Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/ testing blood, and devices for performing such methods.

(54) Title: METHODS FOR CLEANING DUCT AND INTRAVASCULAR PORT AND METHODS FOR ADMINISTERING AN AGENT INTRAVASCULARLY, METHODS FOR OBTAINING / EXAMINING BLOOD, AND DEVICES FOR PERFORMING SUCH METHODS.

(54) Title: INTRAVASCULAR LINE AND PORT CLEANING METHODS, METHODS OF ADMINISTERING AN AGENT INTRAVASCULARLY, METHODS OF OBTAINING / TESTING BLOOD, AND DEVICES FOR PERFORMING SUCH METHODS.

(57) Summary

An intravascular port access device includes a first component that has a chamber configured to reversibly attach to an intravenous line port. A second component reversibly binds to the first component and contains a disinfecting agent and an applicator material. The second component is configured to be reversibly received on external surfaces of the intravenous line port. One method of cleaning an intravenous line port includes providing a port cleaning device having a first component with a chamber containing a first cleaning agent. A second component includes a second cleaning agent. A third component has a microbicidal agent and reversibly binds to the first component. The second component is removed from the device, the outer surfaces of the port are contacted by the second cleaning agent, the first cleaning agent is ejected from the chamber within the port, and the third component is used to seal the port.

(57) Abstract

An intravascular port access device ineludes a first component having a chamber configured to attach reversibly to an intravenous Une port. A second component reversibly attaches to the first component and contains a disinfecting agent and an applicator material. The second component is configured to be reversibly received over external surfaces of the intravenous Une port. A method of cleansing an intravenous Une port ineludes providing a port cleaning device having a first component with a chamber containing a first cleaning agent. A second component ineludes a second cleaning agent. A third component has a microbiocidal agent and is reversibly attached to the first component. The second component is removed from the device, the external surfaces of the port are contacted with the second cleaning agent, the first cleaning agent is ejected from the chamber into the port, and the third component is used to cap the port.

IMPIC> ·> 8> 1

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PATENT TITLE No. 355490

Owner (s): HYPROTEK, INC.

Address: 4219 E. 65th Avenue, Spokane, Washington, 99223-1806, USA

Name: INTRAVASCULAR PORT AND DUCT CLEANING METHODS AND METHODS FOR ADMINISTERING AN AGENT INTRAVASCULARLY, METHODS FOR QBfENE ^ / ^ XAMJNAR BLOOD, AND DEVICES FOR

Classification:

Inventor (s):

PERFORM SUCH METHODS.

CIP: A61M39 / W; A61M39 / 16^! .

CPC: A61B90 / 70; A61M39 / 2®; A64M2209 / 06: Y10T29 / 49861

PATRICK O. TENNIGAN. '”“ * 3 ^ 0: ·' • ............. V. '' bSAat.'CL ** ·. &lt;i

Number:

MX / a / 2013/001851

<img file="MX355490B_D0002.tif" />

International:

2007

Country:

US US

Validity: Twenty years

Date of Ven $ t «Mif nto: &lt;Je tnaye'de &lt;

Exp. Date: 19 of 3ftWL $ g,; 2Í) Í8

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Number:

60/7 &lt;f, 606

60/641/194 x * ***, ·

The reference patent was granted on the basis of the a. (Íicuíóé T^&amp;/ ^ Wc / »íón V, 6 ° frat ^ QQ [II, ¡rs ^ ds ^ i Industrial Property Law.

In accordance with article ^ 3'clelajtiey of the IfNlustfai Property, Wpws ^ nte {fajente has a validity of twenty additional years, counted from the date of filing of the iptémacional application and will be if ^ te¡ái payment defaianifa.paí ' awnanteripr current rights.

The person who signs the present title did so with the provision of the protoart culote 6 ° JajQones III and? ° 'br9'2, of the Industrial Property Law (Official Gazette of the Federation (DOF) 06/27/1991, amended on 02 / 08/1994 ,,, 16/10/1998, 26®2Π097, 05/17/1999, 01/26/2004, 06/16/2005, 01/25/2006, 06/05/2009 / 06/01 / 2010,18 / 06 ^ ¾ ^ ¾ ^ ¾) artieuWn ?. 3rd fraction: V¡nciso a), 4th and 12th fractions I and III of the Regulations of the Mexican Institute of the (Mpiedaü Mdostiai (BXL ^ .4 $ 1 ^ 1j¡ | 99, r $ * ñg¡ ^ «f_M / 07 ^ p02, 07/15/2004, 07/28/2004 and 09/07/2007); articles 1st, 3rd, 4th, 5th fraction V subsection a), 16 fraeciorrasd · y, dl y, ^ dol bst ^ ttd ^ f ^ MBÉS / lf ^^ Mexican Industrial Property Law (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, O4 / 88 / l (04tr13 / 08 ^ 807). 4 ^ 3 * and iHí ^^ dl-ddrAgreement that delegates powers to the Directors Deputy Generals, Coordinator, Divisional Directors, Titulaos de jad TO regional offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Proficiency. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007).

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 fraction III, 2 fraction V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

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DIVISIONAL DIRECTOR OF PATENTS NAHANNY CANAL REYES

Original string:

NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Servlclode Administración

Tax it | 1695 || MX / 2018/33508 | MX / a / 2013/001851 | Normal patent title with divisional PCT | 1223 | GAGV | Page (s)

2 | bl2xTzf03a2XG8QOucbb9uweMOg =

Digital stamp:

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W¡3jf4K4mdOSIWhKsmSJczTpEt / tt¡jmZh6hOSL¡Op6FQj1uU57bcLpuBPtmuty1OxyeroneVqFIOqKelYOF32SKbC

WrJdGATVywayySZV9Vqsxnly4bUPg5au¡Lp4cPpZuV6o + PdAmLUUU / 4xYq9Gfwu3VCelx¡Pg ==

Additional information on reverse

Arenal No. 550. Floor 1, Pueblo Santa María Tepepan, Xochimilco, 16020, Mexico City, (55) 53340700 www.gob.mx/impi

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MX / 2018/33508

Continuation Pri ridad s

Country:

US

US

Sheet:

March 2007 May 8, 2007

No. r:

60/895,621

11 / 745,843 zz t

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INTRAVASCULAR PORT AND DUCT CLEANING METHODS Ϋ METHODS FOR ADMINISTERING AN AGENT INTRAVASCULARLY, METHODS FOR OBTAINING / EXAMINING BLOOD, AND DEVICES FOR PERFORMING SUCH METHODS

TECHNICAL FIELD

The invention relates to intravascular port access devices, intravascular port cleaning devices, methods for cleaning an intravascular port, methods for administering an agent to an intravascular duct port, methods for obtaining a blood sample from an individual, and assemblies. of intravascular duct port covers.

BACKGROUND OF THE INVENTION

Intravenous lines, such as peripheral IV lines and central IV lines, are common intravenous access methods for administering medications, nutritional solutions, blood products, or other substances into a vein. Arterial ducts are used, for example, to monitor physiological parameters per arterial blood sample during coronary, intensive, or critical care. However, colonization or infection of the intravascular device by microorganisms can occur as a result of its own • X • f'tvr '

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MLXiCaa INSTITUTE ·. Dt LA t'HO,&gt; «CU INOUTA,., Endogenous flora of the patient or of microorganisms introduced from contaminated equipment or other sources of environmental contamination. As a result, a localized or systemic infection or sepsis can occur and can be fatal.

The introduction of microorganisms into an intravenous line can be initiated or facilitated during the handling of a catheter, a concentrator, an associated tube, an injection equipment or ports, especially during the manipulation of the lines in the preparation and during the initiation of the inward fluid delivery or removal from the duct. Microorganisms present on a surface of an injection port can be introduced through the port during administration. Microorganisms present in contaminated equipment used for administration can enter through the port causing colonization or infection. Bacterial growth and / or aggregation in a port or catheter can serve as the nest for coagulation, embolization, and / or occlusion of the port or catheter. Further manipulation or administration through the port may facilitate the dispersal of microorganisms within the port, catheter, and conduits, and ultimately within the patient's vein / artery and / or around the tissue. Therefore, it would be advantageous to develop cleaning methods and devices.

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INDUSTRIAL _ · --of external surfaces of intravascular access ports and / or internal port areas to reduce risks of colonization and infection.

Another complication that can occur in association with an intravascular conduit, catheter, or access port is the formation of clots due to the return of blood. Initial clot formation could extend and / or embolize within the superior vena cava and / or the right atrium and / or the right ventricle of the heart, and subsequently within the pulmonary system that circulates to the lungs. It may be advantageous to develop a methodology and devices to deliver clot-dissolving agents or clot inhibitors through the intravascular ports to minimize or eliminate coagulation associated with the intravascular port.

Still another problem that can be associated with intravascular conduits is lipid accumulation or increase within the conduit or port. It may be advantageous to develop a methodology and devices to deliver lipolytic agents through intravascular ports to minimize or eliminate lipid accumulation associated with the port.

SUMMARY OF THE INVENTION

In one aspect, the invention relates to a

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intravascular port access device. The device includes a first component that has a chamber and is configured to reversibly attach to an intravenous line port. The second component reversibly binds to the first component and contains a disinfecting agent and applicator material selected from the group consisting of a polyethylene felt sponge, a polyethylene foam sponge, a plastic foam sponge, and a foam foam sponge. silicon. The second component is configured to be reversibly received on the eternal surfaces of the intravenous line port.

In one aspect, the invention encompasses an intravascular duct port cleaner including a syringe barrel having a first end and a second end. A sliding piston is received into the cylinder through the second end. The duct port cleaner includes a first cap containing a cleaning agent and a second cap containing a microbicidal agent.

In one aspect, the invention encompasses a method of cleaning a port of the intravenous line. The method includes providing a port cleaning device comprising a first component having a chamber with a first cleaning agent. A second component includes a second cleaning agent. A third component has a

<img file="MX355490B_D0007.tif" />

INSTITUTO MEXICANO r&gt; F the industrial property microbicidal agent and reversibly binds to the first component. The method includes removing a second component from the device, contacting the outer surfaces of the port with the second cleaning agent, injecting the first cleaning agent from the chamber into the port, removing the third component from the device, and seal the port with the third component.

In one aspect, the invention encompasses a method of obtaining a blood sample from an individual. The method includes providing a port access device having a first component including a chamber, a second component containing a cleaning agent, and a third component comprising a microbicidal agent. The third component is reversibly attached to the first component. The method includes removing the second component from the device and contacting the outer surfaces of the port with the cleaning agent. The method further includes drawing blood from the individual through the port within the first component chamber by removing the third component from the device and sealing the port with the third component.

In one aspect, the invention includes an intravascular conduit port cover assembly. The cap assembly includes a first port cap containing a first agent and a first applicator material. Set

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INDUSTIUAÍ also includes a second port cover that contains a second agent and a second applicator material.

BRIEF DESCRIPTION OF THE DRAWINGS

The preferred embodiments of the invention are described below with reference to the following accompanying drawings.

Figure 1 is a schematic isometric view of a device according to an aspect of the invention.

Figure 2 is a schematic side view of the device shown in Figure 1.

Figure 3 is a schematic exploded view of the device shown in Figure 1.

Figure 4 is a schematic cross-sectional view of the device shown in Figure 1.

Figure 5 is a schematic cross-sectional view of the device shown in Figure 1 after repositioning relative to the position described in Figure 4.

Figure 6 is a schematic isometric view of a device according to another aspect of the invention.

Figure 7 is a schematic side view of the device shown in Figure 6.

Figure 8 is a schematic exploded view of the device of Figure 6.

<img file="MX355490B_D0009.tif" />

Figure 9 is a schematic cross-sectional view of the device shown in Figure 6.

Figure 10 is a schematic view of an exemplary packaging concept for the device shown in Figure 6.

Figure 11 shows a multi-pack packaging concept for the device shown in Figure 6.

Figure 12 is a schematic exploded view of a device according to another aspect of the invention.

Figure 13 is a schematic cross-sectional view of the device shown in Figure 12.

Figure 14 is a schematic exploded view of a device according to another aspect of the invention.

Figure 15 is a schematic exploded view of a device according to another aspect of the invention.

Figure 16 is a schematic cross-sectional view of the device shown in Figure 15.

Figure 17 is a schematic isometric view of a packaging concept in accordance with one aspect of the invention.

Figure 18 is a schematic isometric view of the packaging concept shown in Figure 17.

IMPI

MEXICAN INSTITUTE OF INDUSTRIAL rMOFIEDAP

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Figure 19 is another schematic isometric view of the packaging concept shown in Figure 17.

Figure 20 is a schematic isometric view of a set of components in accordance with one aspect of the invention.

Figure 21 is an exploded view of the set of components represented in Figure 20.

Figure 22 is a schematic exploded view of a packaging concept in accordance with one aspect of the invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES

In general, the invention includes devices and a methodology for cleaning and / or accessing the intravascular duct ports. In particular applications, devices of the invention can be used to clean external surfaces of a port of the intravascular duct followed by cleaning the port itself and in particular cases cleaning of intravascular ducts.

In other applications, the devices of the invention can be used to administer an agent intravascularly. During these applications, the devices according to the invention can typically be used to clean external surfaces of the port before using the device for administration of a

<img file="MX355490B_D0011.tif" />

IMPI

INSTITUTO MEXICANO OE LA FROFIEDAD industrial agent intravascularly. In another application, the devices of the invention can be used to obtain a blood sample from an individual. A device in accordance with the invention is typically used to clean external surfaces of a port before using the device to withdraw a blood sample from the port. The invention also includes a methodology for such administration of the port cleaning agent and blood sampling techniques.

In one embodiment, the device comprises two components. An exemplary two-component device is described, with reference to Figures 1-5.

Referring initially to Figure 1, a port access device 10 comprises a first component 12 at a first end 14 of the device, and a second component 16 at a second end 18 of the device. The second component 16 may have a tab 20 or other extension feature to aid removal of the second component from the first component. The first component 12 has a chamber housing 22 which may be a collapsible housing. The first component 12 may also comprise an extension portion 24. Referring to Figure 2, as described, device 10 may have a second portion 16 insertable within connector portion 24. Must be

IMPI

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However, it should be understood that the invention contemplates other configurations where the second portion 16 fits over or seals the extension portion 24. It will also be understood that the shape and dimension of the collapsible housing 22 is further exemplary with alternative shapes, sizes and configurations contemplated.

Referring to Figure 3, which shows an exploded view of the device described in Figures 1 and 2. As illustrated, camera housing 22 of device 10 can house camera 23. Connector 24 may comprise a spacer. 25 having an opening 29 which passes through it. Connector 25 may further comprise a receiving port 30 for receiving a dispenser 26. Dispenser 26 in turn may comprise a valve portion 28. The second component 16 may comprise a receptacle 21.

Referring next to Figure 4, which shows dispenser 26 with valve 28 seated within receiving port 30. As described, such a valve mechanism is in the closed position where the contents of chamber 23 are blocked from passing into or through connector 24. Referring next to Figure 5, the application of force on the collapsible housing 22 such as top-down pressure to an upper surface of the housing can be used to displace the

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INSTITUTO MtXICANt Dfc U \ INDUSTRIAL PROPERTY

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valve device 28 on receiving port 3 0 as illustrated. Such displacement can allow the contents of the chamber 23 to pass into or through the connecting portion 24.

As described in Figure 4, the second component 16 may contain an applicator material 32. Such an applicator material may be, for example, a sponge or a sponge-like material. Exemplary sponge-like materials may include, but are not limited to, polyethylene felt sponge, polyethylene foam sponge, plastic foam sponge, and silicon foam sponge.

In the case where the device is to be used for port cleaning applications, the container 21 of the second component 16 will typically contain a cleaning agent. The cleaning agent can be a disinfecting agent to clean external port surfaces. The agent is not limited to a particular cleaning or disinfecting agent and may comprise, for example, alcohol, preferably contained in an alcoholic solution comprising from about 5% to about 99% alcohol. In particular applications, the alcoholic solution will comprise 25% to 90% alcohol. The sponge-like applicator material can be used to aid in the containment of the cleaning agent and may further aid in the application of the agent to the external surfaces of the intravascular port. The second

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INSTIM IV MEXICANO DE LA EKÜEItDAL '

INDUS'f K1AI component 16 is removably attached to device 10. To clean the port, removable component 16 is removed from first component 12 and is used to contact the external surfaces of the port for cleaning external portions of a port in the intravascular duct.

After cleaning the outer portions of the port, the first component of the device, which in cleaning / disinfection applications can be used for internal cleaning of the intravascular port, can be reversibly attached to the port for cleaning. The chamber volume can be for example up to 3.5 mi; a preferred volume range may be from about 1 to about 3 ml, although alternative chamber sizes are contemplated for smaller or larger volumes. The chamber may have appropriate calibration marks relative to the total chamber volume. For example, a 3.5 ml fluid volume chamber may have volume marks every 1 ml, every 0.5 ml, every 0.1 ml, etc. In particular embodiments, the connector portion may have a LEUR-LOK® adapter (Becton, Dickinson and Company Corp., Franklin Lakes NJ) (not shown) for connection to a LEUR-LOK® type port. A cleaning agent can be provided within chamber 23 and can be an antibiotic or an appropriate alternative disinfectant. An exemplary agent may be an alcohol or an alcoholic solution such as that described above in relation to container 21 of the second component. In chamber applications 22 it may contain alternative or chemical agents including ethylenediaminetetraacetic acid (EDTA) and / or sodium citrate.

Once connected to the conduit port, pressure can be applied to the collapsible housing 22 for example

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cleaning, additionally

<td>squeezing,</td><td>drilling or</td><td>pushing towards</td><td>indoors</td><td>in</td><td>the</td>

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reception. External pressure or force can be used to disperse or discharge the contents of chamber 23 through connector 24 and into the connected port. Depending on the volume of chamber 23, the injected cleaning solution can be spread into the intravascular duct itself. After dispersing the contents of chamber 23, component 12 of the device can be removed from the port to allow administration of fluids that are delivered intravascularly (for example). If such delivery is not to be performed immediately on cleaning, component 12 of the cleaning device may be retained in the port until such time as intravascular delivery is desired.

In another aspect, the device described above and a methodology for administering an anti-clot agent can be used to minimize or prevent the formation of

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associated clot intravascularly or to dissolve an existing clot. In this regard, instead of or in addition to the antimicrobial agent, chamber 23 may contain an appropriate anticoagulant agent or a clot-dissolving agent. Exemplary anti-clot agents which can be used include, but are not limited to anticoagulants such as EDTA, sodium citrate, heparin, and heparin derivatives, and anti-thrombolytic agents such as a tissue plasminogen activator. In the case where lipid accumulation is a problem, an appropriate dispersion or lipolytic agent can be administered, either independently or in combination with an antimicrobial agent and / or an anti-clot agent. Injection of any agents can be accomplished in a manner analogous to that described above in relation to the cleaning agent. These applications can be accomplished using the modalities illustrated and described below.

An alternative embodiment of a device according to the invention is illustrated and described with reference to Figures 6-11. Referring to Figure 6, which illustrates an alternative example, the port access device 40 having a first syringe-like component 42 and a second component 44. Referring to Figure 7, the first syringe-like component 42 includes a plunger 46. An exploded view of the port access device is

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depicted in Figure 8. The first component 42 includes a syringe barrel-like housing 48 having a first end 5 0 and a second end 52 with an internal chamber 54. Chamber 54 may preferably have a fluid volume of from 1 to about 3.5 ml. Housing 48 may have appropriate calibration marks as discussed above with respect to the previous embodiment.

Plunger 46 may include a stem portion 56 having a seal 57. Plunger 46 may be insertable within second end 52 of housing 48. A second seal 59 may be associated with the larger diameter body of the plunger. Seal 59 is preferably presented to form a seal between the plunger and an internal surface of the device chamber. Seal 59 may preferably be an elastomeric seal which is over-molded on top of the piston (which may preferably be a molded hard plastic material). However, the invention contemplates an alternative seal material and the use of non-overmolding techniques.

The seal 57 may be a single seal or a set of seals and may be for example a set of two annular seals, a single wide, over-molded elastomeric annular seal or a sleeve or a hard plastic seal integrally molded with the stem of the piston. The presence of seal 57 can advantageously inhibit or avoid

<img file="MX355490B_D0018.tif" />

<img file="MX355490B_D0019.tif" />

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unwanted or unintentional reflux of fluid into the device chamber, thereby reducing the risk of contamination of the device and / or its contents. Alternatively, relative to the described configuration, a single seal may be over-molded to have a base portion which forms the seal between an internal chamber wall of the device and the large diameter portion of the piston and a sleeve portion which covers the walls of the smaller diameter portion of the piston (not shown).

The second component 44 is a removable lid portion having a housing 60 and an internal container 62. Container 62 may contain an applicator material 64. The applicator material may be, for example, any of those materials discussed above with respect to the previous embodiment. The second component 44 may additionally contain a cleaning agent such as those cleaning agents discussed above. The second component 44 may preferably be configured to fit over or on top of an intravascular port so that the cleaning agent can be applied to the external surfaces of the port. Such cleaning may preferably be conducted prior to administering the contents of chamber 54 (eg, an anti-clot, antimicrobial or other cleaning agent) within the

<img file="MX355490B_D0020.tif" />

port. However, the invention eUIlLé'llipTd Tá 'cleaning after port administration using the removable lid portion.

Referring next to Figure 9, which shows a cross-sectional view of device 40 shown in an intact configuration. For use, the second component 44 can be removed and used to clean the outer surface of the port. Subsequently, the first end 50 of the second component can be attached to the port, and the contents of chamber 54 can be delivered to the port by force applied to plunger 46. Alternatively, chamber 54 may be provided empty or may be provided to contain, for example, an anticoagulant agent and device 40 may be provided with a plunger 46 in a forward position. Thus device 40 can be used for applications such as obtaining and / or analyzing a blood sample from an individual by attaching the first end 50 of the device to the port and relocating plunger 46 to draw fluid through the port into the camera 54.

Referring to Figure 10, packaging 70 for supply, storage, and / or disposal of the component for access device 40 is illustrated. Such packaging includes a cover 72 and a portion 74 of

<img file="MX355490B_D0021.tif" />

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INDUSTRIAL tray. Tray portion 74 has a cavity 76 with molded retention devices 78 for device placement / retention and to help maintain device integrity and proper piston placement relative to the device chamber. Such packaging can be sealed and can be used to provide a sterile environment for device 40. As shown in Figure 11, a series 71 of individually packed unit 70 can be provided with individually sealed units to allow individual removal of units while maintaining the sterility of additional units in the series.

Another alternative embodiment is described with reference to Figures 12-13. In this embodiment, the first component 42a is the same as the immediately preceding embodiment. However, referring to Figure 12, the second component 44a comprises a double cap system. Lid housing 60a includes a container portion 62 and a second lid extension 65 which houses a second container 66. Container 62 may contain an applicator material 64 such as sponge-like materials described above. Similarly, container 66 may also contain a sponge or other applicator material 67. Container 62 may further contain a cleaning agent such as those described above.

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<img file="MX355490B_D0022.tif" />

Container 66 may preferably contain one or more microbicidal agents that differ in composition from the cleaning solution contained in lid 62 for cleaning. An exemplary agent composition within the cap portion 65 can include from about 3% to about 11% H₂OR₂. Additional components of the agent may include for example, ethanol (from about 30% to about 40%) from sodium citrate (from about 1% to about 4%) from EDTA, and / or peracetic acid (less than, or equal to about 11%). Preferably the pH will be between 5 and 10 and can be adjusted with NaOH or another appropriate base / acid to approximately pH 7.4 when necessary based on the physiological pH and biocidal activity. The presence of EDTA can provide sporocidal activity against, for example, bacillus spores forming Mn complexes and can further help stabilize H₂0₂. In combination with H₂OR₂ in the solution, a synergistic and / or additive effect can be achieved. The invention contemplates the use of alternative chelators and pH stabilizers in relation to those indicated.

It should be noted that in some cases, a similar solution having a lower peroxide content may be included within the first container 62 and in particular, cases may occur within the chamber of the first component.

IMPI

INSTmfTC 'MEXICANO DF LA FROFIE- BC industry »

Referring to Figure 137 ~ ”Ta which shows an intact device before use. In port cleaning applications, the second component 44a is removed from the device and the portion 60a is used to cover a port whereby the port is brought into contact with the contents of the container 62. The applicator material 64 can assist in applying the cleaning agent to the external surfaces of the port. When the contents of camera 54 are to be managed, component 44a is removed from the port and the first component is attached to the port. Plunger 46 is depressed so that the contents of chamber 54 are injected into the port. The syringe component is then removed from the port. A removable seal 68 can then be removed from the second cap portion 65. The lid portion 65 can be placed on the port so that the contents of the container 66 bring the port into contact. The second component 44 can then be removed from the port or can be held at the port until further port access or tampering is desired.

Referring to Figure 14, which shows an alternative embodiment where port access device 40b comprises a first component 42b, a second component 44b, and a third component 45b where the second component 44b and a third component 45b are caps. independently removable. As illustrated, the caps are

<img file="MX355490B_D0023.tif" />

they initially have opposite ends of the device and are of different sizes. However, alternative relative size and placement of caps on the device are contemplated. For example, the first component 44b and the second component 45b can be placed at the top or bottom of the wing extensions 51, 53 of the camera housing 48b.

For the illustrated exemplary configuration, the larger cap (first component 44b) can be removed from the device and can be used for cleaning the external port in a manner analogous to that described above. The second smaller cap (third component 45b) can be removed from the device after administration of the camera contents and can subsequently be used as a port cap to protect the port until subsequent port access is desired as described above . The third component 45b optionally may contain an applicator material 82 and / or a cleaning agent or a microbicidal agent as described above.

Alternative dual-cap configurations include a device that has a larger outer cap than a smaller inner cap, the first cap being removable from the second cap where one of the first and second caps is configured for use as a port cap .

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IMPI institi rre mui cano Di LA Ntuhf.DAD industrial

In the device shown in Figure 14, the cover housing 6 0b of the second component 44b and the cover housing 80 of the third component 45b can be of different colors. As such, the caps can be color-coded (or otherwise coded) to notify the user or other personnel of the status of the port or intravascular line. For example, a first color such as green may be used on all or a portion of the cap housing 8 0 which will be retained in the port after using the port to represent an appropriately sterilized port. The cap housing 60b may be a second color (eg, yellow or red) to represent cleaning or another procedure that has not yet been completed. Accordingly, the caps can be used as an added measure of safety to help ensure proper use and to help maintain sterility and maintain safety records. For example, the caps can allow visual monitoring and can be tracked by the hospital pharmacy and / or central audit software.

In addition to visual auditing in compliance with proper cleaning and sterility maintenance, a barcode, Radio Frequency Identification (RFID) and / or other pharmacy service or inventory control system associated with the device may be used to

IMPI

INSTITUTO MiJUCANo

INSTITUTO MLXlCAN 'DE 1A rtíiriSOAD INÜUSTtlA by providing an independent audit / compliance system.

Referring next to Figure 15, which describes a further alternative embodiment which can use a conventional type syringe and plunger design and can use caps according to the invention. Accordingly, the first component 42c comprises a syringe housing 48c and may have a LEURLOK® adapter at the first end 50. Plunger 46c may have a conventional type piston seal 57c configured to insert into second end 52 of housing 48c and form a seal with chamber walls 54c. The second component 44c may comprise a housing 60c which may, for example, have an internal receiving port which adjusts either internally relative to the LEUR-LOK® adapter or which fits over and covers the LEUR-LOK adapter ® at the first end 50 of the first component housing 48c. The third component 45c may also have a housing 80c configured to comprise an internal receiving port which adjusts either internally relative to a LEUR-LOK® adapter or which fits over and covers the LEUR-LOK® adapter. (or which may have an alternate type adapter) based on the type of port being cleaned.

A cross-sectional view of the device

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shown in Figure 15 is illustrated in Figure 16. Shows the exemplary type of cap housings to cover LEUR-LOK® type adapters. For example, the third component 45c has a housing 80c comprising a portion of such a housing which fits internally within a LEUR-LOK® type adapter thereby sealing such an adapter. In contrast, the second component 44c has a housing 60c which is threaded to screw onto the LEUR-LOK® type adapter. It should be understood that the description is for illustrative purposes only and that either or both caps may have the threaded or snap-lock configuration. The cap housing 60c and 80c may further be color-coded as described above.

The invention also contemplates the double cap system provided at the distal end (without administration) of the port cleaning device (not shown). In this double cap system, a first green cap can be reversibly attached both to the device and vice versa in a stacking relationship relative to a second yellow cap. Each of the two caps may be, for example, a LEUR-LOK® type adapter cap, a friction fit cap, etc. The green cap may contain the microbicidal composition described above. The yellow cap may contain for example the cleaning compositions discussed

IMPI

INSTITUTO MWICANO Dt LA PUOfltDAD

INDUSTRIAL

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above or the microbicidal composition such as that contained in the green cap since in this configuration the yellow cap is not in contact with the delivery end of the device.

Possible cap materials include, but are not limited to polyethylene, polypropylene, and / or copolymeric materials. Furthermore, the lids may preferably comprise a material or agent that has UV protection to preserve the integrity of the acid peroxide during storage, shipping, etc. The package may also contain UV protection materials to inhibit peroxide dissolution.

As mentioned above, the devices of the invention can be used to withdraw blood from an individual through an intravascular catheter or intravascular port. In particular applications, the device can be used directly for blood testing purposes. The device chamber may preferably have a chamber size in the range of 1 to 3 ml, with appropriate calibration marks as discussed above. In the case where whole blood is desired, depending on the particular purpose for the extraction, the blood may be drawn either within a device having an empty chamber or within a device containing an anticoagulant such as EDTA, sodium citrate or a

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alternative coagulant (as discussed — above). The device containing blood and an anticoagulant can then be used directly on the blood test kit or the blood can be transferred to an alternative device for testing.

In applications where serum is desired, whole blood can be withdrawn within the chamber of the device and, after coagulation, the device containing the blood sample can be centrifuged to separate the serum from the red blood cells. If the anticoagulant is presented in the device chamber, additional separation may occur to isolate the plasma. Alternatively, a filter such as a MILLIPORE® filter (Millipore Corp., Bedford MA) can be fitted onto the device after a sample is integrated into the device chamber. Such a technique can filter out red blood cells, white blood cells, and platelets allowing serum to flow from the chamber while retaining the blood cells inside the filter. Anticoagulants may optionally be provided within the chamber to allow the transfer of blood cells or plasma if desired based on the assay or other procedure being performed (i.e., complete blood count, CBC, platelet count, reticulocyte count, assays for T and B lymphocytes and chemicals.

An appropriate filter can also be used to filter out particulate samples during extraction of a

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blood sample from an individual within the chamber.

It should be understood that any of the above devices can be used for cleaning purposes, for administration purposes, or for extraction / analysis purposes. The methodology will be analogous with variation based on the particular device used as described above.

Exemplary packaging of the device is illustrated in Figures 17-19. The packaging 100 may include a cover portion 102 and a packaging tray 104 as shown in Figure 17. Referring to Figures 18 and 19, the packaging tray 104 may be a molded tray having integrally molded holding characteristics. which conform to the shape of a device 40c according to the invention. Preferably the molded features conform to the device in the undeployed position for shipping, storage, etc. Accordingly, tray 104 may have one or more features 106, 107, 108, and 109 integrally molded retainers. Tray 104 may also comprise an integrally molded receiving pedestal 110 which can be configured to receive device 4 0c in a vertical position as described in Figure 18. Such a receiving pedestal can allow device 40c to be inserted and retained during procedures.

IMPIDO

MEXICAN INSTITUTE ·

DF LA PKÍWIKDAO administrative or after use. Tray 104 can also be used for device disposal purposes.

The caps of the device according to the invention can be used independently of the devices for cleaning and protecting catheters and alternative access ports such as intravascular, peritoneal dialysis, urinary catheters and ports, etc. Accordingly, the lids can be packed independently in pairs (one for every two different sizes, colors, etc., in groups or by volume of one or more colors). Figures 20-21 show an exemplary two-lid packing system 115 having a first lid 117 which may be for example a yellow lid and which may preferably be a LEUR-LOK® type lid and a second lid 118 which can for example be a green cap and which can also be a LEUR-LOK®. The packaging system 115 may comprise a packaging tray 120 and as illustrated in Figure 21 may include integrally molded appropriate receiving ports / receiving rings 122, 124. In the case where few or additional caps are to be packed together, the tray 120 may have an appropriate number of receiving ports to reversibly receive and retain the caps. In the case where the caps differ in size (diametral), the ports may also be of different sizes when appropriate. It should be understood that

IMPI 'NSTWTC MWJCANO DE LA MWfTEÜAÍ; INDUSNUAL

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caps can be provided in groups such as one green and four yellow caps per package or any other appropriate number depending on the particular procedure for which it will be used with the number and size of packing ports corresponding to the number and size of various caps.

Referring next to Figure 22, an alternative packaging system 13 0 is illustrated. The packaging system 13 0 comprises a cover 132 and a tray 130 which has integral receiving ports 136 and 138 for receiving the covers 117 and 118. As discussed above, alternative numbers and sizes of receiving ports can be provided based on the number and sizes of caps used.

In the case where bulk lids are provided, they can be individually packed and can be individually provided in sheets or strips. The caps may alternatively be provided with catheter or conduit / port devices. They can be included in common packaging either loose or attached to a catheter or port conduit to be used for cleaning and / or protection of the port after opening the package and / or while the device is in use. In some cases, the cap (s) may be packaged in one or more sub-packages included within a larger package including a catheter device.

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