Patent Description:
Certain medical conditions, such as conditions of the prostate, may be treated by ablation, including by vapor ablation. Such ablation may be performed using a device having a sheath that is inserted into a body lumen or otherwise into a body of a patient. In ablation procedures, visualization of the area being treated may assist in performing the procedure effectively. A user may also desire to utilize tools or deliver fluids during a procedure. However, components such as treatment elements (e.g., needles), visualization components, and/or working channels may increase a diameter of the sheath or overall device, thereby resulting in increased discomfort or recovery time for the patient.

The systems, devices, and methods of the current disclosure may rectify some of the deficiencies described above, and/or address other aspects of the prior art.

Document <CIT> describes systems and methods for prostate treatment. A vapor delivery needle is provided that may include any of a number of features. One feature of the energy delivery probe is that it can apply condensable vapor energy to tissue, such as a prostrate, to shrink, damage, denaturate the prostate. In some embodiments, the vapor delivery needle can be advanced a predetermined distance into the prostate by an actuation mechanism. The actuation mechanism can comprise, for example, a spring, or at least one magnet.

Document <CIT> describes a vapor delivery system and method that is adapted for treating prostate tissue. The vapor delivery system includes a vapor delivery needle configured to deliver condensable vapor energy to tissue. In one method, the vapor delivery system is advanced transurethrally into the patient to access the prostate tissue. The vapor delivery system includes a generator unit and an inductive heating system to produce a high quality vapor for delivery to tissue. Methods of use are also provided.

In an example, a device for vapor ablation comprises a sheath extending from a proximal end to a distal portion. The sheath includes a lumen terminating distally at a lumen opening. The device further comprises a vapor delivery member received in the lumen. The vapor delivery member includes a channel configured to receive vapor and at least one aperture configured to deliver the vapor to a body tissue. The device further comprises an electrical component having a chip. The chip is disposed proximate to the distal lumen opening.

Any of the devices disclosed herein may have any of the following features. The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor. The sheath includes a working channel extending from the proximal end and terminating distally at a working channel opening. The electrical component is disposed radially between the working channel opening and the distal lumen opening. The working channel may have two convex sides, one concave side, and one straight side. The electrical component may have a face directed distally. The member may be configured to be transitioned from a first configuration to a second configuration. In the first configuration, the member may not extend out of the distal portion. In the second configuration, the member may extend out of an opening on a radially outer surface of the distal portion. When in the second configuration, a line extending normally from a surface of the electronic component may be transverse to the member. The electronic component may be disposed distally of the distal lumen opening. The sheath may include a plurality of working channels extending from the proximal end to the distal portion. The electrical component may be a first electrical component and the chip is a first chip. The device may further comprise a second electrical component having a second chip. The second chip may be disposed at the distal portion. Each of the first electrical component and the second electrical component may have a face directed distally. The sheath may have a substantially pear-shaped cross-section. The chip may be configured for spectral analysis.

In another example, a device for vapor ablation comprises a sheath extending from a proximal end to a distal portion and a lumen extending from the proximal end to a lumen opening at the distal portion. A vapor delivery member is disposed within the lumen. The device further a working channel extending from the proximal end to a working channel opening at the distal portion and an electrical component having a chip. The chip is disposed proximate to the lumen opening.

Any of the devices disclosed herein may have any of the following features. The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor. The electrical component may face at least partially distally.

In still another example, a device for vapor ablation comprises a sheath extending from a proximal end to a distal portion and a lumen extending from the proximal end to a lumen opening at the distal portion. A vapor delivery member is disposed within the lumen. The device further comprises a working channel extending from the proximal end to a working channel opening at the distal portion and an electrical component disposed radially between the lumen opening and the working channel opening.

Any of the devices disclosed herein may have any of the following features. The electronic component may include at least one of a camera, an optical coherence tomography sensor, a spectrum analyzing sensor, or a force sensor.

As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," rather than "ideal. " As used herein, the term "proximal" means a direction closer to an operator and the term "distal" means a direction further from an operator. Although vapor ablation is referenced herein, such references should not be construed as limiting. The examples disclosed herein may also be used with other types of ablation mechanisms (e.g., cryoablation, RF ablation, or other types of ablation) or with other devices not relating to ablation.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and together with the description, serve to explain the principles of the disclosure.

A device for vapor ablation may include one or more electronic components including cameras, light sources, ultrasound sensors, or other sensors. Component(s) may be located near a distal tip of the device. The component(s) may be arranged so that the device has sufficient cross-sectional area available for a working channel. In one example, electronic component(s) may face at least partially distally. In another example, electronic component(s) may face at least partially proximally. Still further, in other examples, electronic component(s) may face at least partially radially inwardly or partially radially outwardly relative to a longitudinal axis of the distal tip. Electronic component(s) may face a combination of directions (e.g., partially distally/proximally and partially radially inwardly/outwardly. The examples described herein may be used in combination. For example, a device may have electronic components that face both distally and proximally.

<FIG> shows a cross-section of an exemplary distal assembly of an ablation device <NUM>. Ablation device <NUM> may include a shaft <NUM>, which may be insertable into a body lumen of a patient or otherwise into a body of a patient (e.g., through a tissue of a patient, such as via a transperineal route). Shaft <NUM> may have a distal tip <NUM>. Distal tip <NUM> may include a distal-most surface <NUM>. Distal-most surface <NUM> may have an atraumatic shape (e.g., a rounded, bulbous shape). Distal tip <NUM> and/or distal-most surface <NUM> may be made of any suitable material, including a plastic material, which may be transparent (e.g., acoustically transparent). Distal tip <NUM> may alternatively be made of metal, resin, Ultem®, polyurethane, or other materials, or a combination of materials.

Device <NUM> may include a needle lumen <NUM> that extends from a proximal end of sheath <NUM> (not shown) to a distal opening <NUM>. A needle <NUM> may be inserted into needle lumen <NUM>. Needle <NUM> may be a member having a central lumen or channel extending from a proximal end of needle <NUM> (not shown) toward a distal tip <NUM> of needle <NUM>, and a plurality of apertures <NUM> near distal tip <NUM>. The plurality of apertures <NUM> may be configured to communicate the contents of the central lumen or channel (e.g., vapor, steam) to surrounding tissue into which distal tip <NUM> is positioned, received, or otherwise inserted. For example, the central lumen or channel of needle <NUM> may be configured to receive vapor therein (e.g., via a vapor generator fluidly coupled to the proximal end of needle <NUM>) and to deliver the vapor to tissue via the apertures <NUM>. Needle <NUM> may be configured to have a first, insertion configuration, in which needle <NUM> is contained, received, or otherwise positioned within lumen <NUM> (e.g., such that no portion of distal tip <NUM> extends radially outwardly of distal tip <NUM>, relative to a longitudinal axis of distal tip <NUM>). Needle <NUM> may have a second, treatment configuration (<FIG>), in which distal tip <NUM> of needle <NUM> is extended out of distal opening <NUM> (e.g., and optionally, radially outwardly of distal tip <NUM>, relative to the longitudinal axis of distal tip <NUM>). In the treatment configuration, needle <NUM> may curve radially outward relative to the longitudinal axis of sheath <NUM>. Needle <NUM> may extend through a gap <NUM> in distal tip <NUM> and through of a radial surface opening <NUM>. In some aspects, distal tip <NUM> may include one or more surface features to guide needle <NUM> from the insertion configuration toward the treatment configuration. For example, one or more portions of distal tip <NUM> may be curved, slanted, or otherwise directed toward radial surface opening <NUM>, such that, during advancement (e.g., distal advancement) of needle <NUM> through lumen <NUM> and distal opening <NUM>, one or more portions (e.g., distal tip <NUM>) of needle <NUM> may impact or otherwise interface with the one or more portions of distal tip <NUM> such that continued advancement of needle <NUM> may cause needle <NUM> to bend, deflect, or otherwise be guided toward (and through) radial surface opening <NUM>. As will be described in further detail below, <FIG> show cross-sectional proximal-facing views of distal tip <NUM>, taken across cross-section A-A of <FIG>, with needle <NUM> extending out of distal opening <NUM>, according to a first and a second exemplary arrangement, respectively.

Distal tip <NUM> may also include one or more electronic components 30A, 30B, which, as shown in <FIG>, may face distally and/or radially outward in a direction toward radial surface opening <NUM>. A direction that a component 30A, 30B faces may include a direction in which a face of component 30A, 30B is directed. Although two electronic components 30A, 30B are shown in <FIG>, it will be appreciated that any number of electronic components may be used. A direction and positioning of electronic components 30A, 30b as shown in <FIG> is merely exemplary. Electronic components 30A, 30B may face any suitable direction and may be positioned in any suitable manner. Electronic components 30A, 30B may assist in navigation of needle <NUM>.

Electronic components 30A, 30B may utilize wafer-based chip technology. Chips of electronic components 30A, 30B may be located/disposed at or proximate to distal tip <NUM>. For example, electronic components 30A, 30B may include a camera, a light source, ultrasound sensor, a heat-electronic component, optical coherence tomography sensor, spectrum analyzing sensor, force sensor, infrared sensor (such as near infrared sensor), ultraviolet sensor, pressure sensor, temperature sensor, chemical sensor, accelerometer, force sensor, magnetoresistance sensor, tunnel magnetoresistance sensor, or other type of sensor or electronics. Electronic components 30A, 30B may facilitate real-time procedural analyses and efficiencies and may be used in conjunction with various algorithms. Electronic components 30A, 30B may be used for subsurface visualization, procedural feedback, mapping of tissue and/or tagging of tissue. Different or similar types of sensors may be used in combination with one another. Where multiple electronic components 30A, 30B are used, all electronic components 30A, 30B may be utilized at once, or different electronic components 30A, 30B may be active depending on a type of procedure, a stage of a procedure, the findings during a procedure, etc. Electronic components 30A, 30B may be flexible, rigid, or semi-flexible. Additionally, one or more wires (not shown) may electronically couple electronic components 30A, 30B to one or more actuators <NUM> positioned on a handle <NUM> of sheath <NUM>, as will be described in further detail below. For example, the one or more wires may extend proximally from electronic components 30A, 30B toward a proximal end of sheath <NUM> and may pass through a lumen in sheath <NUM> (e.g., other than a working channel <NUM> (described in further detail below) or the lumen <NUM>).

As shown particularly in <FIG>, electronic component 30A may include components such as camera <NUM> and light source <NUM>. Although camera <NUM> and light source <NUM> are given as exemplary elements of electronic component 30A, it will be appreciated that a wide variety of types of devices may be used. Electronic component 30A may have a distal surface, and a line extending normally from the surface may be transverse to needle <NUM> when needle <NUM> is in the second, treatment configuration.

Camera <NUM> may be oriented so as to allow a user to view needle <NUM> as it is being extended out of opening <NUM> and/or radial surface opening <NUM> (e.g., as shown in <FIG> and <FIG>). Camera <NUM> may include any appropriate elements, such as lenses, imagers, circuitry, etc. Camera <NUM> may be capable of performing spectral analyses and/or of analyzing types of light outside of the visual light spectrum. For example, camera <NUM> may include an RBG-Ir chip or module or a chip capable of infrared spectrum analysis, which may provide spectral analysis and information on temperature gradient during a treatment. More than one camera <NUM> may be used. For example, different types of cameras <NUM> may be used, or multiple of the same type of camera <NUM> may be used to provide different views of a procedure site. A single camera <NUM> may also include multiple chips, including multiple types of chips capable of performing multiple kinds of analysis.

Light source <NUM> may be, for example, one or more light emitting diode (LED) devices (which may include multiple colors of light), fiber device, a fiber optic bundle (FOB) device, or another type of lighting device (e.g., lighting an entirety of distal tip <NUM> to create diffused light). Light source <NUM> may be a single light source or may include multiple light sources. Light source <NUM> may provide varying spectra of light to facilitate analysis at a procedure site. Light source <NUM> may be integrated into a unified structure with camera <NUM>. Alternatively, light source <NUM> and camera <NUM> may be separate structures.

Light source <NUM> may be oriented in a same or similar direction to camera <NUM>, as shown in <FIG>. An orientation of light source <NUM> may facilitate visualization by camera <NUM>. Camera <NUM> and light source <NUM> may be aligned at an approximately equal distance from a central longitudinal axis of sheath <NUM>. Camera <NUM> and/or light source <NUM> may be positioned on a proximal side of gap <NUM> or elsewhere so that camera <NUM> and/or light source <NUM> are facing a medium (e.g., air) that is conducive to functions of camera <NUM> and/or light source <NUM>. Camera <NUM> and/or light source <NUM> may face gap <NUM> or another open area or may be encapsulated with an appropriate material, such as the material of distal tip <NUM>. For example, material of distal tip <NUM> may cover camera <NUM> and/or light source <NUM> and may provide light-guiding, deflecting, or other features. Camera <NUM> may be oriented so that opening <NUM> is in a direction toward a top of an image produced by camera <NUM> (and that may be shown on a display to a user), and radial surface opening <NUM> is in a direction toward a bottom of an image produced by camera <NUM>. A display shown to a user may be a hands-free system such as an augmented reality system. Camera <NUM> and/or light source <NUM> may be between (along a radial direction) opening <NUM> and radial surface opening <NUM>. Camera <NUM> and/or light source <NUM> may be closer to a central longitudinal axis of sheath <NUM> than is opening <NUM>.

As shown in <FIG>, <FIG>, electronic component 30B may include an ultrasound sensor <NUM>. Ultrasound sensor <NUM> may face any direction, including a direction that is at least partially radially outward. An area of sheath <NUM> surrounding ultrasound sensor <NUM> may be acoustically transparent so as to transmit signals from ultrasound sensor <NUM> or another type of sensor, such as those discussed above.

Sheath <NUM> may also include a working channel <NUM>. Working channel <NUM> may have a distal opening <NUM> (see <FIG>). Working channel <NUM> may be used to pass, for example, fluids or tools. Working channel <NUM> may be located (along a radial direction) between electronic component 30A and radial surface opening <NUM>. Working channel <NUM> may be located toward a bottom of an image produced by camera <NUM> and displayed to a user. Working channel <NUM> may have a shape that is complementary to a shape of sheath <NUM> and/or other components of device <NUM> including electronic components 30A, 30B. For example, a cross-sectional shape of working channel <NUM> (see <FIG>) may have a shape that has two convex curved sides, one concave curved side, and one flat side, collectively defining a lumen of working channel <NUM>. Electronic component 30A may be most proximate to a concave curved side of working channel <NUM>.

As shown in <FIG>, working channel <NUM> may be divided by a divider <NUM> so that two sub-channels are formed. The sub-channels may terminate in two openings, 42A and 42B. Working channel <NUM> may be divided along an entire length of working channel <NUM>. Alternatively, working channel <NUM> may only be divided along a portion (e.g., a distal portion, near openings 42A and 42B) of working channel <NUM>. Openings 42A and 42B (and sub-channels of working channel <NUM>) may have the same shape and/or size, as shown in <FIG>, or may have different shapes and/or sizes without departing from the scope of this disclosure. The sub-channels terminating in openings 42A and 42B may be used for the same purposes or for different purposes. For example, the sub-channel terminating in opening 42A may be used for one fluid, and the sub-channel terminating in opening 42B may be used for another fluid. Additionally or alternatively, the sub-channel terminating in opening 42A may be used for delivery of fluid source to a site in a subject's body, and the sub-channel terminating in opening 42B may be used for return of fluid from the subject's body (e.g., via suction). Additionally or alternatively, the sub-channels terminating in openings 42A and 42B may be used for different tools, or one of the sub-channels terminating in openings 42A and 42B may receive one or more tools, and the other may receive one or more fluids.

The configurations of working channel(s) <NUM> shown in <FIG>, <FIG> are merely exemplary. Working channel(s) <NUM> may have any appropriate shape or features and may be positioned in a variety of ways with respect to other components of distal tip <NUM>, such as electronic components 30A, 30B, and lumen <NUM>.

Electronic component 30B may be positioned between working channel(s) <NUM> and an outer surface of sheath <NUM>, as shown in <FIG>, <FIG>. It will be appreciated that a placement of electronic components 30A, 30B are merely exemplary, and that electronic components 30A, 30B may be placed in any suitable position. Although electronic components 30A, 30B are shown as distal-facing, it will also be appreciated that electronic components 30A, 30B may face in any direction.

As shown in <FIG>, a cross-section of sheath <NUM> may have an approximately pear-shaped outermost surface. However, such a shape is merely exemplary and any other shape may be utilized. For example, sheath <NUM> may have a rounded cross section, ovular cross section, or any other suitable shape. A size of sheath <NUM> may be varies so as to be tailored to a patient, a treatment being performed, etc. A largest dimension of a cross section of sheath <NUM> may be smaller than <NUM> French.

As shown in <FIG>, device <NUM> may have a handle <NUM> for gripping by a user during a procedure. Handle <NUM> may include mechanisms for controlling device <NUM>, such as controls for needle <NUM>. Handle <NUM> may also include an actuator <NUM>, which may be an image or video capture button. Actuator <NUM> may work in conjunction with one or more of electrical components 30A, 30B to capture current readings by electrical component(s) 30A, 30B. For example, actuator <NUM> may capture a still image or moving video from camera <NUM>. A position of actuator <NUM> shown in <FIG> is merely exemplary, and actuator <NUM> may be located in any suitable position, including on a separate generator or elsewhere on handle <NUM>.

<FIG> show another example ablation device <NUM>. <FIG> shows a partial cross-section of ablation device <NUM>. <FIG> shows a perspective view of ablation device <NUM>, with certain portions shown as being transparent. <FIG> shows another perspective view of ablation device <NUM> without transparency. Ablation device <NUM> may have any of the features of ablation device <NUM>, described above, with similar features being designated with similar reference numerals plus "<NUM>". Ablation device <NUM> may include a shaft <NUM>, which may be insertable into a body lumen of a patient or otherwise into a body of a patient (e.g., through a tissue of a patient, such as via a transperineal route). Shaft <NUM> may have a distal tip <NUM>. Distal tip <NUM> may include a distal-most surface <NUM>. Distal-most surface <NUM> may have an atraumatic shape (e.g., a rounded, bulbous shape). Distal tip <NUM> and/or distal-most surface <NUM> may be made of any suitable material, including a plastic material, which may be transparent. Distal tip <NUM> may alternatively be made of metal, resin, Ultem®, polyurethane, or other materials, or a combination of materials.

Device <NUM> may include a needle lumen <NUM> (see <FIG>) that extends from a proximal end of sheath <NUM> (not shown) to a distal opening <NUM>. A needle <NUM> (which may have any of the features of needle <NUM>) may be inserted into needle lumen <NUM>. Needle <NUM> may have a central lumen extending from a proximal end of needle toward a distal tip <NUM> of needle <NUM>, and a plurality of apertures <NUM> near the distal tip. The plurality of apertures <NUM> may be configured to communicate the contents of the central lumen or channel (e.g., vapor, steam) to surrounding tissue into which distal tip <NUM> is positioned, received, or otherwise inserted. For example, the central lumen or channel of needle <NUM> may be configured to receive vapor therein (e.g., via a vapor generator fluidly coupled to the proximal end of needle <NUM>) and to deliver the vapor to tissue via the apertures <NUM>. Needle <NUM> may be configured to have a first, insertion configuration, in which needle <NUM> is contained, received, or otherwise positioned within lumen <NUM> (e.g., such that no portion of distal tip <NUM> extends radially outwardly of distal tip <NUM>, relative to a longitudinal axis of distal tip <NUM>). Needle <NUM> may have a second, treatment configuration (<FIG>), in which distal tip <NUM> of needle <NUM> is extended out of distal opening <NUM> (e.g., and optionally, radially outwardly of distal tip <NUM>, relative to the longitudinal axis of distal tip <NUM>). In the treatment configuration, needle <NUM> may curve radially outward relative to the longitudinal axis of sheath <NUM>. Needle <NUM> may extend through a gap <NUM> in distal tip <NUM> and through of a radial surface opening <NUM>. In some aspects, distal tip <NUM> may include one or more surface features to guide needle <NUM> from the insertion configuration toward the treatment configuration. For example, one or more portions of distal tip <NUM> may be curved, slanted, or otherwise directed toward radial surface opening <NUM>, such that, during advancement (e.g., distal advancement) of needle <NUM> through lumen <NUM> and distal opening <NUM>, one or more portions (e.g., distal tip <NUM>) of needle <NUM> may impact or otherwise interface with the one or more portions of distal tip <NUM> such that continued advancement of needle <NUM> may cause needle <NUM> to bend, deflect, or otherwise be guided toward (and through) radial surface opening <NUM>.

Distal tip <NUM> may also include one or more electronic components <NUM>. Electronic components <NUM> may have any of the features of electronic components 30A, 30B, described above. Ablation device <NUM> may include electronic components <NUM> positioned as shown and described with respect to <FIG> and <FIG>, although electronic components <NUM> are not separately shown in <FIG>. As shown in <FIG>, electronic components <NUM> may alternatively or additionally be positioned in/on a surface of an atraumatic tip <NUM> that is distal to openings <NUM>, <NUM>, and/or gap <NUM>. Electronic components <NUM> may face proximally and may be angled in a radial direction toward opening <NUM>. Such positioning may enable electronic component <NUM> to have any of the functionality of electronic component <NUM>, as discussed above. Although <FIG> show one exemplary electronic component <NUM>, it will be appreciated that any number of electronic components <NUM> may be used. For example, electronic components <NUM> may also be positioned similarly to electronic components 30A, 30B of <FIG>, <FIG>.

Sheath <NUM> may also include a working channel <NUM> having a distal opening <NUM>. Working channel <NUM> may have any of the features of working channel <NUM> and may include multiple sub-channels (see, e.g., <FIG>). Positioning electronic components <NUM> in/on a surface of atraumatic tip <NUM> may further facilitate increasing a diameter of working channel <NUM>, as components need not be positioned near opening <NUM>.

Use of electronic components, such as components 30A, 30B, <NUM>, may facilitate aspects of ablation procedures. For example, if electronic component <NUM> or <NUM> has ultrasound or other types of imaging capability, electronic components <NUM>, 30A, and/or <NUM> may assist in positioning a needle such as needle <NUM>/<NUM>. Such functionality may be particularly useful where needle <NUM>/<NUM> is positionable at variable distances from openings <NUM>/<NUM> and <NUM>/<NUM>. Additionally, one or more wires (not shown) may electronically couple electronic component <NUM> to one or more actuators (not shown), which may have any features of actuator <NUM>, described above. For example, the one or more wires may extend proximally from electronic component <NUM> toward a proximal end of sheath <NUM> and may pass through a lumen in sheath <NUM> (e.g., other than working channel <NUM> or lumen <NUM>).

Claim 1:
A device (<NUM>; <NUM>) for vapor ablation, the device (<NUM>; <NUM>) comprising:
a sheath (<NUM>; <NUM>) extending from a proximal end to a distal portion, wherein the sheath (<NUM>; <NUM>) includes a lumen (<NUM>; <NUM>) terminating distally at a lumen opening (<NUM>; <NUM>);
a vapor delivery member (<NUM>; <NUM>) received in the lumen (<NUM>; <NUM>), wherein the vapor delivery member (<NUM>; <NUM>) includes a channel configured to receive vapor and at least one aperture (<NUM>; <NUM>) configured to deliver the vapor to a body tissue; and
an electrical component (30A, 30B; <NUM>) having a chip, wherein the chip is disposed proximate to the distal lumen opening (<NUM>; <NUM>),
wherein the sheath (<NUM>;<NUM>) includes a working channel (<NUM>; <NUM>) extending from the proximal end and terminating distally at a working channel opening (<NUM>; <NUM>), and wherein the electrical component (30A, 30B; <NUM>) is disposed radially between the working channel opening (<NUM>; <NUM>) and the lumen opening (<NUM>;<NUM>).