Sterile assembly for protecting and fastening an indwelling device

A sterile indwelling device assembly comprising:

• an indwelling device of predetermined length and diameter having a proximal end and a distal end;
• a tubular sheath of impervious, flexible, transparent plastic enclosing said device for substantially the full length thereof, said sheath having thin, limp walls, a proximal end with an elongated, bell shaped dome of self-supporting, plastic adhered thereon for sealing around an incision and a distal end sealed around the distal end of said device;
• clamp means including base flange means for affixation to the skin at a spaced distance from said incision and clamp jaw means of soft resilient material having a pair of clamp arms upstanding from said base flange means and an elongated, clamp slot located between said base flange means and said clamp jaw means;
• said slot receiving a length of said indwelling device, and the portion of said sheath enclosing said length, therewithin and clamping or unclamping the same against longitudinal movement therealong in response to application, or release of finger pressure on said upstanding clamp arms.

In combination:

• an indwelling device, such as an elongated electrode, or catheter, of predetermined length and predetermined, uniform outside diameter;
• a clamp for said device, said clamp comprising an elongated block of flexible, resilient material having a pair of longitudinally extending, laterally spaced apart, clamp arms upstanding therefrom and defining an elongated slot therebetween for receiving a length of said indwelling device, said clamp having an integral outwardly protruding flexible base flange for attachment thereof to the skin;
• and an elongated, protective, covering, tubular sheath of flexible, transparent impervious plastic having thin walls and substantially co-extensive in length with the length of sais indwelling device, said tubular sheath having an elongated bell shaped dome of self-supporting transparent plastic fixed at its proximal end for enclosing and sealing the area around an incision, said sheath being sleeved around said indwelling device throughout its length and being sealed at its distal end to the distal end of said device;
• said clamp slot being of predetermined diameter equal to, or less than, the outside diameter of said indwelling device plus the thickness of the wall of said tubular sheath, to normally lock said sheathed device against sliding in said slot except when pressure is exerted on said upstanding arms to open said slot for sliding of said device therealong.

The method of positioning an indwelling device relative to an incision in the skin of the human body, by means of a releasable clamp affixable to said skin, while maintaining sterility of said device, which comprises the steps of:

• entirely covering said indwelling device with a tubular sheath of flexible sterile, impervious transparent plastic from the area of said incision to proximate the end of said device;
• adhering the end of said sheath, at said incision, around said incision and sealing the other end thereof around said device to seal said device against contamination by air;
• then gripping a length of said device, and the corresponding length of said sheath encircling the same against longitudinal movement in said clamp;
• and
• then affixing said clamp to said skin at a selected spaced distance from said incision, to prevent longitudinal movement of said device.