Methods for minimally invasive vascular access

• US 20060224110A1
• Filed: 03/17/2005
• Published: 10/05/2006
• Est. Priority Date: 03/17/2005
• Status: Abandoned Application

• Current Assignee: ORQIS Medical Corporation
• Original Assignee: ORQIS Medical Corporation
• Inventors: Scott, Michael J., Radovancevic, Branislav
• Application Number:
  US11/083,042
• Publication Number:
  US 20060224110A1
• Time in Patent Office: Days
• US Class Current: 604/95.10
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/562 for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow

Abstract

The present methods provide access to high flow vessels without causing severe trauma for the patient. At the same time, the methods maximize the size of a vascular instrument that can be deployed at the target location. The methods involve tunneling through the patient'"'"'s tissue to create an access path between a percutaneous access site and the target location by using a second percutaneous site that is generally subcutaneous.

Claims

1. A method for minimally invasive access to a target location in a patient'"'"'s vasculature, the target location being buried deep beneath the patient'"'"'s skin such that a relatively large amount of bodily tissue and/or organs lie between a first percutaneous site and the target location, the target location being accessible from a second percutaneous site where the vasculature is located relatively close to the skin, the vasculature at the target location including a vessel segment with a first perimeter that is larger than a second perimeter of a second vessel segment located near the second percutaneous site, the method comprising the steps of:

puncturing a patient'"'"'s skin and vasculature with a needle at the second percutaneous site;

inserting a guide wire through the needle and into the vasculature at the second percutaneous site;

removing the needle from the vasculature;

advancing the guide wire through the vasculature, with the aid of a visualization apparatus, to the target location;

advancing a dilator over the guide wire and inserting the dilator into the vasculature at the second percutaneous site, thereby widening an opening in the vasculature at the second percutaneous site;

advancing a tunneling device having a cover through the vasculature, with the further aid of the visualization apparatus, along the guide wire from the second percutaneous site to the target location, the tunneling device being configured to be steerable and having a distal point capable of penetrating the vasculature and tissue between the vasculature and the skin, the cover protecting the vasculature as the device travels through the vasculature;

piercing the vasculature wall with the tunneling device at the target location and advancing the tunneling device through the vasculature wall and through the patient'"'"'s tissue, with the further aid of the visualization apparatus, avoiding sensitive bodily structures, to the first percutaneous site; and

inserting a conduit through the first percutaneous site, through the patient'"'"'s tissue, and into the vasculature at the target location.

2. The method of claim 1, wherein the second percutaneous site is proximate an artery.

3. The method of claim 2, wherein the artery is the axillary artery, the femoral artery, the subclavian artery, the common carotid artery, or the brachiocephalic artery.

4. The method of claim 1, wherein the second percutaneous site is proximate a vein.

5. The method of claim 4, wherein the vein is the femoral vein, the great saphenous vein, the internal or external jugular vein, the subclavian vein or the basilic vein.

6. The method of claim 1, wherein the target location is in an artery.

7. The method of claim 6, wherein the artery is the common femoral artery, the common iliac artery, the abdominal aorta, the axillary artery, the subclavian artery, or the brachiocephalic artery.

8. The method of claim 1, wherein the target location is in a vein.

9. The method of claim 8, wherein the vein is the common femoral vein, the common iliac vein, the inferior vena cava, the superior vena cava, the axillary vein, the subclavian vein, the external or the internal jugular vein, or the basilic vein.

10. The method of claim 1, wherein the visualization apparatus comprises one or more of a fiber-optic camera, ultrasound apparatus or fluoroscopy apparatus.

11. The method of claim 1, further comprising the step of advancing the conduit from the target location to the aortic arch, the abdominal aorta, the axillary artery, the inferior or superior vena cava, the axillary vein, or the renal artery.

12. The method of claim 1, wherein the tunneling device comprises a tunneling catheter.

13. The method of claim 12, wherein the tunneling device further comprises a dissection tip, a trocar tip, a hollow catheter with an external cutter, a blunt dissection tip, a laser tip, an RF tip, an electrosurgical tip, or an ultrasound tip.

14. A method for minimally invasive access to a target location in a patient'"'"'s vasculature, the target location being buried deep beneath the patient'"'"'s skin such that a relatively large amount of bodily tissue and/or organs lie between a first percutaneous site and the target location, the target location being relatively easy to access from a second percutaneous site where the vasculature is located relatively close to the skin, the vasculature at the target location including a vessel segment with a first perimeter that is larger than a second perimeter of a second vessel segment located near the second percutaneous site, the method comprising the steps of:

advancing a tunneling device into the vasculature at the second percutaneous site;

advancing the tunneling device through the vasculature from the second percutaneous site to the target location; and

advancing the tunneling device through the vasculature at the target location, through the patient'"'"'s tissue, and through the patient'"'"'s skin at the first percutaneous site.

15. The method of claim 14, further comprising the step of inserting a conduit through the first percutaneous site, through the patient'"'"'s tissue, and into the vasculature at the target location.

16. A method for minimally invasive access to a target location in a patient'"'"'s vasculature that includes a vessel segment with a relatively large perimeter, the target location being buried deep beneath the patient'"'"'s skin, such that a relatively large amount of bodily tissue and/or organs lie between a percutaneous site and the target location, the method comprising the steps of:

puncturing a patient'"'"'s skin with a needle at the percutaneous site;

inserting a tunneling device through the patient'"'"'s skin at the percutaneous site;

advancing the tunneling device through the patient'"'"'s tissue beneath the percutaneous insertion site, with the aid of a visualization apparatus, so as to avoid sensitive bodily structures, to the vasculature, thereby creating a pathway from the percutaneous insertion site to the vasculature proximate the target location;

removing the tunneling device from the pathway;

advancing a sheath, with the further aid of the visualization apparatus, along the pathway to the vasculature proximate the target location, an end of the sheath including apparatus configured to capture the vasculature;

capturing the vasculature with the capturing apparatus and with the further aid of the visualization apparatus;

piercing a wall of the vasculature with a hollow structure, and with the further aid of the visualization apparatus, to produce a vascular opening;

removing the hollow structure from the vascular opening;

advancing a dilator along the guide wire, with the further aid of the visualization apparatus, and through the vascular opening to widen the opening; and

advancing a conduit along the guide wire, with the further aid of the visualization apparatus, through the vascular opening, and into the vasculature at the target location.

17. The method of claim 16, further comprising:

advancing a guide wire through the sheath to the vasculature, with the further aid of the visualization apparatus;

advancing the hollow structure along the guide wire to the vasculature, with the further aid of the visualization apparatus; and

advancing the guide wire through the vascular opening, with the further aid of the visualization apparatus, and into the vasculature at the target location.

18. The method of claim 16, wherein the target location is in an artery.

19. The method of claim 18, wherein the artery is the common femoral artery, the common iliac artery, the abdominal aorta, the axillary artery, the subclavian artery, or the brachiocephalic artery.

20. The method of claim 16, wherein the target location is in a vein.

21. The method of claim 20, wherein the vein is the common femoral vein, the common iliac vein, the inferior vena cava, the superior vena cava, the axillary vein, the subclavian vein, the external or the internal jugular vein, or the basilic vein.

22. The method of claim 16, wherein the visualization apparatus comprises one or more of a fiber-optic camera, ultrasound apparatus or fluoroscopy apparatus.

23. The method of claim 16, further comprising the step of advancing the conduit from the target location to the aortic arch, the abdominal aorta, the axillary artery, the inferior or superior vena cava, the axillary vein, or the renal artery.

24. The method of claim 16, wherein the tunneling device comprises a simple dissection tip, a trocar-type tip, a hollow catheter with an extendable cutter, a blunt dissection tip or a laser tip.

25. The method of claim 16, wherein the tunneling device is straight, angled, curved or anatomically shaped.

26. A method for minimally invasive access to a target location in a patient'"'"'s vasculature that includes a vessel segment with a relatively large perimeter, the target location being buried deep beneath the patient'"'"'s skin, such that a relatively large amount of bodily tissue and/or organs lie between a percutaneous site and the target location, the method comprising the steps of:

puncturing a patient'"'"'s skin with a needle at the percutaneous site;

inserting a tunneling device through the patient'"'"'s skin at the percutaneous site, the tunneling device comprising a removable core with a tunneling tip;

advancing the tunneling device through the patient'"'"'s tissue beneath the percutaneous insertion site, with the aid of a visualization apparatus, so as to avoid sensitive bodily structures, to the vasculature, thereby creating a pathway from the percutaneous insertion site to the vasculature proximate the target location;

extending capturing apparatus from the tunneling device and, with the further aid of the visualization apparatus, capturing the vasculature with the capturing apparatus;

removing the core from the tunneling device;

advancing a hollow structure through the tunneling device to the vasculature, with the further aid of the visualization apparatus;

piercing a wall of the vasculature with the hollow structure, and with the further aid of the visualization apparatus, to produce a vascular opening;

removing the hollow structure from the vascular opening;

advancing a dilator through the patient'"'"'s tissue, with the further aid of the visualization apparatus, and through the vascular opening to widen the opening;

advancing a conduit through the patient'"'"'s tissue, with the further aid of the visualization apparatus, through the vascular opening, and into the vasculature at the target location.

27. The method of claim 26, further comprising:

advancing a guide wire through the tunneling device to the vasculature, with the further aid of the visualization apparatus;

advancing the hollow structure along the guide wire to the vasculature, with the further aid of the visualization apparatus; and

advancing the guide wire through the vascular opening, with the further aid of the visualization apparatus, and into the vasculature at the target location;

28. A method for minimally invasive access to a target location in a patient'"'"'s vasculature that includes a vessel segment with a relatively large perimeter, the target location being buried deep beneath the patient'"'"'s skin, such that a relatively large amount of bodily tissue and/or organs lie between a percutaneous site and the target location, the method comprising the steps of:

inserting a tunneling device through a patient'"'"'s skin at the percutaneous site;

advancing the tunneling device through the patient'"'"'s tissue beneath the percutaneous site to the vasculature proximate the target location, thereby creating a pathway from the percutaneous site to the vasculature proximate the target location;

piercing a wall of the vasculature to create a vascular opening; and

advancing a conduit along the pathway, through the vascular opening, and into the vasculature at the target location.

29. A tunneling device for permitting a clinician to reach a target location of a patient'"'"'s vasculature that is deeper than subcutaneous from a percutaneous site that is remote from the target portion, the tunneling device comprising an elongate portion configured to pass through the patient'"'"'s vasculature, the elongate portion having a distal end configured to cut through the vasculature and tissue.

30. The tunneling device of claim 29, wherein the distal end comprises a cutting edge.

31. The tunneling device of claim 30, wherein the cutting edge is retractable.

32. The tunneling device of claim 29, wherein the tunneling device is remotely steerable.