Method and apparatus for obtaining blood for diagnostic tests

An assembly capable of providing an opening in an area of skin of a patient by means of lancet, comprising:

• (a) a holder for holding a lancet assembly;
• (b) a means for providing sufficient force to cause said holder to be maintained in a position whereby a lancet in said holder would be positioned away from said skin of said patient;
• and
• (c) a means for allowing a gas to provide sufficient force to overcome the force provided by said holder maintaining means, whereby said gas causes said holder to be moved to a position whereby a lancet in said holder would be able to pierce said skin of said patient, wherein said holder maintaining means (b) is a piston biasing means, wherein said piston biasing means is a bellows.

An assembly capable of providing an opening in an area of skin of a patient by means of lancet, comprising:

• (a) a holder for holding a lancet assembly;
• (b) a means for providing sufficient force to cause said holder to be maintained in a position whereby a lancet in said holder would be positioned away from said skin of said patient;
• and
• (c) a means for allowing a gas to provide sufficient force to overcome the force provided by said holder maintaining means, whereby said gas causes said holder to be moved to a position whereby a lancet in said holder would be able to pierce said skin of said patient, wherein said means (c) comprises a piston attached to said holder, said piston being disposed in a bore, said bore being capable of being opened to allow sufficient gas at sufficient pressure to enter to move said piston, whereby said holder is moved to said position whereby a lancet in said holder would be able to pierce said skin of said patient, wherein said means (c) further comprises a valve having a first port, a second port, and a third port, said first port capable of communicating with a source of gas at a first pressure, said second port capable of communicating with said bore, said third port capable of communicating with a source of gas at a second pressure, said second pressure being lower than said first pressure.

An assembly capable of providing an opening in an area of skin of a patient by means of lancet, comprising:

• (a) a holder for holding a lancet assembly;
• (b) a means for providing sufficient force to cause said holder to be maintained in a position whereby a lancet in said holder would be positioned away from said skin of said patient;
• and
• (c) a means for allowing a gas to provide sufficient force to overcome the force provided by said holder maintaining means, whereby said gas causes said holder to be moved to a position whereby a lancet in said holder would be able to pierce said skin of said patient, wherein said means (c) comprises a piston attached to said holder, said piston being disposed in a bore, said bore being capable of being opened to allow sufficient gas at sufficient pressure to enter to move said piston, whereby said holder is moved to said position whereby a lancet in said holder would be able to pierce said skin of said patient, said assembly further including a means for sealing said bore, wherein said sealing means is a bellows.

An assembly capable of providing an opening in an area of skin of a patient by means of lancet, comprising:

• (a) a holder for holding a lancet assembly;
• (b) a means for providing sufficient force to cause said holder to be maintained in a position whereby a lancet in said holder would be positioned away from said skin of said patient;
• and
• (c) a means for allowing a gas to provide sufficient force to overcome the force provided by said holder maintaining means, whereby said gas causes said holder to be moved to a position whereby a lancet in said holder would be able to pierce said skin of said patient, wherein said means (c) comprises a piston attached to said holder, said piston being disposed in a bore, said bore being capable of being opened to allow sufficient gas at sufficient pressure to enter to move said piston, whereby said holder is moved to said position whereby a lancet in said holder would be able to pierce said skin of said patient, said assembly further including a means for sealing said bore, wherein said sealing means is a diaphragm.

An assembly capable of holding a lancet assembly for providing an opening in skin of a patient, comprising:

• (a) a housing having
• a bore having an axis;
• a valve fitted in a valve manifold;
• a first port in said valve manifold that allows said valve manifold to allow passage of gas at a first pressure through
• a first port in said valve;
• a second port in said valve manifold that allows said valve manifold to allow passage of said gas at said first pressure through a second port in said valve to enter said bore;
• a third port in said valve manifold that allows said valve manifold to allow passage of gas from said bore through a third port in said valve to a location having gas at a second pressure, said first pressure being greater than said second pressure;
• (b) a piston disposed in said bore, said piston having a proximal end and a distal end, said proximal end adjacent to said second port and said distal end including a holder for holding a lancet, said piston capable of moving along the axis of said bore;
• (c) means for biasing said piston so that said proximal end of said piston is in the furthest position away from the skin of said patient when said first port is closed.

A method for forming an opening in an area of skin of a patient in order to obtain blood, said method comprising the steps of:

• (1) providing a lancing assembly capable of providing an opening in an area of skin of a patient by means of lancet, comprising:
• (a) a holder for holding a lancet assembly;
• (b) a means for providing sufficient force to cause said holder to be maintained in a position whereby a lancet in said holder would be positioned away from said skin of said patient;
• (c) a means for allowing a gas to provide sufficient force to overcome the force provided by said holder maintaining means, whereby said gas causes said holder to be moved to a position whereby a lancet in said holder would be able to pierce said skin of said patient;
• (d) a means for reducing level of pressure in said area of said skin of said patient below 0 psig;
• and
• (e) a lancing assembly in said holder,
• (2) positioning said lancing assembly sufficiently close to said skin of said patient so that a lancet in said lancet assembly can pierce said skin of said patient;
• (3) reducing level of pressure in said area of said skin of said patient below 0 psig;
• and
• (4) causing said means (c) to allow a gas to provide sufficient force to overcome the force provided by said holder maintaining means, so that said holder is moved to a position whereby said lancet in said lancet assembly pierces said skin of said patient;
• and
• (5) causing said lancet to be retracted from said skin of said patient.