CN107485472A - Biodegradable stent in the treatment paranasal sinusitis is built into nasal sinus road by a device - Google Patents

Biodegradable stent in the treatment paranasal sinusitis is built into nasal sinus road by a device Download PDF

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Publication number
CN107485472A
CN107485472A CN201710668471.3A CN201710668471A CN107485472A CN 107485472 A CN107485472 A CN 107485472A CN 201710668471 A CN201710668471 A CN 201710668471A CN 107485472 A CN107485472 A CN 107485472A
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CN
China
Prior art keywords
sinus
support
nasal
characterised
air bag
Prior art date
Application number
CN201710668471.3A
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Chinese (zh)
Inventor
王清红
Original Assignee
王清红
王永立
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Priority to CN201710668471.3A priority Critical patent/CN107485472A/en
Publication of CN107485472A publication Critical patent/CN107485472A/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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • 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
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention uses local surfaces anesthesia method, pass through a device, the Biodegradable scaffold that lateral surface is carried to slow releasing pharmaceutical is inserted in the sinus passages of the bilateral mandibular sinus of lesion, bilateral sinus frontalis, bilateral sphenoid sinus, solves the sinus passages drainage problem of paranasal sinus, treats acute and chronic nasal sinusitis.Support inserts initial stage, struts sinus passages surrounding tissue, progressively rebuilds and repairs with the function of sinus, and support in half a year, to 3 years, gradually had no to remain by degraded.Straight tube or bend pipe on the front end sleeve of hard nasal endoscopes, carry Fig. 1 devices and enter in sinus passages, first extract the fester in sinus cavities out, and sinus cavities are rinsed;Now the side wall of sinus passages is because of infiltration decoction congestion and edema regression;The outer overlay film of support is removed, support leading portion and stage casing is opened by air bag, adjusts segment length in support, finally holder back section is opened, completes inserting for drainage stent.

Description

Biodegradable stent in the treatment paranasal sinusitis is built into nasal sinus road by a device

Technical field

The present invention relates to biodegradable drainage stent is inserted into nasal sinus by a device with the method for No operation to lead to In road, the drainage of unobstructed nasal cavity, paranasal sinus, acute and chronic paranasal sinusitis is treated:Bilateral mandibular sinus, bilateral sinus frontalis and bilateral sphenoid sinus.

Background technology

It is now recognized that the pathogenic factor of paranasal sinusitis causes Dou Kou obstructions to cause in nasal sinus mainly due to a variety of causes Infection, so the method for treating acute and chronic nasal sinusitis instantly mainly has:1. the nasal cavity locally and systemically nasal sinus sacculus of drug therapy 2. Dilatation opens the nasal endoscopic surgery removal lesion tissue of sinus passages adequate drainage 3., re-establish nasal cavity, nasal sinus it is good Ventilation drainage.Above treatment method is all less than optimal, and reason is as follows:A drug therapies are difficult to make sinus passages drainage unobstructed, Administration time length is caused, part is infected unmanageable;B nasal sinus balloon dilatation wounds are small, can not still be fully solved sinus passages Drainage problem;Pathological tissues quickly can thoroughly be dispelled adequate drainage by c nasal endoscopic surgeries, but operation is related to face, it is necessary to right Patient airway, which is intubated, implements general anesthesia processing, brings painful and psychological shade to patient, postoperative nasal cavity is clogged and had certain Recurrence rate is restricted nasal endoscopic surgery.It is ripe with the research of degradable macromolecule biomaterial, carry drug stent Appearance, the method can need not perform the operation, using local surfaces anesthesia method, draw with regard to the sinus passages that can reach open paranasal sinus Flow problem, support insert initial stage, strut sinus passages surrounding tissue, progressively rebuild and repair with the function of sinus, support exists Half a year, gradually degraded had no to remain to 3 years.It is not required to be in hospital, can not be influenceed incidence CT from institute and nuclear-magnetism is total to after treat-and-release Shake inspection.

The content of the invention

The purpose of the present invention in order to:Only with the mode of surface anesthesia, carrying device is guided by hard nasal endoscopes, by outside The biodegradable drainage stent that face carries medicine is put into the sinus passages of paranasal sinus and strutted middle nasal meatus or recessus sphenoethmoidalis, reaches To the purpose of nasal sinus adequate drainage.

The purpose of the present invention can be achieved through the following technical solutions:

Step A:Fester rinses in sinus cavities

Specific method:First nasal cavity inner surface is anaesthetized with surface anaesthetic, it is hollow straight on the front end card of hard nasal endoscopes Pipe or bend pipe, Fig. 1 devices are carried, 0 degree or 30 degree of selection is determined by the custom of operator and which specific paranasal sinus for the treatment of The nasal endoscopes at angle, device insertion straight tube or bend pipe, as nasal endoscopes enter nasal cavity, find sinus frontalis in middle nasal meatus and maxillary sinus are opened Mouthful, Opening of sphenoid sinus is found at butterfly pharyngeal recess, Fig. 1 is inserted into sinus passages, is advanced slowly, is stopped after having resistance, by Fig. 1 devices The tail end of hollow tube inner core slightly give forward, connect syringe, extracted out with the fester in syringe holder sinus cavities, connect another note Emitter, into sinus cavities saline injection rinse, be repeated several times, to extract out intracavity liquid it is limpid, after the completion of inner core slightly to Outer pumpback.The silk floss material of front end and the outer silk floss coating of overlay film carry anesthesia and corticosteroid medication, anesthesia in Fig. 1 devices Sinus passages surrounding mucosa and make mucous hyperemia edema extinction.

Step B:Passage is built into Biodegradable stents

The cap for the protection blade being stuck on bar is removed, the blade on exposure bar, by rope by the outside pumpback of overlay film, covered Splitted in film pumpback by blade, until removing overlay film, remove blade of the hoop on bar, inflated frontal air bag with syringe, prop up Frame front end is opened in petal specimen page, and device is slightly outwards withdrawn, is affixed front end petal and nasal sinus inwall, with syringe by stage casing gas Capsule is inflated, and under the observation of nasal endoscopes, is outwards affected 2 guide rods to the right, guide rod is outwards moved right, adjustment support stage casing Length, stage casing outer rim stop after reaching collar extension, finally by rear end airbag aeration, after support is sufficiently spread out, evacuate in 3 air bags Fig. 1 devices are taken out after gas.

Sphenoid sinus is because passage is very short, and most of Opening of sphenoid sinus is visible under nasal endoscopes direct-view, and small part is covered by upper concha nasalis media Lid, support stage casing is shorter, can regular length, be not required to adjust length, be mounted directly sphenoid sinus holder device.

Wait the paranasal sinus High resolution CT image by normal adult person under inspection by force according to dept. of radiology of Beijing Friendship Hospital Li Xiao, Promoting the circulation of qi body Multi-slice spiral CT on the original image, measure maxillary sinus, sinus frontalis, sphenoid sinus gasification chamber average volume are respectively 17.43ml, 3.42ml, 5.98ml, sinus cavities interior diameter remove the irregular of sinus cavities, diameter is in 1.3mm- in 1.8mm-3.2mm 2.5mm or so, (1) anterior length and the size of support leading portion can probably be estimated in Fig. 1 devices with this.To be warned in practical operation Cautious nose and nasal sinus anatomical variation, it can be judged by paranasal sinus CT examination.

Biodegradable timbering material is mostly PLA, polyglycolic acid, chitosan, polycaprolactone and some copolymers at present Such as PLA/polyglycolic acid copolymers, it is special that suitable calorifics, machinery can be obtained by the blending or copolymerization of the two or three Property and degradation speed support, these high polymer material good biocompatibilities, fully biodegradable, be metabolized as carbon dioxide and Water.Also magnesium alloy Biodegradable stents may be selected.

The anti-inflammatory drugs steroidal anti-inflammatory drugses such as dexamethasone carried on support and antiproliferative medicine such as taxol, thunder Pa mycin, slowly discharged for control medicine, it is more at present using carrier of the synthesis high polymer material as medicament slow release.

Brief description of the drawings

Fig. 1 is the structural representation of implementation of the present invention;

Fig. 2 is the partial enlarged drawing of Fig. 1 front ends;

Fig. 3 is the partial enlarged drawing in Fig. 1 stage casings;

Fig. 4 is amplification view of Fig. 1 devices along line A-A;

Fig. 5 is two structural representation of implementation of the present invention;

Fig. 6 is Fig. 5 side view;

Fig. 7 is the expanded view of Fig. 1 carrying Holders;

Embodiment

The present invention is described in detail with reference to the accompanying drawings and detailed description.

First nasal cavity inner surface is anaesthetized with surface anaesthetic, both ends open is non-on the front end card of hard nasal endoscopes (34) Elastomeric material hollow straight tube (31) or one end are in the bend pipe (30) of 30-45 degree bending, Fig. 1 devices are carried, by the custom of operator The nasal endoscopes at 0 degree or 30 degree angle of selection, Fig. 1 devices insertion straight tube or bend pipe are determined with which specific paranasal sinus for the treatment of, with Nasal endoscopes and enter nasal cavity, find sinus frontalis and maxillary sinus opening in middle nasal meatus, find Opening of sphenoid sinus at butterfly pharyngeal recess, Fig. 1 is inserted Enter sinus passages, be advanced slowly, stop after having resistance, the tail end of the hollow tube (1) in Fig. 1 devices is slightly sent forward, (25) connect Syringe is connect, is extracted out with the fester in syringe holder sinus cavities, (24) connect another syringe, and physiology salt is injected into sinus cavities The flushing liquors such as water are rinsed, and are repeated several times, to extract out intracavity liquid it is limpid, after the completion of hollow tube inner core (1) slightly outwards time Take out.

(2) of front end are made up of the silk floss material of somewhat resilient and are bonded into one with pipeline (4) in Fig. 1 devices, and shape is such as Hemispherical is bullet-headed, has more than 2 annular shell fragments (3) to be connected with (2) (4) inside it, avoids (2) when passing in and out sinus cavities Shift or come off into sinus cavities with (4), anesthetic can be carried in (2) and makes the medicine such as Chinese ephedra of nasal mucosa vesselses smooth muscle contraction Alkali, the outer silk floss coating (10) of overlay film (9) carry the medicine and corticosteroid medication for making nasal mucosa vesselses smooth muscle contraction, make to glue Film congestion and edema disappears.

The cap (18) for the protection blade (17) being stuck in Fig. 1 gear levers is removed, the blade on exposure bar, passes through rope (16) by overlay film (9) outside pumpback, splitted in overlay film pumpback by blade, until whole overlay film is removed, exposure support (8), simultaneously Appear two guide rods (12), (14), remove blade of the hoop on bar, inflated frontal air bag (5) with syringe by (26), Support front end is opened in petal specimen page in the presence of air bag, and Fig. 1 devices are slightly outwards withdrawn, make front-end bracket and nasal sinus inwall phase Patch, stage casing air bag (6) is inflated with syringe by (27), under the observation of nasal endoscopes, hold (12), (14) two guide rods Handle (19), (20) outwards affect to the right 2 guide rods, guide rod is outwards moved right, to adjust the length in support stage casing, stage casing Outer rim stops after reaching collar extension, inflates rear end air bag (7) finally by (28), back-end support expansion, holder back section is divided to two Individual petal is opened with upper type, is opened, passed through (26) with reaching concha nasalis media and concha nasalis inferior separation or sphenoid sinus outlet butterfly pharyngeal recess (27) (28) evacuate the gas in (5), (6), (7) 3 air bags, and 2 guide rods are slightly sent forward, remove the noose of front end, extract branch out Frame conveying device, complete inserting for support.

Hollow tube (4) in Fig. 2, is separated by cross-section, is formed 3 pipes that internal independence is not communicated with, is made (5) and (26) phase It is logical, (6) communicated with (27), (7) communicated with (28), and (22 (23) must have enough the air bag (21) in (26), (27), (28) Toughness and elasticity, it can probably estimate the pressure in (5) (6) (7) air bag.

Fig. 7 support is made up of synthesising biological degraded macromolecular material, the slow-absorbing in sinus passages, absorbs the time limit half Years -3 years, do not contained except leading portion is connected with the row's S types of back segment the 3rd in such as (41) (42) by biodegradated polymer materal in support As the slow releasing pharmaceutical of carrier, avoid being broken when S types are connected and deformed, have in remaining S types connection and U-shaped support such as (43) (44) Anti-inflammatory hyperplasia and suppression connective tissue proliferation drug loading play slow Slow release into biodegradable polymer Effect.

The U-shaped connection of support is disconnected as (45) (46) (47) (48) in support, so that leading portion is when air bag (5) is inflated There are 3 and the above is opened in petal specimen page, (49) (50) disconnect the U-shaped connection of support in support, so that back segment is inflated in air bag (7) When up and down separate.

The both ends of the S connections of stage casing support are connected by rotatable rotating shaft, stage casing when outwards being turned right by (12) (14) Support can extend, to adapt to the patient of different sinus length.

Claims (9)

1. biodegradable carrying drug stent is inserted nasal sinus sinus and open sinus and drain by one kind reaches treatment acute and chronic nasal sinus Scorching method, and to complete the therapeutic system that this treatment method uses, it is characterised in that:First with surface anaesthetic by nasal cavity Surface anesthesia, carry Fig. 1 devices by nasal endoscopes and enter nasal sinus sinus cavities, fester suction and sinus are completed by (1) (24) (25) in Fig. 1 Chamber is rinsed, and nasal sinus road surrounding mucosa congestion and edema is disappeared as the medicine entrained by (2) (10), and table is removed by (16) and (17) Face overlay film (9), make air bag (5) inflation by (26), leading portion support is in petal opening, and the slightly outside pumpback of device makes The petal support of leading portion is affixed with sinus mouth inwall, makes air bag (6) inflation by (27), support stage casing is opened, and passes through guide rod (12) length in (14) adjustment support stage casing, makes air bag (7) inflation by (28), opens holder back section, in reaching Concha and concha nasalis inferior separation or sphenoid sinus outlet butterfly pharyngeal recess are opened, and the gas in (5) (6) (7) is extracted out by (26) (27) (28), Extract stent conveying device out, complete inserting for support, can be taken when Fig. 1 devices are sent into sinus cavities by nasal endoscopes using Fig. 5 Band or the direction for changing Fig. 1 devices.
2. according to Fig. 1 devices described in claim 1, it is characterised in that:The front end of pipeline (1) by lateral opening flexible material Be made, be connected with pipeline below, it is spaced intermediate formation 2 pipelines, end (24) (25) can connect syringe, respectively and Two pipelines communicate, and suction out the fester in sinus cavities with syringe and injection flushing liquor rinses.
3. according to Fig. 1 devices described in claim 1, it is characterised in that:(2) it is made up of, and carries the silk floss material of somewhat resilient Topical anesthetic and the medicine for making nasal mucosa vesselses smooth muscle contraction, shape such as hemispherical or bullet-headed, bonded with pipeline (4) Integrally, 2 more than annular shell fragments are connected with (2) (4) inside it.
4. according to described in claim 1, it is characterised in that:Overlay film 9 is wrapped in outside part (2) and support, surface silk floss coating (10) carrying makes the medicine and corticosteroid medication of nasal mucosa vesselses smooth muscle contraction.
5. according to described in claim 1, it is characterised in that:Change Fig. 5 devices of Fig. 1 device directions of advance, be both ends open Hollow tube made of non-elastic material (30), the semicanal of one end are bent in 30-45 degree, the side connection annulus (32) of hollow tube, It is made up of elastomeric material, another end opening of annulus, annulus can be made to be stuck in securely on nasal endoscopes (34), or is carried and schemed by nasal endoscopes With (30) and (32), difference is that (31) are hollow straight tubes, only carries and makees for (31) and (33) of 1 device, material and connected mode With.
6. according to described in claim 1, it is characterised in that:Hollow tube (4) in Fig. 2, is separated by cross-section, forms internal independence not 3 pipes communicated, communicate (5) and (26), and (6) and (27) communicate, and (7) and (28) communicate, and in (26), (27), (28) (22 (23) must have enough toughness and elasticity to air bag (21), can probably estimate the pressure in (5) (6) (7) air bag.
7. according to described in claim 1, it is characterised in that:Fig. 1 devices enter sinus cavities, after sinus cavities are rinsed, remove blade (17) Outer protective case (18), with (16) by (9) to recession, splitted in overlay film pumpback by blade, until removing whole overlay film (9), cruelly There is baffle plate (15) dew support and guide rod (12) (14), support outer end, and guide rod passes through baffle plate.
8. according to described in claim 1, it is characterised in that:Fig. 7 support is made up of synthesizing biological degradable high polymer material, Slow-absorbing in sinus passages, -3 years half a year of time limit is absorbed, except leading portion connects such as (41) (42) with the row's S types of back segment the 3rd in support In do not contain by slow releasing pharmaceutical of the biodegradated polymer materal as carrier, in remaining S types connection and U-shaped support such as (43) (44) There is anti-inflammatory hyperplasia and suppress connective tissue proliferation drug loading into biodegradable polymer, play slow release The effect of medicine.
9. according to described in claim 8, it is characterised in that:By the U-shaped connection of support as (45) (46) (47) (48) in support Disconnect, so that leading portion there are 3 when air bag (5) is inflated and above petal specimen page is opened, the both ends of the S connections of stage casing support are by that can turn Dynamic rotating shaft connection, holder back section (49) (50) disconnects the U-shaped connection of support, so that back segment opens when air bag (7) is inflated.
CN201710668471.3A 2017-08-07 2017-08-07 Biodegradable stent in the treatment paranasal sinusitis is built into nasal sinus road by a device CN107485472A (en)

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