Vapor therapy systems and methods

Abstract

A vapor delivery system is provided that may include any of a number of features. One feature of the vapor delivery system is that it can apply condensable vapor energy to tissue, such as targeted tissue within a prostate, to shrink, damage, or denature the targeted tissue. In some embodiments, the vapor delivery system can include safety features including prostate capsule detection, needle alignment, deployment, and tracking, and treatment tracking. Mechanisms and methods for safe and effective treatment of prostate tissues are described herein.

Description

VAPOR THERAPY SYSTEMS AND METHODSPRIORITY CLAIM

[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 616,187, titled “VAPOR THERAPY SYSTEMS AND METHODS,” and filed on December 29, 2023, which is herein incorporated by reference in its entirety.CROSS REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to International Patent Application No. PCT / US2020 / 067532, titled “VAPOR THERAPY SYSTEMS AND METHODS,” filed December 30, 2020, International Patent Application No. PCT / US2022 / 020635, titled “VAPOR THERAPY SYSTEMS AND METHODS,” filed March 16, 2022, and International Patent Application No. PCT / US2023 / 084964, titled “PROSTATE CANCER LESION TARGETING AND VAPOR NEEDLE TIP TRACKING FOR PROSTATE BIOPSY AND VAPOR THERAPY,” filed December 19, 2023, which are all fully incorporated herein by reference.INCORPORATION BY REFERENCE

[0003] All publications, including patents and patent applications, mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.FIELD

[0004] The present invention relates to devices and related methods for treatment of prostate cancer using a minimally invasive approach.BACKGROUND

[0005] The human male prostate can be classified into three zones: the peripheral zone, transition zone, and central zone. Peripheral zone (PZ) comprises about 70% of the volume of a male’s prostate. This sub-capsular portion of the posterior aspect of the prostate gland surrounds the distal urethra and 70 to 80% of cancers originate in the peripheral zone tissue. The central zone (CZ) surrounds the ejaculatory ducts and contains about 20-25% of the prostate volume. The central zone is often the site of inflammatory processes. The transitionzone (TZ) is the site in which benign prostatic hyperplasia (BPH) develops and contains about 5-10% of the volume of glandular elements in a normal prostate but can constitute up to 80% of such volume in cases of BPH. The transition zone includes two lateral prostate lobes and the periurethral gland region. There exist natural barriers around the transition zone, i.e., the prostatic urethra, the anterior fibromuscular stroma (FS), and a fibrous plane (FP) between the transition zone and peripheral zone. The anterior fibromuscular stroma (FS) or fibromuscular zone is predominantly fibromuscular tissue.

[0006] Approximately 70% to 80% of prostate cancers originate in the peripheral zone of the prostate and may be confined to the peripheral zone. In recent years, there has been an increased interest in focal therapy for prostate cancer, treating only regions of tissue in which cancer has been found following biopsies. Prior art focal therapy treatments, such as with RF ablation energy, may not confine the treatment to the peripheral zone tissue or to tissues within the prostate.SUMMARY OF THE DISCLOSURE

[0007] A prostate treatment system is provided comprising: a system console; an introducer shaft sized and configured for transurethral access into a patient; a cartridge coupled to the introducer shaft; a vapor generator disposed in the cartridge and configured to generate a condensable vapor; a thermally insulated needle in communication with the vapor generator and slidably disposed within the introducer shaft and configured to exit the shaft into prostate tissue in an arc that is reproduced every time the needle is deployed from the shaft; a light source and digital camera configured within the shaft tip to video the urethra and the needle as it deploys and retracts; a lumen within the shaft through which sterile saline may be pumped to cool the shaft and the urethra and to flush debris from the needle and camera lens; a lumen within the shaft configured to drain flush saline and / or urine from the distal urethra that may be facilitated by attaching its proximal opening to a vacuum and which may share part or all of a lumen with the flush lumen; a flexible drive cable attached to the needle and extending from the cartridge to a linear motor disposed in the system console to provide software controlled movements of the needle to deploy into tissue, advance and retract at constant speed or in pulsed steps, or retract fully into the shaft; sensors disposed on the needle and shaft and within the cartridge, console and linear motor to measure temperatures and vapor pressure and needle and shaft locations; a Trans Rectal Ultrasound System (TRUS) to provide real time images of the prostate, shaft and vapor delivery needle during therapy; stabilizer arms that allow the TRUS probe and vapor deliverydevice cartridge to be locked into positions within the patient rectum and urethra respectively and then individually rotated and translated relative to the fixed locations of the stabilizer arms; a Needle Guidance System (NGS) that transmits and / or receives electromagnetic fields from one or more locations on one or more interventional devices such as delivery device shaft or needle, that are received and / or transmitted from one or more locations on the TRUS probe, and converts field sensor data to shaft and needle tip locations and headings relative to the TRUS probe and displays this information on TRUS images of the prostate; an overhead monitor that displays cystoscope video images, TRUS images with animations showing the locations of the vapor delivery shaft and needle and cancer targets and ablated tissue, preoperative MRI images of the prostate showing suspected cancerous tissue and data regarding system parameters; a hand held remote controller comprising actuators to control vapor delivery, needle movement, cartridge and TRUS probe movements, saline delivery functions and overhead monitor display options; saline delivery needles advanced through the patient perineum to deliver saline that cools and expands the periprostatic space during vapor delivery; and electronics disposed in the cartridge, remote controller and system console that communicate with each other and with the user to insure safe and effective delivery of vapor to targeted tissues and to prevent delivery of vapor outside of targeted tissues.

[0008] In certain examples, there is a vapor delivery system, having: a shaft configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced generally transverse to the shaft, in which the needle has exit ports at a distal end configured for vapor delivery to the prostate; a vapor source fluidly coupled to the needle; and a needle guide disposed within the shaft and configured to engage with the needle to prevent the needle from rotating relative to the shaft.

[0009] According to certain examples, the needle may include a protrusion extending along at least a portion of the needle, in which the protrusion is configured to engage with the needle guide.

[0010] According to certain examples, the protrusion may be a rod or microtube.

[0011] According to certain examples, the protrusion may be disposed along only a portion of the needle.

[0012] According to certain examples, the protrusion may be disposed along only a proximal portion of the needle and not along a distal portion of the needle.

[0013] According to certain examples, the protrusion may be disposed along only a distal portion of the needle and not along a proximal portion of the needle.

[0014] According to certain examples, the needle guide may be a plurality of needle guides disposed along opposing sides of the protrusion to stabilize the needle.

[0015] According to certain examples, the needle guide may include a lumen within the shaft sized and shaped to conform to the needle and the protrusion.

[0016] According to certain examples, the needle may include a plurality of protrusions extending along at least a portion of the needle, in which the plurality of protrusions are configured to engage with the needle guide.

[0017] According to certain examples, the plurality of protrusions may be rods or microtubes.

[0018] According to certain examples, the plurality of protrusions may be disposed on opposing sides of the needle.

[0019] According to certain examples, the plurality of protrusions may be disposed along only a portion of the needle.

[0020] According to certain examples, the plurality of protrusions may be disposed along only a proximal portion of the needle and not along a distal portion of the needle.

[0021] According to certain examples, the plurality of protrusions may be disposed along only a distal portion of the needle and not along a proximal portion of the needle.

[0022] According to certain examples, the needle guide may be a plurality of needle guides disposed along opposing sides of the plurality of protrusions to stabilize the needle.

[0023] According to certain examples, the needle guide may include a lumen within the shaft sized and shaped to conform to the needle and the plurality of protrusions.

[0024] According to certain examples, the needle may have a non-circular cross-section, and the needle guide may have a lumen sized and shaped to conform to the needle.

[0025] According to certain examples, the needle may be oval-shaped.

[0026] According to certain examples, the protrusion or plurality of protrusions may further include a lumen disposed therein.

[0027] According to certain examples, a distal tip of the shaft may have an expanded diameter relative to the rest of the shaft.

[0028] In yet other examples, there is a vapor delivery system, having: a shaft configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced generally transverse to the shaft, in which the needle has exit ports at a distal end configured for vapor delivery to the prostate; a vapor source fluidly coupled to the needle; and pull wires attached to a distal portion of the shaft andconfigured to impart deflection or curvature in the distal portion of the shaft to adjust an arc of the needle when it transitions from the delivery configuration to the deployed configuration.

[0029] According to certain examples of this system, the pull wires may be configured to impart deflection or curvature in the distal portion of the shaft, proximal to a distal tip of the shaft.

[0030] According to certain examples of this system, the deflection or curvature may provide an increased radius of curvature for the needle in the deployed configuration.

[0031] According to certain examples of this system, the system may further include an inflatable balloon at least partially surrounding an exit port of the needle on the distal portion of the shaft.

[0032] According to certain examples of this system, the inflatable balloon may be configured to prevent vapor blow-back around the needle.

[0033] According to certain examples of this system, the needle may include a vapor lumen and a pair of pull wire lumens, in which the vapor lumen may be configured to extend at least partially past the pair of pull wire lumens and towards a periphery of the needle to increase a volume of the vapor lumen.

[0034] According to certain examples of this system, the needle may have a vapor lumen, a pair of auxiliary lumens, and a pair of pull wire lumens, in which the vapor lumen may be configured to extend at least partially past the pair of auxiliary lumens and the pair of pull wire lumens towards a periphery of the needle to increase a volume of the vapor lumen.

[0035] According to certain examples of this system, the pair of auxiliary lumens may be configured to accommodate electrical leads.

[0036] In still other examples, there is a vapor delivery system, having: a shaft having a tip configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced radially outwards from the shaft; an adjustable needle guide engaged with the needle and configured to change a deployment angle of the needle; and a vapor source coupled to the needle.

[0037] According to certain examples of this system, the adjustable needle guide may be coupled to pull wires configured to change a position and / or orientation of the adjustable needle guide.

[0038] According to certain examples of this system, the preferred may be at a substantially 90 degree angle to a urethra of the patient.

[0039] According to certain examples of this system, pull wires may be coupled to needle guide elements near the tip of the shaft and may be adjusted to guide the needle on a preferred arc as the needle exits the shaft and moves into tissue.

[0040] According to certain examples of this system, the preferred arc may be at a substantially 90 degree angle to a urethra of the patient.

[0041] According to certain examples of this system, the shaft tip may be enlarged to provide a larger degree needle angle to a urethra of a patient, in which the degree needle angle may be substantially 90 degrees.

[0042] According to certain examples of this system, the system may further include an inflatable vapor seal configured to be inflated before vapor delivery to prevent vapor blowback around a puncture hole of the needle.

[0043] In still other examples, there is a needle driver system having: a motor; a delivery device cartridge having: a heating element, a needle extender means, and a needle carriage configured to receive a needle; a cable to transmit linear motion generated by the motor to the carriage; a needle having a tip to be received in a patient, in which the linear motion generated by the motor is transmitted to the delivery device carriage to deploy and retract the needle; and a shaft configured for transurethral access to a patient, in which the needle egresses through a portion of the shaft.

[0044] According to certain examples of this system, the cable may be incompressible, in which the cable may have a core wire having an adjustable amount of slop.

[0045] According to certain examples of this system, the system may include hydraulic fluid lines in place of the cable.

[0046] According to certain examples of this system, the system may further include a tapered sheath over a distal portion of the needle, in which the tapered sheath is deployed and advanced independent of the needle.

[0047] According to certain examples of this system, the system may further include access or connections for one or more of: a needle driver wire and sheath, a flush water inlet, a sterile water inlet, a flexible vapor outlet tube, and a camera.

[0048] According to certain examples of this system, the shaft may have a bent coude’ tip configured for urethral navigation, in which the needle may be configured to exit the shaft at a substantially 90 degree angle to the shaft.

[0049] According to certain examples of this system, the system may further include a sharpened rod configured to be advanced through a tip of the needle to facilitate tissue penetration, in which the tip of the needle is retractable, in which the rod facilitates passage of one or more of: (i) a gas, (ii) a fluid, or (iii) an adhesive out of the tip of the needle.

[0050] According to certain examples of this system, electric leads coupled to sensors adjacent to the tip of the needle may pass through the rod and into the delivery device cartridge, in which the sensors may be bio-impedance electrodes.

[0051] According to certain examples of this system, the system may further include a movable liner on a distal portion of the needle, the moveable liner being configured to be rotated and / or axially to transition between a first vapor hole configuration and a second vapor hole configuration.BRIEF DESCRIPTION OF THE DRAWINGS

[0052] To better understand the invention and to see how it may be carried out in practice, some preferred embodiments are next described, by way of non-limiting examples only, with reference to the accompanying drawings, in which like reference characters denote corresponding features consistently throughout similar embodiments in the attached drawings.

[0053] FIG. 1 shows an embodiment of a vapor delivery system.

[0054] FIG. 2 shows the repeatable arc of a vapor delivery needle as it exits the delivery device shaft.

[0055] FIGS. 3A-3D show an exemplary mechanism for advancing the vapor delivery needle into tissue in a single plane and in a repeatable arc.

[0056] FIG. 4 illustrates enlarged vapor delivery device shaft tip configured to enable a sharper needle arc.

[0057] FIG. 5A shows pull-wire mechanism configured to deflect the delivery device shaft tip to produce a desired needle arc.

[0058] FIG. 5B shows a pull-wire mechanism configured to deflect the vapor delivery needle.

[0059] FIGS. 6A-6B show deflectable needle guides configured to produce selected needle arcs.

[0060] FIG. 7 shows a slotted super-elastic needle insert configured to facilitate desired needle arcs.

[0061] FIG 8 shows a needle comprised of a shape memory alloy configured to be directed into selected arcs despite having rigid metal properties.

[0062] FIGS. 9-10 illustrate mechanisms to prevent vapor leaks around the vapor delivery needle and / or to support the needle during travel and therapy delivery.

[0063] FIGS. 11-13 illustrate mechanisms to control needle movement from a linear motor or hydraulic cylinder located in the system console, while reducing the size and weight of the delivery device cartridge and minimizing disposable system components.

[0064] FIGS. 14A-14C show views of a vapor delivery device cartridge.

[0065] FIGS. 15A-15B show views of a vapor delivery device distal shaft and needle.

[0066] FIG. 16 illustrates a mechanism for controlling the sharpness of a delivery device needle tip, which may also be configured to serve as a fluid injection port and a platform for bio-impedance electrodes.

[0067] FIG. 17 illustrates a device configured to deliver steam to selected locations along the delivery device needle.

[0068] FIG. 18 shows application of this invention to a transurethral tissue collection system.DETAILED DESCRIPTION OF THE INVENTION

[0069] The present disclosure is directed to the treatment of prostate cancer, and more particularly for ablating tissue identified as cancerous on pre-operative MRI scans and / or biopsies without ablating adjacent normal prostate tissues.

[0070] In general, one method for treating cancer of the prostate comprises introducing a heated vapor interstitially into the interior of a prostate, wherein the vapor controllably ablates prostate tissue. This method can utilize vapor for applied thermal energy of between 50 calories and 600 calories per individual vapor treatment (and assumes multiple treatments for each prostate lobe) in an outpatient-based procedure. The method can cause localized ablation of prostate tissue without damaging the prostatic urethra and without damaging tissue outside of the prostate gland.

[0071] The system can include a vapor delivery mechanism that delivers vapor media, including water vapor. The system can utilize a vapor source configured to provide vapor having a temperature of at least 60-140° C. The system further comprises a computer controller configured to deliver vapor for an interval ranging from 1 second to 30 seconds.

[0072] In some embodiments, the system further comprises a source of a pharmacologic agent or other chemical agent or compound for delivery before, during, or after vaportherapy. These agents include, without limitation, an anesthetic, an antibiotic or toxin such as Botox®, or a chemical agent that can treat cancerous tissue cells. The agent also can be a sealant, an adhesive, a glue, a superglue, or the like. In some embodiments an echoic or anechoic agent may be delivered with the vapor to improve its visibility under ultrasound imaging to help, for example, in locating the needle tip on the image. For example, air or other gases are echoic.

[0073] In some embodiments, a prostate treatment device can be provided comprising an introducer shaft sized and configured for transurethral access into a patient, a vapor generator configured to generate a condensable vapor, a vapor delivery needle in communication with the vapor generator and slidably disposed within the introducer shaft, and an actuator configured to move the vapor delivery needle between a retracted position inside the introducer shaft and an extended position at least partially outside of the introducer shaft, and to advance or retract the needle continuously or in steps to tissues at any location between the prostatic urethra and prostate capsule.

[0074] This disclosure is directed to safe and effective delivery of vapor to ablate targeted tissue. A vapor delivery device can include a shaft configured for transurethral access to a patient’s prostate, a vapor generator, and a vapor delivery needle that can include one or more vapor delivery ports. In one embodiment vapor is delivered through the port(s) of the vapor delivery needle to ablate cancerous or precancerous tissue. In a preferred embodiment, the vapor delivery needle is configured to puncture the prostatic urethra and advance to one or more sites within the prostate where vapor is delivered. Multiple puncture sites can be spaced apart to provide overlapping zones of tissue ablation in the prostate, without being close enough together to allow vapor delivered at a site to exit through the entry holes of the previous puncture sites.

[0075] More specifically, this disclosure is directed to navigation of a vapor delivery device, including a vapor delivery needle, into and throughout the prostate to ablate cancerous tissue without the possibility of penetrating the prostate capsule. Vapor is delivered to sites that are surrounded by tissue that has been targeted for ablation. Sensors and / or electromagnetic field transmitters on the vapor delivery device and on the TRUS (Trans-Rectal Ultrasound System) probe show the operator the location of the needle tip on the TRUS image. Animations superimposed on the ultrasound image can show the target tissue and a computed track that the needle will take when it is deployed from a given location in the urethra based upon a mathematical expression for the needle arc and the assumption that the needle cannot be deflected from the computed arc. With prior art vapordelivery devices, the operator is required to rigidly hold the delivery device in one location as the needle is deployed and advanced to the target site where vapor is delivered. Even small movements of the delivery device can cause delivery of the needle to locations from which the targeted tissue cannot be accessed. Additional needle deployments may be needed to access targeted tissues. Multiple holes through the urethra wall and prostate tissue, especially when closely spaced, may cause vapor to exit through a neighboring hole, thereby undertreating targeted tissues. If the operator moves the delivery device after needle deployment and during navigation to targeted tissues, the track made through tissue may enlarge, causing vapor to exit proximally into the urethra, causing under-treatment of targeted tissues and potential damage to the urethra wall. These concerns are addressed here.

[0076] In some embodiments, the delivery device cartridge can be attached to a stabilizer arm that is in turn rigidly attached to the patient table or to the floor adjacent to the patient table or to the system console adjacent to the patient table. A segmented stabilizer arm may be moved freely until the shaft tip, as observed on the cystoscope and ultrasound images is in a desired location. A motor then activates the stabilizer arm to lock its segments rigidly into place and hold the delivery device cartridge in a desired location and orientation. The cartridge and delivery device shaft and needle may be translated and rotated by fine adjustments to address tissue in any orientation at that location, as seen in animations projected onto the TRUS image. The needle may then be deployed through the wall of the urethra and into the prostate, advanced to a desired location where vapor is delivered. The stabilizer arm may be unlocked to move the delivery device to new locations in the prostatic urethra, then relocked for vapor delivery to new sites. In some embodiments the stabilizer arm is a robotic arm that is controlled by the system computer.

[0077] In other embodiments electrodes are disposed on the needle tip to measure tissue electrical impedance adjacent the tip. Tissue impedance, (both resistance and capacitive reactance) change abruptly as the tissue changes from cellular within the prostate to fibrous in the capsule wall. A coil of fine wire located on the needle tip, just proximal to the vapor delivery holes, comprises a tracking device that locates the needle tip relative to the TRUS image. Fine wire leads from both the impedance electrodes and coil sensor / transmitter are fed through lumens extruded into the wall of the vapor delivery needle and strain relieved as they exit the proximal end of the needle. Sensor leads exiting the needle are designed to allow for thermal expansion of the needle, and for needle movement during deployment and navigation.

[0078] Delivery of vapor to ablate selected regions or zones of the prostate where cancer has been detected can include elevating the temperature of the tissue for a time that is long enough to denature and kill the tissue cells. Temperature sensors on the tip of the vapor delivery needle enable measurement of the temperature of tissues adjacent the needle tip before vapor delivery (to ensure that tissue has not already reached ablation temperature), during vapor delivery (to ensure safe and effective delivery of vapor) and after vapor delivery (to ensure that tissues have reached ablation temperature). Small thermocouple or resistance temperature sensors may be placed at the distal end of channels formed into the wall of the delivery device needle. In some embodiments the temperature measurement is derived from the electrical resistance of the coil of wire used for needle tip tracking. In one embodiment an AC current is applied to the coil and detected by external magnetic sensors for tracking, while the AC resistance of the coil (voltage amplitude across the coil divided by current amplitude) is simultaneously measured. The coil electrical resistance increases linearly with temperature and thus comprises a thermometer.

[0079] In one preferred embodiment, NGS (Needle Guidance System) sensors are placed on the delivery device shaft and on the TRUS probe to determine the location and angular orientation of the delivery device shaft tip relative to the TRUS probe, enabling an animation of the delivery device shaft to be displayed on the TRUS image. An animation of cancerous tissue within the prostate, as determined from a pre-operative MRI image of the prostate, is also displayed on the TRUS image. An animation of the needle extending in its preferred arc from the delivery device is also shown. The preferred arc is the arc the needle takes in air or simulated prostate tissue, defined by an arc equation expressing the 3D location of the needle tip as a function of deployed length of the needle. The animated needle arc is displayed while the delivery device shaft is translated or rotated within the urethra (prior to needle deployment). When the needle tip vapor delivery holes intersect the cancerous tissue at a target location, the needle may be deployed, and vapor delivered. In this regard it is essential that the needle follow the arc equation on every deployment regardless of tissue inhomogeneities encountered by the needle tip. Mechanisms are presented in this invention to insure proper needle deployment including: means to extend the needle at right angles to the delivery device shaft; needle guides within the delivery device shaft that keep the needle in a single plane; means to strengthen the needle against bending out of plane while allowing it to take a preferred arc; means to increase the delivery force and needle velocity while reducing the size and weight of the delivery device cartridge.

[0080] In one preferred embodiment, a flexible rod or shape memory tube may be inserted through the delivery device needle and moved forward to protrude through the needle tip, thus converting a dull tip that cannot penetrate the prostate capsule to a sharp tip that may readily penetrate a urethra wall or dense tissues encountered in the prostate. As a tube, a biocompatible glue may be delivered through the tube to the needle puncture site at the time of retraction from the urethra to seal the puncture hole, preventing vapor leakage when therapy is delivered to an adjacent site, and preventing post-therapy bleeding from the puncture site.

[0081] One overriding concern for a medical therapy is the cost of goods sold (COGS), and especially the cost of goods that must be disposed of at the end of the procedure. One example of COGS reduction in this invention is moving the needle motion controller (which may be, for example, a solenoid) from the disposable cartridge to a linear motor disposed in the reused system console. This move reduces the size of the delivery device cartridge, thus preventing mechanical interference with the TRUS probe. In another embodiment of this invention, a mechanism is disclosed to combine a standard delivery device having vapor delivery holes spaced behind the delivery device needle tip, a Retreatment Needle (RTx) and a PZ (Peripheral Zone) needle having all vapor delivery holes closer to the distal end of the needle. The PZ needle may be configured to facilitate vapor delivery to the PZ, which may be relatively thin, without crossing into adjacent zones of the prostate. The compound device of this invention comprises the hole patterns of both devices and covers selected holes to go between standard and PZ vapor patterns. In addition, a rod passing through the vapor lumen of the delivery device needle may be extended to convert the dulled needle of a Standard needle to the sharpened tip of a retreatment needle.Vapor Delivery System

[0082] FIG. 1 shows an embodiment of a vapor delivery system 100.

[0083] Shown here is a vapor delivery device 104 having a shaft that is inserted into the patient’s urethra to the level of the prostate and a vapor delivery needle configured to deliver vapor into the prostate; a TRUS probe 106 that is inserted into the patient’s rectum to the level of the prostate to provide real time ultrasound images of the prostate throughout the procedure; stabilizers 108 that lock the TRUS probe 106 and vapor delivery device 104 into adjustable locations relative to the patient; a hand-held therapy remote controller 114; a system console 102 containing mechanical and electronic elements; and a monitor 116 that displays: TRUS images; pre-operative MRI images; animations of the delivery device shaft and needle and locations of cancerous and treated tissue; and patient and system dataincluding the deployed length of the needle (which may correspond to a measured travel of the solenoid magnet) and the impedance magnitude and phase of tissues adjacent the needle tip bio-impedance electrodes. The functions of each system element shown in FIG. 1 are discussed above, while the inventive elements are further described below.Repeatable Needle Arc

[0084] FIG. 2 shows a distal portion of a vapor delivery device 200 having a repeatable arc of a vapor delivery needle as it exits the delivery device shaft 204.

[0085] In one example, the delivery device needle forms the arc shown in FIG. 2 as it exits the shaft into prostate tissue. The z axis of the needle arc is expressed mathematically by the equation: z = 0.0006r3+ 0.00321^ - 0.3497r + 7.2985, where r is the radial separation of the needle tip from the z axis in the plane of the arc. The needle deployed length, s, is expressed mathematically by the equation: s = 0.008r2+ 0.8001r - 2.3181. In clinical use, an animation of the needle is superimposed onto the real time TRUS image at the current location of the shaft in the urethra. An animation of the cancerous tissue is taken from the patient’s pre-operative MRI and is also superimposed on the real time TRUS image. Using the arc equations, the needle animation may be rotated and translated (while the actual needle is retracted to its home position) by rotating and translating the delivery device shaft within the urethra. The shaft location, needle deployed length, s, and shaft rotation angle may be adjusted until the animated needle vapor delivery holes appear to be in the centroid of the animated cancer (or at another preferred location). The needle is then deployed until the measured deployed length is equal to the length computed from the arc equations at the target needle location, and vapor is delivered. Vapor is visible on the TRUS images, so the treated volume may be recorded and shown as an animation on the TRUS image for reference. This treatment method relies upon the accuracy of the needle arc equations, and most especially upon the repeatability of the needle following the arc equations every time it is delivered or retracted from the shaft.

[0086] Also shown is vapor delivery shaft 204, needle deployed length marks 206, and needle tip transmitter / sensor 214, needle tip 212, and NGS sensor 215.

[0087] This disclosure provides systems and methods to ensure a repeatable needle arc.

[0088] FIGS. 3A-3D show an exemplary mechanism for advancing a vapor delivery needle 300 into tissue in a single plane and in a repeatable arc. FIGS. 3A-3D also show cross-sectional views of the needle having a distal portion 302 and a proximal portion 304. In these examples, the needle can be slideably disposed within or adjacent to a needle guide 302A / 304A. For example, in some embodiments the needle guide can comprise a lumenwithin which the needle is advanced and retracted. In other embodiments, the needle guide can include features such as protrusions, guides, ridges, cutouts, or other engagement features configured to engage with or interact with the needle. The needle guide can be disposed within the shaft and configured to engage with the needle. In some aspects, the needle guide is disposed along some or all of the needle. For example, the needle guide can be disposed along the entire needle, along only the distal portion, or along only the proximal portion. In some embodiments, the needle guide can be intermittently spaced along the length of the needle. The needle can include corresponding features to engage with the needle guide. In some embodiments, the needle guide near the distal portion of the needle can be different than the needle guide near the proximal portion of the needle. FIGS. 3 A-3D show cross sectional views along the length of the needle corresponding to the cross section of the needle / needle guide at that location, to give a sense for where the needle guide features are located along the axial length of the needle.

[0089] As shown in FIGS. 3A-3D, the needle is prevented from rotating about its axis or deflecting out of the plane of its arc by adding features to the needle and to the needle guide within the shaft that prevent the needle from rotating relative to the shaft.

[0090] FIG. 3A shows an embodiment wherein a protrusion 303 that can include, for example, a rod or micro-tube, runs along some portion of the length of the needle 300 and engages a needle guide that runs along some portion of the delivery device shaft to resist torques on the needle and to keep the needle in the plane of the shaft as it advances through and out of the shaft. In FIG. 3A, the proximal needle guide 304A comprises a circular crosssection lumen that surrounds proximal portion 304 of the needle. However, the distal needle guide 302 A includes a tube, protrusion, or secondary lumen that accommodates a protrusion 303 of the needle to prevent rotation of the needle. The needle guide may be disposed within the shaft and shaft tip or simply at the needle exit point. The needle guide may comprise a needle rod or tube that may be an extruded feature of the needle (all one material such as PEEK) and may extend along a distal portion of the needle, or along the entire length of the needle. If the feature is a tube, electrical wires may extend through the tube to needle tip sensors. Alternatively, a fluid may be injected through a lumen of the needle protrusion 303 or of the needle guide to enhance therapy or to adhesively seal the needle puncture site upon retraction.

[0091] FIG. 3B shows an embodiment of needle 300 in which the distal needle guide 302 A are positioned on opposing sides of the protrusion 303 of the needle to keep the needle in-plane as it exits the distal end of the delivery device shaft. While the needle guides areshown as only being located in the distal portion of the needle, it should be understood these could be placed along the distal portion, the proximal portion, or along all or substantially all of the length of the needle.

[0092] FIG. 3C shows an embodiment with protrusions 303 on two opposing sides of the needle, with corresponding needle guide features to keep the needle in plane. Similar to the embodiment of FIG. 3 A, the protrusions 303 can comprise a rod or micro-tube running along some or all of a length of the needle 300. In this example, the protrusions are disposed along a proximal portion 304 of the needle.

[0093] FIG. 3D shows an embodiment in which the vapor delivery needle includes a noncircular cross-section 306 to prevent rotation along some or all portions of the needle shaft. The needle guide cross-section can conform to or surround 306 A the non-circular crosssection, or alternatively, can be sized and shaped so as to not constrain 306B the needle. In some examples, the needle can transition (e.g., towards the proximal portion) towards a circular cross section 306C. Also shown are embodiments in which the vapor delivery needle is divided into two or more lumens 306D to prevent rotation. These designs may enable needle arcs that are closer to 90° than a round needle. For example, a flat tape measure can readily bend in a 90° arc, which may be more repeatable than other curved arcs (e.g. FIG. 2). Other embodiments are shown in which vapor flow resistance may increase in multiple (e.g. triple) lumens 308 or elliptical lumens 310 since resistance is proportional to 1 / A2where A is the cross-sectional area of the lumen. For example, one lumen has 1 / 8 the flow resistance of two circular lumens each having half the diameter. An increase in flow resistance in the distal end of the needle may be compensated by slightly increasing the inside diameter 312B of the longer proximal length of tubing relative to the diameter 312A of the distal length of tubing as shown in FIG. 3D.

[0094] FIG. 4 shows a delivery device 400 with an enlarged shaft tip 403 relative to the rest of the device shaft 405. The enlarged tip 403 provides a larger radius of curvature for the needle as it transitions from the elongate delivery configuration to the transverse deployed configuration, thereby providing longer needle path through the width of the tip that allows more needle curvature, which in certain examples may be preferably to an angle of 90°. A 90° arc may be preferred because needle deployment forces are then directed along the length of the needle 401 within tissue, with no force component parallel to the shaft and parallel to tissue planes, such as the wall of the urethra, that may deflect the needle 401. An enlarged shaft tip 403 can navigate to sites along the prostatic urethra provided that the rest of the shaft 405 is rigid and not enlarged, and providing that the taper between the tip and proximal shaftis slight to prevent hang up on obstructive features in the urethra. The enlarged tip may provide better back up for needle deployment and more of a seal against vapor blow-back around the needle puncture hole.

[0095] FIG. 5A shows a vapor delivery device 500 that includes a pull-wire mechanism configured to deflect the delivery device shaft tip to produce a desired needle arc.

[0096] FIG. 5A shows an embodiment in which pull wires 530 embedded in the walls of a flexible shaft 503 A can be activated to create a desired needle path, and preferably needle deployment at right angles 501 A to the urethra 520. The pull wires can be attached or anchored near a distal end of the shaft, for example. Also shown is a vapor seal elastic balloon 525 disposed in the flexible shaft 503 A that may be inflated before vapor delivery to prevent vapor blow-back around the needle puncture hole. The balloon 525 may surround the distal end of the tip where the vapor needle exits from the shaft.

[0097] In some embodiments, the pull-wires can be configured to deflect or steer a distal end of the shaft tip. In other embodiments, the pull-wires can be placed such that they form a deflection or curvature in the device shaft tip that is slightly proximal of the tip. For example, referring to FIG. 5 A, the device shaft tip can be manipulated, deflected, or curved such that deflection portion 504, positioned proximally of the tip portion 506, deflects or curves outwardly from the longitudinal axis of the shaft. In some aspects, this can cause distension or expansion of the tissue lumen, such as the urethra, as shown. This provides for a longer radius of curvature of the needle through this deflection portion to where the needle exits the tip at tip portion 506.

[0098] FIG. 5B is a cross-sectional view of a vapor delivery device 500 that shows a pullwire mechanism configured to deflect the vapor delivery needle along a bending axis.

[0099] In FIG. 5B, pull wires 530 are embedded in the wall of the vapor delivery needle to bend the needle about the bending axis shown and help deflect it at right angles to the shaft during deployment. The pull wires can be disposed, for example, in lumens within the needle itself (e.g., on opposing sides of the needle). The vapor lumen area is maximized in FIG. 5B by extending it between four lumens, towards the periphery of the needle, two lumens containing the pull wires and two lumens containing leads 531 that run to bio-cap electrodes exposed on the tip of the needle.

[0100] FIGS. 6A-6B shows an embodiment of a vapor delivery device 600 where an adjustable needle guide 640A within the delivery device shaft tip 643 A is steerable to allow selectable needle arcs 641A-641B.

[0101] In some embodiments it is desired to have the needle 640 advance forward, toward the shaft tip 643 A as shown. For example, in some patients the urethra ends at the bladder neck while prostate tissue can extend past the bladder neck, especially in anterior prostate tissue. An adjustable needle guide 640A may be employed using pull wires 640B that are activated by mechanical forces, electromotive forces, heat-shape materials, etc. The adjustable needle guide can be configured to adjust a deployment angle or arc of the needle. In some aspects, the adjustable needle guide is controllable to adjust or change a position or orientation of the adjustable needle guide within the device shaft. For example, pull wires attached or coupled to the adjustable needle guide may be configured to adjust or change the angle, orientation, or position of the needle guide relative to the shaft, thereby changing or controlling the deployment angle or arc of the vapor delivery needle. In some aspects, the distal end of the shaft may be enlarged relative to the rest of the shaft, as described above, to provide additional space for the needle to curve or deflect as it is deployed. The device of FIGS. 6A-6B may also include the inflatable balloon of FIGS. 5A-5B to prevent vapor blowback during vapor delivery.

[0102] FIG. 7 shows a vapor delivery device 700 having a vapor needle 740, or distal portion of a needle, that is made from a super-elastic or shape memory metal such as nitinol that has been partially cut in parallel slices or slots 742 perpendicular to the needle.

[0103] The slices allow the needle to bend in the plane of the page in FIG. 7 while resisting bending in other planes, as well as allowing the needle to recover back to a straightened position after bending. Depending upon the width and number of the slices the needle may be made to bend in a preferred 90° arc. Other slice patterns may be considered to optimize needle performance. The slices may be cut into nitinol tubing 744 using a laser or stent technology, and the slice width may be in the range of 0.003” to 0.005” with the slices separated by 0.012” to 0.020”. A polymer coating over the sliced tube prevents leaks and thermally insulates the needle. Material selection and material processing may determine the arc shape and repeatability.

[0104] FIG. 8 shows a vapor delivery device 800 including a needle comprised of a shape memory alloy 806 that can be heat formed into selected arcs while being a rigid metal 800.

[0105] The proximal needle has a vacuum insulation 804. The needle comprises a vapor delivery lumen 802 and has vapor delivery holes 802A that direct vapor into target tissue. An example needle may be made from PEEK tubing having an inside diameter of 0.033” and an outside diameter of 0.053”. The needle passes through a thermally insulating tube 801 within the delivery device shaft to prevent condensation of steam within the needle. In theembodiment of FIG. 8 the straight section of the needle is made from inner and outer tubes 806 and 808 that are separated from each other by a vacuum insulation to prevent heat transfer from the vapor lumen of the needle. The inner tube extends to the needle tip and is made from a shape memory material such as nitinol. The distal end of the inner nitinol tube is covered by a polymer tube, for example PEEK, that may taper from the o.d. of the proximal nitinol tube to the needle tip. The taper may provide a seal against vapor blow-back around the needle (due to tissue elasticity).

[0106] FIGS. 9-10 illustrate an apparatus to prevent vapor leaks around the vapor delivery needle and / or to support the needle during its travel and during therapy delivery.

[0107] FIG. 9 shows a vapor delivery device 900 that includes a tapered sheath 902B around the vapor delivery needle 940 as it extends from delivery device shaft 905, where the taper starts at 902 and ends at 902A. In one embodiment, the tapered portion is fixed onto the needle and prevents vapor blow-back around the needle 940. In a second embodiment shown in FIG. 9, the sheath 902B is movable independently from the needle 900. The sheath 902B may extend over the distal portion of the needle 940 with a pull wire or other means used to push and pull the sheath 902B. The sheath may be constructed from a material that adds structural support to the needle 940, for example using a shape memory metal. The sheath 902B may extend over most of the needle length, exposing a length needed for needle movement independent of the sheath 902B. The sheath 902B and needle 940 may be moved independently by two linear motors located in the system console as seen in FIG. 12. The sheath 902B may add enough stiffness to the needle 940 that it advances in a repeatable arc. The sheath 902B may seal against vapor blow-back around the needle puncture site.

[0108] FIG. 10 shows another embodiment of a vapor delivery device 1000 having improved support for the needle 1040 and shaft tip with inflated balloon 1025 A and inflation fluid 1025B surrounding a distal portion or tip of the delivery device shaft 1005. In some examples, the balloon 1025 A surrounds the needle tip asymmetrically with more of the inflated balloon 1025 A volume above (opposite the needle exit) than below, thereby forcing the needle tip in the direction of the needle exit. The balloon 1025 A may be made from an elastomeric material that expands to some degree to fill up the cross-sectional area of the urethra 1005 adjacent to the balloon 1025A. This back-up support may enable a more stable and repeatable needle arc. When the balloon 1025 A is inflated, a part of the elastomeric balloon may seal 1025 around the needle 1040 to prevent vapor blow-back from the needle puncture hole during therapy.Improved Needle Control

[0109] In some embodiments, the maximum needle extension from the shaft may be approximately 24 mm, while up to 30-35 mm extension may also be preferred. In some cases, the needle encounters tissue that cannot be penetrated with shorter needle extensions, especially when the needle is near its maximum extension where solenoid force of the driving system is reduced. A system may be needed in which the needle push force is increased and is maintained over the entire range of needle extension from the shaft tip. In some cases, a needle jackhammer mode is desired to penetrate dense or even calcified tissues. The needle momentum can be used for penetration by pulling the needle back several mm from a blockage, then firing it forward at full force. Densified tissue has been encountered at the needle entry site of the urethra, especially in re-treatment cases. A larger needle force or increased needle momentum is desired to penetrate the urethra in all cases. A linear needle driver is desired having more force, higher velocity (or momentum), and longer stroke than the present system. Conflicting requirements for a needle driver located in the cartridge are: reduced cartridge dimensions to eliminate mechanical interference with the TRUS probe; and reduced cost of disposable goods.

[0110] FIGS. 11-13 illustrate vapor delivery devices having mechanisms to control needle movement from a linear motor or hydraulic cylinder located in the system console, while reducing the size and weight of the delivery device cartridge and minimizing disposable system components.

[0111] A vapor delivery system 1100 having a needle driver that meets the above requirements is shown in FIG. 11. Most significantly, the linear motor 1172 has been moved from the delivery device cartridge 1176 to the system console remote or proximal from the cartridge. Forces generated at the motor 1172 are transferred to the needle 1140 located in the delivery device cartridge 1176 by an incompressible cable. The cable may comprise, for example, a long (e.g., 5-10 feet long) lubricious Teflon coated super-elastic nitinol core wire 1174A that moves within an incompressible tube that has a bend radius of six inches or less. The cable tube may be comprised of two layers of braided wire, braided in opposite directions. As shown in FIG. 11, the cable is medical grade and disposable 110 IB, although the cable could be reusable 1101 A, for example by using a sterile barrier means such as shown in FIG. 12. The cable connects to the generator through a quick-connect 1174B or another mechanical connector. In one embodiment of FIG. 11, the cable core wire 1174 A pushes and pulls on a needle carriage 1180 that deploys and retracts the needle 1140. The “slop” in the core wire 1174A should be less than 0.5 mm as the needle 1140 is advanced or retracted. This can be reduced further by compensating the linear motor movement by ameasured amount of slop, or by measuring the location of the needle 1140 and feeding it back to the linear motor 1172 which then moves the needle to a desired location.

[0112] The solenoid needle driver within the present delivery device cartridge is replaced in FIG. 11 by a small needle carriage 1180 attached to the core wire. The delivery device cartridge 1176 in FIG. 11 can be less than one inch diameter, compared to more than 2 inches for the solenoid assembly in the present cartridge design. Needle movement may be enabled by forming the proximal end of the needle 1140 into a flexible needle extender coil 1176B attached to the heating element 1176A. The heating element coil 1176B can comprise an “Inconel 625” coiled tube with outside diameter less than 0.5 inches. The cost and size of the cartridge 1176 shown in FIG. 11 are greatly reduced compared to present designs.

[0113] Linear motors are available having dimensions small enough to fit into the system console of FIG. 1 and developing 10’s of pounds of linear force and speeds up to 7 m / sec (compared to 1-2 m / sec for the present solenoid system). Strokes exceed the new system requirement of 30-35 mm. The measured location of the motor drive shaft is accurate to 0.05 mm and is held in place with more than one pound of force. The motor may be programmed for arbitrary linear movements, such as continuous or step pulse modes or jackhammer mode, etc. These motors will multiply the needle force and speed needed to penetrate densified tissues encountered in the urethra and prostate.

[0114] FIG. 12 is an embodiment of FIG. 11 in which the mechanical cable of the vapor delivery system 1200 is replaced by hydraulic fluid lines 1285 that drive a piston connected to the delivery device needle 1240.

[0115] The hydraulic driver is in the system console and may be a push-pull solenoid, a linear motor, or other fluid driver 1200M. The fluid system is sealed and reusable, being connected to the delivery device cartridge 1276 by a sterile coupler 1281. A sterile sheath 1283 comes with the coupler and rolls down the hydraulic lines to a point that is out of the sterile field of the patient. The position of the needle 1240 is sensed and fed back to the hydraulic driver for sub-mm needle placement accuracy. Also shown are DC power supply 1200P and electronic switch 1200E, CPU 1200C, position feedback 1200F which may be coupled to needle position sensor 1240P, hydraulic fluid 1285, clamps 1282 at a sterile coupler 1281 interfacing with a seal 1284 and sterile roll-on sheath 1283. Sterile coupler may further be coupled to cartridge 1276 having heating element 1276A and needle extender coil 1276B via water line 1278. Sterile water is injected through water line 1278 into heating element 1276A where it is converted to steam and passed through needle 1240 into prostate tissue. Needle extender coil 1276B may be coupled to needle cartridge 1276B of needle1240. Controlled movements of piston 1200P are hydraulically coupled to movements of piston 1250P that are coupled via sterile coupler 1281 to controlled movements of needle 1240.

[0116] FIG. 13 shows one preferred embodiment of a vapor delivery device 1300 in which the tapered sheath of FIG. 9 is controlled independently of the vapor delivery needle.

[0117] The tapered sheath 1302B may be deployed following needle deployment to a depth that seals around the needle 1440 to prevent vapor blow-back. The sheath 1302B may be deployed along with the needle 1340 to provide extra support to the needle 1340. The needle 1340 may be advanced first with the sheath 1302B then advanced separately over the needle 1340. The sheath 1302B, constructed from a shape memory material, may be deployed first to guide the needle 1340 deployment into a preferred arc. The needle 1340 and sheath 1302B are advanced by two linear motors located in the system console, with cables 1340CM / 1340SM extending to carriages 1380 / 1380S within the cartridge 1376 as shown. Also shown is water line 1378, which may be coupled to heating coil 13769A, as well as needle stretch coil 1376B.

[0118] FIGS. 14A-14C show views of a vapor delivery device 1400 that includes vapor delivery device cartridge.

[0119] A more detailed preferred embodiment of a vapor delivery device is shown in FIGS. 14A-14C. In the side view 1400 of FIG. 14A and front and back views of FIG. 14B- 14C, the needle driver wire 1440W and sheath 1440S are seen extending from the delivery device cartridge 1476 back to the system console (not shown). The needle is attached to the needle driver carriage 1480 which moves laterally within the cartridge frame 1476F. The proximal end of the needle is attached to a flexible vapor outlet tube 1406VO that is turned back on itself so it can shorten or lengthen when the needle moves forward or backward. The flexible tube is attached to the heating element 1476A. Also shown are the saline water flush tube 14041 that extends through the cartridge 1476 and through the delivery device shaft 1405 to the shaft tip where it both cools the shaft and cleans debris from the cystoscope camera lens. Drain water flows through a drain tube 14060 beside and behind the flush tube in the figure. The drain tube 14060 removes flush fluid and may be connected to vacuum when flush is ON. Otherwise, urine may drain through this tube. Proximal 1402 and distal 1404 cartridge end caps are shown in the figure.

[0120] FIGS. 14B-14C are cut-away views of the cartridge showing the heating element and the outlet vapor path through the flexible outlet tube and into the needle 1440. The heating element 1476A in this embodiment is a flat coil with its axis perpendicular to the axisof the cartridge. This contrasts with prior heating elements that are circular and are concentric with the cartridge axis. The heating element 1476A comprises a metal tube covered by a thin thermally and electrically insulating layer with melting temperature above about 200° C, for example a polyimide tube. In one embodiment, Ohmic heat is generated in the tube by electrical current flowing through the tube wall. The needle 1440 is rigidly attached to the needle carriage 1480 which is pushed and pulled by the needle driver wire 1440W. In this embodiment the sides of carriage 1480 are flat to prevent rotation of the needle and enable a repeatable needle arc of the needle into tissue. Flush path 1404P and drain water path 1406P are shown in a view of FIG. 14C, where the paths comprise longitudinal channels through the delivery device shaft which may at least partially house vapor needle 1440. Also shown is flush water inlet tube 1404T, drain water outlet tube 1046T, and drain / flush water manifold 1406M.

[0121] FIGS. 15A-15B show views of a vapor delivery device 1500 including embodiments of a distal shaft and needle.

[0122] FIG. 15A shows a side view of a distal section of delivery device shaft 1505. The shaft has a coude’ (bent) tip 1503 that helps navigate the shaft 1505 through features of the urethra. The needle in this embodiment exits the shaft, 1505, at a right (90° angle) 1540P which enables a repeatable arc. The digital camera 1507 is shown pointed down to view the needle as it deploys into tissue.

[0123] FIG. 15B shows conduits through delivery device sheath 1540S for the needle conduit 1540C, flush 1504C, and drain 1506C, fluids, and electrical leads, 1510C, for the camera 1507 and sensors. The needle sheath 1540S may comprise a multi-lumen plastic extrusion, for example a PEEK extrusion. In certain examples, the sheath 1540S may have a coude’ tip 1503 and the needle conduit 1540C may have a 90° needle path 1540P.

[0124] FIG. 16 illustrates a mechanism for controlling the sharpness of a delivery device needle tip 1600, which may also be configured to serve as a fluid injection port and a platform for bio-impedance electrodes.

[0125] In some embodiments it is desirable to provide a mechanism that converts a blunt needle tip (used to prevent penetration of the prostate capsule) to a sharp tip that can readily penetrate dense tissue within the prostate or wall of the urethra without a costly exchange to a new delivery device. As shown in FIG. 16, a vapor delivery device 1600 having a mechanism by which a sharpened rod may be pushed from the needle tip to facilitate penetration. The rod may be advanced by a needle liner, or the rod may itself pass through the needle 1640 to the delivery device cartridge. In either case, the rod and needle 1640 may be advanced byseparate linear motors and / or solenoids located in the system console or cartridge as shown in FIG. 13. The liner push / pull mechanism 1602 and / or rod push / pull mechanism 1604 may reduce the vapor flow cross sectional area enough that the inside diameter of the needle needs to increase. Embodiments where the rod extends to the delivery device cartridge may facilitate passage of a gas or a fluid to tissue distal of the needle tip, for example via fluid delivery holes 1602 A. For example, a medical grade adhesive may be injected by extending the fluid injector rod 1606 shown in the figure to seal a needle puncture hole when the needle is retracted 1602 from the urethra to prevent bleeding or prevent vapor blow-back when vapor is delivered from an adjacent puncture site. In another embodiment, electrical leads extending to sensors adjacent to the needle tip may pass through a hollow rod and extend into the delivery device cartridge. One example sensor is bio-impedance electrodes 1602C.

[0126] Another cost savings is realized by being able to convert vapor delivery hole patterns within a single delivery device. An example system comprises three delivery devices, one with a standard array of vapor delivery holes (Standard device), one designed for thin peripheral zones in which all vapor delivery holes are closer to the needle tip (PZ device), and one designed for retreatment that has the PZ hole pattern and a sharpened needle tip. The inventive concept is to provide enough holes for both flow patterns and to block the flow of vapor through selected holes to create either the Standard or PZ hole patterns. One such embodiment is shown in FIG. 17.

[0127] FIG. 17 illustrates a vapor delivery device 1700 configured to deliver steam to selected locations along the delivery device needle.

[0128] As shown here, a movable liner 1701 on the needle distal inside diameter may be rotated and advanced or retracted and rotated degrees 1702 / 1704 to expose vapor holes 1709 for either a PZ 1703 or Standard 1705 hole pattern. The liner may include one or more windows 1707 to control the number of vapor holes that are exposed when the liner is moved in place over the holes. If a hollow rod is used to manipulate the hole pattern, a separate rod may be advanced through its inside diameter and through the needle tip to combine the variable hole pattern and extended needle tip concepts of FIGS. 16-17 to be used, for example, in retreatment procedures.

[0129] It may be appreciated that the mechanisms disclosed in this invention may be used to enable other clinical applications. FIG. 18 shows application of this invention to a transurethral tissue collection system 1800.

[0130] For example, FIG. 18 shows a transurethral tissue sampling (biopsy) device 1800 that employs the dual linear motor mechanism of FIG. 13 to separately control a tissuesample collector core 1842 and a concentric cutting needle 1806. Inside the prostate, the sample collector 1842 may be advanced distal of the needle 1806 (or the needle retracted proximal of the sample collector trough) to expose and collect suspect tissue within the trough after which the needle 1806 is rapidly advanced to slice off the tissue sample. The needle 1806 and sample collector 1842 may be retracted together into the delivery device shaft after which the sample collector 1842 may be removed separately or together with the needle 1806. A cover 1884 over the cartridge 1876 may be closed during device delivery and sample collection.

[0131] In some embodiments, the needle 1806 and sample collector 1842 may be connected via flexible cables 1885 to linear motor drivers located in the system console. A proximal portion 1807 of the needle 1806 is removably connected to a needle carriage 1878 with a removable needle attachment, and a shaft 1841 of the sample collector 1842 is removably connected to a sample collector carriage 1880, such as with a clamp 1882 or other attachment means. Needle position sensor 1833a and sample collector position sensor 1883b can track the relative positions or deployment distances of the needle and sample collector, respectively. A cover 1884 may be closed over the delivery device cartridge 1876 when it is in use. Flexible drive shafts can be attached to linear motors 1885.

[0132] Although embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. Variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.

Claims

CLAIMSWhat is claimed is:

1. A vapor delivery system, comprising: a shaft configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced generally transverse to the shaft, wherein the needle has exit ports at a distal end configured for vapor delivery to the prostate; a vapor source fluidly coupled to the needle; and a needle guide disposed within the shaft and configured to engage with the needle to prevent the needle from rotating relative to the shaft.

2. The system of claim 1, wherein the needle comprises a protrusion extending along at least a portion of the needle, wherein the protrusion is configured to engage with the needle guide.

3. The system of claim 2, wherein the protrusion comprises rod or microtube.

4. The system of claim 2, wherein the protrusion is disposed along only a portion of the needle.

5. The system of claim 2, wherein the protrusion is disposed along only a proximal portion of the needle and not along a distal portion of the needle.

6. The system of claim 2, wherein the protrusion is disposed along only a distal portion of the needle and not along a proximal portion of the needle.

7. The system of claim 2, wherein the needle guide comprises a plurality of needle guides disposed along opposing sides of the protrusion to stabilize the needle.

8. The system of claim 2, wherein the needle guide comprises a lumen within the shaft sized and shaped to conform to the needle and the protrusion.

9. The system of claim 1, wherein the needle comprises a plurality of protrusions extending along at least a portion of the needle, wherein the plurality of protrusions are configured to engage with the needle guide.

10. The system of claim 9, wherein the plurality of protrusions comprise rods or microtubes.

11. The system of claim 9, wherein the plurality of protrusions are disposed on opposing sides of the needle.

12. The system of claim 9, wherein the plurality of protrusions are disposed along only a portion of the needle.

13. The system of claim 9, wherein the plurality of protrusions are disposed along only a proximal portion of the needle and not along a distal portion of the needle.

14. The system of claim 9, wherein the plurality of protrusions are disposed along only a distal portion of the needle and not along a proximal portion of the needle.

15. The system of claim 9, wherein the needle guide comprises a plurality of needle guides disposed along opposing sides of the plurality of protrusions to stabilize the needle.

16. The system of claim 9, wherein the needle guide comprises a lumen within the shaft sized and shaped to conform to the needle and the plurality of protrusions.

17. The system of claim 1, wherein the needle has a non-circular cross-section, and wherein the needle guide comprises a lumen sized and shaped to conform to the needle.

18. The system of claim 17, wherein the needle is oval-shaped.

19. The system of claims 2 or 9, wherein the protrusion or plurality of protrusions further include a lumen disposed therein.

20. The system of claim 1, wherein a distal tip of the shaft has an expanded diameter relative to the rest of the shaft.

21. A vapor delivery system, comprising: a shaft configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced generally transverse to the shaft, wherein the needle has exit ports at a distal end configured for vapor delivery to the prostate; a vapor source fluidly coupled to the needle; and pull wires attached to a distal portion of the shaft and configured to impart deflection or curvature in the distal portion of the shaft to adjust an arc of the needle when it transitions from the delivery configuration to the deployed configuration.

22. The system of claim 21, wherein the pull wires are configured to impart deflection or curvature in the distal portion of the shaft, proximal to a distal tip of the shaft.

23. The system of claim 21, wherein the deflection or curvature provides an increased radius of curvature for the needle in the deployed configuration.

24. The system of claim 21, further comprising an inflatable balloon at least partially surrounding an exit port of the needle on the distal portion of the shaft.

25. The system of claim 24, wherein the inflatable balloon is configured to prevent vapor blow-back around the needle.

26. The system of claim 21, wherein the needle comprises a vapor lumen and a pair of pull wire lumens, wherein the vapor lumen is configured to extend at least partially past the pair of pull wire lumens towards a periphery of the needle to increase a volume of the vapor lumen.

27. The system of claim 21, wherein the needle comprises a vapor lumen, a pair of auxiliary lumens, and a pair of pull wire lumens, wherein the vapor lumen is configured toextend at least partially past the pair of auxiliary lumens and the pair of pull wire lumens towards a periphery of the needle to increase a volume of the vapor lumen.

28. The system of claim 27, wherein the pair of auxiliary lumens are configured to accommodate electrical leads.

29. A vapor delivery system, comprising: a shaft having a tip configured for transurethral access to a prostate of a patient; a needle disposed in the shaft, the needle having a delivery configuration in which it is fully positioned in the shaft and a deployed configuration in which it is advanced radially outwards from the shaft an adjustable needle guide engaged with the needle and configured to change a deployment angle of the needle; and a vapor source coupled to the needle.

30. The system of claim 29, wherein the adjustable needle guide is coupled to pull wires configured to change a position and / or orientation of the adjustable needle guide.

31. The system of claim 30, wherein the preferred arc is at a substantially 90 degree angle to a urethra of the patient.

32. The system of claim 29, wherein pull wires coupled to needle guide elements near the tip of the shaft are adjusted to guide the needle on a preferred arc as the needle exits the shaft and moves into tissue.

33. The system of claim 32, wherein the preferred arc is at a substantially 90 degree angle to a urethra of the patient.

34. The system of claim 29, wherein the shaft tip is enlarged to provide a larger degree needle angle to a urethra of a patient, wherein the degree needle angle is substantially 90 degrees.

35. The system of claim 29, further comprising an inflatable vapor seal configured to be inflated before vapor delivery to prevent vapor blow-back around a puncture hole of the needle.

36. A needle driver system comprising: a motor; a delivery device cartridge comprising: a heating element, a needle extender means, and a needle carriage configured to receive a needle; a cable to transmit linear motion generated by the motor to the carriage; a needle having a tip to be received in a patient, wherein the linear motion generated by the motor is transmitted to the delivery device carriage to deploy and retract the needle; and a shaft configured for transurethral access to a patient, wherein the needle egresses through a portion of the shaft.

37. The system of claim 36, wherein the cable is incompressible, wherein the cable has a core wire having an adjustable amount of slop.

38. The system of claim 36, further comprising hydraulic fluid lines in place of the cable.

39. The system of claim 36, further comprising a tapered sheath over a distal portion of the needle, wherein the tapered sheath is deployed and advanced independent of the needle.

40. The system of claim 36, further comprising access or connections for one or more of: a needle driver wire and sheath, a flush water inlet, a sterile water inlet, a flexible vapor outlet tube, and a camera.

41. The system of claim 36, wherein the shaft has a bent coude’ tip configured for urethral navigation, wherein the needle exits the shaft at a substantially 90 degree angle to the shaft.

42. The system of claim 36, further comprising a sharpened rod configured to be advanced through a tip of the needle to facilitate tissue penetration, wherein the tip of the needle is retractable, wherein the rod facilitates passage of one or more of: (i) a gas, (ii) a fluid, or (iii) an adhesive out of the tip of the needle.

43. The system of claim 42, wherein electric leads coupled to sensors adjacent to the tip of the needle pass through the rod and into the delivery device cartridge, wherein the sensors are bio-impedance electrodes.

44. The system of claim 36, further comprising a movable liner on a distal portion of the needle, the moveable liner being configured to be rotated and / or axially to transition between a first vapor hole configuration and a second vapor hole configuration.

Images