USRE39923E1 - Flanged cylindrical implant and method of insertion - Google Patents

Abstract

A device for insertion into a puncture in a tracheoesophageal wall 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. A retainer constructed of a material soluble in fluids present in the tracheoesophageal wall and esophagus retains the flange in its resiliently folded orientation. A method for inserting the device into the puncture comprises the steps of resiliently deflecting the flange toward the axis of the body, placing the retainer over the resiliently folded flange, and either 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, or 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.A device for insertion into an opening in a wall in a human body includes a cylindrical device body having a longitudinal axis and a flexible first flange provided on an outside surface of the device body. The flange has 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 axis of the device body. A retainer retains the flange in its resiliently folded orientation. The retainer is constructed of a material soluble in fluids present adjacent the wall. A method for inserting the device into the opening comprises resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall.

Description

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:

FIG. 1 illustrates a fragmentary sectional view through the tracheoesophageal wall of a wearer of a voice prosthesis device according to the present invention and longitudinally through the voice prosthesis device itself;

FIG. 2 illustrates a step in a method of insertion of the voice prosthesis device ofFIG. 1 according to the invention;

FIG. 3 illustrates a further step in the method, a step of which is illustrated inFIG. 2;

FIG. 4 illustrates a step in another method of insertion of the voice prosthesis device ofFIG. 1 according to the invention;

FIG. 5 illustrates a step in another method of insertion of the voice prosthesis device ofFIG. 1 according to the invention;

FIG. 6 illustrates a step in a method of insertion of the voice prosthesis device ofFIG. 1 according to the invention;

FIG. 7 illustrates a step in a method of insertion of the voice prosthesis device ofFIG. 1 according to the invention;

FIGS. 8,9 and10 illustrate steps in a method of placement of a retainer onto a speech prosthesis according to the present invention;

FIG. 11 illustrates a method for checking the placement of a speech prosthesis according to the present invention; and

FIG. 12-13 illustrate steps in a method of placement of a retainer onto a speech prosthesis according to the present invention.

Turning now to the drawings, avoice prosthesis device20 includes abody22 of a pliable silicone. The silicone must be rigid enough to withstand the forces placed upon it by thewall24 of thepuncture26 through thetracheoesophageal wall28 in which it resides. It must also be pliable enough to permit the folding of theretention flanges30,32 formed on itsoutside surface34 adjacent its tracheal36 and esophageal38 ends, respectively.Flanges30,32 are responsible for positioningbody22 in thepuncture26 and reducing the likelihood of it being displaced in either the tracheal36 or esophageal38 direction.

Flanges30,32 are sufficiently flexible that they can be collapsed or folded into non-use, or insertion, orientations as illustrated byflange30 inFIGS. 2-3 andflange32 inFIGS. 6-7.Flanges30,32 are retained in these orientations byretainer44 which illustratively may be cut-off portions of gelatin capsules. Once thevoice prosthesis device20 is inserted into thepuncture26, fluids such as saliva and the like, present in thetracheoesophageal wall28 and theesophagus38 dissolve theretainers44 permitting theflanges30,32 to assume their use orientations illustrated in FIG.1.

FIGS. 2 and 3 illustrate one method of delivery of avoice prosthesis20 into apuncture26. In this method, a pediatric catheter46 (approximately French size4), preferably, with a Cudé tip, is threaded through thetracheostoma50,puncture26 and upward through thepharynx52 and out through themouth54 of a patient. Thevoice prosthesis20 withflange30 captured by aretainer44 in folded, or insertion, orientation, is then threaded onto thetip48 of thecatheter46. Theretainer44 is provided with a hole53 in the tip thereof through whichcatheter46 is threaded. Aknot55 is tied in thetip48 of thecatheter46 to captureprosthesis20 thereon, and thecatheter46 is pulled back downward through thepharynx52 andpuncture26. This properly locatesvoice prosthesis20 withflange32 in its deployed, use, orientation andflange30 still captured in its folded, non-use orientation. However, asretainer44 is exposed to secretions and the like in theesophagus38 andtracheoesophageal wall28,retainer44 dissolves andflange30 deploys to its use orientation,positioning prosthesis20 inpuncture26. Of course,catheter46 may be removed at any time oncevoice prosthesis20 is in place in the puncture, but the clinician may choose to wait to removecatheter46 untilflange30 is deployed. Thecatheter46 is removed by threading it back up through thepharynx52, out through themouth54, untying theknot55, and then pulling thecatheter46 out through thetracheostoma50.

Steps in two more insertion techniques are illustrated inFIGS. 4-5. In these techniques, aretainer144 is employed which may or may not be soluble in fluids present in the tracheoesophageal wall and the esophagus. These methods work equally well in both cases. In these methods, theretainer144 is placed overflange30 to capture it in either forward folded (FIG. 4) or rearward folded (FIG. 5) orientation. Thecatheter46 is located as in the embodiment ofFIGS. 2-3 and theprosthesis20 withretainer144 thereon is threaded onto thecatheter46 and secured. The prosthesis is pulled downward through thepharynx52 and located in thepuncture26. As illustrated inFIG. 4, the clinician then threads the catheter back up through thepharynx52, unties theknot55, and pulls thecatheter46 out. Finally, the clinician inserts a forceps, tweezers or the like57 through thetracheostoma50, removes theretainer144 and pulls it out, deploying theflange30 to its broken line position illustrated in FIG.4.

A step in another technique for deployingflange30 is illustrated in FIG.5. InFIG. 5,flange30 has been deflected rearwardly during the process of placing aretainer44 or144 on the leading end ofprosthesis20. As in the embodiment illustrated inFIG. 4, thecatheter46 is located as in the embodiment ofFIGS. 2-3 and theprosthesis20 withretainer44 or144 thereon is threaded onto thecatheter46 and secured. The prosthesis is then pulled downward through thepharynx52 and into thepuncture26. However, instead of simply locating theprosthesis20 correctly in thepuncture26, tension is maintained oncatheter46 sufficient to deflect theesophageal side38 of thetracheoesophageal wall28 toward thetracheal side36 thereof. Then theretainer44 is permitted to dissolve or theretainer144 is removed as described in connection withFIG. 4, deployingflange30 to its broken line orientation. Then the tension oncatheter46 is released, permittingprosthesis20 to assume its proper orientation inpuncture26 andcatheter46 is removed, for example as described in connection with FIG.4.

FIGS. 6 and 7 illustrate another method of delivery of avoice prosthesis20 into apuncture26. In this method, aretainer44 is placed overflange32, foldingflange32 into its non-use, or insertion, orientation. Thevoice prosthesis20 is placed on thetip60 of aninsertion tool62.Insertion tool62 has aretainer peg63.Voice prosthesis device20 is provided with astrap65 at its tracheal36 end, illustratively formed onflange30.Strap65 is provided with anaperture67 for accommodatingpeg63 to retainprosthesis device20 ontool62 during insertion ofdevice20.Tool62 is then manipulated through the tracheostoma (such astracheostoma50 inFIG. 2) of the wearer, andvoice prosthesis20 is inserted through thepuncture26. This properly locatesvoice prosthesis20 withflange30 in its deployed, or use, orientation andflange32 still captured in its folded, non-use, orientation. However, asretainer44 is exposed to saliva and the like on the esophageal38 side oftracheoesophageal wall28,retainer44 dissolves andflange32 deploys to its use orientation, positioningprosthesis20 inpuncture26. Of course,tool62 may be removed fromprosthesis20 at any time by removingstrap65 frompeg63, and then withdrawingtool62. However, again, the clinician may choose to wait to removetool62 untilflange32 is deployed. Finally, sincestrap65 is not needed onceprosthesis20 is inserted,strap65 can be clipped fromflange30 and discarded.

FIGS. 8-10 illustrate steps in the loading of a flange, whether it be flange30 or32, into aretainer44 or144, to the orientation illustrated inFIGS. 2-4,6 and7. In the first step in the method, illustrated inFIG. 8, theprosthesis20 is inserted into a thin-walled tube80 to the orientation illustrated in FIG.9. Theouter sidewall82 oftube80 illustratively is knurled or otherwise textured to aid in gripping of thetube80 during the process. Once the prosthesis has reached the orientation illustrated inFIG. 9, theretainer44 or144 is placed over theend84 of thetube80 from which theedge86 of the foldedflange30 or32 projects slightly. Then, referring toFIG. 10, atool88 of somewhat the same general configuration astool62 is pushed through the open end of thetube80, engages the open end ofprosthesis20 and pushesprosthesis20 out of thetube80 carrying theretainer44 or144 with it to retainflange30 or32 in its folded orientation illustrated inFIGS. 2-4,6-7,9 or10. Theprosthesis20 is then ready for insertion using one of the methods described in connection withFIGS. 2-4 and6-7. To load aflange30 or32 to the orientation illustrated inFIG. 5, theretainer44 or144 is simply pushed on an end of theprosthesis20 deflecting theflange30 or32 along the length ofprosthesis20.

It is to be noted that if the insertion method, a step of which is described in connection withFIGS. 6-7 is employed, one test for proper deployment of theflange32 is illustrated in FIG.11. Namely, if the patient attempts to initiate esophageal speech throughprosthesis20 and too much force is required to get airflow through theprosthesis20, that is an indication of incomplete deployment of theflange32. This may mean that dissolution of theretainer44 is incomplete and/or that theprosthesis20 is too short to extend all the way through thepuncture26 from thetracheal end36 to theesophageal end38 thereof. This provides a convenient technique for use with the measuring probe which is used to measure the length of thepuncture26 between thetrachea36 andesophagus38 to determine the correct length ofprosthesis20 for the patient.

FIGS. 12-13 illustrate steps of an alternative method to that described in connection withFIGS. 8-10 for the loading of aflange30 or32 into aretainer44 or144, to the orientation illustrated inFIGS. 2-4,6 and7. In the first step in the method, illustrated inFIG. 12, theprosthesis20 is inserted into atube180. Theouter sidewall182 oftube180 again can be knurled or otherwise textured to aid in gripping of thetube180 during the process. Once the prosthesis has reached the orientation illustrated inFIG. 12, theretainer44 or144 is placed inside theend184 of thetube180. The inside186 ofend184 is bevelled slightly to help in folding theflange30 or32 and to guideretainer44 or144 into theend184 oftube180. Theretainer44 or144 is held in theend184 oftube180 asprosthesis20 is pushed out oftube180 intoretainer44 or144 by, for example, the clinician's forefinger while atool88 is pushed through the tube180 (FIG.13), engages the open end ofprosthesis20 and pushesprosthesis20 out oftube180 carrying theretainer44 or144 with it to retainflange30 or32 in its folded orientation illustrated inFIGS. 2-4,6-7,9 or10. Theprosthesis20 is then ready for insertion using one of the methods described in connection withFIGS. 2-4 and6-7.

Claims (20)

1. In combination, a device for insertion into a puncture in a tracheoesophageal wall, the device including a cylindrical body having a longitudinal axis and a flexible first flange provided on an outside surface of the body, the flange extending radially outward from the axis of the body and being continuous radially outward from the body to a radially outer edge of the flange, the flange having 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, 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 an esophagus partially bounded by the tracheoesophageal wall.

2. The apparatus ofclaim 1 wherein the first flange is positioned adjacent a first end of the body which is inserted insertable through the puncture.

3. The apparatus ofclaim 2 and further comprising a second flange spaced along the body from the first flange toward a second end of the body.

4. The apparatus ofclaim 3 wherein the second flange is a flexible flange.

5. A method for inserting into a puncture an opening in a tracheoesophageal wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and , placing over the resiliently folded flange a retainer of a material soluble in fluids present in adjacent the tracheoesophageal wall and an esophagus partially bounded by the tracheoesophageal wall inserting the device into the opening.

6. The method ofclaim 5 wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, from the first side into the puncture opening so that the resiliently folded flange lies on an esophageal the second side of the tracheoesophageal wall.

7. The method ofclaim 5 A method for inserting into an opening in a wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall, the wall having a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, from the second side into the puncture to opening so that the resiliently folded flange lies on a tracheal the first side of the tracheoesophageal wall.

8. The method ofclaim 5 wherein A method for inserting into an opening in a wall in a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer of a material soluble in fluids present adjacent the wall, the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer comprise comprising the steps of inserting the device body in a first direction into an opening of an instrument having a cross section slightly larger than a cross section of the device body transverse to its longitudinal axis far enough that contact with a wall of the opening of the instrument collapses the flange, placing the retainer over the collapsed flange and pushing the device body in a second direction opposite the first out of the opening.

9. The method ofclaim 8 wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, from the first side into the puncture opening so that the resiliently folded flange lies on the esophageal second side of the tracheoesophageal wall.

10. The method ofclaim 8 wherein the wall has a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, from the second side into the puncture opening so that the resiliently folded flange lies on a tracheal the first side of the tracheoesophageal wall.

11. In combination, a device for insertion into a puncture in a tracheoesophageal wall, the device including a cylindrical body and a flexible first flange provided on an outside surface of the body, the flange having 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, and means for retaining the flange in its resiliently folded orientation, the retaining means being removable to permit deployment of the flange to its use orientation.

12. The apparatus ofclaim 11 wherein the first flange is positioned adjacent a first end of the body which is inserted through the puncture.

13. The apparatus ofclaim 12 and further comprising a second flange spaced along the body from the first flange toward a second end of the body.

14. The apparatus ofclaim 13 wherein the second flange is a flexible flange.

15. A method for inserting into a puncture in a tracheoesophageal wall a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non-use orientation, inserting the device with the retainer in place into the puncture, and removing the retainer to permit deployment of the flange to its use orientation.

16. The method ofclaim 15 wherein the wall has a first tracheal side and a second esophageal side, and the step of inserting the device with the retainer in place into the puncture comprises the step of pushing the device body, resiliently folded flange first, into the puncture so that the resiliently folded flange lies on an esophageal the second side of the tracheoesophageal wall.

17. The method ofclaim 15 wherein A method for inserting into an opening in a wall of a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non-use orientation, inserting the device with the retainer in place into the opening, and removing the retainer to permit deployment of the flange to its use orientation, the wall having a first side and a second side,the step of inserting the device with the retainer in place into the puncture comprises opening comprising the step of pulling the device body, resiliently folded flange first, into the puncture opening so that the resiliently folded flange lies on a tracheal the first side of the tracheoesophageal wall.

18. The method ofclaim 15 wherein A method for inserting into an opening in a wall of a human body a device including a cylindrical device body having a longitudinal axis and a flexible flange provided on an outside surface of the device body and having a use orientation in which it projects generally outwardly from the outside surface of the device body comprising the steps of resiliently deflecting the flange toward the axis of the device body, placing over the resiliently folded flange a retainer for retaining the flange in a folded non-use orientation, inserting the device with the retainer in place into the opening, and removing the retainer to permit deployment of the flange to its use orientation,the steps of resiliently deflecting the flange toward the axis of the device body and placing over the resiliently folded flange a retainer comprise comprising the steps of inserting the device body in a first direction into an opening of an instrument having a cross section slightly larger than a cross section of the device body transverse to its longitudinal axis far enough that contact with a wall of the opening of an the instrument collapses the flange, placing the retainer over the collapsed flange and pushing the device body in a second direction opposite the first out of the opening.

19. The method ofclaim 18 wherein the wall has a first side and a second side, and further comprising the step of pushing the device body, resiliently folded flange first, into the puncture opening so that the resiliently folded flange lies on an esophageal the second side of the tracheoesophageal wall.

20. The method ofclaim 18 wherein the wall has a first side and a second side, and further comprising the step of pulling the device body, resiliently folded flange first, into the puncture opening so that the resiliently folded flange lies on a tracheal the first side of the tracheoesophageal wall.

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