Water enucleation of prostate

Abstract

To provide improved methods and apparatus for treating the prostate.SOLUTION: Embodiments of the present invention provide improved methods and apparatus of treating the prostate. In many embodiments, at least a portion of the prostate is enucleated with a water jet, in order to decrease the invasiveness of the surgery. The access to the prostate can be provided with one or more of open surgical access, percutaneous access or urethral access. The prostate can be enucleated such that an inner portion of the prostate comprising adenomatous tissue of the prostate is separated from an outer portion of the prostate comprising the capsule. In many embodiments, a patient is treated with energy of the water jet configured to separate the capsule from the inner tissue of the prostate and to inhibit cutting of blood vessels.SELECTED DRAWING: None

Description

[Technical field]

[0001] (cross reference) This application claims the benefit of U.S. Provisional Application No. 61 / 808,197, filed April 3, 2013, which is incorporated herein by reference.

[0002] The invention of this application is disclosed in the following U.S. patents and pending applications: 12 / 399,585, entitled "TISSUE ABLATION AND CAUTERY WITH OPTICAL ENERGY CARRIED IN FLUID STREAM," filed March 6, 2009 (published as US20090227998, [Attorney Docket No. 41502-704.201]); 12 / 700,568, entitled "MULTI FLUID TISSUE RESECTION METHODS AND DEVICES," filed February 4, 2010 (published as US20110184391, [Attorney Docket No. 41502-703.501]); 12 / 700,568, entitled "MINIMALLY INVASIVE METHODS AND DEVICES FOR THE TREATMENT OF PROSTATE," issued February 8, 2011 (published as US20110184391, [Attorney Docket No. 41502-703.501]); No. 7,882,841, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," filed on February 28, 2013 ([Attorney Docket No. 41502-705.601]), and is hereby incorporated by reference in its entirety.

[0003] The field of the invention relates to the treatment of tissue, and more particularly, to the treatment of organs such as the prostate using fluid stream energy. [Background technology]

[0004] (background) Previous methods and devices for treating tissue-related disorders may be sub-ideal, at least in some cases. For example, the prostate may swell with age and require removal. In some cases, the prostate may consist of cancerous tissue and require removal. In either case, surgical removal of the prostate may be more invasive and require longer recovery times than would be ideal.

[0005] Surgical removal of the prostate has been proposed and performed to remove the prostate. Surgical removal of the prostate offers the potential to remove enlarged prostatic tissue, such as prostatic adenomas. However, surgical removal of the prostate may be more invasive than would be ideal and may rely on an open incision. Percutaneous access of the prostate can provide for the removal and effective removal of enlarged prostatic tissue and can be provided using access through the patient's skin and bladder to access the prostate. However, the recovery time for percutaneous removal of the prostate may be longer than would be ideal. Recently, Holmium Laser Resection of the Prostate (hereinafter "HOLEP") has been proposed. Transurethral removal of the prostate has the advantage of being minimally invasive, since the prostate can be accessed through the urethra. However, transurethral removal is a complex and delicate procedure that may require significant surgical skills, and is possibly not readily available to many patients due to the complexity of the procedure and the surgical skills required. Additionally, HOLEP has the disadvantages of patient bleeding and recovery times that may, at least in some cases, be sub-ideal.

[0006] In light of the foregoing, it would be useful to provide improved methods and devices for treating the prostate. Ideally, such methods and devices would be minimally invasive, provide improved outcomes, and be easily practiced by many surgeons so that many patients would be able to benefit. At least some of these objectives will be met by the inventions described herein. Summary of the Invention [Means for solving the problem]

[0007] (summary) The present invention provides an improved method and apparatus for treating the prostate. In many embodiments, at least a portion of the prostate is removed using a water jet to reduce the invasiveness of the surgery. Access to the prostate can be provided using one or more of open surgical access, percutaneous access, or urethral access. The prostate can be removed such that an inner portion of the prostate consisting of adenomatous tissue of the prostate is separated from an outer portion of the prostate consisting of the capsule. In many embodiments, the patient is treated with the energy of the water jet configured to separate the capsule from the inner tissue of the prostate and to prevent cutting of collagen-rich tissue such as blood vessels and the capsule of the prostate. In many embodiments, the urethral wall is ablated using a water jet at a first luminal location near the neck of the bladder and a second luminal location near the verumontanum of the urethra, the second luminal location being from the verumontanum toward the bladder neck. The prostate is composed of three glandular lobes, two lateral lobes and one medial lobe. The lobes can be extracted in a number of ways, but in many embodiments, at least a portion of each of the three lobes are extracted separately using a water jet to reduce the invasiveness of the surgery. Alternatively, or in combination, two or more lobes can be extracted together, such as using open surgical access.

[0008] The energy of the water jet may be adjusted in one or more of a number of ways to provide for removal of the prostate with less vascular disruption to reduce the invasiveness of the procedure. In many embodiments, the jet is adjusted to a first amount of energy to ablate the urethra and a second amount of energy to separate the inner prostate tissue from the capsule as it is removed. In many embodiments, the entrained area of ​​the jet can be imaged, for example optically or with ultrasound, and the visible area of ​​the jet is adjusted to configure the water jet for one or more of ablation of the urethra or separation of the capsule from the inner prostate tissue.

[0009] In many embodiments, the visible region of the jet comprises an entrainment region of cavitation that increases scattering of imaging energy, e.g., optical or ultrasound imaging energy, transmitted through the jet when configured to ablate tissue, such that the jet appears in images as a cold flame. In many embodiments, the visible region of the jet, comprised of an entrainment region extending from the orifice to the visible flame tip, can be adjusted under user visibility to a length within the range of about 2-5 mm, such that the probe can be used to ablate the urethra. Separation of the capsule from the inner layer of the prostate can be provided with a visible jet length within the range of 1-5 mm, e.g., 1-3 mm.

[0010] The visible area of ​​the entrainment region of the jet can be adjusted using one or more of pressure, the flow rate of the liquid through the probe, or the opening of the orifice of the probe. In many embodiments, the probe is selected based on the orifice of the probe to provide a desired "flame zone" length from the orifice to the tip of the "flame zone" of the entrainment region. In many embodiments, the fluid stream comprises a diverging fluid stream such that cutting of collagen tissues such as the urethra and blood vessels at a distance beyond the tip of the flame zone is prevented.

[0011] Research related to the embodiments suggests that removal can be provided using fluid flow at a distance beyond the tip of the entrainment region of cavitation that comprises the "flame region", such that removal can be provided by separating the capsule from the inner prostate tissue at a distance beyond the tip of the "flame region". As a result, severing of blood vessels can be further prevented during separation of the capsule from the inner prostate tissue with appropriate adjustment of the water jet to separate the capsule of the prostate from the inner layer. In many alternative or combination embodiments, the distance from the orifice to the tip of the entrainment region that comprises the low temperature flame can be reduced after cutting the urethra, further preventing severing of blood vessel tissue during separation of the capsule from the inner prostate tissue. Alternatively or in combination, a first probe with a first orifice can be selected and advanced into the urethra to cut the urethra, and a second probe with a second orifice can be used to separate the inner prostate from the capsule.

[0012] In many embodiments, urethral access to the prostate gland is provided through the natural opening of the urethra outside the patient. This urethral access has the advantage of reducing the invasiveness of the surgical procedure. Several instruments can be introduced into the urethra, such as an endoscope for visualizing the treatment area, an elongated treatment probe with an opening for a water jet, and a morcellation probe for separately morcellating at least a portion of each lobe of the prostate gland from within the bladder. The water jet can be used to cut the urethra near the bladder neck and near the verumontanum under endoscopic visualization. At least a portion of each lobe of the prostate gland can be separately extracted and advanced into the bladder. Each extracted lobe of the prostate gland can be morcellated from within the bladder.

[0013] The water jet can be combined with one or more of many additional surgical configurations such as suction of the urethra, morcellation of each of the excised lobes of the prostate, and laser energy delivery through the water jet orifice for one or more of cauterization, laser cutting, or laser irradiation of the excised material with the jet. Alternatively, or in combination, the water jet may comprise a water hammer that strikes the tissue for separation, and a bag may be placed over the water jet such that a portion of the bag is impacted by the water jet.

[0014] Aspects of the present disclosure provide a method of at least partially removing a prostate. A probe may be advanced at least partially into a patient. The patient's urethra may be ablated at a first location and a second location using a water jet. Medial tissue of the prostate may be separated from the prostate capsule using the water jet.

[0015] The probe may be advanced into the patient using one or more of open surgical access, percutaneous access, or urethral access. A first location where the urethra may be resected may be located near the bladder neck of the urethra, and a second location may be located near and from the verumontanum toward the bladder neck. The resection of the urethra may consist of multiple resections extending between the first and second locations, and the multiple resections may extend from the urethra to the capsule.

[0016] The energy of the water jet may be adjusted to separate the capsule from the inner tissue and prevent ablation of the capsule and blood vessels. The water jet may comprise a diverging stream. The energy of the water jet may be adjusted based on an image of an entrained area of ​​the water jet as the probe is inserted, at least in part, into the urethra. The water jet may be adjusted to a first amount of energy to ablate the urethra and a second amount of energy to separate the outer capsule of the prostate from the inner tissue at the first and second locations.

[0017] A first orifice of the first probe may be used to provide a jet to resect the urethra, and a second orifice of the second probe may be used to provide a jet to separate the capsule from the inner prostate tissue.

[0018] A probe may be advanced into the natural opening of the urethra to access the urethra. The urethra is resected at a first location and a second location with a first probe having a jet extending to a side of the first probe to resect the urethra. The capsule may be separated from the inner layer with a second probe having a jet extending from an end of the probe at a different angle than the first probe.

[0019] Aspects of the present disclosure provide, at least in part, an apparatus for removing a prostate gland of a patient. The apparatus may include, at least in part, a probe for advancing into the patient. The probe may be configured to provide a water jet at a first location and a second location to ablate the patient's urethra and separate inner prostate tissue from the prostate capsule.

[0020] The probe may be configured to advance into the patient using one or more of open surgical access, percutaneous access, or urethral access. The probe may be configured to provide a water jet to a first location located at the urethra near the bladder neck and a second location located near the verumontanum and from the verumontanum toward the bladder neck. The probe may be configured to ablate the urethra with multiple ablations extending between the first and second locations. The multiple ablations may extend from the urethra to the capsule.

[0021] The energy of the water jet may be adjustable to separate the capsule from the inner tissue and prevent ablation of the capsule and blood vessels. The water jet may comprise a diverging stream. The energy of the water jet may be adjustable based on an image of the entrained area of ​​the water jet when the probe is inserted at least partially into the urethra. The water jet may be adjustable to a first amount of energy to ablate the urethra and a second amount of energy to separate the outer capsule of the prostate from the inner tissue at the first and second locations.

[0022] The first orifice of the first probe may be configured to provide a jet to ablate the urethra, and the second orifice of the second probe may be configured to provide a jet to separate the capsule from the inner prostate tissue. The probes may be configured to advance into the natural opening of the urethra to access the urethra. The probes may be configured to ablate the urethra at a first location and a second location with a first probe having a jet extending to a side of the first probe to ablate the urethra. The second probe may be configured to separate the capsule from the inner layer with the second probe having a jet extending from an end of the probe at a different angle than the first probe. The present specification also provides, for example, the following items: (Item 1) 1. A method of at least partially removing a prostate, the method comprising: advancing a probe at least partially into the patient; ablating the patient's urethra at a first location and a second location using a water jet; using the water jet to separate the inner prostate tissue from the prostate capsule; A method comprising: (Item 2) 2. The method of claim 1, wherein the probe is advanced into the patient using one or more of open surgical access, percutaneous access, or urethral access. (Item 3) 2. The method of claim 1, wherein the first location is located near the bladder neck of the urethra and the second location is located near the verumontanum and from the verumontanum toward the bladder neck. (Item 4) 2. The method of claim 1, wherein the urethral resection comprises a plurality of resections extending between the first location and the second location, the plurality of resections extending from the urethra to the capsule. (Item 5) 2. The method of claim 1, wherein the energy of the water jet is adjusted to separate the capsule from the inner tissue and prevent ablation of the capsule and blood vessels. (Item 6) 2. The method of claim 1, wherein the water jet comprises a diverging stream. (Item 7) 8. The method of claim 1, wherein the energy of the water jet is adjusted based on an image of an entrainment region of the water jet as the probe is inserted, at least in part, into the urethra. 2. The method of claim 1, wherein the water jet is adjusted at the first location and the second location to a first amount of energy to ablate the urethra and a second amount of energy to separate the outer capsule of the prostate from the inner tissue. (Item 9) 2. The method of claim 1, wherein a first orifice of a first probe is used to provide a jet to resect the urethra and a second orifice of a second probe is used to provide a jet to separate the capsule from the inner prostate tissue. (Item 10) 2. The method of claim 1, wherein the probe is advanced into a natural opening of the urethra to access the urethra, the urethra is resected at the first location and the second location with a first probe having a jet extending to a side of the first probe to resect the urethra, and the capsule is separated from the inner layer with a second probe having a jet extending from an end of the probe at a different angle than the first probe. (Item 11) 1. An apparatus for at least partially removing a prostate gland in a patient, comprising: The apparatus comprises, at least in part, a probe for advancing into the patient, the probe configured to provide a water jet at a first location and a second location to ablate the patient's urethra and separate inner prostate tissue from the prostate capsule. (Item 12) Item 12. The apparatus of item 11, wherein the probe is configured to be advanced into the patient using one or more of open surgical access, percutaneous access, or urethral access. (Item 13) Item 12. The apparatus of item 11, wherein the probe is configured to provide the water jet to a first location located in the urethra near a bladder neck and a second location located near the verumontanum and from the verumontanum toward the bladder neck. (Item 14) Item 12. The apparatus of item 11, wherein the probe is configured to ablate the urethra with a plurality of ablations extending between the first location and the second location, the plurality of ablations extending from the urethra to the capsule. (Item 15) 12. The apparatus of claim 11, wherein the energy of the water jet is adjustable to separate the capsule from the inner tissue and prevent ablation of the capsule and blood vessels. (Item 16) Item 12. The apparatus of item 11, wherein the water jet comprises a diverging stream. (Item 17) Item 12. The apparatus of item 11, wherein the energy of the water jet is adjustable based on an image of an entrainment region of the water jet when the probe is inserted, at least in part, into the urethra. (Item 18) Item 12. The apparatus of item 11, wherein the water jet is adjustable at the first location and the second location to a first amount of energy to ablate the urethra and a second amount of energy to separate the outer capsule of the prostate from the inner tissue. (Item 19) Item 12. The apparatus of item 11, wherein a first orifice of a first probe is configured to provide a jet to resect the urethra and a second orifice of a second probe is configured to provide a jet to separate the capsule from the inner prostate tissue. (Item 20) 20. The apparatus of claim 19, wherein the probes are configured to advance into a natural opening of the urethra to access the urethra, and the probes are configured to ablate the urethra at the first location and the second location with a first probe having a jet extending to a side of the first probe to ablate the urethra and a second probe configured to separate the coating from the inner layer with a second probe having a jet extending from an end of the probe at a different angle than the first probe.

[0023] A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 shows a patient's anatomy, with a prostate and verumontanum and bladder suitable for integration, according to an embodiment. [Figure 2A] FIG. 2A illustrates transcutaneous resection of the prostate through the bladder, according to an embodiment. [Figure 2B] FIG. 2B illustrates the ablation of tissue near the bladder neck with a water jet and severing the urethra at a first location near the bladder neck, according to an embodiment. [Figure 2C] FIG. 2C illustrates removal of at least a portion of the prostate gland using a water jet to separate the inner tissue of the prostate gland from the capsule, according to an embodiment. [Figure 2D] FIG. 2D illustrates a portion of the extracted prostate being advanced into the bladder and separation of the capsule from an inner portion of the prostate near a second location of the urethra between the bladder neck and the verumontanum, according to an embodiment. [Figure 3A] FIG. 3A shows the bladder neck and probe as viewed through an endoscope using urethral access. [Figure 3B] FIG. 3B shows the probe oriented for a 7 o'clock cutting path along the urethra from the bladder neck to the verumontanum. [Figure 3C] FIG. 3C shows the probe oriented for a 5 o'clock cutting path along the urethra from the bladder neck to the verumontanum. [Figure 4] FIG. 4 is a graph of tissue ablation rate demonstrating the critical pressure. [Diagram 5] FIG. 5 illustrates a columnar and diverging fluid flow. [Figure 6A] FIG. 6A shows a multi-purpose sheath and manifold, according to an embodiment. [Figure 6B] FIG. 6B shows manifold conduits of a manifold such as that of FIG. 6A configured for the transmission and reception of multiple fluids while the manifold remains connected to a patient, according to an embodiment. [Figure 6C] FIG. 6C illustrates components of a treatment probe and linkage, according to an embodiment. [Figure 6D1] FIG. 6D1 illustrates rapid exchange of a carrier when a link is coupled to an elongate element anchored to a target location of an organ, according to an embodiment. [Figure 6D2] FIG. 6D2 shows alignment of the distal tip of the carrier with the proximal end of the linkage for insertion of a carrier tube as in FIG. 6D1. [Figure 6D3] FIG. 6D3 shows the carrier advanced towards the locking structure on the proximal end of the linkage as in FIG. 6D1. [Figure 6D4] FIG. 6D4 shows a carrier locked to a link like those of FIGS. 6D1 and 6D2. [Figure 6E] FIG. 6E illustrates a cystoscope at least partially inserted into an elongate element for advancement toward the bladder neck to view tissue of an organ such as the prostate, according to an embodiment. [Figure 6F] FIG. 6F shows the advancement of the elongate element into the sheath. [Figure 6G] FIG. 6G shows a linkage connected to an extension element comprising a spine, according to an embodiment. [Figure 6H] FIG. 6H shows a carrier tube and carrier inserted into a chain tube, according to an embodiment. [Figure 7] FIG. 7 illustrates a scan pattern for a fluid flow, according to an embodiment. [Figure 8] FIG. 8 illustrates a bag covering a fluid flow that includes a water hammer, according to an embodiment. [Figure 9A] 9A and 9B show variations in jet angle according to an embodiment. [Figure 9B] 9A and 9B show variations in jet angle according to an embodiment. [Figure 10] FIG. 10 illustrates a morcellation procedure, according to an embodiment. [Figure 11] 11A-11C show a single tube design, according to an embodiment. [Figure 12] FIG. 12 illustrates tissue ablation and depth control, according to an embodiment. [Figure 13] FIG. 13 shows the visible entrainment area at a first size as shown in FIG. [Figure 14] FIG. 14 illustrates tissue ablation depth control, according to an embodiment. [Figure 15] FIG. 15 shows an optical image of the entrainment region "flame zone" in saline as shown in FIG. 14 but with different pressures than those shown in FIGS. 12 and 13, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] (Detailed Description) A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:

[0026] Although the detailed description contains many details, these should not be construed as limiting the scope of the disclosure, but merely as illustrating different embodiments and aspects of the disclosure. It should be understood that the scope of the disclosure includes other embodiments not discussed in detail above. Various other modifications, changes, and variations, which will be apparent to those skilled in the art, may be made in the arrangement, operation, and details of the methods and apparatus of the disclosure provided herein without departing from the spirit and scope of the invention as described herein.

[0027] The embodiments disclosed herein may be combined in one or more of many ways to provide improved treatment to patients. The disclosed embodiments can be combined with methods and devices of the prior art to provide improved treatment, such as, for example, combination with known methods of prostate surgery and surgery of other tissues and organs. It should be understood that any one or more of the structures and steps as described herein can be combined with any one or more additional structures and steps of the methods and devices as described herein, and the drawings and supporting text provide an explanation according to the embodiments.

[0028] As used herein, like characters distinguish between like elements.

[0029] FIG 1 illustrates a patient's anatomy, with a prostate, verumontanum, and bladder suitable for integration, according to an embodiment. FIG 1A further illustrates the ureteral openings of the bladder, the openings of the prostatic ducts, the ejaculatory ducts, and the sphincter of the bladder.

[0030] 2A-2D show a method for percutaneous removal of the prostate using a water jet.

[0031] 2A shows a transcutaneous resection of the prostate through the bladder according to an embodiment. An endoscope and probe are advanced across the skin into the bladder through percutaneous access. The distal end of the probe is positioned near the bladder neck and directs a cutting jet toward the prostate.

[0032] 2B illustrates the dissection of tissue near the bladder neck with a water jet and severing the urethra at a first location near the bladder neck, according to an embodiment, and further illustrates the water jet projected from the probe along the path of the incision.

[0033] FIG. 2C illustrates removal of at least a portion of the prostate gland using a water jet to separate the inner tissue of the prostate gland from the capsule, according to an embodiment.

[0034] FIG. 2D shows, according to an embodiment, a portion of the extracted prostate gland being advanced into the bladder and separation of the capsule from an inner portion (or inner tissue) of the prostate gland near a second location (second location) of the urethra between the bladder neck and the verumontanum.

[0035] 3A-3C show a method for transurethral removal of the prostate using a water jet.

[0036] FIG. 3A shows the bladder neck and probe as viewed through an endoscope using urethral access.

[0037] FIG. 3B shows the probe oriented for a 7 o'clock incision or cutting path along the urethra from the bladder neck to the verumontanum.

[0038] FIG. 3C shows the probe oriented for a 5 o'clock incision or cutting path along the urethra from the bladder neck to the verumontanum.

[0039] An important aspect of ablating tissue in a multi-tissue environment according to the present embodiment is the ability to operate with a treatment plan where one tissue type is ablated while another tissue type remains substantially undamaged. This occurs most notably when operating at a pressure between the critical pressures of the two tissue types. As can be seen in FIG. 4, the operating pressure p0 of the fluid flow is greater than the critical pressure of tissue 1 (p0>p0) such that tissue 1 undergoes an ablation rate greater than 0. crit1 ) on the other hand, a pressure p0 below the critical pressure of tissue 2 (p0 <p crit2), in such a configuration, the fluid flow is said to be configured to selectively ablate tissue 1 but not tissue 2.

[0040] In one embodiment configured to treat BPH, the fluid flow source pressure is configured to be above the critical pressure of prostatic tissue but below the critical pressure of non-prostatic tissue. In such an embodiment, the pressure is high enough to ablate glandular tissue, but not so low that it ablates intraprostatic blood vessels, fibromuscular stroma, film The fluid delivery element is preferably pressurized to a pressure in the range of about 1-30,000 psi, more preferably to a pressure in the range of about 50-1,500 psi, and most preferably to a pressure in the range of about 100-1,000 psi, prior to exiting the fluid delivery element.

[0041] In addition, it is contemplated that the shape of the fluid stream also affects selective ablation. Although the fluid stream is illustratively shown in FIG. 5 as a columnar fluid stream 333 or a diverging fluid stream 334, it is contemplated that the fluid stream may be of any shape or configuration that enables ablation in accordance with embodiments of the present invention. In particular, there are numerous advantages to both columnar and diverging fluid stream configurations, as described in further detail below.

[0042] In the columnar fluid stream configuration 333, the device emits the fluid stream as a substantially focused rod-like fluid stream with a substantially zero divergence angle. In one embodiment, the columnar fluid stream is configured as a generally straight or non-diverging fluid stream. In such a configuration, the device emits the fluid stream as a substantially cylinder or other non-diverging shape, thereby delivering energy to tissue over an area or spot size that is largely independent of the tissue distance from the fluid delivery element. Optionally, the fluid stream may be adjusted to converge in order to focus the energy delivered to the tissue, for example, if the fluid delivery element includes multiple nozzles or if the fluid contains gas bubbles.

[0043] FIG. 6A illustrates a multi-purpose sheath and manifold, according to an embodiment. The manifold 468 is configured to transmit multiple fluids to and from a work site. The manifold 468 is rigidly coupled, e.g., affixed, to the spine 452. The sheath 458 can be positioned around the spine 452 and extend inwardly toward the manifold 468. The manifold 468 is coupled to the support 438 in the linkage 430 with a locking element 460. The manifold 468 can be decoupled from the linkage 430 and the support 438 to remove the linkage 430 and the support 438 to allow additional components to be inserted into the working channel. For example, an endoscope can be inserted into the working channel to extend toward a working area of ​​an organ, e.g., the prostate. A structure 462 with protruding portions extends toward the manifold 468. The structure 462 is shaped to engage the manifold 468 and allow removal of the structure 462, the linkage 430, and the support 438 when the locking element 460 is disengaged. The manifold 468 includes a structure 464 that engages a protruding portion of the structure 462. A number of seals are arranged on the manifold 468 to allow removal of the structure 462. When the structure 462 is removed, an endoscope or other surgical tool can be inserted into the working space and advanced toward the treatment site. For example, an endoscope can be advanced toward the treatment site, which will be the treatment area. The manifold includes a number of ports that are coupled to the treatment site to allow fluid to be communicated and removed from the treatment site. For example, when an endoscope is positioned at the treatment site. The locking element and manifold allow removal of the linkage and treatment probe such that the manifold 468 remains coupled to the sheath 458 and spine 452 within the patient.

[0044] In many embodiments, a treatment probe and carrier as described herein, e.g., a tubular carrier, can be inserted and removed while locking element 460 engages linkage 430 and support 438. This configuration of linkage, locking element, and support allows the probe to be quickly and easily removed and reinserted to provide beneficial treatment.

[0045] Multi-purpose sheaths and manifolds as described herein have the benefit of allowing the sheath, manifold, spine, and anchors to remain attached to the patient while additional surgical tools are employed. Locking elements interface with multiple instruments allowing for placement, visualization, and aquablation and aquabeam operation without reintroduction or movement with respect to tissue. Multiple sealed conduits allow sheath ports to be used to transmit various fluid flows or pressures within or parallel to the working channel. The working channel may be used for visualization access to the anatomy via existing rigid or flexible endoscopic techniques. The working channel has a large bore to accommodate many types of tools and allow free flow of tissue and fluids. Alternative energy delivery devices may be used within the sheaths or working channels as described herein.

[0046] In many embodiments, the working channel is sized to allow for multiple carriers within the working channel, for example, an endoscope carrier within the working channel, and a treatment probe carrier as described herein within the working channel to allow visualization of the treatment site while the treatment probe is performing aquablation and aquabeam operations as described herein.

[0047] FIG. 6B shows a manifold conduit of the manifold configured to transmit and receive a plurality of fluids while the manifold remains connected to the patient. The manifold is coupled to a plurality of ports 456. The plurality of ports 456 may include an auxiliary fluid port 456A, a balloon pressure port 456B, and a tissue removal port 456C. A sheath 458 extends circumferentially around the spine 452. The spine 452 and the sheath 458 may be rigidly coupled to the manifold portions and provide connections and channels coupled to the manifold portions. A channel 467, e.g., a tubular channel, is connected to the port 456B to allow for inflation of the balloon. A channel 469 may be defined with the sheath 458. The channel 469 may be coupled to the port 456A to provide an auxiliary fluid to the treatment site. A port 456C to allow for removal of tissue may be coupled to the main working channel 465. A main working channel 465 can extend from port 456C to the treatment site. A number of seals 466 are arranged to separate the treatment ports and channels as described herein. A manifold 468 can be decoupled from linkage 430 and support 438 to allow balloon inflation pressure to be applied through port 456B. Auxiliary fluid can be provided through port 456A, for example, to flush working channel 465. This configuration of the manifold allows spine 452 and anchors 24 to remain in place while other instruments are inserted into the working channel.

[0048] Multiple manifold conduits as described herein allow tissue collection to be routed through a large diameter working channel 469 to reduce flow obstruction. Balloon pressure can be transferred from a luer fitting to the distal tip of the anchor with a small diameter tube, for example, a tube defining channel 467. Auxiliary fluid is transferred to the treatment area between the sheath and spine using channel 469.

[0049] FIG. 6C shows the components of the treatment probe and linkage disassembled prior to use. Linkage 430 comprises a casing 410 and a cover 412. Cover 412 can be placed over a lower portion of casing 410. The cover and casing can comprise a rigid material to add rigidity. The casing and cover can be sized to comprise a handpiece containing linkage 430. Linkage 430 comprises an elongated tubular structure comprising a gear 433 that engages another gear 434 of the linkage. Gear 434 can be positioned on the movable carriage 413. The elongated tubular structure can comprise a second movable portion 436 of the linkage. Casing 410 can comprise a support 438 for the linkage. Gear 433 remains connected to elongated tubular structure 431 when the linkage is disassembled. The movable portion of linkage 430 may include gear 433, gear 434, and movable carriage 413 to advance elongated structure 431 distally when connected to a second movable portion 436 as shown by arrow 418. Cover 412 includes flange 416. The elongated structure may be locked into position 431 on the linkage when the cover is placed over the casing.

[0050] The extension element 310 includes a spine 452 and is shown covered by a sheath 458, as described herein. The sheath 458 includes a channel to receive the extension element 310. The extension element 310 includes a working channel and can be inserted into the sheath 458 such that the extension element is covered by the sheath 458. The sheath 458 and extension element 310 are shown connected to a manifold 468, as described herein.

[0051] The sheath 458 can be inserted into the patient prior to insertion of the extension element 310. In many embodiments, the sheath 458 is coupled to a manifold 468 when inserted into the patient.

[0052] The extension element 310 is configured to slide into the sheath 458 such that the extension element 310 and the sheath comprise a locking configuration. The extension element 310 comprises a structure 411 configured to engage the linkage housing 410 such that the extension element 310 and the housing 410 remain substantially fixed when the extension structure 431 moves as described herein.

[0053] In many embodiments, the casing 410 comprises supports 438. The supports 438 may comprise a substantially stationary portion of the linkage 430, as described herein. The linkage 430 may comprise a moving carriage 433 to move the carrier 382 when the casing 410, comprising the supports 438, is locked to the arm, as described herein, and remains substantially stationary.

[0054] In many embodiments, the structure 411 of the extension element 310 comprises a locking structure to form a locking joint with the casing 410 and the cover 412 .

[0055] In many embodiments, the manifold 468 can be connected to the sheath 458 and affixed to the sheath such that the sheath 458 can be inserted into a patient and the manifold 468 can be used to inflate the balloon anchor 24 as described herein. The extension element 310 with the spine 452 can then be inserted into the sheath 458. The manifold 468 and structure 411 include a locking structure 417 to lock the manifold to the extension element 310 when the extension element 310 is inserted into the manifold 468 and sheath 458. The release 415 can be pressed by a user to release the manifold 468 from the extension element 310.

[0056] The elongated tubular structure 431 of the linkage 430 comprises structure for receiving the carrier tube 380. An opening 409 in the elongated tubular structure 431 is sized to receive the carrier tube 380. A connecting structure 408 is shown on the proximal end of the linkage and comprises a locking structure 406 for receiving a protrusion 404 of a connecting structure 405 of the carrier tube 308.

[0057] 6D1 shows the rapid exchange of the carrier tube 380 when the linkage 430 is coupled to the elongate element 310 anchored at the target location of the organ. The elongate element 410 can be inserted or removed from the linkage by the user. The elongate element 380 can be advanced into the opening 409 near the connecting structure 405 of the elongate tubular structure 431.

[0058] The imaging probe 460 can be mounted on a second linkage and configured to move with the nozzle of the carrier 382 to image the interaction of the energy stream from the carrier 382 as tissue is treated. The images of the treatment may comprise axial and sagittal images from the imaging probe 460. The linkage can be coupled to a controller or processor (or both) as described herein, for example, to move the imaging probe 460 synchronously along an axis with the carrier 382 and the nozzle of the carrier. The imaging probe 460 may comprise a transrectal ultrasound probe and the carrier 482 may comprise components of the treatment probe 450 as described herein.

[0059] FIG. 6D2 shows alignment of the distal tip of carrier 382 with opening 409 at the proximal end of elongated tubular structure 431 for insertion of carrier tube 380 as in FIG. 6D1.

[0060] 6D3 shows the carrier advanced towards the locking structure 406 on the proximal end of the linkage as in FIG. 6D1. The locking structure 406 is sized to receive the protrusion 404 to form the locking joint 402.

[0061] Figure 6D4 shows carrier tube 380 locked to linkage 430 as in Figures 6D1 and 6D2. Protrusion 404 is inserted into opening of locking structure 406 to form a locking joint. The joint can be released by user action.

[0062] 6E shows a cystoscope at least partially inserted into the sheath 458 for advancement towards an anchoring location of an organ. The anchoring location may comprise the bladder neck to visualize tissue of an organ such as the prostate. The sheath 458 as described herein can be advanced to the target location with visualization from the cystoscope disposed within the working channel of the elongate element 310. When positioned, an anchor 24, such as a balloon, can be inflated using a port of a manifold 468 coupled to the sheath as described herein.

[0063] There are at least two forms of visualization that are possible with the embodiments as described herein: 1) A cystoscope is locked within the sheath 458. The goal may be to visualize the prostate and then ultimately leave the sheath as a safe channel to guide the elongated element 310 with spine 452 into the patient, in many embodiments without direct visualization. The distal end of the sheath lines up near the bladder neck. 2) Once the elongated element 310 is locked into the sheath 458, a ureteroscope can be used to visualize the patient. The ureteroscope can be inserted inside the same channel where the carrier 380 enters, for example, a shared channel.

[0064] 6F shows the advancement of the extension element 310 into the sheath 458. The manifold 468 on the proximal end of the sheath 458 may include a locking structure to receive the locking structure on the proximal end of the extension element 310. The extension element 310 can be advanced into the sheath 458 such that the locking element on the sheath 458 and the extension element 310 engage.

[0065] 6G shows a linkage 430 coupled to an extension element 310 that comprises a spine 452. The linkage is configured to receive a carrier 382 and a carrier tube 380 as described herein.

[0066] FIG. 6H shows the carrier tube and carrier inserted into the tether tube in a locked configuration as described herein.

[0067] 6A-6H illustrate a method of treating a patient, according to an embodiment, each of which illustrates one or more optional steps of the method.

[0068] FIG. 7 illustrates a scan pattern of a fluid stream as described herein. The fluid stream may comprise a pulsed or continuous fluid stream. The scan pattern may be based on a critical pressure as described herein to remove a first tissue and prevent removal of a second tissue. In many embodiments, the fluid stream comprises a plurality of pulses 810 from a pump, such as a piston pump, the pulses comprising a frequency and duty cycle. In many embodiments, the duty cycle corresponds to no more than about 50%. The plurality of pulses 810 comprises a first pulse 812 and a second pulse 814. The fluid flame may comprise an approximate cross-sectional size at the location of the tissue being scanned. Based on the teachings described herein, one of ordinary skill in the art will recognize that the fluid flame comprises a maximum cross-sectional width at about ½ the length of the fluid flame. At the location where the fluid flame impacts the tissue, the fluid flame comprises a cross-sectional size 848.

[0069] The scan pattern of the fluid stream comprising the fluid flame is along the Z axis and angle 844. The angle 844 may correspond to a time 845, e.g., when the angular sweep rate remains substantially constant. The fluid flame is scanned along a scan path 846. The scan path 846 may correspond to, e.g., a velocity of the carrier 382 along the Z axis and a rotation of the carrier 382 about the Z axis.

[0070] The pulses can be spaced such that multiple successive pulses strike tissue location 830. Multiple successive pulses can be effective in removing a first type of tissue while preventing removal of a second type of tissue.

[0071] Alternatively, or in combination with a critical pressure as described herein, work related to embodiments suggests that the rate of removal may be related to the relaxation time of the target tissue. The fluid flame can be configured to dwell over the tissue point 830 for a duration longer than the tissue's relaxation time such that the tissue can be deformed and removed beyond a threshold value.

[0072] In many embodiments, the multiple pulses 820 affect the tissue location 830 with a duration between pulses that is less than the tissue relaxation time of the elastic deformation of the tissue to remove the tissue. In many embodiments, the first tissue to be removed has a first relaxation time that is longer than the time between pulses, and the second tissue to be prevented from being removed has a second tissue relaxation time that is shorter than the time between pulses to prevent removal of the second tissue.

[0073] As tissue is removed toward the final desired treatment profile, the size of the fluid flame may decrease substantially near the distal tip of the flame such that the size of the pulsating fluid flame affecting the ablated profile is substantially decreased and tissue removal is substantially reduced.

[0074] Based on the teachings described herein, one of ordinary skill in the art can determine the scanning movement of the carrier 382 and nozzle to ablate tissue to a target profile using the fluid flame described herein.

[0075] FIG. 8 shows a bag covering the fluid flow. The fluid flow may comprise a columnar flow or a diverging flow as described herein. In many embodiments, the bag is placed over the fluid flow comprising a pulsed flow to provide a water hammer effect. The bag may be made of one or more of many materials and may include, for example, an elastomer. The interior of the bag may be connected to the carrier 382 and the exterior of the bag may be connected to a working channel to remove material. The bag has the advantage of protecting the tissue from high fluid flow rates and may also provide an even pressure. The fragmented tissue may be collected through passive or active means, for example, through an outer collection tube or working channel.

[0076] 9A and 9B show variations in jet angle, according to an embodiment. The fluid jet angle and the laser beam can be fixed at different angles to achieve cutting and coagulation. One or more of cutting or coagulation can be directed, for example, to a single location or multiple locations. Angling can help target tissue near an expandable anchor, such as a balloon, or reduce the risk of accidental contact with unintended tissue. The jet angle can be varied in one or more of many ways. For example, multiple carriers 730 can be provided, each of which may comprise a carrier 382 having structures and components for treatment as described herein. Each of the multiple carriers 730 can provide a different fluid flow angle. For example, a first carrier can provide a first angle 732. A second carrier can provide a second jet along a second angle 734, and a third carrier can provide a third angle 736 as shown. The multiple probes may comprise a set of probes, e.g., three or more probes, each configured to direct one or more of the jet angle or the laser beam at an angle. For example, a first angle 732 can extend substantially perpendicular to the axis of elongation, and a third angle 736 can be directed toward the distal end of the probe to ablate interior tissue, e.g., tissue of the prostate.

[0077] In many embodiments, multiple probes can be provided, with one or more jets exiting the device axially to target tissue directly distal to the device.

[0078] FIG. 10 illustrates morcellation, according to an embodiment. In many embodiments, morcellation can be accomplished simultaneously with resection using structural features such as blades on the probe or spine. If integrated into the probe, morcellation can be automatically driven by movement of the probe. Vacuum suction can be used together with or independently of physical morcellation to increase collection flow. A combination of physical morcellation with, for example, an auger structure and vacuum can be utilized to regulate intraorgan pressure.

[0079] The carrier 382 can extend to a distal end portion having one or more jets as described herein. Morcellation features can be provided proximally with respect to the jets, which may be contained within the working channel, for example with an auger shaped structure to remove tissue.

[0080] FIG. 11A shows a single tube design, according to an embodiment. The single tube design may include a fluid delivery element, such as an orifice jewel 762. The variable bend 760 allows the radius to bend, for example, when the carrier 382 is advanced within the working channel. A fluid is coupled to an orifice on the end of the carrier 382. The fluid may include a liquid or gas, and the orifice on the distal end may be configured in one or more of many ways, as described herein. FIGS. 11B and 11C show a single tube design, according to an embodiment. A fluid, such as a liquid or gas, may be used in conjunction with a laser, as described herein. The laser may emit electromagnetic energy that is transmitted along an energy conduit 351, such as an optical fiber, as described herein. The variable bend 760 may be provided near a fluid delivery element, such as an orifice jewel 762 on the distal end. The optical fiber may be aligned with a structure as shown in FIG. 11C. For example, a fiber guide may be used to locate the optical fiber coaxially with the orifice of the fluid jet.

[0081] The single tube design according to the embodiment of Figures 11A, 11B, and 11C can provide many advantages. For example, package size and complexity can be significantly reduced when utilizing a single tube design. For example, internal laminar flow characteristics can be improved with a single tube design because the fluid path can be more continuous than other designs. The orifice jewel can be swaged in place or a small cover can be laser welded to hold the jewel. Fiber optic integration can be achieved through the use of internal fiber alignment structures. The bend angle and radius can be varied to allow for alternative tissue targeting or manufacturing. Multiple jets can be employed to balance the jet reaction course and cut more than one location at the same time. For example, opposing jets can be used. Additional jets can be added to, for example, power the rotational motion of the catheter.

[0082] The small package size can allow implementation in the form of a small catheter, which can enable use with commercially available rigid and flexible introducers and endoscopes of the prior art. The distal tip shape can be pre-formed with a given bend angle to access the tissue volume.

[0083] FIG. 12 shows tissue ablation and depth control according to an embodiment. A live patient ultrasound image is shown. FIG. 13 shows a visible fluid flame in saline. The visible fluid flame in saline corresponds to the entrainment region of the jet as described herein. The visibility of the entrainment region fluid flame is provided with cavitation of small bubbles that may generate optical or acoustic scattering to make the entrainment region fluid flame visible, for example, with ultrasound or optical imaging. The benefit of the visible entrainment region may be for the physician to visualize the distance of treatment and compare this distance with ultrasound. FIG. 13 shows a visible entrainment region at 11 millimeters, the same size as shown in FIG. 12. The substantial similarity of the entrainment region distance corresponds to the distance of tissue ablation and removal. This experimental result showing the visualization of the entrainment region may provide a safer treatment. By way of example only, the flow parameters used with the images shown in FIGS. 12 and 13 include a flow rate of about 130 millimeters / min and a nozzle back pressure of about 2700 psi. A configuration of nozzles on the carrier comprises a first liquid that is emitted with a diverging flow as described herein into a second fluid to provide a diverging flow, the second fluid including a liquid.

[0084] When treating a patient, a physician can use live patient ultrasound, for example, transrectal ultrasound (hereafter "TRUS") as described herein. The physician can perform an ultrasound examination from the probe tip in the entrainment region. This can be used to determine appropriate parameters to treat the patient. For example, the physician can adjust the pressure to limit the depth of penetration of the probe tip so that the probe tip does not release energy that would cause cutting outside of the organ, for example beyond the capsule of the organ, such as the capsule of the prostate. The image in FIG. 12 shows a structure corresponding to the expandable balloon on the left side of the image, with the arrow indicating the 11 millimeter dimension. FIG. 13 is an optical image showing a similar distance of the entrainment region. The sweeping motion of the flow shown in FIG. 12 can be used to adjust the treatment contained within the prostate.

[0085] 14 illustrates tissue ablation depth control, according to an embodiment. A live patient ultrasound from a patient similar to FIG. 13, but with increased backflow pressure to the nozzle, is shown in FIG.

[0086] FIG. 15 shows optical images of a fluid flame in saline showing the entrainment region with different pressures. The pressure flow parameters of FIGS. 14 and 15 include an approximate flow rate of 205 millimeters / minute and a nozzle back pressure of about 5760 psi. The corresponding tissue ablation depth is about 16 millimeters. A live patient ultrasound image shows a 16 millimeter entrainment region similar to the entrainment region seen optically. The sweeping motion of the probe and the fluid flow emitted from the probe as seen on the left side of the image can be used to set the flow parameters and pressures to safely treat the patient with an ultrasound image of the entrainment region.

[0087] One skilled in the art can use one or more of nozzle pressure, cutting depth, and flow rate to ablate tissue to a predetermined profile and volume, as described herein.

[0088] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will be apparent to those skilled in the art without departing from the scope of the present disclosure. It is understood that various alternatives to the embodiments of the present disclosure described herein may be adopted without departing from the scope of the present invention. Accordingly, the scope of the present invention is to be defined only by the appended claims and their equivalents.

Claims

1. An apparatus for removing at least a first portion of a patient's prostate, said at least a first portion of the prostate comprising an inner layer of prostatic tissue, and a second portion of the prostate comprising a capsule surrounding the inner layer of prostatic tissue; The apparatus comprises, at least in part, a probe (310) for advancing into the patient, the probe (310) configured to provide a water jet for ablating the patient's urethra at a first location and a second location, the water jet being projected between an inner layer of the prostate tissue and the capsule to separate the inner layer of the prostate tissue from the capsule, the separation of the inner layer of the prostate tissue from the capsule removing the at least a first portion of the prostate while preventing ablation of the capsule and blood vessels; the apparatus is configured to provide the water jet with a visible entrainment region of cavitation, and at least one of a flow rate and a pressure of liquid through the probe (310) is adjustable to adjust the length of the visible entrainment region; the device is adjustable to reduce a distance from an orifice to a tip of the visible entrainment region after severing the urethra; 11. An apparatus configured to image the visible entrainment region of the water jet, the apparatus being adjustable to adjust the length of the visible entrainment region based on the captured image of the visible entrainment region.

2. The device of claim 1, wherein the probe (310) is configured to be advanced into the patient using one or more of open surgical access, percutaneous access, or urethral access.

3. The device of claim 1, wherein the probe is configured to provide the water jet to a first location located near the bladder neck of the urethra and to a second location located near the verumontanum and from the verumontanum toward the bladder neck.

4. The apparatus of claim 1, wherein the probe (310) is configured to resect the urethra using multiple resections extending between the first location and the second location, the multiple resections extending from the urethra to the capsule.

5. The apparatus of claim 1, wherein the water jet includes a diverging flow.

6. The device described in claim 1, wherein the energy of the water jet is adjustable based on the acquired image of the entrained region of the water jet when the probe is inserted, at least partially, into the urethra.

7. The device described in claim 1, wherein the water jet is adjustable to a first amount of energy for resecting the urethra at the first location and the second location, and is adjustable to a second amount of energy for separating an inner layer of the prostate tissue from the capsule.

8. The apparatus of claim 1, wherein the probe comprises a first probe having a first orifice for providing the water jet to resect the urethra, and a second probe having a second orifice for providing the water jet to separate an inner layer of the prostate tissue from the capsule.

9. The apparatus of claim 8, wherein the probe (310) is configured to advance into a natural opening of the urethra to access the urethra, the probe is configured to resect the urethra at the first location and the second location using the first probe having the water jet extending to a side of the first probe to resect the urethra, and the second probe is configured to separate an inner layer of the prostate tissue from the capsule using the second probe having the water jet extending from an end of the second probe at a different angle than the first probe.

10. The device of claim 1, wherein the probe includes a sealed conduit that enables sheath ports to be used to transmit various fluid flows or pressures within or parallel to the working channel (465).

11. The device of claim 1, further comprising a percutaneous access port (456) for receiving the probe and endoscope.

12. The apparatus of claim 1, further comprising an endoscope for viewing the water jet.

13. The probe comprises a carrier tube (380) and a carrier (382), or The apparatus further comprises a bag for receiving the water jet.

2. The apparatus of claim 1.

Images