Methods and Systems for Accessing the Pericardial Space

• US 20100249729A1
• Filed: 06/15/2010
• Published: 09/30/2010
• Est. Priority Date: 10/29/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ujhelyi, Michael R., Gardeski, Kenneth C., Morris, Mary M., Leckrone, Michael E.
• Granted Patent: US 8,000,807 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• 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 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; and

advancing a distal segment of an elongated medical device through the fixation catheter lumen, 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 2, wherein the fixation catheter further comprises a penetrable seal closing the distal fixation catheter lumen end opening, and the advancing step comprises advancing the elongated medical device through the penetrable seal.

4. The method of claim 1, wherein the fixation catheter further comprises a penetrable seal closing the distal fixation catheter lumen end opening, and the advancing step comprises advancing the elongated medical device through the penetrable seal.

5. The method of claim 4, 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.

6. The method of claim 5, wherein:

the elongated medical device further comprises a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening; and

the advancing step comprises advancing the therapeutic catheter through the fixation catheter lumen, through the penetrable seal, and through the tissue wall perforation to dispose the distal therapeutic catheter lumen opening in the desired location.

7. The method of claim 6, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter, and a drainage catheter.

8. The method of claim 5, 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.

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

10. The system of claim 8, wherein the physiologic sensor comprises one of a pressure sensor, a temperature sensor, a cardiac motion sensor and an acceleration sensor.

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

passing a steerable guide catheter having a guide catheter delivery lumen extending between proximal and distal guide catheter delivery lumen openings and a deflectable guide catheter distal segment through a selected peripheral vein to establish a transvenous route into the right atrium of the heart; and

deflecting the deflectable guide catheter distal segment within the right atrium to dispose the distal guide catheter delivery lumen end opening adjacent to the atrial wall.

12. The method of claim 1, 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; 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.

13. The system of claim 12, wherein the electrode comprises one or more of a sense electrode, a pace/sense electrode, a cardioversion/defibrillation electrode, and a stimulation electrode.

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

15. The method of claim 1, wherein:

the elongated medical device further comprises a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening; and

the advancing step comprises advancing the therapeutic catheter through the fixation catheter lumen and through the atrial wall to dispose the distal therapeutic catheter lumen opening in the pericardial space.

16. The method of claim 15, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter, and a drainage catheter.

17. The method of claim 1, further comprising:

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; and

wherein;

the elongated medical instrument comprises a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening; and

the advancing step comprises advancing the therapeutic catheter over the guidewire through the fixation catheter lumen and through the atrial wall perforation to dispose the distal therapeutic catheter lumen opening in the pericardial space.

18. The method of claim 17, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter, and a drainage catheter.

19. The method of claim 1, further comprising:

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; 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 through the fixation catheter lumen and through the atrial wall perforation to dispose the distal segment in the pericardial space.

20. The method of claim 19, wherein the electrode comprises one or more of a sense electrode, a pace/sense electrode, a cardioversion/defibrillation electrode, and a stimulation electrode.

21. The method of claim 19, wherein the physiologic sensor comprises one of a pressure sensor, a temperature sensor, a cardiac motion sensor and an acceleration sensor.

22. The method of claim 19, 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.

23. 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.

24. The method of claim 23, 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 atrial wall, and into the pericardial space.

25. The method of claim 24, wherein the elongated medical instrument comprises the steerable stylet.

26. The method of claim 24, wherein the elongated medical instrument comprises an instrument through lumen, and the advancing step comprises advancing the elongated medical device over the steerable stylet through the fixation catheter lumen, the atrial wall, and into the pericardial space to dispose the distal segment therein.

27. 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.

28. The method of claim 27, 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 atrial wall, and into the pericardial space.

29. The method of claim 28, wherein the elongated medical instrument comprises the steerable guidewire.

30. The method of claim 28, wherein the elongated medical instrument comprises an instrument through lumen, and the advancing step comprises advancing the elongated medical device over the steerable guidewire through the fixation catheter lumen, the atrial wall, and into the pericardial space to dispose the distal segment therein.

31. A method of transvenously accessing the pericardial space between a heart and its pericardium to perform a medical procedure on the heart, the method comprising the steps of:

passing a steerable guide catheter having a guide catheter delivery lumen extending between proximal and distal guide catheter delivery lumen openings and a deflectable distal segment through a selected peripheral vein to establish a transvenous route into the right atrium of the heart;

deflecting the deflectable distal segment within the right atrium to dispose the distal guide catheter delivery lumen end opening adjacent to the atrial wall;

passing an elongated fixation catheter, having a fixation catheter lumen extending from a fixation catheter proximal end to a fixation catheter distal end provided with a penetrable seal sealing the fixation catheter lumen at the fixation catheter distal end and a fixation helix terminating in a tissue penetrating tip extending from the fixation catheter distal end adapted to be rotated to screw into the tissue wall to stabilize the penetrable seal at the tissue wall, through the guide catheter delivery lumen to dispose the helical fixation member and penetrable seal at the desired location;

extending the fixation helix toward the atrial wall;

screwing the fixation helix into the atrial wall;

passing a distal tissue penetrating element of an elongated penetration instrument through the fixation catheter lumen out of the distal fixation catheter lumen opening and through the stabilized atrial wall; and

advancing a distal segment of an elongated medical device having a proximal connector into the pericardial space;

withdrawing the steerable guide catheter; and

coupling the proximal connector to an implantable medical device adapted to be implanted subcutaneously in the thoracic region.

32. The method of claim 31, wherein the step of passing the elongated medical instrument further comprises:

passing a tissue-penetrating instrument having a distal tissue-penetrating element through the fixation catheter lumen out of the distal fixation catheter lumen opening past the fixation helix and through the stabilized atrial wall;

withdrawing the tissue penetrating instrument from the fixation catheter lumen and incision; and

passing the elongated medical instrument through the fixation catheter lumen and atrial wall to dispose the distal therapy delivery end within the pericardial space.

33. A method of implanting an implantable therapy delivery device to deliver a therapy through an elongated medical device into the pericardial space between a heart and its pericardium, comprising the steps of:

transvenously accessing the pericardial space from a surgical incision by;

passing a steerable guide catheter having a guide catheter delivery lumen extending between proximal and distal guide catheter delivery lumen openings and a deflectable distal segment through a selected peripheral vein to establish a transvenous route into the right atrium of the heart;

deflecting the deflectable distal segment within the right atrium to dispose the distal guide catheter delivery lumen end opening adjacent to the atrial wall at a desired site;

passing a fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings and a distal tissue fixation helix terminating in a sharpened tip through said guide catheter delivery lumen to dispose said sharpened tip and distal fixation catheter lumen opening proximate the desired site;

screwing the distal fixation helix into the atrial wall to engage and stabilize the atrial wall; and

passing an elongated medical instrument extending between a distal therapy deliver end and a proximal connector end through the fixation catheter lumen and atrial wall to dispose the distal therapy delivery end within the pericardial space;

coupling the proximal connector end of the elongated medical instrument with the implantable therapy delivery device; and

subcutaneously implanting the implantable therapy delivery device, whereby a therapy is delivered via the elongated medical instrument extending through the fixation catheter lumen into the pericardial space during chronic implantation.

34. The method of claim 33, wherein the step of passing the elongated medical instrument further comprises:

passing a tissue-penetrating instrument having a distal tissue-penetrating element through the fixation catheter lumen out of the distal fixation catheter lumen opening past the fixation helix and through the stabilized atrial wall;

withdrawing the tissue penetrating instrument from the fixation catheter lumen and incision; and

passing the elongated medical instrument through the fixation catheter lumen and atrial wall to dispose the distal therapy delivery end within the pericardial space.