Implantable dual access port with tactile ridge for position sensing

• US 5,360,407 A
• Filed: 08/29/1991
• Issued: 11/01/1994
• 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: Wadsworth, Daniel Jr., Leonard, Arnie
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/753,179
• Time in Patent Office: 1,160 Days
• Field of Search: 604/80, 604/116, 604/175, 604/43, 604/280, 604/93, 604/131-133, 604/140, 604/905, 604/256, 604/244
• 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

The invention comprises an infusion device for infusing fluids to a patient having a plurality of, preferably two, enclosed open cavities, equipped with self-sealing septums. The device comprises a housing having a base, a cap, and a dual-port stem exiting the base and communicating with the open cavities. The cap comprises a tactile raised locating ridge positioned between, and adjacent to, the septums or other self-sealing means so configured that a doctor can simultaneously determine where each septum is located as soon as he locates the single ridge. A doctor can also differentiate between each septum, and determine the location of structures associated with each septum. Furthermore, the ridge is so configured that it does not enclose an area of tissue of the patient, thereby precluding the problem of necrosis.

Claims

1. An implantable device capable of embedment beneath the skin of a patient, the device enabling repeated, non-destructive fluid communication of the distal end of a tubular member, such as a needle or a catheter, piercing the skin of the patient with the proximal end of a selected one of the lumens of a multi-lumen catheter, said device comprising:

a. a 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;

b. first self-sealing means for sealing said first access aperture and for admitting the distal end of the tubular member into said first fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member;

c. second self-sealing means for sealing said second access aperture and for admitting the distal end of the tubular member into said second fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member;

d. means for communicating fluid from each of said first fluid cavity and said second fluid cavity to the patient through a respective one of the lumens of the multi-lumen catheter; and

e. tactile means positioned between the first and the second self-sealing means for simultaneously locating the positions of both of said first and said second self-sealing means by palpating the skin of the patient without thereby impeding access by the distal end of the tubular member to either of said first or said second self-sealing means during palpation of said tactile means, the tactile means comprising a raised locating ridge on the surface of the housing, the locating ridge being configured so as to avoid encircling tissue of the patient that contacts said surface of said housing, and said locating ridge being substantially straight and being so disposed on said surface of said housing as to traverse and be oriented substantially orthogonally to a line connecting the centers of said first and said second self-sealing means.

2. An implantable device as defined in claim 1, wherein said first self-sealing means comprises a first needle-penetrable septum, and said second self-sealing means comprises a second needle-penetrable septum.

3. An implantable device as defined in claim 1, further comprising means for locking the catheter to the implantable device.

4. An implantable device capable of embedment beneath the skin of a patient, the device enabling repeated, non-destructive fluid communication of the distal end of a needle piercing the skin of the patient with the proximal end of a selected one of the lumens of a dual-lumen catheter, said device comprising:

a. a housing enclosing a first fluid cavity and a second fluid cavity, said housing defining in a top surface thereof 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 sealing said first access aperture;

c. a second needle-penetrable septum sealing said second access aperture, the line connecting the center of said first septum and the center of said second septum defining a longitudinal axis of said top surface of said housing;

d. means for communicating fluid from each of said first fluid cavity and said second fluid cavity to a respective one of the lumens of the dual-lumen catheter; and

e. a locating ridge on said top surface of the housing, said locating ridge being raised relative to said top surface of said housing and terminating at each extreme thereof in first and second ends whereat said locating ridge ceases to be raised relative to said top surface of said housing, said locating ridge traversing said longitudinal axis of said top surface between said first septum and said second septum and being disposed with said first and second ends thereof entirely interior of a tactile ridge locating region on said top surface of said housing, said tactile ridge locating region being limited in a direction parallel to said longitudinal axis of said top surface to a region between a first linear boundary and a second linear boundary, said first linear boundary passing through said center of said first septum perpendicular to said longitudinal axis of said top surface, and said second linear boundary passing through said center of said second septum perpendicular to said longitudinal axis of said top surface.

5. An implantable device as defined in claim 4, wherein said means for communicating comprises an outlet stem having a proximal end and a distal end, the proximal end of said outlet stem being attached to the housing and having two separate enclosed stem channels, each of said stem channels communicating with a respective one of said first and said second fluid reservoirs and being longitudinally formed through an individual one of a pair of separately configured prongs, 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 and slidably accept the dual-lumen catheter with each lumen of the catheter communicating with a respective one of the stem channels.

6. An implantable device as defined in claim 5, wherein said means for communicating further comprises a locking sleeve capable of slidably engaging the exterior of the dual-lumen catheter after the catheter has been accepted on said outlet stem, the locking sleeve being so configured as to compress the wall of the catheter against the outer wall of said outlet stem at a position intermediate thereupon, thereby to lock the catheter to said outlet stem.

7. An implantable device as defined in claim 5 further comprising a dual-lumen catheter wherein a web separates the lumens of the dual-lumen catheter, and the web is received into said slot between said prongs of said outlet stem when the catheter is accepted on said outlet stem.

8. An implantable device as defined in claim 5, wherein the locating ridge comprises indicator means determine the location of the outlet stem in relation to the first and second septums.

9. An implantable device as defined in claim 8, wherein the indicator means comprises an arrow-shaped appendage.

10. An implantable device as defined in claim 4, wherein the locating ridge is substantially straight.

11. An implantable device as defined in claim 10, wherein the locating ridge is is oriented substantially orthogonally to said longitudinal axis of said top surface of said housing.

12. An implantable device as recited in claim 11, wherein said locating ridge is enlarged at one end thereof.

13. An implantable device as defined in claim 4, wherein the housing comprises a cap and base in fixed engagement with each other.

14. An implantable device as defined in claim 13, wherein the housing is comprised of plastic.

15. An implantable device as defined in claim 13, wherein the cap comprises an upper wall having a top surface and an encircling skirt depending from the periphery of said upper wall.

16. An implantable device as defined in claim 15, wherein the locating ridge is integrally formed on the top surface of the cap of said housing.

17. An implantable device as defined in claim 15, wherein the encircling skirt is configured with an opening therethrough sized and shaped so as to permit the passage therethrough of said means for communicating when the cap and the base are fixedly engaged with each other.

18. An implantable device as defined in claim 13, wherein the base comprises a floor having a flat bottom surface, and on the side of said floor opposite from said bottom surface said base is formed into two recesses configured so as to comprise respectively said first and second cavities.

19. An implantable device as defined in claim 4, wherein the locating ridge is substantially straight and is oriented substantially parallel to a line connecting the centers of the first and second self-sealing means.

20. An implantable device as defined in claim 4, wherein the locating ridge comprises an elongate shape, each end of said elongate shape being enlarged with respect to a portion intermediate the ends thereof.

21. An implantable device as defined in claim 4, wherein the locating ridge is substantially "S"-shaped.

22. An implantable device as defined in claim 4, wherein the locating ridge is substantially "X"-shaped.

23. An implantable device as defined in claim 4, wherein the locating ridge comprises:

a. a circular segment; and

b. a short straight line segment oriented substantially parallel to a line connecting the centers of the first and second septums.

24. An implantable device as defined in claim 4, wherein the locating ridge comprises indicator means to differentiate between said first and second septums.

25. An implantable device capable of embedment beneath the skin of a patient, the device enabling repeated nondestructive fluid communication by the distal end of a needle piercing the skin of the patient with a selected one of a first fluid cavity or a second fluid cavity formed in the device, said device comprising:

a. a housing enclosing the first fluid cavity and the 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;

b. a first needle-penetrable septum sealing said first access aperture;

c. a second needle-penetrable septum sealing said second access aperture; and

d. a raised locating ridge integrally formed on the surface of said housing between said first septum and said second septum, said locating ridge being configured so as to avoid encircling tissue of the patient contacting the surface of said housing when said device is embedded beneath the skin of the patient, said locating ridge being substantially straight and being so disposed on said surface of said housing as to traverse and be oriented substantially orthogonally to a line connecting the center of said first septum and the center of said second septum.

26. An implantable device as recited in claim 25, further comprising an outlet stem having a proximal end and a distal end, said proximal end of said outlet stem being attached to said housing and having two separate enclosed stem channels,each of said stem channels communicating with a respecting one of said first and said second fluid reservoirs and being longitudinally formed through an individual one of a pair of separately configured prongs, said prongs being spaced apart from each by an elongate slot extending from the distal end of said outlet stem to a point intermediate the length of said outlet stem, said proximal end of said outlet stem being configured so as to snugly and slidingly accept the dual-lumen catheter with each lumen of the catheter communicating with a respective stem passageway of said outlet stem, and with a web of the catheter that separates the lumens thereof being received into said slot between said prongs of said outlet stem.

27. An implantable device capable of embedment beneath the skin of a patient, the device enabling repeated, non-destructive fluid communication by the distal end of a tubular member, such as a needle or a catheter, piercing the skin of the patient with a selected one of a first fluid cavity or a second fluid cavity formed in the device, said device comprising:

a. a housing enclosing the first fluid cavity and the second fluid cavity, said housing defining a first access aperture communicating through said housing with the first fluid cavity and a second access aperture communicating through said housing with the second fluid cavity;

b. first self-sealing means for sealing said first access aperture and for admitting the distal end of the tubular member into the first fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member;

c. second self-sealing means for sealing said second access aperture and for admitting the distal end of the tubular member into the second fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member;

d. a substantially straight tactile locating ridge upstanding on the surface of said housing between said first self-sealing means and said second self-sealing means, said locating ridge being so disposed on said surface of said housing as to traverse and be oriented substantially orthogonally to a line connecting the center of said first self-sealing means and the center of said second self-sealing means.

28. An implantable device as recited in claim 27, wherein said locating ridge is enlarged at one end thereof.

29. An implantable device capable of embedment beneath the skin of a patient, the device enabling repeated, non-destructive fluid communication of the distal end of a tubular member, such as a needle or a catheter, piercing the skin of the patient with the proximal end of a selected one of the lumens of a multi-lumen catheter, said device comprising:

a. a housing enclosing a first fluid cavity and a second fluid cavity, said housing defining in a top surface thereof 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. first self-sealing means for sealing said first access aperture and for admitting the distal end of the tubular member into said first fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member;

c. second self-sealing means for sealing said second access aperture and for admitting the distal end of the tubular member into said second fluid cavity, thereby to enable the infusion of fluids thereinto through the tubular member, the line connecting the center of said first self-sealing means and the center of said second self-sealing means defining a longitudinal axis of said top surface of said housing;

d. means for communicating fluid from each of said first fluid cavity and said second fluid cavity to the patient through a respective one of the lumens of the multi-lumen catheter; and

e. a locating ridge on said top surface of the housing, said locating ridge being raised relative to said top surface of said housing and terminating at each extreme thereof in first and second ends whereat said locating ridge ceases to be raised relative to said top surface of said housing, said locating ridge traversing said longitudinal axis thereof between said first self-sealing means and said second self-sealing means and being with said first and second ends thereof disposed entirely interior of a tactile ridge locating region on said top surface of said housing, said tactile ridge locating region being limited in a direction parallel to said longitudinal axis of said top surface to a region between a first linear boundary and a second linear boundary, said first linear boundary passing through said center of said first self-sealing means perpendicular to said longitudinal axis of said top surface, and said second linear boundary passing through said center of said second self-sealing means perpendicular to said longitudinal axis of said top surface.

30. An implantable device as recited in claim 29, wherein said tactile locating ridge is substantially straight and is oriented substantially orthogonally to said longitudinal axis of said top surface of said housing.

31. An implantable device as defined in claim 29, wherein the locating ridge is substantially straight and is oriented substantially parallel to a line connecting the centers of the first and second self-sealing means.

32. An implantable device as defined in claim 29, wherein the locating ridge comprises an elongate shape, each end of said elongate shape being enlarged with respect to a portion intermediate the ends thereof.

33. An implantable device as defined in claim 29, wherein the locating ridge is substantially "S" shaped.

34. An implantable device as defined in claim 29, wherein the locating ridge is substantially "X"-shaped.

35. An implantable device as defined in claim 29, wherein the locating ridge comprises:

a. a circular segment; and

b. a short straight line segment oriented substantially parallel to a line connecting the first and second centers of the self-sealing means.

36. An implantable device as defined in claim 29, wherein the tactile means comprises indicator means to differentiate between said first and said second self-sealing means.

37. An implantable device as defined in claim 29, wherein the tactile means comprises indicator means to determine the location of said means for communicating fluid in relation to the first and the second self-sealing means.

38. An implantable device as defined in claim 37, wherein the indicator means comprises an arrow-shaped appendage.