CA2225477A1 - Access portal and method - Google Patents
Access portal and method Download PDFInfo
- Publication number
- CA2225477A1 CA2225477A1 CA002225477A CA2225477A CA2225477A1 CA 2225477 A1 CA2225477 A1 CA 2225477A1 CA 002225477 A CA002225477 A CA 002225477A CA 2225477 A CA2225477 A CA 2225477A CA 2225477 A1 CA2225477 A1 CA 2225477A1
- Authority
- CA
- Canada
- Prior art keywords
- portal
- housing
- septum
- open end
- cup
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
- A61M2039/0072—Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S604/00—Surgery
- Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable
Abstract
The present invention provides a portal (20) for subcutaneous implantation, where the portal (20) includes a housing having a first end (124), a second end (126), an inner wall (123), and a lumen (127) between the first and second open ends. In one preferred embodiment, the first open end (124) of the housing (120) is sealed by an elastomeric septum (122), which has been injection molded into place. The elastomeric septum (122) is bonded to the inner wall (123) of the housing (120) adjacent the first open end (124). The second open end (126) is sealed to define a reservoir (140) accessible through the septum.
Description
CA 0222~477 1997-12-22 ACCF,.~ PORT~ ,THOl) Technical Field The present invention relates to implantable biocompatible access portals 5 used in connection with the delivery of medicants, and other ph~rm~ellfical fluids into a body, or the withdrawal of fluids from the body.
,, R~ roun~
Access portals provide a convenient method to repeatedly deliver meclic~nt~
to remote areas of the body without lltili~in~ surgical procedures. Portals are totally 10 implantable within the body, i.e. subcutaneous, and permit the infusion of medicants, pal~,..Leldl solutions, blood products, and other fluids. Portals may alio be used for blood sampling.
A typical portal generally includes a housing assembly, a septum, and an outlet. The housing assembly and septum define a reservoir which is ~cces~il sle15 through the septum. The outlet includes or is ~tt~ched to a c~thtoter which ~cçsses a vein. The cath~-ter delivers fluid from the portal to a remote location in the body, for example the superior vena cava. The outlet may be an integral c~th~ter as in IJ.S.
Patent No. 4,471,885 to Weeks, or a separate metallic outlet tube assembly as inU.S. Patent No. 5,213,574 to Tucker. In the case of a portal with an outlet tube20 assembly, a catheter will be attached thereto.
In common practice, the portal is implanted within the body and the ç~lth~-ter is routed to a remote area were fluid is desired to be delivered. To deliver the fluid, a caregiver locates the septurn of the portal by palpation of the patient's skin. Portal access is accomplished by percutaneously inserting a needle, typically a non-coring 25 needle, perpendicularly through the septum of the portal and into the reservoir. 'rhe drug or medicant is then a-lmini~tered by bolus injection or continuous infusion.
Ordinarily, the fluid flows through the reservoir into the catheter and finally to the site were the fluid is desired.
Portals generally come in two difr~ L types, surgical and cosmetic.
30 Surgical portals are used to deliver medicants, including chemotherapy drugs which may be harmful to surrounding tissue, as well as sampling blood. Cosmetic port~als, on the other hand, are utilized to deliver saline or some other non-reactive substamce to a prosthesis which supplements a body feature. An example of a surgical port;al is shown in U.S. Patent No. 5,213,574, while an example of a cosmetic portal is shown 35 in U.S. Patent No. 4,471,885.
A concern for all portals, and especially portals used for surgical procedures, is blowout. Blowout describes the catastrophic failure of a portal when the ~.es~ule inside the reservoir is great enough to ~ n~ge the septum from the housing of the CA 0222~477 1997-12-22 W O 97/01370 PCTrUS96/11049 portal. Disengagement of the septum may injure the patient, and release medication contained in the portal. The released medicant will often be harmful to the surrounding tissue. Blowouts have a variety of causes. For example, a blowout may be caused if the catheter downstream of the portal is occluded and a bolus injection is attempted. When the bolus injection is attempted the injected fluid cannot travel through the catheter and as fluid is contin~ ly injected into the reservoir of the portal the l,ie~ e increases until the septum is disengaged.
Blowouts are of a much greater concern for surgical portals than for cosmetic portals. A ~lilll~ reason for this is that the reservoirs of surgical portals often 10 contain caustic medicants while the reservoirs of cosmetic portals do not. Toprevent blowout, surgical portals typically hold the septum in the housing of the portal under great compression. For example, the SIMS Deltec PORT-A-CATH
brand portal uses an i"lelre~ence fit to both radially and axially compress the septum to hold it in place.
In contrast, some cosmetic portals, for example, the portal shown in U.S.
Patent No. 4,371,885, are sealed to the housing by collll)les~illg only a preformed ridge around the septum with, for example, a threaded ring. The threaded ring ofU.S. Patent No. 4,371,885 does not provide as much com~,es~ive force as the PORT-A-CATH portal.
Another concern with porta,ls, and more importantly with surgical portals, is puncture life. Puncture life describes the number of punctures a septum can resist and still provide a fluid tight seal. If the septum does not reseal after an injection is made, the injected medicant may leak out of the reservoir and possibly harm the surrounding tissue. Once again, septum life is of greater importance in surgical25 portals than cosmetic portals because of the nature of the medicant being injected.
Commercially successful prior art surgical portals have also utilized a conlples~ed septum to increase puncture life.
Typical portals are m~nllf~ctured with prerolllled or discrete septums. The portal is assembled by inserting the septum into the housing and then compressing 30 the septum. The septum can be co",p,~ssed either with separate components or by "shoehorning" a larger septum into a housing having an a~t;,lu.~ with a smaller diameter. An example of a portal with a "shoehorned" septum is shown in U.S.
Patent No. 5,045,060 to Melsky et al. A disadvantage of any portal having a preformed septum is increased cost of m~mlf~cture. The increased cost is caused, in 35 part, by the fact that the components used to seal the septum require precise tolerances in their fiim~n~ions.
Another concern with preformed septums compressively sealed against the portal is a decrease in the target area, provided by the septum, to the caregiver. The CA 0222~477 1997-12-22 W O 97101370 PCTrUS96/111D49 target area describes the exposed portion of the septum, through which a needle can access the reservoir. Some prior art portals have aLlcl,lplcd to increase the "target area" ofthe septum available to the caregiver without much success. For example,some of these prior art devices have ~Ll~ Led to increase the target area by S providing integrally molded el~etomeric domes accecsihle from a plurality of F directions. However, the inte~rally molded domes of the prior art have at least t~,vo significant problems. The first problem is that the caregiver is never completely sure when the needle is in the reservoir. For example, the caregiver may push the needle through a side wall and out into the body cavity, believing the needle to be in the reservoir. Second, when pushing the needle into the reservoir the elastomeric dome may collapse, thereby inhibiting injection of any medicant into the reservoir.
Solutions to the problems with domed portals have been proposed by the prior art. An example is an OMEGAPORT brand portal m~n~lf~ctured by Norfollk Medical of Skokie, Illinois. The OMEG~PORT brand portal includes an elastomeric dome which is le;.lrulced by an internal wire cage. The wire cage solves the problem of the dome coll~psing upon insertion of the needle, but provides noindication to the caregiver of when the needle is in the reservoir. Further, the wire cage presents its own problems. These problems include needles deflecting o~f ofthe cage and away from the reservoir.
Therefore, a need has arisen to provide a portal and a method of m~n~ ctl~re which effectively increases the target area of the portal, yet achieves all of the benefits of traditional portals which utilize conl~lcssed septums. Additionally, there is a need to decrease the cost of m~nllf~ctllring portals, including making portals easier to m~nllf~cbure. The portal of the present invention solves these and other problems of the prior art.
Sumnl~ry of the Inve~n The invention includes an implantable portal having a housing and a sepbum.
The housing includes a lumen ~c~ihle through a first open end, and the lumen includes an inner wall. The septum has an outer periphery bonded to the inner wall adjacent the first open end of the housing.
Preferably, the housing further includes an outlet tube assembly operative in accessing the lumen.
Preferably, the septum is injection molded into the lumen of the housing.
c In one implementation, the inner wall of the housing includes a rollghene,~
surface. In other implement~tions, the inner wall of the housing includes a groove.
The inner wall of the housing may include an a&esion promoter thereon.
Preferably, the housing further includes a second open end opposite from the first open end; the second open end includes an associated diameter; and the portal CA 0222~477 l997-l2-22 W O 97/01370 PCTrUS96/11049 further comprises a seal operative to close the second open end of the housing. The seal may include a cup-shaped insert. The cup-shaped insert may be ultrasonically staked to the housing.
Preferably, the septum includes a flanged region, and the cup-shaped insert 5 squeezably engages the flanged region. The septum includes a bottom surface facing the lumen, and the bottom surface may be l-n~ tecl in shape.
In another aspect, the invention includes a method of assembling a portal comprising the steps of providing a housing having a first open end; and injection molding an elastomeric septum in the first open end of the housing.
Preferably, the method further comprises the step of sealing the second end to form a fluid tight reservoir ~qccçssihle through the injection molded septum. The second open end may be sealed with a cup-shaped insert.
Preferably, the method further includes the step of ultrasonically staking the housing to the cup-shaped insert.
The method may include the step of forcing the cup-shaped insert into the second open end of the housing to provide an illLel ~1 ence fit.
In another aspect, the invention includes a portal comprising a septum, an insert, and a housing. The septum includes first and second opposite s~ ces, thesecond surface being un~l--l~te~l The insert engages the septum. The housing holds the septum and the insert.
Preferably, the septum includes a flanged region, and the insert forceably squeezes the flanged region.
In one implementation, the septum is injection molded into the housing. In another implementation, the septum is shoe-horned into the housing.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embo~liment~ of the invention and together with the description, serve to explain the principles of the invention.
BriefD~ lior oftheDrawu~
FIG. 1 is a perspective view of a portal, embodying the present invention;
FIG. 2 is a cross-sectional view of a housing, embodying the present invention;
FIG. 3 is a side plan view of a cup-shaped insert, embodying the present invention;
CA 0222~477 1997-12-22 W O 97/01370 . PCT~US96/11049 FIG. 4 is a cross-sectional plan view of a partially assembled portal positioned in an injection molding fixture according to one ple~ll~,d method of mzlmlf~ccture;
FIG. 5 is a cross-sectional plan view of the partially assembled portal of FIG.
5 1 prior to injection molding;
FIG. 6 is a cross-sectional plan view of a portal including threads adjacent a septum according to another preferred embodiment;
FIG. 7 is a cross-sectional plan view of a partially ~sembled portal in an injection molding fixture according to another pl~r~lled method of m~mlf~ctnre;
FIG. 8 is a cross-sectional plan view of a partially assembled portal, with a septum partially placed therein, according to another ~lt;rell~d method of m~nllf~eture;
FIG. 9 is a cross-sectional plan view of a partially assembled portal, ~ith a septum partially placed therein, according to another pl~re~l~d method of 15 m~nllf~cture;
FIG. 10 is a cross-sectional plan view of a sealed portal according to another ef~ll.,d embodiment;
FIG. 1 1 is the portal of FIG. 10 including an outlet tube assembly;
FIG. 12 is a cross-sectional exploded plan view of a partially assembled 20 portal according to another ~ lled embodiment;
FIG. 13 is a cross-sectional exploded plan view of a partially assembled portal according to another prefell~d embodiment;
FIG. 14 is a cross-sectional exploded plan view of a partially assembled portal according to another preferred embodiment;
FIG. l S is a cross-sectional plan view of a sealed portal according to another pl~:f~led embodiment; and FIG. 16 is a fragmentary cross-sectional view of one region of the porlal of FIG. 15.
nets-iled Description of the Tll~Lstrated ~,~bodi~nents The portal of the present invention includes a septum which is non-collll,lessi~ely held in a housing of a portal. As used herein and as known in lhe art, the term "non-compressively held" means not gripped by compressing across the entire vertical (1imension of the septum. That is, a "colll~Jlessi~ely held" septnm is ~, one which is gripped and squeezed across the entire vertical dimension. The present 35 invention includes a septum which is not squeezed across its entire vertical ~limen~ion. In the first preferred method of the present invention, the septum is injection molded into the housing. It has been found that non-compressively heldseptums provide an increased septum puncture life as compared to compressed CA 0222~477 1997-12-22 W O 97/01370 PCTrUS96/11049 septums. Further, it has been found that an injection molded septum resists "blowout" as well or even better than the compl~sed septums of the prior art. The housing may be sealed in a variety of fashions as to define a sealed reservoir.
In reference to the drawings, in which like elements are numbered alike in S the various figures, the methods and embo-liment~ of the unique portal method of manufacture and portal are shown.
FIG. 1 is a perspective view of an implantable biocompatable access portal 20. Portal 20iS totally implantable within the human body, and permits the infusion of medicants, pd~ L~al solutions, blood products, and other fluids. Portal 20 includes a housing 120 and a septum 122 for l~ceivillg a needle. An outlet tube assembly 150 commlmicates with a hollow inner portion of portal 20, which will be explained below. Outlet tube assembly 150 may be connected with a ç~th~ter in order to deliver medical fluids or the like through a vein in the body.
FIG. 2 illustrates a cross-section of portal housing 120. Portal housing 120 includes a first open end 124 and a second open end 126 having a lumen 127 therebetween. Housing 120 includes an inner wall 123 positioned between first open end 124 and second open end 126. Preferably inner wall 123 has an associated flange 125 portioned between first open end 124 and second open end 126. In a first plerell~d embodiment, both first open end 124 and second open end 126 are circular and include associated diameters.
A cup-shaped insert 130is illustrated in FIG. 3. Cup-shaped insert 130is for eng~ging second open end 126 of portal housing 120. Cup-shaped insert 130is preferably constructed from metal, such as titanium or st~inles~ steel. Insert 130 includes a bottom 132 and a continuous sidewall 134. Sidewall 134 includes an associated diameter which may be slightly greater than the inner diameter of lumen 127 of housing 120. Sidewall 134 includes an associated height. Insert 130 also includes an annular groove 129 positioned on sidewall 134. The various purposes for groove 129 will be explained in more detail below. Shown in phantom is an inner surface 25 of insert 130. Inner surface 25iS for holding the medicant or whatever fluid is being delivered through septum 122 into lumen 127, into tube assembly 150, and ultimately into the patient's body. An outlet 78 extends from sidewall 134 to inner surface 25 to accommodate passage of outlet tube assembly 150.
As shown in FIG. 4, septum 122is injection molded into first open end 124 of housing 120. The injection molding process is described in greater detail below.
Septum 122is positioned against inner wall 123 adjacent first open end 124.
Septum 122is held into housing because of chemical and mechanical bonding forces. More exactly, it is the outer periphery of septum 122 which interacts with CA 0222~477 1997-12-22 WO 97/01370 PCTrUS96/11049 housing 120 to bond septum 122 into first open end 124 of housing 120. The chemical forces are created by adhesives, while the mechanical forces are created by surface irregularities. While the exact chemical forces are not known, these forces are believed to possibly include one or more of the following: covalent bonding;5 pseudo bonding; hydrogen bonding; steric interaction, and; molecular inl. . ,~ gling The mechanical forces describe obstructions to removal of the septum, such as grooves or a roughened surface, which prevent the smooth removal of the seplum.
For example, in the prcr~.-cd embodiment, septum 122 covers flange 125. By covering flange 125, septum 122 is me-h~nic~1ly held into housing 120.
Inner wall 123 of housing 120, which contacts septum 122, may be mechanically altered to create additional connection forces between septum 122 and inner wall 123. For example, and as stated previously, that portion of the inner wall 123 in contact with septum 122 may include a rol~ghene~l surface which improves mechanical adhesion between septum 122 and housing 120. The ro~lghenPd surface may be created by sand or shot blasting, s~nding, r.h~mic~l etchin~, or the equivalent. The improved mechanical connection may also be created by providIng an annular groove 135 in inner wall 123, or a series of annular grooves 135 in inner wall 123 as best shown in FIG. 6. The mechanical techniques increase adhesion because there is more surface contact between septum 122 and inner wall 123.
Further, the uneven surface created by the above increases the "grip" of the injected molded septum on the housing, which improves axial adhesion.
The adhesion between inner wall 123 and septum 122 is created by treating the inner wall 123 of housing 122 with an adhesion promoter. An example of an acceptable adhesion promoter is sold under the tr~d~rn~rk CHEM-LOK 608, by Lord Elastomer Products, located in Erie, PA. The active ingredient in CHEM-LOK 608 adhesion promoter is silane. This adhesion promoter works equally well with bo~hmetallic and non-metallic housings. The adhesion promoter creates a chemical bond between the elastomeric and itself.
Septum 122 may be injection molded in a variety of f~hions, as best illustrated in FIGS. 4, 5 and 7. As illustrated in FIGS. 4 and 5, housing 120 isplaced on fixture 114 so that second open end 126 of housing 120 is positioned on a core pin 116. Core pin 116 extends through fixture base 114 into lumen 127 of housing 120, and includes a passage 112 operative in delivering an elastomeric material which will form septum 122. An example of a suitable elastomeric material is silicone. An upper mold piece 110 engages housing 120 proximate first open end 124 to define an upper surface of septum 122. In the injection molding process, the elastomeric material may flow out beyond upper mold piece 110. This will cause aflash which may be trimmed later in the process.
CA 0222~477 l997-l2-22 W O 97/01370 PCT~US96/11049 With continued reference to FIG. 5, upper mold piece 110 defines the outer features of septum 122, while core pin 116 defines the inner fe~lu,es of sept~m 122.
Passage 112 could be positioned on either upper mold 110 or core pin 116, however, positioning passage 112 in core pin 116 is ~ r~llcd so that the outer surface of5 septum 122 does not include any gate vestige. Gate vestige describes an excess of elastomeric m~ten~l which is deposited ~dj~ nt passage 112. After injection, theelastomeric material will cure to provide a pierceable septum. Elastomeric materials other than silicone may also be used to construct the septum.
After the elastomeric m~t~ri~l has cured, upper mold piece 110 of FIGS. 4 and 5 may be removed and housing 120 and septum 122 may be ~li.cçng~ged from fixture 114 and core pin 116. Any flash may then be trimmed. The portion of lumen 127 of housing 120 adjacent core pin 116 will define a reservoir 140 operable to receive liquid ph~rm~ceuticals, or medicants. Second open end 126 of housing 120 may be sealed in a variety of fashions as will be described in greater detail - 15 hereinafter.
A second preferred method of injection molding the septum of a portal is illustrated in FIG. 7. The second plercLl~ d method also provides a technique toinjection mold a septum into a housing. The second l,lc;rt;ll~d method elimin~tes the need for upper mold piece 110. Specifically, a lower mold 214 is provided which defines the outer characteristics of septum 122, while a core pin 216 delivers the elastomeric material through a passage 212.
In either of the injection molding methods illustrated in FIGS. 4 and 5 or FIG. 7, the elastomeric material can be injected through core pin 116 or upper mold piece 110 as shown in FIG. 4, or core pin 216 or lower mold 214 as in FIG. 7.
However, in either embodiment, it is preferred to inject from the reservoir side of the septum. This is plefelled because any gate vestige will not be readily al~palelll to the user.
Injection molding is one method of rn~m-f~(~turing a portal according to the present invention. Other techniques or methods are also contemplated. For example, as shown in FIGS. 8 and 9, a septum may be held in the first open end of the housing only by an adhesion promoter. FIGS. 8 and 9 illustrate a preformed septum 225 having outer dimensions the same as or smaller than first open end 124.
Inner wall 123 is treated with an adhesion promoter, such as CHEM-LOK 608 and then septum 225 may be shoehorned in as shown in FIG. 8 or dropped in as shown in FIG. 9. Septum 225 will then be bonded to housing 120 with the adhesion promoter only and not through any compressive forces on septum 225. The injection molding process in addition to the methods shown in FIGS. 8 and 9 are considered to be non-conlpLes~ive because neither housing 120, nor any other CA 0222~477 1997-12-22 W O 97/01370 PCT~US96/11~i49 co~ )oll~ , exert forces across the entire vertical ~imen~ion of the septum to seal it in the open end of the housing. An example of a c~ ;s~ ely held septum is shown in U.S. Patent No. 5,387,192, to Glantz et al., the specification and drawings of which are herein incorporated by reference.
After septum 122 has been injected molded, or otherwise inserted into first open end 124 of housing 120, second open end 126 is sealed to define a reser~oir140 ~ces~ihle through septum 122. FIGS. 10-14 illustrate di~,lent ways in which second open end 126 of housing 120 may be sealed. These examples are not inten-l~cl to be limiting, but rather only exemplify a few the many possible techniques available to seal second open end 126 of housing 120.
With reference to FIGS. 10 and 11 there is shown housing 120 with septum 122. In this specific embodiment, housing 120 of the portal as shown in FIGS. 10and 11 is of a non-metallic, plastic construction, such as polysulfone. Second open end 126 is shown eng~ging cup-shaped insert 130. In this particular embodin:lent, the associated height of cup-shaped insert 130 is not great enough to contact sep~um 122 when bottom 132 of cup-shaped insert 130 is flush with the bottom of the housing 120. That is, a gap 137 exists ~ Lweel~ cup-shaped insert 130 and sep~tum 122.
The portal of FIGS. 10 and 11 is assembled by ultrasonically staking metallic cup-shaped insert 130 to non-metallic housing 120. Specifically, cup-shaped insert 130 is ultrasonically vibrated and simultaneously forced into the lumen of housirlg 120. Vibrating cup-shaped insert 130 melts the plastic of housing 120 as it is forced therein. The melted plastic is pushed, by cup-shaped insert 130 into an annular groove 129 positioned on side wall 134 of cup-shaped insert. Further, the plastic from housing 120 is pushed into gap 137 between cup-shaped insert 130 and septum122. Cup-shaped insert 130 is no longerpushed into lumen 127 of housing 1,'0 when bottom 132 of cup-shaped insert 130 is flush with the bottom of housing 120.
FIG. 11 illustrates the portal of FIG. 10 with outlet tube assembly 150 Outlet tube assembly 150 may be of any type including, but not limited to, that illustrated in FIG. 11. The outlet tube assembly of FIG. 11 could be used with any of the portals illustrated in FIGS. 12-14.
- FIG. 12 illustrates a second embodiment of sealing second open end 126 of housing 120. In particular, cup-shaped 130 insert includes two diameters, a diameter smaller than the diameter of second open end 126 above groove 129 and a diameterlarger than the diameter of second open end 126 below groove 129. In this particular arrangement, the height of wall 134 is not great enough to contact septum 122. The smaller diameter above annular groove 129 helps to center cup-shaped insert 130 in lumen 127 of housing 120. A non-metallic ring 131, preferably CA 0222~477 l997-l2-22 W O 97/01370 .. PCTrUS96/11049 constructed from plastic such as polysulfone is also included. Ring 131 is positioned between the upper rim of cup-shaped insert 130 and septum 122. Cup-shaped insert 130 is ultrasonically staked into housing such that housing 120 ismelted into annular groove 129. As cup-shaped insert 130 is forced into lumen 127 of housing 120, ring 131 is pushed into contact with septum 122. Ring 131 does not exert compression across the entire vertical dimension of the septum. As such, septum 122 is non-compressively held in housing 120.
While the ultrasonic staking technique illustrated in FIGS. 10-12 is preferred, cup-shaped insert 130 may be bonded to housing 120 in a variety of other ways aswell. These ways include mechanical and chemical techniques. For example, in thecase of an all metal housing, an all metal cup-shaped insert may engage second open end and seal housing 120 through an hl~ llce fit. Specifically, the cup-shaped insert would include an outer diameter slightly larger than the diameter of second open end 126, and the cup-shaped insert would be forced into the second open endas described in U.S. Patent No. 5,387,192. For example, according to the presentinvention, the septum of U.S. Patent No. 5,387,192 may be injection molded. Other methods of m~h~nical connection between the cup-shaped insert 130 and housing 120 could include threading the interior of lumen 127 of housing 120 and the exterior of the cup-shaped insert 130 for engagement between cup-shaped insert 130 and housing 120. Cup-shaped 130 insert could also be chemically bonded to housing 120, through the use of adhesives.
A disadvantage of using a cup-shaped insert which extends toward the septum is far field forces during the assembly process. Far field forces describe a substantial difference in location between where energy is applied and where force is exerted. For example, in the case of assembling a portal including a cup-shaped insert, when the cup-shaped insert is pushed into the housing the energy will beapplied to the bottom of the insert but, the result~nt force exerted by the insert against the housing is located at the top of the side wall of the insert.
Problems associated with far field forces may be significantly decreased if far field forces are turned into near field forces. Near field forces describe the situation when the resultant forces are close to the source of energy. Near field forces may be obtained by using a planar member to seal the second open end of the housmg.
As illustrated in FIGS. 13 and 14, second open end 126 of housing 120 may be sealed with a planar member such as a disc 230. When using disc 230 to seal second open end 126, the energy-force relationship results in near field forces. In addition to disc 230 providing near field forces, significant expense is saved because disc 230 is constructed from a decreased volume of materials.
CA 0222~477 1997-12-22 wo 97/01370 PCT/US96/1lO49 The prior art did not utilize discs to create sealed reservoirs because discs fail to provide sllfficient force necessary to CO~ ;7s the septum. Disc 230 can be ~tt~ch~l into second open end 126 in a variet,v of ways. These ways include ultrasonic welding, ultrasonic st~kin~, screwing, ~..a~,;..g or bonding together v~iith S a&esives.
FIG. 13 shows a housing 120 having a septum 122 positioned in a first open end 124. Second open end 126 of housing 120 also includes a shelf 228. Shelf ~!28 operates to receive a disc 230. Disc 230 may be sealed onto shelf 228 through ultrasonic welding, snaps, threads, adhesives, or using other techniques knowll in the 10 art.
As illustrated in FIG. 14, housing 220 may also include a plurality of flaps 240 which may be folded onto disc 230. Flaps 240 capture disc 230, and provide pressure between disc 230 and shelf 228.
~ nother p.~ r~,..ed arrangement is illustrated in FIGS. l 5 and 16. FIG. l 5 is a cross-sectional view of the complete portal assembly. In this particular ~.ef~ darrangement, the associated height of insert 130 is great enough to contact septurn l 22 and squeeze a flanged region 30 of septum 122. The mechanical force of the squeeze on flanged region 30 by insert l 30 is so great that it reduces the original width of flanged region 30 by about two-thirds. It is believed that the pressure om flanged region 30 by insert 130 is so great that it creates a wavy, or lm~ t.o~
surface 35 across a bottom of septum 122. It was discovered that this wavy surface 35 results in unexpected advantages. Specifically, it was discovered that the number of needle punctures sllst~ine~l by septum 122 before leakage increased significantly.
For example, in the embodiment illustrated in FIG. l l, insert 130 does not touch septum l 22. In the FIG. l l embodiment, the number of needle punctures before failure was about 1,200 to 1,500 sticks. It was discovered that in the FIG. l 5 embodiment, by colllple;7~ g flanged region 30 of septum l22 by insert l30, septum l22 can sustain up to 3,000 needle sticks before failure.
FIG. l6 illustrates in greater detail 130 co-..~ ing flanged region 30 of septum l22. Also illustrated in FIG. l6 is the portion 35 of housing l20 whic]h is melted by ultrasonic staking solidified into annular ring l29 of insert l30. As explained above, this helps securely contain insert 130 into housing 120.
Septum l22 in the embo-iiment~ of FIGS. l 5 and l6 is preferably injection molded into housing 120 in a non-compressive manner, as explained above. Prior to inserting cup-shaped insert l30, the bottom portion of septum 122 is flat and straight. That is, the wavy, or undulated, surface 35 of septum 122 is not crealed until insert 130 is compressed against flanged region 30. Septum 122 is non-compressively held in housing l20 because it is not compressed across the entire CA 0222~477 1997-12-22 W O 97/01370 PCT~US96/11049 vertical ~1imension of septum 122. The co~ lcs~ion on flanged region 30 by insert 130 is only across the vertical rlimencion of the flanged region 30, and not across the entire vertical (limen~ion of septum 122.
It will be appreciated that the present invention may be used with any 5 combination of plastic and metal. Specifically, the housing may be of plastic or metallic construction. As explained above, dirr.,l~l~t adhesion enh~n~lonnent techniques may be used with metallic and non-metallic housings.
The present invention has significant advantages over the prior art. These advantages included decreased cost of m~nllf~rtllring, increased puncture life and 10 increased resi~t~nce to blowout. Further, because the septum is injection molded, design tolerances of m~nnf~cture may be greater also decreasing expense.
While the foregoing detailed description of the present invention describes the preferred embotliment~, it will be appreciated that it is the intent of the inventors to include all modification and equivalent cleqign~ Accordingly, the scope of the 15 present invention is intended to be limited only by the claims which are appended hereto.
,
,, R~ roun~
Access portals provide a convenient method to repeatedly deliver meclic~nt~
to remote areas of the body without lltili~in~ surgical procedures. Portals are totally 10 implantable within the body, i.e. subcutaneous, and permit the infusion of medicants, pal~,..Leldl solutions, blood products, and other fluids. Portals may alio be used for blood sampling.
A typical portal generally includes a housing assembly, a septum, and an outlet. The housing assembly and septum define a reservoir which is ~cces~il sle15 through the septum. The outlet includes or is ~tt~ched to a c~thtoter which ~cçsses a vein. The cath~-ter delivers fluid from the portal to a remote location in the body, for example the superior vena cava. The outlet may be an integral c~th~ter as in IJ.S.
Patent No. 4,471,885 to Weeks, or a separate metallic outlet tube assembly as inU.S. Patent No. 5,213,574 to Tucker. In the case of a portal with an outlet tube20 assembly, a catheter will be attached thereto.
In common practice, the portal is implanted within the body and the ç~lth~-ter is routed to a remote area were fluid is desired to be delivered. To deliver the fluid, a caregiver locates the septurn of the portal by palpation of the patient's skin. Portal access is accomplished by percutaneously inserting a needle, typically a non-coring 25 needle, perpendicularly through the septum of the portal and into the reservoir. 'rhe drug or medicant is then a-lmini~tered by bolus injection or continuous infusion.
Ordinarily, the fluid flows through the reservoir into the catheter and finally to the site were the fluid is desired.
Portals generally come in two difr~ L types, surgical and cosmetic.
30 Surgical portals are used to deliver medicants, including chemotherapy drugs which may be harmful to surrounding tissue, as well as sampling blood. Cosmetic port~als, on the other hand, are utilized to deliver saline or some other non-reactive substamce to a prosthesis which supplements a body feature. An example of a surgical port;al is shown in U.S. Patent No. 5,213,574, while an example of a cosmetic portal is shown 35 in U.S. Patent No. 4,471,885.
A concern for all portals, and especially portals used for surgical procedures, is blowout. Blowout describes the catastrophic failure of a portal when the ~.es~ule inside the reservoir is great enough to ~ n~ge the septum from the housing of the CA 0222~477 1997-12-22 W O 97/01370 PCTrUS96/11049 portal. Disengagement of the septum may injure the patient, and release medication contained in the portal. The released medicant will often be harmful to the surrounding tissue. Blowouts have a variety of causes. For example, a blowout may be caused if the catheter downstream of the portal is occluded and a bolus injection is attempted. When the bolus injection is attempted the injected fluid cannot travel through the catheter and as fluid is contin~ ly injected into the reservoir of the portal the l,ie~ e increases until the septum is disengaged.
Blowouts are of a much greater concern for surgical portals than for cosmetic portals. A ~lilll~ reason for this is that the reservoirs of surgical portals often 10 contain caustic medicants while the reservoirs of cosmetic portals do not. Toprevent blowout, surgical portals typically hold the septum in the housing of the portal under great compression. For example, the SIMS Deltec PORT-A-CATH
brand portal uses an i"lelre~ence fit to both radially and axially compress the septum to hold it in place.
In contrast, some cosmetic portals, for example, the portal shown in U.S.
Patent No. 4,371,885, are sealed to the housing by collll)les~illg only a preformed ridge around the septum with, for example, a threaded ring. The threaded ring ofU.S. Patent No. 4,371,885 does not provide as much com~,es~ive force as the PORT-A-CATH portal.
Another concern with porta,ls, and more importantly with surgical portals, is puncture life. Puncture life describes the number of punctures a septum can resist and still provide a fluid tight seal. If the septum does not reseal after an injection is made, the injected medicant may leak out of the reservoir and possibly harm the surrounding tissue. Once again, septum life is of greater importance in surgical25 portals than cosmetic portals because of the nature of the medicant being injected.
Commercially successful prior art surgical portals have also utilized a conlples~ed septum to increase puncture life.
Typical portals are m~nllf~ctured with prerolllled or discrete septums. The portal is assembled by inserting the septum into the housing and then compressing 30 the septum. The septum can be co",p,~ssed either with separate components or by "shoehorning" a larger septum into a housing having an a~t;,lu.~ with a smaller diameter. An example of a portal with a "shoehorned" septum is shown in U.S.
Patent No. 5,045,060 to Melsky et al. A disadvantage of any portal having a preformed septum is increased cost of m~mlf~cture. The increased cost is caused, in 35 part, by the fact that the components used to seal the septum require precise tolerances in their fiim~n~ions.
Another concern with preformed septums compressively sealed against the portal is a decrease in the target area, provided by the septum, to the caregiver. The CA 0222~477 1997-12-22 W O 97101370 PCTrUS96/111D49 target area describes the exposed portion of the septum, through which a needle can access the reservoir. Some prior art portals have aLlcl,lplcd to increase the "target area" ofthe septum available to the caregiver without much success. For example,some of these prior art devices have ~Ll~ Led to increase the target area by S providing integrally molded el~etomeric domes accecsihle from a plurality of F directions. However, the inte~rally molded domes of the prior art have at least t~,vo significant problems. The first problem is that the caregiver is never completely sure when the needle is in the reservoir. For example, the caregiver may push the needle through a side wall and out into the body cavity, believing the needle to be in the reservoir. Second, when pushing the needle into the reservoir the elastomeric dome may collapse, thereby inhibiting injection of any medicant into the reservoir.
Solutions to the problems with domed portals have been proposed by the prior art. An example is an OMEGAPORT brand portal m~n~lf~ctured by Norfollk Medical of Skokie, Illinois. The OMEG~PORT brand portal includes an elastomeric dome which is le;.lrulced by an internal wire cage. The wire cage solves the problem of the dome coll~psing upon insertion of the needle, but provides noindication to the caregiver of when the needle is in the reservoir. Further, the wire cage presents its own problems. These problems include needles deflecting o~f ofthe cage and away from the reservoir.
Therefore, a need has arisen to provide a portal and a method of m~n~ ctl~re which effectively increases the target area of the portal, yet achieves all of the benefits of traditional portals which utilize conl~lcssed septums. Additionally, there is a need to decrease the cost of m~nllf~ctllring portals, including making portals easier to m~nllf~cbure. The portal of the present invention solves these and other problems of the prior art.
Sumnl~ry of the Inve~n The invention includes an implantable portal having a housing and a sepbum.
The housing includes a lumen ~c~ihle through a first open end, and the lumen includes an inner wall. The septum has an outer periphery bonded to the inner wall adjacent the first open end of the housing.
Preferably, the housing further includes an outlet tube assembly operative in accessing the lumen.
Preferably, the septum is injection molded into the lumen of the housing.
c In one implementation, the inner wall of the housing includes a rollghene,~
surface. In other implement~tions, the inner wall of the housing includes a groove.
The inner wall of the housing may include an a&esion promoter thereon.
Preferably, the housing further includes a second open end opposite from the first open end; the second open end includes an associated diameter; and the portal CA 0222~477 l997-l2-22 W O 97/01370 PCTrUS96/11049 further comprises a seal operative to close the second open end of the housing. The seal may include a cup-shaped insert. The cup-shaped insert may be ultrasonically staked to the housing.
Preferably, the septum includes a flanged region, and the cup-shaped insert 5 squeezably engages the flanged region. The septum includes a bottom surface facing the lumen, and the bottom surface may be l-n~ tecl in shape.
In another aspect, the invention includes a method of assembling a portal comprising the steps of providing a housing having a first open end; and injection molding an elastomeric septum in the first open end of the housing.
Preferably, the method further comprises the step of sealing the second end to form a fluid tight reservoir ~qccçssihle through the injection molded septum. The second open end may be sealed with a cup-shaped insert.
Preferably, the method further includes the step of ultrasonically staking the housing to the cup-shaped insert.
The method may include the step of forcing the cup-shaped insert into the second open end of the housing to provide an illLel ~1 ence fit.
In another aspect, the invention includes a portal comprising a septum, an insert, and a housing. The septum includes first and second opposite s~ ces, thesecond surface being un~l--l~te~l The insert engages the septum. The housing holds the septum and the insert.
Preferably, the septum includes a flanged region, and the insert forceably squeezes the flanged region.
In one implementation, the septum is injection molded into the housing. In another implementation, the septum is shoe-horned into the housing.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embo~liment~ of the invention and together with the description, serve to explain the principles of the invention.
BriefD~ lior oftheDrawu~
FIG. 1 is a perspective view of a portal, embodying the present invention;
FIG. 2 is a cross-sectional view of a housing, embodying the present invention;
FIG. 3 is a side plan view of a cup-shaped insert, embodying the present invention;
CA 0222~477 1997-12-22 W O 97/01370 . PCT~US96/11049 FIG. 4 is a cross-sectional plan view of a partially assembled portal positioned in an injection molding fixture according to one ple~ll~,d method of mzlmlf~ccture;
FIG. 5 is a cross-sectional plan view of the partially assembled portal of FIG.
5 1 prior to injection molding;
FIG. 6 is a cross-sectional plan view of a portal including threads adjacent a septum according to another preferred embodiment;
FIG. 7 is a cross-sectional plan view of a partially ~sembled portal in an injection molding fixture according to another pl~r~lled method of m~mlf~ctnre;
FIG. 8 is a cross-sectional plan view of a partially assembled portal, with a septum partially placed therein, according to another ~lt;rell~d method of m~nllf~eture;
FIG. 9 is a cross-sectional plan view of a partially assembled portal, ~ith a septum partially placed therein, according to another pl~re~l~d method of 15 m~nllf~cture;
FIG. 10 is a cross-sectional plan view of a sealed portal according to another ef~ll.,d embodiment;
FIG. 1 1 is the portal of FIG. 10 including an outlet tube assembly;
FIG. 12 is a cross-sectional exploded plan view of a partially assembled 20 portal according to another ~ lled embodiment;
FIG. 13 is a cross-sectional exploded plan view of a partially assembled portal according to another prefell~d embodiment;
FIG. 14 is a cross-sectional exploded plan view of a partially assembled portal according to another preferred embodiment;
FIG. l S is a cross-sectional plan view of a sealed portal according to another pl~:f~led embodiment; and FIG. 16 is a fragmentary cross-sectional view of one region of the porlal of FIG. 15.
nets-iled Description of the Tll~Lstrated ~,~bodi~nents The portal of the present invention includes a septum which is non-collll,lessi~ely held in a housing of a portal. As used herein and as known in lhe art, the term "non-compressively held" means not gripped by compressing across the entire vertical (1imension of the septum. That is, a "colll~Jlessi~ely held" septnm is ~, one which is gripped and squeezed across the entire vertical dimension. The present 35 invention includes a septum which is not squeezed across its entire vertical ~limen~ion. In the first preferred method of the present invention, the septum is injection molded into the housing. It has been found that non-compressively heldseptums provide an increased septum puncture life as compared to compressed CA 0222~477 1997-12-22 W O 97/01370 PCTrUS96/11049 septums. Further, it has been found that an injection molded septum resists "blowout" as well or even better than the compl~sed septums of the prior art. The housing may be sealed in a variety of fashions as to define a sealed reservoir.
In reference to the drawings, in which like elements are numbered alike in S the various figures, the methods and embo-liment~ of the unique portal method of manufacture and portal are shown.
FIG. 1 is a perspective view of an implantable biocompatable access portal 20. Portal 20iS totally implantable within the human body, and permits the infusion of medicants, pd~ L~al solutions, blood products, and other fluids. Portal 20 includes a housing 120 and a septum 122 for l~ceivillg a needle. An outlet tube assembly 150 commlmicates with a hollow inner portion of portal 20, which will be explained below. Outlet tube assembly 150 may be connected with a ç~th~ter in order to deliver medical fluids or the like through a vein in the body.
FIG. 2 illustrates a cross-section of portal housing 120. Portal housing 120 includes a first open end 124 and a second open end 126 having a lumen 127 therebetween. Housing 120 includes an inner wall 123 positioned between first open end 124 and second open end 126. Preferably inner wall 123 has an associated flange 125 portioned between first open end 124 and second open end 126. In a first plerell~d embodiment, both first open end 124 and second open end 126 are circular and include associated diameters.
A cup-shaped insert 130is illustrated in FIG. 3. Cup-shaped insert 130is for eng~ging second open end 126 of portal housing 120. Cup-shaped insert 130is preferably constructed from metal, such as titanium or st~inles~ steel. Insert 130 includes a bottom 132 and a continuous sidewall 134. Sidewall 134 includes an associated diameter which may be slightly greater than the inner diameter of lumen 127 of housing 120. Sidewall 134 includes an associated height. Insert 130 also includes an annular groove 129 positioned on sidewall 134. The various purposes for groove 129 will be explained in more detail below. Shown in phantom is an inner surface 25 of insert 130. Inner surface 25iS for holding the medicant or whatever fluid is being delivered through septum 122 into lumen 127, into tube assembly 150, and ultimately into the patient's body. An outlet 78 extends from sidewall 134 to inner surface 25 to accommodate passage of outlet tube assembly 150.
As shown in FIG. 4, septum 122is injection molded into first open end 124 of housing 120. The injection molding process is described in greater detail below.
Septum 122is positioned against inner wall 123 adjacent first open end 124.
Septum 122is held into housing because of chemical and mechanical bonding forces. More exactly, it is the outer periphery of septum 122 which interacts with CA 0222~477 1997-12-22 WO 97/01370 PCTrUS96/11049 housing 120 to bond septum 122 into first open end 124 of housing 120. The chemical forces are created by adhesives, while the mechanical forces are created by surface irregularities. While the exact chemical forces are not known, these forces are believed to possibly include one or more of the following: covalent bonding;5 pseudo bonding; hydrogen bonding; steric interaction, and; molecular inl. . ,~ gling The mechanical forces describe obstructions to removal of the septum, such as grooves or a roughened surface, which prevent the smooth removal of the seplum.
For example, in the prcr~.-cd embodiment, septum 122 covers flange 125. By covering flange 125, septum 122 is me-h~nic~1ly held into housing 120.
Inner wall 123 of housing 120, which contacts septum 122, may be mechanically altered to create additional connection forces between septum 122 and inner wall 123. For example, and as stated previously, that portion of the inner wall 123 in contact with septum 122 may include a rol~ghene~l surface which improves mechanical adhesion between septum 122 and housing 120. The ro~lghenPd surface may be created by sand or shot blasting, s~nding, r.h~mic~l etchin~, or the equivalent. The improved mechanical connection may also be created by providIng an annular groove 135 in inner wall 123, or a series of annular grooves 135 in inner wall 123 as best shown in FIG. 6. The mechanical techniques increase adhesion because there is more surface contact between septum 122 and inner wall 123.
Further, the uneven surface created by the above increases the "grip" of the injected molded septum on the housing, which improves axial adhesion.
The adhesion between inner wall 123 and septum 122 is created by treating the inner wall 123 of housing 122 with an adhesion promoter. An example of an acceptable adhesion promoter is sold under the tr~d~rn~rk CHEM-LOK 608, by Lord Elastomer Products, located in Erie, PA. The active ingredient in CHEM-LOK 608 adhesion promoter is silane. This adhesion promoter works equally well with bo~hmetallic and non-metallic housings. The adhesion promoter creates a chemical bond between the elastomeric and itself.
Septum 122 may be injection molded in a variety of f~hions, as best illustrated in FIGS. 4, 5 and 7. As illustrated in FIGS. 4 and 5, housing 120 isplaced on fixture 114 so that second open end 126 of housing 120 is positioned on a core pin 116. Core pin 116 extends through fixture base 114 into lumen 127 of housing 120, and includes a passage 112 operative in delivering an elastomeric material which will form septum 122. An example of a suitable elastomeric material is silicone. An upper mold piece 110 engages housing 120 proximate first open end 124 to define an upper surface of septum 122. In the injection molding process, the elastomeric material may flow out beyond upper mold piece 110. This will cause aflash which may be trimmed later in the process.
CA 0222~477 l997-l2-22 W O 97/01370 PCT~US96/11049 With continued reference to FIG. 5, upper mold piece 110 defines the outer features of septum 122, while core pin 116 defines the inner fe~lu,es of sept~m 122.
Passage 112 could be positioned on either upper mold 110 or core pin 116, however, positioning passage 112 in core pin 116 is ~ r~llcd so that the outer surface of5 septum 122 does not include any gate vestige. Gate vestige describes an excess of elastomeric m~ten~l which is deposited ~dj~ nt passage 112. After injection, theelastomeric material will cure to provide a pierceable septum. Elastomeric materials other than silicone may also be used to construct the septum.
After the elastomeric m~t~ri~l has cured, upper mold piece 110 of FIGS. 4 and 5 may be removed and housing 120 and septum 122 may be ~li.cçng~ged from fixture 114 and core pin 116. Any flash may then be trimmed. The portion of lumen 127 of housing 120 adjacent core pin 116 will define a reservoir 140 operable to receive liquid ph~rm~ceuticals, or medicants. Second open end 126 of housing 120 may be sealed in a variety of fashions as will be described in greater detail - 15 hereinafter.
A second preferred method of injection molding the septum of a portal is illustrated in FIG. 7. The second plercLl~ d method also provides a technique toinjection mold a septum into a housing. The second l,lc;rt;ll~d method elimin~tes the need for upper mold piece 110. Specifically, a lower mold 214 is provided which defines the outer characteristics of septum 122, while a core pin 216 delivers the elastomeric material through a passage 212.
In either of the injection molding methods illustrated in FIGS. 4 and 5 or FIG. 7, the elastomeric material can be injected through core pin 116 or upper mold piece 110 as shown in FIG. 4, or core pin 216 or lower mold 214 as in FIG. 7.
However, in either embodiment, it is preferred to inject from the reservoir side of the septum. This is plefelled because any gate vestige will not be readily al~palelll to the user.
Injection molding is one method of rn~m-f~(~turing a portal according to the present invention. Other techniques or methods are also contemplated. For example, as shown in FIGS. 8 and 9, a septum may be held in the first open end of the housing only by an adhesion promoter. FIGS. 8 and 9 illustrate a preformed septum 225 having outer dimensions the same as or smaller than first open end 124.
Inner wall 123 is treated with an adhesion promoter, such as CHEM-LOK 608 and then septum 225 may be shoehorned in as shown in FIG. 8 or dropped in as shown in FIG. 9. Septum 225 will then be bonded to housing 120 with the adhesion promoter only and not through any compressive forces on septum 225. The injection molding process in addition to the methods shown in FIGS. 8 and 9 are considered to be non-conlpLes~ive because neither housing 120, nor any other CA 0222~477 1997-12-22 W O 97/01370 PCT~US96/11~i49 co~ )oll~ , exert forces across the entire vertical ~imen~ion of the septum to seal it in the open end of the housing. An example of a c~ ;s~ ely held septum is shown in U.S. Patent No. 5,387,192, to Glantz et al., the specification and drawings of which are herein incorporated by reference.
After septum 122 has been injected molded, or otherwise inserted into first open end 124 of housing 120, second open end 126 is sealed to define a reser~oir140 ~ces~ihle through septum 122. FIGS. 10-14 illustrate di~,lent ways in which second open end 126 of housing 120 may be sealed. These examples are not inten-l~cl to be limiting, but rather only exemplify a few the many possible techniques available to seal second open end 126 of housing 120.
With reference to FIGS. 10 and 11 there is shown housing 120 with septum 122. In this specific embodiment, housing 120 of the portal as shown in FIGS. 10and 11 is of a non-metallic, plastic construction, such as polysulfone. Second open end 126 is shown eng~ging cup-shaped insert 130. In this particular embodin:lent, the associated height of cup-shaped insert 130 is not great enough to contact sep~um 122 when bottom 132 of cup-shaped insert 130 is flush with the bottom of the housing 120. That is, a gap 137 exists ~ Lweel~ cup-shaped insert 130 and sep~tum 122.
The portal of FIGS. 10 and 11 is assembled by ultrasonically staking metallic cup-shaped insert 130 to non-metallic housing 120. Specifically, cup-shaped insert 130 is ultrasonically vibrated and simultaneously forced into the lumen of housirlg 120. Vibrating cup-shaped insert 130 melts the plastic of housing 120 as it is forced therein. The melted plastic is pushed, by cup-shaped insert 130 into an annular groove 129 positioned on side wall 134 of cup-shaped insert. Further, the plastic from housing 120 is pushed into gap 137 between cup-shaped insert 130 and septum122. Cup-shaped insert 130 is no longerpushed into lumen 127 of housing 1,'0 when bottom 132 of cup-shaped insert 130 is flush with the bottom of housing 120.
FIG. 11 illustrates the portal of FIG. 10 with outlet tube assembly 150 Outlet tube assembly 150 may be of any type including, but not limited to, that illustrated in FIG. 11. The outlet tube assembly of FIG. 11 could be used with any of the portals illustrated in FIGS. 12-14.
- FIG. 12 illustrates a second embodiment of sealing second open end 126 of housing 120. In particular, cup-shaped 130 insert includes two diameters, a diameter smaller than the diameter of second open end 126 above groove 129 and a diameterlarger than the diameter of second open end 126 below groove 129. In this particular arrangement, the height of wall 134 is not great enough to contact septum 122. The smaller diameter above annular groove 129 helps to center cup-shaped insert 130 in lumen 127 of housing 120. A non-metallic ring 131, preferably CA 0222~477 l997-l2-22 W O 97/01370 .. PCTrUS96/11049 constructed from plastic such as polysulfone is also included. Ring 131 is positioned between the upper rim of cup-shaped insert 130 and septum 122. Cup-shaped insert 130 is ultrasonically staked into housing such that housing 120 ismelted into annular groove 129. As cup-shaped insert 130 is forced into lumen 127 of housing 120, ring 131 is pushed into contact with septum 122. Ring 131 does not exert compression across the entire vertical dimension of the septum. As such, septum 122 is non-compressively held in housing 120.
While the ultrasonic staking technique illustrated in FIGS. 10-12 is preferred, cup-shaped insert 130 may be bonded to housing 120 in a variety of other ways aswell. These ways include mechanical and chemical techniques. For example, in thecase of an all metal housing, an all metal cup-shaped insert may engage second open end and seal housing 120 through an hl~ llce fit. Specifically, the cup-shaped insert would include an outer diameter slightly larger than the diameter of second open end 126, and the cup-shaped insert would be forced into the second open endas described in U.S. Patent No. 5,387,192. For example, according to the presentinvention, the septum of U.S. Patent No. 5,387,192 may be injection molded. Other methods of m~h~nical connection between the cup-shaped insert 130 and housing 120 could include threading the interior of lumen 127 of housing 120 and the exterior of the cup-shaped insert 130 for engagement between cup-shaped insert 130 and housing 120. Cup-shaped 130 insert could also be chemically bonded to housing 120, through the use of adhesives.
A disadvantage of using a cup-shaped insert which extends toward the septum is far field forces during the assembly process. Far field forces describe a substantial difference in location between where energy is applied and where force is exerted. For example, in the case of assembling a portal including a cup-shaped insert, when the cup-shaped insert is pushed into the housing the energy will beapplied to the bottom of the insert but, the result~nt force exerted by the insert against the housing is located at the top of the side wall of the insert.
Problems associated with far field forces may be significantly decreased if far field forces are turned into near field forces. Near field forces describe the situation when the resultant forces are close to the source of energy. Near field forces may be obtained by using a planar member to seal the second open end of the housmg.
As illustrated in FIGS. 13 and 14, second open end 126 of housing 120 may be sealed with a planar member such as a disc 230. When using disc 230 to seal second open end 126, the energy-force relationship results in near field forces. In addition to disc 230 providing near field forces, significant expense is saved because disc 230 is constructed from a decreased volume of materials.
CA 0222~477 1997-12-22 wo 97/01370 PCT/US96/1lO49 The prior art did not utilize discs to create sealed reservoirs because discs fail to provide sllfficient force necessary to CO~ ;7s the septum. Disc 230 can be ~tt~ch~l into second open end 126 in a variet,v of ways. These ways include ultrasonic welding, ultrasonic st~kin~, screwing, ~..a~,;..g or bonding together v~iith S a&esives.
FIG. 13 shows a housing 120 having a septum 122 positioned in a first open end 124. Second open end 126 of housing 120 also includes a shelf 228. Shelf ~!28 operates to receive a disc 230. Disc 230 may be sealed onto shelf 228 through ultrasonic welding, snaps, threads, adhesives, or using other techniques knowll in the 10 art.
As illustrated in FIG. 14, housing 220 may also include a plurality of flaps 240 which may be folded onto disc 230. Flaps 240 capture disc 230, and provide pressure between disc 230 and shelf 228.
~ nother p.~ r~,..ed arrangement is illustrated in FIGS. l 5 and 16. FIG. l 5 is a cross-sectional view of the complete portal assembly. In this particular ~.ef~ darrangement, the associated height of insert 130 is great enough to contact septurn l 22 and squeeze a flanged region 30 of septum 122. The mechanical force of the squeeze on flanged region 30 by insert l 30 is so great that it reduces the original width of flanged region 30 by about two-thirds. It is believed that the pressure om flanged region 30 by insert 130 is so great that it creates a wavy, or lm~ t.o~
surface 35 across a bottom of septum 122. It was discovered that this wavy surface 35 results in unexpected advantages. Specifically, it was discovered that the number of needle punctures sllst~ine~l by septum 122 before leakage increased significantly.
For example, in the embodiment illustrated in FIG. l l, insert 130 does not touch septum l 22. In the FIG. l l embodiment, the number of needle punctures before failure was about 1,200 to 1,500 sticks. It was discovered that in the FIG. l 5 embodiment, by colllple;7~ g flanged region 30 of septum l22 by insert l30, septum l22 can sustain up to 3,000 needle sticks before failure.
FIG. l6 illustrates in greater detail 130 co-..~ ing flanged region 30 of septum l22. Also illustrated in FIG. l6 is the portion 35 of housing l20 whic]h is melted by ultrasonic staking solidified into annular ring l29 of insert l30. As explained above, this helps securely contain insert 130 into housing 120.
Septum l22 in the embo-iiment~ of FIGS. l 5 and l6 is preferably injection molded into housing 120 in a non-compressive manner, as explained above. Prior to inserting cup-shaped insert l30, the bottom portion of septum 122 is flat and straight. That is, the wavy, or undulated, surface 35 of septum 122 is not crealed until insert 130 is compressed against flanged region 30. Septum 122 is non-compressively held in housing l20 because it is not compressed across the entire CA 0222~477 1997-12-22 W O 97/01370 PCT~US96/11049 vertical ~1imension of septum 122. The co~ lcs~ion on flanged region 30 by insert 130 is only across the vertical rlimencion of the flanged region 30, and not across the entire vertical (limen~ion of septum 122.
It will be appreciated that the present invention may be used with any 5 combination of plastic and metal. Specifically, the housing may be of plastic or metallic construction. As explained above, dirr.,l~l~t adhesion enh~n~lonnent techniques may be used with metallic and non-metallic housings.
The present invention has significant advantages over the prior art. These advantages included decreased cost of m~nllf~rtllring, increased puncture life and 10 increased resi~t~nce to blowout. Further, because the septum is injection molded, design tolerances of m~nnf~cture may be greater also decreasing expense.
While the foregoing detailed description of the present invention describes the preferred embotliment~, it will be appreciated that it is the intent of the inventors to include all modification and equivalent cleqign~ Accordingly, the scope of the 15 present invention is intended to be limited only by the claims which are appended hereto.
,
Claims (45)
1. A portal for subcutaneous implantation comprising:
a housing having a lumen accessible through a first open end; the lumen including an inner wall, the inner wall having an adhesion promoter thereon adjacent the first open end; and a cured elastomeric septum having an outer periphery bonded to the inner wall adjacent the first open end of the housing.
a housing having a lumen accessible through a first open end; the lumen including an inner wall, the inner wall having an adhesion promoter thereon adjacent the first open end; and a cured elastomeric septum having an outer periphery bonded to the inner wall adjacent the first open end of the housing.
2. The portal of claim 1, wherein the septum includes a bottom surface facing the lumen, the bottom surface being undulated in shape.
3. The portal of claim 1, wherein the septum is injection molded into the lumen of the housing.
4. The portal of claim 3, wherein the inner wall of the housing adjacentthe first open end includes a roughened surface.
5. The portal of claim 3, wherein the inner wall of the housing adjacentthe first open end includes a groove.
6. The portal of claim 1, wherein the septum is silicone and the adhesion promoter includes silane.
7. The portal of claim 1, wherein the housing further includes an outlettube assembly operative in accessing the lumen.
8. The portal of claim 7, wherein the housing further includes a second.open end opposite from the first open end; the second open end including an associated diameter; the portal further comprising a seal operative to close thesecond open end of the housing.
9. The portal of claim 8, wherein the seal comprises a cup-shaped insert.
10. The portal of claim 9, wherein the cup-shaped insert has an associated outer diameter larger than the associated diameter of the second open end of thehousing, the cup-shaped inserted being forced into the second end of the housing to provide an interference fit between the housing and the cup-shaped insert.
11. The portal of claim 9, wherein the cup-shaped insert is ultrasonically staked to the housing.
12. The portal of claim 9, wherein the septum includes a flanged region, and wherein the cup-shaped insert squeezably engages the flanged region.
13. The portal of claim 9, wherein the cup-shaped insert is spaced from the septum at a peripheral edge of the cup-shaped insert.
14. The portal of claim 8, wherein the seal is metallic.
15. The portal of claim 14, wherein the housing is metallic.
16. The portal of claim 7, wherein the housing is non-metallic.
17. The portal of claim 16, wherein the housing is polysulfone.
18. The portal of claim 8, wherein the seal is planar.
19. The portal of claim 18, wherein the seal is a disc.
20. The portal of claim 19, wherein the disc is bonded to the housing adjacent the second end with adhesives.
21. A method of assembling a portal for subcutaneous implantation comprising the steps of:
providing a housing having a first open end; and injection molding a curable elastomeric septum in the first open end of the housing.
providing a housing having a first open end; and injection molding a curable elastomeric septum in the first open end of the housing.
22. The method of claim 21, further comprising the step of applying an adhesion promoter to the housing at the open end prior to injection molding the septum.
23. The method of claim 21, wherein the housing includes a second open end; the method further comprising the step of sealing the second end to form a fluid tight reservoir accessible through the injection molded septum.
24. The method of claim 23, wherein the second open end is sealed with a cup-shaped insert.
25. The method of claim 24 further comprising the step of ultrasonically staking the housing to the cup-shaped insert.
26. The method of claim 24, wherein the second open end of the housing includes an associated diameter and the cup-shaped insert includes an associatedouter diameter larger than the diameter of the second open end, the method further comprising the step of:
forcing the cup-shaped insert into the second open end of the housing to provide an interference fit.
forcing the cup-shaped insert into the second open end of the housing to provide an interference fit.
27. The method of claim 24, wherein the sealing step includes squeezing the septum with the cup-shaped insert.
28. The method of claim 23, wherein the second open end is sealed with a disc.
29. The method of claim 28 further comprising the step of ultrasonically staking the housing adjacent the second open end to the disc.
30. A portal for subcutaneous implantation, the portal comprising:
a housing having a first open end and a second end having a lumen therebetween, the lumen including an inner wall;
an elastomeric septum positioned in the lumen of the housing against the inner wall adjacent the first open end of the housing, the septum having an outer periphery; and a planar member sealing the end of the housing as to define a sealed reservoir accessible through the septum, the planar member spaced from the septum, the planar member and the outer periphery of the septum separated by an air gap.
a housing having a first open end and a second end having a lumen therebetween, the lumen including an inner wall;
an elastomeric septum positioned in the lumen of the housing against the inner wall adjacent the first open end of the housing, the septum having an outer periphery; and a planar member sealing the end of the housing as to define a sealed reservoir accessible through the septum, the planar member spaced from the septum, the planar member and the outer periphery of the septum separated by an air gap.
31. The portal of claim 30, wherein the housing further includes an outlet tube assembly operative in accessing the sealed reservoir.
32. The portal of claim 30, wherein the elastomeric septum is injection molded.
33. The portal of claim 31, wherein the housing is ultrasonically staked to the planar member.
34. The portal of claim 33, wherein the housing further includes an annular lip extending from the housing adjacent the second open end, the lip folded over the planar member as to create a sealed reservoir.
35. The portal of claim 30, wherein the planar member is a disc.
36. A portal for subcutaneous implantation comprising:
a housing having a first open end, a second open end and a lumen therebetween;
a cured elastomeric septum sealing the first open end wherein the septum is injection molded into the first open end; and means for sealing the second open end.
a housing having a first open end, a second open end and a lumen therebetween;
a cured elastomeric septum sealing the first open end wherein the septum is injection molded into the first open end; and means for sealing the second open end.
37. The portal of claim 36, wherein the means for sealing includes a cup-shaped insert.
38. The portal of claim 36, wherein the means for sealing includes a disc.
39. The portal of claim 36, wherein the lumen includes an inner wall, and wherein the septum includes an outer periphery bonded to the inner wall with an adhesion promoter.
40. The portal of claim 36, wherein the means for sealing forcibly engages the septum.
41. The portal of claim 40, wherein the means for sealing includes a cup-shaped insert.
42. The portal of claim 36, wherein the septum has an undulated surface facing the lumen.
43. A portal for subcutaneous implantation comprising:
a silicone septum with first and second opposite surfaces, the second surface being undulated, the septum having a side surface;
an insert engaging the septum, the second surface of the septum facing the insert;
a housing holding the septum and the insert; and an adhesion promoter between the side surface of the septum and the housing, wherein the septum includes a flanged region, and the insert forcibly squeezes the flanged region, and wherein the septum is injection molded into thehousing.
a silicone septum with first and second opposite surfaces, the second surface being undulated, the septum having a side surface;
an insert engaging the septum, the second surface of the septum facing the insert;
a housing holding the septum and the insert; and an adhesion promoter between the side surface of the septum and the housing, wherein the septum includes a flanged region, and the insert forcibly squeezes the flanged region, and wherein the septum is injection molded into thehousing.
44. The portal of claim 43, wherein the insert includes an annular recess, and the housing is ultrasonically staked in to the recess.
45. The portal of claim 43, wherein the housing includes a groove adjacent to the side wall of the septum.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US64495P | 1995-06-29 | 1995-06-29 | |
| US08/670,006 | 1996-06-25 | ||
| US08/670,006 US5989216A (en) | 1995-06-29 | 1996-06-25 | Access portal and method |
| US60/000,644 | 1996-06-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2225477A1 true CA2225477A1 (en) | 1997-01-16 |
Family
ID=26667925
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002225477A Abandoned CA2225477A1 (en) | 1995-06-29 | 1996-06-27 | Access portal and method |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5989216A (en) |
| EP (1) | EP0957973A1 (en) |
| JP (1) | JPH11509110A (en) |
| AU (1) | AU6400596A (en) |
| CA (1) | CA2225477A1 (en) |
| WO (1) | WO1997001370A1 (en) |
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-
1996
- 1996-06-25 US US08/670,006 patent/US5989216A/en not_active Expired - Fee Related
- 1996-06-27 EP EP96923517A patent/EP0957973A1/en not_active Withdrawn
- 1996-06-27 AU AU64005/96A patent/AU6400596A/en not_active Abandoned
- 1996-06-27 JP JP8534379A patent/JPH11509110A/en active Pending
- 1996-06-27 WO PCT/US1996/011049 patent/WO1997001370A1/en not_active Application Discontinuation
- 1996-06-27 CA CA002225477A patent/CA2225477A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO1997001370A1 (en) | 1997-01-16 |
| EP0957973A1 (en) | 1999-11-24 |
| AU6400596A (en) | 1997-01-30 |
| JPH11509110A (en) | 1999-08-17 |
| US5989216A (en) | 1999-11-23 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |