Abstract:
A surgical fluid collection apparatus includes a housing member defining an internal chamber for collection of body fluids and a holder member releasably couplable to the housing member. The holder member includes an internal penetrating member defining an internal conduit in fluid communication with a fluid outlet of the housing member when the holder member is coupled to the housing member to permit passage of the body fluids therethrough. A collection member is positionable with respect to the holder member to receive the body fluids passing through the internal conduit of the internal penetrating member.

Description:
BACKGROUND 
   1. Technical Field 
   The present disclosure generally relates to fluid collection apparatus, and more particularly, to an apparatus that facilitates fluid collection from an umbilical cord while preventing hazardous exposure to blood and body fluids collected. 
   2. Background of the Related Art 
   Body fluids, such as blood, urine, etc., can be collected during various medical procedures for analysis. For example, fluid and blood samples are typically collected from an umbilical cord of a newborn infant to ascertain blood type and Rh factor. Collection of umbilical cord blood is also beneficial due to its considerable curative value, e.g., use in bone marrow replacement procedures for treatment of cancer and immuno-deficiency disorders. Further, fetal blood has important commercial and therapeutic use in medical fields, such as, tissue culture, stem cell collection, pharmacology and biological research. 
   Several methods for umbilical cord blood sampling are known. One method includes holding a severed free end of an umbilical cord, still attached to a placenta, over a test tube or container. Blood is drained from the placenta into the test tube or container by milking the umbilical cord. A typical sample requires about 5 cc. This procedure has several disadvantages in that it is awkward to perform, difficult to control the sterility of the collected cord blood and may hazardously expose medical personnel to cord blood due to splattering, etc. 
   In another method, blood is drawn from the umbilical cord vein via a large gauge needle and syringe. This procedure is also awkward to perform and may hazardously expose medical personnel to potential needle sticks. More recently, an umbilical cord segment is clamped on two ends and moved to a collection device or container where the cord blood is drained by removing the clamps from either or both ends. Ultimately, the cord blood must be transferred to a storage container, such as a test tube, to prevent contamination of the blood and minimize hazardous exposure to health care workers. These funnel type collection devices require larger apertures that interface with non-standard wide-mouthed test tubes because they rely on gravity to cause the blood to flow. Other cord blood collection devices include large containers to hold the entire cord segment. The containers are sealed so that vacuum pressure can be used to cause blood to flow through a smaller aperture or needle. Needle type interfaces, however, must include shielding to protect medical personnel. The necessary shielding adds more bulk to the collection device. 
   The above devices disadvantageously expose medical personnel to accidental needle sticks and potentially hazardous body fluids. Needlesticks can, for example, occur during manipulation of a collection device including, assembly, dis-assembly or insertion into a blood vessel of the umbilical cord. Hazards such as, for example, needlesticks, splattering, etc. can present dangerous exposure to fluids contaminated with bacterial diseases, and potentially fatal viral infections such as AIDS, Hepatitis B and C, etc. 
   Attempts have been made to overcome the disadvantages of the prior art and prevent hazardous exposure to blood and body fluids. Some designs employ a needle hood for a needle container which sealingly engages an evacuated tube. See, e.g., U.S. Pat. Nos. 5,915,384 and 5,342,328. Designs of this type, however, still involve the use of a container with a needle and may not adequately prevent hazardous exposure to blood and body fluids. Still other designs employ complicated valve connections between a container and a syringe for receiving collected cord blood. These prior designs, however, may not safely transfer fluid due to their complexity and number of parts. Complex structure can result in high manufacturing costs. Further, these configurations are not easily adapted to existing medical components. 
   Consequently, there remains a need to provide a more satisfactory solution for fluid collection apparatus by overcoming the disadvantages and drawbacks of the prior art. Therefore, it would be desirable to provide a fluid collection apparatus for collection of umbilical cord fluid which prevents hazardous exposure to blood and body fluids and is adaptable to existing medical components. Such a fluid collection apparatus should have reduced complexity to increase reliability and improve fluid collection. It would be highly desirable for the fluid collection apparatus to employ luer connections thereby minimizing the potential for inadvertent needle stick. 
   SUMMARY 
   Accordingly, the present disclosure addresses a need for a fluid collection apparatus which protects practitioners, supporting medical personnel and patients from hazardous exposure during umbilical cord fluid collection. The present disclosure resolves related disadvantages and drawbacks experienced in the prior art. More specifically, the apparatus and method of the present disclosure constitute an important advance in the art of fluid collection by providing an apparatus with reduced complexity and fewer needle interfaces. This structure advantageously improves safety and reliability while lowering manufacturing cost. Moreover, the apparatus does not require needle shields, etc. thereby reducing bulk. Desirably, the fluid collection apparatus employs luer connectors to avoid needle use and increase safety. 
   In one particular embodiment, in accordance with the principles of the present disclosure, a fluid collection apparatus is provided. The fluid collection apparatus includes a housing configured for receipt of fluid and has a first surface which defines a needleless first mating portion. A holder has a first end and a second end configured to receive an evacuated tube. The first end defines a second mating portion on an outer surface thereof which is in fluid communication with the evacuated tube. The first mating portion sealingly engages the second mating portion to establish fluid communication therebetween. 
   The housing may have a cylindrical body portion configured and dimensioned to support at least a portion of an umbilical cord. The first surface of the housing can have a funnel configuration. The first mating portion and the second mating portion may alternatively include a male connector and a female connector. Desirably, the first mating portion engages the second mating portion in a slip interference fit. 
   In another embodiment, the first mating portion has a locking surface that engages the second mating portion to lock the housing with the holder. The housing can be releasably locked with the holder. The locking surface may have a threaded portion that receives the second mating portion. In yet another embodiment, the first end of the holder includes a needle hub supporting a needle cannula in fluid communication with the second mating portion and extending away from the first mating portion. The needle cannula may engage the evacuated tube to establish fluid communication between the first mating portion and the evacuated tube. 
   In an alternate embodiment, an umbilical cord fluid collection apparatus includes a cylindrical housing defining a cavity for receipt of at least a portion of an umbilical cord. The housing has a funnel surface which defines a male luer connector. A holder has a first end and a second end configured to receive an evacuated tube. The first end defines a female luer connector on an outer surface thereof in fluid communication with an inner surface of the first end. The inner surface is in fluid communication with the evacuated tube. The male luer connector sealingly engages the female luer connector to establish fluid communication between the male luer connector and the evacuated tube. The configuration of the male luer connector of the housing advantageously facilitates adaptability to pre-existing holders having female luer connectors. The funnel surface may have a locking surface that engages the first end to lock the housing with the holder. The locking surface may be disposed about the male luer connector and includes a threaded portion that receives the first end of the holder. The inner surface of the first end can include a needle hub supporting a needle cannula in fluid communication with the female luer connector and extending away from the male luer connector. The needle cannula may engage the evacuated tube to establish fluid communication between the male luer connector and the evacuated tube. 
   A method for collecting umbilical cord fluid is provided including the steps of: providing a fluid collection apparatus, similar to those described, attaching a first mating portion to a second mating portion to form a non-puncturing seal therebetween; disposing umbilical cord fluid in a housing; inserting an evacuated tube with a holder to establish fluid communication between the second mating portion and the evacuated tube such that umbilical cord fluid is collected in the evacuated tube. The step of providing may include an inner surface of a first end of the holder having a needle cannula extending away from the first mating portion such that the step of inserting includes puncturing the evacuated tube with the needle cannula to establish fluid communication between the second mating portion and the evacuated tube. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The objects and features of the present disclosure are set forth with particularity in the appended claims. The present disclosure, as to its organization and manner of operation, together with further objectives and advantages may be understood by reference to the following description, taken in connection with the accompanying drawings, in which: 
       FIG. 1  is an enlarged side view, in part cross section, of one particular embodiment of a housing of a fluid collection apparatus, in accordance with the principles of the present disclosure; 
       FIG. 2  is a front plan view of the housing shown in  FIG. 1 ; 
       FIG. 3  is a side perspective view of the housing shown in  FIG. 1 ; 
       FIG. 4  is a side perspective view of the housing shown in  FIG. 3  and a holder of the fluid collection apparatus; 
       FIG. 5  is a side perspective view of the housing and the holder shown in  FIG. 4 , assembled, and an evacuation tube of the fluid collection apparatus; 
       FIG. 6  is a side perspective view of the assembled fluid collection apparatus shown in  FIG. 5  collecting fluid from an umbilical cord; and 
       FIG. 7  is a side perspective view of the fluid collection apparatus shown in  FIG. 5  upon collection of fluid. 
   

   DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
   The exemplary embodiments of the fluid collection apparatus and methods of operation disclosed are discussed in terms of a fluid collecting device, and more particularly in terms of an umbilical cord blood collection apparatus that mates its constituent parts with a fluid collection holder that prevents hazardous exposure to blood and body fluids including, for example, inadvertent needle stick. It is contemplated that a housing of the fluid collection apparatus uses a needless mating connection to increase safety during use including storage, transport, fluid collection, subsequent thereto, etc. It is envisioned that the present disclosure, however, finds application to a wide variety of fluid collection procedures relating to analysis, sampling, diagnosis, treatment, etc. It is further envisioned that the present disclosure may be employed for collection of various body fluids including those relating to phlebotomy, digestive, intestinal, urinary, veterinary, etc. It is contemplated that the components of the fluid collection apparatus may be utilized with other medical application devices including phlebotomy devices, catheters, catheter introducers, guide wire introducers, and those employed during procedures relating to spinal and epidural, biopsy, aphaeresis, dialysis, etc. 
   In the discussion that follows, the term “proximal” refers to a portion of a structure that is closer to a practitioner, and the term “distal” refers to a portion that is further from the practitioner. As used herein, the term “subject” refers to a patient that has blood and/or fluid collected therefrom using a fluid collection apparatus. According to the present disclosure, the term practitioner refers to an individual performing fluid collection, installing, assembling or removing the fluid collection apparatus and may include support personnel. 
   The following discussion includes a description of the fluid collection apparatus, followed by a description of the method of operating the fluid collection apparatus in accordance with the present disclosure. Reference will now be made in detail to the exemplary embodiments of the disclosure, which are illustrated in the accompanying figures. 
   Turning now to the figures, wherein like components are designated by like reference numerals throughout the several views. Referring initially to  FIGS. 1 and 2 , there is illustrated a cylindrical housing  12  of an umbilical cord fluid collection apparatus  10  ( FIG. 5 ), constructed in accordance with the principles of the present disclosure. Fluid collection apparatus  10  is advantageously configured to prevent hazardous exposure to blood and body fluids by providing a needleless sealing engagement between housing  12  and the components of fluid collection apparatus  10 , as will be discussed. The design of fluid collection apparatus  10  provides improved reliability and reduces associated manufacturing costs. 
   Housing  12  is configured for receipt of a fluid, such as, for example, umbilical cord blood  13  ( FIG. 6 ) and defines a cavity  14  for receipt of at least a portion of an umbilical cord  16  ( FIG. 5 ). Cavity  14  is cylindrical, however, it is contemplated that the cavity may have other geometric configurations, such as, for example, rectangular, etc., according to the particular requirements of a medical application. Housing  12  has a first surface, such as, for example, a funnel  18 . Funnel  18  is configured to direct cord fluid accumulation toward a central section thereof and consequently in position for collection into an evacuated tube  28  ( FIG. 5 ). It is contemplated that gravity and/or a vacuum force from evacuated tube  28  cooperates with funnel  18  to draw fluid therethrough. It is envisioned that the first surface of housing  12  may have other orientations such as, for example, planar, etc. 
   Funnel  18  defines a first mating portion, such as, for example, a male luer connector  20  to facilitate a needless sealing engagement with a fluid collection holder  22 , as shown in  FIG. 4 , and discussed below. Holder  22  has first end  24  that longitudinally extends to a second end  26 . Holder  22  is substantially cylindrical and defines a tubular cavity  27 . Second end  26  is configured to receive evacuated tube  28  for disposal within cavity  27 . It is contemplated that cavity  27  may various geometric cross-sections, such as, for example, circular, rectangular, etc. according to the requirements of a particular medical application. 
   First end  24  defines a second mating portion, such as, for example, a female luer connector  30  on outer surface  32  thereof. Female luer connector  30  engages male luer connector  20 , as will be discussed, to form a needleless seal and facilitate transfer of cord blood  13  to evacuated tube  28 . Female luer connector  30  is in fluid communication with an inner surface  34  of first end  24  which is in fluid communication with evacuated tube  28 . In an alternate embodiment, the first mating portion may define a female luer connector, similar to connector  30 , and the second mating portion may define a male luer connector, similar to connector  20 . 
   Male luer connector  20  sealingly engages female luer connector  30  to establish fluid communication between male luer connector  20  and evacuated tube  28  thereby facilitating cord blood collection from umbilical cord  16  for appropriate sampling, analysis, etc. The sealing engagement of male luer connector  20  and female luer connector  30 , in accordance with the principles of the present disclosure, advantageously prevents hazardous exposure to blood and m body fluids by eliminating a needle seal and/or connection of housing  12  and the parts of fluid collection apparatus  10 . This structure reduces the number of needles employed to facilitate blood cord collection thereby increasing safety to practitioners and subjects. Further, the configuration of male luer connector  20  of housing  12  facilitates adaptability to pre-existing holders having female luer connectors. 
   Fluid collection apparatus  10  is contemplated for use in the medical field of body fluid collection. More particularly, fluid collection apparatus  10  is envisioned to be a disposable device for collecting umbilical cord fluids and having, among other things, safety features that include a needleless mating connection thereby preventing inadvertent needle sticking and hazardous exposure to blood and body fluids from practitioners and subjects, as well as uniform operation during a procedure. The above advantages, among others, realized from the present disclosure are attained through the disclosed fluid collection apparatus  10 , as discussed herein. The features of the present disclosure advantageously facilitate safe collection of body fluids. 
   Fluid collection apparatus  10  is integrally assembled of its component parts. Alternatively, portions of fluid collection apparatus  10  can be monolithically formed and assembled therewith. Component parts of fluid collection apparatus  10  can be fabricated from a material suitable for medical applications, for example, polymerics or metals, such as stainless steel, depending on the particular medical application and/or preference of a practitioner. Semi-rigid and rigid polymerics are contemplated for fabrication, as well as resilient materials, such as molded medical grade polypropylene. However, one skilled in the art will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate. 
   Housing  12  defines a flange  36  disposed adjacent and about an opening  38  of cavity  14 . Flange  36  provides stability to housing  12  and facilitates manipulation thereof. It is contemplated that flange  36  may be variously disposed about housing  12 . It is further contemplated that housing  12  may not include a flange. Cavity  14  is defined by walls  40  of housing  12 . Cavity  14  has a reduced dimension and is appropriately sized to receive a portion of umbilical cord  16 . Consequently, housing  12  is smaller and easier to manipulate. It is contemplated that housing  12  may be dimensioned to support an entire umbilical cord and/or various portions thereof. Housing  12  corresponds to the configuration of cavity  14 , however, the outer surface of housing  12  may alternatively have geometric configurations, such as, for example, rectangular, elliptical, etc. 
   Funnel  18  tapers from walls  40  to male luer connector  20  to direct cord blood collected in cavity  14  to male luer connector  20 . Varying degrees of funnel taper may be employed according to the requirements of a particular fluid collection application and/or preference of a practitioner. 
   Male luer connector  20  extends a sufficient length from funnel  18  to mate with female luer connector  30  of holder  22  in a slip interference fit. The slip interference fit includes a frictional engagement that maintains connectors  20 ,  30  in a sealing engagement. Female luer connector  30  correspondingly has a receiving depth at least a sufficient dimension to facilitate the slip interference fit with male luer connector  26 . The slip interference fit provides a needleless sealing engagement that avoids the use of a needle and prevents hazardous exposure to cord blood. 
   Male luer connector has a tapered outer surface  44  that is configured to engage a tapered inner surface  46  of female luer connector  30 . As outer surface  44  is caused to engage inner surface  46 , sufficient friction is created therebetween to generate the slip interference fit and seal housing  12  with holder  22 . The sealing engagement facilitates transfer of cord blood to evacuated tube  28  while avoiding needlesticks, splattering, etc. It is contemplated that surfaces  44 ,  46  may have variously tapered configurations, including non-tapered, depending on the sealing strength, etc. requirements of a particular medical application. It is further contemplated that male luer connector  20  may sealingly engage female luer connector  30  in various types of sealing engagements, such as, threaded friction fits, gasket, etc. sufficient to form a seal which facilitates fluid communication between housing  12  and evacuated tube  28 . 
   Male luer connector  20  has an opening  42  that is appropriately dimensioned to facilitate passage of fluid therethrough and avoid blockage due to particles, etc. in the cord blood and fluid. It is envisioned that opening  42  may include screens, filters, etc. As shown in  FIG. 3 , a locking surface  48  extends from funnel  18  and is disposed circumferentially about male luer connector  20 . Locking surface  48 , including a threaded portion  50 , extends an adequate length to receive a correspondingly threaded flange  52  of female luer connector  30 . Flange  52  threads with portion  50  to releasably lock housing  12  with holder  22 . Locking surface  48  may alternatively comprise circumferential notches disposed along male luer connector  20  which engage corresponding ridges of female luer connector  30  in a locked engagement. Other locking surfaces are contemplated such as, clips, catches, etc. It is contemplated that the locking surfaces may be permanent. 
   Referring to  FIGS. 5 and 6 , first end  24  of holder  22  has an inner surface  34 . Inner surface  34  has a needle hub  54  supporting a needle cannula  56 . Needle cannula  56  extends away from male luer connector  20  for appropriate puncture of a rubber stopper  58  of evacuated tube  28 . Needle hub  54  and needle cannula  56  are in fluid communication with female luer connector  30 . Needle cannula  56  engages rubber stopper  58  to establish fluid communication between male luer connector  20  and evacuated tube  28 . 
   Needle cannula  56  punctures rubber stopper  58  such that the tip of needle cannula  56  is disposed in the evacuated space of tube  28 . As needle cannula  56  communicates atmospheric pressure to the evacuated space of tube  28  via the fluid communication between housing  12  and evacuated tube  28 , cord blood  13  disposed in funnel  18  is drawn through male luer connector  20 , female luer connector  30 , needle hub  54  and needle cannula  56  into tube  28 . Cord blood  13  is drawn through this fluid flow path as pressure within tube  28  stabilizes to atmospheric pressure and the vacuum draws fluid therein. This fluid collection process is continued until tube  28  is filled or a desired amount of cord blood  13  is collected. Tube  28  is removed from needle cannula  56 . 
   In use, fluid collection apparatus  10  and its component parts, similar to that described, is properly sterilized and otherwise prepared for storage, shipment and use. Referring to  FIGS. 4–7 , a practitioner prepares the necessary instruments, including fluid collection apparatus  10  for collecting blood from an umbilical cord of a newborn. It is envisioned that component parts of fluid collection apparatus  10  employed, such as, for example, holder  22 , as described, may include pre-existing medical equipment for which housing  12  is easily adapted for use. 
   As shown in  FIGS. 4 and 5 , male luer connector  20  is mated to female luer connector  30  such that a non-puncturing sealing engagement is formed therebetween. Consequently, a seal is formed between housing  12  and holder  22 . Flange  52  threads with locking surface  48  to lock housing  12  with holder  22 . A length of umbilical cord  16 , which includes arteries, veins, etc. is clamped with surgical clamps (not shown) or the like. The length of umbilical cord  16  should be adequate for sampling, such as, for example, 8–30 centimeters. 
   As shown in  FIG. 6 , an end  60  of the length of umbilical cord  16  is placed in housing  12 . It is not required that the entire length of umbilical cord  16  be disposed within cavity  14  of housing  12 . Cord blood  13  is caused to flow into cavity  14  and pool in funnel  16 . Cord blood  13 , due to the fluid flow path communicating between housing  12  and female luer connector  30 , and gravity, flows to needle hub  54  and needle cannula  56 . 
   Evacuated tube  28  is inserted within cavity  27  of holder  27  to establish fluid communication between female luer connector  30  and evacuated tube  28  for collecting cord blood  13  via second end  26 . Rubber stopper  58  is driven into cavity  27  such that needle cannula  56  punctures rubber stopper  58 . Needle cannula  56  is disposed in the evacuated space of tube  28 . As discussed, cord blood  13  is drawn into the evacuated space of tube  28 . The collection of cord blood  13  is facilitated by the fluid communication established via the needless sealing engagement of male luer connector  20  and female luer connector  30 . 
   Housing  12  is drained of the remaining cord blood  64 , filling of tube  28  and/or acquisition of a sufficient sample. Tube  28  is removed from needle cannula  56  to discontinue cord blood collection, as shown in  FIG. 7 . The components of fluid collection apparatus  10  may be disposed and the cord blood sample may be analyzed, etc. 
   It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting but merely as exemplification of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.