CN118949242B

CN118949242B - A coated balloon, a balloon catheter and a balloon catheter assembly

Info

Publication number: CN118949242B
Application number: CN202411407011.1A
Authority: CN
Inventors: 居彬; 牛冬子; 翁玉麟
Original assignee: Dk Medical Technology Co ltd
Current assignee: Dk Medical Technology Co ltd
Priority date: 2024-10-10
Filing date: 2024-10-10
Publication date: 2025-01-24
Anticipated expiration: 2044-10-10
Also published as: CN118949242A

Abstract

The present invention relates to the field of medical device technology, and discloses a coated balloon, a balloon catheter, and a balloon catheter assembly. The coated balloon comprises: a balloon and a fiber braided layer. The fiber braided layer is coated on the outer surface of the balloon, and has a telescopic portion and a matching portion. The telescopic portion is located on a first side of the balloon, and the matching portion is located on a second side of the balloon opposite to the first side. When the balloon is inflated, the telescopic portion and the matching portion are suitable for bending in the same direction, and the extension length of the telescopic portion is greater than the extension length of the matching portion, so that the balloon bends. The coated balloon provided by the present invention has good pressure resistance and can bend and expand to adapt to the shape of curved human tortuous blood vessels. It can meet the surgical needs of tortuous blood vessel stenosis and expansion, and provides a favorable guarantee for the success of the operation.

Description

Tectorial membrane sacculus, sacculus pipe and sacculus pipe subassembly

Technical Field

The invention relates to the technical field of medical instruments, in particular to a covered balloon, a balloon catheter and a balloon catheter assembly.

Background

Balloon dilation catheters are widely used for treating vascular stenosis of a human body, and due to the difference of elasticity of different blood vessels, conventional balloons cannot adapt to all balloon dilation operation requirements, particularly when a patient blood vessel has serious calcification, the conventional balloons cannot provide sufficient dilation pressure for the calcified blood vessel, the lesion blood vessel is difficult to dilate, even the balloon is easy to puncture by the calcification, and vascular intima is injured, so that operation fails.

In order to improve the pressure resistance of the balloon, a common mode is to form a tectorial membrane balloon by tectorial membrane on the surface of the balloon, although the mode improves the structural strength of the outer surface of the balloon, the elasticity of the outer surface of the balloon is reduced, the tectorial membrane balloon is difficult to smoothly enter or pass through a human circuitous calcified blood vessel in the process of expanding the human circuitous calcified blood vessel stenosis, the requirement of expanding the human circuitous calcified blood vessel stenosis cannot be met, if the balloon forcefully enters or passes through the human circuitous calcified blood vessel, great pain can be brought to a patient, even the damage or rupture of the inner wall of the blood vessel can be caused, and the operation failure is caused.

Disclosure of Invention

In view of the above, the present invention provides a covered balloon, a balloon catheter and a balloon catheter assembly, so as to solve the problem that the conventional covered balloon cannot adapt to the requirement of the dilation operation of the human circuitous calcified vascular stenosis.

In a first aspect, the present invention provides a covered balloon comprising:

A balloon;

The fiber braid, the cladding is in the surface of sacculus, have telescopic part and cooperation portion, telescopic part is located the first side of sacculus, cooperation portion be located on the sacculus with the second side that first side is relative when the sacculus is full, telescopic part and cooperation portion are suitable for crooked to the same direction, telescopic part's extension length is greater than cooperation portion's extension length makes the sacculus takes place to crooked.

Optionally, the fiber braid includes first fibers and second fibers, a plurality of the first fibers are disposed at intervals on an outer surface of the balloon and extend in a direction parallel to an axial direction of the balloon, the second fibers are spiral and extend in a direction from a proximal end to a distal end on the outer surface of the balloon, wherein the plurality of first fibers on a first side of the outer surface of the balloon have continuously curved sections, the plurality of curved sections form the expansion portion, and the plurality of first fibers on an opposite side of the expansion portion form the mating portion.

Optionally, the second fiber is bonded to the outer surface of the balloon, the curved section is not fixed to the outer surface of the balloon, and the first fiber except for the curved section is bonded to the outer surface of the balloon.

Optionally, the first and second fibers are fiber clusters formed from a plurality of fiber bundles.

Optionally, the fiber filaments have a diameter size ranging from 0.010mm to 0.030mm and a tensile break strength of 3.0GPa to 4.0GPa.

Optionally, the fiber yarn is made of high-strength fiber compounded by one or more materials of poly-p-phenylene terephthamide fiber, aromatic polyamide copolymer fiber, heterocyclic polyamide fiber, carbon fiber, graphite fiber and silicon carbide fiber.

In a second aspect, the invention provides a balloon catheter, which comprises a catheter and the above-mentioned tectorial membrane balloon, wherein the tectorial membrane balloon is arranged at the distal end of the catheter, the balloon comprises a balloon expansion section which is positioned in the middle and is cylindrical, a balloon distal end connecting section and a balloon proximal end connecting section which are positioned at the two axial ends of the balloon expansion section and are in a truncated cone shape, and the balloon distal end connecting section and the balloon proximal end connecting section are respectively connected with the catheter.

In a third aspect, the present invention provides a balloon catheter assembly, including the balloon catheter described above, and further including a cannula, the catheter being located in an inner lumen of the cannula, a tube expanding portion being provided at a distal end of the cannula, the covered balloon being adapted to be contracted and to enter the tube expanding portion.

Optionally, a reducing portion is disposed between the expanding portion and the sleeve, and the shape and size of the inner wall of the reducing portion correspond to the shape and size of the outer wall of the proximal end of the covered balloon.

Optionally, the distal nozzle of the expanded section is provided with a chamfer.

The beneficial effects are that:

1. the invention provides a covered balloon which comprises a balloon and a fiber braiding layer. The fiber braid cladding has telescopic portion and cooperation portion at the surface of sacculus, and telescopic portion is located the first side of sacculus, and cooperation portion is located the second side relative with first side on the sacculus, and when the sacculus was full, telescopic portion and cooperation portion were suitable for crooked to the same direction, and the extension length of telescopic portion is greater than the extension length of cooperation portion, makes the sacculus takes place to crooked.

The fiber woven layer can improve the pressure resistance of the outer surface of the balloon so as to adapt to calcified vascular lesions, when the tectorial membrane balloon moves to the human body detouring blood vessel, the balloon and the fiber woven layer coated on the surface of the balloon are in a folding shrinkage state so that the tectorial membrane balloon enters the human body detouring blood vessel, after the tectorial membrane balloon moves to a lesion position, the balloon can be filled, and because the extension length of the expansion part is greater than the extension length of the matching part, the restraint forces born by the two opposite sides of the balloon are different, and along with the filling progress of the balloon, the whole balloon expands and bends and expands the human body detouring blood vessel.

Therefore, the covered saccule provided by the invention has good pressure resistance, can adapt to the shape of a bent human body detoured blood vessel to bend and expand, can adapt to the operation requirement of detoured blood vessel stenosis expansion, and provides a favorable guarantee for the success of the operation.

2. The balloon catheter assembly comprises the balloon catheter assembled with the tectorial membrane balloon, and further comprises a sleeve, wherein the catheter is positioned in an inner cavity of the sleeve, an expanding part is arranged at the distal end of the sleeve, and the tectorial membrane balloon is suitable for contracting and entering into the expanding part.

Considering that the fiber woven layer of the tectorial membrane saccule can be subjected to frictional resistance when moving in the blood vessel, the tectorial membrane saccule is received into the pipe expanding part of the sleeve, the pipe expanding part can replace the tectorial membrane saccule to be contacted with the inner wall of the blood vessel, the frictional resistance of the tectorial membrane saccule and the inner wall of the blood vessel is reduced, meanwhile, the overstretching performance of the tectorial membrane saccule can not be influenced, and the saccule catheter with the tectorial membrane saccule can be conveniently and smoothly moved in the blood vessel.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic structural view of a covered balloon according to an embodiment of the present invention;

FIG. 2 is a schematic view of the telescoping portion of the covered balloon shown in FIG. 1;

FIG. 3 is a schematic view of the mating portion of the covered balloon shown in FIG. 1;

FIG. 4 is a schematic view of the covered balloon shown in FIG. 1 in a flexed configuration;

FIG. 5 is a schematic structural view of a balloon catheter assembly according to an embodiment of the present invention;

fig. 6 is a schematic cross-sectional view of the balloon catheter assembly shown in fig. 5.

Reference numerals illustrate:

1. A balloon; 101, a balloon expansion section, 102, a balloon distal end connecting section, 103, a balloon proximal end connecting section, 11, a balloon leg, 2, a fiber braiding layer, 201, a telescopic part, 202, a matching part, 21, a first fiber, 22, a second fiber, 211, a bending section, 3, a catheter, 4, a sleeve, 41, an expanded part, 42, a reducing part, 43 and a chamfer.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application. In embodiments of the present application, "proximal" refers to the end closer to the operator and "distal" refers to the end farther from the operator.

As shown in fig. 1,2, 3 and 4, a coated balloon is provided in an embodiment of the present application comprising a balloon 1 and a woven layer of fibers 2.

The middle part of sacculus 1 is cylindricly, and the proximal end and the distal end of sacculus 1 are the toper, specifically, sacculus 1 is including being located the centre and being cylindric sacculus expansion section 101, being located the axial both ends of sacculus expansion section 101 and being balloon distal end linkage segment 102 and the sacculus proximal end linkage segment 103 of round platform form, and the distal end of sacculus distal end linkage segment 102 is connected with sacculus pipe leg 11, and the proximal end of sacculus proximal end linkage segment 103 is connected with sacculus pipe leg 11 equally, and two sacculus pipe legs 11 are connected with the pipe respectively, and sacculus expansion section 101 can be with filling liquid volume or gas volume increase and expand gradually to expand the blood vessel.

The fiber woven layer 2 is coated on the outer surface of the balloon 1, the coverage area comprises a balloon expansion section 101, a balloon distal end connecting section 102 and a balloon proximal end connecting section 103 of the balloon 1, the fiber woven layer 2 is provided with a telescopic part 201 and a matching part 202, the telescopic part 201 is positioned on the first side of the balloon 1, the matching part 202 is positioned on the second side opposite to the first side of the balloon 1, the telescopic part 201 and the matching part 202 are suitable for being bent in the same direction, the extension length of the telescopic part 201 is greater than that of the matching part 202, the balloon 1 is bent, the same direction means that the telescopic part 201 and the matching part 202 can be bent towards the same or similar angle, the whole of the coated balloon is taken as a reference, the telescopic part 202 is concave, the telescopic part 201 is convex, and the whole of the coated balloon is bent to adapt to the shape of the inner wall of a roundabout blood vessel.

The fiber woven layer 2 can be deformed adaptively under the action of external force, and is restored after the external force is withdrawn, the covered balloon is generally assembled at the distal end of the catheter, for example, as shown in fig. 1, the balloon 1 can be sleeved at the distal end of the catheter 3, a guide wire can be stretched into the catheter 3 during use, the guide wire guides the distal end of the catheter 3 to move, the balloon 1 and the fiber woven layer 2 are in a folded and contracted state before the covered balloon reaches a lesion position, after the covered balloon moves to the lesion position, the expansion force of the balloon 1 causes the expansion part 201 and the matching part 202 of the fiber woven layer 2 to deform to different degrees along with the filling progress of the balloon 1, and finally the fiber woven layer 2 restrains the balloon 1 into a curved shape. When the balloon 1 needs to be withdrawn, the balloon 1 gradually decompresses and contracts, and the fiber woven layer 2 synchronously contracts until the balloon 1 and the fiber woven layer 2 are restored to a folded and contracted state.

The fiber woven layer 2 can improve the pressure resistance of the outer surface of the balloon 1 so as to adapt to calcified vascular lesions, when the tectorial membrane balloon moves to a human body detouring blood vessel, the balloon 1 and the fiber woven layer 2 coated on the surface of the balloon 1 are in a folding shrinkage state so that the tectorial membrane balloon enters the human body detouring blood vessel, after the tectorial membrane balloon moves to a lesion position, the balloon 1 can be inflated, and as the extension length of the extension part 201 is greater than the extension length of the matching part 202, the restraint forces born by two opposite sides of the balloon 1 are different, and along with the inflation progress of the balloon 1, the whole balloon 1 expands and bends and expands the human body detouring blood vessel.

Therefore, the covered saccule provided by the application has good pressure resistance, can adapt to the shape of a bent human body detoured blood vessel to bend and expand, can adapt to the operation requirement of detoured blood vessel stenosis expansion, and provides a favorable guarantee for the success of the operation.

It should be noted that, the covered balloon provided by the application is not only suitable for calcified lesion blood vessels, but also can be applied to blood vessels with thicker blood vessel walls and smaller elasticity, and compared with the conventional balloon, the covered balloon provided by the application has enough pressure resistance. In addition, the elastic modulus of the fiber woven layer 2 is larger than that of the balloon 1, so that the fiber woven layer 2 has enough restraining force on the balloon 1, and the balloon 1 is bent under the combined action of the telescopic part 201 and the matching part 202.

As shown in fig. 2 and 3, in the present embodiment, the fiber braid 2 includes first fibers 21 and second fibers 22, the first fibers 21 are disposed at intervals on the outer surface of the balloon 1 and the extending direction is parallel to the axial direction of the balloon, specifically, the axial direction of the balloon 1 is a straight line in a natural state, the extending direction of the first fibers 21 is parallel to the axial direction of the balloon 1, the second fibers 22 are spiral and extend from the proximal end to the distal end on the outer surface of the balloon 1, the first fibers 21 and the second fibers 22 form a staggered mesh structure, the outer surface of the balloon 1 can be fully coated, and the elastic modulus of the first fibers 21 and the second fibers 22 is greater than that of the balloon 1.

For example, as shown in fig. 2, the plurality of first fibers 21 located on the first side of the outer surface of the balloon 1 have continuously curved sections 211, the plurality of curved sections 211 form a flexible portion 201, the plurality of curved sections 211 may change from a curved state to a straightened state as the distal end of the balloon 1 is oriented or gradually inflated, such that the flexible portion 201 has a sufficient elongation, and the flexible portion 201 and the mating portion 202 may generate different restraining forces on opposite sides of the balloon 1 so that the balloon 1 fills into the curved state, and the plurality of curved sections 211 may gradually revert from the straightened state to the curved state when the balloon 1 is depressurized.

For example, as shown in fig. 3, the plurality of first fibers 21 located on the opposite side of the expansion and contraction portion 201 form the fitting portion 202, and the plurality of first fibers 21 constituting the fitting portion 202 do not extend or shorten, but are straightened or bent in the same direction in cooperation with the expansion and contraction portion 201, thereby collectively restraining the balloon 1 in the straightened state or the bent state.

In the present embodiment, in the balloon 1 in a natural state, the other portions of the plurality of first fibers 21 except for the bending section 211 are parallel to the axial direction of the balloon 1, and the bending section 211 continuously bends and extends in the axial direction of the balloon 1.

As shown in fig. 2, in this embodiment, the second fibers 22 are adhered to the outer surface of the balloon 1, the curved section 211 is not fixed to the outer surface of the balloon 1, and the first fibers 21 except for the curved section 211 are adhered to the outer surface of the balloon 1, so that most of the fiber woven layer 2 is fixed to the outer surface of the balloon 1, and the fiber woven layer can be synchronously shrunk or expanded along with the balloon 1, and meanwhile, the balloon 1 can be prevented from moving in the fiber woven layer 2, the expansion effect on the fiber woven layer 2 is affected, the curved section 211 and the outer surface of the balloon 1 are not fixed, so that the curved section 211 can be freely straightened or bent, and the whole covered balloon can be freely bent or straightened.

In this embodiment, the first fibers 21 and the second fibers 22 are fiber clusters formed by bundling a plurality of fiber filaments, the number of fiber filaments constituting the first fibers 21 and the second fibers 22 may be 3 to 100, the greater the number of fiber filaments, the greater the elastic modulus of the fiber woven layer 2, the better the pressure resistance, the smaller the number of fiber filaments, the smaller the elastic modulus of the fiber woven layer 2, and the smaller the size, and may be set according to different intravascular wall properties, thereby adaptively changing the pressure resistance and the size of the fiber woven layer 2.

In this embodiment, the diameter size of the filament is in the range of 0.010mm to 0.030mm, the tensile breaking strength of the filament is 3.0GPa to 4.0GPa, and the mesh size formed by braiding the first fibers 21 and the second fibers 22 on the fiber braid 2 is in the range of 200 μm to 800 μm.

In this embodiment, the fiber yarn is made of high-strength fiber compounded from one or more materials selected from the group consisting of poly (paraphenylene terephthalamide) fiber, aromatic polyamide copolymer fiber, heterocyclic polyamide fiber, carbon fiber, graphite fiber, and silicon carbide fiber.

In this embodiment, the material of the balloon is a polymer material, and may include one or more of polyvinyl chloride (PVC), polyethylene (PE), polyurethane (TPU), polyamide material (Nylon), polyether block polyamide (Pebax) material, polyethylene terephthalate (PET), and the like.

As shown in fig. 1 and 4, the present application provides a balloon catheter, which comprises a catheter 3 and the above-mentioned covered balloon, wherein the covered balloon is disposed at the distal end of the catheter 3, the balloon 1 comprises a balloon expansion section 101 which is in the middle and is in a cylindrical shape, a balloon distal end connecting section 102 and a balloon proximal end connecting section 103 which are in the shape of a truncated cone and are positioned at two axial ends of the balloon expansion section 101, and the balloon distal end connecting section 102 and the balloon proximal end connecting section 103 are respectively connected with the catheter 3.

The same structure as above, the distal end of the balloon distal connection section 102 is connected with balloon tube legs 11, the proximal end of the balloon proximal connection section 103 is also connected with balloon tube legs 11, and both balloon tube legs 11 are respectively connected with the catheter 3.

The catheter 3 may have a plurality of channels therein, such as a guidewire channel and a inflation channel, and the distal end of the catheter 3 may have a nozzle to facilitate insertion of a guidewire from the distal end of the guidewire channel and from the proximal end to guide movement of the catheter 3, and the inflation channel may be in communication with the lumen of the balloon 1 to facilitate inflation of the balloon 1 with liquid or gas by an external inflation device through the inflation channel.

The structure, composition, connection and function of the fiber braid 2 in this embodiment are identical to those of the fiber braid 2 described above, and the description thereof will not be repeated here.

Considering that the fiber braid 2 of the covered balloon increases the roughness of the outer surface of the balloon 1, and the covered balloon is subject to a large frictional resistance when moving in the blood vessel, in order to overcome the above problems, and ensure that the covered balloon moves smoothly in the blood vessel, as shown in fig. 5 and 6, the present application provides a balloon catheter assembly, which comprises the above balloon catheter, and further comprises a sleeve 4, wherein the catheter 3 is located in the inner cavity of the sleeve 4, the distal end of the sleeve 4 is provided with an expanding portion 41, and the covered balloon is adapted to contract and enter the expanding portion 41.

Before the tectorial membrane sacculus is inserted into a human body, the sleeve 4 can be sleeved on the catheter 3, the tectorial membrane sacculus is received into the expanding part 41 of the sleeve 4, the sacculus 1 and the fiber braiding layer 2 can shrink and stretch into the expanding part 41, the outer surface of the fiber braiding layer 2 is contacted with the inner wall of the expanding part 41, the expanding part 41 can replace the tectorial membrane sacculus to be contacted with the inner wall of a blood vessel, the friction resistance between the tectorial membrane sacculus and the inner wall of the blood vessel is reduced, meanwhile, the overstretching performance of the tectorial membrane sacculus can not be influenced, the sacculus catheter with the tectorial membrane sacculus is convenient to smoothly move in the blood vessel, the sleeve 4 can be withdrawn after the sacculus is moved to a focus position, and the sacculus 1 is gradually bent and expands the inner wall of the focus blood vessel under the constraint of the fiber braiding layer 2 along with the gradual filling of the sacculus 1.

As shown in fig. 5 and 6, in the present embodiment, a reducing portion 42 is provided between the expanding portion 41 and the sleeve 4, and the shape and size of the inner wall of the reducing portion 42 correspond to the shape and size of the outer wall of the proximal end of the balloon, so that on one hand, the stability of the balloon 1 can be improved, and on the other hand, the size of the outer edge of the sleeve 4 can be reduced, thereby facilitating smooth movement of the sleeve 4 in the blood vessel.

As shown in fig. 5 and 6, in the present embodiment, the distal end nozzle of the tube expanding portion 41 is provided with a chamfer 43, and the inclination of the chamfer 43 corresponds to the inclination of the distal end surface of the covered balloon, improving the smoothness of movement of the distal end nozzle of the tube expanding portion 41.

Although embodiments of the present invention have been described in connection with the accompanying drawings, various modifications and variations may be made by those skilled in the art without departing from the spirit and scope of the invention, and such modifications and variations fall within the scope of the invention as defined by the appended claims.

Claims

1. A membrane-covered saccule, characterized by comprising the following steps:

a balloon (1);

The fiber woven layer (2) is coated on the outer surface of the balloon (1) and is provided with a telescopic part (201) and a matching part (202), the telescopic part (201) is positioned on a first side of the balloon (1), the matching part (202) is positioned on a second side opposite to the first side of the balloon (1), when the balloon (1) is inflated, the telescopic part (201) and the matching part (202) are suitable for bending in the same direction, and the extension length of the telescopic part (201) is larger than the extension length of the matching part (202), so that the balloon (1) is bent;

The fiber woven layer (2) comprises first fibers (21) and second fibers (22), a plurality of the first fibers (21) are arranged on the outer surface of the balloon (1) at intervals, the extending direction of the first fibers is parallel to the axial direction of the balloon (1), the second fibers (22) are spiral and extend from the proximal end to the distal end on the outer surface of the balloon (1), the first fibers (21) on the first side of the outer surface of the balloon (1) are provided with continuously bent sections (211), the plurality of the bent sections (211) form the telescopic parts (201), and the first fibers (21) on the opposite side of the telescopic parts (201) form the matched parts (202);

The second fibers (22) are adhered to the outer surface of the balloon (1), the bending section (211) and the outer surface of the balloon (1) are not fixed, and the first fibers (21) except the bending section (211) are adhered to the outer surface of the balloon (1).

2. The covered balloon of claim 1, wherein the first fibers (21) and the second fibers (22) are filament bundles formed of a plurality of filament bundles.

3. The covered balloon of claim 2, wherein the fiber has a diameter dimension in the range of 0.010mm to 0.030mm and a tensile break strength of 3.0GPa to 4.0GPa.

4. The coated balloon of claim 2, wherein the fiber filaments are high strength fibers compounded from one or more of an aromatic polyamide co-polymer fiber, a heterocyclic polyamide fiber, a carbon fiber, and a silicon carbide fiber.

5. A balloon catheter, characterized by comprising a catheter (3) and the tectorial membrane balloon of any one of claims 1 to 4, wherein the tectorial membrane balloon is arranged at the distal end of the catheter (3), the balloon (1) comprises a balloon expansion section (101) which is positioned in the middle and is cylindrical, a balloon distal end connecting section (102) and a balloon proximal end connecting section (103) which are positioned at the two axial ends of the balloon expansion section (101) and are in a truncated cone shape, and the balloon distal end connecting section (102) and the balloon proximal end connecting section (103) are respectively connected with the catheter (3).

6. A balloon catheter assembly comprising the balloon catheter of claim 5, further comprising a cannula (4), the catheter (3) being located in the lumen of the cannula (4), the distal end of the cannula (4) being provided with an expanded portion (41), the covered balloon being adapted to be contracted and to enter the expanded portion (41).

7. The balloon catheter assembly according to claim 6, characterized in that a reducing portion (42) is provided between the expanding portion (41) and the sleeve (4), the shape and size of the inner wall of the reducing portion (42) corresponding to the shape and size of the outer wall of the proximal end of the covered balloon.

8. The balloon catheter assembly of claim 6, wherein the distal nozzle of the expanded section (41) is provided with a chamfer (43).