CN106422032A - Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion - Google Patents
Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion Download PDFInfo
- Publication number
- CN106422032A CN106422032A CN201610859893.4A CN201610859893A CN106422032A CN 106422032 A CN106422032 A CN 106422032A CN 201610859893 A CN201610859893 A CN 201610859893A CN 106422032 A CN106422032 A CN 106422032A
- Authority
- CN
- China
- Prior art keywords
- outer tube
- sacculus
- cap
- inner tube
- seal wire
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
-
- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- 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
-
- 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
-
- 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
- A61M25/1034—Joining of shaft and balloon
-
- 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
- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1003—Spinal column
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Child & Adolescent Psychology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Manufacturing & Machinery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a balloon catheter for vertebral expansion and a preparation method of the balloon catheter for vertebral expansion. The preparation method includes steps: S10, performing injection moulding to obtain a Y-shaped catheter body and a catheter cap; S20, adhering a supporting guide wire and a guide wire cap; S30, preparing a balloon, marking an outer tube, enabling the balloon to sleeve one end of the outer tube, enabling a tube sleeve to sleeve the joint of the outer tube and the balloon, and firmly welding the tube sleeve; S40, connecting the outer tube with the Y-shaped catheter body; S50, connecting the inner tube with the catheter cap of the Y-shaped catheter body; S60, mounting radiopaque marks on the inner tube; S70, connecting the Y-shaped catheter body with the catheter cap; S80, sealing a far end of the balloon; S90, inserting the supporting guide wire into the inner tube, mounting a needleless connector at a third connection port, and evacuating the balloon to finish assembly. Due to synchronous execution of multiple procedures, production efficiency is improved.
Description
Technical field
The present invention relates to Design for Medical Device and its preparation technology field, espespecially a kind of balloon catheter for expanding vertebra and its system
Preparation Method.
Background technology
Vertebral fracture can cause the dysfunction pain of periods of months, and this pain can make patient disability
And motor capacity, can promptly cause forfeiture, pulmonary atelectasis and pneumonia, the formation of deep venous thrombosis and the pulmonary infarction of limb function
Etc. fatal complication, compression fracture of vertabral body was also that a lot of life of elderly person can not be taken care of oneself and be lost independent living ability in the past
The reason for.Using substantial amounts of Drug therapy, usually cause poisonous side effect of medicine and drug dependence, patient does not receive or not mostly
It is resistant to surgical operation therapy.Mainly there are two kinds of operation means at present for the disease.
One be vertebroplasty clinic full name be percutaneous vertebroplasty (percutaneous vertebro
Plasty, PVP), belong to Minimally Invasive Surgery, by doing the otch of an about 2mm at patient back, supervised in x-ray with special puncture needle
Vertebral body is entered through skin penetrating under shield, service aisle is set up, stable fracture vertebral body in bone cement or artificial bone injection vertebral body prevents
Only subside further, hence it is evident that alleviating pain.Two be percutaneous kyphoplasty (percutanouskyphoplasty,
PKP), it is to first pass around after balloon expandable obtains vertebral body cavity to inject bone cement by several times again, stays after one side balloon expandable
Spongy bone around cavity is compacted, and has artificially manufactured the barrier of a prevention bone cement seepage；On the other hand push rod is used
By several times the more traditional compression pump of injection bone cement persistently injects pressure when greatly reducing bone cement injection, therefore bone cement
Seepage greatly reduces.This has percutaneous kyphoplasty (percutanouskyphoplasty, PKP) to have possessed relatively
Good application prospect.And the patent documentation of Publication No. CN2905092Y discloses a kind of vertebral body expanding balloon for PKP and leads
Pipe, including a balloon-expandable, also include soft outer catheter, be placed in soft hollow inner catheter in outer catheter, be placed in
Tool in conduit is resilient to support seal wire and Y type connection member；One branch of Y type connection member and outer catheter, interior lead
Pipe and balloon-expandable constitute a closed channel.
Percutaneous kyphoplasty (percutanouskyphoplasty, PKP) has following two in the application
Individual problem：
1st, the operation of percutaneous kyphoplasty to complete from percutaneous puncture, sacculus pressurizing and propping fractured vertebral body,
The complexity such as sacculus, continuous work process is withdrawn from, as the complexity of its operating process and medical apparatus and instruments itself are for equipment
Fine degree requirement so that balloon catheter for expanding vertebra mechanism structure used in operation is complex fine, its processing
Technology is very crucial.But so far, with regard to the document of percutaneous kyphoplasty, it is description vertebral body augmentation ball mostly
The concrete structure of ductus bursae, the structural style of sacculus, rarely have document to be disclosed the preparation side of the structure of balloon catheter for expanding vertebra
Method.
2nd, inside vertebral fracture, the relative pressure that after fracture, the vertebral body of rupture is formed to sacculus is less or uneven, ball
Capsule will select place expansion less to pressure in pressurized expansion process, thus very likely increase to crush the bone at position
Folding degree of injury, or even cause refracture, so as to making patients' state of an illness, this is for dimension and the tightness proposition of sacculus
Higher requirement；Additionally, sacculus is split-type structural with the pipe fitting of balloon catheter for expanding vertebra structure, and sacculus is work shape
The pressure containing part of certain pressure is undertaken under state.Based on above-mentioned situation, the integrity problem that sacculus is connected with main pipe body is urgently to be resolved hurrily.
Content of the invention
It is an object of the invention to provide a kind of balloon catheter for expanding vertebra structure, the reliability for realizing sacculus with main pipe body connects
Connect.
The technical scheme that the present invention is provided is as follows：A kind of balloon catheter for expanding vertebra structure, including sacculus, outer tube, inner tube,
Support seal wire, seal wire cap, radiopaque labelling and Y-connector.
The Y-connector includes Y-piece body, needleless joint and pipe cap；The Y-piece body includes line part and from described
The sidepiece of straight line portion expenditure, the two ends of the line part are respectively arranged with first interface and second interface, and the sidepiece is overhanging
One end is provided with the 3rd interface, and the first interface closes on the junction of the line part and the sidepiece；The pipe cap is arranged
In the second interface, the needleless joint is arranged on the 3rd interface.
Side channels are provided with the sidepiece, and the first end of the outer tube is connected with the side channels, described outer
The second end of pipe is turned on the balloon interior；The balloon proximal is welded and fixed by pipe box with the outer tube.
Said inner tube is worn along the outer tube, and one end of said inner tube is extended down to institute outside the first end by the outer tube
State pipe cap, the other end of said inner tube extends through the balloon interior outside the second end of the outer tube, the sacculus remote
End is welded and fixed by pipe box with said inner tube；Described pipe box can be the material such as silica gel or PTFE, and the pipe cap is provided with
The passage of insertion, the pipe cap is adhesively fixed by the glue in the passage with said inner tube；
The support seal wire is placed in said inner tube through the pipe cap, and described support seal wire one end is provided with seal wire
Cap, the seal wire cap is detachably connected with the pipe cap；In the middle part of the seal wire cap, insertion is provided with and places the seal wire for supporting seal wire
Hole, the seal wire cap is adhesively fixed by the glue in the thread eye with the support seal wire；
The radiopaque labelling is arranged at the inner catheter in the sacculus, and two are arranged side by side, and concrete material is permissible
Make of metal materials such as 304 stainless steel tubes, platinum pipe, tantalum capillary tubies；The needleless joint is embedded with silica gel plug.
The two ends of the sacculus are welded and fixed with inner tube and outer tube by the pipe box for adding respectively, weld this by hot solvent
One version ensures stable connection under working condition first, and can prevent sacculus excessively expansion from causing fracture；In addition, logical
Silica gel material is crossed as binding agent, can just optimize under room temperature environment, simplification operation is cost-effective, and silica gel material is hard
The rubber performance of tool elastic force occurs after change, has adapted to the operative scenario of balloon catheter for expanding vertebra structure.
Seal wire side is supported to add the seal wire cap that can be detachably connected with pipe cap, conveniently operation and carrying；On the other hand, lead
Silk cap is adhesively fixed by the glue in the thread eye of insertion with seal wire, and type of attachment is stable, using the design of the thread eye of insertion
Conveniently carry out plus glue and the operation that subsequently dries.
The invention also discloses a kind of preparation method of balloon catheter for expanding vertebra structure, comprises the following steps：
S10, Y-piece body and pipe cap described in injection mo(u)lding；
S20, bond the support seal wire and the seal wire cap；
S30, prepares the sacculus, and identifies the outer tube, and the sacculus is set in outer tube one end, and by a pipe box set
It is located at the outer tube and the sacculus junction, the welding fastening pipe box；
S40, after completing step S10 and step S30, connects the outer tube and the Y-piece body；
S50, connects the pipe cap of said inner tube and the Y-piece body；
S60, after completing step S50, installs radiopaque labelling in said inner tube；
S70, after completing step S40 and step S60, connects the Y-piece body and the pipe cap；
S80, after completing step S70, pipe box is set in the joint of said inner tube and the balloon distal, and is welded
Fastening is connect, the distal end of the sacculus is sealed；
S90, after completing step S20 and step S80, the support seal wire is inserted in said inner tube, will be no
Needle adapter is arranged on the 3rd seam, evacuates the sacculus using compression pump by the 3rd interface, makes balloon expandable
Segment outer radius diminish as 2-4mm and complete assembling.
Need any is described, the symbol of S10 to S90 is arranged, and does not mean that preparation process according to numeral from small to large
Carry out successively, simply a kind of setting of identification for convenience of description, the step of concrete preparation method successively on order, with text
Word narration is named being defined of successively carrying out, and also refers to Fig. 5.
Y-connector includes the pipe cap with Y-connector split and main structural frame Y-piece body, adds actual
Two structures being based respectively on during work be prepared, on the one hand tightens solid sacculus in outer tube, then will be outer for the connection of Y-piece body
Pipe, on the other hand connection inner tube and pipe cap, then arrange radiopaque labelling on inner pipe, after the completion of by Y-piece body and with outer
The pipe cap connection of pipe connection, followed by completing follow-up preparation section.So process step design, simplifies operating procedure, multigroup
Operation synchronously can be carried out, the production efficiency of quickening, and operation is specifically controlled, it is easy to standardization, can preferably control per
Quality after the completion of one step.
Preferably, step S20 includes following operation：
First, it is transferred in syringe cylinder after glue is thoroughly mixed；
Second, seal wire being supported through the through hole of the seal wire cap by described, and places vertically downward；
3rd, filled up with glue in the through hole of the seal wire cap with the syringe cylinder, keep the seal wire cap upwards
State, wait the glue solidifies.
Seal wire being placed in the seal wire cap of insertion then carries out glue and is adhesively fixed, can be from the heteropleural potting compound of seal wire insertion
Water, simple operation is convenient, and encapsulating is abundant, is also beneficial to subsequently wait the process that the glue solidifies quickly to carry out.
Preferably, in step S30, the operation of the welding fastening pipe box includes following operation：
First, the first mandrel with alcohol wipe outer tube and for supporting outer tube；
Second, first mandrel is inserted in the outer tube, pipe box is enclosed within the combination of the outer tube and the sacculus
Place, it is desirable to which one end of the pipe box is substantially flush with one end of the outer tube；
3rd, pipe box is placed on bonding machine station, welding makes pipe box be fastenedly connected with the outer tube and the sacculus.
Being welded and fixed proximally by the pipe box for adding and outer tube for the sacculus, welds this version by binding agent
Ensure stable connection under working condition first, and sacculus excessively expansion can be placed to cause fracture；In addition, passing through silica gel material
As binding agent, can just optimize under room temperature environment, simplification operation is cost-effective, and silica gel material occurs after curing
The rubber performance of tool elastic force, has adapted to the operative scenario of balloon catheter for expanding vertebra structure.
Preferably, step S40 includes following operation：
First, heat-shrinkable tube is inserted in the outer tube, with fixture, the heat-shrinkable tube is fixed on and closes at the sacculus；
Second, glue is uniformly coated in one end of the outer tube no sacculus, will then coat the outer tube of glue along
First mandrel inserts the first interface of the Y-piece body；
3rd, keep outer tube to have one end of sacculus state upwards, until dried；
4th, the fixture to be removed, the movement heat-shrinkable tube is received to the outer tube and the Y-piece body junction
Contract the heat-shrinkable tube.
Outer tube is fastenedly connected by glue first with Y-piece body, reuses heat-shrinkable tube contraction and fasten after the glue solidifies, and one
Aspect is by one rigidized cover of glue fastening part peripheral hardware so that outer tube is higher with the connection reliability of Y-piece body；On the other hand, by
It is flexible piece in outer tube, Y-piece body one end is close to, total can be strengthened by heat-shrinkable tube fastening this section of intensity of increase
Stability.
Preferably, step S50 includes following operation：
Second mandrel is inserted said inner tube；Glue is uniformly coated in the frosted end of said inner tube, then will
Said inner tube is in second mandrel insertion pipe cap, and rocking makes glue penetrate into uniformly；The glue solidifies for wait.
Frosted section is processed as by said inner tube to be close to one end of pipe cap, increases this section bonding with the glue of pipe cap strong
Degree.
Preferably, step S60 includes following operation：
First, two radiopaque labellings are inserted in along inner tube one end；
Second, the said inner tube with the pipe cap is sequentially passed through line part and the outer tube of the Y-piece body；The pipe
Cap and the Y-piece body are detachably connected closing on to coordinate at the second interface, and two radiopaque labellings are located at institute
State in sacculus.
Before Y-piece body is connected with pipe cap, radiopaque labelling is set on inner pipe, inner tube can be plugged into outer tube
Whether the position of observation radiopaque labelling is appropriate afterwards, is then adjusted.So operation is arranged and can ensure that radiopaque
The position of labelling is placed on optimum position.
Preferably, step S70 includes following operation：
First, second mandrel is inserted said inner tube；Said inner tube with the pipe cap sequentially passes through the Y type
The line part of body and outer tube, the pipe cap keeps certain distance with the Y-piece body；
Second, glue is injected to the Y-connector second interface, the pipe cap is inserted the Y-piece body second interface
In, slowly rotate to locking；
3rd, maintain sacculus end state upwards, until dried.
Preferably, step S80 includes following operation：
First, second mandrel is inserted said inner tube, extends to the radiopaque mark；The then ball again
The sheathed pipe box in capsule distal end, the pipe box is not contacted with the balloon expandable part；
Second, weld the coupling part of the pipe box and the sacculus；Heating welding is carried out to being cased with collar portion, until
Weld；
3rd, the balloon distal after welding and the coupling part of said inner tube are cut, is expanded in balloon distal
Part outwards retains the horizontal segment of 0.5-5mm.
The distal end of the sacculus is welded and fixed with inner tube by the pipe box for adding, and welds this version by binding agent
Ensure stable connection under working condition first, and sacculus excessively expansion can be placed to cause fracture；Secondly, by silica gel material
As binding agent, can just optimize under room temperature environment, simplification operation is cost-effective, and silica gel material occurs after curing
The rubber performance of tool elastic force, has adapted to the operative scenario of balloon catheter for expanding vertebra structure.
The preparation method of the balloon catheter for expanding vertebra structure for being provided by the present invention, can bring following at least one to have
Beneficial effect：
1st, being based respectively on pipe cap and Y-piece body is processed, on the one hand solid sacculus is tightened in outer tube, then by Y-piece
On the other hand body connects outer tube, connection inner tube and pipe cap, then arranges radiopaque labelling on inner pipe, after the completion of by Y-piece
Body and the pipe cap connection being connected with outer tube, followed by completing follow-up preparation section.So process step design, simplifies operation step
Suddenly；Multigroup operation synchronously can be carried out, the production efficiency of quickening；Operation is specifically controlled, it is easy to standardization, can more preferable control
Quality after the completion of each step.
2nd, the sacculus is welded and fixed with inner and outer pipe respectively by the pipe box for adding, and welds this structure by binding agent
Form ensures stable connection under working condition first, and can place sacculus excessively expansion and cause fracture；In addition, passing through silica gel
Material can just optimize under room temperature environment as binding agent, and simplification operation is cost-effective, and silica gel material after curing can
There is the rubber performance of tool elastic force, adapted to the operative scenario of balloon catheter for expanding vertebra structure.
Glue is then carried out in the seal wire cap that the 3rd, seal wire is placed in insertion to be adhesively fixed, can be from the heteropleural perfusion of seal wire insertion
Glue, simple operation is convenient, and encapsulating is abundant, is also beneficial to subsequently wait the process that the glue solidifies quickly to carry out.
4th, inner and outer pipe and Y-piece body are fastenedly connected by glue first, reuse heat-shrinkable tube and shrink tightly after the glue solidifies
Gu, on the one hand by one rigidized cover of glue fastening part peripheral hardware so that outer tube is higher with the connection reliability of Y-piece body；The opposing party
Face, as outer tube is flexible piece, can be strengthened entirely by heat-shrinkable tube fastening this section of intensity of increase Y-piece body one end is close to
The stability of structure.
5th, before Y-piece body is connected with pipe cap, radiopaque labelling is set on inner pipe, inner tube can be plugged into outer
Whether the position for observing radiopaque labelling after pipe is appropriate, is then adjusted.So operation is arranged and can ensure that not transmission
The position of wire tag is placed on optimum position.
Description of the drawings
Below by the way of clearly understandable, preferred implementation be described with reference to the drawings, a kind of vertebral body expanding balloon is led
The above-mentioned characteristic of tubular construction, technical characteristic, advantage and its implementation are further described.
Fig. 1 is balloon catheter for expanding vertebra structural representation.
Fig. 2 is sacculus peripheral structure schematic diagram
Fig. 3 is the annexation schematic diagram of Y-piece body and other structures.
Fig. 4 is the structural representation for supporting seal wire.
The preparation method general flow chart of Tu5Shi balloon catheter for expanding vertebra mechanism.
Drawing reference numeral explanation：1st, Y-connector, 2, sacculus, 3, outer tube, 4, inner tube, 5, support seal wire, 6, seal wire cap, 7,
Radiopaque labelling, 8, Y-piece body, 9, needleless joint, 10, pipe cap, 11, first interface, 12, second interface, the 13, the 3rd connects
Mouthful, 14, line part, 15, sidepiece, 16, outer tube first end, 17, outer tube the second end, 18, inner tube first end, 19, inner tube
The second end, 20, balloon distal, 21, balloon proximal.
Specific embodiment
In order to be illustrated more clearly that the embodiment of the present invention or technical scheme of the prior art, below by control description of the drawings
The specific embodiment of the present invention.It should be evident that drawings in the following description are only some embodiments of the present invention, for
For those of ordinary skill in the art, on the premise of not paying creative work, other can also be obtained according to these accompanying drawings
Accompanying drawing, and obtain other embodiments.
For making simplified form, each in figure only schematically show part related to the present invention, and they do not represent
Which is used as the practical structures of product.In addition, so that simplified form is readily appreciated, there is identical structure or function in some in figures
Part, only symbolically depicts one of those, or has only marked one of those.Herein, " one " not only represents
" only this ", it is also possible to represent the situation of " more than one ".
Herein, the restriction on the mathematics and/or geometry meaning of " vertical " etc. non-critical, also includes this area skill
Art personnel may be appreciated and manufacture or use etc. the error of permission.
As shown in Figure 1, Figure 2, Figure 3 shows, embodiment of the invention discloses that a kind of balloon catheter for expanding vertebra structure, including ball
Capsule 2, outer tube 3, inner tube 4, support seal wire 5, seal wire cap 6, radiopaque labelling 7 and Y-connector 1.
Y-connector 1 includes Y-piece body 8, needleless joint 9 and pipe cap 10；Y-piece body 8 includes line part 14 and from straight line
The sidepiece 15 that portion 14 branches out, the two ends of line part 14 are respectively arranged with first interface 11 and second interface 12, and sidepiece 15 is overhanging
One end is provided with the 3rd interface 13, and first interface 11 closes on the junction of line part 14 and sidepiece 15；Pipe cap 10 is arranged on second
On interface 12, needleless joint 9 is arranged on the 3rd interface 13.
15 conduit of sidepiece is provided with sidepiece 15, outer tube first end 16 is connected with 15 conduit of sidepiece, outer tube the second end
17 are turned on 2 inside of sacculus；Balloon proximal 21 is welded and fixed by pipe box with outer tube 3.
Inner tube 4 is worn inside outer tube 3, and inner tube first end 16 is extended down to pipe cap 10, inner tube by outer tube first end 16 outward
The second end 19 is extended through inside sacculus 2 outside outer tube the second end 17, and balloon distal 20 is solid by pipe box welding with inner tube 4
Fixed；Pipe cap 10 is provided with the passage of insertion, and pipe cap 10 is adhesively fixed by the glue in passage with inner tube 4.
Seal wire 5 is supported to be placed in inner tube 4 through pipe cap 10, as shown in figure 4, supporting 5 one end of seal wire to be provided with seal wire cap
6, seal wire cap 6 is detachably connected with pipe cap 10；The 6 middle part insertion of seal wire cap is provided with places the thread eye for supporting seal wire 5, seal wire cap
6 are adhesively fixed by the glue in thread eye with seal wire 5 is supported.
Exemplary, the radiopaque labelling 7 of the present embodiment is arranged at the inner catheter in sacculus 2, be two simultaneously
The platinum ring that arrangement is put；Needleless joint 9 is embedded with silica gel plug, and the middle part of silica gel plug has been axially formed normally closed silica gel passage；
Involved pipe box is silica gel pipe box.Of course, in other embodiments, the radiopaque labelling of the present invention can also be selected
The material such as 304 stainless steel tubes or tantalum capillary tube makes developing ring, and pipe box can also select PTFE tube set.
As shown in figure 5, the invention also discloses a kind of preparation method of balloon catheter for expanding vertebra structure, including following step
Suddenly：
S10, injection mo(u)lding Y-piece body 8 and pipe cap 10；
S20, bonding supports seal wire 5 and seal wire cap 6；
S30, prepares sacculus 2, and identifies outer tube 3, sacculus 2 is set in 3 one end of outer tube, and a pipe box is set in outer tube
3 with sacculus junction, weld fastening pipe sleeve；
S40, after completing step S10 and step S30, connects outer tube 3 and Y-piece body 8；
S50, connects the pipe cap 10 of inner tube 4 and Y-piece body 8；
S60, after completing step S50, installs radiopaque labelling 7 in inner tube 4；
S70, after completing step S40 and step S60, connects Y-piece body 8 and pipe cap 10；
S80, after completing step S70, pipe box is set in the joint of inner tube 4 and balloon distal 20, and welds fastening, will
Balloon distal 20 is sealed；
S90, after completing step S20 and step S80, will support seal wire 5 to insert in inner tube 4, by needleless joint 9 installed in the
At three interfaces 13, using compression pump, sacculus 2 is evacuated by the 3rd interface 13, so that balloon expandable segment outer radius is diminished complete for 2-4mm
Become assembling.
Need any is described, the symbol of S10 to S90 is arranged, and does not mean that preparation process according to numeral from small to large
Carry out successively, simply a kind of setting of identification for convenience of description, the step of concrete preparation method successively on order, with text
Word narration is named being defined of successively carrying out, and also refers to Fig. 5.
In a preferred embodiment of the present invention, step S20 includes following operation：
First, it is transferred in syringe cylinder after glue is thoroughly mixed；
Second, through hole of the seal wire 5 through seal wire cap 6 will be supported, and is placed vertically downward；
3rd, filled up with glue in the through hole of seal wire cap 6 with syringe cylinder, the state upwards of seal wire cap 6 is kept, is waited
The glue solidifies.
In a preferred embodiment of the present invention, the operation for welding fastening pipe sleeve in step S30 includes following operation：
First, the first mandrel with alcohol wipe outer tube 3 and for supporting outer tube 3；
Second, preheated weld machine；
3rd, the first mandrel is inserted in outer tube 3, pipe box is enclosed within the junction of outer tube 3 and sacculus 2, it is desirable to pipe box
One end is substantially flush with one end of outer tube 3；
4th, pipe box is placed on bonding machine station, welding makes pipe box be fastenedly connected with outer tube 3 and sacculus 2.
In a preferred embodiment of the present invention, step S40 includes following operation：
First, heat-shrinkable tube is inserted in outer tube 3, with fixture, heat-shrinkable tube is fixed on and closes at sacculus 2；
Second, glue is uniformly coated in one end of the no sacculus of outer tube 3, the outer tube 3 of glue will be then coated along
The first interface 11 of one mandrel insertion Y-piece body 8；
3rd, keep outer tube 3 to have one end of sacculus state upwards, until dried；
4th, fixture to be removed, mobile heat-shrinkable tube shrinks heat-shrinkable tube to outer tube 3 and 8 junction of Y-piece body.
It should be noted that permissible heat-shrinkable tube number in step S40 can be multiple.
In a preferred embodiment of the present invention, step S50 includes following operation：
Second mandrel is inserted inner tube 4；Glue is uniformly coated in the frosted end of inner tube 4, then by inner tube 4 along
In two mandrels insertion pipe cap 10, rocking makes glue penetrate into uniformly；The glue solidifies for wait.
In a preferred embodiment of the present invention, step S60 includes following operation：
First, two radiopaque labellings are cut angle one end along inner tube 4 and is inserted in；
Second, the inner tube 4 with pipe cap 10 is sequentially passed through line part 14 and the outer tube 3 of Y-piece body 8；Pipe cap 10 and Y type
Body 8 is detachably connected closing on to coordinate at second interface 12, and two platinum rings are located in sacculus 2.
In a preferred embodiment of the present invention, step S70 includes following operation：
First, the second mandrel is inserted inner tube 4；Inner tube 4 with pipe cap 10 sequentially passes through the line part 14 of Y-piece body 8
And outer tube 3, pipe cap 10 and the holding certain distance of Y-piece body 8；
Second, glue being injected to Y-connector second interface 12, pipe cap 10 is inserted in 8 second interface 12 of Y-piece body, delays
Slowly rotate to locking；
3rd, maintain sacculus end state upwards, until dried.
In a preferred embodiment of the present invention, step S80 includes following operation：
First, the second mandrel is inserted inner tube 4, is extended at radiopaque labelling 7；Then 20 sheathed pipe of balloon distal again
Set, pipe box is not contacted with the expansion of sacculus；
Second, the coupling part of welding socket and sacculus；Heating welding is carried out to being cased with collar portion, until welding；
3rd, the second mandrel is extracted, inserts threeth seal wire of the dimensions less than the second mandrel；Welded under its support again
Adapter set and the coupling part of sacculus；
4th, the 3rd seal wire and pipe box is removed, coupling part of the balloon distal after welding with said inner tube is cut,
The horizontal segment of 0.5-5mm is outwards retained in 20 dilation of balloon distal.
It should be noted that above-described embodiment all can independent assortment as needed.The above is only the preferred of the present invention
Embodiment, it is noted that for those skilled in the art, in the premise without departing from the principle of the invention
Under, some improvements and modifications can also be made, these improvements and modifications also should be regarded as protection scope of the present invention.
Claims (10)
1. a kind of balloon catheter for expanding vertebra, it is characterised in that including sacculus, outer tube, inner tube, support seal wire, seal wire cap, impermeable
Radiographic marker and Y-connector；
The Y-connector includes Y-piece body, needleless joint and pipe cap；The Y-piece body includes line part and from the straight line
The sidepiece of part expenditure, the two ends of the line part are respectively arranged with first interface and second interface, the overhanging one end of the sidepiece
The 3rd interface is provided with, the first interface closes on the junction of the line part and the sidepiece；The pipe cap is arranged on institute
State in second interface, the needleless joint is arranged on the 3rd interface；
Side channels are provided with the sidepiece, and the first end of the outer tube is connected with the side channels, the outer tube
The second end is turned on the balloon interior；The balloon proximal is welded and fixed by pipe box with the outer tube；
Said inner tube is worn along the outer tube, and one end of said inner tube is extended down to the pipe outside the first end by the outer tube
Cap, the other end of said inner tube extends through the balloon interior outside the second end of the outer tube, the distal end of the sacculus with
Said inner tube is welded and fixed by pipe box；The pipe cap is provided with the passage of insertion, and the pipe cap is with said inner tube by described
Glue in passage is adhesively fixed；
The support seal wire is placed in said inner tube through the pipe cap, and described support seal wire one end is provided with seal wire cap, institute
State seal wire cap to be connected with the pipe cap；It is provided with the middle part of the seal wire cap and places the thread eye for supporting seal wire, the support seal wire
It is plugged in the thread eye fixing.
2. balloon catheter for expanding vertebra according to claim 1, it is characterised in that the radiopaque labelling is arranged on institute
State at the inner catheter in sacculus, two are arranged side by side, be made up of 304 stainless steel tubes, platinum pipe or tantalum capillary tube；The needleless connects
Head is embedded with silica gel plug.
3. a kind of preparation method of balloon catheter for expanding vertebra structure, it is characterised in that comprise the following steps：
S10, Y-piece body and pipe cap described in injection mo(u)lding；
S20, bond the support seal wire and the seal wire cap；
S30, prepares the sacculus, and the sacculus is set in outer tube one end, and by a pipe box be set in the outer tube with described
Sacculus junction, the welding fastening pipe box；
S40, after completing step S10 and step S30, connects the outer tube and the Y-piece body；
S50, connects the pipe cap of said inner tube and the Y-piece body；
S60, after completing step S50, installs radiopaque labelling in said inner tube；
S70, after completing step S40 and step S60, connects the Y-piece body and the pipe cap；
S80, after completing step S70, the distal end of the sacculus is sealed；
S90, after completing step S20 and step S80, by the support seal wire insertion said inner tube, needleless is connect
Head is arranged on the 3rd seam, evacuates the sacculus using compression pump by the 3rd interface, makes balloon expandable part
External diameter diminishes as 2-4mm and completes assembling.
4. the preparation method of balloon catheter for expanding vertebra structure according to claim 3, it is characterised in that the step
S20 includes following operation：
First, it is transferred in syringe cylinder after glue is thoroughly mixed；
Second, seal wire being supported through the through hole of the seal wire cap by described, and places vertically downward；
3rd, filled up with glue in the through hole of the seal wire cap with the syringe cylinder, keep seal wire cap shape upwards
State, the glue solidifies for wait.
5. the preparation method of balloon catheter for expanding vertebra structure according to claim 3, it is characterised in that the step
In S30, the operation of the welding fastening pipe box includes following operation：
First, the first mandrel with alcohol wipe outer tube and for supporting outer tube；
Second, first mandrel is inserted in the outer tube, pipe box is enclosed within the junction of the outer tube and the sacculus,
One end of the pipe box and one end of the outer tube is asked to be substantially flush；
3rd, pipe box is placed on bonding machine station, welding makes pipe box be fastenedly connected with the outer tube and the sacculus.
6. the preparation method of balloon catheter for expanding vertebra structure according to claim 5, it is characterised in that the step
S40 includes following operation：
First, heat-shrinkable tube is inserted in the outer tube, with fixture, the heat-shrinkable tube is fixed on and closes at the sacculus；
Second, glue is uniformly coated in one end of the outer tube no sacculus, the outer tube of glue will be then coated along described
First mandrel inserts the first interface of the Y-piece body；
3rd, keep outer tube to have one end of sacculus state upwards, until dried；
4th, the fixture to be removed, the movement heat-shrinkable tube shrinks institute to the outer tube and the Y-piece body junction
State heat-shrinkable tube.
7. the preparation method of balloon catheter for expanding vertebra structure according to claim 3, it is characterised in that the step
S50 includes following operation：Second mandrel is inserted said inner tube；Glue is uniformly coated in the frosted of said inner tube
End, then by said inner tube in second mandrel insertion pipe cap, rocking makes glue penetrate into uniformly；The glue solidifies for wait.
8. the preparation method of balloon catheter for expanding vertebra structure according to claim 7, it is characterised in that the step
S60 includes following operation：
First, two radiopaque labellings are inserted in along inner tube one end；
Second, the said inner tube with the pipe cap is sequentially passed through line part and the outer tube of the Y-piece body；The pipe cap with
The Y-piece body is closing on cooperation at the second interface, and two radiopaque labellings are in the sacculus.
9. the preparation method of balloon catheter for expanding vertebra structure according to claim 7, it is characterised in that the step
S70 includes following operation：
First, second mandrel is inserted said inner tube；Said inner tube with the pipe cap sequentially passes through the Y-piece body
Line part and outer tube, the pipe cap and the Y-piece body keep certain distance；
Second, glue being injected to the Y-connector second interface, the pipe cap is inserted in the Y-piece body second interface, is delayed
Slowly rotate to locking；
3rd, maintain sacculus end state upwards, until dried.
10. the preparation method of balloon catheter for expanding vertebra structure according to claim 7, it is characterised in that the step
S80 includes following operation：
First, second mandrel is inserted said inner tube, extends to the radiopaque mark；Then the sacculus is remote again
Sheathed pipe box is held, the pipe box is not contacted with the balloon expandable part；
Second, weld the coupling part of the pipe box and the sacculus；Heating welding is carried out to being cased with collar portion, until weldering
Jail；
3rd, the balloon distal after welding and the coupling part of said inner tube are cut, in balloon distal dilation
Outwards retain the horizontal segment of 0.5-5mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610859893.4A CN106422032A (en) | 2016-09-28 | 2016-09-28 | Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610859893.4A CN106422032A (en) | 2016-09-28 | 2016-09-28 | Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106422032A true CN106422032A (en) | 2017-02-22 |
Family
ID=58170697
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610859893.4A Pending CN106422032A (en) | 2016-09-28 | 2016-09-28 | Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106422032A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108853694A (en) * | 2018-09-12 | 2018-11-23 | 杭州耕鑫生物科技有限公司 | A kind of biology sacculus dilating catheter |
| CN111729180A (en) * | 2020-05-28 | 2020-10-02 | 广州新诚生物科技有限公司 | Vertebral body expansion device and using method |
| CN113367759A (en) * | 2021-06-16 | 2021-09-10 | 成都昌华科技有限责任公司 | Disposable controllable unilateral trachea obturator and preparation process thereof |
| CN114469256A (en) * | 2022-01-28 | 2022-05-13 | 上海玮琅医疗科技有限公司 | Thrombus capturing covered stent and manufacturing process thereof |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5002559A (en) * | 1989-11-30 | 1991-03-26 | Numed | PTCA catheter |
| CN1350471A (en) * | 1999-05-11 | 2002-05-22 | 钟渊化学工业株式会社 | Balloon catheter |
| US20070027520A1 (en) * | 2005-07-27 | 2007-02-01 | Sherburne Paul S | Stent removal from a body |
| CN2905092Y (en) * | 2006-05-12 | 2007-05-30 | 上海凯利泰医疗科技有限公司 | Balloon catheter for expanding vertebra |
| US20110208287A1 (en) * | 2009-03-25 | 2011-08-25 | Svelte Medical Systems, Inc. | Stent Delivery Catheter With Balloon Control Bands |
| CN202569052U (en) * | 2012-03-20 | 2012-12-05 | 上海煜兴医疗器械有限公司 | Needleless connector |
| CN103055411A (en) * | 2013-01-25 | 2013-04-24 | 业聚医疗器械(深圳)有限公司 | Balloon catheter and manufacturing method thereof |
-
2016
- 2016-09-28 CN CN201610859893.4A patent/CN106422032A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5002559A (en) * | 1989-11-30 | 1991-03-26 | Numed | PTCA catheter |
| CN1350471A (en) * | 1999-05-11 | 2002-05-22 | 钟渊化学工业株式会社 | Balloon catheter |
| US20070027520A1 (en) * | 2005-07-27 | 2007-02-01 | Sherburne Paul S | Stent removal from a body |
| CN2905092Y (en) * | 2006-05-12 | 2007-05-30 | 上海凯利泰医疗科技有限公司 | Balloon catheter for expanding vertebra |
| US20110208287A1 (en) * | 2009-03-25 | 2011-08-25 | Svelte Medical Systems, Inc. | Stent Delivery Catheter With Balloon Control Bands |
| CN202569052U (en) * | 2012-03-20 | 2012-12-05 | 上海煜兴医疗器械有限公司 | Needleless connector |
| CN103055411A (en) * | 2013-01-25 | 2013-04-24 | 业聚医疗器械(深圳)有限公司 | Balloon catheter and manufacturing method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108853694A (en) * | 2018-09-12 | 2018-11-23 | 杭州耕鑫生物科技有限公司 | A kind of biology sacculus dilating catheter |
| CN108853694B (en) * | 2018-09-12 | 2024-02-27 | 深圳脉动医学技术有限公司 | Biological saccule dilating catheter |
| CN111729180A (en) * | 2020-05-28 | 2020-10-02 | 广州新诚生物科技有限公司 | Vertebral body expansion device and using method |
| CN113367759A (en) * | 2021-06-16 | 2021-09-10 | 成都昌华科技有限责任公司 | Disposable controllable unilateral trachea obturator and preparation process thereof |
| CN114469256A (en) * | 2022-01-28 | 2022-05-13 | 上海玮琅医疗科技有限公司 | Thrombus capturing covered stent and manufacturing process thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN106422032A (en) | Balloon catheter for vertebral expansion and preparation method of balloon catheter for vertebral expansion | |
| CN205729570U (en) | Ink vessel transfusing implant and implant is deployed in the delivery apparatus in health tremulous pulse | |
| CN102905751B (en) | The conduit dressing of sealed, sterile | |
| CN106794064B (en) | Prothesis implant body conveying device | |
| CN101415377B (en) | Delivery system and method for self-centering a proximal end of a stent graft | |
| US5303718A (en) | Method and device for the osteosynthesis of bones | |
| CN100522091C (en) | Systems and methods for reducing fractured bone using a fracture reduction cannula | |
| CN104602646B (en) | There is the prothesis implant body conveyer device of introducer conduit | |
| US10258471B2 (en) | Catheter | |
| CN103476349B (en) | Balloon-stent device and application method | |
| CN2905092Y (en) | Balloon catheter for expanding vertebra | |
| CN103127602B (en) | Balloon catheter | |
| CN109803591A (en) | Left auricle of heart disabler | |
| RU2013146851A (en) | Fracture Fixing System with Intramedullary Support | |
| CN107028641A (en) | Device for intravascular intervention | |
| CN201426912Y (en) | High-voltage expansive balloon structure | |
| CN107320173A (en) | Vertebral body augmentation formation system and method | |
| CN102247200A (en) | Vertebral oriented dilated balloon catheter | |
| CN101537223A (en) | Expansion structure for expanding saccule by high pressure | |
| CN109745114A (en) | A kind of multi-functional vertebral plasty instrument | |
| CN104758090A (en) | Involvement type heart valve prosthesis stent convenient to accurately locate and preparation method thereof | |
| TWI530271B (en) | Support device for femoral head | |
| CN104921763B (en) | A kind of device for being used to repair skull base defects | |
| CN106539603A (en) | A kind of basis cranii repair apparatus and method | |
| CN106166093B (en) | Double balloon-stents with side opening of expansible branch vessel |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170222 |