ZA200609651B - T-port with swabbable valve - Google Patents

Description

T-PORT WITH SWABBABLE VALVE

Cross-References to Related Applications "I his application claims the benefit of pro-visional application number 60/573,671, filed May 21, 2004, the disclosure of which_ is incorporated by reference herein.

BACKGROUND OF THE INVENTION

. Field of the Inveention “Whis invention relates to valves. More particularly, this invention relates to swabboable valves used in the medical industry».

Description of the Background Art

As the term implies, the term "swabbable" is often used in conjunctiorm with medical valves having a female luer fitting configusred in such a way that allows swabbing of thes exposed portion of the valve just prior fo connection with a male luemr needleless syrirage or other device.

BRepresentative swabbable valves are disclosed in U.S. Patent Number=s 6,036,171, 6,692,478, 6,221,065, 6,168,137, 6,117,114, 6,651,956, 6,113,068 and

RE37,357, the disclosures of which are hereby incorporated by reference herein. -As taught by the above-referenced patents, swabbable valves are ofterm employed in IV” sets for needleless interconnection of amn IV bag and its associated tubing to delivesr medicine to a patient intravenously. S-uch needleless interconnectio-n occurs with each device being connected end to end. =Swabbable valves preferably satisfy mai-n requirements. For example_, they should safsely withstand, without loss of performance, at least 100 connects and disconnects to an injection site before thes set is replaced. In addition, a connection is maintained for ah extended period of timme before disconnection is made. The site should still be capable of accepting subseequent connections without allowing any leakage. Valves should seal against pressurized fluid within a set. They should ’ withstand pressures in excess of, for exa-mple, 30 PSI for a short time, such as during an injection made through an adjacent si_ te or if a pump is connected in the circuit.

Further, valves should be capable of beimng manufactured at high speeds and low costs.

At the same time, the design must allow for minimal manufacturing defects. Still further, it is desirable that such valves have as few components as possible, and be easily assembled, without requiring any difficult component orientation or . positioning.

With particular regard to medical applications, valves should not contain any dead space where fluid can collect and not be readily flushed away. Also, priming volume should be minimized. Furthermore, valves should also be easily accessible by standard luer connectors aand provide secure locking features, so they could be left connected to the site withomut further assistance from a practitioner.

Another highly-desirable feature is easy and safe swabbability of the valve inlet area. Unfortunately, most cLarrent swabbable valves restrict free flow of passing fluid by employing narrow passsages, ribs or internal cannula-like features.

Restricting the flow path in such a manner may create conditions for hemolytic damage. Such restrictions also make thae valve generally more difficult to flush.

Indeed, in valves used for blood sampling, there is a need for valves i that do not have any space where fluid acould collect and stagnate. The valve should be fully flushable to preclude throsmbosis that might otherwise occur in dead spaces even of minimal sizes.

Furthermore, in meedical applications, it is usually desimrable to prevent the patient from being exposed to= the fluid which is being injected to or extracted from the patient, and it is desirabBe to insulate nurses and doctors frormn exposure to the liquid which may contain the patient's blood or waste products. However, often the instrument used to inject or withcIraw the fluid (which is generally the= male component of the syringe), retainus some of the fluid on the tip thereof, thus providing a risk to nurses and doctors of be ing exposed to the fluid. Wiping of¥F this fluid prior to disconnecting the instrument i=s highly desirable.

As taught for exarnple in U.S. Patents 6,221,065 and 65,117,114, the disclosures of which are incorpomrated by reference herein, Y-site conanectors are commonly used in IV-sets. U.S. Patent RE37,357 describes a valve in the form of a

T-port where resulting flow from the swabbable end is very limited. Such resistance to the flow creates an undesirablee condition for leaks around the access instrument's tip. A swabbable valve used as an injection port or a sampling port sshould pose minimum resistance to the flow —from the syringe or communicating Wine. Restrictive valve geometry means slow fluic] delivery and if there is blood in the= fluid, there is the possibility of hemolytic damage caused by high flow speeds at narrow or curved passages.

There presently e=xists a need for a swabbable valve p: roviding in-line access to IV tubing that is partic-ularly suited for use as a sampling amnd injection site, such as on hemodialysis sets, wi th minimal obstructions to the bloodB flow and no dead space or hard-to-flusia-out space.

Therefore, i t is an object of this invention to provide an inmprovement which overcomes the aforesmentioned inadequacies of the prior art device=s and provides an improvement which is a significant contribution to the advana.cement of the swabbable valve art.

Another object of this invention is to provide a swabbable= valve allowing needleless in-line= access to IV tubing.

Another object of this invention is to provide a swabbable= valve incorporated into a T-port facilitating needleless in-line access to medicaal tubing.

The foregoing has outlined some of the pertinent objects cf the invention. These objects should be construed to be merely illustrative off some of the more prominent features a.nd applications of the intended invention. Many other beneficial results can be agtained by applying the disclosed invention in =a different manner or modifying the invention within the scope of the disclosure. Aa.ccordingly, other objects and a fuller Landerstanding of the invention may be had by mreferring to the summary of the inventzion and the detailed description of the preferre=d embodiment in addition to the scope of the invention defined by the claimms taken in conjunction with the accommpanying drawings.

SUMMARY OF THE INVEN. TION

In preferred aspects, this invention comprises a T-port that has incorporated therein a swabbable valve allowing needlele=ss in-line access to medical tubing or other devices connected thereto. The T-port is particularly suitable for use as a samp ling and injection site. Preferably, the T-port is non—hemolytic, presents minimal obstryactions to the blood flow, requires minimal priming volume and is non- thrombogenic.

More particularly, the T-port of the invention comprises a T-port body havimg a longitudinal tubular portion with opposing ends each adapted to sealingly receiwe the end of medical tubing and a transverse valve portion having a swabbable valves incorporated therein. The T-port preferably incorporates a valve that seals itself to restrict fluid flow therein and decreases the risk of contaminants such as bacteria collecting on or within the valve into the T-port geometry. The T-port is configured such that all external surfaces in the proximity of the valve steem are accessible to be wiped clean. with a sterile swab. Further, the T-port includes a sstem that provides a relatively flat and wrinkle-free top surface which can be easily swambbed. The T-port minimally restri cts fluid flow therethrough without requiring fluid to pass narrow cannula-like passages and also without any rib-like housing features, sto thereby provide a valve strucwure with an unobstructed flow path allowing for smooth fluid flow without hemolytic damage without presenting any difficulty for rmolding and high speed assermbly. The valve structure includes a female valve caomponent that seals with a male component or instrument when the instrument is engaged therewith so that there isno leakage of fluid. ~The valve structure may include a female valve that obtains an effective seal and does not have a tendency to leak fluid into the surrounding areaa upon the male component or instrument being disengaged therefrom. Finally, the value structure allows fluid flow in both. directions upon a male component or instrument beimg engaged therewith.

During use, the T-port may be positioned in-line with a Jength of medical tubing by fitting the respective ends of the tubing into the opposing ens of the tubular portion.

The foregoing has outlined rather broadly the more pertmnent and important feature s of the present invention in order that the detailed description of the invention that fol lows may be better understood so that the present con_tribution to the art can be more fully appreciated. Additional features of the invention willl be described hereinafter whichm form the subject of the claims of the invention. It sheould be appreciated by those skilled in the art that the conception and the speci—fic embodiment disclosed may be= readily utilized as a basis for modifying or designing other structures for carrying out t_he same purposes of the present invention. It should also be realized by those skilled in tlhe art that such equivalent constructions do not depart from the spirit and scope of the inve ntion as set forth in the appended claims.

BRIEF DESCRIPTION OE THE DRAWINGS

For a fuller understanding of the mnature and objects of the inventior, reference should be had to the following detailec description taken in connection vith the accompanying drawings in which:

Fig. 1 is an end view of the slit-tywpe T-port site of the invention;

Fig. 2 is a cross-sectional view off Fig. 1, along lines A-A;

Fig. 3 is a cross-sectional view off Fig. 1 along lines A-A where the valve is accessed by a Juer;

Fig. 4 is a cross-sectional view off Fig. 1 along lines A-A with tubimmg att-ached; and

Fig. S is an isometric view of the slit-type T-port site of the invention.

Similar reference characters refer— to similar parts throughout the se—veral views of the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMEENT

As shown in Fig. 4, the T-port valve 10 of the invention is configured for connection in-line witle a length of medical tubing 12. As best shown in Fig . 2, the T-port site 10 of the invention comprises a longitudinal tubular port body 14 having opposing ends 16 and 18. A longitudinal bore 20 extends longitudinally through the pwort body 14 to fluidly interconnect the ends 16 and 18. The ends 16 and 18 are configured, preferably circular-cylindrically, to sealingly receive the ends of the tubing 12. The lomgitudinal bore 20 may include a reduced diameter portion 22 in the middle portion of ~the port body 14 to serve as a stop for the ends of the tubing 12 and to provide an increasead wall thickness at such middle portion to which is integrally formed a transverse v-alve portion 24. A bore 26 extends through the valve portion 24 to be in fluid communic ation with the bore 20 of the tubullar port body 14.

A valve stem 28 is positioned concentrically within the valve portion 24 and retained into positieon by means of a step 30 formed inwardly from the vaalve portion 24. A valve cap 32 hawing a female luer lock fitting feature 34 formed on the upper end thereof is sonically wel ded or adhesive bonded to the valve portion 24 to entrain the valve stem 24 into sealing position.

The valwe stem 28 includes a generally dome-shaped configuration adapted to sealingly engzage against the lumen of the upper portion of the val-ve cap 32.

This sealing engagement and the other functional aspects of the valve stem 2 8 are more particularly described ira the prior patent, U.S. Patent No. 6,651,956, the disc osure of which is hereby incorporated by reference herein. As disclosed therein and bezst shown in

Fig. 3, upon insertion of the male luer 40 of a needleless medical syringe or other device, the valve stem 28 is compressed inwardly whereupon the dome-shaped end th_ereof is separated from the lumen of the cap 32. As the tip 42 of the instrument luer 4-0 is pushed in the stem 28, the slit 27 eventually deforms or opens to allow entry of the tip 42 of the instrument 40, as shown in Fig. 3, and due to the resiliency of stem 28, a tight hermetic seal is formed between the stema 28 and the tip 42 of the instrument luer 40. Valve stem 28 top end 29 collapses and folds inward into the cavity 23, approximately around a fulcrum point 25 located at the area of minimal wall thickness. The slit 27 ful ly opens and fluid flow is allowed througgh the stem 28, to or from the instrument 40. T he direct non-hemolytic flow pathway is thus formed between the instrument 40 and thee main T- port site flow channel 20.

Simultaneously, the needleless medical syringe or other device luer 40 is securely fitted via female 34 to the T-port site 10. Upon disengagement of the= luer fitting to remove the medical syringe oor other device, the valve stem 28, by virtue of its inherent memory, returns to its sealing erigagement with its upper dome portion in sealing engagement with the lumen of the cap 32. Additionally, the stem 28 wipes thes tip 42 of the luer 40 clean upon its removal.

When there is no instrument engaged with the valve (as shown in Figs. 1, 2,4 and 5), the slit 27 in the end. 29 of the valve stem 28 is fully closed, and top end 29 of the valve stem 28 is generally flush with, or projects axially slightly past, the beottom of the concave area 35 of the valve body 32, allowing she top end 29 of the stem 2& and adjacent areas to be cleaned. This feature is importzant in medical applications where bacteria growth is to be avoided. To this end, a sterilizing swab can be used to clean the top end 29 of the stem 28 and adjacent areas. Concave area 35 helps to guide arm instrument luer 40 into the valve.

Finally, as best shown in Figs.1 and . 5, the tubular port body 14 nmnay include a pair of downwardly depending leg flangess 38 and a pair of upwardly extending arm flanges 36 which ergonomically facilitate the haolding of the T-port valve bxy a technician's hand while tactically facilitating the luear-fitting connection of the medical syringe or other device with the technician's other lnand.

The present disclosure includes that contained in the appended claims, as well as that of the foregoing description. Although this invention has been described in its preferred form with a certain degree of particula_rity, it is understood that the- present disclosure of the preferred form has been made onl-y by way of example and that numerous changes in the details of construction ancl the combination and arrangzement of parts may be resorted to without departing from the spirit and scope of the invention.

Now that the invention has been deszcribed,

WHAT IS CLAIMED IS:

Claims (25)

1. A T-port valve, comprising in combination: a longitudinal tubular body having opposing ends and a longitudin=al bore exc tending longitudinally therethrough to fluidly imterconnect said ends; a valve body including a bore extending therethrough in fluid cosmmunication with said longitudinal bore of said tubular body; a valve element positioned concentrically within said valve body; ; a valve cap connected to said valves body to entrain said valve element into se-aling position; and said valve element comprising a generally dome-shaped end adapteed to se alingly engage against a lumen of an upper portion of said valve cap, said valves ele=ment being compressible inwardly to separate said dome-shaped end from saidll lumen of” said cap to thereby open said T-port valve.

2. The T-port valve as set forth in Claim 1, wherein said valves body inecludes a luer fitting allowing a needleless medic al syringe or other device to be luer- fitted to said T-port valve to compress said valve element and thereby open said T "-port va_lve and allowing disengagement of the luer fitting to remove the medical syringse or other device whereupon said valve element returns to sealing engagement with sa—id upper dosme portion in sealing engagement with said lumen of said cap.

3. The T-port valve as set forth in Claim 1, wherein said valves cap is somically welded to said valve body to entrain saidl valve element into sealing position.

4, The T-port valve as set forth in Claim 1, wherein said valves cap is adhesive bonded to said valve body to entrain said valve element into sealing posii tion.

5. The T-port valv e as set forth in Claim 1, further including am step formed inwardly from said valve body=.

6. The T-port valv-e as set forth in Claim 1, wherein said longi tudinal bore includes a reduced diameter porti.on in said tubular body to serve as a stop fomran end of tubing and to provide an increased wwall thickness at a middle portion thereof tc which is integrally formed said valve body.

7. The T-port valv-e as set forth in Claim 2, wherein said tubu_lar body includes at least one downwardly depe=nding leg flanges and at least one upwardl sy extending arm flanges which ergonomically facilitates holding of the T-port valve=by a technician's hand while tactically facil itating the comnection of the medical syring=e or other device with the technician's othe=r hand.

8. A slit-type T-port s-ite incorporating a port for in-line connecticon with medical tubing and a slit-type swabbalble valve comprising a swabbable valve body positioned perpendicular to the main poort body and a resilient, deformable valve stem which is located in said valve body an_d wherein the valve body and valve stem ar—e uniformly round and have a uniformly round cross-sectional profile, said valve st :em having a linear slit at one end and having an opening at the other end, wherein the valve stem is configured to provide direct connection by the straight cylindrical flow clraannel to the port main flow channel, wherein thhe second end of said valve stem is engaged inside said valve body such that said the second end does not shift during actuation of tine valve,

, PCT/US20055/016621 wher=in the slit end is readily accessible for clean ing, wherein said slit is normally closed.

9. A slit-type T-port site as recited in Claim 8, where the vamlve is configured to be actuated via engagement with a rmale component or instrument, wherein when. the valve is actuated, the valve stem shifts imn the valve body, and the slit eof the valves stem seals against an outer surface of the male component or instrument, thus allow=ing liquid to flow directly through the valve stem.

10. A slit-type T-port site as recited in Claim 8, wherein the valve is coafi gured such that when the valvz is actuated, fdvid could flow in either direc=tion throu gh the valve.

Il. Aslit-type T-port site as recited in Claim 8, wherein the valve is confi gured such that when the valve is not actuate=d, the slit in the valve stem is. closed, there®y preventing finid from leaking into or out of an end of the valve stem.

12. A slit-type T-port site as rescited in Claim 8, wherein the valve is confi gured to be actuated via engagement with a rnale component or instrumen_t, and wher.ein the valve stem is configured to swab or c lean a tip of the male comporment or instrament upon the tip being removed from the s lit.

13. Aslit-type T-port site as re cited in Claim 8, wherein the valve inclu des a fluid flow area and neither the valve body nor the valve stem include=s any ribs which are disposed in the fluid flow area.

14. A slit-type swabbable site as recited in Claim 8, wherein: the end of -13- AMENDED SHEET

' PCT/US2005/CJ)16621 the stem is flat and wrinkie-fr-ee.

15. A slit-tzype T-port site as recited in Claim 8, wherein said —valve body has an end which provicies an opening in which sits the valve stem, said en_d of said valve body providing a conca.ve area which leads into the valves.

16. A slit-type T-port site incorporating a port for in-line conection with medical tubing and a slitt-type swababble valve comprising a swabbable val ve body positioned perpendicular to rain port body and a resilient deformable valve stermn which is located in said valve body z=nd wherein the valve body and valve stem are uniformly round and have a uniformly reound cross-sectional profile, said valve stem havingz a linear slit at one end and having an «opening at the other end, wherein said valve stem i=s configured to provide direct connection by the straight cylindrical flow channel —to the port main flow channel, wherein the second end of said valve stem is engaged iraside said. valve body such that said seczond end does not shift during actuation of the valves, wherein slit end is readily accessible £or cleaning, wherein said slit is normally closed, wherein the valve stem is configured €o collapse and fold inward generally about a fulcrumm point which is located at an area of” minimal wall thickness.

17. A slit-&ype T-port site as recited in Claim 16, where the vaalve is configured to be actuated via engagement with a male component or instrument, wherzin when the valve is actuated, thae valve stem shifts in the valve body, and the slit oe {the valve stem seals against an owster surface of the male component or instrument, thus allowing liquid to flow directly through the valve stem. -14 - AMENDED SHEET

». PCT/LS2005/€)16621

18. A slit-type T-port site as recited in claim 16, wherein the =valve is configur-ed such that when the valve is actuated, fl uid could flow in either direct ion through the valve.

19. A slit-type T-port site as recited in claim 16, wherein the valve is configured such that when the valve is not actuate=d, the slit in the valve stem is closed, thereby preventing fluid from leaking into or out of an end of the valve stem.

20. A slit-type T-port site as reecited in claim 16, wherein the valve is configuzred to be actuated via engagement with a r—nale component or instrument, and whereim the valve stem is configured to swab or ¢ leans a tip of the male compoment or instrum ent upon the tip being removed from the s lit.

21. A slit-type T-port site as recited in claim 16, wherein the valve include s a fluid flow area and neither the valve body nor the valve stem includ=s any ribs which are disposed in the fluid flow area.

22. Aslit-type swabbable site =as recited in claim 16, wherein. the end of the sterm is flat and wrinkle-free.

23. Aslit-type T-port site as reecited in Claim 16, wherein sa id valve body h as an end which provides an opening in which sits the valve stem, said end of said valve body providing a concave area which leads into the valve.

24. The T-part valve as set forth in any one of claims 1 10 7, substantially as herein described with reference to and as illustrated in any of the figures.

25. The slit type T-port site as recited in any one of claims 8 “to 23, substan tially as herein described with reference to and as illustrated in any of the Higures. -15 - AMENDED® SHEET