CA1144026A - Blood collection device with anti-backflow means - Google Patents
Blood collection device with anti-backflow meansInfo
- Publication number
- CA1144026A CA1144026A CA000305848A CA305848A CA1144026A CA 1144026 A CA1144026 A CA 1144026A CA 000305848 A CA000305848 A CA 000305848A CA 305848 A CA305848 A CA 305848A CA 1144026 A CA1144026 A CA 1144026A
- Authority
- CA
- Canada
- Prior art keywords
- valve
- blood
- collection chamber
- needle
- chamber
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
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
- A61B5/154—Devices using pre-evacuated means
-
- 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
- A61B5/150221—Valves
-
- 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
-
- 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
- A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
Abstract
ABSTRACT OF THE DISCLOSURE
A blood collection tube is provided with a stopper adapted to be pierced by a needle cannula for introducing a sample of blood into the collection tube, and a valve disposed the tube which allows blood to flow from the proximal end of the needle into the blood collection chamber of the tube but prevents the reflux of blood from the collection chamber to the patient.
A blood collection tube is provided with a stopper adapted to be pierced by a needle cannula for introducing a sample of blood into the collection tube, and a valve disposed the tube which allows blood to flow from the proximal end of the needle into the blood collection chamber of the tube but prevents the reflux of blood from the collection chamber to the patient.
Description
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BLOOD COLLECTION DEVICE WITH ANTI-BACI~FLOW MEANS
B_ ~GROUND OF Tl-lE INVENT10;~1 This invention relates to fluid sanlpling devices and more particularly to blood collection containers for dral~ing blood samples.
Evacuatecl containers or tubes having needle pierceable stoppers are used extensively in drawing blood samples for the purpose of conducting labora~ory tests on the patient s blood. A conventiollal method of obtaining a sample is to employ a blood collection tube and a tube and needle holder having a double-ended needle cannula. After the distal end of the cannula is placed in the vein of the patient the air evacuated blood collection tube is moved in the holder with the tube stopper being guided onto the proximal end of the cannula. The cannula pierces the stopper and the negative pressure in the container facilitates the drawillg of blood ,rom the ~ein of the patient.
In many cases a number of evacuated containers are filled with blood ' samples while using the same tube holder and wllile the cannuld~relllains in theI vein of the patient. For example con-tainers provided with di-fferent chemicals may be used to draw a number of blood samples for the purpose of conclucting different clinical tests on the patient s blood. Care must be taken -to avoid 20 the flowoack of drawll blood to the patient since -these cheillicals n~ay be harmful to the patient Also non-sterile tubes are usually used.
When employing conventional tube and needle holciers and evacuated collection tubes faulty techniques in drawing blood can cause ~ithdrawn blood to be returnea to the patient For example if the contents of the ; tube is allowed to contact the proximal end of the needle and an employed tourniquet is not removed soon after blood be~ s to flow or if the arm of the patient is raised a drop in venous pressure nlay cause the flowback of blood from the tube to the patient. Also, if a force is applied to the tube in a manner to compress the stopper against the holder while the tube contains blood, a pumping effect may be produced causing withdrawn blood to flow back into the patient.
Valves have been provided in the needle assembly of sampling devices to prevent the backflow of drawn blood from the container or tube to the pa-tientO U.S. Patent No. 3,874,367, for example, shows a valve disposed in a chamber constructed in a needle assembly between distal and proximal needles for prevent-ing withdrawn blood from returning to the patient. This construct-ion, however, is relatively expensive not only because of the new tooling required in the manufac-ture of such needle assemblies bu-t because of the additional parts required. Such devices require two needles, two hubs, and the s-teps of securing each needle to its hub. Such parts and steps result in relatively high manufaeturing costs.
SUMMARY OF THE INVENTION
Aeeordingly, the present invention seeks to provide a fluid eolleetion deviee whieh prevents baekflow of fluid from the eolleetion chamber of the device to the source of the fluid and which is relatively economical and ean be employed with eonventional needle assemblies and tube holders.
Briefly, the present invention provides a eolleetion deviee that ineludes an evaeuated eontainer elosed at one end and having a needle-pierceable stopper elosing the opposite end.
A fluid flow one-way valve is disposed within the eontainer whieh allows fluid to flow from the needle to the eolleetion chamber but prevents fluid flow from the eollection chamber to the needle.
In one broad aspect, the invention comprehends a blood collection deviee which ineludes a eontainer having one end elosed and a blood eollee-tion ehamber for receiving a blood sample. A needle-piereeable stopper eloses the opposite end 40~6 of the con-tainer and is adapted to be pierced by a needle connected to a source of blood, the collection chamber normally having a negative pressure therein. A fluid pressure different-ial responsive one-way valve is disposed in the contalner between the stopper and the collection chamber in the path of blood flow from a needle piercing the stopper to the collection chamber and includes a pair of valve members relatively movable for opening and closing the valve. The valve is responsive to fluid pressure differentials thereacross such that the valve is open to allow blood flow from the needle through the valve -to the collection chamber when the fluid pressure on the needle side of the valve is greater than that on the collection chamber side thereof, but is otherwise normally closed to prevent the flow of blood from the collection chamber -through the valve to the needle. The valve members are normally sealingly engaged with each other to close the valve, one of the valve ~embers being movable relative to the other valve members to open the valve and allow blood flow from the needle to the collection chamber when in use, the other valve member belng a hollow member providing a valve chamber disposed to receive the tip of a needle piercing the stopper when in use and allowing the passage of blood therethrough to -the collectlon chamber. The onevalve member normally closes the valve chamber Erom the collection chamber, and -the valve includes means for normally urging the one valve member into sealing engagement with the other valve member.
.:
BRIEF DESCRIPTION OF THE DRAWINGS
-Figure 1 is a side elevation partly in section of a fluid collection device in accordance with a preferred embodiment of the present invention with the device shown disposed in a tube and needle holder;
Figure 2 is an enlarged elevational cross-sé~ti~n~1 view of the stopper and fluid pressure responsive~
, s~ "
BLOOD COLLECTION DEVICE WITH ANTI-BACI~FLOW MEANS
B_ ~GROUND OF Tl-lE INVENT10;~1 This invention relates to fluid sanlpling devices and more particularly to blood collection containers for dral~ing blood samples.
Evacuatecl containers or tubes having needle pierceable stoppers are used extensively in drawing blood samples for the purpose of conducting labora~ory tests on the patient s blood. A conventiollal method of obtaining a sample is to employ a blood collection tube and a tube and needle holder having a double-ended needle cannula. After the distal end of the cannula is placed in the vein of the patient the air evacuated blood collection tube is moved in the holder with the tube stopper being guided onto the proximal end of the cannula. The cannula pierces the stopper and the negative pressure in the container facilitates the drawillg of blood ,rom the ~ein of the patient.
In many cases a number of evacuated containers are filled with blood ' samples while using the same tube holder and wllile the cannuld~relllains in theI vein of the patient. For example con-tainers provided with di-fferent chemicals may be used to draw a number of blood samples for the purpose of conclucting different clinical tests on the patient s blood. Care must be taken -to avoid 20 the flowoack of drawll blood to the patient since -these cheillicals n~ay be harmful to the patient Also non-sterile tubes are usually used.
When employing conventional tube and needle holciers and evacuated collection tubes faulty techniques in drawing blood can cause ~ithdrawn blood to be returnea to the patient For example if the contents of the ; tube is allowed to contact the proximal end of the needle and an employed tourniquet is not removed soon after blood be~ s to flow or if the arm of the patient is raised a drop in venous pressure nlay cause the flowback of blood from the tube to the patient. Also, if a force is applied to the tube in a manner to compress the stopper against the holder while the tube contains blood, a pumping effect may be produced causing withdrawn blood to flow back into the patient.
Valves have been provided in the needle assembly of sampling devices to prevent the backflow of drawn blood from the container or tube to the pa-tientO U.S. Patent No. 3,874,367, for example, shows a valve disposed in a chamber constructed in a needle assembly between distal and proximal needles for prevent-ing withdrawn blood from returning to the patient. This construct-ion, however, is relatively expensive not only because of the new tooling required in the manufac-ture of such needle assemblies bu-t because of the additional parts required. Such devices require two needles, two hubs, and the s-teps of securing each needle to its hub. Such parts and steps result in relatively high manufaeturing costs.
SUMMARY OF THE INVENTION
Aeeordingly, the present invention seeks to provide a fluid eolleetion deviee whieh prevents baekflow of fluid from the eolleetion chamber of the device to the source of the fluid and which is relatively economical and ean be employed with eonventional needle assemblies and tube holders.
Briefly, the present invention provides a eolleetion deviee that ineludes an evaeuated eontainer elosed at one end and having a needle-pierceable stopper elosing the opposite end.
A fluid flow one-way valve is disposed within the eontainer whieh allows fluid to flow from the needle to the eolleetion chamber but prevents fluid flow from the eollection chamber to the needle.
In one broad aspect, the invention comprehends a blood collection deviee which ineludes a eontainer having one end elosed and a blood eollee-tion ehamber for receiving a blood sample. A needle-piereeable stopper eloses the opposite end 40~6 of the con-tainer and is adapted to be pierced by a needle connected to a source of blood, the collection chamber normally having a negative pressure therein. A fluid pressure different-ial responsive one-way valve is disposed in the contalner between the stopper and the collection chamber in the path of blood flow from a needle piercing the stopper to the collection chamber and includes a pair of valve members relatively movable for opening and closing the valve. The valve is responsive to fluid pressure differentials thereacross such that the valve is open to allow blood flow from the needle through the valve -to the collection chamber when the fluid pressure on the needle side of the valve is greater than that on the collection chamber side thereof, but is otherwise normally closed to prevent the flow of blood from the collection chamber -through the valve to the needle. The valve members are normally sealingly engaged with each other to close the valve, one of the valve ~embers being movable relative to the other valve members to open the valve and allow blood flow from the needle to the collection chamber when in use, the other valve member belng a hollow member providing a valve chamber disposed to receive the tip of a needle piercing the stopper when in use and allowing the passage of blood therethrough to -the collectlon chamber. The onevalve member normally closes the valve chamber Erom the collection chamber, and -the valve includes means for normally urging the one valve member into sealing engagement with the other valve member.
.:
BRIEF DESCRIPTION OF THE DRAWINGS
-Figure 1 is a side elevation partly in section of a fluid collection device in accordance with a preferred embodiment of the present invention with the device shown disposed in a tube and needle holder;
Figure 2 is an enlarged elevational cross-sé~ti~n~1 view of the stopper and fluid pressure responsive~
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2~ -~"
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valve of Figure l;
Figure 3 is a side elevational view partly in section of the val;/e of Figure 2 rotated 30;
Figure 4 is a bottoll end view of ~he upper menber of the valve of Figure 2; and Figure 5 is a cross-sectional elevational view of a valve in accordance with a modified elnbodilllent.
DESCRIPTIO~I_Oi_T~_F P~EFr_RED E~l"ODI~lrrlTS
Referring now to the drawings and particularly to Fi~ure 1 a fluid collection device 10 is shown disposed in a conventional tuDe and needle holder 12. The holder 1~ includes a cylindrical barrel 14 havin~ an open lower end 16 for receiving the collection device 10 and an upper closed end 1~ carrying a needle assembly 20 having a double-ended needle cannula or hypoderlnic needle 21. i~eedle 21 is fixed to a threaded hub 22 thdt is tnreadedly connected to tine holder 12. The needle 21 extends longitudinally : alon~ the axis of the holder and has a distal portion ~3 exterio,^ to the holder and a proxil~al portion 24 extending proximally witllin the barrel 14.
Collection device 10 includes a blood collection container or tub~ 26 having an integrally closed botton~ end 2" and an upper open end 30 in wilich is . 20 disposed a needle-pierceable stopper 32. The tube 26 is preferably of glass :~ and -the stopper 32 is of a suitable eldstonleric or rubber nlaterial that will nlaintain a negative pressure within the tube 26. Tube 20 provides d blood collec-tion chal,lber 34 within tne tube ~elow the stopper 32. Stopper 32 is self-sealing after the needle 21 nas pierced the stopper and is subsequently removed.
In Figure 2 the stopper 32 is shown provided with a relatively hard needle guide insert 3~ which serves to (Juide tne needle into -the central portion 3~
of the stopper even if it is somewhat off center. The stopper 32 has a lower cyllndrical portion 40 which extends into the tube 20 and whicll is provided Witil a bottom centrcll cylindrical recess 42 whicll is directly below central : 30 pOI^tiOIl 30.
Disposed withill the collection tube 20 below tne stopper 32 is a one-~Ja~ fluid flow valve indicated generally at 44. Valve 44 is received in the recess 42 of the stop~er. The valve 44 includes an upper cylindrical ~4~
body member 46 haviny an annular ridge 48 which extends outwardly and down-wardly from the upper end of tne body member and has an outer annular sharp edge whicn frictionally holds the valve to the underside of stopper 32 within recess 4~. The body member 4G has a valve cha~ber 50 extending through it which is in the series flow path between the needle 21 and collection chanlber 34.
Valve 44 has a movable valve meMber 52 shown in the form of a resilient rubber diaphragm closing the lower end of the valve chamber 50. Diaphragm 52 is normally held in the valve closed position as shown in Fiyure 2 by a lower end cap 54 which is frictionally connected to the lower end portion of the body member 46. Cap 54 is circular and has an upwardly.extending ce~ntral abutment 56 engaging the central portion of the diaphragm to cause the upper marginal surface of the diaphrasm 52 to resiliently engage the bottom open end of the body member 46 and sealingly close the bottom end of valve chamber 50.
Diaphragm 52 is disc-shaped and preferably formed of a suitable elastomeric or rubber material. The cap 54 is cup-shaped and may be formed of a suitable plastic. Also the body member 46 can be formed of a suitable plastic material or of metal if desired.
As also seen in Figures 3 and 4 the upper body member 46 is provided with a plurality of circumferentially spaced flat por-tions 58 witn a plurality of circumferentially spaced arcuate relatively small portions 60 alternating with the flat portions 58. The cap 54 has an inner diameter such that when ~he lower portion of the body member 46 is inserted into the cap as shown in Figure 3 the inner walls of the cap frictionally engage the arcuate portions 60 to frictlonally hold tne cap on the lower end of body 46. The flat portions 58 are spaced from the cap 54 to permit blood to flow between them to collection chamber 34 when the valve is open during the filling of the collection tube.
The stopper 32 and valve 44 may be inserted into tnhe tube 2b while in an air evacua-ted chamber during assembly of the device 10. The valve chamber 50 and collection chamber 34 are provided with a negative pressure in accordance with the desired amount of blood to be drawn into the collection chamber. With the pressures on opposlte sides of tlle diaphragm 52 equal the abu-tment 56 of cap 54 normally maintains the diapnra-gm 52 in the closed condition as seen in Figure 2. l~hen a fluid pressure differential exists across tne diaphragm 52 such tnat the pressur~ in valve chamber 50 is positive with respect to the pressure in collection chamber 34, the peripheral or marginal portions of the diaphragln are moved away from the bottom end of valve member 4$
to allow fluid to pass from the valve chamber 50 into cap 54 and then into collection chamber 34.
In use, af-ter the needle assembly 20 is attached to the barrel 14, the distal end 23 of the needle may be inserted into a vein 66 of a patient from whom a blood sample is to be collected. The collection device 10 is tllen inserted into and guided by the holder 12 toward the proximal end portion 24 ; of needle 21. ~hen needle portion 24 has fully penetrated the stopper, it enters the valve chamber 50 and fluid communication between the blood in vein 66 and the air evacuated collection chamber 34 is effected. Since the fluid pressure in valve chamber 50 is now positive with respect to the pressure in collection chamber 34, the valve 44 will be opened and blood flows from valve chamber 50 past the diaphragm 52, upwardly into the spaces between the flat portions 5~3 of the body 46 and the inner walls of the cap ~4, downwardly between the inner walls of the tube 26 and the outer walls of the cap, and then into the collection chamber 34. As the collection chamber fills, the pressure differential across the diaphragm 52 will decrease until the pressure is small or substantially equalized, and then the resiliency of the diapnragrn will again close against the bottom end of body 46 to close the va1ve. '~Ihen valve 44 is closed, no blood can flow from the collection chamber 34 bac~ through the valve and into the patient. Thus, where chemicals or ~, other materials are disposed in the tube 26 by the manufacturer, the blood - mixing with such chemicals cannot be inadverterltly returned to the patient since the valve 44 is closed to such flow.
Figure 5 sho~ls a one-way valve 70 of modified construction connected to a needle-pierceable rubber stopper shown in phantom at 72 and which is disposed in a blood collection tube which is partially shown in phantom at 74.
~/alve 70 includes a cylindrical body 76 having a valve chamber 78 and an integral, diametrically extending rod ;30. The rod ~30 has an axial stem ~2 fixed to it which extends axially below the bottom end of body 76. A generally : .
f circular or disc-like diapnragm 84 is disposed on the extendins lower end of the stem 82. The diaphragm 84 has a central hole of smaller diameter than that of the stem so that the diaphraglll can be readily pushed onto the stem to the desired position shown in Figure-5. The diaphragm 84 is shown ; resiliently urged against the lower encl of the body member to close the bottom of chamber 78. Diaphraglll 84 may be formed of any suitable, resilient rubber or other elas-tomeric material.
Valve 70 of Figure 5 operates in a manner similar to that of valve 44 of Figure 1. ~hen a blood collection needle pierces the stopper 72, blood lQ from the patient's vein flows into valve chamber 78 and through the valve to the collection portion of the tube below the stopper and valve. Tne valve is open to pass this flow of blood since the upper side of the diaphragm will be positive with respect to the negative pressure on the bottom side of the valve.
As a collection tube 74 fills, the original relatively high negative pressure decreases with the pressure differential across the ciiaphragm 84 also decreasing. ~Ihen the pressure difrerential across the valve is relatively low or approaching or reaching zero, the resiliency of the diaphragm causes the marginal surfaces of the upper side of the diaphragm to again sealingly engage the annular bottom end of the body 76 to thereby close the valve 70. Under these conditions, blood in the collection chamber of tube 74 cannot flow past the diaphragm 84 so that this blood cannot be returned to the patient.
In some cases, after tne filled collection tube is removed from the holder 12, it is inserted in a centrifuge to separate the serum from the cellular phase for performing laboratory tests on the separated serum. Where serum tests are run ln this manner, the embodiment shown in Figures 1~4 has the advantage of tending to trap a blood clot in the one-way valve. For example, a blood clot which forms during centrifugation in the blood that may remain in the valve chamber 50, would tend to be wedged and trapped in the spaces between the facing inner walls of the cap 54 and the inclined surfaces 58 of the body member 46. Such a clot would be removed from -the tube 26 with the stopper 32 as it is removed to open the tube for extracting the separated serum.
.~ ' ' .
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~L4~
. .
Both of tne pressure responsive valves 44 and 70 are disposed in series in the blood flow path from the patient to the container and are responsive to predetermined pressure differentials across their mova~le valve members such as the diaphragms for alldwing blood flow in ane direction through them that is from the valve chamber to the collection chanlbers. Tne valves are open only when fluid flowsjfrom the valve chamber to the collection chamber. In the closed condition of the two valves the condition shown in the drawing the valve chambers 50 and 78 provide closed fluid or airtight chambers since one end of each chamber is sealingly closed by the stopper and the opposite end by the movable valve member or diaphragm.
~lith the valve chamber closed in this manner blood from the valve chamber cannot be returned to the patient since air or blood from the collection chamber could not enter t~le valve chamber to replace such blood flow. Thus blood cannot flow back from the col'lection or valve chamber so that economical non-sterile blood collection devices can be employed.
The stopper and valve are readily assembled together by simply inserting the valve into the stopper recess. This provides a stopper and valve assembly which is readily inserted into the collection tube.
The size or length of the upper valve member or chamber and size of the proximal portion of the needle cannula are so related that when the collection tube is inserted fully into the holder the lower tip of the needle cannula is within the valve chamber'between the stopper and diaphragm.
As various changes could be made in the above construction without departing frorn the scope of the invention it is intended that all matter contained in the above description or shown in the accompanying drawing shall be in-terpreted as illustrative and not in a limiting sense.
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valve of Figure l;
Figure 3 is a side elevational view partly in section of the val;/e of Figure 2 rotated 30;
Figure 4 is a bottoll end view of ~he upper menber of the valve of Figure 2; and Figure 5 is a cross-sectional elevational view of a valve in accordance with a modified elnbodilllent.
DESCRIPTIO~I_Oi_T~_F P~EFr_RED E~l"ODI~lrrlTS
Referring now to the drawings and particularly to Fi~ure 1 a fluid collection device 10 is shown disposed in a conventional tuDe and needle holder 12. The holder 1~ includes a cylindrical barrel 14 havin~ an open lower end 16 for receiving the collection device 10 and an upper closed end 1~ carrying a needle assembly 20 having a double-ended needle cannula or hypoderlnic needle 21. i~eedle 21 is fixed to a threaded hub 22 thdt is tnreadedly connected to tine holder 12. The needle 21 extends longitudinally : alon~ the axis of the holder and has a distal portion ~3 exterio,^ to the holder and a proxil~al portion 24 extending proximally witllin the barrel 14.
Collection device 10 includes a blood collection container or tub~ 26 having an integrally closed botton~ end 2" and an upper open end 30 in wilich is . 20 disposed a needle-pierceable stopper 32. The tube 26 is preferably of glass :~ and -the stopper 32 is of a suitable eldstonleric or rubber nlaterial that will nlaintain a negative pressure within the tube 26. Tube 20 provides d blood collec-tion chal,lber 34 within tne tube ~elow the stopper 32. Stopper 32 is self-sealing after the needle 21 nas pierced the stopper and is subsequently removed.
In Figure 2 the stopper 32 is shown provided with a relatively hard needle guide insert 3~ which serves to (Juide tne needle into -the central portion 3~
of the stopper even if it is somewhat off center. The stopper 32 has a lower cyllndrical portion 40 which extends into the tube 20 and whicll is provided Witil a bottom centrcll cylindrical recess 42 whicll is directly below central : 30 pOI^tiOIl 30.
Disposed withill the collection tube 20 below tne stopper 32 is a one-~Ja~ fluid flow valve indicated generally at 44. Valve 44 is received in the recess 42 of the stop~er. The valve 44 includes an upper cylindrical ~4~
body member 46 haviny an annular ridge 48 which extends outwardly and down-wardly from the upper end of tne body member and has an outer annular sharp edge whicn frictionally holds the valve to the underside of stopper 32 within recess 4~. The body member 4G has a valve cha~ber 50 extending through it which is in the series flow path between the needle 21 and collection chanlber 34.
Valve 44 has a movable valve meMber 52 shown in the form of a resilient rubber diaphragm closing the lower end of the valve chamber 50. Diaphragm 52 is normally held in the valve closed position as shown in Fiyure 2 by a lower end cap 54 which is frictionally connected to the lower end portion of the body member 46. Cap 54 is circular and has an upwardly.extending ce~ntral abutment 56 engaging the central portion of the diaphragm to cause the upper marginal surface of the diaphrasm 52 to resiliently engage the bottom open end of the body member 46 and sealingly close the bottom end of valve chamber 50.
Diaphragm 52 is disc-shaped and preferably formed of a suitable elastomeric or rubber material. The cap 54 is cup-shaped and may be formed of a suitable plastic. Also the body member 46 can be formed of a suitable plastic material or of metal if desired.
As also seen in Figures 3 and 4 the upper body member 46 is provided with a plurality of circumferentially spaced flat por-tions 58 witn a plurality of circumferentially spaced arcuate relatively small portions 60 alternating with the flat portions 58. The cap 54 has an inner diameter such that when ~he lower portion of the body member 46 is inserted into the cap as shown in Figure 3 the inner walls of the cap frictionally engage the arcuate portions 60 to frictlonally hold tne cap on the lower end of body 46. The flat portions 58 are spaced from the cap 54 to permit blood to flow between them to collection chamber 34 when the valve is open during the filling of the collection tube.
The stopper 32 and valve 44 may be inserted into tnhe tube 2b while in an air evacua-ted chamber during assembly of the device 10. The valve chamber 50 and collection chamber 34 are provided with a negative pressure in accordance with the desired amount of blood to be drawn into the collection chamber. With the pressures on opposlte sides of tlle diaphragm 52 equal the abu-tment 56 of cap 54 normally maintains the diapnra-gm 52 in the closed condition as seen in Figure 2. l~hen a fluid pressure differential exists across tne diaphragm 52 such tnat the pressur~ in valve chamber 50 is positive with respect to the pressure in collection chamber 34, the peripheral or marginal portions of the diaphragln are moved away from the bottom end of valve member 4$
to allow fluid to pass from the valve chamber 50 into cap 54 and then into collection chamber 34.
In use, af-ter the needle assembly 20 is attached to the barrel 14, the distal end 23 of the needle may be inserted into a vein 66 of a patient from whom a blood sample is to be collected. The collection device 10 is tllen inserted into and guided by the holder 12 toward the proximal end portion 24 ; of needle 21. ~hen needle portion 24 has fully penetrated the stopper, it enters the valve chamber 50 and fluid communication between the blood in vein 66 and the air evacuated collection chamber 34 is effected. Since the fluid pressure in valve chamber 50 is now positive with respect to the pressure in collection chamber 34, the valve 44 will be opened and blood flows from valve chamber 50 past the diaphragm 52, upwardly into the spaces between the flat portions 5~3 of the body 46 and the inner walls of the cap ~4, downwardly between the inner walls of the tube 26 and the outer walls of the cap, and then into the collection chamber 34. As the collection chamber fills, the pressure differential across the diaphragm 52 will decrease until the pressure is small or substantially equalized, and then the resiliency of the diapnragrn will again close against the bottom end of body 46 to close the va1ve. '~Ihen valve 44 is closed, no blood can flow from the collection chamber 34 bac~ through the valve and into the patient. Thus, where chemicals or ~, other materials are disposed in the tube 26 by the manufacturer, the blood - mixing with such chemicals cannot be inadverterltly returned to the patient since the valve 44 is closed to such flow.
Figure 5 sho~ls a one-way valve 70 of modified construction connected to a needle-pierceable rubber stopper shown in phantom at 72 and which is disposed in a blood collection tube which is partially shown in phantom at 74.
~/alve 70 includes a cylindrical body 76 having a valve chamber 78 and an integral, diametrically extending rod ;30. The rod ~30 has an axial stem ~2 fixed to it which extends axially below the bottom end of body 76. A generally : .
f circular or disc-like diapnragm 84 is disposed on the extendins lower end of the stem 82. The diaphragm 84 has a central hole of smaller diameter than that of the stem so that the diaphraglll can be readily pushed onto the stem to the desired position shown in Figure-5. The diaphragm 84 is shown ; resiliently urged against the lower encl of the body member to close the bottom of chamber 78. Diaphraglll 84 may be formed of any suitable, resilient rubber or other elas-tomeric material.
Valve 70 of Figure 5 operates in a manner similar to that of valve 44 of Figure 1. ~hen a blood collection needle pierces the stopper 72, blood lQ from the patient's vein flows into valve chamber 78 and through the valve to the collection portion of the tube below the stopper and valve. Tne valve is open to pass this flow of blood since the upper side of the diaphragm will be positive with respect to the negative pressure on the bottom side of the valve.
As a collection tube 74 fills, the original relatively high negative pressure decreases with the pressure differential across the ciiaphragm 84 also decreasing. ~Ihen the pressure difrerential across the valve is relatively low or approaching or reaching zero, the resiliency of the diaphragm causes the marginal surfaces of the upper side of the diaphragm to again sealingly engage the annular bottom end of the body 76 to thereby close the valve 70. Under these conditions, blood in the collection chamber of tube 74 cannot flow past the diaphragm 84 so that this blood cannot be returned to the patient.
In some cases, after tne filled collection tube is removed from the holder 12, it is inserted in a centrifuge to separate the serum from the cellular phase for performing laboratory tests on the separated serum. Where serum tests are run ln this manner, the embodiment shown in Figures 1~4 has the advantage of tending to trap a blood clot in the one-way valve. For example, a blood clot which forms during centrifugation in the blood that may remain in the valve chamber 50, would tend to be wedged and trapped in the spaces between the facing inner walls of the cap 54 and the inclined surfaces 58 of the body member 46. Such a clot would be removed from -the tube 26 with the stopper 32 as it is removed to open the tube for extracting the separated serum.
.~ ' ' .
~p ~
~L4~
. .
Both of tne pressure responsive valves 44 and 70 are disposed in series in the blood flow path from the patient to the container and are responsive to predetermined pressure differentials across their mova~le valve members such as the diaphragms for alldwing blood flow in ane direction through them that is from the valve chamber to the collection chanlbers. Tne valves are open only when fluid flowsjfrom the valve chamber to the collection chamber. In the closed condition of the two valves the condition shown in the drawing the valve chambers 50 and 78 provide closed fluid or airtight chambers since one end of each chamber is sealingly closed by the stopper and the opposite end by the movable valve member or diaphragm.
~lith the valve chamber closed in this manner blood from the valve chamber cannot be returned to the patient since air or blood from the collection chamber could not enter t~le valve chamber to replace such blood flow. Thus blood cannot flow back from the col'lection or valve chamber so that economical non-sterile blood collection devices can be employed.
The stopper and valve are readily assembled together by simply inserting the valve into the stopper recess. This provides a stopper and valve assembly which is readily inserted into the collection tube.
The size or length of the upper valve member or chamber and size of the proximal portion of the needle cannula are so related that when the collection tube is inserted fully into the holder the lower tip of the needle cannula is within the valve chamber'between the stopper and diaphragm.
As various changes could be made in the above construction without departing frorn the scope of the invention it is intended that all matter contained in the above description or shown in the accompanying drawing shall be in-terpreted as illustrative and not in a limiting sense.
Claims (6)
1. A blood collection device comprising a container having one end closed and a blood collection chamber for receiving a blood sample, a needle-pierceable stopper closing the opposite end of said container and adapted to be pierced by a needle connected to a source of blood, said collection chamber normally having a negative pressure therein, and a fluid pressure differential responsive one-way valve disposed in said container between said stopper and said collection chamber in the path of blood flow from a needle piercing said stopper to said collection chamber and including a pair of valve members relatively movable for opening and closing said valve, said valve being responsive to fluid pressure differentials thereacross such that said valve is open to allow blood flow from the needle through said valve to said collection chamber when the fluid pressure on the needle side of said valve is greater than that on the collection chamber side thereof but is otherwise normally closed to prevent the flow of blood from said collection chamber through said valve to the needle, said valve members being normally sealingly engaged with each other to close said valve, one of said valve members being movable relative to the other said valve members to open said valve and allow blood flow from the needle to said collection chamber when in use, said other valve member being a hollow member providing a valve chamber disposed to receive the tip of a needle piercing said stopper when in use and allowing the passage of blood therethrough to said collection chamber, said one valve member normally closing said valve chamber from said collection chamber, said valve including means for normally urging said one valve member into sealing engagement with said other valve member.
2. A blood collection device comprising a container having one end closed and a blood collection chamber for receiving a blood sample, a needle-pierceable stopper closing the opposite end of said container and adapted to be pierced by a needle connected to a source of blood, said collection chamber normally having a negative pressure therein, and a fluid pressure differential responsive one-way valve disposed in said container between said stopper and said collection chamber in the path of blood flow from a needle piercing said stopper to said collection chamber and including a pair of valve members relatively movable for opening and closing said valve, said valve being responsive to fluid pressure differentials thereacross such that said valve is open to allow blood flow from the needle through said valve to said collection chamber when the fluid pressure on the needle side of said valve is greater than that on the collection chamber side thereof but is otherwise normally closed to prevent the flow of blood from said collection chamber through said valve to the needle, said valve members being normally sealingly engaged with each other to close said valve, one of said valve members being movable relative to the other said valve members to open said valve and allow blood flow from the needle to said collection chamber when in use, said other valve member being a hollow member providing a valve chamber disposed to receive the tip of a needle piercing said stopper when in use and allowing the passage of blood therethrough to said collection chamber, said one valve member normally closing said valve chamber from said collection chamber, said valve in-cluding a generally cup-shaped member connected to said hollow member and normally urging said one valve member into sealing engagement with the bottom of said hollow member to close said valve.
3. The device of Claim 2, wherein radially inner wall portions of said cup-shaped member and facing radially outer surface portions of said hollow member are spaced to provide blood flow paths from said valve chamber to said collection chamber.
4. The device of Claim 3 wherein said blood flow paths narrow at the open end of said cup-shaped member.
5. The device of Claim 1 wherein said valve includes blood clot trapping passage means in said path of blood flow including facing wall surfaces of said valve for trapping a blood clot in said valve to prevent the blood clot from entering said collection chamber during centrifugation of the device.
6. The device of Claim 5 wherein said facing wall surfaces cause blood flow in a direction opposite to the direction of blood flow from said needle before flowing into said collection chamber.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US810,257 | 1977-06-27 | ||
| US05/810,257 US4296759A (en) | 1977-06-27 | 1977-06-27 | Blood collection device and method with anti-backflow means |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1144026A true CA1144026A (en) | 1983-04-05 |
Family
ID=25203410
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000305848A Expired CA1144026A (en) | 1977-06-27 | 1978-06-20 | Blood collection device with anti-backflow means |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US4296759A (en) |
| CA (1) | CA1144026A (en) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5343900A (en) * | 1988-10-20 | 1994-09-06 | Galloway Company | Needle bundle driver and methods |
| US5086813A (en) * | 1988-10-20 | 1992-02-11 | Galloway Edwin J | Aseptic fluid transfer methods |
| US4941517A (en) * | 1988-10-20 | 1990-07-17 | Galloway Trust | Aseptic fluid transfer apparatus and methods |
| KR20010049172A (en) * | 1997-04-08 | 2001-06-15 | 인젝티미드, 인코포레이티드. | Method and apparatus for collecting blood |
| US6186960B1 (en) * | 1998-10-20 | 2001-02-13 | Texas Applied Biomedical Services, Inc. | Disposable medical collection tube holder with retractable needle |
| US6126618A (en) * | 1999-01-14 | 2000-10-03 | Baxter International Inc. | Apparatus for obtaining liquid samples |
| US6077245A (en) * | 1999-02-18 | 2000-06-20 | Texas Applied Biomedical Services, Inc. | Disposable syringe with retractable needle |
| US6387086B2 (en) | 1999-07-29 | 2002-05-14 | Baxter International Inc. | Blood processing set including an integrated blood sampling system |
| US7824343B2 (en) | 1999-07-29 | 2010-11-02 | Fenwal, Inc. | Method and apparatus for blood sampling |
| US7435231B2 (en) | 1999-07-29 | 2008-10-14 | Fenwal, Inc. | Biological sample device receiver |
| EP1377216A2 (en) | 1999-07-29 | 2004-01-07 | Baxter International Inc. | Sampling tube holder for blood sampling system |
| US7927316B2 (en) * | 2002-04-26 | 2011-04-19 | Millipore Corporation | Disposable, sterile fluid transfer device |
| US7293477B2 (en) | 2003-12-23 | 2007-11-13 | Millipore Corporation | Disposable, pre-sterilized fluid receptacle sampling device |
| US7055401B2 (en) | 2004-03-15 | 2006-06-06 | Haemonetics Corporation | Closed method and system for the sampling and testing of fluid |
| US7396343B2 (en) * | 2004-05-03 | 2008-07-08 | Clear View Patient Safty Products, Llc | Blood drawing device with flash detection |
| US7160267B2 (en) * | 2004-05-03 | 2007-01-09 | Clear View Patent Safety Products, Llc | Blood drawing device with flash detection |
| US7530967B2 (en) * | 2004-05-03 | 2009-05-12 | Clearview Patient Safety Technologies, Llc | Porous multiple sample sleeve and blood drawing device for flash detection |
| SG153002A1 (en) | 2007-11-16 | 2009-06-29 | Millipore Corp | Fluid transfer device |
| US8505396B2 (en) | 2008-07-18 | 2013-08-13 | Allpure Technologies, Inc. | Fluid transfer device |
| US8544349B2 (en) | 2008-07-18 | 2013-10-01 | Allpure Technologies, Inc. | Fluid transfer device |
| WO2010008395A1 (en) | 2008-07-18 | 2010-01-21 | Allpure Technologies, Inc. | Fluid transfer device |
| FR2940440B1 (en) | 2008-12-18 | 2010-12-24 | Millipore Corp | DEVICE FOR TRANSFERRING A MEDIUM |
| FR2940439B1 (en) | 2008-12-18 | 2011-02-11 | Millipore Corp | DEVICE FOR TRANSFERRING A MEDIUM |
| US8544497B2 (en) | 2009-10-30 | 2013-10-01 | Emd Millipore Corporation | Fluid transfer device and system |
| US9568113B2 (en) | 2010-01-15 | 2017-02-14 | Allpure Technologies, Llc | Fluid transfer device |
| CN103690249B (en) * | 2013-12-31 | 2015-10-21 | 苏州大学 | A kind of Multipurpose blood collection box |
| US9975753B1 (en) | 2017-04-26 | 2018-05-22 | Sartorius Stedim North America Inc. | Detachable fluid transfer device accessory and a fluid transfer assembly |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR968833A (en) * | 1947-07-09 | 1950-12-06 | Ponctiovid Societe A Responsab | Sterile equipment for blood sampling or aseptic injection |
| US3091240A (en) * | 1958-12-29 | 1963-05-28 | Robert K Mcconnaughey | Hypodermic syringe and ventable closure means |
| US3089490A (en) * | 1960-03-14 | 1963-05-14 | Graham Chemical Corp | Disposable cartridge type hypodermic syringes |
| US3162195A (en) * | 1962-01-02 | 1964-12-22 | Dick Peter | Vacuated body fluid collection vial |
| US3181529A (en) * | 1962-07-30 | 1965-05-04 | Edgar H Wilburn | Valved body-fluid sampling tubes |
| US3577980A (en) * | 1968-05-28 | 1971-05-11 | Milton J Cohen | Fluid extraction device |
| SE377967B (en) * | 1969-06-12 | 1975-08-04 | Johnson & Johnson | |
| US3659587A (en) * | 1970-06-30 | 1972-05-02 | Affiliated Hospital Prod | Valved connector arrangement |
| US3747812A (en) * | 1971-10-21 | 1973-07-24 | Medical Concepts Inc | Syringe |
| US3874367A (en) * | 1972-06-29 | 1975-04-01 | Becton Dickinson Co | Valved blood sampling needle assembly |
| US4112924A (en) * | 1977-04-07 | 1978-09-12 | Louis Thomas Ferrara | Blood collection valve |
-
1977
- 1977-06-27 US US05/810,257 patent/US4296759A/en not_active Expired - Lifetime
-
1978
- 1978-06-20 CA CA000305848A patent/CA1144026A/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| US4296759A (en) | 1981-10-27 |
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