WO2018146694A1 - Cathéter de sinuplastie - Google Patents

Cathéter de sinuplastie Download PDF

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Publication number
WO2018146694A1
WO2018146694A1 PCT/IN2017/050160 IN2017050160W WO2018146694A1 WO 2018146694 A1 WO2018146694 A1 WO 2018146694A1 IN 2017050160 W IN2017050160 W IN 2017050160W WO 2018146694 A1 WO2018146694 A1 WO 2018146694A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
distal end
inner tube
outer tube
sinus
Prior art date
Application number
PCT/IN2017/050160
Other languages
English (en)
Inventor
Chiragkumar Sumantrai PATEL
Dr. Pramodkumar MINOCHA
Original Assignee
Meril Life Sciences Pvt Ltd
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 Meril Life Sciences Pvt Ltd filed Critical Meril Life Sciences Pvt Ltd
Publication of WO2018146694A1 publication Critical patent/WO2018146694A1/fr

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Classifications

    • 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

  • the present disclosure relates generally to medical devices, and more particularly to dilation instruments.
  • Paranasal sinus includes four paired air filled spaces namely Frontal sinus, Ethmoid sinus, Sphenoid sinus and Maxillary sinus surrounding the nasal cavity.
  • the paranasal sinus is lined with mucous producing epithelial tissue. Mucous produced by the epithelial tissue slowly drains out of sinus through an opening known as an ostium. I nflammation of the ep ithelial tissue of the passageways may block the cavities through which mucous is d rained out leads to a condition known as sinusitis.
  • the term "sinusitis” refers generally to any inflammation or infection caused by bacteria, viruses, fungi (molds), allergies or combinations thereof.
  • One of the ways to treat sinusitis is to use drugs such as anti-inflammatory drugs or antibiotics.
  • drugs such as anti-inflammatory drugs or antibiotics.
  • Other way to treat sinusitis is to open paranasal sinus via surgery.
  • One of such surgeries is functional endoscopic sinus surgery (FESS).
  • FESS can cause significant post-operative pain as some FESS procedures are associated with significant post-operative bleeding and, as a result, nasal packing is frequently placed in the patient's nose for some period of time following the surgery. Such nasal packing can be uncomfortable and can interfere with normal breathing, eating, drinking etc.
  • Another technique to treat sinusitis is by using balloon sinuplasty.
  • a dilatation catheter such as a balloon catheter or other type of dilator is advanced through the nose or some other entry path into a patient's nose to a position within the ostium of a paranasal sinus or other location, without requiring removal or surgical alteration of other intranasal anatomical structures.
  • the dilatation catheter is then used to dilate the ostium or other anatomical structures.
  • a tubu lar guide such as a guide tube may be initially inserted thro ugh the nose and advanced to a position near the sinus ostium, to reach the affected paranasal sinus.
  • introduction of the tubular guide may result in repeated intrusion of devices into the patient's paranasal cavity and may correspondingly result in increased tissue trauma, increased postoperative recovery time, and/or increased surgery time (and thus cost) involved in the procedure.
  • the catheter may be a balloon catheter used in sinuplasty.
  • the catheter includes an outer tube having a distal end and a proximal end, the outer tube comprising a plurality of holes towards the distal end; an inner tube coaxially placed with the outer tube, the inner tube comprises a rigid material, the inner tube having a distal end and a proximal end, the distal end of the inner tube permanently attached to the distal end of the outer tube; and an expandable member mounted completely towards the distal end of the outer tube and enclosing the plurality of holes, thereby eliminating the need for a guidewire.
  • the catheter of the above construction is a single-piece device in which the various components are fixed and not movable with respect to each other.
  • FIG. 1 illustrates a two dimensional cross-sectional view of a balloon catheter in accordance with an embodiment of the present invention.
  • FIG. 2 illustrates a perspective view of a balloon catheter in accordance with an embodiment of the present invention.
  • FIG. 3 illustrates a flow chart depicting insertion of a balloon catheter into sinus in accordance with embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • a dilation instrument with navigational capabilities for dilating an opening of a paranasal sinus in a human or animal subject.
  • the term opening of a paranasal sinus as used herein shall, unless otherwise stated, include any and all trans-nasally accessible opening in a paranasal sinus or air cell including but not limited to; natural ostia, surgically altered natural ostia, surgically created openings, antrostomy openings, ostiotomy openings, burr holes, drilled holes, ethmoidectomy openings, natural or man-made passageways, etc.
  • FIG. 1 illustrates a cross-sectional view of a catheter 100 which includes an outer tube 10, an inner tube 20, an fiber optic cable 30, an expandable member 40, one or more markers 50, an atraumatic tip 60, and a rigid tube 70.
  • the outer tube (or flexible shaft) 10 has a proximal end 12 and a distal end 14 with a lumen 16 extending from the proximal end 12 to the distal end 14 to provide a passage way for components like inner tube 20.
  • the outer tube 10 may be made of a flexible polymer such as nylon, plutonium, High-density polyethylene (HDPE), pebax, etc.
  • the outside diameter of the outer tube 10 may range from 1.5 mm to 2 mm with a wall thickness ranging from 0.125 to 0.3 mm in accordance with the paranasal anatomy of a patient.
  • the outer tube includes an antifungal and/or antibacterial coating.
  • a multi-sectional outer tube can also be used in place of the single section outer tube 10 as described in the present disclosure.
  • the inner tube 20 has a proximal end 22 and a distal end 24.
  • the inner tube is positioned coaxially within the outer tube 10 of the catheter 100.
  • the inner tube 20 is an elongated body with a lumen 26 extending from the proximal end 22 to the distal end 24.
  • the inner tube 20 can be a stainless steel hypotube.
  • the inner tube 20 can be made of nitinol, titanium and/or other shape memory alloy. The shape memory alloy enables the inner tube 20 to remember its previous shape if deformed.
  • the outer diameter of the inner tube 20 may range from 1.22 mm to 1.56 mm with a wall thickness ranging from 0.16 to 0.6 mm.
  • the distal end 24 of the inner tube 20 may have a fixed predefined angle with respect to the proximal end 22.
  • the distal end 24 of the inner tube 20 may be malleable to bend it with the help of a guiding tool to achieve a required angle for treatment of various sinuses like frontal, ethmoid, maxillary and sphenoid.
  • the angulation of the distal end 24 of the inner tube 20 is customized based upon nasal anatomy for various sinuses. As an example, the front part is curved approximately 60-80°C for frontal sinus, 0-30°C for sphenoid sinus, and 85-135°C for maxillary sinus, etc.
  • the inner tube 20 includes an illumination means in its lumen 26 such as, a fiber optic cable 30 that extends fully through the lumen 26. Towards the distal end, the fiber optic cable 30 may attain the curvature of the distal end 24 of the inner tube 20.
  • the inner tube 20 is configured to receive light from a light source through the fiber optic cable 30.
  • the fiber optic cable 30 within the catheter 100 can be configured movable along the length of the inner tube 20 or may be fixed at the proximal end of the catheter 100.
  • the expandable member (or dilation member) 40 such as a balloon is provided over the outer tube 10 to dilate the sinus.
  • the expandable member 40 may be entirely mounted on the outer tube 10.
  • the expandable member 40 may be made of materials such as PET, POC, HDPE or preferably polyether block amide (PEBAX) of a predefined diameter ranging from 3 mm to 8 mm according to the nasal anatomy of a patient.
  • PEBAX polyether block amide
  • the expandable member 40 may have a proximal neck 42, distal neck 44 and a middle portion 46. Both, the proximal neck 42 and the distal neck 44 are mounted over the outer tube 10 towards distal end 14 of the outer tube 10 by means of for example, thermal bonding using adhesives preferably urethane or any other suitable means.
  • the outer tube 10 is provided with a plurality of holes 18 in the region where the expandable member 40 is mounted. These holes 18 are enclosed by the middle portion 46 of the expandable member 40. Holes 18 on the outer tube 10 can be either circular or non-circular in shape. Holes 18 may be arranged in the form of an array on the outer tube 10 or may be arranged randomly. The holes 18 are provided to inflate or deflate the expandable member 40 during treatment of inflamed sinus by injecting or retrieving a fluid (for example, saline) from the lumen 16 of the outer tube 10.
  • a fluid for example, saline
  • Several position indicators/ markers 50 are provided over the outer tube 10 for adequate positioning of the catheter 100.
  • the markers can be of platinum-lridium alloy or radiopaque materials.
  • the method of securing a marker on the outer tube 10 can be by way of adhesion, swagging or cold forging process, etc.
  • the markers 50 are secured on the outer tube 10 by means of printing.
  • Each marker band may have a length ranging from 1 mm to 5 mm.
  • the atraumatic tip 60 may be a soft polymer material attached at the distal end 14 of the outer tube 10.
  • the outer tube 10, the inner tube 20 and the atraumatic tip 60 may be heat welded at the end of the catheter 100 to close the distal end of the catheter 100.
  • the catheter 100 includes a rigid tube 70.
  • the rigid tube 70 has a proximal end 72 and a distal end 74. A portion of the outer tube 10 is positioned coaxially within the rigid tube 70 of the catheter 100.
  • the rigid tube 70 is an elongated body with a lumen 76 extending from the proximal end 72 to the distal end 74.
  • the rigid tube 70 can be made of an alloy preferably stainless steel and is used to provide stiffness for easy handling of the catheter 100.
  • FIG. 2 illustrates a perspective view of the catheter 100 of FIG. 1 with a multi-port hub 80, for example, a two-port hub.
  • the rigid tube 70 is connected with the two port hub 80 at its proximal end 72.
  • the two port hu b 80 typically includes a guiding port 82 and an inflation port 84, Guiding port 82 communicates with the inner !umen 26 of the inner tube 20 which in turn can be provided with a passage for the fibre optic cable 30 as shown in FIG. 1.
  • the inflation port 84 is in fluid communication with the annular lumen 16 between the inner tube (not shown) and the coaxially disposed outer tube 10 which in turn is in fluid commu nication with the interior of the expandable member 40.
  • FIG. 3 illustrates a flow chart depicting the process of operation of the catheter 100 in accordance with an embodiment of the present invention.
  • a catheter includes one or more sinus dilation instruments.
  • the instrument is sized and shaped for locating a balloon carried thereby at a particular targeted sinus region (e.g., frontal sinus, maxillary sinus, or sphenoid sinus) via a patient's naris or alternatively sized and shaped for accessing the targeted sinus region through other conventional approaches such as canine fossa or open approach.
  • the expandable member 40 is selectively fluidly connected to the catheter 100 via the inflation port 84. With this construction, use of the catheter 100 in treating the paranasal, maxillary sinus etc.
  • the process of operating the catheter commences at the step 101 wherein the catheter is inserted into a blocked nasal passage or nasal ostium. The catheter is aligned with respect to the blocked nasal passage as desired. After accurate alignment of the catheter in the nasal passage, the inflation port 84 is operated to inflate the expandable member 40.
  • a fluid say, saline
  • the inflation port 84 is operated to inflate the expandable member 40.
  • a fluid is passed through the inflation port 84 that traverses the entire length of the lumen 16 of the outer tube 10.
  • the fluid passes from the holes 18 into the area enclosed between the outer tu ber 10 and the expandable member 40.
  • the amount of fluid to be passed can be controlled at the inflation port and may vary due to several factors, like the amount of inflation of the expandable member desired, etc.
  • the expandable member 40 Once the expandable member 40 is inflated, it causes expansion of the sinus ostiu m or other region of the accessed sinus as required . In other words, the inflated expandable member 40 causes the sinus opening to expand by restructuring and widening the walls of the sinus passageway while maintaining the integrity of the sinus lining.
  • the inflation port is 84 is further operated to deflate the balloon at the step 105.
  • the fluid is withd rawn from the expandable member 40 with the help of inflation port 84.
  • Techniques used for withdrawing the fluid may include suction etc.
  • the catheter 100 having deflated expandable member 40 is removed leaving the nasal passage widened at the step 107. Infected mucus etc. present inside the blocked sinus may thereafter drain or be removed using an external device.
  • the fibre optic cable 30 may be inserted after the catheter 100 is placed in order to accurately place the catheter inside the nasal ostium.
  • the fibre optic cable 30 is inserted into the nasal ostium together with the catheter 100.
  • a surgeon may move the catheter as required during placement for illumination of the nasal ostiu m via the cable 30.
  • the system includes two or more of the sinus dilation instruments, each sized and shaped for accessing a different sinus region of a patient (via an intranasal approach). Once the surgeon has determined the paranasal sinus to be treated, the surgeon selects the appropriately sized and shaped sinus dilation instrument, optically connects the selected instrument and then performs the procedure as outlined above.
  • the whole catheter assembly 100 is bounded within the handle as an integrated single unit or single piece.
  • guide catheter is initially inserted into the nose followed by a guide wire through the guide catheter, a balloon catheter is then passed over the guide wire.
  • the present invention discloses a catheter with a single or an integrated assembly. The features disclosed in the present invention eliminate the need of using separate wires, thereby making the whole process of treatment extremely simplified for doctors. It reduces the time of operation of appliance as it can be delivered to the patient in short time.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne notamment un cathéter de sinuplastie à ballonnet pour le traitement de la sinusite chronique. Le cathéter à ballonnet de la présente invention est un ensemble fixe qui est facile à construire et peut être administré à un patient en une seule opération, ce qui évite toute lésion du revêtement épithélial du tissu nasal.
PCT/IN2017/050160 2017-02-13 2017-05-04 Cathéter de sinuplastie WO2018146694A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201721005105 2017-02-13
IN201721005105 2017-02-13

Publications (1)

Publication Number Publication Date
WO2018146694A1 true WO2018146694A1 (fr) 2018-08-16

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PCT/IN2017/050160 WO2018146694A1 (fr) 2017-02-13 2017-05-04 Cathéter de sinuplastie

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WO (1) WO2018146694A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11331460B1 (en) 2015-01-19 2022-05-17 Dalent, LLC Dilator device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090088728A1 (en) * 2007-09-28 2009-04-02 Dollar Michael L Malleable sleeve for balloon catheter and endoscopic surgical method
US20170000991A1 (en) * 2015-06-30 2017-01-05 Acclarent, Inc. Balloon catheter with tactile feedback features and reinforced lumen

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090088728A1 (en) * 2007-09-28 2009-04-02 Dollar Michael L Malleable sleeve for balloon catheter and endoscopic surgical method
US20170000991A1 (en) * 2015-06-30 2017-01-05 Acclarent, Inc. Balloon catheter with tactile feedback features and reinforced lumen

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11331460B1 (en) 2015-01-19 2022-05-17 Dalent, LLC Dilator device

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