CN107898540A - The sub-assembly of nasal sinus foley's tube and the intranasal stent of balloon-expandable - Google Patents

The sub-assembly of nasal sinus foley's tube and the intranasal stent of balloon-expandable Download PDF

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Publication number
CN107898540A
CN107898540A CN201710909491.5A CN201710909491A CN107898540A CN 107898540 A CN107898540 A CN 107898540A CN 201710909491 A CN201710909491 A CN 201710909491A CN 107898540 A CN107898540 A CN 107898540A
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CN
China
Prior art keywords
sacculus
stent
balloon
nasal
foley
Prior art date
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Granted
Application number
CN201710909491.5A
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Chinese (zh)
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CN107898540B (en
Inventor
付亮辉
沈碧峰
朱大伟
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ENIDE MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.
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Ling Xiu Biotechnology (shanghai) Co Ltd
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Priority to CN201710909491.5A priority Critical patent/CN107898540B/en
Publication of CN107898540A publication Critical patent/CN107898540A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Abstract

The invention discloses a kind of nasal sinus foley's tube and the sub-assembly of the intranasal stent of balloon-expandable, and specifically, which includes the intranasal stent of balloon-expandable, and intranasal stent is expanded or shunk under external force, itself is without expansion or the ability shunk;Intranasal stent and lesion nasal sinus are conformal, and intranasal stent is divided into near-end, waist and distal end under expansion state, wherein, the cross-sectional area of near-end is S1, and the cross-sectional area of waist is S2, the cross-sectional area of distal end is S3, and S2 < S1 and S2 < S3;And nasal sinus foley's tube, the front end of foley's tube are equipped with n sacculus, wherein, 1≤n≤3.Specifically, sub-assembly of the invention is used to treat nasosinusitis, after surgery by the intranasal stenter to implant lesion nasal sinus of balloon-expandable or nasal cavity, nasal sinus or nasal cavity is supported, for eliminating the inflammation of nasal sinus or nasal cavity, prevent nasal sinus or nasal membrane to be adhered.

Description

The sub-assembly of nasal sinus foley's tube and the intranasal stent of balloon-expandable
Technical field
The present invention relates to treatment nose-nasosinusitis medical instruments field, relate more specifically to a kind of nasal sinus foley's tube and The sub-assembly of the intranasal stent of balloon-expandable.
Background technology
Nasal cavity and nasal sinus are located at cranium brain in the following, occuping throat with above oral cavity, being seated between two eye sockets.Nasal cavity and nasal sinus Lesion is often spread to tissue around, thus can cause various complication.Usual nose-nasosinusitis is sent out in nasal cavity inspection It 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 nasosinusitis Make cloudy pressure auxotherpy, maxillary sinus puncture can be made to suppurative maxillary sinusitis.There are nasal polyp, middle turbinate swell, the nasal septum curved The mechanical obstruction factor person such as song, adenoids, because hindering the ventilation and drainage of nasal sinus, makes inflammation be difficult to cure, can use Onychectomy, nasal septal construction, adenoidectomy in operative treatment, such as nasal polypectomy, nose, it is more commonly used at present Operation is conchoscope Minimally Invasive Surgery.
Nose-the sinusitis in patients undesirable to drug therapy, current the most frequently used, most 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 sinus Build 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 life Manage brine, drug irrigation.But such treatment is of short duration, medicine is very short to inflamed sites action time, the zone of action It is limited, it is bad to the therapeutic effect of inflammation.And nasal sinus and nasal membrane easily occur what is be adhered in half month after performing the operation Situation, 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 nasal sinus foley's tube and the sub-assembly of the intranasal stent of balloon-expandable, the group Component is used to treat nose-nasosinusitis, after surgery by the intranasal stenter to implant lesion nasal sinus of balloon-expandable or nasal cavity, to nasal sinus or Nasal cavity is supported, and for eliminating the inflammation of nasal sinus or nasal cavity, prevents nasal sinus or nasal membrane to be adhered.
A kind of sub-assembly of the intranasal stent of nasal sinus foley's tube and balloon-expandable is provided in the first aspect of the present invention, Specifically, which includes the intranasal stent of balloon-expandable, and the intranasal stent is expanded or shunk under external force, itself Without expansion or the ability shunk;The intranasal stent is conformal with lesion nasal sinus or nasal cavity, and the intranasal stent exists Under expansion state, it is divided into near-end, waist and distal end, wherein, the cross-sectional area of near-end is S1, and the cross-sectional area of waist is S2, far The cross-sectional area at end is S3, and S2 < S1 and S2 < S3;Preferably, S2 < S1 < S3;And nasal sinus foley's tube, the sacculus The front end of conduit is equipped with n sacculus, wherein, 1≤n≤3.
It should be noted that the intranasal stent being placed in lesion nasal sinus or nasal cavity, under expansion state, its shape is Hourglass shape or buttferfly-type etc., the cross section refer to the central axis of the intranasal stent perpendicular to hourglass shape or buttferfly-type, And the cross section of sectional area maximum.
In another preference, the foley's tube is equipped with pressurization mouth, and the pressurization mouth, which is used to pressurize, expands the sacculus.
In another preference, the intranasal stent is biocompatible material, and is degradable;The intranasal stent is Any material or its combination below:Magnesium alloy, ferrous alloy and polylactic acid.After the intranasal stenter to implant human body of these materials, most Final decline solution adult body can metabolism material, it is nontoxic to human body, without accumulation.
In another preference, the quantity of the sacculus is 1, and the sacculus matches with the intranasal stent, described Sacculus is non-compliance or semi-compliant, and the sacculus is high pressure sacculus.
In another preference, the quantity of the sacculus is 2, and the sacculus is double-layered balloon, the double-layered balloon point For internal layer sacculus and outer layer sacculus;The internal layer sacculus is high pressure sacculus, and the outer layer sacculus is low pressure sacculus.
In another preference, the pressure voltage of the internal layer sacculus is P1, wherein, 2ATM≤P1≤30ATM;Preferably, 2ATM≤P1≤20ATM;The internal layer sacculus is non-compliance or semi-compliant sacculus, for expanding the Dou Kou of lesion, institute Internal layer sacculus is stated under expansion state, the outer layer sacculus and the intranasal stent are strutted by the internal layer sacculus.The internal layer The deformation quantity of sacculus is limited, size is stablized relatively.
In another preference, the material of the internal layer sacculus is following any material:Pebax, Nylon, PET etc..
In another preference, the outer layer sacculus is under expansion state, its deformation quantity is big, moulding ability is strong, to not having The zone broadening of obstacle, it is adaptable, adapt to the nasal sinus and nasal cavity structure of complexity.
In another preference, the volume of the outer layer sacculus increases with the increase of pressure, and usual volume is relatively low Pressure under can change very big, balloon volume change is up to 100-600%.
In another preference, in operation, the internal layer sacculus is first easily inserted into the expanded, and then the outer layer sacculus is again It is easily inserted into the expanded.
In another preference, in operation, the internal layer sacculus and the outer layer sacculus are expanded at the same time.
In another preference, the foley's tube is equipped with two pressurization mouths, is internal layer sacculus pressurization mouth and outer layer respectively Sacculus pressurization mouth, the internal layer sacculus pressurization mouth are used to pressurize to the internal layer sacculus, and the outer layer sacculus pressurization mouth is for giving The outer layer sacculus pressurization.
In another preference, the foley's tube is equipped with a pressurization mouth, the pressurization mouth to the internal layer sacculus and The outer layer sacculus pressurizes at the same time.
In another preference, the pressure-resistant of the outer layer sacculus is P2, wherein, P2≤2ATM;Preferably, P2≤ 0.5ATM, the outer layer sacculus is compliant balloon, for expanding the intranasal stent so that the intranasal stent is more bonded The inner cavity of lesion.During the balloon expandable with big deformability and moulding ability it is strong, to no obstacle region expand , it is adaptable.
In another preference, the material of the outer layer sacculus is following any material:The thermoplastic elastic such as silica gel or TPU Body.
In another preference, the quantity of the sacculus is 3, is distal balloon catheter, middle sacculus and proximal balloon respectively, Three sacculus are cascaded structures.
In another preference, the middle sacculus is non-compliance or semi-compliant, for expanding the Dou Kou of lesion And the stent outside middle sacculus;The distal balloon catheter and the proximal balloon are compliant balloons, for expanding Dou Kou's Stent outside interior exocoel and both ends.So as to expand the both ends of intranasal stent so that intranasal stent can be positioned without moving Depart from from Dou Kou.
In another preference, the quantity of the sacculus is 1, and the sacculus is non-compliance or semi-compliant sacculus; The center section diameter dimension of the sacculus is smaller, for expanding the Dou Kou of lesion and pressure is held in institute outside the middle sacculus State intranasal stent;The both ends size of the sacculus is larger, for expand Dou Kou interior exocoel and pressure be held in the distal balloon catheter and The intranasal stent outside the proximal balloon.So as to expand the both ends of intranasal stent so that intranasal stent can position and It will not move.
In another preference, the foley's tube is equipped with three pressurization mouths, is distal balloon catheter pressurization mouth, intermediate respectively Capsule pressurization mouth and proximal balloon pressurization mouth, the distal balloon catheter pressurization mouth are used to pressurize to the distal balloon catheter, the intermediate Capsule pressurization mouth is used to pressurize to the middle sacculus, and the near-end pressurization mouth is used to pressurize to the proximal balloon.
In another preference, the foley's tube is equipped with two pressurization mouths, is both ends sacculus pressurization mouth and centre respectively Sacculus pressurization mouth, the both ends sacculus pressurization mouth are used to pressurize to the distal balloon catheter and the proximal balloon, the intermediate Capsule pressurization mouth is used to pressurize to the middle sacculus.
In another preference, the sub-assembly includes guiding catheter and guiding seal wire.
A kind of application method of the intranasal stent of balloon-expandable is provided in the second aspect of the present invention, specifically, is somebody's turn to do Method includes:
A) sub-assembly as described above is provided;
B) sacculus of the foley's tube possesses the intranasal stent for the appearance face pressure of unexpanded state and the sacculus, The guiding seal wire is placed in the foley's tube, and the foley's tube is placed in the guiding catheter;
C) guiding catheter is sent to lesion sinus areas;
D) the guiding seal wire is promoted to go deep into lesion sinus areas;
E) foley's tube is promoted along the seal wire, and the sacculus for possessing the intranasal stent will be pressed to be pushed into lesion Sinus areas;
F) pressurize and expand to the sacculus, the intranasal stent is close in the sinus cavities of lesion with the balloon expandable Wall, the final internal nasal branches is put up is located at nasal sinus Dou Kou, two part difference position for the small shape in the big centre in two, center section In the interior exocoel of nasal sinus mouth, by the intranasal stent fixing card tightly at nasal sinus mouth;
G) the sacculus release is shunk, and the foley's tube, the guiding seal wire and the guiding catheter are withdrawn from, the nose Inner support is stayed in human body, and operation is completed.
In another preference, the intranasal stent is used for nasal sinus (including sinus frontalis, maxillary sinus, sphenoid sinus, the sieve for treating lesion Sinus) and nasal cavity, the sinus frontalis being particularly usually not easily accessible to for medicine.In another preference, the intranasal stent Length L1 be 10-160mm;Preferably, 15-150mm;More preferably, 20-100mm.
In another preference, diameter D1 >=10mm of the maximum of the intranasal stent, it is preferable that 15-30mm, more preferably Ground, 15-20mm.
In another preference, diameter D2 >=4mm at the minimum of the intranasal stent, it is preferable that 8-15mm, more preferably Ground, 8-10mm.
In another preference, the waist of the intranasal stent is equipped 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 the region of a diameter of D2 is connected with the region of a diameter of D1 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 stent can be arbitrary shape, it is therefore preferable to circular or ellipse, institute The diameter D2 stated at the diameter D1 and minimum of the maximum of intranasal stent is by the area equivalent of the cross section of the intranasal stent For the diameter corresponding to the circle of same area.
In another preference, when the region of a diameter of D2 is attached with the region of a diameter of D1 by straight line, meeting An 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 the region of a diameter of D2 is attached with the region of a diameter of D1 by curved surface in another preference Tangent 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 preferably Ground, 20 ° of 70 ° of < β <.
In another preference, under expansion state, intranasal stent is symmetrical on central axes or some section rule Shape.
In another preference, under expansion state, intranasal stent be adapt to lesion nasal sinus or nasal cavity it is substandard Shape.
In another preference, the intranasal stent enters from nasal cavity, and is pushed into the nasal sinus of lesion or nasal cavity.
In another preference, the intranasal stent is under from the expansion state of external force pressure, its waist cross-sectional area It is more than twice of Dou Kou sections.
In another preference, the intranasal stent is the shape that the big centre in two is small under expansion state, such as:Butterfly Junction type, hourglass shape, I-shaped etc..Such shape can allow the intranasal stent not moved to well positioned at nasal sinus Dou Kou Other positions, so accurately can be needed the diseased region of drug therapy to be administered.
In another preference, most of or even all degradation material of the intranasal stent, only sub-fraction Or without metal material.
In another preference, the accounting of the degradation material in the intranasal stent is 90%-100%.
In another preference, the material of the intranasal stent is magnesium alloy or magnesium alloy and polymer (such as polylactic acid guarantor Sheath, degradable fat etc.) mixture, the intranasal stent of magnesium alloy be degraded in human body free state magnesium, carbon dioxide and The material of the harmless good biocompatibility such as water, these products can be absorbed by the body or drain, nothing nontoxic to human body Accumulation.
In another preference, the material of the intranasal stent is ferrous alloy, or ferrous alloy and polymer are (such as poly- breast Sour protective layer, degradable fat etc.) mixture, the intranasal stent of ferrous alloy is degraded to free state iron, dioxy in human body Change the material of the harmless good biocompatibility such as carbon and water, these products can be absorbed by the body or drain, to human body It is nontoxic, without accumulation.
In another preference, the material of the intranasal stent is polylactic acid, and the intranasal stent of polylactic acid is in human body Carbon dioxide and water directly are degraded to, can be absorbed by the body or drain, it is nontoxic to human body, without accumulation.
In another preference, the intranasal stent 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 stent and lesion, carry on intranasal stent Medicine be slowly diffused into the tissue of nasal sinus and nasal cavity, treatment has the region of inflammation.
In another preference, intranasal stent carries medicine, and the medicine on intranasal stent will not be lost in out of human body quickly, Enough long-times can be stopped in human body memory, can be spread to the pathological tissues for needing anti-inflammatory, ensure medicine effectively to diseased region Treat in domain.
In another preference, medicine can be anti-inflammation drugs, such as antibiotic (such as gentamicin);It can also be hormone Class medicine (such as dexamethasone);It can also be mucus diluent (myrtol, eucalyptol, limonene and australene).
In another preference, the internal nasal branches is provided with load medicine body, and the load medicine body is used to store the medicine, described Medicine body is carried as following any structure or its combination:Aperture, groove 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 medicines Thing.
In another preference, the intranasal stent is hollow structure, and the side wall of the intranasal stent is engraved structure, non- Void region includes girder and connecting rod;The quantity of the girder is n, wherein, 3≤n≤50, the shape of the girder be with Lower any shape or its combination:Linear pattern, U-shaped, V-type, M types, W types, sine curve or irregular shape;The adjacent girder it Between connected by the connecting rod;The shape of void region is following any shape or its combination:Square, rectangle, circle, Diamond shape, shuttle-type, irregular shape.
In another preference, the wall thickness of the intranasal stent is 0.01-2mm, it is preferable that 0.05-0.2mm.
In another preference, the width of the girder is 0.01-2mm, it is preferable that 0.05-0.2mm.
In another preference, the connecting rod is attached to the optional position of the girder.
It is to 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 solution.As space is limited, exist This 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 existing Have technology describe needed in attached drawing do and simply introduce, it should be apparent that, drawings in the following description are only this Some embodiments of invention, for those of ordinary skill in the art, without creative efforts, can be with Other attached drawings are obtained according to these attached drawings.
Fig. 1 a are the foley's tubes in an example of the invention, and internal layer sacculus and outer layer sacculus are in unexpanded state Structure diagram.
Fig. 1 b are the foley's tubes in an example of the invention, and internal layer sacculus is in expansion state, and outer layer sacculus is in The structure diagram of unexpanded state.
Fig. 1 c are the foley's tubes in an example of the invention, and internal layer sacculus and outer layer sacculus are in expansion state Structure diagram.
Fig. 2 a are the foley's tubes in an example of the invention, and stent pressure is held in outside sacculus, and internal layer sacculus and outer layer ball Capsule is in the structure diagram of unexpanded state.
Fig. 2 b are the foley's tubes in an example of the invention, and stent pressure is held in outside sacculus, and internal layer sacculus is in expansion State, outer layer sacculus are in the structure diagram of unexpanded state.
Fig. 2 c are the foley's tubes in an example of the invention, and stent pressure is held in outside sacculus, and internal layer sacculus and outer layer ball Capsule is in the structure diagram of expansion state.
Fig. 3 a are the structure diagrams of the foley's tube pressurization mouth in an example of the invention.
Fig. 3 b are the structure diagrams of the foley's tube pressurization mouth in another example of the invention.
Fig. 4 be after the foley's tube pressurization in an example of the invention outer layer sacculus along extraneous profile to without hindrance block material The structure diagram of zone broadening.
Fig. 5 is the structure diagram of the guiding catheter in an example of the invention.
Fig. 6 is the structure diagram of the girder of the intranasal stent in an example of the invention.
Fig. 7 a are the structure diagrams of the intranasal stent of the pass load medicine in an example of the invention.
Fig. 7 b are the structure diagrams of the intranasal stent of the groove profile load medicine in an example of the invention.
Fig. 7 c are the profiles of the intranasal stent of the coating type load medicine in an example of the invention.
Fig. 8 is schematic diagram of the guiding catheter in an example of the invention into nasal sinus.
Fig. 9 is schematic diagram of the guiding seal wire through Dou Kou into nasal sinus inner cavity in an example of the invention.
Figure 10 is that the pressure in an example of the invention holds the schematic diagram that standoff sacculus reaches the Dou Kou of lesion.
Figure 11 is that the internal layer sacculus in an example of the invention is pressurized expansion while intranasal stent is also by balloon expandable Schematic diagram.
Figure 12 is that the outer layer sacculus in an example of the invention is pressurized expansion while intranasal stent is also by balloon expandable Schematic diagram.
Figure 13 is the sacculus release in an example of the invention, and foley's tube, guiding seal wire, guiding catheter are withdrawn from, intranasal The schematic diagram that stent stays in the body.
Figure 14 is the structure diagram of the foley's tube for being equipped with three sacculus in an example of the invention.
Figure 15 is the structure diagram of the foley's tube for being equipped with a sacculus in an example of the invention.
In each attached drawing, each sign is as follows:
1- foley's tubes;
2- sacculus;
3- guiding catheters;
4- stents;
5- girders;
6- carries medicine hole;
7- medicine-carrying troughs;
8- guides seal wire;
9- internal layers sacculus pressurization mouth;
10- outer layers sacculus pressurization mouth;
11- internal layer sacculus;
12- outer layer sacculus;
13- distal balloon catheters;
Sacculus among 14-;
15- proximal balloons;
16- both ends sacculus pressurization mouth;
Sacculus pressurization mouth among 17-;
18- guidewire ports.
Embodiment
The present inventor, by largely screening, develops a kind of nasal sinus foley's tube first by in-depth study extensively With the sub-assembly of the intranasal stent of balloon-expandable, compared with prior art, the quantity of foley's tube implanting saccule at front end of the present invention is 1-3 A, the property of sacculus is according to the different and different of sacculus quantity, but purpose is for the nasal sinus or nasal cavity of expansion support lesion; The intranasal stent of balloon-expandable is overlaid on outside sacculus in an initial condition, with nasal sinus or nasal cavity is used to support after balloon expandable, is prevented Only nasal sinus or nasal membrane are adhered, in addition, being the small shape in the big centre in two in expansion state lower carriage, can be allowed intranasal Stent does not move to other positions positioned at nasal sinus Dou Kou well, so can be accurately to the lesion for needing drug therapy Position administration, stent is degradable, and medicine is attached with stent, and medicine can treat inflammation, complete this hair on this basis It is bright.
Term
As used herein, term " compliance " refers to the changing value of the balloon volume in one unit pressure of every change, leads to In the case of often:It is non-compliance sacculus when compliance is no more than 1.1;It is semi-compliant sacculus when compliance is 1.3-1.8;Comply with Property be more than 2 when be compliant balloon.
As used herein, term " high pressure sacculus " refers to that the rated pressure scope of sacculus is the sacculus of 2-20ATM.
As used herein, term " low pressure sacculus " refers to that the rated pressure of sacculus is not more than the sacculus of 2ATM.
As used herein, term " intranasal stent " and " stent " etc. are used interchangeably.
The present invention provides a kind of nasal sinus foley's tube and the sub-assembly of the intranasal stent of balloon-expandable, it is that one kind has The sub-assembly of specific structure.
The intranasal stent of balloon-expandable of the present invention can be the materials such as magnesium alloy, ferrous alloy, polylactic acid.Stent wall thickness 0.01-2mm;Preferably, 0.05-0.2mm, stent are engraved structures, and non-void region is the girder of a rule, the width of girder It is 0.01-2mm;Preferably, 0.05-0.2mm, the shape of girder can be linear pattern, U-shaped, V-type, M types, W types, sine curve Or any one or more of the various line styles such as irregular shape.Adjacent girder is linked together by connecting rod, connecting rod connects The optional position of girder is connected to when connecing adjacent girder.The shape of void region can be square, rectangle, circle, water chestnut Any one or more variously-shaped such as shape, shuttle-type, irregular shape.
Under expansion state, stent can be the small shape in the big centre in two, such as hourglass, I-shaped, dog bone shape. Such shape can allow stent not move to other positions positioned at nasal sinus Dou Kou well, so can be accurately to needs The diseased region administration of drug therapy.
Stent and nasal sinus or nasal cavity tissue abutting contact, the medicine carried on stent are slowly diffused into the group of nasal sinus and nasal cavity In knitting, treatment has the region of inflammation.
When stent is magnesium alloy, ferrous alloy, polylactic acid in itself, these materials can degrade in human body.
Magnesium alloy bracket is magnesium alloy in itself, or magnesium alloy and polymer (such as polylactic acid protective layer, degradable fat) Mixture, the material of the harmless good biocompatibility such as free state magnesium, carbon dioxide and water is degraded in human body, These products can be absorbed by the body or drain.Ferrous alloy stent is ferrous alloy in itself, or ferrous alloy and polymer The mixture of (such as polylactic acid protective layer, degradable fat), is degraded to free state iron, carbon dioxide and water etc. to people in human body The material of the harmless good biocompatibility of body, these products can be absorbed by the body or drain.Polylactic acid bracket is simply poly- in itself Lactic acid, polylactic acid are directly degraded to carbon dioxide and water in human body, can be absorbed by the body or drain, nontoxic to human body, without product It is tired.After the stenter to implant human body of these materials, it is final degrade adult body can metabolism material.
Medicine so on stent will not be both lost in out of human body quickly;And the time that medicine retains in human body is enough It is long, the pathological tissues for needing anti-inflammatory are can be spread to, ensure that medicine effectively treats lesion region.
Pressure is held on foley's tube stent in advance, and stent carries medicine.
Medicine can be anti-inflammation drugs, such as antibiotic (such as gentamicin);Can also be that hormone medicine (such as fills in rice Pine etc.);It can also be mucus diluent (myrtol, eucalyptol, limonene and australene).
Medicine adhering mode:In the load medicine hole that can have been carved on stent;The load medicine that can also have been carved on stent In groove;It can also be and be uniformly blended in the coating of rack surface, which can have one or more layers, can be loaded with a variety of Medicine.
The present invention also has guiding catheter and guiding seal wire.
By guiding catheter, guiding seal wire, pressure is held into standoff nasal sinus foley's tube and is transported to lesion nasal sinus or nasal cavity Region.
The technology implementation process of the intranasal stent of balloon-expandable of the present invention is:
A) suitable guiding catheter is selected, reaches the nasal sinus or nasal region of lesion.
B) by guiding catheter, guiding seal wire, pressure is held into standoff nasal sinus foley's tube and is transported to lesion nasal sinus or nose Cavity region.
C) pressurising expansion carries out sacculus by the pressurization passageway of nasal sinus foley's tube, the nasal sinus of lesion by balloon expandable, Stent after expansion is close to nasal sinus or nasal cavity inner wall.
D) sacculus release, sacculus are retracted, and foley's tube is withdrawn from;Guiding seal wire, guiding catheter are withdrawn from again, performed the operation Into.In this way, foley's tube, guiding seal wire, guiding catheter withdraw from human body successively, stent is stayed in human body.
In another preference, the sacculus is double-layered balloon, in operation, first passes through the interior of nasal sinus foley's tube The pressurization passageway of layer sacculus is to internal layer sacculus pressurising, internal layer balloon expandable, and the nasal sinus of lesion is by internal layer balloon expandable, while outer layer For stent on sacculus and sacculus together by internal layer balloon expandable, the stent after expansion is close to nasal sinus or nasal cavity inner wall, then expands Outer layer sacculus, outer layer sacculus continue expandable stent under a low-pressure, and outer layer sacculus is to spacious zone broadening, outer layer sacculus Stent is also expanded while expansion, direction expansion of the stent to nasal sinus cavity wall has the trend for being close to nasal sinus cavity wall.Finally Stent becomes the small shape in the big centre in two, and the stent of the small shape in the big centre in two is located at nasal sinus Dou Kou, the major part at stent both ends It is located at the interior exocoel of nasal sinus mouth respectively, stent waist is fixed and is clamped at nasal sinus mouth.
Main advantages of the present invention include:
(a) sacculus of foley's tube front end can effectively strut the nasal sinus or nasal cavity of lesion, and have certain deformation Ability, can be bonded lesion region well, prevent nasal sinus or nasal membrane to be adhered.
(b) intranasal stent is the small shape in the big centre in two under expansion state so that intranasal stent can be very good position Other positions are not moved in nasal sinus Dou Kou, so accurately the diseased region of drug therapy can be needed to be administered.
(c) intranasal stent 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.
(d) medicine is attached with intranasal stent, which can be used for treating inflammation, prevent nasal cavity or nasal sinus mouth to be adhered, and Medicine will not be lost in out of human body quickly, can be stopped enough long-times in human body memory, be can be spread to the lesion group for needing anti-inflammatory Knit, ensure that medicine effectively treats lesion region.
(e) intranasal stent is held by pressure on the sacculus for being wrapped in foley's tube in vitro, is compressed to a size of very little, profit Walked in intranasal stent in tiny nasal cavity or nasal sinus.
Therefore, sub-assembly of the invention can effectively treat nose-nasosinusitis, after surgery plant the intranasal stent of balloon-expandable Enter lesion nasal sinus or nasal cavity, nasal sinus or nasal cavity are supported, for preventing nasal sinus or nasal membrane to be adhered.
Especially, when the sacculus of foley's tube is double-layered balloon, internal layer sacculus high pressure, size are stablized relatively, are used for Expand the nasal sinus Dou Kou of lesion so that Dou Kou is reopened and drained;Outer layer sacculus is resistance to be forced down, possesses big deformability, can To cause stent-expansion bigger and along the shape expansion in the region such as nasal cavity and Dou Kou for the follow-up expandable stent that continues, it is close to this The inner wall in a little regions.Internal layer sacculus is high pressure resistant and size is stablized relatively, it causes the shape of surrounding material to tend to and sacculus Shape itself is consistent;Outer layer sacculus is low pressure sacculus.Intranasal stent is strutted by sacculus, is initially strutted by internal layer balloon expandable, At nasal sinus mouth, the shape of stent is suitable with the shape after internal layer balloon expandable for expansion;And then by outer layer balloon expandable and after Continuous to strut, outer layer sacculus has very big deformability, moulding ability to the zone broadening of no obstacle, to adapt to sinus cavities energy by force Power is strong, adapts to the nasal sinus and nasal cavity structure of complexity.
With reference to specific embodiment, the present invention is further explained.It is to be understood that these embodiments are merely to illustrate the present invention Rather than limit the scope of the invention.In addition, attached drawing is schematic diagram, thus apparatus of the present invention and equipment and show from described Size 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 relation Term is used merely to distinguish one entity or operation from another entity or operation, without necessarily requiring or implying There are any actual relationship or order between these entities or operation.Moreover, term " comprising ", "comprising" or its Any other variant is intended to non-exclusive inclusion so that process, method, article including a series of elements or Equipment not only includes those key elements, but also including other elements that are not explicitly listed, or further 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 " limited Element, it is not excluded that also there are other identical element in the process, method, article or apparatus that includes the element.
Embodiment
The sub-assembly of the intranasal stent of nasal sinus foley's tube and balloon-expandable of the present embodiment includes foley's tube 1 and sacculus The intranasal stent 4 of expanding.As shown in Fig. 1 a-1b, the front end of the foley's tube 1 of the present embodiment is equipped with double-layered balloon, including outer layer Sacculus 12 and internal layer sacculus 11, corresponding, foley's tube 1 is additionally provided with outer layer sacculus pressurization mouth 10 and internal layer sacculus pressurization mouth 9, outside Layer sacculus pressurization mouth 10 is used for the expansion outer layer sacculus 12 that pressurizes, and internal layer sacculus pressurization mouth 9 is used for the expansion internal layer sacculus 11 that pressurizes, its In, internal layer sacculus pressurization mouth 9 and outer layer sacculus pressurization mouth 10 are located at the same side of the foley's tube 1, in addition, internal layer sacculus 11 It is high pressure sacculus, outer layer sacculus 12 is low pressure sacculus.Intranasal stent 4 is expanded or shunk under external force, itself is without expansion The ability opened or shunk.Intranasal stent 4 presses the outside for being held in outer layer sacculus 12, is expanded with sacculus, as shown in figs. 2 a-2 c.
In another preference, as shown in Figure 3a, internal layer sacculus pressurization mouth 9 and outer layer sacculus pressurization mouth 10 are symmetrically distributed in The both sides of foley's tube 1, and the tail end angulation of pressurization mouth and foley's tube 1 is 60 °.
In another preference, as shown in Figure 3b, internal layer sacculus pressurization mouth 9 and outer layer sacculus pressurization mouth 10 are symmetrically distributed in The both sides of foley's tube 1, and the axis perpendicular of pressurize mouth and foley's tube 1.
The pressure voltage P1 of internal layer sacculus 11 is about 15ATM, and internal layer sacculus 11 is non-compliance, and deformation quantity is limited, size Stablize relatively.The material of internal layer sacculus 11 is Pebax.As shown in figure 4, outer layer sacculus 12 is under expansion state, its deformation quantity is big, Moulding ability is strong, adaptable to the zone broadening of no obstacle, adapts to the nasal sinus and nasal cavity structure of complexity.Outer layer sacculus 12 volume increases with the increase of pressure, and usual volume can change very big, balloon volume change at lower pressures Change up to 300%.The pressure voltage P2 of outer layer sacculus 12 is 0.5ATM, and outer layer sacculus 12 is compliance, its material is silica gel.
The sub-assembly of the present embodiment further includes guiding catheter 3 and guiding seal wire 8.Wherein, Fig. 5 shows drawing for the present embodiment The structure diagram of conduit 3.
In operation, as shown in figures 8-13, intranasal stent 4 pressure is held in the sacculus in unexpanded state, guiding Seal wire 8 is penetrated in foley's tube 1 from guidewire port 18, and foley's tube 1 is placed in guiding catheter 3.Guiding catheter 3 is sent to lesion Sinus areas, it is to go deep into lesion sinus areas to promote guiding seal wire 8, promotes foley's tube 1 along guiding seal wire 8, and pressure is possessed The sacculus of intranasal stent 4 is pushed into lesion sinus areas, first pressurizes and expands to internal layer sacculus 11, and then outer layer sacculus 12 and stent 4 As internal layer sacculus 11 is expanded and is attached to 11 outer wall of internal layer sacculus;Then pressurize and expand to outer layer sacculus 12, stent 4 is with outer layer Sacculus 12 is expanded and is attached to 12 outer wall of outer layer sacculus, and final intranasal stent 4 becomes the small shape in the big centre in two, center section position In nasal sinus Dou Kou, two part is located at the interior exocoel of nasal sinus mouth, intranasal stent 4 is fixed and is clamped at nasal sinus mouth, finally respectively Sacculus release is shunk, and foley's tube 1, guiding seal wire 8 and guiding catheter 3 are withdrawn from, and intranasal stent 4 is stayed in human body, and operation is completed.
The intranasal stent 4 of the present embodiment is hollow structure, and the side wall of intranasal stent 4 is engraved structure, non-void region bag Girder 5 and connecting rod are included, wherein, the structure of girder 5 is as shown in Figure 6.The quantity n of girder 5 is 30, and the shape of girder 5 is V Type;Connected between adjacent girder 5 by connecting rod, connecting rod is attached to the optional position of girder 5;The shape of void region is Diamond shape.The wall thickness of intranasal stent 4 is 0.1mm.The width of girder 5 is 0.1mm.
For intranasal stent 4 under expansion state, its length L1 is 40mm, and shape is the adaptation nasal sinus of lesion or not advising for nasal cavity Trellis shape.Overall shape is small for the big centre in two, as butterfly structure.Such shape can allow intranasal stent 4 to be located at well Nasal sinus Dou Kou and do not move to other positions, so can be accurately to being needed the diseased region of drug therapy to be administered.Wherein, nose The diameter D1 of the maximum of inner support 4 is 18mm, and the diameter D2 at minimum is 10mm.The region of a diameter of D2 is with a diameter of D1's Region is by circular sliding slopes.When the region of a diameter of D2 and the region of a diameter of D1 are attached by curved surface, curve Each point at tangent line and horizontal line angle be β, 20 ° of 70 ° of < β <.
Intranasal stent 4 is biocompatible material, and is degradable.The material of the intranasal stent 4 of the present embodiment closes for magnesium Gold or the mixture of magnesium alloy and polymer (such as polylactic acid protective layer, degradable fat), the intranasal stent of magnesium alloy is in human body The material of the harmless good biocompatibility such as free state magnesium, carbon dioxide and water is degraded to, these products can be by people Body absorbs or excretion, nontoxic to human body, without accumulation.
In another preference, the material of intranasal stent 4 is ferrous alloy, or ferrous alloy and polymer (such as polylactic acid Protective layer, degradable fat etc.) mixture, the intranasal stent of ferrous alloy be degraded in human body free state iron, carbon dioxide and The material of the harmless good biocompatibility such as water.
In another preference, the material of intranasal stent 4 is polylactic acid, and the intranasal stent of polylactic acid is directly degraded in human body For carbon dioxide and water, it can be absorbed by the body or drain, it is nontoxic to human body, without accumulation.
In addition, the surface of intranasal stent 4, which is equipped with, carries medicine hole 6 (as shown in Figure 7a), storage medicine can be loaded by carrying in medicine hole 6 Thing, medicine are used to treat inflammation, prevent nasal cavity or nasal sinus mouth to be adhered.Medicine can be anti-inflammation drugs, as antibiotic is (as big mould in celebrated Element etc.);Can also be hormone medicine (such as dexamethasone);It can also be mucus diluent (myrtol, eucalyptol, lemon Lemon alkene and australene).
In another preference, the surface of intranasal stent 4 is equipped with the medicine-carrying trough 7 for being used for loading storage medicine (such as Fig. 7 b institutes Show).
In another preference, the surface of intranasal stent 4 scribbles medication coat (as shown in Figure 7 c), wherein, closed in stent The outside of layer gold first scribbles one layer of affine layer, i.e. stent intermediate layer, and drug-loaded layer, the number of drug-loaded layer are coated with the outside of affine layer Amount has no particular limits, and can be as needed one or more layers, for loading a variety of different pharmaceuticals.It is two in the present embodiment Layer, loads two kinds of medicines.
In another preference, the surface of intranasal stent 4 is any combination shape for carrying medicine hole 6, medicine-carrying trough 7 and coating Formula, medicine is stored for loading.
Under expansion state, the nasal sinus or nasal cavity tissue abutting contact of intranasal stent 4 and lesion, carry on intranasal stent 4 Medicine be slowly diffused into the tissue of nasal sinus and nasal cavity, treatment has the region of inflammation.Medicine on intranasal stent 4 will not be quickly It is lost in out of human body, enough long-times can be stopped in human body memory, the pathological tissues for needing anti-inflammatory are can be spread to, ensure that medicine has Effect ground is treated by lesion region.
The intranasal stent 4 can be used for the nasal sinus (including sinus frontalis, maxillary sinus, sphenoid sinus, sieve sinus) and nasal cavity for the treatment of lesion, especially It is the sinus frontalis being usually not easily accessible to for medicine.
Embodiment 2
The sub-assembly and embodiment 1 of the intranasal stent of nasal sinus foley's tube and balloon-expandable of the present embodiment are similar, with Unlike the present embodiment foley's tube sacculus quantity be 3, be distal balloon catheter 13 respectively as shown in figure 14, in Between sacculus 14 and proximal balloon 15, and three sacculus are cascaded structures.Middle sacculus 14 is non-compliance, for expanding lesion Dou Kou;Distal balloon catheter 13 and proximal balloon 15 are compliant balloons, for expanding the interior exocoel of Dou Kou, so as to expand internal nasal branches The both ends of frame so that intranasal stent can be positioned to be departed from without mobile from Dou Kou.
The foley's tube of the present embodiment is equipped with two pressurization mouths, is that both ends sacculus pressurization mouth 16 and middle sacculus pressurize respectively Mouth 17, both ends sacculus pressurization mouth 16 are used to pressurize to distal balloon catheter 13 and proximal balloon 15, and middle sacculus pressurization mouth 17 is used to give Middle sacculus 14 pressurizes.
Embodiment 3
The sub-assembly and embodiment 1 of the intranasal stent of nasal sinus foley's tube and balloon-expandable of the present embodiment are similar, with Unlike the present embodiment foley's tube sacculus quantity be 1, as shown in figure 15, sacculus 2 is non-compliance;Ball The center section diameter dimension of capsule 2 is smaller, for expanding the Dou Kou of lesion;Both ends size is larger, for expanding inside and outside Dou Kou Chamber, so as to expand the both ends of intranasal stent so that intranasal stent can be positioned without moving.Sacculus 2 is non-compliance, and It is high pressure sacculus.
All references mentioned in the present invention is incorporated herein by reference, independent just as each document It is incorporated as with reference to such.In addition, it should also be understood that, after reading the above teachings of the present invention, those skilled in the art can To be made various changes or modifications to the present invention, such equivalent forms equally fall within the model that the application the appended claims are limited Enclose.

Claims (10)

1. the sub-assembly of a kind of nasal sinus foley's tube and the intranasal stent of balloon-expandable, it is characterised in that the sub-assembly includes
The intranasal stent of balloon-expandable, the intranasal stent are expanded or shunk under external force, itself is without expansion or receives The ability of contracting;The intranasal stent is conformal with lesion nasal sinus or nasal cavity, and the intranasal stent is divided under expansion state Near-end, waist and distal end, wherein, the cross-sectional area of near-end is S1, and the cross-sectional area of waist is S2, and the cross-sectional area of distal end is S3, and S2 < S1 and S2 < S3;And
Nasal sinus foley's tube, the front end of the foley's tube are equipped with n sacculus, wherein, 1≤n≤3.
2. sub-assembly as claimed in claim 1, it is characterised in that the foley's tube is equipped with pressurization mouth, and the pressurization mouth is used The sacculus is expanded in pressurization.
3. sub-assembly as claimed in claim 1, it is characterised in that the intranasal stent is biocompatible material, and is to drop Solution;The intranasal stent is following any material or its combination:Magnesium alloy, ferrous alloy and polylactic acid.
4. sub-assembly as claimed in claim 1, it is characterised in that the quantity of the sacculus is 2, and the sacculus is double-layer ball Capsule, the double-layered balloon are divided into internal layer sacculus and outer layer sacculus;The internal layer sacculus is high pressure sacculus, and the outer layer sacculus is low Pressure ball capsule.
5. sub-assembly as claimed in claim 4, it is characterised in that the pressure voltage of the internal layer sacculus is P1, wherein, 2ATM≤ P1≤30ATM;The internal layer sacculus is non-compliance or semi-compliant sacculus.
6. sub-assembly as claimed in claim 4, it is characterised in that the pressure-resistant of the outer layer sacculus is P2, wherein, P2≤ 2ATM;The outer layer sacculus is compliant balloon.
7. sub-assembly as claimed in claim 1, it is characterised in that the quantity of the sacculus is 3, is distal balloon catheter respectively, Middle sacculus and proximal balloon, three sacculus are cascaded structures.
8. sub-assembly as claimed in claim 7, it is characterised in that the middle sacculus is non-compliance or semi-compliant, Dou Kou and pressure for expanding lesion are held in the intranasal stent outside the middle sacculus;The distal balloon catheter and described near It is compliant balloon to hold sacculus, and the interior exocoel and pressure for expanding Dou Kou are held in outside the distal balloon catheter and the proximal balloon The intranasal stent in portion.
9. sub-assembly as claimed in claim 1, it is characterised in that the sub-assembly includes guiding catheter and guiding seal wire.
A kind of 10. application method of the intranasal stent of balloon-expandable, it is characterised in that the described method includes:
A) sub-assembly as claimed in claim 1 is provided;
B) sacculus of the foley's tube possesses the intranasal stent for the appearance face pressure of unexpanded state and the sacculus, described Guiding seal wire is placed in the foley's tube, and the foley's tube is placed in the guiding catheter;
C) guiding catheter is sent to lesion sinus areas;
D) the guiding seal wire is promoted to go deep into lesion sinus areas;
E) foley's tube is promoted along the seal wire, and the sacculus for possessing the intranasal stent will be pressed to be pushed into lesion nasal sinus Region;
F) pressurize and expand to the sacculus, the intranasal stent is close to the nasal sinus cavity wall of lesion with the balloon expandable, most The internal nasal branches is put up eventually is located at nasal sinus Dou Kou for the small shape in the big centre in two, center section, and two part is located at nose respectively The interior exocoel of Dou Kou, by the intranasal stent fixing card tightly at nasal sinus mouth;
G) the sacculus release is shunk, and the foley's tube, the guiding seal wire and the guiding catheter are withdrawn from, the internal nasal branches Frame is stayed in human body, and operation is completed.
CN201710909491.5A 2017-09-29 2017-09-29 Combination of sinus balloon catheter and balloon-expandable intra-nasal stent Active CN107898540B (en)

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