US3565062A - Ultrasonic method and apparatus for removing cholesterol and other deposits from blood vessels and the like - Google Patents

Abstract

The method and apparatus of the invention relates to the removal of foreign deposits of material from vessels of living human beings, such as cholesterol from blood vessels, by means of accelerations of vibratory forces in the ultrasonic frequency range without causing any disruption or damage to the surrounding walls of the vessels. The layer of material is removed from the inner surface of a vessel of a human in vivo by supporting a portion of the wall of the vessel and inserting in the vessel a tool member having an output surface that is vibrated to provide peak accelerations of at least 1,000 g''s, as the output surface of the vibrated tool member is placed in contact with the material at substantially the supported wall portion so as to transmit the mechanical vibrations thereto for a time sufficient to effect disintegration of the contacted material, and at the same time effecting relative movement of the tool member relative to the vessel so as to progressively contact, disintegrate, and thereby remove the layer of material from the vessel.

Description

United States Patent [72] inventor Arthur Kurk 3,352,303 11/1967 Delaney 128/24 Riverdale, N.Y. 3,358,677 12/1967 Sheldon 128/24 [21] Appl. No. 736,653 3,368,280 2/ 1968 Friedman et al. 32/58 [22] Filed June 13, 1968 3,433,226 3/ 1969 Boyd 128/305 [45] Patented Feb. 23, 1971 FOREIGN PATENTS [73] Assignee Ultrasonic Systems Inc.

Plainview NY 847,950 8/1952 Germany 128/24.05

Primary Examiner-Richard A. Gaudet Assistant Examiner-Kyle L. Howell [54] ULTRASONIC METHOD AND APPARATUS FOR AttomeyLe0nard W. Suroff REMOVING CHOLESTEROL AND OTHER DEPOSITS FROM BLOOD VESSELS AND THE 11 Drawing Figs ABSTRACT: The method and apparatus of the invention relates to the removal of foreign deposits of material from vessels of living human beings, such as cholesterol from blood 128,303 ZS/3% vessels, by means of accelerations of vibratory forces in the ul- [51] Int. Cl. A61h,23/00, "asonic frequency range without causing any disruption or 1 17/00 damage to the surrounding walls of the vessels. The layer of [50] Field ofSearch 128/24, material is removed from the inner surface of a vessel of a 24.05, 2, 305, 303.14; 32/28, 58% 73/67, 67-5, human in vivo by supporting a portion of the wall of thevessel 69; 241/(lnquued); 175/ 56 and inserting in the vessel a tool member having an output surface that is vibrated to rovide eak accelerations of at least [56] References Cited 1,000 gs, as the output surface :f the vibrated tool member is UNITED STATES PATENTS placed in contact with the material at substantially the sup- 1,966,446 7/1934 l-layes 175/56X ported wall portion so as to transmit the mechanical vibrations 2,580,716 1 1952 Balamuth l28/24.05UX thereto for a time sufficient to effect disintegration of the con- 2,874,470 2/ 1959Richards 32/58 tacted material, and at the same time effecting relative move- 3,075,288 1] 1963 Balamuth et al 32/58 ment of the tool member relative to the vessel so as to progres- 3,076,904 2/ 1963 Kleesattelet a]. 32/58X sively contact, disintegrate, and thereby remove the layer of 3,213,537 10/1965 Balamuth et al 3 2/28 material from the vessel.

PATENTED FEB23 IQYI SHEET 1 [1F 3 FLUID SUPPLY INVENTOR. ARTHUR KURIS BYM ATTORNEY PATENTEnFzszamn 3.565.062

saw 2 OF 3 INVEN'I'OR. 88 ARTHUR KURIS ATTORNEY SHEET 3 UP 3 PATENIED FEB23 19m fQa /00a 50a INVENTOR. ARTHUR KURIS AT TOR NEY CROSS-REFERENCETO RELATED APPLICATION In my copending application Ser. No. 736,761 filed on Jun. 13, 1968, and which entire subject matter of the copending application is incorporated herein by reference as if fully set forth herein, I disclose one means of detecting the region of a vessel, such as found in the circulatory system having an excessive buildup of cholesterol or other foreign deposits therein.

BACKGROUND OF THE INVENTION This invention relates generally to improvements in surgical procedures wherein ultrasonic energy is utilized and more particularly to methods and apparatus for the removal of cholesterol and other foreign deposits from the blood vessels of living humans by the application of ultrasonic vibrations thereto.

The outstanding and unexpected results obtained by the practice of the method and apparatus of the present invention, are attained by a series of features, steps and elements, working together in interrelated combination, and may be applied to biological organisms in general and particularly the vascular system of humans, and hence will be so illustrated and described.

In my copending patent application, referred to above, the basic invention of detecting the change in cross-sectional area of the blood vessel where cholesterol or other deposits have accumulated is disclosed. What is under consideration in the present invention is the use of mechanical vibrations in the sonic and ultrasonic ranges for removing this buildup without damaging the surrounding tissue in the process.

Before proceeding to the details of the invention, let us first review briefly generally known facts of the circulatory system and the accumulation of cholesterol bearing and other foreign deposits in the vascular system. A human being begins life quite literally with a pure heart, but cholesterol and other substances not yet fully understood can begin to coat the inner layer of blood vessels. Once this coating process begins, the arterys normally smooth inner surface roughens and buckles. Its natural elasticity gradually disappears, and it no no longer helps move blood into the body. The pressure needed to force blood through these narrowing corridors slowly rises. Overworked, the heart becomes a candidate for cardiac trouble. Laboring to sustain life under the accumulation of fatty deposits contained in the arteries, the muscles of the heart thicken andlose their precious elasticity.

The cholesterol is usually deposited in the arteries, and this is perhaps because there the blood stream is at its swiftest and cholesterol is most easily torn off its carrier. Once cholesterol begins clogging up the inner surface of an artery, it narrows the bore and thus increases the blood pressure at that point. Furthermore, it reduces the elasticity of the arterial wall so that there is increased danger of a break under the additional stress. Furthermore, the internal surface becomes rough and ragged, offering opportunities for blood clots to form and perhaps block off a particular vessel entirely. This last is called thrombosis. When thrombosis occurs in the coronary arteries that feed the heart, the result is what is commonly known as a heart attack. The condition of cholesterol settling out on the inner walls of the arteries is known as atherosclerosis. Now that infectious diseases have been brought under such good control by means of vaccination, community hygiene and antibiotics, atherosclerosis has become the number one killer of mankind in the western world.

Although surgeons today can offer certain solutions such as to transplant new sections of human arteries to replace those clogged up, or use artificial tubing made of synthetic materials, I have discovered that the removal of portions of blood vessels is not required and that the cholesterol buildup may be removed with ultrasonic energy in accordance with the present invention.

OBJECTIVES OF THE INVENTION An object of the present invention is to provide a improved method and apparatus for performing surgical procedures on the vascular and other systems with ultrasonic energy.

Another object of the present invention is to provide an improved method and apparatus for removing foreign deposits from the vascular systemin vivo in the human body with ultrasonic energy.

Another object of the present invention is to provide an improved method and apparatus for the removal from blood vessels of humans in a rapid and safe manner accumulated foreign deposits with the exertion of a minimum of physical energy by the person effecting such removal.

Another object of the present invention is to provide an improved method and apparatus to ultrasonically root out the interior surface of a blood vessel and remove the rooted out material therefrom.

Another object of the present invention is to provide an improved method and apparatus to selectively disintegrate and remove layers of cholesterol from the blood vessels of living biological organisms.

Another object of the present invention is to provide an improved method and apparatus for removing foreign deposits from the blood vessels which avoids the possibility of damage, such as, scoring, scratching or piercing, the treated blood vessel.

Another object of the present invention is to provide novel apparatus adapted to be ultrasonically energized and employed in the surgical procedure.

Other objects and advantages of this invention will become apparent as the disclosure proceeds.

SUMMARY OF THE INVENTION The outstanding and unexpected results obtained by the practice of the method and apparatus of this invention are attained by a series of features, steps and elements assembled working together in interrelated combination. Briefly the applicant has now discovered that mechanical elastic vibrations of accelerations of 1,000gs properly transmitted to the vascular system in vivo may be employed to selectively separate cholesterol and other deposits from living organic tissue without harmful effects to the surrounding tissue. 4

In practicing the present invention, surgical procedures are involved to expose suitable blood vessels which are used as points of entry, and which procedure is discussed in U. S. Pat. No. 3,352,303 which relates to removal of blood clots using ultrasonic energy. Once the point of entry has been established the ultrasonic tool member is guided to the location of the foreign deposits in order that the wave energy from the end of the probe can be applied directly to the foreign deposits. Almost all critical areas in the cardiovascular system which are subject to cholesterol can, generally be reached by the insertion of a catheter to support the vessel which enters the body at a surgically exposed artery or vein in the area where the surgery involved is not significantly traumatic. Generally more than one such approach is available to reach any diseased area and hence an area that is nonvital can be selected for the point of entry. Thus, the procedure can be accomplished with a minimum of danger to the patients conditron.

The ultrasonic energy, properly controlled, may remove the accumulated foreign material substances, including cholesterol, from the blood vessel by disintegration and thereafter removed therefrom. The results of the present invention are accomplished by direct application of the ultrasonic mechanical vibratory energy directly to the layer of material formed by the foreign deposits at its location in the patients body. It has been determined that foreign deposits such as cholesterol, bonded to another material of higher fatigue strength as the blood vessel, is quickly and easily removed from the blood vessel by applying high frequency mechanical vibrations thereto so that the cholesterol or other material to be removed and its bond with the blood vessel wall disintegrate due to rapid fatigue failure or fracture. The vibra tions applied for removal of the cholesterol may have a frequency in the range between 1,000 and 1,000,000 cycles per second, preferably at least 10,000 cycles per second, and an amplitude in the range between 0.00001 and 0.1 inch, so as to develop extremely high peak accelerations, preferably of the order of at least 1,000gs.

in accordance with one aspect of the invention the blood vessel is essentially supported to a given cross-sectional area as by temporarily supporting the wall of the blood vessel and guiding therethrough the ultrasonically vibrating probe and transmitting the vibratory energy at a controlled frequency and intensity, for a selected period. of time without any damage to the surrounding tissue. The cholesterol under these conditions has been shown to effect a breakdown of the foreign substances into cellular particles which when a fluid is supplied forms a fluidized suspension which is pumped out and removed from the human.

Also as a consequence of the accessibility of almost all parts of the cardiovascular system to approach by a remotely inserted probe, the procedures of this invention permit the placement of the end of the probe directly in contact with the adhering deposits or in extremely close proximity thereto, thus permitting the vibratory energy of the ultrasonic tool member to propagate wave energy axially or longitudinally from the end of the tool member and directly into the adhering deposits, thereby providing an efficient transfer of energy into the adhering deposits, to be lysed and a consequent minimum generation of heat in adjoining tissues of the vessel.

In accordance with a feature of the invention, a flexible tubular catheter is inserted in the blood vessel for supporting it and providing a guiding channel for the subsequent or simultaneous insertion of the ultrasonic tool member within the tubular catheter. This procedure permits the tool member having an energy transmission member coupled thereto to be inserted within the tubular catheter and guided thereby and thus minimizes the danger of puncturing the wall of the blood vessel. The wall portion of the vessel is supported in a selected area which may axially extend over a distance of from 0.25 to 2.0 inches at one time, and the removal process is carried out at substantially the supported wall portion of the vessel to prevent any possibility of the tool member puncturing the vessel that it is engaged with. As the tool member is moved relative to the foreign material it is maintained in coaxial alignment with the support member in the supported area and a series of disintegrated particles of the material is formed which may be removed by applying a suction force through one of the passages in the catheter to remove them from within the vessel. For certain applications, depending upon the consistency of the material removed and the particle size thereof, it has been found that by supplying a treatment liquid, which may be of an antiseptic so as to maintain sterility at the treated portion, that contacts the output surface such that it is pressurized for the effectiveness of the liquid in mixing with the disintegrated particles and forming a fluidized suspension thereof is enhanced. A suction force is then applied adjacent the tool member to continuously remove the fluidized suspension therefrom. If desired the treatment liquid is supplied to the portion of the vessel from which the layer is removed and the suction is applied to this portion at spaced apart locations between which at least a portion of the vibrated tool member is interposed so that the suction induces the treatment liquid to flow across the vibrated tool member for insuring the continuous mixing and the removal of the material. The actual location is such that the treatment liquid may be supplied at the center of the vibrated tool member which forms one of the passages of the catheter and the suction is applied at the periphery of the vibrated tool member through a second passageway in the catheter. Also if desired the suction may be applied at the center of the vibrated tool member and the treatment liquid supplied at the periphery of the vibrated tool member.

In accordance with another aspect of the present invention, after the vessel has been exposed it is internally and axially supported in the portion from which the layer of material of accumulated foreign deposits is to be removed by inserting through the opening a support member in the form of the flexible hollow catheter having an external diameter selected to support the wall surface of the vessel and applying an outwardly directed force thereto. The support member is provided with a series of apertures in the form of slots, and due to the size of the front portion of the catheter it sufficiently compresses the cholesterol deposits such as to force them to flow into and through the apertures so that a plurality of raised portions or nibs extend inwardly through the wall portion and adapted to be individually removed. By retaining the catheter in fixed position the static force is maintained and a tool member, which either has been previously positioned in the catheter or is now inserted therein, is brought into engage ment with the portions of the cholesterol formed within the catheter. The tool member is ultrasonically vibrated and the output surface thereof is brought into engagement with the raised areas of cholesterol and by normal relative movement therebetween they are essentially shaved off or disintegrated and extend thereafter no more than the thickness of the wall of the catheter. The tool member may have a peripheral surface forrned to conform to the catheter bore or passageway such that movement of the tool member axially along the catheter permits one to simultaneously remove all of the raised cholesterol areas. This process is repeated by thereafter moving the catheter generally axially first to back off from the portion just treated and thereafter rotating it a number of degrees and moving it to a new position to once again form a number of raised portions contained within the passageway of the catheter. The tool is then repeatedly brought into engagement therewith to again remove the raised areas. This process is repetitively duplicated until a total axial layer of cholesterol is removed and then another portion of the blood vessel is selected having a substantial buildup thereon.

In accordance with a feature of the invention, in removing a layer of adhered foreign deposits one may employ a hand held instrument wherein the active tool output surface enjoys transverse vibration, compressional vibration, flexural vibrations or torsional vibrations or even combinations of said vibrations. For instance, torsional and compressional vibration combined, produce a kind of corkscrew" vibratory motion, which is particularly suitable for obtaining small foreign deposit samples for biopsy purposes.

BRIEF DESCRIPTION OF THE DRAWINGS Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself, and the manner in which it may be made and used, may be better understood by referring to the following description taken in connection with the accompanying drawings forming a part hereof, wherein like reference numerals refer to like parts throughout the several views and in which:

FIG. 1, is a side elevational view, of an ultrasonic system in accordance with the present invention;

FIG. 2, is a top elevational view of FIG. 1, illustrating the relationship of equipment;

FIG. 3, is an enlarged view illustrating the related components of the invention for removing the foreign deposits from within various vessels;

FIG. 4, is a side elevational view, partly broken away and in section, of the ultrasonic instrument utilized in accordance with the present invention;

FIG. 5, is a front elevational view of the ultrasonic instrument of FIG. 4;

FIG. 6, is an enlarged view in cross section illustrating the removal, in accordance with the invention, of cholesterol or other deposits from within a blood vessel;

FIG. 7, is a view taken along line 7-7 of FIG. 6; and

FIGS. 3-41, are enlarged views in cross section similar to FIGS. 6 and 7 showing other tool members that can be used in accordance with the invention.

PREFERRED EMBODIMENTS OF THE INVENTION Referring to the drawings in detail and initially to FIGS. 1- 7 thereof, it will be seen that thesurgical apparatus 10 briefly includes in assembled relation to each other support means 12 having a plurality of vertical legsl3 and a top 14 on which the human 15 may be supported during the surgical process for the removal from a blood vessel 16 (FIGS. 6 and 7) the cholesterol and other foreign material ordeposits 17 from a portion orremoval site 18 of thevessel wall 19 in vivo from the human. Ultrasonic removal means 35 is adapted to disintegrate the layer offoreign material 17 from the selectedportion 18 of the human with transferring means 60 cooperating therewith to produce afluidized suspension 62 containing the removedmaterial 17 and atreatment fluid 63, which may be continuously supplied to theremoval site 18 to assist in forming the suspension.

The selectedportion 18 within theblood vessel 16, as seen in FIGS. 6 and 7, is reached by using conventional medical techniques as by clamping off theblood vessel 16 and forming an incision, either in the immediate area of the foreign deposits or spaced therefrom, with the removal means 35 advanced through the blood vessel to perform the process of removing the adhered deposits from thewall 19 of the blood vessel as hereinafter explained in detail.

POSITIONING MEANS The integrated operating components of theapparatus 10 may be contained on or associated with positioning means 25 to provide equipment mobility for a variety of positions without necessitating changing of the position of the human 15, and includes a base 26 with a plurality ofcasters 27 for ease of movement and avertical leg 28 which extends therefrom for slidable engagement withbracket 29 which has secured theretoshelf 30 in any conventional manner. Thebracket 29 is provided with a vertical bore for receiving thevertical leg 28 and is provided with aslot 31 having abolt 32 extending therethrough to clamp the bracket in fixed position to thevertical leg 28. It is appreciated that other mechanical means may be employed to produce the desired horizontal and vertical movement of the operating components to remove foreign material from various portions of the body.

REMOVAL MEANS In accordance with the present invention, theforeign deposits 17 are removed from thevessel 16 by applying thereto high frequency mechanical vibrations so that the effect of such vibrations is to disintegrate theforeign deposits 17, or for certain deposits depending upon thematerial composition, thickness, etc., a rapid fatigue failure or fracture of the bond of the latter to thevessel 16 is obtained. The vibrations necessary to achieve the foregoing have a high frequency within the range between 1,000 and 100,000 cycles per second, and preferably of at least 10,000 cycles per second, and an amplitude within the range of 0.0001 inch so as to pro vide high peak accelerations, preferably of the order of at least 1,000g. Peak acceleration is equal to 4 11- Al! in which A is the amplitude and t is l/frequency. Thus, for example, with a frequency of 20,000 cycles per second and an amplitude of 0.002 inch, a peak acceleration of approximately 100,000g is obtained.

As illustrated in FIGS. 4 and 5, means 35 for ultrasonically removing deposits from theremoval site 18 in theblood vessel 16 may include anoscillation generator 36 mounted on theshelf 30 with apower cable 37, connected to anultrasonic motor 41, for effecting the necessary high frequency vibrations of the energy transmission cable or coupling member 42- (FIGS. 4 and 5) having a tool member 43 at its terminal end. The tool member 43 may have a variety of output edges or surfaces 50, illustrated in respect to FIGS. 611. Theultrasonic motor 41 may be in the form of a hand piece adapted for being hand heldand generally comprising atubular housing 44 into which aninseri unit 47 coupled to theenergy transmission member 42 for supporting the tool 43. Thegenerator 36 is an oscillator adapted to produce electrical energy having an ultrasonic frequency and having controls knobs 38, 39 and 40, for respectively selecting the frequency, intensity of the ultrasonic energy, and automatic frequency sweep, the latter intended to avoid overheating the transmission member during the removal process.

The power energy level is generally in the order of from 1 to watts depending on the length and diameter of thetransmission member 42. The generator is also preferably of the type having a built in frequency modulator which continuously varies the frequency. over a preselected frequency range. A transmission member vibrated at a given frequency of vibration and greater than one wave length in physical length will contain therein a series of nodes and antinodes or loops along thetransmission member 42. For prolonged periods of use of theultrasonic motor 41 the heat generated at the antinodes is substantial and a red glow at spaced. apart locations is visible. Applicant has found that this heating of localized portions of the transmission member, which results in a loss of acoustical efficiency, can be avoided by continuously varying the frequency of vibration. Accordingly, the generator is provided with means, well known in the art, for automatically sweeping the frequency over a given range, say from l5,000 to 40,000 cycles per second. This results in a continuous change of position of the loops and nodes along thetransmission member 42 while theoutput surface 50 remains at a loop. If the operative time is to be relatively short in duration then this feature of the generator need not be employed and theknob 40 left on its off position with the frequency selected byknob 39.

Theultrasonic motor 41 may be one of a variety of electromechanical types, such as electrodynamic, piezoelectric and magnetostrictive, with the use of hand directed tools of suitable configuration, which are readily replaceable or interchangeable with other work performing tools in acoustically vibrated material treating devices, that may be of the type disclosed in U.S. Pats. Nos. Re 25,033, 3,075,288, 3,076,904 and 3,213,537, and wherein each work tool member is rigidly joined, in end-to-end relationship to a connecting body or acoustic impedance transformer and to a transducer which may form an insert unit or assembly which is removably supported in a housing containing a coil in surrounding relationship to the transducer and receiving alternating current for producing an alternating electromagnetic field.

The transducer in theultrasonic motor 41 is longitudinally dimensioned so as to have lengths which are whole multiples of half-wavelengths of the compressional waves established therein at the frequency of the biassed alternating current supplied so that longitudinal loops of motion as indicated byarrow 48, occur at the end of theinsert unit 47 to which thetransmission member 42 is rigidly connected. Thus, the optimum amplitude of longitudinal vibration and hyperaccelerations of tool member 43 is achieved, and such amplitude is determined by the relationship of the masses of the rear portion 45 and front portion 46 of tool member 43,transmission member 42 andinsert unit 47, which may be made effective to either magnify or reduce the amplitude of the vibrations received from the transducer. Theultrasonic motor 41 may also be designed to transmit torsional vibrations to thetransmission member 42 so as to obtain an oscillatory motion at the freeend of the tool member 43 in the direction ofarrow 49 which imparts a degree of flexure to the tool member. The longitudinal and torsional vibration may be combined to obtain a corkscrew type motion.

The support means 75 hereinafter described in detail, includes a catheter orsupport member 76 coupled at itsrear portion 83 to the displacement means 55 which is adapted to pennit the surgeon to obtain relative axial movement between thetransmission member 42 andcatheter 76. The displacement means 55 includes a pair oflegs 56 and 57 respectively, secured together at their lower end bybands 58 and provided with gripping means in the form ofindividual lugs 59 that extend outwardly from the upper end of the legs for engagement by the fingers of the surgeon oroperator 22 in a manner hereinafter described. Thecatheter 76 is secured in any conventional manner to the bands and will move relative to thetransmission member 42. Thelegs 56 and 57 are in spaced relation to each other and may be contoured to conform to the cylindrical configuration of theultrasonic transducer housing 44.

The displacement means 55 is mounted for relative movement, with respect to theultrasonic motor 41 by providing a pair ofslots 65 on each of thelegs 56 and 57, and which slots accept headedfasteners 66 which extend from thecasing 44 through theslots 65 to permit free relative movement between theultrasonic motor 41 and displacement means 55. The lower end of thecasing 44 is provided with an annular shoulder 67' which is adapted to receive spring means in the form of a spring 6% which is contained within theshoulder 67 atone end thereof and in engagement with thebands 58 at the opposite end thereof. Thespring 68 applies a force in the direction ofarrow 69, so that the working surfaces of the displacement means and ultrasonic motor means are biassed away from each other whereby the force applied by the surgeon is required to obtain the relative movement between the tool and catheter. If desired the spring may be coupled to the displacement and ultrasonic motor means so as to force them together with a predetermined static force which might be varied in a conventional manner not shown. In this manner once the static force is determined for the particular size of blood vessel it may be adjusted accordingly. The spring means may yieldably urge the displacement means 55 and transducer means 41 relative to each other to a position wherein thetool member 42 is in a retracted or extended position.

As seen in FlG. 5, aflexible sleeve 70 is connected to the side of theultrasonic motor 41 so as to leave the rear 71 free for engagement by the thumb or any other finger of the surgeon to permit manual control of the relative displacement between thecatheter 76 andtool member 42. Extending through theflexible sleeve 70 is thepower cable 37 which is connected to thegenerator 36, and treatmentfluid supply conduit 61 anddifferential pressure conduit 64, which both form part of the transferring means 60, hereinafter described in detail.

SUPPORT MEANS To prevent the tool member 43 from possibly engaging and puncturing thewall 19 of theblood vessel 16 and to assure a selected depth of removal of theforeign deposits 17 therefrom support means 75 is provided which may be in the form of a support member orcatheter 76 of metallic or plastic material that is flexible to move through the blood vessel under the controlled guidance of the surgeon with anexterior surface 87 to transmit an axial force to thevessel 16 and support it in theremoval portion 18. The catheter is provided with one or more passageways or conduits, as seen best in FIGS. 6 and 7, including afirst passageway 77 through which thehollow transmission member 42 extends. A second passageway 78 is provided in thesupport member 76 to supply atreatment fluid 63 to theremoval site 18 and athird passageway 79 is provided to remove thefluid suspension 62 of removedparticles 20 andtreatment fluid 63 from theremoval site 18. As illustrated in H68. 6 and 7 thethird passageway 79 is provided in thehollow transmission member 42, except that if asolid transmission member 42 is used then the third passageway may be formed in thewall 82 of the catheter.

Thecatheter 76 extends as a sheath in telescoping relation to thetransmission member 42 which has the tool member 43 contained with or extending beyond the front surface 9!) of the catheter. The catheter in accordance with the embodiment iliustrated in H68. 6 and 7 is provided with a plurality of apertures through thewall 82 in the form of slots or grooves of sufiicient size to have the foreign deposits l7 squeeze therethrough and form one or more nibs E26 extending within thefirst passageway 77 and adapted to be removed therefrom by the tool member 43.

Thetransmission member 42 may be made of a metallic material such as Monel or stainless steel capable of transmitting torsional and longitudinal mechanical vibrations and either of a solid form or hollow but flexible for manipulation through thecatheter 76. The selection of the diameter of thetransmission member 42 will be obviously limited by the size of theblood vessel 16 from which the foreign materials are to be removed. Since the tool member 43 may be of enlarged cross-sectional area thetransmission member 42 may be of a substantially smaller diameter.

One or moreradial flanges 83, may be provided that are longitudinally spaced apart along thetransmission member 42 to engage the inner surface of thefirst passageway 77 and maintain thetransmission member 42 in coaxial alignment with the catheter. Theradial flange 85% may be in the form of individual teeth selected of a material to transmit a minimal of vibratory energy and in longitudinally spaced apart position along the length of thetransmission member 42 and located at substantially nodes of vibration where longitudinal vibration is at a minimum for the specific frequency the unit is designed for. By placing the radial flanges at nodes a minimum of vibratory energy is transmitted to thecatheter 76. Obviously if the system is employed withthe frequency continuously varying then the exact location is not as important.

The tool member 43 may be permanently attached to the end oftransmission member 42, for example, by brazing, solder or the like, or the tool may be provided with a threaded stud (not shown) adapted to be screwed into a tapped hole in the end of thetransmission member 42 for effecting the rigid connection of the tool thereto. in like manner the transmission means may be similarly secured to theinsert unit 47 for the transmission of the ultrasonic vibrations.

The tool member 43 has its rear portion 45 coupled to thetransmission member 42 and its front portion 46 terminating in a working oroutput surface 50 that extends in a plane sub stantially normal to the axis of thefirst passageway 77 as well as normal to longitudinal vibrations induced therein. The front portion 46 has a plurality of spaced apartbent tips 51 separated by grooves 52 with itsoutput surface 50 having a sharp edge to engage and disintegrate thenibs 86 of foreign deposits formed within thecatheter 76 through theopenings 85. The tips may be designed to produce either pure longitudinal vibration at thecutting edge 50 or elliptical vibrations may be therein obtained. Elliptical motion has the advantage of minimal contact with the inner surface of thefirst passageway 77 if a minimal clearance is provided.

The edges of the tools illustrated herein may be chiselshaped, needle point or hollow tube (FIGS. 6 and 7) depending on the consistency, location and thickness of foreign deposit. The vibrations of the tool tip may be torsional, or axial with the tool axis, or it may be transverse to said axis. In addition corkscrew vibration may be produced by a multifrequency handpiece which combines resonant torsional and longitudinal vibration in a tool tip. in some cases, it is useful to use elliptical vibrations such as can be produced by combining longitudinal and flexural waves in the tool tips.

TRANSFERRING MEANS Removal means 60 provides for the removal of theforeign deposits 17 from theremoval site 18 to adepository 91 having acover 92 from which the material is disposed, and which is mounted on theshelf 30 for retaining thefluidized suspension 62. Pump means 95 mounted on theshelf 30 is connected to thedepository 91 by atube 96 extending through thecover 92, and by maintaining thedepository substantially sealed the pump means 95 creates a differential pressure in thedepository 91 for obtaining either a pumping in or out therefrom of thefluidized suspension 62.

conventional manner (not shown) through thehousing 44 and terminates in thethird passageway 79 of thecatheter 76 so as to apply a suction force as indicated by thearrow 96 in FIG. 6.

To progressively cover a surface area and remove a layer of theforeign material 17 therefrom the ultrasonically vibrated tool is moved axially relative so asto-continually engage thenibs 86 and apply a suction force and atreatment fluid 63 to theremoval site 18. Thetreatment fluid 63 provided from afluid source 98 which throughconduit 64 is transmitted to the second passageway 78 and is preferably an antiseptic so that the surface may be maintained free of germs. The treatment liquid is pressurized by the tool member 43 which enhances the effectiveness of the liquid in mixing with the removed particles and forming a suspension thereof. The suspension may flow by means of gravity from the treated surface but preferably a suctionforce may be applied and utilized adjacent thetool. Y

Ultrasonic pumping means 99 may be relied upon either alone or in combination with the suction means to remove the particles ofmaterial 17 from'the'removal site 18. The pumping means may consist of formations on the wall of thetransmission member 42 as for example, threads, which direct the removedparticles 20 away from theremoval site 18.

OPERATION Once the location of theforeign deposits 17 has been located in a particular artery orother blood vessel 16 the surgeon then proceeds to gain access thereto in a conventional manner so as to be able to insert therein thecatheter 76 and tool member 43 in the surgically exposed artery or vein. In 'accordance with the embodiment in FIGS. 6 and 7, thecatheter 76 is threaded through thevessel 16 until theportion 18 is reached and thewall portion 19 is supported in the selected area which may axially extend over a distance of 0.25 to 2.0 inches at one time and the removal process is carried out at substantially the supported wall portion of thevessel 16 to prevent any possibility of the tool member 43 puncturing the vessel that it is engaged with. Thefront portion 83 of thesupport member 76 has an external diameter as defined bysurface 87 which applies an I outwardly extending axial force which sufficiently compresses thecholesterol deposits 17 as to force it to flow into and through theapertures 85 so that a plurality ofnibs 86 extend inwardly from thewall portion 82 into thefirst passageway 77.Thesupport member 76 is retained in position and the tool member 43 is in spaced relation to the catheter front end 950 and is now vibrated ultrasonically and brought into engagement with thenibs 86 by theoperator 22 properly manipulating the displacement means 55 associated with theultrasonic motor 41. Simultaneously thetreatment fluid 63 is supplied through thesecond passageway 77 to theremoval site 18 such that a fluidized suspension 81 is formed as theoutput surface 50 of the tool 43 is brought into engagement with thenibs 86 and the latter are essentially shaved off or disintegrated intoparticles 20 that mix with thetreatment fluid 63. The tool member 43 has anaxial output surface 50 such that by movement of the tool axially along thefirst passageway 77 all of the raised cholesterol areas are removed simultaneously.

A suction force is continuously applied through thethird passageway 79 such that the fluid suspension is removed and transferred todepository 91 and thereafter disposed of.

The process is repeated by thereafter moving thecatheter 76 generally axially backwards to move off from just treated portion and thereafter rotating the removal means 35 or the support member 76 a number of degrees to provide a new exposed cholesterol area and then once again repositioning thesupport member 76 such that in the same circumferential area additional nibs 6 are formed. The tool member 43 is then repeatedly brought into engagement with the nibs. This process is repetitively duplicated until a total axial layer of cholesterol is removed and then another portion of the blood vessel is selected having a substantial buildup thereon.

ADDITIONAL EMBODIMENTS OF THE INVENTION FIG. 8, illustrates another embodiment of theinvention 10a including atool member 43a which is adapted to remove a layer of foreign deposits having a given wall thickness and includes a circular rear portion 45a that is coupled to theenergy transmission member 42a and is hollow therethrough to provide thethird passageway 79a. Thefront portion 46a of the tool member has an annular configuration terminating in anoutput surface 50a which may be in the form of a sharp cutting edge and extending in a plane substantially parallel to the relative movement between the vessel 16a and thetool member 43a. Theoutput surface 50a may have va concave inner surface which may be contoured and dimensioned so as to provide relative components of motion, the resultant of which might be elliptical as indicated by thearrow 100a.

The front portion 840 of the support member 76a is provided with an outwardly extendingradial flange 93a adapted to provide support and maintain the blood vessel if required in a selected configuration so as to obtain proper removal of theforeign deposits 17a. The inner surface of the support member may be provided with an inwardly directed radially extending flange 940 so as to maintain a minimal contact area between thesupport member 760 and thetransmission member 42a. This is important since it is desirable to transmit a minimum of vibratory energy directly to thewall structure 19a of the vessel 16a. The support member 76a is provided with asecond passageway 78a through which thetreatment fluid 63a might be provided so as to provide the treatment fluid at substantially the portion 18a from which theforeign deposits 17a are being removed. One ormore apertures 54a may be provided through thetransmission member 42a so as to permit proper mixing of the fluid being provided.

In operation thefront end 84a of the catheter 76a is initially inserted in the opening of the vessel 16a provided by the surgeon and gradually brought into engagement with cholesterol buildup in a given portion 18a of the vessel. Thetool member 43a is provided with an annularperipheral output surface 50a, which may be of substantially the same diameter as the peripheral surface 874 of the front portion 840 of the catheter, and it may be brought into the vessel 16a simultaneously with the catheter 76a and thereafter by proper manipulation of the finger grip portion on the hand held instrument illustrated with respect to FIGS. 4 and 5, axial relative movement of thetool member 43a and catheter member 76a is obtained so that a peripheral layer offoreign deposits 17a is removed from thevessel wall 19a. The relative displacement between thefront end 90a of the catheter 76a and theoutput surface 50a of thetool member 43a is illustrated by the dimension A, and which dimension is usually maintained at a distance within the supported portion 18a, as indicated by the dimension L, to assure that in that distance a curvature of the vessel will not occur and thereby possibly pierce the wall with the vibratingtool member 43a. The dimension A will be dependent in part upon the diameter of the vessel and the degree of foreign deposits. As thetool member 43a is moved relative to the generally fixed support member 76a and disintegrates the same into a number ofparticles 20a, which as hereinabove explained may be provided by applying a differential pressure at the supported portion 18a in the form of a suction force such that the removed particles are removed via the third passageway79a in the direction ofarrow 96a. When thefluid supply 63a is used theresultant particles 20a are mixed therewith and form a fluidized suspension, which if the transmission member is of sufficient length this substantially aids in maintaining its temperature.

While inserting the tool member 430 and support member 76a into the vessel 16a in accordance with what is illustrated in FIG. 8, the vibratory energy may be simultaneously transllll mitted to thetool member 43a so as to obtain a reduction of friction between the relative movement of the assembled tool member and support member relative to the vessel l6a. This permits a free movement through an extended length of vessel in order to reach the portion lba where the deposit of cholesterol is sufficiently large and is to be removed.

H6. 9, illustrates another embodiment of the invention lb, including a support member 761) and tool member 43!: wherein theoutput surface 50b of the tool member 4312 is spherically shaped so as to be rounded and have a portion thereof continuously engage theforeign deposits 17b. The transmission member 4212 is supported within thefirst passageway 77!), which is in the form of an axial bore extending through the catheter 7M), and is supported by a plurality of radial flanges bbb provided on the transmission member 4% to maintain and support it axially therein and permit axial relative movement within the catheter.

The front portion 84b of the catheter 76b is provided with an outwardly extendingradial flange 91% terminating in anexterior surface 87!; that may have an axial length of from 0.25 to 2.0 inches to provide an axial support to the vessel 161) along the axial length L, which length exceeds the physical length of the radial flange 9%. The extent of axial relative movement, as indicated by the dimension A, between the tool member 53:) and the front end 9012 of the catheter is generally up to 3.0 inches but preferably in the range of 0.1 to b 1.0 inches, such that the removal process is being carried out in substantially the portion lb!) of the vessel lob supported by the catheter 7oz? as indicated by the distance L.

As seen in FlG. 9, the amount or degree of removal may be controlled such that a fine layer or film 2115 of foreign deposit i'ib is left remaining on the interior surface of the vessel wall i915. This prevents any possibility of scarring or scratching the vessel wall 1%. In this embodiment the fluid 63b is likewise provided in spaced relation to the tool member 431; through the third passageway 7% such that the removed particles 20b and fluid 63b are made to mix as they are subjected to the high frequency vibratory energy of the tool member 43b, which may be longitudinal as indicated by arrow 48b, as it is moved axially along the vessel lob thereof, and the mixture removed through thethird passageway 79b, in the direction ofarrow 96!). ln like manner as in H6. 8,apertures 54b may be provided in the wall section of thetransmission member 42b to permit movement of the fluid therethrough and across the output surface to pressurize the fluid 63b as it mixes with the removed particles 2%.

FIGS. Ill and 11, illustrate another embodiment 100 of the invention, wherein the support means 75c is adapted to selectively support a given portion 18:: of thevessel 16c and a controlled thickness of foreign deposits 17:: is removed. Thesupport member 76c is provided on its front portion 840 with a hollow carrier Wile which is provided with a cavity M30 terminating in an end face or supporting surface lillc for engagement with theforeign material 17c. Thetool member 43c, which is coupled to thetransmission member 42c, extends in the cavity 193:: in a direction substantially normal to the wall surface We. The end face i020 acts as the support for the vessel lc and is of sufficient cross-sectional area to permit controlled removal of the foreign deposits. The depth of removal, indicated by D, of the layer of material We from the wall We is controlled by extending theoutput surface 50c past the end face llilflr. The vibratory tool member l3c may have a bent tip 510 such that it extends beyond the hollow ca f. ltllic lilo distance D h' equal to the depth of rem l. The Ctfl'iui iillc "I .my small to permit it to be gradually moved along the surface of the vessel 265:; and in this manner the entire wail per does not have to be axially supported but the portion being worked upon thereof is. The actual process of removing the part cles is the same as previously disclosed wits respect tol 55. a and CONCLUSlON From the above disclosure, it is evident that the method and apparatus of this invention embraces an interrelated series of devices and instruments which can be advantageously employed for effectively removing foreign deposits from vessels of humans in vivo. ln accordance with the invention we have the removal of cellular material from selected portions in a persons body by the application of vibratory energy to a supported portion of a vessel combined with sterile pumping means to remove the disintegrated particles therefrom. The outer surface of the tool member may be of a diameter to remove a preselected layer of foreign deposits and may still leave remaining a slight layer of foreign deposits, this minimal layer might be removed by subsequent treatment with tool members of different sizes.

This invention also contemplates the use of tool members that have the structural characteristics, that are adapted to expand upon reaching the extended length of the support member such that it is automatically enlarged and adapted to perform its function of removal.

The treatment fluid is preferably an antiseptic solution so that the removal site may remain not only free of removed particles but sterile at the same time. The liquid is supplied to float away" the removed tissue and also maintain the work site at a controlled temperature as not to overheat the surrounding tissue and possibly cause permanent damage thereto. The necessity of cooling the removal or work site will be directly related to the type of foreign deposits being removed. An additional factor to be considered is the size of the surface area and thickness of the layer of foreign material to be removed. If desired the treatment fluid may be supplied at a preselected temperature just for this purpose. The support for the vessel may be provided by the tool member or the catheter depending on the dimensional relationship of each.

Although illustrative embodiments of the invention have been described in detail herein with reference to the accompanying drawing, it is to be understood that the invention is not limited to those precise embodiments, and that various changes and modifications may be effected therein without departing from the scope or spirit of the invention, except as defined in the appended claims.

lclaim:

1. A method of removing a layer of material from the inner surface of a vessel of a human in vivo, comprising the steps of:

a. supporting a portion of the wall of said vessel by applying an internally, outwardly directed force thereto at the proximate area from which the layer of material is to be removed,

b. inserting in said vessel a tool member having an output surface,

c. effecting mechanical elastic vibration of said tool member output surface to provide peak accelerations of at least 1,000g,

. placing the output surface of said vibrated tool member in contact with said material at substantially said internally supported wall portion so as to transmit said vibrations thereto for a time sufficient to effect disintegration of said contacted material,

e. effecting relative movement of said tool member relative to said internally supported wall portion so as to progressively contact, disintegrate, and thereby remove said layer of material from said vessel, and

f. controlling the depth of removal of said layer of material during the relative movement between said internally supported wall potion and said tool member.

a. A method as in claim It, further including the step of continuously removing said disintegrated material from said vessel.

3. A method as in claim 2, wherein said removal of said disintegrated material is facilitated by applying suction to said vessel.

A method as in claim 2, wherein said disintegrated material is removed through said vibrating tool member.

5. A method as in claim 2, wherein said material is removed from the said vessel by a combination of suction and ultrasonic pumping.

6. A method as in claim 1, wherein said layer of material is removed by:

a. supplying a treatment liquid to said portion so that contact of said output surface with said material pressurizes the liquid for enhancing the effectiveness of the liquid in mixing with the disintegrated material and forming a suspension thereof, and

b. simultaneously applying suction to said vessel adjacent said tool member to remove said suspension therefrom.

7. A method as in claim 6, wherein said treatment liquid is supplied to said portion and the suction is applied to said portion at spaced apart locations between which at least a section of said vibrated tool member is interposed so that the suction induces the treatment liquid to flow across said vibrated tool member for ensuring the continuous mixing and the removal of said material.

3. A method as in claim 1:

a. wherein said step of effecting mechanical elastic vibration of said tool member includes coupling to said tool member an energy transmission member terminating exteriorly of said vessel and vibrated at an ultrasonic rate, and

b. further including the step of maintaining said transmission member in spaced relation to said wall portion to prevent contact therewith.

9. A method as in claim 8, further including the step of continuously varying the frequency of vibration of said energy transmission member so as to change the position of said loops and nodes of vibration-therein, whereby substantial heat buildup along said energy transmission member at any location is prevented.

it). A method as in claim 1, wherein said relative movement between said tool member and said internally supported wall portion is controlled such that said output surface is maintained within said supported wall portion of said vessel.

11. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such that there is a substantial component of relative motion perpendicular to said output surface.

12. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such thatthere is a substantial component of relative motion parallel to said output surface.

13. A method as in claim 1, wherein said depth of removal is controlled by providing a support member having an outer cross-sectional area adapted for supporting said vessel, and providing said output surface with a similar configuration as said support member but of a different cross-sectional area, whereby the thickness of said removed layer is substantially equal to the difi'erence between said respective cross-sectional areas.

14. A method as inclaim 13 wherein:

a. said support member cross-sectional area has a circular configuration,

b. said output surface cross-sectional area of said tool member has a circular configuration, and

c. said relative movement between said tool member and said support member is along the longitudinal axis of said support member, so as to substantially remove a circular layer of said material from said vessel.

15. A method as in claim 1, wherein said material is of a relatively low fatigue strength relative to the fatigue strength of said vessel and said vibratory energy is applied for a time sufficient to effect fatigue fracture of said material to elfect said disintegration and of any bond of the latter to said vessel.

16. A method as in claim 1, wherein said step of supporting a portion of the wall of said vessel includes placing in said vessel a support member having a surface for engagement with and application of a radially outwardly directed force thereto, whereby said wall is supported along an axially extending portion.

17. A method as inclaim 16, including the step of supporting said wall along a length of said axially extended portion in the range of from 0.20 to 2 inches.

18. A method as inclaim 16, wherein said radially outwardly directed force is applied circumferentially to said wall along said axially extending portion.

19. A method as in claim 1, wherein said output surface of said tool member is elliptically vibrated.

20. A method as in claim 1, wherein said output surface of said tool member is torsionally vibrated.

21. A method as in claim 1, wherein said output surface is vibrated with simultaneous longitudinal and torsional vibration.

22. A method as in claim 1, wherein said tool output surface is vibrated in the frequency range of 10,000 to 100,000 cycles per second.

23. A method as in claim 1, further including the step of maintaining said material at a temperature below which permanent damage would occur to the surrounding wall, said temperature being maintained by supplying a treatment liquid at a preselected temperature.

24. A method as claimed in claim 1, wherein said vessel is a blood vessel.

25. A method as in claim 24, wherein said material removed is cholesterol.

26. A method as claimed in claim 24, wherein said blood vessel is an arterial.

27. A method as claimed in claim 24, wherein said blood vessel is a veinule.

28. A method as claimed in claim 24, wherein said blood vessel is an artery.

29. A method as claimed in claim 24, wherein said blood vessel is a vein.

30. A method as in claim 1;

a. wherein said wall portion is supported by applying said internally outwardly directed force and forming one or more nibs of said material extending inwardly from said supported wall portion, and

b. further including the step of maintaining said radial force during said relative movement of said tool member and said internally supported wall portion until said respective nibs are removed.

31. A method as inclaim 30, wherein said internally outwardly directed force is radially applied by inserting in said vessel a support member having a cross-sectional area adapted to apply said radial force to compress said material, said support member having a plurality of apertures adapted 1 to receive said compressed material and form said nibs, and said relative movement is axially between said tool member and said vessel to remove said nibs.

32. A method as in claim 1, wherein said portion of the wall of said vessel is supported by said tool member.

33. A method of removing a layer of material adhered to the inner surface of a blood vessel in vivo, comprising the step of:

a. providing an opening in a blood vessel,

b. lntemally axially supporting a portion of said vessel by inserting therein a support member having a contacting surface for engagement with and application of a radially outwardly directed force to support said portion of said blood vessel, said support member having an axially extending first passageway therethrough,

c. inserting in said vessel through said first passageway a tool member having an output surface,

d. supporting said tool member at one end of a transmission member extending through said first passageway and terminating at its opposite end exteriorly of said blood vessel,

e. vibrating said tool member at an ultrasonic rate by transmitting mechanical elastic energy waves to said transmission member,

f. mounting said transmission member in said first passageway to transmit a minimum of vibratory energy to said support member,

g. placing the output surface of said vibrating member in contact with said material at substantially said internally axially supported wall portion so as to transmit said vibrations thereto for a time sufficient to effect disintegration of said contacted material,

h. effecting relative movement of said tool member and said vessel so as to progressively contact, disintegrate, and thereby remove said layer of material from within said blood vessel,

i. supplying a treatment fluid through a second passageway to said supported portion adjacent said vibrating tool member for forming a suspension of said disintegrated material and treatment fluid,

j. applying a suction force through a third passageway to said supported portion adjacent said tool member to remove said suspension from said blood vessel, and

k. controlling the depth of removal of said material during the relative movement between said support member and said tool member.

34. A method as in claim 33, further including the step of controlling the relative movement between said tool member and said vessel such that said output surface is maintained within said supported portion of saidvessel 35. A method as in claim 33:

a. wherein said support member has a plurality of apertures extending between said contacting surface and said first passageway in the area of said supported portion, whereby said radially outwardly directed forces compresses said material and forms a plurality of nibs extending through said apertures and into said first passageway, and

b. wherein said relative movement is axially in said first passageway, whereby said tool member engages and removes said nibs.

36. Apparatus for removing a layer of material adhering to the inner surface of a vessel of a human in vivo, comprising a. means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed,

b. a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface adapted for engagement with said material,

c. vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member,

d. means adapted for effecting engagement of the output surface of said tool member with said material at substantially said supported wall portion so as to transmit said vibrations thereto for effecting disintegration of said contacted material,

e. means coupled to said tool member for effecting relative movement between said tool member and said means for internally supporting the vessel, wherein the output surface thereof is adapted to move within said supported wall portion, so as to progressively contact, disintegrate and thereby remove said layer of material from said vessel, and

f. means for controlling the depth of removal of said layer of material, said means including means for maintaining said means for internally supporting the wall potion and said tool member output surface in relatively fixed spaced relation to each other to define a spacing therebetween for controlling the depth of removal.

37. Apparatus as inclaim 36, wherein' said vibration generating means includes:

a. a vibration generator,

b. an ultrasonic motor connected to said vibration generator, and

c. a transmission member coupling said ultrasonic motor to said tool member for transmitting said ultrasonic vibrations thereto.

3%. Apparatus as inclaim 37, wherein said vibration generator includes means to continuously vary the frequency of vibration of said transmission member so as to vary the position of the loops and nodes of vibration therealong so as to prevent substantial heat buildup along said transmission member at any location thereon.

39. Apparatus as inclaim 37, wherein said means adopted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said wall portion of said vessel, and said transmission member extending through said passageway.

40. Apparatus as inclaim 39, further including radial support means maintaining said transmission member and support member in axially spaced relation to each other.

41. Apparatus as in claim 46), wherein said radial support means includes a plurality of radially extending flanges in longitudinally spaced relation to each other along said transmission member.

42. Apparatus as inclaim 41, wherein said radial flanges are provided substantially at loops of longitudinal vibration along said transmission member.

43. Apparatus as inclaim 39, wherein said support member is provided with a plurality of radially inwardly extending flanges in said passageway to support said transmission member.

44. Apparatus as inclaim 39, wherein said means for effecting movement of said tool member relative to said means for internally supporting comprises said transmission member coupled to said tool member.

45. Apparatus as inclaim 36, further including means to limit the relative movement of said tool member relative to said support means, such that said tool member output surface is adapted to remain within said supported wall portion.

46. Apparatus as inclaim 36, further including means for removing the disintegrated material from said vessel.

47. Apparatus as in claim 46, wherein said means for removing said disintegrated material includes suction means communicating with said vessel for removal of the disintegrated material therefrom.

48. Apparatus as inclam 36, further including a. means for forming a fluidized suspension substantially at said supported wall portion containing the disintegrated material, which includes means for supplying a treatment fluid to said supported portion, and

b. means for removing said fluidized suspension from the vessel so as to cave the supported wall portion substantially free of disintegrated material, said removing means including means adapted to communicate with said vessel for removal of said fluidized suspension therefrom.

49. Apparatus as inclaim 36, wherein:

a. said means adapted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said portion of said vessel to provide a selected configuration of given internal cross-sectional area therein, and

b. said tool member output surface having a similar configuration as said supported portion but of a different crosssectional area, such that said depth of removal is equal to the difference between said respective cross-sectional areas.

50. Apparatus as in claim 36:

a. wherein said means adapted for supporting a portion of said vessel includes a tubular member having an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said sup ported portion and a first passageway extending axially therethrough with a plurality of apertures connecting said first passageway and said exterior surface, and

51. Apparatus as inclaim 50, including means for advancing said tool member axially through said first passageway to engage said nibs and remove them. i

52. Apparatus for removing a layer of material adhering to the inner surface of vessel a of a human in vivo, comprising:

means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed, said support means including a support member adapted to be inserted therein and having a first passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said wall portion of said vessel, a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface for engagement with said material, vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member, said vibration generating means including 1. a vibration generator, 2. an ultrasonic motor connected to said vibration generator, and 3. a transmission member coupling said ultrasonic motor to said tool member for transmitting ultrasonic vibrations thereto, said transmission member extending through said first passageway for axial relative movement therewith and containing a third passageway, means maintaining said transmission member extending through said first passageway in axially spaced relation to said support member, means adapted for effecting engagement of the output surface of said tool member with said material at substantially said supported wall portion so as to transmit said vibrations thereto for effecting disintegration of said conmeans for controlling the depth of removal of said layer of material, which includes means for maintaining said support member and said tool member output surface in relatively fixed spaced relation to each other, as said tool member is moved relative thereto,

. means for forming a fluidized suspension substantially at said support member, which means includes means for supplying a treatment fluid through a second passageway contained within said support member and means adapted for removing said fluidized suspension from the vessel so as to leave the supported wall portion substantially free of disintegrated material, said removing means including suction means communicating with said support member for removal of said fluidized suspension through said third passageway in said transmission member.

537 Apparatus as in claim 52, wherein said tool member is vibrated in the range of 1,000 to 500,000 cycles per second.

54. Apparatus as in claim 52:

wherein said tool member is adapted for movement within said first passageway), wherein said support mem er has an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said supported portion and a plurality of apertures connecting said first passageway and said exterior surface, and

. said exterior surface adapted to provide a radially outward pressure to compress said material and effect a flow of said material through said apertures to form a plurality of nibs in said first passageway, such that said relative movement of said tool member removes said nibs contained therein.

Claims (55)

1. 2. A method as in claim 1, further including the step of continuously removing said disintegrated material from said vessel.
2. 2. an ultrasonic motor connected to said vibration generator, and
3. 3. a transmission member coupling said ultrasonic motor to said tool member for transmitting ultrasonic vibrations thereto, said transmission member extending through said first passageway for axial relative movement therewith and containing a third passageway, d. means maintaining said transmission member extending through said first passageway in axially spaced relation to said support member, e. means adapted for effecting engagement of the output surface of said tool member with said material at substantially said supported wall portion so as to transmit said vibrations thereto for effecting disintegration of said contacted material, f. means for effecting relative movement of said tool member causing the output surface thereof to move relative to said support member so as to be adapted to progressively contact, disintegrate and thereby remove said layer of material from said vessel, g. means to limit the relative movement of said tool member relative to said support member, such that said tool member output surface is adapted to remain within said supported wall portion, h. means for controlling the depth of removal of said layer of material, which includes means for maintaining said support member and said tool member output surface in relatively fixed spaced relation to each other, as said tool member is moved relative thereto, i. means for forming a fluidized suspension substantially at said support member, which means includes means for supplying a treatment fluid through a second passageway contained within said support member and j. means adapted for removing said fluidized suspension from the vessel so as to leave the supported wall portion substantially free of disintegrated material, said removing means including suction means communicating with said support member for removal of said fluidized suspension through said third passageway in said transmission member.
4. 3. A method as in claIm 2, wherein said removal of said disintegrated material is facilitated by applying suction to said vessel.
5. 4. A method as in claim 2, wherein said disintegrated material is removed through said vibrating tool member.
6. 5. A method as in claim 2, wherein said material is removed from the said vessel by a combination of suction and ultrasonic pumping.
7. 6. A method as in claim 1, wherein said layer of material is removed by: a. supplying a treatment liquid to said portion so that contact of said output surface with said material pressurizes the liquid for enhancing the effectiveness of the liquid in mixing with the disintegrated material and forming a suspension thereof, and b. simultaneously applying suction to said vessel adjacent said tool member to remove said suspension therefrom.
8. 7. A method as in claim 6, wherein said treatment liquid is supplied to said portion and the suction is applied to said portion at spaced apart locations between which at least a section of said vibrated tool member is interposed so that the suction induces the treatment liquid to flow across said vibrated tool member for ensuring the continuous mixing and the removal of said material.
9. 8. A method as in claim 1: a. wherein said step of effecting mechanical elastic vibration of said tool member includes coupling to said tool member an energy transmission member terminating exteriorly of said vessel and vibrated at an ultrasonic rate, and b. further including the step of maintaining said transmission member in spaced relation to said wall portion to prevent contact therewith.
10. 9. A method as in claim 8, further including the step of continuously varying the frequency of vibration of said energy transmission member so as to change the position of said loops and nodes of vibration therein, whereby substantial heat buildup along said energy transmission member at any location is prevented.
11. 10. A method as in claim 1, wherein said relative movement between said tool member and said internally supported wall portion is controlled such that said output surface is maintained within said supported wall portion of said vessel.
12. 11. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such that there is a substantial component of relative motion perpendicular to said output surface.
13. 12. A method as in claim 1, wherein said relative movement of said tool member and said internally supported wall portion is such that there is a substantial component of relative motion parallel to said output surface.
14. 13. A method as in claim 1, wherein said depth of removal is controlled by providing a support member having an outer cross-sectional area adapted for supporting said vessel, and providing said output surface with a similar configuration as said support member but of a different cross-sectional area, whereby the thickness of said removed layer is substantially equal to the difference between said respective cross-sectional areas.
15. 14. A method as in claim 13 wherein: a. said support member cross-sectional area has a circular configuration, b. said output surface cross-sectional area of said tool member has a circular configuration, and c. said relative movement between said tool member and said support member is along the longitudinal axis of said support member, so as to substantially remove a circular layer of said material from said vessel.
16. 15. A method as in claim 1, wherein said material is of a relatively low fatigue strength relative to the fatigue strength of said vessel and said vibratory energy is applied for a time sufficient to effect fatigue fracture of said material to effect said disintegration and of any bond of the latter to said vessel.
17. 16. A method as in claim 1, wherein said step of supporting a portion of the wall of said vessel includes placing in said vessel a support member having a surface for engagement with and application of a radially oUtwardly directed force thereto, whereby said wall is supported along an axially extending portion.
18. 17. A method as in claim 16, including the step of supporting said wall along a length of said axially extended portion in the range of from 0.20 to 2 inches.
19. 18. A method as in claim 16, wherein said radially outwardly directed force is applied circumferentially to said wall along said axially extending portion.
20. 19. A method as in claim 1, wherein said output surface of said tool member is elliptically vibrated.
21. 20. A method as in claim 1, wherein said output surface of said tool member is torsionally vibrated.
22. 21. A method as in claim 1, wherein said output surface is vibrated with simultaneous longitudinal and torsional vibration.
23. 22. A method as in claim 1, wherein said tool output surface is vibrated in the frequency range of 10,000 to 100,000 cycles per second.
24. 23. A method as in claim 1, further including the step of maintaining said material at a temperature below which permanent damage would occur to the surrounding wall, said temperature being maintained by supplying a treatment liquid at a preselected temperature.
25. 24. A method as claimed in claim 1, wherein said vessel is a blood vessel.
26. 25. A method as in claim 24, wherein said material removed is cholesterol.
27. 26. A method as claimed in claim 24, wherein said blood vessel is an arterial.
28. 27. A method as claimed in claim 24, wherein said blood vessel is a veinule.
29. 28. A method as claimed in claim 24, wherein said blood vessel is an artery.
30. 29. A method as claimed in claim 24, wherein said blood vessel is a vein.
31. 30. A method as in claim 1; a. wherein said wall portion is supported by applying said internally outwardly directed force and forming one or more nibs of said material extending inwardly from said supported wall portion, and b. further including the step of maintaining said radial force during said relative movement of said tool member and said internally supported wall portion until said respective nibs are removed.
32. 31. A method as in claim 30, wherein said internally outwardly directed force is radially applied by inserting in said vessel a support member having a cross-sectional area adapted to apply said radial force to compress said material, said support member having a plurality of apertures adapted to receive said compressed material and form said nibs, and said relative movement is axially between said tool member and said vessel to remove said nibs.
33. 32. A method as in claim 1, wherein said portion of the wall of said vessel is supported by said tool member.
34. 33. A method of removing a layer of material adhered to the inner surface of a blood vessel in vivo, comprising the step of: a. providing an opening in a blood vessel, b. Internally axially supporting a portion of said vessel by inserting therein a support member having a contacting surface for engagement with and application of a radially outwardly directed force to support said portion of said blood vessel, said support member having an axially extending first passageway therethrough, c. inserting in said vessel through said first passageway a tool member having an output surface, d. supporting said tool member at one end of a transmission member extending through said first passageway and terminating at its opposite end exteriorly of said blood vessel, e. vibrating said tool member at an ultrasonic rate by transmitting mechanical elastic energy waves to said transmission member, f. mounting said transmission member in said first passageway to transmit a minimum of vibratory energy to said support member, g. placing the output surface of said vibrating member in contact with said material at substantially said internally axially supported wall portion so as to transmit said vibrations thereto for a time sufficient to effect disintegration of said contacted material, h. effecting relative movement of said tool mEmber and said vessel so as to progressively contact, disintegrate, and thereby remove said layer of material from within said blood vessel, i. supplying a treatment fluid through a second passageway to said supported portion adjacent said vibrating tool member for forming a suspension of said disintegrated material and treatment fluid, j. applying a suction force through a third passageway to said supported portion adjacent said tool member to remove said suspension from said blood vessel, and k. controlling the depth of removal of said material during the relative movement between said support member and said tool member.
35. 34. A method as in claim 33, further including the step of controlling the relative movement between said tool member and said vessel such that said output surface is maintained within said supported portion of said vessel
36. 35. A method as in claim 33: a. wherein said support member has a plurality of apertures extending between said contacting surface and said first passageway in the area of said supported portion, whereby said radially outwardly directed forces compresses said material and forms a plurality of nibs extending through said apertures and into said first passageway, and b. wherein said relative movement is axially in said first passageway, whereby said tool member engages and removes said nibs.
37. 36. Apparatus for removing a layer of material adhering to the inner surface of a vessel of a human in vivo, comprising a. means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed, b. a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface adapted for engagement with said material, c. vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member, d. means adapted for effecting engagement of the output surface of said tool member with said material at substantially said supported wall portion so as to transmit said vibrations thereto for effecting disintegration of said contacted material, e. means coupled to said tool member for effecting relative movement between said tool member and said means for internally supporting the vessel, wherein the output surface thereof is adapted to move within said supported wall portion, so as to progressively contact, disintegrate and thereby remove said layer of material from said vessel, and f. means for controlling the depth of removal of said layer of material, said means including means for maintaining said means for internally supporting the wall potion and said tool member output surface in relatively fixed spaced relation to each other to define a spacing therebetween for controlling the depth of removal.
38. 37. Apparatus as in claim 36, wherein said vibration generating means includes: a. a vibration generator, b. an ultrasonic motor connected to said vibration generator, and c. a transmission member coupling said ultrasonic motor to said tool member for transmitting said ultrasonic vibrations thereto.
39. 38. Apparatus as in claim 37, wherein said vibration generator includes means to continuously vary the frequency of vibration of said transmission member so as to vary the position of the loops and nodes of vibration therealong so as to prevent substantial heat buildup along said transmission member at any location thereon.
40. 39. Apparatus as in claim 37, wherein said means adopted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said wall portion of said vessel, and said transmission member extending through said pasSageway.
41. 40. Apparatus as in claim 39, further including radial support means maintaining said transmission member and support member in axially spaced relation to each other.
42. 41. Apparatus as in claim 40, wherein said radial support means includes a plurality of radially extending flanges in longitudinally spaced relation to each other along said transmission member.
43. 42. Apparatus as in claim 41, wherein said radial flanges are provided substantially at loops of longitudinal vibration along said transmission member.
44. 43. Apparatus as in claim 39, wherein said support member is provided with a plurality of radially inwardly extending flanges in said passageway to support said transmission member.
45. 44. Apparatus as in claim 39, wherein said means for effecting movement of said tool member relative to said means for internally supporting comprises said transmission member coupled to said tool member.
46. 45. Apparatus as in claim 36, further including means to limit the relative movement of said tool member relative to said support means, such that said tool member output surface is adapted to remain within said supported wall portion.
47. 46. Apparatus as in claim 36, further including means for removing the disintegrated material from said vessel.
48. 47. Apparatus as in claim 46, wherein said means for removing said disintegrated material includes suction means communicating with said vessel for removal of the disintegrated material therefrom.
49. 48. Apparatus as in clam 36, further including a. means for forming a fluidized suspension substantially at said supported wall portion containing the disintegrated material, which includes means for supplying a treatment fluid to said supported portion, and b. means for removing said fluidized suspension from the vessel so as to cave the supported wall portion substantially free of disintegrated material, said removing means including means adapted to communicate with said vessel for removal of said fluidized suspension therefrom.
50. 49. Apparatus as in claim 36, wherein: a. said means adapted for supporting the portion of said vessel includes a support member adapted to be inserted therein and having a passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted to support said portion of said vessel to provide a selected configuration of given internal cross-sectional area therein, and b. said tool member output surface having a similar configuration as said supported portion but of a different cross-sectional area, such that said depth of removal is equal to the difference between said respective cross-sectional areas.
51. 50. Apparatus as in claim 36: a. wherein said means adapted for supporting a portion of said vessel includes a tubular member having an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said supported portion and a first passageway extending axially therethrough with a plurality of apertures connecting said first passageway and said exterior surface, and b. said exterior surface adapted to provide a radially outward pressure to compress said material and effect a flow of said material through said apertures to form a plurality of nibs in said first passageway, such that said relative movement removes said nibs.
52. 51. Apparatus as in claim 50, including means for advancing said tool member axially through said first passageway to engage said nibs and remove them.
53. 52. Apparatus for removing a layer of material adhering to the inner surface of vessel a of a human in vivo, comprising: a. means adapted for internally supporting the wall portion of said vessel in the proximate area from which said layer of material is to be removed, said support means including a support member adapted to be inserted therein and having a first passageway extending therethrough with an axially extending peripheral surface at substantially one end thereof adapted tO support said wall portion of said vessel, b. a tool member movably supported within said means, said tool member adapted to be inserted within said vessel and having an output surface for engagement with said material, c. vibration generating means coupled to said tool member to effect vibration of the latter at a high frequency sufficient to cause disintegration of material in contact with the output surface of said tool member, said vibration generating means including
54. 53. Apparatus as in claim 52, wherein said tool member is vibrated in the range of 1,000 to 500,000 cycles per second.
55. 54. Apparatus as in claim 52: a. wherein said tool member is adapted for movement within said first passageway, b. wherein said support member has an annular exterior surface adapted for substantially complete engagement with the inner peripheral surface of said supported portion and a plurality of apertures connecting said first passageway and said exterior surface, and c. said exterior surface adapted to provide a radially outward pressure to compress said material and effect a flow of said material through said apertures to form a plurality of nibs in said first passageway, such that said relative movement of said tool member removes said nibs contained therein.

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