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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.
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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.
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Sphincter Cuff
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Is available in one size only.
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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.
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Is surgically positioned around
the anal canal / lower rectum in
order to achieve angulation.
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When the inflatable linear
expander is inflated, angulation
is achieved and continence is
effected.
Pressure Regulating Reservoir Balloon
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Is provided in one size only
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Provides the hydraulic pressure
source to drive the system and
has a sigmoid pressure-volume
relationship.
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Is set to operate at the pressure
plateau level and maintains a near
constant maximum pressure,
irrespective of inflation volume.
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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
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Assists the surgeon to make the
appropriate tubing connections.
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White tubing connects the control
pump to the sphincter cuff.
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Clear tubing connects the control
pump to the pressure regulating
reservoir balloon.
High performance
silicones
High quality raw
materials
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Implant grade silicone raw
materials from a fully certified
source are used to create the
silicone components of the PAS
device.
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Implantable grade steel tubing
connectors from a fully certified
source are supplied with PAS
device.
Individual product
inspection
PAS Prosthetic Anal Sphincter
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Product code |
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Description |
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PAS DEVICE |
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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 |
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PAS CUFF |
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Sphincter Cuff assembly |
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PAS PUMP |
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Control Pump assembly |
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PAS RES |
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Pressure Regulating Reservoir Balloon
assembly |
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The PAS device can be supplied either as a complete kit PAS
DEVICE or in individual components PAS CUFF, PAS RES, PAS PUMP.
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The
PAS device and components are supplied sterile and
individually packaged within an outer box.
Protected by US Patent 5,593,443 European Patent 0575376 and other corresponding national Patents.
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