CA2053251C - Implantable infusion device - Google Patents

Abstract

An infusion port (10) for implantation adapted for providing repeated access to specific tissue within a patient and communicating with the tissue by an internal implanted catheter (52). The infusi on ports according to this invention incorporate an enlarged entrance orifice (13) with a funnel shaped internal cavity which narrow s down to a reduced diameter passageway (18). An articulating catheter valve (24) is provided within the passageway which norm ally prevents the flow of fluids through the valve but can be penetrated by an external introduced filament (32) such as a catheter . After implantation, an external filament (32) which is introduced into the port (10) is guided by the port internal cavity int o registry with the catheter valve (24). Continued feeding of the filament (32) causes the catheter to pass through the valve (24). Thereafter, when a catheter (32) is inserted, therapeutic agents infused within the patient, or body fluids can be withdrawn. Alternate embodiments disclose various valve concepts (56) and means for providing a change in direction of an introduced filament ins erted through the infusion device. Additional embodiments disclose the concepts of providing an antimicrobial fluid bath (98) within the device for prevention of infection and various approaches for securely connecting an internal catheter (52) to an infus ion port.

Description

Wo 91/12838 2 0 ~ ~ 2 5 1 Pcr/us91tol4l4 IMPLANTABLE INFUSION DEVICE
FIELD OF THE INVENTION
This invention relates to a device for introducing a flexible filament into a patient such as a catheter for infusing a therapeutic agent to a desired site within the patient 5 or withdrawing a fluid and more particularly, to such a device which is implanted such that no portion is transcutaneous. Its access portion is subcutaneous but designed so as to l~cillt~le repeated access by the percutaneous route.
BACKGROUND AND SUMMARY OF THE INVENTION
In current human and animal medical practice there are numerous instances 10 where therapeutic agents must be delivered to a specific organ or a tissue within the body. An example is the infusion of chemotherapy into a central vein on a recurring basis over a lengthy l,eal",er,l period for w.despread sites of malignant tumor.Without an infusion device for intravenous drug infusion multiple vein punctures over a lengthy period results in progressive ll,ro",bosis venous sclerosis and destruction 15 of small diameter peripheral vessels. In other cases it may be desirable to infuse chemotherapy to a localized malignant tumor site. It may be difficult or impossible to deliver an agent specirically to such a site on a regular repetitive basis without surgically i",planling an infusion system. Similarly, repealed arterial access is occ~sionally needed for i",e ;on of an X-ray dye or cont,asl agent into an artery for 20 diagnostic purposes. In other situAtions~ there is a need to remove a body fluid repetitively for analysis from a remote body site. Finally sensing and physiological measuring devices i"cGr~.oraléd into small clia",eler catheters and small diameter optical fibers are increasi"gly being utilized for ",onitoring body processes and could be more easily implemented through a properly des;g,)ed access device with an 25 ~de~uete internal dia",eter.
In prior medical ,cractice, percutaneous cdtlletela have been used to provide vascular or organ access for drug therapy or removing body fluids. Although suchsystems generally pe,fo""ed in a sA~ ory manner numerous problems were preser,led by such therapy approaches, including the su6slanlial care requirements 30 by palier,lY, e.g. d,essil-y changes with sterile techniques a siguiricant rate of infection of the cdtl,eter bec~use of its transcutaneous position, and a high rate of venous ll,r~,"lbos;s, particularly if the catheter was located within an e,~t,e",ily vein.
bnplanlable infusion devices or"ports~ have recently beco",e available and are a siy"ificanl advance over transcutaneous c~ll,eterâ. Presently available infusion SUBSTITUTE SHEE I

WO 91/12838 ~ O S 3 2 51 PCI/US91/01414 ports have a number of cG""~)on h",da",ental design features. The ports themselves co",prise a housing which forms a reservoir whlch can be constructed from a variety of plastic or metal ",dlerials. A- surface of the reservoir is enclosed by a high-density, self-sealing septum, typically made of silicone rubber. Connected to the port 5 housing is an outflow cdtl.eter which communicates with a vein or other site within the patient where it is desired to infuse II,erapeutic agents. Implantation of such devices generally proceeds by making a small subcutAneous pocket in the patient under local anesll,esia. The internal out:flow c~tl,eter is tunnelled to the desired infusion site. When the physician desires to infuse or remove material through the 10 port, a hypodermic needle is used which pierces the skin over the infusion port and is placed into the port.
Although preser,lly available i")pla"table infusion ports generally operate in as~tisf~ctory manner, they have a number of sho,lcomings. Since these devices rely on a cGI"pressed rubber septum for sealing, there are limitations in the diameter of 15 needles which can be used to penetrate the septum, since large diameter needles can.seriously damage the septum. These cJia"~eter lil"it~lions severely restrict the flow rate of fluids passing through the port. In cases where it is desirable to infuse drugs using a flexible external inflow catheter, the cdtl,eler must be fed through the needle which penetrates the septum. Such callletets have an e)tt,emely small inside 20 dial"eter and, ll,ert~f~,re, impose severe limita~ions on fluid flow rate.
For prolonged infusion using a conventional port, the infusion needle is taped to the palienls skin to hold it in position. Conventional ports do not allow the needle to penel,a~e deeply into the port so that a small d;spl?ce"~en~ of the needle can cause it to be pulled from the port. In cases where locally toxic materials are being 25 infused, extrav~salion of such materials can cause local tissue damage which can lead to a requirement for cor,t~ /e surgery such as skin grafting or removal of tissue.
r,eser,lly available i",plantable drug infusion devices must also have a s;gni~icant size to provide an ~ccepts'~le target surface area for the physician who 30 must locate the port and penet,a~e the septum properly with a needle. The port housing beco",es bulky as the septum size i"c,eases since structure is required to maintain the septum in cG",~ression to provide self-sealing after the needle is removed. Moreover, preserilly available infusion ports are difficult to clear iflhro"lbosis occurs within them or in the i",planted outflow catheter, since it is difficult SUBSTITUTE SHEEl ~ ~3 ~
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if not impossible to feed a cleaning wire through the penetrating hypodermic needle in a manner which will clear the infusion device and the internal outflow catheter. Present infusion ports have a retained volume beneath the self-sealing septum which increases the volume of drug which must be administered to enable a desired quantity to reach the infusion site. This retained volume also poses problems when a physician desired to deliver drugs to the same infusion site which are incompatible when mixed. In addition, when it is desired to withdraw blood through the port, the retained volume of the prior art infusion ports comprises an area where blood clotting can occur, thus interfering with future access to the site. And finally, for present infusion ports, there is a risk that the physician attempting to pierce the port septum will not properly enter it, leading to the possibility of extravasation which can cause significant undesirable consequences.
In accordance with the present invention there is provided an implantable patient infusion device for permitting access to an internal catheter by a filament including an external catheter, wire or optical fiber comprising a housing having a funnel shaped entrance orifice having a decreasing cross sectional area which leads to a focus area, said housing further having a passageway communicating said focus area with an exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to said focus area and enter said passageway, an articulating catheter valve positioned within said housing passageway which normally ~,, .

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remains closed to provide resistance to flow of fluids through said valve, yet opens to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter, and means for mounting said infusion device subcutaneously.
In accordance with the present invention there is also provided an implantable patient infusion device and catheter combination comprising a housing having a funnel shaped entrance orifice having a decreasing cross-sectional area which leads to a focus area, said housing further having a passageway communicating said focus area with an exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to said focus area and enter said passageway, an articulating catheter valve positioned within said housing passageway which normally remains closed to provide resistance to flow of fluids through said valve, yet opens to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter, means for mounting said infusion device subcutaneously, and an external catheter with a hollow core having an access needle inserted thereinto, said valve allowing said external catheter and said needle to be inserted into said device and thereafter allowing said needle to be removed leaving said external catheter inside said device.
In accordance with the present invention there is also provided an implantable patient infusion device for permitting access to an internal catheter by a filament including an external catheter, wire or optical fiber, 3a comprising a housing defining an entrance orifice and an exit orifice with a passageway extending therebetween, said entrance orifice having a cross-sectional open area which decreases to a focus area communicating with said entrance orifice and said passageway, causing said filament introduced into said entrance orifice to be directed to enter said passageway once inserted through said entrance orifice and undergo a bend as it passes through said device, valve means which normally provides resistance to the flow of fluid through said infusion device but which is penetratable by said filament to permit said filament to pass into and through said housing passageway and means for mounting said infusion device subcutaneously.
The present invention relates to a family of implantable infusion ports which provide numerous enhancements over prior art devices. In accordance with this invention, an infusion port is provided which incorporates the funnel-shaped entrance orifice which narrows down to a reduced diameter guide passageway. The guide passageway terminates at an internal cavity which retains an articulating catheter valve such as a multi-element leaflet valve assembly. The port also has an exit passageway which is connected to an implantable outflow catheter.
Several embodiments of this invention are intended to be used by inserting a blunt instrument through the skin and into the port entrance orifice which introduces a filament such as a catheter into the port. The infusion port in accordance with other embodiments of the present invention are 3b C

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adapted to be used in conjunction with a sharp hypodermic access needle of conventional design which may be used by itself for lnfusion or fluid withdrawal, or with an external inflow catheter having the needle fed through it (or vice versa) allowing a catheter to be put in position within the infusion port or fed into the implantable catheter for infusion or withdrawal of fluid. The entrance orifice has a metal surface which guides the needle to the guide passageway.
The reduced diameter guide passageway of the port housing can be used to accurately align the access needle and/or catheter to strike the catheter valve at a desired area so that a needle can be used to penetrate the catheter valve repeatedly without impairing the function of the valve.
According to another group of embodiments of this invention, additional features of fusion ports are described.
One area of potential improvement for some 3c ~, .

2 0 ~ 3 2 51 PCr/US91/01414 - 4 - .
purposes is the provision of a port designed for i",planl~lion in a patient's arm which has an access pe~s~geway for an illselled needle. The body of this port is angled upwardly slightly to facilitate access. Such an angled infusion port can also feature modificetiQns to the ent,ance orifice to again further enhance the ability to access the 5 i" ,pla, Ited port. This _F,~ on further des~;, iL,es a valving coocept tor an implanted port which provides a high degree of resislance to body fluid leakage through the port and further provides a relatively low level of friction upon insertion of an e cte",al cdtl,eter with a relatively higher degree of friction upon v:;ll,.lra.lval of the catheter.
This di~ference in ,e~;stance aids both in b~se,lion of the cdtl,eter and in maintaining 10 the catheter in an i"se,led coridition within the i",planted port.
This specific~tion also descril~es port design features which are best embodied in a port in which the ent,dnce funnel is in a plane generally parallel to the mounting base of the port (i.e. the ~ccessi"g needle ~er,etlales per~,endicular to the mounting base). One improvement for such ports is the provision of a physical feature such 15 as a projecting lug, flange or other protuberance which enables the cl;nician to determine the orientdlion of the i",planted port through tactile ex~r"inalion. By knowing the port orienlalion the needle and introduced filament can o~ten be more readily inse,led into the port. This series of ports also known as ~chest wall~ ports (named for a pre~er,ad usage) also feature a funnel-shaped entrance orifice having 20 a prog,essively changing included angle. The orifice starts at its outer periphery with a relatively shallow included angle wh~ch Increases toward its center. This progressive change in cone angle provides two s;g"iflcanl benefits. First it results in a port which has a relatively shallow funnel which reduces the distance bet~ecn the skin surface and the ~tl,eler valve which seals around the introduced catheter 2~ or the ~ila",ent and also serves to better orient and hold the introducing needle.
Several of the ports according to this specification also feature means for stopping the introduced needle before reaching the c~tl,etar valve but permit the introduced catheter to pass through the cdtl,eler valve.
The infusion ports of this invention are i,nplanled in the same general manner 30 as prior art devices. When the physician desires to infuse a ll,e(apeutic agent remove a body fluid or have vascular access a fla",ent such as a catheter is introduced into the port. The erlt,ance orifice guides the introduced catheter or needle into a proper ~dc~c~illg" position with the articulating catheter valve. By pushing on the externally introduced filament, it is forced through the cdtl ,eter valve bO . , ;~ ~ , , , SUBSTITUTE SHE~1 WO 91/12838 2 ~ ~ 3 i? ~ I PCr/US91/01414 thereby providing an open communication palh-~ay for the infusion of therapeuticagents e,ntaction of body fluids, introduction of an optical fiber, clearing by a wire etc. The introduced lila",er,l can be fed into the oufflow catheter to any extend desired. In the case of introducing a flexible ~tl,a~er, a guide wire can be inserted 5 into the external cdl~,eter to i"c,ease its rlgidity. The convenient access to the port and internal oufflow catheter en?~'ss these ~'e.nenls to be cleared with a clearing wire so that they can always be cleared, avoiding the problem of permanent impaction of prior art devices. In addition, the ability to feed a guide wire into the infusion port and internal cdlheter of this invention en~les the internal catheter to 10 be repositioned using a bent or "steerable" guide wire.
The infusion ports having an articulating catheter valve of this invention possess the advantage that they have a very small reservoir or "dead space"
meaning that virtually all of the infused fluid is throughput to the desired infusion site.
This invention, therefore, f~ it~tes infusion of incG",pz"~'~ ",alerials in a serial 15 fashion since very little of the previously infused fluid remains in the device when a subsequent infusion is carried out. This invention also facilitates simultaneousinfusion of inco",palible .,-alerials by using a multi-lumen catheter.
Another aspect of the pres6nl invention is a design for an infusion port which is configured such that a line normal to the plane formed by the entrance orifice is 20 nearly at a right angle to the exit pAssAge~ay. The port access opening guides an introduced filament toward and into the oufflow catheter. This approach of guiding a ccll~,e~er to undergo a bend through the port can be used with conventional port designs having a self-sealing rubber septum. Other espect~ of the present invention relate to providing a reservoir within an infusion port for containing an ar,li"~-~robial 25 fluid, offering enhanced prutaction against introduced i"lection. This invention is further related to various means of securely fastening an oufflow catheter to aninfusion port.
Addi~ional bent~ and advantages of the presenl invention will become apparenl to those skilled in the art to wh~ch this invention relates from the 30 subse~uent descfipliol1 of the plefer,e~ embodiments and the appended claims taken in conjunction with the acco,npan~ing drawings.

SU~STITUTE S~F~l WO 91/12838 2 Q 5 3 2 ~ ~ PCI/US91/01414 BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a cross-sectional view of an infusion port in accordance with a first embodiment of the present invention shown with an ext~ al catheter and obturatorinserted though a leaflet type catheter valve.
Figure 2 is a p~- t~rial view of a skin punch which may be used to make an incision into a patients skin to permit Inse,lion of an e~ler"al catheter.
Figure 3 is an illu-~l,ation of a stab wound formed by the skin punch shown in Figure 2.
Figure 4 is a pictorial view of the leaflet valve used with the infusion port of10 Figure 1.
Figure 5 is a frontal view of a cup type catheter valve which is an alternate e",bodlment of an articulating catheter valve.
Figure 6 is a cross-sectional view of the valve of Figure 5 shown in a closed position.
15 Figure 7 is a cross-se~tional view from Figure 5 showing the catheter valve in a partly open posilion.
Figure 8 is a sectional view taken from Figure 5 showing the catheter valve in a fully open position per",illi"g p~ss~ge of an introduced catheter.
Figure 9 is a frontal view of a cdtl,eter valve of the ball-and-seat variety which 20 is an aller,)dle embodiment of an articulating catheter type valve.
Figure 10 is a cross-sectional view from Figure 9 showing the ball catheter valve in a fully closed condition.
Figure 11 is a cross-se~1ional view taken from Figure 9 shoJ~;ny the ball catheter valve in a fully opened cor,dition.
25 Figure 12 is a cross-sectional of an embodiment of this invention similar to Figure 1, illu~l,aling that an oxter.,al introduced cdll,eter may be placed well into the internal outflow cdtheter of the infusion port.
Figure 13 is a cross-sectional view similar to Figure 12 except showing th introduced ~tl,eler being fed through the infusion port such that its terminal end is 30 beyond the terminal end of the internal outflow cdtl,eter.
Figure 14 is a pictorial view of an infusion port in accorclance with a second embodiment of this invention shown providing a change in angle for the exterrlalintroduced catheter.

SUBSTITUTE SHEEl wO 91/12838 2 ~ ~ 3 2 5 1 Pcr/us9l/ol4l4 Figure 15 is a cross-se~tional view taken to the infusion port of Figure 14 showing the infusion port in use and sho~:;.,g an external introduced catheter in position tor infusion of the patient.
Figure 16 is a partial cross-sectional view of an infusion port in accordance with 5 a third embodiment of this invention shown employing a pair of separated leaflet valves which provided a reservoir for an antimicrobial fluid which provides enhanced resistance against infe-1ion.
Figure 17 is a cross-se tional view of an infusion port in accGrdance with a fourth embodiment of this invention employing a con~ ntional rubber septum but 10 having means for guiding a cdtl,eler or guide wire through a bend and into or beyond the port exit orifice.
~ igure 18 is an infusion port in accGr.lance with a flfth embodiment of this invention having an elliptically shaped ent,dnce mouth.
Figure 19 is a side view of the infusion port shown in Figure 18.
Figure 20 is a cross-sectional view illusl,dling a manner of connecting an internal oufflow cc.ll,eler to an infusion port in accordance with this invention, iocGr~Jorali"g an annular chamber for feCei-.ri,l9 the outflow cd~l,eler.
Figure 21 is a cross-sectional view of another means of attaching an internal oufflow cdll,eter to an infusion port according to this invention in which the catheter 20 is placed over a smooth cylindrical surface and a co",pression ring is slid onto the junction.
Figure 22 is a cross-sectional view of still another approach toward connecting an internal oufflow cdtl,eter to an infusion port incorporating a barbed nipple on the infusion port and a cG""~ression ring.
Figure 23 is an~tl,er means for attaching an internal oufflow catheter to an infusion port according to this invention i"cor~oralil)g an interlocking compression ring.
Figure 24 is a pictorial view of an infusion port in accor~Jdnce with a sixth embodiment of this invention shown atlacl,ecl to a internal catheter.
Figure 25 illustrates an access needle with an external catheter being used to penetrate the infusion port shown in Figure 24.
Figure 26 is an exploded pictorial view of the infusion port of this invention illustrated in Figure 25 shown with an optional elastic ring sealing disc for use with the leaflet valve elements.

SUBSTITUTE Sl~

WO 91/12838 2 0 S 3 2 ~ 1 PCrtUS91/01414 Figure 27 is a cross-sectional view taken from Figure 24 showing the internal construction of the infusion port according to this invention.
Figure 28 is a frontal view of the elastic leaflet valve elements as shown in Figures 26 and 27.
Figure 29 is a pictorial view of an angled infusion port according to a seventh embodiment of this invention.
Figure 30 is a side view of the port shown in Figure 29 shown i"~planted within a patient and being Accessed by a pen~balin~ needle.
Figure 31 is a pictorial view of an eighth embodiment of an infusion port 10 according to this invention.
Figure 32 is a cross-sectional view taken along line 32-32 from Figure 30.
Figure 33 is an exploded pictorial view of the catheter valve of the port shown in Figures 31 and 32.
Figure 34 is an enlarged cross-sectional view similar to Figure 32 but showing 15 an aGcessi"g needle being introduced into the port.
Figure 35 is a partial cross-sectional view showing the ~ccessil~g needle and call,eter being more fully inse,led into the port.
Figure 36 is a partial cross-sectional view sho~:; ,g the introduced catheter penel,aling the valve asse,.,bly of the port.
~igure 37 is a partial pictorial view showing an introduced catheter completely passing through the articulating valve and in a a proper docking position with the port for material infusion.
Figure 38 is an exploded pictorial view of another embodiment of an articulatingcall,eter valve accorcl;"g to this invention.
Figure 39 is an exploded pictorial view of another alternate embodiment of an articulating oatl,eter valve according to this invention.
DETAILED DESCRIPTION OF THE I~Ht~tHHtL~ EMBODIMENTS
An infusion port in accorc~ance with a first embodiment of this invention is shown in figure 1 and is generally .lesigr,aled there by reference number 10.
Infusion port 10 generally co",prises housing 12 defining an entrance orifice 14 an inside cavity 13 which funnels down to base 20, with an exit orifice 16, and an e'ongated passayeway 18 extending ~etv~an the e~l~"~al orifice base, and exit orifice 16. In the embodiment shown, infus~on port housing 12 is rotationally sy"~,net,ical about a central longitudinal axis passing through p~Csageway 18. As SUBSTITlJTE SI IEE-wO 91/12838 2 ~ 5 3 2 ~1 PCr/US91/01414 is evident from Figure 1, the diameter of er,l,ance orifice 14 is preferably several times greater than the internal c~lia",ater of p~Csageway 18 (i.e. an area difference four times or more). The entire housing 12 can be formed in one piece from numerous polymeric "~dlerials or metals which are cG,n~a~ le with human or animal 5 implantation.
Positioned within pAss~ge/;ay 18 is leaflet valve assel"bly 24, which is also shown in an exploded fashion in Figure 4. Leaflet valve assembly 24 is con,l~rised of one or more thin elastic disks 26 made, for G.~alll~le, from silicone rubber having one or more radial slits 28 cut through them. In the embodiment shown in Figures10 1 and 4, two disk 26 are provided, each having two slits with a right angle between them so that each defines four leaves 30. The disks 26 are oriented and stacked against one anotl,er so that slits 28 of both the disks are angularly misaligned. This misalignment is i"lenlionally provided to enhance the sealing characteristics of valve asse" ,~1y 24 when it is in its normal closed position, as shown in Figure 4.
15 Numerous other configurations for valve disk 26 can be provided, such as those incGrporali"g any number of adclitional slits having various numbers of leaves.
The embodiment of infusion port 10 shown in Figure 1 includes an optional thin rubber septum 31 which acts to shield erlt,dnce orifice 14. When a foreign object is i",p!a"led in a human, the body often develops fibrous tissue around the object.
20 If an exposed concave pocket is present, such as an open entrance orifice 14, the pocket could possil~ly become filled with such fibrous tissue. The development of this tissue, should such occur in a patient, might restrict access into the port, and potentially could interfere with the ~tl,eter valve function. Therefore, septum 31 provided which is pre-slit at 34 to allow the introduced external filament to easily 25 penetrate the septum. Septum 31 does not, ho~_~,cr, provide a fluid-tight barrier as in prior art infusion port which have self-sealing cl)aracterislics and is easily penet(ated by a blunt Instrument. The provision of septum 31 prevents tissue growth inside the housing cavity and also enables the region of housing between entrance orifice 14 and leaflet valve asse",bly 24 to act as a reservoir for the retention of an 30 antimicrobial fluid which aids in preventing the invasion of infectious agents during the use of infusion port 10.
In use, infusion port 10 is surgically positioned subcutaneously within the patient and mounted to suitable support Ussue using con~,entional mounting techniques, such as sutures or surgical staples. Internal outflow ~tl,eler 52 is tunneled to the SUBSTITUT~ SHE~:l 2 ~ ~ ~ 2 ~ ~
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desired site in the body. When access is desired for the in-fusion of therapeutic agents, for the sampling of body fluids or for the introduction of physiological sensing elements (electrical or optical transducers, etc.), a flexible external catheter 32 (or other filament) is introduced into infusion port 10, as shown in Figure 1. Insertion of external catheter 32 can be facilitated using skin punch 36 as shown in Figure 2. Skin punch 36 includes a pointed flat blade 38 having a width sufficient to make a desired length of an incision 40 shown in Figure 3. Skin punch 36 includes a radially exten-ding flange 42 which limits the depth of the incision 40. Tab 44 provides a convenient means for holding and using skin punch 36. Once external catheter 32 is introduced through stab wound 40, it passes into entrance orifice 14 and is guided by the funnel shaped configuration of the housing cavity into orientation with leaflet valve assembly 24.
Continued insertion of external catheter 32 causes the ex-ternal catheter to penetrate leaflet valve assembly 24, causing deflection of valve leaves 30.
In cases where external catheters 32 are used which are quite flexible, it is necessary to provide localized stif-fening of the introduced catheter to facilitate its introduc-tion through the stab wound and into the proper docking position with leaflet valve assembly 24. For such cases, a semi-rigid guide wire or obturator 46 having a blunt end 48 can be used which is inserted through the internal passageway - 50 of catheter 32.

Leaflet valve assembly 24 is relatively insensitive to the use of various diameters of external catheter 32, thus providing flexibility for the physician. Furthermore, the characteristics of leaflet valve assembly 24 are such that once external catheter 32 is inserted through the valve, the valve does not exert a large radially inward compressive force on the catheter, thus preventing collapsing of the catheter which would seal off internal passageway 50. However, it does provide sufficient friction on the external catheter to stabilize its position.
Figure 5 illustrates a cup-type catheter valve gen-erally designated by reference number 56. Valve 56 is another articulating type valve which can be used as a replacement for leaflet valve assembly 24 shown in Figure 1. For this embodi-ment a valve passageway 58 is formed which has a generally conically shaped exit nipple 60. A cup shaped closure valve 62 is provided which is supported in cantilever fashion by arm 64 which normally biases the cup closure valve into sealing engagement with exit nipple 60, as shown in Figure 6. Figure 7 illustrates catheter valve 56 when external catheter 32, reinforced with obturator 46 is initially penetrating valve passageway 58. During this process, external catheter 32 pushes cup closure valve 62 out of sealing engagement with valve nipple 60. Figure 8 illustrates the orientation of the elements of cup catheter valve 56 once external catheter 32 is fully introduced into the infusion port.
Figure 9 illustrates another embodiment for an articulating catheter valve in the form of a ball-and-seat 2 ~ ~ 3 ~ 5 ~
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valve, generally designated by reference number 68. Ball-and-seat valve 68 defines a conical ball seat 70 with ball closure valve 72 which is normally biased into sealing engagement with the ball seat by arm 74. Operation of ball-and-seat valve 68 is similar to the operation of cup catheter valve 56 pre-viously described. In both cases, external catheter 32 (or another filament), which may be stiffened by an obturator 46, physically unseats the valve element to permit passage of the external catheter.
Although the leaflet, cup, and ball-in-socket cath-eter valves described previously differ in their construction, each can be described as an "articulating" valve in that the introduced filament is accurately guided into an insertion area for the valve and deflects the valve in a predictable and repeatable manner to permit passage of a catheter or other filament. These valve types are distinguishable over prior art septums which are penetrated at random locations and do not define a predictable and defined passageway for a pene-trating needle which cuts through and physically damages the septum. Applicants submit that there are numerous additional articulating valve designs which achieve these desired char-acteristics and are fully applicable to the infusion ports of the present invention.
Figure 12 illustrates infusion port 10 described previously and shows that once external catheter 32 penetrates leaflet valve assembly 24 (or any other type of articulating valve used), the external catheter can be positioned at any desired point along internal outflow catheter 52. Figure 13 lla 62406-121 B

is a view similar to Figure 12 but shows the external catheter 32 can be fed through infusion port 10 so that its terminal end extends beyond that of internal catheter 52. This feature allows infusion port 10 to be readily adapted for angiography and angioplasty procedures.
Now with reference to Figures 14 and 15, a second embodiment of an infusion port according to this invention is shown which is generally designated by reference number 80.
Infusion port 80 differs principally from infusion port 10 in that the internal cavity 81 of housing 82 is in the shape of a bent or twisted funnel or horn llb 62406-121 , ,~

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such that a line normal to the plane defined by ent,ance orifice 84iS generally at a right angle to the longitudinal central axis of exit peSSA.~~e~ay 86. Like the first embodiment, infusion port 80 employs an articulating catl ,eter valve such as a leaflet vaive ~ss6l..bly 24 as previously descfiLed.
Infusion port cavity 81 has a smooth inside surface which is shaped to have a decreasi"g cross se~1ional area from e,-l,ance orifice 84 to exit passAgeway 86 for guiding exter"al catheter 32 into registry with the exit pAssagcway. The configuration of infusion port 80is desirable where a large target area is needed which is generally parallel to the surface of the palients skin overlying the device. In all other respectX
10 infusion port 60 is constru~ted and used in the manner consislent with that of intusion port 10 previously described. Figure 15 provides an illustration of infusion port 80 in use for infusing a patient. Port 80is shown faslened to support tissue 88 by sutures 90 below skin 92 of the patient.
Figure 16 is a partial se~iGnal view of an infusion port 94 according to a third15 embodiment of this invention. This embodiment differs from those described previously in that a pair of leaflet valve asse,r,~ es 24 is provided along internal passeseway 18 to define an enclosed internal cavity 98. Internal cavity 98 is provided so that an antimTcrobial solution 102 can be retained as a means of Inhibiting the introduction of ;n~ ;QUS agents into the patient through the process of infusion.
Figure 17 illustrates an infusion port in accordance with a fourth embodiment of this invention which is desig"aled by r~ ~rence number 106. Like the second embodiment shown in Figure 14, infusion port housing 108 has an internal cavity 109 which causes an ~,.te",al cdtl,t~ter or other filament to ~",de~yo a right angle bend 25 as it is fed into the device. However, infusion port 106 does not incG",o,ale an articulating cdtl,-~ter valve, but rather uses the con\e,ltional approach of using a co",pressed rubber septum 110. In use of this embodiment, a h~",oder"lic needle 112 penetrates septum 110 and a small d;ameter ca~heter 114 is fed through needle 112. As r~;scussed previously in conne..tion with Figure 14, the internal surface 30 configuration of housing cavity 109 causes ~ti,eter 114 to be guided into andthrough pAsseg~ ay 116, and if desired, into the attacl.ed internal catheter (not shown). This embodiment also provides the advanla~es that a guide wire can be fed through needle 112 to clear ll ,ro"~bosis or other obstructions occurring within the device or in the a~lacl,ed internal cdtheter.

SUBST~TUTE SHE~

WO 91/12838 2 ~ ~ 3 2 5 I pcr/us91/ol414 Figures 1 8 and 19 illustrate a fifth embodiment of an infusion port 120 according to this invention which may have an articulating catheter valve as described previously, or may employ a compressed rubber septum like that of the embodimentshown in Figure 17. These figures l~o~ er, illustrate that e"l,ance opening 122 can 5 form a generally elliptical configuration such that the target area for the infusion port has is greatest area when entering the device from a direction between alignmentwith the exit p~ss~aeway 126, or at right angle to exit pass~uv-. ~. In other words, a line normal to er,l,ance opening 1~ forms an obtuse angle to the axis of exit pPssageway 126. Like the prior embodiments, housing 124 has a smooth internal 10 surface which is shaped to guide an introduced cavity 128 with external catheter into exit p~ss~geway 126.
Figures 20 through 23 illustrate various means for attaching an internal oufflowcatheter 52 to an infusion port. For the embodiment of Figure 20 the infusion port features an exit end 130 defining an annular gap 132 formed between an outer 15 tubular portion 134 of the exit outlet 134 and an inner tubular portion 136. Oufflow catheter 52 is slid onto inner tube 136 and into annular gap 132. Sealing means such as a gasket or O-ring 138 can be provided to enhance the integrating of thefluid tight connection. Compression ring 140 can be used which is slid onto the connection as shown in Figure 20 to exert a co",pressive force on oufflow catheter 20 52, further securing it to the infusion port. Co,npression ring 140 also acts as a stress reliever to prevent kinking of the oufflow call,eler 52 at its connection point to the infusion port.
Figure 21 illustrates another means for connecting oufflow catheter 52 to an infusion port. In this embodiment exit end 144 has a reduced diameter projecting25 nipple 146 which oufflow catl,e~er 152 is slid over. Like the embodiment shown in Figure 20, compression ring 140 is provided which is slid onto the connection with Figure 20.
Figure 22 illustrates an infusion port exit end 150 which features reversibly oriented barbs 152 which serve to securely engage the inner surface of oufflow 30 catheter 52. Again, co,npression ring 140 is used to enhance the security of the conne~tion of the oufflow catheter to exit end 150.
Figure 23 illustrates still anvtl,er approach toward connecting oufflow catheter52 to an infusion port exit end 1 56. This embodiment, like that shown in Figure 20 defines an outer tubular portion 158, an inner tubular portion 160 with annular gap SUBSTITUT~ SH~-f 2 ~ ~

.~!.V
162 therebetween. For this embodiment, however, the inside diameter surface of outer tubular portion 158 defines groove 164. Compression ring 166 has an exterior configuration including annular barb 168 which interlocks with groove 164 when compression ring is slid onto exit end 156.
An infusion port in accordance with a sixth embodiment of this invention is shown in Figure 24 and is generally designated there by reference number 210. Infusion port 210 principally comprises housing 212, outlet plug 214, and articulating valve assembly 216.
As best shown in Figures 24 and 27, housing 212 defines a funnel-shaped entrance orifice 220, the function of which is to guide an access needle 218 toward its center.
Although orifice 220 is shown in the shape of a circular cone, other configurations could be used such as elliptical or flattened cones could be used to define the orifice opening.
Such alternative shapes could be used to decrease the profile height of the device. Any configurations used for orifice 220 must possess a decreasing cross-sectional area for the purpose 20 of guiding the access needle to a focus point. At the base of the orifice cavity shown in Figure 27 is a reduced diameter guide passageway 222. Guide passageway 222 is straight and has a diameter only slightly greater than a diameter of elements which are desired to be passed into port 210.
Outlet plug 214 is externally threaded which enables it to be attached to the end of housing 212 opposite entrance orifice 220. Outlet plug 214 defines an externally barbed projecting hollow post 224 which enables an internal outflow ., catheter 226 to be slid onto the post and attached to the infusion port as shown in Figures 24, 25 and 26. Hollow post 224 can be intentionally bent as shown in Figure 27 to prevent needle 218 from passing entirely through the device in which case it could damage outflow catheter 226. As is best shown in Figure 27, once assembled together, housing 212 and outlet plug 214 define an internal cavity which accommodates leaflet valve assembly 216. As shown in Figure 27, cavity 228 defines a pair of conical surfaces, with conical surface 230 joining with guide passageway 222 and conical surface 232 joining with exit plug post 224.
Mounting plate 234 is attached to housing 212 or formed by it integrally and provides a means of mounting infusion port 210 to support tissues within a patient using sutures, surgical staples, etc.

14a 62406-121 Wo 91/12838 ~ Q ~ 3 ~ ~i 1 PcrtUS9l/01414 Leaflet valve assembly 216 shown in Figure 27 includes a pair of elastic leafletvalve discs 236 and 238. Each of the elastic discs include slits extending from their geometric center and radially outward toward the perimeter of the elastic disc to define three separate naps or leaves 240. Elastic discs 236 and 238 are stacked 5 against one another in a manner to disalign cuts 239 so that the leaves 240 of each disc overlies the cuts in the other to enhance the sealing characteristic of the leaflet valve assembly. As shown in Figure 27, when housing 212 and outlet plug 214 are assembled together the outer periphery of elastic discs 236 and 238 are slightlycGmpressed to provide a seal which prevents flulds from leaking around the outer10 edges of the elastic disc elements.
Figure 26 shows an optional disc ring valve element 250 (not shown in Figure 27) which is provided to further enhance the sealing chara- terislics of valve assembly 216. Disc element 250 has a hole 252 through its center which has a diameter slightly smaller than the needle or catheter which port 2t 0 is designed to 1 5 accommodate. Valve element 250 is positioned to be the first element encountered by the access needle. This orie,ltdlion is provided to prevent the apexes of leaves 240 from da",ag;ng valve disc 250 or inte,~e,ing with its sealing capability.
Infusion port 210 in accordance with this invention is adapted to be accessed using a conver,lional h~ oder", c needle 218 with a sharp end which can be hollow 20 or solid depending on the i"~encJed aFpli~tion. Needle 218 can be used by itself or with an external catheter 246, which the needle is slid through so that the needle and catheter CGII ~ nalion can bs pierced through the skin and positioned into port 210 allowing the needle to be later w~lldr_--n leaving calheler 246 inside port 210 to provide fluid flow into or from the patient. The introduced catheter 246 can be 2~ threaded into outflow cdlheler 226 to any extent desired preventing u,li,)te"lional withdrawal of the introduced cdlheler.
Figure 25 shows infusion port 210 being accessed by a needle 18 and catheter 246 comh nalion. When the physician desires to access port 210 needle 218 is used to pierce the patients skin at an arsa adjacent the port entrance orifice 220 30 and the needle is pushed into the port. Gl~ance orifice 220 ,ecGives the sharp end of needle 218 and guides it toward and into guide l,Assageway ~. The guide pAcsageway then orients needle 218 and aims it to strike leaflet valve asse")bly 216 at the center of valve ele."ents 236 and 238, which is the point of intersection of the cuts 239 defining leaves or flaps 240. Guide p~Csageway 222 therefore guides SuBSTlTUT;~ S~LF l WO 91~12838 2 0 ~ ~ 2 ~ :1 PCI'/US91/01414 - 16- '~
needle 218 to strike leaflet valve asse",bly 216 in an area where cutting or damage to the elastic disc elements is minimized since the discs are most easily penetrated at their central region where their flexibility is greatest. Elastic discs 236 and 238 are inlenlionally provided with three or more leaves or flaps since it is believed that a 5 leaflet valve having a single slit defining only two leaves may not provide anacceptable resislance to damage by the pene~,dti"g needle. Such susceptibility to damage could occur since such a valve configuration is not believed to provide flaps with sufficient resiliency to bend away from the introduced needle, but would instead tend to be engaged and penet,alecl by the inserted needle 218, leading to the 10 potential for physical damage to the disc ele",enls.
In order~to provide an accep~able resislance to da",age of valve assembly 216 by needle 218 it is believed that the ,lian,eler of p~csage~vay 222 which is superimposed on disc 236 in ~igure 28 and desi~nated by reference number 254 should be no larger than one-half the .lia",eler of the slit portion of elastic discs 236 15 and 238 which is encompassed by a circle designated as diameter 256.
PassageJ~ay diall)elers 254 greater than that ratio would permit a penetrating needle with its sharp point to strike the leaflet valve as5e",~1y 216 at near its outerperimeter, where leaves 240 are not as supple and are more likely to be pierced by the access needle than the center portion. Controlling the position of penetration of 20 needle 218 also prolect~ elastic disc 250 from d~n,age which would occur if the needle struck outside of hole 252.
The conical surfaces 230 and 232 of valve cavity 228 are provided to accG"".,odate the flexing of valve leaves 240 in both di,e~ions. When access needle 218 is inserted into infusion port 210, the leaves 240 are permitted to deflect 25 toward hollow post 224. In addition, conical cavity 232 insures that the access needle 218 or other introduced filament is properly guided to pass through hollow post 224 and into internal outflow catheter 226, if desired. Upon withdrawal of access needle 218 or cdtl,~ter 246 from infusion port 210, conical surface 230 enah,es the leaves 240 of valve asse",bly 216 to be freely deflected in an opposite 30 direction.
During the step of inserting needle 218 into port 210, a positive in~ !icalion of full inse,lion is felt by the attending physician as needle 218, which is relatively rigid engages the bent portion of hollow post 224. This stop is provided to prevent accidenlal .la",age to outflow catheter 226. I lo~lcvcr, the introduced filament or SUBSTlT~-rE~ 5~

WO 91/12838 ~ ~ ~ 3 2 ~ i PCI/US91/01414 catheter 246 which is more flexible than access needle 218 can be readily threaded past hollow post 224 to provide deep insertion.
In addition to permitting the insertion of a needle 218 and catheter 246 to port210 this invention would allow a guide wire to be introduced into the port through 5 access needle 218 which could be fed through the device and into and through the internal oufflow call)eler 246 to remove thrombosis or other clogging problems.
Various other fllaments type elements could also be used with port 210 such as optical fibers, Glect,ical conductors, remote sensing systerns, etc.
Numerous ",~lerials may be used to form housing 212. Since housing 212 will 10 be subject to being struck by sharp needles which must be redirected into guide passageway 222, it is desirable to form the housing or at least the surface of orifice 220Of a hard metal ",alerial such as stainless steel or titanium or a hard ceramic.
Sott materials such as plastics, if used to form entrance orifice 220 could be subject to being gouged by needle 218, preventing proper guiding of the access needle.
15 Similarly, exit outlet plug 214 is subject to being struck by a sharp needle and should also be made of a hard metal ",alarial for the reasons ",e,l~ioned in connection with housing 212. Elastic discs 236, 238 and 250 can be made of numerous elastic materials such as silicone rubber.
An infusion port in acco,c~ance with a seventh embodiment of this invention is 20 shown in Figures 29 and 30 and is generally des;~"aled there by reference number 310. Port 310 is designed to be ~ccessed using a sharp needle which passes into the port through funnel shaped ent,ance orifice 312. Port 310 also includes a mounting pad 314 defining a gener~ Iy planer mounting surface and having apertures 316 for sutures or staples to enable the device to be secured to appropriate support 25 tissue within the patient. Internal cd~l,et~rs 318 is shown attached to port 310 and is tunneled to a desired site within the patient.
The embodiment shown in Figures 29 and 30 of this invention is presented to ~:sclose two specific improve",e"~ to devices described previously, namely a modified er,l,ance orifice 312 and an inclination of the device with respect to 30 mounting pad 314. As best shown in Figure 30, infusion port 310 is oriented such that the eccessing needle 320 shown in phantom lines enters the device at an angle desig,)a~ed as angle A from a plane parallel to mounting pad 314. The inclined orienlalion of port 310 facilitates inse,lion ot needle 320 through the patients skin 322, as shown in Figure 30.

SUBSTITUTE SHEET

~2~32~ ~

- 18- ...
The further improvement shown in Figures 29 and 30 for infusion port 310 involves a removal of the upper surface of the housing in the area defining entrance orfflce 312 shown as a sc~"~ped region 324. Removing ",dlerial in that area has the effect of slightly enlarging the target area of er,l,ance orifice 312 and also to provide 5 a smoother surface which is covered by the palientj skin, thus making the device somewhat less consF ~uous to the patient and possibly les~s irritating.
Although the features of infusion port 310 discussed in conjunction with Figures29 and 30 are employed in a port of the type shown in Figure 1, these improvements could also be incGr,~,o,aled into ports having various constructions and internal 10 features including other ports which are described in this appl~ tion and disclosed in the related app"cations.
Figure 31 illustrates infusion port 330 in accordance with an eighth embodiment of this invention. Infusion port 330 is pri",arily intended to be implanted in the chest wall region of a patient and generally comprises a funnel shaped entrance orifice 1~ 332 mounting pldtfor"~ 334, outlet tube 336, and a valving system which will be desc,il~ed in the fs la~.;.)y desc,iption.
Mounting pl.-lforl" 334 featurss apertures 338 for enabling port 330 to be secured to underline tissue within a patient using sutures, staples, etc.
As best shown in Figure 31, infusion port housing 352 also features a radially 20 projecting protuberance in the form of a lug or Isdge 340 projecting away from ent,ance orifice 332, and overlying outlet tube 336. By providing such an irregular feature on the device housing 352, the orientation of the port, and in particular outlet tube 336 and internal call,eter 318 can be readily ascertained through palpation of the device by the cl; n - ~n. As will be better desc,ibed in the following paragraphs 25 for some embodiments it is necessAry to cause the introduced filament to undergo a rather sharp turn upon erltldnce into the device, and therefore, knowing the orier,lalion of the port can aid in feeding in the introduced fila",enl. Lug 340 also provides the addilional benefit of shielding i",planted catheter 318 from needle sticks by the ~ccessing hypodermic needle 320. n improperly aimed.
Now with the reference to Figures ~ and 34, the configuration of entrance orifice 332 can be descriL,ed in more detail. As is apparenl from the figures ent,ance orifice 332 is in the from of a pair of joined conical surfaces having differing cone angles. The first conical surface 344 which forms the outer perimeter ot the orifice defines a relatively shallow Cone having a relatively large included cone angle SUBSTITUTE Sli~:E~

\~O 91/12838 2 0 ~ 3 2 ~ 1 PCI'/US91/01414 identified as angle B in Figure 34. Conical surface 344 joins with a smaller diameter conical surface 346 having an included angle idenli~ied as angle C in the Figurewhich is smaller than angle B. The shallower conical surface 344 is provided as a means of guiding inserted needle 320 toward the apex or focus area 347 of orifice 5 312. The relatively large angle B of conical surface 344 is provided so that the distance through infusion port 330 betvreen its top planer surface and the internal valve system is kept as small as reasonably possible while providing a large target area for needle 320. This total cJiAlance is significant in that presently employed catheters which are fed over needles have a relatively short length i.e. appro,(i",alely 10 two inches. It is des;r~ble to allow such existing needles and catheters to be used with port 330. and at the same time insure that the introduced catheter is securely inserted into the infusion port and er~,aged with the internal valve. Conical surface 346 is provided with a smaller included angle as a means of securely engaging introduced needle 330 and restraining it from radial motion once it is inserted and 1 ~ becomes rested in focus area 347.
While the benefits of the configuration of entrance orifice 312 are achieved in accordance with the illustrated embodiment using two joined conical segments it is fully within the scope of this invention to provide an entrance orifice defined by various other surfaces having a prog~ssively decreasin~a cone angle as measured 20 as shown in Figure 34 when moving from the outer perimeter of entrance orifice 332 to the focus area 347. For example a paraboloid surface could also be provided for orifice 332. In addiliGn en~,dnce orifice 332 could be defined by a surface which is a asy",i"et,ical in the sense of not being a surface of revolution about an axis through the orifice. Many surfaces can be imagined providing the benefits of the25 invention through providing a progressively smaller cone angle or target surface as the focus area is app(oached.
As is shown in Figure 34 the relatively large angle of conical surface 344 serves to provide a low height between the upper surface of infusion port 330 and articulating caLl,eter valve 350. As ".enliGned previously, this is advantageous since 30 slandard introduced call,ete.~ have a rel ~.iwly short length and it is desirable to make sure they are fully engaged with the articulating valve to preclude inadvertent w;ll,.l~av~il.
The focus area 347 of el,l,ance orifice 332 joins with p~ssageway 348 which leads to an articulating catheter valve asse"~ly 350. For reasons which will be SIJBSTITUTE SHEE~

WO 91/12838 ~ i 3 2 5 1 PCr/US91/01414 better described later in this specification paesageway 348 is intentionally oriented with respect to the central yenerdli"g axis of er,l,ance orifice 332 at a relatively great off-axis angle shown as angle D in Figure 32 of about 60 degrees. This off-axis orientation provides a curved p~ss~geway which is intended to prevent an introduced 5 rigid needle 320 from u"dergo.ng the turn and directly engaging articulating catheter valve asse",bly 350. This feature accordingly distinguishes infusion port 330 from the embodiments described previously which are either designed to be used with ablunt ~ccessin~ instrument or enable the inserted needle to pass directly through the articulating valve.
Housing 352 is preferably made from a hard metal material which will not be gouged or engaged by the accessing needle 320. For example, titanium or another hard metal could be used to form the entrance housing 352 or could be used merely to form the surface of ent,dnce orifice 332.
As best shown in Figures 32 and 34 infusion port housing 352 and outlet plug 15 354 define catheter valve cavity 356. As shown in the Figures cavity 356 is bounded by a pair of conical surfaces including conical surface 358 which joins with passagel~:ay 348, and conical surface 360 formed by outlet plug 354. As shown inthe Figures the included angle defined by conical surface 358 is greater than that of conical surface 360. The conical surfaces 358 and 360 are provided to enable 20 flexing of the elements co,nprising articulating catheter valve 350.
Figure 33 provides an exploded view of articulating catheter valve assembly 3~0.The valve is c~mprised of a number of individual valve elements stacked together.
The first valve element encountered when passing through valve 350 from entranceorifice 332 is a ring or donut valve 362 which is co,nprised of a ring of elastomeric 25 ."alerial with a central circular aperture 364. Infusion port 330 can be used with introduced cdll,eter-; of various dia",eters. Ring valve 362 is not provided to seal directly against the outer peri~,hery of all sizes of introduced cdll,ele,s but rather provides a re;nfor~;ng function for the remaining c~tl,~ler valve elements and also services to orient and center the introduced cd~l,eler, as will be described in more 30 detail below. The next two valve E'e.,~er~ts are leaflet valve discs 366 and 368.
Valve discs 366 and 368 each define three or more leaves 370 which form an apex at the geG",etlic center of each valve disc. As shown in Figure 33 the leaves ofeach valve disc 366 and 368 are inle.,lionally disaligned or indexed to an offset position so that the leaves are not directly overiapp.ng. This indexing is provided to SUBSTITUTE S~tEE~

WO 91/12838 2 ~ ~ 3 2 ~1 PCI/US91/01414 enhance the sealing capabilities of call ,eter valve 350. The next elements encountered in valve 350 are spacer ring 374 and finally another ring or donut valve 376 with central aperture 378. Aperture 378 has a clia"~eler which is slightly smaller than any of the catheters which infusion port 330 is designed to be used with thus 5 providing a firm perimeter seal for the introduced catheters. The elements co",prhing catheter valve 350 are st~cked logetl,er, inserted into valve cavity 356 and retained there through the threaded engage",enl between housing 352 and outlet plug 354.
Since hollow post 336 of outlet plug 354 is not oriented parallel to the plane 10 defining mounting pad 314 the hollow post is bent slightly as shown in Figure 32 as a means of orient~ling i~npla,lled catheter 318 along the plane defining portmounting l~ldl~or", 334.
Figures 34 through 37 are provided to show infusion port 330 in use and in particular show the process of introducing an-external catheter into the device.15 Figure 34 shows infusion port 330 i"~planted wi{~ patient below the surface of skin 322. In Figure 34 a hy~,oder",ic needle 320 is shown penetrating skin 322. Needle 320 is placed through cdtl,ster 382 of conventional design such as that know as an Angiocath. Needle 320 and catheter 382 are inserted through the skin and into ent,ance orifice 332. Conical surface 344 initially guides the needle into conical 20 surface 346 and finally into nesting engage",enl in tocus area 347. As statedpreviously, orifice 312 is made from a rnalerial which will not be gouged by needle 320 but rather will guide H into focus area 347.
Figure 35 shows ~ccessing needle 320 being fully inserted into focus area 347 and into p~ssageway 348. Due to the inclination of p~ss~geway 348 from the 25 er,l,ance orifice, needle 320 cannot readily pass beyond the point shown in Figure 35. Once this position is reached the clinician has positive feedback that the ele."er,l~ are oriented properly since It is apparent that the needle cannot be readily inserted any further into infusion port 310.
Once the point of Figure 35 is reacl)ed, the clinician can slide catheter 382 30 along needle 320 while holding the needle in ,l~osition, thus torcing the tip of catheter 382 further into infusion port 330. Figure 35 illustrates in pha,lto,n lines that external cdtl,eler~ 382 ~",dergoes a bend as ~t is ted into er,gager"ent with valve 350.
Catheter 382 does not necessarily become oriented prec;saly along the longitudinal axis of p?,ss~geway 348 and therefore does not always initially engage articulating SUBSTITl)TE S~l~E ~

20532!~1 WO 91/12838 PCI'/US91/0141 catheter valve assembly 350 at its center. Ring valve element 362 serves to aid in cente,i"g introduced catheter 382 to properly orient itself with respect to the r~",aining valve elements. As introduced catheter 382 is forced further into engagement with the catheter 350 it passes through leaflet valve discs 366 and 368.
5 As discussed in the prior related a, F"c~'ions, the leaves 370 can be readily opened by inse,li"g the G,~te,l,al c~ll,eter and their triangular shape serves to aid in cen~eril-g the catheter. Finally the Introduced ~tl,el~r passes through second ring valve ~!e."en~ 376 havin3 a relatively small aperture 378. Due to the cenlering f~-r,ctions provided by ring element 362 and the leaflet 2'ement 366 and 368 the introduced 10 catheter becomes accurately aligned with and forced through aperture 378. Aperture 378 is sized to provide a perimeter seal around the introduced catheter 382. A fully inserted catheter is shown in Figure 37.
The design of articulating catheter valve 350 according to this invention provides a number of signi~icanl features. By providing spacing ring 374 deflection of leaflet 15 valve leaves 370 in the direction of the ins~,lion of catheter 382 is freely permitted.
When the introduced catheter passes through the leaflet valves leaves 370 are permitted to deflect as shown in Figures 36 and 37 without signirican~ restriction caused by the presence of ring valve element 376. However upon withdrawal of introduced catheter 382, reverse deflQction of valve leaves 370 causes them to be 20 rei ,~orced by the close ~ruAi",ity of valve el~n,ent 362 thus providing a relatively greater amount of friction during withdrawal versus insertion of catheter 382. This difference in i"se,~ion versus withdrawal friction is a desirable feature since it allows the catheter to be freely inserted into the port yet firmly engages the insertedcall,eter to prevent inadvertent w;ll.dra~lval of it during infusion.
The di~ering cone angles provided by catheter valve cavity conical surfaces 358 and 360 also provide several f~"~.1ions. The relatively large angle of conical surface 358 is provided to place the p~q~s~gel,vay 348 in close proximity to catheter valve 350. This enhances the .~rgeli"g" function to ensure that catheter 382 strikes the call,~ler valve 350 at or near its center where it can be easily ~ 'srected and is guided 30 into a proper enga~en-e"l with ring valve ele."en~ 376. This large cone angle also serves to limit the degree of deflsction of ring valve element 362 thus increasing wilh.Jr~J:~.I friction. The relatively small cone angle of conical surface 360 is provided to guide the introduced catheter s"~oot~,ly into hollow post 380 and provides ~UBSTITUTE S~t~El ~ ~ 5 ~ ~ 5 ~
, ., clearance to permit relatively unrestricted deflection of leaflet valves 366 and 368 and ring valve element 376.
Figure 38 shows an alternate embodiment of an articulating catheter valve assembly designated by reference number 386. Catheter valve assembly 386 has a number of ele-ments identical to catheter assembly 350 described previously, and the common elements are designated by common reference numbers. Catheter valve assembly 386 differs from the pre-vious embodiment in that spacer ring 374 is replaced with another donut or ring valve element 388, having an internal circular aperture 390. The function of ring valve element 388 is to reinforce leaves 370 of valve disc 368 as a means of enhancing the sealing capabilities of catheter valve assembly 386. The diameter of aperture 390 is chosen to be larger than any introduced catheter 382 with which valve assembly 386 would be used.
Figure 39 shows yet another embodiment of catheter valve assembly according to this invention designated by ref-erence number 394. This embodiment also features a number of elements common to that of catheter valve assembly 350 which are identified by like reference numbers. Catheter valve 394, however, features a flapper type valve element 396 having a central flap or leaf 398. Flapper valve 396 is provided to act as a check valve providing enhanced resistance to reverse fluid leakage since flap 398 is actuated by fluid pressure into sealing engagement with valve disc 376. Flap 398 is readily deflected upon the insertion of catheter 382 or another flexible introduced filament.

While the above description constitutes the preferred embodiments of the present invention, it will be appreaciated that the invention is susceptible of modifi-cation, variation and change without departing from the proper scope and fair meaning of the accompanying claims.

Claims (42)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An implantable patient infusion device for permitting access to an internal catheter by a filament including an external catheter, wire or optical fiber comprising:
a housing having a funnel shaped entrance orifice having a decreasing cross sectional area which leads to a focus area, said housing further having a passageway communicating said focus area with an exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to said focus area and enter said passageway, an articulating catheter valve positioned within said housing passageway which normally remains closed to provide resistance to flow of fluids through said valve, yet opens to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter, and means for mounting said infusion device subcutaneously.

2. An implantable patient infusion device according to Claim 1 wherein said catheter valve comprises a leaflet valve having a generally circular flat disc of a resilient material with a plurality of cuts through said disc which cross the center of said disc.

3. An implantable patient infusion device according to Claim 2 wherein said catheter valve includes at least two discs stacked together and oriented so that said cuts of a first of said discs are not aligned with said cuts of a second of said discs.

4. An implantable patient infusion device according to Claim 2 wherein said cuts define three or more deflectable valve leaves.

5. An implantable patient infusion device according to Claim 4 wherein said passageway has a diameter not greater than one-half of the diameter defined by said leaves.

6. An implantable patient infusion device according to Claim 2 wherein said housing defines an internal cavity within which said leaflet valve is disposed.

7. An implantable patient infusion device according to Claim 6 wherein said internal cavity provides clearance for said valve leaves to deflect toward said exit orifice.

8. An implantable patient infusion device according to Claim 6 wherein said internal cavity provides clearance for said valve leaves to deflect toward said entrance to orifice.

9. An implantable patient infusion device according to Claim 6 wherein said housing is defined by a main housing defining said entrance orifice and said guide passageway and an outlet plug connected with said main housing defining said outlet orifice, said main housing and said outlet plug cooperating to define said internal cavity.

10. An implantable patient infusion device according to Claim 2 wherein said leaflet valve includes a first ring valve comprised of a disc element having a hole for sealing against an introduced filament.

11. An implantable infusion device according to Claim 10 further comprising a second ring valve positioned on the side of said leaflet valve confronting said exit passageway.

12. An implantable infusion device according to Claim 10 further comprising a spacer ring placed between said leaflet valve and said first ring valve.

13. An implantable infusion device according to Claim 2 comprising first and second ring valve elements positioned between said leaflet valve and said exit orifice wherein said first ring valve element supports said leaflet valve leaves and said second ring valve element defines a perimeter seal around said filament.

14. An implantable infusion device according to Claim 1 wherein said valve is a flapper valve element.

15. An implantable patient infusion device according to Claim 1 wherein said catheter valve comprises a cup valve having a nipple with an exit side and a valve cup for sealing engagement with said nipple, and means for resiliently urging said cup to seal against said nipple, said cup valve oriented such that said filament unseats said cup from said nipple when introduced into said infusion device.

16. An implantable patient infusion device according to Claim 1 wherein said catheter valve comprises a ball-and-seat type valve wherein said ball sealingly engages with a seat formed by said infusion device and said ball is urged to unseat from said seat when said filament is introduced into said infusion device.

17. An implantable patient infusion device according to Claim 1 wherein said infusion device comprises at least two of said articulating catheter valves positioned within said housing and separated to define an antimicrobial fluid reservoir.

18. An implantable patient infusion device according to Claim 1 wherein said infusion device further comprises an elastic septum covering said entrance orifice and having a preformed slit therethrough.

19. An implantable infusion device according to Claim 1 wherein said valve imposes less friction upon said filament being inserted through said valve than imposed upon said filament upon withdrawal of said filament.

20. An implantable infusion device according to Claim 19 wherein said valve includes at least one leaflet valve element having leaves which deflect when said filament is placed through said valve means, and means for allowing said leaves to deflect more readily in the direction of insertion of said filament as compared to removal of said filament from said device.

21. An implantable infusion device according to Claim 1 wherein said housing entrance orifice is formed from a hard material wherein a needle contacting said surface is guided into said focus area.

22. An implantable patient infusion device according to Claim 21 wherein said housing defines stop means to limit the amount of penetration of said needle in said housing after said needle passes through said valve, said stop means allowing flexible filaments to pass entirely through said device.

23. An implantable patient infusion device according to Claim 22 wherein said stop means comprises a curved portion of said passageway located before said exit orifice and which defines the limit of insertion.

24. An implantable patient infusion device according to Claim 23 wherein said accessed passageway allows said filament to be pushed through said curved passageway and into an implanted internal catheter connected to said exit orifice.

25. An implantable infusion device according to Claim 21 further comprising stop means within said passageway between said focus area and said valve for restricting the passage of said needle while permitting said introduced filament to pass through said passageway and engage said valve.

26. An implantable infusion device according to Claim 25 wherein said stop means comprises a bend in said passageway.

27. An implantable patient infusion device and catheter combination comprising:

a housing having a funnel shaped entrance orifice having a decreasing cross-sectional area which leads to a focus area, said housing further having a passageway communicating said focus area with an exit orifice, said housing causing said filament introduced into said entrance orifice to be directed to said focus area and enter said passageway, an articulating catheter valve positioned within said housing passageway which normally remains closed to provide resistance to flow of fluids through said valve, yet opens to permit said filament to pass through said valve enabling said filament to communicate with said internal catheter, means for mounting said infusion device subcutaneously, and an external catheter with a hollow core having an access needle inserted thereinto, said valve allowing said external catheter and said needle to be inserted into said device and thereafter allowing said needle to be removed leaving said external catheter inside said device.

28. An implantable patient infusion device according to Claim 1 wherein said entrance orifice has a maximum cross-sectional area at least four times that of the cross-sectional area of said passageway.

29. An implantable infusion device according to Claim 1 wherein said entrance orifice defines a surface having a first included cone angle around its outside perimeter and defining a second included cone angle adjacent said focus area which is smaller than said first included cone angle.

30. An implantable infusion device according to Claim 29 wherein said first and second included cone angles are formed by joined conical surfaces.

31. An implantable infusion device according to Claim 1 wherein said entrance orifice has a central axis generally coaxial with the exit orifice.

32. An implantable patient infusion device according to Claim 1 wherein said entrance orifice defines a generally circular perimeter lying on a plane positioned such that a line normal to said plane forms a right angle to the central axis of said exit orifice with said housing passageway shaped to guide said filament inserted into said entrance orifice to bend and become inserted through said catheter valve.

33. An implantable infusion device according to Claim 32 wherein said housing entrance orifice has a central axis generally perpendicular to the patient's skin and further defines a projection which can be detected by external palpation after said device is implanted which indicates the orientation of said device.

34. An implantable patient infusion device according to Claim 1 wherein said entrance orifice defines a plane which is oriented such that a line normal to said plane forms an obtuse angle with respect to a central longitudinal axis through said exit orifice.

35. An implantable patient infusion device for permitting access to an internal catheter by a filament including an external catheter, wire or optical fiber, comprising:
a housing defining an entrance orifice and an exit orifice with a passageway extending therebetween, said entrance orifice having a cross-sectional open area which decreases to a focus area communicating with said entrance orifice and said passageway, causing said filament introduced into said entrance orifice to be directed to enter said passageway once inserted through said entrance orifice and undergo a bend as it passes through said device, valve means which normally provides resistance to the flow of fluid through said infusion device but which is penetratable by said filament to permit said filament to pass into and through said housing passageway and means for mounting said infusion device subcutaneously.

36. An implantable patient infusion device according to Claim 35 wherein said valve means comprises an articulating valve disposed within said passageway which is opened by contact with said filament.

37. An implantable infusion device according to Claim 35 wherein said housing entrance orifice is formed from a hard material wherein a needle contacting said hard material is guided into said focus area.

38. An implantable patient infusion device according to Claim 37 wherein said housing defines stop means to limit the amount of penetration of said needle in said housing while allowing more flexible introduced filaments or catheters to be threaded further into said device.

39. An implantable patient infusion device according to Claim 38 wherein said stop means comprises a curved portion of said passageway located before said exit orifice and which defines the limit of insertion.

40. An implantable patient infusion device according to Claim 35 wherein said entrance orifice defines a generally circular perimeter lying on a plane positioned such that a line normal to said plane forms a right angle to the central axis of said passageway with said housing cavity shaped to guide said filament inserted into said entrance orifice to first bend and become inserted through said valve means.

41. An implantable infusion device according to Claim 40 wherein said housing entrance orifice has a central axis generally perpendicular to the patient's skin and further defines a projection which can be detected by external palpation after said device is implanted which indicates the orientation of said device.

42. An implantable patient infusion device according to Claim 35 wherein said entrance orifice defines a plane which is oriented such that a line normal to said plane forms an obtuse angle with respect to a central longitudinal axis through said exit orifice.