Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
  • A61M16/0666—Nasal cannulas or tubing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
  • A61M16/0683—Holding devices therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/06—Head
  • A61M2210/0618—Nose

Definitions

• the present invention relates to the field of devices and methods for holding breathing devices and the like in place on a perso ' s head.
• Breathing devices such as masks and the like, typically are held in place on a person's face by a harness including one or more straps extending around the person's head and along the side of the person's face.
• Known devices have a variety of drawbacks. If the strap system is complex, it may not be obvious to the prospective wearer how to properly use the system, and elderly patients may struggle with putting on a mask when help is not present. A strap system which is incorrectly adjusted may result in improper positioning of the mask or excessive pressure to the skin.
• straps may contact sensitive regions of the face, resulting in abrasions or contact dermatitis over time. Additionally, straps may obscure portions of the face, causing distress to the wearer from a personal and aesthetic point of view. This can contribute to lack of compliance with wearing of the mask.
• a device for positioning a breathing apparatus in communication with (i.e., over or within) a breathing orifice in the head of a person, the head of the person having an occipital lobe and an axis of symmetry.
• the device comprises an occipital anchor structure for anchoring against the head of the person about (i.e., beneath or against) the occipital lobe of the person, a forward anchor member for anchoring against a corresponding portion of the person's head at a forward anchoring position selected from the group consisting of a first portion of the persons head proximally surrounding said orifice (such as an area surrounding the nose and/or mouth, including the bridge of the nose) and a region located from the top portion of the person's head to the forehead portion of the person's head, and a biasing structure (such as a spring, array of springs, or other biasing member) connecting the forward anchor and the occipital anchor.
• a biasing structure such as a spring, array of springs, or other biasing member
• the biasing structure biases the occipital anchor against the head of the person beneath the occipital lobe and biases the forward anchor against the corresponding portion of the person's head so as to attach the device to the person's head.
• the occipital anchor, the forward anchor and the biasing structure are substantially aligned along the axis of symmetry of the person's head.
• a mounting member also is connected to the biasing structure for mounting said apparatus so as to locate the apparatus over said orifice.
• Fig. 2 shows details of a mask for use with the present invention including a pair of nostril-tubes for sealingly fitting within corresponding nostrils of a person's nose.
• Fig. 3 is a side elevation view of a device in accordance with another embodiment of the invention.
• Fig. 4 is a schematic side elevational view of still another embodiment of the invention.
• Fig. 5 is a schematic side elevational view of a further embodiment of the invention.
• Fig. 6 is a schematic side elevational view of yet another embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION
• the present invention provides a novel device and method for positioning an apparatus over a portion of a person's head.
• the invention generally is for positioning a head orifice- interacting apparatus over an orifice of the person's head.
• the present invention is particularly applicable to devices to control sleep apnea, or to assist in breathing.
• the invention is for positioning a breathing device such as a breathing mask or respirator mask for covering at least one facial member selected from the group consisting of a person's nose, a person's mouth and a combination thereof.
• a breathing device such as a breathing mask or respirator mask
• the invention can also be applied for positioning an apparatus over a person's ear or ears, such as a listening apparatus; or for positioning an apparatus over a person's eye or eyes such as a viewing apparatus.
• the device can be utilized for positioning a speaking apparatus over a person's mouth, or any combination of the above.
• the device of the invention is provided for attaching a breathing mask over a person's nose, mouth or both.
• a device 10 in accordance with the present invention includes an occipital anchor 12 for anchoring against the inian portion of the person's head beneath the occipital lobe 14 of a person's head 16 shown in Figs. 3 and 4.
• the occipital anchor 12 can have a length LI within a range of about 2-8 centimeters, preferably about 3-7 centimeters, and a width l within a range of about 5 to 20 centimeters, preferably about 8-12 centimeters.
• the device 10 includes a forward anchor member 18 for anchoring against a corresponding portion of the person's head selected from the group consisting of a top portion of the person's head 20 shown in Fig. 3, and a forehead portion 22 of a person's head shown in Fig. 4.
• the forward anchor 18 can have a length L2 within a range of about 1 to 4 centimeters, preferably about 2 to 3 centimeters, and a width W2 within a range of about 5 to 11 centimeters, preferably about 7 to 9 centimeters.
• the device 10 includes a biasing structure 24 connecting the forward anchor member 18 and the occipital anchor 12.
• the biasing structure 24 biases the occipital anchor against the occipital lobe and the forward anchor against the top portion or the forehead portion of the person's head, so as to attach the device to the person's head.
• the occipital anchor 12, the forward anchor 18 and the biasing structure 24 are substantially aligned along the axis A of symmetry of the person's head, which is in line with the plane of Fig. 4.
• the biasing structure 24 extends between the occipital anchor 12 and the forward anchor 18 a distance within the range of about 7-30 centimeters, preferably about 10-18 centimeters.
• the biasing structure 24 can be formed of spring steel, and as shown in Fig. 1, the distance between the occipital anchor 12 and the forward anchor 18 can be adjusted by spring 26 sliding within slot 28 of scabbard member 30.
• a mounting member 32 is connected to the biasing structure 24 for mounting a breathing mask 34, which in this case is a nostril mask 34A, to sealingly engage the nostril mask with a person's nostrils.
• the mounting member 32 can extend between the forward anchor 18 and the breathing mask 34 a distance within the range of about 10 to 25 centimeters, preferably about 15 to 20 centimeters.
• the device 10 has a second scabbard member 36 with a slot 38 within which the spring member 26 is slidable for adjustment of the device.
• Fig. 2 shows a breathing mask 34B which is a Nasal Pillows TM type including a pair of nostril-tubes 40 for sealingly fitting within corresponding nostrils of a person's nose.
• a breathing mask 34B which is a Nasal Pillows TM type including a pair of nostril-tubes 40 for sealingly fitting within corresponding nostrils of a person's nose.
• Fig. 3 shows a breathing mask 34C which sealingly covers both the patient's nose and mouth, the mounting member 32 being capable of biasing the breathing mask 34C so as to form a seal around the nose and mouth orifices.
• a gas plenum 42 is provided, as shown in Figs. 2, 3 and 4.
• the embodiment shown in Fig. 1 shows structure for attaching a gas plenum to mounting member 32, including rings 44.
• the gas plenum is attached to the mounting member 32 and connectable to the breathing mask 34 for delivering gas to and from the breathing mask 34.
• the gas plenum can be formed as an integral part of mounting member 32.
• the plenum 42 can have any suitable cross-sectional area, for example, within a range of about 100 to 500 mm 2 .
• the air plenum 42 is approximately 46 centimeters long and has a circular cross- section of 15 mm, with a cross-sectional area of about 175 mm 2 .
• the device 10 consists essentially of the occipital anchor 12, forward anchor 18, biasing structure 24 and mounting member 32, with the occipital anchor, forward anchor, biasing structure and mounting member being essentially the only means for attaching the breathing mask 34 to the person's head, the device being otherwise substantially free of any other means for securing the device to the person's head.
• the device 10 is adapted to apply a force normal to the occipital anchor within a range of about 300-1,500 gm, with a preferred nominal force normal applied to the occipital anchor structure of about 800 gm.
• the preferred device is adapted to apply a force normal to the forward anchor 18 within a range of about 300 to 1,200 gm, with a nominal force normal applied to the forward anchor 18 of about 500 gm.
• the force normal applied to the breathing mask depends on whether the breathing mask is a Nasal Pillows TM (nostril-tube) type or a perimeter-type mask extending completely around the nose and mouth.
• a Nasal Pillows TM type of mask the goal is to minimize the force normal, whereas for a perimeter mask, a substantial force normal is required to make a sufficient air seal.
• a force normal applied to the breathing mask generally is within a range of about 0-1,000 gm, with a nominal force normal of about 100 gm being most preferred.
• a device as shown in Fig. 1 preferably is adapted so that the lateral force necessary to cause side slippage on a person's head is within the range of about 200 to 500 gm, with a nominal lateral force necessary to cause side slippage of greater than about 300 gm.
• a side strap 48 can be provided as shown in Fig. 4, passing around the sides of the head and connecting the occipital anchor 12 with the mounting member 32.
• Side strap 48 preferably is formed of cloth or elastomeric material.
• Figs . 4 and 5 show an embodiment where the forward anchor member 18A is comprised of the breathing apparatus such as mask 34D.
• the spring force of biasing structure 24 holds the apparatus in place by pressure of face mask 34D against the front of the face and by pressure of occipital anchor 12 against the occipital lobe 14.
• a compliant sling 52 can be provided, having opposite ends connected to forward and rear portions of the biasing structure 24 as shown in Fig. 6.
• Sling 52 contacts the persons head when the breathing apparatus such as face mask 34D is located over the person's nose and/or mouth.
• Sling 52 provides frictional force at the top of the head, to aid in preventing the device from slipping sideways.
• the sling may be formed of any suitable compliant material such as fabric, plastic or the like, and may be elastic, inelastic or spring loaded.
• Sling 52 may also assist in rendering the device self- centering, wherein a perturbing lateral force is met by an opposing compensating force, so as to resist lateral slippage.
• a perturbing lateral force is met by an opposing compensating force, so as to resist lateral slippage.
• vent 46 which is sized so that continuous positive airway pressure (CPAP) within the plenum flushes the hose and the plenum between breaths.
• CPAP continuous positive airway pressure
• a carbon dioxide vent is generally disclosed in U.S. Patent No. 5,065,756, reissued as RE. 35,339, incorporated herein by reference.
• the method of the present invention utilizing a device as shown in the figures includes the steps of positioning the occipital anchor against a person's occipital lobe, positioning the forward anchor against the corresponding portion of the person's head, and positioning the breathing mask over the person's nose, mouth or both, with the occipital anchor, the forward anchor and the biasing structure substantially aligned along the axis of symmetry of the person's head, and with the occipital anchor, forward anchor and breathing mask biased against the corresponding portions of the patient's head.
• the method of the invention includes the step of connecting the gas plenum 42 to a continuous source of respiratory gas 50, shown schematically in Fig. 4.
• the method further includes the step of removing expired gas containing carbon dioxide from the gas plenum through vent 46 when the person exhales.

Landscapes

• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Emergency Medicine (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Otolaryngology (AREA)
• Respiratory Apparatuses And Protective Means (AREA)
• Gear-Shifting Mechanisms (AREA)
• Manipulator (AREA)
• Sampling And Sample Adjustment (AREA)

Priority Applications (6)

Applications Claiming Priority (4)

Publications (2)

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Family Applications (1)

Country Status (9)

Cited By (26)

Families Citing this family (71)

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• 2000
  • 2000-03-07 AT AT00970428T patent/ATE296658T1/de not_active IP Right Cessation
  • 2000-03-07 EP EP00970428A patent/EP1204440B1/en not_active Expired - Lifetime
  • 2000-03-07 WO PCT/US2000/005867 patent/WO2001000266A2/en not_active Ceased
  • 2000-03-07 DE DE60020568T patent/DE60020568T2/de not_active Expired - Fee Related
  • 2000-03-07 CA CA002365348A patent/CA2365348A1/en not_active Abandoned
  • 2000-03-07 AU AU79812/00A patent/AU770324B2/en not_active Ceased
  • 2000-03-07 ES ES00970428T patent/ES2243312T3/es not_active Expired - Lifetime
  • 2000-03-07 JP JP2001505973A patent/JP4834867B2/ja not_active Expired - Fee Related
• 2001
  • 2001-05-02 US US09/846,256 patent/US6516802B2/en not_active Expired - Lifetime

Non-Patent Citations (1)

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