WO2000003674A1

WO2000003674A1 - Pouch for retaining and administering medical fluids

Info

Publication number: WO2000003674A1
Application number: PCT/EP1999/004950
Authority: WO
Inventors: William Creveling Christine
Original assignee: Novartis Nutrition Ag
Priority date: 1998-07-15
Filing date: 1999-07-13
Publication date: 2000-01-27
Also published as: AU4910599A

Abstract

A pouch for administering medical fluids is defined by planar front and rear walls which are heat sealed to one another around their peripheries and which define a reservoir for retaining fluids therein. A fitment is positioned at one end of the reservoir. The fitment is heat sealed between the front and rear walls. The fitment includes a boat shaped body portion and a projecting shaft. A central conduit is formed through the body portion and the shaft and communicates with the reservoir formed by the pouch. The central shaft includes a breakaway tip at one end, opposite of the body portion. The breakaway tip closes the conduit at the projected end and, upon breaking the tip away from the shaft end, opens the conduit. An external thread may be provided for attaching a standard medical fluid administration set and forming a fluid passage from the reservoir. The body of the fitment has a series of ribs projecting from the outer periphery. A web is formed between the ribs at the projecting tapered edges of the body. The web serves to comingle with the material of the pouch during heat sealing to form a seal at the edges of the fitment body.

Description

POUCH FOR RETAINING AND ADMINISTERING MEDICAL FLUIDS

Field of the Invention The present invention relates to a pouch for retaining fluids therein and, in particular, a pouch for the administering medical and/or nutritional fluids to a patient. The pouch comprises various elements for adding and removing fluids from the reservoir formed by the pouch, including a fitment secured between the walls of the pouch for connecting to a medical and/or nutritional fluid administration set and a diluent port for adding fluids to the reservoir.

Background of the Invention

Medical fluid pouches or drip-feed bags often include a fitment located at one edge of the bag. The fitment is hermetically sealed between the webs or sidewalls of the pouch. Often it is difficult to form the seal where the two webs join the fitment.

It is known to use a boat-shaped molded fitment having a central thickened area and tapered opposing edges. The tapering of the edges is intended to assist in sealing the fitment between the walls of the pouch during the heat sealing operation. However, in certain situations, the sealing of the fitment to the pouch is insufficient to form an adequate seal. The present invention relates to the formation of a more appropriate seal and the form of the fitment.

Brief Summary of the Invention The present invention relates to a pouch for retaining and administering fluids and preferably comprises front and rear walls that are heat sealed to one another around their periphery and which define a reservoir for retaining fluid therein. A fitment is positioned at one end of the reservoir and heat sealed between the walls when defining the reservoir. The fitment includes a body portion which is sealed between the front and rear walls and a shaft projecting outwardly. A central conduit is formed through the body portion and the shaft and communicates with the reservoir. Additionally, an external thread or other attachment means may be used for securing a standard medical/nutritional fluid administration set to the shaft for fluid communication with the conduit. In one embodiment, the pouch incorporates a fitment having a body portion which presents a lenticular or boat shape having tapered sides forming side edges and including a series of spaced ribs on the outer periphery thereof. A thin web or flashing projects outwardly from the edges of the body portion between the ribs. The web, upon heat sealing the fitment between the front and rear walls of the pouch, melts along with the front and rear wall portions such that the materials co-mingle and form a hermetic seal at the edges of the fitment body.

In another embodiment, the fitment includes a compression coil spring contained longitudinally in the central conduit. A ball having a diameter approximately equal to the spring is housed in the central conduit. The spring urges the ball into engagement with a radially tapered wall within the shaft. A cap having an annular body portion with an inside diameter greater than an outside diameter of the fitment shaft and having a shaft extending from the cap body portion may be attached to the fitment for releasing the fluids from the pouch and communicating with a fluid administration set. A central conduit is formed through the cap body portion and cap shaft. The cap further includes a post extending along the longitudinal axis of the cap from the shaft into the body portion where the cap engages and surrounds the fitment, such that the post engages the ball and forces the ball towards the reservoir, opening the fluid passage.

In another embodiment, the pouch incorporates at least one port sealed to an inside surface of one of the walls of the reservoir, with the pouch material covering a port inlet. The port comprises at least one generally cylindrical shaft extending into the reservoir and an end wall extending across the shaft. The shaft has at least one opening which is transverse to the axis of the shaft. A sealing material is positioned within the shaft. An additive material for the fluid in the reservoir of the pouch is added to through the port. A needle is inserted into the port, through the wall of the pouch and through the sealing material. The end wall prevents further penetration and the additive is permitted to flow into the reservoir through the transverse opening.

The various features of the embodiments of the invention may be incorporated together or may be utilized separately, depending on the needs and desires of the consumer for the pouch. Brief Description of the Drawings

For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown.

Figure 1 shows a front plan view of a pouch having a fitment and port in accordance with the present invention.

Figure 2 shows a isometric view of a fitment as contemplated by the present invention. Figure 3 shows a cross sectional view of the fitment as taken along line 3-3 in Figure 1.

Figure 4 shows a cross section of the fitment body portion as taken along line 4-4 in Figure

2.

Figure 5 shows a further cross section of the fitment as taken along line 5-5 in Figure 2.

Figure 6 shows a exploded isometric view of another embodiment of a fitment, including a cap, as contemplated by the present invention.

Figure 7 shows a cross sectional view of the fitment as taken along line 7-7 of Figure 6. Figure 8 shows a cross sectional view of the fitment as taken along line 8-8 of Figure 7. Figure 9 shows a cross sectional view of the fitment of Figure 6 illustrating the cap engaged with the fitment.

Figure 10 is a cross sectional view of the fitment and the cap taken along line 10-10 of Figure 9.

Figure 11 is a cross sectional view of the fitment and the cap taken along line 11 -11 of Figure 9.

Figure 12 shows an isometric view of a port as contemplated by the present invention. Figure 13 shows a cross section view of the port as taken along line 13-13 in Figure 1. Figure 14 shows a further cross section of the port as taken along line 14-14 in Figure 13.

Detailed Description of the Invention

In the drawings, where like numerals indicate like elements, there is shown an embodiment of a pouch which is generally referred to by the numeral 10. The pouch 10 includes a fitment 12 at one end. The pouch 10 is formed by a front wall 14, which is a generally planar sheet of flexible plastic, and a generally planar rear wall 16 (which is illustrated in part in Figure 4). The planar front and rear walls 14, 16 are positioned parallel to one another and are heat sealed along their peripheries to form a reservoir therebetween. The heat seals include side seals 18 and 20, bottom seal 22 and top seal 24. The fitment 12 is positioned between the front wall 14 and rear wall 16 and is secured thereto by the bottom seal 22.

In the formation of the pouch 10, the front wall 14 and rear wall 16 are positioned adjacent one another and the heat seals 18, 20 and 22 are formed, with the fitment positioned therebetween. The medical and/or nutritional fluids are then introduced into the reservoir formed between the front and rear walls and the top seal 24 then seals the fluids therein.

Preferably, this operation is performed in an aseptic environment. Projecting above the top seal 24 are tabs 26 which include a slot or opening 28 therein. The slot 28 forms a means for hanging the pouch 10 so that the medical/nutritional fluids therein can be administered to a patient. Other forms of hanging means are known in the art and are contemplated for use with the present invention.

As illustrated in Figure 2, the fitment 12 includes an upper body portion 30 and a central projecting shaft 32. A central conduit 36 is formed through the body portion 30 and the shaft 32, as illustrated in Figures 3 and 5. A frangible tab 34 is formed at the end of the shaft 32 and closes the conduit 36. Gripping tabs 38 project outwardly from the shaft 32 on opposite sides. An external thread 40 is provided on the outer surface of the shaft 32 adjacent its end, above the position of the frangible tab 34. The external thread 40 forms a means for connecting the shaft 32 to a standard medical/nutritional fluid administration set (not shown) so that the fluids within the reservoir formed by the pouch 10 may be administered to a patient.

As illustrated in Figure 3, the fitment 12 is secured to the front wall 14 and rear wall 16 at the body portion 30. The body portion 30 includes a series of projecting ribs 42 that extend around the periphery of the body portion 30. As more particularly illustrated in Figures 2 and 4, the body portion 30 has a generally boat shaped cross section. Adjacent the central conduit 36 is a central thickened area 44. The body portion 30 tapers to a point 46 on each side of the central thickened area 44. The projecting ribs 42 wrap around the surface of the body portion 30 and project from the tapered edges formed at the points 46. As can be seen from Figures 2-5, the ribs 42 are preferably tapered in their projection from the body 30. Positioned between the ribs 42 at the points 46 of the body portion are a series of webs 48. The webs 48, as more particularly shown in Figure 5, are thin projections formed between the ribs 42 which, when heat sealing the fitment 12 between the front wall 14 and rear wall 16 of the pouch 10, melt along with the pouch material, comingling with the pouch material, and form a hermetic seal at the tapered edges 46 of the fitment body 30. The webs 48 positioned between the projecting ribs 42 at the tapered edges 46 of the body portion 30 assure the softening (melting) of the polymers. The walls of the pouch comingle with the fitment polymers 42 to seal the fitment within the walls 14, 16 of the pouch 10.

The webs 48 may be formed by polishing the tool that forms the fitment between the area of the ribs so that the pressure within the mold causes flashing in the polished area. The flashing creates a thin web of polymer that will respond to the energy of the heat and pressure effect when the bottom seal 22 is formed on the pouch 10. The webs are preferably of a larger cross section at their base and attachment with the body portion of the fitment and taper in cross section on the the outward direction. The preferred dimension for the base of the tapered section for the webs falls in the range of 0.38 to 0.5 millimeters for a fitment that is approximately 17 millimeters in width. The preferred dimension for the tip of the tapered web is in the range of 0.05 to 0.13 millimeters for the same size fitment. The ribs would be of a greater dimension at the base. The ribs and webs preferably project about the same amount from the tapered edges of the body portion. For the above dimensions, the ribs and webs preferably project approximately 1.0 millimeters from the body portion.

The ribs 42 around the fitment 12 further enhance the seal. As shown in Figures 3 and 4, the walls 14, 16 of the pouch wrap around the ribs 42 and define a tortuous path along the outside surface of the body 30 of the fitment 12. In addition, the ribs serve as energy directors during the sealing process. The fitment is typically made of a material that is harder than the material of the pouch, having a higher melting temperature. In addition, the body of the fitment has a greater mass than the portion of the walls of the pouch that is in contact with the heater element. In the typical situation, the walls of the pouch will heat and melt faster than the sides of the fitment. This creates a possible breach in the pouch material prior to completion of the seal with the fitment. To avoid this possibility, the sealing temperatures and contact times are reduced. However, an insufficient seal may then be formed. By providing energy directors in the form of ribs, the flat sealing element can press the film against the relatively low mass of the ribs and form a series of individual seals with the rib material which will melt much quicker than the remainder of the body of the fitment. The tab 34 seals the end of the shaft 32 and maintains the fluids within the reservoir of the pouch 10. A groove 50 is provided in the shaft 32, below the threads 40. The groove 50 serves to weaken the shaft such that a flexing of the tab 34 can occur to break the tab from the shaft and open the conduit 36. The side tabs 38 provide a gripping point for the shaft when flexing the tab to break it off of the shaft. Once the tab 34 is removed, the fluid administration set can be attached to the threads 40 at the end of the shaft 32. Another embodiment of the fitment is illustrated in Figures 6 through 1 1. This second fitment embodiment is generally designated as 12. As shown in Figure 7, the fitment 12 includes a coil spring 51 contained in the central conduit 36 along a longitudinal axis. The spring 51 abuts against inwardly extending tabs 52 at an upper end 53 of the spring 51. The tabs 52 maintain the upper end 53 of the spring 51 in a generally stationary position relative to the body portion 30. A ball 54 is retained in the central conduit 36 by spring 51. The ball 54 is engaged by a second end 55 of spring 51. The ball 54 and the spring 51 have an outside diameter less than the inside diameter of the central conduit 36. Shaft 32 has a tapered wall 56 at its lower end that extends radially inward and downward. The spring 51 engages and urges ball 54 into sealing contact with the tapered wall 56. A frangible tab 34 is provided on the end of the shaft 32, and closes the end of the shaft similar to tab 24 on fitment 12 shown in Figures 1 -5.

In order to place the spring 51 into the central conduit 36', the tabs 52 are initially generally parallel with the central conduit 36' longitudinal axis. Once the spring 51 is placed into the central conduit 36', the spring 51 is slightly compressed and the tabs 52 are bent into engagement with the spring 51. The tabs 52 are bent by, for example, slightly heating the material of the tabs 52 so that they become flexible. Once the tabs 52 achieve the desired position, they are allowed to cool thereby maintaining the position illustrated in Figure 9. As shown in Figures 6 and 9, a fluid release cap 58 is provided for engaging fitment 12 in order to allow the free flow of fluid from the pouch to an administration set (not shown). In order to place the fluid release cap 58 onto the fitment 12 the tab 34 is removed, as shown in phantom in Figure 6. Once the tab 34 has been removed, the cap may be placed about the shaft 32 of fitment 12, as illustrated in cross section in Figure 9. The cap includes a generally annular body portion 60 and a shaft 62 extending away from fitment 12. A central conduit 64 is formed through the body portion 60 and the shaft 62. The cap 58 also includes a post 66 extending along a longitudinal axis of the cap 58. The post starts within the shaft 62 and extends upwardly into the body portion 60.

Operationally, when the cap 58 is placed onto the fitment 12 the post 66 engages the ball 54 and, as the cap 58 is further pressed into engagement with the fitment 12, the post 66 urges the ball 54 away from the tapered wall 56. As the ball 54 is removed from the tapered wall 56 fluid in the reservoir will be allowed to flow through the central conduit 36, past the ball 54, down through the central conduit 64, through the cap opening 67 and into an administration set.

The fitment 12 includes retaining pins 68 extending radially outward from the exterior wall of the shaft 32. The cap 58 includes corresponding J-channels 70 for receiving the retaining pins 68. The J-channels 70 are located on the cap body portion 60. Operationally, when the cap 58 is placed onto the fitment 12 the retaining pins 68 slide into the J-channel until reaching the bottom of the channel. Once the pins 68 have reached the bottom of the channel 70 the cap 58 is twisted, allowing the pins 68 to rotate into the hook portion of the J-channel 70. Once the cap 58 is released, the force of the spring 51 will cause the retaining pins to engage the upper wail of the hook portion, thereby holding the cap 58 in place.

The cap 58 further includes ribs 72 extending vertically along the outside wall of cap body portion 68 and the cap shaft 62. The ribs 72 engage an administration set line and hold such a line in place.

The present invention is contemplated to include other forms and arrangements. In particular, the boat shaped fitment may have surfaces which are generally planar towards the projected edges 46 or may be curved in the formation thereof. In addition, the ribs on the fitment may be excluded, if desired. Further, the formation of the seal at the end of the shaft may be other than the formation of the breakaway tip as presently contemplated. Also, means may be provided to close the end of the shaft 32 and the conduit 36 therein. A number of closures are know in the art, including frangible or break away tips, so that the fluids may be stored with the pouch. Also, means may be provided to maintain the projected shaft within a sealed environment which may be opened at the time of its connection to the fluid administration set.

Another element of the present invention is a fluid input or a diluent port 74 and is illustrated in Figures 1 and 12-14. The port 74 is coupled to the inside surface of the pouch wall 14 by a coupling face plate 80. The face plate 80 includes two openings 75 and 77. First and second port receptacles 76 and 78 extend into the pouch from the face plate at the two openings 75, 77. The receptacles 76, 78 are generally annular shaped cylinders. The face plate 80 and the receptacles 76, 78 are preferably formed of a single piece of plastic. The receptacles 76,78 each include an end wall 82, 84, respectively, positioned transverse to their longitudinal axes. An opening 86, 88 is provided proximal to the end walls 82, 84, respectively. Each receptacle contains an elastomeric material membrane 90, 92, respectively, which is self-healing when punctured. The membranes are mounted transversely in each receptacle 76, 78 between the pouch wall 14 and the openings 86, 88, respectively.

Operationally, fluids may be added to the reservoir by inserting a needle through the pouch wall 14 and the elastomeric membrane 90, for example. Once the needle tip has penetrated the elastomeric membrane 90 a plunger may be depressed thereby adding fluid to the receptacle. Fluid travels through the opening 86 and comingles with fluid in the reservoir. The end walls 82, 84 serve to prevent a needle from advancing too far into the pouch and puncturing the opposite wall 16. Once the fluid has been injected into the pouch 10, the needle is removed and the membrane 90 will seal itself. Self sealing membrane material is known in the art.

The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, referenced should be made to the appended claims, rather than to the foregoing specification, as indicating the scope of the invention.

Claims

1. A pouch for administering medical and/or nutritional fluids, the pouch comprising:

a front wall and a rear wall, the front and rear walls heat sealed to one another around their peripheries and defining a reservoir for retaining fluids,

a fitment positioned at one end of the reservoir, the fitment heat sealed between the front and rear walls during the formation of the reservoir, the fitment comprising

a boat shaped body portion,

a shaft projecting from the body portion outwardly from the reservoir,

a central conduit formed through the body portion and the shaft and communicating with the reservoir,

means for securing an administration set to the shaft and for communicating with the conduit,

web means projecting outwardly from the tapered edges of the body portion for comingling with the material of the front and rear wall upon heat sealing of the fitment between the front and rear walls during the formation of the pouch.

A pouch as claimed in claim 1 further comprising:

a fluid input port positioned proximal to another end of the reservoir, the port hermetically sealed to the inside surface of the pouch, wherein the pouch material covers a port inlet, the port comprising

at least one generally cylindrical shaft extending into the reservoir, an end wall at an internal end of the shaft, and

at least one opening in the shaft for passing fluid to the reservoir.

3. A pouch as claimed in claim 2, wherein the fluid input port comprises

a pair of generally parallel cylindrical shafts extending into the reservoir,

an end wall at an internal end of each shaft,

at least one opening in the shaft for passing fluid to the reservoir.

4. A pouch as claimed in claim 3, wherein the port further comprises an elastomeric material transversely mounted in the shaft between the at least one opening and the port inlet.

5. A pouch as claimed in claim 2, wherein the port further comprises a coupling plate connected to the at least one shaft for coupling and sealing the shaft to the pouch.

6. A pouch as claimed in claim 1 , wherein the body portion includes a series of spaced ribs projecting from the outer periphery thereof, the web means projecting outwardly from the tapered edges of the body portion between the ribs.

7. A pouch as claimed in claim 1 , wherein the fluid administration set securing means comprises an external thread on the shaft adjacent the end of the shaft.

8. A pouch as claimed in claim 1 , wherein the fitment further comprises:

a compression coil spring contained longitudinally in the central conduit, wherein an outside diameter of the spring is less than the inside diameter of the central conduit, a plurality of tabs extending radially inward from the central conduit, abutting and maintaining an end of the spring proximate to the reservoir, a ball housed in the central conduit, having a diameter approximately equal to the spring,

wherein the shaft includes a wall tapering radially inward and away from the reservoir presenting a diameter less than the ball, wherein the spring urges the ball into engagement with the tapered wall.

9. A pouch as claimed in 8, wherein the means for securing an administration set to the shaft and communicating with the conduit comprises:

a cap comprising

a generally annular body portion having an inside diameter greater than an outside diameter of the fitment shaft,

a shaft extending from the cap body portion,

a central conduit formed through the cap body portion and the cap shaft,

a post extending along the longitudinal axis of the cap from the cap shaft into the cap body portion,

wherein the cap engages and surrounds the fitment shaft such that the post engages the ball, forcing the ball towards the reservoir.

10. A fitment for use with a pouch for retaining fluids, the pouch including a front and rear wall which are heat sealed to one another and the fitment being sealed between the front and rear walls during the formation of the pouch, the fitment comprising:

a body portion, the body portion having a central thickened area and two opposing projecting tapers forming edges of the body portion, a shaft projecting outwardly from the body portion,

a central conduit formed through the body portion and the shaft,

a series of spaced ribs projecting from the outer periphery of the body portion, and

a series of webs projecting outwardly from the tapered edges of the body portion and extending between the ribs at the tapered edges.

1 1. A fitment for use with a pouch for retaining medical and/or nutritional fluids, the pouch being formed by heat sealing a front and rear wall around their peripheries to form a fluid reservoir therebetween, the fitment comprising:

a body portion, the body portion defining a central conduit and two opposing tapered side edges,

a shaft projecting outwardly from the body portion with the conduit extending through the shaft,

a frangible tab removably positioned on the end of the shaft, the tab sealing the conduit and preventing exposure of the conduit interior prior to removal of the tab, and

webs projecting outwardly from the tapered edges of the body.

12. The fitment as claimed in claim 11 , further comprising a series of spaced ribs on the outer periphery of the body portion.

13. The fitment as claimed in claim 12, wherein the ribs extend around the tapered edges and wherein the webs extend between the ribs.

14. A fitment for use with a pouch for retaining fluids, the pouch including a front and rear wall which are heat sealed to one another and the fitment being sealed between the front and rear walls during the formation of the pouch, the fitment comprising:

a body portion, the body portion having a central thickened area and two opposing projecting tapers forming edges of the body portion,

a shaft projecting outwardly from the body portion,

a central conduit formed through the body portion and the shaft,

a compression coil spring contained longitudinally in the central conduit, wherein an outside diameter of the spring is less than the inside diameter of the central conduit,

a plurality of tabs extending radially inward from the central conduit, abutting and maintaining an end of the spring proximate to the reservoir,

a ball housed in the central conduit having a diameter at least approximately equal to the diameter of the spring,

15. A fitment as claimed in claim 14 further comprising:

16. A pouch for administering medical and/or nutritional fluids, the pouch comprising:

a closable fitment for selectively directing fluid from the reservoir,

a fluid input port positioned proximate to another end of the reservoir, the port hermetically sealed to the inside surface of the pouch, wherein the pouch material covers a port inlet, the port comprising

at least one generally cylindrical shaft extending into the reservoir,

an end wall at an internal end of the shaft, and

at least one opening in the shaft for passing fluid to the reservoir.

17. A pouch as claimed in claim 16, wherein the fluid input port comprises:

a pair of generally parallel cylindrical shafts extending into the reservoir,

an end wall at an internal end of each shaft,

at least one opening in the shaft for passing fluid to the reservoir.

18. A pouch as claimed in claim 16, wherein the port further comprises an elastomeric material transversely mounted in the shaft between the at least one opening and the port inlet.

19. A pouch as claimed in claim 16, wherein the input port further comprises a coupling plate connected to the at least one shaft for coupling and sealing the shaft to the pouch.

20. A pouch as claimed in claim 16 wherein the fitment comprises:

a body portion, the body portion having a central thickened area and two opposing projecting tapers forming edges of the body portion

a shaft projecting outwardly from the body portion,

a central conduit formed through the body portion and the shaft,

a series of webs projecting outwardly from the tapered edges of the body and extending between the ribs at the tapered edges.

21. A pouch as claimed in claim 16 wherein the central conduit of the fitment comprises a removable closing tab at its projected end, the tab sealing the conduit and preventing exposure of the conduit interior to the ambient atmosphere prior to removal of the tab.

22. A pouch as claimed in claim 16 wherein the fitment comprises:

a compression coil spring contained longitudinally in the central conduit, wherein an outside diameter of the spring is less than the inside diameter of the central conduit

a ball housed in the central conduit, having a diameter approximately equal to the spring, wherein the shaft includes a wall tapering radially inward and away from the reservoir presenting a diameter less than the ball, wherein the spring urges the ball into engagement with the tapered wall.