Kit and method for installation of a probe implantable in the coronary network for stimulation of a cardiac cavity

• US 6,625,496 B1
• Filed: 05/14/2001
• Issued: 09/23/2003
• Est. Priority Date: 05/16/2000
• Status: Expired due to Term

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Ollivier, Jean-Francois
• Primary Examiner(s): Evanisko, George R.
• Assistant Examiner(s): KHAN, OMAR A
• Application Number:
  US09/854,542
• Time in Patent Office: 862 Days
• Field of Search: 607/115, 607/122-131, 607/37
• US Class Current: 607/122
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A method and kit for the installation of a probe, implantable in the coronary sinus network for stimulation of a cardiac cavity. The kit includes: a) a guiding catheter (14), having an internal lumen open at its two extremities and able to receive the probe (10) along its length; and b) an extension (22) comprising at its distal extremity a connector (24) engaging a monodiameter connector (20) at the proximal extremity of the probe (10). The external diameter of the connector (24) is the external diameter of the remainder of the extension (22). The external surface of the extension (22) is a surface having a low coefficient of friction as compared to the interior surface of the lumen of the guiding-catheter (14), and the external diameter is smaller than the interior diameter of the lumen of the guiding-catheter, so as to allow the guiding catheter to slide over and along the entire length of the extension, without a concomitant axial displacement of the probe. Preferably, the guiding catheter has a sufficient rigidity in torsion to allow the transmission of a rotational movement imparted at one extremity to the other extremity, and also has an increased flexibility in the vicinity of its distal extremity.

Claims

1. A kit for installing a probe implantable in the coronary network for stimulation of a cardiac cavity, said kit comprising:

a) a probe comprising a length, a proximal extremity, and a monodiameter connector at said proximal extremity;

b) a guiding catheter comprising an internal lumen, said internal lumen having an interior diameter, an interior surface having a coefficient of friction, a first open extremity and a second open extremity and a length dimension, and

c) an extension having a proximal extremity and a distal extremity, an internal lumen, an external diameter that is less than the interior diameter of the lumen of the guiding catheter, an external surface comprising a coefficient of friction that is lower than the coefficient of friction of the interior surface of the lumen of the guiding catheter, and a connector at the distal extremity to connect the extension distal extremity to the monodiameter connector of the probe without insertion into the monodiameter connector of the probe, the monodiameter connector having an external diameter that is substantially the same as the external diameter of the extension, wherein the guiding catheter is slideable along the entire length of the extension without a concomitant axial displacement of the probe connected to said extension.

2. The kit of claim 1, further comprising a stylet having a length and a proximal extremity, said stylet able to be inserted in the internal lumen of the extension, the stylet length being greater than a sum of the lengths of the probe to be installed and the extension.

3. The kit of claim 1, further comprising a sleeve able to be encased on the monodiameter connector of the probe to form a plug for electric connection to a connector head of a pacemaker or a defibrillator.

4. The kit of claim 3, wherein said probe further comprises an internal lumen having a proximal extremity, and wherein said kit further comprises a stylet having a length sufficient to be inserted in said sleeve and said proximal extremity of said internal lumen of said probe.

5. The kit of claim 4, further comprising a tool for placement of the sleeve, said tool comprising a distal housing able to receive said stylet, and said stylet able to be threaded on the proximal extremity of the probe monodiameter connector.

6. The kit of claim 5, wherein said tool further comprises a depth gauge able to adjust a depth (d) of axial penetration of the sleeve on the proximal extremity of the probe monodiameter connector.

7. The kit of claim 3, wherein said sleeve further comprises a set of dimensions in conformity with the connection system standard IS-1.

8. The kit of claim 1, further comprising:

c) a stylet having a length and a proximal extremity, able to be inserted in the internal lumen of the extension, the stylet length being greater than a sum of the lengths of the probe and the extension.

9. The kit of claim 8 further comprising a sleeve able to be encased on the monodiameter connector of the probe to form a plug for electric connection to a connector head of a pacemaker or a defibrillator.

10. A method for installing a probe implantable in the coronary network for stimulation of a cardiac cavity, said method comprising:

a) providing a probe having a length, a proximal extremity, and a monodiameter connector at said proximal extremity;

b) providing a guiding catheter having an internal lumen, said internal lumen including an interior diameter, an interior surface and a coefficient of friction, a first open extremity and a second open extremity and a first length;

c) providing an extension having a proximal extremity and a distal extremity, an internal lumen, an external diameter that is less than the interior diameter of the lumen of the guiding catheter, an external surface comprising a coefficient of friction that is lower than the coefficient of friction of the interior surface of the lumen of the guiding-catheter, and a connector at the distal extremity to connect the extension distal extremity to the monodiameter connector of the probe without insertion into the monodiameter connector of the probe, the connector having an external diameter that is substantially the same as the external diameter of the extension, wherein the guiding catheter is slideable along the entire length of the extension without a concomitant axial displacement of the probe connected to said extension;

d) inserting the guiding catheter in the coronary sinus network;

e) inserting the probe in the guiding catheter to install said probe in said coronary sinus network;

f) connecting the extension to the proximal end of the probe;

g) removing the guiding catheter from said patient while maintaining the probe in its installed position; and

h) disconnecting the extension from said probe.

11. The method of claim 10, further comprising providing a sleeve able to be encased on the monodiameter connector of the probe to form a plug for electric connection to a connector head of pacemaker or defibrillator, the method further comprising:

i) installing the sleeve on said monodiameter connector.

12. The method of claim 11, further comprising providing a stylet having a length sufficient to be inserted in said sleeve and the proximal extremity of said probe internal lumen, and wherein step i) further comprises installing said stylet in said sleeve and in said monodiameter connector.

13. The method of claim 12, further comprising providing a tool for placement of the sleeve, said tool comprising a distal housing able to receive said stylet, and said stylet able to be threaded on the proximal extremity of the probe monodiameter connector.

14. The method of claim 10, further comprising providing a stylet having a length greater than a sum of the lengths of the probe to be installed and the extension, and, after step f) and before step g), the method further comprises inserting the stylet in the internal lumen of the to extension and the probe.

15. A kit for installing a probe implantable in the coronary network for stimulation of a cardiac cavity said kit comprising:

a) a probe comprising a length, a proximal extremity, a monodiameter connector at said proximal extremity, and an internal lumen having a proximal extremity;

b) a guiding catheter comprising an internal lumen, said internal lumen having an interior diameter, an interior surface having a coefficient of friction, a first open extremity and a second open extremity and a length dimension, and

c) an extension having a proximal extremity and a distal extremity, an internal lumen, an external diameter that is less than the interior diameter of the lumen of the guiding catheter, an external surface comprising a coefficient of friction that is lower than the coefficient of friction of the interior diameter of the lumen of the guiding catheter, and a connector at the distal extremity to connect the extension distal extremity to the monodiameter connector of the probe, the monodiameter connector having an external diameter that is substantially the same as the external diameter of the extension, wherein the guiding catheter is slideable along the entire length of the extension without a concomitant axial displacement of the probe connected to said extension;

d) a sleeve able to be encased on the monodiameter connector of the probe to form a plug for electric connection to a connector head of a pacemaker or a defibrillator;

e) a stylet having a length sufficient to be inserted in said sleeve and said proximal extremity of said internal lumen of said probe; and

e) a tool for placement of the sleeve, said tool comprising a distal housing able to receive said stylet and said stylet able to be threaded on the proximal extremity of the probe monodiameter connector.

16. The kit of claim 15, wherein said tool further comprises a depth gauge able to adjust a depth (d) of axial penetration of the sleeve on the proximal extremity of the probe monodiameter connector.

17. A method for installing a probe implantable in the coronary network for stimulation of a cardiac cavity, said method comprising:

a) providing a probe having a length, a proximal extremity, and a monodiameter connector at said proximal extremity;

b) providing a guiding catheter having an internal lumen, said internal lumen including an interior diameter, and interior surface and a coefficient of friction, a first open extremity and a second open extremity and a first length;

c) providing an extension having a proximal extremity and a distal extremity, an internal lumen, an external diameter that is less than the interior diameter of the lumen of the guiding catheter, an external surface comprising a coefficient of friction that is lower than the coefficient of friction of the interior surface of the lumen of the guiding catheter, and a connector at the distal extremity to connect the extension distal extremity to the monodiameter connector of the probe, the connector having an external diameter that is substantially the same as the external diameter of the extension, wherein the guiding catheter is slideable along the entire length of the extension without a concomitant axial displacement of the probe connected to said extension;

d) inserting the guiding catheter in the coronary sinus network;

e) inserting the probe in the guiding catheter to install said probe in said coronary sinus network;

f) connecting the extension to the proximal end of the probe;

g) removing the guiding catheter from said patient while maintaining the probe in its installed position;

h) disconnecting the extension from said probe;

i) providing a sleeve able to be encased on the monodiameter connector of the probe to form a plug for electric connection to a connector head of pacemaker or defibrillator;

j) installing the sleeve on said monodiameter connector;

k) providing a stylet having a length sufficient to be inserted in said sleeve and the proximal extremity of said probe internal lumen;

l) installing said stylet in said sleeve and in said monodiameter connector; and

m) providing a tool for placement of the sleeve, said tool comprising a distal housing able to receive said stylet, and said stylet able to be threaded on the proximal extremity of the probe monodiameter connector.