System and method for medical diagnostics

A system and a method for a medical diagnostic device are described herein. The medical diagnostic device can include an outer sleeve having a hollow interior and open distal and proximal ends, the outer sleeve being defined by a substantially tubular configuration including a proximal section having a substantially conical shape. A core is configured to be inserted axially within the outer sleeve. The core includes an axial inner cavity. The core is further defined by a proximal section having a conical shape substantially conforming to the proximal section of the outer sleeve. The core retains a diagnostic assembly, that can include at least one of a sample collecting assembly and an imaging assembly, that can be integrally or interchangeably attached and wherein the device can be utilized for self-patient or single patient use.

TECHNICAL FIELD

This application generally relates to the field of medical devices and more specifically to a medical diagnostic device that permits various functionalities, such as imaging and sample collection that can be done interchangeably or in tandem. In at least one version, the medical diagnostic device can be used for body cavity examinations, such as examinations of the cervix.

BACKGROUND

There are known medical devices used for examining various anatomical cavities of patients. For example, vaginal specula are used in the diagnostic medical field to examine the cervix of a female patient. Over time, a number of various specula designs have been developed. Typically, a Graves speculum is defined by an upper blade and a lower blade, the latter including a pistol-grip like handle portion. The speculum is inserted in the vagina of a female patient and the upper and lower blades are articulated to facilitate examination of the cervix of the female patient.

After insertion of the vaginal specula, the medical professional can visually examine the patient's cervix, either by looking through the passage created between the blades of the vaginal speculum or by inserting an imaging device between the blades of the vaginal speculum. However, inserting the imaging device can disturb the inserted vaginal speculum and can be uncomfortable for the patient. Furthermore, the imaging device must be sterilized between uses to prevent any contamination from being transferred between patients. In addition to visually examining the patient's cervix, the medical professional can take a vaginal sample by inserting a sample collecting device within the passage created between the blades of the vaginal speculum and gathering the sample. The sample collecting device, however, may contact additional surfaces during the process, thus potentially contaminating the sample.

Vaginal specula require a clinician, or other caregiver, typically a medical professional, to insert the speculum and perform the examination. However, many patients experience embarrassment and discomfort at the idea of experiencing such an intimate and potentially uncomfortable examination. Because of this discomfort, many women elect not to have these examinations performed. As a result, serious medical conditions, such as cervical cancer, can remain undiagnosed or be diagnosed at a stage that is too late to effectively treat.

BRIEF DESCRIPTION

Various embodiments of a medical diagnostic device are described herein. Advantageously and according to at least one version, the medical diagnostic device can enable a patient to perform a self-examination and take patient samples without requiring the presence of a clinician. These samples and/or gathered image data can be sent to a medical professional for analysis and a follow-up office visit can be scheduled if the medical professional deems it appropriate.

In addition, embodiments of the medical diagnostic device described herein integrate sample and/or image collecting functions directly within the device. This integration simplifies operation of the device. Additionally, integration protects the sample collector from contamination during insertion and retraction of the medical diagnostic device.

According to a first aspect, a medical sampling device is described. The medical sampling device includes an outer sleeve having a hollow interior and open distal and proximal ends. The outer sleeve is defined by a substantially tubular configuration including a proximal section having a substantially conical shape. The medical sampling device also includes a core that is configured to be inserted axially within the hollow interior of the outer sleeve. The core can have a substantially tubular shape, including an axial inner cavity, and further including a proximal section having a conical shape substantially conforming to that of the proximal section of the outer sleeve. The medical sampling device can further include a sample collecting assembly. The sample collecting assembly includes a hollow rotatable shaft extending through the axial inner cavity of the core, the shaft having an engagement member positioned at a proximal end of the shaft and retained within the conical section of the core. The sample collecting assembly additionally includes an ejector pin extending entirely through the hollow rotatable shaft and a sample collector coupled to the ejector pin.

According to at least one version, the outer sleeve can further include a distal expansion section that is configured to transition between a closed position and an open deployed position. The distal expansion section can include a plurality of petals or fingers, the plurality of fingers being movable between the closed position and the open deployed position. The medical sampling device can further include a flexible sheath extending over the distal expansion section of the outer sleeve. The flexible sheath can be formed of an elastomeric material. According to at least one version, the proximal conical section of the outer sleeve can be compressible to enable the core and the sample collecting assembly to be retracted from a deployed position to an insertion position within the outer sleeve. The proximal conical section of the outer sleeve can include two or more locator pads positioned opposite each other to facilitate compression. The ejector pin is selectively engageable to eject the sample collector from the vaginal sampling device. The engagement member can be, for example, a rotatable knob that includes a recessed center portion sized to retain the ejector pin in a safety position in order to prevent unintentional ejection of the sample collector while in a deployed position within the patient. The sample collector includes a coupling portion configured to releasably couple the sample collector to a distal end of the ejector pin. For example, the coupling portion can include one of a keyway and a key and the distal end of the core or a rotatable shaft retaining the ejector pin can include the other of the keyway and the key to facilitate rotation of the sample collector. The sample collector can be a brush having a plurality of bristles that is supported for rotation to obtain a patient sample. The medical sampling device can further include an imaging device extending through the axial cavity of the core. A thin elastic sheath can be coupled to the outer sleeve. At least one stop surface can be positioned on an inner surface of the outer sleeve to prevent unintentional ejection of the core from the outer sleeve.

According to another aspect, a method for obtaining a sample from a patient using a medical diagnostic device is described herein. The diagnostic device includes an outer sleeve having a hollow interior with open distal and proximal ends, a core, and a sample collecting assembly. The sample collecting assembly includes a shaft having a sample collector at a distal end and an engagement member on an opposing proximal end. In this embodiment, the method includes inserting the sample collecting assembly axially through an inner cavity of a core, the core having a substantially tubular shape including a proximal section having a conical shape substantially conforming to a proximal section of the outer sleeve upon insertion. The method additionally includes inserting the core and sample collecting assembly axially through the outer sleeve and positioning the distal end of the vaginal diagnostic device within a vagina of the female patient. The method further includes repositioning the core and sample collecting assembly from an insertion position to a deployed position to extend the sample collector beyond the distal end of the outer sleeve and manipulating the sample collector to collect a patient sample, such as from the vagina or other anatomical cavity of a patient.

In an embodiment, the proximal section of the outer sleeve is compressible to enable the core and sample collecting assembly to be retracted from the deployed position to a nominal insertion position within the outer sleeve. The method can further include compressing the outer sleeve to retract the core and sample collecting assembly from the deployed position to the insertion position and withdrawing the medical diagnostic device from the patient. The method can further include engaging an ejector pin of the sample collecting assembly to eject the sample collector from the shaft. The sample collector can include a coupling portion configured to releasably couple the sample collector to a distal end of the shaft. According to at least one version, the coupling portion can include at least one keyway and at least one key and the distal end of the core or the shaft supporting the ejector pin can include the other of the keyway and the key to facilitate manipulation of the sample collector. Manipulation of the sample collector can include rotation of the sample collector.

The outer sleeve can further include a distal expansion section that is configured to transition between a closed position and an open deployed position. Repositioning the core and sample collection assembly can further include transitioning the distal expansion section from the closed position to the open deployed position to facilitate extending the sample collector and collecting the patient sample. The method can further include inserting an imaging device axially through the hollow rotatable shaft adjacent to the sample collector. The method can additionally include coupling a thin elastic sheath to the outer sleeve to provide stabilization, for example, in the instance of female patients who have had multiple children. A distal end of the outer sleeve can be inserted axially through a flexible sheath. The medical diagnostic device can be configured to be deployed within a body cavity (e.g., the vagina) of a patient and to be acted upon to collect a sample.

According to yet another aspect, a medical diagnostic device is described. The medical diagnostic device includes an outer sleeve having a hollow interior and open distal and proximal ends. The outer sleeve is defined by a substantially tubular configuration including a proximal section having a conical shape. The medical diagnostic device also includes a core configured to be inserted axially within the outer sleeve. The core has a substantially tubular shape including an axial cavity and a proximal section having a conical shape substantially conforming to the proximal section of the outer sleeve. The core further includes a diagnostic assembly retained therein.

In at least one embodiment, the diagnostic assembly can be a sample collecting assembly. The sample collecting assembly can include a hollow rotatable shaft extending through the axial cavity of the core, the shaft having an engagement member positioned at a proximal end of the shaft and retained within the conical section of the core, an ejector pin extending entirely through the hollow rotatable shaft, and a sample collector coupled to the ejector pin. In another embodiment, the diagnostic assembly can include an imaging device, such as a borescope, positioned in a sampling end of the axial cavity of the core. A cable can extend through the axial cavity of the core to couple the imaging device to an external computing device. In yet another embodiment, the diagnostic assembly includes a hollow rotatable shaft extending through the axial cavity of the core, the shaft having an engagement member positioned at a proximal end of the shaft and retained within the conical section of the core, an ejector pin extending entirely through the hollow rotatable shaft, a sample collector coupled to the ejector pin, and an imaging device positioned adjacent to the sample collector. The medical diagnostic device can further include a distal expansion section of the outer sleeve configured to transition between an unopened insertion position and an open deployed position. A flexible sheath can extend over the expansion section of the outer sleeve.

By having an imager in the core in addition to a sampling device, a user can more efficiently direct the sampling device to the intended target of interest. Photographs or streaming video can be taken of the intended target of interest to document abnormalities for contemporaneous or later examination by a clinician. Additionally, the images or video can be stored for future reference or training purposes. This imaging will also allow the patient to see images of the target of interest directly and in which the photographs or video can be sent to the clinician or elsewhere for archiving.

These and other features and advantages will become apparent to those skilled in the art when taken with reference to the following more detailed description of the various embodiments of the invention in conjunction with the accompanying drawings that are first briefly described.

DETAILED DESCRIPTION

The following Detailed Description should be read with reference to the accompanying drawings, in which like elements in different drawings are identically numbered for the sake of clarity. The drawings, which are not necessarily to scale, are intended to depict salient features of the design in selected embodiments and are not intended to limit the intended scope of the invention, except where so expressly indicated. The Detailed Description illustrates by way of example, not by way of limitation, the principles of the invention. This Description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

In addition, various terms are used throughout in order to provide a suitable frame of reference with regard to the accompanying drawings such as “lower”, “upper”, “top”, “within”, “lateral”, “upon”, “front”, “back”, and the like. These terms are also not intended to overly limit the scope of the herein described invention. As used herein, the terms “patient” or “user” refer to any human or animal subject such as a clinician or other caregiver, and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment. As used herein, the term “distal end” refers to an end of the herein described diagnostic device closest to the patient during use, and the term “proximal end” refers to an end of the herein described medical diagnostic device furthest from the patient during use.

The terms “about” and “substantially” are used in connection with a numerical value throughout the description and claims denotes an interval of accuracy, familiar and acceptable to a person skilled in the art. The interval governing this term is preferably ±30%. Unless specified, the terms described above are not intended to narrow the scope of the invention as described herein and according to the claims.

Certain embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the systems and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting and that the scope of the present disclosure is defined solely by the claims. For purposes of the following description, it should further be noted that the features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the intended scope of the present disclosure. For purposes of the following embodiments, the devices that are described herein are intended for use in conducting vaginal examinations. It will be readily understood, however, that similar devices having features as described herein can also be used in connection with the examination of other anatomical cavities of a patient.

With reference to the drawings and according toFIGS. 1-6B, there is depicted a medical diagnostic device2A in accordance with a first embodiment. In this particular embodiment, the medical diagnostic device2A is a vaginal sampling device that is defined by respective open proximal and distal ends1,3and in which the distal end3of the device2A is also synonymously referred to herein as a “sampling end”. The medical diagnostic device2A includes an outer sleeve4that is defined by a substantially tubular configuration and a hollow interior9. According to this specific embodiment, the outer sleeve4is further defined by a proximal section6having a substantially conical shape and an opposing distal section8. In accordance with this embodiment, the substantially conical proximal section6of the hollow outer sleeve4(or the entire outer sleeve) is made from a lightweight plastic or other suitable material that enables the substantially conical proximal section6to be flexed (i.e., compressed) inwardly. To facilitate this compression, the substantially conical proximal section6of the outer sleeve4can include at least two locator pads20, each positioned diametrically opposite each other to identify where to apply pressure to the conical proximal section6.

The distal section8of the outer sleeve4includes an expansion section10that is configured to expand and retract. In an example, the expansion section10may be formed of a plurality of fingers11that are configured to move toward and away from each other as the expansion section10expands and retracts. More specifically and according to this particular embodiment, the fingers11are circumferentially disposed and defined by a series of axial cuts13,FIG. 4B, that are formed in the outer sleeve4and extending from the distal end of the sleeve4toward the proximal end thereof.

In accordance with this specific embodiment, an elastically deformable sheath14overlays the distal section8of the outer sleeve4, including the expansion section10of the device2A, such that the elastically deformable sheath14substantially covers the tubular section of the outer sleeve4. In an example, the elastically deformable sheath14can be formed of an elastomeric material or a rubber-like material in which the shape of the sheath14is created by injection or blow molding or by another suitable manufacturing process. When attached in overlaying fashion to the outer sleeve4, the sheath14elastically deforms or stretches as the expansion section10expands and similarly contracts as the expansion section10contracts. Functionally, the elastically deformable sheath14acts to prevent the expansion section10from pinching the patient when in use.

In addition, a core16is sized and configured to be retained axially within the hollow interior9of the outer sleeve4. According to this specific embodiment, the core16is defined by a substantially tubular shape having a distal section27, as well as an opposing proximal section28, wherein the latter proximal section28is further defined by a substantially conical shape that closely corresponds with that of the substantially conical proximal section6of the outer sleeve4. At least one stop surface38can be positioned along the inner surface of the outer sleeve4. According to this embodiment, the at least one stop surface38interacts with at least one stop groove40, formed on an exterior surface of the core16to prevent the core16from falling out of the outer sleeve4when the vaginal diagnostic device2A is inserted in the female patient.

Still referring toFIGS. 1-6B, the core16is defined by an axial cavity17extending through the length of the core16along an axis A,FIG. 4. The axial cavity17is configured to retain a diagnostic assembly therein. According to this specific embodiment, the diagnostic assembly is a sample collecting assembly19that is defined by a sample collector12, an ejector pin22, and a hollow rotatable shaft24. In the illustrated embodiment, the hollow rotatable shaft24has an engagement member26positioned at a proximal end18of the rotatable shaft24and the core16. The engagement member26is retained within the conical proximal section28of the core16when the sample collecting assembly19is retained in the core16. The ejector pin22is inserted axially within and extends entirely through the hollow rotatable shaft24. The engagement member26facilitates manipulation, such as rotation about axis A, of the hollow rotatable shaft24, the ejector pin22, and the sample collector12.

The sample collector12is coupled to the ejector pin22and the hollow rotatable shaft24at the distal end3of the device2A. The sample collector12can be any suitable device for collecting a vaginal sample, such as a brush having a plurality of disposed bristles31. The sample collector12can have a coupling portion32that is configured to releasably couple the sample collector12relative to a distal end of the rotatable shaft24. As illustrated byFIG. 6B, the coupling portion32is one of a keyway and a corresponding key formed at the proximal end of the sample collector12and the distal end of the rotatable shaft24including the other of the keyway and the corresponding key. For example and as shown according to this embodiment, a set of female keyways34are formed at the distal end of the hollow rotatable shaft24that receives a corresponding set of keys36formed on the proximal end (coupling portion32) of the sample collector12. Ejection is permitted when the ejector pin22is axially advanced toward the distal end of the device2A, which corresponding advances the sampling collector12and more specifically the keys36from the keyways34. Other suitable releasable connections can be utilized, provided that these components remain coupled until ejection or removal of the sampling collector12is desired. This coupling portion32facilitates rotation of the sample collector12using the hollow rotatable shaft24during collection of a patient sample.

According to this embodiment, the ejector pin22is selectively engageable to eject the sample collector12from the medical diagnostic device2A. As illustrated herein, the engagement member26includes a recessed center portion30that is sized to retain the ejector pin22in a “safety” position in order to prevent unintentional ejection of the sample collector12via the ejector pin22. For example, this safety position prevents ejection of the sample collector12from the ejector pin22while the medical diagnostic device2A is inserted in a female patient. As illustrated inFIG. 8and when the ejector pin22is engaged, the sample collector12is released from the sample collecting assembly19. In an example, the sample collector12can be released from the assembly for depositing into a sample container44. This sample container44can be then be transported to a medical practitioner or a laboratory for testing.

Another embodiment of a medical diagnostic device2B is illustrated inFIG. 9. As in the prior embodiment, the vaginal diagnostic device2B according to this version also includes an outer sleeve4having a substantially tubular configuration including a substantially conical proximal section6as well as an opposing distal section. In addition, a core16is also similarly retained axially within the hollow interior9of the outer sleeve4in which the core16is defined by respective distal and proximal sections27,28and further includes an inner axial cavity17extending axially through the distal and proximal sections27,28. In this embodiment, the core16has an engagement member26coupled to the proximal section28of the core16. In this version, the proximal section28of the core16is not conical in configuration though the latter section28is still sized and configured to engage the conical proximal section6of the outer sleeve4. As discussed above, the core16is configured to retain a diagnostic assembly within the axial cavity17. According to this embodiment, the diagnostic assembly is an imaging device56that is inserted axially within the inner axial cavity17of the core16and positioned within the distal section27. The imaging device56may, for example, be a CCD, CMOS, ultrasound, infrared, RF, or other form of electronic device. According to this version, the imaging device56is a borescope having an electronic imager having a cover glass to protect the interior of the imager from contaminants and an imaging lens disposed within a compact housing that is tethered to a power source (not shown) such as an AC power supply or, alternatively, to batteries or other compact and portable power supply, such as a super capacitor (not shown). The imaging device56can include at least one LED or other illumination source disposed in relation to the electronic imager to provide sufficient illumination of the medical target of interest (e.g., the vagina). The imaging device56can be configured to gather still images, video, or both still images and video, which can be displayed to the caregiver or the patient on a computer, tablet, pad or mobile device.

According to this embodiment, the outer sleeve4, and more specifically the distal section of the vaginal diagnostic device2B, has an expansion section10. When the core16advances within the outer sleeve4, the expansion section10is configured to expand from a closed position upon insertion to an open or deployed position and wherein the expansion section10can include a series of circumferentially spaced fingers11,FIG. 7, that are expanded outwardly radially when in the deployed position. The axial advancement of the core16relative to the target of interest positions the imaging device56closer to the opening42of the distal end of the outer sleeve4, thereby improving the visual coverage of the imaging device56and resulting in a “zoom” effect.

In accordance with an embodiment, the imaging device56can be coupled to a computing device58to which gathered image data can be transmitted for analysis. The computing device58can be any suitable device, such as a computer, a tablet, or a smartphone, among others. While the imaging device56is illustrated here as being coupled to the computing device58via a wired connection52, it is to be understood that the imaging device56may alternatively be wirelessly coupled to the computing device58. In an example, the image data can be transmitted to a patient's computing device58and the patient can transmit the data from the computing device58to a medical professional for analysis, such as through a medical data network. In another example, the image data can be transmitted directly from the imaging device56to a medical professional's computing device58.

With reference toFIGS. 10A and 10B, there is depicted another embodiment of a medical diagnostic device2C. Similarly to the prior embodiments discussed herein, the vaginal diagnostic device2C includes an outer sleeve4having a tubular configuration with a proximal conical portion6and in which the outer sleeve4is further defined by a hollow interior9. The outer sleeve4also has a distal expansion section10that can be overlaid by an elastically deformable sheath14. A core16is disposed axially within the hollow interior9of the outer sleeve4and includes an engagement member26coupled to a proximal section28of the core16, the latter section28being fitted within the substantially conical proximal portion6of the outer sleeve4. In this specific embodiment, the diagnostic assembly includes a vaginal sampling assembly19as well as an imaging device56. The vaginal sampling assembly19includes an ejector pin22disposed axially through the interior of the core16and a sample collector12that is releasably coupled to the ejector pin22. The imaging device56is also disposed axially through the interior of the core16and is positioned adjacent to the sample collector12in substantially parallel relation. As in the preceding, the imaging device56can be a borescope that is coupled to a computing device58by means of a wired or wireless connection to transmit image data that is gathered by the imaging device56to the computing device58for display and archiving. According to this specific embodiment, the sampling and imaging components are disposed in parallel relation to one another and off center within the apparatus (core16).

During use, the medical diagnostic device2C is inserted within an anatomical body cavity (e.g., the vagina) of the patient and the core16is advanced toward the distal end within the outer sleeve4. Upon axial advancement of the core16, the expansion section10is configured to have its fingers11,FIG. 7, expand outwardly radially with the imaging device56and the sample collector12advancing toward the distal end of the diagnostic device2C to collect image data and vaginal samples, respectively.

As discussed above, each of the previously described medical diagnostic devices2A,2B,2C commonly includes a distal expansion section10that is configured to transition between a closed insertion position and an open or deployed position. As illustrated inFIGS. 5-6and when the medical diagnostic device2A,2B,2C is inserted into the anatomical cavity of the patient, the expansion section10is initially in a closed, non-expanded position, the sample collector12is positioned within the outer sleeve4, and the core16is not advanced within the outer sleeve4so that the substantially conical proximal section28of the core16is not received in the hollow conical section6of the outer sleeve4. As illustrated inFIG. 7and when the medical diagnostic device2A,2B,2C is in the open, deployed position, the expansion section10expands, the sample collector12extends beyond the outer sleeve4through an opening42in the outer sleeve4, and the core16advances axially within the outer sleeve4toward the distal end so that the conical section6of the outer sleeve4receives the conical section28of the core16. When the conical section6of the outer sleeve4is compressed, using the at least two locator pads20,FIG. 1, or otherwise, the medical diagnostic device2A,2B,2C transitions back from the deployed position to the insertion position. During this transition, the at least one stop surface38of the outer sleeve4interacts with the at least one stop groove40on the outer surface of the core16to prevent the core16from falling out of the outer sleeve4when the medical diagnostic device2A,2B,2C is inserted in the female patient. This stop surface38and stop groove40are particularly efficacious for preventing the core16from falling out of the outer sleeve4when the medical diagnostic device2A,2B,2C transitions from the deployed position to the insertion position.

As discussed, the herein depicted diagnostic device2A,2B,2C is capable of assuming various positions when used in conjunction with a patient. More specifically and according to this depicted embodiment and when the medical diagnostic device2A,2B,2C is in the open or “deployed” position, as illustrated inFIG. 1, the expansion section10is caused to expand, allowing a diagnostic device, such as a sample collector12or imaging device56, to extend from the interior of the outer sleeve4. As will be further discussed below, the core16is configured to axially advance within the outer sleeve4. Advancement of the core16within the outer sleeve4extends the sample collector12beyond the outer sleeve4as the expansion section10outwardly and radially expands from the insertion position to the deployed position.

When the medical diagnostic device2A,2B,2C is in the closed insertion position, as illustrated inFIGS. 2-3, the expansion section10is not yet expanded, facilitating insertion of the medical diagnostic device2into the body cavity, such as the vagina of a female patient. In this closed insertion position, the diagnostic device, (e.g., the sample collector12or imaging device56) remains retracted within the hollow interior9of the outer sleeve4. This retracted position of the sample collector12facilitates insertion of the medical diagnostic device2and protects the sample collector12from inadvertently touching vaginal tissue until the diagnostic device2A,2B,2C is properly positioned.

As discussed above, the substantially conical proximal section6of the outer sleeve4can be flexed or compressed inwardly. In particular, during use, a inwardly radially directed force is applied simultaneously to the exterior of the proximal section6and preferably to the at least two locator pads20,FIG. 1, causing inward flexion of the conical proximal section6towards the axis A. This inward flexion causes corresponding portions of an internal wall surface of the proximal section6to be placed into intimate contact with an outer or external surface of the substantially conical proximal section28of the core16. This engagement triggers axial retraction of the core16and the sample collector12along the axis A (FIG. 5) from the open deployed position in which the core16is advanced within the outer sleeve4and the sample collector12extends beyond the outer sleeve4to the closed insertion position in which the core16and the sample collector12are retracted within the hollow interior9of the outer sleeve4.

As discussed above, in an embodiment, the expansion section10may be formed of a plurality of fingers11which are positioned adjacent to each other when the medical diagnostic device2A,2B,2C is in the closed insertion position. When the medical diagnostic device2A,2B,2C is in the deployed position, the spacing between the fingers11increases in order to expand the expansion section10. For example, as the core16advances axially along the outer sleeve4, the core16pushes against the fingers11, causing the fingers11to move radially outwardly, away from each other. In this example, the elastically deformable sheath14prevents the flesh of the patient from becoming caught and pinched between the moving fingers11. An inflatable cuff (not illustrated) can additionally be pneumatically and mechanically coupled to the hollow outer sleeve4to provide additional support and stabilization for the vaginal tissue of the patient. In one version, the inflatable cuff could be used in lieu of the fingers.

A method of employing a medical diagnostic device2, in accordance with an embodiment, is herein sequentially illustrated inFIGS. 11A-11H. The medical diagnostic device2, which in this specific instance is most closely similar to the device2A, can be employed to examine the vagina of a female patient80, although any of the herein described devices or equivalents could be similarly employed. In an embodiment, the medical diagnostic device2described herein can be used by a patient to perform an self-diagnosis without the need for a medical professional to be physically present during the examination. In an example, the examination can be performed by the female patient80in the patient's home or in private in a medical office. In another embodiment, the medical diagnostic device2can be employed by a medical professional in performing an examination of the female patient80.

Initially and as illustrated inFIG. 11Aand during an examination, the distal end of the medical diagnostic device2is inserted in the vagina82of the female patient80and advanced in the direction depicted by arrow83, within the vagina82toward the cervix84. When the distal end of the vaginal diagnostic device is positioned near the cervix84and before the uterus86, as illustrated inFIG. 11B, there is no further advancement of the vaginal diagnostic device2.

As illustrated inFIG. 11C, when the vaginal diagnostic device2is suitably positioned within the female patient80, the user applies a force to the engagement member26using the hand88of the user. Because the engagement member26is seated within the conical section28of the core16, the force is transmitted to the core16, causing the core16to advance axially within the outer sleeve4until the conical section28of the core16is received in the conical section6of the outer sleeve4. Advancement of the core16triggers expansion of the expansion section10, thus causing the medical diagnostic device2to transition from the closed insertion position to the open deployed position. As illustrated inFIG. 11D, when the medical diagnostic device2is in the open deployed position, the diagnostic assembly extends. For purposes of this example, the diagnostic assembly can include a sample collecting assembly19, an imaging device56, or a combination of the sample collecting assembly19and the imaging device56. In the open deployed position, the user of the diagnostic device2manipulates (e.g., rotates) the engagement member26, which due to the connection between the engagement member26and the diagnostic assembly, correspondingly causes the entire diagnostic assembly to rotate. In this specifically illustrated embodiment, the diagnostic assembly is a sample collecting assembly19that includes a sample collector12. In this embodiment, in the deployed position, the sample collector12extends and rotation of the engagement member36causes the sample collector12to rotate and engage the cervix in order to gather a sample. Similarly, when the diagnostic assembly includes an imaging device56, the imaging device56extends and is also permitted to rotate in order to gather image data.

Following collection of the sample (and/or image data), the user compresses the conical section6of the medical diagnostic device2with the user's hand88. For example, the female80applies a force to the spaced locator pads20, causing inward depression of the conical section6of the outer sleeve4. This compression of the proximal conical section7engages and retracts the core16via engagement with the proximal conical portion28from the open deployed position to the closed insertion position. During this axial movement, the stop surface38of the outer sleeve4positively engages the stop groove40of the core16to prevent the core16from further movement and also from ejecting entirely from the outer sleeve4. Following retraction of the core16, the user80moves the medical diagnostic device2downward, in the direction of arrow92, away from the cervix84as illustrated inFIG. 11F. As illustrated inFIG. 11G, the medical diagnostic device2is removed from the vagina82. As illustrated inFIG. 11H, when the diagnostic assembly is a sample collecting assembly, following removal of the medical diagnostic device2, the patient80applies a force to the proximal end of the ejector pin22. This force causes the ejector pin22to release the sample collector12from the ejector pin22by advancing the sample collector12beyond the distal end of the keyed rotatable hollow shaft24. In an example, the sample collector12can be ejected into a sample container44. This sample container44can be sent to a medical professional for analysis. If the diagnostic assembly includes an imaging device56, the image data gathered by the imaging device56can be sent to a medical professional for analysis.

While this method is illustrated herein as employing the vaginal diagnostic device2A including a sample collector12, it is to be understood that the method can employ any of the previously described embodiments of the medical diagnostic device2A,2B,2C previously described herein. Further, while the method is described as collecting a vaginal sample, it is to be understood that the herein described medical diagnostic device can collect a sample, image data, or a combination of a sample and image data.

As illustrated inFIG. 12, a method94of utilizing a medical diagnostic device, such as the diagnostic device2A,2B,2C described above, includes, at block96, inserting a diagnostic assembly axially through a core. In an example, the diagnostic assembly includes a sample collector coupled to an ejector pin that is inserted axially through a rotatable shaft. In another example, the diagnostic assembly is an imaging device. In yet another example, the diagnostic assembly is both a sample collector and an imaging device.

At block98, the core and diagnostic assembly are inserted axially through the outer sleeve of the medical diagnostic device. At block100, the distal end of the diagnostic device is positioned within the vagina or other body cavity of the patient. The medical diagnostic device is then advanced through the vagina to the cervix. At block102, the core is repositioned from an insertion position to a deployed position. At block104, the diagnostic assembly is manipulated to collect a patient sample and/or image data.

With reference toFIGS. 13A and 13B, there is depicted a medical diagnostic device200which is made in accordance with another embodiment. The diagnostic device200includes an outer sleeve204that is defined by a distal portion208, a proximal portion212as well as a hollow interior214. The majority of the outer sleeve204, including the distal portion208, is defined by a substantially tubular configuration having a substantially constant diameter that transitions to the proximal portion212, the latter being defined by a tapering or substantially conical shape. According to this embodiment, at least one stop surface216is provided along an inner surface of the outer sleeve204at the transition between the tubular and conical sections208,212of the outer sleeve204. More specifically, the stop surface216can be an axial projection.

A core220is positioned within the hollow interior214of the outer sleeve204. The core220according to this embodiment is defined by an elongate tubular member224that includes an exterior surface228, as well as respective distal and proximal portions232,236. The core220further includes a hollow tapering or conical portion240extending from the proximal portion236of the elongate tubular member224and in which the proximal end of the hollow proximal conical portion240includes an engagement member246, which according to this embodiment is in the form of a knob. A pair of stop grooves244,248are provided in the exterior surface228of the core220in spaced relation. In an initial position, the stop surface216is engaged with a distal stop groove244, also as shown inFIG. 13A, which prevents the core220from being retracted outwardly beyond a predetermined axial position.

Still referring toFIG. 13Aand extending from an axial opening221formed in the distal end of the core220is a sampling device260that is formed as part of a diagnostic assembly, the remainder of which is initially provided and retained within the core220. The diagnostic assembly, according to this embodiment, includes an ejector rod256having a proximal end261that extends initially from the proximal end225of the elongate tubular member224and within a recess241that is formed in the hollow proximal conical portion240. The ejector rod256is axially movable within the core220, the distal end of the core220further supporting a sample collecting device260. With reference toFIGS. 13A and 14A, the distal end of the core220includes at least one keyway268that is configured to engage a corresponding number of keys270radially extending from a proximal or coupling portion271of the sample collecting device260. According to this embodiment, the sample collecting device260is a brush having a series of circumferentially disposed bristles276at its distal end. According to this embodiment, the sampling device260is further defined by a shaft280disposed between the bristles276and the coupling portion271that is angled relative to a common primary axis defined by the core220and the outer sleeve204, when assembled, and as shown inFIG. 13A. Alternatively, the shaft could form a curved section relative to the primary axis of the assembly.

In a second or deployed position, shown inFIG. 13Band after the diagnostic device200has been implanted into the body cavity (e.g., vagina) of a patient (not shown), the core220is advanced axially toward the distal end of the outer sleeve204, which advances the sample collecting device260through a formed distal opening of the outer sleeve204. Axial movement proceeds until the stop surface216engages the second spaced stop groove248, the latter groove248being disposed adjacent the transition of the conical portion240of the core220. In this position, the substantially conical sections212,240of the outer sleeve204and core220are nested. The angled shaft280of the sample collecting device260better insures the ability of the sample collecting device260and more specifically the disposed bristles271to engage the surface of the cervix (not shown) in order to obtain a suitable sample through rotation of the core220as accessed using the engagement member246. As shown inFIG. 14A, the proximal end of the sample collecting device260includes a coupling portion having a pair of radially disposed keys286that are aligned with corresponding keyways268at the end of the ejector rod256. In this position, the keys270and keyways268are still engaged within the distal end of the core220, thereby retaining the sample collecting device260in use.

To eject the sample collecting device260, the proximal end of the ejector rod256is axially advanced by the user (not shown), which advances the coupling portion of the sample collecting device260from the core220and the outer cavity204. Prior to ejection, the formed recess241of the hollow conical portion240protects inadvertent contact with the projecting end261of the ejector rod256when the diagnostic device200is still in use and prevents premature ejection of the sample collecting device260.

With reference toFIGS. 14(a) and 14(b), the shoulder above the key is sized according to this specific embodiment so as not to allow passage through the distal end of the outer sleeve204. The foregoing feature is provided chiefly to insure patient safety.

An alternative sample collecting device290is shown inFIG. 14B. According to this version, the sample collecting device290is a brush that is defined with angled bristles294extending from the distal end of the sample collecting device290when in the deployed position. As in the preceding version, this device also includes a coupling portion at a proximal end having a set of keys (or keyways) configured for engaging corresponding keyways formed at the distal end of the core220.

Reference is herein made toFIGS. 15-18, depicting yet another embodiment of a medical (vaginal) diagnostic device300. The diagnostic device300is defined by an outer sleeve304having a distal portion308and a proximal portion312, as well as a hollow interior314. The majority of the outer sleeve304, including the distal portion308is defined by a substantially tubular configuration having a constant diameter that transitions to the proximal portion312, the latter being defined by an outwardly tapering or substantially conical shape. At least one stop surface316, in this instance, at least one axial projection is provided along an inner surface of the outer sleeve304at the transition between the tubular and conical sections308,312of the outer sleeve304.

A core320(also herein referred to synonymously as an obturator) is positioned within the hollow interior314of the outer sleeve304.304. The core320according to this embodiment is defined by an elongate tubular member324that includes an exterior surface328, as well as respective distal and proximal portions332,336. The core320further includes a hollow tapering or conical portion340that outwardly and radially extends from the proximal portion336of the elongate tubular member324and in which a proximal end of the hollow proximal conical portion340includes an engagement member346, which according to this embodiment is a formed knob and in which the hollow proximal conical portion340is further defined by a formed recess341. A pair of stop grooves344,348are provided in the exterior surface328of the core320in spaced relation. In an initial position, the stop surface316is engaged with a distal stop groove344, as shown inFIG. 15which prevents the core320from being retracted beyond a predetermined axial position, as shown.

Still referring toFIG. 15and extending from an axial opening321formed in the distal end of the core320is a sampling device360that is formed as part of a diagnostic assembly, the remainder of which is provided and retained within the interior of the core320. The diagnostic assembly according to this embodiment includes a rotatable ejector rod356having a proximal end361that extends initially from the proximal end325of the elongate tubular member324and the recess341of the hollow proximal conical portion340. An opposing distal end364of the ejector rod356extends into the distal end of the core320and is configured to engage the sample collecting device360, such as a brush having a series of distally disposed bristles376. According to this embodiment, the sample collecting device360includes a proximal or coupling end that includes a pair of keys370or other connecting means that engage with corresponding slots or keyways368that are formed in the distal end of the core320.

According to this embodiment, the distal end of the ejector rod356is further configured to support an imaging assembly384, as shown most specifically inFIG. 18, including an electronic imager disposed in relation to the bristles376of the sample collecting device360as well as a plurality of LEDs388that are circumferentially disposed as a ring about the imager to provide sufficient illumination of the target of interest. Preferably, the bristles376of the sampling device360are made from a non-reflective material in order to more efficiently illuminate the target of interest (e.g., cervix) for viewing wherein the imaging assembly includes a wired or wireless connection in order to transmit images. The imaging assembly384and the illumination assembly388can be powered by means of a battery (not shown) using, for example, a USB connection. Alternatively, self-contained power sources can be provided.

According to this embodiment, the imaging assembly384, including the shaft, is prevented from inadvertently retracting from the proximal end of the device300by means of a retainer350that is disposed between the elongate tubular member325of the outer sleeve304and the outer surface of the shaft356, the retainer350having a compressive clamp354at a proximal end thereof.

In a deployed position, shown inFIG. 16and after the diagnostic device300has been implanted into the body cavity (e.g., the vagina) of a patient (not shown), the core320is advanced axially toward the distal end of the outer sleeve304, which advances a portion of the sample collecting device360, including the bristles376, through a formed distal opening of the outer sleeve304and further positions the imaging assembly384at the distal opening of the outer sleeve304. According to this embodiment, axial movement proceeds until the stop surface316engages the second spaced stop groove348, the latter groove348being disposed adjacent the transition of the conical proximal portion340of the core320. In this position, the substantially conical sections312,340of the outer sleeve304and the core320are nested. The core320is then rotated using the engagement member346to enable the sample collecting device360to corresponding rotate about the axis of the core320to collect a suitable sample from the wall of the body cavity and in which the sampling operation can be viewed using the imager assembly384, the latter assembly being fixed and prevented from rotation by the retainer350.

With reference toFIG. 17, the ejection of the sample collecting device360from the diagnostic device300is depicted. In this figure, the outer sleeve is not shown for the sake of clarity. To eject the sample collecting device360the proximal end of the ejector rod356is axially advanced toward the distal end of the diagnostic device300, which advances the ejector shaft against a shoulder of the sample collecting device360and further advances the keys370of the coupling portion from the keyways368at the distal end of the core320. As a result, the sample collecting device360is released from the assembly300and deposited in a suitable sample container44. The recess341of the hollow conical portion340protects inadvertent contact with the ejector rod356when the device300is still in use and prevents premature ejection of the sample collecting device360.

With reference toFIGS. 19A-19C, another retainer version is herein depicted for use with the assembly300. Similar parts are herein labeled with the same reference numerals for the sake of clarity. More specifically, the depicted retainer450is defined by a hollow and substantially tubular structure having respective distal and proximal ends453and456as well as a pair of engaging portions462adjacent the proximal end456that extend radially outward from the tubular structure. Each of the engaging members462according to this embodiment are defined by flexible curved sections that are sized to engage an undercut formed within the recess341of the conical portion340of the core320and compressively engage against the inner surface of the conical section340when fitted with the cabling of the imaging assembly being supported by the hollow tubular structure of the retainer450.

In operation, the sampling device360can be keyed for rotation, as described, when acted upon by the engagement member346in the same manner previously described. During rotation, the imaging assembly384being secured by the retainer450is prevented from rotating. In the meantime, the flexible engaging members462prevent the imaging assembly384from prematurely retracting from assembly300and more specifically proximally from the core320. It will be readily apparent that the number of flexible engaging members can be varied provided the members are capable of providing sufficient radial/torsional force to prevent free axial movement of the imaging assembly484. Upon completion of a sampling operation and as previously discussed, ejection can occur based on inward flexion of the retainer450in combination with axial movement of the imaging assembly384.

PARTS LIST FOR FIGS.1-18

While particular variations and illustrative figures having been used in the foregoing description, those of ordinary skill in the art will recognize that the variations and figures are not intended to be limiting. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with those as would be apparent to a person of suitable skill in the field. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations, which are within the spirit of the disclosure or equivalent to recited features in the claims, it is the intent that this patent will cover those variations as well.