WO2007062120A2 - Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps - Google Patents

Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps Download PDF

Info

Publication number
WO2007062120A2
WO2007062120A2 PCT/US2006/045203 US2006045203W WO2007062120A2 WO 2007062120 A2 WO2007062120 A2 WO 2007062120A2 US 2006045203 W US2006045203 W US 2006045203W WO 2007062120 A2 WO2007062120 A2 WO 2007062120A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
magnetic
tissue
support structure
implant device
Prior art date
Application number
PCT/US2006/045203
Other languages
English (en)
Other versions
WO2007062120A3 (fr
Inventor
Ryan P. Boucher
Joe Paraschac
Eric N. Doelling
Edward M. Gillis
David H. Cole
Original Assignee
Apneon, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Apneon, Inc. filed Critical Apneon, Inc.
Priority to EP06838273A priority Critical patent/EP1957017A4/fr
Priority to JP2008542440A priority patent/JP2009517131A/ja
Priority to CA002630742A priority patent/CA2630742A1/fr
Priority to AU2006318477A priority patent/AU2006318477A1/en
Publication of WO2007062120A2 publication Critical patent/WO2007062120A2/fr
Publication of WO2007062120A3 publication Critical patent/WO2007062120A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/002—Magnetotherapy in combination with another treatment

Definitions

  • the invention is directed to devices, systems, and methods for improved stabilization of magnetic force devices used in and/or on a body.
  • the improved stabilization may be realized both during placement and at an implanted position.
  • sleep apnea is a breathing disorder characterized by brief interruptions (10 seconds or more) of breathing during sleep. Sleep apnea is a common but serious, potentially life-threatening condition, affecting as many as 18 million Americans.
  • Central sleep apnea which is relatively rare, occurs when the brain fails to send the appropriate signal to the breathing muscles to initiate respirations, e.g., as a result of brain stem injury or damage.
  • Mechanical ventilation is the only treatment available to ensure continued breathing.
  • Obstructive sleep apnea is far more common. Normally, the muscles of the upper part of the throat keep the airway open to permit air flow into the lungs . When the muscles of the soft palate at the base of the tongue and the uvula (the small fleshy tissue hanging from the center of the back of the throat) relax and sag, the relaxed tissues may vibrate as air flows past the tissues during breathing, resulting in snoring. Snoring affects about half of men and 25 percent of women - most of whom are age 50 or older.
  • the airway becomes blocked, making breathing labored and noisy, or even stopping it altogether.
  • the number of involuntary breathing pauses or "apneic events" may be as high as 20 to 30 or more per hour. These breathing pauses are almost always accompanied by snoring between apnea episodes, although not everyone who snores has the condition. Sleep apnea can also be characterized by choking sensations.
  • the medical community has become aware of the increased incidence of heart attacks, hypertension and strokes in people with moderate or severe obstructive sleep apnea. It is estimated that up to 50 percent of sleep apnea patients have high blood pressure.
  • the sleeping person Upon an apneic event, the sleeping person is unable to continue normal respiratory function and the level of oxygen saturation in the blood is reduced. The brain will sense the condition and cause the sleeper to struggle and gasp for air. Breathing will then resume, often followed by continued apneic events. There are potentially damaging effects to the heart and blood vessels due to abrupt compensatory swings in blood pressure. Upon each event, the sleeping person will be partially aroused from sleep, resulting in a greatly reduced quality of sleep and associated daytime fatigue. Although some apneic events are normal in all persons and mammals, the frequency of blockages will determine the seriousness of the disease and opportunity for health damage. When the incidence of blockage is frequent, corrective action should be taken. II. Sleep and the Anatomy of the Upper Airway
  • the upper airway consists of a conduit that begins at the nasal valve, situated in the tip of the nose, and extends to the larynx. Although all tissue along this conduit is dynamic and responsive to the respiratory cycle, only the pharynx (the portion that starts behind the nasal cavity and ends in its connections to the supraglottic larynx is totally collapsible.
  • the cross sectional area of the upper airway varies with the phases of the respiratory cycle .
  • phase I the airway begins to dilate and then to remain relatively constant through the remainder of inspiration (Phase II) .
  • the airway begins to enlarge, reaching maximum diameter and then diminishing is size so that at the end of expiration (Phase IV) , it is at its narrowest, corresponding to the time when the upper airway dilator muscles are least active, and positive intraluminal pressure is lowest.
  • the upper airway therefore, has the greatest potential for collapse and closure at end- expiration, [ref : Schwab RJ, Goldberg AN.
  • Upper airway assessment radiographic and other imaging techniques. Otolaryngol Clin North Am 1998 ; 31 : 931-968]
  • OSA obstructive sleep apnea
  • SDB obstructive sleep-disordered breathing
  • CPAP which in essence acts as an airway splint for the respiratory cycle, is highly successful, it has some very significant shortcomings. It can be cumbersome to wear and travel with, difficult to accept on a social level, and not tolerated by many (for reasons such as claustrophobia, facial and nasal mask pressure sores, airway irritation) . These factors have lead to a relatively poor long-term compliance rate.
  • An alternative method would "splint" the airway during sleep that would give the benefits afforded by CPAP without some of its shortcomings would therefore be advantageous.
  • magnetic energy is used either attractively (opposite poles of two or more magnets facing one another, resulting in attractive forces) or repulsively (like poles of two or more magnets facing one another, resulting in forces which repel one another) .
  • Magnets implanted in the tongue interact either by attractive or repulsive forces with other magnets implanted in various organs of the upper airway system or external to the body within a neck collar.
  • the invention provides devices, and methods to improve implant tolerance generally, prevent implant migration, and stabilize a magnetic implant in tissue, e.g., the tongue, oropharynx, and pharyngeal wall.
  • the invention is particularly useful to prevent sleep disordered diseases such as Obstructive Sleep Apnea (OSA) and hypopnea (a partial obstruction of the airway during sleep) .
  • OSA Obstructive Sleep Apnea
  • hypopnea a partial obstruction of the airway during sleep
  • One aspect of the invention provides an implant device comprising at least two ferromagnetic components carried by a support structure in a spaced apart relationship.
  • the implant device includes at least one opening formed in the support structure between the ferromagnetic components .
  • the openings can provide stabilization after implantation, e.g., by providing flexibility, and/or tissue in-growth, or placement of external fixation elements, such as a suture, or a staple, or glue.
  • the support structure comprises a net-like array of openings.
  • the opening occupies a geometric center of the support structure .
  • the support structure is either generally U-shaped or O-shaped.
  • Another aspect of the invention provides an implant device comprising a ferromagnetic component carried on a a support structure.
  • at least one protrusion extends from the support structure.
  • the protrusion is sized and configured for engaging tissue to stabilize the support structure.
  • the protrusion can comprise, e.g., a barb, or a hook.
  • the implant device includes means for selectively withdrawing and extending the protrusion relative to the support structure.
  • Another aspect of the invention provides an implant device comprising a ferromagnetic component carried by a support structure.
  • the support structure includes a first side having a textured surface sized and configured for contact with tissue and a second side having a generally smooth surface. Contact between the textured first side and tissue within an airway stabilizes the implant, while the generally smooth surface, which faces the airway, minimizes interference with normal functions such as swallowing or speech.
  • an implant device comprising a ferromagnetic component carried on a support structure.
  • the implant is shaped to prevent motion, migration and extrusion while implanted in tissue.
  • the support structure can be sized and configured, e.g., with rounded corners, and/or irregular outer edges forming alternating wide and narrow areas, and/or regions of different thickness.
  • an implant device includes multiple magnetic arrays, and means for preventing attraction between the arrays to facilitate placement of the device in or on a tissue region.
  • a system is provided that comprises a magnetic implant device, and a pocket surgically created in tissue.
  • the pocket is sized and configured with an irregularly shape such that, when the magnetic implant is placed in the pocket, intact tissue around the implant prevents motion of the magnetic implant.
  • Another aspect of the invention provides a system comprising first, second, and third magnetic structures, each having a north magnetic pole.
  • the first and second magnetic structures are sized and configured for placement in or on a first tissue region in a spaced apart relationship.
  • the magnetic north poles or the first and second magnetic structures are mutually oriented toward a second tissue region.
  • the third magnetic structure is sized and configured for placement in or on the second tissue region.
  • the magnetic north pole of the third magnetic structure is oriented toward the first tissue region between the first and second magnetic structures.
  • the offset between the third magnetic structure and the first and second magnetic structures lends stability to the repelling interaction among the magnets in the system.
  • Another aspect of the invention provides a system for implanting a magnetic implant comprising side-by-side arrays of magnets that can flip or fold upon itself to form a folded-up structure.
  • the system comprises first means for separating the folded-up structure and positioning the magnetic implant in tissue, and second means for holding the magnetic implant in place while the first means separates the folded-up structure.
  • Another aspect of the invention provides a method for stabilizing a magnetic implant comprising side-by- side first and second magnetic sections.
  • the method threads a placement suture through two adjacent inner holes in the first magnetic section and ties the placement suture to form a loop .
  • the method folds the implant so that the first section overlaps the second section and places the implant while folded through the incision into a pocket formed in wall tissue.
  • the method positions a first instrument to hold the second section against fascia while placing a second instrument through the suture loop.
  • the method pulls the ends of the placement suture to apply force to separate the first and second sections, while using the second instrument to guide the first section into a side-by-side relationship with the second section.
  • the method places anchoring sutures at the four corners of the separated magnetic implant and then cuts the loop to remove the placement suture .
  • Another aspect of the invention provides methods for inserting a various shaped implants in soft tissue.
  • One method implants a U-shaped implant.
  • the method cuts two incisions in the soft tissue, and cuts a U- shaped pocket in the soft tissue.
  • the method uses a tool to push suture through one incision into the U-shaped pocket, until one end of the suture comes out through the other incision.
  • the method ties one end of the suture to the U-shaped implant.
  • the method uses a tool to push from one end of the implant, while pulling the suture at the other end of the implant, to fit the U-shaped implant into the specified pocket. The method closes the two incisions .
  • Another method implants an L-shaped implant.
  • the method cuts an incision in the soft tissue and cuts an L- shaped pocket in the soft tissue.
  • the method uses a tool to push the L-shaped implant into the L-shaped pocket and closes the incision.
  • Another method implants an O-shaped implant.
  • the method cuts an incision into the soft tissue and cuts an O-shaped pocket into the tissue.
  • the method inserts an 0- shaped implant with an open link into the pocket.
  • the method closes the open link of the O-shaped implant in the pocket and closes the incision.
  • implant devices, systems, and methodologies that embody technical features of the invention are well suited for placement in structures of the airway, such as the tongue, soft palate/uvula, and pharyngeal wall.
  • Fig. 1 is an anatomic view of a magnetic force system that includes a first magnetic component implanted in the back of the tongue and a second magnetic component implanted in a posterior region of the pharyngeal wall, the first and second magnetic components having the same polarity to magnetically interact by the generation of a repelling force between them, which prevents the tongue from moving in a posterior direction and closing or restricting the pharyngeal conduit or airway.
  • Fig. 2 is an anatomic view of a magnetic force system that includes a magnetic (or ferrous) array implanted near the posterior surface of the tongue and an external magnet that is mounted in a form fitting collar below the mandible and located forward, near the anterior surface of the chin, the magnetic or ferrous array and the external magnet being of opposite polarities to magnetically attract the implanted magnets forward, pulling the tongue in an anterior direction and opening the airway.
  • a magnetic (or ferrous) array implanted near the posterior surface of the tongue and an external magnet that is mounted in a form fitting collar below the mandible and located forward, near the anterior surface of the chin, the magnetic or ferrous array and the external magnet being of opposite polarities to magnetically attract the implanted magnets forward, pulling the tongue in an anterior direction and opening the airway.
  • Figs . 3 to 6 are alternative views of a magnetic force system of the type shown in Fig. 2.
  • Fig. 7A diagrammaticalIy shows an array of three repelling magnets oriented in a relatively stable repelling position, due to the creation of a magnetic force field saddle shown in Fig. 7B.
  • Figs. 8A, 8B, and 8C show various implantable magnetic arrays desirably shaped to provide both stability after implantation, as well as the healing rate post-operatively.
  • Figs. 9A, 9B, and 9C show representative embodiments of magnetic implants having at least one side with variegations to provide a tissue gripping surface, thereby providing stability after implantation.
  • Figs. 1OA, 1OB, 1OC, and 1OD show various types of magnetic implants with hooks, barbs, or a combination of the two, or equivalent components, to prevent migration and folding of the magnetic implant upon itself.
  • Figs. HA(I) to 11A(4) ; HB(I) to 11B(5); and HC(I) to HC (4) show various representative alternative embodiments of stabilized magnetic implant structures especially adapted for implantation in a posterior pharyngeal wall .
  • Figs. 12 and 13 show various types of magnetic implants that include apertures through which external fixation means, e.g., suture or staples, can be passed to attach the implant to surrounding tissue.
  • external fixation means e.g., suture or staples
  • Figs . 14A and 14B show an implant of the type shown in Fig. 8A, which includes a network of holes that can be filled with a growth-stimulating medium to encourage the in-growth of tissue to stabilize the implant.
  • Fig. 15 shows an implant of the type shown in Fig. 8A, which includes a network of holes filled a tissue adhesive or glue to give immediate post-op tissue stability.
  • Figs. 16 to 18 show various types of magnetic net array implants, including magnets or ferrous discs linked together by a net-like webbing with flanges which provide large areas in which the opposing surfaces of the surgically produced pocket may be closed (sutured or otherwise) for fast rejoining and healing of the tissue.
  • Figs. 19 to 22 show surgically formed pockets into which magnetic net array implants of the type show in Figs. 16 to 18 can be implanted for use.
  • Fig. 23 shows a surgically formed pocket that, with respect to the lateral and longitudinal dimensions of a given implant is laterally-tight but longitudinally-loose to accommodate anterior-posterior movement of the implant, but restrict lateral movement of the implant.
  • Fig. 24 shows a U-shaped implant placed in a tissue pocket of the same shape (e.g., in a tongue), the implant shape being keyed to prevent migration and limit relative tissue-to-implant motion.
  • Figs. 25A to D illustrate a way of inserting a U- shaped implant as shown in Fig. 24 in the tongue.
  • Fig. 26A shows an 0-shaped implant placed in a tissue pocket of the same shape (e.g., in a tongue), the implant shape being keyed to prevent migration and limit relative tissue-to-implant motion.
  • Figs. 26B and 26C show an 0-shaped implant of the type shown in Fig. 26A where magnets are positioned on only one side, the side without magnets acts as a rudder to distribute the force of the tongue and to stabilize the implant .
  • Figs. 27A to 27D illustrate a way of inserting an 0- shaped implant, as shown in Figs. 26A or 26B, in a tongue .
  • Figs. 28 and 29 show magnetic implants having a structure that prevents folding during implantation.
  • Figs. 3OA to 3OC show a magnetic implant which includes flexible hinges between arrays of magnetic discs, which allow the arrays to pivot into a serpentine shape (see Fig. 30C) , but prevent the arrays from folding upon themselves .
  • Fig. 31 shows a magnetic implant (shown prior to implantation) having magnetic arrays that are prone to folding or flipping upon itself in response to magnetic interaction.
  • Figs. 32A to 32D show tools and related methodology for controlling the separation of the magnetic arrays of the magnetic implant shown in Fig. 31, to prevent folding or flipping during implantation.
  • Fig. 33 shows a magnetic implant having preferential flexibility allowing the implant to remain in position because it closely mimics the movements of the surrounding anatomy.
  • Figs. 34A and 34B a magnetic implant having a support brace to help stabilize the implant.
  • Fig. 35 shows an alternative, circular design for the magnetic posterior pharyngeal wall implant.
  • Fig. 36 shows a magnetic implant having preferential flexibility that takes into account the shape and movement of the tongue .
  • Description of the Preferred Embodiments This Specification discloses various magnetic-based devices, systems, and methods for improved stabilization of magnetic forces both during implantation and at an implanted position.
  • the various aspects of the invention have application in procedures requiring the restriction of tissue collapse in and/or around the body, such as a passageway within the body.
  • the devices, systems, and methods that embody features of the invention are also adaptable for use with devices, systems, and methods that are not restricted to tissue based applications.
  • FIG. 1 shows, in an anatomic view, an illustrative magnetic force system 10.
  • the magnetic force system 10 resists the collapse of tissue in a targeted passageway, such as a pharyngeal structure and the individual anatomic components within the pharyngeal conduit during sleep. As generally shown in Fig.
  • the magnetic force system includes a first magnetic component 12 implanted in the back of the tongue and a second magnetic component 14 implanted in a posterior region of the pharyngeal wall.
  • the first and second magnetic components 12 and 14 have the same polarity. They magnetically interact by the generation of a repelling force between them.
  • the magnetic repelling force prevents the tongue from moving in a posterior direction and closing or restricting the pharyngeal conduit or airway.
  • the magnetic force system 10 can be differently configured and arranged, both anatomically and with respect to the position and polarity of the magnets.
  • Fig. 2 shows a cross section of a human head showing the nasal and oral cavities, tongue, oropharynx, chin and neck.
  • a magnetic (or ferrous or ferromagnetic) array 16 is implanted near the posterior surface of the tongue.
  • An external magnet 18 is mounted in a form fitting collar 20 such that the magnet is positioned below the mandible and located forward, near the anterior surface of the chin.
  • a soft pad 22 provides comfort for the wearer, preventing the magnet 18 from pressing directly against the flesh of the chin.
  • An outer covering 24 encases the magnet and wraps around for the collar 20 to stabilize and anchor the magnet 18 in the desired location.
  • the collar 20 can include a closure means such as a buckle or Velcro ® strap for ease of use.
  • the strap may further be elastic to provide a degree of stretch in the collar 20 for head movement, etc.
  • the collar 20 may be comprised of a foam interior with a stretchable fabric covering for softness and breathability.
  • the magnet 18 has a polarity that is opposite the polarity of the magnetic or ferrous or ferromagnetic array 16.
  • the magnet 18 will attract the implanted magnets or ferrous or ferromagnetic array 16, pulling the tongue in an anterior direction and opening the airway. This will prevent closure and occlusion of the airway during sleep.
  • Fig. 3 shows an alternative embodiment of a neck collar 20 with the magnet 18 placed just under the chin.
  • Fig. 4 shows another alternative embodiment.
  • the magnetic or ferrous or ferromagnetic array 16 is implanted near the posterior surface of the tongue.
  • the external magnet 18 of opposite polarity is mounted in a form fitting collar 20 such that the magnet is positioned against the anterior surface of the chin. This arrangement will cause the direction of the attractive force on the implanted array 16 to be directly forward, as opposed to a more-downward direction as in Fig. 2.
  • Fig. 5 shows an alternative embodiment, in which the external magnet 18 is held in place by a form fitting appliance 26 and collar 20. Closure and adjustability can be provided by a buckle and strap arrangement or by a Velcro ® strap 32.
  • Fig. 6 shows yet another embodiment, in which a headgear 30 is provided consisting of flexible webbing straps. Side straps 32 extend downwardly to cup the magnet and chin cup 34 with the magnet 18 fixed within the chin cup 34.
  • This arrangement has the further advantage of preventing the mouth from falling open during sleep. Open mouth breathing is blamed by some in loud snoring, drying of the mouth and exacerbation of the tendency of the tongue to fall backward into the airway.
  • Magnetic forces field systems repeling and/or attracting
  • the targeted pharyngeal structures and individual anatomic components within this region can include the pharyngeal walls; the base of the tongue; the vallecula; the hyoid bone and its attachments; the soft palate with uvula; the palatine tonsils with associated pillar tissue; and the epiglottis.
  • the implanted ferromagnetic material and/or the source of magnetic force can each comprise a single or discrete source of magnetism having a given desired orientation.
  • a single permanent magnet comprising a body of a ferromagnetic material, can comprise a single source of magnetism having a given orientation.
  • a flexible or compliant array of magnets can also comprise individual sources of magnetism carried as a unit on a support carrier, or otherwise directly linked together, as will be described. II. Magnetic Stabilization.
  • An attracting force can also be generated between a ferrous alloy/ferromagnetic material and a magnet.
  • the force when properly directed, provides the benefit of the system 10 in its various embodiments, as described.
  • the magnetic force can also create difficulty in implanting or positioning the magnets at the targeted tissue region, and can also contribute to the unwanted movement (i.e., migration or extrusion) of the magnets in the tissue region after implantation or positioning. It is desirable to provide magnetic field systems that are stabilized, both during implantation or positioning and after implantation during use.
  • a repelling magnetic force system is inherently less stable than a counterpart attracting magnetic system.
  • the inherent instability can be mitigated, e.g., by the relative orientation of repelling magnets to provide a preferred repelling position.
  • Fig. 7A shows an array 300 of three repelling magnets 302a, 302b, and 302c in a relatively stable repelling position.
  • the array 300 orients two magnets 302a and 302b in a laterally spaced-apart relationship, with the magnetic north poles (N) in parallel side-by-side axial alignment.
  • a lateral space 304 separates the magnets 302a and 302b.
  • the array 300 places the third magnet 302c in an indirect facing relationship with the two magnets 302a and 302b. As shown in Fig. 7A, the magnetic north pole
  • the offset array 300 creates a repelling force saddle 306 (see Fig. 7B) in the magnetic force field, which serves to stabilize or give a preferred repelling position.
  • FIG. 8A shows an implant 36 comprising flexible or compliant array of magnets 38 arranged in a polymer matrix having an outer profile or shape that is representative of a shape that provides stability in tissue after implantation.
  • the magnetic implant 36 has an irregular outer edge 40, with alternating wide and narrow areas. The wide areas prevent motion of the implant as healing occurs around the margins.
  • the capsule that forms around the implant 36 after implantation will contract, grabbing the narrow areas.
  • Holes 43 may be provided to allow tissue in- growth. The rounded corners of the implant 36 allow for faster healing of the surrounding tissues.
  • Fig. 8B shows an alternate embodiment of a magnetic implant 56 having a profile that is also designed to discourage migration.
  • the implant's flowing curves permit a large area of the surrounding tissues to grow around and grip the implant thus providing a natural anchor.
  • This implant 56 is particularly well suited for implantation in the tongue, which has a naturally curved morphology that matches the profile of the implant 56.
  • the rounded corners 60 and beveled edges 62 further allow for faster healing of the surrounding tissues.
  • Fixation Fig. 8C shows a magnetic implant 36 of a type shown in Fig. 8A having a textured underside 42, or "bottom treads,” to grip tissue. Stabilization of the implant 36
  • any implant in general can also be achieved through attachment of implant parts to the underlying tissue using, e.g., sutures or staples or glue, as will be described in greater detail later.
  • the treads 42 will limit motion relative to the tissue to encourage rapid healing.
  • Fig. 9A shows a magnetic implant 48 having a posterior, tissue-facing, side that includes variegations 44 to provide a tissue gripping surface.
  • the opposite anterior side 46 of the implant 48 (which typically faces an airway) can also be variegated, but in Fig. 9A the anterior side 46 is shown to be smooth, to aid the epithelial tissue in gliding over the implant during dynamic movement of the surrounding tissue, e.g., during swallowing or speech.
  • the anterior side 46 is shown to be smooth, to aid the epithelial tissue in gliding over the implant during dynamic movement of the surrounding tissue, e.g., during swallowing or speech.
  • the implant 48 provides both stabilizing for the magnetic implant 48 (due to the presence of the variegations 44 on the posterior tissue- facing side) , as well as increasing tolerance in patients by avoiding interference with the process of swallowing (due to the relatively un-variegated anterior airway- facing side 46) .
  • Figs. 9B and 9C show further embodiments, which are particularly useful for soft tissue fixation in the posterior pharyngeal wall.
  • the posterior pharyngeal wall implants 36 each includes a caudal (inferior) -facing protrusion 47 and 49, shown in Figs. 9B and 9C, respectively.
  • the caudal-facing protrusions 47 and 49 allow the magnetic implants 36 to become stabilized in a therapeutically-effective caudal-to-cranial orientation
  • Treatment of sleep apnea may necessitate insertion of a wide, flat implant in order to generate an effective magnetic field and, at the same time, limit bulking the tissue and making the obstruction worse.
  • protrusions such as hooks and barbs are desirably provided to grab the top tissue and limit motion.
  • Figs. 1OA and 1OB show a representative embodiment of a generally flat implant 50 with hooks 52 that dig into tissue, e.g., in the tongue or oropharynx.
  • Figs. 1OC and 1OB show a representative embodiment of a generally flat implant 50 with barbs 52 that provide the same function.
  • the hooks, barbs, or a combination of the two, or equivalent components prevent migration and folding of the magnetic implant upon itself.
  • Figs. HA(I) to 11A(4) show a representative embodiment of an implant 54 having at least one tissue piercing barb or hook 61, which is especially adapted for implantation in a posterior pharyngeal wall.
  • Fig. HA(I) shows the implant 54 that includes at least one anchoring assembly 55. Either or both cranial (superior) and/or caudal (inferior) ends of the implant 54 may be straight, gently rounded or curved.
  • the anchoring assembly 55 comprises, at one end, a loop 57 sized and configured for accommodating passage of a tissue suture or staple. In use, the loop 57 is intended to project beyond the cranial edge of the implant 54 for this purpose.
  • the anchoring assembly 55 includes, at the opposite end, a sharp, tissue-piercing or anchoring barb or hook 61.
  • the barb 61 is intended to project beyond the caudal edge of the implant 54.
  • the barb or hook 61 can be manufactured, e.g., from resilient shape memory NiTi wire, resilient formed stainless steel 316L, or any other medical grade metal.
  • the barb or hook 61 can be resiliently straightened by the application of external pressure (as Fig. 11A(2) shows) , and will resiliently return toward its curved hook shape in the absence of applied pressure (as Fig. HA (1) shows) . In the illustrated embodiment (see Figs.
  • the anchoring assembly 55 is sized and configured to be passed, hook end 61 first, through a constricted cranial-caudal channel 63 formed in the implant 54.
  • the channel 63 can be formed, e.g., from NiTi tubing. In use, the channel 63 extends in a cranial- caudal direction, parallel to the longitudinal anatomic axis of the pharyngeal conduit.
  • the channel 63 may extend through holes formed through the individual magnets 65 carried by the implant 54. Alternatively, as shown in Fig. HA(1) , the channel 63 passes through the flexible polymer matrix material of the implant 54 itself.
  • the hooked end 61 When introduced into the cranial end of the channel 63 (see Fig. 11A(3) ) , the hooked end 61 will resiliently straighten within the confines of the channel 63. The hooked end 61 will resiliently return to its hook shape
  • the implant 54 can include more than one channel 63 to accommodate a plurality of anchoring assemblies 55, each with a suture loop 57 and a barbed end 61 for fixation of the implant 54 in tissue.
  • the implant device 54 can be placed within a pocket P, e.g., surgically created in tissue in the pharyngeal conduit wall.
  • An X-ray or any other suitable image is desirably taken to ensure that the position of the implant 54 within the tissue pocket P is correct.
  • the desired number of anchoring assemblies 55 is passed, hook end 61 first, through a channel 63, from cranial end toward the caudal end (see Fig. HA(3)) . Free of the channel 63, the end(s) 61 resiliently return(s) to the hook shape (see Fig.
  • the suture material S can be removed from the loop 57.
  • the hook 61 can be withdrawn from tissue and back into the caudal end of the channel 63 (as Fig. 11A(2) shows) .
  • the implant 54 can be completely removed from the pocket P, or it can be re-positioned and then re-affixed, according to the patient's needs.
  • Fig. HB(I) shows another representative embodiment of an implant 54 having at least one tissue piercing barb or hook 67, which is especially adapted for implantation in a posterior pharyngeal wall.
  • two hooks 67 are shown.
  • Each barb or hook 67 can be manufactured, e.g., from NiTi wire, stainless steel 316L, or any other medical grade metal.
  • each barb or hook 67 is permanently affixed to the implant 54, e.g., by coupling to one or two of the magnetic components.
  • the barb or hook 67 extends from the caudal end of the implant 54.
  • a removable protective cover 69 (e.g., made from u-shaped nitinol or any other biocompatible material) is desirably fitted over the barb or hook 67 prior to use (as Fig. HB(I) shows) and/or during implantation (as shown in Fig. 11B(2)).
  • an implant pocket P is surgically created in the pharyngeal conduit tissue.
  • the pocket P that is formed is desirably longer than the implant 54 itself, by a distance designated D in Fig. 11 (B) (2), e.g., by at least 3mm.
  • the implant 54 is placed into the pocket P, caudal end first, as Fig. HB (2) shows. An X-ray or any other suitable image is taken to ensure that the position of the implant 54 is correct. Once the correct position of the implant 54 in the tissue pocket is confirmed, the implant 54 is lowered by a distance less than D (e.g., by approximately 2mm) into the pocket P, and the protective cover 69 is removed (see Fig.
  • Each barb or hook 67 pierces pharyngeal wall tissue within the pocket P, to anchor the caudal portion of the implant 54 within the pocket P.
  • the cranial end of the implant 54 can then anchored by suture material S passed through the apertures in the cranial end of the implant 54 (as Fig. HB (3) shows) .
  • the implant pocket P is re-opened, again recreating a pocket P at least 3mm longer than the implant 54.
  • the sutures S at the cranial end of the implant 54 are cut and the implant 54 is lowered within the pocket P to release each barb or hook 67 from the surrounding tissue, so that the protective cover 69 can be fitted back over the barbs or hooks 67.
  • a special spatula tool 300 can be used to facilitate of the release of the barbs or hooks 67.
  • the spatula tool 300 has a distal end 302 that is generally the same width as the implant 54.
  • the distal end 302 includes a soft polymer material, sized and configured to engage the sharp ends of the barbs or hooks 67.
  • the spatula tool 300 is inserted behind the implant 54 to the implant device 54 to help free the barbs or hooks 67 from the tissue. Once the barbs or hooks 67 of the implant 54 are free of tissue, they will grab the soft polymer material of the distal end 302.
  • the spatula tool 300 and the attached implant 54 can now be readily removed from the pocket P as Fig. HB (5) shows. Once removed from the pocket P, the barbs or hooks 67 can be disengaged from the distal end 302, and the protective cover 69 can be fitted back over the barbs or hooks 67.
  • the implant 54 is again ready to be re-positioned into the pocket, if desired, in the manner previously described.
  • the anchoring systems described, with one or more barbs or hooks, allow posterior pharyngeal wall implants to stabilize in desired positions so as to maximize the therapeutic effects of the implant systems.
  • Figs. HC (1) and HC (2) show another representative embodiment of an implant 54 having at least one tissue piercing barb or hook 71, which is especially adapted for implantation in a posterior pharyngeal wall.
  • the implant 54 includes an anchoring assembly 73 comprising a U-shaped carrier 75, which carries at least one tissue piercing barb or hook 71.
  • the carrier 75 carries a plurality of barbs or hooks 71, As before described, each barb or hook 71 can be manufactured, e.g., from resilient shape memory NiTi wire, resilient formed stainless steel 316L, or any other medical grade metal.
  • the U-shaped carrier 75 slides within tracks 79 formed within the implant 54 between a first position (shown in Fig. HC(I)) and second position (shown in Fig. HC(2)). In the first position (Fig. HC(I)), the barbs or hooks 71 are retracted within the implant 54. In the second position (Fig. HC(2)), the barbs or hooks 71 extend through holes in the track 79 outward from the implant 54.
  • the implant 54 is placed within a surgically formed tissue pocket P (see Fig. 11C(3)) (e.g., formed in a posterior pharyngeal wall), with the carrier 75 in the first position, retracting the barbs or hooks 71. Once the desired position for the implant 54 is achieved, the carrier 75 is moved to the second position
  • One or more sutures S can be applied to the carrier 75 at the cranial end of the implant 54. Should repositioning or removal of the magnetic posterior pharyngeal wall implant 54 be necessary, the carrier 75 can be pulled up to the first position, retracting the barbs or hooks 71, so that the implant 54 re-positioned within or removed from the pocket P .
  • the U-shaped carrier 75 need not include side barbs or hooks 71, but comprise an elongated staple that slides within the tracks 79 and exits the caudal end of the implant 54 to engage tissue.
  • the carrier 75 can be pulled up to retract the staple at the caudal end, so that the implant 54 re-positioned within or removed from the pocket P.
  • one or more sutures can be applied to the carrier 75 at the cranial end of the implant 54.
  • Implants need to have features to reduce the stress on the implant, but still allow them to maintain the device shape .
  • Another way to limit stress on a given implant 62 is to include apertures 64 through which external fixation means, e.g., suture or staples, can be passed to attach the implant to surrounding tissue, as illustrated in Fig. 12. This attachment may be to tissue either on the cranial end or the caudal end of the implant. Additionally, if the thickness of the underlying tissue permits, barbs such as silicone extensions (as previously described) may be also incorporated in the implant 62. This design will limit the amount of force applied at the implant edges and prevent motions that can lead to extrusion.
  • FIG. 13 shows an implant 66 whose inner edge 68 contains holes 70 to allow the use of surgical thread or suture 72 to anchor the implant to tissue, e.g., into the pharyngeal wall. 5.
  • the implant 36 shown in Fig. 8A includes a network of holes or cutouts 43 that allow tissue in-growth.
  • the in-growth of surrounding tissue that the holes or cutouts 43 allow further stabilizes the implant.
  • the implant 36 shown in Fig. 8A can be used, e.g., as a tongue implant, with the predetermined cut-outs 43 strategically- positioned to promote tissue in-growth. Promoting tissue in-growth is beneficial in providing a lock-in position that further discourages implant migration.
  • the curved implant 56 shown in Fig. 8B also incorporates an opening 58 in the center of the implant 56 allow for tissue in-growth, further stabilizing the implant. As before stated, this embodiment is particularly well suited for implantation in the tongue. The implant's flowing curves permit a large area of the surrounding tissues to grow around and grip the implant thus providing a natural anchor.
  • Figs. 14A and 14B show an implant 36 of the type shown in Fig. 8A, in which the network of holes 43 is filled with a growth-stimulating medium 74, which bridges the gap between the upper and lower tissue layers, encouraging rapid healing.
  • Fig. 14B shows a close-up of the growth media 74 used in the implant .
  • the growth- stimulating substance 74 could be bio-absorbable, or act as a scaffold for cell growth. The tissue in-growth will help stabilize the implant.
  • Fig. 15 shows an implant 36 of the type shown in Fig. 8A, in which the network of holes 43 are filled a tissue adhesive 76 or glue (e.g. fibrin glue, cyanoacrylate) .
  • tissue adhesive 76 e.g. fibrin glue, cyanoacrylate
  • glue may be used by itself or in conjunction with growth stimulating media 74 (shown in Figs. 14A and 14B) to give immediate post-op tissue stability.
  • Fig. 16 is a plan view of a net array implant 98. Magnets or ferrous discs 100 are linked together by a net-like webbing with flanges 102 surrounding each of the magnets or ferrous shapes. Each disk 100 is linked to the adjacent disc by a cross web 104, providing protection and isolation from body fluids and tissue.
  • Openings 106 provide large areas in which the opposing surfaces of the surgically produced pocket may be closed (sutured or otherwise) for fast rejoining and healing of the tissue. Further, the narrow flanges surrounding the discs provide clearance for further approximation of the tissue faces. The periphery of the discs (see Fig. 17) is sloped 108 to allow the tissue to form closely around the discs and provide maximum surface tissue contact between the opposing faces of the tissue pocket in which the implant 98 will reside.
  • the material of which the net array web is produced will preferably be a polymer or compound providing a predictable flexural modulus to allow normal speech and swallowing without discomfort or otherwise affecting these functions.
  • Certain medical grades of silicone rubber, PTFE (polytetrafluoroethylene) Teflon ® and certain laminates using Gore Tex ® are suitable candidates for this application.
  • An additional and desirable characteristic of the material of which the array web is made will be providing a surface that supports attachment by the surrounding tissue (in-growth) . Expanded PTFE and Gore Tex ® are known to exhibit this characteristic.
  • Fig. 18 shows an alternative embodiment of a net array implant 98. In this embodiment, the flanges 110 are linked together around the outside of the array.
  • cross ties 112 diagonally join the discs 100, to provide further stabilization.
  • Many different configurations of the webbing may be employed to provide varying flexibility or stiffness. For instance, all cross webbing and peripheral links may follow a serpentine path instead of a straight line. This will allow the disks to move toward or away from one another when the muscular tongue tissue lengthens or shortens during speech, swallowing, etc.
  • the magnetic or ferrous shapes may be other than circular, such as (but not limited to) square, rectangular, oval, elliptical, etc.
  • the magnetic net array 98 provides a highly stable implanted magnetic or ferrous device, overcoming difficulties related to migration magnet flipping and inadequate forces needed to prevent occlusion of the airway during a sleep related obstructive breathing event. Furthermore, the magnetic net array will allow the healing of the surgical implantation site prior to the application of any attractive or repelling forces and promote speedy healing through close approximation of the wound surfaces.
  • the net array 98 can be implanted in a stable manner in various ways .
  • Fig. 19 shows a surgically produced pocket 114 with an opening 116 from the left posterior surface of the tongue.
  • a magnet or ferrous load net array 98 is positioned for placement into the open pocket.
  • Fig. 20 shows the net array 98 inserted and the opening 116 closed using sutures, staples, tissue adhesive or other accepted wound closure means 118. Further suturing 120 or other tissue securing means can be applied in the open areas of the net array 98 to provide tight approximation of the opposing internal surfaces of the pocket .
  • a template may be provided to the surgeon to aid in accurate placement of the sutures in the openings in the array 98.
  • Fig. 21 shows a surgically produced pocket 114 that is oriented vertically instead of the horizontal orientation described above.
  • the opening 116 of the pocket 114 is upward and the net array 98 is positioned into the pocket 114.
  • Fig. 22 shows a net array 98 implanted and the opening closed with suitable closure means 118 as described above. Further, additional sutures or other anchoring means 120 are placed in areas of openings in the net array 98. A template may be provided to the surgeon to aid in accurate placement of the sutures in the openings in the array 98. 9. Specially Dimensioned Surgical Pockets
  • a surgically formed pocket 96 may be formed that, with respect to the lateral and longitudinal dimensions of a given implant (for example, implant 36 shown in Fig. 8A) , is laterally-tight but longitudinally-loose .
  • Fig. 23 shows, for the purposes of illustration, the implant 36 to be of the type shown in Fig. 8A, but the pocket 96 can be sized to accommodate other types of implants.
  • the pocket dimensions accommodate anterior-posterior movement of the implant 36, but restrict lateral movement of the implant 36.
  • the dimensions of the pocket prevent implant migration, while allowing the implant 36 to move with the tissue, e.g. the tongue, during normal activities.
  • surgical pockets are contemplated for "keyed" shapes implants. Such embodiments include, but are not limited to, U-, 0- , and L-shaped surgical pockets . 10. Open Implants
  • Preceding embodiments stabilize various styles of implants by allowing and/or encouraging surrounding tissue to grow through a net-like structure of the magnetic implant's polymer matrix. Another way to stabilize implants is by leaving the tissue in the center of the implant substantially intact .
  • Fig. 24 shows a U-shaped implant 78 placed in a tissue pocket 82 of the same shape (e.g., in a tongue) .
  • Implant shape is keyed to prevent migration and limit relative tissue-to-implant motion.
  • Figs. 25A to 25D illustrate a way of inserting a U- shaped implant 78 in the tongue.
  • two incisions 80 are made in the tongue. The two incisions 80 are used to cut out a U-shaped implant pocket 82 in the tissue.
  • suture 84 is pushed through the U-shaped pocket 82. One end of the suture is then tied to the implant 78.
  • Fig. 25C using curved forceps at one end for pushing the implant and gently pulling the implant from the other end, the U- shaped implant 78 is fitted into the pocket 82. During this process, one leg of the U-shaped pocket becomes enlarged as the implant turns in the pocket.
  • the two incisions 80 are closed up with stitches 84. This method allows the implant to effectively stabilize in its specified location.
  • Fig. 26A shows an O-shaped implant 86 placed in a tissue pocket 88 of the same shape (e.g., in a tongue).
  • the O-shaped implant 86 leaves tissue 90 in the center of the implant 86 substantially intact. This implant shape is also keyed to prevent migration and limit relative tissue-to-implant motion.
  • Fig. 26B shows an 0-shaped implant 86 where magnets 87 are positioned on only one side.
  • the side 89 without magnets acts as a rudder to distribute the force of the tongue and to stabilize the implant.
  • the opening in center incorporates intact tongue raphe tissue to resist de-centering.
  • Fig. 26C shows a side view of the interaction between the one-sided O-shaped implant 86 of the type shown in Fig, 26B and a corresponding repelling pharyngeal wall implant 101.
  • Figs. 27A to 27D illustrate a way of inserting an 0- shaped implant 86, as described.
  • the O-shaped implant 86 may have magnets 87 on both sides, as for example the embodiment shown in Fig. 26A, or only on one side, as for example the embodiment shown in Fig. 26B. Both types of O-shaped implants would use the same insertion method.
  • an incision 92 is cut in the tongue and the O- shaped pocket 88 is created in the tissue.
  • the O-shaped implant 86 with open links Ll and L2, i.e., in an open configuration is inserted into the O-shaped pocket 88.
  • the open link L2 of the O-shaped implant 86 is inserted around a posterior corner of the O-shaped pocket 88, drawing the other open link Ll to the opposite posterior corner.
  • the links Ll and L2 adjoin (as Fig. 27C shows) , thus changing the implant 86 to a closed configuration.
  • the incision 92 is closed up with stitches 94. With this method as well, the implant is firmly stabilized in its specified location.
  • Arrays of side-by-side magnets can attract each other during implantation and (if not suitably stabilized) after implantation, causing the implant to fold or flip inward upon itself.
  • Such implant assemblies can be stabilized by providing more rigid cross-support structures between the arrays to prevent the motion of attracting the two arrays together.
  • Fig. 13 previously described, shows an implant 66 with stiff sections 122 between the two magnetic arrays 124 and 126. The stiff section 122 prevents migration of the two sections 124 and 126 of the implant toward one another via attraction during implantation.
  • Fig. 28 shows an alternative embodiment of a magnetic implant 128 having a structure that prevents folding during implantation.
  • the magnetic implant 128 consists of two main magnetic sections 130 and 132, flexibly joined together by two smaller rigid structures 134 and 136. The flexible juxtaposition of the two smaller rigid structures 134 and 136 provides four potential twisting points through which the implant 128 may flexibly twist, but the implant 128 will avoid folding.
  • Fig. 29 shows an alternative embodiment of a magnetic implant 138 which includes middle webbing 140 integrated between two magnetic sections 142 and 144 into the magnetic implant device to keep the implant 138 from folding upon itself during implantation.
  • the middle webbing 140 contains a rigid structure for increased rigidity during the insertion process .
  • Figs. 3OA to 3OC show an alternative embodiment of a magnetic implant 148 which includes flexible hinges 150 and 152 between two arrays 154 and 156 of magnetic discs 158.
  • Figs. 3OB and 3OC show the north (N) -south (S) polarity of the magnetic discs 158.
  • the flexible hinges 150 and 152 allow the arrays 154 and 156 to pivot into a serpentine shape (see Fig. 30C) , but prevent the arrays 154 and 156 from folding upon themselves.
  • Some of the implant assemblies described above are stiffened by the presence of rigid cross-support structures between the magnetic arrays to prevent the attracting forces between the arrays from flipping or folding the arrays upon themselves.
  • Figs. 31 and 32A to 32D show tools and related methodology for controlling the separation of the magnetic arrays 200 and 202 of a magnetic implant 190 (shown prior to implantation in Fig. 31) that is prone to folding or flipping upon itself in response to magnetic interaction.
  • suture 192 is threaded through one of the magnetic arrays 200 of the implant 190 and tied to form a loop 194.
  • the implant 190 is folded so that the magnetic arrays 200 and 202 overlap. Folded over, the implant 190 is placed through an incision into a tissue pocket (e.g., like the pockets shown in Figs. 19, 21, or 23).
  • a tissue pocket e.g., like the pockets shown in Figs. 19, 21, or 23.
  • a first nonmagnetic surgical instrument 196 holds the magnetic array 202 of the implant 190 against the tissue fascia.
  • a second non-magnetic surgical instrument 198 is placed through the suture loop 194.
  • the suture loop 194 is pulled as the first instrument 196 holds the magnetic array 202 against tissue, and as the second instrument 198 pulls the ends of the suture 192 up and slightly to the side to separate the magnetic array 200 from the magnetic array 202.
  • the second instrument 198 continues to guide the magnetic array 200 to separate the magnetic arrays 200 and 202 within the pocket.
  • FIG. 32D shows, with the magnetic arrays 200 and 202 separated, suitable anchoring sutures 206 are threaded through suture holes 204 provided in the arrays 200 and 202 to secure each magnetic array 200 and 202 to tissue within the pocket.
  • the placement suture 192 is then cut and removed.
  • the instruments 196 and 198 are withdrawn and the pocket closed.
  • the instruments 196 and 198 that can be used for separating magnetic arrays include: forceps, compass-like spreaders, forceps, tongue-blades and needle-holders . They are manufactured out of non-magnetic materials, e.g., titanium. C .
  • the pharyngeal wall is a dynamic structure that undergoes considerable movement on a daily basis.
  • a pharyngeal wall implant to be well tolerated, such an implant must be able to be stabilized effectively, while remaining flexible in a posterior-anterior direction.
  • Fig. 33 shows an implant 158 having spanning members 160 between the magnetic array sections 162, extending along the vertical (elongated) axis on both sides of the centerline.
  • the spanning members 160 each have a reduced thickness, compared to the thickness of the magnetic array sections 162.
  • the thinner cross section of the spanning members 160 facilitates flexibility in the anterior-posterior direction, while the thicker magnetic array sections 162 discourage flexibility in the medial- lateral direction. This preferential flexibility allows the implant to remain in position because it closely mimics the movements of the surrounding anatomy.
  • the implant 158 has other features described above to impart stability and comfort while implanted, e.g., holes for accommodating passage of sutures or fasteners for fixation, and rounded corner edges and beveled side edges 166 to promote faster healing.
  • Posterior pharyngeal wall implants present special challenges due to the difficulty associated with the attachment/suturing of the caudal end of the implants to the tissue in the posterior wall.
  • Rectangular posterior pharyngeal wall implants are often susceptible to misalignment with relation to the spine. A misalignment with respect to the spine will offset the magnetic interaction between the tongue/soft palate/uvula implant and the posterior pharyngeal wall implant. If the rectangular device is attached only on top part using sutures, then the magnetic force from the tongue base will swing laterally and misalign the back-wall plate.
  • Figs. 34A and 34B show a way to help stabilize the posterior pharyngeal wall implant 54 into a position that, while not hindering the natural movement of the posterior wall, provides enough stiffness to the posterior pharyngeal wall implant to prevent the pendulum-like motion.
  • the implant 54 allows for posterior-anterior motion for the normal functioning of the posterior pharyngeal wall, while preventing lateral motion that would cause the tissue pocket to tear or re-open.
  • the implant 54 includes a support brace 180 secured to the posterior (tissue facing) side of the implant 54.
  • the support brace 180 is thin and combines the shape of a cross and the shape of a trident.
  • the support brace 180 includes a vertical axis 181, with a hole 183 on each of the caudal and cranial ends for suturing the cranial and caudal ends of the implant 54.
  • the support brace 180 includes a horizontal component 185 with two handles 187 raised at an angle between 90° and 180° from each end. Each of the handles 187 contains a hole 189 for suturing the support brace 180 to the posterior pharyngeal wall tissue.
  • the posterior pharyngeal wall implant support is desirably made of a material that is elastic in its posterior-anterior movement while rigid with regard to lateral movement and twisting about the vertical axis of the support.
  • materials include titanium, biocompatible plastics, as well as other biocompatible materials.
  • Fig. 35 shows an alternative design for the magnetic posterior pharyngeal wall implant .
  • the posterior pharyngeal wall implant 184 is circular, with the attachment holes 186 placed in the center.
  • the circular design is sutured into place over the spine at the center of the circle.
  • the circular magnetic pharyngeal wall implant is attached at its center over the spine.
  • the circular shape favors perfect alignment without any additional anchoring or correction. If the circular shape is attached at the center, then it has a self-centered geometry, as seen in Fig. 35.
  • Implants for the Tongue Fig. 36 shows an implant 170 adapted for implantation in a tongue.
  • the implant 170 provides preferential flexibility that takes into account the shape and movement of the tongue.
  • the implant 170 includes flexible cross members 172 that extend along the long (longitudinal) axis that are thicker than (and thus less flexible than) the cross members 174 that extend along the short (transverse) axis.
  • the design of this implant 170 promotes longitudinal stiffening and discourages the implant from folding in on itself.
  • the thinner cross members 174 running across the narrower areas of the implant 170 allow for flexibility which closely mimics the movements of the tongue during normal oral activities.
  • This embodiment of the invention has the advantage of combining implant stability with increased tolerance in the patient.
  • the implant 170 has other features described above to impart stability and comfort while implanted.
  • the implant 170 also includes integrated fixation tabs 176 that extend outward from the magnetic discs 178 to engage adjacent tissue and provide enhanced fixation and stabilization.
  • the implant also includes holes 180 for tissue in-growth or the placement of a tissue in-growth promoting material or bio-adhesive, as previously described.

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne des systèmes et des procédés pour prévenir une migration d’implant magnétique et une extrusion dans les voies aériennes supérieures. Les systèmes et les procédés concernent tous les deux des techniques chirurgicales ainsi que des caractéristiques structurelles pour traiter le problème de la migration d’implant magnétique.
PCT/US2006/045203 2005-11-23 2006-11-22 Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps WO2007062120A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP06838273A EP1957017A4 (fr) 2005-11-23 2006-11-22 Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps
JP2008542440A JP2009517131A (ja) 2005-11-23 2006-11-22 体内または身体上で使用される磁力デバイスの安定または固定のためのデバイス、システムおよび方法
CA002630742A CA2630742A1 (fr) 2005-11-23 2006-11-22 Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps
AU2006318477A AU2006318477A1 (en) 2005-11-23 2006-11-22 Devices, systems, and methods for stabilization or fixation of magnetic force devices used in or on a body

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US73951905P 2005-11-23 2005-11-23
US60/739,519 2005-11-23

Publications (2)

Publication Number Publication Date
WO2007062120A2 true WO2007062120A2 (fr) 2007-05-31
WO2007062120A3 WO2007062120A3 (fr) 2007-11-22

Family

ID=38067899

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/045203 WO2007062120A2 (fr) 2005-11-23 2006-11-22 Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps

Country Status (5)

Country Link
EP (1) EP1957017A4 (fr)
JP (1) JP2009517131A (fr)
AU (1) AU2006318477A1 (fr)
CA (1) CA2630742A1 (fr)
WO (1) WO2007062120A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2081523A2 (fr) * 2006-11-03 2009-07-29 Koninklijke Philips Electronics N.V. Dispositifs, systèmes et procédés utilisant des systèmes de force magnétique affectant la langue ou les muscles hyoïdes dans les voies respiratoires supérieures
CN105793249A (zh) * 2013-11-27 2016-07-20 武田药品工业株式会社 用于治疗或预防精神病学和神经病学疾患的哌啶衍生物
CN107789890A (zh) * 2017-10-31 2018-03-13 无锡德沃精工设备有限公司 一种磨削液过滤设备

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005051292A2 (fr) 2003-11-20 2005-06-09 Apneon, Inc. Dispositifs, systemes et procedes permettant de fixer des tissus dans certaines zones corporelles, telles que le conduit pharyngien
US20050159637A9 (en) 2002-09-06 2005-07-21 Apneon, Inc. Devices, systems, and methods to fixate tissue within the regions of body, such as the pharyngeal conduit

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2349952T3 (es) * 2002-08-29 2011-01-13 St. Jude Medical, Cardiology Division, Inc. Dispositivos implantables para controlar la circunferencia interna de un orificio o lumen anatómico.
WO2006019521A2 (fr) * 2004-07-15 2006-02-23 Micardia Corporation Dispositif a memoire de forme et procedes de remodelage de l'anatomie du coeur

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050159637A9 (en) 2002-09-06 2005-07-21 Apneon, Inc. Devices, systems, and methods to fixate tissue within the regions of body, such as the pharyngeal conduit
WO2005051292A2 (fr) 2003-11-20 2005-06-09 Apneon, Inc. Dispositifs, systemes et procedes permettant de fixer des tissus dans certaines zones corporelles, telles que le conduit pharyngien

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1957017A4

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2081523A2 (fr) * 2006-11-03 2009-07-29 Koninklijke Philips Electronics N.V. Dispositifs, systèmes et procédés utilisant des systèmes de force magnétique affectant la langue ou les muscles hyoïdes dans les voies respiratoires supérieures
EP2081523A4 (fr) * 2006-11-03 2014-01-08 Koninkl Philips Nv Dispositifs, systèmes et procédés utilisant des systèmes de force magnétique affectant la langue ou les muscles hyoïdes dans les voies respiratoires supérieures
CN105793249A (zh) * 2013-11-27 2016-07-20 武田药品工业株式会社 用于治疗或预防精神病学和神经病学疾患的哌啶衍生物
CN105793249B (zh) * 2013-11-27 2019-09-24 武田药品工业株式会社 用于治疗或预防精神病学和神经病学疾患的哌啶衍生物
US10562882B2 (en) 2013-11-27 2020-02-18 Takeda Pharmaceutical Company Limited Piperidine derivatives for use in the treatment or prevention of psychiatric and neurological conditions
CN107789890A (zh) * 2017-10-31 2018-03-13 无锡德沃精工设备有限公司 一种磨削液过滤设备

Also Published As

Publication number Publication date
AU2006318477A1 (en) 2007-05-31
CA2630742A1 (fr) 2007-05-31
EP1957017A2 (fr) 2008-08-20
JP2009517131A (ja) 2009-04-30
WO2007062120A3 (fr) 2007-11-22
EP1957017A4 (fr) 2012-01-04

Similar Documents

Publication Publication Date Title
US8001971B2 (en) Devices, systems, and methods for stabilization or fixation of magnetic force devices used in or on a body
US8074654B2 (en) Implantable devices, systems, and methods for maintaining desired orientations in targeted tissue regions
EP2157940B1 (fr) Dispositifs implantables, systèmes et procédés pour le maintien d'orientations souhaitées dans des régions tissulaires ciblées
US8707959B2 (en) Implantable devices, systems, and methods for maintaining desired orientations in targeted tissue regions
US7845356B2 (en) Implantable devices, systems, and methods for maintaining desired orientations in targeted tissue regions
US7481224B2 (en) Magnetic force device, systems, and methods for resisting tissue collapse within the pharyngeal conduit
US7500484B2 (en) Magnetic force devices, systems, and methods for resisting tissue collapse within the pharyngeal conduit
EP2363102B1 (fr) Dispositifs à force magnétique, systèmes et procédés permettant de résister à l'affaissement d'un tissu dans le conduit pharyngien
US8807137B2 (en) Self-anchoring magnetic force implant devices, systems, and methods
AU2009322708B2 (en) Implant systems and methods for treating obstructive sleep apnea
US20080066764A1 (en) Implantable devices, systems, and methods for maintaining desired orientations in targeted tissue regions
US20120312307A1 (en) Implantable devices, systems, and methods for maintaining desired orientations in targeted tissue regions
AU2003270368A1 (en) Magnetic force devices, systems, and methods for resisting tissue collapse within the pharyngal conduit
EP1957017A2 (fr) Dispositifs, systemes et procedes pour la stabilisation ou la fixation de dispositifs a force magnetique utilises dans ou sur un corps
JP5371971B2 (ja) 目標組織領域における所望方向性を維持するための移植可能型デバイス、システム及び方法
WO2007079055A2 (fr) Dispositifs, systemes et procedes d'implant a force magnetique et auto-ancrage

Legal Events

Date Code Title Description
DPE2 Request for preliminary examination filed before expiration of 19th month from priority date (pct application filed from 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 2008542440

Country of ref document: JP

Ref document number: 2630742

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2006318477

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2006838273

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2006318477

Country of ref document: AU

Date of ref document: 20061122

Kind code of ref document: A