheath 42, the stirring device enters the suction channel 11 from the interface of other equipment and enables the stirrer 43 to be positioned between the suction catheter 1 and the occluder 32, the second sheath 42 is retracted, the stirrer 43 is opened, and the stirrer 43 moves back and forth in the blood vessel by dragging the first sheath 41 back and forth.

The first implementation mode comprises the following steps:

as shown in fig. 8 and 9, only one stirrer 43 is formed by shaping several braided memory filaments 44, and can be retracted proximally through the second sheath tube 42 to achieve self-expansion, and when the first sheath tube 41 is dragged, the degree of adherence and the dragging force of the memory filaments 44 can be controlled by adjusting the opening degree of the stirrer 43 through the length of the retracted second sheath tube 42.

The first sheath 41 is inserted through the stirrer 43 and the axis of the first sheath 41 is aligned with the center line of the stirrer 43, and the stirrer 43 is fixed to the first sheath 41 by welding or other processes.

The shape of the baskets may be that commonly used in the art, such as spherical, fusiform, etc. The memory wire 44 may be made of a memory alloy such as nitinol.

The second embodiment:

the number of stirrers 43 is plural, and as shown in fig. 10 and 11, two stirrers 43 are provided, which are provided in this order along the axial direction of the first sheath 41. Adjacent two stirrers 43 are connected by an elastic member 45 so that adjacent two stirrers 43 can relatively move closer to or away from each other in the axial direction of first sheath 41.

As shown in fig. 6, the elastic member 45 is provided integrally with the first sheath 41, and the elastic member 45 like a spring is formed by spirally cutting a section of the first sheath 41.

When the elastic member 45 is in a static state (i.e. the elastic member 45 is not extended and is not compressed), the distance between two adjacent stirrers 43 is 5-10 mm.

Stirrer 43 is a basket made of memory wire 44, for example, made of nitinol through a tube that is laser cut and then heat set. The stirrer 43 is spherical, and the diameter of the stirrer 43 is 9-14 mm.

As shown in fig. 3 and 4, the stirrer 43 has a petal-shaped projection on a plane perpendicular to the axis of the first sheath 41, and the number of petals can be set according to actual needs, preferably 4 to 6 petals, and in this embodiment, 5 petals.

As shown in fig. 5, projections of the plurality of stirrers 43 on a plane perpendicular to the axis of first sheath 41 are offset, that is, projections of memory wires 44 of the plurality of stirrers 43 on the plane are offset.

The first sheath 41 is inserted through the stirrer 43, and the axis of the first sheath 41 and the center line of the stirrer 43 are overlapped with each other, and the stirrer 43 is fixed to the first sheath 41 by welding or other processes.

The thrombus removal system also comprises a guide wire 2 and a thrombolytic tube, and the improvement of the guide wire 2 and the thrombolytic tube is not the key point of the protection of the invention, and the guide wire 2 and the thrombolytic tube in the prior art can be adopted.

Suction catheter 1, plugging device, agitating unit are independent packing respectively, when selling, can be equipped with the seal wire 2 and the thrombolysis pipe of independent packing, make things convenient for the whole set of use of medical personnel.

The thrombus removal system comprises the following use steps:

1. the guide wire 2 is threaded to the lesion.

2. The guide wire 2 is passed through the guide wire channel 12 so as to send the suction catheter 1 to the front end of the lesion part, and the blockage situation is observed by radiography.

3. The occluding device is accessed from the other device port, delivered through the aspiration channel 11 and passed through the lesion, the distal end of the blood vessel is occluded by inflating the occluding device 32 through the occluding catheter 31, and the proximal end of the blood vessel is occluded by inflating the balloon 18 through the inflation port 15 and the inflation channel 13, so that a short period of time of occlusion is formed between the occluding device 32 and the balloon 18.

4. The thrombolysis tube enters from other equipment interfaces and is conveyed to a lesion part in the closed space through the suction channel 11, thrombolysis is carried out on the thrombolysis tube in the characteristic space, and the thrombolysis tube is taken out after thrombolysis is finished.

5. The stirring device enters from other equipment interfaces, is conveyed to the lesion part in the closed space through the suction channel 11, and the second sheath tube 42 is withdrawn to open the stirrer 43.

6. The first sheath 41 is grasped and repeatedly pulled, and simultaneously, negative pressure is sucked through the suction port 16 via the suction channel 11.

7. After the insoluble thrombus is attached to the stirrer 43, the first sheath 41 is withdrawn, and the thrombus is extracted from the body.

8. After the stirrer 43 is completely removed, the aspiration catheter 1 is repeatedly aspirated to thereby extract the remaining thrombus.

9. After the thrombus is taken out, the occluder 32 and the saccule 18 are decompressed, the contrast observation is carried out again to observe the treatment effect, and if the thrombus is not completely taken out, the steps are repeated until the thrombus is completely sucked.

10. After the treatment is completed, the suction catheter 1 is withdrawn along the guide wire 2, and then the occluder 32 is withdrawn.

The steps are the processing steps for old thrombus which is difficult to process, and for some thrombus which is easier to process, the steps of thrombolysis, thrombolysis and the like can be correspondingly omitted.

The invention intervenes through the guide wire 2, and the blood vessel is blocked when the balloon 18 and the stopper 32 of the suction catheter 1 are full, thereby facilitating the operation of a doctor, simultaneously increasing the effect of placing the catheter for thrombolysis and preventing the thrombus from falling off and floating to the heart in the thrombus taking process. The use of a large scale aspiration catheter 1 in combination with the agitator 43 in the vein effectively removes large areas of acute and subacute thrombus in the inferior vena cava. Can dissolve the thrombus earlier when reply old thrombus of inferior vena cava, then draw to suction catheter 1 in through agitator 43, use this apparatus can remove a large amount of thrombus in the inferior vena cava under the circumstances of guaranteeing relative safety, protection venous valve and venous blood vessel wall, the amount of blood loss is controllable, and operating procedure is simple, shortens operating time, alleviates patient's cost of being in hospital.

As described above, the present invention has been explained fully in accordance with the gist of the present invention, but the present invention is not limited to the above-described examples and implementation methods. A practitioner of the related art can make various changes and implementations within a range allowed by the technical idea of the present invention.

Claims

1. A thrombus stirring device is characterized in that: the stirring device comprises a first sheath tube (41), a second sheath tube (42) which is sleeved outside the first sheath tube (41) in a sliding manner, and a stirring component which is arranged at the far end of the first sheath tube (41); the stirring assembly comprises a plurality of stirrers (43) which are sequentially arranged along the axial direction of the first sheath pipe (41) and have a folded state and an unfolded state, and two adjacent stirrers (43) are connected through an elastic piece (45) so that the two adjacent stirrers (43) can relatively approach or depart from each other along the axial direction of the first sheath pipe (41); when the stirrer (43) is in a furled state, the stirring assembly is positioned in the second sheath tube (42); when the stirrer (43) is in an unfolded state, the stirring assembly is separated from the second sheath tube (42).

2. The thrombus stirring device according to claim 1, wherein: the elastic piece (45) is a spring.

3. The thrombus stirring device according to claim 1, wherein: the elastic piece (45) and the first sheath tube (41) are integrally arranged.

4. The thrombus stirring device according to claim 1, wherein: when the elastic piece (45) is in a static state, the distance between two adjacent stirrers (43) is 5-10 mm.

5. The thrombus stirring device according to claim 1, wherein: the stirrer (43) is a mesh basket made of memory wires (44).

6. The thrombus stirring device according to claim 5, wherein: the projection of the stirrer (43) on a plane perpendicular to the axis of the first sheath (41) is in a petal shape.

7. The thrombus stirring device according to claim 5, wherein: the projections of the stirrers (43) on a plane perpendicular to the axis of the first sheath (41) are offset from each other.

8. The thrombus stirring device according to claim 1 or 5, wherein: the stirrer (43) is spherical.

9. The thrombus stirring device of claim 9, wherein: the diameter of the stirrer (43) is 9-14 mm.

10. The thrombus stirring device according to claim 1, wherein: the first sheath pipe (41) penetrates through the stirrers (43), and the axis of the first sheath pipe (41) and the center lines of the stirrers (43) are overlapped.