RADIOPAQUE AND SEPTUM-BASED INDICATORS FOR A MULTI-LUMEN IMPLANTABLE PORT

• US 20090156928A1
• Filed: 11/07/2008
• Published: 06/18/2009
• Est. Priority Date: 11/07/2007
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Vader, Mark Henry, Evans, John G., Christian, Kelly J., Cise, David M., Amin, Murtaza
• Granted Patent: US 9,579,496 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2205/0211 Ceramics
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

An implantable multi-lumen access port including indicators for ascertaining characteristics of the port is disclosed. In one embodiment, the access port comprises a housing that defines a first reservoir and a second reservoir. A first septum and second septum are respectively coupled with the housing to provide selective access to the first and second reservoirs. Each septum includes a plurality of protrusions defined about a periphery thereof that are palpable after implantation of the port in a patient to determine a relative position of the first septum with respect to the second septum. A radiographically observable indicator is also included on a base of the housing, so as to provide information relating to a characteristic of the dual-lumen port, such as suitability for power injection of fluids. The indicator in one embodiment includes a substantially rigid radiopaque component.

Claims

1. An implantable multi-lumen port, comprising:

a housing defining at least a first fluid reservoir and a second fluid reservoir;

a needle-penetrable first septum that provides selective access to the first fluid reservoir;

a needle-penetrable second septum that provides selective access to the second fluid reservoir; and

a set of palpation features, including;

a first plurality of protrusions included proximate a periphery of the first septum; and

a second plurality of protrusions included proximate a periphery of the second septum, the first and second plurality of protrusions being palpable when the port is implanted in a patient so as to determine a characteristic of one of the first septum and the second septum with respect to the other septum.

2. The multi-lumen port as defined in claim 1, wherein the protrusions of the first plurality are defined by the housing about the first septum, and wherein the protrusions of the second plurality are defined by the housing about the second septum.

3. The multi-lumen port as defined in claim 1, wherein the protrusions of the first plurality are defined by the first septum about the periphery of the first septum, and wherein the protrusions of the second plurality are defined by the second septum about the periphery of the second septum.

4. The multi-lumen port as defined in claim 3, wherein the number of protrusions of the first plurality equals the number of protrusions of the second plurality.

5. The multi-lumen port as defined in claim 4, wherein the first plurality includes three protrusions defined by the first septum, and wherein the second plurality includes three protrusions defined by the second septum.

6. The multi-lumen port as defined in claim 5, wherein the three protrusions of the first plurality and the second plurality each define a vertex of an imaginary triangle.

7. The multi-lumen port as defined in claim 6, wherein at least one protrusion of the first plurality and the second plurality are positioned substantially on a long axis of the port.

8. The multi-lumen port as defined in claim 6, wherein the imaginary triangles of the first plurality and the second plurality are mirror images of one another.

9. The multi-lumen port as defined in claim 1, wherein the characteristic of one of the first septum and the second septum with respect to the other septum is the position of the first septum with respect to the position of the second septum.

10. The multi-lumen port as defined in claim 1, wherein the characteristic of one of the first septum and the second septum with respect to the other septum is the orientation of the port including the first septum and the second septum within the body of the patient.

11. The multi-lumen port as defined in claim 1, wherein the protrusions of at least one of the first plurality and the second plurality define end points of an imaginary shape selected from the group consisting of a line, a triangle, a square, a circle and a geometric shape.

12. A multi-lumen access port comprising:

a housing defining a first reservoir and a second reservoir;

a first septum coupled with the housing and configured to provide selective access to the first reservoir, the first septum including a first plurality of protrusions defined about a periphery of the first septum; and

a second septum coupled with the housing and configured to provide selective access to the second reservoir, the second septum including a second plurality of protrusions defined about a periphery of the second septum, wherein the protrusions of the first plurality and the second plurality are palpable after implantation of the port in a patient to determine a relative position of the first septum with respect to the second septum.

13. The access port as defined in claim 12, wherein the protrusions of the first plurality and the second plurality each define end points of an identical imaginary shape.

14. The access port as defined in claim 12, wherein each of the first plurality and the second plurality includes three protrusions.

15. The access port as defined in claim 14, wherein the three protrusions of each of the first plurality and the second plurality substantially define vertices of an imaginary triangle.

16. The access port as defined in claim 15, wherein the imaginary triangles substantially defined by the three protrusions of each of the first plurality and the second plurality are arranged so as to be substantially bisected by a long axis of the port.

17. The access port as defined in claim 15, wherein a top vertex of each imaginary triangle defined by the protrusions of each of the first plurality and the second plurality substantially lies along the long axis such that the imaginary triangles point toward each other.

18. The access port as defined in claim 12, wherein the housing further defines a palpable ridge extending between the first septum and the second septum.

19. The access port as defined in claim 12, wherein the port is a dual lumen port.

20. The access port as defined in claim 12, wherein a periphery of the protrusions of the first plurality define a first pattern, wherein a periphery of the protrusions of the second plurality define a second pattern, wherein protrusions of the first and second pluralities cooperate to produce additional patterns, each of the additional patterns being distinct from the first and second patterns.

21. The access port as defined in claim 20, wherein the first and second patterns are substantially the same.

22. The access port as defined in claim 12, wherein the protrusions are substantially hemispherical in shape.

23. The access port as defined in claim 12, wherein the protrusions are shaped to prevent tissue irritation when the access port is implanted in a body of a patient.

24. The access port as defined in claim 12, wherein the protrusions are integrally formed with the respective one of the first and second septum.

25. A multi-lumen access port comprising:

a housing defining at least a first reservoir and a second reservoir;

a first septum coupled with the housing and configured to provide selective access to the first reservoir;

a second septum coupled with the housing and configured to provide selective access to the second reservoir; and

an indicator that is radiographically visible relative to the housing, the indicator including a first portion and a second portion, wherein the first portion includes information regarding the first septum and first reservoir, and wherein the second portion includes information regarding the second septum and second reservoir.

26. The access port as defined in claim 25, wherein the first portion and the second portion indicate an orientation of the port after implantation in a patient.

27. The access port as defined in claim 25, wherein the first portion and the second portion indicate compatibility of the access port to power injection of fluids therethrough.

28. The access port as defined in claim 25, wherein radiographic observation of the indicator indicates if the access port is in a flipped orientation after implantation in a patient.

29. The access port as defined in claim 25, wherein the housing except for the indicator is radio-translucent.

30. The access port as defined in claim 25, wherein the housing includes a polymer material.

31. The access port as defined in claim 25, wherein the first portion is integrally formed with the second portion.

32. The access port as defined in claim 25, wherein the indicator includes a recess defined in the housing, the recess being radiographically visible relative to other portions of the housing.

33. The access port as defined in claim 32, wherein the housing includes titanium.

34. The access port as defined in claim 25, wherein the indicator includes a substantially rigid radiopaque component that is attached to a portion of the housing.

35. The access port as defined in claim 34, wherein the radiopaque component includes a metallic substance.

36. The access port as defined in claim 35, wherein the radiopaque component includes titanium.

37. The access port as defined in claim 34, wherein the first portion and the second portion are triangularly shaped.

38. The access port as defined in claim 34, wherein the radiopaque component further includes alphanumeric indicia with at least one of the first portion and the second portion.

39. The access port as defined in claim 38, wherein the alphanumeric indicia include a letter “

C” and

a letter “

T.”

40. The access port as defined in claim 38, wherein the alphanumeric indicia are in a reverse configuration such that the alphanumeric indicia are in a non-reverse configuration when viewed on a radiographic image.

41. The access port as defined in claim 34, wherein the radiopaque component is received in a cavity defined on a bottom surface of the housing.

42. The access port as defined in claim 41, wherein the radiopaque component is attached to the housing within the cavity by ultrasonic bonding.

43. The access port as defined in claim 34, wherein the bottom surface of the housing is defined by the base and a cap joined to the base, and wherein the radiopaque component includes at least a portion thereof that extends beyond a periphery of the base and is received in a cavity defined by the cap.

44. The access port as defined in claim 34, further comprising a plurality of protrusions defined on the first septum and the second septum, the protrusions being palpable after implantation of the dual lumen port to provide information of a position of the first septum relative to the second septum.

45. The access port as defined in claim 25, wherein the indicator provides information relating to a number of septa included in the access port.

46. The access port as defined in claim 25, wherein the indicator includes a radiopacity relatively greater than that of the housing.

47. The access port as defined in claim 25, wherein the indicator includes a radiopacity relatively less than that of the housing.

48. A method of determining information regarding a multi-lumen access port, the method comprising:

providing a subcutaneously implanted port comprising a first septum and a second septum, the port further comprising an indicator including a first portion and a second portion, the indicator providing information of a characteristic of at least one of the first septum and the first reservoir with respect to a characteristic of at least one of the second septum and the second reservoir; and

radiographically imaging the implanted port to form an image of the indicator.

49. The method of claim 48, further comprising interpreting the image of the indicator.