WO1996026756A1 - Endotracheal tube holder - Google Patents

Endotracheal tube holder Download PDF

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Publication number
WO1996026756A1
WO1996026756A1 PCT/US1995/002564 US9502564W WO9626756A1 WO 1996026756 A1 WO1996026756 A1 WO 1996026756A1 US 9502564 W US9502564 W US 9502564W WO 9626756 A1 WO9626756 A1 WO 9626756A1
Authority
WO
WIPO (PCT)
Prior art keywords
endotracheal tube
tube holder
wing
hinge
lumen
Prior art date
Application number
PCT/US1995/002564
Other languages
French (fr)
Inventor
M. Simon Freed
Original Assignee
Freed M Simon
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 Freed M Simon filed Critical Freed M Simon
Publication of WO1996026756A1 publication Critical patent/WO1996026756A1/en
Priority to US08/919,622 priority Critical patent/US6029668A/en

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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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00154Holding or positioning arrangements using guiding arrangements for insertion
    • 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
    • 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
    • A61M16/049Mouthpieces
    • A61M16/0493Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M2025/024Holding devices, e.g. on the body having a clip or clamp system
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0625Mouth
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/26Cannula supporters
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/912Connections and closures for tubes delivering fluids to or from the body

Definitions

  • the invention relates to holders for endotracheal tubes.
  • An endotracheal tube is generally inserted in the trachea1 lumen of a patient, through the patient's mouth, to deliver air to the patient's lungs when the mouth, throat or trachea of the patient is obstructed. It is important that the endotracheal tube be securely retained in the patient's mouth to prevent accidental removal of the tube from the tracheal lumen, which could result in asphyxiation. It is also important to minimize damage to the mucous membrane of the larynx and trachea caused by rubbing of the tube against the membrane. The tube must be retained in a manner which will secure it against shifts in the patient's position, movement of attached ventilating equipment and slippage.
  • endotracheal tubes were typically held in place by tape. Retaining the tube in this manner was difficult to accomplish and unreliable, as the tape would not always adhere to the patient's skin and required a relatively high degree of skill to apply quickly and securely. This method also made it impractical to adjust the orientation of the tube in the tracheal lumen after the initial insertion.
  • endotracheal tube holders are thought to allow the tube to be more quickly and easily inserted and positioned, and may include means for preventing the patient from biting the tube.
  • these holders do not allow the patient's mouth to be easily accessed by medical staff, e.g., for the administration of medicaments.
  • many such devices require two-handed operation and are not readily adjustable. summary of tft*.
  • the present invention features an improved endotracheal tube holder which allows a patient's mouth to be readily accessed when the endotracheal tube and holder are in place, and which is easily operated and adjusted with one hand.
  • the tube holder also provides good resistance to biting, and it is comfortable to the patient.
  • the invention features an endotracheal tube holder for retaining an endotracheal tube in a patient's mouth, including a first member and a second member, positioned in opposed, spaced relation relative to the first member.
  • the first member includes a first pair of wing members and a first portion disposed between the first pair of wing members
  • the second member includes a second pair of wing members and a second portion disposed between the second pair of wing members, the first and second pairs of wing members being dimensioned and arranged so that when the endotracheal tube holder is in a closed position a region of each wing of the first member is adjacent to a region of a corresponding opposed wing of the second member, and the first and second portions being arranged and dimensioned so that when the first and second members are so positioned the first and second portions define a lumen dimensioned to receive the endotracheal tube.
  • the holder further includes a hinge about which the first member can pivot with respect to the second member; a safety clamp, disposed in a region of the opposed wings and including a portion which provides interference engagement between the wings to limit the extent to which the first member and second member can pivot about the hinge to a maximum angle that is sufficiently large to allow the position of the endotracheal tube in the housing to be adjusted axially, and sufficiently small so that the tube cannot be radially displaced from the endotracheal tube holder when the safety clamp is engaged; and a securing clamp disposed in a region of the opposed wings, the securing clamp being movable between a first position, in which the first member and the second member are allowed to pivot to the extent allowed by the safety clamp, to allow for axial adjustment of the endotracheal tube within the lumen, and a second position, in which the first portion and the second portion are sufficiently close to each other to engage the tube in a manner to limit axial movement of the tube relative to the endotracheal tube holder.
  • the upper portion is joined to the lower portion by a flexible hinge extending between a first wing of the upper portion and an opposed first wing of the lower portion.
  • the wings are arranged and dimensioned so that when the hinge is in a closed position, a region of each wing of the upper portion is adjacent to a region of a corresponding opposed wing of the lower portion.
  • the semi-cylindrical members are arranged and dimensioned so that, when the hinge is in a closed position, the semi-cylindrical members together define a sleeve, the sleeve defining a lumen dimensioned to receive the endotracheal tube.
  • a safety clamp disposed in a region of the opposed wings adjacent the hinge is adapted to limit the extent to which the upper portion and the lower portion can pivot apart about the hinge to a predetermined maximum angle, whereby the position of the endotracheal tube in the housing can be adjusted axially and radial displacement the tube from the endotracheal tube holder is restricted.
  • a securing clamp disposed in a region of opposed wings relatively more spaced from the hinge is adapted to be moved between a first position, in which the upper portion and the lower portion are allowed to pivot to the extent allowed by the safety clamp, to allow for axial adjustment of the endotracheal tube within the lumen, and a second position, in which the sleeve engages the tube in a manner to limit axial movement thereof of the tube relative to the endotracheal tube holder.
  • the wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of the semi-cylindrical member and a substantially horizontal line taken radially across the semi-cylindrical member.
  • the sleeve includes a plurality of raised structures on its inner surface.
  • the safety clamp comprises a resilient member extending upwardly from the lower portion, through an aperture in the upper portion, the resilient member comprising a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion.
  • the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define an angle of less than about 30°, and more preferably the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define a maximum angle of from about 5° to 10°.
  • the securing clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion.
  • resilient member is dimensioned so that when the latch member engages the upper portion, the lumen defined by the upper and lower semi-cylindrical members has a predetermined diameter which is substantially equal to that of an outer surface of the endotracheal tube.
  • the invention features a method of inserting and retaining an endotracheal tube in the tracheal lumen of a patient.
  • the method comprises the steps of: inserting the endotracheal tube through the patient's mouth into the tracheal lumen; providing an endotracheal tube holder comprising upper and lower portions each comprising a semi-cylindrical member and a pair of wings extending radially on opposite sides of the semi-cylindrical member, the upper portion being joined to the lower portion by a flexible hinge extending between a first wing of the upper portion and an opposed first wing of the lower portion, the wings being arranged and dimensioned so that when the hinge is in a closed position, a region of each upper wing is adjacent to a region of a corresponding lower wing, the semi- cylindrical members being arranged and dimensioned so that, when the hinge is in a closed position, the semi- cylindrical members together define a sleeve, the sleeve defining a lumen dimension
  • Preferred embodiments of this aspect of the invention may include one or more of the following additional steps.
  • the step of closing the securing clamp is performed with one hand.
  • the wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of the semi-cylindrical member and a substantially horizontal line taken radially across the semi-cylindrical member.
  • the sleeve includes a plurality of raised structures on its inner surface.
  • the safety clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion.
  • the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define an angle of less than about 30°, preferably, the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define a maximum angle of from about 5° to 10°.
  • the securing clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion.
  • the resilient member is dimensioned so that when the latch member engages the upper portion the lumen defined by the upper and lower semi-cylindrical members has a predetermined diameter which is substantially equal to that of an outer surface of the endotracheal tube.
  • a first portion of each wing, adjacent the semi-cylindrical portion extends downward from the horizontal plane, and a second more remote portion of each wing extends outwardly in a plane substantially parallel to the horizontal plane.
  • FIG. 1 is perspective view of an endotracheal tube holder according to one embodiment of the invention.
  • Fig. 2 is a front view of the tube holder of Fig. 1.
  • Fig. 3 is an enlarged cross-sectional view of Detail 3 in Fig. 2.
  • Fig. 3a is a highly enlarged perspective view of the clamp shown in Fig. 3.
  • Fig. 4 is an enlarged cross-sectional view of Detail 4 in Fig. 2.
  • Figs. 5 - 5f are views, taken from different angles, of an endotracheal tube holder according to an alternate embodiment of the invention.
  • Figs. 6 - 6f are views, taken from different angles, of an endotracheal tube holder according to a further alternate embodiment of the invention.
  • Figs. 7 and 8 are partial enlarged cross-sectional side views of latch mechanisms according to alternate embodiments of the invention.
  • a preferred endotracheal tube holder 10 of the invention includes an integral housing 12 having a "clamshell" type structure, i.e., housing 12 comprises two halves, upper half 20 and lower half 21, which are joined by a flexible hinge 22. Each half comprises a semi-cylindrical portion 122a, 122b, and a pair of wings 124a, 126a, and 124b, 126b.
  • Sleeve 14 defines a lumen 15, dimensioned to receive an endotracheal tube (not shown) .
  • Sleeve 14 is preferably formed of a rigid, resilient material, e.g., polypropylene, which has sufficient rigidity to act as a bite guard for the endotracheal tube, preventing the patient from damaging or closing the tube by biting down on it, and sufficient resiliency to provide cushioning for patient comfort.
  • sleeve 14 has a plurality of longitudinal ribs 18 on its inner surface 11, to provide a more positive grip of the sleeve about the endotracheal tube extending therethrough.
  • a flange 123 having portions 123a, 123b, extends radially from the outer surface of the sleeve in a manner to aid in longitudinal positioning of the sleeve by engaging gently against 'a patient's upper and lower front teeth, as described in more detail below.
  • Each pair of adjacent wings i.e., pairs 124a, 124b and pairs 126a, 126b, forms a wing structure 16a, 16b when hinge 22 is in a closed position, as shown in Figs. 1 and 2.
  • the two wing structures curve upwardly, out of a plane defined by the axis of the tube and sleeve 14 and a horizontal line A across the patient's mouth, to allow easy access to the patient's mouth on either side of the housing in a manner to facilitate more thorough and efficient mouth care.
  • Two neck/head strap holders 19 are mounted on the housing, one on each wing, to receive a strap (not shown) which is fastened behind the patient's neck or head.
  • the diameter of lumen 15 defined by sleeve 14 is determined by the spacing between the semi-cylindrical members. To adjust this spacing, and to hold the upper and lower halves relatively close together, so that the holder can be manipulated with one hand, the housing is provided with a pair of clamps.
  • the housing includes a securing clamp 30 on wing 16b and a safety clamp 28 on wing 16a.
  • Safety clamp 28 which is closest to hinge 22, is provided to act as a stop, limiting the amount of separation between the two halves, preferably to an extent so that, when the hinge is open to the fullest extent allowed by the safety clamp, a lumen is still defined by the semi-cylindrical portions at least to an extent to prevent radial displacement of the tube from the lumen.
  • the safety clamp allows the diameter of the lumen to be increased sufficiently to allow axial adjustment of the endotracheal tube, also without allowing the two halves to become separated, e.g. , so it that is difficult to close them with one hand or so that the tube becomes lodged in the opening. Referring to Fig.
  • safety clamp 28 shown in detail, comprises a resilient member 40 which extends upwardly from wing 124b of the lower half 21 of the housing, through aperture 45 in opposed wing 124a.
  • Resilient member 40 includes a latch member 42 and a release member 44.
  • Wing 124a defines a shoulder 43, positioned for engagement by latch member 42.
  • Resilient member 40 is dimensioned so that, when latch member 42 and shoulder 43 are engaged, as shown in Fig. 4, the two halves of the housing can be separated (pivoted about hinge 22) to define a maximum angle B therebetween.
  • angle B is less than about 30°, more preferably angle B is about 5° to 10°. If it is desired to open the two halves beyond the extent allowed by the safety latch, latch member 42 may be released from shoulder 43 by depressing release member 44.
  • Securing clamp 30 when engaged, clamps the housing around the tube, thereby securely holding the tube against both axial and radial displacement, and, when disengaged, allows the housing to open to the extent allowed by safety clamp 28.
  • securing clamp 30 shown in detail, comprises resilient member 32, which extends upwardly from wing 126b of lower half 21, through aperture 33 in wing 126a.
  • Resilient member 32 includes latch member 34 and release member 36.
  • Securing clamp 30 functions in the same manner as does safety clamp 28, i.e., the latch member engages the upper wing until it is released therefrom by depressing the release member. (Apertures in the wings 124b, 126b (Figs. 3a and 4, respectively) facilitate the manufacturing process.)
  • an endotracheal tube is first inserted through the patient's mouth into the tracheal lumen.
  • the sleeve of the holder is slid over the endotracheal tube.
  • the safety clamp is then closed, and, with the securing clamp still open, the position of the holder is adjusted axially along the tube until the holder is in a desired position, preferably with the flange portions engaged gently against the patient's teeth.
  • a neck/head strap, attached to the wings on either side of the housing, is then typically fastened about the neck or head of the patient.
  • the securing clamp is then closed, typically with one hand, securing the tube firmly in position within the holder. If further adjustment of the holder later becomes necessary, this can easily be accomplished by unfastening the securing clamp, sliding the tube axially within the lumen of the holder, and refastening the securing clamp.
  • the ribs 18 on sleeve 14 may, in the alternative, be axial or spiral.
  • a second securing clamp may be provided, preferably at right angle to the first securing clamp, thus to require use of two hands for release of the device.
  • Figs. 5-5f, 6-6f, 7 and 8 are illustrated in Figs. 5-5f, 6-6f, 7 and 8.
  • the upper and lower members need not be unitary, as shown in Fig. 4, but can instead be separate members 202, 204 joined at a hinge 206.
  • the bite block 208 can extend to any desired extent from the wings, and may be square in cross-section, as shown, or have any desired cross- sectional shape. It may also be desired to cover the bite block with a flexible sheath or a coating or layer of soft material, to improve patient comfort.
  • member 204 can have a cantilevered structure so that it can bend in region 210, as shown in Fig. 5d, to adapt to different size tubes.
  • the first and second portions 212, 214 which together define the lumen, can have an semi-elliptical or V-shaped cross- section, rather than a semi-cylindrical shape, to allow tubes having a range of outer diameters to have at least two points of contact with the lumen.
  • the safety clamp and securing clamp be on opposite sides of the lumen (this prevents inadvertent opening of the device by a patient)
  • the safety clamp and securing clamp can be disposed on the same side of the lumen. This can be accomplished in many ways, as will be appreciated by the artisan. Two examples are shown in Figs. 7 and 8. In Fig. 7, one of the upper and lower members includes step-like detents 216 and the other member includes a resilient member 218 having a protrusion 220 shaped to engage detents 216.
  • Deflection of the resilient member 218, by depressing latch member 222, allows the protrusion to be moved to and engaged with a detent (e.g., 216a) in a position in which the lumen is small enough to securely hold the tube (thus acting as the securing clamp) or with another detent (e.g. , 216b) in a position in which the lumen is large enough to allow the tube to move axially but small enough to retain the tube radially (thus acting as the safety clamp) .
  • a detent e.g., 216a
  • another detent e.g. , 216b
  • This embodiment is also advantageous in that different tube outer diameters can be accommodated by providing many detents, as shown, and selecting an appropriate detent for the given tube diameter to provide each of the securing and safety clamp functions.
  • one of the upper and lower members includes a plurality of teeth 224, positioned in two spaced sets, and the other member includes a plurality of notches 226 on the other member dimensioned and arranged to engage one set of teeth.

Abstract

An endotracheal tube holder (10) has an upper portion (20) and a lower portion (21), each with a semi-cylindrical member (122a, 122b) with wings (124a, 126a; 124b, 126b) extending radially on opposite sides. The upper and lower portions are joined by a flexible hinge (22) between an upper portion first wing (124b) and an opposed lower portion first wing (124a). When the hinge is closed, the members form a sleeve (14) defining a lumen (15) sized to receive the endotracheal tube. A safety clamp (28) limits the extent of pivoting of the portions about the hinge to a predetermined maximum angle allowing axial adjustment of the endotracheal tube and restricting radial displacement. A securing clamp (30) has a first position allowing axial adjustment of the endotracheal tube and limiting radial movement, and a second position with the sleeve engaging the tube to also limit axial movement.

Description

ENDOTRACHEAL TUBE HOLDER Background of the Invention The invention relates to holders for endotracheal tubes.
An endotracheal tube is generally inserted in the trachea1 lumen of a patient, through the patient's mouth, to deliver air to the patient's lungs when the mouth, throat or trachea of the patient is obstructed. It is important that the endotracheal tube be securely retained in the patient's mouth to prevent accidental removal of the tube from the tracheal lumen, which could result in asphyxiation. It is also important to minimize damage to the mucous membrane of the larynx and trachea caused by rubbing of the tube against the membrane. The tube must be retained in a manner which will secure it against shifts in the patient's position, movement of attached ventilating equipment and slippage.
Until relatively recently, endotracheal tubes were typically held in place by tape. Retaining the tube in this manner was difficult to accomplish and unreliable, as the tape would not always adhere to the patient's skin and required a relatively high degree of skill to apply quickly and securely. This method also made it impractical to adjust the orientation of the tube in the tracheal lumen after the initial insertion.
To remedy this situation, various types of endotracheal tube holders have been developed. These holders are thought to allow the tube to be more quickly and easily inserted and positioned, and may include means for preventing the patient from biting the tube. However, typically these holders do not allow the patient's mouth to be easily accessed by medical staff, e.g., for the administration of medicaments. Also, many such devices require two-handed operation and are not readily adjustable. summary of tft*. invention The present invention features an improved endotracheal tube holder which allows a patient's mouth to be readily accessed when the endotracheal tube and holder are in place, and which is easily operated and adjusted with one hand. The tube holder also provides good resistance to biting, and it is comfortable to the patient.
Broadly, the invention features an endotracheal tube holder for retaining an endotracheal tube in a patient's mouth, including a first member and a second member, positioned in opposed, spaced relation relative to the first member. The first member includes a first pair of wing members and a first portion disposed between the first pair of wing members, and the second member includes a second pair of wing members and a second portion disposed between the second pair of wing members, the first and second pairs of wing members being dimensioned and arranged so that when the endotracheal tube holder is in a closed position a region of each wing of the first member is adjacent to a region of a corresponding opposed wing of the second member, and the first and second portions being arranged and dimensioned so that when the first and second members are so positioned the first and second portions define a lumen dimensioned to receive the endotracheal tube. The holder further includes a hinge about which the first member can pivot with respect to the second member; a safety clamp, disposed in a region of the opposed wings and including a portion which provides interference engagement between the wings to limit the extent to which the first member and second member can pivot about the hinge to a maximum angle that is sufficiently large to allow the position of the endotracheal tube in the housing to be adjusted axially, and sufficiently small so that the tube cannot be radially displaced from the endotracheal tube holder when the safety clamp is engaged; and a securing clamp disposed in a region of the opposed wings, the securing clamp being movable between a first position, in which the first member and the second member are allowed to pivot to the extent allowed by the safety clamp, to allow for axial adjustment of the endotracheal tube within the lumen, and a second position, in which the first portion and the second portion are sufficiently close to each other to engage the tube in a manner to limit axial movement of the tube relative to the endotracheal tube holder. According to one preferred aspect of the invention, an endotracheal tube holder for retaining an endotracheal tube in a patient's mouth comprises upper and lower portions each comprising a semi-cylindrical member and a pair of wings extending radially on opposite sides of the semi-cylindrical member. The upper portion is joined to the lower portion by a flexible hinge extending between a first wing of the upper portion and an opposed first wing of the lower portion. The wings are arranged and dimensioned so that when the hinge is in a closed position, a region of each wing of the upper portion is adjacent to a region of a corresponding opposed wing of the lower portion. The semi-cylindrical members are arranged and dimensioned so that, when the hinge is in a closed position, the semi-cylindrical members together define a sleeve, the sleeve defining a lumen dimensioned to receive the endotracheal tube. A safety clamp disposed in a region of the opposed wings adjacent the hinge is adapted to limit the extent to which the upper portion and the lower portion can pivot apart about the hinge to a predetermined maximum angle, whereby the position of the endotracheal tube in the housing can be adjusted axially and radial displacement the tube from the endotracheal tube holder is restricted. A securing clamp disposed in a region of opposed wings relatively more spaced from the hinge is adapted to be moved between a first position, in which the upper portion and the lower portion are allowed to pivot to the extent allowed by the safety clamp, to allow for axial adjustment of the endotracheal tube within the lumen, and a second position, in which the sleeve engages the tube in a manner to limit axial movement thereof of the tube relative to the endotracheal tube holder.
Preferred embodiments of this aspect of the invention may include one or more of the following additional features. The wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of the semi-cylindrical member and a substantially horizontal line taken radially across the semi-cylindrical member. The sleeve includes a plurality of raised structures on its inner surface. The safety clamp comprises a resilient member extending upwardly from the lower portion, through an aperture in the upper portion, the resilient member comprising a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion. Preferably, the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define an angle of less than about 30°, and more preferably the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define a maximum angle of from about 5° to 10°. The securing clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion. Preferably, resilient member is dimensioned so that when the latch member engages the upper portion, the lumen defined by the upper and lower semi-cylindrical members has a predetermined diameter which is substantially equal to that of an outer surface of the endotracheal tube. A first portion of each wing, adjacent the semi-cylindrical portion, extends downwardly (or upwardly) from the horizontal plane, and a second more remote portion of each wing extends outwardly in a plane substantially parallel to the horizontal plane.
In another aspect, the invention features a method of inserting and retaining an endotracheal tube in the tracheal lumen of a patient. The method comprises the steps of: inserting the endotracheal tube through the patient's mouth into the tracheal lumen; providing an endotracheal tube holder comprising upper and lower portions each comprising a semi-cylindrical member and a pair of wings extending radially on opposite sides of the semi-cylindrical member, the upper portion being joined to the lower portion by a flexible hinge extending between a first wing of the upper portion and an opposed first wing of the lower portion, the wings being arranged and dimensioned so that when the hinge is in a closed position, a region of each upper wing is adjacent to a region of a corresponding lower wing, the semi- cylindrical members being arranged and dimensioned so that, when the hinge is in a closed position, the semi- cylindrical members together define a sleeve, the sleeve defining a lumen dimensioned to receive the endotracheal tube; a safety clamp, disposed in a region adjacent the hinge and adapted to limit the extent to which the upper portion and the lower portion can pivot apart about the hinge to a predetermined maximum angle, whereby the position of the endotracheal tube in the housing can be adjusted axially and radial displacement of the endotracheal tube from the endotracheal tube holder is restricted; and a securing clamp disposed in the region spaced further from the hinge and adapted to be moved between a first position, in which the upper portion and the lower portion are allowed to pivot apart to the extent allowed by the safety clamp, to allow for axial adjustment of the endotracheal tube within the lumen while limiting radial movement, and a second position, in which the sleeve engages the tube, thereby also limiting axial movement thereof; closing the safety clamp (without engaging the securing clamp) ; sliding the sleeve of the endotracheal tube holder over the endotracheal tube; adjusting the position of the endotracheal tube holder axially along the length of the endotracheal tube until the endotracheal tube holder is in a desired position; and closing the securing clamp, securing the endotracheal tube holder firmly in position on the endotracheal tube. Preferred embodiments of this aspect of the invention may include one or more of the following additional steps. The steps of securing a neck or head strap to the wings on either side of the housing and fastening the strap about the neck or head of the patient. The step of closing the securing clamp is performed with one hand. The wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of the semi-cylindrical member and a substantially horizontal line taken radially across the semi-cylindrical member. The sleeve includes a plurality of raised structures on its inner surface. The safety clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion. The resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define an angle of less than about 30°, preferably, the resilient member is dimensioned to allow the upper portion and the lower portion to pivot about the hinge to define a maximum angle of from about 5° to 10°. The securing clamp comprises a resilient member which extends upwardly from the lower portion, through an aperture in the upper portion, and which includes a latch member adapted to engage the upper portion and a release member which, when deflected, disengages the latch member from the upper portion. The resilient member is dimensioned so that when the latch member engages the upper portion the lumen defined by the upper and lower semi-cylindrical members has a predetermined diameter which is substantially equal to that of an outer surface of the endotracheal tube. A first portion of each wing, adjacent the semi-cylindrical portion, extends downward from the horizontal plane, and a second more remote portion of each wing extends outwardly in a plane substantially parallel to the horizontal plane. One advantage of the invention is that the holder can be secured relative to the patient, and the tube thereafter secured relative to the holder. Other features and advantages of the invention will be apparent from the following description of presently preferred embodiments, and from the claims.
Brief Description of the Drawings Fig. 1 is perspective view of an endotracheal tube holder according to one embodiment of the invention.
Fig. 2 is a front view of the tube holder of Fig. 1. Fig. 3 is an enlarged cross-sectional view of Detail 3 in Fig. 2.
Fig. 3a is a highly enlarged perspective view of the clamp shown in Fig. 3. Fig. 4 is an enlarged cross-sectional view of Detail 4 in Fig. 2.
Figs. 5 - 5f are views, taken from different angles, of an endotracheal tube holder according to an alternate embodiment of the invention. Figs. 6 - 6f are views, taken from different angles, of an endotracheal tube holder according to a further alternate embodiment of the invention.
Figs. 7 and 8 are partial enlarged cross-sectional side views of latch mechanisms according to alternate embodiments of the invention.
Description of the Preferred Embodiments Referring to Figs. 1 and 2, a preferred endotracheal tube holder 10 of the invention includes an integral housing 12 having a "clamshell" type structure, i.e., housing 12 comprises two halves, upper half 20 and lower half 21, which are joined by a flexible hinge 22. Each half comprises a semi-cylindrical portion 122a, 122b, and a pair of wings 124a, 126a, and 124b, 126b.
When hinge 22 is in a closed position, as shown in Fig. 1, semi-cylindrical portions 122a, 122b form an annular sleeve 14. Sleeve 14 defines a lumen 15, dimensioned to receive an endotracheal tube (not shown) . Sleeve 14 is preferably formed of a rigid, resilient material, e.g., polypropylene, which has sufficient rigidity to act as a bite guard for the endotracheal tube, preventing the patient from damaging or closing the tube by biting down on it, and sufficient resiliency to provide cushioning for patient comfort. Preferably, sleeve 14 has a plurality of longitudinal ribs 18 on its inner surface 11, to provide a more positive grip of the sleeve about the endotracheal tube extending therethrough. A flange 123, having portions 123a, 123b, extends radially from the outer surface of the sleeve in a manner to aid in longitudinal positioning of the sleeve by engaging gently against 'a patient's upper and lower front teeth, as described in more detail below.
Each pair of adjacent wings, i.e., pairs 124a, 124b and pairs 126a, 126b, forms a wing structure 16a, 16b when hinge 22 is in a closed position, as shown in Figs. 1 and 2. The two wing structures curve upwardly, out of a plane defined by the axis of the tube and sleeve 14 and a horizontal line A across the patient's mouth, to allow easy access to the patient's mouth on either side of the housing in a manner to facilitate more thorough and efficient mouth care. Two neck/head strap holders 19 are mounted on the housing, one on each wing, to receive a strap (not shown) which is fastened behind the patient's neck or head.
The diameter of lumen 15 defined by sleeve 14 is determined by the spacing between the semi-cylindrical members. To adjust this spacing, and to hold the upper and lower halves relatively close together, so that the holder can be manipulated with one hand, the housing is provided with a pair of clamps. In the preferred embodiment shown, the housing includes a securing clamp 30 on wing 16b and a safety clamp 28 on wing 16a.
Safety clamp 28, which is closest to hinge 22, is provided to act as a stop, limiting the amount of separation between the two halves, preferably to an extent so that, when the hinge is open to the fullest extent allowed by the safety clamp, a lumen is still defined by the semi-cylindrical portions at least to an extent to prevent radial displacement of the tube from the lumen. However, the safety clamp allows the diameter of the lumen to be increased sufficiently to allow axial adjustment of the endotracheal tube, also without allowing the two halves to become separated, e.g. , so it that is difficult to close them with one hand or so that the tube becomes lodged in the opening. Referring to Fig. 4, safety clamp 28, shown in detail, comprises a resilient member 40 which extends upwardly from wing 124b of the lower half 21 of the housing, through aperture 45 in opposed wing 124a. Resilient member 40 includes a latch member 42 and a release member 44. Wing 124a defines a shoulder 43, positioned for engagement by latch member 42. Resilient member 40 is dimensioned so that, when latch member 42 and shoulder 43 are engaged, as shown in Fig. 4, the two halves of the housing can be separated (pivoted about hinge 22) to define a maximum angle B therebetween. Preferably, angle B is less than about 30°, more preferably angle B is about 5° to 10°. If it is desired to open the two halves beyond the extent allowed by the safety latch, latch member 42 may be released from shoulder 43 by depressing release member 44.
Securing clamp 30, when engaged, clamps the housing around the tube, thereby securely holding the tube against both axial and radial displacement, and, when disengaged, allows the housing to open to the extent allowed by safety clamp 28.
Referring to Figs. 3 and 3a, securing clamp 30, shown in detail, comprises resilient member 32, which extends upwardly from wing 126b of lower half 21, through aperture 33 in wing 126a. Resilient member 32 includes latch member 34 and release member 36. Securing clamp 30 functions in the same manner as does safety clamp 28, i.e., the latch member engages the upper wing until it is released therefrom by depressing the release member. (Apertures in the wings 124b, 126b (Figs. 3a and 4, respectively) facilitate the manufacturing process.) In use, an endotracheal tube is first inserted through the patient's mouth into the tracheal lumen. Then, with the safety clamp open, the sleeve of the holder is slid over the endotracheal tube. The safety clamp is then closed, and, with the securing clamp still open, the position of the holder is adjusted axially along the tube until the holder is in a desired position, preferably with the flange portions engaged gently against the patient's teeth. A neck/head strap, attached to the wings on either side of the housing, is then typically fastened about the neck or head of the patient. When a desired position is achieved, the securing clamp is then closed, typically with one hand, securing the tube firmly in position within the holder. If further adjustment of the holder later becomes necessary, this can easily be accomplished by unfastening the securing clamp, sliding the tube axially within the lumen of the holder, and refastening the securing clamp.
Other embodiments are within the claims. For example, the ribs 18 on sleeve 14 may, in the alternative, be axial or spiral. Where desired for increased security against accidental or inadvertent release, e.g. due to movement or actions by a patient, a second securing clamp may be provided, preferably at right angle to the first securing clamp, thus to require use of two hands for release of the device.
Other alternative embodiments are illustrated in Figs. 5-5f, 6-6f, 7 and 8. As shown in Figs. 5-5f and 6- 6f, the upper and lower members need not be unitary, as shown in Fig. 4, but can instead be separate members 202, 204 joined at a hinge 206. The bite block 208 can extend to any desired extent from the wings, and may be square in cross-section, as shown, or have any desired cross- sectional shape. It may also be desired to cover the bite block with a flexible sheath or a coating or layer of soft material, to improve patient comfort. To accommodate a range of tube outside diameters using a single tube holder, member 204 can have a cantilevered structure so that it can bend in region 210, as shown in Fig. 5d, to adapt to different size tubes.
Alternatively, as shown in Figs. 6-6f, the first and second portions 212, 214, which together define the lumen, can have an semi-elliptical or V-shaped cross- section, rather than a semi-cylindrical shape, to allow tubes having a range of outer diameters to have at least two points of contact with the lumen.
Moreover, although it is generally preferred that the safety clamp and securing clamp be on opposite sides of the lumen (this prevents inadvertent opening of the device by a patient) , the safety clamp and securing clamp can be disposed on the same side of the lumen. This can be accomplished in many ways, as will be appreciated by the artisan. Two examples are shown in Figs. 7 and 8. In Fig. 7, one of the upper and lower members includes step-like detents 216 and the other member includes a resilient member 218 having a protrusion 220 shaped to engage detents 216. Deflection of the resilient member 218, by depressing latch member 222, allows the protrusion to be moved to and engaged with a detent (e.g., 216a) in a position in which the lumen is small enough to securely hold the tube (thus acting as the securing clamp) or with another detent (e.g. , 216b) in a position in which the lumen is large enough to allow the tube to move axially but small enough to retain the tube radially (thus acting as the safety clamp) . This embodiment is also advantageous in that different tube outer diameters can be accommodated by providing many detents, as shown, and selecting an appropriate detent for the given tube diameter to provide each of the securing and safety clamp functions. In one of the many possible alternate embodiments, shown in Fig. 8, one of the upper and lower members includes a plurality of teeth 224, positioned in two spaced sets, and the other member includes a plurality of notches 226 on the other member dimensioned and arranged to engage one set of teeth. By moving the toothed member from a position in which one set is engaged to a position in which the other set is engaged, the size of the lumen can be varied to provide the safety clamp and securing clamp functions.

Claims

CLAIMS:
1. An endotracheal tube holder for retaining an endotracheal tube in a patient's mouth comprising: a first member and a second member, positioned in opposed, spaced relation relative to said first member; said first member comprising a pair of wing members and a first portion disposed between said wing members, said second member comprising a pair of wing members and a second portion disposed between said wing members, said pair of wing members of said first member being dimensioned and arranged so that when the endotracheal tube holder is in a closed position a region of each wing of said first member is adjacent to a region of a corresponding opposed wing of said second member, and said first and second portions being arranged and dimensioned so that when said first and second members are so positioned said first and second portions define a lumen dimensioned to receive the endotracheal tube; a hinge about which said first member can pivot with respect to said second member; a safety clamp, disposed in a region of the opposed wings and including a portion which provides interference engagement between said wings to limit the extent to which said first member and second member can pivot about said hinge to a maximum angle that is sufficiently large to allow the position of the endotracheal tube in the housing to be adjusted axially, and sufficiently small so that said tube cannot be radially displaced from the endotracheal tube holder when the safety clamp is engaged; and a securing clamp disposed in a region of the opposed wings, said securing clamp being movable between a first position, in which said first member and said member are allowed to pivot to the extent allowed by said safety clamp, to allow for axial adjustment of the endotracheal tube within said lumen, and a second position, in which the first portion and the second portion are sufficiently close to each other to engage the tube in a manner to limit axial movement of the tube relative to the endotracheal tube holder.
2. An endotracheal tube holder of claim 1 wherein said first portion and said second portion are semi- cylindrical, and together define a substantially cylindrical lumen.
3. An endotracheal tube holder of claim 1 wherein said first portion and said second portion are semi-oval in cross-section, and together define a lumen which is substantially oval in cross-section.
4. An endotracheal tube holder of claim 1 wherein said first portion and said second portion are V-shaped in cross-section.
5. An endotracheal tube holder of claim l wherein said first member and said second member are separate, and said hinge comprises a fastener joining said first member and said second member, positioned so that said first and second members can pivot about said hinge.
6. An endotracheal tube holder of claim l wherein said first member, second member, and hinge comprise a single unitary part.
7. An endotracheal tube holder of claim 6 wherein said hinge is a flexible member extending between an end of one of said wings on said first member and an end of the opposed wing on said second member.
8. An endotracheal tube holder of claim 1 wherein said wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of said lumen and a substantially horizontal line taken radially across said lumen.
9. An endotracheal tube holder of claim 1 wherein said first and second portion include a plurality of raised structures on their inner surfaces.
10. An endotracheal tube holder of claim 1 wherein said safety clamp comprises a resilient member extending from one of said first and second members towards the opposed member and through an aperture in the opposed member, said resilient member comprising a latch member adapted to engage said upper portion, and a release member which, when deflected, disengages said latch member from said upper portion.
11. An endotracheal tube holder of claim 1 wherein said safety clamp and said securing clamp are on the same side of the lumen defined by the first and second portions.
12. An endotracheal tube holder of claim 11 wherein said safety clamp and said securing clamp are provided by a pair of spaced detents on a single resilient member extending from one of said first and second members, said detents being shaped and positioned to engage a receiving portion of the other of said first and second members.
13. An endotracheal tube holder of claim 1 wherein said safety clamp and said securing clamp are provided on opposite sides of the lumen defined by said first and second portions.
14. An endotracheal tube holder of claim 13 wherein said safety clamp is on the same side of the lumen as the hinge.
15. An endotracheal tube holder for retaining an endotracheal tube in a patient's mouth comprising: an upper portion and a lower portion, said upper portion and said lower portion each comprising a semi-cylindrical member and a pair of wings extending radially on opposite sides of said semi- cylindrical member, said upper portion being joined to said lower portion by a flexible hinge extending between a first said wing of said upper portion and an opposed first said wing of said lower portion, said wings being arranged and dimensioned so that when said hinge is in a closed position, a region of each wing of said upper portion is adjacent to a region of a corresponding opposed wing of said lower portion, and said semi-cylindrical members being arranged and dimensioned so that, when said hinge is in a closed position, the semi-cylindrical members together define a lumen dimensioned to receive the endotracheal tube; a safety clamp, disposed in a region of the opposed wings adjacent said hinge and including means for limiting, by interference engagement, the extent to which said upper portion and said lower portion can pivot apart about said hinge to a predetermined maximum angle, said predetermined angle being sufficiently large to allow the position of the endotracheal tube in the housing to be adjusted axially, and sufficiently small so that said tube cannot be radially displaced from the endotracheal tube holder when the safety clamp is engaged; and a securing clamp disposed in a region of the opposed wings relatively more spaced from said hinge and resiliently movable between a first position, in which said upper portion and said lower portion are allowed to pivot to the extent allowed by said safety clamp, to allow for axial adjustment of the endotracheal tube within said lumen, and a second position, in which the semi-cylindrical members engage the tube in a manner to limit axial movement of the tube relative to said endotracheal tube holder.
16. An endotracheal tube holder of claim 15 wherein said wings are arranged and dimensioned so that a major portion of each wing is removed from a horizontal plane defined by the longitudinal axis of the semi- cylindrical member and a substantially horizontal line taken radially across the semi-cylindrical member.
17. An endotracheal tube holder of claim 15 wherein said semi-cylindrical members include a plurality of raised structures on their inner surfaces.
18. An endotracheal tube holder of claim 15 wherein said safety clamp comprises a resilient member extending upwardly from said lower portion, through an aperture in said upper portion, said resilient member comprising a latch member adapted to engage said upper portion, and a release member which, when deflected, disengages said latch member from said upper portion.
19. An endotracheal tube holder of claim 18 wherein said resilient member is dimensioned to allow said upper portion and said lower portion to pivot about said hinge to define an angle of less than about 30°.
20. An endotracheal tube holder of claim 16 wherein a first portion of each said wing, adjacent said semi-cylindrical portion, extends downwardly from said horizontal plane, and a second, more remote portion of each said wing extends outwardly in a plane substantially parallel to said horizontal plane.
21. A method of inserting and retaining an endotracheal tube in the tracheal lumen of a patient comprising the steps of: inserting the endotracheal tube through the patient's mouth into the tracheal lumen; providing an endotracheal tube holder comprising: an upper portion and a lower portion, said upper portion and said lower portion each comprising a semi-cylindrical member and a pair of wings extending radially on opposite sides of said semi-cylindrical member, said upper portion being joined to said lower portion by a flexible hinge extending between a first said wing of said upper portion and an opposed first said wing of said lower portion, said wings being arranged and dimensioned so that when said hinge is in a closed position, a region of each upper wing is adjacent to a region of a corresponding lower wing, said semi-cylindrical members being arranged and dimensioned so that, when said hinge is in a closed position, the semi-cylindrical members together define a lumen dimensioned to receive the endotracheal tube; a safety clamp disposed in a region adjacent said hinge and adapted, by interference engagement, to limit the extent to which said upper portion and said lower portion can pivot apart about said hinge to a predetermined maximum angle; and a securing clamp disposed in a region spaced further from said hinge; dimensioning and positioning the safety clamp so that the predetermined maximum angle is sufficiently large to allow the position of the endotracheal tube in the housing to be adjusted axially, and sufficiently small so that the tube cannot be radially displaced from the endotracheal tube holder when the safety clamp is engaged; dimensioning and positioning the securing clamp so that it can be moved between a first position, in which the securing clamp is disengaged and the upper portion and the lower portion are allowed to pivot apart to the extent allowed by the safety clamp, and a second position, in which the sleeve engages the tube, to limit axial movement of the tube relative to the lumen; sliding the endotracheal tube holder over the endotracheal tube so that the tube is received in the lumen; closing the safety clamp; with the securing clamp disengaged, adjusting the position of the endotracheal tube holder axially along the length of the endotracheal tube until the endotracheal tube holder is in a desired position; and closing the securing clamp, thereby securing the endotracheal tube holder firmly in position on the endotracheal tube.
PCT/US1995/002564 1993-09-13 1995-03-01 Endotracheal tube holder WO1996026756A1 (en)

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