Device for use in right ventricular placement and method for using same

• US 5,639,276 A
• Filed: 09/23/1994
• Issued: 06/17/1997
• Est. Priority Date: 09/23/1994
• Status: Expired due to Fees

• Current Assignee: Rapid Development Services Incorporated MO Corporation
• Original Assignee: Rapid Development Services Incorporated MO Corporation
• Inventors: Weinstock, Barry S., Maxson, Christopher C.
• Primary Examiner(s): Rimell, Sam
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US08/311,680
• Time in Patent Office: 998 Days
• Field of Search: 606/129, 607/116, 607/122, 607/123, 604/264, 128/772
• US Class Current: 606/129
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A device and method for rapid, atraumatic placement of medical devices in the right ventricle of a patient. The device includes an introducer sheath used as a passage for intravenous placement of a medical device in a patient'"'"'s heart. The introducer sheath is of sufficient length to allow a proximal end thereof to be located outwardly from an incision in the skin of a patient over the cephalic vein when a distal end of the introducer sheath is at the apex of the right ventricle. The introducer sheath is of sufficient flexibility to pass through the tricuspid valve and through the narrow passage between the clavicle and first rib, and is of sufficient strength to allow the introducer sheath to be pushed along its length thereof through the tortuous path from the incision over the cephalic vein to the apex of the right ventricle. The introducer sheath has an inside diameter of sufficient size to slidably receive a balloon-tipped catheter, a guidewire, a pacing lead, or the like therein.

Claims

1. A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising:

an introducer sheath used as a passage for transvenous placement of a medical device in a patient'"'"'s heart, the introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle;

said introducer sheath having an inside diameter of sufficient size to slidably receive a balloon-tipped catheter or pacing lead therethrough.

2. The device of claim 1 further comprising:

a balloon-tipped catheter within said introducer sheath.

3. The device of claim 1 further comprising:

a radio opaque marker at the distal end of said introducer sheath.

4. The device of claim 1 further comprising:

at least one radio opaque marker spaced from the distal end of said introducer sheath.

5. The device of claim 1 wherein said introducer sheath is radio opaque along at least a portion of its length.

6. The device of claim 1 further comprising:

a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.

7. The device of claim 1 further comprising:

a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.

8. The device of claim 1 further comprising:

a flange attached to the proximal end of said introducer sheath.

9. The device of claim 8 further comprising:

a dilator having a tapered distal end, a central bore of sufficient size to pass a guide member therethrough, and being of sufficient length to extend from a proximal end located at a point beyond said proximal end of said introducer sheath past the distal end of said introducer sheath;

said introducer sheath having an inside diameter configured for a close fit of said dilator in said introducer sheath.

10. The device of claim 9 further comprising:

a clip attached to the proximal end of said dilator for detachably mating with said flange attached to the proximal end of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.

11. The device of claim 10 further comprising:

a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.

12. The device of claim 9 wherein the gradient of stiffness comprises one of the following:

a wall thickness of the introducer sheath which decreases from the proximal end to the distal end;

a wall thickness of the introducer sheath which decreases along at least a portion of its length;

an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant;

an outside diameter of the introducer sheath which decreases along at least a portion of its length while the inside diameter of the introducer sheath remains constant;

stiffness which varies along the length of the introducer sheath from the proximal end to the distal end;

stiffness which varies along at least a portion of the introducer sheath;

stiffness which varies gradually;

stiffness which varies in one incremental step;

stiffness which varies in a plurality of steps;

a material of varying density;

a material of varying polymer or metal composition mixture; and

a material having a varied degree of cross-linking.

13. The device of claim 12 wherein the dilator varies in stiffness along at least a portion of its length.

14. The device of claim 1 wherein said length of said introducer sheath is at least 40 cm.

15. The device of claim 1 wherein the inside of said introducer sheath is a low-friction surface.

16. The device of claim 1 wherein said inside diameter of said introducer sheath is at least 1.65 mm.

17. The device of claim 1 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient'"'"'s right side.

18. The device of claim 1 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient'"'"'s left side.

19. The device of claim 1 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.

20. A device for use in rapid, atraumatic placement of medical devices in a right ventricle of a patient comprising:

an introducer sheath used as a passage for transvenous placement of a medical device in a patient'"'"'s heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a soft and flexible distal end of said introducer sheath is at an apex of the right ventricle, said introducer sheath having sufficient flexibility to pass atraumatically through a tricuspid valve and having sufficient strength to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle;

said introducer sheath having a gradient of stiffness which decreases toward the distal end along at least a portion of its length and an inside diameter of sufficient size to pass a removable flexible guidewire therethrough.

21. The device of claim 20 further comprising:

a removable flexible guidewire slidably received in said introducer sheath.

22. The device of claim 21 wherein said removable flexible guidewire is an angled, J-tipped guidewire.

23. The device of claim 20 further comprising:

a radio opaque marker at the distal end of said introducer sheath.

24. The device of claim 20 further comprising:

at least one radio opaque marker spaced from the distal end of said introducer sheath.

25. The device of claim 20 wherein said introducer sheath is radio opaque along at least a portion of its length.

26. The device of claim 20 further comprising:

a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.

27. The device of claim 20 further comprising:

a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.

28. The device of claim 20 further comprising:

a flange attached to the proximal end of said introducer sheath.

29. The device of claim 28 further comprising:

a dilator having a tapered distal end, a central bore of sufficient size to pass said guidewire therethrough, and being of sufficient length to extend from a proximal end located at a point beyond said proximal end of said introducer sheath past the distal end of said introducer sheath;

said introducer sheath having an inside diameter configured for a close fit of said dilator in said introducer sheath.

30. The device of claim 29 further comprising:

a clip attached to the proximal end of said dilator for detachably mating with said flange attached to the proximal end of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.

31. The device of claim 29 further comprising:

a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.

32. The device of claim 29 wherein the dilator varies in stiffness along at least a portion of its length.

33. The device of claim 20 wherein said length of said introducer sheath is at least 40 cm.

34. The device of claim 20 wherein the inside of said introducer sheath is a low-friction surface.

35. The device of claim 20 wherein said inside diameter of said introducer sheath is at least 0.66 mm.

36. The device of claim 20 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient'"'"'s right side.

37. The device of claim 20 wherein said introducer sheath has a length sufficient to extend from the apex of the right ventricle to outwardly of an incision over the cephalic vein on the patient'"'"'s left side.

38. The device of claim 20 wherein the varying stiffness comprises one of the following:

a wall thickness of the introducer sheath which decreases from the proximal end to the distal end;

an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant;

stiffness which varies gradually;

stiffness which varies in one incremental step;

stiffness which varies in a plurality of steps;

a material of varying density;

a material of varying polymer or metal composition mixture; and

a material having a varied degree of cross-linking.

39. The device of claim 20 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.

40. A kit for rapid, atraumatic right ventricular placement of medical devices comprising:

a guide member;

a dilator having a tapered distal end and a central bore of sufficient size for passing the guide member therethrough; and

an introducer sheath used as a passage for transvenous placement of a medical device in a patient'"'"'s heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter configured for a close fit of said dilator therein;

said dilator having a length greater than the length of the introducer sheath.

41. The kit of claim 40 further comprising:

a flange on the proximal end of said introducer sheath; and

a clip attached to a proximal end of said dilator for detachably mating with said flange of said introducer sheath to prevent separation of said dilator and introducer sheath during manipulation.

42. The kit of claim 41 further comprising a balloon-tipped catheter sized to fit within said introducer sheath.

43. The kit of claim 41 further comprising:

at least one radio opaque marker spaced from the distal end of said introducer sheath.

44. The kit of claim 40 wherein said guide member is a flexible guidewire.

45. The kit of claim 44 wherein said flexible guidewire is angled and J-tipped.

46. The kit of claim 40 further comprising a hollow needle having an inside diameter sufficient to pass said guide member therethrough.

47. The kit of claim 40 further comprising a permanent pacemaker set.

48. The kit of claim 40 further comprising:

a radio opaque marker at the distal end of said introducer sheath.

49. The kit of claim 40 wherein said introducer sheath is radio opaque along at least a portion of its length.

50. The kit of claim 40 further comprising:

a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart.

51. The kit of claim 40 further comprising:

a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away.

52. The kit of claim 40 further comprising:

a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient.

53. The kit of claim 40 wherein the gradient of stiffness comprises one of the following:

a wall thickness of the introducer sheath which decreases from the proximal end to the distal end;

a wall thickness of the introducer sheath which decreases along at least a portion of its length;

an outside diameter of the introducer sheath which decreases from the proximal end to the distal end while the inside diameter of the introducer sheath remains constant;

an outside diameter of the introducer sheath which decreases along at least a portion of its length while the inside diameter of the introducer sheath remains constant;

stiffness which varies along the length of the introducer sheath from the proximal end to the distal end;

stiffness which varies along at least a portion of the introducer sheath;

stiffness which varies gradually;

stiffness which varies in one incremental step;

stiffness which varies in a plurality of steps;

a material of varying density;

a material of varying polymer or metal composition mixture; and

a material having a varied degree of cross-linking.

54. The kit of claim 40 wherein the dilator varies in stiffness along at least a portion of its length.

55. The kit of claim 40 wherein said guide member is a balloon-tipped catheter sized to fit within said introducer sheath.

56. The kit of claim 40 further comprising a flexible guidewire.

57. The kit of claim 56 wherein said flexible guidewire is angled and J-tipped.

58. The kit of claim 40 wherein a distal portion of the introducer sheath that extends from the superior vena cava to an area in the vicinity of the apex of the right ventricle is soft and flexible.

59. A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising:

providing a guide member and a hollow needle having an inside diameter sufficient to pass said guide member therethrough;

providing an introducer sheath used for transvenous placement of a medical device in a patient'"'"'s heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said guide member therethrough;

inserting said needle into a vein of the patient;

passing said guide member through said needle into the vein and into a superior vena cava;

removing said needle;

advancing said guide member across the tricuspid valve to a vicinity of the apex of the right ventricle; and

advancing the introducer sheath over said guide member across the tricuspid valve into the vicinity of the apex of the right ventricle.

60. The method of claim 59 wherein said vein is a cephalic vein.

61. The method of claim 59 wherein said vein is a subclavian vein.

62. The method of claim 59 wherein said guide member is a flexible guidewire.

63. The method of claim 62 further comprising removing said flexible guidewire.

64. The method of claim 63 wherein said flexible guidewire is angled and J-tipped.

65. The method of claim 59 wherein:

said guide member comprises a balloon-tipped catheter;

said method further comprises;

advancing said balloon-tipped catheter in said introducer sheath until a distal end of said balloon-tipped catheter exits the distal end of said introducer sheath in proximity to the tricuspid valve;

inflating a balloon on the distal end of said balloon-tipped catheter;

advancing said balloon-tipped catheter across the tricuspid valve to the apex of the right ventricle; and

advancing said introducer sheath over said balloon-tipped catheter across the tricuspid valve into the vicinity of the apex of the right ventricle and deflating said balloon.

66. The method of claim 59 further comprising:

providing a dilator having a taper at a distal end, a central bore of sufficient size for passing the guide member therethrough, an outside diameter configured for a close fit of said dilator in said introducer sheath, and having a length greater than the length of said introducer sheath;

positioning said dilator fully in said introducer sheath so that the taper at the distal end of said dilator extends past said distal end of said introducer sheath;

sliding said dilator and said introducer sheath together over said guide member through the subclavian vein into the superior vena cava; and

removing said dilator from the superior vena cava.

67. The method of claim 59 further comprising:

providing a permanent pacemaker set having a ventricular pacing lead;

inserting said ventricular pacing lead into said introducer sheath;

advancing said ventricular pacing lead through said introducer sheath to the distal end of said introducer sheath;

removing said introducer sheath;

attaching said ventricular pacing lead to the apex of the right ventricle;

connecting said ventricular pacing lead to said permanent pacemaker set; and

implanting said permanent pacemaker set into the patient.

68. The method of claim 67 wherein:

said introducer sheath further comprises a groove extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be split apart; and

the method further comprising removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and splitting said introducer sheath apart along said groove.

69. The method of claim 67 wherein:

said introducer sheath further comprises a plurality of perforations extending along said introducer sheath to weaken said introducer sheath to allow said introducer sheath to be peeled away; and

the method further comprising, removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and peeling said introducer sheath apart along said perforations.

70. The method of claim 67 further comprising:

providing a slitter for slitting said introducer sheath longitudinally from the proximal end to the distal end upon withdrawal of said introducer sheath from the patient; and

the method further comprising, removing said introducer sheath by withdrawing said introducer sheath over said ventricular pacing lead and slitting said introducer sheath apart with the slitter.

71. The method of claim 59 wherein said needle is inserted into the vein on the patient'"'"'s right side.

72. The method of claim 59 wherein said needle is inserted into the vein on the patient'"'"'s left side.

73. The method of claim 59 further comprising:

making an incision in the skin of the patient; and

inserting the needle through the incision and into the vein of the patient.

74. A method for rapid, atraumatic right ventricular placement of medical devices across a tricuspid valve to an apex of a right ventricle in the heart of a patient comprising:

providing a balloon-tipped catheter and a hollow needle having an inside diameter sufficient to pass said balloon-tipped catheter therethrough;

providing an introducer sheath used for transvenous placement of a medical device in a patient'"'"'s heart, said introducer sheath being of sufficient length to allow a proximal end thereof to be located outwardly from an opening in the skin of the patient over the cephalic vein when a distal end is at an apex of the right ventricle, said introducer sheath having a gradient of stiffness which decreases toward the distal end so as to be sufficiently soft and flexible distally to pass atraumatically through a tricuspid valve and have sufficient strength proximally to allow the introducer sheath to be pushed along the length thereof through a tortuous venous path to the apex of the right ventricle, and having an inside diameter of sufficient size to pass said balloon-tipped catheter therethrough;

inserting said needle into a vein of the patient;

passing said balloon-tipped catheter through said needle into the vein and into a superior vena cava;

removing said needle;

advancing said balloon-tipped catheter in said introducer sheath until a distal end of said balloon-tipped catheter exits the distal end of said introducer sheath in proximity to the tricuspid valve;

inflating a balloon on the distal end of said balloon-tipped catheter;

advancing said balloon-tipped catheter across the tricuspid valve to a vicinity of the apex of the right ventricle;

advancing said introducer sheath over said balloon-tipped catheter across the tricuspid valve into a position adjacent the inflated balloon;

deflating said balloon; and

withdrawing the balloon-tipped catheter.