Abstract:
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.

Description:
TECHNICAL FIELD  
         [0001]    This invention relates to a voice prosthesis and more particularly this invention relates to a mounting assembly for a valve.  
         BACKGROUND OF THE INVENTION  
         [0002]    There are several options for restoring speech to patients who have had their larynx removed. One procedure is to surgically create a puncture or fistula between the tracheal and the esophagus. A trachea voice prosthesis containing a one-way valve such as a BLOM-SINGER® voice prosthesis is inserted into the trachea-esophageal fistula. The one-way valve protects the airway during swallowing but opens under positive pressure. The voice prosthesis, thus, permits a patient to divert air from the lungs into the esophagus and out through the mouth. Speech is created during passage of air through the upper part of the esophagus.  
           [0003]    The prosthesis maintains the fistula open, transfers air from the trachea to the esophagus for voice production and prevents esophageal leakage into the trachea during swallowing. However, the prosthesis being in contact with moisture in a hot, dark environment is subject to growth of commonly found yeast formation, typically Candida Albicans on the valve and the retaining flange. The growth of yeast can interfere with function of the valve and can cause the flange to wrinkle and leak.  
           [0004]    The current low pressure voice prosthesis can be removed by the patient every few days and can be replaced with a clean prosthesis. The removed prosthesis is soaked in hydrogen peroxide to remove the layer of yeast from the valve and flange. Some patients such as quadriplegic patients or patients suffering from neurological conditions such as Multiple Sclerosis have difficulty managing frequent removal and reinsertion of the prosthesis. Others, who are physically handicapped are not able to remove, sterilize, or reinsert the prosthesis.  
           [0005]    A longer dwelling, low pressure voice prosthesis has been developed that can remain in place in the trachea-esophageal fistula for over 3-4 days, depending on the patient and conditions of use. The patient can confidently use the prosthesis for longer periods. Trips to a health care specialist to remove and replace the prosthesis are greatly extended providing increased comfort and lower cost to the patient.  
           [0006]    The flange or collar that rests against the trachea-esophageal wall is strengthened by increasing the thickness and/or diameter of the flange. The stronger flange is more resistant to wrinkling or detachment from the wall. The voice prosthesis can remain in place in the fistula for much longer periods without allowing leakage between the trachea and the esophagus. The stronger and larger collar also reduces possibility of dislodgment of the prosthesis during a coughing or sneezing episode. However, the thicker and wider flange is more difficult to insert through the fistula and does not reliably seat on the trachea-esophageal wall.  
           [0007]    Yeast growth on the valve can also cause distortion of the shape of the valve or form wrinkles in the body of the valve which prevents the valve from closing.  
           [0008]    Leaking also appears to be due to distortion of the valve body adjacent to the seat of the valve and to yeast growth on the seat. Forming the valve with an arcuate dome shape increased resistance to folding or bending of the valve. However, some valves still leaked after extended placement in a fistula.  
         LIST OF REFERENCES U.S. Pat. No. 5,314,470 U.S. Pat. No. 5,578,803 U.S. Pat. No. 5,480,432  
       STATEMENT OF THE PRIOR ART  
         [0009]    U.S. Pat. No. 5,314,470 discloses a soft voice prosthesis which includes a stiffening ring  14  inserted into a groove in the body of the prosthesis. Though the ring stiffens the body adjacent the valve does not prevent distortion of the body by muscular movement or distortion of the valve by growth of yeast. The valve is thin, it is not dome shaped and is not pre-loaded. It will readily distort when a layer of yeast grows on its surface. Furthermore, the flap valve is attached to the soft body with a segment that remains after cutting the valve from the body. This is a labor intensive step and the thin segment does not provide a secure and reliable attachment of the valve to the prosthesis. If the segment should sever, the valve could fall into the lungs of the user.  
           [0010]    U.S. Pat. No. 5,578,083 issued Nov. 26, 1996 discloses the use of a rigid cartridge. The cartridge prevents distortion of the soft body of the prosthesis. The valve contains a mounting tab normal to the body of the valve which is potted into a slot in the cartridge. The valve and cartridge are very small, especially the tab and slot. They are difficult to manipulate. Correct seating of the tab in the slot is not reliable resulting in a high percentage of prosthesis in which the valve does not seal when in the closed position and must be discarded.  
         STATEMENT OF THE INVENTION  
         [0011]    The valve mounting system of the invention is easy to manipulate and install. The valve mounting system reliably seats the valve in correct position. Adhesive is not necessary to achieve reliable and long term functioning of the valve. The valve mounting system of the invention incorporates a hard cartridge with a groove on its outer, distal surface and a slot communicating distal from the end of the cartridge with the groove and a specially configured elastomeric valve attached to an outer band with a short tab. The band is positioned with the tab designed with the slot and is stretched and slid proximally over the cartridge until the tab enters the slot and the band snaps into and 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.  
           [0012]    The cartridge-valve assembly is then inserted into a recess provided in the channel of the soft body of a voice prosthesis. The cartridge and valve are not in direct contact with tissue and can contain antimicrobial agents to prevent or retard growth of microbial films.  
           [0013]    The valve may optionally be dome-shaped to provide further strengthening of the valve and to assure that it will not distort and leak even when encrusted with a layer of yeast.  
           [0014]    These and many other features and attendant advantages of the invention will become apparent as the invention becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    [0015]FIG. 1 is a view in section of a valve with seating band according to the invention;  
         [0016]    [0016]FIG. 2 is a view in section of a hard cartridge with valve seat according to the invention;  
         [0017]    [0017]FIG. 3 is a view in section of a soft body for a voice prosthesis according to the invention;  
         [0018]    [0018]FIG. 4 is a view in section of the assembly of the body, cartridge and valve illustrated in FIGS. 1-3;  
         [0019]    [0019]FIG. 5 is a top view in elevation of an alternate embodiment of a valve;  
         [0020]    [0020]FIG. 6 is a perspective and sectional view of the valve illustrated in FIG. 5;  
         [0021]    [0021]FIG. 7 is a view in section taken along lines  7 - 7  of FIG. 6;  
         [0022]    [0022]FIG. 8 is a perspective view of an alternate embodiment of a cartridge;  
         [0023]    [0023]FIG. 9 is a top view in elevation of the cartridge illustrated in FIG. 8;  
         [0024]    [0024]FIG. 10 is a view in section taken along lines  10 - 10  of FIG. 9;  
         [0025]    [0025]FIG. 11 is a perspective sectional view of the assembly of a valve with the cartridge illustrated in FIG. 8;  
         [0026]    [0026]FIG. 12 is a top view in elevation of the assembly illustrated in FIG. 11; and  
         [0027]    [0027]FIG. 13 is a view in sections taken along lines  13 - 13  of FIG. 12. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0028]    Referring now to FIGS. 1-4, FIG. 1 illustrates an elastomer flapper valve  10  formed of a valve element  11  spaced from and connected to a surrounding mounting band  12  by a tab  14  extending from the outer surface  16  of the valve element to inner surface  18  of the band  12 . The rigid cartridge  20  shown in FIG. 2 has a groove  22  formed in the outer surface  24  and a slot  26  formed in the distal surface  28  extending from the distal surface  28  to the groove  22 . The width of the slot  26  is coextensive with the width of the tab  14 . The outer edges of the distal surface  28  is rounded at  30  to prevent tearing of the mounting band  12  as it is assembled with the cartridge  20 . The outer edge  32  of the proximal surface of the cartridge  20  can also be chamfered or rounded to prevent tearing of the soft body  34  of the voice prosthesis  36 .  
         [0029]    The cartridge  20  contains a boss  37  extending into the channel  38  through the cartridge forming on its distal surface a seat  40  for the valve element  11 . The seat  40  can be disposed normal to the axis of the channel or can be slanted at an angle of 5-10 degrees as illustrated in FIG. 9. The proximal face  42  of the boss  37  can be utilized to engage the distal end of a cleaning brush or insertion tool. The edge  44  of the proximal face  42  can be chamfered.  
         [0030]    Referring again to FIGS.  1  to  4  the voice prosthesis  36  is assembled by stretching the band  12  while aligning the tab  14  with the slot  26 . The stretched band  12  is then placed over the groove  22  while the tab  14  is seated in the slot  26  against the seat  40  and released into the groove  22 . The proximal face  46  of the valve element  11  is reliably seated against the valve seat  40 . The valve element  11  may have a dome shape  48  to strengthen the element and prevent wrinkling of the element.  
         [0031]    The cartridge-valve assembly  50  is then pushed through the distal end  52  of the soft body  34  until it seats in the annular recess  54  within the soft body  34 . The soft body  34  can also contain a conventional distal flange  58  and proximal flange  60  for engaging the surfaces of wall between a trachea and esophagus. The distal flange  60  can contain a radioplaque ring  61  in order to assure that the flange  60  is correctly seated as disclosed in Ser. No. 08/282,277 filed Jul. 27, 1994 now issued as U.S. Pat. No. 5,480,432, the disclosure of which is expressly incorporated herein by reference. The soft body  34  can contain a distal hood  63  to further protect the valve element  1  from being fouled.  
         [0032]    Referring now to FIGS. 5-7, an alternate embodiment of a valve  110  can be preloaded by forming the tab  114  at an angle from 5 to 20% to a plane normal to the axis of the mounting band  112 . The valve element  111  will preload when assembled with a cartridge, not shown.  
         [0033]    Referring now to FIGS. 8-10, another way to preload a valve element, not shown, is to form the seating face  240  of a-cartridge  220  at an angle of 5-20 degrees by disposing the face  240  at the slot  226  forward of the opposed face  228 . The cartridge  220  illustrated in FIGS. 8-10 contains three flanges, a proximal flange  270 , a central flange  272  and a distal flange  274  forming a first groove  222  between flanges  272  and  274  for receiving a mounting band of a valve, not shown and a second groove  276  for receiving a cylindrical boss on the body of a prosthesis, not shown, for better securing the assembly of the soft body and the cartridge  220 .  
         [0034]    Referring now to FIGS. 11-13 a valve  210  is illustrated assembled with the cartridge  220 . The edge portion  280  of the valve element  211  opposite the tab  214  is preloaded by *being faced rearwardly by the slanted seating surface  240 .  
         [0035]    The Indwelling Low Pressure Voice Prosthesis of the invention is designed for those persons who are unable or resistant to changing the voice prosthesis every two or three days as was recommended for the non-indwelling, patient-removable Low Pressure Voice Prosthesis. The Indwelling Low Pressure Voice Prosthesis has been specifically designed to maintain the placement of the prosthesis in the trachea-esophageal puncture so that routine changing of the device is not necessary.  
         [0036]    The Indwelling Low Pressure Voice Prosthesis is loaded into a gelatin capsule, using a gel cap loading tool. The gel cap provides a smooth, rounded shape to the tip end of the voice prosthesis, thus enabling easier entry into the trachea-esophageal puncture when placed by the clinician.  
         [0037]    The prosthesis is placed in the fistula by inserting the strap of the voice prosthesis into the center hole on the top side of the gel cap loading tool and gently pulling the prosthesis down and through this opening until the rear esophageal flange is positioned over this center hole.  
         [0038]    The tubular portion of the voice prosthesis is grasped and the prosthesis is very slowly pulled down further, such that the rear flange on the tip of the voice prosthesis begins to fold forward inside the center hole. Over-pulling will cause the voice prosthesis to be pulled completely through the loading device. The gel cap is placed over the center hole in the loading tool and into the groove, such that it is securely in place. A fingertip is placed on the tip of the gel cap while simultaneously pushing the voice prosthesis back up through the center hole and out of the loading device. The prosthesis is pushed, gently until the folded, rear flange is fully residing in the gel cap. The pushrod provided with the gel cap loading tool may be used to push the device through from the back.  
         [0039]    The gel cap-tipped end of the voice prosthesis is gently grasped and the prosthesis is carefully pulled the rest of the way back up through the loading device. The prosthesis is placed on the inserter, and the strap attached over the safety peg, as shown in U.S. Pat. No. 5,064,433, the disclosure of which is expressly incorporated herein by reference. The position of the gel cap on the tip of the voice prosthesis is inspected to assure that it is securely and fully encapsulating the rear flange.  
         [0040]    A light coating of water or water-soluble lubricant (oil-free) is applied to the tip of the gel-capped end of the voice prosthesis and the voice prosthesis is immediately inserted fully into the trachea-esophageal puncture by aligning the tip of the voice prosthesis partially in the puncture with the neck strap oriented upwards. The prosthesis is held in this position of full insertion for at least 3 minutes. This allows time for the gel cap to dissolve and release the retention collar within the esophagus.  
         [0041]    If the prosthesis does not insert easily on the first attempt, do not continue to try to insert. Instead, a clean 22 French trachea-esophageal dilator is inserted for a few minutes to dilate the pathway.  
         [0042]    The voice prosthesis strap is detached from the safety peg on the inserter. A finger is placed against the strap and the inserter is carefully withdrawn from the prosthesis with a twisting motion. A piece of tape is placed over the voice prosthesis strap against the skin.  
         [0043]    The Indwelling Low Pressure Voice Prosthesis of the invention is designed to permit optional detachment of the strap by a physician or trained speech pathologist following confirmation that the rear flange on the prosthesis is fully opened and securely positioned.  
         [0044]    The rear flange emerges from the dissolved gel cap and unfurls within the esophageal lumen. Seating of the rear flange against the anterior wall of the esophagus, can be confirmed by rotating the inserted prosthesis within the puncture while it is attached to the inserter. A correctly and securely inserted prosthesis will rotate freely. Rotate the prosthesis repeatedly  360   a . Slight resistance may be detected on the first rotation because of residual gelatin that has not completely dissolved. Allow at lest three minutes for the gel cap to dissolve following prosthesis insertion before proceeding with the rotation confirmation procedure. A voice prosthesis that does not rotate freely suggests that the rear flange has not unfurled and seated within the esophageal lumen. Assessment of the position of the rear flange of the prosthesis is recommended for direct confirmation/assessment.  
         [0045]    Removal of the Indwelling Low Pressure Voice Prosthesis should only be done by grasping the outer rim of the device securely with a hemostat. Pull gently and firmly until the prosthesis is fully withdrawn. Insert a 22 French dilator and tape it into position for five minutes prior to inserting a new Indwelling Low Pressure Voice Prosthesis that has been attached to an inserter. Never remove one voice prosthesis and reinsert another voice prosthesis without first dilating the trachea-esophageal puncture with the 22 French dilator. Always use a gel cap on the tip of an Indwelling Low Pressure Voice Prosthesis to enable easy, atraumatic insertion.  
         [0046]    The Indwelling Voice Prosthesis may be left in place in the trachea-esophageal puncture until it ceases to function correctly, that is, until it leaks or is not providing adequate voice for speech. If the prosthesis is not functioning properly, the patient should return to the clinician for evaluation.  
         [0047]    The Blom-Singer Flushing Pipet provides a means for flushing small particulate matter from the lumen and valve member of the Blom-Singer Indwelling Low Pressure Voice Prosthesis while in-situ, i.e., in the user&#39;s trachea-esophageal puncture. The following instructions should be made clear to the patient as part of the routine care of the Blom-Singer Indwelling Low Pressure Voice Prosthesis.  
         [0048]    The patient should illuminate the tracheostoma with a bright light source such that the open end of the voice prosthesis is clearly visible. Use long handled forceps (tweezers) to carefully remove any dried debris (phlegm) that may be in the open end of the voice prosthesis.  
         [0049]    Fill approximately one third of the stem of the pipet with clean water. Carefully and gently insert the tip of the pipet into the voice prosthesis only until it abuts against the stopper on the stem of the pipet. Briskly squeeze the bulb on the pipet to flush a rapid squirt of water through the voice prosthesis. If liquid will not readily squirt through the voice prosthesis, this indicates that it may be plugged with dried phlegm. Allow a few drops of water to dissolve this dried matter for a few minutes and then re-flush with the pipet until the debris breaks free. The debris must be removed from the trachea-esophageal puncture with a hemostat by the clinician for -thorough cleaning. Never attempt to reinsert an Indwelling Low Pressure Voice Prosthesis that has the strap removed.  
         [0050]    After flushing, remove the pipet carefully to avoid dislodging the voice prosthesis. Inspect the interior of the voice prosthesis with a bright light. Repeat flushing as needed.  
         [0051]    If the voice prosthesis is accidentally dislodged from the puncture, the patient should be instructed to immediately place a 22 French dilator in the puncture to keep the puncture from closing. The patient should then return to his/her clinician for re-insertion of the voice prosthesis.  
         [0052]    It is to be realized that only preferred embodiments of the invention have been described and that numerous substitutions, modifications and alterations are permissible without departing from the spirit and scope of the invention as defined in the following claims.