Suturing devices and related methods

Abstract

Medical devices and methods include a needle tip and needle body that releasably secure together via a coupling including a shaft and cavity. The coupling can include at least one of a detent or interference fit.

Description

Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC SUTURING DEVICES AND REEATED METHODSCROSS-REFERENCE TO REEATED APPEICATION

[0001] This application claims the priority benefit of U.S. Provisional Application No.63 / 752,316, filed January 31, 2025, which is hereby incorporated by reference herein in its entirety.MELI)

[0002] Disclosed embodiments relate to needles for suturing systems.BACKGROUND

[0003] Sutures are used in a variety of surgical and other applications, such as closing ruptured or incised tissue, soft tissue attachment, attachment of grafts, etc. Additionally, sutures may have other medical and / or non-medical uses. Conventionally, suturing is accomplished by penetrating tissue with the sharpened tip of a suturing needle that has a thread of suturing material attached to the opposite blunt end of the needle. The needle is then pulled through the tissue, causing the attached thread of suturing material to follow the path of the needle. Typically, a knot is tied at the trailing end of the thread to anchor the first stitch. This action is performed repetitively with application of tension to the needle to pull a length of the thread through the tissue using subsequent stitches until the tissue is sutured as desired with one or more stitches.

[0004] While the above-described suturing process can be performed manually, automated suturing systems also exist. Endosuturing devices are designed to suture tissue from within an organ (e.g., suture a plication line in the stomach tissue). Due to the environment, endosuturing devices can be difficult to operate with complex control of multiple endosuturing components. Additionally, many endosuturing devices utilize curved needles that pass along a curved path when passing through tissue.SUMMARY

[0005] The following presents a simplified summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.

[0006] In accordance with a first example, a medical device is described that includes an arcuate needle that includes a needle body and a needle tip. The needle body and the needle tip are configured to releasably couple together via a coupling including a shaft and cavity. A detent of the coupling is configured to hold the shaft and cavity together and includes a notch, a catch, and a flexure member configured to resiliently deform and subsequently insert the catch into the notch when the needle body and needle tip are fully coupled together.

[0007] In some examples, the shaft includes a ramp to deform the flexure member while the shaft is being inserted into the cavity. In further examples, an angle of a retention surface of notchIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC is steeper than an angle of the ramp. In further examples, an engagement surface of the catch and a retention surface of the notch disposed adjacent to the ramp are misaligned. For example, one of the engagement surface or the retention surface is curved and the other of the engagement surface or the retention surface is planar.

[0008] Any of the above examples can include one or more of the following aspects: the flexure member can be a portion of a wall at least partially defining the cavity, the needle tip can define the cavity, the catch, and the flexure member and the needle body includes the shaft defining the notch; the cavity and the shaft can include one or more corresponding engagement features to resist relative rotation when the shaft is inserted into the cavity; or the flexure member can be an elastomer. In this latter example, the needle tip can define the cavity and include the catch extending into the cavity and the needle body can include the shaft, the shaft having a base, the flexure member coupled to the base, and an engagement member coupled to the flexure member, the engagement member defining the notch.

[0009] In some examples, the shaft includes a main portion and the flexure member, the flexure member angled away from the main portion as the flexure member extends main portion, and notch is defined in a sidewall defining the cavity. In further examples, the flexure member extends at a plurality of angles relative to the main portion of the shaft; the catch is a distal end of the flexure member and the notch is defined in the sidewall of defining the cavity adjacent to an end thereof; and / or the flexure member includes a protrusion sized to be at least partially received within the notch.

[0010] Any of the above examples can include one or more of the following aspects: the flexure member is welded to the main portion of the shaft; the needle tip defines the cavity and notch, and the needle body includes the shaft including the flexure member with the catch at a distal end thereof; and / or the cavity and the shaft include one or more corresponding engagement features to resist relative rotation when the shaft is inserted into the cavity.

[0011] In accordance with a second example, a method for operating a suturing device is disclosed that includes assembling an arcuate needle by inserting a shaft into a cavity to connect a needle tip and needle body together, deforming a flexure member of a detent as the shaft is inserted into the cavity, and inserting a catch of the detent into a notch with the flexure member to secure the needle tip to the needle body.

[0012] In some examples, deforming the flexure member includes driving the catch up a ramp of the shaft as the shaft is inserted into the cavity. In further examples, inserting the catch of the detent into the notch includes the flexure member resiliently returning to shape to insert the catch into the notch disposed adjacent to the ramp.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0013] Any of the above examples can include one or more of the following aspects: deforming the flexure member includes flexing a portion of a wall at least partially defining the cavity outwardly as the shaft is inserted into the cavity; deforming the flexure member includes deforming an elastomer of the shaft, the shaft comprising the notch coupled to the elastomer; or the method includes securing a thread to the needle tip through a suture opening defined therethough. In this latter example, the method can further include disconnecting the needle tip from the needle body.

[0014] In some examples, deforming the flexure member includes deflecting the flexure member towards a main body of the shaft as the shaft is inserted into the cavity. In further examples, inserting the catch of the detent into the notch includes the flexure member resiliently returning to shape away from the main body of the shaft to insert the catch into the notch defined in a sidewall of the cavity. In yet further examples, inserting the catch of the detent into the notch includes inserting a lip of the flexure member into the notch.

[0015] In some examples, the method includes securing a thread to the needle tip through a suture opening defined therethough. In further examples, the method includes disconnecting the needle tip from the needle body.

[0016] In accordance with a third example, a medical device is described that includes an arcuate needle including a needle body and a needle tip, where the needle body and the needle tip are configured to releasably couple together via a coupling including a shaft and cavity. The medical device further includes one or more tapered friction surfaces of the coupling that are configured to result in increasing forces as the shaft is inserted into the cavity.

[0017] In some examples, the shaft has a forked configuration with interior surfaces tapered to reduce spacing therebetween and the coupling includes a bar extending across the cavity, the interior surface of the shaft configured to engage the bar when the shaft is inserted into the cavity.

[0018] In some examples, the shaft includes an annular protrusion extending therearound, the protrusion having a rearwardly tapered surface configured to engage an interior surface of the cavity when the shaft is inserted into the cavity.

[0019] In the above examples, the needle tip can define the cavity and the needle body can include the shaft. In further examples, the needle tip defines one or more recesses adjacent to the cavity such that the coupling is tolerant of debris.

[0020] In accordance with a fourth example, a medical device is described that includes an arcuate needle including a needle body and a needle tip, where the needle body and the needle tip are configured to releasably couple together via a friction fit coupling. A detent of the coupling is configured to hold the shaft and cavity together, where the detent includes one or more barsIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC extending at least partially into an interior of the cavity and a contoured surface of the shaft configured to engage the one or more bars to hold the needle body and needle tip together.

[0021] In some examples, the shaft has a forked configuration with interior surfaces tapered to reduce spacing therebetween, and the coupling further includes a bar extending across the cavity, the interior surface of the shaft configured to engage the bar when the shaft is inserted into the cavity.

[0022] In some examples, the coupling includes opposing protrusions extending into the cavity, and the shaft defines opposing grooves to receive the protrusions therein when the shaft is fully inserted into the cavity.

[0023] In the above examples, the needle tip can define the cavity and the needle body can include the shaft. In further examples, the needle tip defines one or more recesses adjacent to the cavity such that the coupling is tolerant of debris.

[0024] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.BRIEF DESCRIPTIONS OF THE DRAWINGS

[0025] FIG. 1 is a simplified diagram of a medical system according to some embodiments.

[0026] FIG. 2A is a simplified diagram of a medical instrument system according to some embodiments.

[0027] FIG. 2B is a simplified diagram of a medical instrument including a medical tool within an elongate device according to some embodiments.

[0028] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments.

[0029] FIG. 4A is a top exploded view of a first example needle including a needle body and a needle tip according to some embodiments.

[0030] FIG. 4B is a top view of the needle tip of FIG. 4A according to some embodiments.

[0031] FIG. 4C is a rear perspective view of the needle tip of FIG. 4A according to some embodiments.

[0032] FIG. 4D is a sectional view of the needle body of FIG. 4A according to some embodiments.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0033] FIG. 4E is a cross-sectional view of the needle of FIG. 4A showing the needle body and the needle tip coupled together according to some embodiments.

[0034] FIG. 5A is a diagrammatic cross-sectional view of a second example needle including a needle body and a needle tip according to some embodiments.

[0035] FIG. 5B is a diagrammatic cross-sectional view of the needle of FIG. 5A according to some embodiments.

[0036] FIG. 6 is a sectional perspective view of a third example needle including a needle body and a needle tip according to some embodiments.

[0037] FIG. 7 A is an exploded perspective view of a fourth example needle including a needle body and a needle tip according to some embodiments.

[0038] FIG. 7B is an exploded perspective view of the needle of FIG. 7A according to some embodiments.

[0039] FIG. 8A is a sectional view of a fifth example needle including a needle body and a needle tip according to some embodiments.

[0040] FIG. 8B is a sectional top view of the needle body of FIG. 8A according to some embodiments.

[0041] FIG. 8C is a sectional rear view of the needle tip of FIG. 8A according to some embodiments.

[0042] FIG. 9A is a perspective view of a needle tip for a sixth example needle according to some embodiments.

[0043] FIG. 9B is a sectional perspective view of a needle body for the sixth example needle according to some embodiments.

[0044] FIG. 9C is a sectional perspective view of the sixth example needle including the needle tip of FIG. 9A and the needle body of FIG. 9B according to some embodiments.

[0045] FIG. 9D is a cross-sectional view of the needle of FIG. 4C according to some embodiments.

[0046] FIG. 10 is a flow chart illustrating a method according to some embodiments.

[0047] FIG. 11A depicts an isometric view of a suturing device in accordance with some embodiments of the present disclosure coupled to a distal end portion of an endoscope, or aspects thereof.

[0048] FIGS. 11B-11E depict various isometric views of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0049] FIG. 11F depicts a transparent isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0050] FIG. 11 G depicts a partial isometric view of a suturing device in accordance with some embodiments of the present disclosure, or aspects thereof.

[0051] FIG. 11H depicts a distal view of the device of FIG. 11 A, or aspects thereof.

[0052] Embodiments of the present disclosure and their advantages are best understood by referring to the detailed description that follows. It should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures, wherein showings therein are for purposes of illustrating embodiments of the present disclosure and not for purposes of limiting the same.DETAILED DESCRIPTION

[0053] In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

[0054] This disclosure describes various instruments and portions of instruments in terms of their state in three-dimensional space. As used herein, the term “position” refers to the location of an object or a portion of an object in a three-dimensional space (e.g., three degrees of translational freedom along Cartesian x-, y-, and z-coordinates). As used herein, the term “orientation” refers to the rotational placement of an object or a portion of an object (e.g., one or more degrees of rotational freedom such as, roll, pitch, and yaw). As used herein, the term “pose” refers to the position of an object or a portion of an object in at least one degree of translational freedom and to the orientation of that object or portion of the object in at least one degree of rotational freedom (e.g., up to six total degrees of freedom). As used herein, the term “shape” refers to a set of poses, positions, and / or orientations measured along an object. As used herein, the term “distal” refers to a position that is closer to a procedural site and the term “proximal” refers to a position that is further from the procedural site. Accordingly, the distal portion or distal end of an instrument isIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC closer to a procedural site than a proximal portion or proximal end of the instrument when the instrument is being used as designed to perform a procedure.

[0055] In some examples, the needle described herein includes a needle body and a needle tip that are releasably secured together via a shaft and cavity coupling that includes a detent. The detent includes a flexure member that resiliently deflects as the needle body and needle tip are coupled together and at least partially returns when the needle body and needle tip are fully coupled together to engage components of the detent. The flexure member can be a bar integral with the needle tip, an elastomer coupled to the needle tip, a protrusion(s) or ridge(s) within the cavity, and so forth. The detent includes a notch and a catch that cooperate to hold the needle tip on the needle body. The catch is coupled to or is the flexure member to be deflected a sufficient distance during coupling of the needle body and needle tip to be inserted into the notch as the flexure member resiliently returns towards its original position.

[0056] In other examples, the needle described herein includes a needle body and a needle tip that are releasably secured together via a shaft and cavity coupling that includes one or more tapered friction surfaces that result in increasing forces as the shaft is inserted into the cavity. For example, the shaft can have a forked configuration with interior tapered surfaces that engage a bar extending across the shaft, the shaft can have a ring with a rearwardly tapered surface, and so forth.

[0057] In other examples, the needle described herein includes a needle body and a needle tip that are releasably secured together via a shaft and cavity coupling that includes one or more bars that at least partially extend through an interior of the cavity, such that the shaft frictionally engages the one or more bars when inserted therein to hold the needle body and the needle tip together. In one example, the coupling includes a bar extending across the interior and the shaft has a forked configuration with interior tapered surfaces that engage the bar extending across the shaft as the shaft is inserted into the cavity, the tapered friction surfaces resulting in increasing forces as the shaft is inserted fully into the cavity. In another example, the cavity includes opposing bars that protrude into the interior cavity adjacent to a sidewall of the cavity and the shaft includes notches at a depth corresponding to the shaft being fully inserted into the cavity.

[0058] FIG. 1 is a simplified diagram of a medical system 100 according to some embodiments. The medical system 100 may be suitable for use in, for example, surgical, diagnostic (e.g., biopsy), or therapeutic (e.g., ablation, electroporation, etc.) procedures. While some embodiments are provided herein with respect to such procedures, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein may be used for animals, human cadavers, animal cadavers, portions of human or animalIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC anatomy, non-surgical diagnosis, as well as for industrial systems, general or special purpose robotic systems, general or special purpose teleoperational systems, or robotic medical systems.

[0059] As shown in FIG. 1, medical system 100 may include a manipulator assembly 102 that controls the operation of a medical instrument 104 in performing various procedures on a patient P. Medical instrument 104 may extend into an internal site within the body of patient P via an opening in the body of patient P. The manipulator assembly 102 may be teleoperated, nonteleoperated, or a hybrid teleoperated and non-teleoperated assembly with one or more degrees of freedom of motion that may be motorized and / or one or more degrees of freedom of motion that may be non-motorized (e.g., manually operated). The manipulator assembly 102 may be mounted to and / or positioned near a patient table T. A master assembly 106 allows an operator O (e.g., a surgeon, a clinician, a physician, or other user) to control the manipulator assembly 102. In some examples, the master assembly 106 allows the operator O to view the procedural site or other graphical or informational displays. In some examples, the manipulator assembly 102 may be excluded from the medical system 100 and the instrument 104 may be controlled directly by the operator O. In some examples, the manipulator assembly 102 may be manually controlled by the operator O. Direct operator control may include various handles and operator interfaces for handheld operation of the instrument 104.

[0060] The master assembly 106 may be located at a surgeon’s console which is in proximity to (e.g., in the same room as) a patient table T on which patient P is located, such as at the side of the patient table T. In some examples, the master assembly 106 is remote from the patient table T, such as in in a different room or a different building from the patient table T. The master assembly 106 may include one or more control devices for controlling the manipulator assembly 102. The control devices may include any number of a variety of input devices, such as joysticks, trackballs, scroll wheels, directional pads, buttons, data gloves, trigger-guns, hand-operated controllers, voice recognition devices, motion or presence sensors, and / or the like.

[0061] The manipulator assembly 102 supports the medical instrument 104 and may include a kinematic structure of links that provide a set-up structure. The links may include one or more non-servo controlled links (e.g., one or more links that may be manually positioned and locked in place) and / or one or more servo controlled links (e.g., one or more links that may be controlled in response to commands, such as from a control system 112). The manipulator assembly 102 may include a plurality of actuators (e.g., motors) that drive inputs on the medical instrument 104 in response to commands, such as from the control system 112. The actuators may include drive systems that move the medical instrument 104 in various ways when coupled to the medical instrument 104. For example, one or more actuators may advance medical instrument 104 into aIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC naturally or surgically created anatomic orifice. Actuators may control articulation of the medical instrument 104, such as by moving the distal end (or any other portion) of medical instrument 104 in multiple degrees of freedom. These degrees of freedom may include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). One or more actuators may control rotation of the medical instrument about a longitudinal axis. Actuators can also be used to move an articulable end effector of medical instrument 104, such as for grasping tissue in the jaws of a biopsy device and / or the like, or may be used to move or otherwise control tools (e.g., imaging tools, ablation tools, biopsy tools, electroporation tools, etc.) that are inserted within the medical instrument 104.

[0062] The medical system 100 may include a sensor system 108 with one or more sub-systems for receiving information about the manipulator assembly 102 and / or the medical instrument 104. Such sub-systems may include a position sensor system (e.g., that uses electromagnetic (EM) sensors or other types of sensors that detect position or location); a shape sensor system for determining the position, orientation, speed, velocity, pose, and / or shape of a distal end and / or of one or more segments along a flexible body of the medical instrument 104; a visualization system (e.g., using a color imaging device, an infrared imaging device, an ultrasound imaging device, an x-ray imaging device, a fluoroscopic imaging device, a computed tomography (CT) imaging device, a magnetic resonance imaging (MRI) imaging device, or some other type of imaging device) for capturing images, such as from the distal end of medical instrument 104 or from some other location; and / or actuator position sensors such as resolvers, encoders, potentiometers, and the like that describe the rotation and / or orientation of the actuators controlling the medical instrument 104.

[0063] The medical system 100 may include a display system 110 for displaying an image or representation of the procedural site and the medical instrument 104. Display system 110 and master assembly 106 may be oriented so physician O can control medical instrument 104 and master assembly 106 with the perception of telepresence.

[0064] In some embodiments, the medical instrument 104 may include a visualization system, which may include an image capture assembly that records a concurrent or real-time image of a procedural site and provides the image to the operator O through one or more displays of display system 110. The image capture assembly may include various types of imaging devices. The concurrent image may be, for example, a two-dimensional image or a three-dimensional image captured by an endoscope positioned within the anatomical procedural site. In some examples, the visualization system may include endoscopic components that may be integrally or removablyIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC coupled to medical instrument 104. Additionally or alternatively, a separate endoscope, attached to a separate manipulator assembly, may be used with medical instrument 104 to image the procedural site. The visualization system may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, such as of the control system 112.

[0065] Display system 110 may also display an image of the procedural site and medical instruments, which may be captured by the visualization system. In some examples, the medical system 100 provides a perception of telepresence to the operator O. For example, images captured by an imaging device at a distal portion of the medical instrument 104 may be presented by the display system 110 to provide the perception of being at the distal portion of the medical instrument 104 to the operator O. The input to the master assembly 106 provided by the operator O may move the distal portion of the medical instrument 104 in a manner that corresponds with the nature of the input (e.g., distal tip turns right when a trackball is rolled to the right) and results in corresponding change to the perspective of the images captured by the imaging device at the distal portion of the medical instrument 104. As such, the perception of telepresence for the operator O is maintained as the medical instrument 104 is moved using the master assembly 106. The operator O can manipulate the medical instrument 104 and hand controls of the master assembly 106 as if viewing the workspace in substantially true presence, simulating the experience of an operator that is physically manipulating the medical instrument 104 from within the patient anatomy.

[0066] In some examples, the display system 110 may present virtual images of a procedural site that are created using image data recorded pre-operatively (e.g., prior to the procedure performed by the medical instrument system 200) or intra-operatively (e.g., concurrent with the procedure performed by the medical instrument system 200), such as image data created using computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The virtual images may include two-dimensional, three-dimensional, or higher-dimensional (e.g., including, for example, time based or velocity-based information) images. In some examples, one or more models are created from pre-operative or intra-operative image data sets and the virtual images are generated using the one or more models.

[0067] In some examples, for purposes of imaged guided medical procedures, display system 110 may display a virtual image that is generated based on tracking the location of medical instrument 104. For example, the tracked location of the medical instrument 104 may be registered (e.g., dynamically referenced) with the model generated using the pre-operative or intra-operativeIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC images, with different portions of the model correspond with different locations of the patient anatomy. As the medical instrument 104 moves through the patient anatomy, the registration is used to determine portions of the model corresponding with the location and / or perspective of the medical instrument 104 and virtual images are generated using the determined portions of the model. This may be done to present the operator O with virtual images of the internal procedural site from viewpoints of medical instrument 104 that correspond with the tracked locations of the medical instrument 104.

[0068] The medical system 100 may also include the control system 112, which may include processing circuitry that implements the some or all of the methods or functionality discussed herein. The control system 112 may include at least one memory and at least one processor for controlling the operations of the manipulator assembly 102, the medical instrument 104, the master assembly 106, the sensor system 108, and / or the display system 110. Control system 112 may include instructions (e.g., a non-transitory machine-readable medium storing the instructions) that when executed by the at least one processor, configures the one or more processors to implement some or all of the methods or functionality discussed herein. While the control system 112 is shown as a single block in FIG. 1, the control system 112 may include two or more separate data processing circuits with one portion of the processing being performed at the manipulator assembly 102, another portion of the processing being performed at the master assembly 106, and / or the like. In some examples, the control system 112 may include other types of processing circuitry, such as application-specific integrated circuits (ASICs) and / or field-programmable gate array (FPGAs). The control system 112 may be implemented using hardware, firmware, software, or a combination thereof.

[0069] In some examples, the control system 112 may receive feedback from the medical instrument 104, such as force and / or torque feedback. Responsive to the feedback, the control system 112 may transmit signals to the master assembly 106. In some examples, the control system 112 may transmit signals instructing one or more actuators of the manipulator assembly 102 to move the medical instrument 104. In some examples, the control system 112 may transmit informational displays regarding the feedback to the display system 110 for presentation or perform other types of actions based on the feedback.

[0070] The control system 112 may include a virtual visualization system to provide navigation assistance to operator O when controlling the medical instrument 104 during an image-guided medical procedure. Virtual navigation using the virtual visualization system may be based upon an acquired pre-operative or intra-operative dataset of anatomic passageways of the patient P. The control system 112 or a separate computing device may convert the recorded images, usingIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC programmed instructions alone or in combination with operator inputs, into a model of the patient anatomy. The model may include a segmented two-dimensional or three-dimensional composite representation of a partial or an entire anatomic organ or anatomic region. An image data set may be associated with the composite representation. The virtual visualization system may obtain sensor data from the sensor system 108 that is used to compute an (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The sensor system 108 may be used to register and display the medical instrument 104 together with the pre-operatively or intra-operatively recorded images. For example, PCT Publication WO 2016 / 191298 (published December 1, 2016 and titled “Systems and Methods of Registration for Image Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0071] During a virtual navigation procedure, the sensor system 108 may be used to compute the (e.g., approximate) location of the medical instrument 104 with respect to the anatomy of patient P. The location can be used to produce both macro-level (e.g., external) tracking images of the anatomy of patient P and virtual internal images of the anatomy of patient P. The system may include one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to register and display a medical instrument together with pre-operatively recorded medical images. For example, U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety, discloses example systems.

[0072] Medical system 100 may further include operations and support systems (not shown) such as illumination systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the medical system 100 may include more than one manipulator assembly and / or more than one master assembly. The exact number of manipulator assemblies may depend on the medical procedure and space constraints within the procedural room, among other factors. Multiple master assemblies may be co-located or they may be positioned in separate locations. Multiple master assemblies may allow more than one operator to control one or more manipulator assemblies in various combinations.

[0073] FIG. 2A is a simplified diagram of a medical instrument system 200 according to some embodiments. The medical instrument system 200 includes a flexible elongate device 202 (also referred to as elongate device 202), a drive unit 204, and a medical tool 226 that collectively is an example of a medical instrument 104 of a medical system 100. The medical system 100 may be a teleoperated system, a non-teleoperated system, or a hybrid teleoperated and non-teleoperated system, as explained with reference to FIG. 1. A visualization system 231, tracking system 230, and navigation system 232 are also shown in FIG. 2A and are example components of the controlIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC system 112 of the medical system 100. In some examples, the medical instrument system 200 may be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. The medical instrument system 200 may be used to gather (e.g., measure) a set of data points corresponding to locations within anatomic passageways of a patient, such as patient P.

[0074] The elongate device 202 is coupled to the drive unit 204. The elongate device 202 includes a channel 221 through which the medical tool 226 may be inserted. The elongate device 202 navigates within patient anatomy to deliver the medical tool 226 to a procedural site. The elongate device 202 includes a flexible body 216 having a proximal end 217 and a distal end 218. In some examples, the flexible body 216 may have an approximately 3 mm outer diameter. Other flexible body outer diameters may be larger or smaller.

[0075] Medical instrument system 200 may include the tracking system 230 for determining the position, orientation, speed, velocity, pose, and / or shape of the flexible body 216 at the distal end 218 and / or of one or more segments 224 along flexible body 216, as will be described in further detail below. The tracking system 230 may include one or more sensors and / or imaging devices. The flexible body 216, such as the length between the distal end 218 and the proximal end 217, may include multiple segments 224. The tracking system 230 may be implemented using hardware, firmware, software, or a combination thereof. In some examples, the tracking system 230 is part of control system 112 shown in FIG. 1.

[0076] Tracking system 230 may track the distal end 218 and / or one or more of the segments 224 of the flexible body 216 using a shape sensor 222. The shape sensor 222 may include an optical fiber aligned with the flexible body 216 (e.g., provided within an interior channel of the flexibly body 216 or mounted externally along the flexible body 216). In some examples, the optical fiber may have a diameter of approximately 200 pm. In other examples, the diameter may be larger or smaller. The optical fiber of the shape sensor 222 may form a fiber optic bend sensor for determining the shape of flexible body 216. Optical fibers including Fiber Bragg Gratings (FBGs) may be used to provide strain measurements in structures in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions, which may be applicable in some embodiments, are described in U.S. Patent Application Publication No. 2006 / 0013523 (filed July 13, 2005 and titled “Fiber optic position and shape sensing device and method relating thereto”); U.S. Patent No. 7,772,541 (filed on March 12, 2008 and titled “Fiber Optic Position and / or Shape Sensing Based on Rayleigh Scatter”); and U.S. Patent No. 8,773,650 (filed on Sept. 2, 2010 and titled “Optical Position and / or Shape Sensing”), which are all incorporated by reference herein in their entireties. Sensors in some embodimentsIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and Fluorescence scattering.

[0077] In some examples, the shape of the flexible body 216 may be determined using other techniques. For example, a history of the position and / or pose of the distal end 218 of the flexible body 216 can be used to reconstruct the shape of flexible body 216 over an interval of time (e.g., as the flexible body 216 is advanced or retracted within a patient anatomy). In some examples, the tracking system 230 may alternatively and / or additionally track the distal end 218 of the flexible body 216 using a position sensor system 220. Position sensor system 220 may be a component of an EM sensor system with the position sensor system 220 including one or more position sensors. Although the position sensor system 220 is shown as being near the distal end 218 of the flexible body 216 to track the distal end 218, the number and location of the position sensors of the position sensor system 220 may vary to track different regions along the flexible body 216. In one example, the position sensors include conductive coils that may be subjected to an externally generated electromagnetic field. Each coil of position sensor system 220 may produce an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field. The position sensor system 220 may measure one or more position coordinates and / or one or more orientation angles associated with one or more portions of flexible body 216. In some examples, the position sensor system 220 may be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point. In some examples, the position sensor system 220 may be configured and positioned to measure five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point. Further description of a position sensor system, which may be applicable in some embodiments, is provided in U.S. Patent No. 6,380,732 (filed August 11, 1999 and titled “Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated by reference herein in its entirety.

[0078] In some embodiments, the tracking system 230 may alternately and / or additionally rely on a collection of pose, position, and / or orientation data stored for a point of an elongate device 202 and / or medical tool 226 captured during one or more cycles of alternating motion, such as breathing. This stored data may be used to develop shape information about the flexible body 216. In some examples, a series of position sensors (not shown), such as EM sensors like the sensors in position sensor 220 or some other type of position sensors may be positioned along the flexible body 216 and used for shape sensing. In some examples, a history of data from one or more ofIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC these position sensors taken during a procedure may be used to represent the shape of elongate device 202, particularly if an anatomic passageway is generally static.

[0079] FIG. 2B is a simplified diagram of the medical tool 226 within the elongate device 202 according to some embodiments. The flexible body 216 of the elongate device 202 may include the channel 221 sized and shaped to receive the medical tool 226. In some embodiments, the medical tool 226 may be used for procedures such as diagnostics, imaging, surgery, biopsy, ablation, illumination, irrigation, suction, electroporation, etc. Medical tool 226 can be deployed through channel 221 of flexible body 216 and operated at a procedural site within the anatomy. Medical instrument 226 may be, for example, an image capture probe, a biopsy tool (e.g., a needle, grasper, brush, etc.), an ablation tool (e.g., a laser ablation tool, radio frequency (RF) ablation tool, cryoablation tool, thermal ablation tool, heated liquid ablation tool, etc.), an electroporation tool, and / or another surgical, diagnostic, or therapeutic tool. In some examples, the medical tool 226 may include an end effector having a single working member such as a scalpel, a blunt blade, an optical fiber, an electrode, and / or the like. Other end types of end effectors may include, for example, forceps, graspers, scissors, staplers, clip appliers, and / or the like. Other end effectors may further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, and / or the like.

[0080] The medical tool 226 may be a biopsy tool used to remove sample tissue or a sampling of cells from a target anatomic location. In some examples, the biopsy tool is a flexible needle. The biopsy tool may further include a sheath that can surround the flexible needle to protect the needle and interior surface of the channel 221 when the biopsy tool is within the channel 221. The medical tool 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera that may be placed at or near the distal end 218 of flexible body 216 for capturing images (e.g., still or video images). The captured images may be processed by the visualization system 231 for display and / or provided to the tracking system 230 to support tracking of the distal end 218 of the flexible body 216 and / or one or more of the segments 224 of the flexible body 216. The image capture probe may include a cable for transmitting the captured image data that is coupled to an imaging device at the distal portion of the image capture probe. In some examples, the image capture probe may include a fiber-optic bundle, such as a fiberscope, that couples to a more proximal imaging device of the visualization system 231. The image capture probe may be single- spectral or multi-spectral, for example, capturing image data in one or more of the visible, near-infrared, infrared, and / or ultraviolet spectrums. The image capture probe may also include one or more light emitters that provide illumination to facilitate image capture. InIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC some examples, the image capture probe may use ultrasound, x-ray, fluoroscopy, CT, MRI, or other types of imaging technology.

[0081] In some examples, the image capture probe is inserted within the flexible body 216 of the elongate device 202 to facilitate visual navigation of the elongate device 202 to a procedural site and then is replaced within the flexible body 216 with another type of medical tool 226 that performs the procedure. In some examples, the image capture probe may be within the flexible body 216 of the elongate device 202 along with another type of medical tool 226 to facilitate simultaneous image capture and tissue intervention, such as within the same channel 221 or in separate channels. A medical tool 226 may be advanced from the opening of the channel 221 to perform the procedure (or some other functionality) and then retracted back into the channel 221 when the procedure is complete. The medical tool 226 may be removed from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along flexible body 216.

[0082] In some examples, the elongate device 202 may include integrated imaging capability rather than utilize a removable image capture probe. For example, the imaging device (or fiberoptic bundle) and the light emitters may be located at the distal end 218 of the elongate device 202. The flexible body 216 may include one or more dedicated channels that carry the cable(s) and / or optical fiber(s) between the distal end 218 and the visualization system 231. Here, the medical instrument system 200 can perform simultaneous imaging and tool operations.

[0083] In some examples, the medical tool 226 is capable of controllable articulation. The medical tool 226 may house cables (which may also be referred to as pull wires), linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably bend the distal end of medical tool 226, such as discussed herein for the flexible elongate device 202. The medical tool 226 may be coupled to a drive unit 204 and the manipulator assembly 102. In these examples, the elongate device 202 may be excluded from the medical instrument system 200 or may be a flexible device that does not have controllable articulation. Steerable instruments or tools, applicable in some embodiments, are further described in detail in U.S. Patent No.7,316,681 (filed on Oct. 4, 2005 and titled “Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity”) and U.S. Patent No.9,259,274 (filed Sept. 30, 2008 and titled “Passive Preload and Capstan Drive for Surgical Instruments”), which are incorporated by reference herein in their entireties.

[0084] The flexible body 216 of the elongate device 202 may also or alternatively house cables, linkages, or other steering controls (not shown) that extend between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 as shown, for example, by broken dashedIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC line depictions 219 of the distal end 218 in FIG. 2A. In some examples, at least four cables are used to provide independent up-down steering to control a pitch of the distal end 218 and left-right steering to control a yaw of the distal end 218. In these examples, the flexible elongate device 202 may be a steerable catheter. Examples of steerable catheters, applicable in some embodiments, are described in detail in PCT Publication WO 2019 / 018736 (published Jan. 24, 2019 and titled “Flexible Elongate Device Systems and Methods”), which is incorporated by reference herein in its entirety.

[0085] In embodiments where the elongate device 202 and / or medical tool 226 are actuated by a teleoperational assembly (e.g., the manipulator assembly 102), the drive unit 204 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some examples, the elongate device 202 and / or medical tool 226 may include gripping features, manual actuators, or other components for manually controlling the motion of the elongate device 202 and / or medical tool 226. The elongate device 202 may be steerable or, alternatively, the elongate device 202 may be non-steerable with no integrated mechanism for operator control of the bending of distal end 218. In some examples, one or more channels 221 (which may also be referred to as lumens), through which medical tools 226 can be deployed and used at a target anatomical location, may be defined by the interior walls of the flexible body 216 of the elongate device 202.

[0086] In some examples, the medical instrument system 200 (e.g., the elongate device 202 or medical tool 226) may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter, for use in examination, diagnosis, biopsy, and / or treatment of a lung. The medical instrument system 200 may also be suited for navigation and treatment of other tissues, via natural or surgically created connected passageways, in any of a variety of anatomic systems, including the colon, the intestines, the kidneys and kidney calices, the brain, the heart, the circulatory system including vasculature, and / or the like.

[0087] The information from the tracking system 230 may be sent to the navigation system 232, where the information may be combined with information from the visualization system 231 and / or pre-operatively obtained models to provide the physician, clinician, surgeon, or other operator with real-time position information. In some examples, the real-time position information may be displayed on the display system 110 for use in the control of the medical instrument system 200. In some examples, the navigation system 232 may utilize the position information as feedback for positioning medical instrument system 200. Various systems for using fiber optic sensors to register and display a surgical instrument with surgical images, applicable in some embodiments, are provided in U.S. Patent No. 8,900,131 (filed May 13, 2011 and titled “Medical SystemIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery”), which is incorporated by reference herein in its entirety.

[0088] FIGS. 3 A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insertion assembly according to some embodiments. As shown in FIGS. 3 A and 3B, a surgical environment 300 may include a patient P positioned on the patient table T. Patient P may be stationary within the surgical environment 300 in the sense that gross patient movement is limited by sedation, restraint, and / or other means. Cyclic anatomic motion, including respiration and cardiac motion, of patient P may continue. Within surgical environment 300, a medical instrument 304 is used to perform a medical procedure which may include, for example, surgery, biopsy, ablation, illumination, irrigation, suction, or electroporation. The medical instrument 304 may also be used to perform other types of procedures, such as a registration procedure to associate the position, orientation, and / or pose data captured by the sensor system 108 to a desired (e.g., anatomical or system) reference frame. The medical instrument 304 may be, for example, the medical instrument 104. In some examples, the medical instrument 304 may include an elongate device 310 (e.g., a catheter) coupled to an instrument body 312. Elongate device 310 includes one or more channels sized and shaped to receive a medical tool.

[0089] Elongate device 310 may also include one or more sensors (e.g., components of the sensor system 108). In some examples, a shape sensor 314 may be fixed at a proximal point 316 on the instrument body 312. The proximal point 316 of the shape sensor 314 may be movable with the instrument body 312, and the location of the proximal point 316 with respect to a desired reference frame may be known (e.g., via a tracking sensor or other tracking device). The shape sensor 314 may measure a shape from the proximal point 316 to another point, such as a distal end 318 of the elongate device 310. The shape sensor 314 may be aligned with the elongate device 310 (e.g., provided within an interior channel or mounted externally). In some examples, the shape sensor 314 may optical fibers used to generate shape information for the elongate device 310.

[0090] In some examples, position sensors (e.g., EM sensors) may be incorporated into the medical instrument 304. A series of position sensors may be positioned along the flexible elongate device 310 and used for shape sensing. Position sensors may be used alternatively to the shape sensor 314 or with the shape sensor 314, such as to improve the accuracy of shape sensing or to verify shape information.

[0091] Elongate device 310 may house cables, linkages, or other steering controls that extend between the instrument body 312 and the distal end 318 to controllably bend the distal end 318. In some examples, at least four cables are used to provide independent up-down steering to control aIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC pitch of distal end 318 and left-right steering to control a yaw of distal end 318. The instrument body 312 may include drive inputs that removably couple to and receive power from drive elements, such as actuators, of a manipulator assembly.

[0092] The instrument body 312 may be coupled to an instrument carriage 306. The instrument carriage 306 may be mounted to an insertion stage 308 that is fixed within the surgical environment 300. Alternatively, the insertion stage 308 may be movable but have a known location (e.g., via a tracking sensor or other tracking device) within surgical environment 300. Instrument carriage 306 may be a component of a manipulator assembly (e.g., manipulator assembly 102) that couples to the medical instrument 304 to control insertion motion (e.g., motion along an insertion axis A) and / or motion of the distal end 318 of the elongate device 310 in multiple directions, such as yaw, pitch, and / or roll. The instrument carriage 306 or insertion stage 308 may include actuators, such as servomotors, that control motion of instrument carriage 306 along the insertion stage 308.

[0093] A sensor device 320, which may be a component of the sensor system 108, may provide information about the position of the instrument body 312 as it moves relative to the insertion stage 308 along the insertion axis A. The sensor device 320 may include one or more resolvers, encoders, potentiometers, and / or other sensors that measure the rotation and / or orientation of the actuators controlling the motion of the instrument carriage 306, thus indicating the motion of the instrument body 312. In some embodiments, the insertion stage 308 has a linear track as shown in FIGS. 3 A and 3B. In some embodiments, the insertion stage 308 may have curved track or have a combination of curved and linear track sections.

[0094] FIG. 3 A shows the instrument body 312 and the instrument carriage 306 in a retracted position along the insertion stage 308. In this retracted position, the proximal point 316 is at a position L0 on the insertion axis A. The location of the proximal point 316 may be set to a zero value and / or other reference value to provide a base reference (e.g., corresponding to the origin of a desired reference frame) to describe the position of the instrument carriage 306 along the insertion stage 308. In the retracted position, the distal end 318 of the elongate device 310 may be positioned just inside an entry orifice of patient P. Also in the retracted position, the data captured by the sensor device 320 may be set to a zero value and / or other reference value (e.g., 1=0). In FIG.3B, the instrument body 312 and the instrument carriage 306 have advanced along the linear track of insertion stage 308, and the distal end 318 of the elongate device 310 has advanced into patient P. In this advanced position, the proximal point 316 is at a position LI on the insertion axis A. In some examples, the rotation and / or orientation of the actuators measured by the sensor device 320 indicating movement of the instrument carriage 306 along the insertion stage 308 and / or one or more position sensors associated with instrument carriage 306 and / or the insertion stage 308 mayIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC be used to determine the position LI of the proximal point 316 relative to the position L0. In some examples, the position LI may further be used as an indicator of the distance or insertion depth to which the distal end 318 of the elongate device 310 is inserted into the passageway(s) of the anatomy of patient P.

[0095] Example needles for medical devices are shown in FIGS. 4A-8C. The needles have an arcuate configuration, such that the needles can be driven by a rotary needle driver. In some examples, the needles are utilized for suturing and, as such, include thread connections (e.g., suture openings). Further, the needles include a needle body and a needle tip that can be releasably coupled together. With this configuration, the needle tip can be disconnected from the needle body after a suture is completed and left in situ to provide a suture anchor.

[0096] A first example needle 400 is shown in FIGS. 4A-4E. The needle 400 includes a needle tip 402 and a needle body 404 that are configured to releasably secure together. As shown, the needle body 404 has an arcuate configuration (e.g., forming a portion of a ring) to be driven by a rotary needle driver for suturing procedures. In some examples, the needle tip 402 can have an arcuate configuration generally following the arc of the needle body 404. In other examples, the needle tip 402 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0097] The needle 400 includes a coupling 406 to releasably couple the needle tip 402 and needle body 404 together. The coupling 406 includes a shaft 408 and a cavity 410 sized to receive the shaft 408. In one example, the needle tip 402 defines the cavity 410 and the needle body 404 includes the shaft 408 at a distal end thereof. In another example, the needle body 404 defines the cavity 410 and the needle tip 402 includes the shaft 408 at a proximal end thereof.

[0098] The coupling 406 further includes a detent 412 that is configured to releasably hold the shaft 408 and the cavity 410 together. The detent 412 includes a notch 414, a catch 416, and a flexure member 418 that is configured to resiliently deform and subsequently insert the catch 416 into the notch 414 when the needle body 404 and the needle tip 402 are fully coupled together. With this configuration, as the shaft 408 is inserted into the cavity 410, the flexure member 418 is deformed, such that the flexure member 418 can then resiliently return towards its original position which inserts the catch 416 into the notch 414 to secure the needle tip 402 to the needle body 404.

[0099] As shown, an interior surface 420 of the cavity 410 and the shaft 408 can include engagement features to restrict or prevent relative rotation between the needle tip 402 and the needle body 404. In one example, the interior surface 420 of the cavity 410 includes at least one planar portion 422 and the shaft 408 includes a corresponding planar portion 424 that extend along one another when the shaft 408 is inserted into the cavity 410. The planar portions 422, 424 engageIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC one another to restrict or prevent relative rotation between the needle tip 402 and the needle body 404. In some examples, the cavity 410 and shaft 408 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered corners, as well as portion of the cavity 410 and / or shaft 408 having other cross-sections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0100] As shown in FIG. 4D, the shaft 408 includes a ramp 426 to deform the flexure member 418 while the shaft 408 is being inserted into the cavity 410. For example, the flexure member 418 is driven up the ramp 426 which deforms the flexure member 418 from its original position. In some examples, the catch 416 depends inwardly from a distal end of the flexure member 418, such that the catch 416 contacts and slides up the ramp 426 during insertion of the shaft 408 into the cavity 410. As the catch 416 is driven past the end of the ramp 426, the flexure member 418 resiliently returns to shape, driving the catch 416 inwardly and inserting the catch 416 into the notch 414, which is disposed adjacent to the ramp 426.

[0101] In some examples, the notch 414 includes a retention surface 428 extends from an end of the ramp 426. The angle of the retention surface 428 of the notch 414 can be steeper than an angle of the ramp 426, such that the flexure member 418 deforms gradually, while the catch 416 engages the relatively steeper retention surface 428. The catch 416 includes an engagement surface 430 configured to engage the retention surface 428 of the notch 414. In one example, both the retention surface 428 and the engagement surface 430 can be planar extending along approximately the same angle. In other examples, the engagement surface 430 and the retention surface 428 can be at least partially misaligned to limit the coupling area therebetween. For example, the engagement surface 430 can be curved, as shown in FIG. 4E, and the retention surface 428 can be planar. Alternatively, both the retention surface 428 and the engagement surface 430 can be planar extending along different angles or the both the retention surface 428 and the engagement surface 430 can have different curvatures.

[0102] An example of the coupling 406 for the shaft 408 and the cavity 410 is shown in FIG.4E. In this example, the needle tip 402 defines the cavity 410 with a sidewall 432 of the needle tip 402 extending around the cavity 410. The flexure member 418 is defined in the sidewall 432, with by one or more slot openings 434 extending therethrough. Further, the catch 416 depends inwardly from a distal end of the flexure member 418 to extend into the cavity 410. With this configuration, the flexure member 418 has a cantilevered form that flexes along its length.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0103] As discussed, the needle 400 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 402 can define one or more suture openings 436 therethrough so that a thread can be secured to the needle tip 402 before a procedure. Thereafter, the needle tip 402 can be uncoupled from the needle body 404 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.

[0104] The shaft 408 of this example needle 400 is shown in FIG. 4D. The shaft 408 defines the notch 414 adjacent to a proximal end thereof, such that the shaft 408 can be fully inserted into the cavity 410 defined by the needle tip 402. As shown, the shaft 408 includes the ramp 426 extending along a longitudinal length thereof, with a top of the ramp 426 disposed adjacent to the proximal end of the shaft 408.

[0105] An outer diameter of the needle body 404 proximal to the shaft 408 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 404 has a shoulder 438 extending radially outward from the shaft 408. In some examples, the shoulder 438 can extend around an entire perimeter of the shaft 408. In other examples, the shoulder 438 is disposed adjacent to one or more sides of the shaft 408 with a recess 440 providing a catch for operation of a needle driver. Advantageously, the cavity 410 and the shaft 408 can be sized and configured so that the shoulder 438 abuts the needle tip 402 when the shaft 408 is fully inserted into the cavity 410. The shoulder 438 can advantageously provide a bearing surface to help maintain relative positioning of the needle tip 402 and needle body 404 when coupled and being used during a procedure. As shown, the notch 414 can be partially defined by an end wall of the ramp 426 on one side and the shoulder 438 on an opposite side. The catch 416 is received within this space when the needle tip 402 is fully coupled to the needle body 404.

[0106] A second example needle 500 is shown in FIGS. 5A-5B. The needle 500 includes a needle tip 502 and a needle body 504 that are configured to releasably secure together. As shown, the needle body 504 has an arcuate configuration (e.g., forming a portion of a ring) to be driven by a rotary needle driver for suturing procedures. In some examples, the needle tip 502 can have an arcuate configuration generally following the arc of the needle body 504. In other examples, the needle tip 502 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0107] The needle 500 includes a coupling 506 to releasably couple the needle tip 502 and needle body 504 together. The coupling 506 includes a shaft 508 and a cavity 510 sized to receive the shaft 508. In one example, the needle tip 502 defines the cavity 510 and the needle body 504Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC includes the shaft 508 at a distal end thereof. In another example, the needle body 504 defines the cavity 510 and the needle tip 502 includes the shaft 508 at a proximal end thereof.

[0108] The coupling 506 further includes a detent 512 that is configured to releasably hold the shaft 508 and the cavity 510 together. The detent 512 includes a notch 514, a catch 516, and a flexure member 518 that is configured to resiliently deform and subsequently insert the catch 516 into the notch 514 when the needle body 504 and the needle tip 502 are fully coupled together. With this configuration, as the shaft 508 is inserted into the cavity 510, the flexure member 518 is deformed, such that the flexure member 518 can then resiliently return towards its original position which inserts the catch 516 into the notch 514 to secure the needle tip 502 to the needle body 504.

[0109] As shown, an interior surface 520 of the cavity 510 and the shaft 508 can include engagement features to restrict or prevent relative rotation between the needle tip 502 and the needle body 504. In one example, the interior surface 520 of the cavity 510 includes at least one planar portion 522 and the shaft 508 includes a corresponding planar portion 524 that extend along one another when the shaft 508 is inserted into the cavity 510. The planar portions 522, 524 engage one another to restrict or prevent relative rotation between the needle tip 502 and the needle body 504. In some examples, the cavity 510 and shaft 508 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered corners, as well as portion of the cavity 510 and / or shaft 508 having other cross-sections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0110] As shown in FIG. 5A, the shaft 508 includes a ramp 526 to deform the flexure member 518 while the shaft 508 is being inserted into the cavity 510. In this example, the flexure member 518 is an elastomer that is compressed as the catch 516 is driven up the ramp 526 and resiliently returns towards an uncompressed configuration to insert the catch 516 into the notch 514.

[0111] The shaft 508 includes a base portion 527, the flexure member 518 coupled to the base portion 527, and an engagement portion 529 coupled to the flexure member 518, such that the flexure member 518 is disposed between the base portion 527 and the engagement portion 529. The engagement portion 529 includes the ramp 526 and defines the notch 514 proximally of the ramp 526. The catch 516 depends inwardly from a sidewall 532 defining the cavity 510 to engage the ramp 526, such that the catch 516 contacts and slides up the ramp 526 during insertion of the shaft 508 into the cavity 510. As the catch 516 is driven past the end of the ramp 526, the flexure member 518 resiliently returns to shape, driving the notch 514 outwardly and inserting the catch 516 into the notch 514, which is disposed adjacent to the ramp 526. The catch 516 can have anyIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC suitable configuration. For example, the catch 516 can be a protrusion from the cavity sidewall 532 with a planar or curved engagement surface, a bar or ball coupled to the cavity sidewall 532, and so forth.

[0112] An example of the coupling 506 for the shaft 508 and the cavity 510 is shown in FIGS.5 A and 5B. In this example, the needle tip 502 defines the cavity 510, while the needle body 504 includes the shaft 508 with the base portion 527, the flexure member 518, and the engagement portion 529.

[0113] In some examples, the notch 514 includes a retention surface 528 that extends from an end of the ramp 526. The angle of the retention surface 528 of the notch 514 can be steeper than an angle of the ramp 526, such that the flexure member 518 deforms gradually, while the catch 516 engages the relatively steeper retention surface 528. The catch 516 includes an engagement surface 530 configured to engage the retention surface 528 of the notch 514. In one example, both the retention surface 528 and the engagement surface 530 can be planar extending along approximately the same angle. Alternatively, in other examples, the engagement surface 530 can be curved and the retention surface 528 can be planar, the engagement surface 530 can be planar and the retention surface can be curved, the engagement surface 530 and the retention surface 528 can both be planar extending along different angles, or the engagement surface 530 and the retention surface can have different curvatures, which limits the coupling area between the retention surface 528 and the engagement surface 530.

[0114] As discussed, the needle 500 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 502 can define one or more suture openings 536 therethrough so that a thread can be secured to the needle tip 502 before a procedure. Thereafter, the needle tip 502 can be uncoupled from the needle body 504 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.

[0115] An outer diameter of the needle body 504 proximal to the shaft 508 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 504 has a shoulder 538 extending radially outward from the shaft 508. In some examples, the shoulder 538 can extend around an entire perimeter of the shaft 508. In other examples, the shoulder 538 is disposed adjacent to one or more sides of the shaft 508 with a recess 540 providing a catch for operation of a needle driver. Advantageously, the cavity 510 and the shaft 508 can be sized and configured so that the shoulder 538 abuts the needle tip 502 when the shaft 508 is fully inserted into the cavity 510. The shoulder 538 can advantageously provide a bearing surface to helpIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC maintain relative positioning of the needle tip 502 and needle body 504 when coupled and being used during a procedure.

[0116] A third example needle 600 is shown in FIG. 6. The needle 600 includes a needle tip 602 and a needle body 604 that are configured to releasably secure together. As shown, the needle body 604 has an arcuate configuration (e.g., forming a portion of a ring) to be driven by a rotary needle driver for suturing procedures. In some examples, the needle tip 602 can have an arcuate configuration generally following the arc of the needle body 604. In other examples, the needle tip 602 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0117] The needle 600 includes a coupling 606 to releasably couple the needle tip 602 and needle body 604 together. The coupling 606 includes a shaft 608 and a cavity 610 sized to receive the shaft 608. In one example, the needle tip 602 defines the cavity 610 and the needle body 604 includes the shaft 608 at a distal end thereof. In another example, the needle body 604 defines the cavity 610 and the needle tip 602 includes the shaft 608 at a proximal end thereof.

[0118] In one example, the coupling 606 includes one or more tapered surfaces 611 that are configured to result in increasing forces as the shaft 608 is inserted into the cavity 610 to releasably hold the shaft 608 and the cavity 610 together. The one or more tapered surfaces 611 contact one or more engagement surfaces 613 defining the cavity 610 or extending into the cavity 610. With this configuration, as the shaft 608 is inserted into the cavity 610, the tapered surfaces 611 contact the engagement surfaces 613 and, due the angle of the tapered surfaces 611, impart increasing pressure on the engagement surfaces 613 to ultimately secure the needle tip 602 to the needle body 604.

[0119] In a further example, the coupling 606 includes a detent 612 that is configured to releasably hold the shaft 608 and the cavity 610 together. The detent 612 includes one or more bars 616 that extend at least partially into an interior of the cavity 610 and one or more contoured surfaces 618 that are configured to engage the one or more bars 616 as the shaft 608 is inserted into the cavity 610 to secure the needle tip 602 to the needle body 604.

[0120] As shown in the example of FIG. 6, the shaft 608 has a forked configuration with the tapered surfaces 611 provided on an interior of the forked configuration to reduce spacing therebetween. With this example, the bar 616 extends across the cavity 610, such that the tapered surfaces 611 of the interior of the shaft 608 engage the bar 616 when the shaft 608 is inserted into the cavity 610. The bar 616 can be secured a sidewall 632 of the cavity 610 by any suitable method, such as welding or the like, or can be integral therewith.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0121] As shown, an interior surface 620 of the cavity 610 and the shaft 608 can include engagement features to restrict or prevent relative rotation between the needle tip 602 and the needle body 604. In one example, the interior surface 620 of the cavity 610 includes at least one planar portion 622 and the shaft 608 includes a corresponding planar portion 624 that extend along one another when the shaft 608 is inserted into the cavity 610. The planar portions 622, 624 engage one another to restrict or prevent relative rotation between the needle tip 602 and the needle body 604. In some examples, the cavity 610 and shaft 608 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered corners, as well as portion of the cavity 610 and / or shaft 608 having other cross-sections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0122] As discussed, the needle 600 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 602 can define one or more suture openings 636 therethrough so that a thread can be secured to the needle tip 602 before a procedure. Thereafter, the needle tip 602 can be uncoupled from the needle body 604 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.

[0123] An outer diameter of the needle body 604 proximal to the shaft 608 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 604 has a shoulder 638 extending radially outward from the shaft 608. In some examples, the shoulder 638 can extend around an entire perimeter of the shaft 608. In other examples, the shoulder 638 is disposed adjacent to one or more sides of the shaft 608 with a recess 640 providing a catch for operation of a needle driver. Advantageously, the cavity 610 and the shaft 608 can be sized and configured so that the shoulder 638 abuts the needle tip 602 when the shaft 608 is fully inserted into the cavity 610. The shoulder 638 can advantageously provide a bearing surface to help maintain relative positioning of the needle tip 602 and needle body 604 when coupled and being used during a procedure.

[0124] In some examples, the sidewall 632 defining the cavity 610 further defines one or more recesses 642 adjacent and open to the cavity 610 such that the coupling 606 is tolerant of debris within the cavity 610 when the shaft 608 is inserted into the cavity 610.

[0125] A fourth example needle 700 is shown in FIGS. 7A-7B. The needle 700 includes a needle tip 702 and a needle body 704 that are configured to releasably secure together. As shown, the needle body 704 has an arcuate configuration (e.g., forming a portion of a ring) to be drivenIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC by a rotary needle driver for suturing procedures. In some examples, the needle tip 702 can have an arcuate configuration generally following the arc of the needle body 704. In other examples, the needle tip 702 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0126] The needle 700 includes a coupling 706 to releasably couple the needle tip 702 and needle body 704 together. The coupling 706 includes a shaft 708 and a cavity 710 sized to receive the shaft 708. In one example, the needle tip 702 defines the cavity 710 and the needle body 704 includes the shaft 708 at a distal end thereof. In another example, the needle body 704 defines the cavity 710 and the needle tip 702 includes the shaft 708 at a proximal end thereof.

[0127] The coupling 706 includes one or more tapered surfaces 711 that are configured to result in increasing forces as the shaft 708 is inserted into the cavity 710 to releasably hold the shaft 708 and the cavity 710 together. The one or more tapered surfaces 711 contact one or more engagement surfaces 713 defining the cavity 710 or extending into the cavity 710. With this configuration, as the shaft 708 is inserted into the cavity 710, the tapered surfaces 711 contact the engagement surfaces 713 and, due the angle of the tapered surfaces 711, impart increasing pressure on the engagement surfaces 713 to ultimately secure the needle tip 702 to the needle body 704.

[0128] As shown in the example of FIG. 7A, the shaft 708 includes an annular protrusion 709 having the tapered surface 711 extending therearound. The annular protrusion 709 can be a discrete protrusion relative to both proximal and distal sides thereof or can be a protrusion relative to only a distal side thereof. An interior surface 720 of the cavity 710 is sized to engage the tapered surface 711 as the shaft 708 is inserted into the cavity 710. For example, a sidewall 732 of the cavity 710 includes the engagement surfaces 713 have one or more reduced dimensions (e.g., height, width, diameter, etc.) relative to adjacent portions of the cavity 710 at a depth corresponding to the shaft 708 being fully inserted into the cavity 710. With this configuration, the tapered surface 711 abuts and is driven along the engagement surfaces 713 to secure the needle tip 702 to the needle body 704 with an interference / friction fit. In one example, the tapered surface 711 is at a proximal end of the shaft 708. In other examples, the tapered surface 711 can be at an intermediate portion or distal end of the shaft 708.

[0129] As shown, the interior surface 720 of the cavity 710 and the shaft 708 can include engagement features to restrict or prevent relative rotation between the needle tip 702 and the needle body 704. In one example, the interior surface 720 of the cavity 710 can include at least one planar portion 722 and the shaft 708 can include a corresponding planar portion 724 that extend along one another when the shaft 708 is inserted into the cavity 710. The planar portions 722, 724 engage one another to restrict or prevent relative rotation between the needle tip 702 and the needleIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC body 704. In some examples, the cavity 710 and shaft 708 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered comers, as well as portion of the cavity 710 and / or shaft 708 having other crosssections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0130] As discussed, the needle 700 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 702 can define one or more suture openings 736 therethrough so that a thread can be secured to the needle tip 702 before a procedure. Thereafter, the needle tip 702 can be uncoupled from the needle body 704 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.

[0131] An outer diameter of the needle body 704 proximal to the shaft 708 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 704 has a shoulder 738 extending radially outward from the shaft 708. In some examples, the shoulder 738 can extend around an entire perimeter of the shaft 708. In other examples, the shoulder 738 is disposed adjacent to one or more sides of the shaft 708 with a recess 740 providing a catch for operation of a needle driver. Advantageously, the cavity 710 and the shaft 708 can be sized and configured so that the shoulder 738 abuts the needle tip 702 when the shaft 708 is fully inserted into the cavity 710. The shoulder 738 can advantageously provide a bearing surface to help maintain relative positioning of the needle tip 702 and needle body 704 when coupled and being used during a procedure.

[0132] In some examples, the sidewall 732 defining the cavity 710 further defines one or more recesses 742 adjacent and open to the cavity 710 such that the coupling 706 is tolerant of debris within the cavity 710 when the shaft 708 is inserted into the cavity 710.

[0133] A fifth example needle 800 is shown in FIGS. 8A-8C. The needle 800 includes a needle tip 802 and a needle body 804 that are configured to releasably secure together. As shown, the needle body 804 has an arcuate configuration (e.g., forming a portion of a ring) to be driven by a rotary needle driver for suturing procedures. In some examples, the needle tip 802 can have an arcuate configuration generally following the arc of the needle body 804. In other examples, the needle tip 802 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0134] The needle 800 includes a coupling 806 to releasably couple the needle tip 802 and needle body 804 together. The coupling 806 includes a shaft 808 and a cavity 810 sized to receiveIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC the shaft 808. In one example, the needle tip 802 defines the cavity 810 and the needle body 804 includes the shaft 808 at a distal end thereof. In another example, the needle body 804 defines the cavity 810 and the needle tip 802 includes the shaft 808 at a proximal end thereof.

[0135] The coupling 806 includes a detent 812 that is configured to releasably hold the shaft 808 and the cavity 810 together. The detent 812 includes one or more bars 816 that extend at least partially into an interior of the cavity 810 and one or more contoured surfaces 818 that are configured to engage the one or more bars 816 as the shaft 808 is inserted into the cavity 810 to secure the needle tip 802 to the needle body 804.

[0136] The detent 812 includes two bars 816 that form opposing protrusions that extend into the cavity 810 and the contoured surfaces 818 of the shaft 808 are retention grooves defined in opposing sides of the shaft 808. The grooves of the contoured surfaces 818 are sized to receive the protruding portion of the bars 816 therein when the shaft 608 is fully inserted into the cavity 810. The bars 816 can be secured a sidewall 832 of the cavity 810 by any suitable method, such as welding or the like, or can be integral therewith. In one example, as shown in FIG. 8A, the sidewall 832 can include through openings 833 to position the bars 816 within the interior of the cavity 810.

[0137] As shown, an interior surface 820 of the cavity 810 and the shaft 808 can include engagement features to restrict or prevent relative rotation between the needle tip 802 and the needle body 804. In one example, the interior surface 820 of the cavity 810 includes at least one planar portion 822 and the shaft 808 includes a corresponding planar portion 824 that extend along one another when the shaft 808 is inserted into the cavity 810. The planar portions 822, 824 engage one another to restrict or prevent relative rotation between the needle tip 802 and the needle body 804. In some examples, the cavity 810 and shaft 808 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered corners, as well as portion of the cavity 810 and / or shaft 808 having other cross-sections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0138] As discussed, the needle 800 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 802 can define one or more suture openings 836 therethrough so that a thread can be secured to the needle tip 802 before a procedure. Thereafter, the needle tip 802 can be uncoupled from the needle body 804 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0139] An outer diameter of the needle body 804 proximal to the shaft 808 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 804 has a shoulder 838 extending radially outward from the shaft 808. In some examples, the shoulder 838 can extend around an entire perimeter of the shaft 808. In other examples, the shoulder 838 is disposed adjacent to one or more sides of the shaft 808 with a recess 840 providing a catch for operation of a needle driver. Advantageously, the cavity 810 and the shaft 808 can be sized and configured so that the shoulder 838 abuts the needle tip 802 when the shaft 808 is fully inserted into the cavity 810. The shoulder 838 can advantageously provide a bearing surface to help maintain relative positioning of the needle tip 802 and needle body 804 when coupled and being used during a procedure.

[0140] In some examples, the sidewall 832 defining the cavity 810 further defines one or more recesses 842 adjacent and open to the cavity 810 such that the coupling 806 is tolerant of debris within the cavity 810 when the shaft 808 is inserted into the cavity 810.

[0141] A sixth example needle 900 is shown in FIGS. 9A-9D. The needle 900 includes a needle tip 902 and a needle body 904 that are configured to releasably secure together. As shown, the needle body 904 has an arcuate configuration (e.g., forming a portion of a ring) to be driven by a rotary needle driver for suturing procedures. In some examples, the needle tip 902 can have an arcuate configuration generally following the arc of the needle body 904. In other examples, the needle tip 902 can include a generally straight distal end or a distal end made of angled segments following a curved path.

[0142] The needle 900 includes a coupling 906 to releasably couple the needle tip 902 and needle body 904 together. The coupling 906 includes a shaft 908 and a cavity 910 sized to receive the shaft 908. In one example, the needle tip 902 defines the cavity 910 and the needle body 904 includes the shaft 908 at a distal end thereof. In another example, the needle body 904 defines the cavity 910 and the needle tip 902 includes the shaft 908 at a proximal end thereof.

[0143] The coupling 906 further includes a detent 912 that is configured to releasably hold the shaft 908 and the cavity 910 together. The detent 912 includes a slot opening or notch 914, a catch 916, and a flexure member 918 that is configured to resiliently deform and subsequently insert the catch 916 into the notch 914 when the needle body 904 and the needle tip 902 are fully coupled together. With this configuration, as the shaft 908 is inserted into the cavity 910, the flexure member 918 is deformed, such that the flexure member 918 can then resiliently return towards its original position which inserts the catch 916 into the notch 914 to secure the needle tip 902 to the needle body 904. The flexure member 918 can be formed or cut from a main portion 926 of theIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC shaft 908 or can be secured to the main portion 926 of the shaft 908 by any suitable method, such as welding.

[0144] As shown, an interior surface 920 of the cavity 910 and the shaft 908 can include engagement features to restrict or prevent relative rotation between the needle tip 902 and the needle body 904. In one example, the interior surface 920 of the cavity 910 includes at least one planar portion 922 and the shaft 908 includes a corresponding planar portion 924 that extend along one another when the shaft 908 is inserted into the cavity 910. The planar portions 922, 924 engage one another to restrict or prevent relative rotation between the needle tip 902 and the needle body 904. In some examples, the cavity 910 and shaft 908 can have a generally rectangular (e.g., square) cross-section, three flat engagement surfaces, opposing or adjacent flat engagement surfaces, and so forth. It will be understood that the above cross-sections can include rounded or chamfered corners, as well as portion of the cavity 910 and / or shaft 908 having other cross-sections, cut-outs, and / or openings / cavities. In other examples, the engagement features could include alignment feature, such as tongue-and-groove, interlocking components, and so forth.

[0145] As shown in FIG. 4D, the flexure member 918 extends rearwardly along the shaft 908 and is angled away from the main portion 926 of the shaft 908. The flexure member 918 can extend along a consistent angle, a plurality of angles, such as two as shown, and / or can have a curvature along one or more portions or the entirety thereof. In the illustrated example, a distal end 919 of the flexure member 918 is angled relatively more steeply away from the main portion 926 of the shaft 908.

[0146] With the above configuration, as the shaft 908 is being inserted into the cavity 910, the flexure member 918 engages the interior surface 920 of the cavity 910, which flexes the flexure member 918 toward the main portion 926 of the shaft 908. The flexure member 918 slides along the interior surface 920 of the cavity 910 until the distal end 919 of the flexure member 918 is driven to the notch 914 to provide the catch 916 of the coupling 906. The notch 914 allows the flexure member 918 to resiliently return towards its original shape, which positions the distal end 919 at least partially within the notch 914. The notch 914 can be defined in the interior surface 920 of the cavity 910 or, as shown in FIG. 9 A, can extend entirely through the wall defining the cavity 910. In the illustrated example, the flexure member 918 slide along an upper interior surface of the cavity 910. In other examples, the flexure member 918 can slide along one of the side surfaces or the bottom surface of the cavity 910.

[0147] The engagement between the catch 916 and the notch 914 secures the needle tip 902 and needle body 904 together. As shown in FIG. 9D, the notch 914 includes a retention surfaceIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC 928 on a proximal end thereof. The distal end 919 of the flexure member 918 abuts against the retention surface 928 to resist removal of the shaft 908 from the cavity 910.

[0148] In some examples, the flexure member 918 can include a protrusion / lip 929 sized to fit within the notch 914 for a more secure attachment. In some examples, the flexure member 918 can have a thickened portion 931 configured to engage the main portion 926 of the shaft 908 to control flexure of the flexure member 918 and more resiliently deflect the distal end 919 into the notch 914.

[0149] The flexure member 918 and, in some examples, the shaft 908, where the shaft 908 and the flexure member 918 are one material, can be made from any suitable material that is sufficiently durable to withstand multiple uses (e.g., deformations) during a procedure. Furthermore, instead of providing a thickened portion 931, the material of the flexure member 918 can be selected to be sufficiently resilient and tuned for removal of the shaft 908 from the cavity 910. For example, the thickness and the material of the flexure member 918 can both be utilized to adjust the insertion / removal forces, while also meeting durability requirements for a procedure. In some examples, 17-7 stainless steel provides strength and durability relative to a 300 series stainless steel, such as 304 stainless steel, which provides a less hard and less brittle material with an easier fabrication. Additionally, 304 stainless steel can be work-hardened to change the material properties to a desired level depending on the strength, durability, and manufacturability requirements for a particular use.

[0150] An example of the coupling 906 for the shaft 908 and the cavity 910 is shown in FIG.4D. In this example, the needle tip 902 defines the cavity 910 with a sidewall 932 of the needle tip 902 extending around the cavity 910. The notch 914 is defined in the sidewall 932 and the flexure member 918 is provided along a distal end of the needle body 904.

[0151] As discussed, the needle 900 can be suitable for creating a suture, such as with a rotary needle driver. Pursuant to this, the needle tip 902 can define one or more suture openings 936 therethrough so that a thread can be secured to the needle tip 902 before a procedure. Thereafter, the needle tip 902 can be uncoupled from the needle body 904 and left in situ to act as a suture anchor. The thread can be any suitable material for a suture, including synthetic or natural materials, including solid elastomers.

[0152] An outer diameter of the needle body 904 proximal to the shaft 908 can have one or more larger cross-sectional dimensions (e.g., diameter), such that the needle body 904 has a shoulder 938 extending radially outward from the shaft 908. In some examples, the shoulder 938 can extend around an entire perimeter of the shaft 908. In other examples, the shoulder 938 is disposed adjacent to one or more sides of the shaft 908 with a recess 940 providing a catch forIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC operation of a needle driver. Advantageously, the cavity 910 and the shaft 908 can be sized and configured so that the shoulder 938 abuts the needle tip 902 when the shaft 908 is fully inserted into the cavity 910. The shoulder 938 can advantageously provide a bearing surface to help maintain relative positioning of the needle tip 902 and needle body 904 when coupled and being used during a procedure.

[0153] In some examples, the needle 400, 500, 600, 700, 800, 900 has a diameter of less than 1 mm and the diameter of the shaft can be about 0.7 mm. Further, the shaft 408, 508, 608, 708, 808, 908 and the cavity 410, 510, 610, 710, 810, 910 can be configured so that a force of at least 5 N is required for uncoupling and a force of between about 10 N to about 15 is required for coupling.

[0154] FIG. 10 illustrates a method 1000 for operating a suturing device according to some embodiments. The method 1000 is illustrated as a set of operations or processes 1002 through 1010. Not all of the illustrated processes may be performed in all embodiments of the method 1000. Additionally, one or more processes that are not expressly illustrated in FIG. 10 may be included before, after, in between, or as part of the processes 1002 through 1010. Processes may also be performed in different orders. In some embodiments, one or more of the processes 1002 through 1010 may be implemented, at least in part, in the form of executable code stored on non-transitory, tangible, machine-readable media that when run by one or more processors (e.g., the processors of a controller) may cause the one or more processors to perform one or more of the processes. In one or more embodiments, the processes 1002 through 1010 may be performed by a controller.

[0155] The method 1000 includes assembling an arcuate needle. In process 1002, a shaft (e.g., shaft 408, 508, 908) is inserted into a cavity (e.g., cavity 410, 510, 910) to connect a needle tip (e.g., needle tip 402, 502, 902) and needle body (e.g., needle body 404, 504, 904) together. In process 1004, a flexure member (e.g., flexure member 418, 518, 918) of a detent (e.g., detent 412, 512, 912) is deformed as the shaft is inserted into the cavity. In process 1006, a catch (e.g., catch 416, 516, 916) of the detent is inserted into a notch (e.g., notch 414, 514, 914) with the flexure member to secure the needle tip to the needle body. Processes 1002-1006 can be utilized to assemble an arcuate needle (e.g., needle 400, 500, 900) together.

[0156] In process 1008, a thread is coupled to the needle tip via one or more suture openings (e.g., suture opening 436, 536, 936) defined in the needle tip. In process 1010, the needle tip and the needle body are disconnected. In some examples, disconnection of the needle tip and the needle allows the needle tip to be utilized as a suture anchor. The method 1000 can also include operating a needle driver device to spin the needle to create a suture in tissue.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0157] For purposes of illustration, and not limitation, a representative implementation of a suturing device is presented in FIGS. 11 A-l 1H. A directional axis is depicted indicating proximal and distal directions with reference to device 1100. The depicted directional axis applied in kind to the other figures in the present disclosure.

[0158] The suturing device 1100 of FIG. 11A includes a housing 1110 that defines an arcuate needle track 1120. The arcuate needle track 1120 has a first end 1122 and a second end 1124. The housing 1110 further defines a gap 1112 between the first end 1122 and second end 1124 of the arcuate needle track 1120. The gap 1112 is configured to receive a tissue sample therein to be sutured, discussed in further detail below. The suturing device 1100 further includes a drive system 1130 to advance an arcuate needle 1180 about the arcuate needle track 1120 and across the gap 1112 along a first direction A as indicated by an arrow. In some example consistent with FIGS.4A-9D, the needle 1180 can correspond to the needle 400, 500, 600, 700, 800, 900.

[0159] FIG. 11A presents an isometric upper view of the suturing device 1100. The suturing device includes cable sheaths 1174A, 1174B containing inner sleeves 1172A, 1172B to route proximal drive elongate flexible member portions 1156A, 1156B (e.g., tension cables) to one or more proximally located actuators, such as hand actuated devices or an automated or robotic surgical system. The drive system 1130 includes a drive member operably coupled to an elongate flexible member (not shown) via a shuttle 1140. The return side can be spring loaded such that only one direction of shuttle movement needs to be actively actuated, and upon releasing tension on that side the shuttle 1140 can be pulled back into its starting position due to a persistent spring force. The shuttle 1140 can include a compressible body therein that urges the drive member (such as a pawl, pin, protrusion, belt tooth or the like) into contact with the needle 1180.

[0160] An endoscope 1190 suitable for the suturing device 1100 can be a standard endoscope that is removably received by a retainer of the suturing device 1100 such as a split clamping sleeve 1119 formed at a proximal end of the suturing device. The proximal section of the housing 1110 and the distal portion of the housing 1110 containing the needle track 1120 can be integrally formed in a manner that the bore of the sleeve is oriented obliquely with respect to a plane defined by a centerline of the needle 1180 when it is situated in the needle track 1120. The needle drive system 1130, discussed in further detail below, provides functionality to effect movement of the needle about the needle track 1120 to advance the needle 1180 through tissue to be sutured that is present within the gap 1112. FIG. 11C presents a further isometric view underneath the suturing device 1100 illustrating relative placement of a cable routing system that includes inner and outer sleeves / sheaths 1172A, 1172B and 1174A, 1174B respectively for each length of cable. In certain embodiments, inner sleeve 1172A, 1172B is a polytetrafluoroethylene (PTFE) tube. In certainIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC embodiments, outer sleeve 1174A, 1174B is a coil pipe or coil tube, which may be embedded in a polymer tube, allowing it to take compressive loads while remaining flexible.

[0161] FIG. 1 ID presents a further isometric upper view of the suturing device 1100. From this angle, the first end 1122 of the needle track 1120 is visible. An upper arcuately shaped plate / surface 1162 of a removable cover that covers the needle track 1120 is also apparent. The plate 1162 is joined about a “U” shaped inner periphery to a downwardly depending wall formed from an arcuate segment 1164 that extends distally into two straight wall sections 1166A that extend to a distal end face of the housing 1110 when the cover is installed in the housing 1110. FIG. HE presents an enlarged upper isometric view of the suturing device 1100. FIG. HF presents a transparent view of the suturing device revealing the relative locations of internal components including pulleys, elongate flexible members / cables and the like. FIG. 11G depicts a view of the suturing device 1100 with the needle 1180 removed. FIG. 11H presents a plan distal view of the suturing device 1100 with the endoscope 1190 disposed therein. As can be observed in this distal plan view, the device distally projects a shape of a circle, or nearly so.

[0162] One or more components of the embodiments discussed in this disclosure, such as control system 112, may be implemented in software for execution on one or more processors of a computer system. The software may include code that when executed by the one or more processors, configures the one or more processors to perform various functionalities as discussed herein. The code may be stored in a non-transitory computer readable storage medium (e.g., a memory, magnetic storage, optical storage, solid-state storage, etc.). The computer readable storage medium may be part of a computer readable storage device, such as an electronic circuit, a semiconductor device, a semiconductor memory device, a read only memory (ROM), a flash memory, an erasable programmable read only memory (EPROM); a floppy diskette, a CD-ROM, an optical disk, a hard disk, or other storage device. The code may be downloaded via computer networks such as the Internet, Intranet, etc. for storage on the computer readable storage medium. The code may be executed by any of a wide variety of centralized or distributed data processing architectures. The programmed instructions of the code may be implemented as a number of separate programs or subroutines, or they may be integrated into a number of other aspects of the systems described herein. The components of the computing systems discussed herein may be connected using wired and / or wireless connections. In some examples, the wireless connections may use wireless communication protocols such as Bluetooth, near-field communication (NFC), Infrared Data Association (IrDA), home radio frequency (HomeRF), IEEE 802.11, Digital Enhanced Cordless Telecommunications (DECT), and wireless medical telemetry service (WMTS).Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC

[0163] Various general-purpose computer systems may be used to perform one or more processes, methods, or functionalities described herein. Additionally or alternatively, various specialized computer systems may be used to perform one or more processes, methods, or functionalities described herein. In addition, a variety of programming languages may be used to implement one or more of the processes, methods, or functionalities described herein.

[0164] While certain embodiments and examples have been described above and shown in the accompanying drawings, it is to be understood that such embodiments and examples are merely illustrative and are not limited to the specific constructions and arrangements shown and described, since various other alternatives, modifications, and equivalents will be appreciated by those with ordinary skill in the art.

Claims

Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC What is claimed is:

1. A medical device comprising:an arcuate needle comprising a needle body and a needle tip, the needle body and the needle tip configured to releasably couple together via a coupling including a shaft and cavity; and a detent of the coupling configured to hold the shaft and cavity together, the detent comprising a notch, a catch, and a flexure member configured to resiliently deform and subsequently insert the catch into the notch when the needle body and needle tip are fully coupled together.

2. The medical device of claim 1 , wherein the shaft comprises a ramp to deform the flexure member while the shaft is being inserted into the cavity.

3. The medical device of claim 2, wherein an angle of a retention surface of the notch is steeper than an angle of the ramp.

4. The medical device of claim 2, wherein an engagement surface of the catch and a retention surface of the notch disposed adjacent to the ramp are misaligned.

5. The medical device of claim 2, wherein the catch comprises an engagement surface defined by the flexure member; and the notch comprises a retention surface disposed adjacent to the ramp, one of the engagement surface or the retention surface being curved and the other of the engagement surface or the retention surface being planar.

6. The medical device of any one of claims 1 to 5, wherein the flexure member comprises a portion of a wall at least partially defining the cavity.

7. The medical device of any one of claims 1 to 5, wherein the needle tip defines the cavity, the catch, and the flexure member; and the needle body comprises the shaft defining the notch.

8. The medical device of any one of claims 1 to 4, wherein the flexure member comprises an elastomer.

9. The medical device of claim 8, wherein the needle tip defines the cavity and comprises the catch extending into the cavity; and the needle body comprises the shaft, the shaft including a base, the flexure member coupled to the base, and an engagement member coupled to the flexure member, the engagement member defining the notch.

10. The medical device of any one of claims 1 to 5, wherein the cavity and the shaft comprise one or more engagement features to resist relative rotation when the shaft is inserted into the cavity.

11. The medical device of claim 1 , wherein the shaft comprises a main portion and the flexure member, the flexure member angled away from the main portion as the flexure member extends main portion; and notch is defined in a sidewall defining the cavity.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC 12. The medical device of claim 11, wherein the flexure member extends at a plurality of angles relative to the main portion of the shaft.

13. The medical device of claim 11, wherein the catch comprises a distal end of the flexure member and the notch is defined in the sidewall of defining the cavity adjacent to an end thereof.

14. The medical device of claim 2, wherein the flexure member comprises a protrusion sized to be at least partially received within the notch.

15. The medical device of any one of claims 11 to 14, wherein the flexure member is welded to the main portion of the shaft.

16. The medical device of any one of claims 11 to 14, wherein the needle tip defines the cavity and notch; and the needle body comprises the shaft including the flexure member with the catch at a distal end thereof.

17. The medical device of any one of claims 11 to 14, wherein the cavity and the shaft comprise one or more corresponding engagement features to resist relative rotation when the shaft is inserted into the cavity.

18. A method for operating a suturing device, the method comprising:assembling an arcuate needle by:inserting a shaft into a cavity to connect a needle tip and needle body together; deforming a flexure member of a detent as the shaft is inserted into the cavity; and inserting a catch of the detent into a notch with the flexure member to secure the needle tip to the needle body.

19. The method of claim 18, wherein deforming the flexure member comprises driving the catch up a ramp of the shaft as the shaft is inserted into the cavity.

20. The method of claim 19, wherein inserting the catch of the detent into the notch comprises the flexure member resiliently returning to shape to insert the catch into the notch disposed adjacent to the ramp.

21. The method of any one of claims 18 to 20, wherein deforming the flexure member comprises flexing a portion of a wall at least partially defining the cavity outwardly as the shaft is inserted into the cavity.

22. The method of any one of claims 18 to 20, wherein deforming the flexure member comprises deforming an elastomer of the shaft, the shaft comprising the notch coupled to the elastomer.

23. The method of any one of claims 18 to 20, further comprising securing a thread to the needle tip through a suture opening defined therethough.Intuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC 24. The method of claim 23, further comprising disconnecting the needle tip from the needle body.

25. The method of claim 18, wherein deforming the flexure member comprises deflecting the flexure member towards a main body of the shaft as the shaft is inserted into the cavity.

26. The method of claim 25, wherein inserting the catch of the detent into the notch comprises the flexure member resiliently returning to shape away from the main body of the shaft to insert the catch into the notch defined in a sidewall of the cavity.

27. The method of claim 26, wherein inserting the catch of the detent into the notch further comprises inserting a lip of the flexure member into the notch.

28. The method of any one of claims 25 to 27, further comprising securing a thread to the needle tip through a suture opening defined therethough.

29. The method of claim 28, further comprising disconnecting the needle tip from the needle body.

30. A medical device comprising:an arcuate needle comprising a needle body and a needle tip, the needle body and the needle tip configured to releasably couple together via a coupling including a shaft and cavity; and one or more tapered friction surfaces of the coupling configured to result in increasing forces as the shaft is inserted into the cavity.

31. The medical device of claim 30, wherein the shaft has a forked configuration with interior surfaces tapered to reduce spacing therebetween; and the coupling further comprises a bar extending across the cavity, the interior surface of the shaft configured to engage the bar when the shaft is inserted into the cavity.

32. The medical device of claim 30, wherein the shaft comprises an annular protrusion extending therearound, the protrusion having a rearwardly tapered surface configured to engage an interior surface of the cavity when the shaft is inserted into the cavity.

33. The medical device of any one of claims 30 to 32, wherein the needle tip defines the cavity and the needle body comprises the shaft.

34. The medical device of claim 33, wherein the needle tip further defines one or more recesses adjacent to the cavity such that the coupling is tolerant of debris.

35. A medical device comprising:an arcuate needle comprising a needle body and a needle tip, the needle body and the needle tip configured to releasably couple together via a friction fit coupling including a shaft and cavity; andIntuitive Docket No.: P06972-WO Attorney Docket No.: 33685 / 70603 PC a detent of the coupling configured to hold the shaft and cavity together, the detent comprising one or more bars extending at least partially into an interior of the cavity, and a contoured surface of the shaft configured to engage the one or more bars to hold the needle body and needle tip together.

36. The medical device of claim 35, wherein the shaft has a forked configuration with interior surfaces tapered to reduce spacing therebetween; and the coupling further comprises a bar extending across the cavity, the interior surface of the shaft configured to engage the bar when the shaft is inserted into the cavity.

37. The medical device of claim 35, wherein the coupling includes opposing protrusions extending into the cavity; and the shaft defines opposing grooves to receive the protrusions therein when the shaft is fully inserted into the cavity.

38. The medical device of any one of claims 35 to 37, wherein the needle tip defines the cavity and the needle body comprises the shaft.

39. The medical device of claim 38, wherein the needle tip further defines one or more recesses adjacent to the cavity such that the coupling is tolerant of debris.

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