Device for interstitial transvascular intervention and revascularization

• US 6,159,225 A
• Filed: 10/27/1998
• Issued: 12/12/2000
• 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): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/181,013
• Time in Patent Office: 777 Days
• Field of Search: 606/1, 606/7, 606/16, 606/17, 606/108, 606/184, 606/185, 604/164, 604/174, 600/424, 600/433-435, 600/466, 600/467
• US Class Current: 606/155
• 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 catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating member defining a guidewire lumen therein, the tissue penetrating member being passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element which comprises (i) an imaging apparatus and (ii) an imageable marker, at least one of said imaging apparatus and imageable marker being located on the distal portion of said catheter body;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vasculature of the patient such that, when the tissue penetrating member is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

2. The device of claim 1 wherein the orientation element is useable by the operator to determine the longitudinal position of the catheter within the vasculature.

3. The device of claim 1 wherein the orientation element is useable by the operator to determine the rotational orientation of the catheter within the vasculature.

4. The device of claim 1 wherein the orientation element is useable by the operator to determine the longitudinal position and rotational orientation of the catheter within the vasculature.

5. The catheter device of claim 1 wherein said orientation element comprises:

an imageable marker located on the catheter body; and

,

an imaging apparatus located other than on said catheter body for imaging said imageable marker.

6. The catheter device of claim 5 wherein said marker is a passive marker imageable by said imaging apparatus.

7. The catheter device of claim 6 wherein said passive marker is a radiopaque material and wherein said imaging apparatus is a radiographic apparatus.

8. The catheter device of claim 6 wherein said passive marker is a ferromagnetic material and wherein said imaging apparatus is a magnetic apparatus.

9. The catheter device of claim 5 wherein said marker is a active marker imageable by said imaging apparatus.

10. The catheter device of claim 5 wherein said imaging apparatus is radiographic.

11. The catheter device of claim 5 wherein said imaging apparatus is flouroscopic.

12. The catheter device of claim 5 wherein said imaging apparatus is magnetic.

13. The catheter device of claim 5 wherein said imaging apparatus is sonographic.

14. The catheter device of claim 1 wherein said orientation element comprises a piezoelectric apparatus.

15. The catheter device of claim 1 wherein said orientation element is adapted to send and receive a signal to detect flow in an adjacent structure.

16. The catheter device of claim 1 wherein both of said imageable marker and said imaging apparatus are incorporated in an active orientation detection apparatus.

17. The catheter device of claim 16 wherein said active orientation detection apparatus comprises an apparatus which sends and receives a signal to detect flow in an adjacent structure.

18. The catheter device of claim 16 wherein said active orientation detection apparatus comprises an array of receviers in relationship to a transmitter for providing an image of the surrounding tissue.

19. The catheter device of claim 1 wherein said orientation element comprises a transmitter capable of sending a signal to said imageable marker, and wherein said imageable comprises a receiver/transmitter that receives the signal from said transmitter and returns a signal to the operator upon receipt of the signal from the transmitter.

20. The catheter device of claim 19 wherein said transmitter/receiver is located on a guidewire which is positionable in an anatomical location separate from the location of said imaging apparatus.

21. The catheter device of claim 1 wherein said orientation element comprises a transmitter capable of sending a signal to said imaging apparatus, said imaging apparatus has a receiver/transmitter adapted to return a signal to the operator upon receipt of a signal from the transmitter.

22. The catheter device of claim 1 wherein said orientation element comprises an imaging apparatus located on the catheter.

23. The catheter device of claim 22 wherein said imaging apparatus comprises an array of receivers and a transmitter, said array of receivers being in relationship to the transmitter for the purpose of providing an image that is useable to determine the position of the catheter within the vasculature of the patient.

24. The catheter device of claim 1 wherein said tissue penetrating member is a tissue penetrating flow of energy.

25. The catheter device of claim 1 wherein said tissue penetrating member is a tissue penetrating member that is adapted to emit a flow of energy therefrom.

26. The catheter device of claim 1 wherein said catheter body incorporates a balloon.

27. A system for accessing a location within a patient outside of the lumen of a blood vessel, the system comprising:

the catheter device of claim 1;

a guidewire adapted to pass through the guidewire lumen of the tissue penetrating member, the system being usable to locate a guidewire at the location to enable introduction of medical instrumentation to the location.

28. The system of claim 27, wherein the tissue penetrating member comprises a sheath defining the guidewire lumen therewithin, and further includes a relatively rigid probe that fits within the guidewire lumen and extends beyond a distal end of the sheath, the probe being removable from the guidewire lumen, and the guidewire being relatively more flexible than the probe.

29. A catheter device for accessing a target anatomical structure within which a flow of fluid is occurring, said target anatomical structure being located outside of the lumen of a blood vessel within which the catheter device is positioned, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, said distal portion being transluminally insertable into the vasculature of a patient, while the proximal end remains outside the body of the patient to allow for control by the operator;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned;

a flow sensing apparatus located on said catheter body and useable to (i) sense the flow of fluid in said target anatomical location, and (ii) facilitate rotational orientation of the catheter body such that the tissue penetrating element is aimed at the target anatomical location.

30. The catheter device of claim 29 wherein said tissue penetrating element is a tissue penetrating member.

31. The catheter device claim 29 wherein said tissue penetrating member is a transvascular interstitial probe.

32. The catheter device claim 31 wherein said transvascular interstitial probe is a wire.

33. The catheter device claim 31 wherein said transvascular interstitial probe is a antenna.

34. The catheter device claim 31 wherein said transvascular interstitial probe is a light guide.

35. The catheter device claim 31 wherein said transvascular interstitial probe is a energy guide.

36. The catheter device claim 30 wherein said tissue penetrating member is a transvascular interstitial sheath.

38. The catheter device claim 30 wherein said tissue penetrating member is the combination of a transvascular interstitial sheath and a transvascular interstitial probe that is advanceable through said sheath.

39. The catheter device of claim 29 wherein said tissue penetrating element is a tissue penetrating flow of energy.

40. The catheter device of claim 29 wherein said tissue penetrating element is a tissue penetrating member that is adapted to emit a flow of energy therefrom.

41. The catheter device of claim 29 wherein said catheter body incorporates a balloon.

37. The catheter device of the 36 wherein the transvascular interstitial sheath is configured to permit insertion of a guidewire therethrough.

42. A catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element which comprises (i) an imageable marker located on the distal portion of said catheter body and (ii) an imaging apparatus located other than on said catheter body for imaging said imageable marker;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vascutature of the patient such that, when the tissue penetrating element is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

43. The catheter device of claim 42, wherein said marker is a passive marker imageable by said imaging apparatus.

44. A catheter device of claim 43, wherein said passive marker is a radiopaque material and wherein said imaging apparatus is a radiographic apparatus.

45. A catheter device of claim 43, wherein said passive marker is a ferromagnetic material and wherein said imaging apparatus is a magnetic apparatus.

46. The catheter device of claim 42, wherein said marker is an active marker imageable by said imaging apparatus.

47. The catheter device of claim 42, wherein said imaging apparatus is radiographic.

48. The catheter device of claim 42, wherein said imaging apparatus is fluoroscopic.

49. The catheter device of claim 42, wherein said imaging apparatus is magnetic.

50. The catheter device of claim 42, wherein said imaging apparatus is sonographic.

51. A catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element adapted to send and receive a signal to detect flow in an adjacent structure which comprises (i) an imaging apparatus and (ii) an imageable marker, at least one of said imaging apparatus and imageable marker being located on the distal portion of said catheter body;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vascutature of the patient such that, when the tissue penetrating element is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

52. A catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element which comprises (i) an imaging apparatus and (ii) an imageable marker, at least one of said imaging apparatus and imageable marker being located on the distal portion of said catheter body, wherein both of said imageable marker and said imaging apparatus are incorporated in an active orientation detection apparatus which sends and receive a signal to detect flow in an adjacent structure;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vascutature of the patient such that, when the tissue penetrating element is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

53. A catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element which comprises (i) an imaging apparatus and (ii) an imageable marker, at least one of said imaging apparatus and imageable marker being located on the distal portion of said catheter body, wherein said orientation element comprises a transmitter capable of sending a signal to said imageable marker, and wherein said imageable marker comprises a transmitter/receiver located in a guidewire which is positionable in an anatomical location separate from the location of said imaging apparatus, the transmitter/receiver receiving the signal from said transmitter and returning a signal to the operator upon receipt of the signal from the transmitter;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vascutature of the patient such that, when the tissue penetrating element is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

54. A catheter device for accessing a location within a patient, outside of the lumen of a blood vessel, said catheter device comprising:

an elongate catheter body having a proximal end and a distal portion, the distal portion of said catheter body being transluminally insertable into the vasculature of a patient while the proximal end of the catheter body remains outside the body of the patient;

a tissue penetrating element which is passable from the distal portion of said catheter and adapted to extend beyond the lumen of the blood vessel in which said catheter is positioned; and

,

an orientation element which comprises (i) an imageable marker located other than on said catheter body and (ii) an imaging apparatus located on the distal portion of said catheter body for imaging said imageable marker;

said orientation element being useable by the operator to guide the positioning of the catheter body within the vascutature of the patient such that, when the tissue penetrating element is passed from the distal portion of the catheter body it will penetrate through the wall of the blood vessel and to said location.

55. The catheter device of claim 54, wherein said marker is a passive marker imageable by said imaging apparatus.

56. A catheter device of claim 55, wherein said passive marker is a radiopaque material and wherein said imaging apparatus is a radiographic apparatus.

57. A catheter device of claim 55, wherein said passive marker is a ferromagnetic material and wherein said imaging apparatus is a magnetic apparatus.

58. The catheter device of claim 54, wherein said marker is an active marker imageable by said imaging apparatus.

59. The catheter device of claim 54, wherein said imaging apparatus is radiographic.

60. The catheter device of claim 54, wherein said imaging apparatus is fluoroscopic.

61. The catheter device of claim 54, wherein said imaging apparatus is magnetic.

62. The catheter device of claim 54, wherein said imaging apparatus is sonographic.