CN108211093A - Sacculus and foley's tube - Google Patents

Sacculus and foley's tube Download PDF

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Publication number
CN108211093A
CN108211093A CN201611156003.XA CN201611156003A CN108211093A CN 108211093 A CN108211093 A CN 108211093A CN 201611156003 A CN201611156003 A CN 201611156003A CN 108211093 A CN108211093 A CN 108211093A
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CN
China
Prior art keywords
sacculus
lines
stent
proximal end
fixed
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CN201611156003.XA
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Chinese (zh)
Inventor
龙汉
丘信炯
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Biotyx Medical Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Priority to CN201611156003.XA priority Critical patent/CN108211093A/en
Publication of CN108211093A publication Critical patent/CN108211093A/en
Pending legal-status Critical Current

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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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C55/00—Shaping by stretching, e.g. drawing through a die; Apparatus therefor
    • B29C55/22—Shaping by stretching, e.g. drawing through a die; Apparatus therefor of tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C59/00—Surface shaping of articles, e.g. embossing; Apparatus therefor
    • B29C59/02—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing
    • B29C59/021—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing of profiled articles, e.g. hollow or tubular articles, beams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
    • B29C69/02—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore of moulding techniques only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61M2025/006—Catheters; Hollow probes characterised by structural features having a special surface topography or special surface properties, e.g. roughened or knurled surface
    • 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
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters
    • B29L2031/7543—Balloon catheters

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Mechanical Engineering (AREA)
  • Child & Adolescent Psychology (AREA)
  • Manufacturing & Machinery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The present invention relates to a kind of sacculus, and including close end, distal portion and the middle part for bearing support, the middle part is set between the close end and the distal portion, and the surface of the middle part has coarse structure.The invention further relates to a kind of foley's tubes, including inner tube, the sacculus, developing ring, far ultraviolet pipe, hypotube and catheter block, the developing ring pressure is held in embedded said inner tube, the distal end of said inner tube is fixed in the distal portion of the sacculus, the distal end of the far ultraviolet pipe is fixed in the proximal end of the sacculus, the distal end of the hypotube is fixed in the proximal end of the far ultraviolet pipe, and the proximal end of the hypotube is fixed in catheter block.The present invention is used in the middle part of sacculus has textured coarse structure, significantly improves the removal force after sacculus is matched with stent, stent is prevented to be displaced or come off in transmission process.

Description

Sacculus and foley's tube
Technical field
The present invention relates to the field of medical instrument technology, more particularly to a kind of sacculus and foley's tube.
Background technology
Coronary heart disease is one of most common heart disease, refers to the myocardium machine because of caused by coronary artery stenosis, blood supply insufficiency Energy obstacle or organic disease, therefore also known as ischemic cardiomyopathy.At present, coronary heart disease mainly has drug therapy, is situated between through bellows blood vessel Enter three kinds of therapeutic schemes for the treatment of and heart surgical department bypass surgery.It, can be rapid through bellows vascular interventional treatment because its wound is small, it is fast to restore The features such as eliminating coronary artery stenosis, alleviating myocardial ischemia, it has also become the essential therapeutic arsenals of coronary heart disease.
Coronary Artery Disease Intervention Treatment is via bare ball capsule, bare metal stent, three developing stage of drug stent.It is controlled using stent Treat coronary heart disease when, stent is usually pressed into or is embedded in advance balloon surface, and be expected that by it is this cooperation make stent by curved Before bent complicated vascular access reaches target position, remain to be maintained on sacculus without shifting or coming off.It but should in clinic It is about 0.2-0.5% since stent the incidence that stent comes off not enough occurs in the adhesive force of balloon surface in.Stent comes off If dealt with improperly, easily there is acute myocardial infarction AMI, lead to death.Stent not enough also can in the adhesive force of balloon surface Cause stent-expansion incomplete.The high spot reviews that solving the removal force between stent and sacculus has become in stent balloon design refer to Mark.
Invention content
Based on this, it is necessary to provide a kind of sacculus and foley's tube to improve ball and expand adhesive force of the stent in balloon surface.
The present invention solves above-mentioned technical problem by following technical solution：
A kind of sacculus, including close end, distal portion and the middle part for bearing support, the middle part is set to described Between close end and the distal portion, the surface of the middle part has coarse structure.The surface of sacculus middle part has coarse Structure can significantly increase sacculus and be combined frictional force with the surface of stent, stent is prevented to be displaced or take off in transmission process It falls.
In one embodiment, the coarse structure is has textured coarse structure.Lines is set, can be further enhanced Sacculus is combined frictional force with the surface of stent, reduces stent and the possibility carried is taken off in transmission process.
In one embodiment, the lines is at least one of strip lines, reticulate pattern lines or point shape lines.
In one embodiment, the spacing of the lines is 0.5-5 microns.If lines is smaller than 0.5 micron or micro- more than 5 Rice may all prop up the stent that is unable to hold out.
In one embodiment, the roughness of the coarse structure is 0.1-0.8.In this roughness range, sacculus with It is most strong that the surface of stent combines frictional force.
In one embodiment, the material of the sacculus for nylon 11, nylon 12, PBEAX7233, PEBAX 7033, At least one in PEBAX6333, PEBAX5533, polyurethane (PU), polyphenyl dioctyl phthalate ethylene glycol fat (PET) or polyethylene (PE) Kind.
In one embodiment, the sacculus is individual layer or double-layered balloon.
In one embodiment, the thickness of the sacculus is 0.005-0.1mm.
The present invention also provides a kind of foley's tube, including inner tube, the sacculus, developing ring, far ultraviolet pipe, hypotube and conduit Seat, the developing ring pressure are held in embedded said inner tube, and the distal end of said inner tube is fixed in the distal portion of the sacculus, described remote The distal end of outer tube is fixed in the proximal end of the sacculus, and the distal end of the hypotube is fixed in the proximal end of the far ultraviolet pipe, institute The proximal end for stating hypotube is fixed in catheter block.
In one embodiment, the fixation is realized by laser welding or air-heater welding.
In one embodiment, the hypotube is adhesively fixed proximally by glue in catheter block.
In one embodiment, stent is held by pressure on the sacculus for being pressed on deflated folded state.
In one embodiment, the production method of the sacculus, includes the following steps：
(1) sacculus molding die is made, the sacculus molding die is remote by balloon proximal end mould, sacculus intermediate die and sacculus End mould composition is held, the inner surface of the sacculus intermediate die has identical roughness with the surface of the sacculus middle part.
(2) sacculus expects pipe is subjected to pre-stretching processing, expects pipe both ends draw and attenuate, with can be by balloon proximal end mould and remote End mould is held, the 1/4-1 times of length that centre retains length of balloon is not stretch section, as final sacculus profiled section.
(3) balloon forming machine of sacculus molding die has been installed in the sacculus expects pipe insertion that step (2) has been completed to pre-stretching It is interior, briquetting pressure 20-40bar, 85-110 DEG C of forming temperature, 120-140 DEG C of heat setting temperature, heat-setting time 30-90s.
Roughness (Ra) described in step (1) is 0.1-0.8.
The present invention, using having textured coarse structure, significantly enhances sacculus and stent on the surface of sacculus middle part The combination frictional force on surface, prevents stent to be displaced or come off in transmission process, effectively increases sacculus and is matched with stent Removal force afterwards.
Description of the drawings
Below in conjunction with accompanying drawings and embodiments, the invention will be further described, in attached drawing：
Fig. 1 is the structure diagram of the stent delivery system of embodiment 1；
Fig. 2 is balloon-stent assembling schematic diagram；
Fig. 3 is the structure diagram of the sacculus of embodiment 1；
Fig. 4 is the surface roughness schematic diagram of the sacculus of embodiment 1；
Fig. 5 is the surface roughness schematic diagram of the sacculus of embodiment 2；
Fig. 6 is the surface roughness schematic diagram of the sacculus of embodiment 3；
Fig. 7 is the surface roughness schematic diagram of the sacculus of embodiment 4；
Fig. 8 is the sacculus mould assembling schematic diagram of embodiment 1；
Fig. 9 is the atomic force microscopy diagram on the surface of commercially available sacculus；
Figure 10 is the atomic force microscopy diagram on the surface of the sacculus of embodiment 1；
Figure 11 is the sacculus of the present invention and control group sacculus (commercially available) removal force test result figure.
Specific embodiment
For a clearer understanding of the technical characteristics, objects and effects of the present invention, it is described in detail in conjunction with attached drawing The specific embodiment of the present invention.
Unless otherwise defined, all of technologies and scientific terms used here by the article belongs to the skill of the technical field of the present invention The normally understood meaning of art personnel is identical.Used term is intended merely to description specific embodiment in the description herein Purpose, it is not intended that in the limitation present invention.
Embodiment 1
As shown in figure 3, a kind of individual layer sacculus 102, including close end 1023, distal portion 1022 and in bearing support Between portion 1021, middle part 1021 is set between close end 1023 and distal portion 1022, and the surface of middle part 1021 has coarse Structure.The surface of sacculus middle part has coarse structure, can significantly increase sacculus and be combined frictional force with the surface of stent, prevent from propping up Frame is displaced or comes off in transmission process.
The material of sacculus 102 is nylon 12 (Grilamid L25), and balloon diameter 3.0mm, length 15mm, thickness is 0.005-0.1mm.The surface roughness Ra of sacculus middle part 1021 is 0.5, and surface roughness is as shown in figure 4, its lines For reticulate pattern lines, the lines intersected including two groups, every group of lines includes a plurality of linear type net mosquito being mutually parallel, adjacent two nets The spacing of line is 0.5-5 microns.
As shown in Figure 1, a kind of foley's tube, including inner tube 101, the sacculus 102, developing ring 104, far ultraviolet pipe 105, sea Wave duct 106 and catheter block 107, the pressure of developing ring 104 are held in embedded inner tube 101, and the distal end of inner tube 101 passes through laser welding or hot wind Machine welding is fixed in the distal portion of sacculus 102, and ball is fixed in the distal end of far ultraviolet pipe 105 by laser welding or air-heater welding In the proximal end of capsule 102, the distal end of hypotube 106 is fixed on by laser welding or air-heater welding in the proximal end of far ultraviolet pipe 105, Hypotube 106 is adhesively fixed proximally by glue in catheter block 107.Stent 103 is held by pressure and is pressed on deflated rugosity On the middle part 1021 of the sacculus 102 of state.
The production method of sacculus 102 includes the following steps：
(1) expects pipe is pre-stretched：Using both-end stretching-machine (CPS1000, Interface), 150 DEG C of draft temperature, stretch away from From 90mm, tensile speed 200mm/s, heating time 5s, cooling time 2s, non-stretched distance 20mm；After mother tube is stretched, not Stretch section is using main body when being molded as sacculus.
(2) molding die makes：The sacculus mould of the present embodiment is the mold with micron-sized surface roughness, is formed Similar frosted finish effect.Sacculus mould assembling schematic diagram is as shown in figure 8, by sacculus intermediate die 202, balloon proximal end mould 201 and ball Capsule distal end mould 204 forms, and balloon proximal end mould 201 and balloon distal end mould 204 are nested in sacculus by the gap of 0.1-1mm In intermediate die 202.(it is Ra0.02- to be different from general sacculus product mold to surface roughness of the sacculus intermediate die with Ra0.5 0.05 mirror effect), and balloon proximal end mould and balloon distal end mould are still maintained as minute surface, because it does not generate dress with stent With relationship.
(3) sacculus is molded：Use balloon forming machine (BFM3310, Interface), 105 DEG C of forming temperature, briquetting pressure 36bar, 140 DEG C of heat setting temperature, heat-setting time 60s；The surface roughness that can obtain middle part after molding is Ra0.5's Sacculus.
Embodiment 2
The structure of the present embodiment individual layer sacculus as the sacculus of embodiment 1, difference lies in：The material of individual layer sacculus is PEBAX7233SA01 (ARKEMA), balloon diameter 3.0mm, length 15mm, thickness 0.005-0.1mm.Sacculus middle part 1021 Surface roughness Ra for 0.3, for surface roughness as shown in figure 5, its lines is reticulate pattern lines, the spacing of lines is 0.5- 5 microns.
The production method of sacculus includes the following steps：
(1) expects pipe is pre-stretched：Using both-end stretching-machine (CPS1000, Interface), 145 DEG C of draft temperature, stretch away from From 110mm, tensile speed 200mm/s, heating time 5s, cooling time 2s, non-stretched distance 20mm.After mother tube is stretched, Non-stretched section using main body when being molded as sacculus.
(2) molding die makes：The sacculus mould of the present embodiment is the mold with micron-sized surface roughness, is formed Similar frosted finish effect.Sacculus mould assembling schematic diagram is as shown in figure 8, by sacculus intermediate die 202, balloon proximal end mould 201 and ball Capsule distal end mould 204 forms, and balloon proximal end mould 201 and balloon distal end mould 204 are nested in sacculus by the gap of 0.1-1mm In intermediate die 202.(it is Ra0.02- to be different from general sacculus product mold to surface roughness of the sacculus intermediate die with Ra0.3 0.05 mirror effect), and balloon proximal end mould and balloon distal end mould are still maintained as minute surface, because it does not generate dress with stent With relationship.
(3) sacculus is molded：Use balloon forming machine (BFM3310, Interface), 100 DEG C of forming temperature, briquetting pressure 34bar, 135 DEG C of heat setting temperature, heat-setting time 60s.The surface roughness that can obtain middle part after molding is Ra0.3's Sacculus.
Embodiment 3
The structure of the present embodiment individual layer sacculus as the sacculus of embodiment 1, difference lies in：The material of individual layer sacculus is PEBAX7033SA01 (ARKEMA), balloon diameter 3.0mm, length 15mm, thickness 0.005-0.1mm.Sacculus middle part 1021 Surface roughness Ra for 0.15, as shown in fig. 6, its lines is point shape lines, the spacing of lines is surface roughness 0.5-5 microns.
The production method of sacculus includes the following steps：
(1) expects pipe is pre-stretched：Using both-end stretching-machine (CPS1000, Interface), 140 DEG C of draft temperature, stretch away from From 110mm, tensile speed 200mm/s, heating time 5s, cooling time 2s, non-stretched distance 20mm.After mother tube is stretched, Non-stretched section using main body when being molded as sacculus.
(2) molding die makes：The sacculus mould of the present embodiment is the mold with micron-sized surface roughness, is formed Similar frosted finish effect.Sacculus mould assembling schematic diagram is as shown in figure 8, by sacculus intermediate die 202, balloon proximal end mould 201 and ball Capsule distal end mould 204 forms, and balloon proximal end mould 201 and balloon distal end mould 204 are nested in sacculus by the gap of 0.1-1mm In intermediate die 202.(it is Ra0.02- to be different from general sacculus product mold to surface roughness of the sacculus intermediate die with Ra0.15 0.05 mirror effect), and balloon proximal end mould and balloon distal end mould are still maintained as minute surface, because it does not generate dress with stent With relationship.
(3) sacculus is molded：Use balloon forming machine (BFM3310, Interface), 95 DEG C of forming temperature, briquetting pressure 34bar, 130 DEG C of heat setting temperature, heat-setting time 60s.The surface roughness that can obtain middle part after molding is Ra0.15 Sacculus.
Embodiment 4
The structure of the present embodiment individual layer sacculus as the sacculus of embodiment 1, difference lies in：The material of individual layer sacculus is by weight Measure very 30% nylon 12 (Grilamid L25) and 70%PEBAX7033SA01 (ARKEMA) mixing compositions, balloon diameter 3.0mm, length 15mm, thickness 0.005-0.1mm.The surface roughness Ra of sacculus middle part 1021 is 0.8, rough surface For structure as shown in fig. 7, its lines is strip lines, the spacing of lines is 0.5-5 microns.
The production method of sacculus includes the following steps：
(1) expects pipe is pre-stretched：Using both-end stretching-machine (CPS1000, Interface), 140 DEG C of draft temperature, stretch away from From 110mm, tensile speed 200mm/s, heating time 5s, cooling time 2s, non-stretched distance 20mm.After mother tube is stretched, Non-stretched section using main body when being molded as sacculus.
(2) molding die makes：The sacculus mould of the present embodiment is the mold with micron-sized surface roughness, is formed Similar frosted finish effect.Sacculus mould assembling schematic diagram is as shown in figure 8, by sacculus intermediate die 202, balloon proximal end mould 201 and ball Capsule distal end mould 204 forms, and balloon proximal end mould 201 and balloon distal end mould 204 are nested in sacculus by the gap of 0.1-1mm In intermediate die 202.(it is Ra0.02- to be different from general sacculus product mold to surface roughness of the sacculus intermediate die with Ra0.8 0.05 mirror effect), and balloon proximal end mould and balloon distal end mould are still maintained as minute surface, because it does not generate dress with stent With relationship.
(3) sacculus is molded：Use balloon forming machine (BFM3310, Interface), 95 DEG C of forming temperature, briquetting pressure 34bar, 130 DEG C of heat setting temperature, heat-setting time 60s.The surface roughness that can obtain middle part after molding is Ra0.8's Sacculus.
Effect example
In order to illustrate further foley's tube prepared by the above-mentioned preparation method of the present invention, using in Examples 1 and 2 Product is compared with commercially available product, and Fig. 9 is atomic force microscope (AFM) figure of the untreated balloon surface of control group, Figure 10 is the atomic force microscopy diagram of the sacculus balloon surface of embodiment 1.It can be seen from the figure that the balloon surface phase of the present invention Surface than sacculus (commercially available) not surface treated under common process forms difference in microstructure, and surface roughness is bright It is aobvious to improve, it is confirmed through product test result (see Figure 11), the sacculus in the present invention has with the removal force after stent assembling significantly to be carried It rises, can effectively solve the problems, such as that stent takes off in clinical operation and carry.
The embodiment of the present invention is described above in conjunction with attached drawing, but the invention is not limited in above-mentioned specific Embodiment, above-mentioned specific embodiment is only schematical rather than restricted, those of ordinary skill in the art Under the enlightenment of the present invention, present inventive concept and scope of the claimed protection are not being departed from, can also made very much Form, these are belonged within the protection of the present invention.

Claims (9)

1. a kind of sacculus, including close end, distal portion and the middle part for bearing support, the middle part is set to described near Between end and the distal portion, which is characterized in that the surface of the middle part has coarse structure.
2. sacculus according to claim 1, which is characterized in that the coarse structure is has textured coarse structure.
3. sacculus according to claim 2, which is characterized in that the lines is strip lines, reticulate pattern lines or point shape At least one of lines.
4. the sacculus according to Claims 2 or 3, which is characterized in that the spacing of the lines is 0.5-5 microns.
5. sacculus according to claim 1, which is characterized in that the roughness of the coarse structure is 0.1-0.8.
6. sacculus according to claim 1, which is characterized in that the material of the sacculus for nylon 11, nylon 12, In PBEAX7233, PEBAX 7033, PEBAX6333, PEBAX5533, polyurethane, polyphenyl dioctyl phthalate ethylene glycol fat or polyethylene At least one.
7. sacculus according to claim 1, which is characterized in that the sacculus is individual layer or double-layered balloon.
8. sacculus according to claim 1, which is characterized in that the thickness of the sacculus is 0.005-0.1mm.
9. a kind of foley's tube, which is characterized in that including inner tube, the sacculus, developing ring, far ultraviolet pipe, hypotube and catheter block, The developing ring pressure is held in embedded said inner tube, and the distal end of said inner tube is fixed in the distal portion of the sacculus, the far ultraviolet The distal end of pipe is fixed in the proximal end of the sacculus, and the distal end of the hypotube is fixed in the proximal end of the far ultraviolet pipe, described The proximal end of hypotube is fixed in catheter block.
CN201611156003.XA 2016-12-14 2016-12-14 Sacculus and foley's tube Pending CN108211093A (en)

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CN108857294A (en) * 2018-09-14 2018-11-23 诸暨市碧涵精工模塑有限公司 A method of making grid line on bend pipe arc surface
CN109395232A (en) * 2018-11-26 2019-03-01 辽宁垠艺生物科技股份有限公司 The plastic bag of silk ribbon constraint
CN111202896A (en) * 2018-11-05 2020-05-29 上海微创心通医疗科技有限公司 Balloon dilatation catheter, balloon and preparation method thereof
CN112569455A (en) * 2020-12-09 2021-03-30 威高奋威健康科技发展(上海)有限公司 Stretching forming die and forming method for vertebral body expansion balloon
CN112704802A (en) * 2019-10-25 2021-04-27 河南驼人医疗器械集团有限公司 Balloon dilatation catheter and preparation method thereof
CN113208791A (en) * 2021-04-28 2021-08-06 聚辉医疗科技(深圳)有限公司 Conveyor and blood flow guiding bracket system
CN113427784A (en) * 2021-06-29 2021-09-24 伊索曼(中山)医疗器械有限公司 Manufacturing method of medical balloon surface bulge and medical balloon
CN114261080A (en) * 2021-12-16 2022-04-01 科睿驰（深圳）医疗科技发展有限公司 Balloon forming method
WO2023087185A1 (en) * 2021-11-17 2023-05-25 科塞尔医疗科技（苏州）有限公司 Balloon catheter assembly
CN116604810A (en) * 2023-05-25 2023-08-18 惠州市顺美医疗科技有限公司 Catheter sheath surface forming equipment and forming process thereof

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CN108857294A (en) * 2018-09-14 2018-11-23 诸暨市碧涵精工模塑有限公司 A method of making grid line on bend pipe arc surface
CN111202896A (en) * 2018-11-05 2020-05-29 上海微创心通医疗科技有限公司 Balloon dilatation catheter, balloon and preparation method thereof
CN109395232A (en) * 2018-11-26 2019-03-01 辽宁垠艺生物科技股份有限公司 The plastic bag of silk ribbon constraint
CN112704802A (en) * 2019-10-25 2021-04-27 河南驼人医疗器械集团有限公司 Balloon dilatation catheter and preparation method thereof
CN112569455A (en) * 2020-12-09 2021-03-30 威高奋威健康科技发展(上海)有限公司 Stretching forming die and forming method for vertebral body expansion balloon
CN113208791A (en) * 2021-04-28 2021-08-06 聚辉医疗科技(深圳)有限公司 Conveyor and blood flow guiding bracket system
CN113427784A (en) * 2021-06-29 2021-09-24 伊索曼(中山)医疗器械有限公司 Manufacturing method of medical balloon surface bulge and medical balloon
CN113427784B (en) * 2021-06-29 2022-09-13 伊索曼(中山)医疗器械有限公司 Manufacturing method of medical balloon surface bulge and medical balloon
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