Catheters and related devices for forming passageways between blood vessels or other anatomical structures

• US 6,302,875 B1
• Filed: 04/11/1997
• Issued: 10/16/2001
• Est. Priority Date: 10/11/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Tumas, Margaret W., Machold, Timothy R., Flaherty, J. Christopher, Makower, Joshua, Evard, Philip Christopher, Whitt, Jason Brian, Macaulay, Patrick Edward, Garibotto, John Thomas, Selfridge, Alan Robert
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/837,294
• Time in Patent Office: 1,649 Days
• Field of Search: 623/1, 604/528, 606/159, 606/167, 606/41, 606/42, 606/48, 606/45, 128/660.07, 128/660.08, 128/660.03, 607/101, 607/102
• US Class Current: 604/528
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12136 Balloons
• 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 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 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 18/1477 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 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 2017/1107 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 2017/22067 : Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 : Centering
• CPC Class Codes: A61B 2017/22069 : Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22072 : with an instrument channel, e.g. for replacing one instrument by the other
• 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 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• 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 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 8/4488 : the transducer being a phased array
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/009 : the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0141 : having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

Claims

1. A catherer device comprising:

i) an elongate catherer body having a proximal end and a distal end;

ii) a tissue-penetrating element which is passable out of the elongate catherer body so as to pass through the wall of a luminal anatomical structure in which the catherer body is positioned and on a known trajectory to a target location;

iii) an imaging element which is useable to image the target location, and,

iv) an imageable marker positioned on said catherer body to produce a marker image, said marker image being in a known positional relationship to the trajectory of the tissue penetrating element, such that when the catherer is positioned and oriented so that the marker image is in a a desired position relative to said target location, subsequent passage of said tissue penetrating element from the catherer body will result in penetration through the wall of said luminal anatomical structure and to said target location.

2. The catheter of claim 1 wherein said marker comprises:

a U-shaped member mounted on said catheter.

3. The catheter of claim 1 wherein said marker comprises:

an elongate, generally rectangular member mounted on said catheter.

4. The catheter of claim 1 wherein said marker comprises:

at least one elongate wire mounted on said catheter.

5. The catheter of claim 1 wherein said marker comprises:

a region extending at least partially around the circumference of the distal end of said elongate catheter body, said region having anisotropic properties such that the imaging element may be used to align a specific region with the target location.

6. The catheter of claim 1 wherein said marker comprises:

a plurality of elongate members in fixed positional relationship to each other, at least one of said elongate members being aligned with said first location.

7. The catheter of claim 6 wherein the at least one of said elongate members that is aligned with said first location is distinguishable from the others of said elongate members, on the image produced by the imaging element.

8. The catheter of claim 7 wherein said at least one elongate member is distinguishable from the others of said elongate members, on the image produced by the imaging element, due to its placement relative to the others of said elongate members.

9. The catheter of claim 7 wherein said at least one elongate member is distinguishable from the others of said elongate members, on the image produced by the imaging element, due to anisotropic properties of said at least one elongate member.

10. The catheter of claim 7 wherein said at least one elongate member is distinguishable from the others of said elongate members, on the image produced by the imaging element, due to its size relative to the size of the others of said elongate members.

11. The catheter of claim 7 wherein said at least one elongate member is distinguishable from the others of said elongate members, on the image produced by the imaging element, due to its shape relative to the shapes of the others of said elongate members.

12. The catheter of claim 1 wherein said marker comprises an arcuate member which is attached to and extends distally from the catheter body, said arcuate member being disposed in a plane which is substantially perpendicular to the path of the tissue-penetrating element.

13. The catheter of claim 1 wherein said marker comprises a tripod member mounted on the distal end of the catheter, said tripod member having first, second, and third legs, wherein at least one of said legs is in alignment with the path of the tissue penetrating element.

14. The catheter of claim 1 wherein said marker is radiographically visible.

15. The catheter of claim 1 wherein the imaging element comprises

an imaging lumen configured to receive a second imaging element such that said second imaging element may be used to image said marker and said target location.

16. The catheter of claim 15 wherein said imaging lumen is configured to receive a second imaging element which comprises an intravascular ultrasound catheter.

17. A system comprising the catheter device of claim 16 in combination with an imaging catheter which is insertable into said imaging lumen.

18. The system of claim 17 wherein said imaging catheter is an intravascular ultrasound catheter.

19. The catheter of claim 15 wherein said imaging lumen extends longitudinally through the catheter and opens through an outlet aperture in the distal end of the catheter, and wherein said second imaging element is advanceable through said imaging lumen such that it protrudes out of and extends beyond the distal end of the catheter.

20. The catheter of claim 15 wherein said imaging lumen extends longitudinally through said catheter and wherein an imaging window is formed in said catheter such that said second imaging element may be advanced through said imaging lumen and utilized to obtain an image of said marker and said target location, through said imaging window.

21. The catheter device of claim 1 wherein the imaging element comprises a phased array transducer.

22. The catheter device of claim 21 wherein said phased array transducer comprises a plurality of individual signal emitting crystals arranged in a circumferential array.

23. The catheter device of claim 1 wherein the imaging element comprises an ultrasound transducer.

24. The catheter of claim 1 wherein said catheter body comprises:

a proximal catheter body portion having a distal end; and

,

a distal tip portion mounted on the distal end of the proximal catheter body portion.

25. The catheter device of claim 24 wherein said distal tip portion is softer than said proximal catheter body portion.

26. The catheter device of claim 24 wherein said distal tip portion includes a lumen which extends at least partially longitudinally therethrough.

27. The catheter device of claim 26 wherein said lumen extends fully through the distal tip portion.

28. The catheter device of claim 24 wherein said distal tip portion is attached to said proximal catheter body portion by at least one elongate member which extends between said proximal catheter body portion and said distal tip portion.

29. The catheter device of claim 28 wherein said at least one elongate member comprises a strut.

30. The catheter device of claim 28 wherein said at least one elongate member comprises a wire.

31. The catheter device of claim 30 wherein said elongate member traverses said imaging window such that said elongate member and said target location may be concurrently viewed, through said imaging window, by said imaging element.

32. The catheter of claim 31 wherein said at least one elongate member protrudes beyond the distal end of said distal tip portion.

33. The catheter device of claim 1 wherein said marker is a signal-emitting component which emits a signal that is detectable by said imaging element.

34. The catheter device of claim 33 wherein said energy-emitting component is a piezoelectric crystal.

35. The catheter device of claim 1 wherein the target location is at a known distance from said first location on said catheter body, and wherein said marker further comprises:

a plurality of distance-correlated markings, each said distance-correlated markings being correlated to a specific distance from said first location on said catheter body such that said imaging element is thereby useable in conjunction with said distance-correlated markings to cause the catheter body to be positioned within said luminal anatomical structure such that a selected one of said distance-correlated markings is aligned with said target location, thereby indicating that said tissue penetrating element will pass to said target location and not beyond said target location.

36. The catheter device of claim 1 wherein said tissue-penetrating element comprises a resilient, pre-bent member having a sharpened distal tip.

37. The catheter device of claim 1 wherein said tissue-penetrating element comprises an elongate member which is operative to emit energy.

38. The catheter device of claim 37 wherein said tissue-penetrating element comprises a flow of energy passable out of said first location in said catheter body.

39. The catheter device of claim 38 wherein said flow of energy is a beam of laser light.

40. The catheter device of claim 1 wherein said catheter body comprises an elongate flexible catheter body having a distal end, at least one lumen extending longitudinally through the catheter body, and a distal end opening through which said lumen opens at the distal end of said catheter body, a portion of said catheter body immediately adjacent the distal end thereof being alternately moveable between:

i) a straight configuration; and

,

ii) a curved configuration.

41. The catheter device of claim 40 wherein said marker is positioned at a known location on said catheter and is imagable by said imaging element, said marker being useable to facilitate positioning and rotational orientation of said catheter within said luminal anatomical structure such that, when the distal portion of the catheter is moved to its curved configuration, the distal opening of the catheter will be aimed such that when the tissue penetrating element is passed out of said distal opening it will pass to said target location.

42. A system comprising a catheter device according to claim 1 having a lumen which extends through said catheter body, in combination with:

a passageway modifying apparatus which is passable through said at least one lumen of said catheter and out of said distal opening, said passageway modifying apparatus being useable to modify a passageway which has been initially formed by said tissue-penetrating element.

43. The system of claim 42 wherein said passageway modifying apparatus is selected from the group consisting of:

an apparatus for closing said passageway;

an apparatus for stenting said passageway;

an apparatus for enlarging said passageway;

an apparatus for cauterizing said passageway;

an apparatus for placing a channel connector within said passageway;

an apparatus for blocking the lumen of an anatomical conduit on either side of said passageway to effect flow through said passageway.

44. The catheter device of claim 1 wherein the marker is formed of material which is reflective of energy which is received by the imaging element for the purpose of forming the image.

45. The catheter of claim 1 wherein the marker is formed of material which is partially internally reflective of energy which is received by the imaging element for the purpose of forming the image.

46. The catheter of claim 1 wherein the marker is formed of material which is absorptive of energy which is received by the imaging element for the purpose of forming the image.

64. The catheter of claim 1 wherein said marker is visible by ultrasound.

47. A catheter device useable to penetrate through the wall of an anatomical structure in which the catheter is positioned and to a target location outside of that anatomical structure, said device comprising:

an elongate catheter body having an outlet aperture formed therein;

a tissue penetrating element passable out of said outlet aperture;

imaging apparatus having an orientation element positioned in a fixed relationship with said outlet aperture such that when the orientation element is correlated with the target location, the tissue penetrating element will be aimed to penetrate through the wall of the anatomical structure and to said target location.

48. The catheter device of claim 47 wherein said imaging apparatus is a phased array transducer.

49. The catheter device of claim 48 wherein said phased array transducer comprises a plurality of individual signal emitting crystals arranged in a circumferential array.

50. The catheter device of claim 49 wherein at least one of said crystals is aligned with said outlet aperture and wherein said orientation element comprises a signal modifier which is operative to modify the signal received from those crystal(s) which is/are aligned with said outlet aperture.

51. The catheter device of claim 50 wherein said signal modifier is operative to amplify the signal received from the crystal(s) which is/are aligned with said outlet aperture.

52. The catheter device of claim 50 wherein said signal modifier is operative to negate the signal received from the crystal(s) which is/are aligned with said outlet aperture.

53. The catheter device of claim 47 wherein an imaging lumen extends longitudinally through said catheter body, and wherein said imaging apparatus comprises an imaging apparatus which is advanceable through said imaging catheter lumen.

54. The catheter device of claim 53 wherein said imaging lumen extends longitudinally through the catheter and opens through an outlet aperture in the distal end of the catheter, and wherein said imaging apparatus is advanceable through said lumen such that the imaging apparatus protrudes out of and extends beyond the distal end of the catheter.

55. The catheter of claim 53 wherein said imaging lumen extends longitudinally through said catheter and wherein an imaging window is formed on said catheter such that the imaging apparatus may be advanced through said imaging lumen and utilized to obtain an image of said target location, through said imaging window.

56. The catheter of claim 53 wherein said imaging lumen and said imaging apparatus are formed such that when said imaging apparatus is advanced through said imaging lumen said imaging apparatus frictionally engages said imaging lumen at a fixed circumferential location therein, said fixed circumferential location being position such that when the imaging apparatus is engaged, the orientation element of said imaging apparatus is in alignment with said outlet aperture on the catheter.

57. The catheter of claim 47 wherein said imaging apparatus is fixed to said catheter body.

58. The catheter of claim 47 wherein said imaging apparatus is within said catheter body.

59. The catheter of claim 47 wherein an imaging window is formed in said catheter body and said imaging apparatus is operative to image through said imaging window.

60. The catheter device of claim 59 wherein said imaging window is a opening in said catheter body.

61. The catheter of claim 59 wherein said window is a region of said catheter body which permits the imaging apparatus to image through said window.

62. The catheter of claim 59 wherein said window is surrounded by a portion of said catheter body and wherein at least the portion of said catheter body which surrounds said window comprises matter which deters the imaging apparatus from receiving an image therethrough.

63. The catheter device of claim 49 wherein at least one of said crystals is fixedly aligned with said outlet aperture.

65. A catheter device comprising:

i) an elongate catheter body comprising an elongate proximal catheter body portion that has a diastal end, and a distal tip portion located on the distal end of the proximal catheter body portion;

ii) at least one member that extends between the distal end of the proximal body portion and the distal tip portion;

iii) a tissue-penetrating element which is passable out of a first location on the elongate catheter body so as to pass through the wall of a luminal anatomical structure in which the catheter body is positioned to a target anatamical location;

iv) an imaging element that is useable to image the target anatomical location and the elongate member;

v) an imaging window formed in said catheter body; and

vi) the elongate member being positioned on said catheter body relative to said imaging element and said first location, such that the imaging element may be utilized to obtain an image of said marker and said target anatomical location through said imaging window and when the catheter is positioned such that the image of the elongate member is in alignment with the image of the target location, the tissue penetrating element will penetrate through the wall of said luminal anatomical structure and to said target anatomical location.

66. The catheter device of claim 65 wherein said elongate member traverses said imaging window such that said elongate member and said target location may be concurrently viewed, through said imaging window, by said imaging element.

67. The catheter device of claim 66 wherein said at least one elongate member protrudes beyond the distal end of said distal tip portion.

68. A catheter device comprising:

i) an elongate catheter body having a proximal end and a distal end;

ii) a tissue-penetrating element which is passable out of a first location on the elongate catheter body so as to pass through the wall of a luminal anatomical structure in which the catheter body is positioned to a target location;

iii) an imaging element which is useable to image the target location, and,

iv) a marker positioned on said catheter body relative to said imaging element and said first location, such that when the catheter is positioned with said marker in alignment with said target location, said tissue penetrating element will penetrate through the wall of said luminal anatomical structure and to said target location, wherein said marker comprises a notch formed within said catheter.

69. A catheter device comprising:

i) an elongate catheter body having a proximal end and a distal end;

ii) a tissue-penetrating element which is passable out of a first location on the elongate catheter body so as to pass through the wall of a luminal anatomical structure in which the catheter body is positioned to a target location;

iii) an imaging element which is useable to image the target location, and,

iv) a marker positioned on said catheter body relative to said imaging element and said first location, such that when the catheter is positioned with said marker in alignment with said target location, said tissue penetrating element will penetrate through the wall of said luminal anatomical structure and to said target location, wherein said marker comprises;

1) an opening formed within said catheter body, said imaging element being located so as to receive an image of target locations located within a line of sight through said opening; and

,

2) at least one strut member which extends into said line of sight such that said at least one strut member is useable for aiming of the tissue penetrating element at said target location.

70. The catheter of claim 69 wherein said at least one strut member comprises an elongate view.

71. The catheter of claim 69 wherein said opening comprises a region which is cut away from said catheter body such that there is defined a proximal catheter body portion proximal to said opening, and a distal catheter body portion distal to said opening.

72. The catheter of claim 71 wherein said imaging element comprises a) an imaging catheter lumen which extends longitudinally through said catheter body, and b) an imaging catheter which is advanceable through said imaging catheter lumen to image said at least one strut member as well as other structures that are located within the line of signt through said opening.