US20020092535A1

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Publication number: US20020092535A1
Application number: US10/062,409
Authority: US
Inventors: Peter Wilk
Original assignee: Wilk Patent Development Corp
Current assignee: Wilk Patent Development Corp
Priority date: 1996-06-19
Filing date: 2002-02-05
Publication date: 2002-07-18
Also published as: US5908028A; US5662124A; US6363939B1

Abstract

A cardiovascular treatment method utilizes an elongate flexible surgical instrument (e.g., catheter) having a distal end. A distal end portion of the instrument is inserted into a vascular system of a patient. A surgical head at the distal end of the instrument is positioned so that the head is disposed adjacent to myocardium tissue of the patient. The head is operated to form a recess in the myocardium tissue. Prior to operating the head to form the recess, a thickness of the myocardium tissue is measured, the recess formed during the operation having a length determined in accordance with the measured thickness of the myocardium tissue. The thickness measurement partially determines the length of the recess. The angle of entry of the recess with respect to the heart wall also partially determines the length of the recess: the greater the angle, the longer the recess can be for a given myocardium thickness.

Description

BACKGROUND OF THE INVENTION

This invention relates to a method for effectuating a coronary artery bypass.[0001]

Coronary arteries frequently become clogged with plaque which at the very least impairs the efficiency of the heart's pumping action and can lead to heart attack. The conventional treatment for a clogged coronary artery is a coronary by-pass operation wherein one or more venous segments are inserted between the aorta and the coronary artery. The inserted venous segments or transplants by-pass the clogged portion of the coronary artery and thus provide for a free or unobstructed flow of blood to the heart.[0002]

Such conventional coronary artery by-pass surgery is expensive, time-consuming, and traumatic to the patient. Hospital stay subsequent to surgery and convalescence are prolonged.[0003]

A new coronary artery by-pass technique is disclosed in U.S. Pat. No. 5,429,144. That technique utilizes a stent made of a biocompatible material and comprises steps of moving the stent in a collapsed configuration through a blood vessel of a patient's vascular system to the patient's heart, inserting the stent in the patient's myocardium so that the stent extends at least partially through the myocardium and only within the myocardium, and upon the disposition of the stent in the myocardium, expanding the stent from the collapsed configuration to a substantially tubular expanded configuration so that a blood flow path is formed at least partially through the myocardium.[0004]

Pursuant to U.S. Pat. No. 5,429,144, the stent may be disposed in the myocardium so that it extends only partially through the myocardium, from a coronary artery, upstream of a vascular obstruction, or from the left ventricle of the heart. Alternatively, the stent may extend completely through the myocardium to establish a blood flow path from the left ventricle to a coronary artery, downstream of a vascular obstruction. In any case, the stent is deployed so that it extends only within the myocardium and does not protrude beyond the heart tissues, either into the left ventricle or into the coronary artery.[0005]

Where the stent of U.S. Pat. No. 5,429,144 extends only partially through the myocardium and thus terminates within the cardiac tissues, the stent guides blood directly into the heart tissues and particularly into cardiac vesicles which naturally occur in the myocardium. The blood is naturally distributed from the vesicles into the cardiac tissues and is collected by the veins of the heart. Where the stent terminates within the myocardium and extends from a coronary artery, upstream of a vascular obstruction, the stent maintains its expanded form during diastole, so that blood pumped from the heart is forced into the stent and from thence into the cardiac tissues. Where the stent terminates within the myocardium and extends from the left ventricle, the stent may collapse during systole, under the compressive forces exerted by the contracting heart muscle. In that case, blood is delivered to the myocardium during diastole: blood flows into the stent from the left ventricle as the ventricle is filling with blood. Alternatively, where the stent terminates within the myocardium and extends from the left ventricle, the stent may maintain its expanded form during systole, despite the compressive forces exerted by the contracting heart muscle. In that case, blood is forced into the stent and from thence into the cardiac tissues during heart contraction.[0006]

According to U.S. Pat. No. 5,429,144, the coronary bypass method further comprises inserting a distal end portion of a catheter into the perforation or recess prior to the ejection of the stent, and sensing pressure on the catheter along the distal end portion, thereby determining a thickness of the myocardium at the perforation or recess. The stent is cut from a piece of stent material so that the stent has a length corresponding to the sensed or measured thickness of the myocardium at the perforation or recess.[0007]

U.S. Pat. No. 5,429,144 describes the use of a drill head during diastole to cut a perforation into the myocardium. The synchronization or coordination of the drilling and stent ejecting steps with heart action is implementable by computer. Where the stent is disposed in the myocardium so that the stent extends only partially through the myocardium from the patient's left ventricle, the stent is inserted into the myocardium from the left ventricle. Accordingly, a distal end of the catheter is passed into the left ventricle prior to the deployment of the stent, while the stent is moved in its collapsed configuration through the catheter and into the left ventricle of the heart.[0008]

OBJECTS OF THE INVENTION

An object of the present invention is to provide an improved method for forming a coronary artery by-pass to thereby enable the oxygenation of cardiac tissues.[0009]

Another object of the present invention is to provide a method for forming a coronary artery by-pass which does not require leaving a device in the patient.[0010]

A further object of the present invention is to provide such a method which is less invasive and less traumatic to the patient than conventional by-pass surgery.[0011]

SUMMARY

Basically, the present invention is directed to a stent-less coronary artery by-pass wherein one or more recesses are formed in the myocardium. The recesses open sufficiently during diastole to permit blood flow into the myocardium and the vesicles therein.[0012]

A cardiovascular treatment method in accordance with the present invention utilizes an elongate flexible surgical instrument (e,.g. catheter) having a distal end. A distal end portion of the instrument is inserted into a vascular system of a patient. A surgical head at the distal end of the instrument is positioned so that the head is disposed adjacent to myocardium tissue of the patient. The head is operated to form a recess in the myocardium tissue. Prior to operating the head to form the recess, a thickness of the myocardium tissue is measured, the recess formed during the operation having a length determined in accordance with the measured thickness of the myocardium tissue. The thickness measurement partially determines the length of the recess. The angle of entry of the recess with respect to the heart wall also partially determines the length of the recess: the greater the angle, the longer the recess can be for a given myocardium thickness.[0013]

The thickness of the myocardium may be measured by generating an ultrasonic pressure wave, sensing reflected pressure waves and analyzing the reflected pressure waves to determine the thickness. The ultrasonic pressure wave generator (e.g., a piezoelectric crystal) and the ultrasonic wave sensor (also a piezoelectric crystal) may be disposed in the catheter wall at the distal tip thereof, or at the distal tip of an ancillary instrument inserted through a lumen of the catheter.[0014]

Measuring the thickness of the myocardium may be implemented by operating a computer aided tomography scanning machine, a magnetic resonance imaging machine or an echocardiogram device.[0015]

Generally, it is contemplated that the recess terminates in the myocardium tissue and is formed from the left ventricle of the patient. Accordingly, the surgical head is disposed adjacent to an inner side of the myocardium tissue, inside the left ventricle, so that the recess extends from the left ventricle[0016]

According to a feature of the present invention, the surgical head is a contact laser tip. In that case, operating the surgical head includes transmitting monochromatic coherent electromagnetic radiation (laser energy) through the contact laser tip to the myocardium tissue. Alternatively, the surgical head may include a drill tip, the operating of the head including pushing the drill tip into the myocardium tissue and rotating the drill tip during the step of pushing.[0017]

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a schematic cross-sectional view of a human heart, showing a plurality of recesses formed in the myocardium for providing a plurality of pathways for guiding blood directly into the cardiac tissues from the left ventricle, in accordance with the present invention.[0018]

FIG. 2 is a partial cross-sectional view, on a larger scale, showing one of the recesses of FIG. 1.[0019]

FIG. 3 is partially a schematic longitudinal cross-sectional view and partially a block diagram of an instrument assembly for forming the recesses shown in FIG. 1.[0020]

FIG. 4 is partially a schematic longitudinal cross-sectional view and partially a block diagram of another instrument assembly for forming the recesses shown in FIG. 1.[0021]

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention seeks to oxygenate the cardiac muscle or myocardium MYO (FIG. 1) where a coronary artery AC is blocked with vascular plaque material VP. To that end, a distal end portion of an[0022]

angioplastic instrument

12 or14 (FIGS. 3, 4) is inserted through a femoral artery (not shown) and the aorta AO into the left ventricle VL. More particularly, a distal end of asteerable catheter16 or18 (FIGS. 3, 4) is inserted along a

predetermined path

92,94,96 through the vascular system of the patient and into left ventricle VL.

Instrument

12 or14 is then operated to form a plurality of

recesses

86,88 and90 in myocardium MYO for providing a plurality of pathways for guiding blood directly into the cardiac tissues from left ventricle VL. Recesses86,88, and90 extend from left ventricle VL and terminate within myocardium MYO. Each

recess

86,88, and90 thus extends only partially into myocardium MYO.

As illustrated in FIG. 3, angioplastic[0023]

surgical instrument

12 includes apiezoelectric transducer20 disposed at a distal tip ofcatheter16 and electrically connected to anultrasonic frequency generator22. Anotherpiezoelectric transducer24 disposed at the distal tip ofcatheter16 is operatively coupled to awave analyzer26 which serves to determine the thickness of myocardium MYO upon disposition of the distal end ofcatheter16 inside left ventricle VL.Wave analyzer26 is connected to adisplay28 for indicating a computed heart wall thickness to a vascular surgeon.

As further illustrated in FIG. 3, an[0024]

optical fiber

30 is inserted through alumen32 ofcatheter16. At a proximal end,fiber30 extends to alaser source34, while at adistal end fiber30 is provided with a surgical head in the form of atapered contact tip36 of conventional crystalline material.Tip36 delivers coherent monochromatic electromagnetic radiation fromlaser source34 to target tissues of the patient's heart HP (FIG. 1). Aposition encoder38 is operatively linked tofiber30 for measuring a linear displacement of the fiber during the formation of

recesses

86,88,90.Encoder38 is connected to display28 for indicating a measured fiber displacement to a vascular surgeon.

As depicted in FIG. 4,[0025]

catheter

18 is provided with a pair of

lumens

40 and42 which receive anultrasonic probe44 and anoptical fiber46, respectively.Ultrasonic probe44 includes an electroacousticpiezoelectric transducer48 disposed at a distal tip of the probe and electrically connected to anultrasonic frequency generator50. An acoustoelectricpiezoelectric transducer52 also disposed at the distal tip ofprobe44 is operatively coupled to awave analyzer54.Analyzer54 processes reflected ultrasonic wave pressures, sensed bytransducer52, to determine the thickness of myocardium MYO (FIG. 1) upon disposition of the distal end ofcatheter18 withprobe44 inside left ventricle VL. The results of the thickness computations ofanalyzer54 are transmitted to amonitor56 for display.

As additionally depicted in FIG. 4,[0026]

optical fiber

46 extends at one end to alaser source58 and is provided at an opposite end with a surgical head in the form of atapered contact tip60.Tip60 is made of conventional crystalline material and functions to deliver coherent monochromatic electromagnetic radiation fromlaser source58 to target tissues of the patient's heart HP (FIG. 1). Aposition encoder62 is coupled tofiber46 for measuring a linear displacement of the fiber during the formation of

recesses

86,88,90.Encoder62 is connected to monitor56 for indicating a measured fiber displacement.

As further shown in FIG. 4,[0027]

catheter

18 incorporates in its wall a plurality ofstrain gauges64 distributed along the catheter. Strain gauges64 are operatively connected to a computer ormicroprocessor66 which analyzes the signals from the strain gauges to determine the configuration ofcatheter18 inside the patient. The computed configuration is displayed onmonitor56, together with an image of internal organs of the patient. The image of the internal organs is produced, for example, by magnetic resonance imaging (MRI), computer aided tomography (CAT) or an echocardiograph.

Upon insertion of the distal end of[0028]

catheter

16 or18 into left ventricle VL and upon the orientation of the catheter tip at a predetermined angle a1 (FIG. 2) with respect to the perpendicular98 to the myocardium MYO, an a-c electrical current of ultrasonic frequency is transmitted from

generator

22 or50 to

transducer

20 or48 to produce an ultrasonic pressure wave. This pressure wave is reflected from inner and outer surfaces (not designated) of myocardium MY. The reflected ultrasonic pressure waves are sensed by

transducer

24 or52 and analyzed by

analyzer

26 or54 to determine the thickness of myocardium MYO in an area located immediately in front of the distal end ofcatheter16 orprobe44. Provided with cardiac wall thickness information viadisplay28 or monitor56, a vascular surgeon can determine an appropriate length for a

recess

86,88, or90 to be formed in the myocardium.

Recesses

86,88, and90 have a length sufficiently large to effectuate artificial cardiac vascularization but small enough to not traverse the myocardium.

Upon the determination of the entry location, entry angle a[0029]1 and the depth or length of therecess86 to be formed,laser fiber30 or46 (FIGS. 3,4) is ejected from

catheter

16 or18 and

contact tip

36 or60 is placed in contact with the myocardium tissues. Laser energy is transmitted from

source

34 or58 to formrecess86 at angle a1 in myocardium MYO.

Fiber

30 or46 is advanced a predetermined distance into myocardium MYO, the distance of penetration of

tip

36 or60 being ascertained by

position encoder

38 or62.

The formation of[0030]

recesses

86,88 and90 as described hereinabove may be implemented in part via a computer programmed to enable the timing of heart perforation, catheter insertion, and other operations so that those operations are performed only during the diastolic phase of a cardiac cycle. The programming and utilization of a computer in such a procedure will be clear to one skilled in the art from the teachings of U.S. Pat. No. 4,788,975 to Shturman et al., the disclosure of which is hereby incorporated by reference.

As stated above, it is contemplated that laser energy is transmitted along[0031]

fiber

30 or46 to form

recess

86,88 or90 only during a diastolic phase of a cardiac cycle. In some cases,

tip

36 or60 may be left in place in myocardium MYO during a limited number of systolic iterations, to enable completion of recess formation. Alternatively, the

contact tip

36 or60 may be removed during systole and reinserted during diastole until the recesses are formed.

After a cardiac vascularization operation as described above is completed, blood drains into[0032]

recesses

86,88,90 from left ventricle LV and penetrates to vesicles VCS in the myocardium MYO during diastole. The blood is naturally distributed from vesicles VCS into cardiac tissues and is collected by the veins (not shown) of the heart. Even though some of the blood may return to ventricle VL during systole (and from thence to aorta AO), enough blood remains in the myocardium to provide adequate oxygen and nutrients thereto.

In addition to one or[0033]

more recesses

86,88, and90 inserted from the left ventricle VL partially into myocardium MYO, one or more recesses may be formed to connect left ventricle VL with coronary artery AC, as described in U.S. Pat. No. 5,429,144, the disclosure of which is hereby incorporated by reference. As additionally described in U.S. Pat. No. 5,429,144, the formation of

recesses

86,88 and90 may be implemented with a rotary drill rather than a contact laser. U.S. Pat. No. 5,429,144 also discloses steering componentry which enables an operator to control, from outside the patient, an orientation of the distal tip of

catheter

16 or18 upon insertion of the catheter into the patient.

Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. It is to be noted, for example, that the measurement of cardiac wall thickness may be alternatively accomplished via an MRI machine, a CAT scanner or by an echocardiogram. For example, a “measuring rod” of a predetermined length may be inserted through the angioplastic catheter. A computer connected to a CAT-scanner, an MRI machine or other imaging device then automatically determines myocardium thickness by comparing the dimensions thereof to the known length of the “measuring rod.” The computer with scanner input may be additionally used to determine optimal locations and insertion angles of multiple stents, e.g.,[0034]

stents

86,88, and90.

Accordingly, it is to be understood that the drawings and descriptions herein are profferred by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.[0035]

Claims

What is claimed is:

1. A cardiovascular treatment method comprising the steps of:

providing an elongate flexible surgical instrument having a distal end;

inserting a distal end portion of said instrument into a vascular system of a patient;

disposing a surgical head at said distal end of said instrument so that said head is disposed adjacent to myocardium tissue of the patient;

operating said head to form a recess in the myocardium tissue; and

prior to operating said head to form said recess, measuring a thickness of said myocardium tissue, said recess having a length determined in accordance with the measured thickness of said myocardium tissue.

2. The method set forth inclaim 1 wherein measuring said thickness includes generating an ultrasonic pressure wave, sensing reflected pressure waves and analyzing the reflected pressure waves to determine said thickness.

3. The method set forth inclaim 2 wherein the generating of said ultrasonic pressure wave includes operating a transducer disposed at said distal end of said instrument.

4. The method set forth inclaim 1 wherein measuring said thickness includes operating a magnetic resonance imaging machine.

5. The method set forth inclaim 1 wherein measuring said thickness includes operating a computer aided tomography scanning machine.

6. The method set forth inclaim 1 wherein measuring said thickness includes taking an echocardiogram.

7. The method set forth inclaim 1 wherein said recess terminates in said myocardium tissue.

8. The method set forth inclaim 1 wherein distal end portion is inserted into a left ventricle of the patient, said head being disposed adjacent to an inner side of said myocardium tissue, inside said left ventricle, said recess extending from said left ventricle into said myocardium tissue.

9. The method set forth inclaim 8 wherein said recess terminates in said myocardium tissue.

10. The method set forth inclaim 1 wherein said surgical head is a contact laser tip, the operating of said head including transmitting monochromatic coherent electromagnetic radiation through said tip to said myocardium tissue.

11. The method set forth inclaim 1 wherein said surgical head includes a drill tip, the operating of said head including pushing said drill tip into said myocardium tissue and rotating said drill tip during said step of pushing.

12. The method set forth inclaim 1 wherein the operating of said surgical head is implemented during diastole.

13. The method set forth inclaim 12, further comprising operating a computer to synchronize the operating of said surgical head with the rhythm of said heart.

14. The method set forth inclaim 1 wherein said surgical head is operated so that said recess extends only partially through said myocardium tissue from a coronary artery of the patient.

15. The method set forth inclaim 1 wherein said surgical head is operated so that said recess extends only partially through said myocardium tissue from the left ventricle of the patient.

16. A method for supplying blood to the heart, comprising the step of directing blood directly into the myocardium via at least one recess formed surgically in the myocardium and extending only partially through the myocardium and only within the myocardium.

17. The method set forth inclaim 16 wherein said step of directing includes the steps of, during diastole, guiding blood into said myocardium through said recess and, during systole, closing said recess.