CN112022282A

CN112022282A - Toper is got and is tied support and thrombus remove device

Info

Publication number: CN112022282A
Application number: CN201910479089.7A
Authority: CN
Inventors: 王大伟; 李虎
Original assignee: Suzhou Boxin Medical Technology Co ltd
Current assignee: Suzhou Boxin Medical Technology Co ltd
Priority date: 2019-06-04
Filing date: 2019-06-04
Publication date: 2020-12-04

Abstract

The invention relates to the field of medical instruments, in particular to a conical thrombus taking-out support and a thrombus taking-out device with the same. The conical thrombus removal support connected by the spherical unit bodies is beneficial to improving the flexibility and adherence of the support, reducing the stimulation of the support to blood vessels in the thrombus removal process and reducing the probability of vasospasm; the three-dimensional structure among the spherical units of the stent increases the contact surface between the stent and thrombus, improves the stability of thrombus capture and reduces the possibility of thrombus escape; the two ends of each spherical unit and the bracket rod are provided with the developing devices, which is helpful for doctors to judge the relative position of the thrombus taking bracket and the thrombus and the releasing and expanding condition of the thrombus taking bracket, and is favorable for improving the success rate of thrombus taking of the bracket.

Description

Toper is got and is tied support and thrombus remove device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a conical thrombus removal support and a thrombus removal device with the same.

Background

Stroke is also called stroke, and stroke is a group of acute cerebrovascular diseases which take ischemic brain tissue and hemorrhagic injury symptoms as main clinical manifestations, and seriously jeopardizes the life health and the quality of life of the public due to the characteristics of high morbidity, high mortality, high disability rate, high recurrence rate, high economic burden and the like. At present, the incidence rate of stroke in China is rising at a speed of 8.7% per year, and the number of people dying from stroke in China exceeds the number of tumor and cardiovascular diseases per year, so that the disease becomes the first cause of death.

The stroke is divided into ischemic stroke and hemorrhagic stroke, wherein the ischemic stroke accounts for 70 to 80 percent, in patients with ischemic stroke, the consequence caused by intracranial large vessel occlusion caused by various reasons is the most serious and has been the difficulty of treatment, and the current treatment methods comprise venous drug thrombolysis, arterial drug thrombolysis, intravascular mechanical thrombus extraction, combined use of a plurality of methods and the like. The artery and vein thrombolysis is a conventional method for treating acute ischemic stroke, but the method has high requirements on a treatment time window, strictly requires that a patient arrives in a hospital to receive related treatment within 3-4.5 hours from illness, has a plurality of limitations on medicines, and has low blood vessel recanalization rate of the acute ischemic stroke caused by the most serious large blood vessel occlusion.

Mechanical arterial thrombectomy devices have gained widespread attention because of the following advantages: rapid recanalization, lower bleeding conversion and a prolonged stroke intervention time window. Has satisfactory clinical effect on the revascularization of acute ischemic stroke caused by the occlusion of large blood vessels. Merci Retrieval (2004) and Penumbra string Systems (2008) were approved by the U.S. Food and Drug Administration (FDA) as first generation mechanical embolectomy devices.

However, in the case of mechanical embolectomy devices, many problems still remain in the embolectomy process: for example, the outer diameter and the radial supporting force of the current thrombus removal device are not matched with the inner diameter of a blood vessel, so that the blood vessel is easily damaged in the thrombus removal process, and other complications are brought; meanwhile, the working part of the stent is not designed with a design for effectively preventing thrombus from falling off, so that the thrombus is easy to fall off in the thrombus taking process; the flexibility of the thrombus taking device is relatively poor, and the thrombus cannot adhere to the intracranial complex-bent blood vessel well, so that the thrombus is easy to fall off; the existing thrombus taking device has certain invalid working length, which brings certain inconvenience to doctors in clinical use and can not accurately determine the near end of the effective working length of the bracket; the thrombus removal device is only provided with a single developing point, and the releasing and expanding conditions of the stent cannot be judged in a book, so that the operation of a doctor in the operation process is not facilitated.

Disclosure of Invention

The invention aims to provide a conical thrombus removal support, which solves the problems that the support damages a blood vessel, thrombus escapes and the adherence of the support is poor when the thrombus is captured in the prior art by designing a conical structure with a plurality of spherical unit structures and large near ends and small far ends.

Still another object of the present invention is to provide a thrombus extraction device having the above-described thrombus extraction stent.

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

including along its axis of ordinates circumference autologous expanded support body, the support body is linked to each other by a plurality of spherical unit bodies of support, and the support external diameter of spherical unit reduces from nearly heart-end to far away heart-end gradually, and whole support is nearly big-end-up's toper structure. Developing structures made of non-perspective ray materials are fixed between each spherical support unit and on the support rods, the support body comprises a far-end area and a near-end area connected with the push wires, the developing structures made of the non-perspective ray materials are also fixed on the far-end area and the near-end area, and medical polymer films are wrapped on the far-end area and the near-end area.

Preferably, the stent body is connected by a plurality of stent spherical unit bodies, the outer diameter of the stent of the spherical unit is gradually reduced from the proximal end to the distal end, and the whole stent is in a conical structure with a large proximal end and a small distal end.

Preferably, the support rod of each spherical unit structure comprises a fixing part of the developing device, and the fixing part is a side rod.

Preferably, the number of the spherical units of the bracket is 2-6.

Preferably, the spacing between the spherical units of the support is 5-15mm, the number of the support rods on each spherical unit body of the support can be the same, or the number of the support rods can be correspondingly smaller as the outer diameter of the spherical unit structure is reduced.

Preferably, the number of the support rods attached to the circumferential wall of the spherical unit bodies of the supports is 3-5, the number of the support rods on each spherical unit body of the supports is the same, and the number of the support rods is correspondingly smaller along with the reduction of the outer diameter of the spherical unit structure.

Preferably, the developing device comprises a developing point, and the developing point is made of a silk thread and sleeved on a fixing part of the developing device in a spring shape.

Preferably, the developing fixing part comprises 3 to 5 supporting rods of each spherical unit structure.

Preferably, the shape of the spherical unit body of the bracket is an ellipsoid.

Preferably, the developing device is a spring ring made of silk thread, and the material of the spring ring is platinum-iridium alloy.

Preferably, the outer diameter of the platinum-iridium alloy wire is 0.04mm to 0.08 mm.

Preferably, the medical polymer film coated on the distal end area and the proximal end area of the stent is PET.

Preferably, the support rod and the developing structure platinum-iridium alloy wire are welded together by laser welding.

The utility model provides a thrombus remove device, includes above arbitrary toper thrombectomy support, the proximal end region of toper thrombectomy support is connected with the propelling movement silk, the outside cover that pushes away the silk is equipped with can impress thrombectomy support the little pipe in it, little pipe is connected with leading-in sheath pipe through little pipe connection spare.

The invention has the beneficial effects that:

the utility model provides a toper thrombus takes out support and has thrombus remove device of this thrombectomy support, includes along its axis of ordinates circumference from expanded support body, the support body comprises a plurality of spherical units, and spherical unit's support external diameter reduces from nearly heart-end to far away heart-end gradually, and whole support is nearly big-end-up's toper structure. The conical thrombus removal support is connected by the spherical unit bodies, so that the flexibility and adherence of the support are improved, the stimulation of the support to blood vessels in the thrombus removal process is reduced, and the vasospasm probability is reduced; the three-dimensional structure among the spherical units of the stent increases the contact surface between the stent and thrombus, improves the stability of thrombus capture and reduces the possibility of thrombus escape; the two ends of each spherical unit and the bracket rod are provided with the developing devices, which is helpful for doctors to judge the relative position of the thrombus taking bracket and the thrombus and the releasing and expanding condition of the thrombus taking bracket, and is favorable for improving the success rate of thrombus taking of the bracket.

Drawings

FIG. 1 is a schematic structural diagram illustrating a planar expanded view of a tapered thrombectomy stent provided in the practice of the present invention;

FIG. 2 is a first schematic structural view of a structural side profile of a tapered thrombectomy stent provided in the practice of the present invention;

FIG. 3 is a second structural schematic view of the structural side profile of a tapered thrombectomy stent provided in the practice of the present invention;

FIG. 4 is a third schematic structural view of the structural side profile of a tapered thrombectomy holder provided in the practice of the present invention;

FIG. 5 is a schematic side view of a spherical unit structure of a tapered thrombectomy stent provided in the practice of the present invention;

FIG. 6 is a schematic structural diagram of a cross section of a spherical unit structure of a conical embolectomy stent provided by the implementation of the invention;

FIG. 7 is a first schematic structural view of a first developer mounting portion on a support rod of a tapered stud removal support in accordance with an embodiment of the present invention;

FIG. 8 is a second schematic structural view of a second developer mounting portion on a support bar of a tapered thrombectomy support provided in accordance with an embodiment of the present invention;

FIG. 9 is a third schematic structural view of a developer mounting portion on a support bar of a tapered thrombectomy support provided in the practice of the present invention;

FIG. 10 is a fourth schematic structural view of a developer mounting portion on a support bar of a tapered thrombectomy support provided in accordance with implementations of the present invention;

FIG. 11 is a schematic structural view of a conical thrombus removal device provided in the practice of the present invention.

In the figure:

100 is a bracket body, 101 is a bracket near end, 102 is a bracket effective working section, 103 is a bracket far end, 104 is a bracket spherical unit, 105 is a developing device mounting part, 106 is a bracket rod, 107 is a bracket spherical unit node, 108 is a developing device, 109 is a push wire

200 micro-catheter

Detailed Description

In order to make the technical problems solved, the technical solutions adopted and the technical effects achieved by the present invention clearer, the technical solutions of the present invention are further described below by way of specific embodiments with reference to the accompanying drawings. For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end proximal to the operative end and "distal" refers to the end distal to the operative end.

Example one

The invention provides a thrombus removal stent, which is shown in an implementation example in fig. 1, 2 and 5-7 and comprises a stent body 100 which is self-expanded along the circumferential direction of the longitudinal axis of the stent body, wherein the stent body 100 comprises a distal end area 103, a stent effective working section 102, a stent spherical unit 104, a developing device mounting part 105, a stent rod 106, a stent unit node 107, a developing device 108 and a proximal end area 101 connected with a pushing wire 109, which are connected in sequence, and the whole stent body 100 is an effective working section.

In this embodiment, referring to fig. 1, 2, 5, there are developers 108 in the distal region 103 of the stent, the stent spherical unit nodes 107, the developer mount 105, and the proximal region 101.

After the support body 100 reaches the pathological change position, the support body 100 is released from microcatheter 200, the biggest support rod 106 of the circumferential diameter that radial support force is stronger, can anchor the vascular wall rapidly and imbed the thrombus, the stability of thrombus capture has been increased, fix inside the thrombus from support spherical unit node 107 to the support rod 106 of vascular wall, can more and grasp the thrombus firmly, the possibility that the thrombus escapes has been reduced, simultaneously support body 100 comprises a plurality of spherical units of support 104 and support unit node 107, the compliance of support body 100 has effectively been improved, only the biggest support rod 106 of several circumferential diameters contacts with the vascular wall, simultaneously the effective working section 102 of support is less gradually from the external diameter of near-end to distal end spherical unit of support 104, be for the excessive stimulation of less support to the vascular wall, avoid vasospasm.

Penetrating a plurality of support rods 106 of the distal region 103 into a developing device 108, and fixing the developing device 108 at the distal end of the support body 100 by means of laser welding; the developing device 108 is fitted over the developing device mounting portion 105 and the holder unit node 107 on the holder bar 106, and then the developing structure is fixed by means of laser welding, too.

In addition, still through the mode of laser welding, with a plurality of cradling pieces 106 with the push wire 109 welded together, and the push wire 109 can be located the center of the support body 100 longitudinal circumference, can effectively prevent near-end region 101 in the process of withdrawing, because of support body 100 receives the influence of withdrawal force, whole pipe diameter diminishes, or the kink. The welding design of the stent rods 106 and the pushing wires 109 of the stent bodies 100 can effectively disperse the withdrawing force on the circumference of the stent body 100, and reduce the influence of the withdrawing force on the stent body 100. The traction force of the stent body 100 is concentrated on the extension line where the pushing wire is located, and the tube diameter of the stent body 100 is guaranteed to be unchanged.

The developing device 108 is arranged on the stent proximal end 101, the stent distal end 103, the stent spherical unit 104 and the stent spherical unit node 107 of the stent body 100, so that a doctor can judge the positions of the stent body 100 and thrombus in the embolectomy operation process, and can judge the expansion condition of the stent spherical unit after the stent body 100 is released, thereby improving the embolectomy success rate.

Referring to fig. 5 and 6, the contact area between the stent rod 106 of the stent body 100 and the blood vessel is small, the contact area with the thrombus is large, and meanwhile, the mesh structure in the middle area of the cross section of the stent body 100 ensures that the thrombus can be effectively captured while the stimulation of the stent body 100 to the inner wall of the blood vessel is reduced, the escape probability of the thrombus is reduced, the recanalization rate of the blocked blood vessel is increased, and the success rate of the operation is increased.

The stent body 100 may be made of a nickel-titanium material or a polymer material, specifically, may be formed by laser cutting a nickel-titanium tube, or may be formed by laser cutting a nickel-titanium plate and then crimping and heat setting, or may be further formed by weaving a nickel-titanium wire, or may be formed by processing an elastic plastic material.

Example two

Fig. 3 shows a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that after the stent body 100 is heat-treated and shaped, the spherical unit structure 104 of the stent changes from the ellipsoidal shape in the first embodiment to the fusiform shape.

EXAMPLE III

Fig. 4 shows a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that after the stent body 100 is heat-treated and set, the spherical unit structure 104 of the stent changes from the ellipsoidal shape in the first embodiment to the spherical shape.

Example four

Fig. 8 shows a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that the developing device mounting portion 105 of the rack bar 106 is changed from the inward-biased bar to the linear bar in the first embodiment.

EXAMPLE five

Fig. 9 shows a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that the developing device mounting portion 105 of the rack bar 106 is a slot hole formed by the inner bias side bar in the first embodiment. The developing device 108 may be fixed to the developing device mounting portion 105 in a damascene manner when it is a strip-shaped sheet; the developing device 108 may be fixed to the developing device mounting portion 105 in a winding manner when it is a wire.

EXAMPLE six

Fig. 10 shows a second embodiment, wherein the same or corresponding parts as in the first embodiment are provided with the same reference numerals as in the first embodiment. For the sake of simplicity, only the differences between the second embodiment and the first embodiment will be described. The difference is that the developing device mounting portion 105 of the rack bar 106 is a round hole from the inner bias side bar in the first embodiment. The developing device 108 may be fixed to the developing device mounting portion 105 in a damascene manner when it is a circular sheet; the developing device 108 may be fixed to the developing device mounting portion 105 in a winding manner when it is a wire.

EXAMPLE seven

The invention also provides a thrombus extraction device, which comprises the thrombus extraction support described in any one of the above embodiments, referring to fig. 11, a microcatheter 200 capable of pressing the thrombus extraction support into a thrombus extraction support is sleeved outside the push wire 109, the microcatheter 200 is connected with an introduction sheath tube through a microcatheter connecting piece, and the support body 100 is connected with the push wire 109 in a physical winding manner, a physical extrusion manner, a medical adhesive manner, a laser welding manner, a high polymer material melting welding manner and the like. The development structures are distributed on the bracket body 100 and used for observing whether thrombus falls off in the process of capturing and withdrawing thrombus in real time during thrombus extraction so as to guide specific thrombus extraction microscopic operation and ensure that thrombus extraction is more accurate. The structure and the working principle of the embolectomy support refer to the above embodiments, and are not described in detail herein.

When thrombus taking preparation work is carried out, the stent body 100 is firstly compressed into an introducing sheath in advance, the introducing sheath is connected with a connecting piece of the micro catheter 200 through an introducing catheter, the pushing wire 109 is pushed, the stent body 100 can smoothly enter the lumen of the micro catheter 200, and then the stent body 100 is conveyed to the position of the thrombus determined according to radiography or other diagnosis means through the micro catheter 200, so that the stent body 100 is released at the position of the vascular lesion to form a plurality of inverted conical lumens, and accurate push-pull action alignment can be realized through the pushing wire, and therefore conversion between a compression state and a release state is realized.

During interventional therapy, the microcatheter 200 is delivered to the lesion and passed through the thrombus to fix the microcatheter. The stent body 100 is pushed to the position of the thrombus determined by radiography or other diagnostic means by pushing the wire 109, the microcatheter 200 is withdrawn to release the stent body 100 at the distal end, the stent body 100 is released at the distal end to expand and anchor the blood vessel wall, then the pushing wire 109 is slowly pushed forward, and simultaneously the microcatheter 200 is withdrawn under the reaction force to release the binding force of the microcatheter 200, and the process is repeated for a plurality of times until the stent body 100 is completely expanded and released.

Due to the combined action of the elasticity and the releasing method of the shape memory material, the thrombus taking bracket can be completely embedded into thrombus, after a certain time, the push wire 109 is pulled back, the thrombus taking bracket is withdrawn to capture the thrombus until the thrombus taking bracket and the micro catheter 200 are withdrawn and taken out of the body, and the whole thrombus taking process is completed. The stent body 100 as a whole is crimped and introduced into the sheath, and then introduced into the micro catheter 200, that is, the stent body 100 is delivered to the lesion site through the micro catheter 200.

It should be understood that the above-described embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. Any modification, equivalent replacement or improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A conical thrombus removal support is characterized by comprising a support body which is self-expanded along the circumferential direction of a longitudinal axis of the support body, wherein the support body is connected by a plurality of spherical support unit bodies, the outer diameter of the support of the spherical units is gradually reduced from a proximal end to a distal end, and the whole support is in a conical structure with a large proximal end and a small distal end; a certain number of developing structures made of non-perspective ray materials are fixed between each spherical support unit and on the support rods, the support body comprises a far-end area and a near-end area connected with the push wires, the developing structures made of the non-perspective ray materials are also fixed on the far-end area and the near-end area, and medical polymer films are wrapped on the far-end area and the near-end area.

2. The tapered embolectomy stent of claim 1, wherein the stent body is formed by connecting a plurality of spherical stent unit bodies, the outer diameter of the spherical unit stent gradually decreases from the proximal end to the distal end, and the whole stent is in a tapered structure with a large size and a small size.

3. The tapered thrombectomy support of claim 1, wherein the support rod of each spherical unit structure comprises a fixing part of the developing device, and the fixing part is a side rod, or a round hole, a square hole or a long groove.

4. The tapered embolectomy stent of claim 1, wherein the number of stent spherical elements is 1-10.

5. The tapered embolectomy stent of claim 1, wherein the spacing between the spherical elements of the stent is 0-20mm, the spacing between the spherical elements may be the same, or the spacing between the spherical elements may decrease as the outer diameter of the spherical element structure decreases.

6. The tapered embolectomy stent of claim 1, wherein the number of circumferentially adherent stent struts of the balloon-shaped unit body of the stent is 3-10, the number of stent struts on each balloon-shaped unit body of the stent can be the same, or the number of stent struts can be correspondingly smaller as the outer diameter of the balloon-shaped unit structure is reduced.

7. The tapered embolectomy support of claim 3, wherein the developing device comprises a developing point, and the developing point is a ring sleeved on a fixing part of the developing device; or the silk thread is made into a spring shape and sleeved on the fixing part of the developing device; alternatively, the developing device is made into a sheet shape and embedded in a fixing portion of the developing device.

8. The tapered embolectomy holder of claim 3, wherein the number of developing holders is 3 to 10 per one holder rod of the spherical unit structure.

9. The tapered embolectomy stent of claim 4, wherein the spherical unitary body shape of the stent is ellipsoidal, fusiform, or spherical.

10. The developing device according to claim 7, wherein the developing device is a coil, a disk or a strip-shaped sheet made of a medical metal such as platinum, gold, platinum-iridium alloy, tantalum, etc. and made of a wire.

11. A wire according to claim 10, wherein the outer diameter of the wire is 0.02mm to 0.1mm, preferably 0.04mm to 0.08 mm; the thickness of the wafer is 0.02 mm-0.1 mm, preferably 0.04 mm-0.08 mm; the thickness of the sheet is 0.02mm to 0.1mm, preferably 0.04mm to 0.08 mm.

12. The medical polymer film according to claim 1, wherein the polymer coating layer is made of a medical polymer material such as PEBAX, PET, TPU, PTFE, PP, or the like.

13. The tapered embolectomy stent of claim 7, wherein the visualization structure is fixed by physical entanglement, physical extrusion, medical gluing, laser welding, soldering/silver/gold welding, fusion welding of polymeric materials, and the like.

14. An embolectomy device comprising the embolectomy stent of any of claims 1-13, further comprising an introducer sheath, a microcatheter, and a push wire;

the proximal end of the conical thrombus removal support is connected with the pushing wire, and the mounted thrombus removal support and the pushing wire are pressed and guided into the guide sheath;

the tapered thrombus taking support can enter the micro-catheter from the guide sheath by pushing the push wire and is delivered to the thrombus by the micro-catheter to be released.