BACKGROUND OF THE INVENTION

The present invention relates to a system for properl identifying the patient, specimens and blood units through out all stages of a blood transfusion sequence, starting with the patient registration at the hospital admission desk. The system ensures that the patient receives the proper type of blood unit and provides a combination lock which may be only opened with the proper code assigned to the patient.

It is well known that the technology for drawing, st ing and subsequently issuing blood units to the proper patient is susceptible to human error and that an urgent need exists for improvement. In the prevention of blood transfusion errors, which may be fatal to the patient, co rect identification between the patient and the blood typ is of utmost importance.

In most blood transfusion systems, there are several stages where reliance must be placed upon human visual checks. Starting with the drawing of a blood specimen fr a patient, through internal blood bank procedures and end with delivery and administration of the blood unit to the patient, visual checks must be made at every step of the system to ensure the proper application of blood to the patient. Quite obviously, any system which relies upon visual checks is susceptible to human error.

Systems are known which incorporate a holder bag in which the blood unit container is stored and wherein a co bination locking cap is placed over the holder bag openin The combination on the locking cap is set to match a code given to the patient and illustrated on the patient I. D. wristband. The locking cap may not be removed unless th

code properly matches that attached to the patient. The combination is set by physically removing a tab from, or inserting a peg into, either the cap or the hollow member surrounding the opening of the holder bag. A drawback to this system is that the setting of the combination require additional tools to break the tab or insert the peg and that, once set, the combination is fixedly attached to the bag, which renders the bag unusable thereafter. Once the blood unit is used, the locking cap, along with the holde bag must be disposed of to prevent subsequent improper usage.

It is also well known to provide a flexible storage having means to lock an opening thereof to prevent unauth rized access to the contents of the bag. However, these systems typically incorporate a key lock structure physi¬ cally attached to the bag, thereby preventing the usage o the lock with another bag structure.

SUMMARY OF THE INVENTION

The present invention provides a system for positive identification between a patient and a blood unit to be administered to the patient, and incorporates a combinati lock which prevents access to the blood unit unless the proper code is set so as to enable its removal. A wristb I. D. attached to the patient incorporates an alphabetic code, which may have three letters. Each patient is assigned a different three letter code upon registration the hospital admission desk. A blood specimen is drawn i the normal fashion and the patient's wristband code is copied onto the specimen tube label and onto any requisit forms that are necessary. Once delivered to the registra tion station of the blood bank, an accession number is assigned to the specimen tube and the patient's code lett are entered into the registration log book.

Once the specimen has been analyzed and the type of

blood required has been determined, a blood unit of this type is reserved in the normal fashion. The patient's letter code does not appear on the blood bag label, which contains only the usual donor and patient information. A the dispensing station of the blood bank, the reserved bl unit is placed into an outer bag of opaque plastic materi having two circular cutouts near its open top portion. T outer bag is then closed and locked by inserting the comb nation lock according to the invention through the circul cutouts. This lock fastens the bag opening and prevents access to the blood unit bag stored therein until its removal by setting the proper code.

The combination lock comprises a holder element, whi is inserted through the circular cutouts in the outer bag and a combination locking element which attaches to the holder element so as to grip the bag therebetween. The technologist placing the blood unit bag within the outer sets the combination locking element to match that in the registration log book and, by manually exerting a compres sive force thereon, permanently sets the proper combinati Subsequent turning of the combination dials and snapping onto the holder element renders the two elements positive locked together until the proper combination is set on t combination dials.

At the transfusion site, the letter code on the patient's wristband is dialed 25 onto the combination lo ing element and, if the combination is proper, the combi tion element may be removed from the holder element so a open the outer bag and allow access to the blood unit ba If the improper letter code is utilized, the combination locking element will not open and inadvertent access to blood unit bag is positively prevented.

The combination lock according to this invention is disposable and, since both the combination element and t holder element are removable from the outer bag, the out

bag may be reused a number of times. It is simple in opera tion, since by merely setting the combination dials and by physically forcing them together, the combination is perma¬ nently set and may not be changed. Setting the combinatio requires no additional tools or mechanical skill on the pa of the user. BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1 is a partial, perspective view of a patient identification wristband having a three letter code accord ing to the invention.

FIGURE 2 is a front view of the outer bag having the combination lock 5 attached thereto.

FIGURE 3 is a partial side view of the outer bag with the holder element and the combination element in their locked positions.

FIGURE 4 is an exploded, side view showing the outer bag, the holder element and the combination element in the unlocked positions.

FIGURE 5 is a front view of the combination lock assembly according to the invention.

FIGURE 6 is a cross-sectional view of the combination lock assembly taken along line 6-6 in FIGURE 5 before the combination has been set.

FIGURE 7 is a cross-sectional view of the combination lock assembly taken along line 7-7 in FIGURE 5 before the combination has been set.

FIGURE 8 is a cross-sectional view taken along line 8 in FIGURE 16.

FIGURE 9 is a side view, partially in section, showin the clasp member of the combination lock element assembled thereto before setting the combination.

FIGURE 10 is an exploded, sectional view of the combi nation lock assembly 20 according to the invention.

FIGURE 11 is a rear view of the clasp member associa with the combination lock element according to the invent

taken along line 11-11 in Figure 10.

FIGURE 12 is a front view of the base disk of the com bination lock assembly 25 taken along line 12-12 in FIGURE 10.

FIGURE 13 is a front view of the first locking ring taken along line 13-13 in FIGURE 10.

FIGURE 14 is a front view of the second locking ring taken along line 14-14 in FIGURE 10.

FIGURE 15 is a cross-sectional view of the combinati lock assembly assembled to the holder element taken along line 6-6 in FIGURE 5, after setting the combination.

FIGURE 16 is a cross-sectional view of the combinati lock assembly in its assembled position taken along line in FIGURE 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Figure 1 illustrates a standard patient identificati wristband 10 which is typically attached to each incoming patient in a hospital. Each I. D. wristband has a three letter code thereon, illustrated as LIT. It should be understood that, although the invention will be described terms of a three letter combination code, codes having mo or less letters or numbers may be utilized without exceed the scope of this invention. It is anticipated that each letter position may have 24 different letters so as to al 13,284 different three letter combinations to be utilized The wristbands will be sequentially issued to incoming patients and, with the total number of combinations avail able, will provide a sufficient amount of time such that even the largest hospital will not have to utilize the s combinations.

As indicated previously, the blood specimen withdra from the patient will have the patient's combination cod affixed thereto. Once the type of blood required by the patient has been determined, the proper type is reserved standard, blood unit containers. The patient's code doe

not appear on the blood unit container.

When it is necessary to administer the blood unit to the patient, the blood unit container 12 is withdrawn from storage and placed within an outer bag 14. Outer bag 14 i formed of an opaque plastic material and has an opening along one edge such that the blood unit container 12 may b readily inserted therein. The sides of the outer bag 14 define a pair of generally cylindrical openings 16 which a aligned when the edges of the bag are brought together.

The open end of outer bag 14 is secured by the combin tion lock system 25 according to this invention. As shown in Figure 4, the combination lock system comprises a holde element 18, having a substantially planar portion 20 and a engaging portion 22 extending therefrom, and a combination lock assembly 24. The combination lock assembly, to be described in more detail hereinafter, has a plurality of indicia rings, in this particular instance 3 rings, each o the indicia rings having 24 letters thereon. As best seen in Figures 2 and 5, each of the indicia rings may be indiv dually rotated so as to align one of the letters on its fa with the arrow 26 formed on clasp member ^* 28.

When the proper blood unit has been placed in outer 14, the technician ascertains the patient's letter code f the registration log book and encodes this three letter combination into the combination lock assembly 24. As wi be explained in more detail hereinafter, this may be acco plished by merely aligning the proper three letters with arrow 26 and physically snapping the indicia rings agains base portion. Once the combination lock assembly 24 has been thusly encoded, holder element 18 is inserted throug the cylindrical openings 16 such that portion 20 bears against one side of bag 14 while the element 22 extends through the opening. Combination lock assembly 24 is the slipped over element 22 such that flexible tab member 30 engages a corresponding slot in the combination lock

assembly 24. The base portion of the combination lock assembly 24 bears against the opposite side of the bag 14 and, when the indicia rings are randomly rotated, the two elements are locked together. This positively seals the opening of opaque bag 14 such that it may be opened only when the proper combination code is set on the indicia rings.

In order to remove the blood unit container 12 from outer bag 14, it is necessary for the technician to obser the code on wristband 10 and to arrange the indicia rings the proper coded order. If it is the proper code for the patient, combination lock assembly 24 and holder element may be removed from the bag and discarded. The blood uni container 12 may then be removed, from outer bag 14 and administered to the patient in the normal fashion. Outer bag 14 may be returned to the blood bank for further usag However, should the blood unit be incorrect, the code on patient's wristband will not enable the combination lock assembly to be removed, thereby preventing incorrect admi sion of the blood unit.

The combination lock assembly 24 is shown in an ex¬ ploded, cross-sectional view in Figure 10. This assembly comprises a base member 32 of generally circular configur tion, as shown in Figure 12. Base member 32 defines a c tral opening 34 and has a pair of generally upstanding, diametrically opposed walls 36. The outer surfaces of w 36 are generally curved so as to match the curvature of central opening 34. Inner surfaces of walls 36 define a first pair of diametrically opposed notches 38 and a sec pair of such notches 40. Locating bosses 42a and 42b al extend generally perpendicularly from base disk 32. The opposite surface of base disk 32 defines a groove 44 ext ing generally adjacent the bases of locating bosses 42 s to form an area of reduced cross-sectional thickness adj cent the bosses. This area of reduced thickness enables

locating bosses 42 to be frangibly attached to the base member 32 such that a force generated against the locating bosses 42 will cause them to break away from base member 3

A first locking ring 46 is placed onto base member 32 such that openings 48, defined through locking ring 46, allow passage of the locating bosses 42a and 42b there¬ through. Locking ring 46 also defines a central opening 5 with a locking notch 52 extending longitudinally from one side of opening 50. When locking ring 46 is assembled ont base member 32 such that locating bosses 42 extend through openings 48, locking notch 52 coincides with locking notch 54 formed in the base member 32.

The lengths of locating bosses 42a and 42b are such that locating bosses 42a do not extend beyond the surface 42a of locking ring 46 when it is assembled onto base memb 32. Locking ring 46 also defines an annular recess 46b on surface 46a. The outer wall defining the recess 46b also defines a plurality of locking bosses 54 which extend gene ally radially inwardly into the recess 46b.

A first indicia ring 56 having the alphabetic indicia on surface 56a is placed over locking ring 46 such that it may rotate with respect thereto. Central opening 58, defined by indicia ring 56 has a diameter larger than the distance between locating bosses 42b such that they may p through this opening and not restrict the relative rotati between the indicia ring 56 and locking ring 46.

A second locking ring 60 of generally circular confi ration whose outer diameter is less than the diameter of opening 58 is placed within opening 58 such that locating bosses 42b extend through openings 62 defined therein. Second locking ring 60 also defines a longitudinal lockin groove 64 which is in alignment with locking grooves 52 a 54 when it is assembled onto locating bosses 42b. Annula recessed portion 60a is formed in locking ring 60 and the outer wall of the recessed portion defines a plurality of

locking bosses 66.

Second indicia ring 68 is rotatably placed over secon locking 60 such that it may rotate with respect thereto. Indicia ring 68 has the alphabetic indicia on surface 68a and defines a central opening 70, the diameter of which is greater than the lateral distance between locating bosses 42b. Thus, when these elements are assembled onto base member 32, indicia ring 68 may readily rotate with respect to locking ring 60 without interference from locating boss 42b.

Third locking ring 72, of generally circular configu tion, whose outer diameter is slightly less than the dia¬ meter of opening 70 is placed into indicia ring 68. Lock ring 7 ^' 2 defines a pair of diametrically opposite, longitu nally extending notches 74 which extend partially around locating bosses 42b so as to prevent rotation of locking ring 72 with respect to base member 32. Locking ring 72 also defines a central opening 76 and a locking notch 78. When locking ring 72 is engaged with locating bosses 42b, locking notch 78 is in longitudinal alignment with lockin notches 64, 52 and 54. A recessed area in surface 72a of locking ring 72 defines a plurality of generally radially inwardly extending locating bosses 80.

Third indicia ring 82 defining central opening 84 is placed over locking ring 72 such that it may rotate with respect thereto. Indicia ring 72 has the alphabetic indi on surface 82a.

The foregoing elements are retained in assembled rel tionship by clasp 10 member 28. Clasp member 28 has a generally planar portion 86 with a pair of walls 88 exten ing generally perpendicular therefrom. Each of the walls has a latch member 90 extending therefrom. The clasp me 28 is formed of material such that walls 88 are resilien deformable. As can be seen in Figure 10, clasp member 2 inserted through all of the locking rings and indicia ri

such that the exterior surfaces of walls 88 slide along th interior surfaces of walls 36 formed on base member 32. Clasp member 28 is inserted until latch elements 90 engage first notch 38, as illustrated in Figures 6 and 9. The lateral portions of planar portion 86 bearing against indi cia ring 82 prevents the elements from becoming dis¬ assembled. While in this condition of assembly, each of t indicia rings may be rotated independently of each other a with respect to their adjacent locking rings. Thus, while the unit is assembled and may be easily handled as such, each of the indicia rings is independently anipulable.

As best seen in Figures 6 and 7, in this assembled condition, a certain spacing s exists between each of the indicia rings and between the base member 32 and indicia ring 56. The combination lock assembly 24 is in this assembled relationship prior to its attachment to the oute bag 14. In order to set the code, the technician merely turns each of the indicia rings such that the proper code letter is aligned with arrow 26 formed on clasp 28, as illustrated in Figure 5. Although the indicia rings may b readily turned, each of the locking rings 46, 60 and 72, i prevented from rotating by their engagement with locating bosses 42a and 42b. Thus, the locking notches 54, 52, 64 and 78 remain in alignment.

Once the proper code has been located adjacent arrow 26, the operator need only force clasp member 28 downwardl into base member 3-2 until latch members 90 engage second notch 40, as shown in Figures 15 and 16. This downward movement causes a reduction in the space s between the adjacent elements which, in turn, causes indicia rings 68 and 56 to bear downwardly against the top of locating bos 42b and 42a respectively. This downward force fractures reduced thickness area of base member 32 adjacent the loc ing bosses and causes them to break away from the base me ber 32. At the same time, this downward movement of the

indicia rings with respect to the adjacent locking ring serves to rotatably affix the indicia ring with its respec tive locking ring such that relative rotation may no longe take place. This is achieved by engagement of one or more latching bosses 56b, 68b or 82b formed on the indicia ring with locking bosses 54, 66 and 80, respectively. Once the indicia ring is forced downwardly onto the associated lock ing ring, the latching bosses formed on the locating ring extends between two of the locking bosses formed on the locking rings, identified as elements 54, 66 and 80. Once the code is set, the indicia rings are randomly rotated so as to mis-align locking notches 54, 52, 64 and 78.

In order to attach the combination lock assembly 24 t the holder element 18, it is merely necessary to slide the assembly over engagement portion 22 extending through the outer bag 14. Latching leg 30, having a latching element thereon, is resiliently deformable such that it is deforme inwardly until it snaps into locking ring 72 as illustrate in Figure 16. Once locking element 92 is in this position it is not possible to separate combination lock element 24 from holder element 18 unless the locking notches 78, 64, and 54 are in alignment. This alignment is only achieved when the proper letter code combination is aligned with arrow 26. Thus, unless the proper code is placed on the combination lock, the elements cannot be separated and inadvertent access to the blood unit within the holder ba 14 is positively prevented.

The foregoing description is provided for illustrati purposes only and should not be construed as in any way limiting this invention, the scope of which is defined solely by the appended claims.