Delivery system for implantable biostimulator

• US 8,010,209 B2
• Filed: 10/13/2006
• Issued: 08/30/2011
• 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 M.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): EL-KAISSI, HIBA CARINE
• Application Number:
  US11/549,574
• Publication Number:
  US 20070088418A1
• Time in Patent Office: 1,782 Days
• Field of Search: 607/9, 607/27, 607/32, 607/119, 607/122, 600/373, 600/374
• US Class Current: 607/119
• 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 comprising a knob end and a threaded end configured to engage a threaded end of the biostimulation device; and

a catheter tube configured to axially contain the stylet, the catheter tube comprising a feature configured to engage a corresponding feature on the biostimulation device to provide rotational counter traction when the stylet is rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end, wherein the catheter tube further comprises;

a sliding sheath assembly configured to axially slide over the stylet and engaged biostimulation device and 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.

2. The system according to claim 1 further comprising:

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

3. The system according to claim 1 further comprising:

the sliding sheath assembly 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.

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

a stylet comprising a knob end and a threaded end configured to engage a threaded end of the biostimulation device; and

a catheter tube configured to axially contain the stylet, the catheter tube comprising a feature configured to engage a corresponding feature on the biostimulation device to provide rotational counter traction when the stylet is rotated relative to the catheter tube for disengagement of the stylet threaded end from the biostimulation device threaded end, the catheter tube comprising a sheath, the sheath comprising 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 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.

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

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

the tube element adapted to engage a corresponding feature on the leadless cardiac pacemaker wherein 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, the tube element comprising a sliding sheath configured to axially slide over the stylet and the leadless cardiac pacemaker, the sliding sheath configured to protect patient tissue from damage during insertion of the leadless cardiac pacemaker and to axially retract from the stylet a predetermined distance whereby electrodes of the leadless cardiac pacemaker are exposed, enabling threshold testing while the leadless cardiac pacemaker remains engaged to the stylet, 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.

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

a catheter comprising an internal stylet element and an externally circumferential tube element, the stylet configured for engaging to and disengaging from the leadless cardiac pacemaker via relative motion of the stylet and the tube element;

the tube element being configured to axially retract from the stylet a predetermined distance whereby electrodes of the leadless cardiac pacemaker are exposed, enabling threshold testing while the leadless cardiac pacemaker remains engaged to the stylet,

wherein the tube element further comprises a feature adapted to engage a corresponding feature on the leadless cardiac pacemaker to provide rotational counter traction wherein the stylet element can be rotated relative to the tube element for disengagement of the stylet from the leadless cardiac pacemaker.

7. The delivery apparatus of claim 6 wherein the tube element feature is further adapted to rotate the leadless cardiac pacemaker and affix a fixation member of the leadless cardiac pacemaker to patient tissue.