Shield assembly with removable inner-tube apparatus for radioactive stents

• US 6,190,303 B1
• Filed: 04/28/1999
• Issued: 02/20/2001
• Est. Priority Date: 01/25/1999
• Status: Expired due to Fees

• Current Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Original Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Inventors: Glenn, Richard A., Campbell, Thomas H., Turnlund, Todd H.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/301,442
• Time in Patent Office: 664 Days
• Field of Search: 600/1, 600/3, 600/104, 600/107, 600/108
• US Class Current: 600/3
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: G21F 5/018 Syringe shields or holders syringe shielding for applying radioactive material to the body A61M5/1785

Abstract

A radiation shield assembly (30) for a radioactive stent (11) mounted onto a deployment portion (20) of a delivery apparatus (12) including a relatively thin, elongated tube member (69) having a wall (70) defining a receiving passage (72) formed and dimensioned for axial receipt of the stent mounted onto the deployment portion therein to substantially prevent direct contact with the stent (11). A removal structure (71) cooperating with the wall (70) of the tube member (69) for longitudinal severing thereof to enable selective removal of the tube member from the delivery apparatus (12) for deployment use thereof.

Claims

1. A radiation shield assembly for a deformable stent mounted onto a deployment portion of a delivery apparatus comprising:

an elongated tube member defining a receiving passage formed and dimensioned for axial receipt of the stent mounted onto the deployment portion of the delivery apparatus therein to substantially prevent exposure to radiation of the stent, said tube member having a relatively thin wall portion, relative the length thereof, extending longitudinally from substantially one end of the tube member to an opposite end thereof; and

removal structure cooperating with the thin wall portion of the tube member for longitudinal severing of the thin wall portion substantially from the one end of the tube member to the opposite end thereof to enable selective removal of the tube member from the delivery apparatus for deployment use thereof.

2. The radiation shield assembly according to claim 1 wherein,

said tube member is deformable and adapted to peeled-away from the delivery apparatus upon severing of the wall portion.

3. The radiation shield assembly according to claim 1 wherein,

said tube member is deformable and adapted to be torn away from the delivery apparatus upon severing of the wall portion.

4. The radiation shield assembly according to claim 1, wherein

said tube member is formed for an interference fit with one of the mounted stent and the deployment portion of the delivery apparatus.

5. The radiation shield assembly according to claim 1 wherein,

said tube member is composed of a flexible polymer material having a wall thickness in the range of about 2.0 Mils to about 40 Mils.

6. The radiation shield assembly according to claim 3 wherein,

said removal structure includes a tab member coupled to said tube member to enable gripping thereof for said severing of the tube member wall portion.

7. The radiation shield assembly according to claim 6 wherein,

said removal structure further includes a longitudinally extending perforation to facilitate separation of the delivery apparatus from the tube member during the severing motion.

8. The radiation shield assembly according to claim 1 wherein,

said removal structure includes a longitudinally extending perforation to facilitate severing of the tube member wall during removal of the delivery apparatus from the tube member.

9. The radiation shield assembly according to claim 1 wherein,

said removal structure includes a pair of opposed tab members coupled to said tube member to enable opposed gripping thereof for said severing of the tube member wall portion.

10. The radiation shield assembly according to claim 9 wherein,

said removal structure further includes a pair of opposed longitudinally extending perforations each respectively positioned between said tab members to facilitate separation of the tube member from the stent during the removal thereof.

11. The radiation shield assembly according to claim 1 wherein,

said tube member includes a relatively rigid first tube section, and an opposed relatively rigid second tube section which together cooperate, in a closed condition, to define the receiving passage for receipt of said stent and said deployment portion therein, and

said removal structure including a bonding material cooperating with the first and second tube sections to retain said tube member in the closed condition, said bonding material further adapted to enable separation of the opposed first and second tube sections, to an opened condition, upon application of sufficient separation forces to overcome the bonding strength of the bonding material to sever said wall portion.

12. The radiation shield assembly according to claim 11 wherein,

each said first tube section and said second tube section includes longitudinally extending first edge and an opposite longitudinally extending second edge wherein, in the closed condition, the respective first edges and the respect second edges are positioned adjacent one another, and said bonding material is disposed respectively therebetween for bonding thereof.

13. The radiation shield assembly according to claim 12 wherein,

said first and second tube sections are comprised of metal.

14. The radiation shield assembly according to claim 1 further including:

a retaining mechanism coupled to said tube member and adapted to selectively prevent axial displacement between the deployment portion of the delivery apparatus and the tube member.

15. The radiation shield assembly according to claim 14 wherein,

said retaining mechanism is movable between an engaged condition, preventing axial displacement between the stent and deployment portion of the delivery apparatus contained in the tube member passage, and a disengaged condition, permitting axial displacement therebetween.

16. The radiation shield assembly according to claim 15 wherein,

said retaining mechanism includes a pair of opposed engaging fingers configured to contact the delivery apparatus for frictional engagement therewith in the engaged condition.

17. The radiation shield assembly according to claim 16 wherein,

each engaging finger includes a seal member configured to cooperate with one another to form a hemostatic seal with said delivery apparatus when positioned in the engaged condition to seal the proximal end of said passage.

18. The radiation shield assembly according to claim 17 wherein,

each seal member is provided by an elastomeric seal positioned at opposing distal ends of the respective engaging fingers.

19. The radiation shield assembly according to claim 16 wherein,

each engaging finger is movably mounted to the tube member between the engaged condition and the disengaged condition in directions toward and away from the delivery apparatus.

20. The radiation shield assembly according to claim 19 wherein,

said retaining mechanism further includes a lock device coupled to the engaging fingers for selective locking thereof in the engaged condition.

21. The radiation shield assembly according to claim 14 wherein,

said retaining mechanism is positioned proximate a proximal section of said tube member, and includes a seal device adapted to form a hemostatic seal with said delivery apparatus when in the engaged condition to seal the proximal end of said passage.

22. The radiation shield assembly according to claim 9 further including:

a retaining mechanism coupled to the opposed tab members and adapted to selectively prevent axial displacement between the deployment device and the tube member.

23. The radiation shield assembly according to claim 22 wherein,

said retaining mechanism is movable between an engaged condition, preventing axial displacement between the stent and deployment device contained in the tube member passage, and a disengaged condition, permitting axial displacement therebetween.

24. The radiation shield assembly according to claim 23 wherein,

said retaining mechanism includes a pair of opposed engaging fingers each coupled to a respective tab member, and configured to contact the delivery apparatus for frictional engagement therewith in the engaged condition.

25. The radiation shield assembly according to claim 24 wherein,

each engaging finger includes a seal member configured to cooperate with one another to form a hemostatic seal with said delivery apparatus when positioned in the engaged condition to seal the proximal end of said passage.

26. The radiation shield assembly according to claim 24 wherein,

each engaging finger is movably mounted to the respective tab member between the engaged condition and the disengaged condition in directions toward and away from the delivery apparatus.

27. The radiation shield assembly according to claim 26 wherein,

said retaining mechanism further includes a lock device coupled to the engaging fingers for selective locking thereof in the engaged condition.

28. A radiation shield assembly for a deformable radioactive stent mounted onto a deployment portion of a delivery apparatus comprising:

an elongated tube member having a wall defining a receiving passage formed and dimensioned for axial receipt of the stent mounted onto the deployment portion of the delivery apparatus therein; and

radiation shield device removably disposed peripherally about at least a portion of said elongated tube member such that said stent and said deployment portion are substantially contained within said shield device to substantially prevent the passage of radioisotopes emitted from the stent radially out of said shield device.

29. The radiation shield assembly according to claim 28 wherein,

said tube member includes removal structure cooperating with the wall of the tube member for longitudinal severing thereof to enable selective removal of the tube member from the delivery apparatus for deployment use thereof.

30. The radiation shield assembly according to claim 29 wherein,

said tube member is adapted to peeled-away from the delivery apparatus upon severing of the wall.

31. The radiation shield assembly according to claim 29 wherein,

said tube member is adapted to be torn away from the delivery apparatus upon severing of the wall.

32. The radiation shield assembly according to claim 31 wherein,

said removal structure includes a tab member coupled to said tube member to enable gripping thereof for said severing of the tube member wall.

33. The radiation shield assembly according to claim 32 wherein,

said removal structure further includes a longitudinally extending perforation to facilitate separation of the delivery apparatus from the tube member during the severing motion.

34. The radiation shield assembly according to claim 31 wherein,

said tube member is sufficiently radially rigid to substantially withstand radial compressive forces in the range of about 0.1 to about 20 lbs.

35. The radiation shield assembly according to claim 34 wherein,

said tube member is composed of a flexible polymer material having a wall thickness in the range of about 2.0 mils inch to about 40.0 mils.

36. The radiation shield assembly according to claim 31 wherein,

said tube member includes a distal proboscis portion adapted to extend distally from said radiation shield when said stent is contained therein.

37. The radiation shield assembly according to claim 36 wherein,

said tab member is positioned on a proximal section of the tube member.

38. The radiation shield assembly according to claim 28 wherein,

said radiation shield device is configured to enable said delivery apparatus and the mounted tube member to be axially displaceable therewith.

39. The radiation shield assembly according to claim 28 wherein,

said radiation device includes a first shield member having a first mating surface, and a second shield member removably coupled to said first shield member, and having an opposed second mating surface cooperating with said first mating surface to substantially radially enclose the tube member and contained stent therebetween.

40. The radiation shield assembly according to claim 39 wherein,

said first mating surface and said second mating surface further cooperate to define a channel therebetween, formed and dimensioned for longitudinal receipt of the tube member therein.

41. The radiation shield assembly according to claim 40 further including:

a coupling device movably coupling said second shield member to the first shield member between a closed position, enclosing at least said tube member and the stent in said channel, and an opened position, enabling removal of said tube member from said shield device.

42. The radiation shield assembly according to claim 40 wherein,

said tube member includes a distal proboscis portion adapted to extend distally from said channel of the radiation shield when said stent is contained therein.

43. The radiation shield assembly according to claim 42 wherein,

said tube member includes removal structure adapted to enable removal of the tube member from the delivery apparatus.

44. The radiation shield assembly according to claim 43, wherein

said tube member is adapted to be torn away from the delivery apparatus upon severing of the wall.

45. The radiation shield assembly according to claim 44 wherein,

said removal structure includes a tab member coupled to said tube member to enable gripping thereof for said severing of the tube member wall.

46. The radiation shield assembly according to claim 45 wherein,

said removal structure further includes a longitudinally extending perforation to facilitate separation of the delivery apparatus from the tube member during the severing motion.

47. The radiation shield assembly according to claim 28 further including:

a retaining mechanism coupled to said tube member and adapted to selective prevent axial displacement between the deployment device and the tube member.

48. The radiation shield assembly according to claim 47 wherein,

said retaining mechanism is movable between an engaged condition, preventing axial displacement between the stent and deployment device contained in the tube member passage, and a disengaged condition, permitting axial displacement therebetween.

49. A method of storing a deformable stent mounted onto a deployment portion of a delivery apparatus for transport and delivery comprising:

containing the stent and the deployment device into an axially extending receiving passage of a relatively thin, elongated tube member to substantially prevent direct contact with the stent; and

providing removal structure cooperating with a wall of the tube member for longitudinal severing thereof to enable selective removal of the delivery apparatus from the tube member for deployment use thereof.

50. A method of delivering a deformable radioactive stent mounted onto a deployment portion of a delivery apparatus into a vessel comprising:

containing the stent and the deployment device in a passage of an elongated tube member to substantially prevent direct contact with the stent;

placing a proboscis portion of the tube member in communication with a fitting for receipt into the vessel;

axially advancing the mounted stent and the deployment device, relative the tube member, into the fitting; and

removing the tube member from impeding contact with the delivery apparatus.

51. The method of claim 50 wherein,

said placing a proboscis portion includes slideably inserting the proboscis portion into an opening of the fitting to enable sliding axial receipt of the stent and deployment portion therein.

52. The method of claim 50 wherein,

before the removing the tube member, withdrawing the proboscis portion of the tube member from communication with the fitting.

53. The method of claim 50 wherein,

said removing the tube member includes longitudinal severing a wall of the tube member to enable the selective removal of the delivery apparatus from the tube member passage.

54. The method of claim 53 wherein,

said longitudinal severing includes tearing-away the wall of the tube member to enable the selective removal of the delivery apparatus from the tube member passage.

55. The method of claim 54 wherein,

said severing a wall includes pulling a tab member integrally formed in the wall of the tube member to enable severing of the tube member wall.

56. The method of claim 54 wherein,

said severing a wall further includes severing the wall along a longitudinally extending perforation predisposed in the wall to facilitate separation of the delivery apparatus from the tube member during the severing motion.

57. The method of claim 50 wherein,

the containing the stent and deployment device further includes containing at least a portion of said elongated tube member in a radiation shield device removably disposed peripherally about tube member such that said stent and said deployment portion are substantially contained within said shield device to substantially prevent the passage of radioisotopes emitted from the stent radially out of said shield device.

58. The method of claim 57 wherein,

before the removing the tube member, removing the radiation shield device from contact with the delivery apparatus.

59. The method of claim 57 wherein,

said radiation shield device includes a first shield member having a first mating surface, and a second shield member an opposed second mating surface, said second shield member be movably coupled to said first shield member between a closed condition, substantially radially enclosing at least a portion of the tube member and the contained stent therebetween, and an opened condition, enabling removal of the tube member from the shield device, and

said removing the radiation shield device includes moving the shield device from the closed condition to the opened condition.

60. The method of claim 59 wherein,

said removing the tube member includes longitudinal severing a wall of the tube member to enable the selective removal of the delivery apparatus from the tube member passage.

61. The method of claim 50 wherein,

the containing the stent and deployment device further includes locking the delivery apparatus to the tube member, through a retaining mechanism, to substantially prevent axial displacement of the mounted stent and deployment device contained in the tube member passage;

and

before the axially advancing the mounted stent and the deployment device, disengaging the retaining mechanism to permit axial displacement of the mounted stent and deployment device relative the tube member passage.

62. A shield assembly for a deformable stent mounted onto a deployment portion of a delivery apparatus comprising:

a relatively thin, elongated tube member having a wall defining a receiving passage formed and dimensioned for axial receipt of the stent mounted onto the deployment portion of the delivery apparatus therein to substantially prevent direct contact with the stent;

removal structure cooperating with the wall of the tube member for longitudinal severing thereof to enable selective removal of the tube member from the delivery apparatus for deployment use thereof; and

a retaining mechanism having a pair of opposed engaging fingers movable between an engaged condition, adapted to contact the delivery apparatus for frictional engagement therewith to prevent axial displacement of the stent and delivery apparatus relative the tube member, and a disengaged condition, permitting axial displacement therebetween.

63. The radiation shield assembly according to claim 62 wherein,

said tube member is deformable and adapted to peeled-away from the delivery apparatus upon severing of the wall.

64. The radiation shield assembly according to claim 62 wherein,

said tube member is deformnable and adapted to be torn away from the delivery apparatus upon severing of the wall.

65. The radiation shield assembly according to claim 62, wherein

said tube member is formed for an interference fit with one of the mounted stent and the deployment portion of the delivery apparatus.

66. The radiation shield assembly according to claim 64 wherein,

said removal structure includes a tab member coupled to said tube member to enable gripping thereof for said severing of the tube member wall.

67. A shield assembly for a deformable stent mounted onto a deployment portion of a delivery apparatus comprising:

a relatively thin, elongated tube member having a wall defining a receiving passage formed and dimensioned for axial receipt of the stent mounted onto the deployment portion of the delivery apparatus therein to substantially prevent direct contact with the stent;

removal structure cooperating with the wall of the tube member for longitudinal severing thereof to enable selective removal of the tube member from the delivery apparatus for deployment use thereof;

a retaining mechanism positioned proximate a proximal section of said tube member and coupled thereto to selectively prevent axial displacement between the deployment device and the tube member, said retaining device further including a seal device adapted to form a hemostatic seal with said delivery apparatus when in the engaged therewith to seal the proximal end of said passage.

68. The radiation shield assembly according to claim 67 wherein,

said tube member is deformable and adapted to peeled-away from the delivery apparatus upon severing of the wall.

69. The radiation shield assembly according to claim 67 wherein,

said tube member is deformable and adapted to be torn away from the delivery apparatus upon severing of the wall.

70. The radiation shield assembly according to claim 67, wherein

said tube member is formed for an interference fit with one of the mounted stent and the deployment portion of the delivery apparatus.

71. The radiation shield assembly according to claim 69 wherein,

said removal structure includes a tab member coupled to said tube member to enable gripping thereof for said severing of the tube member wall.