CA2221847A1 - Implantable access device - Google Patents
Implantable access device Download PDFInfo
- Publication number
- CA2221847A1 CA2221847A1 CA002221847A CA2221847A CA2221847A1 CA 2221847 A1 CA2221847 A1 CA 2221847A1 CA 002221847 A CA002221847 A CA 002221847A CA 2221847 A CA2221847 A CA 2221847A CA 2221847 A1 CA2221847 A1 CA 2221847A1
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- Canada
- Prior art keywords
- wall
- reservoir
- chamber
- valve
- filament
- 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
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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
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
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- 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
- A61M2039/0241—Subcutaneous access sites for injecting or removing fluids having means for filtering
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
Abstract
A septumless implantable access device (10) suitable for delivering a liquid medication to a site remote from the site of device implantation is disclosed, which contains a filter assembly (20) for removing particulate material from fluid injected into the device. The filter assembly of the invention contains a first reservoir chamber (30) having cutouts, recesses, and/or sharp corners in which particulate material may be trapped, and additionally having a first wall (25) forming a filter barrier capable of 360· of fluid flow therethrough. The implantable access device may also include an infusion pump apparatus coupled to the access device.
Description
W o 96/40358 PCT~B96/00100 IMPLANTABLE ACCESS DEVICE
Backqround of the Invention The ~ sent invention relates to i,oplantable reservoirs for providing a treatment r~aterial~ such as a drug in fluid form, directly to an intemal site of a patient. More specifically, the invention relates to a septumless implantable 10 reservoir containing a filtering means to remove particulate matter and bacteria from fluid injected into the reservoir.
Implantable devices have been developed for infusion or delivery of medications into a specific body site, for example, to avoid repeated intravenous, intrathecal, or epidural injections and thereby to mi,)il),i,e discomfort to a patient.
1~ Such devices generally include a housing containing an intemal reservoir or chamber with an outlet cannula ~or connection to a catheter, and a penetrable resealable septum, all of which are biocompatible. The devices may be implanted subcutaneously, with the septum oriented just under the skin to provide easy access to repeated needle penetration. A catheter generally connects the outlet cannula of 20 the device to a site remote from the site of implantation. Medication may be iniected through the septum into the reservoir of the device, thus allowing delivery of the medication directly to the remote treatment site.
Some medical conditions require installation of a pump drug delivery device in the body of the patient which is capable of delivering medication into a remote 25 site through a catheter over a prolonged period of time. For example, chronic pain patients may receive such a pump for delivery of analgesics directly into the central nervous system via the spinal fluid. Such an access device may also be installed to replenish medication supply to a pump drug delivery device.
Conventional intraspinal access devices are generally similar to other 30 implantable treatment reservoirs for injecting drugs or withdrawing blood samples, such as central venous access devices. All of those devices inciude a biocompatible housing containing an internal chamber or reservoir in fluid communication with the treatment site, i.e., the vascular system, intrathecal space, or epidural space, through a catheter, and a septum capable of resealing after being 3~ punctured by a needle. The useful life o~ irnplantable treatment material devices which include a septum is limited by the number of punctures that the septum canwithstand before it leaks, because repeat access slowly degrades the silicone until CA 0222l847 l997-ll-l8 W O 96/40358 PcT/lL3c/~oloo ultimately it is unable to resist the passage of fluids or other elements that are in communication with the device. Moreover, expensive non-coring needles or filaments are preferably used to access the device, in order to reduce the damage to the septum. Such non-coring filaments are also preferably of small diameter or gauge, rendering septum-containing devices unsuitable for treatments which require high blood flows.
Intraspinal access devices of the prior art may develop blockages from particulate matter such as metal filings from needles and other metal present orfrom parts of the septum which may slough off as a result of needle puncture.
10 Presently available intraspinal access devices and systems include filters which may be between the syringe and the needle or in the device itself.
Several kinds of filters are currently available. One kind, for access devices having a generally cylindrical internal reservoir with the exit port extending from a point on the cylindrical side surface of the reservoir, comprises a cylindrical screen positioned in the reservoir and having a diameter substantially equal to the inner diameter of the reservoir. A second kind, for access devices having an exit portextending from a point on the bottom surface of the reservoir, includes a mesh screen positioned on the bottom surface of the reservoir. These kinds of i~,l,aspi~,al access device filters are not capable of screening out much particulate matter, because the mesh of such filters is necessarily large in order to accommodate a satisfactory flow rate. One problem with a finer mesh is that needles injected into the septum of the device would cause more significant damage to the screen. A
second problem is that the screens are placed directly adjacent to the outlet port, allowing only a small area of the screen to permit flow-through of fluid from the device, i.e., and that small area of flow-through is easily clogged. Also the fluid impedance is relatively high for small area filters.
U.S. Patent No. 5,137,529 discloses an injection device conWI,i"g a filter barrier extending across the internal injection chamber and separating the injection chamber into an upper portion adjacent to the septum and a lower portion in open30 fluid communication with the outlet conduit of the device.
U.S. Patent No. 5,185,003 discloses a device for injecting medicaments containing a circular cylindrical filter member having a conical inner wall and being exactly adapted to fit the diameter of the inner cavity of the port. Another W O 96/403~8 PCT~B96/00100 embodiment disclosed in U.S. Patent No. 5,185,003 includes a filter member in the form of a plane-parallel disc between the inner cavity of the port and the outlet opening to the catheter.
A need exists, therefore, for a septumless implantable treatment access 5 device capable of filtering particulate matter out of medication being delivered to a specific body site.
One object of the invention is to provide a septumless i~ ,lan~zk'~ treatment access device which is capable of removing debris from fluid injected therein.
Another object of the invention is to provide a septumless illll~spil,al access 10 device for intrathecal or epidural delivery of medications which are substantially free of particulate " ,ate, ial.
SummarY of the Invention The present invention provides a septumless multi-chambered i,~"~lan' ~'e device including an access device having improved filtering capabilities. The 15 il"planlable access device of the invention includes a biocompatible housing having at least one entry port and at least one aperture with a passageway extending therebetwe~en. The housing further includes a valve assembly disposed in the passageway, and the valve assembly includes a valve and a sealing element. In use, a filament, such as a needle, is introduced through the entry port, activating 20 (opening) the valve to allow access through the passageway. Independent of the activation cf the valve, a seal is created about the filament by the sealing element before the valve opens. The aperture communicates with an internal substantiallycylindrical reservoir in the housing, the reservoir being defined by a lateral surface extending about a central axis and a bottom surface. An outlet cannula defining an 25 internal channel extending from a point on the internal wall of the reservoir extends from the housing and is adapted to receive a catheter. A filter assembly is disposed in the reservoir.
The filter assembly of the invention includes a toroidal fluid permeable first wall, preferably a substantially cylindrical shell interior to and spaced apart from the 30 lateral surface of the reservoir. In one form, the diameter of the first wall is sufficiently smaller than the inner diameter of the reservoir to allow a full 360_ of fluid flow through the first wall, effectively utilizing substantially all of the surface area of the flrst wall as a filter barrier, in contrast to the limited surface area of W O 96/40358 PCT~B96/00100 known injection device filters. Placement of the first wall est~blishes two chambers:
a first annular chamber between the first wall and the lateral surface of the housing reservoir; and a first reservoir chamber interior to the first wall. The first annular chamber and the first reservoir chamber are in fluid communication only through the 5 filter assembly's first wall, and the outlet cannula channel is in direct fluid communication only with the first annular chamber. In some embodiments, the filter assembly of the invention comprises a one-stage filter; for example, a one-stagefilter is formed by filter assemblies having only a first wall. In other embodiments a substantially cylindrical, fluid permeable second wall may be provided to form a10 two-stage filter assembly, the second wall being placed interior to and spaced apart from the first filter assembly wall. The diameter of the second wall is sufficiently smaller than the diameter of the first wall to allow a full 360~ of fluid flow through the second wall, allowing substantially all of the surface area of the second wall to be useful as a filter barrier. In these embodiments, the second wall forms an 15 additional, second annular chamber within the first reservoir chamber.
In accordance with the present invention, fluid injected through the passageway into the filter assembly flows from the first reservoir chamber through the substantially cylindrical first wall, into the first annular chamber formed by the first wall of the filter assembly and the inner wall of the reservoir. Fluid then flows 20 from the first annular chamber to the outlet cannula to the treatment site. In those embodiments having a second wall and second annular chamber, injected fluid flows from the first reservoir chamber through the second wall into the second annular chamber, through the first wall to the first annular chamber and thence to the outlet cannula channel. In accordance with the present invention, fluid has no 25 direct access from the first reservoir chamber to the outlet cannula channel.The implantable device of the invention functions to filter debris out of fluid injected therein. The invention uses fluid dynamics created by the shape of the walls of the first reservoir chamber to trap particles in specifically designed cutouts, recesses, and/or sharp corners. When the device is ~ccessed by a filament and 30 fluid is injected into the filter assembly, a fluid flow is est~hlished in the first reservoir chamber which promotes accumulation of particulate matter from the fluid into the cutouts, recesses, and/or sharp corners. The cutouts, recesses, and/or sharp corners create static areas of fluid flow (dead space) or eddy flow paths in W O 96/40358 PCT~B96/00100 which particulate material accumulates. In accordance with the invention, the configuration of the cutouts, recesses, and/or sharp corners of the first reservoir chamber rnay be varied to oplil"i~e entrapment of particulate material. Thus using the implantable treatment material device of the invention, mainly particulate-free 5 material is delivered to the treatment site. The implantable device of the invention is especially suitable as an intraspinal access device for epidural or intrathecal administration of drugs.
In one embodiment, the invention provides an implantable access device comprising:
a biocor"pdliL le housing having at least one entry port and at least one aperture with a passageway extending therebetween, said entry port being adaptedto receive a filament for passage into said passageway, said housing further including and disposed in said passageway a valve assembly comprising a valve and a sealing element, said valve assembly adapted to be activated by said filament after passage of said filament through said entry port whereupon a seal, independent of activation of said valve, is created by said sealing element about said filament before said valve opens to allow access through said passageway, said aperture communicating with an internal suLsl~nlidlly cylindrical reservoir in the housing, said reservoir being defined by a lateral surface extending about a central axis and a bottom surface;
an outlet extending through said housing along an outlet channel axis from a point on said lateral surface of said reservoir; and a filter assembly disposed in said reservoir, said filter assembly including a substantially cylindrical fluid permeable first wall interior to and spaced apart from said lateral surface of said reservoir, said first wall establishing a first annular chamber between said first wall and said lateral surface and a first reservoir chamber interior to said first wall, said first annular chamber and said first reservoir chamber being in fluid communication only through said first wall, and said outlet being in direct fluid communication with said first annular chamber.
Brief DescriPtion of the Drawinqs The foregoing and other objects of this invention, the various features thereof, as well as the invention itself, may be more fully understood from the following description, when read together with the accompanying drawings in which:
WO 9~/4~3~8 PCT~B96/00100 Figure 1A shows in sectional schematic form, a septumless i~llplanlable two-stage filter access device of the invention with an intemal reservoir and filter assembly with a valve embodiment comprising an opening, in the closed configuration.
Figure 1B shows in sectionai schematic form, the device of Figure 1A in an open configuration.
Figure 2 shows in sectional schematic form, an implantable two-stage filter access device of the invention with an internal reservoir and filter assembly with a valve embodiment co",p~i~il,g a duck bill type valve in an open configuration.
Figure 3 shows a schematic representation, partly in section, of an infusion apparatus which incorporates two assemblies in accordance with the invention.
In the various figures, corresponding elements are denoted by the same reference designations.
Detailed Description of the Invention The device 10 of the present invention as depicted in Figures 1A, 1B, and 2, includes a biocompatible housing 2 having a radially extending base flange plate 7.
For ease of manufacture, housing 2 may be comprised of several parts, e.g., part 2', part 2", and part 2"'. The housing 2 includes an interior reservoir 9 principally disposed in part 2"' defined by lateral surface 5 and bottom surface 6. As shown, reservoir 9 is cylindrical (having diameter D), extending along central axis A, with a circular cross-section perpendicular to central axis A. In other embodiments, reservoir 9 may be "substantially cylindrical", including functionally equivalent geometries, such as having an elliptical or polygonal cross-section perpendicular to central axis A. Flange plate 7 may include a m~ 'y of apertures through which sutures may pass to anchor the device to the patient's muscle fascia. The parts 2' and 2" include a septumless access port and valve/seal assembly 3 which is coupled to an aperture 22'.
The reservoir 9 is in fluid communication with aperture 22' of the access port and valve/seal assembly 3. Part 2"' includes an outlet P from which an outlet 30 cannula 11 extends. In the illustrated embodiment, cannula 11 extends from part 2"' at a first end 11A (where it is integral with part 2"' at outlet P) to a second end 11B which receives a catheter 13.
CA 0222l847 l997-ll-l8 W O 96/40358 PCT~B96/00100 Figures 1A, 1B, and 2 show a two-stage filter assembly 20 installed within - reservoir 9. Also shown in the figures is the lateral surface 5 of the reservoir 9. As shown in the figures, filter assembly 20 comprises a fluid permeable first wall 25 (stage 1) and a fluid permeable second wall 27 (stage 2). First wall 25 is 5 substantially cylindrical and has a diameter Dw, which is less than D. That wall 25 is fluid permeable and is located interior to and spaced apart from the lateral surface 5 of reservoir 9 to allow a full 360~ of fluid flow through the first annular chamber 32 est~hlishecl between first wall 25 and lateral surface 5. First wall 25 also est~hlishes a first reservoir chamber 30 interior to first wall 25. In the embodiment 10 of Figures 1A, 1B, and 2, chamber 30 houses second wall 27 which divides thatchamber 30 to form second annular chamber 34 on one side of wall 27, with the remainder of chamber 30 on the other side of, and interior to, wall 27, as described in detail below.
The first annular chamber 32 and the first reservoir chamber 30 (as a whole) 15 are in fluid communication only through first wall 25. In accordance with theinvention, ~irst wall 25, as shown in Figures 1A, 1 B, and 2, functions to remove particulate material from fluid injected into first reservoir chamber 30 prior to entry of that fluid into chamber 32 and eventually into internal channel 12 within and defined by outlet cannula 11. Internal channel 12 extends from the first end 11A of outlet 20 cannula 11 along a channel axis CA from points on the lateral surface 5 of reservoir 9, to the second end 11B of outlet cannula 11. In accordance with the invention,channel 12 is in direct fluid commu~icalion only with first annular chamber 32.
The structure of first wall 25 may be selected to produce desired filtering capability. For example, first wall 25 may be formed from a mesh screen, the 25 porosity of which may also be varied to achieve desired filtering and fluid flow rates.
In the various forms of the invention different mesh sizes may be used, or alternatively, different forms of filter material may be used.
As shown in Figures 1A, 1B and 2, second wall 27 is also "substantially cylindrical" and fluid permeable, being placed interior to and spaced apart from first 30 wall 25, establishing a second annular chamber 34 within first reservoir chamber 30 and between first wall 25 and second wall 27. Second annular chamber 34 provides the only fluid flow paths between the first central portion (i.e., along central axis A) of reservoir chamber 30 and first annular chamber 32. Second wall 27 W O 96/40358 PCT~B96/00100 allows 360~ of fluid flow through that wall 27 to chamber 32. In accordance with the present invention, second wall 27 may take the form of a toroidal substrate extending about central axis A, and having a plurality of radially extending apertures 35 extending therethrough (and providing the fluid flow paths). The apertures 355 provide flltering, removing particulate material that is too large to pass therethrough.
The number and size of apertures 35 is selected to provide desired flltering and flow rates. In the embodiment of Figures 1A, 1B and 2, the substrate also supports first wall 25, which is affixed to that substrate.
In the embodiment of Figures 1A, 1B and 2, second wall 27 is shaped to 10 create an upper cylindrical reservoir sub-chamber 36a and a lower cylindricalreservoir sub-chamber 36b, respectively, within first reservoir chamber 30. The right-circular cylindrical geometry of those reservoir sub-chambers provides sharp right angle corners within flrst reservoir chamber 30. During the injection of fluid into the port through passageway 22', accumulation of particulate material or other 15 debris in those corners is promoted and, in some cases, particulate material and other debris is held in those corners by eddy currents.
Wlth particular reference to the access port and valve/seal assembly 3, parts 2' and 2" include an elongated open guidance channel 214 communicating with the entry port 216 of the housing. The guidance channel may be of a generally 20 V-shaped configuration, but other configurations such as U-shaped configurations are suitable. Housing 2 may contain a plurality of guidance channels. The open guidance channel allows for an increased strike area for guiding a fllament into the entry port of the device.
As shown in Figure 1B, device 10 may be accessed by inserting a filament 25 240, such as a cannulated needle, into elastomeric member or sealing element 220 positioned within a housing insert 230 which is disposed in passageway 222.
Housing insert 230 is employed for ease of manufacture, but it should be understood that it could also be integral in the geometry of housing 2. Elastomeric member 220, in this embodiment, includes a plug 226 and an opening 242, 30 terminating in a cap 224. Cap 224 may be titanium, stainless steel or any other suitable resilient metal. Elastomeric member 220 further has a transition region 232 along which the outer diameter of the elastomeric member 220 decreases from a first larger diameter to a second smaller diameter.
W O 96/403~8 PCT~B96/00100 Thle interaction between the elastomeric member 220, specifically its transition region 232, and the housing insert 230 will create a seal around an accessing filament. Elastomeric member 220 has a substantially thinner walled section 234 above transition region 232. Also within passageway 222 is a filament 5 retention piece 236. Valve means opening 242 in part 2" is in fluid communication with intemal reservoir 9 through aperture 22'. Plug 226 is located at the distal end of the elastomeric member 220 in a sealing engagement with passageway 222.
Figure 1A shows valve means opening 242 in a closed configuration, and Figure 1Bshows val~e means opening 242 in an open conflguration.
Typically the rilament 240 would be a needle but a catheter or other subslanlially rigid member could be used. Before movement of plug 226 out of passageway 222 and the opening of valve means opening 242 which would allow communication between filament 240 and aperture 22', a seal 233 is first createdabout filament 240. Seal 233 is maintained at all times when plug 226 and valve 15 means opening 242 allow communication between the filament 240 and aperture 22', and the seal is released only after plug 226 retums to a sealing engagementwithin passageway 222. Seal 233 is generated when the ll~nsilion region 232 of elastomeric member 220 is pulled into the smaller diameter of housing insert element 230, compressing the elastomeric member 220 against the accessing 20 filament 240. The fllament retention piece 236 is configured with an inner dimension smaller than the outer dimension of the accessing filament 240, such that as the accessing lilamenl 240 is introduced into the entry port of the device, the filament retention piece 236 expands and applies a force against the accessing rilal"enl 240 to resist its withdrawal from the entry port. Filament retention piece 25 236 may employ a strain release slot or slots 237 to tune the force applied to ~ccessing filament 240 and increase its useful life span.
Figure 2 depicts device 10' which includes another embodiment of the valve of the present invention. The valve of this embodiment is a duck bill or miter valve 246 in place of plug 226 and valve opening 242. Cap 248 has replaced cap 224 A
30 fastener 250 assists in maintaining the coupling between elastomeric member 220' and cap 248. Elastomeric member 220' has all of the attributes of elastomeric member 220. Housing insert 230' is substantially like housing insert 230, and the remaining structural elements of this valve means embodiment are similar to those CA 0222l847 l997-ll-l8 WO 96/40358 PCT/IB96/OOlO0 described in relation to Figures 1A and 1 B. Accessing filament 240 moves cap 248 and elastomeric element 220' to create a seal 233 about rilamenl 240 before valve 246 iS opened. As filament 240 advances, cap 248 moves to open valve 246 to est~hlish fluid communication between the filament and intemal reservoir 9. Seal233 iS maintained about the accessing filament during the time that the valve isopen, and seal 233 is not released until after the valve is closed. Figure 2 depicts the duck bill valve in its open configuration.
In other forms of the invention, one or more access devices of the type described above may aiso be functional components of an infusate pump apparatus 10 of the type disclosed in U.S. Patent No. 4,496,343. Tuming lastly to Fig. 3, there is shown a schematic view of the device of the present invention as an integral functioning part of an implantable medical apparatus or infusion pump 110. The infusion pump apparatus includes two access ports (a primary access port 158 anda secondary side access port 160) and a pump 166 all within a biocompatible 15 housing 170. The primary access port 158 is coupled to the input of pump 166 via cannula 11 and the output of pump 166 is coupled to the inlet port IP of side access port 160 via line 138. The pump is selectively operative to drive fluid at its input to exit its output. For example, any of the configurations described in Figs. 1A, 1B or 2 may be used for access ports 158 and 160, except that access port 160 has an 20 input port IP (in addition to its output port P) attached to the outlet tube 138 extending from pump 166. Although access port 160 is illustrated as being contained within a common housing 170, the present invention also encorrlpasses embodiments in which the infusate pump apparatus and the side access port 160 are connected but not contained within a common housing.
Those of skill in the art will recognize that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The presently described embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all variations 30 of the invention which are encompassed within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Backqround of the Invention The ~ sent invention relates to i,oplantable reservoirs for providing a treatment r~aterial~ such as a drug in fluid form, directly to an intemal site of a patient. More specifically, the invention relates to a septumless implantable 10 reservoir containing a filtering means to remove particulate matter and bacteria from fluid injected into the reservoir.
Implantable devices have been developed for infusion or delivery of medications into a specific body site, for example, to avoid repeated intravenous, intrathecal, or epidural injections and thereby to mi,)il),i,e discomfort to a patient.
1~ Such devices generally include a housing containing an intemal reservoir or chamber with an outlet cannula ~or connection to a catheter, and a penetrable resealable septum, all of which are biocompatible. The devices may be implanted subcutaneously, with the septum oriented just under the skin to provide easy access to repeated needle penetration. A catheter generally connects the outlet cannula of 20 the device to a site remote from the site of implantation. Medication may be iniected through the septum into the reservoir of the device, thus allowing delivery of the medication directly to the remote treatment site.
Some medical conditions require installation of a pump drug delivery device in the body of the patient which is capable of delivering medication into a remote 25 site through a catheter over a prolonged period of time. For example, chronic pain patients may receive such a pump for delivery of analgesics directly into the central nervous system via the spinal fluid. Such an access device may also be installed to replenish medication supply to a pump drug delivery device.
Conventional intraspinal access devices are generally similar to other 30 implantable treatment reservoirs for injecting drugs or withdrawing blood samples, such as central venous access devices. All of those devices inciude a biocompatible housing containing an internal chamber or reservoir in fluid communication with the treatment site, i.e., the vascular system, intrathecal space, or epidural space, through a catheter, and a septum capable of resealing after being 3~ punctured by a needle. The useful life o~ irnplantable treatment material devices which include a septum is limited by the number of punctures that the septum canwithstand before it leaks, because repeat access slowly degrades the silicone until CA 0222l847 l997-ll-l8 W O 96/40358 PcT/lL3c/~oloo ultimately it is unable to resist the passage of fluids or other elements that are in communication with the device. Moreover, expensive non-coring needles or filaments are preferably used to access the device, in order to reduce the damage to the septum. Such non-coring filaments are also preferably of small diameter or gauge, rendering septum-containing devices unsuitable for treatments which require high blood flows.
Intraspinal access devices of the prior art may develop blockages from particulate matter such as metal filings from needles and other metal present orfrom parts of the septum which may slough off as a result of needle puncture.
10 Presently available intraspinal access devices and systems include filters which may be between the syringe and the needle or in the device itself.
Several kinds of filters are currently available. One kind, for access devices having a generally cylindrical internal reservoir with the exit port extending from a point on the cylindrical side surface of the reservoir, comprises a cylindrical screen positioned in the reservoir and having a diameter substantially equal to the inner diameter of the reservoir. A second kind, for access devices having an exit portextending from a point on the bottom surface of the reservoir, includes a mesh screen positioned on the bottom surface of the reservoir. These kinds of i~,l,aspi~,al access device filters are not capable of screening out much particulate matter, because the mesh of such filters is necessarily large in order to accommodate a satisfactory flow rate. One problem with a finer mesh is that needles injected into the septum of the device would cause more significant damage to the screen. A
second problem is that the screens are placed directly adjacent to the outlet port, allowing only a small area of the screen to permit flow-through of fluid from the device, i.e., and that small area of flow-through is easily clogged. Also the fluid impedance is relatively high for small area filters.
U.S. Patent No. 5,137,529 discloses an injection device conWI,i"g a filter barrier extending across the internal injection chamber and separating the injection chamber into an upper portion adjacent to the septum and a lower portion in open30 fluid communication with the outlet conduit of the device.
U.S. Patent No. 5,185,003 discloses a device for injecting medicaments containing a circular cylindrical filter member having a conical inner wall and being exactly adapted to fit the diameter of the inner cavity of the port. Another W O 96/403~8 PCT~B96/00100 embodiment disclosed in U.S. Patent No. 5,185,003 includes a filter member in the form of a plane-parallel disc between the inner cavity of the port and the outlet opening to the catheter.
A need exists, therefore, for a septumless implantable treatment access 5 device capable of filtering particulate matter out of medication being delivered to a specific body site.
One object of the invention is to provide a septumless i~ ,lan~zk'~ treatment access device which is capable of removing debris from fluid injected therein.
Another object of the invention is to provide a septumless illll~spil,al access 10 device for intrathecal or epidural delivery of medications which are substantially free of particulate " ,ate, ial.
SummarY of the Invention The present invention provides a septumless multi-chambered i,~"~lan' ~'e device including an access device having improved filtering capabilities. The 15 il"planlable access device of the invention includes a biocompatible housing having at least one entry port and at least one aperture with a passageway extending therebetwe~en. The housing further includes a valve assembly disposed in the passageway, and the valve assembly includes a valve and a sealing element. In use, a filament, such as a needle, is introduced through the entry port, activating 20 (opening) the valve to allow access through the passageway. Independent of the activation cf the valve, a seal is created about the filament by the sealing element before the valve opens. The aperture communicates with an internal substantiallycylindrical reservoir in the housing, the reservoir being defined by a lateral surface extending about a central axis and a bottom surface. An outlet cannula defining an 25 internal channel extending from a point on the internal wall of the reservoir extends from the housing and is adapted to receive a catheter. A filter assembly is disposed in the reservoir.
The filter assembly of the invention includes a toroidal fluid permeable first wall, preferably a substantially cylindrical shell interior to and spaced apart from the 30 lateral surface of the reservoir. In one form, the diameter of the first wall is sufficiently smaller than the inner diameter of the reservoir to allow a full 360_ of fluid flow through the first wall, effectively utilizing substantially all of the surface area of the flrst wall as a filter barrier, in contrast to the limited surface area of W O 96/40358 PCT~B96/00100 known injection device filters. Placement of the first wall est~blishes two chambers:
a first annular chamber between the first wall and the lateral surface of the housing reservoir; and a first reservoir chamber interior to the first wall. The first annular chamber and the first reservoir chamber are in fluid communication only through the 5 filter assembly's first wall, and the outlet cannula channel is in direct fluid communication only with the first annular chamber. In some embodiments, the filter assembly of the invention comprises a one-stage filter; for example, a one-stagefilter is formed by filter assemblies having only a first wall. In other embodiments a substantially cylindrical, fluid permeable second wall may be provided to form a10 two-stage filter assembly, the second wall being placed interior to and spaced apart from the first filter assembly wall. The diameter of the second wall is sufficiently smaller than the diameter of the first wall to allow a full 360~ of fluid flow through the second wall, allowing substantially all of the surface area of the second wall to be useful as a filter barrier. In these embodiments, the second wall forms an 15 additional, second annular chamber within the first reservoir chamber.
In accordance with the present invention, fluid injected through the passageway into the filter assembly flows from the first reservoir chamber through the substantially cylindrical first wall, into the first annular chamber formed by the first wall of the filter assembly and the inner wall of the reservoir. Fluid then flows 20 from the first annular chamber to the outlet cannula to the treatment site. In those embodiments having a second wall and second annular chamber, injected fluid flows from the first reservoir chamber through the second wall into the second annular chamber, through the first wall to the first annular chamber and thence to the outlet cannula channel. In accordance with the present invention, fluid has no 25 direct access from the first reservoir chamber to the outlet cannula channel.The implantable device of the invention functions to filter debris out of fluid injected therein. The invention uses fluid dynamics created by the shape of the walls of the first reservoir chamber to trap particles in specifically designed cutouts, recesses, and/or sharp corners. When the device is ~ccessed by a filament and 30 fluid is injected into the filter assembly, a fluid flow is est~hlished in the first reservoir chamber which promotes accumulation of particulate matter from the fluid into the cutouts, recesses, and/or sharp corners. The cutouts, recesses, and/or sharp corners create static areas of fluid flow (dead space) or eddy flow paths in W O 96/40358 PCT~B96/00100 which particulate material accumulates. In accordance with the invention, the configuration of the cutouts, recesses, and/or sharp corners of the first reservoir chamber rnay be varied to oplil"i~e entrapment of particulate material. Thus using the implantable treatment material device of the invention, mainly particulate-free 5 material is delivered to the treatment site. The implantable device of the invention is especially suitable as an intraspinal access device for epidural or intrathecal administration of drugs.
In one embodiment, the invention provides an implantable access device comprising:
a biocor"pdliL le housing having at least one entry port and at least one aperture with a passageway extending therebetween, said entry port being adaptedto receive a filament for passage into said passageway, said housing further including and disposed in said passageway a valve assembly comprising a valve and a sealing element, said valve assembly adapted to be activated by said filament after passage of said filament through said entry port whereupon a seal, independent of activation of said valve, is created by said sealing element about said filament before said valve opens to allow access through said passageway, said aperture communicating with an internal suLsl~nlidlly cylindrical reservoir in the housing, said reservoir being defined by a lateral surface extending about a central axis and a bottom surface;
an outlet extending through said housing along an outlet channel axis from a point on said lateral surface of said reservoir; and a filter assembly disposed in said reservoir, said filter assembly including a substantially cylindrical fluid permeable first wall interior to and spaced apart from said lateral surface of said reservoir, said first wall establishing a first annular chamber between said first wall and said lateral surface and a first reservoir chamber interior to said first wall, said first annular chamber and said first reservoir chamber being in fluid communication only through said first wall, and said outlet being in direct fluid communication with said first annular chamber.
Brief DescriPtion of the Drawinqs The foregoing and other objects of this invention, the various features thereof, as well as the invention itself, may be more fully understood from the following description, when read together with the accompanying drawings in which:
WO 9~/4~3~8 PCT~B96/00100 Figure 1A shows in sectional schematic form, a septumless i~llplanlable two-stage filter access device of the invention with an intemal reservoir and filter assembly with a valve embodiment comprising an opening, in the closed configuration.
Figure 1B shows in sectionai schematic form, the device of Figure 1A in an open configuration.
Figure 2 shows in sectional schematic form, an implantable two-stage filter access device of the invention with an internal reservoir and filter assembly with a valve embodiment co",p~i~il,g a duck bill type valve in an open configuration.
Figure 3 shows a schematic representation, partly in section, of an infusion apparatus which incorporates two assemblies in accordance with the invention.
In the various figures, corresponding elements are denoted by the same reference designations.
Detailed Description of the Invention The device 10 of the present invention as depicted in Figures 1A, 1B, and 2, includes a biocompatible housing 2 having a radially extending base flange plate 7.
For ease of manufacture, housing 2 may be comprised of several parts, e.g., part 2', part 2", and part 2"'. The housing 2 includes an interior reservoir 9 principally disposed in part 2"' defined by lateral surface 5 and bottom surface 6. As shown, reservoir 9 is cylindrical (having diameter D), extending along central axis A, with a circular cross-section perpendicular to central axis A. In other embodiments, reservoir 9 may be "substantially cylindrical", including functionally equivalent geometries, such as having an elliptical or polygonal cross-section perpendicular to central axis A. Flange plate 7 may include a m~ 'y of apertures through which sutures may pass to anchor the device to the patient's muscle fascia. The parts 2' and 2" include a septumless access port and valve/seal assembly 3 which is coupled to an aperture 22'.
The reservoir 9 is in fluid communication with aperture 22' of the access port and valve/seal assembly 3. Part 2"' includes an outlet P from which an outlet 30 cannula 11 extends. In the illustrated embodiment, cannula 11 extends from part 2"' at a first end 11A (where it is integral with part 2"' at outlet P) to a second end 11B which receives a catheter 13.
CA 0222l847 l997-ll-l8 W O 96/40358 PCT~B96/00100 Figures 1A, 1B, and 2 show a two-stage filter assembly 20 installed within - reservoir 9. Also shown in the figures is the lateral surface 5 of the reservoir 9. As shown in the figures, filter assembly 20 comprises a fluid permeable first wall 25 (stage 1) and a fluid permeable second wall 27 (stage 2). First wall 25 is 5 substantially cylindrical and has a diameter Dw, which is less than D. That wall 25 is fluid permeable and is located interior to and spaced apart from the lateral surface 5 of reservoir 9 to allow a full 360~ of fluid flow through the first annular chamber 32 est~hlishecl between first wall 25 and lateral surface 5. First wall 25 also est~hlishes a first reservoir chamber 30 interior to first wall 25. In the embodiment 10 of Figures 1A, 1B, and 2, chamber 30 houses second wall 27 which divides thatchamber 30 to form second annular chamber 34 on one side of wall 27, with the remainder of chamber 30 on the other side of, and interior to, wall 27, as described in detail below.
The first annular chamber 32 and the first reservoir chamber 30 (as a whole) 15 are in fluid communication only through first wall 25. In accordance with theinvention, ~irst wall 25, as shown in Figures 1A, 1 B, and 2, functions to remove particulate material from fluid injected into first reservoir chamber 30 prior to entry of that fluid into chamber 32 and eventually into internal channel 12 within and defined by outlet cannula 11. Internal channel 12 extends from the first end 11A of outlet 20 cannula 11 along a channel axis CA from points on the lateral surface 5 of reservoir 9, to the second end 11B of outlet cannula 11. In accordance with the invention,channel 12 is in direct fluid commu~icalion only with first annular chamber 32.
The structure of first wall 25 may be selected to produce desired filtering capability. For example, first wall 25 may be formed from a mesh screen, the 25 porosity of which may also be varied to achieve desired filtering and fluid flow rates.
In the various forms of the invention different mesh sizes may be used, or alternatively, different forms of filter material may be used.
As shown in Figures 1A, 1B and 2, second wall 27 is also "substantially cylindrical" and fluid permeable, being placed interior to and spaced apart from first 30 wall 25, establishing a second annular chamber 34 within first reservoir chamber 30 and between first wall 25 and second wall 27. Second annular chamber 34 provides the only fluid flow paths between the first central portion (i.e., along central axis A) of reservoir chamber 30 and first annular chamber 32. Second wall 27 W O 96/40358 PCT~B96/00100 allows 360~ of fluid flow through that wall 27 to chamber 32. In accordance with the present invention, second wall 27 may take the form of a toroidal substrate extending about central axis A, and having a plurality of radially extending apertures 35 extending therethrough (and providing the fluid flow paths). The apertures 355 provide flltering, removing particulate material that is too large to pass therethrough.
The number and size of apertures 35 is selected to provide desired flltering and flow rates. In the embodiment of Figures 1A, 1B and 2, the substrate also supports first wall 25, which is affixed to that substrate.
In the embodiment of Figures 1A, 1B and 2, second wall 27 is shaped to 10 create an upper cylindrical reservoir sub-chamber 36a and a lower cylindricalreservoir sub-chamber 36b, respectively, within first reservoir chamber 30. The right-circular cylindrical geometry of those reservoir sub-chambers provides sharp right angle corners within flrst reservoir chamber 30. During the injection of fluid into the port through passageway 22', accumulation of particulate material or other 15 debris in those corners is promoted and, in some cases, particulate material and other debris is held in those corners by eddy currents.
Wlth particular reference to the access port and valve/seal assembly 3, parts 2' and 2" include an elongated open guidance channel 214 communicating with the entry port 216 of the housing. The guidance channel may be of a generally 20 V-shaped configuration, but other configurations such as U-shaped configurations are suitable. Housing 2 may contain a plurality of guidance channels. The open guidance channel allows for an increased strike area for guiding a fllament into the entry port of the device.
As shown in Figure 1B, device 10 may be accessed by inserting a filament 25 240, such as a cannulated needle, into elastomeric member or sealing element 220 positioned within a housing insert 230 which is disposed in passageway 222.
Housing insert 230 is employed for ease of manufacture, but it should be understood that it could also be integral in the geometry of housing 2. Elastomeric member 220, in this embodiment, includes a plug 226 and an opening 242, 30 terminating in a cap 224. Cap 224 may be titanium, stainless steel or any other suitable resilient metal. Elastomeric member 220 further has a transition region 232 along which the outer diameter of the elastomeric member 220 decreases from a first larger diameter to a second smaller diameter.
W O 96/403~8 PCT~B96/00100 Thle interaction between the elastomeric member 220, specifically its transition region 232, and the housing insert 230 will create a seal around an accessing filament. Elastomeric member 220 has a substantially thinner walled section 234 above transition region 232. Also within passageway 222 is a filament 5 retention piece 236. Valve means opening 242 in part 2" is in fluid communication with intemal reservoir 9 through aperture 22'. Plug 226 is located at the distal end of the elastomeric member 220 in a sealing engagement with passageway 222.
Figure 1A shows valve means opening 242 in a closed configuration, and Figure 1Bshows val~e means opening 242 in an open conflguration.
Typically the rilament 240 would be a needle but a catheter or other subslanlially rigid member could be used. Before movement of plug 226 out of passageway 222 and the opening of valve means opening 242 which would allow communication between filament 240 and aperture 22', a seal 233 is first createdabout filament 240. Seal 233 is maintained at all times when plug 226 and valve 15 means opening 242 allow communication between the filament 240 and aperture 22', and the seal is released only after plug 226 retums to a sealing engagementwithin passageway 222. Seal 233 is generated when the ll~nsilion region 232 of elastomeric member 220 is pulled into the smaller diameter of housing insert element 230, compressing the elastomeric member 220 against the accessing 20 filament 240. The fllament retention piece 236 is configured with an inner dimension smaller than the outer dimension of the accessing filament 240, such that as the accessing lilamenl 240 is introduced into the entry port of the device, the filament retention piece 236 expands and applies a force against the accessing rilal"enl 240 to resist its withdrawal from the entry port. Filament retention piece 25 236 may employ a strain release slot or slots 237 to tune the force applied to ~ccessing filament 240 and increase its useful life span.
Figure 2 depicts device 10' which includes another embodiment of the valve of the present invention. The valve of this embodiment is a duck bill or miter valve 246 in place of plug 226 and valve opening 242. Cap 248 has replaced cap 224 A
30 fastener 250 assists in maintaining the coupling between elastomeric member 220' and cap 248. Elastomeric member 220' has all of the attributes of elastomeric member 220. Housing insert 230' is substantially like housing insert 230, and the remaining structural elements of this valve means embodiment are similar to those CA 0222l847 l997-ll-l8 WO 96/40358 PCT/IB96/OOlO0 described in relation to Figures 1A and 1 B. Accessing filament 240 moves cap 248 and elastomeric element 220' to create a seal 233 about rilamenl 240 before valve 246 iS opened. As filament 240 advances, cap 248 moves to open valve 246 to est~hlish fluid communication between the filament and intemal reservoir 9. Seal233 iS maintained about the accessing filament during the time that the valve isopen, and seal 233 is not released until after the valve is closed. Figure 2 depicts the duck bill valve in its open configuration.
In other forms of the invention, one or more access devices of the type described above may aiso be functional components of an infusate pump apparatus 10 of the type disclosed in U.S. Patent No. 4,496,343. Tuming lastly to Fig. 3, there is shown a schematic view of the device of the present invention as an integral functioning part of an implantable medical apparatus or infusion pump 110. The infusion pump apparatus includes two access ports (a primary access port 158 anda secondary side access port 160) and a pump 166 all within a biocompatible 15 housing 170. The primary access port 158 is coupled to the input of pump 166 via cannula 11 and the output of pump 166 is coupled to the inlet port IP of side access port 160 via line 138. The pump is selectively operative to drive fluid at its input to exit its output. For example, any of the configurations described in Figs. 1A, 1B or 2 may be used for access ports 158 and 160, except that access port 160 has an 20 input port IP (in addition to its output port P) attached to the outlet tube 138 extending from pump 166. Although access port 160 is illustrated as being contained within a common housing 170, the present invention also encorrlpasses embodiments in which the infusate pump apparatus and the side access port 160 are connected but not contained within a common housing.
Those of skill in the art will recognize that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The presently described embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all variations 30 of the invention which are encompassed within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (18)
1. An implantable access device 10 comprising:
a biocompatible housing 2 having at least one entry port 216 and at least one aperture 22' with a passageway 222 extending therebetween, said entry port being adapted to receive a filament 240 for passage into said passageway, said housing further including and disposed in said passageway a valve assembly 3 comprising a valve 242 and a sealing element 220, said valve assembly adapted tobe activated by said filament after passage of said filament through said entry port whereupon a seal, independent of activation of said valve, is created by said sealing element about said filament before said valve opens to allow access through saidpassageway, said aperture communicating with an internal substantially cylindrical reservoir 9 in the housing, said reservoir being defined by a lateral surface 5 extending about a central axis A and a bottom surface 6;
an outlet P extending through said housing along an outlet channel axis CA
from a point on said lateral surface of said reservoir, and a filter assembly 20 disposed in said reservoir, said filter assembly including a substantially cylindrical fluid permeable first wall 25 interior to and spaced apart from said lateral surface of said reservoir, said first wall establishing a first annular chamber 32 between said first wall and said lateral surface and a first reservoir chamber 30 interior to said first wall, said first annular chamber and said first reservoir chamber being in fluid communication only through said first wall, and said outlet being in direct fluid communication with said first annular chamber.
a biocompatible housing 2 having at least one entry port 216 and at least one aperture 22' with a passageway 222 extending therebetween, said entry port being adapted to receive a filament 240 for passage into said passageway, said housing further including and disposed in said passageway a valve assembly 3 comprising a valve 242 and a sealing element 220, said valve assembly adapted tobe activated by said filament after passage of said filament through said entry port whereupon a seal, independent of activation of said valve, is created by said sealing element about said filament before said valve opens to allow access through saidpassageway, said aperture communicating with an internal substantially cylindrical reservoir 9 in the housing, said reservoir being defined by a lateral surface 5 extending about a central axis A and a bottom surface 6;
an outlet P extending through said housing along an outlet channel axis CA
from a point on said lateral surface of said reservoir, and a filter assembly 20 disposed in said reservoir, said filter assembly including a substantially cylindrical fluid permeable first wall 25 interior to and spaced apart from said lateral surface of said reservoir, said first wall establishing a first annular chamber 32 between said first wall and said lateral surface and a first reservoir chamber 30 interior to said first wall, said first annular chamber and said first reservoir chamber being in fluid communication only through said first wall, and said outlet being in direct fluid communication with said first annular chamber.
2. The device according to claim 1 further comprising a cannula 11 extending at a first end 11 A thereof from said outlet and having a second end 11 B thereof adapted to receive a catheter 13, said outlet cannula further defining an internal channel 12 extending from said first end, along said channel axis to said secondend.
3. The device according to claim 1, wherein said filter assembly further includes:
a substantially cylindrical fluid permeable second wall 27 interior to and spaced apart from said first wall, said second wall establishing within said first reservoir chamber:
a second annular chamber 34 between said second wall and said first wall;
and at least one reservoir sub-chamber 36a, 36b interior to said second wall;
said second annular chamber being in fluid communication with said reservoir sub-chamber only through said second wall and being in fluid communication with said first annular chamber only through said first wall.
a substantially cylindrical fluid permeable second wall 27 interior to and spaced apart from said first wall, said second wall establishing within said first reservoir chamber:
a second annular chamber 34 between said second wall and said first wall;
and at least one reservoir sub-chamber 36a, 36b interior to said second wall;
said second annular chamber being in fluid communication with said reservoir sub-chamber only through said second wall and being in fluid communication with said first annular chamber only through said first wall.
4. The device according to claim 3 wherein said filter assembly includes a substrate extending about said central axis, said substrate forming said second wall and supporting said first wall.
5. The device according to claim 4, wherein said substrate is a rigid material and said second wall is formed by said substrate, said second wall having a plurality of passages 35 extending therethrough.
6. The device according to claim 4, wherein said filter assembly further comprises a second reservoir sub-chamber 36a, 36b interior to said second wall and adjacent to the bottom surface of the reservoir.
7. The device according to claim 6, wherein said substrate is a rigid material and said second wall is formed by said substrate, said second substrate having aplurality of passages 35 extending radially therethrough.
8. The device according to claim 6, wherein said reservoir sub-chambers comprise one or more acute corners in their defining surfaces.
9. The device according to claim 3, wherein said reservoir sub-chamber is defined by surfaces that establish a principal fluid flow path extending in saidreservoir sub-chamber and through said second wall, and establish one or more eddy flow paths that are substantially within said reservoir sub-chamber.
10. The device according to claim 3, wherein said reservoir sub-chamber is substantially cylindrical.
11. The device according to claim 1 wherein said valve comprises a miter valve 246.
12. The device according to claim 1 wherein said valve comprises a plug 226 seated in sealing engagement within said passageway, said plug adapted to be opened by forcing said plug from said sealing engagement by movement of said filament through said passageway.
13. The device according to claim 1 wherein said valve comprises an opening 242 adapted to be opened by movement of said filament into said valve assembly.
14. The device according to claim 1 wherein said outlet is adapted to be connected to a catheter, a graft, or an implanted medical device.
15. The device according to claim 1 wherein said filament is a needle having a point and wherein said housing further includes means for guiding said needle into said entry port.
16. The device according to claim 1, further comprising an infusion pump apparatus 110, said infusion pump apparatus including an input, an output and a pump 166 for selectively driving fluid entering said input to exit said output, and coupling means for coupling at least one of said input and said output of said pump apparatus to said implantable access device.
17. The device according to claim 16, wherein said coupling means includes means for coupling said outlet port of said implantable access device to said input of said infusion pump apparatus.
18. The device according to claim 16, wherein said implantable access device and said infusion pump apparatus are contained within a common housing 170.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/475,773 | 1995-06-07 | ||
US08/475,773 US5702363A (en) | 1995-06-07 | 1995-06-07 | Septumless implantable treatment material device |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2221847A1 true CA2221847A1 (en) | 1996-12-19 |
Family
ID=23889074
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002221847A Abandoned CA2221847A1 (en) | 1995-06-07 | 1996-02-07 | Implantable access device |
Country Status (5)
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US (2) | US5702363A (en) |
EP (1) | EP0830172A1 (en) |
JP (1) | JPH10506563A (en) |
CA (1) | CA2221847A1 (en) |
WO (1) | WO1996040358A1 (en) |
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-
1995
- 1995-06-07 US US08/475,773 patent/US5702363A/en not_active Expired - Lifetime
-
1996
- 1996-02-07 WO PCT/IB1996/000100 patent/WO1996040358A1/en not_active Application Discontinuation
- 1996-02-07 JP JP9500249A patent/JPH10506563A/en active Pending
- 1996-02-07 EP EP96900693A patent/EP0830172A1/en not_active Ceased
- 1996-02-07 CA CA002221847A patent/CA2221847A1/en not_active Abandoned
-
1997
- 1997-06-03 US US08/868,389 patent/US5840063A/en not_active Expired - Lifetime
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US5840063A (en) | 1998-11-24 |
WO1996040358A1 (en) | 1996-12-19 |
US5702363A (en) | 1997-12-30 |
EP0830172A1 (en) | 1998-03-25 |
MX9709871A (en) | 1998-08-30 |
JPH10506563A (en) | 1998-06-30 |
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Legal Events
Date | Code | Title | Description |
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EEER | Examination request | ||
FZDE | Discontinued |