Title of Invention	"A METHOD OF TRANSPORTING A DIAGONOSTIC SAMPLE,COLLECTED FROM AN EXAMINEE, TO A MEDICAL EXAMINATION CENTER, AND A SAMPLING KIT FOR THE SAME"
Abstract	There is disclosed a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, comprising the steps of: forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of: a sampling unit (1) having a sample retaining sheet (2), and a sample receiving bag (11); collecting a sample for the examination, from the examinee, on the sample retaining sheet (2) of the sampling unit (1) in the sampling kit, enclosing in the sample receiving bag (11) the sampling unit (1), to cause drying of the sample retained on the sample retaining sheet, and returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. A sampling kit for the said method is also disclosed.

Title of Invention

"A METHOD OF TRANSPORTING A DIAGONOSTIC SAMPLE,COLLECTED FROM AN EXAMINEE, TO A MEDICAL EXAMINATION CENTER, AND A SAMPLING KIT FOR THE SAME"

Abstract

There is disclosed a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, comprising the steps of: forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of: a sampling unit (1) having a sample retaining sheet (2), and a sample receiving bag (11); collecting a sample for the examination, from the examinee, on the sample retaining sheet (2) of the sampling unit (1) in the sampling kit, enclosing in the sample receiving bag (11) the sampling unit (1), to cause drying of the sample retained on the sample retaining sheet, and returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. A sampling kit for the said method is also disclosed.

Full Text	FIELD OF THE INVENTION The present invention relates to a sampling kit for performing a medical examination of individuals, who are, in particular, not ready or difficult to visit a hospital or a medical examination center or are residing at remote areas, by collecting samples for the medical examination from these individuals in a sampling unit and gathering them at a medical examination center and analyzing them in an appropriate way. BACKGROUND OF THE INVENTION It has been practised in general to incorporate a medical examination of an individual to be examined (referred to hereinafter as an examinee), before a possible diagnosis for a disease. Here, it is usual today for such an examinee to visit a hospital or a medical examination center to ask for a medical examination. Request for an examinee to visit hospital or medical examination center may cause sometimes to miss a proper occasion for examining for a disease. In urine analysis, the examinee collects a urine sample in a special vessel, which is then sent to a hospital or a medical examination center in a frozen state and is analyzed there. 1A By such a practice for medical examination, the collected urine sample exists in liquid state as such and cannot be sent to the hospital or medical examination center by having resort to any conventional mailing way, such as postal service etc., but should rely on restricted transporting means within limited districts, so that medical examination in wide areas using a commonly distributed transporting way has not been able to realize. On the other hand, there is a demand for performing a mass medical examination for a mass of individuals to be examined for the purpose of achieving an efficient and specialized examination, by gathering the examination samples of them collected personally or in hospitals at a certain medical examination center having expert skills and equipmemts. However, a mass transportation of liquid samples, such as urine and blood, is not favorable in the point of view of possible risk of accidents and damages. Each of the examinees is requested here to forward his or her sample directly to such medical examination center in a specially designed vessel by means of a special mailing means, such as a special postal package. SUMMARY OF THE INVENTION An object of the present invention is to provide a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, wherein the difficulties of the conventional -2- practice mentioned above can be avoided by using a sampling kit which serves for collecting one or more examination samples from the examinee and which is capable of being formed into a mailable envelop and by returning the so-formed envelop to a medical examination center for analysis of the sample via a common mailing way without relying on special practices. Another object of the present invention is to provide the said sampling kit to be used in the method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, mentioned above, which provides for collecting the examination sample(s) from the examinee easily and for being formed into a mailable envelop to be returned as such to the medical examination center via a common mailing way. Accordingly, the present invention provides : (1) A method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, said method comprising the steps of: forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of: a sampling unit having a sample retaining sheet, and a sample receiving bag, which serves for receiving the sampling unit and is provided with a moisture absorbent, and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit; -3- collecting a sample for the examination, from the examinee, on the sample retaining sheet of the sampling unit in the sampling kit, enclosing in the sample receiving bag the sampling unit, to cause drying of the sample retained on the sample retaining sheet, and returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. (2) A method as defined in the above (1), wherein the sampling unit has a structure in which both sides of the sample retaining sheet is covered each by a protective coverage. (3) A method as defined in the above (1) or (2), wherein the sampling kit contains an examination data sheet. (4) A sampling kit to be forwarded from a medical examination center to the side of an examinee and returned therefrom to the medical examination center after a sample for the examination has been collected from the examinee, comprising a sampling unit comprising a sample retaining sheet for retaining the sample collected thereon from the examinee and a sample receiving bag which serves for receiving the sampling unit and is provided with a moisture absorbent and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit. -4- (5) A sampling kit as defined in the above (4), wherein both sides of the sample retaining sheet are covered each by a protective coverage and the sample retaining sheet and the protective coverages build up together at one end thereof a hand-holding shank. (6) A sampling kit as defined in the above (4) or (5), wherein the moisture absorbent in a form of sheet is disposed so as to be attached to the sample receiving bag by intermediation by a gas-and-moisture-permeable membrane. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS Figs. 1(a), 1(b) and 1(c) show an embodiment of the sampling kit according to the present invention, wherein Figs. 1(a), 1(b) and 1(c) illustrate the sampling unit, the sample receiving bag and the mailing envelop, respectively, each in a front view. Figs. 2(a), 2(b) and 2(c) are the sectional views along the lines A-A, B-B and C-C of Figs. 1(a), 1(b) and 1(c), respectively. Fig. 3(a) illustrates a state of practical use of an embodiment of the sampling unit in a perspective view. Fig. 3(b) shows another embodiment of the sampling unit according to te present invention in a front view. Fig. 4 shows the sequence of procedures in -5- performing the method for medical examination of an examinee according to the present invention in a flow diagram. DETAILED DESCRIPTION OF THE INVENTION There is no limitation as to the disease to be diagnosed using the method for medical examination according to the present invention and there may be included every disease permitting a diagnostic presumption based on the result of analysis of the sample retained on the sample retaining sheet after it has been transported and received by the medical examination center in a dried state, wherein, in particular, diseases based on metabolic disorder, such as diabetes mellitus, gout and diseases based on congenital metabolic disorder, such as phenylketonuria, are enumerated. These diseases and disorders are possible not only for human but also for animals, such as livestock and pets. There is no restriction as to the substance to be collected as the sample for the medical examination from the examinee and every substance which can be collected from the examinee easily on the side of the examinee and which can be used for medical examination may be chosen as a target substance for the sample, including urine, blood, body fluid and so on, among which urine is enumerated due to easiness in collecting as a liquid sample. By the word "the side of the examinee" or "the examinee side" is meant every one who 6 can perform practical deed of collecting the sample from the examinee and returning it to the medical center and who may be seen by the medical examination center as representative of the examinee, including the examinee him- or herself, kinships, care-attendants, helpers, legal representatives, medical practitioner, nurse and hospital. The sampling unit according to the present invention comprises a sample retaining sheet. The sample retaining sheet may preferably be made of a material having ample voids and little exudative nature, such as paper, spongy etc., to be served for absorbing and retaining, in particular, a liquid sample for the medical examination, such as urine, blood and body fluids. As a material which is especially not subject to denaturing and is non-exuding, a filter paper used for analytical purpose is favorable. The size of the sample retaining sheet may favorably be suited for retaining an amount of the sample sufficient to carry out the analysis. The sample retaining sheet should have a shape adapted to be enclosed in the sample receiving bag suited for forwarding and returning to and from the examinee in a common mailing way, such as postal service or personal mailing system, in a form of usually a rectangular flat parcel. The sample retaining sheet may preferably be covered on its both sides with a protective coverage. The protective coverage is provided for facilitation of handling of the sample retaining sheet on collecting the sample, enclosing it in the sample receiving bag 7 and mailing it and may be made of a material chosen in accordance with each specific case adequately among those which are non-permeable and permeable to moisture and gas. For the sample retaining sheet, preference is given to those in which one side is covered by a protective coverage film or sheet non-permeable to moisture and the other side is covered by a protective coverage film or sheet permeable to moisture and gas. The protective coverages disposed on both sides of the sample retaining sheet may preferably be formed together at one end thereof into a hand-holding member or a shank for aid of handling upon collecting the sample to permit handling of the sample retaining sheet by a naked hand without pollution by the sample. As the protective coverage film or sheet non-permeable to moisture, those made of polyolefins, such as polyethylene etc., and polyesters and of composite films of them may be exemplified. As the moisture-and-gas-permeable protective coverage film or sheet, there may favorably be exemplified non-woven fabrics and woven textiles of fibers made of the above-mentioned polymers. The sample receiving bag according to the present invention is constructed so as to receive the sampling unit therein in a state retaining the sample on the sample retaining sheet and is provided with the moisture absorbent so as to keep the sample under a dried condition. Here, it is preferable to construct the sample receiving bag in such a manner that a partition membrane permeable to moisture and gas is interposed between the absorbent and the sampling unit. 8 As the partition membrane, a film or sheet material similar to the gas-permeable film or sheet of the protective coverage film or sheet for protecting the sampling unit may be used. The sampling unit is received in the sample receiving bag so as to confront by its moisture-permeable protective coverage side to the partition membrane in the sample receiving bag. The sample receiving bag may preferably be sealed by using a closure means, such as a double-side tacky adhesive tape or the like. As the moisture absorbent, those which are not reactive with the sample and which do not cause any component in the sample to be denatured but do absorb or adsorb moisture only. For it, a hygroscopic polymer, such as a cross-linked resin based on sodium polyacrylate, may be preferable. While the sample receiving bag enclosing the sampling unit, in which the sample the dried sample for the examination on it, can be sent to the medical examination center as such, it is preferable to mail the sample receiving bag in a form enclosed further in a carrying bag together with an examination data sheet via a conventional mail way, such as postal service. As the examination data sheet, those in which various informations including name, age and pathological case history of the examinee, comment of the doctor in charge and so on can be recorded. An examination data sheet attached to the kit in a form similar to a label or a tag may also be permitted. The method for the medical examination according to the present invention is performed in the 9 following manner: First, the medical examination kit enclosed with a new (freshly prepared) sampling unit, a sample receiving bag and an explanatory document, such as a specification, as well as, if necessary, an examination data sheet is forwarded from the medical examination center to the side of the examinee. Such forwarding can be realized either individually or through an organization, such as a hospital or a medical office. Then, on the side of the examinee, the sample for the examination, such as urine etc., is collected from the examinee by him- or herself or by a protecting person or the like. For collecting a urine sample, urine is once collected in, for example, a paper cup and then the sample retaining sheet of the sampling unit is soaked therein or urine sample can directly be collected by the sample retaining sheet by holding it at its hand-holding shank by a naked hand of the examinee him- or herself without the hand or other handling means being polluted by urine. The sampling unit having the sample retaining sheet now retaining the freshly collected sample for the examination should promptly be enclosed in the sample receiving bag so as to avoid any pollution of the sample by, for example, bacteria, spore of mold in air and not to suffer from bacterial growth causing denature of the sample. The sampling unit should be enclosed in the sample receiving bag in such a posture that the moisture-permeable protective coverage film of the sampling unit will be in opposition to the 10 partition membrane in the sample receiving bag, whereupon the bag is closed by the closure means mentioned above. In the sample receiving bag, moisture present in the sample retained on the sample retaining sheet will permeate through the moisture-permeable protective coverage and the moisture-permeable partition membrane and is absorbed by the moisture absoebent to leave the dried sample. In a dried state, any denaturing of the sample is avoided and any staining or fouling of foreign materials neighboring the sampling kit during its transportation occurs. Thus, the sampling kit can be sent as such or by enclosing it in a carrying bag, to the medical examination center via a common mailing way, such as an ordinary mail of postal service. In the medical examination center, the sampling unit is withdrawn from the sampling kit received and the sample retaining sheet is set in a column and is soaked with distilled water to cause the sample to be extracted out, in order to prepare an analytical sample. While the amount of the sample retained on the sample retaining sheet may be variable, it is able to realize the chemical analysis of the sample wirthout any dependence on the amount of the sample, by determining the composition of constituent components in the sample based on the detected amount of a basal component contained always at a constant proportion in the sample, for example, creatinine in urine sample. According to the present invention, medical examination for diagnosis of possible disease of an 11 examinee can now be realized easily and efficiently without annoying the examinee to visit a hospital or a medical examination center, by mailing a specially constructed mailable sampling kit via a common mailing way, such as an ordinary mail of postal service, wherein the sample for the examination can be collected easily from the examinee using a simple device and the so-collected sample is retained on a special sample retaining sheet in a dried state. THE BEST MODE FOR EMBODYING THE INVENTION Below, the present invention will be described by way of embodiments given in the Drawings appended. In Figs. 1(a) and 2(a), the sampling unit is indicated by the numeral 1, in which a sample retaining sheet 2 consisting of a filter paper is provided on its one side (front side) with a protective coverage film 3 made of a transparent plastic material permeable to gas but impermeable to moisture and on its the other side (rear side) with a protective coverage film 4 permeable to gas and moisture and made of a non-woven fabric of fibers of a plastic material, which coverage films are joined with the sample retaining sheet 2 at junction seam 5 in the lower portion thereof and with each other at junction seams 6 and 7 at both ends thereof each by heat sealing. These coverage films 3 and 4 are arranged to loosely attach to the respective sides of the sample retaining sheet 2 except the junction seam 5. The coverage films 3 and 4 build up a hand-holding shank 8 12 at the lower ends of them between the junction seams 5 and 6. The sample receiving bag 11 shown in Figs. 1(b) and 2(b) is formed from a front side sheet 12 and a rear side sheet 13, which are transparent and moisture-impermeable and which are joind together with a gas-and-moisture-permeable partition membrane 15 made of an unwoven synthetic fabric at a junction seam 16 extending along the peripheral edges at the sides and the bottom thereof by heat sealing under embrace of a sheet 14 made of a moisture absorbent in between the rear side sheet 13 and the partition membrane 15 so as to build up a bag having an internal space 17 for receiving the sampling unit 1. The rear side sheet 13 is joined at its upper edge with the partition membrane 15 by heat sealing to build up a junction seam 16a. The rear side sheet 13 is folded back at the junction seam 16a to form a wrapping lug 18. The front side sheet 12 is provided at its upper peripheral portion with a closure means 19 in a form of, for example, double side tacky adhesive tape, which is covered with a non-adhesive exfoliative tape before the sample has not been received in the bag to prevent unintended sealing of the bag by the wrapping lug 18. The carrying bag 21 shown in Figs. 1(c) and 2(c) is formed from a gas-and-moisture-impermeable tube 22 of plastic material having a size adapted to enclose the sample receiving bag 11 therein by heat sealing one opening thereof into a junction seam 24 to form a bag and by providing the remaining open mouth thereof with 13 a fastener 25 so as to permit closure and opening thereof. The medical examination using the sampling kit according to the present invention as explained above is carried out by the method according to the present invention as illustrated in Fig. 4 in the following manner: First, the sampling unit 1 and the sample receiving bag 11 are enclosed in the carrying bag 21 optionally together with the examination data sheet (not shown) and the carrying bag is sent to the examinee side 32 together with the explanatory specification of the kit. On the side of the examinee 32, the sample for the examination is collected from the examinee by the examinee him- or herself or by any other person. For collecting a sample of, for example, urine, it is permissible to collect it once in, such as, a paper cup and then collect it on the sample retaining sheet 2 or to collect it directly on the sample retaining sheet 2. In both cases, the sample collection can be carried out by holding the hand-holding shank 8 of the sampling unit 1 by one naked hand 9, as shown in Fig. 3(a), and exposing the sample retaining sheet 2 out of the unit by moving- the junction seam 7 on the opposite side end with the other hand towards the direction indicated by the arrow a , whereby the sample collection 33 can be effected under exclusion of any pollution of hands and equipments in an efficient manner. The sampling unit 1 containing the so-collected 14 sample should be enclosed in the sample receiving bag 11 as quick as possible, since it may suffer from growth of bacteria and fungi deposited thereon when standing as such, resulting sometimes in a denaturing of the sample. The sample is enclosed in the sampling unit receiving space 17 of the bag after any drip has been removed but without drying the sampling unit, in such a way that the gas-permeable protective coverage film 4 will be opposite to the partition membrane 15 in the sample receiving bag 11 before folding back and sealing the wrapping lug 18- The exfoliative tape (not shown) covering the double-side tacky adhesive tape of the closure means 19 is then peeled off and the bag is sealed by pressing the wrapping lug 18 onto the tacky adhesive tape of the closure means 19. In this manner, the moisture in the sample retained on the sample retaining sheet 2 will permeate through the moisture-permeable protective coverage 4 and the moisture permeable partition membrane 15 into the moisture absorbent 14 to leave dried sample on the sample retaining sheet 2. In dry state, the constituent components of the sample do neither suffer from denaturing nor can stain other materials neighboring thereto. Thus, by enclosing the sample receiving bag 11 in the carrying bag 21 and closing the carrying bag 21 by the fastener 25, packaging 34 is finished for ready for mailing via a common mailing way, such as ordinary mail of postal service. In the medical examination center 31, the sampling unit 1 is taken out of the received carrying 15 bag 21 sent from the examinee side 32 and is subjected to elution of the sample by extracting it out of the sample retaining sheet 2 using distilled water to prepare an analytical sample for the medical examination. While the amount of the sample retained on the sample retaining sheet 2 may be variable, it is able to realize the chemical analysis of the sample without any dependence on the amount of the sample, by determining the composition of constituent components in the sample based on the detected amount of a basal component contained always at a constant proportion in the sample, for example, creatinine in urine sample. The forwarding and returning of the sampling kit to and from the examinee side may be performed directly to and from the examinee him- or herself or indirectly through an organization, such as a hospital or medical office on the side of the examinee 32. In each case, the sample collection 33 can be realized using the sampling unit 1 by holding it by a naked hand and simply impregnating the sample retaining sheet 2 with the sample without causing pollution of hand and without necessitaing complicate procedures, such as drying of the collected sample. The collected sample is spontaneously be dried by the moisture absorbent incorporated in the sample receiving bag 11 by simply enclosing the sampling unit 1 retaining the collected sample. By using the sampling kit according to the present invention, any denaturing of the sample and any fouling of other materials during the transport of the sampling kit will not occur. 16 Therefore, it is now made possible to carry out mass examination in accurate manner by forwarding and receiving the sampling kits according to the present invention to and from a large number of examinees in any convenient mailing way, such as ordinary mail in postal service. Thus, medical examination of examinees can be realized in an efficient manner in higher accuracy and, in addition, there offers wide occasions to those who are not so much positive to access to medical examinations due to the easier practice of collection of -the examination samples according to the present invention, whereby it contributes to prophylaxis of diseases. In Fig. 3(b), an alternative embodiment of the sampling unit 1 for use in an examinee who uses an accommodation of diaper, such as a baby, is shown, in which the sample retaining sheet 2 is provided on its both sides each a protective coverage sheet 3, 4 made of a non-woven fabric permeable to moisture and gases having a junction seam 6 along the peripheral edge. Also this sampling unit 1 is used in a similar manner as that described above. 17 WE CLAIM : 1. A method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, said method comprising the steps of: forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of: a sampling unit having a sample retaining sheet, and a sample receiving bag, which serves for receiving the sampling unit and is provided with a moisture absorbent, and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit; collecting a sample for the examination, from the examinee, on the sample retaining sheet of the sampling unit in the sampling kit, enclosing in the sample receiving bag the sampling unit, to cause drying of the sample retained on the sample retaining sheet, and returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. 2. A method as claimed in claim 1, wherein the sampling unit has a structure in which both sides of the sample retaining sheet is covered each by a protective coverage. 3. The method as claimed in claim 1 or 2, wherein the sampling kit contains an examination data sheet. -18- 4. A sampling kit to be forwarded from a medical examination center to the side of an examinee and returned therefrom to the medical examination center after a sample for the examination has been collected from the examinee, comprising a sampling unit comprising a sample retaining sheet for retaining the sample collected thereon from the examinee and a sample receiving bag which serves for receiving the sampling unit and is provided with a moisture absorbent and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit. 5. A sampling kit as claimed in claim 4, wherein both sides of the sample retaining sheet are covered each by a protective coverage and the sample retaining sheet and the protective coverages build up together at one end thereof a hand-holding shank. 6. A sampling kit as claimed in claim 4 or 5, wherein the moisture absorbent in a form of sheet is disposed so as to be attached to the sample receiving bag by intermediation by a gas-and-moisture-permeable membrane. 7. Sampling kit, substantially as herein described, particularly with reference to the accompanying drawings. -19- There is disclosed a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, comprising the steps of: forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of: a sampling unit (1) having a sample retaining sheet (2), and a sample receiving bag (11); collecting a sample for the examination, from the examinee, on the sample retaining sheet (2) of the sampling unit (1) in the sampling kit, enclosing in the sample receiving bag (11) the sampling unit (1), to cause drying of the sample retained on the sample retaining sheet, and returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. A sampling kit for the said method is also disclosed.

Full Text

FIELD OF THE INVENTION
The present invention relates to a sampling kit for performing a medical examination of individuals, who are, in particular, not ready or difficult to visit a hospital or a medical examination center or are residing at remote areas, by collecting samples for the medical examination from these individuals in a sampling unit and gathering them at a medical examination center and analyzing them in an appropriate way.
BACKGROUND OF THE INVENTION
It has been practised in general to incorporate a medical examination of an individual to be examined (referred to hereinafter as an examinee), before a possible diagnosis for a disease. Here, it is usual today for such an examinee to visit a hospital or a medical examination center to ask for a medical examination. Request for an examinee to visit hospital or medical examination center may cause sometimes to miss a proper occasion for examining for a disease. In urine analysis, the examinee collects a urine sample in a special vessel, which is then sent to a hospital or a medical examination center in a frozen state and is analyzed there.
1A
By such a practice for medical examination, the collected urine sample exists in liquid state as such and cannot be sent to the hospital or medical examination center by having resort to any conventional mailing way, such as postal service etc., but should rely on restricted transporting means within limited districts, so that medical examination in wide areas using a commonly distributed transporting way has not been able to realize.
On the other hand, there is a demand for performing a mass medical examination for a mass of individuals to be examined for the purpose of achieving an efficient and specialized examination, by gathering the examination samples of them collected personally or in hospitals at a certain medical examination center having expert skills and equipmemts. However, a mass transportation of liquid samples, such as urine and blood, is not favorable in the point of view of possible risk of accidents and damages. Each of the examinees is requested here to forward his or her sample directly to such medical examination center in a specially designed vessel by means of a special mailing means, such as a special postal package.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, wherein the difficulties of the conventional
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practice mentioned above can be avoided by using a sampling kit which serves for collecting one or more examination samples from the examinee and which is capable of being formed into a mailable envelop and by returning the so-formed envelop to a medical examination center for analysis of the sample via a common mailing way without relying on special practices.
Another object of the present invention is to provide the said sampling kit to be used in the method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, mentioned above, which provides for collecting the examination sample(s) from the examinee easily and for being formed into a mailable envelop to be returned as such to the medical examination center via a common mailing way.
Accordingly, the present invention provides :
(1) A method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, said method comprising the steps of:
forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of:
a sampling unit having a sample retaining sheet, and
a sample receiving bag, which serves for receiving the sampling unit and is provided with a moisture absorbent, and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit;
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collecting a sample for the examination, from the examinee, on the sample retaining sheet of the sampling unit in the sampling kit,
enclosing in the sample receiving bag the sampling unit, to cause drying of the sample retained on the sample retaining sheet, and
returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center.
(2) A method as defined in the above (1), wherein the sampling unit has a structure in which both sides of the sample retaining sheet is covered each by a protective coverage.
(3) A method as defined in the above (1) or (2), wherein the sampling kit contains an examination data sheet.
(4) A sampling kit to be forwarded from a medical examination center to the side of an examinee and returned therefrom to the medical examination center after a sample for the examination has been collected from the examinee, comprising
a sampling unit comprising a sample retaining sheet for retaining the sample collected thereon from the examinee and
a sample receiving bag which serves for receiving the sampling unit and is provided with a moisture absorbent and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit.
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(5) A sampling kit as defined in the above (4), wherein both sides of the sample retaining sheet are covered each by a protective coverage and the sample retaining sheet and the protective coverages build up together at one end thereof a hand-holding shank.
(6) A sampling kit as defined in the above (4) or (5), wherein the moisture absorbent in a form of sheet is disposed so as to be attached to the sample receiving bag by intermediation by a gas-and-moisture-permeable membrane.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Figs. 1(a), 1(b) and 1(c) show an embodiment
of the sampling kit according to the present invention,
wherein Figs. 1(a), 1(b) and 1(c) illustrate the
sampling unit, the sample receiving bag and the mailing
envelop, respectively, each in a front view.
Figs. 2(a), 2(b) and 2(c) are the sectional views along the lines A-A, B-B and C-C of Figs. 1(a), 1(b) and 1(c), respectively.
Fig. 3(a) illustrates a state of practical use of an embodiment of the sampling unit in a perspective
view.
Fig. 3(b) shows another embodiment of the sampling unit according to te present invention in a
front view.
Fig. 4 shows the sequence of procedures in
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performing the method for medical examination of an examinee according to the present invention in a flow diagram.
DETAILED DESCRIPTION OF THE INVENTION
There is no limitation as to the disease to be diagnosed using the method for medical examination according to the present invention and there may be included every disease permitting a diagnostic presumption based on the result of analysis of the sample retained on the sample retaining sheet after it has been transported and received by the medical examination center in a dried state, wherein, in particular, diseases based on metabolic disorder, such as diabetes mellitus, gout and diseases based on congenital metabolic disorder, such as phenylketonuria, are enumerated. These diseases and disorders are possible not only for human but also for animals, such as livestock and pets.
There is no restriction as to the substance to be collected as the sample for the medical examination from the examinee and every substance which can be collected from the examinee easily on the side of the examinee and which can be used for medical examination may be chosen as a target substance for the sample, including urine, blood, body fluid and so on, among which urine is enumerated due to easiness in collecting as a liquid sample. By the word "the side of the examinee" or "the examinee side" is meant every one who
6
can perform practical deed of collecting the sample from the examinee and returning it to the medical center and who may be seen by the medical examination center as representative of the examinee, including the examinee him- or herself, kinships, care-attendants, helpers, legal representatives, medical practitioner, nurse and hospital.
The sampling unit according to the present invention comprises a sample retaining sheet. The sample retaining sheet may preferably be made of a material having ample voids and little exudative nature, such as paper, spongy etc., to be served for absorbing and retaining, in particular, a liquid sample for the medical examination, such as urine, blood and body fluids. As a material which is especially not subject to denaturing and is non-exuding, a filter paper used for analytical purpose is favorable. The size of the sample retaining sheet may favorably be suited for retaining an amount of the sample sufficient to carry out the analysis. The sample retaining sheet should have a shape adapted to be enclosed in the sample receiving bag suited for forwarding and returning to and from the examinee in a common mailing way, such as postal service or personal mailing system, in a form of usually a rectangular flat parcel.
The sample retaining sheet may preferably be covered on its both sides with a protective coverage. The protective coverage is provided for facilitation of handling of the sample retaining sheet on collecting the sample, enclosing it in the sample receiving bag
7
and mailing it and may be made of a material chosen in accordance with each specific case adequately among those which are non-permeable and permeable to moisture and gas. For the sample retaining sheet, preference is given to those in which one side is covered by a protective coverage film or sheet non-permeable to moisture and the other side is covered by a protective coverage film or sheet permeable to moisture and gas. The protective coverages disposed on both sides of the sample retaining sheet may preferably be formed together at one end thereof into a hand-holding member or a shank for aid of handling upon collecting the sample to permit handling of the sample retaining sheet by a naked hand without pollution by the sample. As the protective coverage film or sheet non-permeable to moisture, those made of polyolefins, such as polyethylene etc., and polyesters and of composite films of them may be exemplified. As the moisture-and-gas-permeable protective coverage film or sheet, there may favorably be exemplified non-woven fabrics and woven textiles of fibers made of the above-mentioned polymers.
The sample receiving bag according to the present invention is constructed so as to receive the sampling unit therein in a state retaining the sample on the sample retaining sheet and is provided with the moisture absorbent so as to keep the sample under a dried condition. Here, it is preferable to construct the sample receiving bag in such a manner that a partition membrane permeable to moisture and gas is interposed between the absorbent and the sampling unit.
8
As the partition membrane, a film or sheet material similar to the gas-permeable film or sheet of the protective coverage film or sheet for protecting the sampling unit may be used. The sampling unit is received in the sample receiving bag so as to confront by its moisture-permeable protective coverage side to the partition membrane in the sample receiving bag. The sample receiving bag may preferably be sealed by using a closure means, such as a double-side tacky adhesive tape or the like. As the moisture absorbent, those which are not reactive with the sample and which do not cause any component in the sample to be denatured but do absorb or adsorb moisture only. For it, a hygroscopic polymer, such as a cross-linked resin based on sodium polyacrylate, may be preferable.
While the sample receiving bag enclosing the sampling unit, in which the sample the dried sample for the examination on it, can be sent to the medical examination center as such, it is preferable to mail the sample receiving bag in a form enclosed further in a carrying bag together with an examination data sheet via a conventional mail way, such as postal service. As the examination data sheet, those in which various informations including name, age and pathological case history of the examinee, comment of the doctor in charge and so on can be recorded. An examination data sheet attached to the kit in a form similar to a label or a tag may also be permitted.
The method for the medical examination according to the present invention is performed in the
9
following manner:
First, the medical examination kit enclosed with a new (freshly prepared) sampling unit, a sample receiving bag and an explanatory document, such as a specification, as well as, if necessary, an examination data sheet is forwarded from the medical examination center to the side of the examinee. Such forwarding can be realized either individually or through an organization, such as a hospital or a medical office.
Then, on the side of the examinee, the sample for the examination, such as urine etc., is collected from the examinee by him- or herself or by a protecting person or the like. For collecting a urine sample, urine is once collected in, for example, a paper cup and then the sample retaining sheet of the sampling unit is soaked therein or urine sample can directly be collected by the sample retaining sheet by holding it at its hand-holding shank by a naked hand of the examinee him- or herself without the hand or other handling means being polluted by urine.
The sampling unit having the sample retaining sheet now retaining the freshly collected sample for the examination should promptly be enclosed in the sample receiving bag so as to avoid any pollution of the sample by, for example, bacteria, spore of mold in air and not to suffer from bacterial growth causing denature of the sample. The sampling unit should be enclosed in the sample receiving bag in such a posture that the moisture-permeable protective coverage film of the sampling unit will be in opposition to the
10
partition membrane in the sample receiving bag, whereupon the bag is closed by the closure means mentioned above.
In the sample receiving bag, moisture present in the sample retained on the sample retaining sheet will permeate through the moisture-permeable protective coverage and the moisture-permeable partition membrane and is absorbed by the moisture absoebent to leave the dried sample. In a dried state, any denaturing of the sample is avoided and any staining or fouling of foreign materials neighboring the sampling kit during its transportation occurs. Thus, the sampling kit can be sent as such or by enclosing it in a carrying bag, to the medical examination center via a common mailing way, such as an ordinary mail of postal service.
In the medical examination center, the sampling unit is withdrawn from the sampling kit received and the sample retaining sheet is set in a column and is soaked with distilled water to cause the sample to be extracted out, in order to prepare an analytical sample. While the amount of the sample retained on the sample retaining sheet may be variable, it is able to realize the chemical analysis of the sample wirthout any dependence on the amount of the sample, by determining the composition of constituent components in the sample based on the detected amount of a basal component contained always at a constant proportion in the sample, for example, creatinine in urine sample.
According to the present invention, medical examination for diagnosis of possible disease of an
11
examinee can now be realized easily and efficiently without annoying the examinee to visit a hospital or a medical examination center, by mailing a specially constructed mailable sampling kit via a common mailing way, such as an ordinary mail of postal service, wherein the sample for the examination can be collected easily from the examinee using a simple device and the so-collected sample is retained on a special sample retaining sheet in a dried state.
THE BEST MODE FOR EMBODYING THE INVENTION
Below, the present invention will be described by way of embodiments given in the Drawings appended.
In Figs. 1(a) and 2(a), the sampling unit is indicated by the numeral 1, in which a sample retaining sheet 2 consisting of a filter paper is provided on its one side (front side) with a protective coverage film 3 made of a transparent plastic material permeable to gas but impermeable to moisture and on its the other side (rear side) with a protective coverage film 4 permeable to gas and moisture and made of a non-woven fabric of fibers of a plastic material, which coverage films are joined with the sample retaining sheet 2 at junction seam 5 in the lower portion thereof and with each other at junction seams 6 and 7 at both ends thereof each by heat sealing. These coverage films 3 and 4 are arranged to loosely attach to the respective sides of the sample retaining sheet 2 except the junction seam 5. The coverage films 3 and 4 build up a hand-holding shank 8
12
at the lower ends of them between the junction seams 5 and 6.
The sample receiving bag 11 shown in Figs. 1(b) and 2(b) is formed from a front side sheet 12 and a rear side sheet 13, which are transparent and moisture-impermeable and which are joind together with a gas-and-moisture-permeable partition membrane 15 made of an unwoven synthetic fabric at a junction seam 16 extending along the peripheral edges at the sides and the bottom thereof by heat sealing under embrace of a sheet 14 made of a moisture absorbent in between the rear side sheet 13 and the partition membrane 15 so as to build up a bag having an internal space 17 for receiving the sampling unit 1. The rear side sheet 13 is joined at its upper edge with the partition membrane 15 by heat sealing to build up a junction seam 16a. The rear side sheet 13 is folded back at the junction seam 16a to form a wrapping lug 18. The front side sheet 12 is provided at its upper peripheral portion with a closure means 19 in a form of, for example, double side tacky adhesive tape, which is covered with a non-adhesive exfoliative tape before the sample has not been received in the bag to prevent unintended sealing of the bag by the wrapping lug 18.
The carrying bag 21 shown in Figs. 1(c) and 2(c) is formed from a gas-and-moisture-impermeable tube 22 of plastic material having a size adapted to enclose the sample receiving bag 11 therein by heat sealing one opening thereof into a junction seam 24 to form a bag and by providing the remaining open mouth thereof with
13
a fastener 25 so as to permit closure and opening thereof.
The medical examination using the sampling kit according to the present invention as explained above is carried out by the method according to the present invention as illustrated in Fig. 4 in the following manner:
First, the sampling unit 1 and the sample receiving bag 11 are enclosed in the carrying bag 21 optionally together with the examination data sheet (not shown) and the carrying bag is sent to the examinee side 32 together with the explanatory specification of the kit.
On the side of the examinee 32, the sample for the examination is collected from the examinee by the examinee him- or herself or by any other person. For collecting a sample of, for example, urine, it is permissible to collect it once in, such as, a paper cup and then collect it on the sample retaining sheet 2 or to collect it directly on the sample retaining sheet 2. In both cases, the sample collection can be carried out by holding the hand-holding shank 8 of the sampling unit 1 by one naked hand 9, as shown in Fig. 3(a), and exposing the sample retaining sheet 2 out of the unit by moving- the junction seam 7 on the opposite side end with the other hand towards the direction indicated by the arrow a , whereby the sample collection 33 can be effected under exclusion of any pollution of hands and equipments in an efficient manner.
The sampling unit 1 containing the so-collected
14
sample should be enclosed in the sample receiving bag 11 as quick as possible, since it may suffer from growth of bacteria and fungi deposited thereon when standing as such, resulting sometimes in a denaturing of the sample. The sample is enclosed in the sampling unit receiving space 17 of the bag after any drip has been removed but without drying the sampling unit, in such a way that the gas-permeable protective coverage film 4 will be opposite to the partition membrane 15 in the sample receiving bag 11 before folding back and sealing the wrapping lug 18- The exfoliative tape (not shown) covering the double-side tacky adhesive tape of the closure means 19 is then peeled off and the bag is sealed by pressing the wrapping lug 18 onto the tacky adhesive tape of the closure means 19.
In this manner, the moisture in the sample retained on the sample retaining sheet 2 will permeate through the moisture-permeable protective coverage 4 and the moisture permeable partition membrane 15 into the moisture absorbent 14 to leave dried sample on the sample retaining sheet 2. In dry state, the constituent components of the sample do neither suffer from denaturing nor can stain other materials neighboring thereto. Thus, by enclosing the sample receiving bag 11 in the carrying bag 21 and closing the carrying bag 21 by the fastener 25, packaging 34 is finished for ready for mailing via a common mailing way, such as ordinary mail of postal service.
In the medical examination center 31, the sampling unit 1 is taken out of the received carrying
15
bag 21 sent from the examinee side 32 and is subjected to elution of the sample by extracting it out of the sample retaining sheet 2 using distilled water to prepare an analytical sample for the medical examination. While the amount of the sample retained on the sample retaining sheet 2 may be variable, it is able to realize the chemical analysis of the sample without any dependence on the amount of the sample, by determining the composition of constituent components in the sample based on the detected amount of a basal component contained always at a constant proportion in the sample, for example, creatinine in urine sample.
The forwarding and returning of the sampling kit to and from the examinee side may be performed directly to and from the examinee him- or herself or indirectly through an organization, such as a hospital or medical office on the side of the examinee 32. In each case, the sample collection 33 can be realized using the sampling unit 1 by holding it by a naked hand and simply impregnating the sample retaining sheet 2 with the sample without causing pollution of hand and without necessitaing complicate procedures, such as drying of the collected sample. The collected sample is spontaneously be dried by the moisture absorbent incorporated in the sample receiving bag 11 by simply enclosing the sampling unit 1 retaining the collected sample. By using the sampling kit according to the present invention, any denaturing of the sample and any fouling of other materials during the transport of the sampling kit will not occur.
16
Therefore, it is now made possible to carry out mass examination in accurate manner by forwarding and receiving the sampling kits according to the present invention to and from a large number of examinees in any convenient mailing way, such as ordinary mail in postal service. Thus, medical examination of examinees can be realized in an efficient manner in higher accuracy and, in addition, there offers wide occasions to those who are not so much positive to access to medical examinations due to the easier practice of collection of -the examination samples according to the present invention, whereby it contributes to prophylaxis of diseases.
In Fig. 3(b), an alternative embodiment of the sampling unit 1 for use in an examinee who uses an accommodation of diaper, such as a baby, is shown, in which the sample retaining sheet 2 is provided on its both sides each a protective coverage sheet 3, 4 made of a non-woven fabric permeable to moisture and gases having a junction seam 6 along the peripheral edge. Also this sampling unit 1 is used in a similar manner as that described above.
17
WE CLAIM :
1. A method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, said method comprising the steps of:
forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of:
a sampling unit having a sample retaining sheet, and
a sample receiving bag, which serves for receiving the sampling unit and is provided with a moisture absorbent, and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit;
collecting a sample for the examination, from the examinee, on the sample retaining sheet of the sampling unit in the sampling kit,
enclosing in the sample receiving bag the sampling unit, to cause drying of the sample retained on the sample retaining sheet, and
returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center.
2. A method as claimed in claim 1, wherein the sampling unit has a structure in which both sides of the sample retaining sheet is covered each by a protective coverage.
3. The method as claimed in claim 1 or 2, wherein the sampling kit contains an examination data sheet.
-18-
4. A sampling kit to be forwarded from a medical examination center to the side of an examinee and returned therefrom to the medical examination center after a sample for the examination has been collected from the examinee, comprising
a sampling unit comprising a sample retaining sheet for retaining the sample collected thereon from the examinee and
a sample receiving bag which serves for receiving the sampling unit and is provided with a moisture absorbent and which contains a partition membrane permeable to gas and moisture disposed between the moisture absorbent and the sampling unit.
5. A sampling kit as claimed in claim 4, wherein both sides of the sample retaining sheet are covered each by a protective coverage and the sample retaining sheet and the protective coverages build up together at one end thereof a hand-holding shank.
6. A sampling kit as claimed in claim 4 or 5, wherein the moisture absorbent in a form of sheet is disposed so as to be attached to the sample receiving bag by intermediation by a gas-and-moisture-permeable membrane.
7. Sampling kit, substantially as herein described, particularly with reference to the accompanying drawings.
-19-
There is disclosed a method of transporting a diagnostic sample, collected from an examinee, to a medical examination center, while keeping the sample preserved in the same state, comprising the steps of:
forwarding a sampling kit from a medical examination center to the examinee side, said sampling kit being constituted of:
a sampling unit (1) having a sample retaining sheet (2), and
a sample receiving bag (11);
collecting a sample for the examination, from the examinee, on the sample retaining sheet (2) of the sampling unit (1) in the sampling kit,
enclosing in the sample receiving bag (11) the sampling unit (1), to cause drying of the sample retained on the sample retaining sheet, and
returning the sampling kit via a conventional mailing way to the medical examination center, for analyzing the dried sample, as retained on the sample retaining sheet in the so-returned sampling kit, at the medical examination center. A sampling kit for the said method is also disclosed.

Documents:

00579-cal-1999 abstract.pdf

00579-cal-1999 claims.pdf

00579-cal-1999 correspondence.pdf

00579-cal-1999 description(complete).pdf

00579-cal-1999 drawings.pdf

00579-cal-1999 form-1.pdf

00579-cal-1999 form-18.pdf

00579-cal-1999 form-2.pdf

00579-cal-1999 form-3.pdf

00579-cal-1999 form-5.pdf

00579-cal-1999 g.p.a.pdf

00579-cal-1999 letters patent.pdf

00579-cal-1999 otherts document.pdf

00579-cal-1999 priority document others.pdf

00579-cal-1999 reply f.e.r.pdf

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Patent Number

206421

Indian Patent Application Number

579/CAL/1999

PG Journal Number

17/2007

Publication Date

27-Apr-2007

Grant Date

27-Apr-2007

Date of Filing

25-Jun-1999

Name of Patentee

MILLS: MATSUMOTO INSTITUTE OF LIFE SCIENCE

Applicant Address

NI 65-1, OTOMO-MACHI, KANAZAWA-SHI, ISHIKAWA 920-0222, JAPAN.

Inventors:

#	Inventor's Name	Inventor's Address
1	MATSUMOTO ISAMU	C/O MILLS: MATSUMOTO INSTITUTE OF LIFE SCIENCE, NI 65-1, OTOMO-MACHI, KANAZAWA-SHI, ISHIKAWA 920-0222 JAPAN.
2	ZHANG CHUNHUA	C/O MILLS: MATSUMOTO INSTITUTE OF LIFE SCIENCE, NI 65-1, OTOMO-MACHI, KANAZAWA-SHI, ISHIKAWA 920-0222 JAPAN.

PCT International Classification Number

A61B 5/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	37888/1999	1999-02-16	Japan