Device, system and method for interstitial transvascular intervention

• US 6,068,638 A
• Filed: 10/27/1998
• Issued: 05/30/2000
• 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:
  US09/179,809
• Time in Patent Office: 581 Days
• Field of Search: 606/1, 606/108, 606/153-156, 606/159, 606/184, 606/185, 600/16-18, 623/1, 623/12, 128/899
• 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 revascularization, said method comprising the steps of:

(A) providing channel forming apparatus that can be transluminally inserted into a first blood containing anatomical structure and is useable to form an extravascular channel from said first blood-containing anatomical structure to a second blood containing anatomical structure, wherein at least one of said anatomical structures contains oxygenated blood;

(B) using said apparatus to form at least one non-valved blood flow channel from said first blood-containing anatomical structure to said second blood containing anatomical structure, said non-valved blood flow channel remaining open during systole and diastole such that oxygenated blood may flow continuously through said channel.

2. The method of claim 1 wherein the artery is a coronary artery.

3. The method of claim 1 wherein the vein is a coronary vein.

4. The method of claim 1 wherein said method further comprises the step of:

(C) placing at least one blocking apparatus in one of said first blood-containing anatomical structures to facilitate said continuous blood flow through said channel.

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

(C) placing a stent at least partially within said channel.

6. The method of claim 5 wherein said stent is valved to permit blood flow in only one direction.

7. The method of claim 5 wherein said stent is wholly located within said channel.

8. The method of claim 5 wherein said stent protrudes from said channel into at least one of said anatomical structures.

9. The method of claim 5 wherein said stent is an in-situ formed polymer stent.

10. The method of claim 5 wherein the stent is at least partially covered with a membrane.

11. The method of claim 10 wherein said membrane is disposed on said stent such that said membrane operates to block blood flow in at least one flow direction.

12. The method of claim 5 wherein said stent comprises a covering to form a barrier adjacent the wall of the channel.

14. The method of claim 1 wherein the channel forming apparatus provided in step (A) comprises:

(i) an apparatus for forming an initial penetration tract between said anatomical structures and;

(ii) an apparatus for enlarging the initial penetration tract to form said channel.

15. The method of claim 14 wherein the apparatus for enlarging the initial penetration tract is a balloon usable to enlarge said initial penetration tract.

16. The method of claim 14 wherein the apparatus for enlarging the initial penetration tract is a tissue cutting apparatus useable to enlarge said initial penetration tract.

17. The method of claim 14 wherein the apparatus for enlarging the initial penetration tract is an energy emitting apparatus useable to enlarge said initial penetration tract.

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

(C) placing a clip member at least partially in said channel to maintain approximation of said blood vessels such that flow is facilitated through said channel.

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

(C) heating tissue adjacent to said channel to a sufficient temperature for a sufficient period of time to cause fusion of said tissue.

20. The method of claim 19 wherein step C includes the act of longitudinally compressing said tissue while said tissue is heated.

21. The method of claim 1 wherein the channel forming apparatus provided in step (A) includes at least a first apparatus for forming an initial penetration tract between said anatomical structures, a guide wire;

and a second apparatus for modifying the initial penetration tract, and wherein step (B) comprises;

(i) using said first apparatus to form said initial penetration tract;

(ii) placing said guide wire through said initial penetration tract; and

, thereafter,

(iii) advancing said second apparatus over said guide wire and using said second apparatus to modify said initial penetration tract.

22. The method of claim 21 wherein the guidewire is placed in the initial penetration tract as part of the operation of the first apparatus.

23. The method of claim 22 wherein the apparatus provided in step A comprises a tissue penetrating member having a lumen extending therethrough, and wherein the guidewire is advanced through the lumen of the tissue penetrating member after the tissue penetrating member has been used to form the initial penetration tract.

24. The method of claim 1 wherein the first blood-containing anatomical structure is of a first size, and wherein the second blood-containing anatomical structure is of a second size, and wherein the method further comprises:

(C) placing a stent within the channel, said stent having a first end dimensioned to correspond to the size of the first anatomical structure, and a second end dimensioned to correspond to the size of the second anatomical structure.

25. The method of claim 24 wherein said stent extends through said channel and its first end protrudes into the first anatomical structure, and its second end protrudes into the second anatomical structure.

26. The method of claim 24 wherein the first end of the stent is expandable to a first diameter which corresponds to the size of the first anatomical strucutre, and the second end of the stent is expandable to a second diameter which corresponds to the size of the second anatomical structure.

27. The method of claim 1 wherein said method further comprises the step of:

(C) injecting a flow of contrast material through said channel to facilitate imaging of said channel.

13. The method of the 12 wherein said covering is formed of material which will dissolve after a period of time.

28. A method for revascularization, said method comprising the steps of:

(A) providing channel forming apparatus that can be transluminally inserted into a coronary blood vessel that has a vessel wall and is useable to penetrate through the wall of the coronary blood vessel in which it is positioned and into the myocardium thereby forming a dead-end channel from said coronary blood vessel into the myocardium;

(B) transluminally inserting said channel forming apparatus into a coronary blood vessel; and

,

(C) causing the channel forming apparatus to penetrate through the wall of the coronary blood vessel in which it is positioned and into the myocardium, thereby forming said dead-end channel from said coronary blood vessel into the myocardium.

29. The method of claim 28 wherein the coronary blood vessel in which the channel forming apparatus is positioned is a coronary artery.

30. The method of claim 28 wherein the coronary blood vessel in which the channel forming apparatus is positioned is a coronary vein that has been connected to a source of arterial blood such that arterial blood is flowing through the region of said coronary vein wherein the interstitial channel is formed.

31. A method for establishing a blood flow conduit between a first tubular blood vessel that has a vessel wall and a second tubular blood vessel that has a vessel wall, wherein at least one of said first and second tubular blood vessels contains oxygenated blood, said method comprising the steps of:

(a) providing at least one apparatus that can be transluminally inserted into at least one of the tubular blood vessels and is useable to form openings in the walls of the first and second tubular blood vessels as well as a blood flow conduit between said openings; and

,

(b) using said at least one apparatus to form openings in the walls of the first and second blood vessels and to establish a blood flow conduit between said openings, such that oxygenated blood may flow through said blood flow conduit.

32. The method of claim 31 wherein the first blood vessel is an artery that contains oxygenated blood, and the second blood vessel is a coronary blood vessel.

33. The method of claim 31 wherein the second blood vessel is a vein.

34. The method of claim 33 wherein the second blood vessel is a coronary vein.

35. The method of claim 31 wherein the second blood vessel is an artery.

36. The method of claim 35 wherein the second blood vessel is a coronary artery.

37. The method of claim 35 wherein the second blood vessel is a coronary artery having an obstruction formed therein and wherein the opening in the second blood vessel is formed distal to said obstruction.

38. The method of claim 31 wherein said method farther comprises the step of:

(c) placing at least one blocking apparatus in one of said first or second blood vessels.

39. The method of claim 38 wherein one of said first or second blood vessels is a vein and wherein the blocking apparatus is placed in the vein.

40. The method of claim 31 farther comprising the step of:

(c) placing a stent at least partially within said blood flow conduit.

41. The method of claim 40 wherein the stent is valved to permit blood flow in only one direction.

42. The method of claim 31 wherein the apparatus provided in step (a) comprises:

(1) apparatus for forming initial openings in the walls of the first and second blood vessels; and

,

(2) apparatus for enlarging the initial openings formed the walls of the first and second blood vessels.

43. The method of claim 39 wherein the apparatus for enlarging the initial penetrations formed in at least the walls of the first and second blood vessels is selected from the group consisting of:

(1) a dilating apparatus usable to enlarge said initial penetration tract;

(2) a tissue cutting apparatus useable to enlarge said initial penetration tract; and

(3) an energy emitting apparatus useable to enlarge said initial penetration tract.

44. The method claim 43 wherein the dilating apparatus is selected from the group of dilating apparatus consisting of:

a dilator; and

,

a balloon.

45. The method of claim 31 wherein Step (a) comprises:

(1) providing apparatus for forming openings through the walls of the first and second blood vessels; and

,

(2) providing apparatus for deploying a tubular conduit between the openings formed in the walls of the first and second blood vessels, thereby establishing said blood flow conduit through which oxygenated blood may flow; and

,

wherein Step (b) comprises;

(3) using the apparatus provided in Step A (1) to form said openings in the walls of the first and second blood vessels; and

,

(4) using the apparatus provided in Step A (2) to deploy the tubular conduit between the openings in the walls of the first and second blood vessels, thereby establishing said blood flow conduit through which oxygenated blood may flow.

46. The method of claim 45 wherein tissue exists between the locations at which the openings are to be formed in the first and second blood vessel walls, and wherein;

the apparatus provided in Step A (1) is or are useable to penetrate through said tissue as well as through said first and second blood vessel walls, thereby forming an interstitial channel through said tissue; and

,

the apparatus provided in Step A (2) is or are useable to deploy said tubular conduit at least partially through the interstitial channel created by the first apparatus.

47. The method of claim 45 wherein, prior to deployment of said conduit, at least some open space exists between the locations on the first and second blood vessel walls at which the openings are formed and wherein;

the apparatus provided in Step A (1) is or are useable to form said openings in the first and second blood vessel walls; and

,

the apparatus provided in Step A (2) is or are useable to deploy the tubular conduit through the open space between said openings, thereby establishing said blood flow conduit through which oxygenated blood may flow.