Methods and apparatus for treating ischemic heart disease by providing transvenous myocardial perfusion

• US 6,186,972 B1
• Filed: 12/09/1998
• Issued: 02/13/2001
• Est. Priority Date: 09/16/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Burton, John, Shmulewitz, Ascher, Nelson, James A.
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): CAMPEN, KELLY SCAGGS
• Application Number:
  US09/208,807
• Time in Patent Office: 797 Days
• Field of Search: 128/898, 604/282, 604/7, 604/8, 604/9, 604/93, 604/916, 606/15, 606/7, 606/194, 623/1, 623/3, 623/11.11, 600/16
• US Class Current: 604/8
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• 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 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence

Abstract

Methods and apparatus for supplying retrograde perfusion of chronically ischemic myocardium by forming one or more transmural passageways between a cardiac chamber and the coronary venous vasculature. The placement, size and number of the passageways are selected, and portions of the venous vasculature or coronary ostium optionally partially or completely occluded, to maintain a parameter related to the pressure attained in the venous vasculature to a value less than a predetermined value.

Claims

1. Apparatus for use in treating ischemic heart disease by providing retrograde transvenous myocardial perfusion, the apparatus comprising:

a catheter configured to be disposed in a patient'"'"'s venous vasculature, the catheter having a lumen; and

means for forming one or more transmural passageways between a portion of the patient'"'"'s venous vasculature and a cardiac chamber so that a parameter corresponding to a peak pressure attained in the venous vasculature is less than a predetermined value.

2. The apparatus of claim 1 wherein the lumen comprises a curved portion that communicates with a skive in a lateral surface of the catheter.

3. The apparatus of claim 1 wherein further comprising means for achieving a preselected degree of occlusion of a segment of the venous vasculature.

4. The apparatus of claim 1 wherein the means for forming comprises a sharpened stylet.

5. The apparatus of claim 4 wherein the stylet further comprises an electrode for delivering RF energy.

6. The apparatus of claim 3 wherein the means for achieving a preselected degree of occlusion comprises a plug of open-cell foam having high durometer.

7. The apparatus of claim 3 wherein the means for achieving a preselected degree of occlusion comprises:

a deformable tubular member having a delivery diameter for transluminal delivery, and an expanded diameter, wherein the tubular member is deformably expanded by internal application of a radially outwardly directed force; and

a layer of open-cell foam affixed to an exterior surface of the deformable tubular member.

8. The apparatus of claim 3 wherein the means for achieving a preselected degree of occlusion comprises:

a volume of biocompatible polymer that is injected to form a plug in-situ.

9. A method of treating ischemic heart disease by providing retrograde transvenous myocardial perfusion, the method comprising:

providing a catheter configured for transluminal, percutaneous insertion, the catheter having means for forming a transmural passageway in myocardial tissue;

inserting the catheter transluminally and percutaneously through a patient'"'"'s coronary sinus to a position in the patient'"'"'s venous vasculature; and

actuating the means for forming to form a transmural passageway between the position and a cardiac chamber, the transmural passageway having a size selected to maintain a parameter related to a pressure attained in the patient'"'"'s venous vasculature to a value less than a predetermined value.

10. The method of claim 9 wherein actuating the means for forming comprises actuating the means for forming to form a transmural passageway having a size selected to maintain a peak pressure attained in the patient'"'"'s venous vasculature to a value less than 40 mm Hg.

11. The method of claim 9 further comprising implanting a plug in the patient'"'"'s venous vasculature proximally of the transmural passageway.

12. The method of claim 9 wherein implanting a plug further comprises depositing a volume of bio-compatible polymer that forms a plug in-situ.

13. A method of treating ischemic heart disease by providing retrograde transvenous myocardial perfusion, the method comprising:

providing a catheter configured for transluminal, percutaneous insertion, the catheter having means for forming a transmural passageway in myocardial tissue;

inserting the catheter transluminally and percutaneously through a patient'"'"'s coronary sinus to a position in the patient'"'"'s venous vasculature;

actuating the means for forming to form a transmural passageway between the position and a cardiac chamber, the position at which the transmural passageway is formed being selected to maintain a parameter related to a pressure attained in the patient'"'"'s venous vasculature to a value less than a predetermined value.

14. The method of claim 13 wherein inserting the catheter comprises inserting the catheter to a position selected to maintain a peak pressure attained in the patient'"'"'s venous vasculature to a value less than 40 mm Hg when the transmural passageway is formed.

15. The method of claim 13 further comprising implanting a plug in the patient'"'"'s venous vasculature proximally of the transmural passageway.

16. The method of claim 15 wherein implanting a plug further comprises depositing a volume of bio-compatible polymer that forms a plug in-situ.

17. A method of treating ischemic heart disease by providing retrograde transvenous myocardial perfusion, the method comprising:

(a) providing a catheter configured for transluminal, percutaneous insertion, the catheter having means for forming a transmural passageway in myocardial tissue;

(b) advancing the catheter transluminally and percutaneously through a patient'"'"'s coronary sinus to a position in the patient'"'"'s venous vasculature;

(c) actuating the means for forming to form a transmural passageway between the position and a cardiac chamber; and

(d) repeating (b) and (c) at a plurality of positions to form a number of transmural passageways, the number of transmural passageways selected to maintain a parameter related to a pressure attained in the patient'"'"'s venous vasculature to a value less than a predetermined value.

18. The method of claim 17 wherein repeating (b) and (c) comprises repeating (b) and (c) to form a number of transmural passageways selected to maintain a peak pressure attained in the patient'"'"'s venous vasculature to a value less than 40 mm Hg.

19. The method of claim 17 further comprising implanting a plug in the patient'"'"'s venous vasculature proximally of at least one of the number of transmural passageways.

20. The method of claim 19 wherein implanting a plug further comprises depositing a volume of bio-compatible polymer that forms a plug in-situ.