CA1280469C

CA1280469C - Method of and apparatus for laser treatment of body lumens

Info

Publication number: CA1280469C
Application number: CA000517645A
Authority: CA
Inventors: Kenneth R. Fox; A. Arthur Coster
Original assignee: Kenneth R. Fox; A. Arthur Coster; Fox-I Family Limited Partnership; Pillco Limited Partnership; Coster Family Limited Partnership; Interlase Limited Partnership; White Star Holdings Ltd.
Current assignee: WHITE STAR HOLDINGS Ltd
Priority date: 1985-09-05
Filing date: 1986-09-05
Publication date: 1991-02-19
Anticipated expiration: 2008-02-19
Also published as: EP0217165B1; DE3650463T2; US4784132A; US4784132B1; AU592376B2; JPH0724662B2; DE3650463D1; JPS63500987A; WO1987001273A1; AU6371886A; EP0217165A1; ATE132348T1

Abstract

ABSTRACT OF THE DISCLOSURE
A laser microsurgical method and apparatus are disclosed for safely treating occluded body lumens with laser energy. The disclosed method involves the use of pulsed laser energy from an argon-ion laser to destroy the tissue of luminal occlusions, such as atheromatous plaque and the like, with substantially no thermal necrosis of the surrounding tissue. A flexible catheter and associated laser microsurgical system is also disclosed which provides for aiming of the fibers to transmit the laser beam at the distal end of the catheter and rotational positioning of the catheter to permit coverage of virtually the entire cross-sectional area of the lumen. A lens system at the distal end of each laser fiber minimizes beam divergence and directs the beam toward the central axis of the catheter. A further embodiment of the catheter of the invention provides an array of laser fibers which are optically scanned with laser energy to cover the cross-sectional area of the lumen. The system is designed to minimize the possibility of damage to or perforation of the surrounding tissue of the lumen.

Description

6~

~ET~OD OF AND I~PPAR~TUS
FOI~ LASER TREATMENT OF BODY LUMEN~B

BAC~C~ROUND OF T~ VENTION
. .
The pxesent lnvention relat~ to ~ ~ethod of ana apparDtu~ ~Eor the las~r trea~ent o occluded bc)dy lumen~ o~ IRa~als, ~ lnlly hu~ nd ~aore -- ~rtleularly to th~ intrEIlu~lnal u~e o~
energy to p~rforatQ ~I/or a~ nal o~clu~ , 8uC~ a0t~ro}~i ~n~ r a~hers)sclerc)t~c plaoquee ln th~ ~raiova~ul~r oyste~10 Caral~ calar diseas~ 18 a ~a~or cau~e of death ~nd ~orbldity ~ ~1 fest~ ve CQlOern t~ both the ~cientifls: co~nunlty ~ndthe lay public. ~rter~o~cl~r~t~ c~rdlwascular pathophy~lology 1~ a comple~c of disea~es wl~
affect~ ~any blood ves~el~ ln ~1~ body, the decrea~ed lumen dia~eter a~u~ng ti88ue inche~ia.

6~3 Other very common diaeases, ~uch as diabetes mell ltu~, enhance the occlus ~ f ~mpor tant blood ve~s~l3 and ia~hemia of ~e organs they supply.
Thoa~ di~ea~e~, aggravated by ~uch other common 5 abnormallties as hyperten~ion, and other vascular di~eaRes and cardiovascular di~eases, account for cerebrovascular accidents, myocardial infarctions, and o~her deva~tating illnesses, including los of life and limb~ Unfortunate individuals af fected 10 with arterio~clerotic cardiovascular di~eases and the related va~culopa~hie~ often manife~t disease in cDronary, carotid and cerebral arteries, in popliteal, tibial and dorsalis pedis arteries of the lower extremeties and in other vesselR. Those 15 individualR, apart from having a shortened life expectancy, and ~uffering from sudden death, frequently also ~uffer from other debilitating problems including angina, shortness of brea~h and re~tricted activity, claudication or restricted use ~ of the lower extremities, ~ometimes with loss of those extremitie~ from disease, and loss of functions o~ movement, 8pe ech, cerebral interpretation and cogn~tive abilitie~.

Historically, there are few effective means : 25 for preventing some of the fore~oing disastrous medical problems. Patients with certain types of i coronary in~ufficiencies documented by certain coronary angio~raphic findings may be helEed ~ymptomatically by coronary artery bypass 30 operation~. Othex patient~ sometimes may be be~efit~d by other types of arterial surgery, for e2a~ple, various bypass operations, or endarterectomie3, which surgically attempt 3~69 r~canallzation of certain occluded blood ves~el~ or o~her op~rations. Those are generally patients with ~evere disease, but yet ~iho meet certain diagno3tic criteria and who are healthy enough to 5 under~o ~at amounts to ma~or surgery with relatively high morbidity and mortality rates. The co~t i8 immense for many of ~hes2 operations and incumbent hospitalization, including expensive special equipment which i8 r~quired, and special 10 training which is nacessary for a team to operate ~he special surgical e~uipmentO For example, it i8 estimated that a single coronary bypa~s operation may cost a patient over ~50,000 including the hospitalization fees, and surgical fees.
1~ Availabi3ity of this special type of surgery for vascular problems is limited. ~ong term efficacy of coronary bypass surgery is as yet unknown, and the appropriate diagnostic and surgical criteria re~ain controversial. Ebcause of the severity of the morphology and nature of the disease, for many ! patients treatment has been unavailable and has been bey~nd the current scope of surgical intervention. For example, many p~tients lose extremities or their lives by virtue of having these inoperable conditions.

In a different context, problems of lumen~
of the body, particularly small lumens, are oompli~ ted by occlu~ive diseases of other types.
As an example in ~he nervous system, the Aqueduct 30 of Sylvius, in the ventr icular sys1:em of the brain, ~ay be blo ~ed in a child born with congenital hydrocephalus. This condition necessitates a ccmplicated and often unsuccessful corrective neurosurgical prscedure known as ~hunting.
Con~idering the genito-urinary sy~tem, for example, fallopia~ tube~ may become occl~lded by inflammatory or o~her disease proce~es. This may cause 5 infertility and i8 a common pxoblem. There i8 no effective treatment for thi~ problem at this point in time, and this has stimulated interest in the "test tube baby" controYer~y.

One suggested solution to the pr~blem of 10 atherosclerotic obstxuctions i5 a non-operative technique to improve coronary blood flow known as percutaneous transluminal coronary angioplasty tPTCA). Generally, PTCA involves intr~ducing a balloon catheter into the femoral artery or by 15 brachial cutdown and fluorscopic positic~ing at the appropriate coronary ostium. Pressure monitoring is al~o used to aid in positioning the balloon tip o the catheter at the stenQsis. The ballooon is inflated for 3-5 seconds to mec~anically enlarge 20 the stenosis and is then deflated ~or measurement of distal coronary pressure. The cycle may be repeated several times until a satisfactory decrease in pressure gradient is achieved.

Although the PTCA technique is sometimes effective to improve coronary blood flow, there are oomplications which must be weighed before unaertaking the ~rocedure. Such complications whi~h may occur include arterial spasms, myocardial 30 infarctians thrombotic occlusion, embolization and dissection, or frank perforation of the vessel wall.

It has also been suggested that 6~3 cardiovascular occlusions, as well as o~clusione in o t~er body lumen3, mi ~h t be vapor iz ed by means of continuou~ wave ( CW) laser energy. U.S. Patent ND.
4, 207,874 to Choy, for e~ca:rple, disclos~ a 5 flexible corlduit which accommodates a fiberoptic bundle divided into light source, viewing and la~er bundle portions. The flexible conduit i~ ;
introduced into a vein or other body lumen and advanced u~til it contacts an obstruction ~uch as a 10 thrombus. A la3er apparatus optically a~ociated with the laser fiber bundle is ~hen activated 50 that the laæer energy vaporizes the obstruction, the remaining particles of which are then removed by suction.

Other ~lexible laser endoscopes for u~e in the therapeutic laser treatment of body lumens are disclosed in U.S. Patent No. 4,072,147; 4,1~6,019;
4,170,997; and German Offenlegungsschrift No.

2,640,406. Such intraluminal laser device~
20 typically are said to function by thermal vaporization and/or coagulation of the luminal obstruction mass.

One of the most serious risks inherent in the intraluminal use of laser radiation, especially 25 in coronary or cerebral blood vessels, is the possibility of perforation of or thermal damage to the vessel walls and surroundin~ tissue. i, Accordingly, intravascular recanali~ation of occluded blood vessels is still an experimental 30 procedure.

Recently~ investi ga tors have reported the -` ~1 2~

use of continuous wave (CW) argon, neodymium-YAG
and carbon dioxide la~er source~ to ~ucce~afully vaporize~, coagulate and penetrate athero~clerotic placque in animals and in ~ections of coronary 5 arterie~ taken from human cadavers. However, the inve~tigator~ al80 report perforation of the vessel wall~ in many case~, par~icularly at laser energy levels which have been increa~ed to a level sufficient to effect vaporization of the placque.

Such laser energy levels are appropriately ~haracterized as ~he "thermal" mode of laser oEeration which involves cau~ing damage to tissue by virtue of heat accumulation in the tis~ue impin~ed by the laser radiation. Excessive heat 15 accumulativn causes thermal degradation or thermal necrosis. In other words, the temperature of the tissue ri~es, tissue proteins are denatured and ulti~3tely the tissue is coagulated and "evapor~ted" or "vaporized." While the laser 20 ~hermal energy mode is effective in coagulating and vaporizing many tissues, including the tissues forming atherosclerotic plaoques and stenoses, it~
u~e heretofore in occluded coronary and cerebral blood vessels, for e~ample, is not sufficiently 25 ~afe and controllable. Consequently, the problem of inadvertent damage to or destruction of surrounding ve~el tissue has ~een a major o~stacle in the development of an acceptable microsurgical techni~ue for laser angioplasty in ~he human 30 vascular sy~em.

Apart from the risk of using oontinuous wave (CW) laser energy in the human vascular 5y8tem, ~he 6~3 , prior art intralu~inal las~r device~ lack effective mechanis~æ for "aiming" the laser beam to minimize ~he po~ibility of inadvertent damage to the vessel wall~ and to ~a~imize the expo~ure of a lar g area 5 of the occluæion, e.g., ~he ar~herosclerotic placque, to the laser energy.

S UMM ARY AND OB JE CTS O F THE IN VE~T IO~
In view of the foregoing limitations and shortcomings of ~he priox art intraluminal laser 10 devices, as well as other disadvantages not specifically mentioned above, it should be apparent that ~here still exist~ a need in the art f~r a laser microsurgical apparatus for use in coronary angioplasty which is capable of effecting 15 recanalization of occluded coronary and cerebral blood vessels at minimum risk of perforation or thermal necroæis of the ves~el wall~. It i~, therefore, a primary objective of this invention to fulfill that need by providing a noYel coronary 20 arterial catheter and associated laser micro~urgical system and a method of using the same whereby the laser energy radiated wi~hin the cardiovascular system is carefully controlled and aimed in such a way as to effectively destroy or 25 penetrate athero~clerotic plaoque, yet minimize the risk of vascular perforation or ~hermal necr~sis of the surrounding tis~ue.

Pbr e par ti a~ lar ly, i t i8 an object of the present invention to provide an effective method of 30 delivering laser energy in a saf~, ~ubætantially non-heat conducting or con~uction-free mode by controlling the pulse wndth or duration, p~lse repetitiorA rate, an~l duty cycle of the laser energy wi th in pr ede ter min ed r ange ~ and by U8 in g opt i ca 1 switching to sequentially direct ~e laqer energy at sslected target areas.

S I~c i anol~her sb ject o ~e present invention to provide a flexible cat~heter adapted to be inserted into a body lumen~ 8uc~h a~ an ob~truc:ted cor~nary artery, ~aid ca~eter having one or more quartz gla88 laser fibers whi~h can be 10 "aimed" at a particulax target within a target area comprisin~ s~stantially the entire cross-sectional area of the body lumen.

Yet anotiher o~ject o~ the invention is to provide a laser microsurgical ~ystem connected to 15 the proximal end of a flexible angiographic cat~heter for controlling the positioning, illumination, vi~ualization, firing and analysis ., functions of the sy~tem.

Still ano~er ob ject of ~e invention is to 20 pro~ide a flexible angiogra~ic catheter for use in occluded blood vessels i~l combination wit~ laser micro~urgical apparatus, 3aid catheter having one or ~ore laser fibers, each o~ whi~h is provided wi tll a lens system whi ch minimizes divergence of 25 ~he laser beam ~d prismati~lly cants the laser beam toward ~he center of t~he blood vessel to intensify the cutting effect of ~e beam ana to minimize ~he po58i~ility of perforation of ~he vessel walls .

Another object of the invention is to provide a fle~ible catheter adapted to be inserted into a body lumen and having a plurality of laser fibers di~posed within the catheter, such fibers being selectively scanned with laser ener~y by an 5 opti~al ~canner to "aim" the laser energy at a particular target area in the overall cros~-~ectional area of the body lumen.

~ riefly described, the aforementioned dbjects o$ the invention are accompli~hed according 10 ~o its apparatus aspects by providing a flexible catheter having an outside diameter from about 1.2 to about 5.0 millimeters, which is especially suitable for use in coronary, cerebral and somewhat larger carotid blood vessels, for exa mpl e, to 1~ remove occlusions, such as atheromatous plaoque.
Wi~hin the catheter sheath ~here are provided a plurality of optical fibers and ~luid channels.

In one embodiment of ~he invention, the optical fibers include a bundle of laser 20 transmitting fibers eccentrioally arranged relative to ~he catheter axis and radially movable toward that axis by means o a balloon positioned within the catheter sheath~ Each laser fiber has a distal lens system which converges and cants the radiation 25 beam away from the circumference of the catheter and toward the axis thereof. Alternate embodiments of ~he catheter include distal lens systems for ~he laser fiber~ which may comprise one or more diverging lenses for special applications or 30 techniques to be hereinafter described.

A flexible optical fiber viewing element with a di~tal lens system i~ provided within the catheter sheath which oDmpriee3 a plural~ty of individual fibers having a gla s cladding and extending over a sub~tantial pE~rt of the 5 cross-~ectional area of ~he ca~heter, for in~tance, ~0% or more . l~n illuminating 8y8tem compr is ing several individual pla3tic clad quartz glas3 fibers cooperatee with the optical viewing element and is arranged adjaeent thereto :Eor delivering white 10 light from a conventional light sourceO

Fluid ~ystems within the catheter include an outflow or suction channel for removal of fluids and debri~ and two or more inflow channels for injection of saline, p~armacologic agents, 15 radiopaque positioning dyes, immuno-specific antibodies and the like. Carbon dioxide gas channels are also provided for inflation/deflation of both the laser aiming balloon and a balloon circumferentially disposed about the catheter 20 adjacent the distal end thereof for occluding the vascular lumen and for e~tablishing stabilization of the ca~heter distal end relative to said lumen.

A laser microsurgical ~y~tem i8 operatively connected to the proximal end of ~he flexible 25 angiograEhic ca~heter and comprises ~ proxi~al optical and fluid coupler for interc~nnecting the optical fibers and fluid channels of the catheter to the various system compo~ents, ~uch as the laser apparatus and control, laser fiber optical scanner, 30 illumination and vi3ualization systems, po~itioning systems and fluid system~.

6~

The bb~eCtB of the invention are acoomplished according to its method aspect~ by the use of vi3ible l~ght laser energy in the wavelength range of 351 to 515 nanometers, and, preferably, S ~he blue-green emission line-Q at wavelength~ of 4~8 and 514 nanometers from an argon-ion laser with a peak power output of about ~0 watts, ~uch as a ~pectra-Physic3 171 La 8 er. The argon la 8 er apparatus i8 operated in the pul~ed or 10 non-conducting mode using a pulse wid h or duration in the range of from S to 200 milliseconds and a pul~e repetition rate of 1 to 50 pulses per seoond with a dty cycle of between 5 and 50%. The preferred pulse energy is in the range of from 150 to 500 millijoules. Spot ~ize for each fiber in the laser fiber bundle may be from 100 to 500 microns, pre~erably, the largest possible spot size in that range compatible with energy density r~quirements.

The above parameters of the pulsed laser energy are selected to effect damage to a luminal obstruction with sub~tantially no thermal n~crosis of ~he surrounding tissue. A hole iB drilled in the obstruction by heating a given volume of the tisgue thereof to it~ boiling point and then supplying the heat of vaporization ~o that volume to ~onvert it to vapor. Ideally, the total laser energy ~eeded to vaporize the given volume of ~he ~i~sue of ~he obstruction is delivered in such a short period of time that heat conduction to the currounding tissuP is negligible. That time period is defined as the "thermal time constant" or "~hermal relaxation time" for the given vol~me of tis~ueO According to the invention, the pu13 charact~ristics, ~.g., pulse width, pulse repetition rate and energy, are ael~cted to operate in the co~duction-free mode, that i~, the laser 5 energy i~ preferably delivered just at ~he threshold of ~h2 thermal relaxation time of the illumina~ed volume of the obstruction tissue.

Experimental result~ have indicated that over the range of laser ~ocal diameter~ of 50 to 10 100 micron~ for an argDn-ion la~er, the diameter of the laser drilled hole in artexial plao~ue i~
approximately 500 microns, i.e., 5 to 10 times greater ~han ~he laser focal diameter. That phenomenon is believed to be the result of a 15 combination of strong, small angle scattering and weak absorption of the plaoque tissue. l~e larger area, and consequent larger volume, of illuminated tissue results in a greater energy threshold for drilling the plaoque, that is, a greater ~h~rmal 20 inFut is necessary because of the scattering of the laser light and the absorption characteristi~s of the placqu~. For the argon-ion laser, the energy threshold i8 about 200 millijoules per pulse over a pulse width of 200 milli~econds or less.

An alternate embodiment of the i~ven~io"
takes advantage of the foregoing experimental re~ults by locating a plurality of la~er fib~rg in a flexible catheter in an array wi~h the laser fibers appropriately spaced to provide 30 substantially complete coveragc of the cross-sectional area of a body lumen or ve~sel-with~
little or no overlapping of the drilled laser hole. Thu~, "al~lnq" ~y be acccmpli~hed by opti~lly scanning t~e plurality of laser fibers to - impinge la~er ~nergy on selected target areas, e.g., ~ plurality of tarqet ~reE~s, each having a 5 5 00 mi cr on d i ame ter, ov er t::he en t ir e cross-sectional area confronting the distal end of ~e catheter. Optical scanning of the laser fibers in a predetermined E~equence al80 permits a greater nu~iber of pulse~ or "3hots" to be made in a given 10 time period wi~out e~ceeding the energy ~hre~hold and cau~ ing thermal necroe i8 of the surrounding tis~ue. Th2 laser fibers dispc>sed adjacent the outermost periphery of the catheter may also be "skewed" toward the center of the catl eter to 15 minimize l~he po~s ibility of per foration of the luminal wall.

Wi th the foregoing and other ob jects, advantages and features of the invention t::hat will become hereinafter apparent, the nature of the 20 invention ~ay be more clearly understood by reference to the following detailed description of l~he invention, t~he appended claim~, and to the several views illustrated in the attached drawings.

BR IEF D lES CRI Pr IO~ O F THE DRAW IN GS
Figure 1 i8 a transverse cross-sectional view of a firs~ e~odimen~ of ~he fle2ible catheter of ~he pre~e~t invention taken along line 1-1 of Pi~ure 2:

Figure 2 i~ a longitudinal cross-sectional 30 YieW, partly broken, of the firs~ e~ibodiment of ~he cat~eter of the invention taken along line 2-2 of E'igure l;

~a~3~6~3 Figures 3A 3B are transverse cros0-~ectional V~ W8 0imilar to E~gure 1 ~how~ng the poaitioning o~
the laser ~iber bundle:

Figure 4 1~ a view ~llustra~ing the 5 po~itionirlg of the di~tal end of the catheter in a bs:~dy lumen adjacent a partial occlusion of ~he lumen:

Figure 5 i~ a 0c~he~atic block diagram showlng the la~er microsurgical ~ys e~ of the present invention:

1~ Figure 6 iB a transver~e cross-~ectional view of the distal end o~ an alternate e~ibodiment of the iElexible ca1:heter of the present invention, taken along line 7-7 of Figure 6; and Figure 7 i8 a longitudinal cross-~ectional 15 view of ~he catheter of Figure 6 taken along line 7-7 showing skewing of l~he outermost la~er fibern.

DETAILED DESCRIPrIO~ OF A PE~EEERRED EMBODIME~T
.
Re~Eerring na~ in ~etail to the drawings ~erein t~he same part~ are des~ gnated by the same 20 refererace numeral~ throughout~ ~here i~ illustrated in Figures 1 and 2 cros~-sectional details of the di~tal end of the inventive flexible ca~eter which i8 de~i~ated generally by reference numeral 10.

The ~at:heter lO aompri~es a plaBtlc Gheath 12 ~lch ~ay be a non-to~1c polyvinyld~loride (PVC) or other su~tab1e non-toa~lc pl~tic material. The outslde diameter of the ca~heter lO for use in the S la~er coronary angiopl~ty te~hnique~ de~cribed herein ~e fro~ about 1.2 to abs:~ut 5.0 mill~meter~, but may be larger in d~amter for u~e in other, larger body lumen~.

Di~posea wi thin the catheter shea~ about th~
0 ~en~cral ~i8 14 t:hereo are a plurality of elements extending long~tudinal:Ly of the catheter and, for convenience of ~lluRtration, are shown in ~igures 1 and 3A-3D a~ being somewhat 1008ely disp~sed in spaced relation to one ano~her. In the actual 15 construction of the catheter, the element~ are in closer pro~imity to c~e another ~an shown in the drawings to pravide a 00mewhat yreater packing aensity con~i~tent with the requlre~ent ~or shift~n the la~er fiber bundle relative to the catheter as~i 20 in the manner de~cribed hereinafter.

~ la~er ~ber b~ndle lfi in arranged eccentrically oiE the c~th~ter al~ L8 14 and, in a preferred form, Qompri~es ~our quart~ glas~ laser fibern l~a-18d for tran~mitt~ng the laser energy, 25 each fibOE hav~ng a core diameter of rom SC~ to 20 micron~. Lager fiber~ 18a-18d are enibedded in a laminated ~heath or claading 20 of ncn-to~i c polyethylene or PVC. As shown în Eigure 1, the fc la~OE fibers are preferably cxr thogonally arranged 30 with the a~se~ of two of ~he fiber~ 18a and 18c di~6ed al a radial plane ~roug~ t:he catheter a 14 .

An elonga te balloon 22 i8 bonded or otherwi~e af fi xed to the circumference of the la~er fiber bundle 16 at the portion thereof proximate ~he catheter ~heath 12 and extend~ parallel to the 5 a~i~ of the la~er fiber bundle a~ shown in Figure 2. Inflation of the balloon 22 exer tB a radially ;nward force on the laser bundle 16 tending to urge ~he same toward the ~atheter axi~ 14 and thereby "aiming" the laser energy as more fully described 10 hereinaf~er in connection wi~h Figures 3A-3D.

Arranged at the lowermo~t portion of the catheter, a8 viewed in ~gure 1, iB a visualization opt;cal element 24 which i~ of generally cDnventional construction. Opti~l viewing element 15 24 i6 generally crescen~-shaped in cro~s-section and comprises a plurality of S,OOO to 10,000 individual gla~s fiber~ 26, each having a he~agonal cross-section to improve the packing factor. lq~e fiber~ 26 each have a flat-to-flat dimension of 20 about 4 micron9 and are packed tightly together and fused only at their pro~imal and distal ends to pre~ ~ve~fle~ib~lity. The bundle of fiber~ i8 enshea~hed in a gla88 cladding 28 and a lens system 30 (Figure 2) of known ccnfigurat~on, i.e., two 25 plano-conve~ lenses, i8 fused to the distal end of the viewing element 24 ~r praviding wiae angle vi~ualization within ~he bo~y lumen.

Illumination of ~he ~urgical area i6 30 provided by three fused quartz glass fibers 32, 34, 36 of about 50 micrc~ns diameter which are clad with a PVC sheath 38. As shown 1r~ Figure 1, the :'' ~L~ 80 L~6 ~9 illuminating fi~ers are preferably arrang~d tantially dia~etrically for ~ost effective illumination of the central portion of the body lumen .

The fluid systems of ~e ca~heter, in addition to ~he laser fiber aimin~ balloon 22, include a suction channel 40 and two inflow channels 42, 44. Th~ ~uction channel 40 i~ used for debris removal and for suctioning fluid3 from 10 t~e intraluminal region at ~he distal end of the catheter. Inflow channels 42, 44 are employed for injecting fluids such as saline, Fharmacologic agents, radiopaque positioning dyes and immuno-specific antibodies, among others.

A conventional circumferential balloon 43 is arranged about the catheter 10 adjacent ~he distal end thereof as shown in Figure 4. Inflation of balloon 43 occludes flow in the lumen L and establishes a fi xed, stabiliY.ed position of the 20 distal end of the ca~heter 10. Such balloons and the methods and apparatus ~or inflating and deflating the same are well-known in the art and, therefore, need not be described in greater detai1 herein.

As shown in Figure 2, at *he distal end of each laser fiber 18a-18d, there i~ epD~ied a ; converging lens 46 ~r ~ocusing ~he laser energy beam and preventing undesirable divergence toward the luminal wall and a prism 48 for bending or "canting" the eccentric laser bea~ from each fiber toward the center of ~he lumen. qbtal divergence ~213~

angle of the preferred 100-500 micron diam~ter Bpot for each fiber i~ preferably no greater than S.
Preferably, the optical axeR of the prismatically canted la~er beama are maintained in parallel 5 relation~hip to prevent spot "overlap" and beam divergence.

In certain circumstances, it may be de~irable to in~ert a catheter with a laser fiber bundle having a diverging lens sy~tem at the end of 10 each laser fibex. For instance, if the di~tal end of the catheter directly abut~ an occlusion of atheromatous plaoque, a ~reater laser impact area could be achieved with a diverging len~
arrangement. After destruction of the first few 15 millimeters of the placque is ac~omplished, the catheter would normally ~e replaced by a catheter having the converging lens system shown in Figure 2.

With reference now to Figures 3A-3D, Figure 3A corresponds substantially to Fi~ure 1 and shows 20 the balloon 22 in it~ deflated condition with the la~er fiber bundle in it~ most eccentric radial position in relation to the central axis 14 of the catheter~ As the balloon 22 is gradually inflated, the la~er fibex bundle is incrementally urged 25 substantially radially toward the axis 14 until it rea~h~ a position of minimum ec~entricity as shown in Eigure 3B.

Figures 3C and 3D illustrate ~he same conditions of inflation/deflation of balloon 22 as 30 shown in Eigures 3A and 3B, respectively, except ~hat ~he catheter 10 has been roated exactly 180.

6~3 It will be understood by those skill2d ln the art that by the appropr~ate selection of angla of rotatio~ o the catheter and inçremental inflation/deflation of balloon 22, the four 200 5 micron spQts from the laser fiber8 18a-18d ~an be po~itioned to impinge at any target area over virtually the entlre cross-~ectional area of the body lumen being treated.

Referring now to Figure 4, the di~tal end of 10 the ca~heter 10 iB shown fi~ed in position in a lumen L adjacent a partial occlusion X. The uppermost pair of diverging dot~ed line~ represents a laser energy beam B from las~ fiber 18a when said fiber is positioned on a vertical ~lane at a 15 location of greatest eccentricity from the catheter axis. Beam B has a total divergence angle 50 of 5: however, because the beam has been prismatically canted by the lens system 46, 48 shown in Figure 2, the diverging beam does not 20 impinge on the wall of the lumen L, but rather i8 directed toward the centxal portion of the lumen L. Likewise, the lowermost pair of diverging dotted lines in Figure 4 represent~ a la~er energy beam B' from laser fiber 18a when said fiber i8 25 positioned exactly 180 from the po~ition at which beam B wa~ generated. Beam B' also has a total divergence angle 52 of 5 as ~h~wn in ~ gure 4.

It should be ap~arent from the foregoing description of F~gures 3A~3D and Figure 4 that the laser energy beams transm;tted by the la~er fiber bun~le 16 of ~he catheter are not only capable of b2ing "aimea" at virtually any target area within ~he lu~en, but are coslv~rged and canted 80 as to minimize the poa~ibility of la~er beam impingement on ~he lu~en wall a .

Po3itioning o~ the ~istal end of the cathe'cer 10 i~ aided by known radiogra~ihic vi~ualiz~tion procedures9 For this purpose, it i~
advalltaqeous to mark t~he peri~hery of the distal end of ~he catheter wi~h a plurality of radiopaque strips 54) 56, 58 of predetermined size and po~itioned for determining both the rotational and axial po~itions of the catheter within a coronary artery, for e~ample.

The laser microsurgical system 60 of the 15 invention i~ shown ~chematically in Figure 5. The 5y3tem 60 includes a laser source 62 which i~
pre ferably an argon-ion laser, such as a Spectra-Physics 171 kase~r for gene.ratin~ a pulsed la er beam. The output of laser source 62 is a 20 pulsed la~er beam 64 whis~h i8 inputted to a multi-fiber optical scanner ~6 of a known type, for exa~ple, of l:he type described by Fujii et al in Applied Optic~, Vol. 21, ~ib. 19, pp. 3437-3442, OctobQr 1, 1982. Scanner 6~ i~ used to scan the 25 four laE~er ~Eibers 18a-18d o~E the las~r fiber bundle 16 wil~h pulsed laser beam 64.

Control of pulse width or duration, pulse repetitio~ rate, wavelength, len~th of e~posllre, inten~ity and ~iring is provided by a laser control 30 68 a~30ciated wit~ the l~ser source 62. Firing of ~he laser 62 i8 acc~mpli~ ed by closing a firing ~wltch 69 which may be, fQr example, a fcot pedal switch.

The proximal end of the optical ~isualization element 24 supplieR an optical image S to a viewing microscope 70 which has a built-in eyepiece shutter medhanism 720 The shutter 72 i~
responBive to activation of the la~er source 62 to prevent back-scatter of laser energy which could damage the surgeon's eyes.

The optical imagP from optical element 24 i8 also supplied to an imase analyzer 74 controlled by miCrOprOCes-QOr 76 both of which are used to analyze the visual images transmitted frvm the intraluminal region at the distal end oP the cat~eter and to aid 15 in longitudinal positioning of the catheter distal end, "aiming" o the laser fiber or fibers at the appropriate target in the intraluminal region and -timing of the laser ~iring signal in relation to the cardiac cycle. A suitable microprocessor and 20 image analyzer is a Videoplan Computerized Image Analyzer available fro~ Carl Zeiss, Inc., 444 Fifth Avenue, New York, ~ew York 10018.

A conventional cathode ray tube video diRplay 78 and video rec~rder 80 are connected to 25 the image analyzer for real time observation and recording, if desired, of the microsurgical procedure.

An i 1 luminati on sour ce 82 is connected to the proximal ends of optical fibers 32, 34, 36 for 30 delivery of white light thereto. The light is 3~9 pr~vid~d by ~oercury or x~non hi~jh pre~ure ~rc lamps within quartz ~n~lol~ures: however, other type~ of llght sour~e~ ~ay be u~ed. A vacuum unit B4 ~nd fluid~ ~nput unlt 86 are connected to the 5 ~uction dlannel 40 and fluid inflow line~ 42, 44, respe ctively .

For in1ation and deflation of the aiming balloon 22 and circumferential balloon 43, a fluid p~es3ure souroe 88~ ~u~h as pre~suri~ed carbsn 10 dio~cide, i~ connected ~hrc~ugh respective electrically~perable solenoid valve~ 90, 92 to the pneunatic tubes 94, 96 supplying the aim~ng balloon 22 and the cira~mferenti~l balloon 43, respectiv3~1y.

l'he pro3cimal end of the ca theter 10 i8 15 mounted in an axial and rotatiorlal drive mec~hani~m 98 which rotates ~he oat~heter about its axis and move~ the ~ame a~cially in re~ponse to me~ al or elec tri cal 8i gnal 8 from a mi cromani pula tor 100 whi~h, in turn, rec~eives command signals from the ~0 microproce~or 76. 8uitable micropwitioners are well-knc~wn in the ar t ~nd are available rom numerou~ ~o~Lrce~, ~uch ~8 Rlinger ~:cientlfic Ca~poration, 110-120 ~amaica Avenue, Ric~hmond Hill, New York 11148.

It is also a~ar~tageow3 to synchronize the occlusion of the coronary artery wi~h ~he balloon 43 and the ~i~ing of the la~er 62 wi~ t;he cardiac cycle . G~ era lly, i t ~ ~ des ir abl e to in f la te th e 30 ~a~heter balloon 43 auring ~he filling phase o~ the cardiac cycle and deflate the balloon during the ~804G9 pumplng ~hase of ~he cardiac cycle. In that way, blood flow i9 occluded under minimal pressur~
conditions in the coronary artery. For this purpc~se, a convsntional coun~erpul~ator 102 ~ay be 5 used which ~enses ventricular output with an aortic catheter independently of the catheter 10 of the invention. one ~uitable counterpulsator ~ known as System 82 and iR manufactur~d by Data~cope Corporation, 580 Winter~ Avenue, Paramus, New 10 Jersey 07652.

An alternative or seo2nd embodiment of the ca~h~ter of the invention i8 ~hown in Figure 6 and identified with reference numeral 110. The 15 ~atheter 110 compri~e6 a plastic ~heath 112 similar to the sheath 12 of the Figure 1 or first e~bodiment of the invention, the out~ide diameter of which i~ preferably fro~ about 1.2 to about 5.0 millimeters for use in the described laser ~oronary 20 angioplasty techniques. The Figure 6 embodiment illustrates a catheter having an outside diameter of about 1~5 millileters which diameter i8 ~sentially defined by the arrangement of the la-Rer fiber array d~spo~ed within the sheath 112 as 25 explained in greater detail hereinafter.

A plurality of elements similar to those illu~trated in Figures 1 and 2 are arranged to extend longitudinally within the sheath 112 about the longitudinal a~is 114 thereof and, like the 30 ~howing of Figure 1, are ~omewhat loosely disposed in relation to one another, although in actual practice the element~ are packed in clo~er 34~

pro~imity, prefer~bly in a fixed relationsh1p to one another and ts:~ the sheath 112.

The catheter 110 has a similar arrangement of optical viewing elemen'c 124, illumination fiber~
5 132, 134, 136, suction channel 140 and inflow channels 142, 144 a~ the first embodiment of the invention. However~ in contrast to the laser fiber bundle 16 of the fir~t embodiment o~ ~he inYention~
individually clad las@r fiber~ 118 of ~he second 10 embodiment are disp~ed abou~ ~he catheter a~is 114 in a predetermined, parallel array de igned to provide impingement of laser energy on substantially the entire cross-~ectional ar~a of an ob~ruction confronted by the catheter 110 wqth little or no 15 overlapping of laser impingement.

Inasmuch as experiments have indicate~ that drilled holes with an argon-ion laser have a diameter of about 500 microns resardles3 of laser focal diameter, an array of seven ( 7) 50 to 200 20 micron diameter fibers 118 in ~he arrangement ~hown in ~ gure 6 will provide laser energy coverage of virtually the entire cros~-~ectional area of a luminal obstruction confronting t~he catheter 110, particularly in ~he central region thereof a~ shown 25 by the dashed line areas 116 of laser impingement.
Advantageously, ~he large~t areas 120 not included in ~he total laser impingem~nt area are looated at the outermost periphery of the ca~heter adjacen~
the vessel walls where laser eneryy impingement i8 30 lea~t desirable, and, in $act3 may b~ detrimental.

In view of ihe ~ave tea~hings, variou~

arrange~ents of laBer fibers for different diameter cathe1:ers will be apparent to tho~e st~illed in the art. For example, the ~ame ~ev~n ( 7~ fiber array ~ay be used ~or a 102 ~illimetsr diameter catheter 5 by arranging the c~nter~ of ~he laser fibers a a 400 ~icron ~pacing rather than the 500 micron ~pacing ~hown in Figure 6. While a certain amount of la~er impingement overlap will result from that arrangement, by appropr~ate scanning of the laser ; 10 fiber~ wi~h laser energy any overheating of the ti~ue can be avoided.

~ enerally speaking, a laser fiber disposed on ~he a~is 114 of the catheter i8 preferred, but i9 not essential. Thuso although a 1.2 millimeter 15 diameter catheter iB preferably provided with an array of 5 to 7 laser fibers, an array of four (4) laser fiber~ equiangularly spaced may be provided with their i~pingement areas in tang~ntial relationship. While ~uch an arrangement would not 20 provide la3er impingement in the central region of an ob~truction confronting the catheter, de~truction of the obstruction surrounding the central region will eli~inate support of such central region and ultimately cause it to gravitate 25 to a laser impingement area where it will be destroy2d, In larg~r diame~er catheters~ a larger number of la~er fi~ers are preferably employed.
~br instance~ a 5.0 millimeter diameter ~atheter 30 enccmpa~ses an area 100 time~ greater ~han the 500 micron diameter area impinged by a single laser fiber. Therefore, an array of 80 to 100 la~er s~

fiber~ would be required to cover the entire area ~onfrQnted by a 5~0 ~illimeter diameter catheter.

The laaer microsurgical sy~tem 60 shown schematically in Figure 5 may al60 be used with the S ~e~ond embodiment of the catheter 110 of the invention shown in Figure 6. A~vantageously, the multi-fiber optical ~canner 66 may be programmed to scan each of the laser fibers 118 with pulsed la~er energy in a preselecte~ sequence. The scanning 0 9eqUenCe i8 preferably ~elected to operate in the conduction-free or non-heat conducting mode~ In that way, the po~sibility of overheating and the co~se~uent ~hermal necro~is of a given impingement area is avoided, while at the same time the number 15 of pulses of laser energy that can be delivered to ~he impingement area in a given time period is maximized.

Although the laser fibers 118 of the second embodiment of the invention are de~cribed above as 20 extending parallel to the catheter axis 11~, a~
shown in Figure 7, the distal ends of the outermost laser fibers may al80 be inclined or ~kewed inwardly toward the catheter axis by an angular amount id~ntified by reference numeral 122. The 25 amount of skewing may amount to between 5 and 45. Preferably, ~he distal ends of ~he laser fibers 118 are inserted or molded into an end plate 126 fixed o ~he shea~h 1120 The end plate 126 may also rsceive ~he other longitudinally extending element~ ~f the catheter~ such as the viewing element 124, illumination fibers 132, 134, 136 and fluid channels 140, 142, 144.

- ~8~ 9 q~he above-described ~kewing o the per iEjheral la~er fiber 8 advantageously cau~eQ the outermo~t la~er energy bea~s to conv~rge toward the axi~ of ~h¢ boæy lumen or vessel and thereby 5 pr~vide fur1~her protectic~n again~t the pos~ibility of per~oration of the luminal wall. Such ~kewing, how~ver, reduce~ the total area of laser illuminatlon of a given diameter of catheter and axxangement of laser fibers and result~ in varying 10 degrees of la~er beam overlap depending on the distance between the obstru tion and the distal end of the ca theter .

~ t would be possible to skew the di~tal ends of some of ~he interiorly disposed laser fibers of 15 an array having fiber groups disposed at varying radial distances from the axis of the catheter.
Such skewing may cause the axes of the fibers to diverge or converge wi~h the catheter axis so as to achieve overlapping of laser impingement if desired 20 or to "aim" at areas not impinged by ~he laser beam or blind ~pots caused by the positioning of other element~ in the catheter, ~uch as the elements 124, 132t 134, 136, 142, 144, etc.

Accordin~ to the method of the present invention, laser energy i~ not supplied as continuous wave (CW) laser energy in the thermal mode to vap~rize atheromatous occlusions as in the prior art, but rather as pulses of 5-200 milliseo~nd duration at a p~lse repetition rate of 1-50 pulses per ~econd and a duty cycle of between 5 and 50~. The pulse energy is from 150 ~o 500 millijoules. The laser 30urce 62 is an argonion la3er del iver ing 20 watt~ peak power at wavelengths of about 488 and 514 nanometer~ and a preferred spot size vf about 100-500 micron~ diameter.
Pul~ing of the las~ ~ource in the ranges described 5 above has been advantageou~ly found to be both ~afe and effective; ~afe from the standpoint that the vessel wall~ will neither be perforated nor slibjected to thexmal necrosi~, and effective from the standpoint that ~he laser energy i8 10 ~ufficiently great to effect vaporization of the occlusion.

The selection of 8pe Ci fic values ~or the pulse duration, pul~e repetition rate, pulse ~ergy-parameters within the aforesaid ranges to effect 15 destruction of an occlusion without thermal necrosis i9 dependent to a large extent on the thermal time constant and absorption characteristics of particular type or material of the occlusion, e.g., fibrin, cholesterol, calcium, 20 oollagen, low-density lipoproteins and the lilce.
Based on the teachings herein, however, one Qkilled in the ~rt can xeadily select a suitable value for each pulse parameter to effect condu~tion-free operation, i.e., destruction of the tissue of the 25 occlusion with substantially no ther~al necrosis of ~he surrounding tissue.

Although only preferred embodiments are specifically illustrated and describ~d herein, it will be appreciated that many modifi~tions and 30 variations o the presen~ invention are possible in light of the above teachings and wi~hin the pur.view of the appended claims wi thout departing from the spirit and intended scope of the invention.

Claims

1. Apparatus for performing laser surgery in a body lumen having an obstruction therein comprising laser source means for generating a laser beam having predetermined characteristics for effecting damage to the obstruction in the body lumen, at least one optical fiber means for transmitting the laser beam from said laser source means to the obstruction, the improvement comprising said optical fiber means including a plurality of optical fibers and an optical scanning means for scanning said fibers with the laser beam such that damage is effected to the obstruction with substantially no thermal necrosis of the surrounding tissue of the body lumen.

2. The improvement according to claim 1, wherein said laser beam is a non-continuous wave, pulsed laser beam having a predetermined pulse duration, pulse repetition rate, pulse energy and duty cycle selected to operate substantially at or near the threshold of the thermal relaxation time of the irradiated volume of the obstruction.

3. The improvement according to claim 2, wherein said laser beam has a wavelength in the range of about 351 to 515 nanometers.

4. The improvement according to claim 3, wherein said laser source is an argon-ion laser with a pulsed argon-ion laser beam having a pulse duration in the range from 5 to 200 milliseconds, a pulse repetition rate in the range from about 1 to 50 pulses per second, a pulse energy in the range from about 150 to 500 millijoules and a duty cycle of 50% or less.

5. The improvement according to claim 4, wherein said pulsed argon-ion laser beam has a spot size of 500 microns or less.

6. The improvement according to claim 1, including a catheter having a longitudinal axis, said plurality of optical fibers having proximal and distal ends, said fibers being arranged in said catheter in a predetermined array about the longitudinal axis of the catheter, said optical scanning means being arranged to optically scan the proximal ends of the optical fibers with the laser beam so as to impinge the laser beam on a plurality of different areas of the obstruction.

7. The improvement according to claim 6, including aiming means for shifting the distal ends of said fibers relative to the longitudinal axis of the catheter.

8. The improvement according to claim 7, wherein said aiming means comprises a balloon and means for inflating and deflating said balloon such that said fibers are shifted substantially radially of the axis of said catheter whereby said laser beam is selectively aimed to impinge upon different points on said obstruction with substantially no movement of said catheter relative to the body lumen.

9. The improvement according to claim 7, including means for rotating said catheter about the longitudinal axis thereof.

10. The improvement according to claim 9, wherein said fibers are arranged eccentrically relative to the longitudinal axis of the catheter.

11. The improvement according to claim 6, wherein the distal ends of some of said optical fibers are converged radially inwardly at an angle toward the longitudinal axis of the catheter.

12. The improvement according to claim 6, including lens means disposed at the distal ends of said fibers, said lens means comprising a converging lens for converging said laser beam and a prism for canting said laser beam toward the longitudinal axis of said catheter.

13. The improvement according to claim 6, including a circumferential balloon arranged about the catheter and means for inflating and deflating said circumferential balloon in synchronism with the cardiac cycle of the person on whom the laser surgery is being performed.

14. The improvement according to claim 1, wherein said laser surgery is laser angioplasty and said body lumen is the cardiovascular system of a human body.

15. Apparatus for performing laser surgery in a body lumen comprising:
catheter means for insertion in a body lumen, said catheter means having a sheath and a longitudinal axis and proximal and distal ends, at least one fiber means arranged in said catheter means for transmitting a beam of laser energy from said proximal end to said distal end to impinge upon an obstruction in said body lumen;
laser means arranged adjacent the proximal end of said catheter means for generating a non-continuous wave, pulsed laser beam having a predetermined pulse duration, pulse repetition rate, pulse energy and duty cycle selected to effect damage to the obstruction with substantially no thermal necrosis of the surrounding tissue;
aiming means arranged within the sheath of said catheter means for shifting the distal end of said fiber means relative to said sheath and the longitudinal axis of the catheter means whereby said laser beam is selectively aimed to impinge upondifferent points in said obstruction.

16. Apparatus according to claim 15, including means for rotating said catheter means about the longitudinal axis thereof.