CA1293660C - Septum with a needle stop at the fluid transfer port - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
The septum includes a fill chamber having a port that is reinforced or otherwise protected by a needle stop structure. The needle stop structure prevents a needle that has accessed the fill chamber from penetrating the fluid flow structure that extends from the fill chamber. In one embodiment of the invention, the needle stop structure overhangs the port thereby preventing a needle from entering the port. In a further embodiment of the invention the needle stop structure includes a nozzle-like annular collar which extends from the port into the fill chamber. In another embodiment of the invention, the needle stop structure includes a nozzle-like annular collar that extends from the port into the fluid flow structure. In yet another embodiment of the invention, the needle stop structure includes a cup-shaped structure that extends from the port into the fluid flow structure and has an opening in the fluid flow structure. In still another embodiment of the invention, the needle stop structure includes a conduit that extends from the port across the fill chamber. In all embodiments of the invention the needle stop structure is impermeable to penetrations by a needle and thus protects the fluid transfer structure from penetrations by a needle.

Description

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.

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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 36~0 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.

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 12~36~à0 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 1~93660 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.

1~3660 = 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.

36~0 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 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 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.

Claims (22)

1. A septum for a prosthesis comprising, (a) means for accumulating fluid, including a fluid chamber having a port, (b) needle penetrable sealing means for said fluid chamber for permitting needle access to said fluid chamber upon penetration of said sealing means by said needle, (c) fluid flow means communicating with said fluid chamber for establishing a fluid flow path with said fluid chamber, said fluid flow means including flow defining structure for defining said fluid flow path, and (d) needle stop means including a needle stop portion provided at said port to prevent said needle that accesses said fluid chamber through said sealing means from penetrating said flow defining structure through said port.

2. The septum as claimed in claim 1 wherein said needle stop means includes means for preventing said needle from entering the flow path of said fluid flow means.

3. The septum as claimed in claim 1 wherein said needle stop portion includes a needle stop flap extending over said port.

4. The septum as claimed in claim 3 wherein said needle stop means further includes a needle stop member at predetermined peripheral portions of said fluid chamber for preventing a needle that accesses said fluid chamber through said sealing means from moving out of said fluid chamber at said predetermined peripheral portions.

5. The septum as claimed in claim 4 wherein said needle stop flap is joined to said needle stop member.

6. The septum as claimed in claim 1 wherein said needle stop portion includes an annular collar portion projecting a predetermined distance from said port into said fluid chamber, said annular collar being formed of a material impermeable to needles, and having an opening spaced from said port which communicates with said port.

7. The septum as claimed in claim 6 wherein said needle stop means further includes a needle stop member at predetermined peripheral portions of said fluid chamber for preventing a needle that accesses said fluid chamber through said sealing means from moving out of said fluid chamber at said predetermined peripheral portions.

8. The septum as claimed in claim 7 wherein said annular collar portion is joined to said needle stop member.

9. The septum as claimed in claim 1 wherein said needle stop portion includes an annular collar portion extending a predetermined distance from said port into said fluid flow means, said annular collar portion being formed of a material impermeable to needles, and having an opening spaced from said port which communicates with said port and said fluid flow path.

10. The septum as claimed in claim 9 wherein said needle stop means further includes a needle stop member at predetermined peripheral portions of said fluid chamber for preventing a needle that penetrates said sealing means from moving out of said fluid chamber at said predetermined peripheral portions.

11. The septum as claimed in claim 10 wherein said annular collar portion is joined to said needle stop member.

12. The septum as claimed in claim 1 wherein said needle stop portion includes a cup-shaped portion extending a predetermined distance from said port into said flow defining structure, said cup-shaped portion being formed of a material impermeable to needles, said cup-shaped portion having a mouth at said port and an opening spaced from said port which communicates with said port and said fluid flow path.

13. The septum as claimed in claim 12 wherein said needle stop means further includes a needle stop member at predetermined peripheral portions of said fluid chamber for preventing a needle that penetrates said sealing means from moving out of said fluid chamber at said predetermined peripheral portions.

14. The septum as claimed in claim 1 wherein said needle stop portion includes a conduit extending from said port into said fluid chamber, said conduit being formed of a material impermeable to needles.

15. The septum as claimed in claim 14 wherein said conduit extends across said fluid chamber and includes openings remote from said needle penetrable sealing means such that said openings are inaccessible to a needle penetrating said sealing means.

16. The septum as claimed in claim 15 wherein said needle stop means further includes a needle stop member at predetermined peripheral portions of said fluid chamber for preventing a needle that penetrates said sealing means from moving out of said fluid chamber at said predetermined peripheral portions.

17. The septum as claimed in claim 16 wherein said conduit has a longitudinal axis and a passageway having an open end portion that bears against said needle stop member and makes a predetermined angle with said needle stop member such that said passageway opens into said fluid chamber.

18. A septum for a prosthesis comprising, (a) means for accumulating fluid, including a fluid chamber having a port, (b) needle penetrable sealing means for said fluid chamber for permitting needle access to said fluid chamber upon penetration of said sealing means by said needle, (c) fluid flow means communicating with said fluid chamber for establishing a fluid flow path with said fluid chamber, said fluid flow means including a flow defining structure for defining said fluid flow path, (d) needle stop means at the periphery of said fluid chamber for preventing a needle that accesses said fluid chamber through said sealing means from moving out of said fluid chamber, and (e) said needle stop means including a needle stop portion provided at said port to prevent said needle that accesses said fluid chamber through said sealing means from penetrating said flow defining structure through said port.

19. A method of making a septum comprising, (a) forming a needle stop member in the general shape of a cup with a mouth portion and a wall portion, and providing a port in the wall portion of the needle stop member, (b) establishing a fluid flow path from said fluid chamber with flow defining structure that communicates with the port, (c) sealing the mouth of the needle stop member with a needle penetrable seal member, (d) protecting the flow defining structure in the area of the port from penetration by a needle, by providing a needle impenetrable section at the port that prevents a needle from penetrating the flow defining structure through the port, yet permits fluid to flow through the port.

20. The method of claim 19 wherein the needle impermeable section is formed to extend inside the flow defining structure.

21. The method of claim 20 wherein the needle impermeable section is formed to project inside the fluid chamber as an extension of the port.

22. The method of claim 19 wherein the needle impermeable section is formed to partially extend over the port.