Abstract: A tracheal tube attachment for a tracheal device is disclosed. The tracheal tube attachment fits over an end of a tracheal device to directly connect the tracheal device to an oxygen source. The tracheal tube attachment may include a central chamber having radial openings which may be partially or fully covered by a collar rotatably fitted around the central chamber. The collar and radial openings may be used to control the amount of oxygen received through the oxygen tube, as well as exhaling carbon dioxide to ambient.

Abstract: A voice prosthesis insertion device includes an elongated body having an aperture therein extending axially along the elongated body. The elongated body includes a ring member at one end that is supported by a pair of straps. The elongated body has at least one region that is increasing in cross section. The elongated body further having a collapsible portion defined by a pair of openings in the elongated body. A rod is disposed in the aperture of the elongated body and including a peg adapted to be inserted into an aperture of a tether of a voice prosthesis device. The collapsible portion of the elongated body is flexible to allow the collapsible portion to be longitudinally collapsed to expose the peg of the rod for easy engagement with the strap of the voice prosthesis and the collapsible portion is extendable from the collapsed position to extend over the peg.

Abstract: Object: Provided is a dysphonia treatment tool in which a front surface piece is bent. Resolution means: A dysphonia treatment tool includes a plurality of clamping sections (1, 1) each including a front surface piece (1a) disposed from a cut end surface of thyroid cartilage incised to a front surface, and a rear surface piece (1b) disposed on a rear surface of the thyroid cartilage, and being fitted respectively to cut ends of the thyroid cartilage that are opposite each other, and a bridging section (2) linking the plurality of clamping sections (1, 1) to each other. The front surface piece (1a) is bent in an intermediation section between a base end and a distal end of the front surface piece (1a).

Abstract: The present invention provides a jig for forming a dysphonia treatment tool, the jig being capable of bending a front piece in a position not through a hole. A jig 20C for forming a dysphonia treatment tool X by deformation, the dysphonia treatment tool X including: a plurality of clamping sections each having a front piece 1a disposed on a front surface of incised thyroid cartilage and a rear piece disposed on a rear surface of the thyroid cartilage, the clamping sections configured to be fit to respective cut ends of the thyroid cartilage facing each other; and a bridging section linking the clamping sections to each other, the front piece having a hole 3 formed therein, the forming jig includes a clip section 22 having a pair of maintaining sections 21a, 21b configured to sandwich the front piece 1a from both surfaces to cover at least a portion of the hole 3.

Abstract: The present invention provides a computer-aided conversion test system and method for generating intelligible speech. The test system includes an acoustic test module with a nasal-genio-oropharyngeal tract, a transmitting module generates a detecting signal, a first receiving module, a second receiving module, and a central processing module with a plurality of first phonetically oral cavity shape spectra. By adjusting the transmitting module, the first receiving module, or the second receiving module, a second phonetically oral cavity shape spectrum is correctly compared and identified by a central computing unit as one of the corresponding first phonetically oral cavity shape spectra. After testing, training and adjusting through the test method, the detecting signal transmitted by the transmitting module is analyzed and identified by the central processing module to increase its interpretation accuracy and shorten the time of machine learning.

Abstract: A speech assistance device includes: an adaptor defining a first end and a second end, a first end of the adaptor configured to cover and seal directly or indirectly against a tracheal stoma defined in a neck of a user, the adaptor comprising a compressible material; a reed module connected to the adaptor, the reed module including a reed configured to produce sound using air expelled by the user from the stoma; and a tube coupled to the reed module, the tube configured to be inserted into a mouth of the user.

Abstract: To solve the problem of making available a speech valve for persons who have undergone a laryngectomy or tracheotomy, which speech valve in particular has a long useful life, a speech valve is proposed having a housing with a proximal opening and at least one filter at least partially received in the housing, and with a piston-like valve element, wherein the filter at least partially surrounds the valve element, wherein the valve element is movable on a valve seat, arranged on the proximal opening, in order to produce a closure position and can be returned with a spring action to an open position of the speech valve, and wherein the valve element has a lower end which faces towards the proximal opening and which is assigned to the valve seat in the open position and, with the valve seat, forms a gap through which an air stream can be guided.

Abstract: In a therapeutic device for respiratory passages (1) for the treatment of respiratory problems, comprising at least one pipe section (3) which has at least one passage duct (4) through which air (5) can be inhaled or exhaled and at least one elastic hose (8) with its first free end (9) arranged on one free end on one of the pipe sections (3) and which can vibrate during inhalation or exhalation in one flow direction (6) because of the throughflow, the hose (8) should be able to be exchanged in a straightforward and uncomplicated procedure even by people with restricted finger mobility or manual dexterity.

Abstract: The invention disclosed is an improved audio output module for use with an artificial voice generation device, having a housing separated into a sound system chamber, an interface chamber, and a power source chamber. The interface and power source chambers may be combined. The sound chamber is isolated from external air by the housing, the cover plate, and a separating wall, which separates it from other chambers of the module. Volumetric parameters based on speaker characteristics and design requirements can thus be implemented independent from the choice of interface type. The module is configurable to be mounted to an external structure or to a speech generating system. It may likewise be detachable from a quick release cradle and receive wireless audio signals from the speech generating system.

Abstract: A representative method includes: providing a tracheostomy valve assembly having a housing and a diaphragm, the housing defining an interior airflow path, the housing having an exterior surface, a distal opening extending from the exterior surface to the interior flow path and a proximal opening, the distal opening and the proximal opening communicating with the interior airflow path, the diaphragm being disposed within the housing along the interior airflow path, the diaphragm being biased to a closed position to prevent air from passing the diaphragm along the interior airflow path, the diaphragm being configured to selectively move to an open position to enable air to be drawn into the distal opening, passed the diaphragm, and out of the proximal opening in an inhaling direction in response to a proximal side of the diaphragm being exposed to a predetermined negative air pressure applied at the diaphragm as a suction force; and urging the diaphragm away from the closed position with an actuation surface, m

Abstract: A loading device for inserting a bushing into a through-aperture in a flexible wall or a cap, said bushing having flanges projecting transversely at each end thereof, said flanges being resiliently foldable towards the longitudinal axis of said bushing, said loading device comprising: an inserter rod, a pincher and a loading. When the inserter is pushed distally in an insertion direction, the bushing is forced towards the loading tube which will receive the bushing therein with said flanges folded and projecting substantially axially.

Abstract: An adjustable base plate for use with a tracheotomy stoma includes a flexible membrane and a base component having an accessory mounting portion disposed in a center of the flexible membrane and adapted to mount a tracheostoma accessory. The base plate defines a conically shaped region formed by a plurality of conforming members extending radially from the accessory mounting portion that are laterally spaced from one another and connected to one another by a plurality of web portions formed by the flexible membrane. An adhesive material is applied to the flexible membrane.

Abstract: Implantable splinting devices for supporting a passageway defect in a patient that is formed from one or more support structures including a polymer or a polymer and acellularized tissue matrix that define a structural component that substantially conforms to a defective passageway of the patient. The structural component also has a plurality of pores. The implantable splinting device is capable of being placed around a trachea, a bronchi, an esophagus and a blood vessel of a patient. The implantable splinting device may also be configured for placement between the trachea, and the esophagus of a patient.

Abstract: An exchanger conduit permits temperature and/or humidity conditioning of a gas for a patient respiratory interface. In an example embodiment, a conduit has a first channel and a second channel where the first channel is configured to conduct an inspiratory gas and the second channel configured to conduct an expiratory gas. An exchanger is positioned along the first channel and the second channel to separate the first channel and the second channel. The exchanger is configured to transfer a component (e.g., temperature or humidity) of the gas of the second channel to the gas of the first channel. In some embodiments, an optional flow resistor may be implemented to permit venting at pressures above atmospheric pressure so as to allow pressure stenting of a patient respiratory system without a substantial direct flow from a flow generator of respiratory treatment apparatus to the patient during patient expiration.

Abstract: The invention relates to an intra-laryngeal prosthesis (PIL) for insertion into a larynx, said prosthesis PIL having an upper portion (PH) comprising: a tubular inner wall (1) with a first end, referred to as upper end (2), and a second end, referred to as lower end (3); a tubular outer wall (4) with a first end, referred to as upper end (2) and a second end, referred to as lower end (3), said outer wall (4) surrounding at least a portion of the inner wall (1); a plurality of ribs (5) extending in the direction of the main axis (X) of the prosthesis and connecting the inner wall (1) with the outer wall (4) such that a plurality of cells (6) are formed between the inner wall (1) and the outer wall (4).

Abstract: An example implant system to treat glottic insufficiency is disclosed. The implant system includes a fixation frame including a first set of flanges at a first edge of the fixation frame and a second flange at a second edge of the fixation frame, wherein the fixation frame is configured to secure the implant system at an opening of the patient's thyroid cartilage, a port system disposed in the fixation frame and configured to receive, deliver, maintain, or remove a filler, and a flexible member, coupled to the fixation frame and in fluid or air communication with the port system, wherein based on an amount of the filler in the flexible member, the flexible member is configured to inflate in a direction to push against the patient's arytenoid cartilage so the arytenoid cartilage is rocked, adducted and/or rotated inferomedially.

Abstract: To solve the problem of making available a speech valve for persons who have undergone a laryngectomy or tracheotomy, which speech valve in particular has a long useful life, a speech valve (10) is proposed having a housing (12) with a proximal opening (14) and at least one filter (70) at least partially received in the housing, and with a piston-like valve element (30), wherein the filter at least partially surrounds the valve element, wherein the valve element is movable on a valve seat (32), arranged on the proximal opening, in order to produce a closure position and can be returned with a spring action to an open position of the speech valve, and wherein the valve element has a lower end (38) which faces towards the proximal opening and which is assigned to the valve seat in the open position and, with the valve seat, forms a gap (40) through which an air stream (17a) can be guided.

Abstract: A synthetic organ suitable for transplantation into a biological organism is provided. This synthetic organ includes a three-dimensional polymer scaffold, wherein the shape and dimensions of the polymer scaffold are based on a native organ, wherein the polymer scaffold further includes at least one layer of polymer fibers that have been deposited by electrospinning, and wherein the orientation of the fibers in the scaffold relative to one another is generally parallel, random, or both; and wherein the polymer scaffold has been preseeded with at least one type of biological cell prior to implantation into a biological organism, and wherein the at least one type of biological cell is operative to facilitate integration of the polymer scaffold into the organism so that the polymer scaffold may function in a manner significantly similar to or the same as the native organ.

Abstract: Medical devices, medical device kits, and related methods of treatment are described. An exemplary medical device comprises a proximal portion having an outer surface defining a thread and an inner surface defining a passageway having a keyed portion, a distal portion providing an atraumatic tip, and a flexible main body extending between the proximal portion and the distal portion. The medical device can be positioned in contact with a paralyzed vocal cord to cause a desired medialization for treatment of the vocal cord. The flexible main body allows for deflection upon contact and/or interaction with another device passed into the airway of a treated patient.

Abstract: The invention relates to an intralaryngeal prosthesis which is not at risk of getting blocked and which allows the patient to breathe comfortably. For this purpose, the prosthesis comprises a tubular body pierced by a proximal opening and a convex dome-shaped valve (10), the valve being arranged such that: the distal end (15) of the valve forms a rim (16) which covers a portion of the tubular body (2), and such that a space (17) exists between the distal end (15) of the valve and the tubular body (2) such that air can enter the proximal opening (8) of the tubular body through said space (17).

Abstract: A system, including a first prosthetic device configured to evoke a hearing percept based on a first ambient sound and a second non-invasive device configured to stimulate skin based on a second ambient sound generated by a voice.

Abstract: Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms or fluid filled spaces are disclosed. The systems include an insertable medical device and an in-situ forming foam of lava like materials with a fast forming outer skin and a slower hardening interior that is formed from a one-, two- or multi-part formulation. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.

Abstract: The present invention provides a voice assist apparatus capable of vocalization in a near-natural voice by correctly flowing and blocking voice assist gas during expiration and inspiration, respectively, of a patient even when the pressure inside the operation tube relatively slightly increases and decreases. In the voice assist apparatus, the main body has a first chamber connected with a second end of the voice assist gas-inlet tube, a second chamber connected with a second end of the voice assist tube, a third chamber connected with a second end of the operation tube, a dividing wall dividing between the first chamber and the second chamber except an opening communicating the first chamber with the second chamber, and a membrane formed elastically deformably to open and close the opening and isolates the third chamber from the first chamber and the second chamber.

Abstract: An article and method are presented wherein an implant member is provided that is expandable in at least one direction, the implant adapted for use within an area adjacent vocal folds of a patient, the implant member comprising two or more segments, and a subcutaneous access port providing access for injection of a bulking agent into the implant member.

Abstract: Implantable splinting devices for supporting a passageway defect in a patient that is formed from one or more support structures including a polymer or a polymer and acellularized tissue matrix that define a structural component that substantially conforms to a defective passageway of the patient. The structural component also has a plurality of pores. The implantable splinting device is capable of being placed around a trachea, a bronchi, an esophagus and a blood vessel of a patient. The implantable splinting device may also be configured for placement between the trachea, and the esophagus of a patient.

Abstract: This invention relates to a means for compensating for a whole or partial loss of speech. The means has a sensor unit in the form of a Logometrix pseudo palate and a palatometer which sense the position of a user's tongue while endeavouring to articulate words or sounds. The sensor unit is connected to a comparator which makes use of suitable artificial intelligence algorithms (such as Multi-Layer Perceptron Neural Networks and Hidden Markov Models) together with a library of stored words and sounds as well as tongue positions and signals related to jaw and lip movement as well as inhalation and exhalation to match words or sounds and transmit the matched words or sounds to a loudspeaker. Preferably the output of the loudspeaker will simulate the natural voice of the user.

Abstract: Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms or fluid filled spaces are disclosed. The systems include an insertable medical device and an in-situ forming foam of lava like materials with a fast forming outer skin and a slower hardening interior that is formed from a one-, two- or multi-part formulation. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.

Abstract: The specification discloses compositions and methods for treating a soft tissue defect of an individual.

Abstract: The invention relates to a medical device for supporting an implant or prosthesis, formed by two parts including one part forming an upper ring (1) which is made from a rigid or semi-rigid solid biocompatible material and another part forming a lower ring (2) which is made from a rigid or semi-rigid, integrable or porous biocompatible material, said device being intended to receive an implant or a removable prosthesis at the upper ring and to be installed in situ by means of the lower ring.

Abstract: A synthetic scaffold for replacing at least a portion of an airway includes an airway mold, one or more structural ribs on the airway mold, and a non-structural wall. Each of the one or more structural ribs is formed from a first material and the non-structural wall is formed from a second material. The non-structural wall coats the airway mold and forms a conduit that incorporates the one or more structural ribs.

Abstract: A breathing protector may include a filter housing having a central axis, a distal end, a proximal end, a first opening and a second opening. The second opening may be located in a proximal end of the filter housing and the first opening may be located distally of the second opening, such that the first opening is located upstream of the second opening. An exchanging filter may be disposed in the filter housing and a valve seat may extend around the first opening. A rail, located circumferentially of the valve seat, may extend axially and distally away from the first opening. The rail may include a distal end and at least one rib. A valve member may be arranged in a transversal plane to the central axis and engage the valve seat in a closed position. A return spring may press the valve member into the open position.

Abstract: Systems and devices for minimally invasively treating an air leak in a lung comprise the steps of detecting an air leak in a lung; locating an airway in fluid communication with the air leak, introducing a bronchoscope into a patient's airway to a position adjacent the target section and occluding an airway upstream of the air leak for a period of time. The airway occlusion device is preferably removed after the air leak has substantially permanently healed. The occluding device may be a one-way valve. The occluding device may also comprise strut members and anchors that penetrate an airway wall.

Abstract: Articles, compositions, and methods for growing tissues and organs using bioreactors, including rotating bioreactors, are provided. Synthetic scaffolds for growing artificial tissue and organ transplants are also provided.

Abstract: Bioresorbable stents for treating airway disorders and methods of treatment of the airway disorders using the bioresorbable stents are disclosed. Once implanted, the stents stabilize or maintain an airway lumen. The radial strength of the stents decreases with time which allows the airway to adjust from being artificially supported to a healed state without artificial support. The stent may be removed from the airway through bioresorption without intervention. The bioresorbable stents include a bioresorbable body having a shape that conforms or is conformable to the shape of the of airway lumen.

Abstract: An apparatus and method for treating sleep apnea and/or snoring is provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal and being effective in treating sleep apnea and/or snoring, for example in maintaining openness of an oropharyngeal region of a human or animal during natural sleep, advantageously while not interfering with normal functioning of the epiglottis. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

Abstract: A medical device for regulating fluid flow within one or more lungs of a patient is disclosed. The medical device includes an elongate tubular member, a first extension, a second extension, and a valve member. The elongate tubular member includes a first plurality of channels extending between a proximal and distal ends. The first and second extensions defines a second and third plurality of channels, respectively, each extending from the distal end of the elongate tubular member and configured for placement in a first and second passageway of a lung. The valve member operably couples to the elongate tubular member and is configured to transition between a first position and a second position. The valve member prevents fluid flow to first set of the first plurality of channels in the first position and prevents fluid flow to second set of the first plurality of channels in the second position.

Abstract: The specification discloses compositions and methods for treating a soft tissue defect of an individual.

Abstract: This disclosure is directed primarily to a stent for use in the trachea. The stent has a nominally deployed state, an axially extended state and an axially compressed state. The stent has a length. In the axially extended state, the length is at least 20% greater than in the nominally deployed state.

Abstract: The invention relates to compositions comprising a silk fibroin material, adipose tissue and a compound of the structure where X1 and X5 are independently CH or N; X7 is NH, O or S; X8 and X9 are independently CH or N; R13 is an optionally substituted aryl or optionally substituted heteroaryl and R14 is C1-6 alkyl, optionally substituted aryl or optionally substituted heteroaryl. The composition is administered to a site of a soft tissue condition including those of breast tissue. The silk fibroin material can be in the form of a silk hydrogel, a silk film, a silk scaffold, a silk sheet, a silk porous material or a silk fiber. The silk fibroin material can be substantially sericin free.

Abstract: The invention relates to compositions comprising adipose tissue, a silk fibroin material and a compound of the structure The composition is administered to a site of a soft tissue condition including those of breast tissue. The silk fibroin material can be in the form of a silk hydrogel, a silk film, a silk scaffold, a silk sheet, a silk porous material, a silk fiber or a combination of those materials. The silk material may be substantially sericin free.

Abstract: The invention relates to compositions comprising a hydrogel material that comprises a glycosaminoglycan polymer, adipose tissue and a compound of the structure where X1 and X5 are independently CH or N; X7 is NH, O or S; X8 and X9 are independently CH or N; R13 is an optionally substituted aryl or optionally substituted heteroaryl and R14 is C1-6 alkyl, optionally substituted aryl or optionally substituted heteroaryl. The composition is administered to a site of a soft tissue condition including those of breast tissue. The hydrogel material can be porous or of solid particles. The glycosaminoglycan polymer can be a hyaluronan polymer.

Abstract: The invention relates to compositions comprising a hydrogel material that comprises a glycosaminoglycan polymer, adipose tissue and a compound of the structure The composition is administered to a site of a soft tissue condition including those of breast tissue. The hydrogel material can be porous or of solid particles. The glycosaminoglycan polymer can be a hyaluronan polymer.

Abstract: Tubular prostheses are provided for use in airways, upper digestive, and urinary tracts. Each of these uses has its own specific sets of biological specifications, based on what it must contain and exclude and the physical and chemical pressures and stresses to which it is subjected. The prostheses may be made from allogeneic cells. Thus they can be manufactured and stored prior to an individual's personal need arising.

Abstract: Devices and methods of treating sleep disordered breathing are provided herein. The devices are designed capable of preventing collapse of an oral airway tissue during sleep while maintaining normal velopharyngeal functions.

Abstract: Articles, compositions, and methods for growing tissues and organs using bioreactors, including rotating bioreactors, are provided. Synthetic scaffolds for growing artificial tissue and organ transplants are also provided.

Abstract: The present invention relates to the field of prosthetics having the function of restoring swallowing, breathing and phonation to a patient having a dysfunctional larynx. More specifically, the present invention concerns a valve device forming an intra-laryngeal endoprosthesis intended for implanting in the anatomical larynx in place having the function of enabling breathing while forming a seal against elements such as saliva, mucus or any other element coming from the bolus. The complete intra-laryngeal endoprosthesis, as well as its various applications, are also the subject matter of the present invention.

Abstract: The invention is directed to an anti-migratory stent comprising a tubular structure having an exterior surface and a plurality of protrusions provided on the exterior surface. The plurality of protrusions includes a first set of protrusions and a second set of protrusions. Each of the first and second set of protrusions includes a base and an apex. The apex of each of the first set of protrusions is offset from the base of the first set of protrusions in a direction opposite a direction of offset of the apex of each of the second set of protrusions from the base of the second set of protrusions.

Abstract: A method for reducing mucus accumulation in an airway including disposing an implantable device within an airway, wherein the implantable device has a first end, a second end, and an inner surface defining a lumen extending from the first end to the second end; wherein at least a portion of the inner surface has a hydrophobic polymer coating thereon, wherein a polymer coating surface has dynamic water contact angles of 145 degrees or greater; and wherein the implantable device is constructed and arranged to maintain patency of the airway; wherein accumulation of mucus is reduced as compared to a similar implantable device without the hydrophobic portion of the inner surface. An implantable medical device having a superhydrophobic surface and a method of making an implantable medical device having a superhydrophobic surface are also provided.

Abstract: An article and method are presented wherein an implant member is provided that is expandable in at least one direction, the implant adapted for use within an area adjacent vocal folds of a patient, the implant member comprising two or more segments, and a subcutaneous access port providing access for injection of a bulking agent into the implant member.

Abstract: Methods and devices are disclosed for manipulating the hyoid bone, such as to treat obstructive sleep apnea. An implant is positioned adjacent a hyoid bone. The spatial orientation of the hyoid bone is manipulated, to affect the configuration of the airway. The implant restrains the hyoid bone in the manipulated configuration. The implant is positioned adjacent to pharyngeal structures to dilate the pharyngeal airway and/or to support the pharyngeal wall against collapse.