CN115068165A - Skeleton, skeleton manufacturing method and blood vessel far-end protection device - Google Patents

Abstract

The utility model provides a skeleton for blood vessel distal end protection device, includes skeleton pole (1), string bag mouth (2), and string bag mouth (2) set up on skeleton pole (1), and skeleton pole (1) and string bag mouth (2) are integrated into one piece, and string bag mouth (2) are equipped with two fixed points on the skeleton pole, first fixed point (21) and second fixed point (22), are equipped with the distance between two points. The utility model provides a blood vessel distal end protection device, includes skeleton (4) and string bag (5), and skeleton (4) are foretell skeleton, and string bag (5) are the toper string bag, and the string bag opening is fixed on string bag mouth (2) of skeleton. The invention adopts the staggered skeleton to reduce the outline; the taper transition type is adopted at the initial section of the recovery stage, so that the gradual guidance recovery is facilitated when the sleeve is entered, the use resistance of the instrument is reduced, and the risk of product separation is reduced.

Description

Skeleton and skeleton fabrication method and vascular distal protection device

technical field

The present invention relates to a medical device, in particular to a blood vessel protection device.

Background technique

At present, most of the self-expanding vascular protection devices on the market use a nickel-titanium tube to cut the skeleton and then cover it to form a mesh pocket to protect the blood vessels. Large and difficult, and insufficient adherence to the circumferential direction of the blood vessel.

SUMMARY OF THE INVENTION

One of the objectives of the present invention is to provide a skeleton that reduces the profile of the product, reduces the resistance during ejection and recovery, and improves the adherence performance of the product.

One of the objectives of the present invention is to provide a skeleton manufacturing method that reduces the profile of the product, reduces the resistance during push out and recovery, and improves the wall-adhering performance of the product.

One of the objectives of the present invention is to provide a distal vessel protection device that reduces the profile of the product, reduces the resistance during push-out and retraction, and improves the adherence performance of the product.

One of the objectives of the present invention can be achieved by designing a skeleton for a distal blood vessel protection device, including a skeleton rod and a net pocket. The skeleton rod is in the shape of a straight rod. There are two fixed points on it, a first fixed point and a second fixed point, and a distance is set between the two points.

Preferably, the skeleton rod and the net pocket mouth are integrally formed, the distance between the fixed points of the net pocket mouth on the skeleton rod is greater than 0 but less than or equal to 1.0 times the diameter of the net pocket mouth, and the highest point of the net pocket mouth is vertically projected on the projection point on the skeleton rod The distance from the first fixed point is greater than 0 and less than or equal to 1.7 times the diameter of the net pocket.

Preferably, several net pocket hooks or net pocket hanging holes are arranged on the frame rod and the net pocket mouth.

Preferably, the net pocket hooks or net pocket hanging holes are arranged at the first fixing point, the second fixing point, the highest point, the two side points and at least one far point on the frame rod of the net pocket opening.

Preferably, several hollow sections are arranged on the skeleton rod.

Preferably, the material employed is a metallic material with self-expansion, including memory nickel-titanium alloys.

One of the objects of the present invention can be achieved in this way, and a method for making a skeleton is designed, including:

A. Select pipes with self-expanding metal materials;

B. Design the skeleton rod along the length direction on the pipe;

C. Select the first fixed point of the mesh pocket on the designed skeleton rod, and select the second fixed point of the mesh pocket at the position where the distance from the first fixed point is greater than 0 but less than or equal to 1.0 times the diameter of the pipe. The distance between the projection point and the first fixed point is greater than 0 but less than or equal to 1.7 times the diameter of the net pocket, and the highest point of the net pocket is selected, and the three points are connected to form the net pocket mouth;

D. The skeleton is obtained by laser cutting.

Preferably, a net pocket hanging position is set on the net pocket opening and the framework rod of the skeleton, and a net pocket hook or Holes for net pockets.

One of the objectives of the present invention can be achieved by designing a device for protecting a distal end of a blood vessel, including a skeleton and a net pocket, the skeleton is the aforementioned skeleton, the net pocket is a tapered net pocket, and the opening of the net pocket is fixed on the net pocket of the skeleton.

Preferably, the net pocket is a net pocket made of memory nickel-titanium alloy or a nylon net pocket or a PET net pocket or a PE net pocket or a PTFE net pocket or a PP net pocket, and the mesh diameter of the net pocket is 70-200um.

The overall product of the present invention has a smaller profile due to the dislocation and alignment of the skeleton. The taper transition type is adopted in the initial section of the recovery stage, which facilitates the gradual and guided recovery when entering the sleeve, thereby reducing the resistance to use of the device and the risk of product detachment. Because of the dislocation design, different soft nickel-titanium materials are used to make it better adhere to the wall.

Description of drawings

Fig. 1 is the schematic diagram of one of the preferred embodiments of the skeleton of the present invention;

Fig. 2 is the schematic diagram of the second preferred embodiment of the skeleton of the present invention;

Fig. 3 is the schematic diagram of the third preferred embodiment of the skeleton of the present invention;

4 is another perspective view of the second preferred embodiment of the skeleton of the present invention;

5 is another perspective view of the second preferred embodiment of the skeleton of the present invention;

Fig. 6 is the schematic diagram of the skeleton cutting of the present invention;

Fig. 7 is the schematic diagram after the skeleton of the present invention is cut;

8 is a schematic diagram of one of the preferred embodiments of the vessel distal protection device of the present invention;

9 is a schematic diagram of the second preferred embodiment of the vessel distal protection device of the present invention;

10 is a schematic diagram of the third preferred embodiment of the vessel distal protection device of the present invention;

11 is a schematic diagram of the application of the distal vessel protection device of the present invention;

FIG. 12 is a partial enlarged view of FIG. 11 .

Detailed ways

The present invention will be further described below in conjunction with the embodiments.

As shown in Fig. 1, Fig. 2, Fig. 3, Fig. 4, a skeleton is used for a distal vascular protection device, comprising a skeleton rod 1, a net pocket 2, and the net pocket 2 is fixed on the skeleton rod 1, and the net pocket 2 There are two fixed points on the skeleton rod, a first fixed point 21 and a second fixed point 22, and a distance is set between the two points.

As shown in Figure 1, Figure 2 and Figure 3, the minimum distance between the fixed points of the net pocket on the skeleton rod is greater than 0 and the maximum distance is less than or equal to 1.0 times the diameter of the net pocket. The vertical projection of the highest point 23 of the net pocket on the skeleton The minimum distance between the projection point on the rod and the first fixed point 21 is greater than 0 and the maximum distance is less than or equal to 1.7 times the diameter of the net pocket. The highest point 23 of the net pocket is the maximum vertical distance point on the net pocket relative to the frame rod 1 .

The skeleton is cut from the entire nickel-titanium tube, and the diameter of the net pocket is the diameter of the nickel-titanium tube. As shown in Figure 5, the product as a whole is a very regular circle when viewed along the axis of the skeleton rod 1. The distance between the first fixed point and the second fixed point is 0.05 to 2.99 mm when the pipe diameter is 3 mm, 0.1 to 3.99 mm when the pipe diameter is 4 mm, and 0.3 to 4.99 mm when the pipe diameter is 5 mm. When it is 6 mm, it is 0.5 to 5.99 mm, when the pipe diameter is 7 mm, it is 0.8 to 6.99 mm, and when the pipe diameter is 8 mm, it is 1 to 7.99 mm.

The skeleton adopts a dislocation skeleton structure. The whole structure is cut from the entire nickel-titanium tube. The five points of the net pocket are not on the same plane. The first fixed point 21, the second fixed point 22, the highest point 23, the front side point 24, The rear side points 25 are spaced apart, so that when the sleeve is retracted, the overlapping parts of the skeleton become less, thereby reducing the overall profile of the product and reducing the frictional force of retracting and pushing out the sleeve.

As shown in Figure 5, the whole product is a very regular circle when viewed along the axial direction of the skeleton rod 1, which is beneficial to fit the blood vessel wall.

As shown in FIG. 6 and FIG. 7 , several net pocket hooks 3 or net pocket hanging holes are arranged on the frame rod 1 and the net pocket opening 2 . The net pocket hook 3 or the net pocket hanging hole is used to fix the net pocket 5 .

As shown in Fig. 6 and Fig. 7 , a net pocket hanging position is set on the net pocket opening and the skeleton rod of the skeleton, and the net pocket hook 3 or net pocket hanging hole are respectively arranged at the first fixing point 21, the second fixing point 22, the highest point of the net pocket mouth. 23. At least one far point on the two side points (front side point 24, rear side point 25) and on the skeleton rod 1. In this embodiment, the net pocket hook 3 or the net pocket hanging hole on the frame rod 1 is arranged at a point on the rear side of the frame rod 1 . As shown in Figure 1, a far-point net pocket hook or net pocket hanging hole can be set on the skeleton rod. As shown in Figure 2 and Figure 3, two or three remote net pocket hooks or net pocket hanging holes can be set on the skeleton rod. .

As shown in FIG. 3 and FIG. 9 , a plurality of hollow sections 11 are arranged on the skeleton rod 1 . A hollow structure is adopted in the middle part of the skeleton rod 1, which can increase the passability and bending resistance of the skeleton at the diseased part.

The material used for the skeleton is a metal material with self-expansion, including memory nickel-titanium alloy. By using such material, the skeleton can be deformed due to the external force, and it can return to its original state after the external force is removed, and the opening of the net pocket 5 can be opened by opening the net pocket.

A method for making a skeleton, comprising:

A. Select pipes with self-expanding metal materials;

B. Design the skeleton rod along the length direction on the pipe;

C. Select the first fixed point of the net pocket on the designed skeleton rod, and select the second fixed point of the net pocket between the positions where the distance from the first fixed point is greater than 0 but less than or equal to 1.0 times the diameter of the pipe. Select the highest point of the net pocket at the position where the distance between the projection point and the first fixed point is greater than 0 but less than or equal to 1.7 times the diameter of the pipe, and connect the three points on the pipe to form the net pocket; Net pocket hooks or net pocket hanging holes are arranged at the fixed point, the highest point, the two side points and at least one far point on the skeleton rod. The distance between the first fixed point and the second fixed point is 0.05 to 2.99 mm when the pipe diameter is 3 mm, 0.1 to 3.99 mm when the pipe diameter is 4 mm, and 0.3 to 4.99 mm when the pipe diameter is 5 mm. When the diameter is 6mm, it is 0.5 to 5.99mm, when the diameter is 7mm, it is 0.8 to 6.99mm, and when the diameter is 8mm, it is 1 to 7.99mm. As shown in Figure 1, a far-point net pocket hook or net pocket hanging hole can be set on the skeleton rod. As shown in Figure 2 and Figure 3, two or three remote net pocket hooks or net pocket hanging holes can be set on the skeleton rod. .

D. According to the above design, the skeleton is obtained by laser cutting, as shown in Figure 6 and Figure 7.

As shown in Figure 6 and Figure 7, the entire structure is cut from the entire nickel-titanium tube, and the five points on the net pocket 2 (the first fixed point 21, the second fixed point 22, the highest point 23, and the points on both sides are the front The side point 24 and the rear side point 25) are not in the same plane. Fig. 6 also shows the remaining waste except the skeleton, and the skeleton shown in Fig. 7 is obtained after cutting the remaining waste.

As shown in Fig. 8, Fig. 9, Fig. 10, a blood vessel distal protection device comprises a skeleton 4 and a net pocket 5, the skeleton 4 is the skeleton described above, the net pocket 5 is a tapered net pocket, and the opening of the net pocket 5 is fixed on the skeleton on the net pocket 2. The opening of the net pocket 5 is fixed on the net pocket hook 3 or the net pocket hanging hole of the net pocket 2 , and the middle or tail of the net pocket 5 is fixed on the net pocket hook 3 or the net pocket hanging hole provided on the frame rod 1 .

The net pocket 5 is a net pocket made of memory-type nickel-titanium alloy, or a nylon net pocket, or a PET net pocket. The mesh hole diameter of the net pocket 5 is 70-200um. In one embodiment, the mesh hole diameter of the net pocket 5 is 70um. The mesh diameter is 90um in one embodiment, 100um in one embodiment, 120um in one embodiment, 150um in one embodiment, and 200um in one embodiment. The net pocket made of memory nickel-titanium alloy can be restored to its original state by itself; using nylon net pocket or PET net pocket or PE net pocket or PTFE net pocket or PP net pocket, the net pocket 5 is opened by the self-recovery of the net pocket 2. The selection of the material of the mesh pocket 5 and the diameter of the mesh holes facilitates the contraction and opening while taking into account the collection of thrombus fragments.

As shown in FIG. 11 and FIG. 12 , in the application of the distal vascular protection device of the present invention, the supporting microcatheter includes a microcatheter body 7 and a microcatheter Luer connector 8; It is used to increase the flexibility and bending resistance of the distal end; the net pocket 5 is used to salvage the broken thrombus fragments; the skeleton 4 is used to fix and release the net pocket 5; The position of the product is marked in the body; the push rod 10 is welded with the skeleton 4, and the doctor can use it to push and recover the skeleton 4.

The present invention adopts a unique skeleton structure, which utilizes skeleton dislocation to reduce the profile of the product, and at the same time adopts a taper transition type in the initial section of the recovery stage, which is convenient for gradual and directional recovery when entering the sleeve. This structure is viewed from the longitudinal direction. It is a round shape that can better fit the vessel wall 360 degrees, preventing thrombus fragments from leaking from the skeleton and the vessel wall stent to block distal vessels.

The product of the present invention can be inserted into the blood vessel percutaneously, and is placed at the distal end of the blood vessel during stent implantation, thrombus extraction, and balloon expansion to prevent its blockage, and is compatible with intracranial, cardiovascular and peripheral blood vessels.

Claims (10)

1. The utility model provides a skeleton for blood vessel distal end protection device, includes skeleton pole (1), string bag mouth (2), its characterized in that: hack lever (1) is straight rod-shaped, and net pocket mouth (2) set up on hack lever (1), and net pocket mouth (2) are equipped with two fixed points on the hack lever, first fixed point (21) and second fixed point (22), are equipped with the distance between two points.

2. The armature of claim 1, wherein: the skeleton rod (1) and the net bag opening (2) are integrally formed, the minimum distance between the fixed points of the net bag opening on the skeleton rod is larger than 0, the maximum distance is smaller than or equal to 1.0 time of the caliber of the net bag opening, and the distance between the projection point of the highest point (23) of the net bag opening on the skeleton rod and the first fixed point (21) is larger than 0 and smaller than or equal to 1.7 times of the caliber of the net bag.

3. The armature of claim 1, wherein: a plurality of net bag hooks (3) or net bag hanging holes are arranged on the skeleton rod (1) and the net bag opening (2).

4. The armature of claim 3, wherein: the net bag hook (3) or the net bag hanging hole is provided with a first fixed point (21), a second fixed point (22), a highest point (23), two side points and at least one far point on the skeleton rod (1).

5. The armature of claim 1, wherein: a plurality of hollow sections (11) are arranged on the skeleton rod (1).

6. The armature of claim 1, wherein: the adopted material is a metal material with self-expansion, including memory type nickel-titanium alloy.

7. A method of making a skeleton, comprising:

A. selecting a pipe with a self-expanding metal material;

B. designing a skeleton rod on the pipe along the length direction, wherein the skeleton rod is in a straight rod shape;

C. selecting a first fixed point of the net inlet on a designed framework rod, selecting a second fixed point of the net inlet at a position which is more than 0 and less than or equal to 1.0 time of the caliber of the pipe away from the first fixed point, selecting the highest point of the net inlet at a position which is more than 0 and less than or equal to 1.7 times of the caliber of the pipe away from a vertical projection point on the framework rod and the first fixed point, and connecting the three points to form the net inlet;

D. the skeleton is obtained by laser cutting.

8. The method of manufacturing a skeleton according to claim 7, wherein: the net bag hanging position is arranged on the net bag opening and the skeleton rod of the skeleton, and the net bag hook or the net bag hanging hole is arranged on the first fixing point, the second fixing point, the highest point and the two side points of the net bag opening and at least one far point on the skeleton rod.

9. A distal vascular protection device, comprising: comprises a framework (4) and a net bag (5), wherein the framework (4) is the framework as claimed in claims 1 to 8, the net bag (5) is a conical net bag, and the opening of the net bag (5) is fixed on the net bag opening (2) of the framework.

10. The distal vascular protection device of claim 9, wherein: the net bag (5) is a memory type nickel-titanium alloy woven net bag or a nylon net bag or a PET net bag or a PE net bag or a PTFE net bag or a PP net bag, and the diameter of the net holes of the net bag (5) is 70-200 um.

Images