Multi-fiber laser catheter

Claim 2

A laser catheter, for use in providing therapeutic laser energy to human heart tissue at a pre-selected tissue site, the catheter comprising: a) a catheter body having a proximal end and a distal end and an inner wall defining a lumen extending generally along a longitudinal axis of said catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within said catheter body and having a plurality of individual optical fibers to provide laser energy to the tissue site by a laser source; c) a fixation element, having a proximal end and a distal end and operably carried through said lumen extending past said distal end of said catheter body, constructed to selectively penetrate the tissue to a predetermined depth at said pre-selected tissue site and to fix said distal end of said catheter body to said tissue; and d) a plurality of temperature sensors, fixedly attached at spaced intervals along the length of said fixation element within the tissue to sense the temperature of said tissue at a plurality of tissue depths corresponding to said spaced intervals while said laser catheter is providing laser energy to said pre-selected tissue site, wherein said plurality of temperature sensors provide temperature readings correlated to the tissue depth at which each temperature sensor is located to create a temperature depth profile of the tissue.

Claim 3

The catheter of claim 1, further comprising a laser energy termination device, operably coupled to the plurality of temperature sensors and to the laser source and adapted to terminate provision of laser energy to the tissue site based on temperature readings from at least two of the temperature sensors.

Claim 4

The catheter of claim 2, wherein the termination device comprises feedback control circuitry.

Claim 5

The catheter of claim 2, wherein the termination device is triggered by an operator.

Claim 6

The catheter of claim 1, further comprising an electrophysiological mapping system operably coupled with the catheter body, the fixation element being one pole of the electrophysiological mapping system.

Claim 7

The catheter of claim 5, further comprising a metallic tip at the distal end of the catheter body, the metallic tip being a second pole of the electrophysiological mapping system.

Claim 8

The catheter of claim 1, wherein the catheter is a one-piece catheter.

Claim 9

The catheter of claim 1, wherein the catheter is a multi-piece catheter.

Claim 10

A laser catheter for use in a multi-piece catheter system, the laser catheter providing controlled laser energy effective to therapeutically denature human heart tissue at a pre-selected cardiac tissue site, the catheter comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to the tissue site by a laser source; c) substantially helically-shaped fixation means, aligned co-axially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected tissue site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; and d) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means and operably connected to the laser source, for sensing a plurality of temperatures, at depths within the cardiac tissue corresponding to the spaced intervals, while the laser catheter is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site.

Claim 11

A laser catheter for use in a multi-piece catheter system, the laser catheter providing controlled laser energy effective to therapeutically denature human heart tissue at a pre-selected cardiac tissue site, the catheter comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to the tissue site by a laser source; c) substantially helically-shaped fixation means, aligned co-axially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected tissue site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; and d) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means and operably connected to the laser source, for sensing a plurality of temperatures, at depths within the cardiac tissue corresponding to the spaced intervals, while the laser catheter is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site.

Claim 12

The catheter of claim 9, wherein the temperature signals control the irradiation of the tissue site by terminating irradiation of the site when the signals indicate that the tissue at the site has reached a predetermined temperature.

Claim 13

The catheter of claim 10, wherein the predetermined temperature is 423° K.

Claim 14

The catheter of claim 9, further comprising a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the metal tip holding the distal ends of the optical fibers in an orientation divergent from the longitudinal axis of the catheter.

Claim 15

The catheter of claim 12, further comprising access means, located toward the proximal end of the catheter body, for operable communication with the first lumen of the catheter body.

Claim 16

The catheter of claim 13, wherein the access means comprises a plurality of separate access ports, each port being in operable communication with the first lumen.

Claim 17

The catheter of claim 13, further comprising an electrically conducting wire fixably attached at a distal end to the metal tip of the catheter, the wire extending axially through the inner lumen of the catheter body to and through the access means.

Claim 18

The catheter of claim 13, further comprising means for directing a fluid cooling/flushing medium through the access means to the inner lumen of the catheter body.

Claim 19

The catheter of claim 9, wherein the fixation means is fixed within the catheter body and wherein the distal end of the fixation means extends a fixed amount beyond the distal end of the catheter.

Claim 20

The catheter of claim 9, wherein the fixation means is slidably located within the catheter body.

Claim 21

The catheter of claim 18, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

Claim 22

The catheter of claim 19, further comprising a tube aligned centrally within the control means and extending co-axially through the catheter body to the distal end of the catheter body, the tube comprising inner walls that define a second lumen, the fixation means passing through the second lumen.

Claim 23

The catheter of claim 20, further comprising a plurality of electrically conducting wires, each wire having a distal end and a proximal end, wherein the distal end of each wire is connected to a respective one of the plurality of temperature sensing means attached to the fixation means, wherein the plurality of wires is aligned axially with the second lumen, each of the plurality of wires extending through the second lumen and out from the proximal end of the catheter body.

Claim 24

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals along the fixation means within the cardiac tissue, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while laser energy is being provided to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site and to create a temperature depth profile of the cardiac tissue; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

Claim 25

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals along the fixation means within the cardiac tissue, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while laser energy is being provided to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site and to create a temperature depth profile of the cardiac tissue; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

Claim 26

The system of claim 22, wherein the temperature signals control the irradiation of the tissue site by terminating irradiation of the site when the signals indicate that the tissue at the site has reached a pre-determined temperature.

Claim 27

The system of claim 22, wherein the fixation means is slidably located within the catheter body.

Claim 28

The system of claim 24, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

Claim 29

The system of claim 25, further comprising a tube aligned centrally within the control means and extending co-axially through the catheter body to the distal end of the catheter body, the tube comprising inner walls that define a second lumen, the fixation means passing through the second lumen.

Claim 30

The system of claim 26, further comprising a plurality of electrically conducting wires, each wire having a distal end and a proximal end, wherein the distal end of each wire is connected to a respective one of the plurality of temperature sensing means attached to the fixation means, wherein the plurality of wires is aligned axially with the second lumen, each of the plurality of wires extending through the second lumen and out from the proximal end of the catheter body.

Claim 31

The system of claim 22, further comprising access means, located toward the proximal end of the catheter for operable communication with the first lumen of the catheter.

Claim 32

The system of claim 28, further comprising means for directing a fluid cooling/flushing medium through the access means to the inner lumen of the catheter body.

Claim 33

The system of claim 22, wherein the metal tip is a porous metal tip.

Claim 34

The laser catheter of claim 22, wherein the distal end of the fixation means is helically shaped.

Claim 35

The laser catheter of claim 31, further comprising mechanical control means affixed to the proximal end of the catheter and operably coupled to the fixation means for slidably extending the helically shaped distal end of the fixation means beyond the distal end of the catheter body and back within the catheter body.

Claim 36

The laser catheter of claim 32, wherein the control means rotatably moves the distal end of the helically shaped fixation means to securely fix the fixation means to the cardiac tissue.

Claim 39

The method of claim 34, wherein step (e) includes creating a temperature depth profile of the cardiac tissue at the pre-selected tissue site by a plurality of spaced temperature sensors on the fixation element.

Claim 40

The method of claim 34, further comprising electrophysiologically mapping the pre-selected tissue site with the laser catheter to determine a precise location for irradiation of tissue by the laser catheter.

Claim 41

The method of claim 36, further comprising steering the laser catheter with an externally accessible steering control device through anatomical structures to the pre-selected tissue site.

Claim 42

The method of claim 34, wherein step (b) includes irradiating the cardiac tissue with laser energy provided via a multi-fiber optic cable having a plurality of optical fibers, the optical fibers diverging from a longitudinal axis of the catheter.

Claim 43

The method of claim 38, wherein step (d) includes directing the fluid flushing medium along the plurality of optical fibers diverging from the longitudinal axis of the catheter, the flushing flow surrounding the optical fibers to thoroughly bathe the pre-selected tissue site.

Claim 46

The method of claim 40, wherein step (f) includes creating a temperature depth profile of the cardiac tissue at the pre-selected tissue site by a plurality of spaced temperature sensors on the fixation element.

Claim 47

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a porous metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

Claim 48

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a porous metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

Claim 49

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a helically-shaped distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.

Claim 50

A one-piece laser catheter system, providing controlled laser energy effective to therapeutically denature human heart tissue within a patient's heart without ablating that tissue, the catheter system comprising: a) a catheter body having a proximal end and a distal end, and an inner wall defining a first lumen extending generally along a longitudinal axis of the catheter; b) a multi-fiber optic cable having a proximal end and a distal end located within the catheter body and having a plurality of individual optical fibers to provide laser energy to a pre-selected treatment site by a laser source; c) a metal tip operably coupled to the distal end of the catheter body, the plurality of optical fibers passing through the metal tip, the distal ends of the optical fibers being held in an orientation divergent from the longitudinal axis of the catheter body by the metal tip; d) fixation means, aligned coaxially with and contained within the catheter body, for penetrating a controlled depth into cardiac tissue at the pre-selected treatment site and fixing the catheter to the site, the fixation means having a proximal end and a helically-shaped distal end and a length sufficient to extend beyond the distal end of the catheter body; e) a plurality of temperature sensing means, fixedly attached to the fixation means at spaced intervals from the distal end of the fixation means, for sensing a plurality of temperatures at depths within the cardiac tissue corresponding to the spaced intervals while the laser is providing radiant energy to the tissue site, wherein the plurality of temperature sensing means provide temperature signals which correlate to the tissue temperature at the location of each temperature sensing means, and wherein the temperature signals are used to control irradiation of the tissue site; f) electrophysiological sensing means, located on the external surface of the catheter body, for sensing the electrophysiological characteristics of cardiac tissue proximate to the sensing means; and g) steering means for guiding the catheter system through anatomical structures within the patient's body to the interior of the heart, the steering means being operatively coupled to an externally accessible steering control device for controlling steering of the catheter through the anatomical structures.