Abstract:
A multiple chamber medical fluid bag includes: (i) a flexible enclosure; (ii) a first fluid chamber formed in the enclosure; (iii) a second fluid chamber formed in the enclosure; (iv) the first fluid chamber and the second fluid chamber separated by a frangible seal; and (v) an access port connected to the enclosure, the port imbedded into the enclosure so as to completely surround the access port, the enclosure further configured such that the frangible seal is broken to uncover the access port.

Description:
PRIORITY CLAIM 
     This application claims priority to and the benefit of U.S. patent application Ser. No. 11/625,683, filed, Jan. 22, 2007, entitled “Break Seal Before Access Dual Chamber Bag”, the entire contents of which are hereby incorporated by reference and relied upon. 
    
    
     BACKGROUND 
     The present disclosure relates to medical fluid solution bags and more particularly to dual chamber solution bags. 
     Various medical treatments, such as peritoneal dialysis, use dual bag solutions. Peritoneal dialysis solution is called dialysate. Dialysate has traditionally included lactate in a single chamber bag. More recently, dialysate has been made to be bicarbonate based. Bicarbonate is unstable in the presence of magnesium and calcium and forms a precipitate after a period of time. Accordingly, bicarbonate based dialysate needs to be packaged in a dual chamber supply bag. 
     The two chambers of the dual chamber bag are separated by a seal that a person breaks without tearing the entire bag. One such seal provided by the assignee of the present disclosure is termed a peel seal. Prior to use, the patient or caregiver breaks the seal between the two chambers and the solution from the two chambers is mixed and used before a calcium or magnesium precipitate can form. 
     The two unmixed solutions separated by the peel seal pose a risk. Each solution taken individually is physiologically unsafe for the patient. Accordingly, it is necessary to properly mix the individual solutions to form the final solution before injecting any of the solutions into the patient or contacting any of the solutions with the patient&#39;s blood. 
       FIG. 1  illustrates a known dual chamber bag  10 . A medical fluid system, such as a peritoneal dialysis system, is connected to bag  10  via an access system  20 . Access system  20  is connected fluidly to chamber  12 . When it is desired to use the combined solution within bag  10 , a frangible seal  14  is broken allowing solution A residing within chamber  16  to mix with solution B residing within chamber  12 . 
     As alluded to above, bag  10  presents an inherent risk. If after connecting the bag  10  to the patient, the seal between chamber  12  and access system  20  is broken before frangible seal  14  is broken (allowing solutions A and B to mix), a potentially physiologically unsafe solution B is allowed to reach the patient or to contact the patient&#39;s blood. 
     Accordingly, an improved dual chamber solution bag is needed. 
     SUMMARY 
     The dual chamber bags described herein can be used for different medical fluid therapies. In one embodiment, the dual chamber bag is a peritoneal dialysate bag. In another embodiment, the dual chamber bag stores dialysate used for hemodialysis, such as home hemodialysis. Here, the interest in home hemodialysis is increasing. Patients would typically rather have hemodialysis performed at home than in a center. In certain areas of the country, hemodialysis centers are located remotely, requiring a long drive or other transport on top of the time needed for the therapy itself. Further, performing treatment while the patient is relaxing or even sleeping lessens the interruption of the patient&#39;s active day. Bagged dialysate is also used for in-center hemodialysis treatments. The dual chamber bags described herein are also useful for substitution or replacement fluids, for example, for hemofiltration or hemodiafiltration, wherein it is again desirable to keep multiple solutions separate prior to use. 
     Described herein are dual chamber bags and processes for making the same, wherein in general, the frangible or peel seal needs to be broken before or in order to make a connection between the patient and the access system of the bag. Illustrated below are multiple embodiments for embedding the access system or access port within the bag. For example, the access port or access system can be embedded entirely within one or both of the chambers. 
     In each embodiment, a handle is provided that allows the user to pull the access system from within the dual chamber bag to make it available to be connected to a patient. The handle and the access port are connected to an intermediate or force transfer device that is in turn connected or part of the frangible or peel seal. For example, the intermediate device can be a cord, string, ribbon, monofilament or sheet of plastic. The plastic or film for example can be the same as that used to make the dual chamber bag. The intermediate or force transfer device is configured to withstand a force larger than that needed to break the frangible seal. The intermediate device is also configured to be part of or integrated with the peel seal. That is, it is formed with the seal used to separate the dual chambers from each other. 
     As seen herein, the dual chamber bags can have one or a plurality of frangible seals. The seals can be located perpendicular to or parallel to a direction of the access port. For example one seal can be used to separate the two chambers, while a second seal separates the access system from the rest of the bag. 
     As seen below, the access port is buried within the bag, isolating it from the patient until the main seal is broken. The bag in certain embodiments is folded multiple times to achieve a desired configuration relative to the access system. During the folding process, the force transfer or intermediate device linking the handle with the seal is applied, e.g., welded, to the bag. 
     As further seen below, one or more sides or seams of the bags are welded, e.g., sonically, via heat seal and/or chemically welded. The folds and the welds result in a dual chamber bag that partially or completely embeds the access system until the main peel seal separating the two chambers is broken. 
     It is therefore an advantage of the present disclosure to provide a dual chamber medical fluid bag having increased safety. 
     It is another advantage of the present disclosure to provide a dual chamber bag in which a frangible seal separating first and second individual solutions needs to be broken before an access system allowing access to the dual chamber bag can be reached and connected to the patient. 
     It is a further advantage of the present disclosure to provide a dual chamber bag that is relatively easy to form. 
     It is another advantage of the present disclosure to provide a dual chamber bag that is made of relatively inexpensive components. 
     Additional features and advantages are described herein, and will be apparent from, the following Detailed Description and the figures. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  is an elevation view of a prior art dual chamber bag. 
         FIGS. 2 to 5A  are elevation views illustrating one dual chamber bag and method of making same according to the present disclosure. 
         FIG. 5B  is an alternative dual chamber bag to the one shown in connection with  FIG. 5A . 
         FIGS. 6 to 9  are elevation views illustrating another dual chamber bag and method of making same according to the present disclosure. 
         FIG. 10  is an elevation view of an alternative embodiment of the dual chamber bag of  FIG. 9 . 
         FIGS. 11A to 11C ,  12 A,  12 B,  13 A,  13 B,  14 A,  14 B,  15 A,  15 B,  16 A,  16 B,  17 A,  17 B,  18 A,  18 B,  19 A,  19 B and  20 A and  20 B illustrate a further alternative of a dual chamber bag and method of making same according to the present disclosure. 
         FIGS. 21 to 23  illustrate yet another alternative dual chamber bag and method of making same according to the present disclosure. 
         FIGS. 24 to 26  illustrate still another alternative dual chamber bag and method of making same according to the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Referring now to  FIGS. 2 to 5A , a first embodiment for and method of making a dual chamber bag according to the present disclosure is illustrated by bag  30  (completed in  FIG. 5A ).  FIG. 2  illustrates a first manufacturing figure for dual chamber bag  30 . Here, an overall enclosure  32  is formed by folding a piece of material for enclosure  32  along fold line  34 . The material for enclosure  32  and indeed for each of the enclosures discussed herein is any one or more of polyvinyl chloride (“PVC”), Japanese polyolefinic container (“JPOC”), propylene/ethylene copolymer (“cPP”), polypropylene (“PP”), polyamide (“PA”) and combinations thereof. Sides  36   a  and  36   b  and  38   a  and  38   b  are welded together as shown via the X&#39;s or weld marks. Suitable processes for forming weld seams  36   a ,  36   b ,  38   a ,  38   b  and indeed each of the welded seams discussed herein include chemical bonding, heat sealing, ultrasonic sealing, radio frequency sealing, microwave sealing and combinations thereof. 
     As seen, a string or pull handle  40  is welded into a portion of seams  38   a  and  38   b , such that a first portion  40   a  of string  40  resides outside of enclosure  32 , while a second portion  40   b  of string  40  is looped inside enclosure  32 . Suitable material for string  40  includes any of the materials listed above. Inner portion  40   b  can be welded to seams  38   a  and  38   b  after such seams have been formed. Alternatively, inner portion  40   b  of string  40  is welded with seams  38   a  and  38   b  to form enclosure  32 . 
     An access system  50  is welded to enclosure  32  at welded seam  42 , which is located distally from folded seam  34 . Access system  50  includes a connector  52  that connects to a line leading to a disposable cassette used with a medical fluid machine, such as a peritoneal dialysis, hemodialysis, hemofiltration or other type or renal failure therapy device. Alternatively, the line is a solution line of a manual peritoneal dialysis therapy or continuous ambulatory peritoneal dialysis (“CAPD”) treatment. Access system  50  also includes a seal  54 , which blocks solution from existing access system  50  until a connection is made with connector  52 . 
     In  FIG. 3 , the process for embedding access system  50  within enclosure  32  is begun. Here, distal seam  42  is pushed vertically upwards towards folded seam  34 , causing welded seams  38   a  and  38   b  to buckle, such that a continuous or annular groove  44  begins to form between an outer portion  46  of seams  38   a  and  38   b  and an inner portion  48  of those seams. 
       FIG. 4  illustrates access system  50  embedded completely within enclosure  32 . Access system  50  is now surrounded completely by continuous groove or opening  44  created by pushing distal seam  42  connected to access system  50  towards folded line  34 . It should be noted that even though access system  50  is embedded with enclosure  32 , access system  50  remains external to the enclosure. Only portion  40   b  of string  40  is actually inside enclosure  32 . 
     Referring now to  FIG. 5A , one embodiment of a completed dual chamber bag according to the principals of the present disclosure is illustrated by bag  30 . A peel seal  56   a  is made to separate enclosure  32  into first fluid chamber  58   a  and second fluid chamber  58   b . One suitable apparatus and method for forming the peel seal or frangible seal  56   a  is set forth in U.S. Pat. No. 6,319,243, entitled, “Containers and Methods for Storing and Admixing Medical Solutions”, assigned to the eventual assignee of the present application, the entire contents of which are incorporated herein expressly by reference and relied upon. Importantly, inner portion  40   b  of string or handle  40  is embedded within and extends through peel seal  56   a . In this way, when the patient or caregiver pulls string or handle  40 , inner portion  40   b  is configured and positioned to tear peel seal  56   a  and allow a first fluid residing within first fluid chamber  58   a  to mix with a second fluid residing within a second fluid chamber  58   b.    
     Access system  50  is relatively inaccessible to the patient or caregiver before that person pulls string or handle  40  to tear frangible seal  56   a  and expose access system  50 . It is possible however that if someone labored hard enough, they could locate access system  50  within the folds creating opening  44  and puncture seal  54  before pulling string or handle  40 . Accordingly, and optionally, a second frangible seal  56   b  is provided at the open end of opening  44 , which seals that open end until handle  40  is pulled, tearing second frangible seal  56   b . Here, second peel seal  56   b  can be fixed or fastened to handle  40 , such that it is carried with handle  40  as exposed section  40   a  of handle  40  is pulled. As seen in  FIG. 5B , second frangible seal  56   b  does not have to fully close the open end of opening  44  but merely make reaching access system  50  impossible or at least highly improbable and impractical. 
     Referring now to  FIG. 5B , an alternative version of dual chamber bag  30  is illustrated. Dual chamber bag  30  of  FIG. 5B  is like dual chamber bag  30  of  FIGS. 1 to 5A  in all respect except that inner portion  40   b  of handle  40  includes multiple string loops or is otherwise expanded such that when exposed portion  40   a  of handle or string  40  is pulled, the multiple loops or expanded version of inner portion  40   b  tears open a larger portion of peel seal  56   a , increasing the ability of first and second fluids located within first and second chambers  58   a  and  58   b  to mix properly and efficiently. 
     Referring now to  FIGS. 6 to 9 , a second primary embodiment of the dual chamber solution bag according to the present disclosure is illustrated by bag  60  ( FIG. 9 ).  FIGS. 6 to 8  show various stages of manufacturer of bag  60 .  FIG. 9  shows one embodiment for completed bag  60 .  FIG. 10  shows another embodiment for dual chamber bag  60 . 
     One primary difference between bag  60  and bag  30  of  FIGS. 5A and 5B  is that the pull string of bag  30  is replaced by handle  70 , which in the illustrated embodiment is a piece of plastic film or sheeting, such as the same sheeting used to form enclosure  62 . Enclosure  62  also has a different shape than enclosure  32  of bag  30 . Another primary difference for dual chamber bag  60  is that enclosure  62  is folded at the bottom of the bag, near handle  70 , and is welded at opposing upper seam  64 . As seen in  FIGS. 6 to 9 , sheet handle  70  includes an outer pull portion  70   a , which resides outside chamber  62 , and which defines an aperture  82  sized for example to accept a finger or fingers of the patient or caregiver. Handle  70  also expands in size at an inner portion  70   b , which is maintained within enclosure  62 . The larger portion  70   b  is sized to open all or most all of a frangible or peel seal when the patient or caregiver grasps and pulls handle  80 . 
       FIG. 7  illustrates that enclosure  62  is formed by folding the enclosure at fold line  72   a , such that upper seam  64 , and side seams  66   a ,  66   b ,  68   a  and  68   b  can be welded via any of the embodiments discussed herein. Also, enclosure  62  is welded at seams  72   b  and  72   c  discussed in further detail below.  FIG. 7  further illustrates how sheeting handle  70  is integrated into enclosure  62 , namely, it is inserted near the bottom of enclosure  62 , so that a curved edge  84  of handle  70  comes into substantial alignment with curved seam  68   a  of enclosure  62 . 
       FIG. 8  illustrates a sealed enclosure  62  prior to the enclosure being folded into itself to protect against inadvertent breaking of seal  54  of access system  50 . Here, handle  70  is sealed within enclosure  62 , such that portion  70   b  resides within enclosure  72  and portion  70   a  remains outside of enclosure  72 . Enclosure  62  is welded at seams  64 ,  66   a ,  66   b ,  68   a ,  68   b  and  72   b . The upper end of enclosed portion  70   b  of handle  70  expands at an area where a first frangible or peel seal is made as seen in  FIG. 9 . 
     Seal  68   b  does not include the side of the portion  70   b  of handle  70 . That is, sides of enclosure  62  are welded together to form  68   b . Likewise, seal  68   a  does not include edge  84  of handle  70 . Seal  72   b  however does include handle  70 . In this manner, enclosure  62  at seal  72   b  moves with handle  70  as handle  70  is grasped and pulled, which in turn moves inner portion  70   b  of handle  70  relative to seals  68   a  and  68   b.    
       FIG. 9  shows a completed dual chamber bag  60 . Here, enclosure  62  is folded within itself to form inner opening  74 , which includes a continuous opening around an inner opening wall  78  and outer opening wall  76  of enclosure  62 . Enclosure  62  is folded into itself until access system  50  is hidden within enclosure  62 . 
     First and second frangible seals  56   a  and  56   b  are then applied to enclosure  62 . Frangible seal  56   a  seals sheets of enclosure  62  and an upper end  80  of handle  70 . Upper end  80  spans substantially all of the width of enclosure  62 , such that seal  56   a  opens a large area for solution A housed in first chamber  88   a  to mix properly and readily with solution B maintained within chamber  88   b . As illustrated, frangible seal  56   a  separates chamber  88   a  from chamber  88   b.    
     A second frangible seal  56   b  is provided to separate solution B of chamber  88   b  from an access area and from reaching access system  50 . When the patient or caregiver pulls handle  70 , e.g., via opening  82 , inner portion  70   b  tears through frangible seals  56   a  and  56   b  virtually simultaneously, so that solutions A and B mix and also so that the mixed solution reaches seal  54  of access system  50  for the first time. Thus, even if the patient breaks access system seal  54  prior to opening peel seals  56   a  or  56   b , no single solution can reach the patient. Alternatively, portion  70   b  is welded with seams  68   a  and  68   b , and seal  56   b  is broken by applying pressure to the outside of enclosure  62  after frangible seal  56   a  is broken. 
     It is possible with bag  70  that frangible seal  56   b  could be broken before frangible seal  56   a  is broken, enabling only solution B to reach access assembly seal  54 . If the patient or caregiver then breaks frangible seal  54 , solution B alone could reach the patient. To remedy the above,  FIG. 9  illustrates an alternative embodiment for dual chamber bag  60 , in which access system  50  is rotated ninety degrees with respect to its position in bag  60  of  FIG. 9 . In dual chamber bag  60  of  FIG. 10 , access system  50  is very difficult to locate and open until handle  70  is pulled and both frangible seals  56   a  and  56   b  are broken. The configuration of access system  50  in  FIG. 10  adds another layer of security and safety to dual chamber bag  60 . A 2   
     Referring now to  FIGS. 11A to 11C ,  12 A,  12 B,  13 A,  13 B,  14 A,  14 B,  15 A,  15 B,  16 A,  16 B,  17 A,  17 B,  18 A,  18 B,  19 A,  19 B and  20 A and  20 B a yet further alternative dual chamber bag of the represent disclosure and method of making same is illustrated by bag  90  ( FIGS. 20A and 20B ).  FIGS. 11A to 11C  show three different configurations for enclosure  92  of the dual chamber bag  90 .  FIG. 11A  illustrates an enclosure  92  having a stepped shaped bottom.  FIG. 11B  illustrates enclosure  92  having a triangular shaped bottom.  FIG. 11C  illustrates enclosure  92  having a rounded bottom. For purposes of illustration, the stepped shaped bottom of  FIG. 11A  is shown in the remaining figures. It should be appreciated however that the teachings shown in the remaining figures are applicable to any of the configurations of enclosure  92  of  FIGS. 11A to 11C  and to other suitable shapes that may be readily formed by those skilled in the art. 
       FIGS. 12A and 12B  show that the first step in the manufacturer of dual chamber bag  90  is to fold enclosure  92  at fold line  94 .  FIGS. 13A and 13B  illustrate that the next step includes the formation of welded seams  96   a  and  96   b  along a portion of the sides of enclosure  92 . Also, access system  50  is welded to enclosure  92  at fold line  94 . Further, a handle  100 , such as a loop or tab, is welded to the outside of enclosure  92 . 
       FIGS. 14A and 14B  illustrate the addition of the first frangible seal  56   a , which separates access system  50  from the remainder of enclosure  92 . Air is maintained between frangible seal  56   a  and access system  50 .  FIGS. 15A and 15B  illustrate a second folding operation resulting in second fold lines  98  and the creation of channel  102  between the access system  50  and handle  100  area and the outer sheets of enclosure  92 . 
     Referring now to  FIGS. 16A and 16B , another step in the manufacturer of dual chamber bag  90  is the addition of welded seams  104   a  and  104   b , which further enclose chamber  102 .  FIG. 16B  shows how weld  104   b  is made around inner weld  96   b .  FIGS. 17A and 17B  illustrate a third folding operation, in which fold lines  106  are created by folding enclosure  92  at a portion of weld seams  104   a  and  104   b . The additional fold creates an outer chamber  108 , which surrounds inner chamber  102 . 
       FIGS. 18A and 18B  illustrate the addition of outer welds  110   a ,  110   b  and  112 . Outer welds seal outer chamber  108  completely.  FIGS. 19A and 19B  illustrate the addition of the second peel seal or frangible seal  56   b . The second frangible seal  56   b  is made to divide outer chamber  108  into first fluid holding chamber  114   a  and second fluid holding chamber  114   b  as seen best in  FIG. 19B . Frangible seal  56   a  seals access system  50  from chamber  114   a  as seen in  FIG. 19B . 
       FIGS. 20A and 20B  illustrate the dual chamber bag  90  in further detail.  FIG. 19B  is a section view of  FIG. 19A  taken along line XX-XX shown in  FIG. 19A .  FIG. 20B  shows the general shape of first chamber  114   a  and second chamber  114   b . It also shows that frangible seals  56   a  and  56   b  are aligned and overlapping. Second chamber  114   b  is an annular or continuous chamber in which a second solution is trapped between outer and inner cylindrical or continuous walls. The second chamber  114   b  surrounds an empty space in which access system  50  and handle  100  are located. 
     When the user pulls handle  100 , peel seal  56   b  between chambers  114   a  and  114   b  is subjected to a force almost perpendicular to the walls of container  90 , due to the folding of film of enclosure  92 . In contrast, frangible seal  56   a  in the inner layers does not experience any stress during this action since the two inner most layers move together in the same direction. As a consequence of this difference in the direction of forces, frangible seal  56   a  separating chambers  114   a  and  114   b  breaks before inner frangible seal  56   a , guaranteeing that mixing takes place before any liquid can reach seal  54  of access system  50 . In the illustrated embodiment, frangible seal  56   b  is broken by applying pressure to the mixed open chambers, such that the increased pressure of the liquid causes frangible seal  56   a  to open and fluid to flow to access system  50 . 
       FIGS. 21 to 23  illustrate still a further alternative dual chamber bag  120  and method of making same, which includes the provision of a vertical frangible seal after access system  50  is pushed as far as it can go into enclosure  122 .  FIG. 22  shows that enclosure  122  at access system  50  is pushed into itself until that portion meets upper distal wall  124  of enclosure  122 . String  40  in enclosure  120  is maintained wholly outside of enclosure  122  and indeed can be welded to the outside of enclosure  122 . Access system  50  is welded at seam  126  to upper edge  124  of enclosure  122 . 
       FIG. 23  illustrates that upper and lower frangible seals  56   a  and  56   b  (located one on top of the other) separate and form first and second chambers  128   a  and  128   b . When the user pulls cord  40 , access system  50  is pulled through both upper and lower frangible seals  56   a  and  56   b , allowing first and second fluids in first and second chambers  128   a  and  128   b , respectively, to mix. It should be appreciated that even if the user some how punctures seal  54  of access system  50  prior to pulling access system  50  through first and second frangible seals  56   a  and  56   b , weld  126  seals first and second chambers  128   a  and  128   b  from access system  50 , such that no fluid can be transferred to the patient. 
       FIGS. 24 to 26  illustrate another vertical frangible seal embodiment. This embodiment includes three frangible seals  56   a ,  56   b  and  56   c . Dual chamber container  130  includes an enclosure  132  formed in much the same way as is enclosure  92  of container  90  discussed above. Here, first seal  56   a  forms a safety seal between enclosure  132  and access system  50 . Thus even if the patient or user breaks seal  54  of access system  50  prior to vertical frangible seals  56   b  and  56   c  being broken, frangible seal  56   a  isolates access system  50  from enclosure  132 . Vertical peel seals  56   b  and  56   c  as seen in  FIGS. 24 and 26  separate enclosure  132  into first and second fluid carrying chambers  134   a  and  134   b . The user pulls handle or cord  40 , which is completely external to chamber  132  to rip an upper inner edge  136  of enclosure  132  through frangible seals  56   b  and  56   c , allowing fluid from first and second chambers  134   a  and  134   b  to mix. 
     It should be appreciated that many of the dual chamber containers described herein, such as container  130  can be opened readily for example by hanging cord  40  around a door handle and allowing enclosure  132 , holding first and second fluids to drop hangman style to automatically mix the first and second fluids. Here, access system  50  points vertically upward (imagine container  130  in  FIG. 25  turned upside down), such that the weight of fluid will not place any pressure on safety frangible seal  56   a . The user can then squeeze dual chamber container  130  to pop or open frangible seal  56   a.    
     It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.