Patent Application
20190374208
The present technology relates generally to sample collection devices, and more specifically, to cytology devices for the collection of mammalian tissue, and associated systems and methods.
Existing cytology techniques such as Pap Smear tests have been the state of art for decades. The development of minimally invasive methods and devices in recent years has revolutionized the practice of medicine. The ability to quickly obtain high quality samples with little discomfort has generally made such procedures more acceptable. However, obtaining proper samples for diagnostic testing can be a challenge because certain collection areas are difficult to access and may require more intensive collection and biopsy procedures.
Certain sample collection devices in the market may have limitations or drawbacks that prevent adequate sample collection. For example, some devices lack proper protection against contaminates. Additionally, certain devices are complex and difficult to navigate, which can lead to even more poor tissue collection. Further, devices with limited or no tactile feedback often prevent sufficient or adequate collection. Moreover, the length of many devices is not ideal and also leads to unsatisfactory collection. Accessing the proper collection site is also more difficult with some devices since they are too long, rigid, inconsistent, or difficult to control. Some devices may even cause added discomfort to a patient from contact between the device and tissue of the patient. Several collection methods require that a specific area is sampled making the configuration or design of the device a critical feature. Therefore, there remains a need for improved collection devices that can provide high quality samples.
Methods and materials are provided for the collection of biological samples from a patient.
The present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises a flexible tip portion; and an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end of the inner component is configured to be inserted into the lumen of the outer shield assembly at its proximal end and to protrude past the distal end of the outer shield assembly thereby penetrating the flexible tip portion when the outer shield assembly and the inner component are in an assembled configuration. In one embodiment, the sample collection device further comprises a sample component having an abrasive head portion at a distal end, wherein the sample component is configured to be inserted into the lumen of the inner component at its proximal end and to protrude past the distal ends of the inner component and outer shield assembly when the outer shield assembly and the inner component are in an assembled configuration. In another embodiment, the sample collection device further comprises at least one of a vacuum tube, an irrigation conduit, an optical sensor, or a camera. In one embodiment, the inner component comprises a stopper secured or attached to the proximal end for contacting the proximal end of the outer shield assembly and thereby limiting a distance the distal end of the inner component can protrude past the distal end of the outer shield assembly when the outer shield assembly and the inner component are in an assembled configuration. In one embodiment, the flexible tip portion is configured to open when the distal end of the inner component protrudes past the distal end of the outer shield assembly. In another embodiment, the flexible tip portion is unitarily or monolithically formed with the outer shield assembly. In yet another embodiment, the flexible tip portion is rounded and outwardly spreadable relative to the distal end of the outer shield assembly. In one embodiment, the sample collection device further comprises a handle comprising a distal end and proximal end coupled the outer shield assembly. In one embodiment, the sample collection device further comprises a protective barrier secured or coupled to the distal end of the handle. In one embodiment, the abrasive head portion comprises one or more bristles. In another embodiment, the sample component is configured to be inserted into a cavity of a patient to a desired sample collection site in the patient through the lumen of the inner component. In another embodiment, the sample component comprises a threaded portion at a proximal end. In yet another embodiment, the threaded portion of the sample component is configured to securably attach to a threaded fitting. In still another embodiment, when the threaded portion of the sample component is securably attached to a threaded fitting, rotational force applied to the threaded fitting imparts a rotational motion on the sample component. In still another embodiment, the inner component is configured to be releasably secured to the outer shield assembly.
In another aspect, the present disclosure provides sample collection devices comprising an outer shell configured to conform to a finger of a human subject, the outer shell comprising a proximal end and a distal end, wherein the proximal end comprises an opening to receive said finger; and a channel on an interior dorsal surface of the device having a first channel opening in proximity to the proximal end of the device and a second channel opening in proximity to the distal end of the device. In one embodiment, the channel shares a wall or surface with an interior portion of the shell. In one embodiment, the channel is configured to receive a sample component, pretreatment component, or a vacuum tube. In one embodiment, the outer shell is configured to include a molded groove in a bottom or lower portion of the distal end of the outer shell. In another embodiment, the distal end of the outer shell is covered by a moveable flap or cover. In yet another embodiment, the sample collection device further comprises a tab on a top or upper portion of the proximal end of the shell.
In another aspect, the present disclosure provides glove-based sample collection devices configured to be worn on at least a finger portion of a hand of a human subject comprising an inner layer that is protected by at least one outer layer; and wherein the inner layer comprises a sample component positioned in proximity to a distal tip of a finger portion of the inner layer, and wherein the sample component is configured for collecting a sample. In one embodiment, the sample component comprises at least one of plastic, silicone, multiple bristles, abrasive, foam, or an adhesive. In one embodiment, the sample component is configured to be expandable. In one embodiment, sample component is configured to be protected and/or covered by the outer layer during insertion and/or retraction of the collection device into and out of a patient cavity. In one embodiment, the sample component is attached to a string. In another embodiment, the glove-based sample collection device further comprises a stopper component positioned on the outer and/or inner layer, wherein the stopper is configured to prevent the sample component from being inserted farther into a patient cavity. In yet another embodiment, a distal tip of the at least one outer layer is configured to open or release once the sample component is inserted.
In another aspect, the present disclosure provides glove-based sample collection devices configured to be worn on at least a finger portion of a hand of a human subject comprising an inner layer that is protected by at least one outer layer; and a channel on an interior dorsal surface of the outer layer having a first channel opening in proximity to the proximal end of the glove-based sample collection device, a second channel opening in proximity to the distal end of the glove-based sample collection device, and a lumen extending therebetween. In one embodiment, the second channel opening comprises a protective covering. In one embodiment, the channel is configured to receive a sample component, pretreatment component, or a vacuum tube. In another embodiment, the channel is unitarily or monolithically formed with the outer layer. In yet another embodiment, the sample component is configured to be protected and/or covered by the channel during insertion and/or retraction of the collection device into and out of a patient cavity.
In another aspect, the present disclosure provides sample collection devices comprising a flexible sample component configured to conform to a finger of a human subject, the flexible sample component comprising a distal end, a proximal end and a lumen therebetween, wherein an inside surface of the distal end and the lumen are configured to receive said finger; an abrasive head portion on an outside surface of the distal end of the sample component; and a removal component securably attached to the inside surface of the distal end of the flexible sample component. In another embodiment, the sample collection device further comprises a positioning component coupled to the proximal end of the flexible sample component.
In another aspect, the present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises a flexible tip portion; an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the proximal end comprises an opening to receive a finger of a human subject, and further wherein the distal end comprises an abrasive head; and an adaptor configured to be inserted into the lumen of the outer shield assembly at its proximal end and guide the inner component to protrude past the distal end of the outer shield assembly thereby penetrating the flexible tip portion. In one embodiment, the inner component is configured to be releasably secured to the adaptor.
In another aspect, the present disclosure provides sample collection devices comprising an outer shield assembly comprising a distal end, a proximal end and a lumen extending therebetween, wherein the distal end comprises at least one aperture; and an inner component comprising a distal end, a proximal end and a lumen extending therebetween, wherein the proximal end comprises at least one opening to receive a finger of a human subject, and further wherein the distal end comprises at least one abrasive head and at least a portion of the abrasive head is configured to protrude past the aperture of the outer shield assembly. In one embodiment, the sample collection device further comprises a locking mechanism to secure the inner component in the outer shield assembly. In one embodiment, the locking mechanism is at or near the proximal end of the outer shield assembly. In one embodiment, the inner component further comprises a tab that is configured to engage the locking mechanism. In another embodiment, the sample collection device further comprises a release mechanism configured to protrude the abrasive head past the aperture of the outer shield assembly. In yet another embodiment, the abrasive head comprises at least one of bristles, foam, abrasive polymer, or adhesive. In still yet another embodiment, the abrasive head is flexible.
In another aspect, the present disclosure provides sample components comprising a flexible member and an abrasive head having a plurality of abrasive surfaces comprising two or more wires wherein the wires comprise abrasive surfaces. In one embodiment, at least one of the wires is a flexible wire. In one embodiment, the abrasive surfaces comprise the sample component comprises at least one of plastic, silicone, multiple bristles, foam, or adhesive. In one embodiment, the abrasive surfaces comprise multiple bristle portions or sections. In one embodiment, at least one or a portion of the flexible wires comprise bristle portions or sections. In another embodiment, at least one of the wires are configured to expand once inserted into a patient cavity.
In another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein comprising inserting the outer shield assembly and the flexible tip portion into a patient cavity; pushing the inner component through the lumen of the outer shield assembly to protrude the inner component past the distal end of the outer shield assembly thereby opening the flexible tip portion; inserting a sample component through the lumen of the inner component and outer shield assembly until an abrasive head at a distal end of the sample component extends past the distal end of the inner component; and collecting a biological sample from the patient cavity on the sample component.
In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting a finger of a human subject comprising a sample collection device disclosed herein into a patient cavity; inserting a sample component through the channel on the inner dorsal surface of the device until an abrasive head at a distal end of the sample component extends past the distal end of the device; and collecting a biological sample from the patient cavity on the sample component.
In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting at least one finger of a human subject comprising a glove-based sample collection device disclosed herein; pushing the inner layer through the outer layer thereby exposing the sample component on the distal tip of the finger portion; and collecting a biological sample from the patient cavity on the sample component.
In another aspect, the present disclosure provides methods of collecting a biological sample comprising inserting at least one finger of a human subject comprising a glove-based sample collection device disclosed herein into a patient cavity; pushing the sample component through the lumen of the channel until an abrasive head at a distal end of the sample component extends past the second channel opening; and collecting a biological sample from the patient cavity on the sample component.
In another aspect, the present disclosure provides methods of collecting a biological sample comprising positioning a sample collection device disclosed herein into or near a patient cavity with the flexible sample component configured away from the patient cavity such that the abrasive head portion is not exposed; pushing the inside surface of the distal end of the flexible sample component into the patient cavity to expose the abrasive head portion; collecting a biological sample from the patient cavity on the abrasive head portion; pulling on the removal component to retract the abrasive head portion so that the abrasive head portion is not exposed; and removing the sample collection device from the patient cavity.
In yet another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein, comprising inserting the outer shield assembly into a patient cavity; inserting the inner component through the lumen of the outer shield assembly; engaging the inner component with the adapter to guide the inner component; twisting the inner component until an abrasive head at a distal end of the inner component extends past the distal end of the outer shield assembly component; and collecting a biological sample from the patient cavity on the sample component.
In yet another aspect, the present disclosure provides methods of collecting a biological sample using a sample collection device disclosed herein comprising inserting the outer shield assembly into a patient cavity; positioning the aperture of the outer shield assembly on or near a sample for collection; twisting the inner component to expose the at least one abrasive head portion past the aperture of the outer shield assembly; and collecting the biological sample from the patient cavity on the abrasive head portion.
In one embodiment, at least a portion of a sample collection device is pre-lubricated prior to insertion into a patient cavity.
In one embodiment, the methods of collecting a biological sample further comprise imparting a rotational motion on the sample component and/or abrasive head to collect the biological sample from the patient cavity.
The present technology describes various embodiments of sampling collection devices and associated systems and methods for collecting samples (e.g., tissue samples) of mammals or other animals in the diagnostic or other contexts. For example, various sampling (e.g., cytology) collection devices, features, and methods for their use are described herein. The various devices and methods generally employ reduced or minimally invasive technologies in order to collect cytology samples from, for example, the gastrointestinal body of a patient. In several embodiments, for example, a sampling collection device can be inserted into a cavity, e.g., through an anal canal and into a rectum, and introduced to a nearby site (e.g., the cervix, colon, etc. of a patient) that may be investigated for cellular inconsistencies. The present technology also describes systems and methods for collecting samples using rapid collection procedures.
Many diagnostic procedures have been developed over the years which have diminished the need for more severe procedures. Particularly, the Pap Smear screening has paved the way for cervical cancer prevention. Studies have shown that the risk of developing invasive cervical cancer is three to ten times greater in women who have not been screened, demonstrating the importance of these tests and accurate sample collection.
Similarly, for colon cancer screening, a colonoscopy is the state of the art procedure. However, the technique is costly, requires sedation and is lengthy which increases the cost and burden on the healthcare system. Novel procedures such as virtual colonoscopy done via a CT or MRI scan has gained traction but is usually not as widely available or covered by healthcare providers (e.g., health insurance). Additionally, if a virtual procedure detects any abnormalities, generally a conventional colonoscopy must be performed.
Certain details are set forth in the following description and in
Many of the details, dimensions, angles and other features shown in
In the Figures, identical reference numbers identify identical or at least generally similar elements. To facilitate the discussion of any particular element, the most significant digit or digits of any reference number refers to the Figure in which that element is first introduced. For example, element 110 is first introduced and discussed with reference to
The sample collection device 100 includes a proximal end and a distal end, for guiding the sample component 108 into and through a cavity (e.g., an orifice or lumen) of a patient. The outer shield assembly 104 includes a distal end 110 opposite a proximal end 112. In certain embodiments, the sample collection device 100 can be configured to be small enough to held with one hand of a user (e.g., by a doctor, physician, surgeon, or other medical or clinical practitioner). The proximal end 112 of the outer shield assembly 104 includes an opening 114 for receiving a distal end 116 of the inner component 106 to be inserted therethrough. A first body portion (i.e., lumen) 118 of the inner component 106 is configured to travel or extend through a second body portion (i.e., lumen) 120 of the outer shield assembly 104. For example, the second body portion 120 can be an outer tube (e.g., conduit, sheath, etc.) and the first body portion 118 can be an inner tube (e.g., conduit, sheath, etc.) configured to be inserted into and extend at least partially through the outer tube as illustrated and described in more detail with respect to
The distal end 110 of the outer shield assembly 104 includes a movable (e.g., deformable or resilient) tip portion 122. For example, the tip portion 122 can be made from a flexible or other suitable material which can aid in inserting or maneuvering the sample collection device 100 into or through variously shaped anatomical cavities, openings, and conduits. The tip portion 122 can open (e.g., by deforming) when the inner component 106 is inserted though the outer shield assembly 104 until the distal end 116 of the inner component 106 protrudes from the distal end 110 of the outer shield assembly. By opening the tip portion 122, another component (e.g., the sample component 108) may be inserted through the sample collection device 100. The tip portion 122 may be unitarily or monolithically formed with the rest of the outer shield assembly 104 as a single component. In other embodiments, the tip portion 122 and the outer shield assembly 104 can be two separate components.
The second body portion 120 of the outer shield assembly 104 can be connected or coupled to a handle 124. The handle 124 can have a spool-shaped body or other suitable configuration with the opening 114 or channel extending therethrough between first and second ends of the handle 124. The handle 124 may be formed from a flexible or rigid material. The handle 124 may be a single, unitary (e.g., monolithically formed) piece or composed of several pieces assembled together.
A protective barrier 126 can be secured or coupled to a distal end of the handle 124 between the distal and proximal ends 110,112 of the outer shield assembly 104. The protective barrier 126 can prevent the sample collection device 100 from being inserted too deep into a cavity or orifice (e.g., the protective barrier 126 can be greater in diameter than the cavity or orifice to prevent further insertion of the outer shield assembly 104). The protective barrier 126 can also provide protection (e.g., contamination protection) against fluids that may escape or leak out of the cavity or orifice and flow around the circumference of second body portion 120. As illustrated, in some embodiments, the protective barrier 126 can have a rectangular cross-sectional shape. In other embodiments, the protective barrier 126 can have a circular or other suitable cross-sectional shape. The protective barrier 126 can be formed from a flexible (e.g., silicone) or rigid material.
As described above, the first body portion 118 of the inner assembly 106 can be an inner tube (e.g., conduit, sheath, etc.) having proximal and distal ends. The first body portion 118 can be made from a flexible or rigid material. In some embodiments, the first body portion 118 can include one or more slots or grooves 130 to increase flexibility of the first body portion 118. The first body portion 118 can also include a stopper component 128 configured to be secured or attached to a proximal end of the first body portion 118. The stopper component 128 can be configured such that it cannot be inserted into the opening 114. For example, the stopper component 128 can have a diameter greater than the diameter of the opening 114. This can prevent the inner component 106 from being inserted further into the outer shield assembly 104 when the stopper component 128 contacts a proximal end of the handle 124.
During assembly, as the inner component 106 is inserted through the handle 124 and toward the distal end 110 of the outer shield assembly 104, the tip portion 122 of the outer shield assembly 104 will begin to open as the distal end 116 of the inner component 106 is pushed through the tip portion 122. Once the inner component is fully inserted, whereby the stopper component 128 contacts the handle 124, the tip portion 122 is fully opened (e.g., spread or deformed outward). Such features prevent the sample component 108 from directly touching or contacting the tip portion 122 when inserted through the inner and outer assemblies 106,104. The tip portion 122 may be contaminated with fluids or other tissue when the outer shield assembly 104 was first inserted into the cavity or other orifice of the patient. Further, the tip portion 122 may be covered with a lubricant to aid inserting the outer shield assembly 104 that may potentially contaminate any potential sample collected with the sample component 108. The shape or contour of the distal end 116 of the inner component 106 can be rounded, smooth, and/or curved to minimize any sharp edges to facilitate insertion of the inner component 106 through the outer shield assembly 104.
The outer shield assembly 104 (e.g., the tip portion 122) aids in moving tissue away from a potential sample site prior to inserting the inner component 106. Once the inner component 106 is fully inserted into the outer shield assembly 104 (e.g., the stopper component 128 makes contact with the handle 124), the sample component 108 may be inserted into and through the inner component 106. The sample component 108 is inserted until it exits the distal end 110 of the outer shield assembly 104 near the tip portion 122 and into the patient sample site.
In some embodiments, the sample component 108 can be an abrasive sample component configured to be inserted into a cavity of a patient to a desired sample collection site in the patient through the inner and outer assemblies 106,104 to collect a tissue sample. Example sample components or abrasive head portions that can be used with the sample collection devices described herein are described in more detail below with respect to
The interior spaces (e.g., body portions, conduits, sheaths, tubes, the handle 124, the stopper component 128, the protective barrier 126, the tip portion 122, etc.) of the sample collection device 100 can sized to permit passage of other structures and components to be inserted through or along the sample collection device 100. For example, a vacuum tube may be inserted through the sample collection device 100. The vacuum tube may be used to remove liquid, fluid, or other debris (e.g., from the collection site). An irrigation conduit (e.g., for providing liquid, fluid, etc.) to the sample collection site can also be inserted through or along the sample collection device 100 in certain embodiments. In some embodiments, an optical sensor can be used with the sampling device 100 (e.g., with the tip portion 122 or sample component 108) to signal to a user a location of the sample collection device 100 within the patient. In other embodiments, a camera can be used, for example, to provide video of the insertion site. All materials forming the sample collection device 100, sample component 108, and/or other components used with the sample collection device 100 can be biocompatible and approved for use in humans.
Further in some embodiments, the tip portion 122, second body portion 120, protective barrier 126, and/or handle 124 can form a first distinct assembly (e.g., the outer shield assembly 104) and the first body portion 118 and the stopper component 128 can form a second distinct assembly (e.g., the inner component 106). The first and second distinct assemblies can function together and be assembled to form the sample collection device 100 for receiving the sample component 108 or other components.
In other embodiments, the sample collection device 100 includes an integrated hand piece whereby the first body portion 118, the stopper component 128 of the inner component 106 and the sample component 108 (e.g., an abrasive component) are integrated with the tip portion 122, second body portion 120, the protective barrier 126 and the handle 124. This embodiment can control how far the first body portion 118 and/or the integrated sample component 108 are inserted or retracted relative to the outer shield assembly or cavity (e.g., the distance of insertion and retraction). The distance can be controlled by, for example, a slide feature whereby a user can push the slide feature forward to enable insertion and pulls the feature back to enable retraction. The feature can enable the position of the first body portion 118 and/or the integrated sample component 108 to be locked before and/or during sample collection. The sliding feature may reach a point along the handle 124 that restricts the sliding features motion and prevents its return without additional force. For example, it can include an extruded feature that can interfere with or lock the free motion of the sliding feature. In an alternative embodiment, the device can include a mechanism (e.g., a knob that is twisted or turned) which will move the first body portion 118 and/or the integrated sample component 108 forward or backward. The stopper component 128 can have a threaded component which is inserted into the handle 124. By twisting, the threaded component, the stopper component 128 can be moved forward or backward. Other suitable twisting mechanisms can also be used. Another embodiment, includes integrating the sample component 108 with the device 100 such that it may be push fit into the stopper component 128 to temporarily secure the two structures together. However, the sample component 108 can be removed by pulling it away from the stopper component 128. In certain embodiments, the first body portion 118 can be locked in position after the first body portion 118 is inserted to a proper or desired location. Then after the first body portion 118 is secured or locked in position, the sample component 108 can be inserted through the opening 114 and extend through and exit the distal end 110 of the device 100.
Method of Collection with Sample Collection Device
An example method of collecting a sample (e.g., a tissue sample) with the sample collection device 100 can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device 100 can be removed from a packaging or other wrapping that it is stored in. The sample collection device 100 can be pre-lubricated or a physician or other user can lubricate the outer shield assembly 104 (e.g., the second body portion 120 and/or the tip portion 122) before inserting the outer shield assembly 104 into the patient.
The sample collection device 100 (e.g., the outer assembly 104) can be inserted into the patient cavity or orifice until the protective barrier 126 is touching or contacting the patient's body. Next, the inner component 106 is inserted into the outer assembly 104 through the opening 114 until the stopper component 128 contacts the handle 124 and pushes the tip portion 122 (e.g., end flaps) outward. The first body portion 118 of the inner component 106 is sized such that when the stopper component 128 contacts the handle 124, the distal end of the first body portion 118 pushes open or otherwise spreads outwardly the tip portion 122.
The sample component 108 (e.g., brush or other abrasive head portion) is then inserted into a proximal opening of the stopper component 128 and inserted through the inner and outer assemblies 106,104 until a head portion (e.g., abrasive part) of the sample component 108 extends past a distal end of the tip portion 122. The sample component 108 can be pre-marked with dashes or other marks along its body or shaft portion. The marks can indicate the location or distance of the sample component 108 (e.g., how far it extends into the patient or past the distal end of the tip portion 122). For example, a user can insert the sample component 108 a desired length into the patient and/or past the distal end of the tip portion 122 based on the location of the marks and/or which marks are still visible.
If any resistance is met while inserting the assemblies or components, the sample collection device 100 (the outer shield assembly 104, inner component 106, and/or sample component 108) may be repositioned (e.g., removed, re-inserted, moved, etc.) accordingly as human and other animal anatomy may vary (e.g., cavity shape may change). The sample component 108 can then be rotated to collect the sample from the desired sample site within the patient. Once the sample is collected, the sample component 108 can be removed from device 100 (e.g., pulled out). After the sample component 108 is removed, the sample collection device 100 (e.g., the inner and outer assemblies 106,104) may be removed and discarded. In some embodiments, the sample collection device 100 (e.g., the inner and outer assemblies 106,104) can be washed or decontaminated for reuse.
The channel 410 may house and receive a sample component 408 (e.g., an abrasive head portion) configured to extend therethrough and be inserted through a proximal opening (e.g., the opening 414 and/or a proximal opening of the channel 410) and past (e.g., exit) a distal opening 412 of the shell 402. In some embodiments, the sample component 408 can also extend past the distal end 406 of the shell 402 to reach deeper or farther into the cavity of a mammal or other animal (
A bottom or lower portion of the distal end 406 of the shell 402 includes a molded groove 416 (e.g., slot, channel, valley, etc.) that a head or distal portion (e.g., brush) of the sample component 408 can sit or reside in to collect a sample as the shell 402 is moved or rotated in a radial direction by the user's finger. The groove 416 allows the distal end (e.g., head or brush portion) of the sample component 408 to reside in a specific location at the distal end of the shell 402. Such a location is near or proximate a distal tip of the user's finger when inserted into the shell 402 (
The channel 410 also provides a space where the sample component 408 can be protected from contamination (e.g., mammalian tissue) prior to the sample component 408 being used to collect a sample at a desired sample site as described in more detail below. In some embodiments, the channel 410 may be used to insert other types of components to the sample collection site or otherwise into the patient. For example, a pretreatment component such as a foam brush can be inserted therethrough. In other embodiments, the channel 410 can be used to insert a vacuum tube in order to clean out the collection site or area (e.g., a cavity). Once the area is clean, the vacuum tube may be retracted and the sample component 408 can be inserted to collect a sample. Any components inserted into the proximal opening 414 will be positioned outside of the patient cavity. The component 408 can then be inserted through the channel 410 (e.g., beginning at a proximal opening 411) until a distal end of the component 408 exits through the distal opening 412 which will be inside the patient cavity.
In some embodiments, the distal opening 412 is protected and/or covered by a movable flap or cover. The flap or cover can prevent contaminants from entering the interior of the shell 402 through the opening 412 as the device 400 is inserted through the patient cavity. The flap or cover can be pushed or moved open by the sample component 408 or other components as described above when inserted through the opening 412. In other embodiments, a distal end 406 of the device 400 can include a stopper component 413. The stopper component 413 can prevent a component (e.g., the sample component 408) from extending past the distal tip or end 406 of the device 400. The stopper component 413 can also ensure that contact between the finger, device 400, and inserted component (e.g., the head or distal portion of the sample component 408) is maintained throughout the collection process.
In certain embodiments, as illustrated in
The device 400 can include curved or rounded edges to decrease resistance during insertion and increase maneuverability. In some embodiments, the distal end 406 of the device 400 may be designed with extruded geometry to help with removing debris during insertion. The device 400 can be composed of a flexible biocompatible material which may be stretched over the user's finger when being worn or mounted.
The device 400 can include one or more openings in the walls or surfaces of the device 400 (e.g., around the top or upper portion of the device 400) to minimize the surface area contact between the device 400 and the finger. This can simplify placing the device 400 on the finger. In certain embodiments, the device 400 can include an additional activation component 424 (e.g., a thumb rest) for activating the sample component 408 for collection once the finger worn device 400 is inserted into a patient cavity. The activation component 424 can be press fit or otherwise suitably secured onto the sample component 408. In some embodiments, the activation component 424 can be molded onto the sample component 408. For example, the activation component 424 can include a projection or tab at the proximal end of the sample component 408 for providing an additional traction or contact surface to activate the sample component 408 for collection.
In some embodiments, the sample collection device 400 can have a molded feature at the distal end to enable the sample component 408 to slide into a proper or desired location along the device 400 and/or in the patient cavity. The feature can also stop or prevent the sample component 408 from further or deeper insertion.
In certain embodiments, as illustrated in
A protective barrier 3512 can be secured or coupled to a distal end of the outer shield assembly 3500. In some embodiments, the inner component 3504 can be configured to have a tab 3506 on the proximal end of the inner component 3504 which functions to lock or releasably secure the inner component 3504 into the outer shield assembly 3502 when the at least one abrasive head portion 3508 aligns with the 3510 at least one aperture.
Method of Collection with Sample Collection Device
An example method of collecting a sample (e.g., a tissue sample) with the sample collection device 400 can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device 400 can be removed from a packaging or other wrapping that it is stored in. The sample collection device 400 can be pre-lubricated or a physician or other user can lubricate an outer surface of the device 400 before inserting the device 400 into the patient. The device 400 is then placed on the user's finger 418 and inserted into the patient cavity. Once the device 400 is located at the desired tissue sample site, the sample component 408 is inserted through proximal opening 414 of the device 400 and/or the channel 410. The sample component 408 is inserted until it exits the distal opening 412 and reaches the distal end 406 of the device 400 and/or finger. In some embodiments, as described above, the sample component 408 can be inserted past the distal end 406 of the device 400.
For collection, the user moves its finger 418 in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the sample component 408 can be removed from device 400. After the sample component 408 is removed, the device 400 can be removed from the cavity and the user's finger and discarded. In some embodiments, the device 400 can be decontaminated and reused for another sample collection.
An example method of collecting a sample (e.g., a tissue sample) with the sample collection device 3300 can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device 3300 can be removed from a packaging or other wrapping that it is stored in. The sample collection device 3300 can be pre-lubricated or a physician or other user can lubricate an outer surface of the device 3300 before inserting the device 3300 into the patient. The device 3300 is then positioned into or near a patient cavity with the flexible sample component 3302 configured away from the patient cavity such that the abrasive head portion is not exposed, as depicted in
For collection, the user moves its finger in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the user holds that device 3300 in position with one hand on the positioning component 3312 and/or tabs 3314 and pulls the removal component 3310 with its other hand to retract the abrasive head portion 3308 so that the abrasive head portion is not exposed, as in
Another example method of collecting a sample (e.g., a tissue sample) with the sample collection device 3400 can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device 3400 can be removed from a packaging or other wrapping that it is stored in. The sample collection device 3400 can be pre-lubricated or a physician or other user can lubricate an outer surface of the device 3400 before inserting the device 3400 into the patient. The device 3400 is then placed on the user's finger and inserted into the patient cavity. Once the device 3400 is located at the desired tissue sample site, the inner component 3404 is inserted through the lumen of the outer shield assembly 3402 until it engages with the adapter 3412. The protrusions 3424 on the adapter 3412 can guide the abrasive head portion 3410 of the inner component 3404 to protrude past the distal end 3416 of the outer shield assembly 3402 thereby penetrating the flexible tip portion 3418.
Once the sample is collected, the inner component 3404 can be withdrawn back into the outer shield assembly 3402 and the sample collection device 3400 can be removed from the cavity and the user's finger and the outer shield assembly discarded. In some embodiments, the device 3400 can be decontaminated and reused for another sample collection.
An example method of collecting a sample (e.g., a tissue sample) with the sample collection device 3500 can include one or more of the following steps in accordance with an embodiment of the present technology. The sample collection device 3500 can be removed from a packaging or other wrapping that it is stored in. The sample collection device 3500 can be pre-lubricated or a physician or other user can lubricate an outer surface of the device 3500 before inserting the device 3500 into the patient. The device 3500 is then placed on the user's finger and inserted into the patient cavity. Once the device 3500 is located at the desired tissue sample site, the inner component 3504 can be twisted to expose the abrasive head portion 3508 past the aperture 3510 of the outer shield component 3502. The user may move its finger in a radial or circular motion to collect a sample (e.g., a tissue sample). Once the sample is collected, the inner component 3504 may be rotated to retract the abrasive head 3508 back through the aperture 3510. The device 3500 can then be removed from the cavity and the user's finger and discarded. In some embodiments, the device 3500 can be decontaminated and reused for another sample collection.
The bristles 814 can contact the lumen walls of a patient cavity or lumen (e.g., a rectum) to collect a sample. The bristle density may vary along the length of the wire as can the bristle thickness. The diameter and shape of the bristles 814 can be suitably sized and shaped to ensure sufficient contact with the lumen walls for accurate sample collection. During collection, the force exerted by the bristles 814 must be sufficient to ensure abrasion against the lumen walls. Such force can be varied or changed by using a variety of bristle types (e.g., hardness, stiffness, rigidity, diameter), varying geometry or shape, and/or changing flexibility of the twisted wire 812.
Because the shape of a patient cavity (e.g., orifice or lumen) can vary or be irregular, the sample component 808, 908, etc. is flexible enough to bend and make contact with the lumen walls during twisting of the brush and/or movement in the radial and back and forth directions. In some embodiments, a distal end of the sample component 808, 908, etc. may require a smaller diameter bristle 814 length to ease insertion, gently open the lumen, fit into a nook, and/or for brushing to collect a sample (
During insertion, the distal end of the head portion 810 (e.g., bristles 814) will be inserted through the sample devices and initially contact the lumen walls and abrade the surface of the lumen walls. By having smaller diameter bristles 814 at the distal end, the contact with the inner walls of the sample device as the sample component is inserted therethrough is minimized or reduced. This can minimize or reduce any cross contamination between the bristles 814 and device 100, 400, etc.
As illustrated in the various embodiments, the bristles 814 may be arranged in multiple configurations such that there can be sections with varying bristle density (
In certain embodiments, additional materials 1316 can be placed or coupled onto the front or distal end 810 of the sample components. The additional materials can be used to clean or prepare the collection area, protect the channel from contamination, move contaminants or take in contamination (
In some embodiments, sample component 808, 908, etc. can have a generally thin protective cover 1718 that protects the bristles 814, the tip portion 810, and/or any other material along the length of the sample component (
The distal tip of the sample component 808, 908, etc. can be blunt or round as illustrated in the various embodiments (
The sample components can have multiple independent abrasive surfaces. For example, as illustrated in
In some embodiments, The sample component 808, 908, etc. can include a balloon 2120 with multiple extruded fingers 2122 on the outside of the balloon 2120. Once inserted past the distal end of a sample collection device, the balloon 2120 can be inflated. This allows the fingers 2122 to make contact with the lumen walls, whereby when twisted, will abrade the surface (
In some embodiments, the inner layer 2202 can include another material on the distal tip of the finger portion 2208. For example, the inner layer 2202 can be overmolded with a silicone feature or have a silicone feature secured onto the layer with an adhesive. This silicone feature may have ribs, bristles, or other extrusions. One alternative to silicone would be a plastic component which may be fixed to the inner layer 2202 with adhesive. This layer may enable material from being moved away to provide access to a surface (for example, the rectal lining).
The outer layer 2204 is configured to protect and/or cover the abrasive pad 2206 during insertion and retraction of the collection device 2200 into and out of the patient cavity. The collection device 2200 can include a stopper component 2224 (e.g., over-molded ring element) positioned (e.g., extending radially about) on the outer layer 2204 to prevent the collection device 2200 from being inserted farther into patient cavity. In some embodiments, the outer layer 2204 can include multiple layers. For example, the outer layer 2204 can include two or more layers to increase thickness, while still providing flexibility. In other embodiments, the distal tip of the outer layer 2204 may also have an additional layer of material to enable clearing of the sample collection area of fluid or other debris.
In operation, the distal tip or end of the outer layer 2204 distal tip will open during insertion exposing the abrasive pad 2206 (
In some embodiments, the inner layer 2202 may be inserted through a side opening in the outer layer 2204. The outer layer 2204 may have a slit on either side which may be collapsed (e.g., resiliently deforms) when nothing is being forced through. However, if the inner layer 2202, which will have a finger inside, slides through the slit, the outer layer 2204 can expand and open, allowing said inner layer 2202 to extend through the outer layer 2204. The abrasive pad 2206 may then contact the collection area or site to collect a sample.
In some embodiments, the inner layer 2702 can include another material on the distal tip of the finger portion 2708. For example, the inner layer 2702 can be overmolded with a silicone feature or have a silicone feature secured onto the layer with an adhesive. This silicone feature may have ribs, bristles, or other extrusions. One alternative to silicone would be a plastic component which may be fixed to the inner layer 2702 with adhesive. This layer may enable material from being moved away to provide access to a surface (for example, the rectal lining).
The outer layer 2704 is configured to protect and/or cover the sample component 2706 during insertion and retraction of the collection device 2700 into and out of the patient cavity. The collection device 2700 can include a stopper component 2724 (e.g., over-molded ring element) positioned (e.g., extending radially about) on the outer layer 2704 to prevent the collection device 2700 from being inserted farther into patient cavity. In some embodiments, the outer layer 2704 can include multiple layers. For example, the outer layer 2704 can include two or more layers to increase thickness, while still providing flexibility. In other embodiments, the distal tip of the outer layer 2704 may also have an additional layer of material to enable clearing of the sample collection area of fluid or other debris. In operation, the distal tip or end of the outer layer 2704 distal tip will open during insertion exposing the sample component 2706 (
The distal end of the channel 2502 may be open. In some embodiments, the distal end of the channel 2502 may include a protective flap or cover to shield the channel 2502 from contaminants or debris as the device 2500 is inserted into a patient cavity. The channel 2502 is sized to support various components (e.g., a sample component, cytobrush, vacuum conduit, irrigation conduit, cleaner component, etc.) to be inserted through the channel 2502 and into the patient cavity.
The channel 2502 can be comprised of a flexible material. In other embodiments, the channel 2502 can be formed from a suitable rigid material, semi-rigid material, and/or semi-flexible material. The channel 2502 can be a separately formed component that is fixed or secured to the device 2500 by an adhesive or other suitable fastener. In other embodiments, the channel 2502 can be molded as one piece with the device 2500 or cut or formed through a layer of the device 2500.
The distal tip of the finger of the device 2500 has space for the sample component 2508 or other component to rest or reside at the tip whereby a user can provide a force on the sample component 2508. The distal tip of the device 2500 could have a molded end or stopping component to stop or prevent any component from being inserted beyond the distal tip.
From the foregoing, it will be appreciated that specific embodiments of the present technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the scope of the present technology. Specific elements of any of the foregoing embodiments can also be combined or substituted for elements in other embodiments. Furthermore, while advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the present technology is not limited, except as by the appended claims.
This application is a continuation application of U.S. patent application Ser. No. 15/156,056 filed May 16, 2016, which claims priority to U.S. Provisional Patent Application Ser. No. 62/162,309 which was filed on May 15, 2015, the entire contents of which are incorporated herein by reference and relied upon.
This invention was made with government support under R44CA168185, R42CA168055, U01CA111257, and R01CA165309 awarded by the National Institutes of Health. The government has certain rights in the invention.
| Number | Date | Country | |
|---|---|---|---|
| 62162309 | May 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15156056 | May 2016 | US |
| Child | 16241024 | US |
