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Voice Prostheses and Accessories

voice prosthesis (plural prostheses) is an artificial device, usually made of silicone that is used to help laryngectomized patients to speak. During a total laryngectomy, the entire voice box (larynx) is removed and the windpipe (trachea) and food pipe (esophagus) are separated from each other. During this operation an opening between the food pipe and the windpipe can be created (primary puncture). This opening can also be created at a later time (secondary puncture). This opening is called a tracheoesophageal puncture (TE puncture). The voice prosthesis is placed in this opening. Then, it becomes possible to speak by occluding the stoma and blowing the air from the lungs through the inside of the voice prosthesis and through the throat, creating a voice sound, which is called tracheo-esophageal speech. The back end of the prosthesis sits at the food pipe. To avoid food, drinks, or saliva from coming through the prosthesis and into the lungs, the prosthesis has a small flap at the back. There are two ways of inserting the voice prosthesis: Through the mouth and throat (retrograde manner) with the help of a guide wire or directly through the tracheostoma (anterograde) manner. Nowadays, most voice prosthesis are placed anterograde through the stoma.


Provox 1 Voice Prosthesis

Provox 1 Voice Prosthesis
Provox 1 Voice Prosthesis

The original Provox 1 Voice Prosthesis was released in 1990 to provide an advanced indwelling prosthesis with low airflow resistance and extended device lifetime for tracheoesophageal voice restoration. The voice prosthesis is supplied with a Provox® Guidewire for retrograde insertion.

 

ORDER INFORMATION 

SIZE 

RX

REF

Provox 1

4.5 mm

Rx

7208

Provox 1

6 mm

Rx

7200

Provox 1

8 mm

Rx

7201

Provox 1

10 mm

Rx

7202

 

Provox 2 Voice Prosthesis

Provox 2 Voice Prosthesis
Provox 2 Voice Prosthesis

The second generation Provox prosthesis (Provox2) was introduced in 1997. Provox2 is a low resistance, indwelling silicone voice prosthesis that can be inserted:

 

  • Immediately after primary or secondary TE puncture, without the need for temporary stenting. This retrograde insertion is to be performed by a physician using the Provox® Guidewire.
  • As a replacement prosthesis for the Provox (1) or other voice prostheses.
  • In an anterograde manner using the single-use insertion tool. This preferred method can be performed by trained health care professional. 

 

Order information

Size

RX

REF

Provox 2

4.5 mm

Rx

7216

Provox 2

6 mm

Rx

7217

Provox 2

8 mm

Rx

7218

Provox 2

10 mm

Rx

7219

Provox 2

12.5 mm

Rx

7221

Provox 2

15 mm

Rx

7224

Provox Acti Valve

Provox Acti Valve is designed for those who experience short prosthesis lifetime (less than 4 - 8 weeks) caused by early leakage through the prosthesis or negative pressure in the pharynx esophagus during swallowing or inhalation. The valve and valve-seat of the Provox Acti Valve contain magnets that prevent inadvertent opening.

 

Benefits:


  • Reduces the need for frequent replacements in a majority of users who experience short device lifetime.
  • Available in three opening forces: Light, Strong and XtraStrong. 

Provox Vega Puncture Set

Provox Vega Puncture Set
Provox Vega Puncture Set

Provox Vega Puncture Set is a new set for performing TE puncture and surgical placement of the Provox Vega voice prosthesis.


Features & Benefits:


  • All in one surgical puncture and placement
  • No additional instruments are normally required
  • Pre-loaded with a Provox Vega voice prosthesis
  • Disposable
  • Less force and less time needed, for the majority
  • Provided sterile
  • Minimum preparation and assembly
  • For primary and secondary TEP


Multicenter Study Results:


The Provox Vega Puncture Set allows immediate voice prosthesis insertion without requiring additional instruments. Integral placement of the Provox Vega voice prosthesis was successful in all procedures carried out during a multicenter clinical study. Only in 11% of the procedures the additional use of a hemostat was needed to pull the tracheal flange of the voice prosthesis in place. The largest part, 89% of the procedures required no additional instruments.

Provox Guidewire

The Provox Guidewire enables retrograde insertion of Provox (1) and Provox (2) prostheses. The tip contains a retainer slit into which the security string of the prosthesis is held. There is also a stop on the guidewire shaft to allow extraction of the old prosthesis (after the tracheal flange has been cut off). The guidewire is not intended for pulling the prosthesis into the TE-fistula a non-toothed hemostatic forceps is recommended for this procedure.

Provox Lary Tube

Provox LaryTube is a very popular soft laryngectomy tube. A key feature that distinguishes the Provox LaryTube from traditional laryngectomy tubes is that it can hold a Provox HME cassette and/or Provox Free Hands HME. It is available in three versions and can be used with or without voice prosthesis.


Benefits:

  • Allows for immediate post-operative use of an HME.
  • No adhesive required which means that you can use the LaryTube even with sensitive skin or during the radiotherapy period.
  • Helps laryngectomees with an unstable or deep stoma to achieve pulmonary protection and rehabilitation.
  • Maintains an open stoma in patients with shrinking stomas.

Provox Lary Button

The Provox LaryButton™ is a soft, self retaining silicone stoma button. It maintains an open tracheostoma and is intended to be worn in combination with a Provox HME cassette or Provox FreeHands HME.


Benefits:

  • The conical shape facilitates a secure fit.
  • Constructed from soft silicone material and atraumatically shaped to reduce negative side-effects such as stoma irritation and bleeding.

Provox HME Cassettes

The Provox HME Cassette, the 24/7 HME, is the core of Atos Medical’s product line for effective pulmonary rehabilitation following a total laryngectomy. The provox family of HMEs continues to grow with the addition of the next generation of HME cassettes is the Provox XtraHME. Now with even better humidification from which many patients breathing through a tracheostoma will benefit.


Improved Features:


Welcome two new family members:

  • XtraMoist HME™ comes even closer to mimicking normal nasal function. Humidification is improved and good airflow is maintained for easy breathing. XtraMoist is recommended for patients who have recently undergone a total laryngectomy, and for those already accustomed to using an HME.
  • XtraFlow HME™ delivers superior airflow. XtraFlow is great to use when exercising, adapting to using an HME, and for those that prefer lower resistance breathing.


Other Family Members:


  • HiFlow traditional lower resistance breathing for physical activity and acclimating to HME resistance initially.
  • Normal traditional standard resistance breathing closer to normal upper airway resistance.

 

Features:

  • Heat and moisture exchanger (HME)
  • Facilitates manual stoma occlusion, thereby improving speech as well as hygiene
  • Beneficial side openings that enable airtight closure of  the stoma even when the HME is covered by clothing,

 

Which means that:

  • The HME can be discreetly hidden
  • There will be less wet stains on the clothing

Provox Adhesives

Provox® Adhesive base plates are designed to hold the Provox® HME Cassette, Provox® Free Hands HME, and Provox® Shower Aid in front of the tracheostoma, and to provide an optimized seal to the skin around the stoma.

 

There are four different types of adhesives, with three different adhesive properties and two different shapes (oval and round).

 

  • FlexiDerm™ often preferred for its strong, flexible adhesive properties (mean durability- 2 days)
  • OptiDerm™ a hydrocolloid material, so skin-friendly that it can even be used the day after surgery and even by laryngectomees with temporary or chronic skin sensitivity (mean durability: 2 days)
  • Regular a standard adhesive with normal adhesive properties, easy to remove (mean durability: 1 day).
  • XtraBase™ a unique, convex self-adhering base plate. The adhesion properties of the popular FlexiDerm base plate and Provox XtraBase are alike. But thanks to its special shape and reinforced center, it is also ideal for persons with a deep stoma or anyone using an automatic tracheostoma valve such as the Provox FreeHands HME. 

Kapi-Gel Tracheostoma Sizer

Kapi-Gel Tracheostoma Sizer
Kapi-Gel Tracheostoma Sizer

Kapi Gel® Tracheostoma Sizer is a 43 mm diameter, 5 mm thick circular, tacky, laminated silicone gel spacer available in two center hole openings to accommodate different diameter tubes and Buttons. (8 mm opening fits tubes or buttons with <14 mm OD, 12 mm opening fits tubes or buttons with >12 mm OD).

 

Kapi-Gel spacers are intended to help create a better seal around tracheostoma support devices and is suitable for uneven stoma anatomy. Kapi-Gel can improve tracheostoma device fitting, act as a cushion behind tubes and buttons during digital occlusion, and may help reduce air leakage.

Provox Free Hands HME

The Provox Free Hands HME is best used with a Provox Xtra Base self adhering base plate but it can also be attached to any other Provox Adhesive base plate or a Provox LaryTube cannula with ring (which itself is held by a base plate). All features of the Provox Free Hands HME are designed for maximum discretion i.e. the small size, the transparent color and the side openings (which allow the device to be covered with clothing). If needed, by simply rotating the Provox Free Hands HME while in place, a user can turn the automatic speech function on or off. To match individual needs, the Provox Free Hands HME is available with three easyto-replace membranes each with different closing resistances.

 

The clinician should adjust the device for the user by choosing a suitable membrane and checking the proper function of the adjustable cough-relief valve. A dedicated cleaning container facilitates the maintenance of the reusable valve unit. The FreeHands HME cassettes are specially designed to fit the FreeHands valve unit (housing) or the HME Cap and are different from the regular HME cassettes.

Provox Shower Aid

The Provox Shower Aid is used with Provox Adhesives (Flexiderm or Regular). Used as a temporary replacement for a Provox HME Cassette while taking a shower.

Provox Dilator

The Provox Dilator is designed to facilitate replacement and insertion of the Provox NiDprosthesis. It serves to keep the fistula tract open after removal of and/or prior to the insertion of the Provox NiD. Also, a small circular ridge helps to keep the Provox Dilator in place and reduces the tendency of it sliding out. Included in the Starter Kit and available separately.

Provox Brush

The Provox Brush design is based on our long experience with indwelling Provox prostheses,and is a valuable maintenance tool for in-situ and ex-situ cleaning. Included in the Starter Kit and available separately.

Provox Flush

The Provox Flush is a dedicated maintenance device for cleaning the inner lumen of the Provox NiD prosthesis by using clean water or air. Included in the Starter Kit and available separately.

Provox Trocar With Cannula

Provox Trocar With Cannula
Provox Trocar With Cannula

This instrument is used for making primary or secondary TE punctures. The Provox Trocar With Cannula is preferred to a scalpel because it creates a round fistula and the surrounding tissue remains intact. After the trocar is withdrawn, the Provox Guide wire is inserted through the cannula.

Provox Pharynx Protector

Provox Pharynx Protector
Provox Pharynx Protector

The Provox Pharynx Protector helps protect the pharyngeal walls from accidental piercing during primary TE puncture. It can also reduce the risk of injury to the surgeon.

Provox Measure

The Provox Measure is used to check the length (corresponding to prosthesis size) of TE fistulas. The correct prosthesis size is important to minimize the risk of complications and should always be checked when replacing a prosthesis. The single use flanges of Provox Measure can be attached to the instrument in two different ways, facilitating measurement of fistulas made for different voice prosthesis diameters.

Silicone Block

A flexible vulcanized silicone elastomer material designed for implant or reconstruct to augment cartilaginous tissue and bone loss.



Benefits & Advantages:


  • Easy to cut to required size and shape using knife or scissors.
  • Allows the physician to create custom implant configurations.
  • Easy explantation with minimal trauma. 
  • Storage of unused portion in resealable poly bag.

 

Applications useful in the fabrication of:

 

  • Custom surgical implant for trauma injuries.
  • Surgical implant to augment cartilage or damaged bone.
  • Chin prostheses. 
  • Malar prostheses.

 


Cleaning:

 
Scrub in solution of hot soapy water to remove possible surface contaminants. Use a non-oily cleaner or mild soap. DO NOT USE synthetic detergents or oil based soaps, as these may leach out to cause a tissue reaction. Rinse in hot water and follow with a thorough rinse in distilled water.


Sterilize:
 


Must be autoclaved. Autoclave by High Speed Instrument (Flash) Sterilizer in clean open tray. Sterilize for eight (8) minutes at 270F (130 C), 30 psi.

 

Do not gas sterilize. do not Resterilize.

Provox Silicone Glue

Provox Silicone Glue is a liquid glue for skin application that cures on contact with the air. Long term use may cause skin irritation and does not work for everybody. The use of Skin Prep before application of silicone glue is normally recommended.


BVM Meditech Private Limited

Mr. Alok Vashistha / Vivek Vashistha (Director)
No. 306, 3rd Floor, Local Shopping Complex, Pocket-B & E, Mantri Arcade, Dilshad Garden
New Delhi - 110095
Delhi, India
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