WO2003022192B1 - Eustachian tube stent - Google Patents

Eustachian tube stent

Info

Publication number
WO2003022192B1
WO2003022192B1 PCT/US2002/030254 US0230254W WO03022192B1 WO 2003022192 B1 WO2003022192 B1 WO 2003022192B1 US 0230254 W US0230254 W US 0230254W WO 03022192 B1 WO03022192 B1 WO 03022192B1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular body
hollow tubular
eustachian tube
stent
proximal end
Prior art date
Application number
PCT/US2002/030254
Other languages
French (fr)
Other versions
WO2003022192A1 (en
Inventor
Jason Litner
Original Assignee
Jason Litner
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jason Litner filed Critical Jason Litner
Priority to CA2460222A priority Critical patent/CA2460222C/en
Priority to MXPA04002429A priority patent/MXPA04002429A/en
Priority to JP2003526324A priority patent/JP4249617B2/en
Priority to DE60234939T priority patent/DE60234939D1/en
Priority to EP02773549A priority patent/EP1424971B1/en
Publication of WO2003022192A1 publication Critical patent/WO2003022192A1/en
Publication of WO2003022192B1 publication Critical patent/WO2003022192B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

A Eustachian tube stent designed to maintain patency of the eustachian tube passage, comprising a flanged tubular body constructed of a biodegradable material capable of eluting a drug. The stent design is adapted specifically for the Eustachian tube environment. The stent is positioned in the Eustachian tube via the middle ear by insertion past the tympanic membrane. The flange secures the stent at the tympanic orifice of the Eustachian tube.

Claims

AMENDED CLAIMS
[received by the International Bureau on 13 March 2003 (13.03.2003); original claims 1-3 and 10-13 amedned; remaining claims unchanged (4 pages)]
1. A stent (10) for placement in an Eustachian tube to maintain patency of the Eustachian tube comprising:
(c) a hollow tubular body (11) having a proximal end (12) and a distal end (13), the hollow tubular body (12) comprising a compressible core (11, 18) that can extend along the Eustachian tube less than the full length of the Eustachian tube;
(d) the compressible core having two parallel arms connected by flexible connecting elements and
(c) a radially-oriented flange (14) extending laterally from the proximal end (12) of the core.
2. A stent (10) for placement in an Eustachian tube to maintain patency of the Eustachian tube of a human comprising:
(a) a hollow tubular body (11) having a proximal end (12) and a distal end (13), the hollow tubular body comprising a pair of parallel arms that can extend along the Eustachian tube for less than the full length of the Eustachian tube
(b) a radially-oriented flange (14) extending laterally from the proximal end (12) of each arm
(c) connecting elements between the parallel arms at at least two positions along the length of the stent (10).
3. A stent (10) for placement in an Eustachian tube to maintain patency of the Eustachian tube comprising:
(a) a hollow tubular body (11 ) having a proximal end (12) and a distal end (13), the hollow tubular body (I I) comprising a compressible core that can extend along the Eustachian tube less than the full length of the Eustachian tube;
(b) a radially-oriented flange (14) extending laterally from the proximal end (12) of the compressible core within the Eustachian tube, wherein the stent (10) further comprises: 13
(c) [the] a proximal portion (12) of said hollow tubular body being located within a bony portion of the Eustachian tube, the stent having an outer diameter of at least about 1mm up to 3 mm and a length between about 8 and 18mm;
(d) a distal portion (13) of said hollow tubular body (11) when located within a cartilaginous portion of the Eustachian tube, the hollow tubular body having an outer diameter of about 1 to 2.5mm and a length of about 8 to 12mm;
(e) the proximal (12) and distal portions (13) of said hollow tubular body connected by an intervening segment having an intermediate outer diameter between the diameters of the proximal (12) and distal portions (13) of said hollow tubular body (11), the total length of said hollow tubular body (11) being between 22 and 28mm;
(f) the proximal portion (12) of said hollow tubular body (11) having a greater outer diameter than the distal portion (13) of said hollow tubular body in order to reduce erosive forces when within the Eustachian tube;
(g) the proximal end of said hollow tubular body (11 ) having a pair of radially- oriented flanges separated by a gap at superior and inferior aspects of the proximal end of said hollow tubular body (11) in order to allow for normal middle ear mucociliary clearance;
(h) the hollow tubular body (11) comprising two parallel semi-rigid arms to allow flexibility to negotiate the Eustachian tube without causing perforation;
(i) the parallel semi-rigid arms of said hollow tubular body being oriented in a longitudinal direction when in the Eustachian tube in order to minimi∑e radial expansile forces on the Eustachian tube;
(j) the parallel semi-rigid arms of said hollow tubular body connected by staggered arching supports over the superior and inferior aspects, lending strength while permitting mucociliary clearance over lateral aspects of said hollow tubular body; and
(k) the distal portion (13) of said hollow tubular body (1 1) lacking the staggered arching supports over a most distal 3 to 5mm length of the stent (10) allowing gentle collapse of the distal portion of said hollow tubular body (11 ) during normal Eustachian tube closure in order to minimize ascending infection and noise- induced trauma, or the distal portion (13) of said hollow tubular body (11) having a semi-permeable membrane across its distal end in order to minimize ascending infection. 14
4. The stent of claim 3 in which said hollow tubular body and flanges comprise a network of fibers, each fiber being about 0.2 to 0.6mm in diameter.
5. The stent of claim 4 in which said hollow tubular body and flanges comprise a biodegradable polymer.
6. The stent of claim 5 in which at least one of said hollow tubular body and flanges contain or are coated with at least one compound selected from the group consisting of lubricants, anti-bacterial agents, anti-inflammatants, antifungal agents, drug carrying agent and anti-thrombogenic agents.
7. The stent of claim 6 in which at least one of said hollow tubular body and flanges are cross-linked to said at least one compound.
8. The stent of claim 7 wherein said at least one compound is a drug carrying agent capable of the controlled release of a drug.
9. The stent of claim 8 wherein said drug comprises a surface active agent
1 . The stent of claim 9 wherein the surface active agent comprises phosphatidylcholine.
11. The stent of claim 2 wherein the parallel arms are separated at the distal end so that radially inward pressure of 0.1 kg cm2 against the arms in the distal region will cause the arms to flex inwardly and compress.
12. The stent of claims 1, 2 or 3 wherein said hollow tubular body lacks any completely circumferential supporting structures in order to minimize radial expansile forces on the Eustachian tube.
13. A stent (10) for placement in the Eustachian tube to maintain patency of the Eustachian tube comprising: 15
(a) a hollow tubular body (11 ) having a proximal end (12) and a distal end (13), the hollow tubular body (11) comprising a compressible core having two parallel arms connected by flexible connecting elements, wherein the compressible core can extend along the Eustachian tube less than the full length of the Eustachian tube;
(b) the distal end of the stent (10) being structurally compressible; and
(c) a radially-oriented flange (14) extending laterally from the proximal end of the core.
PCT/US2002/030254 2001-09-12 2002-09-10 Eustachian tube stent WO2003022192A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2460222A CA2460222C (en) 2001-09-12 2002-09-10 Eustachian tube stent
MXPA04002429A MXPA04002429A (en) 2001-09-12 2002-09-10 Eustachian tube stent.
JP2003526324A JP4249617B2 (en) 2001-09-12 2002-09-10 Eustachian tube stent
DE60234939T DE60234939D1 (en) 2001-09-12 2002-09-10 STENT FOR THE EUSTATIC TUBE
EP02773549A EP1424971B1 (en) 2001-09-12 2002-09-10 Eustachian tube stent

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/952,569 US6589286B1 (en) 2001-09-12 2001-09-12 Eustachian tube stent
US09/952,569 2001-09-12

Publications (2)

Publication Number Publication Date
WO2003022192A1 WO2003022192A1 (en) 2003-03-20
WO2003022192B1 true WO2003022192B1 (en) 2003-05-08

Family

ID=25493035

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/030254 WO2003022192A1 (en) 2001-09-12 2002-09-10 Eustachian tube stent

Country Status (7)

Country Link
US (1) US6589286B1 (en)
EP (1) EP1424971B1 (en)
JP (1) JP4249617B2 (en)
CA (1) CA2460222C (en)
DE (1) DE60234939D1 (en)
MX (1) MXPA04002429A (en)
WO (1) WO2003022192A1 (en)

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Also Published As

Publication number Publication date
EP1424971B1 (en) 2009-12-30
DE60234939D1 (en) 2010-02-11
WO2003022192A1 (en) 2003-03-20
CA2460222A1 (en) 2003-03-20
EP1424971A1 (en) 2004-06-09
JP2005501659A (en) 2005-01-20
US6589286B1 (en) 2003-07-08
CA2460222C (en) 2010-07-06
MXPA04002429A (en) 2004-11-22
JP4249617B2 (en) 2009-04-02

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