United States Patent [19J
`Menyhay
`
`[54] STERILE MEDICAL INJECTION PORT AND
`COVER METHOD AND APPARATUS
`
`[76]
`
`Inventor: Steve Z. Menyhay, 9850 N. Willow
`Creek La., Fresno, Calif. 93720
`
`[21] Appl. No.: 390,651
`
`Feb. 17, 1995
`
`[22] Filed:
`Int. CI.6
`[51]
`[52] U.S. CI .
`
`...................................................... A61M 5/00
`............................ 604/256; 604/280; 138/89;
`215/DIG. 3
`[58] Field of Search .................................. 604/27-29, 93,
`604/192, 263, 256, 265, 266, 280, 283,
`905; 138/89, 96 R; 206/206, 207, 363;
`215/DIG. 3
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`D. 342,134 12/1993 Mongeon .
`4,335,756 11/1982 Sharp .
`9/1983 Rosenthal et al. ...................... 604/411
`4,402,691
`4,432,766
`2/1984 Bellotti et al ........................... 604/283
`4,440,207
`4/1984 Genatempo et al. ................. 150/52 R
`4,507,111
`3/1985 Gordon et al ............................... 604/3
`5,190,534
`3/1993 Kendell ................................... 604/905
`
`OTHER PUBLICATIONS
`
`Keegan-Wells, Diane, R. N., M. S. N., et al. The Use of
`Venous Access Devices in Pediatric Oncology Nursing Prac(cid:173)
`tice. Journal of Pediatric Oncology Nursing, vol. 9, No. 4,
`pp. 159-169 (Oct., 1992).
`Long, Charlene M., Ph.D., R. N., et al. Comparative study
`of nursing protocols for venous access ports. Cancer Nurs(cid:173)
`ing, vol. 15, No. 1, pp. 18-21 (1992).
`Poisson, D. M., et al. Electron-microscopic description of
`accretions occuring on tips of infected and non-infected
`central venous catheters. Intesive Care Med, vol. 18, pp.
`464-468 (1992).
`Groeger, Jeffrey S., M. D., et al. ln,fectious Morbidity
`Associated with Long-Term Use of Venous Access Devices
`in Patients with Cancer. Annals of Internal Medicine, vol.
`119, No. 12, pp. 1168-1174 (Dec. 15, 1993).
`
`I 1111111111111111 11111 lllll lllll lllll 111111111111111 11111 111111111111111111
`5,554,135
`Sep. 10, 1996
`
`US005554135A
`[11] Patent Number:
`[45] Date of Patent:
`
`Larson, Elaine, Ph.D., R.N., F.A.A.N., APIC Guidelines For
`Infection Control Practice, Guideline for use of topical
`antimicrobial agents. American Journal of Infection Con(cid:173)
`trol, vol. 16, No. 6, pp. 253-266, (Dec., 1988).
`Marcoux, Charlotte, et al., Central Venous Access Devices in
`Children. Pediatric Nursing, vol. 16, No. 2, pp. 123-133,
`(Mar.-Apr., 1990).
`Forse, R. A., M.D., et al. Staphylococcus epidermidis: An
`important pathogen. Surgery, vol. 86, No. 3, pp. 507-514
`(Sep., 1979) ..
`Sitges-Serra, A., M.D., et al. Catheter sepsis: The clue is the
`hub. Surgery, vol. 97, No. 3, pp. 355-357 (Mar., 1985).
`
`Primary Examiner-Corrine M. McDermott
`Attorney, Agent, or Firm-Mark D. Miller
`
`[57]
`
`ABSTRACT
`
`A unique external injection port cover is provided that is
`open at one end, closed at the other end, and includes a set
`of spiraling screw threads on the inside. It is designed to be
`screwed into place over a specially adapted external injec(cid:173)
`tion port having its own corresponding screw threads. The
`inside of the closed end of the cover includes an inwardly
`pointing projection. A sponge is provided inside the open
`end, and a shatterable plastic capsule containing a combi(cid:173)
`nation - of antiseptic, bactericidal and virucidal agents is
`provided between the sponge and the projection. A flexible
`O-ring seal is provided on the inside of the cover near the
`open end. When the present invention is screwed into place
`over an injection port, the O-ring first creates a seal over the
`end of the port. As the invention is tightened down, the
`pressure between the projection and the breakable capsule
`causes the capsule to rupture thereby releasing the antiseptic
`agents inside to be soaked up by the sponge. When com(cid:173)
`pletely tightened, the antiseptically treated sponge comes
`into contact with the latex membrane of the port, keeping it
`saturated, clean and aseptic until the cover is removed. The
`present injection port cover requires no maintenance when
`not in use resulting in decreased risk of infection and longer
`life of the injection port itself.
`
`22 Claims, 7 Drawing Sheets
`
`BAXTER EXHIBIT 1007
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`U.S. Patent
`US. Patent
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`Sep. 10, 1996
`Sep. 10, 1996
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`Sheet 1 of 7
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`5,554,135
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`U.S. Patent
`US. Patent
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`Sep. 10, 1996
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`Sep. 10, 1996
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`Sep. 10, 1996
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`5,554,135
`
`1
`STERILE MEDICAL INJECTION PORT AND
`COVER METHOD AND APPARATUS
`
`BACKGROUND OF THE INVENTION
`
`5
`
`10
`
`2
`to potential contaminants. These contaminants include, but
`are not limited to, germs, bacteria, air, dirt, clothing, skin
`and perspiration. Injection ports (especially those attached to
`the dangling Broviac® catheter) are also exposed to poten-
`tial trauma and rough handling. Children and other unknow(cid:173)
`ing patients may subject the port to damage from the
`insertion of dirty sharp objects or playthings, chewing on the
`port, etc. Also, exposure of the latex port septum to agents
`such as ozone, oxygen, and ultra violet light can cause the
`latex to break down over time.
`Because of the exposure of the injection port to contami(cid:173)
`nants, the use of an aseptic cleansing procedure is required
`prior to accessing the port for administration of medication.
`Using currently accepted techniques, the cleansing process
`15 alone involves several steps and the use of numerous mate(cid:173)
`rials for each port access. In order to a~sure an aseptic
`environment, a second person is needed to assist the first
`with the cleansing process. This is because the iodine and
`alcohol swabs are sealed inside sterile pouches, the outsides
`20 of which are not sterile. Hence, touching the outside with a
`sterile glove contaminates the glove. The second person
`opens the pouches allowing the first to remove the contents.
`Otherwise, the first person contaminates his/her gloves by
`opening the pouches.
`A typical example of an external injection port access and
`cleansing procedure includes the following time consuming
`steps:
`
`The present invention relates to sterile medical injection
`ports, and more particularly to a new, easy-to-use sterile
`medical injection port and covering apparatus for hospital
`and home use.
`1. Field of the Invention.
`There are many hospital and home care situations where
`prolonged and frequent access to venous circulation is often
`necessary for proper patient treatment. Treatments for
`chronic illnesses, cancer, bacterial infections, AIDS, or those
`in need of parenteral nutrition or blood transfusions often
`require repeated daily or even hourly venous punctures. In
`order to avoid continuous skin punctures in these and other
`situations, medical Venous Access Devices (VADs) and
`injection ports have been developed. VADs are also known
`by such names as atrial catheters, central lines, and central
`venous catheters.
`Presently, there are two basic types ofVADs, (a) Partially
`Implanted Devices (PIDs), and (b) Totally Implanted
`Devices (TIDs). PIDs may be for short term use where one 25
`end of the catheter is inserted into a blood vessel and the
`other end (where the injection port is located) protrudes
`from the skin. PIDs may also be for long term use where a
`catheter is surgically implanted under the skin (under anes(cid:173)
`thesia), usually in the upper abdomen or chest area, to a vein 30
`insertion site. Short term PIDs have been used as long as six
`months; whereas, long term PIDs have been maintained for
`more than 2 years.
`Totally Implanted Devices (TIDs) such as the Mediport®
`generally consist of one end of the catheter inserted into a 35
`deep venous blood vessel. Placement is similar to a long
`term PID. However, the access end of a TID is generally in
`the form of an internal injection port below the surface of the
`skin.
`External injection ports are most commonly used in PIDs. 40
`Existing external port devices (i.e. outside of the skin)
`include a covering membrane or septum which is made of
`thick silicone or latex. Special needles are required to access
`the injection port. Such needles have a sharply beveled tip
`which slices the septum when inserted. When the needle is
`removed, the septum then reseals. External injection ports
`must be periodically replaced after repeated punctures.
`2. Description of the Prior Art.
`The Broviac® catheter (a PID) is a long term small 50
`diameter flexible catheter. The Broviac® includes a length
`of small diameter tubing one end of which is threaded to a
`desired site inside the body, the other end of which (the
`access end) dangles from an external opening in the skin. It
`lies relatively flat against the body after the dressing is in 55
`place, and can easily be coiled and secured with tape. The
`Hickman® catheter (also a PID) has a larger diameter and is
`used when large volumes of blood, medications, and/or
`chemotherapy are administered. Single, double and triple
`access catheters of various sizes are in use in the art.
`Surprisingly, no existing injection port is designed for use
`with a covering for protecting the access port while it is not
`in use. Some ports include screw threads which allow them
`to more easily be connected to IV tubing during lengthy
`accesses. However, most external injection ports normally 65
`remain uncovered and completely exposed to the outside
`world so that the sealed septum membrane is the only barrier
`
`Steps
`
`Equipment
`
`I pair of gloves
`
`1 alcohol swab
`
`I povidone iodine
`swab
`
`I povidone iodine
`swab
`
`I povidone iodine
`swab
`
`I alcohol swab
`
`1 alcohol swab
`
`1 alcohol swab
`
`1. Wash hands
`2.
`Put on sterile gloves
`(RN only)
`3. Assistant opens first
`alcohol swab package
`4. RN wipes injection port
`with alcohol
`5. Assistant opens first
`povidone iodine swab
`6. RN takes swab and wipes
`injection port with it
`7. Assistant opens second
`povidone iodine swab
`8. RN takes swab and wipes
`injection port with it
`9. Assistant opens third
`povidone iodine swab
`10. Wait 30 seconds after
`third iodine wipe
`11. Assistant opens first
`alcohol swab
`12. RN takes swab and wipes
`injection port with it
`13. Assistant opens second
`alcohol swab
`14. RN takes swab and wipes
`injection port with it
`15. Assistant opens third
`alcohol swab
`16. RN takes swab and wipes
`injection port with it
`17. Access port; administer
`medication
`18. Leave injection port
`dangling and exposed
`
`Then, as soon as the port is released, it will come into
`contact with the patient's skin or clothing and immediately
`become dirty again, making the above procedure necessary
`the next time the port is accessed. These cumbersome
`techniques and materials are required because of the poor
`design of the current art. In a hospital or clinic setting,
`trained nurses generally perform the procedure. However,
`
`45
`
`60
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`5,554,135
`
`3
`despite having the best of intentions and necessary training,
`the pressures of the moment, combined with occasional
`unavailability of the required medical supplies or personnel
`(e.g. only I alcohol swab instead of 3, no assistant available,
`etc.) can result in missed steps or failure to follow proper 5
`procedures.
`The cleansing procedure, if properly followed, is very
`time consuming. Materials must be gathered prior to access,
`and an assistant must be available before the procedure can
`be started. Then, the procedure itself, as outlined above, 10
`requires careful and strict performance of a long series of
`time consuming aseptic steps, and results in a messy accu(cid:173)
`mulation of used swabs and stains when the procedure is
`completed.
`In a home setting, rigorous and extensive training of the 15
`involved family members is required. They must understand
`the principles of aseptic technique and catheter safety, as
`well as the specific tasks of dressing changes, changing
`injection ports, and emergency measures. Even with such
`training, these steps can seem complicated to the ordinary 20
`user resulting in missed or poorly performed steps which can
`compromise asepsis, thereby increasing the risk of infection.
`The more frequent the access, the greater the risk. Often,
`home care providers will erroneously conclude that if the
`injection port was cleaned once early in the day, it need not 25
`be cleaned again that day, or a lesser cleansing procedure is
`required for subsequent accesses that day. In other situa(cid:173)
`tions, the very condition for which the patient is being
`treated (e.g. AIDS, cancer, etc.) places them at greater risk
`of infection and death, making the need for asepsis of 30
`paramount importance.
`An average cost to a hospital for a pair of sterile gloves
`is in the range of three dollars. An average home care cost
`for sterile gloves is usually higher, in the range of five
`dollars per pair. An average hospital cost for a box of 35
`isopropyl alcohol wipes is in the range of two dollars. An
`average home care cost for the same box again is higher,
`usually in the range of twelve dollars. An average hospital
`cost for a box of povidone iodine pads is in the range of three
`dollars. An average home care cost for the same box is
`higher, usually in the range of twenty dollars.
`Thus, an average hospital cost (materials only, not labor)
`of sterile supplies for each injection port access may be in
`the range of seven dollars ($7.00) per access. Multiple daily 45
`accesses compound and increase these costs even more.
`Every external injection port must be accessed at least once
`a day for the application of heparin to prevent clotting. The
`costs of such materials for home care services are generally
`much higher, as set forth above, and can easily be double or 50
`triple the hospital costs. Thus, on a typical multiple access
`day, a home care provider may spend well over thirty dollars
`($30.00) simply for materials to clean and access the dirty
`dangling injection port.
`Recent scientific studies have concluded that the external 55
`injection port, sometimes called the catheter hub, is the place
`of origin of bacteria infecting catheter tips. These studies
`recommend that manipulation of the hub be kept at a
`minimum, and that a more rigorous approach to aseptic
`technique be undertaken. However, as described above, 60
`these are time consuming, expensive and difficult measures.
`One study suggests that the hub be properly covered. How(cid:173)
`ever, this study fails to propose any cover design, and
`instead simply indicates that new designs are needed to
`assure better protection against environmental soiling.
`All external injection ports should have protective cov(cid:173)
`erings in order to maintain the aseptic integrity of the port
`
`40
`
`65
`
`4
`and medical tubing, and to reduce the risk of infection or
`other complications stemming from unwanted external envi(cid:173)
`ronmental factors. However, despite this great need, no
`suitable cover has ever been developed.
`
`SUMMARY OF THE INVENTION
`
`The present invention overcomes many of the drawbacks
`and avoids much of the cost associated with cleaning present
`external injection port devices by providing a unique exter(cid:173)
`nal injection port cover. The cover is open at one end, closed
`at the opposite end, and includes spiraling screw threads on
`the inside. The inside of the closed end includes an inwardly
`pointing projection. A shatterable plastic capsule containing
`a combination of antiseptic, bactericidal and virucidal agents
`is provided inside the cover immediately adjacent to the
`projection. A sponge is provided inside the cover next to the
`capsule on the side opposite from the projection. A flexible
`annular ring (O-ring) is provided on the inside of the cover
`near the open end. The cover is designed to be screwed into
`place over a specially adapted external injection port having
`its own corresponding screw threads.
`As the screw threads of the present invention are tight(cid:173)
`ened over the injection port, the O-ring first creates a seal
`over the end of the port. Then, as the tightening continues,
`the pressure between the inwardly pointing projection and
`the capsule causes the capsule to break, releasing the anti(cid:173)
`septic agents to be soaked up by the sponge. When the
`tightening is complete, the antiseptically treated sponge is in
`contact with the latex membrane of the port, keeping it
`bathed and in a clean and aseptic condition until the cover
`is removed.
`Upon removal, ·since the surface of the port is already in
`an aseptic condition, there is no need to follow lengthy
`cleansing procedures or utilize expensive cleansing materi(cid:173)
`als to access the injection port. Thus, the need for sterile
`gloves, alcohol swabs, iodine swabs, and/or an assistant are
`eliminated. After access, the used cover is discarded and a
`new one is taken from a sealed sterilized package and
`screwed into place over the injection port to again assure that
`the port remains in a clean and aseptic condition.
`These simple and straight forward steps can be easily
`followed by a nurse, home care provider, or family member
`with little chance for mistakes, thereby assuring a safer and
`cleaner environment for the injection port.
`It is therefore a primary object of the present invention to
`provide a unique protective covering for use on an external
`injection port that will help keep the surface of the port in a
`aseptic condition while covered.
`It is a further important object of the present invention to
`provide a protective covering for an external injection port
`that will help prevent contamination of the port from the
`outside.
`It is a further important object of the present invention to
`provide a protective covering for an external injection port
`that eliminates the need for following strict and complicated
`cleansing procedures every time the port is accessed.
`It is a further important object of the present invention to
`provide a protective covering for an external injection port
`that eliminates the need for using sterile gloves, iodine
`swabs, and alcohol swabs every time the port is accessed.
`It is a further important object of the present invention to
`provide a protective covering for an external injection port
`that eliminates the mess created by using sterile gloves,
`iodine swabs, and alcohol swabs every time the port is
`accessed.
`
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`

`5,554,135
`
`6
`provides a continuous aseptic immersion (bathing) of the
`injection port.
`It is a further object of the present invention to provide the
`combination of an injection port and cover device that helps
`reduce the risk of infection of the patient using the port.
`Additional objects of the invention will be apparent from
`the detailed descriptions and the claims herein.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`5
`
`FIG. 1 is an exploded partially cut away perspective view
`of the external injection port covering of the present inven(cid:173)
`tion.
`FIG. 2 is an exploded partially cut away perspective and
`15 diagrammatic view of an external injection port catheter, and
`the covering of the present invention.
`FIG. 3 is a partially cut away side view showing the cover
`and port of the present invention after the cover has been
`tightly screwed over the port and the antiseptic capsule
`ruptured.
`FIG. 4 is a side cutaway view of the external injection port
`cover of the present invention without the capsule or sponge
`inside.
`FIG. 5 is a side cutaway view of the external injection port
`cover of the present invention with the capsule and sponge
`inside.
`FIG. 6 is a perspective view of a specially adapted port
`having hexagonal sides for use with the cover of the present
`invention.
`FIG. 7 is a perspective view of a prior art injection port.
`
`30
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`35
`
`40
`
`50
`
`5
`It is a further object of the present invention to provide a
`protective covering for an external injection port that is
`simple, fast, and easy-to-use, especially in home care situ(cid:173)
`ations.
`It is a further object of the present invention to provide a
`protective covering for an external injection port that helps
`protect the port from puncture or trauma from outside
`objects or forces.
`It is a further object of the present invention to provide a
`protective covering for an external injection port that pro- 10
`motes a clean injection port environment and provides an
`extra barrier to contamination of the port by germs, bacteria,
`and the like.
`It is a further object of the present invention to provide a
`protective covering for an external injection port that pro(cid:173)
`vides a continuous aseptic immersion (bathing) of the injec(cid:173)
`tion port.
`It is a further object of the present invention to provide a
`protective covering for an external injection port that helps 20
`reduce the risk of infection of the patient using the port.
`It is a further object of the present invention to provide a
`fast, easy and low maintenance method of accessing an
`injection port in a aseptic manner.
`It is a further object of the present invention to provide a 25
`simple and low cost method and apparatus for protectively
`covering an external injection port.
`It is a further important object of the present invention to
`provide the combination of an injection port and cover
`device that will help keep the surface of the port in an aseptic
`condition while covered.
`It is a further important object of the present invention to
`provide the combination of an injection port and cover
`device that will help prevent contamination of the port from
`the outside.
`It is a further important object of the present invention to
`provide the combination of an injection port and cover
`device that eliminates the need for following strict and
`complicated cleansing procedures every time the port is
`accessed.
`It is a further important object of the present invention to
`provide the combination of an injection port and cover
`device that eliminates the need for using sterile gloves,
`iodine swabs, and alcohol swabs every time the port is 45
`accessed.
`It is a further important object of the present invention to
`provide the combination of an injection port and cover
`device that eliminates the mess created by using sterile
`gloves, iodine swabs, and alcohol swabs every time the port
`is accessed.
`It is a further object of the present invention to provide the
`combination of an injection port and cover device that is
`simple, fast, and easy-to-use, especially in home care situ(cid:173)
`ations.
`It is a further object of the present invention to provide the
`combination of an injection port and cover device that helps
`protect the port from puncture or trauma from outside
`objects or forces.
`It is a further object of the present invention to provide the
`combination of an injection port and cover device that
`promotes a clean injection port environment and provides an
`extra barrier to contamination of the port by germs, bacteria,
`and the like.
`It is a further object of the present invention to provide the
`combination of an injection port and cover device that
`
`Referring to the drawings wherein like reference charac(cid:173)
`ters designate like or corresponding parts throughout the
`several views, and referring particularly to FIGS. 1 and 2, it
`is seen that the invention includes a cylinder 10 that is open
`on one end, having a set of screw threads 15 on the inside
`thereof. An inwardly pointing projection 13 is provided on
`the inside of cylinder 10 at the closed end. A rubberized
`annular O-ring 14 is provided at or near the open end of
`cylinder 10.
`A breakable capsule 11 is disposed inside cylinder 10
`immediately adjacent to projection 13 (see FIG. 5). A small
`sponge 12 is provided inside cylinder 10 next to capsule 11
`on the side opposite projection 13. Capsule 11 is filled with
`a solution containing povidone iodine and isopropyl alcohol
`(an antiseptic, bactericidal and virucidal solution). Capsule
`11 is made of a breakable plastic material so that it will
`rupture when it is pressed firmly against projection 13.
`External injection port 19 includes a thick septum 18
`made of resealable latex material. A set of screw threads 17
`55 are provided on port 19 which match up with screw threads
`15 on cover 10 so that port 19 may be easily screwed into
`cover 10 (much like a bolt into a nut). Catheter 25 is attached
`to the port and leads back to the body of the patient.
`When the present invention is screwed into place over the
`injection port, O-ring 14 first creates a seal over the end of
`the port 19 (see FIG. 3). As the invention is tightened, the
`pressure between projection 13 and breakable capsule 11
`causes the capsule to rupture thereby releasing the antiseptic
`agents inside to be soaked up by sponge 12. Grooves 9 on
`the inside of cylinder 10 act as channels that allow the
`antiseptic agents escaping from ruptured capsule 11 to flow
`around the capsule and soak into sponge 12. When com-
`
`60
`
`65
`
`BAXTER EXHIBIT 1007
`Page 11 of 13
`
`

`

`5,554,135
`
`5
`
`7
`pletely tightened, the antiseptically treated sponge 12 comes
`into contact with the latex membrane 18 of the port, asep(cid:173)
`tically bathing the port until the cover is removed.
`The present invention can be used not only to cover but
`also to aseptically cleanse the surface of an injection port
`simply by being firmly attached thereto. The cover of the
`present invention should be placed on the injection port
`during the surgical placement of the catheter, and replaced
`every time the port is either accessed or replaced. The
`following illustrates a typical procedure using the present 10
`invention:
`I. Wash hands.
`2. Open sterile envelope containing new sterile replace-
`ment cover, leaving cover inside but easily accessible. 15
`3. Unscrew old cover from port and discard.
`4. Access port; administer medication.
`5. Remove new cover from envelope and screw firmly
`into place over port.
`Note that the extra person and the extra steps of applying 20
`sterile gloves, using iodine swabs, and using alcohol swabs
`are not needed. There is none of the mess associated with
`iodine stains, or the disposal of many wrappers and swabs.
`The procedure is extremely simple, straight forward and
`easy-to-follow, thereby promoting fewer mistakes and 25
`reducing the risk of infection.
`A prior art port and hub is shown in FIG. 7. This hub
`includes an access port 32, a hub housing 30 and a set of
`internal screw threads 31 which allow the hub to be attached
`to the female end of a luer lock of an existing Broviac® or 30
`Hickman® catheter. Tube 34 attaches the hub to such a
`catheter 25.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`35
`
`In the preferred embodiment, the cylindrical cover cap of
`the present invention is made of lightweight rigid non(cid:173)
`porous plastic such as polynylon. The outer edges of the
`cylinder may be smooth, hexagonal, octagonal, ridged, etc. 40
`The cylinder may be of various sizes and lengths depending
`upon the port to which it is to be attached. The annular
`O-ring should be made of a durable, sealable, flexible
`rubberized material such as fluorosilicone. The projection
`inside the cover should be large enough and sufficiently 45
`pointed to cause the capsule to break when the capsule is
`pressed against it. The capsule itself should be small enough
`to fit snugly inside the cover, and be made of a thin-layered
`brittle plastic (such as acrylic) that can be sealed in order to
`hold the fluid of the antiseptic, but which will rupture under 50
`nominal pressure. It should not be made of glass. The sponge
`should be small enough to fit inside the cover, and should
`have an absorption capacity roughly equal to or slightly less
`than the volume of fluid contained in the capsule. The
`sponge should be porous, but firm enough to transmit 55
`pressure to the capsule.
`The helical screw threads can be of any size that is small
`enough to allow at least two complete circuits, thereby
`assuring a tight seal. The outside of the cover should be
`easily gripped, and is hexagonal in the preferred embodi- 60
`ment; however, it could also be rectangular, octagonal,
`rounded with ridges, etc. The outside of the corresponding
`port should be the same as the cover so that the two screw
`together into a single lightweight unit. The circumference of
`the inside of the cover should be slightly larger than the 65
`circumference of the stem of the port; and the circumference
`of the inside of the O-ring should be slightly narrower than
`
`8
`the circumference of the stem of the port in order to effect
`a good seal. The septum of the port should be made of a thick
`latex material.
`It is to be understood that variations and modifications of
`the present invention may be made without departing from
`the scope thereof. It is also to be understood that the present
`invention is not to be limited by the specific embodiments
`disclosed herein, but only in accordance with the appended
`claims when read in light of the foregoing specification.
`I claim:
`1. A method for covering and aseptically cleansing an
`external injection port with membrane comprising the steps
`of:
`a. attaching a closed-ended hollow cylindrical cover over
`said port, said cover having an internal bore with
`helical screw threads therein, a projection on the inside
`at the end thereof, a capsule containing antiseptic
`material and a pad of absorbent porous material dis(cid:173)
`posed therein, and an annular rubberized seal for air-
`tight attachment to said port;
`b. screwing said cover over said port so that said capsule
`is pressed against said projection such that said capsule
`ruptures thereby releasing said antiseptic material onto
`said pad; and
`c. tightening said cover over said port so that said pad of
`antiseptic material comes into contact with the mem(cid:173)
`brane of said port creating a closed aseptic environ(cid:173)
`ment.
`2. The method described in claim 1 wherein said antisep(cid:173)
`tic material is channeled to said pad through a plurality of
`grooves provided on the inside of said cover surrounding
`said capsule.
`3. A protective cover for an external injection port com(cid:173)
`prising:
`a. a hollow cylindrical housing having an opening in the
`form of a bore on one end thereof said opening having
`a set of helical screw threads on the inside thereof, a
`closed opposite end, a projection on the inside of said
`closed end, and an annular rubberized seal on the inside
`of said bore at the open end;
`b. a pad of absorbent porous material disposed inside said
`bore; and
`c. a breakable sealed capsule disposed inside said bore
`between said projection and said pad, said capsule
`containing antiseptic material.
`4. The cover described in claim 3 wherein said annular
`rubberized seal creates a closed environment inside said
`housing when placed over an injection port.
`5. The cover described in claim 3 wherein the helical
`threads of said bore correspond to the threads of an injection
`port.
`6. The cover described in claim 3 wherein the antiseptic
`material contained in said capsule is comprised of at least
`one material selected from the group including povidone
`iodine and isopropyl alcohol.
`7. The cover described in claim 3 wherein said capsule is
`made of a brittle breakable material that