Method and apparatus for locating the injection point of an implanted medical device

• US 6,287,293 B1
• Filed: 09/28/1999
• Issued: 09/11/2001
• Est. Priority Date: 09/28/1999
• Status: Expired due to Term

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Jones, Donald, Geer, Donald, Barrett, Joseph
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/382,011
• Time in Patent Office: 714 Days
• Field of Search: 604/93, 604/164, 604/167, 604/49, 604/891.1, 604/502, 604/93.01, 604/288.01, 604/288.02, 604/288.04, 604/97.03
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2039/0045 Radiopaque indicia
• 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 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A method and apparatus for locating the injection point of an implanted medical device. In a preferred embodiment, the locating apparatus is in the form of radiopaque rings made of a metallic substance. When these rings are spaced apart at different heights on an implanted medical device, such as a drug port, a stereoscopic effect results from fluoroscopically viewing the device along an axis not parallel to the axis along which the rings are spaced. This effect allows one to readily determine the orientation of the device. This prevents accidental injection of drugs into the hard backside of the drug port.

Claims

1. An implantable drug port, comprising:

a low profile housing, comprising a port top and a port base, wherein the low profile port base further comprises a low profile port stem;

a septum disposed within the housing, wherein a lumen is defined within the housing beneath the septum and accessible through the septum; and

at least two indicators disposed on the housing, spaced apart along an axis of the housing.

2. The implantable drug port according to claim 1, wherein said indicators are formed from radiopaque material.

3. The implantable drug port according to claim 2, wherein said radiopaque material further comprises radiopaque paint.

4. The implantable drug port according to claim 2, wherein the radiopaque material further comprises radiopaque plastic material, wherein a lower ring is applied to a bottom portion of the port top and an upper ring is applied to an upper portion of the port top.

5. The implantable drug port according to claim 4, wherein the low profile housing is encapsulated in a silicone rubber material.

6. The implantable drug port according to claim 4, wherein the lower ring has a discontinuity such that the discontinuity is aligned with the port stem.

7. The implantable drug port according to claim 1, wherein said indicators comprise a plurality of rings.

8.The implantable drug port according to claim 7, wherein said plurality of rings further comprises a lower ring of a first diameter disposed near a bottom of said drug port and an upper ring of a second diameter, different from said first diameter, disposed near a top of said drug port.

9. The implantable drug port according to claim 7, wherein said plurality of rings are comprised of a metal selected from the group consisting of stainless steel, gold, platinum, tungsten tantalum and titanium.

10. The implantable drug port according to claim 7, wherein said plurality of rings are comprised of a resin and a powdered material selected from the group consisting of stainless steel, gold, platinum, tungsten tantalum, titanium and a barium compound.

11. The implantable drug port according to claim 1, wherein the indicators comprise a lower locator ring and an upper locator ring, wherein the lower locator ring is interrupted creating a discontinuity, and is disposed at a bottom of said low profile housing such that the discontinuity is aligned with the port stem, and wherein the upper locator ring is placed between the septum and the port top.

13. The implantable drug port according to claim 1, further comprising a radiopaque catheter connected to the port stem.

14. The implantable drug port according to claim 1, wherein the indicators are formed to be distinguishable from each other by imaging when said drug port is implanted.

8. The implantable drug port according to claim 8, wherein said lower ring is interrupted creating a discontinuity.

12. The implantable drug port according to claim 12, wherein the low profile housing is encapsulated with a silicone rubber material.

15. A method for determining an orientation of an implantable drug port to assist in guiding a needle into the port, wherein the implantable drug port comprises a non-inflatable housing having a first and second side, a septum disposed within the housing and a first and second indicator spaced apart along a first axis of the housing comprising the steps of:

locating the implanted non-inflatable housing;

imaging the housing along a second axis not parallel to the first axis; and

determining the orientation of the housing with respect to the first and second sides.

16. The method according to claim 16, wherein said indicators comprise radiopaque material.

19. The method according to claim 16, wherein at least one of said indicators is ring shaped.

17. The method according to claim 17, wherein said radiopaque material is selected from the group consisting of gold, platinum, tungsten, tantalum, stainless steel, titanium and barium compounds.

18. The method according to claim 17, wherein said radiopaque material further comprises radiopaque plastic material.

20. The method according to claim 20, wherein said ring shaped indicator is interrupted creating a discontinuity.

21. The method according to claim 20, wherein a radiopaque catheter is disposed to bisect said ring shaped indicator.

22. A method for guiding a needle into an implantable drug port, comprising the steps of:

providing a drug port comprising a non-inflatable housing, a septum disposed within the housing and a first and second indicator spaced apart along a first axis of the housing, wherein the indicators are distinguishable, one from the other, by an imaging technique;

implanting the drug port with the first axis normal to a patient'"'"'s skin surface;

employing the imaging technique to image the drug port along a second axis not parallel to the first axis;

determining the orientation of the drug port based on an imaged spatial relationship of the first indicator to the second indicator; and

inserting the needle into the septum at a location where the septum is accessible.

23. An implantable drug port, comprising:

a housing;

a septum disposed within the housing, wherein a lumen is defined within the housing beneath the septum and accessible through the septum; and

indicators associated with the housing, comprising a lower locator ring and an upper locator ring, wherein the rings are spaced apart along an axis of the housing, and wherein at least one of the rings is interrupted creating a discontinuity.

24. The implantable drug port according to claim 24, wherein the rings are formed from radiopaque material.

29. The implantable drug port according to claim 24, wherein the housing is encapsulated with a silicone rubber material.

30. The implantable drug port according to claim 24, further comprising a port stem, wherein the discontinuity is aligned therewith.

25. The implantable drug port according to claim 25, wherein the radiopaque material is a metal selected from the group consisting of stainless steel, gold, platinum, tungsten tantalum and titanium.

26. The implantable drug port according to claim 25, wherein the radiopaque material is a resin and a powdered material selected from the group consisting of stainless steel, gold, platinum, tungsten tantalum, titanium and a barium compound.

27. The implantable drug port according to claim 25, wherein the radiopaque material further comprises radiopaque paint.

28. The implantable drug port according to claim 25, wherein the radiopaque material further comprises radiopaque plastic material.

31. The implantable drug port according to claim 31, further comprising a radiopaque catheter, wherein the radiopaque catheter is connected to the port stem.