1. Field of the Invention
The present invention generally relates to treating sleep disorders, and more specifically relates to implant systems, devices and methods for treating patients suffering from obstructive sleep apnea.
2. Description of the Related Art
Obstructive sleep apnea (OSA) is caused by a blockage of the airway, which usually occurs when the soft tissue in the throat collapses and closes during sleep. According to the National Institutes of Health, OSA affects more than twelve million Americans. During each apnea event, the brain briefly arouses the sufferer in order to initiate the resumption of breathing. This type of sleep, however, is extremely fragmented and of poor quality. When left untreated, OSA may result in high blood pressure, cardiovascular disease, weight gain, impotency, headaches, memory problems, job impairment, and/or motor vehicle crashes. Despite the seriousness of OSA, a general lack of awareness among the public and healthcare professionals results in the vast majority of OSA sufferers remaining undiagnosed and untreated.
There have been a number of efforts directed to treating OSA. For example, devices for electrically stimulating the soft palate to treat snoring and obstructive sleep apnea are disclosed in U.S. Pat. Nos. 5,284,161 and 5,792,067. These devices have had mixed results because they require patient adherence to a regimen of use, subject the patient to discomfort during sleep, and result in repeated arousal of the patient.
Another treatment, commonly referred to as continuous positive airway pressure (CPAP), delivers air into a patient's airway through a specially designed nasal mask or pillow. The flow of air creates positive pressure when the patient inhales to keep the airway open. CPAP is considered by many to be an effective non-surgical treatment for the alleviation of snoring and obstructive sleep apnea, however, patients complain about discomfort caused by the mask and hoses, including bloating, nasal drying, and dry eyes. As a result, patient compliance for CPAP is only about 40%.
Surgical treatments have also been used to treat OSA. One such treatment is referred to as uvulopalatopharyngoplasty, which involves removing about 2 cm of the trailing edge of the soft palate to reduce the soft palate's ability to flutter between the tongue and the pharyngeal wall. Another procedure uses a surgical laser to create scar tissue on the surface of the soft palate, which reduces the flexibility of the soft palate for reducing snoring and/or closing of the air passage. Yet another procedure, commonly referred to as cautery-assisted palatal stiffening operation (CAPSO), is an office-based procedure performed under local anesthesia whereby a midline strip of soft palate mucosa is removed, and the wound is allowed to heal whereupon the flaccid palate is stiffened.
Surgical procedures such as those mentioned above continue to have problems. More specifically, the area of tissue that is surgically treated (i.e., removal of palatal tissue or scarring of palatal tissue) is often larger than is necessary to treat the patient's condition. In addition, the above-mentioned surgical procedures are often painful with extended, uncomfortable healing periods. For example, scar tissue on the soft palate may present a continuing irritant to the patient. Furthermore, the above procedures are not reversible in the event of adverse side effects.
Another surgical procedure for treating OSA uses several braided PET cylinders that are implanted in tissue to make the tissues of the tongue or uvula more rigid and less prone to deflection. The Pillar™ Palatal Implant System sold by Restore Medical of St. Paul, Minn. consists of cylindrical-shaped elements of braided polyester filaments that are implanted in the soft palate for reducing the incidence of airway obstructions in patients suffering from mild to moderate OSA. The Pillar device has been associated with a number of adverse side effects, including extrusion of the cylindrical-shaped elements, infection, and patient discomfort.
Another implant system, sold under the trademark REPOSE™ by InfluENT of Concord, N.H., uses a titanium bone screw that is inserted into the posterior aspect of the mandible at the floor of the mouth. A loop of suture is passed through the tongue base and attached to the mandibular bone screw. The Repose™ procedure achieves a suspension or hammock of the tongue base making it less likely for the base of the tongue to prolapse during sleep. Due to the high activity of the tongue during wakefulness, however, the suture component of this device may act as a “cheese cutter” to the tongue, causing device failure and requiring subsequent removal.
Another effort for treating OSA involves creating an auxiliary airway for bypassing the clogged portion of the main airway. In one embodiment of commonly assigned U.S. patent application Ser. No. 12/182,402, filed Jul. 30, 2008, the disclosure of which is hereby incorporated by reference herein, an auxiliary airway is formed by implanting an elongated conduit beneath a pharyngeal wall of the pharynx. The elongated conduit has a proximal end in communication with a first region of the pharynx, a distal end in communication with a second region of the pharynx, and an intermediate section extending beneath the pharyngeal wall for bypassing an oropharynx region of the pharynx.
Magnets have also been used for treating OSA. For example, in one embodiment of commonly assigned U.S. patent application Ser. No. 12/183,955, filed Jul. 31, 2008, the disclosure of which is hereby incorporated by reference herein, a magnetic implant includes a bone anchor, a first magnet coupled to the bone anchor, a tongue anchor, a second magnet coupled to the tongue anchor, and a support for aligning the first and second magnets so that a repelling force is generated between the magnets for urging the second magnet away from the first magnet and toward the bone anchor. The support maintains the first magnet at a fixed distance from the bone anchor, aligns the first magnet with the second magnet, and guides movement of the first and second magnets. The magnetic implant disclosed in one or more embodiments of the '955 application does not have a hard stop so as to avoid the “cheese-cutter” effect observed when using implants having a hard stop.
In one embodiment of commonly assigned U.S. patent application Ser. No. 12/261,102, filed Oct. 30, 2008, the disclosure of which is hereby incorporated by reference herein, an implant for treating obstructive sleep apnea includes an elongated element having a central area implantable in a tongue, the elongated element including a first arm extending from a first end of the central area and a second arm extending from a second end of the central area, with the first and second arms extending through the tongue and being anchored to the inframandibular musculature.
In spite of the above advances, there remains a need for additional systems, devices and methods for treating OSA through minimally invasive approaches that provide long term results, that encourage patient compliance, and that minimize patient discomfort.
In one embodiment, a system for treating obstructive sleep apnea includes an anchoring element including scar tissue disposed in an inframandibular region of a head, and a tongue implant having at least one arm extending therefrom, whereby the tongue implant is implantable in a tongue with the at least one arm being connectable with the anchoring element for coupling the tongue implant with the anchoring element and/or the scar tissue. In one embodiment, the anchoring element includes a first implant part disposed in the inframandibular region, whereby the scar tissue is formed at least partially around the first implant part. The tongue implant is coupled with the first implant part and/or the scar tissue through the at least one arm.
In one embodiment, the first implant part includes a flexible layer such as a flexible mesh or fabric. The first implant part may be biocompatible. In one embodiment, the first implant part includes resorbable material, non-resorbable material, biocompatible mesh, biocompatible fabric, woven mesh, knitted mesh, non-woven mesh, non-knitted mesh, a braided element, polypropylene, stainless steel, nitinol, silicone, polyethylene, polytetrafluoroethylene, resorbable synthetic polymers, polylactide, polyglycolide, polydioxanone, polycaprolactone, and co-polymers thereof.
In one embodiment, the tongue implant is elongated. The tongue implant is desirably flexible. In one embodiment, the tongue implant includes a buttress that defines a larger width region of the second implant part. After being implanted in a tongue, the buttress is preferably adapted to extend along an axis that traverses an anterior-posterior axis of the tongue. In one embodiment, the buttress section extends along an axis that is substantially perpendicular to the anterior-posterior axis of the tongue. The tongue implant may include a first arm extending from a first end of the buttress and a second arm extending from a second end of the buttress. The tongue implant may also include a first set of barbs projecting from the first arm and a second set of barbs projecting from the second arm. In one embodiment, the tongue implant may include a braided element and the first and second sets of barbs may extend through interstices of the braided element.
In one embodiment, a system for treating obstructive sleep apnea includes an anchoring element including scar tissue disposed in an inframandibular region of the head, and a tongue implant implantable in a tongue, whereby the tongue implant includes a buttress and at least one arm extending from the buttress. The at least one arm of the tongue implant is preferably attachable to the anchoring element for coupling the tongue implant with the anchoring element and/or the scar tissue. In one embodiment, the at least one arm includes a first arm extending from a first end of the buttress, the first arm having a first set of barbs projecting therefrom, and a second arm extending from a second end of the buttress, the second arm having a second set of barbs projecting therefrom. The barbs projecting from the first and second arms are preferably adapted to engage the scar tissue for coupling the tongue implant and the scar tissue together. In one embodiment, the spacing between the central buttress section of the tongue implant and the scar tissue is adjustable by pulling the first and second arms through the anchoring element and/or the scar tissue. As the arms are pulled through the anchoring element and/or the scar tissue, the barbs on the arms desirably collapse inwardly for allowing the arms to pass through the anchoring element and/or scar tissue. If the arms are pulled in the opposite direction, the barbs flex outwardly so as to engage the anchoring element and/or the scar tissue so as to limit or prevent movement of the arms in the opposite direction.
In one embodiment, the tongue implant may be made of materials including monofilaments, barbed monofilaments, braided elements, barbed braided elements, sutures and barbed sutures. The anchoring element may be made of biocompatible mesh, biocompatible fabric, woven mesh, knitted mesh, non-woven mesh, non-knitted mesh, a braided element, polypropylene, stainless steel, nitinol, silicone, polyethylene, polytetrafluoroethylene, resorbable synthetic polymers, polylactide, polyglycolide, polydioxanone, polycaprolactone, and co-polymers thereof.
In one embodiment, a method of treating obstructive sleep apnea includes forming scar tissue in an inframandibular region, implanting a tongue implant in a tongue, whereby the tongue implant has at least one arm extending therefrom, and advancing the at least one arm through the tongue and toward the inframandibular region for coupling the tongue implant with the scar tissue. In one embodiment, the scar tissue is formed by implanting a flexible layer in the inframandibular region, and forming the scar tissue at least partially on, in and/or around the flexible layer. In one embodiment, a sclerosing agent may be provided on, in and/or around the flexible layer for precipitating the formation of the scar tissue. The flexible layer may include absorbable and/or non-resorbable materials. The flexible layer may also be biocompatible and may include a mesh and/or a fabric. In one embodiment, the scar tissue may be formed using energy such as heat or laser energy. In one embodiment, the scar tissue may be formed by using energy and without requiring the implantation of a flexible layer.
In one embodiment, the tongue implant desirably includes a buttress, a first arm extending from the first end of the buttress, and a second arm extending from a second end of the buttress. The buttress desirably has a larger cross-sectional width than the cross-sectional width of the first and second arms. In one embodiment, the first arm has a first set of barbs projecting therefrom and a second arm has a second set of barbs projecting therefrom. The securing step may include engaging the scar tissue with the first and second sets of barbs on the respective first and second arms. In one embodiment, at least one of the arms is coupled with the scar tissue using sutures, clips, barbs, knots and/or adhesive.
In one embodiment, the first and second sets of barbs project away from one another in opposite directions. The tongue implant may include a braided element and the first and second barbs may extend through interstices of the braided element. In one embodiment, the tongue implant may include a braided buttress having a varying cross-sectional geometry.
In one embodiment, the spacing between the buttress section of the tongue implant and the anchoring element and/or the scar tissue in the inframandibular region may be adjusted by pulling the first and second barbed arms through the anchoring element and/or the scar tissue. As the barbed arms are pulled through the anchoring element and/or the scar tissue, the barbs preferably collapse inwardly to allow the arms to advance. If the arms are then pulled in the opposite direction, the barbs will flex outwardly to hold the arms in place so as to prevent the back of the tongue from sealing the airway to cause an OSA event. In one embodiment, the anchoring element may be a first implant part implantable in an inframandibular region and the tongue implant may be a second implant part implantable in a tongue or extending through a tongue.
As used herein, the term “inframandibular region” generally refers to the geniohyoid, mylohyoid, digastrics and pterygoid muscles, and may also include any tissue surrounding those muscle groups. Tension is preferably applied to the first and second arms for pulling the center area of the tongue implant toward the inframandibular musculature, which, in turn, moves a posterior surface of the tongue away from an opposing surface of a pharyngeal wall. In one embodiment, after the tension is applied, the first and second arms are desirably anchored to the anchoring element and/or the scar tissue in the inframandibular region for maintaining a space between the posterior surface of the tongue and the opposing surface of the pharyngeal wall.
In one embodiment, the braided arms may be modified to include barbed elements projecting therefrom so as to enhance anchoring of the arms in tissue upon implantation. In one embodiment, needles may be secured to the distal ends of the arms. A barbed element may be placed in the core of the braid or the braid may be formed around the barbed element. In one embodiment, the barbs preferably exit through the interstices of the braid so as to provide for enhanced tissue fixation to the hyoid bone, thyroid cartilage, scar tissue, tongue tissue, and/or other tissues such as muscles or fascia in the inframandibular region. In one embodiment, the barbs may serve as a means for attaching the implant device to additional components implanted in inframandibular musculature and/or soft tissue or cartilage located near the inframandibular musculature.
In one embodiment scar tissue is formed in the inframandibular region. The scar tissue may be formed by implanting a first implant part or an anchoring element in the inframandibular region. The scar tissue may also be formed using energy such as laser energy or heat, or by using a sclerosing agent. After the scar tissue is formed, a second implant part such as a tongue implant or a barbed device with a buttress in the center is implanted within a patient's mouth. The procedure may be performed on an outpatient basis or require a one night hospital stay. The arms coupled with the center buttress are preferably secured to a scar tissue and/or the first implant part disposed in inframandibular musculature and/or inframandibular tissue. The distance between the buttress and the scar tissue and/or first implant part may be adjusted by a surgeon at the time of implantation and will serve to prevent the tongue from sealing against the posterior wall of the pharynx. In one embodiment, by securing the arms to a soft anchor disposed in the inframandibular region, the “cheese cutter” effect that occurs when anchoring to a hard stop is avoided.
In one embodiment, the materials used for forming the tongue implant and/or the second implant part may include biocompatible materials such as non-resorbable and resorbable polymers. Suitable non-resorbable polymers may include silicone, polyethylene terephalate, polytetrafluoroethylene, polyurethane and polypropylene. Suitable resorbable polymers may include polylactide, polyglycolide copolymers, polycaprolactone, and collagen. In addition, materials such as nitinol, stainless steel, or resorbable alloys such as magnesium or iron alloys may be used to form the second implant part. In one embodiment, bladders of electrorheologic or magnetorheologic materials may also be placed within the center of the tongue implant and/or the second implant part. The stiffness of these materials may be altered by placing a magnet or electric field at a desired location such as in the soft palate or the posterior pharyngeal wall. The necessary magnetic or electric field may be applied by an external source and may be transmitted percutaneously to the materials by inductive coupling.
In one embodiment, an anchoring element is disposed in an inframandibular region and the anchoring element is coupled with a hyoid bone using one or more tethers or arms that are coupled with the hyoid bone. The length of the tether(s) or arm(s) may be adjusted for shifting the hyoid bone in an anterior direction. In one embodiment, the anchoring element includes a flexible layer and/or scar tissue.
These and other preferred embodiments of the present invention will be described in more detail below.
Referring to
As is well known to those skilled in the art, the soft palate and the tongue are both flexible structures. The soft palate SP provides a barrier between the nasal cavity N and the mouth M. In many instances, the soft palate SP is longer than necessary and extends a significant distance between the back of the tongue T and the posterior pharyngeal wall PPW.
Although the muscles relax throughout the body during sleep, most of the muscles of the respiratory system remain active. During inhalation, the diaphragm contracts and causes negative pressure to draw air A into the nasal cavity N and the mouth M. The air then flows past the pharynx PX, through the trachea TR and into the lungs. The negative pressure causes the tissue of the upper airway to deform slightly, which narrows the airway passage. In apneic patients, the soft palate SP, the tongue T, and/or the epiglottis EP collapse against the posterior pharyngeal wall PPW to block airflow into the trachea. As the airway narrows, airflow through the pharynx becomes turbulent which causes the soft palate SP to vibrate, generating a sound commonly known as snoring.
During sleep, humans typically experience brief obstructions of airflow and/or small decreases in the amount of airflow into the trachea and lungs. An obstruction of airflow for more than ten seconds is referred to as apnea. A decrease in airflow by more than fifty percent is referred to as hypopnea. The severity of sleep disorders is measured by the number of apneas and hypopneas that occur during every hour of sleep.
If apnea or hypopnea occurs more than five times per hour, most medical personnel diagnose the individual as having an upper airway resistance problem. Many of these patients often exhibit symptoms related to sleep disorders including sleepiness during the day, depression, and difficulty concentrating.
Individuals having ten or more episodes of apnea or hypopnea during every hour of sleep are officially classified as having obstructive sleep apnea syndrome. As the airway is obstructed, the individual makes repeated attempts to force inhalation. Many of these episodes are silent and are characterized by movements of the abdomen and chest wall as the individual strains to draw air into the lungs. Typically, episodes of apnea may last a minute or more. During this time, oxygen levels in the blood will decrease. Ultimately, the obstruction may be overcome by the individual generating a loud snore or awakening with a choking feeling.
Referring to
Referring to
Referring to
In one embodiment, the first implant part or anchoring element includes a mesh or fabric pad having a sclerosing agent provided thereon that is implanted in the inframandibular region. The mesh or fabric pad is left in place as scar tissue forms at least partially on, in and/or around the mesh or fabric pad. After a period of time, the newly formed scar tissue defines a mass of scar tissue such as a scar plane or scar plate that is disposed in the inframandibular region. The scar tissue preferably provides a soft anchor in the inframandibular region that may be coupled with an implant part disposed in a tongue, or coupled with a hyoid bone.
In one embodiment, the first implant part 22 has a size and shape that may be modified by a surgeon at the time of implantation. In one embodiment, a square of biocompatible mesh or fabric has dimensions of about four inches in length and about four inches in width. During surgery, the surgeon may cut the mesh or fabric into a size and shape reflecting the surgical needs of a patient, such as a rectangle, square, elliptical, or surgical shape.
Referring to
In one embodiment, the first and second arms 32, 34 projecting from the buttress may have barbs. The barbs desirably enhance attachment of the first and second arms of the second implant part to the first implant part and/or the scar plane formed about the first implant part. In one embodiment, the barbs on the respective first and second arms project in opposite directions.
In one or more preferred embodiments, the second implant part 24 may be formed from non-absorbable materials, absorbable materials, or a combination of non-absorbable and absorbable materials. The non-absorbable materials may include polymeric materials such as non-resorbable polymers, silicone, polyethylene terephalate, polytetrafluoroethylene, polyurethane and polypropylene, nitninol, stainless steel, and/or composite materials. Suitable resorbable polymers may include polylactide, polyglycolide copolymers, polycaprolactone, and/or collagen.
The first implant part 22 preferably serves as a “soft anchor” for the second implant part positioned in the tongue. In one embodiment, the spacing between the first implant part 22 and the second implant part 24 may be adjusted by pulling the first and second arms 32, 34 of the second implant part toward the first implant part so as to shorten the length of the arms between the two implant parts. The second implant part in the tongue is preferably advanced in an anterior and/or inferior direction so as to prevent the tongue from sealing against the back wall of the pharynx. The arms are preferably secured to the first implant part so as to maintain the tongue in the forward shifted position. The distal ends 26, 28 of the first and second arms 32, 34 are preferably secured to the first implant part 22 using methods and devices that are described in more detail herein.
Referring to
Referring to
Referring to
Referring to
Referring to
Referring to
In one embodiment, a surgeon may adjust the length of the respective first and second arms 32, 34 to shift the tongue T in an anterior and/or inferior direction so as to minimize the possibility of OSA episodes. In one embodiment, the first and second arms 32, 34 desirably include barbs that enable the first and second arms to be advanced through the interstices or pores of the first implant part 22 and/or the scar tissue in the inframandibular region. The barbs preferably enable the arms to move more easily in the direction designated D1, while providing more resistance to movement when the arms are pulled in the direction designated D2.
Referring to
Referring to
In one embodiment, one or more barbed elements are placed within the core of an elongated second implant part or tongue implant. In one preferred embodiment, the barbed elements are placed within the core of a braided tube and/or a braided tube may be formed about one or more barbed elements. In one embodiment, barbs preferably project through interstices of a braided element so as to enable enhanced tissue fixation. In one embodiment, needles are secured to the respective distal ends of the arms for advancing the arms through tissue, muscle, cartilage, or scar tissue. In one embodiment, the needles may be passed through the thyroid cartilage of a patient.
Referring to
Referring to
Referring to
Referring to
In one embodiment, the second implant part or tongue implant is implanted by advancing first and second arms 32, 32 of the second implant part 24 in lateral directions through the rear of the tongue T until the buttress section 30 of the second implant part 24 is centered in the tongue T. Advancement of the first and second arms is preferably facilitated by attaching tissue piercing elements such as needles to the free ends of both arms. In one embodiment, a small diameter trocar is desirably advanced through the musculature and into the floor of the mouth near the base of the tongue. A snare may be introduced through the lumen of each trocar to grab the distal ends 24, 26 of the respective first and second arms 30, 32. The first and second arms 30, 32 are pulled through the trocar and the trocar is removed. The free ends 26, 28 of the first and second arms 32, 34 are desirably pulled until the back of the tongue T is advanced just enough so that it does not form a seal against the back wall of the pharynx. The first and second arms 32, 34 may be attached to the first implant part 22 and/or the scar tissue to set the tongue in the new position. In embodiments where the first implant part is resorbable and in which the scar tissue is formed without using an implant, the first and second arms may also be attached to scar tissue formed in the inframandibular region. By securing the first implant part 22 in soft tissue such as the plane between the geniohyoid GH and the mylohyoid MH muscles, the “cheese-cutter” effect found in tongue implants having hard stops (e.g. a bone anchor) is avoided. The first and second arms 32, 34 of the second implant part 24 may be attached to the first implant part and/or scar tissue using sutures, glue, toggles, ultrasonic welding, interference with barbed elements, or direct knotting of the elongated second implant part 24 with the first implant part 22 or the scar tissue.
In one embodiment, the second implant part is fabricated as a tapered hollow braided shell through which the free ends of the first and second arms are passed. Once the tongue is set into the proper position, the large end of the flexible tube is passed over the free ends of the first and second arms. The small diameter end of the tube is pushed upward in the direction of the tongue in engagement with the barbed element. As the tube collapses and the small diameter end of the tube is pressed against the large diameter end, the collapsed mass of the tube serves as a load-bearing element against the surrounding soft tissue. Although this particular embodiment is not limited by any particular theory of operation, it is believed that the above-described structure provides an infinite number of anchoring locations or points for each distal end of the first and second arms of the first part of the implant.
In one embodiment, techniques well known to those skilled in the art are used for forming scar tissue in the inframandibular region. In one embodiment, laser energy may be used for forming the scar tissue. In another embodiment, heat energy may be used for forming the scar tissue. A sclerosing agent may also be used. An implant such as a tongue implant may be coupled with the scar tissue for shifting the position of the tongue for minimizing OSA events. A hyoid bone may also be coupled with the scar tissue using one or more elongated elements such as a tether.
The present invention provides a number of advantages over prior art methods and devices used for treating obstructive sleep apnea syndrome and hypopnea. First, the systems, devices and methods disclosed herein provide simple surgical procedures that are minimally invasive. Typically, the systems, devices and methods disclosed herein may be utilized during an outpatient procedure. In addition, the systems, devices and methods disclosed herein provide both immediate and long term results for treating obstructive sleep apnea syndrome and hypopnea. Moreover, the systems, devices and methods disclosed herein do not require a significant level of patient compliance.
In addition, the present invention does not anchor the posterior aspect of the tongue to a fixed, hard structure. Rather, the present invention uses a soft anchor in the inframandibular region. Thus, the present invention is significantly less likely to affect swallowing or speech, thereby providing a great improvement over prior art devices, systems and methods. The present invention also avoids the “cheese-cutter” effect found with prior art implants by teaching, inter alia, the use of a soft anchor in the inframandibular region and a buttress for the tongue implant. The present invention also preferably uses materials having long-term biocompatibility.
Although various embodiments disclosed herein relate to use in humans, it is contemplated that the present invention may be used in all mammals, and in all animals having air passages. Moreover, the systems, devices, and methods disclosed herein may incorporate any materials that are biocompatible, as well as any solutions or components that minimize rejection, enhance tissue ingrowth, enhance the formation of mucosal layers, and improve acceptance of the device by a body after the device has been implanted.
The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. As such, the scope of the present invention is to be limited only as set forth in the appended claims.
Number | Name | Date | Kind |
---|---|---|---|
3123077 | Alcamo | Mar 1964 | A |
3378010 | Codling et al. | Apr 1968 | A |
4069825 | Akiyama | Jan 1978 | A |
4290763 | Hurst | Sep 1981 | A |
4557264 | Hinsch | Dec 1985 | A |
4839215 | Starling et al. | Jun 1989 | A |
4881939 | Newman | Nov 1989 | A |
4950285 | Wilk | Aug 1990 | A |
5053047 | Yoon | Oct 1991 | A |
5123913 | Wilk et al. | Jun 1992 | A |
5192271 | Kalb et al. | Mar 1993 | A |
5192274 | Bierman | Mar 1993 | A |
5269783 | Sander | Dec 1993 | A |
5284161 | Karell | Feb 1994 | A |
5311028 | Glavish | May 1994 | A |
5393984 | Glavish | Feb 1995 | A |
5483077 | Glavish | Jan 1996 | A |
5484444 | Braunschweiler et al. | Jan 1996 | A |
5609559 | Weitzner | Mar 1997 | A |
5683417 | Cooper | Nov 1997 | A |
5704895 | Scott et al. | Jan 1998 | A |
5792067 | Karell | Aug 1998 | A |
5843077 | Edwards | Dec 1998 | A |
5931855 | Buncke | Aug 1999 | A |
6161541 | Woodson | Dec 2000 | A |
6190401 | Green et al. | Feb 2001 | B1 |
6241747 | Ruff | Jun 2001 | B1 |
6250307 | Conrad et al. | Jun 2001 | B1 |
6348156 | Vishnoi et al. | Feb 2002 | B1 |
6431174 | Knudson et al. | Aug 2002 | B1 |
6432437 | Hubbard | Aug 2002 | B1 |
6457472 | Schwartz et al. | Oct 2002 | B1 |
6513530 | Knudson et al. | Feb 2003 | B2 |
6523542 | Knudson et al. | Feb 2003 | B2 |
6578580 | Conrad et al. | Jun 2003 | B2 |
6589549 | Shih et al. | Jul 2003 | B2 |
6599310 | Leung et al. | Jul 2003 | B2 |
6627600 | Boutignon | Sep 2003 | B2 |
6634362 | Conrad et al. | Oct 2003 | B2 |
6638284 | Rousseau et al. | Oct 2003 | B1 |
6716251 | Asius et al. | Apr 2004 | B1 |
6742524 | Knudson et al. | Jun 2004 | B2 |
6755868 | Rousseau | Jun 2004 | B2 |
6800082 | Rousseau | Oct 2004 | B2 |
6899105 | Krueger et al. | May 2005 | B2 |
6955172 | Nelson et al. | Oct 2005 | B2 |
6981944 | Jamiolkowski et al. | Jan 2006 | B2 |
7017582 | Metzger et al. | Mar 2006 | B2 |
7056331 | Kaplan et al. | Jun 2006 | B2 |
7135189 | Knapp | Nov 2006 | B2 |
7146981 | Knudson et al. | Dec 2006 | B2 |
7166570 | Hunter et al. | Jan 2007 | B2 |
7213599 | Conrad et al. | May 2007 | B2 |
7237554 | Conrad et al. | Jul 2007 | B2 |
7261702 | Alexandre et al. | Aug 2007 | B1 |
7288075 | Parihar et al. | Oct 2007 | B2 |
7297102 | Smith et al. | Nov 2007 | B2 |
7322993 | Metzger et al. | Jan 2008 | B2 |
7337781 | Vassallo | Mar 2008 | B2 |
7360432 | Lehtonen | Apr 2008 | B2 |
7360542 | Nelson et al. | Apr 2008 | B2 |
7367340 | Nelson et al. | May 2008 | B2 |
7401611 | Conrad et al. | Jul 2008 | B2 |
7442389 | Quelle et al. | Oct 2008 | B2 |
7601164 | Wu | Oct 2009 | B2 |
7669603 | Knudson et al. | Mar 2010 | B2 |
7806908 | Ruff | Oct 2010 | B2 |
7850894 | Lindh, Sr. et al. | Dec 2010 | B2 |
7857829 | Kaplan et al. | Dec 2010 | B2 |
7888119 | Sugaya et al. | Feb 2011 | B2 |
8142422 | Makower et al. | Mar 2012 | B2 |
8307831 | Rousseau | Nov 2012 | B2 |
8413661 | Rousseau et al. | Apr 2013 | B2 |
20010037133 | Knudson et al. | Nov 2001 | A1 |
20020144685 | Ivanovich et al. | Oct 2002 | A1 |
20030004579 | Rousseau et al. | Jan 2003 | A1 |
20030034312 | Unger et al. | Feb 2003 | A1 |
20030149445 | Knudson et al. | Aug 2003 | A1 |
20030149447 | Morency et al. | Aug 2003 | A1 |
20030149488 | Metzger et al. | Aug 2003 | A1 |
20030176875 | Anderson et al. | Sep 2003 | A1 |
20040020492 | Dubrul et al. | Feb 2004 | A1 |
20040020498 | Knudson et al. | Feb 2004 | A1 |
20040028676 | Klein et al. | Feb 2004 | A1 |
20040044366 | Bonutti et al. | Mar 2004 | A1 |
20040102796 | Hill et al. | May 2004 | A1 |
20040139975 | Nelson et al. | Jul 2004 | A1 |
20040144395 | Evans et al. | Jul 2004 | A1 |
20040147811 | Diederich et al. | Jul 2004 | A1 |
20040149290 | Nelson et al. | Aug 2004 | A1 |
20040153127 | Gordon et al. | Aug 2004 | A1 |
20040231678 | Fierro | Nov 2004 | A1 |
20050038472 | Furst | Feb 2005 | A1 |
20050092334 | Conrad et al. | May 2005 | A1 |
20050115572 | Brooks et al. | Jun 2005 | A1 |
20050121039 | Brooks et al. | Jun 2005 | A1 |
20050159637 | Nelson et al. | Jul 2005 | A9 |
20050165352 | Henry et al. | Jul 2005 | A1 |
20050199248 | Pflueger et al. | Sep 2005 | A1 |
20050203576 | Sulamanidze | Sep 2005 | A1 |
20050251255 | Metzger et al. | Nov 2005 | A1 |
20050267321 | Shadduck | Dec 2005 | A1 |
20050267531 | Ruff et al. | Dec 2005 | A1 |
20050267532 | Wu | Dec 2005 | A1 |
20050267571 | Spence et al. | Dec 2005 | A1 |
20050279365 | Armijo et al. | Dec 2005 | A1 |
20060005843 | Nelson et al. | Jan 2006 | A9 |
20060079935 | Kolster | Apr 2006 | A1 |
20060083767 | Deusch et al. | Apr 2006 | A1 |
20060093644 | Quelle et al. | May 2006 | A1 |
20060150986 | Roue et al. | Jul 2006 | A1 |
20060185673 | Critzer et al. | Aug 2006 | A1 |
20060206197 | Morsi | Sep 2006 | A1 |
20060207608 | Hirotsuka et al. | Sep 2006 | A1 |
20060207612 | Jackson et al. | Sep 2006 | A1 |
20060228391 | Seyedin et al. | Oct 2006 | A1 |
20060241339 | Cook et al. | Oct 2006 | A1 |
20060266369 | Atkinson et al. | Nov 2006 | A1 |
20060289015 | Boucher et al. | Dec 2006 | A1 |
20070000497 | Boucher et al. | Jan 2007 | A1 |
20070005109 | Popadiuk et al. | Jan 2007 | A1 |
20070005110 | Collier et al. | Jan 2007 | A1 |
20070102004 | Nelson et al. | May 2007 | A1 |
20070102010 | Lemperle et al. | May 2007 | A1 |
20070110788 | Hissong et al. | May 2007 | A1 |
20070119463 | Nelson et al. | May 2007 | A1 |
20070123996 | Sugaya et al. | May 2007 | A1 |
20070144531 | Tomas et al. | Jun 2007 | A1 |
20070144534 | Mery et al. | Jun 2007 | A1 |
20070144535 | Hegde et al. | Jun 2007 | A1 |
20070190108 | Datta et al. | Aug 2007 | A1 |
20070204866 | Conrad et al. | Sep 2007 | A1 |
20070209665 | Gillis et al. | Sep 2007 | A1 |
20070227545 | Conrad et al. | Oct 2007 | A1 |
20070233276 | Conrad et al. | Oct 2007 | A1 |
20070246052 | Hegde et al. | Oct 2007 | A1 |
20070256693 | Paraschac et al. | Nov 2007 | A1 |
20070257395 | Lindh et al. | Nov 2007 | A1 |
20070261701 | Sanders | Nov 2007 | A1 |
20070267027 | Nelson et al. | Nov 2007 | A1 |
20070270631 | Nelson et al. | Nov 2007 | A1 |
20070272257 | Nelson et al. | Nov 2007 | A1 |
20070288057 | Kuhnel | Dec 2007 | A1 |
20070295338 | Loomas et al. | Dec 2007 | A1 |
20070295340 | Buscemi | Dec 2007 | A1 |
20080023012 | Dineen et al. | Jan 2008 | A1 |
20080035158 | Pflueger et al. | Feb 2008 | A1 |
20080035160 | Woodson et al. | Feb 2008 | A1 |
20080066764 | Paraschac et al. | Mar 2008 | A1 |
20080066765 | Paraschac et al. | Mar 2008 | A1 |
20080066767 | Paraschac et al. | Mar 2008 | A1 |
20080066769 | Dineen et al. | Mar 2008 | A1 |
20080078411 | Buscemi et al. | Apr 2008 | A1 |
20080146868 | Henri Robert et al. | Jun 2008 | A1 |
20080167614 | Tolkowsky et al. | Jul 2008 | A1 |
20080199824 | Hargadon | Aug 2008 | A1 |
20080208265 | Frazier et al. | Aug 2008 | A1 |
20080221684 | Nelson et al. | Sep 2008 | A1 |
20080312688 | Nawrocki et al. | Dec 2008 | A1 |
20090025734 | Doelling et al. | Jan 2009 | A1 |
20090078411 | Kenison et al. | Mar 2009 | A1 |
20090165803 | Bhat et al. | Jul 2009 | A1 |
20100023055 | Rousseau | Jan 2010 | A1 |
20100024830 | Rousseau | Feb 2010 | A1 |
20100030011 | Weadock | Feb 2010 | A1 |
20100037901 | Rousseau et al. | Feb 2010 | A1 |
20100080791 | Rousseau et al. | Apr 2010 | A1 |
20100106246 | Rousseau et al. | Apr 2010 | A1 |
20100108077 | Lindh | May 2010 | A1 |
20100132719 | Jacobs et al. | Jun 2010 | A1 |
20100137794 | Knudson et al. | Jun 2010 | A1 |
20100137905 | Weadock et al. | Jun 2010 | A1 |
20100158854 | Puisais | Jun 2010 | A1 |
20100163056 | Tschopp et al. | Jul 2010 | A1 |
20100211184 | Rousseau et al. | Aug 2010 | A1 |
20100234794 | Weadock et al. | Sep 2010 | A1 |
20100234946 | Rousseau | Sep 2010 | A1 |
20100256443 | Griguol | Oct 2010 | A1 |
20100294284 | Hohenhorst et al. | Nov 2010 | A1 |
20100319710 | Sharkawy et al. | Dec 2010 | A1 |
20110054522 | Lindh, Sr. et al. | Mar 2011 | A1 |
20110100376 | Rousseau | May 2011 | A1 |
20110100377 | Weadock et al. | May 2011 | A1 |
20110100378 | Rousseau | May 2011 | A1 |
20110144558 | Rousseau | Jun 2011 | A1 |
20110174315 | Zhang et al. | Jul 2011 | A1 |
20110178439 | Irwin et al. | Jul 2011 | A1 |
20110238111 | Frank | Sep 2011 | A1 |
20120123449 | Schaller et al. | May 2012 | A1 |
20120245629 | Gross et al. | Sep 2012 | A1 |
20130074849 | Rousseau et al. | Mar 2013 | A1 |
20130098371 | Rousseau et al. | Apr 2013 | A1 |
20130118505 | Rousseau et al. | May 2013 | A1 |
20130133669 | Rousseau | May 2013 | A1 |
20130150872 | Rousseau | Jun 2013 | A1 |
20130174857 | Rousseau et al. | Jul 2013 | A1 |
20130186412 | Weadock et al. | Jul 2013 | A1 |
20130319427 | Sung et al. | Dec 2013 | A1 |
Number | Date | Country |
---|---|---|
2465680 | Dec 2001 | CN |
201029957 | Mar 2008 | CN |
102198010 | Sep 2011 | CN |
10245076 | Apr 2004 | DE |
2145587 | Jan 2010 | EP |
2386252 | Nov 2011 | EP |
2517633 | Oct 2012 | EP |
2651113 | Mar 1991 | FR |
2001145646 | May 2001 | JP |
2003265621 | Sep 2003 | JP |
2005447 | Jan 1994 | RU |
2202313 | Apr 2003 | RU |
927236 | May 1982 | SU |
1697792 | Dec 1991 | SU |
WO 9713465 | Apr 1997 | WO |
9900058 | Jan 1999 | WO |
0066050 | Nov 2000 | WO |
0121107 | Mar 2001 | WO |
03096928 | Nov 2003 | WO |
WO 2004016196 | Feb 2004 | WO |
WO 2004016196 | Feb 2004 | WO |
2004020492 | Mar 2004 | WO |
2004021869 | Mar 2004 | WO |
2004021870 | Mar 2004 | WO |
2004060311 | Jul 2004 | WO |
2004084709 | Oct 2004 | WO |
2005046554 | May 2005 | WO |
2005051292 | Jun 2005 | WO |
2005082452 | Sep 2005 | WO |
2005122954 | Dec 2005 | WO |
WO 2006012188 | Feb 2006 | WO |
2006072571 | Jul 2006 | WO |
2006108145 | Oct 2006 | WO |
WO 2007056583 | May 2007 | WO |
2007075394 | Jul 2007 | WO |
2007132449 | Nov 2007 | WO |
2007134005 | Nov 2007 | WO |
2007146338 | Dec 2007 | WO |
2007149469 | Dec 2007 | WO |
2008118913 | Oct 2008 | WO |
2009023256 | Feb 2009 | WO |
2009036094 | Mar 2009 | WO |
WO 2010019376 | Feb 2010 | WO |
WO 2010019376 | Feb 2010 | WO |
WO 2010035303 | Apr 2010 | WO |
2010065341 | Jun 2010 | WO |
WO 2012004758 | Jan 2012 | WO |
2012041205 | Apr 2012 | WO |
2012064902 | May 2012 | WO |
2012170468 | Dec 2012 | WO |
Entry |
---|
Shamsuzzman, et al., “Obstructive Sleep Apnea; Implications for Cardiac and Vascular Disease”, JAMA, vol. 290: (14); pp. 1906-1914. |
Schwartz, et al., “Effects of electrical stimulation to the soft palate on snoring and obstructive sleep apnea”, J. Prosthetic Denistry, pp. 273-281 (1986). |
Wiltfang, et al., “First results on daytime submandibular elxtrostimulation of suprahyoidal muscles to prevent night-time hypopharyngeal collapse in obstructive sleep apnea syndrome”, International Journal of Oral & Maxillofacial Surgery, pp. 21-25 (1999). |
Harries, et al., “The Surgical treatment of snoring”, Journal of Laryngology and Otology, pp. 1105-1106 (1996). |
Huang, et al., “Biomechanics of snoring”, Endeavour, vol. 19 (3): pp. 96-100 (1995). |
Schwab, et al., “Upper airway and soft tissue changes induced by CPAP in normal subjects”, Am. J. Respit. Crit. Care Med., vol. 154, No. 4, Oct. 1996, 1106-1116. |
The Advance System, Aspire Medical, Inc., www.aspiremedical.com, 3 pp. (2008). |
Pang, Kenny et al., “Tongue Suspension Suture in Obstructive Sleep Apnea,” Operative Techniques in Otolaryngology, vol. 17, No. 4, Dec. 2006, pp. 252-256. |
Repose Genioglossus Advancement, Influent Medical, www.influ.ent.com, 1 page. (2008). |
The Pillar Procedure, Restore Medical, Inc., www.restoremedical.com, 2 pp. (2008). |
Cole, et al., “Snoring: A review and a Reassessment”, Journal of Otolaryngology, pp. 303-306 (1995). |
Teles et al., “Use of Palatal Lift Prosthesis on Patient Submitted to Maxillectomy: A Case Report”, Applied Cancer Res. 2005, vol. 25(3), pp. 151-154. |
Vicente et al., “Tongue-Base Suspension in Conjunction with Uvulopapatopharyngoplasty for Treatement of Severe Obstructive Sleep Apnea: Long-term Follow-Up Results”, The Laryngoscope, vol. 115(7), pp. 1223-1227 (2006). |
Wassmuth et al., “Cautery-assisted palatal stiffening operation for the treatment of obstructive sleep apnea syndrome”, Otolaryngology—Head and Neck Surgery, vol. 123(1), pp. 55-60 (Jul. 2000). |
Notification of Transmittal of the International Search Report and the Written Opinion of the International Search Authority or the Declaration mailed on Feb. 3, 2010; PCT/US2009/051921; International Filing Date: Jul. 28, 2009. |
Notification of Transmittal of the International Search Report and the Written Opinion of the International Search Authority or the Declaration mailed on May 25, 2010; PCT/US2010/023152; International Filing Date: Apr. 2, 2010. |
International Search Report dated Nov. 4, 2009 for International Patent Application No. PCT/US2009/052126. |
International Search Report dated Dec. 21, 2009 for International Patent Application No. PCT/US2009/057661. |
International Search Report dated Dec. 22, 2009 for International Patent Application No. PCT/US2009/061223. |
International Search Report dated May 25, 2010 for International Patent Application No. PCT/US2010/025778. |
Schleef et al., “Cytokine Activation of Vascular Endothelium, Effects on Tissue-Type 1 Plasminogen Activator Inhibitor” the J. of Biological Chem., vol. 263, No. 12, pp. 5797-5803 (1988). |
International Search Report dated Jan. 14, 2011 for International Patent Application No. PCT/US2010/052628. |
International Search Report dated Jan. 20, 2011 for International Patent Application No. PCT/US2010/052644. |
International Search Report dated Jan. 24, 2011 for International Patent Application No. PCT/US2010/052649. |
International Search Report dated Feb. 28, 2011 for International Patent Application No. PCT/US2010/059673. |
International Search Report dated Jan. 21, 2010 for International Patent Application No. PCT/US2009/052110. |
International Search Report dated Dec. 29, 2009 for International Patent Application No. PCT/US2009/061455. |
Database: WPI Week 198312, Thomson Scientific, London, GB; AN 1983-D9513K XP 002693421. |
Medtronic AlRvance System for Obstructive Sleep Apnea. http://www.medtronic.com/for-healthcare-professionals/products-therapies/ear-nose-throat/sleep-disordered-breathing-products/airvance-system-for-obstructive-sleep-apnea/index.htm. |
U.S. Appl. No. 13/307,482, filed Nov. 30, 2011. |
International Search Report dated Apr. 29, 2010 for International Patent Application No. PCT/US2009/065293. |
U.S. Appl. No. 13/486,293, filed Jun. 1, 2012. |
Database WPI Week 198312, Thomson Scientific, London, GB; AN 1983-D9513K XP002693421, -& SU 927 236 A1 (Petrozazodsk Univ) May 15, 1982 abstract (see figures 7 & 8). |
International Search Report dated May 25, 2010 for International Patent Application No. PCT/US2010/023152. |
International Search Report dated Apr. 9, 2013 for International Patent Application No. PCT/US2012/061569. |
International Search Report dated Apr. 2, 2013 for International Patent Application No. PCT/US2012/067708. |
Written Opinion dated Nov. 27, 2012 for International Patent Application No. PCT/US2012/056577. |
U.S. Appl. No. 61/203,758, filed Dec. 29, 2008, p. 8 & p. 6/8. |
Number | Date | Country | |
---|---|---|---|
20100132719 A1 | Jun 2010 | US |