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WO2010059586A1 - Appareils et procédés de correction de l'effondrement de la valve nasale - Google Patents

Appareils et procédés de correction de l'effondrement de la valve nasale Download PDF

Info

Publication number
WO2010059586A1
WO2010059586A1 PCT/US2009/064689 US2009064689W WO2010059586A1 WO 2010059586 A1 WO2010059586 A1 WO 2010059586A1 US 2009064689 W US2009064689 W US 2009064689W WO 2010059586 A1 WO2010059586 A1 WO 2010059586A1
Authority
WO
WIPO (PCT)
Prior art keywords
body portion
upper lateral
head portion
lateral cartilage
barbs
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2009/064689
Other languages
English (en)
Inventor
Donald Gonzales
Christopher Revell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arthrocare Corp
Original Assignee
Entrigue Surgical Inc
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 Entrigue Surgical Inc filed Critical Entrigue Surgical Inc
Priority to US13/129,846 priority Critical patent/US9597220B2/en
Publication of WO2010059586A1 publication Critical patent/WO2010059586A1/fr
Anticipated expiration legal-status Critical
Priority to US15/423,345 priority patent/US10786383B2/en
Priority to US17/005,087 priority patent/US11806265B2/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
    • A61F5/08—Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2/186—Nose parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0646—Surgical staples, i.e. penetrating the tissue for insertion into cartillege, e.g. meniscus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks

Definitions

  • the present disclosure relates generally to devices, systems and methods for correcting a nasal valve collapse and/or stabilizing lateral nasal cartilage.
  • Nasal valve collapse is a frequent and sufficient cause of nasal airway obstruction, characterized by a loss of support from lateral nasal cartilages typically observed following rhinoplasty, nasal trauma or in aged patients.
  • Properly functioning nasal cartilage acts to keep the nasal passages open. If the lateral cartilages become weak, they collapse inward when a person inhales due to the negative pressure from the flow of air. This problem is currently largely untreated due to the complexity and highly variable results associated with current repair techniques, combined with the fact that a majority of patients are elderly or have a history of nasal surgery. These complex surgical procedures have been developed to correct valve collapse by reinforcing the lateral cartilages so adequate support can permit valve opening and thus eliminate the nasal airway obstruction.
  • Results of these procedures have been highly variable and drawbacks include the lack of sufficient autologous grafting tissue, significant infection and extrusion of synthetic grafts, the potential for altering facial aesthetics and possible confounding effects on other nasal functionality.
  • Another method for repairing nasal valve collapse developed by Friedman et al., involves a bone-anchor suspension technique whereby a suture is anchored to the orbital rim and placed subcutaneously so as to loop through the upper lateral cartilage. Instead of imparting structural integrity to the collapsed cartilage, it applies tensile forces through this suture to prevent further collapse.
  • the procedure has shown some promise, very few surgeons perform the technique because of the technical difficulties and potential complications. Complications occur because patients develop granulomas due to suture proximity to the nasal mucosa, which eventually necessitates implant removal.
  • nasal valve collapse is an oftentimes untreated problem due to inconsistent results from a myriad of very complex procedures performed by very few surgeons. As such, there remains a need for an endoscopic method to repair nasal valve in a simple, consistent manner.
  • Exemplary embodiments of the present disclosure comprise a device configured for suspending a nasal valve.
  • the device comprises a body portion comprising a proximal end, a distal end, and a plurality of barbs.
  • the body portion can be configured to be inserted through or underneath the upper lateral cartilage of a patient and the plurality of barbs configured to engage the soft tissue overlying bony tissue proximal to the upper lateral cartilage.
  • Certain embodiments may comprise a head portion coupled to the proximal end of the body portion, where the head portion is configured to engage the upper lateral cartilage of the patient when the plurality of barbs are engaged with the soft tissue overlying bony tissue proximal to the upper lateral cartilage.
  • the head portion is coupled to the body portion to form a "T" shape, while in other embodiments the head portion is coupled to the body portion to form an "L" shape or a hook shape.
  • the plurality of barbs can be distributed along one side of the body portion and may be directed toward the proximal end of the body portion.
  • the body portion and head portion are separated by an angle of between 90 and 120 degrees, more specifically between 95 and 115 degrees, and more specifically still between 100 and 110 degrees.
  • the body portion and head portion are separated by an angle of between 60 and 20 degrees, more specifically between 55 and 25 degrees, and more specifically still between 50 and 30 degrees.
  • inventions comprise a method of stabilizing the upper lateral cartilage of a patient.
  • the method may comprise: creating an aperture in the mucosa of the patient; inserting a device with a body portion and a head portion into the aperture, where the body portion of the device is inserted into the aperture prior to the head portion; advancing the device into the aperture so that the head portion engages the upper lateral cartilage of the patient; and engaging the plurality of barbs into soft tissue overlying the bony tissue proximal to the upper lateral cartilage.
  • Specific embodiments may include engaging the plurality of barbs into soft tissue overlying the bony tissue lateral to the upper lateral cartilage, including, for example, the maxilla of the patient.
  • the body portion of the device pierces the upper lateral cartilage of the patient, and in other embodiments the body portion of the device is inserted between the upper lateral cartilage of the patient and bony tissue proximal to the upper lateral cartilage. In specific embodiments, the device is inserted into the aperture using a guiding needle sheath.
  • engaging the plurality of barbs into the soft tissue overlying the bony tissue proximal to the upper lateral cartilage of the patient comprises pressing down on an epidermal tissue proximal to the device.
  • the soft tissue overlying the bony tissue is part of the orbital bone, while in other embodiments, the bony tissue is part of the nasal bone.
  • FIG. 1 illustrates a perspective view of a nasal valve suspension device according to an exemplary embodiment of the present disclosure.
  • FIG. 2 illustrates a perspective view of the embodiment of FIG. 1 in an exemplary installed position.
  • FIG. 3 illustrates a perspective view of a nasal valve suspension device according to an exemplary embodiment of the present disclosure.
  • FIG. 4 illustrates a perspective view of the embodiment of FIG. 2 in an exemplary installed position.
  • FIG. 5 illustrates side and top views of a nasal valve suspension device according to an exemplary embodiment of the present disclosure.
  • FIG. 6 illustrates side and top views of a nasal valve suspension device according to an exemplary embodiment of the present disclosure.
  • FIG. 7 illustrates a front view of the embodiment of FIG. 5 in an exemplary installed position.
  • FIG. 8 illustrates a side view of the embodiment of FIG. 5 in an exemplary installed position.
  • a nasal valve suspension device (NVSD) 100 is configured in a "T"-shape comprising a head portion 110 and a body portion 120 having a proximal end 122 and a distal end 124.
  • a plurality of barbs 130 are disposed along body portion 120 so that the pointed ends of each barb are directed towards proximal end 122 (and head portion 110) and away from distal end 124.
  • body portion 120 may be 0.5 to 3.0 cm in length
  • head portion 110 may be approximately 0.5 centimeters in length.
  • NVSD 100 intranasal endoscopic placement of NVSD 100 may be employed to allow NVSD 100 to support the nasal cartilage and prevent collapse of the nasal valve.
  • NVSD 100 may comprise a non- bioabsorbable material.
  • NVSD 100 may comprise a bioabsorbable material. Based on the material used to construct NVSD 100, the device can provide structural support while new tissue attachments are formed, and NVSD 100 may remain or degrade over time.
  • NVSD 100 may be installed in an intranasal method by forming a slit or aperture 170 in the mucosa of a patient.
  • Aperture 170 should be sized large enough to allow NVSD 100, including head portion 110, to pass through aperture 170.
  • NVSD 100 can be inserted through aperture 170 so that body portion 120 is first inserted and head portion 110 follows.
  • NVSD 100 is oriented so that barbs 130 are facing down (e.g. towards the bone underlying the upper lateral cartilage and away from the epidermis).
  • Body portion 120 can then be advanced to penetrate the upper lateral cartilage of the patient until head portion 110 engages the upper lateral cartilage.
  • NVSD 100 can then be further advanced until head portion 110 exerts the desired amount of tension on the upper lateral cartilage.
  • the surgeon can press down on the epidermis above NVSD 100 so that barbs 130 engage the periosteum of the bone tissue lying lateral to the upper lateral cartilage (e.g., the orbital bone).
  • barbs 130 will remain engaged with the periosteum and will maintain the position of NVSD 100.
  • Head portion 110 of NVSD 100 will continue to maintain a force exerted on the upper lateral cartilage and will stabilize the lateral cartilage (e.g., restrict the upper lateral cartilage from deflecting inwards) when the patient inhales.
  • NVSD 200 comprises a head portion 210 and a body portion 220 having a proximal end 222 and a distal end 224. Head portion 210 and body portion 220 are spaced apart from each other at an angle 215. In certain embodiments, angle 215 is between approximately 60 degrees and 20 degrees. In specific embodiments, angle 215 is between 55 degrees and 25 degrees, and in more specific embodiments angle 215 is between 50 and 40 degrees.
  • a plurality of barbs 230 are disposed along body portion 220 so that the pointed ends of each barb are directed towards proximal end 222 (and head portion 210) and away from distal end 224.
  • this embodiment can be installed through a mucosal aperture 270 so that NVSD 200 either penetrates or is placed above the superior aspect of the upper lateral cartilage.
  • NVSD 200 can be installed so that body portion 220 is inserted first and barbs 230 are facing towards the bony tissue of the nasal bone.
  • the surgeon can advance NVSD 200 so that head portion 210 engages the upper lateral cartilage.
  • the surgeon can press down on the epidermis above NVSD 200 so that barbs 230 engage the periosteum of the bone tissue below.
  • Both NVSD 200 and NVSD 300 may be installed in either of the positions shown in FIGS. 2 and 4.
  • NVSD 300 comprises a head portion 310, a body portion 320 having a proximal end 322 and a distal end 324. Head portion 310 and body portion 320 are spaced apart from each other at an angle 315. In certain embodiments, angle 315 is between approximately 90 degrees and 120 degrees. In specific embodiments, angle 315 is between 95 degrees and 115 degrees, and in more specific embodiments angle 315 is between 100 and 110 degrees.
  • a plurality of barbs 330 are disposed along body portion 320 so that the pointed ends of each barb are directed towards proximal end 322 (and head portion 310) and away from distal end 324.
  • FIG. 6 another exemplary embodiment of an NVSD is similar to that shown in FIG. 5, but comprises a head portion 410 that is slightly curved.
  • NVSD 400 comprises head portion 410, a body portion 420 having a proximal end 422 and a distal end 424. Head portion 410 and body portion 420 are spaced apart from each other at an angle 415.
  • a plurality of barbs 430 are disposed along body portion 420 so that the pointed ends of each barb are directed towards proximal end 422 (and head portion 410) and away from distal end 424.
  • the embodiment in FIG. 6 can be installed in the same manner as the embodiment of FIG. 5, described below.
  • NVSD 300 can be installed so that body portion 320 is installed through an aperture 570 in upper lateral cartilage 501. Also visible in
  • FIGS. 7 and 8 are lower lateral cartilage 502 and accessory cartilage 503.
  • Head portion 310 does not extend through aperture 570, but instead remains under upper lateral cartilage 501.
  • Body portion 320 is inserted through aperture 570 sufficiently for head portion 310 to engage upper cartilage 501.
  • body portion 320 is oriented so that barbs 330 are facing towards the bone tissue proximal to body portion 320. Similar to previous embodiments, the surgeon can press down on the epidermis above NVSD 300 so that barbs 330 engage the periosteum of the bone tissue lying lateral to the upper lateral cartilage 501 (e.g., the orbital bone).
  • NVSD 300 When the surgeon releases the pressure exerted on NVSD 300, barbs 330 will remain engaged with the periosteum and will maintain the position of NVSD 300. Head portion 310 of NVSD 300 will continue to maintain a force exerted on upper lateral cartilage 501 and will restrict upper lateral cartilage 501 from deflecting inwards when the patient inhales. Angle 315 between head portion 310 and body portion 320 is configured so that head portion 310 maintains a sufficient force on upper lateral cartilage 501 to restrict deflection during inhalation.
  • exemplary embodiments of this disclosure can be implemented to support nasal cartilage and keep the nasal passages open, particularly during inhalation.
  • Exemplary embodiments utilize barbs that engage the periosteum of bone tissue proximal to the nasal cartilage and serve to maintain the device in the desired position.
  • Exemplary devices also comprise a portion that engages the nasal cartilage and exerts a force against it that resists the collapse of the cartilage.
  • Claims or descriptions that include "or" between one or more members of a group are considered satisfied if one, more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process unless indicated to the contrary or otherwise evident from the context.
  • the invention includes embodiments in which exactly one member of the group is present in, employed in, or otherwise relevant to a given product or process.
  • the invention also includes embodiments in which more than one, or all of the group members are present in, employed in, or otherwise relevant to a given product or process.
  • embodiments of the invention encompasses compositions made according to any of the methods for preparing compositions disclosed herein. Where elements are presented as lists, e.g., in Markush group format, it is to be understood that each subgroup of the elements is also disclosed, and any element(s) can be removed from the group. It is also noted that the term "comprising" is intended to be open and permits the inclusion of additional elements or steps. It should be understood that, in general, where the invention, or aspects of the invention, is/are referred to as comprising particular elements, features, steps, etc., certain embodiments of the invention or aspects of the invention consist, or consist essentially of, such elements, features, steps, etc.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Nursing (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne des appareils et des procédés de correction de l'effondrement de la valve nasale, et comprend un dispositif configuré pour suspendre une valve nasale, le dispositif comprenant une partie de corps qui contient une extrémité proximale, une extrémité distale et plusieurs barbes, la partie de corps étant configurée pour être insérée à travers ou en dessous du cartilage latéral supérieur du patient, les différentes barbes étant configurées de manière à entrer en prise avec un tissu mou qui surmonte le tissu osseux à proximité du cartilage latéral supérieur, et une partie de tête reliée à l'extrémité proximale de la partie de corps, la partie de tête étant configurée pour entrer en prise avec le cartilage latéral supérieur du patient lorsque les différentes barbes sont en prise avec le tissu mou qui recouvre le tissu osseux à proximité du cartilage latéral supérieur.
PCT/US2009/064689 2008-11-19 2009-11-17 Appareils et procédés de correction de l'effondrement de la valve nasale Ceased WO2010059586A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US13/129,846 US9597220B2 (en) 2008-11-19 2009-11-17 Apparatus and methods for correcting nasal valve collapse
US15/423,345 US10786383B2 (en) 2008-11-19 2017-02-02 Apparatus and methods for correcting nasal valve collapse
US17/005,087 US11806265B2 (en) 2008-11-19 2020-08-27 Apparatus and methods for correcting nasal valve collapse

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11611208P 2008-11-19 2008-11-19
US61/116,112 2008-11-19

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US13/129,846 A-371-Of-International US9597220B2 (en) 2008-11-19 2009-11-17 Apparatus and methods for correcting nasal valve collapse
US15/423,345 Continuation US10786383B2 (en) 2008-11-19 2017-02-02 Apparatus and methods for correcting nasal valve collapse

Publications (1)

Publication Number Publication Date
WO2010059586A1 true WO2010059586A1 (fr) 2010-05-27

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PCT/US2009/064689 Ceased WO2010059586A1 (fr) 2008-11-19 2009-11-17 Appareils et procédés de correction de l'effondrement de la valve nasale

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US (3) US9597220B2 (fr)
WO (1) WO2010059586A1 (fr)

Cited By (8)

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DE102012107123A1 (de) * 2012-08-03 2014-02-06 Heinz Kurz Gmbh Medizintechnik Septum-Implantat
US20140243975A1 (en) * 2013-02-27 2014-08-28 Iyad S. SAIDI Nasal implants and systems and methods of use
US9597220B2 (en) 2008-11-19 2017-03-21 Spirox, Inc. Apparatus and methods for correcting nasal valve collapse
US10398545B2 (en) 2014-08-26 2019-09-03 Spirox, Inc. Nasal implants and systems and method of use
US10987133B2 (en) 2016-05-02 2021-04-27 Entellus Medical, Inc. Nasal valve implants and methods of implanting the same
US10993800B2 (en) 2015-09-25 2021-05-04 Spirox, Inc. Nasal implants and systems and method of use
EP4164550A4 (fr) * 2020-06-10 2024-06-19 The Board of Trustees of the Leland Stanford Junior University Systèmes et procédés pour modifier la forme de tissus nasaux
US12357493B2 (en) 2022-12-09 2025-07-15 Spirair, Inc. Devices, systems, and methods for manipulating nasal tissues

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US7780730B2 (en) 2006-09-25 2010-08-24 Iyad Saidi Nasal implant introduced through a non-surgical injection technique
CN109715056B (zh) * 2016-09-16 2022-12-13 斯派洛克斯公司 诊断工具和使用方法
WO2018132159A2 (fr) * 2016-11-03 2018-07-19 Spirox, Inc. Implants nasaux minimalement invasifs et systèmes et procédés associés
CN106473838A (zh) * 2016-12-08 2017-03-08 大连裕辰科技发展有限公司 一种用于鼻部整形填充自体骨联合钛支架的材料及其制备方法
CN110225732A (zh) * 2016-12-30 2019-09-10 斯贝洛克斯公司 鼻部植入物和使用方法
EP4574065A3 (fr) 2017-03-28 2025-08-20 Stryker Corporation Outils d'administration nasale
WO2018191659A1 (fr) * 2017-04-13 2018-10-18 Spirox, Inc. Implants nasaux, outils de mise en place, systèmes et procédés d'utilisation
US11554027B2 (en) 2018-09-10 2023-01-17 Siesta Medical, Inc. Systems and methods for nasal support
US11135083B2 (en) * 2018-11-30 2021-10-05 David G. Dillard Barbed nasal implant and method for adjustable repair and re-positioning of the nasal valve ligament
US20240041591A1 (en) * 2021-11-09 2024-02-08 Hae Seok OH Lifting suture for rhinoplasty and manufacturing method thereof

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US11806265B2 (en) 2023-11-07
US10786383B2 (en) 2020-09-29

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