CN112704802A - Balloon dilatation catheter and preparation method thereof - Google Patents
Balloon dilatation catheter and preparation method thereof Download PDFInfo
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- CN112704802A CN112704802A CN201911021904.1A CN201911021904A CN112704802A CN 112704802 A CN112704802 A CN 112704802A CN 201911021904 A CN201911021904 A CN 201911021904A CN 112704802 A CN112704802 A CN 112704802A
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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
- A61M25/1027—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
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
-
- 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
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- 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
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
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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
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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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
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- 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
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
-
- 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
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
Abstract
The invention discloses a balloon dilatation catheter and a preparation method thereof, the catheter comprises a catheter seat, a hypotube connected to the catheter seat, an outer tube connected to the end of the hypotube, an inner tube arranged inside the outer tube, a balloon connected to the outer tube and a tip connected to the balloon, and the outer tube and the inner tube are provided with a guide wire port, and the balloon dilatation catheter is characterized in that: the balloon dilatation catheter is characterized in that the inner wall of the outer tube and/or the outer wall of the inner tube are/is provided with the enhancement layer, the size of the excircle of the enhancement layer is gradually reduced from a hypotube to the tip part along the inner wall of the outer tube and/or the outer wall of the inner tube.
Description
Technical Field
The invention relates to an operation instrument in the medical field, in particular to a novel balloon dilatation catheter for interventional therapy and a preparation method thereof.
Background
Interventional medicine is a new interdisciplinary subject integrating image diagnosis and clinical treatment. Under the guidance of medical imaging equipment, the diagnosis and treatment of diseases are completed by minimally invasive technology through instrument operation. In recent years, the nation has advocated and promoted interventional therapy, aiming at maintaining the normal structure and functions of the human body while eliminating the pain of the patient, curing the disease of the patient, and recovering the health of the patient with the best curative effect, the minimum trauma and the minimum cost.
The balloon dilatation catheter is one of interventional therapy medical instruments and can be used for dilating a narrow diseased blood vessel of a patient and improving blood flow; can also be used for delivering the implant to the narrow lesion of the patient, and plays a very important role in interventional clinical operation. At present, a balloon dilatation catheter mainly has two structures, one is coaxial propelling expansion, and the other is rapid exchange propelling expansion. In a coaxial structure, a guide wire cavity penetrates through the whole catheter, so that the guide wire has strong capability of passing through a lesion part, but the guide wire is often operated by multiple persons; in the rapid exchange structure, the guide wire cavity is short, the guide wire is inserted from the far end of the catheter and is penetrated out from the opening on the side wall, the operation can be completed by a single person, but the capability of the guide wire passing through the lesion part is slightly poor, and the operation difficulty is easily caused. Most of the existing balloon dilatation catheters consist of a catheter seat, a hypotube, a catheter, a balloon, a ray detectable mark, a balloon protective sleeve and a supporting wire. In order to maintain the operation advantages of the balloon dilatation catheter with the rapid exchange structure, improve the ability of the balloon dilatation catheter to pass through diseased parts, especially seriously calcified diseases, shorten the operation time and improve the success rate of the operation, the prior art mostly adopts the design of changing the distal end configuration of the hypotube to improve the propelling property of the balloon catheter and promote the balloon to smoothly pass through diseased blood vessels. Although the propelling performance of the balloon catheter can be effectively adjusted to a certain extent through different design of the distal end configuration of the hypotube, the structure of the distal end assembly of the balloon catheter is not changed fundamentally, and when the propelling force is transmitted to the distal end of the balloon catheter through the distal end of the hypotube, the high polymer material property of the balloon catheter reduces the efficiency of the propelling force reaching the tip of the balloon catheter along with partial energy loss, and the capability of the balloon catheter to pass through vascular lesions is weakened, particularly the operation condition of severe calcification lesions.
Therefore, the technical problem to be solved by those skilled in the art is how to provide a balloon dilatation catheter which has a strong ability to pass through a lesion site and has the operation advantages of a rapid exchange type balloon dilatation catheter.
Disclosure of Invention
Aiming at the problems in the prior art, the invention aims to provide a balloon dilatation catheter which is novel in structure and can pass through a lesion part, and a preparation method of the balloon dilatation catheter, so as to solve the problems of weak ability of a guide wire to pass through the lesion part, adhesion of balloon walls and folding of a distal end assembly.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the utility model provides a sacculus expansion pipe, includes the pipe seat, connects the hypotube on the pipe seat, connects the outer tube at the hypotube tip, sets up at the inside inner tube of outer tube, is connected to the sacculus of outer tube, is connected to the pointed end of sacculus, outer tube and inner tube department are formed with wire guide mouth, its characterized in that: the outer pipe inner wall and/or the inner tube outer wall are/is provided with a reinforcing layer, and the size of the outer circle of the reinforcing layer is gradually reduced along the outer pipe inner wall and/or the inner tube outer wall from the direction of the top end of the hypotube.
Further, the enhancement layer is connected with the hypotube in an integrated or split manner, and the enhancement layer extends to the tip portion from the hypotube.
Further, the reinforcement layer is made of medical metal wire-wound springs with the same or different pitches, and can also be realized by medical metal wire-wound springs or other structures with the same or similar functions.
Further, the reinforcing layer is made of medical metal wire wound springs with different pitches, and the reinforcing layer at the balloon is of a metal wire structure instead of a wound spring structure wound on the inner tube.
Further, the reinforcing layer 9 at the wire guide opening has a large pitch and effectively avoids the wire guide opening.
Further, the inner tube, the reinforcement layer, the balloon pins and the tip portion are welded into an integral distal end portion by overlap welding or butt welding.
Furthermore, the inner tube in the saccule is provided with a ray detectable mark, and the ray detectable mark is formed by gold or a local coating of a gold coating coil outside the reinforcing layer.
The preparation method of the balloon dilatation catheter is characterized by comprising the following steps of:
s1, preparing a cut at a proper position of the side wall of the outer tube, and welding the far end of the outer tube and the balloon into a whole;
s2, arranging the reinforcing layer into the outer tube and fixing;
s3, the inner tube is arranged inside the outer tube through the cut prepared in the step S1, the inner tube is positioned inside the enhancement layer, the far end of the inner tube penetrates through the saccule to reach the tip part, and the near end of the inner tube and the outer tube are welded and fixed into a whole at the cut to form a guide wire opening;
s4, welding the far end of the inner tube, the far end of the reinforcing layer, the balloon pin and the tip part into a whole to form a far end part; and welding the near end of the outer pipe and the hypotube into a whole.
Further, the steps S3, S4 are:
s3, placing the inner tube in the reinforcing layer, then inserting the inner tube with the reinforcing layer into the outer tube through the far end of the balloon to reach the notch prepared in the step S1, and then welding the near end of the outer tube and the hypotube into a whole;
s4, welding and fixing the near end of the inner tube and the outer tube into a whole at the notch to form a wire guide port; and welding the far end of the inner tube, the far end of the reinforcing layer, the balloon pin and the tip part into a whole to form a far end part.
Further, the welding method is hot air or laser welding, and the reinforcing layer is in interference fit with the inner wall of the outer pipe or is fixed by heating.
Compared with the prior art, the balloon dilatation catheter provided by the invention has an unusual structure, and has the following advantages because of the structure of the reinforcing layer:
1. the balloon dilatation catheter developed by the invention has the structural design of the wire guide port of the traditional balloon dilatation catheter with the rapid exchange structure, the wire guide penetrates through the far end of the catheter, the wire guide port on the side wall penetrates out, the wire guide cavity is short, and the operation advantage of a single person is kept.
2. The enhancement layer is added in the outer tube, so that the strength and toughness of the distal end assembly of the balloon dilatation catheter are improved, and the pushing force transmission efficiency is improved;
3. the reinforcing layer can extend to the tip part of the balloon dilatation catheter, the overall dimension of the reinforcing layer is gradually reduced from the far end of the balloon to the tip part, the energy loss of the high polymer material component is effectively reduced, and the capability of the high polymer material component for passing through a blood vessel lesion part is improved.
4. The enhancement layer is constituteed jointly with both ends spring enhancement layer to the pliable and tough wire in the sacculus, can effectively avoid the sacculus wall adhesion, when promoting propelling movement power conveying efficiency, helps the sacculus to pass through the narrow pathological change of serious calcification.
5. The gold or the gold coating coil is used as the detectable mark, so that the risk of displacement, deformation, even cracking and falling of the detectable mark caused by the existing crimping process is fundamentally reduced, and the clinical use safety of the product is improved.
6. The invention can effectively reduce the damage risk such as folding of the balloon distal end assembly and the like under the condition of not using the supporting wire.
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, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic structural view of the present invention;
FIG. 2 is a schematic structural diagram of an embodiment of the present invention;
FIG. 3 is a schematic structural diagram of another embodiment of the present invention;
FIG. 4 is an enlarged partial schematic view A of FIG. 2;
FIG. 5 is an enlarged partial view B of FIG. 2;
FIG. 6 is an enlarged partial schematic view C of FIG. 2;
FIG. 7 is an enlarged partial schematic view D of FIG. 3;
fig. 8 is a partially enlarged view E of fig. 3.
In the figure, 1 catheter hub, 2 hypotube, 3 outer tube, 4 inner tube, 5 balloon, 6 radiodetectable markers, 7 tip, 8 support mandrel, 9 reinforcement layer, 10 distal tip, 11 guidewire port.
Detailed Description
The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying 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. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
As shown in fig. 1-8, a balloon dilatation catheter comprises a catheter base 1, a hypotube 2 connected to the catheter base 1, an outer tube 3 connected to the end of the hypotube 2, an inner tube 4 arranged inside the outer tube 3, a balloon 5 connected to the outer tube 3, and a tip 7 connected to the balloon 5, wherein a guide wire port 11 is formed at the outer tube 3 and the inner tube 4, a reinforcement layer 9 is arranged on the inner wall of the outer tube 3 and/or the outer wall of the inner tube 4, and the outer circle size of the reinforcement layer 9 is gradually reduced from the hypotube 2 to the tip 7 along the inner wall of the outer tube 3 and/or the outer wall of the inner tube 4. The hypotube 2 and the reinforcement layer may be an integral structure or may be independent structures.
In this embodiment, catheter hub 1 is a standard luer fitting, and catheter hub 1 and hypotube 2 are physically connected together. The outer tube 3 is a hollow structure, and the near end of the inner tube 4 and the outer tube 3 are fixedly connected at the cut of the wall of the outer tube in a sealing way to form a wire guide port 11. The distal end of the inner tube 4, the distal end of the balloon, the distal end of the reinforcing layer and the tip portion 7 are connected in a sealing and fixing manner to form a configuration of a distal end portion 10. The guide wire opening 11, the inner cavity of the inner tube 4 and the inner cavity of the tip part 7 form a guide wire passage.
Moreover, in order to improve the transmission efficiency of the pushing force from the hypotube 2 to the tip part 7 or the distal end part 10, the invention is provided with the reinforcing layer 9 in the outer tube 3, the reinforcing layer 9 reaches the proximal end of the balloon 5, penetrates through the whole balloon 5 in a micro-wire form, and extends to the tip part 7 of the balloon dilatation catheter in a spring structure or other structures with the same or similar functions, so that the strength and the toughness of the distal end component of the balloon dilatation catheter are increased together, the energy loss of the high polymer material component is effectively reduced, and the capability of the distal end component of the balloon dilatation catheter for passing through the vascular lesions. The reinforced layer 9 is provided with a thread pitch structure which is kept unchanged or changes in a segmented gradient manner, extends to the tip part 7 of the balloon dilatation catheter and gradually reduces the external dimension.
A more rigorous interpretation is: the enhancement layer 9 is connected with the hypotube 2 in an integrated or split manner, and the enhancement layer 9 extends from the hypotube 2 to the tip portion 7. The reinforcement layer 9 is made of medical metal wire wound springs of the same or different pitches.
Wherein, the reinforcing layer 9 is made of medical metal wire wound springs with different pitches, and the reinforcing layer 9 at the balloon 5 is of a metal wire structure instead of a wound spring structure wound on the inner tube 4. The thread pitch of the enhancement layer 9 at the thread guide opening 11 is large, and the enhancement layer effectively avoids the thread guide opening 11. The reinforcing layer 9 and the outer tube 3 can be combined to a higher degree by interference fit and/or heat conduction, and the interference fit enables the reinforcing layer 9 to be tightly attached to the inner wall of the outer tube 3 after being sent into the outer tube 3 and clamped at a corresponding position. That is, the reinforcing layer 9 is fixed to the inner wall of the outer tube 3 by interference fit or heating. The manner of bonding the reinforcing layer 9 to the outer tube 3 is not limited to the manner exemplified in the examples, and any method having the same effect may be used. The inner tube 4, the reinforcing layer 9, the saccule 5 pins and the tip part 7 are welded into an integral distal end part 10 through overlap welding or butt welding. The inner tube 4 inside the balloon 5 is provided with a radiation detectable mark 6, and the radiation detectable mark 6 is formed by partially coating gold or a gold-coated coil outside the reinforcing layer 9. Enhancement layer 9 in sacculus 5 in this embodiment is pliable and tough wire shape, and both ends spring enhancement layer 9, hypotube 2 structure as an organic whole effectively reduce macromolecular material subassembly energy loss, when promoting propelling movement power transmission efficiency, can help sacculus 5 to through narrow pathological change to can effectively avoid the adhesion of sacculus wall.
The present embodiment also provides a method for preparing the balloon dilatation catheter, which includes the following steps:
s1, preparing a notch at a proper position on the side wall of the outer tube 3, and welding the far end of the outer tube 3 and the balloon 5 into a whole;
s2, installing the reinforcing layer 9 into the outer tube 3 and fixing;
s3, the inner tube 4 is arranged inside the outer tube 3 through the cut prepared in the step S1, the inner tube 4 is positioned inside the enhancement layer 9, the far end of the inner tube 4 penetrates through the saccule 5 to reach the tip part 7, and the near end of the inner tube 4 and the outer tube 3 are welded and fixed into a whole at the cut to form a guide wire port;
s4, welding the far end of the inner tube 4, the far end of the reinforcing layer 9, the base pin of the saccule 5 and the tip part 7 into a whole to form a far end part 10, and welding the near end of the outer tube 3 and the hypotube 2 into a whole.
Wherein, the steps S3, S4 may be replaced as follows:
s3, placing the inner tube 4 inside the reinforcing layer 9, then penetrating the inner tube 4 with the reinforcing layer 9 through the far end of the balloon 5 to reach the cut prepared in the step S1, and installing the cut inside the outer tube 3, and then welding the near end of the outer tube 3 and the hypotube 2 into a whole;
s4, welding and fixing the near end of the inner tube 4 and the outer tube 3 at the notch to form a guide wire port; the distal end of the inner tube 4, the distal end of the reinforcing layer 9, the base pin of the balloon 5 and the tip part 7 are welded into a whole to form a distal end part 10.
In addition, the welding method according to the present embodiment is hot air or laser welding.
The general more detailed manufacturing method is as follows: a cutting opening is formed at a proper position of the outer tube 3 through an incision tool, the pitch of the reinforcing layer 9 at the position can be properly expanded to ensure that the length of the cutting opening is proper, and the cutting opening is fixedly connected with the inner tube 4 to form a guide wire opening 11 which is used as a guide wire outlet matched with the balloon catheter; the near ends of the outer tube 3 and the balloon 5 are fixedly connected, and the fixing can be realized by hot air or laser welding or any processing method with similar or equivalent effect; the far end of the reinforcing layer 9 is sent into the outer tube 3, the reinforcing layer 9 and the outer tube 3 can be fixed in an interference fit or heating mode, the near end of the outer tube 3 and the far end of the hypotube 2 can be fixed in a hot air or laser welding mode or realized by using any processing method with similar or equivalent effect; the inner tube 4 passes through the far-end inner wall of the reinforcing layer 9, penetrates through the balloon 5 and reaches the cutting opening, and can be processed and formed into a guide wire opening 11 by hot air or laser welding or any processing method with similar or equivalent effect; the distal end part 10 of the balloon catheter is formed by hermetically fixing the distal end part 7, the distal end of the balloon 5, the distal end of the reinforcing layer 9 and the distal end of the inner tube 4 in a heat conduction manner, wherein the heat conduction manner can be hot air conduction or laser conduction or any heat conduction manner with similar or equivalent effect.
The more detailed explanation is: the inner tube 4 is a hollow structure, and is externally designed with a reinforcing layer, the reinforcing layer can be a medical metal spring structure or other structures with the same or similar functions, and the thread pitch of the reinforcing layer is kept unchanged or is changed in a segmented gradient manner. The near end of the inner tube 4 is fixedly connected with the outer tube 3 at the opening of the outer tube wall in a sealing way to form a guide wire opening. The distal end of the inner tube 4 is fixedly connected with the distal end of the balloon 5 and the tip 7 through heat conduction sealing to form a tip 7 structure. The guide wire opening, the inner cavity of the inner tube 4 and the inner cavity of the tip end 7 form a guide wire passage.
On the basis, a novel ray detectability marking method is provided, gold or a gold coating coil or a spring layer local coating is directly used as a detectable mark, the mark can be realized by a gold or gold coating wire through a spring winding process, the mark is placed into an inner tube outer spring enhancement layer 9 to be fixed, the mark and the spring enhancement layer 9 can be of an integral structure, the inner tube outer enhancement layer and the spring winding process are synchronously realized, and the ray detectability mark of the integral structure type is recommended to be used in the embodiment. The risk of displacement, deformation, even cracking and falling of the detectable mark caused by the existing pressing and holding process can be fundamentally reduced, and the safety of clinical use of the product is improved.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. The utility model provides a sacculus expansion pipe, includes pipe seat (1), connects hypotube (2) on pipe seat (1), connects outer tube (3) at hypotube (2) tip, sets up inner tube (4) inside outer tube (3), is connected to sacculus (5) of outer tube (3), is connected to tip (7) of sacculus (5), outer tube (3) and inner tube (4) department are formed with wire guide mouth (11), its characterized in that: the inner wall of the outer tube (3) and/or the outer wall of the inner tube (4) are/is provided with a reinforcing layer (9), and the outer circle size of the reinforcing layer (9) is gradually reduced from the hypotube (2) to the tip part (7) along the inner wall of the outer tube (3) and/or the outer wall of the inner tube (4).
2. The balloon dilation catheter according to claim 1, wherein: the enhancement layer (9) is connected with the hypotube (2) in an integrated or split mode, and the enhancement layer (9) extends from the hypotube (2) to the tip portion (7).
3. The balloon dilation catheter according to claim 2, wherein: the reinforcement layer (9) is made of medical metal wire wound springs with the same or different pitches.
4. The balloon dilation catheter according to claim 3, wherein: the reinforcing layer (9) is made of medical metal wire wound springs with different screw pitches, and the reinforcing layer (9) at the balloon (5) is of a metal wire structure instead of a wound spring structure wound on the inner tube (4).
5. The balloon dilation catheter according to claim 3, wherein: the thread pitch of the enhancement layer (9) positioned at the thread guide opening (1) is large, and the thread guide opening (11) is effectively avoided.
6. The balloon dilation catheter according to claim 1, wherein: the inner tube (4), the reinforcing layer (9), the sacculus (5) pin and the tip part (7) are welded into an integral far end part (10) through overlap welding or butt welding.
7. The balloon dilation catheter according to claim 1, wherein: the inner tube (4) in the sacculus (5) is provided with a ray detectable mark (6), and the ray detectable mark (6) is formed by gold or a gold coating coil on a local coating on the outer side of the enhancement layer (9).
8. A method of manufacturing a balloon dilation catheter according to any one of claims 1 to 7, wherein the method of manufacturing comprises the steps of:
s1, preparing a cut at a proper position on the side wall of the outer tube (3), and welding the far end of the outer tube (3) and the balloon (5) into a whole;
s2, placing the reinforcing layer (9) into the outer tube (3) and fixing;
s3, the inner tube (4) is arranged inside the outer tube (3) through the cut prepared in the step S1, the inner tube (4) is located inside the reinforcing layer (9), the far end of the inner tube (4) penetrates through the balloon (5) to reach the tip end portion (7), and the near end of the inner tube (4) and the outer tube (3) are welded and fixed into a whole at the cut to form a guide wire opening;
s4, welding the far end of the inner tube (4), the far end of the reinforcing layer (9), the base pin of the saccule (5) and the tip part (7) into a whole to form a far end part (10); the near end of the outer tube (3) and the hypotube (2) are welded into a whole.
9. The method of claim 8, wherein the steps S3 and S4 are:
s3, placing the inner tube (4) inside the reinforcing layer (9), then penetrating the inner tube (4) with the reinforcing layer (9) through the far end of the balloon (5) to the cut prepared in the step S1, installing the inner tube into the outer tube (3), and then welding the near end of the outer tube (3) and the hypotube (2) into a whole;
s4, welding and fixing the near end of the inner tube (4) and the outer tube (3) at the incision to form a guide wire opening, and welding the far end of the inner tube (4), the far end of the reinforcing layer (9), the base pin of the saccule (5) and the tip part (7) to form a far end part (10).
10. The method of manufacturing a balloon dilation catheter according to claim 8, wherein: the welding method is hot air or laser welding, and the reinforcing layer (9) is in interference fit with the inner wall of the outer pipe (3) or is fixed by heating.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201911021904.1A CN112704802A (en) | 2019-10-25 | 2019-10-25 | Balloon dilatation catheter and preparation method thereof |
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| CN201911021904.1A CN112704802A (en) | 2019-10-25 | 2019-10-25 | Balloon dilatation catheter and preparation method thereof |
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| CN112704802A true CN112704802A (en) | 2021-04-27 |
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| CN201911021904.1A Pending CN112704802A (en) | 2019-10-25 | 2019-10-25 | Balloon dilatation catheter and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113288335A (en) * | 2021-06-24 | 2021-08-24 | 苏州中荟医疗科技有限公司 | Shock wave guide tube and shock wave generation system |
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|---|---|---|---|---|
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| EP0580845A1 (en) * | 1992-02-10 | 1994-02-02 | Scimed Life Systems, Inc. | Intravascular catheter with distal guide wire lumen |
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| CN113288335A (en) * | 2021-06-24 | 2021-08-24 | 苏州中荟医疗科技有限公司 | Shock wave guide tube and shock wave generation system |
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Application publication date: 20210427 |