阅读说明：本技术 一种血流导向支架输送系统 (Blood flow guide support conveying system ) 是由 吴重草 刘振全 贾晶 孙冰 于 2020-09-04 设计创作，主要内容包括：本发明公开了一种血流导向支架输送系统,包括外鞘管、推送导丝、中空内轴、束缚瓣、束缚瓣固定件、近内轴固定点、远内轴固定点及第一显影元件、第二显影元件和血流导向支架；所述中空内轴套装在推送导丝外侧；所述束缚瓣经束缚瓣固定件固定套装在中空内轴外侧。本发明的有益效果在于,首先,本发明的导向支架输送系统没有改变现有输送装置的外观形状和尺寸大小,仍然保持系统具备的灵活性,能够通过现有的医疗技术手段进行操作；其次,本发明的导向支架输送系统在操作过程中,血流导向支架被束缚瓣以摩擦力束缚在中空内轴上,由于中空内轴不随导丝发生不可控旋转,使得支架在输送过程中不发生扭转,在迂曲血管中具有更好的释放成功率。(The invention discloses a blood flow guide bracket conveying system which comprises an outer sheath tube, a push guide wire, a hollow inner shaft, a constraint valve fixing piece, a near inner shaft fixing point, a far inner shaft fixing point, a first developing element, a second developing element and a blood flow guide bracket, wherein the push guide wire is arranged in the outer sheath tube; the hollow inner shaft is sleeved outside the pushing guide wire; the binding flap is fixedly sleeved outside the hollow inner shaft through the binding flap fixing piece. The invention has the advantages that firstly, the guide bracket conveying system does not change the appearance shape and the size of the prior conveying device, still keeps the flexibility of the system and can be operated by the prior medical technical means; secondly, in the operation process of the guide stent conveying system, the blood flow guide stent is bound on the hollow inner shaft by the binding valve with friction force, and the hollow inner shaft does not uncontrollably rotate along with the guide wire, so that the stent is not twisted in the conveying process, and has better release success rate in a tortuous blood vessel.)

1. A blood flow guide stent conveying system is characterized by comprising an outer sheath (1), a pushing guide wire (2), a hollow inner shaft (3), a constraint flap (4), a constraint flap fixing piece (5), a near inner shaft fixing point (6), a far inner shaft fixing point (7), a first developing element (8), a second developing element (9) and a guide stent (10); the hollow inner shaft (3) is sleeved on the outer side of the pushing guide wire (2); the restraint flap (4) is fixedly sleeved outside the hollow inner shaft (3) through a restraint flap fixing piece (5), and the near inner shaft fixing point (6) and the far inner shaft fixing point (7) are fixed outside the push guide wire (2) and are positioned on two sides of the hollow inner shaft (3); the blood flow guide support (10) is of a cylindrical structure, is sleeved on the outer side of the push guide wire (2), and has one closed end overlapped between the hollow inner shaft (3) and the constraint valve (4); the outer sheath tube (1) is sleeved outside the hollow inner shaft (3), the binding flap (4) and the blood flow guide bracket (10); the first developing element (8) and the second developing element (9) are fixedly arranged at two ends of the hollow inner shaft (3).

2. The blood flow directing stent delivery system of claim 1, wherein: the length of the hollow inner shaft (3) is 3-98% of the distance between the near inner shaft fixing point (6) and the far inner shaft fixing point (7).

3. The blood flow directing stent delivery system of claim 2 wherein: the length of the overlapping section of the binding flap (4) and the hollow inner shaft (3) is 3-100% of the length of the hollow inner shaft (3).

4. The blood flow directing stent delivery system of claim 3, wherein: the length of the overlapping section of the binding flap (4) and the blood flow guide bracket (10) is 1% -95% of the length of the blood flow guide bracket (10).

5. The blood flow directing stent delivery system of claim 1, wherein: the inner diameter of the hollow inner shaft (3) is slightly larger than the outer diameter of the pushing guide wire (2), and the hollow inner shaft is in the form of one of a smooth sleeve, a sleeve subjected to surface treatment, a sleeve with a regular surface structure or a coil formed by winding.

6. The blood flow directing stent delivery system of claim 2 wherein: the hollow inner shaft (3) is made of one or more of metal, alloy or high polymer materials; metals or alloys include, but are not limited to, stainless steel, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy, or cobalt-chromium alloy; polymeric materials include, but are not limited to, polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyamide, polyimide, or nylon.

7. The blood flow directing stent delivery system of claim 1, wherein: the first developing element (8) and the second developing element (9) are radiopaque materials, including but not limited to gold, platinum-tungsten alloy, platinum-iridium alloy or developing high molecular materials.

8. The blood flow directing stent delivery system of claim 3, wherein: the binding valve (4) is of a self-expansion structure, and adopts one of the following shapes in a natural state:

a) a bell shape; or

b) The proximal end is provided with a bell shape of a thin cylinder; or

c) The far end is provided with a bell shape with a thick cylinder shape; or

d) A bell shape with a thin cylindrical shape at the proximal end and a thick cylindrical shape at the distal end, or

e) Frusto-conical, or

f) A truncated cone with a thin cylindrical shape at its proximal end, or

g) A truncated cone with a thick cylindrical shape at its distal end, or

h) The proximal end has a thin cylindrical shape and the distal end has a truncated conical shape with a thick cylindrical shape.

9. The blood flow directing stent delivery system of claim 1, wherein: the binding flap (4) is a single-layer or multi-layer braided fabric formed by braiding filamentous materials.

10. The blood flow directing stent delivery system of claim 1, wherein: the blood flow guiding bracket (10) is a single-layer or multi-layer braided fabric formed by braiding elastic or memory filamentous materials.

Technical Field

The invention relates to the technical field of medical instrument implants, in particular to a blood flow guide stent conveying system.

Background

Intracranial aneurysm is a high-grade cerebrovascular disease, refers to acute blood circulation disorder caused by cerebral aneurysm-like protrusion, and has the risks of tumor body rupture and arterial vascular hemorrhage, and is high in fatality and disability rate and great in harm. Aiming at intracranial aneurysm, common treatment means comprises surgical clamping and intravascular interventional treatment, the risk of craniotomy clamping operation is high, and in recent years, intravascular interventional treatment gradually replaces clamping to become mainstream treatment means by virtue of the advantages of short operation flow, low trauma degree and good clinical prognosis.

Common means for endovascular interventional therapy include intratumoral embolization and blood flow guiding devices, wherein the intratumoral embolization is released into an aneurysm by expandable filler, and the intratumoral blood exchange is reduced by using the space occupying effect of the expandable filler; the blood flow guiding device is generally a dense-mesh stent, is implanted into an endovascular aneurysm through a minimally invasive surgery, reduces blood entering a tumor body by guiding the blood flow direction, induces the tumor body to form thrombus, and reduces the rupture risk of the tumor body. For small-sized or thin-walled aneurysms, the risk that the spring ring cannot enter the aneurysm or the aneurysm ruptures to bleed exists, so compared with intratumoral tamponades, the blood flow guiding device has better effect and higher safety, and is gradually widely applied along with the improvement of the medical science and technology level.

The delivery system of the blood flow guiding device is a device with a series of components working together, and a self-expanding blood flow guiding stent in a sheath is pushed into a catheter or a microcatheter by a guide wire and then delivered and released at an aneurysm. Among the current conveying system, seal wire and propelling movement part are fixed mutually to the position of restriction support in the sheath pipe, but the complicated circuitous of human intracerebral vascular route, uncontrollable rotation can take place at the in-process of marcing for the seal wire, and the seal wire makes it follow the seal wire and takes place to rotate with the restriction of fixed propelling movement part to the support, thereby leads to the support to twist reverse or from expanding incompletely, can not laminate the vascular wall well, can't reach best treatment.

Therefore, in view of the existing problems, it is desirable to provide a blood flow guiding stent delivery system to solve the problem of uncontrollable rotation of the stent.

Disclosure of Invention

1. Technical problem to be solved

The technical problem to be solved by the present invention is to provide a blood flow guiding stent delivery system, wherein the stent is not twisted with the advancement of a guide wire when being pushed in a sheath or a microcatheter, and has a better release success rate in a tortuous blood vessel and a smaller pushing resistance compared with the prior art.

2. Technical scheme

In order to achieve the purpose, the invention provides the following technical scheme: a blood flow guide stent conveying system comprises an outer sheath tube, a pushing guide wire, a hollow inner shaft, a constraint valve fixing piece, a near inner shaft fixing point, a far inner shaft fixing point, a first developing element, a second developing element and a blood flow guide stent; the hollow inner shaft is sleeved outside the pushing guide wire; the constraint valve is fixedly sleeved outside the hollow inner shaft through a constraint valve fixing piece, and the near inner shaft fixing point and the far inner shaft fixing point are fixed outside the pushing guide wire and positioned on two sides of the hollow inner shaft; the guide support is of a cylindrical structure and is sleeved on the outer side of the pushing guide wire, and a closing port at one end is overlapped between the hollow inner shaft and the constraint valve; the outer sheath pipe is sleeved outside the hollow inner shaft, the constraint valve and the guide bracket; the first developing element and the second developing element are fixedly mounted at both ends of the hollow inner shaft.

In the blood flow guide stent delivery system, the length of the hollow inner shaft is 3% to 98% of the distance between the proximal inner shaft fixing point and the distal inner shaft fixing point.

In the blood flow guide stent delivery system, the length of the overlapping section of the restraining flap and the hollow inner shaft is 3% to 100% of the length of the hollow inner shaft.

In the blood flow guide stent delivery system, the length of the overlapping section of the binding flap and the blood flow guide stent is 1% to 95% of the length of the blood flow guide stent.

In the blood flow guiding stent delivery system, the inner diameter of the hollow inner shaft is slightly larger than the outer diameter of the pushing guide wire, and the hollow inner shaft is in the form of one of a smooth sleeve, a sleeve subjected to surface treatment, a sleeve with a regular surface structure or a coil formed by winding.

The blood flow guiding stent delivery system, wherein the material of the hollow inner shaft is one or more of metal, alloy or polymer material; metals or alloys include, but are not limited to, stainless steel, platinum-tungsten alloy, platinum-iridium alloy, nickel-titanium alloy, or cobalt-chromium alloy; polymeric materials include, but are not limited to, polyethylene, polyoxymethylene, polyurethane, polyester, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyamide, polyimide, or nylon.

The blood flow guiding stent delivery system, wherein the first and second imaging elements are made of radiopaque material, including but not limited to gold, platinum-tungsten alloy, platinum-iridium alloy or developable polymer material.

In the above blood flow guiding stent delivery system, the constraining valve is a self-expanding structure, and adopts one of the following shapes in a natural state:

a bell shape; or

The proximal end is provided with a bell shape of a thin cylinder; or

The far end is provided with a bell shape with a thick cylinder shape; or

A bell shape with a thin cylindrical shape at the proximal end and a thick cylindrical shape at the distal end, or

Frusto-conical, or

A truncated cone with a thin cylindrical shape at its proximal end, or

A truncated cone with a thick cylindrical shape at its distal end, or

The proximal end has a thin cylindrical shape and the distal end has a truncated conical shape with a thick cylindrical shape.

In the above blood flow guiding stent delivery system, the constraining petals are single-layer or multi-layer braided fabric formed by braiding filamentous materials.

In the blood flow guiding stent delivery system, the guiding stent is a single-layer or multi-layer braided fabric formed by braiding elastic or memory filamentous materials.

3. Advantageous effects

In conclusion, the beneficial effects of the invention are as follows:

(1) the guide bracket conveying system does not change the appearance shape and the size of the existing conveying device, still keeps the flexibility of the system, and can be operated by the existing medical technical means;

(2) in the operation process of the guide stent conveying system, the blood flow guide stent is bound on the hollow inner shaft by the binding valve with friction force, and the hollow inner shaft does not uncontrollably rotate along with the guide wire, so that the stent is not twisted in the conveying process, and has better release success rate in a tortuous blood vessel.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention without limiting the invention in which:

FIG. 1 is a schematic longitudinal cross-sectional view of the delivery system in a delivery configuration;

FIG. 2 is a schematic cross-sectional view taken at the location A-A shown in FIG. 1;

FIG. 3 is a schematic view of the present delivery system during delivery to transfer a guide stent from a sheath into a microcatheter;

FIG. 4 is a schematic view of the present delivery system in a position for pushing within a curved pipeline;

fig. 5 is a possible embodiment of the present delivery system.

In the figure: 1-an outer sheath tube, 2-a pushing guide wire and 3-a hollow inner shaft; 4-a tethered flap; 5-a restraining flap fastener; 6-near the inner shaft fixing point; 7-distal inner shaft fixation point; 8-a first developing element; 9-a second developing element; 10-a guide bracket; 11-microcatheter, 12-lobe, 13-second hollow inner shaft; 14-middle inner shaft fixation point; 15-a third developing element; 16-fourth developing element.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

As shown in fig. 1, the present invention provides a technical solution: a blood flow directing stent delivery system, the system comprising: (a) an outer sheath tube 1 having a hollow lumen, and capable of accommodating and slidably covering the blood flow guiding stent in a crimped state and a release device thereof; (b) a push guidewire 2 with a distal portion positioned within the lumen of the outer sheath; (c) a hollow inner shaft 3 which is sleeved on the push guide wire 2 and can slide along or rotate around the push guide wire 2, and a binding flap 4 which is fixed on the hollow inner shaft 3 by a binding flap fixing piece 5 in a pressing and holding state; (d) a near inner shaft fixing point 6 and a far inner shaft fixing point 7 which are fixed on the pushing guide wire 2 and used for pushing the hollow inner shaft 3 and limiting the movable range of the hollow inner shaft 3; (e) a first developing member 8 and a second developing member 9 at both ends of the hollow inner shaft for accurate positioning during releasing; (f) the crimped blood flow is directed towards the stent 10, with the proximal end overlapping between the restraining flap 4 and the hollow inner shaft 3.

Further, the movable area of the hollow inner shaft 3 on the push guide wire 2 is defined by a near inner shaft fixing point 6 and a far inner shaft fixing point 7, and the ratio of the length of the hollow inner shaft 3 to the distance between the near inner shaft fixing point 6 and the far inner shaft fixing point 7 is at least 3% and at most 98%.

Further, the crimp flaps 4 in the crimped state in the delivery configuration will partially or completely cover the associated hollow inner shaft 3, wherein the ratio of the length of the overlapping region of the crimp flaps 4 with the hollow inner shaft 3 to the length of the hollow inner shaft 3 is at least 3% and at most 100%; the far end of the restraint flap 4 is overlapped with the near end part of the guide stent 10, wherein the ratio of the length of the overlapped area of the restraint flap 4 and the guide stent 10 to the length of the guide stent 10 is at least 1 percent and at most 95 percent; in their respective non-crimped natural states, the diameter of the distal end of the restraining flap 4 is slightly larger, equal or slightly smaller than the diameter of the proximal end of the guide stent 10.

Furthermore, the restraining flap in the delivery system can be retracted after the guiding stent 10 is partially released from the microcatheter, and can be released again after being repositioned; furthermore, the developing elements 8 and 9 are convenient for doctors to observe the release degree of the guide support 10 in the operation process and judge whether the guide support needs to be withdrawn and repositioned when part of the guide support is released, so that the success rate of the operation can be effectively improved.

Referring to fig. 2, which is a schematic cross-sectional view of the delivery system at a-a in fig. 1, the push guidewire 2 is not connected to the hollow inner shaft 3 and can move relatively.

As shown in fig. 3, which is a schematic view of the present delivery system cooperating with a microcatheter for stent delivery, the distal end of the sheath 1 is sleeved into the proximal end of the microcatheter 11, so that the push guide wire 2 is guided into the proximal head of the microcatheter 11 and can be pushed in the lumen of the microcatheter; further, with the forward pushing of the pushing guide wire 2 and the near inner shaft fixing point 6 fixed thereon, the hollow catheter 3 and the binding flap 4 connected thereto are bound with the blood flow guiding stent 10 and sent into the cavity of the micro-catheter 11, and then the guide wire is withdrawn, the far inner shaft fixing point 7 pushes back the hollow catheter 3 and the binding flap 4, and the blood flow guiding stent 10 is released to the diseased region.

As shown in fig. 4, during the guide wire advancing process, the outer hollow inner shaft near the inner shaft fixing point 6 is contacted with the hollow inner shaft 3 and is advanced by transmitting the pushing force; furthermore, the push guide wire 2 can be twisted for many times in the advancing process, the torque is not transmitted near the inner shaft fixing point 6 outside the hollow inner shaft, and the hollow inner shaft 3 and the push part connected with the hollow inner shaft do not twist along with the push guide wire 2; further, due to the friction between the hollow inner shaft 3, the restraining flap 4 and the blood flow guiding stent 10, the natural twisting of the blood flow guiding stent 10 during pushing is limited.

In one possible embodiment of the present delivery system, shown in fig. 5, between said hollow inner shaft 3 and the hollow inner shaft distal inner shaft fixation point 7, a central inner shaft fixation point 14 of the hollow inner shaft 3 and a second hollow inner shaft 13 similar to the hollow inner shaft 2 are mounted; further, the middle inner shaft fixing point 14 is fixed with the push guide wire 2; furthermore, the push guide wire 2 is not connected with a second hollow inner shaft 13, and can generate certain relative movement, and the movable area of the second hollow inner shaft 13 on the push guide wire 2 is limited by a middle inner shaft fixing point 14 and a far inner shaft fixing point 7; further, a convex part 12 is fixed on the second hollow inner shaft 13, when the device is in a delivery configuration, the binding flap 4 and the guide bracket 10 are both in a pressing and holding state, the convex part 12 further clings the guide bracket 10 to the inner wall of the outer sheath tube 1, so that a larger friction force is generated between the guide bracket 10 and the outer sheath tube 1, and the friction force can be used as a pushing force for pushing the guide bracket 10 forwards, so that the delivery efficiency is higher compared with the embodiment shown in fig. 1 which only pushes by the pushing force of the outer part of the hollow inner shaft close to the inner shaft fixing point 6; further, the second hollow inner shaft 13 does not twist along with the push guide wire 2 in the pushing process, and the convex part 12 does not transmit torque to the guide support 10, so that the guide support 10 is prevented from twisting in the pushing process; further, a third developing element 15 and a fourth developing element 16 are fixed at two ends of the second hollow inner shaft 13, so that the positions of the second hollow inner shaft can be observed conveniently in the operation process.

Furthermore, the conveying system has no influence on the appearance shape and the size of the device, and can be operated and used under the prior technical means.

Furthermore, the forming process and the performance of the conveying system are easy to control and guarantee.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

The relative arrangement of the components and steps, the numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present application unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

In the description of the present application, it is to be understood that the orientation or positional relationship indicated by the directional terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal" and "top, bottom", etc., are generally based on the orientation or positional relationship shown in the drawings, and are used for convenience of description and simplicity of description only, and in the case of not making a reverse description, these directional terms do not indicate and imply that the device or element being referred to must have a particular orientation or be constructed and operated in a particular orientation, and therefore, should not be considered as limiting the scope of the present application; the terms "inner and outer" refer to the inner and outer relative to the profile of the respective component itself.

Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and the terms have no special meanings unless otherwise stated, and therefore, the scope of protection of the present application is not to be construed as being limited.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.