Peripheral entry biventricular catheter system for providing access to the heart for cardiopulmonary surgery or for prolonged circulatory support of the heart

• US 5,738,649 A
• Filed: 04/16/1996
• Issued: 04/14/1998
• Est. Priority Date: 04/16/1996
• Status: Expired due to Fees

• Current Assignee: Surgerx Medical, LLC
• Original Assignee: Cardeon Corporation
• Inventors: Macoviak, John A.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/632,883
• Time in Patent Office: 728 Days
• Field of Search: 604/40, 604/43, 604/53, 604/107, 604/264, 604/280, 604/282, 604/283, 604/284
• US Class Current: 604/43
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Described is a closed chest intravascular catheter system for a simultaneous biventricular approach to 1) intravascular cardiopulmonary surgery and 2) acute or prolonged mechanical circulatory support.

Claims

1. A biventricular vascular catheter system for providing access to a patient'"'"'s heart for cardiopulmonary surgery or for prolonged cardiopulmonary circulatory support of the heart comprising:

(a) an elongated catheter shaft advanceable from a peripheral vessel to and through all chambers of the heart, including across a septum, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having multiple fenestrations and a first inner lumen extending therein from a port in the distal end of the shaft to a location in the proximal end; and

(b) a succession of expandable members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body in a left heart, the first expandable member is located at the proximal end of the catheter shaft at the site of entry of the shaft into the patient, the second expandable member is located distal to the first expandable member which is dimensioned and configured so that it seats in the proximal descending thoracic aorta, a third expandable member distal to the second expandable member which is dimensioned and configured so that it seats between the coronary ostia and the brachiocephalic artery and a fourth expandable member distal to the third expandable member which is dimensioned and configured so that it seats in the left ventricular outflow tract, each such expandable member having an interior which is in fluid communication with an inflation lumen extending within the catheter shaft from a location from within the respective expandable member to a location in the proximal portion which is adapted to extend out of the patient.

2. The catheter system of claim 1, further having a second limb branch catheter connected to the catheter shaft at the proximal end, said limb catheter disposed to provide for drainage or perfusion of the peripheral vessel used as an entry for the catheter shaft.

3. The catheter system of claim 1, further having a self-sealing dual diaphragm chamber instrument entry port branching from the more distal-ending channel of the catheter and having inflow and outflow ports to connect the major blood channels to an oxygenator pump.

4. The catheter system of claim 1, further having a bullet-shaped guide having fenestrations which enables the guidance of the catheter into and through the chambers of the heart and which may be removed from the catheter while the catheter is located within the heart.

5. The catheter system of claim 1, wherein the catheter shaft contains multiple rings which support the catheter shaft and which are located along a portion of the shaft proximal from the distal end and distal to the expandable member closest to the distal end.

6. The catheter system of claim 1, wherein the catheter accommodates the selective perfusion or drainage of blood either separately or at the same time.

7. The catheter system of claim 1, wherein the catheter contains at least five expandable members whose positions along the catheter shaft may be adjusted to expand at desired positions to compartmentalize subcirculations.

8. The catheter system of claim 1, wherein the system includes a scalpel, an imaging system, a deployable device and a robotic instrument which passes through a lumen of the catheter shaft and which incises the septum of the heart to permit passage of the catheter from one heart chamber to the other.

9. A catheter system which comprises multiple catheters of claim 1, wherein each of said multiple catheters differ from one another in their outside diameter.

10. A catheter system which comprises multiple catheters of claim 1, wherein each of said multiple catheters differ from one another in the positions of their expandable members.

11. A catheter system which comprises a catheter of claim 1, wherein said catheter has two channels which slide independently from each other.

12. An elongated catheter tip advanceable from a peripheral vessel to and through all chambers of the heart, including across a septum, having a flexible shaft with a removable guide tip which slides within the shaft and a succession of rings which support the shaft wherein the rings are further supported by struts bridging two successive rings, said struts further being variously positioned around the circumference of the catheter and further wherein the flexible shaft contains one or more fenestrations.

13. A method for surgery of the left heart comprising:

(a) advancing to a location within a patient'"'"'s left heart chamber an elongated catheter advanceable from a peripheral vessel, said catheter having;

(i) a proximal end that is adapted to extend out of the patient;

(ii) a distal end that comprises a flexible retractable (removable) tip with multiple fenestrations and a succession of rings placed proximal from the distal end which support a lumen and which are further supported by struts bridging two successive rings, said struts further being variously positioned around the circumference of the catheter;

(iii) a succession of expandable members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, the first expandable member is located at the proximal end of the catheter shaft at the site of entry of the shaft into the patient, the second expandable member is located distal to the first expandable member which is dimensioned and configured so that it seats in a proximal descending thoracic aorta, a third expandable member distal to the second expandable member which is dimensioned and configured so that it seats between coronary ostia and a brachiocephalic artery and a fourth expandable member distal to the third expandable member which is dimensioned and configured so that it sits in the left ventricular outflow tract, each such expandable member having an interior which is in fluid communication with an inflation lumen extending within the catheter shaft from a location from within the respective expandable member to a location in the proximal portion which is adapted to extend out of the patient; and

(b) inserting robotic instruments for surgery into the catheter.

14. The method of claim 13, further wherein a limb catheter is attached to the catheter of claim 13 to perfuse an artery.

15. A method for surgery of the right heart comprising:

(a) advancing to a location within a patient'"'"'s right heart chamber an elongated catheter advanceable from a peripheral vessel, said catheter having;

(i) a proximal end that is adapted to extend out of the patient;

(ii) a distal end that comprises a flexible retractable (removable) tip with multiple fenestrations and a succession of rings placed proximal from the distal end which support a lumen and which are further supported by struts bridging two successive rings, said struts further being variously positioned around the circumference of the catheter;

(iii) a succession of expandable members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, the first expandable member is located at the proximal end of the catheter shaft at the site of entry of the shaft into the patient, the second expandable member is located distal to the first expandable member which is dimensioned and configured so that it seats at the opening of a right atrium, a third expandable member distal to the second expandable member which is dimensioned and configured so that it seats the catheter at a coronary sinus and a fourth expandable member distal to the third expandable member which is dimensioned and configured so that it sits distal along the catheter to a pulmonic valve, each such expandable member having an interior which is in fluid communication with an inflation lumen extending within the catheter shaft from a location from within the respective expandable member to a location in the proximal portion which is adapted to extend out of the patient; and

(b) inserting robotic instruments for surgery into the catheter, and adjusting or steering the distal end to access a right heart structure and a pulmonary artery.

16. The method of claim 15, further wherein a limb catheter is attached to the catheter of claim 15 to drain a vein.

17. A method for trans-septal surgery of a heart comprising:

(a) advancing to a location within a patient'"'"'s left heart chamber an elongated catheter advanceable from a peripheral vessel, said catheter having;

(i) a proximal end that is adapted to extend out of the patient;

(ii) a distal end that comprises a flexible retractable (removable) tip with multiple fenestrations and a succession of rings placed proximal from the distal end which support a lumen and which are further supported by struts bridging two successive rings, said struts further being variously positioned around the circumference of the catheter;

(b) advancing a catheter as described in step (a) above into a location into the right heart; and

further advancing the catheter across;

(c) advancing either the catheter of step (a) or the catheter of step (b) across an atrial or a ventricular septum; and

(d) inserting robotic instruments for surgery into either the catheter of step (a) or step (b).