Method for treating a patient at risk of loss of cardiac function by cardiac ischemia

• US 7,392,077 B2
• Filed: 04/12/2004
• Issued: 06/24/2008
• Est. Priority Date: 11/05/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Mueller, Richard L., Chee, U. Hiram
• Primary Examiner(s): Smith; Ruth S
• Application Number:
  US10/822,600
• Publication Number:
  US 20040254451A1
• Time in Patent Office: 1,534 Days
• Field of Search: 606 13- 17, 606/41, 606/2, 606/27, 606/28, 606/167, 606/185, 600/407, 600/425, 600/427, 600/439, 600/481, 600/508, 601/2, 601/3, 604 20- 22, 604/57, 607/88, 607/89, 607/96, 607/99
• US Class Current: 600/427
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 17/3478 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 18/20 using laser
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin

Abstract

Various methods and devices for treating a patient who has lost, or is at risk of losing cardiac function by cardiac ischemia are disclosed. Treatment includes first imaging a patient'"'"'s heart, or a portion thereof, to identify underperfused regions of cardiac muscle, and a source of oxygenated blood that is proximate to the underperfused region. Between the underperfused regions and the oxygenated blood source, a target area is selected where thermal or mechanical injury is introduced, and optionally reintroduced, to convert initial capillary blush, resulting from the injury.

Claims

1. A method of treating a patient at risk of loss of cardiac function by cardiac ischemia, comprising

(a) imaging the patient'"'"'s heart, or a portion thereof, to identify (i) an underperfused region of cardiac muscle, (ii) a source of oxygenated blood that is proximate a boundary of the underperfused region, and (iii) a target area that includes said underperfused-region boundary and a tissue expanse lying between said oxygenated blood supply and said boundary;

(b) at each of a plurality of sites throughout the target area, introducing a stimulus effective to stimulate angiogenesis in myocardial tissue and form a capillary network from the source of oxygenated blood to the underperfused region, wherein the stimulus is an injury produced by a stimulus selected from the group consisting of a mechanical, laser, chemical, thermal, or ultrasonic stimulus; and

(c) sustaining a demand for oxygen at the underperfused region for a period sufficient to convert the capillary network into an arterial network.

2. The method of claim 1, wherein the injury is produced by a mechanical stimulus comprising a mechanical cutting device effective to produce an annulus of injury about a core of healthy cells.

3. The method of claim 1, wherein the stimulus is a mechanical stimulus produced by introducing into each of said sites, a wire device having a barbed segment, and the method further includes periodically moving the wire devices relative to the heart, to produce a prolonged angiogenic stimulus at said site.

4. The method of claim 1, wherein the demand for oxygen at the underperfused region is sustained by chemical methods.

5. The method of claim 1, wherein the demand for oxygen at the underperfused region is sustained by at least one implant adapted to elicit a foreign body response.

6. The method of claim 1, wherein the demand for oxygen at the underperfused region is sustained by at least one viral carrier.

7. The method of claim 1, wherein the demand for oxygen at the underperfused region is sustained by requiring the patient to follow an exercise regimen.

8. The method of claim 1, wherein the stimulus is introduced at a first time, and the demand for oxygen at the underperfused region is sustained by introducing a second stimulus at a second time different from the first time.

9. A method of treating a patient at risk of loss of cardiac function by cardiac ischemia, comprising

(a) imaging the patient'"'"'s heart, or a portion thereof, to identify (i) an underperfused region of cardiac muscle, (ii) a source of oxygenated blood that is proximate a boundary of the underperfused region. and (iii) a target area that includes said underperfused-region boundary and a tissue expanse lying between said oxygenated blood supply and said boundary;

(b) at each of a plurality of sites throughout the target area, introducing a stimulus effective to stimulate angiogenesis in myocardial tissue and form a capillary network from the source of oxygenated blood to the underperfused region,

wherein the source of oxygenated blood is one in which arteries less than about 1 mm branch into a plurality of surrounding arterioles, and in which arterioles with inner lumen diameters between about 50-200 microns are plentiful, and said sites are spaced from one another at a spacing of between 0.5 to 1 cm; and

(c) sustaining a demand for oxygen at the underperfused region for a period sufficient to convert the capillary network into an arterial network.

10. A method of treating a patient at risk of loss of cardiac function by cardiac isehemia, comprising

(a) imaging the patient'"'"'s heart, or a portion thereof, to identify (i) an underperfused region of cardiac muscle, (ii) a source of oxygenated blood that is proximate a boundary of the underperfused region, and (iii) a target area that includes said underperfused-region boundary and a tissue expanse lying between said oxygenated blood supply and said boundary,

wherein the underperfused region is in a myocardial region of either of the patient'"'"'s ventricles, the source of oxygenated blood is the interior of the underperfused heart ventricle region, and the target area includes the region of ventricle endocardium underlying the underperfused region;

(b) at each of a plurality of sites throughout the target area, introducing a stimulus effective to stimulate angiogenesis in myocardial tissue and form a capillary network from the source of oxygenated blood to the underperfused region;

wherein said stimulus is a mechanical injury produced by forming at selected target sites in the target area, elongate channels in the endocardium of the ventricle, where the depth and width of said channels, combined with the blood turbulence produced within the ventricle, is such as to minimize accumulation of blood clot material in the channels; and

(c) sustaining a demand for oxygen at the underperfused region for a period sufficient to convert the capillary network into an arterial network.

11. The method of claim 10, wherein the channels have both width and depth dimension between about 1-5 mm.

12. The method of claim 10, further including the step of introducing an angiogenic growth factor into target-area sites between the underperfused region and adjacent portions of an inner ventricle wall.

13. The method of claim 10, further including the steps of

(d) imaging the heart to identify (i) as a second source of oxygenated blood, coronary arterioles in the epicardial region of the ventricle overlying the underperfused heart-ventricle region, (ii) as a second target area, the area between the second source of oxygenated blood supply and the underperfused region, and the adjacent boundary of the underperfused region;

and

(e) introducing into the second target area, at selected sites therein, a stimulus effective to stimulate angiogenesis in the target area.

14. The method of claim 10, wherein the demand for oxygen at the underperfused region is sustained by chemical methods.

15. The method of claim 10, wherein the demand for oxygen at the underperfused region is sustained by at least one implant adapted to elicit a foreign body response.

16. The method of claim 10, wherein the demand for oxygen at the underperfused region is sustained by at least one viral carrier.

17. The method of claim 10, wherein the demand for oxygen at the underperfused region is sustained by requiring the patient to follow an exercise regimen.

18. The method of claim 10, wherein the stimulus is introduced at a first time, and the demand for oxygen at the underperfused region is sustained by introducing a second stimulus at a second time different from the first time.