Break seal before access dual chamber bag

A multiple chamber medical fluid bag including: (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 enclosure folded so as to cover the access port and so that the frangible seal is broken to uncover the access port.

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's blood.

FIG. 1illustrates a known dual chamber bag10. A medical fluid system, such as a peritoneal dialysis system, is connected to bag10via an access system20. Access system20is connected fluidly to chamber12. When it is desired to use the combined solution within bag10, a frangible seal14is broken allowing solution A residing within chamber16to mix with solution B residing within chamber12.

As alluded to above, bag10presents an inherent risk. If after connecting the bag10to the patient, the seal between chamber12and access system20is broken before frangible seal14is 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'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'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.

DETAILED DESCRIPTION

Referring now toFIGS. 2 to 5A, a first embodiment for and method of making a dual chamber bag according to the present disclosure is illustrated by bag30(completed inFIG. 5A).FIG. 2illustrates a first manufacturing figure for dual chamber bag30. Here, an overall enclosure32is formed by folding a piece of material for enclosure32along fold line34. The material for enclosure32and 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. Sides36aand36band38aand38bare welded together as shown via the X's or weld marks. Suitable processes for forming weld seams36a,36b,38a,38band 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 handle40is welded into a portion of seams38aand38b, such that a first portion40aof string40resides outside of enclosure32, while a second portion40bof string40is looped inside enclosure32. Suitable material for string40includes any of the materials listed above. Inner portion40bcan be welded to seams38aand38bafter such seams have been formed. Alternatively, inner portion40bof string40is welded with seams38aand38bto form enclosure32.

An access system50is welded to enclosure32at welded seam42, which is located distally from folded seam34. Access system50includes a connector52that 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 system50also includes a seal54, which blocks solution from existing access system50until a connection is made with connector52.

InFIG. 3, the process for embedding access system50within enclosure32is begun. Here, distal seam42is pushed vertically upwards towards folded seam34, causing welded seams38aand38bto buckle, such that a continuous or annular groove44begins to form between an outer portion46of seams38aand38band an inner portion48of those seams.

FIG. 4illustrates access system50embedded completely within enclosure32. Access system50is now surrounded completely by continuous groove or opening44created by pushing distal seam42connected to access system50towards folded line34. It should be noted that even though access system50is embedded with enclosure32, access system50remains external to the enclosure. Only portion40bof string40is actually inside enclosure32.

Referring now toFIG. 5A, one embodiment of a completed dual chamber bag according to the principals of the present disclosure is illustrated by bag30. A peel seal56ais made to separate enclosure32into first fluid chamber58aand second fluid chamber58b. One suitable apparatus and method for forming the peel seal or frangible seal56ais 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 portion40bof string or handle40is embedded within and extends through peel seal56a. In this way, when the patient or caregiver pulls string or handle40, inner portion40bis configured and positioned to tear peel seal56aand allow a first fluid residing within first fluid chamber58ato mix with a second fluid residing within a second fluid chamber58b.

Access system50is relatively inaccessible to the patient or caregiver before that person pulls string or handle40to tear frangible seal56aand expose access system50. It is possible however that if someone labored hard enough, they could locate access system50within the folds creating opening44and puncture seal54before pulling string or handle40. Accordingly, and optionally, a second frangible seal56bis provided at the open end of opening44, which seals that open end until handle40is pulled, tearing second frangible seal56b. Here, second peel seal56bcan be fixed or fastened to handle40, such that it is carried with handle40as exposed section40aof handle40is pulled. As seen inFIG. 5B, second frangible seal56bdoes not have to fully close the open end of opening44but merely make reaching access system50impossible or at least highly improbable and impractical.

Referring now toFIG. 5B, an alternative version of dual chamber bag30is illustrated. Dual chamber bag30ofFIG. 5Bis like dual chamber bag30ofFIGS. 1 to 5Ain all respect except that inner portion40bof handle40includes multiple string loops or is otherwise expanded such that when exposed portion40aof handle or string40is pulled, the multiple loops or expanded version of inner portion40btears open a larger portion of peel seal56a, increasing the ability of first and second fluids located within first and second chambers58aand58bto mix properly and efficiently.

Referring now toFIGS. 6 to 9, a second primary embodiment of the dual chamber solution bag according to the present disclosure is illustrated by bag60(FIG. 9).FIGS. 6 to 8show various stages of manufacturer of bag60.FIG. 9shows one embodiment for completed bag60.FIG. 10shows another embodiment for dual chamber bag60.

One primary difference between bag60and bag30ofFIGS. 5A and 5Bis that the pull string of bag30is replaced by handle70, which in the illustrated embodiment is a piece of plastic film or sheeting, such as the same sheeting used to form enclosure62. Enclosure62also has a different shape than enclosure32of bag30. Another primary difference for dual chamber bag60is that enclosure62is folded at the bottom of the bag, near handle70, and is welded at opposing upper seam64. As seen inFIGS. 6 to 9, sheet handle70includes an outer pull portion70a, which resides outside chamber62, and which defines an aperture82sized for example to accept a finger or fingers of the patient or caregiver. Handle70also expands in size at an inner portion70b, which is maintained within enclosure62. The larger portion70bis sized to open all or most all of a frangible or peel seal when the patient or caregiver grasps and pulls handle80.

FIG. 7illustrates that enclosure62is formed by folding the enclosure at fold line72a, such that upper seam64, and side seams66a,66b,68aand68bcan be welded via any of the embodiments discussed herein. Also, enclosure62is welded at seams72band72cdiscussed in further detail below.FIG. 7further illustrates how sheeting handle70is integrated into enclosure62, namely, it is inserted near the bottom of enclosure62, so that a curved edge84of handle70comes into substantial alignment with curved seam68aof enclosure62.

FIG. 8illustrates a sealed enclosure62prior to the enclosure being folded into itself to protect against inadvertent breaking of seal54of access system50. Here, handle70is sealed within enclosure62, such that portion70bresides within enclosure72and portion70aremains outside of enclosure72. Enclosure62is welded at seams64,66a,66b,68a,68band72b. The upper end of enclosed portion70bof handle70expands at an area where a first frangible or peel seal is made as seen inFIG. 9.

Seal68bdoes not include the side of the portion70bof handle70. That is, sides of enclosure62are welded together to form68b. Likewise, seal68adoes not include edge84of handle70. Seal72bhowever does include handle70. In this manner, enclosure62at seal72bmoves with handle70as handle70is grasped and pulled, which in turn moves inner portion70bof handle70relative to seals68aand68b.

FIG. 9shows a completed dual chamber bag60. Here, enclosure62is folded within itself to form inner opening74, which includes a continuous opening around an inner opening wall78and outer opening wall76of enclosure62. Enclosure62is folded into itself until access system50is hidden within enclosure62.

First and second frangible seals56aand56bare then applied to enclosure62. Frangible seal56aseals sheets of enclosure62and an upper end80of handle70. Upper end80spans substantially all of the width of enclosure62, such that seal56aopens a large area for solution A housed in first chamber88ato mix properly and readily with solution B maintained within chamber88b. As illustrated, frangible seal56aseparates chamber88afrom chamber88b.

A second frangible seal56bis provided to separate solution B of chamber88bfrom an access area and from reaching access system50. When the patient or caregiver pulls handle70, e.g., via opening82, inner portion70btears through frangible seals56aand56bvirtually simultaneously, so that solutions A and B mix and also so that the mixed solution reaches seal54of access system50for the first time. Thus, even if the patient breaks access system seal54prior to opening peel seals56aor56b, no single solution can reach the patient. Alternatively, portion70bis welded with seams68aand68b, and seal56bis broken by applying pressure to the outside of enclosure62after frangible seal56ais broken.

It is possible with bag70that frangible seal56bcould be broken before frangible seal56ais broken, enabling only solution B to reach access assembly seal54. If the patient or caregiver then breaks frangible seal54, solution B alone could reach the patient. To remedy the above,FIG. 9illustrates an alternative embodiment for dual chamber bag60, in which access system50is rotated ninety degrees with respect to its position in bag60ofFIG. 9. In dual chamber bag60ofFIG. 10, access system50is very difficult to locate and open until handle70is pulled and both frangible seals56aand56bare broken. The configuration of access system50inFIG. 10adds another layer of security and safety to dual chamber bag60.

Referring now toFIGS. 11A to 11C,12A,12B,13A,13B,14A,14B,15A,15B,16A,16B,17A,17B,18A,18B,19A,19B and20A to20C a yet further alternative dual chamber bag of the present disclosure and method of making same is illustrated by bag90(FIGS. 20A to 20C).FIGS. 11A to 11Cshow three different configurations for enclosure92of dual chamber bag90.FIG. 11Aillustrates an enclosure92having a stepped shaped bottom.FIG. 11Billustrates enclosure92having a triangular shaped bottom.FIG. 11Cillustrates enclosure92having a rounded bottom. For purposes of illustration, the stepped shaped bottom ofFIG. 11Ais 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 enclosure92ofFIGS. 11A to 11Cand to other suitable shapes that may be readily formed by those of skill in the art.

FIGS. 12A and 12Bshow that the first step in the manufacturer of dual chamber bag90is to fold enclosure92at fold line94.FIGS. 13A and 13Billustrate that the next step includes the formation of welded seams96aand96balong a portion of the sides of enclosure92. Also, access system50is welded to enclosure92at fold line94. Further, a handle100, such as a loop or tab, is welded to the outside of enclosure92.

FIGS. 14A and 14Billustrate the addition of the first frangible seal56a, which separates access system50from the remainder of enclosure92. Air is maintained between frangible seal56aand access system50.FIGS. 15A and 15Billustrate a second folding operation resulting in second fold lines98and the creation of channel102between the access system50and handle100area and the outer sheets of enclosure92.

Referring now toFIGS. 16A and 16B, another step in the manufacturer of dual chamber bag90is the addition of welded seams104aand104b, which further enclose chamber102.FIG. 16Bshows how weld104bis made around inner weld96b.FIGS. 17A and 17Billustrate a third folding operation, in which fold lines106are created by folding enclosure92at a portion of weld seams104aand104b. The additional fold creates an outer chamber108, which surrounds inner chamber102.

FIGS. 18A and 18Billustrate the addition of outer welds110a,110band112. Outer welds seal outer chamber108completely.FIGS. 19A and 19Billustrate the addition of the second peel seal or frangible seal56b. The second frangible seal56bis made to divide outer chamber108into first fluid holding chamber114aand second fluid holding chamber114bas seen best inFIG. 19B. Frangible seal56aseals access system50from chamber114aas seen inFIG. 19B.

FIGS. 20B and 20Cillustrate dual chamber bag90in further detail.FIG. 20Bis a section view ofFIG. 19Ataken along line XX-XX shown inFIG. 19A.FIG. 20Bshows the general shape of first chamber114aand second chamber114b. It also shows that frangible seals56aand56bare aligned and overlapping. Second chamber114bis an annular or continuous chamber in which a second solution is trapped between outer and inner cylindrical or continuous walls. Second chamber114bsurrounds an empty space in which access system50and handle100are located.

When the user pulls handle100, peel seal56bbetween chambers114aand114bis subjected to a force almost perpendicular to the walls of container90, due to the folding of film of enclosure92. In contrast, frangible seal56ain 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 seal56aseparating chambers114aand114bbreaks before inner frangible seal56a, guaranteeing that mixing takes place before any liquid can reach seal54of access system50. In the illustrated embodiment, frangible seal56bis broken by applying pressure to the mixed open chambers, such that the increased pressure of the liquid causes frangible seal56ato open and fluid to flow to access system50.

FIGS. 21 to 23illustrate still a further alternative dual chamber bag120and method of making same, which includes the provision of a vertical frangible seal after access system50is pushed as far as it can go into enclosure122.FIG. 22shows that enclosure122at access system50is pushed into itself until that portion meets upper distal wall124of enclosure122. String40in enclosure120is maintained wholly outside of enclosure122and indeed can be welded to the outside of enclosure122. Access system50is welded at seam126to upper edge124of enclosure122.

FIG. 23illustrates that upper and lower frangible seals56aand56b(located one on top of the other) separate and form first and second chambers128aand128b. When the user pulls cord40, access system50is pulled through both upper and lower frangible seals56aand56b, allowing first and second fluids in first and second chambers128aand128b, respectively, to mix. It should be appreciated that even if the user some how punctures seal54of access system50prior to pulling access system50through first and second frangible seals56aand56b, weld126seals first and second chambers128aand128bfrom access system50, such that no fluid can be transferred to the patient.

FIGS. 24 to 26illustrate another vertical frangible seal embodiment. This embodiment includes three frangible seals56a,56band56c. Dual chamber container130includes an enclosure132formed in much the same way as is enclosure92of container90discussed above. Here, first seal56aforms a safety seal between enclosure132and access system50. Thus even if the patient or user breaks seal54of access system50prior to vertical frangible seals56band56cbeing broken, frangible seal56aisolates access system50from enclosure132. Vertical peel seals56band56cas seen inFIGS. 24 and 26separate enclosure132into first and second fluid carrying chambers134aand134b. The user pulls handle or cord40, which is completely external to chamber132to rip an upper inner edge136of enclosure132through frangible seals56band56c, allowing fluid from first and second chambers134aand134bto mix.

It should be appreciated that many of the dual chamber containers described herein, such as container130can be opened readily for example by hanging cord40around a door handle and allowing enclosure132, holding first and second fluids to drop hangman style to automatically mix the first and second fluids. Here, access system50points vertically upward (imagine container130inFIG. 25turned upside down), such that the weight of fluid will not place any pressure on safety frangible seal56a. The user can then squeeze dual chamber container130to pop or open frangible seal56a.