CN107847713A - Eustachian tube dilating sacculus with ventilation path - Google Patents

Eustachian tube dilating sacculus with ventilation path Download PDF

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Publication number
CN107847713A
CN107847713A CN201680031186.4A CN201680031186A CN107847713A CN 107847713 A CN107847713 A CN 107847713A CN 201680031186 A CN201680031186 A CN 201680031186A CN 107847713 A CN107847713 A CN 107847713A
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CN
China
Prior art keywords
eustachian tube
expander
tube
patient
main body
Prior art date
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Pending
Application number
CN201680031186.4A
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Chinese (zh)
Inventor
P.F.坎贝里
D.T.哈菲
H.V.哈
K.P.穆尼
A.阮
S.林
J.Y.常
E.戈德发布
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Acclarent Inc
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Acclarent Inc
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Priority claimed from US14/674,639 external-priority patent/US10206821B2/en
Application filed by Acclarent Inc filed Critical Acclarent Inc
Publication of CN107847713A publication Critical patent/CN107847713A/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00082—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/227—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A61F11/20—Ear surgery
    • A61F11/202—Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A61F11/20—Ear surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Acoustics & Sound (AREA)
  • Otolaryngology (AREA)
  • Psychology (AREA)
  • Surgical Instruments (AREA)

Abstract

The present invention provides a kind of device, and described device includes axle, expandable stent (1850) and at least one ventilation path (1855).The axis limit longitudinal axis and including with least one shaft lumen (1853) distal end and proximal end.The expandable stent includes the main body of proximal end and distal end (1856,1851) with its own.The main body is configured to change between contraction state and swelling state.The main body is configured to expand the Eustachian tube of patient in the expanded state.At least one ventilation path is configured to when the main body is in swelling state, there is provided the ventilation of the proximal end from the distal end of the main body to the main body.In some instances, the ventilation path includes the vent openings of the one group of horizontal orientation formed by the axle.In some other examples, the space between the structure that the ventilation path projects radially outwardly including being limited to the one or more of the expandable stent.

Description

Eustachian tube dilating sacculus with ventilation path
Background technology
The present invention relates to for enter, diagnose and treat middle ear and Eustachian tube in target tissue region method and system.
Referring to figs. 1 to Fig. 2, ear 10 is divided into three parts：External ear 12, middle ear 14 and inner ear 16.External ear 12 includes poly- Collection sound and the auricle by sound towards eardrum 22 (also referred to as ear-drum) guiding being positioned at the inner end 24 of duct 20 18 and duct 20.Middle ear 14 are located between external ear and inner ear 12 and 16 and the rear portion of larynx are connected to by Eustachian tube 26, pharynx drum Pipe 26 is used as the equalizing valve between ear 10 and nasal sinus.The distal openings 28 that Eustachian tube 26 is terminated in the nasopharyngeal area 30 of larynx 32 In.In addition to ear-drum 22, middle ear 14 also include three small oticas (phonophore)：(the malleus of malleus (malleus) 34 (hammer)), incus (incus) 36 (incus (anvil)) and stapes 38 (stapes) (stapes (stirrup)).These bones 34- Acoustical vibration is transferred to inner ear 16 and is thus used as converter by 38, the acoustical vibration in the duct 20 of external ear 12 is converted into interior Fluid wave in ear 16.These fluid waves stimulate some nerve endings 40, and nerve endings 40 is then by acoustic energy transmissions to brain, sound It can be interpreted in the brain.
Eustachian tube 26 is 1.5 inches of narrow long paths, path connection middle ear 14 and nasopharynx 30, i.e. maxilla in nose rear portion Top larynx region immediately above.Eustachian tube 26 is used as the equalizing valve of middle ear 14, and middle ear 14 are normally filled with air.Acted as when normally Used time, Eustachian tube 26 in response to swallow or yawn periodically (about every three minutes once) open to some points of one second it It is several.Middle ear 14 are so allowed air into replace the air absorbed by middle ear lining (mucous membrane), or balance in height above sea level The pressure change occurred during change.Any factor for hindering this periodicity of Eustachian tube 26 to open and close can cause hearing Damage or other ear's symptoms.
The obstruction of Eustachian tube 26 or blocking cause the negative pressure of middle ear 14, and its ear-drum 22 bounces back (suction).In adult, This generally entails uncomfortable certain ear, inflation sense or feeling of stress, and can cause slight hearing impairment and head noise (ear Ring).Can there is no symptom in children.If lasting obstruction, fluid can be extracted from the mucous membrane of middle ear 14, so as to produce referred to as The illness of otitis media serosa (fluid in middle ear).This illness can be frequently occurred in children with reference to the infection of the upper respiratory tract, And the reason for being the hearing impairment associated with the illness.
The film connection of the lining form of middle ear 14 and Eustachian tube 26 (mucous membrane) and nose 42, nasal sinus 44 and larynx 32 is simultaneously identical.These areas The infection in domain causes mucous membrane swelling, and mucous membrane swelling can then cause the obstruction of Eustachian tube 26.This is referred to as being acute or slow The aggregation of the otitis media serosa, i.e. fluid substantially in middle ear 14 of property, this distal side for being often as Eustachian tube 26 is opened The blocking of mouth 28, the blocking allow fluid accumulation in middle ear 14.In the presence of bacterium, this fluid can be infected, So as to cause acute suppurative otitis media (middle ear of infection or abscess).If do not infected, fluid exists, until pharynx Tympanic canal 26 starts again at proper function, and now, fluid is absorbed or drains into larynx 32 downwards along pipe by Eustachian tube opening 28 In.
Chronic serous otitis media can be blocked and caused by long-term Eustachian tube, or be thickened by fluid so that it can not be inhaled Receive or cause along the drainage downwards of Eustachian tube 26.This chronic disease is generally associated with hearing impairment.Recurrent ear may be present Bitterly, especially when individual is caught a cold.Fortunately, otitis media serosa is sustainable for many years, is manufactured into and appoints without centering earphone What permanent lesion.However, the presence of the fluid in middle ear 14 makes it be highly susceptible to the influence of Recurrent Acute infection.These are multiple The sexy dye of hair can cause the infringement to middle ear.
When Eustachian tube 26, which includes fluid, to be gathered, many situations can occur.First, body absorbs the sky from middle ear 14 Gas, so as to result in vacuum, this vacuum is tended to inwardly draw lining form and ear-drum 22, so as to cause pain.Next, body Vacuum is replaced with more fluids, this tends to mitigate pain, but patient can be subjected to the sensation of inflation in ear 10.With anti- Histamine drug and decongestant, which treat the illness, can need several weeks just to take effect completely.Finally, fluid can be infected, this sense Dye can be pain and patient is not felt well, and patient can be caused to hear sound well.If inner ear 14 is by shadow Ring, patient can feel rotation sense or sense of rotation (dizziness).The logical common antibiotics treatment of infection.
However, even if treat infection or the other reasons in middle ear 14 using antihistamine, decongestant and antibiotic Caused fluid accumulation, these treat pain and discomfort caused by the fluid accumulation that will not generally solve immediately in middle ear 14； I.e. if can remove fluid from Eustachian tube 26, then patient will feel that most direct alleviation.
The antibiosis extract for treating of middle ear infection generally produces normal middle ear function in three to surrounding.During healing, suffer from Person can undergo different degrees of ear pressure, sonic boom, click and sense of hearing fluctuation, once in a while with lightning pains in ear.The solution of infection is once in a while The fluid being uninfected by of patient is stayed in middle ear 14, locally lie in Eustachian tube 26.
Operative treatment has been used in past fluid accumulation as caused by the infection of these types.In operative treatment serosa chronica The main purpose of otitis is to re-establish middle ear ventilation, keeps hearing normal level, and prevents from damaging eardrum and middle otica Recurrent infection.
For example, as shown in figure 3, tympanotomy can be performed to discharge the fluid in middle ear 14.Tympanotomy is held Behavior forms otch 42 in ear-drum 22, to remove the fluid in middle ear 14.The hollow plastic pipe 44 for being referred to as breather pipe is inserted Enter and be placed in otch 42 to prevent otch 42 from healing and ensure the ventilation of middle ear 14.Breather pipe 44 substitutes Eustachian tube 26 temporarily Pressure in balanced middle ear 14.Breather pipe 44 generally remain in position in three to nine months, Eustachian tube 26 is stifled during this period Plug disappears.When removing pipe 44, ear-drum 22 heals；Then Eustachian tube 26 recovers the function of its normal counterpressure.
Figure 4 illustrates wherein hypodermic syringe needle 46 is logical by driving for another method of pressure in release middle ear 14 Ear-drum 22 is crossed, the fluid of any accumulation is generally only extracted out from the upper part of Eustachian tube 26 by hypodermic syringe needle 46.
Fig. 3 and Fig. 4 method, which is related to, ruptures ear-drum 22 to alleviate fluid accumulation and the pressure increase in middle ear.Except Sometimes outside permanent puncture caused by ear-drum 22, any one of these methods are all in Eustachian tube 26 is removed It is not particularly effective during fluid, because the lower end 28 of Eustachian tube 26 is usually by fluid blockage and stop.
With reference to above-mentioned Fig. 3 and Fig. 4 surgical intervention, the inflation of Eustachian tube 26 also be used to alleviate pressure as shown in Figure 5 Accumulation and fluid accumulation.Syringe 46 (being shown as with flexible end 48) is inserted in nostril or mouth, until end 48 The distal openings 28 of Eustachian tube 26 in the nasopharyngeal area 30 of neighbouring larynx 32 position.Air is blown via syringe 46 by end 48 Enter in the Eustachian tube 26 being blocked, and be therefore blown into middle ear 14, to help to alleviate congestion and re-establish middle ear ventilation.Should Code is commonly known as politzerization.When one in nostril be pinched and patient while when swallowing (as shown in Figure 6), middle ear Air blast is maximally effective.This forces the air into Eustachian tube 26 and middle ear 14.The technology is beneficial for opening Eustachian tube 26 , but it does not remove the fluid of accumulation.
Another method for (temporarily, at least) cleaning middle ear 14 is referred to as " Wa Er Sa Erwashi (valsalva) " Method, it is forcibly blowed air into middle ear 14 to complete by patient while nose is pinched, and this method is generally claimed To wash ear open.This method is also advantageous for opening Eustachian tube 26, but it does not remove the fluid of accumulation yet.
The Typical obstacles associated with middle ear and Eustachian tube include tympanic member perforation, tympanosclerosis, incus corrosion, tympanitis, Cholesteatoma, mastoiditis, abnormalpatencyofeustachiantube and conductive hearing loss.In order to treat some in these obstacles, can hold Row ear surgical operation.Most of ear's surgical operations are the microsurgeries performed with surgical operation microscope.Ear's surgery hand The type of art includes stapedectomy, myringoplasty, tympanotomy and syrinx surgical operation.
One in simplest ear's surgical operation is tympanotomy or ear-drum otomy.However, ear's surgery hand Art may also require that removal eardrum, the visualization for middle ear space.Usual surgeon will attempt to pass through the skin in duct In do otch and remove eardrum as complete overall to retain the integrality of eardrum.Alternatively, realized via mastoid process in entering Ear.This method is bored into middle ear behind ear close to middle ear space, and by mastoid process air chamber.Whether external auditory meatus and mastoid process are removed Between bone separator depend on disease degree.Refer to through (Canal-wall-down) under tube wall and remove the bone separator.Through pipe (Canal-wall-up), which refers to, on wall keeps the bone separator complete.Term modified radical mastoidectomy refers to the wherein bone separator quilt Remove and rebuild ear-drum and the operation of phonophore.Mastoidotympanectomy be wherein remove the bone separator and forever remove ear-drum, Malleus and incus so that can safely clean the operation of the liner of big cholesteatoma capsule.When running into large area cholesteatoma or courage When lipoma is adhered to inner ear or face nerve, the operation is carried out.
The slight illness of middle ear and Eustachian tube is very universal and is serious medical problem, annoyings millions of people and draws Play pain, even discomfort, hearing loss or the infringement of permanent ear.Although many kind treatments are developed, as described above Each of which has the disadvantage in that.Accordingly, there exist to for enter, diagnose and treat middle ear and Eustachian tube in targeted tissue areas The demand of the improved method and system in domain.It is desirable that such method and system will be minimally invasive and to healthy ear tissue Hurtful risk is very small.
The content of the invention
Embodiment of the present invention be related to for enter, diagnose and treat middle ear and Eustachian tube in target tissue region side Method and system.
In one aspect, the present invention is provided to the method for the Eustachian tube for entering patient.This method can relate to lead guiding In the nasal passage of pipe insertion patient, the guiding catheter has distal end, and the distal end has bending section, wherein bending section With the angle between 30 degree and 90 degree；And make guiding catheter opening towards the Eustachian tube in nasopharynx in nasal passage Mouth is promoted, and distal end is placed adjacent to Eustachian tube opening.
In one embodiment, this method, which may also include, promotes diagnostic device by guiding catheter with by diagnostic device Distal end is placed adjacent to Eustachian tube opening.Diagnostic device can be conduit or endoscope.
In another embodiment, this method can relate to diagnostic probe being introduced into Eustachian tube, directly to assess pharynx drum Pipe function.Diagnostic probe can be made up of flexibility and the material compatible with Eustachian tube.Diagnostic probe can be the pressure on seal wire Transducer.This method may also include the pressure monitored when patient swallows in Eustachian tube, and use monitoring and evaluation patient's The opening function of Eustachian tube.
In one embodiment, this method may also refer to remove after diagnostic probe is placed into Eustachian tube and guide Conduit.
In one embodiment, diagnostic probe may include ultrasonic probe.
In another embodiment, this method may also refer to promote therapeutic equipment by guiding catheter towards Eustachian tube, The distal end of therapeutic equipment is placed with neighbouring Eustachian tube opening.Therapeutic equipment may include the impermeable distal member of ray.Control Treating equipment may include conduit.The fluid that therapeutic equipment may also include in the middle ear space of the ear for introducing fluid into patient draws Enter equipment.This method may also refer to using ultrasonic device scanning middle ear space.Fluid can be air, contrast agent, suction fluid, or Medicine.
In another embodiment, therapeutic equipment may include for the pumping equipment from middle ear space suction material.
In another embodiment, this method may also refer to introduce protection equipment in Eustachian tube nearside, and use guarantor Protect the propulsion of monitoring of equipment therapeutic equipment.In one aspect, protection equipment may include the sensor for being positioned at eardrum nearside, with The position of therapeutic equipment is sensed during propulsion.Protection equipment may include endoscope and be promoted with visualizing.
On the other hand, the present invention is provided to the method for the eustachian tube function of indirect assessment patient's body.This method can It is related to the locating energy transmitter in the nasopharynx of neighbouring European pipe；Via external auditory meatus adjacent to eardrum locating energy receiver；By energy Amount guides from transmitter towards receiver；Generation represents the launcher signal of the energy from transmitter；Generation is represented by launching The recipient signal for the energy that device receives；It is contrasted between launcher signal and receiver signal；And use the contrast Function of the indirect assessment Eustachian tube during swallowing.
In one embodiment, indirect assessment can relate to estimate the physical characteristic of Eustachian tube.
In another embodiment, energy emitter can in the form of pressure wave or electromagnetic energy emitted energy.
On the other hand, the present invention is provided to the method for the Eustachian tube for treating patient's body.This method can relate to via Seal wire is placed into the Eustachian tube of patient by the nasopharynx of patient；Excision equipment is introduced into the Eustachian tube of patient along seal wire；And Being removed from the surface of the side along Eustachian tube includes the edematous tissue of hypertrophica mucous membrane.
In one embodiment, seal wire may include to mark, and this method may also refer to provide and be introduced into Eustachian tube Relevant feedback.
On the other hand, the present invention is provided to the method for the Eustachian tube for treating patient's body.This method can relate to via The nasopharynx of patient introduces seal wire between the cartilage and mucomembranous surface of Eustachian tube under mucous membrane；Excision equipment is introduced along seal wire and swallowed In the submucous tissue between cartilage and mucomembranous surface of tympanic canal；And remove some submucous tissues.
On the other hand, the present invention is provided to the muscle dysfunction for the Eustachian tube for treating patient's body or anatomical to hinder The method hindered.This method can relate in tensor veli palatini (tensor veli palatini muscle) or levator muscle of palatine velum At least one middle formed in (levator veli palatini muscle) melts stove, to be influenceed when melting stove reabsorption (one or more) muscle is put more energy into.
In one embodiment, put more energy into the tensor veli palatini or levator muscle of palatine velum that may include to shorten or be tensioned.
In another embodiment, the generation for melting stove can relate to apply and be controlled selected from mechanotherapy, laser therapy, radio frequency Treat the treatment with chemotherapy.
On the other hand, the present invention is provided to the method for the Eustachian tube for treating patient's body.This method can relate to will be double Tube chamber pressure equalization tube is placed by the eardrum of patient, and the pipe has the distal side extension for being used to position in the region of Eustachian tube Portion；By the first tube chamber of the two-tube lumen being in fluid communication with distal side extension medicine is provided to the region of Eustachian tube；It is and logical The second tube chamber for crossing two-tube lumen provides the ventilation for crossing over eardrum.
In one embodiment, medicine can be configured to reduce the oedema in Eustachian tube region.Medicine can include table Face activating agent, surfactant is configured to change the surface tension of the mucous layer of Eustachian tube, to realize mucous membrane table using medicine The wetting of the enhancing in face.
In one embodiment, medicine, which can include, is configured for by the particle of the mucosal tissue capture of Eustachian tube, To realize the sustained release of medicine.
In one aspect, the present invention is provided to the device for the Eustachian tube for treating patient's body.The device may include to be used for The two-tube lumen inserted in the eardrum of the ear of patient, the pipe have：For the distal side extension being placed in the region of Eustachian tube Portion；For the first tube chamber of medicine to be provided to the region of Eustachian tube by distal side extension；And for providing across eardrum Second tube chamber of ventilation.
In one embodiment, the first tube chamber may be provided in the second tube chamber.On the other hand, the second tube chamber can be set In the first tube chamber.It yet still another aspect, the first tube chamber can neighbouring second tube chamber setting.
In another embodiment, two-tube lumen can be made up of biodegradable bioabsorbable material.
On the other hand, the present invention is provided to the method for the Eustachian tube for treating patient's body.This method may involve the use of Guiding piece with tube chamber enters Eustachian tube region via nasopharynx；Seal wire is introduced by the tube chamber of guiding piece, by seal wire viscous It is positioned under film between the cartilage of Eustachian tube and mucomembranous surface；Make the interim tube chamber implant edge with medicine delivery reservoir Seal wire is passed through, and implant is positioned in the rear pad in the Eustachian tube region between tube chamber and cartilage under mucous membrane；And from medicine Thing delivering reservoir delivers the medicament to Eustachian tube region.
In one embodiment, this method may also refer to medicine being delivered to proventriculus type from medicine delivery reservoir simultaneously With Eustachian tube region.
In one embodiment, medicine delivery reservoir may include to set coating over the implant.
In another embodiment, guiding piece can be made up of biodegradable bioabsorbable material.
On the other hand, the present invention is provided to the method for the Eustachian tube for treating patient's body.This method can relate to via Nasopharynx, which is realized, enters Eustachian tube region；It is introduced into via the nasopharynx of patient and is designed to stretch into hollow seal wire in Eustachian tube region, The hollow seal wire includes being arranged on multiple holes at or near its distal end；And patient is delivered drugs into by hole Ear Eustachian tube or middle lug areas in it is at least one.
On the other hand, the present invention is provided to the system for the Eustachian tube for entering patient.The system may include guiding piece, should Guiding piece is arranged to penetrate in the nasal passage of patient so that the distal end of conduit is positioned at Eustachian tube or near it, The guiding piece has distal end, and the distal end has bending section, and bending section has the angle between 30 degree and 90 degree； And seal wire, it is configured to enter Eustachian tube through guiding piece.
In one embodiment, guiding piece may include conduit.
In another embodiment, guiding piece may include two-tube lumen.
In another embodiment, system may also include the diagnostic device being arranged to through guiding piece.
In another embodiment, system may also include the therapeutic equipment being arranged to through guiding piece.
On the other hand, the present invention is provided to treat the equipment of Eustachian tube.The equipment may include elongated stiff shaft.Should Equipment may also include the elongated and flexible insert for being couple to axle, and the insert includes being used for the elongated portion for treating Eustachian tube Therapeutic equipment, the insert includes entering the lateral rigidity of horizontal deflection according to Eustachian tube, and allows insert to be pushed into pharynx drum Without the column stiffness of warpage in pipe.
In one embodiment, elongated rigid axle may include distal end, and it has in the range of 30 degree to 90 degree Bending section.
In one embodiment, elongated rigid axle may include proximal end, and proximal end may include to be used for insert At least one fluid accessories of supply fluid.
In one embodiment, elongated rigid axle may include the tube chamber for passing through seal wire.
In one embodiment, insert may include flexible cored wire.
In one embodiment, flexible cored wire can be made up of superelastic alloy.
In one embodiment, flexible cored wire may include in the hurtless measure end of the farthest side portion of insert.
In one embodiment, therapeutic equipment may include sacculus.
In one embodiment, sacculus may include microcellular structure.
In one embodiment, the preformed shape that Balloon-expandable matches to the profile with Eustachian tube.
In one embodiment, sacculus may include medication coat.
In one embodiment, medication coat can be steroids, antibiotic, antifungal agent, non-steroidal anti-inflammatory agent, steroidal One kind in antiinflammatory, surfactant or anti-stick membrane substance.
In one embodiment, therapeutic equipment be able to can be pulled down from stiff shaft.
In one embodiment, therapeutic equipment may include tube chamber.
In one embodiment, therapeutic equipment can be biodegradable and may include therapeutic substance.
In one embodiment, therapeutic substance can be steroids, antibiotic, antifungal agent, non-steroidal anti-inflammatory agent, steroidal One kind in antiinflammatory, surfactant or anti-stick membrane substance.
In one embodiment, therapeutic equipment may include expandable stent.
In one embodiment, expandable stent may include therapeutic substance.
On the other hand, the present invention is provided to the method for the Eustachian tube for expanding patient.Guiding catheter can be pushed through The nasal passage of patient, at or near the opening for the Eustachian tube that the distal end of guiding catheter is positioned to patient.Guiding is led The distal part of pipe may include the bending section with the angle between 30 degree and 90 degree.Distal part is than guiding catheter Portions of proximal is more flexible.Seal wire can be pushed through guiding catheter so that the distal end of seal wire enters Eustachian tube.It can lead Promote dilating catheter that the expander of dilating catheter is positioned in Eustachian tube on silk.Expander may expand to expand Eustachian tube. Dilating catheter and seal wire can be removed from patient's body.
In one embodiment, the distal part of guiding catheter can be ductility, and bending in distal part Portion can be formed by the user of guiding catheter.
In one embodiment, the opening of Eustachian tube may include the pharynx mouth of Eustachian tube, and dilating catheter can be pushed into So that expander is positioned in pharynx mouth.
In one embodiment, seal wire can be illuminating guidewire.Light can be launched from illuminating guidewire, and observable transmitting Light.
In one embodiment, the light for the endoscopic observation transmitting being positioned in the head of patient can be used.
In one embodiment, guiding catheter is moved from patient's body before dilating catheter being promoted on seal wire Remove.
In one embodiment, dilating catheter can be advanced to and through guiding catheter on seal wire.Removing step can wrap Include from patient's body and remove guiding catheter.
In one embodiment, dilating catheter may include sacculus dilating catheter, and make expander expansion may include to make The balloon inflation of sacculus dilating catheter.
In one embodiment, balloon inflation is made to make the stent expansion in Eustachian tube.
In one embodiment, dilating catheter may include flank, and expander expansion is may include using flank Maintain the position of sacculus.
In one embodiment, sacculus can shape in inflation, with the taper hole phase of the pharynx mouth with Eustachian tube ET Match somebody with somebody, and expander expansion is may include the intraoral expansion of pharynx for making sacculus in Eustachian tube ET.
In one embodiment, sacculus can be formed to have the cross section for preventing take up whole Eustachian tube, and make expansion Prop expansion may include to maintain sacculus in position to discharge the pressure in Eustachian tube.
In one embodiment, sacculus may include cutting element, and make expander expansion may include to use cutting element Cut tubal wall.
In one embodiment, endoscope can be pushed through nasal passage, and endoscopic observation expansion can be used Conduit.
In one embodiment, the mark on axle of the dilating catheter including observation conduit is observed.Expander is relative to pharynx The position of the opening of tympanic canal can be approached based on the distance of proximal end of the mark away from expander.
In one embodiment, it can be used expander that at least one material is applied into Eustachian tube.
In one embodiment, expander may include the porous sacculus for delivered substance.
In one embodiment, expander may include the sacculus with multiple pins for delivered substance.
In one embodiment, dilating catheter can be against Eustachian tube applying power, to maintain expander during expansion Position.
On the other hand, the present invention is provided to the method for the Eustachian tube for expanding patient.Guiding catheter can be pushed through The nasal passage of patient, the distal end of guiding catheter is positioned at the Eustachian tube of patient opening or its near.Guiding The distal part of conduit may include the bending section with the angle between 30 degree and 90 degree.Distal part is than guiding catheter Portions of proximal it is more flexible.Delivery catheter can be pushed through guiding catheter, and delivery catheter is placed in Eustachian tube.Can Elongated material delivery device is delivered in Eustachian tube using delivery catheter.Dilating catheter and seal wire can be moved from patient's body Remove, while elongated drug delivery device is stayed in Eustachian tube.
In one embodiment, elongated material delivery device can be to be configured to elute the thin of at least one therapeutic substance Long filament.
In one embodiment, delivering elongated material delivery device may include inside delivery catheter to tear elongated filament open Under.
In one embodiment, delivering elongated material delivery device may include outside delivery catheter to tear elongated filament open Under.
In one embodiment, elongated material delivery device can be the ball for being configured to eluted material over time Capsule.
In one embodiment, deliver the inflation that elongated drug delivery device may include to make sacculus in Eustachian tube and Sacculus is set to depart from delivery catheter.
In one embodiment, sacculus can be configured to allow the pressure in Eustachian tube balanced.
In one embodiment, elongated drug delivery device can be expandable stent.
In one embodiment, delivering elongated drug delivery device may include to insert expandable stent in Eustachian tube simultaneously And the proximal end of expandable stent is not constrained, to allow the proximal end of expandable stent to be expanded in Eustachian tube.
In one embodiment, elongated drug delivery device can be oblong insert, and oblong insert includes being connected to The elongated center component of multiple support members, and each support member may be connected to elongated external member.
In one embodiment, support member can provide and maintain the open space in Eustachian tube, to maintain pressure therein Power is balanced.
On the other hand, the method for the Eustachian tube for expanding patient can relate to：Expansion device is promoted by patient's Nasal passage, the expander of equipment is positioned at least partially in the Eustachian tube of patient；Expander expansion is set to expand pharynx A part for tympanic canal；Expander is set to collapse；And expansion device is removed from patient's body, wherein after removing device, pharynx drum The expansion of pipe keeps at least partly expanding.In one embodiment, the distal part of expansion device can be ductility, And this method may also refer to form bending section in distal part by the user of expansion device.In the embodiment or alternative In embodiment, the distal part of expansion device may include in the bending section between about 30 degree and about 90 degree.In some realities Apply in scheme, the opening of Eustachian tube is the pharynx mouth of Eustachian tube, and expansion device is pushed into so that expander is positioned in pharynx mouth.
In one embodiment, expansion device may include the leader being slidably coupled with expander.It is real herein Apply in scheme, promote expansion device to can relate to expansion device being advanced in nasal cavity, the distal end of equipment is positioned at pharynx At or near the opening of tympanic canal, and expander is promoted relative to leader, by expander positioning in the opening.In a reality Apply in scheme, leader may include outer tube and extend beyond the interior axle of outer tube laterally, and expander can by pipe and It is pushed on interior axle.In one embodiment, interior axle can be ductility, and this method also includes by expansion device User forms bending section in interior axle.
In some embodiments, expander can be sacculus, and make expander expansion can relate to make balloon inflation.One In individual embodiment, balloon inflation is set to make the stent expansion in Eustachian tube.In one embodiment, sacculus may include to cut Component, and make expander expansion may also refer to cut tubal wall with cutting element.
Optionally, this method may also include by endoscope promote by nasal passage and using endoscopic observation promote, Expand, collapse or remove and be in step at least one.In one embodiment, observation may include to observe the mark on expansion device Note.In this embodiment, this method may also include based on proximal end of the mark away from expander apart from Approximation Extensions device phase For the position of the opening of Eustachian tube.
In one embodiment, this method may also include is applied to Eustachian tube using expander by least one material. In one embodiment, expander can be the porous sacculus for delivered substance.In another embodiment, expander can For the sacculus with multiple pins for delivered substance.
On the other hand, the equipment of the Eustachian tube for expanding patient may include shank, with shank coupling guiding elements, It is slidably coupled with shank and is arranged on the expander at least a portion of guiding elements, the edge that is used on shank is drawn The actuator that component promotes expander is led, and the expansion member for allowing expander to expand is coupled with shank.In a reality Apply in scheme, expander may include foley's tube, and foley's tube includes inflatable sacculus, and expansion member may include and sacculus The inflation aperture that the inflation tube chamber of conduit is in fluid communication.In one embodiment, sacculus may include multiple holes, a kind of or more Kind medicine may pass through the hole to contact Eustachian tube.In the embodiment or another embodiment, sacculus may include at least One cutting element for being used to cut the tissue in Eustachian tube in expansion.
In some embodiments, guiding elements may include axle, and expander slides on the axle.In some embodiments In, axle is ductility.In the embodiment or other embodiments, axle can have a bending section, the bending section have between Angle between about 30 degree and about 90 degree.In some embodiments, the distal end of axle can have bulb.
In some embodiments, propulsion member includes sliding block.In some embodiments, expander may include that rigidity is near Side part and flexible distal section.In one embodiment, rigid portions of proximal may include hypotube.In an embodiment In, guiding elements may include tubulose axle, and expander is slided by the tubulose axle.In one embodiment, the axle can be to extend Property.In addition or alternatively, axle can have bending section, and the bending section has the angle between about 30 degree and about 90 degree Degree.
Optionally, equipment may also include be arranged on shank and with the suction lumen fluid through guiding elements or expander The suction orifice of connection.Optionally in addition, equipment may also include for endoscope to be connected into structure with the endoscope that the equipment couples Part.
For a further understanding of the property and advantage of the present invention, following description should be referred to reference to accompanying drawing.It is each in accompanying drawing It is provided merely for the purpose for illustrating and describing, and is not intended to limit the scope of embodiment of the present invention.
Brief description of the drawings
Fig. 1 is the cross section of human ear, and it shows inner ear, middle ear and burr and Eustachian tube, and Eustachian tube is remote via its Side opening connects the nasopharyngeal area of middle ear and larynx.
Fig. 2 is the cross section of head part, and it shows to include the larynx shown in Fig. 1 of the distal openings of the Eustachian tube shown in Fig. 1 Nasopharyngeal area.
Fig. 3 is that it shows the existing skill for discharging the fluid in middle ear in the cross section of the human ear of orientation shown in Fig. 1 The surgical method of art, its Center Vent tube are placed in the otch in eardrum.
Fig. 4 is that it shows the existing skill for discharging the fluid in middle ear in the cross section of the human ear of orientation shown in Fig. 1 The surgical method of art, instrument used for injection shown in it have the pin for penetrating eardrum.
Fig. 5 to Fig. 6 shows that it is shown for discharging the stream in middle ear in the cross section for the head part being orientated shown in Fig. 2 The politzerization of the prior art of body, instrument used for injection shown in it have the flexible end extended in nose and/or larynx region to make Obtain the pharynx mouth that end abuts Eustachian tube when nose is plugged.
Fig. 7 shows the sectional view of head part, and it shows nasopharyngeal area and guiding catheter in nasal passage, wherein leading The distal end of pipe is adjacent to Eustachian tube opening.
Fig. 8 shows the section of the anatomic region around Eustachian tube (ET).
Fig. 9 shows the section of the anatomic region around Eustachian tube, its show cut off ET around edematous tissue diagnosis or Treatment protocol.
Figure 10 shows the section of the anatomic region around Eustachian tube, and its alternative of edematous tissue for showing to cut off around ET is controlled Treat code.
Figure 11 is shown for delivering medicament to treat the illustrative drug delivery system of ET inflammation or oedema.
What Figure 12 showed to provide by nasopharynx is used to deliver medicament to treat the alternative medicine delivery of ET inflammation or oedema System.
Figure 13 shows the section of the anatomic region around ET, and it shows that the equipment of the pharynx mouth by being inserted through Eustachian tube performs Diagnosis or treatment protocol.
Figure 13 A show in Figure 13 with dotted line enclose come region zoomed-in view.
Figure 13 B show the front view of head part, and a part for its septum reset is removed to show seal wire introducing Eustachian tube In method embodiment.
Figure 14 A to Figure 14 D show the various examples that can be located at the diagnosis in Figure 13 or the operation element on therapeutic equipment.
Figure 15 A and Figure 15 B show the side view of the example devices for providing treatment to Eustachian tube.
Figure 15 C to Figure 15 E show the sectional view of the example devices for providing treatment to Eustachian tube.
Figure 15 F show the side front view of the expansion device for providing treatment to Eustachian tube.
Figure 16 A and Figure 16 B show the partial cross-section of the equipment used in the method for treating the Eustachian tube of patient.
Figure 17 A show the front view of the illuminating guidewire for treating Eustachian tube when patient's body uses.
Figure 18 A and Figure 18 B show the partial cross-section of the equipment used in the method for treating the Eustachian tube of patient.
Figure 18 C show the partial cross-section of the equipment used in the method for treating the Eustachian tube of patient.
Figure 18 D show the partial cross-section of the equipment used in the method for treating the Eustachian tube of patient.
Figure 18 E show the side view of the expander for providing therapeutic agent to the Eustachian tube of patient.
Figure 18 F show the perspective view of Figure 18 E expander.
Figure 18 G show sectional view of Figure 18 E expander in the Eustachian tube of patient, and wherein expander is in expansion shape State.
Figure 18 H show the side view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 I show the perspective view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 J show sectional view of Figure 18 I expander in the Eustachian tube of patient, and wherein expander is in expansion shape State.
Figure 18 K show the side view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 L show the perspective view of Figure 18 K expander.
Figure 18 M show the side view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 N show the perspective view of Figure 18 M expander.
Figure 18 O show the side view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 P show the perspective view of Figure 18 O expander.
Figure 18 Q show the side view of the expander for providing therapeutic agent to the Eustachian tube of patient.
Figure 18 R show the perspective view of Figure 18 Q expander.
Figure 18 S show to be arranged on the side for being used to provide the expander for the treatment of to the Eustachian tube of patient in the Eustachian tube of patient View.
Figure 18 T show the sectional view of the expander of Figure 18 S in the Eustachian tube of patient, and wherein expander is in expansion shape State.
Figure 18 U show to be arranged on the side for being used to provide the expander for the treatment of to the Eustachian tube of patient in the Eustachian tube of patient View, wherein expander are in its deflated state.
Figure 18 V show to be arranged on the side view of the expander of Figure 18 U in the Eustachian tube of patient, and wherein expander is in half Inflated condition.
Figure 18 W show to be arranged on the side view of the expander of Figure 18 U in the Eustachian tube of patient, and wherein expander has been in Full inflated condition.
Figure 18 X show the side view of the expander for providing treatment to the Eustachian tube of patient.
Figure 18 Y and Figure 18 Z are shown respectively by the Eustachian tube section view before and after treatment of Figure 18 X expander treatment Figure.
Figure 19 A and Figure 19 B show the side view of the support for providing treatment to the Eustachian tube of patient.
Figure 19 C and Figure 19 D show the support in the different expansion stages for providing treatment to the Eustachian tube of patient Side view.
Figure 20 A, Figure 20 B and Figure 20 C show the distal side end of the guiding catheter of the opening handing-over for the Eustachian tube with patient The sectional view at end.
Figure 21 A and Figure 21 B be shown respectively for patient Eustachian tube provide treatment oblong insert perspective view and Sectional view.
Figure 22 A show the side view of the filament insert for providing treatment to the Eustachian tube of patient.
Figure 22 B, Figure 22 C and Figure 22 D show the broken section of the delivery catheter of the filament insert for delivering Figure 22 A Figure.
Figure 22 E and Figure 22 F are shown in the filament for providing Figure 22 A used in the method for the treatment of to the Eustachian tube of patient The partial sectional view of insert.
Figure 23 A to Figure 23 C are that two the various of embodiment for entering guiding equipment with the Eustachian tube of endoscope coupling regard Figure.
Figure 24 A to Figure 24 C are regarded with two the various of embodiment of the Eustachian tube sacculus dilating catheter of endoscope coupling Figure.
Figure 25 is the side view for entering guiding piece according to the Eustachian tube of an embodiment.
Figure 26 is the side view according to the Eustachian tube sacculus dilating catheter of an embodiment.
Figure 27 is that the balloon expandable for entering guiding piece according to the Eustachian tube of an embodiment and being arranged in guiding piece is led The side view of pipe.
Figure 28 A to Figure 28 D are according to the foley's tube of an embodiment and to bend the foley's tube preformed Bend the side view of stylet.
Figure 29 A and Figure 29 B are the sides according to the extendible flexible foley's tube with guiding piece of an embodiment View.
Figure 30 shows the side front view of the suitable exemplary illuminating guidewire being used together with sacculus dilating catheter.
Figure 31 shows the sectional view of Figure 30 illuminating guidewire.
Figure 32 shows to be adapted to lead with the exemplary illumination that the sacculus dilating catheter with the distal end widened is used together The side front view of silk.
Figure 33 shows the sectional view of Figure 32 illuminating guidewire.
Embodiment
Embodiment of the present invention be related to for enter, diagnose and treat middle ear and Eustachian tube in target tissue region side Method and system.
Into
One embodiment of the invention is directed to use with minimal invasive techniques and enters middle ear through Eustachian tube to realize.In an implementation In scheme, middle ear space can be entered via Eustachian tube (ET).Enter eustachian orifice to realize, guiding catheter can be used, this draws Conduit has greater than about 30 degree and the bending section less than about 90 degree in its distal end.Once into, so that it may it will diagnose Or intervening equipment is introduced into Eustachian tube.Optionally, in order to prevent the middle ear structure to rapid wear from causing damage, safe machine can be used Structure.In one embodiment, release mechanism may include the probe and/or sensor being introduced into via eardrum in middle ear, such as Fig. 7 institutes Show.For example, probe can be endoscope, and sensor can be electromagnetic transducer.
Fig. 7 is the sectional view for showing guiding catheter 100 and nasopharyngeal area in nasal passage, wherein guiding catheter 100 Distal end 102 is adjacent to Eustachian tube opening.Fig. 7 is shown and the guiding catheter of eustachian orifice adjacent positioned 100, guiding catheter 100 There is greater than about 30 degree and the bending section less than about 90 degree in its distal end 102.With the sensor of eardrum adjacent positioned 104 can be used for the propulsion of monitoring guiding catheter 100.Sensor 104 is an example of release mechanism.
In various alternative embodiments, guiding catheter 100 can have any suitable length, diameter, angle of bend and The position of length of the bending section along conduit 100, in order to enter Eustachian tube opening.In some embodiments, for example, leading Pipe 100 can have between about 10cm and about 20cm, more preferably between the length between about 12cm and about 16cm.Various In embodiment, guiding catheter 100 can have a bending section, and the bending section has between about 0 degree and about between 180 degree, more excellent Angle of the selection of land between about 30 degree and about 90 degree.In one embodiment, for example, guiding catheter 100 can have length, Angle of bend and configured in one piece, so as to via the entrance in the nostril by the Eustachian tube with being entered on the phase homonymy on head come Into Eustachian tube.In an alternative embodiment, guiding catheter 100 can have length, angle of bend and configured in one piece, so as to Enter Eustachian tube via the entrance in the nostril by the Eustachian tube with being entered on the offside (opposite side) on head.This is latter The angle of bend of embodiment can for example be more than the angle of bend for being used for the guiding catheter 100 that phase homonymy enters.
In one embodiment, guiding catheter 100 can be ductility so that user will can guide during use Conduit 100 is bent to maintains the intended shape of its own at least in part.In another embodiment, guiding catheter 100 can It can turn to.For example, at least a portion of guiding catheter 100 can be partially flexible, and the part can by with conduit Draught line of steering mechanism one or more etc. of 100 proximal end coupling turns to.Various embodiments may include one It is individual can knuckle section or it is multiple can knuckle section.Various embodiments may also include it is any suitably can steering angle.For example, one It is individual can the flexible angle into about 30 degree of knuckle section, and another can the flexible angle into about 45 degree of knuckle section.Angle Degree and can any combinations of knuckle section may include in various embodiments.
In some embodiments, guiding catheter 100 can be combined with flexible or rigid endoscope or can with it is flexible or Rigid endoscope combines.In one embodiment, for example, soft endoscope can be built in the main body of guiding catheter 100. In another embodiment, guiding catheter 100 may include endoscope tube chamber, and soft endoscope can be pushed away by endoscope tube chamber Enter.In still another embodiment, guiding catheter may include the tube chamber, fixture or other attachments for being attached to rigid endoscope Component (or multiple components).For example, in some embodiments, guiding catheter 100 could attach to the rigidity of variable viewing angle Endoscope, such as swing prism endoscope.
Some embodiments of guiding catheter 100 may include the optional suction orifice in proximal end or near it, So that conduit 100 may be connected to vacuum/suction source.In these embodiments, guiding catheter 100 may include single suction tube Chamber, or alternatively, suction can be guided through the identical tube chamber that equipment extends there through.Some embodiments may include to be used to permit Perhaps equipment maintains the check valve of swabbing pressure through guiding catheter 100 simultaneously.
In use, guiding catheter 100 can be advanced in nostril and by nasal cavity, by the distal end portion of conduit 100 Portion is positioned at the opening into Eustachian tube, in opening or near opening.In one embodiment, guiding catheter 100 can be worn Cross Eustachian tube of the nostril to the homonymy (phase homonymy) on head.In an alternative embodiment, guiding catheter 100 may pass through Eustachian tube on nostril to the offside (opposite side) on head.Once being realized using guiding catheter 100 into Eustachian tube, then can make Any one in multiple codes is performed on Eustachian tube with any of a variety of distinct devices.Optionally, in some embodiment party In case, guiding catheter 100 can be used for pumping out blood from Eustachian tube and/or nasal cavity during and/or after the propulsion of conduit 100 And/or other fluid/materials.In the alternative embodiment being described more fully below, guiding catheter 100 can be disappeared from code Remove, and can be entered in the case of without using conduit 100 with one or more equipment and treat Eustachian tube.
Diagnosis
Another embodiment of the invention is related to the diagnosis of the illness and its structure of middle ear.In one embodiment, Diagnosis, which may include to use, to be advanced in appropriate location or is integrated into guiding catheter 100 by guiding catheter 100 Endoscope.The design of endoscope visualizes the Y-axis for allowing 90 degree or more and 360 degree rotate.This endoscope can be used for assessing Cholesteatoma, phonophore function and/or illness and surgical follow-up.The exemplary endoscopic that can be reequiped as described above can be used The 1.8mm cameras of IntroSpicio 115 developed by Medigus.The size of this camera is about 1.8mm × 1.8mm, and Its small rigid element allows the maximum flexibility in endoscope end.
Alternatively, can by inject fluid into middle ear space and ET and ultrasonic scanning middle ear and ET and its structure come Use ultrasonic wave.After code it is smokable go out or retain fluid to be discharged by Eustachian tube.The conduit of end band ultrasound can along ET to On be advanced to position at tympanum.Then ultrasound catheter can be pulled downward on along ET, and external video prison can be used in doctor Visual organ observes the structure that ET neutralizes neighbouring ET.
The functional diagnosis of Eustachian tube can be assessed to realize via direct or indirect.In one embodiment, in order to carry out Directly assess, diagnostic system can allow swallowing period dynamic monitoring Eustachian tube via diagnostic probe (it is inserted via nasopharynx). Because this diagnostic system can be dynamically used during swallow, hiding probe can be by being configured to the flexible and durable material of hurtless measure Material is made.In one embodiment, once diagnostic probe be located in ET regions or near, and before swallowing, Ke Yiyi Except (one or more) guiding catheter 100 close for nasopharynx.
In one embodiment, diagnostic probe may include endoscope to visualize ET 26S Proteasome Structure and Functions.Alternatively, diagnose Probe may include the pressure transducer on conduit or wire rod.When using pressure transducer, ET can be monitored during swallowing Interior pressure, and ET opening functions can be explained in pressure measuring value.Alternatively, ultrasonic probe can be inserted in ET tube chambers with scanning The structure in ET regions.It can introduce fluid into ET in order to Ultrasonic Diagnosis.For any one in above-mentioned diagnostic system, can be used The single short length transducer repositioned afterwards is being swallowed every time.Alternatively, transducer array can be used in order to mapping ET All or part of.
Above-mentioned technology can be used for the Eustachian tube for being directly entered and diagnosing patient.In one embodiment, suffer from for entering The method of the Eustachian tube of person may include that guiding catheter has distal end, should by the nasal passage of guiding catheter insertion patient Distal end has bending section, and wherein bending section has the angle between about 30 degree and about 90 degree；And in nasal passage In make guiding catheter towards the Eustachian tube in nasopharynx opening promote, by distal end adjacent to Eustachian tube opening place.In addition, This method may also include promotes diagnostic device to put the distal end of diagnostic device adjacent to Eustachian tube opening by guiding catheter Put.Diagnostic device may include diagnostic catheter.Diagnostic device may include endoscope, pressure transducer or ultrasound catheter.
Diagnostic probe is introduced into Eustachian tube in addition, this method may also include, directly to assess eustachian tube function.Preferably It is that diagnostic probe is made up of flexibility and the material compatible with Eustachian tube.Alternatively, diagnostic probe may include the pressure on seal wire Power transducer, and thus this method also includes monitoring the pressure in Eustachian tube when patient swallows；And commented using the monitoring Estimate the opening function of the Eustachian tube of patient.This method may additionally include diagnostic probe being placed into Eustachian tube removes guiding afterwards Conduit.In addition or alternatively, diagnostic probe may include ultrasonic probe.
Indirect functional diagnosis for Eustachian tube, in some embodiments, exterior source of energy can be used for assessing Eustachian tube Opening.For example, it may be possible to energy source may include but be not limited to pressure, sound, light or other electromagnetic energies.In indirect assessment In one embodiment, transmitter can be positioned in nasopharynx, and receiver can be placed at eardrum.By transmission signal and it can connect Correlation between the collection of letters number changes into the physical characteristic for swallowing period ET.
Above-mentioned technology can be used for realizing the code for entering and diagnosing the Eustachian tube of patient indirectly.Indirect assessment method is included in Locating energy transmitter in the nasopharynx of neighbouring European pipe；Via external auditory meatus adjacent to eardrum locating energy receiver；By energy from hair Emitter guides towards receiver；Generation represents the launcher signal of the energy from transmitter；Generation is represented by transmitter receipt Energy recipient signal；It is contrasted between launcher signal and receiver signal；And commented indirectly using the contrast Estimate the function of the Eustachian tube during swallowing.Energy emitter can be the emitted energy in the form of pressure wave or electromagnetic energy Equipment.Indirect assessment may also include the physical characteristic of estimation Eustachian tube.
Treatment
Another embodiment of the invention is related to the treatment of Eustachian tube obstacle.In some cases, for example, Eustachian tube hinders Hindering can be relevant with the structure obstruction of Eustachian tube.The structural obstacle of Eustachian tube is often as in anatomical structure exception or Eustachian tube Or the excessive or edematous tissue of surrounding, as shown in Figure 8.Fig. 8 shows the section of the anatomic region around Eustachian tube ET.Fig. 8 is shown Including eardrum TM, arteria carotis, ET cartilages some common anatomic landmarks, and the position of tensor veli palatini and levator muscle of palatine velum.Fig. 9 Diagnosis or the treatment protocol for showing to perform in the region around ET to Figure 10.
Fig. 9 shows the section of the anatomic region around Eustachian tube, its show around ET cut off edematous tissue diagnosis or Treatment protocol.Code shown in Fig. 9 enters ET tube chambers including the use of seal wire 202 and uses a sidesway of the resecting tool 204 from ET Except tissue.As shown in figure 9, in one embodiment, resecting tool 204 can have the excision end that bounces back protruded from side 206 so that end removes tissue from the side of ET tube chambers.The treatment protocol preferably allows for controllably entering and being positioned in ET And prevent the injury to apparent surface.It should be recognized that can be by ultrasonic guidance or visualization, such as by using can in ET Above-mentioned treatment protocol is performed depending on changing conduit.The diagnosis that ultrasound can be used for before treatment as described above.It can also be used for controlling Guide and/or aid in during treatment.In alternative embodiment, resecting tool 204 can in the case of without using seal wire quilt It is advanced in Eustachian tube, and can be pushed into the case of use or without using guiding catheter.
Figure 10 shows the section of the anatomic region around Eustachian tube, and it shows that the alternative of edematous tissue is cut off around ET to be controlled Treat code.In the alternative code shown in Figure 10, excision equipment 304 can draw at its end or distal end 306 under mucous membrane Enter between cartilage 330 and mucomembranous surface, so as to protect mucomembranous surface.Code, seal wire 302 and/or excision equipment are selected else for this It can pass through between tube chamber and cartilage, so as to protect both mucomembranous surface and arteria carotis.As shown in Figure 10, seal wire 302 can be viscous It is inserted under film at inlet point between ET cartilages and mucomembranous surface.Then, resecting tool 304 can be introduced into along seal wire 302, to cut Except tissue regions are without influenceing mucomembranous surface.Ultrasound may be used as resecting tool such as low-power, efficient ultrasound, to melt, Shrink or cut off the tissue under mucosal tissue.As previously described equipment, in alternative embodiment, excision equipment 304 Can be advanced in the case of without using seal wire in Eustachian tube, and can using or without using guiding catheter in the case of quilt Promote.
Above-mentioned treatment technology can be used for the Eustachian tube that patient is treated by following steps：Seal wire is put via the nasopharynx of patient Put in the Eustachian tube of patient；Excision equipment is introduced into the Eustachian tube of patient along seal wire；And from the side along Eustachian tube Surface removes the edematous tissue for including hypertrophica mucous membrane.Seal wire may include for providing the feedback related in Eustachian tube to being introduced into Mark.Alternatively, resecting tool can be introduced into ET, and without placing seal wire wherein first.In either case (that is, using or without using seal wire), in some embodiments, therapeutic equipment can be advanced to Eustachian tube via guiding catheter In, and in alternative embodiment, therapeutic equipment can be pushed into the case of without using guiding catheter.In fact, in equipment Various alternative embodiments in, in therapeutic equipment as described herein any one can using or without using seal wire and use Or without using guiding catheter in the case of use.
Alternatively, the method for the Eustachian tube for treating patient's body may include：Will under mucous membrane via the nasopharynx of patient Seal wire is introduced between the cartilage and mucomembranous surface of Eustachian tube；Along seal wire by excision equipment introducing Eustachian tube in cartilage and mucous membrane table In submucous tissue between face；And remove some submucous tissues.
Except mechanotherapy, laser therapy described in above-mentioned Fig. 9 to Figure 10 and in addition to shown treatment protocol, can be used, penetrate Frequency treatment and/or chemotherapy are removed or remolded (such as contraction) to realize tissue.For example, in muscle dysfunction or anatomical In the case that obstacle is as influence factor, it can shorten or stretch muscle (tensor veli palatini or levator muscle of palatine velum).Realize or shorten muscle A kind of method be in muscle formed ablation stove.Over time, ablation stove is absorbed, and muscle is due to reabsorption Muscle quality and tightened up in a manner of similar to Somnoplasty.
Another embodiment of the invention is related to the treatment of the Eustachian tube obstacle as caused by inflammation or oedema.Except above-mentioned Outside surgical protocols, also oedema can be reduced by drug therapy.It can help control locally using serial of methods Treat agent particularly steroids to be delivered in ET mucous membranes, these methods are micro- including the use of the nasopharynx or middle ear side for being designed to enter ET Conduit is directly drawn into ET.Alternatively, can be from the surface delivery of agents of dilating sacculus.In the case, can be by reagent deposition Into mucous layer rather than deposit on its surface.By being embedded into mucous membrane by drug deposition into reservoir and by reservoir In can be advantageous to sustained release delivery.It is viscous by being attached to including the reagent as particle and by particle loading reservoir particle Film surface, the extension of therapeutic agent residence time can be achieved.Alternatively, the residence time of therapeutic agent can be by the way that reservoir be implanted to Controlled in ET or its minor structure.
According to the illustrative drug delivery system of an embodiment figure 11 illustrates.As shown in figure 11, pressure is balanced Pipe 400 can be inserted into eardrum.Pressure equalization tube includes residing in the extension 402 in the region of Eustachian tube, and wherein extension has There are drug delivery capabilities.As shown in figure 11, pressure equalization tube 400 can be double lumen, to provide medicine delivery and ventilatory function.Tool The pressure equalization tube 400 for having extension 402 may be designed to slide between eardrum TM radiating fibers.When in appropriate location When, pipe can be oriented to minimize migration path.
Alternatively, as shown in figure 12, drug delivery system can be provided by nasopharynx.As shown in figure 12, medicine delivery can be from Temporary implant 500 provides in tube chamber.The occasional nature of implant 500 can need removal system, or can by degraded and/or Digestion removes to provide nature.Similar to above-mentioned excision equipment, drug delivery system can be also implanted under mucous membrane, therefore be had Without prejudice to the benefit of surface mucosa.In one embodiment, implant can be deployed to the rear pad between ET tube chamber and cartilage In.This method can be benefited from using consistent anatomic landmark, and can be minimized to middle ear or the traumatogenic possibility of arteria carotis Property.Implant 500 may include the medicine delivery reservoir of the anchoring of coil form, and the coil is with distally 502 to nearside 504 The diameter being gradually reduced.
Figure 13 shows the section of the anatomic region around Eustachian tube ET, and it shows setting for the pharynx mouth by being inserted through Eustachian tube The standby diagnosis performed or treatment protocol.Figure 13 shows the seal wire GW inserted by nasopharynx in the desired region in ET, and passes through The diagnosis or treatment protocol that the equipment being introduced on seal wire GW in Eustachian tube performs.
Figure 13 A show the zoomed-in view of the region 33A in Figure 13, and it shows the anatomic region around Eustachian tube ET, and Diagnosis or the treatment protocol of the equipment execution of pharynx mouth by being inserted through Eustachian tube are shown.In one embodiment, seal wire GW Including the anchoring sacculus 3200 on seal wire GW distal region.After seal wire GW is positioned at into target location, make anchor Gu sacculus 3200 inflates.Anchoring sacculus 3200 anchors to seal wire GW neighbouring anatomical structure, and prevents from diagnosing or treating rule Seal wire GW is surprisingly repositioned during journey.Anchoring sacculus 3200 can be made up of any suitable compliance or semi-compliant material, Polyethylene or other polyolefin, polyurethane, flexible polyvinyl chloride, nylon for being such as, but not limited to crosslinked etc..In various alternative realities Apply in scheme, seal wire GW may include one or more anchoring elements in addition to sacculus 3200 is anchored, such as recessed on seal wire GW Mouth, the bending area on seal wire GW, self-expanding element, hook, coiling element etc..In another embodiment, seal wire GW can be wrapped Include the sensor 3202 on seal wire GW distal region.Sensor 3202 may be such that seal wire GW can be led with suitable surgery Boat system is used in combination.In one embodiment, sensor 3202 may include and electromagnetism surgical navigation system such as GE The electromagnetic sensor that InstaTrakTM3 500plus systems are used in combination.One or more sensors 3202 or other types of Surgical navigation sensor or transmitter may be alternatively located on other diagnosis disclosed herein or therapeutic equipment.Sensor 3202 can be with position Fixation sensor 3204 in external ear is used in combination.The combination of sensor 3202 and fixed sensor 3204 can be advantageous to lead Silk GW positioning is in the target area.
In some embodiments, seal wire GW can its distal end, its proximal end or the two at include one or more Individual stopper element (not shown).Such stopper element can be the supplement of anchoring sacculus 3200, or may include without anchoring In the embodiment of sacculus 3200.Stopper element helps prevent seal wire GW distal end too remote into Eustachian tube, so as to help Prevent due to promoting the too remote inducible any infringements to structure of seal wire GW.In one embodiment, for example, seal wire GW can Including preventing its distal curvature or bending section through the narrow of Eustachian tube.The embodiment or another embodiment are also It may include the nearside stopper element of the portions of proximal of the guiding catheter extended there through against seal wire, so as to prevent seal wire through too Far.In in the above-described embodiment any one, seal wire can also have hurtless measure end.
In another embodiment, the impermeable plug 3206 of ray can insert the region of neighbouring eardrum from external ear.Ray Impermeable plug 3206 can be used as reference mark during the preoperative scanning of patient, and therefore may be such that doctor will can diagnose Or therapeutic equipment positions close to eardrum exactly.Other image bootstrap techniques and equipment also can be with diagnosis disclosed herein or treatments Code is used in combination.Figure 13 A also illustrate diagnosis or therapeutic equipment 3208 including axle 3210 and operation element 3212, operation element 3212 dilating sacculus being for example introduced on seal wire GW.Diagnosis or therapeutic equipment 3208 may include the impermeable mark of ray 3214。
Figure 13 B show the front view of head part, and a part for its septum reset is removed to show seal wire GW introducing pharynx drum The embodiment of method in pipe.In Figure 13 B, guiding catheter 3250 is introduced into nasopharynx by nostril.Guiding catheter 3250 The distal part region that may include to bend or be at an angle of.For example, in one embodiment, this bending or angled region Interior angle in the range of being formed from about 45 degree to about 150 degree.It may be used at the co-pending patent application sequence number of assignee One kind in various designs disclosed in 11/926,565 (attorney 83529.0066) constructs guiding catheter 3250, This application is herein incorporated by reference.Guiding catheter 3250 is positioned in nasopharynx so that the distal end of guiding catheter 3250 Near the nasopharynx opening of Eustachian tube.Hereafter, seal wire GW is introduced into Eustachian tube by guiding catheter 3250.Then, seal wire GW can be used for one or more diagnosis or therapeutic equipment being advanced in Eustachian tube to perform one or more diagnosis or treatment rule Journey.
Figure 14 A to Figure 14 D show the various realities that can be located at the operation element of diagnosis or therapeutic equipment such as on conduit 3210 Scheme is applied, the operation element can be pushed on seal wire 3208 in some embodiments.Figure 14 A are shown with operation element Sacculus dilating catheter 3210, it is included in the dilating sacculus 3312 being pushed on seal wire 3208.Dilating sacculus 3312 can be by Suitable non-compliance material such as, but not limited to polyethylene terephthalate, nylon etc. is made.In various alternative implementations In scheme, foley's tube 3210 can be pushed into the case of without using guiding catheter on seal wire 3208, without using leading It is pushed into the case of silk 3208 on guiding catheter or by guiding catheter, on seal wire 3208 and by leading Pipe is pushed into, or in the case of without using seal wire 3208 or guiding catheter by self-propelled (such as in the rigid sacculus in part In the case of conduit).In addition, in various embodiments, foley's tube 3210 may include the inflation for sacculus 3312/let out Put, rinse and/or aspirate, medicine delivery, make multiple tube chambers or its any conjunction that visualization device such as soft endoscope passes through Suitable combination.
Figure 14 B show to include the example of the operation element for the dilating sacculus 3314 for being mounted with balloon expandable stent 3316. In some embodiments, dilating sacculus 3314 can be by suitable non-compliance material such as, but not limited to poly terephthalic acid second Diol ester, nylon etc. are made.If the support Design of dry type can be used to construct support 3316, such as, but not limited to metal tube is set Meter, polymerization pipe design, chain type design, helical design, rolled sheet metal design, one wire design etc..These design can have perforate or Hole-closing structure.A variety of manufacture methods can be used for manufacture support 3316, including but not limited to laser cut metal or polymer element, Welding metal element etc..Multiple material can be used for manufacture support 3316, including but not limited to metal, polymer, foam class material, It is plastically deformed material, elastic material etc..Various features can be added to support 3316, including but not limited to ray is impermeable Coating, the medicament elution mechanism for eluting antiinflammatory, antibiotic etc..In one embodiment, support 3316 can be biology It is absorbable.Operation element may also include self-expanding stent rather than pressure expandable support.
Figure 14 C show the alternative embodiment for including lavage catheter 3210, and wherein operation element includes lavation element 3318. Lavation element 3318 may include multiple lavation openings 3320.The irrigating tube that lavation opening 3320 may be connected in the axle of conduit 3210 Chamber, the suitable lavation medium of such as the following can be delivered by lavation tube chamber：Solution containing contrast agent, pharmaceutically may be used The formulation of the salt or antimicrobial (for example, antibiotic, antiviral drugs, anti-parasite medicine, antifungal agent etc.) of receiving, tool Have or without vasoconstrictor anesthetic (for example, with or without adrenergic lidocaine, with or without Adrenergic totokaine etc.), anodyne, corticosteroid or other anti-inflammatory agents (for example, NSAID), decongestant (for example, Vasoconstrictor), mucus diluent (for example, expectorant or mucolytic agent), prevention or modification allergic response reagent (example Such as, antihistaminic, cell factor inhibitors, leukotriene inhibitors, IgE inhibitor, immunomodulator), allergen or another kind Cause the material, styptic, anti-proliferative agent, cytotoxic agent (for example, alcohol) for hemostasis, biology system of tissue mucous secretion Agent (protein molecule, stem cell, gene or gene therapy formulation) etc..In one embodiment, lavation opening 3320 A part may be connected to suction lumen, lavation medium is pumped out from Eustachian tube.
Figure 14 D show the example for including the operation element of material delivering reservoir 3322.Material delivering reservoir 3322 can For completely or partially it is biodegradable or not biodegradable.In one embodiment, material delivering reservoir 3322 It is made up of suitable biocompatible materials such as hydrogel (such as collagen hydrogel).In another embodiment, material Delivering reservoir 3322 includes the porous matrix formed by porous material, such as flexible or rigid foam of polymers, cotton-wool, gauze Deng.The example of porous biodegradable polymers can be become with foamed or otherwise includes PGA, poly- left-handed Lactide, poly- dextrorotation lactide, poly- (amino acid), PPDO, polycaprolactone, polyglyconate, PLA-polyoxy Change ethylene copolymer, modified cellulose, collagen, poe, poly(hydrobutyl ester), polyanhydride, polyphosphate, poly- ('alpha '-hydroxy acids) with And combinations thereof.Foamed or it can otherwise become the examples of porous non-biodegradable polymers and include poly- ammonia Ester, makrolon, elastomer silicone etc..Material delivering reservoir 3322 may also include in the title submitted on the 4th of August in 2004 For " Implantable Device and Methods for Delivering Drugs and Other Substances Disclosed in Treat Sinusitis and Other Disorders " U.S. Patent Application Serial Number 10/912,578 One or more embodiments, the complete disclosure of this application are clearly herein incorporated by reference.Material delivering storage Any material delivery device described in device 3322 or this application can be used for delivering various types of therapeutic agents or diagnosticum.Such as this Term " diagnosis or therapeutic substance " used in text is from being broadly interpreted as including any feasible medicine, prodrug, protein, gene Treat preparation, cell, diagnosticum, contrast agent or developer, biological agent etc..Such material can be combination or free form, liquid Body or solid, colloid or other suspension, solution, or can be gas or other fluids or nonfluid form.For example, at some In the application for it is expected to treat or prevent microorganism infection, the material of delivering may include following reagent pharmaceutically acceptable salt or Formulation：Antimicrobial (such as antibiotic, antivirotic, antiparasitic, antifungal agent etc.), corticosteroid or other anti- Scorching agent (such as NSAID), decongestant (such as vasoconstrictor), mucus diluent (such as expectorant or mucolytic), The reagent of suppression or modification allergic response (such as antihistaminic, cell factor inhibitors, leukotriene inhibitors, IgE suppress Agent) etc..
Some non-limiting examples for the antimicrobial that can be used in the present invention include：ACV, amantadine, Aminoglycosides (such as amikacin, gentamicin and TOB), Amoxicillin, amoxicillin-clavulantes, both sexes Mycin B, ampicillin, ampicillin Sulbactam, Atovaquone, azithromycin, cephazoline, Cefepime, cephalo thiophene Oxime, cefotetan, Cefpodoxime, cefotaxime, Ceftizoxime, ceftriaxone, cefuroxime, CEFUROXIME AXETIL, cefalexin, Chloramphenicol, clotrimazole, Ciprofloxacin, CLA, clindamycin, dapsone, dicloxacillin, fortimicin, erythromycin, fluorine Health azoles, FOSCARNET, GCV, gatifloxacin, imipenem cilastatin, isoniazid, Itraconazole, ketoconazole, metronidazole, Naphthlazole, naphthlazole, nystatin, penicillin, benzyl penicillin, pentamidine, piperazine La Xita shores, rifampin, Quinupristin- Dalfopristin, Ticarcillin Clavulanate, trimethoprim Sulfamethoxazole, Valaciclovir, vancomycin, sulfanilamide (SN) Myron, flamazine, mupirocin are (for example, U.S. north Caro Rana state triangle research Ge Lanshi Su Ke company (Glaxo SmithKline), Mupirocin Ointment), nystatin, Triamcinolone acetonide inhibin (triarncinolonelnystatin), clotrimazole times Ta meter Song, clotrimazole, ketoconazole, butoconazole, Miconazole, tioconazole；Interference or the detergent class chemicals for killing microorganism (such as Nonoxynol-9, octoxynol 9, benzalkonium chloride, menphegol and n-docosanol)；Prevent microorganism adhering in The chemicals of target cell and/or suppression infectious disease pathogens entrance (such as sulfate and sulfonate polymer, such as PC-515 (carrageenan), Pro-2000 and dextrin 2- sulfate)；Suppress the antiretroviral agent that retrovirus replicates in the cell (such as PMPA gels)；Through genetic engineering transformation or it is naturally occurring support antiviral antibody (such as from plant obtain through The antiviral antibody of genetic engineering transformation, is referred to as " plantibody ")；Changing organizational environment makes it be unfavorable for the reagent of pathogen (material (such as Buffer Gel and Acidform) for such as changing mucous membrane pH)；Hydrogen peroxide or other killings or suppression can be produced Non- pathogenic or " beneficial " microorganism (such as Bacillus acidi lactici) of the material of pathogenic microorganisms growth processed；Antimicrobial proteins are anti-micro- (those such as described in United States Patent (USP) 6,716,813 (Lin et al.), the disclosure of which is with the side of reference for biological peptide Formula is clearly incorporated herein) or antimicrobial metal (such as collargol).
In addition or alternatively, in some need to treat or prevent the application of inflammation, delivered in the present invention Material can include various steroids or other antiinflammatories (such as non-steroidal anti-inflammatory agent or NSAID), anodyne or antipyretic.Example Such as, can be used it is foregoing it is intranasal 10 administration apply corticosteroids, such as beclomethasone (Vancenase.RTM. or Beconase), flunisolide (Nasalid.RTM.), FLUTICASONE PROPIONATE (Flonase.RTM.), Triamcinolone acetonide (Nasacort.RTM.), budesonide (Rhinocort Aqua.RTM.), Lotepredenol etabonate (Locort) and not rice Loose (Nasonex.RTM.).Other salt forms of above-mentioned corticosteroid can also be used.In addition, the class that can be used in the present invention Other non-limiting examples of sterol include but is not limited to：Alclometasone, desonide, hydrocortisone, betamethasone, chlorine can be held in the palm Dragon, Desoximetasone, FA, fludroxycortide, Mometasone, prednicarbate, Amcinonide, Desoximetasone, diflorasone, fluorine are light Pine, fluocinonide, Halcinonide, clobetasol, enhanced betamethasone, diflorasone, halogen Beta rope, metacortandracin, Sai meter Song and methylprednisolone.Available other antiinflammatories, anodyne or antipyretic include：Non-selective COX inhibitor (such as water Poplar acid derivative, aspirin, sodium salicylate, choline magnesium trisalicylate, salsalate, diflunisal, Salazosulfamide pyrrole Pyridine and Olsalazine；P-aminophenol derivatives (such as paracetamol)；Indoles and indeneacetic acid (such as indocin and Shu Lin Acid)；Heteroaryl acetic acid (such as tolmetin, Diclofenac and ketorolac)；(such as brufen, naproxen, fluorine compare Lip river to arylpropionic acid Sweet smell, Ketoprofen, fenoprofen He Oxaprozin)；Ortho-aminobenzoic acid (that fragrant ester) (such as mefenamic acid and Meloxicam)；Enol Sour (such as former times health class (piroxicam, Meloxicam)) and alkanone (such as Nabumetone)) and Selective COX-2 inhibitor (such as the furanone (such as rofecoxib) of diaryl substitution；The pyrazoles (such as celecoxib) of diaryl substitution；Heteroauxin (such as Etodolac) and aniline sulfonic acid (such as aulin)).
In addition or alternatively, some using it is all if desired for treat or prevent allergia response or immune response and/ Or in those applications of cell propagation, the material delivered in the present invention may include：A) various cell factor inhibitors, such as Humanized's anti-cytokine antibodies, cytokine receptors antibody, restructuring (neoblast caused by genetic recombination) antagonist or can Dissolubility acceptor；B) various leukotriene modifers, such as zafirlukast, montelukast and Zileuton；C) immunoglobulin (IgE) presses down Preparation, such as Ao Mazuo monoclonal antibodies (anti-IgE Mab, being referred to as rhu Mab-E25 in the past) and secretory Leucoprotease Inhibitor；And d) SYK kinase inhibitors, such as by Lek Pharmaceuticals D. D. (Rigel of California South San Francisco Pharmaceuticals) the reagent for being referred to as " R-112 " of manufacture.
In addition or alternatively, stop at some using all if desired for contraction mucosal tissue, the congested situation of mitigation or realization In those applications of blood, the material that is delivered in the present invention may include for the various of decongestant and/or styptic purpose Vasoconstrictor, including but not limited to pseudoephedrine, xylometazoline, oxymetazoline, neo-synephrine, adrenaline etc..
In addition or alternatively, in some applications such as need those applications flowed beneficial to mucus, in this hair Bright middle delivered material can include regulation mucus or the viscosity of mucoid secretion or the various mucolytics of denseness Or other reagents, including but not limited to acetylcysteine.In a specific embodiment, the thing delivered in the present invention Matter may include the combination of antiinflammatory (such as steroids or NSAID) and mucolytic agent.
In addition or alternatively, some using it is all if desired for prevent or prevent histamine release those applications in, The material delivered in the present invention may include various mast cell stabilizers or prevent the medicine of histamine release, such as Cromoglycic acid (such as Nasal Chrom) and nedocromil.
In addition or alternatively, in some apply all those applications acted on if desired for prevention or suppression histamine, The material delivered in the present invention can include various antihistaminics, such as azelastine (such as Astylin), diphenhydramine, Loratadine etc..
In addition or alternatively, it is all if desired for dissolving, degrade, cut, fracture or remold bone in some embodiments Or in those embodiments of cartilage, the material delivered in the present invention may include to weaken or repair bone and/or cartilage with Be advantageous to the present invention wherein bone or cartilage remolded, shaping, the material for the other codes for fractureing or removing.Such reagent One example can be calcium chelating agent, such as EDTA, and its material being injected into close to the bony areas waited to remold or repaired is passed Send in implant or delivered with the substance delivering implant.Another example can be made up of or contain bone bone degradation of cell The preparation of bone degradation of cell, the bone degradation of cell such as osteoclast.Other examples may include to soften or decompose bone Or the various enzyme materials of components of cartilage, such as clostridiopetidase A (CGN), trypsase, trypsase 1EDTA, hyaluronidase, He Jia Benzenesulfonyl lysyl chloromethanes (TLCM).
In addition or alternatively, in some applications, the material delivered in the present invention may include the use of other species In the material for the treatment of rhinitis, nasal polyp, nasal cavity inflammation and other ear nose larynx obstacles, include but is not limited to tend to dry nasal secretions The anticholinergic drug of thing, such as ipratropium (Atrovent Nasal.RTM.), and other reagents unlisted herein.
In addition or alternatively, answered at some using all if desired for from those of polyp or edematous tissue draw fluid In, the material delivered in the present invention may include local action diuretics, such as furosemide and/or high osmotic agent, such as can be from group The sodium chloride gel to absorb water or other salt prefs are knitted, or can directly or indirectly change mucus osmotic content so that more juicy Tissue is discharged so that the material that polyp shrinks directly at its site.
In addition or alternatively, in some apply all those applications if desired for treatment tumour or cancerous lesion, The material delivered in the present invention may include antitumor agent (for example, cancer chemotherapy medicine, BRM, vascularization suppression Preparation, hormone receptor blocking agent, low temperature therapy medicine or other destructions or suppression neoplasia or tumorigenic reagent)；Such as alkane Base agent or it is other by attack reagent (for example, endoxan, ifosfamide) that cancer cell DNA directly kills cancer cell, Nitroso ureas or other reagents by suppressing the required change kill cancer cell of cell DNA reparation are (for example, BCNU (BCNU) and lomustine (CCNU)), antimetabolite and other by disturbing specific cells function (be usually DNA synthesis) to prevent The reagent (for example, 6-MP and 5 FU 5 fluorouracil (5FU)) of growth of cancer cells, antitumor antibiotics and it is other by combining or Insertion DNA and suppress RNA synthesis play a role compound (for example, Doxorubicin, daunorubicin, epirubicin, she reach than Star, Mitomycin-C and bleomycin), plant (catharanthus roseus) alkaloid and other antitumor agents from plant be (for example, Changchun New alkali and vincaleukoblastinum), steroid hormone, hormone inhibitors, hormone receptor antagonists and other influence hormone response cancer growths Reagent (for example, TAM, Trastuzumab, aromatase inhibitor such as aminoglutethimide and formestane, all Tathagata of triazole inhibitor Bent azoles and Anastrozole, steroid inhibitors such as Exemestane), anti-angiogenic proteins, small molecule, gene therapy and/or Other reagents (for example, meth-1, meth-2, thalidomide) for suppressing Tumor Angiongesis or vascularization, bevacizumab (Ah Gas spit of fland), squalamine, Endostatin, angiostatin, Angiozyme, AE-941 (Neovastat (Neovastat)), CC- 5013 (Revlimids), medi-522 (Vitaxin), 2ME2 (2ME2, Panzem), CAI (CAI), examine Cloth statin A4 prodrugs (CA4P), SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11,1M862, TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon-' alpha ', IL-12 (IL-12) or《Science》The Volume 289, (it is explicitly by being incorporated by this for any compound of mark in the 1197-1201 pages (on August 17th, 2000) Text), BRM (for example, interferon, BCG vaccine (BCG), monoclonal antibody, interleukin-22, granular leukocyte colony stimulate Factor (GCSF) etc.), PGDF receptor antagonists, Trastuzumab, asparaginase, busulfan, carboplatin, cis-platinum, BCNU, chlorobenzene Barbital, cytarabine, Dacarbazine, Etoposide, fluorine carbonohydrazides (flucarbazine), fluorouracil, gemcitabine, hydroxyl Base urea, ifosfamide, Irinotecan, lomustine, melphalan, mercaptopurine, methotrexate (MTX), thioguanine, phosphinothioylidynetrisaziridine, thunder replace Qu Sai, TPT, treosulfan, vincaleukoblastinum, vincristine, mitoazitrone, oxaliplatin, procarbazine, streptostacin, Taxol, taxotere, the analogs and derivatives of these compounds and other antitumor agents unlisted herein.
In addition or alternatively, at some using all those applications if desired for growth neoblast or the existing cell of modification In, the material that is delivered in the present invention can include cell (mucomembranous cell, fibroblast, stem cell or through genetic engineering The cell of transformation) and gene and gene delivery vector plasmid, adenovirus vector or naked DNA, mRNA etc., it is together with coding The gene of anti-inflammatory substance etc. injects together, and if desired, it is as mentioned above to repair or soften the osteoclastic thin of bone Born of the same parents, participation influence cell of mucus generation or cilium etc..
In addition to being combined with the modality of equipment and/or h substance or alternatively, it is generally desirable to Equipment is positioned in the ad-hoc location (i.e. sinus frontalis or sieve sinus) of mucus flowing path upstream.This can allow to deposit less medicine Thing release device, and all downstream tissues are permitted with desired medicine " shower ".Using mucus as the carrier for medicine This utilization can be preferable, especially because the concentration of medicine can be highest in the region for retaining mucus；And with good The non-lesion region of good mucus mobility will be less subject to the influence of medicine.This is in chronic nasosinusitis or tumour (wherein so that medicine Thing concentration is higher at these specific sites to have bigger treatment benefit) in can be particularly useful.In all such feelings In condition, local delivery has much smaller systemic effects by these medicines are permitted.It is furthermore desirable that configuration medicine composition or Delivery system so that it maintains the loose affinity with mucus, is evenly distributed in so as to permit it in stream.In addition, at some In, alternatives to medication, solute such as salt or other mucus soluble materials can be positioned at some opening position, thus make mucus Contact the material and a certain amount of material will dissolve in mucus, (such as pH, ooze appearance together so as to change some properties of mucus Rub).In some cases, the technology can be used for making mucus become hypertonic so that the mucus of flowing will be from polyp, oedema mucous membrane Extract water and/or other fluids such as tissue, so as to provide the therapeutic effect dried or be dehydrated.
The above-mentioned treatment of the Eustachian tube of patient allows therapeutic equipment to pass through guiding catheter towards Eustachian tube propulsion, will treatment The distal end of equipment is placed adjacent to Eustachian tube opening.Therapeutic equipment preferably has the impermeable distal member of ray.Treatment Equipment may include conduit.
Alternatively or in addition, therapeutic equipment can include the stream for being used to introduce fluid into the middle ear space of the ear of patient Body introduces equipment.Fluid can be air, contrast agent, suction fluid, or medicine such as the above.Treatment method can also wrap Include using ultrasonic device scanning middle ear space.Alternatively or in addition, therapeutic equipment can include being used for from middle ear space aspirate The pumping equipment of matter.
Alternatively or in addition, treatment may additionally include Eustachian tube nearside and introduce protection equipment, and be set using protection The propulsion of standby monitoring treatment equipment.Protection equipment can be to be positioned at the sensor of eardrum nearside, be treated with being sensed during propulsion The position of equipment.Alternatively, protection equipment may include endoscope to visualize propulsion.
Alternatively, or in addition, the method for the Eustachian tube for treating patient's body includes two-tube cavity pressure is balanced Pipe is placed by the eardrum of patient, and the pipe has the distal side extension for being used for being positioned in the region of Eustachian tube；By with distal side First tube chamber of the two-tube lumen that extension is in fluid communication provides medicine to the region of Eustachian tube；And pass through two-tube lumen Two tube chambers provide the ventilation across eardrum.Medicine is used for the oedema for reducing Eustachian tube region.
Medicine can also include surfactant, and it is configured to the surface tension for changing the mucous layer of Eustachian tube, to realize The wetting of enhancing of the medicine to mucomembranous surface.Medicine may also include the particle for the mucosal tissue capture by Eustachian tube, with Realize the sustained release of medicine.Exemplary surfactants are in entitled " Composition and Method for Treatment Of Otitis Media " United States Patent (USP) 6, disclosed in 616,913, the disclosure of which is herein incorporated by reference.
In another embodiment, the present invention relates to the device of the Eustachian tube for treating patient's body.The device bag Include the two-tube lumen in the eardrum of the ear for inserting patient.The pipe can include remote in the region of Eustachian tube for being placed on Side extension, the first tube chamber for providing medicine to the region of Eustachian tube by distal side extension, and for providing leap Second tube chamber of the ventilation of eardrum.
First tube chamber may be provided in the second tube chamber.Alternatively, the second tube chamber is arranged in the first tube chamber.In addition or Alternatively, the first tube chamber is set adjacent to the second tube chamber.Two-tube lumen can be made up of biodegradable bioabsorbable material, or The material can be included.
In another embodiment, the present invention relates to treat Eustachian tube by delivering drugs into Eustachian tube.The party Method enters Eustachian tube region including the use of the guiding piece with tube chamber via nasopharynx；Seal wire is introduced by the tube chamber of guiding piece, So that it is positioned between the cartilage of Eustachian tube and mucomembranous surface under mucous membrane；Make the interim tube chamber with medicine delivery reservoir Implant passes through along seal wire, rear pad implant being positioned under mucous membrane between the tube chamber and cartilage in Eustachian tube region In；And deliver the medicament to Eustachian tube region from medicine delivery reservoir.
In addition, this method may also include medicine from medicine delivery reservoir while be delivered to proventriculus type and Eustachian tube area Domain.In one embodiment, medicine delivery reservoir can include setting coating over the implant.In another embodiment party In case, guiding piece includes biodegradable bioabsorbable material.
In another embodiment, the treatment of the Eustachian tube of patient's body, which includes realizing via nasopharynx, enters Eustachian tube area Domain；It is introduced into via the nasopharynx of patient and is dimensioned to stretch into hollow seal wire in Eustachian tube region, hollow seal wire includes setting Multiple holes at or near its distal end；And the Eustachian tube or middle ear of the ear of patient are delivered drugs into by hole It is at least one in region.
In another embodiment, medicine can be via the tissue in iontophoresis delivery to Eustachian tube.In the reality Apply in scheme, medicinal fluid can be delivered in Eustachian tube, and can apply electric current to the fluid to drive the ion of medicine to pass through Tissue, such as mucous membrane or eardrum.
In another embodiment, the present invention relates to the system of the Eustachian tube for entering patient.The system can wrap Include guiding piece, its be arranged in the nasal passage into patient with by the distal end of conduit be positioned at Eustachian tube or its Near, the guiding piece has distal end, and distal end has bending section, and bending section has the angle between 30 degree and 90 degree Degree；And seal wire, it is configured to enter Eustachian tube through guiding piece.
In one embodiment, guiding piece includes conduit.In another embodiment, guiding piece includes double lumen Pipe.In another embodiment, system may also include the diagnostic device being arranged to through guiding piece.In another implementation In scheme, system may also include the therapeutic equipment being arranged to through guiding piece.
Non- seal wire equipment
Figure 15 A show the equipment 1500 for being used to treat Eustachian tube according to an embodiment.Equipment 1500 includes elongated Stiff shaft 1502.Stiff shaft can be made up of semi-flexible metal or plastics.Mean to incite somebody to action on " rigidity " that equipment 1500 uses When axle 1502 is inserted in nasal cavity, axle 1502 will be indeformable.Stiff shaft 1502 can be formed by ductile material and is customized to curved Song is for the field.Therapeutic equipment is couple to the distal part of stiff shaft 1502, and the therapeutic equipment is elongated in this example Flexible insert 1504.Retainer, which can be placed in the junction surface of 1504/ axle of insert 1502, which to be sentenced, prevents axle from entering Eustachian tube.Insert Enter part 1504 and preferably include lateral rigidity so that when inserting in Eustachian tube, insert 1504 will conform to the road of Eustachian tube Footpath, and do not cause the notable deformation of Eustachian tube.Insert 1504 may also include preformed shape (not shown), such as its quilt It is pre-formed into the anatomical structure of Eustachian tube.Insert 1504 preferably includes sufficiently strong column stiffness, to be inserted into Eustachian tube In collapsed without itself or warpage.The example of insert 1504 includes cored wire 1506 and balloon-expandable 1508.Cored wire 1506 can be made up of metal such as stainless steel, or superelastic alloy such as Nitinol.In the range of 0.05mm to 0.25mm The diameter of cored wire 1508 can be suitable.Sacculus 1508 can have compliance, semi-compliant or non-compliance construction.Sacculus 1508 can Include the preforming shape of the outline with Eustachian tube.Sacculus 1508 may include to be used for deliver this in part or all of expansion The micropore of any of therapeutic substance disclosed in text.Sacculus 1508 may include to be used to deliver therapeutic substance disclosed herein Any of coating.Equipment 1500 may include the hurtless measure end 1510 in spherical form, and hurtless measure end 1510 can It is integral with cored wire 1506.Equipment 1500 may include the accessory 1511 in the proximal portion of axle 1502, for insert 1504 provide fluid, energy and electric signal.Therefore, equipment 1500 may include the tube chamber for enabling flow through.Equipment 1500 is not Need for inserting the seal wire in Eustachian tube, but optionally use seal wire.
Can be by grasping axle 1502 and by checking that insert is directed to nose by mirror, fluoroscopy or transillumination In chamber passage and nasopharynx and enter in Eustachian tube to be manually inserted into equipment 1500.Therefore, the part of equipment 1500 may include ray Impermeable coating or material.Insert 1504 may include optical fiber, for transmission light to carry out transillumination.The example of transillumination equipment exists Shown in commonly assigned U.S. Patent Application Serial Number 10/829,917 and 11/522,497, the entire disclosure of which is to draw It is incorporated herein with mode.Insert 1504 may also include CCD or CMOS cameras and related wiring, for endoscopic observation without having Have and individually check mirror.Equipment 1500 also may link to 3D tracking systems.
Shown insert 1504 is only example, and may include other constructions, such as bare wire.Bare wire can deliver energy Amount, such as resistance heat, ultrasonic wave or electrosurgical energy (such as RF).Energy also can for example pass through hot fluid or gas by sacculus 1504 Body delivers.
Insert 1504 can also deliver the support for supporting Eustachian tube or expanding Eustachian tube.Support may include polymer Material, the polymeric material can elute any of therapeutic substance disclosed herein.
Insert 1504, which may also reach, to be pulled down from axle 1504 to be delivered in Eustachian tube.In one example, insert 1504 can be made up of Biodegradable polymeric such as PLA, and Biodegradable polymeric may also comprise disclosed herein Any of therapeutic substance.Being inserted into part 1504 can degrade over time, and deliver therapeutic substance as needed. Biodegradable insert 1504 may also include the tube chamber for the drainage of fluid in Eustachian tube.
Figure 15 B show the alternative equipment 1512 for being used to treat Eustachian tube according to an embodiment.Equipment 1512 is main Construct as shown in fig. 15, but the embodiment includes stiff shaft 1514, stiff shaft 1514 includes priority bending portion 1516.It is curved Pars convoluta 1516 can be in the range of 30 degree to 90 degree.Bending section 1516 allows to more easily enter pharynx drum in some anatomical structures Pipe.
Figure 15 C show the equipment 1500 or 1512 in the use according to an embodiment.Shown equipment 1500, which has, puts Put the insert 1504 in Eustachian tube ET.Insert 1504 is preferably deformed to match Eustachian tube ET profile, and therefore Therapeutic agent can be delivered without making Eustachian tube ET deformations or undermined.Alternatively, insert 1504 is preformed to match Eustachian tube Profile, and positioning when be slightly distorted.Insert 1504 also includes column stiffness, and the column stiffness is sufficiently large to prevent insert The warpage between Eustachian tube ET mid-terms are inserted, and therefore prevent from causing damage to equipment or Eustachian tube ET.
Figure 15 D show the equipment 1500 or 1512 in the use according to an embodiment.In this embodiment, equipment 1500 supports 1518 including that can be expanded in Eustachian tube ET.Support may include the marmem structure expanded by sacculus 1508 Make or deformable construction.
Figure 15 D show the equipment 1500 or 1512 in the use according to an embodiment.In this embodiment, equipment 1500 include dismountable insert 1520.Dismountable insert can be dismantled at junction surface 1522.In this example, insert Part 1520 includes tube chamber.Insert 1520 can be biodegradable and deliver therapeutic substance over time.In a reality Apply in scheme, insert 1520 may include the attachment members of the mucosal tissue for being attached to insert 1520 in nasal cavity, make Zone migration therein will not be placed to from it by obtaining insert 1520.The attachment members (or multiple components) can be in insert Insert 1520 is attached at or near 1520 proximal ends so that when insert 1520 is placed in Eustachian tube, attachment Component extends in nasal cavity and can be attached to mucosal tissue by doctor.Can be in various embodiments using any suitable Attachment members, such as, but not limited to suture loop, fixture, barb etc..
Figure 15 F show another alternative embodiment of the Eustachian tube expansion device 1530 of no seal wire.In the embodiment In, expansion device 1530 includes the shank 1532 and ductility guiding elements (or " axle ") coupled with sliding foley's tube 1540 1544, foley's tube 1540 slides on the ductility guiding elements 1544.Suction orifice 1534, inflate aperture 1536 and slide Dynamic actuator 1538 also couples with shank 1532, for the foley's tube 1540 that promotes and bounce back along guiding elements 1544.In the reality Apply in scheme, foley's tube includes rigid portions of proximal 1541, distal side flexible portion 1546 and balloon-expandable 1548.Guide structure Part 1544 may include bulb 1542, and bulb 1542 is similar to see and passed through during sinus surgery by ENT doctor Those in the distal end of the bulb seeker often used.Proximal shaft segment 1541 can be by any suitable material system Into.For example, in one embodiment, proximal shaft segment 1541 can be stainless steel hypotube.Flexible distal shaft portion 1546 can It is made up of any flexible material such as flexible polymer, and sacculus 1548 can be by any suitable non-compliance, semi-compliant Or conforming materials are made, including but not limited to PET, nylon or Pebax.In various embodiments, guiding elements 1544 can To be flexible, ductility or rigid, and can be made up of stainless steel, Nitinol or any other suitable material.
In use, expansion device 1530 can be advanced in nostril, and guiding elements 1544 and its bulb 1542 Available for the opening for searching out and navigating to up to Eustachian tube, this finds paranasal sinus with ENT doctor using bulb seeker The mode of opening is identical.Once positioning Eustachian tube opening, guiding elements 1544 can be promoted by opening, and sliding actuator 1538 can be pushed into along the slit (in Figure 15 F invisible) in shank 1532, to promote foley's tube along guiding elements 1544 1540.Promote foley's tube 1546 that sacculus 1548 is positioned to the desired locations in Eustachian tube.Then sacculus 1548 can be through Inflated by inflating aperture 1536, with a part for expansion/expansion Eustachian tube, then sacculus 1548 can be released.Then can be by ball Capsule 1548 removes from patient's body, is repositioned in identical Eustachian tube to expand extention, or is repositioned onto offside pharynx Tympanic canal is to expand the pipe.The code can perform any group of the position repeatedly and with patient with patient as needed Performed in conjunction.Opening that in some embodiments, expansion device 1530 can also be used to be expanded in paranasal sinus (or by multiple noses Sinus opening).Paranasal sinus opening expansion can Eustachian tube expansion before or after perform, and can involve frontal lobe, sphenoid sinus, Opening in maxilla or sieve sinus.In some embodiments, expansion device 1530 can remove between expansion from patient's body, To allow user that the ductility part of guiding elements 1544 is bent into different angles, in order to enter different sinus and/ Or Eustachian tube opening.
In an alternative embodiment, guiding elements 1544 can be outer tube, and foley's tube 1540 is promoted by the outer tube. This pipe can predominantly rigid, part it is rigid/partially flexible or it is most of flexible.Embodiment is selected else at another In, guiding elements 1544 may include both interior axle and outer tube.In still another embodiment, foley's tube 1540 can be regularly attached It is connected to guiding elements 1544 (or axle).In another embodiment, can there is no guiding elements, but be simply rigidity or portion Point rigid and/or ductility foley's tube 1540, foley's tube 1540 can by self-propelled into Eustachian tube without making Use guiding piece.In other embodiments, any other suitable expansion device can replace foley's tube 1540, such as but unlimited In mechanical expanders, such as inflatable wire basket including multiple pointed tooths.
Figure 16 A and Figure 16 B show the method for being used to provide treatment to the Eustachian tube of patient according to an embodiment. Before performing treatment method, doctor can apply local anaesthesia to nasal cavity and/or Eustachian tube.Situation about performing under general anesthesia Under, doctor may be selected not apply local anaesthesia, and in the case of being performed with conscious patient, local anaesthesia can be applied. Generally, this method may include desired any preparation/anaesthesia technology.In some embodiments, for example, doctor may be selected Perform nasal irrigation and/or Eustachian tube before treating.This can be the supplement of anesthesia or enter in the case where local anaesthesia is inapplicable OK.
After the preparation of any desired nasal cavity and/or Eustachian tube, guiding catheter 1600 is directed through patient's The opening placement of nasal passage and neighbouring Eustachian tube ET.In various embodiments, guiding catheter 1600 can by homonymy or Offside nostril is advanced to Eustachian tube, and generally guiding catheter 1600 will have differently curved angle according to method.Shown Embodiment in, the distal part 1602 of guiding catheter 1600 include between 30 degree and 90 degree angle (or There is any other angle in alternative embodiment) bending section.In one embodiment, distal part 1602 is comparable draws The portions of proximal of conduit 1600 is more flexible.In one embodiment, the distal part 1602 of guiding catheter can be to extend Property.Therefore, user can be bent distal part 1602, and guiding catheter 1600 is placed on into expectation relative to Eustachian tube ET Position in.
After guiding catheter 1600 is in desired position, then seal wire 1604 can be pushed through guiding catheter 1600 and entrance Eustachian tube ET.In the embodiment illustrated, seal wire 1604 includes bulb 1603, to prevent seal wire 1604 Through the small diameter portion in the distal side of Eustachian tube.Other embodiments may include bending distal end or other stop mechanisms with Realize identical purpose.As described above, although the embodiment of the method for treating Eustachian tube is related to guiding catheter 1600 With seal wire 1604, but alternative treatment method can only relate to guiding catheter 1600, only relate to seal wire 1604, or can be not any Performed in the case of guiding equipment.
In fig. 16b, dilating catheter 1606 promotes on seal wire 1604 and by guiding catheter 1600, will expansion The expander 1608 of conduit 1606 is positioned in Eustachian tube ET., can be on seal wire 1604 in an alternative embodiment The Optional of dilating catheter 1606 is promoted to remove guiding catheter 1600 from patient's body.In another selects embodiment else, Dilating catheter 1606 can be advanced in Eustachian tube in the case of without using seal wire 1604 by guiding catheter 1600.Dilating catheter 1606 generally include slender axles and expander 1608.Expander 1608 can be polymer sacculus (compliance, semi-compliant or non-suitable Answering property).In some embodiments, sacculus can be porous, to deliver therapeutic agent or diagnosticum in pressurization.Alternatively, expand Prop 1608 can be by any one structure in multiple metals or polymer pointed tooth or many other suitable mechanical expansion equipment Into machinery may expand basket.Dilating catheter 1606 is generally included for making that expander 1608 inflates/activate proximally-oriented Connector/configuration.Therapeutic agent or diagnosticum for example can expand via the spray conduit or spraying tube chamber of guiding catheter 1600 in insertion Eustachian tube ET inside is applied to before or after opening conduit 1606.In one embodiment, for example, dilating catheter 1606 can It is (or more including introducing tube chamber for the fluid that is introduced into rinse fluid art, volatile anaesthetic liquid, medicine or other materials in Eustachian tube Individual tube chamber).In one embodiment, it can be used the identical tube chamber or single tube chamber by fluid/material from Eustachian tube Pump out.
Expander 1608 can be expanded to expand Eustachian tube ET after it is placed on the desired position in Eustachian tube.Example Such as, Eustachian tube ET open area includes pharynx mouth, and can promote dilating catheter 1606 so that expander 1608 is positioned at into pharynx mouth In.Endoscope can be used to assist to position dilating catheter 1606.Endoscope can be promoted by nasal passage to observe dilating catheter 1606.Can be from the mark on the axle of endoscopic observation dilating catheter 1606, with based on proximal end of the mark from expander 1608 The position apart from Approximation Extensions device 1608 relative to Eustachian tube ET opening in portion.Therefore, dilating catheter 1606 can move with Mark is placed in desired position before expander 1608 expands in Eustachian tube ET.
Expander 1608 can (such as some seconds or some minutes) be held in place by for a long time in the expanded state.Expand One or more in all therapeutic agents as described herein of material or diagnosticum can be also delivered to Eustachian tube ET by prop 1608.Expand Prop 1608 can also carry the expandable stent for being delivered to when expander 1608 expands in Eustachian tube.In expander 1608 Released/it is unexpanded after, can by dilating catheter 1606, guiding catheter 1600 and seal wire 1604 from patient's body remove.
As described above, in an alternative embodiment, sacculus dilating catheter sometimes can without using seal wire, lead It is advanced in Eustachian tube in the case of pipe or other guiding equipment and is used in Eustachian tube.This foley's tube will need to have Enough integral rigidities, to allow it in the case of no guiding equipment through nasal cavity and enter in Eustachian tube, but manage With thinking, at least distal part of conduit also will be sufficiently flexible to be advanced in Eustachian tube and conform to the Eustachian tube of complications Shape, without causing unnecessary harm.In some embodiments, this sacculus dilating catheter can along its length at least A part has adjustable rigidity.For example, in one embodiment, conduit can have ductility part, doctor user It can be adjusted before insertion with his/her hand.However, even can more advantageously have can be promoted with a certain amount of rigidity Into Eustachian tube, the conduit of different amounts of rigidity is then adjusted to.For example, it may be desirable to it is relatively hard until its distal end Through entering in Eustachian tube, and then can be made into more flexible further to trace into the conduit in Eustachian tube.At one In embodiment, slip can be used to strengthen mandrel to realize for adjustable rigidity, slip reinforcement mandrel extends to its of conduit The middle distal part for it is expected stiffness tuning and the sliding component proximally extended on the shank or portions of proximal of conduit, are used Person is adjusted using the sliding component.In other embodiments, stiffener (or multiple components) may include one or more Individual cored wire, ribbon, compressible fluid etc..Proximal member for controlling rigidity may include sliding block, rotating disk, button or other causes Dynamic device.
Figure 17 shows the illuminating guidewire 1700 in the use according to an embodiment.Illuminating guidewire 1700 with above-mentioned to lead 1604 identical modes of silk use.However, illuminating guidewire 1700 provides illumination at distal end 1702, distal end 1702 is logical Cross eardrum or on the external of patient for user visible (commonly referred to as " transillumination ").User can be based on through patient's Distal end 1702 is placed on desired opening position by the position of the luminous point 1704 of tissue.Luminous point 1704 can be used as datum mark, with For placing miscellaneous equipment based on the relative distance with luminous point 1704.Luminous point 1704 can also be the pharynx for observing Eustachian tube ET The endoscope of mouth provides secondary light source or principal light source.Illuminating guidewire 1700 may include to be used to light being delivered to distal side end from light source The optical fibre channel at end 1702.With reference to the illuminating guidewire that present disclosure uses and the example of mirror can be checked in the commonly assigned U.S. Show and describe in patent application serial number 11/522,497, the entire disclosure of which is herein incorporated by reference.
Figure 18 A and Figure 18 B show the dilating catheter 1800 according to alternative embodiment.Dilating catheter 1800 includes detachable Expander 1802.Before detachable expansion device 1802 expands in Eustachian tube ET, detachable expansion device 1802 can be from expansion Conduit 1800 is opened to pull down.Detachable expansion device 1802 may include check valve, and check valve allows detachable expansion device 1802 from expansion Open after conduit 1800 is pulled down and keep expansion.The engageable detachable expansion device 1802 of joint and dilating catheter 1800 that can be broken. Detachable expansion device 1802 may include at least one tube chamber to allow pressure fluid to pass through.In use, dilating catheter 1800 can A part for expansion Eustachian tube is positioned and is expanded into, as described in previous embodiment.In the inflation of detachable expansion device 1802 Afterwards, can be pulled down via the twisting resistance or pulling force for the proximal portion for being applied to dilating catheter 1800 in the joint that can be broken removable Unload expander 1802.Check valve prevents detachable expansion device 1802 from being released after being pulled down from dilating catheter 1800.It is removable Unloading expander 1802 may include therapeutic agent or diagnosticum to treat Eustachian tube ET.Pressure in Eustachian tube ET can be put down via tube chamber Weighing apparatus, and detachable expansion device 1802 keeps expansion wherein.Detachable expansion device 1802 can be by the way that it be pulled out from Eustachian tube ET And be removed, and can also be removed in some embodiments by puncturing detachable expansion device 1802.
Figure 18 C show the dilating catheter 1804 according to alternative embodiment.Dilating catheter 1804 includes multiple extendible Pin 1806, pin 1806 can extend through the passage in expander 1808.Each pin 1806 can be fluidly connected to therapeutic agent or diagnosis Agent source, such as syringe.Different pins 1806 may be coupled to different types of therapeutic agent or diagnosticum.In use, expand Conduit 1800 can position and be expanded into a part for expansion Eustachian tube, as described in previous embodiment.Filled in expander 1808 After swollen, pin 1806 can promote by expander 1808 and enter Eustachian tube ET tissue.Then, pin 1806 can by a kind of or In polytype therapeutic agent or diagnosticum injection Eustachian tube ET tissue, as shown in material plume P.Had been injected into material After in Eustachian tube ET tissue, pin can be withdrawn into dilating catheter 1804, and can be by dilating catheter 1804 from Eustachian tube ET is removed.
Figure 18 D show the dilating catheter 1810 of the alternative embodiment according to dilating catheter 1606.Dilating catheter 1810 wraps At least one pair of relative flank 1812 is included, flank 1812 helps to maintain position of the expander 1814 in Eustachian tube ET.It can be used Relative flank 1812 more than a pair.Flank 1812 need not be directly opposite each other positioning, and odd number flank can be used 1812 configuration.Flank 1812 can be made up of elongated pointed tooth, and these pointed tooths are biased by the spring to leave expansion being pushed into Expanded during the axle 1816 of conduit 1810.Extracting the flank 1812 slidably received out will cause them to be collapsed in axle 1816.Side The wing 1812 for example can be manipulated by actuated slider mechanism at the proximal end of dilating catheter 1810.Flank 1812 can be with Including spike or holder to help to maintain the immovable contact with Eustachian tube ET.In use, expander 1814 and flank 1812 are not pushed into simultaneously or simultaneously and leave axle 1816 (that is, flank 1812 can be pushed away before or after expander 1814 Enter).For flank 1812 to the wall applying power of Eustachian tube ET opening, this help maintains expander 1814 in desired position. After desired therapeutic agent is applied to Eustachian tube ET by expander 1814, flank 1812 can be withdrawn into axle 1816.
Figure 18 E to Figure 18 T show the various views of the alternative embodiment of expander 1608.Such as Figure 18 E to Figure 18 G The expander 1817 with tapered conical by its shape is shown, the shape and Eustachian tube ET tapered geometry are complementary, with enhancing Eustachian tube ET expansion.The tapered conical shape of expander 1817 is straight by proximal end 1832, tapered proximal face 1830, maximum Footpath 1831, tapered distal surface 1818 and distal end 1833 are formed.In this example, tapered distal surface 1818 has about 12 The longitudinal length of millimeter to 18 millimeters, maximum gauge 1831 have about 6.5 millimeters of diameter, and proximal end 1832 and distal side End 1833 has about 4.5 millimeters of diameter.Alternatively, can be used any other suitably sized.Expander 1820 can also have There are shape-variable, such as stairstepping shown in Figure 18 H.Using the stairstepping, expander 1820 has at least two differences External diameter-extend along the proximal length of expander 1820 first external diameter and along expander 1820 distal length extend the Two external diameters, there is angled transition part between these external diameters.
By whole circumference along Eustachian tube ET, uniformly contact may occur in which expanding Eustachian tube ET and asks expander 1817,1820 Topic.When expander 1817,1820 expands in Eustachian tube, air due to the volume of expander 1817,1820 increase and by It is mobile.If air is advanced towards middle ear 14, rather than advances towards the nasopharyngeal area of larynx 30, then pressure can be established in middle ear 14 In, so as to cause that eardrum 22 may be damaged.Pressure can partly establish expander 1817,1820, as in Eustachian tube ET Sealing.Fluid communication is provided between the proximal end 1832 and distal end 1833 of expander 1817,1820 can help to discharge The buildup of pressure that can occur due to expanse device 1817,1820 in middle ear 14.In other words, when making expanse device 1817th, when 1820 expansions start to occupy the space in Eustachian tube ET side zones, there is provided allow air from Eustachian tube ET side The ventilation path escaped to region can be beneficial.It is additionally, since the expansion of expander 1817,1820 and controls by mobile sky The direction of gas, which may also aid in, prevents the possible buildup of pressure in middle ear 14.Only it is that can be used for preventing the pressure in middle ear 14 below Accumulation also provides the Eustachian tube ET distinct device of expansion and the illustrated examples of method simultaneously.With reference to teaching herein content, The other examples of apparatus and method will be apparent for those of ordinary skills.It should be appreciated that retouch below The method and expander feature stated can combine in a variety of ways, to help prevent undesirable buildup of pressure in middle ear 14.
As shown in Figure 18 E and Figure 18 H, expander 1817,1820 can be attached to axle 1822, and axle 1822 extends through expansion Both the proximal end 1832 and distal end 1833 of device 1817,1820.Axle 1822 includes extending through expander 1817,1820 Ventilation tube chamber 1834, positioned at one group of nearside pressure relief vent 1824 of the nearside of proximal end 1832, and distally located end 1833 One group of distal side pressure relief vent in distal side.Pressure relief vent 1824 is orientated laterally across axle 1822.Pressure relief vent 1824 can be via ventilation tube chamber 1834 provide fluid communication between the proximal end 1832 and distal end 1833 of expander 1817,1820.The fluid communication Path can be used for preventing the expansion of expander 1817,1820 from providing buildup of pressure in middle ear 14, so as to be carried in Eustachian tube ET Voltage supply dynamic balance.In other words, when expander 1817,1820 inflates, Eustachian tube ET positioned at the region in 1817,1820 distal sides In air can be escaped via pressure relief vent 1824 because inflation expander 1817,1820 occupies Eustachian tube ET distal region. What the quantity of the pressure relief vent 1824 shown in Figure 18 E and Figure 18 H was merely exemplary.If desired, axle 1822 may include it is additional Or less pressure relief vent 1824.It is also understood that axle 1822 is by including available for making what expander 1817,1820 was inflated/released Individually inflation tube chamber (not shown).This inflation tube chamber will be with the fluid isolation of tube chamber 1834 of ventilating.In addition, expander 1817, 1820 expandable part will be with the fluid isolation of tube chamber 1834 of ventilating.
Figure 18 I to Figure 18 N show the cross-sectional geometry with the whole circumference for not contacting and occupying Eustachian tube ET Exemplary expander 1850,8900,9000,9100,9200, so as to inflation when allow expander 1850,8900,9000, 9100th, the fluid communication between 9200 proximal end and distal end.Therefore, as described in more detail below, expander 1850th, 8900,9000,9100,9200 cross-sectional geometry prevents sealing effect.
Figure 18 I to Figure 18 J show an exemplary cross section geometry with expander 1850.Expander 1850 wraps Include proximal end 1856, distal end 1851, tube chamber 1853, multiple lug bosses 1854 separated by multiple depressed parts 1855 and gradually Contracting surface 1852.In this example, tapered surface 1852 is located in both proximal end 1856 and distal end 1851.However, Tapered surface 1852 is only optional, and may reside on an end or do not exist.In this example, lug boss 1854 are angularly spaced around the longitudinal axis that is limited by axle 1822 is equally spaced from each other.The shape of cross section of expander 1850 by The consecutive intervals of lug boss 1854 and depressed part 1855 are formed；And it is generally similar to "+" number.When expander 1850 inflates, The shape of cross section of expander 1850 provides the Limited contact with Eustachian tube ET, so as to prevent sealing effect.In other words, Depressed part 1855 provides the ventilation path of the length along expander 1850.Optionally, as in expander 1817,1820, Using the pressure relief vent through proximal end 1856 and distal end 1851, to provide additional release.In addition, tapered surface 1852 need not be uniform, but can have the change in size of the tapered surface 1818,1830 similar to expander 1817, from And allow the complementary fit of expander 1850 and the Eustachian tube ET of patient.
Figure 18 K to Figure 18 P show the cross-sectional geometry for having change along the length of expander 8900,9000,9100 Expander 8900,9000,9100 example；But when inflation still in the proximal end of expander 8900,9000,9100 Fluid communication is provided between distal end.
For example, Figure 18 K and Figure 18 L show expander 8900, it includes proximal end 8904, distal end 8907, by ring Flank 8901 that shape depressed part 8902 separates, proximally end 8904 extends to the longitudinally concave portion 8905 of distal end 8907 And the axle 8903 with the tube chamber 8904 for extending through expander 8900.Flank 8901 is the expander contacted with Eustachian tube ET Face, and annular recess 8902 and longitudinally concave portion 8905 are provided between proximal end 8904 and distal end 8907 The path of fluid communication, so as to prevent any when expander 8900 inflates may causing buildup of pressure unnecessary in middle ear 14 Sealing effect.Optionally, as in expander 1817,1820, can be utilized in axle 8903 through expander 8900 The pressure relief vent of proximal end 8904 and distal end 8907, to provide additional release.In addition, the length along expander 8900 Size need not be uniform, but can have the change in size of the tapered surface 1818,1830 similar to expander 1817, from And allow the complementary fit of expander 8900 and the Eustachian tube ET of patient.
Figure 18 M and Figure 18 N show another example, and wherein expander 9000 includes proximal end 9004, distal end 9005th, dilator body 9002, discrete lugs 9001 and the axle 9003 with the tube chamber 9006 for extending through expander 9000.From Projection 9001 is dissipated can symmetrically or randomly to place along dilator body 9002.When expander 9000 inflates, discrete lugs 9001 can contact with the Eustachian tube ET of patient.Discrete lugs 9001 have enough rigidity for use as dilator body 9002 and suffered from Distance piece between the Eustachian tube ET of person.By providing space between dilator body 9002 and Eustachian tube ET, discrete is convex In space of the block 9001 when expander 9000 inflates between the proximal end 9004 and distal end 9005 of expander 9000 Ventilation path is provided.Thus fluid communication between proximal end 9004 and distal end 9005 prevents any sealing effect, should Sealing effect can cause unnecessary buildup of pressure when expander 9000 inflates in middle ear 14.Optionally, such as in expander 1817th, it is the same in 1820, proximal end 9004 and distal end 9005 through expander 9000 can be utilized in axle 9003 Pressure relief vent, to provide additional release.In addition, need not be uniform along the size of the length of expander 9000, but can have There is the change in size of the tapered surface 1818,1830 similar to expander 1817, so as to allow the pharynx of expander 9000 and patient Tympanic canal ET complementary fit.
Figure 18 O and Figure 18 P show wherein expander 9100 include proximal end 9102, distal end 9104, main body 9103, Along the example of the spiral rib 9101 of main body 9103 and the axle 9105 with the tube chamber 9106 for extending through expander 9100.When When expander 9100 inflates, spiral rib 9101 provides the contact with the Eustachian tube ET of patient, so as to prevent dilator body 9103 provide sealing effect.In other words, spiral rib 9101 provides edge and is limited between main body 9103 and Eustachian tube ET wall Space helical vent path.Therefore, proximal end 9102 and distal end of the spiral rib 9101 in expander 9100 Ventilation path is provided between 9104.Optionally, as in expander 1817,1820, can be utilized on axle 9105 through expansion The proximal end 9102 of prop 9100 and the pressure relief vent of distal end 9104, to provide additional release.In addition, along expander The size of 9100 length need not be uniform, but can have the tapered surface 1818,1830 similar to expander 1817 Change in size, so as to allow the Eustachian tube ET of expander 9100 and patient complementary fit.It should be noted that it can be used more than one Individual spiral rib 9101.
Figure 18 Q and Figure 18 R show an example of expander 9200, it include proximal end 9402, distal end 9205, Main body 9202, along main body 9202 outside Longitudinal extending fin 9201 and with extending through proximal end 9204 and distal side The axle 9203 of the tube chamber 9206 of end 9205.When expander 9000 inflates, fin 9201 can contact with the Eustachian tube ET of patient. Fin 9201 has enough rigidity, for use as the distance piece between dilator body 9202 and the Eustachian tube ET of patient, so that Prevent the wall of Eustachian tube from being sealed against main body 9202.Therefore, when fin 9201 connects when expander 9200 inflates with Eustachian tube ET When touching, fin 9201 provides ventilation path between the proximal end 9204 and distal end 9205 of expander 9200.This ventilation Path can prevent that unnecessary buildup of pressure can occur in middle ear 14 due to the inflation of expander 9200.Optionally, such as exist It is the same in expander 1817,1820, proximal end 9204 and distal end through expander 9200 can be utilized on axle 9203 9205 pressure relief vent, to provide additional release.In addition, need not be uniform along the size of the length of expander 9020, but There can be the change in size of the tapered surface 1818,1830 similar to expander 1817, so as to allow expander 9200 with suffering from The Eustachian tube ET of person complementary fit.
Figure 18 S to Figure 18 T show the example of expander 9300, and it includes proximal end 9302, distal end 9304, main body 9307th, with the out-of-alignment breather pipe 9301 of main body 9307 and with the proximal end 9302 for extending through expander 9300 and far The axle 9303 of the tube chamber 9306 of side end 9304.Breather pipe 9301 can be attached to main body 9307, and therefore with main body 9307 Insert simultaneously in the Eustachian tube ET of patient.Alternatively, breather pipe 9301 can be pulled down from main body 9307, so as to allow by main body By in the Eustachian tube ET for the tube chamber insertion patient that ventilates before or after in the Eustachian tube ET of 9307 insertion patients.Breather pipe 9301 has There are the distal end of opening and the proximal end of opening, wherein tube chamber extends therebetween.Therefore breather pipe 9301 is effectively expanding Ventilation path is provided between the proximal end 9302 and distal end 9304 of prop 9300.By the interior tube chamber of breather pipe 9301, By the space S (Figure 18 T) between Eustachian tube ET wall and the region of breather pipe 9301 and the wall of main body 9307, or pass through two Ventilation is realized in the combination of person.Ventilation prevents sealing effect, and otherwise sealing effect can cause middle ear 14 when expander 9300 inflates In unnecessary buildup of pressure.
There is provided by the geometry of expander 1818,1820,1850,8900,9000,9100,9200,9300 for leading to The path of gas is only the example that buildup of pressure in middle ear 14 is prevented during Eustachian tube ET is expanded.Only said as another The example of bright property, Figure 18 U to Figure 18 W show the controlled inflation of expander 9500, so as to force the pharynx of air towards patient to be roused Pipe ET inside region enters the nasopharyngeal area of larynx 30.In Figure 18 U, expander 9500 is in Eustachian tube ET in shape of releasing State.In Figure 18 V, air is introduced into expander in a manner of causing the distal end 9501 of expander 9500 to inflate first 9500.The distal end 9501 of expander 9500 is inflated first and force air on nearside or interior side direction, such as Figure 18 U to figure Shown in arrow in 18W.The distal end 9501 of expander 9500 provides sealing effect, so as to exclude the pressure from middle ear 14 Air.As additive fluid is sent to expander 9500, expander 9500 continues the length along expander 9500, from expander 9500 distal end/outboard end 9501 is gradually expanded towards proximal end/medial end 9502 of expander 9500.Figure 18W shows that both proximal end 9502 and distal end 9501 are expanded, so as to expand Eustachian tube ET.
Expansion distal end 9501 first is may be implemented in a variety of ways, then proximally facing end 9502 is advanced.It is such as logical Cross and the distal end 9501 of expander 9500 is designed to have the wall thickness smaller than the proximal end 9502 of expander 9500 can To realize that distal side inflates.Alternatively, distal end 9501 can the small material of the density of material including density ratio proximal end 9502 Material, therefore allow distal end 9501 to inflate first.In another selects embodiment else, can have and surround expander 9500 Outside retractable external jacket.Sheath can be initially placed in distal position, and then be inflated in expander 9500 When proximally can slowly bounce back.With reference to teaching herein content, first inflate the distal end 9501 of expander, Ran Houchao The other methods advanced to proximal end 9502 will be apparent for those of ordinary skills.
Figure 18 X show cutting (or " delineation ") balloon dilatation catheter 1826 according to alternative embodiment.Balloon dilatation catheter 1826 include the cutting element 1828 around the placement of its exterior circumferential.In various embodiments, cutting element 1828 can be line, Sharp projection of sharp blade, single line or a piece of sharp blade, small barb or protuberance etc..Cutting element can be configured Into delivering energy (such as RF).In use, cutting element 1828 is expanded together with expander to impinge upon on Eustachian tube ET, this Expander is allowed to open and stretch along controlled location.Figure 18 Y and Figure 18 Z show treated Eustachian tube ET before treatment and it Expression afterwards.Allow the elastic response by obstructing Eustachian tube ET walls at least in part along controlled section 1829 cutting Eustachian tube ET To make Eustachian tube ET maintain inflated configuration.
In the alternative embodiment of Cutting balloon expander 1826, cutting element 1828 can be only along the circumference of sacculus 1826 A part setting.This can be favourable, because in some cases, the only a part for delineating the circumference of Eustachian tube can be can the phase Hope.In some cases, for example, it can be below desirable only to delineate Eustachian tube, it may be possible to will be to because of the part The mode of prestige is reacted to the treatment.Equally in various embodiments, cutting element 1828 can have various suitable high Degree, acutance or other cutting characteristics, to provide different cutting horizontal/depth.This can be favourable, because being roused in different pharynxs Guan Zhongke it is expected different depths of cut.
In the various embodiments of the method for treating Eustachian tube, support can be used for the enlarged portion for strutting Eustachian tube Point, deliver drugs into Eustachian tube or not only strut the expansion of Eustachian tube but also deliver drugs into Eustachian tube.Figure 19 A show root According to the support 1900 of an embodiment.Support 1900 is configured to diameter, and distally part 1902 is gradual to portions of proximal 1904 Increased tapered coils.The shape of coil can be similar with the size of Eustachian tube ET pharynx mouth, to strengthen Eustachian tube ET expansion.Branch Frame 1900 can be made up of ductility or marmem.Alternatively, support 1900 can be made up of Biodegradable polymeric. Support 1900 can be configured to such as carry via the Biodegradable polymeric coating containing certain material and deliver this Material, all any of therapeutic agent or diagnosticum as disclosed herein.Polymer coating can include with based on lactic acid or ethanol The material matrix of biodegradable polymer blendings sour or based on other materials, including poly- (Lanthanum Isopropoxide), poly- (Sanya Methyl carbonic) copolymer, and poly- (- caprolactone) homopolymer, and the copolymer of polyanhydride, poe or polyphosphazene.Support 1900 can be by all carryings of any of dilating catheter as disclosed herein of dilating catheter and delivering.In use, as illustrated, Support 1900 maintains the mechanical swelling of Eustachian tube ET opening.Alternatively, support 1900 can be configured to against Eustachian tube ET walls Apply minimum power to provide it mechanical assistance.Support can be permanently placed in Eustachian tube ET, or is moved later Remove.It should be appreciated that the round configuration of the opening due to support 1900, when support 1900 is positioned in Eustachian tube ET, support 1900 can provide substantially unimpeded path, for the ventilation by Eustachian tube ET.
Figure 19 B show the support 1906 according to another embodiment.Support includes connecting multiple inflatable pointed tooths 1910 Connecting elements 1908.Pointed tooth 1910 can be made up of ductility or marmem.Alternatively, pointed tooth 1910 can by biology The polymer of degraded is formed.Pointed tooth 1910 can be configured to for example apply via the Biodegradable polymeric containing certain material Layer carries and delivered the material, all any of therapeutic agent or diagnosticum as disclosed herein.Polymer coating can include The material matrix being blended with the biodegradable polymer based on lactic acid or glycolic or based on other materials, including it is poly- (to two Oxygen cyclohexanone), PTMC copolymer, and poly- (- caprolactone) homopolymer, and polyanhydride, poe or poly- The copolymer of phosphonitrile.Pointed tooth 1910 can be by all carryings of any of dilating catheter as disclosed herein of dilating catheter and delivering. Pointed tooth 1910 can be configured to the radially self-expanding when being removed from limitation axle or be expanded by the power from sacculus.Using In, as illustrated, support 1906 maintains Eustachian tube ET mechanical swelling.Alternatively, support 1906 can be configured to rouse against pharynx Pipe ET walls apply minimum power to provide it mechanical assistance.Support 1906 can be permanently placed in Eustachian tube ET, or It is removed later.It should be appreciated that due to the open configuration of support 1910, when support 1910 is positioned in Eustachian tube ET, support 1910 can provide substantially unimpeded path, for the ventilation by Eustachian tube ET.
Figure 19 C and Figure 19 D show the support 1910 according to another embodiment.Support includes distal side connecting elements 1912 With removable nearside connecting elements 1914, the distal side connecting elements 1912 and removable nearside connecting elements 1914 connect it is multiple can Expand pointed tooth 1916.Pointed tooth 1916 can be made up of marmem.Alternatively, pointed tooth 1916 can be by biodegradable polymerization Thing is formed.Pointed tooth 1916 can be configured to for example via the Biodegradable polymeric coating containing certain material carrying and Deliver the material, all any of therapeutic agent or diagnosticum as disclosed herein.Polymer coating can include with based on lactic acid Or glycolic or the material matrix of the biodegradable polymer blending based on other materials, including poly- (Lanthanum Isopropoxide), PTMC copolymer, and poly- (- caprolactone) homopolymer, and the copolymerization of polyanhydride, poe or polyphosphazene Thing.Pointed tooth 1916 can be by all carryings of any of dilating catheter as disclosed herein of dilating catheter and delivering.Pointed tooth 1916 can It is configured to the radial direction self-expanding when being removed from limitation axle.In use, support 1906 is delivered via delivery catheter.Then may be used To remove removable nearside connecting elements 1914, so that the portions of proximal expansion of support 1910, and therefore make Eustachian tube ET's Swallow mouth expansion.Once in placing in position, support 1906 just maintains Eustachian tube ET mechanical swelling.Alternatively, pointed tooth 1916 can be configured to apply minimum power against Eustachian tube ET walls to provide it mechanical assistance.Support 1910 can be for good and all It is placed in Eustachian tube ET, or be removed later.It should be appreciated that due to the open configuration of support 1910, when support 1910 is fixed When position is in Eustachian tube ET, support 1910 can provide substantially unimpeded path, for the ventilation by Eustachian tube ET.
Figure 20 A, Figure 20 B and Figure 20 C show to be configured according to the distal side of the guiding catheter 1600 of various embodiments.Shown Distal end may be configured to enter Eustachian tube ET, so that miscellaneous equipment can promote wherein.Figure 20 A show bevelled End 2002, its permission are more easily entered in Eustachian tube ET via the leading edge of reduction.Figure 20 B show tapered end 2004, its Permission is more easily entered in Eustachian tube ET via the leading edge of reduction.Figure 20 C show bulbous end 2006, and it causes guiding catheter 1600 can seal Eustachian tube ET via increased sealing area.End can be by flexible material such as silicones or rubber structure Into the material provides the excellent sealing ability with Eustachian tube ET.In use, end can seal Eustachian tube ET and be used to treat, Such as pressurize, aspirate and/or material is administered to Eustachian tube ET.
Figure 21 A and Figure 21 B show the insert 2100 according to an embodiment.Insert includes center slender axles 2102, the center slender axles 2102 have multiple support members 2104 from its circumferentially extending.Each support member 2104 is connected to outer Portion's component 2106, external member 2106 are used to place against Eustachian tube ET for rounding.Insert 2100 as depicted includes Three triangular support parts 2104, however, two or more support members 2104 can be used in alternative embodiment.Insert 2100 can be made up of the flexible polymer extruded from mould.Alternatively, insert 2100 can be by Biodegradable polymeric structure Into.External member 2106 can be configured to carry and delivered substance, any in all therapeutic agent as disclosed herein or diagnosticum Kind.Insert 2100 can be by all carryings of any of dilating catheter as disclosed herein of dilating catheter and delivering.Insert 2100 can be configured to the self-expanding when being removed from limitation axle.In use, support 1906 is delivered via delivery catheter.Once In placing in position, insert 2100 just maintains Eustachian tube ET mechanical swelling, as illustrated in fig. 21b.Insert 2100 carries For and maintain the open space 2108 in Eustachian tube ET, to maintain pressure therein balanced.Insert 2100 can be placed for good and all It is removed in Eustachian tube ET, or later.It should be appreciated that the opening of the offer of open space 2108 due to insert 2100 Configuration, when support 1910 is positioned in Eustachian tube ET, insert 2100 can provide substantially unimpeded path, for passing through pharynx Tympanic canal ET ventilation.
Figure 22 A show the filament insert 2200 according to an embodiment.Filament insert 2200 can be elongated alloy Or polymer filament, it is configured to all carryings of any of therapeutic agent or diagnosticum as described herein of material and delivering To Eustachian tube ET.Filament insert 2200 may be based on lactic acid or glycolic, or the polymerization of the biodegradable based on other materials Thing, including poly- (Lanthanum Isopropoxide), PTMC copolymer, and poly- (- caprolactone) homopolymer, Yi Jiju The copolymer of acid anhydride, poe or polyphosphazene.Filament insert can be flexible to conform to Eustachian tube ET passage.Filament Insert 2200 can be made up of some filaments with weaving configuration.Filament insert can include proximal ring 2201 with help from Eustachian tube ET is removed.
Figure 22 B, Figure 22 C and Figure 22 D are shown according to various embodiments for filament insert 2200 to be delivered into pharynx Tympanic canal ET delivery catheter.Delivery catheter 2202 is configured to axle, and including for keeping filament insert 2200 in outside Snare 2204.Delivery catheter 2202 may be configured to slide on seal wire 1604.In use, snare may be actuated 2204 to discharge the tension force on filament insert 2200, and allows filament insert 2200 to be removed from delivery catheter 2202.
Delivery catheter 2204 is configured in the outside axle for keeping filament insert 2200, wherein filament insert 2200 Distal part internally positions.Slidably cutting element 2206 is movably received within delivery catheter 2204.Delivery catheter 2204 may be configured to slide on seal wire 1604.In use, slidably cutting element 2206 is transported in a distal direction Move to cut filament insert 2200, for being pulled down from delivery catheter 2204.
Delivery catheter 2208 is configured to axle, and filament insert 2200 is maintained at the outer of delivery catheter 2208 by it in outside On surface.Delivery catheter 2208 may be configured to slide on seal wire 1604.Delivery catheter 2208 and filament insert Connector 2210 between 2200 can be melted by electric smelting.In use, when suitable electric current by when, connector 2210 is broken.
Figure 22 E and Figure 22 F show the filament insert 2200 in the use according to an embodiment.Filament insert 2200 deliver via delivery catheter 2212 and guiding catheter 1600.Seal wire 1604 can also be used for assisted delivery.Delivery catheter 2212 It can be any of above-mentioned delivery catheter.Once filament insert 2200 is placed in Eustachian tube ET, its can is being held Delivered substance in the continuous period.Filament insert 2200 can be stayed in for good and all in Eustachian tube ET, or is removed later.
As it was previously stated, described in any implantable embodiment such as, but not limited to Figure 21 and Figure 22 described herein Those optionally include being used to implant being anchored at one or more of Eustachian tube or nasal cavity anchorage element.Such anchoring Component helps prevent implant unnecessarily to migrate out Eustachian tube, and may include such as suture loop, barb or fixture.
In various alternative embodiments, it may include any of many different endoscopes, as the above method and A part for system.For example, peeped in standard ENT endoscopes-zero degree endoscope can be used in some embodiments, be at an angle of Mirror or combination.In another embodiment, variable visual angle endoscope, such as swing prism endoscope can be used. In further embodiment, soft endoscope can be used, such as optical fiber or CMOS check mirror.
In some embodiments, endoscope could attach to or be incorporated to dilating catheter (or other treatment conduits) or leads Pipe.Figure 23 A to Figure 23 C show to be attached to two embodiments of the endoscope of guiding catheter.Figure 23 A show to be arranged on nasal cavity NC In guiding catheter 2300, its distal end is located near Eustachian tube ET.Guiding catheter 2300 includes the endoscope being mounted laterally Path 2302, endoscope such as flexible fiber check that mirror can be promoted by endoscope path 2302 or forever placed.Figure 23 B are to draw The cross sectional end view of conduit 2300, it includes instrument path 2304 and endoscope path 2302.Endoscope path 2302 can It is included in the optical fiber (or alternatively, chip) in core 2306 and the illumination fiber in exterior section 2308, or Vice versa.Figure 23 C are the sectional views of the alternative embodiment of guiding catheter 2310, and guiding catheter 2310 also has apparatus path 2312, but there are two side paths in addition, the side path includes the first path 2314, Yi Jiyong for optical fiber or chip In the alternate path 2316 (or vice versa as the same) of illumination fiber.In various embodiments, any suitable of path can be used Combination and placement.In an alternative embodiment, the wall of guiding catheter can be embedded into by illuminating fiber and/or boroscope In.
Figure 24 A to Figure 24 C show two alternative embodiments, and wherein endoscope is incorporated in foley's tube.Such as Figure 24 A institutes Show, foley's tube 2400 generally may include axle 2402 and sacculus 2404.Figure 24 B show foley's tube 2400 from the line in Figure 24 A The cross section of A-A perspectives.In this embodiment, outer shroud is sacculus 2404, and middle ring 2406 illuminates fiber and extended there through Path, and inner circle 2408 is to visualize the path that fiber or chip extend there through.In the alternative embodiment shown in Figure 24 C In, foley's tube 2410 may include the outer balloon 2414 around the path 2416 for passing through illumination fiber.In path 2416 Ductility supporting member 2418 (line etc.) also be present and visualize the inner gateway 2412 that fiber or chip extend there through.Each In kind embodiment, any combinations and the configuration of path can be used.
In another alternative embodiment (not shown), sheath can be used to be peeped with interior for any one in equipment as described herein Mirror couples, and some in sheath are known in the art, and some of which can be invented in future.Sheath can be disposable , and a part for any suitable endoscope can be covered, the standard endoscope such as, but not limited to used by ENT doctor, Variable visual angle endoscope, it is at an angle of and checks mirror etc..Sheath can coordinate on endoscope (or part of endoscope), and wrap Include side path, one or more working equipment guiding catheters, sacculus dilating catheter, other treatment conduits or diagnostic catheter etc. It may pass through the side path.
With reference now to Figure 25, in one embodiment, Eustachian tube, which enters guiding piece 2500, may include hub portion 2502, nearside Shaft portion 2510 and distal shaft part 2512.Hub portion 2502 can include retainer 2504 in proximal end, be aspirated for connecting The suction orifice 2506 of source such as suction tube (not shown) and the finger for passing through the application suction of equipment 2500 using finger Hole 2508.Distal shaft part 2512 may include bending section 2516 and distal end 2514.In one embodiment, Eustachian tube enters Enter guiding piece 2500 can be similar to Relieva Flex.TM. nasal sinus guiding catheter (Acclarent, Inc., Menlo Park, Calif.) configure and/or manufacture.
Can have any suitable length, diameter and angle of bend into guiding piece 2500.For example, in various embodiments In, can have into guiding piece 2500 between about 0 degree and about between 180 degree, and more preferably between about 30 degree and about 90 degree Between angle.Proximal shaft segment 2510 can be made up of hypotube, and distal shaft part 2512 can be made up of nylon, and at one In embodiment, distal end 2514 can be made up of nylon elastomer.In various embodiments, distal part 2512 can be between Between about 4cm and about 8cm, more preferably about 6cm, and portions of proximal 2510 can be between about 5cm and about 15cm, more preferably Ground is between about 8cm and about 12cm.
With reference now to Figure 26, the sacculus dilating catheter 2600 for expanding Eustachian tube may include closely in some embodiments Side hub portion 2602, nearside hub portion 2602 include finger support 2603, axle 2604 and sacculus 2606.Sacculus dilating catheter 2600 can have Many and Relieva Solo Pro.TM nasal sinus foley's tubes or Relieva Solo.TM. nasal sinus foley's tubes (Acclarent, Inc., Menlo Park, Calif.) identical feature, size and other properties.In some embodiments, One or more features, size of such conduit etc. are changed in order to use foley's tube 2600 in Eustachian tube.
With reference now to Figure 27, in one embodiment, the system for expanding Eustachian tube 2700 may include to guide equipment 2710 and sacculus dilating catheter 2720.Equipment 2710 is guided to have in the feature or characteristic on the embodiment above discussion Any one.In addition, guiding equipment 2710 may include the shank 2712 with finger support 2714.Shank 2710 can be with the coupling of axle 2716 Connect, and foley's tube 2720 may pass through shank 2712 and axle 2716.
With reference now to Figure 28 A to Figure 28 D, in one embodiment, for expanding the sacculus dilating catheter of Eustachian tube 2800 (Figure 28 A) can be with being used together with bent portion 2812 with the stylet 2810 (Figure 28 B) of shank 2814.Such as Figure 28 C Shown, when stylet 2810 is advanced in foley's tube 2800, there is stylet 2810 enough rigidity to keep approaching Its original shape, so as to which the curve of bent portion 2812 is imparted on foley's tube 2800.As shown in fig. 28d, stylet is worked as 2810 bent portion 2812 rotates the distal part of foley's tube 2800 in the other directions, by rotating shank 2814, Foley's tube 2800 can turn to.This is only an example of the mode that foley's tube 2800 can turn in various embodiments.
In another embodiment, and with reference now to Figure 29 A and Figure 29 B, balloon expandable equipment 2900 may include to stretch Contracting axle 2902 and inflatable balloon portion 2904.As shown in figure 29 a, in one configuration, telescopic shaft 2902 can be extended to incite somebody to action Balloon portion 2904 is advanced in Eustachian tube.As shown in fig. 29b, in another configuration, telescopic shaft 2902 can be shortened to return Contracting balloon portion 2904 and/or for equipment 2900 to be initially advanced in nasal cavity.The embodiment is only that expansion device can quilt It is advanced in nasal cavity and is then advanced in Eustachian tube an example in a manner of expanding Eustachian tube.
This paper various examples include the inflation dependent on sacculus, and to provide Eustachian tube ET, (or some other dissections are logical Road) expansion expansion apparatus.It will be appreciated, however, that the apparatuses of various other species can be used to provide Eustachian tube ET (or one A little other anatomical passageway) expansion.Such apparatus that substitutes can be dependent on the mechanical swelling of mechanism, so as to provide supplement or replace according to Rely in the expansion of the inflation of sacculus or other inflatable components, to provide expansion.Only by way of example, mechanical expansion can root According to entitled " the Mechanical Dilation of the Ostia of Paranasal submitted on March 16th, 2015 Sinuses and Other Passageways of the Ear, Nose and Throat " U.S. Patent application 14/ At least some in 658,432 teachings are provided, and the disclosure of which is herein incorporated by reference.With reference to this The teachings of text, it is possible to provide other suitable modes of mechanical expansion will be for those of ordinary skills it is aobvious and It is clear to.
Figure 30 to Figure 31 shows that the exemplary seal wire 50 that above-mentioned code uses can be combined.Seal wire 50 includes surrounding cored wire 54 The coil 52 of positioning.Inside of the fiber 56 along cored wire 54 is illuminated to extend and terminate in hurtless measure lens 58.In seal wire 50 Connector 55 at proximal end makes being capable of optics coupling between illumination fiber 56 and light source.Can be included by illuminating fiber 56 by one Or multiple optical fibers.Lens 58 are configured to the projection light when illuminating fiber 56 and being illuminated by light source so that illumination fiber 56 will Light is transferred to lens 58 from light source.In some patterns, the distal end of seal wire 50 is more more flexible than the proximal end of seal wire 50. Only by way of example, seal wire 50 can configure according at least some in the teachings of U.S. Publication 2012/0078118, The disclosure of which is herein incorporated by reference.In some patterns, seal wire 50 is configured similarly to Acclarent The Relieva Luma Sentry of company (Menlo Park, California)TMNasal sinus illuminator.With reference to teaching herein Content, the adoptable other suitable forms of seal wire 50 will be apparent for the ordinary skill in the art.
In some cases, particularly prevent seal wire 50 can by the isthmus to Eustachian tube ET when entering Eustachian tube ET To be beneficial, so as to prevent seal wire 50 from entering middle ear 14 and potentially cause infringement.This can be by shown in Figure 32 to Figure 33 Exemplary alternative seal wire 51 solves.Seal wire 51 is similar to seal wire 50 in every respect in addition to adding distal end 9700. The size of distal end 9700 before seal wire 51 is advanced further into middle ear 14 to make the side that seal wire 51 stops at isthmus Formula designs.In this example, the external diameter of distal end 9700 is about 2mm.Alternatively, any other suitable external diameter can be used. Distal end 9700 includes path 9702, to allow the optical illumination Eustachian tube ET projected by lens 58.Shone by path 9702 The light being mapped in Eustachian tube ET can be used as the instruction that Eustachian tube ET fully expanded by the transillumination of eardrum.In addition or Alternatively, distal end 9700 can be by the material 9701 with light transmission properties (for example, transparent or semitransparent plastics or glass Glass etc.) it is made so that when light is by illuminating fiber 56 and the transmission of lens 58, material 9701 can illuminate itself.
In any one in method described herein, operator can pierce through or penetrate first eardrum 22, so as in Ear 14 provides the temporary ventilation path by duct 20.For example, before expander is inserted in Eustachian tube ET 26, operator Pin (for example, as shown in Figure 4) or other puncture apparatuses can be driven through ear-drum 22.Alternatively, operator can be first by expansion In device insertion Eustachian tube ET26, then ear-drum 22 is pierced through before expander is expanded.Under any circumstance, the shape of ear-drum 22 is passed through Into opening can be sufficiently large, to allow air to be roused between the mid-terms of expander insertion Eustachian tube ET 26 and/or in expander in pharynx Escaped during being expanded in pipe ET 26 via duct 20 from middle ear 14.However, the opening formed by ear-drum 22 can be sufficiently small, make Must be open itself to heal, and does not need any kind of adhesive or suture etc. after expansion operation is completed.With reference to this The teachings of text, before expander is inserted in Eustachian tube ET 26 or expander expanded in Eustachian tube ET26 before can The various suitable methods for piercing through ear-drum 22 will be apparent for those of ordinary skills.
Without departing from the essential characteristics of the invention, the present invention can be realized with other concrete forms.These its Its embodiment is intended to be included in the scope of the present invention illustrated by following claims.

Claims (20)

1. one kind expansion device assembly, including：
(a) axle, the axis limit longitudinal axis, wherein the axle includes：
(i) distal end,
(ii) proximal end, and
(iii) at least one shaft lumen；
(b) expandable stent, the expandable stent is located on the axle, wherein the expandable stent is positioned at Between the distal end of the axle and the proximal end of the axle, wherein the expandable stent includes being configured Into the main body changed between contraction state and swelling state, wherein the main body is configured to expand under the swelling state The Eustachian tube of patient, wherein the main body also includes distal end and proximal end；And
(c) at least one ventilation path, the ventilation path are configured to provide when the main body is in the swelling state The ventilation of the proximal end from the distal end of the main body to the main body, wherein at least one vent passage Footpath includes one or both of the following：
(i) vent openings of the one group of horizontal orientation formed by the axle, wherein at least one vent openings are located at the master The distal side of the distal end of body, and at least one other vent openings are located at the near of the proximal end of the main body Side, or
(ii) space, the structure qualification that the space is projected radially outwardly by the one or more of the expandable stent.
2. expansion device assembly according to claim 1, wherein the main body includes conical by its shape, wherein the conical by its shape It is configured to complementary with the taper geometry of Eustachian tube.
3. expansion device assembly according to claim 1, wherein the shaft lumen is in fluid communication with the vent openings.
4. expansion device assembly according to claim 1, wherein the expander has stairstepping.
5. expansion device assembly according to claim 1, wherein one or more outstanding described structures include recessed The lug boss of the separated multiple Longitudinal extendings in the portion of falling into.
6. expansion device assembly according to claim 5, wherein the lug boss is configured to the wall against Eustachian tube, and institute Depressed part is stated to be configured to limit the space that the ventilation path is provided.
7. expansion device assembly according to claim 6, wherein the lug boss around the axle the longitudinal axis into Angle equally spaced from each other sow discord separate.
8. expansion device assembly according to claim 1, wherein one or more of outstanding structures include surrounding Multiple flanks that the longitudinal axis of the axle angularly extends, wherein the flank is longitudinally spaced apart from each other.
9. expansion device assembly according to claim 8, wherein the main body also include being positioned at it is more between the flank Individual annular recess so that it is longitudinally spaced that the annular recess provides being spaced apart for the flank.
10. expansion device assembly according to claim 8, wherein the main body also includes multiple longitudinal directions across the flank Depressed part.
11. expansion device assembly according to claim 1, wherein one or more of outstanding structures are included from institute State multiple discrete lugs that main body extends radially outwardly.
12. expansion device assembly according to claim 11, wherein the discrete lugs surround the longitudinal axis of the axle Line and the array positioning along the length of the main body to be angularly positioned.
13. expansion device assembly according to claim 1, wherein one or more of outstanding structures are included along institute State the spiral rib of main body spirality extension.
14. expansion device assembly according to claim 1, wherein one or more of outstanding structures are included along institute State the fin of the length extension of main body.
15. expansion device assembly according to claim 1, in addition to breather pipe, wherein the breather pipe is adjacent to the main body Perimeter positioning, wherein the breather pipe along parallel to the axle the longitudinal axis axis extend.
16. expansion device assembly according to claim 1, wherein the expander is configured to mechanical swelling, without Inflation.
17. a kind of method for being used to expand the Eustachian tube of patient, methods described include：
(a) expander including distal end and proximal end is promoted into the nasal passage by the patient, by the expansion At least described distal end of prop is positioned in the Eustachian tube of the patient；
(c) distal end of the expander is made to expand to expand a part for the Eustachian tube, while the expander The proximal end keep it is unexpanded；
(d) expand the proximal end of the expander after the distal end of the expander is expanded To expand a part for the Eustachian tube, while the distal end of the expander keeps expansion；
(e) expander is made to collapse；And
(f) expansion device is removed from the patient's body.
18. the method according to claim 11, in addition to the Eustachian tube on the head of the puncture patient will be expanded Side on ear-drum, performed wherein piercing through the action of the ear-drum before the action of the expander is promoted.
19. a kind of seal wire, including：
(a) main body, the main body, which has, to be enough the nasal cavity for extending through the patient in vitro from patient and extends to Length in the Eustachian tube of the patient；And
(b) flexible distal end sections, the flexible distal end sections include：
(i) there is the coil of first external diameter, and
(ii) there is the end of second external diameter, wherein the second external diameter is more than the external diameter of the coil, wherein the end The second external diameter at end is sufficiently small so that the end coordinates in Eustachian tube, wherein the second external diameter foot of the end Enough greatly to prevent the end from coordinating in the isthmus of Eustachian tube, so as to prevent during the end from inserting in lug areas；And
(c) at least one optical fiber of the main body is extended through, wherein at least one optical fiber is configured to pass Send light；
Wherein described end is configured to conveying from the light of optical fiber transmission.
20. seal wire according to claim 19, wherein the end includes one or both of the following：
(i) it is configured to provide the hole in the path for being used to transmit the light from the optical fiber, or
(ii) it is configured to transmit the material with light transmission properties of the light from the optical fiber.
CN201680031186.4A 2015-03-31 2016-03-30 Eustachian tube dilating sacculus with ventilation path Pending CN107847713A (en)

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US14/674,639 US10206821B2 (en) 2007-12-20 2015-03-31 Eustachian tube dilation balloon with ventilation path
US14/674639 2015-03-31
PCT/US2016/024978 WO2016160967A1 (en) 2015-03-31 2016-03-30 Eustachian tube dilation balloon with ventilation path

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WO2016160967A1 (en) 2016-10-06
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KR20170133422A (en) 2017-12-05

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