Abstract:
“A collection device for self-collecting bodily substances can take the form of a sanitary napkin comprising a porous outer sleeve opened at one end thereof and including upper and lower sheets. The lower sheet is outwardly provided with an impermeable sheet coated with an adhesive covered with a removable protective peel-off strip. The sanitary napkin comprises between the upper and lower sheets an absorbent layer and a removable sampling filter. The filter is slidably received in the outer sleeve, extends between the upper sheet and the absorbent layer and is removable from the sanitary napkin once bodily substances have collected thereon for being then sealingly packaged and stored until its analysis. The sampling strip can also be made more or less integral with the sanitary napkin such that the complete napkin is forwarded by the end user to the laboratory.”

Description:
This application is a Continuation of application Ser. No. 08/668,894, filed Jun. 24, 1996 now U.S. Pat. No. 5,876,389. 
    
    
     BACKGROUND OF INVENTION 
     1. Field of the Invention 
     The present invention relates to collection devices for recovering samples of bodily fluids or cells for subsequent laboratory analysis and, more particularly, to a collection device and method for allowing the patient to recover samples of bodily fluids, secretions, cells, and infectious and non-infectious agents, in whole all hereinafter referred to as bodily substances, and, for instance, to a modified sanitary napkin for collecting such substances from the genital, anal or urinary regions, and to a method associated with the use thereof. 
     2. Description of Prior Art 
     U.S. Pat. No. 5,231,992 issued on Aug. 3, 1993 to Leon discloses a low-impact cervical cell and fluid collector which includes a substantially disc-shaped main body  12  which defines a generally concave recess  14  into which a porous collection membrane  16  is mounted. Therefore, when the collector  10  is in place adjacent to the patient&#39;s cervix, cells and fluids adhere to the outer surface of the membrane  16 . Underneath the membrane  16 , there is provided a layer  24  of a cell-moistening material or agent, such as a polymer gel adapted to release water during cell collection for moistening collected cells through the pores of the membrane  16  when the cells are adhered to the outer surface thereof. The main body  12  can be provided with a string  18  to facilitate the removal of the collector  10  from the body. 
     French Patent Application which was published as FR-2 599 500 on Dec. 4, 1987 in the name of Chieusse discloses a transparent adhesive strip for taking a sample directly from the skin&#39;s surface for microscopic examination or analysis, the adhesive strip comprising a rigid transparent resin or glass plate  1  covered successively with a transparent layer  2  which is self-adhesive on both of its sides, an isolating film or coating  4  of shorter length, and a semi-rigid cover layer  3  made, for instance, of strong paper or cardboard. The limited length of the film  4  defines a section  5  where the cover layer  3  adheres directly to the adhesive  2  and forms a joint line  6  which allows for the cover layer  3  to be pivotally lifted about the hinge  6 , wherein in a closed position  7 , the sample-taking surface  9  is protected for its transport or storage, whereas in its open position  8 , the adhesive surface  2  can be brought into direct contact with the skin&#39;s surface such as to enable the adhesive strip  2  to remove and collect desired samples from the skin and other surfaces for subsequent analysis thereof. 
     U.S. Pat. No. Re. 24,666 issued on Jul. 7, 1959 to Draghi discloses a tampon for the detection of cancer of the pelvic region. More particularly, the tampon of this U.S. Patent constitutes a preliminary diagnosis method which determines if there are present any indicia of cancer by taking a sample of cells which are present in the cervical canal and in the vagina and by the subsequent microscopic analysis of these cells. The tampon includes a tampon body  10  partly covered by a jacket  12  terminating with an enlarged cap  13  and, at the other end of the tampon body  10 , there is provided a string  22 . The assembly of the body  10  and jacket  12  forms a detection tampon  14 . The enlarged cap  13  which closes one end of the tampon  14  is adapted to extend farthest into the vaginal canal and to collect and retain in moist form cells thereof. The jacket  12  also collects cells and retains them in a relatively moist condition thereby ensuring a more accurate clinical evaluation. 
     U.S. Pat. No. 3,850,160 issued on Nov. 26, 1974 to Denson discloses a diagnostic tampon  10  having a supporting body  13  covered by an outer film  12  and provided at one end thereof with a removal string  11 . The tampon is particularly adapted for collecting cellular material from body cavities, in particular from the vaginal cavity, for subsequent examination. 
     U.S. Pat. No. 5,432,097 issued on Jul. 11, 1995 to Yourno teaches a method for the recovery of blood cells from dried blood spots on a filter paper. 
     U.S. Pat. No. 5,119,828 issued on Jun. 9, 1992 to Miller discloses a device  10  for collecting sebum which is secreted by the sebaceous glands of a patient, the device  10  including a microporous film  12  which is opaque to light when the pores are filled with gaseous material and which is substantially translucent when the film pores are filled with sebum. The film  12  is mounted to a substrate  14  which defines a light absorbing area  16  for enhancing visualization of the pores of the film  12  when filled with sebum. In use, the device is pressed against the patient&#39;s skin surface such that the film  12  contacts the skin and absorbs its sebum, whereby a sebum spot pattern is developed in the film  12  and is visually enhanced by way of the light absorbing area  16 . 
     U.S. Pat. No. 5,088,502 issued on Feb. 18, 1992 to Miller discloses a device  10  for sampling the surface of the skin which includes a substrate  12  having a light absorbing area  14  disposed thereon with an adhesive layer  16  being disposed on the substrate  12  such as to overlie the light absorbing area  14 . The adhesive layer  16  is optically clear and under pressure conforms to the surface of the skin to be sampled. A removable protective film  18  provided with a tab  20  is disposed on the adhesive layer  16  for protecting the same prior to use of the device. The device and, more particularly, the adhesive layer  16  is placed against the skin surface such that, when removed, skin cells adhere to the adhesive layer  16 . The sampled cells can then be visualized in view of the light absorbing area  14 . 
     U.S. Pat. No. 4,789,629 issued on Dec. 6, 1988 to Baker et al teaches a device for collecting and testing fecal occult blood which includes a pocket-like member  16  and an absorbent insert  24  disposed in the pocket member  16 . The pocket member  16  is disposed on the inside front cover of the device such that when the cover is in a closed position thereof, the pocket  16  overlies the fecal smear on the specimen receiving sheet  36 , whereby with one single collection, two separate membranes, that is the specimen receiving sheet  36  and the absorbent insert  24 , receive the components of the fecal sample and can be individually and independently tested. 
     U.S. Pat. No. 4,808,379 issued on Feb. 28, 1989 to Wardlaw et al discloses a device for obtaining stool samples and detecting occult blood and which is used in a way similar to toilet tissue to obtain a stool sample on a receptor sheet  26  provided in the device. Therefore, to obtain the stool sample, the patient, after defecation, draws the cover sheet  32  and its holes  34  across the rectum in the same manner as toilet tissue such that stool is thus wiped onto the cover sheet and passes through the openings  34  and deposits in spots on the receptor sheet  26 . The cover sheet  32  is then peeled off and discarded, thereby exposing the stool spots S of the receptor sheet  26 , after which the stool spots S can be effectively sealed in the device by folding the impermeable sheet  2 . 
     SUMMARY OF INVENTION 
     It is therefore an aim of the present invention to provide an improved device for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc. 
     It is also an aim of the present invention to provide an improved method for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc. 
     It is a further aim of the present invention to provide a modified sanitary napkin for collecting samples of bodily substances from the genital, anal or urinary regions and, for instance, vaginal secretions. 
     It is a still further aim of the present invention to provide a modified sanitary napkin provided with an absorbent layer for collecting the samples of bodily substances from the genital, anal or urinary regions. 
     It is a still further aim of the present invention to provide a collection device, such as a modified sanitary napkin, having a removable collection strip, membrane or filter, in particular in the form of an absorbent strip, slidably received in a pocket defined in the collection device or sanitary napkin. 
     Therefore, in accordance with the present invention, there is provided a collection device for collecting bodily substances from the genital, anal or urinary regions, comprising a substantially flexible and comfortable member adapted to be positioned such that a receiving surface of said member is located substantially opposite a location from which a sample of bodily substance is to be taken, collecting means in said member and in communication with said receiving surface, whereby sufficient bodily substance contacting said receiving surface is at least partly collected by said collecting means for subsequent analysis thereof. 
     Also in accordance with the present invention, there is provided a collection device for allowing a user to collect bodily substances, comprising a member adapted to be externally worn by the user such that a receiving surface of said member is located substantially opposite a location of the user at which a sample of bodily substance is to be taken, collecting means in said member and in communication with said receiving surface, said collecting means being removable from said member by the user, whereby once sufficient bodily substance having contacted said receiving surface has been at least partly collected by said collecting means, said collecting means is removed from said member for subsequent analysis thereof. 
     Further in accordance with the present invention, there is provided a method of self-collection of bodily substances, comprising the steps of: 
     (a) self-positioning collector means externally on a user and at a location of the user at which a sample of bodily substance is to be taken; and 
     (b) collecting on said collector means at least one bodily substance from the user. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Having thus generally described the nature of the invention, reference will now be made to the accompanying drawings, showing by way of illustration a preferred embodiment thereof, and in which: 
     FIG. 1 is a perspective view of a modified sanitary napkin in accordance with the present invention; 
     FIG. 2 is a perspective view of the sanitary napkin of FIG. 1 but illustrated with its removable absorbent sampling strip partly removed therefrom; 
     FIG. 3 is a transversal cross-sectional view taken along line  3 — 3  of FIG. 2; and 
     FIG. 4 is a longitudinal cross-sectional view taken along line  4 — 4  of FIG.  1 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is concerned with the collection of samples of bodily substances (such as fluids, secretions, cells, microorganisms, infectious and non-infectious agents, etc.) and, more particularly, in view of some people&#39;s reticence in having these samples taken at a clinic or hospital, with a collection device and method which allow the patient to “self-collect” the samples, typically outside of any formal medical environment, which can then be properly packaged and forwarded for subsequent analysis thereof to any appropriate medical facility, e.g. laboratory. 
     In the present description as well as in the appended claims, the terms “substance” and “substances” are understood to include any bodily fluids, secretions, cells, microorganisms, infectious and non-infectious agents, etc., which can be externally recovered from the body. 
     For instance, and in accordance with the present invention, FIG. 1 illustrates a modified sanitary napkin N which is intended for collecting substances at the genital and anal regions and which includes a porous outer sleeve  10  having upper and lower sheets  12  and  14 , respectively, which are joined at a first longitudinal end  16  thereof and which are open at an opposite second longitudinal end  18  of the sleeve  10 . The upper and lower sheets  12  and  14  are at least partly made of a porous fabric, typically in the form of a close knit netting. Inside the sleeve  10 , there is provided an absorbent layer  20 , of the type well known in the art of sanitary napkins. The absorbent layer  20  is peripherally secured to the upper and lower sheets  12  and  14  of the porous sleeve  10 , apart from at the second end  18  where the absorbent layer  20  is typically only secured to the lower sheet  14  such that the opening at the second end  18  is defined between the upper sheet  12  and the absorbent layer  20 , as best seen in FIG.  4 . 
     Under or outwardly of the lower sheet  14 , an insulating or impermeable layer  22  acting as a liquid impervious barrier is mounted to the lower sheet  14  and is provided with an adhesive coating on a side of the impermeable layer  22  opposite its side secured to the lower sheet  14  of the sleeve  10 . A removable strip  24  is detachably mounted to the adhesive coating of the impermeable layer  22  such that it can be removed therefrom when the sanitary napkin N is to be attached to an undergarment. 
     Intermediate the upper sheet  12  of the sleeve  10  and the absorbent layer  20 , a removable absorbent sampling filter or strip  26  is slidably received in a pocket  28  which is defined between the upper sheet  12  and the absorbent layer  20  and which is open at the second end  18 , again as best seen in FIG.  4 . The sampling strip  26  is provided at an outside end thereof with a handling tab  30 . The sampling strip  26  can be made, for instance, of a semi-porous and absorbent material, e.g. a sheet-like filter made of paper, of synthetic or non-synthetic fabrics, etc., such as to allow the patient to collect substances, for instance vaginal secretions, as samples for subsequent analysis thereof in a laboratory or the like while allowing for excess secretions and fluids to pass therethrough and reach the absorbent layer  20  and to be collected thereon. 
     In the present embodiment of the invention which takes the form of the sanitary napkin N, the description might refer to vaginal secretions instead of the more general “substances” mentioned hereinabove, but this is only done for illustration purposes, that is as an example of a use of the present sanitary napkin N and is obviously not intended to restrict the scope of use of any collection device in accordance with the present invention to the single collection of vaginal secretion samples. 
     More particularly, in use, the sanitary napkin N has the form generally shown in FIG. 1 with its removable strip  24  being removed therefrom such as to allow the sanitary napkin N to be attached to an undergarment. Subsequently, vaginal secretions, for example, will come into contact with the sanitary napkin N and, more particularly, with the upper sheet  12  of the sleeve  10  thereof. Through the netting of the upper sheet  12 , the vaginal secretions will then reach the sampling strip  26 , whereat some of the secretions will be absorbed and retained by the sampling strip  26  with the remainder of the secretions filtering therethrough and reaching the absorbent layer  20 . Therefore, a sampling of vaginal secretions will have collected on the sampling strip  26  which, before the sanitary napkin N is discarded, is removed from the sanitary napkin N as per arrow  32  of FIG. 2, whereby the sampling strip  26  can then be properly packaged and sent, for instance, to a laboratory to be analyzed. 
     Therefore, the sanitary napkin N of the present invention which is intended to facilitate and render more accessible the uncovering, for example, of sexually transmitted diseases by reducing some people&#39;s resistance to showing up at clinics to be tested by way of the collection of samples for analysis purposes, is considered to meet this object as, clearly, the simple use in a typically well-known fashion of a substantially recognizable sanitary napkin N will allow for a proper sampling of bodily substances, such as vaginal secretions, to be easily obtained and forwarded to a laboratory, using the present absorbent sampling strip or filter  26  as a collection medium which is typically sealed in an appropriate container once it has been removed from the sanitary napkin N. and until it is ready to be analyzed in the laboratory. 
     In the laboratory, the sampling filter  26  can be analyzed by way of known techniques, such as polymerase chain reaction (PCR) and ligase chain reaction (LCR) techniques, etc. 
     Accordingly, the present sanitary napkin N which is based on modifications made to conventional sanitary napkins can be easily used by the patient as a collection and reception medium for various substances (e.g. secretions) provided externally of the genital, anal or urinary regions, from which a sample can then be obtained by removing the sampling strip  26  from the sanitary napkin N. 
     The present invention also contemplates having a non-removable, i.e. at the level of the end user, sampling filter strip or collector installed in the sanitary napkin, whereby the complete sanitary napkin would be sent to the laboratory, whereat it would be appropriately dismantled to retrieve its sampling strip for the analysis thereof. 
     Furthermore, by the present invention, there is also provided a method of collecting samples of bodily substances, such as of secretions emitted at the genital, anal or urinary regions, by providing a collection medium which is adapted to be positioned at an appropriate location, for instance in the undergarment, and externally of the user, and which is further adapted to receive and/or collect samples of bodily substances, the samples being then typically properly packaged for the subsequent analysis thereof. 
     The present collection device, which has been herein preferably shown and described in the form of the sanitary napkin N for collecting vaginal secretions, as well as the present collection method can obviously be also used to collect various other bodily substances, such as biological fluids, blood, tissues, microorganisms or cells (again all herein generally referred to as substances), for instance, from the genito-urinary tract or system and/or from the anal region. 
     Accordingly, various applications of the collection device are foreseen, such as (1) for the analysis of products accumulated in the sampling filter or strip  26 , including research on and identification of infectious agents (e.g. chlamydia, HIV, gonorrhea, herpes, cytomegalovirus, human papillomavirus, mycoplasma, ureaplasma, candida and other infectious and non-infectious agents, etc.) or parasites (e.g. trichomonas) or any other biochemical particle or component originating from these agents with a view of identifying and treating these agents by known techniques as well as by techniques which will be developed; (2) for the analysis of cells from the genito-urinary or intestinal system for the chromosomal, histological, cytological, biochemical or biomolecular analysis thereof; (3) for the analysis of the menstrual blood, or its derivatives (e.g. antibodies) and of any other molecule detected in the sampling strip  26 ; (4) for the analysis of urine, of its derivatives and of any other molecule originating from the urinary system and detected in the sampling strip  26 ; and (5) for the analysis of products derived from the pilosebaceous system of the genital, anal and cutaneous sphere; etc. 
     Basically, the invention is intended to enable the patient to recover samples of secretions, fluids, etc. emitted from the body, as well as samples of cells, fluids, etc. which are present at the cutaneous level (e.g. for the collection of substances from sores, etc., such as in the case of some types of herpetic infections which manifest on the skin) and to sealingly package the collected samples which can then be forwarded to a laboratory for the analysis thereof.