CA2058964C - Two-way valve for infusion devices - Google Patents
Two-way valve for infusion devicesInfo
- Publication number
- CA2058964C CA2058964C CA002058964A CA2058964A CA2058964C CA 2058964 C CA2058964 C CA 2058964C CA 002058964 A CA002058964 A CA 002058964A CA 2058964 A CA2058964 A CA 2058964A CA 2058964 C CA2058964 C CA 2058964C
- Authority
- CA
- Canada
- Prior art keywords
- source
- liquid
- duck
- outlet conduit
- vacuum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 238000001802 infusion Methods 0.000 title claims description 12
- 239000007788 liquid Substances 0.000 claims abstract description 69
- 239000012530 fluid Substances 0.000 claims abstract description 18
- 238000004891 communication Methods 0.000 claims abstract description 15
- 238000003780 insertion Methods 0.000 claims description 2
- 230000037431 insertion Effects 0.000 claims description 2
- 230000036316 preload Effects 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000013459 approach Methods 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 4
- 229920001971 elastomer Polymers 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- -1 polypropylene Polymers 0.000 description 3
- 241000518994 Conta Species 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229920001084 poly(chloroprene) Polymers 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 230000000135 prohibitive effect Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
Abstract
A disposable infuser is provided having a source of pressur-ized liquid contained in a liquid chamber (14). The liquid chamber (141 includes housing (20) defining an access aperture (83). A one-way duck-bill valve (80) is contained in the access aperture (83). A
separate outlet conduit (84) is provided having a blunt cannula (98).
When the outlet conduit (86) is attached to the housing (20). the blunt cannula (98) extends into the duck-bill valve (80) sufficiently to open the duck-bill valve (80) to establish fluid communication between the source of pressurized liquid (14) and the outlet conduit (84).
separate outlet conduit (84) is provided having a blunt cannula (98).
When the outlet conduit (86) is attached to the housing (20). the blunt cannula (98) extends into the duck-bill valve (80) sufficiently to open the duck-bill valve (80) to establish fluid communication between the source of pressurized liquid (14) and the outlet conduit (84).
Description
~WO91tl6101 205896g PCr/US91/01311 TWO-~AY VALVE FOR INFUSION DEVICES
FI~LD OF THE INVENTION
S ~he present ~nvention relates to the controlled delivery of liquids and, in particular, to portable apparatus for delivery of a medical liquld having a beneflcial agent to a patient.
BACr~GROUND OF ~HE INVENTION
Devices for infuslng to a patlent a beneficlal agent such as a drug diffused in a medical liquld are known in the art. The most co~mon dev~ce utilizes an elevated glass or flexible container havlng a beneficial agent dlffused ln a medlcal liquid which is fed by gravity to a patient's venous system via a lS length of flexible plastic tubing and a catheter. ~he rate of flow in this type of device is commonly regulated by an adjustable clamp on the tublng. This set-up suffers from th~
drawback of requiring a relatively stationary patient and i5 dependent on the height differential between the medical liqui~
2C~ and the patient for accurate delivery rates.
An additional type of infus~on device utilizes electro-mechanical components and a pump to provide fluid propulsion of the medical liquid for 1nfusion ~nto the patient.
Such electronically controlled ~nfuslon devices, however, suffer from several drawbacks, including the cost of such electrical components as well as the llmlt such electrical componer,ts and the necessary power source place on the size and thus portability of the device.
Another type of infusion device ut~lizes a Pressur~zed source of liquid provided by means such as an elastomeric `- 2058954 W 0 91/16101 P ~ /US91/01311 -bladder, a b~ased plunger in a syringe-type barrel or the l~ke to provide the lnfusion pressure. A typ1cal such device includes houslng conta~ning the source of pressurized llquid, an lnlet aperture to load the l~qu~d under pressure 1nto the dev~ce, and an outlet conduit to expel the liqu1d lnto the patient. The outlet condu~t typ~cally 1ncludes tubing secured to the houslng and 1n flu1d communltatlon wlth the outlet, a flow regulator to regulate the flow of l~quld, and a catheter or a connector to attach to a catheter for ~nfuslon lnto a patlent.
~h~le such devices perform ambulatory lnfuslon satisfactorily, the disposabillty of t~e devices suffers as the complexity of manufactur~ng and costs of mater~als ~ncreases.
Add~tlonally, because such lnfuslon devlces are used for d~ffer~ng infus~on rate;, d~fferent flow restrlctors are ut~llzed for dlfferent purposes. The use of dedlcated outlet condu~ts requ~re the manufacture of an entlre devlce for each - such speclfic use.
~ hat would thus be des~rable would be a disposable lnfuser device which allows flexib~llty of lnfusion rates whlle 2Q ma~ntaining a comparatively low manufacturlng and materials cost factor. The present invention achieves these requlrements.
SUMMARY OF THE INVE~IO~
The preser.t invention provides a disposable ~nfus~on device hav~ng an easy on-off d~spenslng passageway for l~quid ~nfuslon into a patient. The present device includes a source of pressur~zed l~qu~d wh~ch in a preferred embodiment ~s a cylindrical barrel. At one end of the cyl~ndr~ca~ barrel, connector housing ~s provided having a one-way dUck-bill valve which allows access to the source of pressur~zed liqu~d.
A separate, attachable dispenslng passageway ls further provided for transporting liquid fro~ the source of pressurlzed liquid to the infusion site of the patient. The dispensing passageway includes a blunt cannula which, when the dispensing passageway is secured to the housing, extends into the one-way duck-bill valve to establish fluid communication from the source of pressurized liquid to the patient.
Other aspects of this invention are as follows:
A device for infusing liquid comprising:
housing having biasing means containing a source of liquid under pressure, the housing defining an access aperture in fluid communication with the source of pressurized liquid;
a one-way valve contained in the access aperture, the one-way valve adapted to allow liquid under pressure to enter the source of pressurized liquid while retaining the pressurized liquid in the housing; and a separate outlet conduit having a cannula in fluid communication with the outlet conduit, the cannula being adapted to extend sufficiently to open the one-way valve such that upon insertion of the hollow cannula into the one-way valve, fluid communication is established between the outlet conduit and the source of pressurized liquid, said outlet conduit having a flow restrictor.
A valve for use in an ambulatory infusion device having a source of pressurized liquid and defining an access aperture to the source of pressurized liquid, the valve comprising:
an inwardly extending duck-bill valve contained in the access aperture such that liquid under pressure is allowed to enter into the source of pressurized liquid but the pressurized liquid is not allowed to escape; and a separate outlet conduit having a flow restrictor and a blunt cannula, the blunt cannula being adapted to extend into the duck-bill valve at least sufficiently to - 3a - 2058964 open the duck-bill valve to establish fluid communication with the source of pressurized liquid and the outlet conduit.
BRIEF DE8CRIPTION OF THE DRA~ING8 FIGURE 1 is a perspective view of an infusion device made in accordance with the principles of the present invention;
FIGURE 2 is a graph of the pressure exerted on the vacuum plunger of the device of FIGURE 1 as a function of the position of the vacuum plunger;
FIGURE 3 is an overhead view of the device of FIGURE 1 in the loaded position;
FIGURE 4 is an overhead view of the device of FIGURE 1 in the unloaded position;
FIGURE 5 is an overhead view of the device of FIGURE 1 in the storage position;
FIGURE 6 is a cross-sectional view of a preferred embodiment of a two-way valve made in accordance with the principles of the present invention;
FIGURE 7 is a cross-sectional view of connector housing of the device of FIGURE 6; and FIGURE 8 is a cross-sectional view of attachment housing of the device of FIGURE 6.
DET~TT~ DE8CRIPTION OF THE PREFERRED EMBODIMENT
Referring first to FIGURE 1, a perspective view is seen wherein a device made in accordance with the principles of the present invention is designated generally by the reference number 10. The device 10 includes a first tubular housing defining a rigid cylindrical barrel 12. $he rigid cylindrical W O 91~16101 2 0 5 8 9 6 g P ~ /~'S91/01311 _ barrel 12 defines a tubular liquid chamber 14 ~hich includes an lnterior 16. The rigid cylindr1cal barrel 12 ls preferably molded of a transparent mater~al such as plast~c to enable clear visual lnspectlon of the 1nter1Or 16 of the l~quid chamber 14.
Impr~nted, inscribed or otherwise appl~ed to the barrel ~all, a graduated volume scale 18 ls also preferably prov1ded.
Sæallngly attached to the anterior end of the llquld chamber 14 ls a plug houstng 20. The plug hous~ng 20 deflnes an access aperture extending therethrough ~hich establ~shes flu~d communicat~on w~th the llqu~d chamber 1nterlor 16. Also sealingly attached to the plug housing 20 1s a fluid conduit which lncludes tubing 22. The tubing 22 1ncludes a proximal end and a distal end. Secured on the d~stal end of the tub~ng 22 ~n fluld communication with the interlor of the tublng 22 ls a flow restrictor 24. In a preferred embodlment, the flow restrlctor 24 ~s a glass caplllary tube. The flow restrlctor 24 can be contained in housing wh~ch can preferably ~nclude a luer connector 25 for connection to a catheter (not shown) having a cooperative luer connector.
The tubing 22 proximal end ~s secured to the plug ~ith the interior of the tubing 22 in fluld communicat~on wlth the access aperture. While the tubing 22 can be permanently secu~ed to the plug housing 20 by adhes~ve or the like, 1n a preferred embodiment the tubing 22 can be disconnectable from the plug housing 20. A preferred embod~ment of such detachable connector w~ll be described in detail below.
A liquid plunger 26 ~s contained w~thin the l~qu~d chamber 14. The liquid plunger 26 ~ncludes a pa~r of outwardly projecting ribs 28 which are s~zed and shaped t~ establish a sliding, sealing engagement with the ~nterior surface 16 of the barrel 12. The outwardly pro~ecting r~bs 28 of the llqu~d plunger 26 are preferably formed integrally with the liqu~d 2Q58g6~
_ N0 91/16101 ~ PC~r/VS91/01311 plunger 26 and can preferably be made of a polypropylene coated rubber, sil~con rubber, coated neoprene, or a simllar type of material to provlde a seallng, slldlng engagement ~hlle minimlzing the frlctlon between the llquld plunger 26 and the lnterlor surface 16 of the barrel 12. Addlt10nally, the anterior surface 30 of the llquld plunger 26 exposed to the lnterlor 16 of the l~quld chamber 14 ls preferably formed ln a conlcal shape whlch cooperates wlth the tonlcally shaped houslng 32 at the anterlor end of the l~quld chamber 14 to form a seallng engagement when the llquld chamber 14 ls emDty. Thls lnsures that substantlally all of the llquld ~n the l~quid chamber 14 ls expressed out of the llquid chamber 14 durtng lnfuslon.
Provided extending from the posterlor s~de of the liquid plunger 26 ls a plunger arm 36. Provlded at the posterlor perlphery of the plunger arm 36 ls an enlarged dlameter protruslon which defines a plunger head 38.
Additionally provlded and secured to the tubular llquid chamber 14 by connector means 40 ls at least one addltional tubular houslng again havlng a rlgld cyllndrlcal barrel 42.
This second rig~d cylindr1cal barrel 42 deflnes a tubular vacuum chamber 44 havlng an lnterlor surface 50. Agaln, the second rlgld cyllndrlcal barrel ls preferably molded of a transparent material such as plastlc to enable clear vlsual lnspectlon of the lnterlor of the vacuum chamber 44. Hhlle ln the preferred embodiment deplcted hereln, t~o vacuum chambers 44 are provlded, the present ~nvention contemplates any number of vacuum chambers, from one to more than two, ~hich can then be utllized in combination to provlde different forces on the~llquld as explalned in detail below.
~he anterior end of the vacuum chamber 44 lncludes housing 46 which seals the vacuum chamber 44. ~his anterior houslng 4 is preferably flat to reduce the surface area exposed to the 20~8964 lnterlor of the vacuum chamber 44 to the smallest posslble amount. Addit~onally provided in the vacuum chamber 44 ls a vacuum plunger 48. The vacuum plunger 48 lncludes a palr of outwardly pro~ectlng rlbs 52 whlch are slzed and-shaped to establlsh a slldlng, seallng engagement ~lth the lnterlor surface 50 of the vacuum chamber 44. Aga~n, the outwardly pro~ectlng rlbs 52-of the vacuum plunger 48 can be preferably made of a polypropylene coated rubber, sll~con rubber, coated neoprene or a slmllar type of materlal to prov~de a sl1dlng, sealina engagement wh~le mlnlmlzing the frictlon between the plunger 48 and the lnterlor surface 50 of the vacuum chamber 44. Unll~e the liqu~d plunger 26, the vacuum plunger 48 lncludes at ~ts anterior end faclng the lnterlor of the vacuum chamber 44 a flat surface 56 to reduce the surface area of the vacuum plunger 48 exposed to the vacuum wlthln the vacuum chamber 44. Prov~ded extendlng from the posterlor slde of the vacuum plunger 4& ~s a plunger arm 58. Provlded at the poster~or perlphery of the plunger arm 58 ls a plunger head 60.
Because of the charactertstlcs of the vacuum whlch provldes the bi2s tc provide a pressurized source of ltquld, an essentially constant forte ls applled on the vacuum plunger 48 throughout the length of the vacuum chamber 44. Thls constant force results from the atmospherlc pressure whlch provldes a force on the posterlor of the vacuum plunger 48 whlch ls a constant force depending on the atmospherlc pressure to whlch the devlce ls exposed. Because a vacuum is contained on the anterior of the vacuum plunger 48, a nearly constant force of approxlmately zero ls applled to the anterlor of the vacuum plunger 48 throughout the length of the vacuum ~hamber 44. It is thus seen that throughout the length of the vacuum chamber 44 approximately constant forces are applled both anterlorly and posteriorly to the vacuum plunger 48.
_ W O 91/16101 2 058 96 4 PC~r/US91~01311 However, because nature does not know a perfect vacuum, a small amount of force is applied on the anterior end of the vacuum plunger 48. ~hroughout most of the length of the vacuum chamber 44, this small amount of force is sufficlently "dlluted"
by the larger "amount" of vacuum to result in a negligible force on the vacuum plunger 48. As the vacuum plunger 48 approaches the closed end 46 of the vacuum chamber i4, the percentage of the evacuated area ~hlch is a "perfect" vacuum decl~nes ~hile the area of the evacuated area which ~s a "force" increases.
Th'; results ~n a logar~thmic pressure spike applled to the anterior of the vacuum plunger 44 near the closed end 46 of the vacuum chamber 44 This pressure spike ~orks to offset the atmospheric pressure on the poster~or side of the vacuum plunger 48 which results 1n a drop in the bias~ng force on the vacuum plunger 48.
Referring to FIGUR~ 2, the forces applied on the anterior end of the vacuum plunger 48 are seen as a function of the distance along the vacuum chamber 44 that the vacuum plunger 48 travels It is seen that throughout most of this distance a relatively constant, extremely small force (a) ls applied whlch ~esults ln a near constant infusion of the liquid. It is further seen that near the area where the vacuum plunger 48 approaches the closed end 46 of the vacuum chamber 44, the force appl~ed on the anterior of the vacuum plunger 48 spikes upwardly (b) and approaches atmospherlc pressure.
While this phenomena has been recognized in the art, attempts to elim~nate this phenomena ha~e not been sat~sfactory which has resulted in a lack of commercial~zed ~nfusers utilizin3 a vacuum source as a biastng means. ~he attempts ~n the prior art to reckon with this phenomena are pr~marily attempts to perfect the vacuum conta~ned ~n the evacuated area in an attempt to minimize this pressure spike. While these w O 91/16101 2058964 P~/US91~01311 ~
attempts to perfect a vacuum are theoretically possible, in practice such perfection of the vacuum source quickly results in manufacturing techniques such as manufacturing ~n a vacuum ~hich are cost prohibitive to a dlsposable 1nfuser. The present device lO employs means for preloadlng the vacuum which prevents this force from resulting in 1naccurate infusion.
The vacuum plunger 48 is connected to the l~quid plunger 26 by means of a removable support 62 ~hlch extends between the vacuum plunger arm ~8 and the llquid plunger ar~ 36. Thus, bet~een the vacuum plunger 48 and the l~quld plunger 2~, a generally U-shaped arm extends to transfer the force exerted on the vacuum plunger 48 to the liquid plunger 26 to create in the liqu~d chamber 14 a source of pressurized liquid. ~hile ln the presently dep1cted embodlment, thls connectlon is generally lS U-shaped, the present ~nvent~on, of course, contemplates the use of functlonally equlvalent shaped arm and plunger orientations ~hich result ln a functlonal equivalent to the present device.
Referr~ng now to FIGURES 3, 4 and 5, overhead views of the device of FIGURE l are seen. As is seen partlcularly ln FIGURS
3 and 4, the liquid plunger 26 is offset posteriorly from the vacuum plunger 48 a dlstance (d). As ls seen partlcularly ln FIGURE 4, this offset distance (d) results 1n the liquid plunger 26 abutting against the anterior houstng 20 of the liquld chamber 14 before the vacuum plunger 48 abuts agalnst the closed end 46 of the vacuum chamber 44. This distance (d) is referred to herein as the preload distance. Referring to ~IGURE 2, this preload distance (d) is calculated to allo~ infus~on to be com~leted before the vacuum plunger 48 approaches the pressure spike applied on the anterior portion of the vacuum plunger 48.
~hus, by utllizing this preload distance (d), the rate of tnfusion is seen to be relatively constant throughout the entire infusion.
~ O 91/16101 2 0 ~ 8 9 6 ~ PC~r/US91/01311 Referring now to FIGURE ~, the application of this preload distance (d) on the device is descr~bed. The device is seen in storage in which the vacuum plunger 48 as well as the liquid plunger 26 is abutted against the anter~or of the respective chambers 14, 44. Thus, when in storage in this position, nc vacuum or bias is applied to the vacuum plunger 48 and thus the achieved purity of the vacuum is assured dur~ng storage and shipping.
Prior to use of the device 10, the removable support 62 is attached to complete the generally U-shaped arm between the vacuum plunger 48 and the liquid plunger 26. The removable support 62 includes at least one slot 66 (best seen in FIGURE
1), the specific number of which correspond to the specific number of vacuum chambers 44, and defines a posterior 67 and anterior surface 69. Prior to use, the removable support 62 is slid over the vacuum plunger arm 58. The siZe of the slot 6~ i5 sufficiently large to slide over the vacuum plunger arm 58 bu~
is smaller than the diameter of the plunger head 60. Thus, the vacuum plunger head 60 abuts against the posterior surface 67 cf 2Q the removable support 62.
~ he removable support 62 is oriented such that the plunger head 38 of the liquid plunger arm 36 abuts aga~nst the anterior surface 69 of the removable support 62. Thus, when the removable support 62 i5 attached to the device 10, the distance between the vacuum plunger arm 67 and the liquid plunger arm 36 is established as the thickness of the removable support 62.
The removable support 62 in conjunction w~th the plunger arm;
36. 58 and plunger heads 38. 60 act as means for app~ying to a unloaded device a preload to the vacuum source. I~To then load 3Q the infuser, a liquid containing a beneficial agen~ dispersed therein is added under pressure to the liquid chamber 14, the force of which draws the vacuum plunger 48 posteriorly and results in a source of pressuri~ed liquid in the liquid chamber Wo 91/16101 2 0 5 8 9 6 4 PCI/US91/0131 1 Because nature does not know a perfect vacuum, the vacuum plunger 26 will never freely abut against the closed end 46 of the vacuum chamber 44. ~he small dlstance at which the vacuum plunger 26 comes to rest from the closed end-46 of the vacuum chamber 44 is referred to as a tolerance distance (t). This tolerance distance (t) depends on the pur~ty of the vacuum achieved.
The amount of preload distance (d) needed to assure desired accuracy of infusion can be determined as a function of the tolerance dlstance (t). Initially, we know at any g~ven distance of the vacuum plunger 48 along the vacuum chamber 44, the forces exerted on the anter~or and posterior surface of the vacuum plunger 48 must be equal. S1nce f . PV, where P i5 pressure, V ls volume, and f is force, 1t ~s known:
PlVl . P2V2 (l) where Pl is the pressure exerted on the posterior surface of the vacuum plunger 48, P2 is the pressure exerted on the anter~or surface of the vacuum plunger 48. Vl ls the volume of the vacuum chamber 44 posterior to the vacuum plunger 48, and V2 is the volume of the evacuated portion of the vacuum chamber 44.
It is also known that V . (~D2/4)(h) for a cylinder where D
is the diameter and h is the height of the cylinder. Further, the height of the vacuum chamber 44 as a ~hole is x ~ t where x is the length the vacuum plunger travels. Substituting into equation (l), Pl(~D2/4)tt) . P2(~D2/4)(t~x) (2) solving for P2:
P2 - P~ D2/4)(t) 3D (~D2/4)(t~x) 21~589~4 W 0 91/16101 ~ P ~ /US91/01311 cancelling:
P2 - P1(t) (3) (t~x) Further, we can assume that Pl ~s at atmospheric pressure or 14.6960 pslg. Utillzing varlous values for x and t, we obtain the followlng values of P2 ln psig:
DISTANCE DISTANCE t ln ~nches x 1n lnches 0 001 0.002 0.005 0 ol 0.02 3.0 O.OOS 0.010 0.024 0.049 0.097 2.0 0.007 0.015 0.037 0.073 0.146 1.5 0.010 0.020 0.049 0.097 0.193 1.~ 0.015 0.029 0.073 0.146 0.288 0.5 0.029 0.059 0.146 0.288 0.565 0.2 0.073 Q.146 0.358 0.700 1.336 o.l 0.146 0.288 0.700 1.336 2.449 VERIFICATION OF PRESSURE CHANGE WITH PISTON TRAVEL
FORMULA IS P2 - Pl(t)l~t~x) ~hus, when the vacuum plunger 48 ls at various distances (x) along the length of the vacuum chamber 44, the evacuated portion exhlbits the following degree of vacuum:
W O 91/t6101 2 0 5 8 9 6 ~ PC~r/US91/013~`~
DISTANC~ DISTANCE t ln inches x in lnches 0.001 0.002 0.005 0.01 0.02 3.Q 99.97Z 99.93% 99.83X99.67~ 99.347.
2.0 99-95% 99.90% 99.75X99.50Z 99.01%
S 1.5 99.93% 99.8~X 99.67X99.34X 98.68%
1.Q 99.90% 99.B0% 99.50Z 99.01% ' 98.04%
0.5 99.80X 99.60% 99.01X98.04% 96.15%
0.2 99.50'j. 99.01Z 97.56Z95.Z~X 90.91X
0.1 9g.01~ 98.04% 95.24X90.91% 83.33%
DEGR~E OF VACUUM~
~100% represents absolute vacuum B~ utilizing these values, the deslred degree of accuracy can be achieved by knowing the tolerance of manufacture as well as the length of the vacuum chamber 44. ~or example. lf a tolerance of between .001 to .002 lnches ls achleved and an accuracy of ~.5% is desired, approxlmating from TABL~ 2, a preload distance of greater than .5 lnches is requlred.
Addition,ally, as ~s seen the force executed as the vacuum plunger 48 is dependent on the atmospheric pressure executed on the device lQ. To understand how dlfferences ln the atmospheric pressure could affect the present devlce 10, atmospheric conditions were obtained from rhe Natlonal Weather Service for the following sample cities:
~VO 91/16101 2~589 ~ ~ P~/~ISg1/013l 1 Boston Los Anaeles Chicago Denver ELEV~ 15 ft.270 ft. 658 ft. 5,283 ft.
PRESSURE~
MAY~ 1.036 1.019 1.032 .843 MIN .948 .975 .956 .792 AVG 1.001 .997 .980 .823 RANGE~
MID ~4.4% ~2.2% ~3.8% ~3.1%
ATMOSPHERIC CONDITIONS
Above sea level In Atm~s ~- In percentages It i5 thus seen that the changes ~n atmospheric pressure in a given sample city results ~n a maximum change in biasing press,ure of ~4.4Z., which is well within a satisfactory tolerance range of infusion. Additionally, dlfferences ln average atm~spheric pressure for different geograph~c areas can slmpl~
be compensated by adjusting the concentrat~on of benef~c~al 2gent in the medical liquid by a pharmac~st.
Referring nor to FIG~RES 6 through 8, the preferred embodiment of valve means 70 contained in the plug housing 20 cf the,liquid chamber 14 is seen. Referring first to FIGUR~ 7, a plug portion 68 of the valve means 70 in the loading or storagC
mod~ is seen. The valve ~ncludes a connector housing 72 which defines a connector 74. The connector can preferably be 2 female luer, The female luer includes an aperture 76 defined therein which is ln fluid communication with a duck-bill valve 80. The duck-bill valve 80 includes a pair of lip,s 82.
Contained on the downstream side of the duck-bill val~ve 80 ~s an access aperture &3 which is in liquid commun~cation with the interior of the liquid chamber 14. Thus, to load t'he liquid chamber 14, a device such as a svringe capable of providing W O 91tl6101 P ~ /VS91/01311 ~
- 14 _ liquid under pressure and having a cooperating connector such as a male luer is attached to the female luer and the llquid contained within the syringe is expressed under pressure past the duck-bill valve 80 to the interior of the l-~quid thamber 14 to define a source of pressurized liquid. Aftér loading, the duck-bill valve 80 contains the liquid under pressure withln the liquid chamber 14.
Referring now to FIGURE 8. an outlet conduit 84 of the valve means 70 is seen in detail. The tubing 22 is secured to a lG filter housing 86 eontained on the outlet conduit 84 by means such as an adhesive. The filter housing 86 defines a filter aperture which contains a filter 88 in fluid communication with the interior of the tubing 22. The filter 88 is utilized to prevent non-dissolved beneficial agent contained in the medical liquid from enterins the fluid conduit and thus the venous system of the patient. The filter 88 can be preferably made of stainless steel, platinum wire, or other suitable material or of anv of a varietv of polvmers such as polytetrafluoroethylen~
having a porou~ or multifilament configuration capable of operating as a screen and which will be substantially unreactive in the presence of the beneficial agent.
The outlet conduit 84 further includes housing 92 which defines a connector 94 which acts cooperatively with the connector 74 on the plug portion 68. In the preferred embodiment, this cooperating connector 94 is a male luer. The housing further defines an aperture 96 in fluid communication with the filter 88. Extending from the aperture,96 is a blunt cannula 98 defining an internal channel in fluid communication - with the aperture 96.
The blunt cannula 98 extends a distance from the housing 92 which is defined b~ the duck-bill valve 80. Specificall~, The blunt cannula 98 must extend sufficiently from the housing 92 t~
open the duck-bill valve 80 when the connectors 74, 94 are secured. ~hile extending the blunt cannula 98 past the duc~-b _ W O 91/16101 P ~ /US91/01311 valve 80 does satisfactorily open the duck-bill valve 80, it has been found that such extension results in an amount of leakage of the liquid stored in the liquid chamber 14 proportional to the distance past the duck-bill valve 80 that the blunt cannula 98 extends.
Thus~ in a preferred embodiment, the blunt cannula 98 extends into the duck-bill valve 80 sufficiently to separate the lips 82 of the duck-bill valve 80 without penetrating through.
In a further preferred embodiment, the outer periphery of the diluent cannula 98 is about flush with the end of the duck-bill valve 8Q. In this embodiment, small manufacturing tolerances will not appreciably affect the performance of the valve as sufficient penetration is assured to separate the lips 82 but extensive leakage is prevented.
lS After loadins, to use the device 10, the male luer is connected to the female luer. This forces the blunt cannula 9~
into engagement with the duck-bill valve 80. When the male luer and female luer are secured, the open end of the blunt cannula 98 extends into the duck-bill valve 80 to establish fluid 2~! communicatior with the interior of the liquid chamber 14 ~best seen in FiGURE 6). Thus, the liquid under pressure in the liquid chamber 14 rushes into the blunt cannula 98, past the filter 8~, into the tubing 22, and past the flow restrictor 2 contained in the tubing 22 to the patient.
It should be understood that various changes and mo~ifications to the preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminfshing its 3Q attendant advantages. It is, therefore, intended that such changes and modifications be covered by the appended claims.
FI~LD OF THE INVENTION
S ~he present ~nvention relates to the controlled delivery of liquids and, in particular, to portable apparatus for delivery of a medical liquld having a beneflcial agent to a patient.
BACr~GROUND OF ~HE INVENTION
Devices for infuslng to a patlent a beneficlal agent such as a drug diffused in a medical liquld are known in the art. The most co~mon dev~ce utilizes an elevated glass or flexible container havlng a beneficial agent dlffused ln a medlcal liquid which is fed by gravity to a patient's venous system via a lS length of flexible plastic tubing and a catheter. ~he rate of flow in this type of device is commonly regulated by an adjustable clamp on the tublng. This set-up suffers from th~
drawback of requiring a relatively stationary patient and i5 dependent on the height differential between the medical liqui~
2C~ and the patient for accurate delivery rates.
An additional type of infus~on device utilizes electro-mechanical components and a pump to provide fluid propulsion of the medical liquid for 1nfusion ~nto the patient.
Such electronically controlled ~nfuslon devices, however, suffer from several drawbacks, including the cost of such electrical components as well as the llmlt such electrical componer,ts and the necessary power source place on the size and thus portability of the device.
Another type of infusion device ut~lizes a Pressur~zed source of liquid provided by means such as an elastomeric `- 2058954 W 0 91/16101 P ~ /US91/01311 -bladder, a b~ased plunger in a syringe-type barrel or the l~ke to provide the lnfusion pressure. A typ1cal such device includes houslng conta~ning the source of pressurized llquid, an lnlet aperture to load the l~qu~d under pressure 1nto the dev~ce, and an outlet conduit to expel the liqu1d lnto the patient. The outlet condu~t typ~cally 1ncludes tubing secured to the houslng and 1n flu1d communltatlon wlth the outlet, a flow regulator to regulate the flow of l~quld, and a catheter or a connector to attach to a catheter for ~nfuslon lnto a patlent.
~h~le such devices perform ambulatory lnfuslon satisfactorily, the disposabillty of t~e devices suffers as the complexity of manufactur~ng and costs of mater~als ~ncreases.
Add~tlonally, because such lnfuslon devlces are used for d~ffer~ng infus~on rate;, d~fferent flow restrlctors are ut~llzed for dlfferent purposes. The use of dedlcated outlet condu~ts requ~re the manufacture of an entlre devlce for each - such speclfic use.
~ hat would thus be des~rable would be a disposable lnfuser device which allows flexib~llty of lnfusion rates whlle 2Q ma~ntaining a comparatively low manufacturlng and materials cost factor. The present invention achieves these requlrements.
SUMMARY OF THE INVE~IO~
The preser.t invention provides a disposable ~nfus~on device hav~ng an easy on-off d~spenslng passageway for l~quid ~nfuslon into a patient. The present device includes a source of pressur~zed l~qu~d wh~ch in a preferred embodiment ~s a cylindrical barrel. At one end of the cyl~ndr~ca~ barrel, connector housing ~s provided having a one-way dUck-bill valve which allows access to the source of pressur~zed liqu~d.
A separate, attachable dispenslng passageway ls further provided for transporting liquid fro~ the source of pressurlzed liquid to the infusion site of the patient. The dispensing passageway includes a blunt cannula which, when the dispensing passageway is secured to the housing, extends into the one-way duck-bill valve to establish fluid communication from the source of pressurized liquid to the patient.
Other aspects of this invention are as follows:
A device for infusing liquid comprising:
housing having biasing means containing a source of liquid under pressure, the housing defining an access aperture in fluid communication with the source of pressurized liquid;
a one-way valve contained in the access aperture, the one-way valve adapted to allow liquid under pressure to enter the source of pressurized liquid while retaining the pressurized liquid in the housing; and a separate outlet conduit having a cannula in fluid communication with the outlet conduit, the cannula being adapted to extend sufficiently to open the one-way valve such that upon insertion of the hollow cannula into the one-way valve, fluid communication is established between the outlet conduit and the source of pressurized liquid, said outlet conduit having a flow restrictor.
A valve for use in an ambulatory infusion device having a source of pressurized liquid and defining an access aperture to the source of pressurized liquid, the valve comprising:
an inwardly extending duck-bill valve contained in the access aperture such that liquid under pressure is allowed to enter into the source of pressurized liquid but the pressurized liquid is not allowed to escape; and a separate outlet conduit having a flow restrictor and a blunt cannula, the blunt cannula being adapted to extend into the duck-bill valve at least sufficiently to - 3a - 2058964 open the duck-bill valve to establish fluid communication with the source of pressurized liquid and the outlet conduit.
BRIEF DE8CRIPTION OF THE DRA~ING8 FIGURE 1 is a perspective view of an infusion device made in accordance with the principles of the present invention;
FIGURE 2 is a graph of the pressure exerted on the vacuum plunger of the device of FIGURE 1 as a function of the position of the vacuum plunger;
FIGURE 3 is an overhead view of the device of FIGURE 1 in the loaded position;
FIGURE 4 is an overhead view of the device of FIGURE 1 in the unloaded position;
FIGURE 5 is an overhead view of the device of FIGURE 1 in the storage position;
FIGURE 6 is a cross-sectional view of a preferred embodiment of a two-way valve made in accordance with the principles of the present invention;
FIGURE 7 is a cross-sectional view of connector housing of the device of FIGURE 6; and FIGURE 8 is a cross-sectional view of attachment housing of the device of FIGURE 6.
DET~TT~ DE8CRIPTION OF THE PREFERRED EMBODIMENT
Referring first to FIGURE 1, a perspective view is seen wherein a device made in accordance with the principles of the present invention is designated generally by the reference number 10. The device 10 includes a first tubular housing defining a rigid cylindrical barrel 12. $he rigid cylindrical W O 91~16101 2 0 5 8 9 6 g P ~ /~'S91/01311 _ barrel 12 defines a tubular liquid chamber 14 ~hich includes an lnterior 16. The rigid cylindr1cal barrel 12 ls preferably molded of a transparent mater~al such as plast~c to enable clear visual lnspectlon of the 1nter1Or 16 of the l~quid chamber 14.
Impr~nted, inscribed or otherwise appl~ed to the barrel ~all, a graduated volume scale 18 ls also preferably prov1ded.
Sæallngly attached to the anterior end of the llquld chamber 14 ls a plug houstng 20. The plug hous~ng 20 deflnes an access aperture extending therethrough ~hich establ~shes flu~d communicat~on w~th the llqu~d chamber 1nterlor 16. Also sealingly attached to the plug housing 20 1s a fluid conduit which lncludes tubing 22. The tubing 22 1ncludes a proximal end and a distal end. Secured on the d~stal end of the tub~ng 22 ~n fluld communication with the interlor of the tublng 22 ls a flow restrictor 24. In a preferred embodlment, the flow restrlctor 24 ~s a glass caplllary tube. The flow restrlctor 24 can be contained in housing wh~ch can preferably ~nclude a luer connector 25 for connection to a catheter (not shown) having a cooperative luer connector.
The tubing 22 proximal end ~s secured to the plug ~ith the interior of the tubing 22 in fluld communicat~on wlth the access aperture. While the tubing 22 can be permanently secu~ed to the plug housing 20 by adhes~ve or the like, 1n a preferred embodiment the tubing 22 can be disconnectable from the plug housing 20. A preferred embod~ment of such detachable connector w~ll be described in detail below.
A liquid plunger 26 ~s contained w~thin the l~qu~d chamber 14. The liquid plunger 26 ~ncludes a pa~r of outwardly projecting ribs 28 which are s~zed and shaped t~ establish a sliding, sealing engagement with the ~nterior surface 16 of the barrel 12. The outwardly pro~ecting r~bs 28 of the llqu~d plunger 26 are preferably formed integrally with the liqu~d 2Q58g6~
_ N0 91/16101 ~ PC~r/VS91/01311 plunger 26 and can preferably be made of a polypropylene coated rubber, sil~con rubber, coated neoprene, or a simllar type of material to provlde a seallng, slldlng engagement ~hlle minimlzing the frlctlon between the llquld plunger 26 and the lnterlor surface 16 of the barrel 12. Addlt10nally, the anterior surface 30 of the llquld plunger 26 exposed to the lnterlor 16 of the l~quld chamber 14 ls preferably formed ln a conlcal shape whlch cooperates wlth the tonlcally shaped houslng 32 at the anterlor end of the l~quld chamber 14 to form a seallng engagement when the llquld chamber 14 ls emDty. Thls lnsures that substantlally all of the llquld ~n the l~quid chamber 14 ls expressed out of the llquid chamber 14 durtng lnfuslon.
Provided extending from the posterlor s~de of the liquid plunger 26 ls a plunger arm 36. Provlded at the posterlor perlphery of the plunger arm 36 ls an enlarged dlameter protruslon which defines a plunger head 38.
Additionally provlded and secured to the tubular llquid chamber 14 by connector means 40 ls at least one addltional tubular houslng again havlng a rlgld cyllndrlcal barrel 42.
This second rig~d cylindr1cal barrel 42 deflnes a tubular vacuum chamber 44 havlng an lnterlor surface 50. Agaln, the second rlgld cyllndrlcal barrel ls preferably molded of a transparent material such as plastlc to enable clear vlsual lnspectlon of the lnterlor of the vacuum chamber 44. Hhlle ln the preferred embodiment deplcted hereln, t~o vacuum chambers 44 are provlded, the present ~nvention contemplates any number of vacuum chambers, from one to more than two, ~hich can then be utllized in combination to provlde different forces on the~llquld as explalned in detail below.
~he anterior end of the vacuum chamber 44 lncludes housing 46 which seals the vacuum chamber 44. ~his anterior houslng 4 is preferably flat to reduce the surface area exposed to the 20~8964 lnterlor of the vacuum chamber 44 to the smallest posslble amount. Addit~onally provided in the vacuum chamber 44 ls a vacuum plunger 48. The vacuum plunger 48 lncludes a palr of outwardly pro~ectlng rlbs 52 whlch are slzed and-shaped to establlsh a slldlng, seallng engagement ~lth the lnterlor surface 50 of the vacuum chamber 44. Aga~n, the outwardly pro~ectlng rlbs 52-of the vacuum plunger 48 can be preferably made of a polypropylene coated rubber, sll~con rubber, coated neoprene or a slmllar type of materlal to prov~de a sl1dlng, sealina engagement wh~le mlnlmlzing the frictlon between the plunger 48 and the lnterlor surface 50 of the vacuum chamber 44. Unll~e the liqu~d plunger 26, the vacuum plunger 48 lncludes at ~ts anterior end faclng the lnterlor of the vacuum chamber 44 a flat surface 56 to reduce the surface area of the vacuum plunger 48 exposed to the vacuum wlthln the vacuum chamber 44. Prov~ded extendlng from the posterlor slde of the vacuum plunger 4& ~s a plunger arm 58. Provlded at the poster~or perlphery of the plunger arm 58 ls a plunger head 60.
Because of the charactertstlcs of the vacuum whlch provldes the bi2s tc provide a pressurized source of ltquld, an essentially constant forte ls applled on the vacuum plunger 48 throughout the length of the vacuum chamber 44. Thls constant force results from the atmospherlc pressure whlch provldes a force on the posterlor of the vacuum plunger 48 whlch ls a constant force depending on the atmospherlc pressure to whlch the devlce ls exposed. Because a vacuum is contained on the anterior of the vacuum plunger 48, a nearly constant force of approxlmately zero ls applled to the anterlor of the vacuum plunger 48 throughout the length of the vacuum ~hamber 44. It is thus seen that throughout the length of the vacuum chamber 44 approximately constant forces are applled both anterlorly and posteriorly to the vacuum plunger 48.
_ W O 91/16101 2 058 96 4 PC~r/US91~01311 However, because nature does not know a perfect vacuum, a small amount of force is applied on the anterior end of the vacuum plunger 48. ~hroughout most of the length of the vacuum chamber 44, this small amount of force is sufficlently "dlluted"
by the larger "amount" of vacuum to result in a negligible force on the vacuum plunger 48. As the vacuum plunger 48 approaches the closed end 46 of the vacuum chamber i4, the percentage of the evacuated area ~hlch is a "perfect" vacuum decl~nes ~hile the area of the evacuated area which ~s a "force" increases.
Th'; results ~n a logar~thmic pressure spike applled to the anterior of the vacuum plunger 44 near the closed end 46 of the vacuum chamber 44 This pressure spike ~orks to offset the atmospheric pressure on the poster~or side of the vacuum plunger 48 which results 1n a drop in the bias~ng force on the vacuum plunger 48.
Referring to FIGUR~ 2, the forces applied on the anterior end of the vacuum plunger 48 are seen as a function of the distance along the vacuum chamber 44 that the vacuum plunger 48 travels It is seen that throughout most of this distance a relatively constant, extremely small force (a) ls applied whlch ~esults ln a near constant infusion of the liquid. It is further seen that near the area where the vacuum plunger 48 approaches the closed end 46 of the vacuum chamber 44, the force appl~ed on the anterior of the vacuum plunger 48 spikes upwardly (b) and approaches atmospherlc pressure.
While this phenomena has been recognized in the art, attempts to elim~nate this phenomena ha~e not been sat~sfactory which has resulted in a lack of commercial~zed ~nfusers utilizin3 a vacuum source as a biastng means. ~he attempts ~n the prior art to reckon with this phenomena are pr~marily attempts to perfect the vacuum conta~ned ~n the evacuated area in an attempt to minimize this pressure spike. While these w O 91/16101 2058964 P~/US91~01311 ~
attempts to perfect a vacuum are theoretically possible, in practice such perfection of the vacuum source quickly results in manufacturing techniques such as manufacturing ~n a vacuum ~hich are cost prohibitive to a dlsposable 1nfuser. The present device lO employs means for preloadlng the vacuum which prevents this force from resulting in 1naccurate infusion.
The vacuum plunger 48 is connected to the l~quid plunger 26 by means of a removable support 62 ~hlch extends between the vacuum plunger arm ~8 and the llquid plunger ar~ 36. Thus, bet~een the vacuum plunger 48 and the l~quld plunger 2~, a generally U-shaped arm extends to transfer the force exerted on the vacuum plunger 48 to the liquid plunger 26 to create in the liqu~d chamber 14 a source of pressurized liquid. ~hile ln the presently dep1cted embodlment, thls connectlon is generally lS U-shaped, the present ~nvent~on, of course, contemplates the use of functlonally equlvalent shaped arm and plunger orientations ~hich result ln a functlonal equivalent to the present device.
Referr~ng now to FIGURES 3, 4 and 5, overhead views of the device of FIGURE l are seen. As is seen partlcularly ln FIGURS
3 and 4, the liquid plunger 26 is offset posteriorly from the vacuum plunger 48 a dlstance (d). As ls seen partlcularly ln FIGURE 4, this offset distance (d) results 1n the liquid plunger 26 abutting against the anterior houstng 20 of the liquld chamber 14 before the vacuum plunger 48 abuts agalnst the closed end 46 of the vacuum chamber 44. This distance (d) is referred to herein as the preload distance. Referring to ~IGURE 2, this preload distance (d) is calculated to allo~ infus~on to be com~leted before the vacuum plunger 48 approaches the pressure spike applied on the anterior portion of the vacuum plunger 48.
~hus, by utllizing this preload distance (d), the rate of tnfusion is seen to be relatively constant throughout the entire infusion.
~ O 91/16101 2 0 ~ 8 9 6 ~ PC~r/US91/01311 Referring now to FIGURE ~, the application of this preload distance (d) on the device is descr~bed. The device is seen in storage in which the vacuum plunger 48 as well as the liquid plunger 26 is abutted against the anter~or of the respective chambers 14, 44. Thus, when in storage in this position, nc vacuum or bias is applied to the vacuum plunger 48 and thus the achieved purity of the vacuum is assured dur~ng storage and shipping.
Prior to use of the device 10, the removable support 62 is attached to complete the generally U-shaped arm between the vacuum plunger 48 and the liquid plunger 26. The removable support 62 includes at least one slot 66 (best seen in FIGURE
1), the specific number of which correspond to the specific number of vacuum chambers 44, and defines a posterior 67 and anterior surface 69. Prior to use, the removable support 62 is slid over the vacuum plunger arm 58. The siZe of the slot 6~ i5 sufficiently large to slide over the vacuum plunger arm 58 bu~
is smaller than the diameter of the plunger head 60. Thus, the vacuum plunger head 60 abuts against the posterior surface 67 cf 2Q the removable support 62.
~ he removable support 62 is oriented such that the plunger head 38 of the liquid plunger arm 36 abuts aga~nst the anterior surface 69 of the removable support 62. Thus, when the removable support 62 i5 attached to the device 10, the distance between the vacuum plunger arm 67 and the liquid plunger arm 36 is established as the thickness of the removable support 62.
The removable support 62 in conjunction w~th the plunger arm;
36. 58 and plunger heads 38. 60 act as means for app~ying to a unloaded device a preload to the vacuum source. I~To then load 3Q the infuser, a liquid containing a beneficial agen~ dispersed therein is added under pressure to the liquid chamber 14, the force of which draws the vacuum plunger 48 posteriorly and results in a source of pressuri~ed liquid in the liquid chamber Wo 91/16101 2 0 5 8 9 6 4 PCI/US91/0131 1 Because nature does not know a perfect vacuum, the vacuum plunger 26 will never freely abut against the closed end 46 of the vacuum chamber 44. ~he small dlstance at which the vacuum plunger 26 comes to rest from the closed end-46 of the vacuum chamber 44 is referred to as a tolerance distance (t). This tolerance distance (t) depends on the pur~ty of the vacuum achieved.
The amount of preload distance (d) needed to assure desired accuracy of infusion can be determined as a function of the tolerance dlstance (t). Initially, we know at any g~ven distance of the vacuum plunger 48 along the vacuum chamber 44, the forces exerted on the anter~or and posterior surface of the vacuum plunger 48 must be equal. S1nce f . PV, where P i5 pressure, V ls volume, and f is force, 1t ~s known:
PlVl . P2V2 (l) where Pl is the pressure exerted on the posterior surface of the vacuum plunger 48, P2 is the pressure exerted on the anter~or surface of the vacuum plunger 48. Vl ls the volume of the vacuum chamber 44 posterior to the vacuum plunger 48, and V2 is the volume of the evacuated portion of the vacuum chamber 44.
It is also known that V . (~D2/4)(h) for a cylinder where D
is the diameter and h is the height of the cylinder. Further, the height of the vacuum chamber 44 as a ~hole is x ~ t where x is the length the vacuum plunger travels. Substituting into equation (l), Pl(~D2/4)tt) . P2(~D2/4)(t~x) (2) solving for P2:
P2 - P~ D2/4)(t) 3D (~D2/4)(t~x) 21~589~4 W 0 91/16101 ~ P ~ /US91/01311 cancelling:
P2 - P1(t) (3) (t~x) Further, we can assume that Pl ~s at atmospheric pressure or 14.6960 pslg. Utillzing varlous values for x and t, we obtain the followlng values of P2 ln psig:
DISTANCE DISTANCE t ln ~nches x 1n lnches 0 001 0.002 0.005 0 ol 0.02 3.0 O.OOS 0.010 0.024 0.049 0.097 2.0 0.007 0.015 0.037 0.073 0.146 1.5 0.010 0.020 0.049 0.097 0.193 1.~ 0.015 0.029 0.073 0.146 0.288 0.5 0.029 0.059 0.146 0.288 0.565 0.2 0.073 Q.146 0.358 0.700 1.336 o.l 0.146 0.288 0.700 1.336 2.449 VERIFICATION OF PRESSURE CHANGE WITH PISTON TRAVEL
FORMULA IS P2 - Pl(t)l~t~x) ~hus, when the vacuum plunger 48 ls at various distances (x) along the length of the vacuum chamber 44, the evacuated portion exhlbits the following degree of vacuum:
W O 91/t6101 2 0 5 8 9 6 ~ PC~r/US91/013~`~
DISTANC~ DISTANCE t ln inches x in lnches 0.001 0.002 0.005 0.01 0.02 3.Q 99.97Z 99.93% 99.83X99.67~ 99.347.
2.0 99-95% 99.90% 99.75X99.50Z 99.01%
S 1.5 99.93% 99.8~X 99.67X99.34X 98.68%
1.Q 99.90% 99.B0% 99.50Z 99.01% ' 98.04%
0.5 99.80X 99.60% 99.01X98.04% 96.15%
0.2 99.50'j. 99.01Z 97.56Z95.Z~X 90.91X
0.1 9g.01~ 98.04% 95.24X90.91% 83.33%
DEGR~E OF VACUUM~
~100% represents absolute vacuum B~ utilizing these values, the deslred degree of accuracy can be achieved by knowing the tolerance of manufacture as well as the length of the vacuum chamber 44. ~or example. lf a tolerance of between .001 to .002 lnches ls achleved and an accuracy of ~.5% is desired, approxlmating from TABL~ 2, a preload distance of greater than .5 lnches is requlred.
Addition,ally, as ~s seen the force executed as the vacuum plunger 48 is dependent on the atmospheric pressure executed on the device lQ. To understand how dlfferences ln the atmospheric pressure could affect the present devlce 10, atmospheric conditions were obtained from rhe Natlonal Weather Service for the following sample cities:
~VO 91/16101 2~589 ~ ~ P~/~ISg1/013l 1 Boston Los Anaeles Chicago Denver ELEV~ 15 ft.270 ft. 658 ft. 5,283 ft.
PRESSURE~
MAY~ 1.036 1.019 1.032 .843 MIN .948 .975 .956 .792 AVG 1.001 .997 .980 .823 RANGE~
MID ~4.4% ~2.2% ~3.8% ~3.1%
ATMOSPHERIC CONDITIONS
Above sea level In Atm~s ~- In percentages It i5 thus seen that the changes ~n atmospheric pressure in a given sample city results ~n a maximum change in biasing press,ure of ~4.4Z., which is well within a satisfactory tolerance range of infusion. Additionally, dlfferences ln average atm~spheric pressure for different geograph~c areas can slmpl~
be compensated by adjusting the concentrat~on of benef~c~al 2gent in the medical liquid by a pharmac~st.
Referring nor to FIG~RES 6 through 8, the preferred embodiment of valve means 70 contained in the plug housing 20 cf the,liquid chamber 14 is seen. Referring first to FIGUR~ 7, a plug portion 68 of the valve means 70 in the loading or storagC
mod~ is seen. The valve ~ncludes a connector housing 72 which defines a connector 74. The connector can preferably be 2 female luer, The female luer includes an aperture 76 defined therein which is ln fluid communication with a duck-bill valve 80. The duck-bill valve 80 includes a pair of lip,s 82.
Contained on the downstream side of the duck-bill val~ve 80 ~s an access aperture &3 which is in liquid commun~cation with the interior of the liquid chamber 14. Thus, to load t'he liquid chamber 14, a device such as a svringe capable of providing W O 91tl6101 P ~ /VS91/01311 ~
- 14 _ liquid under pressure and having a cooperating connector such as a male luer is attached to the female luer and the llquid contained within the syringe is expressed under pressure past the duck-bill valve 80 to the interior of the l-~quid thamber 14 to define a source of pressurized liquid. Aftér loading, the duck-bill valve 80 contains the liquid under pressure withln the liquid chamber 14.
Referring now to FIGURE 8. an outlet conduit 84 of the valve means 70 is seen in detail. The tubing 22 is secured to a lG filter housing 86 eontained on the outlet conduit 84 by means such as an adhesive. The filter housing 86 defines a filter aperture which contains a filter 88 in fluid communication with the interior of the tubing 22. The filter 88 is utilized to prevent non-dissolved beneficial agent contained in the medical liquid from enterins the fluid conduit and thus the venous system of the patient. The filter 88 can be preferably made of stainless steel, platinum wire, or other suitable material or of anv of a varietv of polvmers such as polytetrafluoroethylen~
having a porou~ or multifilament configuration capable of operating as a screen and which will be substantially unreactive in the presence of the beneficial agent.
The outlet conduit 84 further includes housing 92 which defines a connector 94 which acts cooperatively with the connector 74 on the plug portion 68. In the preferred embodiment, this cooperating connector 94 is a male luer. The housing further defines an aperture 96 in fluid communication with the filter 88. Extending from the aperture,96 is a blunt cannula 98 defining an internal channel in fluid communication - with the aperture 96.
The blunt cannula 98 extends a distance from the housing 92 which is defined b~ the duck-bill valve 80. Specificall~, The blunt cannula 98 must extend sufficiently from the housing 92 t~
open the duck-bill valve 80 when the connectors 74, 94 are secured. ~hile extending the blunt cannula 98 past the duc~-b _ W O 91/16101 P ~ /US91/01311 valve 80 does satisfactorily open the duck-bill valve 80, it has been found that such extension results in an amount of leakage of the liquid stored in the liquid chamber 14 proportional to the distance past the duck-bill valve 80 that the blunt cannula 98 extends.
Thus~ in a preferred embodiment, the blunt cannula 98 extends into the duck-bill valve 80 sufficiently to separate the lips 82 of the duck-bill valve 80 without penetrating through.
In a further preferred embodiment, the outer periphery of the diluent cannula 98 is about flush with the end of the duck-bill valve 8Q. In this embodiment, small manufacturing tolerances will not appreciably affect the performance of the valve as sufficient penetration is assured to separate the lips 82 but extensive leakage is prevented.
lS After loadins, to use the device 10, the male luer is connected to the female luer. This forces the blunt cannula 9~
into engagement with the duck-bill valve 80. When the male luer and female luer are secured, the open end of the blunt cannula 98 extends into the duck-bill valve 80 to establish fluid 2~! communicatior with the interior of the liquid chamber 14 ~best seen in FiGURE 6). Thus, the liquid under pressure in the liquid chamber 14 rushes into the blunt cannula 98, past the filter 8~, into the tubing 22, and past the flow restrictor 2 contained in the tubing 22 to the patient.
It should be understood that various changes and mo~ifications to the preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminfshing its 3Q attendant advantages. It is, therefore, intended that such changes and modifications be covered by the appended claims.
Claims (9)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A device for infusing liquid comprising:
housing having biasing means containing a source of liquid under pressure, the housing defining an access aperture in fluid communication with the source of pressurized liquid;
a one-way valve contained in the access aperture, the one-way valve adapted to allow liquid under pressure to enter the source of pressurized liquid while retaining the pressurized liquid in the housing; and a separate outlet conduit having a cannula in fluid communication with the outlet conduit, the cannula being adapted to extend sufficiently to open the one-way valve such that upon insertion of the hollow cannula into the one-way valve, fluid communication is established between the outlet conduit and the source of pressurized liquid, said outlet conduit having a flow restrictor.
housing having biasing means containing a source of liquid under pressure, the housing defining an access aperture in fluid communication with the source of pressurized liquid;
a one-way valve contained in the access aperture, the one-way valve adapted to allow liquid under pressure to enter the source of pressurized liquid while retaining the pressurized liquid in the housing; and a separate outlet conduit having a cannula in fluid communication with the outlet conduit, the cannula being adapted to extend sufficiently to open the one-way valve such that upon insertion of the hollow cannula into the one-way valve, fluid communication is established between the outlet conduit and the source of pressurized liquid, said outlet conduit having a flow restrictor.
2. The device of Claim 1 wherein the one-way valve is a duck-bill valve and the hollow cannula is blunt.
3. The device of Claim 2 wherein the duck-bill valve includes inwardly extending lips and the blunt cannula extends internally about equally in distance to the inner periphery of the inwardly extending lips.
4. The device of Claim 1 wherein the housing further includes a connector member and the outlet conduit further includes a cooperating connector member.
5. The device of Claim 4 wherein the connector members are cooperating luer connectors.
6. A valve for use in an ambulatory infusion device having a source of pressurized liquid and defining an access aperture to the source of pressurized liquid, the valve comprising:
an inwardly extending duck-bill valve contained in the access aperture such that liquid under pressure is allowed to enter into the source of pressurized liquid but the pressurized liquid is not allowed to escape; and a separate outlet conduit having a flow restrictor and a blunt cannula, the blunt cannula being adapted to extend into the duck-bill valve at least sufficiently to open the duck-bill valve to establish fluid communication with the source of pressurized liquid and the outlet conduit.
an inwardly extending duck-bill valve contained in the access aperture such that liquid under pressure is allowed to enter into the source of pressurized liquid but the pressurized liquid is not allowed to escape; and a separate outlet conduit having a flow restrictor and a blunt cannula, the blunt cannula being adapted to extend into the duck-bill valve at least sufficiently to open the duck-bill valve to establish fluid communication with the source of pressurized liquid and the outlet conduit.
7. The device of Claim 6 wherein the duck-bill valve includes a pair of inwardly extending lips and the blunt cannula extends inward about equal in distance to the inward periphery of the lips.
8. The device of Claim 6 wherein the access aperture is contained in housing which further defines a connecting member and the outlet conduit further includes a cooperating connecting member.
9. The device of Claim 8 wherein the connecting members are luer connectors.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US7/514,772 | 1990-04-26 | ||
| US07/514,772 US5098385A (en) | 1990-04-26 | 1990-04-26 | Two-way valve for infusion devices |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2058964A1 CA2058964A1 (en) | 1991-10-27 |
| CA2058964C true CA2058964C (en) | 1996-01-09 |
Family
ID=24048625
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002058964A Expired - Fee Related CA2058964C (en) | 1990-04-26 | 1991-02-27 | Two-way valve for infusion devices |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5098385A (en) |
| EP (1) | EP0480015B1 (en) |
| JP (1) | JP3223299B2 (en) |
| CA (1) | CA2058964C (en) |
| DE (1) | DE69114438T2 (en) |
| WO (1) | WO1991016101A1 (en) |
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| US6186982B1 (en) | 1998-05-05 | 2001-02-13 | Elan Corporation, Plc | Subcutaneous drug delivery device with improved filling system |
| US6050978A (en) * | 1997-05-09 | 2000-04-18 | Becton Dickinson And Company | Needleless valve connector |
| US6500150B1 (en) | 1997-06-16 | 2002-12-31 | Elan Pharma International Limited | Pre-filled drug-delivery device and method of manufacture and assembly of same |
| US6029946A (en) * | 1997-09-15 | 2000-02-29 | Tiva Medical Inc. | Needleless valve |
| US6162206A (en) | 1997-12-23 | 2000-12-19 | Baxter International Inc. | Resealable access site |
| US6183461B1 (en) | 1998-03-11 | 2001-02-06 | Situs Corporation | Method for delivering a medication |
| AU2214600A (en) * | 1998-12-29 | 2000-07-31 | Mckinley Medical, Lllp | Spring-powered infusion pump |
| US6348043B1 (en) | 1998-12-29 | 2002-02-19 | Mckinley Medical, Lllp | Multi-dose infusion pump providing minimal flow between doses |
| US6695817B1 (en) | 2000-07-11 | 2004-02-24 | Icu Medical, Inc. | Medical valve with positive flow characteristics |
| US6745998B2 (en) | 2001-08-10 | 2004-06-08 | Alaris Medical Systems, Inc. | Valved male luer |
| US7044441B2 (en) * | 2001-08-10 | 2006-05-16 | Cardinal Health 303, Inc. | Valved male luer connector having sequential valve timing |
| US6964406B2 (en) | 2001-08-10 | 2005-11-15 | Alaris Medical Systems, Inc. | Valved male luer |
| HK1077154A2 (en) | 2003-12-30 | 2006-02-03 | Vasogen Ireland Ltd | Valve assembly |
| US7306566B2 (en) * | 2004-09-15 | 2007-12-11 | Cardinal Health 303, Inc. | Needle free blood collection device with male connector valve |
| ATE542564T1 (en) | 2004-11-05 | 2012-02-15 | Icu Medical Inc | MEDICAL CONNECTOR WITH HIGH FLOW CHARACTERISTICS |
| US7651481B2 (en) * | 2004-12-30 | 2010-01-26 | CareFusion 303 Inc. | Self-sealing male connector device with collapsible body |
| US20070088293A1 (en) * | 2005-07-06 | 2007-04-19 | Fangrow Thomas F Jr | Medical connector with closeable male luer |
| US7998134B2 (en) | 2007-05-16 | 2011-08-16 | Icu Medical, Inc. | Medical connector |
| WO2008052140A2 (en) | 2006-10-25 | 2008-05-02 | Icu Medical, Inc. | Medical connector |
| US9849276B2 (en) | 2011-07-12 | 2017-12-26 | Pursuit Vascular, Inc. | Method of delivering antimicrobial to a catheter |
| US9078992B2 (en) | 2008-10-27 | 2015-07-14 | Pursuit Vascular, Inc. | Medical device for applying antimicrobial to proximal end of catheter |
| US9168366B2 (en) | 2008-12-19 | 2015-10-27 | Icu Medical, Inc. | Medical connector with closeable luer connector |
| US8679090B2 (en) * | 2008-12-19 | 2014-03-25 | Icu Medical, Inc. | Medical connector with closeable luer connector |
| US8454579B2 (en) | 2009-03-25 | 2013-06-04 | Icu Medical, Inc. | Medical connector with automatic valves and volume regulator |
| USD644731S1 (en) | 2010-03-23 | 2011-09-06 | Icu Medical, Inc. | Medical connector |
| JP6058530B2 (en) | 2010-05-06 | 2017-01-11 | アイシーユー・メディカル・インコーポレーテッド | Medical connectors including sealable luer connectors |
| US8758306B2 (en) | 2010-05-17 | 2014-06-24 | Icu Medical, Inc. | Medical connectors and methods of use |
| WO2012162259A2 (en) | 2011-05-20 | 2012-11-29 | Excelsior Medical Corporation | Caps for cannula access devices |
| EP3760275A1 (en) | 2011-09-09 | 2021-01-06 | ICU Medical, Inc. | Medical connectors with fluid-resistant mating interfaces |
| ES2941891T3 (en) | 2013-12-11 | 2023-05-26 | Icu Medical Inc | Retention valve |
| AU2015252808B2 (en) | 2014-05-02 | 2019-02-21 | Excelsior Medical Corporation | Strip package for antiseptic cap |
| USD793551S1 (en) | 2014-12-03 | 2017-08-01 | Icu Medical, Inc. | Fluid manifold |
| USD786427S1 (en) | 2014-12-03 | 2017-05-09 | Icu Medical, Inc. | Fluid manifold |
| EP3294404A4 (en) | 2015-05-08 | 2018-11-14 | ICU Medical, Inc. | Medical connectors configured to receive emitters of therapeutic agents |
| ES2929769T3 (en) | 2016-10-14 | 2022-12-01 | Icu Medical Inc | Disinfectant caps for medical connectors |
| WO2018204206A2 (en) | 2017-05-01 | 2018-11-08 | Icu Medical, Inc. | Medical fluid connectors and methods for providing additives in medical fluid lines |
| US10744992B2 (en) | 2018-05-15 | 2020-08-18 | Robert Bosch Gmbh | Sealing device for a dynamic reservoir |
| US11541220B2 (en) | 2018-11-07 | 2023-01-03 | Icu Medical, Inc. | Needleless connector with antimicrobial properties |
| US11517732B2 (en) | 2018-11-07 | 2022-12-06 | Icu Medical, Inc. | Syringe with antimicrobial properties |
| US11534595B2 (en) | 2018-11-07 | 2022-12-27 | Icu Medical, Inc. | Device for delivering an antimicrobial composition into an infusion device |
| US11400195B2 (en) | 2018-11-07 | 2022-08-02 | Icu Medical, Inc. | Peritoneal dialysis transfer set with antimicrobial properties |
| US11541221B2 (en) | 2018-11-07 | 2023-01-03 | Icu Medical, Inc. | Tubing set with antimicrobial properties |
| US11433215B2 (en) | 2018-11-21 | 2022-09-06 | Icu Medical, Inc. | Antimicrobial device comprising a cap with ring and insert |
| AU2021396147A1 (en) | 2020-12-07 | 2023-06-29 | Icu Medical, Inc. | Peritoneal dialysis caps, systems and methods |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US615751A (en) * | 1898-12-13 | Ernest p | ||
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| US2537585A (en) * | 1947-06-25 | 1951-01-09 | Chain Belt Co | Concrete mixer water injection device |
| US2605784A (en) * | 1948-12-17 | 1952-08-05 | Kenneth M Snider | Check valve |
| US3486539A (en) * | 1965-09-28 | 1969-12-30 | Jacuzzi Bros Inc | Liquid dispensing and metering assembly |
| US3506005A (en) * | 1967-02-23 | 1970-04-14 | Arthur S Gilio | Pressure infusion device for medical use |
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| GB1549402A (en) * | 1976-09-28 | 1979-08-08 | Pye Ltd | Apparatus for delivering fluids with controlled rate of flow |
| US4112949A (en) * | 1976-11-15 | 1978-09-12 | Howmedica Inc. | Apparatus for collecting body fluid |
| US4143853A (en) * | 1977-07-14 | 1979-03-13 | Metatech Corporation | Valve for use with a catheter or the like |
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| US4190206A (en) * | 1978-06-30 | 1980-02-26 | Vernay Laboratories, Inc. | Drip irrigation system |
| US4434810A (en) * | 1980-07-14 | 1984-03-06 | Vernay Laboratories, Inc. | Bi-directional pressure relief valve |
| US4436519A (en) * | 1981-05-28 | 1984-03-13 | Argon Medical Corp. | Removable hemostasis valve |
| US4535818A (en) * | 1983-09-26 | 1985-08-20 | Vernay Laboratories, Inc. | Valve assembly |
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| US4765588A (en) * | 1986-08-18 | 1988-08-23 | Vernay Laboratories, Inc. | Check valve for use with a syringe |
| US4867743A (en) * | 1986-11-24 | 1989-09-19 | Vaillancourt Vincent L | Ambulatory disposable infusion delivery system |
| US4874377A (en) * | 1988-05-26 | 1989-10-17 | Davis Newgard Revocable Family Living Trust | Self-occluding intravascular cannula assembly |
-
1990
- 1990-04-26 US US07/514,772 patent/US5098385A/en not_active Expired - Fee Related
-
1991
- 1991-02-27 DE DE69114438T patent/DE69114438T2/en not_active Expired - Fee Related
- 1991-02-27 WO PCT/US1991/001311 patent/WO1991016101A1/en active IP Right Grant
- 1991-02-27 EP EP91909128A patent/EP0480015B1/en not_active Expired - Lifetime
- 1991-02-27 JP JP50879391A patent/JP3223299B2/en not_active Expired - Fee Related
- 1991-02-27 CA CA002058964A patent/CA2058964C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US5098385A (en) | 1992-03-24 |
| EP0480015A4 (en) | 1992-10-28 |
| EP0480015A1 (en) | 1992-04-15 |
| JPH04506764A (en) | 1992-11-26 |
| CA2058964A1 (en) | 1991-10-27 |
| WO1991016101A1 (en) | 1991-10-31 |
| EP0480015B1 (en) | 1995-11-08 |
| JP3223299B2 (en) | 2001-10-29 |
| DE69114438T2 (en) | 1996-09-05 |
| DE69114438D1 (en) | 1995-12-14 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |