Various embodiments of the invention described herein relate to the field of systems, devices, components, and methods for improving acoustic coupling of bone conduction hearing devices to patient's heads and skulls.
In some cases, an external magnetic “bone conduction hearing device” (“BCHD”) is held in position on a patient's head by means of magnetic coupling that occurs between one or more magnetic members included in a baseplate or spacer of the BCHD and a magnetic implant that has been implanted beneath the patient's skin and affixed to the patient's skull. Acoustic signals originating from a transducer located in the external magnetic BCHD are transmitted through the baseplate or spacer (which is coupled to the transducer of the BCHD) and through the patient's skin to bone in the vicinity of the underlying magnetic implant, and then through the skull bone to the patient's cochlea. The acoustic signals generated and delivered by the transducer to the baseplate or spacer are provided in response to external ambient audio signals detected by one or more microphones disposed in external portions of the hearing aid, which are processed by a processor in the BCHD and provided to the transducer. The transmission of acoustic signals from the BCHD to the patient's bone occurs through skin and other tissue overlying the bone, and may also be through hair disposed between the baseplate or spacer and the magnetic implant.
In other cases, the BCHD is not secured to the patient's head through magnetic means, but instead is secured or attached to the patient's head by mechanical means, such as by a headband, a strap and/or adhesive.
Whether or not magnetic coupling means are employed to secure a BCHD to a patient's head or skull, a perennial difficulty has been the degree and quality of acoustic coupling that is capable of being achieved between a BCHD and a patient's skull or head. Poor acoustic coupling of EM transducer signals through a patient's skin and/or hair can occur, which results in substandard transmission of such signals to the patient's skull.
What is needed is a BCHD or BCHD system that somehow provides improved acoustic coupling between the BCHD and a patient's head or skull.
In one embodiment, there is provided a method of improving acoustic coupling between a bone conduction hearing device (BCHD and a patient's head or skull, the BCHD comprising a transducer configured to generate sound signals for transmission to the patient's skull, the method comprising applying an aqueous gel or paste to a bottom surface of the BCHD, and attaching, securing or magnetically coupling the BCHD to or against the patient's head or skull, wherein at least portions of the gel or paste are operably disposed between the bottom surface of the BCHD and the patient's head or skull thereby to improve acoustic coupling and transmission of the sound signals generated the transducer to the patient's skull.
In another embodiment, there is provided a bone conduction hearing device (BCHD) comprising a transducer configured to generate sound signals for transmission to the patient's skull, a bottom surface, and an acoustic coupling gel or paste disposed on at least portions of the bottom surface, wherein when the BCHD is attached, secured or magnetically coupled to a patient's skull or head at least portions of the acoustic coupling gel or paste are disposed between the bottom surface and the patient's head or skull thereby to improve acoustic coupling and transmission of sound signals originating from the transducer to the patient's skull.
In yet another embodiment, there is provided a bone conduction hearing device (BCHD) kit comprising a BCHD comprising a transducer configured to generate sound signals for transmission to the patient's skull and a bottom surface, and an acoustic coupling gel or paste configured to be disposed on at least portions of the bottom surface, wherein when the BCHD is attached, secured or magnetically coupled to a patient's skull or head at least portions of the acoustic coupling gel or paste can be disposed between the bottom surface and the patient's head or skull thereby to improve acoustic coupling and transmission of sound signals originating from the transducer to the patient's skull.
In still another embodiment, there is provided an aqueous acoustic coupling gel or paste configured for use with a bone conduction hearing device (BCHD), the gel or paste comprising a substantially cross-linked system of one or more polymers, the gel having a viscosity sufficient to stick to a bottom surface of the BCHD after having been disposed thereon by a user, the BCHD comprising a transducer configured to generate sound signals for transmission to a patient's skull, wherein the gel is configured for use in conjunction with the BCHD by being disposed over at least portions of the bottom surface and between the bottom surface and the patient's skull when the BCHD is secured, attached or magnetically coupled to the patient's head or skull, and the gel is further configured to improve acoustic coupling and transmission of sound signals originating from the transducer to the patient's skull.
Further embodiments are disclosed herein or will become apparent to those skilled in the art after having read and understood the specification and drawings hereof.
Different aspects of the various embodiments will become apparent from the following specification, drawings and claims in which:
The drawings are not necessarily to scale. Like numbers refer to like parts or steps throughout the drawings.
Described herein are various embodiments of systems, devices, components and methods for bone conduction and/or bone-anchored hearing aids.
A bone-anchored hearing aid (“BAHA”), also referred to as a bone conduction hearing device (“BCHD”), is an auditory prosthetic device based on bone conduction having a portion or portions thereof which are surgically implanted. A BAHA or BCHD uses the bones of the skull as pathways for sound to travel to a patient's inner ear. For people with conductive hearing loss, a BAHA or BCHD bypasses the external auditory canal and middle ear, and stimulates the still-functioning cochlea via an implanted metal post. For patients with unilateral hearing loss, a BAHA or BCHD uses the skull to conduct the sound from the deaf side to the side with the functioning cochlea. In some BAHA and BCHD systems, a titanium post or plate is surgically embedded into the skull with a small abutment extending through and exposed outside the patient's skin. A BAHA or BCHD sound processor attaches to the abutment and transmits sound vibrations through the external abutment to the implant. The implant vibrates the skull and inner ear, which stimulates the nerve fibers of the inner ear, allowing hearing. A BAHA or BCHD device can also be connected to an FM system or iPod by means of attaching a miniaturized FM receiver or Bluetooth connection thereto.
BAHA devices are manufactured by COCHLEAR™ of Sydney, Australia, and OTICON™ of Smoerum, Denmark. SOPHONO™ of Boulder, Colo. manufactures Alpha 1 and Alpha 2 magnetic BCHDs, which attach by magnetic means behind a patients ear to the patient's skull by coupling to a magnetic or magnetized bone plate (or “magnetic implant”) implanted in the patient's skull beneath the skin.
Surgical procedures for implanting such posts or plates are relatively straightforward; and are well known to those skilled in the art. See, for example, “Alpha I (S) & Alpha I (M) Physician Manual—REV A S0300-00” published by Sophono, Inc, of Boulder, Colo. the entirety of which is hereby incorporated by reference herein.
In
As further shown in
In some embodiments, the microphone incorporated into hearing aid 10 is an 8010T microphone manufactured by SONION®, for which data sheet 3800-3016007, Version 1 dated December, 2007, filed on even date herewith in the accompanying IDS, is hereby incorporated by reference herein in its entirety. In the various embodiments of hearing aids claimed herein, other suitable types of microphones, including other types of capacitive microphones, may be employed.
In still further embodiments of hearing aids claimed herein, electromagnetic transducer 25 incorporated into hearing aid 10 is a VKH3391W transducer manufactured by BMH-Tech® of Austria, for which the data sheet filed on even date herewith in the accompanying IDS is hereby incorporated by reference herein in its entirety. Other types of suitable EM or other types of transducers may also be used.
Referring now to
Continuing to refer to
Referring now to
Similarly, gel or paste 12 may be employed in conjunction with a non-magnetic or other type of BCHD 10, as shown in
In some embodiments, baseplate or spacer 50 is operably connected to or forms a portion of BCHD 10, and the baseplate or spacer is operably attached to or forms a portion of transducer 25. Transducer 25, by way of non-limiting example, may be an electromagnetic (“EM”) transducer or a piezoelectric transducer. BCHD 10 may be a magnetic BCHD or a non-magnetic BCHD. BCHD 10 may be attached or secured to patient's skull 70 or head 71 with at least one of a strap, a headstrap 13, a band, a head band, a clip, a hair clip, and/or an adhesive. Baseplate or spacer 50 may also be incorporated into a strap, a headstrap 13, a band, a head band, a clip, a hair clip, and/or a substrate comprising an adhesive. BCHD 10 may be attached to such a strap, a headstrap 13, a band, a head band, a clip, a hair clip, and/or a substrate by any number of suitable means, such as a snap or other suitable connecting or attachment means. Examples of headbands that may be adapted for use with gel or paste 12 include the PONTO soft band manufactured by Oticon and the BAHA softband manufactured by Cochlear.
In one embodiment, gel or paste 12 is a water-soluble gel. Gel 12 may comprise at least one of one or more of a cross-linked polyacrylate polymer, polyalkenyl ether, divinyl glycol propylene, glycol, glycerin, a carbomer, a carbopol, theolamine, water, demineralized water, distilled water, aloe vera, carrageenan, EDTA (Ethylenediaminetetraacetic acid), salt, vitamin E, a preservative, a thickening agent, and a neutralizer. Gel 12 may have a pH between about 5.5 and about 6.5, and may also be any one or more of substantially colorless, hypoallergenic, non-sterile, bacteriostatic, non-sensitizing to human skin, non-irritating to human skin, biocompatible, orally compatible, and ingestible. In some embodiments, the sound velocity of gel 12 ranges between about 1,450 meters/second and about 1,700 meters/second, and the viscosity of gel 12 ranges between about 10 Pascal-seconds and about 20 Pascal-seconds. In one embodiment, the viscosity of gel 12 is sufficient to remain attached to baseplate or spacer 50 when applied thereon in a layer having a thickness ranging between about 1 mm and about 2 mm. (Other thicknesses of gel 12 on bottom surface 52 of baseplate 50 are also contemplated.) Gel 12 may have an acoustic impedance substantially similar to soft human body tissue.
According to its various embodiments, gel or paste 12 fills voids or spaces that might otherwise be filled or created by air, hair, skin wrinkles or irregularities, and/or skin surfaces, which improves the efficiency of the transmission of sound signals from transducer 25 to the patient's skull 70. Using gel or paste 12, sound signals are transmitted largely or substantially through an acoustically efficient coupling medium (i.e., paste or gel 12) disposed between bottom surface 52 of baseplate or spacer 50 and patient's skin 75. Gel or paste 12 improves the transmission of sound energy, because sound is not effectively transmitted through air or hair. Aside from attenuation effects, air and hair can present severe acoustic impedance mismatches with respect to BCHD 10 and skin 75. Even an extremely thin air gap between bottom surface 52 of BCHD 10 or headstrap 13 and the patient's skin 75 can prevent efficient sound energy transmission to patient's skull 70.
Referring now to
Those skilled in the art will now understand that many different permutations, combinations and variations of gel or paste 12, and of BCHD 10, headstrap, clip or attachment means 13, baseplate or spacer 50, and other components of a BCHD system fall within the scope of the various embodiments. Those skilled in the art will now appreciate that many different combinations, permutations and configurations of gels, pastes, baseplates, spacers, headstraps, magnetic implants and BCHDs covers may be employed to arrive at suitable configurations of same. For example, the bottom surfaces 52 of baseplates or spacers 50 may be modified to retain or hold a gel or paste 12 therein by way of ridges or grooves provided therein, or an adhesive patch may be configured to hold a gel or paste thereon and secure a BCHD to a patient's skin or hair. Moreover, the above-described embodiments should be considered as examples, rather than as limiting the scopes thereof.
This application is a continuation-in-part of, and claims priority and other benefits from each of the following U.S. Patent Applications: (a) U.S. patent application Ser. No. 13/550,581 entitled “Systems, Devices, Components and Methods for Bone Conduction Hearing Aids” to Pergola et al. filed Jul. 16, 2012 (hereafter “the ‘581 patent application”); (b) U.S. patent application Ser. No 13/650,026 entitled “Magnetic Abutment Systems, Devices, Components and Methods for Bone Conduction Hearing Aids” to Kasic et al. filed on Oct. 11, 2012 (hereafter “the ‘650 patent application”); (c) U.S. patent application Ser. No. 13/650,057 entitled “Magnetic Spacer Systems, Devices, Components and Methods for Bone Conduction Hearing Aids” to Kasic et al. filed on Oct. 11, 2012 (hereafter “the ‘057 patent application”), now U.S. Pat. No. 9 022 917; (d) U.S. patent application Ser. No. 13/650,080 entitled “Abutment Attachment Systems, Mechanisms, Devices, Components and Methods for Bone Conduction Hearing Aids” to Kasic et al. filed on Oct. 11, 2012 (hereafter “the ‘080 patent application”), (e) U.S. patent application Ser. No. 13/1649,934 entitled “Adjustable Magnetic Systems, Devices, Components and Methods for Bone Conduction Hearing Aids” to Kasic et al. filed on Oct. 11, 2012 (hereafter “the ‘934 patent application”); (f) U.S. patent application Ser. No. 13/804,420 entitled “Adhesive Bone Conduction Hearing Device” to Kasic et al. filed on Mar. 13, 2013 (hereafter “the ‘420 patent application”), now U.S. Pat. No. 9,031,274; (g) U.S. patent application Ser. No. 13/793,218 entitled “Cover for Magnetic Implant in a Bone Conduction Hearing Device System, and Corresponding Devices, Components and Methods” to Kasic et al. filed on Mar. 11, 2013 (hereafter “the ‘218 patent application”); (h) U.S. patent application Ser. No. 14/288,181 entitled “Sound Acquisition and Analysis Systems, Devices and Components for Magnetic Hearing Aids” to Ruppersberg et al. (hereafter “the ‘181 patent application”), and (i) (j) U.S. patent application Ser. No. 14/288,142 entitled “Implantable Sound Transmission Device for Magnetic Hearing Aid, and Corresponding Systems, Devices and Components” to Ruppersberg et al. (hereafter “the ‘288 patent application”). This application also claims priority and other benefits from U.S. Provisional Patent Application Ser. No. 61/970,336 entitled “Systems, Devices, Components and Methods for Magnetic Bone Conduction Hearing Aids” to Ruppersberg et al. filed on Mar. 25, 2014. Each of the foregoing patent applications is hereby incorporated by reference herein, each in its respective entirety.
Number | Name | Date | Kind |
---|---|---|---|
4352960 | Dormer et al. | Oct 1982 | A |
4612915 | Hough et al. | Sep 1986 | A |
4726378 | Kaplan | Feb 1988 | A |
4736747 | Drake | Apr 1988 | A |
RE32947 | Dormer | Jun 1989 | E |
4918745 | Hutchinson | Apr 1990 | A |
4918757 | Janssen | Apr 1990 | A |
5558618 | Maniglia | Sep 1996 | A |
5906635 | Maniglia | May 1999 | A |
6039694 | Larson | Mar 2000 | A |
6246911 | Seligman | Jun 2001 | B1 |
6358281 | Berrang et al. | Mar 2002 | B1 |
6517476 | Bedoya et al. | Feb 2003 | B1 |
6537200 | Leysieffer | Mar 2003 | B2 |
6565503 | Leysieffer | May 2003 | B2 |
6631197 | Taenzer | Oct 2003 | B1 |
6648914 | Berrang et al. | Nov 2003 | B2 |
7186211 | Schneider et al. | Mar 2007 | B2 |
7386143 | Easter et al. | Jun 2008 | B2 |
7599508 | Lynch | Oct 2009 | B1 |
7856986 | Darley | Dec 2010 | B2 |
8107661 | Lynch | Jan 2012 | B1 |
8170253 | Lynch | May 2012 | B1 |
8255058 | Gibson et al. | Aug 2012 | B2 |
8270647 | Crawford et al. | Sep 2012 | B2 |
8315705 | Keuninckx | Nov 2012 | B2 |
8369959 | Meskens | Feb 2013 | B2 |
8406443 | Westerkull et al. | Mar 2013 | B2 |
8452412 | Ibrahim | May 2013 | B2 |
8515112 | Crawford et al. | Aug 2013 | B2 |
8538545 | Meskens | Sep 2013 | B2 |
8771204 | Telfort et al. | Jul 2014 | B2 |
8774930 | Ball | Jul 2014 | B2 |
8787608 | Van Himbeeck et al. | Jul 2014 | B2 |
8811643 | Crawford et al. | Aug 2014 | B2 |
8891795 | Andersson | Nov 2014 | B2 |
8897475 | Ball | Nov 2014 | B2 |
8897883 | Griffith | Nov 2014 | B2 |
8923968 | Meskens | Dec 2014 | B2 |
8934984 | Meskens et al. | Jan 2015 | B2 |
9020174 | Asnes | Apr 2015 | B2 |
20040202339 | O'Brien, Jr. | Oct 2004 | A1 |
20050038368 | Richter et al. | Feb 2005 | A1 |
20070053536 | Westerkull | Mar 2007 | A1 |
20070274551 | Tsai et al. | Nov 2007 | A1 |
20070286440 | Abolfathi et al. | Dec 2007 | A1 |
20090248155 | Parker | Oct 2009 | A1 |
20090299437 | Zimmerling | Dec 2009 | A1 |
20100145135 | Ball et al. | Jun 2010 | A1 |
20100179375 | Andersson et al. | Jul 2010 | A1 |
20110022120 | Ball et al. | Jan 2011 | A1 |
20110216927 | Ball | Sep 2011 | A1 |
20110257571 | Fritsch et al. | Oct 2011 | A1 |
20120029267 | Ball | Feb 2012 | A1 |
20120041515 | Meskens et al. | Feb 2012 | A1 |
20120078035 | Andersson et al. | Mar 2012 | A1 |
20120080039 | Siegert | Apr 2012 | A1 |
20120088957 | Adamson et al. | Apr 2012 | A1 |
20120238799 | Ball et al. | Sep 2012 | A1 |
20120294466 | Kristo et al. | Nov 2012 | A1 |
20120296155 | Ball | Nov 2012 | A1 |
20120302823 | Andersson | Nov 2012 | A1 |
20130018218 | Haller et al. | Jan 2013 | A1 |
20130046131 | Ball et al. | Feb 2013 | A1 |
20130089229 | Kristo et al. | Apr 2013 | A1 |
20130150657 | Leigh et al. | Jun 2013 | A1 |
20130245362 | Elofsson | Sep 2013 | A1 |
20130261377 | Adamson et al. | Oct 2013 | A1 |
20130281764 | Bjorn et al. | Oct 2013 | A1 |
20140064531 | Andersson et al. | Mar 2014 | A1 |
20140121447 | Kasic et al. | May 2014 | A1 |
20140121449 | Kasic et al. | May 2014 | A1 |
20140121450 | Kasic et al. | May 2014 | A1 |
20140121451 | Kasic et al. | May 2014 | A1 |
20140121452 | Kasic et al. | May 2014 | A1 |
20140140567 | LeBoeuf et al. | May 2014 | A1 |
20140153737 | Geschiere | Jun 2014 | A1 |
20140163692 | Van den Heuvel et al. | Jun 2014 | A1 |
20140193011 | Parker | Jul 2014 | A1 |
20140270293 | Ruppersberg et al. | Sep 2014 | A1 |
20140275731 | Andersson et al. | Sep 2014 | A1 |
20140275735 | Ruppersberg et al. | Sep 2014 | A1 |
20140275736 | Ruppersberg et al. | Sep 2014 | A1 |
20140336447 | Bjorn et al. | Nov 2014 | A1 |
20150016649 | Van Himbeeck et al. | Jan 2015 | A1 |
20150043766 | Westerkull | Feb 2015 | A1 |
20150063616 | Westerkull | Mar 2015 | A1 |
20150141740 | Miller | May 2015 | A1 |
20150146902 | Jinton et al. | May 2015 | A1 |
20150156594 | Bervoets | Jun 2015 | A1 |
Number | Date | Country |
---|---|---|
WO 2007024657 | Mar 2007 | WO |
2010105601 | Sep 2010 | WO |
2015020753 | Feb 2015 | WO |
2015034582 | Mar 2015 | WO |
Entry |
---|
Vengerova et al “Medical Gels for Ultrasonic Diagnosis, Therapy, and Electrocardiography.” p. 57-58. Jan.-Feb. 1994. |
Poltawski et al “Relative transmissivity of ultrasound coupling agents commonly used by therapists in the UK.” Ultrasound in Med. & Biol., vol. 33, No. 1, pp. 120-128, 2007. http://www.sciencedirect.com/science/article/pii/S0301562906017558. |
Mercola, “Alkaline Water: If You Fall for This ”Water Fad“ You Could Do Some Major Damage.” pp. 1-6. Sep. 11, 2010. http://articles.mercola.com/sites/articles/archive/2010/09/11/alkaline-water-interview.aspx. |
Mettler Electronics Corp. “Sonigel ultrasound transmission gel material safety data sheet.” Mar. 13, 2002. pp. 1-2. https://www.lakeland.edu/PDFs/MSDS/1392/Sonigel%20Ultrasound%20Gel%20(All%Brands).pdf. |
Number | Date | Country | |
---|---|---|---|
20150038775 A1 | Feb 2015 | US |
Number | Date | Country | |
---|---|---|---|
61970336 | Mar 2014 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 13550581 | Jul 2012 | US |
Child | 14516392 | US | |
Parent | 13650026 | Oct 2012 | US |
Child | 13550581 | US | |
Parent | 13650057 | Oct 2012 | US |
Child | 13650026 | US | |
Parent | 13650080 | Oct 2012 | US |
Child | 13650057 | US | |
Parent | 13649934 | Oct 2012 | US |
Child | 13650080 | US | |
Parent | 13256571 | Dec 2011 | US |
Child | 13649934 | US | |
Parent | 13804420 | Mar 2013 | US |
Child | 13256571 | US | |
Parent | 13793218 | Mar 2013 | US |
Child | 13804420 | US | |
Parent | 14288181 | May 2014 | US |
Child | 13793218 | US | |
Parent | 14288142 | May 2014 | US |
Child | 14288181 | US |