Method for transvenously accessing the pericardial space via the right atrium

• US 5,968,010 A
• Filed: 04/30/1997
• Issued: 10/19/1999
• Est. Priority Date: 04/30/1997
• Status: Expired due to Fees

• Current Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Original Assignee: Beth Israel Deaconess Medical Center, Inc. (Beth Israel Lahey Health, Inc.)
• Inventors: Verrier, Richard L., Waxman, Sergio
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/841,344
• Time in Patent Office: 902 Days
• Field of Search: 604/280, 604/49, 604/264, 604/96, 604/164, 604/50-53
• US Class Current: 600/500
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

A method for placing various types of catheters into the pericardial space takes advantage of the fact that the right auricle is a thin-walled, low-pressure structure which can be readily penetrated without damaging the pericardium or the epicardium. A guide catheter is passed through a selected peripheral vein to establish a transvenous route to the right auricle of the heart. A needle catheter is then passed through the guide catheter and into the right auricle so that a distal end of the needle catheter is positioned against a wall of the right auricle. The wall of the right auricle is then pierced with the needle catheter. A guide wire is advanced through the needle catheter and into the pericardial space. Once in position, the guide wire can be used as a conduit over which a desired catheter may be introduced for performing a specific medical procedure.

Claims

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

(a) passing a guide catheter through a selected peripheral vein to establish a transvenous route to the right auricle of the heart;

(b) passing a needle catheter through said guide catheter and into the right auricle so that a distal end of said needle catheter is positioned against a wall of the right auricle;

(c) piercing said wall of the right auricle with said needle catheter;

(d) advancing a guide wire through said needle catheter and into the pericardial space; and

(e) using said guide wire to perform a specific medical procedure on the heart.

2. The method of claim 1, wherein said step (e) of using said guide wire comprises the steps of:

(e) using said guide wire to perform said specific medical procedure on the heart, said specific medical procedure being selected from the group consisting of

(1) withdrawing a fluid from the pericardial space via a lumen of said guide wire,

(2) delivering a fluid to the pericardial space via a lumen of said guide wire,

(3) using a conductor of said guide wire to deliver an electrical signal to the heart from within said pericardial space, and

(4) using a conductor of said guide wire to sense an electrical signal from the heart from within said pericardial space.

3. The method of claim 1, wherein said step (e) of using said guide wire comprises the steps of:

(e) using said guide wire as a conduit over which a desired catheter may be introduced for performing said specific medical procedure.

4. The method of claim 3, wherein said step (e) of using said guide wire further comprises the steps of:

(e) using said guide wire as a conduit over which a desired catheter may be introduced for performing said specific medical procedure, said desired catheter and said specific medical procedure being selected from the group consisting of

(1) passing an electrode catheter over said guide wire and into the pericardial space so that a distal end of said electrode catheter is maintained in contact with the epicardium, and using said electrode catheter to deliver electrical energy to said epicardium;

(2) passing an electrode catheter over said guide wire and into the pericardial space so that a distal end of said electrode catheter is maintained in contact with the epicardium, and using said electrode catheter to sense electrical energy from said epicardium;

(3) passing a drug delivery catheter over said guide wire so that a distal end of said drug delivery catheter is positioned in the pericardial space, and using said drug delivery catheter to deliver a pharmacologic agent to the pericardial space; and

(4) passing a fluid removal catheter over said guide wire so that a distal end of said fluid removal catheter is positioned in the pericardial space, and using said fluid removal catheter to remove fluid from the pericardial space.

5. The method of claim 1, wherein said step (a) of passing a guide catheter comprises the steps of:

placing an introducer sheath into the selected vein;

introducing a guide catheter into said vein through said sheath;

guiding said guide catheter downstream through said vein to one of the venae cavae;

guiding said guide catheter downstream through said one of the venae cavae to the right atrium; and

guiding said guide catheter through the right atrium and into the right auricle.

6. The method of claim 5, wherein said step (a) of passing a guide catheter further comprises the step of:

advancing said guide catheter into the right auricle so that a distal end of said guide catheter is placed against the wall of the right auricle; and

using fluoroscopic imaging to visually follow the progress of said guide catheter into the right auricle; and

confirming proper placement of said guide catheter against the wall of the right auricle when said distal end of said guide catheter moves with the beating of the heart.

7. The method of claim 6, further comprising the step between steps (d) and (e) of removing said needle catheter.

8. The method of claim 6, wherein said step (c) of piercing comprises the step of:

waiting, once said distal end of said needle catheter is positioned against said wall of the right auricle, for movement of the heart from its rhythmic beating to cause said distal end of said needle catheter to pierce said wall of the right auricle.

9. The method of claim 8, wherein said step (d) of advancing a guide wire further comprises the steps of:

using fluoroscopic imaging to visually follow the progress of said guide wire into the pericardial space; and

confirming proper placement of said guide wire in the pericardial space when said guide wire begins to take the shape of the contour of the heart.

10. The method of claim 1, wherein said step (c) of piercing comprises the step of:

waiting, once said distal end of said needle catheter is positioned against said wall of the right auricle, for movement of the heart from its rhythmic beating to cause said distal end of said needle catheter to pierce said wall of the right auricle.

11. The method of claim 10, wherein said step (d) of advancing a guide wire further comprises the steps of:

using fluoroscopic imaging to visually follow the progress of said guide wire into the pericardial space; and

confirming proper placement of said guide wire in the pericardial space when said guide wire begins to take the shape of the contour of the heart.

12. A method for transvenously removing fluid from the pericardial space between a heart and its pericardium to treat cardiac tamponade, the method comprising the following steps:

(a) passing a guide catheter through a peripheral vein to establish a transvenous route to the right auricle of the heart;

(b) passing a needle catheter through said guide catheter and into the right auricle so that a distal end of said needle catheter is positioned against a wall of the right auricle;

(c) piercing said wall of the right auricle with said needle catheter;

(d) advancing a guide wire through said needle catheter and into the pericardial space; and

(e) removing the fluid from the pericardial space.

13. The method of claim 12, wherein step (e) of removing fluid comprises the step of:

removing the fluid from the pericardial space through a lumen in said guide wire.

14. The method of claim 12, wherein step (e) of removing fluid comprises the step of:

passing a fluid removal catheter over said guide wire so that a distal end of said fluid removal catheter is positioned in the pericardial space; and

using said fluid removal catheter to remove pericardial fluid from the pericardial space.

15. A kit for transvenously accessing the pericardial space between a heart and its pericardium to perform a medical procedure on the heart, the kit comprising:

a guide catheter having sufficient length and flexibility to be inserted into the right atrium of a subject'"'"'s heart via a transvenous route;

a needle catheter having an outer diameter sufficiently small to be passed through a lumen of said guide catheter and having a distal tip capable of penetrating a wall of the said right atrium of the subject'"'"'s heart, said needle catheter having sufficient length to be passed through said guide catheter and having sufficient flexibility to permit said needle catheter to be passed through said guide catheter into the right atrium of the subject'"'"'s heart via a transvenous route; and

a guide wire having an outer diameter sufficiently small to be passed through a lumen of said needle catheter, said guide wire having sufficient length and flexibility to be passed through said needle catheter and into the pericardial space via a transvenous route and further to permit said guide wire to conform at least partially to the contour of the heart when said guide wire is extended outward from a distal tip of said needle catheter and into the pericardial space.

16. The kit of claim 15, further comprising:

an aspiration catheter having a lumen of sufficient diameter so that said aspiration catheter may be passed over said guide wire and into the pericardial space for the removal of fluid from the pericardial space to treat cardiac tamponade.

17. A method for placing a catheter in the pericardial space between a heart and its pericardium, the method comprising the following steps:

(a) passing a catheter from a selected peripheral vein and through a transvenous route to the right auricle of the heart;

(b) passing said catheter through a wall of the right auricle and into the pericardial space;

(c) monitoring a shape of said catheter as it is advanced into the pericardial space; and

(d) confirming proper placement of said catheter in the pericardial space when said shape of said catheter begins to conform to the contour of the heart.

18. The method of claim 17, wherein said catheter comprises:

a guide wire.

19. The method of claim 18, wherein fluoroscopic imaging is used to determine visually when said guide wire begins to take the shape of the contour of the heart.

20. The method of claim 19, further comprising the step of:

(e) using said guide wire as a conduit over which an additional catheter may be introduced for performing a specific medical procedure.

21. A method for placing a catheter in the pericardial space between a heart and its pericardium, the method comprising the following steps:

(a) passing a catheter from a selected peripheral vein and through a transvenous route to the right auricle of the heart;

(b) advancing said catheter so that a distal end of said catheter is placed against the wall of the right auricle; and

(c) waiting, once said distal end of said catheter is positioned against the wall of the right auricle, for movement of the heart from its rhythmic beating to cause said distal end of said catheter to pierce the wall of the right auricle.

22. The method of claim 21, wherein said catheter comprises:

a needle catheter.

23. The method of claim 22, wherein said step (b) of advancing said catheter comprises the step of:

confirming proper placement of said catheter against the wall of the right auricle when said distal end of said catheter moves with the beating of the heart.