CN216855488U - Bending balloon and interventional catheter - Google Patents

Abstract

The application provides a crooked sacculus and intervenes pipe relates to medical instrument technical field. The bending balloon comprises: a main body and a reinforcement body. The body has a length direction along a direction of fluid movement therein, and a circumferential direction around the direction of fluid movement. The reinforcing layer is arranged on the outer wall of the main body, the thickness of the reinforcing layer is 0.01-0.1 mm, the length of the reinforcing layer extending along the length direction is 1/12-1/2 of the length of the main body extending along the length direction, and the length of the reinforcing layer extending along the circumferential direction is 1/6-1/2 of the circumferential length of the main body along the circumferential direction. In the balloon of the present application, after inflation under pressure, the amount of deformation of the main body on the side where the reinforcing layer is provided is smaller than the amount of deformation of the main body on the side where the reinforcing layer is not provided, so that the balloon is bent. To the blood vessel department of corner, especially the narrow department of blood vessel, the crooked sacculus of this application can better laminating blood vessel walk the shape to reduce the risk of tearing of blood vessel inner wall.

Description

Bending balloon and interventional catheter

Technical Field

The application relates to the technical field of medical equipment, in particular to a bending balloon and an interventional catheter.

Background

Interventional therapy is a new minimally invasive treatment method for exposing focus without operation between traditional surgical and internal medical treatment, and is a method for treating local disease focus by using special instruments under the guidance of dynamic images (angiography, CT, MR, B-ultrasound) through minimally invasive holes on skin or through original channels of human bodies including blood vessels, intestines and the like by utilizing respiratory and excretory orifices of the human bodies.

Over 30 years, different interventional treatment methods have been developed, and most typically, a balloon dilatation catheter is used to assist in placement of a stent, administration of a local lesion in a blood vessel, and the like.

However, the common balloon in the blood vessel may cause the inner wall of the blood vessel to be torn, thereby generating the risk of increasing the hyperplasia of the inner wall of the blood vessel and increasing the restenosis probability of the blood vessel after operation.

SUMMERY OF THE UTILITY MODEL

It is an object of embodiments of the present application to provide a bending balloon which is able to reduce the risk of tearing of the inner wall of a blood vessel.

In a first aspect, embodiments of the present application provide a bending balloon, comprising: a main body and a reinforcement body.

The body has a length direction along a direction in which the fluid moves, and a circumferential direction around the direction in which the fluid moves.

The reinforcing layer is arranged on the outer wall of the main body, the thickness of the reinforcing layer is 0.01-0.1 mm, the length of the reinforcing layer extending along the length direction is 1/12-1/2 of the length of the main body extending along the length direction, and the length of the reinforcing layer extending along the circumferential direction is 1/6-1/2 of the circumferential length of the main body along the circumferential direction.

In the above implementation, after the balloon of the present application is inflated under pressure, the amount of deformation of the main body on the side where the reinforcing layer is provided is smaller than the amount of deformation of the main body on the side where the reinforcing layer is not provided, so that the balloon is bent. To the vascular department of corner, especially the narrow department of blood vessel, the crooked sacculus of this application can better laminating blood vessel walk the shape to reduce the tearing risk of blood vessel inner wall.

In addition, the bending balloon can be designed to form a bending shape during expansion, and external mechanical force is not required to be applied.

In one possible embodiment, the reinforcing layer is provided at a middle portion of the main body in the length direction.

In the implementation process, the reinforcing layer is arranged in the middle of the main body along the length direction, so that the C-shaped bending balloon can be obtained, and the C-shaped bending balloon is suitable for a narrow part of a blood vessel with a single corner and a corner angle of 120-150 degrees.

In one possible embodiment, the reinforcing layer extends in the longitudinal direction by 1/10 to 1/2 of the length of the main body extending in the longitudinal direction.

In the implementation process, in order to control the bending shape of the balloon after being inflated by pressure, the length of the reinforcing layer extending along the length direction is 1/10-1/2 of the length of the main body extending along the length direction.

In a possible embodiment, the reinforcing layer comprises a plurality of reinforcing strips, the plurality of reinforcing strips are sequentially arranged at intervals along the length direction, and the distance between every two adjacent reinforcing strips is 5-10 mm.

In one possible embodiment, the bending balloon comprises two reinforcing layers, and the centers of the two reinforcing layers are located at 1/8-3/8 and 5/8-7/8 in the length direction of the main body respectively.

In the implementation process, reinforcing layers are respectively arranged at 1/8-3/8 and 5/8-7/8 of the main body along the length direction, so that an S-shaped bending balloon can be obtained, and the S-shaped bending balloon is suitable for vascular lesions with two bending angles of 90-135 degrees in a short range.

In one possible embodiment, the reinforcing layer extends in the longitudinal direction by 1/12 to 1/4 of the length of the main body extending in the longitudinal direction.

In the implementation process, in order to control the bending shape of the balloon after being inflated by pressure, the length of the reinforcing layer extending along the length direction is 1/12-1/4 of the length of the main body extending along the length direction.

In a possible embodiment, the center of the two reinforcing layers forms an angle of 15-180 DEG with a line connecting the axes.

In the implementation process, in order to control the bending shape of the balloon after being inflated, the included angle between the centers of the two reinforcing layers and the connecting line of the axis is 15-180 degrees.

In one possible embodiment, the reinforcing layer is woven from metal wires, inorganic fibers or polymer fibers.

In one possible embodiment, the body extends lengthwise for a length of at least 40mm, and the body has a circumference of 4 π to 24 π mm in the circumferential direction.

In a second aspect, an interventional catheter is provided in an embodiment of the present application, which includes a tube body and the above-mentioned bending balloon, wherein the bending balloon is disposed at a distal end of the tube body.

In the above-mentioned realization process, the intervention pipe of this application is when carrying out intervention treatment, and the laminating blood vessel that crooked sacculus can be better is walked the shape to reduce the tearing risk of blood vessel inner wall.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

FIG. 1 is a schematic view of a first C-bend balloon of an embodiment of the present disclosure prior to bending;

FIG. 2 is a schematic view of a first C-bend balloon of an embodiment of the present disclosure after bending;

FIG. 3 is a schematic view of a second C-bend balloon of an embodiment of the present application before bending;

FIG. 4 is a schematic view of a third C-bend balloon of an embodiment of the present application before bending;

FIG. 5 is a schematic diagram of an S-bend balloon of an embodiment of the present application before bending;

FIG. 6 is a schematic view of the S-bend balloon of an embodiment of the present application after bending;

fig. 7 is a schematic structural diagram of an interventional catheter according to an embodiment of the present application.

Icon: 10-bending the balloon; 100-a body; 101-length direction; 102-circumferential direction; 200-a reinforcing layer; 210-a reinforcing strip; 20-an interventional catheter; 300-a tube body.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present application.

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, it need not be further defined and explained in subsequent figures.

In the description of the present application, it should be noted that the terms "center", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships that are conventionally placed when products of the application are used, and are only used for convenience in describing the application and simplifying the description, but do not indicate or imply that the devices or elements to be referred must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the application.

In the description of the present application, it is also to be noted that, unless otherwise explicitly specified or limited, the terms "disposed" and "connected" are to be interpreted broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; either mechanically or electrically. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

Referring to fig. 1 and 2, the present embodiment provides a bending balloon 10 including a main body 100 and a reinforcing layer 200.

The body 100 has a length direction 101 along a direction of fluid movement therein, and a circumferential direction 102 around the direction of fluid movement.

Note that, since the bending balloon 10 is to be inserted into a blood vessel, the shape of the main body 100 is substantially cylindrical, and the longitudinal direction 101 of the main body 100 is the axial direction of the main body 100.

The reinforcing layer 200 is disposed on the outer wall of the main body 100, the reinforcing layer 200 extends in the longitudinal direction 101 to a length 1/12-1/2 of the length of the main body 100 extending in the longitudinal direction 101, and the reinforcing layer 200 extends in the circumferential direction 102 to a length 1/6-1/2 of the circumferential length of the main body 100 extending in the circumferential direction 102.

In the balloon of the present application, after being inflated with pressure, the amount of deformation of the main body 100 on the side where the reinforcing layer 200 is provided is smaller than that of the main body 100 on the side where the reinforcing layer 200 is not provided, so that the balloon is bent. For the blood vessel of corner department, especially the narrow department of blood vessel, the crooked sacculus 10 of this application can better laminating blood vessel shape of walking to reduce the tearing risk of blood vessel inner wall.

In addition, the curved balloon 10 of the present application can be designed to form a curved shape during inflation without the application of external mechanical force. Compared with the balloon which can be deformed only by applying external mechanical force, the balloon which is passively bent eliminates balloon damage which can occur when external mechanical force is applied, and avoids the phenomenon that the balloon cannot perform the function of expansion after being pressurized. The properties of the curved balloon 10 itself and the bending properties thereof can be determined after molding, and even if it is curved after inflation, the pressure resistance thereof and the like are not responded.

Meanwhile, the bending mode of the bending balloon 10 is simple, a balloon with a complex bending shape and a special bending degree can be formed, and the balloon is inflated and expanded, namely bent. And the bending requirement can be met within the range of the target pressure value without subsequent bending adjustment or early bending adjustment, thereby saving the operation time of doctors, reducing the risk of patients and lowering the operation cost.

In the embodiment shown in fig. 1 and 2, the reinforcing layer 200 extends in the circumferential direction 102 a length 1/4 of the circumference of the main body 100 in the circumferential direction 102. In other embodiments of the present application, the reinforcing layer 200 extends in the circumferential direction 102 for a length 1/6, 1/5, 1/3, or 1/2 of the circumference of the main body 100 in the circumferential direction 102.

The body 100 extends in a length direction 101 for a length of at least 40mm, and the body 100 has a circumference of 4 pi to 24 pi mm in a circumferential direction 102.

Optionally, the length of the main body 100 extending along the length direction 101 is 40-300 mm.

The single-side wall thickness of the main body 100 is 0.01-0.1 mm.

In the embodiment shown in fig. 1 and 2, the body 100 extends in a length direction 101 of 100mm, and the body 100 has a circumference 102 of 15 mm in a circumferential direction. In some other embodiments of the present application, the length of the theme extending in the length direction 101 may also be 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 120mm, 150mm, 180mm, 200mm, 230mm, 250mm, 270mm, or 300mm, 4 pi mm, 5 pi mm, 6 pi mm, 7 pi mm, 8 pi mm, 9 pi mm, 10 pi mm, 12 pi mm, 14 pi mm, 16 pi mm, 18 pi mm, 20 pi mm, 22 pi mm, or 24 pi mm of the perimeter of the body 100 in the circumferential direction 102.

The thickness of the reinforcing layer 200 is 0.01 to 0.1 mm.

In the embodiment shown in fig. 1 and 2, the reinforcing layer 200 has a thickness of 0.05 mm. In other embodiments of the present application, the thickness of the reinforcing layer 200 may also be 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, or 0.1 mm.

The reinforcing layer 200 may be an integrally formed laminate structure or may be woven from fibers.

Alternatively, the reinforcing layer 200 is woven from metal wires, inorganic fibers, or polymer fibers.

Wherein the metal wire is a tungsten wire, a stainless steel wire, a molybdenum wire, a nickel-cobalt alloy wire, a titanium alloy wire or a nickel-titanium alloy wire; the inorganic fiber is ceramic fiber, carbon fiber or glass fiber; the polymer fiber is Poly-p-Phenylene Benzobisoxazole (PBO) fiber, polyester (Polyethylene terephthalate) fiber, nylon fiber, Polyphenylene sulfide (PPS) fiber or polyether ether ketone (PEEK) fiber.

Optionally, the reinforcing layer 200 is woven from Vectran fibers, Technora fibers, Dacron fibers, Compet fibers, Spectra fibers, Kevlar fibers, Conex fibers, Dyneema fibers, or Twaron fibers.

Optionally, the shape formed by weaving is cross-shaped, and an included angle formed between two bundles of fibers is 45-90 °.

Optionally, the reinforcement layer 200 is rectangular or square.

The reinforcing layer 200 may be a unitary structure or may be formed by combining a plurality of reinforcing strips 210.

When the reinforcing layer 200 is of an integrally molded structure, the reinforcing layer 200 is attached to a predetermined position by means of bonding or welding after the main body 100 is molded.

When the reinforcing layer 200 is formed by combining a plurality of reinforcing strips 210, after the main body 100 is molded, the arrangement direction of the plurality of reinforcing strips 210 needs to be determined, and the plurality of reinforcing strips 210 may be arranged at intervals along the length direction 101 of the main body 100 or along the circumferential direction 102 of the main body 100, and then the plurality of reinforcing strips 210 are sequentially connected to a predetermined position by means of bonding or welding.

For example, as shown in fig. 3, when the plurality of reinforcing strips 210 are arranged at intervals along the circumferential direction 102, the arrangement does not affect the curved shape of the balloon after molding;

as shown in fig. 4, when the plurality of reinforcing bars 210 are arranged at intervals along the longitudinal direction 101, the arrangement may affect the curved shape of the balloon after molding. And under the condition that the reinforcing layer 200 is the same and large in area, the larger the spacing distance of the reinforcing strips 210 is, the smaller the curvature of the balloon is; the greater the number of reinforcing strips 210, the greater the curvature of the balloon.

Optionally, the distance between two adjacent reinforcing bars 210 is 5-10 mm.

In the embodiment shown in fig. 3 and 4, the spacing between any two adjacent reinforcing bars 210 is 8 mm. In other embodiments of the present application, the distance between any two adjacent reinforcing bars 210 is 5mm, 6mm, 7mm, 9mm or 10 mm.

Alternatively, when a plurality of reinforcing bars 210 are arranged at intervals in the longitudinal direction 101, the length of each reinforcing bar 210 in the circumferential direction 102 is equal; when a plurality of reinforcing strips 210 are arranged at intervals in the circumferential direction 102, the length of each reinforcing strip 210 in the longitudinal direction 101 is equal.

With continued reference to fig. 1 and 2, the present embodiment provides a C-bend balloon 10, wherein the C-bend balloon 10 includes a reinforcing layer 200, and the reinforcing layer 200 is disposed at a middle portion of the main body 100 along the length direction 101.

For a narrow part of a blood vessel with a single corner and a corner angle of 120-150 degrees, if a common high-pressure balloon is adopted, the inner wall of the blood vessel can be torn, so that the risk of hyperplasia of the inner wall of the blood vessel is increased, and the restenosis probability of the blood vessel after operation is increased. If the C-shaped bending balloon 10 is adopted, the C-shaped bending balloon 10 can be well attached to the blood vessel to be deformed during expansion, so that the tearing risk of the inner wall of the blood vessel is reduced.

Optionally, the reinforcing layer 200 is centered at 1/4-3/4 of the main body 100 along the length direction 101.

In the embodiment shown in fig. 1 and 2, the reinforcing layer 200 is centered at 1/2 along the length direction 101 of the main body 100. In other embodiments of the present application, the reinforcing layer 200 is centered at 1/4 or 3/4 of the main body 100 along the length direction 101.

It should be noted that the center position of the reinforcing layer 200 determines the bending position of the balloon, and the center position of the reinforcing layer 200 can be selected according to specific requirements.

The reinforcing layer 200 extends in the longitudinal direction 101 to a length 1/10-1/2 of the length of the main body 100 extending in the longitudinal direction 101.

In the embodiment shown in fig. 1 and 2, the reinforcing layer 200 extends in the longitudinal direction 101 a length 1/5 which is the length of the main body 100 extending in the longitudinal direction 101. In other embodiments of the present application, the reinforcing layer 200 extends along the length direction 101 for a length 1/10, 1/9, 1/8, 1/7, 1/6, 1/4, 1/3, or 1/2 of the length that the main body 100 extends along the length direction 101.

It should be noted that the length of the reinforcing layer 200 extending along the longitudinal direction 101 determines the bending degree of the balloon, and the length of the reinforcing layer 200 extending along the longitudinal direction 101 may be selected according to specific requirements.

Referring to fig. 5 and 6, the present embodiment provides an S-bend balloon 10, in which the bend balloon 10 includes two reinforcing layers 200, and the centers of the two reinforcing layers 200 are located at 1/8-3/8 and 5/8-7/8 of the main body 100 along the length direction 101.

For a vascular lesion with two bends with a bending angle of 90-135 degrees in a short range, if a common high-pressure balloon is used for treatment, the inner wall of a blood vessel can be torn, so that the risk of hyperplasia of the inner wall of the blood vessel is increased, and the restenosis probability of the blood vessel after operation is increased. If the S-shaped bending balloon 10 is adopted, the S-shaped bending balloon 10 can be well attached to the blood vessel to be deformed during expansion, so that the tearing risk of the inner wall of the blood vessel is reduced.

In the embodiment shown in fig. 5 and 6, the centers of the two reinforcing layers 200 are located at 2/8 and 6/8 of the main body 100 in the length direction 101, respectively. In other embodiments of the present application, the two reinforcement layers 200 are centered at 1/8 and 7/8 along the length direction 101, or 3/8 and 5/8 along the length direction 101, or 1/8 and 5/8 along the length direction 101, or 3/8 and 7/8 along the length direction 101 of the main body 100, respectively.

The reinforcing layer 200 extends in the longitudinal direction 101 to a length 1/12-1/4 of the length of the main body 100 extending in the longitudinal direction 101.

In the embodiment shown in fig. 5 and 6, the reinforcing layer 200 extends in the longitudinal direction 101 for a length 1/8 that is equal to the length that the main body 100 extends in the longitudinal direction 101. In other embodiments of the present application, the reinforcing layer 200 extends along the length direction 101 for a length 1/12, 1/11, 1/10, 1/9, 1/7, 1/6, 1/5, or 1/4 of the length that the main body 100 extends along the length direction 101.

The included angle between the connecting line of the centers of the two reinforcing layers 200 and the axis is 15-180 degrees.

In the embodiment shown in fig. 5 and 6, the centers of the two reinforcing layers 200 are at an angle of 180 ° to the line connecting the axes. In other embodiments of the present application, the angle between the center of the two reinforcement layers 200 and the line connecting the axes is 15 °, 20 °, 30 °, 45 °, 60 °, 70 °, 85 °, 90 °, 100 °, 120 °, 135 °, 150 °, 160 °, or 170 °.

It should be noted that the length of the two reinforcing layers 200 extending along the length direction 101, the central position of the two reinforcing layers 200, and the included angle between the center of the two reinforcing layers 200 and the line of the axis may determine the bending position and the bending degree of the balloon, and the length of the two reinforcing layers 200 extending along the length direction 101, the central position of the two reinforcing layers 200, and the included angle between the center of the two reinforcing layers 200 and the line of the axis may be selected according to specific requirements.

For example, the two reinforcing layers 200 extend in the longitudinal direction 101 to the same length, the center positions of the two reinforcing layers 200 are symmetrical, and the included angle between the center of the two reinforcing layers 200 and the line connecting the axes is 180 °, so that a symmetrically curved balloon can be obtained.

The angle between the center of the two reinforcing layers 200 and the line connecting the axes is changed to 45 degrees, 90 degrees or 135 degrees, and the other angles are not changed, so that the balloon with asymmetric bending can be obtained.

Referring to fig. 7, the present embodiment further provides an interventional catheter 20, which includes a tube 300 and the bending balloon 10, wherein the bending balloon 10 is disposed at a distal end of the tube 300.

When the interventional catheter 20 is used for interventional therapy, the curved balloon 10 can better adhere to a blood vessel to form a walk, so that the tearing risk of the inner wall of the blood vessel is reduced.

In summary, in the balloon of the present application, after the balloon is inflated by pressure, the amount of deformation of the main body 100 on the side where the reinforcing layer 200 is provided is smaller than the amount of deformation of the main body 100 on the side where the reinforcing layer 200 is not provided, so that the balloon is bent. For the blood vessel of corner department, especially the narrow department of blood vessel, the crooked sacculus 10 of this application can better laminating blood vessel shape of walking to reduce the tearing risk of blood vessel inner wall. In addition, the curved balloon 10 of the present application can be designed to form a curved shape during inflation without the application of external mechanical force. Compared with the balloon which can be deformed only by applying external mechanical force, the balloon which is passively bent eliminates balloon damage which can occur when external mechanical force is applied, and avoids the phenomenon that the balloon cannot perform the function of expansion after being pressurized. The properties of the curved balloon 10 itself and the bending properties thereof can be determined after molding, and even if it is curved after inflation, the pressure resistance thereof and the like are not responded. Meanwhile, the bending mode of the bending balloon 10 is simple, a balloon with a complex bending shape and a special bending degree can be formed, and the balloon is inflated and expanded, namely bent. And the bending requirement can be met within the range of the target pressure value without subsequent bending adjustment or early bending adjustment, thereby saving the operation time of doctors, reducing the risk of patients and lowering the operation cost.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims (10)

1. A bending balloon, comprising:

a body having a length direction along a direction of fluid movement therein, and a circumferential direction around the direction of fluid movement;

the reinforcing layer, the reinforcing layer set up in the outer wall of main part, the thickness of reinforcing layer is 0.01 ~ 0.1mm, just the reinforcing layer is followed length direction extension's length is the main part is followed length direction extension's length 1/12 ~ 1/2, the reinforcing layer is followed length direction extension's length is the main part is followed 1/6 ~ 1/2 of circumference.

2. The bending balloon of claim 1, wherein the reinforcing layer is disposed in a middle portion of the main body in the length direction.

3. The curved balloon of claim 2, wherein the reinforcing layer extends along the length of 1/10-1/2 of the length of the main body along the length.

4. The bending balloon according to claim 2, wherein the reinforcing layer comprises a plurality of reinforcing strips, the plurality of reinforcing strips are sequentially arranged at intervals along the length direction, and the distance between every two adjacent reinforcing strips is 5-10 mm.

5. The bending balloon of claim 1, comprising two of the reinforcing layers, the reinforcing layers centered at 1/8-3/8 and 5/8-7/8, respectively, of the main body along the length direction.

6. The curved balloon of claim 5, wherein the reinforcing layer extends along the length of 1/12-1/4 of the length of the main body along the length.

7. The bending balloon according to claim 5, wherein the angle between the centers of the two reinforcing layers and the line connecting the axes is 15-180 °.

8. The curved balloon of claim 1, wherein the reinforcing layer is woven from metal wires, inorganic fibers, or polymeric fibers.

9. The curved balloon of claim 1, wherein the body extends in the length direction for a length of at least 40mm, and the body has a circumference of between 4 pi and 24 pi mm in the circumferential direction.

10. An interventional catheter, comprising a tube and a bending balloon according to any one of claims 1 to 9, the bending balloon being disposed at a distal end of the tube.

Images