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CA1156115A - Injection site with tamper indicator - Google Patents

Injection site with tamper indicator

Info

Publication number
CA1156115A
CA1156115A CA000384250A CA384250A CA1156115A CA 1156115 A CA1156115 A CA 1156115A CA 000384250 A CA000384250 A CA 000384250A CA 384250 A CA384250 A CA 384250A CA 1156115 A CA1156115 A CA 1156115A
Authority
CA
Canada
Prior art keywords
inlet
injection site
tamper indicating
sealing member
frangible
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.)
Expired
Application number
CA000384250A
Other languages
French (fr)
Inventor
Herbert Mittleman
William L. Rush
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.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
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 Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Application granted granted Critical
Publication of CA1156115A publication Critical patent/CA1156115A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members

Landscapes

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

Abstract

ABSTRACT OF THE DISCLOSURE
A tamper indicating device (24) is connected to the inlet (14) of an injection site (10) which inlet (14) in-cludes a pierceable, self-sealing member (16). The tamper indicating device (24) comprises a cap (26, 28) which cov-ers the inlet (14) rendering the pierceable, self-sealing member (16) inaccessible. A first portion (26) of the cap is connected to the inlet (14) and a second portion (28) of the cap is separated from the first portion (26) by a frangible section (30). A handle (32) extends from the second portion (28) and is operable when actuated to break the second portion (28) away from the first portion (26) at the frangible section (30), rendering the pierceable, self-sealing member (16) accessible. The first portion (26) remains connected to the inlet (14) to indicate that tampering has occurred.

Description

~15~

Description Injection Site With Tamper Indicator TECXNICAL FIELD
The present invention concerns an injection site 5 which carries a device for indicating that an injection has occurred or that the injection site has been tampered with.
BACKGROUND ART
Injection sites are commonly used in hospitals where a parenteral fluid is being fed to a patient intravenously and it is also desired to combine another medicament with the parenteral fluid. In such circumstances, the paren-teral fluid is fed via flexible conduit to one inlet of a connecting device, commonly called an injection site. Flex-ible conduit extends from the outlet of the injection siteto an appropriate device for administering the liquid to the patient. The injection site typically has a second inlet, having a pierceable diaphragm connected thereto.
The supplementary medicament is injected into the second inlet by a hypodermic syringe and it becomes combined with the parenteral liquid for administration to the patient.
A type of injection site which comprises the above-de-scribed characteristics is disclosed in Herbert Mittleman U.S. Patent No. 4,000,7~0, issued January 4, 1977, and en-titled "Injection Site".
The pierceable diaphragm is formed of a self-seal-able material, such as Latex or silicone rubber, and it is often impossible to determine whether an injection has been made into the diaphragm by merely viewing it. In addition, since prior art injection sites generally uti-lize pierceable diaphragms which are exposed to ambient 115~1~5 surroundings, it is possible for the pierceable diaphragm to have come in contact with various fluid contaminants without anyone knowing whether such has occurred. Further, if the injection site is not stored properly, a layer of dust may collect upon the pierceable diaphragm.
DISCLOSURE OF THE INVENTION
It is an object of the present invention to provide means for determining whether injection into the pierce-able diaphragm has occurred or whether tampering has oc-curred.
Another object of the present invention is to pro-vide tamper indicating means for an injection site, which also serves to prevent the pierceable diaphragm of the injection site from being contaminated with dust or cer-tain gross contaminants.
Another object of the present invention is to pro-vide an injection site including tamper indicating means that is simple in construction and efficient to manufac-ture.
A still further object of the present invention is to provide tamper indicating means for an injection site, which renders the pierceable diaphragm inaccessible until a portion of the tamper indicating means is removed.
Other objects and advantages of the present inven-tion will become apparent as the description proceeds.
In accordance with the present invention, a tamper indicating device is provided for connection to an injec-tion site having a main body portion, a first inlet, a second inlet including a pierceable, self-sealing member, 30 an outlet, and with the first inlet, second inlet and out-let being in fluid communication with the main body por-tion. The tamper indicating device comprises a cap cover-11 5 ~

ing the second inlet and rendering the pierceable, self-sealing member inaccessible. The cap comprises a first portion for connection to the second inlet and a second portion separated from the first portion by a frangible 5 section. A handle extends from the second portion and is operable when actuated to break the second portion away from the first portion at the frangible section. In this manner, the pierceable, self-sealing member becomes access-ible while the first portion remains connected to the sec-10 ond inlet.
In the illustrative embodiment, the first portioncomprises a ring member substantially encircling the sec-ond inlet. The second portion comprises a cup-shaped mem-ber and the frangible section comprises an annular thin section coupling the first portion to the second portion.
The tamper indicating means has a color that is different from the color of the second inlet so that when the second portion is broken away from the first portion, the color of the first portion which remains connected to the second inlet will contrast with the color of the second inlet, to show that the injection site had a tamper indicating device that has been partially removed.
A more detailed explanation of the invention is pro-vided in the following description and claims, and is il-lustrated in the accompanying drawings.

~15~i5 BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of an injection site with tamper indicating means, constructed in accordance with the principles of the present invention.
Figure 2 is a top plan view of a tamper indicating device constructed in accordance with the prir,ciples of the present invention.
Figure 3 is a cross-sectional elevation thereof, taken along the plane of the line 3-3 of Figure 2.
Figure 4 is a left side elevation of the tamper in-dicating device of Figure 2.
Figure 5 is a cross-sectional elevation taken along the plane of the line 5-5 of Figure 2.
Figure 6 is a perspective view of the injection site of Figure 1, after a portion of the tamper indicating means has been removed.

~5~

DETAILED DESCRIPTION OF
THE IL~USTRATIVE EM~ODIMENT
Referring to Figures 1 and 6 in particular, the in-jection site 10 illustrated therein comprises a first inlet 12 for connection to a tube leading to a parenteral source of liquid, a second inlet 14 (Figure 6) having a pierceable self-sealing diaphragm located therein as is well-known in the art, an outlet 18 for coupling to tubing which is con-nected to a patient, a main body portion 20 with which in-lets 12 and 14 and outlet 18 communicate, and a ridge 22connecting inlets 12 and 14 ~o aid in preventing tubing from becoming caught between these inlets. Such an injec-- tion site is illustrated in a pending Canadian patent appIication in the name of Herbert Mittleman, Serial No.
322,945, filed March 7, 1979. Referring to Figure 6, it can be seen that the top plane of pierceable diaphragm 16 is generally coplanar with the top of second inlet 14.
Inlet 14 is substantially encircled and covered by tamper indicating device 24. Tamper indicating device 24 is formed in a one-piece integral molded construction, and comprises a fir~t portion 26, which is cylindrical with its internal wall being solvent bonded to the external wall of second inlet 14, a second portion 28 which is generally cup-shaped and is separated from first portion 26 by a fran-gible section 30, and a handle 32 which is a generally flatmember extending perpendicular to the axis of cup-shaped second portion 28 (and thus perpendicular to the axis of second inlet 14).
Frangible section 30 comprises an annular thin sec-tion, as most clearly illustrated in Figure 3, with fran-gible section 30 being in general alignment with the top of second inlet 14. For rigidity purposes, i.e., in order to prevent handle 32 from breaking away from second portion 28, a gusset 34 bridging the underside of handle 32 and a ~`

~15~1i5 side of second portion 28 is provided.
One side of tamper indicating device 24 defines arectangular slot 36 (Figure 4) which extends from the bottom 38 of first portion 26 to a level just above the frangible section 30. This slot 36 is of a width to accommodate ridge 22, whereby the first portion 26 will encircle sec-ond inlet 14 except for ridge 22. Slot 36 is such that its top wall 40 is above the plane of the top of inlet 14, thereby providing a small opening so that inlet 14 can be ethylene trioxide sterili~ed notwithstanding the presence of tamper indicating device 24 thereon.
With reference to Figure 1, it can be seen that when tamper indicating device 24 is on second inlet 14, pierce-able diaphragm 16 is inaccessible. In order for pierce-able diaphragm 16 to become accessible, handle 32 is liftedupwardly to break the frangible section 30 so that second portion 28 can be removed from first portion 26. When second portion 28 is removed, the first portion 26 will remain attached to second inlet 14 as illustrated in Fig-ure 6.
The tamper indicating device 24 is formed of a plas-tic having a different color than the color of second in-let 14, so that once handle 32 and second portion 28 are removed, an operator can readily see that a portion of the tamper indicating device 24 has been removed. As an example, although no limitation is intended, the tamper indicating device 24 may be a bright color, such as red, while second inlet 14 may be white.
Although an illustrative embodiment of the inven-tion has been shown and described, it is to be understoodthat various modifications and substitutions may be made by those skilled in the art without departing from the novel spirit and scope of the present invention.

Claims (13)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An injection site having a main body portion, a first inlet, a second inlet including a pierceable self-sealing member, and an outlet, the first inlet, second in-let and outlet being in fluid communication with the main body portion, the improvement comprising:
tamper indicating means connected to said second in-let, said tamper indicating means comprising a cap cover-ing said second inlet and rendering said pierceable self-sealing member inaccessible, said cap comprising a first portion connected to said second inlet and a second por-tion separated from said first portion by a frangible sec-tion, a handle extending from said second portion and oper-able when actuated to break the second portion away from the first portion at said frangible section, with the first portion remaining connected to said second inlet and with the pierceable self-sealing member being accessible.
2. An injection site as described in Claim 1, said first portion comprising a ring member substantially en-circling said second inlet, said second portion comprising a cup-shaped member and said frangible section comprising an annular thin section coupling said first portion to said second portion.
3. An injection site as described in Claim 2, said second inlet including a rigid port having a top, and said annular thin section being in general alignment with the top of said second inlet.
4. An injection site as described in Claim 1, said injection site including a ridge connected between said first and second inlets, said first portion comprising a ring member substantially encircling said second inlet except for the ridge, said second portion defining an open-ing adjacent said frangible section and overlying said ridge for enabling gas sterilization.
5. An injection site as described in Claim 2, said handle comprising a generally flat member extending gener-ally perpendicular to the general axis of said cup-shaped member and formed integrally therewith, and a gusset bridg-ing the underside of said handle and said second portion.
6. An injection site as described in Claim 1, where-in said first portion has a different color from the color of said second inlet.
7. An injection site having a main body portion, a first inlet, a second inlet including a pierceable self-sealing member, and an outlet, the first inlet, second in-let and outlet being in fluid communication with the main body portion, the improvement comprising:
tamper indicating means connected to said second in-let, said tamper indicating means comprising a cap cover-ing said second inlet and rendering said pierceable self-sealing member inaccessible, said cap comprising a first portion connected to said second inlet and a second por-tion separated from said first portion by a frangible sec-tion, a handle extending from said second portion, said handle comprising a generally flat member extending gener-ally perpendicular to the general axis of said second por-tion and formed integrally therewith, a gusset bridging the underside of said handle and said second portion, said second portion being operable when actuated to break the second portion away from the first portion at said fran-gible section, with the first portion remaining connected to said second inlet and with the pierceable self-sealing member becoming accessible, said first portion comprising a ring member substantially encircling said second inlet, said second portion comprising a cup-shaper member and said frangible section comprising an annular thin section coupling said first portion to said second portion, said second inlet including a rigid port having a top, and said annular thin section being in general alignment with the top of said second inlet, said first portion having a dif-ferent color from the color of said second inlet.
8. An injection site as described in Claim 7, said injection site including a ridge connected between said first and second inlets, said first portion comprising a ring member substantially encircling said second inlet ex-cept for the ridge, said second portion defining an open-ing adjacent said frangible section and overlying said ridge for enabling gas sterilization.
9. An injection site as described in Claim 1, where-in said tamper indicating means is formed in an integral one-piece molded construction.
10. A tamper indicating device for connection to an injection site having a main body portion, a first inlet, a second inlet including a pierceable self-sealing member, an outlet, and with the first inlet, said inlet and outlet being in fluid communication with the main body portion, said tamper indicating device comprising:
a cap covering said second inlet and rendering said pierceable self-sealing member inaccessible, said cap com-prising a first portion for connection to said second in-let and a second portion separated from said first portion by a frangible section, a handle extending from said sec-ond portion and operable when actuated to break the second portion away from the first portion at said frangible sec-tion, with the first portion being adapted to remain con-nected to said second inlet and with the pierceable self-sealing member becoming accessible.
11. A tamper indicating device as described in Claim 10, said first portion comprising a ring member adapted to substantially encircle said second inlet, said second por-tion comprising a cup-shaped member and said frangible sec-tion comprising an annular thin section coupling said first portion to said second portion.
12. A tamper indicating device as described in Claim 10, said handle comprising a generally flat member extend-ing generally perpendicular to the general axis of said cup-shaped member and formed integrally therewith, and a gusset bridging the underside of said handle and said sec-ond portion.
13. A tamper indicating device as described in Claim 10, wherein said tamper indicating device is formed in an integral one-piece molded construction.
CA000384250A 1980-10-10 1981-08-20 Injection site with tamper indicator Expired CA1156115A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US19588580A 1980-10-10 1980-10-10
US195,885 1980-10-10

Publications (1)

Publication Number Publication Date
CA1156115A true CA1156115A (en) 1983-11-01

Family

ID=22723224

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000384250A Expired CA1156115A (en) 1980-10-10 1981-08-20 Injection site with tamper indicator

Country Status (4)

Country Link
AU (1) AU7462381A (en)
CA (1) CA1156115A (en)
ES (1) ES269162Y (en)
GB (1) GB2084878B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4632267A (en) * 1984-11-13 1986-12-30 Baxter Travenol Laboratories, Inc. Overmolded port closure
EP0379788A1 (en) * 1988-12-28 1990-08-01 BAXTER INTERNATIONAL INC. (a Delaware corporation) Improved injection site

Also Published As

Publication number Publication date
GB2084878B (en) 1984-02-08
ES269162Y (en) 1984-01-01
GB2084878A (en) 1982-04-21
AU7462381A (en) 1982-04-22
ES269162U (en) 1983-06-16

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Legal Events

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