WO2016040820A1 - Support destiné à l'apophyse unciforme aux fins d'éclairage du canal naso-frontal - Google Patents

Support destiné à l'apophyse unciforme aux fins d'éclairage du canal naso-frontal Download PDF

Info

Publication number
WO2016040820A1
WO2016040820A1 PCT/US2015/049719 US2015049719W WO2016040820A1 WO 2016040820 A1 WO2016040820 A1 WO 2016040820A1 US 2015049719 W US2015049719 W US 2015049719W WO 2016040820 A1 WO2016040820 A1 WO 2016040820A1
Authority
WO
WIPO (PCT)
Prior art keywords
dilator
dilation
longitudinal axis
elongate member
feature
Prior art date
Application number
PCT/US2015/049719
Other languages
English (en)
Inventor
Randy J. Kesten
Daniel T. Harfe
Eric Goldfarb
Original Assignee
Acclarent, 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
Priority claimed from US14/484,520 external-priority patent/US9623213B2/en
Application filed by Acclarent, Inc. filed Critical Acclarent, Inc.
Publication of WO2016040820A1 publication Critical patent/WO2016040820A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • 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. 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, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22052—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation eccentric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A61B2017/246—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers for cleaning of the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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

Definitions

  • an anatomical passageway in a patient. This may include dilation of ostia of paranasal sinuses (e.g., to treat sinusitis), dilation of the larynx, dilation of the Eustachian tube, dilation of other passageways within the ear, nose, or throat, etc.
  • One method of dilating anatomical passageways includes using a guidewire and catheter to position an inflatable balloon within the anatomical passageway, then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway.
  • a fluid e.g., saline
  • the expandable balloon may be positioned within an ostium at a paranasal sinus and then be inflated, to thereby dilate the ostium by remodeling the bone adjacent to the ostium, without requiring incision of the mucosa or removal of any bone.
  • the dilated ostium may then allow for improved drainage from and ventilation of the affected paranasal sinus.
  • a system that may be used to perform such procedures may be provided in accordance with the teachings of U.S. Pub. No. 2011/0004057, entitled “Systems and Methods for Transnasal Dilation of Passageways in the Ear, Nose or Throat," published January 6, 2011, the disclosure of which is incorporated by reference herein.
  • An example of such a system is the Relieva® Spin Balloon SinuplastyTM System by Acclarent, Inc. of Menlo Park, California.
  • a variable direction view endoscope may be used with such a system to provide visualization within the anatomical passageway (e.g., the ear, nose, throat, paranasal sinuses, etc.) to position the balloon at desired locations.
  • a variable direction view endoscope may enable viewing along a variety of transverse viewing angles without having to flex the shaft of the endoscope within the anatomical passageway.
  • Such an endoscope that may be provided in accordance with the teachings of U.S. Pub. No. 2010/0030031, entitled “Swing Prism Endoscope,” published February 4, 2010, the disclosure of which is incorporated by reference herein.
  • An example of such an endoscope is the Acclarent CyclopsTM Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, California.
  • variable direction view endoscope may be used to provide visualization within the anatomical passageway
  • This may be done using an illuminating guidewire.
  • a guidewire may be positioned within the target area and then illuminated, with light projecting from the distal end of the guidewire. This light may illuminate the adjacent tissue and thus be visible to the naked eye from outside the patient through transcutaneous illumination. For instance, when the distal end is positioned in the maxillary sinus, the light may be visible through the patient's cheek.
  • the balloon may then be advanced distally along the guidewire into position at the dilation site.
  • Such an illuminating guidewire may be provided in accordance with the teachings of U.S. Pub. No. 2012/0078118, entitled “Sinus Illumination Lightwire Device,” published March 29, 2012, the disclosure of which is incorporated by reference herein.
  • An example of such an illuminating guidewire is the Relieva Luma SentryTM Sinus Illumination System by Acclarent, Inc. of Menlo Park, California.
  • FIG. 1 depicts a side elevational view of an exemplary dilation catheter system
  • FIG. 2 depicts a side elevational view of an exemplary illuminating guidewire suitable for use with the dilation catheter system of FIG. 1;
  • FIG. 3 depicts a side cross-sectional view of the illuminating guidewire of FIG. 2;
  • FIG. 4 depicts depicts a perspective view of an exemplary endoscope suitable for use with the dilation catheter system of FIG. 1;
  • FIG. 5 depicts a side elevational view of the distal end of the endoscope of FIG. 5, showing an exemplary range of viewing angles;
  • FIG. 6 depicts a coronal cross-sectional view of a portion of a nasal cavity, showing portions of the nasal septum, middle turbinate, ethmoid bulla, uncinate process, and ostium of a maxillary sinus;
  • FIG. 7 depicts a side elevational view of an exemplary infundibular probe and dilator
  • FIG. 8A depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with the probe positioned in the infundibular space and with the dilator in a dilated state;
  • FIG. 8B depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with the uncinate process remodeled to dilate the infundibular space;
  • FIG. 9A depicts a side elevational view of an exemplary dilator device with a single sided balloon, with the balloon in a retracted and non-inflated state;
  • FIG. 9B depicts a side elevational view of the dilator device of FIG. 9A, with the balloon in an extended and inflated state;
  • FIG. 10A depicts a cross-sectional view of the dilator device of FIG. 9A, taken along line 10A-10A of FIG. 9A;
  • FIG. 10B depicts a cross-sectional view of the dilator device of FIG. 9A, taken along line 10B-10B of FIG. 9B
  • FIG. 11 depicts a side elevational view of an exemplary dilation device with an asymmetric sinus dilation balloon
  • FIG. 12 depicts a detailed side elevational view of the asymmetric sinus dilation balloon of FIG. 11, with the balloon in a non-inflated state;
  • FIG. 13 depicts a detailed side elevational view of the distal end of the dilation device of FIG. 11, with the balloon in a distally positioned and inflated state;
  • FIG. 14 depicts a cross-sectional view of the dilation device of FIG. 11, with the balloon in a distally positioned and inflated state, the cross-section taken along line 14-14 of FIG. 13;
  • FIG. 15 depicts a perspective view of the distal end of dilation device of FIG. 11, with the balloon in a distally positioned and inflated state;
  • FIG. 16 depicts a side elevational view of the dilation device of FIG. 11, with the balloon in a distally positioned and inflated state;
  • FIG. 17 depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with an exemplary uncinate process support positioned to maintain the uncinate process in the remodeled position of FIG. 8B;
  • FIG. 18 depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with another exemplary uncinate process support positioned to maintain the uncinate process in the remodeled position of FIG. 8B;
  • FIG. 19 depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with another exemplary uncinate process support positioned to maintain the uncinate process in the remodeled position of FIG. 8B;
  • FIG. 20 depicts a coronal cross-sectional view of the portion of the nasal cavity depicted in FIG. 6, with another exemplary uncinate process support positioned to maintain the uncinate process in the remodeled position of FIG. 8B;
  • FIG. 21 A depicts a side elevational view of an exemplary infundibular illuminating device, with an illuminating wire in a retracted position
  • FIG. 21B depicts a side elevational view of the infundibular illuminating device of FIG. 21 A, with the illuminating wire in an extended position.
  • proximal and distal are used herein with reference to a clinician gripping a handpiece assembly.
  • an end effector is distal with respect to the more proximal handpiece assembly.
  • spatial terms such as “top” and “bottom” also are used herein with respect to the clinician gripping the handpiece assembly.
  • surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
  • FIG. 1 shows an exemplary dilation catheter system (10) that may be used to dilate the ostium of a paranasal sinus; or to dilate some other anatomical passageway (e.g., within the ear, nose, or throat, etc.).
  • Dilation catheter system (10) of this example comprises a dilation catheter (20), a guide catheter (30), an inflator (40), and a guidewire (50).
  • dilation catheter system (10) may be configured in accordance with at least some of the teachings of U.S. Patent Pub. No. 2011/0004057, the disclosure of which is incorporated by reference herein.
  • dilation catheter system (10) is configured similar to the Relieva® Spin Balloon SinuplastyTM System by Acclarent, Inc. of Menlo Park, California.
  • the distal end of dilation catheter (20) includes an inflatable dilator (22).
  • the proximal end of dilation catheter (20) includes a grip (24), which has a lateral port (26) and an open proximal end (28).
  • Dilation catheter (20) includes a first lumen (not shown) that provides fluid communication between lateral port (26) and the interior of dilator (22).
  • Dilator catheter (20) also includes a second lumen (not shown) that extends from open proximal end (28) to an open distal end that is distal to dilator (22).
  • This second lumen is configured to slidably receive guidewire (50).
  • the first and second lumens of dilator catheter (20) are fluidly isolated from each other.
  • dilator (22) may be selectively inflated and deflated by communicating fluid along the first lumen via lateral port (26) while guidewire (50) is positioned within the second lumen.
  • dilator catheter (20) is configured similar to the Relieva UltirraTM Sinus Balloon Catheter by Acclarent, Inc. of Menlo Park, California.
  • dilator catheter (20) is configured similar to the Relieva Solo ProTM Sinus Balloon Catheter by Acclarent, Inc. of Menlo Park, California.
  • Other suitable forms that dilator catheter (20) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Guide catheter (30) of the present example includes a bent distal end (32) and a grip (34) at its proximal end. Grip (34) has an open proximal end (36).
  • Guide catheter (30) defines a lumen that is configured to slidably receive catheter (20), such that guide catheter (30) may guide dilator (22) out through bent distal end (32).
  • guide catheter (30) is configured similar to the Relieva FlexTM Sinus Guide Catheter by Acclarent, Inc. of Menlo Park, California. Other suitable forms that guide catheter (30) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Inflator (40) of the present example comprises a barrel (42) that is configured to hold fluid and a plunger (44) that is configured to reciprocate relative to barrel (42) to selectively discharge fluid from (or draw fluid into) barrel (42).
  • Barrel (42) is fluidly coupled with lateral port (26) via a flexible tube (46).
  • inflator (40) is operable to add fluid to dilator (22) or withdraw fluid from dilator (22) by translating plunger (44) relative to barrel (42).
  • the fluid communicated by inflator (40) comprises saline, though it should be understood that any other suitable fluid may be used.
  • inflator (40) is configured in accordance with at least some of the teachings of U.S. Pat. App.
  • guidewire (50) of the present example comprises a coil (52) positioned about a core wire (54).
  • An illumination wire (56) extends along the interior of core wire (54) and terminates in an atraumatic lens (58).
  • a connector (55) at the proximnal end of guidewire (50) enables optical coupling between illumination wire (56) and a light source (not shown).
  • Illumination wire (56) may comprise one or more optical fibers.
  • Lens (58) is configured to project light when illumination wire (56) is illuminated by the light source, such that illumination wire (56) transmits light from the light source to the lens (58).
  • the distal end of guidewire (50) is more flexible than the proximal end of guidewire (50).
  • Guidewire (50) has a length enabling the distal end of guidewire (50) to be positioned distal to dilator (22) while the proximal end of guidewire (50) is positioned proximal to grip (24).
  • Guidewire (50) may include indicia along at least part of its length (e.g., the proximal portion) to provide the operator with visual feedback indicating the depth of insertion of guidewire (50) relative to dilation catheter (20).
  • guidewire (50) may be configured in accordance with at least some of the teachings of U.S. Pub. No. 2012/0078118, the disclosure of which is incorporated by reference herein.
  • guidewire (50) is configured similar to the Relieva Luma SentryTM Sinus Illumination System by Acclarent, Inc. of Menlo Park, California. Other suitable forms that guidewire (50) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • guide catheter (30) may first be positioned near the targeted anatomical passageway, such as a sinus ostium (O). Dilator (22) and the distal end of guidewire (50) may be positioned within or proximal to bent distal end (32) of guide catheter (30) at this stage.
  • Guide catheter (30) is initially inserted into the nose of the patient and is advanced to a position that is within or near the ostium (O) to be dilated. This positioning of guide catheter (30) may be performed under visualization provided by an endoscope such as endoscope (60) described below.
  • the operator may advance guidewire (50) distally through guide catheter (30) such that a distal portion of the guidewire (50) passes through the sinus ostium (O) and into the sinus cavity.
  • the operator may illuminate illumination wire (56) and lens (58), which may provide transcutaneous illumination through the patient's face to enable the operator to visually confirm positioning of the distal end of guidewire (50) with relative ease.
  • dilation catheter (20) is advanced along guidewire (50) and through bent distal end (32) of guide catheter (30), with dilator (22) in a non-dilated state until dilator (22) is positioned within the sinus ostium (O) (or some other targeted anatomical passageway).
  • dilator (22) may be inflated, thereby dilating the ostium.
  • plunger (44) may be actuated to push saline from barrel (42) of inflator (40) through dilation catheter (20) into dilator (22).
  • dilator (22) may be inflated to a volume sized to achieve about 10 to about 12 atmospheres. Dilator (22) may be held at this volume for a few seconds to sufficiently open the ostium (O) (or other targeted anatomical passageway). Dilator (22) may then be returned to a non- expanded state by reversing plunger (44) of inflator (40) to bring the saline back to inflator (40). Dilator (22) may be repeatedly inflated and deflated in different ostia and/or other targeted anatomical passageways. Thereafter, dilation catheter (20), guidewire (50), and guide catheter (30) may be removed from the patient.
  • an endoscope (60) may be used to provide visualization within an anatomical passageway (e.g., within the nasal cavity, etc.) during a process of using dilation catheter system (10).
  • endoscope of the present example comprises a body (62) and a rigid shaft (64) extending distally from body (62).
  • the distal end of shaft (64) includes a curved transparent window (66).
  • a plurality of rod lenses and light transmitting fibers may extend along the length of shaft (64).
  • a lens is positioned at the distal end of the rod lenses and a swing prism is positioned between the lens and window (66).
  • the swing prism is pivotable about an axis that is transverse to the longitudinal axis of shaft (64).
  • the swing prism defines a line of sight that pivots with the swing prism.
  • the line of sight defines a viewing angle relative to the longitudinal axis of shaft (64). This line of sight may pivot from approximately 0 degrees to approximately 120 degrees, from approximately 10 degrees to approximately 90 degrees, or within any other suitable range.
  • the swing prism and window (66) also provide a field of view spanning approximately 60 degrees (with the line of sight centered in the field of view). Thus, the field of view enables a viewing range spanning approximately 180 degrees, approximately 140 degrees, or any other range, based on the pivot range of the swing prism. Of course, all of these values are mere examples.
  • Body (62) of the present example includes a light post (70), an eyepiece (72), a rotation dial (74), and a pivot dial (76).
  • Light post (70) is in communication with the light transmitting fibers in shaft (64) and is configured to couple with a source of light, to thereby illuminate the site in the patient distal to window (66).
  • Eyepiece (72) is configured to provide visualization of the view captured through window (66) via the optics of endoscope (60).
  • a visualization system e.g., camera and display screen, etc.
  • eyepiece (72) may be coupled with eyepiece (72) to provide visualization of the view captured through window (66) via the optics of endoscope (60).
  • Rotation dial (74) is configured to rotate shaft (64) relative to body (62) about the longitudinal axis of shaft (64). It should be understood that such rotation may be carried out even while the swing prism is pivoted such that the line of sight is non-parallel with the longitudinal axis of shaft (64).
  • Pivot dial (76) is coupled with the swing prism and is thereby operable to pivot the swing prism about the transverse pivot axis.
  • Indicia (78) on body (62) provide visual feedback indicating the viewing angle.
  • endoscope (60) may be configured in accordance with at least some of the teachings of U.S. Pub. No. 2010/0030031, the disclosure of which is incorporated by reference herein.
  • endoscope (60) is configured similar to the Acclarent CyclopsTM Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, California.
  • Other suitable forms that endoscope (60) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • FIG. 6 shows a coronal cross-sectional view of a left portion of a patient's nasal cavity.
  • FIG. 6 shows the nasal septum (NS), the middle turbinate (MT) lateral to the nasal septum (NS), and the uncinate process (UP) and ethmoid bulla (B) lateral to the middle turbinate (MT).
  • the uncinate process (UP) and the ethmoid bulla (B) together define the ethmoid infundibulum (EI), which is a transition space leading to the maxillary ostium (MO).
  • the maxillary ostium (MO) provides a passageway between the ethmoid infundibulum (EI) and the maxillary sinus (not shown).
  • dilation catheter system (10) it may be desirable to dilate the maxillary ostium (MO) of a patient or to otherwise reach the maxillary ostium (MO).
  • the uncinate process (UP) may make it difficult to visualize and reach the maxillary ostium (MO). It may therefore be desirable to at least temporarily move the uncinate process (UP), to thereby dilate the ethmoid infundibulum (EI) and improve access to (and visualization of) the maxillary ostium (MO).
  • EI ethmoid infundibulum
  • a balloon may be used to gently move the uncinate process (UP) since a balloon may provide a relatively large surface area contact.
  • dilating the ethmoid infundibulum (EI) in order to improve access to the maxillary ostium (MO), to thereby use dilation catheter system (10) to dilate the maxillary ostium (MO)
  • dilation catheter system (10) to dilate the maxillary ostium (MO)
  • EI ethmoid infundibulum
  • dilating the ethmoid infundibulum (EI) may simply provide patency to improve flow of air/mucus/etc. into and out of the maxillary sinus.
  • Dilating the ethmoid infundibulum (EI) may also facilitate the removal of obstructions from within the ethmoid infundibulum (EI).
  • FIG. 7 shows an exemplary dilation instrument (80) that may be used to gently move the uncinate process (UP), to thereby dilate the ethmoid infundibulum (EI) and improve access to (and visualization of) the maxillary ostium (MO).
  • Dilation instrument (80) of this example comprises a handpiece (82), and a shaft (84) extending distally from handpiece (82). At least a portion of shaft (84) may be malleable or semi-rigid.
  • Shaft (84) includes a curved probe tip (86).
  • the curvature and length of probe tip (86) are selected to enable curved probe tip (86) to be positioned around the uncinate process (UP) and into the ethmoid infundibulum (EI).
  • a dilator (88) is disposed about curved probe tip (86) and is operable to transition between an inflated state and a non-inflated state. Dilator (88) is thus similar to dilator (22) described above. However, in the present example dilator (88) is inflatable to a larger cross-sectional area than dilator (22), since dilator (22) is configured to dilate smaller passageways (e.g., sinus ostia) than dilator (88).
  • Dilator (88) is formed of a compliant material such that its shape will conform to the shape of anatomical structures that dilator (88) bears against when in an inflated state.
  • dilator (88) may be formed of a thermoplastic elastomer such as urethane, polyether block amide such as PEBAX® (by Arkema of Paris, France), Hytrel® (by E. I. du Pont de Nemours and Company of Wilmington, Delaware), and/or any other suitable material(s).
  • Dilator (88) is in fluid communication with a port (90) located at the proximal end of handpiece (82).
  • Port (90) is configured to couple with a fluid source (e.g., a source of saline) via any suitable means.
  • a fluid source e.g., a source of saline
  • port (90) may comprise a leur connector.
  • dilation instrument (80) is inserted into the patient's nasal cavity and curved probe tip (86) is navigated around the uncinate process (UP) into the ethmoid infundibulum (EI). This may be accomplished using direct vision, endoscope (60) described above, some other kind of endoscope, or some other means of visualization.
  • dilator (88) Once curved probe tip (86) is appropriately positioned, fluid is communicated to dilator (88) via port (90), such that dilator (88) transitions to an inflated state as shown in FIG. 8A. As dilator (88) inflates, dilator (88) dilates the ethmoid infundibulum (EI). It should be understood that one or more of the anatomical structures around the ethmoid infundibulum (EI) may be moved by dilator (88) to provide this dilation. In some instances, inflating dilator (88) moves the uncinate process (UP) inferiorly and/or anteriorly.
  • EI ethmoid infundibulum
  • inflating dilator (88) may move the middle turbinate (MT) medially.
  • inflating dilator (88) may move ethmoid bulla (B) superiorly and/or posteriorly. Because dilator (88) is formed of a compliant material, it conforms to the shape of the uncinate process (UP), the middle turbinate (MT), and the ethmoid bulla (B), such that the contact between dilator (88) and the uncinate process (UP), the middle turbinate (MT), and the ethmoid bulla (B) is over a maximum surface area. This may reduce the risk of trauma to the uncinate process (UP), the middle turbinate (MT), and the ethmoid bulla (B) due to expansion of dilator (88).
  • FIG. 8B the result is shown in FIG. 8B, where the passageway provided by the ethmoid infundibulum (EI) is significantly larger than the pre-dilation passageway shown in FIG. 6.
  • This larger, dilated passageway provided by the ethmoid infundibulum (EI) enhances access to and visualization of the maxillary ostium (MO).
  • an additional device may be installed to maintain the dilation of the ethmoid infundibulum (EI).
  • dilation instrument (80) may be inserted through guide catheter (30) or a variation thereof.
  • dilation instrument (80) may be constructed as a variation of dilator catheter (20) (e.g., having a dilator (88) that is different from dilator (22)).
  • Dilation instrument (80) may also be configured to slide along a guidewire such as guidewire (50).
  • dilation instrument (80) may be used without any kind of guide catheter (30) or guidewire (50).
  • dilation instrument (80) may be constructed and operable in accordance with at least some of the teachings of U.S. Pub. No. 2010/0030113, entitled “Paranasal Ostium Finder Devices and Methods," published February 4, 2010, the disclosure of which is incorporated by reference herein.
  • FIGS. 9A-10B show another exemplary dilation instrument (100) that may be used to dilate nasal and paranasal structures.
  • Dilation instrument (100) of the present example comprises a hollow rail (110) and a dilator assembly (120) that translates along rail (110).
  • the exterior of rail (110) presents a pair of inwardly extending tracks (118) along the length of rail (110).
  • Tracks (118) are configured to enable translation of dilator assembly (120) along rail (110) as will be described in greater detail below.
  • Rail (110) includes a radiused curved region (112) and a distally narrowing tapered region (114) distal to curved region (112).
  • the taper of tapered region (114) extends along at least part of the length of curved region (1 12).
  • a ball tip (116) is positioned at the distal end of tapered region (114).
  • the curvature of curved region (112) is selected to facilitate positioning of the distal end of dilation instrument (100) in a paranasal passageway (e.g., in the ethmoid infundibulum (EI), etc.).
  • the configuration of ball tip (116) is atraumatic to reduce the risk of inadvertently damaging tissue while navigating dilation instrument (100) into position. It should also be understood that ball tip (116) may be used for atraumatic exploration of areas such as the frontal recess in a patient.
  • the frontal recess may have several pathways, some of which are "dead ends" known as terminal recesses.
  • Ball tip (116) may allow the operator to assess whether a recess leads to other structures or is a terminal recess.
  • Dilator assembly (120) of the present example comprises an inflatable dilator (122) secured to a sled platform (124).
  • dilator (122) and sled platform (124) are located at an angular position about the longitudinal axis of rail (110) such that dilator (122) and sled platform (124) are on the inside of the curve defined by curved region (112).
  • dilator (122) and sled platform (124) are oriented such that dilator (122) and sled platform (124) are on the outside of the curve defined by curved region (112).
  • dilator (122) and sled platform (124) may be oriented such that dilator (122) and sled platform (124) are on a lateral side (e.g., 90 degrees from the inside/outside) of the curve defined by curved region (112).
  • Sled platform (124) includes a pair of guide blocks (130), though it should be understood that any suitable number of guide blocks (130) may be used.
  • guide blocks (130) include integral male key elements (132) that project inwardly and are received in tracks (118).
  • Dilator (122) is in fluid communication with a conduit (140), which extends through the hollow interior of rail (1 10).
  • Dilator (122) may be formed of a compliant material just like dilator (88) described above.
  • conduit (140) bends transversely and passes through platform (124) to reach conduit (140).
  • the distal end of conduit (140) includes an angled fitting that couples conduit (140) with dilator (122).
  • Rail (110) defines a longitudinally extending slot that enables conduit (140) or the fitting to pass from the interior of rail (110) to platform (124).
  • Conduit (140) translates with dilator assembly (120) as dilator assembly (120) translates along rail (110). It should be understood that a variety of features may be used to drive translation of dilator assembly (120) along rail (110).
  • platform (124) may be secured to a drive tube that is slidably disposed about the exterior of rail (110), such that platform (124) may be translated by translating the drive tube relative to rail (110).
  • platform (124) may be driven by a push/pull cable feature.
  • dilator assembly (120) may be translated along rail (110) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • dilation instrument (100) is initially positioned such that tapered region (114) is located within the desired anatomical region while dilator assembly (120) is in the retracted position and non-inflated state shown in FIGS. 9 A and 10A.
  • dilation instrument (100) may be positioned such that tip (116) is located within the ethmoid infundibulum (EI), just medial to the maxillary ostium (MO), with curved region (112) reaching around the uncinate process (UP).
  • EI ethmoid infundibulum
  • MO maxillary ostium
  • curved region (112) reaching around the uncinate process (UP).
  • dilator assembly (120) is advanced distally along rail (110) until dilator (122) is positioned adjacent to the uncinate process (UP).
  • Platform (124) is compliant enough to traverse curved region (112) while remaining engaged with rail (110) and without deforming rail (110) during such traversal.
  • Some versions of platform (124) may include transversely extending ribs or other reinforcement features that enable such deformation without promoting deformation of platform (124) about the longitudinal axis of rail (110).
  • conduit (140) to inflate dilator (122) to the inflated state shown in FIGS. 9B and 10B.
  • dilator (122) drives the uncinate process (UP) medially and/or inferiorly, thereby dilating the ethmoid infundibulum (EI). Due to the general rigidity of rail (110) and the presence of platform (124), the only forces exerted on the patient's anatomy by inflation of dilator (122) are on the uncinate process (UP).
  • the rigidity of rail (110) and platform (124) provides a mechanical ground that absorbs forces exerted by dilator (122) toward the ethmoid bulla (B) and the middle turbinate (MT), such that neither dilator (122) nor rail (110) bears against the ethmoid bulla (B) or the middle turbinate (MT) during inflation of dilator (122).
  • Platform (124) thus constrains expansion of dilator (122) to only a restricted angular range (i.e., less than 360°) about the longitudinal axis of rail (100).
  • dilation instrument (100) may incidentally contact the ethmoid bulla (B) or the middle turbinate (MT) during inflation of dilator (122), those anatomical structures are not moved or remodeled by inflation of dilator (122).
  • the forces exerted on the patient's anatomy by the inflation of dilator are thus asymmetric relative to the longitudinal axis of rail (110).
  • dilator (122) has been inflated to dilate the ethmoid infundibulum (EI)
  • the fluid may be removed from dilator (122) and dilation instrument (100) may be removed from the patient.
  • dilation assembly (120) is retracted to a proximal position along rail (110) before rail (110) is pulled out of the patient. In some other instances, rail (110) is pulled out of the patient while dilation assembly (120) remains at a distal position along rail (110).
  • dilation instrument (100) may be used in various other procedures and in various other parts of a patient's anatomy. By way of example only, dilation instrument (100) may be used to dilate the frontal recess (FR) that extends between the ethmoid infundibulum (EI) or adjacent spaces and the frontal paranasal sinus.
  • dilation instrument (100) is discussed herein in the context of dilating the frontal recess (FR), it should be understood that dilation instrument (100) and variations thereof may be readily used in various other procedures and locations.
  • dilation instrument (100) may be used to dilate structures within the frontal recess, which is the passageway that courses past the ethmoid bulla (B) and up to the frontal sinus.
  • Pneumatized air cells may form part of the boundaries of the frontal recess, such that it may be advantageous to be able to perform selective dilatation in that area so as to choose which of these cells to apply force to.
  • dilation instrument (100) of the present example allows for selective remodeling of an agger nasi air cell (typically found anterior to the frontal recess (FR)) while not applying force to a suprabullar air cell (which typically lies posterior to the frontal recess (FR)).
  • a suprabullar air cell can be selectively remodeled while not applying force to the agger nasi cell.
  • Other procedures and locations in which dilation instrument (100) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • dilator (122) may be advanced to (and dilated at) any suitable location along the length of rail (110). In other words, in some uses dilator assembly (120) stops advancing at curved region (112) or proximal to curved region (112), with dilator (122) then being inflated at that point. In some alternative versions of dilation instrument (100), dilator assembly (120) does not translate along rail (110) and is simply fixed in position at the distal end of rail (110). Various suitable ways in which dilation instrument (100) may be configured and used will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • FIGS. 1 1-16 show another exemplary dilation instrument (700) that may be used to dilate nasal and paranasal structures.
  • dilation instrument (700) may be used in the same procedures and parts of a patient's anatomy as identified above with respect to dilation instrument (100).
  • Dilation instrument (700) of the present example comprises a handle (710), a rigid guide catheter (720), a guidewire (730), and a dilation catheter (740).
  • Handle (710) is provided so that a surgeon or other operator can controllably position dilation instrument (700) and apply grounding forces to dilation instrument (700) in order to counter forces that are encountered during dilation and to thus maintain a stable position of dilation instrument (700) relative to the head of the patient.
  • Handle (710) comprises a plurality of slidable actuators (712) and a plurality of laterally extending gripping members (714). Actuators (712) are configured to slide along the body of handle (710) to permit a user to independently advance guidewire (730), dilation catheter (740), and/or other components relative to handle (710).
  • Gripping members (714) are configured to fit between and adjacent to a user's fingers to thereby permit a user to firmly grasp handle (710) with a single hand.
  • handle (710) may have any other suitable configuration.
  • handle (710) may be configured similarly to dilation catheter system (10) described above, where various functional components also serve as a grip for an operator.
  • Other suitable forms that handle (710) may take will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Guide catheter (720) extends distally from handle (720).
  • guide catheter (720) is rigid, though in some other versions at least a portion of guide catheter (720) may be flexible or semi-rigid.
  • Guide catheter (720) has a lumen (not shown) extending axially therethrough with an open distal end (722).
  • guidewire (730) may be slidably disposed within the lumen of guide catheter (720) such that the operator may advance guidewire (730) axially through open distal end (722).
  • guide catheter (720) comprises a curved portion (724) near open distal end (722) of guide catheter (720).
  • curved portion (724) may be more or less curved, or omitted entirely, with such a curve being adapted for dilation of the drainage pathway of a particular paranasal sinus.
  • a set of instruments (700) may have guide catheters (720) with curved portions (724) presenting different curvatures, such that the operator may select a particular instrument (700) from the set with a curved portions (724) having a curvature that is particularly suited for the anatomical location in which instrument (700) will be used.
  • Various suitable curvatures that curved portion (724) may have will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • guidewire (730) is slidably disposed within the lumen of guide catheter (720).
  • Guidewire (730) may have an illuminating tip such that guidewire (730) may provide transillumination through regions of a patient's head.
  • guidewire (730) may include one or more electromagnetic tracking features, a distal camera assembly, a distal ultrasonic transducer, and/or any other suitable feature(s), including combinations thereof.
  • the distal end of guidewire (730) comprises a ball tip (732).
  • ball tip (732) may enable guidewire (730) to be used to like a conventional "sinus seeker" instrument to atraumatically probe and/or investigate anatomical regions in a patient's head.
  • ball tip (732) has an outer diameter that is greater than the inner diameter of the lumen of guide catheter (720), such that ball tip (732) is prevented from being pulled proximally into distal end (722) of guide catheter (720).
  • guidewire (730) is coupled with an actuator (712) of handle assembly (710), such that actuator (712) may be translated relative to handle assembly (710) to thereby translate guidewire (730) relative to guide catheter (720).
  • actuator (712) may be translated relative to handle assembly (710) to thereby translate guidewire (730) relative to guide catheter (720).
  • This may enable the operator to selectively translate guidewire (730) between a proximal position (in which ball tip (732) is in contact with distal end (722) of guide catheter (720)) and various distal positions (in which ball tip (732) is spaced distally from distal end (722) of guide catheter (720)).
  • an actuator (712) may include a rotating element to further provide selective rotation of guidewire (730), about the longitudinal axis of guidewire (730), relative to guide catheter (720).
  • one or more actuators (712) that are associated with guidewire (730) may be provided in accordance with at least some of the teachings of U.S. Pub. No. 2012/0071856, entitled “Medical Device and Method for Treatment of a Sinus Opening,” published March 22, 2012, the disclosure of which is incorporated by reference herein.
  • various other features of instrument (700) may be constructed and operable in accordance with at least some of the teachings of U.S. Pub. No. 2012/0071856.
  • Dilation catheter (740) is positioned coaxially relative to guide catheter (720) such that dilation catheter (740) wraps around guide catheter (720) like a sheath.
  • dilation catheter (740) comprises a catheter portion (742), a balloon dilator (744), and two retaining rings (746) that are positioned on each end of balloon dilator (744).
  • Catheter portion (742) extends distally from handle (710), through balloon dilator (744), and terminates at an open distal end (743) positioned distally of balloon dilator (744).
  • Catheter portion (742) defines a lumen (not shown) that permits guide catheter (720) to extend through the length of catheter portion (742).
  • Catheter portion (742) also provides an inflation lumen (not shown) in fluid communication with balloon dilator (744), such that the inflation lumen may be used to inflate balloon dilator (744) as will be described in greater detail below.
  • At least part of catheter portion (742) is flexible in the present example, such that catheter portion (742) may be translated relative to guide catheter (720) to selectively drive balloon dilator (744) between a proximal position (where balloon dilator (744) is positioned along and/or proximal to curved portion (724)) and a distal position (where balloon dilator (744) is positioned along and/or distal to curved portion (724)).
  • one of the actuators (712) of handle (710) is operable to translate dilation catheter (740) relative to guide catheter (720).
  • one or more actuators (712) that are associated with dilation catheter (740) may be provided in accordance with at least some of the teachings of U.S. Pub. No. 2012/0071856, entitled “Medical Device and Method for Treatment of a Sinus Opening,” published March 22, 2012, the disclosure of which is incorporated by reference herein.
  • handle (710) may include an actuator (712) or other feature that enables the operator to rotate dilation catheter (740) about the longitudinal axis of guide catheter (720), thereby enabling the operator to selectively position balloon dilator (744) at a desired angular position about the longitudinal axis of guide catheter (720).
  • Balloon dilator (744) is positioned about catheter portion (742) near the open distal end (743) of catheter portion (742).
  • Balloon dilator (744) is comprised of a semi- compliant material in the present example.
  • balloon dilator (744) may be compliant or non-compliant and may comprise any other suitable material such as polyamid (Nylon), polyurethane, polydimethyl siloxane (Silicone), polyester, polyolefm, etc.
  • suitable materials and combinations of materials that may be used to form balloon dilator (744) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Retaining rings (746) are positioned at each end of balloon dilator (744) and completely encircle catheter portion (742) and each end of balloon dilator (744).
  • retaining rings (746) are fixedly secured to balloon dilator (744).
  • retaining rings (746) may be at least partially slidable relative to balloon dilator (744) and/or catheter portion (742).
  • Retaining rings (746) are connected to each other by a plurality of inelastic retaining wires (748) that extend from one retaining ring (746) to the other.
  • Retaining wires (748) may be grouped together to restrict the inflation of balloon dilator (744) in a given lateral direction, as will be described in greater detail below.
  • retaining wires (748) are connected to each other to form a web-like configuration.
  • retaining wires (748) are arranged such that there are a plurality (e.g., three) of longitudinally extending retaining wires (748) and a plurality (e.g., three) of transversely extending retaining wires (748).
  • the transversely extending retaining wires (748) are secured to the longitudinally extending retaining wires (748).
  • Such a web-like configuration may maintain retaining wires (748) in a fixed relationship relative to each other or at least restrict the degree to which the longitudinally extending retaining wires (748) may laterally separate from each other.
  • retaining wires (748) may be arranged in any suitable manner. It should also be understood that connections between retaining wires (748) may be omitted such that retaining wires are independent of each other.
  • both retaining rings (746) and retaining wires (748) are comprised of a metallic material such that they may be welded together.
  • retaining rings (746) and retaining wires (748) may be comprised of a polymer or other plastic and are fused or otherwise bonded together (e.g., with an adhesive, etc.).
  • retaining rings (746) and retaining wires (748) may be dissimilar materials.
  • retaining rings (746) and retaining wires (748) may be of any other suitable material and may be combined by any other suitable means as will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • retaining wires (748) are laterally flexible yet longitudinally inelastic such that the length of each retaining wire (748) is fixed. In some other versions, retaining wires (748) are rigid. In either case, retaining wires (748) cooperate with retaining rings (746) to restrict inflation of balloon dilator (744) on the side of balloon dilator (744) at which wires (748) are positioned. Balloon dilator (744) thus has a constrained side (or region) and an non-constrained side (or region), such that balloon dilator (744) will inflate asymmetrically about the longitudinal axis of dilation catheter (740). In other words, wires (748) constrains expansion of balloon dilator (744) to only a restricted angular range (i.e., less than 360°) about the longitudinal axis of guide catheter (720).
  • retaining wires (748) may take, as well as various other suitable properties retaining wires (748) may have, will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that wires (748) are just one example. Any other suitable kinds of structures may be used to constrain expansion of balloon dilator (744) on one side of balloon dilator (744).
  • dilation instrument (700) is initially positioned such that open distal end (722) of guide catheter (720) is located within the desired anatomical region while dilation catheter (740) is in a retracted position and non-inflated state shown in FIG. 11.
  • dilation instrument (700) may be positioned such that open distal end (722) of guide catheter (720) is located within the frontal recess, near an agger nasi air cell and suprabullar air cell.
  • Such positioning of the guide catheter (720) may be accomplished using transillumination provided by guidewire (730).
  • ball tip (732) may be positioned at or distal to distal end (722) of guide catheter (720) such that guide catheter (720) may be used as a seeker tip.
  • endoscopic visualization may be used to assist with positioning of guide catheter (720).
  • balloon dilator (744) is positioned adjacent to the structure that is to be dilated.
  • Catheter portion (742) and balloon dilator (744) are compliant enough to traverse curved portion (724) of guide catheter (720).
  • balloon dilator (744) may be positioned adjacent to an agger nasi air cell and an suprabullar air cell.
  • balloon dilator (744) may be positioned in any desired position as will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • some versions may permit rotation of dilation catheter (740) about guide catheter (720), such that the non-constrained side of balloon dilator (744) may be selectively located at a desired angular position about the longitudinal axis of guide catheter (720).
  • rigid wires (748) are configured to prevent the expansion of balloon dilator (744) in a particular direction or range of directions. Rigid wires (748) further act to transfer force from the restricted side of balloon dilator (744) to handle (710) via guide catheter (720) such that an operator may direct the force of expansion toward a structure that is intended to be remodeled. Thus, the expansion of balloon dilator (744) may reconstruct one anatomical structure while leaving another adjacent anatomical structure unaffected.
  • rigid wires (748) are configured to prevent the expansion of balloon dilator (744) in a particular direction or range of directions. Rigid wires (748) further act to transfer force from the restricted side of balloon dilator (744) to handle (710) via guide catheter (720) such that an operator may direct the force of expansion toward a structure that is intended to be remodeled.
  • the expansion of balloon dilator (744) may reconstruct one anatomical structure while leaving another adjacent anatomical structure unaffected.
  • balloon dilator (744) when balloon dilator (744) is positioned within the fontal recess, with the expanding portion of balloon dilator (744) anterior to the frontal recess, balloon dilator (744) may reconstruct the agger nasi air cell while leaving an adjacent suprabullar air cell intact.
  • dilation instrument (700) or dilation catheter (740)
  • dilation catheter (740) may be rotated 180° such that the expanding portion of balloon dilator (744) is posterior to the frontal recess to reconstruct the suprabullar air cell while leaving the adjacent agger nasi air cell intact.
  • balloon dilator (744) is configured to selectively apply a force to an anatomical structure on one side of balloon dilator (744) while not applying force to the anatomical structure on the other side of balloon dilator (744).
  • dilation instrument (700) may include other structures that may be used to assist in mechanically grounding handle (710) such that the expansion of balloon dilator (744) causes remodeling of only the anatomical structure that is on the expandable side of balloon dilator (744).
  • mechanical grounding may prevent the expansion of balloon dilator (744) from remodeling the anatomical structure that is on the same side of balloon dilator (744) as wires (748) (i.e., the constrained side of balloon dilator (744)).
  • Such mechanical grounding may, for example, include an external structure that is mounted to a patient table, a procedure chair, or any other suitable structure.
  • dilation instrument (700) may be used in various other procedures and in various other parts of a patient's anatomy (e.g., in some other outflow tract of a patient's paranasal sinus).
  • balloon dilator (744) may be advanced to (and dilated at) any suitable location along the length of guide catheter (720). In other words, in some uses dilation catheter (740) stops advancing at curved portion (724) or proximal to curved portion (724), with balloon dilator (744) then being inflated at that point.
  • dilation catheter (740) does not translate along guide catheter (720) and is simply fixed in position at the distal end of guide catheter (720).
  • dilation instrument (700) may be configured and used will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • dilation instruments 80, 100, 700 may be used to dilate the ethmoid infundibulum (EI) by moving the uncinate process (UP), to dilate the frontal recess (FR), and/or to dilate other anatomical structures.
  • this process may effectively remodel the uncinate process (UP) and/or other anatomical structure(s) such that the ethmoid infundibulum (EI) remains dilated for at least a desired period of time.
  • the uncinate process (UP) and/or other anatomical structure(s) may eventually move back to a previous position and/or other conditions may eventually arise where the ethmoid infundibulum (EI) is no longer effectively dilated. This may or may not be undesirable.
  • one or more implantable devices may be installed at or near the ethmoid infundibulum (EI) to maintain the dilated state.
  • implantable devices are described in greater detail below while others will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • implantable devices described below may be used after either of the dilation instruments (80, 100, 700) described above have been used to dilate the ethmoid infundibulum (EI); or after some other instrument has been used to dilate the ethmoid infundibulum (EI).
  • dilation instruments 80, 100, 700
  • some other instrument has been used to dilate the ethmoid infundibulum (EI).
  • implantable devices described below may be positioned and installed will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • any of the below described implantable devices may be installed using visualization from endoscope (60) or some other form of visualization.
  • FIG. 17 shows an exemplary wedge (200) that may be used to maintain dilation of the ethmoid infundibulum (EI).
  • Wedge (200) of this example comprises a pair of legs (202) that are joined together at a vertex (204), thereby forming a wedge angle.
  • wedge (200) is oriented such that vertex (204) points generally medially toward the middle turbinate (MT).
  • MT middle turbinate
  • wedge (200) is oriented such that vertex (204) points toward the maxillary ostium (MO).
  • wedge (200) may be positioned such that vertex (204) points anteriorly, posteriorly, superiorly, inferiority, or any suitable combination thereof.
  • the free end of each leg (202) includes a respective barbed anchor (206).
  • one anchor (206) is secured in the ethmoid bulla (B) in this example while the other anchor is secured in the uncinate process (UP).
  • anchors (206) may be secured elsewhere.
  • vertex (204) may include an anchor in addition to or in lieu of legs (202) having anchors (206).
  • vertex (204) may have an anchor that is secured in the middle turbinate (MT).
  • Other suitable arrangements will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • Wedge (200) may be formed of a rigid material.
  • wedge (200) may be formed of a malleable material.
  • wedge (200) may be formed of a resilient material that is biased to assume a position like the one shown in FIG. 17; yet that compresses to facilitate insertion of wedge (200) into the final installation position.
  • wedge (200) is formed by a pair of rigid legs that pivot at or near vertex (204).
  • a mechanical hinge or a living hinge may be located at or near vertex (204).
  • Such a hinge may be resiliently biased or may be selectively locked/unlocked to enable installation of wedge (200).
  • wedge (200) may be installed at any suitable position along the length of the uncinate process (UP), and that the configuration of wedge (200) should not obstruct the fluid path through the ethmoid infundibulum (EI). It should also be understood that wedge (200) may be formed of a bioabsorbable material, if desired. By way of example only, wedge (200) may be formed of polylactic acid (PLA), polydioxanone (PDS), polycaprolactone, and/or any other suitable material(s).
  • PLA polylactic acid
  • PDS polydioxanone
  • polycaprolactone polycaprolactone
  • FIG. 18 shows an exemplary mesh scaffold (300) that may be in used to maintain dilation of the ethmoid infundibulum (EI).
  • Scaffold (300) may be installed within the ethmoid infundibulum (EI) such that scaffold (300) is interposed between the ethmoid bulla (B) and the uncinate process (UP).
  • scaffold (300) is formed of a resilient material (e.g., nitinol, etc.), such that scaffold (300) is held in a compressed state until it reaches the installation site where it is then released to expand outwardly.
  • scaffold (300) may both hold the ethmoid infundibulum (EI) in the dilated state and effectively secure scaffold to the ethmoid bulla (B) and the uncinate process (UP) (e.g., due to mucosa tissue protruding through the openings defined between the wires forming the mesh of scaffold (300), etc.).
  • scaffold (300) is malleable such that scaffold (300) is actively expanded to reach the state shown in FIG. 18.
  • scaffold (300) may be positioned about the exterior of a dilator while scaffold is in a non-expanded state and while the dilator is in the non-inflated state.
  • the dilator and scaffold (300) may then be positioned in the ethmoid infundibulum (EI), wherein the dilator may then be inflated to dilate the ethmoid infundibulum (EI). Scaffold (300) may expand with the dilator in the ethmoid infundibulum (EI). The dilator may then be deflated and removed from the patient, leaving scaffold (300) in place in an expanded state within the ethmoid infundibulum (EI).
  • Other suitable configurations, properties, and installation techniques for scaffold (300) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • FIG. 19 shows an exemplary tether (400) that may be used to maintain dilation of the ethmoid infundibulum (EI).
  • Tether (400) of this example comprises an elongate body (402) that has hook anchors (404) at each end.
  • One hook anchor (404) is secured to the inferior side of the uncinate process (UP) while the other hook anchor (404) is secured to the medial side of the lateral wall (LW).
  • Tether body (402) is configured to maintain tension between anchors (404), thereby holding the uncinate process (UP) in the position shown in FIG. 19, to thereby maintain dilation of the ethmoid infundibulum (EI).
  • tether (400) may comprise polyester or some other biocompatible textile that does not stretch.
  • tether (400) may comprise a metal and/or plastic material.
  • Other suitable materials and configurations that may be incorporated into tether (400) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • tether (400) is installed while a separate dilator is used to move and temporarily hold the uncinate process (UP) into the position shown in FIG. 19.
  • tether (400) is used to move the uncinate process (UP) into the position shown in FIG. 19.
  • a hook anchor (404) may first be secured in the inferior side of the uncinate process (UP) or on any other region of the uncinate process (UP). The operator may then pull on tether body (402) to move the uncinate process (UP) medially and/or anteriorly. While holding the moved position of the uncinate process (UP), the operator may then secure the other hook anchor (404) the medial side of the lateral wall (LW).
  • Other suitable ways in which tether (400) may be installed will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • FIG. 20 shows another exemplary positioning device (500) that may be used to maintain dilation of the ethmoid infundibulum (EI).
  • Device (500) is configured for installation in a position where device (500) will bear medially on the middle turbinate (MT) while bearing anteriorly on the uncinate process (UP).
  • Device (500) of this example comprises a resilient mesh body (502). It should be understood that a mesh is just one example, and that any other suitable kind of structure may be used to form body (502). It should also be understood that body (502) may be malleable instead of being resilient. Other suitable configurations and properties for device (500) will be apparent to those of ordinary skill in the art in view of the teachings herein. Similarly, various suitable ways in which device (500) may be installed will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • the natural anatomy of the ethmoid infundibulum (EI) may make it difficult to access the maxillary ostium (MO).
  • the anatomy of the ethmoid infundibulum (EI) may also make it difficult to effectively illuminate and visualize the ethmoid infundibulum (EI) (e.g., to thereby visualize the maxillary ostium (MO)).
  • EI ethmoid infundibulum
  • MO maxillary ostium
  • EI ethmoid infundibulum
  • MO maxillary ostium
  • endoscope (60) may not provide sufficient illumination/visualization of the ethmoid infundibulum (EI) and/or the maxillary ostium (MO). It may therefore be desirable to provide an additional illumination and/or visualization device that provides enhanced illumination/viewing capabilities within the ethmoid infundibulum (EI). Examples of such devices are described in greater detail below, while still other examples will be apparent to those of ordinary skill in the art in view of the teachings herein. While the exemplary devices are described in the context of illuminating/viewing the ethmoid infundibulum (EI), it should be understood the devices described below may be readily used in various other regions of the nasal cavity.
  • FIGS. 21A-21B show an exemplary infundibular illuminator (600) that is operable to illuminate the ethmoid infundibulum (EI).
  • Illuminator (600) of this example comprises an outer tube (610) and an inner tube (620) that is slidably disposed in outer tube (610).
  • Outer tube (610) is formed of a rigid or semi-rigid material (e.g., a metal, plastic, and/or other material).
  • Outer tube (610) has a radiused curved region (612) that terminates in distal end (614).
  • curved region (612) is defined by a constant radius sweeping along an arc angle (O-theta), beginning at the proximal portion of curved region (612) and ending at distal end (614).
  • the arc angle (O-theta) is at least 90 degrees.
  • the arc angle (O-theta) is at least 135 degrees.
  • the arc angle (O-theta) is at least 180 degrees.
  • Curved region (612) may be rigid, semi-rigid, or resilient. For instance, at least a portion of curved region (612) may be resiliently biased to assume the position shown in FIG. 21A.
  • Inner tube (620) has a distal tip (622) and at least one internal optical fiber (624).
  • Distal tip (622) of the present example has a wedge-like profile but is atraumatic. Thus, when distal tip (622) is advanced into a narrowly defined ethmoid infundibulum (EI), distal tip (622) may assist in driving the ethmoid bulla (B) and uncinate process (UP) apart without causing damage to either anatomical structure.
  • illuminator (600) is used in conjunction with one of the support devices discussed above for maintaining dilation of the ethmoid infundibulum (EI), such that tip (622) may not need to drive apart the ethmoid bulla (B) and uncinate process (UP).
  • Optical fiber (624) extends along the length of inner tube (620) and is coupled with a light source (630) via an optical cable (640).
  • Light source (630) may comprise a conventional external light source.
  • light source (630) is integrated into illuminator (600).
  • illuminator (600) also includes an integral power source (e.g., a battery) to power light source (630).
  • Light source (630) may comprise an LED, laser, or any other suitable source of light.
  • Light source (630) may also be configured to generate light having a specific wavelength associated with specific types of normal and/or diseased tissue, such that the light from light source (630) will make such tissue visibly stand out.
  • Cable (640) and fiber (624) are configured to transmit light from light source
  • Tip (622) comprises a transparent or translucent material that is configured to project light from fiber (624).
  • tip (622) may illuminate the ethmoid infundibulum (EI) when tip (622) is positioned within the ethmoid infundibulum (EI).
  • other portions of inner tube (620) may also provide illumination.
  • inner tube (620) may include a plurality of transversely extending light pipes located proximal to tip (622).
  • inner tube (620) may be advanced distally relative to outer tube (610) (as shown in FIG. 2 IB) to extend tip (622) further into the ethmoid infundibulum (EI), thereby illuminating further depths of the ethmoid infundibulum (EI).
  • inner tube (620) of the present example is steerable, such that the portion of inner tube (620) extending distal to distal end (614) may be selectively deflected away from an axis that is perpendicular to the opening defined by distal end (614). This may further enhance control of illumination by illuminator (600) within the ethmoid infundibulum (EI).
  • illuminator (600) may lack inner tube (620), such that tip (622) is unitary with distal end (614) of outer tube (610).
  • inner tube (620) may be advanceable but not steerable.
  • a light emitting feature within inner tube (620) may be steerable while inner tube (620) itself is not steerable.
  • a light emitting feature within inner tube (620) may be pivotable within inner tube (620).
  • curved region (612) may enable illuminator (600) to be used as a retractor.
  • illuminator (600) may be positioned such that tip (622) is used to initially drive the ethmoid bulla (B) and uncinate process (UP) apart.
  • illuminator (600) may be gently pulled inferiorly to displace the uncinate process (UP) and open the ethmoid infundibulum (EI) wider. Illuminator (600) may thus be used as an uncinate process (UP) retractor.
  • Outer tube (610) may include a soft outer material (e.g., rubber, foam, etc.) to minimize trauma to the uncinate process (UP) when illuminator (600) is used as a retractor.
  • the operator may manipulate tip (622) to illuminate the ethmoid infundibulum (EI).
  • the combination of uncinate process (UP) retraction and ethmoid infundibulum (EI) illumination provided by illuminator (600) may greatly enhance visualization of the ethmoid infundibulum (EI). In some instances, this may enable the operator to view the ethmoid infundibulum (EI) (and in some cases the maxillary ostium (MO)) using endoscope (60) while using illuminator (600) as a retractor and as a source of light.
  • illuminator (600) may itself include an optical assembly that enables viewing through illuminator (600).
  • Various other suitable components, configurations, and methods of operating illuminator (600) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • any of the examples described herein may include various other features in addition to or in lieu of those described above.
  • any of the examples described herein may also include one or more of the various features disclosed in any of the various references that are incorporated by reference herein.
  • Versions described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure.
  • reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • versions described herein may be sterilized before and/or after a procedure.
  • the device is placed in a closed and sealed container, such as a plastic or TYVEK bag.
  • the container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
  • the radiation may kill bacteria on the device and in the container.
  • the sterilized device may then be stored in the sterile container for later use.
  • a device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)
  • Endoscopes (AREA)

Abstract

La présente invention concerne un appareil de dilatation comprenant un élément allongé et un ensemble de dilatation apte à coulisser le long de l'élément allongé. L'ensemble de dilatation comprend une plate-forme et un dilatateur gonflable. La plate-forme et l'élément allongé coopèrent pour absorber les forces de gonflage en provenance du dilatateur et dirigées vers l'axe longitudinal de l'élément allongé, de sorte que les forces de dilatation s'exercent contre les tissus de manière asymétrique par rapport à l'axe longitudinal de l'élément allongé. L'appareil de dilatation peut être utilisé pour dilater le canal naso-frontal chez un patient humain. Divers dispositifs peuvent être utilisés pour maintenir l'état dilaté d'un canal naso-frontal, notamment un coin, une maille et une attache. Un illuminateur peut être conçu pour atteindre la périphérie d'une apophyse unciforme, rétracter l'apophyse unciforme, et ensuite éclairer le canal naso.frontal pour fournir une visualisation améliorée du canal naso-frontal.
PCT/US2015/049719 2014-09-12 2015-09-11 Support destiné à l'apophyse unciforme aux fins d'éclairage du canal naso-frontal WO2016040820A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/484,520 2014-09-12
US14/484,520 US9623213B2 (en) 2013-03-15 2014-09-12 Uncinate process support for ethmoid infundibulum illumination

Publications (1)

Publication Number Publication Date
WO2016040820A1 true WO2016040820A1 (fr) 2016-03-17

Family

ID=54197101

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/049719 WO2016040820A1 (fr) 2014-09-12 2015-09-11 Support destiné à l'apophyse unciforme aux fins d'éclairage du canal naso-frontal

Country Status (1)

Country Link
WO (1) WO2016040820A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018080769A1 (fr) * 2016-10-25 2018-05-03 Acclarent, Inc. Caractéristiques d'actionnement pour système de dilatation
US20210138127A1 (en) * 2018-07-23 2021-05-13 Nc8, Inc. Cellulite treatment system and methods

Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995005865A1 (fr) * 1993-08-24 1995-03-02 Solar Ronald J Catheter a dilatation avec ballon excentrique
US5718684A (en) * 1996-05-24 1998-02-17 Gupta; Mukesh Multi-lobed balloon catheter
US5836957A (en) * 1994-12-22 1998-11-17 Devices For Vascular Intervention, Inc. Large volume atherectomy device
US6245040B1 (en) * 1994-01-14 2001-06-12 Cordis Corporation Perfusion balloon brace and method of use
EP1477104A1 (fr) * 2003-05-16 2004-11-17 Ethicon Endo-Surgery Appareil médical pour une l'utilisation avec un endoscope
US20060271093A1 (en) * 2005-05-27 2006-11-30 Holman Thomas J Fiber mesh controlled expansion balloon catheter
US20080172033A1 (en) * 2007-01-16 2008-07-17 Entellus Medical, Inc. Apparatus and method for treatment of sinusitis
US20100030113A1 (en) 2008-07-30 2010-02-04 Acclarent, Inc. Paranasal Ostium Finder Devices and Methods
US20100030031A1 (en) 2008-07-30 2010-02-04 Acclarent, Inc. Swing prism endoscope
US20110004057A1 (en) 2004-04-21 2011-01-06 Acclarent, Inc. Systems and methods for transnasal dilation of passageways in the ear, nose or throat
WO2011106735A1 (fr) * 2010-02-26 2011-09-01 The Board Of Trustees Of The Leland Stanford Junior University Systèmes et procédés de création de valve endoluminale
US20120071856A1 (en) 2010-09-22 2012-03-22 Goldfarb Eric A Medical Device and Method for Treatment of a Sinus Opening
US20120078118A1 (en) 2010-09-24 2012-03-29 Thomas Jenkins Sinus illumination lightwire device
WO2013066566A1 (fr) * 2011-10-07 2013-05-10 W.L. Gore & Associates, Inc. Ensembles ballonnets présentant des topographies à variation contrôlable
WO2013119735A1 (fr) * 2012-02-08 2013-08-15 Tanhum Feld Structure de contrainte avec supports axiaux non linéaires
WO2014149431A2 (fr) * 2013-03-15 2014-09-25 Acclarent, Inc. Assistance au processus unciforme pour éclairage du canal naso-frontal

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995005865A1 (fr) * 1993-08-24 1995-03-02 Solar Ronald J Catheter a dilatation avec ballon excentrique
US6245040B1 (en) * 1994-01-14 2001-06-12 Cordis Corporation Perfusion balloon brace and method of use
US5836957A (en) * 1994-12-22 1998-11-17 Devices For Vascular Intervention, Inc. Large volume atherectomy device
US5718684A (en) * 1996-05-24 1998-02-17 Gupta; Mukesh Multi-lobed balloon catheter
EP1477104A1 (fr) * 2003-05-16 2004-11-17 Ethicon Endo-Surgery Appareil médical pour une l'utilisation avec un endoscope
US20110004057A1 (en) 2004-04-21 2011-01-06 Acclarent, Inc. Systems and methods for transnasal dilation of passageways in the ear, nose or throat
US20060271093A1 (en) * 2005-05-27 2006-11-30 Holman Thomas J Fiber mesh controlled expansion balloon catheter
US20080172033A1 (en) * 2007-01-16 2008-07-17 Entellus Medical, Inc. Apparatus and method for treatment of sinusitis
US20100030031A1 (en) 2008-07-30 2010-02-04 Acclarent, Inc. Swing prism endoscope
US20100030113A1 (en) 2008-07-30 2010-02-04 Acclarent, Inc. Paranasal Ostium Finder Devices and Methods
WO2011106735A1 (fr) * 2010-02-26 2011-09-01 The Board Of Trustees Of The Leland Stanford Junior University Systèmes et procédés de création de valve endoluminale
US20120071856A1 (en) 2010-09-22 2012-03-22 Goldfarb Eric A Medical Device and Method for Treatment of a Sinus Opening
US20120078118A1 (en) 2010-09-24 2012-03-29 Thomas Jenkins Sinus illumination lightwire device
WO2013066566A1 (fr) * 2011-10-07 2013-05-10 W.L. Gore & Associates, Inc. Ensembles ballonnets présentant des topographies à variation contrôlable
WO2013119735A1 (fr) * 2012-02-08 2013-08-15 Tanhum Feld Structure de contrainte avec supports axiaux non linéaires
WO2014149431A2 (fr) * 2013-03-15 2014-09-25 Acclarent, Inc. Assistance au processus unciforme pour éclairage du canal naso-frontal

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018080769A1 (fr) * 2016-10-25 2018-05-03 Acclarent, Inc. Caractéristiques d'actionnement pour système de dilatation
CN110072586A (zh) * 2016-10-25 2019-07-30 阿克拉伦特公司 扩张导管的致动特征部
US10512764B2 (en) 2016-10-25 2019-12-24 Acclarent, Inc. Actuation features for dilation system
US20210138127A1 (en) * 2018-07-23 2021-05-13 Nc8, Inc. Cellulite treatment system and methods
US11911555B2 (en) * 2018-07-23 2024-02-27 Revelle Aesthetics, Inc. Cellulite treatment system and methods

Similar Documents

Publication Publication Date Title
US10549076B2 (en) Uncinate process support for ethmoid infundibulum illumination
EP3528883B1 (fr) Système de dilatation
US9615959B2 (en) Uncinate process support for ethmoid infundibulum illumination
US10065028B2 (en) Enhanced gripping features for nasal and paranasal sinus systems
US20180104404A1 (en) Apparatus and method for irrigating sinus cavity
US10569060B2 (en) Guide catheters with guidewire deflection features
AU2016251632A1 (en) Guidewire with navigation sensor
US20140276654A1 (en) Nasal Suction Device
EP3285847A1 (fr) Système de dilatation à ballonnet avec guide malléable interne
US9757018B2 (en) Medical guidewire with integral light transmission
US10987497B2 (en) Balloon catheter with tactile feedback features and reinforced lumen
WO2019102340A1 (fr) Cathéter de guidage pour système de dilatation
JP2018515168A (ja) 光センシングを備える照明ガイドワイヤ
US9872973B2 (en) Luer members for coaxial lumen catheter
WO2016040820A1 (fr) Support destiné à l'apophyse unciforme aux fins d'éclairage du canal naso-frontal
EP3801726B1 (fr) Cathéter de dilatation à pointe d'ampoule amovible
KR20210113223A (ko) 공동 확장
KR20190024820A (ko) 복수의 구성을 갖는 부비동성형 가이드

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15770737

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 15770737

Country of ref document: EP

Kind code of ref document: A1