PACING SYSTEM FOR USE DURING CARDIAC CATHETERIZATION OR SURGERY

• US 20100056858A1
• Filed: 08/25/2009
• Published: 03/04/2010
• Est. Priority Date: 09/02/2008
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mokelke, Eric A., Shuros, Allan C.
• Application Number:
  US12/547,316
• Publication Number:
  US 20100056858A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Cardioprotective pacing is applied to prevent and/or reduce cardiac injury associated with cardiac catheterization or surgery. Pacing pulses are generated from a pacemaker and delivered through one or more pacing electrodes incorporated onto one or more devices used in the cardiac catheterization or surgery. The pacemaker controls the delivery of the pacing pulses by executing a cardioprotective pacing protocol. In one embodiment, the one or more pacing electrodes are incorporated onto an intravascular ultrasound (IVUS) catheter. In another embodiment, the one or more pacing electrodes are incorporated onto one or more cardiac surgical instruments such as a heart stabilizer and a sternal retractor.

Claims

1. A pacing system for use during a percutaneous transluminal vascular intervention (PTVI) procedure, the system comprising:

an intravascular ultrasound (IVUS) catheter being a PTVI device including a proximal end portion, a distal end portion, and an elongate shaft connected between the proximal end portion and the distal end portion, the distal end portion configured for intravascular placement and including;

an ultrasonic transducer configured to transmit an ultrasound signal and receive an image signal related to the transmitted ultrasound signal; and

a first pacing electrode configured to deliver pacing pulses.

2. The system of claim 1, comprising an external device including:

a pullback motor;

an external pacemaker; and

a chassis housing the pullback motor and the external pacemaker,

and wherein the proximal end portion of the IVUS catheter comprises a catheter connector including one or more connectors configured to provide connections each between the IVUS catheter and one of the pullback motor and the external pacemaker.

3. The system of claim 1, comprising:

a pacing output circuit configured to be connected to the proximal end portion of the IVUS catheter and deliver the pacing pulses to the first pacing electrode;

a pacing control circuit configured to control the delivery of the pacing pulses by automatically executing a cardioprotective pacing protocol specifying pacing parameters selected to augment cardiac mechanical stress to a level effecting cardioprotection against myocardial injury using the pacing pulses; and

a pacing protocol module coupled to the pacing control circuit, the pacing protocol module containing machine-readable instructions for automatically executing the cardioprotective pacing protocol.

4. The system of claim 3, comprising an external pacemaker including:

a pacemaker chassis housing the pacing output circuit and the pacing control circuit; and

a pacing protocol interface incorporated onto the chassis and configured to receive the machine-readable instructions from the pacing protocol module,

and wherein the pacing protocol module is configured to be externally attached to the external pacemaker and electrically connected to the pacing protocol interface.

5. The system of claim 3, wherein the distal end portion of the IVUS catheter comprises a second pacing electrode configured to allow the pacing pulses to be delivered using the first pacing electrode and the second pacing electrode.

6. The system of claim 3, comprising a body-surface electrode configured to be electrically connected to the pacing output circuit to allow the pacing pulses to be delivered using the first pacing electrode and the body-surface electrode.

7. The system of claim 3, comprising a further PTVI device other than the IVUS catheter, the further PTVI device configured to be electrically connected to the pacing output circuit and including a second pacing electrode configured to allow the pacing pulses to be delivered using the first pacing electrode and the second pacing electrode.

8. A method for cardiac pacing during a percutaneous transluminal vascular intervention (PTVI) procedure, the method comprising:

providing an intravascular ultrasound (IVUS) catheter being a PTVI device including a distal end portion configured for intravascular placement, the distal end portion including an ultrasonic transducer and a first pacing electrode; and

delivering pacing pulses through the first pacing electrode during the PTVI procedure.

9. The method of claim 8, comprising controlling the delivery of the pacing pulses by automatically executing a pacing protocol using an external pacemaker connected to the IVUS catheter.

10. The method of claim 9, wherein automatically executing the pacing protocol comprises automatically executing a cardioprotective pacing protocol adapted to augment cardiac mechanical stress to a level effecting cardioprotection against myocardial injury using the pacing pulses, the cardioprotective pacing protocol specifying a cardiac protection pacing sequence including alternating pacing and non-pacing periods, the pacing periods each having a pacing duration during which a plurality of the pacing pulses is delivered, the non-pacing periods each having a non-pacing duration during which none of the pacing pulses is delivered.

11. The method of claim 10, comprising providing the cardioprotective pacing protocol specifying a number of cycles of the alternating pacing and non-pacing periods between 1 and 4 cycles, the pacing duration between 10 seconds and 20 minutes, and the non-pacing duration between 10 seconds and 20 minutes.

12. The method of claim 11, comprising initiating the delivery of the pacing pulses by automatically executing the cardioprotective pacing protocol in response to an indication of reperfusion during the PTVI procedure.

13. A pacing system for use during a cardiac surgery performed on or about a heart, the system comprising:

a heart stabilizer including;

a suction cup configured to hold the heart using vacuum suction and including a first pacing electrode configured to deliver pacing pulses to the heart; and

a positioning arm including a distal end connected to the suction cup, a proximal end including a positioning handle, and an elongate positioning shaft connected between the distal end and the proximal end, the positioning handle configured to allow a user to manipulate the position of the suction cup by adjusting the shape of the positioning shaft.

14. The system of claim 13, wherein the suction cup comprises a plurality of pacing electrodes to deliver the pacing pulses, the plurality of pacing electrodes including the first pacing electrode.

15. The system of claim 14, wherein the suction cup comprises a multi-appendage suction cup including a plurality of appendages, and the plurality of pacing electrodes comprises pacing electrodes incorporated onto one or more appendages of the plurality of appendages.

16. The system of claim 14, wherein the suction cup comprises an array of small suction cups, and the plurality of pacing electrodes comprises pacing electrodes incorporated onto one or more small suction cups of the array of small suction cups.

17. The system of claim 13, comprising a sternal retractor including a second pacing electrode configured to allow the pacing pulses to be delivered through the first pacing electrode and the second pacing electrode, and wherein the heart stabilizer comprises a base connected to the positioning shaft and configured to be clamped on the sternal retractor.

18. The system of claim 13, comprising:

a pacing output circuit configured to be connected to the heart stabilizer and deliver the pacing pulses to the first pacing electrode;

a pacing control circuit configured to control the delivery of the pacing pulses by automatically executing a cardioprotective pacing protocol specifying pacing parameters selected to augment cardiac mechanical stress to a level effecting cardioprotection against myocardial injury using the pacing pulses; and

a pacing protocol module coupled to the pacing control circuit, the pacing protocol module containing machine-readable instructions for automatically executing the cardioprotective pacing protocol.

19. The system of claim 18, comprising an external pacemaker including:

a pacemaker chassis housing the pacing output circuit and the pacing control circuit; and

a pacing protocol interface incorporated onto the chassis and configured to receive the machine-readable instructions from the pacing protocol module,

and wherein the pacing protocol module is configured to be externally attached to the external pacemaker and electrically connected to the pacing protocol interface.

20. A method for cardiac pacing during cardiac surgery, the method comprising:

providing a heart stabilizer including a suction cup configured to hold the heart using vacuum suction and including a first pacing electrode; and

delivering pacing pulses through the first pacing electrode.

21. The method of claim 20, comprising:

providing a sternal retractor including a second pacing electrode; and

delivering the pacing pulses through the first pacing electrode and the second pacing electrode.

22. The method of claim 20, comprising controlling the delivery of the pacing pulses by automatically executing a pacing protocol using an external pacemaker connected to the heart stabilizer.

23. The method of claim 22, wherein automatically executing the pacing protocol comprises automatically executing a cardioprotective pacing protocol adapted to augment cardiac mechanical stress to a level effecting cardioprotection against myocardial injury using the pacing pulses, the cardioprotective pacing protocol specifying a cardiac protection pacing sequence including alternating pacing and non-pacing periods, the pacing periods each having a pacing duration during which a plurality of the pacing pulses is delivered, the non-pacing periods each having a non-pacing duration during which none of the pacing pulses is delivered.

24. The method of claim 23, comprising providing the cardioprotective pacing protocol specifying a number of cycles of the alternating pacing and non-pacing periods between 1 and 4 cycles, the pacing duration between 10 seconds and 20 minutes, and the non-pacing duration between 10 seconds and 20 minutes.

25. The method of claim 24, comprising initiating the delivery of the pacing pulses by automatically executing the cardioprotective pacing protocol in response to an indication of reperfusion during the cardiac surgery.