Note: Descriptions are shown in the official language in which they were submitted.
1~93~tl0
This invention relates to devices which operate with
needles to transfer fluids to or from a prosthesis and ~ore
particularly to a septum with a novel needle stop
arrangement that prevents a needle from penetrating a fluid
transfer structure after the needle has accessed a fluid
chamber of the septum.
As used herein the term ~fluid transfer structure~
relates to external fluid flow structure communicating wlth
the fluid chamber of a septum.
Prosthetic devices implanted in the body to re~tore
shapes and contours that have been surgically altered or
accidentally deformed usually reguire infusions of fluid to
restore proper pocket tension or to modify the shape or
contour of the prosthesis. ~owever it is normally not
feasible to make direct acces~ with a prosthesis for fluid
infusions or fluid withdrawals due to the remote location of
many prostheses and due to possible leakage problems that
may develop if a prosthesis is penetrated by a needle.
. ~
3660
Septums have thus become a well known vehicle for
transferring fluid to a prosthesis through a fluid transfer
structure and alternatively can be used to drain unwanted
fluids from certain areas of the body. A septum, which i8
S generally implanted near a prosthesis, usually includes a
fluid chamber sealed by a needle penetrable seal member.
Fluid is infused into or withdrawn from the fluid chamber by
a hypodermic needle that accesses the fluid chamber through
the needle penetrable seal member. The fluid transfer
structure normally communicates with the fluid chamber and
lnterconnects with the pro~thesls.
Once a needle has penetrated the fluid chamber of
a septum it i5 necessary to ~top further movement of the
needle in the septum to prevent the needle from passing
completely out of the fluld chamber. It is thus well known
to provlde a needle stop member in a septum, usually at the
base of the fluid chamber. The needle 8top member is
~enerally constructed of a needle impermeable material to
prevent further movement of a needle out of the fluld
chamber.
The fluid transfer structure which extends from the
fluid chamber i8 usually formed of a relatlvely soft
flexlble material that does not reslst penetration by a
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needle. Since the septum is normally lmplanted below the
skin it i8 difficult to predetermine the path of the needle
whlch accesses the fluid chamber. Thus the area of the
septum where the fluid transfer structure joins the fluid
chamber is vulnerable to penetrations by a needle if such
needle is inadvertantly oriented in a direction toward the
fluid transfer structure during a fluid infusion or fluid
withdrawal operation.
If a needle penetrates the fluid transfer structure
after accessing the fluid chamber, the fluid transfer
operation cannot be completed. Furthermore it may be
difficult to detect when a needle has penetrated or passed
through the fluld transfer ~tructure, since such structure
i~ implanted below the surface of the skin. ~nder these
clrcumstances the person administering a fluid transfer
operation is often not aware that fluid may be bypassing the
fluid chamber.
It $8 thus desirable to provide a septum having a
needle stop structure that prevent~ a needle in a fluid
chamber from penetrating the fluid transfer structure and
does not obstruct the flow of fluid into the fluid transfer
structure.
3660
osJ~cTs AND~ ~O~LC~J~ e ~
Among the several ob~ects of the inventlon may be
noted the provi~ion of a novel septum, a novel septum having
a needle stop structure at the fluid chamber where a fluid
transfer structure joins the fluid chamber, a novel septum
having a needle stop structure that prevents movement of
a needle from a fluid chamber into a corresponding fluid
transfer structure yet does not obstruct flow from the fluid
chamber into the fluid transfer structure, a novel septum
havlng a needle stop structure that prevents a needle from
passing out of the fluid chamber and also prevents a needle
from passlng into the fluld transfer structure, and a novel
method of making a septum.
Other ob~ects and features of the invention will be
in part apparent and in part polnted out hereafter.
The septum, in accordance wlth one embodiment of the
invention, includes a mean~ for accumulating fluid such as a
flu1d or fill chamber that is sealed by a needle penetrable
-seal member. The fill chamber also includes a port for
inlet or outlet of fluid. The needle penetrable seal member
perm~ts outside access to the fluid chamber upon penetratlon
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by a needle. Fluid flow means extend from the port of the
flul~a chambo~ and inolude a flow ~efl~in~ t~uotu~e ~o
establish a flow path to or from the fluid chamber. A
needle stop means ls provided in the fluid chamber in the
vicinity of the port where the fluid flow means communlcates
with the fluid chamber. The needle stop means prevent~ a
needle that accesses the fluid chamber through the seallng
means from penetrating the flow defining structure in the
vicinity of the port.
In one embodiment of the invention, the needle stop
means comprises a impermeable flap member that overhangs the
fluid flow port within the fluid chamber and thus prevents a
needle from entering the flow path of the fIow def~ning
structure. Since the needle iB prevented from enterlng the
flow path of the fluid it cannot penetrate the flow defining
~tructure.
If desired, the needle stop overhanq can be formed
as a portion of a needle stop member that lines the fluid
chamber.
In another embodiment of the lnvention the needle
stop structure which prevents a needle that accesses the
~luid chamber from moving out of the fluid chamber into the
flow defining structure includes an impermeable nozzle-like
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annular collar that extends into the fluld chamber from the
port. The nozzle communicates with the flow defining
structure and has a predetermlned size and extent which
prevents a needle that has accessed the fluid chamber from
S passing out of the f}uid chamber through the port. The
nozzle-like annular collar thus protects the flow defining
structure from penetration by the needle.
In still another embodiment of the invention, an
impermeable nozzle-like annular collar extends from the port
of the fluld chamber into the fluid flow means, forming a
protective liner for the flow defining structure. Thus,
even if a needle which accesses the fluid chamber i~
dlrected toward the port, the nozzle prevents the needle
from penetrating the flow deflning structure.
flow means.
In a further embodiment o the invention, an
impermeable U-shaped nozzle extends from the port of the
fluld chamber into the fluid flow means. An openlng
provided in the ~-shaped nozzle permits the port of the
fluid chamber to communicate with the fluld flow means. The
nozzle openlng is a predetermlned size and dlstance from the
port to assure that a needle accessing the fluld chamber
cannot pass into or penetrate the flow deflning structure.
1~936~iO
In yet another embodiment of the inventlon, an
impermeable conduit extends from the port of the fluid
chamber into the chamber ~pace. A ~urface of the conduit
which is inaccessible to a needle is provided with openings
that communicate with the fluid chamber port. Under thls
arrangement, the fluid chamber port is shielded by the
conduit such that a needle which has accessed the fluid
chamber cannot pass through the fluid port to the flow
deflning structure of the fluid flow means.
In all embodiments of the invention, the needle stop
structure can be formed integral with a needle stop member
that line~ the interior of the fluid chamber.
The needle stop structure of the present invention
thus provides assurance that a needle which accesses a fluid
chamber will not penetrate the fluid transfer structure or
become embedded in structure beyond the fluid chamber.
The invention accordlngly comprises the
con~tructions and the method herelnafter described, the
scope of the invention being indicated in the claims.
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= s~
In the accompanying drawings, in wh~ ch several
embodiments of the invention are illustrated,
Fig. l is a simplified pictorlal view of a septum
incorporating one embodiment of the invention being used for
infu~lng a prosthesis with a hypodermic needle;
Fig. 2 i~ a sect~onal view thereoft
Fig. 3 is a top plan vlew thereof, partly broken to
clarify ~ome structural detailst
Flg. 4 is an exploded perspect1ve view thereoft
F1gs. 5-8 are sectional views of other embod~ments
of the lnvention~ and,
Fig. 9 18 a sectional view takén on the line 9-9 of
Fig. 8.
lS Corresponding reference characters indicate
corresponding parts throughout the several views of the
draw1ngs.
DETAIL~P ~
A septum incorporating one embodiment of the
invention is generally indlcated by the reference number 10.
The septum lO comprlses a generally cup-shaped needle stop
1 ~ ~ 3 ~ 0
member 12 having a base 14 which can be of spherical
conl:our.
The needle ~top member 12 i~ preferably formed of
stainless steel and has a mouth portion defined by a
perlpheral wall section 16. An inclined support ~urface 18
extends from the wall section 16, and a depending wall
section 20 extends from the inclined support surface 18 to
the base 14.
A fluid transfer port or opening 22 is provided in
the wall section 20. A flap-like needle stop section 24,
which can be formed from a portlon of the wall section 20,
extends over the fluid transfer opening 22.
A jacket sectlon 26 preferably formed of a silicone
elaBtomer $B molded or otherwise provided in leak-tlght
arrangement around the needle stop member 12. A fluid
transfer tube 28, which can be integrally molded with the
jacket section 26, extends from the ~acket section 26 to a
prosthesis 30, partially shown in dotted outline ln Fig. 1.
A fluid passage 32 extends from the fluid transfer opening
22 through the ~acket ~ectlon 26 and the tube 28. The tube
28 and a portlon of the ~acket sectlon 26 thus const~tute
the flow defining structure of the fluid passage 32.
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A dome-shaped needle penetrable seal member 34,
preferably formed of a silicone elastomer and havlng a
reduced perlpheral section 36 ls disposed on the incllned
support surface 18 of the needle ~top member 12. A clamping
ring 38, whlch is threaded, staked, press-fit or otherwlse
secured to the wall ~ectlon 16, presses the edge portion 36
of the seal member 34 against the support surface 18 to
accomplish a leak-tight seal. The reduced perlpheral edge
portion 36 of the seal member 34 thus function~ a~ a sealing
gasket.
Under this arrangement, the space encompassed by
the needle stop member 12 and enclosed by the seal member 34
constltutes a fluid chamber or fill chamber 40 (Fig. 2) of
the septum 10.
In usir.g the septum 10, an implantation thereof is
made under the surface of the skin (not shown) with the
floid tran~fer tube 28 directed toward the prosthesis 30.
The septum 10 can be located before a fluid infusion or
fluid withdrawal operation by palpating the skin whlch
~0 cover~ the area of the septum 10.
A syringe 42 containlng a desired fluid is directed
toward the septum 10 to permit the needle 44 to penetrate
the aeal member 34.
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Once the needle 44 accesse~ the fluid chamber 40,
therle can be no further needle penetration beyond the fluid
chamlber. For example, the wall section 20 of the needle
stop member 12 wlll prevent the needle 44 from penetrating
the jacket section 26 from the fluid chamber 40.
Furthermore, the base 14 of the needle stop member 12 will
likewise prevent the needle from penetrating the jacket
after accessing the fluid chamber 40.
An area of previous vulnerability to needle
penetrations had been the fluid transfer opening 22. This
area i6 no longer ~ubject to needle penetrations due to the
presence of the needle stop flap 2~ which projects over the
fluid transfer opening 22. Thus, even if the needle 44 is
inadvertently dlrected toward the fluid transfer opening 22
as shown in ~ig. 2, the needle stop flap 24 will deflect or
otherwi~e prevent the needle 44 from entering the opening 22.
Under this arrangement, fluld infused into the
chamber 40 by the syringe 42 18 not obstructed from passing
through the opening 22 lnto the fluid passage 32. The
septum 10 is capable of resisting needle penetrations beyond
the fluid chamber 40 even when the needle 44 is inadvertently
directed toward the fluid transfer opening 22. The
integrlty of the flow defining structure, which includes
the portion of the jacket 26 surrounding the passageway 32
and the fluid transfer tube 28, is thus maintained.
1;~93660
Another embodiment of the septum i8 generally
indlcated by the reference number 50 in Fig. 5. The septum
50 includes a needle stop member 52 having a ~pherical base
54, a peripheral ~ection 56 and an inclined support ~urface
58 identical to the corresponding structure of the needle
stop member 12.
The needle stop member 52 further includes a
depending wall section 60 extending from the inclined
~upport surface 58 to the ba~e 54. The wall section 60
lncludes an lmpermeable annular collar formation such as a
nozzle 62 pro~ecting lnto a fill chamber 64 of the septum 50
from a port 66. A nozzle opening 68 is defined at the end
of the nozzle 62 within the fill chamber 64.
The septum 50 further includes a needle permeable
seal member 70, a clampinq ring 71, a ~acket section 72 and -
a fluid transfer tube 74 ldentical to the seal member 34
clamping ring 38, ~acket section 26 and fl~id transfer tube
28 of the septum 10.
The septum 50 is used in a manner similar to that
previously described for the septum 10. It wlll be noted
that a needle (not shown) directed toward the port 66 cannot
penetrate the nozzle 62. Furthermore, the diameter and
extent of the nozzle 62 into the fill chamber 64 are
i ~ ~ 3 ~ 6 ~
pre~determined such that even if a,needle were directed
toward the nozzle opening 68, it could not pass through the
port 68 whlch iB ~urrounded by the jacket section 72.
Under this arrangement, the nozzle 62 effectively
prevents a needle from penetrating the ~acket section 72 and
the fluid transfer tube 74. The fluid tran~fer ~tructure of
the septum 50 i8 thu~ protected fsom penetration by a needlè
that has acces6ed the fill chamber 64.
A further embodiment of the septum i8 generally
indicated by the reference number 80 in Fig. 6. The septum
80 has a needle stop member 82 which lines a fill chamber 84
having a port 86. An impermeable annular collar formation
such as a nozzle 88 extends from the port 86 outwardly of
the fill chamber 84 into the passageway 32 of a ~acket
section 90 and a fluid transfer tube 92. The nozzle 88 has
an opening 94 within the passageway 32. In all other
respects, the needle stop member 82 18 similar to the needle
stop member 52.
- The ~eptum 80 further includes a needle penetrable
seal member 96 and a clamping rlng 98 ldentical to the seal
member 34 and clamping ring 38 of the septum 10.
The septum 80 is used in a manner similar to that
previously described for the septum 10. The nozzle 88 ha~ a
13
1~36f~0
predetermined diameter and extent into the fluid transfer
tube 92 that effectively prevents a needle tnot shown) from
extending beyond the openlng 94 even if the needle has been
lnadvertently directed toward the fluid port 86. The flow
defining structure 90 and 92 of the 6eptum 80 ~ 8 thus
protected from penetrations by a needle that ha6 acces~ed
the fill chamber 84.
Another embodiment of the septum is generally
indicated by the reference number 100 in Fig. 7. The 6eptum
100 has a needle stop member 102 which lines a fill chamber
104 having a port 106. An impermeable annular collar
formation, such as a nozzle 108, extendg from the port 106
outwardly of the fill chamber 104 lnto the passageway 32 of
a ~acket sectlon 110 and a fluld transfer tube 112. The
nozzle 108 is U-shaped in cross-section and includes an
opening 114 that forms a continua,tion,of the pas~ageway 32.
In all other respects the needle stop member 102 is similar
to the needle stop member 52.
The septum 100 al60 includes a needle penetrable
~eal member 116 and a clampin~ rlng 118 identical to the
seal member 34 and the clamping ring 38 of the septum 10.
The septum 100 is used in a manner similar to that
described for the septum 10. The nozzle 108 has A
6~iO
preldetermined diameter and extent to render the openlng 114
virtually inaccessable to a needle ~not shown) even though
such needle might be inadvertently directed toward the port
106. Consequently the flow defining structure 110 and 112
of the septum 100 is out of range of a needle that has
accessed the fill chamber 104. The flow defining structure
110 and 112 is thu~ protected from needle penetrations.
A further embodiment of the 6eptum is qenerally
indicated by the reference number 120 in Fig. 8. The septum
120 has a needle stop member 122 which lines a fill chamber
124 having a port 126. A conduit 128 extends from the 1?ort
126 across the fill chamber 124.
A passageway 130 in the condult 128 communicates
through the port 126 wlth a passageway 132 of a ~acket 134
and a conduit 136. The condu~t 128 terminates at an end 138
that 18 cut or formed at a predetçrmined angle with respect
to its longitudlnal axis (not shown) and bears agalnst the
needle stop member 122. The passageway 130 thus opens lnto
the flll chamber 124 at the condult end 138. A pl-~rallty of
openings 140 prov$ded in the conduit 130 face a base portlon
142 of the needle stop member 122.
The septum 120 also includes a needle penetrable
~eal member 142 and a clamping ring 146 identical to the
1~3660
seal member 34 and the clamping ring 38 of the septum 10.
The septum 120 i~ used in a manner similar to that
descr~bed for the septum 10. The conduit 128 shieldR the
port 126 from a needle (not shown) that accesses the fill
chamber 124. The opening 140 and the open end portion 138
of the conduit 128 permit communication between the fill
chamber 124 and the pa~sageway~ 130 and 132. Since the
openings 140 of the conduit 128 face the base 142 of the
needle ~top 122, the passageway 130 i~ inaccessible to a
needle ~not ~hown) that enters the fill chamber 124 through
the needle penetrable seal member 144. The port 126 and the
flow defining structure 134 and 136 are likewlse
inacce~sible to a needle and are thus protected from needle
penetration.
It will be apparent that for each embodiment of the
invention, a syringe needle can enter the fill chamber of
the septum at an infinite number of angles and dlrectlon~.
~owever, only a limited range of access angles of the needle
into the fill chamber will direct the needle toward the
fluld transfer openlng.
Thus the potential path of a needle to or beyond the
fill port is either blocked from needle penetration or
reinforced with a protective structure that inhibits or
16
1;~936~0
prevents a needle from penetrating the flow defining
structure that extend~ from the fill port.
Some advantages of the pre~ent invention ev~dent
from the foregoing de~cription include a septum that is
completely protected in the vicinity of the fill port to
prevent a needle from penetrating the fluid transfer
Rtructure that extends from the needle stop member.
Consequently there can be reliabillty that a needle which
has accessed the fill chamber of the ~eptum will not
penetrate the fluid transfer structure.
In vlew of the above, lt will be ~een that the
several ob~ects of the lnvention are achieved and other
advantageous results attained.
As varlous changes can be made in the above
constructlons snd method without departing from the scope of
the lnvention, it is intended that all matter contalned ln
the above descrlption or shown in the accompanylng drawings
shall be interpreted as illustrative and not in a llmltlng
- sense.
