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PAS - Prosthetic Anal Sphincter
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The PAS Prosthetic Anal Sphincter device has been designed and developed over a period of 10 years to manage the condition of faecal incontinence based on studies of the normal function of the anal sphincter and pelvic floor.

The PAS device is designed for the management of severe faecal incontinence in adult men and women, and aims to overcome the risk of ischaemic complications by simulating the normal physiology of the ano-rectum and reproducing the action of the puborectalis muscle by flattening and angulating the bowel without causing crenation.

Prosthetic Anal Sphincter
  12.7Mb Surgical Technique Video


The PAS design comprises of 3 main components and is based on the present understanding of the dynamics of flow of solids and semi-solids.

Sphincter Cuff

  • Is available in one size only.
  • Comprises of an all-in-one design of a textured silicone cohesive gel-filled soft pillow that is attached by silicone elastomer straps to an inflatable linear expander, which when inflated, gently flattens the bowel against the silicone cohesive gel-filled pillow.
  • Is surgically positioned around the anal canal / lower rectum in order to achieve angulation.
  • When the inflatable linear expander is inflated, angulation is achieved and continence is
    effected.

Pressure Regulating Reservoir Balloon

  • Is provided in one size only
  • Provides the hydraulic pressure source to drive the system and has a sigmoid pressure-volume relationship.
  • Is set to operate at the pressure plateau level and maintains a near constant maximum pressure, irrespective of inflation volume.
  • Is implanted within the pelvis and ensures that excessive pressures do not develop in the system.

Control Pump

  • Comprises of silicone elastomer mouldings with stainless steel springs and valve components.
  • Allows movement of fluid to and from the sphincter, to open (deactivate) or close (activate) the device.
  • Implanted in a subcutaneous pocket in the abdominal wall.
  • Consists of 3 sub-components:

    The pump bulb, which when squeezed, transfers fluid from the expander to the balloon reservoir to open the cuff.

    The main pump block which houses the valves and incorporates a resealable fill port that is designed for post surgical percutaneous "top-up" of the system, if necessary.

    The pump button which, when depressed, returns fluid from the balloon reservoir to the expander to close the cuff.

Colour-coded Tubing

  • Assists the surgeon to make the appropriate tubing connections.
  • White tubing connects the control pump to the sphincter cuff.
  • Clear tubing connects the control pump to the pressure regulating reservoir balloon.

Barrier Shell Technology

  • Restricts gel permeation through the Sphincter Cuff's silicone cohesive gel-filled soft pillow.

High performance silicones

  • Maximises strength and durability of the PAS components.

Strong seals

  • To maintain optimum mechanical characteristics.

High quality raw materials

  • Implant grade silicone raw materials from a fully certified source are used to create the silicone components of the PAS device.
  • Implantable grade steel tubing connectors from a fully certified source are supplied with PAS device.

Individual product inspection

  • QA tested through every manufacturing stage to ensure complete conformance of individual components and finished device.

PAS Prosthetic Anal Sphincter

  Product code   Description
       
  PAS DEVICE  
Complete PAS device supplied in a box containing a sterile kit consisting of the 3 components necessary for 1 implantation procedure:
- Sphincter Cuff
- Pressure Regulating Reservoir Balloon
- Control Pump
     
  PAS CUFF  
Sphincter Cuff assembly
     
  PAS PUMP  
Control Pump assembly
     
  PAS RES  
Pressure Regulating Reservoir Balloon assembly
       
  • The PAS device can be supplied either as a complete kit PAS DEVICE or in individual components PAS CUFF, PAS RES, PAS PUMP.
  • The PAS device and components are supplied sterile and individually packaged within an outer box.
Prosthetic Anal Sphincter Prosthetic Anal Sphincter Prosthetic Anal Sphincter Prosthetic Anal Sphincter

Protected by US Patent 5,593,443 European Patent 0575376 and other corresponding national Patents.

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