CN100560035C - A kind of negative pressure therapeutic instrument that is used for the treatment of femur head necrosis - Google Patents
A kind of negative pressure therapeutic instrument that is used for the treatment of femur head necrosis Download PDFInfo
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- CN100560035C CN100560035C CNB2007100182279A CN200710018227A CN100560035C CN 100560035 C CN100560035 C CN 100560035C CN B2007100182279 A CNB2007100182279 A CN B2007100182279A CN 200710018227 A CN200710018227 A CN 200710018227A CN 100560035 C CN100560035 C CN 100560035C
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- negative pressure
- therapeutic instrument
- suction catheter
- compound film
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Abstract
The invention discloses a kind of Avascular Necrosis Of Femur Head therapeutic instrument that is used for the treatment of, at least include composite membrane, the man machine interface control system, the pressure control module, liquid containing bottle, adopt polymer compound film as the encapsulant that produces negative pressure, utilize composite membrane to offer the suitable microenvironment of osteanagenesis and reparation and the effect of somatomedin on the one hand; Utilize negative pressure to promote the effect of osteocyte propagation, enrichment of cell and somatomedin and promotion angiogenic growth on the other hand, on compound film tube, add and use vacuum suction, can fully utilize film guided bone osteanagenesis and negative pressure-induced osteanagenesis, thus accelerated bone regeneration.Therapeutic instrument adopts modularized design, and each assembly is relatively independent, adopts three kinds of powering modes, and has/under-voltage protection function, and microcontroller cooperates the high-precision pressure sensor monitoring that negative pressure pump and air relief valve are controlled automatically; Carry out a series of control operations such as negative pressure and time are provided with easily by keyboard, all simultaneously operations and data all can show.
Description
Technical field
The invention belongs to medical apparatus and instruments, relate to a kind of therapeutic instrument that is used for Avascular Necrosis Of Femur Head.
Background technology
Avascular Necrosis Of Femur Head whole world patient 3,000 ten thousand people that have an appointment, China has 4,000,000 people approximately, good being sent out in 31～60 years old.More about the capital Therapeutic Method of the downright bad reservation of adult thighbone head, be divided into non-operative treatment and operative therapy, non-operative treatment is avoided heavy burden, Drug therapy, electrical stimulating therapy etc., operative therapy comprises the bone transplanting of core decompression art, osteotomy, bone grafting operation, the confession of band blood etc., follows up a case by regular visits to most patient long term and still need go joint replacement.The common drawback of these treatment therapies is that Biomechanical factor is considered inadequately.The modern viewpoint of ischemic necrosis of femoral head treatment should be conceived to how to prevent from long term to subside, from the design of biology and biomechanics two aspects consideration art formula.
Summary of the invention
In order to overcome the limitation of existing Avascular Necrosis Of Femur Head Therapeutic Method, further improve the cure rate of Avascular Necrosis Of Femur Head, shorten treatment time, the present invention intends promoting on the basis of osteanagenesis theory at present, select for use composite membrane as the encapsulant that produces negative pressure, when operation, composite membrane and silica gel three lumens are implanted, utilize the guided bone osteanagenesis principle and the negative pressure of film to promote osteocyte propagation, the effect of somatomedin secretion and angiogenic growth, operative therapy and non-operative treatment are organically combined, a kind of novel Avascular Necrosis Of Femur Head therapeutic instrument is provided.This therapeutic instrument adopts composite membrane as the encapsulant that produces negative pressure, on the basis of core decompression operation principle, the integrated application vacuum suction promotes osteanagenesis technology and film guided bone osteanagenesis technology, principle of negative pressure and composite membrane are organically combined, utilize negative pressure to reduce the femoral head pressure inside on the one hand, and can promote the effect of osteocyte propagation, somatomedin secretion and angiogenic growth; Utilize film to offer the effect of suitable microenvironment, enrichment of cell and the somatomedin of osteanagenesis and reparation on the other hand.By multidisciplinary intersection cooperation, design and the therapeutic instrument of producing have international and domestic originality.Have easy to operate, intelligent, portable, high in technological content, can with advantages such as existing Avascular Necrosis Of Femur Head Therapeutic Method docks.
In order to realize above-mentioned task, the present invention adopts following technical solution:
A kind of negative pressure therapeutic instrument that is used for the treatment of femur head necrosis is characterized in that, this therapeutic instrument includes at least:
Composite membrane is used to be coated on around the position of fracture or bone does not connect, and this composite membrane is connected with silica gel three lumens; The structure of described polymer compound film is divided into outer field semipermeable membrane and inner membrance, and the about 3～5mm of general thickness is made as the cylindric of hollow in advance, in the implanted unit bone reduced pressure zone; Inner membrance is the bigger spongy film of pore diameter, its structure is very imperfect honeycomb structure foam, surround around the suction catheter of silica gel three lumens, be used for being connected with silica gel three lumens, suction catheter inserts 5cm in the composite membrane, the suction catheter insertion portion has a plurality of side openings, act as to make pressure evenly be delivered to the semipermeable membrane surface; Silica gel three lumens adopt the good medical silica-gel manufacturing of biocompatibility, are divided into syringe, gas tube and suction catheter, and the suction catheter external diameter is 3～5mm, internal diameter 2～4mm; Syringe diameter 1～2mm is positioned at the suction catheter tube chamber; The gas tube front end connects air bag, and air bag is positioned at the opening part of femur head and neck reduced pressure zone, can closed channel after the inflation; The suction catheter leading portion inserts 4cm in the composite membrane, and insertion portion prepares the side opening of diameter 1mm in advance with the distance of 3mm * 3mm with laser.
The man machine interface control system comprises microcontroller, is connected with keyboard array, LCD MODULE, real-time clock module, RS232 communication module, ADC/ front end circuit, power-supply system and mistake/under-voltage protection module on the microcontroller respectively;
The pressure control module, this pressure control module is made up of negative pressure pump, electromagnetic valve and pressure transducer, and negative pressure pump, electromagnetic valve all adopt LMDS Light Coupled Device to be connected with the microcontroller of man machine interface control system;
One liquid containing bottle, this liquid containing bottle is connected on the negative pressure pump of pressure control module, and links to each other with composite membrane by silica gel three lumens, and described silica gel three lumens are made up of syringe, suction catheter and gas tube, between suction catheter connection and composite membrane and the liquid containing bottle, play the vacuum suction effect; Syringe one end permeation composite membrane inner surface, the other end and suction catheter are drawn side by side, and the front end of gas tube is connected with air bag.
The inner membrance pore diameter is 50～200 μ m, utilizes improved Sal drench filter/freeze-dried method preparation; Adventitia is a semipermeable membrane, and pore diameter utilizes the preparation of wood template method and Breath figure method less than 10 μ m.
The pressure control module is made up of negative pressure pump and electromagnetic valve and pressure transducer, adopts the micromachining technology manufacturing, can measure Korrosionsmedium.Signal of sensor is sent into the A/D conversion chip after amplifying through amplifier, and under the driving of 4.096V reference voltage, conversion accuracy can reach 1mV.Make the control accuracy of this pressure transducer control module reach 1mmHg.
Negative pressure pump all adopts LMDS Light Coupled Device to be connected with microcontroller with electromagnetic valve, and when microcontroller provided pressurization signal, negative pressure pump work also provided lasting negative pressure; When microcontroller provided depression signal, electromagnetic valve was opened decompression.All pressurizations and decompression process all carry out under the monitoring of pressure transducer automatically, guarantee that the pressure in the liquid containing bottle is precisely controlled.
1000 milliliters of liquid containing bottle capacity, there are pressure transducer and capacity sensor in inside, and when internal pressure and liquid capacity surpassed the scope of permissible value, holding circuit started and the control cut off between microcontroller and the negative pressure pump is got in touch.Microcontroller detects control and gets in touch when being cut off, and can send/the undervoltage warning signal.
Microcontroller adopts the P89V51RD2 model single-chip microcomputer of Philips company, has the flash of 64kB byte and the RAM of 1kB byte, supports the ISP/IAP function.Under the control of pressure transducer, can accurately regulate and control negative pressure value, guarantee to attract the effectiveness and the safety of process.Simultaneously, system can also write down the treatment record 100 times, comprises treatment zero-time and pressure value.The treatment record can utilize the RS232 interface will treat record and upload on the computer, has realized the storage and the query function of treatment record.
The man machine interface control system comprises microcontroller, is connected with keyboard array, LCD MODULE, real-time clock module, RS232 communication module, ADC/ front end circuit, power-supply system and mistake/under-voltage protection module on the microcontroller respectively;
Keyboard array adopts ZLG7289 keyboard chip, is connected with microcontroller by four pins.When button was pressed, the ZLG7289 chip can produce an external hardware and interrupt, and had no progeny during the microcontroller response is somebody's turn to do and read key information from the DIO pin, carried out operation accordingly, realized the control of keyboard to complete machine.
The man machine interface control system comprises two subsystems in importation and display part.Wherein LCD display module pin directly links to each other with the microcontroller respective pins.ZLG7289 keyboard chip is adopted in the importation, is connected with microcontroller by four pins.When button was pressed, the ZLG7289 chip can produce an external hardware and interrupt, and had no progeny during the microcontroller response is somebody's turn to do and read key information from the DIO pin, carried out operation accordingly, realized the control of keyboard to complete machine.
The present invention is directed to the marrow inner high voltage theory of femur head necrosis, designed the negative pressure therapeutic instrument that is used for the treatment of femur head necrosis, this instrument had both been considered downright bad partial biological factor, also puted forth effort to improve local biomechanics environment, integrate operation and non-operative treatment advantage, curative effect is preferably arranged.
Negative pressure pump adopts modularized design, and each assembly is relatively independent, adopts microcontroller to cooperate the high-precision pressure sensor monitoring that negative pressure pump and air relief valve are controlled; Adopt friendly man machine interface, can carry out a series of control operations such as negative pressure is provided with easily by keyboard, all simultaneously operation and data all show on lcd screen.This portable vacuum extractor adopts three kinds of powering modes, and the overvoltage/undervoltage defencive function is arranged, and guarantees patient safety.
Description of drawings
Fig. 1 is a vacuum suction instrument system composition frame chart;
Fig. 2 is a composite membrane manufacturing process sketch map;
Fig. 3 is a pressure control module circuit diagram;
Fig. 4 is the pressure sensor module circuit diagram;
Fig. 5 is power supply design circuit figure;
Fig. 6 is man machine interface control system circuit theory diagrams;
Fig. 7 is structure of composite membrane and places sketch map.
The present invention is described in further detail below in conjunction with accompanying drawing.
The specific embodiment
Theoretical foundation of the present invention has 2 points: first is film guided bone osteanagenesis theory, provide an isolated microenvironment to bone exactly, make the skeletonization factor can be in Local enrichment, and the interference of soft tissue around not being subjected to, thereby strengthen skeletonization factor, accelerating union of bone fracture, bone regeneration function is at utmost brought into play.And the required histiocyte of film Guan Nengwei provides the regeneration space, the more important thing is that the microenvironment that it can provide suitable local cells and somatomedin to assemble and discharge increases factor concentrations such as cell density relevant with skeletonization and bone morphogenetic protein; Second is negative pressure-induced osteanagenesis theory, and negative pressure can regulate gene expression, promotes osteanagenesis, and the accelerated bone reconstruction promotes the growth of local vascular tissue, and the secretion of the promotion local cells factor is at the Local enrichment cell.On compound film tube, add and use vacuum suction, can the most effective strong point in conjunction with these two theories, thus the accelerated bone healing.
Device of the present invention mainly is made of polymer compound film, silica gel three lumens, pressure control module, liquid-accumulating bottle and man machine interface control system, shown in Fig. 1 theory diagram.
The man machine interface control system comprises microcontroller, is connected with keyboard array, LCD MODULE, real-time clock module, RS232 communication module, ADC/ front end circuit, power-supply system and mistake/under-voltage protection module on the microcontroller respectively;
The function of each several part and embodiment:
Polymer compound film is divided into adventitia and inner membrance, and the about 3～5mm of general thickness is made as the cylindric of hollow in advance, and in the implanted unit bone reduced pressure zone, the manufacturing process of film as shown in Figure 2.
1, prepare outer field semipermeable membrane:
Give by the hydrophilic tropocollagen molecule of grafting on hydrophobicity PLGA molecule that it is amphipathic, be used for the preparation of semipermeable membrane.Choose then the honeycomb structure aperture be positioned at 10～200 mu m ranges, be single disperse and the timber of different hole shapes as template, through control carbonization, vacuum/impregnating method, its honeycomb structure structure can be transferred on the bioabsorbable polymer material such as PLGA.The method that the wood template method makes up semipermeable membrane is:
1) pattern hole structural design
Design according to pore structure, selected timber directly or after Precision Machining, combination is used as template, the single shaft that obtains pore size even (the single dispersion) is to linear tubulose pore structure.[controllable aperture scope is 10～200 μ m, and contains pit (timber is inherent, and is common＜10 μ m) on its wall.Carbonisation can form a large amount of nano-pores, and porosity is 70～95%.For regulating and control the pore structure on the tubulose hole wall better, also in subsequent technique (dipping), introduce the sub-micron pore of hundreds of nm.
2) the membrane material design is with synthetic
For realizing grafting, with 1, the 6-hexamethylene diamine carries out aminolysis, and end is amino (NH2), to be used for the grafting of bioactive molecule collagen to obtain with polyester PLGA in elder generation.Utilize the amount of XPS quantitative analysis amino.
3) template is to the transformation of semipermeable membrane
For realizing the accurate transformation of pore structure, adopt nanometer casting-negative norm method, be specially:
The template that designs in the step 1) obtains the carbon porous body after vacuum carburization, infiltrate soluble-salt and oxidation removal carbon through the high-temperature vacuum fusion successively, obtain solid ' negative norm ' salt porous body, to contain the particulate PLGA solution that is grafted with collagen of submicron salt NaCl at last infiltrates in the negative norm, after ultrasonic warm water desalination, obtain semi-permeable polymer.
4) Breath figure method prepares semipermeable membrane
Promptly water polymer waterflooding under mobile humid air environment, can form orderly honeycomb structure structure, advantage is that method is simple, and arrange in the hole regularly has versatility in order, is that the preparation aperture is usually less than the Perfected process of 10 μ m films.Amphipathic biopolymer in this research is the PLGA of collagen graft modification.The major control factor has: humidity and temperature level, humid air flow velocity, polymer solution concentration size and polymer self physicochemical property etc., can regulate and control the pore size of semipermeable membrane by reconciling these factors.
Preparation inner membrance, inner membrance utilize improved Sal drench filter/freeze-dried method preparation, and can be made into average pore size is the foaming structure of 50～200 μ m and very imperfect honeycomb structure structure, uses as inner membrance.
Silica gel three lumens adopt the good medical silica-gel manufacturing of biocompatibility, are divided into syringe, gas tube and suction catheter, between suction catheter connection and composite membrane and the liquid containing bottle, play the vacuum suction effect; Syringe one end permeation composite membrane inner surface, the other end and suction catheter are drawn side by side, and the front end of gas tube is connected with air bag, and the suction catheter external diameter is 3～5mm, internal diameter 2～4mm; Syringe diameter 1～2mm is positioned at the suction catheter tube chamber; The gas tube front end connects air bag, and air bag is positioned at the opening part of femur head and neck reduced pressure zone, can closed channel after the inflation.The suction catheter leading portion inserts 4cm in the composite membrane, and insertion portion prepares the side opening of diameter 1mm in advance with the distance of 3mm * 3mm with laser.
The pressure control module is made up of negative pressure pump and electromagnetic valve and pressure transducer, and negative pressure pump all adopts LMDS Light Coupled Device to be connected with microcontroller with electromagnetic valve, as shown in Figure 3.When microcontroller provides pressurization signal (PUMP changes low level into), photoelectrical coupler is communicated with the power supply circuits of the negative pressure pump of being made up of metal-oxide-semiconductor and R4_5, R4_6, and negative pressure pump work also provides lasting negative pressure; When microcontroller provides depression signal (VALVE changes low level into), photoelectrical coupler is communicated with the power supply circuits of the negative pressure pump of being made up of metal-oxide-semiconductor and R4_2, R4_3, and electromagnetic valve is opened decompression.Adopt photoelectric coupled device to replace the control of relay realization to circuit, all pressurizations and decompression process all carry out under the monitoring of pressure transducer automatically, guarantee that the pressure in the liquid containing bottle is precisely controlled.Pressure transducer is arranged on the liquid containing bottle top as shown in Figure 4, adopts the super steady pressure pick off of 85 type silicon piezoresistance types.The employing micromachining technology is made, and is furnished with multiple standards hickeys such as 1/4NPT, 1/8NPT, 1/4BSP; Small size, low-power consumption can be measured Korrosionsmedium.Coupling makes its linearity that can reach 0-100mV under the exciting current of 1.5mA output by the constant current power supply circuits of being made up of stabilivolt and audion.Signal of sensor is sent into the A/D conversion chip after amplifying through amplifier.The A/D conversion chip adopts the MAX1236 chip, and this chip is 12 4 road A/D conversion chips that have the I2C bus, and under the driving of 4.096V reference voltage, conversion accuracy can reach 1mV.Thereby make the control accuracy of this pressure transducer control module can reach 1mmHg.This pressure transducer makes the pressure monitoring in the vacuum suction process realize with digitized form, has effectively promoted the accuracy of monitoring.
1000 milliliters of liquid containing bottle capacity, inside is provided with pressure transducer and capacity sensor, and when the pressure in the liquid containing bottle and capacity exceeded the scope of permissible value, holding circuit started and the control cut off between microcontroller and the negative pressure pump is got in touch.Microcontroller detects control and gets in touch when being cut off, and can send/the undervoltage warning signal, guarantees the safety of user.
Microcontroller adopts the P89V51RD2 model single-chip microcomputer of Philips company, has the flash of 64kB byte and the RAM of 1kB byte, supports the ISP/IAP function, can use the interior flash of sheet to be EEPROM under the IAP function and use; Can select to support 12 clocks or 6 clock modules by software or ISP.
Power design circuit figure as shown in Figure 5, and AC and DC power supply and three kinds of power supply designs of lithium battery are taked in the design of electric power system.Dc source adopts the Switching Power Supply design, and the 220V alternating voltage is converted to the 12V DC voltage; It is system's power supply that lithium battery adopts the battery of 10.8V, and charging circuit is external.The voltage of input is converted to stable 12V DC voltage through DC-DC conversion chip ADP1148, is 12V system power supplies such as negative pressure pump on the one hand, is converted to 5V voltage through a slice 7805 three terminal regulators on the other hand, is the numerical portion power supply of each system.System preferentially uses DC power supply, and automatically switches to battery powered when can dc source can't power, and guarantees that work process can not interrupt.
The RS232 communication module adopts MAX232 serial ports electrical level transferring chip, can write down the treatment record 100 times, comprises treatment zero-time and pressure value.The treatment record can utilize the RS232 interface will treat record and upload on the computer, carries out the data communication between single-chip microcomputer and the PC.This module is the key modules that vacuum extractor is connected with computer, by the conversion of level, the treatment record of storing in the microcontroller can be uploaded in the computer.
The man machine interface Control System Design as shown in Figure 7, comprise microcontroller, be connected with keyboard array, LCD MODULE, real-time clock module, RS232 communication module, ADC/ front end circuit, mistake/undervoltage warning module, power-supply system and mistake/under-voltage protection module on the microcontroller respectively; Wherein LCD MODULE is made of eight sections LCD array of display of 2 (row) * 20 (individual), can show several data.This LCD display module is in light weight, power consumption is little, peripheral circuit is simple, is the ideal display device of portable system.LCD display module pin directly links to each other with the microcontroller respective pins.ZLG7289 keyboard chip is adopted in the importation, coupling 4 * 5 matrix keyboards, comprise operation, stop, suspending, confirm four function buttons, four direction button and 0-9 totally 10 digital keys, the last pull down resistor of keyboard has 10 times resistance difference, and capacity of resisting disturbance is strong.The ZLG7289 chip is connected with microcontroller by four pins.When button was pressed, the ZLG7289 chip can produce an external hardware and interrupt, and had no progeny during the microcontroller response is somebody's turn to do and read key information from the DIO pin, carried out operation accordingly, realized the control of keyboard to complete machine.
Structure of composite membrane of this negative pressure therapeutic instrument and placement sketch map are as shown in Figure 7.
Claims (4)
1. a negative pressure therapeutic instrument that is used for the treatment of femur head necrosis is characterized in that, this therapeutic instrument includes at least:
Polymer compound film is used to be coated on around the position of fracture or bone does not connect, and this polymer compound film is connected with silica gel three lumens; The structure of described polymer compound film is divided into outer field semipermeable membrane and inner membrance, and general thickness 3～5mm is made as the cylindric of hollow in advance, in the implanted unit bone reduced pressure zone; Inner membrance is the bigger spongy film of pore diameter, its structure is very imperfect honeycomb structure foam, surround around the suction catheter of silica gel three lumens, be used for being connected with silica gel three lumens, suction catheter inserts 5cm in the polymer compound film, the suction catheter insertion portion has a plurality of side openings, act as to make pressure evenly be delivered to the semipermeable membrane surface; Silica gel three lumens adopt the good medical silica-gel manufacturing of biocompatibility, are divided into syringe, gas tube and suction catheter, and the suction catheter external diameter is 3～5mm, internal diameter 2～4mm; Syringe diameter 1～2mm is positioned at the suction catheter tube chamber; The gas tube front end connects air bag, and air bag is positioned at the opening part of femur head and neck reduced pressure zone, inflation rear enclosed passage;
The man machine interface control system comprises microcontroller, is connected with keyboard array, LCD MODULE, real-time clock module, RS232 communication module, ADC/ front end circuit, power-supply system and mistake/under-voltage protection module on the microcontroller respectively;
The pressure control module, this pressure control module is made up of negative pressure pump, electromagnetic valve and pressure transducer, and negative pressure pump, electromagnetic valve all adopt LMDS Light Coupled Device to be connected with the microcontroller of man machine interface control system;
One liquid containing bottle, this liquid containing bottle is connected on the negative pressure pump of pressure control module, and links to each other with polymer compound film by silica gel three lumens, and the suction catheter of described silica gel three lumens is connected between polymer compound film and the liquid containing bottle, plays the vacuum suction effect; Syringe one end permeation composite membrane inner surface, the other end and suction catheter are drawn side by side.
2. the negative pressure therapeutic instrument that is used for the treatment of femur head necrosis as claimed in claim 1 is characterized in that described polymer compound film is divided into two-layer, and adventitia is the macromolecule semipermeable membrane, and pore diameter is less than 10 μ m.
3. the negative pressure therapeutic instrument that is used for the treatment of femur head necrosis as claimed in claim 1; it is characterized in that; described mistake/under-voltage protection module is used for when the pressure of liquid containing bottle exceeds the scope of permissible value; holding circuit startup and the control of cutting off between microcontroller and the negative pressure pump are got in touch, and buzzing is reported to the police.
4. the negative pressure therapeutic instrument that is used for the treatment of femur head necrosis as claimed in claim 1, it is characterized in that described power-supply system is interchange, direct current, three kinds of power supplies of battery, wherein, dc source adopts the Switching Power Supply design, and alternating current power supply is converted to the 12V DC voltage for the 220V alternating voltage; And battery adopts the 10.8V lithium battery.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100182279A CN100560035C (en) | 2007-07-10 | 2007-07-10 | A kind of negative pressure therapeutic instrument that is used for the treatment of femur head necrosis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100182279A CN100560035C (en) | 2007-07-10 | 2007-07-10 | A kind of negative pressure therapeutic instrument that is used for the treatment of femur head necrosis |
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| CN101120887A CN101120887A (en) | 2008-02-13 |
| CN100560035C true CN100560035C (en) | 2009-11-18 |
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| CN105078553B (en) * | 2015-09-07 | 2017-06-09 | 北京市富乐科技开发有限公司 | Neck of femur side openings conduction decompression hollow lag screw system |
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Granted publication date: 20091118 Termination date: 20120710 |