System for insertion of a voice restoration prosthesis

Abstract: A device (20) and a method for insertion of the device (20) into a puncture (26) in the tracheoesophageal wall (28). The device (20) includes a cylindrical body (22) and a flexible first flange (32) provided on an outside surface of the body (22). The flange (32) has a use orientation in which it projects generally outwardly from the outside surface of the body (22), and an insertion orientation in which it is resiliently folded toward the axis of the body (22). A retainer (44), (144) retains the flange (32) in its resiliently folded orientation. The retainer (44), (144) is removable to permit deployment of the flange (32) to its use orientation. A tool (80) for use in placing the device (20) comprises a cylindrical passageway having a cross section slightly larger than the cross section of the cylindrical body (22), but smaller than the flange (32). The passageway has an open end (84) for receiving the device (20). The edge of the open end (84) causes the flange (32) to be resiliently folded toward an axis of the body (22) as the device (20) is inserted into the passageway. A retainer (44), (144) for retaining the flange (32) in its resiliently folded orientation is received at the open end (84). The device (20) is ejected from the passageway through the open end (84) with the flange (32) retained in its resiliently folded orientation by the retainer (44), (144).

Description: Technical Field This invention relates to an 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. Background Art 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. Patents: 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. EP-A-0222509 discloses a voice prosthesis of flexible material able to be releasably inserted in a tubular holding body of more rigid material to hold the fistula open even while the voice prosthesis has been removed for cleaning or for exchange. WO-87/06817 discloses a prosthesis for sinus drainage, having flexible winglets which may be folded down for passing the prosthesis along a body passage. According to the present invention, there is provided a device for insertion into a puncture in the tracheoesophageal wall, the device including a cylindrical device body having a longitudinal axis and a flexible first flange provided on an outside surface of the device body, the flange having a use orientation in which it projects generally outwardly from the outside surface of the device body and an insertion orientation in which it is resiliently folded toward the longitudinal axis of the device body, and means for retaining the flange in its resiliently folded orientation, the retaining means being constructed of a material soluble in fluids present in the tracheoesophageal wall and the esophagus. The use of soluble material to retain the flange in its resiliently folded orientation provides a system which is extremely easy to use and inexpensive. In one preferred construction the retaining means is one part of a gelatine capsule, of the type used to contain drugs. This is very inexpensive and readily available. The invention also provides a tool for use in placing over the resiliently folded flexible flange of a device according to the invention, the tool comprising a cylindrical passageway having a cross section slightly larger than the cross section of the cylindrical body but smaller than the flange, the passageway having an open end for receiving the device, the edge of the open end causing the flange to be resiliently folded toward a longitudinal axis of the body as the device is inserted into the passageway, means for receiving at the open end the soluble retaining means for retaining the flange in its resiliently folded orientation, and means for ejecting the device from the passageway through the open end with the flange retained in its resiliently folded orientation by the retaining means. 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: Figure 1 illustrates one embodiment of device according to the invention; Figure 2 illustrates a step in a method of insertion of the device of Figure 1 according to the invention; Figures 3 to 5 illustrate steps in a method of placement of a retainer onto a device according to the present invention; Figure 6 illustrates a method for checking the placement of a device according to the present invention; and Figures 7 and 8 illustrate steps in a method of placement of a retainer onto a device according to the present invention. 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 32 in Figures 1 and 2. Flanges 30,32 are retained in these orientations by retainer 44 which illustratively may be cut-off portions of gelatin capsules. Once the voice prosthesis device 20 is inserted into the puncture 26, fluids such as saliva and the like, present in the tracheoesophageal wall 28 and the esophagus 38 dissolve the retainers 44 permitting the flanges 30,32 to assume their use orientations illustrated in Figure 3. Figures 1 and 2 illustrate a method of delivery of a voice prosthesis 20 into a puncture 26. In this method, a retainer 44 is placed over flange 32, folding flange 32 into its non-use, or insertion, orientation. The voice prosthesis 20 is placed on the tip 60 of an insertion tool 62. Insertion tool 62 has a retainer peg 63. Voice prosthesis device 20 is provided with a strap 65 at its tracheal 36 end, illustratively formed on flange 30. Strap 65 is provided with an aperture 67 for accommodating peg 63 to retain prosthesis device 20 on tool 62 during insertion of device 20. Tool 62 is then manipulated through the tracheostoma (such as tracheostoma 50 in Figure 2) of the wearer, and voice prosthesis 20 is inserted through the puncture 26. This properly locates voice prosthesis 20 with flange 30 in its deployed, or use, orientation and flange 32 still captured in its folded, non-use, orientation. However, as retainer 44 is exposed to saliva and the like on the esophageal 38 side of tracheoesophageal wall 28, retainer 44 dissolves and flange 32 deploys to its use orientation, positioning prosthesis 20 in puncture 26. Of course, tool 62 may be removed from prosthesis 20 at any time by removing strap 65 from peg 63, and then withdrawing tool 62. However, again, the clinician may choose to wait to remove tool 62 until flange 32 is deployed. Finally, since strap 65 is not needed once prosthesis 20 is inserted, strap 65 can be clipped from flange 30 and discarded. Figures 3-5 illustrate steps in the loading of a flange, whether it be flange 30 or 32, into a retainer 44 or 144, to the orientation illustrated in Figures 1 and 2. In the first step in the method, illustrated in Figure 3, the prosthesis 20 is inserted into a thin-walled tube 80 to the orientation illustrated in Figure 4. The outer side wall 82 of tube 80 illustratively is knurled or otherwise textured to aid in gripping of the tube 80 during the process. Once the prosthesis has reached the orientation illustrated in Figure 4, the retainer 44 or 144 is placed over the end 84 of the tube 80 from which the edge 86 of the folded flange 30 or 32 projects slightly. Then, referring to Figure 6, a tool 88 of somewhat the same general configuration as tool 62 is pushed through the open end of the tube 80, engages the open end of prosthesis 20 and pushes prosthesis 20 out of tube 80 carrying the retainer 44 or 144 with it to retain flange 30 or 32 in its folded orientation illustrated in Figure 1, 2, 4 or 5. The prosthesis 20 is then ready for insertion using one of the methods described in connection with Figures 1 and 2. It is to be noted that if the insertion method, a step of which is described in connection with Figures 1 and 2 is employed, one test for proper deployment of the flange 32 is illustrated in Figure 6. Namely, if the patient attempts to initiate esophageal speech through prosthesis 20 and too much force is required to get airflow through the prosthesis 20, that is an indication of incomplete deployment of the flange 32. This may mean that dissolution of the retainer 44 is incomplete and/or that the prosthesis 20 is too short to extend all the way through the puncture 26 from the tracheal end 36 to the esophageal end 38 thereof. This provides a convenient technique for use with a measuring probe which is used to measure the length of the puncture 26 between the trachea 36 and esophagus 38 to determine the correct length of prosthesis 20 for the patient. Figures 7 and 8 illustrate steps of an alternative method to that described in connection with Figures 3 and 4 for the loading of a flange 30 or 32 into a retainer 44 or 144, to the orientation illustrated in Figures 1 and 2. In the first step in the method, illustrated in Figure 7, the prosthesis 20 is inserted into a tube 180. The outer side wall 182 of tube 180 again can be knurled or otherwise textured to aid in gripping of the tube 180 during the process. Once the prosthesis has reached the orientation illustrated in Figure 7, the retainer 44 or 144 is placed inside the end 184 of the tube 180. The inside 186 of end 184 is bevelled slightly to help in folding the flange 30 or 32 and to guide retainer 44 or 144 into the end 184 of tube 180. The retainer 44 or 144 is held in the end 184 of tube 180 as prosthesis 20 is pushed out of tube 180 into retainer 44 or 144 by, for example, the clinician's forefinger while a tool 88 is pushed through the tube 180 (Figure 8), engages the open end of prosthesis 20 and pushes prosthesis 20 out of tube 180 carrying the retainer 44 or 144 with it to retain flange 30 or 32 in its folded orientation illustrated in Figures 1, 2, 4 or 5. The prosthesis 20 is then ready for insertion using the methods described in connection with Figures 1 and 2.

Claims: A device for insertion into a puncture (26) in the tracheoesophageal wall, the device including a cylindrical device body (22) having a longitudinal axis and a flexible first flange (32) provided on an outside surface of the device body, the flange having a use orientation in which it projects generally outwardly from the outside surface of the device body and an insertion orientation in which it is resiliently folded toward the longitudinal axis of the device body, and means (44) for retaining the flange (32) in its resiliently folded orientation, the retaining means (44) being constructed of a material soluble in fluids present in the tracheoesophageal wall and the esophagus. A device according to claim 1, wherein the retaining means (44) comprise a tube of soluble material completely surrounding the first flange, when it is folded into its insertion orientation. A device according to claim 2, wherein the tube extends beyond the free ends of the folded flange (32) and is provided with a closed end beyond the folded free end of the flange. A device according to claim 2 or 3, wherein the tube is formed of gelatine. A device according to any preceding claim, wherein the flange (32) is positioned adjacent a first end of the device body which is inserted through the puncture. A device according to claim 5, and further comprising a second flange (30), preferably a flexible flange, spaced along the device body from the first flange toward a second end of the device body. A tool for use in placing over the resiliently folded flexible flange of a device according to any preceding claim, the tool comprising a cylindrical passageway (80,180) having a cross section slightly larger than the cross section of the cylindrical body (22) but smaller than the flange (30,32), the passageway (80,180) having an open end (84,184) for receiving the device, the edge of the open end (84,184) causing the flange (30,32) to be resiliently folded toward a longitudinal axis of the body (22) as the device is inserted into the passageway (80,180), means (82,186) for receiving at the open end the soluble retaining means (44,144) for retaining the flange (30,32) in its resiliently folded orientation, and means (88) for ejecting the device from the passageway through the open end with the flange retained in its resiliently folded orientation by the retaining means. The tool of claim 7, wherein the passageway (80) is defined by an inner side wall of a tube, the tube also having an outer side wall (82), the means for receiving the retaining means (44) comprising the outer side wall adjacent the open end (84) of the passageway. The tool of Claim 7, wherein the passageway (180) is defined by an inner side wall of the tool, the means for receiving the retaining means (144) comprising a bevelled wall (186) between the inner side wall of the tool and the open end (184).

Inventors: BLOM ERIC D, BLOM, ERIC D.
Applicants: HANSA MEDICAL PRODUCTS INC, HANSA MEDICAL PRODUCTS INC.
Application year: 1993
Main classification: A61F2
IPC codes: A61B17, A61F2