Source: http://www.google.com/patents/US8220463?dq=6,202,008
Timestamp: 2016-05-06 08:28:41
Document Index: 652599129

Matched Legal Cases: ['art 21', 'art 21', 'art 24', 'art 21', 'art 24', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 35', 'art 32', 'art 32', 'art 40', 'art 40', 'art 49', 'art 49', 'art 49', 'art 40', 'art 40', 'art 32']

Patent US8220463 - Breathing assistance apparatus - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA nasal cannula assembly is disclosed having a face mount part, in use resting against a user's face, which includes at least one nasal prong capable of being fitted into a person's nares. The cannula assembly also includes a manifold part, in fluid communication with the face mount part, having a single...http://www.google.com/patents/US8220463?utm_source=gb-gplus-sharePatent US8220463 - Breathing assistance apparatusAdvanced Patent SearchPublication numberUS8220463 B2Publication typeGrantApplication numberUS 12/389,017Publication dateJul 17, 2012Filing dateFeb 19, 2009Priority dateMay 30, 2003Fee statusPaidAlso published asCA2469117A1, CA2469117C, CA2777608A1, CA2777608C, CA2843533A1, CA2843533C, CA2915201A1, EP1481702A2, EP1481702A3, EP1481702B1, EP2260895A2, EP2260895A3, US7493902, US8267092, US8851076, US20040261797, US20090145435, US20110271962, US20130192605, US20150083125Publication number12389017, 389017, US 8220463 B2, US 8220463B2, US-B2-8220463, US8220463 B2, US8220463B2InventorsCraig Karl White, Jason Peter Van Beurden, Kevin Peter O'DonnellOriginal AssigneeFisher & Paykel Healthcare LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (24), Non-Patent Citations (1), Referenced by (6), Classifications (30), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetBreathing assistance apparatus
US 8220463 B2Abstract
1. A breathing assistance apparatus for supplying gases to a patient comprising:
a gases supply capable of supplying gases to said patient,
a humidifier to humidify said gases,
an inspiratory conduit to transport gases from said gases supply and said humidifier to said patient, a patient interface capable of directing said gases to the patient's airway passages, a breathable tube disposed between said inspiratory conduit and said patient interface.
2. A breathing assistance apparatus as claimed in claim 1 wherein said breathable tube is constructed from a hydrophilic material.
3. A breathing assistance apparatus as claimed in claim 1 wherein said breathable tube is a short section of tube.
4. A breathing assistance apparatus as claimed in claim 1 wherein said patient interface is a nasal cannula.
5. A breathing assistance apparatus as claimed in claim 1 wherein said patient interface is a nasal cannula capable of allowing gases to be supplied to said patient up to flows of 60 liters per minute.
6. A breathing assistance apparatus for supplying gases to a patient comprising:
an inspiratory conduit to transport gases from said gases supply and said humidifier to said patient,
a patient interface capable of directing said gases to the patient's airway passages,
a short section of breathable tube disposed between said inspiratory conduit and said patient interface, said short section of breathable tube constructed from a hydrophilic material.
7. A breathing assistance apparatus for supplying gases to a patient comprising:
a nasal cannula capable of directing said gases to the patient's airway passages, a short section of breathable tube disposed between said inspiratory conduit and said patient interface, said short section of breathable tube constructed from a hydrophilic material.
8. A breathing assistance apparatus for supplying-gases to a patient comprising:
a nasal cannula capable of directing said a gases flow of up to 60 liters per minute to the patient's airway passages,
a short section of breathable tube disposed between said inspiratory conduit and said patient interface, said short section of breathable tube constructed from a hydrophilic material. Description
This application is a continuation of U.S. patent application Ser. No. 10/855,146, having a filing date of May 27, 2004 and entitled “Breathing Assistance Apparatus”. The disclosure of U.S. patent application Ser. No. 10/855,146 is herein incorporated by reference.
The present invention relates particularly, though not solely, to the delivery of high flow humidified pressurised oxygen and/or air to a patient in need of respiratory support by way of a nasal cannula.
Oxygen is generally supplied as a dry gasp but it is well known in the art to either heat and/or humidify gases before delivering them for breathing by a patient. In particular when delivering oxygen, or an oxygen air mixture, it has proven beneficial to humidify the gases first. In WO 01/41854 of Vapotherm, Inc. a system is disclosed that allows the delivery of humidified oxygen through a nasal cannula. This system uses a narrow bore conduit and nasal cannula with a high resistance to gas flows, thereby requiring the oxygen be of a high pressure. Air, as well as oxygen, can also be passed down the conduit and nasal cannula and it too must be of a high pressure. This system allows the delivery of high flows of oxygen enriched air to the patient, but is limited in the flows achievable due to the narrow bore of the cannula resulting in high resistance gas flow and excessive velocity and noise upon exiting the cannula. Furthermore, the narrowness of the nasal cannula in this system allows the patient to easily expire gases from their nostrils as there is a reasonable gap between the prongs and the patient's nares. Thus positive airway pressure is not created and as such this cannula is not suitable for the treatment of Obstructive Sleep Apnea (OSA).
In breathing circuits that supply respiratory gases to a patient by way of a patient interface, such as a nasal cannula, mask or tracheal tube, it is common, to have a heated breathing circuit or tube delivering heated and humidified gases to the patient, followed by a short length of non-heated tube close to the patient. This unheated tube may be a short unheated extension tube or catheter mount. The unheated section of tube is usually intended to be very flexible to reduce torsion or pulling on the patient interface, to allow the gases to cool slightly towards the dew point of the gas, and also to eliminate hot surface temperatures near the patient. As this tube is unheated the temperature of the tube walls are colder than the dew point temperature of the gas, as a result the vapour in the gases passing near these walls will begin to condense out. Over time a build up of condensate close to the patient may lead to a build-up of bacteria which may cause infection. Build up of condensation may also create noise, such as gurgling, which may wake a patient, and in extreme circumstances the fluid build up may cause drowning.
humidification means adapted to, in use, be in fluid communication with said source of gases and adapted to in use humidity said gases,
FIG. 15 is a perspective view of a tracheostomy fitting.
FIG. 16 is a front view of a patient with a tracheostomy and fitting attached to a breathing supply where a neck tie or lanyard is used to support the conduit supplying gases to the patient.
Whether used in a hospital environment or in a home environment the nasal cannula assembly of the present invention will generally have associated three main pieces of apparatus. Firstly an active humidifier that controls the temperature of a heater plate heating a body of water to achieve a desired temperature and humidity of the gases being humidified. Secondly a transport conduit from the humidifier to the patient is also required, which is preferably heated to reduce condensation, or “rain out”. Thirdly a nasal cannula designed to fit into the nasal cavity of a patient or user and deliver humidified, pressurized gases.
Referring to FIG. 1 a humidifying circuit as might be used with the nasal cannula of the present invention is shown. A patient 1 is receiving humidified and pressurised gases trough a nasal cannula 20 connected to a humidified gases transportation pathway or inspiratory conduit 3 that in turn is connected to a humidifier 8 (including humidification chamber 5) that is supplied with gases from a blower 15 or other appropriate gases supply means. The inspiratory conduit 3 is connected to the outlet 4 of a humidification chamber 5 which contains a volume of water 6. Humidification chamber 5 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8. The humidifier 8 is provided with control means or electronic controller 9 which may comprise a microprocessor based controller executing computer software commands stored in associated memory. Gases flowing through the inspiratory conduit 3 are passed to the patient by way of the nasal cannula 20.
Controller 9 receives input from sources such as user input means or dial 10 through which a user of the device may, for example, set a predetermined required value (preset value) of humidity or temperature of the gases supplied to patient 1. In response to the user set humidity or temperature value input via dial 10 and other possible inputs such as internal sensors that sense gases flow or temperature, or by parameters calculated in the controller, controller 9 determines when (or to what level) to energise heater plate 7 to heat the water 6 within humidification chamber 5. As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 5 outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. It should be noted that it is possible to obtain the relationship between the humidity of the gases in humidification chamber 5 and the temperature of the heater plate 7. Accordingly, it is possible to utilise the heater plate temperature in an algorithm or a look-up table to determine the humidity of the gases.
A heating element 11 may be provided within the conduit or tubing 3 to help prevent condensation of the humidified gases within the conduit. Such condensation is due to the temperature of the walls of the conduit being close to the ambient temperature, being the temperature of the surrounding atmosphere) which is usually lower than the temperature of the humidified gases within the conduit. The heater element is effectively replaces the energy lost from the gases through conduction and convection during transit through the conduit. Thus the conduit heater element ensures the gases delivered are at an optimal temperature and humidity.
A first form of the nasal cannula assembly of the present invention is shown in FIGS. 2 and 3. This nasal cannula, generally indicated as 20, comprises a face mount part 21 including a pair of tubular nasal prongs 22, 23 integrally molded with or removably attached to the face mount part 21, and a gases flow manifold part 24 that is integrally molded with or attached to tubing 3, such as that described above.
The face mount part 21 and prongs 22, 23 are preferably moulded from silicone or other flexible material as is known is the art of cannula construction. The gases flow manifold part 24 is preferably made from a hard plastics material, although it may be manufactured in other suitable materials.
The face mount part 21 is preferably integrally molded with the prongs 22, 23 and is shaped to generally follow the contours of a patient's face around the upper lip area. The inner side (not shown) of the face mount part 21 may be provided with a breathable pad, to be described below. The outer side 25 of the face mount part 21 has moulded in it an elongated oval recess 26 and two oval recesses 27, 28 that extend through the face mount part 21 and each meet the tabular passageway's formed within each of the tubular prongs 22, 23.
The nasal cannula assembly of the present invention is more comfortable to wear as it sits under the septum of the nose and supports the two nasal prongs. As the prongs are made in one moulding of a soft material such as silicone the prongs are easy to insert in the patient's nares and comfortable to the patient.
For a nasal cannula assembly to be suitable for wearing during sleep each night the cannula must be noise free. Many prior art cannulas are prone to whistling. With a range of airflows generally being between 0 to 40 liters per minutes although airflows of 60 liters per minute are envisaged for the present nasal cannula, and with the air or gases being supplied to a single horizontal entry point it has proved difficult to prevent whistling. For this reason the face mount part 21 is contoured such that the pressure distribution within the face mount part 21 forces even airflows up each nasal prong.
Reference is now made to FIGS. 4 to 7 that show a second form of the nasal cannula assembly of the present invention. In this form the nasal cannula assembly 30 is of a substantially similar form to the first form described above in relation to FIGS. 2 and 3, and has a face mount pan 32, a pair of nasal prongs 33, 34, gases flow manifold part 35 and tubing 3. The face mount part 32 and pair of nasal prongs 33, 34 are preferably integrally molded as one piece from a soft plastics material such as silicone, although in other forms the face mount part and prongs may be separate, but capable of attachment together for use.
The pad 36 is preferably attached to the face mount part 32 by adhesive, for examples the pad could be supplied with a sticky backing that adheres to the face mount part, so that the pad can be easily removed from the face mount part and replaced as necessary.
Next, a pair of soft nasal prongs 41 or 42 are provided that are capable of being attached to the top of the gases flow manifold part 40 allowing for a large range of different shaped and spaced prongs to be available to the patient. Two such configurations of prongs 41, 42 are shown in FIGS. 10 and 11. The prongs 41 of FIG. 10 are narrow elongate tubular members 43, 44 of a substantially constant diameter that are fittable into a patient's nares. The prongs are integrally molded with a body 45 that is fittable with the gases flow manifold part 40 (see FIG. 8) by appropriate means, for example, friction or snap fit. The prongs 42 of FIG. 11 are tapered tubular members 46, 47 moulded to a body 48. Again, this body 48 is capable of being fitted (friction, snap or other) to the gases flow manifold part of FIG. 8. These prongs are preferably made from a soft plastics material such as silicon, although other suitable materials may be used.
The third part to the third form of the nasal cannula assembly shown in FIGS. 8 to 11 is the face mount part 49 of FIG. 9. The face mount part 49 comprises a head strap 53 attached to a pad 50, that may be a moulded or shaped substantially rigid pad, for example, made from a plastics material such as polypropylene. The pad 36 may include a breathable cloth pad on its surface that abuts a patient's face, similar to that pad 36 described in relation to FIG. 7, or the head straps 53 may extend to sit behind the pad. The head strap 53 is preferably made from a flexible material, such as neoprene.
The plastic pad 50 is shown in FIG. 9 and has a plurality of apertures 61 formed into to allow for heat and moisture to dissipate from the patient's facial surface. The pad 50 has fastening means 51, 52 for holding the gases flow manifold part 49 in the correct position on the upper lip of the patient. The fastening means may be clips 51, 52 that are fittable into complimentary recesses 54, 55, 56, 57 provided in or on the manifold part 40 (see FIG. 8), but other appropriate fastening means may be provided with the cannula. An example of other fastening means is a loop that is integrally moulded as part of the prongs which wraps around the face mount part and latches over a protrusion on the manifold part thus encapsulating the face mount part and holding the assembly together stably and securely. Another example of a fastening means is a plastic Velcro™ type attachment where one side would attach to one side of the manifold part 40 and the other side to the plastic pad 50. For the fastening means shown in FIGS. 8 and 9 at least one recess must be provided on either side of the manifold 40. In the preferred form of the nasal cannula assembly two recesses 54, 55 are provided on one side of the manifold 40 and two other recesses 56, 57 on the other side of the manifold 40.
Often an unheated flexible section of tubing is placed proximal to the patient to reduce torsion or pulling on the patient interface and reduce possible heat problems or over heating close to the patient. In order to reduce condensate forming in the unheated tubing, tubing can be provided that has vapour transmission properties. Referring now to FIG. 12 the nasal cannula of the present invention (in particular, that of the second form described herein) may be provided with a short piece of breathable tubing 62 between the nasal cannula 30 and heated tubing 3. The tubing 62 is preferably made from a material that allows for transmission of water, such as a hydrophilic material, for example SYMPATEX™.
The result of providing the short section of breathable tubing 62 is that a majority of humidity in the gases is transported to the patient, and there is an insignificant and immeasurable toss of humidity through the breathable wall of the short tube 62, while condensate is reduced. The design of the high airflow high humidity system has been optimized to deliver a breathable gas treatment to patients at temperatures approximating body temperature and fully saturated with water vapour for long treatment periods. The use of an unheated breathable conduit proximal to the patient to provide a connection that is highly flexible and avoids condensation by breathing would be expected to lower the humidity of the gas treatment thereby decreasing the efficacy of the treatment. These results are surprising and are counterintuitive and go some way to explaining why the use of a breathable tube as a short section of tubing before the patient has been overlooked. This short tube 62 is envisaged to be used with any tube delivering heated and humidified gases to a patient.
The tie or lanyard described may be used with any breathing apparatus that supplies gases to a patient; for example it may be used with a nasal or face mask or with a tracheostomy fitting or connector. When the tie or lanyard is used with such apparatus it takes the weight of the conduit(s) or tubing supplying gases to the mask, connector or cannulae and helps reduce the pull on the mask, connector or cannulae.
FIGS. 15 and 16 show a tracheostomy fitting or connector that may utilise a neck tie or lanyard of the present invention. The tracheostomy connector 69 attaches to a tracheostomy mount 72 that extends into a tracheostomy tube (not shown) through hole in a patient's 68 neck and into their airway passages. The connector 69 provides a direct coupling of a tracheostomy tube to the breathing supply of gases received through a conduit 71. Preferably the conduit 71 is constructed in a breathable material, similar to that described above, but may be a heated tube.
Excess weight on the tracheostomy tube may cause excess movement of the tube, with the risk of complications such as displacement or recannulation of the tracheostomy, the formation of granulation tissue or more seriously, stomal erosion. To obviate or reduce these problems a tie or lanyard 73 can be connected to the conduit 71 or additional connector 74 (that may for example connector the conduit 71 to an additional conduit 75 that supplies gases). The tie or lanyard 73 transfers the weight of the conduits 71, 75 and connector 74 from the tracheostomy tube or mount 72 and distributes it onto the neck of the patient leaving a minimal load directly on the tracheostomy tube or mount 72. Preferably the tie or lanyard 73 is adjustable so that the tie or lanyard length can be altered to suit a patient's requirements.
The loops 65, 66 extend from the face mount part 32 around the patient's ears, and provide rigid anchoring when an inelastic material is use. The loops 65, 66 are preferably made from a thin, round cord with the ends captured in plastic, and are preferably adjustable. The plastic ends of the loops 65, 66 are inserted into purpose made cavities in the straps 31, enabling adjustment of length for a comfortable, yet firm fit.
In use, to fit the nasal cannula assembly, a first loop (for example, loop 65) is placed over one ear, the nasal cannula assembly positioned on the patient's face and in their nose, then the other ear is passed through the second loop (for example, loop 66), so both loops sit snugly behind the ears. This method of fitting the nasal cannula avoids the initial discomfort of gases being blown into the patient's eyes when the cannula assembly is pulled down the face for fitting with other headgear. Fastening the nasal cannula in this method provides an attachment mean that is horizontally secure with minimum tension applied to the ear connection loops. The ear loops have the added advantage for a patient lying on their back that there are no straps behind the back of the head that are moved by head movement on the pillow.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS2868199May 20, 1955Jan 13, 1959Hudson Charles HCannulaUS3513844Apr 30, 1968May 26, 1970Metro Hospital Supply Co IncAdjustable nonrestrictive nasal cannulaUS3682171Mar 31, 1971Aug 8, 1972Baxter Laboratories IncNasal cannulaUS3754552Jun 8, 1971Aug 28, 1973Sandoz AgFlexible nasal cannulaUS4216769Sep 29, 1978Aug 12, 1980Grimes Jerry LBi-flow nasal cupUS4509359Dec 10, 1982Apr 9, 1985Gambro Engstrom AbMethod and apparatus for measuring the concentration of a given component in a gas inhaled and/or exhaled by a patientUS4705543 *Sep 19, 1986Nov 10, 1987Perma Pure Products, Inc.Fluid drying tubeUS4753233Feb 10, 1987Jun 28, 1988Advantage MedicalNasal cannulaUS4995384Oct 30, 1989Feb 26, 1991Keeling James LNeck support for nasal cannulaUS5042500Jun 18, 1990Aug 27, 1991Medical Graphics CorporationDrying sample lineUS5165395Feb 14, 1992Nov 24, 1992Ricci Mark RUltra-violet germicidal mask systemUS5513634May 6, 1994May 7, 1996Chek-Med Systems, Inc.Combination integral bite block airway and nasal cannulaUS5595174Feb 28, 1994Jan 21, 1997Gwaltney; Max R.Nasal adaptor, mask, and methodUS6637434Jun 28, 2002Oct 28, 2003Linda J. NobleNasal gas delivery system and method for use thereofUS7493902May 27, 2004Feb 24, 2009Fisher & Paykel Healthcare LimitedBreathing assistance apparatusUS20020046755Nov 13, 2001Apr 25, 2002Torsten De VossGas-supplying deviceUS20020059935Jan 15, 2002May 23, 2002Wood Thomas J.Ventilation interface for sleep apnea therapyUS20030047185Sep 13, 2002Mar 13, 2003Olsen Gregory JamesBreathing assistance apparatusUSRE40806 *Jul 27, 2004Jun 30, 2009Fisher & Paykel Healthcare LimitedRespiratory humidification systemDE28036C Title not availableEP1166814A2Jun 21, 2001Jan 2, 2002FISHER &amp; PAYKEL LIMITEDConduit with heated wickFR2638361A1 Title not availableJPH10248935A Title not availableWO2001041854A2Dec 8, 2000Jun 14, 2001Vapotherm, Inc.Apparatus and method for respiratory tract therapy* Cited by examinerNon-Patent CitationsReference1Canadian Examination Report; Mar. 23, 2011; 3 pages.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8770199Dec 4, 2013Jul 8, 2014Ino Therapeutics LlcCannula for minimizing dilution of dosing during nitric oxide deliveryUS8851076 *Aug 22, 2012Oct 7, 2014Fisher & Paykel Healthcare LimitedBreathing assistance apparatusUS9032959Dec 4, 2013May 19, 2015Ino Therapeutics LlcCannula for minimizing dilution of dosing during nitric oxide deliveryUS9199053 *Jan 31, 2012Dec 1, 2015Breathe Technologies, Inc.Methods, systems and devices for ventilation using a nasal ventilation mask with a manifold and internal compliant tube and nasal sealing cushion assemblyUS20110303224 *Dec 15, 2011Widgerow Alan DSkin adherent medical devicesUS20130192605 *Aug 22, 2012Aug 1, 2013Fisher & Paykel Healthcare LimitedBreathing assistance apparatus* Cited by examinerClassifications U.S. Classification128/207.18, 128/203.17, 128/204.17International ClassificationA61M16/08, A61M16/16, A61M11/00, A61M16/00, A61M16/06, A61M16/10Cooperative ClassificationA61M16/0003, A61M16/109, A61M16/16, A61M16/0622, A61M16/0688, A61M16/0816, A61M2205/3368, A61M16/0672, A61M16/0415, A61M2205/52, A61M2205/3334, A61M16/0683, A61M2202/0208, A61M2016/003, A61M16/0057, A61M16/0666, A61M16/08, A61M16/1095European ClassificationA61M16/06L, A61M16/08, A61M16/06SLegal EventsDateCodeEventDescriptionApr 13, 2009ASAssignmentOwner name: FISHER & PAYKEL HEALTHCARE LIMITED, NEW ZEALANDFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WHITE, CRAIG KARL;VAN BEURDEN, JASON PETER;O DONNELL, KEVIN PETER;REEL/FRAME:022539/0010;SIGNING DATES FROM 20040615 TO 20040616Owner name: FISHER & PAYKEL HEALTHCARE LIMITED, NEW ZEALANDFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WHITE, CRAIG KARL;VAN BEURDEN, JASON PETER;O DONNELL, KEVIN PETER;SIGNING DATES FROM 20040615 TO 20040616;REEL/FRAME:022539/0010Nov 19, 2015FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services