Helix Medical, Inc.

Edmund V Seder

Frederick L Coe

Stephen W Laguette

Jesse N Nelson

Richard E Houts

David R Suding

Christopher S Mudd

Jeffrey L Goldberg

Juan Madrigal

Tina Porter

William F Sardi

Martin Mitchell

Paul Jason Escobedo

Juan M Madrigal

A voice prosthesis comprising a tubular body portion, a valve and a valve seat disposed within the body portion. The valve seat is further comprised of a medical grade elastomer containing a dispersion of an antimicrobial agent. This valve seat extends the life of the prosthesis by retarding the growth of microorganisms. The body portion of the prosthesis may also contain an antimicrobial agent at a concentration that is non-toxic to the tissue it contacts.

Antimicrobial indwelling voice prosthesis

Microbial growth on the surface of a valve of a voice prosthesis and optionally the cartridge or ring supporting the valve, is inhibited by providing antimicrobial activity at a level sufficient to retard growth of a microbial film by dispersing an inorganic antimicrobial agent such as silver oxide or an organic antimicrobial agent such as triclosan or butyl paraben dispersed in a medical grade silicone elastomer. The valve, ring or cartridge is in contact with body fluids containing microorganisms and nutrients therefor. The antimicrobial surface can interfere with or inhibit the growth of a biofilm, bacterial layer or a yeast layer. The body of the prosthesis may also contain an antimicrobial surface as long as it is non-toxic to the tissue it contacts.

Medical devices having antimicrobial properties

The valve mounting system of the invention incorporates a hard cartridge with a grove on its outer, distal surface and a slot communicating distal from the end of the cartridge with the grove and a specially configured elastomeric valve attached to an outer band with a short tab. The band is positioned with the tab aligned with the slot and is stretched and is slid proximally over the cartridge until the tap enters the slot and the band snaps into the seats in the groove. The width of the slot is the same as the width of the tab providing exact alignment of the valve element with the seat provided in the cartridge. The tab can be disposed at an angle to the seat to preload the valve element against the seat.

Valve mounting assembly for voice prosthesis-cartridge and ring

A brush for a voice prosthesis containing a reduced diameter hard cartridge disposed in the distal section of a soft outer body. The brush includes a reduced diameter distal brush section mounted in a rod having a distal end face larger than the diameter of the cartridge such that the extension of the end of the brush into the opposed esophageal wall is prevented.

Voice prosthesis brush

The length of dwelling of a voice prosthesis in the fistula of a patient is extended by supporting the soft hollow body of the prosthesis with an elongated, rigid cartridge and mounting the flapper valve by means of a tab which extends through a slot in the flange of the cartridge. An enlarged cavity in the flange or the body communicates with the slot and receives the leading portion of the tab. The cavity is filled with adhesive to secure the valve to the cartridge.

Voice prosthesis-cartridge assembly

The position of the rear esophageal flange of a voice prosthesis disposed in a tracheoesophageal fistula is determined by forming a distinctive radiopaque pattern on the flange, preferably by insert molding a radiopaque ring along the perimeter of the flange and radiographically imaging the flange to determine the pattern of the ring. Pattern recognition of the ring is improved by forming the concentric flapper valve of radiopaque material.

Extended dwell voice prosthesis

A hollow, T-shaped body is connected to an extroducer rod by a flexible drain tube. The extroducer rod is longer than a human female vagina, sufficiently stiff to be passed therethrough when the vagina is in a collapsed state, and has a smooth rounded end to facilitate insertion through the vaginal cuff and passage through the vagina during an abdominal hysterectomy. The extroducer rod is also larger in diameter than a Foley catheter which is used to drain the bladder, and formed with external flutes which make it easily distinguishable from the catheter by feel. The T-shaped body has a leg which is connected to the drain tube, and two perpendicular arms. Drain holes are formed through the arms which open in a direction away from the leg. The innermost drain hole of each arm is cut away to a sufficient depth that the arms can collapse to positions parallel to the leg and drain tube to facilitate withdrawal of the body through the vagina. Notches having smooth, rounded walls are formed at desired spacings in the arms to facilitate trimming the arms to fit the patient's anatomy. The rounded walls of the notches and the location of the drain holes which face inwardly toward each other in the collapsed position of the arms prevents irritation of the vaginal wall by sharp edges during withdrawal.

Hysterectomy drain appliance

A silicone catheter wound drain with parallel lumens or passageways formed inside to convey fluid from a wound. The drain has both holes and slots on the outside surface to admit fluid to the lumens and internal openings between the lumens to divert fluid from a blocked lumen to an adjacent lumen and back again after the blockage. The silicon wound drain may contain an embedded, elongated reinforcing fiber to strengthen the wound drain and prevent necking down during removal.

Multiple lumen wound drain with bypass openings

A patient adjustable valve to control the flow of air through an opening surgically created in the neck of the patient. Two concentrically rotatable tubular parts form the outer body and the inner annular sealing surface of the valve. A disk shaped diaphragm proximate the sealing surface allows the free passage of air to the trachea for lower breathing pressures but flaps closed for the higher pressures that precede speech. The normally curled diaphragm is pushed to a flatter, easier to close, position by a cam on the inside of the outer body when the body is rotated relative to the sealing surface.

Adjustable tracheostoma valve

A reversible, flexible, lacrimal duct occluder is formed of a shaft having a low profile cap at one end and a rounded tip at the other end. At least one, preferably 1-3, conical ranges are forward on the shaft between the ends. The rounded tip enters the punctum followed by leading edge of the range(s) until the occluder bends and enters the horizontal canalicular canal. A series of occluders having 1-3 ranges and varying lengths can be provided to accommodate the different canalicular geometries of different individuals. The occluder is readily inserted without the need to use any special introducer tool and is easily removed from the canaliculus of the patient.

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Santa Barbara, CA, United States of America

Edmund V Seder