Direct pericardial access device with deflecting mechanism and method

• US 5,972,013 A
• Filed: 09/19/1997
• Issued: 10/26/1999
• Est. Priority Date: 09/19/1997
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Comedicus, Inc.
• Inventors: Schmidt, Cecil C.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/934,045
• Time in Patent Office: 767 Days
• Field of Search: 606/184, 606/185, 604/115, 604/264, 604/164, 604/272
• US Class Current: 606/185
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61M 2025/009 the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter

Abstract

The invention is directed to a device and method for minimally invasive access to the pericardial space of a human or animal patient. The disclosed pericardial access device includes a penetrating body axially mobile within the lumen of a guide tube. The guide tube includes a deflecting mechanism for deflecting the distal end of the penetrating body. In use, a patient'"'"'s pericardium is contacted with the distal end of the guide tube and suction is applied to form a pericardial bleb. The penetrating body is axially mobilized distally within the lumen of the guide tube until the deflecting mechanism deflects the penetrating body to cause the penetrating end of the penetrating body to enter the bleb of pericardial tissue at an angle oblique to the longitudinal axis of the guide tube.

Claims

1. A pericardial access device comprising:

(a) a non-piercing guide tube, said non-piercing guide tube having a lumen and including;

(i) a proximal end;

(ii) a distal end, said distal end having a distal port opening into said lumen;

(iii) a longitudinal axis;

(iv) a deflecting mechanism; and

(b) a penetrating body axially mobile within said guide tube lumen, said penetrating body including;

(i) a proximal end; and

(ii) a penetrating end having a penetrating axis

wherein, when said penetrating body is advanced distally within said guide tube lumen past said deflecting mechanism, said deflecting mechanism deflects said penetrating end such that said penetrating end axis is at an angle oblique to said non-piercing guide tube longitudinal axis.

2. A pericardial access device according to claim 1 wherein said oblique angle is about 20°

-80°

.

3. A pericardial access device according to claim 1 wherein said oblique angle is about 30°

-60°

.

4. A pericardial access device according to claim 1 wherein said deflecting mechanism is a wedge within said non-piercing guide tube lumen near said distal port opening.

5. A pericardial access device according to claim 1 wherein said deflecting mechanism is a deflecting tube.

6. A pericardial access device according to claim 1 wherein said proximal end of said non-piercing guide tube includes to a handle region.

7. A pericardial access device according to claim 6 wherein said handle region includes a limiting mechanism for limiting axial mobility of said penetrating body.

8. A pericardial access device according to claim 1 wherein said proximal end of said non-piercing guide tube includes a vacuum inlet assembly.

9. A pericardial access device according to claim 1 further comprising a guide wire.

10. A pericardial access device according to claim 9 further comprising a material transport tube.

11. A pericardial access device according to claim 1 wherein said distal end of said non-piercing guide tube further includes an axially directed shoulder in said lumen near said distal port.

12. A pericardial access device according to claim 1 further including an exterior sheath.

13. A pericardial access device according to claim 12 wherein said exterior sheath includes a reversibly sealed distal end.

14. A method for accessing the pericardial space of a patient comprising:

(a) passing a tubular device to a patient'"'"'s pericardium, said tubular device including;

(i) a guide tube, said guide tube including;

a longitudinal axis;

a lumen having a distal port at a distal end of said guide tube; and

;

(ii) a penetrating body having a penetrating end and a piercing tip for penetrating a pericardial bleb;

(b) contacting said patient'"'"'s pericardium with said distal end of said non-piercing guide tube;

(c) applying a suction force through said lumen of said guide tube to form said bleb from said patient'"'"'s pericardium within said lumen of said guide tube; and

(d) advancing said penetrating body distally in said guide tube lumen such that said penetrating end is at an angle oblique to said longitudinal axis of said guide tube when said piercing tip penetrates said bleb of pericardium.

15. A method according to claim 14 wherein said oblique angle is about 30°

to 60°

.

16. A method according to claim 14 wherein said guide tube includes a deflecting mechanism.

17. A method according to claim 16 wherein said deflecting mechanism is a wedge.

18. A method according to claim 16 wherein said deflecting mechanism is a deflecting tube.