CN115487401A

CN115487401A - Anti-torsion balloon device

Info

Publication number: CN115487401A
Application number: CN202110682944.1A
Authority: CN
Inventors: 汝成韬; 马长生; 董建增; 桑才华; 李松南
Original assignee: Shanghai Keci Medical Technology Co ltd
Current assignee: Shanghai Keci Medical Technology Co ltd
Priority date: 2021-06-18
Filing date: 2021-06-18
Publication date: 2022-12-20

Abstract

The invention provides an anti-torsion bending balloon device which comprises a bending balloon and a catheter, wherein the bending balloon is bent to one side after being inflated, the catheter penetrates through the bending balloon and is connected with the bending balloon at two ends, and the anti-torsion bending balloon device is characterized in that the catheter is a braided tube with a braided layer. The invention has better bending property and distortion resistance.

Description

Anti-torsion balloon device

Technical Field

The invention relates to the field of medical instruments, in particular to a balloon device capable of resisting torsional bending.

Background

The general structure of the bending balloon is a bending balloon and an internal catheter. The catheter passes through the openings at the two ends of the balloon and penetrates through the balloon. The catheter in the balloon has an opening for injecting water or gas into the balloon. The general connection of the bending saccule and the catheter is that the saccule and the catheter are connected and the saccule is kept closed through connection technologies such as welding or bonding and the like at two ends of an opening of the bending saccule. Typically, the catheter is a polymeric tube, and may be single lumen or multi-lumen, but typically does not have any special structure, such as a braided structure.

The most basic principle of bending a balloon is that the bending of the balloon is caused by the fact that the outer material of the bending of the balloon has a greater elongation than the inner material. The general bending saccule is bent due to different elongation of the inner side and the outer side caused by the structure of the bending saccule, and the bending saccule also depends on the bent inner side of the bending saccule as a support with the unchanged length of the catheter, because the catheter is made of different materials from the saccule, the catheter cannot be elongated, and an effect that the length of the inner side is unchanged is provided for the bending saccule.

The first disadvantage is that: however, in actual use, since the catheter material is only a polymer material, but a general polymer material has plastic deformation capability, the bending force of the bending balloon becomes small and the bending effect becomes poor because the bending force of the catheter becomes long. Meanwhile, under the action of creep (the catheter is subjected to an elongation force for many times), the catheter is lengthened more obviously, and the performance of the bending balloon is reduced more seriously.

Meanwhile, the elongation deformation of the catheter is generally plastic deformation and cannot be recovered naturally, so that the elongation of the catheter can cause the pressure relief after the bending balloon is inflated, the bending balloon cannot be recovered to a linear state, the bending balloon is kept in a bending state all the time, and the subsequent use can be influenced.

The second disadvantage is that: in general, the performance of a conduit to transmit torque is very poor at high aspect ratios (conduit lengths are much larger than diameters). For example, applying a certain torque to the distal end of the catheter will generally distort the catheter and the torque transmitted to the proximal end will be greatly reduced. The performance in actual use is poor in transmitting rotation, which may only be 10 ° to the catheter of the proximally curved balloon segment after a 90 ° rotation of the distal end about the tubular axis, possibly due to twisting of the catheter of the intermediate segment. At the same time, the bending balloon has no good twisting resistance when being bent because the catheter does not resist twisting.

The third disadvantage is that: the general catheter material is not anti-bending, and after the bending balloon is bent, if a force is applied to the connecting part of the balloon and the catheter, the connecting part is very easy to bend to form an acute-angle crease, so that the use is very influenced.

There is therefore a need to provide a curved balloon solution that has better bending properties and better resistance to buckling, and that provides some bending support.

Disclosure of Invention

The invention aims to solve the problem of catheter extension in the prior art and improve the bending force of a bending balloon; when the bending saccule is inflated and bent, the pressure is released again, and the straight line state can be recovered; the capability of transmitting the torsion angle and the torque is improved, and the performance of twisting resistance is improved.

To achieve this object, the present invention provides a twist resistant balloon apparatus comprising a bending balloon which is bent to one side after filling and a catheter which is passed through the bending balloon and connected to the bending balloon at both ends, the catheter being a braided tube with a braided layer.

Wherein, the weaving material of weaving layer is stainless steel wire. Or the braided layer is made of nitinol wires. The woven material of the woven layer can also be nylon yarn. Or the weaving material of the weaving layer is high polymer material silk.

Furthermore, the section of the knitting yarn forming the knitting layer is flat. The cross-sectional shape of the braided wire may also be circular.

Preferably, the braided tube comprises an outer layer, a braided layer and an inner layer, wherein the outer layer is a polymer layer which is easily connected with the bending balloon material. The outer layer and the inner layer are made of TPU materials, and the bending saccule is also made of TPU materials. The outer layer and the inner layer of the braided tube are bonded together through the gaps of the braided layer.

The braided material of the braid is a first material in the curved balloon section and a second material in the non-curved balloon section, the first material being softer than the second material. Or the braided layer is braided sparsely on the braided tube part corresponding to the bending balloon section, and is braided densely on the braided tube part corresponding to the non-bending balloon section.

The outside cover of crooked sacculus has cylindric mesh grid, and the form of weaving is woven for the longitude and latitude quadrature, and the weft is the great not tensile material of intensity, and the warp is for can the elastic stretching material, and the diameter of mesh grid is greater than the sacculus initial diameter to close up at both ends. The tail end of the braided tube is provided with a tail end protection component, the tail end protection component is of a tubular structure, the tail end of the braided tube is a smooth round head, the hardness of the braided tube is softer than that of the catheter, and the connection part of the braided tube and the catheter structure is in smooth transition.

The invention has the beneficial effects that the equipment for improving the bending performance (bending force), the torque transmission performance (torsion resistance) and the fracture resistance of the torsion-resistant bending balloon is provided by technical means of adding a woven layer on the catheter, adopting the flat section, adopting materials with different hardness at different parts and the like.

In order to make the aforementioned and other objects, features and advantages of the present invention comprehensible, preferred embodiments accompanied with figures are described in detail below.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic diagram of one embodiment of the present invention.

FIG. 2 is a partial schematic view of the braided tube and curved balloon of the embodiment of FIG. 1.

FIG. 3 is a schematic cross-sectional view of a braided tube of the present invention.

Fig. 4 is a schematic diagram of another embodiment of the present invention.

Fig. 5 is a schematic cross-sectional view of the embodiment of fig. 4.

FIG. 6 is a schematic view of the embodiment of the tip section of FIG. 4.

Detailed Description

The technical solution 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. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the present invention without making any creative effort, shall fall within the protection scope of the present invention.

The present invention is described in further detail below to enable those skilled in the art to practice the invention with reference to the description.

Referring to fig. 1, fig. 1 is a schematic diagram of an embodiment of the invention. In this embodiment, the catheter of the curved balloon device is a braided tube 2, and the braided tube 2 is directly connected to both ends of the curved balloon 1. The middle part of the braided tube is a braided tube balloon section 4, and the two end parts are braided tube non-balloon sections 3. In the braided tube balloon section 4, the material can be selected to be soft, and the braiding pattern can be selected to be a scheme which is easy to bend (such as the braiding density is sparse), so that the bending balloon can be easier to bend without resistance. There will be water or gas injection openings in the braided tube balloon section 4. In the non-balloon section 3 of the braided tube, a certain supporting function needs to be provided, and a scheme that the material is harder and the braided pattern has better bending resistance (such as denser braided density) can be selected. Therefore, the supporting leg with smooth transition is arranged at the joint of the saccule and the braided tube after being stressed.

It is obvious that if the same material and the same density of the braided tube 2 are used separately, the catheter can also be protected from being bent easily under different stress conditions of the braided tube balloon section 4 and the braided tube non-balloon section 3. Meanwhile, the balloon has better torsion resistance and improves the traction force of the balloon after bending.

Referring next to fig. 2, fig. 2 is a partial schematic view of the braided tube and the bending balloon of the embodiment of fig. 1. A bending sacculus 1 and a conduit, wherein the conduit passes through the bending sacculus 1 and is connected with the bending sacculus 1 at two ends, and the conduit is a braided tube 2 with a braided layer. In some embodiments, the braided tube 2 is fixed against the inner side of the bending balloon 1, so that the braided tube 2 can fix and strengthen the shape and pulling force of the bent balloon 1 and is less prone to twist.

Finally, referring to fig. 3, fig. 3 is a cross-sectional view of the braided tube of the present invention. As can be seen from fig. 3, the braided tube 2 is located inside the curve of the curved balloon 1 and includes a braided tube outer layer 5, a braided tube braid layer 6, and a braided tube inner layer 7.

The braided material of the braided tube braid 6 located in the middle of the braided tube 2 includes, but is not limited to, stainless steel wires, nitinol wires, other metal wires, nylon wires, and other polymer material wires, wherein the stainless steel wires have a good effect, the cost is relatively low, and the purpose of the present invention can be preferably achieved. Nitinol wire, while relatively expensive, can be easily braided due to its good flexibility and memory characteristics, and returns to shape, suitable for use in high-end products.

Braided filament shapes include, but are not limited to, round filaments, flat filaments, and the like. The flat wire is more stable and stable in weaving and forming, more convenient to weave, and capable of better resisting distortion under the stress condition and protecting the catheter from being easily broken.

The inner layer 7 of the braided tube is made of any high polymer material and is selected according to requirements. The polymer material of the braided tube outer layer 5 is selected from materials which can be easily connected with balloon materials (for example, a balloon made of a TPU material, the outer layer made of the TPU material is selected, and the outer layer and the balloon can be well welded or bonded). TPU (Thermoplastic polyurethanes) is named as Thermoplastic polyurethane elastomer rubber, and is a high molecular material formed by jointly reacting diisocyanate molecules such as diphenylmethane diisocyanate (MDI) or Toluene Diisocyanate (TDI), etc., with macromolecular polyol and low-molecular polyol (chain extender) and polymerizing. The TPU has the excellent characteristics of high tension, high tensile force, toughness and aging resistance, and is a mature environment-friendly material. At present, the TPU is widely used in medical and health care, electronic and electric appliances, industry, sports and the like, has the incomparable characteristics of high strength, good toughness, wear resistance, cold resistance, oil resistance, water resistance, aging resistance, weather resistance and the like compared with other plastic materials, and has a plurality of excellent functions of high waterproofness, moisture permeability, wind resistance, cold resistance, antibiosis, mildew resistance, warm keeping, ultraviolet resistance, energy release and the like.

In general, the outer layer 5 and the inner layer 7 of the braided tube are polymer layers that are easily connected to the material of the bending balloon 1. The outer layer 5 and the inner layer 7 of the braided tube are bonded together through the gaps of the braided layer 6.

Referring to fig. 4, fig. 4 is a schematic diagram of another embodiment of the invention. In this embodiment, the catheter 2 is in the form of a braided tube. The bending saccule 1 is an eccentric multi-section saccule as shown in the figure, the saccule is made of thermoplastic polyurethane elastomer TPU, and two ends of the saccule can be directly welded with the catheter 2. The bending balloon 1 is a functional part of the device, providing the bending force. The bending saccule 1 is generally an eccentric saccule, the length of the saccule is larger than the initial diameter, and after a certain amount of fluid is filled into the saccule, the internal pressure of the saccule can cause the shape of the bending saccule 1 to be bent. The bending balloon 1 material is preferably a semi-compliant material, but may also be a compliant material. Openings are formed in two ends of the bending balloon 1 and are tightly connected with the catheter 2, and the connection mode is preferably welding, which can be ultrasonic welding, laser welding or hot melting welding; the connection mode can also be glue bonding.

The conduit 2 is the main component of the device for connection of other components; simultaneously transmitting torque for the whole device; a fluid charging and discharging passage is provided for the bending balloon 1; the function of fixing the length of the inner side of the bending saccule 1 is provided for the bending saccule 1; provides smooth support at both ends after the bending of the bending saccule 1. The catheter 2 can be a hard catheter made of non-compliant material, and can also be a braided tube, a hypotube or a snake bone tube, and is characterized in that the inner side of the bending balloon 1 is provided with constant fixed length limitation, and the bending balloon 1 can be bent to follow the bending form of the bending balloon 1 after being bent. The component is preferably a braided tube. The radial expansion limiting part 3 is a cylindrical woven mesh, the weaving mode is that warps and wefts are orthogonally woven, the wefts are made of non-stretchable materials with high strength, and the warps are made of elastically stretchable materials. The diameter of the woven mesh is larger than the initial diameter of the balloon, and the two ends are closed. The catheter 2 penetrates through the whole device, the catheter 2 penetrates through the curved balloon 1, a hole is formed in the middle section of the curved balloon 1 of the catheter 2 to provide a fluid charging and discharging passage for the curved balloon 1, and two ends of the curved balloon 1 are connected with the catheter 2; the bending saccule 1 is coated with a radial expansion limiting component, and the radial expansion limiting component is connected with the catheter 2; the end of the catheter 2 is connected with an end protection component 4.

The radial expansion restricting member 4 functions to restrict the expansion of the bending balloon 1 in the radial direction so that the bending balloon 1 does not expand any more after reaching a certain diameter in the radial direction. The radial expansion limiting member may be a mesh, sleeve or another balloon given a fixed diameter. The requirement of this element is that it is not radially expandable and does not constrain the balloon axially. The net cover woven by high polymer materials is preferably selected in the scheme. The mesh is substantially similar in shape to the balloon and needs to cover the balloon. The shape is generally cylindrical, and preferably the mesh sleeve has a smaller diameter at both ends than in the middle, being a closed cylindrical shape. The shape of the constriction is such as to facilitate connection to the catheter 2.

Referring to fig. 5, fig. 5 is a schematic cross-sectional view of the embodiment of fig. 4. In catheter 2, the same material used for inner layer 25 in both balloon section 22 and non-balloon section 21 is thermoplastic polyurethane elastomer TPU, which has the same inner diameter. The same braid form and braid material (stainless steel flat wire) is used for braid 24 in both balloon section 22 and non-balloon section 21. In the outer layer 23, the non-balloon section 21 uses a thermoplastic polyurethane elastomer TPU which is thicker and has higher hardness, so that the non-balloon section catheter

The diameter of 21 is larger (2.6 mm), and the texture is harder; the balloon section 22 is made of a thermoplastic polyurethane elastomer TPU with a relatively thin and low hardness, so that the balloon section 22 has a relatively small diameter (2.2 mm) and a relatively soft texture. The interface of the catheter balloon segment 22 and the non-balloon segment is within the balloon. Meanwhile, in the balloon section 22, a plurality of openings are arranged on the catheter 2 to be communicated with the inner cavity of the catheter, so that a liquid filling passage can be provided for the bending balloon 1. The inner layer polymer material is optional and is selected according to requirements; while the inner layer can be a single lumen tube or a multi-lumen tube. The outer layer polymer material is selected from materials which can be easily connected with the balloon material (for example, the balloon made of TPU material is selected, and the outer layer and the balloon can be well welded or bonded). Meanwhile, the weaving pattern of the weaving tube is not limited. The outer layer material and weave pattern may use different materials in the balloon and non-balloon sections. In the balloon section 22, the material can be selected to be soft, or the diameter can be small, or the weave pattern can be selected to be flexible (such as the weave density becomes sparse), so that the bending of the balloon 1 can be easier and free from resistance during the bending process. In the non-balloon section, it is desirable to provide some support, and the material may be selected to be stiffer, or larger in diameter, or in a weave pattern that is more resistant to bending (e.g., denser in weave density). Thus, the connecting part of the saccule and the braided tube is provided with a supporting leg which is smoothly transited after being stressed.

FIG. 6 is a schematic view of the embodiment of the tip section of FIG. 4. 10-20mm away from the joint of the bending balloon 1 and the catheter 2, the catheter is finished and is connected with a terminal protection component 4. The end protection member has the same diameter as the catheter 2 and is made of thermoplastic polyurethane elastomer TPU. The inner cavity of the distal end protective member 4 has a small diameter so that the distal end protective member 4 does not have a crease after bending. Meanwhile, the tail part of the tail end protection component 4 is subjected to round head treatment. The tip protector 4 provides a smooth and soft head at the tip of the entire device, protecting the user from injury during use. The component is a tubular structure with a diameter close to that of the catheter 2, is made of a high polymer material, and is generally made of a material which is easy to connect with the catheter 2. The member is softer in hardness than the catheter 2 and at the same time is less prone to sharp bending angles and does not produce sharp edges after bending. The tail end is a smooth round head, and the joint of the tail end and the catheter structure is in smooth transition.

While embodiments of the invention have been disclosed above, it is not intended to be limited to the uses set forth in the specification and examples. It can be applied to all kinds of fields suitable for the present invention. Additional modifications will readily occur to those skilled in the art. Therefore, the invention is not to be limited to the specific details and illustrations shown and described herein, without departing from the general concept defined by the claims and their equivalents.

Claims

1. An anti-torsion bending balloon device comprises a bending balloon and a catheter, wherein the bending balloon is bent to one side after being inflated, the catheter penetrates through the bending balloon and is connected with the bending balloon at two ends, and the anti-torsion bending balloon device is characterized in that the catheter is a braided tube with a braided layer.

2. The kink-resistant balloon apparatus according to claim 1, wherein the braided layer is a stainless steel wire.

3. The twist resistant balloon apparatus according to claim 1, wherein the braided layer is a nitinol wire.

4. The twist resistant balloon apparatus according to claim 1, wherein the braided layer is of nylon wire.

5. The twist resistant balloon apparatus according to claim 1, wherein the braided layer is a polymer material filament.

6. The twist resistant balloon apparatus according to claim 1, wherein the braided wire forming the braided layer is flat in cross-sectional shape.

7. The kink-resistant balloon apparatus according to claim 1, wherein the braided layer is comprised of braided filaments having a circular cross-sectional shape.

8. The twist resistant balloon apparatus according to claim 1, wherein the braided tube comprises an outer layer, a braided layer and an inner layer, the outer layer being a polymeric layer that is readily bondable to the material of the curved balloon.

9. The kink-resistant balloon apparatus according to claim 8, wherein the material of the outer and inner layers of the braided tube is a TP material and the curved balloon is a TPU material.

10. The kink-resistant balloon apparatus according to claim 8, wherein the outer and inner braided tubes are bonded together through interstices in the braided layers.

11. The twist resistant balloon apparatus according to claim 1, wherein the braided layer is a first material in the curved balloon section and a second material in the non-curved balloon section, the first material being softer than the second material.

12. The twist resistant balloon apparatus according to claim 1, wherein the braided layer is of a braided material that is less braided over the portion of the braided tube corresponding to the curved balloon section and more braided over the portion of the braided tube corresponding to the non-curved balloon section.

13. The balloon apparatus according to claim 1, wherein the curved balloon is externally covered with a cylindrical woven mesh, the woven mesh is formed by weaving warps and wefts orthogonally, the wefts are made of a strong non-stretchable material, the warps are made of an elastically stretchable material, and the diameter of the woven mesh is larger than the initial diameter of the balloon and is closed at both ends.

14. The twist resistant balloon apparatus according to claim 1, wherein the braided tube has a distal end with a distal end protector member, the distal end protector member having a tubular configuration with a smooth rounded distal end, a softer durometer than the catheter, and a smooth transition at the junction with the catheter structure.