CN102989064A - Sacculus medicine-spraying device for treating nasosinusitis or allergic rhinitis - Google Patents

Sacculus medicine-spraying device for treating nasosinusitis or allergic rhinitis Download PDF

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CN102989064A
CN102989064A CN2012104544369A CN201210454436A CN102989064A CN 102989064 A CN102989064 A CN 102989064A CN 2012104544369 A CN2012104544369 A CN 2012104544369A CN 201210454436 A CN201210454436 A CN 201210454436A CN 102989064 A CN102989064 A CN 102989064A
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sacculus
spraying device
medicine
sinus
chemical spraying
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CN102989064B (en
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谢建
魏征
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Puyi (Shanghai) Biotechnology Co.,Ltd.
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Pu Yi (shanghai) Biotechnology Co Ltd
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Abstract

The invention provides a sacculus medicine-spraying device for treating nasosinusitis or allergic rhinitis. The sacculus medicine-spraying device comprises an inflatable sacculus, a sacculus inner pipe and a sacculus catheter, wherein the sacculus inner pipe penetrates through the sacculus and extends axially; and the far-end opening of the sacculus catheter is ended in the sacculus. The sacculus medicine-spraying device provided by the invention has the advantages that the prepared effective treating medicine liquid or gelatinous or powdery solid particles can be conveyed to the diseased part of the paranasal sinus, and the cavity part of the frontal sinus and/or the maxillary sinus is used as a medicine storage device, so that the diseased part can be treated by medicines in enough-long treatment period. The sacculus medicine-spraying device also has the advantages that effective medicines are uniformly sprayed to the diseased part by minimally invasive surgery; the medicines stored on the frontal sinus and the maxillary sinus can be conveyed to the diseased part continuously in time along with the swinging of the cilium of the nasal cavity and the flowing of mucus of the nasal cavity; and before the stored medicines are metabolized, the medicines can be directly and continuously fed to the diseased part, and the treating effect of common medicine feeding is greatly improved.

Description

A kind of sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis
Technical field
The present invention relates to medical instruments field, relate more specifically to a kind of sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis.
Background technology
Sinusitis and allergic rhinitis are otorhinolaryngology commonly encountered diseases and frequently-occurring disease, betide between 5 ~ 79 years old.Hygiene department investigation shows: the sickness rate of present global allergic rhinitis is up to 10% to 14%, and the sinusitis sickness rate accounts for about 15% of population, and the whole world nearly has that 600,000,000 people are enduring " harassing and wrecking " of rhinitis to the fullest extent, and is progressively ascendant trend.
Wherein 66% asthmatic patient is the victim of allergic rhinitis.According to expert introduction, allergic rhinitis is as correctly being treated, and the patient above 1/3 finally develops into asthma.
Nasal sinuses claims again paranasal sinuses, paranasal sinus, is the sclerotin chamber of a plurality of gassiness around the nasal cavity, and they all communicate with nasal cavity with tubule.They are hidden on the nasal cavity next door, and as shown in Figure 1, maxillary sinus 9 is positioned at nasal cavity both sides, the upper jaw bone above the eye socket; Sinus frontalis 7 is in frontal bone; Sieve hole 8 is positioned at the both sides on nasal cavity top, is comprised of many gassiness loculuses in the screen casing; The sphenoid sinus (not shown) is in the bone of talking endlessly at nasal cavity rear.
Epidermal mucosa cell in normal person's nasal cavity and the nasal sinuses continues limpid liquid secretion is arranged out, the pulsation of rule rate is arranged via the cilium above the mucosa cells again, with these secretions from nasal sinuses, via nasal cavity flow to backward cavum nasopharyngeum, throat swallow again esophagus, and stomach.General adult secretes 1 liter mucus every day approximately, keeps the humidity of nasal cavity and nasal sinuses inside by these mucus, and dust and foreign body in the while absorbed air are with the health of protection respiratory tract.In case because the invasion of virus, antibacterial, or the stimulation of foreign body, it is thick to cause limpid mucus secretion to become pus, or the cilium forfeiture has the pulsation of rule rate, the capital produces the sensation of the thick nasal mucus of pus or nasal mucus refluence, and causes rhinitis or the swelling of nose film, all can make these tubules inaccessible.When these tubules are inaccessible, will have influence on the nasal cavity mucus and remain in a standstill in nasal sinuses, the impact discharging.If not early diagnosis and treatment, will develop becomes sinusitis, allergic rhinitis or other rhinitis.
When the nasal sinuses inflammation, can cause headache, nasal obstruction, rhinorrhea, temporary olfactory disorder, fear of cold, heating, inappetence, constipation, whole body discomfort etc.Than the small children child can vomit, the symptom such as diarrhoea, cough.The pus nasal mucus stimulates throat can also cause throat discomfort, pharyngolaryngitis etc.
And allergic rhinitis, behind common patient's contact or the suction sensitinogen, the IgE(IgE in the body) can cause that mastocyte discharges histamine, causes anaphylaxis.Allergen is the antigen that inducing specific IgE antibody also reacts with it.Their multi-sources are in animal, plant, insecticide, fungus or occupational material.Allergen mainly is divided into inhalant allergen and food allergen.The inhalant allergen is the main cause of allergic rhinitis.Patient's main manifestations of allergic rhinitis is that telangiectasis, permeability increase and glandular secretion increase and eosinophilic granulocyte infiltration etc.If above-mentioned disease is shown effect repeatedly, can cause that mucosal epithelium layer proliferative changes, and causes mucosa plumpness and Polypoid changes.Its symptom is similar to flu, mainly is the diseases such as rhinocnesmus, nasal obstruction, rhinorrhea, sneeze and stream clear water shape nasal mucus (runny nose), and intermittence is shown effect repeatedly, the pale edema of nasal mucosa during outbreak.Seriously also might develop into sinusitis, asthma or ear infection.
For the application of Drug therapy at nose diseases, adopt traditionally collunarium or spray to the mode of nasal cavity spraying medicine.Studies show that because the blocking of tissue, active drug can not reach diseased region smoothly under traditional therapeutic modality, can only with the medicinal liquid that is no more than 30% inhomogeneous send to diseased region, greatly reduce medication effect.
At present existing nasal cavity flushing device, can or contain the medicine liquid washing nasal cavity of medicine with normal saline, but of short duration drug effect almost only limits in the concha nasalis position, it is inner to arrive sinus frontalis and maxillary sinus hole body, can not be to inflammation nasal sinuses direct effect, and most nasal sinuses generation pathological changes can relate to nearly all hole body.In fact, even if medicinal liquid can enter hole body cavity inside, and for the hole body of sinus frontalis opening in the bottom, after cleaning or the spray medicine finishes, nearly all medicinal liquid all can be flowed out by Dou Kou, and medicine is also had no chance to be stored in its inside and carried out permanently effective treatment.
The functional nasal endoscope Minimally Invasive Surgery has especially significantly therapeutic effect to acute sinusitis and chronic sinusitis.Can remove accurately pathological tissues and bone, the nasal sinuses opening is enlarged, recover the normal physiological function of nasal sinuses.Findings in endoscopic sinus surgery has the incomparable invasive of traditional sinusitis operation.But nasal endoscopic surgery is expensive, treats not thoroughly, and very easily recurrence repeats to control expense and causes the financial burden of patient spirit heavy.
The operative therapy for the treatment of of allergic rhinitis mainly contains the treatment of nerve block art, low-temperature plasma art, the operation of concha nasalis inferior mucosa, reduces the operation of parasympathetic nervous irritability, and other operative therapy, but above-mentioned recurrence after operation rate is high, and expense is high.
Exactly because and the prolonged and repeated medicine of most of cacorhinia can not act on diseased region for a long time constantly, the treatment of discontinuity brings disease repeatedly to show effect.If can pass through simple Minimally Invasive Surgery, can the effect of more effective performance Drug therapy for the long-term site-directed quantitative administration of diseased region.
Application number be CN200620161536.2 patent disclosure " a kind of balloon dilatation catheter for the treatment of rhinitis, sinusitis ", wherein, air bag can reach the purpose that enlarges nasal meatus.Common inflammation does not occur in the nasal meatus, but is in the nasal sinuses position.And clinical fact shows, only is to the nasal meatus mechanical expansion, is temporary dredging respiration channel, and it is uncomfortable to alleviate disease, and the effect that suffers for want of medical supplies is very limited to the therapeutic effect of disease.
Application number be CN200420085915.9 patent disclosure a kind of " irrigation of maxillary sinus convergent divergent channel ", this convergent divergent channel is made by silica gel, be placed on maxillary sinus windowing or maxillary sinus the nature Dou Kou, by syringe pipe to carrying out irrigation and disinfection in the nasal sinuses.As be placed on the maxillary sinus windowing, and wound and the complication of having taked repeatedly inferior nasal meatus puncture operation that sufferer is brought although the sinusitis recurrence has been avoided in this convergent divergent channel design, antral window operation also is a kind of trauma operation, has equally traumatic harm.The known antral window operation of those skilled in the art is called again the maxillary sinus fistulation, and following common complication is arranged: 1, nasolacrimal canal injury, the rear Ipsilateral that causes performing the operation is shed tears for a long time incessantly.2, because of the fistulation position too partially after, the nose that has damaged greater palatine artery props up, or too partially, has damaged the superior labial artery nose and propped up, and causes epistaxis.3, cause concha nasalis inferior and nasal wall adhesion because post operative treatment is improper.In addition, the convergent divergent channel of this patent is claimed also can be placed on maxillary sinus nature Dou Kou, but as previously mentioned, because the sinusitis patient causes because of natural hole stenostomy, therefore this convergent divergent channel that has front wing and empennage is actually and can't be positioned over maxillary sinus nature Dou Kou place, thereby can't medicine directly be sprayed onto on sinusitis patient's the disease sites by the convergent divergent channel that this patent provides.
Application number be CN200780017176.6 patent disclosure a kind of nose tear drainage system implants for Drug therapy, by this implant with drug effect in the expection the position on.Because stenosis of lacrimal punctum need to insert dilator to expand in advance lacrimal point at lacrimal point before inserting this implant, the implant that contains medicine could enter into smoothly the reservation position and play a role.In other words, the implant by means of this patent provides can't directly be sprayed onto medicine on sinusitis patient's the disease sites equally.
US Patent No. 7,645, among the 272B2 " devices; systems and methods for treating disorders of the ear; nose and throat ", showed that a class is used for the device of nasal irrigation or sinus cavities, can be whereby the liquid conditions such as the normal saline of liquid state or pastille liquid medicine have been injected nasal sinuses.Generally, be limited to nasal sinuses and surrounding tissue thereof to the restriction of pressure bearing, the liquid that disperses spray prescription formula to spray into the single shaft punching can not cover pathological changes fully, and can only play simple rinse effect to nasal sinuses, and the time that stops in nasal sinuses is quite short.
Therefore, need a kind of device, can medicine directly be sprayed to diseased region by Minimally Invasive Surgery, and medicine is played a role for a long time.Can play the qualitative change effect to nasal cavity diseases such as Drug therapy sinusitis.
Summary of the invention
The purpose of this invention is to provide a kind of sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis, by the Minimally Invasive Surgery mode slow release treatment medicine directly is sprayed to the nasal cavity diseased region, and slow releasing pharmaceutical is stored in nasal cavity, realize longer continued treatment, thereby reduce the possibility of the palindromias such as sinusitis or allergic rhinitis, and reach the purpose of thorough healing by treatment.
In order to solve the problems of the technologies described above, technical scheme of the present invention provides a kind of sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis, this sacculus chemical spraying device comprises sacculus, sacculus inner tube and the foley's tube that can fill, described sacculus inner tube runs through described sacculus and extends axially, the distal openings of described foley's tube ends in the described sacculus, and described sacculus is the large sacculus in middle little two after full.
The distal openings of described sacculus inner tube ends at diseased region, sinus frontalis and/or maxillary sinus.
The proximal openings of described foley's tube links to each other with ball inflation pressure pump.
The proximal openings of described sacculus inner tube links to each other with vacuum draw equipment and/or drug storage.
This sacculus chemical spraying device also comprises the second sacculus and the second foley's tube, and the wall of described the second sacculus has at least one spray medicine aperture, and the distal openings of described the second foley's tube ends in described the second sacculus.
The proximal openings of described the second foley's tube links to each other with the second ball inflation pressure pump and/or drug storage.
Described spray medicine aperture is distributed on the wall of described the second sacculus equably.
The aperture of described spray medicine aperture is 0.1mm-2mm.
Described the second sacculus is positioned at diseased region, sinus frontalis and/or maxillary sinus.
The sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis of the present invention, effective medicine liquid of preparing or gel or pulverulent solids particle can be delivered to the Paranasal sinus diseases position, and with sinus frontalis and (or) maxillary sinus cavity part is as medicament reservoir, makes diseased region can both obtain Drug therapy within the sufficiently long treatment phase.With US Patent No. 7,645,272B2 thinks ratio, and sacculus chemical spraying device of the present invention is mainly used in solid-state or gel state granule spray medicine except can being used for liquid spray medicine, can connect other sprayer units granule is delivered to diseased region, sinus frontalis and/or maxillary sinus.Compare with pure liquid state, solid-state or gel medicine can bond together with nasal sinuses, be not easy to run off in a short time, and the solid granulates medicine is more suitable for long-time slow release.
Other benefits of this device are, at first, can active drug evenly be sprayed on diseased region by Minimally Invasive Surgery; Further, the medicine that is stored in sinus frontalis and maxillary sinus can in time be delivered to diseased region continually along with swing and the flowing of nasal cavity mucus of nasal cavity cilium, before the store medication metabolism is complete, can continue the direct administration of diseased region is significantly promoted common drug treatment effect.
Description of drawings
Fig. 1 is that the human body nasal sinuses is at the sketch map of head position;
Fig. 2 is the sketch map of the sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis according to a preferred embodiment of the present invention;
Fig. 3 is the sketch map of the sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis according to a further advantageous embodiment of the invention;
Fig. 4 is the partial enlarged drawing of the sacculus chemical spraying device of Fig. 3.
The specific embodiment
Below in conjunction with accompanying drawing, provide preferred embodiment of the present invention, and be described in detail, enable to understand better function, the characteristics that are used for the treatment of the sacculus chemical spraying device of sinusitis or allergic rhinitis of the present invention.
For convenience of description, hereinafter employed term " near-end " refers to an end nearer apart from the operator, and " far-end " refers to the end away from the operation technique person.
Embodiment 1
As shown in Figure 2, according to a preferred embodiment of the present invention the sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis comprises sacculus 1, sacculus inner tube 4 and the foley's tube 5 that can fill.
Wherein, Fig. 2 shows the full state of this sacculus 1, and this sacculus 1 can be compliant balloon or half compliant balloon.Sacculus inner tube 4 runs through this sacculus 1 and extends axially, wherein, the distal openings 41 straight-through diseased regions of this sacculus inner tube 4, and proximal openings 42 is connected with luer joint or rib-loop interface or horn-like interface, thus link to each other with small size vacuum pumping equipment and/or drug storage (not shown).The radial diameter of this sacculus inner tube 4 is depicted as 1mm in the present embodiment.Should be appreciated that the radial diameter of this sacculus inner tube 4 can be regulated as required, preferably between 0.5-5mm, more preferably 1-3mm guides seal wire to insert and the liquid turnover thereby make things convenient for.The distal openings 51 of foley's tube 5 ends at sacculus 1 inside, and proximal openings 52 is connected with the luer joint equally, thereby links to each other with ball inflation pressure pump.
By foley's tube 5, ball inflation pressure pump is sacculus 1 pressurising so that sacculus 1 arrives suitable full state, thereby so that diseased region strutted.Little in the middle of the sacculus 1 of this full state is depicted as, the sacculus that two is large.Compare with ZL200620161536.2 of the prior art and ZL 201020180943.4, sacculus 1 provided by the present invention can be fastened on the nasal sinuses mouth in use, and the Dou Kou tissue is carried out the excipient arrangement.Those skilled in the art is known, nasal meatus and nasal sinuses are not a concept, sacculus among the ZL200620161536.2 can be placed in the nasal meatus, but when it acts on the nasal sinuses place of usually easy inflammation, the squeezing action that only depends on the pressure of the full expansion of sacculus to bring, can only push each nasal sinuses, impossible smooth opening Dou Kou discharges the luminal sectetion thing smoothly.Different from the closed housing such as blood vessel, the nasal sinuses opening is not the long tract that diameter seamlessly transits, and hole mouth length is quite short, and one section to be opened on the hole body inner, and the other end is opened in the nasal meatus.It is stable that to open Dou Kou and make it to keep as far as possible the long enough time be the key that ensures successful surgery and therapeutic effect.ZL 201020180943.4 does not provide how to open inaccessible Dou Kou with foley's tube, even closed Dou Kou can be opened by this invention foley's tube, after external force is removed (being after sacculus is removed), the Dou Kou that opens still can be closed, is not enough to provide sufficiently long chronotherapy window.Sacculus 1 of the present invention is designed to the large middle small difference shape in full rear two, when the nasal sinuses port part is opened, can be fit to well the shape of Dou Kou, after full with nasal sinuses mouth cartilage to extrapolation, and with hole mouth excipient, Dou Kou is maintained unimpeded state more enduringly, make the hole body recover the nature physiological status.Thereby behind the hole mouth excipient, providing the time enough window for thoroughly curing nasal cavity intractable pathological changes, this is thoroughly to treat pathological changes and the key of being avoided it repeatedly to show effect.By sacculus inner tube 4, seal wire can extend into diseased region and perform the operation, and in this operation process, the secretions of diseased region excretes under the effect of vacuum draw equipment by sacculus inner tube 4 equally.After this suction was finished, by foley's tube 5, the pressure of sacculus 1 was by removal.By sacculus inner tube 4, the herbal sprinkling in the drug storage is to diseased region, so that medicine paste invests the diseased region surface.
In the present embodiment, the radical length of the mid portion of the sacculus 1 under the full state is depicted as 5mm, and the radical length of two head part is preferably than the large 5mm of radical length of mid portion.Should be appreciated that the radical length of the mid portion of the sacculus 1 under the full state can be adjusted as required, is preferably about 2 ~ 10mm, the radical length of two head part also can be adjusted as required, preferably than the about 2 ~ 20mm of the radical length of mid portion.Clinical anatomic proves that the individual variation of nose and nasal sinuses is very large.As if nose and nasal sinuses not yet reach a stable Evolutionary Levels.The adaptation of morphological function is also being proceeded.Frequent visible anatomical variation has proved this viewpoint in the part.The size of sacculus 1 is to determine according to the shape of nasal sinuses body, makes sacculus can be fit to the size of nasal sinuses mouth and nasal sinuses inside, and therefore, for being fit to different nasal sinuses shape and sizes, the size Selection of sacculus 1 is more wide in range.
To the mode of nasal cavity spraying medicine (only be no more than 30% medicinal liquid sent to diseased region), the application brings into play the therapeutical effect of medicine more effectively directly for the administration of diseased region site-directed quantitative with respect to traditional employing collunarium or spray.
Alternatively, in use, the distal openings 41 of this sacculus inner tube 4 ends in the cavity of sinus frontalis 7 or maxillary sinus 9, medicine in the drug storage is transported to by sacculus inner tube 4 in the cavity of sinus frontalis 7 or maxillary sinus 9, and the re-entrant portion of this sinus frontalis 7 or maxillary sinus 9 is as the temporary memory of medicine at this moment.
With respect to traditional employing collunarium or the spray mode (most medicinal liquid flows out along spraying the path) to the nasal cavity spraying medicine, the application is directly in the cavity with medicament storage and sinus frontalis or maxillary sinus, this medicine is along with swing and the flowing of nasal cavity mucus of nasal cavity cilium are in time delivered to diseased region continually, so that diseased region can continue to obtain Drug therapy within the sufficiently long treatment phase, significantly promote the effect of drug treatment.
Embodiment 2
As shown in Figure 3, according to a preferred embodiment of the present invention the sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis comprises the first sacculus 10, the second sacculus 20, the second foley's tube 30, sacculus inner tube 40 and first foley's tube 50 that can fill.
Wherein, Fig. 3 shows the full state of this sacculus 10, and this sacculus 10 can be compliant balloon or half compliant balloon.Sacculus inner tube 40 runs through the first sacculus 10 and the second sacculus 20 extends axially, wherein, the distal openings 410 straight-through diseased regions of this sacculus inner tube 40, and proximal openings 420 is connected with luer joint or rib-loop interface or horn-like interface, thus link to each other with the small size vacuum pumping equipment.The radial diameter of this sacculus inner tube 40 is depicted as about 3mm in the present embodiment.Should be appreciated that the radial diameter of this sacculus inner tube 40 can be regulated as required, preferably between 0.5-5mm, more preferably 1-3mm guides seal wire to insert and the liquid turnover thereby make things convenient for.
The distal openings 510 of the first foley's tube 50 ends at the first sacculus 10 inside, and proximal openings 520 is connected with the luer joint, thereby links to each other with ball inflation pressure pump.The distal openings 310 of the second foley's tube 30 ends at the second sacculus 20 inside, and proximal openings 320 is connected with the luer joint, thereby links to each other with drug storage and/or ball inflation pressure pump.
In the present embodiment, the radical length of the mid portion of the first sacculus 10 under the full state is depicted as 10mm, and the radical length of two head part is preferably than the large 5mm of radical length of mid portion.Should be appreciated that the radical length of the mid portion of the sacculus 10 under the full state can be adjusted as required, is preferably about 2 ~ 30mm, the radical length of two head part is preferably than the about 2 ~ 30mm of the radical length of mid portion.
The partial enlarged drawing of the second sacculus 20 is referring to shown in Figure 4, and the wall of the second sacculus 20 is uniform-distribution with spray medicine aperture 210, and the quantity of spray medicine aperture 210 and aperture determine according to the design of medicament categories, spray value demand and drug delivery balloon 20.For example, the quantity of this spray medicine aperture 210 is preferably at least one, is preferably more than 3.In the present embodiment, the aperture of this spray medicine aperture is depicted as 0.5mm.Should be appreciated that the aperture of this spray medicine aperture can be adjusted as required, is preferably 0.1mm-2mm, more preferably 0.5mm-1mm.
As follows according to the administering mode that two sacculus of present embodiment relate to: by the first foley's tube 50, ball inflation pressure pump is sacculus 10 pressurisings so that sacculus 10 arrives suitable full state, thereby so that diseased region strutted.By sacculus inner tube 40, seal wire can extend into diseased region and perform the operation, and in this operation process, the secretions of diseased region excretes under the effect of vacuum draw equipment.After this suction was finished, by the first foley's tube 50, the pressure of sacculus 10 was by removal.By the second foley's tube 30, the drug conveying in the drug storage is to the second sacculus 20, and medicine is sprayed onto diseased region by spray medicine aperture 210, so that medicine paste invests the diseased region surface.
As from the foregoing, the suction of the secretions of diseased region realizes by sacculus inner tube 40, and the transfer passage of medicine is realized by the second foley's tube 30, thereby has effectively reduced the pollution of medicine.In addition, the spray medicine aperture by on the second sacculus 20 can spray to the diseased region surface accurately with medicine, thereby realizes the more medication of science.
Alternatively, this second sacculus 20 is positioned at sinus frontalis 7 or maxillary sinus 9, medicine in the drug storage is transported to sinus frontalis 7 or maxillary sinus 9, and the re-entrant portion of this sinus frontalis 7 or maxillary sinus 9 makes diseased region can both obtain Drug therapy within the sufficiently long treatment phase as medicament reservoir.
The related spendable medicine of sacculus chemical spraying device of the present invention can be for liquid or solid-state.Generally liquid medicinal liquid is that the solid active drug is added in the carrying solvent, make solution, emulsion or suspension, solvent commonly used is the sodium chloride brine of mass percent concentration 0.3%-4.0%, and preferred concentration is 0.7%-0.9%, then active drug is dissolved in wherein, is mixed with medicinal liquid.The pH of saline and environment in nasal cavity are nearest under this concentration, and nose cilium optimum under this concentration and pH swings, and most of rhinitis pathological changes all is because the imbalance of nasal cavity mucus cilia motor function causes.
Solid-state medicine adopts the means such as grinding, atomizing that medicine bulky grain solid is decomposed to micron or nano_scale particle, then medicine is delivered to the affected part by device under gas pressure.In other implementations, drug microparticles may form the suspension state and by pressure vessel it is delivered to the target location with liquid.In the outstanding mixed liquid of this class, drug microparticles should be distributed in the liquid by uniformity, for reaching this purpose, should select suitable liquid, particle coagulation is dropped to minimum.Described pressure vessel divides inside and outside two-layer room, and with valve with two Room UNICOMs, suspension can be by force feed to the target location behind the valve open.
In other implementation, under normal room temperature and the atmospheric pressure, the suspension solvent is liquid condition in pressure vessel, after in case pressurized is sprayed by pressure vessel, the suspension that discharges under room temperature and atmospheric pressure is vaporized rapidly, thereby only there is drug microparticles to be taken to tissue surface, and do not have the suspension solvent.This type of typical suspension solvent comprises hydrofluoroalkane based compound (HFA), for example HFA134 and HFA227ea.
Further, the degradable controlled release polymer can be made equally micron or nano-scale particle and together be sprayed into the affected part, and then inject suitable solvent (such as the 0.7%-0.9% normal saline) to nasal cavity.Under the effect of body temperature and solvent, the swelling of degradable polymer microgranule generation swelling forms more stable slow releasing pharmaceutical coating with drug microparticles.
Above-described available medicine includes but are not limited to following listed medicine, long-acting steroids hormone, anti-inflammatory drug, anti-allergic drug, parasympatholytic, antihistaminic medicine, anti-infective, antiplatelet drug, anticoagulation, antithrombotic, anti-cicatrix medicine, antiproliferative pharmaceutical, chemotherapeutic, antineoplastic agent, the congested agent of solution, accelerator for concrescence, vitamin (as: tretinoin, vitamin A, vitamin B, and spin-off), immuno modulating agent, immunosuppressant, and the compositions of above-mentioned medicament or mixture.
Above-described slow release degradable polymer is polylactic acid and derivant thereof, copolymer, blend.Can regulate slow release and regulate degradation rate with the molecular size range of degradable polymer, and then regulate slow release speed.Slow-release time is controlled at 1 day to 90 days, and preferred slow-release time is 3 to 30 days.
A nearlyer step ground, the polymer of mixing can be for comprising 2 kinds of different microgranules at least, and every kind of microgranule is comprised of variety classes polymer or variety classes combination of polymers respectively.Typically design is, wherein a kind of microgranule is comprised of degradable polymer, and another kind of microgranule is comprised of water-soluble polymer.Degradable polymer and water-soluble polymer relative mass or relative mass and the volume of volume and the two microgranule in compositions is suitable.
Normally, make microgranule as far as possible fully cover contact and form firmly binding film at tissue surface, the microgranule in the combination is quite little.The microgranule average particle size distribution should be at 50 nanometers to 500 micron support, and perhaps particle size distribution is narrower, between 700 nanometers to 200 micron.
This class degradable polymer and water-soluble polymer, and their compositions, wherein the composition of composition is very large on quality of forming film impact, also can affect after the film forming bonding force and durability degree with tissue.In certain embodiments, the mass percent of degradable polymer or degradable polymer mixture can be 1-99,10-90,20-90,30-90,40-90,50-90,60-90,70-90,10-80,10-70,10-60,10-50,10-40,10-30,20-80,30-70, or 40-60.In certain embodiments, the mass percent of water-soluble polymer or water-soluble polymer mixture can be 10-90,20-90,30-90,40-90,50-90,60-90,70-90,10-80,10-70,10-60,10-50,10-40,10-30,20-80,30-70, or 40-60.
Degradable polymer comprises synthetic and the natural polymer that hydrolytic degradation can occur.Synthetic hydrolysis degradable polymer comprises and comprises Poly(D,L-lactide-co-glycolide (poly (L-lactide-co-glycolide) is PLGA) at interior hydrolysis degradable polyester.Typical natural degradable polymer comprises chitin.Typical water-soluble polymer comprises that Polyethylene Glycol (PEG), polyethyleneglycol block copolymer are (for example take the PEG/PLGA of Polyethylene Glycol unit as the macromolecular chain tail end, PEG/PLA diblock or triblock copolymer, or PEG/PLGA, PEG/PLA diblock or three block random copolymerizations, alternate copolymer), sucrose, starch, Algin, polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA).Polyvinyl alcohol (PVA) is a kind of typical easily hygroscopic polymer, can generation swelling and chemical degradation under the state of water arranged.The above polymer except sucrose, all has the characteristics of easy moisture absorption.
The performance of film forming caudacoria, particularly along with degraded deepens continuously, film can be adhered to keeping the time of film forming brute force and time that film is etched fully and can be controlled by adjusting in the copolymer ratio of lactide (LA) and Acetic acid, hydroxy-, bimol. cyclic ester (GA).When the mol ratio of lactide (LA) had 100% to descend gradually or rise gradually by 0%, the degree of crystallinity of copolymer was tending towards descending, and causes powerful decline.In addition, the external degradation time of known PLGA can reduce, when the mol ratio of lactide (LA) has 100% to descend gradually or rise gradually by 0%.
Above-described, be preferred embodiment of the present invention only, be not to limit scope of the present invention, the above embodiment of the present invention can also make a variety of changes.Be that simple, the equivalence that every claims according to the present patent application and description are done changes and modification, all fall into the claim protection domain of patent of the present invention.The present invention not detailed description be the routine techniques content.

Claims (9)

1. sacculus chemical spraying device that is used for the treatment of sinusitis or allergic rhinitis, this sacculus chemical spraying device comprises sacculus (1,10), the sacculus inner tube (4 that can fill, 40) and foley's tube (5,50), described sacculus inner tube (4,40) run through described sacculus (1,10) and extend axially, described foley's tube (5,50) distal openings (51,510) end in the described sacculus (1,10), it is characterized in that, described sacculus (1,10) is the large sacculus in middle little two after full.
2. sacculus chemical spraying device as claimed in claim 1 is characterized in that, the distal openings (41,410) of described sacculus inner tube (4,40) ends at diseased region, sinus frontalis and/or maxillary sinus.
3. sacculus chemical spraying device as claimed in claim 1 is characterized in that, the proximal openings (52,520) of described foley's tube (5,50) links to each other with ball inflation pressure pump.
4. sacculus chemical spraying device as claimed in claim 1 is characterized in that, the proximal openings (42,420) of described sacculus inner tube (4,40) links to each other with vacuum draw equipment and/or drug storage.
5. sacculus chemical spraying device as claimed in claim 1, it is characterized in that, this sacculus chemical spraying device also comprises the second sacculus (20) and the second foley's tube (30), the wall of described the second sacculus (20) has at least one spray medicine aperture (210), and the distal openings (310) of described the second foley's tube (30) ends in described the second sacculus (20).
6. sacculus chemical spraying device as claimed in claim 5 is characterized in that, the proximal openings (320) of described the second foley's tube (30) links to each other with the second ball inflation pressure pump and/or drug storage.
7. sacculus chemical spraying device as claimed in claim 5 is characterized in that, described spray medicine aperture (210) is distributed on the wall of described the second sacculus (20) equably.
8. sacculus chemical spraying device as claimed in claim 5 is characterized in that, the aperture of described spray medicine aperture (210) is 0.1mm-2mm.
9. sacculus chemical spraying device as claimed in claim 5 is characterized in that, described the second sacculus (20) is positioned at diseased region, sinus frontalis and/or maxillary sinus.
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