Catheters, systems and methods for percutaneous in situ arterio-venous bypass

• US 6,544,230 B1
• Filed: 03/31/1999
• Issued: 04/08/2003
• Est. Priority Date: 03/31/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua, Macaulay, Patrick E., Tholfsen, David R., Flaherty, J. Christopher, Whitt, Jason B., Evard, Philip C., Garibotto, John T.
• Primary Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/282,276
• Time in Patent Office: 1,469 Days
• Field of Search: 604/158, 604/159, 604/164, 604/165, 604/171, 604/264, 604/164.01, 604/164.02, 604/164.06, 604/164.09, 604/164.12, 604/165-1-1, 606/12, 606/15
• US Class Current: 604/164.12
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A system of catheter devices and methods for forming channels or passageways between a luminal anatomical structure (e.g., a blood vessel) and a target location (e.g., another blood vessel, an organ, a mass of tissue, etc.) for the purpose of rerouting blood flow or for delivering a substance or instrument, etc. to the target location.

Claims

1. A tissue penetrating catheter device useable to form a single penetration outwardly from the lumen of a blood vessel in which the catheter device is positioned, through the wall of that blood vessel, and to a target location, such that a guidewire may be passed from the lumen of that blood vessel to the target location, said device comprising:

i) a flexible catheter body which is insertable into the blood vessel, said catheter body having a side wall, a proximal end, a distal end and an outlet opening formed in the side wall thereof;

ii) a first lumen through which a separate imaging catheter may be inserted;

iii) a second lumen which extends through said outlet opening;

iv) a tissue penetrating member disposed within said second lumen and advanceable out of said outlet opening and through the wall of the blood vessel and to a target location such that a single penetration is made through the wall of the blood vessel, said tissue penetrating member having a substantially open working lumen extending longitudinally therethrough; and

,

v) an orientation structure positioned on the catheter body, said orientation structure being constructed so as to define an imaging catheter-receiving space therein in alignment with said first lumen and at least one marker member, said marker member being imageable so as to create on an image display received from an imaging catheter positioned within the imaging catheter-receiving space, an indication of the path that will be followed by the tissue penetrating member as the tissue penetrating member is subsequently advanced from the catheter body, wherein the orientation structure comprises a plurality of strut members that extend longitudinally, at circumferentially spaced-apart locations, about said hollow interior space, a first one of said strut members being a) located at a radial position which is aligned with location of the tissue penetration member outlet opening and b) constructed to produce an ultrasound image which is distinguishable form the images produced by the other(s) of said strut members, said first one of said strut members being thereby operative to create, on an image received through an IVUS catheter positioned within hollow interior space.

2. The catheter device of claim 1 wherein a guidewire lumen which

extends longitudinally through said tissue penetration member.

3. The catheter device of claim 1 further comprising a laterally deployable member adjacent the outlet port, said laterally deployable member being initially disposable in a stowed position whereby it is substantially non-protrusive from the catheter and subsequently deployable to a laterally extended position wherein it supports the tissue penetrating member and deters the tissue penetrating member from deviating from the acceptable penetration zone as it is advanced.

4. The catheter device of claim 1 further comprising:

a distal tip member formed on the distal end of said orientation apparatus.

5. The catheter device of claim 4 wherein a lumen extends through the distal tip member such that an imaging catheter may be advanced from the hollow interior space of the orientation structure through the lumen of the distal tip member.

6. The catheter device of claim 1 wherein the tissue penetration member is resilient and has a distal portion which is preformed to a curved configuration, such that when the tissue penetration member is in its retracted position it will conform to the shape of the first lumen of the catheter body and when the tissue penetration member is in its extended position its distal portion will assume the curved configuration to which it was preformed.

7. The catheter device of claim 6 wherein the distal portion of said tissue penetration member is preformed to a curved configuration which has a radius of curvature.

8. The catheter device of claim 1 wherein said tissue penetration member has a lancet type bevel formed on its distal end.

9. The catheter device of claim 6 further comprising:

a rigid, tubular tissue penetration member housing disposed within said second lumen such that, when the tissue penetration member is in its retracted position, the distal tip of the tissue penetration member will be disposed within said tissue penetration member housing.

10. The catheter device of claim 9 wherein said tissue penetration member housing is curved outwardly toward said tissue penetration member outlet aperture.

11. The catheter device of claim 10 wherein the catheter body is slightly bent to conform with the curvature of said tissue penetration member housing.

12. The catheter device of claim 9 wherein a tubular liner is disposed within the tubular tissue penetration member housing.

13. The catheter device of claim 12 wherein said tubular liner is formed of plastic.

14. The catheter device of claim 12 wherein said tubular liner comprises an inner lubricious layer, a middle structural layer and an outer adhesive layer.

15. The catheter device of claim 12 wherein said tubular liner extends out of and beyond either end of the tubular tissue penetration member housing.

16. The catheter device of claim 10 wherein a locator body is connected to said tubular tissue penetration member housing and disposed within said catheter body to stabilize the position and rotational orientation of said tubular tissue penetration member housing.

17. The catheter device of claim 11 wherein surfaces that frictionally engage one another are formed on said tissue penetration member and said catheter body so as to deter rotation of the tissue penetration member relative to the catheter body.

18. The catheter device of claim 17 wherein said frictionally engaged surfaces comprise a key formed on one of said tissue penetration member and said catheter body and a keyway formed on the of said catheter and catheter body, said key being received within said keyway to deter rotation of the tissue penetration member within the catheter body.

19. The catheter device of claim 17 wherein said frictionally engaged surfaces comprise a non-round cross sectional configuration of said tissue penetration member and a non-round cross-sectional configuration of at least a portion of the catheter which surrounds said tissue penetration member, such that the tissue penetration member is deterred from rotating within the catheter body.

20. A system for creation of a penetration tract from the lumen of a coronary vein to the lumen of a coronary artery in a mammalian heart which has a coronary venous sinus, said system comprising a catheter device according to claim 1 in combination with:

a coronary sinus guide catheter which comprises a flexible catheter body having a proximal end, a distal end, a lumen extending longitudinally therethrough, and a curvilinear segment formed near its distal end;

said catheter device being passable through the lumen of the coronary sinus guide catheter and into a coronary vein.

21. The system of claim 20 wherein said coronary sinus guide catheter further comprises:

a hemostatic valve associated with the lumen of the guide catheter, said hemostatic valve being constructed to allow the catheter device to pass therethrough, and said hemostatic valve being operative to;

i) prevent blood from back-flowing out of the coronary sinus guide catheter lumen when the catheter device is not inserted therethrough, and,

ii) form a seal about the catheter device when the catheter device is inserted through the lumen of the guide catheter to prevent blood from back-flowing therethrough.

22. The system of claim 20 further comprising:

an tubular introducer sheath having a tapered distal end and a lumen extending longitudinally therethrough;

said introducer sheath being passable through the lumen of the coronary sinus guide catheter and into the coronary vein; and

,

said catheter device being insertable through the lumen of the introducer sheath and into the coronary vein, distal to the distal end of the introducer sheath.

23. The catheter of claim 1 further comprising a rotational lock apparatus for preventing at least a portion of the tissue penetration member from rotating within the catheter while the tissue penetration member is in its retracted position.

24. A tissue-penetrating catheter device that is positionable in the lumen of a blood vessel and useable to form a penetration tract that extends from the lumen of the blood vessel, through a predetermined acceptable penetration zone and to a target location within the patient'"'"'s body, said catheter device comprising:

i) a flexible catheter body that is insertable into a blood vessel, said catheter body having a proximal end, a distal end, a outlet opening;

ii) a lumen that extends through said outlet opening;

iii) a stabilizer that is configured to deter a tissue penetrating member from deviating from said acceptable penetration zone as it is advanced to said target location; and

,

iv) a single tissue penetrating member disposed within said lumen, said tissue penetrating member being sized and configured such than when sufficiently aimed and stabilized, it will advance out of the outlet port, through the wall of the blood vessel, through the acceptable penetration zone and to said target location;

the tissue penetration member being curved such that rotation of the tissue penetrating member while it is advanced from the catheter will cause the tissue penetration member to deviate from the acceptable penetration zone and said stabilizer comprising a key formed on one of said tissue penetration member and said catheter body and a keyway formed on the other of said catheter and catheter body, said key being received within said keyway to deter rotation of the tissue penetration member within the catheter body.

25. The catheter device of claim 24 wherein the stabilizer is selected form the group of stabilizers consisting of;

engagement members for frictional engagement between the tissue penetrating member and the catheter body;

bushings disposed within the lumen that constrains the tissue penetrating member to prevent side-to-side movement thereof;

a reduced diameter region of the lumen that constrains the tissue penetrating member to prevent side-to-side movement thereof;

at least one magnet that creates a magnetic which prevents side to side movement of the tissue penetrating member; and

,

a member that is laterally deployable from the catheter adjacent the outlet opening to deter side-to-side movement of the tissue-penetrating-member when it is advanced from the catheter.

26. The catheter device of claim 24 wherein the stabilizer comprises:

a rigid, tubular tissue penetration member housing disposed within said second lumen such that, when the tissue penetration member is in its retracted position, the distal tip of the tissue penetration member will be disposed within said tissue penetration member housing.

27. The catheter device of claim 26 wherein said tissue penetration member housing is curved outwardly toward said tissue penetration member outlet aperture.

28. The catheter device of claim 27 wherein the catheter body is slightly bent to conform with the curvature of said tissue penetration member housing.

29. The catheter device of claim 26 wherein a tubular liner is disposed within the tubular tissue penetration member housing.

30. The catheter device of claim 29 wherein said tubular liner is formed of plastic.

31. The catheter device of claim 29 wherein said tubular liner comprises an inner lubricious layer, a middle layer and an outer adhesive layer.

32. The catheter device of claim 29 wherein said tubular liner extends

out of and beyond either end of the tubular tissue penetration member housing.

33. The catheter device of claim 31 wherein a stabilizer body is

connected to said tubular tissue penetration member housing and disposed within said catheter body to stabilize the position and rotational orientation of said tubular tissue penetration member housing

34. The catheter device of claim 24 wherein a guidewire lumen extends longitudinally through said tissue penetration member.

35. The catheter device of claim 24 wherein said stabilizer comprises

a laterally deployable member adjacent the outlet port, said laterally deployable member being initially disposable in a stowed position whereby it is substantially non-protrusive from the catheter and subsequently deployable to a laterally extended position wherein it supports the tissue penetrating member and deters the tissue penetrating member from deviating from the acceptable penetration zone as it is advanced.

36. The catheter device of claim 24 wherein said frictionally engaged surfaces comprise the lateral surface of a tissue penetration member of non-round cross sectional configuration and a corresponding non-round cross-sectional configuration of at least a portion of the catheter which surrounds said tissue penetration member, such that the tissue penetration member is deterred from rotating within the catheter body.

37. The catheter of claim 24 further comprising a rotational lock apparatus for preventing at least a portion of the tissue penetrating member from rotating within the catheter while the tissue penetration member is in its retracted position.

38. The catheter device of claim 37 wherein said rotational lock apparatus comprises a first member formed on the catheter body and a second member formed on the tissue penetration member such that, when the tissue penetration member is in its retracted position, the first and second members will frictionally engage one another to prevent rotation of at least the portion of the tissue penetrating member that is distal to the second member.

39. A tissue-penetrating catheter device that is positionable in the lumen of a blood vessel and useable to form a penetration tract that extends from the lumen of the blood vessel, through the wall of that blood vessel, through a predetermined acceptable penetration zone and to a target location within the patient'"'"'s body, said catheter device comprising:

i) a flexible catheter body that is insertable into a blood vessel, said catheter body having a proximal end, a distal end, a outlet opening;

ii) a lumen that extends through said outlet opening;

iii) a stabilizer that is configured to deter a tissue penetrating member from deviating from said acceptable penetration zone as it is advanced to said target location,

wherein said device consists of a single tissue penetrating member disposed within said lumen, said tissue penetrating member being sized and configured such than when sufficiently aimed and stabilized, it will advance out of the outlet port, through the wall of the blood vessel, through the acceptable penetration zone and to said target location;

said catheter device further comprising a rotational lock apparatus for preventing at least a portion of the tissue penetrating member from rotating within the catheter while the tissue penetration member is in its retracted position, said rotational lock apparatus comprising a first member formed on the catheter body and a second member formed on the tissue penetration member such that, when the tissue penetration member is in its retracted position, the first and second members will frictionally engage one another to prevent rotation of at least the portion of the tissue penetrating member that is distal to the second member.

40. The catheter device of claim 39 wherein a guidewire lumen extends longitudinally through said tissue penetration member.

41. The catheter device of claim 39 wherein the stabilizer is selected form the group of stabilizers consisting of;

engagement members for frictional engagement between the tissue penetrating member and the catheter body;

bushings disposed within the lumen that constrains the tissue penetrating member to prevent side-to-side movement thereof;

a reduced diameter region of the lumen that constrains the tissue penetrating member to prevent side-to-side movement thereof;

at least one magnet that creates a magnetic which prevents side to side movement of the tissue penetrating member; and

,

a member that is laterally deployable from the catheter adjacent the outlet opening to deter side-to-side movement of the tissue-penetrating-member when it is advanced from the catheter.

42. The catheter device of claim 39 wherein the stabilizer comprises:

a rigid, tubular tissue penetration member housing disposed within said second lumen such that, when the tissue penetration member is in its retracted position, the distal tip of the tissue penetration member will be disposed within said tissue penetration member housing.

43. The catheter device of claim 42 wherein said tissue penetration member housing is curved outwardly toward said tissue penetration member outlet aperture.

44. The catheter device of claim 43 wherein the catheter body is slightly bent to conform with the curvature of said tissue penetration member housing.

45. The catheter device of claim 44 wherein a stabilizer body is connected to said tubular tissue penetration member housing and disposed within said catheter body to stabilize the position and rotational orientation of said tubular tissue penetration member housing.

46. The catheter device of claim 42 wherein a tubular liner is disposed within the tubular tissue penetration member housing.

47. The catheter device of claim 46 wherein said tubular liner is formed of plastic.

48. The catheter device of claim 46 wherein said tubular liner comprises an inner lubricious layer, a middle layer and an outer adhesive layer.

49. The catheter device of claim 46 wherein said tubular liner extends out of and beyond either end of the tubular tissue penetration member housing.

50. The catheter device of claim 39 wherein the tissue penetration member is curved such that rotation of the tissue penetrating member while it is advanced from the catheter will cause the tissue penetration member to deviate from the acceptable penetration zone and wherein said stabilizer comprises frictionally engaged surfaces formed on said tissue penetration member and said catheter body to deter rotation of the tissue penetration member relative to the catheter body.

51. The catheter device of claim 50 wherein said frictionally engaged surfaces comprise a key formed on one of said tissue penetration member and said catheter body and a keyway formed on the other of said catheter and catheter body, said key being received within said keyway to deter rotation of the tissue penetration member within the catheter body.

52. The catheter device of claim 50 wherein said frictionally engaged surfaces comprise the lateral surface of a tissue penetration member of non-round cross sectional configuration and a corresponding non-round cross-sectional configuration of at least a portion of the catheter which surrounds said tissue penetration member, such that the tissue penetration member is deterred from rotating within the catheter body.

53. The catheter device of claim 39 wherein said stabilizer comprises a laterally deployable member adjacent the outlet port, said laterally deployable member being initially disposable in a stowed position whereby it is substantially non-protrusive from the catheter and subsequently deployable to a laterally extended position wherein it supports the tissue penetrating member and deters the tissue penetrating member from deviating from the acceptable penetration zone as it is advanced.

54. A tissue penetrating catheter device useable to form a single penetration outwardly from the lumen of a blood vessel in which the catheter device is positioned, through the wall of that blood vessel, and to a target location, such that a guidewire may be passed from the lumen of that blood vessel to the target location, said device comprising:

i) a flexible catheter body which is insertable into the blood vessel, said catheter body having a side wall, a proximal end, a distal end and an outlet opening formed in the side wall thereof;

ii) a first lumen through which a separate imaging catheter may be inserted;

iii) a second lumen which extends through said outlet opening; and

iv) an orientation structure positioned on the catheter body, said orientation structure being constructed so as to define an imaging catheter-receiving space therein in alignment with said first lumen and at least one marker member, said marker member being imageable so as to create on an image display received from an imaging catheter positioned within the imaging catheter-receiving space, an

indication of the path that will be followed by the tissue penetrating member as the

tissue penetrating member is subsequently advanced from the catheter body,

wherein said device consists of a single tissue penetrating member disposed within said second lumen and advanceable out of said outlet opening and through the wall of the blood vessel and to a target location such that a single penetration is made through the wall of the blood vessel, said tissue penetrating member having a substantially open working lumen extending longitudinally therethrough;

said device further comprising a distal tip member formed on the distal end of said orientation apparatus, said lumen extending through the distal tip member such that an imaging catheter may be advanced from the hollow interior space of the orientation structure through the lumen of the distal tip member.

55. The catheter device of claim 54 wherein a guidewire lumen extends longitudinally through said penetration member.

56. The catheter device of claim 54 wherein the orientation structure comprises a plurality of strut members that extend longitudinally, at circumferentially spaced-apart locations, about said hollow interior space, a first one of said strut members being a) located at a radial position which is aligned with location of the tissue penetration member outlet opening and b) constructed to produce an ultrasound image which is distinguishable form the images produced by the other(s) of said strut members, said first one of said strut members being thereby operative to create, on an image received through an IVUS catheter positioned within hollow interior space.

57. A tissue penetrating catheter device useable to form a single penetration outwardly from the lumen of a blood vessel in which the catheter device is positioned, through the wall of that blood vessel, and to a target location, such that a guidewire may be passed from the lumen of that blood vessel to the target location, said device comprising:

i) a flexible catheter body which is insertable into the blood vessel, said catheter body having a side wall, a proximal end, a distal end and an outlet opening formed in the side wall thereof;

ii) a first lumen through which a separate imaging catheter may be inserted;

iii) a second lumen which extends through said outlet opening; and

iv) an orientation structure positioned on the catheter body, said orientation structure being constructed so as to define an imaging catheter-receiving space therein in alignment with said first lumen and at least one marker member, said marker member being imageable so as to create on an image display received from

an imaging catheter positioned within the imaging catheter-receiving space, an

indication of the path that will be followed by the tissue penetrating member as the

tissue penetrating member is subsequently advanced from the catheter body, wherein said device consists of a single tissue penetrating member disposed within said second lumen and advanceable out of said outlet opening and through the wall of the blood vessel and to a target location such that a single penetration is made through the wall of the blood vessel, said tissue penetrating member having a substantially open working lumen extending longitudinally therethrough;

the orientation structure comprising a plurality of strut members that extend longitudinally, at circumferentially spaced-apart locations, about said hollow interior space, a first one of said strut members being a) located at a radial position which is aligned with location of the tissue penetration member outlet opening and b) constructed to produce an ultrasound image which is distinguishable form the images produced by the other(s) of said strut members, said first one of said strut members being thereby operative to create, on an image received through an IVUS catheter positioned within hollow interior space.

58. The catheter device of claim 57 wherein a guidewire lumen extends longitudinally through said penetration member.

59. The catheter device of claim 57 further comprising a distal tip member formed on the distal end of said orientation apparatus.

60. The catheter device of claim 59 wherein a lumen extends through the distal tip member such that an imaging catheter may be advanced from the hollow interior space of the orientation structure through the lumen of the distal tip member.

61. The catheter device of claim 57 wherein the tissue penetration member is resilient and has a distal portion which is preformed to a curved configuration, such that when the tissue penetration member is in its retracted position it will conform to the shape of the first lumen of the catheter body and when the tissue penetration member is in its extended position its distal portion will assume the curved configuration to which it was preformed.

62. The catheter device of claim 61 wherein the distal portion of said tissue penetration member is preformed to a curved configuration which has a radius of curvature.