阅读说明：本技术 用于储存缝合针以及使用机器人递送选定的缝合针穿过套管针的系统、装置和方法 (Systems, devices, and methods for storing suture needles and delivering selected suture needles through trocars using a robot ) 是由 C·韦尔赫 D·苏尔斯 于 2020-02-19 设计创作，主要内容包括：本发明公开了一种缝合针容器,该缝合针容器包括接受器,该接受器具有带有开口的近侧端部和封闭的远侧端部。中空心轴设置在接受器内部。心轴从封闭的远侧端部朝向接受器的近侧端部处的开口突出。心轴包括管状壁,该管状壁具有与接受器的近侧端部对准的近侧端部和与接受器的封闭的远侧端部连接的远侧端部。细长狭槽形成在管状壁中。缝合针设置在细长狭槽内。缝合线固定到缝合针的近侧端部并且缠绕在中空心轴周围。覆盖件封闭接受器的近侧端部处的开口,以用于将缝合针和缝合线密封在接受器内,并且用于维持接受器内部的无菌环境。(A suture needle container includes a receptacle having a proximal end with an opening and a closed distal end. A hollow mandrel is disposed inside the receptacle. The mandrel protrudes from the closed distal end toward an opening at the proximal end of the receptacle. The mandrel includes a tubular wall having a proximal end aligned with the proximal end of the receptacle and a distal end connected with the closed distal end of the receptacle. An elongated slot is formed in the tubular wall. A suture needle is disposed within the elongated slot. The suture is secured to the proximal end of the suture needle and is wrapped around the hollow mandrel. The cover closes an opening at the proximal end of the receptacle for sealing the suture needle and suture within the receptacle and for maintaining a sterile environment inside the receptacle.)

1. A suture needle container comprising:

a receptacle having a proximal end with an opening and a distal end closed by an end wall;

a mandrel located inside the receptacle, the mandrel having a tubular wall protruding from the end wall of the receptacle toward the opening at the proximal end of the receptacle;

an elongated slot formed in the tubular wall of the mandrel, the elongated slot extending from a proximal end of the tubular wall toward the end wall of the receptacle;

a suture needle disposed within the elongate slot, wherein the suture needle has a distal end disposed inside the tubular wall of the mandrel and a proximal end disposed outside the tubular wall of the mandrel;

a cover sealing the opening at the proximal end of the receptacle, the cover maintaining a sterile environment inside the receptacle.

2. The suture needle container of claim 1, wherein the receptacle comprises a cylindrical outer wall extending between the proximal and distal ends of the receptacle.

3. The suture needle container of claim 2, wherein the cylindrical outer wall surrounds the mandrel, and the tubular wall of the mandrel is centrally located inside the cylindrical outer wall.

4. The suture needle container of claim 1, wherein the tubular wall of the mandrel has a distal end connected with the end wall of the receptacle and a proximal end substantially aligned with the proximal end of the receptacle.

5. The suture needle container of claim 4, wherein the elongated slot formed in the tubular wall of the mandrel is open at the proximal end of the tubular wall, and the elongated slot has a closed end proximal to and spaced from the end wall of the receptacle.

6. The suture needle container of claim 5, wherein the distal end of the suture needle comprises a tapered section that terminates at a tip defining a distal-most end of the suture needle, and wherein the tip is located inside the tubular wall of the mandrel and the tapered section of the suture needle passes through the elongated slot formed in the tubular wall of the mandrel.

7. The suture needle container of claim 6, wherein a distal portion of the tapered section of the suture needle is disposed inside the tubular wall of the mandrel and a proximal portion of the suture needle is disposed outside the tubular wall of the mandrel and inside the receptacle.

8. The suture needle container of claim 4, wherein the tubular wall of the mandrel defines a needle driver guide slot having a height and a width, the needle driver guide slot extending from the proximal end of the tubular wall of the mandrel to the distal end of the tubular wall of the mandrel.

9. The suture needle container of claim 8 further comprising a needle driver comprising an elongate shaft having a distal end with a clamp assembly having a lower jaw and an upper jaw movable between an open position and a closed position, wherein the lower jaw and the upper jaw in the open position define an open jaw height matching the height of the needle driver guide slot and the lower jaw and the upper jaw define a jaw width matching the width of the needle driver guide slot.

10. The suture needle container of claim 9, wherein the needle driver guide channel has a floor at a lower end of the needle driver guide channel, a ceiling at an upper end of the needle driver guide channel, and opposing sidewalls extending between the floor and the ceiling, wherein the elongated slot is formed in one of the opposing sidewalls, and wherein the floor has a surface that conforms to an underside of the elongated shaft of the needle driver.

11. The suture needle container of claim 10, wherein the elongate shaft has an outer diameter, and wherein the elongate slot is spaced from the floor of the needle driver guideway by a distance greater than, and of the outer diameter of the elongate shaft of the needle driver.

12. The suture needle container of claim 9, wherein the lower jaw has a distal end and a top surface adapted to engage the distal portion of the tapered section of the suture needle disposed inside the tubular wall of the mandrel, wherein the top surface of the lower jaw has a length greater than a distance between the closed end of the elongated slot and the end wall of the receptacle for aligning the tip of the suture needle on the top surface of the lower jaw when the distal end of the lower jaw abuts the end wall of the receptacle.

13. The suture needle container of claim 1, wherein the cover sealing the opening at the proximal end of the receptacle comprises a material selected from the group consisting of: foil, polymer, plastic, high density polyethylene, and Tyvek.

14. A suture needle container comprising:

a receptacle having a proximal end with an opening and a closed distal end;

a hollow mandrel disposed inside the receptacle, the hollow mandrel protruding from the closed distal end of the receptacle toward the opening at the proximal end of the receptacle, the hollow mandrel comprising a tubular wall having a proximal end aligned with the proximal end of the receptacle and a distal end connected with the closed distal end of the receptacle;

an elongated slot formed in the tubular wall of the hollow mandrel, the elongated slot extending from the proximal end of the tubular wall to a location proximal to and spaced from the closed distal end of the receptacle;

a suture needle disposed within the elongated slot, wherein the suture needle has a distal end with a tip disposed inside the tubular wall of the hollow mandrel and a proximal end disposed outside the tubular wall of the hollow mandrel;

a suture secured to the proximal end of the suture needle and wrapped around the hollow mandrel;

a cover closing the opening at the proximal end of the receptacle for sealing the suture needle and suture inside the receptacle and maintaining a sterile environment inside the receptacle.

15. The suture needle container of claim 14, wherein the tubular wall of the hollow mandrel defines a needle driver guide slot having a height and a width, the needle driver guide slot extending from the proximal end of the tubular wall of the hollow mandrel to the distal end of the tubular wall of the hollow mandrel.

16. The suture needle container of claim 15 further comprising a needle driver comprising an elongate shaft having a distal end with a clamp assembly having a lower jaw and an upper jaw movable between an open position and a closed position, wherein the lower jaw and the upper jaw in the open position define an open jaw height matching the height of the needle driver guide slot and the lower jaw and the upper jaw define a jaw width matching the width of the needle driver guide slot.

17. The suture needle container of claim 16, wherein the needle driver guide channel has a floor at a lower end of the needle driver guide channel, a ceiling at an upper end of the needle driver guide channel, and opposing sidewalls extending between the floor and the ceiling, wherein the elongated slot is formed in one of the opposing sidewalls and is closer to the floor than the ceiling of the needle driver guide channel.

18. The suture needle receptacle of claim 17, wherein the elongate shaft of the needle driver has an outer diameter, and wherein the elongate slot formed in the tubular wall of the hollow mandrel is spaced from the floor of the needle driver guideway by a distance greater than, and of the outer diameter of the elongate shaft of the needle driver.

19. The suture needle container of claim 18, wherein the lower jaw has a distal end and a top surface adapted to engage the distal portion of the tapered section of the suture needle disposed inside the tubular wall of the mandrel, wherein the top surface of the lower jaw has a length greater than a distance between the closed end of the elongated slot and the closed distal end of the receptacle for aligning the tip of the suture needle on the top surface of the lower jaw when the distal end of the lower jaw abuts the closed distal end of the receptacle.

20. The suture needle container of claim 14, wherein the distal end of the suture needle comprises a tapered section that terminates at the tip defining a distal-most end of the suture needle, and wherein the tip is located inside the tubular wall of the hollow mandrel and the tapered section of the suture needle passes through the elongated slot formed in the tubular wall of the hollow mandrel.

21. A surgical method, comprising:

disposing a plurality of suture needle containers in a surgical environment;

each of the suture needle containers includes: a receptacle having a proximal end with an opening and a distal end closed by an end wall; a mandrel located inside the receptacle, the mandrel having a tubular wall protruding from the end wall toward the opening at the proximal end of the receptacle; an elongated slot formed in the tubular wall of the mandrel, the elongated slot extending from a proximal end of the tubular wall toward the end wall of the receptacle; a suture needle disposed within the elongate slot, the suture needle having a distal end disposed inside the tubular wall and a proximal end disposed outside the tubular wall; and a cover sealing the opening at the proximal end of the receptacle for maintaining a sterile environment inside the receptacle;

after selecting one of the needles inside one of the needle containers for use, causing a controller on a surgical robotic system to transmit input instructions to an electromechanical tool to: breaking the cover of a selected one of the suture needle receptacles; securing the distal end of the selected one of the suture needles; and removing the fixed suture needle from the broken suture needle container.

22. The surgical method of claim 21, further comprising causing the controller of the surgical robotic system to transmit input instructions to the electromechanical tool to advance the fixed suture needle through a trocar.

Technical Field

The present patent application relates generally to surgical systems and tools and, more particularly, to systems, devices, and methods for using a robot to deliver a suture needle through a trocar during minimally invasive surgery.

Description of the Related Art

Minimally Invasive Surgical (MIS) instruments and solutions are generally superior to traditional open surgical devices due to reduced post-operative recovery time and minimal scarring. Laparoscopic surgery is a type of MIS procedure in which one or more small incisions are made in the abdomen and a trocar is inserted through the incision to create access to the abdominal cavity. Trocars are used to introduce various instruments and tools, such as suture needles for suturing tissue, into the abdominal cavity.

The size of a suture needle (e.g., a needle attached to a suture) or a surgical needle (e.g., a needle not attached to a suture) that can be passed through a trocar to reach a surgical site is often limited by the size of the opening in the trocar. In many instances, surgeons desire to use larger needles to close surgical wounds and repair anatomical features, however, passing larger needles through smaller trocars is difficult. For example, a 5mm trocar is often used during Minimally Invasive Surgery (MIS), however, surgeons are unable to pass larger suture needles through a 5mm trocar, thus forcing them to use only smaller suture needles.

Smaller suture needles are less desirable because they often require, among other things, the surgeon to pass the needle and suture through the tissue more often, which lengthens the surgery and can be unpleasant for the surgeon. The use of smaller needles may also create a bite distance that exposes the wound or anatomical feature to the risk of dehiscence.

In addition, larger sutures cannot be easily attached to smaller needles. Thus, when a fine suture is passed through tissue with a small bite size, a cheese silk effect may be created whereby the suture cuts through the tissue intended to be held.

While conventional minimally invasive surgical instruments and techniques have proven to be highly effective, newer systems may provide even more advantages. For example, conventional minimally invasive surgical instruments often fail to provide surgeons with the flexibility of tool placement that exists in open surgery. Difficulties are encountered in accessing the surgical site through small incisions using instruments. In addition, the increased length of typical endoscopic instruments often reduces the surgeon's ability to feel the forces exerted by the tissues and organs on the end effector. Furthermore, coordination of the movement of the end effector of the instrument viewed in the image on the television monitor with the actual end effector movement is particularly difficult because the perceived movement in the image does not typically correspond intuitively to the actual end effector movement. As a result, intuitive responses to surgical instrument movement inputs are often lacking. Such lack of intuition, dexterity and sensitivity of endoscopic tools has been found to be an obstacle to increased use of minimally invasive surgery.

Over the years, a variety of minimally invasive robotic systems have been developed to increase the dexterity of the surgical procedure and to allow the surgeon to operate on the patient in an intuitive manner. Tele-surgery is a general term for surgery performed using a system in which the surgeon uses some form of remote control (e.g., servomechanism, etc.) to manipulate the movement of the surgical instrument, rather than directly holding and moving the tool by hand. In such telesurgical systems, the surgeon is typically provided with an image of the surgical site on a visual display at a location remote from the patient. The surgeon may typically perform the surgical procedure at a location remote from the patient while viewing the end effector movement on the visual display during the surgical procedure. Typically, while viewing a three-dimensional image of the surgical site on a visual display, the surgeon performs the surgical procedure on the patient by manipulating a master control device at a remote location that controls the motion of the remotely controlled instrument.

While significant advances have been made in the fields of minimally invasive surgery and robotic surgery, there remains a need for improved systems, methods, and devices for: enabling a surgeon to select from a range of available suture needles having different properties and performance characteristics and using an automated system (such as a robot) to advance the selected suture needle through a trocar for use at a surgical site.

Background

Disclosure of Invention

In one embodiment, a suture needle container preferably includes a receptacle having a proximal end with an opening and a distal end closed by an end wall. In one embodiment, the receptacle preferably comprises a cylindrical outer wall extending between the proximal and distal ends of the receptacle. In one embodiment, the receptacle may have a pot shape with an open proximal end and a closed distal end.

In one embodiment, the mandrel is located inside the receptacle. In one embodiment, the mandrel has a tubular wall projecting from the end wall of the receptacle towards the opening at the proximal end of the receptacle.

In one embodiment, the tubular wall of the mandrel preferably has a distal end connected to the end wall of the receptacle and a proximal end substantially aligned with the proximal end of the receptacle.

In one embodiment, the cylindrical outer wall preferably surrounds the mandrel, and the tubular wall of the mandrel is centrally located inside the cylindrical outer wall.

In one embodiment, an elongate slot is desirably formed in the tubular wall of the mandrel, the elongate slot extending from the proximal end of the tubular wall toward the end wall of the receptacle.

In one embodiment, the elongate slot formed in the tubular wall of the mandrel is open at the proximal end of the tubular wall, and the elongate slot has a closed end proximal to and spaced from the end wall of the receptacle.

In one embodiment, the suture needle is preferably disposed within the elongated slot. The suture needle desirably has a distal end disposed inside the tubular wall of the mandrel and a proximal end disposed outside the tubular wall of the mandrel.

In one embodiment, the suture needle is preferably made of an elastic, highly elastic or superelastic material, such as nitinol. In one embodiment, the needle can be elastically deformed to reduce the height and/or profile of the needle to allow the needle to pass through a trocar, such as a trocar having a diameter of 5mm or less. In one embodiment, an external force may be applied to the suture needle to elastically deform the suture needle (e.g., when passing the suture needle through a trocar), and the suture needle will desirably spring back to its original shape and/or configuration when the external force is removed.

In one embodiment, the suture needle defines a curved element, such as an elongated body having a semi-circular or semi-circular shape. In one embodiment, the suture needle defines 1/4 circles, 3/8 circles, 5/8 circles, 3/4 circles, and the like.

In one embodiment, the suture needle may have a bendable region or may be highly elastic for changing shape and/or configuration to fit through a trocar (e.g., a 5mm trocar), as disclosed in commonly assigned U.S. patent application serial No. ________ (ETH6024USNP1, ETH6025USNP1, and ETH6026USPSP), the disclosures of which are incorporated herein by reference.

In one embodiment, the cover preferably seals the opening at the proximal end of the receptacle to maintain a sterile environment inside the receptacle.

In one embodiment, the distal end of the suture needle preferably includes a tapered section that terminates at a tip defining the distal-most end of the suture needle. In one embodiment, when the suture needle is held within the elongate slot of the mandrel, the tip of the suture needle is located within the tubular wall of the mandrel, and the tapered section of the suture needle desirably passes through the elongate slot formed in the tubular wall of the mandrel.

In one embodiment, a distal portion of the tapered section of the suture needle is disposed inside the tubular wall of the mandrel and a proximal portion of the suture needle is disposed outside the tubular wall of the mandrel and inside the receptacle.

In one embodiment, the tubular wall of the mandrel preferably defines a needle driver guide slot having a height and a width. In one embodiment, the needle driver guide slot extends from a proximal end of the tubular wall of the mandrel to a distal end of the tubular wall of the mandrel.

In one embodiment, a needle driver may be used to remove a suture needle from an elongated slot of a mandrel. In one embodiment, the needle driver preferably includes an elongate shaft having a distal end with a clamp assembly having a lower jaw and an upper jaw movable between an open position and a closed position. In one embodiment, the jaws define an open jaw height that matches a height of the needle driver guide channel when the lower and upper jaws are in the open position. In addition, the lower and upper jaws preferably define a jaw width that matches the width of the needle driver guide slot.

In one embodiment, a needle driver may be used to secure the tapered section at the distal end of the suture needle, with the tube of the suture needle following the tip of the suture needle. In one embodiment, the tip is preferably surrounded by a gripping jaw at the distal end of the needle driver for protecting the tip as the suture needle passes through the trocar. The clamping jaws preferably surround and protect the tip to prevent the tip from contacting the interior of the trocar as it passes through the trocar, which could damage the tip during passage of the tip through the trocar.

In one embodiment, when the suture needle is held by the needle driver, the tip of the needle does not extend or protrude outside the outer surface of the needle holder. In one embodiment, the tapered section of the suture needle preferably extends along an axis defining an angle of less than 90 degrees with respect to a longitudinal axis of the needle driver alignment passage, which preferably enables the suture needle to pass through the trocar with less force.

In one embodiment, the needle driver channel preferably has a bottom plate at a lower end of the needle driver channel, a top plate at an upper end of the needle driver channel, and opposing side walls extending between the bottom plate and the top plate. In one embodiment, the elongated slot of the mandrel is desirably formed in one of the opposing sidewalls. In one embodiment, the floor of the needle driver guide channel preferably has a surface (e.g., a concave surface) that conforms to the underside (e.g., a cylindrical surface) of the elongated shaft of the needle driver.

In one embodiment, the elongate shaft of the needle driver preferably has an outer diameter, and the elongate slot formed in the mandrel is preferably spaced from the floor of the needle driver guide slot by a distance greater than 1/2 of the outer diameter of the elongate shaft of the needle driver.

In one embodiment, the lower jaw of the needle driver preferably has a distal end and a top surface adapted to engage a tapered section of a suture needle disposed within the tubular wall of the mandrel. In one embodiment, the top surface of the lower jaw has a length greater than a distance between the closed end of the elongated slot and the end wall of the receptacle. In one embodiment, the tip of the suture needle is preferably aligned on the top surface of the lower jaw when the distal end of the lower jaw abuts the end wall of the receptacle.

In one embodiment, the cover sealing the opening at the proximal end of the receptacle may be made of foil, polymer, plastic, high density polyethylene, and/or Tyvek.

In one embodiment, the suture needle container preferably includes a receptacle having a proximal end with an opening and a closed distal end and a hollow mandrel disposed inside the receptacle. In one embodiment, the mandrel preferably protrudes from the closed distal end of the receptacle towards the opening at the proximal end of the receptacle.

In one embodiment, the hollow mandrel desirably comprises: a tubular wall having a proximal end aligned with the proximal end of the receptacle and a distal end connected with the closed distal end of the receptacle; and an elongate slot formed in the tubular wall of the hollow mandrel, the elongate slot extending from a proximal end of the tubular wall to a location proximal to and spaced from the closed distal end of the receptacle.

In one embodiment, the suture needle may be disposed within the elongated slot. In one embodiment, the suture needle preferably has a distal end with a tip disposed inside the tubular wall of the hollow mandrel and a proximal end disposed outside the tubular wall of the hollow mandrel when the suture needle is retained within the elongated slot. In one embodiment, the suture is secured to the proximal end of the suture needle, and the suture has a length that wraps around the hollow mandrel.

In one embodiment, the cover preferably closes an opening at the proximal end of the receptacle for sealing the suture needle and suture within the receptacle and for maintaining a sterile environment inside the receptacle. The cover preferably forms a hermetic seal over the opening of the receptacle.

In one embodiment, the tubular wall of the hollow mandrel preferably defines a needle driver channel having a height and a width. In one embodiment, the needle driver guide slot desirably extends from the proximal end of the tubular wall of the hollow shaft to the distal end of the tubular wall of the hollow mandrel.

In one embodiment, a needle driver may be used to remove the suture needle from the suture needle container. In one embodiment, the needle driver desirably includes an elongate shaft having a distal end with a clamping assembly having a lower jaw and an upper jaw movable between an open position and a closed position.

In one embodiment, the lower jaw and the upper jaw in the open position define an open jaw height that matches a height of the needle driver guide channel. In one embodiment, the lower jaw and the upper jaw define a jaw width matching a width of the needle driver guide channel.

In one embodiment, the needle driver channel preferably has a bottom plate at a lower end of the needle driver channel, a top plate at an upper end of the needle driver channel, and opposing side walls extending between the bottom plate and the top plate. In one embodiment, the elongated slot is formed in one of the opposing side walls and is closer to the floor than the top plate of the needle driver channel.

In one embodiment, the elongate shaft of the needle driver desirably has an outer diameter. In one embodiment, the elongate slot formed in the tubular wall of the hollow mandrel is preferably spaced from the floor of the needle driver guide slot by a distance greater than 1/2 of the outer diameter of the elongate shaft of the needle driver.

In one embodiment, the lower jaw preferably has a distal end and a top surface adapted to engage a distal portion of a tapered section of a suture needle disposed within the tubular wall of the mandrel. In one embodiment, the top surface of the lower jaw has a length greater than a distance between the closed end of the elongated slot and the closed distal end of the receptacle, which facilitates consistent alignment of the tip of the suture needle above the top surface of the lower jaw when the distal end of the lower jaw abuts the closed distal end of the receptacle.

In one embodiment, the distal end of the suture needle may include a tapered section that terminates at a tip defining the distal-most end of the suture needle. In one embodiment, when the suture needle is secured within an elongate slot formed in the tubular wall of the mandrel, the tip desirably is located inside the tubular wall of the hollow mandrel, and the tapered section of the suture needle preferably passes through the elongate slot.

In one embodiment, a scaffold assembly comprising a plurality of medical devices used during a surgical procedure can be oriented in a substantially planar or vertical configuration. The rack assembly may have a plurality of removably attachable medical devices or tools (e.g., end effectors and/or objects for use with end effectors). The location of each of the devices is preferably predetermined and catalogued in the robot or computer control system. The surgical robotic arm preferably interacts with a computer control system to position and retrieve devices (e.g., suture needle capsule, suture needle, needle drive) from the rack, as needed.

In one embodiment, the rack may be made to automatically position a medical device desired to be coupled to the robotic arm in a known and convenient location.

In one embodiment, one or more of the devices (e.g., suture needle capsule) may be encoded (e.g., barcode, RFID chip, etc.) so that the robotic system and robotic arm can determine what the device is and/or confirm that the device is the one that is expected to be seen at a given location. The device may be selected from a wide variety of surgical tools, such as a suture needle receptacle, a suture needle, a suture, and/or a plant. The device may be enclosed within a sterile container or chamber whereby the robotic arm may easily retrieve the device through the frangible barrier.

In one embodiment, the surgical method may use a robot to perform the following operations: loading a suture needle onto a surgical tool, such as a needle driver; removing the loaded suture needle from the suture needle container; and passing the loaded suture needle through the trocar for positioning the suture needle at the surgical site.

In one embodiment, a surgical method preferably includes arranging a plurality of suture needle containers in a surgical environment (e.g., positioning the suture needle containers within a matrix having rows and columns), whereby each suture needle container desirably includes: a receptacle having a proximal end with an opening and a distal end closed by an end wall; a mandrel located inside the receptacle, the mandrel having a tubular wall projecting from the end wall towards an opening at the proximal end of the receptacle; an elongate slot formed in the tubular wall of the mandrel, the elongate slot extending from the proximal end of the tubular wall towards the end wall of the receptacle; a suture needle disposed within the elongate slot, the suture needle having a distal end disposed inside the tubular wall and a proximal end disposed outside the tubular wall; and a cover sealing the opening at the proximal end of the receptacle for maintaining a sterile environment inside the receptacle.

In one embodiment, a surgical method preferably includes, after selecting one of the needles inside one of the needle containers for use, causing a controller on the surgical robotic system to transmit input instructions to the electromechanical tool to: breaking a cover of a selected one of the suture needle receptacles; securing a distal end of a selected one of the suture needles; and removing the fixed suture needle from the broken suture needle container.

In one embodiment, a surgical method can include causing a controller of a surgical robotic system to transmit an input command to an electromechanical tool to advance a stationary suture needle through a trocar.

In one embodiment, a suture needle container preferably includes a centrally located mandrel having a needle driver guide slot formed therein, the needle driver guide slot having a shape and size to engage an outer surface of a distal end of a needle driver for controlling a direction and angle of a needle holder when loading a suture needle onto the distal end of the needle driver.

In one embodiment, the internal geometry of the needle driver guide channel preferably matches the geometry of the needle holder when the lower and upper jaws at the distal end of the needle holder are in the open position.

In one embodiment, a distal end of the lower jaw of the needle holder abuts a stop plate for consistently aligning the gripping surface of the lower jaw with the distal end of the needle retained within the needle driver guide slot.

In one embodiment, the mandrel defining the needle driver guide slot has an elongated slot formed therein, whereby the suture needle is retained in the elongated slot and slides out of the elongated slot for removal from the suture needle container.

In one embodiment, the suture is secured to the proximal end of the suture needle and is wrapped around the mandrel while the suture needle and suture are packaged inside the suture needle container. Wrapping the suture around the mandrel preferably facilitates easy removal and/or release of the suture from the suture needle receptacle.

In one embodiment, the suture needle container has an access opening at its proximal end that is sealed by the cover to maintain sterility of the suture needle and suture packaged into the suture needle container.

In one embodiment, the suture needle container may be part of a robotic system whereby a suture needle may be automatically loaded onto an end of a tool (e.g., a needle driver) and the loaded suture needle is advanced through a trocar by the system for placement of the suture needle at a surgical site.

In one embodiment, systems, devices and methods are provided for use in robotic surgery, and in particular for communicating with and controlling a robotic tool including an end effector.

In one aspect, there is provided a surgical robotic system comprising: a mechatronic arm configured to move on a plurality of axes; and a suture needle securing tool, such as a needle driver, having a clamping assembly configured to be coupled to the electromechanical arm. In one embodiment, the robotic system preferably includes a controller configured to control movement of the electromechanical arm and to control actuation of the gripping assembly of the suture needle securing tool. The electromechanical tool may include at least one visual indicator that indicates an effective length scale to allow for visual measurement of the motion of the end effector. The controller is configured to modify a motion of the end effector based on the visually measured motion.

In one embodiment, the robotic system may include a controller that transmits instructions to the electromechanical tool that are input by a surgeon or medical personnel to move the tool. The system may have a preset motion control threshold, and the controller may be configured to prevent the electromechanical tool from exceeding the preset motion control threshold while the controller moves the tool.

As used herein, the terms surgical needle and suture needle are used interchangeably. The surgical needle may or may not have a suture attached thereto. The suture needle may or may not have a suture attached thereto. Regardless of whether the term surgical needle or suture needle is used herein, the term may be used to describe needles having sutures attached thereto and needles not having sutures attached thereto.

These and other preferred embodiments of the present invention will be described in more detail below.

Drawings

FIG. 1A is a side view of a suturing needle having a proximal end and a distal end with a tapered section and a distal tip according to one embodiment of the present patent application.

FIG. 1B is an enlarged view of the tapered section and distal tip of the suture needle shown in FIG. 1A.

Fig. 2A is a perspective view of a needle driver having an elongate shaft with a proximal end, a distal end, and a clamping assembly located at the distal end of the elongate shaft, the clamping assembly including a lower jaw and an upper jaw movable between an open position and a closed position according to one embodiment of the present patent application.

Fig. 2B is a perspective view of the distal end of the elongate shaft and the clamping assembly of the needle driver shown in fig. 2A.

FIG. 3A illustrates a top plan view of the distal end of a needle driver having a clamp assembly with a lower jaw and an upper jaw for securing a suture needle according to one embodiment of the present patent application.

FIG. 3B shows the distal end of the needle driver shown in FIG. 3A with an upper jaw remover.

Fig. 3C shows a perspective end view of the distal end of the needle driver shown in fig. 3A-3B.

Fig. 3D shows another perspective end view of the needle driver shown in fig. 3A-3C.

FIG. 4A shows a perspective view of the proximal end of a suture needle container having a mandrel for aligning a needle driver with the tip of a suture needle according to one embodiment of the present patent application.

FIG. 4B shows another perspective view of the proximal end of the suture needle container shown in FIG. 4A.

FIG. 4C illustrates a proximal end view of the suture needle container shown in FIGS. 4A and 4B.

FIG. 4D illustrates another perspective view of the proximal end of the suture needle container illustrated in FIGS. 4A-4C.

FIG. 4E illustrates another perspective view of the proximal end of the suture needle container illustrated in FIGS. 4A-4D.

FIG. 5A shows a perspective view of a cross-section of the suture needle receptacle shown in FIGS. 4A-4E.

FIG. 5B shows a side view of a cross-section of the suture needle container shown in FIGS. 4A-4E and 5A.

FIG. 6A shows a perspective view of a suture needle container having a cover and loaded with a suture needle and suture wound around a mandrel according to one embodiment of the present patent application.

FIG. 6B shows a top perspective view of the suture needle container shown in FIG. 6A.

FIG. 7 illustrates a first step of a method of removing a suture needle from a suture needle container according to an embodiment of the present patent application.

FIG. 8 illustrates a second step of a method of removing a suture needle from a suture needle container according to an embodiment of the present patent application.

FIG. 9 illustrates a third step of a method of removing a suture needle from a suture needle container according to one embodiment of the present patent application.

FIG. 10 illustrates a fourth step of the method of removing a suture needle from a suture needle container according to one embodiment of the present patent application.

FIG. 11A shows a cross-sectional side view of a mandrel having a needle driver guide slot for aligning a clamping assembly with a suture needle according to one embodiment of the present patent application.

FIG. 11B shows a cross-sectional top view of the mandrel shown in FIG. 11A.

Fig. 12A shows a cross-sectional side view of the mandrel of fig. 11A and a needle driver inserted into a needle driver guide slot according to one embodiment of the present patent application.

FIG. 12B shows a cross-sectional top view of the mandrel and needle driver shown in FIG. 12A.

FIG. 13A shows a cross-sectional side view of the mandrel of FIG. 11A with the clamping assembly of the needle driver aligned with the tip of the suture needle according to one embodiment of the present patent application.

FIG. 13B shows a cross-sectional top view of the mandrel and needle driver shown in FIG. 13A.

Fig. 14A illustrates a stage in a method of advancing a resilient suture needle toward a distal end of a trocar using a needle driver according to an embodiment of the present patent application.

Fig. 14B shows the needle driver and resilient suture needle of fig. 14A after the suture needle has been advanced beyond the distal end of the trocar for positioning at a surgical site according to one embodiment of the present patent application.

Fig. 14C illustrates a stage in a method of retracting a resilient suture needle from a surgical site and toward a proximal end of a trocar using a needle driver according to an embodiment of the present patent application.

Fig. 14D illustrates a later stage of a method of retracting a resilient suture needle toward a proximal end of a trocar according to one embodiment of the present patent application.

FIG. 15 illustrates a first step of a method of securing a suture needle to a clamp assembly at a distal end of a needle driver according to an embodiment of the present patent application.

FIG. 16 illustrates a second step of the method of securing a suture needle to a clamp assembly at a distal end of a needle driver according to an embodiment of the present patent application.

FIG. 17 illustrates a front view of a rack containing a plurality of suture needle containers according to one embodiment of the present patent application.

FIG. 18 illustrates a front view of a rack containing a plurality of suture needle containers according to one embodiment of the present patent application.

FIG. 19 illustrates a robotic system for removing a suture needle from a suture needle container and passing the suture needle through a trocar according to one embodiment of the present patent application.

Detailed Description

Referring to fig. 1A and 1B, in one embodiment, the suture needle 100 preferably includes an elongated body 102 having an outer surface 104 extending from a proximal end 106 to a distal end 108 of the suture needle. In one embodiment, the proximal end 106 desirably includes a tube 110 having a suture attachment opening at the proximal end face of the suture needle adapted to receive one end of a suture for attaching the suture to the proximal end of the suture needle 100. The distal section of the suture needle 100 preferably includes a tapered section 112 that tapers inwardly to a distal tip 114 (e.g., a sharp tip) desirably located at the distal-most end of the suture needle 100. In one embodiment, the suture needle 100 is preferably made of an elastic, highly elastic or superelastic material, such as nitinol, which enables the suture needle to flex from a first shape (e.g., a semi-circle) to a second shape (e.g., a shape that is flatter than the semi-circle) in order to pass the suture needle through a trocar (e.g., a 5mm trocar). After the suture needle has been passed through the trocar, the elastic, highly elastic or superelastic suture needle (hereinafter collectively referred to as "suture needle") will desirably return to the original semicircular shape shown in fig. 1A and 1B. In one embodiment, the elastic suture needle 100 has a semicircular shape. In one embodiment, the elastic suture needles cover 3/8 circles, 1/2 circles, 5/8 circles, 3/4 circles, and the like.

In one embodiment, the suture needle 100 may have a bendable region or may be highly elastic for changing shape and/or configuration to fit through a trocar (e.g., a 5mm trocar), as disclosed in commonly assigned U.S. patent application serial No. ________ (ETH6024USNP1, ETH6035USNP1, and ETH6026USPSP), the disclosures of which are incorporated herein by reference.

Referring to fig. 2A and 2B, in one embodiment, the needle driver 116 may be utilized to secure the suture needle 100 shown and described above in fig. 1A-1B. In one embodiment, the suture needle is preferably releasably secured within the suture needle container for removal from the container by the needle driver. In one embodiment, the needle driver 116 preferably includes an elongate shaft 118 having a proximal end 120 and a distal end 122, wherein a gripping assembly 124 is provided at the distal end 122 of the elongate shaft 118. In one embodiment, the clamping assembly preferably includes a lower jaw 126 and an upper jaw 128 opposite the lower jaw. The clamp assembly 124 is preferably movable between an open position for receiving an object between the jaws and a closed position for clamping onto an object positioned between the jaws. In the closed position, the clamp assembly preferably secures an element, such as a suture needle, between the opposing lower and upper jaws 126, 128.

Referring to fig. 2B, in one embodiment, the lower jaw 126 preferably has a top surface 130 opposite a bottom surface 132 of the upper jaw 128. In one embodiment, the top and bottom surfaces 130, 132 of the respective lower and upper jaws 126, 128 are preferably mirror images of each other. In one embodiment, one or more of the top and bottom surfaces 130 has a surface roughness, such as knurling, for grasping the suture needle between the jaws when the clamping assembly is in the closed position. In one embodiment, the lower jaw 126 has a transverse surface 134 that defines an outer perimeter of the top surface 130 of the lower jaw 126. Similarly, the upper jaw 128 has a lateral surface 136 that defines an outer perimeter of the bottom surface 132 of the upper jaw 128. In one embodiment, the lower jaw 126 can be rigidly secured to the distal end 122 of the elongate shaft 118. The upper jaw 128 is preferably pivotally secured to the distal end 122 of the elongate shaft 118 via a pivot 138 that couples the proximal end of the upper jaw 128 to the distal end 122 of the elongate shaft 118. In one embodiment, the pivot 138 desirably enables the upper jaw 128 to pivot relative to the lower jaw 126 for moving the clamp assembly 124 between the open and closed positions.

In one embodiment, the clamp assembly 124 defines a slot from the upper jaw 128 when the lower and upper jaws 126, 128 are in the open position (fig. 2B)A height H extending from the top to the bottom of the lower jaw 126₁。

Referring to FIG. 3A, in one embodiment, the elongate shaft 118 of the needle driver preferably has a defined distance W₁Of the outer diameter of (a).

Referring to fig. 3A and 3B, in one embodiment, a clamp assembly 124 at the distal end 122 of the elongate shaft 118 is adapted to secure a distal section of the suture needle 100. In one embodiment, the top and bottom surfaces of the respective lower and upper jaws 126, 128 preferably clamp onto the tapered section 112 of the suture needle, and the lower and upper jaws enclose the tip 114 of the suture needle such that the tip is not exposed outside the periphery of the top and bottom surfaces of the respective lower and upper jaws 126, 128.

In one embodiment, the elongate shaft 118 of the needle driver 116 is preferably along the longitudinal axis a₁And (4) extending. In one embodiment, the tapered section 112 of the suture needle 100 is preferably along the second axis A when the tapered section 112 of the suture needle 100 is secured between the lower and upper jaws 126, 128₂Extend, the second axis being parallel to the longitudinal axis A of the elongate shaft 118₁Defining an angle alpha smaller than 90 DEG₁. Relative to the longitudinal axis A of the needle driver 116₁At an angle alpha less than 90 DEG₁Positioning the tapered section 112 of the suture needle 100 enables the trailing end of the suture needle to extend proximally toward the proximal end of the needle driver, which reduces the amount of force required to pass the suture needle through the trocar.

Referring to FIG. 3B, in one embodiment, the top surface 130 of the lower jaw 126 preferably has a length L that defines the top surface₁A proximal end 131 and a distal end 133. In one embodiment, the top surface 130 of the lower jaw 126 is desirably configured to align with the tip 114 of the suture needle 100, wherein the tip is positioned between the proximal and distal ends of the top surface 130 and within the periphery of the top surface. With the tip 114 of the suture needle 100 aligned with the top surface 130 of the lower jaw 126, the tapered section 112 of the suture needle 100 preferably extends on a lateral side 135 of the lower jaw 126 with the trailing end of the suture needle extending proximally toward the proximal end of the elongate shaft 118 of the needle driver 116.

Referring to fig. 3C and 3D, in one embodiment, needle driver 116 is preferably advanced toward tip 114 of suture needle 100 such that tip 114 is positioned between top surface 130 of lower jaw 126 and bottom surface 132 of upper jaw 128. In one embodiment, tip 114 is desirably positioned within the periphery of top surface 130 of lower jaw 126 such that tip 114 is not exposed outside of the lower jaw.

Referring to fig. 3D, in one embodiment, when clamp assembly 124 is closed, top and bottom surfaces 130, 132 of respective lower and upper jaws 126, 128 preferably engage tapered section 112 of suture needle 100 such that when the lower and upper jaws are moved to the closed position, the lower and upper jaws do not contact, squeeze, compress and/or deform tip 114 of suture needle 100.

Referring to fig. 4A and 4B, in one embodiment, the suture needle container 140 contains a suture needle, such as the suture needle 100 shown and described above in fig. 1A-1B. In one embodiment, a needle driver, such as the needle driver 116 shown and described above in fig. 3A-3D, may be utilized to remove a suture needle from a suture needle container. In one embodiment, the suture needle container 140 preferably includes an outer wall 142 having an open proximal end 144 and a closed distal end 146. In one embodiment, the outer wall 142 has a cylindrical shape. In one embodiment, the suture needle container 140 preferably includes an opening 148 provided at the proximal end 144 of the outer wall 142 that enables a needle driver to pass therethrough to access a suture needle stored in the suture needle container. In one embodiment, the suture needle container 140 preferably includes an end wall 150 that closes the distal end 146 of the outer wall 142. The end wall 150 preferably defines a closed end of the suture needle container 140.

In one embodiment, the needle container 140 preferably includes a mandrel 152 located inside the outer wall 142. The mandrel 152 may be centrally located within the perimeter of the outer wall 142. In one embodiment, the mandrel 152 preferably extends from the opening 148 at the proximal end 144 of the outer wall 142 to the end wall 150 at the distal end 146 of the outer wall 142. In one embodiment, the mandrel 152 preferably has a needle driver guide slot 154 adapted to receive the distal end of the needle driver and guide the distal movement of the needle driver toward the end wall 150 of the suture needle container 140. The mandrel 152 desirably has a suture needle slot 156 adapted to hold a suture needle, such as an elastic suture needle, for loading the distal end of the needle driver onto the distal end of the needle driver when inserting the distal end into the needle driver guide slot 154.

Referring to fig. 4C, in one embodiment, the mandrel 152 preferably includes a floor 158 defining a lower end of the needle driver channel 154. In one embodiment, the base plate 158 may have a concave surface that closely matches the shape of the outer surface of the elongate shaft of the needle driver. In one embodiment, the underside of the elongate shaft of the needle driver can engage and slide over the concave floor 158 when the needle driver is inserted into the needle driver guide slot 154. In one embodiment, the spindle 152 preferably includes a top plate 160 defining an upper end of the needle driver channel 154. In one embodiment, the top plate 160 may have a flat surface opposite the recessed floor 158. In one embodiment, the spindle 152 may include first and second lateral sidewalls 162A, 162B extending between the bottom plate 158 and the top plate 160 for defining the sides of the needle driver guide slot 154.

In one embodiment, needle driver channel 154 preferably has a height H extending from bottom plate 158 to top plate 160₂And a width W extending between the first and second lateral sidewalls 162A, 162B measured at a location between the needle slot 156 and the bottom panel 158₂. In one embodiment, the height H of the needle driver guide channel 154 is when the lower and upper jaws 126, 128 of the clamp assembly are in the open position (fig. 2B)₂Preferably the height H of the clamping assembly 124₁And (6) matching. In one embodiment, the width W of the needle driver channel 154₂(i.e., at a location between the suture needle slot and the recessed floor) preferably corresponds to an outer diameter or width W of the elongate shaft 118 of the needle driver 116₁(fig. 3A) to guide and control distal movement of the needle driver through needle driver guide slot 154.

In one embodiment, the suture needle slot 156 provided in the spindle 152 is spaced above the recessed floor 158 of the spindle 152 by a distance H₃The distance being greater than the outer diameter or width W of the elongate shaft 118 of the needle driver 116₁1/2, which ensures that the top surface of the lower jaw is positioned between the suture needle slot 156 and the floor 158 of the mandrel 152 when the distal end of the needle driver is inserted into the needle driver guide channel.

Thus, when the clamp assembly at the distal end of the needle driver is inserted into the needle driver guide channel 154 of the mandrel 152, the lower jaw of the needle driver is located below the suture needle slot 156 such that the top surface of the lower jaw is positioned below the tip of the suture needle, and the upper jaw of the needle driver is located above the suture needle slot 156 such that the bottom surface of the upper jaw is positioned above the tip of the suture needle.

Referring to fig. 4D and 4E, in one embodiment, the suture needle slot 156 of the suture needle container 140 preferably has a distal end 164 spaced from the end wall 150 at the closed distal end of the suture needle container 140. When the suture needle is positioned in the suture needle slot 156, the distal end 164 of the suture needle slot 156 preferably acts as a barrier such that the suture needle is spaced from the end wall 150 of the suture needle container 140. When a needle driver is inserted into the needle driver guide channel 154 for loading a suture needle onto the needle driver, the spacing of the distal end 164 of the suture needle slot 156 from the end wall 150 of the suture needle container 140 desirably achieves consistent, reliable and repeatable alignment of the top and bottom surfaces of the respective lower and upper jaws of the clamping assembly with the top end of a suture needle held within the suture needle slot 156 of the suture needle container 140.

Referring to fig. 5A and 5B, in one embodiment, the mandrel 152 desirably has a proximal end 155 that aligns with the proximal end 144 of the outer wall 142 of the suture needle container 140. The suture needle slot 156 is preferably open at the proximal end 155 of the mandrel 152. Suture needle slot 160 has a closed distal end 164 (acting as a stop) spaced from end wall 150 by a length L less than top surface 130 of lower jaw 126₁(FIG. 3B) distance L₂. In one embodimentIn this regard, the suture needle may be pre-positioned within the suture needle slot 156 by: the suture needle is inserted into the open end of the suture needle slot and advanced distally through the suture needle slot 156 until the body of the suture needle abuts the distal end 164 of the suture needle slot 156.

In one embodiment, when the clamp assembly at the distal end of the needle driver is inserted into the open end of the needle driver guide channel 154, the needle driver can be advanced in direction DIR1 until the distal ends of the lower and upper jaws abut the end wall 150 of the suture needle container 140. In one embodiment, at that stage of distal advancement, the leading end of the lower jaw will abut end wall 150, which will then align the tip of the suture needle with the opposing top and bottom surfaces of the respective lower and upper clamping jaws.

Referring to fig. 6A and 6B, in one embodiment, the suture needle container 140 preferably has an outer wall 142 extending from a proximal end 144 to a distal end 146. The suture needle container 140 preferably has an opening 148 at the proximal end 144 of the outer wall 142 and an end wall 150 forming a closed distal end of the suture needle container 140. In one embodiment, the open end 148 of the suture needle receptacle 140 is preferably covered by a cover 174 that can seal the open end 148 of the suture needle receptacle 140. The cover 174 may maintain a sterile environment inside the suture needle container 140 such that the suture needle and suture remain sterile during shipment and storage of the suture needle container. In one embodiment, the cover 174 may be made of foil, polymeric materials, breathable materials such as high density polyethylene (e.g., Tyvek), and any other well-known materials that may be used to maintain the sterile environment of medical devices and tools.

Referring to FIG. 6B, in one embodiment, to position the suture needle inside the suture needle container, it is preferred that the tip 114 (FIG. 1A) at the distal most end of the tapered section 112 of the suture needle 100 is inserted into the suture needle slot 156 of the mandrel 152 such that the tip is inside the needle driver guide slot 154 and the rear section of the suture needle is between the mandrel 152 and the outer wall 142 of the suture needle container 140. The tip of the needle 100 is advanced toward the end wall 150 of the needle receptacle 140 until the tapered section 112 of the needle abuts the terminal end 164 (FIG. 5B) of the needle slot 156. In one embodiment, the suture needle 100 preferably has a surgical suture 176 attached to a suture attachment opening at the proximal end 106 of the suture needle 100. Suture 176 may be wrapped around mandrel 152 for storage inside needle container 140 between the outer surface of the mandrel and the inner surface of outer wall 142.

Referring to fig. 7, in one embodiment, to remove the suture needle 100 from the suture needle container 140, the cover 174 is preferably removed (e.g., pierced, peeled, cut, etc.) to access the opening 148 at the proximal end of the outer wall 142 of the suture needle container 140. Once the cover 174 has been removed or opened, the distal end of the needle driver 116 can be inserted into the needle driver guide slot 154 of the mandrel 154 with the lower jaw 126 of the clamp assembly 124 positioned adjacent to the recessed floor 158 (fig. 4C) at the lower end of the needle driver guide slot 154 and the upper jaw 128 (in the open position) extending to the top plate 160 at the upper end of the needle driver guide slot. In one embodiment, the lower and upper jaws define a height H that is approximately the needle driver guide slot 154 when the clamp assembly 126 is in the open position₂Height H of₁(FIG. 2B) to guide and control the orientation of the needle driver 116 as the clamp assembly 124 is advanced toward the end wall 150 at the distal end of the outer wall 142 of the suture needle container 140.

Referring to FIG. 8, in one embodiment, the tapered section 112 of the suture needle 100 is located at the terminal end 164 of the suture needle slot 156. In one embodiment, the clamp assembly 124 at the distal end of the needle driver 116 is advanced through the needle driver guide slot 154 and toward the end wall 150 of the suture needle container 140 until the distal end of the lower jaw engages the end wall 150. In this position, the opposing top and bottom surfaces of the respective lower and upper jaws 126, 128 of the clamp assembly 124 are preferably aligned with the top end of the suture needle 100 located inside the needle driver guide channel 154.

Referring to FIG. 9, in one embodiment, after the opposing faces of the respective lower and upper clamping jaws have been aligned with the distal tip of the suture needle 100, the clamping assembly is preferably moved to the closed position such that the opposing faces of the lower and upper clamping jaws engage the tapered section of the suture needle 100 proximal of the distal tip of the suture needle. With the clamp assembly in the closed position for securing the suture needle 100, the elongate shaft 118 of the needle driver 116 can be withdrawn from the needle driver guide slot 154 for removal of the suture needle 100 from the proximal open end of the suture needle slot 156 of the mandrel 152. In one embodiment, as the suture needle 100 is extracted from the suture needle container 140, the tapered section 112 of the suture needle 100 slides through the suture needle slot 156 toward the proximal open end of the suture needle slot.

FIG. 10 shows the suture needle 100 during further extraction from the suture needle container 140. The tapered section 112 of the suturing needle 100 is secured by a clamping assembly 124 of the needle driver 116. The tapered section 112 is removed from the open end of the suture needle slot 156 at the proximal end 155 of the mandrel 152.

FIGS. 11A-11B, 12A-12B, and 13A-13B illustrate a system and method for removing a suture needle from a suture needle container using a needle driver according to one embodiment of the present patent application. The system and method may be incorporated into a robot such that the steps are performed using computer software, hardware, processors, and robotics.

Referring to fig. 11A and 11B, in one embodiment, the mandrel 152 of the suture needle container 140 preferably includes a floor 158, a ceiling 160, and first and second transverse guide walls 162A, 162B defining a needle driver guide slot 152 extending from the proximal end 155 of the mandrel to the distal end wall 150 of the needle driver container. The mandrel 152 includes a suture needle slot 156 adapted to hold a suture needle, the suture needle slot having an open end at the proximal end 155 of the mandrel 152 and being proximally spaced from the end wall 150 by a distance L₂And a terminal 164. The suture needle slot 156 retains the tip 114 and a portion of the tapered section 112 of the suture needle inside the needle driver guide slot 154 of the mandrel 152 such that the lower and upper jaws of the gripping assembly of the needle driver can be advanced into alignment with the tip 114 and the portion of the tapered section.

Referring to fig. 12A and 12B, in one embodiment,the clamp assembly 124 of the needle driver 116 is inserted into the proximal end 155 of the mandrel 152 with the lower jaw 126 and the upper jaw 128 (fig. 12A) in the open position. The lower jaw 126 is positioned above the bottom plate 158 of the mandrel 152 and the upper jaw 128 is positioned adjacent to the top plate 160 of the mandrel. The lower and upper jaws 126, 128 define a height H relative to the needle driver guide slots 154 extending from the bottom plate 158 to the top plate 160₂Matched height H₁. The elongate shaft 118 of the needle driver 116 has a width W corresponding to the needle driver guide slot 154₂Matched width W₁. Thus, the needle driver guide slot 154 preferably has a shape and configuration that closely conforms to the shape of the distal end of the needle driver 116 for controlling the orientation and advancement of the needle driver 116 as it moves through the needle driver guide slot 154 in the distal direction DIR 1.

In one embodiment, the spindle 152 preferably includes a base 158 having a spacing H above the spindle 152₃A lower end of the needle slot 156. In one embodiment, distance H₃Greater than 1/2 of the outer diameter of the elongate shaft 118 of the needle driver 116. Thus, when lower jaw 126 is inserted into needle driver guide channel 154 for sliding past floor 158 of needle driver guide channel 154, top surface 130 of lower jaw 126 will be located between suture needle slot 156 of the mandrel and floor 158, thereby ensuring that top surface 130 of lower jaw 126 will be positioned below tip 114 of suture needle 100.

Referring to fig. 13A and 13B, in one embodiment, needle driver 116 is advanced distally in needle driver guide slot 154 until distal end 175 of lower jaw 126 abuts end wall 150 of the suture needle container. The terminal end 164 of the needle slot 156 holds the tip 114 of the needle 100 a distance L from the end wall 150₂To (3). Top surface 130 of lower jaw 126 has a distance L that is greater than the distance between the tip 114 of the suture needle and end wall 150₂Length L of₁. Thus, when distal end 175 of lower jaw 126 abuts end wall 150 of the suture needle container, top surface 130 of lower jaw 126 is aligned with tip 114. In one embodiment, the tip is preferably positioned near a midpoint along the length of the top surface of the lower jaw. In addition, with the top surface 13 of the lower jaw 126The bottom surface 132 of the upper jaw 128, which is a mirror image of 0, is also aligned with the top end 114. Because suture needle slot 156 is positioned above top surface 130 of lower jaw 126, tip 114 of the suture needle is desirably positioned between the gripping faces of lower and upper jaws 126, 128.

When the clamp assembly 124 of the needle driver 116 is moved to the closed position to secure the suture needle 100 between the lower and upper jaws 126, 128, the top and bottom surfaces 130, 132 of the respective lower and upper jaws preferably engage the tapered section 112 of the suture needle 100 located between the jaws. In one embodiment, the lower and upper jaws 126, 128 preferably clamp onto the tapered section 112 of the suture needle 100 and are spaced from the tip 114 of the suture needle, as engaging the tip with the top and bottom clamping surfaces can damage, destroy, blunt, bend, and/or deform the tip of the suture needle, making it unsuitable for its intended purpose (e.g., a suturing operation). In one embodiment, when clamp assembly 124 is in the closed position for securing a suture needle, top and bottom clamping surfaces 130, 132 of respective lower and upper jaws 126, 128 preferably completely enclose tip 114 of suture needle 100 such that the tip is protected by needle driver 116 as it pushes or pulls the loaded suture needle through the trocar.

Referring to fig. 14A, in one embodiment, after the elastic, highly elastic or superelastic suture needle 100 has been loaded onto the needle driver 116, the needle driver 116 can be utilized to advance the suture needle 100 through the trocar 180 for positioning the suture needle at a surgical site. In one embodiment, the trocar 180 preferably has an elongated tube 182 defining an inner diameter that extends to an opening at a distal end 184 of the trocar. The clamping assembly 124 of the needle driver 116 is preferably advanced through the tubing 182 of the trocar 180 for pulling the suture needle 100 therethrough. The elongate body 102 of the superelastic needle 100 preferably elastically deforms (e.g., tears, flattens, assuming a low profile) as the clamp assembly 124 pulls the needle 100 toward the distal end 184 of the trocar 180.

Referring to fig. 14B, after the gripped suture needle 100 has advanced beyond the distal end 184 of the trocar 180, the suture needle 100 having elastic properties preferably returns to an original curved configuration (e.g., a semicircular shape). The surgical personnel may then perform a suturing operation at the surgical site using the curved suture needle 100.

Referring to FIG. 14C, in one embodiment, at the conclusion of the suturing operation, the suture needle 100 may be removed from the patient by retracting the suture needle through the trocar 180. In one embodiment, the clamp assembly 124 is again closed for securing the distal end of the curved suture needle 100 between the lower jaw 126 and the upper jaw 128 of the needle driver 116.

Referring to FIG. 14D, in one embodiment, the suture needle 100 can be withdrawn through the cannula 182 of the trocar 180. Suture needle 100, which is resilient in nature, preferably tears flat as it is withdrawn through the trocar by a clamping assembly 124 of needle driver 116. Lower and upper jaws 126, 128 preferably engage a tapered section of suture needle 100 as the needle is withdrawn through trocar 180 and protect the tip from contacting the interior of the trocar.

In one embodiment, the suture needle may be loaded onto the needle drive using an automated system or a robotic system. The suture needle may be enclosed inside a different suture needle container (e.g., a pot receptacle) or envelope that maintains the suture needle and attached suture in a sterile environment prior to use during a surgical procedure. The suture needle containers may be stored on a shelf or in a matrix, with each container having a unique identification number or code assigned thereto.

Referring to FIG. 15, in one embodiment, the suture needle container 240 preferably has an outer wall 242 extending from a proximal end 244 to a distal end 246 thereof. The proximal end 244 is preferably covered by a cover 274 that maintains a sterile environment for the one or more suture needles and one or more sutures stored inside the container. In one embodiment, the distal end of the needle driver 116 may pierce the cover 274 for removal of the suture needle and suture (not shown) preloaded inside the suture needle container 240. The needle container 240 preferably includes an end wall 250 that forms the closed end of the container. The suture needle container 240 desirably includes a mandrel 252 having a needle driver guide channel 254 and a suture needle slot 256 that can be used to retain the suture needle 200 inside the suture needle container 240.

In one embodiment, the sealed cover 274 provides a sterile environment inside the suture needle container 240. Thus, a suture needle that is pre-positioned inside the suture needle container 240 may be stored in a sterile environment until it is desired that the suture needle be used during a surgical procedure.

Referring to fig. 16, in one embodiment, the distal end of the needle driver 116 can be advanced toward the end wall 250 for piercing the cover 274 to provide access to the suture needle 200 and suture stored within the suture needle container 240. After the distal end of the needle driver 116 pierces the cover 274, the clamp assembly 224 at the distal end of the needle driver 116 may be advanced into the needle guide channel 254 of the mandrel 252 for accessing the suture needle 200 pre-positioned at the closed end of the suture needle slot 256.

Referring to FIG. 17, in one embodiment, a plurality of suture needle containers 340A-340H having a structure similar to that disclosed herein may be pre-stored (e.g., stored on a rack or surgical table located in an operating room) for use during a surgical procedure. Each of the suture needle containers may contain a different type of suture needle such that the surgeon will be able to select a different type of suture needle for use during the surgical procedure. For example, a surgeon may want to suture delicate tissue using a first type of suture needle and an organ using a second type of suture needle.

In one embodiment, the suture needle container has a cylindrical shape (i.e., circular cross-section) with a removable cover covering the open end of the container. In one embodiment, each of the suture needle containers 340A-340H includes a unique identifier (e.g., a bar code, an electronic chip) that identifies a particular type of suture needle and/or a combination of suture needle and suture thread disposed within the container interior. In one embodiment, the first suture needle container 340A may comprise a stainless steel needle and an unbarbed suture attached to the proximal end of the stainless steel suture needle. The second suture needle container 340B may include a superelastic suture needle having a barbed suture attached to a proximal end thereof. Other combinations of needles and sutures (e.g., barbed, unbarbed, etc.) made of particular materials (e.g., stainless steel, Ethalloy, nitinol, etc.) may be included in other needle containers 340C-340H. Accordingly, medical personnel can select from a wide variety of different combinations of needles and sutures to perform various types of surgical procedures and suturing operations.

Referring to FIG. 18, in one embodiment, a plurality of suture needle containers 440A-440H may be pre-stored for use during a surgical procedure. In one embodiment, the suture needle container has a pyramid shape (e.g., a triangular cross-section) with a sealed cover covering the open end of the container for maintaining the sterile environment of the suture needle and suture loaded inside the container. The container may be oriented using its pyramidal shape to provide an intuitive way for medical personnel to determine the proper orientation of the container for use with the needle driver. In one embodiment, the suture needle container may have an asymmetric cross-section, which enables the container to be stored or aligned in only one possible orientation.

In one embodiment, the systems, devices, and methods disclosed herein may be combined with a robotic or computer-controlled system that enables a surgeon to automatically select a particular type of suture needle for use and have the robotic system use a computer-controlled actuator to access a suture needle container, use a surgical tool (e.g., a needle driver) to remove the selected suture needle from the suture needle container, and use the surgical tool to pass the selected suture needle through a trocar or catheter for delivery at a surgical site.

Referring to fig. 19, in one embodiment, the robotic system 500 preferably includes one or more processors 502 that can control the operation of the robotic system 500. A "processor" is also referred to herein as a "controller". Processor 502 may include any type of microprocessor or Central Processing Unit (CPU), including a programmable general purpose microprocessor or a special purpose microprocessor, and/or any of a variety of proprietary or commercially available single or multi-processor systems. The robotic system 500 may also include one or more memory devices 504 that may provide temporary storage for code to be executed by the processor 502 or data retrieved from one or more users, storage devices, and/or databases. Memory device 504 may include Read Only Memory (ROM), flash memory, one or more Random Access Memories (RAMs) (e.g., Static RAM (SRAM), Dynamic RAM (DRAM), or Synchronous DRAM (SDRAM)), and/or a combination of memory technologies.

Various elements of the robotic system 500 may be coupled to a bus system 508. The illustrated bus system 508 is an abstraction that represents any one or more separate physical buses, communication lines/interfaces, and/or multi-drop or point-to-point connections, connected by appropriate bridges, adapters, and/or controllers. The robotic system 500 may also include one or more network interfaces 510, one or more input/output (IO) interfaces 512, and one or more storage devices 514.

The network interface 512 preferably enables the robotic system 500 to communicate with remote devices (e.g., other computer systems) over a network, and may be, for non-limiting example, a remote desktop connection interface, an ethernet adapter, and/or other Local Area Network (LAN) adapter. The IO interface 512 may include one or more interface components to connect the robotic system 500 with other electronic equipment. For non-limiting examples, the IO interface 512 may include a high-speed data port, such as a Universal Serial Bus (USB) port, 1394 port, Wi-Fi, Bluetooth, or the like. Additionally, robotic system 500 may be accessible by a human user, and thus IO interface 512 may include a display, speakers, a keyboard, a pointing device, and/or various other video, audio, or alphanumeric interfaces. Storage 514 may include any conventional media for storing data in a non-volatile and/or non-transitory manner. Thus, the storage device 514 may maintain the data and/or instructions in a persistent state, i.e., retain values despite the interruption of power to the robotic system 500. The storage 514 may include one or more hard disk drives, flash drives, USB drives, optical drives, various media cards, floppy disks, compact disks, and/or any combination thereof, and may be connected directly to the robotic system 500 or remotely (such as over a network). In one embodiment, the storage device may include a tangible or non-transitory computer readable medium configured to store data, such as a hard disk drive, a flash memory drive, a USB drive, an optical disk drive, a media card, a floppy disk, a compact disk, and so forth.

The elements depicted in fig. 19 may be some or all of the elements of a single physical machine. In addition, not all illustrated elements may be required to be on or within the same physical machine. Exemplary robots and computer systems may include conventional desktop computers, workstations, minicomputers, laptop computers, tablet computers, Personal Digital Assistants (PDAs), mobile phones, and the like.

The robotic system 500 may include a web browser for: retrieving web pages or other markup language streams; presenting the pages and/or streams (visually, audibly, or otherwise); executing scripts, controls and other code on those pages/streams; accepting user input regarding those pages/streams (e.g., for the purpose of completing input fields); a hypertext transfer protocol (HTTP) request is issued (e.g., to submit information from completed input fields to the server) regarding those pages/streams or other aspects, and so forth. The web pages or other markup language may be hypertext markup language (HTML) or other conventional forms, including embedded extensible markup language (XML), scripts, controls, and the like. Computer system 500 may also include a web server for generating and/or delivering web pages to client computer systems.

In one embodiment, the robotic system 500 may be provided as a single unit, e.g., as a single server, as a single tower, housed within a single enclosure, etc. The individual units may be modular such that various aspects thereof may be swapped in and out as needed, for example, for upgrade, replacement, maintenance, etc., without disrupting the functionality of any other aspect of the system. Thus, a single unit may be scalable, which can be added as an additional module and/or where additional functionality of an existing module is desired and/or improved.

The robot or computer system may also include any of a variety of other software and/or hardware components, including, by way of non-limiting example, an operating system and a database management system. Although an exemplary robotic system is depicted and described herein, it will be appreciated that this is for generality and convenience. In other embodiments, the robotic system may differ in architecture and operation from the robotic systems shown and described herein.

The systems and devices disclosed herein may also be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the system and device may be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts and subsequent reassembly. In particular, the systems and devices may be disassembled, and any number of the particular pieces or parts of the systems and devices may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, the systems and devices may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a system or device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques, and the resulting reconditioned systems and devices, are all within the scope of the present application.

As described above, in one embodiment, the systems, devices, and methods disclosed herein may be used during robotic surgery, such as hernia repair surgery. In one embodiment, the patient is prepared for surgery by administering anesthesia. In one embodiment, abdominal access may be obtained by inserting two or more ports through the abdominal wall and insufflating the abdominal cavity. In one embodiment, the surgical robot is attached to a pre-placed port. A laparoscopic camera may be used to assess hernia sites under direct visualization. Adhesions were reduced and peritoneal sacs were excised as appropriate. The mesh is placed into the abdominal cavity. The surgeon selects from a plurality of suture implants to identify one that is appropriate for the type of hernia repair being performed. The categories may include different tissue anchors, the total number of tissue anchors on the suture implant, different suture loop lengths, different suture length, etc.

The robotic systems disclosed herein may be coupled with an inventory management system for documenting the type of suture needle used and generating reports and/or ordering replacement parts to replenish inventory. The robotic systems disclosed herein may be coupled with an invoicing system for charging an account (e.g., a patient's account) and generating invoices. The robotic system disclosed herein tracks the type of medical procedure performed and the type of suture needle selected for performing different types of medical procedures. The robotic system may provide computer-generated reports or alerts to the surgeon to "suggest" the type of suture needle typically used for a particular type of surgery to the surgeon and to inform the surgeon whether the suture needle that has been selected falls outside the range of suture needles typically selected for the particular surgery. For example, if the surgeon chooses to use one type of suture needle that is rarely or never used for a particular surgical procedure, the robotic system may generate a message to the surgeon to inform the surgeon of that fact. The robotic system may then recommend to the surgeon the type of suture needle that he/she may want to select. Thus, the robotic system may provide real-time guidance to the surgeon regarding the appropriate tools used for different types of surgical procedures.

Those skilled in the art will appreciate that electronic communication between the various components of the robotic surgical system may be wired or wireless. Those skilled in the art will also appreciate that all electronic communications in the system may be wired, all electronic communications in the system may be wireless, or portions of the system may communicate by wire and other portions of the system may communicate wirelessly.

In one embodiment, a delivery device (such as a needle driver) secures one of the suture needles from one of the suture needle containers. A distal end of the delivery device is advanced through one of the port openings for delivering the selected suture needle at the surgical site.

In one embodiment, the systems and delivery devices disclosed herein may be coupled to and/or in communication with a robotic surgical system, such as the systems and devices disclosed in U.S. patent No. 9,125,662 to Shelton, the disclosure of which is hereby incorporated by reference. In one embodiment, the robotic surgical system may have a sterile barrier between the applicator instrument and the surgical tool and the robotic portion of the robotic surgical system, whereby the system, the delivery device, the suture needle receptacle, the suture needle, and the suture are located in a sterile environment.

In one embodiment, the robotic surgical system may have a master controller and control system, such as the system and apparatus disclosed in U.S. patent No. 7,524,320, the disclosure of which is incorporated herein by reference. The master controller may have control elements (e.g., knobs, actuators) that are utilized by the surgeon and manipulated in space as the surgeon views the surgical site through a video monitor and/or stereoscopic display. The master controller may include a manual input device that moves in multiple degrees of freedom. In one embodiment, the master controller has an actuator for actuating a surgical tool (e.g., loading a surgical needle onto a needle driver).

In one embodiment, a robotic surgical system may include a robotic cart or rack configured to actuate a plurality of surgical tools and/or instruments. Various robotic surgical systems and methods employing master controllers and robotic cart arrangements are disclosed in U.S. patent No. 6,132,368, the disclosure of which is incorporated herein by reference. In one embodiment, the robotic cart or stand may include a base that supports a surgical tool. In one embodiment, the surgical tool may be supported by a series of manually articulatable links (commonly referred to as set-up joints) and robotic manipulators. These structures may have a protective cover that extends over a substantial portion of the robot links. The cover may be optional and may be limited in size or eliminated altogether to minimize the inertia encountered by the servo motor for operating such devices; limiting the volume of the moving parts to avoid collisions; and limiting the total weight of the robotic cart. In one embodiment, the robotic cart may have dimensions suitable for transporting the cart between operating rooms. The robotic cart is preferably configured to pass through a standard operating room door and be placed onto a standard hospital elevator. The robotic cart preferably has a weight and includes one or more wheels that allow the cart to be easily moved and positioned adjacent to the operating table.

Other embodiments may incorporate a wide variety of alternative robotic structures, including the robotic structure described in U.S. patent No. 5,878,193, the disclosure of which is hereby incorporated by reference. Additionally, while data communication between the robotic component and the processor of the robotic surgical system has been described with reference to communication between the surgical tool and the master controller, similar communication may occur between circuitry of the manipulator, mounting joints, endoscope or other image capture device, etc. and the processor of the robotic surgical system to enable component compatibility verification, component type identification, component calibration communication, and verification of coupling of the component to the robotic surgical system.

In one embodiment, during a surgical procedure, a surgeon may input control commands to a master controller or control unit of a robotic surgical system that "robotically generates" output motions that are ultimately transmitted to the systems, needle drivers, suture needle containers, and/or delivery devices disclosed herein. As used herein, the term "robotically generated" or "robotically generated" refers to motion produced by powering and controlling motors and other electrically driven components of a robotic surgical system. These terms are distinguishable from the terms "manually actuatable" or "manually generated," the latter referring to actions taken by the surgeon that result in control motions that are generated independently of those motions generated by powering the motors of the robotic surgical system.

Versions of the above-described apparatus are applicable to both conventional medical treatments and procedures performed by medical professionals as well as robotically-assisted medical treatments and procedures. For example, the various teachings herein can be readily incorporated into robotic Surgical systems, such as davinc (integrated Surgical, inc., of Sunnyvale, Calif), of integrated Surgical corporation, senerville, california^TMProvided is a system.

The versions described above may be designed to be discarded after a single use, or they may be designed to be used multiple times. In either or both cases, these versions may be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. After cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting reconditioned device are all within the scope of the present application.

In one embodiment, the systems and devices disclosed herein can be sterilized before and/or after a surgical procedure. In one sterilization technique, the suture needle and attached suture are placed inside a suture needle container that is closed and/or sealed by a cover. The cover may be made of various materials for obtaining and maintaining a sterile environment within the sealed container, such as a foil cover, a plastic cover, a polymer cover, high density polyethylene, and/or a cover made of TYVEK sheet. The sealed container may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the needle receptacle, needle, suture and seal cover. The sterilized containers may then be stored in sterile containers for later use. The sealed container may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow. For example, the present invention contemplates that any feature shown in any embodiment described herein or incorporated by reference herein can be incorporated with any feature shown in any other embodiment described herein or incorporated by reference herein and still fall within the scope of the present invention.