US20030125630A1

Movatterモバイル変換

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Publication number: US20030125630A1
Application number: US10/037,306
Authority: US
Inventors: Simon Furnish
Original assignee: Infraredx Inc
Current assignee: Infraredx Inc
Priority date: 2001-12-31
Filing date: 2001-12-31
Publication date: 2003-07-03
Also published as: US8386023B2; US20110230770A1

Abstract

A catheter tip apparatus arranged in a catheter for the delivery and collection of a light-energy signal to permit subsequent computerized analysis of body tissue by the collected signal. The apparatus comprises an elongated housing supporting a first reflective surface and a second reflective surface. The first reflective surface and the second reflective surface are longitudinally spaced apart from one another. A first flexible, elongated energy bearing delivery fiber has a distalmost end arranged adjacent the first reflective surface. A second flexible, elongated energy bearing collection fiber has a distalmost end arranged adjacent the second reflective surface. The housing is rotatably supported on a flexible catheter sheath for insertion of the catheter into a mammalian body for tissue analysis thereof.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention[0001]

This application relates to photo-medical devices, and more particularly to photo-medical devices that deliver and collect radiant energy to permit body tissue analysis and/or treatment, and is co-pending with commonly assigned patent application Ser. No. ______, entitled “Multi-Fiber Catheter Probe Arrangement for Tissue Analysis or Treatment” (InFraReDx-14) which is incorporated herein by reference in its entirety.[0002]

2. Prior Art[0003]

The sensing and treating of various tissue characteristics in the in vivo intravascular environment is desirous for many reasons yet difficult because it is a very harsh environment in which to conduct such analysis or treatment. The presence of blood and its constituents such as cholesterol may effect scattering and absorption of energy signals transmitted within an organ. Diagnosis and treatment of various tissues within the human body using an in vivo probe necessitates adaptive characteristics for that probe when it is inserted into a mammalian body organ.[0004]

It is an object of the present invention to provide a probe for insertion within a mammalian body which overcomes the disadvantages of the prior art.[0005]

It is a further object of the present invention to provide a minimally invasive device for light energy transmitting (i.e. infrared through ultraviolet) diagnosis and treatment of mammalian tissue through the use of endoscopes, catheters and other minimally invasive devices. It is still yet a further object of the present invention to provide optical probe tip arrangement which facilitates optimum delivery and retrieval of energy signals within the human body tissue.[0006]

BRIEF SUMMARY OF THE INVENTION

The present invention provides several preferred embodiments of apparatus and of method of use of that apparatus to analyze body tissue using an energy spectrum analysis distributed and received by an elongated probe introducable through a catheter into that body tissue. That introduction of the body probe may be done through an endoscope, or other catheter-like devices for such energy diagnosis and treatment of tissue. That energy analysis and treatment may include near infrared (NIR) reflectance spectroscopy, Raman spectroscopy, fluorescence spectroscopy, photodynamic drug activation, photonic ablation or thermal treatments, and optical coherence tomography.[0007]

The probe of the present invention comprises an elongated, generally cylindrically shaped housing having a first or distal end and a second, or proximal end. The proximal end has a stem thereon of reduced diameter from the diameter of the distalmost portion thereof. An elongated groove is arranged to extend from the proximal end of the stem through towards the distal end of the housing. The groove is disposed through only one side of the housing, and has an arrangement of angled shoulders therein for providing snug receipt of the collector and the delivery fiber arrangement.[0008]

The collector fiber arrangement in this particular embodiment includes an elongated flexible collection fiber having a distal end to which a reflector or reflective surface (i.e., a mirror member) is attached. The collection fiber has an outer buffer such as a sheath for protection of the fiber and to minimize stray radiation therefrom. A mirror member has an angularly disposed reflective surface thereon. The delivery reflector (or mirror member) is attached to an optical delivery fiber which is enclosed similarly by an outer buffer such as a sheath for protection of the fiber and for minimization of light leakage. The delivery reflector or mirror member has an angled reflective surface thereon. The collection fiber and reflector and the delivery fiber and reflector jointly mate within the elongated receiving groove within the stem and tip housing. The elongated groove is preferably shaped to effect accurate positioning of the respective reflectors or mirror members therein, so as to emit radiation from the delivery reflector (or mirror member) and receive radiation reflected back from a body tissue sample in the collection reflector (or mirror member). Once the collection and delivery fibers are within the housing, those joint fibers may be inserted within an elongated catheter shaft or rotatable coil as will be described hereinbelow.[0009]

A further embodiment of the present invention is disclosed by a elongated support frame having a proximal end and a distal end. The proximal end includes and upstanding portion through which a collection fiber channel is arranged (i.e., molded, drilled, machined). A rectilinearly-shaped holding pocket is arranged distal of the first upstanding member and is arranged to receive a reflective mirrored surface for example, a collection prism, thereon. A midblock portion is arranged centrally in the support frame and has a delivery fiber channel arranged therewithin, the delivery fiber channel extending parallel and adjacent the collection fiber channel. A second holding pocket is similarly arranged adjacent the delivery fiber channel for receipt of a second reflector such as a reflective mirrored surface, such as for example, a mirror member, having a mirrored surface thereon. The holding pockets are constructed so as to accurately receive and align the respective first and second mirror members to the desired angle for the desired photon delivery and photon collection from a target body tissue. The elongated support frame is arranged within an elongated housing, having an elongated channel for receipt thereof. A delivery fiber and a collection fiber would be inserted within their respective channels and the respective reflectors (i.e. mirror members) would be secured (i.e. affixed by adhesive) within their respective holding pockets.[0010]

A further embodiment of the optical probe arrangement of the present invention is characterized by a generally cylindrically shaped frame member having a stepped down stem portion on its proximal end thereof. The frame member is arranged so as to define a series of distal step portions, the first portion of which is arranged to receive a collection reflector (i.e. mirror member or reflective surface) and second stepped portion receives a delivery reflector (i.e. mirror member or reflective surface). A bore or channel is arranged through the frame member for servicing each particular reflector. Each respective channel receives an optical fiber which is arranged to abut one surface of its respective reflector. The distal cover may be arranged so as to mate over the respective collection reflector and the delivery reflector while having a slot for passage of a photonic signal therethrough. The delivery reflector is thus permitted to emit photonic radiation and the collection reflector is permitted to receive photonic radiation when the frame member is assembled with the cover, and the stem is attached in holding the particular fiber, and those fibers are inserted within a hollow torqueable transmission shaft such as a counterwound, multifilar drive shaft coil arrangement proximal of that frame member.[0011]

A further embodiment of the probe arrangement is shown by an elongated frame member having a proximal end and a distal end. The proximal end of that frame member is arranged so as to define an angled reflective surface thereat, the distal end of that frame member having a second reflective surface angularly disposed thereon with an oval end cap thereon. A bore is arranged through the proximal end of the elongated frame member to define a receiving channel for a delivery fiber to be inserted therewithin. The entire elongated frame member is inserted into an elongated cylindrically shaped housing having a proximal end and a distal end. The proximal end of the housing has a stem of stepped down diameter, which stem encloses an energy delivery fiber and an energy collection fiber. The stem of the housing is arranged to receive the collection fiber which is arranged to receive reflective signals from its reflector surface arranged onto the elongated frame member. The housing has an opening arranged longitudinally therein, so as to receive the elongated frame member. The housing also has a slot cut through a side portion thereof so as to permit the energy signal to be delivered and received by the respective reflective surfaces contained therewithin. The end cap on the distalmost end of the elongated frame member abuts the distalmost end of the elongated housing to define a smooth continuous surface therearound.[0012]

A further embodiment of the present invention resides in a one piece housing of generally cylindrical shape having a proximal portion of stepped down diameter defining a stem. A first reflective collection surface is disposed at a particularly desired angle adjacent the stem of the elongated housing, and a second reflective surface is arranged into the elongated housing adjacent its distalmost end. A first bore is arranged through the housing through the stem so as to receive a collection fiber. A second bore is also arranged through the elongated housing so as to support a delivery fiber therethrough. The stem may be received in a pair of hollow, flexible, counterwound coils which function as a torqable transmission shaft which is secured to the stem and surrounds the delivery and collection fibers received therethrough. The first and second reflective surfaces arranged in the housing, in this embodiment, may be skewed (non-parallel or curvilinear) so as to emit and receive signals from any particular direction with respect to its adjacent reflective surface.[0013]

A yet further embodiment of the present invention relates to a method of constructing a catheter tip arrangement for support of a plurality of optical fibers, which support construction permits minimization of component size and adaptive angularity of reflection of the delivery and collection beams. Such a support may be accomplished by micromachining construction where additive processing such as for example: plating, sputtering, vapor deposition, and subtractive processing such as for example: etching, laser cutting and ablation, permits finite adjustment to the dimensions. The support comprises a base upon which an arrangement of parallel bosses are “grown”, the bosses defining between them, a pair of parallel slots into which a delivery and a collection fiber may be mated. A mirror surface and support struts are spaced at the distalmost location of the fibers, which mirror surface may be curved or manipulably bent to the desired angle for maximizing optical analysis and tissue treatment thereby. This embodiment contemplates the use of index-matching fluids added to any gap between a catheter sheath surrounding the fibers to reduce any back reflections from the interior of the protective sheath/transmission window.[0014]

The invention may also comprise a catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, the apparatus comprising an elongated housing having a longitudinal axis of rotation, the housing having a first reflective surface disposed thereon, a second reflective surface disposed on the housing distally of the first reflective surface and in axial alignment therewith. A first light conductive fiber may be in light-coupled communication with the first reflective surface and a second light conductive fiber in light-coupled communication with the second reflective surface, the first light conductive fiber in communication being in communication with a controlled analytical-light generating source and the second light conductive fiber being in communication with a light-collection analysis device. A curvilinear cover may be arranged to mate over a distal portion of the housing to enclose the reflective surfaces, the cover having at least one opening on an annular surface thereof to permit light delivery to the body tissue, and to permit light collection therethrough upon reflection from the body tissue. At least one of the reflective surfaces may comprise a mirror or polished surface. Each of the light conductive fibers has a distal end arranged within said housing, and the at least one of the light conductive fibers is in abutting relationship with a non-reflective surface of the member containing the reflective surface. At least one of the reflective surfaces may be disposed in a holding pocket. The reflective surface may be secured in the holding pocket by an adhesive.[0017]

The invention also comprises a catheter tip apparatus having a first reflective surface and said second reflective surface which are disposed at an angle proportional to the numerical aperture of the first and second foptical ibers, to yield a light beam with adjacent edges that are parallel to one another, to permit a distance independent delivery reflector-collector reflector separation.[0018]

The invention may also comprise a catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, comprising an optically transparent sheath enclosed elongated housing having a longitudinal axis of rotation, the housing having a first reflective surface disposed thereon, a second reflective surface disposed on the housing distally of the first reflective surface and in axial alignment therewith, a first light conductive fiber in light coupled communication with the first reflective surface and a second light conductive fiber in light coupled communication with the second reflective surface, the first light conductive fiber in communication being in communication with a controlled analytical-light generating source and the second light conductive fiber being in communication with a light-collection analysis device. A generally curvilinear cover may be arranged to mate over a distal portion of the housing to enclose the reflective surfaces, the cover having at least one opening on an annular surface thereof to permit light delivery to the body tissue, and to permit light collection therethrough upon reflection from the body tissue. At least one of the reflective surfaces may comprise a mirrored member. Each of said light conductive fibers may have a distal end arranged within the housing, and the at least one of the light conductive fibers is in abutting relationship with a non-reflective surface of the mirrored member. At least one of the reflective surfaces may be disposed in a holding pocket. The reflective surface may be secured in the holding pocket by an adhesive. An index matching fluid may be disposed about the reflective surfaces to minimize back reflections thereto, from the outer sheath.[0019]

The invention may also comprise a catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, comprising an optically transparent sheath enclosed elongated housing having a longitudinal axis of rotation. The housing may have a first reflective light delivery surface disposed thereon and a first reflective light collection surface disposed on the housing distally of the first reflective light delivery surface and in axial alignment therewith. A first light conductive fiber is in light coupled communication with the first reflective light delivery surface and a second light conductive fiber is in light coupled communication with the first reflective light collection surface, the first light conductive fiber in being in communication with a controlled analytical-light generating source and the second light conductive fiber being in communication with a light-collection analysis device, and a second reflective light collection surface may be disposed on the housing distally of the first reflective light collection, the second reflective collection surface may also be in communication with the controlled analytical-light generating source and in axial alignment therewith. The first and second reflective surfaces are thus arranged to permit deep tissue light energy penetration and collection and analysis thereby. Reflectors may otherwise be known as beam redirecting members comprised of aspheric members, planar, spherical, convex surfaces, concave surfaces, comprised of mirrors, dielectric mirrors, refractive index interfaces or diffractive optical elements.[0020]

The invention may also include a method of delivering and collecting a tissue-striking light energy signal from a first light fiber and adjacent delivery reflector and returning said light energy signal to a collection reflector adjacent a second light fiber for analysis and tissue treatment. The method includes spacing the collection reflector distally of the delivery reflector in a sheath enclosed elongated catheter housing tip, the housing having a longitudinal axis; disposing the reflectors at an angle with respect to the longitudinal axis of the elongated housing proportional to a numerical aperture of the first and second energy fibers. The method may include bathing the reflectors in an index matching fluid to minimize back reflection in the sheath enclosed housing, and directing the delivery light energy signal and the collection light energy signal so as to yield adjacent edges thereof that are parallel.[0021]

Thus what has been shown as a unique arrangement of structures for supporting energy carrying fibers such as flexible optical fibers to permit particular radiation to be delivered from one reflective surface and collected on a second adjacent reflective surface and analyzed in a computer apparatus at the proximal end of those fibers.[0022]

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and advantages of the present invention will become more apparent when viewed in conjunction with the following drawings in which:[0023]

FIG. 1 is an exploded view of a probe housing and an optical fiber arrangement adaptable for insertion into a mammalian body;[0024]

FIG. 2 is a view similar to FIG. 1, showing the fiber components arranged within the elongated housing;[0025]

FIG. 3 is an exploded view in perspective, of a prism and support frame arrangement and a housing for that support frame, for attachment on the distal end of a set of optical fibers;[0026]

FIG. 4[0027]ais a view of a collection and delivery probe arranged on the distal end of a transmission coil in a perspective view thereof;

FIG. 4[0028]bis an exploded view of the coil and probe components shown in FIG. 4a;

FIG. 5[0029]ais a perspective view of an assembly of an elongated housing having a pair of reflective surfaces arranged therewithin;

FIG. 5[0030]bis a view similar to FIG. 5ashowing the frame components thereof without the surrounding elongated housing;

FIG. 6[0031]ais a perspective view of a probe assembly showing a one piece housing arrangement with optical fibers in a counterwound coil;

FIGS. 6[0032]b,6cand6dare side elevational views of the housing shown in FIG. 6a;

FIG. 7 shows a perspective view of a fiber supporting catheter tip housing arrangement manufactured by additive and subtractive methods;[0033]

FIG. 8 shows a schematic representation of multiple collection fibers in a housing; and[0034]

FIGS. 9[0035]aand9bshow reflectors arranged in their elongated housing for parallel light reflective beams.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in detail, and particularly to FIG. 1, there is shown a first embodiment of the present invention which comprises a[0036]

catheter tip apparatus

10 and a method of use of thatapparatus10 to provide an analysis of body tissue using an energy spectrum analysis distributed and received by anelongated probe12 introducable through acatheter sheath14 into that body tissue. That introduction of thecatheter sheath14 andbody probe12 may be done through an endoscope, or other catheter-like devices, not shown, for such energy diagnosis and treatment of tissue by a proper computer apparatus15. The energy analysis and treatment might include fluorescence spectroscopy, near infrared (NIR) reflectance spectroscopy, Raman spectroscopy, and optical coherence tomography, photodynamic drug activation, photonic ablation and thermal treatments.

The[0037]

probe

12 of the present invention comprises an elongated, generally cylindrically shapedhousing16, as shown in FIGS. 1 and 2, having a first ordistal end18 and a second orproximal end20. Theproximal end20 has astem22 thereon of reduced diameter from the diameter of thedistalmost18 portion thereof. Anenlongated groove24 is arranged to extend from theproximal end20 of thestem22 through towards thedistal end18 of thehousing16, as may be seen in FIGS. 1 and 2. Thegroove24 extends only through one side of the housing, and has an arrangement of

angled shoulders

26 and28 therein for providing snug receipt of thecollector fiber30 and the delivery fiber32.

The collector fiber arrangement in this particular embodiment includes the elongated[0038]

flexible collection fiber

30 having a distal end34 to which a reflector or reflective surface36 (i.e. mirrored/polished member) is attached. Thecollection fiber30 has an outer buffer38, for protection of the fiber and to minimize stray radiation therefrom. Thereflector36 has an angularly disposedreflective surface40 thereon.

The[0039]

delivery reflector

42 is attached to an optical delivery fiber44 which is enclosed similarly by an outer buffer46 such as a sheath for protection of the fiber and for minimization of light leakage. Thedelivery reflector42 has an angled reflective surface48 thereon. Thecollection fiber30 and attachedreflector36 and the delivery fiber44 and its attachedreflector42 jointly mate within the elongated receivinggroove24 within the stem and tiphousing16. Theelongated groove24 is preferably shaped to effect accurate positioning of the

respective reflectors

36 and42 therein, so as to emit radiation from thedelivery reflector42 and receive radiation reflected back from a body tissue sample through the collection (reflector)36. Once the collection anddelivery fibers30 and44 are within thehousing16, thosejoint fibers30 and44 may be inserted within theelongated catheter shaft14 or rotatable coil as will be described hereinbelow. A further embodiment of the present invention shown in FIG. 3 and is disclosed as anelongated support frame50 having aproximal end52 and adistal end54. Theproximal end52 includes an upstanding portion56 through which a collection fiber support and alignment channel58 is arranged (i.e. molded, drilled, machined). A rectilinearly-shaped holding pocket60 is arranged distal of the first upstanding member56 and is arranged to receive a reflective mirrored surface62, (for example, a reflective collection member) having a reflectingsurface64 thereon. An upstanding midblock potion66 is arranged centrally of thesupport frame50 and has a delivery fiber support andalignment channel68 arranged therewithin. Thedelivery fiber channel68 extends parallel and adjacent the collection fiber channel58. A second holding or receivingpocket70 is similarly arranged distally adjacent the midblock portion66 for adhesive receipt of a second reflector or mirrored surface (i.e. mirror or reflective member)72 having a mirroredsurface74 thereon. The holding pockets60 and70 are constructed so as to accurately receive and align the respective first and second reflector arrangements (i.e. mirrors or reflective members)62 and72 to the desired angle for the desired photon delivery and photon collection from a target body tissue, not shown for clarity. Theelongated support frame50 is arranged within an elongated generally U-shaped housing76, having anelongated channel78 for receipt thereof. A delivery fiber and a collection fiber would be inserted within theirrespective channels68 and58 and the respective reflectors (i.e. reflective members/mirrors)72 and62 would be secured (i.e. affixed by adhesive) within those respective holding pockets70 and60.

A further embodiment of the optical probe arrangement of the present invention is shown in FIGS.[0040]4(a) and4(b) and is characterized by a generally cylindrically shapedframe member80 having a stepped downstem portion82 on its proximal end thereof, as may be seen in FIG. 4(b). Theframe member80 is arranged so as to define a series of

distal step portions

84 and86, thefirst portion84 of which is arranged to receive a collection reflector (i.e. reflective member or reflective surface)88 and the second steppedportion86 receives a delivery reflector (i.e. reflective member or reflective surface)90. A bore or

channel

92 and94 is arranged through theframe80 for servicing eachparticular reflector88 and90. Each

respective channel

92 and94 receives acollection fiber96 or anoptical fiber98 which is arranged to abut aplanar surface100 and102 of itsrespective reflector88 and90. Adistal cover104 as shown in FIG. 4(a) may be arranged so as to mate over the respective collection reflector88 anddelivery reflector90 while having aslot106 for passage of a delivered or received photonic signal therethrough. Thedelivery reflector90 is thus permitted to emit photonic radiation and the collection prism88 is permitted to receive photonic radiation when theframe80 is assembled with thecover104 and thestem82 is attached and holding the

particular fibers

96 and98, and those

fibers

96 and98 are inserted within a hollow, torqueable transmission shaft such as a counter wound multifilar driveshaft coil arrangement108 proximal of thatframe member80 and secured to thestem82.

A further embodiment of the probe arrangement of the present invention is shown in FIGS.[0041]5(a) and5(b) by anelongated frame member116 having aproximal end118 and a distal end120, as may be best seen in FIG. 5(b). Theproximal end118 of thatframe member116 is arranged so as to define an first angledreflective surface122 at anupright portion124 thereof, the distal end120 of thatframe member116 having a secondupright portion125 with a secondreflective surface126 angularly disposed thereon with anoval end cap128 thereon. Abore130 is arranged through theupright portion124 on theproximal end118 of theelongated frame member116 so as to define a receiving channel for adelivery fiber132 to be inserted therewithin. The entireelongated frame116 is inserted into an elongated housing134, as shown in FIG. 5(a), having aproximal end136 and adistal end138. Theproximal end136 of the housing134 has a stem140 with a stepped down diameter which encloses thedelivery fiber132 and acollection fiber142. The stem140 of the housing134 is arranged to receive thecollection fiber142 which is arranged to receive reflective signals from itsreflection surface122 arranged onto theupstanding portion124 of theelongated frame member116. The housing134 has an opening144 arranged longitudinally therein, as shown in FIG. 5(a), so as to receive theelongated frame member116. The housing134 also has a slot146 cut through its side portion thereof so as to permit the photonic energy signal to be delivered and received by the respective

reflective surfaces

126 and122 contained therewithin. Theend cap128 on the distalmost end120 of theelongated frame member116 abuts thedistalmost end138 of the elongated housing134 to define a smooth continuous surface therearound.

A further embodiment of the present invention resides in a one[0042]

piece housing

150 of generally cylindrical shape, (as may be seen in FIGS.6(a),6(b),6(c) and6(d)), having aproximal portion152 of stepped down diameer defining a reduced-diameter fiber-enclosingstem154. A firstreflective collection surface156 is disposed at a particularly desired angle near thestem154 of thehousing150, and a secondreflective surface158 is disposed onto theelongated housing150 adjacent itsdistalmost end160. A first channel or bore162 is arranged through theproximal end152 of thehousing150 adjacent thestem154 so as to snugly and alignably receive asignal collection fiber164. A second channel or bore166 is also arranged through the proximal half of theelongated housing150 so as to alignably support a delivery fiber168 therethrough. Thestem154 may be received in a pair of hollow, flexible, counterwound coils170, as shown in FIG. 6(a), which coils170 that function as a torqueable transmission shaft, is secured to thestem154 and surrounds the delivery andcollection fibers168 and164 received therethrough. The first and second

reflective surfaces

156 and158 arranged into thehousing150, in this embodiment, and which is depicted by light energy waves E1 and E2 reflecting with respect thereto, may be skewed (non parallel or curvilinear) with respect to one another so as to emit and receive signals from any particular direction with respect to the surface of an adjacent reflective tissue “T”. FIG. 6(c) represents thehousing150 with the respective

reflective surfaces

156 and158 being spaced further longitudinally apart than is depicted in FIG. 6(b). This permits different scattering patterns E1 and E2 to be delivered and hence received by thecatheter tip apparatus10. FIG. 6(d) represents the manufactured

reflective surfaces

156 and158 at a skewed angle with respect to one another to present further signal delivery and collection characteristics with respect thereto. The fiber bores154 and162 are oppositely aligned and diametrically disposed across the longitudinal axis of rotation “R” of thehousing150. This minimizes eccentric rotation of thehousing150, the fibers borne therein and signal distortion during rotation of thehousing150 in a body vessel during analysis of tissue “T”.

A yet further embodiment of the present invention is shown in FIG. 7, wherein a[0043]

platform

180 relates to a method of constructing acatheter tip arrangement10 for support of a plurality of two or more optical delivery and

collection fibers

182 and184, which “support” construction permits minimization of component size and adaptive angularity of reflection of the delivery and collection beams B1 and B2. Such asupport platform180 may be accomplished by micro-machining construction where additive or subtractive processing such as for example: etching, plating, sputtering, vapor deposition and subtractive processing such as etching, laser cutting and ablation permits finite adjustment to the dimensions. Thesupport platform180 comprises a base186 upon which an arrangement of elongated,

parallel bosses

188,190 and192 are “grown”, the

bosses

188,190 and192 defining between them, a pair of parallel slots194 and196 into which a delivery and a

collection fiber

182 and184 may be respectively mated. Amirror surface198 and200 and support struts200 and202 are spaced at the distalmost location of the

fibers

182 and184, which mirror surfaces198 and200 may be curved or manipulably bent to the desired angle for maximizing optical analysis and tissue treatment thereby. This embodiment shown in FIG. 7 contemplates the use of index-matching fluids206 added to any gap between acatheter sheath204 surrounding the

fibers

182 and184, to reduce any back reflections from the interior of the protective sheath/transmission window.

FIG. 8 shows a schematic representation of a catheter tip disposed[0044]

elongated housing

210 having an opticalenergy delivery fiber212 and a first opticalenergy collection fiber214 and a second opticalenergy collection fiber216 in optical communication with a mammalian tissue “T8”. Each

fiber

212,214 and216 have a

reflective surface

218,220 and222 disposed distally thereof respectively, as shown in FIG. 8. The

reflective surfaces

218,220 and222 are axially spaced apart from one another.

Multiple collection fibers

214 and216 with axially spaced apart collection

reflective surfaces

220 and222 permit collection and analysis of light that has penetrated more deeply into the tissue “T8”. The

reflective surfaces

218,220 and222 may be aspheric volumes, or flat, convex, concave or curved members having an arcuate surface to present a straight reflective beam, a spread-out beam, a focused beam which may overlap one another, be parallel to one another, or in alignment with one another.

Multiple collectors

220 and222 permits the receiving or collection of light emitted from a single source but collected from more than one collector arranged at spaced apart locations within the tissue being investigated. The beams may have a delivery numerical aperture NA of between NA=0.1 and NA=0.6 and a collection numerical aperture NA of between NA=0.1 and NA=0.7. Bean redirecting members such as mirrors preferably have separations of about 0.1 mm and 2 mm.

A more preferential delivery and collection beam geometry is shown in FIGS. 9[0045]aand9bhaving a catheter tip disposedelongated housing230 having anoptical delivery fiber232 and an opticalenergy collection fiber234 in optical communication with mammalian tissue “9a”. A reflective surface236 delivers a generally radially delivered light beam L9 and areflective surface238 collects the generally radially directed returning light beam L9. Adjacent portions of the delivered beam and the returning beam in this embodiment are parallel, because the delivery andcollection reflectors236 and238 are disposed at chosen angles proportional to the numerical aperture of the delivery and

collection fibers

232 and234 to yield energy beam having edges that are parallel to permit distance independent delivery-collector separation, such angularity of the reflectors236′ and238′ being shown at a less steep angle with respect to the longitudinal axis A9, in anelongated housing230′, represented in FIG. 9b. It is also contemplated that each fiber may be utilized for both delivery and collection of light energy.

Thus what has been shown as a unique arrangement of structures for supporting energy carrying fibers or waveguide elements to permit particular radiation to be delivered from at least one beam redirecting member such as a reflective surface and collected on the same or at least a second adjacent beam redirecting member such as a second reflective surface and analyzed in a light signal analyzer computer apparatus connected to the proximal end of those fibers, waveguides or beam bearing members.[0046]

Claims

I claim:

1. A catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent light energy beam analysis of body tissue by the collected signal, comprising:

an elongated housing supporting a first reflective surface and a second reflective surface, said first reflective surface and said second reflective surface being longitudinally spaced apart from one another;

a first flexible, elongated energy bearing delivery fiber having a distalmost end arranged adjacent said first reflective surface;

a second flexible, elongated energy bearing collection fiber having a distalmost end arranged adjacent said second reflective surface; and

said housing rotatably supported on a flexible catheter sheath for insertion of said catheter into a mammalian body for tissue analysis thereof.

2. The catheter tip apparatus as recited inclaim 1, wherein said housing comprises a frame member having a slot arranged therein for receipt and alignment of said first and said second reflective surfaces.

3. The catheter tip apparatus as recited inclaim 1, wherein said first reflective surface and said second reflective surface each comprise a beam redirecting member.

4. The catheter tip apparatus as recited inclaim 2, wherein said slot has shoulders therein to guideably secure and accurately align said reflective surfaces therein.

5. The catheter tip apparatus as recited inclaim 2, wherein said housing has a proximalmost stem portion for receipt into a catheter sheath to permit manipulation of said tip from a proximal location.

6. The catheter tip apparatus as recited inclaim 1, wherein said housing comprises a frame member having a proximal end and a distal end, with an upstanding proximal block and an upstanding midblock, each block having a pocket thereadjacent for receipt of a reflective surface attachable therein.

7. The catheter tip apparatus as recited inclaim 6, wherein said reflective surface comprises a mirror glued into said pocket.

8. The catheter tip apparatus as recited inclaim 6, wherein each of said upstanding blocks has a bore therethrough for receipt of one of said energy bearing fibers.

9. The catheter tip apparatus as recited inclaim 1, wherein said housing comprises an elongated generally cylindrically shaped frame member with a proximal end and a distal end, said frame member having at least two steps thereon of decreasing thickness in the distal direction, each of said steps having a reflective surface mounted thereon, said proximal end having a stem portion of reduced diameter, to permit rotative receipt within a catheter sheath.

10. The catheter tip apparatus as recited inclaim 9, wherein said frame member has a cover member arranged to mate over said steps and said reflective surfaces.

11. The catheter tip apparatus as recited inclaim 10, wherein said cover member has an axially arranged slot thereon through part of its longitudinal length, said slot being disposed radially adjacent each of said reflective surfaces to permit delivery and reflected collection of an energy beam therethrough.

12. The catheter tip apparatus as recited inclaim 9, wherein said stem portion is secured to a multi-layered, elongated coil spring arrangement to permit twisting control of said catheter tip within a mammalian body component.

13. The catheter tip apparatus as recited inclaim 1, wherein said reflective surfaces are unitary portions of said housing.

14. The catheter tip apparatus as recited inclaim 13 wherein said housing has a proximal end and a distal end, and said proximal end mates with a housing enclosure, said enclosure providing a securement means for said energy collecting fiber and said housing provides a securement means for said delivery fiber.

15. The catheter tip apparatus as recited inclaim 14, wherein said housing enclosure attached to said proximal end of said housing has a longitudinally directed elongated slot therein, said slot being in radial alignment with said reflective surfaces formed on said housing to permit transmission and collection of radiant energy via said respective reflective surfaces to a computerized analysis system.

16. The catheter tip apparatus as recited inclaim 1, wherein said housing comprises a cylindrically shaped member having said first and second reflective surfaces machined thereon, and wherein said first and second reflective surfaces are non-parallel with respect to one another.

17. The catheter tip apparatus as recited inclaim 16, wherein said first and second fibers are diametrically oppositely aligned with respect to one another about a longitudinal axis of rotation of said housing, to minimize eccentricity of rotation of said catheter housing during rotation of said housing in a body tissue.

18. The catheter tip apparatus as recited inclaim 1, wherein said housing includes a reflective surface which is bendable to effect directional change of an energy beam reflecting therefrom.

19. The catheter tip apparatus as recited inclaim 18, wherein said housing has accumulation components defining a fiber alignment slot for miniaturization of said tip.

20. A catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, comprising:

an elongated housing having a longitudinal axis of rotation, said housing having a first reflective surface disposed thereon;

a second reflective surface disposed on said housing distally of said first reflective surface and in axial alignment therewith; and

a first light conductive fiber in light-coupled communication with said first reflective surface and a second light conductive fiber in light-coupled communication with said second reflective surface, said first light conductive fiber in communication being in communication with a controlled analytical-light-generating source and said second light conductive fiber being in communication with a light-collection analysis device.

21. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface is dimensionally larger than said second reflective surface.

22. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface is curvilinear.

23. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface is non-parallel with respect to said second reflective surface.

24. The catheter tip apparatus as recited inclaim 20, wherein at least one of said first and second reflective surfaces are spaced apart from said light conductive fibers.

25. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface is disposed radially within and spaced from the perimeter of said housing to permit a spreading of a light beam from said first reflective surface onto said body tissue.

26. The catheter tip apparatus as recited inclaim 24, having an index matching fluid arranged between a distal end of said conductive fiber and said reflective surface.

27. The catheter tip apparatus as recited inclaim 24, wherein said reflective surface is positioned in a holding pocket arranged in said housing.

28. The catheter tip apparatus as recited inclaim 27, wherein said reflective surface comprises a mirrored member.

29. The catheter tip apparatus as recited inclaim 27, wherein said holding pocket is utilized to align said reflective surface with respect to said housing.

30. The catheter tip apparatus as recited inclaim 20, wherein said conductive light fibers are each individually arranged within a bore disposed within said housing.

31. The catheter tip apparatus as recited inclaim 20, wherein said light delivery fibers are equally diametrically opposed about said axis of rotation of said housing to provide balance thereto and minimize eccentricity during rotation thereof.

32. The catheter tip apparatus as recited inclaim 20, wherein said first reflective surface and said second reflective surface are disposed at an angle proportional to the numerical aperture of said first and second fibers, to yield a light beam with adjacent edges that are parallel to one another, to permit a distance independent delivery reflector-collector reflector separation.

33. A catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, comprising:

an optically transparent sheath enclosed elongated housing having a longitudinal axis of rotation, said housing having a first reflective surface disposed thereon;

a second reflective surface disposed on said housing distally of said first reflective surface and in axial alignment therewith;

a first light conductive fiber in light coupled communication with said first reflective surface and a second light conductive fiber in light coupled communication with said second reflective surface, said first light conductive fiber in communication being in communication with a controlled analytical-light generating source and said second light conductive fiber being in communication with a light-collection analysis device; and

a generally curvilinear cover arranged to mate over a distal portion of said housing to enclose said reflective surfaces, said cover having at least one opening on an annular surface thereof to permit light delivery to said body tissue, and to permit light collection therethrough upon reflection from said body tissue.

34. The catheter tip apparatus as recited inclaim 33, wherein at least one of said reflective surfaces comprises a mirrored member.

35. The catheter tip apparatus as recited inclaim 34, wherein each of said light conductive fibers has a distal end arranged within said housing, and said at least one of said light conductive fibers is in abutting relationship with a non-reflective surface of said mirrored member.

36. The catheter tip apparatus as recited inclaim 33, wherein at least one of said reflective surfaces is disposed in a holding pocket.

37. The catheter tip apparatus as recited inclaim 36, wherein said reflective surface is secured in said holding pocket by an adhesive.

38. The catheter tip apparatus as recited inclaim 33, wherein an index matching fluid is disposed about said reflective surfaces to minimize back reflections thereto, from said outer sheath.

39. A catheter tip apparatus arranged in a catheter for the delivery and collection of an energy signal to permit subsequent computerized analysis of body tissue by the collected signal, comprising:

an optically transparent sheath enclosed elongated housing having a longitudinal axis of rotation, said housing having a first reflective light delivery surface disposed thereon;

a first reflective light collection surface disposed on said housing distally of said first reflective light delivery surface and in axial alignment therewith;

a first light conductive fiber in light coupled communication with said first reflective light delivery surface and a second light conductive fiber in light coupled communication with said first reflective light collection surface, said first light conductive fiber in being in communication with a controlled analytical-light generating source and said second light conductive fiber being in communication with a light-collection analysis device; and

a second reflective light collection surface disposed on said housing distally of said first reflective light collection, said second reflective collection surface also in communication with said controlled analytical-light generating source and in axial alignment therewith; said first and second reflective surfaces arranged to permit deep tissue light energy penetration and collection and analysis thereby.

40. The catheter tip apparatus as recited inclaim 39, wherein said first and second light collection surfaces collect light emitted from a common light delivery source.

41. A method of delivering and collecting a tissue-striking light energy signal from a first light bearing member and adjacent delivery beam redirecting member and returning said light energy signal to a collection beam redirecting member adjacent a second light bearing member for analysis and tissue treatment, in a light bearing arrangement, including:

spacing said collection beam redirecting member distally of said delivery beam redirector member in a sheath enclosed elongated catheter housing tip, said housing having a longitudinal axis;

disposing said beam redirecting members at an angle with respect to said longitudinal axis of said elongated housing proportional to a numerical aperture of said first and second energy fibers.

42. The method as recited inclaim 41, including:

bathing said reflectors in an index matching fluid to minimize back reflection in said sheath enclosed housing.

43. The method as recited inclaim 41, including:

directing said delivery light energy signal and said collection light energy signal so as to yield adjacent edges thereof that are parallel.

44. The method as recited inclaim 41, including:

delivering and collecting light from common fibers in said light fiber bearing arrangement.

45. The method as recited inclaim 41, wherein said numerical apertures for each of said beam redirectors are different from one another.

46. The method as recited inclaim 41, wherein said beam redirectors are reflectors.

47. The method as recited inclaim 41, wherein said beam bearing members comprise optical fibers.

48. The method as recited inclaim 41, wherein said beam bearing members comprise waveguides.