Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
  • A61B5/1535—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes comprising means for indicating vein or arterial entry
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/15003—Source of blood for venous or arterial blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
  • A61B5/150488—Details of construction of shaft

Definitions

• This invention relates to devices used to collect samples of blood from patients for subsequent laboratory testing and analysis.
• the most widely used structure consists essentially of three parts. Firstly, a double-ended needle having a threaded connector between its ends, and covers attached one to each end of the connector and containing one end of the needle. These covers retain the needles in a clinically clean condition and must be removed before connection to a holder. After removing the covers, one end of the needle is inserted through an opening at the end of the holder and the needle device threaded in place in the holder.
• the assembly is then used to insert the other end of a needle into a vein, and then the third element, an evacuated receptacle, is inserted into the holder where a bung in the end of the receptacle is pierced by the end of the needle in the holder to permit blood to pass through the needle into the receptacle. Because the receptacle is evacuated, blood is drawn through the needle to fill the receptacle after which the receptacle can be withdrawn from the holder and a further receptacle engaged over the needle to receive another blood sample.
• the third element an evacuated receptacle
• a receptacle for use with a needle and holder and containing a piston which is drawn away from the needle to inspire blood into the receptacle.
• the piston is withdrawn using an elastomeric element which stores energy so that the piston cannot be withdrawn suddenly thereby obviating sudden large pressure fluctuations in the needle and hence in the vein.
• Fig. 1 is a sectional side view of a preferred embodiment of a blood collection device according to the invention in an assembled condition ready for use;
• Fig. 2 is a view similar to Fig. 1 showing a combination needle and holder sub-assembly as it would be supplied for use in the device and prior to assembly;
• Fig. 3 is an end view of a receptacle used in the device
• Fig. 4 is a perspective view of part of the device and a tool used in the assembly drawn to a larger scale than that used for Figs. 1 and 2;
• Fig. 5 is a partial view similar to Fig.l illustrating an alternative embodiment of the device
• Fig. 6 is perspective view of a conventional needle and holder assembly with some modification and also showing an adaptor for use with this assembly;
• Fig. 7 is a view similar to Fig. 1 and showing part of an alternative embodiment of the invention.
• Fig. 8 is a view similar to Fig. 1 and illustrating yet another embodiment of the invention.
• FIG. 1 illustrates a preferred embodiment of the invention after assembly.
• This structure consists essentially of a double ended needle 10 which is attached to a collar 12 such that the needle projects inwardly beyond the collar to pierce a septum of a bung 14
• S UBSTITUTE SHEET associated with a receptacle 16.
• the collar 12 is a snap fit in the neck 22 of a holder 24 and the receptacle 16 is retained in the holder by an annular rib 26 on the receptacle which engages in a corresponding depression 28 at the mouth of the holder 24.
• Fig. 1 To use the structure shown in Fig. 1, it is supplied initially as two distinct parts. Reference is made to Fig. 2 to show one of these parts which it will be seen consists of the needle 10 and the collar 12 engaged within the holder 24 and sealed by removeable end covers 30, 32. It can be seen in Fig. 2 that the collar 12 extends axially into a skirt 34 which positions the needle 10 inside the holder 24. To engage the receptacle 16, the end cover 32 is removed by simply tearing it away from the holder and if necessary the end cover 30 can also be removed in this way. However, .this cover can simply be pierced by the needle and pushed out of the way as the parts are assembled.
• the needle can be inserted into a vein and a small opening 36 in the needle provides a visual
• the bung 14 and piston 18 As blood is available in the needle, it will find its way into a cavity 38 formed both by the bung 14 and piston 18.
• the cavity is sealed because the bung includes an annular lip 40 which is inter-engaged with an annular depression in the piston.
• the user On pulling the element 20, the user causes this inter-engagement to be disturbed and the piston to move towards the other end of the receptacle.
• the wall of the receptacle has a larger diameter where the piston is stored and upon moving the piston slightly it engages a reduced or working diameter by riding over an inclined step 42 on the inner wall of the receptacle.
• the piston then forms a seal with the inside wall of the receptacle as it travels from this point and can be stopped whenever that sufficient blood has been removed.
• An important aspect of the invention is the fact that when the user pulls the elastomeric element 20, energy is stored in this element so that the piston cannot be moved suddenly to cause an instantaneous pressure drop in the patient's vein. Further, by pulling out the element 20 slowly or in small increments, the blood will be drawn smoothly and without causing sudden large pressure variations in the vein. Consequently it is possible to draw blood without collapsing the vein or causing impact and turbulence when the blood enters the receptacle.
• the wall of the receptacle 16 can be graduated if required and the user would simply pull out the element 20 until the blood meets the chosen graduation on the outside of the receptacle. The desired volume of blood is then contained in the receptacle.
• the user can remove this receptacle from the holder 24 without dislodging the needle from the patient and then enter a further receptacle if another sample is required.
• the element 20 is engaged through an opening at the end of the receptacle as previously mentioned. This opening is illustrated at 44 in Fig. 3.
• the opening is quite narrow so that it grips the elastomeric element 20 to permit storage of energy in the element by withdrawing the element faster than the piston moves. This in effect allows quite a simple procedure because the person operating the device does not have to continually pull the element because of the storage of energy.
• the element as mentioned can be pulled to a predetermined position or alternatively simply pulled a suitable amount and the piston allowed to catch up before pulling it further.
• the peg 48 is proportioned to pass through a slotted opening 52 formed in the elastomeric element which, as it can be seen in Fig. 4, is shaped in a complementary fashion in relation to the tool for engagement with the tool so that it can be withdrawn along with this part of the tool through the opening 44 in the receptacle.
• Suitable jigs would of course be used to ensure engagement and it is envisaged that an end load would be provided on the element 20 to deform the end so that the opening widens for engagement of the tool.
• FIG. 5 An alternative embodiment of holder is shown in Fig. 5.
• the neck 56 of this holder is proportioned to receive the needle and does not take part in locking the needle and associated collar 58 to the holder.
• This one or more dimples 60 are provided on the inside wall of the holder so
• Fig.6 There are currently in the marketplace a large number of holders used in association with prior art devices. In order to make use of these holders, there are two simple modifications which can be made, either one of which will permit the present receptacle to be used with the holder. Both of these modifications are incorporated into Fig. 6 where it will be seen that two large openings 64 have been cut in the wall of the holder and this permits the user to grip the receptacle after it has been engaged in the holder and thereby hold it in place during removal of blood.
• An alternative approach is to provide a collar 66 having upstanding latches 68 for engagement over an existing flange 70 at the flats on the flange.
• the collar includes inwardly formed ribs or projections 72 so that when in position these will allow the rib 26 (Fig. 1) to pass but will contain the receptacle by engagement with this rib.
• a bung 74 combines with a filmic cover 76 to define a cavity 78 which, like the cavity 38 in Fig. 1 can retain a liquid which is added to the blood automatically to facilitate various tests conducted in the laboratory.
• the piston is not interlocked with the bung. After removal of the blood, the needle would be disengaged and because the cover 76 is penetrated, the liquid would fall out into the blood and mix as required.
• the liquid used in the testing would be preassembled between the piston and the bung and a complete receptacle would be designated for use in accordance with the material contained between the bung and the piston.
• the Fig. 7 embodiment requires only that the bung and its contents be stored leaving the remainder of the receptacle including the piston for use with any particular type of bung and liquid contained in the bung.
• the materials used in the manufacture of the various embodiments can be any synthetic plastic material having suitable characteristics conventional in the art.
• the bung 14, the piston 18 and the tail 20 comprise a flexible urethane, although they may alternatively be made of anysuitable elastomeric material or rubber, and the holder 24, and collar 12 are made of polypropylene, although they may also alternatively be made of any other suitable inert material.
• Fig. 8 illustrates another embodiment of the invention. Parts corresponding generally to those described with reference to Fig. 1 have been given primed numerals to simplify comparison. It will be seen that a receptacle 16' contained in a holder 24' associated with a needle 10'.
• the holder 24' has a forward boss 80 which is threaded to receive a needle holder 82 having the needle 10' embedded in the holder and projecting inwardly of the holder 24'.
• This is a conventional needle assembly and is adapted into this holder to demonstrate that such a needle assembly can be used with the present invention.
• the needle holder 82 is adapted into this holder to demonstrate that such a needle assembly can be used with the present invention.
• SUBSTITUTE SHEET Oi FI , V ⁇ . lvi'o holder differs from prior art holders in that it combines with the receptacle 16' to retain the receptacle in position using a very simple structure. It will be seen that the wall of the receptacle 24' (as drawn at the top of the view) has a central annular portion 84 which is thinner at the bottom of the section as drawn than at the top. This thinner wall represents an area of reduced thickness and is associated with an internal ridge 86.
• the wall is thin in this portion, it can deflected inwardly to bring the ridge into a position where it abuts an annular shoulder 88 on the receptacle 16' to prevent removal of the receptacle while this deflection occurs.
• piston 18' has a different form from previous pistons described with reference to the other drawings.
• the form of this piston is particularly appropriate for this structure because it lends itself to inter-engagement with the bung 14 ' and as soon as it separates from the bung, the outer portion of the piston can deflect and the reactive force ensures a seal with the inner wall of the receptacle once the piston has passed the step 42'.

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• Vascular Medicine (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Applications Claiming Priority (2)

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• 1982
  • 1982-06-01 EP EP82902045A patent/EP0079941A1/de not_active Withdrawn
  • 1982-06-01 WO PCT/US1982/000754 patent/WO1982004387A1/en not_active Application Discontinuation

Non-Patent Citations (1)

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