Patent Description:
Many surgical procedures and other conditions require the removal of debris from the lumen or cavity of a patient. For example, urologists may need to remove a kidney stone. Typically, in such a case, the surgeon will perform laser lithotripsy to break up the kidney stone into multiple fragments and remove the stone fragments with a basket device. This process can be time consuming due to the fact that the surgeon can only remove one fragment at a time. In contrast, a vacuum system would allow a surgeon to remove more than a single fragment or stone at a time. However, a clogged lumen obstructs a vacuum system's path of suction, which reduces efficiency of removing stones with such a system and can be dangerous for the patient because it can cause a rise in the patient's cavity pressure. Thus, the present design provides a new method of removing or preventing a clog within a lumen full of debris during vacuum suctioning by using vibration energy.

Document <CIT> describes a method of aspirating a vascular occlusion from a remote site. The method includes the steps of advancing a first elongate tubular body through a vascular access site and into a body vessel, advancing a second tubular body distally to extend beyond the first elongate tubular body to reach the remote site, and aspirating thrombus from the site into the lumen by applying pulsatile vacuum to the first elongate tubular body. The second tubular body has a lumen and a length that is shorter than the first elongate tubular body. The pulsatile application of vacuum may cause the distal tip of the second tubular body to open and close like a jaw, which facilitates reshaping the thrombus or biting or nibbling the thrombus material into strands or pieces to facilitate proximal withdrawal under negative pressure through the lumen of the second tubular body.

Document <CIT> describes an apparatus for removing biological material from a body. The apparatus comprises a hollow tubular elongate member, one end of which can engage biological material to be removed, a casing in which a portion of the tubular member is mounted for longitudinal sliding movement, a motor which is connected to the casing and has a rotatable drive shaft, means for coupling the rotation of the drive shaft to the tubular member so as longitudinally to vibrate the tubular member and means for withdrawing removed biological material up to the tubular member from the said end thereof.

Aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims do not form part of the claimed invention and are merely provided for illustrative purposes. In particular, methods for treatment of the human or animal body by surgery or therapy are not part of the invention as claimed. The present disclosure relates to a debris removal system. The system according to the invention includes an elongated shaft extending from a proximal end to a distal end and including a shaft lumen, the shaft being configured to be inserted through a bodily lumen to a target surgical site, a vibration motor coupled to the elongated shaft via a vibration collar, the vibration motor including a rotatable shaft and at least one weight coupled to the rotatable shaft, the weight being asymmetrically shaped about a central axis of the shaft such that rotation of the shaft creates vibrational energy along the length of the elongated shaft to dislodge debris within the target surgical site, and a vacuum pump connected to the elongated shaft and configured to vacuum dislodged debris from the target surgical site through the shaft lumen.

In an embodiment, the vibration collar comprises a housing including a compartment, the compartment configured to house at least a portion of the vibration motor therein.

In an embodiment, a portion of the rotatable shaft extends one of proximally and distally from the compartment, the weight being coupled thereto.

In an embodiment, the weight is substantially shaped as a semi-circle.

In an embodiment, the vacuum pump is connected to the elongated shaft via tubing.

In an embodiment, the elongated shaft includes at least one sensor, the sensor transmitting sensor data relating to the target surgical site to the processor, wherein if the sensor detects an obstruction in the surgical site, the processor automatically turns the motor on.

The present disclosure also relates to a debris removal system. The system includes an sheath extending from a proximal end to a distal end and including an lumen extending therethrough, the sheath being configured to deliver fluid to a target surgical site, a scope device including an elongated shaft extending from a distal end thereof, the elongated shaft configured to be inserted through the lumen of the sheath, a vibration motor configured to be coupled to the elongated shaft, the vibration motor providing vibration energy along the length of the elongated shaft to dislodge debris within the target surgical site, and a vacuum pump connected to the elongated shaft to suction dislodged debris from the target surgical site through the elongated shaft.

In an embodiment, the system further comprises a processor, the processor being configured to automatically control the vibration motor.

In accordance with the invention, the vibration motor is coupled to the elongated shaft via a vibration collar. In an example, the vibration collar extends from a proximal end to a distal end and includes a housing configured to house the vibration motor.

In an embodiment, the vibration collar includes a channel extending from the proximal end to the distal end and sized and shaped to receive the elongated shaft therethrough.

In an embodiment, the vibration motor includes a rotatable shaft and at least one eccentric weight coupled thereto.

In an embodiment, the system further includes a collection canister, the collection canister being fluidly connected to both the scope device and the vacuum pump so that dislodged debris is drawn from the target surgical site to the collection canister.

In an embodiment, the sheath includes a seal configured to prevent back flow of fluid through the lumen.

In an embodiment, the scope device further comprises a handle, the handle including at least one button configured to manually control the vibration motor or the power of the vibration motor.

The present disclosure also relates to a non-claimed method of removing a clog within a lumen. The method includes inserting an elongated shaft into a target lumen, the elongated shaft extending from a proximal end to a distal end and including a channel extending therethrough, detecting, via at least one sensor coupled to the distal end of the elongated shaft, a blockage within the target lumen, dislodging the blockage from the target lumen via a vibration motor coupled to the elongated shaft, the vibration motor including a rotatable shaft and at least one weight coupled to the rotatable shaft, the weight being asymmetrically shaped about a central axis of the shaft such that rotation of the rotatable shaft creates vibrational energy along the length of the elongated shaft within the target lumen, and vacuuming the dislodged blockage from the target lumen and through the elongated shaft channel via a vacuum pump fluidly connected to the elongated shaft, wherein the at least one sensor automatically triggers the motor vibration motor to turn on when a blockage is detected.

In an embodiment, the method further comprises inserting an access sheath into the target lumen, the access sheath extending from a proximal end to a distal end and including an lumen extending therethrough, the access sheath being sized and shaped to receive the elongated shaft therein and configured to deliver fluid to a target lumen.

In an embodiment, the method further comprises drawing the dislodged blockage into a collection canister, the collection canister being fluidly connected to the scope device and the vacuum pump so that dislodged blockage is drawn from the target lumen to the collection canister.

In an embodiment, the method further comprises transmitting a sensor data relating to the target lumen to a processor.

In an embodiment, the method further comprises automatically signaling the vibration motor to turn off when the at least one sensor detects that conditions within the target lumen have normalized.

The present invention may be understood with respect to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to devices, systems and methods for the removal of debris within a lumen through use of vibration energy. Exemplary embodiments describe a system including a lumen such as a catheter or scope an with sensors at the tip, a vibration motor and, in some embodiments, a LithoVue™ scope device. The system may include a vacuum source to suction the dislodged debris out of the lumen. Other exemplary embodiments describe a collection point for the debris. It should be noted that the terms "proximal" and "distal" as used herein are intended to refer to a direction toward (proximal) and away from (distal) a user of the device.

As shown in <FIG>, a system <NUM> according to an exemplary embodiment of the present disclosure comprises an access sheath <NUM> for providing access into a bodily lumen (e.g., along a tortuous path through a natural body lumen accessed via a naturally occurring body orifice), a shaft <NUM> and a vibration collar <NUM> with a vibration motor <NUM> for inducing energy within the lumen to dislodge debris therein. The system <NUM> may further comprise a scope assembly <NUM> including a handle <NUM>, which remains outside of a living body while the shaft <NUM> is inserted through the sheath <NUM>. The scope assembly <NUM> permits the user to control the vibration motor <NUM> via an actuator while the sheath <NUM> and shaft <NUM> are in the lumen. The scope assembly <NUM> also includes an actuator for a vacuum pump <NUM>.

As shown in <FIG>, the access sheath <NUM> comprises an elongated member extending longitudinally from a proximal end <NUM> to a distal end <NUM> and including a lumen <NUM> extending therethrough. The sheath <NUM> may be substantially tubular and it may be made of any suitable biocompatible material such as polyurethane, plastic, or any other such material. Other suitable cross-sectional shapes such as elliptical, oval, polygonal, or irregular may also be contemplated. The sheath <NUM> may be flexible along its entire length or adapted for flexure along portions of its length. Alternatively, the sheath's distal end <NUM> may be flexible while a remaining proximal portion of the shaft <NUM> is rigid. Flexibility allows the sheath <NUM> to maneuver in circuitous lumens, while rigidity provides the required force to urge the sheath <NUM> forward. The sheath <NUM> provides a fluid path to deliver, for example, irrigation fluid to the target lumen or cavity. In an exemplary embodiment, the access sheath <NUM> includes a seal component <NUM> at the proximal end <NUM>. The seal <NUM> may be integrally formed with the access sheath <NUM> or it may be a separate component that is coupled or clipped on to the access sheath <NUM>. The seal <NUM> allows the shaft <NUM> of the scope <NUM> to be inserted through the access sheath <NUM> and into the target lumen without the system <NUM> losing pressure. Specifically, the seal <NUM> prevents back flow of the irrigation fluid provided through the access sheath lumen <NUM>. It would be understood by one skilled in the art that the seal <NUM> does not need to be a tight seal but just allow enough pressure to be sustained within the access sheath <NUM> to push most of the irrigation fluid into the target lumen.

In an exemplary embodiment depicted in <FIG>, a scope device <NUM> such as, for example, a ureteroscope, provides vacuum to the target lumen to remove debris therefrom. The scope <NUM> includes a scope shaft <NUM> sized and shaped to be inserted through the lumen <NUM> of the access sheath <NUM> and including a working channel <NUM>. As shown in <FIG>, the scope <NUM> may be connected to the vacuum pump <NUM> via a supply line (i.e., tubing <NUM>), as described below. Thus, the vacuum pump <NUM> provides a source of vacuum pressure through the tubing and the working channel <NUM> of the shaft <NUM> to the target lumen within the patient. In an exemplary embodiment, the scope <NUM> may include at least one sensor <NUM> incorporated therein. For example, in one embodiment, the scope <NUM> may include a pressure transducer <NUM> at a distal tip <NUM> of the scope shaft <NUM> to measure pressure within, for example, the kidney. Alternatively, the pressure transducer <NUM> may be located on a guide wire, the access sheath <NUM> or externally along tubing <NUM>. The scope <NUM> may include other sensors such as, in one embodiment, a camera <NUM>, as described in further detail below. The scope <NUM> further includes a handle <NUM>, as shown in <FIG>. The handle <NUM> allows the user to control when the motor <NUM> is providing vibration energy to the shaft <NUM> via a motor on/off switch (not shown). In an exemplary embodiment, the manual motor buttons may override the system's automatic control of the motor <NUM>. That is, if the system <NUM>, through use of one of the sensors <NUM>, has detected a blockage and signaled to the motor <NUM> to turn on, the user may override this command using the manual switches. In an embodiment, the handle <NUM> may also include a vacuum on/off button (not shown). Thus, the user has discretion to turn the vacuum on when debris, fluid, etc. is within the target lumen but can turn the vacuum off when suction is unnecessary.

The vibration collar <NUM> including the electric rotary vibration motor <NUM>, as shown in <FIG>, is coupled to the scope shaft <NUM> to facilitate vibration along a length thereof. The vibration collar <NUM> extends from a proximal end <NUM> to a distal end <NUM> and includes a housing <NUM> comprising a compartment <NUM> for the vibration motor <NUM>. The vibration motor <NUM>, in this embodiment, has a rotatable shaft <NUM> extending along a central longitudinal axis, S, which may be fully disposed within the compartment <NUM> or, in another embodiment, may extend proximally or distally from the compartment <NUM>, as shown in <FIG>. The shaft <NUM> includes at least one eccentric weight <NUM> coupled thereto. For example, as shown in <FIG>, the weight may be configured as a semi-circle. Because the weight <NUM> is asymmetrically shaped about the central axis S of the shaft <NUM>, the shaft <NUM>, when rotated, is off-balance about its axis toward the weighted side, causing a vibration when the shaft <NUM> rotates. Thus, the vibration frequency will be equal to the number of revolutions of the motor. As shown in the figure, the weight <NUM> may be coupled to a proximal end of the shaft <NUM> extending proximally from the housing <NUM>. However, it will be understood that the weight <NUM> may be coupled to the shaft <NUM> at any point along its length, so long as the shaft <NUM> with the weight <NUM> attached is capable of rotating freely. Electric energy may be provided to the vibration motor <NUM> via wires <NUM> which provide a connection to an electrical source. In an example, the wires <NUM> are connected to the handle, which in turn has an electrical source such as, for example, a battery or an electrical line to an outlet. In an exemplary embodiment, the vibration motor <NUM> may automatically be activated by a sensor stimulus, as described in further detail below. In another exemplary embodiment, the motor <NUM> may also be manually activated by the user using the on/off switch on the handle <NUM>.

The vibration collar <NUM> includes a channel <NUM> extending therethrough from the proximal end <NUM> to the distal end <NUM>. The channel <NUM> is sized and shaped to receive the scope shaft <NUM> therethrough. For example, a diameter of the channel <NUM> may be equal to or slightly larger than the outer diameter of the shaft <NUM>. The vibration collar <NUM> may be coupled to the shaft <NUM> via any coupling mechanism such as, for example, friction fit, a shrink tube, or by an adhesive. In an exemplary embodiment, shown in <FIG>, the vibration collar <NUM> is coupled to the shaft <NUM> at a position within a distal end of the scope device <NUM>. In an embodiment, the vibration collar <NUM> may be integrally formed with the scope <NUM> such that the vibrational energy passes along the entire length of the shaft <NUM> along the axis of the shaft <NUM>. However, in another exemplary embodiment, shown in <FIG>, the vibration collar <NUM> may be coupled to the shaft <NUM> at any user preferred point along its length. Thus, the vibrational energy may be focused on a specific length of the shaft <NUM> so that the vibrational energy may be more concentrated at the blockage point.

Although the access sheath <NUM>, in the present embodiment, is used to provide a path for fluid to the target lumen and the scope shaft <NUM> is used to vacuum debris from the target lumen, one skilled in the art would understand that it is possible to reverse the flow path such that the scope shaft <NUM> provides fluid to the target lumen and the access sheath <NUM> is used to vacuum debris from the target lumen. However, in this embodiment where the flow path is reversed and the access sheath <NUM> is used to vacuum debris, the vibration collar <NUM> and vibration motor <NUM> is coupled to the access sheath <NUM>. That is, the vibration energy is applied to the component - i.e., access sheath <NUM>, scope shaft <NUM> - that is connected to the vacuum pump <NUM> so that debris suctioned therethrough can be dislodged by the vibration motor <NUM>. In another exemplary embodiment, the scope shaft <NUM> may include two lumens, one for suction and another for irrigation. In this embodiment, the vibration collar <NUM> and vibration motor <NUM> could be coupled to this shaft <NUM>, eliminating the need for an access sheath. One ordinarily skilled in the art will understand that more than one vibration motor <NUM> could be coupled to the scope shaft <NUM>.

In an exemplary embodiment, the scope <NUM> may be connected to a collection canister <NUM> as a collection point for the debris, tissue, fluid, etc. In an embodiment, tubing <NUM> may lead from the scope <NUM> to the collection canister <NUM>, which is connected, via further tubing <NUM>, to the vacuum pump <NUM>, as shown in <FIG>. Thus, the vacuum pump <NUM> provides suction through the collection canister <NUM> and the scope working channel <NUM>, creating low pressure in the collection canister <NUM> to draw the debris as well as fluid, etc. out of the target lumen and into the collection canister <NUM>. In an exemplary embodiment, the collection canister <NUM> may include a weight sensor <NUM>. The weight sensor (not shown) may be operatively connected to a processing device, as discussed in further detail below.

In an embodiment, the system <NUM> may include a processing device <NUM>, such as a computer. The processing device <NUM> may be operatively connected to one or more system components such as, for example, the scope device <NUM>, the vacuum pump <NUM> and/or the weight sensor <NUM>. The processing device <NUM> is capable of performing various functions such as calculation, control, computation, etc. For example, the processing device <NUM> may receive signals or data from the sensors <NUM> of the system <NUM> - i.e., pressure transducer, camera, flow meter - and determine from the data provided when and if the vibration motor <NUM> should be turned on. The processing device <NUM> may also be configured to include visual software/image recognition software that can detect visual noise from the camera. If the image provided to the processing device <NUM> is determined to not be sufficiently clear or sharp, the vibration motor <NUM> is turned on to break up the debris until the image is sharpened or cleared. The vibration motor <NUM> may be turned on for a temporary time (i.e., a predetermined period) or until the field of view is deemed to be sufficiently clear. In another example, if the pressure transducer at the distal tip of the scope <NUM> detects a rise in pressure within the cavity during suction of the debris, the system will assume that there is a blockage in the working channel <NUM> causing the pressure to rise and a signal will be sent to the processing device <NUM> which will automatically turn the vibration motor <NUM> on. An exemplary rise in pressure may be approximately <NUM>-<NUM>% from the baseline pressure. In another exemplary embodiment, the system <NUM> may include a flow meter <NUM>. In this embodiment, if the flow meter detects a reduction in fluid flow within the working channel <NUM>, a signal will be sent to the processing device <NUM> which will turn on the vibration motor <NUM> until the clog is dislodged and the fluid flow returns to a normal flow rate. In yet another exemplary embodiment, if the collection canister <NUM> includes a weight sensor <NUM>, the collection canister <NUM> is weighed during the procedure. If the sensor <NUM> detects no change in weight for a predetermined amount of time such as, for example, <NUM>-<NUM> seconds, the system will assume that there is a blockage in the working channel <NUM> and a signal may be sent to the processing device <NUM> to automatically turn on the vibration motor <NUM>.

In an exemplary embodiment, the processing device <NUM> includes a user interface component such as a touch screen interface <NUM>. The user interface may include a display screen as well as touch buttons. The user interface allows the user to turn on/off various functions of the system <NUM> such as, for example, the vibration motor <NUM>. That is, in an embodiment, the user is able to manually control the vibration motor <NUM> from the user interface or from the scope handle <NUM>. In another embodiment, the user interface may include vibration motor control button in lieu of the scope handle <NUM>. Each of the various sensors <NUM> being used may be managed by the user interface, which also allows the user to add, change, or discontinue use of the various sensors. The user interface component may also be used to change the vibration motor <NUM> between automatic and manual modes for various procedures.

An exemplary method for removing debris from a clogged working channel <NUM> includes inserting the distal end of the access sheath <NUM> into a target channel and advancing the sheath <NUM> therethrough to a target cavity within, for example, the kidney. In some embodiments, irrigation fluid may be provided through the lumen <NUM> of the access sheath <NUM> and into the target channel. Once the access sheath <NUM> is positioned within the kidney as desired, the shaft <NUM> of the scope <NUM> is advanced through the lumen <NUM> of the sheath <NUM> until the distal end thereof extends past the distal end <NUM> of the access sheath <NUM>. As the scope <NUM> is advanced into the target lumen, sensors <NUM> positioned on the distal end of the scope shaft <NUM> provide feedback to the processing device <NUM> regarding conditions of the target anatomy in which the scope <NUM> is positioned as well as conditions within the working channel <NUM> of the scope shaft <NUM>, which may then be displayed on a display screen. During, for example, a lithotripsy, a kidney stone is broken up into multiple fragments and the scope <NUM> is used to suction the fragments through the working channel <NUM> of the shaft <NUM>. While the debris is being suctioned through the system <NUM>, if the sensors <NUM> determine that there is a blockage clog formed by, for example, a kidney stone fragments, in the working channel <NUM>, the sensors <NUM> will automatically trigger the motor <NUM> to turn on. Because the motor <NUM> and motor collar <NUM> are coupled to the scope shaft <NUM>, vibration energy is provided along the length of the shaft <NUM> to dislodge the debris and break up the clog within the working channel <NUM>. Once the debris is dislodged, the vacuum pump <NUM> continues to vacuum the debris from the working channel <NUM> of the shaft <NUM> of the scope <NUM> and into the collection canister <NUM>. As the sensors <NUM> detect that conditions have normalized (i.e., the obstruction has been removed), the system <NUM> will turn off the motor <NUM>. At any point in the procedure, the user may switch the system <NUM>, via the user interface <NUM> or other physical switch, so that components thereof, such as the motor <NUM>, vacuum pump <NUM>, etc., may be adjusted manually. Manual adjustment may occur through use of the buttons on the scope handle or through buttons on the user interface.

It will be appreciated by those skilled in the art that the current devices and methods are not limited to the disclosed embodiments. For example, the disclosed debris removal system <NUM> may be used in various other procedures such as, for example, hysteroscopies, cystoscopies, etc. Thus, the system <NUM> is not limited to use with a ureteroscope but may be used with other devices such as cystoscopes, hysteroscopes or any other device with a shaft inserted into a body channel/lumen/cavity.

Claim 1:
A debris removal system (<NUM>), comprising:
an elongated shaft (<NUM>) extending from a proximal end to a distal end and including a shaft lumen (<NUM>), the shaft (<NUM>) being configured to be inserted through a bodily lumen to a target surgical site;
a vibration motor (<NUM>) coupled to the elongated shaft (<NUM>) via a vibration collar (<NUM>), the vibration motor (<NUM>) including a rotatable shaft (<NUM>) and at least one weight (<NUM>) coupled to the rotatable shaft (<NUM>), the weight (<NUM>) being asymmetrically shaped about a central axis (S) of the shaft (<NUM>) such that rotation of the shaft (<NUM>) creates vibrational energy along the length of the elongated shaft (<NUM>) to dislodge debris within the target surgical site; and
a vacuum pump (<NUM>) connected to the elongated shaft (<NUM>) and configured to vacuum dislodged debris from the target surgical site through the shaft lumen (<NUM>).