CA2193651C

CA2193651C - Improved self-sealing injection sites and plugs, implantable prosthesis and other devices utilizing same and method of manufacture

Info

Publication number: CA2193651C
Application number: CA002193651A
Authority: CA
Inventors: Timothy B. Petrick
Original assignee: Mentor Corp
Current assignee: Coloplast AS
Priority date: 1994-03-04
Filing date: 1995-03-03
Publication date: 2005-07-26
Anticipated expiration: 2015-03-03
Also published as: US5935362A; DE69529216D1; US5725507A; EP0766573B1; EP0766573A1; CA2193651A1; AU1938395A; DE69529216T2; WO1995023623A1

Abstract

Small compression type injection site in the form of a self-sealing septum-like member that is self-sealing for hypodermic needle punctures and the like and a method of manufacture. Compressive stresses are introduced into a stretched clastomeric rod, whereby the decreased diameter cross section is maintained by placing a wrapping around and about the stretched rod and adhesively sealing it thereto. Sliced cross-sectional pieces of the rod then provide injection sites to be incorporated into the wall of an implantable prosthesis as by bonding or the like.

Description

ri 93651 _1-IMI'ROVI;D SELr-SEALING INJECTION SITES AND PLUGS, IMPLANTAI3LE 1'ROSTIICSIS AND OTIIC?R DIJVICES UTILIZING SAMIJ
AND METhIOD Or IVIANUrACTUR>J ~ .
l3ackstround of the Invention This invention pertains to improved compression type self-sealing injection sites, and more particularly, it relates to a minimum size self-scaling injection sites or seplums featuring self scaling subsequent to puncture by a hypodermic needle or lhc like. The lcrtn "injection sift" as used herein refers to self-scaling systccns and similar bodies of the prior art used as ports and plugs. The injection sites of flit invention have particular appllCalloll lIl llllpl<llltablC prosthetic devices of the type which require filling through the site with a fluid by means of an injection needle or the like.
I~or example, penile prosthesis, mammary prosthesis or tissue expanders devices having remote injection sites and drug delivery systems will make use of the improved injection sites of this invention. This invention was developed for use with a saline filled testicular prosthesis which is described herein. However, the injection sites of this invention can be used in any device requiring a plug or septum.
Injection sites, buttons and other self scaling septums of the prior art using compression to sclC-seal are described in U.S. Patent Nos. 4,428,364;
4,738,657;
4,798,584; 4,840,615; and 5,137,529.
The injection site of U.S. Patent No. 4,428,364 contains multiple layers of fabric reinforced silicone rubber sheets fabricated info a dome shaped wall. Tlic fabric weave within the layers is oriented in different directions. The reinforced silicone sheets are subjected to a swelling agent. The combined effect of the swelling silicone and restraining fabric causes a compressive stress to develop in the wall.
The injection sites described in U.S. Patent Nos. 4,738,657, 4,798,584, and 4,840,615 arc all generally similar. They use various bending and inverting.
techniques to create compressive stresses on the inside surface of the outer wall of the site. Compression is developed by (1) bending a sheet of silicone into a domed shape;

(2) inverting a previously formed silicone dome; and (3) cuffing the wall of a silicone tube then rolling it into a flat sheet.

. 2193651 Compression is atlaincd in U.S. Patent No. 5,137,529 through interference fits. All Cl:lSlOlttcl'IC SC(7t11111 Corlned with the outer housing is compressed by a rigid bast member.
The prior art discussed about all develop enough compression to self-seal when subjected to hypodermic needle punctures. However, the prior art depends on other rigid members t0 IllalIltalIl COtIlprcSSloll.
The art referred to and/or described above is not intended to constitute all adnllSSlot1 that any patent, publication or other information referred to herein is "prior art" with respect to this invention. In addition, this section should not be lU construed to mean that a starch has been made or that no other pertinent information as defined in 37 C.I~.R. 51.56(x) exists.
S(llllltl:ll'Y ()~ tllC IIIVCIlt1()Il ~l~IltS 111VCI1tIUIl provides new and improved colnprcssion type self-sealing injection sifts and a method of IllallufaCtUrtllg such sites. Generally, an injection site is provided in which energy has been stored by means of a wrapping associated with the sift body. Specifically in one embodiment of this new site, compressive stresses are induced in an elastic elastomeric rod such as silicone by stretching the rod, causing its diameter to decrease. A strand, preferably a continuous one, such as fiberglass filament, is then wound around the stretched rod. The strand maybe passed through an adhesive prior to the winding step or exposed to it aftCr wIIIdIIIg. ~rllC
wI'117p1I1g associated wish the rod stores the energy produced by stretching of the rod when the tension is released. Individual injection sites are formed by~cutting or slicing the rod lransverscly to desired lengths after the adhesive cures.
More specifically, the present Invention provides an increased density injection site in which x decreased cross section is maintained by an adherent wrapping about a stretched elastomeric rod which is subsequently cut into appropriate cross-.
sectional lengths to provide discrete injection sites. One such site may then be bonded into an orifice in the wall of an implantable prosthesis for sealing the contents thereof alld to act as a self scaling injection site or septum.
Consequently, the present invention provides plugs and compression type injection sites that are self sealing to hypodermic needle punctures and the like and a method of manufacturing same. The compressive stresses are induced into an '- -3_ ~ i X365 ~
elastomcric rod, such as an elastic silicone rod, by stretching the rod, causing the diameter to decrease. A wrapping such as a fiberglass strand 1I11pI'CgnatCd with silicone adhesive, is wound around the stretched rod and allowed to cure.r A plurality of It11I111T1u111 SIZC InJCC110I1 S1LCS Calt be forincd from the rod by cutting it to desired lengths after the adhesive has cured and the tension has been released from the rod.
'rhe injection sites of the present invention may be used, for exalnple, for introduction of a physiologically safe fluid, such as saline into a testicular prosthesis. It also has uses in other prosthetic devices. For example, penile prosthesis, tllaIlllllal'y pl'OStIICSIS, and tissue expanders and so forth as already mentioned.
/lccordinb to a preferred cmbodilncnt of the present invention, there is provided a COlllpl'CSSiOtI type injection site having a central elastic silicone member in flit form of a slug held in an elongated and compressed form by a fiberglass filament wound about and adhered to the outer circumferential surface of L11C CCIItI'al elastic silicone slug.
Onc significant aspect and feature of the present invention is that the IIIJeCtI0I1 Sites have a precompressed central member bound by a wrapping or the like.
An additional significant aspect and feature of the present invention is that the injection sites have minimum size, both diameter and thickness, and minimum palpability or awareness when carried by an implanted prosthesis.
Yet another significant aspect and feature of the present invention is that the injection site i7exibility contributes to the continuity of the prosthesis in which it is carried.
Also, the wrapping arrangement about the core presents a good bonding surface for mounting the injection sites of this invention into the device whicft is to make use of them.
'the precomprcssed arrangetncnt of these injection sites stores energy therein for improved self-scaling and eliminates the need for rigid supporting members.
Thus, they can be very small, both in diameter and length.
Other significant aspects and features of the present invention include ct~hanced fatigue resistance and enhanced adhesion to a flexible member of a prosthesis.
It is a general object of this invention to provide improved injection sites and a method of manufacturing same, especially for use in implantable prostheses, although they may be used wherever such sites have been used in the past as a self sealing septum or as a plug.
According to an aspect of the present invention, there is provided a self sealing body for use as an injection site with a syringe needle, the self sealing body comprising:
an elastomeric core member defining a circumferential outer surface, a longitudinal axis, a first side, and a second side, the elastomeric care member being initially tensioned along the longitudinal axis so as to deform the elastomeric core member radially inwardly; and a filament wrapping member wound spirally so as to circumferentially surround at least a portion of the circumferential outer surface of the elastomeric core member and generally uniformly compress the elastomeric core member inwardly in the radial direction such that the syringe needle may be inserted entirely through the elastomeric core member to create an insertion passage from the first side to the second side without piercing the filament wrapping member, and further such that the syringe needle may be completely withdrawn from the elastomeric core member with the radial compression of the filament wrapping member on the elastomeric core member sealing the insertion passage created by the syringe needle, the elastomeric core member initially being generally deformed from an undeformed configuration prior to the filament wrapping member being wrapped spirally thereabout, the filament wrapping member preventing the elastomeric core member from returning to the undeformed configuration and thereby generally uniformly compressing the elastomeric core member.
According to another aspect of the present invention, there is provided a self sealing injection site for use with a syringe needle, the self sealing injection site comprising:
an elastomeric core member having a longitudinal axis and defining a pair of opposing surfaces and a circumferential outer surface interconnecting the pair of opposing surfaces, the elastomeric core member being initially tensioned along the longitudinal axis so as to deform the elastomeric core member radially inwardly toward the longitudinal axis and increase the density of the elastomeric core member in a radial direction; and a filament wrapping member wrapped spirally around and circumferentially surrounding at least a portion of the elastomeric core member and generally uniformly -4a-compressing the elastomeric core member inwardly in a radial direction such that the syringe needle may be inserted entirely through the elastomeric core member to create an insertion passage extending between the pair of opposing surfaces without piercing the filament wrapping member, and further such that the syringe needle may be completely withdrawn from the elastomeric core member with the radial compression of the filament wrapping member on the elastomeric core member sealing the insertion passage created by the syringe needle, the elastomeric core member initially being generally uniformly deformed from an undeformed configuration prior to the filament wrapping member being spirally wrapped thereabout, the filament wrapping member preventing the elastomeric core member from returning to the undeformed configuration and thereby generally uniformly compressing the elastomeric core member.
According to another aspect of the present invention, there is provided a method of making a self sealing injection site, the method comprising the steps of:
stretching an elastomeric body under tension from a non-deformed configuration to a deformed configuration;
placing a wrapping member around the elastomeric body; and releasing the tension on the elastomeric body, the wrapping member compressing the elastomeric body and preventing the elastomeric body from returning completely to the non-deformed configuration, thereby producing a self sealing injection site.
According to another aspect of the present invention, there is provided a method of making a self sealing injection site, the method comprising the steps of providing an elastomeric core and a strand member, the elastomeric core having a length and an initial cross-sectional dimension;
applying tension to the elastomeric core to decrease the initial cross sectional dimension;
applying an adhesive to the strand member;
winding the strand member around the elastomeric core over at least a portion of the length thereof while the elastomeric body is under tension, the strand member forming a generally spiral configuration circumscribing the portion of the elastomeric core;
curing the adhesive;
relaxing the tension on the elastorneric core, the strand member compressing the -4b-elastomeric core and preventing the elastomeric core from returning completely to the initial cross sectional dimension; and cutting the elastomeric body and the strand member into at least one section corresponding to the self sealing injection site, thereby producing at least one self S sealing injection site having an elastomeric core in a compressed configuration.
According to another aspect of the present invention, there is provided a In combination, a device including an opening therein and a sealing body closing the opening, the sealing body having an elastomeric core defining a circumferential surface and a filament wrapping member wound spirally around at least a portion of and IO disposed on the circumferential surface, the elastomeric core being initially deformed prior to the filament wrapping member being disposed thereon, the filament wrapping member compressing the elastomeric core radially and generally uniformly such that an insertion passage may be created through the elastomeric core without piercing the filament wrapping member, and further such that the insertion passage will automatically 15 seal due to the radial compression of the filament wrapping member on the elastomeric core, the elastomeric core initially being deformed from an undeformed configuration, the filament wrapping member preventing the elastomeric core from returning to the undeformed configuration and thereby maintaining the generally uniform compression of the elastomeric core.
20 According to a further aspect of the present invention, there is provided an injection site for use with a syringe needle, the injection site comprising:
an elastomeric body; and a filament wrapping member wound spirally around at least a portion of the elastomeric body so as to generally uniformly compress the elastomeric body and 25 provide stored energy of compression in the elastomeric body such that the syringe needle may be inserted through the elastomeric body to create an injection passage without piercing the filament wrapping member, and subsequently sealing after the syringe needle is withdrawn from the elastomeric body, such that the self sealing property of the elastomeric body is improved by the stored energy of compression, the 30 elastomeric body initially being generally deformed radially inward from an undeformed configuration prior to the filament wrapping member being mounted thereon, the filament wrapping member preventing the elastomeric body from returning to the -4c-undeformed configuration and thereby generally maintaining the compression of the elastomeric body.
Brief Description of the Fi ures Other objects of the present invention and many attendant advantages will be readily appreciated as it becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the Figures thereof and wherein:
Figure 1 illustrates a perspective view of an injection site of, the present invention;
Figure 2 illustrates a cross-sectional view along line 2-2 of Figure I;
Figure 3 illustrates a method of application of a wrapping to a stretched rod of elastomeric material in forming an injection site of the invention;
Figure 4, an alternate embodiment, illustrates a cross-section of an injection site having a monofilament member winding about the circumferential surface thereof;
Figure 5 illustrates a perspective view of a testicular prosthesis, incorporating the present invention;
Figure 6 illustrates an alignment fixture;
Figure 7 illustrates the method of injecting adhesive into the interior of the elastomeric shell;
Figure 8 illustrates the elastomeric shell being rotated off vertical to form an evacuation dome;
Figure 9 illustrates the elastomeric shell and self sealing injection site subsequent to fixture removal;
Figure l0A illustrates complete encapsulation of the self scaling injection site within the cylindrical bore of the elastomeric shell;
Figure 10B illustrates radiopaque encapsulation of the self sealing injection site;
Figure l OC illustrates encapsulation of the self sealing injection site; and Figure I1 is a schematic showing of a device depicted generally, making use of the invention.

2,19365-1 Detailed Dcscri~tion of the I'rcCcrrcd Embodiments Figure 1 illustrates a perspective view of a preferred injection site 10 according to the invcnlion having a central elastomcric silicone core or'slug 12 wrapped and bound in compression by a fiberglass strand 14 in the Corm of a coil or wrapping 16. Olhcr suitable clastomcric materials may be used as well. The fiberglass strand 14 is preferably impregnated with adl;csivc which adheres to the outer circumfercntial surface of the elastomeric silicone core 12. The adhesive coating when cured causes adjoining langcnlial areas oC lhc fiberglass continuous coil 16 to mutually adhere to cacti olhcr and provide Ior maximum holding strength. In lhc altcrnalivc, strand 14 may be wound tightly enough for adjacent portions of the strand to overlap each olhcr or mulliplc layers of strand may be provided, thus creating a continuous wrapping of fiberglass coated with adhesive.
Also, in tlic alternative, wrapping 16 may comprise a metal winding as of fine wire or may even comprise a single flat piece of metal in a ring shape or the like tightly encompassing the entire peripheral area oC body 12 under compression.
Furthermore, the outer surface may be roughened, as by etching or the like, to adapt it for improved scaling cngagemetU or contact.
Referring flow to Figure 2, this Figure is a cross-sectional view along line 2-2 of Figure 1 in which all nuIIICCaIS COIrcSpoild to those elements as previously described in Figure 1. Illustrated in particular is the elastomeric silicone core or slug 12, the diameter of which has been previously reduced from a larger diameter to a smaller diameter by stretching its predecessor rod to thereby place body 12 under compression and also to increase its density as later described in detail.
'I')te Owens Corning fiberglass strand 14 a synthetic fiber, having a nominal diameter of .0065 inches by way of example and for propose of illustration only, is constructed of a great number of fiberglass fIISIIlcllis 15a-15n, and is impregnated with a medical grade adhesive 18 such as Raumedic medical grade adhesive (SI 1511). The adhesive is applied under tension. Owens Corning 408 fiberglass filaments 15a-15n, by way of eXltllple aIld fOC purposes of illustration only, make up the fiberglass strand 14 and are presently preferred. This is a continuous filament yarn (Yarn No. ECD 225 110) of approxintatcly nominal yards per pound - 22,500, 3.OIbs. an average breaking strength and an approximate diameter of 0.0065 inches, Denier equivalent I98 and has the following designation ECD I15 110 636. It is available from LM Specialty Yarns, .- . 21 ~~65~
-G-Owcns Corning Fiberglass, Fiberglass 'Power, 'Polcdo, Ohio 43659. The strand could also be polyester tcrephthalate or other suitable synthetic material, or natural fibers such as silk, cotton, ete. or metal, as already discussed above. ' .
The term "strand" is used herein in a generic sense to include simple fibers, filaments, multi-fibers, multi-filaments and the like whether of synthetic, natural or metallic nature, including gold, silver, stainless steel and the like.
The fiberglass adhesive impregnated strand 14; which nominally is round, is lubricated by the adhesive 18 and assumes a flattened profile spanning the distance as designated by arrows 14a-14b in I~igurc 2 with the bulk of the filaments 15a-15n being alil;ned at a peak 14c which tapers off to include a lesser amount of filaments ISa-lSn at cacti side of tile peak in valleys 14d and 14c. The medical gl-adc adhesive 18 1111pI'CgIlatCd 111LU tllC straIldS 14 mutually bonds the fiberglass filaments 15a-15n of each flattened strand I4 to themselves and to the adjacent turns of the strand 14 which forms the homogenous surrounding coil 1G about the elastic silicone core I2.
The adhesive also bonds fiberglass filaments 15a-15n to the elastic silicone core 12. The flattened profile or the fiberglass filaments 15a-15n impregnated and adhered to each other about the elastic silicone core 12 preserUs when cured a suitable outer bonding surface for adhesivcly bonding and securing the injection site within the bore, opening or other orifice into which the injection site is to be incorporated. For example, in a preferred form it will be incorporated 1I1t0 atl lmplaIltablc prosthesis which may bc, but not limited to, tissue expanders, mammary prostheses, prostheses used for fluid infusion or prostheses used for drub delivery. Also, the injection site may be inserted as a lumen plug in a prosthesis or other device.
Considering the injection site as shown in Figures 1 and 2, it is seen that an clastotneric core 12, preferably in a slug-like configuration is provided having opposite surfaces 12a and 12b interconnected by a peripheral edge or circumferential surface 20. The body is held in compression by a tight wrapping around surface which is preferably held in place by a suitable adhesive, the wrapping being accomplished when core 12 is in tension.
A preferred method of manufacturing such an injection sift will now be described with particular reference to I=figure 3. Figure 3 illustrates a method of application of wrapping 1G to a silicone rod. 'The numerals referred to in Figure 3 correspond to those elements previously described.

2~9~~5t A I-ixturc generally indicated at 22 includes a base 24, opposing fixed upright supports 2G and 28, and Inovcablc upright supports 30 and 32. An elastic S111C011C 1-UCl 13, f01- CXI1111p1C, Illay 1)C faSlllUIlCd by 11101d1I1g. 0I-CXtflldlllg S11ICOI1C Or other elastomcr material such as gum rubber, or by molding liquid silicone 1-ubbcr or other elastonler material. The rod 13 is supported between rotatable clamps 34 and 3G
at the upper portion of tllc fixed support 28 and movable support 30, respectively. A
threaded crank rod 40 supported by fixed support 2G is turned by a crank 42 to horizontally position Inovablc support 30, thus causing rod 13 to be strctclled and elongated between the I-OtatablC CI:I111pS 34 and 3G. This stretching and elongating causes rod 13 to be put under tension and to decrease the profile cross-section or diameter of the rod. Tllis decrease in diauletcr provides'a source of cores 12 Cor the injection sites of the invention which causes inflation needle punctures to be self sealing. TI11S COIllpaCt1011 1-CSUltlIlg fI'olll tension is held in reduced cross-section by the application of an adhesive ilnpregnated wrapping 1G which is preferably a closely wound strand of fiberglass in a closely spaced form about the outer periphery of tile stretched and elongated rod 13 and which may be distributed over most of the length thereof. A threaded rod, crank and gear asselnbly advances movable support 32 to apply all adllCSIVC 1111pI-CgilaICd SlI-Gild 14 over, around alld about the stretched and elongated rod 13. The strand winding process may be automated. A threaded crank rod 44 having a crank 4G is supported by the opposing fixed supports 2G and 28. Gears 48 and 50 align over and are fixed to tile threaded crank rod 44 for rotation by it upon rotation of crank 4G. Gears 52 and 54 arc supported for rotation at the upper.cnds of fixed support 28 and movable support 30 and are also attached to the rotatable clamps 34 and 3G, respectively. Gear 50 meshes with gear 54 and gear 52 Incshcs with and slidingly engages gear 48. Crank 4G, when activated, turns the threaded craIlk rod 44 and gears 48 and 50 directly, and also turns rotatable clamps 34 and 3G at equal rates through the intermeshed gears 52 and 54 to rotate the elongated and stretched rod I3 .
about its longitudinal cc(ltral axis.
The action of the crank rod 4G also causes movable support 32 to be horizontally moved and positioned as indicated by arrow SG to apply the adhesive impregnated strand 14 in a uniform manner around and about tlae stretcltcd and elongated rod 13 as it rotates between rotatable clamps 34 and 3G. A strand source in the form of a spool 58 and an adhesive source container GO of medical grade adhesive ~ i 9~6~t.
.,_ _s_ 18 secures to the upper portion of tllC IIIOVabIC SUppOI't 32. Spool 58 offers a slight drag so that as the strand is pulled Crom spool 58 by rotating rod 13 a slight amount of tension is applied to strand 14 so that flattenilig of the strand will occur.
Strand 14 aligns in a perpendicular fashion to the elongated rod 13 as it passes through the source container and as it is wound about rod 13. '1'lle strand is wound SU aS to place the coils thereof as closely together as possible on the rod. Strand 14 is impregnated by the medical grade adhesive 18 as the strand passes through the medical grade adhesive 18 in the adhesive source colltaincr G0. Adhesive 18 is then allowed to curt and dry under tension after lhc strand has been wrapped about rod 13. When the axial tension on rod 13 is released, the rod is then placed under radial compression by the cured winding.
The wrapped rod is then cut in lengths Cor subseduent use as discrete individual injection sites, each of which may be used for placement within the injection orifice of a scaled prosthesis or other device. The self contained injection site can also be used as a lulnen plug in any type of device, medical or other wise. The wrapping presents a bonding surface for bonding the site into an opening in a prosthesis or the like.
The material of rod 13 may include a colorant such as titanium dioxide for visualization or it may include a material such as barium sulfate to render it radiopaque for visualization under radioscopy.
Pigure 4, an alternative embodiment, illustrates a cross-sectional vices of an injection site wound with a monofilament member. Illustrated in particular Is all CIaStIC SIIICOlIC C01'C 12 h aVlilg a d18111CICr redUCCd fC0111 a largCr dlametCr t0 COInpaCt its diameter and increase its density as previously described. A metallic or plastic that retains its round shape, monofilament or other suitable member 14 laden with a medical grade adhesive 18 is wound under a slight tension about an elastomcric rod as before to provide the elastic silicone core 12 with pcripllcral winding or wrapping in a manner consistent with the teachings of the previous description of tile invention.
Alternately, bifilar, 1110110f11aI11CIlt or multiple monofilaments members of synthetic, natural or Inetallic material may be used. Also, the wrapping need not be parallel when bifilar or the like but lnay be helical and so forth. Adhesive 18 adheres in a plurality of areas and along a series of points and provides for maximum holding power of the wrapping.
'rhe continuous spread of adhesive 18 over the peripheral surface 20 provides continuous adhesion of the filament member 14 to itself and to the elastomer rod/core, thus forming a semi-rigid casing like member. The medical grade adhesive 1 s vows _9_ ~ i 9:3.6.~.~
and bridges across the spaces between the winding to encapsulate coil member 14.
Curing is accornplished under tension. The assembly is then cut to appropriate lengths for incorporation into an implantable device as'individual injection sites.
The bonding of the turns of coil 14 to itself and tire bonding of the turns of coil 14 t~
the elastic silicone core 12 provides maximum bondage and adherence to forcibly maintain and contain the stretched elastic silicone core 12 under radial compression at its desired decreased diameter (as compared to its source rod) which insures sealing of a syringe needle puncture or the Iikc subsequent to syringe needle withdrawal from the injection sift.
CX~lMPLLS
In a preferred embodiment injection sites have been made from Dow Corning Q7-4735 silicone elastomer. An equivalent material is MED-4735 from the Nusih Technology Company. Six to ten inch henglh molded or extruded rods of initial diameter 0.230 inches were stretched until their initial diameter decreased by about 17 i.e., to a diameter of about 0.190 inches. Fiberglass filament was then passed through Raumedic medical grade adhesive (SI 1511) wrapped about the stretched rods while in their tensioned StatC. The rod was then sliced into 0.090 inch lengths after the adhesive cured to provide a plurality of sites or plugs according to the invention.
Care should be taken to avoid too small a slice of the rod in forming the scptum/sitc as it may deform under the stress. Using the aforementioned rnatcrials, for example, it was determined that a 0.250 lllch diameter rod strclclred down to 0.190 inches and then sliced to 0.080 inch thick slices tended to be unstable and to deform or bow. On the other hand, 0.230 inch rods stretched to 0.190 made stable scptum/sites of 0.090 to 0.100 inches prick. Obviously, in the case of any particular materials and sizes, same minor "cut and try" may be necessary. Generally speaking, the aIrlount of compression will determine the length of the injection sift - more compression requires greater length.
As already rncntioned, this invention was developed to be used primarily in a saline Cilhed testicular prosthesis.
A testicular prosthesis shown in Figure 5, is an example of a hollow device having a chamber to be closed by a self sealing septum or plug. Such a prosthesis may comprise a shell as is shown in Figure 5. More specifically, Figure 5 _10-illustrates a perspective view of a testicular prosthesis generally indicated at 80 including a shell 82 which is transfer, injection, compression or otherwise suitably molded from a silicone elastomer such as Dow Q7-4840 or Q7-4735 or equivalent material. The elaslomeric shell 82 is preferably elliptical in longitudinal cross section to replicate lhc shape of a testicle and is of a circular transverse cross section. Shell 82 can be produced ttl a IlUIllbCr of sizes t0 aCC0I11I110datC the proper testicle size and may be filled any desired tension or feel. The elastomcric shell wall is approximately .030 inches thick on the sides 84 for purposes of example and illustration only, and increasingly tapers to a thickness of 0.170 inches at one end 8G to accommodate a self scaling injection site of the invention 10. The sclC scaling injection site 10 is bonded in the opening which is carried in an opening 9G in the shell by a medical grade adhesive 90 and aligned thereto prior to bonding as described later in detail.
A self presenting suture lab 92 aligns at the opposing end for securcmcnt of tIc shell 82 to the scrotum or other convenient attachment point.
The injection site is bonded to the shell with the help of an assembly fixture shown in Figure G. The fixture locates the injection site in the center of the wall cavity leaving space for .025 inch of adhesive circumferential around, and .050 inches of adhesive over the injection site. Silicone adhesive, thinned with xylene, is injected through the fixture, or lhrouglt the injection site, to a depth of about .030 inches. The adhesive is allowed to cure 24 hours then the shell and injection site are pulled away from the fixture. The top of the injection site is then covered with adhesive.
More specifically, Figure G illustrates a fixture generally indicated at 94 for alignment of the self-sealing injection site 10 concentrically with the cylindrical bore 9G of the thick end 8G of the elastomeric shell 82 where all numerals correspond to those elements previously described. The fixture 94 includes generally a nutnber of radiused portions including an upper radiuscd body portion 98 and a lower radiused body portion 100. A cavity 102 conforming to the thick end 8G of the clastomcric shell 82 aligns centrally in the upper radiused body portion 98 for subsequent alignment with the satnc as illustrated in Figure 7. Another radiused portion 104 extends upwardly into the region of the cavity 102 to closely align within the cylindrical bore 9G
of the elastomcric shell thick end 8G as illustrated in Figure 7: Three bores lOG, 108 and I I0 align axially either partially or fully in the radiused portion 104, the upper radiused body portion 98 or the lower radiused portion 100 as illustrated. Bore IOG

accommodates the self scaling injection site 10 and bores 108 and 110 acconunodate a fill needle 112 as illustrated in Figure 7.
Figure 7 illustrates the method of injecting medical grade adhesive 114 into the interior 11G oC the elastolneric shell 82 where all numerals correspond to those elements previously described. 'The clastomeric shell 82 is aligned in the conforming shaped cavity 102 of the fixture 94. The radiuscd portion 104 of fixture 94 aligns centrally within the cylindrical bore 9G of clastolneric shell 82. The self scaling injection sift 10 which is placed in tile upper bore lOG prior to alignmerU of the elastomeric shell 82 with fixture 94 is also centrally aligned within the cylindrical bore lU 9G. WI1CI1 allgIlIllCllt has been accomplished, a non-coring needle 112 having one or more ports 113 and having a source of thinned medical grade adhesive 114 attached thereto is inserted through the bores 110 and 108 and through the self-sealing injection site 10. Adhesive 114 then enters the lower region of the elastomeric shell 82 about and above the vicinity of the bore 9G as illustrated so that adhesive 114 covers the lower inner region of the elastomeric shell 82, the serialization and identification area 11G, and the top surface of the self sealing injection site 10. The needle 112 is then w1t11dC1WIl from the fixture 94 and ClastoII7crIC sllell 82 and fixture 94 are slowly totaled and arc progressively tipped during rotation to allow the adhesive I14 to puddle in an annular fashion around the center portion to form the evacuation dome 118 as illustrated in Figure 8. The adhesive is then allowed to cure after formation of evacuation dome 118. After curing, fixture 94 is withdrawn from engagement with the elastomeric shell 82 leaving the self-sealing injection site 10 concentrically.aligned within the cylindrical bore 9G aIld adhered to the lower region of tire elastomcric shell 82 by the interceding medical grade adhesive 114 as illustrated in Figure 9.
Figure 8 illustrates the elastonlcric shell 82 being rotated about an axis 120 which is at a variable angle 122 to the vertical 124. fhe angle 122 gencraily is 35°, but eau include a range of degrees in that several factors such as but not limited to clastomeric shell 82 size, adhesive viscosity, rate of notation, angle of rotation, temperature, and adhesive setting time will require different angular settings, different rotation speeds, as well as different rates of tipping, other than described herein. A
suitable rotatable clamping device 12G slowly rotates the fixture 94 and tile contained adhesive laden elastomeric shell 82 at a speed of 4 rpm plus or minus one rpm.
The viscous adhesive 114 flows outwardly leaving a shaped evacuation dome 118 centered ~ ~ 936~~1 radially about the axis of the clastomeric shell 82 when shell 82 is tipped at an angle as now described in detail. The axis of rotation 120 is progressively and slowly tipped over a period of one minute from the vertical axis 124 until rcaching'the desired angle 122 of about 35° which is the most desirable of alrglCS WIriClr C1I1 raIrgC from about 35 to 55 degrees depending on the size of tire elastomeric shell 82 alrd other factors previously described. During this slow tipping and rotation, adhesive 114 flows from the area over and about the upper area of the self scaling injection site 10 and along the lower portion of the inner surface 128 to vacate adhesive 114 from the area overlying the self sealing injection site 10 to fOrlrl the evacuation dome 118.
alternatively, clastomeric shell 82 C1I1 be spun rapidly from about S00 to 1,000 rpm for 10 to 20 seconds, Cor purpose of example, along the vertical axis to cause the adhesive 114 to flow away from the center to form the evacuation dome 118.
Figure 9 illustrates the elastomeric shell 82 and the self-sealing injection site 10 subsequent to removal of the fixture 94 where all numerals correspond to those elements previously described. The self sealing injection site 10 is suspended concentrically from the adhesive 114 within the cylindrical bore 9G. An annular space 130 defined by the annular area between the circumferential surface of ttie self-sealing injection site 10 and the adjacent walls of tire cylindrical bore 96 and another cylindrical area 132 between the plane of the lower surface of the self sealing injection site 10, tire bottom of the annular space 130 and a plane across the outer opening of the cylindrical bore 96 are then backfilled by additional medical grade adhesive 114 as illustrated in Figure l0A to fully and adhcsively secure the self-sealing injection site 10 within the cylindrical bore 96 of the elastomeric shell 82.
It is to be understood that the annular space I30 arrangement and backfill space 132 represent a preferred embodiment of tire mounting arrangement for placement of the injection sites and plugs of the invention in openings of various devices. A tight fit of the injection site or plug within such openings may be acceptable in many devices, the permanent placement being facilitated by adhesive or other bonding.
Figure l0A illustrates the complete encapsulation of self-scaling injection site 10 within the cylindrical bore 96 of the elastomeric shell 82 containing a saline or other suitable biologically safe fluid 134 where all numerals correspond to those elements previously described. I3ackfilling with adhesive 114.of the cylindrical bore 9G in areas 130 and 132 forms a homogenous surroundment of adhesive 114 about the -13- 1~ ~ ~~~5 self scaling injection site 10. The newly applied backfill adhesive of the same type Provides for bolldlllg of floe previously cured adhCSIVC alld the newly applied adhesive to form a homogenous hooding.
The clastomeric shell 82 is of a medical grade low durometer silicone clastomcr, thus allowing the clastonlcric shell 82 to be soft and resilient.
The self scaling injection site 10 is also constructed of a low durometer medical grade silicone elastomer which llaS 1111n1111aI palpablllty alld which is easily compressed.
The silicone adhesive 114 when cured and hardened has durometer and elongation qualities similar to . the otlicr silicone elastomcric members which it bonds togceher. The silicone adhesive 114 is blOCOII7Patable alld blOStabIC.
Also illustrated in this Figure is an annular area 11G for serialization and identification of the pl-oduct.
Figure lOB illustrates the complete encapsulation of a self sealing injection site 10 incorporating a band of suitable radiopaque adhesive 114a containing barium sulfate (BaSo,) in a range of 14% to provide for a radiopaquc member surrounding the self sealing injection site 10 in the upper portion of the annular area 130 of the cylindrical bore 9G surrounding the self sealing injection site 10.
Adhesive 114 is then backfilled into the area 132 of the cylindrical bore 9G about the remaining portion of the self-sealing injection site 10 and in direct adhesion with the barium sulfate laden adhesive 114a in the annular area 130 as was described in Figure 10A.
All numerals correspond to these elements previously described.
Figure lOC illustrates the complete encapsulation of a self:sealing injection site 10 incorporating a band of suitable radiopaque adhesive 114b containing barium sulfate (BaSo4) in a range of 14% to provide for a radiopaque member completely surrounding the self-scaling injection site 10 in the annular areas 130 and 132. Adhesive 114b is backfilled in the areas 130 and 132 of the cylindrical bore 9G
in direct contact with the adhesive 114 to complete the encapsulation of the self scaling injection site 10. All elements correspond to those elements previously described.
Referring now to Figure 11, a schematic showing of a generalized device 80 is depicted. Device 80 may be any device requiring a septum or plug 10 of the invention including ally of the aforementioned devices or any other kind whether implantable of not. Such a device includes an opening 9G closed by an injection site or a plug IO of the invention. Note that opening 9G does not include any supporting structured about it. In this embodiment, plug 10 fits tightly in opening 96 and may rcduirc only a shin layer of adhesive 104 to seal it therein. Such a Ct may merely be an interference fit taking advantage of the continuous peripheral or circumfcrential surface of plug 10 for scaling engagement, of course as in other embodiments plug 10 is wrapped in tension.
While L111S lIIVCI1t10I1 Illay bC eIIlbOdlCd in many different forms, there arc described in detail herein specific preferred CIllbUdllllCIltS Of flit invention. 'This dCSCr1pt10Il lS all eXCnlpIlfiCaltoll Of the principles of the invention and is not intended to limit the invention to the particular embodicncttts illustrated.
Variations of the invention include but arc not limited to: colored injection sites for visualization, radiopaquc sites for fluoroscopy and tailoring of the compressive loading by varyntg the diameter reduction in the rod when stretching it.

Claims

What is claimed is as follows:

1. A self-sealing body for use as an injection site with a syringe needle, said self-sealing body comprising:
an elastomeric core member defining a circumferential outer surface, a longitudinal axis, a first side, and a second side, said elastomeric core member being initially tensioned along said longitudinal axis so as to deform said elastomeric core member radially inwardly; and a filament wrapping member wound spirally so as to circumferentially surround at least a portion of said circumferential outer surface of said elastomeric core member and generally uniformly compress said elastomeric core member inwardly in said radial direction such that the syringe needle may be inserted entirely through said elastomeric core member to create an insertion passage from said first side to said second side without piercing said filament wrapping member, and further such that the syringe needle may be completely withdrawn from said elastomeric core member with the radial compression of said filament wrapping member on said elastomeric core member sealing the insertion passage created by the syringe needle, said elastomeric core member initially being generally deformed from an undeformed configuration prior to said filament wrapping member being wrapped spirally thereabout, said filament wrapping member preventing said elastomeric core member from returning to said undeformed configuration and thereby generally uniformly compressing said elastomeric core member.

2. A self sealing injection site for use with a syringe needle, said self sealing injection site comprising:
an elastomeric core member having a longitudinal axis and defining a pair of opposing surfaces and a circumferential outer surface interconnecting said pair of opposing surfaces, said elastomeric core member being initially tensioned along said longitudinal axis so as to deform said elastomeric core member radially inwardly toward said longitudinal axis and increase the density of said elastomeric core member in a radial direction; and a filament wrapping member wrapped spirally around and circumferentially surrounding at least a portion of said elastomeric core member and generally uniformly compressing said elastomeric core member inwardly in a radial direction such that the syringe needle may be inserted entirely through the elastomeric core member to create an insertion passage extending between said pair of opposing surfaces without piercing said filament wrapping member, and further such that the syringe needle may be completely withdrawn from said elastomeric core member with the radial compression of said filament wrapping member on said elastomeric core member sealing the insertion passage created by the syringe needle, said elastomeric core member initially being generally uniformly deformed from an undeformed configuration prior to said filament wrapping member being spirally wrapped thereabout, said filament wrapping member preventing said elastomeric core member from returning to said undeformed configuration and thereby generally uniformly compressing said elastomeric core member.

3. ~The self-sealing injection site of claim 2, including adhesive associated with the filament wrapping member to adhere the filament wrapping member to the elastomeric core member.

4. ~The self-sealing injection site of claim 2, wherein the filament wrapping member is metal.

5. ~The self-sealing rejection site of claim 2, wherein the filament wrapping member is a synthetic material.

6. The self-sealing rejection site of claim 2, wherein the self-sealing injection site is at least partially inserted within a housing, and further wherein the filament wrapping member has an outer surface adapted for sealing contact with the housing.

7. The self-sealing injection site of claim 2, including a colorant to provide a distinctive color to the elastomeric core for the purpose of visualization.

8. The self-sealing injection site of claim 2, including a radiopaque material within the elastomeric core to provide visualization under fluoroscopy.

9. The self-sealing injection site of claim 2, including a colorant associated with the filament wrapping member to provide a distinctive color for purposes of visualization.

10. The self-sealing injection site of claim 2, including a radiopaque material associated with the filament wrapping member to provide visualization under fluoroscopy.

11. The self-sealing injection site of claim 2, wherein the elastomeric core member is in the form of a slug.

12. The self-sealing injection site of claim 11, wherein the slug is silicone.

13. The self-sealing injection site of claim 12, wherein the filament wrapping member is fiberglass.

14. The self-sealing injection site of claim 13, wherein the filament wrapping member is a generally continuous thin strand of synthetic material.

15. The self-sealing injection site of claim 2, wherein the filament wrapping member comprises a generally continuous thin strand of material.

16. The self-sealing injection site of claim 15, wherein the filament wrapping member is fiberglass.

17. The self-sealing injection site of claim 15, wherein the filament wrapping member is polyethylene terephthalate.

18. The self-sealing injection site of claim 15, wherein the filament wrapping member is a synthetic material.

19. The self-sealing injection site of claim 15, wherein the filament wrapping member is of natural fibers.

20. The self-sealing rejection site of claim 15, wherein the filament wrapping member is bifilar.

21. The self-sealing rejection site of claim 15, wherein the filament wrapping member is metallic.

22. The self-sealing injection site of claim 15, wherein the filament wrapping member is a monofilament.

23. The self-sealing injection site of claim 15, including adhesive associated with the filament wrapping member for bonding the filament wrapping member and the elastomeric core together.

24. The self-sealing injection site of claim 23, wherein the filament wrapping member is impregnated with the adhesive.

25. A method of making a self-sealing injection site, said method comprising the steps of:
stretching an elastomeric body under tension from a non-deformed configuration to a deformed configuration;
placing a wrapping member around said elastomeric body; and releasing the tension on the elastomeric body, said wrapping member compressing said elastomeric body and preventing said elastomeric body from returning completely to said non-deformed configuration, thereby producing a self-sealing injection site.

26. ~The method of claim 25, wherein subsequent to the step of releasing the tension on the elastomeric body, the method includes the step of separating the elastomeric body into a plurality of discrete segments to form a plurality of self-sealing injection sites.

27. ~The method of claim 25, wherein the wrapping member is a strand that is wound around at least a portion of the elastomeric body.

28. The method of claim 27, wherein the elastomeric body is an elongate rod having an outer surface, and the strand is wrapped spirally about said outer surface of said elongate rod.

29. The method of claim 27, further comprising the step of applying adhesive to the strand such that at least a portion of the strand bonds to the elastomeric body.

30. The method of claim 29, wherein the adhesive is applied to the strand prior to winding the strand on the elastomeric body.

31. The method of claim 27, wherein subsequent to the step of releasing the tension on the elastomeric body, the method comprises the step of slicing the elastomeric body and the wrapping member into segments to form a plurality of self-sealing injection sites.

32. The method of claim 25, wherein the method further comprises the step of:
applying adhesive to the wrapping member prior to winding the wrapping member around the elastomeric body.

33. The method of claim 32, wherein the elastomeric body is a rod having a generally circular cross-section.

34. The method of claim 32, further comprising the step of curing the adhesive prior to slicing the elastomeric body and the wrapping member into a plurality of like self-sealing injection sites.

35. ~A method of making a self-sealing injection site, said method comprising the steps of:
providing an elastomeric core and a strand member, said elastomeric core having a length and an initial cross-sectional dimension;
applying tension to said elastomeric core to decrease said initial cross sectional dimension;
applying an adhesive to said strand member;
winding said strand member around said elastomeric core over at least a portion of said length thereof while said elastomeric body is under tension, said strand member forming a generally spiral configuration circumscribing said portion of said elastomeric core;
curing said adhesive;
relaxing the tension on said elastomeric core, said strand member compressing said elastomeric core and preventing said elastomeric core from returning completely to said initial cross sectional dimension; and cutting the elastomeric body and the strand member into at least one section corresponding to the self-sealing injection site, thereby producing at least one self-sealing injection site having an elastomeric core in a compressed configuration.

36. ~The method of claim 35, wherein the elastomeric core is cut into a plurality of segments to produce a plurality of self-sealing injection sites.

37. ~The method of claim 35, wherein the elastomeric core has a generally round cross-section.

38. ~The method of claim 35, wherein the elastomeric core is silicone.

39. ~The method of claim 35, wherein the strand member is fiberglass.

40. ~The method of claim 35, wherein the strand member is polyester terephthalate.

-21-~

41. ~The method of claim 35, wherein the strand member is wound spirally such that the strand member forms a series of generally parallel coiled loops extending along the~
portion of the elastomeric core.

42. ~In combination, a device including an opening therein and a sealing body closing said opening, said sealing body having an elastomeric core defining a circumferential surface and a filament wrapping member wound spirally around at least a portion of and disposed on said circumferential surface, said elastomeric core being initially deformed prior to said filament wrapping member being disposed thereon, said filament wrapping member compressing said elastomeric core radially and generally uniformly such that an insertion passage may be created through said elastomeric core without piercing said filament wrapping member, and further such that said insertion passage will automatically seal due to the radial compression of said filament wrapping member on said elastomeric core, said elastomeric core initially being deformed from an undeformed configuration, said filament wrapping member preventing said elastomeric core from returning to said undeformed configuration and thereby maintaining the generally uniform compression of said elastomeric core.

43. ~The combination of claim 42, wherein the device is a medical device.

44. ~The combination of claim 43, wherein the device is implantable.

45. ~The combination of claim 42, wherein the sealing body is an injection site.

46. ~The combination of clam 42, wherein the sealing body is bonded at least partially within the opening.

47. ~The combination of claim 42, wherein the filament wrapping member is a generally continuous thin strand of material.

48. The combination of claim 47, including an adhesive associated with the filament wrapping member to adhere the filament wrapping member to the elastomeric core.

49. ~An injection site for use with a syringe needle, the injection site comprising:
an elastomeric body; and a filament wrapping member wound spirally around at least a portion of said elastomeric body so as to generally uniformly compress said elastomeric body and provide stored energy of compression in said elastomeric body such that the syringe needle may be inserted through said elastomeric body to create an injection passage without piercing said filament wrapping member, and subsequently sealing after the syringe needle is withdrawn from said elastomeric body, such that the self sealing property of said elastomeric body is improved by said stored energy of compression, said elastomeric body initially being generally deformed radially inward from an undeformed configuration prior to the filament wrapping member being mounted thereon, said filament wrapping member preventing said elastomeric body from returning to said undeformed configuration and thereby generally maintaining said compression of said elastomeric body.