CA2187646A1 - Patency maintenance system - Google Patents

Patency maintenance system

Info

Publication number
CA2187646A1
CA2187646A1 CA 2187646 CA2187646A CA2187646A1 CA 2187646 A1 CA2187646 A1 CA 2187646A1 CA 2187646 CA2187646 CA 2187646 CA 2187646 A CA2187646 A CA 2187646A CA 2187646 A1 CA2187646 A1 CA 2187646A1
Authority
CA
Canada
Prior art keywords
access device
vein access
patency
solution
self
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA 2187646
Other languages
French (fr)
Inventor
Chris M. Kolber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2187646A1 publication Critical patent/CA2187646A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1404Keep vein-open rate [KVO], i.e. low flow rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)

Abstract

This apparatus is intended for maintaining the patency of an indwelling vein access device (14). The apparatus includes a vein access device (14) such as a catheter (14) connected to a self-energized container (12) having a capacity to deliver at infusate to the vein access device (14) at a flow rate of approximately 0.01-1.0 ml per hour.

Description

W095128188 21 87 646 r~ sc~
PATFl~CY ~AT~T~ CE SYST~:M
.u .,.1 nf thP InvPntinn FiPl~'7 nf ~.hF InvPntinn The invention generally relates to a method and ~1'$~
for ...-:"i.-- ..;..E the patency of an indwelling vein acces6 device and, more particularly, to such a method and ~ that utilizes a self-energized container to slowly deliver an infusate into a vein access device and which permits the adding of a n PAifnmPnt without ..".F 1 ll~, the container from the vein access device.
D~r.. u~l l of thP Prinr Art There are IlUI- e,i~7U~ ~ ,CIleS to patency m~in~n~nre currently being utilized in ~ IG practice. The most common U},~lu~Lf 3 are the heparin lock ~lu~GduuG and KVO lJlOCG~UiG.
In the KVO ~lU~GIulG a KVO solution (generally a saline solution) is slowly directed through the vein access device (IV catheter) into the patient at a ~ow ratG generally from about 1 I/liour to about 10 ml/hour. Wbile this ~lU- GIUlG seems to maintain the patency of the vGin access device, it has the, ' l vullL~_ of infusing a large volume of fluid into the patient and it limits the mobility of the patient.
~ in the widely used heparin lock ~1U~61U1GI a cûl.. ~ LIz.LGd heparin solution is contained in a capped o f segment of tubing in luid with the vein acc-Gss de~ice. The cul.. G.lL, .ILiuil of the hepa~in is generally from about 10 to about 100 int~rn~t~r~n~l heparin units per milliliter of diluent. At t$lese ~û.l~ .lLl~.Lions of heparin, it is to initiate a ~ush ~Jl UCF~l u G of the hepai-in lock device and vein access device prior to infusion of most antibiotic drugs through the vein access device, in order to avoid f ---~ on resulting from the ;,. ....I...I.;l.;lity of the drug with heparin Most heparin lock devices utilize the ~ u. bG,~ullle SASH ~U1U~ IUUG in which (a) the device is flushed with a bolus dose of saline solution, (b) the mPflif ~mPnt. or drug is infused into the device, (c) the device is again lushed with a bolus dose of saline solution, and (d) the device is illed with the cull~G~Ll~.Led . .

wo 95/28188 2 1 ~ 7 6 4 6 r~ .. /04~

solution of heparin. While tbis ~,.u~GduuG is widely regarded as effective to maintain patency of the vein access device, it is general~y regarded as being time C ~ &I, costly and iu~ the risk of sepsis.
There is a need for a method and a~ .Lu,3 for reliably &r the patency of a vein access device in a manner that - monirllls~ve steps, is ~ l ...;";...; -~: the volume of fluid that i~ infused into the patient, and does not inbibit patient mobility.
Sl-mmArv of thP Inv-ntir~n Briefly stated, the invention provides a method and a~y . ~Lus for ~ &' the patency of a vein access device into which a solution of an infusa~e is slowly delivered. 'rhe patency device is ..,hly gelf ~ .G~ and includes a means for adding a mQAirAm_n~ without ~ ....r~ the patency device from the vein access device.
In r .lancG with a preferred ....h~ l;... .l. of the invention, the patency device includes a self 0~0~ G1 container that contains infusate. The self-energized container delivers the infusate solution to the vein access device at a ~ ly constant low flow rate. The flow rate is ~ ly from about .01 to about 1.0 milliliters per hour.
The term ~self-energized c ~ Lhiu~.n, as used herein, is intended to include a wide range of known self-powered, compact pump devices that (a) include a container for storing a fluid and means for .1. ~l.~..A...~ 9uch fluid from the container at a controlled flow rate over a ' pe~iod of time, (b) do not require electricity or gravity to operate and (c) are wearable by the patient. Such devices may include, but are not limited to the following: osmotic infusion pumps;
~'- ^ .--~ ...~..~..~ or bladder infusion pumps; vapor pressure delivery pumps; hydrogel driven osmotic pumps; and the like.
y of such pump devices are those disclosed in U.S. Patent Nos.
4,692,151, 4,769,008, 4,838,862, 4,898,582, 4,410,328, 4,318,400, 4,419,096, wo 9S~28188 ~ 1 8 7 6 4 b l-~.1/L..,. ~ Y'~
3,840,009, 4,223,061 and 4,203,440.
The patency device includes an access site for directing a ~F~ ~I or drug into the vein access device. In a preferred _.. 1.~.1;.. ~l, a check valve is provided to preclude a ,.. 1: A~ I from nixing with the infusate solution in the self-energized container.
The invention, both as to its method of operation and A1~1J~ , will be best ..-,rl~ . r ~ùd from the following rlF... ;1~l - of specific ~ 0~ IY when read in rr~nnP~ti~n with the nr~ --yillg drawings.
BriFf Dr.... ~ ... of thF DrawiT~r~
FIGURE 1 is a pt-:".F~Li._ view of a preferred ~ .h~l;~
of a patency device in accul~ v~ith the invention during use;
FIGURE 2 is an enlarged elevational view of the patency device shown in FIGURE 1; and FIGI~RE3isa~-h- ~ ,u. ~IAI :,mdepictingthe - in ~ccu.d_l~e with the invention.
D~r... ;..1:.", Of t.hF PrFfFrred li....l....l;...- .,~c.
In r d_.~e with the method of the present invention, the patency of a vein access device, such as a catheter, is .-- ..~ ;,.Fd by d~ g infusate solution at a low flow rate to the vein access device. The infusate may be any solution or mixture of liquids capable of g the patency of the vei~ access device and may include, without limitAti~n sterile water, saline, aqueous solutions of alcohol or sugar, e.g. dextrose, lactose, mamutol solutions or l."~ :. "r~ or mixtures thereof where ~u~u~u~i;dLt~ Ringer's solution, lactated Ringer's solution, trace metals, salts, e.g. metal chlorides, metal cll,ulld~ or h:- I,ùlldl~s, AIII '`UA~I'1A IIr~ such as heparin, clot dis~ " e.g. TPA and ulukilla,~, drugg such ag Antihir)ti~
diùiu,~cg or any other LL_._u~ulic drug, ~ Le.~l mlt.rit;r~n~l~ such as amino acids and fat i ' - electrolytes, cardioplegia solutions, deYtran and many others. Thus, any solution which is not harmful may be used 80 lo=g as it is capable of I~ patency. The wo9~28188 2 1 8 7 646 ~ Q~ ~

delivery of such solution . ~ the patency of the vein access device in a manner that ...;..;~ the volume of fluid directed into the patient and the potential adverse effects a~ i/l.. The low ..~.i..L~lion of the ~-lico&E;ulant drug, if used, also reduces the risks r -- l 1 with the ;,~ .;lity of the drug with certain ~
The anticoagulant drug, if used, is preferably a heparin solution having a ~ from about .01 to about .99 i..~
heparin units per milliliter of diluent, although lower or higher ~v.,~.-L~lio,~ may be useful. The heparin, saline or other infusate solution is ~ ~ ly delivered to the vein access device at a flow rate from about .01 to about 1.0 millilitP~ per hour, but could be higher or lower. Most preferably, the flow rate should be at the lower end of said range.
Referring to FIG. 3, a __L_~ le~ "" of a patency device 10, in accordance with the broad concepts of the invention, is shown as including a self ~ ..~,.,;i..~i1 container 12 for directing a normal saline solution to a catheter 14 at the flow rate disclosedh~ ~u~. Anaccess site 16is ~u.~r~. Ll,y i..l~.~used between the container 12 and the catheter 14 to infuse a .. r.l;~ or drug into the catheter. A check valve 18 is ~ bly i~ u__d between the access site 16 and the container 12 to preclude the ~P-l~ or drug from mi~ing with the normal saline solution in the container.
Referring to FIGS. 1 and 2, patency device 10 includes a __lf ~..c.~i..e~ container 12 having a holding means or reservûir 20 that contains a solution --.l~;..;..~ heparin, said solution having a ---.- - -' ~ ' :---~ from about .01 to about .99 intPrnslfir~n~l heparin units per milliliter of diluent. The container 12 is designed to deliver the heparin solution from the reservoir 20 at a flow rate from about .01 to about 1.0 milliliters per hour.
The device includes an outlet line 22 for directing the heparin solution from container 12 to catheter 14 or other vein access device. Catheter 14 and outlet line 22 are provided with suitable luer or ~u,uiv~ . means 24 to facilitate C~nnpctirln Of WO95/28188 ~ /,J, 510~R7 the catheter to tbe outlet line.
In 7 d~lce with the invention, a suitable access site 16 is provided in ~....",....,;r~ n with outlet line 22 to 6_11:_ti~dly infuse a ",P~ .-1 or drug into the catheter without ~ O~ g the self-energized container from the catheter. A suitable regulating or selecting means, for e~ample a check valve, 18 is p~ -.Pd in outlet line 22 between access site 16 and the reservoir 20 to prevent the back flow of the drug into the infusate reJervoir.
As best seen in FIG. 1, the patency device 10 may be secured to tlle patient's arm or el~_~L_.c by tape or other suitable means. The device is ~,-rr; ,,lly sma7ll in size to facilitate mobility of the patient.
The device u~ f~ly includes a sufficient supply of infusate solution to last about 1 to 3 days. Should it become nc~ ~y~ the self-energized container may be replaced without removal of the catheter from the vein of the patient by l;o~ F ~ e the container at the luer c~-...o~
The specific type and cu..,,l - U..~iUII of the self-energized container 12 doe., not form a part of the invention. As aUuded to h_.~ , there are many such devices well known in the art that may ~ie utilized to deliver the infusate solution at the disclosed flow rates.
The patcncy device 10 is compact, portable and requires little ,..-~ :ori during use, which ma~es it p~Li. .ll~ly ideal for use by home care patients. The dilute nature and the low flow rate of the infusate solution avoids the necessity of saline flushes to avoid ;..1~., 1:---. v.~ith drugs and .--; .;...; =~ the quantity of fluid that is infused into the patient. The provision of the access site permits infusion of a ...~.1;. -i or drug into the patient without the device.
Although the invention has been described in terms of certain preferred ~ hc, l; ..1~ other ~ ..l.r~.l;... ~-IA that are apparent to those of ordinary skill in the art are also within the scope of the invention. A~ . ul~iu~ly~ the scope of the invention is entitled to be defined in accordance with the spirit and scope of the ~rpPnriPd claims.

Claims (8)

WHAT IS CLAIMED IS:
1. Apparatus for maintaining the patency of an indwelling vein access device, comprising:
a. a vein access device; and b. a self-energized container means for delivering infusate solution to said vein access device at a low flow rate from about .01 to about 1.0 milliliters per hour.
2. The apparatus as defined in claim 1 further including means for preventing the medicament directed into said access device from flowing into said self-energized container means.
3. Apparatus for maintaining the patency of an indwelling vein access device, comprising:
a. a vein access device; and b. means for delivering a heparin solution to said vein access device, said heparin solution having a concentration from about .01 to about .99 international heparin units per milliliter of diluent and a flow rate from about .01 to about 1.0 milliliters per hour.
4. The apparatus as defined in claim 3 wherein said means for delivering said heparin solution is a self-energized container.
5. The apparatus as defined in claim 4 including an access site for directing a medicament into said vein access device.
6. The apparatus as defined in claim 5 further including regulating or selecting means for preventing the medicament directed into said access device from flowing into said self-energized container.
7. The apparatus as defined in claim 4 wherein said vein access device is a catheter.
8. A method for maintaining the patency of an indwelling vein access device, comprising the step of delivering a dilute solution of an infusate into a vein access device at a flow rate from about .01 to about 1.0 milliliters per hour.
CA 2187646 1994-04-13 1995-04-10 Patency maintenance system Abandoned CA2187646A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US22690494A 1994-04-13 1994-04-13
US08/226,904 1994-04-13

Publications (1)

Publication Number Publication Date
CA2187646A1 true CA2187646A1 (en) 1995-10-26

Family

ID=22850920

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2187646 Abandoned CA2187646A1 (en) 1994-04-13 1995-04-10 Patency maintenance system

Country Status (4)

Country Link
EP (1) EP0755274A1 (en)
AU (1) AU2244595A (en)
CA (1) CA2187646A1 (en)
WO (1) WO1995028188A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2001276051A1 (en) * 2000-07-13 2002-01-30 Ash Medical Systems, Inc. Devices and methods for infusing a liquid into a catheter
ITBO20130338A1 (en) * 2013-06-28 2014-12-29 Raffaele Longo CATHETER

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL8301205A (en) * 1982-06-14 1984-01-02 Infusaid Corp INFUSION DEVICE.
US5205818A (en) * 1990-12-28 1993-04-27 Abbott Laboratories Patency maintenance system

Also Published As

Publication number Publication date
AU2244595A (en) 1995-11-10
WO1995028188A1 (en) 1995-10-26
EP0755274A1 (en) 1997-01-29

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