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
• • 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
  • A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
  • A61M2039/0072—Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• • 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
  • A61M2039/0226—Subcutaneous access sites for injecting or removing fluids having means for protecting the interior of the access site from damage due to the insertion of a needle
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10S604/00—Surgery
  • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable

Definitions

• the present invention relates to vascular access systems and, more specifically, to implantable vascular access ports for use in such systems.
• Implantable vascular access systems are used extensively in the medical field to facilitate the performance of recurrent therapeutic tasks inside the body of a patient.
• Such a vascular access system generally includes an implantable vascular access port attached to the proximal end of a vascular catheter.
• a typical vascular access port has a needle-impenetrable housing that encloses a fluid reservoir that is accessible from the exterior of the access port through a needle-penetrable elastomeric septum.
• the vascular access port also includes an outlet stem, which projects from the housing and encloses a fluid passageway that communicates with the fluid reservoir.
• the distal end of the catheter is mechanically coupled to the vascular access port in fluid-tight communication with the fluid reservoir using the outlet stem.
• the entirety of the system, both the vascular access port and the catheter attached thereto, is implanted in the body of a patient.
• the distal tip ofthe catheter is disposed at a predetermined location where therapeutic activity is to be effected.
• the distal tip of the catheter is either open-ended or is provided with pressure-sensitive valving that affords for one-way or two-way fluid flow therethrough during use ofthe system by medical personnel.
• the syringe associated with the hypodermic needle then is able to deliver medication or other fluids into the fluid reservoir. These flow through the outlet stem ofthe vascular access port and through the catheter attached thereto, thereby to become infused into the body of the patient at the distal tip ofthe catheter.
• the syringe is able to aspirate bodily fluids from the vicinity ofthe distal tip ofthe catheter by withdrawing such fluids along the catheter, through the outlet stem and the fluid reservoir of the vascular access port, and lastly up the hypodermic needle into the syringe.
• the septum of that vascular access port be possessed of specific properties
• Needle retention force refers to the tendency of a septum to resist the removal therefrom ofthe shaft of any such hypodermic needle Inadequate needle retention force can allow the tip of the shaft of a hypodermic needle to become withdrawn inadvertently from a septum, even after the tip of the shaft of the hypodermic needle has penetrated the septum to the fluid reservoir in the vascular access port This is quite painful to the patient and disruptive ofthe therapeutic process
• the attention of medical personnel will, at the very least, need to be redirected to the penetration ofthe tip ofthe hypodermic needle through the septum of the vascular access port If the inadvertent withdrawal of the tip of the shaft of the hypodermic needle from the septum is not detected, however, fluids in the syringe associated with the hypodermic needle will not even enter the fluid reservoir of the vascular access port when infusion of those fluids is undertaken Instead, the fluids will be injected subcutaneously into the pocket in which the vascular access port is implanted Necrosis of the tissue surrounding the implantation pocket will occur as a result, complicating therapeutic activities and frequently requiring the removal and reimplantation at another site ofthe entire vascular access system
• a corollary aspect of the needle retention force imposed on the shaft of a hypodermic needle by any given septum is the degree of force required to cause the tip of that hypodermic needle to advance through the septum from the exterior surface to the interior surface thereof This is referred to as the needle penetration force
• the needle retention force and the needle penetration force for a given septum are generally identical, but oppositely directed.
• the amount ofthe needle penetration force be within a range that facilitates the labors of medical personnel
• the needle penetration force for a given septum cannot be substantial, or the process of accessing the fluid reservoir ofthe associated vascular access port with the tip ofthe shaft of a hypodermic needle will be difficult for medical personnel and dangerous to the patient
• the needle penetration force for a given septum should be distinctly different and usually greater than the force required to advance the tip ofthe shaft of a hypodermic needle through the tissue ofthe patient at the implantation site for the vascular access port If such is the case, medical personnel utilizing a hypodermic needle to access the fluid reservoir in a vascular access port will be informed by feel when the tip ofthe hypodermic needle has actually encountered and is being advanced through that septum Such tactile feedback has been reported to be particularly useful
• the sealing effectiveness, the needle retention force, and the needle penetration force for a given septum are each in part related to the amount and types of forces applied to the septum by the housing ofthe vascular access port in which the septum is installed While torsional forces and tensions are on occasion applied to a septum by ie housing ofthe vascular access port in which the septum is installed, it is more common that the forces applied thereto by a housing are directed inwardly toward the body ofthe septum In general, the greater the inwardly directed forces that are applied to a septum the greater will be the sealing effectiveness of the septum about the shaft of a hypodermic needle Also, the larger will be the needle retention force and the needle penetration force that are imposed on the shaft of that hypodermic needle by thai septum The inwardly directed forces imposed on an installed septum by the housing of a vascular access port must, however, not be so great that penetrating the septum with the tip of a hypodermic needle results in coring of the septum When the tip of a hypo
• vascular access port makes it difficult to predict with precision the location in cross section ofthe septum of that vascular access port that will be penetrated by a hypodermic needle on any given occasion
• the septum installed in the vascular access port should thus exhibit substantially uniform needle sealing, needle retention, and needle penetration characteristics across the entire area of the septum exposed to needle penetration In this manner the quality ofthe interaction between a septum and the shaft of a penetrating hypodermic needle will be substantially independent ofthe location at which the tip ofthe hypodermic needle actually enters the septum
• a septum be so installed in the housing of a vascular access port as to present to the exterior of the vascular access port at least a minimum amount of exposed needle target area. This facilitates the locating of the septum by palpation of the skin of the patient at the implantation site of the vascular access port. It also reduces the chances that any given probe by the tip ofthe shaft of a hypodermic needle through the tissue ofthe patient at the implantation site will miss the septum entirely.
• Missing the needle target area of the septum of the vascular access port is a painful event for the patient. It is an event that also presents major risks. If the miss is not detected by medical personnel, the fluids in the associated hypodermic syringe could be injected subcutaneously into the pocket in which the vascular access port is implanted, producing consequences already discussed above.
• a large needle target area in the septum of a vascular access port also decreases the likelihood that the desirable repeated selective penetration of the septum by the tip of a hypodermic needle will inadvertently become concentrated over time in any small region of the septum.
• the dispersal of puncture sites over a large needle target area slows the destructive effects of needle penetration, such as septum coring, and thus contributes to septum longevity.
• Circular septums that exhibit a desired minimum amount of needle target area necessitate vascular access ports that are correspondingly large in each direction parallel to the plane of the septum.
• Vascular access ports of such proportion can only be implanted in correspondingly large tissue areas in the body of a patient, such as in tissue areas in the thigh or in the chest. Occasionally in robust adults, implantation in the upper arm is also a possibility.
• vascular access port at these locations is not, however, entirely convenient for repeated ongoing therapy. At these locations, reaching the vascular access port with the tip of a hypodermic needle requires that the patient at least partially undress and remain so undressed during the entire time that the vascular access port is being involved in therapeutic activity.
• vascular access port that uses a round septum also precludes the use of such a vascular access port with small children or with infants, as there are simply no large tissue areas in the bodies of such potential patients
• a vascular access port to accommodate a round septum also has consequences relative to the manner in which implantation of the vascular access port must occur
• Vascular access ports with round septums are correspondingly relatively extensive in each direction parallel to the plane of the septum
• relatively long incisions must be made in the skin of a patient when forming the subcutaneous pocket in which the vascular access port is to be implanted
• the longer the incision the greater will be the duration ofthe healing process that must occur at the implantation site before therapy can commence using the vascular access port
• Another object ofthe present invention is to provide a vascular access port that has a conventional fluid capacity, but that is capable of insertion through a small incision into a subcutaneous pocket in the body of a patient
• An additional object ofthe present invention is to provide a vascular access port as described above that can be implanted in smaller tissue areas in the body of an adult patient, and particularly in the extremities thereof
• a related object ofthe present invention is to provide a vascular access port as described above that can be used with small children and infants
• vascular access port as described above, in which coring ofthe septum is minimized and in which an acceptably large needle target area is maintained
• vascular access port that is not limited to using a circular septum in order to produce in the installed septum desired needle sealing, needle retention, and needle penetration characteristics
• Still another object ofthe present invention is to provide vascular access ports of the types described above in which characteristics, such as needle sealing, needle penetration, and needle retention in the installed septum, are uniform throughout the cross section ofthe septum
• an implantable vascular access port in which an elongated, needle-penetrable, elastomeric septum is installed in a needle- impenetrable housing
• the housing is made up of a base and a cooperatively interacting cap
• the base of the housing has a floor with a continuous encircling sidewall upstanding therefrom The sidewall terminates remote from the floor in a septum support shoulder The space interior ofthe base corresponds to the fluid reservoir of the access port
• the cap of the housing has a top wall with a skirt depending therefrom
• the skirt ofthe cap is configured to receive the end ofthe sidewall ofthe base that carries the septum support shoulder Formed through the top wall of the cap is an access aperture that communicates with the fluid reservoir ofthe access port, when the sidewall ofthe base is received in the cap
• the access aperture has an elongated outer periphery defined by a continuous encircling rim
• the rim may be elliptical, oval, polygonal, or parabolic-ended Extending radially into the access aperture from the side ofthe rim ofthe access aperture adjacent to the exterior of the vascular access port is a septum retention lip
• the septum retention lip assumes a parallel, spaced-apart relationship to the septum support shoulder, when the sidewall ofthe base is received in the cap ofthe housing
• a vascular access port also includes a septum that is elongated in a cross section taken in the plane thereof
• a septum according to the teachings ofthe present invention can have a periphery in the plane thereof that is, by way of example and not limitation, substantial elliptical, substantially oval, substantially polygonal, or provided with extreme ends that are substantially parabolic
• the natural configuration of a septum will be used to refer to the condition of the septum, when the septum is free ofthe forces that will eventually be imposed on tht septum by the housing into which the septum is to be installed
• the cross section ot the natural configuration ofthe septum in the plane thereof is generally more expansive than the access aperture into which the septum becomes installed
• the periphery of the septum in the natural configuration thereof is substantially geometrically proportional to the nm ofthe access aperture
• the penphery ofthe septum in the natural configuration thereof has a thickness that is greater than the distance between the septum support shoulder and the septum retention lip, when the sidewall of the base is received in the cap ofthe housing
• the septum is disposed in the access aperture with the periphery ofthe septum positioned between the septum retention lip on the cap and the septum support shoulder on the base ofthe housing
• the opposite faces ofthe periphery ofthe septum are, as a result, urged toward each other by the septum retention lip and the septum support shoulder, when the housing is assembled
• a septum according to the teachings ofthe present invention includes an outer face on the side ofthe septum that is oriented toward the exterior ofthe housing of the vascular access port in the installed condition ofthe septum and an inner face on the side ofthe septum opposite from the outer face.
• support means is integrally formed with the septum for preventing buckling of the septum in the installed configuration thereof.
• such support means may comprise a needle target dome on the outer face ofthe septum.
• the target dome may be smaller in extent than the outer face of the septum.
• the target dome is displaced toward the exterior ofthe housing ofthe vascular access port by forces imposed on the periphery ofthe septum in the installed condition thereof.
• An alternate or supplementary form of a support means may comprise a reinforcing plug on the inner face of the septum.
• the reinforcing plug may be smaller in extent than the inner face of the septum.
• the reinforcing plug is displaced toward the interior of the housing of the vascular access port by forces imposed on the periphery of the septum in the installed condition thereof.
• a pair of orthogonal axes can be associated with the septum in the plane thereof
• the longitudinal axis of the septum intersects the periphery of the septum at respective longitudinal extremes ofthe septum, and these longitudinal extremes of the septum are inwardly displaced from the natural configuration of the septum into the installed configuration ofthe septum by substantially equal nonzero first displacements that are directed along the longitudinal axis ofthe septum.
• the lateral axis of the septum intersects the periphery of the septum at respective medial extremes ofthe septum.
• the medial extremes ofthe septum are inwardly displaced from the natural configuration of the septum into the installed configuration ofthe septum by substantially equal nonzero second displacements that are directed along the lateral axis ofthe septum.
• the periphery of the septum and the rim of the access aperture in which the septum is installed are so configured that the ratio of the combination of the first displacements to the distance between the longitudinal extremes of the septum in the natural configuration ofthe septum is equal to the ratio ofthe combination of the second displacements to the distance between the medial extremes of the septum in the natural configuration ofthe septum.
• the ratio of the combination ofthe first displacements to the distance between the longitudinal extremes ofthe septum in the natural configuration thereof is, however. equal to the strain imposed along the longitudinal access ofthe septum in the installed configuration of the septum.
• the ratio of the combination of the second displacements to the distance between the medial extremes ofthe septum in the natural configuration ofthe septum is equal to the strain along the medial axis ofthe septum in the installed configuration of the septum Therefore, in installing a septum in an access apeture according to the teachings ofthe present invention, the strain along the longitudinal axis of the septum is preferabh equal to the strain along the lateral axis of the septum
• the distance between a first pair of points on the periphery of the septum that are disposed on the longitudinal axis ofthe septum is reduced in the installed configuration ofthe septum relative to the natural configuration of the septum by a first compression distance.
• the distance between a second pair of points on the periphery of the septum disposed on the lateral axis thereof is reduced in the installed configuration relative to the natural configuration by a second compression distance.
• the ratio ofthe first compression distance to the distance between the first pair of points in the natural condition of the septum is equal to the ratio ofthe second compression distance to the distance between the second pair of points in the natural condition ofthe septum.
• Figure 1 is a perspective view of an implantable vascular access system including a vascular access port incorporating teachings of the present invention attached to a vascular catheter and implanted in the body of a patient;
• Figure 2 is an enlarged perspective view of the vascular access port of Figure I and the portion of the catheter immediately attached thereto;
• Figure 3 is an exploded perspective view of the components of the vascuiai access port of Figure 2 with the catheter disassembled therefrom;
• Figure 4 is a cross-sectional elevation view of the cap of Figure 3 taken along section line 4-4 shown therein;
• Figure 5 is a cross-sectional elevation view of the base of Figure 3 taken along section line 5-5 shown therein;
• Figure 6 is a cross-sectional elevation view of the base of Figure 5 received in the cap of Figure 4;
• Figure 7 is a cross-sectional elevation view of the natural configuration of the uninstalled septum of Figure 3 taken along section line 7-7 shown therein, which coincides with the longitudinal axis ofthe septum;
• Figure 8 is a cross-sectional elevation view ofthe assembled vascular access port of Figure 2 taken along section line 8-8 shown therein;
• Figure 9 is a diagram that contains comparative plan views superimposed on a common coordinate axis of a septum incorporating teachings of the present invention, first in a natural condition thereof free of externally imposed forces and shown in phantom, and second in an installed condition thereof shown in solid line with the outer periphery displaced radially inwardly, as when disposed in the vascular access port in Figures 2 and 8;
• Figure 10 is a perspective view of a quadrant of a virtual septum incorporating teachings ofthe present invention in the natural configuration thereof overlaid by a finite element mesh;
• Figure 1 1 is a perspective view of the quadrant of the virtual septum and associated finite element mesh of Figure 10 showing gradients of hydrostatic pressure produced therein by the application along the longitudinal and lateral axes of the virtual septum of a 6.4 percent radially inwardly directed strain;
• Figure 12 is a perspective view of a diagram ofthe quadrant ofthe virtual septum and associated finite element mesh of Figure 10 showing gradients of hydrostatic pressure produced therein by the application along the longitudinal and lateral axes of the virtual septum of a 6.4 percent radially inwardly directed strain in addition to the application to the periphery of the virtual septum of an 8.0 percent axial compression.
• Figure 13 is a diagram containing comparative elevation profile views superimposed on a common axis of symmetry ofthe septum of Figure 3 in the natural configuration thereof shown in phantom and in the installed configuration thereof shown in solid line;
• Figure 14 is a comparative plan view of a first family of elliptical septums of identical length that incorporate teachings of the present invention and exhibit differing configurations
• Figure 15 is a comparative plan view of a second family of elliptical septums of identical width that incorporate teachings of the present invention and exhibit differing configurations;
• Figure 16 is a comparative plan view of a truly elliptical septum in dashed line superimposed on the plan view of an oval septum that incorporates teachings and obtains benefits of the present invention
• Figure 17 is a comparative plan view of a truly elliptical septum in dashed line superimposed on the plan view of a septum in solid line having parabolic extremes that incorporates teachings and obtains benefits ofthe present invention.
• Figure 18 is a comparative plan view of a truly elliptical septum in dashed lines superimposed on the plan view of a septum in solid line having a polygonal periphery that incorporates teachings and obtains benefits of the present invention
• a patient 10 is shown having a chest 12, a right arm 14, and a forearm 15 associated therewith.
• a vein 16 extends from forearm 15 through arm 14 and into chest 12.
• vascular access port 18 Subcutaneously implanted in forearm 15 of patient 10 is one embodiment of a vascular access port 18 incorporating teachings ofthe present invention
• vascular access port 18 is also implanted with vascular access port 18 .
• Catheter 20 enters vein 16 in the proximity of vascular access port 18 and extends within vein 16 from forearm 15, through arm 14, and into chest 12 of patient 10
• the distal end 24 of catheter 20 has been advanced through vein 16 to a desired location within chest 12 of patient 10 near the heart thereof.
• Distal end 24 of catheter 20 is either open, or is provided with such pressure-sensitive valving as affords for one-way or two-way fluid flow therethrough according to the intended use of vascular access port 18 and catheter 20.
• the combination of vascular access port 18 and catheter 20 is, therefore, capable A functioning as a vascular access system.
• that component of the vascular access system is susceptible to implantation in small tissue areas in the body of patient 10, such as in forearm 15 thereof.
• This capability of vascular access port 18 is related not to any reduction in the overall volume occupied by vascular access port 18, but rather to the configuration of that volume in a vascular access port according to teachings of the present invention. That configuration in the vascular access port is a primary consequence of the shape of the elastomeric septum installed therein.
• vascular access port 18 can be used as a component of a vascular access system that will benefit small children and infants.
• a needle 26 of a hypodermic syringe 28 is used to deliver medication transcutaneously to the fluid reservoir in vascular access port 18
• the medication flows through catheter 20 and is discharged within the body of patient 10 at distal end 24 of catheter 20.
• hypodermic syringe 28 can be used to aspirate bodily fluid samples from the vicinity of distal end 24 of catheter 20. These bodily fluids are drawn thereby into and through catheter 20 to the fluid reservoir in access port 18, and therefrom through needle 26 into hypodermic syringe 28.
• vascular access port 18 includes a needle-impenetrable housing 40 that encloses a fluid reservoir not visible in Figure 2.
• An elastomeric. needlf- penetrable septum 91 affords for repeated selective access to the fluid reservoir in housing 40 when penetrated by the tip of the needle of a hypodermic syringe, such as hypodermic syringe 28 shown in Figure 1
• the portion of septum 91 exposed to the exterior of vascular access port 18 is referred to as the needle target area of septum 91 .
• the needle target area of septum 91 has a maximum extent, or length L ⁇ , and a width W ⁇ measured perpendicular to length Lj thereof.
• the needle target area of septum 91 therefore, has a generally elongated configuration.
• the term "elongated" is intended to connote that the corresponding structure has overall dimensions measured in orthogonal directions that are unequal.
• vascular access port 18 has a maximum extent, or length L between a proximal end 30 and an opposed distal end 32 to wh.di proximal end 22 of catheter 20 is attached
• the length L ⁇ of vascular access y>,-,n 18 between proximal end 30 and distal end 32 thereof is greater than the width W of vascular access port 18 measured perpendicular to the length L A thereof Accordingly, access port 18 is also elongated within the meaning of that term intended herein
• the degree of elongation in different structures can be compared using various normalizing parameters that are derivable for a given structure from the length and width thereof
• a first such parameter is aspect ratio
• the aspect ratio of a structure is the ratio of the length of the structure divided by the width of the structure.
• a structure that lacks elongation has a width equal to the length thereof
• the aspect ratio of a structure that lacks elongation is equal to 1 00
• all elongated structures have aspect ratios that are greater than 1 00 Larger aspect ratios reflect more extreme degrees of elongation
• a second such parameter of elongation is eccentricity
• the eccentricity E of an elongated structure of length L and width W is determined from the following equation
• a structure that lacks elongation has a width W equal to the length L thereof
• the eccentricity of a structure that lacks elongation is equal to zero. All elongated structures have eccentricities that are greater than zero and less than 1.00 Larger eccentricities reflect more extreme degrees of elongation.
• housing 40 includes an elongated cap 42 and a correspondingly elongated base 44
• Cap 42 is a cup-like structure that comprises a top wall 56 and a skirt 46 depending therefrom that terminates in a suture lip 54 As illustrated in Figure 3.
• skirt 46 continuously encircles top wall 56 of cap 42. Nonetheless, appropriate discontinuous non-encircling structures attached to or depending from top wall 56 could with a complementary configuration of base 44 function with the same efficacy as does skirt 46 in vascular access port 18.
• Receiving chamber 60 is intended to closely nestle base 44, the other component of housing 40, in the manner illustrated in Figure 6.
• Receiving chamber 60 opens outwardly for that purpose to the exterior of cap 42 at a housing assembly entrance 61 that is also shown to best advantage in Figure 4
• Assembly entrance 61 is substantially encircled by suture lip 54
• An elongated target aperture 59 is formed through top wall 56 of cap 42 to receiving chamber 60.
• Cap 42 has a proximal end 50 and an opposed distal end 52 at which a U-shaped stem slot 62 is formed through suture lip 54 and skirt 46.
• a plurality of circumferentially spaced suture channels 64 in exterior surface 48 of cap 42 extends from top wall 56 to suture lip 54.
• suture lip 54 is provided in each instance with a respective suture hole 66.
• Suture holes 66 are used to secure vascular access port 18 in a subcutaneous implantation pocket.
• Base 44 of housing 40 includes a floor 68 and a continuous encircling sidewall 70 upstanding therefrom.
• the interior surface 76 of base 44 includes the floor and the walls of a fluid reservoir 78 of vascular access port 18 that is formed interior of base 44.
• Base 44 has a proximal end 72 and a distal end 74 from which projects a stem housing 80 of U-shaped cross section.
• a passageway 82 extends longitudinally through stem housing 80 to fluid reservoir 78.
• Stem housing 80 is received in stem slot 62 of cap 42, when sidewall 70 of base 44 is nestled in receiving chamber 60 of cap 42 in the manner shown in Figure 6.
• Vascular access port 18 also includes a substantially cylindrical outlet stem 84 shown in perspective in Figure 3 as including a proximal end 86 that is configured to be received within passageway 82 in stem housing 80.
• the distal end 88 of outlet stem 84 is used to couple vascular access port 18 with catheter 20.
• base 44 of housing 40 with an outlet stem, such as outlet stem 84. that is integrally formed therewith.
• a passageway 90 extends longitudinally through outlet stem 84 from proximal end 86 to distal end 88 thereof. As a result, passageway 90 communicates with fluid reservoir 78 when proximal end 86 of outlet stem 84 is received in passageway 82 of stem housing 80.
• Receiving chamber 60 in cap 42 is so configured as to enclose the end of sidewall 70 of base 44 remote from floor 68 thereof.
• base 44 enters receiving chamber 60 through assembly entrance 61 and advances thereinto until suture lip 54 on cap 42 is flush with the outer surface 69 of floor 68 of base 44.
• Stem housing 80 is received in stem slot 62, so that outlet stem 84 projects outwardly from the assembly.
• Target aperture 59 then affords communication between the exterior of housing 40 and fluid reservoir 78 therein.
• Cap 42, base 44, and outlet stem 84 can each be made from a medical grade plastic. In the alternative, each can be manufactured from other needle-impenetrable materials, such as metals, ceramics, or composites. Cap 42, base 44, and stem 84 can individually be made from different materials, if desired.
• Figure 3 also depicts the final component of vascular access port 18, an elastomeric needle-penetrable septum 91. As depicted in Figure 3 septum 91 is an elongated, substantially planar structure with an outer periphery 138. In a cross section of septum 91 taken in the plane P thereof, periphery 138 of septum 91 is substantially elliptical.
• septum 91 has a central axis A c that is perpendicular to plane P and passes through the center 164 of the top surface of septum 91.
• septum 91 When installed in vascular access port 18, septum 91 is positioned between base 44 and cap 42. As a result, septum 91 seals target aperture 59, but septum 91 nonetheless also enables repeated selective access to fluid reservoir 78 by the tip of the shaft of a hypodermic needle that is penetratingly advanced through septum 91.
• Septum 91 is made from a medical grade silicone or other comparable materials having a Shore "A" durometer in a range from about 28 to about 85. More preferably, the Shore "A" durometer of the material of septum 91 is in a range from about 35 to about 75, and most preferably in a range from about 45 to about 65.
• skirt 46 of cap 42 has an inner surface 92 that extends between an upper end 94 and a lower end 96 thereof. Except at stem slot 62 formed therethrough, skirt 46 encircles receiving chamber 60. Formed in lower end 96 of skirt 46 is an alignment notch 106. Alignment notch 106 is substantially continuous in the embodiment illustrated, being interrupted by stem slot 62, but alignment notch 1 h may be configured otherwise, provided that corresponding structures on base 4- .r. e appropriately modified in a complementary manner.
• septum retention lip 98 Radially inwardly projecting from inner surface 92 at upper end 94 thereof is a continuous septum retention lip 98.
• Septum retention lip 98 terminates at a free inner surface 100 that encircles target aperture 59 in a continuous manner.
• Extending between inner surface 92 of skirt 46 and inner surface 100 of septum retention lip 98 is a bearing surface 102 that is continuous in the embodiment illustrated.
• a first gripping ridge 104 projects from bearing surface 102 normal thereto at a location adjacent to inner surface 100 of septum retention lip 98.
• First gripping ridge 104 is continuous in the embodiment of vascular access port 18 illustrated.
• sidewall 70 of base 44 has an outer surface 1 18 and an inner surface 1 16 that encircles fluid reservoir 78.
• Alignment shoulder 124 Extending radially outward from outer surface 1 18 of sidewall 70 at floor 68 is an alignment shoulder 124 that is substantial, v continuous in the embodiment illustrated, being interrupted by stem housing 80 Alignment shoulder 124 may be configured otherwise, provided that corresponding structures on cap 42 are appropriately modified in a complementary manner.
• Sidewall 70 of base 44 extends from floor 68 to a free septum support shoulder 120 that is continuous in the embodiment illustrated. Upstanding from septum support shoulder 120 adjacent to inner surface 1 16 of sidewall 70 is a second gripping ridge 122 that is also continuous in the embodiment illustrated.
• Figure 6 depicts the relationship among the structures of cap 42 and base 44, when base 44 is received in cap 42.
• Sidewall 70 of base 44 is configured to fit tightly within receiving chamber 60 of cap 42 with alignment shoulder 124 on base 44 fitting into alignment notch 106 on cap 42.
• Bearing surface 102 of septum retention lip 98 is. as a result, positioned in parallel spaced-apart relationship to septum support shoulder 120, separated therefrom by a distance D.
• the portion of receiving chamber 60 not filled in this manner by base 44 and not intended to function as part of fluid reservoir 78 comes instead to perform as a septum receiving aperture 126.
• the portion of inner surface 92 of skirt 46 of cap 42 above septum support shoulder 120 correspondingly comes to function as a continuous rim 128 of septum receiving aperture 126.
• Rim 128 of septum receiving aperture 126 is elongated in shape, and in the embodiment illustrated in harmony with the cross-section of periphery 138 of septum 91 is substantially elliptical. Nonetheless, other configurations for rim 128 of septum receiving aperture 126 are within the scope of the present invention.
• rim 128 may thus be elliptical, oval, polygonal, or parabolic-ended.
• target aperture 59 communicates between the exterior of housing 40 and one side of septum receiving chamber 126.
• the opposite side of septum receiving chamber 126 communicates with fluid reservoir 78
• target aperture 59 and septum receiving aperture 126 together function as an access aperture 130 through which fluid reservoir 78 communicates with the exterior of housing 40.
• septum 91 an elongated septum, such as septum 91, is geometrically proportional to, but larger than, the shape ofthe rim ofthe access aperture ofthe vascular access port in which the septum is to be installed.
• the ramifications of this feature of septum 91 on the interactions of the elements of housing 40 with septum 91 is investigated in substantial detail in due course.
• septum 91 A cross-sectional elevation view of septum 91 in the natural configuration thereof, free of external forces, is shown in Figure 7
• septum 91 can be seen to include a septum body 136 having an outer face 140 on the side of septum 91 that is oriented to the exterior of housing 40 when septum 91 is installed therein.
• septum body 136 has an inner face 142 on the opposite side of septum 91 from outer face 140 thereof. At periphery 138, septum body 136 assumes a minimum thickness T p between outer face 140 and inner face 142. About central axis A c of septum 91, however, the central thickness T c of septum body 136 is a maximum, greater than peripheral thickness T p thereof. The increase in thickness of septum body 136 toward center 164 of septum 91 is a result of the formation of structures at outer face 140 and inner face 142, respectively.
• needle target dome 144 Radially inwardly from periphery 138 of septum 91, outer face 140 of septum body 136 bulges laterally outwardly from septum body 136 to form a needle target dome 144. Accordingly, needle target dome 144 is smaller in extent than is outer face 140 of septum body 136.
• needle target dome 144 is enclosed within a boundary 145 that is elongated.
• septum 91 When septum 91 is assembled in housing 40 in the manner of Figure 2, it is the portion of outer face 140 of septum body 136 within boundary 145 of needle target dome 144 that is exposed to the exterior of access port 18 through target aperture 59.
• the surface of needle target dome 144 is substantially coincident with the needle target area of septum 91. In most instances, it can be anticipated that boundary 145 of needle target dome 144 will coincide substantially with inner surface 100 of septum retention lip 98.
• boundary 145 of needle target dome 144 may appear in Figure 3 to be similar in shape to periphery 138 of septum 91 , this relationship also need not necessarily be maintained according to the teachings ofthe present invention.
• inner face 142 of septum body 136 bulges laterally outwardly from septum body 136 to form a reinforcing plug 146. Accordingly, reinforcing plug 146 is smaller in extent than is inner face 142 of septum body 136.
• reinforcing plug 146 is enclosed within a boundary 147 that is elongated much in the manner of boundary 145 of needle target dome 144.
• septum 91 When septum 91 is assembled in housing 40, it is the portion of inner face 142 within boundary 147 of reinforcing plug 146 that is exposed to fluid reservoir 78 on the interior of vascular access port 18.
• boundary 147 of reinforcing plug ⁇ ⁇ 4f engages inner surface 1 16 of sidewall 70 of base 44.
• boundary 147 of reinforcing plug 146 will assume substantially the same shape as the cross section of fluid reservoir 78 taken in a plane parallel to floor 68 of base 4 ⁇ . Nonetheless, within the scope ofthe teachings ofthe present invention, this relationship need not necessarily always exist.
• boundary 147 of reinforcing plug 146 may be similar in shape to periphery 138 of septum 91, this relationship also need not necessarily be maintained according to the teachings ofthe present invention.
• boundary 145 of needle target dome 144 precisely overlies boundary 147 of reinforcing plug 146. This is a result of structural relationships existing among the needle-impenetrable elements of housing 40.
• inner surface 100 of septum retention lip OR on cap 42 is of the same size and shape as inner surface 1 16 of sidewall 70 of bare ⁇ 4 Therefore, target aperture 59, which is bounded by inner surface 100 of septum retention lip 98, corresponds in size and shape to the cross section of fluid reservoir 78 that is bounded by inner surface 1 16 of sidewall 70 of base 44.
• Access port 18 is assembled by initially positioning septum 91 within cap 42 such that needle target dome 144 is received within target aperture 59.
• the portion of ou-ei face 140 of septum body 136 that is radially outside of boundary 145 of needle target dome 144 comes as a result to rest against bearing surface 102 on septum retention lip 98.
• Base 44 is then inserted into cap 42, sandwiching septum 91 therebetween.
• Septum support shoulder 120 is urged against the portion of inner face 142 of septum body 136 that is radially outside of boundary 147 of reinforcing plug 146. This seals access to fluid reservoir 78 through target aperture 59.
• the result is shown in cross section in Figure 8, which depicts the installed configuration of septum 91.
• Cap 42 is secured to base 44 by ultrasonically welding alignment shoulder 124 of base 44 in alignment notch 106 of cap 42.
• various medical grade adhesives or conventional mechanical connections can be used to secure cap 42 and base 44.
• Ultrasonic welding or a medical grade adhesive is also used to secure proximal end 86 of stem 84 in passageway 82 of stem housing 80.
• Housing 40 interacts with the installed configuration of elongated septum 91 to produce substantially uniform stress in septum 91 in plane P thereof.
• substantially uniform stress of this type in the installed configuration of septum 91 results in uniform needle sealing, needle penetration, and needle retention characteristics throughout the entire cross section of septum 91. Needle coring in septum 91 is minimized by adjusting to within acceptable bounds the degree of uniform stress of this type produced in the installed configuration of septum 91.
• Catheter 20 is coupled to stem 84 by sliding proximal end 22 of catheter 20 over free distal end 88 of stem 84. A cylindrical locking sleeve 148 is then advanced along catheter 20 toward and into abutment against vascular access port 18.
• vascular access port 1 To implant vascular access port 1 8, a subcutaneous pocket is first created in which to receive vascular access port 18. For this purpose an incision is made in the skin of patient 10 at the intended implantation site, and a pocket is enlarged therethrough below the skin. Vascular access port 18 is inserted through the incision into the subcutaneous pocket and is secured therein as desired using suture holes 66.
• Outlet stem 84 which is positioned at distal end 74 of base 44 in alignment with the longitudinal axis of housing 40, enters into the subcutaneous pocket last, following the balance of vascular access port 18.
• vascular access port 18 can be secured in the subcutaneous pocket before medical personnel are required to attend to the implantation of vascular catheter 20.
• Catheter 20 may even be coupled to outlet stem 84 of vascular access port 18 after access port 18 has been entered into and secured within the subcutaneous implantation pocket.
• outlet stem 84 on an extreme end of housing 40 allows the incision made in the skin of patient 10 to be only so long as will accommodate the width W ⁇ , rather than the length L ., of vascular access port 18
• the elongation of vascular access port 18 thus reduces the length of the incision required for the implantation thereof.
• the elongation in vascular access port 18 is facilitated in largest measure by the elongation of septum 91 that is installed therein.
• access means are provided in housing 40 for permitting select fluid communication through septum 91 with fluid reservoir 78 by the tip of the needle of a hypodermic syringe and for producing substantially uniform stress in septum 91 in the installed configuration thereof.
• one embodiment of such an access means includes access aperture 130 shown to best advantage in Figure ⁇
• septum 91 disposed in access aperture 130 as in Figure 8. selected fluid communication can be effected at will with fluid reservoir 78 only by passing through septum 91 the tip ofthe needle of a hypodermic syringe, such as hypodermic syringe 28 shown in Figure 1
• constriction means are provided for displacing periphery 138 of septum 91 radially inwardly in plane P of septum 91
• one embodiment of such constriction means comprises a rim, such as rim 128 of access aperture 130, which has a shape in the plane thereof that is geometrically proportional to, but smaller than, the cross section of periphery 138 ot septum y l in plane P thereof
• rim 128 radially inwardly displaces periphery 138 of septum 91 in the plane thereof in such a manner as has been found to produce substantially uniform hydrostatn- pressure in the portion of septum 91 accessible to needle penetration
• a natural configuration periphery 154 of septum 91 is shown in phantom, which corresponds to the profile ofthe periphery of septum 91 prior to being disposed in access aperture 130 of housing 40
• an installed configuration periphery 156 of septum 91 illustrating the size ofthe periphery of septum 91 once septum 91 is positioned within access aperture 130 of housing 40
• superimposed on natural configuration periphery 154 and installed configuration periphery 156 in Figure 9 is a coordinate axis
• the origin o the coordinate axis coincides with center 164 of septum 91 in both the natural configuration and the installed configuration thereof
• the first ofthe axes ofthe coordinate axis is an X-axis that is coincident with the maximum extent of septum 91 and therefore with the longitudinal axis 158 thereof in both the natural configuration and the installed configuration
• the second of the axes of the coordinate axis is a Y-axis that is
• the natural configuration of septum 91 has a natural configuration periphery 154 with a maximum extent or length L, that is reduced in the installed configuration of septum 91 to an installed configuration periphery 156 ha iii" a maximum extent or length L 2
• septum 91 in the natural configuration thereof has a natural configuration periphery 154 with a maximum extent measured perpendicular to longitudinal axis 158 that is equal to a width W,
• This dimension of septum 91 decreases in the installed configuration thereof to produce an installed configuration periphery 156 having a corresponding width W 2
• a point P ⁇ x ⁇ y on natural configuration periphery 154 of septum 91 is illustrated, only by way of example, in the first quadrant ofthe overlying coordinate axis shown Septum 91 is disposed in access aperture 130 so configured as to produce substantially uniform hydrostatic pressure in the portion of septum 91 subjected to needle penetration
• rim 128 of access aperture 130 imposes upon each point on natural configuration peripheiv 1 ⁇ of septum 91 a force that is radially inwardly directed
• the force F P shown in Figui c ' represents the force of this type applied by rim 128 of access aperture 130 to point P, on natural configuration periphery 154
• each point on natural configuration periphery 154 of septum 91 is displaced radially inwardly Wiih center 164 of septum 91 remaining fixed at the origin ofthe overlying coordinate axis shown, under the influence of force F P , point P, on natural configuration pe
• the strain imposed on an article is equal to the ratio ofthe change in length or width of that article to the onginal length or width, respectively, thereof Therefore, the ratio of first compression distance C x to the maximum extent or length L, of septum 91 in the natural configuration thereof is equal to the ratio of second compression distance C. to width W, of septum 91 in the natural configuration thereof Substituting
• Equation Nos 3 and 4 above into Equation No 2 produces the following relationsm ⁇
• Equation No 2 and Equation No 5 stipulate that the ratio of the combination of the first displacements to the distance between the longitudinal extremes of septum 91 in the natural configuration thereof is equal to the ratio of the combination ofthe second displacements to the distance between said medial extremes of septum 91 in said natural configuration thereof.
• septum 91 An embodiment of a septum, such as septum 91, and a corresponding access aperture 130 with a rim 128 conforming to the above teachings each had elliptical configurations and the following dimensions identified by the corresponding reference characters in Figure 9.
• septum 91 and access aperture 130 were both elliptical and possessed of equivalent aspect ratios and eccentricities, septum 91 and access aperture 130 were geometrically proportional. It should be noted, however, that aperture 130 was not simply smaller in each direction of measure than septum 91 by some fixed increment. This is most readily apparent when the difference in size between septum 91 and access aperture 130 is compared along orthogonal directions of measure taken respectively parallel to longitudinal axis 158 of septum 91 and lateral axis 159 of septum 91. Along longitudinal axis 158, the difference in size between septum 91 and access aperture 130 was the following
• Needle penetration force in any given instance is dependent upon a number >, properties ofthe needle being utilized and the material of the septum being penetrated
• the resistance to needle penetration is proportional to needle size, the internal cohesion of septum material resisting separation at the tip of an advancing needle, and the f ⁇ ctional drag forces that arise between the exterior of the needle and the septum material along the path of needle penetration
• the first step in that process involved the development in computer software of a virtual septum of the size and shape of septum 91.
• the virtual septum was then subdivided mathematically into a large plurality of minute abutting block elements, each defined by six (6) flat faces intersecting in eight (8) linear edges that each terminate between a pair of eight (8) corners.
• the block elements provided the best tradeoff between numerical accuracy and computational efficiency in conducting a finite element analysis of the behavior of the overall structure ofthe virtual septum under externally imposed forces. Care was taken in planning the block elements to avoid the creation of extremely irregular shapes.
• FIG. 10 This approach to the study conducted is illustrated in Figure 10
• a quadrant of a virtual septum 149 is illustrated overlain by a finite element mesh grid that resulted from the mathematical subdivision of virtual septum 149 into a plurality of block elements 150.
• a subset 151 of adjacent block elements 150 is shown displaced out or " the finite element mesh grid, above outer face 140 of septum body 136 of virtual septum 149 near boundary 145 of needle target dome 144.
• a single block structure 150a is shown displaced laterally from the position thereof in subset 151 .
• virtual septum 149 included no reinforcing plug 146 ofthe type illustrated in
• the material response parameters ofthe silicone material of septum 1 were then determined empirically and fitted by a non-linear regression process to an appropriate mathematical representation.
• This mathematical representation of the material response parameters of the material of septum 91 were then added to the software depicting virtual septum 149 A condition of incompressible material behavior was imposed on the material of virtual septum 149 by the computer software
• Hydrostatic pressure contour lines 152 depicting the hydrostatic pressure conditions in virtual septum 149 are drawn on the exterior of virtual septum 149
• the ranges of hydrostatic pressure between each of hydrostatic pressure contour lines 152 are also labeled in Figure 1 1
• the deformation in virtual septum 149 produced by the application of the radially inwardly directed strain is most apparent in Figure 1 1 along inner face 142a near periphery 138
• Inner face 142a can be seen to bulge axially outwardly from the planar configuration of inner face 142a illustrated in the natural configuration of virtual septum 149 in Figure 10
• hydrostatic pressure in the needle penetration region of virtual septum 149 is relatively uniform, being in a range from about 10 pounds per square inch to about 26 pounds per square inch
• Hydrostatic pressure gradient patterns ofthe type shown in Figure 1 1 correspond to conditions of relatively uniform internal stress throughout the entire needle penetration region of an installed septum Consequently, the needle retention force exerted upon the tip of a needle, such as needle 26 of hypodermic syringe 28. that penetrates septum 91 is substantially the same for any point in the cross section of septum 91 at which that penetration is effected.
• the needle penetration force resisting the penetration of septum 91 by the tip of a needle, such as needle 26 of hypodermic syringe 28 is also the same for any point on the cross section of septum 1 at which that penetration is attempted to be effected. This is a most efficacious consequence, and one not previously obtainable in any systematic manner in an installed septum that was not circular.
• clamp means are provided for urging outer face 140 and inner face 142 of septum body 136 toward each other at periphery 138 thereof.
• distance D between bearing surface 102 on retention lips 98 and support shoulder 120 is smaller than the peripheral thickness T p shown in Figure 7 between inner face 142 and outer face 140 of septum body 136 at periphery 138 of septum 91. Accordingly, when septum 91 is disposed in access aperture 130 in housing 40, peripherv 1 8 of septum 91 is axially narrowed between septum retention lip 98 and septum support shouldei 1 0
• Hydrostatic pressure contour lines 152 depicting the hydrostatic pressure conditions in virtual septum 149 are drawn on thc j exterior of virtual septum 149.
• the ranges of hydrostatic pressure between each of hydrostatic pressure contour lines 152 are also labeled in Figure 13.
• Accentuated deformation of virtual septum 149 relative to that observed in Figure 1 1 is seen in
• Figure 12 resulting from the application of the axial strain. This distortion is most apparent in Figure 12 along inner face 142a near periphery 138.
• the combination of this degree of axial strain with the radially inwardly directed strain imposed on virtual septum 149 and illustrated in Figure 12 produced relatively uniform hydrostatic pressure in the needle penetration region of virtual septum 149
• the hydrostatic pressure in the needle penetration region of virtual septum 149 as illustrated in Figure 12 is largely in a desirable range of from about 18 pounds per square inch to about 30 pounds per square inch Also acceptable would hi' hydrostatic pressure in a range from about 10 pounds per square inch to a i ar.gr .u " about 46 pounds per square inch Ultimately, a range of from about 5 pounds per square inch to about 56 pounds per square inch is also appropriate
• needle retention force in a range of from about 0 5 pounds to about 1 5 pounds is also acceptable Needle retention force in a range from about 0 35 pounds to about 2 5 is somewhat less desirable, but even needle retention force in a range from about 0 2 pounds to about 3 5 pounds will suffice in many circumstances
• Figure 13 portrays the effect on the profile of septum 91 of this axial defo imati n in combination with the radially inwardly directed movement of periphery 1 1 of septum 91 produced by housing 40 when septum 91 is installed in access aperture 130
• a natural configuration profile 160 of septum 91 in the natural configuration thereof is depicted in phantom
• This depiction corresponds to the profile of septum 91 shown in Figure 7
• Superimposed on natural configuration profile 160 is an installed configuration profile 162 in solid line of septum 91 in the installed configuration thereof
• This depiction corresponds to the profile of septum 91 shown in Figure 8
• Natural configuration profile 160 and installed configuration profile 162 are superimposed on common central axis A c of septum 91 introduced previously in Figure 3
• a first of these axially directed forces is F 98 , which is imposed on outer face 140 of septum body 136 at periphery 138 of septum 91 by septum retention lip 98.
• the other of the opposed axially directed forces is force F 120 , which is imposed in a direction opposite to that of force F 98 on inner face 142 of septum body 136 at periphery 138 of septum 91 by septum support shoulder 120.
• the overall levels of hydrostatic pressure within the material of septum 91 should be in a broad range from about 5 pounds per square inch to about 50 pounds per square inch. More preferably, however, the hydrostatic ressure in septum 91 in the installed condition thereof should be in a range from about 1 pounds per square inch to about 40 pounds per square inch. A range from about 1 5 pounds per square inch to about 30 pounds per square inch is most preferred.
• Clamp means may optionally also include first gripping ridge 104 on cap 42 of housing 40 and second gripping ridge 122 on base 44 of housing 40.
• first gripping ridge 104 and second gripping ridge 122 axially displace toward each other outer face 140 and inner face 142 of periphery 138 of septum 91, the volume of septum material thusly urged inwardly is relatively small when compared with that resulting from force F 128 applied by rim 128 of access aperture 130, force F 98 applied by septum retention lip 98, and force F, ( , applied by septum support shoulder 120.
• First gripping ridge 104 and second gripping ridge 122 therefor function primarily to retain periphery 138 of septum 91 securely in access aperture 130 in the installed configuration thereof. Doing so markedly prevents buckling or movement of septum 91 in access aperture 130 in reaction to the forces depicted in Figure 13.
• vascular access port 1 an acceptable elongated vascular access port, such as vascular access port 1 8, affords for wide variation in and among the parameters of the septuu utilized therewith. These septum parameters can be altered substantially at will towai ⁇ the goal of producing in a single elongated access port one or more optimum characteristics in the installed configuration ofthe septum.
• septum 91 For example, as the central thickness T c of septum 91 increases, characteristics like needle sealing, needle penetration, and needle retention in septum 91 correspondingly increase. On the other hand, it may be desirable to minimize the size or thickness of septum 91 in order to reduce the overall size ofthe vascular access port in which septum 91 is to be installed. Thus, compromise is required among the goals of optimum septum characteristics in the installed septum and the size of a vascular access port, even if constructed according to the teachings of the present invention uch tradeoffs are common in designing a vascular access port suitable for a specific specialized use.
• FIG. 1 Another example may provide further illumination. If central thickness T cf septum 91 decreases, and if it is desired nonetheless to maintain some predetermined level of septum characteristics in the installed septum, then radially inwardly directed force F 128 imposed on periphery 138 of septum 91 in the installed configuration by rim 128 can be increased. If septum 91 is extremely thin, however, the radially inwardly directed force F 128 needed to maintain predetermined septum characteristics may be so great as to preclude the positioning of septum 91 in access aperture 130 manually during the assembly of vascular access port 18. The additional manufacturing cost of doing so by machine may outweigh the advantage of a very thin septum in the application envisioned.
• a septum such as septum 91
• support means for preventing buckling in the installed configuration of the septum
• needle tai et dome 144 is integrally formed with septum 91 on outer face 140 of septum body 1 ?
• reinforcing plug 146 is integrally formed with septum 91 on inner face 142 of septum body 136
• Each of needle target dome 144 and reinforcing plug 146, respectively, increases the thickness of septum body 136 in the vicinity of center 164 of septum 91 This in turn prevents buckling or dimpling in septum 91, but does so without increasing the peripheral thickness T of septum 91
• This arrangement permits the effective thickness of septum 91 to be enhanced without correspondingly increasing the size of vascular access port 18.
• needle target dome 144 and reinforcing dome 146 may be varied for different specific applications.
• the design of these structures interacts closely in arriving at any desired objective with the overall size of septum 91 in the plane P thereof and the amount of radially inwardly directed force F 12 , intended to be applied in installing septum 91
• An additional parameter that can be adjusted to vary the degree of hydrostatic pressure in the installed configuration of septum 91 is the degree of the mutually oppositely directed axial displacement effected in outer face 140 and inner face 142 at periphery 138 of septum body 136
• the central thickness T c of septum 9 ! or the radially inwardly directed force F 128 imposed on septum 91 may to an extent be compensatingly decreased.
• vascular access ports can be designed in which the characteristics of the septum installed therein are achieved at will by varying independently or in combination the thickness of the septum, the degree of radially inwardly directed forces imposed on the septum, or the extent ofthe axial compression of the periphery of the septum effected to achieve installation It is contemplated, for example, that resort may be made toward such ends to the use of a septum retention lip 98 and septum support shoulder 120 having a nonuniform distance D therebetween This can be attained by altering the separation between septum retention lip 98 and septum support shoulder 120 in selected regions about access aperture 130.
• Desirable patterns of uniform hydrostatic pressure in the installed configuration of a septum can be produced in a variety of configurations of elongated septums
• FIG. 14 depicted in Figure 14 in plan view is a first family of elliptical septums 168, 170, and 172 which has been superimposed on a single coordinate axis
• Figure 14 includes an X-axis that is coincident with the common longitudinal axis 174 of the first family of septums and a Y-axis that is coincident with the common lateral axis 176 of the first family of septums.
• the origin ofthe coordinate axis is positioned at common center 164 of the first family of septums.
• Septums 168, 170, and 172 share a common width B measured along latei ai axis 176, but vary among each other in length as measured along common longitudinal axis 174 thereof.
• Septum 172 with the greatest length A has an aspect ratio and an eccentricity that are greater than those of either of septum 168 or septum 170
• septum 168 with the smallest length A has an aspect ratio and an eccentricity that are less than those of either septum 170 or septum 172
• FIG. 1 A second family of elliptical septums 178, 180 and 182 is depicted in Figure 1 .
• the second family of septums has been superimposed on a coordinate axis having the origin thereof positioned at common center 164 of the second family of septums.
• the coordinate axis of Figure 15 includes an X-axis that is coincident with the common longitudinal axis 183 ofthe second family of septums and a Y-axis that is coincident with the common lateral axis 184 of the second family of septums
• Septums 178, 180 and 182 share a common maximum extent, or length A. measured along common longitudinal axis 183, but the width of each respective septum measured along lateral axis 184 varies throughout the second family of septums. As septum 182 has the largest width B 3 , septum 182 has an aspect ratio and an eccentricity that are smaller than those associated with either septum 180 or septum 178. Correspondingly, as septum 178 has the smallest width B, septum 178 has an aspect ratio and an eccentricity that are larger than those associated with either septum 180 or septum 182.
• Figure 15 are examples of a very particular category of the elongated septums that incorporate teachings of the present invention.
• the septums illustrated in Figures 14 and 15 are referred to as "truly elliptical.”
• a truly elliptical septum has an outer periphery that is defined by the following single continuous mathematical relationship:
• Elongated septums within the scope of the present invention include many types of septums other than just septums that are truly elliptical.
• a truly elliptical septum 186 upon which has been superimposed an oval septum 187 having a periphery 188 that is at several locations almost congruent with the periphery of truly elliptical septum 186
• Periphery 188 of oval septum 187 comprises respective semicircular extreme ends 189 tangentially interconnected by a pair of straight sides 190
• oval septum 187 and truly elliptical septum 186 have equal lengths A
• the width B 187 of oval septum 187 is less than the width B 186 of truly elliptical septum 186 This results in a higher aspect ratio and eccentricity in truly elliptical septum 186 than in oval septum 187.
• both of the septums illustrated in Figure 16 are elongated within the scope of the present invention, and oval septum 187, while not being truly elliptical, is in several design respects substantially elliptical
• FIG. 17 illustrated in Figure 17 in dashed line is a truly elliptical septum 200 superimposed upon an elongated septum 202 having, mathematically, a relatively complex periphery 204
• both truly elliptical septum 200 and elongated septum 202 have in turn been superimposed upon a coordinate axis having the origin thereof located at common center 164 ofthe sepiums depicted
• the coordinate axis of Figure 17 includes an X-axis that coincides with the longitudinal axis 206 of both true elliptical septum 200 and elongated septum 202 and a Y-axis that coincides with the common lateral axis 208 of each.
• Longitudinal axis 206 intersects periphery 204 of elongated septum 202 at a fust extreme end portion 210 and an opposed second extreme end portion 212
• First extreme end portion 210 and second extreme end portion 212 are each symmetrical aboiu common longitudinal axis 206 In the embodiment illustrated, first extreme end portion 210 and second extreme end portion 212 are also mirror images of each other
• First extreme end portion 210 intersects second extreme end portion 212 nontangentiallv at a first vertex 218 and a second vertex 220, each of which is disposed on common lateral axis 208.
• first extreme end portion 210 and of second extreme end portion 212 are each substantially parabolic. Accordingly, the point at which the periphery of first extreme end portion 210 intersects longitudinal axis 206 is referred to as the vertex of first extreme end portion 210 Similarly, the point at which second extreme end portion 212 intersects longitudinal axis 206 is referred to as the vertex of second extreme end portion 212.
• first extreme end portion 210 and the periphery of second extreme end portion 212 each have a corresponding associated focal point that is disposed interior of periphery 204 of elongated septum 202 These are focal point 214 corresponding to first extreme end portion 210 and focal point 216 corresponding to second extreme end portion 212.
• a parabolic end portion of a septum has an outer periphery that is defined by the following mathematical relationship:
• septum 202 In view of the distinctive mathematical shape of extreme end portion 210 and extreme end portion 212, septum 202 will be referred to hereinafter as "parabolic ended” septum 202. It should be noted that parabolic-ended septum 202 and tnily elliptical septum 200 each have identical lengths A and widths B. Therefore, the aspect ratio and eccentricity of each are equal, respectively.
• parabolic-ended septum 202 has a slightly smaller surface area than that of truly elliptical septum 200 and would accordingly present a smaller needle target area than would truly elliptical septum 200, despite the identical length A and width B of each.
• each ofthe septums depicted in Figure 17 might advantageously be utilized in the design of an elongated vascular access port for a specific intended use. Nonetheless, both of these septums illustrated in Figure 17 are elongated within the scope of the present invention, and parabolic-ended septum 202 while not being truly elliptical, is in several design respects substantially elliptical.
• Figure 18 presents yet another such comparison
• a truly elliptical septum 230 is shown in dashed line superimposed upon an elongated septum 2 2 with a periphery that includes a plurality of straight sides 236 that intersect each other at vertices 238.
• Straight sides 236 need not be equal in length or in any way symmetrically disposed, although the latter characteristic is apparent in elongated septum 232.
• straight sides 236 be tangential to any truly elliptical septum, such as truly elliptical septum 230, as is the case for straight sides 236 shown in Figure 18.
• Alternative polygonal configurations utilizing fewer or more straight sides than the eight (8) such sides illustrated in Figure 18 would also be appropriate.
• septum 232 In view of the shape of the periphery of elongated septum 232, elongu; A. septum 232 will be referred to hereinafter as "polygonal" septum 232 It shoui'. ; .e noted that truly elliptical septum 230 and polygonal septum 232 each have identical length A and width B. Therefore, the aspect ratio and the eccentricity of each are equal, respectively. Polygonal septum 232 has a slightly larger surface area than that of truly elliptical septum 230 and accordingly might be expected to present a larger needle target area than would truly elliptical septum 230, despite the identical length A and width B of each.
• Polygonal septum 232 is presented in order to demonstrate that the teachings of the present invention contemplate the use of elongated septums in a diverse range of shapes. These shapes may be considered substantially elliptical, but if not so considered, septums of such shapes can yet be installed in the housing of a vascular access port, if the access aperture in the housing thereof is designed according to the above teachings of the present invention for producing uniform stress characteristics in the installed configuration of the septum. By so doing, numerous vascular access ports can be provided that are elongated and streamlined in shape, and therefore susceptible to successful implantation in small tissue areas, such as in the extremities of an adult patient or in the body of an infant or a small child.
• Such elongated vascular access ports need not, however, suffer any reduction in needle target area in the septum utilized therewith or exhibit undesirable irregularities in needle sealing, needle retention, or needle penetration characteristics. Septums with needle target domes with eccentricities of 0.81 , 0 90, or higher can be incorporated into access devices.
• the insights and discoveries disclosed above free the design of future vascular access ports from the limitations and disadvantages brought about by an exclusive reliance upon septums that are round in cross section.

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• 1998
  • 1998-01-12 US US09/005,608 patent/US6213973B1/en not_active Expired - Lifetime
• 1999
  • 1999-01-12 EP EP99903068A patent/EP1047473A1/en not_active Withdrawn
  • 1999-01-12 JP JP2000527305A patent/JP2002500076A/ja active Pending
  • 1999-01-12 AU AU23180/99A patent/AU745940B2/en not_active Ceased
  • 1999-01-12 CA CA002318089A patent/CA2318089A1/en not_active Abandoned
  • 1999-01-12 WO PCT/US1999/000700 patent/WO1999034859A1/en not_active Application Discontinuation

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