FIELD OF THE INVENTION

[001] The present invention relates to a device, system and method of collection of urine samples. More particularly, the present invention relates to devices, systems and methods for collection of urine samples from infants without contamination of the samples.

BACKGROUND OF THE INVENTION

[002] Febrile infants examined by a physician might be diagnosed with a Urinary Tract Infection (UTI). According to medical guidelines, diagnosis of UTI in an infant requires taking a urine sample for culture and analysis. Currently, there are various methods for urine collection, including invasive procedures such as catheterization and suprapubic aspiration with insertion of a needle into the bladder, which are usually carried out at the hospital.

[003] Some non-invasive procedures include the "clean-catch" method, wherein the mid-stream urine (being the portion without initial part of urine coming out) is collected into a plastic container held up in front of the child, specifically for male infants and adults. However, this option is not applicable to female infants considering the female anatomy, since it is not practical to selectively collect only the mid-stream portion of the urine.

[004] With the pediatric urine collection bag method, the urine is collected into a bag through a circular opening, held in place by a surrounding strip of adhesive. This method has been reported as inefficient, time consuming and inconvenient by both parents and medical staff. The adhesive strip often fails to hold the contraption in place, and the process generally requires several attempts. Furthermore, despite sterilization of the area, the rate of sample contamination is about 60-70%, since the urine is in contact with the skin or diaper.

[005] Therefore, presently there is no effective non- invasive solution for collecting a urine sample from female infants without contamination of the samples.

SUMMARY OF THE INVENTION

[006] There is thus provided, in accordance with a preferred embodiment of the invention, a device for non-invasive urine collection from a female patient, the device comprising a confinement segment, configured to allow confinement of the urethra orifice of the patient from surrounding tissue, a fastening segment coupled to the confinement segment, and configured to allow fastening of the device to the pelvis of the patient, at least one liquid collection chamber in fluid connection to the confinement segment, and configured to allow collection of urine, and a flow routing mechanism, configured to allow routing of urine into the at least one liquid collection chamber.

[007] In some embodiments, the fastening segment may comprise a perforated patch that is configured to allow flow of urine through a perforation of the patch. In some embodiments, the patch may comprise a bio-compatible pressure sensitive adhesive. In some embodiments, the patch may comprise elastic material. In some embodiments, the fastening segment may comprise an adhesive material.

[008] In some embodiments, the device may further comprise a liquid absorbing material coupled to the confinement segment and configured to allow absorption of urine flowing outside of the flow routing mechanism.

[009] In some embodiments, the at least one liquid collection chamber may be further configured to allow isolation and separation of preliminary urine. In some embodiments, the at least one liquid collection chamber may be further configured to allow collection of midstream urine.

[0010] In some embodiments, the confinement segment may be configured to allow separation of the labia from the urethra orifice of the patient. In some embodiments, the device may be embedded into a diaper. In some embodiments, the fastening segment may comprise a stability harness. In some embodiments, the flow routing mechanism may further comprise a one-way valve configured to allow flow into the at least one liquid collection chamber.

[0011] In some embodiments, the at least one liquid collection chamber may comprise an over flow flush valve that is configured to flush liquid in case that an amount of accumulated liquid is greater than a predefined threshold.

[0012] In some embodiments, the at least one liquid collection chamber may comprise a first liquid collection chamber configured to allow collection of preliminary urine, and a second liquid collection chamber configured to allow collection of midstream urine.

[0013] In some embodiments, the flow routing mechanism may be configured to allow flow into the first liquid collection chamber until a predetermined amount of liquid is collected, and also configured to allow flow into the second liquid collection chamber when the predetermined amount of liquid is collected in the first liquid collection chamber.

[0014] In some embodiments, the flow routing mechanism may comprise a first one-way valve coupled to the first liquid collection chamber, and a second one-way valve coupled to the first liquid collection chamber.

[0015] In some embodiments, the first one-way valve may be closed when the predetermined amount of liquid is collected in the first liquid collection chamber. In some embodiments, the second one-way valve may be opened when the predetermined amount of liquid is collected in the first liquid collection chamber. In some embodiments, the predetermined amount of liquid is 2-5 milliliters.

[0016] In some embodiments, the first liquid collection chamber may comprise absorbent material, and wherein presence of liquid in the first liquid collection chamber changes the volume therein due to a change in the volume of the absorbent material.

[0017] In some embodiments, a change in the volume of the first liquid collection chamber may be configured to allow diversion of flow into the second liquid collection chamber. In some embodiments, the second liquid collection chamber may comprise collapsing material, and wherein presence of liquid at the first liquid collection chamber diverts flow into the second liquid collection chamber,

[0018] In some embodiments, the first liquid collection chamber may be separable from the second liquid collection chamber. In some embodiments, the second liquid collection chamber may be accommodated within the first liquid collection chamber.

[0019] In some embodiments, the device may further comprise at least one sensor configured to allow analyzing of urine within the at least one liquid collection chamber. In some embodiments, the device may further comprise an inflatable segment coupled to the confinement segment, and configured to allow routing flow into the flow routing mechanism upon inflation.

[0020] Furthermore, in accordance with a preferred embodiment of the present invention, a method of collecting urine from a female patient is provided, the method comprising confining the urethra orifice of the patient from surrounding tissue, fastening at least one liquid collection chamber to the patient, routing urine into the at least one liquid collection chamber with a flow routing mechanism, separating preliminary urine flow from midstream urine, and removing the collected urine sample with the midstream urine.

[0021] In some embodiments, the method may further comprise separating and isolating the labia from the urethra orifice of the patient. In some embodiments, the confining may comprise passing urine through a perforated patch.

[0022] In some embodiments, the method may further comprise absorbing urine flowing outside of the flow routing mechanism. In some embodiments, the method may further comprise isolating the preliminary urine.

[0023] In some embodiments, the method may further comprise flushing liquid from the at least one liquid collection chamber in case that an amount of accumulated liquid is greater than a predefined threshold. [0024] In some embodiments, the flow routing mechanism may be configured to allow flow into a first liquid collection chamber until a predetermined amount of liquid is collected, and also configured to allow flow into a second liquid collection chamber when the predetermined amount of liquid is collected in the first liquid collection chamber.

[0025] In some embodiments, the flow routing mechanism may comprise a first one-way valve coupled to the first liquid collection chamber, and a second one-way valve coupled to the first liquid collection chamber, and the method further comprising closing the first one-way valve when the predetermined amount of liquid is collected in the first liquid collection chamber.

[0026] In some embodiments, the method may further comprise opening the second one-way valve when the predetermined amount of liquid is collected in the first liquid collection chamber. In some embodiments, the method may further comprise analyzing urine within the at least one liquid collection chamber with at least one sensor. In some embodiments, the method may further comprise inflating an inflatable segment coupled to the at least one liquid collection chamber, in order to allow routing flow into the flow routing mechanism.

[0027] In some embodiments, the urine sample may be collected through a flush valve. In some embodiments, the urine sample may be collected through a cannula. In some embodiments, the urine sample may be collected with a syringe

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which:

[0029] Fig. 1A schematically illustrates a bottom view of a perforated patch attached to a patient, according to some embodiments of the invention;

[0030] Fig. IB schematically illustrates a bottom view of an elastic perforated patch attached to the patient, according to some embodiments of the invention;

[0031] Fig. 1C schematically illustrates a bottom view of a perforated patch embedded in a diaper and attached to the patient, according to some embodiments of the invention;

[0032] Fig. ID schematically illustrates a frontal cross-sectional view of a stability harness attached to the patient, according to some embodiments of the invention; [0033] Fig. 2A schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device with a confinement segment that is configured to allow confinement of urethra orifice from labia majora, according to some embodiments of the present invention;

[0034] Fig. 2B schematically illustrates a frontal cross- sectional view of a non-invasive urine collection device with a confinement segment that is configured to allow confinement of urethra orifice from labia minora, according to some embodiments of the present invention;

[0035] Fig. 2C schematically illustrates a frontal cross- sectional view of a non-invasive urine collection device with a confinement segment having a C- shaped confining edge, according to some embodiments of the present invention;

[0036] Fig. 2D schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device with a confinement segment having a double C-shaped confining edge, according to some embodiments of the present invention;

[0037] Fig. 2E schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device with an inflatable segment, according to some embodiments of the present invention;

[0038] Fig. 3 A schematically illustrates a side cross-sectional view of a non-invasive urine collection device with a confinement routing mechanism, according to some embodiments of the present invention;

[0039] Fig. 3B schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the confinement routing mechanism including collapsing material, according to some embodiments of the present invention;

[0040] Fig. 3C schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism having a top liquid collecting container in a first state, according to some embodiments of the present invention;

[0041] Fig. 3D schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism having a top liquid collecting container in a second state, according to some embodiments of the present invention;

[0042] Fig. 3E schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism having the first liquid collection chamber accommodated within the second liquid collection chamber, according to some embodiments of the present invention;

[0043] Fig. 4A schematically illustrates a bottom view of a peripheral ring of the flow routing mechanism in a first state, according to some embodiments of the present invention; [0044] Fig. 4B schematically illustrates a bottom view of a peripheral ring of the flow routing mechanism in a second state, according to some embodiments of the present invention;

[0045] Fig. 5 A schematically illustrates a first liquid collection chamber coupled to a second liquid collection chamber and an external syringe, according to some embodiments of the present invention;

[0046] Fig. 5B schematically illustrates a first liquid collection chamber coupled to a second liquid collection chamber and a flush valve, according to some embodiments of the present invention;

[0047] Fig. 5C schematically illustrates a first liquid collection chamber coupled to a second liquid collection chamber and a cannula, according to some embodiments of the present invention;

[0048] Fig. 6 schematically illustrates a side cross-sectional view of a non-invasive urine collection device, according to some embodiments of the present invention; and

[0049] Fig. 7 shows a flow chart for a method of collecting urine from a female patient using the non-invasive urine collection device, according to some embodiments of the present invention.

[0050] It will be appreciated that, for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE INVENTION

[0051] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.

[0052] Reference is now made to Figs. 1A-1C, which show various embodiments of a perforated patch attached to a patient. Fig. 1A schematically illustrates a bottom view of a perforated patch 102 attached to a patient 10, according to some embodiments of the invention. In some embodiments, the attachment of perforated patch 102 to patient 10 may be carried out with an adhesive, such as a biocompatible pressure-sensitive adhesive (PSA) or a Silicone adhesive. Perforated patch 102 may be configured to allow flow of urine from external urethral opening 11 through a perforation 104 of patch 102. It should be noted that perforated patch 102 may be removably attached to patient 10 in order to allow simple removal of perforated patch 102 after the urine sample is collected.

[0053] According to some embodiments, perforated patch 102 may cover tissue surrounding external urethral opening 11 , such as the vaginal opening 12, the outer part of the major labia 13 or the anus 15, in order to reduce contamination of the urine to be sampled. In some embodiments, adhesive may not be applied at a predetermined area surrounding perforation 104 such that the adhesive does not engage any genital tissue, and allow easy removal when necessary. It should be appreciated that in contrast to the commercially available pediatric urine collection bag having an adhesive strip, which usually fails to hold the contraption in place, the perforated patch may be removably attached to a large area of the body (e.g. the pelvis) and therefore may provide a stable removable attachment to the patient.

[0054] Fig. IB schematically illustrates a bottom view of an elastic perforated patch 106 attached to patient 10, according to some embodiments of the invention. Elastic perforated patch 106 may comprise an elastic material that may be configured to allow alignment of perforated patch 106 to the shape of the pelvis of patient 10 in order to allow a tight attachment to the body. Similarly to perforated patch 102 (as shown in Fig. 1A), perforated patch 106 may be configured to allow flow of urine from external urethral opening 11 through a perforation 108 of the patch 106. . It should be noted that elastic perforated patch 106 may be removably attached to patient 10 in order to allow simple removal of elastic perforated patch 106 after the urine sample is collected.

[0055] It should be appreciated that such a patch may provide a relatively sterile tract such that a urine sample collected from a patient with a non-invasive method, for instance from female infants, has reduced contamination of the urine from the surrounding tissue. In some embodiments, adhesive may not be applied at a predetermined area 107 surrounding perforation 108 such that the adhesive does not engage any genital tissue, and allow easy removal when necessary.

[0056] Fig. 1C schematically illustrates a bottom view of a perforated patch embedded in a diaper 110 and attached to patient 10, according to some embodiments of the invention. Patient

10 may wear diaper 110 with the perforated patch embedded therein (similarly to wearing regular diapers, e.g. worn on a baby's pelvis by a parent), such that the external urethral opening

11 may be aligned with perforation 114 configured to allow urine flow through perforation 114 in order to collect a sample. It should be noted that such a diaper 110 with the embedded patch may prevent contamination of the collected urine sample by covering surrounding tissue, such as the vaginal opening 12, the outer part of the major labia 13 or the anus 15. Furthermore, similarly to the perforated patch (e.g. as shown in Figs. 1A-1B) adhesive may not be applied at a predetermined area 113 surrounding perforation 114 such that the adhesive does not engage any genital tissue of patient 10, and may allow easy removal of diaper 110 when necessary. In some embodiments, when embedded into diaper 110, there is no need for an adhesive to fasten perforated patch to patient 10. In some alternative embodiments, an adhesive may be applied only to area 113 surrounding perforation 114, such that the rest of diaper 110 has no adhesive.

[0057] It should be appreciated that urine exiting the perforation of the perforated patch (such as perforated patch shown in Figs. 1A-1C), may be collected at a dedicated container (e.g. container 502 as shown in Fig. 5B). For example, manually holding a container adjacent to the perforation to receive urine therein, in order to collect a urine sample with reduced contamination of the urine. In some embodiments, the dedicated container, for collection of a urine sample, may be coupled to the perforated patch.

[0058] Reference is now made to Fig. ID, which schematically illustrates a frontal cross- sectional view of a stability harness 120 attached to patient 10, according to some embodiments of the invention. Stability harness 120 may be configured to removably attach a urine collection device, such as container 502 as shown in Fig. 5B, to the pelvis of patient 10, as further described hereinafter. For example, stability harness 120 may fasten a dedicated liquid collection chamber to be in vicinity of external urethral opening 11. In some embodiments, stability harness 120 may comprise at least one adjustment buckle 122 that may be configured to allow adjustment of the stability harness 120 to tightly fit patient 10, wherein release of the at least one adjustment buckle 122 may release the entire stability harness 120 (e.g. including the dedicated liquid collection chamber).

[0059] Reference is now made to Figs. 2A-2E, which show various embodiments of a noninvasive urine collection device. Fig. 2A schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device 200, according to some embodiments of the invention. Non-invasive urine collection device 200 may be removably attached to patient 10 (e.g. a female patient), such that urine passing from bladder 20 may be collected with at least one dedicated liquid collection chamber 201.

[0060] Non-invasive urine collection device 200 may comprise a confinement segment 202 that is configured to allow confinement of urethra orifice 11 from surrounding tissue. In some embodiments, confinement segment 202 may comprise a flexible confining edge 204 that may correspond in shape and size to the labia 13 of patient 10, for instance corresponds to the labia majora. Confinement segment 202 may be configured to allow separation and isolation of labia 13 from urethra orifice 11, by engaging labia 13, in order to keep the labia 13 separated from urethra orifice 11 and thereby reduce contamination of the urine.

[0061] It should be noted that liquid collection chamber 201 may be in fluid connection to the confinement segment 202 and configured to allow collection of urine therefrom. It should be appreciated that separation of labia 13 from urethra orifice 11 may be carried out in order to minimize contamination of the urine sample (to be collected at a later stage, as further described hereinafter). For instance, contamination from the cutaneous bacteria may be reduced.

[0062] According to some embodiments, confinement segment 202 may be removably attached to patient 10 with a fastening segment 203, coupled to confinement segment 202, and configured to allow fastening of the non- invasive urine collection device 200 to the pelvis of patient 10. In some embodiments, the fastening may be carried out with an adhesive material placed between confinement segment 202 and the pelvis of patient 10. In other embodiments, a perforated patch may fasten confinement segment 202 to the pelvis of patient 10, for instance a perforated patch as shown in Figs. 1A and IB. In some embodiments, such a perforated patch may correspond in shape and size to the labia 13 of patient 10.

[0063] Fig. 2B schematically illustrates a frontal cross- sectional view of a non-invasive urine collection device 210 with a confinement segment 212 that is configured to allow confinement of urethra orifice from labia minora 13, according to some embodiments of the invention. In some embodiments, confinement segment 212 may comprise a confining edge 214 that corresponds in shape and size to the labia minora 13. According to some embodiments, the confining edge of the confinement segment may comprise an elastic material (e.g. an elastomer) and therefore may tightly fit to the pelvis of the patient in order to prevent a gap between the confinement segment and the patient.

[0064] Fig. 2C schematically illustrates a frontal cross- sectional view of a non-invasive urine collection device 220 with a confinement segment 222 having a C-shaped confining edge 224, according to some embodiments of the invention. In some embodiments, confinement segment 222 may comprise a C-shaped confining edge 224 that corresponds in shape and size to the labia 13 (e.g. labia majora). According to some embodiments, non- invasive urine collection device 220 may further comprise a liquid absorbing material 225 coupled to confinement segment 222 and configured to allow absorption of urine flowing outside of the confinement segment 222, i.e. urine flow passing C-shaped confining edge 224 and following outside of the non-invasive urine collection device 220. In some embodiments, C-shaped confining edge 224 comprises an elastic (or flexible) material and may therefore adjust the shape corresponding to the pelvis of patient 10, and also corresponding to changes in volume of liquid absorbing material 225, for instance volume change upon absorption of a large amount of liquid.

[0065] Fig. 2D schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device 230 with a confinement segment 232 having a double C-shaped confining edge 234, according to some embodiments of the invention. Similarly to the C-shaped confining edge 224 as shown in Fig. 2C, the confinement segment 232 may comprise a double C-shaped confining edge 234 that corresponds in shape and size to the labia 13 (e.g. labia majora). Furthermore, non-invasive urine collection device 230 may further comprise a liquid absorbing material 235 coupled to confinement segment 232 and configured to allow absorption of urine flowing outside of the confinement segment 232, i.e. urine flow passing double C-shaped confining edge 234 and flowing outside of the non-invasive urine collection device 230.

[0066] It should be noted that in contrast to the C-shaped confining edge, the double C-shaped confining edge 234 may provide enhanced isolation of urethra orifice from surrounding tissue due to the shape of double C-shaped confining edge 234. Particularly, double C-shaped confining edge 234 may have a smaller diameter and thereby provide a narrower passage for the urine to pass through.

[0067] Fig. 2E schematically illustrates a frontal cross-sectional view of a non-invasive urine collection device 240 with a confinement inflatable segment 244, according to some embodiments of the invention. Inflatable segment 244 may correspond in shape and size to the labia 13 (e.g. labia minora). Furthermore, non- invasive urine collection device 240 may further comprise a liquid absorbing material 245 coupled to inflatable segment 244 and configured to allow absorption of urine flowing outside of the confinement inflatable segment 244, i.e. urine flow passing inflatable segment 244 and flowing outside of the non-invasive urine collection device 240.

[0068] It should be noted that inflatable segment 244 may be configured to allow routing flow into the liquid collection chamber upon inflation Such inflation may be carried out by any user, such as the parent of an infant patient or medical personnel (e.g. a nurse). After the sample is collected, the inflatable segment 244 may be deflated, and the non-invasive urine collection device 240 removed from patient 10. In some embodiments, inflatable segment 244 may be provided in an inflatable state.

[0069] It should be appreciated that in all embodiments described in Figs. 2A-2E, the confinement segment may be removably attached to the patient with a fastening segment, coupled to the confinement segment, and configured to allow fastening of the non-invasive urine collection device to the pelvis of the patient. Furthermore, the fastening may be carried out with an adhesive material placed between the confinement segment and the pelvis of patient.

[0070] Reference is now made to Figs. 3A-3E, which show various embodiments of a flow routing mechanism for the non-invasive urine collection device. Fig. 3A schematically illustrates a side cross-sectional view of a non-invasive urine collection device with a routing mechanism 300, according to some embodiments of the invention. Non-invasive urine collection device may comprise a routing mechanism 300 coupled to at least one liquid collection chamber, wherein flow routing mechanism 300 may be configured to allow routing of urine into the at least one liquid collection chamber. In some embodiments, non-invasive urine collection device comprises a first liquid collection chamber 302 and a second liquid collection chamber 304. Flow routing mechanism 300 may be therefore configured to allow routing of urine into first liquid collection chamber 302, and then into second liquid collection chamber 304. fteliminary (or primary) urine flow may initially fill first liquid collection chamber 302 until a predetermined amount is accumulated such that the remaining (mid-stream) urine may flow into second liquid collection chamber 304.

[0071] It should be noted that the separation of the preliminary urine from the following midstream urine may be done mechanically (e.g. with a one-way valve, with deflection switches, etc.), chemically, electronically or by any other suitable technique. This may allow the preliminary and most contaminated urine to be diverted and isolated (away from first liquid collection chamber 302) in order to allow the subsequently mid-stream urine to be sampled and processed from second liquid collection chamber 304. In some embodiments, additional liquid collection chambers may be utilized in order to remove potentially contaminated urine from the sample to be collected.

[0072] In some embodiments, at least one liquid collection chamber may be configured to allow isolation and separation of the preliminary urine, for instance the first liquid collection chamber. In some embodiments, at least one liquid collection chamber may be configured to allow isolation and separation of the mid-stream urine, for instance the second liquid collection chamber.

[0073] In some embodiments, the flow routing mechanism may comprises a one-way valve configured to allow flow into the at least one liquid collection chamber. In some embodiments, the at least one liquid collection chamber may comprise an over flow flush valve that is configured to flush liquid in case that an amount of accumulated liquid is greater than a predefined threshold. In some embodiments, a one-way valve may route urine flow from urethra orifice and into the at least one liquid collection chamber. [0074] According to some embodiments, first liquid collection chamber 302 may comprise a first valve 301 coupled to second liquid collection chamber 304, such that a fluid connection may be created between first and second liquid collection chambers upon opening of first valve 301. First liquid collection chamber 302 may further comprise an absorbing material 305 coupled to first valve 301, such that liquid (e.g. preliminary urine) entering first liquid collection chamber 302 may therefore be absorbed by absorbing material 305. Such absorption of liquid by absorbing material 305 may change the volume of absorbing material 305 and thereby engage first valve 301 coupled thereto. In some embodiments, first valve 301 may be initially in a closed state such that no liquid may pass from first liquid collection chamber 302 to second liquid collection chamber 304, and only upon engagement by absorbing material 305 first valve 301 may be moved to an open state where fluid may pass between the liquid collection chambers.

[0075] In some embodiments, absorbing material 305 may be chosen to change in volume in a predetermined amount such that first valve 301 may move due to a predetermined amount of liquid absorbed by absorbing material 305. Thus, choosing a predetermined amount of preliminary urine collected in first liquid collection chamber 302, for instance about 2-5 milliliters of liquid, may open first valve 301 (upon sufficient absorption by absorbing material 305) and thereby allow mid-stream urine to pass into second liquid collection chamber 304 to be later collected therefrom.

[0076] In some embodiments, second liquid collection chamber 304 may comprise a second valve that may be initially in a closed state and prevent any liquids from entering second liquid collection chamber 304. Second valve (for instance as shown in Fig. 3B) may be coupled to first valve 301, such that upon opening of first valve 301, second valve may also be opened and allow liquids to pass.

[0077] Fig. 3B schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism 310 having a collapsing material 316, according to some embodiments of the invention. In this embodiment, first valve 313 is not coupled to second valve 311 and first valve 313 comprises a collapsing material 316. Thus, once a sufficient amount of liquid may be collected in first liquid collection chamber 314 and first valve 313 is opened, liquid may pass onto second valve 311 that is initially in a closed state. Upon engagement of the liquid with collapsing material 316 of first valve 313, second valve 311 may move to an open state and thereby allow liquids to enter second liquid collection chamber 312.

[0078] According to some embodiments, the flow routing mechanism may be configured to allow flow into the first liquid collection chamber until a predetermined amount of liquid is collected, and may also be configured to allow flow into the second liquid collection chamber when the predetermined amount of liquid is collected in the first liquid collection chamber. In some embodiments, the flow routing mechanism may comprise a first one-way valve coupled to the first liquid collection chamber, and a second one-way valve coupled to the first liquid collection chamber.

[0079] Fig. 3C schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism 320 having a single valve top liquid collecting container in a first state, according to some embodiments of the invention.

[0080] In some embodiments, second liquid collection chamber 324 may be positioned on top of first liquid collection chamber 322 such that urine may initially pass first valve 321 to the bottom of first liquid collection chamber 322, without entry to second liquid collection chamber 324. First liquid collection chamber 322 may comprise an absorbing material 325, similar to the device described in Figs. 3A-3B, such that urine entering first liquid collection chamber 322 may be absorbed by absorbing material 325. In some embodiments, second liquid collection chamber 324 may comprise a fastening element 323, similar to the device described in Figs. 3A- 3B.

[0081] Fig. 3D schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism 320 having a single valve top liquid collecting container in a second state, according to some embodiments of the invention. Absorption of liquid by absorbing material 325 may change the volume of absorbing material 325 and thereby move first valve 321 (coupled thereto) to be in a closed state. Thus, preliminary urine may be collected at bottom first liquid collection chamber 322, while remaining urine may be collected in second liquid collection chamber 324 since first valve 321 is closed. In some embodiments, at least one valve may comprise a torsion spring (the spring is not shown in the figures).

[0082] Fig. 3E schematically illustrates a side cross-sectional view of a non-invasive urine collection device with the routing mechanism 330 having the first liquid collection chamber 332 accommodated within the second liquid collection chamber 334, according to some embodiments of the invention. In some embodiments, once the predetermined amount of fluid is gathered in first liquid collection chamber 332 first valve 331 may be closed so as to move first liquid collection chamber 332 within second liquid collection chamber 334 in order to allow urine to pass into second liquid collection chamber 334.

[0083] Reference is now made to Figs. 4A-4B, which schematically illustrate a bottom view of a peripheral ring of the flow routing mechanism in first and second states, respectively, according to some embodiments of the invention. Peripheral ring 400 may be embedded into the valve of the flow routing mechanism. Peripheral ring 400 may comprise a collapsing material such that presence of liquid in first liquid collection chamber, for instance as shown in Figs. 3A- 3D, may cause second valve to be opened and thereby allow the liquid to pass to the second liquid collection chamber. In some embodiments, peripheral ring 400 may be provided in a preloaded state, for instance as shown in Fig. 4A, and then change shape due to presence of a liquid.

[0084] In some embodiments, the first liquid collection chamber may be separable from the second liquid collection chamber.

[0085] Reference is now made to Figs. 5A-5C, which show various embodiments for collecting the urine sample from the liquid collection chambers, wherein preliminary urine may be isolated into the first liquid collection chamber and midstream urine may be collected from the second liquid collection chamber. Fig. 5A schematically illustrates a first liquid collection chamber 502 coupled to a second liquid collection chamber 504 and an external syringe 50, according to some embodiments of the invention.

[0086] Second liquid collection chamber 504 may comprise an outlet 501 that is configured to receive external syringe 50, in order to allow removal of the urine sample or a portion thereof (within second liquid collection chamber 504) using the external syringe 50.

[0087] Fig. 5B schematically illustrates a first liquid collection chamber 502 coupled to a second liquid collection chamber 504 and a flush valve 503, according to some embodiments of the invention. The user (e.g. medical personnel) may open flush valve 503 in order to empty (or release a controlled amount of) the content of second liquid collection chamber 504, for instance into an external container, in order to collect the urine sample.

[0088] Fig. 5C schematically illustrates a first liquid collection chamber 502 coupled to a second liquid collection chamber 504 and a cannula 505, according to some embodiments of the invention. Cannula 505 may be permanently coupled to second liquid collection chamber 504 so as to allow a user (e.g. medical personnel) to empty the content of second liquid collection chamber 504 (or a portion thereof), for instance into an external container, in order to collect the urine sample.

[0089] According to some embodiments, second liquid collection chamber may be separable from first liquid collection chamber in order to allow removal of second liquid collection chamber as a container containing the urine sample to be analyzed. Thus, a new second liquid collection chamber may replace the removed second liquid collection chamber for further collection of urine, similarly to replacement tubes in blood analysis. [0090] According to some embodiments, at least one sensor (such as sensor 611 as shown in Fig. 6) may be coupled to the at least one liquid collection chamber, and configured to allow analyzing of urine collected within the at least one liquid collection chamber. Such analyzing may for instance determine presence of Leukocytes, Nitrite, Protein, Blood, and urination volume. In some embodiments, such sensor may be configured to detect bacteria in the urine.

[0091] It should be appreciated that with such a non-invasive urine collection device, it may be possible to reduce invasive procedure in febrile infants and thus reducing pain to patients, as well as reduce physician time and costs.

[0092] Reference is now made to Fig. 6, which schematically illustrates a side cross-sectional view of a non-invasive urine collection device 600, according to some embodiments of the invention. In some embodiments, device 600 for non-invasive urine collection from a female patient, may comprise a confinement segment 601, configured to allow confinement of the urethra orifice 11 of the patient 10 from surrounding tissue, a fastening segment 603 coupled to confinement segment 601, and configured to allow fastening of the device 600 to the pelvis of the patient 10. Device 600 may further comprise at least one liquid collection chamber 602 in fluid connection to confinement segment 601, and configured to allow collection of urine, and a flow routing mechanism 606, configured to allow routing of urine into the at least one liquid collection chamber 602. In some embodiments, non-invasive urine collection device 600 comprises a first liquid collection chamber 602 configured to collect preliminary urine, and a second liquid collection chamber 604 configured to collect midstream urine.

[0093] In some embodiments, non-invasive urine collection device 600 may further comprise a liquid absorbing material 605. In some embodiments, non- invasive urine collection device 600 may further comprise an over flow flush valve 607 that may be configured to flush second liquid collection chamber 604 if collected liquid exceeds a predetermined amount. In some embodiments, non-invasive urine collection device 600 may further comprise an outlet 608 that is configured to provide access to urine collected within second liquid collection chamber 604.

[0094] In some embodiments, non-invasive urine collection device 600 may further comprise cannula 609. In some embodiments, non-invasive urine collection device 600 may further comprise an indicator 610 that is configured to indicate presence of liquid within second liquid collection chamber 604. In some embodiments, non-invasive urine collection device 600 may further comprise at least one sensor 611 coupled to second liquid collection chamber 604 and configured to provide information of detected liquid therein. In some embodiments, sensor 611 may be configured to detect bacteria in the urine. [0095] According to some embodiments, at least one sensor 611 may be one or more chemical pads or reagents which react (e.g. change color) when exposed to, immersed in, or dipped in and then removed from, a urine sample. The one or more sensors or chemical pads may include reagents which react to the presence of one or more of, for example, proteins, glucose, ketones, hemoglobin, bilirubin, urobilinogen, nitrite and leucocytes. According to some embodiments, one or more sensors 611 may be indicative of the pH level of the urine sample or may react to presence of different pathogens.

[0096] Reference is now made to Fig. 7, which shows a flow chart for a method of collecting urine from a female patient using the non-invasive urine collection device, according to some embodiments of the invention.

[0097] Initially, the urethra orifice of the patient may be confined 710 from surrounding tissue, for instance utilizing the confinement segment (e.g. as shown in Figs. 2A-2E). Then, at least one liquid collection chamber may be fastened 720 to the patient, for instance utilizing the fastening segment (e.g. as shown in Figs. 1A-1D). Next, urine may be routed 730 into the at least one liquid collecting chamber, for instance utilizing the routing mechanism (e.g. as shown in Figs. 3A-3D). The preliminary urine may be separated 740 from the midstream urine, for instance utilizing the routing mechanism (e.g. as shown in Figs. 4A-4B). And finally, the collected urine sample may be removed 750, for instance as shown in Figs. 5A-5C.

[0098] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0099] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein.