Patent Description:
A number of medical conditions affect the male urethra causing a variety of symptoms including painful or difficult urination, a swollen prostate, blood in the urine, lower back pain, and the like. Some of these conditions, such as prostatitis, are bacterial infections which can be treated with antibiotics and other drugs. Other conditions, however, such as benign prostatic hyperplasia (BPH) and prostatic carcinoma, result in enlargement of the prostate and obstruction of the urethra, sometimes leading to complete loss of bladder function.

Both BPH and prostatic cancer require treatments which remove or shrink tissue in the prostate surrounding the urethra. Common treatments include transurethral resection of the prostate (TURP) where a resectoscope is placed in the urethra and used to remove excess prostatic tissue. Another procedure, referred to as transurethral incision of the prostate (TUIP), relies on cutting muscle adjacent to the prostate to relax the bladder opening to relieve difficulty in urination. More recently, a procedure referred to as transurethral needle ablation (TUNA) has been introduced where a needle is advanced through the urethra into the prostate and used to deliver energy, such as microwave, radiofrequency, or ultrasound energy, to reduce the size of the prostate, again relieving pressure on the urethra. Laser ablation using transurethral optical fibers also finds use.

While generally successful, none of these methods are adequate to treat all patients and all conditions. In particular, patients having severe tissue intrusion into the urethral lumen resulting from BPH or prostatic cancer are difficult to treat with minimally invasive protocols which rely on tissue shrinkage rather than resection. Thus, many of these patients will eventually require conventional surgical resection.

For these reasons, it would be desirable to provide minimally invasive methods and devices which provide for enlarging the luminal area and/or volumetric resection of tissue surrounding the urethra. It would be particularly desirable if such methods and devices provided for removal or destruction of such tissues surrounding the urethra where the removal or destruction products can be removed from the lumen to relieve pressure on the urethra, even where large volumes of tissue have been removed. Alternatively or additionally, the methods and devices should provide for anchoring of the treatment device relative to the urethra in order to provide a stable platform for treatment protocols which do not require visualization. Methods and devices for performing such protocols should present minimal risk to the patient, should be relatively easy to perform by the treating physician, and should allow for alleviation of symptoms with minimal complications even in patients with severe disease. At least some of these objectives will be met by the inventions described below.

Description of the Background Art. Use of a transurethral endoscope for bipolar radiofrequency prostate vaporization is described in <NPL>. Radiofrequency discharge in saline solutions to produce tissue-ablative plasmas is discussed in <NPL> and <NPL>. Air/water jets for resecting tissue are described in <NPL>. <CIT> described a needle injector on a catheter based system which can be anchored in a urethra by a balloon in the bladder. <CIT>; <CIT>; and <CIT> each describe catheters for producing an RF plasma for tissue ablation. Other patents and published applications of interest include: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

<CIT> discloses catheters with suction capability and related methods and systems for obtaining biosamples in vivo.

<CIT> discloses inflatable balloon catheter structural designs and methods for treating diseased tissue of a patient.

<CIT> discloses systems and methods for peri-urethral ablation.

<CIT> discloses devices and methods for adjustable trans-urethral radiofrequency ablation.

<CIT> discloses a high efficiency electrosurgical ablator with electrode subjected to oscillatory or other repetitive motion.

<CIT> discloses devices and methods for safely shrinking tissues surrounding a duct, hollow organ or body cavity.

<CIT> discloses ablation of rectal and other internal body structures.

<CIT> discloses a radial medical laser delivery device.

<CIT> discloses a surgical instrument and method.

Exemplary methods, devices and systems described herein for illustration purposes and not always falling under the scope of the appended claims provide for intraluminal delivery of energy, to ablate or resect tissue surrounding a urethra. Methods do not form part of the claimed invention. Examples are particularly intended for treating benign prostatic hyperplasia (BPH) and prostatic carcinoma, both of which can result in compression and partial or total occlusion of the urethra. Treatments comprise positioning an energy source within the urethra and directing energy radially outwardly from the energy source toward the urethral wall within the prostate. The energy source will usually be moved relative to the urethra to remove a pre-defined volume of prostate tissue surrounding the urethral lumen in order to partially or fully relieve the compression and/or obstruction. therapy may comprise mechanical, thermal, acoustic or vibrational, cryotherapy or other forms of treatment for BPH and other conditions. treatments may be combined with chemotherapy and other forms of drug delivery, as well as treatment with external X-ray and other radiation sources and administration of radiopharmaceuticals comprising therapeutic radioisotopes. For example, one or more drugs may be combined with the saline or other fluid which is used for energy delivery. The combination liquid/gas delivery can be used to both resect tissue and wash the tissue away while leaving intraprostatic blood vessels, capsule, and sphincter muscle undamaged. Thus, benefits of the high pressure liquid/gas energy source include limited bleeding with reduced or no need for cauterization and decreased risk of perforating or otherwise damaging the capsule of sphincter muscles. Alternatively, the device which is used to position the energy source can be utilized to separately deliver a desired chemotherapeutic or other drug (as just set forth), either before, during, or after energy treatment. While examples are specifically directed at transurethral treatment of the prostate, they may also find use in the treatment of other body lumens, organs, passages, tissues, and the like, such as the ureter, colon, esophagus, lung passages, bone marrow, and blood vessels.

Such exemplary methods for resecting and removing prostate tissue comprise positioning an energy source within the urethra and directing energy radially outwardly from the energy source toward a wall of the urethra within the prostate. The energy source is then moved relative to the urethra to remove a pre-defined volume of tissue surrounding the lumen. Such exemplary methods may further comprise expanding an anchor within the bladder at the distal end of the urethra. The energy source is then positioned and moved relative to the anchor to assure that the treatment is properly directed to prostatic tissue. The use of the anchor is particularly advantageous since it allows the procedures to be performed without endoscopic, fluoroscopic, or other imaging. Such exemplary methods , of course, do not exclude such imaging, but rather permit the methods to be performed when desired without further imaging.

Usually, the energy source and the anchor will be mounted on a common catheter assembly, more typically on a single shaft. Thus, the catheter assembly or shaft may be maintained in a fixed or immobilized position within the urethra by either applying a tension which engages the anchor against the bladder wall, or preferably by expanding the anchor fully within the bladder to reduce the risk that the catheter assembly or shaft can be accidentally dislodged.

The energy source can be any one or a combination of various conventional energy sources which can be used to resect or ablate tissues. A first exemplary energy source comprises high pressure fluids, such as water, saline, liquid therapeutic agent, or the like. The high pressure fluid is often a combination of a liquid and gas, such as water and air, and can be delivered radially outwardly in one or more fluid streams which impinge directly against the urethral wall and prostatic tissue to resect or debulk the tissue. The fluid stream(s) may be directed at a generally perpendicular or normal angle relative to a catheter assembly or shaft, and may also be directed at other angle(s), typically in the range from <NUM>° to <NUM>°, more typically from <NUM>° to <NUM>°, relative to the shaft or catheter assembly which carries the port or ejector used to deliver the fluid(s) including, for example, anesthetics, antibiotics, anti-inflammatories, anti-neoplastics, tissue-specific growth factors, anti-growth factors, hormones, anti-hormones, vasodilators, vitamins, proteins, and the like.

The energy source may also deliver laser energy used to ablate tissue. The laser energy will usually be delivered by an optical waveguide or fiber bundle carried within a catheter assembly or shaft which is introduced through the urethra. The laser energy can then be directed radially outwardly either by deflecting the shaft and/or by using a mirror to reflect the energy. The mirror may optionally have a surface which focuses or defocuses the energy in a desired manner as it is delivered to the prostatic tissue.

A third suitable energy source comprises an electrically conductive fluid which carries radiofrequency current, optionally generating a plasma of the conductive fluid. One or more streams of such electrically conductive fluids may be directed outwardly through ceramic nozzles or other distribution elements.

A fourth energy source comprises an electrode adapted to deliver radiofrequency energy. The electrode will have a deflected or deflectable distal end which can be directed radially outwardly from a catheter assembly or shaft which carries the electrode into the urethra. The tip or other surface of the electrode can thus be engaged against the urethral wall and prostatic tissue in order to deliver ablative radiofrequency energy into the tissue.

Exemplary methods may further comprise associated steps and processes to assist in the tissue resection and ablation. In order to gain a working space within the urethra, the methods may further comprise introducing a pressurized gas to expand (insufflate) the urethra lumen prior to or while directing the energy radially outwardly into the prostatic tissue. Further optionally, the ablation or resection products may be aspirated from the urethra, typically through a lumen in the catheter assembly or shaft used to deliver the energy source. In combination with aspiration, the urethra may also be flushed with saline or other fluid to assist in removing the ablation or resection products. Usually, both flushing and aspiration will be performed using lumens in the same catheter assembly or shaft which has been used to position the energy source.

The energy source will be moved in a pre-defined manner relative to the anchored shaft or urethra in order to selectively treat the prostatic tissue. Typically, the energy source will be moved to cover and treat a cylindrical volume of prostatic tissue surrounding the urethra. In such cases, the energy source will typically be rotated and/or axially translated within the urethra so that the energy is uniformly delivered into the urethral wall. Alternatively, the energy source may be scanned to a non-cylindrical and optionally non-symmetric region within the urethra which has been targeted for treatment. Various combinations of rotation, axial translation, rotational oscillation, and axial oscillation may be used.

Exemplary methods for treating a prostate comprise advancing a shaft through a urethra. An anchor on the shaft is expanded in a bladder to stabilize the shaft in the urethra, that is to fix the position relative to the urethral wall. The treatment device on the shaft is then activated to enlarge the urethra and/or debulk the prostate, where the position of the treatment device is fixed by the anchor. Usually, the anchor comprises a balloon which is inflated within the bladder, typically being inflated to fully occupy the entire volume of the urethra so that the risk of dislodgement is reduced. Actuating the treatment device may comprise use of any one of the energy sources described above, broadly including applying mechanical, vibrational, thermal, optical, and/or electrical energy to the prostatic tissue from the stabilized shaft. Usually, the treatment device will be moved relative to the shaft to treat a pre-defined surface region of the urethra, where the pre-defined surface region is usually cylindrical but may be non-cylindrical and non-symmetric as also described above. Typically, the treatment device emits a stream or circumferential band of energy, where movement comprises at least axial translation and/or axial oscillation. Usually, movement will further comprise rotation and/or rotational oscillation.

Examples of the present disclosure may provide prostate resection devices. Devices comprise a shaft, and at least one energy source. The shaft has a proximal end and a distal end. An expandable anchor may be positioned on the shaft near its distal end and is adapted for anchoring within the bladder. The at least one energy source is also on the shaft and may be spaced proximally of the anchor by a distance selected to position the energy source within a desired region of the urethra, typically within the prostate, when the anchor is positioned in the bladder. Thus, the energy may be delivered radially outwardly from the energy source selectively into the target prostate tissue without the need for imaging or other positioning methods or apparatus.

The prostate resection devices may further comprise various lumens in the shaft for performing supplemental portions of the procedure. For example, the shaft may comprise one or more lumens for delivering a gas or fluid to pressurize and enlarge (insufflate) the urethra surrounding the energy source. One or more additional lumens may be provided for aspirating the urethra to remove ablation products and/or for delivering fluids to flush the urethra to remove ablation or resection products. The shaft will be adapted for delivery in a retrograde direction into the male urethra, typically having a width in the range from <NUM> to <NUM> and a length in the range from <NUM> to <NUM>.

The prostate resection devices of the present invention may comprise any of the various energy sources described above. Usually, the energy source will be movable relative to the shaft to allow for selectively directing energy at different regions of the prostate. More typically, the energy source may be translated, rotated, translationally oscillated, and/or rotationally oscillated relative to the shaft. Exemplary energy sources comprise a high pressure fluid ejector, such as a nozzle or other port connected to additional lumen(s) in the shaft, a laser energy source, such as an optical fiber optionally combined with a mirror for reflecting the laser energy, a conductive fluid source in combination with a radiofrequency energy source, and/or an electrode that can be positioned against the urethral wall to deliver radiofrequency energy.

Referring to <FIG>, an exemplary prostatic tissue debulking device <NUM> which comprises a catheter assembly generally including a shaft <NUM> having a distal end <NUM> and a proximal end <NUM>. The shaft <NUM> will typically be a polymeric extrusion including one, two, three, four, or more axial lumens extending from a hub <NUM> at the proximal end <NUM> to locations near the distal end <NUM>. The shaft <NUM> will generally have a length in the range from <NUM> to <NUM> and a diameter in the range from <NUM> to <NUM>, usually from <NUM> to <NUM>. The shaft will have sufficient column strength so that it may be introduced upwardly through the male urethra, as described in more detail below.

The shaft will include an energy source positioned in the energy delivery region <NUM>, where the energy source can be any one of a number of specific components as discussed in more detail below. Distal to the energy delivery region, an inflatable anchoring balloon <NUM> will be positioned at or very close to the distal end <NUM> of the shaft. The balloon will be connected through one of the axial lumens to a balloon inflation source <NUM> connected through the hub <NUM>. In addition to the energy source <NUM> and the balloon inflation source <NUM>, the hub will optionally further include connections for an infusion/flushing source <NUM>, an aspiration (a vacuum) source <NUM>, and/or an insufflation (pressurized CO<NUM> or other gas) source <NUM>. the infusion or flushing source <NUM> can be connected through an axial lumen (not shown) to one or more delivery ports <NUM> proximal to the balloon anchor <NUM> and distal to the energy delivery region <NUM>. The aspiration source <NUM> can be connected to a second port or opening <NUM>, usually positioned proximally of the energy delivery region <NUM>, while the insufflation source <NUM> can be connected to an additional port <NUM>, also usually located proximal of the energy delivery region. It will be appreciated that the locations of the ports <NUM>, <NUM>, and <NUM> are not critical, and that the lumens and delivery means could be provided by additional catheters, tubes, and the like, for example including coaxial sleeves, sheathes, and the like which could be positioned over the shaft <NUM>.

Referring now to <FIG>, the prostatic tissue debulking device <NUM> is introduced through the male urethra U to a region within the prostate P which is located immediately distal to the bladder B. The anatomy is shown in <FIG>. Once the catheter <NUM> has been positioned so that the anchoring balloon <NUM> is located just distal of the bladder neck BN (<FIG>) the balloon can be inflated, preferably to occupy substantially the entire interior of the bladder, as shown in <FIG>. Once the anchoring balloon <NUM> is inflated, the position of the prostatic tissue debulking device <NUM> will be fixed and stabilized within the urethra U so that the energy delivery region <NUM> is positioned within the prostate P. It will be appreciated that proper positioning of the energy delivery region <NUM> depends only on the inflation of the anchoring balloon <NUM> within the bladder. As the prostate is located immediately proximal to the bladder neck BN and by spacing the distal end of the energy delivery region very close to the proximal end of the balloon, the delivery region can be properly located, typically having a length in the range from <NUM> to <NUM>, preferably from <NUM> to <NUM>. After the anchoring balloon <NUM> has been inflated, energy can be delivered into the prostate for debulking, as shown by the arrows in <FIG>. Once the energy has been delivered for a time and over a desired surface region, the energy region can be stopped and the prostate will be debulked to relieve pressure on the urethra, as shown in <FIG>. At that time, a flushing fluid may be delivered through port <NUM> and aspirated into port <NUM>, as shown in <FIG>. Optionally, after the treatment, the area could be cauterized using a cauterizing balloon and/or stent which could be placed using a separate catheter device.

Referring now to <FIG>, a number of representative energy delivery regions will be described. Referring now to <FIG>, a first exemplary prostate resection device <NUM> comprises a shaft <NUM> having a proximal end <NUM> and a distal end <NUM>. A plurality of nozzles <NUM> are mounted on the shaft <NUM> at a location spaced proximally from the distal end <NUM> by distance in the range from <NUM> to <NUM>. The nozzles, which are typically ceramic cores capable of generating a plasma or ports capable of directing a radially outward stream of electrically conductive fluid, may be mounted on structure <NUM>, which allows the nozzles <NUM> to be moved radially outwardly, as shown in broken line in <FIG>. An anchor <NUM>, shown as an inflatable balloon is mounted on the distal end <NUM> of the shaft <NUM> at a location between the nozzles <NUM> and the distal tip <NUM>. The expandable structure <NUM> will be capable of being expanded within the bladder to anchor the shaft <NUM> so that the nozzle array <NUM> lies within the prostate, as described in more detail below. The shaft <NUM> will include lumens, passages, electrically conductive wires, and the like, in order to deliver energy and materials from the proximal end <NUM> to the distal end <NUM> of the shaft. For example, an RF energy source <NUM> will be connected to the shaft <NUM>, usually to the nozzles <NUM>, in order to deliver RF energy to an electrically conductive fluid delivered from source <NUM> to the nozzles <NUM>, typically through a lumen within the shaft <NUM>. Other lumens, channels, or conduits will be provided in order to allow aspiration to a vacuum source <NUM> which is typically connected to one or more aspiration ports <NUM>. Other conduits may be provided within the shaft <NUM> in order to permit introduction of a flushing fluid, such as saline, from a source <NUM> to ports <NUM>. In other instances, it will be possible to connect the aspiration and flushing sources <NUM> and <NUM> to a common port so that aspiration and flushing may be conducted sequentially rather than simultaneously. Further optionally, internal lumens, conduits, or the like, may be provided in order to connect a source of insufflation <NUM> to one or more insufflation ports <NUM> on the shaft in the region of the array <NUM>. Finally, internal lumens, conduits, or the like, may be provided for connecting balloon <NUM> to a balloon inflation source <NUM>.

As shown in <FIG>, an exemplary energy delivery region <NUM> can be formed by a high pressure nozzle <NUM> which is carried on a delivery tube <NUM> which is disposed within the shaft <NUM>. Carrier tube <NUM> may be axially translated as shown by arrow <NUM> and/or rotated as shown by arrow <NUM> so that the high pressure stream <NUM> emanating from the nozzle <NUM> can be scanned or rastered over all or a selected portion of the urethra within the prostate. Specific pressures and other details for such high pressure water treatment are described, for example, in Jian and Jiajun, supra.

Referring now to <FIG>, the energy source within the energy delivery region <NUM> may comprise a fiberoptic waveguide or fiber bundle <NUM> carried on the rotating and translating shaft <NUM>. The optical waveguide <NUM> transmits laser or other coherent optical energy in a beam <NUM> which may be scanned or rastered over the urethral wall and prostatic tissue by rotating and/or translating the carrier tube <NUM>.

As shown in <FIG>, laser energy from an optical waveguide or fiber bundle <NUM> may be directed axially against a mirror <NUM>, where the waveguide and mirror are both carried on the rotating and axially translating carrier tube <NUM>. Again, by rotating and/or translating the carrier tube <NUM>, the emanating beam <NUM> can be scanned or rastered over the urethral wall.

Referring now to <FIG>, the rotating and axially translating tube <NUM> may carry an electrode <NUM> which projects laterally from the tube. The electrode <NUM> will be adapted for connection to a radiofrequency energy source so that, when the electrode contacts the urethral wall and prostatic tissue, radiofrequency energy can be delivered, either in a monopolar or bipolar mode. The radiofrequency energy can thus ablate the tissue over selected volumes and regions of the prostatic tissue. Optionally, by changing the nature of the radiofrequency energy, the electrode <NUM> could also be used to cauterize the tissue after it has been treated.

Claim 1:
A prostate treatment device (<NUM>) comprising:
a shaft (<NUM>) configured to be introduced through an urethra, the shaft (<NUM>) having a proximal end (<NUM>) and a distal end (<NUM>);
at least one energy source (<NUM>) positioned in an energy delivery region (<NUM>) on the shaft (<NUM>) configured to deliver energy radially outwardly;
an aspiration lumen on the shaft (<NUM>) configured to remove tissue; and
a lumen in the shaft (<NUM>) configured to flush with a fluid to help remove the tissue;
wherein the energy source (<NUM>) is adapted to be translated and rotated relative to the urethra.