Methods and systems for accessing the pericardial space

• US 7,758,521 B2
• Filed: 12/01/2004
• Issued: 07/20/2010
• Est. Priority Date: 10/29/1999
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): Gibson; Roy D
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US11/000,539
• Publication Number:
  US 20050165466A1
• Time in Patent Office: 2,057 Days
• Field of Search: 607/116, 607/119, 607/120, 607/122, 606/41, 606/108, 606/167, 604/167.02, 604/167.04, 604/263
• US Class Current: 600/585
• 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 system for accessing a desired location through a tissue wall within a patient'"'"'s body;

comprising;

an elongated fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings, a penetrable seal closing the distal fixation catheter lumen opening, and a distal tissue fixation mechanism,

an elongated steerable fixation instrument adapted to engage the elongated fixation catheter and steer the guide catheter distal end to the tissue wall, the steerable fixation instrument enabling extension of the distal fixation mechanism into the tissue wall to engage and stabilize the tissue wall;

an elongated penetration instrument comprising a guidewire having a tissue penetrating distal tip sized and adapted to be passed through the fixation catheter lumen, through the penetrable seal, and through the tissue wall, thereby creating a perforation through the tissue wall and into the desired location; and

a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening adapted to be advanced over the guidewire and 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.

2. The system of claim 1, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter and a drainage catheter.

3. The system of claim 1, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter and a drainage catheter.

4. The system of claim 1, wherein:

the steerable fixation instrument further comprises a steerable guide catheter having a guide catheter delivery lumen terminating in a delivery lumen exit port at a guide catheter distal end, a deflectable distal segment, and a deflector operable from the guide catheter proximal end to steer the guide catheter distal end to the tissue wall; and

the fixation catheter sized to be extend through said guide catheter delivery lumen to dispose said distal fixation mechanism and distal fixation catheter lumen opening proximate the tissue wall, the elongated fixation catheter adapted to be manipulated to extend the distal fixation mechanism away from the distal guide catheter delivery lumen opening into the tissue wall to engage and stabilize the tissue wall.

5. The system of claim 4, wherein the steerable guide catheter further comprises a guide catheter hub and an elongated guide catheter body having a guide catheter body sidewall extending between a guide catheter body proximal end and a guide catheter body distal end, the guide catheter body further comprising:

a delivery lumen extending between a delivery lumen entry port and a delivery lumen exit port at the guide catheter body distal end;

a deflection wire lumen extending between a wire port through the sidewall of the guide catheter body and a deflection wire lumen distal end; and

a deflection wire extending from a deflection wire proximal end through the wire port and through the deflection wire lumen to a deflection wire distal end fixed to the guide catheter body at the deflection wire lumen distal end.

6. The system of claim 1, wherein the steerable fixation instrument further comprises a steerable stylet having a tubular outer member having an outer member lumen and an inner member disposed in the outer member lumen, the tubular outer member sized to extend through the fixation catheter lumen, and the outer and inner members selectively movable with respect to one another to deflect a distal segment of the outer member and to thereby deflect a distal segment of the fixation catheter and to steer the fixation catheter distal end to the tissue wall.

7. The system of claim 6, wherein the steerable stylet functions as the elongated penetration instrument having a tissue-penetrating element sized and adapted to be passed through the fixation catheter lumen, through the penetrable seal, and through the tissue wall, thereby creating a perforation through the tissue wall and into the desired location.

8. The system of claim 6, wherein at least one of the inner and outer tubular members is extendable through the fixation catheter lumen, through the penetrable seal, and through the tissue wall and into the desired location.

9. The system of claim 1, wherein the distal tissue fixation mechanism comprises a distal tissue fixation helix, and the elongated fixation catheter is adapted to be rotated to screw the distal fixation helix into the tissue wall to engage and stabilize the tissue wall.

10. The system of claim 9, wherein the steerable fixation instrument further comprises a steerable stylet having a tubular outer member having an outer member lumen and an inner member disposed in the outer member lumen, the tubular outer member sized to extend through the fixation catheter lumen, and the outer and inner members selectively movable with respect to one another to deflect a distal segment of the outer member and to thereby deflect a distal segment of the fixation catheter and to steer the fixation helix toward the tissue wall.

11. The system of claim 10, wherein the steerable stylet functions as the elongated penetration instrument having a tissue-penetrating element sized and adapted to be passed through the fixation catheter lumen, through the penetrable seal, and through the tissue wall, thereby creating a perforation through the tissue wall and into the desired location.

12. The system of claim 9, wherein:

the steerable fixation instrument further comprises a steerable guide catheter having a guide catheter delivery lumen terminating in a delivery lumen exit port at a guide catheter distal end, a deflectable distal segment, and a deflector operable from the guide catheter proximal end to steer the guide catheter distal end to the tissue wall; and

the fixation catheter sized to be extend through said guide catheter delivery lumen to dispose said distal fixation helix and distal fixation catheter lumen opening proximate the tissue wall, the elongated fixation catheter adapted to be manipulated to extend the distal fixation helix away from the distal guide catheter delivery lumen opening to the tissue wall to enable screwing the fixation helix into the tissue wall.

13. The system of claim 9, wherein the elongated penetration instrument comprises one of a guidewire or a stylet having a tissue penetrating distal tip.

14. The system of claim 9, further comprising a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening adapted to be advanced 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.

15. The system of claim 14, wherein the therapeutic catheter comprises one of a therapeutic agent delivery catheter, a gene delivery catheter, a fluid sampling catheter and a drainage catheter.

16. The system of claim 9, wherein:

the elongated penetration instrument comprises a guidewire having a tissue penetrating distal tip; and

a therapeutic catheter having a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening adapted to be advanced over the guidewire 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.

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

18. The system of claim 9, wherein the elongated penetration instrument comprises a therapeutic catheter having a tissue penetrating distal tip and a therapeutic catheter lumen terminating in at least one distal therapeutic catheter lumen opening adapted to be advanced through the fixation catheter lumen, through the penetrable seal, and through the tissue wall to dispose the distal therapeutic catheter lumen opening in the desired location.

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

20. A system for accessing a desired location through a tissue wall within a patient'"'"'s body;

comprising;

an elongated fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings, a penetrable seal closing the distal fixation catheter lumen opening, and a distal tissue fixation mechanism,

an elongated steerable fixation instrument comprising a steerable guide catheter that comprises a guide catheter hub and an elongated guide catheter body having a guide catheter body sidewall extending between a guide catheter body proximal end and a guide catheter body distal end, the guide catheter body further comprising;

a delivery lumen extending between a delivery lumen entry port and a delivery lumen exit port at the guide catheter body distal end;

a deflection wire lumen extending between a wire port through the sidewall of the guide catheter body and a deflection wire lumen distal end; and

a deflection wire extending from a deflection wire proximal end through the wire port and through the deflection wire lumen to a deflection wire distal end fixed to the guide catheter body at the deflection wire lumen distal end; and

an elongated penetration instrument having a tissue-penetrating element sized and adapted to be passed through the fixation catheter lumen, through the penetrable seal, and through the tissue wall, thereby creating a perforation through the tissue wall and into the desired location,

wherein the fixation catheter is sized to be extend through said guide catheter delivery lumen to dispose said distal fixation mechanism and distal fixation catheter lumen opening proximate the tissue wall, the elongated fixation catheter adapted to be manipulated to extend the distal fixation mechanism away from the distal guide catheter delivery lumen opening into the tissue wall to engage and stabilize the tissue wall.

21. A system for accessing a desired location through a tissue wall within a patient'"'"'s body;

comprising;

an elongated fixation catheter having a fixation catheter lumen extending between proximal and distal fixation catheter lumen openings, a penetrable seal closing the distal fixation catheter lumen opening, and a distal tissue fixation mechanism,

an elongated steerable fixation instrument comprising a steerable stylet having a tubular outer member having an outer member lumen and an inner member disposed in the outer member lumen, the tubular outer member sized to extend through the fixation catheter lumen, and the outer and inner members selectively movable with respect to one another to deflect a distal segment of the outer member and to thereby deflect a distal segment of the fixation catheter and to steer the fixation catheter distal end to the tissue wall and adapted to engage the elongated fixation catheter and steer the guide catheter distal end to the tissue wall, the steerable fixation instrument enabling extension of the distal fixation mechanism into the tissue wall to engage and stabilize the tissue wall; and

an elongated penetration instrument having a tissue-penetrating element sized and adapted to be passed through the fixation catheter lumen, through the penetrable seal, and through the tissue wall, thereby creating a perforation through the tissue wall and into the desired location.