CN111358526A

CN111358526A - Novel thrombus taking-out support and thrombus taking-out device

Info

Publication number: CN111358526A
Application number: CN201811596154.6A
Authority: CN
Inventors: 王大伟
Original assignee: Suzhou Boxin Medical Technology Co ltd
Current assignee: Suzhou Boxin Medical Technology Co ltd
Priority date: 2018-12-26
Filing date: 2018-12-26
Publication date: 2020-07-03

Abstract

The invention relates to the field of medical instruments, in particular to a novel thrombus taking-out support and a thrombus taking-out device with the thrombus taking-out support, wherein the thrombus taking-out support comprises a support body which is self-expanded along the circumferential direction of a longitudinal axis of the support body, the support body consists of a plurality of spherical support units, support rods of the spherical units have higher radial supporting force and form a three-dimensional structure with nodes of the spherical units of the support, and the support rods can be quickly embedded into thrombus and anchored in blood vessels, so that the thrombus capturing stability can be increased, and the possibility of thrombus slippage can be reduced; the developing material with the non-perspective ray material penetrates through the whole bracket from the far end of the bracket to the near end of the bracket, and the effective length of the embolectomy bracket can be accurately identified by the two ends of the bracket, the spherical units of the bracket and the bracket rod. The embolectomy support that is linked to each other by a plurality of ball-type cell cube can reduce the invalid working length of support, effectively improves the compliance and the adherence of support body, is favorable to improving doctor's simple operation nature like this.

Description

Novel thrombus taking-out support and thrombus taking-out device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a thrombus taking-out support and a thrombus taking-out device with the thrombus taking-out support.

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 the treatment time window, strictly requires that patients arrive at hospitals within 3 to 4.5 hours from illness to receive related treatment, has a plurality of limitations on medicaments, 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: if the working part of the current thrombus taking device is not designed with a design for effectively preventing thrombus from falling off, 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 taking device cannot adhere to the intracranial complex-bent blood vessel well, so that the thrombus is easy to fall off, and the cerebral vessels are easy to spasm; 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 thrombus taking support, which solves the problems that the radial supporting force is insufficient when thrombus is captured in the prior art and the thrombus is easy to fall off when a support body is withdrawn by the design of a plurality of spherical unit structures.

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:

the utility model provides a novel thrombectomy support, includes along its axis of ordinates circumference autologous expanded support body, the support body is linked to each other by a plurality of support ball-type unit bodies, is fixed with the development structure that non-perspective ray material made on every support ball-type unit node and the cradling piece, the support body includes distal region and the near-end region that is connected with the propelling movement silk, also be fixed with the development structure that non-perspective ray material made on distal region and the near-end region.

Preferably, the number of the bracket spherical units on the bracket is 3-10.

Preferably, the number of the support rods attached to the wall of each support spherical unit body on the support in the circumferential direction is 5.

Preferably, the developing structure on the stent is a platinum wire, the platinum wire is wound around the distal region of the stent and then wound along the stent rod, each spherical stent unit node is also wound and finally wound to the proximal region of the stent, and the spherical stent unit node is spirally wound along the longitudinal direction of the stent.

Preferably, the developing structures on the stent are platinum wires and platinum-iridium alloy rings, the platinum-iridium alloy rings are adopted on the far end, the near end and the spherical unit nodes of the stent, the platinum wires penetrate through the platinum-iridium alloy rings from the far end area of the stent, and are wound along the stent rod close to the bottoms of the spherical units, the platinum-iridium alloy rings between every two spherical stent units pass through in a penetrating mode, and finally, the platinum wires are spirally formed along the longitudinal direction of the stent in the near end area of the stent.

Preferably, the screw rod at the far end of the bracket and the platinum wire of the developing structure are welded together by laser welding.

Preferably, the lead screw, the developing structure platinum wire and the pushing wire at the proximal end of the bracket are welded together by laser welding.

Preferably, the medical polymer film coated on the distal end region and the proximal end region of the stent adopts PEBAX.

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

The invention has the beneficial effects that:

a novel thrombus taking-out support and a thrombus taking-out device with the thrombus taking-out support comprise a support body which is self-expanded along the circumferential direction of a longitudinal axis of the support body, wherein the support body consists of a plurality of spherical support units, a developing material of an opaque ray material penetrates through the whole support from the far end of the support to the near end of the support, and the developing material comprises two ends of the support, spherical structure unit nodes of the support and a support rod; the stent rod of the stent spherical unit has higher radial supporting force, the stent rod can be quickly embedded into thrombus and anchored to a blood vessel, and a three-dimensional conical structure is formed at the node of the stent spherical unit to increase the contact surface for capturing the thrombus, so that the thrombus-taking stent can be in more three-dimensional contact with the thrombus, the stability for capturing the thrombus can be increased, the possibility of thrombus slippage can be reduced, and the thrombus-taking effect is better; the developing structures on the two sphere knowns and the support rod can make the shapes of the thrombus taking support and the thrombus more clear in the thrombus taking process, accurately mark 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, thereby being beneficial to the operation and judgment of doctors; 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 flexibility and adherence of the support body are effectively improved, the operation and judgment of doctors are facilitated, and the success rate of thrombus removal of the support is effectively improved.

Drawings

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

FIG. 2 is a schematic structural view of a thrombectomy stent provided in the practice of the present invention after heat treatment;

FIG. 3 is a schematic structural view of a thrombectomy support provided in the practice of the present invention;

FIG. 4 is a schematic structural diagram of a stent spherical unit of the thrombus extraction device provided by the implementation of the invention;

FIG. 5 is a schematic structural view of a thrombus removal device according to the present invention

In the figure:

100 is a bracket body; 101 is the distal end of the stent; 102 is the proximal end of the stent; 103 is a bracket ball-shaped unit; 104 is a bracket spherical unit node; 105 is a developing structure; 106 is a support rod; 107 is a push wire; 200 microcatheter.

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, and an implementation example is shown in fig. 1 to 3, the thrombus removal stent 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 101, a stent ball-shaped unit 103, a stent unit node 104, a developing structure 105 and a proximal end area 102 connected with a pushing wire 107 which are connected in sequence, and the whole stent body 100 is an effective working section.

In the present embodiment, referring to fig. 3, there are visualization structures 105 in the distal region 101, the stent ball-type cell nodes 104, and the proximal region 102 of the stent.

After the pathological change position is arrived at support body 100, support body 100 is released from microcatheter 200, the biggest cradling piece 106 of the circumference diameter that radial support force is stronger, can anchor the vascular wall rapidly and imbed the thrombus, the stability that the thrombus was caught has been increased, fix inside the thrombus from support ball type unit node 104 to the cradling piece 106 of vascular wall, can more and grasp the thrombus firmly, the possibility that the thrombus escaped has been reduced, support body 100 comprises a plurality of support ball type units 103 simultaneously, the compliance of support body 100 has effectively been improved, only the biggest cradling piece 106 of several circumference diameters contacts with the vascular wall, be for the excessive stimulation of less support to the vascular wall, avoid vasospasm.

In addition, through the laser welding mode, a plurality of support rods 106 and the push wire 107 are welded together, and the push wire 107 can be located at the center of the longitudinal circumference of the support body 100, so that the situation that the whole pipe diameter is reduced or kinked due to the fact that the support body 100 is influenced by the withdrawing force in the withdrawing process of the proximal end region 102 can be effectively prevented. The welding design of the support rods 106 and the pushing wires 107 of the plurality of support bodies 100 can effectively disperse the withdrawing force on the circumference of the support bodies 100, and the influence of the withdrawing force on the support bodies 100 is reduced, so that the phenomenon that thrombus is easy to fall off in the taking-out process is avoided. 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 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. 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 the developing structure 105 is changed from a cylinder fixed on the stent far end 101, the stent ball-type unit node 104 and the stent near end 102 in the first embodiment into a wire fixed on the stent far end 101, the stent rod 106, the stent ball-type unit node 104 and the stent near end 102 in a winding manner.

The thickness or the diameter of the developing structure is 0.02-0.15mm, preferably 0.03-0.1mm, the thickness setting can ensure that the diameter and the length of the blood vessel and the thrombus can be clearly marked when the thrombus is removed, the non-perspective ray material for manufacturing the developing structure can be saved to the maximum limit, and the purpose of saving the cost is achieved.

EXAMPLE III

The invention also provides a thrombus extraction device, which comprises the thrombus extraction support described in any embodiment, wherein a micro catheter 200 capable of pressing the thrombus extraction support into a thrombus extraction support is sleeved outside the push wire 107, the micro catheter 200 is connected with an introducing sheath tube through a micro catheter connecting piece, the support body 100 is connected with the push wire 107, and the connection mode is physical winding, physical extrusion, medical adhesion, laser welding, high polymer material fusion welding 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 a guiding sheath in advance, the guiding sheath is connected with a connecting piece of the micro catheter 200 through the guiding catheter, the pushing wire 107 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 the accurate alignment of the pushing and pulling actions can be realized through the pushing wire, thereby realizing the conversion between the compression state and the release state.

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 by pushing the wire 107 to the position of the thrombus determined by the contrast or other diagnostic means, 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 vessel wall, then the pushing wire 107 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 107 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. The utility model provides a novel thrombectomy support, its characterized in that includes along its axis of ordinates circumference autologous expanded support body, the support body is linked to each other by a plurality of support ball-type unit bodies, is fixed with the development structure that non-perspective ray material made on every support ball-type unit node and the cradling piece, the support body includes distal region and the near-end region that is connected with the propelling movement silk, also be fixed with the development structure that non-perspective ray material made on distal region and the near-end region, it has medical polymer membrane to wrap up on distal region and near-end region.

2. The embolectomy support of claim 1, wherein the number of support ball-type units is 1-20.

3. The embolectomy support of claim 1, wherein the spacing between the spherical cells of the support is 0-10 mm.

4. The embolectomy support of claim 1, wherein the number of circumferential adherence support rods of the spherical unit bodies of the support is 3-15, and the number of support rods on each spherical unit body of the support can be the same or different.

5. The embolectomy support of claim 1, wherein the spherical cell body shape of the support is spherical, ellipsoidal, prolate ellipsoidal or a symmetrical conical structure.

6. The developing structure of claim 1, wherein the developing structure is a metal wire made of a medical metal such as platinum wire, gold wire, platinum-iridium alloy wire, tantalum wire, etc.

7. A wire according to claim 6, wherein the wire has an outer diameter of 0.01mm to 0.5 mm.

8. The developing structure of claim 1, wherein the developing structure between the two ends of the stent and the spherical units of the stent is a torus or a cylinder, and the developing structure is made of medical heavy metals such as platinum, gold, platinum-iridium alloy, tantalum and the like.

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

10. The embolectomy support of claim 1, wherein the visualization structure is fixed by physical entanglement, physical extrusion, medical adhesive, laser welding, fusion welding of polymeric materials, and the like.

11. An embolectomy device comprising the embolectomy stent of any of claims 1-10, further comprising an introducer sheath, a microcatheter, and a push wire;

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

the 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.