WO2012071413A2

WO2012071413A2 - Assembly and method for coronary sinus cannulation

Info

Publication number: WO2012071413A2
Application number: PCT/US2011/061847
Authority: WO
Inventors: Alok Gambhir; John A. Vest
Original assignee: The Trustees Of Columbia University In The City Of New York
Priority date: 2010-11-23
Filing date: 2011-11-22
Publication date: 2012-05-31
Also published as: WO2012071413A3

Abstract

An anchored sheath platform assembly for coronary sinus cannulation is disclosed. In some embodiments, the assembly includes the following: an inferior vena cava anchor having a tapered distal end portion joined with a body portion; and an outer sheath having an open proximal end, a closed distal end, and a side port between the proximal and distal ends. The closed distal end is joined with the body portion of the inferior vena cava anchor. At least one of the inferior vena cava anchor and the outer sheath is sized so that the side port is automatically positioned and anatomically anchored in close proximity to the coronary sinus of a patient when the inferior vena cava anchor is first inserted in an inferior vena cava of the patient.

Description

ASSEMBLY AND METHOD FOR CORONARY SINUS CANNULATION

CROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Provisional Application No.

61/416,522, filed November 23, 2010, which is incorporated by reference as if disclosed herein in its entirety.

BACKGROUND

[0002] Heart failure is very common problem currently affecting over 5 million Americans and 23 million people worldwide. It is one of the leading causes of hospitalization for people over the age of 65 in the United States. The prevalence of heart failure increases with age, so this problem will only increase with the aging population in our country.

[0003] Cardiac resynchronization therapy (CRT) with biventricular pacing devices (including biventricular pacemakers and biventricular defibrillators) has been a major advancement in the treatment of advanced, medically refractory heart failure. The implantation of CRT devices is significantly more involved than the implantation of standard pacemakers due to the need to implant a third lead in the coronary sinus. These devices differ from conventional single and dual chamber pacing devices by adding an additional pacing lead, which is placed in a branch of the coronary sinus in order to allow for synchronous pacing of the right and left ventricles. The modification of

electromechanical delay resulting form this type of multi-site pacing can improve systolic function, reduce functional mitral regurgitation and in some cases induce favorable ventricular remodeling. As a result these devices can improve functional status, improve quality of life and reduce mortality. The indications for CRT devices have expanded considerably since this therapy was first introduced and are likely to continue expanding.

[0004] With currently available tools, cannulation of the coronary sinus can be a time-consuming process which increases patient risk, as it relies on operator maneuvers and sheath shape to locate the coronary sinus. Referring now to FIG. 1, with a conventional coronary sinus sheath, the operator first advances the sheath across the tricuspid valve (see large arrow). As the sheath is slowly withdrawn, counterclockwise torque is applied to the proximal end (see smaller angled arrows) in an effort to cause the sheath to move posteriorly towards the coronary sinus. By repeatedly performing this, or similar maneuvers, the operator searches for the coronary sinus. Conventional sheaths relay on the proprietary shape of the plastic sheath to optimize the chances that this motion will cause the sheath to cannulate the coronary sinus. Each manufacturer has unique proprietary shapes for coronary sinus sheaths. No available sheath design anatomically binds the sheath in proximity to the coronary sinus.

SUMMARY

[0005] Aspects of the disclosed subject matter include a sheath platform assembly to aid in cannulation of the coronary sinus, allowing for subsequent coronary sinus lead placement. In some embodiments, the sheath will consist of a distal end designed to extend well into the inferior vena cava and a more proximal side port through which a wire, additional sheath, pacing lead or any other necessary equipment can be passed. The extension of the sheath into the inferior vena cava will serve as an anchor that, by anatomical definition, will locate the side port in immediate proximity to the coronary sinus, thus increasing the ease with which the operator is able to cannulate the coronary sinus.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The drawings show embodiments of the disclosed subject matter for the purpose of illustrating the invention. However, it should be understood that the present application is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[0007] FIG. 1 is a schematic diagram of a conventional assembly according to the prior art, positioned within the heart of a patient; and [0008] FIG. 2 is a side section view of an assembly according to some embodiments of the disclosed subject matter;

[0009] FIG. 3 is a schematic diagram of an assembly according to embodiments of the disclosed subject matter, positioned within the heart of a patient; [0010] FIG. 4 is a side section view of an assembly according to some embodiments of the disclosed subject matter;

[0011] FIG. 5 is a schematic diagram of an assembly according to embodiments of the disclosed subject matter, positioned within the heart of a patient; and [0012] FIG. 6 is a chart of a method according to some embodiments of the disclosed subject matter.

DETAILED DESCRIPTION

[0013] Referring now to FIGS. 2-6, aspects of the disclosed subject matter include an assembly 100 for facilitating cannulation of a body 102 by automatically positioning and anatomically anchoring the assembly within the body. In some embodiments,

assembly 100 is used to facilitate cannulation of a coronary sinus 104 and the assembly is anchored within a cavity such as inferior vena cava 106. In some embodiments, assembly 100 includes a cavity anchor 108 joined with an outer sheath 110.

[0014] Referring now to FIGS. 2 and 3, cavity anchor 108 includes a distal end portion 111 joined with a body portion 112. Distal end portion 111 is typically tapered and formed from a yielding and compliant material to help prevent injury to the cavity. As one skilled in the art will appreciate, in some embodiments, distal end portion 111 may not be tapered and can include other configurations that allow for the distal end portion to be positioned within inferior vena cava 106. Body portion 112 is typically fabricated from a material capable of providing sufficient support for outer sheath 110 and other portions of assembly 100.

[0015] Outer sheath 110 includes proximal and distal ends 114 and 116, respectively, and a side port 118 positioned between the proximal and distal ends. Assembly 100 typically includes an outer sealing hub 120 for sealing proximal end 114 of outer sheath 110. Distal end 116 is joined with body portion 112 of cavity anchor 108. In some embodiments, assembly 100 includes a sealing hub 122 for joining distal end 116 of outer sheath 110 to body portion 112 of cavity anchor 108. [0016] In some embodiments, one or more components of assembly 100 may be adjustable in size, e.g., outer sheath 110 and cavity anchor 108 are joined via an adjustable threaded arrangement (not shown), body portion 112 of cavity anchor 108 is offered in various sizes, outer sheath 110 is offered in various sizes, and outer sheath 110 includes pre-defined knockout portions for defining the precise location of side port 118, etc.

[0017] At least one of cavity anchor 108 and outer sheath 110 are sized so that side port 118 is automatically positioned in close proximity to a particular area of the body, e.g., coronary sinus 104, when the cavity anchor is first inserted in a particular cavity, e.g., inferior vena cava 106. Cavity anchor 108 is configured so as to anatomically anchor assembly 100 in the body so that it remains in substantially the same position during use.

[0018] In some embodiments, assembly 100 includes an inner sheath 124 that is adapted to be inserted in proximal end 114 of outer sheath 110, through the outer sheath, and out of side port 118. In some embodiments, assembly 100 includes a wire 126 adapted to be inserted in proximal end 114 of outer sheath 110, through the outer sheath, out of side port 118, and into the area, e.g., coronary sinus 104.

[0019] Referring now to FIG. 3, in use, tapered distal end portion 111 of cavity anchor 108 is typically positioned so that it extends well into inferior vena cava 106. Inner sheath 124 is then passed through outer sheath 110 and out the more proximal side port 118. Equipment, e.g., wires, leads, balloons, etc., are then be passed through the guiding inner sheath 124 and into coronary sinus 104. Cavity anchor 108, by anatomic definition, keeps proximal side port 118 and guiding inner sheath 124 in close proximity to coronary sinus 104 thus simplifying the cannulation process.

[0020] Referring now to FIGS. 4 and 5, some embodiments include an assembly 200 for facilitating cannulation of a body 202 by automatically positioning and anatomically anchoring the assembly within the body. Assembly 200 is configured to be positioned within body 202 via a guidewire 203. In some embodiments, assembly 200 is used to facilitate cannulation of a coronary sinus 204 and the assembly is anchored within a cavity such as inferior vena cava 206. In some embodiments, assembly 200 includes a cavity anchor 208 joined with an outer sheath 210. [0021] Referring now to FIGS. 2 and 3, cavity anchor 208 includes a distal end portion 211 joined with a body portion 212. Distal end portion 211 is typically tapered and formed from a yielding and compliant material to help prevent injury to the cavity. As one skilled in the art will appreciate, in some embodiments, distal end portion 211 not be tapered and can include other configurations that allow for the distal end portion to be positioned within inferior vena cava 206. Body portion 212 is typically fabricated from a material capable of providing sufficient support for outer sheath 210 and other portions of assembly 200. Cavity anchor 208 includes a guidewire channel 213 that extend through distal end portion 211 and body portion 212 and is in fluid communication with outer sheath 210.

[0022] Outer sheath 210 includes proximal and distal ends 214 and 216, respectively, and a side port 218 positioned between the proximal and distal ends. Assembly 200 typically includes an outer sealing hub 220 for sealing proximal end 214 of outer sheath 210. Distal end 216 is joined with body portion 212 of cavity anchor 208. In some embodiments, assembly 200 includes a sealing hub 222 for joining distal end 216 of outer sheath 210 to body portion 212 of cavity anchor 208. In some embodiments sealing hub 222 also seals guidewire channel 213.

[0023] In some embodiments, one or more components of assembly 200 may be adjustable in size, e.g., outer sheath 210 and cavity anchor 208 are joined via an adjustable threaded arrangement (not shown), body portion 212 of cavity anchor 208 is offered in various sizes, outer sheath 210 is offered in various sizes, and outer sheath 210 includes pre-defined knockout portions for defining the precise location of side port 218, etc.

[0024] At least one of cavity anchor 208 and outer sheath 210 are sized so that side port 218 is automatically positioned in close proximity to a particular area of the body, e.g., coronary sinus 204, when the cavity anchor is first inserted in a particular cavity, e.g., inferior vena cava 206. Cavity anchor 208 is configured so as to anatomically anchor assembly 200 in the body so that it remains in substantially the same position during use.

[0025] In some embodiments, assembly 200 includes an inner sheath 224 that is adapted to be inserted in proximal end 214 of outer sheath 210, through the outer sheath, and out of side port 218. In some embodiments, assembly 200 includes a wire 226 adapted to be inserted in proximal end 214 of outer sheath 210, through the outer sheath, out of side port 218, and into the area, e.g., coronary sinus 204.

[0026] Referring now to FIG. 3, in use, guidewire 203 is inserted through outer sheath 210 and guidewire channel 213 of cavity anchor 208 so that it extends from tapered distal end portion 211 of the cavity anchor. Guidewire 203 is inserted into inferior vena cava 206 and used to position tapered distal end portion 211 of cavity anchor 208 so that it extends well into the inferior vena cava. After cavity anchor 208 is properly positioned within inferior vena cava 206, guidewire 203 is removed from assembly 200. Then, inner sheath 224 is then passed through outer sheath 210 and out the more proximal side port 218. Equipment, e.g., wires, leads, balloons, etc., are then be passed through the guiding inner sheath 224 and into coronary sinus 204. Cavity anchor 208, by anatomic definition, keeps proximal side port 218 and guiding inner sheath 224 in close proximity to coronary sinus 204 thus simplifying the cannulation process. [0027] Referring now to FIG. 6, some embodiments include a method 300 of cannulating a coronary sinus. At 302, an anchored sheath platform assembly including an inferior vena cava anchor joined with an outer sheath having a side port is provided. In some embodiments, the inferior vena cava anchor includes a body portion that is fabricated from a material capable of providing sufficient support for the outer and inner sheaths and a tapered distal end portion that is formed from a yielding and compliant material to help prevent injury to the patient. At 304, the inferior vena cava anchor is inserted into an inferior vena cava of a patient. In some embodiments, a guidewire is first inserted through the anchored sheath platform assembly and into the inferior vena cava of a patient. The guidewire is used to guide the inferior vena cava anchor into the inferior vena cava and is removed after the anchor is properly positioned within the patient. At 306, a wire is inserted through the outer sheath and the side port and into the coronary sinus of the patient. Referring again to 302 and 304, for the anchored sheath platform assembly, at least one of the inferior vena cava anchor and the outer sheath are sized so that the side port is automatically positioned and anatomically anchored in close proximity to the coronary sinus of the patient when the inferior vena cava anchor is first inserted in the inferior vena cava of the patient. In some embodiments, at 308, an inner sheath is inserted in the outer sheath, through the outer sheath, and out of the side port.

[0028] Embodiments of the disclosed subject matter include a novel sheath platform to aid in the cannulation of the coronary sinus, allowing for easier coronary sinus lead placement. The sheath consists of a distal end designed to extend well into the inferior vena cava and a more proximal side port through which a wire, additional sheath, pacing lead or any other necessary equipment can be passed. The extension of the sheath into the inferior vena cava will serve as an anchor that, by anatomical definition, will locate the side port in immediate proximity to the coronary sinus. [0029] Although the disclosed subject matter has been described and illustrated with respect to embodiments thereof, it should be understood by those skilled in the art that features of the disclosed embodiments can be combined, rearranged, etc., to produce additional embodiments within the scope of the invention, and that various other changes, omissions, and additions may be made therein and thereto, without parting from the spirit and scope of the present invention.

Claims

CLAIMS What is claimed is:

1. An assembly for facilitating cannulation of a body, said assembly comprising:

a cavity anchor having a distal end portion joined with a body portion; and an outer sheath having proximal and distal ends and a side port between said proximal and distal ends, said distal end being joined with said body portion of said cavity anchor;

wherein at least one of said cavity anchor and said outer sheath are sized so that said side port is automatically positioned in close proximity to a particular area of said body when said cavity anchor is first inserted in a particular cavity of said body that is adjacent said particular area and wherein said cavity anchor is configured so as to anatomically anchor said assembly in said body.

2. The assembly of claim 1, wherein said cavity is an inferior vena cava and said area is a coronary sinus.

3. The assembly of claim 1, further comprising an outer sealing hub for sealing said

proximal end of said outer sheath.

4. The assembly of claim 1, further comprising a sealing hub for joining said distal end of said outer sheath to said body portion of said cavity anchor.

5. The assembly of claim 1, further comprising an inner sheath adapted to be inserted in said proximal end of said outer sheath, through said outer sheath, and out of said side port.

6. The assembly of claim 5, wherein said body portion of said cavity anchor is fabricated from a material capable of providing sufficient support for said outer and inner sheaths.

7. The assembly of claim 1, further comprising a wire adapted to be inserted in said

proximal end of said outer sheath, through said outer sheath, out of said side port, and into said area.

8. The assembly of claim 1, wherein said distal end portion of said cavity anchor is tapered and formed from a yielding and compliant material to help prevent injury to said cavity.

9. The assembly of claim 1, wherein said cavity anchor and said outer sheath are joined via an adjustable threaded connection.

10. An anchored sheath platform assembly for coronary sinus cannulation, said assembly comprising:

an inferior vena cava anchor having a tapered distal end portion joined with a body portion; and

an outer sheath having an open proximal end, a closed distal end, and a side port between said proximal and distal ends, said closed distal being joined with said body portion of said inferior vena cava anchor;

wherein at least one of said inferior vena cava anchor and said outer sheath are sized so that said side port is automatically positioned and anatomically anchored in close proximity to said coronary sinus of a patient when said inferior vena cava anchor is first inserted in an inferior vena cava of said patient.

11. The assembly of claim 10, further comprising an outer sealing hub for sealing said open proximal end of said outer sheath.

12. The assembly of claim 10, further comprising a guidewire channel formed through said tapered distal end portion and said body portion of said anchor, wherein said guidewire channel is in fluid communication with said outer sheath.

13. The assembly of claim 12, further comprising a sealing hub for joining said distal end of said outer sheath to said body portion of said cavity anchor.

14. The assembly of claim 10, further comprising an inner sheath adapted to be inserted in said open proximal end of said outer sheath, through said outer sheath, and out of said side port.

15. The assembly of claim 10, further comprising a wire adapted to be inserted in said open proximal end of said outer sheath, through said outer sheath, out of said side port, and into said coronary sinus.

16. The assembly of claim 10, wherein said body portion of said inferior vena cava anchor is fabricated from a material capable of providing sufficient support for the outer and inner sheaths.

17. The assembly of claim 10, wherein said tapered distal end portion of said inferior vena cava anchor is formed from a yielding and compliant material to help prevent injury to said patient.

18. A method of cannulating a coronary sinus, said method comprising:

providing an anchored sheath platform assembly including an inferior vena cava anchor joined with an outer sheath having a side port;

inserting said inferior vena cava anchor into an inferior vena cava of a patient; and inserting a wire through said outer sheath and said side port and into said coronary sinus of said patient;

wherein at least one of said inferior vena cava anchor and said outer sheath are sized so that said side port is automatically positioned and anatomically anchored in close proximity to said coronary sinus of said patient when said inferior vena cava anchor is first inserted in said inferior vena cava of said patient.

19. The method of claim 18, further comprising:

inserting an inner sheath in said outer sheath, through said outer sheath, and out of said side port.

20. The method of claim 18, wherein said inferior vena cava anchor includes a tapered distal end portion that is formed from a yielding and compliant material to help prevent injury to said patient.