CN113413192A

CN113413192A - Diameter and length adjustable bolt taking device

Info

Publication number: CN113413192A
Application number: CN202110845847.XA
Authority: CN
Inventors: 顾兴中; 李书翔; 张玉成
Original assignee: Taizhou Institute Of Biomedicine And Medical Devices Southeast University
Current assignee: Taizhou Institute Of Biomedicine And Medical Devices Southeast University
Priority date: 2021-07-26
Filing date: 2021-07-26
Publication date: 2021-09-21
Anticipated expiration: 2041-07-26
Also published as: CN113413192B

Abstract

The invention discloses a thrombus removal device with adjustable diameter and length, which comprises a controller, a delivery guide wire and a plurality of cage support units, wherein the controller is provided with a gripping part and an adjusting button arranged in the gripping part; at least one ball cage unit is connected outside the conveying guide wire; the two ends of each cage support unit are respectively provided with a near-end central conveying guide hole and a far-end central conveying guide hole for the penetration and the fixed connection of a conveying guide wire, and a plurality of near-end traction through holes and a plurality of far-end traction through holes which are respectively arranged along the outer sides of the near-end central conveying guide hole and the far-end central conveying guide hole are connected with the traction guide wire for use; the traction guide wire is connected with and controls the cage support unit to change length and diameter. The diameter of the embolectomy device can be manually adjusted so as to accurately control the diameter of the embolectomy device, the diameters of all cage support units are changed consistently, and 1 embolectomy device can meet the requirements of blood vessels with various diameters, so that the purchase cost of an operation and the cost of the operation are reduced.

Description

Diameter and length adjustable bolt taking device

Technical Field

The invention relates to the technical field of thrombus taking devices, in particular to a thrombus taking device which can remove thrombus in intracranial large blood vessels of patients with ischemic stroke and can independently control cage bracket units.

Background

Stroke has a high morbidity, mortality, disability rate, and serious harm to the health and quality of life of the public. Among them, Acute Ischemic Stroke (AIS), which accounts for about 70% of all strokes, is one of the most common types. AIS is usually treated by intravenous thrombolysis, and the commonly used drug is rtPA (alteplase). However, the drug thrombolysis is only suitable for thrombus with smaller volume, the treatment effect on thrombus embolism with large volume is not ideal, and about only 3-5% of patients are suitable for drug thrombolysis treatment.

For the treatment of AIS for large vessel occlusion, the most suitable method is mechanical embolectomy. Mechanical embolisms on the market go through 3 generations, and the first generation of mechanical embolisms is a spiral embolectomy device represented by Merci and consists of coils made of nickel-titanium alloy, so that massive thrombi can be removed, but the death rate is high. The second generation of mechanical embolectomy is the Penumbra aspiration system, which consists of a septal reperfusion catheter for occlusion from the ICA to the M2 Middle Cerebral Artery (MCA). Penumbra, despite its high recanalization rate, still has poor clinical results (only 25%) with a complication rate as high as 12.8%. The third generation mechanical thrombus taking device is a thrombus taking device system, the system consists of a thrombus taking net with a bracket, a pushing metal wire and a radiopaque marker (a near-end developing ring and a far-end developing point), when the thrombus taking device is used, the thrombus taking device enters a blood vessel along with a microcatheter, and after the thrombus enters a preset position of the blood vessel, thrombus blocking the blood vessel is taken out from a reticular lumen formed by self-expansion, and the thrombus taking device has the advantages of high thrombus taking success rate and low death rate.

However, the embolectomy device still faces a number of problems: the registered thrombus taking devices on the market in the domestic market, such as Reco stents of Nicots and Captor stents of Shanghai Renwei medical treatment company, are far-end open stents, the ends of the far-end open stents are usually welded with developing metal, and the structures are favorable for reducing the non-working length of the far ends of the stents and reducing the friction force. But the structure with the open distal end is not easy to collect smaller thrombus and is easy to cause thrombus to fall off in the stent withdrawing process; the contact surface of the far-end open structure stent and the vessel wall is still large, and the injury to the vessel wall is large when the stent passes through a tortuous complex vessel; open stents still have a certain non-working length and cannot accurately position the proximal end of the effective working length of the stent.

Although the chinese patent CN 209678625U-a new thrombus taking-out stent and thrombus taking-out device, a new thrombus taking-out stent and a thrombus taking-out device with the same are disclosed, comprising a stent body which is self-expanding along the circumferential direction of its longitudinal axis, the stent body is composed of a plurality of spherical stent units, and a developing material of an opaque ray material runs through the whole stent from the distal end of the stent to the proximal end of the stent, including both ends of the stent, between the spherical stent units and on the stent rods; the stent rod of the spherical unit has higher radial supporting force and forms a three-dimensional structure with the spherical unit node of the stent, the stent rod can be quickly embedded into thrombus and anchor the blood vessel, the thrombus taking stent can be in more three-dimensional contact with the thrombus, the stability of thrombus capture can be increased, the possibility of thrombus slippage is reduced, and the thrombus taking effect is better; the developing structures on the two spherical unit nodes and the support rod can make the shapes of the thrombus taking support and the thrombus more clear in the thrombus taking process, accurately identify the effective length of the thrombus taking support, judge whether the thrombus taking support is completely released and expanded, and judge the contact condition of the thrombus taking support and the thrombus, so that the operation and the judgment of a doctor are facilitated; the thrombus removal support is connected by a plurality of spherical unit bodies, so that the invalid working length of the support can be reduced, the operation and judgment of doctors are facilitated, and the success rate of thrombus removal of the support is improved.

However, in the using process, the diameter change of the spherical support unit cannot be accurately controlled, the expected operation effect is difficult to achieve, the injury to blood vessels is relatively large, the operation process is relatively complex, inconvenience is brought to doctors, and the pain of patients is increased.

Therefore, the technical problem to be solved by the patent is as follows: how to accurately and efficiently control the embolectomy device and how to better display the embolectomy process of the embolectomy device so as to reduce the trauma of the patient as much as possible, achieve the expected operation effect and facilitate the operation of doctors.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides the thrombus taking device which can realize diameter change of a cage bracket unit by converging the conveying guide wire and the traction guide wire in the controller and simultaneously controlling the traction guide wire and the conveying guide wire by virtue of the regulating button, when the whole thrombus taking device enters a human body and is released, the regulating button is pulled out, the traction wire is regulated to be in a proper size, and thrombus is taken after the traction wire is pressed down and locked, so that the diameter of the bracket in the neurovascular can be accurately controlled.

The technical scheme adopted by the invention is as follows: the utility model provides a diameter and length can be regulated and control get and tie device, includes controller, transport seal wire and a plurality of cage support unit, sets for near-end near controller one end, keeps away from controller one end and is the distal end, wherein:

the controller is provided with a gripping part and a regulating button arranged in the gripping part;

the external part of the conveying guide wire is connected with at least one ball cage unit, one end of the conveying guide wire is fixedly connected with a regulating button, and the other end of the conveying guide wire is connected with a soft guide head;

each cage support unit is provided with a near-end central conveying guide hole and a far-end central conveying guide hole at two ends respectively for the conveying guide wire to penetrate and be fixedly connected, and a plurality of near-end traction through holes and a plurality of far-end traction through holes are arranged along the outer sides of the near-end central conveying guide hole and the far-end central conveying guide hole respectively so as to be connected with the traction guide wire for use;

and the near end of the traction guide wire is fixedly connected with the control button, the farthest end of the traction guide wire is fixedly connected with the traction through holes of the cage support units corresponding to the traction guide wire, and the traction through holes penetrate through a plurality of near end traction through holes and a plurality of far end traction through holes of all the cage support units between the corresponding cage support units and the controller in a clearance-keeping manner.

And the delivery guide wire is fixedly connected with the proximal end central delivery guide hole of each cage support unit and passes through the distal end central delivery guide hole with a gap.

Preferably, each cage support unit is respectively provided with a developing mark near the proximal end of the delivery guide wire and near the outer side of the distal end of the traction guide wire.

Preferably, the number of the traction guide wires of each cage support unit is 2-6.

Preferably, each cage support unit is fixedly connected with the delivery guide wire or the traction guide wire, and the cage support unit comprises, but is not limited to, laser welding and high polymer material fusion welding.

Preferably, the grip part of the controller is also provided with a scale size which is matched with the regulating button to accurately regulate the stroke of the conveying guide wire and the traction guide wire.

Preferably, the soft guiding head is of a J-shaped structure, and the soft degree needs to be satisfied, so that the spherical support unit can slide on the delivery guide wire.

Preferably, the free end of the soft guiding head of the tip of the delivery guide wire protrudes out of the most distal end of the cage scaffold unit.

Preferably, each cage support unit is made of a plurality of ribs which are bent and crossed, and the two ends of each cage support unit are gathered to form an overall ellipsoid-like and spherical structure, and the outer surface of each cage support unit is covered with a macromolecular hydrophilic coating.

Preferably, each cage support unit comprises, in sequence from the proximal end to the distal end, a support portion, a curved portion and a traction hook portion, and the curved portion has a diameter greater than the diameter of the support portion and the diameter of the traction hook portion, and the curved portion has a length in the direction of delivery of the delivery guidewire greater than the length of the support portion and greater than the length of the traction hook portion.

Compared with the prior art, the invention has the beneficial effects that:

1. the length of the ineffective segment is small, thereby being convenient for the clinical operation of doctors.

2. The diameter of the embolectomy device can be manually adjusted, the diameter of the embolectomy device can be accurately controlled, the diameter change of each cage support unit is consistent, and the requirement that 1 embolectomy device meets blood vessels with various diameters can be met, so that the purchase cost of an operation and the cost of the operation are reduced.

3. The distal end is the closed structure of cage support unit, can collect more microthrombosis, prevents that the thrombus of withdrawal in-process from escaping.

4. The cage structure of the cage support unit reduces the contact area of the support and the blood vessel and reduces the injury.

5. The structure of the development mark is in the thrombus taking device, can not be in direct contact with the blood vessel wall, and can judge the stretching condition of the stent through development, so that the operation is more visual and controllable.

6. A plurality of cage support units are connected in series through conveying guide wires, and controllability, flexibility and adherence performance are better.

Drawings

FIG. 1 is a general block diagram of the embolectomy device of the present invention;

FIG. 2 is a schematic view of the connecting structure of the delivery guide wire and the traction guide wire and cage support unit of the embolectomy device of the present invention;

FIG. 3 is a schematic structural view of a cage support unit of the embolectomy device provided in the practice of the present invention;

FIG. 4 is a schematic structural view of two cage support units of the present invention when connected;

FIG. 5 is a schematic diagram illustrating the trend of the thrombus removal device before diameter adjustment;

FIG. 6 is a schematic diagram illustrating the variation of the diameter of the embolectomy device provided by the practice of the present invention after adjustment;

FIG. 7 is a schematic view of an embolectomy device provided in the practice of the present invention as it is retracted in use with a microcatheter;

wherein: 10-controller, 11-grip, 12-control button, 13-scale size;

20-delivery of guide wire;

30-cage support unit, 31-proximal end central conveying guide hole, 32-distal end central conveying guide hole, 33-proximal end drawing through hole, 34-distal end drawing through hole and 35-rib;

40-traction guide wire, 50-visualization mark, 60-visualization mark, 70-soft guide head, 80-microcatheter and 90-thrombus.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention.

In the description of the present invention, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the combination or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, are not to be construed as limiting the present invention. In addition, in the description process of the embodiment of the present invention, the positional relationships of the devices such as "upper", "lower", "front", "rear", "left", "right", and the like in all the drawings are based on fig. 1.

As shown in FIG. 1, a embolectomy device with adjustable diameter and length comprises a controller 10, a delivery guide wire 20 and a plurality of cage support units 30, wherein one end close to the controller 10 is set as a proximal end, and the other end far away from the controller 10 is set as a distal end, wherein:

a controller 10 having a grip 11 and a manipulation button 12 disposed in the grip 11;

the external part of the conveying guide wire 20 is connected with at least one ball cage unit 30, one end of the conveying guide wire is fixedly connected with the regulating button 12, and the other end of the conveying guide wire is connected with the soft guide head 70;

as shown in detail in fig. 2, 3 and 4, each cage support unit 30 is provided with a proximal central transport guide hole 31 and a distal central transport guide hole 32 at two ends thereof, and a feeding transport guide wire 20 is fixedly connected in a penetrating manner, and a plurality of proximal traction through holes 33 and a plurality of distal traction through holes 34 are respectively arranged along the outer sides of the proximal central transport guide hole 31 and the distal central transport guide hole 32 so as to be connected with a traction guide wire 40;

a traction guide wire 40, the proximal end of which is fixedly connected with the control button 12, the most distal end of which is fixedly connected with the traction through hole 31 of the cage support unit 30 corresponding thereto, and which penetrates through a plurality of proximal traction through holes 33 and a plurality of distal traction through holes 34 of all cage support units 30 between the corresponding cage support unit 30 and the controller with a gap;

the conveying guide wire and the traction guide wire are finally gathered in the controller, wherein the regulating button is only used for simultaneously controlling the traction wire to move for the same distance, the diameter changing of the support is realized, after the support enters a human body and is released, the regulating button is pulled out, the traction wire is regulated to be in a proper size and then is pressed down to be locked, the thrombus taking is started, and the diameter of the support in the neurovascular can be accurately controlled. The variation of the cage support unit can be seen with reference to the structure of figure 1, and the trend of the embolectomy device of figures 5 and 6 before and after adjustment of the diameter.

Referring to fig. 2 and 4, in another embodiment different from the previous embodiment, the delivery guide wire 20 is fixedly connected to the proximal central delivery guide hole 31 of each cage support unit 30 and passes through the distal central delivery guide hole 32 with a gap, so as to improve the uniformity of diameter and length adjustment of each cage support unit and ensure that the delivery guide wire 20 can slide in the distal central delivery guide hole 32.

As shown in fig. 4, a more preferred embodiment is that each cage support unit 30 is provided with a

visualization mark

50 and 60 respectively near the proximal end of the delivery guide wire 20 and near the outer side of the distal end of the traction guide wire 40, the visualization structure is a cylinder made of medical heavy metal such as platinum, gold, platinum alloy, tantalum, etc., and the visualization structure is fixed by physical winding, physical extrusion, etc. These development marks are located inside the stent, can not contact with the vascular wall and can judge the flexible condition of stent through the development for realize carrying out inside full range inside development at little pipe, avoided development mark to set up outside and vascular wall contact and cause unnecessary damage to the human body, improved operation cure efficiency. In addition, in the actual implementation process, the positions of the two ends of the conveying guide wire 20 and the traction guide wire 40 are respectively provided with the developing marks, so that the transparency of the embolectomy device is further improved, the embolectomy process is more transparent and simplified, and the operation healing efficiency is further improved.

Fig. 3 shows that the better embodiment is that the number of the traction guide wires 40 of each cage support unit 30 is 2-6, namely the number of the proximal traction through holes 33 and the distal traction through holes 34 of each cage support unit 30 is 2-6, and the control effect is better when the traction guide wires 40 are used for traction of 2-6.

The preferred embodiment is that each cage support unit 30 is fixedly connected to the delivery guidewire 20 or the pull guidewire 40, including but not limited to laser welding and fusion welding of polymeric materials, to achieve better fixation and ensure better working conditions.

As can be seen from FIG. 1, a more preferred embodiment is that the controller 10 is further provided with a handle 13 and a scale 14 arranged on the handle, and the scale 14 cooperates with the control button 12 to precisely adjust the stroke of the guide wire 20 and the guide wire 30, so as to change the diameter of the embolectomy device to meet different requirements on the diameter of the embolectomy device. The better embodiment is that the soft guiding head 70 is of a J-shaped structure, which can not only enable the spherical stent unit to slide on the delivery guide wire, but also can not hurt the blood vessel, and has higher safety.

The preferred embodiment is that the free end of the length of the soft guiding head 70 at the end of the delivery guide wire protrudes beyond the farthest end of the cage support unit to allow the farthest end of the cage support unit to have sufficient support, and the outer side of the soft guiding head 70 is generally provided with developing marks, which can also prevent the farthest end of the cage support unit from exceeding the developing ring of the soft guiding head, causing medical accidents.

In a preferred embodiment, each cage support unit 30 is made of a plurality of ribs 35 bent and crossed and gathered at both ends to form an overall ellipsoid-like and spherical structure, and the outer surface of each cage support unit 30 is covered with a polymeric hydrophilic coating, so that the cage support units 30 can move with low resistance or even without resistance during use, and the safety performance of the embolectomy device is improved.

Each cage support unit 30 of the preferred embolectomy device comprises, in order from the proximal end to the distal end, a support section 351, a curved section 352 and a traction hook section 353, the curved section 352 having a diameter larger than the diameter of the support section 351 and the diameter of the traction hook section 353, and the curved section 352 having a length in the delivery direction of the delivery guidewire 20 larger than the length of the support section 351 and larger than the length of the traction hook section 353. According to the embolectomy device composed of the cage support unit 30 with the structural design, the strength design of the supporting part and the traction hook part is relatively high, the bending part 352 is large in diameter and long in length, bending is facilitated, deformation is easy to achieve, and adaptability of the embolectomy device is improved.

The operation steps of applying the thrombus removal device with adjustable diameter and length to clinic are as follows:

first, the thrombus occlusion site is clarified, and if the thrombus is proximal, aortic arch angiography/target vessel proximal angiography is used. If the thrombus is at the far end, performing microcatheter radiography after the thrombus; in the process of microcatheter radiography, the head end of the thrombus taking device exceeds the thrombus far end so as to ensure that the effective length of the thrombus taking device can cover the two ends of the thrombus after the thrombus taking device is completely released, and the position where the microcatheter head end is developed is the planned arrival position of the thrombus taking device far end.

The delivery wire of the embolectomy device then feeds the cage rack units placed thereon to the protective sheath, which feeds the cage rack units to the microcatheter 80, as can be seen in fig. 7. The diameter of the cage stent unit can be controlled by the control button 12 of the grasping part 11 of the controller 10, the thrombus stent sleeved outside the cage stent unit is ensured to be low in release resistance, the thrombus taking device is continuously pushed until the radioactive development mark at the far end exceeds the thrombus (the delivery guide wire is not pushed out) and is superposed with the development ring of the microcatheter 80, and the thrombus is ensured to be positioned at the middle and rear sections of the effective length of the thrombus stent as far as possible.

When the embolectomy device is released in conjunction with the grip portion 11 of the controller 10, the microcatheter 80 is retracted in the proximal direction. The gripping part 11 is matched as slowly as possible, so that the tension is prevented from releasing instantaneously to cut thrombus and cause distal embolism. Ensuring complete release of the thrombus scaffold: the tip of the microcatheter must be withdrawn until the radio-contrast marker on the proximal end of the thrombectomy device is completely exposed, and the stent should be left in place for 5 minutes after release.

Finally, the thrombectomy device and the microcatheter 80 are withdrawn as a unit to carry the thrombus 90 out, as can be seen in FIG. 7, and during withdrawal, the following should be noted:

1. the initial speed is as slow as possible, so that possible instruments are prevented from being locked with surrounding structures, and the diameter of the bracket can be reduced by using the matched grasping part 11;

2. when a blood vessel part particularly meandering or with obvious diameter change is encountered, the withdrawal speed is slightly reduced, and the possibility of escape of thrombus is reduced.

The embodiments of the present invention are disclosed as the preferred embodiments, but not limited thereto, and those skilled in the art can easily understand the spirit of the present invention and make various extensions and changes without departing from the spirit of the present invention.

Claims

1. The utility model provides a diameter and adjustable thrombectomy device of length which characterized in that: including controller (10), conveying seal wire (20) and a plurality of cage support unit (30), set for near controller (10) one end and be the near-end, keep away from controller (10) one end and be the distal end, wherein:

the controller (10) is provided with a gripping part (11) and a regulating button (12) arranged in the gripping part (11);

the conveying guide wire (20) is externally connected with at least one ball cage unit (30), one end of the conveying guide wire is fixedly connected with the regulating button (12), and the other end of the conveying guide wire is connected with the soft guide head (70);

each cage support unit (30) is provided with a near-end central conveying guide hole (31) and a far-end central conveying guide hole (32) at two ends respectively for supplying and conveying guide wires (20) to penetrate and be fixedly connected, and a plurality of near-end traction through holes (33) and a plurality of far-end traction through holes (34) are respectively arranged along the outer sides of the near-end central conveying guide hole (31) and the far-end central conveying guide hole (32);

and the proximal end of the traction guide wire (40) is fixedly connected with the control button (12), the farthest end of the traction guide wire is fixedly connected with the traction through holes (31) of the cage support units (30) corresponding to the traction guide wire, and the traction guide wire penetrates through a plurality of proximal traction through holes (33) and a plurality of distal traction through holes (34) of all the cage support units (30) between the corresponding cage support units (30) and the controller in a clearance-keeping manner.

2. The embolectomy device of claim 1, wherein: and the delivery guide wire (20) is fixedly connected with the proximal end central delivery guide hole (31) of each cage support unit (30) and passes through the distal end central delivery guide hole (32) with a gap.

3. The embolectomy device of claim 2, wherein: each cage support unit (30) is provided with developing marks (50, 60) close to the proximal end of the conveying guide wire (20) and the outer side close to the distal end of the traction guide wire (40).

4. The embolectomy device of claim 1, wherein: the number of the traction guide wires (40) of each cage support unit (30) is 2-6.

5. The embolectomy device of any of claims 1-4, wherein: each cage support unit (30) is fixedly connected with the conveying guide wire (20) or the traction guide wire (40) by the laser welding and the high polymer material fusion welding.

6. The embolectomy device of claim 5, wherein: the soft guide head (70) is of a J-shaped structure.

7. The embolectomy device of claim 6, wherein:

the gripping part (11) of the controller (10) is also provided with a scale size (13), and the scale size (13) is matched with the regulating button (12) to accurately regulate the strokes of the conveying guide wire (20) and the traction guide wire (30).

8. The embolectomy device of claim 1, wherein: the free end of a soft guiding head (70) at the end of the delivery guide wire protrudes out of the most distal end of the cage support unit.

9. The embolectomy device of claim 5, wherein: each cage support unit (30) is made of a plurality of ribs (35) which are bent and crossed, and the two ends of each cage support unit are gathered to form an overall ellipsoidal-like structure, and meanwhile, the outer surface of each cage support unit (30) is covered with a polymer hydrophilic coating.

10. The embolectomy device of claim 9, wherein: the plurality of ribs (35) of each cage support unit (30) sequentially comprise a supporting part (351), a bending part (352) and a traction hook part (353) from the proximal end to the distal end, the diameter of the bending part (352) is larger than that of the supporting part (351) and that of the traction hook part (353), and the length of the bending part (352) in the conveying direction of the conveying guide wire (20) is larger than that of the supporting part (351) and that of the traction hook part (353).