Implantable biostimulator delivery system

• US 8,855,789 B2
• Filed: 07/26/2011
• Issued: 10/07/2014
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jacobson, Peter M.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US13/191,229
• Publication Number:
  US 20110282423A1
• Time in Patent Office: 1,169 Days
• Field of Search: 607/9, 607/27, 607/32, 607/122, 607/126, 607/128, 606/343, 606/374
• 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 method for implanting a biostimulation device in a heart of a patient, the method comprising:

inserting a catheter, a stylet and leadless biostimulation device into the heart, the stylet having threads being engaged with the leadless biostimulation device, the leadless biostimulation device comprising a hermetic housing with an electrode coupled to the housing, the electrode covered by the catheter during the inserting step;

engaging heart tissue with the biostimulation device;

after the engaging and inserting steps, moving the catheter away from the heart tissue, thereby exposing the electrode, while maintaining the biostimulation device in contact with the tissue;

after the moving step, performing threshold testing on the heart with the electrode; and

rotating the stylet with respect to the biostimulation device while applying a counter-rotational force on the biostimulation device with the catheter, thereby disengaging the stylet threads from the biostimulation device, wherein the inserting step includes utilizing the stylet to maintain an engaging relation between the catheter and the leadless biostimulation device that prevents relative rotation therebetween.

2. The method of claim 1 wherein the biostimulation device comprises a fixation element, the fixation element being covered by the catheter during the insertion step, the moving step comprising exposing the fixation element.

3. The method of claim 2 wherein the fixation element comprises an active fixation element, the method further comprising affixing the fixation element to cardiac tissue.

4. The method of claim 2 wherein the fixation element comprises a passive fixation element.

5. The method of claim 1 further comprising repositioning the biostimulation device within the heart after the performing step.

6. The method of claim 5 further comprising performing threshold testing on the heart with the electrode after the repositioning step.

7. The method of claim 1 wherein the engaging step comprises anchoring the biostimulation device to the heart tissue.

8. The method of claim 7 wherein the anchoring step comprises rotating the biostimulation device with respect to the heart tissue.

9. The method of claim 1, wherein the engaging step includes rotating the catheter which causes the leadless biostimulation device to rotate thereby affixing a fixation element on a distal end of the housing to the cardiac tissue.