CN205126494U - Intermediate layer metal coating silicon pneumatic rubber capsules lung false body - Google Patents
Intermediate layer metal coating silicon pneumatic rubber capsules lung false body Download PDFInfo
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- CN205126494U CN205126494U CN201520843539.3U CN201520843539U CN205126494U CN 205126494 U CN205126494 U CN 205126494U CN 201520843539 U CN201520843539 U CN 201520843539U CN 205126494 U CN205126494 U CN 205126494U
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- 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
- A61F2/02—Prostheses implantable into the body
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/043—Bronchi
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The utility model discloses an intermediate layer metal coating silicon pneumatic rubber capsules lung false body provides a shape size and has been amputated the unanimous safe and harmless lung false body of lung, effectively fills, eliminates the residual cavity to prevention postoperative complication improves lung excision the life quality of the patient.
Description
Technical field
This utility model relates to a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese.
Background technology
Pneumonectomy is applied to clinical more than 80 years, is one of effective Therapeutic Method of pulmonary carcinoma, pulmonary tuberculosis Alkaline SCGE, or the treatment means taked of having to.The all more general Lung operation of post total pneumonectomy complication rate and mortality rate is high, is a difficult problem for thoracic surgery always.The factor that complication occurs is a lot, and interact, according to the pathological factor occurred, pneumonectomy infectious-related complication can be roughly divided into two kinds: one, and to be pulmonary circulation change the blood circulation dysfunction that postoperative single pulmonary circulation produces into, as cardiac arrhythmia, pulmonary hypertension, right heart insufficiency etc. by preoperative two pulmonary circulation.This complication occurs in early postoperation, and incidence rate is high, as long as but preoperative there is no heavier heart disease and find in time, punishment correctly generally can correct.Two is that the huge residual cavity after full pneumonectomy cannot disappear, and both sides pleural pressure is unbalance, causes pendular movement of mediastinum, mediastinal displacement because rib supports; Cardiovascular injuries displacement, torsion; Strong Hyperinflation causes bronchus stretching, distortion, the narrow and infection that occurs together; Also have a large amount of hydrops of inevitable residual cavity, cause patient's instrument for circulation of body fluid and protein loss, and the risk etc. of potential generation empyema.This complication healthhazard is relevant with the health status before protopathy kind and operation in patients, varies with each individual; Minority develops into " post total pneumonectomy syndrome (PPS) " that mortality rate is very high, treatment difficulty is very large.For eliminating residual cavity, the early stage filling such as plastic beads (Lucite ball), table tennis once using light weight both at home and abroad, abandons because causing the mortality complication such as airway obstruction, infection, traumatic aneurysm.The prevention and controls of generally acknowledging at present, carry out the management of early postoperation thoracic cavity, residual cavity will retain a certain amount of blood, tissue fluid and air, and by increasing or reduce the method for residual chamber air, adjustment mediastinum position, until the protein coagulation in pleural fluid, fibrous connective tissue hypertrophy, pleural thickening, Thoracic sink, mediastinum is fixed.But the method makes residual cavity and patient coexist, and produces a series of complication, has a strong impact on the quality of life of patient.
Utility model content
The purpose of this utility model is to overcome the deficiencies in the prior art part, provide a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese, provide the safe and harmless lung prosthese that a kind of shape size is consistent with cut lung, effective filling, elimination residual cavity, thus prevention of postoperative complication, improve patients ' life quality.
This utility model solves the technical scheme that its technical problem adopts:
A kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese, comprising:
Lung prosthese body, be the inflatable flexible cystic structures consistent with patient's cut lung shape size, cyst wall comprises the outer silastic-layer, intermediate metal layer and the interior silastic-layer that are laminated together successively;
Be placed under patient chest skin for regulating the gas injection seat of intraluminal pressure to injecting gas in lung prosthese body, this gas injection seat comprises gas injection seat body and the valve of gas injection of can puncturing, be provided with sealing mechanism and elastic mechanism in this gas injection seat body, between sealing mechanism and gas injection seat body, be formed with air chamber; This elastic mechanism comprises elastic component and is provided with the elastic plate of puncture gas injection place; The card support of sealing mechanism, at elastic component, is slided by resilient member deforms to make sealing mechanism and is resisted against elastic plate separably in gas injection seat body; Coordinate gas injection seat is changed between gas injection state and sealing state with elastic mechanism by sealing mechanism; During gas injection state, sealing mechanism is separated with elastic plate and gas is entered by gas injection place of puncturing or flowed out air chamber; During sealing state sealing mechanism be resisted against elastic plate and elastic plate generation elastic deformation with closed puncture gas injection place and sealed air chamber; This valve is fixed in gas injection seat body and is communicated with air chamber;
Airway, one end of this airway is sealingly connected to lung prosthese body and is communicated with lung prosthese body interior, and the other end of this airway is sealingly connected to valve and is communicated with air chamber.
In one embodiment: at the bottom of described gas injection seat body also comprises, pedestal and cover for seat; Be discoid at the bottom of this and upper surface is provided with annular groove; This pedestal is inverted round aecidioid, and at the bottom of circle cup cup, there are a circle hole in central authorities; Pedestal is together with being sealingly connected to dismantledly at the bottom of seat and the circle cup rim of a cup of pedestal is resisted against on annular groove; Described elastic component to be located in pedestal and its lower end abutment on annular groove; Described elastic plate is located at the bottom of the circle cup cup of pedestal; Described sealing mechanism is seal cup, sealing glass holder to be connected in this pedestal and at the bottom of seal cup, pedestal and seat between form described air chamber; The periphery wall of seal cup has outwardly flange, the support of this flange lower surface card in elastic component upper end, by resilient member deforms to realize sealing cup and slide up and down in pedestal and the rim of a cup end face of sealing cup is resisted against elastic plate separably; The outside of this flange is resisted against the internal face of pedestal, and this flange portion is incised to make the place of incising form gas passage; During gas injection state the rim of a cup end face of seal cup be separated with elastic plate and gas by puncturing gas injection place and cross gas passage and enter or flow out air chamber; There is local elastic deformation with closed puncture gas injection place and sealed air chamber in the rim of a cup end face contact elastic plate of seal cup during sealing state and elastic plate; The circle cup wall of cup that described valve is fixed in pedestal is communicated with air chamber; This elastic plate extends to pedestal form described cover for seat outward through circle hole, at the bottom of this cover for seat sealed envelope pedestal and seat and the outwardly formation shade shape structure of present bottom.
In one embodiment: described lung prosthese body is provided with the diaphragm seal for closed lung prosthese body identical with cyst wall structure, and one end of airway is sealingly connected on sealing sheet.
In one embodiment: the outer wall of described annular groove is provided with female thread; The circle cup rim of a cup outer wall of pedestal is provided with external screw thread; Together with the seat end and pedestal to be sealingly connected to external screw thread dismantledly by female thread and the circle rim of a cup of pedestal be resisted against on annular groove.
In one embodiment: described outer silastic-layer thickness is 0.4 ~ 0.5mm; Described interior silastic-layer thickness is 0.2 ~ 0.3mm; Described intermetallic metal layer thickness is μm 8 ~ 15 μm, and metal is titanium and/or aluminum.
In one embodiment: the rim of a cup end face of sealing cup is arc surface.
In one embodiment: described cover for seat upper surface is provided with for the depression touching location that punctures.
In one embodiment: also comprise for puncturing and the aerating device of gas injection, this aerating device comprises gas injection pin; This gas injection pin comprises the needle guard that is used in conjunction with each other and is slidably socketed the puncture needle core in needle guard; This needle guard and puncture needle core form detachable socket join structure; Separately be provided with a detachable stage clip nook closing member be socketed in needle guard; This puncture needle core front end is sharp coniform and stretch out outside needle guard, and this needle guard sidewall has some staggered micropores, and needle guard front end and puncture needle core seamlessly transit; After puncturing cover for seat and elastic plate by needle guard together with puncture needle core, puncture needle core is replaced by stage clip nook closing member, stage clip nook closing member stretches in gas injection seat together with needle guard and contact seal cup changes gas injection state to make gas injection seat into by sealing state downwards.
In one embodiment: also comprise the mould for the preparation of lung prosthese body, the hands handle that this mould comprises the consistent shelly lung model of lung shape cut with patient and is arranged on shelly lung model; This handle is tubular structure, and handle one end stretched in shelly lung model is connected with a bolt and the bolt head shutoff mouth of pipe, screw rod be positioned at pipe outer and with handle center's dead in line, and screw rod embedding is locked in the shelly lung model wall of handle installing hole offside; An affixed pin vertical with handle on handle, this pin is positioned at handle installing hole place and is embedded in shelly lung model wall; Handle is provided with some for making the inner passage communicated with the external world of shelly lung model in the part of shelly lung model intracavity.
The raw material that this utility model adopts, reagent, instrument etc., unless otherwise indicated, all can be commercially available; The techniques and methods that this utility model adopts, unless otherwise indicated, is routine techniques in field.
The technological difficulties that the technical program solves are as follows:
1. based on the thoracic CT data of this utility model before operation in patients, 3D printing technique is utilized to produce the model of cut lung, and then produce the air bag lung prosthese of individuation human implantable, after making the thoracic surgery older generations eliminate full pneumonectomy with completion method, the ideal of residual cavity is achieved.
2. silicone rubber is with the feature of its physicochemical stability and human compatibility, and make various implantable medical apparatus and be applied to clinical nearly 40 years, defining industry, is that oneself has technology.But there is no precedent for making air bag lung prosthese.More importantly silicon rubber thin film body breathability is strong, the function of air bag lung prosthese then requires that it is preferably airtight, this utility model adds very thin vacuum metal film plating layer between two-layer silicon rubber film for this reason, define in fact a kind of advanced composite material (ACM) based on silicone rubber, metal film and human tissue organ comprise hemocyte can not any contact, it just in time counteracts the breathability of silicone rubber to the iris action of gas molecule, have complementary advantages, made the air bag lung prosthese of the huge residual cavity prevention of postoperative complication that implantable pneumonectomy is formed.
The technical program is compared with background technology, and its tool has the following advantages:
1. lung prosthese body shape size of the present utility model is consistent with the cut lung of patient, and can keep stable in considerable time (more than three months); Wall is thin, soft, smooth, light weight, does not produce the mechanical damages such as friction to heart stolen goods and trunk; Material is harmless to human-body safety, without rejection and infection; And the manufacturing cycle is short, cost is low, is usually no more than ten days from determining to be implanted to implement to perform the operation.
2. post total pneumonectomy early stage thoracic cavity management, be listed in contemporary thoracic surgery difficult and complicated illness, the huge residual cavity that this utility model is formed after eliminating full pneumonectomy, effectively can prevent a series of complication caused by residual cavity, likely shorten length of patient stay simultaneously, save medical expense, alleviate patient suffering, be conducive to postoperative rehabilitation, improve the quality of living; Also thoracic surgeon's pressure in this respect and work load can be alleviated to a certain extent.
3. the current full pneumonectomy of row, mainly patients with lung cancer.Pulmonary carcinoma is the malignant tumor that global incidence rate is the highest, mortality rate is the highest, and according to classical documents data estimation, about there are 2.4 ~ 3.4 ten thousand examples in China every year because of the full pneumonectomy of pulmonary carcinoma row.About 4000 yuan of the price of a current silicone rubber breast prosthesis, manufacture difficulty of the present utility model and technology content, large more than breast prosthesis, by every only 8000 ~ 10000 yuan, if there is the whole year patient of the full pneumonectomy of 1/3 row to implant lung prosthese, can form the domestic market demand of about 100,000,000 yuan, economic benefit is also fine.
4. the implantation of lung prosthese eliminates residual cavity, reduces the risk of PPS, is applicable to mortality rate too very high, the PPS treatment that treatment difficulty is very large.
5. because the residual cavity of inferior lobe of right lung and the rear formation of superior lobe of left lung excision is also very large, complication is also very serious, and this utility model is not only applicable to full pneumonectomy, be applicable to lobectomy of lungs too, be 3D by using the CT scan data of selectivity lobe of the lung nonionic iodine preparation atomization radiography to print, this utility model can be utilized completely to produce the air bag prosthese of the cut lobe of the lung, further expand range of application of the present utility model, thus produce larger Social and economic benef@.
Accompanying drawing explanation
Below in conjunction with drawings and Examples, the utility model is described in further detail.
Fig. 1 is interlayer metal plated film Silicon rubber inflatable bag lung borrowed structure schematic diagram of the present utility model.
Fig. 2 is the three-decker schematic diagram of lung prosthese body cyst wall of the present utility model.
Fig. 3 is gas injection holder structure schematic diagram of the present utility model.
Fig. 4 is seat bottom structure schematic diagram of the present utility model.
Fig. 5 is base structure schematic diagram of the present utility model.
Fig. 6 is gas nozzle structure schematic diagram of the present utility model.
Fig. 7 is the structural representation that pedestal of the present utility model and valve are connected.
Fig. 8 is seal cup structural representation of the present utility model.
Fig. 9 is the schematic top plan view of seal cup of the present utility model.
Figure 10 is spring structure schematic diagram of the present utility model.
Figure 11 is the structural representation that shelly lung model of the present utility model and handle are connected.
Figure 12 is needle guard structural representation of the present utility model.
Figure 13 is the enlarged local section schematic diagram of Figure 12.
Figure 14 is the structural representation that needle guard of the present utility model and puncture needle core are connected.
Figure 15 is the enlarged local section schematic diagram of Figure 14.
Figure 16 is the structural representation that needle guard of the present utility model and stage clip nook closing member are connected.
Figure 17 is the part section enlarged diagram of Figure 16.
Reference numeral: lung prosthese body 10, outer silastic-layer 11, intermediate metal layer 12, interior silastic-layer 13; Gas injection seat 20, at the bottom of seat 21, pedestal 22, spring 23, elastic silicone rubber plate 231, seal cup 24, flange 241, valve 25, cover for seat 26, depression 261, air chamber 27, crosses gas passage 28; Airway 30; Diaphragm seal 40; Gas injection pin 50, needle guard 51, micropore 511, puncture needle core 52, stage clip nook closing member 53; Shelly lung model 60; Handle 70, bolt 71, pin 72, pore 73; Vertical thickness H between cast gate outer wall to shelly lung model offside outer wall.
Detailed description of the invention
Content of the present utility model is illustrated below by embodiment:
As shown in Figure 1, a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese, comprising:
Lung prosthese body 10, be the inflatable flexible cystic structures consistent with patient's cut lung shape size, cyst wall comprises outer silastic-layer 11, intermediate metal layer 12 and the interior silastic-layer 13 (as shown in Figure 2) be laminated together successively; This outer silastic-layer 11 fits in chest wall in use, and thickness can regulate as required, such as, be 0.4 ~ 0.5mm; This interior silastic-layer 13 thickness can regulate as required, such as, be 0.2 ~ 0.3mm; This intermediate metal layer 12 thickness can regulate as required, such as, be 0.008 ~ 0.015mm, and metal is titanium and/or aluminum;
Under being placed in patient chest skin and for injecting gas in lung prosthese body 10, the gas injection seat 20 (as shown in Figure 3) regulating intraluminal pressure, this gas injection seat comprises gas injection seat body and the valve of gas injection of can puncturing, be provided with sealing mechanism and elastic mechanism in this gas injection seat body, between sealing mechanism and gas injection seat body, be formed with air chamber; This elastic mechanism comprises elastic component and is provided with the elastic plate of puncture gas injection place; The card support of sealing mechanism, at elastic component, is slided by resilient member deforms to make sealing mechanism and is resisted against elastic plate separably in gas injection seat body; Coordinate gas injection seat is changed between gas injection state and sealing state with elastic mechanism by sealing mechanism; During gas injection state, sealing mechanism is separated with elastic plate and gas is entered by gas injection place of puncturing or flowed out air chamber; During sealing state sealing mechanism be resisted against elastic plate and elastic plate generation elastic deformation with closed puncture gas injection place and sealed air chamber; This valve is fixed in gas injection seat body and is communicated with air chamber;
Airway 30, described lung prosthese body 10 is provided with the diaphragm seal 40 for closed lung prosthese body 10 identical with cyst wall structure, one end of this airway 30 is sealingly connected to sealing sheet 40 place and is communicated with lung prosthese body 10 inside, and the valve 25 that the other end of this airway 30 is sealingly connected to gas injection seat 20 is communicated with air chamber 27; And this valve 25 end is provided with the structure preventing airway 30 from coming off, such as shuttle-type is expanded; Valve 25 end also can be set to turriform, mushroom-shaped etc.The making material of airway 30 can also adopt silicone rubber or the material identical with cyst wall structure to make.
Among the present embodiment, the concrete structure of described gas injection seat 20 can be: 21 (as shown in Figure 4), pedestal 22 (as shown in Figure 5) and a cover for seat 26 at the bottom of described gas injection seat body also comprises; At the bottom of this, 21 for discoid and upper surface is provided with annular groove; This pedestal 22 is inverted round aecidioid, and at the bottom of circle cup cup, there are a circle hole in central authorities; Pedestal 22 with 21 to be connected dismantledly and the circle cup rim of a cup of pedestal 22 is resisted against on annular groove at the bottom of seat; Described elastic component is spring 23, to be located in pedestal 22 and its lower end abutment on annular groove; Described elastic plate is elastic silicone rubber plate 231, is located at the bottom of the circle cup cup of pedestal 22; Described sealing mechanism is seal cup 24 (as shown in Figure 8 and Figure 9), and sealing cup 24 to be socketed in this pedestal 22 and to form described air chamber 27 between 21 at the bottom of seal cup 24, pedestal 22 and seat; The periphery wall of seal cup 24 has outwardly flange 241, card support of this flange 241 lower surface, in spring 23 upper end, is out of shape to realize sealing cup 24 by spring 23 and is slided up and down in pedestal 22 and the rim of a cup end face of sealing cup 24 is resisted against elastic silicone rubber plate 231 separably; The rim of a cup end face of sealing cup 24 can be set to arc surface, prevents damage elasticity silicane rubber plate 231; The outside of this flange 241 is resisted against the internal face of pedestal 22, and this flange 241 part incises to make the place of incising form gas passage 28; During gas injection state, seal cup 24 glides and its rim of a cup end face is separated with elastic silicone rubber plate 231 under external force, and gas is by puncture gas injection place and cross gas passage 28 and enter or flow out air chamber 27; During sealing state, seal cup 24 resets and its rim of a cup end face contact elastic silicone rubber plate 231 under spring 23 acts on, there is local elastic deformation in elastic silicone rubber plate 231, now puncture gas injection place on elastic silicone rubber plate 231 is closed with air chamber 27 is isolated by seal cup 24, and air chamber 27 is sealed; The circle cup wall of cup that described valve 25 is fixed in pedestal 22 is communicated with air chamber 27; This elastic silicone rubber plate 231 extends to through circle hole that pedestal 22 is outer forms described cover for seat 26, at the bottom of this cover for seat 26 sealed envelope pedestal 22 and seat 21 and the present end 21 place outwardly formation shade shape structure; Be convenient to gas injection seat 20 to sew up be fixed in sub-dermal soft tissue; This cover for seat 26 upper surface is provided with for the depression 261 touching location that punctures;
Among the present embodiment, the seat end 21, pedestal 22, spring 23, seal cup 24, valve 25 are all made with the material meeting medicine implantation utensil standard, such as rustless steel, cover for seat 26 is made with silicone rubber, be convenient to make gas injection seat 20 form the elastomer of surfacing, also gas leakage can be stopped, and good with the tissue compatibility;
Among the present embodiment, described pedestal 21 with at the bottom of seat 22 attaching mode be such as: the outer wall of annular groove is provided with female thread, the inwall of described annular groove be at the bottom of the sidewall of 21 central, circular platforms; The circle cup rim of a cup outer wall of pedestal 22 is provided with external screw thread; The seat end 21 and pedestal 22 are connected dismantledly by female thread and external screw thread, filled silicon rubber encapsulant in thread pitch and the circle cup rim of a cup of pedestal is resisted against on annular groove; Described valve 25 is fixed in above this external screw thread.
Also comprise:
For cover for seat 26 and elastic silicone rubber plate 231 and the aerating device to gas injection in gas injection seat 20 of puncturing, this aerating device comprises inflator and gas injection pin 50; As shown in Figure 12 to 17, this gas injection pin 50 comprises the needle guard 51 that is used in conjunction with each other and is slidably socketed the puncture needle core 52 in needle guard 51, and both form detachable socket join structure; Separately be provided with a detachable stage clip nook closing member 53 be socketed in needle guard 51; This puncture needle core 52 front end is sharp coniform and stretch out outside needle guard 51, this needle guard 51 front end can be set to and form with the coniform front end of puncture needle core 52 shape seamlessly transitted, so that together thrust cover for seat 26 with puncture needle core 52, this needle guard 51 sidewall has some staggered ventilative micropores 511; This stage clip nook closing member 53 can be positioned at same plane with the end of needle guard 51;
The preparation method of above-mentioned interlayer metal plated film Silicon rubber inflatable bag lung prosthese is as follows:
1) according to patient chest iconography data, as the initial data of CT lung window scanning, DICOM formatted data is changed into the STL formatted data needed for 3D printing, plastics that are conventional, low, the easy polishing of price such as the 3D such as LPA, ABS are adopted to print the plastics lung model of cut lung, the processing of this plastics lung model is modified, as filled and led up with atomized ash, dark and little hole is recessed, crack etc., polishes the crest line etc. that pointed shape is protruding and sharp keen, makes its smooth surface and meets the requirement of silastic product mould; This technical requirement is known techniques in field;
2) above-mentioned plastics lung model is suspended on model conversion case central authorities that colourless transparent material (as rigid transparent materials such as colourless transparent resin glass plates) makes and plastics lung model surrounding is unsettled, in this model conversion case, slowly inject translucent or transparent mould liquid room temperature vulcanized silicone rubber and embedded gradually by plastics lung model, in this process, continuous model of vibration cross box is to make the bubble-free attachment of plastics lung model surface; (heat up and can shorten hardening time, but root Ju experience is no more than 80 DEG C after silicone rubber cold curing 24h; Also other can be taked to accelerate the measure of solidification), open model conversion case, the silicone rubber embedding plastics lung model cuts by the maximum cross-section along plastics lung model, take out plastics lung model, the silicone rubber para-position of cutting is restored, retighten in model conversion case, namely obtain the former of lung prosthese body 10, the mechanism of hanging plastics lung model is the cast gate of former;
3) with dentistry mold powder, 200 height of eye strength gypsum powder and water, or dentistry phosphate investment, the slurry for making gypsum mold or phosphate mould is mixed with by the using method of product description and requirement, using step 2) in hang the passage that stays of plastics lung model place as cast gate, the slurry of now joining is injected former by gradation, after each injection immediately multiaxis to rotational model cross box to be coated on the internal chamber wall of former with making slurry uniform bubble-free, pour into a mould again after slurry solidifies next time; After casting complete and slurry solidify completely, open model conversion case, remove former, prepare the shelly lung model 60 that wall thickness is 6 ~ 8mm; One is installed for making the inner handle 70 (as shown in figure 11) communicated with the external world of model 60 at the corresponding gate location place of shelly lung model 60; Shelly lung model 60 with handle 70 is carried out processing to modify, scabble the little aliform projection because former gap is formed, eliminate various streak marks, fill and lead up pitting because of bubble formation recessed etc., make its smooth surface and meet the standard of silastic product mould; Then be placed in baking oven and carry out ladder-elevating temperature drying, until the quality substantially constant of mould; Again carry out processing to shelly lung model 60 surface of drying to modify, if there are the defects such as the pit of pin hole or bubble formation to be remedied in time, eliminate macroscopic defect; Then shelly lung model 60 surface uniform spraying good film-forming property, heat-resisting 180 ~ 200 DEG C, strong and easily and the non-toxic coatings peeled off of silicone rubber with shelly lung model 60 adhesion, among the present embodiment, coating is epoxy resin (TEY-2810), solidify 2h at 80 DEG C, other coating meeting above-mentioned condition are as modified polyurethane etc.Again check the mould after paint solidification, making its smooth surface and meet the standard of silastic product mould, obtaining the mould for making lung prosthese body 10;
4) by hardness be the methyl alkene based two-component platinum of 50 shore units implant medical grade silicon rubber for a long time A, B two kinds respectively with petroleum ether, according to the proportions silicone rubber petroleum ether solution of 90 ~ 110g:500ml, then silicone rubber petroleum ether solution identical for two kinds of concentration is mixed with Ludox with the ratio uniform of volume ratio 1:1; In 18 ~ 20 DEG C of constant temperature, dustless, aseptic closed environment, above-mentioned Ludox gradation is evenly watered built in step 3) die surface that obtains, the hand-held handle 70 of operator, constantly rotate mould by handle 70 according to Ludox trickling situation evenly to trickle coating at die surface to make Ludox, solvent volatilizees gradually thus forms the silicone rubber membrane that thickness is 0.2 ~ 0.3mm.The silicone rubber membrane that die face is formed is avoided and any object contact, hangs or be erected in baking oven with handle, and ladder-elevating temperature is shaped, sulfidization molding under 120 ~ 160 DEG C/4 ~ 6h condition, silastic-layer 13 within described in obtaining;
5) to step 4) surface that obtains carries out vacuum coating with the mould of interior silastic-layer 13, forms described intermediate metal layer 12 on interior silastic-layer 13 surface; Should prevent any dust and foreign substance from polluting in this process; This vacuum coating process can adopt magnetron sputtering technology, vacuum resistance thermal evaporation coating technique, vacuum electron beam evaporation coating techniques etc., general equipment and parameter is adopted to complete, as long as interior silastic-layer closely can be attached to die surface, and is interlinked to the outside in mould.Select titanium to do coated target material, being because titanium and human body have the good compatibility, is generally acknowledged implantable material.Aluminium is because its fusing point is low, good manufacturability, and application popularization is extensive, and aluminizer cost only has 1/10 of titanium, and the metallic aluminium of lung prosthese does not contact with human tissue organ, and existing experiment proves harmless.
6) repeat step 4) method, in step 5) silastic-layer 11 outside the surface preparation of the intermediate metal layer 12 that obtains is described, prepare lung prosthese body semi-finished product;
7) centered by handle 70, lung prosthese body semi-finished product are cut the delivery hole of a diameter 2 ~ 3cm, pull down handle 70, take out after mold breakdown through this delivery hole rongeur or other instruments; Or do not damaging without rongeur in half-finished situation, by pulling down handle 70 from delivery hole after mold breakdown and taking out mould fragment, obtain lung prosthese body 10;
8) with airway 30 diaphragm seal 40 heat-seal identical with cyst wall structure or bond close above-mentioned delivery hole; After utilizing prior art to prepare gas injection seat 20, airway 30 other end is sealingly connected to the valve 25 of gas injection seat 20, obtains described interlayer metal plated film Silicon rubber inflatable bag lung prosthese.
Among the present embodiment, described step 3) in, install one at the corresponding gate location place of shelly lung model 60 and comprise for making the method for the inner handle 70 communicated with the external world of model:
31) the vertical thickness H (㎜ between cast gate outer wall to shelly lung model offside outer wall is measured);
32) making of handle 70 is chosen external diameter 16 ~ 20mm, is grown the steel pipe of 20 ~ 22 ㎝, and steel pipe one end is connected with M6 or M8 bolt 71, and 71, this bolt and the steel pipe seam shutoff mouth of pipe, the screw rod of bolt 71 is positioned at manages outward and the two central axes; Upwards measure H-3mm position from screw rod end and make a call to a pinhole; The intracavity section of handle is between pinhole and bolt head; Intracavity section tube wall is made a call to 2 ~ 3 diameters be 3 ~ 4mm half bore 73 with ensure shelly lung model 60 inside communicate with the external world, retention pin is injected pin-and-hole tightly;
33) handle installing hole of a diameter slightly larger than outer diameter of steel pipes is made a call at the corresponding cast gate place of shelly lung model 60, open a length and width through this center, hole slightly larger than the pin grooves of pin, the model oppose side wall that cast gate is corresponding is opened the bolt mounting holes of a diameter slightly larger than bolt; Stretch into model 60 in one end of bolt from above-mentioned handle installing hole by handle 70, screw rod injects bolt mounting holes end lower than model surface 1 ~ 2 ㎜, and retention pin is inlayed into pin grooves; Sealing handle 70 and shelly lung model 60 attaching place is embedded with the high strength gypsum slurry compared with stiff, all any activity can not be had at the initial stage model of sealing and handle, until slurry solidify firm after sealing place processing modification made to consistent (as shown in figure 11) before itself and mounting handle 70, obtain the mould for making lung prosthese body.
This utility model onsite application mode is as follows:
1) excise cut lung, after confirming to meet pass breast condition, through otch, the lung prosthese body 10 of unaerated is placed in patient chest residual cavity;
2) needle guard 51 and puncture needle core 52 are socketed, utilize puncture needle core 52 puncture cover for seat 26 and elastic silicone rubber plate 231 to have fall through sense time, puncture needle core 52 is replaced by stage clip nook closing member 53, stage clip nook closing member 53 drives needle guard 51 to stretch in gas injection seat 20 and contact seal cup 24 downwards, spring 23 is compressed, seal cup 24 glides and rim of a cup end face is separated with elastic silicone rubber plate 231, gas injection seat 20 changes gas injection state into by sealing state, keep that needle guard 51 position is motionless is taken out by stage clip nook closing member 53 and inflator is connected needle guard 51, air enters in air chamber 27 from needle guard 51 front opening and sidewall pores 511 through gas passage 28, lung prosthese body 10 is entered again through airway 30.Needle guard 51 can adopt the needle guard that intervene operation is conventional, due to softer, therefore needs to coordinate with stage clip nook closing member 53; As required, during the needle guard selecting hardness larger, also stage clip nook closing member can not be set, utilize the downward contact seal cup 24 of needle guard to make it glide and also can;
According to said method, under the monitoring of gas tosimeter and effusion meter, in lung prosthese body 10, slowly air is injected through gas injection seat 20, it is made to expand gradually, doctor then changes the orientation of lung prosthese body 10 lentamente, and under anesthetist coordinates, the impression making lung prosthese body 10 and thoracic wall, mediastinum corresponding, depression, projection are corresponding; Progressively increase gas injection rate, finally make lung prosthese body 10 and thoracic wall fit; Extract needle guard 51, seal cup 24 resets and the rim of a cup end face contact elastic silicone rubber plate 231 of seal cup 24 under spring 23 acts on, elastic deformation is there is in elastic silicone rubber plate 231 with the rim of a cup end face contact position of seal cup 24, now puncture gas injection place on elastic silicone rubber plate 231 is closed with air chamber 27 is isolated by seal cup 24, gas in air chamber 27 is sealed, can not be leaked by puncture gas injection, gas injection seat is being sealing state by gas injection state transfer;
3) doctor determines the need of placement drainage strip according to actual operation situation;
4) gas injection seat 20 is sewed up be fixed on beyond operative incision subcutaneous, fixing airway 30, is monitored pressure in lung prosthese body 10 according to clinical needs by gas injection seat and imaging examination, and is regulated at any time as required by gas injection seat 20;
5) there is the case of pleura oozing of blood, hemorrhage can be coated with outside lung prosthese body 10, and suitably to improve in lung prosthese body 10 pressure with hemostasis.
Cut lung described in the utility model can be full pneumonectomy, also can be lobectomy of lungs; Full pneumonectomy can adopt CT lung window scan-data; Lobectomy of lungs prints by using the CT scan data of selectivity lobe of the lung nonionic iodine preparation atomization radiography to be 3D.But not as limit, as long as cut part can be determined by detection methods such as iconographys, method of the present utility model can be utilized to prepare lung prosthese, all fall in scope that this utility model contains.
The above, be only this utility model preferred embodiment, therefore the scope that this utility model implements can not be limited according to this, the equivalence namely done according to this utility model the scope of the claims and description change with modify, all should still belong in scope that this utility model contains.
Claims (9)
1. an interlayer metal plated film Silicon rubber inflatable bag lung prosthese, is characterized in that: comprising:
Lung prosthese body, be the inflatable flexible cystic structures consistent with patient's cut lung shape size, cyst wall comprises the outer silastic-layer, intermediate metal layer and the interior silastic-layer that are laminated together successively;
Be placed under patient chest skin for regulating the gas injection seat of intraluminal pressure to injecting gas in lung prosthese body, this gas injection seat comprises gas injection seat body and the valve of gas injection of can puncturing, be provided with sealing mechanism and elastic mechanism in this gas injection seat body, between sealing mechanism and gas injection seat body, be formed with air chamber; This elastic mechanism comprises elastic component and is provided with the elastic plate of puncture gas injection place; The card support of sealing mechanism, at elastic component, is slided by resilient member deforms to make sealing mechanism and is resisted against elastic plate separably in gas injection seat body; Coordinate gas injection seat is changed between gas injection state and sealing state with elastic mechanism by sealing mechanism; During gas injection state, sealing mechanism is separated with elastic plate and gas is entered by gas injection place of puncturing or flowed out air chamber; During sealing state sealing mechanism be resisted against elastic plate and elastic plate generation elastic deformation with closed puncture gas injection place and sealed air chamber; This valve is fixed in gas injection seat body and is communicated with air chamber;
Airway, one end of this airway is sealingly connected to lung prosthese body and is communicated with lung prosthese body interior, and the other end of this airway is sealingly connected to valve and is communicated with air chamber.
2. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 1, is characterized in that: at the bottom of described gas injection seat body also comprises, pedestal and cover for seat; Be discoid at the bottom of this and upper surface is provided with annular groove; This pedestal is inverted round aecidioid, and at the bottom of circle cup cup, there are a circle hole in central authorities; Pedestal is together with being sealingly connected to dismantledly at the bottom of seat and the circle cup rim of a cup of pedestal is resisted against on annular groove; Described elastic component to be located in pedestal and its lower end abutment on annular groove; Described elastic plate is located at the bottom of the circle cup cup of pedestal; Described sealing mechanism is seal cup, sealing glass holder to be connected in this pedestal and at the bottom of seal cup, pedestal and seat between form described air chamber; The periphery wall of seal cup has outwardly flange, the support of this flange lower surface card in elastic component upper end, by resilient member deforms to realize sealing cup and slide up and down in pedestal and the rim of a cup end face of sealing cup is resisted against elastic plate separably; The outside of this flange is resisted against the internal face of pedestal, and this flange portion is incised to make the place of incising form gas passage; During gas injection state the rim of a cup end face of seal cup be separated with elastic plate and gas by puncturing gas injection place and cross gas passage and enter or flow out air chamber; There is local elastic deformation with closed puncture gas injection place and sealed air chamber in the rim of a cup end face contact elastic plate of seal cup during sealing state and elastic plate; The circle cup wall of cup that described valve is fixed in pedestal is communicated with air chamber; This elastic plate extends to pedestal form described cover for seat outward through circle hole, at the bottom of this cover for seat sealed envelope pedestal and seat and the outwardly formation shade shape structure of present bottom.
3. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 1, it is characterized in that: described lung prosthese body is provided with the diaphragm seal for closed lung prosthese body identical with cyst wall structure, and one end of airway is sealingly connected on sealing sheet.
4. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 2, is characterized in that: the outer wall of described annular groove is provided with female thread; The circle cup rim of a cup outer wall of pedestal is provided with external screw thread; Together with the seat end and pedestal to be sealingly connected to external screw thread dismantledly by female thread and the circle rim of a cup of pedestal be resisted against on annular groove.
5. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 1, is characterized in that: described outer silastic-layer thickness is 0.4 ~ 0.5mm; Described interior silastic-layer thickness is 0.2 ~ 0.3mm; Described intermetallic metal layer thickness is 8 μm ~ 15 μm, and metal is titanium and/or aluminum.
6. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 2, is characterized in that: the rim of a cup end face of sealing cup is arc surface.
7. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 2, is characterized in that: described cover for seat upper surface is provided with for the depression touching location that punctures.
8. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 2, is characterized in that: also comprise for puncturing and the aerating device of gas injection, this aerating device comprises gas injection pin; This gas injection pin comprises the needle guard that is used in conjunction with each other and is slidably socketed the puncture needle core in needle guard; This needle guard and puncture needle core form detachable socket join structure; Separately be provided with a detachable stage clip nook closing member be socketed in needle guard; This puncture needle core front end is sharp coniform and stretch out outside needle guard, and this needle guard sidewall has some staggered micropores, and needle guard front end and puncture needle core seamlessly transit; After puncturing cover for seat and elastic plate by needle guard together with puncture needle core, puncture needle core is replaced by stage clip nook closing member, stage clip nook closing member stretches in gas injection seat together with needle guard and contact seal cup changes gas injection state to make gas injection seat into by sealing state downwards.
9. a kind of interlayer metal plated film Silicon rubber inflatable bag lung prosthese according to claim 1, it is characterized in that: also comprise the mould for the preparation of lung prosthese body, the handle that this mould comprises the consistent shelly lung model of lung shape cut with patient and is arranged on shelly lung model; This handle is tubular structure, and handle one end stretched in shelly lung model is connected with a bolt and the bolt head shutoff mouth of pipe, screw rod be positioned at pipe outer and with handle center's dead in line, and screw rod embedding is locked in the shelly lung model wall of handle installing hole offside; An affixed pin vertical with handle on handle, this pin is positioned at handle installing hole place and is embedded in shelly lung model wall; Handle is provided with some for making the inner passage communicated with the external world of shelly lung model in the part of shelly lung model intracavity.
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| CN201520843539.3U CN205126494U (en) | 2015-10-28 | 2015-10-28 | Intermediate layer metal coating silicon pneumatic rubber capsules lung false body |
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| CN201520843539.3U CN205126494U (en) | 2015-10-28 | 2015-10-28 | Intermediate layer metal coating silicon pneumatic rubber capsules lung false body |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10258457B1 (en) | 2018-07-04 | 2019-04-16 | Ghassan E. Jweied | Dynamic dual chamber breathing prosthesis and methods |
| CN109717993A (en) * | 2018-12-13 | 2019-05-07 | 云南省第一人民医院 | A kind of Breast Surgery postoperative rehabilitation auxiliary device |
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2015
- 2015-10-28 CN CN201520843539.3U patent/CN205126494U/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10258457B1 (en) | 2018-07-04 | 2019-04-16 | Ghassan E. Jweied | Dynamic dual chamber breathing prosthesis and methods |
| CN109717993A (en) * | 2018-12-13 | 2019-05-07 | 云南省第一人民医院 | A kind of Breast Surgery postoperative rehabilitation auxiliary device |
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| Date | Code | Title | Description |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20160406 Termination date: 20181028 |