Seal for use with medical device and system

• US 20050090883A1
• Filed: 07/14/2003
• Published: 04/28/2005
• Est. Priority Date: 08/12/1998
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Tockman, Bruce, Westlund, Randy, Liu, Lili, Zerby, Christopher M., Crevensten, Gwen
• Granted Patent: US 7,657,324 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A seal adapted for use with medical devices is provided. The medical device may be a lead having a distal tip adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The lead assembly in one embodiment includes an atraumatic tip. A seal is provided within the lead tip assembly, which prevents or limits further entry of fluids through the lead tip. The lead may be a left ventricular lead with a hemostasis mechanism provided therewithin.

Claims

1. -39. (canceled)

40. An implantable lead for implantation by a guidewire on or about the heart, the lead comprising:

a lead body having distal and proximal ends, the lead body defining a lumen extending from a distal aperture in the distal end of the lead body toward the proximal end of the lead body;

a conductor disposed within the lead body;

an electrode disposed proximate the distal end of the lead body, the electrode electrically coupled to the conductor; and

a seal at the distal end of the lead body, the seal having an open and a closed state, wherein when the seal is in the open state the seal receives the guidewire therethrough and when the seal is in the closed state the seal prevents fluid from entering the lumen of the lead body;

wherein the seal is transitionable from the open state to the closed state.

41. The lead of claim 40, wherein the seal includes a cylindrical-shaped member having a closeable central aperture.

42. The lead of claim 40, wherein the seal includes a member coated with expandable matrix material.

43. The lead of claim 40, wherein at least a portion of the seal is formed from expandable matrix material.

44. The lead of claim 40, wherein the seal comprises a substantially rigid housing and a sealing material disposed within the housing.

45. The lead of claim 40, wherein the seal is disposed on an inner surface of the lead body.

46. The lead of claim 40, wherein the seal includes a cup-shaped member coupled with the distal end of the lead body.

47. An implantable lead for implantation by a guidewire on or about the heart, the lead comprising:

a lead body having distal and proximal ends, the lead body defining a lumen extending from a distal aperture in the distal end of the lead body toward the proximal end of the lead body,

a conductor disposed within the lead body;

an electrode disposed proximate the distal end of the lead body, the electrode electrically coupled to the conductor; and

a closable seal disposed at the distal end of the lead body, the closable seal defining a closable seal lumen for receiving the guidewire.

48. The lead of claim 47, wherein the closable seal includes a cylindrical-shaped member.

49. The lead of claim 47, wherein the closable seal includes a member coated with expandable matrix material.

50. The lead of claim 47, wherein at least a portion of the closable seal is formed from an expandable matrix material.

51. The lead of claim 47, wherein the closable seal comprises a substantially rigid housing and a sealing material disposed within the housing.

52. The lead of claim 47, wherein the closable seal is disposed on an inner surface of the lead body.

53. The lead of claim 47, wherein the closable seal includes a cup-shaped member coupled with the distal end of the lead body.

54. An implantable lead for implantation by means of a guidewire on or about the heart, the lead comprising:

a lead body having distal and proximal ends, the lead body defining a lumen extending from a distal aperture in the distal end of the lead body toward the proximal end of the lead body;

a conductor disposed within the lead body;

an electrode disposed proximate the distal end of the lead body, the electrode electrically coupled to the conductor; and

a seal at the distal end of the lead body, the seal having a first state wherein the seal

defines an aperture to receive the guidewire, the seal having a second state wherein the seal limits the flow of fluids into the lead body.

55. The lead of claim 54, wherein the seal aperture is adapted to close when the guidewire is removed from the aperture.

56. The lead of claim 54, wherein the seal includes a member coated with expandable matrix material.

57. The lead of claim 54, wherein at least a portion of the seal is formed from an expandable matrix material.

58. The lead of claim 54, wherein the seal comprises a substantially rigid housing and a sealing material disposed within the housing.

59. The lead of claim 54, wherein the seal is disposed on an inner surface of the lead body.

60. The lead of claim 54, wherein the seal includes a cup-shaped member coupled with the distal end of the lead body.

61. A method of implanting a lead on or about the heart, the method comprising:

disposing a guidewire through a lead, the lead having at least one electrode, the lead defining a lumen which extends from an aperture at a distal tip of the lead toward a proximal end of the lead, the lead also including a seal disposed at the distal tip of the lead, the seal defining a seal lumen;

disposing the guidewire through the seal lumen;

guiding the lead with the guidewire to a desired location on or about the heart,

after the lead is guided to the desired location, removing the guidewire from the seal lumen whereupon the seal closes to prevent fluids from entering the lumen.

62. The method of claim 61, wherein the seal closes by the seal expanding until the seal lumen is closed.

63. The method of claim 61, wherein the seal closes by having at least a portion of the seal formed from an expandable matrix material which expands when the guidewire is removed from the seal lumen.

64. The method of claim 61, further comprising transitioning the seal from an open position to a closed position, and preventing fluids from entering the lumen in the closed position.