CN110947082B - Balloon guiding catheter and preparation method thereof - Google Patents
Balloon guiding catheter and preparation method thereof Download PDFInfo
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- CN110947082B CN110947082B CN201911212631.9A CN201911212631A CN110947082B CN 110947082 B CN110947082 B CN 110947082B CN 201911212631 A CN201911212631 A CN 201911212631A CN 110947082 B CN110947082 B CN 110947082B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
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Abstract
The invention discloses a balloon guide catheter and a preparation method thereof. Wherein the outer pipe and the inner pipe are both formed by three-layer structures; the balloon guide catheter at least comprises 2 balloons which are arranged in series, and the inner diameter of the balloon at the far end of the catheter is smaller; the catheter end connected with the distal end of the inner tube is made of biomedical materials capable of promoting the regeneration of blood vessels. The balloon guide catheter provided by the invention can be used as a guide catheter to guide other interventional instruments into a focus position in interventional therapy, temporarily blocks the far end of a blood vessel through the expanded balloon, blocks blood flow, reduces the contraction time of the balloon, and can smoothly withdraw the catheter out of a body in time; meanwhile, the middle layer of the extra tube is of a foam structure, and the density of foam is smaller and smaller from the near end to the far end, so that the trackability of the catheter and the trafficability of complex tortuous vessels can be enhanced, the time of a patient for performing embolectomy is reduced, and the operability and efficiency of an interventional operation are improved.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a balloon guiding catheter and a preparation method thereof.
Background
The interventional technique of cerebrovascular diseases is taken as a representative minimally invasive treatment mode, in recent years, with the progress of imaging equipment, the introduction of novel interventional instruments is rapidly developed, cranial nerve interventional doctors can treat more and more complex lesions, more and more cases are applied clinically, and the related disease types are more and more extensive. The number of cases of interventional therapy of unicoronary heart disease in the united states alone reaches 90 ten thousand at present.
One of the conventional treatment methods of cerebral neurovascular, i.e., the venous thrombolytic treatment method of ischemic stroke, has the defects of short treatment time window (within 4.5 h), low revascularization rate (about 30 percent) and the like, and limits the curative effect and wide application of the method. In the vascular intervention treatment, when a catheter is operated in a blood vessel or a balloon, a stent or an occluder for interventional treatment is conveyed, debris emboli are generated to flow to the far end of the blood vessel, so that the far end blood vessel is occluded. For example, the incidence of myocardial necrosis caused by PCI in Percutaneous Coronary Intervention (PCI) is as high as 16% to 39%, and most of the reasons are that intravascular debris and plaque generated in the intervention operation block a distal blood vessel. Therefore, protecting the distal end of a blood vessel is an important issue in current interventional medicine during interventional diagnosis and treatment.
In interventional therapy such as minimally invasive interventional cerebral vessel thrombus removal process, the saccule is attached to a vessel wall through expansion of the saccule, and blood flow is temporarily blocked so as to protect a vessel far end. At the same time, the catheter is withdrawn by the contraction of the balloon to restore the recanalization of blood flow. But the sacculus guide pipe in the existing market is single sacculus guide pipe, when interveneeing the treatment, needs expand the sacculus as far as, makes the sacculus tightly attached in the vascular wall, and this will increase the stimulation to cranial nerve blood vessel, and the operation is intervened to great increase all kinds of complications, and the filling pressure of sacculus is big simultaneously, also can increase the cracked risk of sacculus.
Therefore, the key problem of interventional therapy is to find a method which can ensure that the contraction time of the saccule is not too long so as to withdraw the catheter in time; but also can ensure that the expansion pressure of the saccule is small and can not stimulate cerebral neurovascular; meanwhile, the balloon guide catheter can be ensured to have better flexibility and trafficability, and can cope with the thrombus lesion of complex tortuous vessels; the tail end of the catheter and the balloon should have good visibility, and the positions of the tail end of the catheter and the balloon can be accurately positioned in the interventional operation process.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provide a balloon guide catheter which can be used as a guide catheter to guide other interventional instruments into focus positions in interventional therapy, temporarily block the far end of a blood vessel through an expanded balloon, block blood flow, reduce the contraction time of the balloon and smoothly withdraw the catheter out of the body in time; meanwhile, due to the buffering effect of the double balloons, the double balloons can play a role in blocking blood flow under a smaller expansion state of the balloons, so that the stimulation to the wall of the cerebral neurovascular tube can be greatly reduced, and various complications and the risk of balloon fracture in the operation process can be reduced.
Meanwhile, the middle layer of the outer tube of the balloon guide catheter provided by the invention is of a foam structure, and the density of foam is smaller and smaller from the near end to the far end, so that the trackability of the catheter and the passability of complex tortuous vessels can be enhanced, the time of a patient for performing a embolectomy operation is reduced, and the operability and the efficiency of an interventional operation are improved.
Meanwhile, the tail end of the catheter is made of biological materials capable of promoting the regeneration of blood vessels, so that the injury to the blood vessels can be reduced, and the regeneration of the blood vessels can be promoted even if slight injury occurs in the clinical application.
In order to achieve the purpose, the technical scheme of the invention is as follows: the balloon guide catheter is sequentially provided with a Y-shaped joint, a diffusion stress tube, an outer tube and an inner tube from a near end to a far end. The side wall of the far end of the outer tube is provided with a liquid through hole, the outer side of the liquid through hole is provided with a balloon, the end part of the far end of the outer tube is connected with the tail end of the catheter, and the far end of the inner tube comprises a developing mark; the Y-shaped seat is provided with a main pore channel and a side pore channel, the inner cavity of the inner tube is a guide cavity, and the guide cavity is communicated with the main pore channel and is isolated from the side pore channel; a liquid through cavity is formed between the inner pipe and the outer pipe, the liquid through cavity is communicated with the side pore channel, the liquid through hole and the balloon, and the liquid through cavity is isolated from the main pore channel; the method is characterized in that: the outer layer and the inner layer of the outer pipe are both made of nylon elastomer, nylon or polyurethane, and the middle layer is made of polyurethane cotton; the inner layer of the inner pipe is made of polytetrafluoroethylene, the middle layer is a spiral spring, and the outer layer is made of nylon elastomer, nylon or polyurethane; the balloon guide catheter at least comprises 2 balloons which are arranged in series, and the inner diameter of the balloon at the far end of the catheter is smaller; the catheter end connected with the distal end of the inner tube is made of biomedical materials capable of promoting the regeneration of blood vessels.
Further, the outer layer of the outer tube of the balloon guide catheter is treated by a hydrophilic lubricating coating.
Further, the length of the balloon guide catheter is 80-120 mm.
Furthermore, the lubricating additive used for the hydrophilic lubricating coating treatment adopts a hydrophilic high-molecular additive, a hydrophilic nano high-molecular additive, a polyethylene glycol stearate material or a self-lubricating high-molecular material, and preferably polyvinylpyrrolidone.
Further, the density of the foam of the outer layer material of the outer tube is gradually reduced from the near end to the far end.
Further, the pitch of the helical spring of the middle layer of the inner tube is larger from the proximal end to the distal end.
Further, the end of the catheter connected with the distal end of the inner tube is composed of one or more of chitosan, polylactic acid, polyvinyl alcohol and collagen.
Furthermore, the filling capacity of the 2 balloons which are arranged in succession is 0.1-5ml, and the maximum diameter of the balloons is 3-25 mm.
Furthermore, the saccule is formed by continuously arranging 2 saccules made of different compliance materials;
furthermore, when the filling capacity of the balloon is 0.1-8ml, the maximum diameter of the balloon at the proximal end of the outer tube is 4-28mm, and the maximum diameter of the balloon at the distal end of the outer tube is 3-25 mm.
The preparation method of the balloon guide catheter comprises the following steps:
the method comprises the following steps: preparation of the outer tube
(1) Respectively sleeving an inner layer and an outer layer of an outer pipe into two metal pipe core rods which are connected at the bottom surfaces and have coaxial circular sections, blending a polyurethane reaction substance polyol component and an isocyanate component, injecting the mixture into the space between the inner pipe and the outer pipe of the sleeved circular metal pipe core rods through an injection machine, and simultaneously continuously adding a pore-forming agent into the mixture in the injection process, wherein the amount of the pore-forming agent is gradually increased and the proportion is 0.5-20%;
(2) after the crosslinking reaction is finished, soaking the molded outer tube in water for injection for 5-24hr to remove pore-forming agent to obtain outer tube;
(3) carrying out clear water coating treatment on the outer pipe;
step two: preparation of the inner tube
Sleeving an inner layer material, a metal wire and an outer layer material of the inner tube on a metal tube core rod in layers, arranging a developing mark between the inner layer material and the outer layer material at the far end, sleeving a fluorinated ethylene propylene copolymer heat-shrinkable tube on the outer surface, heating and shrinking the tube, cooling, peeling off the heat-shrinkable tube, and pulling out the core rod to finish the manufacture of the inner tube;
step three: bonding of balloons
Sleeving a metal core rod on the position 10cm-30cm away from the far end of the outer pipe, adding a fluorinated ethylene propylene heat-shrinkable pipe outside the metal core rod to perform heat shrinkage treatment on the metal core rod, cooling, peeling off the heat-shrinkable pipe, and drawing out the core rod to obtain a treated far end part with smaller outer diameter than other parts of the outer pipe; 4 liquid through holes are arranged at the part with smaller outer diameter, and 2 saccules are uniformly adhered to the far end part with the smaller inner diameter and the liquid through holes by medical glue;
step four: catheter tip
Injecting one or more of chitosan, collagen, polylactic acid and polyvinyl alcohol into a tubular mold for molding, and bonding the end of the inner tube, which is 1-5mm beyond the end, with medical adhesive;
step five: welding of distal and head ends of inner and outer tubes
Penetrating an inner pipe into an outer pipe, enabling the far end of the inner pipe to be exposed out of the outer pipe for 1-2 mm, then inserting a metal welding machine mandrel into the inner pipe from the far end of the inner pipe, overlapping the head end of the metal welding machine mandrel with the part of the inner pipe exposed out of the outer pipe, utilizing fluorinated ethylene propylene copolymer to thermally shrink the pipe, and welding at the temperature of 200-400 DEG F for 10-30 s;
step six: and (3) joint bonding: coating a layer of ultraviolet curing glue on the contact surface of the outer edge of the outer tube and the far end of the Y-shaped joint and the first contact surface of the outer edge of the inner tube and the near end of the Y-shaped joint, extending the near ends of the inner tube and the outer tube from the main inner hole of the far end of the Y-shaped joint to the assembly position, and then bonding the near ends of the inner tube and the outer tube by medical glue; the Y-shaped joint is made of polycarbonate.
Compared with the prior art, the invention has the following beneficial effects: the balloon guide catheter has flexibility and bending performance by adopting a foam structure of the outer tube and a metal wire structure of the inner tube, and can easily enter a bent blood vessel; the double-balloon guide tube is arranged, so that the double-balloon guide tube can be used as a guide tube to guide other interventional instruments into a focus position in interventional treatment, the far end of a blood vessel is temporarily blocked by the expanded balloon, the blood flow is blocked, the balloon contraction time is shortened, and the double-balloon guide tube can be timely and smoothly withdrawn from the body; meanwhile, due to the buffering effect of the double balloons on blood flow, the blood flow can be blocked under the state that the balloons are slightly expanded, the pressure and stimulation on cerebral nerve vessels can be avoided, and the complications such as vasospasm and the risk of balloon rupture are obviously reduced.
Drawings
FIG. 1 is a block diagram of a balloon guide catheter of the present patent;
FIG. 2 is a cross-sectional view of the balloon guide catheter of the present invention;
FIG. 3 is a cross-sectional view A-A of FIG. 2;
FIG. 4 is a schematic representation of the balloon of the present invention after inflation;
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In describing the embodiments of the present invention in detail, the drawings are not necessarily to scale, and the drawings are not intended to limit the invention.
Reference to "proximal" in the present patent refers to the end closer to the operator of the guiding catheter, and "distal" refers to the end farther from the operator of the guiding catheter.
Fig. 1 is a view showing a structure of a balloon guide catheter according to the present invention, fig. 2 is an axial sectional view of the balloon guide catheter shown in fig. 1, and fig. 3 is a cross-sectional view of the balloon guide catheter shown in fig. 2 in a transverse direction a-a. As shown in fig. 1, the balloon guide catheter includes: y type joint 1, diffusion stress pipe 2, outer tube 3 and inner tube 4. As shown in fig. 2, the side wall of the distal end of the outer tube is provided with a liquid through hole 5, the outer side of the liquid through hole is provided with a balloon 6, the end part of the distal end of the inner tube is connected with a catheter tip 7, and the distal end of the inner tube contains a developing mark 8; the Y-shaped seat is provided with a main pore channel 9 and a side pore channel 10, the inner cavity of the inner tube is a guide cavity 11, and the guide cavity is communicated with the main pore channel and is isolated from the side pore channel; a liquid through cavity 12 is formed between the inner pipe and the outer pipe, the liquid through cavity is communicated with the side pore canal, the liquid through hole and the balloon, and the liquid through cavity is isolated from the main pore canal.
As shown in fig. 2, the outer pipe and the inner pipe are both formed by three-layer structures; the outer layer and the inner layer of the outer tube are both made of nylon elastomer, nylon or polyurethane, and the middle layer 13 is made of polyurethane cotton; the outer layer of the inner pipe is made of nylon elastomer, nylon or polyurethane, the inner layer is made of polytetrafluoroethylene, and the middle layer is made of metal wires 14; as shown in fig. 4, the balloon guide catheter comprises at least 2 balloons arranged in series, and the inner diameter of the balloon at the distal end of the catheter is smaller; the end of the catheter connected with the distal end of the inner tube is made of biomedical materials which can promote the regeneration of blood vessels.
During specific application, implant the distal end of sacculus guide catheter to the sick position after, let in sacculus 6 with filling medium through leading to sap cavity 12 and liquid hole 5 to make 6 inflation of sacculus, shutoff blood flow, as shown in figure 4, only need carry out suitable filling to the sacculus this moment, utilize 2 continuous internal diameter grow gradually and the sacculus of continuous arrangement is used for shutoff blood flow to the cushioning effect of blood flow, in order to avoid the too much injury that leads to the fact the vascular wall of sacculus.
As shown in fig. 2 and 3, the balloon guide catheter of the present embodiment further increases the structural strength of the balloon guide catheter and ensures the flexibility of the balloon guide catheter by disposing foam in the outer tube.
The outer layer of the outer tube of the balloon guide catheter of the embodiment is treated by a hydrophilic lubricating coating: the lubricating additive used for the hydrophilic lubricating coating treatment adopts hydrophilic high polymer additive, hydrophilic nano high polymer additive, polyethylene glycol stearate material and self-lubricating high polymer material, and further preferably polyvinylpyrrolidone.
The length of the balloon guide catheter is about 80-120 mm.
The density of the foam of the outer layer material as the outer tube is gradually reduced from the near end to the far end.
In the embodiment, the metal wire used as the middle layer of the inner tube is a spiral spring with the gradually increased pitch from the near end to the far end; in another embodiment of the present invention, the wire used as the inner tube is constructed with a cross-shape that becomes larger from the proximal end to the distal end.
In the invention, as a material of the tail end of the catheter connected with the distal end part of the inner tube, one of chitosan, polylactic acid, polyvinyl alcohol and collagen can be selected. Preferably, the composition is a mixture of the above materials. The catheter tail end made of the biomaterial is soft and has certain strength, and in practical clinical application, the injury to blood vessels is avoided; even if it causes slight damage, regeneration of blood vessels can be promoted.
In this embodiment, the balloon 6 can be sleeved on the outer tube 3, as shown in fig. 4, preferably, the 2 balloons are parallel to the outer tube 3, so as to reduce the external dimension of the balloon guide catheter and facilitate implantation in the body. In addition, the sacculus department of outer tube is provided with logical liquid hole 5 respectively, and every leads to liquid hole and leads to the liquid chamber intercommunication. The number of the liquid through holes 5 is preferably multiple. A plurality of the liquid through holes 5 are distributed along the axial interval of the outer tube 3, so that the radial symmetrical distribution of the outer tube 3 can be simultaneously realized through the liquid through holes 5, namely the axial symmetry relative to the outer tube 3, the filling pressure is convenient to balance, and the adverse effect on the balloon guide tube caused by the filling or contraction of the balloon 6 is reduced.
In an embodiment of the invention, the maximum diameter of the balloon is 3-25mm in the inflated state.
In another embodiment of the invention, the maximum diameter of the balloon at the proximal end of the outer tube is 4-28mm and the maximum diameter of the balloon at the distal end of the outer tube is 3-25mm in the inflated state. Of course, the present invention includes but is not limited to these preferred dimensions, which are set according to the actual circumstances.
In view of the above, the present embodiment also provides a method for preparing a balloon guiding catheter, which mainly includes the following steps:
the method comprises the following steps: preparation of the outer tube
(1) Respectively sleeving an inner layer and an outer layer of an outer pipe into two metal pipe core rods which are connected at the bottom surfaces and have coaxial circular cross sections, blending a polyol component, an isocyanate component and water, injecting the mixture into the space between the sleeved circular two metal pipe core rods through an injection machine for forming, and continuously adding a pore-forming agent into the mixture in the injection process, wherein the amount of the pore-forming agent is gradually increased, and the proportion is 5-12%;
(2) after the crosslinking reaction is finished, soaking the molded outer tube in water for injection for 18hr to remove the pore-forming agent to obtain the outer tube;
(3) carrying out clear water coating treatment on the outer pipe;
the outer tube prepared by the step has the advantages that the structural strength is improved, and the flexibility is not reduced; the preparation process is simple and the cost is low;
step two: preparation of the inner tube
Sleeving an inner layer material, a metal wire and an outer layer material of the inner tube on a metal tube core rod in layers, arranging a developing mark between the inner layer material and the outer layer material at the far end, sleeving a fluorinated ethylene propylene copolymer heat-shrinkable tube on the outer surface, heating and shrinking the tube, cooling, peeling off the heat-shrinkable tube, and pulling out the core rod to finish the manufacture of the inner tube;
step three: bonding of balloons
Sleeving a metal core rod on the position 10cm-30cm away from the far end of the outer pipe, adding a fluorinated ethylene propylene heat-shrinkable pipe outside the metal core rod to perform heat shrinkage treatment on the metal core rod, cooling, peeling off the heat-shrinkable pipe, and drawing out the core rod to obtain a treated far end part with smaller outer diameter than other parts of the outer pipe; 4 liquid through holes are arranged at the position with smaller outer diameter; uniformly bonding 2 balloons at the distal end part with a smaller inner diameter and a liquid through hole by using medical glue;
step four: catheter tip
Injecting polylactic acid into a tubular mold to form the tail end of the catheter, and bonding the polylactic acid to the tail end of the inner tube by using medical glue and enabling the polylactic acid to exceed the tail end by 1-5 mm;
step five: welding of distal and head ends of inner and outer tubes
Penetrating an inner pipe into an outer pipe, enabling the far end of the inner pipe to be exposed out of the outer pipe for 1-2 mm, then inserting a metal welding machine core rod into the inner pipe from the far end of the inner pipe, overlapping the head end of the metal welding machine core rod with the part of the inner pipe exposed out of the outer pipe, utilizing fluorinated ethylene propylene copolymer to thermally shrink the pipe, and welding at the temperature of 150 ℃ for 30 s;
step six: joint bonding
And coating a layer of ultraviolet curing glue on the outer edge of the outer tube and the far-end contact surface of the Y-shaped joint of the polycarbonate, coating a layer of ultraviolet curing glue on the outer edge of the inner tube and the near-end first contact surface of the Y-shaped joint, extending the near ends of the inner tube and the outer tube from the far-end main inner hole of the Y-shaped joint to an assembly position, and bonding the near ends of the inner tube and the outer tube by using medical glue.
In summary, the balloon guide catheter provided by the invention, on one hand, the structural strength of the balloon guide catheter is enhanced through the foam structure of the outer tube, so that the balloon guide catheter is conveniently and smoothly pushed to improve the implantability of the balloon guide catheter when the in vivo implantation is performed, and on the other hand, the flexibility of the balloon guide catheter is increased through the gradual reduction of the foam density, the gradual reduction of the hardness of the metal wire and the gradual reduction of the hardness of the material of the outer tube; in clinical use, the balloon is only required to be inflated in a proper amount, and the blood flow is blocked by utilizing the buffering effect of the 2 balloons on the blood flow due to the different inner diameters and the continuous arrangement of the balloons; the damage of the excessive filling of the balloon to the blood vessel is avoided.
In addition, the number of the liquid through holes is multiple, the liquid through holes are distributed at intervals along the axial direction of the outer tube and are symmetrically distributed along the radial direction of the outer tube, so that the filling pressure can be increased, and the balloon can be rapidly inflated. Meanwhile, the foam structure of the outer tube can prevent the outer tube from collapsing on the inner tube when the balloon in an expansion state contracts, so that the balloon contracts slowly or even cannot contract, thereby prolonging the operation time and causing operation failure.
The above description is only for the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. That is, all equivalent changes and modifications made according to the content of the claims of the present invention should be within the technical scope of the present invention.
Claims (13)
1. A balloon guide catheter is characterized in that a Y-shaped joint (1), a diffusion stress tube (2), an outer tube (3) and an inner tube (4) are coaxially arranged from a near end to a far end to form a composite tube in sequence; the side wall of the far end of the outer tube is provided with a liquid through hole (5), the outer side of the liquid through hole is provided with a balloon (6), the end part of the far end of the inner tube is connected with the tail end (7) of the catheter, and the far end of the inner tube contains a developing mark (8); the Y-shaped joint is provided with a main pore channel (9) and a side pore channel (10), the inner cavity of the inner tube is a guide cavity (11), and the guide cavity is communicated with the main pore channel and is isolated from the side pore channel; a liquid through cavity (12) is formed between the inner pipe and the outer pipe, the liquid through cavity is communicated with the side pore canal, the liquid through hole and the balloon, and the liquid through cavity is isolated from the main pore canal; the method is characterized in that: the outer pipe and the inner pipe are both formed by three-layer structures; the outer layer and the inner layer of the outer pipe are both made of nylon elastomer, nylon or polyurethane, and the middle layer (13) is made of polyurethane cotton; the outer layer of the inner pipe is made of nylon elastomer, nylon or polyurethane, the inner layer is made of polytetrafluoroethylene, and the middle layer is made of metal wires (14); the balloon guide catheter at least comprises 2 balloons which are composed of compliant materials and are arranged in series, and the inner diameter of each balloon is gradually reduced from the proximal end to the distal end; the catheter end connected with the distal end of the inner tube is made of biomedical materials capable of promoting the regeneration of blood vessels.
2. The balloon guide catheter of claim 1, wherein: the length of the balloon guide catheter is 45-120 cm.
3. The balloon guide catheter of claim 1, wherein: the outer layer of the outer tube of the balloon guide catheter is treated by a hydrophilic lubricating coating.
4. The balloon guide catheter of claim 1, wherein: the compliant material for forming the balloon is one of silica gel, latex and TPU.
5. The balloon guide catheter of claim 3, wherein: the lubricating coating used for the hydrophilic lubricating coating treatment is a hydrophilic polymer material mixed with one or more of polyvinylpyrrolidone, sodium hyaluronate, carboxymethyl cellulose, hydroxyethyl cellulose and polyglutamic acid.
6. The balloon guide catheter of claim 1, wherein: the density of the foam of the outer layer material of the outer tube is gradually reduced from the near end to the far end.
7. The balloon guide catheter of claim 1, wherein: the metal wire of the inner tube middle layer is composed of a spiral spring with the thread pitch gradually increasing from the near end to the far end.
8. The balloon guide catheter of claim 1, wherein: the metal wire of the inner tube is formed by a # -shaped structure which is gradually enlarged from the near end to the far end.
9. The balloon guide catheter of claim 1, wherein: the end of the catheter connected with the distal end of the inner tube is composed of one or a mixture of chitosan, polylactic acid, polyvinyl alcohol and collagen.
10. The balloon guide catheter of claim 1, wherein: the filling capacity of the 2 balloons which are continuously arranged is 0.1-5ml, and the maximum diameter of the balloons is 3-25 mm.
11. The balloon guide catheter of claim 1, wherein: the sacculus is formed by continuously arranging 2 sacculus made of different compliance materials.
12. The balloon guide catheter of claim 8, wherein: when the filling capacity is 0.1-8ml, the maximum diameter of the balloon at the proximal end of the outer tube is 4-28mm, and the maximum diameter of the balloon at the distal end of the outer tube is 3-25 mm.
13. A method of making a balloon guide catheter as in any of claims 1-10, comprising the steps of:
the method comprises the following steps: preparation of the outer tube
Respectively sleeving an inner layer and an outer layer of an outer pipe into two metal pipe core rods which are connected at the bottom surfaces and have coaxial circular cross sections, blending a polyurethane reaction substance polyol component and an isocyanate component, injecting the mixture into the space between the sleeved circular two metal pipe core rods through an injection machine for molding, and continuously adding a pore-forming agent into the mixture in the injection process, wherein the amount of the pore-forming agent is gradually increased, and the proportion is 0.5-20%;
after the crosslinking reaction is finished, soaking the molded outer tube in water for injection for 5-24hr to remove pore-forming agent to obtain outer tube;
carrying out hydrophilic coating treatment on the outer tube;
step two: preparation of the inner tube
Sleeving an inner layer material, a metal wire and an outer layer material of the inner tube on a metal tube core rod in layers, arranging a developing mark between the inner layer material and the outer layer material at the far end, sleeving a fluorinated ethylene propylene copolymer heat-shrinkable tube on the outer surface, heating and shrinking the tube, cooling, peeling off the heat-shrinkable tube, and pulling out the core rod to finish the manufacture of the inner tube;
step three: bonding of balloons
Sleeving a metal core rod on the position 10cm-30cm away from the far end part of the outer pipe, adding a fluorinated ethylene propylene heat-shrinkable pipe outside the metal core rod to perform heat shrinkage treatment on the metal core rod, cooling, peeling off the heat-shrinkable pipe, and pulling out the core rod, wherein the outer diameter of the treated far end part is smaller than that of other parts of the outer pipe; a plurality of liquid through holes are arranged at the part with smaller outer diameter, and 2 balloons are uniformly adhered to the distal end part with the smaller inner diameter and the liquid through holes by medical glue;
step four: catheter tip
Injecting one or more of chitosan, collagen, polylactic acid and polyvinyl alcohol into a tubular mold for molding, and bonding the end of the inner tube, which is 1-5mm beyond the end, with medical adhesive;
step five: welding of distal and head ends of inner and outer tubes
Penetrating an inner pipe into an outer pipe, enabling the far end of the inner pipe to be exposed out of the outer pipe for 1-2 mm, then inserting a metal welding machine core rod into the inner pipe from the far end of the inner pipe, overlapping the head end of the metal welding machine core rod with the part of the inner pipe exposed out of the outer pipe, utilizing fluorinated ethylene propylene copolymer to thermally shrink the pipe, and welding at the temperature of 90-200 ℃ for 10-30 s;
step six: and (3) joint bonding: coating a layer of medical adhesive on the contact surface of the outer edge of the outer tube and the far end of the Y-shaped joint and the first contact surface of the outer edge of the inner tube and the near end of the Y-shaped joint, extending the near ends of the inner tube and the outer tube from the main inner hole of the far end of the Y-shaped joint to the assembly position, and then bonding the near ends of the inner tube and the outer tube by using the medical adhesive; the Y-shaped joint is made of polycarbonate.
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| CN111701139A (en) * | 2020-05-29 | 2020-09-25 | 广州新诚生物科技有限公司 | Encephalic balloon catheter and preparation method thereof |
| CN112472969A (en) * | 2020-12-15 | 2021-03-12 | 上海市东方医院（同济大学附属东方医院） | Fistulous tract automatic expansion type puncture drainage tube |
| CN114796809A (en) * | 2022-03-30 | 2022-07-29 | 深圳市顺美医疗股份有限公司 | Balloon guide catheter |
| CN117159813A (en) * | 2023-09-08 | 2023-12-05 | 浙江海圣医疗器械股份有限公司 | Medical catheter with hydrophilic coating and preparation method thereof |
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