Abstract:
Apparatus and method for freezing biopsy material. The apparatus includes a container that includes an inner wall and an outer wall defining a space therebeween for receiving a material adapted to withstand a temperature below −20° F. The apparatus further includes a cooling insulating medium that is disposed between the inner wall and the outer wall, a biopsy holding section that is disposed in the cavity and that is configured for holding the biopsy material, and a brine solution that is disposed in the cavity such that the biopsy material held in the biopsy holding section is completed submerged in the brine solution.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates to a method and device that uses a brine solution for freezing biopsy material extracted from a patient. 
       BACKGROUND OF THE INVENTION 
       [0002]    During the course of medical evaluation, or during other medical procedures, samples of body tissue from a patient are extracted and retained for biopsy. A biopsy is a medical test involving the removal of cells or a sample of tissue for examination. The tissue is generally examined under a microscope by a pathologist and can also be analyzed chemically, for example, using PCR, mass spectroscopy, nucleic acid array, immunological or chromatography techniques. When a tissue sample is extracted, it must be immediately preserved to retain the integrity of the sample as it is transported to a laboratory for testing and analysis. Chemical and low temperature preservations are routinely attempted. 
         [0003]    Typical methods for immediately freezing the biopsy sample involve complex and expensive devices, which also require the use and interaction with hazardous and dangerous cooling materials, such as liquid nitrogen, dry ice and/or combinations of flammable solvents. Moreover, such equipment is typically powered by electricity, receiving operating power from line voltage in an operating room. Such equipment is not desirable as it causes unwanted clutter and must also comply with strict standards governing the use of electrical equipment in operating rooms. 
         [0004]    Accordingly an apparatus and method are desired for allowing the freezing of biopsy tissue in a convenient and efficient manner while providing transport of the biopsy tissue and without causing undue clutter to an operating room. 
       SUMMARY 
       [0005]    In one aspect, the invention involves an apparatus for freezing biopsy material. The apparatus includes a container defining a cavity and having a bottom surface, and an inner wall and an outer wall. The outer wall is spaced from the inner wall and the space includes a material that is adapted to withstand a temperature below −20° F. The apparatus further includes a brine solution disposed in the cavity, a cooling medium disposed between the inner wall and the outer wall for maintaining the brine solution at a temperature no higher than −20° F., and a biopsy holding section disposed in the cavity and configured for holding the biopsy material above the bottom surface and below an upper surface of the brine solution such that the biopsy material is completely submerged in the brine solution 
         [0006]    In one embodiment, the material of the inner wall and the outer wall include stainless steel or aluminum. In another embodiment, the biopsy holding section includes a mesh section and mesh section holding members. In still another embodiment, the mesh section and the mesh section holding members include stainless steel or aluminum. In yet another embodiment, the mesh section holding members are coupled to the mesh section and the inner wall, and suspend the mesh section in the cavity. In other embodiments, the cooling medium comprises Cold Ice −10° F. “Y” Formula Gel Ice. In still another embodiments, the apparatus includes an insulation material disposed on the outer wall, handles coupled to the outer wall, and a removable double walled cover. In another embodiment, the cover includes an inner wall, an outer wall, a cooling medium disposed between the inner wall and the outer wall, a handle, and releasably latches or couples to the container. In yet another embodiment, the cover includes a brine solution circulating mechanism configured to circulate the brine solution around the biopsy material disposed in the cavity. In one embodiment, the circulating mechanism includes one or more stirring members, a drive mechanism for driving the stirring members, and a power supply for supplying power to the drive mechanism. In another embodiment, the circulating mechanism includes at least one manually actuated stirring member. In still another embodiment, the one or more stirring members, a drive mechanism for driving the stirring members, and a power supply are replaceable with a manually actuated stirring member. In yet another embodiment, the power supply includes a power switch for enabling or disabling power to the drive mechanism. In another embodiment, the biopsy sample is stored in an aluminum foil packet or a stainless steel tube. In another embodiment, the brine solution includes at least about 0.005% by weight of cruciferous oil, about 0.005% to 0.018% by weight of cruciferous oil, propylene glycol and deionized water, or calcium chloride. In another embodiment, the brine solution includes about 0.01% by weight of rapeseed oil, about 43.18% by weight of water, about 44.06% by weight of propylene glycol, and about 12.75% by weight of calcium chloride. 
         [0007]    According to another aspect, the invention involves a method of freezing biopsy material in an operating room. The method includes providing an apparatus as described above, disposing the container in a freezer to freeze the cooling medium, filling the container with the brine solution having a temperature no higher than −20° F., and disposing the biopsy material in the container such that the biopsy material is completely submerged in the brine solution. 
         [0008]    According to yet another aspect, the invention involves an apparatus for freezing biopsy material. The apparatus includes a container defining a cavity and having a bottom surface, an inner wall and an outer wall. The outer wall is spaced from the inner wall. The inner wall and the outer wall include a material adapted to withstand a temperature below −20° F. The apparatus further includes a brine solution disposed in the cavity, a cooling medium disposed between the inner wall and the outer wall maintaining the brine solution at a temperature no higher than −20° F., a removable double walled cover configured to seal the cavity, and a biopsy holding section. The biopsy holding section is either coupled to a side of the cover proximate the brine solution, coupled to a stirring member that is coupled to the cover, or acts/functions as the stirring member coupled to the cover. The biopsy holding section is positioned for immersion in the brine solution when the cover is disposed on the container in sealing engagement therewith. 
         [0009]    In one embodiment, the biopsy holding section acting as the stirring member coupled to the cover includes a bracket and an aluminum foil packet holding the biopsy material. The bracket holds the aluminum foil packet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    In the drawings, like reference characters refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. 
           [0011]      FIG. 1  is an illustrative cross-sectional diagram of a container which uses a cooled brine solution for preserving a biopsy sample while the sample is transported from an operating or biopsy room to a testing laboratory in accordance with an embodiment of the invention. 
           [0012]      FIG. 2A  is an illustrative cross-sectional diagram of the container including a cover for the container of  FIG. 1 . 
           [0013]      FIG. 2B  is an illustrative cross-sectional diagram of a cover including a biopsy sample holding section coupled to the underside of the cover. 
           [0014]      FIG. 3A  is an illustrative cross-sectional diagram of the container including a cover with an automatic circulating mechanism. 
           [0015]      FIG. 3B  is an illustrative cross-sectional diagram of the container including a cover with an automatic circulating mechanism and a biopsy sample attached to one of the stirring members. 
           [0016]      FIG. 3C  is an illustrative cross-sectional diagram of the container including a cover with a circulating mechanism with an aluminum foil packet holding a biopsy sample acting as a stirring member 
           [0017]      FIG. 3D  is an illustrative cross-sectional diagram of the container including a cover with a manual circulating mechanism. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    Referring to  FIG. 1 , a container  102  is formed of a material that is capable of withstanding temperatures below −20° F., such as stainless steel or aluminum, or other medical grade material known in the art. The container  102  is open at one end to define a cavity  104  for holding a reservoir or “bath” of a brine solution  130  and a biopsy sample  132 . The container  102  includes an inner wall  106  spaced from an outer wall  108  to define an inner area therebetween for receiving a cooling material or medium  112 , such as a gel. An example of a suitable cooling medium is Cold Ice −10° F. “Y” Formula Gel Ice from Cold Ice, Inc. The cooling medium  112  functions to insulate the cavity  104  from the ambient room temperature and maintain the brine solution  130  disposed therein at a temperature no higher than −20° F. 
         [0019]    The container  102  further includes a biopsy sample holding section  114  for holding the biopsy sample  132  stationary and suspended below a surface of the brine solution  130 , such as in the center of the cavity  104 . The biopsy sample holding section  114 , in one embodiment, includes a stainless steel or aluminum screen or mesh section  116 , such as a basket, and mesh section holding members  118  which may be in the form of arms or rods which connect the basket  116  to the container  102 , and suspend the basket  116  in the cavity  104 . The biopsy sample holding section  114  allows the brine solution  130  to contact all sides of the biopsy sample  132  when the biopsy sample is in the basket  116  and immersed in the brine solution. 
         [0020]    In one embodiment, the biopsy sample, after extraction from the patient using extraction methods known to those skilled in the art, is deposited in an aluminum foil packet, which provides exposure of a greater surface area of the biopsy sample for rapid freezing. In another embodiment, the biopsy sample is left in a stainless steel tube used with a biopsy extraction needle. The stainless steel tube has an inner diameter that is greater than the biopsy extraction needle to facilitate easy removal of the frozen biopsy sample. 
         [0021]    In one embodiment, the aluminum foil packet or stainless steel tube is placed in (and later removed from) the biopsy sample holding section  114  using forceps or tongs or similar medical instrument. 
         [0022]    In another embodiment, the outer wall  108  is covered with an insulation material  120  that helps to insulate the interior area  110  and the cavity  104  from the ambient room temperature. The material  120  also serves to prevent a user from direct contact with the cold outer wall  108 . 
         [0023]    In still another embodiment, the container  102  includes handles  122  which further function to protect a user&#39;s hands from the freezing effects of the brine solution  130  and which allows the container to be transferred to a testing laboratory where the biopsy sample can be removed for testing. In addition to handles, wheels may be provided to assist in container transport. 
         [0024]    Referring to  FIG. 2A , in another embodiment, the container  102  includes a removable double walled cover  202  which includes an inner wall  206  and an outer wall  208  with a cooling medium  212  such as a gel or other material disposed therebetween. In a preferred embodiment medium  212  is the same as medium  112 . The cover  202  also includes a handle  210  for easy manipulation of the cover. In still another embodiment, the cover  202  is hingedly connected at one end to the container and includes latches at an opposite end to allow the container to be selectively opened or closed. The latches secure the cover to the container in the closed position and allow for containment of the container contents during container transport. 
         [0025]    In another embodiment, as shown in  FIG. 2B , the cover includes a mesh section  216  removably attached to the underside of the cover  202 . In this embodiment, after the biopsy sample is obtained, the biopsy sample is placed in the mesh section  216  and the cover  202  is placed over the cavity  104  containing the brine solution  130 . After the cover  202  is in place, the mesh section  216  and the biopsy sample contained therein, are immersed in the brine solution  130 . 
         [0026]    Referring to  FIG. 3A , in still another embodiment the cover  202  includes a brine solution circulating mechanism  302 . The circulating mechanism  302  includes one or more stirring members  304 , a drive mechanism  306  for driving the stirring members  304 , and a power supply  308  for supplying power to the drive mechanism  306 . The power supply  308  (e.g., batteries) includes a power switch  310  for enabling or disabling power to the drive mechanism  306 . The circulation mechanism  302  functions to circulate the brine solution  130  around the biopsy sample suspended in the cavity  104  to provide a uniform temperature of the brine. The power switch  310  can be manually operated or can be in the form of a position switch mounted on one of the cover or container and activated when the cover is in its closed position to operate the circulation mechanism. 
         [0027]    Referring to  FIG. 3B , in yet another embodiment the biopsy sample is shown contained in an aluminum foil packet  316  which is attached to one of the stirring members  304  by a bracket  318 . As the stirring member  304  moves, the biopsy sample is moved through the brine solution  130  thereby allowing the brine solution  130  to circulate around the biopsy sample. It will be appreciated that in the embodiment of  FIG. 3B  the biopsy holding section  114  will not be required and, for at least this reason, is desired to be detachable and removable from the container. 
         [0028]    Referring to  FIG. 3C , in another embodiment, a biopsy holding section  336  acting as a stirring member  338  coupled to the cover  202  is shown. The biopsy holding section  336  includes an arm  334 , a bracket  332 , and an aluminum foil packet  330 , which holds a biopsy sample. The bracket  332  holds the aluminum foil packet  330  at the foil packet&#39;s edges. The bracket  332  is also coupled to the arm  334 . As the stirring member  338  moves in the brine solution  130 , the aluminum foil packet  330  holding the biopsy sample is also moved through the brine solution, thereby allowing the brine solution to circulate around the aluminum foil packet  330  holding the biopsy sample. 
         [0029]    Referring to  FIG. 3D , in another embodiment the cover  202  includes a manual brine solution circulating mechanism  320 . The circulating mechanism  320  includes stirring members  304 , a gear assembly  314 , and an actuator such as a handle  312 . In operation, after the cover  202  closes the container  102 , a lab technician activates the actuator  312  which in turn engages gears in the gear assembly  314 , which cause rotation of the stirring members  304 . As above, the circulation mechanism  320  functions to circulate the brine solution  130  around the biopsy sample suspended in the cavity  104  to provide a uniform temperature of the brine solution. 
         [0030]    This manually actuated embodiment is particularly useful in an operating room because the brine solution could be circulated without requiring that the circulating mechanism meet the strict requirements governing electrical devices in an operating room environment because of the presence of volatile gases. 
         [0031]    In use, the container  102  with cover  202  are disposed in a freezer to cool the gel  112 ,  212 . After cooling, the brine solution  130 , which has been previously cooled to a temperature of −20° F. or below, is disposed in the cavity  104  and the cover is closed. The gel  112 ,  212  functions to keep the brine solution at a temperature no higher than −20° F. 
         [0032]    It is preferred that the cooled brine-containing container be located in or proximate to an operating room for surgery, or a room where biopsies are performed. After a biopsy sample  132  has been extracted from a patient, and with the cover  202  in an opened position, the biopsy sample  132  is submerged in the brine solution  132  in the cavity  104  and placed in the biopsy sample holding section  114 , for example, by placing the biopsy material (i.e., the foil packet or the stainless steel tube) in the basket and placing the basket  116  on the holding section  114 . In another embodiment, the basket  116  is fixed to, or on, the holding section  114  and the biopsy sample in the foil packet or the stainless steel tube is placed in the basket  116  using forceps or tongs. Alternately, and a shown in  FIG. 3B , the foil packets are mounted directly to the stirring members  304 . 
         [0033]    The cover  202  is then closed to cover the brine solution, and the circulating mechanism  302  is activated, whereupon the stirring members  304  circulate the brine solution  130  in the container and, as a result, around the biopsy sample  132 . Because the container  102  is intended to be portable so that it can be transported, for example, between an operating room and a testing laboratory, it is preferred that if the power supply is used, it operates on battery power. Alternatively, the manual brine circulating mechanism described above can be used. Thereafter, the container  102  may be used to transport the biopsy sample  132  to a laboratory so that the biopsy sample  132  can undergo testing and analysis. 
         [0034]    The brine composition can be any composition suitable for freezing an item, such as any of the brine solutions disclosed in U.S. Pat. Nos. 4,601,909; 4,654,217; 4,657,768; 4,689,963; 4,743,343; 4,840,034; 4,840,035; 5,001,047; and 6,248,381, the contents of which are incorporated by reference. 
         [0035]    Preferably, the brine comprises at least about 0.005% by weight of cruciferous oil. More preferably, about 0.005% to 0.018% by weight of cruciferous oil such as rapeseed oil may be used. Alternatively, the amount of cruciferous oil may be selected such that a maximum amount of the oil is dissolved in the brine. 
         [0036]    The brine composition preferably comprises propylene glycol and water. It is also preferable that the brine composition contains calcium chloride. The water used in the composition is preferably deionized before being added into the brine composition. 
         [0037]    In accordance with one embodiment of the present invention, the brine composition in a desired balance comprises about 0.01% by weight of rapeseed oil, about 43.18% by weight of water, about 44.06% by weight of propylene glycol, and about 12.75% by weight of calcium chloride. 
         [0038]    In accordance with one embodiment of the present invention, the brine may be cooled to a predetermined temperature of below about −20° F., preferably −30° F. to about −43° F., and more preferably about −38° F. to −40° F. 
         [0039]    Variations, modifications, and other implementations of what is described herein may occur to those of ordinary skill in the art without departing from the spirit and scope of the invention. Accordingly, the invention is not to be defined only by the preceding illustrative description.