Implantable plural fluid cavity port

• US 5,399,168 A
• Filed: 07/29/1992
• Issued: 03/21/1995
• Est. Priority Date: 08/29/1991
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Bassett, Patricia A., Wadsworth, Daniel C. Jr., Felix, Augustus, Nevers, Craig S., Christian, Kelly J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/922,534
• Time in Patent Office: 965 Days
• Field of Search: 604/93, 604/173-175, 604/244, 604/283, 604/80, 285/242
• US Class Current: 604/175
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A subcutaneous implantable access port is formed of a housing having a pair of noncircular fluid cavities enclosed therein by a floor, walls upstanding from the floor, and a self-sealing septum positioned above each fluid cavity. The housing is constructed of a base, a septum support, and a cap. An outlet stem exits the base and communicates with the fluid cavities therein. The outlet stem has two prongs formed in a side-by-side configuration extending outwardly from the base. The prongs are formed within the stem channels in fluid communication with the fluid cavities. Protruding radially outwardly from the portion of said prong is a barb. Fluid injected into the fluid cavity through the septum flows through a smooth transition region in which the cross-sectional area is smoothly reduced from the corresponding fluid cavity. A locking sleeve provides radial inward pressure upon the catheter which is slid over the outlet stem, thereby insuring that the catheter remains mounted on the outlet stem.

Claims

1. An implantable access port capable of being implanted beneath the skin of a patient, the access port enabling repeated, non-destructive fluid communication between the tip of a hypodermic needle piercing the skin of the patient and the proximal end of a selected one of the lumens of a dual lumen catheter implanted in the body of the patient coupled to the access port, thereby to selectively inject a fluid from the needle into the body of the patient by producing a flow of the fluid from the tip of the needle, through the access port, and along the selected one of the lumens to the distal end of the catheter, said access port comprising:

(a) a needle-impenetrable housing enclosing a first fluid cavity and a second fluid cavity, said housing defining a first access aperture communicating through said housing with said first fluid cavity and a second access aperture communicating through said housing with said second fluid cavity, said housing comprising;

(i) a needle-impenetrable base having a flat interior floor and walls normal to and upstanding therefrom, said walls defining said first fluid cavity and said second fluid cavity, said first fluid cavity having a cross-section in a plane parallel to said floor of said base that is noncircular;

(ii) a septum support configured to mate with the ends of said walls of said base opposite from said floor of said base, said septum support having formed therethrough a first septum receiving aperture positioned above said first fluid cavity and a second septum receiving aperture positioned above said second fluid cavity;

(iii) a needle-impenetrable cap configured to receive said septum support and said base, said cap comprising a top wall having formed therein;

(A) a first septum access aperture communicating through said top wall of said cap at a position opposite said first septum receiving aperture when said septum support and said base are received in said cap, said first septum access aperture and said first septum receiving aperture together defining said first access aperture; and

(B) a second septum access aperture communicating through said top wall at a position opposite said second septum receiving aperture when said septum support and said base are received in said cap, said second septum access aperture and said second septum receiving aperture together defining said second access aperture;

(b) a first needle-penetrable septum captured by said housing and sealing said first access aperture;

(c) a second needle-penetrable septum captured by said housing and sealing said second access aperture;

(d) an outlet stem connected at a proximal end thereof with said housing and configured at a distal end thereof to receive the proximal end of the catheter, said stem enclosing a first stem channel and a second stem channel, said first and second stem channels extending in side-by-side relationship between said distal and said proximal ends of said stem, the proximal ends of said first and Second stem channels being separated laterally a distance substantially equal to the lateral separation of the lumens in the catheter;

(e) a first exit passageway formed in said housing communicating with said proximal end of said first stem channel; and

(f) first interface means for placing said first fluid cavity in fluid flow communication with said first exit passageway and for causing the flow of the fluid through said access port from said first fluid cavity into said first exit passageway to be substantially free of turbulence, said first interface means comprising a first transition region formed between said first fluid cavity and said first exit passageway having a lateral cross-section smoothly reducing in area along said first transition region from said first fluid cavity to said first exit passageway.

2. An access port as recited in claim 1, further comprising:

(a) a second exit passageway formed in said housing communicating with said proximal end of said second stem channel; and

(b) second interface means for placing said second fluid cavity in fluid flow communication with said second exit passageway and for causing the flow of the fluid through said access port from said second fluid cavity into said second exit passageway to be substantially free of turbulence, said second interface means comprising a second transition region formed between said second fluid cavity and said second exit passageway having a lateral cross-section smoothly reducing in area along said second transition region from said second fluid cavity to said second exit passageway.

3. An access port as recited in claim 2, wherein said transition region has walls free of sharp turns.

4. An access port as recited in claim 2, wherein said transition region has walls free of sharp edges.

5. An access port as recited in claim 2, wherein said first interface means and said second interface means are located within said housing on adjacent sides of said first fluid cavity and said second fluid cavity, respectively.

6. An access port as recited in claim 1, wherein the longitudinal axis of said outlet stem is disposed in a plane normal to and bisecting of a line connecting the center of said first fluid cavity with the center of said second fluid cavity.

7. An access port as recited in claim 1, wherein said first and said second stem channels are linear.

8. An access port as recited in claim 1, wherein said first and said second stem channels are disposed in parallel relationship to each other.

9. An access port as recited in claim 1, wherein said first and said second stem channels are elliptical in cross-section.

10. An access port as recited in claim 1, wherein said housing further comprises:

(a) an interior top wall disposed opposite said interior floor of said housing and being generally parallel thereto;

(b) side walls extending from the periphery of said floor to said top wall; and

(c) a dividing wall extending between said floor, said top wall, and opposed portions of said side walls, thereby to define on opposite sides of said dividing wall said first fluid cavity and said second fluid cavity, respectively.

11. An access port as recited in claim 10, wherein said first access aperture and said second access aperture are formed through said top wall of said housing, and wherein the cross-section of said first and second access apertures are circular.

12. An access port as recited in claim 10, wherein the cross-section of the Combination of said first fluid cavity said first transition region taken in a plane parallel to said floor of said housing is noncircular.

13. An access port as recited in claim 12, wherein said cross-section of said combination of said first fluid cavity and said first transition region taken in a plan parallel to said floor of said housing comprises in combination:

(a) a circle; and

(b) an appendage having a vertex and first and second sides adjacent thereto, said vertex of said appendage being directed away from said circle with said first and second sides of said appendage joining said circle at the circumference thereof.

14. An access port as recited in claim 1, wherein said outlet stem comprises a proximal end and a distal end, the proximal end of said outlet stem being attached to said housing and enclosing two separate enclosed stem channels, each of said stem channels communicating with a respective one of said fluid cavities and being longitudinally formed through a separately configured prong, said prongs being spaced apart from each other by an elongate slot extending from the distal end of said outlet stem to a point intermediate the length of said outlet stem, the proximal end of said outlet stem being configured so as to snugly accept the catheter, with each lumen of the catheter communicating with a respective stem channel, and with the web of the catheter that separates the lumens thereof being received into the elongate slot between said prongs of said stem.

15. An access port as recited in claim 14, wherein said walls upstanding from said interior floor of said base further comprise a dividing wall separating said first fluid cavity from said second fluid cavity, said dividing wall having a thickness substantially equal to the lateral separation of the lumens of the catheter.

16. An access port as recited in claim 14, wherein each of said first and said second prongs comprise a barb protruding radially outwardly from an outer surface thereof.

17. An access port as recited in claim 1, wherein said base, said septum support, and said cap are provided with suitable voids and flash channels so as to enable ultrasonic bonding of said septum support to said base and of said septum support and said base inside said cap.

18. An access port as recited in claim 1, wherein said outlet stem is secured to said base.

19. An access port as recited in claim 14, wherein the cross-section of each prong corresponds to the internal cross-section of a corresponding lumen of the catheter.

20. An access port as recited in claim 1, wherein said outlet stem is formed integrally with said base.

21. An access port as recited in claim 1, wherein said base further comprises an attachment flange formed at the periphery thereof and disposed in a substantially co-planar relationship with said floor thereof.

22. An access port as recited in claim 21, wherein suture apertures are formed through said attachment flange.

23. An access port as recited in claim 1, further comprising:

(a) a first needle-penetrable septum captured between said septum support and said cap sealing said first access aperture; and

(b) a second needle-penetrable septum captured between said septum support and said cap sealing said second access aperture.

24. An access port as recited in claim 23, wherein said base, said septum support, and said cap are ultrasonically bonded to form a needle-impenetrable housing.

25. An access port as recited in claim 23, wherein said cap further comprises a skirt depending from the periphery of said top wall of said cap, said skirt enclosing said septum support and said walls of said base when said septum support and said base are received in said cap.

26. An access port as recited in claim 25, further comprising an outlet stem connected at a proximal end thereof with said housing and configured at a distal end thereof to receive the proximal end of the catheter.

27. An access port as recited in claim 26, wherein said outlet stem is integrally formed with said base.

28. An access port as recited in claim 26, wherein said outlet stem projects through said skirt of said cap generally parallel to said floor of said base when said base is received in said cap.

29. An access port as recited in claim 1, wherein the cross-section of said first fluid cavity and the cross-section of said second fluid cavity taken in a plane parallel to said floor of said base differ in shape from the cross-section of said first septum receiving aperture and the cross-section of said second septum receiving aperture, respectively.

30. An access port as recited in claim 29, wherein said cross-section of said first septum receiving aperture and said cross-section of said second septum receiving aperture are circular.

31. An access port as recited in claim 29, wherein said cross-section of said first fluid cavity and said cross-section of said second fluid cavity are noncircular.

32. An implantable access port capable of being implanted beneath the skin of a patient, the access port enabling repeated, non-destructive fluid communication between the tip of a hypodermic needle piercing the skin of the patient and the proximal end of a selected one of the lumens of a dual lumen catheter, implanted in the body of the patient coupled to the access port, thereby to selectively inject a fluid from the needle into the body of the patient by producing a flow of the fluid from the tip of the needle, through the access port, and along the selected one of the lumens to the distal end of the catheter, said access port comprising:

(a) a needle impenetrable housing enclosing a first fluid cavity and a second fluid cavity, said housing having a generally planar interior floor and defining a first access aperture communicating through said housing with said first fluid cavity and a second access aperture communicating through said housing with said second fluid cavity;

(b) a first needle-penetrable septum captured by said housing and sealing said first access aperture;

(c) a second needle-penetrable septum captured by said housing and sealing said second access aperture;

(d) first and second exit passageways formed through said housing in side-by-side relationship separated laterally a distance substantially equal to the lateral separation of the lumens in the catheter; and

(e) outlet means for placing said first fluid cavity and said second fluid cavity in fluid flow communication, respectively, with said first exit passageway and said second exit passageway and for causing the flow of fluid through said access port from said first fluid cavity and said second fluid cavity, respectively into said first exit passageway and said second exit passageway to be substantially free of turbulence, said outlet means comprising;

(i) a first transition region formed interior of said housing between said first fluid cavity and said first exit passageway, said first transition region having a top surface disposed parallel to said interior floor of said housing and therebetween side surfaces tapering smoothly from said first fluid cavity to said first exit passageway, in a lateral cross-section taken parallel to said interior floor of said housing a first of said side surfaces appearing linear and a second of said side surfaces appearing S-shaped; and

(ii) a second transition region formed interior of said housing between said second fluid cavity and said second exit passageway, said second transition region having a top surface disposed parallel to said interior floor of said housing and therebetween side surfaces tapering smoothly from said second fluid cavity to said second exit passageway, in a lateral cross-section taken parallel to said interior floor of said housing a first of said side surfaces appearing linear and a second of said side surfaces appearing S-shaped.

33. An access port as recited in claim 32, wherein said side surfaces of said first and second transition regions are free of sharp turns.

34. An access port as recited in claim 32, wherein said side surfaces of said first and second transition regions are free of sharp edges.

35. An implantable access port system capable of being implanted beneath the skin of a patient, said system comprising:

(a) an access port having a housing with two fluid cavities formed therein;

(b) an outlet stem protruding from said housing and having barbs protruding radially outwardly from an outer surface thereof;

(c) a dual-lumen catheter capable of being attached at the proximal end thereof to said outlet stem by the advancement of said catheter over said barbs of said outlet stem; and

(d) a locking sleeve capable of being slid over said proximal end of said catheter into a locking position of said locking sleeve, when said proximal end of said catheter has been advanced over said outer surface of said outlet stem, said locking sleeve in said locking position thereof exerting radial compression on said proximal end of said catheter and on said outlet stem, thereby to resist the removal of said catheter from said outlet stem, said locking sleeve comprising a locking surface protruding inwardly from an inner surface of said locking sleeve, said locking surface tapering gradually inwardly from the distal end of said locking sleeve to a narrowest point of said inner surface of said locking sleeve located intermediate said distal end and the proximal end thereof, said narrowest point being disposed between said housing and said barb on said outlet stem when said locking sleeve is in said locking position thereof.

36. An implantable access port system as recited in claim 35, wherein said outlet stem is connected at a proximal end thereof with said housing and is configured at the distal end thereof to receive the proximal end of said catheter, said outlet stem comprising:

(a) a plurality of prongs connected at a proximal end of each thereof to said housing, one of said prongs corresponding to each of said fluid cavities, said prongs projecting in a spaced-apart substantially parallel array from said housing with the distal ends of said prongs positioned to be receivable individually in a corresponding one of each of the lumens of said catheter, each of said prongs having a ramped surface on the exterior thereof intermediate said proximal and said distal ends of each of said prongs; and

(b) a plurality of exit passageways, one of said exit passageways corresponding to and communicating with an individual one of each of said fluid cavities, each of said exit passageways communicating with a stem channel extending within an individual one of said prongs from said distal to said proximal ends thereof.

37. An implantable access system as recited in claim 36, wherein said locking surface and said narrowest point of said inner surface of said locking sleeve comprise safety means for biasing said locking sleeve into said. locking position thereof.

38. An implantable access port system as recited in claim 37, wherein said safety means further comprises a safety ramp protruding inwardly from an inner surface of said locking sleeve at a point corresponding to said ramped surface on said exterior of said prongs of said outlet stem in said locking position of said locking sleeve, thereby to tightly engage said catheter between said safety ramp of said locking sleeve and said ramped surface of each of said prongs, when said locking sleeve is in said locking position thereof.

39. An access port system as recited in claim 36, wherein a web separates the lumens of the catheter, and said locking sleeve is so configured as to compress the wall of the catheter against the outer surface of said outlet stem at a position intermediate said distal and proximal ends of said prongs, thereby to urge said prongs of said outlet stem toward each other and into engagement with the web of the catheter.