US20020143300A1 - Fluid delivery system and an aseptic connector for use therewith - Google Patents
Fluid delivery system and an aseptic connector for use therewith Download PDFInfo
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- US20020143300A1 US20020143300A1 US10/158,977 US15897702A US2002143300A1 US 20020143300 A1 US20020143300 A1 US 20020143300A1 US 15897702 A US15897702 A US 15897702A US 2002143300 A1 US2002143300 A1 US 2002143300A1
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- Prior art keywords
- delivery system
- fluid delivery
- connector
- fluid
- wall
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Classifications
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- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1033—Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
-
- 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
- A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S604/00—Surgery
- Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
Definitions
- the present invention relates to an aseptic connector or coupler and to a fluid delivery system using such an aseptic connector, and, more particularly, to an aseptic connector and fluid delivery system for use in medical procedures in which a fluid is delivered at a relatively high pressure.
- Aseptic connectors are commonly used in the medical arts, but most aseptic connectors are limited to use at relatively low pressures. In some medical procedures, however, it is desirable to deliver a liquid under relatively high pressures. In radiological procedures such as computer tomography (CT), for example, a liquid contrast medium is injected into a patient at pressures of approximately 300 psi. Although, there are connectors currently used at high pressures in the medical arts, such “high-pressure” connectors generally rely upon a friction fit to create a high-pressure seal and are not aseptic.
- CT computer tomography
- the present invention provides generally an aseptic connector comprising a first member and a second member.
- the first member preferably includes a resilient septum
- the second member preferably includes a penetrating member.
- the septum is formed from an elastomeric material such as a silicone elastomer.
- the penetrating member preferably includes an extending penetrating element to penetrate the resilient septum.
- the aseptic connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
- the seal formed between the penetrating member and the inner wall of the first member or the inner wall of the second member is suitable for use at relatively high pressures.
- the seal is preferably suitable for use (that is, will maintain a seal and not leak) at pressures of at least 100 psi. More preferably, the seal is suitable for use at pressures of at least 150 psi. Most preferably, the seal is suitable for use at pressures of at least 300 psi.
- the resilient sealing element preferably comprises an annular, elastomeric member that is axially compressed when the first member and the second member are brought together.
- the axial compression of the annular, elastomeric member causes a radial expansion which exerts radial pressure upon the penetrating member and the inner wall of the first member or the inner wall of the second member to form the seal between the penetrating member and the inner wall of the first member or the inner wall of the second member.
- the resilient septum preferably has at least one generally circular enclosed end, which is attached to the annular, elastomeric member.
- the generally circular enclosed end is preferably fabricated from an elastomer such as a silicone elastomer that is preferably suitable for repeated penetration by the penetrating element.
- the circular enclosed end of the septum and the annular, elastomeric member are formed integrally from such a material.
- the annular, elastomeric member is preferably seated in a generally cylindrical seating chamber formed in the first member. This seating chamber preferably has an inner wall having a diameter slightly greater than an outside diameter of the annular, elastomeric member.
- the annular, elastomeric member preferably has an inner diameter slightly greater than the outer diameter of the penetrating element. Upon axial compression of the annular, elastomeric member, a seal is formed between the penetrating element and the inner wall of the seating chamber.
- the annular, elastomeric member is extended in length to have a generally cylindrical shape.
- the penetrating member preferably includes an abutment shoulder that axially compresses the annular, elastomeric member when the first member and the second member are brought together.
- This abutment shoulder is preferably a radially outward extending shoulder on the penetrating member.
- the first member of the aseptic connector preferably further includes a first threaded section and the second member of the aseptic connector preferably includes a second threaded section.
- the first threaded section and the second threaded section are adapted to cooperate to securely and releasably connect the first member to the second member.
- the first threaded connection and the second threaded connection also assist in enabling the user to axially compress the annular, elastomeric member as the first member and the second member are brought into releasable connection.
- the present invention also provides a fluid delivery system comprising at least a first aseptic connector as described above.
- the fluid delivery system further comprises a pump system in fluid connection with one of the first member and the second member of the aseptic connector. The other of the first member and the second member is in fluid connection with the patient.
- the fluid delivery system preferably further comprises a dual check valve.
- the other of the first member and the second member is connected to a first outlet of the dual check valve.
- the pump system is connected to a second outlet of the dual check valve, and a source of the fluid is connected to the inlet of the dual check valve.
- the fluid delivery system preferably further comprises a check valve in fluid connection between the patient and the other of the first member and the second member.
- the fluid delivery system preferably further comprises a second aseptic connector in which one of a first member of the second aseptic connector and a second member of the second aseptic is connected to the inlet of the dual check valve.
- the other of the first member of the second aseptic connector and the second member of the second aseptic connector is connected to the source of the fluid.
- the second aseptic connector is designed as described above.
- the aseptic coupler or connector of the present invention is suitable for use at relatively high pressures while being relatively simple in design and operation.
- the aseptic connector of the present invention is also inexpensive to fabricate, making it (or one of its first and second members) suitable for disposal after only a single use, if desired.
- the unique design of the aseptic connector of the present invention also makes it suitable for repeated use at relatively high pressures.
- the aseptic connector of the present invention maintains a leak proof seal at high pressures after many such uses.
- FIG. 1 is a cross-sectional view of one embodiment of a female member of an aseptic connector of the present invention.
- FIG. 2 is a cross-sectional view of one embodiment of a male member of an aseptic connector of the present invention.
- FIGS. 3A through 3D illustrated the cooperation of the female member of FIG. 1 and the male member of FIG. 2 to form a releasable aseptic connection.
- FIG. 4 is a cross-sectional view of another embodiment of an aseptic connector in which the male and female members are in a disconnected state.
- FIG. 5 is a cross-sectional view of the embodiment of the aseptic connector of FIG. 4 in which the male and female members are in a connected state.
- FIGS. 6A and 6B illustrate an embodiment of a fluid delivery system incorporating the aseptic connector of FIGS. 1 through 3D.
- a first or female member 10 preferably comprises a generally cylindrical base member 15 having a passage 20 therethrough.
- Passage 20 is preferably in fluid connection with a seating area or chamber 25 formed within base member 15 .
- Seating chamber 25 preferably comprises a generally cylindrical passage having a diameter larger than the diameter of passage 20 .
- Seating chamber 25 is adapted to seat a flexible or resilient septum 50 therein.
- Septum 50 preferably comprises a generally cylindrical side portion 55 and a generally circular end portion 60 .
- Generally cylindrical side portion 55 and generally circular end portion 60 are preferably formed integrally from an elastomeric material, such as a silicone elastomer.
- the outer diameter of side portion 55 is preferably slightly less than the diameter of seating chamber 25 .
- Base member 15 preferably further includes a retention member 70 to retain septum 50 within seating chamber 25 .
- retention member 70 extends radially inward (with respect to axis A) around the perimeter of seating chamber 25 .
- Base member 15 also preferably includes a mechanism, such as threaded portion 75 , on an outside wall thereof to form a releasable connection with a second member 100 .
- Base member 15 preferably also comprises an extending member 80 in fluid connection with passage 20 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.
- Base member 15 is preferably fabricated from a relatively rigid polymeric material.
- the connector of the present invention also comprises second or male member 100 .
- Second member 100 comprises a penetrating member 110 .
- Penetrating member 110 comprises a generally cylindrical penetrating element 115 extending from a first end thereof.
- a passage 120 is formed through penetrating element 115 and the remainder of penetrating member 110 .
- the second end of penetrating member 110 preferably forms an extending member 122 in fluid connection with passage 120 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.
- Second member 100 also preferably includes a swivel member 125 rotatably connected to penetrating member 110 .
- swivel member 125 comprises a passage 130 through which penetrating member 110 passes.
- penetrating member 110 is rotatably connected to swivel member 125 through the cooperation of an annular depression 135 formed in penetrating member 110 and a radially inward extending flange 140 on swivel member 125 .
- Swivel member 125 preferably further includes a threaded portion 145 on an interior surface thereof to cooperate with threaded portion 75 of first member 10 .
- penetrating member 110 and swivel member 125 are fabricated from a relatively rigid polymeric material.
- FIGS. 3A through 3D The cooperation of first element 10 and second element 100 to form an aseptic connection is illustrated in FIGS. 3A through 3D.
- First member 10 and second member 100 are first drawn axially together as illustrated in FIG. 3A.
- penetrating element 115 pierces flexible septum 50 (see FIG. 3B)
- swivel member 125 is rotated relative to base member 15 to engage threaded portions 145 and 75 .
- threaded portions 145 and 75 are tightened, bringing first member 10 and second member 100 in closer contact, an abutment shoulder 150 of penetrating member 110 exerts axial force upon septum 50 .
- septum 50 which preferably has an inner diameter slightly greater than the outer diameter of penetrating element 115 ) is thereby compressed and exerts force generally symmetrically around penetrating element 115 and against the inner wall of seating chamber 25 to create a tight and substantially leak proof seal therebetween.
- the substantial axial and radial forces upon septum 50 (and the resultant seal) enable use of the aseptic connector at relatively high pressures.
- passage 20 and passage 120 are in fluid connection to allow flow of a fluid through the aseptic connector.
- penetrating element 115 is preferably sized such that it does not directly contact any portion of first member 10 other than septum 50 . As penetrating element 115 has been exposed to the exterior environment, contact of penetrating element 115 only with septum 50 assists in preventing cross contamination between first member 10 and second member 100 . Penetrating element 115 must also be of sufficient length to extend beyond septum 50 to ensure unobstructed flow through passage 120 .
- threaded portions 75 and 145 of first member and second member cooperate to retain first member and second member together, and to thereby maintain the tight and substantially leak proof seal of the aseptic connector.
- the cooperation of threaded portions 75 and 145 also acts to maintain the interior of the aseptic connector in an aseptic condition, until disengagement as illustrated in FIG. 3D.
- septum 50 substantially prevents leakage of fluid from first member 10 .
- FIGS. 4 and 5 illustrate another embodiment of an aseptic connector 150 of the present invention.
- Aseptic connector 150 comprises a first or female member 155 and a second or male member 175 .
- First member 155 is preferably generally cylindrical in shape and comprises a septum 160 enclosing one end thereof.
- First member 155 also preferably comprises an extending member 162 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.
- Extending member 162 has a passage 164 formed therein, which is in fluid connection with an interior 166 of first member 155 .
- First member 155 also preferably comprises threading 170 on an exterior wall thereof.
- Second member 175 comprises a penetrating member 180 .
- Penetrating member 180 comprises a generally cylindrical penetrating element 182 extending from a first end thereof.
- a passage 184 is formed through penetrating element 182 and the remainder of penetrating member 180 .
- the second end of penetrating member 180 preferably forms an extending member 186 in fluid connection with passage 184 to which a conduit or connector (not shown), such as flexible tubing or a luer connection, can be attached.
- Second member 180 also preferably includes a swivel member 190 rotatably connected to penetrating member 180 as described above.
- Swivel member 190 preferably includes threading 192 on an interior surface thereof to cooperate with threading 170 on first member 155 .
- Second member 175 also preferably includes opposing wing elements 194 extending radially outward therefrom to facilitate rotation of second member 175 relative to first member 155 to form a threaded connection of first member 155 and second member 175 .
- first member 155 and second member 175 are first drawn axially together.
- swivel member 190 is rotated relative to first member 155 to engage threaded portions 170 and 192 .
- threaded portions 170 and 192 are tightened, bringing first member 150 and second member 175 into closer contact, a forward surface 172 of first member 155 contacts an annular, elastomeric member 196 seated in a generally cylindrical interior chamber 198 of second member 175 .
- Annular, elastomeric member 196 is thereby compressed generally symmetrically around penetrating member 180 and against the inner wall of swivel member 190 to create a tight and substantially leak proof seal between penetrating member 180 and the interior wall of swivel member 190 .
- the substantial axial and radial forces upon annular, elastomeric member 196 (and the resultant seal) enable use of aseptic connector 150 at relatively high pressures.
- FIG. 6A illustrates an embodiment of a fluid (for example, contrast media) delivery system 200 incorporating an aseptic connector as described in FIGS. 1 through 3B.
- aseptic connector 150 of FIGS. 4 and 5 is equally suitable for use in fluid delivery system 200 .
- Other fluid delivery systems in which the aseptic connector of the present invention can be used are discussed U.S. Pat. No. 5,569,181, the disclosure of which is incorporated herein by reference.
- Delivery system 200 preferably includes a disposable patient interface 300 in releasable fluid connection with an outlet 360 of a pumping system, such as a manual or injector-powered syringe 350 .
- a pumping system such as a manual or injector-powered syringe 350 .
- a powered injector and syringe suitable for use in the present invention is described in U.S. Pat. No. 5,383,585, the disclosure of which is incorporated herein by reference.
- Other pumping systems such as rotary pumps and gear pumps, are also suitable for use in the present invention.
- disposable patient interface 300 preferably comprises an IV catheter 310 .
- IV catheter 310 is preferably in fluid connection with a check valve 320 or other suitable means to ensure unidirectional flow of the medium into the patient.
- Check valve 320 is in fluid connection with flexible tubing 330 .
- Flexible tubing is preferably in fluid connection with extending member 122 of male member 100 of the aseptic connector.
- Female member 10 of the aseptic connector is preferably in fluid connection with powered syringe 350 .
- female member 10 is in fluid connection with a first outlet 410 of dual check valve 400 via extending member 80 of female member 10 .
- a second outlet 420 of dual check valve 400 is preferably in releasable fluid connection with syringe 350 via, for example, a luer connection.
- Inlet 430 of dual check valve 400 is preferably in fluid connection with female member 10 ′ of a second aseptic connector of the present invention via extending member 80 ′ thereof.
- Female member 10 ′ is preferably in releasable fluid connection with a disposable source of contrast medium 500 .
- a male member 100 ′ is preferably in fluid connection with a contrast container 505 .
- male member 100 ′ is in fluid connection with the first end of a length of conduit 510 via extending member 122 ′.
- the second end of conduit 510 is in fluid connection with a spike 520 designed to penetrate a septum (not shown) of container 505 , as known in the art.
- plunger 355 of syringe 350 is first drawn rearward (toward powered injector 360 ).
- the negative pressure created within syringe 355 causes a valve of inlet 430 of dual check valve 400 to open and contrast medium to flow into syringe 350 from contrast container 505 via second outlet 420 .
- the negative pressure within syringe 350 causes a valve of second outlet 410 to remain closed.
- plunger 355 is advanced forwardly (away from powered injector 360 ) to create a positive pressure within syringe 350 and thereby inject contrast medium into the patient.
- the positive pressure within syringe 350 causes the valve of inlet 430 of dual check valve 400 to close and the valve of second outlet 410 to open, thereby allowing the contrast medium to be injected into the patient via disposable patient interface 300 .
- the releasable nature of the aseptic connector of the present invention allows male member 100 to be disconnected from female member 10 so that disposable patient interface 300 may be discarded, preferably after each injection procedure.
- the disposable nature of patient interface 300 assists in preventing cross contamination between patients.
- male member 100 ′ is disconnectable from female member 10 ′.
- Fluid source 500 including contrast container 505 , conduit 510 and male member 100 ′, can thus be discarded when contrast container 505 is emptied.
- Dual check valve 400 can be reused with a new contrast container 505 and a new male member 100 ′ if so desired.
- Syringe 350 can be released from dual check valve 400 so that syringe 350 , dual check valve 400 and female members 10 and 10 ′ attached thereto can be discarded periodically.
- syringe 350 , dual check valve 400 and female members 10 and 10 ′ can be discarded daily or after a certain number of injection procedures, such as, for example, 6-8 procedures, have been completed during the day.
- septums 50 and 50 ′ are preferably cleaned using an aseptic technique between procedures by, for example, wiping septums 50 and 50 ′ with alcohol to reduce the likelihood of contamination.
- conduit 510 can be connected directly to inlet 430 of dual check valve 400 without an intermediate releasable aseptic connection.
- container 505 , conduit 510 , dual check valve 400 , and female member 10 are preferably discarded periodically as a unit.
- those components may be discarded daily or upon emptying of container 500 .
- septum 50 is preferably cleaned using an aseptic technique between injection procedures.
Abstract
A fluid delivery system includes a valve device, a pump system operable to pressurize a fluid and a patient interface. The valve device includes a sealing element and defines at least a first outlet and a second outlet. The first outlet includes a first member of a connector. The pump system is operably associated with the second outlet of the valve device. The patient interface includes a second member of the connector and a tube in fluid connection with the second member. The second member of the connector is adapted to be removably connected to the first member of the connector. The first member preferably includes a resilient septum, and the second member preferably includes a penetrating member. The connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
Description
- This application is a continuation of application Ser. No. 09/507,274, filed on Feb. 18, 2000, which is a continuation of application Ser. No. 09/015,175, filed on Jan. 29, 1998, now U.S. Pat. No. 6,096,011, the contents of which are hereby incorporated by reference.
- The present invention relates to an aseptic connector or coupler and to a fluid delivery system using such an aseptic connector, and, more particularly, to an aseptic connector and fluid delivery system for use in medical procedures in which a fluid is delivered at a relatively high pressure.
- Aseptic connectors are commonly used in the medical arts, but most aseptic connectors are limited to use at relatively low pressures. In some medical procedures, however, it is desirable to deliver a liquid under relatively high pressures. In radiological procedures such as computer tomography (CT), for example, a liquid contrast medium is injected into a patient at pressures of approximately 300 psi. Although, there are connectors currently used at high pressures in the medical arts, such “high-pressure” connectors generally rely upon a friction fit to create a high-pressure seal and are not aseptic.
- As a result, it is very desirable to develop aseptic connectors and delivery systems incorporating such aseptic connectors that are suitable for use at relatively high pressures.
- The present invention provides generally an aseptic connector comprising a first member and a second member. The first member preferably includes a resilient septum, and the second member preferably includes a penetrating member. Preferably, the septum is formed from an elastomeric material such as a silicone elastomer. The penetrating member preferably includes an extending penetrating element to penetrate the resilient septum. The aseptic connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
- The seal formed between the penetrating member and the inner wall of the first member or the inner wall of the second member is suitable for use at relatively high pressures. In that regard, the seal is preferably suitable for use (that is, will maintain a seal and not leak) at pressures of at least 100 psi. More preferably, the seal is suitable for use at pressures of at least 150 psi. Most preferably, the seal is suitable for use at pressures of at least 300 psi.
- The resilient sealing element preferably comprises an annular, elastomeric member that is axially compressed when the first member and the second member are brought together. The axial compression of the annular, elastomeric member causes a radial expansion which exerts radial pressure upon the penetrating member and the inner wall of the first member or the inner wall of the second member to form the seal between the penetrating member and the inner wall of the first member or the inner wall of the second member.
- In one embodiment, the resilient septum preferably has at least one generally circular enclosed end, which is attached to the annular, elastomeric member. The generally circular enclosed end is preferably fabricated from an elastomer such as a silicone elastomer that is preferably suitable for repeated penetration by the penetrating element. Preferably, the circular enclosed end of the septum and the annular, elastomeric member are formed integrally from such a material. The annular, elastomeric member is preferably seated in a generally cylindrical seating chamber formed in the first member. This seating chamber preferably has an inner wall having a diameter slightly greater than an outside diameter of the annular, elastomeric member. The annular, elastomeric member preferably has an inner diameter slightly greater than the outer diameter of the penetrating element. Upon axial compression of the annular, elastomeric member, a seal is formed between the penetrating element and the inner wall of the seating chamber. Preferably, the annular, elastomeric member is extended in length to have a generally cylindrical shape.
- In the embodiment of the previous paragraph, the penetrating member preferably includes an abutment shoulder that axially compresses the annular, elastomeric member when the first member and the second member are brought together. This abutment shoulder is preferably a radially outward extending shoulder on the penetrating member.
- The first member of the aseptic connector preferably further includes a first threaded section and the second member of the aseptic connector preferably includes a second threaded section. The first threaded section and the second threaded section are adapted to cooperate to securely and releasably connect the first member to the second member. The first threaded connection and the second threaded connection also assist in enabling the user to axially compress the annular, elastomeric member as the first member and the second member are brought into releasable connection.
- The present invention also provides a fluid delivery system comprising at least a first aseptic connector as described above. The fluid delivery system further comprises a pump system in fluid connection with one of the first member and the second member of the aseptic connector. The other of the first member and the second member is in fluid connection with the patient.
- The fluid delivery system preferably further comprises a dual check valve. The other of the first member and the second member is connected to a first outlet of the dual check valve. The pump system is connected to a second outlet of the dual check valve, and a source of the fluid is connected to the inlet of the dual check valve. The fluid delivery system preferably further comprises a check valve in fluid connection between the patient and the other of the first member and the second member.
- The fluid delivery system preferably further comprises a second aseptic connector in which one of a first member of the second aseptic connector and a second member of the second aseptic is connected to the inlet of the dual check valve. The other of the first member of the second aseptic connector and the second member of the second aseptic connector is connected to the source of the fluid. Preferably, the second aseptic connector is designed as described above.
- The aseptic coupler or connector of the present invention is suitable for use at relatively high pressures while being relatively simple in design and operation. The aseptic connector of the present invention is also inexpensive to fabricate, making it (or one of its first and second members) suitable for disposal after only a single use, if desired. However, the unique design of the aseptic connector of the present invention also makes it suitable for repeated use at relatively high pressures. The aseptic connector of the present invention maintains a leak proof seal at high pressures after many such uses.
- FIG. 1 is a cross-sectional view of one embodiment of a female member of an aseptic connector of the present invention.
- FIG. 2 is a cross-sectional view of one embodiment of a male member of an aseptic connector of the present invention.
- FIGS. 3A through 3D illustrated the cooperation of the female member of FIG. 1 and the male member of FIG. 2 to form a releasable aseptic connection.
- FIG. 4 is a cross-sectional view of another embodiment of an aseptic connector in which the male and female members are in a disconnected state.
- FIG. 5 is a cross-sectional view of the embodiment of the aseptic connector of FIG. 4 in which the male and female members are in a connected state.
- FIGS. 6A and 6B illustrate an embodiment of a fluid delivery system incorporating the aseptic connector of FIGS. 1 through 3D.
- As illustrated in FIG. 1, a first or
female member 10 preferably comprises a generallycylindrical base member 15 having apassage 20 therethrough.Passage 20 is preferably in fluid connection with a seating area orchamber 25 formed withinbase member 15.Seating chamber 25 preferably comprises a generally cylindrical passage having a diameter larger than the diameter ofpassage 20.Seating chamber 25 is adapted to seat a flexible orresilient septum 50 therein.Septum 50 preferably comprises a generallycylindrical side portion 55 and a generallycircular end portion 60. Generallycylindrical side portion 55 and generallycircular end portion 60 are preferably formed integrally from an elastomeric material, such as a silicone elastomer. The outer diameter ofside portion 55 is preferably slightly less than the diameter ofseating chamber 25.Base member 15 preferably further includes aretention member 70 to retainseptum 50 withinseating chamber 25. In the embodiment of FIG. 1,retention member 70 extends radially inward (with respect to axis A) around the perimeter ofseating chamber 25. -
Base member 15 also preferably includes a mechanism, such as threadedportion 75, on an outside wall thereof to form a releasable connection with asecond member 100.Base member 15 preferably also comprises an extendingmember 80 in fluid connection withpassage 20 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.Base member 15 is preferably fabricated from a relatively rigid polymeric material. - As illustrated in FIG. 2, the connector of the present invention also comprises second or
male member 100.Second member 100 comprises a penetratingmember 110. Penetratingmember 110 comprises a generally cylindrical penetratingelement 115 extending from a first end thereof. Apassage 120 is formed through penetratingelement 115 and the remainder of penetratingmember 110. The second end of penetratingmember 110 preferably forms an extendingmember 122 in fluid connection withpassage 120 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached. -
Second member 100 also preferably includes aswivel member 125 rotatably connected to penetratingmember 110. In the embodiment of FIG. 2,swivel member 125 comprises apassage 130 through which penetratingmember 110 passes. In the embodiment of FIG. 2, penetratingmember 110 is rotatably connected to swivelmember 125 through the cooperation of anannular depression 135 formed in penetratingmember 110 and a radially inward extendingflange 140 onswivel member 125.Swivel member 125 preferably further includes a threadedportion 145 on an interior surface thereof to cooperate with threadedportion 75 offirst member 10. Preferably, penetratingmember 110 andswivel member 125 are fabricated from a relatively rigid polymeric material. - The cooperation of
first element 10 andsecond element 100 to form an aseptic connection is illustrated in FIGS. 3A through 3D.First member 10 andsecond member 100 are first drawn axially together as illustrated in FIG. 3A. As penetratingelement 115 pierces flexible septum 50 (see FIG. 3B),swivel member 125 is rotated relative tobase member 15 to engage threadedportions portions first member 10 andsecond member 100 in closer contact, anabutment shoulder 150 of penetratingmember 110 exerts axial force uponseptum 50. Generallycylindrical side portion 55 of septum 50 (which preferably has an inner diameter slightly greater than the outer diameter of penetrating element 115) is thereby compressed and exerts force generally symmetrically around penetratingelement 115 and against the inner wall of seatingchamber 25 to create a tight and substantially leak proof seal therebetween. The substantial axial and radial forces upon septum 50 (and the resultant seal) enable use of the aseptic connector at relatively high pressures. - Upon connection of
first member 10 andsecond member 100,passage 20 andpassage 120 are in fluid connection to allow flow of a fluid through the aseptic connector. As best illustrated in FIG. 3C, penetratingelement 115 is preferably sized such that it does not directly contact any portion offirst member 10 other thanseptum 50. As penetratingelement 115 has been exposed to the exterior environment, contact of penetratingelement 115 only withseptum 50 assists in preventing cross contamination betweenfirst member 10 andsecond member 100.Penetrating element 115 must also be of sufficient length to extend beyondseptum 50 to ensure unobstructed flow throughpassage 120. - As set forth above, threaded
portions portions septum 50 substantially prevents leakage of fluid fromfirst member 10. - FIGS. 4 and 5 illustrate another embodiment of an
aseptic connector 150 of the present invention.Aseptic connector 150 comprises a first orfemale member 155 and a second ormale member 175.First member 155 is preferably generally cylindrical in shape and comprises aseptum 160 enclosing one end thereof.First member 155 also preferably comprises an extendingmember 162 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached. Extendingmember 162 has apassage 164 formed therein, which is in fluid connection with an interior 166 offirst member 155.First member 155 also preferably comprises threading 170 on an exterior wall thereof. -
Second member 175 comprises a penetratingmember 180. Penetratingmember 180 comprises a generally cylindrical penetratingelement 182 extending from a first end thereof. Apassage 184 is formed through penetratingelement 182 and the remainder of penetratingmember 180. The second end of penetratingmember 180 preferably forms an extendingmember 186 in fluid connection withpassage 184 to which a conduit or connector (not shown), such as flexible tubing or a luer connection, can be attached. -
Second member 180 also preferably includes aswivel member 190 rotatably connected to penetratingmember 180 as described above.Swivel member 190 preferably includes threading 192 on an interior surface thereof to cooperate with threading 170 onfirst member 155.Second member 175 also preferably includes opposingwing elements 194 extending radially outward therefrom to facilitate rotation ofsecond member 175 relative tofirst member 155 to form a threaded connection offirst member 155 andsecond member 175. - The cooperation of
first member 155 andsecond member 175 to form an aseptic connection is illustrated in FIGS. 4 and 5. As discussed above in connection withfirst member 10 andsecond member 100,first member 155 andsecond member 175 are first drawn axially together. As penetratingelement 182 piercesflexible septum 160,swivel member 190 is rotated relative tofirst member 155 to engage threadedportions portions first member 150 andsecond member 175 into closer contact, aforward surface 172 offirst member 155 contacts an annular,elastomeric member 196 seated in a generally cylindricalinterior chamber 198 ofsecond member 175. Annular,elastomeric member 196 is thereby compressed generally symmetrically around penetratingmember 180 and against the inner wall ofswivel member 190 to create a tight and substantially leak proof seal between penetratingmember 180 and the interior wall ofswivel member 190. As discussed above, the substantial axial and radial forces upon annular, elastomeric member 196 (and the resultant seal) enable use ofaseptic connector 150 at relatively high pressures. - FIG. 6A illustrates an embodiment of a fluid (for example, contrast media)
delivery system 200 incorporating an aseptic connector as described in FIGS. 1 through 3B. As recognized by one skilled in the art,aseptic connector 150 of FIGS. 4 and 5 is equally suitable for use influid delivery system 200. Other fluid delivery systems in which the aseptic connector of the present invention can be used are discussed U.S. Pat. No. 5,569,181, the disclosure of which is incorporated herein by reference. -
Delivery system 200 preferably includes a disposablepatient interface 300 in releasable fluid connection with anoutlet 360 of a pumping system, such as a manual or injector-poweredsyringe 350. An example of a powered injector and syringe suitable for use in the present invention is described in U.S. Pat. No. 5,383,585, the disclosure of which is incorporated herein by reference. Other pumping systems, such as rotary pumps and gear pumps, are also suitable for use in the present invention. - In the embodiment of FIG. 6A, disposable
patient interface 300 preferably comprises anIV catheter 310.IV catheter 310 is preferably in fluid connection with acheck valve 320 or other suitable means to ensure unidirectional flow of the medium into the patient.Check valve 320 is in fluid connection withflexible tubing 330. Flexible tubing is preferably in fluid connection with extendingmember 122 ofmale member 100 of the aseptic connector. -
Female member 10 of the aseptic connector is preferably in fluid connection withpowered syringe 350. In the embodiment of FIG. 6A,female member 10 is in fluid connection with afirst outlet 410 ofdual check valve 400 via extendingmember 80 offemale member 10. Asecond outlet 420 ofdual check valve 400 is preferably in releasable fluid connection withsyringe 350 via, for example, a luer connection.Inlet 430 ofdual check valve 400 is preferably in fluid connection withfemale member 10′ of a second aseptic connector of the present invention via extendingmember 80′ thereof. -
Female member 10′ is preferably in releasable fluid connection with a disposable source ofcontrast medium 500. In that regard, amale member 100′ is preferably in fluid connection with acontrast container 505. In the embodiment of FIGS. 6A and 6B,male member 100′ is in fluid connection with the first end of a length ofconduit 510 via extendingmember 122′. The second end ofconduit 510 is in fluid connection with aspike 520 designed to penetrate a septum (not shown) ofcontainer 505, as known in the art. - During an injection procedure,
plunger 355 ofsyringe 350 is first drawn rearward (toward powered injector 360). The negative pressure created withinsyringe 355 causes a valve ofinlet 430 ofdual check valve 400 to open and contrast medium to flow intosyringe 350 fromcontrast container 505 viasecond outlet 420. Concurrently, the negative pressure withinsyringe 350 causes a valve ofsecond outlet 410 to remain closed. - After a desired amount of contrast medium is drawn into
syringe 350,plunger 355 is advanced forwardly (away from powered injector 360) to create a positive pressure withinsyringe 350 and thereby inject contrast medium into the patient. The positive pressure withinsyringe 350 causes the valve ofinlet 430 ofdual check valve 400 to close and the valve ofsecond outlet 410 to open, thereby allowing the contrast medium to be injected into the patient via disposablepatient interface 300. - As best illustrated in FIG. 6A, the releasable nature of the aseptic connector of the present invention allows
male member 100 to be disconnected fromfemale member 10 so that disposablepatient interface 300 may be discarded, preferably after each injection procedure. The disposable nature ofpatient interface 300 assists in preventing cross contamination between patients. - Likewise,
male member 100′ is disconnectable fromfemale member 10′.Fluid source 500, includingcontrast container 505,conduit 510 andmale member 100′, can thus be discarded whencontrast container 505 is emptied.Dual check valve 400 can be reused with anew contrast container 505 and a newmale member 100′ if so desired. -
Syringe 350 can be released fromdual check valve 400 so thatsyringe 350,dual check valve 400 andfemale members syringe 350,dual check valve 400 andfemale members dual check valve 400 andfemale members septums septums - As also clear to one skilled in the art, configurations other than set forth in FIGS. 6A and 6B are possible. For example,
conduit 510 can be connected directly toinlet 430 ofdual check valve 400 without an intermediate releasable aseptic connection. In that embodiment,container 505,conduit 510,dual check valve 400, andfemale member 10 are preferably discarded periodically as a unit. For example, those components may be discarded daily or upon emptying ofcontainer 500. Once again,septum 50 is preferably cleaned using an aseptic technique between injection procedures. - Although the present invention has been described in detail in connection with the above examples, it is to be understood that such detail is solely for that purpose and that variations can be made by those skilled in the art without departing from the spirit of the invention. The scope of the invention is indicated by the following claims rather than by the foregoing description. All changes to the present invention that fall within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims (20)
1. A fluid delivery system comprising:
a valve device comprising a sealing element and defining at least a first outlet and a second outlet, the first outlet comprising a first member of a connector;
at least one pump system operably associated with the second outlet of the valve device, the at least one pump system operable to pressurize a fluid; and
a patient interface comprising a second member of the connector and a tubing in fluid connection with the second member, the second member of the connector adapted to be removably connected to the first member of the connector.
2. The fluid delivery system of claim 1 wherein the patient interface further comprises a unidirectional flow device in fluid connection with the tubing between the second member and the patient.
3. The fluid delivery system of claim 2 wherein the unidirectional flow device comprises a check valve.
4. The fluid delivery system of claim 1 wherein the valve device is a dual check valve.
5. The fluid delivery system of claim 1 wherein the valve device further defines a first inlet.
6. The fluid delivery system of claim 5 , further comprising a source of fluid in fluid connection with the first inlet of the valve device.
7. The fluid delivery system of claim 6 wherein the source of fluid comprises a fluid container and a conduit in fluid connection with the fluid container.
8. The fluid delivery system of claim 7 wherein the source of fluid is adapted to be removably connected to the first inlet.
9. The fluid delivery system of claim 8 wherein the first inlet comprises a first member of a second connector and the conduit comprises a second member of the second connector, the first member and the second member of the second connector adapted to be removably connected to one another to removably connect the source of fluid to the valve device.
10. The fluid delivery system of claim 9 wherein the first member of the second connector comprises a resilient septum and the second member of the second connector comprises a penetrating member adapted to penetrate the resilient septum.
11. The fluid delivery system of claim 10 wherein the second connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
12. The fluid delivery system of claim 11 wherein the resilient sealing element comprises an elastomeric member that is compressed when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
13. The fluid delivery system of claim 1 wherein the first member of the connector comprises a resilient septum and the second member of the connector comprises a penetrating member adapted to penetrate the resilient septum.
14. The fluid delivery system of claim 13 wherein the connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
15. The fluid delivery system of claim 14 wherein the resilient sealing element comprises an elastomeric member that is compressed when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.
16. The fluid delivery system of claim 1 wherein the first member of the connector comprises a first threaded section and the second member of the connector comprises a second threaded section, the first threaded section and the second threaded section being adapted to cooperate to releasably connect the first member to the second member.
17. The fluid delivery system of claim 1 wherein the at least one pump system comprises a first member of a luer connection and the second outlet of the valve device comprises a second member of the luer connection, the first and second members of the luer connection being adapted to cooperate to removably connect the at least one pump system to the valve device.
18. The fluid delivery system of claim 1 wherein the at least one pump system comprises a syringe.
19. The fluid delivery system of claim 1 wherein the patient interface is discarded after an injection procedure for a patient is completed to prevent cross-contamination between patients.
20. The fluid delivery system of claim 1 wherein one or both of the at least one pump system and the valve device can be reused for a number of injection procedures.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/158,977 US20020143300A1 (en) | 1998-01-29 | 2002-05-30 | Fluid delivery system and an aseptic connector for use therewith |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US09/015,175 US6096011A (en) | 1998-01-29 | 1998-01-29 | Aseptic connector and fluid delivery system using such an aseptic connector |
US09/507,274 US6440107B1 (en) | 1998-01-29 | 2000-02-18 | Fluid delivery system and an aseptic connector for use therewith |
US10/158,977 US20020143300A1 (en) | 1998-01-29 | 2002-05-30 | Fluid delivery system and an aseptic connector for use therewith |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US09/507,274 Continuation US6440107B1 (en) | 1998-01-29 | 2000-02-18 | Fluid delivery system and an aseptic connector for use therewith |
Publications (1)
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US20020143300A1 true US20020143300A1 (en) | 2002-10-03 |
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US09/015,175 Expired - Lifetime US6096011A (en) | 1998-01-29 | 1998-01-29 | Aseptic connector and fluid delivery system using such an aseptic connector |
US09/507,274 Expired - Lifetime US6440107B1 (en) | 1998-01-29 | 2000-02-18 | Fluid delivery system and an aseptic connector for use therewith |
US10/158,977 Abandoned US20020143300A1 (en) | 1998-01-29 | 2002-05-30 | Fluid delivery system and an aseptic connector for use therewith |
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Application Number | Title | Priority Date | Filing Date |
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US09/015,175 Expired - Lifetime US6096011A (en) | 1998-01-29 | 1998-01-29 | Aseptic connector and fluid delivery system using such an aseptic connector |
US09/507,274 Expired - Lifetime US6440107B1 (en) | 1998-01-29 | 2000-02-18 | Fluid delivery system and an aseptic connector for use therewith |
Country Status (5)
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US (3) | US6096011A (en) |
EP (1) | EP1051218B1 (en) |
JP (1) | JP2002501793A (en) |
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Also Published As
Publication number | Publication date |
---|---|
DE69902576T2 (en) | 2003-07-03 |
EP1051218A1 (en) | 2000-11-15 |
JP2002501793A (en) | 2002-01-22 |
DE69902576D1 (en) | 2002-09-26 |
US6440107B1 (en) | 2002-08-27 |
EP1051218B1 (en) | 2002-08-21 |
WO1999038562A1 (en) | 1999-08-05 |
US6096011A (en) | 2000-08-01 |
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Owner name: MEDRAD, INC., PENNSYLVANIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TROMBLEY, FREDERICK W. III;POMAYBO, AMY;HIRSCHMAN, ALAN D.;AND OTHERS;REEL/FRAME:012897/0091 Effective date: 19980514 |
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