Delivery system for implantable biostimulator

• US 20070088418A1
• Filed: 10/13/2006
• Published: 04/19/2007
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Nanostim, Inc (Abbott Laboratories Incorporated)
• Inventors: Jacobson, Peter
• Granted Patent: US 8,010,209 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: A61N 1/37518 : Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3925 : Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 : Pacing therapy
• CPC Class Codes: A61N 2001/058 : Fixing tools
• CPC Class Codes: H04B 13/005 : Transmission systems in which the medium consists of the human body

Abstract

A delivery system for implanting a biostimulation device comprising a stylet extending along an axis from knob end to a threaded end configured to engage an internally threaded nut of the biostimulation device and a catheter tube configured to axially contain the stylet. The catheter tube comprises a feature that engages a corresponding feature on the biostimulation device whereby the stylet can be rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end.

Claims

1. A delivery system configured for implanting a biostimulation device comprising:

a stylet extending along an axis from knob end to a threaded end configured to engage an internally threaded nut of the biostimulation device; and

a catheter tube configured to axially contain the stylet, the catheter tube comprising a feature that engages a corresponding feature on the biostimulation device whereby the stylet can be rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end.

2. The system according to claim 1 further comprising:

a sliding sheath assembly configured to axially slide over the stylet and engaged biostimulation device, the sliding sheath assembly comprising a feature that engages a corresponding feature on the biostimulation device whereby the stylet can be rotated relative to the sliding sheath for disengagement of the stylet threaded end from the biostimulation device threaded end.

3. The system according to claim 2 further comprising:

the sliding sheath configured to protect patient tissue from damage during insertion of the biostimulation device.

4. The system according to claim 2 further comprising:

the sliding sheath further comprising a feature configured to engage and rotate the biostimulation device and affix a fixation member coupled to the biostimulation device into patient tissue.

5. The system according to claim 2 further comprising:

the sliding sheath assembly engaging feature configured to enable rotational counter traction for stylet disengagement.

6. The system according to claim 1 further comprising:

the sliding sheath assembly configured to axially retract from the stylet a predetermined distance whereby electrodes of the biostimulation device are exposed, enabling threshold testing while the biostimulation device remains engaged to the stylet.

7. The system according to claim 1 further comprising:

the catheter tube comprising a sheath, the sheath configured with a sheath slot configured to align with an alignment pin of the biostimulation device that prevents rotation of the biostimulation device with respect to the sheath; and

the stylet extending along the axis from a knob coupled to a proximal end to a screw coupled to the distal end, the stylet configured whereby for the knob fully retracted the biostimulation device is fully contained within the sheath and a fixation member coupled to the biostimulation device is protected, and whereby for the knob fully depressed the alignment pin is contained within the sheath and electrodes of the biostimulation device are fully exposed, enabling threshold testing before disengagement.

8. The system according to claim 1 further comprising:

a catheter tube assembly extending from a knob end to a socket end and enclosing an internal lumen configured to axially slide over the stylet and engage the biostimulation device, the catheter tube assembly comprising a socket at the socket end that engages a corresponding nut on the biostimulation device whereby the stylet can be rotated relative to the catheter tube assembly for disengagement of the stylet threaded end from the biostimulation device threaded end.

9. The system according to claim 8 further comprising:

the stylet configured screw into a multiple-sided nut attached to the biostimulation device; and

the socket configured as a locking hex socket that engages the multiple-sided nut on the biostimulation device whereby the stylet and socket are configured to enable counter-rotation of the stylet relative to the biostimulation device.

10. The system according to claim 8 wherein:

the catheter tube assembly is a sheath-less catheter; and

the biostimulation device is a leadless cardiac pacemaker and the delivery system is configured to deploy the leadless cardiac pacemaker with active or passive fixation using the sheath-less catheter.

11. The system according to claim 8 further comprising:

the sheath-less catheter socket comprising the socket configured to enable rotational counter traction for stylet disengagement.

12. The system according to claim 11 further comprising:

a biocompatible soluble protective covering configured to cover a fixation member coupled to the biostimulation device during insertion of the biostimulation device into a patient'"'"'s body whereby the patient'"'"'s body tissue is protected.

13. The system according to claim 12 further comprising:

the biocompatible soluble protective covering comprising mannitol, polyvinylpyrrolidone, or a protective salt.

14. The system according to claim 8 further comprising:

the biocompatible soluble protective covering comprising a material that forms a protective capsule at room temperature, dissolves when implanted, and has no toxic side effects.

15. The system according to claim 8 further comprising:

the biocompatible soluble protective covering configured for dissolving in a selected time whereby a fixation device coupled to the biostimulation device is exposed, the fixation device being advanced by rotating the catheter tube assembly and the stylet until the biostimulation device is anchored.

16. The system according to claim 8 further comprising:

the catheter tube assembly circumferentially enclosing an inner lumen and the stylet extending through the lumen, the catheter tube assembly comprising a catheter knob at a proximal end and a multiple-sided nut socket at a distal end of the catheter tube assembly, the multiple-sided nut socket configured to receive external features of a multiple-sided nut coupled to a biostimulation device, the multiple-sided nut socket and biostimulation device multiple-sided nut configured to prevent counter-rotation of the biostimulation device and the catheter tube assembly when engaged; and

the stylet comprising a stylet knob at a proximal end and a threaded screw at a distal end of the stylet, the threaded screw configured for engaging the internally threaded nut of the biostimulation device.

17. The system according to claim 16 further comprising:

the catheter tube assembly extruded from polyurethane, polytetrafluoroethylene, polyolefin, polyvinyl chloride or silicone and having a diameter smaller than or equal to the biostimulation device;

the catheter knob constructed from rigid plastic or metal;

the stylet constructed from stainless steel;

the stylet knob constructed from rigid plastic or metal.

18. The system according to claim 16 further comprising:

the biostimulation device is a leadless cardiac pacemaker.

19. The system according to claim 1 further comprising:

the stylet and the catheter tube comprise the delivery system with only two concentric members forming a catheter.

20. The system according to claim 1 further comprising:

the stylet and the catheter tube configured for implanting the biostimulation device adapted for active or passive fixation to patient tissue.

21. The system according to claim 1 further comprising:

a radio-opaque marker adapted for coupling to the stylet, the catheter tube, and/or the biostimulation device for identification under fluoroscopy and facilitation of positioning.

22. A method for implanting a biostimulation device in patient body tissue comprising:

screwing a threaded end of a stylet into an internally threaded nut of the biostimulation device;

positioning the catheter tube whereby the biostimulation device is located adjacent a selected patient body tissue;

engaging a feature of the catheter tube against a corresponding feature on the biostimulation device whereby rotation of the catheter tube rotates the biostimulation device relative to the patient body tissue;

rotating the catheter tube whereby fixation device on the biostimulation device affixes to the patient body tissue; and

counter-rotating the stylet relative to the catheter tube whereby the threaded end of a stylet is unscrewed from the internally threaded nut of the biostimulation device.

23. The method according to claim 22 further comprising:

prior to positioning the catheter tube, axially sliding a catheter tube over the stylet and the biostimulation device whereby the stylet and biostimulation device are internally contained within the catheter tube.

24. The method according to claim 23 further comprising:

prior to locating the biostimulation device adjacent the selected patient body tissue, partially withdrawing the catheter tube whereby the patient body tissue is exposed to the fixation device on the biostimulation device for affixation.

25. The method according to claim 23 further comprising:

prior to unscrewing the stylet from the biostimulation device, partially withdrawing the catheter tube whereby the patient body tissue is exposed to electrodes of the biostimulation device; and

measuring signal amplitudes and pacing thresholds of the biostimulation device.

26. The method according to claim 22 further comprising:

withdrawing the stylet from the catheter tube; and

withdrawing the catheter tube from the patient'"'"'s body.

27. The method according to claim 22 wherein:

the biostimulation device is a leadless cardiac pacemaker; and

the patient body tissue is cardiac tissue.

28. The method according to claim 22 further comprising:

axially sliding a sheath over the stylet and a leadless cardiac pacemaker whereby the stylet and leadless cardiac pacemaker with active fixation member are internally contained within the sheath;

inserting the sheath and stylet combination intravenously either in a cephalic, subclavian, or femoral vein of a patient;

moving the sheath and stylet combination progressively towards patient cardiac tissue until a distal end of the sheath reaches a selected site of the cardiac tissue;

at the selected site gently advancing a stylet knob into the sheath to expose the active fixation member coupled to the leadless cardiac pacemaker;

rotating the sheath whereby the leadless cardiac pacemaker is rotated and the active fixation member is attached to the cardiac tissue;

upon sufficient attachment of the active fixation member retracting the sheath relative to the stylet knob whereby electrodes of the leadless cardiac pacemaker are exposed;

holding the sheath while rotating the stylet knob whereby the stylet is unscrewed and disengaged from the leadless cardiac pacemaker;

retracting the sheath and stylet combination from the patient'"'"'s cephalic, subclavian, or femoral vein.

29. The method according to claim 28 further comprising:

after exposure of leadless cardiac pacemaker leads, testing implanted leadless cardiac pacemaker pacing thresholds and signal amplitudes; and

positioning the leadless cardiac pacemaker until the pacing thresholds and signal amplitudes meet selected criteria.

30. The method according to claim 22 further comprising:

axially sliding a sheath over the stylet and a leadless cardiac pacemaker whereby the stylet and leadless cardiac pacemaker with passive fixation member are internally contained within the sheath;

inserting the sheath and stylet in combination to a selected location of a patient'"'"'s body tissue;

at the selected site gently retracting the sheath relative to the stylet knob position to expose the leadless cardiac pacemaker and the electrodes;

rotating stylet knob while holding the sheath stationary whereby the stylet is disengaged from the leadless cardiac pacemaker; and

retracting the sheath and stylet combination from the patient.

31. The method according to claim 30 further comprising:

after exposure of leadless cardiac pacemaker leads, testing implanted leadless cardiac pacemaker pacing thresholds and signal amplitudes; and

positioning the leadless cardiac pacemaker until the pacing thresholds and signal amplitudes meet selected criteria.

32. The method according to claim 30 further comprising:

inserting and positioning a guide wire under fluoroscopy to a selected location in a patient'"'"'s coronary sinus using a coronary sinus introducer system;

advancing a dilator and introducer over the guide wire to the selected location;

withdrawing the guide wire followed by the dilator whereby the introducer remains positioned at the selected location;

advancing the leadless cardiac pacemaker into the coronary sinus for positioning at the selected location and leadless cardiac pacemaker electrodes are exposed;

testing the leadless cardiac pacemaker at the selected location;

optionally repositioning and testing the leadless cardiac pacemaker to a predetermined test result; and

retracting the introducer from the patient.

33. A delivery apparatus for implanting a leadless cardiac pacemaker comprising:

a bi-concentric-axial element catheter configured for engaging to and disengaging from the leadless cardiac pacemaker via relative motion of an internal stylet element to an externally circumferential tube element.

34. The apparatus according to claim 33 further comprising:

the tube element comprising a feature that engages a corresponding feature on the leadless cardiac pacemaker whereby the stylet element can be rotated relative to the tube element for disengagement of a stylet threaded end from a leadless cardiac pacemaker threaded end.

35. The apparatus according to claim 33 further comprising:

the tube element comprising a sliding sheath configured to axially slide over the stylet and engaged leadless cardiac pacemaker and configured to protect patient tissue from damage during insertion of the leadless cardiac pacemaker, the sliding sheath comprising a feature that engages a corresponding feature on the leadless cardiac pacemaker whereby the stylet can be rotated relative to the sliding sheath for disengagement of the stylet threaded end from the leadless cardiac pacemaker threaded end.

36. The apparatus according to claim 33 further comprising:

the tube element comprising a sheath-less catheter extending axially from a knob end to a socket end and enclosing an internal lumen configured to axially slide over the stylet and engage the leadless cardiac pacemaker, the sheath-less catheter comprising a socket at the socket end that engages a corresponding nut on the leadless cardiac pacemaker whereby the stylet can be rotated relative to the sheath-less catheter for disengagement of the stylet threaded end from the leadless cardiac pacemaker threaded end; and

a biocompatible soluble protective covering configured to cover a fixation member coupled to the leadless cardiac pacemaker during insertion of the biostimulation device into a patient'"'"'s body whereby the patient'"'"'s body tissue is protected.