CA2137003A1 - Dual access catheter for implantable pump system - Google Patents
Dual access catheter for implantable pump systemInfo
- Publication number
- CA2137003A1 CA2137003A1 CA 2137003 CA2137003A CA2137003A1 CA 2137003 A1 CA2137003 A1 CA 2137003A1 CA 2137003 CA2137003 CA 2137003 CA 2137003 A CA2137003 A CA 2137003A CA 2137003 A1 CA2137003 A1 CA 2137003A1
- Authority
- CA
- Canada
- Prior art keywords
- catheter
- lumen
- lumens
- pump
- tip
- 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
Links
- 230000009977 dual effect Effects 0.000 title abstract description 8
- 239000012530 fluid Substances 0.000 claims description 11
- 238000004891 communication Methods 0.000 claims description 4
- 230000008878 coupling Effects 0.000 claims description 3
- 238000010168 coupling process Methods 0.000 claims description 3
- 238000005859 coupling reaction Methods 0.000 claims description 3
- 239000004698 Polyethylene Substances 0.000 claims description 2
- -1 polyethylene Polymers 0.000 claims description 2
- 229920000573 polyethylene Polymers 0.000 claims description 2
- 229940079593 drug Drugs 0.000 description 24
- 239000003814 drug Substances 0.000 description 24
- 238000001802 infusion Methods 0.000 description 18
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 12
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 238000000034 method Methods 0.000 description 9
- 102000004877 Insulin Human genes 0.000 description 6
- 108090001061 Insulin Proteins 0.000 description 6
- 229940125396 insulin Drugs 0.000 description 6
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 238000005086 pumping Methods 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 238000011010 flushing procedure Methods 0.000 description 3
- 208000013016 Hypoglycemia Diseases 0.000 description 2
- 241000845077 Iare Species 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 230000002218 hypoglycaemic effect Effects 0.000 description 2
- 241000894007 species Species 0.000 description 2
- GXCDLJXPZVCHBX-UHFFFAOYSA-N 3-methylpent-1-yn-3-yl carbamate Chemical compound CCC(C)(C#C)OC(N)=O GXCDLJXPZVCHBX-UHFFFAOYSA-N 0.000 description 1
- 235000003625 Acrocomia mexicana Nutrition 0.000 description 1
- 244000202285 Acrocomia mexicana Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 241001237728 Precis Species 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 239000010836 blood and blood product Substances 0.000 description 1
- 229940125691 blood product Drugs 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 239000000243 solution Substances 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
-
- 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
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- External Artificial Organs (AREA)
Abstract
2137003 9325262 PCTABS00028 An implantable subsystem (10, 12) using a dual lumen catheter (26') having lumens (27, 44) joined near the distal end (51) to form a single outlet (50). The lumens may be of the same or unequal cross sections. The catheter may be formed in a rigid member (30) having a port body (36) attached to it or integrally formed. The catheter (26') has a first inlet being outlet (42) from cavity (40) of port body (36). The catheter has a second inlet being the output from an implantable pump (10').
Description
~$~D2.` WO 93/2S262 PCr/US93/02X13 ` ` /;;137~93 DUAL ACCESS CATHETER FOR IMPLANTABLE PUMP SYSTEM
Backqround of the Invention This invention relates to implantable devices and, in par~icular, infusion systems.
Speci~lcally, it is directed to a catheter system which is used to provide access to a remote site within a body for pur~oses of infusion of medication, analysis of operation of implantable systems, flushing an implantable device and removal of drug residing therein.
Drug infusion systems have been developed in which a pump is implanted in the body for purposes of~ dispensing metered doses of medication to a selected infusion site. Typically, the pump chamber can be refllled with infusate without the necessity of removing the~pump~itself. This is done by injecting additional material transcutaneousiy through a septum located in the pump. Such pumps which are usedto :~ispens~ medication at a relatively constant flow rate ar~ represented by U.S.
Patents 3,731,681 and 4,~ 93,397.~The devicss have been commercialized as lNFUSAI D
Models 100 and 400. ~
~20 ~ Implantable infusion systems also employ dua! pumping~chambers. This permits the systern to dispense different infusate concentrations or even totai!y different medications to the same or`to different infusion sites within the body. While a common ; system, they~ in essenoe, act as two independent pumps each having its own pumping chamber which can be~purged~and refilled independently of the other. Representative ~ of this type~of pump is U.S. Patent 4,258,711. : ~
Yet~another~kn~wn impiantable infusate system employs a single pumping cha~nber an~ a direct~ln3ection port, which is incorporated as a component~ of the pump. This ~por~ is essentially ~a chamber having an outlet conduit leading to an infusion oite in ~the patien~s~ body; and ~an inlet port olosed~by a needle-penetrable 30 ~ ~septu:m located undemeath the patient's skin, which is accessible by transcutaneou~
In this~ type ~of device, ~a constant flouY of in~usate is obtained by means of the pump. If a bolus or suppl~ment~l dose is requir~d- such is administered by percutan~ous injection into the port. ~ Sueh a device can be used for ancillary purposes, 35 such as blood withdrawal, can be ~subje~ed to sophisticated analysi external to the pump ~self to dderrnine overali oper~tion of the system. Representative of such a , W~ 93~25262 ~ ' 3 PCr/US93/028 device is U.S. Patent 4,496,343. It employs a single catheter with the sideport T-ed into the pump outlet.
A system which employs a pump and side port combination for diagnostic purposes is found in U.S. Patent ~,006,~97. By using the existing irnplanted hardware 5 coupled to extemal diagnostic equipment the working condition of the pump and catheter can be ascertained.
In some instsnces, a patient's drug protocol may call for the injection of two different drugs over a long period of time. A plurality of ports may therefore be irnplanted so that one particular drug can be supplied to two different sit~s within the 10 body, or that different drugs can be routed to the same infusion site without contamina~ion.
Consequently, within the art a number of proposals exist that use catheters having a plurality ot lumens. Two alternatives are ill~strated in U.S. Patent 4,931,050, in particular, in Figs. 4B and 4C thereof. As illustrated thenoin, one alternative is an 15 ancillary port coupled to: one lurnen of a catheter with the other lumen coupled to the pump. Thus, two parallel drug infusiorl routes exist using a common catheter having two lumens. A va~riation is iliustrated in Fig. 4C wherein two ports are used, one providing direot access to a iumen of the catheter while the other is T-ed to the pump ~ and to the second independent lumen.
20 ~ ~ Multiple port arrangements having parailel catheter devices are illustrated, for example, in U.S. Patents 4,673,394, 4,6g2,146, 4,710,174 and 4,892,518. The lumens in some cases iare separated by a common wall within a single tube, two distinct tubes, or two pariallel tube ~lements encas@d in a single catheter housing. For example, the '394 patent empioys:a p~ir of po~ts each with its own outlet catheter. The ca~heters in the '174 patent i~e separated from each other. : -F~r exarnple, afigure esght (8) doubl~ iurnen catheter is disclosed in U.S. Patent 4,405,313. Such a c~theter is a side by side system with two tlJbes a~tached together :
to provicle multi pUl'pO5e venous acc~ss such that blood product and medic~tion can b~ sirnultan~ously appiied. The two lumens iare connected and bridgQd by a smoothly tap~red filler so that ~ unitary oatheter is defined even though the lumens may have .
unequal diameters. Thus, a single catheter body has two lumens.
Other muitiple lumen systems are disclosed in U.S. Patents 4,639,24~ and :~ ~ 4,95~,861. For exarnple, in the '861 patent a tapered concentric system i5 disclosed :
`. WO 9~/~!;262 PCr/l lS93/02X1 3 t, ~ 7 ~! ~ 3 which aJlows multiple delivery simultaneously into an implantable pump having two dmersnt reservoirs.
While these prior art systems offer various advantages in terms of muitiple drugdelivery to the same or different sites and the ability to perforrn various diagnostic tests, 5 none provide direct port access to the ca~heter tip as well as the side port catheter.
Surnmarv of the Lnvention It is an object of this invention to provide a catheter configuration which provides clinical flexibility for operations employing implantable pumps.
Another object of this invention is to provide for a catheter configuration which tû allows tip pateney to be evaluated without the necessity ef a drug being infused into the patient.
Yet another obj~ct o~ this invention is to provide a cathet~r system wherein blockage a~ the tip can be flushed without drug infusion into the patient. It is also : desirab!~ to have a systern which allows the withdrawal of blood samples without the 15 risk of blockage in either the sideport or along the catheter lumen exiting from the sideport. Thus, an object of thi~ invention is to provid~ a oatheter system whîch permits withdrawal of fluids from ~he body without adversely effecting overall operation : ~ of the pump syster~. ~
These and other oblects of this invention are accomplished by means of a dual 2 0 aceess c~heter system which ~employs a double lumen cathet~r with the two lumens joined ltog~her proximal to the tip to form a short single lumen at the distal end. The catheter may be forrnad as an integral ~init having the lumens ther~in and provided with various flange elements for purposes o~ anchoring the llnit. It may also be formed with an integral port or, have a surface upon which the port is mounted with an outlet thereof and fluid communic~tion with one of the lumens. The lumens may have the same or d~ferent intemal di meters. If needed, a iiner for one of the lumens may also be employed.
~: This invention will be described in greater detail by r~erring to the a~tached drawing and the description ot the pr~ferred embodiment which ~ollows.
: 30 ~ ~ ~o~9L~
Fig. 1 is a schematic view of a dual acces~ ca~heter system in accordance with this invention; and :
wO93/25262 ~ 37~~ Pcr/US93/028~
Fig. 2 is an enlarged schematic cut away showing the distal end of the dua lumen catheter.
Description of the Pr~erred Embodiment Pseferring now to Fig. 1, the essentia~ system components o~ this invention are 5 depicted. The two major components are the pump subsystem 10 and the catheter subsystem 12. The pump subsystem 10 may be any commercially available infusion system, such as the INFI )SAIl:~ Model 400, which employs a side port. The purnp may be const~t flow device or any flow metering or other pumping system, such as a programmable valve system, as illustrated in U.S. Patent 4,838,887.
~ Typically, such systems have a pump 10' a refill septum 14 and a drug TeseNoir~
schematically illust~rated as element 16. Not illustr~ted in Fig. 1 is the outlet from the drug reserYoir 16 to an infusion site. Such devices also employ a sideport 18 having a septum 20 and an ouUet catheter. A connector, typically ~ purnp catheter connector ; 22, couples both the reservoir 16 and the side port 20 to the infusion site.
15~ ~he cath6ter connector has a positive coupling plug connector 24 to establish ~ a iockable connection between the catheter and the pump. It will be understood that :: : this~ assembly can,: o7 course, be disconnected to allow ancillary or replacement :: components to be attached to the pump subsystem 10.: The catheter subsystem 12, : : in a first portion, compnses a c~theter body (26) having a bore or lumen 27 and a liner, 20 ~ypicaJly polyethyll3ne 28. :
In accordanc~ with this invention, the catheter 26 is joined ~o the dual access:catheter~subsyst~m 12. The catheter subsystem 12, in a sec~rld :portion, comprises :a dual lumsn catheter 26'. A ;rigid ~support member or flange 30 provides a support 70r ;flange~h~ving ~suture holes 32.: It~will be understoo~ that the number of suture holes 25 and their plac2mene vary as a ~ncffon of size and: application of this device. ;Also, ~he ~` ~; ' flange ~an be made to any conformal shape. Mounted ors the support 30 is ia tip access~poFt 34. The access p:~rt 34 has a body member:36, a penetrable septum 38nd a sm~l cavity 40. The outlet of~the cwity 40 is in the form of a conduit 42 coupled to a bore ~or lumen 44. Lumen 44 and ;the catheter 26' may be housad in a rigid body 30 46. The rigi~ body 46 is~ integral with the support 30 in this embodiment. However, it m y be made as separate elements.~ ~
The lumen 44 terminates ~near the distall end by convsrgence and merges with lumen 27 within catheter 26'. This is illustràted schematically as a bend or convergence WO 93/2~262 .; 1 ~ 7 0 û 3 PCr/US93/02813 zone 48. It will be appreciated that other geometries may be utilized to achieveconv~rgence of the two lumens. The distal end 51 thus terminates in a single catheter tip or outlet 50. If necessary, the catheter may be extended by means of a shortflexible tube.
Also, while illustrated as a unitary rigid element, it is apparent that the duallumen catheter extension may be flexible itself and formed, for example, out of silicon attached in a convenient manner to the support 30.
Figure 2 shows such a flexible system. The catheter 26' having body 52 may b: mad~ of a flexible m~terial, such as a silicone rubber or the like. The lumen coupled to the side port 18 rnay be coated with a liner 28' such as polyethylene. Such a liner ean be used if the system is using particuiar fluids. It may have an inside diameter greater than that of the lumen 44, which is in fluid communication with the tip access port 34. The cross-sectiona! configuration is a function of operational mode although different cross-s~ctions add a dcgree of safPtY to the device. The bend or convergence zone 48 is illustrated proximal to the tip or outlet 500 In operation, the system provides an addltional level of versatiiity for the clinician. Operation for purposes of dispensing infusate from the pump 10' through the catheter is unaffected. Likewise, bolus injections~from the side port 18 are conducted as in a conventiorl~l system. However,~ utili2ing the tip access port 34 in combination 20 ~ with the~dual !umen cath~ter a nurnber of additional advantages occur.
First, tip paterlcy at the outlet 50 can be eYaluated without a drug being infused into the system. Uslng techniques, as disclosed in U.S. Patent 5j006,997, dealing with a ~pump diagnostic device (PDD), tip patency can be assessed utilizin~ the tip access por~ 34. 1~ wi!l be appreciated that utilizing those sarne t~chniques the cathet~r 26 25 ~xiting the pump sid~port 1~ can b~ evaluat~d for patency utilizing the sideport itself.
, ~ ~ This system thus pe~its a determination of pa~ency at the tip. Such is important because that is a~source of blockage in many applications.
A drug which resides in th~ catheter 26 exiting the side port 18 :can be~ removed without infusing drug into the patie~nt. This oan be done utilizing both the side port 1 30 snd the :tip aocess port 34. By a~taching a drain line to the sideport and an infusion line t o the tip access port, the drug can be removed from the catheter without bodily fluids entenng the catheter. That is,: a flushing fluid Is introduced via the lumen 44.
W0 ~3/25262 PCI/US93/028~''-';' 3 ~ ~ ~3 3 Since a drain line is ~ached to the side port, a pressure differential exists in the two lumens with the lower pressure in the catheter 26. A fluid communioation ioop is thus esta~lished without bodily lfluid entering the catheter tip 50.
Another important advantage is that blockage at the catheter tip 60 can be 5 fiushed via the tip access port 34 without drug infusion into the patient. This is done by direct flushing utilizing the lumen 44 which, as illustrated in Figs. 1 and 2, merges with the lumen 27 carrying the drug approxima to the tip 50.
A reverse application is the withdrawa of blood sampies or any othPr bodily fluids utilizing the tip access port 34. This can be done utilizing the lumen 44 without 10 risking any blockages in the sideport 18: or along the oatheter lumen exiting the sideport. By this technique the catheter 26 is maintained in a drug c3elivery mode.
The tip access port 34 can also be used itself as a sideport1 that is, it can beemployed for a bo!us injection of a drug different from ene existing in the pumpreservoir without disturbing the drug and the catheter lumen exiting the sideport 18.
15It will be recognized by one of working skill that the system defined by this inv0ntion requires a surgic~ implant procedure that has associated with it additional stops.: Thus, in addition to implanting the pump subassembly and the catheter, the tip access port 34 ~3so requires implantation. The p:a~ient is thus provided with three distinct needle aocass~ sites. ~ This may offer a degree of inconvenience to the patient 20 but provides, as explained hereirl, a rnuch higher degree of flexibility to the clinician.
.
: Addition~lly, because the catheter has two discreet lumens it would have a slightly larger effective size. However, the inconveniences of irnplantation, are more than ovorcome by ~the ~dvantages ~f this system.
One of the key ~dvantages is used in an appiication involYing insulin. As will 25 i~e appreciated, the~infusion of insulin requires speci~ hand!ing: given the nature of tha~
matenal. MoreovQr, ghen the: nature of the disease ana the propensHy for hypoglycemia during Yar;it:~US proce~dures, this invention offers sorne unique advantages.
For example, catheter ~tip ~evaluations can be performed without the risk of hypogly~emia by ~ izing the PDDtechniques 3irected to thetip access port ~4. This 30~ greatly shortens the procedure because the patient will not have to be m~nitored for a protracted length of time, for exampie, 4 hours as is the current regime. mportantiy, the procedure does not involve any infusion of insulin, which is especially important for a britt3e diabetic. ~: ~
~ WO 93/2526~ PC~/US93J02813 7D~3 Insulin ean be removed from the catheter lumen 27 attached to the sideport, as weli as the side port lumen proxim~ to the catheter by utilizing the tip access port 34 and the sidepo~t 18. In this application drainage would be at the sideport 18 and infusion would be at the tip access port 34.
For exampie, insulin removaJ is required prior to the alkaline flush during a magnet procedure. This procedure is one that employs a magnet placed over a pumphaving valves that open and closa such as an Infusaid M1000 (see also U.S. Patent 4,838,887). The magnet holds both inlet an~ outlet valves open An alkaline flushsolution is loaded into the pump 10' and extracted Yla the sideport 18 through septurn 10 : 20. The ~kaline solution dissolves any preci~itation within the pump flow path. Again, this insulin removal technique prevents hypoglycernia.
Alkaline pump flushes can also be performed with increased safety. While utiliziny the magnet to fiush NaOH through the pump, the tip access port 34 can be used to inh~se a clilutent to the catheter tip 50. Thus, in the case ~f an accidental 15 NaOH infusion the dilutent being infused into the tip access port 34 will deactivate the NaOH prior to ex-rting the catheter tip.
The system can :also be used in an emergency mode. For a diabetic patient who is experiencing severe;hypoglycemia during a procedure, the clinician can infuse dextrose dircctly: into the tip access port to expedit2 rapid recovery.
2 0 ~ ~ : I t will be appreciated that modiflcations of this invention are within the purview :: and scopethereof. ~ :
: ~ : ~ `:
``: :` : : :
::
`~
~: :
~: - :
Backqround of the Invention This invention relates to implantable devices and, in par~icular, infusion systems.
Speci~lcally, it is directed to a catheter system which is used to provide access to a remote site within a body for pur~oses of infusion of medication, analysis of operation of implantable systems, flushing an implantable device and removal of drug residing therein.
Drug infusion systems have been developed in which a pump is implanted in the body for purposes of~ dispensing metered doses of medication to a selected infusion site. Typically, the pump chamber can be refllled with infusate without the necessity of removing the~pump~itself. This is done by injecting additional material transcutaneousiy through a septum located in the pump. Such pumps which are usedto :~ispens~ medication at a relatively constant flow rate ar~ represented by U.S.
Patents 3,731,681 and 4,~ 93,397.~The devicss have been commercialized as lNFUSAI D
Models 100 and 400. ~
~20 ~ Implantable infusion systems also employ dua! pumping~chambers. This permits the systern to dispense different infusate concentrations or even totai!y different medications to the same or`to different infusion sites within the body. While a common ; system, they~ in essenoe, act as two independent pumps each having its own pumping chamber which can be~purged~and refilled independently of the other. Representative ~ of this type~of pump is U.S. Patent 4,258,711. : ~
Yet~another~kn~wn impiantable infusate system employs a single pumping cha~nber an~ a direct~ln3ection port, which is incorporated as a component~ of the pump. This ~por~ is essentially ~a chamber having an outlet conduit leading to an infusion oite in ~the patien~s~ body; and ~an inlet port olosed~by a needle-penetrable 30 ~ ~septu:m located undemeath the patient's skin, which is accessible by transcutaneou~
In this~ type ~of device, ~a constant flouY of in~usate is obtained by means of the pump. If a bolus or suppl~ment~l dose is requir~d- such is administered by percutan~ous injection into the port. ~ Sueh a device can be used for ancillary purposes, 35 such as blood withdrawal, can be ~subje~ed to sophisticated analysi external to the pump ~self to dderrnine overali oper~tion of the system. Representative of such a , W~ 93~25262 ~ ' 3 PCr/US93/028 device is U.S. Patent 4,496,343. It employs a single catheter with the sideport T-ed into the pump outlet.
A system which employs a pump and side port combination for diagnostic purposes is found in U.S. Patent ~,006,~97. By using the existing irnplanted hardware 5 coupled to extemal diagnostic equipment the working condition of the pump and catheter can be ascertained.
In some instsnces, a patient's drug protocol may call for the injection of two different drugs over a long period of time. A plurality of ports may therefore be irnplanted so that one particular drug can be supplied to two different sit~s within the 10 body, or that different drugs can be routed to the same infusion site without contamina~ion.
Consequently, within the art a number of proposals exist that use catheters having a plurality ot lumens. Two alternatives are ill~strated in U.S. Patent 4,931,050, in particular, in Figs. 4B and 4C thereof. As illustrated thenoin, one alternative is an 15 ancillary port coupled to: one lurnen of a catheter with the other lumen coupled to the pump. Thus, two parallel drug infusiorl routes exist using a common catheter having two lumens. A va~riation is iliustrated in Fig. 4C wherein two ports are used, one providing direot access to a iumen of the catheter while the other is T-ed to the pump ~ and to the second independent lumen.
20 ~ ~ Multiple port arrangements having parailel catheter devices are illustrated, for example, in U.S. Patents 4,673,394, 4,6g2,146, 4,710,174 and 4,892,518. The lumens in some cases iare separated by a common wall within a single tube, two distinct tubes, or two pariallel tube ~lements encas@d in a single catheter housing. For example, the '394 patent empioys:a p~ir of po~ts each with its own outlet catheter. The ca~heters in the '174 patent i~e separated from each other. : -F~r exarnple, afigure esght (8) doubl~ iurnen catheter is disclosed in U.S. Patent 4,405,313. Such a c~theter is a side by side system with two tlJbes a~tached together :
to provicle multi pUl'pO5e venous acc~ss such that blood product and medic~tion can b~ sirnultan~ously appiied. The two lumens iare connected and bridgQd by a smoothly tap~red filler so that ~ unitary oatheter is defined even though the lumens may have .
unequal diameters. Thus, a single catheter body has two lumens.
Other muitiple lumen systems are disclosed in U.S. Patents 4,639,24~ and :~ ~ 4,95~,861. For exarnple, in the '861 patent a tapered concentric system i5 disclosed :
`. WO 9~/~!;262 PCr/l lS93/02X1 3 t, ~ 7 ~! ~ 3 which aJlows multiple delivery simultaneously into an implantable pump having two dmersnt reservoirs.
While these prior art systems offer various advantages in terms of muitiple drugdelivery to the same or different sites and the ability to perforrn various diagnostic tests, 5 none provide direct port access to the ca~heter tip as well as the side port catheter.
Surnmarv of the Lnvention It is an object of this invention to provide a catheter configuration which provides clinical flexibility for operations employing implantable pumps.
Another object of this invention is to provide for a catheter configuration which tû allows tip pateney to be evaluated without the necessity ef a drug being infused into the patient.
Yet another obj~ct o~ this invention is to provide a cathet~r system wherein blockage a~ the tip can be flushed without drug infusion into the patient. It is also : desirab!~ to have a systern which allows the withdrawal of blood samples without the 15 risk of blockage in either the sideport or along the catheter lumen exiting from the sideport. Thus, an object of thi~ invention is to provid~ a oatheter system whîch permits withdrawal of fluids from ~he body without adversely effecting overall operation : ~ of the pump syster~. ~
These and other oblects of this invention are accomplished by means of a dual 2 0 aceess c~heter system which ~employs a double lumen cathet~r with the two lumens joined ltog~her proximal to the tip to form a short single lumen at the distal end. The catheter may be forrnad as an integral ~init having the lumens ther~in and provided with various flange elements for purposes o~ anchoring the llnit. It may also be formed with an integral port or, have a surface upon which the port is mounted with an outlet thereof and fluid communic~tion with one of the lumens. The lumens may have the same or d~ferent intemal di meters. If needed, a iiner for one of the lumens may also be employed.
~: This invention will be described in greater detail by r~erring to the a~tached drawing and the description ot the pr~ferred embodiment which ~ollows.
: 30 ~ ~ ~o~9L~
Fig. 1 is a schematic view of a dual acces~ ca~heter system in accordance with this invention; and :
wO93/25262 ~ 37~~ Pcr/US93/028~
Fig. 2 is an enlarged schematic cut away showing the distal end of the dua lumen catheter.
Description of the Pr~erred Embodiment Pseferring now to Fig. 1, the essentia~ system components o~ this invention are 5 depicted. The two major components are the pump subsystem 10 and the catheter subsystem 12. The pump subsystem 10 may be any commercially available infusion system, such as the INFI )SAIl:~ Model 400, which employs a side port. The purnp may be const~t flow device or any flow metering or other pumping system, such as a programmable valve system, as illustrated in U.S. Patent 4,838,887.
~ Typically, such systems have a pump 10' a refill septum 14 and a drug TeseNoir~
schematically illust~rated as element 16. Not illustr~ted in Fig. 1 is the outlet from the drug reserYoir 16 to an infusion site. Such devices also employ a sideport 18 having a septum 20 and an ouUet catheter. A connector, typically ~ purnp catheter connector ; 22, couples both the reservoir 16 and the side port 20 to the infusion site.
15~ ~he cath6ter connector has a positive coupling plug connector 24 to establish ~ a iockable connection between the catheter and the pump. It will be understood that :: : this~ assembly can,: o7 course, be disconnected to allow ancillary or replacement :: components to be attached to the pump subsystem 10.: The catheter subsystem 12, : : in a first portion, compnses a c~theter body (26) having a bore or lumen 27 and a liner, 20 ~ypicaJly polyethyll3ne 28. :
In accordanc~ with this invention, the catheter 26 is joined ~o the dual access:catheter~subsyst~m 12. The catheter subsystem 12, in a sec~rld :portion, comprises :a dual lumsn catheter 26'. A ;rigid ~support member or flange 30 provides a support 70r ;flange~h~ving ~suture holes 32.: It~will be understoo~ that the number of suture holes 25 and their plac2mene vary as a ~ncffon of size and: application of this device. ;Also, ~he ~` ~; ' flange ~an be made to any conformal shape. Mounted ors the support 30 is ia tip access~poFt 34. The access p:~rt 34 has a body member:36, a penetrable septum 38nd a sm~l cavity 40. The outlet of~the cwity 40 is in the form of a conduit 42 coupled to a bore ~or lumen 44. Lumen 44 and ;the catheter 26' may be housad in a rigid body 30 46. The rigi~ body 46 is~ integral with the support 30 in this embodiment. However, it m y be made as separate elements.~ ~
The lumen 44 terminates ~near the distall end by convsrgence and merges with lumen 27 within catheter 26'. This is illustràted schematically as a bend or convergence WO 93/2~262 .; 1 ~ 7 0 û 3 PCr/US93/02813 zone 48. It will be appreciated that other geometries may be utilized to achieveconv~rgence of the two lumens. The distal end 51 thus terminates in a single catheter tip or outlet 50. If necessary, the catheter may be extended by means of a shortflexible tube.
Also, while illustrated as a unitary rigid element, it is apparent that the duallumen catheter extension may be flexible itself and formed, for example, out of silicon attached in a convenient manner to the support 30.
Figure 2 shows such a flexible system. The catheter 26' having body 52 may b: mad~ of a flexible m~terial, such as a silicone rubber or the like. The lumen coupled to the side port 18 rnay be coated with a liner 28' such as polyethylene. Such a liner ean be used if the system is using particuiar fluids. It may have an inside diameter greater than that of the lumen 44, which is in fluid communication with the tip access port 34. The cross-sectiona! configuration is a function of operational mode although different cross-s~ctions add a dcgree of safPtY to the device. The bend or convergence zone 48 is illustrated proximal to the tip or outlet 500 In operation, the system provides an addltional level of versatiiity for the clinician. Operation for purposes of dispensing infusate from the pump 10' through the catheter is unaffected. Likewise, bolus injections~from the side port 18 are conducted as in a conventiorl~l system. However,~ utili2ing the tip access port 34 in combination 20 ~ with the~dual !umen cath~ter a nurnber of additional advantages occur.
First, tip paterlcy at the outlet 50 can be eYaluated without a drug being infused into the system. Uslng techniques, as disclosed in U.S. Patent 5j006,997, dealing with a ~pump diagnostic device (PDD), tip patency can be assessed utilizin~ the tip access por~ 34. 1~ wi!l be appreciated that utilizing those sarne t~chniques the cathet~r 26 25 ~xiting the pump sid~port 1~ can b~ evaluat~d for patency utilizing the sideport itself.
, ~ ~ This system thus pe~its a determination of pa~ency at the tip. Such is important because that is a~source of blockage in many applications.
A drug which resides in th~ catheter 26 exiting the side port 18 :can be~ removed without infusing drug into the patie~nt. This oan be done utilizing both the side port 1 30 snd the :tip aocess port 34. By a~taching a drain line to the sideport and an infusion line t o the tip access port, the drug can be removed from the catheter without bodily fluids entenng the catheter. That is,: a flushing fluid Is introduced via the lumen 44.
W0 ~3/25262 PCI/US93/028~''-';' 3 ~ ~ ~3 3 Since a drain line is ~ached to the side port, a pressure differential exists in the two lumens with the lower pressure in the catheter 26. A fluid communioation ioop is thus esta~lished without bodily lfluid entering the catheter tip 50.
Another important advantage is that blockage at the catheter tip 60 can be 5 fiushed via the tip access port 34 without drug infusion into the patient. This is done by direct flushing utilizing the lumen 44 which, as illustrated in Figs. 1 and 2, merges with the lumen 27 carrying the drug approxima to the tip 50.
A reverse application is the withdrawa of blood sampies or any othPr bodily fluids utilizing the tip access port 34. This can be done utilizing the lumen 44 without 10 risking any blockages in the sideport 18: or along the oatheter lumen exiting the sideport. By this technique the catheter 26 is maintained in a drug c3elivery mode.
The tip access port 34 can also be used itself as a sideport1 that is, it can beemployed for a bo!us injection of a drug different from ene existing in the pumpreservoir without disturbing the drug and the catheter lumen exiting the sideport 18.
15It will be recognized by one of working skill that the system defined by this inv0ntion requires a surgic~ implant procedure that has associated with it additional stops.: Thus, in addition to implanting the pump subassembly and the catheter, the tip access port 34 ~3so requires implantation. The p:a~ient is thus provided with three distinct needle aocass~ sites. ~ This may offer a degree of inconvenience to the patient 20 but provides, as explained hereirl, a rnuch higher degree of flexibility to the clinician.
.
: Addition~lly, because the catheter has two discreet lumens it would have a slightly larger effective size. However, the inconveniences of irnplantation, are more than ovorcome by ~the ~dvantages ~f this system.
One of the key ~dvantages is used in an appiication involYing insulin. As will 25 i~e appreciated, the~infusion of insulin requires speci~ hand!ing: given the nature of tha~
matenal. MoreovQr, ghen the: nature of the disease ana the propensHy for hypoglycemia during Yar;it:~US proce~dures, this invention offers sorne unique advantages.
For example, catheter ~tip ~evaluations can be performed without the risk of hypogly~emia by ~ izing the PDDtechniques 3irected to thetip access port ~4. This 30~ greatly shortens the procedure because the patient will not have to be m~nitored for a protracted length of time, for exampie, 4 hours as is the current regime. mportantiy, the procedure does not involve any infusion of insulin, which is especially important for a britt3e diabetic. ~: ~
~ WO 93/2526~ PC~/US93J02813 7D~3 Insulin ean be removed from the catheter lumen 27 attached to the sideport, as weli as the side port lumen proxim~ to the catheter by utilizing the tip access port 34 and the sidepo~t 18. In this application drainage would be at the sideport 18 and infusion would be at the tip access port 34.
For exampie, insulin removaJ is required prior to the alkaline flush during a magnet procedure. This procedure is one that employs a magnet placed over a pumphaving valves that open and closa such as an Infusaid M1000 (see also U.S. Patent 4,838,887). The magnet holds both inlet an~ outlet valves open An alkaline flushsolution is loaded into the pump 10' and extracted Yla the sideport 18 through septurn 10 : 20. The ~kaline solution dissolves any preci~itation within the pump flow path. Again, this insulin removal technique prevents hypoglycernia.
Alkaline pump flushes can also be performed with increased safety. While utiliziny the magnet to fiush NaOH through the pump, the tip access port 34 can be used to inh~se a clilutent to the catheter tip 50. Thus, in the case ~f an accidental 15 NaOH infusion the dilutent being infused into the tip access port 34 will deactivate the NaOH prior to ex-rting the catheter tip.
The system can :also be used in an emergency mode. For a diabetic patient who is experiencing severe;hypoglycemia during a procedure, the clinician can infuse dextrose dircctly: into the tip access port to expedit2 rapid recovery.
2 0 ~ ~ : I t will be appreciated that modiflcations of this invention are within the purview :: and scopethereof. ~ :
: ~ : ~ `:
``: :` : : :
::
`~
~: :
~: - :
Claims
WO 93/25262 PCT/US93/028??
1. A catheter comprising:
a body having a distal end and at least two separate internal lumens, means inside said body for coupling one lumen to be in fluid communication with the other lumen, and an outlet at said distal end for the other lumen.
2. The catheter of claim 1 wherein said body further comprises a support member having suture holes to anchor said body inside a bodily cavity.
3. The catheter of claim 1 further comprising a first access port to provide a fluid input to one of said lumens and a second access port to provide fluid input to the other of said lumens.
4. The catheter of claim 1 wherein said means inside said body comprises a bend in said one lumen to join it to said other lumen.
5. The catheter of claim 4 wherein said bend of said one lumen is proximal to said outlet.
6. The catheter of claim 1 wherein the cross sectional area of said one lumen is different from the cross sectional area of said other lumen.
7. The catheter of claim 1 further comprising an implantable pump, a connector for said other lumen to couple it in fluid communication to said implantable pump, and a separate access port coupled in fluid communication to said one lumen.
8. The catheter of claim 7 further comprising means for coupling said body to living tissue and wherein said separate access and said means to couple said body are integral to each other and also contain said one lumen and said other lumen.9. The catheter of claim 7 wherein said means inside said body comprises a convergence zone proximate said distal end to join said one lumen and said other lumen.
10. The catheter of claim 9 further comprising a polyethylene liner extending in one of said lumens substantially to said convergence zone.
1. A catheter comprising:
a body having a distal end and at least two separate internal lumens, means inside said body for coupling one lumen to be in fluid communication with the other lumen, and an outlet at said distal end for the other lumen.
2. The catheter of claim 1 wherein said body further comprises a support member having suture holes to anchor said body inside a bodily cavity.
3. The catheter of claim 1 further comprising a first access port to provide a fluid input to one of said lumens and a second access port to provide fluid input to the other of said lumens.
4. The catheter of claim 1 wherein said means inside said body comprises a bend in said one lumen to join it to said other lumen.
5. The catheter of claim 4 wherein said bend of said one lumen is proximal to said outlet.
6. The catheter of claim 1 wherein the cross sectional area of said one lumen is different from the cross sectional area of said other lumen.
7. The catheter of claim 1 further comprising an implantable pump, a connector for said other lumen to couple it in fluid communication to said implantable pump, and a separate access port coupled in fluid communication to said one lumen.
8. The catheter of claim 7 further comprising means for coupling said body to living tissue and wherein said separate access and said means to couple said body are integral to each other and also contain said one lumen and said other lumen.9. The catheter of claim 7 wherein said means inside said body comprises a convergence zone proximate said distal end to join said one lumen and said other lumen.
10. The catheter of claim 9 further comprising a polyethylene liner extending in one of said lumens substantially to said convergence zone.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US89947592A | 1992-06-16 | 1992-06-16 | |
| US899,475 | 1992-06-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2137003A1 true CA2137003A1 (en) | 1993-12-23 |
Family
ID=25411052
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2137003 Abandoned CA2137003A1 (en) | 1992-06-16 | 1993-04-02 | Dual access catheter for implantable pump system |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP0680352A1 (en) |
| JP (1) | JP2744911B2 (en) |
| CA (1) | CA2137003A1 (en) |
| DE (1) | DE9390130U1 (en) |
| WO (1) | WO1993025262A1 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5527307A (en) | 1994-04-01 | 1996-06-18 | Minimed Inc. | Implantable medication infusion pump with discharge side port |
| GB9626815D0 (en) * | 1996-12-23 | 1997-02-12 | Cemu Bioteknik Ab | Method of sequencing DNA |
| US8062269B2 (en) | 2006-06-09 | 2011-11-22 | Baxter International Inc. | Fail safe dual chamber peritoneal dialysis/infusion system |
| JP5372166B2 (en) * | 2008-11-10 | 2013-12-18 | メド−エル エレクトロメディジニシェ ゲラテ ゲーエムベーハー | Implantable refillable drug delivery container |
| EP2803376A1 (en) * | 2013-05-16 | 2014-11-19 | Georg Fischer | Novel active emergency supply valve |
| DE102020104235A1 (en) | 2020-02-18 | 2021-08-19 | Tricumed Medizintechnik Gmbh | Port catheter |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3731681A (en) | 1970-05-18 | 1973-05-08 | Univ Minnesota | Implantable indusion pump |
| US4193397A (en) | 1977-12-01 | 1980-03-18 | Metal Bellows Corporation | Infusion apparatus and method |
| DE2929562C3 (en) * | 1978-07-20 | 1982-03-11 | Olympus Optical Co., Ltd., Tokyo | Medical instrument with a tubular sheath that can be introduced into a human body cavity |
| US4258711A (en) | 1979-02-05 | 1981-03-31 | Metal Bellows Corporation | Infusion apparatus and method |
| DE3713061A1 (en) * | 1986-05-02 | 1987-11-05 | Siemens Ag | Medicament metering device implantable into the body of a patient |
| DE3787011T2 (en) * | 1987-01-06 | 1994-03-10 | Advanced Cardiovascular System | Dilatation catheter with a thin guide wire. |
| US4838887A (en) | 1987-12-15 | 1989-06-13 | Shiley Infusaid Inc. | Programmable valve pump |
| US4931050A (en) * | 1988-04-13 | 1990-06-05 | Shiley Infusaid Inc. | Constant pressure variable flow pump |
| AT397911B (en) * | 1990-07-04 | 1994-08-25 | Avl Verbrennungskraft Messtech | TWO TUMBLE NEEDLE FOR BODY LIQUIDS |
| US5178612A (en) * | 1990-10-10 | 1993-01-12 | Strato Medical Corporation | Compressible split cylinder bayonet locking device for attachment of a catheter to a fluid transfer device |
| US5219335A (en) * | 1991-05-23 | 1993-06-15 | Scimed Life Systems, Inc. | Intravascular device such as introducer sheath or balloon catheter or the like and methods for use thereof |
-
1993
- 1993-04-02 EP EP93909172A patent/EP0680352A1/en not_active Withdrawn
- 1993-04-02 WO PCT/US1993/002813 patent/WO1993025262A1/en not_active Application Discontinuation
- 1993-04-02 CA CA 2137003 patent/CA2137003A1/en not_active Abandoned
- 1993-04-02 DE DE9390130U patent/DE9390130U1/en not_active Expired - Lifetime
- 1993-04-02 JP JP6501443A patent/JP2744911B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| WO1993025262A1 (en) | 1993-12-23 |
| DE9390130U1 (en) | 1995-02-02 |
| JPH07504592A (en) | 1995-05-25 |
| EP0680352A1 (en) | 1995-11-08 |
| JP2744911B2 (en) | 1998-04-28 |
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