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PERTHESE® T.E.

Percutaneous Tissue Expanders
The PERTHESE® T.E. percutaneous Tissue Expander is designed for use in the development of tissue flaps for reconstrunction of tissue defects and definciencies. The device is placed subcutaneously or submuscularly and inflated periodically with sterile isotonic saline until a sufficient amount of tissue is developed.
TRI-LAMINATED ENVELOPE Three layers of pure medical grade silicone, limiting gel migration to a minimum.

Well suited for:

  • Post mastectomy reconstruction
  • Correction of an underdeveloped breast
  • Treatment of scare revision
  • Tattoo removal
  • Provision of tissue with caracteristics similar to donor tissue, e.g., color, texture, hair density
  • Reconstruction of donor site defects
  • Creation of a "delayed flap", e.g. extended delto-pectoral flap.

The PERTHESE®T.E. Percutaneous tissue expander is provided sterile in various shapes and sizes. Optional tubing location, reinforced base and custom-made tissue expanders available upon request. For complete custom-made product information, contact your local distributor. The PERTHESE®T.E. Percutaneous tissue expander is fabricatedform a high performance silicone envelope. The product is available with a self-sealing remote valve. The remote valve tubing length may be shortened at the doctor´s discretion with the aid of the Metal Tubing Connector.

The remote valve consists of an injection port constructed of self-sealing material with a dome to aid in palpation. An important safety feature in all of the valves is the inclusion of a stainless steel needle stop, which help to prevent inadvertent perforation through the valve.

Rectangular with remote accessory valve-style 90

  • Designed for planar flap advancement.
  • Best suited for indications on the extremities and the trunk
                 
Cat. No Vol. cc* Width, cm*(A) Length, cm* (B) Projection
cm* (C)		 Tubing Length, cm* (L)    
90-0025 25 2,0 6,5 2,0 10,0    
90-0050 50 3,0 7,0 3,0 10,0    
90-0100 100 4,0 9,0 3,0 10,0    
90-0160 160 5,0 12,0 3,0 15,0    
90-0320 320 6,0 16,0 4,0 15,0    
90-0480 480 7,0 16,0 5,0 15,0    
90-0640 640 8,0 19,0 5,0 15,0    
90-1000 1000 8,0 20,0 7,0 15,0    
                 

Round with remote accessory valve-style 91
  • Designed for the creation of an hemispheric flap.
  • Best suited for indications on the skull and for round lesions
Cat. No Vol. cc* Diameter*
cm(A)		 Projection
cm* (C)		 Tubing* Length, cm (L)    
91-0030 30 5,0 2,5 10,0    
91-0050 50 6,0 3,0 10,0    
91-0100 100 8,0 4,0 10,0    
91-0200 200 8,0 5,0 15,0    
91-0300 300 10,0 6,0 15,0    
91-0400 400 11,0 6,0 15,0    
91-0500 500 12,0 6,0 15,0    
91-0600 600 13,0 7,0 15,0    
91-0700 700 14,0 8,0 15,0    
"Kidney Shape" with remote accessory
valve-style 92 and internal silicone reinforced base
- Designed to produce flaps matching the defect contours. Maximize patient while minimizing patient scarring.
- Low profile design allows easier insertion into the surgical pocket and avoids excess envelope material folds for case of filling without shell wrinkling.
- Inflation bag with an internal silicone reinforced base to ensure forward expansion.
Cat. No Vol. cc* Width, cm*(A) Length, cm* (B) Projection
cm* (C)		 Tubing
Length, cm*(L)		      
92-0050 50 3,5 8,0 2,0 10,0      
92-0140 140 6,0 10,0 3,0 10,0      
92-0180 180 4,0 13,0 3,0 15,0      
92-0360 360 5,2 13,5 6,0 15,0      
92-0480 480 8,0 16,0 6,0 15,0      
                 
Tear drop with remote accessory valve-style 93
Cat. No Vol. cc* Width, cm*(A) Length, cm* (B) Projection
cm* (C)		 Tubing
Length, cm*(L)		      
93-0200 200 7,0 11,0 5,0 15,0      
92-0300 300 9,0 12,0 5,0 15,0      
92-0400 400 11,0 13,0 6,0 15,0      
92-0600 600 12,0 16,0 6,0 15,0      
                 
Coissant with remote accessory
valve-style 94 and internal silicone reinforced base
- Maximize patient flaps while minimizing patient scarring.
- Maximum expansion of the flap occurs over the middle of the expander. The expander allows for improved flap generation and advancement on both flat and curved body surface.
- Inflation bag with an internal silicone reinforced base to ensure forward expansion.
Cat. No Vol. cc* Outer
Width, cm*(A1)		 Inner Width, cm*(A2) Outer
Depth
cm*(B1)		 Inner
Depth
cm*(B2)		 Projection
cm* (C)		 Hemis-pheric cm*(D) Tubing
Length, cm*(L)
94-0050 50 7,0 4,0 5,0 3,0 4,0 8,0 10,0
94-0125 125 10,0 7,0 7,0 4,5 5,0 12,0 10,0
94-0250 250 13,0 9,0 10,0 6,0 6,0 15,0 15,0
94-0500 500 17,0 12,0 12,0 8,0 8,0 18,0 15,0
94-0700 700 19,0 13,0 15,0 9,0 8,0 20,0 15,0
                 
General Informations
Material Used
All Perthese®T.E. are manufacturedusing High Performance Medical Grade Elastomer which presents greater tear propagation than conventional silicone Elastomer.
Each Set Contains

- One inflatable envelope with an attached remote valve.
------>standard size for expanders superior to 100 cc,
------>small size for expanders up to 100 cc.
- A metal tubing connector.
(The metal tubing connector allows for variable tubing
length between the tissue expander and remote valve)

Standard Packaging

  • The sterile implant is contained in a film wrap and enclosed in a double pouch to provide maximum sterility assutance.
  • Separate sterile packaging for the metal tubing connector
  • Supplied with patient labels.
  • Protective outer-container

Refer to the product insert provided in the package for indications, contraindications, precautions andwarnings, possible adverse reactions, complications and instructions for use.
 

Contraindications

The Perthese®T.E. Percutaneous Tissue Expander may not be well tolerated in any patient who:

  • Has a history of sensitivity to foreign objects or has extreme allergies,
  • Has localized acute infection,
  • Exhibits certain types of psychological instability, e.g., does not want implants, displays a lack of understanding, or inappropriate motivation or attutude
  • Exhibits inaadequate or unsuitable tissues, e.g., radiation damageto tissue, ulceration, poorly vascularized tissue,
  • Exhibits physiological or anatomical anomalies that might result in post operative complications, e.g., bleeding diathesis or decreased resistance to infection,
  • Has a history of repeated cancer which has metastasized.

    These are general, relative contraindications and each individual patient must be evaluated by his/her sugeon to determine the specific risk/benefit ratio.
 

WARRANTY

LPI warrants that reasonable care in selection of materials and methods of manufacture were used in fabrication of these products. LPI shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of these products. The foregoing warranties, as conditioned and limited, are in lieu of and exclude all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise. LPI neither assumes nor authorizes any other person to assume for it any other or additional liabily or responsibility in connection with these products. LPI intends that these products should be used only by physicians having appropriate training in plastic and reconstructive surgery techniques.
 

Warning
As slight variations in size can occur with these products, not all Tissue Expanders will have the exact measurements indicated. Measurements are obtained by placing the filled unit (with suggested volume of saline fill) on a flat suface.

PERTHESE® is a registered Trademark of LABORATOIRE PEROUSE IMPLANT. Made in France by LABORATOIRE PEROUSE IMPLANT.

© Höjmed AB – 2006

info@hojmed.com