CA2200917A1 - Lateral and posterior aspects method and apparatus for laser assisted transmyocardial revascularization and other surgical applications - Google Patents

Abstract

A balloon end contact scope device for performing laser-assisted transmyocardial revascularization (TMR) or other surgical and catheter procedures, the device particularly adapted for delivery of laser energy via a laser delivery means and configured to reach inside a body cavity or organ chamber at a point not directly accessible, either visually or otherwise, such as in a lateral or posterior position, the device having a hollow outer lumen, balloon scope portion with an internal guide tube extending through the balloon portion for directing a laser delivery means or other surgical or catheter device through the visualization balloon toward the area being visualized. The balloon scope portion may have a plurality of guide holes extending therethrough. On the essentially transparent contact viewing surface a high friction surface may be applied to facilitate precise positioning and treatment therethrough. The device can be used for attaching a guide tether for placing marking devices or fluoroscopic locators, or for placing other interventional devices. A method of visualizing and treating the heart, other organs and internal parts of the human body comprising the following steps: prividing a balloon end contact scope with a main lumen and an essentially transparent contact viewing portion of a predetermined size and material of construction and integral laser delivery means or other equipment channel suitable for viewing the heart other organs and internal parts of the human body; precisely positioning the contact viewing portion in contact with a portion of the heart, other organ or internal body part adjacent the position to be viewed; and visualizing the heart, other organ or internal body part. The method can be used to place a guide wire or tether to the heart, other organ or internal body part in order to locate a nuoroscopic or other visualization means or to perform additional visualization, fluoroscopic marking or other interventional procedure. The method also comprises the step of delivering laser energy to a portion of the heart to effect transmyocardial revascularization. The method can be performed either by surgically introducing a balloon end viewing scope into the chest cavity of a patient and through the pericardial sac of the heart to a position between the pericardial sac and the epicardial surface of the heart or by introducing a balloon end viewing scope into the vasculature of a patient, for example at a point on the femoral artery, and into an internal chamber of the heart.

Description

I;IELD OI; THE INVENTION
The present invention relates to the surgical proccdurc known as laser-assisted transmyocardial rcvascularization CI MR), and morc particularly, to improvcd mcthods and apparaluses for preciscly positioning a fiber-optic or other wavcguidc adj3ccnt the arca or arcas to be lased, including at positions adjacent the posterior 20 epicardial and endocardial surfaces of the hcart and at trans-septal positions within the chambers of the heart, thercby making possible the creation of channcls in myocardial tissue at precisely the positions in the heart where ischemia or infarction or olher havc rcnderc~ such trcatmcnt desirable or necessary. These methods and apparatuses can be adaptcd for use in surgical applications throughollt the human body or in animals for tr:lnsmittinf~ laser energy prccisely, at prcdetermined positions and to predetPrrnined depths.

BACKGROUND OF TI-IE INVENTION
FIG. 1 is a schematic view of the human heart. The hurnan heart 10 is a mll~cul~r dual pump that beats continuously throughout life sending blood to the lungs and the rest of the body. The interior of the heart consists 2 ~

of four dis~irlct chambcrs. Thc septum 12, a thick central m~ r wall, divides the cavity into right and lcft halYes. On the right side, the upper haIf Is know~ as the right a~num 14. Deoxygenated blood from ~he roet of the body aITives in the righ~ atrium via the vena ca~ra 16, the blood is pumped across a one-way valve knowll as the .
tricuspid valYe 18 into the lower portion Icnown as thc right ventricle 20. From there the blood circulates to the s ~rough the pulmonary valve 22 Yia the pion~y artery 24 wbere it is oxygenated by circul~on through the alveoli of ~e lungs (not shown). The blood returns via the pulmonary veins to the le~ a~iusn t6 and flo~s rough a second valYe, the rnitral valve 28 into the leP~ ventricle 30 wherc it is p~lmped via thc aorta 32 to the rest of the body.
Much ofthe heart corlsists of a special type of muscle called m~oc~di~,l. The myocardium req~ s a con ~t~nt supply of oxygcn and nùtrients to allow it to conb act and purnp blood throughout dle v~s~ n-re~ I he ir~er surfaces of the ch~rnbers of the healt are lined wi~h a smooth membrane, the endocardium, aud dle cntire heart is enclosed in a tough, mcmbranous bag known as tbe pericardial sac.
The p~nping action of the heart has thr~e maun phases for each heart beat. Diastole is dhe res~ng phase du~ing which the heasl fills wi~ blood: v hile dcoxygen~ted blood is enlering the right atriurn o~rgc~cd blood is LS ret~Tled ~om the lungs to the le~ atnum. Dunng the arrial sys~o~e, ~he ~o atria con~act ~imlllt~n~o~lsly, squeezing thc blood in~o the lower vcn~icles~ Finally, dunn~ ventriculor ~ys-ole ~he YentnCIoe cont~ to pumE! the deoxyg~nated blood mto the pulmon~ry artencs and thc oxyga ~ted blood into thc ~ aor~a When dle heart is ~mpty, dtastole begins a~ain. Th~ electric;~l impulses which stimul~to thc heart to cont~ct in this manner enlanate ~om the heart's own pacernak~, thc suloatn~l node. The h~art rate is undcr the extemal control of ~e body's 20 autonomic nerl~ous sysrem.
FIG. 2 is a srh~m~tic view ofthe coronaIy arteries on the outer surface o~the huma~n hear~ Though the he:~rt ~pplies blood t~ all other pa~s of the body, Ihe heart itself has relatively little co.. I ~i~tjo~ with the oxygenated blood supply. Thus, the two U~lU~ arteries, thc leP~ coroL~y arte~y 40 a~ld the right coronary artery 42 which arise ~om Ihe aorta and encircle ~hc heart muscle on e,ther side "li,ke a crown" to supply the ~eart itself page 2 with blood.
Heart disorders are a common causc of death in developed countries. They also impair the quality of life of millions of people restricting activity by causing pain, breathlessness, fatigue, fainting spells and anxiety. The major cause of heart dise;lse in developed countries is impaired blood supply. The coronary arteries, which supply S blood to the heart, become narrowed due to afllerosclerosis and part of the heart muscle are deprive of oxygen an other nutrients. The resulting iscflemia or blockage can lead to angina pec~oris, a pain in the chest, arms or jaw due to a lack of oxygen to the hcart, or infarc~ion, death of an area of the myocardium caused by the iscJlemia.
Techniques to supplement the flow of oxygenated blood directly from the left ventricle into the myoc~rdial tissue have included nccdle acupuncturc to crcate transmural ch~nn- lc (see below) and implantation of 10 T-shaped tubes into the myocardium. Efforts to graft the omentum, parietal pericardium, or me~ stin~l fat to the surface of the heart had limited success. Others a~tr mpted to restore arterial flow by implanting the left internal r artery into the myocardium.
Modernly, coronary artery blockage can be relieved in a number of ways. Drug therapy, inr,llldine nitrates, beta-blockers, and peripheral vasodilator drugs (to dilate the arteries) or thrombolytic drugs (to dissolve the clot) 15 can be very effectivc. If drug treatment fails tr~nclnmin:-l angioplasty is often inriir~ed - the narrowed part of the artery, clogged with atherosclerotic plaque or other deposits, can be stretched apart by passing a balloon to the site and gently inflating it a ccrtain degrce. In the event drug therapy is ineffective or angioplasty is too risky (often introduction Or a balloon in an occlulle(l artery can causc portions of the atherosclcrotic material to become dislodged which may cause a total blockage at a point dou/nstream of the subject occlusion thereby requiring 20 emergency procedures), the procedure known as coronary artery bypass grafling (CABG) may be in(lir~ted CABG is the most comrnon and successful major heart operation performed, in Alrierica alone over 500,000 procedurcs being performed annually. Thc procedurc takes at least two ~ geolls and can last up to five hours. First , the surgeon makes an incision down the center of the patient s chest and the heart is exposed by opening the pericardium. A length of vein is removed from another part of tlle body, typically the leg. The patient is connected P~ge 3 to a heart-lung machine which takes ovcr the function of the heart and lungs during thc operation. The scction of vein is first scwn to the aorta and then sewn onto ~ coronary ~rtery at a place such that oxygenated blood can flow directly into the heart. The patient is then closed. Not only does the procedure require the installation of the heart-hmg machine, a very risky procedurc, but the stcmum must be sawed through and the risk of inrection is ~nhqnced 5 during the time the chest cavity is spread open.
Anothcr method of improving myocardial blood supply is called transmyocardial revasa~larization (TMR), the crcation of channels fiom the epicardial to the endocardi;ll portions of the hcart. The procedure using needles in a form of "myocardial acupuncture" has becn experimented with at least as early as the 1 930s and used clinically since the 1960s. Deckelbaum. L.I., Cardiovascular Applications of Laser technology, Lasers in Surge)y and Medicine 15:315-341 (1994). The technique was said to relieve i~hPmiq by allowing blood to pass from the ventricle through the ch~nnels either directly into other vcssels perforated by the chaMels or into myocardial sinusoids which coMect to the myocardial microcirculation. The procedure has been likened to tr~qncforrning the hurnan heart into one rescmbling that of a reptile.
In the reptile heart, perfusion occurs via comm~ni~qting channels between the left ventricle and the 15 coronary arteries. I;razier7 O.H., Myocardial Rcvq~c~lqri7q~ion with Laser- Preliminary Findings, Circl-lalion, 1995; 92 [suppl II]:II-58-II-65. There is evidcnce of these comm~nicq~inr7 channels in the developing human embryo. In t~1e human heart, myocardial microanatomy involves the presence of myocardial sinusoids. These sinusoidal communica~ions vary in si%c ;md slmclurc, but rcprcscnt a nctwork of direct artcrial-luminal, arterial-arterial, arterial-venous, and vcnous-luminal coMcctions. This vascular mesh forms an important source of 20 myocardial blood supply in reptiles but its role in humans is poorly understood.
Numerous studies have been performed on TMR using lasers to bore holes in the myocardium. The exact mcrh~ni~m by which blood flows into thc myocardiurn is not well understood however. In one study, 20-30 channelsper square centimeter were bored into the le~ v~ntric~lqr myocardium of dogs prior to occl~ nn of P~e 4 the arteries. LAD ligation was conductcd on both the reV~cul~ri7f d animals as well as a set of control animals.
Results showed that animals having undergone TMR prior to LAD ligation acutely showed no evidence of ischemia or infarction in contrast to thc control animals. Aftcr sacrifice of the animals at ages bctween 4 weeks and S months, the lascr-crc.~tcd channcls could be dcmonstrated grossly and microscopically to be open and S free of debris and scarring.
It is belicved that the TMR channels occlude toward ~he epicardial surface but that their subendocardial section remains patent (unobstructed) and establishcs carnerosinusoidal connections. It is possible that the creation of laser channcls in thc myocardium may promote long-terrn changes that could ~ rnf n~ myocardial blood ilow such as by inducing angiogenesis in the region of the lased (and thus darnaged) myocardium.
10 Support of this possibility is rcportcd in histological evidencc of probable new vessel forrnation adjacent to collagen occluded transmyocardial rh:~nn~ In the case of myocardial acupuncture or boring, which m~rh~nic~lly displaces or removes tissue, acute thrombosis followed by org~ni7~tion and fibrosis of clots is the principal m~rh~ni~m of channel closure. By contrast, histological evidence of patent, endotheliurn-lined tracts within the laser-created channels supports the assumption that the inside of the laser ch~nnel~ is or can become 15 hemocomratible and that it resists occlusion caused by thrombo-activation and/or fibrosis. A thin zone of charring occurs on the periphery of the laser-created transmyocardial ch:~nnPl~ through the well-known th~nal effects of optical radiation on cardiovascular tissue. This type of interface may inhibit the immediate activation or~c inlrinsic clol~ing mcch.misms bccausc of ~hc inhcrcnl hemocompatibility of carbon. In addition, the prccisc cutting ac~ion that results from thc high absorption and low scattering of laser encrgy tCO2, HO, etc.) 20 may minimi?e structural damage to collateral tissue, thus limiting the tissue thromboplastin-rne~ ted activation of the extTinsic coagulation. . -U.S.PatentNo.4,658,817issuedApr.21, 1987toHardyteachesamethodanda~pa~t~sforTM~' using a la"ser. A surgical CO2 laser includes a handpiece for directing a laser bearn to a desired loc~tion P~ge 5 Mounted on the forward end of the handpiecc is a hollow needle to be used in surgic~l applic~hons where the needle perforated a portion of tissue to provide the laser beam direct access to distal tissue.
U.S. Patent No. S,125,926 issued Jun. 30, 1992 to Rudl;o ct al. teaches a heart-synchronized pulsed lascr systcm for TMR. The device and metl1od comprises a device for sensing the contraction and expansion of S a beating he;lrt. As the heart beat is monitored, the device triggers a pulse of laser energy to be delivered to the heart during a predetermined portion of the heartbeat cycle. This heart-synchronized pulsed laser system is important wherc the type of laser, the energy and pulse rate are potentially rl~rn~ging to the beating heart or it's action. Often, application Or laser cnergy to a beating he~rt can induce fibrillation or arrhythmia. Additionally, as the heart beats, it's spatial relationship betwcen the heart and the tip of the laser delivery probe may change 10 so that the necessary power of the bearn and the required position of the handpiece may be unpredictable.
Finally, U.S. Patent Nos. 5,3~0,3l6 issued Jan. l0, 1995 and 5, 389,096 issued ~eb. 14, 1995 both to Aita et al. teach systems and methods for intra-operative and percutaneous myocardial reva~cnl~ri7~hon, respectively. The forrner patent is related to TMI~ performed by inserting a portion of an elongated flexible lasing apparatus into the chest cavity of a patient and lasing ~h~nnPIs directly through the outer surface of the 15 epicardium into the myocardium tissue. In the latter, TMR is performed by guiding an elongated flexible lasing apparatus into a paticnt's v~scula~lrc such that the finng cnd of the apparatus is adjacent the endocardium~and lasing channcls dircctly lhrough the cndocardium into the myocardiurn tissue without perforating the pcricar(lium laycr. Thcsc patcnts do not tcacl1 any mclhod ror conlrolling the clon~ated ncxible laser delivery apparatus, nor do thcy tcach mcthods of visualizing the areas of the heart being lased nor do they teach any 20 method or devices for achieving TMR on surfaces or portions of the heart which are not directly accçssible via a sternotomy, mini-stcrnotomy or via a trocar. .
TMR is most oftcn used to treat the lower left chamber of the heart. The lower chambers or ventricles are servic~ed by the more distal hr~nr~hps of the coronary arteries. Distal coronary arteries are more prone to blockage and resulting heart muscle damage. Roughly 50% of the left ventricle is direct line accessible through a thoracotomy or small incision between the ribs. ~Iowever, roughly 50% is not direct line acceccihle and requires either rotating the heart or sliding around to the back side of the heart. Access to the heart is achieved by (1) sliding a devicc between the heart ~nd pcricardial sack wllich encases the heart, the device likely to have a 45-90 degrcc bcnd ncar the tip, (2) lif~ing the still be~ting hcart, and (3) pcnctr~ting through the direct access side of the heart and/or through the septum of the heart. Lining the still beating hcart is less than desirable especially in patients with lowered heart perfonn~ncf ~urthcrmore, such manipulation can cause tachycardia (rapid beating of the heart absent undue exertion) fibrillation, arrhythr,ua or other interruptions in the normal beating cycle.
Thus, broa(lly, it is an object of ~he present invention to provide an improved method and device for laser-assisted TMR
It is a further object of the present invention to provide an improved method and device for laser-assisted TMR in which the procedure may be carried out from within the interior of the heart and in which visualization or positioning of the laser delivery means is done by improved means.
1~ It is a further object of the present invention to provide an improved method and device for laser-assisted TMR in which the procedure may be carricd out on rear surfaces and other visually hidden exterr,~l surfaces of the heart and in which vi~u~ tion or positioning of the laser delivery means is done by improved mc;ms.
It is a further object of the present invention to provide an improved method and device for laser-assisted TMR in which the need for visualiz;ltion during the procedure is minimi7ed by employing a depth stop, such as a mesh basket or "moly bolt" device adjacent the end of the elongated flexible laser delivery means, to position the distal end of the laser delivery means It, is a further object of the present invention to provide an improved method and device for laser-assisted TMR in which the distal end of the elongated flexible laser delivery means eoln~lises a known vi.~ i7~on system with an adj~mct vicl~li7~tion device to enhance the quality of the visualized image.
It is a further objcct of the present invention to provide an improved method and device for laser-assisted TMR in which the need for visualization dur.ing the procedure is minimi7ed by deploying a m~ ~h~nif~l S or other tether coupled to the heart at a point adjacent to the area to be revascularized, thereby conveying the distal end of the laser delivery means to that area and m~int~ining it in a predetermined position during the creation of channels witl~in ~he tissue of the myocardium.

SUMMARY OF T~IE INVENTION
A balloon end contact scope device for performing laser-assisted transmyoeardial rev~cnl~ri7~tion (TMR) or other surgical and catheter procedures, the deviee particularly adapted for delivery of laser energy via a laser delivery means and configured to reach inside a body eavity or organ chamber at a point not directly accessible, either visually or otherwise, such as in a lateral or posterior position, the device particularly adapted for use in conjunction with a vi.~ 1i7~tion means, the deviee eomprising a hollow outer lumen, the outer lumen 15 having a proximal end and a distal end, the outer lumen suitable for eonveying a surgical deviee such as for laser delivery or visu~li7~tion. The deviee has a balloon seope portion, the balloon seope portion attaehed~ta the distal end of the device, the balloon scope portion eomprising an essentially transparent eontaet viewing portion, a main body portion, tlle maill body porlion disposed between the eontaet viewing portion and the distal end of the outer lurnen and attached to the distal end of the outer lurnen, the ~tt~.l.",~ i between the 20 main body portion, the contact viewing portion and the distal end of the outer lumen sealed to prevent introduction of lluids into the balloon seope portion, and a guide tube, the guide tube having a proximal end and a distal end, the distal end of the guide tube attaehed to the eontaet viewing portion and po.~itioned sueh I that it extends longitudinally toward the distal end of the outer lurnen, the proximal end of the g ude tube r~8e 8 2 ~

positioned to receive the distal end of a surgical or catheter device extending through the outer lumen, the g ude suitable for conveying a surgical or catheter devicc through the balloon scope portion to the surface of the tissue being vi~ i7~ d through the contact vicwing portion. In a preferred embodiment the outer lumen is rigid. In a prefcrrcd embodirncnt thc outcr lumen is llcxible. In a preferre(l embodiment there is an inner lurnen, the inner S lumcn having a proximal cnd and a distal end, thc proximal end Or the guide tube being attached to the distal end of thc inner lumcn such that a surgical or catheter devicc can extend through the inner lu nen through the guide tube through the balloon scope portion to the surface of the tissue being v~ li7~d through the contact viewing portion. In a preferred embodirncnt there is a plurality of guide tubes, the guide tubes having proximal ends and distal ends, the distal ends of the guidc tubcs aKached to the contact viewing portion and positioned 10 such that they extend longitl1(1in~11y toward the distal end of the outer lumen, the proximal ends of the g ude tubes positioned to receive the distal end of a surgical or catheter devices extenl~ing through the device, the guides suitable for conveying the surgical or catheter devices through the balloon scope portion to the surface of the tissue being visualizcd through the contact viewing portion. In a preferred embodiment there is a plurality of inner lumens, the inner lumcns having proximal ends and distal ends, the proximal ends of the 15 guide tubes being attached to the distal ends of the inner lumens such that surgical or catheter devices can extend through the inner lumens of the device through the guide tubes through the balloon scope portion-to ~he surface of the tissue being vi~ 1i7ed through the contact viewing portion. In a prefcrred embodiment there is a lascr dclivery mc;ms, thc laser dclivcry mcans cxtcnding through the outcr lurnen of the device and through the guide tube of the balloon scope portion for delivery of laser energy to the surface of the tissue being visualized 20 through the contact viewing portion. In a prefcrred embodiment there is a plurality of laser delivery means, the laser delivery means extending through the outer lumen of the device and through the plurality of guide tubes of the balloon scopc portion for dclivery of laser energy to the surface of the tissue being visualized through the ' contact v~ewing portion. In a preferred embodiment there is a vi~ 1i7~tion means. In a preferred embodiment P~ge 9 there is an inflating means, the innating means suitable for introducing a suitable fluid such as air into the main body portion of the balloon scope portion. In a preferred embodiment the contact viewing portion of the balloon scope portion comprises a central high friction surface area and an pcripheral low friction surface area, the central high friction surface area immedi~tely adjacent to tlle attachment point between the distal end of the S guide tubc and thc contact vicwing portion, the low friction surfacc area disposed on the peripheral portions of the contact viewing portion such that when the balloon scope portion has a relatively low intemal pressure the peripheral low friction surface area will come into contact with the tissue being visualized or treated and when the balloon scope portion has a relatively higher internal pressure thc central high friction surface area of the contact viewing portion will comc into contact with the tissue being vicu~1i7Pd or treated. A preferred 10 embodiment is adaptcd for usc as a surgical instrument. A preferred embodiment is adapted for use as a catheter instlument.
A iluoroscope locator and guude tcther device for use as a fluoroscopic marker or locator as well as a guide tether for a monorail or other mounted-type fluoroscopic marking tools and m~teri~lc, laser delivery means, visu~li7~tion mean and other surgical equipment which can be positioned precisely along the guide 15 tether adjaccnt tissue to be inspected or treated, thereby prcserving spatial references in relation to the subject tissue, the device comprising a guide tethcr portion, the guide tether portion having a proximal end and a distal cnd and a predetermincd Icngth, thc guidc tether portion hav~ng a strength and thickness suitable for conveying Iluoroscopic marking tools and materials, lascr dclivcry means, vi~ li7~tion means and other surgical equipment along it's length, and a securing means, the securing means for securing the proximal end of the 20 guide tcther portion ortl1c dcvicc to tissue or othcr structure adjacent the subject tissue being vicu~li7~d~
marked or otherwise trcated. In a preferred embodiment the securing means is a suction cup. In a preferred embodiment the securing means is a tether clip. In a preferred embodiment the g ude tether portion is made of a ' rigid material. In a prererred embodiment the guide tether portion is made of a flexible m~t~ l In a preferred P~ge 10 embodiment there is a laser delivery means, thc laser delivery means having a distal delivery end and capable of delivcring laser energy in a predeterrnined bcam position and paKem, the laser delivery means mounted on thc guide tcther portion of the devicc such that thc guidc tethcr portion acts as a monorail for convcying the distal dclivery end of the lascr delivery mcans to points adjacent thc tissue or other structure being inspected or S otherwise opcrated on. In a prcferrcd cmbodimcnt the lascr delivery means comprises a plurality of filber optic cables. In a preferred embodimcnt there is a vacuum source, the vacuum source connected to the securing means, thereby m~int~ining the securing means aKachcd to tissue or other structure by a vacuum seal. A
preferred embodiment is adaptcd for use as a surgical instrument. A preferred embodiment is adapted for use as a cathetcr instrument.
A method of visualizing and treating thc heart, other organs and intcmal parts of the human body cornpricing the following stcps: (a) providing a balloon end contact scope with a main lurnen and an eccPnt~:llly ll~ls~dl;c.,t contact viewing portion of a predet~rninl d sizc and material of consL~ ;tion and integral laser delivery means or other equipment channel suitable for viewing the heart, other organs and internal parts of the hurnan body; (b) preciscly positioning the contact viewing portion in contact with a portion of the heart, other 15 organ or internal body part adjaccnt the position to be viewed; and (c) visl-~li7ing the heart, other organ or internal body part. In a preferrcd embodiment the following step is included: (d) att~ching a guide wire o'r~ether to thc heart, othcr organ or intcrnal body part in ordcr to locate a fluoroscopic or other vicu~li7~hon means or to perform additional visualization, nuoroscopic marking or olhcr interventional plOCedUIe. In a preferred embodiment the portion of the heart, other organ or mternal body part to be vicu~li7~ d or treated is on a lateral 20 or postcrior location on the heart, organ or other body part not directly visible or accessible via open surgery and other less-invasive techniques. In a preferred embodiment the following step is included: (e) delivering laser energy to the portion of the heart, other organ or intemal body part to be treated via a laser delivery means introduce~ through the main lumen of the balloon end viewing scope. In a preferred embodiment the laser P~gc 1 1 2 ~

energy is delivered to the heart to effect transrnyocardial revasculari_ation. In a preferred embodiment step (b) is carried out by surgically placing the balloon end contact scope through an opening in the pericardial sac and adjacent thc cpicardi~l surface. In a prefcrrcd embodiment step (b) is carried out by placing the balloon end contact scope into the v~scu1~h~re of the paticnt and into an inner chamber of the heart.
S A method of performing lascr-assistcd transmyocardial revasculari~tion CI'~), the method utili_ing a balloon end viewing scope with a central outer lumen to enhance vic~ i7~tion of surfaces being vic~ i7Pd or otherwise treated, the scope devicc h~ving a means for delivering laser energy to the region being vi~ li7çrl, the method compri~ing the following steps: (a) surgically introducing a balloon end viewing scope into the chest cavity of a patient and through the pericardial sac of the heart to a position between the pericardial sac and the epicardial surface of the heart; (b) prccisely positioning the balloon end viewing scope adjacent an area of the epicardial surface from which revacc~ ri7:-tion is to be ini~ te-l, the precise positioning achieved through the use of ~ visualization means disposed within the balloon end viewing scope, vis~ 7~tion achieved through the transparent or partially transparent waIls of the balloon structure pressed against the epicardial surface; (c) positioning the distal end of a lascr delivcry means through the cent~al lumcn adjacent the area of the epicardial surface from which revascularization is to be ini~i~1e~; and (d) delivering a controlled amount of laser energy directly onto thc cpicardial surfacc to crcatc a T~ channel Pxten-~inE therethrough into the myocardiu~n tissue. In a prefcrred cmbodirncnt ~he portions of the heart to be revascularized are located on the lateral and postcrior sidcs of tllC hc~t.
A method of performing laser-assisted trans-myocardial rev~scularization CI'MR), the method utili~ing a balloon end viewing scopc with a ccntral outer lumen to enhance vi~u;~1i7~tion of surfaces being vi-cl~li7ed or otherwise treated, the scope device having a means for delivering laser energy to the region-being vi~-~1i7P~l, the method c-)mrri~ing the following steps: (a) introducing a balloon end viewing scope into the v~c~ t~re of ' a patient, for exarnple at a point on the fernoral artery, and into an internal chamber of the heart; (b) precisely P~ge 12 2 ~

positioning the balloon end viewing scope adjacent an area of the endocardium surface from which revascularization is to be initiated, the precise posilioning achieved through the use of a vic-~1i7~tion means disposed within the balloon end viewing scope, visl~li7~tion achieved through the tl~-s~ l or partially transparent walls of ~he balloon structure pressed against the endocardiurn surface; (c) positioning the distal end of a laser delivery means through the cent~l lumen adjacent the area of the endocardium surface from which revasculari~tion is to be initiated; and (d) delivering a controlled amount of laser energy directly onto the endocardiurn surface to create a TMR channel extending therethrough into the myocardiurn tissue.
Numerous other advantages and features of the present invention will become readily apparent from the following dctailed description of the invention and the embodiments thereof, from the claims and from the acco, ~ ,p~--ying drawings in which the details of the invention are fully and completely disclosed as a part of this specification.

Br~IEI; DESCRIPTION OF THE DRAWINGS
FIG. l is a schematic view of the human heart.
FIG. 2 is a schematic view of the coronary arteries on the outer surface of the human heart.
FIG. 3 is a cross scction view Or lhe human hcart demonstrating a preferred method of TIvlR frorn~he pericardium of the present invention.
FIG. 4 is a cross scction view of lhe human heart demonstrating a prererred metho(l of TMR from the endocardium of the prescnt invention.
I;IG. 5~ is a schcmatic view of a preferred embodiment of a balloon end contact scope of the present invention.
FIG. SB is a detail view of a balloon end contact scope of the present invention.
~IG. SC is a detail view of a balloon end contact scope of the present invention.

FIG. 6 is a graphic representation of the various components of assembly of a preferred embodiment of a balloon end contact scope of the present invention.
FIG. 7 is a schematic view of a preferred embodiment of the interface between a balloon end contact scope Or the present invention an(l a lumcn tip housing the distal end of a laser delivery means and a 5 vis~ tion scope.
FIG. 8 is a schematic view Or a preferred embodiment of a balloon end contact scope having a pattrrning device built into the tip of the balloon of the present invention.
FIG. 9 is a srhrm~tic view of a preferred embodirnent of a suction cup-type fluoroscope locator and guide tether of the present invention.
FIG. 10 is a schematic view of the method of operation of a preferred embodiment of a suction cup-type iluoroscope locator and guide tether in conjunction with a dye swab advance mech~nicm, a l~ser delivery means advance merh:lni~m, a balloon fill and evacuate built-in syringe mer~h~ni~m and vi~u~ tion aid of the present invention.
FIG. 11 is a schematic view of a preferred embodirnent of a suction cup-type nuoroscopc locator and 15 guide tether in conjunction with a catheter device of the present invention having a plurality of laser delivery means extending thererrom of the present invention.
FIG. 12 is a graphical representation ofthe beam pattem and channels created by a catheter device with a plurality of lascr delivcry means extending thererrom.
I~IG. 13 is a sr,hrrn~tic view of a preferred embodiment of a lateral aspect positioning deviee of the 20 present invention for use with fluoroscope locators and guide tethers.
FIG. 14 is a srh~m~tic view of the method of operation of a preferred embodiment of a fluoroscope locator and guide tether in conjunction with a monorail-type mount surgical or catheter device of t-h-e present ' invention.

P~8e 14 2 ~

FIG. 15 is a schematic view of a preferred embodiment of a gwdc tether clip of the present invention having surface coining.
I~IG. 16 is a schcmatic view of a prcfcrrcd embodiment of a guide tether and clip of the present invention.

DETAILED DESCRIPTION Ol~ THE PREFERRED EMBODIMENT
FIG. 3 is a cross section view of the human heart demonctr~tin~ a preferred method of TMR in which access to the heart is gaincd by sliding the surgical device behveen the exterior surface of the heart and the pericardial sac cont~inine the heart. As is well known in surgical methodology, the heart can be ~ccPssed 10 externally via a m-ini-stemotomy perhaps with the use of a trocar or some othcr insertion tube device. The field ' of micro-surgery is advancing rapidly and small sophi~ti~ted tools can be introduced into the chest cavity through some type of catheter device. The device could contain a vi~ i7~tion probe, such as a 2-millim~t~
:'iber bundle, a laser delivery means, and other accc~olies including a dye swab, guide tether, ilhlmin~tion, etc.

In this drawing, the surgical device 50 is inserted through a trocar device 52 into the thoracic cavity between the ribs 54 of the patient. An incision 55 is made in the pericardial sac 56 and the surgical device is inserted therethrough. The balloon scopc portion 5~ is positioned adjacent the epicardial surface 58 of the heart. The surgical device would havc a malleable stainless steel outer lumen 60. Inside the pericardial sac there is no blood in lhc spacc bc~wccn lhc pcricar(lial sac and ~hc llcart, howcvcr, the balloon still acts as a sliding surface and provides a suitablc stand off distance for scope ~eld of view. Thus, pushing blood out of the way is not a 20 problem in this application, but hol~ling thc peric~rdium up like a tent is. The laser delivery means 62, optionally fiber optic or other waveguide, or other interventional or non-interventional surgical or catheter device would extend through with the balloon scope portion. As the laser energy is delivered to the adjacent epicardial surfacc, micro-rh~nn~l~ 64 arc produced in the surface of the epicardium, cl~t~ndin~ into the P;18e 15 2 ~

myocardium tissue and through thc intcrior cndocardium surface of thc chambcr in front of the lascr beam.
The handle 66 of the surgical or catheter device is located at the proximal 68 end of the outer lumen. A
laser delivery means advance lever 70 is located on and integral with thc handle. Any means for controlling the fiber in a prcdctcrmined, prcciscly controllablc manncr will bc uscful and will bc known to those skilled in the S art. Thc lascr dclivcry mcans advance mcans could also bc located scparatcly from the handle. A balloon inflation and deflation line 72 also attachcs to thc handle. Thc laser dclivery means cnters the surgical or catheter device. Visu~li7~tion mcans includcs a 2 millimeter fiber bundle 74 or other suitable scope, coMected to a camera 76, which is introduced to the outer lumen of the surgical or catheter device . A video monitor 78 is useful for providing real-time images or other images as the procedure is taking place.
The surgical tip vcrsion can also be uscd for trans septal approach, i.e., the tip of the device is pushed through the surfacc of thc heart and is used to treat the heart muscle from the inside out. In this case, the balloon is probably bet veen about 2 to 3 centirneters in ~ ter~ since turbulence becomes a problem for balloons si~nific~ntly largcr than that. In this case, since the ventricle is filled with blood, the balloon does provide vig--~li7~tion in those areas.
The balloon end contact scope and methods of the present invention will function equally well adapted to either surgical or catheter instruments, thc distinction betwcen the two being that catheter devices are generally considered to be devices used in the v;l~clll~tllre and other organ chambers of the body. A catheter tip woukl bc smallcr and adaplcd for introduction using pcrcutaneous techniques. The catheter tip version would typically have a balloon cnd of less than about l ccntimetcr diameter, and would be built on a braided or 20 larninated urcthane or othcr suitablc matcrial lumcn for push and torque.
E;IG. 4 is a cross section view of the human hcart demonstrating a preferred method of TMR from the endocardium of the present invention. In this procedure, the left ventricle 80 is internally ~cc~gged via the aorta7 ' the catheter device optionally introduced via the femoral artery or otherwise. The laser delivery 82 device P~ge 16 2 ~

extending from the outcr lumen 84 of the eatheter deviee is positioned adjaeent the endoeardiurn surfaee 86.
Micro-channels 88 are lased into the myocardium tissue 90 but do not perforate the epicardial s~rfaee 92.
Vic~li7~tion through the balloon end eontact scope portion 94 of the eatheter deviee is irnproved over eonventional catheter devices or scopcs. In this manner, the chamber filled with blood or other organ eavities 5 can be accessed, probed and treated with more preeision and eontrol than heretofore possible.
~ G. 5A is a schematic view of a preferred embodiment of a balloon end eontaet seope of the present invention. In this novel deviee, vicu:lli7~tion of the surfaee being eon~eted is greatly Pnh~nee~i A stainless steel or other material malleable shaft 200 eomprises the outer lumen of the eatheter deviee. This semi-rigid , lumen ean be introduced into the chest cavity throu6h a mini-sternotomy or trocar deviee and then positioned 10 adjacent the posterior surraee of the heart. In this manner, TMR can be perforrned on a portion of the heart otherwise visually in~cceccible. For ex~nrl~ry purposes, the surgieal or catheter deviee is shown ineluding an interventional device 202, such as a laser delivery means, and a viewing seope port 204, sueh as for a 2 millimet~ r fiber bundle. Either the entire surgical or catheter device eould be ~ d or the deviee eould also have a balloon fill port 206. The balloon 208 is attaehed to the distal end 210 ofthe deviee. Between the 15 distal end of the device and the eontact surfaee portion 212 of the balloon there is an extruded laser deliveq means guide tube 214 wi~h a central axis 215, proximal end 216 and distal end 217. Onee the balloon is plaeed against the heart surface, blood is squeezed away and a elear, Imobstrueted view of the are~ being lased ean be obtained with the viewing seope or r~ber bundle. rrovidin~ a higll friction surfaee 218 in the eentral portion of the contact surface portion will assist the surgeon rn~intain the balloon in plaee during delivery of laser energy, 20 vi~ tion, etc. A low ~ietion surfaee 219 ean be placed around the perimeter of the eont~cting surfaee portion. A sirnilar smaller scale tip ean be af~lxed to a catheter shaft or lumen and be introdueed via percutaneous catheter techniques, as shown in I;IG. 4.
~his deviee ean be eonfigured as either a eatheter deviee or as a surgical tool. A eatheter balloon end P:lge 17 will be smaller (between about ~2 and 1 cPntimeter) than that of a surgical tool (between about 1 and 3 centimeters). ~ surgical tool would have a malleable stainless steel tubing construction, or similar. A catheter device might have a braidcd-larnin?te or other high push, high torque snc~inin~ material or structure construc~ion.
I~IG. SB is a detail vicw of a balloon end contact scope of the present invention. In this embodiment, the guidc tubc 400 is dcsigncd to be somcwhat shorter in relation to the shape of the balloon. In the prior figure, the profile of the inllatcd balloon was fairly perpen-lic~ r to the central axis of the guide tube. In this embodiment, whcn a lower intcrnal pressure is used, the balloon end scope contacts the surface of the area being vi~u~li7ed at the outer pcrimeter low rriction surface 402 and the high friction surface area 404 is kept from cont:-cting the tissue surfacc. In this modality the end of the scope can slide easily over surface areas being visualized.
I~IG. SC is a dctail view of a balloon end contact scope of the present invention. In this embodiment, a higher internal balloon prcssure is utilized to fully expand the balloon. In this modality, the high friction surface area 410 will come in contact with the adjacent tissue and will assist the surgeon m~int~in the balloon in place lS during dclivery of laser energy, visualization, ete.
FIG. 6 is a graphic representation of the various components of assembly of a preferred embodiment of a balloon end contact scope of the present invention. The main body portion 220 of the balloon scope portion of IIIC cathctcr dcvicc can bc madc of a ncxible film of any suitable matcrial, including urethane, nylon, rubbcr, plastic, ctc. The contact surface portion 222 could be made of the same material or of a different material which allows for rlbcr scope vi~u;lli7 ltion througll the balloon contact wall. The contact surface portion can be sealed to the laser delivery means guide tube 224 such that the guide tube tPrmin~tPS at an opening 226 in the contact surfacc. The main body portion of thc balloon scope portion is sealed to the outer perimeter of the contact viewing portion and thc distal end of the adapter fitting 228 by any of various known or unknown, suitable P~ge 1~

sealing means, inclll(ling RF, thermal, polymeric or other.
It will be obvious to thosc skilled in the art that the above-described combination of elements comprising the balloon scopc porlion of the cathetcr dcvice of the present invention can be modified and adapted to any of various similar ~Icsi~ns. Thc main body portion, contact viewing portion and adapter fitting 5 can be integrated into a single "balloon"-type structure, or additional construction elements can be added to providc a balloon scope portion of a predetennined size, shape, orientation, Ilexibility, rigidity or transparency.
Furthermore, the balloon scope portion of thc catheter device can have mechanical, electrical, thermal, optical or acoustic sensors, tr~n~ducPrs, transceivers or other type of coupling device for detPrmining ambient temperature, electrical activity, heart ratc and pulse cycle, organ function and/or other pararneters necessary or 10 userul for perfonning TMR or other surgical procedures within thc hurnan or other animal body.
FIG. 7 is a schematic view of a preferred embodiment of the intPrf~re between a balloon end contact scope of the present invention and a lumen tip housing the distal end of a laser delivery means and a vi~ tion scope. This view clearly shows the connPction which must be made between the distal end 230 of the catheter device and the adapter fitting 232 of the balloon end contact scope of the present invention. The proximal end 234 of the laser delivery guide tube must be sealed to the distal end 236 of thc laser delivery means inner lurnen 238. The lascr fiber delivery device 240, or other interventional device, will extend through the proximal end of the lascr delivery mcans guide tube and as the balloon scope is pressed against the heart surface to bc lascd, lhc position of the l~scr dclivery mc;ms can bc visualized and controllcd precisely.
FIG. 8 is a schcmatic view of a preferred embodiment of a balloon end contact scope having p~ttPrning 20 guides built into the tip of the balloon of the prcsent invention. In this embodiment, in addition to a laser delivery mcans or other interventional device central guide tube 250, there are an additional plurality of laser delivery guide tubes 252 e~tending through the balloon and attachcd to the balloon cont~cting surface 254 at certain, predctPrrnined positions 256. The precise positions can be selected as desired, the group of three fibers P~e 19 2 ~

or other waveguides shown in the figure being representativc of a preferred embodiment. Furthermore, it will be understood that in addition to or instead of laser delivery means, othcr rnicro-surgical instmrnents may be useful or required for certain procedures, including irrigation, visualization, dye swabbing, marking or scannin6, or other general or specirlc access to an intemal organ. The balloon access ports 258 will also be used.
FIG. 9 is a schematic view of a prcferred embodiment of a suction cup-type fluoroscope locator and guide tether of the prcsent invcntion. This device serves multiple uses, including usc as a fluoroscopic marker or locator as well as a guide tether for a monorail-type mounted catheter device which can be positioned prccisely thercby. This is important bccause spatial refercnccs arc casily lost whcn working through long ports, using cameras and tools with bends. Marking might help the surgeon developing a certain expertisc perforrning TMR or other procedures. Extending through a malleable lumen 260 which forrns the outer lumen of the device, a thin floppy vacuum line and tether 262 is attached at its distal end 264 to a soft rubber suction cup 266. It will be understood that the m~lt~ri~l~ of construction for the various components may be rigid, semi-rigid or flexible m~tPri~l~, as might be indic:lted In the preferred embodiment the suction cup or a portion thereof might be filled with a radio-opaque material, such as 20% barium or bismuth solution, or other m~lt~-ri~l~ In this manner, the position of the suction cup can be det~rmined precisely using known meth~ds of fluoroscopy. At thc proximal end 268 of the malleable lumen, or somc othcr position, a spring-loaded pin 270 cxtends into a channcl 272 in thc mcch:lnicm housing 274,thercby pinchin6 thc tube in certain configurations.
A source of vacuum 276 would be used.
I~IG. 10 is a schematic view of a preferred embodiment of the device and method of performing TMR
or other proccdure. The system includes a suction cup-type ~luoroscope locator and guide-tubing tether 280 anchored to tissue 282 adjacent thc area being viewcd or lased. A dye swab 286 could be advanced through access port 290. The access port is rotatably opened or closed co2l~lncting o-ring 292 to provide a vacuum tight P~ge20 but slidable seal on the advancing dye swab. A vacuurn source 294 would also be used. This ernbodirnent converts fluoroscopic location of the suction cup to a visual heart surface identifier for subsequent use of product as shown in l;IG. 5A.
I;IG. 11 is a schcmatic view of a prcferred embodiment of a suction cup-type fluoroscope locator and S g~ude tether 300 in conjunction with a surgical device 302 of the prcsent invention. The device has a plurality of laser delivery mcans 304 extending therefrom. The device has a slider 306 which rides on the tether up to the point where thc suction cup 308 or attachment clip is attached to the tissue adjacent the area to be lased.
Rotation of the devicc in a direction B about the point of attachmcnt by the suction cup portion onto the tissue will be f~cilit~terl FIG. 12 is a graphical representation of the beam pattem and ch~nnelc creatcd by a catheter device with a plurality of laser delivery means extending therefrom. As will be apparent to those skilled in the art, it is possible to anchor the devicc to the subject tissue at a tether anchor point ~, for example, and then lase the tissue with all of the extending laser delivery means cim~ neQusly. Once a first set (denoted by the dashed lines 322) of channels 324 are created, slight re-orientation of the dcvice about the attachrnent point will 15 position the extending laser delivery means to create a new set of channels in a position precisely defined in spatial relation to the tether anchor point. A series of channel sets c;m be created completely around the tether anchor point and revasculari_ation at any indicated channel densily in a given, precisely d~tfrrnined position c~n be acllieved.
FIG. 13 is a srhem~ic view of a prefcrred embodirnent of a lateral aspect positioning device applicator 20 of the present invention for use with nuO~uScOpc locators and guidc tethers. In this view, it is shown how parts of the heart 320 or any other org;m or body part being worked on or near or behind are oReh situated in such a way as to make direct vi~u~li7~tion impossible. In modern, less-invasive surgical techniques it is impossible to manipulate the organ in the same way as if perfomling the procedure via an open chest cavity. In this view, a P~e 21 clip or other tether locator device applier 322 inserted, optionally through a trocar device 324. The applier has a bend at one cnd, with a given radius R and angle of oricntation Y. Though there might be a plurality or bends or curves in thc tcther applier dcvicc, as appropriate for the ~.occlu-~ being performcd, a standard radius of curvature might bc bctwcen about I and S inches and the angle of orientation between about 45 and 120 5 degrees. The device can rcach around to the b~ck of the heart or other organ or orifice to attach a tether clip or suction cup or perform a marking or othcr function.
FIG. 14 is a schematic view of lhe mcthod of operation of a preferred embodimcnt of a f uoroscope loc~tor and guide tether in conjunction with a monorail-type mount catheter device of the present invention.
Once in place, in this vicw attachcd to a tether anchor point 330 in the back of the hcart, the guide tether 332 leads back through the trocar device 334, if used. Along the tether a catheter device 336 with a slider 338 can be slid along the tether through the trocar device or other entry point to the chest cavity or v~sc~ -re, and positioned adjaccnt the guide tether anchor point.
I;IG. 15 is a schematic view of a preferred embodirnent of a guide tether clip of the present invention having surface coining. In addition to the suction cup-~ypc nuoroscopic markcr and tcthcr anchor, the guide can also bc anchored to thc heart other tissuc, bonc or other structure with a removable clip 350. Made out of metal, plastic, special radio-opaque or other suitable m~t~ri:ll Coining marks 352 are often useful to enhance the gripping quality of thc clip. These marks could be made in the molding or forming process, or stamped in or otherwise applied after fabrication.
~IG. 16 is a schematic vicw of a preferrcd embodiment of a guide tether and clip of the present invention. In this view, the distal end 360 of lhe tether 362 is sho-vn attached to lhe removable clip 364. It will be understood by those skilled in the art that the m:ltPn~lc of co-,sll.l.;tion, ~imt~nsionC and methods of using these systems may be modified to suit the particular patient's needs, the surgeon's expertise and preferred procedure, etc.

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~25 . .

Claims (15)

1. A device for performing laser-assisted myocardial revascularization (TMR) in a minimally invasive surgical procedure and configured to reach and view accessible and generally inaccessible surfaces of a heart or organ chamber, the device comprising:
an outer lumen having proximal and distal ends, the outer lumen adapted for conveying at least a laser delivery device;
a scope portion at the distal end of the device and defining an at least partially essentially transparent, contact viewing portion and a body portion, the body portion disposed between the contact viewing portion and the distal end of the outer lumen;
at least one aperture through the at least partially essentially transparent, contact viewing portion, the at least one aperture adapted for receiving a laser delivery device; and a viewing device operatively associated with the at least partially essentially transparent, contact viewing portion.

2. The device of Claim 1 further comprising a laser delivery device for performing myocardial revascularization, the scope portion configured to fit through a conventionally minimally invasive port placed between adjacent ribs of a rib cage.

3. The device of Claim 2 wherein the scope portion is collapsible to be adapted for insertion through the port and expandable when placed as desired.

4. The device of Claim 3 wherein the outer lumen is adapted for attachment of an inflation apparatus for introducing a fluid into the scope portion which is an expandable balloon.

5 The device of Claim 1 further comprising a hollow guide extending between the aperture and the distal end of the outer lumen and adapted for insertion of the laser delivery device therethrough.

6. The device of Claim 1 wherein the scope portion is expandable and the contact viewing portion stabilizes the device on the heart, the contact viewing portion further comprising a high friction surface area and a low friction surface area, a relatively low internal pressure in the expandable scope portion causing the low friction surface area to contact tissue and a relatively high internal pressure causing both the relatively high and relatively low friction surface areas to contact tissue.

7. The device of Claim 5 having a plurality of laser delivery devices extending through the outer lumen and through a plurality of hollow guides and extendable through a plurality of apertures through the at least partially essentially transparent contact viewing portion.

8. The device of Claim 7 wherein the outer lumen defines a plurality of inner lumens for extension of the plurality of laser delivery devices to the plurality of hollow guides aligned with the plurality of inner lumens.

9. The device of Claim 1 wherein the viewing device is a fiber optic assembly for visualization.

10. The device of Claim 1 wherein the viewing device is a visualization scope in the scope portion and in visual contact with the essentially transparent contact viewing portion.

11. The device of Claim 1 wherein the outer lumen is at least partially rigid.

12. The device of Claim 1 wherein the outer lumen is flexible.

13. The device of Claim 1 further comprising a tether for removably attaching the outer lumen thereto, the tether defining a means for securing the tether to tissue.

14. The device of Claim 13 wherein the means for securing the tether to tissue is a suction cup.

15. The device of Claim 13 wherein the means for securing the tether to tissue is a 21. Use of the device of claim 1, 2, 3, 4, S, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 for performing laser-assisted myocardial revascularization.

22. Use of the device of claim 17, 18, 19 or 20 for performing myocardial revascularization.