Abstract:
An adapter utilized to interconnect a fluid container and a tubing set having a retractable spike and a rolling seal diaphragm for establishing fluid flow communication between a nutrition container and an administration tubing set while maintaining a fluid-tight seal. The rolling seal diaphragm includes a rolling seal portion which sealingly engages the retractable spike which remains engaged with the spike while the spike is biased between an engaged position and a disengaged position.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention generally relates to an adapter for interconnecting a fluid container with an administrative tubing set, and more particularly to an adapter having a retractable spike for use with a feed assembly. More specifically, the present invention relates to an adapter having a retractable spike and a rolling seal diaphragm arrangement for establishing fluid flow communication between a fluid container and an administration tubing set while maintaining a fluid-tight seal therebetween. 
     2. Prior Art 
     Feeding systems are frequently used to provide nutrition through either enteral or parenteral access to a patient unable to take nutrition orally. As used herein, the term nutrition shall be interpreted to include nutrition, medication and hydration. These feeding systems typically comprise an administration tubing set attached to a source of nutrition at one end and some kind of tube arrangement at the other end for providing nutrition immediately to a patient. In enteral feeding, the nutrition is typically administered to the patient by accessing a digestive organ through use of a nasogastric or gastrostomy tube which terminates in the stomach or a nasojejunal or jujunostomy tube which terminates in the jejunum. In contrast, parenteral feeding typically includes feeding nutrition by injection into a vein. Feeding systems also include fluid containers, which hold nutritional fluid in liquid form and typically include an opening sealed with a flexible membrane to seal and isolate the contents from environmental contaminates. 
     Often fluid containers of the above-mentioned character are connected to the administration tubing set by an adapter. One such adapter typical of the prior art is disclosed in U.S. Pat. No. 4,567,999 to Hjertman et al. entitled “Self-adhesive Connecting Device.” Hjertman discloses an adapter for providing a sealed liquid connection with the orifice of a fluid container formed from a flexible sheet material. The adapter includes a hollow chamber with an outside surface adapted to be adhered to the container wall and a sharp point that is encased therein which is operative to penetrate the wall of the container. A pressure sensitive adhesive is provided on the outer peripheral surface of the Hjertman adapter that is intended to attach the adapter to the container wall such that the hollow chamber is sealed from outside contaminates. 
     Although the device of Hjertman et al. effectively provides a sealed liquid connection with a container, such devices also have several inherent drawbacks. Because the device to Hjertman entirely encloses the sharp point within the chamber, the user of these devices would need to apply a sufficiently strong exterior force to the chamber in order to actuate the device. However, directly exerting an exterior force upon the chamber to actuate the device increases the possibility of rupturing the chamber and resulting in mechanical failure of the device. Moreover, inadvertent impacts upon the chamber during transportation and storage are also likely to result in premature rupturing of the chamber. Finally, properly adhered to the container, such devices can not be easily reused with other fluid containers. 
     Other connection devices have been suggested to further advance the art. For instance, U.S. Pat. No. 5,041,105 to D&#39;Alo et al. entitled “Vented Spike Connection Component,” which is assigned to the assignee of the present invention, discloses a connection component suitable for use with a feeding set which includes a fluid container having a cap with an orifice and external threading disposed about the cap. A foil, or other similar frangible material, seals off the orifice of the container from fluid flow and outside contaminants. The connection component includes internal threading which mates with the external threading of the cap and a projecting spike which is adapted to penetrate the foil seal and establish fluid flow as the connection component is attached to the fluid container and actuated. 
     Although the D&#39;Alo et al. device substantially advances the art, such connection components could still be further improved upon. The device to D&#39;Alo et al. relies solely on frictional engagement between the threaded portion of the housing body and the threaded portion of the cap to create and maintain a fluid-tight seal. The device to D&#39;Alo et al. also operates to simultaneously pierce the container when the user connects the connection component, and thus the operator must interconnect the device at the precise moment when it is desired to establish fluid flow. In other words, the operator can not attach the D&#39;Alo et al. device to the pre-filled container without instantaneously piercing the foil seal and establishing fluid flow which may be undesirable. The operator must delay attaching the device to the container until needed, or the operator must attach the device to the fluid container and immediately establish fluid flow when the foil seal is pierced by the device connection. 
     Therefore, one skilled in the art can best appreciate that several advances would still be desirable. It would be desirable to have a connection device that may be properly secured to the container, while allowing the operator to delay piercing the fluid container and establish fluid flow when needed. It would also be desirable to have a connection device which provides a leak-free seal at all times between the fluid container, the connection device, and the administration tubing set. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     In brief summary, the present invention overcomes and substantially alleviates the deficiencies in the prior art by providing an adapter that provides a rolling seal diaphragm which provides a leak-free connection site. The adapter operates as a connector between a fluid container and an administration tubing set with the fluid container having a cap that has an orifice and an external threading disposed about the cap. A foil, or other frangible membrane, seals off the orifice of the container from fluid flow prior to use. The administration tubing set includes hollow tubing which interconnects a tube arrangement attached to a patient to the fluid container via the adapter of the present invention. 
     The adapter comprises a body member connected between a spike member and a locking collar. The body member includes a body portion having a generally cylindrical shape and an annular ring formed thereon with a plurality of protrusions which are longitudinally formed along the body member. A pair of leg portions axially extends from the body portion with retention tabs formed at the free end thereof for engaging the body member to the spike member. The adapter further comprises a hollow rolling seal diaphragm positioned within the body member for providing a leak-free seal within the adapter during operation. 
     The spike member is coupled to the body member and includes a spike body which is generally frusto-conical in shape with an opposed pair of slots formed longitudinally along the spike body which are sized and shaped to slidably receive a corresponding protrusion formed along the body portion. An axial spike to penetrate the seal of the fluid container outwardly extends from the spike body and includes a longitudinal slot formed therealong which terminates at an angularly skewed end. Two generally opposed openings are formed through the spike body and are sized and shaped to receive and securely retain a respective leg portion of the body member thereto. As a result, the spike member is slidably coupled with the body member. The spike member also includes a tube adapter at its proximal end which axially extends therefrom and is adapted to attach the adapter of the present invention to the administration tubing set. 
     The locking collar is coupled to the body member and has a hollow cylindrical shape forming a chamber with opposed openings. An annular groove is adjacent one of the openings and is sized and shaped to be engaged by the annular ring formed around the body member such that the locking collar is engaged to the body member but rotates freely thereabout. The locking collar also includes an internal threaded portion disposed within the chamber proximate the other opposed opening for mating engagement with the external threaded portion of the fluid container when the adapter is attached thereto. 
     One unique aspect of the present invention is that it includes a hollow rolling seal diaphragm member disposed at least partially within the body member. The hollow rolling seal diaphragm member defines a diaphragm body having opposed openings and with a rolling seal portion and flange formed proximate one of the openings. More particularly, the rolling seal portion includes an outer portion with an inner portion integrally joined thereto, and substantially coaxially aligned with, the outer portion. Proximate the other opening, the diaphragm body includes an outer stepped portion. Once properly aligned within the body member, the outer stepped portion is sealingly engaged between the body member and the locking collar, while the flange crowns the other opening of the body member. In addition, the inwardly stepped portion of the diaphragm is adapted to abut the shoulder portion of the spike. 
     In operation, the operator of the present invention may easily and securely connect the adapter between the nutrition container and the administration tube set by first threading the threaded portion of the locking collar onto the threaded portion of the cap while the spike is isolated within the locking collar from inadvertent contact which may result in contamination of the spike. It will be appreciated that, although the adapter is secured to the container, the spike does not simultaneously pierce and breach the foil that seals off the orifice of the fluid container. Once the locking collar is properly secured, the administration tubing set is connected to the patient&#39;s tube arrangement while the spike member is maintained in the disengaged position. The operator will then grasp the spike body between the thumb and forefinger and move the spike member axially forward relative to the body member so that the spike extends forward from the locking collar and is driven through the foil of the fluid container, thereby establishing fluid flow. After the foil has been breached and fluid flow established, the operator will then release the spike member which will then be biased back within the locking collar in the disengaged position by the diaphragm. During operation of the adapter, the rolling seal diaphragm maintains a fluid tight seal about the axial spike as the spike is moved longitudinally. 
     Accordingly, the primary object of the present invention is to provide an adapter which is capable of establishing fluid flow communication between a fluid container and an administration tube set while maintaining a fluid-tight seal. 
     A further object of the present invention is to provide a rolling seal diaphragm that maintains a fluid-tight seal around the axial spike during operation of the adapter. 
     Another object of the present invention is to provide a connection device that allows the container to be sealingly connected to the administration tube set without simultaneously piercing the flexible membrane. 
     Another further object of the present invention is to provide a retractable touch free spike. 
     These and other objects of the present invention are realized in the preferred embodiment of the present invention, described by way of example and not by way of limitation, which provides for an adapter having a retractable spike and rolling seal diaphragm for establishing leak-free fluid flow communication between a fluid container and an administration tubing set. 
     Additional objects, advantages and novel features of the invention will be set forth in the description which follows, and will become apparent to those skilled in the art upon examination of the following more detailed description and drawings in which like elements of the invention are similarly numbered throughout. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1, is a cross-sectional view of a preferred embodiment of the adapter connected between a fluid container and an administration tubing set according to the present invention; 
     FIG. 2, is a perspective view of a preferred embodiment of the adapter according to the present invention; 
     FIG. 3 is an exploded perspective view of the preferred embodiment of the adapter according to the present invention; 
     FIG. 4 a  is a side elevational view of the preferred embodiment of the adapter in an unactuated position according to the present invention; 
     FIG. 4 b  is a side elevational view of an alternative embodiment of the adapter in an unactuated position according to the present invention; 
     FIG. 5 is a top plan view of the preferred embodiment of the adapter in an unactuated position according to the present invention; 
     FIG. 6 is a cross-section of the preferred embodiment of the adapter along line A—A of FIG. 4 a  according to the present invention; 
     FIG. 7 is a cross-section of the preferred embodiment of the adapter along line B—B of FIG. 5 according to the present invention; 
     FIG. 8 is a top plan view of the preferred embodiment of the adapter in an actuated position according to the present invention; 
     FIG. 9 is a side elevational view of the preferred embodiment of the adapter in an actuated position according to the present invention; 
     FIG. 10 is a cross-sectional view of the preferred embodiment of the adapter along line C—C of FIG. 8 according to the present invention; 
     FIG. 11 is a cross-sectional view of the preferred embodiment of the adapter along line D—D of FIG. 9 according to the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to the drawings, the preferred embodiment of the adapter for a feeding system of the present invention is illustrated and generally indicated as  10  in FIG.  2 . As illustrated in FIG. 1, adapter  10  operates as a connector between a fluid container  88  and an administration tubing set  90  with the fluid container  88  including a cap  92  that has an orifice  96  and threading  98  disposed about the cap  92 . A foil  100 , or other frangible membrane, seals off the orifice  96  of container  88  from fluid flow. The administration tubing set  90  includes tubing  94  which interconnects a tube arrangement (not shown) which is connected to a patient to the fluid container  88  via the adapter  10  of the present invention. As shown in FIG. 2, the adapter  10  comprises a body member  12  slidably connected to a spike member  14  and rotatably connected to a locking collar  16 . In addition, as seen in FIG. 3, adapter  10  further includes a rolling seal diaphragm  18  disposed within the body member  12 . 
     As best appreciated with reference to the exploded view shown in FIG. 3, the body member  12  comprises a hollow body portion  20  having opposed openings  25 ,  27  which form a channel  31  therebetween with a pair of laterally opposed leg portions  26  which extend axially proximate the opening  27 . As shown, the preferred embodiment has a pair of leg portions  26 . In the alternative, one skilled in the art can best appreciate that any suitable number of leg portions  26  may be utilized without departing from the teachings of the present invention. Each leg portion  26  includes a tab  22  formed at the free end of each leg portion  26 . Preferably, tabs  22  are bifurcated along the free end thereof. 
     The body member  12  further includes an interior annular ridge  23  formed adjacent opening  27  and two pairs of opposed protrusions  28  longitudinally aligned and extending along the body portion  20 . Formed between each pair of protrusions  28  is a beveled portion  30  defining a ledge  32 . Further, body member  12  includes an exterior annular flange  34  formed proximate opening  25 . Alternatively, it should be appreciated that any suitable number of protrusions  28  may be utilized without departing from the teachings of the present invention. 
     As seen in FIGS. 3,  4   a , and  4   b , spike member  14  of adapter  10  comprises a spike body  42  defining two opposed pairs of longitudinal slots  44  which correspond to the two opposed pairs of protrusions  28  formed on body member  12 . Each slot  44  is sized and shaped to slidably receive a corresponding protrusion  28  when the spike member  14  is in the actuated position, as shall be discussed in greater detail below. In addition, spike member  14  further includes two axial openings  43 , as particularly shown in FIG. 3, which are sized and shaped to receive and retain a corresponding tab  22  of each leg portion  26 . Alternatively, one skilled in the art can appreciate that any number of slots  44  and openings  43  may be utilized to interconnect the body member  12  to spike member  14  without departing from the teachings of the present invention. 
     With reference to FIGS. 4 a ,  4   b , and  6 , each pair of slots  44  define a retention section  46  which includes a retention edge  48  formed at a distal or free end of each section  46 . Each section  46  is positioned between a respective corresponding pair of protrusions  28  and is adapted to slide between each pair of protrusions  28  while traveling along the corresponding beveled surface  30  formed on the body member  12 . During the aforementioned sliding action, the section  46  is prevented from separating from body member  12  due to the engagement between retention edge  48  of spike member  14  and the ledge  32  formed on body member  12  as well as the relative action of tab  22  with spike body  42 , as shall be described with greater detail later. 
     As best appreciated in FIG. 7, spike member  14  further includes an axial spike  52  outwardly extending from the spike body  42  defining opposed ends  36 ,  38  which form a channel  40  therebetween. With particular reference to FIG. 3, spike  52  includes a distal longitudinal slot  56  formed along a portion of spike  52  and that terminates at an angularly skewed end  54 . Referring back to FIG. 7, circumferentially disposed about the spike  52  is a shoulder portion  58  which assists in forming a seal between the spike member  14  and diaphragm  18  as will be discussed in greater detail below. Spike body  42  further includes a proximal tube adapter  60  formed opposite spike  52  having an opening  61  aligned with spike  52  proximate end  36  and sized and shaped to be connected to administration tubing set  90 , as illustrated in FIG.  1 . Preferably, spike  52  is disposed entirely within the adapter  10  as illustrated in FIG. 4 a . In an alternative embodiment shown in FIG. 4 b , spike  52  extends beyond the collar  16  when adapter  10  is fully assembled. 
     Referring to FIG. 6, adapter  10  of the present invention also includes locking collar  16  comprising a body portion  62  with opposed openings  65 ,  66  forming a channel  64  therebetween. Channel  64  includes an annular groove  67  formed proximate opening  65  and a threaded portion  68  formed proximate opening  66 . As seen in the preferred embodiment shown in FIG. 4 a , longitudinal grooves  70  are formed along the body portion  62  of the locking collar  16  to enhance the ability of the operator to grasp the locking collar  16 . However, one skilled in the art can best appreciate that a variety of other connective arrangements may be utilized without departing from the teachings of the present invention. 
     As illustrated in FIG. 3, one unique aspect of adapter  10  is that it includes rolling seal diaphragm  18  which forms and maintains a fluid-tight seal during operation of adapter  10 . With reference to FIGS. 3 and 10, diaphragm  18  comprises a body portion  72  which includes a pair of opposed openings  73 ,  75  with a channel  77  formed therebetween. Diaphragm  18  further comprises an annular flange  74  disposed proximate opening  73  and circumferentially disposed about the body portion  72 , while an outer stepped portion  76  is formed proximate opening  75 . The diaphragm  18  also is provided with a rolling seal portion  80  which is attachable to, or integral with, opening  73  and located adjacent flange  74  of body member  72 . In particular, the rolling seal portion  80  includes an outer portion  82  and an inner portion  84  attached to, or integral with the outer portion  82  which is coaxially aligned and disposed within the outer portion  82 . Both the inner portion  84  and outer portion  82  are generally cylindrical in shape. Attached to, or integral with, the inner portion  84  is an inwardly stepped portion  86  which abuts the shoulder portion  58  of the spike  52  and forms a rolling seal between the spike  52  and the inwardly stepped portion  86  of diaphragm  18  as the spike  52  is forced axially forward to the engaged position during operation of adapter  10 . As the spike  52  is urged forward, the inward portion  84  of rolling seal portion  80  rolls along the spike  52  which is sealingly engaged therealong due to the engagement between the shoulder portion  58  of spike  52  and the inwardly stepped portion  86  of diaphragm  18 . In response, the outer portion  82  of rolling seal portion  80  rolls inwardly allowing the inwardly stepped portion  86  to maintain a sealing engagement between moving spike  52  and diaphragm  18 . 
     With particular reference to FIG. 3, adapter  10  is assembled during manufacturing by first inserting diaphragm  18  within body member  12  by inserting diaphragm  18  through opening  25 . Diaphragm  18  is then aligned within channel  31  such that the flange  74  crowns the ridge  23 , while the outer stepped portion  76  abuts the opening  25  of body member  12  so that rolling seal portion  80  extends outwardly from body portion  20 . Next, spike member  14  is connected to body member  12  and aligned such that each corresponding protrusion  28  is slidably received within each corresponding slot  44  of spike body  42 . Spike member  14  is then axially depressed onto body member  12  until tabs  22  are passed through the corresponding openings  43  and retention edge  48  are disposed adjacent the beveled portion  30 . The collar  16  is then engaged about the body member  12  so that annular flange  34  of body member  12  is engagingly received within the annular groove  66  of locking collar  16 . Once assembled, spike member  14  may be biased between two positions: an actuated position, wherein spike member  14  abuts locking collar  16 , as illustrated in FIGS. 10 and 11, and an unactuated position, wherein spike member  14  abuts tabs  22  of the body member  12 , as seen in FIGS. 4 a  and  5 . 
     In operation, the adapter  10  of the present invention is uniquely configured to interconnect the fluid container  88  to the administration tubing set  90 . As seen in FIG. 1, the adapter  10  is connected to the fluid container  88  by screwing the threaded portion  68  of the locking collar  16  onto the threaded portion  98  of the cap  92  while the spike  52  is isolated within the collar  16  to prevent undesirable contact and contamination of the axial spike  52 . The operator then connects tube  94  which has been bonded to tube adapter  60  to the patient&#39;s tube arrangement. When it is desirable to actuate adapter  10  and establish fluid flow, the user will grasp spike member  14  preferably between the user&#39;s thumb and forefinger (not shown) and urge the spike member  14  forwardly as illustrated in FIGS. 8 and 9, through collar  16 . With particular reference to FIGS. 10 and 11, the forward axial motion of spike  52  is restrained at one point by the abutment of retention edge  48  of spike member  14  with collar  16 . As the spike member  14  is actuated by the user, the inward portion  84  of the rolling seal portion  80  rolls along the spike  52  which is sealingly engaged therealong due to the engagement between the shoulder portion  58  of spike  52  and the inwardly stepped portion  86  of diaphragm  18 . In response, outer portion  82  of the rolling seal portion  80  rolls inwardly allowing the inwardly stepped portion  86  to maintain a sealing engagement between spike  52  and diaphragm  18 . Once adapter  10  has been properly actuated, the operator will simply release spike member  14 , as seen in FIGS. 4 a  and  5 . Referring back to FIGS. 10 and 11, due to the inherent spring force of diaphragm  18 , the spike member  14  will be automatically biased back towards the unactuated position with spike  52  isolated within collar  16  as the deformed rolling seal portion  80  unrolls back into its original undeformed orientation. 
     In the preferred embodiment, body member  12 , the spike member  14 , and the locking collar  16  are constructed from a substantially rigid medical-grade material, while diaphragm  18  is constructed from a substantially flexible elastic material. Most preferably, the body member  12 , the spike member  14 , and the locking collar  16  are constructed from a thermoplastic, such as ABS and the like, while diaphragm  18  is constructed from a thermoplastic, thermosetting rubber or other similar elastomeric material. 
     It should be understood from the foregoing that, while particular embodiments of the invention have been illustrated and described, various modifications can be made thereto without departing from the spirit and scope of the present invention. Therefore, it is not intended that the invention is limited by the specification; instead, the scope of the present invention is intended to be limited only by the appended claims.