Method and kit for transvenously accessing the pericardial space via the right atrium

• US 6,200,303 B1
• Filed: 04/22/1999
• Issued: 03/13/2001
• Est. Priority Date: 04/30/1997
• Status: Expired due to Fees

• Current Assignee: Beth Deaconess Medical Center, Inc., 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: Waxman, Sergio, Verrior, Richard L.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/296,285
• Time in Patent Office: 691 Days
• Field of Search: 604/48, 604/500, 604/506, 604/507, 604/508, 604/509, 604/510, 604/513, 604/164-2-1, 604/164.1, 604/164.11, 604/171, 604/173, 604/181, 604/170.01, 604/170.02, 604/170.03
• US Class Current: 604/508
• 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 and kit for accessing the pericardial space take 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. The method includes the step of passing a guide catheter through a selected peripheral vein to establish a transvenous route to the right auricle of the heart. An infusion guide wire and a leading guide wire are passed through the guide catheter and into the right auricle so that a distal end of the leading guide wire is positioned against a wall of the right auricle. The leading guide wire is located within a lumen of the infusion guide wire and protrudes outward, preferably about 2 mm, from a distal end of the infusion guide wire. The wall of the right auricle is then pierced with the distal end of the leading guide wire. After the wall of the right auricle is pierced, at least one of the infusion guide wire and the leading guide wire are advanced into the pericardial space. Once in position, the infusion guide wire and/or the leading guide wire can be used as a conduit over which a desired catheter may be introduced for performing a specific medical procedure. Alternatively, the infusion guide wire and/or the leading guide wire can be used to perform a specific medical procedure without the introduction of an additional device into the pericardial space.

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 vein to establish a transvenous route to the right auricle of the heart;

(b) passing an infusion guide wire and a leading guide wire through said guide catheter and into the right auricle so that at least one of a distal end of said leading guide wire and a distal end of said infusion guide wire is positioned against a wall of the right auricle, said leading guide wire being located within a lumen of said infusion guide wire;

(c) piercing said wall of the right auricle with at least one of said distal end of said leading guide wire and said distal end of said infusion guide wire;

(d) advancing at least one of said infusion guide wire and said leading guide wire into the pericardial space; and

(e) using said at least one of said infusion guide wire and said leading guide wire to perform a specific medical procedure on the heart.

2. The method of claim 1, wherein said step (c) of piercing said wall of the right auricle is performed without attaching a distal end of said guide catheter to said wall of the right auricle.

3. The method of claim 2, wherein said leading guide wire has a greater length than said infusion guide wire, and wherein said step (c) of piercing comprises the step of:

simultaneously applying an axial force to said infusion guide wire and said leading guide wire until at least one of said distal end of said leading guide wire and said distal end of said infusion guide wire pierces said wall of the right auricle.

4. The method of claim 1, wherein step (d) of advancing at least one of said infusion guide wire and said leading guide wire comprises the step of:

simultaneously advancing said infusion guide wire and said leading guide wire into the pericardial space.

5. The method of claim 4, further comprising the step between steps (d) and (e) of removing said leading guide wire.

6. The method of claim 1, wherein step (d) comprises advancing said infusion guide wire into the pericardial space, and wherein the method further comprises the step between steps (d) and (e) of removing said leading guide wire.

7. The method of claim 6, wherein said step (e) of using said at least one of said infusion guide wire and said leading guide wire comprises the step of:

(e) using said infusion guide wire to deliver a substance to the pericardial space via said lumen of said infusion guide wire, wherein said substance is selected from a group consisting of a medication, a biological agent, a lubricant, a polymer, and a synthetic agent.

8. The method of claim 6, wherein said step (e) of using said at least one of said infusion guide wire and said leading guide wire comprises the step of:

(e) using said infusion 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 said lumen of said infusion guide wire,

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

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

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

9. The method of claim 8, further comprising the steps of:

(f) advancing said leading guide wire back through said infusion guide wire into the pericardial space;

(g) removing said infusion guide wire; and

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

10. The method of claim 9, wherein said step (h) comprises the steps of:

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

(1) passing an electrode catheter over said leading 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 leading 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 leading 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;

(4) passing a fluid removal catheter over said leading 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; and

(5) passing an imaging catheter over said infusion guide wire so that said imaging catheter is positioned in the pericardial space, and using said imaging catheter to observe at least one of heart muscles, coronary arteries, and the pericardium.

11. The method of claim 1, wherein step (e) comprises the step of using said infusion guide wire as a conduit over which a desired catheter may be introduced for performing said specific medical procedure.

12. The method of claim 11, wherein said step (e) further comprises the steps of:

(e) using said infusion 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 infusion 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 infusion 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 infusion 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;

(4) passing a fluid removal catheter over said infusion 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; and

(5) passing an imaging catheter over said infusion guide wire so that said imaging catheter is positioned in the pericardial space, and using said imaging catheter to observe at least one of heart muscles, coronary arteries, and the pericardium.

13. The method of claim 1, further comprising the step between steps (d) and (e) of removing said infusion guide wire.

14. The method of claim 13, wherein said step (e) of using said at least one of said infusion guide wire and said leading guide wire comprises the step of:

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

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

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

15. The method of claim 13, wherein step (e) comprises the step of using said leading guide wire as a conduit over which a desired catheter may be introduced for performing said specific medical procedure.

16. The method of claim 15, wherein said step (e) further comprises the steps of:

(e) using said leading 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 leading 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 leading 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 leading 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;

(4) passing a fluid removal catheter over said leading 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; and

(5) passing an imaging catheter over said infusion guide wire so that said imaging catheter is positioned in the pericardial space, and using said imaging catheter to observe at least one of heart muscles, coronary arteries, and the pericardium.

17. 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.

18. The method of claim 17, 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 one of fluoroscopic imaging and echocardiographic 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.

19. The method of claim 18, wherein said step (c) of piercing comprises the step of:

waiting, once said distal end of said leading guide wire 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 leading guide wire to pierce said wall of the right auricle.

20. The method of claim 1, wherein said step (d) of advancing at least one of said infusion guide wire and said leading guide wire into the pericardial space further comprises the steps of:

using one of fluoroscopic imaging and echocardiographic imaging to visually follow the progress of said at least one of said infusion guide wire and said leading guide wire into the pericardial space; and

confirming proper placement of said at least one of said infusion guide wire and said leading guide wire in the pericardial space when said at least one of said infusion guide wire and said leading guide wire begins to take the shape of the contour of the heart.

21. The method of claim 20, wherein said step (d) of advancing said infusion guide wire further comprises the step of:

simultaneously advancing said leading guide wire and said infusion guide wire into the pericardial space.

22. The method of claim 21, wherein said step (d) of simultaneously advancing said leading guide wire and said infusion guide wire further comprises the steps of:

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

confirming proper placement of said leading guide wire and said infusion guide wire in the pericardial space when said leading guide wire and said infusion guide wire begin to take the shape of the contour of the heart.

23. 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 vein to establish a transvenous route to the right auricle of the heart;

(b) simultaneously passing an infusion guide wire and an leading guide wire through said guide catheter and into the right auricle so that a distal end of said leading guide wire is positioned against a wall of the right auricle, said leading guide wire being located within a lumen of said infusion guide wire;

(c) piercing said wall of the right auricle with said distal end of said leading guide wire;

(d) advancing said infusion guide wire into the pericardial space; and

(e) removing the fluid from the pericardial space.

24. The method of claim 23, wherein said step (c) of piercing said wall of the right auricle is performed without attaching a distal end of said guide catheter to said wall of the right auricle.

25. The method of claim 23, wherein step (e) of removing fluid comprises the steps of:

removing said leading guide wire; and

using said infusion guide wire to remove the fluid from the pericardial space, the fluid being removed through said lumen in said infusion guide wire.

26. The method of claim 23, wherein said leading guide wire has a greater length than said infusion guide wire, and wherein said step (c) of piercing comprises the step of:

simultaneously applying an axial force said infusion guide wire and said leading guide wire until said distal end of said leading guide wire pierces said wall of the right auricle.

27. 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 vein to establish a transvenous route to the right auricle of the heart;

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

(c) piercing said wall of the right auricle with said distal end of said leading guide wire;

(d) advancing said leading guide wire into the pericardial space; and

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

28. The method of claim 27, wherein said step (c) of piercing said wall of the right auricle is performed without attaching a distal end of said guide catheter to said wall of the right auricle.

29. The method of claim 28, wherein said step (c) of piercing comprises the step of:

applying an axial force to a proximal end of said leading guide wire until said distal end of said leading guide wire pierces said wall of the right auricle.