Devices, systems, and methods for lead delivery

• US 9,023,075 B2
• Filed: 05/11/2010
• Issued: 05/05/2015
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US12/777,890
• Publication Number:
  US 20100312256A1
• Time in Patent Office: 1,820 Days
• Field of Search: 606/129, 606/192, 606193-199, 606/191, 604/93.01, 604/96.01, 604/97.01, 604/98, 604/1, 604/99.01, 60410101-10104, 60410301-10305, 600/116
• US Class Current: 606/192
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0091 the single injection needle being fixed
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61N 1/057 : Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 : Anchoring means
• CPC Class Codes: A61N 1/0592 : Introducing the lead through the pericardium with a needle
• CPC Class Codes: A61N 2001/058 : Fixing tools

Abstract

Devices, systems, and methods for lead delivery. In at least one exemplary embodiment of a catheter for delivering a lead within a mammalian body of the present disclosure, the catheter comprises an elongated tube comprising a wall extending from a proximal end to a distal end, a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet for delivering a lead, a balloon chamber positioned at or near the distal end of the elongated tube, and at least one balloon positioned within the balloon chamber, the at least one balloon capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein.

Claims

1. A catheter for delivery of a lead within a mammalian body, comprising:

an elongated tube comprising a wall extending from a proximal end to a distal end;

a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet for delivering a lead;

a balloon chamber integral to the elongated tube and defined within a relative side of the wall at or near the distal end of the elongated tube; and

a balloon group positioned within the balloon chamber, the balloon group comprising a central compliance balloon, a first lateral balloon, and a second lateral balloon, the balloon group capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein, wherein inflation of the balloon group causes the balloon group to protrude from the balloon chamber on the relative side of the wall of the elongated tube, wherein when inflated the balloon group does not surround the entire circumference of the elongated tube.

2. The catheter of claim 1, further comprising:

an inflation tube coupled to the at least one balloon, the inflation tube capable of delivering a gas and/or a liquid to the at least one balloon to inflate the at least one balloon.

3. The catheter of claim 1, further comprising:

an orifice defined at or near the distal end of the elongated tube, whereby a substance may be delivered through the elongated tube, out of the orifice, and into the mammalian body when at least a portion of the elongated tube is positioned therein.

4. The catheter of claim 3, wherein the elongated tube defines a lumen sized and shaped to permit a needle to be positioned therein so that a needle tip of the needle may extend out of the orifice to puncture a heart tissue.

5. The catheter of claim 1, further comprising:

a steering wire system comprising a first steering wire, a second steering wire, and a controller, the first steering wire and the second steering wire each attached to the elongated tube at or near the distal end of the elongated tube, the controller attached at or near a proximal end of each of the first steering wire and the second steering wire, the steering wire system capable of bending the elongated tube upon operation of the controller.

6. The catheter of claim 1, wherein the lead delivery channel has a bend that is approximately 90 degrees at or near the outlet.

7. The catheter of claim 1, wherein at least part of the elongated tube is sized and shaped to fit within a right atrial wall or a right atrial appendage, and wherein at least part of the elongated tube is further sized and shaped to fit within a pericardial space surrounding a heart.

8. The catheter of claim 1, wherein the central compliance balloon has a larger inflated cross-sectional area than either the first lateral balloon or the second lateral balloon.

9. The catheter of claim 1, configured so that wherein when the distal end of the elongated tube is positioned into a pericardial space surrounding a heart, the lead can be delivered through the lead delivery channel, out of the outlet, and into the heart.

10. The catheter of claim 1, configured for perceutaneous intravascular insertion and delivery through a mammalian vasculature so that the distal end of the elongated tube is positioned into a pericardial space surrounding a heart.

11. A catheter for delivery of a lead within a mammalian body, comprising:

an elongated tube comprising a wall extending from a proximal end to a distal end;

a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet for delivering a lead;

a balloon chamber integral to the elongated tube and defined within a relative side of the wall at or near the distal end of the elongated tube; and

a balloon group positioned within the balloon chamber, the balloon group comprising a central compliance balloon, a first lateral balloon, and a second lateral balloon, the balloon group capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein, wherein inflation of the balloon group causes the balloon group to protrude from the balloon chamber on the relative side of the wall of the elongated tube, and wherein when inflated the balloon group does not surround the entire circumference of the elongated tube;

an inflation tube coupled to the balloon group, the inflation tube capable of delivering a gas and/or a liquid to the balloon group to inflate the balloon group; and

a steering wire system comprising a first steering wire, a second steering wire, and a controller, the first steering wire and the second steering wire each attached to the elongated tube at or near the distal end of the elongated tube, the controller attached at or near a proximal end of each of the first steering wire and the second steering wire, the steering wire system capable of bending the elongated tube upon operation of the controller.

12. The catheter of claim 11, wherein the central compliance balloon has a larger inflated cross-sectional area than either the first lateral balloon or the second lateral balloon.

13. The catheter of claim 11, configured so that wherein when the distal end of the elongated tube is positioned into a pericardial space surrounding a heart, the lead can be delivered through the lead delivery channel, out of the outlet, and into the heart.

14. The catheter of claim 11, configured for perceutaneous intravascular insertion and delivery through a mammalian vasculature so that the distal end of the elongated tube is positioned into a pericardial space surrounding a heart.

15. A system for delivering a lead within a mammalian body, comprising:

an elongated tube comprising a wall extending from a proximal end to a distal end;

a lead delivery channel within the elongated tube, the lead delivery channel defining an outlet;

a lead having a lead tip, the lead configured for at least partial insertion into the lead delivery channel and delivery to a heart tissue from the lead delivery channel outlet;

a balloon chamber integral to the elongated tube and defined within a relative side of the wall at or near the distal end of the elongated tube; and

a balloon group positioned within the balloon chamber, the balloon group comprising a central compliance balloon, a first lateral balloon, and a second lateral balloon, the balloon group capable of inflation to reversibly anchor the elongated tube within a mammalian body when at least a portion of the elongated tube is positioned therein, wherein inflation of the balloon group causes the balloon group to protrude from the balloon chamber on the relative side of the wall of the elongated tube, wherein when inflated the balloon group does not surround the entire circumference of the elongated tube.

16. The system of claim 15, wherein the lead comprises a pacing lead, and wherein the lead tip has a substantially screw-like shape.

17. The system of claim 15, wherein the lead comprises a sensing lead.

18. The system of claim 15, further comprising:

an inflation tube coupled to the balloon group, the inflation tube capable of delivering a gas and/or a liquid to the balloon group to inflate the balloon group.

19. The system of claim 15, further comprising:

a steering wire system comprising a first steering wire, a second steering wire, and a controller, the first steering wire and the second steering wire each attached to the elongated tube at or near the distal end of the elongated tube, the controller attached at or near a proximal end of each of the first steering wire and the second steering wire, the steering wire system capable of bending the elongated tube upon operation of the controller.

20. The system of claim 15, wherein the central compliance balloon has a larger inflated cross-sectional area than either the first lateral balloon or the second lateral balloon.

21. The system of claim 15, configured so that wherein when the distal end of the elongated tube is positioned into a pericardial space surrounding a heart, the lead can be delivered through the lead delivery channel, out of the outlet, and into the heart.

22. A method of placing a lead in a tissue of a heart, the method comprising the steps of:

introducing into a blood vessel at least part of an elongated tube comprising a wall extending from a proximal end to a distal end;

advancing the distal end of the elongated tube into a pericardial space surrounding a heart;

positioning the distal end of the elongated tube within the pericardial space so that an outlet of a lead delivery channel of the elongated tube is positioned adjacent to a targeted heart tissue;

inflating a balloon group positioned within a balloon chamber at or near the distal end of the elongated tube to anchor the elongated tube within the pericardial space, the balloon group comprising a central compliance balloon, a first lateral balloon, and a second lateral balloon, and the balloon chamber integral to the elongated tube and defined within a relative side of the wall at or near the distal end of the elongated tube, wherein inflation of the balloon group causes the balloon group to protrude from the balloon chamber on the relative side of the wall of the elongated tube, wherein when inflated the balloon group does not surround the entire circumference of the elongated tube; and

delivering a lead through the lead delivery channel, out of the outlet, and into the targeted heart tissue.

23. The method of claim 22, further comprising the step of:

deflating the balloon group to de-anchor the elongated tube so that the elongated tube may be withdrawn from the blood vessel.

24. The method of claim 22, wherein inflation of the balloon group causes the balloon group to exert pressure against the heart and a pericardial sac surrounding the heart.

25. The method of claim 22, further comprising the step of:

delivering a substance within the pericardial space through an orifice defined at an end of a lumen within the elongated tube.