Abstract:
The present disclosure provides an apparatus, and methods of using same, for collecting blood from an umbilical cord in a sterile environment that includes an umbilical cord retaining assembly and a blood collection assembly rotatably connected to the umbilical cord retaining assembly. A cord cutting blade, which is carried by the blood collection assembly, functions to cut the umbilical cord when the blood collection assembly is rotated relative to the umbilical cord retaining assembly. After the umbilical cord is cut, blood flows by force of gravity into the blood collection region of the blood collection assembly to which a blood collection bag can be interconnected.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC 
       [0003]    Not applicable 
       TECHNICAL FIELD 
       [0004]    The present disclosure relates generally to blood collection devices. More particularly, the present disclosure concerns an apparatus and method for collecting blood from an umbilical cord. 
       INTRODUCTION 
       [0005]    A sample of blood taken from a newborn baby&#39;s umbilical cord is a rich source of hematopoietic stem cells. Accordingly, cord blood has been used to treat a wide variety of diseases of the blood and immune system. Typically, cord blood is collected from the umbilical cord vein attached to the placenta after the umbilical cord has been detached from the newborn baby. Methods and devices for collection of cord blood are thus of interest. 
       SUMMARY 
       [0006]    By way of brief summary, the present disclosure provides a novel cord collection clamp for collecting blood from an umbilical cord in an aseptic environment that includes an umbilical cord retainer assembly and a blood collection assembly that is rotatably connected to the cord retainer assembly. The cord retainer assembly includes a channel through which the umbilical cord passes and is provided with an outlet that communicates with the collection chamber of the blood collection assembly. The blood collection assembly is rotatably connected to the retainer assembly and uniquely includes a cord cutting blade that is strategically positioned to move from a first position to a second cord cutting position upon rotation of the collection assembly relative to said retainer assembly, thereby cutting the umbilical cord. The present disclosure also provides methods of collecting cord blood, as well as collecting a sample of the umbilical cord, using a device as described herein. 
         [0007]    With the foregoing and mind, the present disclosure provides, in one embodiment, a cord collection clamp of the aforementioned character in which, during the umbilical cord cutting operation, the retainer assembly surrounds the umbilical cord and provides a biological seal. 
         [0008]    In a further embodiment, the present disclosure provides a cord collection clamp of the class described which is safer to operate than the prior cord cutting devices because the cord cutting blade of the apparatus is better separated from the operator making careless handling less likely to expose a cutting surface to the operator. 
         [0009]    In a further embodiment the present disclosure provides a cord collection clamp of the character described in which the retainer assembly includes a first segment overlaying a portion of the blood collection assembly, a second segment hingeably interconnected to the first segment and movable from a first position to a second position overlaying a portion of the blood collection assembly and a third segment hingeably interconnected to the second segment and movable from a first position to a second position overlaying a portion of said first segment and overlaying a portion of the blood collection assembly. 
         [0010]    In a further embodiment, the present disclosure provides a cord collection clamp of the type described in the preceding paragraph in which movement of the second segment of the retainer assembly into the second position functions to safely cover the cutting blade of the blood collection assembly in a manner to prevent accidental cutting of the user and further functions to lockably engage the blood collection assembly in a manner to prevent rotation of the assembly relative to the retainer assembly in a manner to expose the operator to the cord cutting blade. 
         [0011]    In a further embodiment, the present disclosure provides a cord collection clamp of the class described in the preceding paragraphs in which the blood collection assembly is provided with a locking member that is engaged by the second segment of the retainer assembly in a manner to block rotation of the blood collection assembly relative to the retainer assembly. 
         [0012]    In a further embodiment, the present disclosure provides a cord collection clamp as described in the preceding paragraph in which upon movement of the third segment of the retainer assembly into the second position, the third segment functions to act upon the locking member of the blood collection assembly in a manner to move the locking member out of engagement with the second segment of the retainer assembly so as to permit rotation of the blood collection assembly relative to the retainer assembly thereby permitting safe cutting of the umbilical cord. 
         [0013]    In a further embodiment, the present disclosure provides a cord collection clamp as described in the preceding paragraph in which continued rotation of the blood collection assembly relative to the retainer assembly will move the locking member into engagement with an aperture provided in the second segment of the retainer assembly so as to thereby block further rotation of the blood collection assembly relative to the retainer assembly thereby disabling the device. 
         [0014]    In a further embodiment, the present disclosure provides a cord collection clamp as described in the preceding paragraph in which, upon cutting of the umbilical cord, blood from the umbilical cord will flow freely by force of gravity into the collection chamber of the blood collection assembly. 
         [0015]    In a further embodiment, the present disclosure provides a cord collection clamp of the character described in the preceding paragraphs in which the blood collection chamber of the blood collection assembly is substantially closed to the external environment so that the blood from the umbilical cord is collected in a substantially aseptic environment. 
         [0016]    In a further embodiment, the present disclosure provides a cord collection clamp of the character described in the preceding paragraphs that is ergonomically superior to the prior cord cutting devices and one that is easier and less expensive to produce than the prior cord cutting devices. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is an exploded, front elevational view of one form of the cord collection clamp of the present disclosure. 
           [0018]      FIG. 2  is a front elevational view similar to  FIG. 1 , but showing the collection assembly, or lower portion of the cord collection clamp interconnected with the central, or first segment of the retainer assembly of the cord collection clamp. 
           [0019]      FIG. 3  is a front elevational view similar to  FIG. 2 , but showing the second segment of the retainer assembly of the cord collection clamp mated with the first segment of the retainer assembly. 
           [0020]      FIG. 4  is a front elevational view similar to  FIG. 3 , but showing the uncut umbilical cord entrained through the cord receiving channel of the retainer assembly of the device, showing the third segment of the retainer assembly of the cord collection clamp in dotted lines and illustrating the manner in which the third segment is rotated to mate with the first segment of the retainer assembly. 
           [0021]      FIG. 5  is a front elevational view similar to  FIG. 4 , but showing the third segment of the retainer assembly mated with the first segment of the retainer assembly. 
           [0022]      FIG. 6  is a diagrammatic view similar to  FIG. 5  showing the manner in which the retainer assembly is gripped by the user and the manner in which the collection assembly is gripped by the user prior to rotation of the collection assembly. 
           [0023]      FIG. 7  is a diagrammatic view similar to  FIG. 6 , but illustrating the manner in which the collection assembly is rotated relative to the retainer assembly to sever the umbilical cord. 
           [0024]      FIG. 2A  is a cross-sectional view of the first segment of the retainer assembly taken along lines  2 A- 2 A of  FIG. 2  and showing the second segment of the retainer assembly rotated toward a closed position and further illustrating one form of the locking mechanism of the present disclosure for interlocking the second segment with the first segment. 
           [0025]      FIG. 3A  is a cross-sectional view taken along lines  3 A- 3 A of  FIG. 3  illustrating the second segment of the retainer assembly interlocked with the first segment of the retainer assembly and also interlocked with the collection assembly so as to prevent rotation of the collection assembly relative to the retainer assembly. 
           [0026]      FIG. 4A  is a cross-sectional view taken along lines  4 A- 4 A of  FIG. 4  illustrating the second segment of the retainer assembly interlocked with the first segment and showing the third segment of the retainer assembly moved toward a closed position. 
           [0027]      FIG. 4B  is a cross-sectional view taken along lines  4 B- 4 B of  FIG. 6  showing the third segment of the retainer assembly moved into a closed position wherein it functions to act upon the locking protuberance of the collection assembly to permit rotation of the collection assembly relative to the retainer assembly. 
           [0028]      FIG. 4C  is a cross-sectional view taken along lines  4 C- 4 C of  FIG. 7  illustrating the rotation of the collector assembly of the present disclosure relative to the retainer assembly in a manner to cleanly cut the umbilical cord and also showing the relocking of the collector assembly against rotation relative to the retainer assembly to thereby disable the device from opening. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    Referring to the drawings and particularly to  FIGS. 1 and 2 , one form of the cord collection clamp of the present disclosure for collecting blood from an umbilical cord is there shown and generally designated by the numeral  14 . The device here comprises two inter-connectable assemblies, namely an upper, or umbilical cord retainer assembly  16  and a lower, or blood collection assembly  18  that is rotatably connected to the umbilical cord retainer assembly. 
         [0030]    The retainer assembly  16  uniquely comprises three hingeably interconnected segments, namely, a first, or central segment  20 , a second segment  22  and a third segment  24 . In a manner presently to be described, segments  20 ,  22  and  24  cooperate to form the device housing  25  ( FIG. 5 ). As best seen by referring to  FIG. 1  of the drawings, the first segment  20  has an upper portion  20   a , a lower portion  20   b  and includes an intermediate partition wall  20   c  that divides the upper and lower portions. As depicted in  FIG. 2  of the drawings, in using the device of the present disclosure, the upper portion  18   a  of the collection assembly seats within the lower portion  20   b  of first segment  20 . 
         [0031]    As illustrated in  FIG. 1 , second segment  22  of the retaining assembly is connected to first segment  20  by a living hinge  26  and, in a manner presently to be described, is movable from a first position shown in  FIG. 2  of the drawings to a second position shown in  FIG. 3  wherein it overlays the upper portion  18   a  of the collection assembly  18  and interlocks with first segment  20  by means of an interlocking mechanism  28  of conventional design the character of which is illustrated in  FIG. 2A  of the drawings. As indicated in  FIG. 3  interlocking mechanism  28  functions to interlock together first and second segments  20  and  22  when second segment  22  is in the second position. 
         [0032]    Similarly, third segment  24  of the retaining assembly is connected to first segment  20  by a living hinge  30  and, in a manner presently to be described, is movable from a first position shown in  FIG. 3  of the drawings to a second position shown in  FIG. 5  wherein it overlays a portion of first segment  20  and interlocks with the first segment by means of a conventional locking mechanism  32  the character of which is illustrated in  FIG. 4A  of the drawings. 
         [0033]    As best seen in  FIG. 1 , collection assembly  18  includes a collar  18   b  that is disposed intermediate upper portion  18   a  and lower catch reservoir portion  18   c . The upper portion  18   a  of the collection assembly is provided with a generally U-shaped, umbilical cord receiving opening  34 . Mounted proximate opening  34  is the important umbilical cord cutting blade  36  of the present disclosure. The upper portion  18   a  of the collection assembly also includes a locking assembly  38 , which in a manner presently be described, functions to prevent accidental rotation of the collection assembly  18  relative to the retainer assembly  16 . 
         [0034]    It is to be noted that upon closing second segment  22 , a generally U-shaped opening  40  formed in second segment  22  aligns with opening  34  formed in the collection assembly to permit passage of the umbilical cord. It is also important to note that upon closing second segment  22 , the cutting edge of cutting blade  36  is covered by the blade covering protective portion  22   a  of second segment  22  (see  FIG. 4 ). This important blade covering protective portion of the second segment, which is disposed proximate opening  40 , functions to effectively protect the operator from being accidentally cut by the blade during the positioning of the umbilical cord within the cord collection clamp (see also  FIGS. 2A and 3A ). 
         [0035]    As illustrated in  FIG. 1  of the drawings, center segment  20  of the retainer assembly  16  is provided with an inwardly extending shoulder  42 . Similarly, second segment  22  is provided with an inwardly extending shoulder  44  that mates with shoulder  42  when the second segment is moved into the closed position shown in  FIG. 3  of the drawings. When the collection assembly  18  is mated with the retaining assembly in the manner shown in  FIG. 2  of the drawings and when the second segment  22  is in the closed position, collar  18   b  the of the collection assembly engages shoulders  42  and  44  and functions as a removal preventing assembly that prevents removal of the collection assembly from the retainer assembly. Additionally, in a manner next to be discussed and as illustrated in  FIGS. 2A and 3A  of the drawings, when the second segment  22  is moved into the closed position, collection assembly  18  will be locked against rotation relative to the retainer assembly  16 . This anti-rotation locking feature is accomplished by the previously identified locking assembly  38  which comprises a yieldably deformable locking finger  38   a  and a locking protuberance  38   b  that is formed proximate the extremity of the locking finger. As the second segment moves toward the closed position and as indicated by the arrow  45  in  FIG. 2A , locking protuberance  38   b  will be received within a locking protuberance receiving aperture  48  formed in the second segment. With the locking protuberance positioned within locking protuberance receiving aperture  48  in the manner shown in  FIG. 3A , the collection assembly  18  will be locked against rotation relative to the retainer assembly. Additionally, second segment  22  will be interlocked with segment  20  as the male portion  28   a  of interlocking mechanism  28  seats within female portion  28   b.    
         [0036]    With the cord collection clamp in the configuration illustrated in  FIGS. 3 and 3A , wherein the collector assembly  18  is locked against removal from the retainer assembly, wherein a portion of the second segment  22  protectively covers the cutting blade  36  and wherein the collector assembly  18  is locked against rotation relative to the retainer assembly, the umbilical cord (shown by the dotted lines in  FIG. 3A ) can safely be positioned within the device in preparation of the cord cutting operation. With the conventional cord clamp CC in position so as to stop umbilical cord blood flow, the umbilical cord can be entrained through the online openings  34  and  40  in the manner illustrated in  FIG. 4 . As the umbilical cord is so positioned, the cord will be seated within a channel  52  that is formed within a foam insert  54  that is mounted in the upper portion of first segment  20 . This done, the third segment  24  of the retainer assembly is moved from the position shown in the dotted lines in  FIG. 4  into the closed position shown in  FIG. 5 . With the third segment in the closed position, the umbilical cord is closely received within a channel  56  that is formed within a foam insert  58  that is mounted in the upper portion of third segment  24 . As illustrated in the drawings, foam insert  54  is supported within first segment  20  by the previously identified, inwardly extending wall  20   c , while foam insert  58  is supported within third segment  24  by an intermediate, inwardly extending wall  59 . It is to be appreciated that with the construction thus described, the generally U-shaped cord receiving openings  34  and  40  formed in the collection assembly and in the cord retaining assembly respectfully, cooperate with channels  52  and  56  to form the umbilical cord retaining channel of the present disclosure which functions to support the umbilical cord during the cutting operation. However, in this regard, it is to be appreciated that the umbilical cord cutting operation cannot be accomplished until the yieldably deformable locking finger of the locking assembly  38  is acted upon by the release assembly of the present disclosure in a manner to permit rotation of the collection assembly relative to the cord retaining assembly. It is to be appreciated that movement of the third segment of the retainer assembly into the closed position shown in  FIG. 5  not only clamps the umbilical cord in position, but also actuates the release assembly of the present disclosure in a manner next to be described. More particularly, as illustrated in  FIGS. 4A and 4B  of the drawings, as the third segment  24  moves into the closed position as indicated by the arrow  61  in  FIG. 4A , a release protuberance  64  provided on the inner wall of third segment, which forms a part of the release assembly of the present disclosure, moves toward protuberance  38   b  of assembly  38  in the direction of the arrow  65 . When the third segment  24  reaches the closed position shown in  FIG. 4B , the yieldably deformable locking finger along with protuberance  38   b  will have been moved inwardly by protuberance  64  and clear of aperture  48  formed in second segment  22  so as to no longer block rotation of the collection assembly. Additionally, third segment  24  will be interlocked with segment  20  as the locking tab  32   a  of interlocking mechanism  32  seats within tab receiving portion  32   b . With the third segment  24  in the closed position, a protective sleeve  68  formed on third segment  24  covers the generally U-shaped opening  40  that forms a part of the umbilical cord channel and thereby functions to further protect the operator from accidental cutting by the cutting blade. 
         [0037]    As illustrated in  FIGS. 6 and 7  of the drawings, in accomplishing the severing operation, the retainer assembly is gripped with one hand of the user and the collection assembly is gripped by the other hand so that the collection assembly can be rotated in the manner indicated by the arrow  69  of  FIG. 7 . As the collection assembly is rotated, the cutting blade will traverse the portion of the cord retaining channel defined by the cord receiving openings  34  and  40  thereby severing the umbilical cord. More particularly, as illustrated in  FIGS. 4B and 4C , as the collection assembly is rotated, the cutting blade  36  will traverse the cord receiving opening  34  in said second segment of the retainer assembly thereby cleanly severing the umbilical cord in the manner shown in  FIG. 4C . 
         [0038]    Referring particularly to  FIG. 4C  of the drawings, it is to be noted that as the collection assembly  18  is rotated in the direction of the arrow of  FIG. 4C , the outwardly extending protuberance  38   b  formed on the deformable locking finger  38   a  will move into alignment with a disabling aperture  70 , which forms a part of the disabling assembly of the present disclosure, and will be lockably received there within thereby disabling the cord collection clamp and preventing further rotation of the collection assembly relative to the retaining assembly. 
         [0039]    After the umbilical cord is severed, blood will flow from the cord via gravity into the blood collection region  18   c  of the collection assembly. Since the blood collection assembly is at this point substantially closed to the external environment, the blood is therefore collected in a substantially aseptic environment. In practice, the lower portion of the blood collection assembly acts as a funnel to funnel the blood toward an outlet port  18   p  to which an external collection bag (not shown) can be interconnected. 
         [0040]    Having now described the present disclosure in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the present disclosure as set forth in the following claims.