Patent Description:
Proper aseptic technique is one of the most fundamental and essential principles of infection control in the clinical and surgical setting. Creating and maintaining a sterile field is an essential component of aseptic technique. A sterile field is an area created by placing sterile surgical drapes around the patient's surgical site and on a stand that will hold sterile instruments and other items needed during treatment. A healthcare worker dons proper sterile surgical attire to enter the sterile field. Only sterile objects and personnel may be allowed within the sterile field. When a sterile field is created around a procedure site, items below the level of the draped client, such as items on the floor, are outside the sterile field and are not sterile. Only sterile items are free of potential infectious agents, and once a sterile object comes in contact with a non-sterile object, such as equipment, surfaces, or a person, outside of the sterile field, that object is no longer sterile. For example, if a healthcare worker touches a piece of equipment outside the sterile field with a gloved hand, that hand is no longer sterile and thus is no longer aloud within the sterile field.

Laser energy is used in a wide variety of medical procedures, including urology, neurology, otorhinolaryngology, ophthalmology, gastroenterology, cardiology, and gynecology. Various procedures, and even different portions of the same procedure, often require different levels and intensities of laser energy, which are delivered to cauterize, ablate, break-up, or otherwise treat tissue or other material in a patient. Generally, a user may control and/or modify the settings for the laser energy by inputting or adjusting the settings on a hand-based control module through buttons, dials, or a graphical user interface having a touch screen. However, in a surgical setting, the user usually is holding at least one medical device in his or her hands and may not be within arm's reach of the control module, which may increase the time and/or the number of medical professionals required during the procedure. Moreover, touching components outside of the sterile field (e.g., the control module) while also performing the procedure introduces sterilization and cleanliness issues. The chances of user error are also increased, further complicating and prolonging the procedure and exposing the patient to greater risk.

The laser energy is often generated at a control module that may house one or more laser components, where the laser energy propagates from the control module to a distal point, which may be located within a patient vasculature along one or more optical fibers. For example, a delivery fiber optically couple to the control module, receive the generated laser energy and enable the laser energy to propagate along the delivery fiber, which may be insertable into the patient vasculature, for example, within a working channel (lumen) of a catheter. The delivery fiber may be several meters long (e.g., <NUM>, <NUM>, <NUM>, etc., meters) as the placement of the control module relative to the operating table may vary. Thus, a portion of the delivery fiber routine contacts the ground and may lie in the walking paths of nurses, doctors or other medical staff present in the operating room. As a delivery fiber may be quite small (e.g., similar in size or smaller than a hair), it may be difficult to see, especially when the operating room lights are dimmed. This creates a dangerous environment when the delivery fiber contacts the ground in the walking paths of medical professionals as the delivery fiber may serve as a tripping hazard while simultaneously enabling propagation of laser energy along its length. <CIT> discloses an optical fiber surrounded by a cladding. The optical fiber comprises a plurality of cores (e.g., five cores). A single spiral channel is formed in the cladding of the optical fiber by selective chemical etching, and this extends from the central core, in close proximity the other the four cores, to the outer periphery of the cladding. Channels may be formed in the optical fiber cores by selective etching, e.g. to create a P-doped region of the core.

Systems, devices and methods disclosed herein may help overcome some of the disadvantageous and risks described above at least by providing an improved delivery fiber.

As claimed in claim <NUM>, there is provided an optical fiber cable, comprising an outer jacket, and a plurality of cores including a first core and a second core, wherein a plurality of channels extend outwardly from the second core toward the outer jacket, wherein the outer jacket is comprised of a material doped with a photoluminescent material configured to absorb energy from light propagating along the second core causing photoluminescence. The optical fiber cable further comprises a first cladding layer surrounding the first core and a second cladding layer surrounding the second core and the plurality of channels. The first core is configured for propagation of a first laser beam, where the first laser beam may a wavelength of substantially <NUM> nanometers. The second core and the plurality of channels are configured for propagation of a second laser beam, where the second laser beam has a wavelength of within the range of <NUM> - <NUM> nanometers including in some embodiments, substantially <NUM> nanometers and in other embodiments, substantially <NUM> nanometers. Further, the second laser beam may operate at a power level within the range of <NUM>-<NUM> Watts. The optical fiber cable also include a buffering layer disposed between at least cladding surrounding the first core and the outer jacket.

Also claimed herein is a system according to claim <NUM>.

The system may include a first operator interface operatively coupled with the first control module, the first operator interface configured to define a plurality of operating parameters of the first medical instrument, and selectively activate and deactivate the first medical instrument in accordance with providing the medical treatment. The system may include a second medical instrument comprising a second control module, a second patient interface member coupled with the second control module, the patient interface member comprising a distal end configured to engage the patient body and a handle attached to the patient interface member at proximal end of the patient interface member, where the handle is configured to be grasped by a hand of the operator, manipulation of the handle causes operations of the distal end, and the handle comprises a second operator interface, the second operator interface configured to define a subset of the plurality of operating parameters of the second medical instrument.

When in use, the optical fiber cable is coupled with patient interface member. The second medical instrument may be an endoscope or a ureteroscope. Additionally, the first operator interface may include a graphical user interface configured for defining the plurality of operating parameter and/or a foot pedal interface configured for the selective activation and deactivation of the first medical instrument.

These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

Embodiments of the disclosure are illustrated by way of example and not by way of limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which:.

The directional terms "proximal" and "distal" are used herein to refer to opposite locations on a medical device. The proximal end of the device is defined as the end of the device closest to the end-user when the device is in use by the end-user. The distal end is the end opposite the proximal end, along the longitudinal direction of the device, or the end furthest from the end-user.

Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.

<FIG> illustrates a current embodiment of a medical system <NUM> shown within a medical treatment environment. An operator <NUM> (e.g., a doctor) is shown performing an invasive treatment on a patient <NUM> within a sterile field <NUM>. The system <NUM> includes two separate medical instruments (or instrument systems as each may include a plurality of components), i.e., a first medical instrument system <NUM> and a second medical instrument system <NUM>. The treatment is such that simultaneous operation of the two medical instruments enhances the outcome of the treatment. In the illustrated current embodiment, the first medical instrument <NUM> is a urological surgery laser instrument (hereinafter referred to as the laser system <NUM>) and the second medical instrument system <NUM> is a ureteroscope system (hereinafter referred to as the ureteroscope system <NUM>).

The laser system <NUM> includes a laser control module <NUM> operatively coupled with a flexible laser shaft <NUM> (delivery fiber cable, or delivery fiber). The control module <NUM> includes a graphical user interface (GUI) <NUM> via which the operator <NUM> or an assistant may define a plurality of operating parameters of the laser system <NUM>. Additionally, the control module <NUM> includes logic <NUM> described below as well as one or more light sources <NUM> (e.g., lasers such as solid-state lasers, Ho:YAG lasers, fiber lasers, etc.) ("lasers <NUM>").

The delivery fiber <NUM> includes one or more cores (e.g., glass or plastic) along which laser light propagates from the lasers <NUM>, a cladding that surrounds each core where the cladding is formed of one or more layers of materials having a lower refractive index than the glass or plastic of the cores, an optional strengthening layer (e.g., formed of a heat-resistant, synthetic such as KEVLAR®) and an outer jacket (e.g., comprised of one or more of polyethylene, polyvinyl chloride, polyvinyl difluoride, low smoke zero halogen, etc.). The delivery fiber <NUM> may be a traditional delivery fiber cable where laser light propagating along the core(s) is contained within the core by the surrounding layers (e.g., cladding, strengthening layer, outer jacket). During operation of the instrument <NUM>, the lasers <NUM> are activated to turn "on" the laser beam and deactivated to turn "off" the laser beam in accordance with actuation of the pedals <NUM>, <NUM> of the pedal interface <NUM>, discussed below.

The laser system <NUM> includes a foot pedal interface <NUM> interface including a left foot pedal <NUM>, a right foot pedal <NUM> and a state button <NUM>. The foot pedal interface <NUM> is coupled with the control module <NUM> via a foot pedal connection wire <NUM>. As illustrated in <FIG>, the laser control module <NUM> and the foot pedal interface <NUM> are disposed outside of the sterile field <NUM>. The delivery fiber <NUM> extends across a barrier of the sterile field <NUM>. Additionally, a portion of the delivery fiber <NUM> is disposed on the ground near the feet of the operator <NUM>. In certain embodiments, the delivery fiber <NUM> may be coiled and act as a tripping hazard to the operator <NUM> and/or other medical professions also in the operating space. For example, a nurse may need to stand proximate the operating table between the table on which the system <NUM> and <NUM> are located and the operating table to attend to the patient <NUM>. As a result, the delivery fiber <NUM> as shown may act as a tripping hazard to the nurse as the nurse may have a difficult time seeing the delivery fiber <NUM> due to its size (e.g., small diameter).

The control module <NUM> includes logic <NUM> as described in relation to a state diagram shown in Table <NUM> below. The laser system <NUM> may generally be disposed in an active state and a standby state. Pressing the state button <NUM> toggles the laser system <NUM> between the active state and the standby state. The left and right foot pedals <NUM>, <NUM> are disabled when the laser system <NUM> is disposed in the standby state. When the laser system <NUM> is disposed in the active state, pressing the left foot pedal fires the lasers <NUM> in accordance with a left-pedal set of parameter settings, and pressing the right foot pedal fires the lasers <NUM> in accordance with a right-pedal set of parameter settings.

With further reference to the <FIG>, the ureteroscope system <NUM> includes ureteroscope control module <NUM> operatively coupled with an elongate flexible shaft <NUM> configured for insertion within a urinary tract of the patient <NUM>. The shaft <NUM> includes a camera (not shown) at a distal end of the shaft <NUM>. During operation, images acquired by the camera are rendered on a display <NUM> coupled with the ureteroscope control module <NUM>. A working channel <NUM> extends along the shaft <NUM>, and an access port <NUM> provides access to the working channel <NUM> at a proximal end of the shaft <NUM>.

A handle <NUM> is coupled to the shaft <NUM> at the proximal end of the shaft <NUM>. The handle <NUM> is configured for manipulation of the shaft <NUM> during use. The handle <NUM> includes a steering actuator <NUM> operatively coupled with an articulating distal portion (not shown) of the shaft <NUM> so that manipulation of the actuator <NUM> articulates the distal portion of the shaft <NUM>. A wire <NUM> couples the handle <NUM> with the ureteroscope control module <NUM>. As shown in <FIG>, the ureteroscope control module <NUM> and the display <NUM> are disposed outside of the sterile field <NUM>. The handle <NUM> and shaft <NUM> are disposed within the sterile field and as such, the wire <NUM> extends across the barrier of the sterile field <NUM>. As shown in <FIG>, an upper portion of the operator <NUM> including the hands <NUM> are disposed within the sterile field <NUM>, and a lower portion of the operator <NUM> include the feet are disposed outside the sterile field <NUM>.

During the treatment, the flexible shaft <NUM> of the ureteroscope system <NUM> is inserted into the urinary tract of the patient <NUM> to a treatment location. The flexible delivery fiber <NUM> is inserted into the working channel <NUM> of the shaft <NUM> via the access port <NUM>. The ureteroscope control module <NUM> renders images on the display <NUM> as acquired via the camera at the distal end of the shaft <NUM>. The images show tissue and other objects (e.g., a kidney stone) at the treatment location. The operator <NUM> performs the treatment via operation of the laser system <NUM> while viewing the images acquired and displayed by the ureteroscope system <NUM>.

A treatment procedure may typically include positioning the working distal end of the delivery fiber <NUM> at a desired location as verified by the acquired images. Manipulation of the delivery fiber <NUM> is typically preformed via manipulation of the shaft <NUM> of the ureteroscope system <NUM>. More specifically, the operator <NUM> grasps and manipulates the handle <NUM> to position the distal end of the shaft <NUM> thereby positioning the distal end the delivery fiber <NUM> which is disposed within the working channel <NUM>. The operator <NUM> may adjust the insertion depth of the shaft <NUM> and may also adjust a rotational position of the shaft <NUM>. The operator <NUM> may also manipulate the steering actuator <NUM> to articulate the distal portion of the shaft <NUM>. Articulation of the distal portion of the shaft <NUM> may effectively point the distal end of the laser system <NUM> toward a desired object for ablation or surgery.

After establishing the desired position and orientation of the distal end of the laser system <NUM>, the operator <NUM> may press the left foot pedal <NUM> or right foot pedal <NUM> to fire the lasers <NUM> in accordance with the treatment. In some instances, it may be desirable to adjust one or more operating parameters of the laser system <NUM> after initiation of the treatment. In such instances, touching the GUI <NUM> may be necessary by the operator <NUM> or an assistant. Standard aseptic technique requires the upper portion of the operator (i.e., the portion within the sterile field <NUM>) to remain within the sterile field <NUM> through the duration of the treatment. As such, typical practice includes instructing an assistant to make the parameter adjustments after which the operator <NUM> may verify the parameter adjustments by viewing the GUI <NUM>.

<FIG> illustrates an embodiment of an improved medical system within a medical treatment environment, in accordance with some embodiments. Numerous aspects and components of <FIG> remain unchanged from the illustration of <FIG>. However, the medical system <NUM> includes the laser system <NUM> and the ureteroscope system <NUM>. The laser system <NUM> differs from the system <NUM> of <FIG> with respect at least to the delivery fiber <NUM> which is improved compared to the delivery fiber <NUM>.

The laser system <NUM> includes the laser control module <NUM> operatively coupled with a flexible laser shaft <NUM> (delivery fiber cable, or delivery fiber). The delivery fiber <NUM> includes at least one or more cores (e.g., glass or plastic) along which laser light propagates from the lasers <NUM>, a cladding that surrounds each core where the cladding is formed of one or more layers of materials having a lower refractive index than the glass or plastic of the cores, an optional strengthening layer (e.g., formed of a heat-resistant, synthetic such as KEVLAR®) and an outer jacket. Additionally, the delivery fiber <NUM> includes a plurality of channels that extend outwardly (outwardly-extending channels, or channels) from the core to the interior of the outer jacket, where the outwardly-extending channels enable laser light to propagate distally from the core toward the interior of the outer jacket.

The outer jacket may be comprised of one or more of polymer, polyethylene, polyvinyl chloride, polyvinyl difluoride, low smoke zero halogen, etc., and doped with a photoluminescent material configured to absorb and stores photons (particles of light) from the laser beam propagating along the corresponding. The stored energy is released as visible light creating a "glowing" impression. As a result, the delivery fiber <NUM> provides a technological improvement over the delivery fiber <NUM> as the delivery fiber <NUM> creates a glowing impression that is visible to the operator <NUM> and any other medical professions in the operating room. This reduces the likelihood that one will trip over or step on the delivery fiber <NUM>.

In some embodiments, as illustrated in <FIG> and discussed below, a delivery fiber <NUM> may include two cores: a first core configured for propagating a first laser beam (e.g., a working beam), and a second core configured for propagating a second laser beam (e.g., an aiming beam). In some embodiments, the aiming beam may be "visible" to the human eye having a wavelength within the range of <NUM> nanometers (nm) to <NUM>. In some particular embodiments, the aiming beam may be visible as "green" having a wavelength of approximately <NUM>. In other embodiments, the aiming beam may be visible as "red" having a wavelength of approximately <NUM>. In some embodiments, the working beam may be invisible to the human eye having a wavelength of <NUM>, which matches the water-absorption peak in the mid-infrared band of electromagnetic energy.

<FIG> illustrates a first embodiment of portions of the ureteroscope system of the medical system of <FIG> having the fiber delivery line disposed therein, in accordance with some embodiments. In particular, <FIG> illustrates the delivery fiber <NUM> being deployed and partially disposed within the shaft <NUM>, where the delivery fiber <NUM> may enter a working channel <NUM> (<FIG>) and advance therethrough. Additionally, <FIG> illustrates the outer jacket of the delivery fiber <NUM> illuminating visible light.

<FIG> is a detailed illustration of a distal portion <NUM> of the shaft of the ureteroscope system as seen in <FIG>, in accordance with some embodiments. The distal portion of the shaft <NUM> may include a plurality of channels <NUM>, <NUM>, <NUM>, <NUM>. In various embodiments, the channels <NUM>, <NUM>, <NUM> may take on different functionalities based on the make and model of the shaft <NUM>. For example, some embodiments of the shaft <NUM> may deploy an optical camera in the channel <NUM>, deploy a light source in each of the channels <NUM>, <NUM>, where channel <NUM> is configured as a working channel in fluid communication with the access port <NUM>. In other embodiments, the shaft <NUM> may include a plurality of working channels that may be utilized for suction or irrigation, for example.

<FIG> also illustrates that the laser beams 312A-312B propagating distally from the distal tip <NUM> of the delivery fiber <NUM>. In the embodiment shown, the delivery fiber <NUM> includes two cores, a first core configured for propagating a first laser beam 312A (e.g., a working beam), and a second core configured for propagating a second laser beam 312B (e.g., an aiming beam).

<FIG> illustrate views of an embodiment of the distal end of the fiber delivery line of <FIG> in operation, in accordance with some embodiments. As seen in the embodiment of <FIG>, a first core may be configured to propagate the working beam 312A while a second core may be configured to propagate the aiming beam 312B.

<FIG> is a first cross-sectional view of an embodiment of the delivery fiber along the line 5A-5A of <FIG>, in accordance with some embodiments. The cross-sectional view of the delivery fiber <NUM> illustrates an embodiment that includes multiple cores, a first core <NUM> configured to propagate the working beam 312A and a second core configured to propagate the aiming beam 312B. <FIG> illustrates that the first core <NUM> is completely surrounded by a cladding <NUM>, which is further surrounded by a coating or buffering layer <NUM>. Additionally, the second core <NUM> is shown to be partially surrounded by the cladding <NUM>, which is in turn also surrounded by the coating or buffering layer <NUM>. An outer jacket <NUM> surrounds the coating or buffering layer <NUM>.

Additionally, <FIG> illustrates the plurality of channels <NUM><NUM>-<NUM><NUM> (although an alternative number of channels may be utilized in various embodiments) that extend outwardly from the core <NUM>, where each channel is also surrounded by cladding <NUM>. As a result, a small amount of the aiming beam 312B propagates outwardly from the core <NUM> toward the interior of the outer jacket <NUM>, which absorbs some of the energy of the aiming beam 312B (e.g., photons) causing the outer jacket <NUM> to release visible light (e.g., "glow"). <FIG> is a second cross-sectional view of the embodiment of the fiber delivery of <FIG> along the line 5B-5B of <FIG>, in accordance with some embodiments. <FIG> illustrates the aiming beam 312B propagating along the channels <NUM><NUM>-<NUM><NUM> (where channels <NUM><NUM> are not visible in this cross-sectional view).

Notably, at least in some embodiments, the visible light <NUM> being emitted from the outer jacket <NUM> is based on interaction of the aiming beam 312B with the outer jacket <NUM> causing the photoluminescence. Thus, in the embodiment illustrated in <FIG>, the aiming beam may be visible to a human eye (e.g., having a wavelength within the range of <NUM> nanometers (nm) to <NUM>), and in some particular embodiments, the aiming beam may be visible as "green" having a wavelength of approximately <NUM> or as "red" having a wavelength of approximately <NUM>. In such embodiments, the working beam 312A may be invisible to the human eye (e.g., having a wavelength of approximately <NUM>, or more broadly within a threshold range of <NUM>, such as +/-<NUM>). In some embodiments, the aiming beam may operate at a very low level of power (e.g., within the range of <NUM>-<NUM> Watts (W), or substantially <NUM> W).

Such embodiments are distinct from merely providing a high-powered working beam having a wavelength that is visible to the human eye, where the working beam is so powerful that it is visible through the cladding, optional coating or buffering layer and outer jacket (e.g., a working beam operating at <NUM> W with a wavelength of, for example, <NUM>).

Claim 1:
An optical fiber cable, comprising:
an outer jacket (<NUM>); and
a plurality of cores including a first core (<NUM>) and a second core, wherein a plurality of channels extend outwardly from the second core toward the outer jacket, wherein the outer jacket is comprised of a material doped with a photoluminescent material configured to absorb energy from light propagating along the second core causing photoluminescence.