TISSUE COLLECTION LID FOR A SPECIMEN CUP
PRIORITY
[0001] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/580,499, filed June 17, 2004, which is expressly incorporated by reference as if fully set forth herein.
BACKGROUND
[0002] Sample and specimen cups for collection of tissue and bodily fluids are well known in the art and include, for example, urine collection cups, vacuum containers for blood collection and cups for tissue samples. It is not uncommon for a specimen container to be utilized without a lid or other top thereon during placement of a sample inside. Consequently, while such a specimen container may utilize a plastic lid to seal the cup for transport of the sample(s) to a pathology lab, there is nothing thereon to prevent splashing or escaping of fluid and/or tissue during discharge of a specimen collection instrument. In such a situation, a biologic hazard is created for the instrument user. Therefore, lids for specimen containers have been proposed that incorporate a diaphragm design for a needle, pipette or test strip to enter therein and are generally fashioned to prevent spilling of the fluid or sample from the container as it is being placed inside.
[0003] Examples of various specimen containers and sample cups are shown and described in USPN 2,196,785, entitled "RUBBER STOPPER FOR BOTTLES, JARS, VESSELS, AND LIKE CONTAINERS" issued 04/09/40; USPN 2,436,291, entitled "SELF-SEALING CLOSURE FOR CONTAINERS" issued 02/17/48; USPN 2,957,503, entitled "PILL DISPENSER" issued 10/25/60; USPN 3,478,922, entitled "SELF-CLOSING VAPOR CONTROLLING CAP" issued 11/18/69; USPN 3,629,873, entitled "CONTAINER STRUCTURE" issued 12/18/71; USPN 4,040,791, entitled "SPECIMEN COLLECTING DEVICE" issued 08/09/77; USPN 4,064,760, entitled "STERILE URINE COLLECTION DEVICE" issued 12/27/77; USPN 4,248,355, entitled "CLOSURE FOR SAMPLE VIALS" issued 02/03/81; USPN 4,362,698, entitled "CLOSURES FOR FLUID SAMPLE CUPS" issued 12/07/82;
USPN 4,515,752, entitled "STOPPER FOR CONTAINERS FOR USE IN ANALYSES" issued 05/07/85; USPN 4,863,453, entitled "STERILE CLOSURE DEVICE" issued 09/05/89; USPN 4,998,633, entitled "STOPPER FOR A CONTAINER SUCH AS A BOTTLE AND INCLUDING SLIT VALVE STRUCTURE, FOR USE WITH A PUMP FOR ALTERING AND THEREAFTER MAINTAINING ALTERED PRESSURE IN THE CONTAINER" issued 03/12/91; USPN 5,071,017, entitled "CLOSURE CAP CONSTRUCTION WITH SLITTED FLEXIBLE DIAPHRAGM" issued 12/10/91; USPN 5,088,612, entitled "VIAL CAP" issued 02/18/92; USPN 5,111,946, entitled "SAFETY BOTTLE" issued 05/12/92; USPN 5,169,602, entitled "RESEALABLE CONDUIT AND METHOD" issued 12/08/92; USPN 5,202,093, entitled "SEALING CAP WITH A ONE WAY VALVE HAVING SEMI-CYLINDRICAL VALVE CLOSURE SPRINGS" issued 04/13/93; USPN 5,257,984, entitled "BLOOD COLLECTOR" issued 11/02/93; USPN 5,352,413, entitled "DEVICE FOR THE SAFE REMOVAL OF BLOOD FROM A SUPPLY VESSEL" issued 10/04/94; USPN 5,395,590, entitled "VALVED CONTAINED LID" issued 03/07/95; USPN 5,458,854, entitled "COLLECTION ASSEMBLY" issued 10/17/95; USPN 5,511,557, entitled "URINE SPECIMEN COLLECTION DEVICE" issued 04/30/96; USPN 5,611,792, entitled "VALVE DEVICE FOR ASEPTIC INJECTION AND REMOVAL OF A MEDICAL FLUID INTO/FROM A CONTAINER" issued 03/18/97; USPN 5,753,186, entitled "REACTION TUBE WITH A PENETRABLE MEMBRANE TO MINIMIZE CONTAMINATION" issued 05/19/98; USPN 5,904,677, entitled "STERILE SPECIMEN CAPTURE DEVICE" issued 05/18/99; USPN 6,030,582, entitled "SELF-RESEALING, PUNCTURABLE CONTAINER CAP" issued 02/29/00; USPN 6,054,099, entitled "URINE SPECIMEN CONTAINER" issued 04/25/00; USPN 6,173,851, entitled "METHOD AND APPARATUS FOR THE INTERIM STORAGE OF MEDICATED ORAL DOSAGE FORMS" issued 01/16/01; USPN 6,210,909, entitled "LIQUID SPECIMEN CONTAINER AND ATTACHABLE TESTING MODULES" issued 04/03/01; USPN 6,277,646, entitled "FLUID SPECIMEN COLLECTING AND TESTING APPARATUS" issued 08/21/01 ; USPN 6,286,698, entitled "METHODS AND APPARATUS FOR THE INTERIM STORAGE OF MEDICATED ORAL DOSAGE FORMS" issued 09/11/01; USPN
6,361,744, entitled "SELF-RESEALING CLOSURE FOR CONTAINERS" issued 03/26/02; USPN 6,402,407, entitled "DEVICE FOR HOLDING A WRITING INSTRUMENT" issued 06/11/02; USPN 6,409,970, entitled "BIOPSY COLLECTION SYSTEM" issued 06/25/02; USPN 6,509,164, entitled "LIQUID SPECIMEN CONTAINER AND ATTACHABLE TESTING MODULES" issued 01/21/03; USPN 6,589,749, entitled "LIQUID SPECIMEN CONTAINER AND ATTACHABLE TESTING MODULES" issued 07/08/03; and USPN 6,716,396, entitled "PENETRABLE CAP" issued 04/06/04; each of which is incorporated by reference herein in its entirety.
[0004] Many of the above-referenced patents include sample cups having lid closure devices that utilize rubber bladders, liners, lips, etc. to prevent escape of fluid and/or tissue during discharge of the sample from an instrument inserted therethrough. Such designs may be optimal and preferable for large gauge needles or other small diameter instruments. However, for small gauge needles and other instruments having much larger diameters, such as certain biopsy needles, insertion thereof through a solid material (e.g., rubber gasket, septum, etc.) is not only difficult for the user, but will tend to cut the material, contaminating both the biopsy sample and the needle. Such contamination is problematic, for example, in the case of a biopsy needle due to the fact that in a typical biopsy procedure numerous samples are taken using the same needle.
BRIEF SUMMARY OF THE INVENTION
[0005] Accordingly, described herein is a specimen cup having a tissue collection lid configured to prevent escape of fluid and/or tissue from the specimen cup during ejection of the fluid and/or tissue from a sampling instrument, such as a biopsy needle. In addition, the tissue collection lid is also configured to remove excess fluid and/or tissue remaining in the sampling instrument as the sampling instrument is withdrawn from the specimen cup. The tissue collection lid described herein may be utilized with various types of specimen cups or containers, having different sizes, shapes and materials. The tissue collection lid may be configured to be pressed into an open specimen cup or container, such that the lid forms a fluid tight
seal therewith, or may be otherwise configured to form a sealing connection with a specimen cup or container (e.g., threaded configuration).
[0006] In one aspect, a lid for a container includes a rim defining an opening, the rim including an upper section and a lower section, the lower section being configured for insertion into an open end of a container, and a flange connected to the upper section of the rim, the flange being positioned within the opening, the flange including an aperture and a plurality of slits, the plurality of slits extending radially from the aperture toward the rim.
[0007] In another aspect, a lid for a container includes a rim defining an opening, the rim including an upper section and a lower section, the lower section being configured for insertion into an open end of a container, the rim including means for forming a seal upon insertion of the lower section into an open end of a container, and a flange of different material than the rim, an outer edge of the flange being embedded in the upper section of the rim such that the flange is positioned within the opening, the flange including an aperture and a plurality of slits, the plurality of slits extending radially from the aperture toward the rim, creating a plurality of flange members.
[0008] In one aspect, a tissue collection lid includes a rim and a flange, the rim including an upper section and a lower section, the flange including a plurality of slits extending radially outward from an aperture in a mid-region thereof toward the rim. The rim defines an opening therethrough and the flange is positioned within the opening. The flange in one embodiment is embedded in the upper section of the rim. The slits of the flange may be arranged spaced apart from one another to create similarly shaped flange members that are capable of independent flexing with respect to one another. The flange may be of a different material than the rim and in one embodiment is made of a metal material to reduce the likelihood of contamination. In one aspect, the rim is made of a low density polyethylene material, while the flange is made of a stainless steel material. In another aspect, the lower section of the rim includes gripping barbs arranged around an outer surface thereof to provide a seal with a specimen cup into which it is inserted. In another aspect, the rim is circular in
shape and the upper section has an outer diameter that is greater than that of the lower section.
[0009] In yet another aspect, a method of ejecting a biopsy sample into a specimen cup is provided. The method can be achieved by inserting a distal end of a biopsy needle through a lid of the specimen cup, the lid including a flange with an aperture and a plurality of slits, the plurality of slits extending radially from the aperture toward the rim, creating a plurality of flange members, the biopsy needle being inserted through the aperture, ejecting the biopsy sample into the specimen cup, and removing material disposed in a part of the biopsy needle via at least one of the flange members. In still another aspect, a method of reducing contamination of a biopsy sample is provided. The method can be achieved by providing a plurality of flange members arcuately disposed about a central opening, inserting a biopsy needle having a material hardness equal to or less than the material hardness of the flange members through the central opening, and removing material disposed in a part of the biopsy needle via at least one of the flange members.
[0010] These and other embodiments, features and advantages of the present invention" will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention in conjunction with the accompanying drawings that are first briefly described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a side perspective view of one embodiment of a tissue collection lid and a specimen cup.
[0012] FIG. 2 is a side perspective view of the tissue collection lid of FIG. 1 inserted within the specimen cup.
[0013] FIG. 3 is a top perspective view of the tissue collection Hd of FIG. 1.
[0014] FIG. 4 is side perspective view of the tissue collection lid and specimen cup of FIG. 2, showing a biopsy needle inserted through the tissue collection lid.
[0015] FIG. 5 is a view of the biopsy needle of FIG. 4 being withdrawn from the specimen cup through the tissue collection lid.
[0016] FIG. 6 is a top view of one embodiment of a flange of a tissue collection lid.
[0017] FIG. 7 is a bottom view of a tissue collection lid.
[0018] FIG. 8 is a cross-sectional view of the tissue collection lid of FIG. 7.
[0019] FIG. 9 is an enlarged cross-sectional view of a section of FIG. 8.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected preferred embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.
[0021] The tissue collection lid described herein is designed to serve a number of purposes, depending on the type of instrument used and the application of use. In a medical context, the tissue collection lid is designed, for example, to prevent biologic hazard associated with the splash of biologic fluids, while also aiding in the removal of fluid and/or tissue from a sampling instrument, such as a biopsy needle. The tissue collection lid, as described herein, may optimally be designed for use with an instrument having a biopsy needle of small gauge with a port in a distal end thereof designed to hold a biopsy sample, such as the Bard® Vacora™ Vacuum Assisted Biopsy System, manufactured by Bard Biopsy Systems, a business unit of Bard Peripheral Vascular, Inc. of Tempe, Arizona, which is disclosed in WO 03/077767 and WO 03/077768, each of which is incorporated by reference herein in its entirety.
While the examples provided herein are with respect to use of the tissue collection lid with a biopsy needle, one of skill in the art would appreciate that the tissue collection lid described herein could also be used with various other instruments. Therefore, the scope of the invention should not be limited for use with a biopsy needle instrument, and is not intended to be so limited.
[0022] The tissue collection lid as described herein may be made of different materials and can be fashioned in different shapes and sizes, depending on the shape and size of the specimen cup or other container with which it is to be used. In the embodiment described herein, the tissue collection lid can be circular to fit within a cylindrical specimen cup and can include a rim made of a plastic material (e.g., low density polyethylene) and a flange made of a metal material (e.g., stainless steel). The hardness of the flange material can be less than, equal to or substantially equivalent to the hardness of the biopsy needle. For example, if the biopsy needle is made of 316 stainless steel (Rockwell 'B' hardness of approximately 92) and the flange is made of 304 stainless steel (Rockwell 'B' hardness of approximately 95), the flange hardness is less than that of the biopsy needle. In another example, the flange and biopsy needle are made from materials with approximately equivalent hardness.
[0023] Referring to FIG. 1, a tissue collection lid 10 and specimen cup 20 are shown in a disassembled state. It can be seen from this view that the tissue collection lid 10 includes a rim 12 and a flange 30, the rim 12 including a lower section 16 and an upper section 14. An opening is defined by the inner circumference of the upper section 14 and extends through the rim. In the embodiment shown in FIG. 1, the upper section outer diameter is greater than the lower section outer diameter, while the lower section inner diameter is greater than the upper section inner diameter (FIG. 8). The flange 30 is positioned within the opening of the rim 12. In the assembled view of FIG. 2, the tissue collection lid 10 is placed into an open end of the specimen cup 20. The lower section 16 is pressed into the open end of the specimen cup 20, fitting tightly against the inside wall thereof. In one embodiment, the tissue collection lid 10 can be interference fitted (e.g., slip fit or permanent fit) due to closely toleranced diameters of the lower section and the open end of the container so that a fluid tight seal can be achieved when the tissue collection lid 10 is placed into the
specimen cup 20. Of course, if the specimen cup is formed with a square, rectangle, triangle or other-shaped cross-section, the tissue collection lid would be configured in a similar manner to provide a fluid tight seal. Other configurations for securing the lid to a specimen cup can also be utilized in the examples described herein, such as a threaded arrangement.
[0024] In the embodiment shown, the upper section 14 of the rim 12 is made of the same material as the lower section 16 (e.g., low density polyethylene), the entire rim 12 being manufactured as one unit, for example through an injection molding process. The flange 30, including a plurality of flange members 32, is made of a different material (e.g., stainless steel) in this embodiment, and is embedded in the wall of the upper section 14 by methods known to one of skill in the art, such as by insert overmolding. It should be noted that by fashioning the flange 30 from a metal or other like material, contamination (which would likely occur if the flanges were made of plastic) can be largely avoided or at least significantly reduced. The flange 30 in this embodiment includes flange members 32 in the form of eight triangular or pie-shaped segments, although certainly any number of segments would be possible (three, four, five, six, ten, twelve, etc.). Also, an embodiment of a flange can include a single flange member. In one embodiment, the flange 30 is created by forming an aperture 18 in a solid piece of material and cutting a plurality of slits 34 (e.g-, through laser-cutting, etc.) through a surface thereof around the circumference of the aperture 18 and extending radially outward to a perimeter 36 (FIG. 6). It should be appreciated that although the flange members illustrated herein are of similar shape and size, other embodiments include flange members having different shapes and/or sizes, which may be advantageous, for example, in facilitating removal of tissue from different sized/shaped instruments. In such embodiments, the slits may not be radially oriented. For example, the slits may be cut to form dissimilar flange members.
[0025] The size of the aperture 18 may be adjusted based on the size of the instrument that is intended for insertion into the specimen cup and may be created in the flange 30 by removing through a cutting process, as discussed above. Moreover, the aperture 18 is configured to ensure that an instrument can be easily inserted
through the opening, while simultaneously ensuring that the opening will be sufficiently closed when the instrument is inserted to prevent escape of fluid and/or tissue therethrough. Further, while the aperture 18 shown in the tissue collection lid 10 is circular, it should be appreciated that any shape or size is possible, depending on the shape and size of the instrument intended for insertion therethrough. The slits 34 defining flange members 32, as seen best in FIGS. 6-7, do not extend to the outer edge of the flange 30 and instead stop short a predetermined length therefrom at perimeter 36. This perimeter in one embodiment is within the inner circumference of the rim 12. Such a configuration removes the possibility of gaps for fluid or tissue to escape when a needle or other instrument is inserted through the opening of the tissue collection lid, which possibility exists in a flange in which the slits defining the flange members extend to the outermost perimeter of the tissue collection lid.
[0026] Referring to FIG. 4, the tissue collection lid 10 and specimen cup 20 are shown with a biopsy needle 40 being inserted through the aperture 18 in the tissue collection lid. Once the tissue port of the biopsy needle 40 is within the specimen cup 20, an ejection procedure can take place to release the tissue sample into the specimen cup. For instance, a sample port of the biopsy needle 40 is covered by a sheath or other component of the biopsy needle for insertion into the specimen cup; once the sample port has been completely inserted through the lid 10, the sample port is uncovered and the sample is ejected. The flange 30 prevents any fluid or tissue sample that splashes off the bottom or sides of the specimen cup 20 from escaping therefrom. FIG. 5 illustrates the biopsy needle being withdrawn from the specimen cup 20, following ejection of the tissue sample. Due to the configuration of the flange 30, as the needle 20 is withdrawn, one or more edges of the flange members 32, including the edges defining the aperture 18 and the side edges created by slits 34, scrape any remaining tissue sample from the port of the biopsy needle 40 for deposit within the specimen cup 2O1. Thus, no other surgical instruments are necessary for clearing the port of the biopsy needle 40, which is advantageous in terms of time and expenditure (e.g., cost for additional instruments).
[0027] FIG. 6 is a top perspective view of the flange 30 in isolation, showing the aperture 18 in the mid-point thereof, as well as the slits 34, which define the
individual flange members 32, extending radially from the aperture 18 to the perimeter 36. Although the aperture 18 is shown in the mid-point of flange 30 in this embodiment, other embodiments include an aperture that is off-center such that the flange members of a circular flange are of different length. In such embodiments, the flexural stiffness of the flange members may be different, meaning that the tissue collection lid provides stiffness variety among the flange members to provide the user several options for tissue extraction depending on need and/or preference. Further, the perimeter 36 can be sized to control the stiffness of the flanges and therefore the ease of probe insertion and/or tissue extraction. The thickness of the flange will also affect ease of insertion and tissue extraction and therefore can be sized according to user need and/or preference.
[0028] In one embodiment, the diameter of the flange 30 is approximately
1.580 inches, the diameter of the aperture 18 is approximately 0.148 inches, the diameter of the perimeter 36 is approximately 0.556 inches and the thickness of the flange is approximately 0.004 inches. FIG. 7 is a bottom view of the tissue collection lid 10, showing the underside of the flange 30 and rim 12. FIG. 8 is a cross-sectional side view of the tissue collection lid 10, where it can be seen that the flange 30 is embedded in the wall of the upper section 14 such that there is a space above the flange with respect to the top surface of the upper section 14 (i.e., the flange is not flush with the top surface of the upper section 14). Of course, depending on the thickness of the flange and/or the upper section, in other embodiments, there could be either more or less space above and/or below the flange. In one embodiment, the thickness of the upper section adjacent the flange 30 is approximately 0.125 inches, which is slightly less that the thickness of the upper section outer wall, which is approximately 0.155 inches; the thickness of the entire rim 12 (i.e., distance from top surface of the upper section 14 to the bottom edge of the lower section 16) is approximately 0.525 inches. Also, in one embodiment, the opening of the upper section 14 into which the flange 30 resides is approximately 1.380.
[0029] It is noted here that although FIGS. 6-9 illustrate a planar flange, there are other possibilities for the configuration of the flange 30. For example, in other embodiments contemplated herein, the flange members extend slightly out of plane
(e.g., the edges defining the opening in the middle point slightly upward or downward) to create a funnel profile in cross-section. Such a configuration may be further advantageous in providing a sealing and/or cleaning function as a needle is inserted through and withdrawn from the tissue collection lid.
[0030] FIG. 8 illustrates gripping barbs 17 extending outward from the lower section 16, FIG. 9 providing a detailed view thereof. This feature in tissue collection lid 10 ensures a fluid tight, friction fit connection between the tissue collection lid and the specimen cup into which it is placed. The gripping barbs 17 have an angled base that extends to a top surface that is perpendicular with respect to the side of the lower section 16 from which they extend so that when the tissue collection lid 10 is placed into specimen cup 20, the barbs 17 will bend slightly in an upward direction, ensuring a tight fit and preventing the lid from accidentally becoming dislodged from the specimen cup (positive force is required to remove the tissue collection lid from the specimen cup). In one embodiment, this angle is approximately 47° with respect to the top surface of the barb, although other angles would be equally suitable. It is also noted that the side of the lower section 16 is slightly angled from the bottom edge thereof to the first barb 17 (FIG. 9). In one embodiment, this angle is approximately 80° with respect to the top surface of the first barb 17. The gripping barbs as shown herein are representative of one feature for a tissue collection lid for keeping the tissue collection lid firmly secured within a specimen cup and providing a seal therewith. Thus, the gripping barbs, the interference fit between the lower section and open end of the container, elastomeric seal, glue, sealant and other suitable seals can be the means for forming a seal upon insertion of the lower section into the open end of the container.
[0031] This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described, hi addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the
variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.