Device, system and method for intersititial transvascular intervention

• US 5,830,222 A
• Filed: 10/11/1996
• Issued: 11/03/1998
• Est. Priority Date: 10/13/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/730,496
• Time in Patent Office: 753 Days
• Field of Search: 606/1, 606/108, 606/153-156, 606/159, 606/184, 606/185, 600/16-18, 623/1, 623/12, 128/898, 128/899
• US Class Current: 606/159
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 : with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00247 : Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• 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 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00504 : Tissue welding
• CPC Class Codes: A61B 2017/00641 : for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/1107 : for blood vessels
• CPC Class Codes: A61B 2017/1139 : Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/22077 : with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3925 : ultrasonic
• CPC Class Codes: A61B 2090/3929 : Active markers
• CPC Class Codes: A61B 2090/3958 : emitting a signal
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/018 : Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector

Abstract

Method and apparatus for utilizing the vascular system as a conduit to reach other vascular and extravascular locations within the body. Included are methods for revascularization wherein the extravascular passageways are formed to permit blood flow between vascular locations. Also included are methods for performing transvascular interstitial surgery (TVIS) wherein extravascular passageways are formed from a blood vessel to another vascular or non-vascular intracorporeal location. Also disclosed are devices usable for forming extravascular passageways in accordance with the invention, or for modifying, valving, maintaining or closing such passageways.

Claims

1. A method for effecting revascularization of a portion of the cardiovascular system of a mammalian patient, said method comprising the steps of:

(A). providing a pliable catheter which has a tissue penetrating element passable therefrom;

(B). inserting said catheter into the vasculature and advancing said catheter to a first location within the cardiovascular system of the patient;

(C). passing the tissue penetrating element from the catheter to form a first interstitial passageway from said first location to a second location within the cardiovascular system of the patient, and through any tissue located between said first and second locations, said interstitial passageway thereafter functioning as a conduit to carry blood, in at least one direction, between said first and second locations.

(D). placing the catheter at a third location within the cardiovascular system of the patient; and

,

(E). passing the tissue penetrating element from the catheter, a second time, to form a second interstitial passageway which extends from the third location within the cardiovascular system of the patient to a forth location within the cardiovascular system of the patient, and through any tissue located between said third and fourth locations, said second interstitial passageway thereafter functioning as a conduit to carry blood, in at least one direction, between said third and forth locations.

2. The method of claim 1 wherein one of said first and second locations is located within a portion of the cardiovascular system which contains arterial blood, and the other of said first and second locations is a location within a coronary blood vessel, such that the first passageway created in step C functions to carry arterial blood into the coronary blood vessel.

3. The method of claim 1 further comprising the step of:

(F). blocking blood flow at at least one location within the cardiovascular system to divert blood flow through at least one of said first and second passageways.

4. The method of claim 1 further comprising the step of:

(F). applying energy to tissue surrounding at least one of said first and second passageways to fuse tissue which surrounds that passageway.

5. The method of claim 1 further comprising the step of:

(F). placing at least one staple in tissue which surrounds at least one of said first and second passageways to maintain the relative positions of the particular ones of said first, second, third and forth locations between which that passageway extends.

6. The method of claim 1 further comprising the step of:

(F). placing at least one connector apparatus within at least one of said first and second passageways to maintain the relative positions of the particular ones of said first, second, third and fourth locations between which that passageway extends.

7. The method of claim 1 wherein step E further comprises:

enlarging at least one of said first and second passageways.

8. The method of claim 1 wherein step E further comprises:

placing a stent within at least one of said first and second interstitial passageways to control the dimensions of that passageway.

9. The method of claim 1 wherein step E further comprises:

placing a one-way valving stent within at least one of said first and second interstitial passageways to control the dimensions of that passageway and to prevent blood from flowing in one direction through that passageway.

10. The method of claim 1 further comprising the step of:

(G). blocking blood flow at a first location within the cardiovascular system to divert blood flow through the first interstitial passageway.

11. The method of claim 10 further comprising the step of:

(H). blocking blood flow at a second location within the cardiovascular system to divert blood flow through said second passageway.

12. The method of claim 1 wherein the method is carried out to bypass an obstruction in a coronary artery which lies adjacent a coronary vein, and wherein:

said first location is within said coronary artery upstream of the obstruction and said second location is within said coronary vein, such that arterial blood passes through said passageway and into said coronary vein, said arterial blood thereafter flowing through a portion of said coronary vein in a direction opposite normal venous flow; and

,

said third location is within the portion of the coronary vein through which said arterial blood flows and said fourth location is within a coronary artery, said arterial blood flowing from the portion of the coronary vein, through the second interstitial passageway, and into said coronary artery, to thereby perfuse the myocardium through said coronary artery.

13. The method of claim 12 wherein:

said fourth location is located downstream of the obstruction in the same obstructed coronary artery in which the first location is located.

14. The method of claim 1 wherein the catheter provided in step A further comprises an orientation apparatus, and wherein the method further comprises:

utilizing said orientation apparatus prior to step C, to orient the catheter such that the tissue penetrating element is aimed at the second location.

15. The method of claim 1 wherein the catheter provided in step A further comprises an orientation apparatus, and wherein the method further comprises:

utilizing said orientation apparatus prior to step E, to orient the catheter such that the tissue penetrating element is aimed at the fourth location.

16. The method claim 1 wherein the method further comprises:

D. placing a stent, which is longer than said interstitial passageway, within the interstitial passageway and extending into the cardiovascular system of the patient adjacent at least one of said first and second locations.

17. The method of claim 1 wherein the method further comprises:

F. placing a stent within at least one of said first and second interstitial passageways said stent being longer than the passageway in which it is placed such that said stent extends out of that passageway and into an adjacent portion of the cardiovascular system of the patient.

18. The method of claim 1 further comprising the step of:

(G) passing a guidewire through at least one of said first and second passageways.

19. The method of claim 1 wherein the tissue penetrating element which is passed from the passageway-forming catheter to form said first and second interstitial passageways comprises an elongate member having a guidewire-passage lumen extending therethrough, and wherein said method further comprises:

(G) passing a guidewire through said guidewire lumen to cause said guidewire to extend through at least one of said first and second passageways.

20. The method of claim 19 further comprising the step of:

(H) retracting the tissue penetrating element into the passageway-forming catheter while allowing the guidewire to remain within at least one of said first and second interstitial passageways.

21. A method for effecting revascularization of the heart of a mammalian patient, said method comprising the steps of:

(A). transluminally forming a first opening in an arterial blood-containing portion of the patient'"'"'s cardiovascular system;

(B). transluminally forming a second opening in a venous blood-containing portion of the patient'"'"'s coronary circulation; and

,

(C). causing blood to flow between said first and second openings such that arterial blood which passes through said second opening will subsequently flow through at least one coronary vein, in a direction opposite normal venous flow, to thereby perfuse the myocardium.

22. The method of claim 21 wherein step A is carried out by advancing a catheter which has a tissue-penetrating element passable therefrom, into the circulatory system of the heart, and therafter using said tissue penetrating element to form said first opening.

23. The method of claim 21 wherein step B is carried out by transluminally advancing a catheter which has a tissue-penetrating element passable therefrom, into the circulatory system of the heart, and thereafter using said tissue penetrating element to form said second opening.

24. The method of claim 21 wherein steps A and B are carried out by advancing a catheter which has a tissue-penetrating element passable therefrom, into the circulatory system of the heart, and thereafter using said tissue penetrating element to form said first and second openings.

25. The method of claim 21 wherein step C of the method comprises forming an interstitial tunnel between said first and second openings.

26. The method of claim 25 wherein steps A and B are carried out, and said interstitial tunnel is formed, by advancing a catheter which has a tissue-penetrating element passable therefrom, into the circulatory system of the heart, and thereafter using said tissue penetrating element to form said first and second openings and said interstitial tunnel.

27. The method of claim 21 further comprising the steps of:

(D). transluminally forming a third opening in a coronary vein through which said arterial blood flows;

(E). transluminally forming a fourth opening at a forth location within the circulatory system of the heart; and

,

(F). causing arterial blood to flow from said third opening and through said fourth opening to thereby perfuse the myocardium through the circulatory system of the heart.

28. The method of claim 27 wherein said fourth opening is formed in a coronary artery.

29. The method of claim 28 wherein there exists an obstruction within the coronary artery in which the fourth opening is formed, and wherein said fourth opening is formed downstream of the obstruction.

30. The method of claim 27 wherein step F comprises forming a second interstitial tunnel between said third and forth openings.

31. The method of claim 30 wherein step F further comprises:

enlarging the interstitial tunnel created between said third and forth openings.

32. The method of claim 30 wherein step F further comprises:

placing a stent within the interstitial tunnel to control the dimensions of the interstitial tunnel.

33. The method of claim 30 wherein step F further comprises:

placing a one-way valving stent within the interstitial tunnel to control the dimensions of the interstitial tunnel and to prevent blood from flowing in one direction through the interstitial tunnel.

34. The method of claim 21 further comprising the step of:

(D). blocking blood flow at a location within the circulatory system of the heart to cause blood to flow between said first and second openings.

35. The method of claim 25 further comprising the step of:

(D). applying energy to tissue surrounding said interstitial tunnel to fuse the tissue surrounding said interstitial tunnel.

36. The method of claim 25 further comprising the step of:

(D). placing at least one staple in the heart to maintain the positions of said first and second openings relative to one another.

37. The method of claim 21 further comprising the step of:

(D). placing at least one connector apparatus between said first and second openings to maintain the positions of said first and second openings relative to one another.

38. The method of claim 27 wherein step F comprises forming a second interstitial tunnel between the third and forth openings.

39. The method of claim 37 wherein step F further comprises:

enlarging the second second interstitial tunnel.

40. The method of claim 37 wherein step F further comprises:

placing a stent within the second interstitial tunnel to control the dimensions of the second passageway.

41. The method of claim 37 wherein step F further comprises:

placing a one-way valving stent within the second interstitial tunnel to control the dimensions of the second interstitial tunnel and to prevent blood from flowing in one direction through the second interstitial tunnel.

42. The method of claim 27 further comprising the step of:

(G). blocking blood flow at a location within the circulatory system of the heart to cause blood to flow between said third and forth openings.

43. The method of claim 37 further comprising the step of:

(G). applying energy to tissue surrounding said second interstitial tunnel to fuse the tissue surrounding said second interstitial tunnel.

44. The method of claim 27 further comprising the step of:

(G). placing at least one staple in the heart to maintain the positions of said third and forth openings relative to one another.

45. The method of claim 27 further comprising the step of:

(G). placing at least one connector apparatus between said third and forth openings to maintain the positions of said third and fourth openings relative to one another.

46. The method of claim 22 wherein the catheter used in step A further comprises an orientation apparatus, and wherein the method further comprises:

utilizing said orientation apparatus prior to step a, to orient the catheter such that the tissue penetrating element is aimed at the first location.

47. The method of claim 23 wherein the catheter used in step B further comprises an orientation apparatus, and wherein the method further comprises:

utilizing said orientation apparatus prior to step B, to orient the catheter such that the tissue penetrating element is aimed at the second location.

48. The method of claim 24 wherein the catheter used in steps A and B further comprises an orientation apparatus, and wherein the method further comprises:

utilizing said orientation apparatus prior to steps A and B, to orient the catheter such that the tissue penetrating element will form said first opening at said first location and said second opening at said second location.

49. The method of claim 27 wherein the third opening is formed by a catheter which has a tissue penetrating element passable therefrom and an orientation apparatus for determining the orientation of the catheter within the body, and wherein the method further comprises:

utilizing said orientation apparatus prior to step D, to orient the catheter such that the tissue penetrating element will form said third opening at a predetermined location in said coronary vein.

50. The method of claim 27 wherein the third opening is formed by a catheter which has a tissue penetrating element passable therefrom and an orientation apparatus for determining the orientation of the catheter within the body, and wherein the method further comprises:

utilizing said orientation apparatus prior to step E, to orient the catheter such that the tissue penetrating element will form said fourth opening at a predetermined location in the circulatory system of the heart.

51. A method for effecting revascularization of a portion of the cardiovascular system of a mammalian patient, said method comprising the steps of:

(A). providing a pliable catheter which has a tissue penetrating element passable therefrom and an orientation apparatus;

(B). inserting said catheter into the vasculature and advancing said catheter to a first location within the cardiovascular system of the patient; and

,

(C). utilizing said orientation apparatus to orient the catheter such that the tissue penetrating element is aimed at the second location,

(D). passing the tissue penetrating element from the catheter to form an interstitial passageway from an first location to the second location within the cardiovascular system of the patient and through any tissue located between said first and second locations, said interstitial passageway thereafter functioning as a conduit to carry blood, in at least one direction, between said first and second locations.

52. The method of claim 51 wherein one of said first and second locations is a location within the cardiovascular system which contains arterial blood, and the other of said first and second locations is a location within a coronary blood vessel, and wherein the passageway created in step C functions to carry arterial blood into the coronary blood vessel.

53. The method of claim 51 further comprising the steps of:

(E). placing the catheter at a third location within the cardiovascular system of the patient; and

,

(F). passing the tissue penetrating element from the catheter, a second time, to form a second interstitial passageway which extends from the third location within the cardiovascular system of the patient, through adjacent tissue, to a forth location within the cardiovascular system of the patient, said second interstitial passageway thereafter functioning as a conduit to carry blood, in at least one direction, between said third and forth locations.

54. The method of claim 51 wherein step D further comprises:

enlarging the passageway created by the passage of the tissue penetrating element from the catheter.

55. The method of claim 51 wherein step D further comprises:

placing a stent within the passageway to control the dimensions of the passageway.

56. The method of claim 51 wherein step D further comprises:

placing a one-way valving stent within the passageway to control the dimensions of the passageway and to prevent blood from flowing in one direction through the passageway.

57. The method of claim 51 further comprising the step of:

(E). blocking blood flow at a location within the cardiovascular system to divert blood flow through said passageway.

58. The method of claim 51 further comprising the step of:

(E). applying energy to tissue surrounding said passageway to fuse the tissue surrounding said passageway.

59. The method of claim 51 further comprising the step of:

(E). placing at least one staple in tissue surrounding said passageway to maintain the positions of said first and second locations relative to one another.

60. The method of claim 51 further comprising the step of:

(E). placing at least one connector apparatus within the passageway to maintain the positions of said first and second locations relative to one another.

61. The method of claim 53 wherein step F further comprises:

enlarging the second interstitial passageway created by the passage of the tissue penetrating element from the catheter a second time.

62. The method of claim 53 wherein step F further comprises:

placing a stent within the second interstitial passageway to control the dimensions of the second passageway.

63. The method of claim 52 wherein step F further comprises:

placing a one-way valving stent within the second interstitial passageway to control the dimensions of the second interstitial passageway and to prevent blood from flowing in one direction through the passageway.

64. The method of claim 53 further comprising the step of:

(G). blocking blood flow at a location within the cardiovascular system to divert blood flow through said second interstitial passageway.

65. The method of claim 53 further comprising the step of:

(G). applying energy to tissue surrounding said second interstitial passageway to fuse the tissue surrounding said second passageway.

66. The method of claim 53 further comprising the step of:

(G). placing at least one staple in tissue surrounding said second interstitial passageway to maintain the positions of said third and forth locations relative to one another.

67. The method of claim 53 further comprising the step of:

(G). placing at least one connector apparatus within the second interstitial passageway to maintain the positions of said third and forth locations relative to one another.

68. The method of claim 51 wherein the method is carried out to bypass an obstruction in a coronary artery which lies adjacent to a coronary vein, and wherein:

said first location is within said coronary artery upstream of the obstruction and said second location is within said coronary vein, such that arterial blood from said coronary artery passes through said passageway and into said coronary vein, said arterial blood thereafter flowing through said coronary vein in a direction opposite normal venous flow, to perfuse the myocardium through said coronary vein.

69. The method of claim 53 wherein the method is carried out to bypass an obstruction in a coronary artery which lies adjacent a coronary vein, and wherein:

said first location is within said coronary artery upstream of the obstruction and said second location is within said coronary vein, such that arterial blood passes through said passageway and into said coronary vein, said arterial blood thereafter flowing through a portion of said coronary vein in a direction opposite normal venous flow; and

,

said third location is within the portion of the coronary vein through which said arterial blood flows and said fourth location is within a coronary artery, said arterial blood flowing from the portion of the coronary vein, through the second interstitial passageway, and into said coronary artery, to thereby perfuse the myocardium through said coronary artery.

70. The method of claim 69 wherein:

said fourth location is located downstream of the obstruction in the same obstructed coronary artery in which the first location is located.

71. The method of claim 51 further comprising the step of:

(E) passing a guidewire through said passageway.

72. The method of claim 51 wherein the tissue penetrating element of the passageway-forming catheter provided in Step A comprises an elongate member which has a guidewire-passage lumen extending therethrough, and wherein said method further comprises:

(E) passing a guidewire through said guidewire lumen to cause said guidewire to extend through said passageway.

73. The method of claim 72 further comprising the step of:

(F) retracting the tissue penetrating element into the passageway-forming catheter while allowing the guidewire to remain within at least one of said first and second interstitial passageways.

74. A method for rerouting bloodflow in coronary or peripheral blood vessels of a mammalian body, without transecting any of said blood vessels, said method comprising the steps of:

(A) forming a first opening in the wall of a blood vessel;

(B) forming a second opening in the wall of a blood vessel; and

,

(C) forming an interstitial passageway through any tissue located between said first and second openings such that blood will flow out of said first opening and into said second opening.

75. The method of claim 74 wherein the first opening is formed in the wall of a first blood vessel and the second opening is formed in the wall of a second blood vessel.

76. The method of claim 74 wherein the first and second openings are formed at different locations on the same blood vessel.

77. The method of claim 74 wherein Steps A, B and C are performed by transluminally advancing a passageway forming catheter into one of said coronary or peripheral blood vessels, and subsequently passing a tissue penetrating element from the passageway forming catheter such that said tissue penetrating element will form said first and second openings and said interstitial passageway through any tissue located between said first and second openings.

78. The method of claim 77 further comprising the step of:

(D) enlarging the passageway created by the passage of the tissue penetrating element from the passageway forming catheter.

79. The method of claim 78 wherein Step D comprises:

advancing a guidewire through the first and second openings and any interstitial passageway created between said first and second openings by the passage of the tissue penetrating element from the passageway forming catheter; and

,

advancing a passageway enlarging apparatus over said guidewire to enlarge said first and second openings passageway.

80. The method of claim 74 further comprising the step of:

(D) placing a stent within said first and second openings, and within any interstitial passageway formed between said first and second openings.

81. The method of claim 74 further comprising the step of:

(D) placing a connector apparatus within said first and second openings to form a connection between said first and second openings.

82. The method of claim 74 further comprising the step of:

(D) At least partially blocking flow through one of said blood vessels so as to reroute blood out of said first opening, through any interstitial passageway formed between any tissue located between said first and second openings, and into said second opening.

83. The method of claim 74 wherein said blood vessels are coronary blood vessels, and said method is carried out for the purpose of improving the flow of blood to a region of the heart which is deprived of blood flow due to an obstruction in a coronary artery.

84. The method of claim 74 wherein said blood vessels are peripheral blood vessels, and said method is carried out for the purpose of improving the flow of blood to a limb of the patients body which is deprived of blood flow due to an obstruction in a peripheral artery.