US20150174353A1 - Tracheostomy tube and technique for using the same - Google Patents

Tracheostomy tube and technique for using the same Download PDF

Info

Publication number
US20150174353A1
US20150174353A1 US14577645 US201414577645A US2015174353A1 US 20150174353 A1 US20150174353 A1 US 20150174353A1 US 14577645 US14577645 US 14577645 US 201414577645 A US201414577645 A US 201414577645A US 2015174353 A1 US2015174353 A1 US 2015174353A1
Authority
US
Grant status
Application
Patent type
Prior art keywords
flange member
cannula
tracheostomy tube
conduit
proximal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
US14577645
Inventor
Robert W. Flagler
Carl Kling
Michael H. Vardanega
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien LP
Original Assignee
Covidien LP
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

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/0497Tube stabilizer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057Pumps therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0418Special features for tracheal tubes not otherwise provided for with integrated means for changing the degree of curvature, e.g. for easy intubation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0427Special features for tracheal tubes not otherwise provided for with removable and re-insertable liner tubes, e.g. for cleaning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0465Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816Joints or connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875Connecting tubes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • B29C45/14598Coating tubular articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16Making multilayered or multicoloured articles
    • B29C45/1676Making multilayered or multicoloured articles using a soft material and a rigid material, e.g. making articles with a sealing part
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2207/00Methods of manufacture, assembly or production
    • A61M2207/10Device therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00Tubular articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor

Abstract

A molded tracheostomy tube may provide enhanced comfort for a patient. A unitary molded coating over areas of the tracheostomy tube that come into contact with the patient's skin may prevent irritation. Further, the overmolding manufacturing process may allow the tracheostomy tube assembly to incorporate features that allow for greater ease of movement for a patient, such as features that allow flexing at the connection point of the tracheostomy tube to other medical devices.

Description

    CROSS-REFERENCE TO RELATED APPLICATION
  • This application is a continuation of patent application Ser. No. 11/527,070, entitled “Tracheostomy Tube and Technique for Using the Same” filed Sep. 26, 2006, which is herein incorporated by reference in its entirety for all purposes.
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention
  • The present invention relates to medical devices, and more particularly, to airway devices, such as tracheostomy tubes.
  • 2. Description of the Related Art
  • This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present invention which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
  • In the course of treating a patient, a tube or other medical device may be used to control the flow of air, food, fluids, or other substances into the patient. For example, medical devices, such as tracheal tubes, may be used to control the flow of one or more substances into or out of a patient. In many instances, it is desirable to provide a seal between the outside of the tube or device and the interior of the passage in which the tube or device is inserted. In this way, substances can only flow through the passage via the tube or other medical device, allowing a medical practitioner to maintain control over the type and amount of substances flowing into and out of the patient.
  • More specifically, tracheal tubes may be used to control the flow of air or other gases through a patient's trachea. Such tracheal tubes may include endotracheal tubes or tracheostomy tubes. While patients may be intubated using endotracheal tubes during emergencies or shorter hospital stays, tracheostomy tubes are more typically used for prolonged ventilation, as the use of a tracheostomy tube is generally more comfortable for a patient.
  • A typical tracheostomy tube is generally inserted into the trachea via a surgical incision in the neck. After insertion of the tube into the trachea, a portion of tube remains outside the patient. This portion extends outwards from the neck and may connect the tracheostomy tube to a ventilator or other medical device. Generally, this exterior portion of the tube is held in place by a flange that rests on the patient's neck and is further secured by straps to the patient. The inserted portion of the tracheostomy tube is generally mechanically coupled to the flange, typically by a snap or screw mechanism on the underside of the flange, which rests on the patient's neck. As such, the mechanical connection point may display angled edges that may irritate a patient's skin. Certain devices attempt to address this problem by providing pillow or fabric protectors for the neck that may lift the flange slightly off the neck to avoid skin irritation. However, these devices may compromise the secure attachment of the tracheostomy tube to the patient by providing a less stable base for the tube at the patient's neck.
  • A stable attachment of the tracheostomy tube to the patient is advantageous for preventing motion of the tube within the trachea. Because the exterior portion of the tracheostomy tube is connected to the inserted portion, when the exterior portion of the tube is shifted or moved, these movements may be translated to the interior potion of the tube. These movements may cause some discomfort for the patient if the tracheostomy tube shifts position within the trachea.
  • SUMMARY
  • Certain aspects commensurate in scope with the originally claimed invention are set forth below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the invention might take and that these aspects are not intended to limit the scope of the invention. Indeed, the invention may encompass a variety of aspects that may not be set forth below.
  • There is provided a tracheostomy tube that includes a cannula including a distal end and a proximal end, the distal end being adapted to be inserted into a patient's trachea; a flange member molded over the proximal end of the cannula; and a conduit disposed on the flange member in communication with the cannula, wherein the conduit is adapted to operatively connect to a medical device.
  • There is also provided a method of manufacturing a tracheostomy tube that includes providing a cannula comprising a distal end and a proximal end, the distal end being adapted to be inserted into a patient's trachea; molding a flange member over the proximal end of the cannula such that the proximal end of the cannula is coupled to the flange member; and disposing a conduit disposed on the flange member in communication with the cannula, wherein the conduit is adapted to operatively connect to a medical device.
  • There is also provided a method of sealing a patient's trachea that includes inserting a tracheostomy tube into a patient's trachea, wherein the tracheostomy tube comprises: a cannula comprising a distal end and a proximal end, the distal end being adapted to be inserted into a patient's trachea; a flange member molded over the proximal end of the cannula; and a conduit disposed on the flange member in communication with the cannula, wherein the conduit is adapted to operatively connect to a medical device.
  • There is also provided a tracheostomy tube mold form that includes: a mold cavity defining a flange member; a mold cavity defining a conduit adapted to be disposed on the flange member in communication with the cannula; and an opening in the mold form adapted to receive a cannula comprising a distal end and a proximal end, wherein the proximal end of the cannula is adapted to be inserted into at least a portion of the mold cavity defining the flange member.
  • There is also provided a unitary molded tracheostomy tube assembly that includes: a cannula adapted to be inserted into a patient's trachea comprising a distal end and a proximal end; a flange member disposed on the proximal end of the cannula; and a conduit disposed on the flange member in communication with the cannula, wherein the conduit is adapted to operatively connect to a medical device, and wherein the cannula, the flange member, and the conduit comprise a unitary molded structure.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Advantages of the invention may become apparent upon reading the following detailed description and upon reference to the drawings in which:
  • FIG. 1A illustrates a side perspective view of an overmolded tracheostomy tube with bellows and a notched flange in accordance with aspects of the present technique;
  • FIG. 1B illustrates a side perspective view of a disposable inner cannula lining and an overmolded tracheostomy tube with bellows and a notched flange in accordance with aspects of the present technique;
  • FIG. 2 illustrates a cross-sectional view of the tracheostomy tube of FIG. 1;
  • FIG. 3 illustrates an alternative configuration of a flange according to the present techniques;
  • FIG. 4 illustrates another alternative configuration of a flange according to the present techniques;
  • FIG. 5 illustrates yet another alternative configuration of a flange according to the present techniques; and
  • FIG. 6 illustrates an exemplary flange mold according to the present techniques.
  • DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
  • One or more specific embodiments of the present invention will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
  • Provided herein are tracheostomy tubes in which a flange portion is permanently attached to a cannula portion. Such tubes may allow for increased patient comfort. Typical tracheostomy tubes contain a curved cannula portion that is mechanically connected to an outer flange that is designed to rest on a patient's neck. This mechanical connection may include exposed notches or edges that may cause discomfort against a patient's skin. The tracheostomy tubes according to the present techniques may be molded or cast to provide a comfortable coating over the flange/cannula connection point that reduces the chance of such discomfort. Further, the coating results in a more robust tracheostomy tube assembly in which the flange portion is substantially permanently connected to the cannula portion without sacrificing patient comfort for increased durability. In specific embodiments, the tracheostomy tubes may also contain features that reduce the outside forces that may be transferred to inserted portion of the tube, which may cause discomfort if the tube shifts position and contacts the trachea. For example, the exterior flange and other patient exterior assemblies may include regions that allow for flexing or bending of the tracheostomy tube to reduce or eliminate the translation of movement to the interior portion of the tube.
  • FIGS. 1A and 1B show a side perspective view of an exemplary overmolded tracheostomy tube assembly 10 according to the present techniques. In the depicted embodiment, a portion of a cannula 12 is permanently embedded in a portion of a flange 20 member through an overmolding technique, described in detail below. Generally, a region of a preformed cannula 12 may be inserted into a mold suitably sized and shaped to form the flange member 20. A flange material may be injected into the mold so that as the flange material cools and hardens around the cannula 12, it permanently attaches itself to any portion of the cannula 12 that is contained in the mold. Alternatively, as provided herein, a tracheostomy tube assembly 10 may be formed from a single mold. In any case, a flange member 20 may be permanently attached to a cannula 12, without employing a mechanical coupling, such as a snap or screw.
  • The tracheostomy tube assembly 10 may include an arcuate cannula 12 having a distal end 14, which is generally sized and configured to be inserted through a patient tracheostomy. When the tracheostomy tube assembly 10 is in use, the distal end 14 as well as the major portion of the length of the cannula 12 will reside within the trachea, with the proximal end 16 being generally flush with the anterior surface of the patient's neck. The cannula 12 may also feature a small lumen (not shown) within the wall, accessed by notches 18 a and 18 b. This lumen is an airway that may be used to fill a balloon type sealing cuff 13 at the patient insertion end. The cuff 13 may be a urethane balloon bonded to the exterior of the cannula 12 such that the notch 18 b is encompassed. A user may inject air into the lumen through its access point at notch 18 a, which transfers air to the cuff. The cuff 13 may inflate within the patient airway to provide an additional seal.
  • The tracheostomy tube assembly 10 also features a flange 20 connected to the proximal end 16 of the cannula 12. The flange 20 is designed to rest on the neck of a patient and may feature openings 22 a and 22 b designed to accommodate attachment straps that may further secure the tracheostomy tube assembly 10 to the neck. The flange 20 may feature a conduit 24 that is substantially in-line with the proximal end 16 of the cannula 12. Generally, the conduit 24 may be adapted to connect the tracheostomy tube 10 to any suitable medical device. For example, the conduit 24 may serve as an insertion point for a disposable cannula lining 17 (shown in FIG. 1B) or may be suitably sized and shaped to connect the tracheostomy tube 10 via medical tubing or other devices to a mechanical ventilator.
  • In certain embodiments, the flange 20 may include features that allow the conduit 24 to move or flex to accommodate outside forces. Because the conduit 24 may be manipulated by healthcare providers to attach or detach a medical device, it may be advantageous for the conduit 24 to have some freedom of movement. For example, if a healthcare worker exerts force on the conduit 24 to connect a medical device, the conduit 24 may transmit some of that force into a bending or flexing motion so that the cannula 12, which is mostly inside the patient's trachea, does not experience the full force exerted on the conduit 24. As such, the cannula's 12 movements may be reduced, which may result in less irritation of the tracheal walls. Additionally, a flexible medical device connection point, i.e. the conduit 24, may increase possible patient room layout options. Such a feature may be advantageous in emergency room or operating room settings, where larger medical devices may be difficult and time-consuming to move. As depicted in FIG. 1, an annular notch or recess 26 that substantially surrounds the conduit 24 may allow the conduit 24 to have flexibility in several directions. Further, the conduit 24 may also feature a grooved region 28 that may allow additional degrees of freedom to the conduit 24. In certain embodiments, the grooved region 28 may include support ribs 30 to assist in supporting the conduit 24 in a substantially orthogonal position relative to the flange 20 absent any deforming forces applied to the conduit 24.
  • FIG. 2 is a cross-section view of the tracheostomy tube 10 of FIG. 1. As depicted, a flared portion 32 of the proximal end 16 of the cannula 12 is embedded in the flange member 20. The flange member 20 may also include guides 34 that may provide additional support to the proximal end 16 of the cannula 12. The conduit 24 defines a passageway 36 into which respiratory gases may flow. Passageway 36 may be connected with a passageway 38, defined by the cannula 12, to allow flow of respiratory gases into the trachea. Although the conduit 24 may bend or flex, the passageway 36 will remain substantially in-line with the passageway 38.
  • The grooved region 28 may include grooves with a substantially V-shaped cross-section with sloping sides that meet in a point, as shown. In other embodiments, the grooves in the grooved region 28 may have different configurations. For example, the grooves may include non-sloping sides that are connected by a substantially flat bottom region. In any case, the grooved region 28 allows the conduit 24 to bend at the area that includes the grooves. Further, in certain embodiments, the grooved region 28 may include semi-annular grooves that may allow flexibility only in certain directions where the grooves are located. Similarly, the notch 26 may also include any suitably shaped annular or semi-annular notch or groove that allows the flange to bend in the area surrounding the conduit.
  • The flexibility of the conduit 24 may be altered according to the needs of the patient or healthcare workers by altering the configuration of the flange member 20. For example, the flange member 20 illustrated in FIG. 3 includes a grooved region 28 with support ribs 30 without a notch 26 surrounding the conduit 24. Such a configuration may provide increased support to a heavier or larger conduit 24, which may be appropriate for a larger patient, while maintaining some degree of flexibility. The flange member 20 depicted in FIG. 4 includes a grooved region 40 substantially surrounding the conduit 24. Such an embodiment may confer increased degrees of freedom to the conduit 24, which may be advantageous for an active patient. In other embodiments (not shown), a grooved region (e.g. 28 or 40) may contain more or fewer grooves in order to alter the flexibility characteristics of the conduit 24. In other embodiments, a flange member 20 may contain no flexibility features, such as grooves or notches, if a healthcare worker is not particularly concerned about outside forces being transmitted to the tracheal walls. The flange member 20 may also include a certain degree of flexibility through the choice of an appropriate mold material, such as a thermoplastic elastomer. Such an embodiment may be appropriate for a stable patient in an intensive care setting, where the patient is not being moved very often.
  • In addition, as depicted in FIG. 5, increased flexibility for the conduit 24 may be achieved by molding portions of the flange member 20 into thin or membranous regions of thermoplastic material, such as a membranous region 42 surrounding the conduit 24. Such flexible regions may allow a greater range of motion for the conduit 24. In certain embodiments, the membranous region may be 0.03-0.05 inches in thickness, while the outer rim 44 of the flange member may be 0.1″-0.2″ thick. In an alternative embodiment the conduit 24 may exhibit an outer wall thickness of 0.07″-0.11″ be internally ribbed and may include ribs or grooves (not shown) molded into the interior passageway. The support ribs 30, may be 0.03″-0.1″ inches in thickness depending on material flexural modulus and may, for example, vary in number from 3 to 6.
  • The proximal end 16 of the cannula 12 may include a region that is embedded in the flange member 20 through an overmolding process. As noted above, in certain embodiments of the present technique, the tracheostomy tube 10 is overmolded to form a unitary or integral assembly in which the cannula 12 is integrated into the flange member 20 during the manufacturing process. Such overmolded embodiments may result in an assembly in which the tracheostomy tube 10 is completely or partially coated with a thermoplastic material, discussed in more detail herein. For example, the flange member 20 and conduit 24 may be formed by an injection molding process. In one example of such a process, the proximal end 16 of the cannula 12 may be positioned within a die or mold 48, shown in FIG. 6 of the desired shape for the flange member 20 and conduit 24. In certain embodiments, the mold 48 may include cavities defining the guides 34 on either side of an opening in the mold 48 designed to accommodate the proximal end 16 of the cannula 12. The mold 48 may also include an opening 50 into which the mold material may be injected. The guides 34 may help properly position the proximal end 16 of the cannula 12 in the mold. Additionally, the tracheostomy tube 10 may also include a second or distal conduit extension (not shown) that may be inserted into the proximal end 16 of the cannula 12 and radio-frequency welded to the cannula 12.
  • In certain embodiments, the tracheostomy tube 10 may be constructed, in whole or in part, from polymeric materials, such as thermoplastics, capable of providing a suitable rigidity or semi-rigidity. Examples of such suitable materials include polyvinylchloride, polyurethane, polypropylene and silicone, though other polymeric materials may also be suitable. In one implementation, the overmolding or coating is a thermoplastic elastomer or other conformable coating or material. In such embodiments, the thermoplastic elastomer may include compositions such as styrenic block copolymers, thermoplastic vulcanizate alloys, silicone, thermoplastic polyurethane, and so forth. Further, many elastomer alloys may be suitable as well. As will be appreciated by those of ordinary skill in the art, the overmolding composition may vary, depending on the varying degrees of conformability, durability, wettability, elasticity, or other physical and/or chemical traits that are desired. For example, in certain embodiments, the thermoplastic elastomer is selected to have a hardness between 30 and 60 Shore A to provide a robust yet comfortable material to rest against a patient's skin. In one embodiment, a suitable material having a hardness between 30 and 60 Shore A is employed to mold the flange member 20 while another material having a hardness between between 50 and 70 Shore A is employed to form the cannula 12. In embodiments in which the flange member 20 and the cannula 12 are formed from different materials, these materials may be selected based upon the desirability of a chemical bond between the between the flange member 20 and the cannula 12.
  • A molten or otherwise unset overmold material may then be injected into the die or mold. For example, in one implementation, a molten thermoplastic elastomer at between about 340.degree. F. to about 430.degree. F. is injected into the mold. The overmold material may then be set, such as by cooling for a period based upon wall thickness where cooling may take place at 30 seconds per 0.100″ thickness of overmold material to form the tracheostomy tube 10. In certain embodiments, shear-dependent overmold materials may be advantageous for molding thin or more intricate parts.
  • In an alternative embodiment, the tracheostomy tube 10 may be formed from a two-shot injection molding process in which a mold is moved or rotated from one injection barrel to a second injection barrel to allow two materials, which may be the same or different, to be injected one after the other in the same mold. Such a process may allow a first molded part to cool before the second molded part is formed. In certain embodiments, the mold may not move or rotate, but movable components within the mold may allow for molding shots from different barrels. In one embodiment, a two-shot molding process may involve injecting a higher durometer material for the conduit and injecting a softer durometer material for the flange. Additionally, insert injection molding techniques may also be appropriate for forming the tracheostomy tube 10.
  • The cannula 12 may be a pre-formed assembly that may be molded into the appropriate curved configuration or may be extruded and curved into a “J” shape with heat-setting. The proximal end of the cannula 12 may be flared using radio frequency energy. In certain embodiments, it may be advantageous to form perforation or depressions (not shown) into the flared region 32 of the cannula 12. In such an embodiment, the overmolding material may flow into the perforations or depressions to create an improved bond with the flared region 32.
  • The tracheostomy tubes 10 of the present techniques may be incorporated into systems that facilitate positive pressure ventilation of a patient, such as a ventilator. Such systems may typically include connective tubing, a gas source, a monitor, and/or a controller. The controller may be a digital controller, a computer, an electromechanical programmable controller, or any other control system.
  • While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.

Claims (20)

    What is claimed is:
  1. 1. A tracheostomy tube comprising:
    a cannula comprising a distal end and a flared proximal end, the distal end being adapted to be inserted into a patient's trachea;
    a flange member molded over the flared proximal end of the cannula such that the flared proximal end is embedded in the flange and wherein the flange member is configured to support the tracheostomy tube via engagement with the patient's neck to maintain the flange member outside of the patient's trachea; and
    a conduit disposed on the flange member in communication with the cannula, wherein the conduit is adapted to operatively connect to a medical device.
  2. 2. The tracheostomy tube of claim 1, comprising an inflatable cuff disposed on cannula.
  3. 3. The tracheostomy tube of claim 1, wherein the medical device comprises a ventilator.
  4. 4. The tracheostomy tube of claim 1, comprising a disposable cannula lining adapted to be slidably insertable into the cannula.
  5. 5. The tracheostomy tube of claim 1, wherein the conduit comprises a grooved portion adapted to allow the conduit to flex relative to the flange member.
  6. 6. The tracheostomy tube of claim 1, wherein the conduit is adapted to be substantially orthogonal relative to the flange member absent any deforming forces.
  7. 7. The tracheostomy tube of claim 1, wherein the flange member comprises a flexible radial section substantially surrounding the conduit adapted to allow the conduit to flex relative to the flange member.
  8. 8. The tracheostomy tube of claim 1, wherein the flange member comprises at least one groove adapted to allow the conduit to flex relative to the flange member.
  9. 9. The tracheostomy tube of claim 1, wherein the flange member comprises a thermoplastic elastomer, a polyvinylchloride, or a polyurethane.
  10. 10. The tracheostomy tube of claim 9, wherein the thermoplastic elastomer comprises at least one of a styrenic block copolymer, thermoplastic vulcanizate alloy, thermoplastic polyurethane, silicone, ethyl vinyl acetate, elastomer alloy, or a combination thereof.
  11. 11. The tracheostomy tube of claim 1, wherein the conduit is integral with the flange member.
  12. 12. The tracheostomy tube of claim 1, wherein the flange member is permanently coupled to the proximal end of the cannula.
  13. 13. The tracheostomy tube of claim 1, wherein the flange member is chemically bonded to the proximal end of the cannula.
  14. 14. A tracheostomy tube, comprising:
    a cannula having a first passageway extending between a distal end and a proximal end of the cannula, the distal end being configured to be inserted into a trachea;
    a conduit having a second passageway being substantially in line with the first passageway at the proximal end of the cannula; and
    a flange member that couples the first passageway to the second passageway, wherein the proximal end of the cannula is embedded in the flange member and wherein at least a portion of the conduit is integral with the flange member.
  15. 15. The tracheostomy tube of claim 14, wherein the flange member is integrally coupled to the proximal end of the cannula via injection molding, insert injection molding, or two-shot molding.
  16. 16. The tracheostomy tube of claim 14, wherein the flange member is formed from a material having a lower durometer than a material forming the conduit.
  17. 17. A method of forming a tracheostomy tube, comprising:
    providing a cannula having a distal end and a proximal end, the distal end of the cannula being configured to be inserted into a trachea;
    molding a first material over the proximal end of the cannula to form a flange member, wherein the flange member is configured to support the tracheostomy tube via engagement with a patient's neck to maintain the flange member outside of the trachea; and
    forming a conduit having a first passageway being communicatively coupled to the proximal end of the cannula, the conduit being configured to attach to an external medical device, wherein the conduit is formed from a second material.
  18. 18. The method of claim 17, wherein the first material forms the flange member by being molded through one or more perforations.
  19. 19. The method of claim 17, wherein the first material is softer than the second material.
  20. 20. The method of claim 17, wherein the proximal end is flared.
US14577645 2006-09-26 2014-12-19 Tracheostomy tube and technique for using the same Pending US20150174353A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US11527070 US8936025B2 (en) 2006-09-26 2006-09-26 Tracheostomy tube and technique for using the same
US14577645 US20150174353A1 (en) 2006-09-26 2014-12-19 Tracheostomy tube and technique for using the same

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US14577645 US20150174353A1 (en) 2006-09-26 2014-12-19 Tracheostomy tube and technique for using the same

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US11527070 Continuation US8936025B2 (en) 2006-09-26 2006-09-26 Tracheostomy tube and technique for using the same

Publications (1)

Publication Number Publication Date
US20150174353A1 true true US20150174353A1 (en) 2015-06-25

Family

ID=38776203

Family Applications (2)

Application Number Title Priority Date Filing Date
US11527070 Active 2030-11-14 US8936025B2 (en) 2006-09-26 2006-09-26 Tracheostomy tube and technique for using the same
US14577645 Pending US20150174353A1 (en) 2006-09-26 2014-12-19 Tracheostomy tube and technique for using the same

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US11527070 Active 2030-11-14 US8936025B2 (en) 2006-09-26 2006-09-26 Tracheostomy tube and technique for using the same

Country Status (2)

Country Link
US (2) US8936025B2 (en)
WO (1) WO2008039329A1 (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7600515B2 (en) * 2005-09-28 2009-10-13 Nellcor Puritan Bennett Llc Tracheostomy tube combination radial snap and bayonet cannula connector
US7647929B2 (en) 2005-09-28 2010-01-19 Nellcor Puritan Bennett Llc Medical device tube having a flange with opposing support ears for improved alignment and retention of an inner cannula in an outer cannula
US8936025B2 (en) 2006-09-26 2015-01-20 Covidien Lp Tracheostomy tube and technique for using the same
US20090250841A1 (en) * 2008-04-08 2009-10-08 Smiths Group Plc Tracheal tubes and a method of making the same
US20090320853A1 (en) * 2008-06-27 2009-12-31 Mike Kenowski Tracheostomy Tube
CA2739648A1 (en) * 2008-10-14 2010-04-22 Lawrence Stock Training device for medical procedures
US20100300449A1 (en) * 2009-05-28 2010-12-02 Chan Sam C Position Indicator for Tracheostomy Tube
US20100300448A1 (en) * 2009-05-28 2010-12-02 Kenowski Michael A Tracheostomy Tube
US8590534B2 (en) * 2009-06-22 2013-11-26 Covidien Lp Cuff for use with medical tubing and method and apparatus for making the same
US8522788B2 (en) * 2010-03-26 2013-09-03 Covidien Lp Tracheostomy tube with filleted flange
US20110290254A1 (en) * 2010-05-27 2011-12-01 Nellcor Puritan Bennett Llc Tracheal tube with connector insert
US20120103341A1 (en) * 2010-10-29 2012-05-03 Nellcor Puritan Bennett Llc Tracheal tube with connector insert
US20120118294A1 (en) * 2010-11-11 2012-05-17 Nellcor Puritan Bennett Llc Tracheal tube with reinforced proximal extension
US8905030B2 (en) 2011-03-31 2014-12-09 Covidien Lp Tracheal tube with connector insert
NL2007326C (en) * 2011-09-01 2013-03-04 Stichting Katholieke Univ Automatic tracheostoma speech valve (atsv) fixation brace.
US8739796B2 (en) 2011-09-29 2014-06-03 Covidien Lp Tracheal tube flange member
DE102011120694A1 (en) * 2011-12-05 2013-06-06 Primed Halberstadt Medizintechnik Gmbh An outer cannula Tracheostoma- prosthesis for easy installation and easy removal of an inner cannula
USD753817S1 (en) 2012-07-31 2016-04-12 Covidien Lp Tracheostomy tube
USD753818S1 (en) 2012-07-31 2016-04-12 Covidien Lp Tracheostomy tube
US9010326B2 (en) 2012-08-02 2015-04-21 Covidien Lp Compressible connector for an inner cannula
WO2014090549A1 (en) * 2012-12-11 2014-06-19 Atos Medical Ab Tracheostoma device holder
US9265906B2 (en) 2013-02-25 2016-02-23 Covidien Lp Compressible cannula connector with release grip
EP2835245B1 (en) * 2013-08-05 2017-11-15 Vaillant GmbH Two component condensate hose

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3388705A (en) * 1965-04-08 1968-06-18 Foregger Company Inc Universal endotracheal tube coupling or adaptor
US3973569A (en) * 1975-08-06 1976-08-10 National Catheter Corporation Tracheostomy tube device with neck size adjustment means
US5391248A (en) * 1992-03-05 1995-02-21 Brain; Archibald I. J. Method of making an artificial airway device
US5515844A (en) * 1989-11-02 1996-05-14 Christopher; Kent L. Method and apparatus for weaning ventilator-dependent patients
US20070112361A1 (en) * 2005-11-07 2007-05-17 Schonholz Steven M Surgical repair systems and methods of using the same

Family Cites Families (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2786469A (en) 1953-12-18 1957-03-26 Cohen William Tracheal tube assembly and tracheal plug
US3169529A (en) 1963-05-27 1965-02-16 Norman Z Koenig Tracheostomy tube
US3225767A (en) 1964-03-13 1965-12-28 South Chester Corp Tracheal tube device
US4033353A (en) 1975-10-16 1977-07-05 International Paper Company Tracheostomy tube
US4033363A (en) * 1976-04-14 1977-07-05 Lawrence Peska Associates, Inc. Cuticle instrument
FI792308A (en) 1978-08-10 1980-02-11 Smiths Industries Ltd Andningstub
US4235229A (en) * 1979-06-06 1980-11-25 Sherwood Medical Industries Inc. Adjustable tracheostomy tube assembly
US4315505A (en) 1980-04-07 1982-02-16 Shiley, Inc. Tracheostomy tube with disposable inner cannula
US4332245A (en) 1980-08-19 1982-06-01 Boone Sr Frank J Emergency trachea airway
US4340046A (en) * 1980-12-08 1982-07-20 Cox Everard F Static tracheostomy tube
US4449523A (en) 1982-09-13 1984-05-22 Implant Technologies, Inc. Talking tracheostomy tube
US4573979A (en) 1984-08-23 1986-03-04 Innovative Surgical Products, Inc. Irrigation/aspiration tip
US4781703A (en) 1985-10-17 1988-11-01 Menlo Care, Inc. Catheter assembly
US4817598A (en) 1987-06-08 1989-04-04 Portex, Inc. Tracheostomy tube with ring pull removable inner cannula
US4955861A (en) 1988-04-21 1990-09-11 Therex Corp. Dual access infusion and monitoring system
US5054482A (en) 1990-09-26 1991-10-08 Bales Joseph H Rotatable tracheostomy tube assembly
DE4100837A1 (en) 1991-01-14 1992-07-16 Volker Bertram Adapter with tracheal tube
US5819734A (en) * 1991-09-23 1998-10-13 Mallinckrodt Medical, Inc. Neck flange for holding a tracheostomy tube in place and allowing limited movement therebetween and tracheostomy procedure using the same
US5645048A (en) 1992-05-06 1997-07-08 The Kendall Company Patient ventilating apparatus with modular components
US5390669A (en) 1993-08-09 1995-02-21 Mallinckrodt Medical, Inc. Device using connector tube to lock inner cannula inside outer cannula
US5458139A (en) 1993-08-30 1995-10-17 Susan O. Pearl Low profile tracheostomy tube assembly
US5460176A (en) 1994-01-31 1995-10-24 Mallinckrodt Medical, Inc. Positive locking cannula
GB9411215D0 (en) 1994-06-04 1994-07-27 Brain Archibald Ian Jeremy A fibreoptic intubating laryngeal mask airway
US5794986A (en) 1994-09-15 1998-08-18 Infrasonics, Inc. Semi-disposable ventilator breathing circuit tubing with releasable coupling
US5579762A (en) 1995-08-01 1996-12-03 Lee; Cindy Endotracheal device to facilitate joining an endotracheal tube to an adaptor connected to a suction or gas source
US5697365A (en) 1996-01-18 1997-12-16 Pell; Donald M. Endotracheal tube construction and method for intubating a patient
US5806515A (en) * 1997-03-28 1998-09-15 Passy-Muir, Inc. Supplemental oxygen adapter for tracheostomy speaking valves
GB2328878B (en) 1997-09-02 2001-07-25 Smiths Industries Plc Medico-surgical tubes
US6135110A (en) 1998-04-22 2000-10-24 Sims Portex Inc. Tracheostomy tube
US6248099B1 (en) 1998-05-14 2001-06-19 Medcare Medical Group, Inc. Disposable tracheostomy inner cannula connector
US6135111A (en) * 1998-08-31 2000-10-24 Vital Signs Inc. Tracheostomy tube with removable inner cannula
EP1005877A3 (en) 1998-12-03 2000-11-08 Smiths Industries Public Limited Company Cuffed tubes
US6772758B2 (en) 1999-09-30 2004-08-10 Atos Medical Breathing protector
US6634357B1 (en) 2000-02-22 2003-10-21 Life Support Technology, Inc. Resuscitation valve assembly
GB0016669D0 (en) 2000-07-06 2000-08-23 Univ London Conduit end fittings
DE60120335T2 (en) 2000-12-23 2006-10-05 Smiths Group Plc tracheal tube
DE10140292A1 (en) 2001-08-16 2003-03-06 Ruesch Willy Gmbh Connecting element attached to closure element has elliptical ends, with first and second detent elements and pressure elements
US7147252B2 (en) 2001-12-21 2006-12-12 Kimberly-Clark Worldwide, Inc. Medical connector
US6698424B2 (en) 2001-12-21 2004-03-02 Kimberly-Clark Worldwide, Inc. Medical connector for a respiratory assembly
US6802836B2 (en) 2002-02-19 2004-10-12 Scimed Life Systems, Inc. Low profile adaptor for use with a medical catheter
US6789542B1 (en) 2002-02-22 2004-09-14 Bischoff Medical Devices, Llc Decorative valved tracheostomy device
EP1617891A2 (en) 2003-04-25 2006-01-25 Smiths Group plc Tracheostomy device
US7681576B2 (en) * 2003-05-06 2010-03-23 Mallinckrodt Inc. Multiple cannula systems and methods
US20050144761A1 (en) 2003-12-31 2005-07-07 Hatcher Michelle L. Designer tracheostomy tube and other neck wearing device attachment
US6994088B2 (en) 2004-01-22 2006-02-07 Briggs Iii Stephen W Device and method for securing tracheostomy tube attachments
US8074650B2 (en) 2004-02-27 2011-12-13 Dale Medical Products, Inc. Tracheostomy tube holder
US20060060201A1 (en) 2004-09-23 2006-03-23 Beagle Amy L Tracheostomy tube with improved tie and method holding same
US20070012317A1 (en) 2005-07-08 2007-01-18 Flagler Robert W Medical device tube
US7987851B2 (en) 2005-12-27 2011-08-02 Hansa Medical Products, Inc. Valved fenestrated tracheotomy tube having outer and inner cannulae
US8936025B2 (en) 2006-09-26 2015-01-20 Covidien Lp Tracheostomy tube and technique for using the same
US20080142003A1 (en) 2006-12-13 2008-06-19 Arcadia Medical Corporation MRI Compatible Airway Management Device
US8416876B2 (en) 2007-06-14 2013-04-09 Electronics And Telecommunications Research Institute Transmitter/receiver for controlling multiuser multiple input multiple output system and method thereof
US20090025730A1 (en) 2007-07-24 2009-01-29 Pinel Lloyd J Post decannulation stoma cover

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3388705A (en) * 1965-04-08 1968-06-18 Foregger Company Inc Universal endotracheal tube coupling or adaptor
US3973569A (en) * 1975-08-06 1976-08-10 National Catheter Corporation Tracheostomy tube device with neck size adjustment means
US5515844A (en) * 1989-11-02 1996-05-14 Christopher; Kent L. Method and apparatus for weaning ventilator-dependent patients
US5391248A (en) * 1992-03-05 1995-02-21 Brain; Archibald I. J. Method of making an artificial airway device
US20070112361A1 (en) * 2005-11-07 2007-05-17 Schonholz Steven M Surgical repair systems and methods of using the same

Also Published As

Publication number Publication date Type
US8936025B2 (en) 2015-01-20 grant
WO2008039329A1 (en) 2008-04-03 application
US20080072911A1 (en) 2008-03-27 application

Similar Documents

Publication Publication Date Title
US7370652B2 (en) Patient interface device
US7210481B1 (en) Nose mask
US6629530B2 (en) Single-element sealing valve for a respiratory support system
US3814103A (en) Binasal pharyngeal airway
US5199427A (en) Multi-layered transtracheal caatheter
US6412488B1 (en) Low contact nasal mask and system using same
US6530373B1 (en) Respirator mask
US20060096600A1 (en) Oral appliance
US7152599B2 (en) Nasal mask for delivering gas
US20100313891A1 (en) Respiratory mask
US5819734A (en) Neck flange for holding a tracheostomy tube in place and allowing limited movement therebetween and tracheostomy procedure using the same
US20080149104A1 (en) Ventilator mask with a filler and method of production
US7287528B2 (en) Cushion inside a cushion patient interface
US20090044808A1 (en) Patient interface
EP1057494B1 (en) Air mask with seal
US20090120442A1 (en) Non-intrusive mask interface with nasal support
US20090032024A1 (en) Respiratory Mask and Method for Manufacturing a Respiratory Mask
US20070267017A1 (en) Breathing Assistance Apparatus
US20050081861A1 (en) Airway device
US20070125384A1 (en) Infant nasal interface mask
US20060207599A1 (en) Interface with rolling diaphragm
US20060185675A1 (en) Customizable facial seal for masks delivering breathing gases in positive pressure ventilation systems
US20070277828A1 (en) Flexible connector
US20100236549A1 (en) Elbow assembly
US20020010417A1 (en) Transpharyngeal tube

Legal Events

Date Code Title Description
AS Assignment

Owner name: COVIDIEN LP, MASSACHUSETTS

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:FLAGLER, ROBERT W.;KLING, CARL;VARDANEGA, MICHAEL H.;REEL/FRAME:034580/0786

Effective date: 20060925