Echogenic medical device

• US 8,560,052 B2
• Filed: 04/20/2004
• Issued: 10/15/2013
• Est. Priority Date: 06/07/2001
• Status: Expired due to Term

• Current Assignee: Cowles Ventures LLC
• Original Assignee: Core Oncology, Inc.
• Inventors: Mills, Stanley L.
• Primary Examiner(s): Jung, Unsu
• Assistant Examiner(s): Lamprecht, Joel
• Application Number:
  US10/828,539
• Publication Number:
  US 20050049490A1
• Time in Patent Office: 3,465 Days
• Field of Search: 600/407, 600/410, 600/437, 600 1- 8, 600/431, 600/458, 128/653, 128/654, 427/5, 424/1, 424/9, 424/1.11, 606/77
• US Class Current: 600/431
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures

Abstract

Echogenic medical devices, methods of fabrication and methods of use are disclosed. The device can be adapted to be inserted into a patient. The echogenic construction can be incorporated into the device at the time of fabrication providing acoustic impedance different from that of the surrounding biological tissue or fluid. The medical device is designed for use with an ultrasound imaging system to provide real-time location of the insertion and guidance at the time the device is implanted in a patient, such as in brachytherapy. Following placement of the device the position can be evaluated over time to insure the device remains in proper alignment and functional. Furthermore, the device is designed to incorporate a spacer element at one or both ends to provide separation between radioactive elements.

Claims

1. An implantable brachytherapy seed device configured to be imaged, the device comprising:

a parabolic surface defining a hermetically sealed body chamber filled with a gas; and

a radioisotopic component inside the body chamber that is surrounded by the gas wherein the gas has a density difference with the body chamber and the tissue into which the implantable brachytherapy seed device is implantable so that the implantable brachytherapy seed is more easily imagable using acoustic energy, the medical device having a proximal and a distal end and the medical device is capable of being implanted into a live body.

2. The device of claim 1, where the radioisotopic component comprises ²⁶Al, ¹⁹⁸Au, ¹¹⁵Cd, ¹³⁷Cs, ¹²⁵I, ¹⁹²Ir, ⁴⁰K, ³²P, ¹⁰³Pd, ⁸⁶Rb, ¹²³Sn, ⁸⁹Sr, ⁹⁰Sr, ¹²⁵Te, ⁹⁰Y, ⁹¹Y, ¹⁶⁹Yb or a combination of these.

3. The device of claim 2, where the radioisotopic component comprises ¹²⁵I or ¹⁰³Pd.

4. The device of claim 1, where the device comprise at least one spacer element connected to the body chamber.

5. The device of claim 4, further comprising at least one spacer element at the proximal end of the device.

6. The device of claim 4, further comprising at least one spacer element at the said distal end of the device.

7. The device of claim 4, further comprising a plurality of parabolic surfaces, each parabolic surface defining a body chamber.

8. The device of claim 7, where one body chamber is connected to a spacer element that is connected to at least a second body chamber.

9. The device of claim 4, the spacer element further comprising a contrast material.

10. The device of claim 9, where the contrast material is silver, gold, or tungsten.

11. The device of claim 4, further comprising a docking guide that is operatively attached to the spacer element or to the body chamber where the docking guide is at the proximal end of the device.

12. The device of claim 11, wherein the docking guide accepts a radioactive source or a spacer.

13. The device of claim 11, wherein the docking guide fixes the medical device in tissue when the medical device is implanted into a live body.

14. The device of claim 11, where the docking guide comprises a flexible joint.

15. The device of claim 11, where the docking guide comprises a non-locking docking port.

16. The device of claim 1, further comprising a plurality of spacer elements.

17. The device of claim 16, wherein the plurality of spacer elements further comprises at least one spacer element at the proximal end and at least one spacer element at the distal end of the device.

18. The device of claim 1, further comprising a contrast material inside the body chamber.

19. The device of claim 18, where the contrast material further comprises a nuclear magnetic imaging contrast material.

20. The device of claim 18, where the contrast material further comprises a radiographic imaging contrast material.

21. The device of claim 1, where the device has a density of between 0.5 and 1.5 g/ml.

22. The device of claim 1, where the device has a density of between 0.8 and 1.2 g/ml.

23. The device of claim 1, where the device has a density of between 0.9 and 1.1 g/ml.

24. The device of claim 1, where the device comprises one or more synthetic polymers.

25. The device of claim 24, where the polymer is selected from the group consisting of liquid crystal polymer (LCP), Teflon, carboxylic polymers, polyacetates, polyacrylics, polyacrylamides, polyamides, polyvinylbutyrals, polycarbonates, polyethylenes, polysilanes, polyureas, polyurethanes, polyethers, polyesters, polyoxides, polystyrenes, polysulfides, polysulfones, polysulfonides, polyvinylhalides, pyrrolidones, rubbers, and thermal-setting polymers.

26. The device of claim 25, where the polymer is LCP.

27. The device of claim 26, where the LCP is an extruded LCP.

28. The device of claim 1, where the device comprises a material selected from the group consisting of albumin, cellulose, cellulose derivatives, gelatin, and gut.

29. The device of claim 1, where the device comprises one or more metals.

30. The device of claim 29, where the metal is titanium.

31. The device of claim 1, further comprising one or more voids, bubbles or channels.

32. The device of claim 31, where each void is between 0.1 mm and 0.9 mm in length.

33. The device of claim 32, where each void is about 0.5 mm in length.

34. The device of claim 32, comprising 1-10 voids.

35. The device of claim 34, comprising 1 void.

36. The device of claim 31, where each of the bubbles are between 0.001 and 0.1 mm in diameter.

37. The device of claim 36, where each of the bubbles are about 0.01 mm in diameter.

38. The device of claim 31, where each of the channels are between 0.001 and 0.1 mm in diameter.

39. The device of claim 38, where each of the channels are about 0.01 mm in diameter.

40. The device of claim 38, where each of the channels spiral at approximately 45 degree to the long axis.

41. The device of claim 1, wherein the gas is air.

42. The device of claim 1, wherein the gas is nitrogen.