News Column

Researchers Submit Patent Application, "Dilator for Inserting a Voice Prosthesis", for Approval

September 4, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventors Margolin, Gregori (Stockholm, SE); Karling, Jonas (Nacka, SE); Magnusson, Ronny (Horby, SE), filed on April 22, 2014, was made available online on August 21, 2014.

The patent's assignee is Atos Medical AB.

News editors obtained the following quote from the background information supplied by the inventors: "In the field of laryngectomy a voice prosthesis is often used for tracheoesophagal speech. The voice prosthesis is then placed in a puncture in the tracheoesophageal wall. The voice prosthesis may be placed in said puncture directly after the voice box is removed and the trachea is sutured to the skin of the neck--so called primary puncture--or after time of surgery, under general anesthesia--so called secondary puncture. A voice prosthesis has a tubular body, with a flange in each end. The tubular body is to be mounted in the tracheoesophageal wall with a flange situated on the tracheal side, substantially hindering movement of the voice prosthesis into the oesophagus, and the other flange situated on the ocsophagal side, hindering movement of the voice prosthesis into the trachea. A valve member is located in the lumen of the tubular body. The voice prosthesis may also be provided with a safety strap, arranged on the flange intended to be situated on the tracheal side.

"Laryngectomy is in most cases performed in cases of laryngeal cancer.

"To create a tracheoesophageal puncture during primary puncture, a pharynx protector is inserted in the esophagus until the tip of the pharynx protector reaches the intended puncture site. The pharynx protector is a hollow, rigid, and cylindrical device with a handle. It is inserted in the pharynx/esophagus to protect the posterior wall during puncture. The tip of the device has normally an oblique opening, which is palpated by the surgeon to verify the correct position for puncture. The tip of the pharynx protector is palpated through the tracheoesophageal wall to verify the correct placement of the puncture. The puncture is made with a troachar through the tracheoesophageal wall against the pharynx protector. The troachar is a thick and hollow instrument, normally made of stainless steel. The troachar is used to create the puncture and to facilitate the subsequent introduction of a guide wire, which is inserted through the hollow part of the troachar.

"The guide wire may be a flexible plastic tube, which is plastically deformable. The troachar may have a bent tip in order to direct the guide wire into the hollow cylindrical part of the pharynx protector. The troachar is oriented so that a bent tip thereof directs a guide wire--subsequently inserted through the troachar--into the lumen of the pharynx protector. Next, the guide wire is introduced through the troachar until the distal tip of the guide wire extends approximately 20 cm through the pharynx protector. The troachar and the pharynx protector are removed, leaving the guide wire in place through the puncture of the tracheoesophageal wall. Thereafter, a voice prosthesis is arranged on the guidewire and pulled through the tracheoesophageal puncture.

"During secondary puncture a rigid esophagoscope is generally inserted in the esophagus instead of a pharynx protector until the tip of the esophagoscope can be palpated at the puncture site. The puncture is then made with the troachar against the esophagoscope which acts as a pharynx protector.

"U.S. Pat. No. 6,159,243 discloses a voice prosthesis implantation kit including; a leader element, which can be introduced via the mouth to the location where the voice prosthesis is to be implanted; a hollow cutting element for cutting the wall of oesophagus, said leader element having a first coupling device in one end; a guide element, which in one end may be coupled to said first coupling element, and in the other end carrying an dilator for a voice prosthesis. The dilator may be screwed into engagement with the guide element, said guide element having a cavity in the other end thereof, in which cavity the voice prosthesis may be mounted by pushing a flange of the voice prosthesis into the cavity. The kit according to U.S. Pat. No. 6,159,243 is only usable for secondary puncture; the voice prosthesis can not be pre-loaded in the dilator, since one of the flanges is pushed into the cavity of the voice prosthesis, whereby the risk of plastic deformation is high; the guide element is screwed into engagement with the dilator in the thin end of the dilator, putting high demands on attachment mechanism, since the pulling of the kit through the puncture wants to depart the dilator from the guide element. Also, since the kit according to U.S. Pat. No. 6,159,243 is adapted to pull the voice prosthesis through the neck into position, it is impossible to control if the inner flange is fully unfolded on the oesophagal side. Furthermore, as the oesophagal flange is folded and pushed into a gripping cavity keeping the flange in folded position, the holding force is very limited. Thus, the risk of disengagement between the cavity and the voice prosthesis is quite high; especially, since the flange of the voice prosthesis is of a substantially flexible material.

"Hence, an improved inserting system would be advantageous, and in particular a dilator allowing for use in both primary and secondary puncture; allowing for pre-loading of the voice prosthesis in the dilator prior to usage, i.e. a dilator not risking plastic deformation of flanges on the voice prosthesis; a dilator allowing for a more effective and easy to assemble attachment mechanism between the dilator and the guide wire, would be advantageous."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a inserting system with a dilator, said dilator comprising a voice prosthesis holding portion connected to said substantially conical body by a connecting portion, said holding portion having a central passage, said central passage being configured to have the tubular body of the voice prosthesis positioned therethrough, such that the flanges of the voice prosthesis are substantially unfolded proximally and distally of said central passage. A wirelock comprised in said inserting system is also provided.

"Advantageous features hereof are embodied in the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

"These and other aspects, features and advantages of which the invention is capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which

"FIGS. 1a to 1c illustrate one embodiment of a dilator according to the present invention;

"FIG. 2 illustrates another embodiment of a dilator of the present invention;

"FIG. 3 illustrates another embodiment of a dilator of the present invention;

"FIGS. 4, 5, 6a, and 6b illustrate one embodiment of a wire lock according to the present invention; and

"FIGS. 7a to 7c illustrates the cooperation between a guide wire and a wire lock according to an embodiment of a procedure of the present invention."

For additional information on this patent application, see: Margolin, Gregori; Karling, Jonas; Magnusson, Ronny. Dilator for Inserting a Voice Prosthesis. Filed April 22, 2014 and posted August 21, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1162&p=24&f=G&l=50&d=PG01&S1=20140814.PD.&OS=PD/20140814&RS=PD/20140814

Keywords for this news article include: Prosthetics, Atos Medical AB, Medical Devices.

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Source: Politics & Government Week


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