DEPLOYABLE SENSOR PLATFORM ON THE LEAD SYSTEM OF AN IMPLANTABLE DEVICE

• US 20100210923A1
• Filed: 01/12/2010
• Published: 08/19/2010
• Est. Priority Date: 02/13/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Acuna, Andrea, Tockman, Bruce A., Li, Dan, Shuros, Allan C.
• Granted Patent: US 8,694,129 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Systems and methods for deploying a sensor assembly onto a cardiac lead are disclosed. The sensor assembly can include a resilient cuff having one or more sensor modules for sensing physiological parameters within the body. The resilient cuff may have a substantially cylindrical shape having an inner diameter that is smaller than an outer diameter of the lead body onto which the cuff is deployed such that the cuff is retained on the lead body by frictional forces. The sensor assembly may be deployed in conjunction with a new lead to be implanted within a chamber of the patient'"'"'s heart or a body vessel, or may be deployed onto an existing, implanted lead implanted within the patient'"'"'s body.

Claims

1. A medical electrical lead, comprising:

a lead body having a proximal section and a distal section, the proximal section of the lead body adapted to connect to a pulse generator;

at least one electrical conductor extending within the lead body;

at least one electrode located on the lead body and operatively coupled to the at least one electrical conductor;

a resilient cuff frictionally engaged on an outer surface of the lead body; and

at least one sensor module coupled to the cuff and including a sensor adapted to detect at least one physiological parameter.

2. The lead according to claim 1, wherein the sensor module further comprises an electrical conductor adapted to connect to the pulse generator.

3. The lead according to claim 1, wherein the sensor is a wireless sensor and is adapted to communicate wirelessly to an external device.

4. The lead according to claim 1, wherein the sensor is a wireless sensor and is adapted to communicate wirelessly with a pulse generator.

5. The lead according to claim 1, wherein the at least one physiological parameter is selected from the group of parameters including blood pressure, temperature, blood gas content, strain, or fluid flow.

6. The lead according to claim 1, wherein the at least one physiological parameter includes blood pressure.

7. The lead according to claim 1, wherein the sensor module comprises a first sensor adapted to detect a first physiological parameter and a second sensor adapted to detect a second physiological parameter.

8. The lead according to claim 1, wherein the cuff includes a slit extending from a first end of the cuff to a second end of the cuff, the slit comprising a width W smaller than an outer diameter of the lead body, the slit configured to expand such that the cuff width increases to a size sufficient to receive the lead body within an interior section of the cuff.

9. The lead according to claim 1, wherein an inner diameter of the cuff is smaller than an outer diameter of the lead body.

10. The lead according to claim 1, wherein the cuff comprises a shape memory material.

11. A system for deploying a sensor assembly onto a medical electrical lead, the system comprising:

a delivery catheter including a lumen adapted to receive the medical electrical lead;

a sensor assembly coupled to an outer surface of the delivery catheter, the sensor assembly including a resilient cuff and at least one sensor module adapted to detect a physiological parameter; and

a deployment member slideably disposed over an outer surface of the delivery catheter and located proximal to the sensor assembly.

12. The system according to claim 11, further comprising an outer catheter having an interior lumen, wherein the delivery catheter including the sensor assembly coupled thereto and the deployment member are slideable within the interior lumen of the outer catheter.

13. The system according to claim 11, wherein the deployment member comprises a hypotube.

14. The system according to claim 11, wherein the cuff includes a slit extending from a first end of the cuff to a second end of the cuff, the slit comprising a width W smaller than an outer diameter of the lead body, the slit configured to expand such that the cuff width increases to a size sufficient to receive the lead body within an interior section of the cuff.

15. The system according to claim 11, wherein the at least one physiological parameter selected from the group of parameters including blood pressure, temperature, blood gas content, strain, or fluid flow.

16. The system according to claim 11, wherein the at least one physiological parameter includes blood pressure.

17. A method of coupling a sensor to an implantable medical electrical lead, the method comprising:

guiding a sensor assembly deployment system to a location within a patient'"'"'s body, the sensor assembly comprising;

a delivery catheter having an interior lumen through which a medial electrical lead can be delivered;

a sensor assembly coupled to an outer surface of the delivery catheter, the sensor assembly including a resilient cuff and at least one sensor module; and

a deployment member slideably disposed over an outer surface of the delivery catheter and located proximal to the sensor assembly;

delivering a medical electrical lead through the interior lumen of the delivery catheter to a target location within the heart or body vessel, the lead comprising a lead body having a proximal section adapted to connect to a pulse generator, at least one electrical conductor extending within the lead body, and at least one electrode operatively connected to the at least one electrical conductor;

positioning the lead at the target location within the heart or body vessel; and

actuating the deployment member to deploy the sensor assembly from the inner catheter and onto an outer surface of the lead body, wherein the sensor assembly is configured to frictionally engage the outer surface of the lead body.

18. The method according to claim 17, wherein the step of actuating the deployment member comprises moving the deployment member in a distal direction to push the sensor assembly off of the outer surface of the delivery catheter and onto an outer surface of the lead body.

19. The method according to claim 17, wherein the step of actuating the deployment member comprises holding the sensor assembly stationary relative to the delivery catheter and pulling the delivery catheter in a proximal direction to deploy the sensor assembly off of the outer surface of the delivery catheter and onto an outer surface of the lead body.

20. The method according to claim 17, further comprising moving the inner catheter in a distal or a proximal direction to position the sensor module at a desired location for sensing.