EP0637227A1 - Recipient de fluide et constituant de raccordement - Google Patents

Recipient de fluide et constituant de raccordement

Info

Publication number
EP0637227A1
EP0637227A1 EP93912282A EP93912282A EP0637227A1 EP 0637227 A1 EP0637227 A1 EP 0637227A1 EP 93912282 A EP93912282 A EP 93912282A EP 93912282 A EP93912282 A EP 93912282A EP 0637227 A1 EP0637227 A1 EP 0637227A1
Authority
EP
European Patent Office
Prior art keywords
tube
seal
proximal
fluid
spike
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP93912282A
Other languages
German (de)
English (en)
Other versions
EP0637227A4 (fr
Inventor
Alan B. Ranford
James G. Schneider
Richard A. Sunderland
Dennis Selwyn Segal
Curtis D. Kinghorn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sherwood Medical Co
Original Assignee
Sherwood Medical Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sherwood Medical Co filed Critical Sherwood Medical Co
Publication of EP0637227A1 publication Critical patent/EP0637227A1/fr
Publication of EP0637227A4 publication Critical patent/EP0637227A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports

Definitions

  • the invention relates to fluid containers and connection components for connecting the fluid containers to a fluid delivery system and more particularly relates to fluid containers and connection components for connecting fluid containers containing enteral feeding fluids to an enteral feeding fluid administration set.
  • Enteral feeding systems typically include a container of enteral feeding fluid, an enteral feeding tube for delivering the enteral feeding fluid to a patient's intestinal system and a connection component system for connecting the enteral feeding tube to the fluid container.
  • the connection component system typically includes an administration set including tubing connecting the fluid container to the enteral feeding tube.
  • the administration set is connected to the fluid container through a connection component and is connected to the enteral feeding tube through a port mounted on the feeding tube.
  • the enteral feeding tube remains in place within the patient for several days at a time while the enteral fluid container and the administration set are changed every 24 hours.
  • a fluid container having a pierceable seal covering the opening.
  • connection component is positioned in proximity of the seal.
  • connection component has a hollow pointed projecting member at one end that is connected to the tubing of an administration set.
  • the hollow pointed projecting member is aligned with and positioned slightly away from the seal.
  • the pointed projection is movable to pierce the seal thereby communicating the fluid in the container through the hollow projecting member to the administration set tubing.
  • the pointed projection is prevented from inadvertently moving to pierce the seal by retaining means.
  • the retaining means may be selectively disengaged thereby allowing the hollow projecting member to move to pierce the seal as described above.
  • the fluid container and the administration set are provided together in a set with the container prefilled with fluid and the connection component connecting the container and the administration set with the hollow projecting member retained in position aligned with and positioned slightly away from the seal.
  • Figure 1 is a perspective view of the prefilled enteral fluid bag and an administration set connected by a connection component.
  • Figure 2 is a cutaway and partial cross-sectional view of one embodiment of the invention.
  • Figure 3 is a plan view of the position housing of the invention of Figure 2.
  • Figure 4 is a side cross-sectional view of the position housing of Figure 3 along the line labeled 4-4 in Figure 3.
  • Figure 5 is an end view of the position housing shown in Figure 3.
  • Figure 6 is a cross-sectional view of the position housing in Figure 3 along the line labeled 6-6 in Figure 4.
  • Figure 7 is a plan view of the locking tube of the invention of Figure 2.
  • Figure 8 is a cross-sectional view of the locking tube of Figure 7 along the line labeled 8-8.
  • Figure 9 is an end view of the locking tube shown in Figure 7.
  • Figure 10 is a cross sectional view of an alternate embodiment of the seal and connection component of Figure 1.
  • Figure 11 is a perspective view of the preferred embodiment of the safety stop of the invention.
  • Figure 12 is a perspective view of an alternate embodiment of the safety stop of the invention.
  • Figure 13 is a cross-sectional view of an alternate embodiment of the seal and connection component of Figure 1.
  • Figure 14 is a cutaway and partial cross-sectional view of the embodiment of Figure 13 with the tang aligned with the longitudinal groove.
  • Figure 15 is a plan view of part of the retaining means of the connection component of Figure 13.
  • Figure 16 is a cross-sectional view of an alternate embodiment of the invention.
  • Figure 17 is a cross-sectional view of an alternate embodiment of the invention.
  • Figure 18 is a partial cutaway and a partial cross- sectional view of an embodiment of the invention.
  • Figure 19 is a partial cutaway and a partial cross- sectional view of the invention of Figure 18 along the line labeled 19-19 in Figure 18.
  • Figure 20 is a perspective view of the invention of Figure 18 with the spike shown in phantom.
  • Figure 21 is a cross-sectional view of the invention of Figure 18 in its collapsed position.
  • Fig. 22 is part sectional and part perspective view of the container showing the connection component fitted onto the container without piercing the seal.
  • Fig. 23 is a part sectional and part perspective view of showing the connection component screwed onto the container with the seal pierced.
  • FIG. 1 shows a system 1 having a fluid container 2 connected to an administration set 4 through a connection component 6.
  • the fluid container 2 and the administration set 4 are provided together in a set with the container 2 prefilled with fluid.
  • connection component 6 connecting the container 2 and the administration set 4 does not allow the fluid in the container 2 to enter the tubing of the administration set 4 until the system 1 is to be used with a patient.
  • connection component 6 is preconnected to both the container 2 and the administration set 4 and sealed so that the fluid pathway from the fluid container 2 through the connection component 6 to the administration set 4 may not be contaminated by contact with the clinician.
  • fluid container 2 is prefilled with fluid in the preferred embodiment, it is also within the scope of the invention to provide the fluid container 2 without fluid and have the fluid placed in the container 2 at a later time.
  • like elements are referred to by like reference numbers. Small variations in the shape of like elements, such as will be readily apparent to and clearly understood by those skilled in the art, may be found from one embodiment to the next. However, the description of an element and its function are equally applicable whenever the like element is described or referred to throughout this description.
  • Figures 2 through 10 show the preferred embodiment of the invention.
  • a hollow seal mount 8 is preferably integrally formed with and extends away from container 2 ending in a seal 10.
  • Seal mount 8 is preferably molded as part of the container 2. Alternately, seal mount 8 may be a separate piece attached to container 2 by any means as will be well understood to those skilled in the art. In either case, seal mount 8 is roughly cylindrical with a central bore 12 and is made of a semi-rigid thermoplastic material such as polyethylene or a laminated material with oxygen and moisture barrier properties. A flat disc shaped seal 10 is placed across the distal end of seal mount 8. Throughout this description, proximal refers generally to a direction toward container 2 while distal refers generally to a direction away from container 2. Seal 10 is made of a material that is frangible for a purpose that will be described hereafter.
  • seal 10 is preferably a laminate of plastic and foil as is well understood by those skilled in the art. Seal 10 is sealed to seal mount 8 by means such as heat sealing or other similar means. Fluid present within container 2 is also present in the interior of seal mount 8 in bore 12 proximal to and in contact with seal 10.
  • Connection component 6 includes a positioning housing 14 that surrounds and is attached to seal mount 8. Positioning housing 14 extends distally beyond seal mount 8. Positioning housing 14 is preferably cylindrical and has a cylindrical bore 16 that extends through positioning housing.14 aligned with the central axis of seal mount 8. Cylindrical bore 16 ends at its proximal end in bore 17 that has a somewhat smaller diameter that bore 16 for a purpose to be described hereafter.
  • Figures 2 through 6 show views of positioning housing 14. As can be seen, an annular flange 18 extends away from positioning housing 14 at approximately a right angle near the proximal end of positioning housing 14. A flat bottomed annular locking groove 20 extends into and around positioning housing 14 distal and adjacent to flange 18.
  • a pair of diametrically opposed planar flats 22, 24 extend into positioning housing 14 on opposite sides of positioning housing 14 near the distal end of positioning housing 14.
  • the proximal end of flats 22, 24 forms a right angle.
  • a generally annular flange 28 extends away from positioning housing 14 at approximately a right angle near the distal end of positioning housing 14.
  • Flange 28 is chamfered on its distal side.
  • Flange 28 has a pair of flats 23, 25 located adjacent and parallel to and a small distance away from flats 22, 24.
  • the proximal surface of flange 28 contacts both flats 22, 24 and the outer surface 34 of positioning housing 14 at a right angle thereby forming a lip of approximately equal height around outer surface 34 and flats 22, 24.
  • Connection component 6 also includes a spike mount 36. As shown in Figures 7 through 9, a flange 38 is located near the distal end of spike mount 36.
  • Spike mount 36 includes a cylindrical locking tube 40 having central bore 42 that extends proximally away from and at a right angle to flange 38.
  • the proximal end of locking tube 40 has a pair of opposed inwardly directed tangs 44. Tangs 44 preferably extend inwardly from locking tube 40. Tangs 44 each have a width B (Fig. 9) less than the width A of flats 22, 24.
  • Tangs 44 also each have a contact surface 46.
  • the distance between contact surfaces 46 across bore 42 is equal to or somewhat less than the distance C (Fig. 6) between flats 22, 24 across bore 16.
  • a hollow cylindrical projecting member 48 extends through flange 38 at a right angle to flange 38 within and concentric with locking tube 40. Projecting member 48 has an outer diameter somewhat less than the diameter of bore 12. Projecting member 48 ends at one end in a sharp, pointed spike 50. Projecting member 48 opposite spike 50 extends beyond flange 38 and ends in a connection mount 49.
  • Connection mount 49 is connected to the administration set 4.
  • the connection of connection mount 49 to administration set 4 creates a fluid pathway from administration set 4 through hollow projecting member 48.
  • the method of connecting administration set 4 to connection mount 49 may be of any number of methods well understood in the art including but not limited to solvent bonding, adhesive bonding or a mechanical locking system.
  • Spike mount 36 and positioning housing 14 are preferably manufactured of a rigid thermoplastic material such as polycarbonate, PVC or ABS.
  • a semi-rigid strain relief 52 surrounds the connection between the administration set 4 and connection mount 49 to prevent strain caused by movement of the administration set 4 relative to connection component 6 from kinking or breaking the administration set 4 where it is connected to connection mount 49.
  • connection component 6 the longitudinal axis of locking tube 40 is aligned with the longitudinal axis of positioning housing 14 so that tangs 44 are aligned with flats 23, 25 on flange 28.
  • Locking tube 40 is moved proximally so that the contact surfaces 46 of tangs 44 move first over the chamfered distal side of flange 28 and then over flats 23, 25 finally coming into contact with flats 22, 24. Because contact surfaces 46 of tangs 44 move over flats 23, 25 instead of over any other portion of the outer edge of flange 28, strain ' on tangs 44 resulting from being distended while moving over flange 28 is minimized.
  • Locking tube 40 is prevented from proximal movement by contact between tangs 44 and the walls of positioning housing 14 that are formed at right angles to flats 22, 24 as described above. Locking tube 40 is prevented from distal movement by contact between tangs 44 and the proximal side of flange 28 at flats 23, 25.
  • spike 50 With tangs 44 seated on flats 22, 24, spike 50 is positioned adjacent to but not in contact with seal 10. In this position, the system 1 may be stored or transported ready for use but without fear that spike 50 may inadvertently move into contact with and rupture seal 10 or that spike mount 36 will separate from positioning housing 14.
  • locking tube 40 When it is desired to use the system 1, locking tube 40 is rotated about its longitudinal axis thereby moving tangs 44 across the edge 32 of flats 22, 24 and onto the outer surface 34 of positioning housing 14. This allows locking tube 40 to be moved proximally toward flange 18. Contact between tangs 44 and flange 28 prevents locking tube 40 from moving distally. The consequence of locking tube 40 moving distally is that locking tube 40 separates from positioning housing 14.
  • Locking tube 40 is moved proximally until tangs 44 enter groove 20. At this time, contact between tangs 44 and flange 18 prevents further proximal movement of locking tube 40. Contact between tangs 44 and the wall formed at the distal edge of inward surface 26 and positioning housing 14 prevents distal movement of locking tube 40. Consequently, iocking tube 40 is "locked” into position with spike 50 projecting through seal 10 and projecting member 48 in an interference fit with bore 17 so that leakage of fluid past seal 10 is prevented. In this position, fluid within container 2 passes through projecting member 48 to administration set 4.
  • Figure 10 shows an alternate embodiment of the invention.
  • seal mount 8 is attached to and extends from container 2.
  • Seal 10 is preferably integrally mounted to the distal end of seal mount 8.
  • Seal mount 8 also has a bore 12 extending through seal mount 8 and in contact with seal 10. In this way fluid within container 2 is in contact with seal 10 through bore 12.
  • Connection component 6 includes a positioning housing 56 that surrounds seal mount 8 and extends distally beyond seal mount 8.
  • Positioning housing 56 is preferably rigid, cylindrical, hollow and ends at its distal end in a bore 58 that is tapered, narrowing in a proximal direction.
  • a cavity 60 is formed within positioning housing 56 between bore 58 and seal 10.
  • Cavity 60 generally has an inner diameter somewhat larger than the diameter of bore 58 except for a portion distal to seal 10 where cavity.60 narrows to a bore 61 having a diameter slightly smaller than the projecting member 48.
  • a hollow projecting member 48 extends through bore 58, ending at its proximal end in a spike 50.
  • Spike 50 is contained within cavity 60 and is concentrically aligned with seal 10.
  • a tapered flange 62 extends away from projecting member 48 a short distance distal to spike 50. Once assembled into positioning housing 56, flange 62 prevents spike 50 from moving distally out of cavity 60.
  • a second tapered flange 64 extends around projecting member 48 distal to the first flange 62. Flanges 62 and 64 have diameters slightly larger than the diameter of bore 58.
  • connection mount 49 is connected to the administration set 4.
  • the connection of connection mount 49 to administration set 4 creates a fluid pathway from administration set 4 through hollow projecting member 48.
  • a strain relief 52 surrounds the connection of connection mount
  • Projecting member 48 may move along its longitudinal axis through bore 58 constrained in its proximal movement by contact between flange 64 and the distal edge of bore 58 and constrained in its distal movement by contact between flange
  • a stop flange 66 extends away from projecting member 48 at a right angle near the distal end of projecting member 48.
  • Flange 66 has an outer diameter sufficiently large to prevent further proximal movement when flange 66 contacts the distal face of positioning housing 56.
  • a safety stop 68 is placed between the distal edge of bore 58 and flange 66.
  • safety stop 68 is partially cylindrical and surrounds a significant portion of projecting member 48.
  • safety stop 68 is cylindrical and entirely surrounds a portion of projecting member 48.
  • safety stop 68 contains a frangible portion 70 that allows safety stop 68 to be removed from around projecting member 48.
  • a tab In either embodiment, a tab
  • Safety stop 68 and tab 72 extends away from safety stop 68 to enable it to be grasped between the thumb and forefinger.
  • Safety stop 68 and tab 72 are preferably integrally made of a rigid material such as plastic so that with safety stop 68 in position between the distal edge of bore 58 and flange 66, projecting member 48 is prevented from moving proximally toward the positioning housing 56.
  • safety stop 68 when in place, encircles only a portion of projecting member 48. Grasping and pulling tab 72 removes safety stop 68 from around projecting member 48.
  • safety stop 68 entirely surrounds projecting member 48.
  • safety stop 68 includes a frangible portion 70 that breaks the continuous safety stop 68 at frangible portion 70. With safety stop 68 in place in continuous circumference around projecting member 48, grasping and twisting tab 72 causes frangible portion 70 to break. Then, safety stop 68 may be removed from around projecting member 48 by pulling on tab 72.
  • positioning housing 56 is placed around seal mount 8 and connected to container 2.
  • the administration set 4 is attached to connection mount 49 within a strain relief 52 so that a fluid pathway is formed through the spike 50, projecting member 48 and administration set 4 within strain relief 52 thereby connecting the spike 50 with the administration set 4.
  • the container 2 is preferably prefilled with enteral fluid.
  • the safety stop 68 is applied around projecting member 48 between flanges 62 and 66. Spike 50 is inserted within cavity 60 aligned with seal 10. Safety stop 68 is then in position between the distal face of positioning housing 56 and flange 66 so that projecting member 48 is securely positioned against movement through bore 58.
  • the spike 50 is aligned with but is spaced a small distance away from seal 10.
  • Safety stop 68 prevents proximal movement of projecting member 48 thereby preventing the spike 50 from moving proximally into contact with, and thereby rupturing, seal 10.
  • seal mount 8 is preferably integrally formed with and extends away from container 2 ending in a seal 10. In this way fluid within container 2 is in contact with seal 10. Seal mount 8 includes a bore 12 as described above.
  • Connection component 6 includes a positioning housing 74 that surrounds seal mount 8 and extends distally beyond seal mount 8.
  • Positioning housing 74 is preferably cylindrical, hollow and has a central bore 76.
  • At least one locking.channel 78 ( Figure 15) is located on the outer surface 80 of positioning housing 74 at the distal end of positioning housing 74. Locking channel 78 extends into positioning housing 74 a small distance. If two tangs 44 are used, as will be described hereafter, an additional locking channel 78 may be positioned on the outer surface 80 of positioning housing 74 opposite the first locking channel 78.
  • Each locking channel 78 consists of two transverse grooves 82 and 90 connected by a longitudinal groove 88.
  • the transverse grooves 82 and 90 may contain narrow portions 84 and 92, respectively, for a purpose to be described hereafter.
  • Connecting component 6 includes a locking tube assembly
  • Locking tube assembly 96 has a flange 98 located at its distal end.
  • a projecting member 48 extends through flange 98.
  • Projecting member 48 is hollow and has an outer diameter smaller than the diameter of flange 98.
  • Projecting member 48 ends at its proximal end in a spike 50.
  • Spike 50 is contained within bore 76 and is concentrically aligned with seal 10.
  • the distal end of projecting member 48 is in fluid communication with administration set 4.
  • a strain relief 52 surrounds the connection between projecting member 48 and administration set 4.
  • Locking tube assembly 96 includes a cylindrical locking tube 100 that surrounds and is concentric with projecting member 48.
  • the proximal end of locking tube 100 has at least one inwardly directed tang 44 having a height about equal to the depth of locking channel 78.
  • an additional inwardly directed tang 44 is placed on locking tube 100 opposite the first tang 44.
  • Locking tube 100 is placed around positioning housing 74 so that tang 44 is positioned within locking channel 78. Locking tube 100 has a length so that when tang 44 is in transverse groove 90, spike 50 is aligned with but spaced away a small distance from seal 10.
  • transverse groove 90 contains a narrow portion 92.
  • tang 44 When tang 44 is moved into the most transverse end 94 of transverse groove 90, tang 44 must be moved through the narrow passage created by narrow portion 92. Once tang 44 has moved past narrow portion 92, tang 44 is "locked” in position between narrow portion 92 and the most transverse end 94 of transverse groove 90. In this position, shown in Figure 13, contact between the proximal edge of transverse groove 90 and tang 44 prevents locking tube 100, and consequently projecting member 48, from proximal movement.
  • Tang 44 may be moved past narrow portion 92 into alignment with longitudinal groove 88 by rotating the locking tube 100 relative to the positioning housing 74.
  • locking tube assembly 96 and consequently projecting member 48 may be moved proximally. This brings the spike 50 into contact with seal 10. Further proximal movement of projecting member 48 forces the spike 50 through seal 10 so that a fluid pathway is provided from container 2 through projecting member 48 and strain relief 52 into the administration set 4.
  • tang 44 may be rotated into locking groove 82.
  • locking groove 82 contains a narrow portion 84.
  • tang 44 When tang 44 is moved into the most transverse end 86 of locking groove 82, tang 44 must be moved through the narrow passage created by narrow portion 84.
  • FIG 16 shows an embodiment of the system 1 shown in Figure 1.
  • a seal mount 8 protrudes away from container 2.
  • Seal mount 8 is preferably molded as part of the container 2.
  • seal mount 8 may be a separate piece attached to container 2 by any means as will be well understood to those skilled in the art. In either case, seal mount 8 is roughly cylindrical and made of a semi-rigid thermoplastic material such as polyethylene.
  • Seal mount 8 has an inner bore 12 extending proximally from the distal end of seal mount 8.
  • An annular flange 102 is located along seal mount 8 and extends away from and entirely encircles seal mount 8.
  • Flange 102 is preferably tapered so that the proximal side of flange 102 has a larger outer diameter than the distal side of flange 102.
  • the proximal side of flange 102 forms a lip 104.
  • Seal mount 8 ends at its distal end in a flat disc shaped seal 10 as described above. Seal 10 extends across the distal end of bore 12. As above, fluid present within container 2 is also present in the interior of seal mount 8 and bore 12 and is in contact with seal 10.
  • Connection component 6 includes a cylindrical outer housing 106 having a proximal end 108 and a distal end 110.
  • Outer housing 106 has a longitudinal axis aligned with the longitudinal axis of seal mount 8 and is positioned around seal mount 8.
  • the proximal end 108 of outer housing 106 includes an inwardly directed ring 112 that contacts the outer surface of seal mount 8 when outer housing 106 surrounds seal mount 8.
  • Ring 112 is preferably tapered so that the distal side of ring 112 has a greater diameter than the proximal side of ring 112.
  • the distal side of ring 112 forms a lip 114.
  • an additional lip 116 extends inwardly from outer housing 106 a distance distal to ring 112. The distance from lip 114 to lip 116 is equal to or slightly less than the distance rom the proximal side of ring 112 to the connection of container 2 to seal mount 8.
  • a safety stop 68 surrounds seal mount 8 between the body of container 2 and proximal end 108 of outer housing 106.
  • safety stop 68 surrounds seal mount 8 for more than half the circumference of seal mount 8.
  • safety stop 68 may entirely surround seal mount 8 and include a frangible portion 70 as described above.
  • a tab 72 extends away from safety stop 68 and both are preferably integrally made of a rigid material such as plastic.
  • Safety stop 68 is placed between the proximal side of ring 112 and the connection of container 2 to seal mount 8.
  • Safety stop 68 prevents the outer housing 106 from moving in a proximal direction toward the body of container 2. Grasping and pulling tab 72 removes safety stop 68 from around seal mount 8.
  • Connection component 6, in this embodiment, includes a hollow projecting member 48 extending from the distal end 110 of connection component 6.
  • Projecting member 48 has an outer diameter somewhat smaller than the diameter of bore 12.
  • the proximal end of projecting member 48 terminates in a spike 50.
  • Spike 50 has a sharp pointed proximal end.
  • the administration set 4 is connected to connection component 6 at the distal end 20 of connection component 6.
  • a strain relief 52 surrounds the connection between the administration set 4 and connection component 6 and extends distally along the administration set 4 to prevent strain from movement of the administration set 4 from kinking the administration set 4 or from damaging the connection between the administration set 4 and connection component 6.
  • the connection of connection component 6 to administration set 4 creates a fluid pathway from administration set 4 inside strain relief 52 to the hollow projecting member 48.
  • the method of connecting administration set 4 to connection component 6 may be of any number of methods well understood in the art including but not limited to solvent bonding, adhesive bonding or a mephanical locking system.
  • a sealing member 118 extends around projecting member 48 from the distal end 110 of connection component 6. Sealing member 118 surrounds and is concentric with projecting member 48. With the safety stop 68 in place, the proximal end of sealing member 118 contacts the distal end of seal mount 8 so that contact between the proximal end of sealing member 118 and the distal end of seal mount 8 creates a sliding seal. In this way, any fluid within container 2 that passes by the central opening of spike 50 and escapes into the area around spike 50 is retained within sealing member 118.
  • safety stop 68 is placed around seal mount 8. The longitudinal axis of connection component 6 is aligned with the longitudinal axis of seal mount 8.
  • Outer housing 106 is moved proximally until the proximal side of ring 112 contacts the distal side of flange 102. Continued proximal movement of connection component 6 moves ring 112 over flange 102. The tapered shape of ring 112 and flange 102 facilitates this relative movement. Contact between safety stop 68 and the proximal end of outer housing 106 limits proximal movement of outer housing 106 relative to seal mount 8.
  • the container 2 is preferably prefilled with enteral fluid.
  • spike 50 is aligned with but is spaced a small distance away from seal 10.
  • Safety stop 68 prevents proximal movement of connection component 6 thereby preventing the spike 50 from moving proximally into contact with, and thereby rupturing, seal 10.
  • safety stop 68 is removed, as described above, by grasping and pulling tab 72.
  • Safety stop 68 is then removed from around seal mount 8. With safety stop 68 removed, connection component 6 is moved proximally toward container 2 thereby bringing the spike 50 into contact with seal 10. Further proximal movement of connection component 6 forces the spike 50 through seal 10 so that a fluid pathway is provided from container 2 through projecting member 48 and administration mount 52 into the administration set 4.
  • connection component 6 When connection component 6 has been moved proximally so that spike 50 has ruptured seal 10 and a fluid pathway is provided from container 2 through projecting member 48 into the administration set 4, contact between lip 116 and lip 104 holds connection component 6 in place relative to seal mount 8 and prevents the fluid pathway from being broken. The seal created by sealing member 118 engaging the distal end of seal mount 8 prevents fluid from container 2 from leaking out of connection component 6.
  • Figure 17 is the embodiment shown in Figure 16 described above without sealing member 118 and with the inclusion of an "0"-ring 120 or other sealing method including but not limited to a lip seal system as is well understood in the art.
  • "0"-ring 120, or the other sealing system used, entirely encircles the distal end of seal mount 8. Except as stated, this embodiment operates as described above in connection with the embodiment shown in Figure 16.
  • an "0"-ring 120 or other sealing system is placed entirely around seal mount 8 proximal to the distal end of seal mount 8.
  • "0"-ring 120 forms a seal between the seal mount 8 and outer housing 106 so that any fluid from container 2 that may have found its way into the space within outer housing 106 will not escape outer housing 106.
  • FIG. 18 through 21 An alternate embodiment of the invention is shown in Figures 18 through 21.
  • the container 2 is connected an administration set 4 through a connection component 6 including a first grip tube 122.
  • First grip tube 122 is preferably cylindrical with an outer surface 124 having a high degree of friction that allows the outer surface 124 to be easily gripped. Examples of treatments to the outer surface 124 include knurled, grooved, burnished, molded with small protrusions or other means such as will be clear to those skilled in the art.
  • Container 2 preferably includes a seal mount 8 that ends in a seal 10 such as is described above.
  • Seal mount 8 preferably includes a flexible annular ledge 152 extending around the periphery of seal 10.
  • First grip tube 122 preferably fits around and encases seal mount 8 and seal 10.
  • First grip tube 122 is attached to container 2 by any suitable means including but not limited to solvent bonding, adhesive bonding or a mechanical locking system.
  • Connecting component 6 also includes a second grip tube 126.
  • Second grip tube 126 is also preferably cylindrical with an outer surface 128 having a high degree of friction that allows the outer surface 128 to be easily gripped as described above in connection with first grip tube 122.
  • a conical spike 130 extends away from second grip tube 126 along the longitudinal axis of second grip tube 126.
  • Spike 130 has a hollow connecting tube 132 extending away from the point 134 of spike 130.
  • Spike 130 has an inlet opening 136 at the proximal end of spike 130 near the connecting point of connecting tube 132 and spike 130.
  • Administration set 4 is attached to the distal end of connecting tube 132 by any number of methods well understood in the art including but not limited to solvent bonding, adhesive bonding or a mechanical locking system. Inlet opening 136, connecting tube 132 and administration set 4 form a fluid path.
  • a pair of opposed locking tabs 138 extend away from the outer surface 124 of first grip tube 122 at approximately a right angle.
  • Each locking tab 138 has a fin 140 and a lip 142 extending along the distal edge of fin 140.
  • a pair of opposed locking tabs 144 extend away from the outer surface 128 of second grip tube 126 at approximately a right angle.
  • Each locking tab 144 has a fin 146 and a lip 148 extending along the proximal edge of fin 146.
  • Fins 140 and 146 preferably extend away from outer surfaces 124 and 128, respectively, at approximately a right angle. Further, fins 140 and 146 may be generally planar or they may be formed in rubber sheet geometry in helical form.
  • Lips .142 and 148 correspond in shape so that they will mate with each other to form a "lock" as will be described hereafter.
  • a semi-rigid skirt 150 connects the distal edge of first grip tube 122 with the proximal edge of second grip tube 126.
  • Skirt 150 is preferably made of a relatively thin, for example .010 to .015", polyolefin material such as polyethylene or polypropylene. Skirt 150 may be attached to first and second grip tubes 122 and 126 by any means as will be clear to those skilled in the art. Skirt 150 has sufficient length and rigidity so that in its unstressed position, the proximal end 134 of spike 130 is positioned adjacent to but not in contact with seal 10.
  • first and second grip tubes 122 and 126, and locking tabs 138 and 144 are preferably made of a polyolefin material such as polyethylene or polypropylene having a sufficient thickness to be rigid.
  • first grip tube 122 and second grip tube 126 are simultaneously grasped and rotated in opposite directions. This causes skirt 150 to twist in a helical fashion (Fig. 20) drawing second grip tube 126 nearer to first grip tube 122.
  • Locking tabs 144 move along a helical path 154 (Fig. 20) .
  • the proximal end of spike 130 moves into contact with and ruptures seal 10 (Fig. 21) . Fluid present within container 2 flows through inlet opening 136, connecting tube 132 and administration set 4 to the patient.
  • first and second grip tubes 122 and 126 continue to be rotated in opposite directions, locking tabs 144 are moved toward a corresponding locking tab 138 until lips 148 ride up over lips 142 and mate to "lock” and thereby prevent second grip tube 126 from rotating in a direction toward first grip tube 122. This prevents second grip tube 126 from moving distally away from first grip tube 122, thereby moving spike 130 out of contact with seal 10 and the fluid within container 2.
  • spike 130 preferably abuts annular ledge 152 extending around the periphery of seal 10. This abutting relation forms a seal between spike 130 and ledge 152 so that fluid present within container 2 will not flow past spike 130 into the area between first and second grip tubes 122 and 126 that is encased by skirt 150.
  • spike 130 may not placed be in sealing contact with ledge 152.
  • the combination of spike 130 and ledge 152 forms a silt trap that allows silt collected on or near seal 10 to be washed away from inlet opening 136 by fluid within container 2 leaking past ledge 152 between ledge 152 and spike 130 and carrying the silt. In this way, as spike 130 pierces seal 10, silt is washed away from seal 10 with the leaked fluid.
  • FIGs 22 and 23 An alternate embodiment of the invention is shown in Figures 22 and 23. Referring to Figure 22 a container 2 filled with enteral feeding fluid has a foil seal 10.
  • the neck 156 is threaded and receives a connection component 6 in the shape of a cap 158 provided with a hollow projecting member 48 having a spike 50 with a sharp pointed end and a fluid receiving opening 160 facing away from the center.
  • the cap 158 has an airvent 162 with a one way valve 164.
  • An annular ring 166 is screwed onto the neck 156 of the container 2 and occupies a first position 168 in which it is held by means of adhesive. In this position the projecting member 48 cannot pierce the foil seal 10.
  • the tubular projecting member 48 is connected to an administration set 4 through an strain relief 52 shown in part in. Figures 22 and 23.
  • the airvent 162 is provided with a removable cap 170.
  • the adhesive seal of the ring 166 can be broken by a twisting force and the ring 166 screwed down the neck 156 of the container 2 to a second position 172 shown in Figure 23.
  • the cap 158 can then be screwed further down the neck 156 of the container to break the seal 10 and permit fluid to enter the hollow projecting member 48 and the administration set 4.
  • the stop means comprises an annular ring 166 movable along the threaded portion from a first position 168 to a second position 172, the first position 168 being such that the cap 158 abuts the ring 166 and the projecting member 48 cannot pierce the seal 10, and the second position 172 being such that the cap 158 can be screwed further onto the container 2 whereby the projecting member 48 pierces the seal 10.
  • the ring 166 may be held in the first position 168 by an adhesive seal which can be broken by a twisting force exerted on the ring 166.
  • the stop means may comprise a removable safety stop 68 which can be peeled off the threaded portion of the container 2.
  • the container 2 and administration set 4 are provided in a sterile package. In use the operator screws the cap 158 onto the container 2 without running the risk of contaminating the connection component 6.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention se rapporte à un système d'amenée de fluide entérique (1) possédant un récipient de fluide (2) à obturateur perçable (10) recouvrant une ouverture du récipient (2). Un constituant de raccordement (6) relie un ensemble d'administration (4) au récipient (2) de fluide. Le constituant de raccordement (6) comporte un tube creux (48, 132) qui est relié à l'ensemble d'administration (4) à une extrémité, et possède une pointe (50, 130) à l'autre extrémité. Pendant le stockage et le transport, la pointe (50, 130) est alignée avec l'obturateur (10) et postionnée légèrement à l'oppose de celui-ci. Lors du fonctionnement, la pointe (50, 130) peut se déplacer de manière linéaire pour percer l'obturateur (10), faisant ainsi passer le fluide se trouvant dans le récipient (2) par le tube (48, 132) jusqu'à l'ensemble d'administration du fluide (4). On empêche la pointe (50, 130) de se déplacer accidentellement pour qu'elle ne perce l'obturateur (10), au moyen d'éléments de retenue. Les éléments de retenue peuvent être libérés sélectivement, permettant ainsi à la pointe (50, 130) de se déplacer pour percer l'obturateur (10). Dans le mode préféré de réalisation de l'invention, le récipient de fluide (2) et l'ensemble d'administration de fluide (4) sont regroupés en un ensemble, le récipient (2) étant prérempli de fluide, ainsi que le constituant de raccordement (6) reliant le récipient (2) et l'ensemble d'administration du fluide (4) à la pointe (50, 130) maintenue en position alignée avec l'obturateur (10) et placée légèrement à l'opposé de celui-ci.
EP93912282A 1992-04-22 1993-04-22 Recipient de fluide et constituant de raccordement. Withdrawn EP0637227A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9208713 1992-04-22
GB929208713A GB9208713D0 (en) 1992-04-22 1992-04-22 Fluid container and connection component
PCT/US1993/003598 WO1993020772A1 (fr) 1992-04-22 1993-04-22 Recipient de fluide et constituant de raccordement

Publications (2)

Publication Number Publication Date
EP0637227A1 true EP0637227A1 (fr) 1995-02-08
EP0637227A4 EP0637227A4 (fr) 1995-04-19

Family

ID=10714387

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93912282A Withdrawn EP0637227A4 (fr) 1992-04-22 1993-04-22 Recipient de fluide et constituant de raccordement.

Country Status (4)

Country Link
EP (1) EP0637227A4 (fr)
AU (1) AU4288993A (fr)
GB (1) GB9208713D0 (fr)
WO (1) WO1993020772A1 (fr)

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CN102389371A (zh) * 2005-05-27 2012-03-28 巴克斯特国际有限公司 接入端口

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US5839715A (en) * 1995-05-16 1998-11-24 Alaris Medical Systems, Inc. Medical adapter having needleless valve and sharpened cannula
US5762646A (en) * 1996-09-30 1998-06-09 Duxbury Scientific, Inc. Blood collection system and coupling
DE19927356C2 (de) 1999-06-16 2001-09-27 Fresenius Ag Verlängerbare Konnektoranordnung mit einem Anschlußsystem und einem Portsystem zur Verbindung eines Schlauches und eines medizinischen Behälters
FR2801797B1 (fr) * 1999-12-02 2002-11-08 Cair L G L Connecteur male non luer destine a equiper un premier dispositif medical en vue de son raccordement avec le connecteur femelle non luer correspondant d'un second dispositif medical
US7544191B2 (en) * 2002-10-22 2009-06-09 Baxter International Inc. Formed, filled, sealed solution container, port and method for establishing flow between the container and an administration set
US8100879B2 (en) * 2002-11-18 2012-01-24 Nestec S.A. Connector device for enteral administration set
US20090204080A1 (en) * 2008-02-12 2009-08-13 Baxter International Inc. Two-way valve connector
FR2939864B1 (fr) * 2008-12-12 2010-12-03 Cie Mediterraneenne Des Cafes Connecteur, systeme et procede de raccordement de deux organes hydrauliques.
US8628509B2 (en) 2009-05-11 2014-01-14 Abbott Laboratories Enteral connectors and systems
DE102013205813A1 (de) 2013-04-02 2014-10-02 Parker Hannifin Manufacturing Germany GmbH & Co. KG Fluidventil- und -verbindungsvorrichtung

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WO1983002395A1 (fr) * 1982-01-11 1983-07-21 Baxter Travenol Lab Systeme de serrage pour dialyse peritoneale ambulatoire continue
EP0256640A2 (fr) * 1986-06-20 1988-02-24 Bieffe Medital S.A. Dispositif de connexion pour dialyse péritonéale
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EP0497229A1 (fr) * 1991-01-30 1992-08-05 Vincent L. Vaillancourt Raccordement pour système de tubes fermés

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US3986508A (en) * 1973-08-22 1976-10-19 Abcor, Inc. Sterilizable, medical connector for blood processing
WO1983002395A1 (fr) * 1982-01-11 1983-07-21 Baxter Travenol Lab Systeme de serrage pour dialyse peritoneale ambulatoire continue
EP0256640A2 (fr) * 1986-06-20 1988-02-24 Bieffe Medital S.A. Dispositif de connexion pour dialyse péritonéale
AT386523B (de) * 1987-04-22 1988-09-12 Machat Wolfgang Dr Kupplung fuer peritonealdialysegeraete
US4895570A (en) * 1987-06-05 1990-01-23 Abbott Laboratories Locking port shroud for peritoneal dialysis tubing connector
EP0497229A1 (fr) * 1991-01-30 1992-08-05 Vincent L. Vaillancourt Raccordement pour système de tubes fermés

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Publication number Priority date Publication date Assignee Title
CN102389371A (zh) * 2005-05-27 2012-03-28 巴克斯特国际有限公司 接入端口
CN102389371B (zh) * 2005-05-27 2014-06-18 巴克斯特国际有限公司 接入端口

Also Published As

Publication number Publication date
WO1993020772A1 (fr) 1993-10-28
AU4288993A (en) 1993-11-18
EP0637227A4 (fr) 1995-04-19
GB9208713D0 (en) 1992-06-10

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