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`US007645424B2
`
`c12) United States Patent
`O'Donovan
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 7 ,645,424 B2
`Jan.12,2010
`
`(54) REAGENT CUVETTE
`
`(56)
`
`References Cited
`
`(76)
`
`Inventor: Michael O'Donovan, Clonmar,
`Roxborough, Middleton, County Cork
`(IE)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 11/434,211
`
`(22) Filed:
`
`May 16, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2006/0210450Al
`
`Sep. 21, 2006
`
`Related U.S. Application Data
`
`(63) Continuation of application No. PCT/IE2004/000162,
`filed on Nov. 18, 2004.
`
`(60) Provisional application No. 60/523,104, filed on Nov.
`19, 2003.
`
`(51)
`
`Int. Cl.
`(2006.01)
`BOIL 3100
`(2006.01)
`BOIL 3102
`(2006.01)
`Cl2M 1134
`(2006.01)
`Cl2M 3100
`(2006.01)
`Cl2M 3104
`(2006.01)
`Cl2M 1124
`(52) U.S. Cl. ......................... 422/102; 422/99; 422/100;
`435/288.1; 435/299.2; 435/304.1
`(58) Field of Classification Search ................. 422/102,
`422199, 100; 435/288.1, 299.2, 304.1
`See application file for complete search history.
`
`U.S. PATENT DOCUMENTS
`
`3,715,189 A
`5,954,268 A *
`6,495,373 Bl
`2002/0197631 Al
`
`2/1973 Nighohossian ............... 23/259
`9/1999 Joshi et al. .................... 239/34
`12/2002 Mauchan .................... 436/165
`12/2002 Lawrence et al.
`.............. 435/6
`
`FOREIGN PATENT DOCUMENTS
`0 573 098 A2 * 5/1993
`EP
`1026138
`4/1966
`GB
`* cited by examiner
`Primary Examiner-Walter D Griffin
`Assistant Examiner-Natasha Young
`(74) Attorney, Agent, or Firm-Jacobson Holman PLLC
`
`(57)
`
`ABSTRACT
`
`A reagent cuvette has a first chamber with an inspection part
`and a socket, and a second chamber. The socket has four
`spikes at its base. Both chambers are sealed with a membrane.
`At the point-of-care the foil membrane of the first chamber is
`peeled away by the therapist (typically general practitioner
`doctor). A sample, such as blood, is added to the chamber
`using a pipette or other device to provide a verifiable quantity
`of sample. This provides a mixture of a buffer reagent sup(cid:173)
`plied in the chamber and the sample injected into the inspec(cid:173)
`tion chamber at the point of care. The chamber is then inserted
`into the socket by gently pressing it down so that its foil
`membrane is broken by the spikes. This causes the starter
`reagent to drop down from within the second chamber into the
`inspection part of the first chamber. The inspection part is then
`inserted into an optical inspection instrument for analysis of
`the two reagents and the sample mixed together.
`
`7 Claims, 4 Drawing Sheets
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`ANCESTRY EX. 1007
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`U.S. Patent
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`US 7,645,424 B2
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`1
`REAGENT CUVETTE
`
`This is a continuation of PCT/IE04/000162 filed Nov. 18,
`2004 and published in English, claiming benefit of U.S. pro(cid:173)
`visional application No. 60/523,104, filed Nov. 19, 2003.
`
`FIELD OF THE INVENTION
`
`The invention relates to a reagent cuvette for sample analy(cid:173)
`sis.
`
`PRIOR ART DISCUSSION
`
`At present, there is often a two-stage analysis of samples,
`namely point-of-care and laboratory analysis. Typically, the
`point-of-care analysis is performed using "dry chemistry"
`techniques. This is because such techniques are simple and
`convenient to perform: a sample being placed on a strip
`coated with a dry reagent and the strip being inserted into an
`inspection instrument.
`The laboratory analysis is typically performed using "wet
`chemistry" techniques in which controlled volumes of fluid
`sample and reagent(s) are admixed and optically inspected.
`The "wet chemistry" techniques are regarded as being full
`and reliable tests, where the "dry chemistry" techniques are
`reliable only for screening purposes. Thus, a large number of
`patients may be Uilllecessarily subjected to the trouble and
`worry of further unwarranted tests beyond the point of care.
`The invention addresses this problem.
`
`SUMMARY OF THE INVENTION
`
`2
`In one embodiment, the first chamber comprises a manu(cid:173)
`ally removable cover.
`In one embodiment, said cover is a peelable membrane.
`In another aspect, the invention provides a method of per(cid:173)
`forming wet chemistry sample analysis comprising the steps
`of:
`providing a first chamber containing a controlled quantity
`of a first reagent,
`providing a second chamber containing a controlled quan(cid:173)
`tity of a second reagent,
`adding a sample to the first chamber,
`pressing the chambers together so that the reagent of the
`second chamber flows into the first chamber,
`inspecting the contents of the first chamber.
`In one embodiment, the action of pressing the chambers
`together causes a membrane across an opening of the second
`chamber to be pierced by a piercing member of the first
`chamber.
`In one embodiment, the second chamber is pushed into a
`socket of the first chamber, said piercing member is within the
`socket, and the reagent of the second chamber flows down(cid:173)
`wardly into the first chamber when the membrane is pierced.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`Brief Description of the Drawings
`
`10
`
`15
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`20
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`25
`
`The invention will be more clearly understood from the
`following description of some embodiments thereof, given by
`way of example only with reference to the accompanying
`30 drawings in which:
`FIG. 1 is a perspective view of both parts of a reagent
`cuvette of the invention, and
`FIGS. 2, 3, and 4 are perspective, cut-away/sectional, and
`cross sectional views respectively of the cuvette with both
`35 parts together.
`
`According to the invention there is provided a reagent
`cuvette comprising at least first and second reagent chambers
`each containing a reagent, and a transfer means for transfer of
`a reagent to the first chamber from the second chamber for
`admixture of the reagents in the first chamber.
`In one embodiment, the transfer means is for single and
`destructive use.
`In one embodiment, the transfer means comprises a mem(cid:173)
`brane across an opening of the second chamber, and a pierc(cid:173)
`ing member secured to the first chamber, whereby said second 40
`chamber membrane is pierced as the second chamber is
`pushed towards the first chamber
`In one embodiment, the first chamber comprises a socket
`for receiving the second chamber.
`In one embodiment, the socket comprises the piercing 45
`member.
`In one embodiment, the piercing member is located at the
`base of the socket.
`In one embodiment, there are a plurality of piercing mem(cid:173)
`bers mounted peripherally around the base of the socket.
`In one embodiment, the second chamber is a friction fit in
`the first chamber.
`In one embodiment, the socket and the second chamber
`have round cross-sectional configurations.
`In another embodiment, the second chamber comprises a
`rim around an opening, the rim having a larger thickness than
`a wall of the second chamber, said rim being a friction fit
`within the socket.
`In one embodiment, the first chamber comprises a lower 60
`inspection part having a wall which is transparent to analysis
`radiation, and the socket is located above the inspection part.
`In one embodiment, the socket and the inspection part are
`integral.
`In one embodiment, the socket is wider than the inspection
`part and they are interconnected by a shoulder, and said
`shoulder supports the piercing member.
`
`DESCRIPTION OF THE EMBODIMENTS
`
`Referring to the drawings there is shown a reagent cuvette
`1 for point-of-care analysis with laboratory accuracy. The
`cuvette 1 comprises two main parts, namely a first chamber 2
`of approximately 64 mm height and a separate second cham(cid:173)
`ber 3. The first chamber 2 and the second chamber 3 are of
`transparent plastics material. Both parts of the cuvette are of
`moulded plastics construction.
`The first chamber 2 comprises an inspection part 5 and a
`socket 6 for receiving the chamber 3 in use, as described in
`more detail below. The inspection part 5 is of square cross(cid:173)
`section, and extends for approximately two-thirds of the
`50 height of the chamber 2.
`The socket 6 is of circular cross-section, tapering out(cid:173)
`wardly and upwardly at a small angle. It is wider than the
`inspection part 5, being connected to it by an integral shoul(cid:173)
`der. The chamber 2 is sealed by a foil membrane 7 extending
`55 across the top of the socket 6, and this seals in a buffer reagent
`supplied within the chamber 2.
`The chamber 3 is of circular cross-section, having a wall 10
`tapering outwardly towards its opening. The wall is thicker
`around its opening, forming a rim 11.
`Referring particularly to FIGS. 3 and 4 there are four
`piercing members, in this embodiment spikes 20 equally
`spaced-apart around the base of the socket 6, on the shoulder
`connecting it to the inspection part 5. The spikes 20 are
`located so that there is just enough space for the rim 11 of the
`65 chamber 3 to fit between the spikes 20 and the wall of the
`socket 6 with a friction fit when the chamber 3 is pressed
`down into the socket 6 with its opening facing downwardly.
`
`6
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`

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`US 7,645,424 B2
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`10
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`3
`During manufacture, a buffer reagent is injected into the
`chamber 2, and the foil membrane 7 is sealed in place across
`the mouth of the socket 6.
`Also, a starter reagent is injected into the chamber 3, and
`this is also sealed with a foil membrane (not shown).
`Before completion of manufacture of the cuvette 1 the
`volumes of the reagents in the chambers 2 and 3 are verified
`and, of course, production records are generated for the
`chemical compositions and other relevant data concerning the
`reagents in both chambers.
`In use, at the point-of-care the foil membrane 7 is peeled
`away by the therapist (typically general practitioner doctor).
`A sample, such as blood, is added to the chamber 2 using a
`pipette or other device to provide a verifiable quantity of
`sample. This provides a mixture of the buffer reagent supplied
`with the cuvette 1 and the sample injected into the inspection 15
`chamber 2 at the point of care.
`The chamber 3 is then (while still sealed and with its
`opening facing down as shown in FIG. 1) inserted into the
`socket 6 by gently pressing it down so that its foil membrane
`is broken by the spikes 20. This causes the starter reagent to 20
`drop down from within the chamber 3 into the inspection part
`5 of the chamber 2. The foil material of this membrane is both
`pierced and torn by the spikes 20 so that the full quantity of
`starter reagent drops into the inspection part 5.
`The resultant transfer of the starter reagent into the mixture 25
`of sample and buffer reagent in the chamber 2 provides a
`mixture which can be analysed by an optical instrument at the
`point of care. The combination of the chambers 2 and 3 are
`effectively a single chamber, with the chamber 3 being a
`friction fit within the socket 6. The inspection part 5 is 30
`inserted into an optical inspection instrument for optical
`analysis of the sample/reagent mixture.
`The quantities of both reagents are verifiable and accurate,
`so that when the inspection part 5 is inserted in an optical
`analysis instrument there is full and immediate analysis.
`Thus, the point of care therapist can quickly and easily add 35
`the sample to the inspection chamber, and then quickly and
`easily add the starter reagent. Because of the repeatable,
`verifiable, and accurate nature of admixture of the sample and
`reagents the invention achieves laboratory-level inspection
`quality with point-of-care convenience and speed.
`Thus, the invention provides for wet chemistry analysis at
`the point-of-care, effectively bringing fill laboratory analysis
`to the point-of-care in a simple and convenient marmer.
`The invention finds application at many locations such a
`point-of-care emergency clinics, non-laboratory facilities in 45
`hospitals, and remote doctor clinics in the developing world.
`The invention is not limited to the embodiments described
`but may be varied in construction and detail. For example,
`there may be a different configuration of piercing member. In
`one example, a single spike is centrally located, being sup-
`ported by radial support arms. In another embodiment, the
`piercing member takes the form of a blade to cut along a
`longer length of the membrane. The socket may alternatively
`include a cover for covering the starter reagent chamber after
`it has been inserted into the socket. This would ensure that it
`is held in place in the socket, and may also provide a tamper- 55
`evident seal for security purposes. Also, the socket may
`include a tamper-evident fastener for retaining the starter
`reagent chamber.
`The invention claimed is:
`1. A reagent cuvette comprising
`at least first and second reagent chambers each containing
`a reagent, and
`transfer means for transfer of a reagent to the first chamber
`from the second chamber for admixture of the reagents
`in the first chamber,
`the transfer means being for single and destructive use,
`
`4
`the transfer means including a membrane across an open(cid:173)
`ing of the second chamber sealing in the reagent of the
`second chamber, and piercing members secured to the
`first chamber, whereby said second chamber membrane
`is pierced as the second chamber is pushed towards the
`first chamber;
`the first chamber including a socket for receiving the sec(cid:173)
`ond chamber, and the second chamber being in a friction
`fit in the socket;
`a plurality of the piercing members mounted peripherally
`around a base of the socket;
`the first chamber including a lower inspection part having
`a wall which is transparent to analysis radiation, and the
`socket being located above the inspection part; and
`the first chamber including a manually removable peelable
`membrane cover.
`2. The reagent cuvette as claimed in claim 1, wherein the
`socket and the second chamber have round cross-sectional
`configurations.
`3. The reagent cuvette as claimed in claim 1, wherein the
`second chamber includes a rim around an opening, the rim
`having a larger thickness than a wall of the second chamber,
`said rim being a friction fit within the socket.
`4. The reagent cuvette as claimed in claim 1, wherein the
`socket and the inspection part are integral.
`5. The reagent cuvette as claimed in claim 1, wherein the
`socket is wider than the inspection part, and the socket and the
`inspection part are interconnected by a shoulder, and said
`shoulder supports the piercing members.
`6. A method of performing wet chemistry sample analysis
`with a reagent cuvette including at least first and second
`reagent chambers each containing a reagent, and a transfer
`means for transfer of a reagent to the first chamber from the
`second chamber for admixture of the reagents in the first
`chamber, the transfer means being for single and destructive
`use, the transfer means including a membrane across an open-
`ing of the second chamber sealing in thereagent of the second
`chamber, and piercing members secured to the first chamber,
`whereby said second chamber membrane is pierced as the
`40 second chamber is pushed towards the first chamber; the first
`chamber including a socket for receiving the second chamber,
`and the second chamber being in a friction fit in the socket
`when the second chamber is pressed down into the socket; a
`plurality of the piercing members mounted peripherally
`around a base of the socket; the first chamber including a
`lower inspection part having a wall which is transparent to
`analysis radiation, and the socket being located above the
`inspection part; the first chamber including a manually
`removable peelable membrane cover, the first chamber con(cid:173)
`taining a controlled quantity of a first reagent and the second
`chamber contains a controlled quantity of a second reagent,
`the method comprising the steps of:
`peeling away the membrane cover from the first chamber,
`and adding a sample to the first chamber inspection part
`to provide a mixture of the first reagent and the sample,
`pressing the second chamber into the socket so that the
`piercing members of the first chamber pierce the mem(cid:173)
`brane of the second chamber so that the reagent of the
`second chamber flows into the first chamber inspection
`part, and
`inspecting the contents of the first chamber.
`7. A method as claimed in claim 6, wherein the inspection
`part of the first chamber is inserted into an optical inspection
`instrument for optical analysis of the sample/reagent mixture.
`
`50
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`60
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`65
`
`* * * * *
`
`7
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`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`: 7,645,424 B2
`PATENT NO.
`APPLICATION NO. : 11/434211
`: January 12, 2010
`DATED
`INVENTOR(S)
`: Michael O'Donovan
`
`Page 1of1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`On the Title Page:
`
`The first or sole Notice should read --
`
`Subjectto any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b)
`by 39 days.
`
`Signed and Sealed this
`
`Sixteenth Day of November, 2010
`
`David J. Kappas
`Director of the United States Patent and Trademark Office
`
`8