ABSORPTIVE TIP BRUSH BIOPSY DEVICE, KIT AND METHOD

Abstract

A flexible coaxial tissue sampling device, comprising: a sheath; a displaceable wire within the sheath having a first end extending from a proximal end of the sheath and second end which extends, in a first state, from a distal end of the sheath, and in a second state, retracts into the distal end of the sheath; the second end of the displaceable wire comprising a cellular sampling structure and a porous absorptive material which are external to the sheath in the first state and internal in the second state. A tension on the first end of the displaceable wire at the proximal end of the sheath retracts the displaceable wire from the first state to the second state, along with the cellular sampling structure and the porous absorptive material. The porous absorptive material retains a fluid sample after retraction and protects against contact of the sample with other tissues.

Claims

1. A flexible coaxial tissue sampling device, comprising: a sheath having a wall and a hollow space inside the wall; a displaceable wire within the hollow space, the displaceable wire having a first end extending from a proximal end of the sheath and second end configured, in a first state, to extend from a distal end of the sheath, and in a second state, to retract into the distal end of the sheath; the second end of the displaceable wire comprising a suction element, a cellular sampling structure, and a porous absorptive material, wherein the cellular sampling structure and the porous absorptive material are external to the sheath in the first state and internal to the sheath in the second state and the suction element is proximal to the cellular sampling structure and the porous absorptive material; the flexible coaxial structure being configured such that a tension on the first end of the displaceable wire at the proximal end of the sheath results in a retraction of the displaceable wire from the first state to the second state, to cause a displacement into the sheath of the displaceable wire and a corresponding proximal displacement of suction element, the cellular sampling structure, and the porous absorptive material, with suction of media external to the sheath into the distal end of the sheath, the porous absorptive material being configured to retain a fluid sample obtained in the first state after transition to the second state.

2. The tissue sampling device according to claim 1, wherein the porous absorptive material caps the second end of the displaceable wire and protects tissue from damage by a tip of the displaceable wire.

3. The tissue sampling device according to claim 1, wherein the porous absorptive material is formed at a tip of the second end of the displaceable wire.

4. The tissue sampling device according to claim 1, wherein the porous absorptive material in the second state and the sheath protect a biopsy sample within the sheath obtained during transition from the first state to the second state from contamination during withdrawal of the distal end from a patient.

5. The tissue sampling device according to claim 1, wherein the porous absorptive material is adapted for absorbing a biopsy sample for nucleic acid analysis.

6. The tissue sampling device according to claim 1, wherein the porous absorptive material is a sponge.

7. The tissue sampling device according to claim 1, wherein the cellular sampling structure comprises a brush.

8. The tissue sampling device according to claim 7, wherein the brush comprises a plurality of bristles extending radially from the displaceable wire.

9. The tissue sampling device according to claim 1, wherein the coaxial structure is configured to be inserted through an internal cervical os of a uterus of a human to retrieve an endometrial biopsy sample, having a depth adjustable during a biopsy procedure while the coaxial structure is maintained in the first state, by sliding of a depth stop on the sheath.

10. The tissue sampling device according to claim 1, wherein the coaxial structure is configured to be inserted to a determined depth through an internal cervical os of a uterus of a human, to retrieve an endometrial biopsy sample, and to be withdrawn from the cervix.

11. The tissue sampling device according to claim 10, wherein the coaxial structure is further configured to be: inserted into the cervical os with the displaceable structure in the second state to a predetermined depth; extended into the first state with the cellular sampling structure within the uterus; manipulated by a user by movement of the first end of the displaceable structure to dislodge cells within the uterus; retracted into the second state within the uterus, to cause the vacuum to withdraw a liquid sample surrounding the cellular sampling structure in to the distal end of the sheath; and retracted from the cervical os with the displaceable structure in the second state.

12. The tissue sampling device according to claim 1, wherein the cellular sampling structure comprises a spirally twisted steel wire with bristles extending therefrom, welded to a proximal guidewire.

13. The tissue sampling device according to claim 12, wherein the porous absorptive material formed at the second end comprises a urethane foam provided over a cap terminating the spirally twisted steel wire.

14. The tissue sampling device according to claim 1, wherein the sheath has an outer diameter of about 0.15″ and a length between 20 and 50 cm.

15. The tissue sampling device according to claim 1, further comprising a slidable skirt stopper provided on an exterior surface of the flexible sheath, configured to prevent insertion of the flexible sheath within the uterus of a patient beyond an axial location of the skirt stopper.

16. The tissue sampling device according to claim 1, comprising: at least two flexible coaxial structures, each having a respective sheath, a respective displaceable wire, a respective suction element, a respective cellular sampling structure and a respective porous absorbent material; and a housing, configured to selectively engage and disengage a respective displaceable wire of a respective flexible structure to a user interface, such that when engaged, tension and compression are passed from the user interface to the displaceable structure to transition the displaceable structure between the first state and the second state, and when disengaged, tension and compression are not passed from the user interface to the displaceable structure.

17. The tissue sampling device according to claim 1, further comprising an electrical motor configured to move the displaceable structure.

18. A flexible coaxial tissue sampling device, comprising: a sheath having a wall and a hollow space inside the wall; a displaceable wire within the hollow space, the displaceable wire having a first end extending from a proximal end of the sheath and second end configured, in a first state, to extend from a distal end of the sheath, and in a second state, to retract into the distal end of the sheath; the second end of the displaceable wire comprising a cellular sampling structure and a porous absorptive material, wherein the cellular sampling structure and the porous absorptive material are external to the sheath in the first state and internal to the sheath in the second state; the flexible coaxial structure being configured such that a tension on the first end of the displaceable wire at the proximal end of the sheath results in a retraction of the displaceable wire from the first state to the second state, to cause a displacement into the sheath of the displaceable wire, the cellular sampling structure, and the porous absorptive material, the porous absorptive material being configured to retain a fluid sample obtained in the first state after transition to the second state and to protect tissue from contact with the second end of the displaceable wire.

19. The tissue sampling device according to claim 18, wherein the cellular sampling structure comprises a brush having a plurality of radially extending bristles from the displaceable wire and terminating in the porous absorptive material comprising an atraumatic bulb, covered by an open cell foam layer. further comprising a suction element displaceable with the displaceable wire and proximal to the cellular sampling structure and the porous absorptive material, configured to create a negative pressure within the sheath distal to the suction element when the displaceable wire is withdrawn into the sheath.

20. A biopsy method, comprising: providing a flexible coaxial structure comprising a sheath having a wall and a hollow space inside the wall; a displaceable wire within the hollow space, the displaceable wire having a first end extending from a proximal end of the sheath and second end configured, in a first state, to extend from a distal end of the sheath, and in a second state, to retract into the distal end of the sheath; the second end of the displaceable wire comprising a cellular sampling structure and a porous absorptive material, wherein the cellular sampling structure and the porous absorptive material are external to the sheath in the first state and internal to the sheath in the second state; inserting the distal end of the sheath through a cervix, past the internal cervical os, into a uterus, while the flexible coaxial structure is in the second state; pushing the first end of the displaceable wire into the sheath, to cause the flexible coaxial structure to assume the first state; manipulating the displaceable wire to obtain a cellular sample with the cellular sampling structure rubbing against the endometrium and the porous absorptive material absorbing fluid while protecting the endometrium from intrusion by a tip of the displaceable wire; applying a tension on the first end of the displaceable wire at the proximal end of the sheath to cause a retraction of the displaceable wire from the first state to the second state, and consequent withdrawal of the displaceable wire, the cellular sampling structure, and the porous absorptive material into the sheath, while retaining the absorbed fluid in the porous absorptive material; and capping the distal end of the sheath with the porous absorptive material to prevent contamination of a biopsy sample retained on the cellular sampling structure by cells within the cervix and vagina.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0162] FIGS. 1 and 2 show a first embodiment of the biopsy device according to the present invention with a cylindrical sponge cap in the retracted and extended state.

[0163] FIGS. 3 and 4 show a prior art Tao Brush in the retracted and extended state with respect to the sheath, respectively;

[0164] FIGS. 5 and 6 show a second embodiment of the biopsy device according to the present invention with a round cap, in the retracted and extended state;

[0165] FIG. 7 shows transfer of the biopsy sample to a tube containing brush cytology preservative;

[0166] FIGS. 8A and 8B show a Pipelle endometrial biopsy device of the prior art, in the extended and retracted states, respectively;

[0167] FIGS. 9 and 10A-10C show a prior art endometrial biopsy brush with suction, according to U.S. Pat. Nos. 9,351,712, 8,920,336, 8,517,956, and 8,348,856;

[0168] FIG. 11 shows a guidewire and biopsy brush according to the present invention with a sponge covering an atraumatic bulb;

[0169] FIG. 12 shows a narrow sheath with skirt stopper installed according to the present invention;

[0170] FIG. 13 shows a complete biopsy device with manually operable handle, skirt stopper, sheath, guidewire, brush, O-ring, and a sponge covering an atraumatic bulb according to the present invention;

[0171] FIG. 14 shows an arrangement of an independently controllable, biopsy multiple sample, biopsy device showing four similar biopsy sampling tools;

[0172] FIG. 15 shows an arrangement of an independently controllable, biopsy multiple sample, biopsy device showing four different biopsy sampling tools;

[0173] FIG. 16 shows a detail of a selector which permits manipulation of a single biopsy sampling tool in a barrel cartridge;

[0174] FIG. 17 shows a shirt stopper according to the present invention;

[0175] FIG. 18 shows a side perspective view of a prototype biopsy device, having an absorptive sponge material at the distal tip of the biopsy device, with a schematic representation of absorption of a sample;

[0176] FIG. 19 shows a specimen collection container, with a pocket to retain the biopsy brush;

[0177] FIG. 20A shows insertion of a prior art biopsy tool into the uterus;

[0178] FIG. 20B shows manipulation of a prior art biopsy tool into the uterus for tissue sampling;

[0179] FIG. 20C shows withdrawal of a prior art sampling brush into a sheath for subsequent removal from the uterus;

[0180] FIG. 21A shows a side view of vaginal canal/uterus in cross section;

[0181] FIG. 21B shows that the device according to the present invention travels into the vaginal canal, enters cervix, and stops when the skirt touches the cervix with the brush encased within the sheath inside the uterus; and

[0182] FIG. 21C shows the brush extending in full length of the inside the cavity of the uterus, with an absorptive sponge covering an atraumatic bulb and the distal tip.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Example 1

[0183] A preferred embodiment of the present invention consists of an intrauterine biopsy device having an outer thin walled tube of approximately 2.25 mm outside diameter and 1.2 mm inside diameter; length is between 20-50 cm, e.g., 22 cm. This tube may be a clear, bendable but self-supporting plastic tube, made e.g., of nylon. The guidewire is preferably a twisted stainless steel wire of approximately 0.1-0.2 mm diameter, having sufficient mechanical properties to convey the forces for extension and retraction of the brush during use. At the distal end of the guidewire is a biopsy brush, shown in FIGS. 8 and 11, tipped with an atraumatic bulb. The brush may be about 4 cm long, and extend about 2 cm past the end of the sheath when extended. The O-ring preferably remains within the sheath over the entire range of travel, to avoid problems re-engaging the end of the sheath. For example, the O-ring (or more generally, plunger attached to the wire) may be, for example, 2-5 mm from the end of the sheath when extended.

[0184] An anal biopsy device may also be provided, having an outer thin walled tube of approximately 2.25 mm outside diameter and 1.2 mm inside diameter; length is between 8-12, e.g., 8 cm. This tube may be a clear, bendable but self-supporting plastic tube, made e.g., of nylon. The guidewire is preferably a twisted stainless steel wire of approximately 0.1-0.2 mm diameter, having sufficient mechanical properties to convey the forces for extension and retraction of the brush during use. At the distal end of the guidewire is a biopsy brush, shown in FIGS. 8 and 11, tipped with an atraumatic bulb. The brush for the anal biopsy device may also be 4 cm long, with the O-ring or plunger 2-5 mm from the end of the sheath when the brush is extended.

[0185] The wire may be periodically marked, such as in 1 cm increments, so that the physician or biopsy device operator can estimate the brush insertion with respect to the proximal end of the sheath.

[0186] At one end, the one that enters the uterus or anus, the biopsy brush is formed. A tight-fitting O-ring around the guidewire, similar to that shown in FIGS. 10A-10C, acts as a piston and creates the suction as the obturator is withdrawn through the outer thin walled tube.

[0187] In another embodiment, the O-ring may be disposed about 2.5 cm from the tip, with the brush extending about 1.5 cm from the tip, with 1 cm of bare wire between them.

[0188] As shown in FIGS. 9, 10 and 11, a skirt stopper is provided about the exterior of the thin walled tube, near the distal end, which may be in fixed position or manually slidable. The skirt is approximately 1 cm in diameter, and may be formed of nylon, polyurethane, silicone, neoprene, or other medically acceptable plastic or rubber. Typically, the skirt is fixed in position, and may be glued (e.g., UV activated methyl-methacrylate adhesive) or molded to the sheath in position.

[0189] The biopsy device is use as follows:

[0190] The brush is retracted completely into the outer sheath.

[0191] The sheath is inserted, through the vagina, into the cervix, until the skirt stopper meets the external os of the cervix. The tip of the brush should be displaced from the fundus.

[0192] The outer sheath is pulled back until it stops, i.e., abuts the handle. The brush is then rotated by holding the sheath still and turning the handle. For example, the brush may be rotated in a clockwise manner until a reference mark on the handle indicates completion of a 360° turn, and then rotated counterclockwise until the reference mark on the handle indicates completion of a −360° turn. Alternately, the brush may be rotated in only one direction by completing 4 or 5 360° rotations. In some cases, the brush may be repositioned axially, though it should not be withdrawn into the sheath until the sampling is completed.

[0193] After sampling with the brush, the guidewire is pulled at the handle, until the sheath hits the stop (e.g., the edge of the handle), thereby suctioning fluid surrounding the tip into the sheath, and then withdrawing the brush into the sheath.

[0194] After withdrawal of the device from the vagina, the brush and fluids in the sheath are immersed in a cytology preservative, such as formalin, and the sample is washed from the brush into the preservative by moving the brush in and out of the sheath immersed in the fluid.

[0195] The invention may be used, for example, to sample the inside of the uterus to diagnose abnormalities. It can detect or exclude a cancer. It can obtain an adequate tissue sample to determine infertility causes.

[0196] The anal brush is similarly employed. Such a biopsy tool typically has a shorter sheath and guidewire than an endocervical brush biopsy tool, because of the easier anatomical access. For example, the sheath may be 10-15 cm long, and the brush may extend 2-6 cm beyond the end of the sheath. As with the endocervical brush biopsy tool described above, a skirt is preferably provided which prevents insertion of the sheath into the anus beyond the sheath, to provide a physical reference distance for insertion. In some cases, the skirt may be repositioned on the sheath, to permit the physician the ability to determine at what depth of insertion the sample should be acquired. Advantageously, the readjustment requires more force than would be available by applying an unconstrained compression of the sheath against the skirt stopper, so that the position is maintained during use, but the stiction force can be overcome when the biopsy tool is external to the body.

[0197] A rough absorptive tip may be provided to abrade the uterine surface and absorb a liquid sample during the biopsy.

Example 2

[0198] According to a second embodiment, a multiple sample biopsy device is provided, capable of obtaining and segregating a plurality of biopsy samples taken in a single session. This therefore requires a plurality of biopsy brushes or tools, and a plurality of sheaths in which the tools are extended and retracted.

[0199] As discussed above, a depth of insertion positional reference, such as a skirt stopper may be provided. However, where the multiple biopsy tool system has a mechanism maintained outside of the orifice, the diameter of the tool may be sufficiently large to act as the stopper without additional structures.

[0200] According to one design, each biopsy tools is separate, including a sheath and guidewire control. A set of biopsy tools are aggregated in an outer tube housing. The tube has a conical internal profile at the distal end, so that a single biopsy tool may be advanced past the end of the housing, into the orifice or canal from which a biopsy is to be taken. In some cases, endoscopic guidance of the biopsy is desired, and in that case, a second sheath which supports the endoscope and lighting may be advanced as well. The endoscope sheath may also inject saline for visualization, though in the case of a brush biopsy, this is disfavored, since the saline will wash away the dislodged cells, and reduce the positional accuracy of sampling. An inert gas, such as CO.sub.2 may also be injected through the sheath, in known manner.

[0201] One or more tools may have a rough absorptive tip may be provided to abrade the uterine surface and absorb a liquid sample during the biopsy.

[0202] For example, the biopsy brush may be provided in a 3 mm tube, with 6 separate brushes provided within a housing. A stop may be provided at the proximal end of each sheath within the housing, to prevent over-withdrawal. Markings may be provided on each sheath, to inform the physician about the depth of insertion. In some cases, the physician may intend gradated sampling at a series of depths in the orifice, and advantageously, each respective sheath may have a stopper which limits its depth of insertion, and provides the physician with haptic feedback when that depth is achieved. This stopper may be a simple O-ring or clamp, which is adjusted by the physician for each biopsy sampling tool, before the procedure. The guidewire for each sampling tool may also have depth limits. Of course, the retracted position with the biopsy tool fully withdrawn into the sheath represents one extreme, and a clamp or limit may be provided on the manipulation end to control how far the guidewire may be extended beyond the end of the sheath.

[0203] In this first design, each biopsy brush may be of known type, with the optional addition of the insertion and retraction limiters, and an optional absorptive tip, and indeed, the housing for arranging a multiple biopsy sample session may itself may be provided independent of the biopsy brushes.

[0204] Note that the absorptive structure need not be at the extreme tip, and in fact may be displaced in some cases.

[0205] In general, the larger housing diameter avoids the need for a separate skirt stopper, though the housing may terminate in a skirt stopper.

Example 3

[0206] According to a second design of the multiple sample biopsy device, a single manipulator extends from a housing, which itself contains a plurality of biopsy tools.

[0207] As discussed above, a depth of insertion positional reference, such as a skirt stopper may be provided. However, where the multiple biopsy tool system has a mechanism maintained outside of the orifice, the diameter of the tool may be sufficiently large to act as the stop without additional structures.

[0208] Thus, a selectively engageable coupling is provided between a single guidewire and the various tools. The coupling thus links the guidewire, that extends to a physician manipulation interface, such as a grasping element, a handle, or a pivotal mechanism, to the individual guidewire for each tool. Advantageously, the plurality of tools are provide in a rotating barrel, which serves as the housing. Each biopsy tool, when engaged with the manipulation guidewire, can be advanced with its respective sheath an insertion distance, and then the biopsy head advanced beyond the sheath, and twisted or otherwise manipulated to obtain a biopsy sample. The biopsy head is then withdrawn back into the sheath, the sheath with biopsy head covered then withdrawn back into the cartridge, and the barrel twisted so another biopsy tool may then be engaged.

[0209] Therefore, the coupling is a coaxial coupling, which separately links and controls the sheath and the guidewire within each respective sheath. For example, within the cartridge, the end of the sheath may terminate in a steel ring, which is magnetically permeable. Thus, a magnetic coupling can be used to connect and disconnect the sheaths. Further, the inactive biopsy tools may also be held in place by another magnet, which is typically an electromagnet, or a permanent magnet with an electromagnetic release. The guidewire may be selectively connected to the external manipulation guidewire with a spring-loaded clamp. As the barrel is turned, the spring-loaded clamp releases, and re-engages as it reaches the next detent position with the next biopsy tool aligned with the spring clamp. Within the barrel, the guidewire from the biopsy tool extends beyond the proximal end of the respective sheath.

[0210] The barrel is typically at least as long as the desired depth of insertion of the sheath into the patient. Thus, if it is desired to have a 12 cm depth of insertion, the barrel mechanism may be 13-16 cm long.

[0211] As shown in FIG. 14, a plurality of similar brushes are provided in a cartridge. In FIG. 15 a plurality of different brushes are provided in the cartridge. The cartridge has an exit port for the engaged biopsy tool. Each brush has its own associated sheath, which may be independently advanced into the patient, depending on which tool is engaged. A mechanism at the proximal end of the housing controls the selection of the barrel position by an angle of rotation, the latching of the sheath of the respective active tool to the tool advancement control, the clamping of the guidewire of the respective active tool to the guidewire control for manipulation by the physician, and in some cases, other controls, such as deflection angle of the sheath.

[0212] FIG. 16 shows an end view of a portion of the mechanism in the barrel, wherein one guidewire is free to be manipulated by the physician, while access for manipulation of the other guidewires is locked out.

[0213] FIG. 14 shows a bulb provided just proximal to each sampling brush, which is provided to draw a sampling vacuum when the respective brush is withdrawn back into the sheath.

[0214] In FIG. 15, only one biopsy tool has such a feature. The biopsy sampling tools, may be, for example, an endocervical sampler, an endometrial sampler, a punch sampler, and an endometrial sampler with suction.

[0215] In some cases, the sheath itself may be articulable or angularly guidable to direct the biopsy tool to a desired region. The articulable sheath may be a single axis, i.e., a curvature of the end of the sheath, typically as a result of a tension on a tensile element such as cable, guidewire or filament attached to the wall of the sheath, not shown in in the figures . . . . By controlling the angle of curvature, and the rotational angle of the sheath with respect to the organ, a reasonable range of control is provided. Similarly, a punch, or snare, or encapsulating biopsy device may also be controlled by a tension, which may be a wire or polymer filament. Thus, the case of a single guidewire with a single degree of freedom (advance/retract) is a simplest case, and additional controls and degrees of freedom may be provided. Note that an SMA actuator may also be used to alter the tension. The controls for these tools may also be selectively engaged through a mechanism, or provided individually to the user.

[0216] An endoscopic imager (not shown in the figures) may be provided, preferably as a feature of the housing, so that it may be used with various biopsy tools within the housing. For example, a 1-3 mm endoscopic camera with fiber optic or direct LED lighting, may be provided, e.g., the On Semiconductor OVM6946 1/18″ 400×400 imager.

Example 4

[0217] FIG. 18 shows a side perspective view of a prototype biopsy device, having an absorptive sponge material at the distal tip of the biopsy device. A longer foam tip allows for more fluid absorption but requires that the brush is shorter for the same length device. The foam may have a length of 0.25″. The absorptive foam tip is placed over an acrylic ball at the end of the guidewire, which is free from bristles for the length of the foam. The foam may be attached to the brush by using FEP heat shrink to compress the proximal end of the foam, and applying UV glue (Loctite 4011 or 4306 or AA 3979) prior to removing the heat shrink.

[0218] The sheath has an OD of 0.150″. When retracted, the maximum fluid sample drawn by the vacuum was 0.51 ml. The volume absorbed by the foam tip was 0.03-0.05 ml for water and 0.62-0.72 for 5000 cSt fluid.

[0219] The brush may be straight natural 6-12 Nylon filament, on a 304SS core, terminated in an acrylic ball. The twisted wire for the brush is welded to the core wire proximate to the brush. The dimensions of a preferred embodiment are as follows:

[0220] Brush Diameter: 0.118″±0.010″, Brush Length: 1.25″±0.125″

[0221] Overall Length: 12″±0.125″, Distance from Tip to Bristles: 0.25″

[0222] Core Wire 304SS spring tempered, Diameter: 0.018″

[0223] Twisted Wire 304SS Diameter 0.037″

[0224] Bristles Straight Natural 6-12 Nylon Filament 0.003″ Single Stem/Single Spiral, angled at 45 degrees from the core wire

[0225] Acrylic Ball on Tip: 0.055″±0.015″ Diameter

[0226] The handle is, e.g., textured and ergonomically shaped with a concave profile, Tecoflex 60D with 20% BaSO.sub.4, about 1.5″ long and 0.313″ diameter.

[0227] The skirt is polycarbonate (Calibre 2061) or silicone, 0.787″ diameter, 0.742″ long, with a biconic intersection profile with angles of 30° and 60°, and smoothed edges.

[0228] Nusil Med-360 silicone fluid, 1000 cP, may be used to lubricate the sheath, and seal the vacuum draw mechanism. The plunger for drawing vacuum is 0.118″ long, 0.135″ diameter formed of NuSil-4970 silicone, and has sealing surfaces at each end with a central recess. The plunger is compression fit around the wire, proximal to the brush.

[0229] The foam tip is, for example, a urethane foam, which in a prototype was obtained from a Puritan 1135 Purswab® foam-tipped applicator (Puritan Medical Products Co., Guilford, Me.), though in practice, will be custom made.

[0230] The device is designed to maximize cell collection during the biopsy process in doctor's office. It combines global endometrial disruption using a brush, with a built-in suction process and absorption, created by a sponge. A series of tests allowed selection of an optimal brush. It has a smaller diameter, compared to its competitors (0.118″±0.010″ and length of 1.25″±0.125″) promoting a reduction in discomfort during the procedure, while providing a satisfactory tissue sampling.

[0231] After tissue disruption is completed, the sponge tip absorbs additional fluid and material and the device creates a vacuum that aspirates further tissue sample into the device sheath. The idea of aspiration differs from suction used in other devices. The suction will not directly obtain the tissue from the uterine wall, and rather it will aspirate the tissue that was previously scraped off the uterine wall by the brush assuring a better patient experience. The sponge tip prevents the puncture of the uterine wall and due to absorption provides additional tissue collection and fluid intake. A guard (e.g., formed of polycarbonate) rests on the cervix during the procedure and prevents over-insertion of the device.

[0232] The procedure proceeds as follows:

[0233] 1. Procedure: Place the patient in lithotomy position, generally shown in FIG. 21A. Gently insert the speculum and open to expose the uterine cervix. FIG. 21A shows a side view of vaginal canal/uterus in cross section. Only the labia, vagina, cervix, and uterus are depicted, as well as an outline of the patient's skin. The position of the pelvis and legs will suggest the patient is in the examination position.

[0234] 2. Assure that the brush is completely retracted into the outer sheath.

[0235] 3. Gently insert the outer sheath of the device though the cervix into the uterus and stop when the skirt (guard) touches the cervix. (FIG. 21B)

[0236] 4. Extend the brush by gentle push of the handle until resistance of the tip is upon meeting the fundus of the uterus. (FIG. 21C)

[0237] 5. Rotate the sampler in a clockwise manner and complete up four or five 360° rotations.

[0238] 6. The sponge on the tip protects the fundus from piercing. It creates additional tissue sampling by absorption of the fluid and the cells from the uterus.

[0239] 7. Pull the handle back. The suction created by the plunger located inside of the sheath provides aspiration of the cells and prevents loss of the sample from the brush.

[0240] 8. Immediately immerse the sample into the preservative solution, see FIG. 7 or FIG. 19.

[0241] 9. Handle the sample and brush as directed by the pathology lab.

[0242] FIG. 18 shows a detail of a tip of the biopsy brush, wherein a sponge sits at the tip of the device, distal to the brush, and provides cushioning of the tip as well as a volume for sampling of cell-containing fluid from the endometrium.

[0243] FIG. 19 shows a specimen collection container, with a pocket to retain the biopsy brush, e.g., after it is cut or severed from the full biopsy device. The specimen collection container may have an RFID, bar code, or 2D bar code (or QR code) for identification. In some cases, the RFID is transferred from the full biopsy device to the specimen collection container with the biopsy brush portion thereof. The pocket may be tamper-evident, and thus provide increased security and authentication through the chain of transport.