WO2014186323A1

WO2014186323A1 - Delivery system to deploy pacing or defibrillation leads in the vascular system

Info

Publication number: WO2014186323A1
Application number: PCT/US2014/037781
Authority: WO
Inventors: Harikrishna Tandri
Original assignee: The Johns Hopkins University
Priority date: 2013-05-13
Filing date: 2014-05-13
Publication date: 2014-11-20

Abstract

An embodiment in accordance with the present invention provides a device and method for placing electrical leads in a desired location in the heart of a patient. A device of the present invention includes a guide wire that can be inserted through the vasculature and into a chamber of the heart near a desired location for electrical lead placement. A delivery catheter having a first lumen configured to accommodate at least one electrical lead for placement in the heart and a second lumen configured to accommodate the guide wire, is advanced over the guide wire to a position near that of the desired location for electrical lead placement. In this way, the electrical leads are delivered to the desired location. The guide wire can include a balloon tip for more accurate positioning and the catheter can include a terminal deflectable portion that deviates slightly from the path of the guide wire.

Description

DELIVERY SYSTEM TO DEPLOY PACING

OR DEFIBRILLATION LEADS IN THE VASCULAR SYSTEM

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Patent Application No.

61/822,513 filed on May 13, 2013, which is incorporated by reference, herein, in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to medical devices. More particularly, the present invention relates to a device and method for cardiac lead deployment.

BACKGROUND OF THE INVENTION

[0003] Current methods to guide leads into the heart for pacing do not allow for leads to be deployed in certain locations due to anatomic and imaging constraints. Although septal lead placement is desired in cardiac pacing, fluroscopy, which is routinely used to image the heart is often unhelpful to distinguish between septal and free wall lead placements.

[0004] Accordingly, there is a need in the art for a device and method for delivery and placement of septal leads at preferred locations in the right ventricle.

SUMMARY OF THE INVENTION

[0005] The foregoing needs are met, to a great extent, by a cardiac lead delivery device including a cardiac lead delivery device including a delivery catheter, having a proximal end and a distal end. The delivery catheter includes an outer wall defining in part a first lumen extending from the proximal end of the delivery catheter to the distal end of the delivery catheter. The delivery catheter also includes a second lumen defined in part by the outer wall of the delivery catheter extending from the proximal end of the delivery catheter to a point adjacent to a distal end of the delivery catheter. The device includes a guide wire configured to be passable through vasculature and chambers of the heart. The guide wire is configured to be disposed movably within the second lumen of the delivery catheter. A terminal deflectable portion of the delivery catheter is also included in the device and is positioned adjacent to a distal end of the delivery catheter, such that the guide wire deflects from the distal end of the delivery catheter. [0006] In accordance with an aspect of the present invention, the guidewire further includes a balloon at a distal tip of the guidewire. The delivery catheter further includes the outer wall defining an opening proximal to a distal end of the delivery catheter. The opening is in communication with the second lumen of the delivery catheter, such that when the guide wire is advanced through the second lumen it exits through the opening. The first lumen is configured for delivery of at least one electrical lead. The guide wire further takes the form of a shape memory metal. The delivery catheter further takes the form of a thermoplastic. The delivery catheter further includes a radiopaque marker. There is a predetermined angle between the guide wire and the delivery catheter at the terminal deflectable portion.

Alternately, there is an adjustable angle between the guide wire and the delivery catheter at the terminal deflectable portion.

[0007] In accordance with another aspect of the present invention, a method for delivery of a cardiac lead includes advancing a guide wire through vasculature to a desired position in a heart of a subject. The method includes threading a delivery catheter along the guide wire, such that the guide wire is at least partially disposed within a second lumen of the delivery catheter until the delivery catheter is in position for placement of the cardiac lead, and such that the guide wire is deflected from a terminal portion of the delivery catheter. The method also includes advancing the cardiac lead through a first lumen of the delivery catheter and placing the cardiac lead in the desired location. [0008] In accordance with yet another aspect of the present invention, the method includes inserting the guide wire into a right ventricular outflow tract (RVOT). The method includes deflecting the delivery catheter into the right ventricle. Additionally, the method includes visualizing the position of the delivery catheter using fluoroscopy and a radiopaque marker positioned on the delivery catheter. The method also includes advancing a first and a second cardiac lead through a first lumen of the delivery catheter. The method includes positioning the guide wire using a balloon disposed at a distal tip of the guide wire. The method includes using a guide wire and delivery catheter with a predetermined angle of deflection. Alternately, the method can include using a guide wire and delivery catheter with an adjustable angle of deflection. The method also includes exiting the guide wire from a second lumen of the catheter through an opening defined by an outer wall of the delivery catheter. In addition, the method includes exiting the guide wire from the second lumen just proximal to a distal end of the delivery catheter.

BRIEF DESCRIPTION OF THE DRAWING [0009] The accompanying drawings provide visual representations, which will be used to more fully describe the representative embodiments disclosed herein and can be used by those skilled in the art to better understand them and their inherent advantages. In these drawings, like reference numerals identify corresponding elements and:

[0010] FIG. 1 A illustrates a schematic diagram of a delivery catheter and guide wire, according to an embodiment of the present invention.

[0011] FIG. IB illustrates a sectional view of a delivery catheter taken adjacent to a proximal end of the delivery catheter, according to an embodiment of the present invention.

[0012] FIG. 1C illustrates a sectional view of a delivery catheter taken adjacent to a distal end of the delivery catheter, according to an embodiment of the present invention. [0013] FIG. ID illustrates a partial side view of the delivery catheter of FIG. 1A, according to an embodiment of the present invention.

[0014] FIG.2 illustrates a partial image of a heart of a subject with a diagram of a guide wire disposed in the right ventricular outflow tract, according to an embodiment of the present invention.

[0015] FIG. 3 illustrates a partial image of a heart of a subject with a diagram of a guide wire and associated delivery catheter, according to an embodiment of the present invention.

[0016] FIG. 4 illustrates a sectional view of a guide wire and associated delivery catheter superimposed over an image of the right ventricular outflow tract, according to an embodiment of the present invention.

[0017] FIG. 5 illustrates a partial view of a guide wire and associated delivery catheter superimposed over an image of the right ventricular outflow tract, according to an embodiment of the present invention.

[0018] FIG. 6 illustrates a partial view of a guide wire and associated delivery catheter superimposed over an image of the right ventricular outflow tract, according to an embodiment of the present invention.

[0019] FIG. 7 illustrates a flow diagram of a method of implanting cardiac leads, according to an embodiment of the present invention.

DETAILED DESCRIPTION

[0020] The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Drawings, in which some, but not all embodiments of the inventions are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains having the benefit of the teachings presented in the foregoing descriptions and the associated Drawings. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

[0021] An embodiment in accordance with the present invention provides a device and method for placing electrical leads in a desired location in the heart of a patient. A device of the present invention includes a guide wire that can be inserted through the vasculature and into a chamber of the heart near a desired location for electrical lead placement. A delivery catheter having a first lumen configured to accommodate at least one electrical lead for placement in the heart and a second lumen configured to accommodate the guide wire, is advanced over the guide wire to a position near that of the desired location for electrical lead placement. In this way, the electrical leads are delivered to the desired location. The guide wire can include a balloon tip for more accurate positioning and the catheter can include a terminal deflectable portion that deviates slightly from the path of the guide wire.

[0022] FIG. 1 A illustrates a schematic diagram of a delivery catheter and guide wire, according to an embodiment of the present invention. The delivery catheter 10 can take the form of an elongate tube having a proximal end 22 and a distal end 24 and can be formed from a thermoplastic elastomer or other biocompatible material. The delivery catheter 10 is configured to slide along a guide wire 12. The guide wire 12 can be disposed in the right ventricle outflow tract or in any other suitable position known to one of skill in the art, in order to deliver the lead placements to the desired position. The guide wire 12 can include a balloon tip at a distal end of the guide wire 12; however, the guide wire 12 can also be configured in any other way known to or conceivable by one of skill in the art. The guide wire 12 can be formed from a shape memory metal, such as NiTiNol and can be wrapped in a helical coil, straight or any other suitable configuration known to or conceivable by one of skill in the art.

[0023] The balloon tip is used to direct the guide wire 12 into the pulmonary artery and to enable the delivery catheter 10 to be advanced over the wire, but not past the distal end of the guide wire 12. As illustrated in FIG. 1A, the distal end of the delivery catheter 10 deviates from the line of the guide wire 12, referred to herein as a terminal deflectable portion, such that an outer wall 14 of the delivery catheter and the guide wire 12 form an angle of deflection. The angle can be predetermined or adjustable. The terminal deflectable portion directs the delivery catheter 10 away from the guide wire 12. The guide wire 12 exits the second lumen of the delivery catheter before the terminal deflectable portion through an opening in an outer wall 14 of the delivery catheter 10, as illustrated in FIG. ID, described below. The electrical lead(s) are introduced through the delivery catheter 10 and can be deployed anywhere in the heart along the guide wire 12, which acts as a support for the delivery catheter 10 to be held septally, while the guide wire 12 is in the pulmonary artery.

[0024] Note that a proximal end 22 of the delivery catheter 10 can take any form known to one of skill in the art. For instance, the proximal end 22 can include a hub and introducers for inserting the guide wire 12 and leads through the lumens of the delivery catheter 10. Each lumen can include a separate introducer sheath at the proximal end 22 of the delivery catheter 10.

[0025] FIG. IB illustrates a sectional view of a delivery catheter taken along axis A-A' of FIG. 1A, according to an embodiment of the present invention. As illustrated in FIG. IB, the delivery catheter 10 includes a first lumen 16 extending from the proximal end 22 to the distal end 24 of the delivery catheter 10 and a second lumen 18 also extending from the proximal end 22 to at least adjacent to the distal end 24 of the delivery catheter 10. The first lumen 16 is sized such that it can accommodate at least one electrical lead for placement in the heart. The second lumen 18 is sized such that the delivery catheter 10 can be moved proximally and distally along the guide wire 12, disposed at least partially within the second lumen 18 of the delivery catheter 10.

[0026] FIG. 1C illustrates a sectional view of a delivery catheter taken along axis B-B' of FIG. 1A, according to an embodiment of the present invention. As illustrated in FIG. 1C, the delivery catheter 10 can include a terminal deflectable portion, which creates a distance between the guide wire 12 and the distal end 24 of the delivery catheter 10. As noted above, the guide wire 12 exits the second lumen of the delivery catheter 10 before the terminal deflectable portion through an opening in an outer wall 14 of the delivery catheter 10.

[0027] FIG. ID illustrates a partial side view of the catheter between axis A-A' and B-B' according to the embodiment of the invention illustrated in FIG. 1A. Exit hole 20 is positioned on a side wall of the delivery catheter 10. Exit hole 20 is defined by a wall 14 of the elongate tube of the delivery catheter 10. Exit hole 20 is in communication with second lumen 18. When the guide wire 12 is advanced through second lumen 18, the guide wire 12 exits the delivery catheter at exit hole 20. After the guide wire 12 exits the exit hole 20, it deflects from a terminus of the delivery catheter 10, such that the guide wire 12 can be positioned in a pulmonary artery and the delivery catheter 10 is held septally. The delivery catheter 10 can be rotated to change the position of exit hole 20 to thereby change the direction of deflection of guide wire 12. The delivery catheter 10 can also include a radiopaque marker to indicate the position and orientation of the delivery catheter 10, using fluoroscopy.

[0028] FIG. 2 illustrates a partial image of a heart of a subject with a diagram of a guide wire disposed in the right ventricular outflow tract, according to an embodiment of the present invention. As illustrated in FIG. 2, the guide wire can be inserted into the right ventricular outflow tract (RVOT) in advance of insertion of the delivery catheter. Correct placement of the guide wire ensures that the delivery catheter can be positioned in such a way to deliver the leads to the preferred placement.

[0029] FIG. 3 illustrates a partial image of a heart of a subject with a diagram of a guide wire and associated delivery catheter, according to an embodiment of the present invention. As illustrated in FIG. 3, the delivery catheter is advanced along the guide wire into the RVOT. The wire is formed from a biocompatible material such that the delivery catheter can be advanced along it, while the guide wire holds its shape. However, the guide wire must also be flexible enough for insertion and advancement near delicate heart tissue. The catheter should be formed from a biocompatible plastic or other suitable material that is flexible enough to advance along the guide wire, along a potentially tortious path.

[0030] FIG. 4 illustrates a sectional view of a guide wire and associated delivery catheter superimposed over an image of the RVOT, according to an embodiment of the present invention. As illustrated in FIG. 4 the guide wire is disposed in the RVOT and the distal end of the sheath, marked by radiographically opaque material at least along a distal edge of the delivery catheter to allow for visualization on fluoroscopy.

[0031] FIG. 5 illustrates a partial view of a guide wire and associated delivery catheter superimposed over an image of the RVOT, according to an embodiment of the present invention. As illustrated in FIG. 5, the guide wire is disposed in the RVOT and the distal edge of the delivery catheter is marked by radiographically opaque material to allow visualization on fluoroscopy facing septally in the right ventricle.

[0032] FIG. 6 illustrates a partial view of a guide wire and associated delivery catheter superimposed over an image of the RVOT, according to an embodiment of the present invention. As illustrated in FIG. 6, the guide wire is disposed in the RVOT and the distal edge of the sheath is deflected septally in the right ventricle to allow for directing the electrical lead to the desired location.

[0033] FIG. 7 illustrates a flow diagram of method steps for placing electrical leads in the heart, according to an embodiment of the present invention. The method 100 includes a step 102 of advancing a guide wire through vasculature to a desired position in a heart of a subject. Step 104 includes threading a delivery catheter along the guide wire, such that the guide wire is at least partially disposed within a second lumen of the delivery catheter, until the delivery catheter is in position for placement of the cardiac lead. Step 104 also includes the guide wire being deflected from a terminal portion of the delivery catheter. Step 106 includes advancing the cardiac lead through a first lumen of the delivery catheter, and step 108 includes placing the cardiac lead in the desired position.

[0034] While the device is described with respect to lead placement in the right ventricle, through the RVOT, this device could be used for placement of electrical leads or other devices within any region of the heart or vasculature. The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

What is claimed is:

1. A cardiac lead delivery device comprising: a delivery catheter, having a proximal end and a distal end, wherein the delivery catheter includes an outer wall defining in part a first lumen extending from the proximal end of the delivery catheter to the distal end of the delivery catheter, and wherein the delivery catheter includes a second lumen defined in part by the outer wall of the delivery catheter extending from the proximal end of the delivery catheter to a point adjacent to a distal end of the delivery catheter; a guide wire configured to be passable through vasculature and chambers of the heart and wherein the guide wire is configured to be disposed movably within the second lumen of the delivery catheter; and a terminal deflectable portion of the delivery catheter positioned adjacent to a distal end of the delivery catheter, such that the guide wire deflects from the distal end of the delivery catheter.

2. The device of claim 1 wherein the guidewire further comprises a balloon at a distal tip of the guidewire.

3. The device of claim 1 wherein the delivery catheter further comprises the outer wall defining an opening proximal to a distal end of the delivery catheter.

4. The device of claim 3 wherein the opening is in communication with the second lumen of the delivery catheter, such that when the guide wire is advanced through the second lumen it exits through the opening.

5. The device of claim 1 wherein the first lumen is configured for delivery of at least one electrical lead.

6. The device of claim 1 wherein the guide wire further comprises a shape memory metal.

7. The device of claim 1 wherein the delivery catheter further comprises a thermoplastic.

8. The device of claim 1 wherein the delivery catheter further comprises a radiopaque marker.

9. The device of claim 1 wherein there is a predetermined angle between the guide wire and the delivery catheter at the terminal deflectable portion.

10. The device of claim lwherein there is an adjustable angle between the guide wire and the delivery catheter at the terminal deflectable portion.

11. A method for delivery of a cardiac lead comprising: advancing a guide wire through vasculature to a desired position in a heart of a subject; threading a delivery catheter along the guide wire, such that the guide wire is at least partially disposed within a second lumen of the delivery catheter until the delivery catheter is in position for placement of the cardiac lead, and such that the guide wire is deflected from a terminal portion of the delivery catheter; advancing the cardiac lead through a first lumen of the delivery catheter; and placing the cardiac lead in the desired location.

12. The method of claim 1 1 further comprising inserting the guide wire into a right ventricular outflow tract (RVOT).

13. The method of claim 1 1 further comprising deflecting the delivery catheter into the right ventricle.

14. The method of claim 1 1 further comprising visualizing the position of the delivery catheter using fluoroscopy and a radiopaque marker positioned on the delivery catheter.

15. The method of claim 1 1 further comprising advancing a first and a second cardiac lead through a first lumen of the delivery catheter.

16. The method of claim 1 1 further comprising positioning the guide wire using a balloon disposed at a distal tip of the guide wire.

17. The method of claim 1 1 further comprising using a guide wire and delivery catheter with a predetermined angle of deflection.

18. The method of claim 1 1 further comprising using a guide wire and delivery catheter with an adjustable angle of deflection.

19. The method of claim 1 1 further comprising exiting the guide wire from the second lumen of the catheter through an opening defined by an outer wall of the delivery catheter.

20. The method of claim 19 further comprising exiting the guide wire from the second lumen just proximal to a distal end of the delivery catheter.