Patent Description:
Cannulation tubes are used to form and create an open tube access in a patient for the removal or insertion of fluids, samples, or tools. Placing a cannula may be done manually by cutting the skin and inserting increasing dilators and a location of the cannula is based on the type of procedure performed. A cannula may be positioned and left in place for short or long-term duration.

From <CIT> a cannulation tool according to the preamble of claim <NUM> is known. From <CIT> a rod is known thereof for forcibly moving each tube of a set of tubes, in sequence, from a retracted position to an extended position.

The object of the present invention is to provide an improved cannulation tool and a cannulation system comprising the improved cannulation tool. This object is solved by a cannulation tool according to claim <NUM> and by a cannulation system according to claim <NUM>. Further embodiments are subject of the dependent claims. Example aspects of the present disclosure include:.

A cannulation tool according to the present disclosure comprises: a body; a plurality of tubes removably secured to the body, each tube moveable from a retracted position to an extended position, the plurality of tubes including an inner tube, an outer tube, and a set of tubes positioned between the inner tube and the outer tube, each tube of the set of tubes nested in an adjacent tube, the outer tube positioned external to the set of tubes, and the inner tube positioned internal to the set of tubes; and a gripper rod having a gripper disposed on a gripper first end thereof for forcibly moving each tube of the set of tubes, in sequence, from the retracted position to the extended position, wherein a pair of arms are disposed at the gripper first end, wherein each arm of the pair of arms comprises a primary arm and a secondary arm, wherein the primary arms form a first set of gripper arms when the gripper is in any one of a plurality of first configurations, and the secondary arms form a second set of gripper arms when the gripper is in a second configuration, wherein the first set of gripper arms is operable to move in sequence from one of the plurality of first configurations to another of the plurality of first configurations so as to successively move each tube of the plurality of tubes from a corresponding retracted position to a corresponding extended position, and wherein the second set of gripper arms is operable to move the inner tube and the plurality of tubes back to a retracted position when the gripper is in the second configuration.

Any of the aspects herein, wherein the inner tube and each tube of the set of tubes comprises a protrusion on an outer surface thereof, each protrusion configured to engage a groove on an inner circumference of an adjacent tube.

Any of the aspects herein, further comprising a motor configured to cause the gripper rod to selectively extend and retract.

Any of the aspects herein, further comprising an oscillation rail mounted to the body that causes the gripper rod to oscillate during an extension or retraction movement.

Any of the aspects herein, wherein the gripper moves the outer tube from the retracted position to the extended position.

Any of the aspects herein, wherein the gripper moves the inner tube from the retracted position to the extended position.

Any of the aspects herein, wherein the gripper is reconfigurable from the first configuration to the second configuration, the gripper operable to retract both the set of tubes and the inner tube when the gripper is in the second configuration.

Any of the aspects herein, wherein the gripper is biased towards the second configuration.

Any of the aspects herein, wherein the inner tube includes a pin on an inner surface thereof, and further wherein the gripper is configured to grip the pin when the gripper is in the second configuration to retract the plurality of tubes.

Any of the aspects herein, wherein the outer tube is configured to remain in the extended position when both the set of tubes and the inner tube are retracted.

Any of the aspects herein, wherein the outer tube includes a first portion and a second portion, the first portion configured to detach from the second portion and remain in the extended position when the second portion is retracted.

Any of the aspects herein, wherein the body comprises a first end and a second end, the tool further comprises: a blade positioned at the first end and operable to cut through soft tissue, and the plurality of tubes is positioned at the second end.

Any of the aspects herein, wherein the inner tube includes a conical end.

A cannulation system according to at least one embodiment of the present disclosure comprises: the cannulation tool according to the present disclosure; at least one processor; and at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: cause the gripper to move each tube of the set of tubes, in sequence, from the retracted position to the extended position, and cause the gripper to move the set of tubes, simultaneously, from the extended position to the retracted position.

Any of the aspects herein, wherein the gripper is reconfigurable from a first configuration to a second configuration, the gripper operable to retract the set of tubes when the gripper is in the second configuration.

Any of the aspects herein, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the gripper to move the inner tube from the retracted position to the extended position, and cause the gripper to move the inner tube, simultaneously with the set of tubes, from the extended position to the retracted position, wherein the inner tube includes a pin on an inner surface thereof, and further wherein the gripper is configured to grip the pin when the gripper is in the second configuration to retract the inner tube and the set of tubes.

Any of the aspects herein, wherein the at least one memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: cause the gripper to move the outer tube from the retracted position to the extended position, and wherein the outer tube is configured to remain in the extended position when the set of tubes is retracted.

It should also be understood that the examples or embodiments of present invention will be described herein with reference to illustrative methods, which are included to further the understanding of the inventive cannulation tool and the inventive cannulation system, and the in practical use of the inventive cannulation tool, device or system certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to make use of the disclosed inventive tool, device and system according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the devices of this disclosure may be implemented by a combination of units or modules associated with, for example, a computing device and/or a medical device.

In one or more examples, the described illustrative methods and processes may be implemented in hardware, software, firmware, or any combination thereof.

Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.

In some cases of minimally invasive surgery, endoscopy, or certain surgical procedures, it may be beneficial to create an open tube access, which may be done by placing a cannula. Placing a cannula may be done manually by cutting the skin and inserting dilators of increasing size by manually creating a linear and torque movement or by using mechanical separators. Placing the cannula requires accuracy and may take a significant amount of time. Achieving the needed accuracy frequently involves a significant radiation exposure for both a patient and a surgical team, as radiation-based imaging is used to ensure proper placement of the cannula. Further, the process of placing a cannula may be time intensive and surgeon fatigue may affect performance and operating time during later stages of the surgical operation.

Embodiments of the present disclosure provide for a motorized cannulation system that can be used to establish endoscopic access or place a tubular retractor quickly, automatically, and accurately without requiring excess radiation exposure. The system may be an electro-mechanical unit placed on a rigid base or a robotic system, using a controlled combined mechanism of skin cutting and insertion of increasing dilators using linear and oscillating movement. A robotic system can position the cannulation system in the desired position and orientation based on a planned track or trajectory. The cannulation system performs a skin cut, inserts a guiding needle, and places incrementally larger cannulae over the guide while performing gentle oscillating rotation movements during insertion. Upon achieving the required tube width, the inner cannulae are removed.

Embodiments of the present disclosure provide for a cannulation system that employs a novel mechanism to support the described functionality with, for example, a single motor and components having a small form factor such as a twisted cam follower for oscillation movement, scissor-like grippers with dual functionality for both gripping each cannula and removing the inner mechanism, and increasingly larger side knobs that allow for stages of insertion of the cannulas one tube at a time. By controlling the speed, force, and the linear advancement of the system, the process may be pre-planned to achieve the results required without manual interference. The system provides for more complete automation of percutaneous and minimally invasive procedures that will enhance procedural safety and efficiency while also simplifying training, reducing surgeon fatigue, and taking less time.

As described more fully below, systems, and devices for inserting a cannula may beneficially reduce operating time by providing a streamlined automated process. The cannulation device may also improve accuracy of placing the device and may thereby reduce trauma to the surrounding patient area.

Turning first to <FIG>, a cannulation tool or a cannulation device <NUM> is shown. The cannulation tool or device <NUM> includes a plurality of tubes <NUM> wherein each tube is moveable from one retracted position of a plurality of retracted positions to one extended position of a plurality of extended positions. The plurality of tubes <NUM> are held in the retracted position at a base <NUM> prior to use. In the illustrated embodiment, the plurality of tubes <NUM> includes an inner tube 110A, an outer tube 110B, and a set of tubes <NUM>. In the illustrated embodiment, the set of tubes includes three tubes 110C, D, E positioned between the inner tube 110A and the outer tube <NUM>10B. In other embodiments, the set of tubes <NUM> includes less than three tubes or more than three tubes. The number of tubes in the set of tubes can be based on a desired size of the opening. Each tube of the set of tubes <NUM> is nested in an adjacent tube. The tubes <NUM> may be made of stainless steel, polyetheretherketone (PEEK), or any other metal, metal alloy, plastic, composite, or other material having sufficient rigidity to hold its shape during and after insertion into the body and having biocompatible properties that enable use thereof within a patient's body during a surgical procedure.

In the illustrated embodiment, the plurality of tubes <NUM> is disposed on a body <NUM> having a first end <NUM> and a second end <NUM>. The body <NUM> may be in the form of a plate with an extension <NUM>, as illustrated, or may be in any other form or shape including, but not limited to, a cylinder, a box, an oval, a circle, a rectangle, or the like. The first end <NUM> may be positioned near a skin of a patient when the body <NUM> is in a first position and the second end <NUM> may be positioned near the skin of the patient when the body <NUM> is in a second position. The body <NUM> may rotate or otherwise move between the first position and the second position. The plurality of tubes <NUM> may be positioned at the second end <NUM> and a blade <NUM> may be positioned at the first end <NUM>. The blade <NUM> is operable to cut an incision or opening into the skin when the body <NUM> is in the first position.

The tool or device <NUM> may also include a gripper rod <NUM> having a gripper <NUM> (shown in detail in <FIG>) disposed on a gripper first end <NUM>. The gripper <NUM> is configured to forcibly move each tube of the plurality of tubes <NUM> from a respective retracted position to a respective extended position in sequence from the inner tube 110A to the outer tube 110B. The tool or device <NUM> may also include a motor <NUM> operatively connected to the gripper rod <NUM> and configured to cause the gripper rod <NUM> to selectively extend and retract. As labeled in <FIG>, the motor <NUM> is disposed on the extension <NUM> and spins a shaft <NUM> with external threads, which engages internal threads of a bracket <NUM>. A gripper second end <NUM> (visible in <FIG>) of the gripper rod <NUM> is coupled to the bracket <NUM>. The bracket <NUM> is also connected to a linear rail <NUM> adjacent and parallel to the shaft <NUM>, which linear rail <NUM> assists in maintaining the bracket <NUM> substantially perpendicular to the shaft <NUM>. Due to the threaded engagement of the shaft <NUM> with the bracket <NUM>, rotation of the shaft <NUM> causes the bracket <NUM> to move along the shaft <NUM> and the linear rail <NUM>. The second end <NUM> of the gripper rod <NUM> is rotatably connected to the bracket <NUM>, such that movement of the bracket in a length dimension along the shaft <NUM> also causes movement of the gripper rod <NUM> along the same dimension. In some embodiments, the tool or device <NUM> may not include the motor <NUM>, but may instead comprise a connector or other hookup to which an external motor may be operatively attached. The motor <NUM> may be an electric motor with a rotor and stator, a linear induction motor, a pneumatic motor, a hydraulic motor, a gear motor, an AC brushless motor, a DC brushed motor, a DC brushless motor, a servo motor, or the like.

The tool or device <NUM> may also include an oscillation rail <NUM> that causes the gripper rod <NUM> (and thus, the gripper <NUM>) to oscillate during an extension or retraction movement (e.g., a movement in a length dimension parallel to the shaft <NUM>). The oscillation rail <NUM> is positioned parallel to the shaft <NUM>. A cam follower <NUM> disposed on the gripper second end <NUM> engages the oscillation rail <NUM>, which forces the cam follower <NUM> (and thus the gripper rod <NUM>) from side to side as the bracket <NUM> moves up and down the shaft <NUM>. Such oscillation movement causes a vibration-like movement that facilitates insertion of each tube of the plurality of tubes <NUM> into the opening by helping to overcoming the friction and resistance of tissue surrounding the opening. Further, the oscillation rail <NUM> allows for the use of a smaller motor as less power is needed to insert each tube.

Turning to <FIG>, the gripper rod <NUM> and a close up of the gripper <NUM> are shown. The gripper <NUM> includes the gripper rod <NUM> that extends from a gripper first end <NUM> to the gripper second end <NUM>. The cam follower <NUM> is disposed at the gripper second end <NUM> and a pair of arms <NUM> are disposed at the gripper first end <NUM>. Each arm of the pair of arms <NUM> comprises a primary arm <NUM> and a secondary arm <NUM>. The primary arms <NUM> form a first set of gripper arms <NUM> when the gripper <NUM> is in any one of a plurality of extension positions or first configurations, including the extension position or first configuration shown in <FIG>, and the secondary arms <NUM> form a second set of gripper arms <NUM> when the gripper <NUM> is in a retracting position or a second configuration, shown in <FIG>. The first set of gripper arms <NUM> is operable to move in sequence from one of a plurality of extension positions or first configurations to another of the plurality of extension positions or first configurations (with each successive position or configuration being defined by a slightly larger distance between the tips of the primary arms <NUM>) so as to successively move each tube of the plurality of tubes <NUM> from a corresponding retracted position to a corresponding extended position. The second set of gripper arms <NUM> is operable to move the inner tube 110A and the set of tubes <NUM> back to a retracted position when the gripper <NUM> is in the retracting position or the second configuration. As shown in the illustrated embodiment, the secondary arms <NUM> are shorter in length than the primary arms <NUM>. In other embodiments, the secondary arms <NUM> may be longer in length that the primary arms <NUM> or the secondary arms <NUM> may be the same length as the primary arms <NUM>.

The pair of arms <NUM> is biased to the retracting position or the second configuration. In some embodiments, the pair of arms <NUM> may be biased by a spring such as a leaf spring, coil spring, torsion spring, or the like. In the illustrated embodiment, the pair of arms <NUM> is biased by a torsion spring <NUM>. In other embodiments, a portion of or all of the pair of arms <NUM> may be formed from a resilient material to bias the pair of arms <NUM> to the retracting position or the second configuration. The pair of arms <NUM> may be held in (or caused to move into) one of the plurality of extension positions or first configurations by a holder <NUM>, shown in <FIG>. The holder <NUM> may be a tab, bar, or the like. In the illustrated embodiment, the holder <NUM> is a plurality of pegs that prevent the gripper <NUM> from moving into the retracting position or the second configuration by preventing rotation of the pair of arms <NUM>. In the illustrated embodiment, a first pair of pegs of the holder <NUM> are positioned closer to the plurality of tubes <NUM> and a second pair of pegs are positioned above the first pair of pegs (e.g., on an opposite side of the first pair of pegs from the plurality of tubes <NUM>). The first pair of pegs are spaced further apart than the second pair of pegs such that, when the gripper rod <NUM> retracts sufficiently to pull the gripper <NUM> into the holder <NUM>, the pair of arms <NUM> first contacts the first pair of pegs, which counteract the biasing force of the torsion spring <NUM> and push the pair of arms <NUM> into an extension position or the first configuration. A hump or bump in the outer contour of the pair of arms <NUM> (when in an extension position or the first configuration) is configured to engage the second pair of pegs, the interaction of which with the outer contour of the pair of arms <NUM> causes the tips of the primary arms <NUM> to move (against the biasing force of the torsion spring <NUM>) even closer together. In other words, the first pair of pegs funnels the pair of arms <NUM> into the second pair of pegs, thereby closing the pair of arms <NUM>. When the pair of arms <NUM> are uninhibited, the pair of arms <NUM> move to the retracting position or the second configuration.

Each tube in the plurality of tubes <NUM> comprises a pair of oppositely positioned slots <NUM> on an inner circumference thereof. The slots <NUM> are defined by the outer wall of the tube and by a bottom surface <NUM>, and are wide enough (in the circumferential direction) to receive the primary arms <NUM> of the gripper <NUM>. When the gripper <NUM> is moved downward (e.g., by operation of the motor <NUM>, which spins the shaft <NUM> and causes the bracket <NUM> to move toward the set of tubes, thus also causing the gripper rod <NUM> and the gripper <NUM> to move in the same direction), the tips of the primary arms <NUM> contact the bottom surface <NUM> of the slot <NUM> of the first, inner tube 110A, and push the inner tube 110A into an extended position. The motor <NUM> then reverses, causing the gripper <NUM> to move upward within the second tube 110C (which keeps the gripper <NUM> in an extension position or a first configuration) until the gripper <NUM> reaches the slot <NUM> of the second tube 110C. When the gripper <NUM> reaches the slot <NUM> of the second tube 110C, the biasing force of the spring <NUM> pushes the tips of the primary arms <NUM> away from each other until they contact the outer wall of the slot <NUM> (which is also the outer wall of the tube 110C). The motor <NUM> then reverses direction again, causing the gripper <NUM> to push against the bottom surface <NUM> of the slot <NUM> of the second tube 110C so as to push the second tube 110C into an extended position. This process then continues until the gripper <NUM> has pushed all of the tubes <NUM> into the extended position.

Turning to <FIG>, the plurality of tubes <NUM> is shown. As previously described, the plurality of tubes <NUM> includes the inner tube 110A, the outer tube 110B, and the set of tubes <NUM> (e.g., tubes 110C, 110D, 110E) in between the inner tube 110A and the outer tube 110B. In the illustrated embodiment, the inner tube 110A includes a conical tip <NUM>. The tip <NUM> may aid in insertion of the inner tube 110A into an incision or opening formed by the blade <NUM> (or formed in any other manner) and may act as a guide for each subsequent insertion of a tube from the plurality of tubes <NUM>. In other embodiments, the inner tube 110A may include any shape tip such as, for example, an open conical tip, a blunt tip, a flat tip, or the like. In some embodiments, the tip of the inner tube 110A may be configured to receive a guide needle that has already been placed along the proper trajectory within the patient. In such embodiments, the inner tube 110A may be inserted over the guide needle to ensure that the inner tube 110A is inserted along the proper trajectory.

As illustrated, each tube in the plurality of tubes <NUM> increases in diameter from the inner tube 110A to the outer tube 110B. Each subsequent tube from the plurality of tubes <NUM> may also have a wedge-shaped lower or distal end to facilitate dilation of the incision or opening into which the tube is being inserted. During insertion, the incision or opening becomes wider as each tube is inserted into the incision or opening. Thus, the number of tubes in the plurality of tubes <NUM> may be based on the desired size of the opening (which may, in turn, be based on the size of the surgical instruments to be used during a surgical procedure that will take place, in whole or in part, through the installed cannula). In some embodiments, the plurality of tubes <NUM> can include two tubes and in other embodiments, the plurality of tubes can include more than two tubes <NUM>.

The inner tube 110A and each tube of the set of tubes <NUM> includes a protrusion <NUM> positioned on an outer circumference thereof, and the outer tube 110B and each tube of the set of tubes <NUM> includes a groove <NUM> formed on an inner circumference thereof. In some embodiments, the wider the tube <NUM> is, the larger the corresponding protrusion <NUM> is. In other embodiments, each tube <NUM> may have the same sized protrusion <NUM>. The protrusion <NUM> of one tube is removably engaged to the groove <NUM> of an adjacent tube. Thus, the groove <NUM> of each tube having such a groove <NUM> is sized to receive the protrusion <NUM> of the tube or cannula that fits immediately inside of the tube with the groove <NUM>. Such engagement maintains each tube of the plurality of tubes <NUM> in the retracted position until the gripper <NUM> forcibly moves each tube to the extended position. The graduated size of the protrusions <NUM> (and corresponding grooves <NUM>) prevents the plurality of tubes <NUM> from moving into the corresponding extended position as a single unit, and instead allows for one tube at a time to be moved to the corresponding extended position. This is because the force required to dislodge a smaller protrusion <NUM> from a smaller groove <NUM> is less than the force required to dislodge a larger protrusion <NUM> from a larger groove <NUM>. Similarly, the protrusion <NUM> is also removably engaged to the groove <NUM> to couple a tube in the corresponding extension position to an adjacent tube when the adjacent tube is moved to the corresponding extension position. When each tube, except for the outer tube 110B, is coupled to an adjacent tube in a respective extension position, then the inner tube 110A and the set of tubes <NUM> can be removed as one unit from the opening, as shown in <FIG>.

Turning to <FIG>, the outer tube 110B is illustrated and a detailed view of the outer tube 110B removably engaged to the base <NUM> are respectively shown. The outer tube 110B in some embodiments includes a first portion <NUM> and a second portion <NUM> (shown in <FIG>). In other embodiments, the outer tube 110B is one singular piece. In embodiments where the outer tube 110B includes the first portion <NUM> and the second portion <NUM>, the first portion <NUM> and the second portion <NUM> may be removably engaged to each other. In some embodiments, such engagement results from a snap fit between the first portion <NUM> and the second portion <NUM>. In other embodiments, the engagement is formed by a friction fit. In other embodiments, such engagement is enabled by a reusable adhesive (or, where the outer tube 110B is not intended for sterilization and re-use, by a non-reusable adhesive). In some embodiments a surgeon or a robot may forcibly break the first portion <NUM> from the second portion <NUM>. In further embodiments, one of the first portion <NUM> or the second portion <NUM> may have a protrusion and the other one of the first portion <NUM> or the second portion <NUM> may have a groove for receiving the protrusion. In other embodiments, an outer fixation holder holds the first portion <NUM> and the second portion <NUM> and is operable to release the first portion <NUM>.

The first portion <NUM> of the outer tube 110B, includes a protrusion <NUM> that is removably engaged to a groove <NUM> formed in the base <NUM>, shown in detail in <FIG>. The removable engagement of the outer tube 110B to the base <NUM> holds the outer tube 110B in the retracted position until forced out of the retracted position by the gripper <NUM>. Further, prior to moving any of the plurality of tubes <NUM> from the retracted position, the outer tube 110B holds the plurality of tubes <NUM> in the retracted position by way of the engagement between the outer tube 110B and the base <NUM> (together with the engagement of each inner tube with an adjacent tube by way of a protrusion <NUM> and a groove <NUM>). The outer tube 110B may be moved from a retracted position to an extended position when the first portion <NUM> and the second portion <NUM> are engaged to each other.

<FIG> illustrates the pair of arms <NUM> in the second configuration (e.g., the second set of arms <NUM>). When the pair of arms <NUM> is in the second configuration, the pair of arms <NUM> can grip a pin <NUM> protruding from an inner wall of the inner tube 110A and pull the set of tubes <NUM>, the inner tube <NUM>0A, and the first portion <NUM> of the outer tube 110B from the opening, as described below. The spring <NUM> biases the pair of arms <NUM> so as to exert sufficient gripping force on the pin <NUM> to enable the gripper <NUM> to pull the inner tube 110A, the set of tubes <NUM>, and the first portion <NUM> of the outer tube 110B from the opening. When the plurality of tubes <NUM> is removed from the opening, the first portion <NUM> may disengage or be caused to disengage from the second portion <NUM> so that the second portion <NUM> remains in the opening.

Turning to <FIG>, when the inner tube <NUM>0A, the set of tubes <NUM>, and the outer tube 110B are all in the extended position, the protrusions <NUM> and grooves <NUM> of the tubes <NUM> are once again in engagement with each other. Once the gripper <NUM> has been used to place the outer tube 110B in the opening and has been retracted, the spring <NUM> causes the gripper <NUM> to reconfigure into the retracting position or second configuration. When the gripper <NUM> is again extended toward the tubes <NUM>, The pair of arms <NUM>, now in the retracting position or second configuration, grips the pin <NUM> of the inner tube 110A. As a result, when the tool or device <NUM> is pulled away from the opening, the gripper <NUM> pulls the set of tubes <NUM>, the inner tube 110A, and the first portion <NUM> of the outer tube 110B from the opening, thereby leaving the second portion <NUM> of the outer tube 110B in the incision or opening. The second portion <NUM> of the outer tube 110B remains in the opening to keep a channel to a surgical site open and to thus provide a clean throughway for delivery or removal of fluid or samples, or insertion of a surgical tool or instrument. The second portion <NUM> may remain in the opening for a duration of the procedure and/or may remain in the opening after the procedure is completed.

Turning to <FIG>, a block diagram of a system <NUM> according to at least one embodiment of the present disclosure is shown. The system <NUM> may be used to facilitate use of the cannulation device or tool <NUM> with a patient. The system <NUM> may additionally or alternatively be used to execute cannulation device instructions <NUM> and/or to carry out other aspects of any illustrative method disclosed herein. The system <NUM> comprises a computing device <NUM>, an imaging device <NUM>, a navigation system <NUM>, a robot <NUM>, and/or a cannulation device or tool <NUM>. The cannulation device <NUM> shown in <FIG> is the same as or substantially similar to the cannulation device <NUM> described above with respect to <FIG>. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system <NUM>. For example, the system <NUM> may not include the imaging device <NUM>, the navigation system <NUM>, and/or the robot <NUM>. Embodiments of the present disclosure may comprise more than one of any of the components of the system <NUM>, including specifically the cannulation device <NUM>, the imaging device <NUM>, the robot <NUM>, and/or the robotic arm <NUM>.

The computing device <NUM> comprises a processor <NUM>, a memory <NUM>, a communication interface <NUM>, and a user interface <NUM>. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device <NUM>.

The processor <NUM> of the computing device <NUM> may be any processor described herein or any similar processor. The processor <NUM> may be configured to execute instructions stored in the memory <NUM>, which instructions may cause the processor <NUM> to carry out one or more computing steps utilizing or based on data received from the robot <NUM> and/or the navigation system <NUM>.

The memory <NUM> may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and/or instructions. The memory <NUM> may store information or data useful for completing, for example, any step of the illustrative method <NUM> described herein. The memory <NUM> may store, for example, one or more cannulation device instructions <NUM> and/or one or more surgical plans <NUM>. Such instructions may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. The instruction may cause the processor <NUM> to manipulate data stored in the memory <NUM> and/or received from the robot <NUM> and/or the navigation system <NUM>.

The computing device <NUM> may also comprise a communication interface <NUM>. The communication interface <NUM> may be used for receiving image data or other information from an external source (such as the imaging device <NUM>, the navigation system <NUM>, the robot <NUM>, and in some embodiments the cannulation device or tool <NUM>), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device <NUM>, the imaging device <NUM>, the navigation system <NUM>, the robot <NUM>, and/or the cannulation device or tool <NUM>). The communication interface <NUM> may comprise one or more wired interfaces (e.g., a USB port, an ethernet port, a Firewire port) and/or one or more wireless interfaces (configured, for example, to transmit information via one or more wireless communication protocols such as <NUM>1a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface <NUM> may be useful for enabling the device <NUM> to communicate with one or more other processors <NUM> or computing devices <NUM>, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

The computing device <NUM> may also comprise one or more user interfaces <NUM>. The user interface <NUM> may be or comprise a keyboard, mouse, trackball, monitor, television, touchscreen, headset, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface <NUM> may be used, for example, to receive a user selection or other user input regarding moving an inner cannula from a retracted position to an extended position; to receive a user selection or other user input regarding moving each cannula of a set of cannulas from a respective retracted position to a respective extended position; to receive a user selection or other user input regarding moving an outer cannula from a retracted position to an extended position using the gripper; to receive a user selection or other user input regarding retracting the inner cannula and the set of cannulas; and/or to display an image, the device instructions <NUM>, and/or the surgical plan <NUM>. In some embodiments, the user interface <NUM> may be useful to allow a surgeon or other user to modify the plan <NUM>, or other information displayed on or via the user interface <NUM>, though it will be appreciated that each of the preceding inputs may be generated automatically by the system <NUM> (e.g., by the processor <NUM> or another component of the system <NUM>) or received by the system <NUM> from a source external to the system <NUM>. In some embodiments, user input such as that described above may be optional or not needed for operation of the systems, devices, and illustrative methods described herein.

Although the user interface <NUM> is shown as part of the computing device <NUM>, in some embodiments, the computing device <NUM> may utilize a user interface <NUM> that is housed separately from one or more remaining components of the computing device <NUM>. In some embodiments, the user interface <NUM> may be located proximate one or more other components of the computing device <NUM>, while in other embodiments, the user interface <NUM> may be located remotely from one or more other components of the computer device <NUM>.

The imaging device <NUM> may be operable to image a patient and/or the cannulation device or tool <NUM> to yield an image and/or image data. The imaging device <NUM> may be capable of taking a 2D image or a 3D image to yield the image data. "Image data" as used herein refers to the data generated or captured by an imaging device, including in a machine-readable form, a graphical form, and in any other form. In various examples, the image data may comprise data corresponding to an anatomical feature of the patient or a portion thereof and also data corresponding to the cannulation device or tool <NUM> for placement, insertion, and guidance of each tube of the plurality of tubes <NUM> during insertion. The imaging device <NUM> may be or comprise, for example, a fluoroscope, but may also be or comprise an ultrasound probe, an O-arm, a C-arm, a G-arm, or any other device utilizing X-ray-based imaging (e.g., a CT scanner, or other X-ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography scanner, an endoscope, a telescope, a thermographic camera (e.g., an infrared camera), or any other imaging device suitable for obtaining images or image data.

The navigation system <NUM> may provide navigation for a surgeon and/or a surgical robot during an operation. The navigation system <NUM> may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system. The navigation system <NUM> may include a camera or other sensor(s) for tracking one or more reference markers, navigated trackers, or other objects within the operating room or other room where a surgical procedure takes place. In various embodiments, the navigation system <NUM> may be used to track a position of the cannulation device or tool <NUM> (or, more particularly, of a navigated tracker attached, directly or indirectly, in fixed relation to the cannulation device or tool <NUM>). The navigation system <NUM> may additionally or alternatively be used to track a position of the robot <NUM> (or, more particularly, of a navigated tracker attached, directly or indirectly, in fixed relation to the robot <NUM>). The navigation system <NUM> may include a display for displaying one or more images from an external source (e.g., the computing device <NUM> or other source) or a video stream from a camera or other sensor of the navigation system <NUM>. In some embodiments, the system <NUM> can operate without the use of navigation system <NUM>.

The robot <NUM> may be any surgical robot or surgical robotic system. The robot <NUM> may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot <NUM> may comprise a robotic arm <NUM>. In some embodiments, the robotic arm <NUM> may comprise a plurality of robotic arms. For example, the robot <NUM> may comprise two robotic arms or more than two robotic arms. In some examples, the robotic arm <NUM> may hold the cannulation device or tool <NUM>. The robot <NUM> (or more particularly, the robotic arm <NUM>) may be operable to hold the cannulation device <NUM> in a first position and to utilize the cannulation device <NUM> while it is in the first position to make an incision in a patient, and then to move the cannulation device <NUM> to a second position and to hold the cannulation device <NUM> in the second position while each of the plurality of tubes is inserted into the incision. The robot <NUM> may enable each tube of the plurality of tubes <NUM> to be inserted at the same angle as the incision was made, thereby increasing accuracy of the placement of each tube and reducing trauma to the patient at the cannulation site.

Reference markers (i.e., navigation markers) may be placed on the robot <NUM>, the robotic arm <NUM>, the cannulation device or tool <NUM> or any other object in the surgical space. The reference markers may be tracked by the navigation system <NUM>, and the results of the tracking may be used by the robot <NUM> and/or by an operator of the system <NUM> or any component thereof. In some embodiments, the navigation system <NUM> can be used to track other components of the system <NUM> (e.g., a cannulation device or tool <NUM>, or a portion thereof) and the system <NUM> can operate without the use of the robot <NUM> (e.g., with the surgeon manually manipulating the cannulation device or tool <NUM>).

Turning now to <FIG>, an illustrative method <NUM> is shown to further the understanding of the inventive cannulation device, herein the illustrative method <NUM> for positioning a cannulation device may be executed, for example, in whole or in part, on a computing device such as the computing device <NUM> or a similar device, and more specifically on or by a processor such as the processor <NUM>. Execution of the illustrative method <NUM> may require or utilize one or more other components of the system <NUM> or similar components. One or more aspects of the illustrative method <NUM> may be performed by or with a surgical robot such as the robot <NUM>, a surgeon, or a combination of both.

The illustrative method <NUM> comprises moving an inner cannula such as the inner cannula 110A from a retracted position of a plurality of retracted positions to an extended position of a plurality of extended positions (step <NUM>). Cannulation device instructions such as the cannulation device instructions <NUM> may be used by a processor such as the processor <NUM> to cause cannulation device <NUM> to move the inner cannula from the retracted position to the extended position. The inner cannula may be moved by a gripper such as the gripper <NUM> when the gripper is in a first configuration. The moving may include using an oscillation rail such as the oscillation rail <NUM> to facilitate insertion of the inner cannula into the opening by causing a rotating, back-and-forth, vibration-like motion during movement of the gripper that helps to overcome the friction and resistance of tissue surrounding the opening. The inner cannula may comprise a protrusion such as the protrusion <NUM> on an outer surface thereof.

The illustrative method <NUM> also comprises moving each cannula of a set of cannulas such as the set of a cannulas <NUM> from a respective retracted position of the plurality of retracted positions to a respective extended position of the plurality of extended positions (step <NUM>). The cannulation device instructions may be used by the processor to cause each cannula of the set of cannulas to move from the retracted position to the extended position. Each cannula may be moved by the gripper when the gripper is in the first configuration (e.g., in one of a plurality of extension positions or first configurations). Each cannula may have a groove such as the groove <NUM> on an inner surface thereof that receives a protrusion such as the protrusion <NUM> of an adjacent cannula or the protrusion of the inner cannula when the adjacent cannula reaches its respective extended position of the plurality of extended positions. When the protrusion is received by the corresponding groove, the adjacent cannulas are removably engaged to each other.

The illustrative method <NUM> also comprises moving an outer cannula such as the outer cannula 110B from its respective retracted position of the plurality of retracted positions to its respective extended position of the plurality of extended positions (step <NUM>). The cannulation device instructions may be used by the processor to cause the outer cannula to move from the retracted position to the extended position. The outer cannula may be moved by the gripper when the gripper is in the first configuration.

The illustrative method <NUM> also comprises retracting the inner cannula and the set of cannulas (step <NUM>). The cannulation device instructions may be used by the processor to cause the inner cannula and the set of cannulas to move from the extended position to the retracted position. The inner cannula and the set of cannulas may be moved by the gripper when the gripper is in the second configuration. The outer cannula remains in the opening to keep the opening open and to provide a clear path for a surgical tool to pass through the opening. In some embodiments of the inventive cannulation device, the outer cannula comprises a first portion such as the first portion <NUM> and a second portion such as the second portion <NUM>. In case of such embodiments, the retracting retracts the inner cannula, the set of cannulas, and the first portion, but leaves the second portion in the opening.

The illustrative method <NUM> may comprise receiving a surgical plan, which may be the same as or similar to the surgical plan <NUM>. The surgical plan may be received via the user interface and/or the communication interface, and may be stored in the memory. The surgical plan may include information about one or more planned movements (e.g., one or more trajectories) of the cannulation device held by a robotic arm such as the robotic arm <NUM> during a surgical procedure. The information may also include a timeline or schedule of the one or more planned movements. The one or more planned movements may include one or more of timestamps, a type of movement (e.g., translational and/or rotational), a duration of the movement, and/or positional information (e.g., coordinates and/or orientation).

The illustrative method <NUM> may comprise determining information about one or more needed movements (including, for example, one or more trajectories) of the cannulation device or other tool during a surgical procedure outlined or otherwise described in a surgical plan. In such cases, the surgical plan may not include receiving any such information via a computing device, but a processor, executing instructions stored in a memory, may generate such information based on the surgical plan.

The inventive systems described herein provide a cannulation device having a plurality of tubes that are each moveable from one of a plurality of retracted positions to one of a plurality of extended positions. By having each tube, except for an outer tube, nested and removably engaged to each other and automatically inserted, the plurality of tubes are compactly held together as one unit and the process for the insertion of each tube is streamlined. In other words, each tube does not need to be manually added to the cannulation site, which may increase overall operating time and complexity. Further, the cannulation device improves the accuracy of placement of the cannulas and reduces or eliminates additional movements caused by adding cannulation tubes to the site manually. Thus, systems, and devices for placing a cannula provide for a streamlined process with improved accuracy for insertion of the cannula into a patient.

As may be appreciated based on the foregoing disclosure, for furthering the understanding of the inventive cannulation device the present disclosure describes the illustrative methods with fewer than all of the steps identified in <FIG> (and the corresponding description of the illustrative method <NUM>), as well as illustrative methods that include other and/or additional steps beyond those identified in <FIG> (and the corresponding description of the illustrative method <NUM>). For example, the illustrative method <NUM> may comprise only one, or only two, of the steps <NUM>, <NUM>, and <NUM>. Illustrative methods of the present disclosure explicitly include illustrative methods with one or more steps described above as part of the illustrative method <NUM>.

The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

Moreover, though the description has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claim 1:
A cannulation tool (<NUM>) comprising:
a body (<NUM>);
a plurality of tubes (<NUM>) removably secured to the body (<NUM>), each tube (<NUM>) moveable from a retracted position to an extended position, the plurality of tubes (<NUM>) including an inner tube (<NUM>10A), an outer tube (110B), and a set of tubes (<NUM>) positioned between the inner tube and the outer tube, each tube (110C, 110D, 110E) of the set of tubes (<NUM>) nested in an adjacent tube, the outer tube (110B) positioned external to the set of tubes (<NUM>), and the inner tube (110A) positioned internal to the set of tubes (<NUM>),
characterized in that
a gripper rod (<NUM>) having a gripper (<NUM>) is disposed on a gripper first end (<NUM>) thereof for forcibly moving each tube of the set of tubes (<NUM>), in sequence, from the retracted position to the extended position,
a pair of arms (<NUM>) are disposed at the gripper first end (<NUM>), wherein each arm of the pair of arms (<NUM>) comprises a primary arm (<NUM>) and a secondary arm (<NUM>), wherein the primary arms (<NUM>) form a first set of gripper arms (<NUM>) when the gripper (<NUM>) is in any one of a plurality of first configurations, and the secondary arms (<NUM>) form a second set of gripper arms (<NUM>) when the gripper (<NUM>) is in a second configuration, wherein the first set of gripper arms (<NUM>) is operable to move in sequence from one of the plurality of first configurations to another of the plurality of first configurations so as to successively move each tube of the plurality of tubes (<NUM>) from a corresponding retracted position to a corresponding extended position, and wherein the second set of gripper arms (<NUM>) is operable to move the inner tube (110A) and the plurality of tubes (<NUM>) back to a retracted position when the gripper (<NUM>) is in the second configuration.