|Publication number||USRE39923 E1|
|Application number||US 08/393,185|
|Publication date||Nov 20, 2007|
|Filing date||Feb 23, 1995|
|Priority date||Jan 10, 1992|
|Also published as||DE69317445D1, DE69317445T2, EP0551198A1, EP0551198B1, US5300119, US5571180|
|Publication number||08393185, 393185, US RE39923 E1, US RE39923E1, US-E1-RE39923, USRE39923 E1, USRE39923E1|
|Inventors||Eric D. Blom|
|Original Assignee||Hansa Medical Products, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (16), Non-Patent Citations (3), Referenced by (27), Classifications (15)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to a method and apparatus for the delivery, or placement, of, for example, a voice prosthesis device into a puncture provided in the tracheoesophageal wall of a speech restoration patient.
A speech restoration technique is known wherein air from the trachea is diverted from its normal flow path out through the tracheostoma to a flow path through a voice prosthesis providing a more or less permanent passageway to the esophagus. Esophageal speech results. See U.S. Pat. Nos. 4,435,853; 4,614,516; and 4,911,716. Voice prostheses currently in use for providing controlled air pathways through tracheoesophageal punctures incorporate flexible retention collars. The retention collar lies against the esophageal surface of the tracheoesophageal wall to reduce the likelihood of dislodgement of the prosthesis from the puncture. While this configuration substantially improves retention, the presence of the large retention collar makes insertion of a prosthesis more difficult and traumatic to the tissue surrounding the tracheoesophageal puncture. A possibility inherent in difficult or traumatic prosthesis insertion is incomplete insertion. Incomplete insertion may result in aspiration of the prosthesis into the airway. The prosthesis may be expelled by coughing, requiring endoscopic retrieval from the airway. Additionally, concern about prosthesis insertion difficulty may prevent some patients and physicians from employing this method of voice restoration.
According to an aspect of the invention, a retainer is provided for atraumatic insertion of a prosthesis into a puncture in the tracheoesophageal wall. The prosthesis includes a cylindrical body and a flexible first flange provided on an outside surface of the body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body and an insertion orientation in which it is resiliently folded toward the axis of the body. The retainer retains the flange in its resiliently folded orientation.
The retainer illustratively is constructed of a material soluble in fluids present in the tracheoesophageal wall and the esophagus.
Illustratively, the first flange is positioned adjacent a first end of the body which is inserted through the puncture.
Additionally, illustratively, the prosthesis further comprises a second flange spaced along the body from the first flange toward a second end of the body. Illustratively, the second flange is also a flexible flange.
According to another aspect of the invention, a method is provided for atraumatically inserting into a puncture in the tracheoesophageal wall a prosthesis including a cylindrical body and a flexible flange provided on an outside surface of the body. The flange has a use orientation in which it projects generally outwardly from the outside surface of the body. The method comprises the steps of resiliently deflecting the flange toward the axis of the body and placing over the resiliently folded flange a retainer.
Illustratively the retainer is constructed of a material soluble in fluids present in the tracheoesophageal wall and the esophagus.
Illustratively, the method further comprises the step of pushing the body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on the esophageal side of the tracheoesophageal wall.
Alternatively, the method further comprises the step of pulling the body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on the tracheal side of the tracheoesophageal wall.
The term “cylindrical body”, as used herein, means a body including a surface generated by a straight line moving always parallel to another straight line in a closed path.
The invention may best be understood by referring to the following detailed description and accompanying drawings which illustrate the invention. In the drawings:
Turning now to the drawings, a voice prosthesis device 20 includes a body 22 of a pliable silicone. The silicone must be rigid enough to withstand the forces placed upon it by the wall 24 of the puncture 26 through the tracheoesophageal wall 28 in which it resides. It must also be pliable enough to permit the folding of the retention flanges 30, 32 formed on its outside surface 34 adjacent its tracheal 36 and esophageal 38 ends, respectively. Flanges 30, 32 are responsible for positioning body 22 in the puncture 26 and reducing the likelihood of it being displaced in either the tracheal 36 or esophageal 38 direction.
Flanges 30, 32 are sufficiently flexible that they can be collapsed or folded into non-use, or insertion, orientations as illustrated by flange 30 in
Steps in two more insertion techniques are illustrated in
A step in another technique for deploying flange 30 is illustrated in FIG. 5. In
It is to be noted that if the insertion method, a step of which is described in connection with
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|US8332999 *||Apr 8, 2005||Dec 18, 2012||Atos Medical Ab||Method and device for securely loading and mounting a tubular device in a flexible wall and manufacturing method for said loading device|
|US8535707||Jul 9, 2007||Sep 17, 2013||Intersect Ent, Inc.||Devices and methods for delivering active agents to the osteomeatal complex|
|US8585730||Dec 12, 2008||Nov 19, 2013||Intersect Ent, Inc.||Self-expanding devices and methods therefor|
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|US8784487 *||Apr 13, 2012||Jul 22, 2014||Helix Medical, Llc||Catheter for inserting a voice prosthesis|
|US8802131||Aug 14, 2009||Aug 12, 2014||Intersect Ent, Inc.||Devices and methods for delivering active agents to the osteomeatal complex|
|US8858974||Nov 13, 2008||Oct 14, 2014||Intersect Ent, Inc.||Device and methods for treating paranasal sinus conditions|
|US8986341||Nov 15, 2013||Mar 24, 2015||Intersect Ent, Inc.||Self-expanding devices and methods therefor|
|US20090102180 *||Apr 8, 2005||Apr 23, 2009||Atos Medical Ab||Method and Device for Securely Loading and Mounting a Tubular Device in a Flexible Wall and Manufacturing Method for said Loading Device|
|US20090177272 *||Dec 12, 2008||Jul 9, 2009||Abbate Anthony J||Self-expanding devices and methods therefor|
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|US20100043197 *||Jul 30, 2009||Feb 25, 2010||Abbate Anthony J||Methods and devices for crimping self-expanding devices|
|US20100100170 *||Oct 16, 2009||Apr 22, 2010||Boston Scientific Scimed, Inc.||Shape memory tubular stent with grooves|
|US20110004194 *||Sep 15, 2010||Jan 6, 2011||Eaton Donald J||Device and methods for treating paranasal sinus conditions|
|US20110093071 *||Dec 22, 2010||Apr 21, 2011||Helix Medical, Llc||Voice Prothesis Automatic Flange Deployment Confirmation Method|
|US20130274876 *||Apr 13, 2012||Oct 17, 2013||Helix Medical, Llc||Catheter for Inserting A Voice Prosthesis|
|USD702834 *||Mar 22, 2011||Apr 15, 2014||Medimop Medical Projects Ltd.||Cartridge for use in injection device|
|EP2110101A2||Apr 7, 2009||Oct 21, 2009||Helix Medical, LLC||Voice prosthesis automatic flange deployment confirmation method|
|EP2110152A2||Apr 7, 2009||Oct 21, 2009||Helix Medical, LLC||Voice prosthesis dilator/sizer|
|EP2649952A1||Feb 7, 2013||Oct 16, 2013||Helix Medical LLC||Trocar and device for measuring a tracheoesophageal puncture|
|EP2649963A1||Feb 7, 2013||Oct 16, 2013||Helix Medical LLC||Catheter for inserting a voice prothesis|
|U.S. Classification||623/9, 128/207.29, 600/29, 128/887, 623/14.11, 623/23.64, 128/207.14|
|International Classification||A61B17/00, A61F2/18, A61F2/20|
|Cooperative Classification||A61F2/203, A61B2017/00654, A61B17/0057, A61B2017/00659|