Cannula insertion device, system and method

Abstract

A cannula insertion tool and system and method for placing a cannula are provided. The tool includes a main body and a plurality of tubes (110) removably secured to the main body. Each tube is movable from a retracted position to an extended position. The plurality of tubes can include an inner tube (110A), an outer tube (110B), and a set of tubes (110C, 110D, 110E) positioned between the inner tube and the outer tube. Each tube in the set of tubes is nested in an adjacent tube, the outer tube is positioned outside the set of tubes, and the inner tube is positioned inside the set of tubes. The tool further includes a gripper bar (118) having a gripper disposed on an end thereof for forcibly moving each tube in the set of tubes from the retracted position to the extended position in sequence.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application 63 / 064,530, filed August 12, 2020, entitled “Cannulation Devices, Systems, and Methods,” which is incorporated herein by reference in its entirety. Technical Field

[0003] This technology relates in general to cannula insertion tubes and their use, and more specifically to inserting multiple cannula insertion tubes into an opening. Background Technology

[0004] A cannula is used to create and produce an open access tube within a patient for the removal or insertion of fluids, samples, or instruments. Cannulas can be placed manually by incising the skin and inserting a progressively larger dilator, and their placement depends on the type of surgery being performed. Cannulas can be positioned and left in place for short or long periods. Summary of the Invention

[0005] Exemplary aspects of this disclosure include:

[0006] A cannula insertion tool according to at least one embodiment of the present disclosure includes: a body; a plurality of tubes removably secured to the body, each tube being movable 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 and outer tubes, each tube in the set of tubes nested within an adjacent tube, the outer tube positioned outside the set of tubes, and the inner tube positioned inside the set of tubes; and a clamping rod having a clamp disposed at its end for sequentially and forcibly moving each tube in the set of tubes from the retracted position to the extended position.

[0007] In any aspect of this article, each of the inner tube and a set of tubes includes a protrusion on its outer surface, each protrusion being configured to engage a groove on the inner circumference of an adjacent tube.

[0008] Any aspect of this article also includes a motor configured to selectively extend and retract the gripper lever.

[0009] Any aspect of this article also includes an oscillating track mounted to the body, which causes the gripper lever to oscillate during extension or retraction movements.

[0010] In any aspect of this article, the clamp moves the outer tube from the retracted position to the extended position.

[0011] In any aspect of this article, the clamp moves the inner tube from the retracted position to the extended position.

[0012] In any aspect of this article, the gripper is reconfigurable from a first configuration to a second configuration, and the gripper is operable to retract both a set of tubes and an inner tube when the gripper is in the second configuration.

[0013] In any aspect of this article, the clamp is biased toward the second configuration.

[0014] In any aspect of this article, the inner tube includes a pin on its inner surface, and further wherein the clamp is configured to clamp the pin when the clamp is in a second configuration to retract the plurality of tubes.

[0015] In any aspect of this article, the outer tube is configured to remain in the extended position when both the set of tubes and the inner tube are retracted.

[0016] In any aspect of this document, the outer tube includes a first portion and a second portion, the first portion being configured to separate from the second portion and remain in the extended position when the second portion is retracted.

[0017] In any aspect of this article, the body includes a first end and a second end, the tool further includes: a blade positioned at the first end and operable to cut through soft tissue, and a plurality of tubes positioned at the second end.

[0018] Any aspect of this article, wherein the inner tube includes a tapered end.

[0019] A cannula insertion system according to at least one embodiment of the present disclosure includes: a surgical tool having: a body; a plurality of tubes removably secured to the body, each tube being movable 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 and outer tubes, each tube in the set of tubes nested within an adjacent tube, the outer tube positioned outside the set of tubes, and the inner tube positioned inside the set of tubes; and a gripper lever having a gripper disposed at its end; at least one processor; and at least one memory storing instructions executable by the at least one processor, the instructions, when executed, causing the at least one processor to: cause the gripper to sequentially move each tube in the set of tubes from the retracted position to the extended position, and cause the gripper to simultaneously move the set of tubes from the extended position to the retracted position.

[0020] In any aspect of this article, each of the inner tube and a set of tubes includes a protrusion on its outer surface, each protrusion being configured to engage a groove on the inner circumference of an adjacent tube.

[0021] Any aspect of this article also includes a motor configured to selectively extend and retract the gripper lever.

[0022] Any aspect of this article also includes an oscillating track mounted to the body, which causes the gripper lever to oscillate during extension or retraction movements.

[0023] In any aspect of this article, the gripper is reconfigurable from a first configuration to a second configuration, and the gripper is operable to retract a set of tubes when the gripper is in the second configuration.

[0024] In any aspect of this article, the clamp is biased toward the second configuration.

[0025] In any aspect of this document, at least one memory stores additional instructions for execution by at least one processor, which, when executed, further cause at least one processor to: move an inner tube from a retracted position to an extended position using a gripper, and move the inner tube and a set of tubes simultaneously from the extended position to the retracted position using a gripper, wherein the inner tube includes a pin on its inner surface, and further wherein the gripper is configured to grip the pin when the gripper is in a second configuration to retract the inner tube and the set of tubes.

[0026] In any aspect of this document, at least one memory stores additional instructions for execution by at least one processor, which, when executed, further cause at least one processor to: move the gripper from a retracted position to an extended position, and wherein the outer tube is configured to remain in the extended position when a set of tubes is retracted.

[0027] A method for placing a sleeve according to at least one embodiment of the present disclosure includes: moving a first sleeve from a first retracted position to a first extended position using a clamp, the first sleeve including a knob on its outer surface; moving a second sleeve from a second retracted position to a second extended position using a clamp, the second sleeve having a groove on its inner surface receiving the knob of the first sleeve when the second sleeve reaches the second extended position; moving a third sleeve from a third retracted position to a third extended position using a clamp; and retracting the first and second sleeves by engaging the clamp with a pin extending from the first sleeve and retracting the clamp, the engagement of the knob with the groove causing the second sleeve to retract together with the first sleeve.

[0028] In any aspect of this article, the knob is a first knob, the groove is a first groove, the second sleeve includes a second knob on its outer surface, and the method further includes: using a clamp to move a fourth sleeve from a fourth retracted position to a fourth extended position, the fourth sleeve having a second groove on its inner surface, the second groove receiving the second knob of the second sleeve when the fourth sleeve reaches the fourth extended position.

[0029] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the technology described in this disclosure will be apparent from the specification, drawings, and claims.

[0030] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that possess both connective and disjoint qualities in operation. For example, the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” mean only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element such as X, Y, and Z, or such as X1-X… n Y1-Y m and Z1-Z o When referring to a single class of elements, the phrase means a single element selected from X, Y, and Z; a combination of elements selected from the same class (e.g., X1 and X2); or elements selected from two or more classes (e.g., Y1 and Z). o () combination.

[0031] The term "a / an" refers to one or more of the entities mentioned. Thus, the terms "a / an," "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising / including" and "having" are used interchangeably.

[0032] The foregoing is a simplified overview of this disclosure to provide an understanding of some aspects thereof. This summary is neither a broad nor an exhaustive overview of this disclosure and its various aspects, embodiments, and configurations. It is not intended to identify key or essential elements of this disclosure, nor to depict its scope, but rather to present selected concepts in a simplified form as an introduction to the more detailed description presented below. It should be understood that other aspects, embodiments, and configurations of this disclosure may utilize one or more of the features set forth above or described in detail below, individually or in combination.

[0033] Many additional features and advantages of the invention will become apparent to those skilled in the art upon consideration of the embodiments described below. Attached Figure Description

[0034] The accompanying drawings are incorporated in and form part of this specification to illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings illustrate only preferred and alternative examples of how to carry out and use this disclosure, and should not be construed as limiting this disclosure to the examples shown and described only. Additional features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated by the figures referenced below.

[0035] Figure 1A An image of a cannula insertion device in a first position according to at least one embodiment of the present disclosure;

[0036] Figure 1B for Figure 1A Image of the cannula insertion device in the second position;

[0037] Figure 2A Images of a gripper and associated structures according to at least one embodiment of this disclosure;

[0038] Figure 2B To show in detail Figure 1B Image of the gripper;

[0039] Figure 3A An image of a portion of a cannula insertion device according to at least one embodiment of the present disclosure;

[0040] Figure 3B An image of a portion of a cannula insertion device according to at least one embodiment of the present disclosure, including a detailed view of that portion;

[0041] Figure 3C To show in detail Figure 3B Images of multiple tubes of a cannula insertion device, including detailed views of a portion thereof;

[0042] Figure 4A An image of one of a plurality of cannula insertion tubes according to at least one embodiment of the present disclosure;

[0043] Figure 4B Images showing a portion of a cannula insertion device according to at least one embodiment of the present disclosure;

[0044] Figure 4C An image of a cannula insertion device according to at least one embodiment of the present disclosure;

[0045] Figure 5A An image of a portion of a cannula insertion device according to at least one embodiment of the present disclosure;

[0046] Figure 5BAn image of a portion of a cannula insertion device according to at least one embodiment of the present disclosure;

[0047] Figure 6 This is a block diagram of a system according to at least one embodiment of the present disclosure; and

[0048] Figure 7 A flowchart of a method according to at least one embodiment of this disclosure. Detailed Implementation

[0049] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example or embodiment, certain actions or events of any of the processes or methods described herein may be performed in different sequences, and / or may be added, combined, or omitted entirely (e.g., depending on different embodiments of this disclosure, performing the disclosed technology may not require all the described actions or events). Furthermore, for clarity, although some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, computing devices and / or medical devices.

[0050] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a non-transitory computer-readable medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0051] Instructions can 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 microprocessor), application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique can be fully implemented in one or more circuit or logic elements.

[0052] Before explaining any embodiment of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. This disclosure can have other embodiments and can be practiced or carried out in various ways. Similarly, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including / comprising” or “having” and variations thereof herein is intended to cover items listed thereafter and their equivalents, as well as additional items. Furthermore, this disclosure may use examples to illustrate one or more aspects thereof. Unless otherwise expressly stated, the use or listing of one or more examples (which may be indicated by “for example,” “by means of an example,” “e.g.,” “such as,” or similar language) is not intended to, and does not limit, the scope of this disclosure.

[0053] In some cases of minimally invasive surgery, endoscopy, or certain surgical procedures, creating an open tube access point can be beneficial, which can be accomplished by placing a cannula. Cannulas can be placed manually by incising the skin and generating linear and torque movements, or by inserting a gradually increasing size dilator using a mechanical separator. Cannula placement requires accuracy and can be time-consuming. Achieving the required accuracy often involves significant radiation exposure for both the patient and the surgical team, as radiation-based imaging is used to ensure proper cannula placement. Furthermore, the cannula placement procedure can be time-intensive, and surgeon fatigue can impact performance and operation time later in the surgical process.

[0054] This disclosure provides an electrically powered cannula insertion system for rapidly, automatically, and accurately establishing an endoscopic inlet or placing a tubular retractor without excessive radiation exposure. The system can be an electromechanical unit or robotic system mounted on a rigid base, employing a controlled combination of skin cutting and linear and oscillatory motion to insert a progressively enlarging dilator. The robotic system can position the cannula insertion system at the desired location and orientation based on a planned trajectory or path. The cannula insertion system performs skin cutting, inserts a guide pin, and places the progressively enlarging cannula on the guide while performing slight oscillatory rotational motions during insertion. The inner cannula is removed when the desired cannula width is reached.

[0055] Embodiments of this disclosure provide a cannula insertion system employing a novel mechanism to support the described functions. This novel mechanism includes, for example, a single motor and components with small form factors, such as a torsional cam follower for oscillating motion, a scissor-like gripper with a dual function of clamping each cannula and removing internal mechanisms, and a progressively enlarging side knob that allows cannula insertion one at a time during the insertion phase. By controlling the speed, force, and linear advance of the system, the process can be pre-planned to achieve the desired results without human intervention. The system provides greater automation for percutaneous and minimally invasive procedures, which will improve surgical safety and efficiency, while also simplifying training, reducing surgeon fatigue, and saving time.

[0056] As described more fully below, methods, systems, and devices for inserting cannulas can advantageously reduce operation time by providing a streamlined, automated process. Cannula insertion devices can also improve the accuracy of device placement and thereby reduce trauma to the surrounding patient area.

[0057] First turn Figure 1A and Figure 1BA cannula insertion tool or cannula insertion device 100 is shown. The cannula insertion tool or device 100 includes a plurality of tubes 110, each tube being movable from one of a plurality of retracted positions to one of a plurality of extended positions. Prior to use, the plurality of tubes 110 are held in the retracted position at a base 120. In the illustrated embodiment, the plurality of tubes 110 includes an inner tube 110A, an outer tube 110B, and a set of tubes 122. In the illustrated embodiment, the set of tubes includes three tubes 110C, 110D, and 110E positioned between the inner tube 110A and the outer tube 110B. In other embodiments, the set of tubes 122 includes fewer or more than three tubes. The number of tubes in the set of tubes may be based on the desired size of the opening. Each tube in the set of tubes 122 is nested within an adjacent tube. The tube 110 may be made of stainless steel, polyetheretherketone (PEEK) or any other metal, metal alloy, plastic, composite material or other material that has sufficient rigidity to maintain its shape during and after insertion into the body and has biocompatibility that enables its use in the patient during surgical procedures.

[0058] In the illustrated embodiment, a plurality of tubes 110 are disposed on a body 102 having a first end 104 and a second end 106. The body 102 may be in the form of a plate with an extension 103, as shown, or may be any other form or shape, including but not limited to cylindrical, box-shaped, elliptical, circular, rectangular, etc. When the body 102 is in a first position, the first end 104 may be positioned near the patient's skin, and when the body 102 is in a second position, the second end 106 may be positioned near the patient's skin. The body 102 may rotate or otherwise move between the first and second positions. The plurality of tubes 110 may be positioned at the second end 106, and a blade 108 may be positioned at the first end 104. When the body 102 is in the first position, the blade 108 is operable to make an incision or opening in the skin.

[0059] The tool or device 100 may also include a clamp 200 having a clamp 200 disposed on a first end 202 of the clamp (in Figure 2A and Figure 2B The clamping lever 118 (shown in detail below) is a gripper. The gripper 200 is configured to sequentially and forcibly move each of the plurality of tubes 110 from a corresponding retracted position to a corresponding extended position, from the inner tube 110A to the outer tube 110B. The tool or device 100 may also include a motor 112 operatively connected to the clamping lever 118 and configured to selectively extend and retract the clamping lever 118. Figure 1BAs indicated, motor 112 is mounted on extension 103 and rotates shaft 111 with external threads, which engages with internal threads of bracket 113. The second end 204 of the gripper rod 118 (in...) Figure 2A (See image) is connected to bracket 113. Bracket 113 is also connected to a linear track 115 adjacent to and parallel to shaft 111, which helps keep bracket 113 substantially perpendicular to shaft 111. Due to the threaded engagement of shaft 111 with bracket 113, rotation of shaft 111 causes bracket 113 to move along shaft 111 and linear track 115. The second end 204 of gripper rod 118 is rotatably connected to bracket 113 such that movement of bracket along shaft 111 in the length dimension also causes movement of gripper rod 118 in the same dimension. In some embodiments, tool or device 100 may not include motor 112, but may include a connector or other connection to which an external motor is operatively attached. Motor 112 may be an electric motor, linear induction motor, pneumatic motor, hydraulic motor, geared motor, AC brushless motor, DC brushed motor, DC brushless motor, servo motor, etc., having a rotor and stator.

[0060] The tool or device 100 may also include an oscillating track 114 that causes the gripper lever 118 (and thus the gripper 200) to oscillate during extension or retraction movements (e.g., movements along a length dimension parallel to axis 111). The oscillating track 114 is positioned parallel to axis 111. A cam follower 116 disposed on the second end 204 of the gripper engages the oscillating track 114, which forces the cam follower 116 (and thus the gripper lever 118) from side to side as the support 113 moves up and down along axis 111. This oscillating motion produces a vibratory motion that helps insert each of the plurality of tubes 110 into the opening by helping to overcome friction and resistance of the tissue surrounding the opening. Furthermore, the oscillating track 114 allows for the use of a smaller motor, as less power is required to insert each tube.

[0061] Turning Figure 2A and Figure 2B A close-up of the gripper lever 118 and the gripper 200 is shown. The gripper 200 includes a gripper lever 118 extending from a first end 202 of the gripper to a second end 204 of the gripper. A cam follower 116 is disposed at the second end 204 of the gripper, and a pair of arms 208 are disposed at the first end 202 of the gripper. Each of the pair of arms 208 includes a main arm 212 and a secondary arm 214. When the gripper 200 is in multiple extended positions or a first configuration (including...), the gripper lever 118 extends from a first end 202 to a second end 204 of the gripper. Figure 2AIn any of the extended positions or first configurations shown, the main arm 212 forms the first set of gripper arms 206, and when the gripper 200 is in the retracted position or second configuration (as shown), the main arm 212 forms the first set of gripper arms 206. Figure 2B When the first set of gripper arms 206 is in the retracted position or second configuration (as shown in the diagram), the secondary arm 214 forms a second set of gripper arms 210. The first set of gripper arms 206 is operable to sequentially move from one of a plurality of extended positions or first configurations to another of a plurality of extended positions or first configurations (each successive position or configuration is defined by a slightly larger distance between the ends of the main arm 212) to sequentially move each of the plurality of tubes 110 from its corresponding retracted position to its corresponding extended position. When the gripper 200 is in the retracted position or second configuration, the second set of gripper arms 210 is operable to move the inner tube 110A and a set of tubes 122 back to the retracted position. As shown in the illustrated embodiment, the length of the secondary arm 214 is shorter than that of the main arm 212. In other embodiments, the length of the secondary arm 214 may be longer than that of the main arm 212, or the length of the secondary arm 214 may be the same as that of the main arm 212.

[0062] A pair of arms 208 are biased to a retracted position or a second configuration. In some embodiments, the pair of arms 208 may be biased by a spring (such as a leaf spring, helical spring, torsion spring, etc.). In the illustrated embodiment, the pair of arms 208 are biased by a torsion spring 216. In other embodiments, part or all of the pair of arms 208 may be formed of an elastic material to bias the pair of arms 208 to the retracted position or the second configuration. Figure 3A and Figure 3BAs shown, a pair of arms 208 can be held (or caused to move) by a retainer 304 to one of a plurality of extended positions or a first configuration. The retainer 304 can be a tab, a rod, etc. In the illustrated embodiment, the retainer 304 prevents the gripper 200 from moving to the retracted position or the plurality of pins in the second configuration by preventing rotation of the pair of arms 208. In the illustrated embodiment, the first pair of pins of the retainer 304 is positioned closer to the plurality of tubes 110, and the second pair of pins is positioned above the first pair of pins (e.g., on the side of the first pair of pins opposite to the plurality of tubes 110). The first pair of pins is spaced further apart than the second pair of pins such that when the gripper rod 118 is fully retracted to pull the gripper 200 into the retainer 304, the pair of arms 208 first contacts the first pair of pins, which counteracts the biasing force of the torsion spring 216 and pushes the pair of arms 208 into the extended position or the first configuration. The protrusions or bumps in the outer contours of a pair of arms 208 (when in the extended position or the first configuration) are configured to engage a second pair of pins. The interaction between the second pair of pins and the outer contours of the pair of arms 208 causes the ends of the main arms 212 to move (against the biasing force of the torsion spring 216) even closer together. In other words, the first pair of pins brings the pair of arms 208 together into the second pair of pins, thereby closing the pair of arms 208. When the pair of arms 208 is not constrained, the pair of arms 208 moves to the retracted position or the second configuration.

[0063] Each of the plurality of tubes 110 includes a pair of opposing slots 306 on its inner circumference. The slots 306 are defined by the outer wall and bottom surface 308 of the tube and are wide enough (circumferentially) to receive the main arm 212 of the gripper 200. As the gripper 200 moves downward (e.g., by operation of the motor 112, which rotates the shaft 111 and moves the support 113 toward a set of tubes, thus also moving the gripper rod 118 and the gripper 200 in the same direction), the end of the main arm 212 contacts the bottom surface 308 of the slot 306 of the first inner tube 110A and pushes the inner tube 110A into an extended position. The motor 112 then reverses, moving the gripper 200 upward within the second tube 110C (which holds the gripper 200 in the extended position or the first configuration) until the gripper 200 reaches the slot 306 of the second tube 110C. When the gripper 200 reaches the slot 306 of the second tube 110C, the biasing force of the spring 216 pushes the ends of the main arms 212 away from each other until they contact the outer wall of the slot 306 (which is also the outer wall of the tube 110C). Then, the motor 112 reverses direction again, causing the gripper 200 to press against the bottom surface 308 of the slot 306 of the second tube 110C to push the second tube 110C into the extended position. The process then continues until the gripper 200 has pushed all the tubes 110 into the extended position.

[0064] Turning Figures 3A-3CThe diagram illustrates a plurality of tubes 110. As previously described, the plurality of tubes 110 includes an inner tube 110A, an outer tube 110B, and a set of tubes 112 (e.g., tubes 110C, 110D, 110E) between the inner tube 110A and the outer tube 110B. In the illustrated embodiment, the inner tube 110A includes a tapered end 310. The end 310 can facilitate insertion of the inner tube 110A into a cut or opening formed by the blade 108 (or otherwise), and can serve as a guide for each subsequent insertion of tubes from the plurality of tubes 110. In other embodiments, the inner tube 110A may include an end of any shape, such as an open tapered end, a blunt end, a flattened end, etc. In some embodiments, the end of the inner tube 110A may be configured to receive a guide needle that has been placed in the patient's body along the correct trajectory. In such embodiments, the inner tube 110A may be inserted onto the guide needle to ensure that the inner tube 110A is inserted along the correct trajectory.

[0065] As shown in the figure, the diameter of each of the plurality of tubes 110 increases from the inner tube 110A to the outer tube 110B. Each subsequent tube from the plurality of tubes 110 may also have a wedge-shaped lower or distal end to facilitate the expansion of the incision or opening into which the tube is inserted. During insertion, the incision or opening widens as each tube is inserted. Therefore, the number of tubes in the plurality of tubes 110 may be based on the desired size of the opening (which in turn may be based on the size of the surgical instruments used during the surgical procedure, which will be performed wholly or partially through the installed cannulas). In some embodiments, the plurality of tubes 110 may include two tubes, and in other embodiments, the plurality of tubes may include more than two tubes 110.

[0066] Each of the inner tube 110A and the set of tubes 122 includes a protrusion 300 positioned on its outer circumference, and each of the outer tube 110B and the set of tubes 122 includes a groove 302 formed on its inner circumference. In some embodiments, the wider the tube 110, the larger the corresponding protrusion 300. In other embodiments, each tube 110 may have a protrusion 300 of the same size. The protrusion 300 of one tube can be removably engaged with the groove 302 of an adjacent tube. Thus, the groove 302 of each tube having such a groove 302 is sized to receive the protrusion 300 of the tube or sleeve, which fits tightly against the interior of the tube having the groove 302. This engagement holds each of the plurality of tubes 110 in a retracted position until the holder 200 forcibly moves each tube to an extended position. The graded dimensions of the protrusions 300 (and the corresponding grooves 302) prevent the plurality of tubes 110 from moving as a single unit into the corresponding extended position, and alternatively allow one tube to be moved to the corresponding extended position at a time. This is because the force required to remove the smaller protrusion 300 from the smaller recess 302 is less than the force required to remove the larger protrusion 300 from the larger recess 302. Similarly, the protrusion 300 can also be removably engaged with the recess 302 to connect the pipe in the corresponding extension position to the adjacent pipe when the adjacent pipe moves to the corresponding extension position. When each pipe except the outer pipe 110B is connected to the adjacent pipe in the corresponding extension position, the inner pipe 110A and the set of pipes 122 can be removed from the opening as a unit, such as Figure 5B As shown in the image.

[0067] Turning Figure 4A and Figure 4B Detailed views of the outer tube 110B and the outer tube 110B removably coupled to the base 120 are shown. In some embodiments, the outer tube 110B includes a first portion 400 and a second portion 402 (e.g., Figure 5A(As shown in the diagram). In other embodiments, the outer tube 110B is a single piece. In embodiments where the outer tube 110B includes a first portion 400 and a second portion 402, the first portion 400 and the second portion 402 can be removably engaged with each other. In some embodiments, such engagement is created by a snap-fit ​​engagement between the first portion 400 and the second portion 402. In other embodiments, engagement is formed by a frictional engagement. In other embodiments, such engagement is achieved by a reusable adhesive (or, if the outer tube 110B is not intended for sterilization and reuse, by a non-reusable adhesive). In some embodiments, a surgeon or robot can forcibly detach the first portion 400 from the second portion 402. In further embodiments, one of the first portion 400 or the second portion 402 may have a protrusion, and the other of the first portion 400 or the second portion 402 may have a groove for receiving the protrusion. In other embodiments, an external retainer holds the first portion 400 and the second portion 402 and is operable to release the first portion 400.

[0068] The first portion 400 of the outer tube 110B includes a protrusion 404 that is removably engaged with a groove 406 formed in the base 120, such as Figure 4B As shown in detail, the removable engagement of the outer tube 110B with the base 120 holds the outer tube 110B in the retracted position until it is pushed out of the retracted position by the clamp 200. Furthermore, before any one of the multiple tubes 110 is moved from the retracted position, the outer tube 110B holds the multiple tubes 110 in the retracted position through the engagement between the outer tube 110B and the base 120 (and through the engagement of each inner tube with the adjacent tube via the protrusion 300 and the groove 302). The outer tube 110B can be moved from the retracted position to the extended position when the first portion 400 and the second portion 402 engage with each other.

[0069] Figure 4C A pair of arms 208 (e.g., a second set of arms 210) in a second configuration is shown. When the pair of arms 208 are in the second configuration, they can clamp a pin 408 protruding from the inner wall of the inner tube 110A and pull a first portion 400 of a set of tubes 122, the inner tube 110A, and the outer tube 110B from the opening, as described below. A spring 216 biases the pair of arms 208 to apply sufficient clamping force on the pin 408 so that the gripper 200 can pull the first portion 400 of the inner tube 110A, the set of tubes 122, and the outer tube 110B from the opening. When the plurality of tubes 110 are removed from the opening, the first portion 400 can disengage from or be caused to disengage from the second portion 402, such that the second portion remains in the opening.

[0070] Turning Figure 5Aand Figure 5B When the inner tube 110A, the set of tubes 122, and the outer tube 110B are all in the extended position, the protrusion 300 and the groove 302 of the tube 110 engage with each other again. Once the gripper 200 has been used to place the outer tube 110B in the opening and has been retracted, the spring 216 reconfigures the gripper 200 into the retracted position or the second configuration. When the gripper 200 extends toward the tube 110 again, the pair of arms 208, now in the retracted position or the second configuration, grip the pin 408 of the inner tube 110A. As a result, when the tool or device 100 is pulled away from the opening, the gripper 200 pulls the first portion 400 of the set of tubes 122, the inner tube 110A, and the outer tube 110B from the opening, thereby leaving the second portion 402 of the outer tube 110B in the cut or opening. The second portion 402 of the outer tube 110B remains in the opening to keep the passage to the surgical site open and thus provide a clean passage for the delivery or removal of fluids or samples or the insertion of surgical instruments or apparatus. The second portion 402 may remain in the opening during the procedure and / or may remain in the opening after the procedure has been completed.

[0071] Turning Figure 6 The diagram illustrates a block diagram of a system 600 according to at least one embodiment of the present disclosure. System 600 can be used to facilitate patient use of the cannula insertion device or tool 100. System 600 can additionally or alternatively be used to execute cannula insertion device instructions 616 and / or perform other aspects of any of the methods disclosed herein. System 600 includes a computing device 602, an imaging device 612, a navigation system 614, a robot 626, and / or the cannula insertion device or tool 100. Figure 6 The cannula insertion device 100 shown above is related to the above. Figures 1A-5B The described cannula insertion device 100 is the same as or substantially similar to that of system 600. Systems according to other embodiments of this disclosure may include more or fewer components than system 600. For example, system 600 may not include imaging device 612, navigation system 614, and / or robot 626. Embodiments of this disclosure may include more than one of any of the components of system 600, specifically including cannula insertion device 100, imaging device 612, robot 626, and / or robot arm 628.

[0072] The computing device 602 includes a processor 604, a memory 606, a communication interface 608, and a user interface 610. Other embodiments of the computing device according to this disclosure may include more or fewer components than the computing device 602.

[0073] The processor 604 of the computing device 602 may be any processor described herein or any similar processor. The processor 604 may be configured to execute instructions stored in the memory 606, which may cause the processor 604 to perform one or more computational steps using or based on data received from the robot 626 and / or the navigation system 614.

[0074] Memory 606 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible non-transitory memory used to store computer-readable data and / or instructions. Memory 606 may store information or data for performing any step of, for example, the method 700 described herein. Memory 606 may store, for example, one or more cannula insertion device instructions 616 and / or one or more surgical plans 618. In some embodiments, such instructions may be organized into one or more applications, modules, packages, layers, or engines. The instructions may cause processor 604 to manipulate data stored in memory 606 and / or received from robot 626 and / or navigation system 614.

[0075] The computing device 602 may also include a communication interface 608. The communication interface 608 may be used to receive image data or other information from external sources (such as imaging device 612, navigation system 614, robot 626, and in some embodiments, cannula insertion device or tool 100), and / or to transmit instructions, images, or other information to external systems or devices (e.g., another computing device 602, imaging device 612, navigation system 614, robot 626, and / or cannula insertion device or tool 100). The communication interface 608 may include one or more wired interfaces (e.g., USB port, Ethernet port, FireWire port) and / or one or more wireless interfaces (e.g., configured to transmit information via one or more wireless communication protocols (such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.)). In some embodiments, the communication interface 608 may be used to enable the device 602 to communicate with one or more other processors 604 or computing devices 602, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0076] The computing device 602 may also include one or more user interfaces 610. The user interface 610 may be or include a keyboard, mouse, trackball, display, television, touchscreen, headset, and / or any other device for receiving information from and / or providing information to the user. The user interface 610 may be used to: for example, receive user selections or other user input regarding moving the inner cannula from a retracted position to an extended position; receive user selections or other user input regarding moving each cannula in a set of cannulas from a corresponding retracted position to a corresponding extended position; receive user selections or other user input regarding moving the outer cannula from a retracted position to an extended position using a clamp; receive user selections or other user input regarding retracting the inner cannula and a set of cannulas; and / or display image data, device instructions 616, and / or surgical plans 618. In some embodiments, the user interface 610 may be used to allow surgeons or other users to modify plan 618 or other information displayed on or via the user interface 610. However, it should be understood that each of the aforementioned inputs may be automatically generated by system 600 (e.g., by processor 604 or another component of system 600) or received by system 600 from a source external to system 600. In some embodiments, user inputs such as those described above may be optional or unnecessary for the operation of the systems, apparatus, and methods described herein.

[0077] Although the user interface 610 is shown as part of the computing device 602, in some embodiments, the computing device 602 may utilize a user interface 610 housed separately from one or more other components of the computing device 602. In some embodiments, the user interface 610 may be located close to one or more other components of the computing device 602, while in other embodiments, the user interface 610 may be located away from one or more other components of the computing device 602.

[0078] Imaging device 612 may be operable to image the patient and / or cannula insertion device or tool 100 to generate images and / or image data. Imaging device 612 may be capable of capturing 2D or 3D images to generate image data. As used herein, “image data” refers to data generated or captured by the imaging device, including data in machine-readable form, graphical form, and any other form. In various examples, image data may include data corresponding to anatomical features of the patient or a portion thereof, and may also include data corresponding to the cannula insertion device or tool 100 used for placing, inserting, and guiding each of the plurality of cannulas 110 during insertion. Imaging device 612 may be or include, for example, a fluorescein microscope, but may also be or include 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 thermal imaging camera (e.g., an infrared camera), or any other imaging device that can be used to acquire images of the patient.

[0079] During operation, navigation system 614 can provide navigation for the surgeon and / or surgical robot. Navigation system 614 can be any navigation system currently known or developed in the future, including, for example, Medtronic StealthStation. TM S8 Surgical Navigation System. Navigation system 614 may include a camera or one or more other sensors for tracking one or more reference markers, navigation trackers, or other objects in the operating room or other rooms where surgery is performed. In various embodiments, navigation system 614 may be used to track the position of cannula insertion device or tool 100 (or more specifically, a navigation tracker directly or indirectly attached to cannula insertion device or tool 100 in a fixed relationship). Navigation system 614 may additionally or alternatively be used to track the position of robot 626 (or more specifically, a navigation tracker directly or indirectly attached to robot 626 in a fixed relationship). Navigation system 614 may include a display for displaying one or more images from an external source (e.g., computing device 602 or other sources) or video streams from the camera or other sensors of navigation system 614. In some embodiments, system 600 may operate without using navigation system 614.

[0080] Robot 626 can be any surgical robot or surgical robot system. Robot 626 can be, or includes, for example, Mazor X. TMA stealth robotic guidance system. Robot 626 may include a robotic arm 628. In some embodiments, robotic arm 628 may include multiple robotic arms. For example, robot 626 may include two or more robotic arms. In some examples, robotic arm 628 may hold one or more cannula insertion devices or tools 100. Robot 626 (or more specifically, robotic arm 628) may be operable to hold cannula insertion device 100 in a first position, and while the cannula insertion device is in the first position, to use the cannula insertion device 100 to form an incision in the patient, and then to move the cannula insertion device 100 to a second position and hold the cannula insertion device 100 in the second position as each of the plurality of tubes is inserted into the incision. Robot 626 may enable each of the plurality of tubes 110 to be inserted at the same angle as when the incision is formed, thereby increasing the accuracy of placement of each tube and reducing trauma to the patient at the cannula insertion site.

[0081] Reference markers (i.e., navigation markers) may be placed on robot 626, robotic arm 628, cannula insertion device or tool 100, or any other object in the surgical space. The reference markers may be tracked by navigation system 614, and the results of the tracking may be used by the operator of robot 626 and / or system 600 or any component thereof. In some embodiments, navigation system 614 may be used to track other components of system 600 (e.g., cannula insertion device or tool 100, or a portion thereof), and system 600 may be operated without the use of robot 626 (e.g., a surgeon manually manipulating cannula insertion device or tool 100).

[0082] Turn now Figure 7 A method 700 for positioning a cannula insertion device may be performed, for example, wholly or partially, on a computing device (such as computing device 602 or a similar device), and more specifically on or by a processor (such as processor 604). Execution of method 700 may require or utilize one or more other components or similar components of system 600. One or more aspects of method 700 may be performed by or using a surgical robot (such as robot 626), a surgeon, or a combination of both.

[0083] Method 700 includes moving an inner sleeve (such as inner sleeve 110A) from one of a plurality of retracted positions to one of a plurality of extended positions (step 702). A sleeve insertion device instruction (such as sleeve insertion device instruction 616) may be used by a processor (such as processor 604) to cause the sleeve insertion device 100 to move the inner sleeve from the retracted position to the extended position. When the gripper is in a first configuration, the inner sleeve may be moved by a gripper (such as gripper 200). The movement may include using an oscillating track (such as oscillating track 114) to facilitate insertion of the inner sleeve into the opening by generating a rotational, back-and-forth, or vibration-like motion during the movement of the gripper, which helps overcome friction and resistance of tissue surrounding the opening. The inner sleeve may include a protrusion, such as a protrusion 300 on its outer surface.

[0084] Method 700 further includes moving each sleeve in a set of sleeves (such as a set of sleeves 122) from a corresponding retracted position in a plurality of retracted positions to a corresponding extended position in a plurality of extended positions (step 704). A sleeve insertion device instruction may be used by a processor to move each sleeve in the set of sleeves from a retracted position to an extended position. Each sleeve may be moved by the gripper when the gripper is in a first configuration (e.g., in one of the plurality of extended positions or the first configuration). Each sleeve may have a groove (such as groove 302) on its inner surface that receives a protrusion (such as a protrusion 300 of an adjacent sleeve or a protrusion of an inner sleeve) when an adjacent sleeve reaches a corresponding extended position in its plurality of extended positions. When the protrusion is received by the corresponding groove, the adjacent sleeves are removably engaged with each other.

[0085] Method 700 further includes moving an outer sleeve (such as outer sleeve 110B) from a corresponding retracted position among its plurality of retracted positions to a corresponding extended position among its plurality of extended positions (step 706). A sleeve insertion device instruction may be used by the processor to move the outer sleeve from the retracted position to the extended position. When the gripper is in a first configuration, the outer sleeve may be moved by the gripper.

[0086] Method 700 also includes retracting the inner cannula and a set of cannulas (step 708). A cannula insertion device command can be used by the processor to move the inner cannula and the set of cannulas from an extended position to a retracted position. When the gripper is in the second configuration, the inner cannula and the set of cannulas can be moved by the gripper. The outer cannula remains in the opening to keep the opening open and provide a clear path for surgical instruments to pass through the opening. In some embodiments, the outer cannula includes a first portion (such as first portion 400) and a second portion (such as second portion 402). In such embodiments, retraction retracts the inner cannula, the set of cannulas, and the first portion, but leaves the second portion in the opening.

[0087] In some embodiments, method 700 may include receiving a surgical plan, which may be the same as or similar to surgical plan 618. The surgical plan may be received via a user interface and / or a communication interface and may be stored in memory. The surgical plan may include information about one or more planned movements (e.g., one or more trajectories) of a cannula insertion device held by a robotic arm (such as robotic arm 628) during surgery. This 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 the following: timestamps, movement type (e.g., translational and / or rotational movement), movement duration, and / or location information (e.g., coordinates and / or orientation).

[0088] In some embodiments, method 700 may include determining information regarding one or more desired movements (including, for example, one or more trajectories) of a cannula insertion device or other tool during a surgical procedure outlined in or otherwise described in the surgical plan. In such embodiments, the surgical plan may not include any such information received via a computing device, but a processor executing instructions stored in memory may generate such information based on the surgical plan.

[0089] The methods and systems described herein provide a cannula insertion device with multiple tubes, each capable of moving from one of a plurality of retracted positions to one of a plurality of extended positions. By nesting each tube (excluding the outer tube) within each other and enabling removable engagement and automatic insertion, the multiple tubes are compactly held together as a unit, and the insertion process for each tube is streamlined. In other words, each tube does not need to be manually added to the cannula insertion site, which could increase overall operation time and complexity. Furthermore, the cannula insertion device improves cannula placement accuracy and reduces or eliminates additional movement caused by manually adding the cannula insertion tube to the site. Therefore, the methods, systems, and devices for cannula placement provide a streamlined process with improved accuracy for cannula insertion into a patient.

[0090] As can be understood based on the above disclosure, this disclosure covers fewer than [number of steps]. Figure 7 The methods for all steps identified in the document (and the corresponding description of method 700), and covering Figure 7 Methods that include other and / or additional steps besides those identified in the description (and the corresponding description of method 700). For example, method 700 may include only one or two steps of steps 702, 704, and 706. The methods of this disclosure explicitly include methods having one or more steps as part of method 700 as described above.

[0091] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. In the foregoing specific embodiments, for the purpose of simplifying this disclosure, various features of this disclosure are grouped together in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. The approach of this disclosure should not be construed as reflecting an intention that the claims require more features than expressly recited in each claim. Rather, as reflected in the following claims, aspects of the invention lie in fewer than all the features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are hereby incorporated into this specific embodiment, wherein each claim exists independently as a separate preferred embodiment of this disclosure.

[0092] Furthermore, although the description has included descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure upon understanding it, for example, as may be within the skill and knowledge of one skilled in the art. It is intended to obtain the right to include alternative aspects, embodiments, and / or configurations to the permissible extent, including claimed alternatives, replacements, and / or equivalent structures, functions, scopes, or steps, regardless of whether such alternatives, replacements, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended for use with any patentable subject matter.

Claims

1. A cannula insertion tool, the cannula insertion tool comprising: main body; Multiple tubes are removably fixed to a body, each tube being movable from a retracted position to an extended position. The multiple tubes include an inner tube, an outer tube, and a set of tubes positioned between the inner tube and the outer tube. Each tube in the set of tubes is nested within an adjacent tube. The outer tube is positioned outside the set of tubes, and the inner tube is positioned inside the set of tubes. A clamping rod having a clamp disposed on its first clamping end for sequentially and forcibly moving each tube in the group of tubes from the retracted position to the extended position; A pair of arms disposed at a first end of the gripper, each of the pair of arms including a main arm and a secondary arm, wherein when the gripper is in any of a plurality of first configurations, the main arm forms a first set of gripper arms, and when the gripper is in a second configuration, the secondary arm forms a second set of gripper arms, wherein the first set of gripper arms is operable to move sequentially from one of the plurality of first configurations to another of the plurality of first configurations to move each of the plurality of tubes continuously from a corresponding retracted position to a corresponding extended position, and wherein when the gripper is in the second configuration, the second set of gripper arms is operable to move the inner tube and the plurality of tubes back to the retracted position.

2. The tool of claim 1, wherein the inner tube and each of the set of tubes includes a protrusion on its outer surface, each protrusion being configured to engage a groove on the inner circumference of an adjacent tube.

3. The tool of claim 1 further includes a motor configured to selectively extend and retract the gripper lever.

4. The tool of claim 1 further includes an oscillating track mounted to the body, the oscillating track causing the gripper lever to oscillate during extension or retraction movements.

5. The tool of claim 1, wherein the clamp moves the outer tube from the retracted position to the extended position.

6. The tool of claim 5, wherein the clamp moves the inner tube from the retracted position to the extended position.

7. The tool of claim 6, wherein the clamp is reconfigurable from a first configuration to a second configuration, and the clamp is operable to retract both the set of tubes and the inner tube when the clamp is in the second configuration.

8. The tool of claim 7, wherein the clamp is biased toward the second configuration.

9. The tool of claim 8, wherein the inner tube includes a pin on its inner surface, and further wherein the clamp is configured to clamp the pin when the clamp is in the second configuration to retract the plurality of tubes.

10. The tool of claim 7, wherein the outer tube is configured to remain in the extended position when both the set of tubes and the inner tube are retracted.

11. The tool of claim 7, wherein the outer tube comprises a first portion and a second portion, the first portion being configured to separate from the second portion and remain in the extended position when the second portion is retracted.

12. The tool of claim 1, wherein the body comprises a first end and a second end, and the tool further comprises: A blade, positioned at the first end and operable to cut through soft tissue, and the plurality of tubes positioned at the second end.

13. The tool of claim 1, wherein the inner tube includes a tapered end.

14. A cannula insertion system, the cannula insertion system comprising: The tool as described in any one of claims 1-13; At least one processor; as well as At least one memory, the at least one memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: The clamp moves each tube in the group of tubes sequentially from the retracted position to the extended position, and The clamp simultaneously moves the set of tubes from the extended position to the retracted position.

15. The system of claim 14, wherein the gripper is reconfigurable from a first configuration to a second configuration, and the gripper is operable to retract the set of tubes when the gripper is in the second configuration.

16. The system of claim 15, wherein the clamp is biased toward the second configuration.

17. The system of claim 15, wherein the at least one memory stores additional instructions to be executed by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The clamp moves the inner tube from the retracted position to the extended position, and The clamp moves the inner tube and the set of tubes simultaneously from the extended position to the retracted position. The inner tube includes a pin on its inner surface, and further wherein the clamp is configured to clamp the pin when the clamp is in the second configuration to retract the inner tube and the set of tubes.

18. The system of claim 14, wherein the at least one memory stores additional instructions to be executed by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The clamp moves the outer tube from the retracted position to the extended position, and The outer tube is configured to remain in the extended position when the set of tubes is retracted.

Images