The intranasal support of self-expansion typeTechnical field
The present invention relates to the medical instruments field for the treatment of nose-nasosinusitis, relate more specifically to a kind of self-expansion type internal nasal branchesFrame.
Background technology
Nasal cavity and nasal sinus are located at below cranium brain, occupy throat with above oral cavity, being seated between two eye sockets.Nasal cavity and nasal sinusLesion often spreads to tissue around, thus can cause various complication.Usual nose-nasosinusitis is sent out in nasal cavity inspectionIt is existing, there are purulent secretion, concha nasalis media and middle nasal meatus mucosa or Polypoid changes at nasal meatus or olfactory cleft.Can to multiple nasosinusitisMake cloudy pressure auxotherpy, maxillary sinus puncture can be made to suppurative maxillary sinusitis.There are nasal polyp, middle turbinate swell, nasal septum curvedThe mechanical obstruction factor person such as song, adenoids, because hindering the ventilation and drainage of nasal sinus, make inflammation be difficult to cure, can useOnychectomy, nasal septal construction, adenoidectomy in operative treatment, such as nasal polypectomy, nose, it is more commonly used at presentOperation is conchoscope Minimally Invasive Surgery.
Nose-the sinusitis in patients undesirable to drug therapy, current the most frequently used, maximally effective treatment means are " features "Nasal sinus opening art, such as FESS, nasal sinus balloon dilatation (Balloon Sinuplasty), it is therefore an objective to naturally open heavy by nasal sinusBuild the ventilation and drainage of nasal sinus.
Operation is " feature " nasal sinus opening art, still has the position of inflammation in postoperative nasal sinus or nasal cavity, can pass through lifeManage salt solution, drug irrigation.But such treatment is of short duration, medicine is very short to inflamed sites action time, the zone of actionIt is limited, it is bad to the therapeutic effect of inflammation.And nasal sinus and nasal membrane easily occur what is be adhered in Post operation half monthSituation, normal ventilation function can be blocked by being adhered.
Therefore, it is clinical now lack a kind of effective treatment means are adhered to nose-nasosinusitis post-operation inflammatory and postoperative mucous membrane.
The content of the invention
It is an object of the invention to provide a kind of intranasal support of self-expansion type, the intranasal support is used to treat nose-nasosinusitis,After surgery by intranasal the stenter to implant lesion nasal sinus or nasal cavity, nasal sinus or nasal cavity are supported, for eliminating nasal sinus or noseThe inflammation of chamber, nasal sinus or nasal membrane is prevented to be adhered.
The invention provides a kind of intranasal support of self-expansion type, and specifically, the intranasal support is self-expansion type internal nasal branchesFrame, the intranasal support expand in its natural state, have an expansionary force that the intranasal support can be made to be close to nasal sinus during expansionOr nasal cavity inwall, while this expansionary force again will not overdistension nasal sinus or nasal cavity；The intranasal support and lesion nasal sinus are phasesConformal, the intranasal support is divided into near-end, waist and distal end under natural swelling state, wherein, the cross-sectional area of near-end isS1, the cross-sectional area of waist are S2, and the cross-sectional area of distal end is S3, and S2 ＜ S1 and S2 ＜ S3；Preferably, S2 ＜ S1 ＜ S3.
It should be noted that the intranasal support being placed in lesion nasal sinus or nasal cavity, under expansion state, it is shaped asHourglass shape or buttferfly-type etc., the cross section refer to the central axis of the intranasal support perpendicular to hourglass shape or buttferfly-type,And the cross section that sectional area is maximum.
In another preference, the expansion ratio of the intranasal support is 2-100；Preferably, 5-100；More preferably, 5-50.The expansion ratio of the intranasal support is very big, when the region that intranasal support is placed it is existing it is narrow have wide region again when, intranasal supportDue to its self-expanding performance and expansion ratio is big, can be very good to be expanded into the inwall of area above, and support area above.
In another preference, the intranasal support is used for nasal sinus (including sinus frontalis, maxillary sinus, sphenoid sinus, the sieve for treating lesionSinus) and nasal cavity, the sinus frontalis being particularly generally not easily accessible to for medicine.
In another preference, the length L1 of the intranasal support is 10-160mm；Preferably, 15-150mm；More preferably,20-100mm。
In another preference, diameter D1 >=10mm of the maximum of the intranasal support, it is preferable that 15-30mm, more preferablyGround, 15-20mm.
In another preference, diameter D2 >=4mm at the minimum of the intranasal support, it is preferable that 8-15mm, more preferablyGround, 8-10mm.
In another preference, the waist of the intranasal support is provided with flat segments, and the length of the flat segments is that L2 is 0mm＜ L2 ＜ L1；More preferably, 5mm ＜ L2 ＜ L1；More preferably 5mm ＜ L2 ＜ L1-5mm.
Can be straight line connection when a diameter of D2 region is connected with a diameter of D1 region in another preference,It can be circular sliding slopes, can also be and be attached with other arbitrary shapes.
It should be noted that the cross section of the intranasal support can be arbitrary shape, it is therefore preferable to circular or ellipse, instituteThe diameter D2 stated at the diameter D1 and minimum of the maximum of intranasal support is by the area equivalent of the cross section of the intranasal supportFor the diameter corresponding to the circle of same area.
In another preference, when a diameter of D2 region is attached with a diameter of D1 region by straight line, meetingAn angle α is formed, wherein, 0 ° of 90 ° of ＜ α ＜；Preferably, 10 ° of 80 ° of ＜ α ＜；More preferably, 20 ° of 70 ° of ＜ α ＜.
It is bent when a diameter of D2 region is attached with a diameter of D1 region by curved surface in another preferenceTangent line and horizontal line angle at each point of line are β, wherein, 0 ° of 90 ° of ＜ β ＜；Preferably, 10 ° of 80 ° of ＜ β ＜；More preferablyGround, 20 ° of 70 ° of ＜ β ＜.
In another preference, in the expanded state, intranasal support is symmetrical on axis or some section ruleShape.
In another preference, in the expanded state, intranasal support be adapt to lesion nasal sinus or nasal cavity it is substandardShape.
In another preference, the intranasal support enters from nasal cavity, and is pushed into the nasal sinus of lesion or nasal cavity.
In another preference, the intranasal support is under the not swelling state by external force pressure, its waist cross-sectional areaIt is more than twice of Dou Kou sections.
In another preference, the intranasal support is the shape that the big centre in two is small under expansion state, such as：ButterflyJunction type, hourglass shape, I-shaped etc..Such shape can allow the intranasal support not moved to well positioned at nasal sinus Dou KouOther positions, so accurately the diseased region of drug therapy can be needed to be administered.
In another preference, the intranasal support is biocompatible material, and is degradable.
In another preference, most of or even all degradation material of the intranasal support, only sub-fractionOr without metal material.
In another preference, the accounting of the degradation material in the intranasal support is 90%-100%.
In another preference, the intranasal support is poly-lactic acid material.After the intranasal stenter to implant human body of these materials,Final degraded adult body can metabolism material, it is nontoxic to human body, without accumulation, after so intranasal stenter to implant human body, finallyDegrade adult body can metabolism material.
In another preference, the intranasal support is attached with medicine, and the medicine is used to treat inflammation.
In another preference, the nasal sinus or nasal cavity tissue abutting contact of intranasal support and lesion, carry on intranasal supportMedicine be slowly diffused into the tissue of nasal sinus and nasal cavity, treatment has the region of inflammation.
In another preference, intranasal support carries medicine, and the medicine on intranasal support will not be lost in out of human body quickly,Enough long-times can be stopped in human body internal memory, can be spread to the pathological tissues for needing anti-inflammatory, ensure medicine effectively to diseased regionTreat in domain.
In another preference, medicine can be anti-inflammation drugs, such as antibiotic (such as gentamicin)；It can also be hormoneClass medicine (such as dexamethasone)；It can also be mucus diluent (myrtol, eucalyptol, limonene and australene).
In another preference, the internal nasal branches, which is set up, load medicine body, and the load medicine body is used to store the medicine, describedIt is following any structure or its combination to carry medicine body：Carry medicine hole, medicine-carrying trough and coating.
In another preference, the quantity of the coating is one or more layers, and coating described in multilayer is used to be loaded with a variety of medicinesThing.
In another preference, the intranasal support is hollow structure, and the side wall of the intranasal support is engraved structure, non-Void region includes girder and connecting rod；The quantity of the girder is n, wherein, 3≤n≤50, the girder be shaped as withLower any shape or its combination：Linear pattern, U-shaped, V-type, M types, W types, sine curve or irregular shape；The adjacent girder itBetween connected by the connecting rod；Void region is shaped as following any shape or its combination：Square, rectangle, circle,Rhombus, shuttle-type, irregular shape.
In another preference, the wall thickness of the intranasal support is 0.01-2mm；Preferably, 0.05-0.2mm.
In another preference, the width of the girder is 0.01-2mm；Preferably, 0.05-0.2mm.
In another preference, the connecting rod is attached to the optional position of the girder.
In another preference, the intranasal support includes being used for the delivery conduit for compressing the intranasal support.
In another preference, the delivery conduit is hollow elongated tubular, and in an initial condition, the intranasal support is retractedIn the inner chamber of the hollow elongated tubular.
In another preference, the delivery conduit is a pebax pipe.
In another preference, the outer layer of the delivery conduit is pebax pipes, and internal layer is PTFE tube.
In another preference, the outer layer of the delivery conduit is pebax pipes, and internal layer is PTFE tube and tube wall is embedded withMetal (such as stainless steel) silk or metal (such as stainless steel) woven tube.
In another preference, the afterbody of the delivery conduit sets a catheter block, is held for operator by delivery conduitWhen operation (such as push-and-pull, rotation delivery conduit) it is convenient.
In another preference, the external diameter of the delivery conduit is less than 4mm, more preferably, less than 2.5mm.
In another preference, the internal diameter of the delivery conduit is more than 2mm, more preferably, more than 1mm.
In another preference, the effective length of the delivery conduit is not less than 140mm.
In another preference, the intranasal support includes guiding catheter, by guiding catheter, will shrink standoff defeatedConduit is sent to be transported to lesion nasal sinus or nasal region.
It should be understood that within the scope of the present invention, above-mentioned each technical characteristic of the invention and have in below (eg embodiment)It can be combined with each other between each technical characteristic of body description, so as to form new or preferable technical scheme.As space is limited, existThis no longer tires out one by one states.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to embodiment or existingThere is the required accompanying drawing used in technology description to do and simply introduce, it should be apparent that, drawings in the following description are only thisSome embodiments of invention, for those of ordinary skill in the art, on the premise of not paying creative work, can be withOther accompanying drawings are obtained according to these accompanying drawings.
Fig. 1-1a, Fig. 1-2 a, Fig. 1-3a, Fig. 1-4a, Fig. 1-5a, Fig. 1-6a, Fig. 1-7a are in an example of the inventionThe front view of the intranasal support of self-expansion type in expansion state；
Fig. 1-1b, Fig. 1-2 b, Fig. 1-3b, Fig. 1-4b, Fig. 1-5b, Fig. 1-6b, Fig. 1-7b are in an example of the inventionThe dimensional drawing of the intranasal support of self-expansion type in expansion state；
Wherein, Fig. 1-1a are corresponding with Fig. 1-1b, and Fig. 1-2 a and Fig. 1-2 b are corresponding, Fig. 1-3a and Fig. 1-3bIt is corresponding, Fig. 1-4a and Fig. 1-4b are corresponding, and Fig. 1-5a and Fig. 1-5b are corresponding, and Fig. 1-6a and Fig. 1-6b areCorresponding, Fig. 1-7a and Fig. 1-7b are corresponding.
Fig. 2 is the front view of the guiding catheter in an example of the invention.
Fig. 3 is the structural representation that the intranasal support in an example of the invention is contracted in delivery conduit.
Fig. 4 is the structural representation of the girder of the intranasal support in an example of the invention.
Fig. 5 a are the structural representations of the intranasal support of the pass load medicine in an example of the invention.
Fig. 5 b are the structural representations of the intranasal support of the medicine-carrying trough type load medicine in an example of the invention.
Fig. 5 c are the profiles of the intranasal support of the coating type load medicine in an example of the invention.
Fig. 6 is schematic diagram of the guiding catheter in an example of the invention into nasal sinus.
Fig. 7 is that the intranasal support in an example of the invention is contracted in delivery conduit and enters lesion along guiding catheterThe structural representation of position.
Fig. 8 is the delivery conduit recession in an example of the invention, and intranasal support stretches out delivery conduit and starts self-expandingStructural representation.
Fig. 9 is the fully extended delivery conduit of intranasal support in an example of the invention and expanse be close to nasal sinus area withStructural representation.
It is external that Figure 10 is that guiding catheter, delivery conduit and the push rod in an example of the invention are removed, and support stays in nasal cavityInterior structural representation.
In each accompanying drawing, each sign is as follows：
1- supports；
2- guiding catheters；
3- delivery conduits；
4- push rods；
5- girders；
6- carries medicine hole；
7- medicine-carrying troughs.
Embodiment
The present inventor, by largely screening, it is intranasal to develop a kind of self-expansion type first by in-depth study extensivelySupport, compared with prior art, the intranasal support of self-expansion type of the invention is self-expanding, after inserting the nasal sinus or nasal cavity of lesionCan be according to the size self-expansion of placement location, and it is close to nasal sinus or nasal cavity inwall, adapt to the nasal sinus and nasal cavity structure of complexity；Support is the small shape in the big centre in two under expansion state, such as hourglass shape, I-shaped, dog bone shape.Such shapeSupport can be allowed not move to other positions positioned at nasal sinus Dou Kou well, so accurately can be needed drug therapyDiseased region is administered；In addition, the support of the present invention is degradable, medicine is attached with support, medicine can treat inflammation, preventOnly nasal cavity or nasal sinus mouth are adhered, and support is compressed into a size of very little by delivery conduit in vitro, exists beneficial to supportWalked in tiny nasal cavity or nasal sinus, complete the present invention on this basis.
The invention provides a kind of intranasal support of self-expansion type, and it is a kind of self-expansion type internal nasal branches with specific structureFrame.The intranasal support wall thickness 0.01-2mm of self-expansion type of the present invention；Preferably, 0.05-0.2mm, support is engraved structure, non-to engraveDummy section is the girder of a rule, and the width of girder is 0.01-2mm；Preferably, 0.05-0.2mm, the shape of girder can beAny one or more of the various line styles such as linear pattern, U-shaped, V-type, M types, W types, sine curve or irregular shape.By connectingBar links together adjacent girder, and connecting rod is connected to the optional position of girder when connecting adjacent girder.Void regionShape can be any one or more variously-shaped such as square, rectangle, circle, rhombus, shuttle-type, irregular shape.
Support can self-expansion in its natural state.There is an expansionary force can be so that support is close to nasal sinus or nose during expansionCavity wall, while this expansionary force again will not overdistension nasal sinus or nasal cavity.
Under expansion state, support can be straight tube shape, and its divergence ratio is very big, so, when the region that support is placedExisting narrow when having wide region again, support is due to its self-expanding performance and divergence ratio is big, can be very good to be expanded to above areaThe inwall in domain, and support area above.
Support can also be the small shape in the big centre in two, such as hourglass shape, I-shaped, dog bone shape under expansion stateShape.Such shape can allow support not move to other positions positioned at nasal sinus Dou Kou well, so can accurately giveThe diseased region of drug therapy is needed to be administered.
Total stent length is L1, maximum outside diameter D1.When support is not straight barrel type, its waist can be smaller than two, branchA diameter of D2 at frame minimum；If waist also has flat segments, the length of straight waist is L2；A diameter of D2 regions with it is a diameter ofDuring D1 region connection, it can be straight line connection or circular sliding slopes, can also be the connection of other arbitrary shapes；BranchFrame can be on axis or the symmetrical shape of some section rule or substandard shape.
The overall length L1 of support can be 10-60mm；Preferably, 15-50mm；More preferably, 20-40mm.
The maximum outside diameter D1 of support can be >=10mm；Preferably, 15-30mm；More preferably 15-20mm.
Diameter D2 at support minimum can be >=4mm；Preferably, 8-15mm；More preferably 8-10mm.
Waist is straight, and length L2 can be 0mm ＜ L2 ＜ L1；Preferably, 5mm ＜ L2 ＜ L1；More preferably, 5mm ＜ L2 ＜L1-5mm。
Connection diameter is D2 regions when with a diameter of D1 region being that straight line is connected, and can form an angle α between line, 0 °90 ° of ＜ α ＜；Preferably, 10 ° of 80 ° of ＜ α ＜；More preferably, 20 ° of 70 ° of ＜ α ＜.
Medicine can be adhered on support, support, with nasal sinus or nasal cavity tissue abutting contact, is carried on support under expansion stateMedicine be slowly diffused into the tissue of nasal sinus and nasal cavity, treatment has the region of inflammation.Medicine can be anti-inflammation drugs, such as antibiosisPlain (such as gentamicin)；Can also be hormone medicine (such as dexamethasone)；It can also be mucus diluent (hill gooseberryOil, eucalyptol, limonene and australene).
Medicine adhering mode：In the load medicine hole that can have been carved on support；The load medicine that can also have been carved on supportIn groove.It can also be and be uniformly blended in support in itself or in the coating of rack surface, the support can have one or more layers, canTo be loaded with multi-medicament.
Support can be the materials such as PLA or metal alloy.When support is in itself PLA, can be dropped in human bodySolution.PLA is directly degraded to carbon dioxide and water in human body, can be absorbed by the body or drain, nontoxic to human body, without accumulation.So after stenter to implant human body, it is final degrade adult body can metabolism material.
Medicine so on support will not both be lost in out of human body quickly；And the time that medicine retains in human body is enoughIt is long, the pathological tissues for needing anti-inflammatory are can be spread to, ensure medicine effectively to lesion region continued treatment.
The intranasal support of the present invention includes a delivery conduit for being used to shrink support.It is a hollow elongated tubular, supportIt is contracted in the hollow elongated tubular inner chamber.Its material can be a pebax pipe；Can also be that outer layer pebax is managed, internal layer PTFE tube；It can also be that outer layer pebax is managed, internal layer PTFE tube, and tube wall is embedded with metal (such as stainless steel) silk or metal (such as stainless steel)Woven tube.Its afterbody can have a catheter block.The external diameter of delivery conduit should be less than 4mm, more preferably, less than 2.5mm；Internal diameter is bigIn 2mm, more preferably, more than 1mm.The effective length of delivery conduit is not less than 140mm.
During the use of intranasal support, support press in advance it is small be contracted in delivery conduit, support carry medicine.
The intranasal support of the present invention also includes guiding catheter.By guiding catheter, it is defeated that standoff delivery conduit will be shunkIt is sent to lesion nasal sinus or nasal region.
Especially, when support is released, can be connected by a push rod, the push rod with support, can alsoIt is separate with support.When push rod is connected with support, there is a releasable in the place that push rod is connected with supportPart.Push rod and support are freed by the part.Ways of relief can be that electrolysis is taken off, machinery is freed.
When electrolysis is de-：Push rod has one to free place close to support, frees place's naked layer, conductive fusing.
When machinery is freed：It is hollow among push rod, has one to free bar among push rod.The front end for freeing bar can be bulletProperty lug or wedge lock block.Elastic lug projection clamping support afterbody, bar recession is freed when to be freed, and elastic lug occursElastic deformation departs from so as to which support is freed with support afterbody.Wedge lock block is embedded in push rod and the gap at support afterbody assemblingIn, clamping support；When freeing, bar recession is freed, wedge lock block departs from from the gap at assembling, so as to which support is freed.
, can be when support be to when needing the position placed when push rod and during support independence, push rod is from delivery conduit afterbodyChamber and forward impelling are inserted into the inner, eyelid retractor is then released constrictor inner chamber.
Push rod is connected with support is connected to an advantage, i.e., can when finding that backing positions are not ideal and also needing to adjust againSo that support is retracted in delivery conduit again, then support can be released to suitable position again and supported after adjustment positionNasal sinus or nasal cavity inwall.
The technology implementation process of the intranasal support of self-expansion type of the present invention is：
A) suitable guiding catheter is selected, reaches the nasal sinus or nasal region of lesion.
B) by push rod by support toward drawing in delivery conduit, by stent collapses to delivery conduit, pass through guiding catheter, willShrink standoff delivery conduit and be transported to lesion nasal sinus or nasal region.
C) after reaching lesion region, delivery conduit recession, by push rod by outside stent pushing to delivery conduit, support it is remoteFirst expanded because self-expanding acts at end.
D) support after expanding is close to nasal sinus or nasal cavity inwall.The support of the small shape in the big centre in two is located at nasal sinus Dou Kou,The major part at support both ends is located at the interior exocoel of nasal sinus mouth respectively, and support waist is fixed and is clamped at nasal sinus mouth.
E) push rod, delivery conduit, guiding catheter are withdrawn from, support is stayed in human body, and operation is completed.
Main advantages of the present invention include：
(a) nasal sinus or nasal cavity tissue of intranasal support abutting contact lesion under expansion state, intranasal support are that two is bigMiddle small shape so that intranasal support can be very good not moving to other positions positioned at nasal sinus Dou Kou, so can essenceTrue is needed the diseased region of drug therapy to be administered.
(b) intranasal support is degradable material, after human body is implanted into, it is final degrade adult body can metabolism material,It is nontoxic to human body, without accumulation.
(c) medicine is attached with intranasal support, the medicine can be used for treating inflammation, and medicine will not flow out of human body quicklyLose, enough long-times can be stopped in human body internal memory, can be spread to the pathological tissues for needing anti-inflammatory, ensure medicine effectively to lesionTreat in region.
(d) intranasal support can be contracted to a size of very little by delivery conduit in vitro, beneficial to intranasal support tinyNasal cavity or nasal sinus in walk.
Therefore, the present invention effectively treatment nose-nasosinusitis, after surgery by intranasal the stenter to implant lesion nasal sinus or nasal cavity,Nasal sinus or nasal cavity are supported, for preventing nasal sinus or nasal membrane to be adhered.
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate the present inventionRather than limitation the scope of the present invention.In addition, accompanying drawing is schematic diagram, therefore apparatus of the present invention and equipment are not shown by describedSize or the ratio limitation of intention.
It should be noted that in the claim and specification of this patent, such as first and second or the like relationTerm is used merely to make a distinction an entity or operation with another entity or operation, and not necessarily requires or implyAny this actual relation or order be present between these entities or operation.Moreover, term " comprising ", "comprising" or itsAny other variant is intended to including for nonexcludability so that process, method, article including a series of elements orEquipment not only includes those key elements, but also the other element including being not expressly set out, or also include for this process,Method, article or the intrinsic key element of equipment.In the absence of more restrictions, wanted by what sentence " including one " limitedElement, it is not excluded that other identical element in the process including the key element, method, article or equipment also be present.
Embodiment
The intranasal support of self-expansion type of the present embodiment can be used for treatment lesion nasal sinus (including sinus frontalis, maxillary sinus, sphenoid sinus,Sieve sinus) and nasal cavity, the sinus frontalis being particularly generally not easily accessible to for medicine.
The intranasal support 1 of the present embodiment is the intranasal support of self-expansion type, and the intranasal support 1 in its natural state can be voluntarily swollenIt is swollen, there is an expansionary force that internal nasal branches frame 1 can be made to be close to nasal sinus or nasal cavity inwall during expansion, while this expansionary force again will not mistakeDegree expansion nasal sinus or nasal cavity, and intranasal support 1 and lesion nasal sinus are conformal.
Intranasal support 1 is the shape that the big centre in two is small under expansion state, such as：Butterfly structure, hourglass shape are I-shapedDeng.Such shape can allow intranasal support 1 not move to other positions positioned at nasal sinus Dou Kou well, so can be accurateTo being needed the diseased region of drug therapy to be administered.
The expansion ratio of intranasal support 1 is very big, when the region that intranasal support 1 is placed it is existing it is narrow have wide region again when, noseInner support 1 is due to its self-expanding performance and expansion ratio is big, can be very good to be expanded into the inwall of area above, and support above areaDomain.The expansion ratio of the intranasal support 1 of the present embodiment is 20.
Intranasal support 1 is hollow structure, and the side wall of intranasal support 1 is engraved structure, and non-void region includes girder 5 and connectedExtension bar.The structure of girder 5 as shown in figure 4, the quantity of girder 5 is n in an intranasal support 1, wherein, 3≤n≤50, girder 5Be shaped as V-type；Connected between adjacent girder 5 by connecting rod, connecting rod is attached to the optional position of girder 5；Vacancy sectionDomain is shaped as rhombus.The wall thickness of intranasal support is 0.1mm, and the width of girder is 0.1mm.
Such as Fig. 1-1a to Fig. 1-7b, intranasal support 1 under expansion state, its nasal sinus for being shaped as adapting to lesion or nasal cavityThe small shape in the big centre in two, such as：Butterfly structure, hourglass shape, I-shaped etc..Such shape can allow intranasal support 1 veryGood does not move to other positions positioned at nasal sinus Dou Kou, so can accurately to need the diseased region of drug therapy toMedicine.
Wherein, the length L1 of intranasal support 1 is 10-160mm；Preferably, 15-150mm；More preferably, 20-100mm；It is intranasalDiameter D1 >=10mm of the maximum of support 1, it is preferable that 15-30mm, more preferably, 15-20mm；Minimum at diameter D2 >=4mm；Preferably, 8-15mm；More preferably 8-10mm；Waist is straight, and length L2 can be 0mm ＜ L2 ＜ L1；Preferably, 5mm ＜ L2＜ L1；More preferably, 5mm ＜ L2 ＜ L1-5mm.A diameter of D2 region is when being connected by straight line, even with a diameter of D1 regionAn angle α, 0 ° of 90 ° of ＜ α ＜ can be formed between line；Preferably, 10 ° of 80 ° of ＜ α ＜；More preferably, 20 ° of 70 ° of ＜ α ＜.A diameter of D2Region and a diameter of D1 region be by circular sliding slopes.A diameter of D2 region and a diameter of D1 region pass through circular arcWhen being attached, tangent line and horizontal line angle at each point of circular curve are β (not shown), wherein, 0 ° of ＜ β ＜90°；Preferably, 10 ° of 80 ° of ＜ β ＜；More preferably, 20 ° of 70 ° of ＜ β ＜.
It should be noted that the cross section of intranasal support can be arbitrary shape, it is therefore preferable to circular or ellipse, internal nasal branchesIt by the area equivalent of the cross section of intranasal support is same area that diameter D2 at the diameter D1 of the maximum of frame and minimum, which is,Diameter corresponding to circle.
Intranasal support 1 is biocompatible material, and is degradable.The material of the intranasal support 1 of the present embodiment is poly- breastSour material.After the intranasal support 1 of such a material is implanted into human body, it is final degrade adult body can metabolism material, to human body withoutPoison, without accumulation, after so intranasal support 1 is implanted into human body, it is final degrade adult body can metabolism material.
Intranasal support 1 is attached with medicine, and medicine is used to treat inflammation.Nose of the intranasal support 1 under expansion state with lesionSinus or nasal cavity tissue abutting contact, the medicine carried on intranasal support 1 are slowly diffused into the tissue of nasal sinus and nasal cavity, and treatment hasThe region of inflammation.Medicine on intranasal support 1 will not be lost in out of human body quickly, can stop enough long-times in human body internal memory, canTo be diffused into the pathological tissues for needing anti-inflammatory, ensure that medicine is effectively treated to lesion region.Medicine can be anti-inflammation drugs, such asAntibiotic (such as gentamicin)；Can also be hormone medicine (such as dexamethasone)；It can also be mucus diluent (peach goldMa's oil, eucalyptol, limonene and australene).
Intranasal support 1, which is provided with, carries medicine body, carries medicine body and is used to store medicine.As shown in Figure 5 a, the load medicine body of intranasal support 1 isMedicine hole 6 is carried, storage medicine can be loaded by carrying in medicine hole 6, medicine is used to treat inflammation.
In another preference, as shown in Figure 5 b, load medicine body is medicine-carrying trough 7.
In another preference, as shown in Figure 5 c, load medicine body is coating, i.e., scribbles load medicine in the outer surface of intranasal supportLayer, the quantity of drug-loaded layer has no particular limits, and can be as needed one or more layers, for loading a variety of different pharmaceuticals.It is three layers in the present embodiment, hospital loads three kinds of medicines.
As shown in figure 3, the present embodiment is additionally provided with delivery conduit 3, in vitro, intranasal support 1 is retracted by delivery conduit 3To the size of very little, walked beneficial to intranasal support 1 in tiny nasal cavity or nasal sinus.
Delivery conduit 3 is hollow elongated tubular, and in an initial condition, intranasal support 1 is retracted in the inner chamber of hollow elongated tubular.ConveyingConduit 3 is a pebax pipe.The external diameter of delivery conduit 3 is 2mm, internal diameter 1.5mm.The effective length of delivery conduit 3 is160mm。
As shown in Fig. 2 the present embodiment is additionally provided with guiding catheter 2, by guiding catheter 2, there is the defeated of intranasal support 1 by shrinkingConduit 3 is sent to be transported to lesion nasal sinus or nasal region.
In specific implementation process, suitable guiding catheter 2 is first selected, is sent to the nasal sinus or nasal region of lesion(as shown in Figure 6)；Then support 1 is drawn toward delivery conduit 3 is interior by push rod 4, support 1 is contracted in delivery conduit 3, passed throughGuiding catheter 2, the delivery conduit 3 that contraction has support 1 is transported to lesion nasal sinus or nasal region (as shown in Figure 7)；Reach diseaseAfter becoming region, delivery conduit 3 is dropped back, and support 1 is pushed to outside delivery conduit 3 by push rod 4, and the distal end of support 1 is due to from swollenIt is swollen effect and first expanded (as shown in Figure 8)；Support 1 after expansion is close to nasal sinus or nasal cavity inwall, the small shape in the big centre in twoThe support of shape is located at nasal sinus Dou Kou, and the major part at the both ends of support 1 is located at the interior exocoel of nasal sinus mouth respectively, and support waist is fixed into clampingAt nasal sinus mouth (as shown in Figure 9)；Finally push rod 4, delivery conduit 3, guiding catheter 2 are withdrawn from, support 1 is stayed in human body, handArt completes (as shown in Figure 10).
All it is incorporated as referring in this application in all documents that the present invention refers to, it is independent just as each documentIt is incorporated as with reference to such.In addition, it is to be understood that after the above-mentioned instruction content of the present invention has been read, those skilled in the art canTo be made various changes or modifications to the present invention, these equivalent form of values equally fall within the model that the application appended claims are limitedEnclose.