Venous access port with molded and/or radiopaque indicia

Abstract

A venous access port assembly having a base, a peripheral surface, and a septum. The base defines an interior reservoir. The peripheral surface includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the peripheral surface from a top surface to a bottom surface thereof. According to one aspect, the peripheral surface may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material, or they may be formed by voids in the X-ray discernable material. According to another aspect, the peripheral surface may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the peripheral surface applied with the radiopaque agent.

Claims

1. A venous access port assembly for implantation into a patient, comprising: a housing comprising: a base defining at least one reservoir; and a peripheral surface adjacent to the at least one reservoir and extends outwardly from the base about a perimeter of the at least one reservoir, the peripheral surface comprising X-ray discernable indicia configured to indicate, under X-ray examination, that the assembly is rated for power injection, wherein the peripheral surface is comprised of X-ray discernable material, and wherein the peripheral surface further comprises a top surface, a bottom surface, and one or more voids extending through a height of the peripheral surface from the top surface of the peripheral surface to the bottom surface of the peripheral surface; and a needle-penetrable septum communicating with the housing; wherein the base has a bottom outer surface including at least one of the X-ray discernable indicia within a region directly beneath the at least one reservoir, wherein the X-ray discernable indicia are the one or more voids in the peripheral surface and are comprised of the X-ray discernable material.

2. The assembly of claim 1, wherein the housing further comprises a skirt overmolded about at least a portion of the base.

3. The assembly of claim 2, wherein the skirt is further overmolded about the peripheral surface.

4. The assembly of claim 2, wherein the skirt comprises a radiotransparent or radiolucent material.

5. The assembly of claim 1, wherein the X-ray discernable indicia further indicate, under X-ray examination, that the assembly is adapted to withstand high pressures used for injection of contrast fluid.

6. The assembly of claim 1, wherein the X-ray discernable indicia extend through a height of the peripheral surface from a top surface of the peripheral surface to a bottom surface of the peripheral surface.

7. A venous access port assembly for implantation into a patient, comprising: a housing comprising: a housing base defining at least one reservoir; and a peripheral surface adjacent to the at least one reservoir and extends outwardly from the housing base about a perimeter of the at least one reservoir, the peripheral surface comprising X-ray discernable indicia configured to indicate, under X-ray examination, that the assembly is rated for power injection, wherein the peripheral surface is comprised of X-ray discernable material, and wherein the peripheral surface further comprises a top surface, a bottom surface, and one or more voids extending through a height of the peripheral surface from the top surface of the peripheral surface to the bottom surface of the peripheral surface; and a needle-penetrable septum secured to the housing; wherein the housing base has a bottom outer surface including at least one of the X-ray discernable indicia within a region directly beneath the at least one reservoir, and wherein the X-ray discernable indicia are the one or more voids in the peripheral surface and are comprised of the X-ray discernable material.

8. The venous access port assembly of claim 7, wherein the housing further comprises a radiotransparent or radiolucent skirt overmolded about at least a portion of the housing base.

9. The venous access port assembly of claim 8, wherein the radiotransparent or radiolucent skirt is further overmolded about the peripheral surface.

10. The venous access port assembly of claim 7, wherein the X-ray discernable indicia further indicate, under X-ray examination, that the assembly is adapted to withstand high pressures used for injection of contrast fluid.

11. A venous access port assembly for implantation into a patient, comprising: a housing comprising: a housing base comprising a well comprising a bottom floor and side walls, the bottom floor and side walls defining at least one reservoir; and a peripheral surface adjacent to the at least one reservoir and extends outwardly from the housing base about a perimeter of the at least one reservoir, the peripheral surface comprising X-ray discernable indicia configured to indicate, under X-ray examination, that the assembly is rated for power injection, wherein the peripheral surface is comprised of X-ray discernable material, and wherein the peripheral surface further comprises a top surface, a bottom surface, and one or more voids extending through a height of the peripheral surface from the top surface of the peripheral surface to the bottom surface of a peripheral surface; a needle-penetrable septum; and a cap securing the needle-penetrable septum to the housing; wherein the housing base has a bottom outer surface including at least one of the X-ray discernable indicia within a region directly beneath the at least one reservoir, and wherein the X-ray discernable indicia are the one or more voids in the peripheral surface and are comprised of the X-ray discernable material.

12. The venous access port assembly of claim 11, wherein the housing further comprises a radiotransparent or radiolucent skirt overmolded about at least a portion of the housing base.

13. The venous access port assembly of claim 12, wherein the radiotransparent or radiolucent skirt is further overmolded about the peripheral surface.

14. The venous access port assembly of claim 11, wherein the X-ray discernable indicia further indicate, under X-ray examination, that the assembly is adapted to withstand high pressures used for injection of contrast fluid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:

(2) FIG. 1 is an isometric view of one embodiment of a venous access port of the present invention;

(3) FIG. 2 is a plan view of the port of FIG. 1;

(4) FIGS. 3 and 4 are cross-sectional views of the port of FIGS. 1 and 2 taken along lines 3-3 and lines 4-4 of FIG. 2, respectively;

(5) FIG. 5 is an isometric view of a needle-impenetrable housing base of the venous access port of FIG. 1;

(6) FIGS. 6 and 7 are transverse cross-sectional and longitudinal cross-sectional views of the housing base of FIG. 5;

(7) FIG. 8 is an isometric view from below of one embodiment of the housing base of FIG. 5, showing radiopaque indicia applied on the housing base bottom surface;

(8) FIGS. 9 and 10 are bottom and top views of the housing base of FIG. 8 having radiopaque indicia thereon, with the top view (FIG. 10) being analogous to a X-ray view of the venous access port seen by a radiologist, with indicia visible by X-ray shown by dashed lines in FIG. 10;

(9) FIG. 11 illustrates top views of two alternative embodiments of the needle-impenetrable housing base of the venous access port of FIG. 1, showing integrally molded CT markings;

(10) FIG. 12 illustrates an isometric view of one of the FIG. 11 embodiments of the needle-impenetrable housing base of the venous access port of FIG. 1, featuring an integrally molded CT marking where the letters CT are formed of housing material; and

(11) FIG. 13 illustrates an isometric view of the other of the FIG. 11 embodiments of the needle-impenetrable housing base of the venous access port of FIG. 1, featuring an integrally molded CT marking where the letters CT comprise voids in the housing material, as if cut or punched out of the housing material.

DETAILED DESCRIPTION OF THE INVENTION

(12) Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms distal and proximal refer, respectively, to directions closer to and away from the insertion tip of a catheter in an implantable catheter assembly. The terminology includes the words specifically mentioned, derivatives thereof, and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.

(13) Venous access port assembly 10 of FIGS. 1 to 4 includes a housing 12 and a septum 14, with a discharge port 16 extending from a distal end 18 of the port assembly 10 to be attached securely and sealingly to the proximal end of a catheter (not shown). A passageway 20 extends from the interior reservoir 22 to the distal tip opening 24 of discharge port 16. A recess 26 is seen to be provided along both sides of discharge port 16, facilitating insertion of the discharge port 16 into the catheter lumen and providing a clearance for a locking sleeve or clamp (not shown) utilized to compress the catheter lumen wall against the exterior surface of the discharge port 16 for assured sealed connection of the catheter with the port assembly 10.

(14) With reference now to FIGS. 3 to 7, the interior of the port assembly 10 is shown to provide an interior reservoir 22. Housing 12 is shown to include a housing base 28 of needle-impenetrable material that includes a well 30 having a bottom floor 32 and side walls 34 that define the interior reservoir 22 beneath septum 14. Bottom floor 32 may be convex or elevated (not shown) toward the center of the reservoir, if desired. Housing base 28 includes a base flange 36 extending radially outwardly from the bottom of well 30, and base flange 36 includes openings 38, 40 that serve to enable suturing to the patient upon placement of the venous access port and the attached catheter into the patient.

(15) As shown in FIGS. 3 and 4, a skirt 42 is overmolded about housing base 28 and may be of silicone elastomer. It is seen that skirt 42 encapsulates the outer surfaces of the bottom wall 44 and the bottom portion of the side walls 46 of housing base 28, and is shown to fill in the suture holes 38, 40; but since the material is silicone elastomer, suturing is possible since the suturing needle can easily be inserted through the material of skirt 42 and through the suture holes, and thereafter the filled openings provide minimal opportunity for ingrowth of patient tissue into the openings.

(16) Also seen in FIGS. 1 to 4 is cap 48, which secures to housing base 28 to in turn secure septum 14 in position in the port assembly 10. Preferably, skirt 42 is insert molded onto base flange 36 of housing base 28 after cap 48 is secured to the upper portion of housing base 28 to secure the septum in position. It is seen in FIGS. 4 and 7 that discharge port 16 is integral with housing base 28 as is preferable. Discharge port 16 is shown to have a pair of annular ridges 50 that facilitate with the mechanical connection of the catheter proximal end with the port assembly 10. Housing base 28 includes a septum seat 52 extending into the top of well 30, into which a flange of the septum will be seated, preferably under radially inward compression. Housing base 28 has a bottom outer surface 54.

(17) Radiopaque markings 60 of the present invention are shown in FIGS. 8 to 10. A larger outer circle 62 is seen provided on the outermost periphery of bottom base surface 54, and a smaller inner circle 64 is seen provided within the area circumscribed by the suture openings 38 and holes 40 through base flange 36. Adjacent to discharge port 16, a recess 56 is provided in the skirt of the housing base to provide a clearance for use of a connection sleeve that will be used to secure the catheter (not shown), and outer circle 62 is shown to have a gap 66 at the recess. Outer and inner circles or rings 62, 64 circumscribe radiopaque indicia 70.

(18) Radiopaque indicia 70 are provided on bottom outer surface 54 within the region directly beneath the reservoir and septum. In the example shown, indicia 70 comprise the letters CT (FIG. 10) representing the term computed tomography. The meaning of this particular example of indicia is that the venous access port assembly 10 is rated for high pressure injection such as is necessary for infusion into the patient of contrast medium that is used in computed tomography. Other indicia may of course be used that indicate some other attribute or characteristic of the venous access port assembly. The radiopaque markings and indicia would appear on an X-ray of the patient, and the indicia are provided in a mirror-image orientation on the bottom outer surface of the housing base (FIGS. 7 and 8) so that the indicia would appear as CT when the X-ray is viewed (FIG. 9), easily discerned by the radiologist or technologist. Centering of the indicia within the region (identified as 30, 22 in FIG. 10) directly beneath the reservoir and septum minimizes any obscuring by the structure of the venous access port assembly, and the indicia may also be easily discernable should the port assembly be at an angle from the horizontal plane of the X-ray; the outer and inner circles 62, 64 would appear oval or elliptical should the port assembly be at such an angle. Gap 66 in outer circle 62 would also appear and would indicate the location of the discharge port stem 16.

(19) The radiopaque markings may constitute marking fluid that is embossed or imprinted or otherwise applied onto the surface of the housing base 28, such as black radiopaque ink Part No. C11002 Rev A formulated by CI Medical, Inc., 15 Commerce Way, Norton, Mass. 02766, from Marabu Tampapur TPU 910 clear with tungsten added, available from Marabuwerke GmbH & Co. KG of Stuttgart, Germany, and may be applied on plasma-treated surfaces. At least the housing base 28, the septum 14 and the skirt 42 are of radiotransparent or radiolucent material as is well known in implanted medical devices, and the housing base may be molded of polysulfone resin.

(20) The radiopaque markings may alternatively applied to the inwardly facing surface of the bottom wall of the housing base, or may constitute foil or film (such as a decal) of radiopaque material embedded within the housing base, these alternatives not being shown in the drawings.

(21) FIG. 11 illustrates top views of two alternative embodiments 72, 74 of the needle-impenetrable housing base 28 of the venous access port 10 of the present invention. Each of the alternative embodiments 72, 74 shows CT markings integrally formed in the base flange 36 of the housing base 28. The first alternative embodiment 72, an isometric view of which is illustrated in FIG. 12, features integrally molded CT markings within the suture openings 38, where the letters CT are formed of the base flange 36 material. The second alternative embodiment 74, an isometric view of which is illustrated in FIG. 13, features integrally molded CT markings alongside the suture openings 38, 40, where the markings are voids in the base flange 36 material, as if cut or punched out of the base flange 36 material. Naturally, the markings could be configured elsewhere within or about the housing base 28, or within a peripheral portion of another component of the venous access port 10.

(22) If the housing base 28 is made of a plastic material, such as a silicone elastomer or polysulfone resin, the letters CT, or the base flange 36, or the entire housing base 28, could be applied with a radiopaque agent or fluid, allowing the applied area to be visible by X-ray examination. If the housing base 28 is comprised of a metal material, or if the base flange 36, or a portion thereof, is comprised of metal (particularly the letters CT), those portions would naturally be visible by X-ray examination without application of the radiopaque agent.

(23) It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.