US20020143300A1 - Fluid delivery system and an aseptic connector for use therewith - Google Patents

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

CROSS-REFERENCE TO RELATED APPLICATIONS
• 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.[0001]
BACKGROUND OF THE INVENTION
• 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.[0002]
• 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.[0003]
• 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.[0004]
SUMMARY OF THE INVENTION
• 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.[0005]
• 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.[0006]
• 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.[0007]
• 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.[0008]
• 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.[0009]
• 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.[0010]
• 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.[0011]
• 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.[0012]
• 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.[0013]
• 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.[0014]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross-sectional view of one embodiment of a female member of an aseptic connector of the present invention.[0015]
• FIG. 2 is a cross-sectional view of one embodiment of a male member of an aseptic connector of the present invention.[0016]
• 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.[0017]
• 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.[0018]
• 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.[0019]
• FIGS. 6A and 6B illustrate an embodiment of a fluid delivery system incorporating the aseptic connector of FIGS. 1 through 3D.[0020]
DETAILED DESCRIPTION OF THE INVENTION
• As illustrated in FIG. 1, a first or[0021]female member10 preferably comprises a generallycylindrical base member15 having apassage20 therethrough.Passage20 is preferably in fluid connection with a seating area orchamber25 formed withinbase member15.Seating chamber25 preferably comprises a generally cylindrical passage having a diameter larger than the diameter ofpassage20.Seating chamber25 is adapted to seat a flexible orresilient septum50 therein.Septum50 preferably comprises a generallycylindrical side portion55 and a generallycircular end portion60. Generallycylindrical side portion55 and generallycircular end portion60 are preferably formed integrally from an elastomeric material, such as a silicone elastomer. The outer diameter ofside portion55 is preferably slightly less than the diameter ofseating chamber25.Base member15 preferably further includes aretention member70 to retainseptum50 withinseating chamber25. In the embodiment of FIG. 1,retention member70 extends radially inward (with respect to axis A) around the perimeter ofseating chamber25.
• [0022]Base member15 also preferably includes a mechanism, such as threadedportion75, on an outside wall thereof to form a releasable connection with asecond member100.Base member15 preferably also comprises an extendingmember80 in fluid connection withpassage20 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.Base member15 is preferably fabricated from a relatively rigid polymeric material.
• As illustrated in FIG. 2, the connector of the present invention also comprises second or[0023]male member100.Second member100 comprises a penetratingmember110. Penetratingmember110 comprises a generally cylindrical penetratingelement115 extending from a first end thereof. Apassage120 is formed through penetratingelement115 and the remainder of penetratingmember110. The second end of penetratingmember110 preferably forms an extendingmember122 in fluid connection withpassage120 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached.
• [0024]Second member100 also preferably includes aswivel member125 rotatably connected to penetratingmember110. In the embodiment of FIG. 2,swivel member125 comprises apassage130 through which penetratingmember110 passes. In the embodiment of FIG. 2, penetratingmember110 is rotatably connected to swivelmember125 through the cooperation of anannular depression135 formed in penetratingmember110 and a radially inward extendingflange140 onswivel member125.Swivel member125 preferably further includes a threadedportion145 on an interior surface thereof to cooperate with threadedportion75 offirst member10. Preferably, penetratingmember110 andswivel member125 are fabricated from a relatively rigid polymeric material.
• The cooperation of[0025]first element10 andsecond element100 to form an aseptic connection is illustrated in FIGS. 3A through 3D.First member10 andsecond member100 are first drawn axially together as illustrated in FIG. 3A. As penetratingelement115 pierces flexible septum50 (see FIG. 3B),swivel member125 is rotated relative tobase member15 to engage threadedportions145 and75. As threadedportions145 and75 are tightened, bringingfirst member10 andsecond member100 in closer contact, anabutment shoulder150 of penetratingmember110 exerts axial force uponseptum50. Generallycylindrical side portion55 of septum50 (which preferably has an inner diameter slightly greater than the outer diameter of penetrating element115) is thereby compressed and exerts force generally symmetrically around penetratingelement115 and against the inner wall of seatingchamber25 to create a tight and substantially leak proof seal therebetween. The substantial axial and radial forces upon septum50 (and the resultant seal) enable use of the aseptic connector at relatively high pressures.
• Upon connection of[0026]first member10 andsecond member100,passage20 andpassage120 are in fluid connection to allow flow of a fluid through the aseptic connector. As best illustrated in FIG. 3C, penetratingelement115 is preferably sized such that it does not directly contact any portion offirst member10 other thanseptum50. As penetratingelement115 has been exposed to the exterior environment, contact of penetratingelement115 only withseptum50 assists in preventing cross contamination betweenfirst member10 andsecond member100.Penetrating element115 must also be of sufficient length to extend beyondseptum50 to ensure unobstructed flow throughpassage120.
• As set forth above, threaded[0027]portions75 and145 of first member and second member, respectively, 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 threadedportions75 and145 also acts to maintain the interior of the aseptic connector in an aseptic condition, until disengagement as illustrated in FIG. 3D. Upon disengagement,septum50 substantially prevents leakage of fluid fromfirst member10.
• FIGS. 4 and 5 illustrate another embodiment of an[0028]aseptic connector150 of the present invention.Aseptic connector150 comprises a first orfemale member155 and a second ormale member175.First member155 is preferably generally cylindrical in shape and comprises aseptum160 enclosing one end thereof.First member155 also preferably comprises an extendingmember162 to which a conduit or connector (not shown), such as flexible tubing or a luer connector, can be attached. Extendingmember162 has apassage164 formed therein, which is in fluid connection with an interior166 offirst member155.First member155 also preferably comprises threading170 on an exterior wall thereof.
• [0029]Second member175 comprises a penetratingmember180. Penetratingmember180 comprises a generally cylindrical penetratingelement182 extending from a first end thereof. Apassage184 is formed through penetratingelement182 and the remainder of penetratingmember180. The second end of penetratingmember180 preferably forms an extendingmember186 in fluid connection withpassage184 to which a conduit or connector (not shown), such as flexible tubing or a luer connection, can be attached.
• [0030]Second member180 also preferably includes aswivel member190 rotatably connected to penetratingmember180 as described above.Swivel member190 preferably includes threading192 on an interior surface thereof to cooperate with threading170 onfirst member155.Second member175 also preferably includes opposingwing elements194 extending radially outward therefrom to facilitate rotation ofsecond member175 relative tofirst member155 to form a threaded connection offirst member155 andsecond member175.
• The cooperation of[0031]first member155 andsecond member175 to form an aseptic connection is illustrated in FIGS. 4 and 5. As discussed above in connection withfirst member10 andsecond member100,first member155 andsecond member175 are first drawn axially together. As penetratingelement182 piercesflexible septum160,swivel member190 is rotated relative tofirst member155 to engage threadedportions170 and192. As threadedportions170 and192 are tightened, bringingfirst member150 andsecond member175 into closer contact, aforward surface172 offirst member155 contacts an annular,elastomeric member196 seated in a generally cylindricalinterior chamber198 ofsecond member175. Annular,elastomeric member196 is thereby compressed generally symmetrically around penetratingmember180 and against the inner wall ofswivel member190 to create a tight and substantially leak proof seal between penetratingmember180 and the interior wall ofswivel member190. As discussed above, the substantial axial and radial forces upon annular, elastomeric member196 (and the resultant seal) enable use ofaseptic connector150 at relatively high pressures.
• FIG. 6A illustrates an embodiment of a fluid (for example, contrast media)[0032]delivery system200 incorporating an aseptic connector as described in FIGS. 1 through 3B. As recognized by one skilled in the art,aseptic connector150 of FIGS. 4 and 5 is equally suitable for use influid delivery system200. 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.
• [0033]Delivery system200 preferably includes a disposablepatient interface300 in releasable fluid connection with anoutlet360 of a pumping system, such as a manual or injector-poweredsyringe350. 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[0034]patient interface300 preferably comprises anIV catheter310.IV catheter310 is preferably in fluid connection with acheck valve320 or other suitable means to ensure unidirectional flow of the medium into the patient.Check valve320 is in fluid connection withflexible tubing330. Flexible tubing is preferably in fluid connection with extendingmember122 ofmale member100 of the aseptic connector.
• [0035]Female member10 of the aseptic connector is preferably in fluid connection withpowered syringe350. In the embodiment of FIG. 6A,female member10 is in fluid connection with afirst outlet410 ofdual check valve400 via extendingmember80 offemale member10. Asecond outlet420 ofdual check valve400 is preferably in releasable fluid connection withsyringe350 via, for example, a luer connection.Inlet430 ofdual check valve400 is preferably in fluid connection withfemale member10′ of a second aseptic connector of the present invention via extendingmember80′ thereof.
• [0036]Female member10′ is preferably in releasable fluid connection with a disposable source ofcontrast medium500. In that regard, amale member100′ is preferably in fluid connection with acontrast container505. In the embodiment of FIGS. 6A and 6B,male member100′ is in fluid connection with the first end of a length ofconduit510 via extendingmember122′. The second end ofconduit510 is in fluid connection with aspike520 designed to penetrate a septum (not shown) ofcontainer505, as known in the art.
• During an injection procedure,[0037]plunger355 ofsyringe350 is first drawn rearward (toward powered injector360). The negative pressure created withinsyringe355 causes a valve ofinlet430 ofdual check valve400 to open and contrast medium to flow intosyringe350 fromcontrast container505 viasecond outlet420. Concurrently, the negative pressure withinsyringe350 causes a valve ofsecond outlet410 to remain closed.
• After a desired amount of contrast medium is drawn into[0038]syringe350,plunger355 is advanced forwardly (away from powered injector360) to create a positive pressure withinsyringe350 and thereby inject contrast medium into the patient. The positive pressure withinsyringe350 causes the valve ofinlet430 ofdual check valve400 to close and the valve ofsecond outlet410 to open, thereby allowing the contrast medium to be injected into the patient via disposablepatient interface300.
• As best illustrated in FIG. 6A, the releasable nature of the aseptic connector of the present invention allows[0039]male member100 to be disconnected fromfemale member10 so that disposablepatient interface300 may be discarded, preferably after each injection procedure. The disposable nature ofpatient interface300 assists in preventing cross contamination between patients.
• Likewise,[0040]male member100′ is disconnectable fromfemale member10′.Fluid source500, includingcontrast container505,conduit510 andmale member100′, can thus be discarded whencontrast container505 is emptied.Dual check valve400 can be reused with anew contrast container505 and a newmale member100′ if so desired.
• [0041]Syringe350 can be released fromdual check valve400 so thatsyringe350,dual check valve400 andfemale members10 and10′ attached thereto can be discarded periodically. For example,syringe350,dual check valve400 andfemale members10 and10′ 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. When more than one injection procedure is performed beforedual check valve400 andfemale members10 and10′ are discarded,septums50 and50′ are preferably cleaned using an aseptic technique between procedures by, for example, wipingseptums50 and50′ with alcohol to reduce the likelihood of contamination.
• As also clear to one skilled in the art, configurations other than set forth in FIGS. 6A and 6B are possible. For example,[0042]conduit510 can be connected directly toinlet430 ofdual check valve400 without an intermediate releasable aseptic connection. In that embodiment,container505,conduit510,dual check valve400, andfemale member10 are preferably discarded periodically as a unit. For example, those components may be discarded daily or upon emptying ofcontainer500. Once again,septum50 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.[0043]

Claims (20)

What is claimed is:

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 ofclaim 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 ofclaim 2 wherein the unidirectional flow device comprises a check valve.

4. The fluid delivery system ofclaim 1 wherein the valve device is a dual check valve.

5. The fluid delivery system ofclaim 1 wherein the valve device further defines a first inlet.

6. The fluid delivery system ofclaim 5, further comprising a source of fluid in fluid connection with the first inlet of the valve device.

7. The fluid delivery system ofclaim 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 ofclaim 7 wherein the source of fluid is adapted to be removably connected to the first inlet.

9. The fluid delivery system ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 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 ofclaim 1 wherein the at least one pump system comprises a syringe.

19. The fluid delivery system ofclaim 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 ofclaim 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.

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