Abstract: A medical device for collecting cells includes a perforated tube and a brush disposed therein for collecting cells from tissue adjacent the tube. The tube includes a perforated portion and tissue can be drawn into the perforations in response to a vacuum applied to the tube. The brush can be inserted into the tube with the head portion of the brush aligned with the perforated portion to collect cells form the tissue that has been drawn into the perforations by the vacuum. The brush can be removed from the tube and another brush can be inserted to increase cell collection amounts.

Abstract: The present invention provides systems, devices, and methods for cell collection and/or cell smearing (e.g., on a slide). In particular, provided herein is an cell collection device, a translating slide holder, systems comprising such devices, and methods of use thereof.

Abstract: A medical device for collecting cells includes a rotatable drive wire having a proximal portion, a distal portion, an offset portion of the distal portion, and a head member attached to the offset portion. The drive wire is coupled to an axially translatable rack member via a rotation mechanism that converts axial translation of the rack member into rotation of the drive wire. The offset portion of the drive will rotate eccentrically relative to the longitudinal axis of the drive wire to increase the diameter of the rotation of the head portion. The head portion can contact an inner surface of the body cavity to collect cells, and the eccentric rotation of the head member can limit trauma experienced by the patient relative to traditional scraping of a cell collection brush.

Abstract: A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.

Abstract: In an embodiment of the invention, a frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain tissue biopsy samples. A frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device is narrow and pointed with a hybrid pear shaped diamond facet. Abrasive material can be adhered to the facet.

Abstract: Methods and systems for medical home testing are described. In one embodiment, the device includes a case member, a plunger member, an accumulator member and a handle member. The case member has a first distal end portion and a first proximal end portion. The first distal end portion has a distal opening and the first proximal end portion has an aperture. The plunger member is sized and configured for sliding through the aperture. The plunger member has a second distal end portion configured to slide within the case member. The accumulator member is disposed in the case member adjacent the plunger member. The accumulator member is compressed by the case member and configured for sliding through the distal opening as the plunger slides through the aperture. The handle member is attached to the accumulator member and extends through the plunger member. Other methods and systems are also described.

Abstract: A sample collection kit (10) for detecting the presence of the human papillomavirus in samples containing cervico-vaginal cells. The sample collection kit includes a pre-addressed envelope (12) containing a sample collection device (18) and a specimen processing card (14) having two testing surfaces (40a,40b), one of which is accessible on either side of the specimen processing card. In use, the sample collection device is inserted into the subject's vagina to collect a sample of cervico-vaginal cells and then the sample collection device is wiped against one of two testing surfaces on the specimen processing card to transfer the sample of endocervical cells to the processing card. Next, the subject disposes the specimen processing card in the pre-addressed envelope and forwards the pre-addressed envelope with the specimen processing card to a medical testing facility.

Abstract: In an embodiment of the invention, a frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain tissue biopsy samples. A frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device is narrow and pointed with a hybrid pear shaped diamond facet. Abrasive material can be adhered to the facet.

Abstract: A treatment instrument includes an insertion portion and a sample collection portion, wherein the sample collection portion includes a link portion and an advancing/retracting portion and when the advancing/retracting portion is located on a most proximal end side, the advancing/retracting portion and the link portion are connected in the axial direction and thereby become parallel to the insertion portion, when the advancing/retracting portion is located on a most distal end side, a part of the advancing/retracting portion and the link portion overlap and thereby become parallel to the insertion portion, and when the advancing/retracting portion is located between a proximal end portion side and a distal end portion side, the link portion is pushed out in a direction crossing the axial direction of the insertion portion by the advancing/retracting portion and thereby projects from the insertion portion.

Abstract: The present invention relates to a sampling device for sampling a body cavity, in particular for sampling the vagina and/or cervix. The sampling device comprises a tube having two open ends, a sample-collecting member and a plunger. The plunger is inserted in the tube, with the distal plunger end protruding from the distal tube end, and carries the sample-collecting member at the proximal tube end. The plunger is displaceable in the proximal direction in the tube from a retracted introduction position into an extended sampling position. In the introduction position, the sampling member is situated inside the tube and protrudes from the tube in the sampling position.

Abstract: A device for obtaining tissue from the aerodigestive tract is provided. The device may have internal and external folds and a tissue collection surface for collecting a tissue sample from a body lumen, such as the nose or throat. The present invention is also directed to methods of collecting a tissue sample using the devices, described herein.

Abstract: A low pressure sample collection apparatus includes a double-ended cap member having similarly sized plug members extending from opposite sides, a vacuum connection nipple on one side and a shaft connection portion one the opposite, a passage extending through the cap from the nipple to the shaft connection portion, a tubular shaft connected to the shaft connection portion and having a sample collection swab member secured to an outer end thereof, and a container member having one end closed and an opposite end open. The cap member is reversibly plugged into the container either to use the container as a handle or to position the swab within the container for protection. A vacuum source may be connected to the assembly to draw air through the swab. The shaft may have a barrel telescoped thereon for separation of the swab from the shaft without contacting the swab.

Abstract: A unitized apparatus for collection and/or drying and/or transport and/or analysis of a specimen is provided having a desiccant chamber that permits variable quantities of desiccant to be loaded into the device and to allow the desiccant to be recharged within the device without contacting or causing damages to the specimen collected thereon.

Abstract: A tissue collection apparatus maximizes the collection and retention of tissue samples from within a patient. The apparatus comprises a handle with a hollow catheter flexibly extending distally from the handle. A cytology brush is stored within the hollow at a distal end of the cannula, and can be extended and retracted from the cannula by manipulating the handle. The cytology brush has a cylindrical proximal brush, a cylindrical distal brush, and a tissue collection gap longitudinally separating the proximal and distal brushes. The bristles of the brushes can have different material properties and can have an effective diameter greater than the cannula. In use, tissue samples accumulate within the bristles and within the tissue collection gap. When retracted into the hollow of the cannula, the apparatus maximizes the amount of tissue collected by folding the bristles over the tissue collection gap to shield the tissue samples collected within.

Abstract: A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.

Abstract: A system for gathering biological material in a biological cavity comprising a catheter having a first lumen, a balloon, and a second lumen in fluid communication with said balloon. The balloon has a textured outer surface for collecting biological material. At least one device for sampling a bodily tissue, such as a needle, optic or forceps, is disposed in the first lumen. A fluid source in fluid communication with the balloon supplies fluid to the second lumen to inflate the balloon such that the textured outer surface collects additional biological material. The system is particularly useful for collecting samples in the lungs or bronchial airways, such as at a bronchial junction.

Abstract: The invention relates to trans-epithelial frictionally abrasive tissue sampling devices for performing biopsies and methods of inducing an immune response against a pathogen, wherein epithelial cells containing the pathogen are disrupted with the frictionally abrasive tissue sampling device to introduce the pathogen into the bloodstream of a patient.

Abstract: A method for treating lung tissue of a patient is provided. A pathway to a point of interest in a lung of a patient is generated. An extended working channel is advanced transorally into the lung and along the pathway to the point of interest. The extended working channel is positioned in a substantially fixed orientation at the point interest. A tool is advanced though the extended working channel to the point of interest. The lung tissue is treated at the point of interest.

Abstract: A microwave ablation system configured for use in luminal network is provided. The microwave ablation system includes a microwave energy source. A tool for treating tissue is provided with the microwave ablation system. An extended working channel is configured to provide passage for the tool. A locatable guide catheter is positionable through the extended working channel and configured to navigate the extended working channel adjacent the target tissue. The microwave ablation system includes a navigation system that is configured for guiding the tool, extended working channel or the locatable guide through a luminal network following a predetermined determined pathway to the target tissue. One or more imaging modalities may be utilized for confirming placement of the tool within target tissue.

Abstract: A method for treating tissue through a branched luminal network of a patient is provided. A pathway to a point of interest in branched luminal network of a patient is generated. An extended working channel is advanced transorally into the branched luminal network and along the pathway to the point of interest. The extended working channel may be positioned in a substantially fixed orientation at the point interest. A tool is advanced though the extended working channel to the point of interest. Tissue at the point of interest is treated.

Abstract: A tissue sampling device includes a single wire spirally wrapped at its half-length. This wire is partially covered in a hollow flexible tube. Located along the distal end portion of the wire is a brush with bristles that are used for collecting a tissue sample. An atraumatic bulb is located on the extreme distal end of the wire to protect the tissue during insertion. The flexible tube is contained within a sheath to cover the brush during insertion and after tissue collection. The sheath is moved back to expose the brush and allow for collection of a tissue sample. The flexible tube is scored in centimeter gradations to allow measurement of the insertion depth of the device. The atraumatic bulb may be more elongated than round, such as egg-shaped, elliptical, oblong, ovate, ovoid, pear-shaped, bullet-shaped, and the like.

Abstract: A biological sampling device for collecting biological material from within an organism can include a sheath, a collector, a handle, and optionally, an applicator. In a secured position, a collector is within the sheath and/or applicator; in a sampling position, a collector is outside the sheath and applicator. A device can be inserted into an orifice of an organism with a collector being transitioned from a secured to a sampling position, moved via a handle to collect biological material for testing, and subsequently returned to a secured position. A biological sample can be prepared from biological material collected by a biological sampling device, and a biological sample can be tested by application of a testing protocol.

Abstract: An oral care implement includes a collection system for oral fluids. Some embodiments of the implement may include an oral care region having a wearable oral member having a thickness that is reduced during use, a reservoir for retaining an oral fluid, a receiver coupled to the oral member for receiving an oral fluid, and a fluid pathway in communication with the receiver to provide the oral fluid to the reservoir.

Abstract: A biopsy device comprises a probe assembly, a holster assembly, a tissue sample holder, and a manually operated rotation mechanism configured to rotate the tissue sample holder. The probe assembly comprises a cutter configured to sever a tissue sample. The tissue sample holder includes a plurality of tissue chambers configured to receive discrete severed tissue samples. The holster assembly comprises the non-motorized, manually operated rotation mechanism configured to allow a user to align consecutive chambers to successively collect discrete severed tissue samples. The tissue sample holder rotation mechanism may comprise a first button, a first lever, a first pawl, a first ratchet, an indexing shaft, and a first gear, which are all configured to, ultimately, rotate a tissue sample holder. The tissue sample holder rotation mechanism may alternately include thumbwheels, a worm gear, or a ratcheting lever, among other things.

Abstract: A non-lacerational apparatus to collect cells in a body cavity provides a brush with bristles which have an abrading surface for collect a histological sample and method for use of the apparatus.

Abstract: A device, system and method for cytology acquisition which may be performed with a swallowable in vivo device, specifically with a swallowable endoscopy capsule. The swallowable capsule may comprise a rotatable drum, a brush attached onto the drum for brushing against a tissue and acquiring cytology, and a porthole through which the brush may be in contact with the tissue.

Abstract: The present invention provides a fecal specimen collector. The fecal specimen collector consisting of a top cover, a bottle body, a specimen output end and a bottom cover, wherein a lower portion of the top cover forms a sampling end which may be inserted into the bottle body through an upper end of the bottle body, the top cover is connected with the upper end of the bottle body, the specimen output end is hermetically coupled with a lower portion of the bottle body, and the bottom cover surrounds the specimen output end and couples to the bottle body, wherein a convex is formed on the inner center of the bottom cover, and is inserted into a specimen output port of the specimen output end. The fecal specimen collector according to the present application has a small and delicate structure which has the advantages of easy operation, convenient portability and pollution free, etc.

Abstract: In an embodiment of the invention, a frictional tissue sampling device with an expandable balloon and associated abrasive material can be used to obtain tissue biopsy samples. A frictional tissue sampling device with expandable abrasive material can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device can be passes through a catheter into a body canal to sample epithelial tissue.

Abstract: A method and system for guiding at least a portion of a surgical device to a desired position between two tissues in a patient's body involves coupling a guidewire to the device and pulling the distal end of the guidewire to guide at least a portion of the surgical device to a desired position between the two tissues. The surgical device generally includes one or more guidewire coupling members and may comprise a tissue access device. A system may include a guidewire and a surgical device. In some embodiments, a guidewire, a tissue access device, and one or more additional devices to use with the access device may be provided. Methods, devices and systems may be used in open, less-invasive or percutaneous surgical procedures, in various embodiments.

Abstract: A tissue and/or cell sampling device for biopsies having a catheter sized for translation through a lumen on an instrument such as a bronchoscope. An aspiration needle engaged to a control member through the catheter is controllable to remove a core of tissue from a sampling location. Forceps or a brush are translatably engaged within the axial core of the needle and are translatable from the tip of the needle to take tissue and/or cell samples. The device is employable to allow the surgeon to use either sampling device independently, or sequently to allow deep tissue and/or cell samples to be retrieved from the distal end of the core tissue sample retrieved by the needle.

Abstract: A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.

Abstract: A surgical instrument navigation system is provided that visually simulates a virtual volumetric scene of a body cavity of a patient from a point of view of a surgical instrument residing in the cavity of the patient, wherein the surgical instrument, as provided, may be a steerable surgical catheter with a biopsy device and/or a surgical catheter with a side-exiting medical instrument, among others. Additionally, systems, methods and devices are provided for forming a respiratory-gated point cloud of a patient's respiratory system and for placing a localization element in an organ of a patient.

Abstract: The present invention relates to a sampling device for sampling a body cavity, in particular for sampling the vagina and/or cervix. The sampling device comprises a tube having two open ends, a sample-collecting member and a plunger. The plunger is inserted in the tube, with the distal plunger end protruding from the distal tube end, and carries the sample-collecting member at the proximal tube end. The plunger is displaceable in the proximal direction in the tube from a retracted introduction position into an extended sampling position. In the introduction position, the sampling member is situated inside the tube and protrudes from the tube in the sampling position.

Abstract: Methods and systems for medical home testing are described. In one embodiment, the device includes a case member, a plunger member, an accumulator member and a handle member. The case member has a first distal end portion and a first proximal end portion. The first distal end portion has a distal opening and the first proximal end portion has an aperture. The plunger member is sized and configured for sliding through the aperture. The plunger member has a second distal end portion configured to slide within the case member. The accumulator member is disposed in the case member adjacent the plunger member. The accumulator member is compressed by the case member and configured for sliding through the distal opening as the plunger slides through the aperture. The handle member is attached to the accumulator member and extends through the plunger member. Other methods and systems are also described.

Abstract: A device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.

Abstract: A system for preparing a cytological suspension is based on a fixing solution. The system containing a cytological sample-taking brush and a flask having an opening for receiving the cytological sample-taking brush are detachably fastened to a handle including a brush-receiving filter basket that is at least partially immersed in the a suspension.

Abstract: A combination exo-endocervical sampling device includes a shaft that includes a first end opposite a second end, and a combination exo-endocervical sampler configured to simultaneously collect endocervical cells and exocervical cells. The combination exo-endocervical sampler is coupled to the second end and includes a pair of opposing wings disposed transverse to the shaft and a brush extending from the wings along a central axis of the shaft. Each of the opposing wings includes a plurality of flexible loops configured to collect exocervical cells.

Abstract: A cap for a container is described that is configured to retain a gynecological sample collected with a sampling device. The cap includes a peripheral wall extending between a base and a flange opposite the base, and a diaphragm extending from the base of the peripheral wall. The flange projects beyond the peripheral wall and is configured to seat against a rim of the container. The diaphragm defines a first open area communicating with a second open area that is smaller than the first open area and includes a boundary spaced from the peripheral wall that is configured to detach the distally located sampler from the sampling device.

Abstract: A method for early detection of high-grade pelvic serous cancers, comprising acquiring fallopian tube cells in vivo by exfoliative cytology, and examining the acquired cells for precursors of high-grade pelvic serous cancer.

Abstract: A catheter with a guide wire and handle is provided for sampling an area of interest, such as chorionic villi. The catheter contains a cannula of flexible plastic that is non-pyrogenic and latex-free, and a flexible obturator with an elongate cylindrical handle. The cannula is echogenic and can be easily visualized with visualization or imaging device. In an embodiment, the catheter may be curved manually by the operator to conform to the patient's anatomy and it is inserted through the cervix into a pregnant uterus at 10-13 weeks gestation and placed into the developing placenta under ultrasound guidance and a guide mechanism provided on the handle. In this embodiment, once the catheter has been placed, the obturator is withdrawn and a sample of chorionic villi is removed by applying appropriate pressure to the proximal end of the cannula and slowly withdrawing the cannula from the uterine cavity.

Abstract: A sexually transmitted infection (STI) sampling device includes an elongated shaft that defines a first end separated from a second end, and an absorbent sampler coupled to one of the first and second ends. The absorbent sampler includes an absorbent core disposed on a longitudinal axis of the elongated shaft, and a plurality of fibers extending from the absorbent core. The plurality of fibers is configured to exfoliate and capture cells from a tissue surface of a patient, and the absorbent core is configured to absorb exfoliated cells not captured by the fibers.

Abstract: The present invention relates generally to devices and systems for detecting infection within catheters. In particular, the present invention provides catheter testing systems configured to sterilely collect a biological sample from the interior of a catheter for purposes of testing the biological sample (e.g., for the presence of fibrin, sepsis, etc.).

Abstract: A method of simultaneously collecting exocervical and endocervical cells from a female patient, includes providing a combination exo-endocervical sampling device including a sampler having a pair of opposing wings and a prominence extending from the wings. The opposing wings include a sampling surface and the prominence includes a multiplicity of endless looped fiber pairs distributed axially along a distal end section of the prominence. Each looped fiber pair includes a first loop extending transverse from the shaft and a second loop extending transverse from the shaft. The loops define a void space therebetween configured to capture exo-endocervical cells. The method includes placing the sampling device in contact with a cervix of the female patient, collecting exocervical cells with the opposing wings of the sampling device, and simultaneously collecting endocervical cells with the prominence.

Abstract: A method and cytology device for manually adjusting the depth of endocervical sampling, and simultaneously sampling the endocervical canal and outer cervix using a dual-brush system. The device (38) comprises a primary cone-shaped endocervical sampling brush (40) adjacent to a secondary donut-shaped cervical sampling brush (42). The primary brush handle (52) is joined to the secondary brush handle (54) by means of a slidable rail (78), allowing adjustability of the primary brush length. The desired length and depth are visible by means of aligning incremental markings or measurements on the primary brush handle (80) with the positioning mark on the secondary brush handle (82). The brush handles are fixed in position and stabilized by means of a securing sheath (58), which has a pinch-release option to release or restore the friction existing between the sheath and the brush handles.

Abstract: The subject invention utilizes the characteristics of in vivo tissue impedances to provide an embodiment of a retinal rake capable of providing a visible and/or preferably an audible signal to a surgeon that more clearly indicates which type of tissue(s) is in contact with the retinal rake. A preferred embodiment comprises a handheld, battery operated retinal rake having two electrodes, wherein at least one electrode is the modified retinal rake. Upon contact with different optical tissues, e.g., epiretinal membranes, retinal tissue, vitreous humor, etc., the electrodes detect varying impedances which are translated by onboard circuitry into various signals that indicate what type of tissue, fluid, structure, etc. is in contact with the retinal rake.

Abstract: A system for preparing a cytological suspension based on a fixing solution. The system containing a cytological sample-taking brush and a flask having an opening for receiving the cytological sample-taking brush that is detachably fastened to a handle, and includes a brush-receiving filter basket that is at least partially immersed in a suspension.

Abstract: Disclosed are surgical tools, tool sets and methods for percutaneously accessing and preparing treatment sites within the spine for subsequent treatment procedures. The treatment site may be an inter-vertebral motion segments in the lumbar and sacral regions of the spine. The tool set may comprise introducer tools and bone dilators for accessing and tapping into a targeted site, such as, for example, the anterior surface of the S1 vertebral body. The tool set may also comprise cutters and extractors for preparing the treatment site for subsequent treatment procedures. The tool set may additionally comprise a bone graft inserter, an exchange system, and/or a temporary distraction tool for further preparing the treatment site for subsequent treatment procedures.

Abstract: An endocervical lavage device for retrieving cervical and endocervical cells for cytologic examination and to method(s) for retrieving cervical and endocervical cells and for using the device. The device generally comprises a multi-lumen tube having a proximal end and a distal end. The distal end of the multi-lumen tube is to be introduced into the uterine cavity of a uterus of a female. An inflatable structure is mounted at the distal end of the multi-lumen tube for creating a first seal between the uterine cavity and an internal cervical os of a cervical canal, the cervical canal being defined at its ends by the internal os at an endocervix that leads into the uterine cavity and an external os at an ectocervix. The device further comprises a collecting structure for advancement distally along the tube to engage the ectocervix, to create a second seal about the external cervical os.

Abstract: In an embodiment of the invention, a frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain tissue biopsy samples. A frictional tissue sampling device with a head designed to be rotated without rotating off the designated site can be used to obtain an epithelial tissue biopsy sample from lesions. The device can be otherwise used to sample specific locations. In various embodiments, the head of the device is narrow and pointed with a hybrid pear shaped diamond facet. Abrasive material can be adhered to the facet.

Abstract: The present invention discloses an apparatus for thin-layer cell smear preparation and in-situ hybridization, comprising at least one positioning device and a sealing device. The positioning device comprises at least one first opening. When the positioning device is set on a carrier device, the wall of the first opening and the carrier device form a cavity. The cavity is used to accommodate a cell suspension. The sealing device is provided on the positioning device for sealing the cavity to form an enclosed space.