WO2023168123A1 - Cathéter de dilatation à ballonnet - Google Patents

Cathéter de dilatation à ballonnet Download PDF

Info

Publication number
WO2023168123A1
WO2023168123A1 PCT/US2023/014640 US2023014640W WO2023168123A1 WO 2023168123 A1 WO2023168123 A1 WO 2023168123A1 US 2023014640 W US2023014640 W US 2023014640W WO 2023168123 A1 WO2023168123 A1 WO 2023168123A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
shape
airway
inflated
stenosis
Prior art date
Application number
PCT/US2023/014640
Other languages
English (en)
Inventor
Andrew J. GEORGILIS
Original Assignee
Bryan Medical Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bryan Medical Inc. filed Critical Bryan Medical Inc.
Publication of WO2023168123A1 publication Critical patent/WO2023168123A1/fr

Links

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
    • 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
    • A61M25/1027—Making of balloon catheters
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1059—Balloon catheters with special features or adapted for special applications having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties

Definitions

  • the present invention relates to medical care equipment and procedures for relieving a stenosis or deploying a stent into a patient.
  • the invention relates to a balloon catheter device for performing dilation of strictures of the patient's airway, including the larynx, trachea or bronchi, vascular system, esophagus, or other areas of the body needing such treatment.
  • the pediatric patient with subglottic stenosis is a neonate in the intensive care unit who has failed extubation, usually multiple times. Occasionally patients will present in clinic with a tracheotomy and the report of some airway obstruction. Infants with mild subglottic stenosis may present with recurrent croup-like illnesses and poor feeding. Adults usually have a history of prior intubation with symptoms of progressive shortness of breath and noisy breathing.
  • Airway balloon dilation has been shown to be a safe and effective palliative procedure for treatment of mild congenital and acquired stenosis of the trachea and bronchi. Dilation of luminal human anatomy to treat stenosis can be dated back to the 16th Century with esophageal “bougie” dilation. Specific medical applications of luminal balloon dilation range from alimentary canal and airway dilation to dilation of the vasculature. Airway dilation dates back over 100 years ago with the invention and subsequent use of the first beveled rigid bronchoscopes for stricture management.
  • Airway balloon dilation can be used to quickly re-establish tracheal or bronchial luminal patency to restore airflow in a way that doesn't cause excessive trauma to the patient.
  • Literature has reported the use of balloon dilation for the treatment of benign strictures of the airway.
  • Fibrotic strictures such as those secondary to tuberculosis, long-term endotracheal or tracheostomy tube placement, berylliosis, Wegener's granulomatosis, or sarcoidosis have been shown to be treatable with airway balloon dilation therapy with general success. Additionally, balloon dilation has been useful in treating strictures secondary to major surgical interventions such as lung transplantation, sleeve resection, bronchial re-implantation, and lobectomy. For the purpose of treating strictures secondary to malignant obstruction, dilation therapy can be used alone or in combination with other techniques such as surgical resection, cryotherapy, laser therapy, and stent placement, depending on the desired outcome for the patient.
  • Treatment with airway dilation can involve the clinician inserting increasingly larger tubes into the airway (e.g. endotracheal tubes or cat-tail (bougie) dilators), which creates significant shear forces on the airway mucosa.
  • tubes e.g. endotracheal tubes or cat-tail (bougie) dilators
  • endotracheal tubes or cat-tail (bougie) dilators e.g. endotracheal tubes or cat-tail (bougie) dilators
  • a procedure sometimes induces unwanted trauma to the airway in the form of deep lacerations and hemoptysis.
  • current dilation practices do not permit dilation of a tracheal stenosis that is distal to a narrowing of the proximal airway (i.e. a mild subglottic stenosis).
  • angioplasty balloons are typically carried out using angioplasty balloons; however, several limitations to the use of angioplasty balloons become evident when used on the airway. For example, it may be difficult to adequately ventilate the patient during the dilation period, since the typical angioplasty balloon does not include a connection to an oxygen source. Further, the shape of the angioplasty balloon may predispose the balloon to slide out of place during dilation, or the balloon may be limited to the amount of pressure that can be applied before the balloon bursts. Also, the typical angioplasty balloon can usually stretch the airway lumen but not permanently dilate it.
  • U.S. Patent No. 7,771,446 provides a balloon dilator for the airway of a patient that is able to allow ventilation of the patient during balloon inflation, as well as provides increased inflation pressures during balloon dilation of the airway.
  • the balloon dilator is capable of deploying a stent in a patient at the site of a stenosis by utilizing an inflatable outer dumbbell-shaped balloon that will not slip out of place in the patient's airway or other body lumen during balloon inflation.
  • the balloon is prevented from slippage by inflating at either end (i.e. on either side of the stenosis) before the central section inflates, thereby allowing the central section of the outer balloon to stay in position over the stenosis during inflation.
  • the proximal and distal ends of the outer balloon inflate first, thereby forming the "dumbbell" shape, and as a result, trapping the stenotic airway segment at the central portion of the balloon. Then, as the pressure in the balloon is increased, the central portion of the balloon fully inflates at the site of the stenosis.
  • the dilator of U.S. Patent No. 7,771,446 also includes one or more inner balloons that allow higher dilation pressures to be generated from inside the outer balloon.
  • the inner balloons are contained inside the outer balloon and are simultaneously inflatable within the outer balloon.
  • at least one inner balloon inside the outer balloon is capable of inflating separately from the outer balloon.
  • an apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient includes a single lumen catheter having a proximal end and a distal end and a high pressure balloon attached to the distal end of the catheter.
  • the high pressure balloon is fabricated from a semi-compliant material having an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and exhibiting either a dumbbell-shaped outer periphery or an offset-shaped outer-periphery when inflated to a first atmospheric pressure and exhibits a substantially linear outer periphery when inflated to a second atmospheric pressure that is greater than the first atmospheric pressure.
  • FIG. 1 represents a perspective view of an illustrative balloon dilation catheter device in accordance with one aspect of the present invention.
  • FIG. 2 represents a perspective view of an illustrative high pressure balloon that has been inflated to approximately 2 ATM in accordance with one illustrative aspect of the present invention.
  • FIG. 3 represents a side view of the illustrative high pressure balloon of FIG. 2.
  • FIG. 4 represents a perspective view of the illustrative high pressure balloon of FIG. 2 inflated to approximately 17 ATM in accordance with one illustrative aspect of the present invention.
  • FIG. 5 represents a side view of the illustrative high pressure balloon of FIG. 4.
  • FIG. 6 represents a side view of the illustrative high pressure balloon dilatation catheter device in accordance with one aspect of the present invention.
  • the present invention provides an apparatus for performing a balloon dilation catheter procedure at the site of a stenosis or for deploying a stent in a patient.
  • the balloon dilation catheter procedure can be used for treating any stenosis or area in need of a stent in a patient, as well as for performing dilation of a lumen in a patient's larynx, trachea or bronchi, vascular system, esophagus, or other areas of the body.
  • the balloon dilation catheter includes a single lumen catheter with an inflatable high pressure balloon near the distal tip.
  • the balloon dilation catheter is insertable into a patient to a desired location with the assistance of a stylet. Once the balloon is inserted to the desired location within the patient, the stylet can then be removed and the high pressure balloon inflated from its deflated configuration.
  • a luer lock at the proximal end of the catheter shaft is used for placement of the stylet and for injecting sterile water into the balloon.
  • radiopaque markers can also be located on the catheter inside the balloon to confirm the balloon placement under fluoroscopy.
  • the apparatus comprises a balloon that when deflated has a narrow diameter, but inflates in a dumbbell shaped fashion (i.e., the outer periphery of the balloon exhibits a dumbbell shaped configuration) whereby the proximal and distal aspects of the balloon inflate before the central aspect of the balloon.
  • a dumbbell shaped fashion i.e., the outer periphery of the balloon exhibits a dumbbell shaped configuration
  • This can be achieved by utilizing a semi-compliant balloon that exhibits shape memory properties, as well as by providing the central half of the balloon with a greater wall thickness than the proximal and distal portions of the balloon.
  • the advantage of this configuration is that once the balloon is inflated across a stenosis, the proximal and distal portions of the balloon inflate prior to the central section. Because the proximal and distal portions inflate first, the balloon develops hubs at those respective regions, which in turn, encourages the balloon to be held in place proximate the stenosis and thereby prevented from slipping during the remainder of the inflation process. As pressure inside the balloon increases, the central aspect of the balloon eventually inflates, thereby expanding the stenosis. When the balloon is fully inflated, the outer periphery of the balloon develops a substantially linear shape exhibiting a uniform diameter from its proximal end to its distal end.
  • the device can also be used to place and deploy an expandable stent within a targeted anatomical region of a patient.
  • a stent is placed over the central aspect of the balloon, and once the proximal and distal portions of the balloon are inflated, the stent is then locked into position over the central aspect of the balloon.
  • the apparatus comprises a single chamber high pressure balloon 12 that is attached to a single lumen catheter 14 at its distal tip.
  • a stylet 16 is provided to facilitate advancement of the balloon dilation catheter 10 to a desired location within a patient.
  • the stylet 16 is removed before inflation of the high pressure balloon 12.
  • a central lumen 18 extends longitudinally throughout the catheter 14 and has a distal end 20 fixedly attached to the distal end of the balloon 12, while the proximal end 22 of the central lumen 18 terminates into a luer lock 24, which is in turn used to place the stylet 16 and for injecting sterile water into the balloon 12.
  • the central lumen 18 of the catheter 14 serves as the inflation lumen for the balloon 12, and as such, is configured to be filled with saline or water to thereby achieve a desired level of atmospheric inflation pressure within the balloon. It should be understood and appreciated that the amount of atmospheric pressure placed into the balloon will be influenced by and depend upon the size of the balloon being utilized.
  • the atmospheric pressure is generally between about 14 and about 19 atmospheres (atm) of pressure, and more particularly about 17 atmospheres (atm) of pressure.
  • the atmospheric pressure is generally between about 8 and about 12 atmospheres (atm) of pressure, and more particularly about 10 atmospheres (atm) of pressure.
  • the stylet 16 is slidably positioned through the catheter 14 during a dilation procedure to advance the catheter within an airway or targeted anatomical passageway (e.g., at a stenosis site).
  • the balloon 12 may then be actuated to an expanded state to open or dilate the targeted anatomical passageway and then deflated back to a collapsed state once the dilation procedure is completed.
  • the balloon dilation catheter 10 in accordance with certain embodiments, may include some form of indicia 25 if desired.
  • the balloon dilation catheter can include one or more indicia 25 that are viewable under either fluoroscopy or via direct visualization procedures, such as through an endoscope.
  • the indicia 25 can be placed on the catheter 14 relative to one or more sections of the balloon and can be made of a radiopaque material to assist the technician in positioning the balloon 12 under a fluoroscope. Radiopaque materials are known within the art and may include, but are not necessarily limited to, gold, platinum, or tantalum.
  • radiopaque materials can also be applied to or deposited on the surface of the catheter 14, and can include, for instance, ink, paint, or polymer containing barium or tantalum, etc.
  • the balloon catheter 14 may have any number of suitable sizes, shapes and configurations.
  • the balloon 12 may also have different lengths and diameters to accommodate different patient anatomies. Accordingly, it should be understood that the various dimensions and configurations provided herein are only intended to be illustrative in nature and should not be perceived as limiting the teachings of the present invention.
  • the overall length of the balloon catheter 14 i.e., from the proximal end 22 to the distal end 20 of the catheter shaft 14
  • the overall length of the balloon catheter 14 may be around 53 cm (or around 55 cm when also including the length of the luer lock together with the catheter shaft).
  • the term “working length” is intended to refer to the portion of the balloon 12 that exhibits a linear (i.e., non-hubbed) shape when inflated to an atmosphere pressure between about 1 and 6 atmospheres (atm).
  • this linear portion of the balloon refers to the central area or portion 38 of the balloon that is between the proximal and distal end (hubbed) portions 34, 36 of the balloon that interfaces and dilates the stricture upon full inflation.
  • the working length of the balloon 12 will be influenced by and depend upon the size of the balloon being utilized. For instance, in accordance with certain aspects herein when the balloon size is between about 5 and about 10 mm, the working length of the balloon 12 may be about 30 mm.
  • the working length of the balloon 12 may be about 40 mm.
  • Table 1 illustrates various nonlimiting balloon dilation catheter and balloon sizes and corresponding characteristics in accordance with certain aspects of the present invention.
  • the balloon dilation catheter 10 Prior to use, the balloon dilation catheter 10 is provided in sterile packaging and with a protective sheath covering the balloon 12. After removing the catheter 14 from the packaging and protective sheath, it is wiped down with a gauze pad soaked in sterile water. The catheter 14 is then gently advanced into the airway of a patient and to the site of the stricture under endoscopic visualization. The balloon 12 portion of the device 10 is then centered across the restriction and the stylet 16 is removed while holding the catheter 14 securely in place. The balloon dilation catheter luer 24 is attached to the inflation device (not shown) and the balloon 12 is inflated to a desired pressure with sterile water.
  • the balloon 12 is monitored during the inflation process via endoscopy to assess the diameter, shape, and position of the balloon so that it can be ensured that the proximal end 22 of the balloon remains proximate to the stricture.
  • the balloon is then completely deflated using a vacuum. Before the balloon 12 is removed from the airway, a visual confirmation can be made to verify that the balloon 12 is fully deflated. If additional inflations are required, the balloon 12 can be gently re-wrapped and compressed starting at the distal end as a vacuum is applied.
  • medical balloons are generally referred to as compliant, non-compliant and semi-compliant.
  • balloon compliance is a term used to describe the change in a balloon's diameter as a function of pressure.
  • Low pressure compliant medical balloons are typically formed from elastomers such as latex, polyurethane and other thermoplastic elastomers and may expand by 100% or greater upon inflation.
  • Compliant medical balloons are typically used for fixation and occlusion.
  • High pressure non-compliant dilation balloons expand very little, if at all, when pressurized from a nominal diameter to a rated burst pressure.
  • the rated burst pressure of a medical balloon refers to the maximum pressure at which there is a statistical 95% confidence level that 99.9% of the population of balloons will not burst.
  • high pressure non-compliant balloons may have rated burst pressures of up to 20 atmospheres or higher and are formed from relatively inelastic materials, such as polyethylene terephthalate (PET) films, which provide high tensile strength and may be used to form balloons with thin walls having high burst pressures.
  • PET polyethylene terephthalate
  • Semi-compliant medical balloons exhibit a moderate degree of expansion when pressurized from an operating pressure (e.g., the pressure at which the balloon reaches its nominal diameter) to its rated burst pressure.
  • an operating pressure e.g., the pressure at which the balloon reaches its nominal diameter
  • semi-compliant balloons are less stiff and provide better puncture resistance qualities.
  • the tensile strength of semi-compliant medical dilation balloons is typically less than that of non-compliant balloons.
  • dilation balloons formed from semi-elastic materials typically must be fabricated with thicker walls in order to achieve the same burst pressures as the non-compliant balloons. By having a thicker wall, the diameter of the balloon catheter assembly and the size of the introducer used to introduce the semi-compliant balloon as part of the dilation procedure must also be increased.
  • the high pressure balloon 12 is formed from a semi-compliant material and has a rated burst pressure of up to about 27 atmospheres (atm).
  • a rated burst pressure of up to about 27 atmospheres (atm).
  • Table 2 shows exemplary test data of various rated burst pressures of balloons as a function of balloon size and diameter and at recommended use pressures in accordance with the present teachings.
  • the standard deviation of the rated burst pressures in accordance with these illustrative examples, is a measure of the consistency of the burst pressure over about 40 different tests.
  • the present invention provides a balloon that is safer and has improved treatment efficacy as compared to other conventional medical dilation balloons within the industry. More particularly, unlike conventional balloons, the balloon of the present invention has a recommended inflation pressure and rated/tested burst pressure that is not only unique, but also inflates (i.e., has an expansion curve ratio) that is much more consistent than compliant balloon structures.
  • an illustrative high pressure balloon 12 is illustrated at less than 2 ATM of inflation.
  • the balloon 12 has an external surface 26 that is dumbbell or dog bone shaped. More particularly, and as will be explained in greater detail below, the balloon 12 is configured to have a segmented dumbbell shape during the inflation process, such that, prior to reaching maximum inflation, the proximal 34 and distal 36 portions of the balloon have a larger diameter than the central section 38 of the balloon.
  • a semi-complaint shape memory polymer can be used that is capable of allowing the proximal 34 and distal 36 ends of the balloon to inflate before the central portion 38 of the balloon inflates.
  • a “shape memory polymer” refers to a polymeric material whose qualities have been altered to give them dynamic shape memory properties.
  • polymers possessing shape memory properties through the use of stimuli, can exhibit radical changes between rigid and elastic polymeric states.
  • the stored mechanical energy attained during the reconfiguration of these materials allows the memory or recovery qualities of these polymers to be exhibited.
  • the shape memory polymer that is used to form the balloon 12 is a nylon material.
  • a semi-compliant polyamide (nylon) balloon is blow molded in such a manner that the hub-like portions of the balloon are memory shaped into the structure. More particularly, as should be appreciated herein, the properties associated with the polyamide (nylon) material exhibit a specific expansion limitation feature, such that during the blow molding process, the proximal 34 and distal 36 portions of the balloon can be stretched to their maximum expansion limits, while leaving the central section 38 not expanded to such a degree.
  • the balloon is able to develop a hub-like feature that is memory shaped into the balloon structure. Accordingly, when the balloon 12 is deployed within a patient as part of a dilation process, the proximal 34 and distal 36 portions recover, when begin inflated, to their memory shaped expansion limitation features before the central section, thereby creating a dumbbell-shaped outer periphery that is defined by the two hub-like features at the respective locations of the proximal 34 and distal 36 regions. As the atmospheric pressure increases, the outer diameter of the central section 38 eventually matches the outer diameter of the hub-like portions, thereby creating an outer periphery for the balloon 12 that is substantially linear in shape (i.e., exhibits a uniform outer diameter across the entire balloon).
  • the balloon 12 may also be formed such that the proximal 34 and distal 36 ends have a decreased balloon wall thickness as compared to the central section 38 of the balloon, which may have an increased balloon wall thickness.
  • the wall thickness of the balloon 12 will be influenced by and depend upon the size of the balloon being utilized. For instance, in accordance with certain aspects in which the balloon size is 8 mm, the wall thickness at the central section 38 is about 0.0020 inches and the wall thickness at the proximal 34 and distal 36 ends is about 0.0017 inches.
  • the wall thickness at the central section 38 is between about 0.0022 inches and about 0.0023 inches, while the wall thickness at the proximal 34 and distal 36 ends is between about 0.0019 inches and about 0.0020 inches.
  • the proximal and distal end portions 34, 36 take the shape of dumbbell like hubs that in turn contact the surface of the airway and thereby cause the balloon 12 to be held into place proximate the stenosis site.
  • the proximal 34 and distal 36 ends of the balloon 12 inflate first, forming the "dumbbell" shape, and thereby trapping the stenotic airway segment at the central portion 38 of the balloon 12, so that the balloon 12 does not slip out of position.
  • the central portion 38 of the balloon fully inflates at the site of the stenosis.
  • FIGS. 4-5 show a balloon 12 that has been inflated to approximately 17 ATM and in which the central portion 38 has now been fully inflated and exhibits a substantially linear outer periphery.
  • the balloon dilation procedure is typically performed at the site of a stenosis in the airway of a patient (i.e. the larynx, trachea or bronchi).
  • the surgeon or clinician inserts the balloon dilation catheter 10 into the airway until the balloon 12 is positioned across the stenosis.
  • the surgeon or clinician inflates the balloon 12 to cause and allow the external surface 26 of the balloon 12 to expand upon and dilate the stenosis.
  • the balloon is typically inflated for about 30 to about 120 seconds. It should be understood and appreciated herein that repeat inflation-deflation cycles can be performed if airway narrowing remains after the initial dilation attempt.
  • the size of the balloon is first selected by the clinician, which depends upon the size of the stenosis in the patient's airway. As is explained above in accordance with certain aspects herein, the balloon size may be between about 30 mm and about 40 mm in length.
  • the balloon 12 is positioned over the stenosis and then dilated to the desired pressure with a balloon pump, typically to between about 14 and about 19 atmospheres (atm) for balloons sized between about 5 and about 10 mm, and between about 8 and about 12 atmospheres (atm) for balloons sized between about 12 and about 16 mm.
  • the balloon is deflated and the clinician determines if repeat inflation is necessary. Repeat inflation can be safely performed if there is no obvious trauma to the airway.
  • the invention may include an apparatus 60 for performing an airway balloon dilation procedure at the site of a stenosis in the airway of a patient adjacent to vocal cords.
  • the apparatus 60 may comprise a balloon 12 that when deflated has a narrower diameter than when the balloon 12 is inflated.
  • the proximal 70 and distal 72 aspects of the balloon 12 may inflate before the central aspect of the balloon 12. This may be achieved by utilizing a semi-compliant balloon 12 that exhibits shape memory properties, as well as by providing the central half of the balloon 12 with a greater wall thickness than the proximal 70 and distal 72 portions of the balloon 12.
  • One advantage of this configuration may be that once the balloon 12 is inflated across a stenosis, the proximal 70 and distal 72 portions of the balloon 12 inflate prior to the central section. Because the proximal 70 and distal 72 portions inflate first, the balloon 12 develops hubs at those respective regions, which in turn, encourages the balloon 12 to be held in place proximate the stenosis and thereby prevented from slipping during the remainder of the inflation process. As pressure inside the balloon 12 increases, the central aspect of the balloon 12 eventually inflates, thereby expanding the stenosis. When the balloon 12 is fully inflated, the outer periphery of the balloon 12 may develop a substantially linear shape exhibiting a uniform diameter from its proximal end 70 to its distal 72 end.
  • the first shape 62 When inflated to the first atmospheric pressure, the first shape 62 may have a substantially rounded cross-section from the central portion to the single lumen catheter.
  • the second shape 64 may have a substantially conical cross-section from the central portion to the single lumen catheter when inflated to the first atmospheric pressure.
  • the first shape 62 of the proximal end 70 may have a first longitudinal length 66 that is less than a second longitudinal length 68 of the second shape 64 of the distal end 72.
  • the first and second shapes 62, 64 may be advantageous when inflated to the first atmospheric pressure, because it may allow the apparatus 60 to be located in close proximity to the vocal cords. More specifically, the second longitudinal length 68 and the conical crosssection of the second shape 64 may allow the second shape to be located in a closer proximity to the vocal cords than would an apparatus with a non-conical cross section of a second shape 64.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments
  • Spatially relative terms such as “inner,” “outer,” “beneath”, “below”, “lower”, “above”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations).

Landscapes

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

Abstract

La présente divulgation concerne un procédé de fabrication d'un dispositif destiné à effectuer une procédure de dilatation par ballonnet au niveau du site d'une sténose à l'intérieur des voies respiratoires d'un patient adjacentes aux cordes vocales. Le procédé consiste à fournir un cathéter à lumière unique comportant une extrémité proximale comportant une première forme et une extrémité distale comportant une seconde forme, la première forme étant différente de la seconde forme, à former un ballonnet à haute pression comportant une partie centrale positionnée entre les extrémités proximale et distale qui maintient un profil sensiblement linéaire lorsque le ballonnet est gonflé, et à accoupler le ballonnet à haute pression à l'extrémité distale du cathéter. La première forme de l'extrémité proximale comporte une première longueur longitudinale qui est inférieure à une seconde longueur longitudinale de la seconde forme de l'extrémité distale pour permettre au ballonnet à haute pression d'être positionné à l'intérieur d'une sténose à proximité des cordes vocales.
PCT/US2023/014640 2022-03-04 2023-03-06 Cathéter de dilatation à ballonnet WO2023168123A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263316552P 2022-03-04 2022-03-04
US63/316,552 2022-03-04

Publications (1)

Publication Number Publication Date
WO2023168123A1 true WO2023168123A1 (fr) 2023-09-07

Family

ID=87884207

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/014640 WO2023168123A1 (fr) 2022-03-04 2023-03-06 Cathéter de dilatation à ballonnet

Country Status (1)

Country Link
WO (1) WO2023168123A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167608A1 (en) * 2005-09-21 2008-07-10 Rutter Michael John Balloon dilator
CN203075436U (zh) * 2012-12-27 2013-07-24 耿兴聪 肝胆外科用球囊扩张导管
US20170367718A1 (en) * 2016-06-24 2017-12-28 Bryan Medical, Inc. Balloon dilation catheter

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167608A1 (en) * 2005-09-21 2008-07-10 Rutter Michael John Balloon dilator
CN203075436U (zh) * 2012-12-27 2013-07-24 耿兴聪 肝胆外科用球囊扩张导管
US20170367718A1 (en) * 2016-06-24 2017-12-28 Bryan Medical, Inc. Balloon dilation catheter

Similar Documents

Publication Publication Date Title
CA2623952C (fr) Dispositif de dilatation a ballonnet pour voies respiratoires
US20200008821A1 (en) Balloon dilation catheter
US7771446B2 (en) Balloon dilator
JP4643173B2 (ja) 医療装置用バルーン
US10300257B2 (en) Features to enhance grip of balloon within airway
US7036510B2 (en) Percutaneous tracheostomy balloon apparatus
US3734100A (en) Catheter tubes
JP5059875B2 (ja) 穿刺用バルーン付きガイドチューブ
US8899225B2 (en) Percutaneous dilational device having balloon retention mechanism
US20050183729A1 (en) Dilational device having a reinforced balloon catheter
JP2002506380A (ja) ステント配備カテーテルシステムおよびバルーンカテーテル
US20170086868A1 (en) Apparatus for puncturing balloon in airway dilation shaft
US20140277058A1 (en) Airway dilation shaft with staggered adjacent internal lumens
US20110029060A1 (en) Lamellar shaped layers in medical devices
EP1942979B1 (fr) Dispositif de dilatation a ballonnet pour voies respiratoires
US10179227B2 (en) Resilient tube over dilator balloon
WO2023168123A1 (fr) Cathéter de dilatation à ballonnet
US9089663B2 (en) Percutaneous access device
KR20240051883A (ko) 풍선 카테터 사용 방법
Achkar et al. Balloon Dilation Complication during Treatment of Subglottic Stenosis: Background Case into the FDA Class 1 Recall for the 18x40 mm Acclarent Inspira AIR Balloon Dilation System

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: 23764012

Country of ref document: EP

Kind code of ref document: A1