Methods and systems for accessing the pericardial space

• US 8,000,807 B2
• Filed: 06/15/2010
• Issued: 08/16/2011
• Est. Priority Date: 10/29/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Morris, Mary M, Leckrone, Michael E., Ujhelyi, Michael R., Gardeski, Kenneth C.
• Primary Examiner(s): Gibson; Roy
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US12/815,624
• Publication Number:
  US 20100249729A1
• Time in Patent Office: 427 Days
• Field of Search: 607/119, 607/122, 607/126, 607/127, 607/131, 606/32
• US Class Current: 607/119
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2017/349 Trocar with thread on outside
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver treatment in the pericardial space are disclosed. A steerable instrument is advanced transvenously into the right atrium of the heart, and a distal segment is deflected into the right atrial appendage. A fixation catheter is advanced employing the steerable instrument to affix a distal fixation mechanism to the atrial wall. A distal segment of an elongated medical device, e.g., a therapeutic catheter or an electrical medical lead, is advanced through the fixation catheter lumen, through the atrial wall, and into the pericardial space. The steerable guide catheter is removed, and the elongated medical device is coupled to an implantable medical device subcutaneously implanted in the thoracic region. The fixation catheter may be left in place.

Claims

1. A method of transvenously accessing the pericardial space between a heart and its pericardium, the method comprising the steps of:

passing a fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter end openings and a distal tissue fixation mechanism through a venous pathway into the right atrium, the fixation catheter further comprising a penetrable seal closing the distal fixation catheter lumen end opening;

deflecting a distal segment of the fixation catheter within the right atrium to dispose the distal fixation mechanism and distal fixation catheter lumen opening proximate the atrial wall;

fixing the distal fixation mechanism to the atrial wall to engage and stabilize the atrial wall; and

advancing a distal segment of an elongated medical device through the fixation catheter lumen, the penetrable seal, the atrial wall, and into the pericardial space.

2. The method of claim 1, wherein the distal fixation mechanism comprises a fixation helix, and the fixing step comprises screwing the fixation helix into the atrial wall.

3. The method of claim 1, further comprising passing a distal tissue-penetrating element of an elongated penetration instrument through the fixation catheter lumen and through the penetrable seal out of the distal fixation catheter lumen opening and through the stabilized atrial wall to perforate the atrial wall.

4. The method of claim 3, wherein:

the elongated medical device comprises an electrical medical lead bearing one or more of a physiologic sensor and an electrode in a distal segment of an elongated lead body; and

the advancing step comprises advancing the electrical medical lead through the fixation catheter lumen, through the penetrable seal, and through the tissue wall perforation to dispose the distal segment in the desired location.

5. The system of claim 4, wherein the electrode comprises one or more of a sense electrode, a pace/sense electrode, a cardioversion/defibrillation electrode, and a stimulation electrode.

6. The system of claim 4, wherein the physiologic sensor comprises one of a pressure sensor, a temperature sensor, a cardiac motion sensor and an acceleration sensor.

7. The method of claim 1, wherein:

the elongated medical device comprises an electrical medical lead bearing one or more of a physiologic sensor and an electrode in a distal segment of an elongated lead body; and

the advancing step comprises advancing the electrical medical lead through the fixation catheter lumen and through the tissue wall to dispose the distal segment in the desired location.

8. The system of claim 7, wherein the electrode comprises one or more of a sense electrode, a pace/sense electrode, a cardioversion/defibrillation electrode, and a stimulation electrode.

9. The system of claim 7, wherein the physiologic sensor comprises one of a pressure sensor, a temperature sensor, a cardiac motion sensor and an acceleration sensor.

10. The method of claim 1, further comprising:

passing an elongated guidewire having a tissue penetrating distal tip through the fixation catheter lumen, the penetrable seal and the distal fixation catheter lumen end opening and through the stabilized atrial wall to perforate the atrial wall; and

wherein;

the elongated medical instrument comprises an electrical medical lead bearing one or more of a physiologic sensor and an electrode in a distal segment of an elongated lead body having a lead body lumen terminating in at least one distal lead body lumen opening; and

the advancing step comprises advancing the elongated electrical medical lead over the guidewire and the fixation catheter lumen, the penetrable seal and through the atrial wall perforation to dispose the distal segment in the pericardial space.

11. The method of claim 10, wherein the electrode comprises one or more of a sense electrode, a pace/sense electrode, a cardioversion/defibrillation electrode, and a stimulation electrode.

12. The method of claim 10, wherein the physiologic sensor comprises one of a pressure sensor, a temperature sensor, a cardiac motion sensor and an acceleration sensor.

13. The method of claim 10, wherein the distal tissue fixation mechanism comprises a distal tissue fixation helix, and the fixing step comprises screwing the distal fixation helix into the tissue wall to engage and stabilize the tissue wall.

14. The method of claim 1, wherein the deflecting step comprises:

passing a steerable stylet having a stylet outer member and a stylet inner member enabling deflection of a distal segment of the steerable stylet into the fixation catheter lumen enabling passage of the fixation catheter through a selected venous pathway into the right atrium of the heart; and

deflecting the steerable stylet distal segment within the right atrium to dispose the distal fixation mechanism toward the atrial wall.

15. The method of claim 14, further comprising the step of advancing a distal segment of the stylet outer member or the stylet inner member or both through the fixation catheter lumen, the penetrable seal, the atrial wall, and into the pericardial space.

16. The method of claim 1, wherein the deflecting step comprises:

passing a steerable guidewire having a guidewire outer member and a guidewire inner member enabling deflection of a distal segment of the steerable guidewire into the fixation catheter lumen enabling passage of the fixation catheter through a selected venous pathway into the right atrium of the heart; and

deflecting the steerable guidewire distal segment within the right atrium to dispose the distal fixation mechanism toward the atrial wall.

17. The method of claim 16, further comprising the step of advancing a distal segment of the guidewire outer member or the guidewire inner member or both through the fixation catheter lumen, the penetrable seal, the atrial wall, and into the pericardial space.

18. A method of transvenously accessing the pericardial space between a heart and its pericardium, the method comprising the steps of:

passing a fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings and a distal tissue fixation mechanism through a venous pathway into the right atrium;

deflecting a distal segment of the fixation catheter within the right atrium to dispose the distal fixation mechanism and distal fixation catheter lumen opening proximate the atrial wall;

fixing the distal fixation mechanism to the atrial wall to engage and stabilize the atrial wall;

passing an elongated guidewire having a tissue penetrating distal tip through the fixation catheter lumen and the distal fixation catheter lumen opening and through the stabilized atrial wall to perforate the atrial wall;

advancing a distal segment of an elongated medical device comprising an electrical medical lead bearing one or more of a physiologic sensor and an electrode in a distal segment of an elongated lead body having a lead body lumen terminating in at least one distal lead body lumen opening over the guidewire and through the fixation catheter lumen, through the atrial wall perforation, to dispose the distal segment in the pericardial space.

19. A method of transvenously accessing the pericardial space between a heart and its pericardium, the method comprising the steps of:

passing a fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings and a distal tissue fixation mechanism through a venous pathway into the right atrium;

deflecting a distal segment of the fixation catheter within the right atrium to dispose the distal fixation mechanism and distal fixation catheter lumen opening proximate the atrial wall and passing a steerable guidewire having a guidewire outer member and a guidewire inner member enabling deflection of a distal segment of the steerable guidewire into the fixation catheter lumen enabling passage of the fixation catheter through a selected venous pathway into the right atrium of the heart and deflecting the steerable guidewire distal segment within the right atrium to dispose the distal fixation mechanism toward the atrial wall;

fixing the distal fixation mechanism to the atrial wall to engage and stabilize the atrial wall;

advancing a distal segment of the guidewire outer member or the guidewire inner member or both through the fixation catheter lumen, the atrial wall, and into the pericardial space; and

advancing a distal segment of an elongated medical device over the guidewire outer member or the guidewire inner member or both and through the fixation catheter lumen, the atrial wall, and into the pericardial space.