Device, system and method for interstitial transvascular intervention

• US 20040073238A1
• Filed: 04/29/2003
• Published: 04/15/2004
• Est. Priority Date: 02/02/1996
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua
• Granted Patent: US 8,075,580 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/12136 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 17/3417 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 2017/00504 : Tissue welding
• 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 2018/00404 : Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• 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 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector

Abstract

Devices, systems and methods for transvascular interstitial interventions, including transvascular, catheter based vascular bypass, transmyocardial revascularization, bypass grafting of blood vessels, and interstitial surgical/interventional procedures wherein a catheter is advanced translumenally through the vasculature to a desired location and an operative instrument is passed through the wall of a blood vessel and to a target location (e.g. another blood vessel, an organ, a tumor, another anatomical structure) such that one or more operative devices may be advanced to the target location to perform the desired operative or interventional procedure.

Claims

1. A method for bypassing a blocked segment of a blood vessel in a mammalian patient, said method comprising the steps of:

a) providing a tubular bypass graft having at least one end and a hollow lumen which extends which extends longitudinally therethrough;

b) locating an end of said bypass graft in juxtaposition to a blood vessel, at a location which is downstream of the obstruction;

C) inserting a passageway-forming probe device in to the lumen of the bypass graft, said passageway forming probe device comprising an elongate member which has an outlet opening formed thereon and a tissue penetrating element which is passable out of said outlet opening to penetrate through the wall of the bypass graft and through tissue which is juxtapositioned to said bypass graft wall;

d) positioning the passageway forming probe device within the lumen of the bypass graft such that the outlet opening of the probe device is adjacent the location at which the bypass graft is to be connected to the blood vessel;

e) causing the tissue penetrating element of the probe device to pass out of the outlet opening, through the wall of the bypass graft, and through the juxtapositioned wall of the blood vessel, thereby forming first openings in the wall of the bypass graft and the blood vessel;

f) securing the bypass graft to the blood vessel such that the first opening in the bypass graft will be maintained in substantial alignment with the first opening of the blood vessel, and further such that blood will flow between the bypass graft and the blood vessel through said first openings.

2. The method of claim 1 wherein the tubular bypass graft provided in step A is one of the patient'"'"'s blood vessels which has been transected, thereby forming a first transected end, and has been permitted to remain connected to its endogenous blood supply, said transected end being the only end of the bypass graft, and said first opening being the only opening connected to said blood vessel.

3. The method of claim 2 wherein the method is carried out for the purpose of bypassing a coronary artery, and wherein said bypass graft is the patient'"'"'s internal mammary artery.

4. The method of claim 1 wherein the bypass graft provided in step A is a tube graft having first and second ends.

5. The method of claim 4 wherein said tube graft is a biological graft.

6. The method of claim 4 wherein said tube graft is a synthetic graft.

8. The method of claim 4 wherein the first end of the tubular bypass graft is juxtapositioned to the blood vessel in step b of the method, and wherein said method further comprises the additional steps of:

g) locating the second end of the bypass graft in juxtaposition to a blood vessel;

h) repositioning the passageway-forming probe device within the lumen of the bypass graft such that the outlet opening of the probe device is adjacent the location at which there is to be formed a second connection between said bypass graft and a blood vessel;

i) causing the tissue penetrating element of the probe device to pass out of the outlet opening, through the wall of the bypass graft, and through the juxtapositioned wall of the blood vessel, thereby forming second openings in the wall of the bypass graft and the blood vessel;

j) securing the bypass graft to the blood vessel such that the second opening in the bypass graft will be maintained in substantial alignment with the second opening in the blood vessel, and further such that blood will flow between the bypass graft and the blood vessel through said second openings.

9. The method of claim 1 wherein said first opening in the bypass graft is a side opening, and wherein the method further comprises the step of:

closing any open ends of the bypass graft to prevent blood from leaking from said bypass graft.

10. The method of claim 9 wherein at least one end of said bypass graft is closed by a closure apparatus selected from the group of closure apparatus consisting of:

a ligature;

a staple;

a clip;

a plug;

a cap;

a lumen blocking device;

a quantity of adhesive; and

,

a quantity of glue.

11. The method of claim 1 wherein step f is accomplished by an attachment means selected from the group of attachment means consisting of:

adhesive;

suture;

energy based welding;

glue;

at least one magnet; and

,

a connector apparatus which is implantable within said first openings formed in said blood vessel and said bypass graft.

12. The method of claim 8 wherein the steps f and j of the method are accomplished by an attachment means selected from the group of attachment means consisting of:

adhesive;

suture;

energy based welding;

glue;

at least one magnet; and

,

connector apparatus which are implantable in the first and second openings formed in said blood vessel and said bypass graft.

13. The method of claim 1 wherein an opening is formed in the side of the bypass graft to permit said passageway-forming probe to be passed thereinto, and wherein said method further comprises the step of:

closing the opening in the side of the bypass graft after the passageway-forming probe has been removed.

14. The method of claim 1 wherein the passageway forming probe is inserted through a side branch which exists in the bypass graft, and wherein the method further comprises the step of:

closing the side branch of the bypass graft after the passageway-forming probe has been removed.

16. The welding catheter system of claim 14 wherein said first approximation member is a balloon.

26. The method of claim 1 wherein step e of the method comprises causing a tissue penetrating member to pass out of the outlet opening, through the wall of the bypass graft, and through the juxtapositioned wall of the blood vessell.

27. The method of claim 26 wherein said tissue penetrating member has a guide wire lumen extending therethrough, and wherein step e further comprises:

passing a guide wire through the lumen of the tissue penetrating member and into the blood vessel, such that said guide wire may remain in the blood vessel after the tissue penetrating member has been retracted into the probe.

28. The method of claim 1 wherein step e comprises passing a tissue penetrating flow of energy from the probe, through the wall of the bypass graft and through the juxtapositioned wall of the blood vessel.

29. The method of claim 8 wherein step i of the method comprises causing a tissue penetrating member to pass out of the outlet opening, through the wall of the bypass graft, and through the juxtapositioned wall of the blood vessell.

30. The method of claim 29 wherein said member has a guide wire lumen extending therethrough, and wherein step i further comprises:

passing a guide wire through the lumen of the tissue penetrating member and into the blood vessel, such that said guide wire may remain in the blood vessel after the tissue penetrating member has been retracted into the probe.

31. The method of claim 8 wherein step i comprises passing a tissue penetrating flow of energy from the probe, through the wall of the bypass graft and through the juxtaposition wall of the blood vessel.

15. A welding catheter system for using openings formed in the walls of adjacently situated first and second anatomical structure such that fluid may flow from one of said anatomical structures, through said openings, and into the other of said anatomical structures, said welding catheter system comprising:

an elongate catheter body having a proximal end, a distal, said elongate catheter body being passable through said openings formed in said anatomical structure;

a first approximation member formed at a first location on the catheter;

a second approximation member formed at a second location on the catheter, proximal to said first location;

tissue fusing apparatus for fusing tissue between the first and second approximation members;

said first and second approximation members being operable to compress said openings toward one another, and said tissue fusing apparatus being concurrently activatable to cause said first and second openings and any tissue disposed therebetween to become fused.

17. The welding catheter system of claim 15 wherein said second approximation member is a balloon.

18. The welding catheter system of claim 15 wherein said tissue-fusing apparatus is an energy emitting apparatus adapted to emit an energy type selected from the group of energy types consisting:

heat;

laser light;

electrical current;

radiofrequency energy; and

,

ultrasound.

19. The welding catheter system of claim 15 wherein the tissue fusing apparatus is an adhesive-applying apparatus operative to apply an adhesive to tissue adjacent and between said first and second openings.

20. The welding catheter system of claim 15 wherein said tissue fusing apparatus is a chemical delivering apparatus which is operative to deliver a tissue fusing chemical to tissues adjacent and between said first and second openings.

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

a) forming at least one transmyocardial passageway between a coronary vein and a chamber of the heart such that blood from the chamber of the heart will pass through said passageway and into said coronary vein.

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

b) allowing the lumen of the coronary vein to remain unobstructed such that venous blood flow may continue through the lumen of said coronary vein.

23. The method of claim 21 wherein step a comprises forming a plurality of said transmyocardial passageways between said coronary vein and said chamber of the heart.

24. The method of claim 21 wherein the chamber of the heart is the left ventricle.

25. The method of claim 21 wherein step a is performed by transluminally advancing, into said coronary vein, a passageway forming catheter having a tissue penetrating element which is passable from said catheter, through the wall of said coronary vein and through the myocardium, thereby forming said at least one transmyocardial passageway.

32. The method of claim 25 wherein the penetrating element comprises a member which passes out of the outlet opening, through the wall of the bypass graft, and through the juxtapositioned wall of the blood vessell.

33. The method of claim 32 wherein said member has a guide wire lumen extending therethrough, and wherein the method further comprises:

passing a guide wire through the lumen of the tissue penetrating member and into the blood vessel, such that said guide wire may remain in the blood vessel after the tissue penetrating member has been retracted into the probe.

34. The method of claim 25 wherein said tissue penetrating element comprises a flow of energy which passes from said catheter, through the wall of the bypass graft and through the juxtapositioned wall of the blood vessel.