Needle catheter using optical spectroscopy for tumor identification and ablation

Abstract

The present invention relates to a catheter for forming enhanced ablation lesions, the catheter utilizing a needle electrode assembly and employing diffuse reflectance optical spectroscopy, which includes optical transmission and refraction spectroscopy before, during and after ablation to estimate tissue properties including malignant tumors and / or necrosis. The catheter includes an elongated catheter body, a control handle and a needle electrode assembly capable of longitudinal movement, and one or more optical waveguides extending from the control handle and passing through the catheter body, wherein the needle electrode assembly is suitable for penetrating and ablating tissue at the distal end of the catheter, and at least one optical waveguide is suitable for collecting light refracted from tissue at or near the distal end of the catheter. The integrated ablation and spectroscopy system of the present invention includes a radio frequency generator, a light source and an optical analyzer suitable for analyzing the light collected by at least one optical waveguide.

Description

Technical Field

[0001] The present invention relates to catheters, and in particular to pulmonary catheters for ablation and tissue diagnosis. Background Art

[0002] Radiofrequency (RF) ablation of the heart and other tissues is a well-known method for forming thermal lesions at the tip of the electrode. Radiofrequency current is delivered between a skin (ground) patch and the electrode. The resistance at the electrode-tissue interface results in direct resistive heating of a small area, the size of which depends on the size of the electrode, the electrode-tissue contact, and the current (density). Tissue heating also results from conduction of heat within the tissue to a larger area. Tissue heating exceeding a threshold of approximately 50 to 55°C is irreversibly damaged (ablated).

[0003] Resistive heating is caused by energy absorption due to resistance. Energy absorption is related to the square of the current density and is inversely proportional to tissue conductivity. Current density varies with conductivity and voltage and is inversely proportional to the square of the radius of the ablation electrode. Therefore, energy absorption varies with conductivity, the square of the applied voltage, and is inversely proportional to the fourth power of the electrode radius. Therefore, resistive heating is most affected by radius and penetrates very small distances from the ablation electrode. The remainder of the ablation lesion is formed by thermal conduction from the resistively heated area. This imposes limitations on the size of the ablation lesion that can be delivered from the surface electrode.

[0004] Theoretical approaches for increasing the lesion would include increasing electrode diameter, increasing the area of ​​electrode-tissue contact, increasing tissue conductivity, and penetrating tissue to achieve greater depth and to increase contact area, and delivering radiofrequency until maximum lesion size has been achieved (60 to 90 seconds for full maturity).

[0005] Electrodes are introduced into the tissue of interest either directly (for superficial / skin structures), surgically, endoscopically, laparoscopically, or using percutaneous transvascular (catheter-based) access. Catheter ablation is a well-described and commonly performed procedure by which many arrhythmias are treated. Needle electrodes have been described for percutaneous or endoscopic ablation of solid organ tumors, lung tumors, and abnormal neural structures.

[0006] Catheter ablation is sometimes limited by insufficient lesion size. Intravascular tissue ablation results in heating not only of the tissue, but also of the electrode. When the electrode reaches a critical temperature, denaturation of blood proteins causes coagulant formation. Impedance can then rise and limit current delivery. Within the tissue, excessive heating can cause steam bubble formation (steam "pops"), which carries the risk of uncontrolled tissue destruction and undesirable perforation of body structures. In cardiac ablation, clinical success is sometimes hampered by insufficient lesion depth and transverse diameter, even when using catheters with actively cooled tips. Theoretical solutions currently include increasing electrode size (increasing contact surface and increasing convective cooling by blood flow), improving electrode-tissue contact, actively cooling the electrode with fluid injection, changing the material composition of the electrode to improve current delivery to the tissue, and pulsing the current delivery to allow intermittent cooling.

[0007] The needle electrode improves contact with the tissue and allows deep penetration of the current delivery to the area of ​​interest. Ablation can still be hampered by the small surface area of ​​the needle electrode, so that heating is performed at low power and a small ablation lesion is formed. An improved catheter with needle ablation is disclosed in U.S. Pat. No. 8,287,531, the entire disclosure of which is hereby incorporated by reference.

[0008] The need and demand for accurate non-invasive methods for determining biological properties of tissues is well documented. Accurate non-invasive determination of various disease states may allow for faster, more convenient screening and diagnosis, thereby allowing for more effective treatment. Methods and apparatus employing optical spectroscopy for determining tissue properties are known. For example, U.S. Patent No. 7,623,906 discloses a method and apparatus for diffuse reflectance spectroscopy including a mirror control device that allows a spectroscopic analyzer to receive diffuse light reflected by tissue. U.S. Patent No. 7952719 discloses an optical catheter configuration combining Raman spectroscopy with optical fiber-based low-coherence reflectance. U.S. Patent No. 6,377,841 discloses the use of optical spectroscopy for brain tumor demarcation.

[0009] The portion of light incident on tissue may be transmitted through the tissue, absorbed as heat, refracted, specularly reflected, and diffusely reflected. Light that undergoes multiple refractions within tissue may contain information about a biological property of interest.

[0010] In the absence of a catheter suitable for both tissue diagnosis and ablation, using a separate ablation catheter after tissue diagnosis (including diagnosis by optical spectroscopy) can increase the cost and duration of the procedure and create the risk that the ablation catheter may not be able to return to the exact diagnostic location to deliver ablation energy.

[0011] Therefore, it is desirable to have a catheter with at least one electrode needle suitable for both ablation and optical spectroscopy so that tissue diagnosis and ablation can be performed with a single catheter. Such a catheter would provide a "see and treat" device that would reduce procedure time and significantly reduce, if not eliminate, the risk of not returning to the exact biopsy location to deliver ablative therapy. Summary of the invention

[0012] The present invention solves the above problems by providing a catheter that forms an enhanced ablation lesion using a needle electrode assembly and employs optical spectroscopy, which includes transmission and refraction spectroscopy before, during or after ablation to estimate tissue properties, which tissue properties include malignant tumors and / or necrosis. The catheter includes an elongated catheter shaft, a control handle and a needle electrode assembly, which extends through the catheter shaft and the control handle, and the control handle can be advanced distally or retracted proximally relative to the catheter shaft for irradiating, penetrating and ablating a target tissue site. The distal end of the needle electrode assembly is suitable for penetrating the tissue surface and for ablating tissue at a depth below the tissue surface. The distal end of the needle electrode assembly is also suitable for irradiating tissue and collecting optical data by providing at least one waveguide including, for example, an optical fiber, which waveguide can transmit light energy from the catheter to an optical analyzer, such as a spectrometer. In this regard, the waveguide has a distal end that is substantially adjacent to the distal end of the needle to emit light energy onto or into the target tissue. The light energy that has interacted with the target tissue is detected by the same waveguide or another collector waveguide. One or more waveguides may be housed in a needle electrode assembly or mounted in a tip electrode provided at the distal end of a catheter.

[0013] The present invention includes an integrated catheter-based ablation and spectroscopy system having the aforementioned catheter, a radiofrequency generator for providing radiofrequency energy to a needle electrode assembly, a light source for providing light energy to illuminate the target tissue, and an optical analyzer (e.g., a spectrometer) for detecting and analyzing optical data collected by the waveguide. In this regard, it should be understood that a spectrometer is any instrument for detecting the characteristics of light that are part of the electromagnetic spectrum, typically its wavelength, frequency, or energy. The measured characteristics are typically, but not limited to, light intensity, but other variables such as polarization may also be measured. Technically, a spectrometer can function in any range of light, but most typically operates in a specific region of the electromagnetic spectrum.

[0014] The system may also include a patient interface unit and a communication (COM) unit, a processor and a display, wherein the COM unit provides ECG, electrogram acquisition, amplification, filtering and real-time tracking of the electronics of the distal tip of the catheter, and the PIU allows communication with various components of the system (including signal generators, recording devices, etc.). The system may include a position pad with a magnetic field generator (e.g., a coil) to generate a magnetic field in the patient's body. The signal detected by the sensor contained in the catheter in response to the magnetic field is processed by the processor in sequence to determine the position (position and / or orientation) coordinates of the distal end of the catheter. Other signals from the catheter (e.g., tissue electrical activity and temperature) are also collected by the catheter and transmitted to the COM unit and processor via the PIU for processing and analysis.

[0015] In one embodiment, the catheter of the present invention includes an elongated catheter body, a control handle and a needle electrode assembly capable of longitudinal movement and one or more optical waveguides extending from the control handle and passing through the catheter body, wherein the needle electrode assembly is suitable for penetrating and ablating tissue at the distal end of the catheter, and at least one optical waveguide is suitable for collecting light refracted by tissue at or near the distal end of the catheter.

[0016] In a more detailed embodiment, the needle electrode assembly has an elongated proximal portion and a shorter distal "needle" portion, and at least one optical waveguide extends along or within the lumen of the proximal portion and the distal portion. The distal needle portion can be advanced and retracted through an axial channel formed in a distal tip electrode mounted on the distal end of the catheter body. A ring electrode is mounted proximal to the distal tip electrode. Each of the distal needle portion, the distal tip electrode, and the ring electrode is configured within the catheter for separate and independent selective ablation.

[0017] In a more detailed embodiment, the catheter has a transmitter optical fiber and a collector optical fiber, both of which extend through the lumen of the needle electrode assembly. Each has a distal end adjacent to the distal end of the distal needle portion, which is inclined to facilitate the distal end to pierce and penetrate the tissue. The catheter includes a flexure control handle and a needle control handle. The proximal end of the needle electrode assembly is housed in the needle control handle and is responsive to a control configured to advance the distal needle portion through the distal end of the catheter body. The needle control handle is also configured to retract the distal needle portion.

[0018] One embodiment of the integrated ablation and spectroscopy system of the present invention includes the aforementioned catheter, a radio frequency generator adapted to provide radio frequency energy to the needle electrode assembly, a light source adapted to provide light energy to the catheter waveguide, and a light analyzer adapted to analyze the light collected by at least one waveguide. The system may also include a patient interface unit, a communication unit, a processor, and a display, wherein the patient interface unit is adapted to send and receive signals from the radio frequency generator and the communication unit, wherein the communication unit is adapted to send and receive signals from the patient interface unit, wherein the processor is adapted to send and receive signals from the communication unit, and wherein the display is adapted to receive signals from the processor. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other features and advantages of the present invention will be better understood by reference to the following detailed description considered in conjunction with the accompanying drawings, in which:

[0020] Figure 1 is a perspective view of a catheter of the present invention according to one embodiment.

[0021] Figure 2A for Figure 1 A side cross-sectional view of a catheter along a first diameter including a connection between a proximal shaft and a distal shaft.

[0022] Figure 2B for Figure 1 The conduit is roughly perpendicular to Figure 2A A side cross-sectional view of a first diameter and a second diameter including a connection between the proximal shaft and the distal shaft.

[0023] Figure 2C for Figure 2A and 2B End cross-sectional view of the distal axis taken along line CC.

[0024] Figure 3 is a side cross-sectional view of a distal shaft including a needle electrode assembly of the present invention according to one embodiment.

[0025] Figure 3A for Figure 3 End cross-sectional view of the distal axis taken along line AA.

[0026] Figure 3B for Figure 3 End cross-sectional view of the distal axis taken along line BB.

[0027] Figure 4 is a side cross-sectional view of a puller wire T anchor according to one embodiment.

[0028] Figure 5 for Figure 1 Isometric view of the distal shaft of the catheter being deployed in the right atrium.

[0029] Figure 5A for Figure 5 Detailed view of the distal end of the distal shaft.

[0030] Figure 6 for Figure 1 A side cross-sectional view of a needle control handle.

[0031] Fig. 6A for Figure 6 Detailed view of area A in FIG.

[0032] Figure 6B for Figure 6 Detailed view of region B in FIG.

[0033] Figure 7 is a schematic diagram of a system of the present invention according to one embodiment.

[0034] Fig. 7A for Figure 7 Block diagram of the system.

[0035] Figure 8 is a perspective view of a catheter of the present invention according to another embodiment.

[0036] Fig. 8A for Figure 8 End cross-sectional view of the distal tip electrode taken along line AA.

[0037] Figure 8B for Fig. 8A Side cross-sectional view of the distal tip electrode taken along line BB.

[0038] Figure 8C for Figure 8B Side cross-sectional view of the distal tip electrode taken along CC.

[0039] Fig.8D for Figure 8 Side sectional view of the flexible segment taken along line DD.

[0040] Fig. 8E for Figure 8 A side sectional view of the deflection control handle taken along EE.

[0041] Figure 8F for Figure 8 Side sectional view of the needle control handle taken along FF.

[0042] Figure 8G for Figure 8 Detailed view of the connector.

[0043] Figure 8H for Fig.8D An end cross-sectional view of the flexible segment taken along line HH.

[0044] Fig. 9 for Figure 8 An isometric view of the distal shaft of a catheter being deployed in the lungs.

[0045] Fig.9A for Fig. 9 Detailed view of the distal end of the distal shaft. DETAILED DESCRIPTION

[0046] like Figure 1 As shown, the catheter 10 includes an elongated catheter body 12 having a proximal shaft 13, a distal shaft 14, a flexure control handle 16 attached to the proximal end of the proximal shaft, and a needle control handle 17 indirectly attached to the catheter body 12 proximal to the flexure control handle 16.

[0047] refer to Figure 2A and 2B , the proximal shaft 13 includes a single central or axial lumen 18. The proximal shaft 13 is flexible, i.e., bendable, but substantially incompressible along its length. The proximal shaft 13 can be of any suitable configuration and can be made of any suitable material. A currently preferred configuration includes an outer wall 22 made of polyurethane or nylon. The outer wall 22 includes an embedded braided mesh of stainless steel or the like to increase the torsional stiffness of the proximal shaft 13 so that when the flexure control handle 16 is rotated, the distal shaft 14 of the catheter 10 will rotate in a corresponding manner.

[0048] The outer diameter of the proximal shaft 13 is not critical, but is preferably no greater than about 8 French. Likewise, the thickness of the outer wall 22 is not critical. In the depicted embodiment, the inner surface of the outer wall 22 is lined with a reinforcing tube 20, which can be made of any suitable material, preferably polyimide. The reinforcing tube 20, together with the braided outer wall 22, provides improved torsional stability while minimizing the wall thickness of the catheter, thereby maximizing the diameter of the single lumen. The outer diameter of the reinforcing tube 20 is approximately the same as or slightly smaller than the inner diameter of the outer wall 22.

[0049] like Figure 2A , 2B As shown in FIGS. 2C and 2C , the distal shaft 14 includes a short section of a multi-lumen tube 19 having, for example, at least three lumens, i.e., a first lumen 30, a second lumen 31, and a third eccentric puller wire lumen 32 for unidirectional flexion and a fourth eccentric lumen 33 diametrically opposite to lumen 32 for bidirectional flexion. The tube 19 is made of a suitable non-toxic material that is preferably more flexible than the proximal shaft 13. A suitable material for the tube 19 is braided polyurethane, i.e., polyurethane with an embedded mesh of braided stainless steel or the like. The outer diameter of the distal shaft 14, like the outer diameter of the proximal shaft 13, is preferably no greater than about 8 French.

[0050] Suitable means for attaching the proximal shaft 13 to the distal shaft 14 are, for example, Figure 2A and 2B The proximal end of the distal shaft 14 includes an inner counterbore 24 that receives the outer surface of the reinforcement sheet 20. The distal shaft 14 and the proximal shaft 13 are attached by glue or the like. Other methods for attaching the proximal shaft 13 to the distal shaft 14 may be used according to the present invention.

[0051] The reinforcement tube 20 is held in position relative to the outer wall 22 at the proximal shaft 13. In a suitable configuration of the proximal shaft 13, a force is applied to the proximal end of the reinforcement tube 20, which causes the distal end of the reinforcement tube 20 to be firmly pressed against the counterbore 24. While under compression, a first glue joint is formed between the reinforcement tube 20 and the outer wall 22 by a fast drying glue (e.g., super glue RTM.). Then, a second glue joint is formed between the proximal end of the reinforcement tube 20 and the outer wall 22 using a slower drying but stronger glue (e.g., polyurethane).

[0052] The depicted catheter includes a mechanism for flexing the catheter body 12. In the depicted embodiment, the catheter is adapted to be bidirectionally flexed with a first puller wire 42 extending into the puller wire lumen 32 and a second puller wire 43 extending into the puller wire lumen 33. The pullers 42 and 43 are anchored in the flexure control handle 16 at their proximal ends and anchored at or near the distal end of the distal shaft 14 at their distal ends. The pullers are made of any suitable metal, such as stainless steel or nitinol, and are preferably coated with Teflon.RTM or the like. The coating makes the pullers lubricating. Each puller wire preferably has a diameter in the range of from about 0.006 inches to about 0.010 inches.

[0053] To achieve flexure along the distal shaft 14, each puller wire is surrounded by a corresponding compression coil 44, which extends from the proximal end of the proximal shaft 13 and terminates at or near the proximal end of the distal shaft 14. Each compression coil 44 is made of any suitable metal, preferably stainless steel. The compression coil 44 itself is tightly wound to provide flexibility, i.e., bendability, but resistance to compression. The inner diameter of the compression coil 44 is preferably slightly larger than the diameter of the puller wire. For example, when the puller wire has a diameter of about 0.007 inches, the compression coil preferably has an inner diameter of about 0.008 inches. The Teflon.RTM coating on the puller wire enables it to slide freely within the compression coil 44. Along its length, the outer surface of each compression coil 44 is covered by a corresponding flexible non-conductive sheath 26, thereby preventing contact between the compression coil 44 and any other components inside the catheter body 12. The non-conductive sheath 26 can be made of a polyimide tube. Each compression coil 44 is anchored at its proximal end by glue (not shown) to the proximal end of the reinforcement tube 20 in the proximal shaft 13. At its distal end, each compression coil is anchored in the corresponding puller wire lumen 32 and 33 by glue joint 45.

[0054] The pull wire is anchored at its distal end to the side of the distal shaft 14, such as Figure 4 As shown. In this embodiment, a T-shaped anchor 23 is used for each pull line. The anchor 23 includes a short piece of tubular stainless steel 25, such as a subcutaneous rod (stock), which is assembled on the distal end of each pull line and curled to securely fix it to the pull line. The distal end of the tubular stainless steel 25 is securely attached to a stainless steel cross piece 27, such as a stainless steel band, for example, by welding. The cross piece 27 is located in a recess 28 in the wall of the distal shaft 14, and the recess 28 extends into the second inner cavity 32. The stainless steel cross piece 27 is larger than the recess 28 and therefore cannot be pulled out through the recess. The portion of the recess 28 not filled by the cross piece 27 is filled with glue 21, etc., preferably polyurethane glue, which is harder than the material of the distal shaft 14. The rough edge of the cross piece 27 (if any) is polished to provide a smooth surface continuous with the outer surface of the distal shaft 14.

[0055] Also refer to Figure 2B Within the distal shaft 14, the puller wires 42 and 43 extend through respective protective sheaths 81 of, for example, Teflon.RTM., which prevent the puller wires from cutting into the wall of the distal shaft 14 when the distal shaft is flexed.

[0056] Any other suitable technique for anchoring the puller wires 42 and 43 in the distal shaft 14 may also be used. Alternatively, other means for flexing the distal region may be provided, such as the flexure mechanism described in US Pat. No. 5,537,686, the disclosure of which is incorporated herein by reference.

[0057] Longitudinal movement of the puller wire relative to the catheter body 12 is achieved by appropriate manipulation of the control handle 16, which causes deflection of the distal shaft 14 ( Figure 1 ). Examples of suitable control handles for manipulating a single puller wire for unidirectional flexure are disclosed, for example, in U.S. Pat. Nos. Re 34,502, 5,897,529, and 6,575,931, the entire disclosures of which are incorporated herein by reference. Suitable control handles for manipulating at least two puller wires for bidirectional flexure are described in U.S. Pat. Nos. 6,123,699, 6,171,277, and 6,183,463, the disclosures of which are incorporated herein by reference.

[0058] like Figure 3 , 3AAs shown in FIG. 3B , a needle electrode assembly 46 is provided. The needle electrode assembly 46 is used to ablate tissue while injecting saline or other fluid to conduct ablation energy and cool the needle electrode, thereby forming a theoretical increase in the effective size of the electrode. The needle electrode assembly 46 is extendable and retractable and can be moved by manipulating the needle control handle 17 ( Figure 1 ), as further described below. Figure 3 The needle electrode assembly 46 is depicted in an extended position relative to the catheter body 12, which will be used to ablate and / or irradiate tissue. The distal end of the needle electrode assembly 46 can be returned or withdrawn into the central lumen 30 to avoid damage to its distal end and / or injury to the patient, particularly during advancement of the catheter through the vasculature or lungs of the patient's body and during removal of the catheter from the body.

[0059] Needle electrode assembly 46 includes a proximal tube 53 that is directly or indirectly joined to a substantially rigid conductive distal tube or hollow needle 55, such as Figure 3 The generally rigid nature of needle 55 allows it to penetrate tissue to increase its effectiveness during ablation. In one embodiment, needle 55 is formed of nitinol or stainless steel and is Figure 3 As shown, a beveled edge 56 is preferably formed at the distal tip of the needle electrode assembly 46 to enhance its ability to penetrate tissue. The proximal tube 53 is preferably more flexible than the needle 55 to allow the proximal tube to bend as needed along the flexible proximal shaft 13 of the catheter body 12, for example, when the catheter is inserted into a vessel of the body. The proximal tube 53 of the needle electrode assembly 46 can be made of polyimide or polyetheretherketone (PEEK), and can be made of any other suitable biocompatible material, such as plastic or metal.

[0060] The proximal tube 53 of the needle electrode assembly 46 extends from the needle control handle 17, through the deflection control handle 16, through the proximal shaft 13, and into the lumen 30 of the distal shaft 14. Figure 3As shown, the distal end of the proximal tube 53 and the proximal end of the needle 55 are slightly spaced apart by a discontinuity or gap G so that various components can transition between the exterior of the proximal tube 53 and the interior of the lumen of the needle 55. The proximal tube 53 and the needle 55 are preferably coaxially mounted within an outer plastic tube 68. The outer plastic tube 68 can be glued or otherwise attached to the proximal tube 53 and the needle 55 to form a single structure that can move or slide longitudinally relative to the catheter body 12 as described below. When the needle electrode assembly 46 moves relative to the catheter body 12, the outer plastic tube 68 and the proximal tube 53 extend together through the catheter body 12 and protect the needle electrode lead 29 and the thermocouple wires 63 and 64, which are located between the proximal tube 53 and the outer plastic tube 68 and extend therebetween. The needle electrode lead 29 and the thermocouple wires 63 and 64 extend through holes (not shown) in the outer plastic tube 68 within the deflection control handle 16 and are attached to appropriate connectors, as mentioned above.

[0061] Figure 3 One arrangement for joining the outer plastic tube 68 to the proximal tube 53 and the needle 55 is shown. Specifically, a small piece of plastic tube 59 (e.g., polyimide tube) is placed over and bridges the gap G. The tube 59 is attached to the proximal and distal tubes by polyurethane glue or the like to form a single fluid passage through which saline or other fluids can pass from the lumen of the proximal tube 53 to the lumen of the needle 55. The small piece of plastic tube 59 helps protect the thermocouple wires 63 and 64 and the needle electrode lead 29. A small (e.g., non-conductive) spacer plug 73 is installed between the distal tube 55 and the distal end of the outer plastic tube 68 and glued in place. The spacer plug 73 prevents body fluids from entering the distal end of the needle electrode assembly 46.

[0062] In one embodiment, the proximal tube 53 of the needle electrode assembly 46 has an inner diameter of 0.014 inches and an outer diameter of 0.016 inches. The needle 55 has an inner diameter of 0.015 inches and an outer diameter of 0.018 inches and a length of about 1.0 inches. In addition, the distal tube 55 extends about 10 mm past the distal end of the distal shaft 14. The small plastic tube 59 has an inner diameter of 0.022 inches and an outer diameter of 0.024 inches, the outer plastic tube 68 has an inner diameter of 0.025 inches and an outer diameter of 0.035 inches, and the plastic spacer 73 has an inner diameter of 0.017 inches and an outer diameter of 0.024 inches.

[0063] Within the catheter body 12, the needle electrode assembly 46, including the proximal tube 53, the needle 55, the spacer 73, the plastic tube 59, and the outer plastic tube 68, is slidably (preferably coaxially) mounted within a protective tube 47, which lines the inner surface of the lumen 30 and is stationary relative to the catheter body 12. The protective tube 47, which is preferably made of polyimide, serves to prevent buckling of the needle electrode assembly 46 during extension and retraction relative to the catheter body 12. In addition, the protective tube 47 serves to provide a fluid-tight seal around the needle electrode assembly 46.

[0064] Other needle electrode assembly designs are contemplated within the scope of the present invention. For example, the needle electrode assembly may include a single conductive tube, such as a nitinol tube, extending from the needle control handle 17 to the distal end of the catheter. Such a design is described in U.S. Patent Application Serial No. 09 / 711,648, entitled "Injection Catheter with Needle Electrode," the disclosure of which is incorporated herein by reference.

[0065] like Figure 3 As shown, the needle electrode lead 29 is electrically connected at its distal end to the conductive distal tube or needle 55 for supplying radiofrequency energy or other suitable ablation energy to the needle. The needle electrode lead 29 is welded, soldered or otherwise attached to the outside of the needle 55, but may be attached to the needle at other locations. The needle electrode lead 29 extends generally along the interior of the proximal tube 53 and the outer plastic tube 68 through the lumen 30 of the tube 19 of the distal shaft 14 and the central lumen 18 of the proximal shaft 13.

[0066] A temperature sensor is provided for measuring the temperature of the tissue targeted by the needle electrode assembly 46 before, during, or after surgery. Any conventional temperature sensor may be used, such as a thermocouple or thermistor. In the depicted embodiment, the temperature sensor includes a thermocouple 62 formed by an enameled wire pair. One wire of the wire pair is a copper wire 63, such as a 46AWG copper wire. The other wire of the wire pair is a constantan wire 64, such as a 46AWG constantan wire. The wires 63 and 64 of the wire pair are electrically isolated from each other, except for their distal ends, which are welded together, covered with a short piece of plastic tubing 65 (e.g., polyimide) and covered with polyurethane. The plastic tube 65 is then glued or otherwise attached to the inner wall of the needle 55 of the needle electrode assembly 46, such as Figure 3As shown. Wires 63 and 64 extend out of the proximal end of needle 55 and extend into gap G to extend generally along lead 29 through lumen 30 of distal shaft 14, lumen 18 of proximal shaft 13 and into deflection control handle 16. On the proximal side of control handle 16, they are attached to a suitable connector (not shown) that can be connected to a suitable temperature monitor (not shown). Within proximal shaft 13 and deflection control handle 16, lead 29 and thermocouple wires 63 and 64 can pass through a protective tube (not shown), which can be eliminated if desired. In an alternative embodiment, the copper wire 63 of the thermocouple can also be used as a lead of needle electrode assembly 46.

[0067] Also like Figure 3 , 3A 3B, extending along with the needle electrode assembly 46 is at least one waveguide, such as a flexible optical fiber, which extends through the needle control handle 17, the flexure control handle 16, the central lumen 18 of the proximal shaft 13 and the lumen 30 of the distal shaft 14 and extends into the lumen of the needle 55 of the needle electrode assembly 46 via the gap G. The catheter 10 includes a waveguide bundle 70, for example, at least two independent waveguides. In the illustrated embodiment, the waveguide bundle includes an emitter waveguide 71 and collector waveguides 72 and 75, but it should be understood that the catheter can suitably function with only one emitter waveguide and one collector waveguide, or with a single waveguide suitable for both emitting and collecting light. The waveguides generally extend along each other and can be bonded to each other throughout the catheter body 12. The distal section of the waveguide inside the needle 55 can be attached to the inner surface of its lumen by glue or the like. The distal end of the waveguide is generally adjacent to the distal end of the needle 55 of the needle electrode assembly 46 and may be similarly angled as the distal end of the needle 55 for a smooth profile. It should be understood that the waveguide bundle 70 may include any number of waveguides as needed and desired. For example, the plurality of waveguides may be in the range of about one and six, including one central emitter waveguide and five surrounding collector waveguides or any other combination. Although the waveguides in the illustrated embodiment extend through the catheter body 12 along the outside of the proximal tube 53, it should be understood that they may extend through the lumen of the proximal tube if needed or appropriate.

[0068] like Figure 5 and 5A As shown, the emitter waveguide 71 is adapted to deliver light energy to the distal end of the needle 55, which has been inserted into the target tissue 102 in the right atrium of the patient's heart. The light energy 112 that exits the waveguide may be transmitted light energy, light energy absorbed as heat, and / or refracted light energy 118. Light refracted by the tissue back onto the distal ends of the collector waveguides 72 and 75 is collected and transmitted proximally along the catheter body 12 toward the handles 16 and 17.

[0069] According to a feature of the present invention, the waveguide bundle 70 and the needle 55 are arranged at the distal end of the distal shaft 14 so that they are longitudinally parallel, coextensive and / or coaxial for adapting their respective distal ends to at least target, contact and / or pierce a selected target tissue site. That is, by closely aligning the distal end of the waveguide with, being located inside or surrounding the needle 55, it is ensured that the biopsy location identified and analyzed by the waveguide will be almost identical to the location ablated by the needle electrode assembly.

[0070] like Figure 2A , 2B As shown in FIG. 3 , within the catheter body 12, the needle electrode assembly 46, electrode lead wires 29, thermocouple wires 63 and 64, and waveguide bundle 70 (collectively referred to herein as the “outer plastic tube assembly (OPTA) 68A”) extending through the outer plastic tube 68 are slidably received within the protective tube 47, which is stationary relative to the catheter body 12. That is, the OPTA 68A is able to move or slide longitudinally relative to the protective tube 47. Within the deflection control handle 16, the protective tube 47 and the OPTA 68A extend into the protective shaft 66 ( Figure 1 ), the protective shaft 66 may be made of polyurethane.

[0071] Longitudinal movement of the OPTA 68A, or at least the needle electrode assembly 46 (and longitudinal movement of the waveguide bundle 70 along it so they do not break when the needle electrode assembly is extended or retracted) is accomplished using the needle control handle 17. The OPTA 68A and protective tube 47 extend from the deflection control handle 16 to the needle control handle 17 within the protective shaft 66.

[0072] exist Figure 6 In the illustrated embodiment of the present invention, the needle control handle 17 includes a generally cylindrical outer body 80 having a proximal end 80P and a distal end 80D, a longitudinal piston chamber 82 extending partially therethrough, and a longitudinal needle channel 83 extending partially therethrough. The piston chamber 82 extends midway into the handle 17 from the proximal end 80P of the outer body 80, but does not extend beyond the distal end 80D of the outer body. The needle channel 83 having a diameter less than the diameter of the piston chamber 82 extends from the distal end of the piston chamber to the distal end 80D of the outer body 80.

[0073] A piston 84 having a proximal end 84P and a distal end 84D is slidably mounted in the piston chamber 82. A proximal fitting 86 is mounted in the proximal end 84P of the piston 84 and is securely attached to the proximal end 84P of the piston 84. The proximal fitting 86 includes a tubular distal region 87 extending distally from the body of the proximal fitting and extending into the proximal end 84P of the piston. The piston 84 has an axial passage 85 that is coaxial with and connected to an axial passage 89 formed in the proximal fitting 86. The OPTA 68A extends through the axial passages 85 and 89, as described in more detail below. A compression spring 88 is mounted in the piston chamber 82 between the distal end 84D of the piston 84 and the distal end of the piston chamber 82. The compression spring 88 may be disposed between the piston 84 and the outer body 80 , or may have one end contacting or fixed to the piston 84 and the other end contacting or fixed to the distal end 80D of the outer body 80 .

[0074] From the deflection control handle 16, the OPTA 68A and the protective shaft 66 extend proximally into the distal end of the needle channel 83 of the needle control handle 17. Fig. 6A As shown, the needle channel 83, OPTA 68A and protective shaft 66 extend into a first metal tube 90, which may be made of stainless steel. If desired, the first metal tube 90 may alternatively be made of a rigid plastic material. The first metal tube 90 is fixed to the outer body 80 of the needle control handle 17 via a set screw 101 or any other suitable means. The protective shaft 66 terminates at its proximal end within the first metal tube 90.

[0075] The second metal tube 91 (with its distal end 91D received) is preferably provided coaxially inside the proximal end 90P of the first metal tube 90, wherein the distal end 91D abuts the proximal end of the protective shaft 66. The second metal tube 91 is fixed in a suitable position relative to the first metal tube 90 and is therefore also fixed to the outer body 80 by means of a set screw 101. The second metal tube 91, like the first metal tube 90, may alternatively be made of a rigid plastic material. Figure 6B As shown, the second metal tube 91 terminates at its proximal end 91P, which is located distally of the proximal end of the compression spring 88 in the neutral state and / or distally of the distal end 84D of the piston 84 in the neutral state. Therefore, the OPTA 68A extends through the axial passage 85 of the piston 84. The first metal tube 90 serves as a protective sheath for ensuring coaxial alignment of the proximal end of the protection shaft 66 and the distal end of the second metal tube 91 in abutment connection.

[0076] The proximal end of the OPTA 68A is received in the axial passage 89 of the tubular distal end 87 of the proximal fitting 86. The protective tube 47 terminates at its proximal end in the tubular distal region 87, which exposes the proximal end of the OPTA 68A for secure attachment to the inner surface of the axial passage 89 by glue or the like. Thus, the piston 84 and the OPTA 68A are coupled to the proximal fitting 86 for longitudinal movement relative to the second metal tube 91, the first metal tube 90, and the outer body 80. Thus, when the piston 84 is distally (towards) relative to the outer body 80, the piston 84 is moved. Figure 6 When the OPTA 68A moves distally relative to the catheter body 12, the needle electrode assembly 46 is advanced for ablation and / or spectroscopy.

[0077] Within the proximal fitting 86, the proximal tube 53 extends out of the outer plastic tube 68 and into the first protective sheath 15 and is connected to a Luer connector 65 which is connected to an irrigation pump or other suitable fluid infusion source 119, such as Figure 7 Similarly, the needle electrode lead wire 29 and the thermocouple wires 63 and 64 extend out of the outer plastic tube 68 and into the second protective sheath 36, as shown. Figure 7 As shown, the second protective sheath 36 is connected to a suitable connector 67, such as a 10-pin electrical connector, for connecting the needle electrode lead wires to the ablation energy source and the thermocouple wires to a suitable monitoring system. The transmitter waveguide 71 extends out of the outer plastic tube 68 and into the third protective sheath 35, such as Figure 7 As shown, the third protective sheath 35 is connected to a suitable light source, which may be a lamp, a light emitting diode (LED) or a plurality of lasers. The collector waveguides 72 and 75 extend out of the outer plastic tube 88 and into the fourth protective sheath 37, as shown. Figure 7 As shown, the fourth protective sheath 37 is connected to a suitable light analyzer (eg, a spectrometer) to process the collected light.

[0078] In use, a force is applied to the piston 84 to cause distal movement of the piston relative to the outer body 80, which compresses the compression spring 88. This movement causes the OPTA 68A (including the needle electrode assembly 46 and the waveguide bundle 70) to move distally relative to the outer body 80, the protective shaft 66, the protective tube 47, the proximal shaft 13, and the distal shaft 14, respectively, so that the distal end of the distal tube 55 of the needle electrode assembly 46 extends outboard of the distal end of the distal shaft 14. When the force is removed from the piston 84, the compression spring 88 expands and pushes the piston proximally to its original position, causing the distal end of the distal tube 55 of the needle electrode assembly 46 to retract into the distal shaft 14 along with the distal end of the waveguide bundle 70. Upon distal movement of the piston 84, the proximal tube 53 and other plastic tubes 68 move distally into the protective tube 47 to prevent the proximal tube 53 and the outer plastic tube 68 from buckling within the axial passage 85.

[0079] The piston 84 also includes a longitudinal slot 100 extending along a portion of its outer surface. A securing device 102 (such as a set screw, pin, or other locking mechanism) extends radially through the outer body 80 and into the longitudinal slot 100. This design and set screw limit the distance that the piston 84 can slide proximally out of the piston chamber 82. When the needle electrode assembly 46 is in the retracted position (e.g., Figure 6 As shown), the fixing device 102 is preferably located at or near the distal end of the longitudinal slot 100.

[0080] The proximal end of the piston 84 has a threaded outer surface 104. A circular thumb control 106 is rotatably mounted on the threaded outer surface 104 at the proximal end of the piston 84. The thumb control 106 has a threaded inner surface 108 that interacts with the threaded outer surface 104 of the piston 84 so that the longitudinal position of the thumb control 106 relative to the proximal end 80P of the outer body 80 is adjustable. The thumb control 106 acts as a stop, thereby limiting the distance that the piston 84 can be pushed distally into the piston chamber 82 and, therefore, the distance that the needle electrode assembly 46 can extend out of the distal end of the catheter body 12. The threaded surfaces of the thumb control 106 and the piston 84 allow the thumb control to move closer to or away from the proximal end 80P of the outer body 80 so that the extension distance of the needle electrode assembly 46 can be controlled by the physician. A fixing device (such as a tension screw 109) is provided in the thumb control 106 to control the tension between the thumb control and the piston 84 for locking and releasing the longitudinal position of the thumb control on the proximal end 84P of the piston. Those skilled in the art will recognize that the thumb control 106 can be replaced by any other mechanism that can act as a stop to limit the distance that the piston 84 extends into the piston chamber 82, which is optional but preferred, and the stop is adjustable relative to the piston.

[0081] In the depicted embodiment, Figure 3 As shown, the catheter also includes at least one position sensor 77. The position sensor 77 is used to determine the coordinates of the distal end of the distal shaft 14. Specifically, the position sensor 77 is used to monitor the precise position of the distal end of the catheter in the patient's body. The position sensor 77 is connected to a corresponding sensor cable 74. The sensor cable 74 extends through the lumen 31 ( Figure 2C), and extends through the distal shaft 13 in a protective tube (not shown), then extends into the flexure control handle 16 and extends out of the proximal end of the flexure control handle in the umbilical cord (not shown) to a sensor control module (not shown) containing a circuit board (not shown). Alternatively, the circuit board may be housed in the control handle 16, for example, as described in U.S. Patent No. 6,024,739, the disclosure of which is incorporated herein by reference. The sensor cable 74 includes a plurality of wires wrapped in a plastic covering sheath. In the sensor control module, the wires of the sensor cable 74 are connected to the circuit board. The circuit board amplifies the signal received from the position sensor 77 and transmits it to the computer in a computer-readable form through the sensor connector at the proximal end of the sensor control module. In addition, since the catheter is designed for single use only, the circuit board may include an EPROM chip that shuts down the circuit board approximately twenty-four hours after the catheter is used. This prevents the catheter, or at least the position sensor 77, from being used twice.

[0082] Position sensor 77 may be an electromagnetic position sensor. For example, position sensor 77 may include a magnetic field responsive coil, as described in U.S. Patent No. 5,391,199, or a plurality of such coils, as described in International Publication WO 96 / 05758. The plurality of coils is capable of determining six-dimensional coordinates (i.e., three position coordinates and three orientation coordinates) of position sensor 77. Alternatively, any suitable position sensor known in the art may be used, such as an electrical sensor, a magnetic sensor, or an acoustic sensor. Suitable position sensors for use with the present invention are also described in, for example, U.S. Patent Nos. 5,558,091, 5,443,489, 5,480,422, 5,546,951, and 5,568,809, International Publication Nos. WO 95 / 02995, WO 97 / 24983, and WO 98 / 29033, and in U.S. Patent Application Serial No. 09 / 882,125, filed on June 15, 2001, entitled “Position Sensor Having Core with High Permeability Material,” the disclosures of which are incorporated herein by reference.

[0083] like Figure 7 and 7AAs shown, the catheter 10 can be used with an integrated ablation and spectroscopy system 200. In the illustrated embodiment, the system includes a radio frequency generator 202, a patient interface unit 203, a communication (COM) unit 204, a position pad 206, a processor 207, an input device (e.g., a keyboard) 211, and a display 208. The COM unit 204 provides an electronic device for ECG, electrogram acquisition, amplification, filtering, and real-time tracking of the distal tip of the catheter. The PIU 203 allows communication with various components of the system 200, including a signal generator, a recording device, etc. The position pad 206 includes a magnetic field generator (e.g., a coil) and is generally positioned below the patient's body to generate a magnetic field in the patient's body. In response to these magnetic fields, a position sensor 77 housed in the distal end of the catheter generates an electrical signal, which is received by the PIU 203 and transmitted to the COM unit 204 and processed by the processor 207 to determine the position (position and / or orientation) coordinates of the distal end of the catheter. The processor 207 uses these coordinates to drive the display 208 to show the position and status of the catheter. Other signals of the catheter 10 (e.g., tissue electrical activity and temperature) are also transmitted to the COM unit 204 and the processor 207 via the PIU 203 for processing and analysis, including a 3-D map of the patient's heart shown on the display 208. This position sensing and processing method is described in detail in, for example, PCT International Publication WO 96 / 05768 (the entire disclosure of which is incorporated herein by reference) and is implemented in the CARTO system manufactured by Biosense Webster Inc. (Diamond Bar, California).

[0084] With respect to ablation, the RF generator 202 supplies RF ablation energy to the needle electrode assembly 46 of the catheter 10 via the PIU 203. With respect to spectroscopy, the system 200 also includes a light source 209 that provides incident light energy to the catheter 10 via the emitter waveguide 71. The light collected by the collector waveguides 72 and 75 is transmitted to the spectrometer 210, which provides representative signals to the processor 207, which processes the signals to determine various parameters and / or characteristics of the illuminated target tissue. The system may include a first foot pedal 205A connected to the PIU 203 for acquiring the catheter position point, and a second foot pedal 205B connected to the RF generator 202 for activating / deactivating the RF generator 202.

[0085] To use the catheter of the present invention, an electrophysiologist may introduce a guide sheath and dilator into the patient, as is generally known in the art. A guide wire may also be introduced into the catheter as appropriate for such use. Figure 5 As shown, the catheter can be introduced into the right atrium (RA) via the inferior vena cava (IVC). To reach the left atrium (LA), the catheter is passed through the septum.

[0086] Through the guide sheath, the entire catheter body 12 can be passed through the patient's vasculature to the desired position. Once the distal end of the catheter reaches the desired position (e.g., right atrium RA), the guide sheath is withdrawn to expose the distal shaft 14. The thumb control 61 of the control handle 16 can be manipulated as needed to bend the distal shaft 14 into place. After the distal end of the catheter body 12 is positioned at the target tissue, the thumb control 106 is pressed to advance the piston 84 of the needle control handle 17. The positioning screw 102 can be used to releasably lock the piston 84 in a selected longitudinal position relative to the outer body 84 so as to keep the distal end of the needle at a specific depth in the tissue. As the piston is advanced distally, the OPTA 68A is advanced distally to deploy the needle 55 through the distal end of the catheter and expose it to the target tissue. Light energy is transmitted into the target tissue through the transmitter waveguide 71 and the scattered light energy is collected by the collector waveguides 72 and 77. The collected light is transmitted proximally along the catheter body 12 through the deflection control handle 16 and the needle control handle 17 and to the spectrometer 210 for analysis.

[0087] Radiofrequency energy can be applied to the needle electrode assembly 46 to energize the needle 55 for ablation to form ablation lesions, including ablation lesions that are larger than those formed by contact of the tissue surface electrodes. Irrigation fluid can also be provided at the ablation site via a fluid source and a pump 119, which provides fluid that is transported through the inner cavity of the proximal tube 53 and the needle 55. Advantageously, both spectroscopy and ablation are performed using a single catheter that can remain in place so that the ablation tissue site is almost identical to the spectroscopy tissue site. In this regard, additional spectral analysis can be performed after ablation to determine whether the ablation was successfully performed. And if appropriate, additional ablation procedures can be performed again using the advantage that the ablation tissue site remains unchanged. Additional spectral analysis and additional ablation procedures can be repeated as many times as needed at the same tissue site and using a single catheter.

[0088] Figure 8 and 8A 8H show a catheter 300 of the present invention according to another embodiment. Fig. 9 and 9A As shown, catheter 300 is suitable for use in a patient's body, including an organ (e.g., lung 305), where it can assess and treat diseased tissue, including tumor 302. As described below, catheter 300 has a structure similar in many respects to previously described catheter 10, with like components having like reference numerals, but with differences and specific adaptations, including those described below.

[0089] The catheter 300 has a proximal shaft 313, a distal shaft 314, a distal tip electrode 348, a ring electrode 349, and a needle electrode assembly 346, which includes a proximal tube 353 and a distal tube or "needle" 355. The catheter 300 also includes a deflection control handle 316, a needle control handle 317 at the distal end of the handle 316, and an optical fiber connector 318 at the distal end of the handle 317.

[0090] like Fig.8D and 8H As shown, the proximal shaft 313 includes a single central or axial lumen 318 having an outer wall 322 and a reinforcing tube 320. The distal shaft 314 includes a multi-lumen tube 319 having at least four lumens 330, 331, 332, and 333. The proximal tube 353 of the needle electrode assembly 346 extends through the lumen 330. The cable 374 of the position sensor 377 extends through the lumen 331. The pull wire 342 extends through the lumen 332. The compression coil 344 surrounding the pull wire extends from the deflection control handle 316 and through the proximal shaft 313, and terminates at its distal end at a distance distal to the proximal shaft 313, such as about one-quarter of the length of the distal shaft 314. It is noted that the illustrated embodiment of catheter 300 has unidirectional flexure so only one puller wire is provided, but it should be understood that with bidirectional flexure, a second puller wire and a corresponding lumen diametrically opposite lumen 332 would be provided. Lead wires 329T and 329R, which are tip electrode 348 and ring electrode 349, respectively, extend through lumen 333.

[0091] like Fig.8D As shown, the proximal tube 353 of the needle electrode assembly 346 houses the waveguide bundle (including the emitter waveguide 371 and the collector waveguide 373), the lead wire 329, and the thermocouple wire pairs 363 and 364 of the needle 355. These components extend through a single central lumen of the proximal tube 353. Surrounding the proximal tube 353 along its length is an outer tube 368, which extends through the needle control handle 317, the deflection control handle 316, the proximal shaft 313, the distal shaft 314 and extends into the distal tip electrode 348, wherein the distal end of the outer tube 368 is anchored, as described below. Therefore, in this embodiment, the outer tube 368 is longitudinally stationary relative to the catheter and is therefore not longitudinally movable with the proximal tube 353 and the needle 355, which can be advanced and withdrawn relative to the catheter body 312 and the tip electrode 348. In one embodiment, outer tube 368 has an outer layer of polyimide and an inner layer of PTFE, proximal tube 353 is constructed of PEEK, and needle 355 is constructed of Nitinol.

[0092] At the distal end of the proximal tube 353 of the needle electrode assembly 346, the proximal end of the needle 355 is received in the lumen of the tube 353 and anchored therein by a lead 329N that extends through the proximal tube 535. The lead 329N is coiled around and welded to the proximal end 355P of the needle, which is secured to the distal end of the proximal tube 353. In addition, the waveguides 370 and 371 and the thermocouple wire pairs 633 and 634 of the needle 355 extend through the lumen of the proximal tube 353 and continue through the single central lumen of the needle 355, where they have distal ends that are generally adjacent to the beveled distal end of the needle. Thus, the needle electrode assembly 346 including the proximal tube 353 , the needle 355 , along with the waveguides 370 and 371 , the lead wire 329N, and the thermocouple wire pairs 363 and 364 has longitudinal movement within the outer tube 368 and relative to the proximal and distal shafts 313 and 314 .

[0093] refer to Figure 8B and 8C , the tip electrode 348 is mounted on the distal end of the tube 319 of the distal shaft 314. Between the tip electrode and the tube 319 is a connector tube 350, for example, a short section of tube with a single lumen suitable for accommodating and allowing reorientation of wires and / or cables extending from the distal shaft 14 to the tip electrode 348. The proximal end of the connector tube 350 receives the distal end of the tube 319, and the distal end of the connector 350 receives the proximal end of the tip electrode 348.

[0094] The tip electrode 348 is formed with a longitudinal passage 351 that is axially aligned with the lumen 330 of the distal shaft 314. The passage 351 has a larger diameter proximal portion 351P and a smaller diameter distal portion 351D. Extending through the proximal portion 351P is the distal end of a wider outer tube 368 that extends from the lumen 330 of the distal shaft 314 that is fixed in the proximal portion 351P. Extending through the outer tube 368 is the proximal tube 353 of the needle electrode assembly 346. The proximal tube 353 has a distal end that is located between the proximal and distal ends of the connector tube 318.

[0095] The distal portion 351D of the channel 351 receives the needle 355 extending from the proximal tube 353. As described above, the needle 355 is mounted on the distal end of the proximal tube 353 and is electrically connected via the lead 329N. Due to the difference in outer diameter between the proximal tube 353 and the needle 355, the junction J between the distal portion 351D and the proximal portion 351P of the channel 351 in the tip electrode 348 acts as a distal stop that limits the amount of distal advancement imparted to the needle electrode assembly 346 relative to the tip electrode 348.

[0096] The proximal end of the tip electrode 348 is formed with an outer peripheral recess, which is received in the distal end of the connector tube 318. The ring electrode 349 is mounted on the connector tube 318 in the recess. The distal end of the ring electrode 249 and the connector tube 318 are bonded to the tip electrode 348 in the recess by glue or the like (e.g., polyurethane 376). The lead wire 329R of the ring electrode and the lead wire 329T of the tip electrode are both passed from the lumen 333 of the distal shaft 314 and through the lumen of the connector tube 318. The lead wire 329R is connected to the ring electrode 349 via a hole formed in the connector tube 318. The lead wire 329T of the tip electrode 348 is welded in a first blind hole 352 formed in the proximal side of the tip electrode 348. Additionally, anchored in the first blind hole 353 is the distal end of a puller wire 342 having a short, crimped stainless steel tube 323 welded into the hole 354. A second blind hole 353 is also formed on the proximal side to receive a sensor 377 anchored therein. The biosensor cable 374 passes from the lumen 331 of the distal shaft 314 and through the lumen of the connector tube 318.

[0097] Thus, catheter 300 has at least three distinguishable electrode elements, namely, needle 355, tip electrode 348, and ring electrode 349, each with its own unique lead for separate and independent selective electrical recording and energization.

[0098] Fig. 8E and 8F One embodiment of a deflection control handle 316 and a needle control handle 317 suitable for use with the catheter 300 is shown. Figure 1 The present description of the deflection control handle 16 and the needle control handle 17 is provided herein. Most of the description applies to Fig. 8E and 8F The flexure control handle 316 and the needle control handle 317 of the present invention are shown in Figures 1 and 3, wherein similar components are identified by reference numerals having the same last two digits. Figure 8G , an optical fiber connector 378 is shown proximal to and connected to the needle control handle 317 for connecting the waveguides 371 and 372 to a light source and a spectrometer ( Figure 7 ). One or more connectors may be provided to define an isolated path for each waveguide.

[0099] The foregoing description has been presented with reference to the presently preferred embodiments of the present invention. Those skilled in the art and technology of the present invention will appreciate that changes and variations in the described structures may be practiced without intentionally departing from the principles, spirit and scope of the present invention. It should be understood by those of ordinary skill in the art that the accompanying drawings are not necessarily drawn to scale. In addition, the different features of the different embodiments may be combined as needed or as appropriate. In addition, the catheters described herein may be suitable for applying various forms of energy, including microwaves, lasers, radio frequencies and / or cryogens. Therefore, the above description should not be considered to be related only to the precise structures described and shown in the accompanying drawings, but should be considered to be consistent with and as support for the appended claims having the most comprehensive and reasonable scope.

Claims

1. A catheter, comprising: an elongated catheter body; Control handle; a needle electrode assembly extending from the control handle through the catheter body, the needle electrode assembly comprising a distal needle portion having an inner lumen and being beveled at a distal end thereof and a distal end adapted to penetrate tissue at a target site, wherein the needle electrode assembly is movable longitudinally relative to the catheter body; and at least one optical waveguide adapted to collect light refracted from the tissue at the target site; wherein the at least one optical waveguide comprises a transmitter optical fiber and a collector optical fiber extending through an inner cavity of the needle electrode assembly, each of the transmitter optical fiber and the collector optical fiber having a distal end positioned in the inner cavity of the distal needle portion and adjacent to the inclined distal end of the distal needle portion and inclined like the inclined distal end of the distal needle portion for a smooth profile.

2. The catheter according to claim 1, wherein The transmitter optical fiber is adapted to transmit light into the tissue.

3. The catheter according to claim 1, wherein: The transmitter optical fiber, at least a distal end of the collector optical fiber, and at least a distal portion of the needle electrode assembly are coupled for longitudinal movement relative to the catheter body.

4. The catheter according to claim 1, wherein The control handle has a piston adapted to longitudinally move the needle electrode assembly relative to the catheter body.

5. The catheter according to claim 4, wherein: The piston is adapted to advance the distal end of the needle electrode assembly through the distal end of the catheter.

6. The catheter according to claim 5, wherein: The piston is adapted to retract the distal end of the needle electrode assembly into the catheter.

7. The catheter according to claim 1, wherein: The catheter body includes a proximal shaft and a flexible distal shaft.

8. The catheter of Claim 1, further comprising a distal tip electrode, wherein the distal end of the needle electrode assembly is configured for advancement past the distal tip electrode.

9. The catheter of claim 3, further comprising a ring electrode.

10. A catheter, comprising: an elongated catheter body having a proximal axis and a distal axis; Control handle; a needle electrode assembly extending from the control handle through the proximal shaft and into the distal shaft, the needle electrode assembly comprising a distal needle portion having a lumen and being beveled at a distal end thereof and a distal end adapted to penetrate tissue at a target site, wherein the needle electrode assembly is longitudinally movable relative to the catheter body; at least one emitter optical waveguide adapted to provide light into the tissue at the target site; and at least one collector optical waveguide adapted to collect light refracted by the tissue at the target site; wherein the at least one emitter optical waveguide and the at least one collector optical waveguide extend through the lumen of the needle electrode assembly, each of the at least one emitter optical waveguide and the at least one collector optical waveguide having a distal end positioned in the lumen of the distal needle portion and adjacent to and angled like the angled distal end of the distal needle portion for a smooth profile.

11. The catheter according to claim 10, wherein The emitter and collector optical waveguides and the needle electrode assembly are coupled for longitudinal movement relative to the catheter body.

12. The catheter according to claim 10, wherein The control handle has a piston adapted to longitudinally move the needle electrode assembly relative to the proximal shaft and the distal shaft.

13. The catheter according to claim 12, wherein: The piston is adapted to advance the distal end of the needle electrode assembly through the distal end of the distal shaft.

14. The catheter according to claim 13, wherein The piston is adapted to retract the distal end of the needle electrode assembly proximal to the distal end of the distal shaft.

15. A system for ablation and spectroscopy, comprising: The catheter according to claim 1; a radio frequency generator adapted to provide radio frequency energy to the needle electrode assembly; a light source adapted to provide light energy into tissue at the target site; and A spectrometer is provided, the spectrometer being adapted to analyze the light collected by the at least one waveguide.

16. The system of claim 15, further comprising: Patient interface unit; Communication unit; processor; and monitor, wherein the patient interface unit is adapted to send and receive signals from the radio frequency generator and the communication unit, wherein the communication unit is adapted to send and receive signals from the patient interface unit, wherein the processor is adapted to send and receive signals from the communication unit, Wherein the display is adapted to receive signals from the processor.

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