Patent Application
20220287715
The present disclosure relates to surgical stapling apparatus and, more particularly, to surgical stapling apparatus and methods for inspecting staple formation and hemostasis in anastomosis procedures.
Fasteners have traditionally been used to replace suturing when joining various body structures such as, for example, the bowel or bronchus. Surgical stapling apparatus employed to apply these fasteners are generally designed to simultaneously cut and seal tissue to reduce the time and risks involved with anastomosis procedures.
Circular surgical stapling apparatus are employed by surgeons to apply one or more surgical fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of anastomoses. Circular surgical stapling apparatus generally include an annular fastener cartridge assembly that supports a plurality of annular rows of fasteners, an annular anvil assembly operatively associated with the fastener cartridge assembly which provides a surface against which the fasteners are formed upon a firing of the circular stapling apparatus, and an annular blade for cutting tissue. One challenge in effectuating anastomoses is ensuring proper staple formation and hemostasis without having direct visualization of the surgical site.
According to one aspect, this disclosure is directed to a surgical stapling apparatus. The surgical stapling apparatus includes a cartridge assembly, an anvil assembly, and a camera assembly. The cartridge assembly supports an array of fasteners therein. The anvil assembly is movably positioned relative to the cartridge assembly between an unclamped position and a clamped position for forming the array of fasteners. The camera assembly is coupled to the anvil assembly and positioned to collect and transmit image data of a fastened tissue site.
In aspects, the camera assembly may be coupled to the anvil assembly via a tether.
In aspects, the camera assembly may include a camera member having at least one camera. The at least one camera may include a proximal camera supported on a proximal end portion of the camera member and a distal camera supported on a distal end portion of the camera member. Each of the proximal and distal cameras may be configured to provide a 360-degree view and wirelessly transmit image data of the 360-degree view.
In aspects, the camera member may be wireless and supported in a housing assembly. The housing assembly may include a first portion and a second portion that are removably coupled to one another. The first and second portions of the housing assembly may be threadedly coupled together.
In aspects, the tether may be coupled to the anvil assembly by a ball joint. The tether may be coupled to a proximal end portion of the second portion of the housing assembly to maintain the camera member a predetermined distance away from a distal end portion of the anvil assembly.
According to yet another aspect, this disclosure is directed to an end effector of a circular stapling apparatus. The end effector includes a cartridge assembly, an anvil assembly having an anvil head, and a camera assembly connected to the anvil head of the anvil assembly via a tether. The camera assembly is spaced-apart from the anvil assembly and positioned to collect and transmit image data of a fastened tissue site.
In aspects, the camera assembly may include a camera member having at least two cameras. The at least two cameras may include a proximal camera supported on a proximal end portion of the camera member and a distal camera supported on a distal end portion of the camera member. Each of the at least two cameras may be configured to provide a 360-degree view and wirelessly transmit image data of the 360-degree view.
In aspects, the camera member may be wireless.
In aspects, the camera member may be supported in a housing assembly.
In aspects, the housing assembly may include a first portion and a second portion that are removably coupled to one another.
In aspects, a proximal end portion of the tether may be coupled to the anvil assembly by a ball joint.
In aspects, a distal end portion of the tether may be coupled to the camera member to maintain the camera member a predetermined distance away from a distal end portion of the anvil assembly.
According to yet another aspect, a circular stapling apparatus is provided. The circular stapling apparatus includes a surgical instrument, an elongated body extending from the surgical instrument, and an end effector supported on a distal end portion of the elongated body. The end effector includes a cartridge assembly, an anvil assembly, and a camera assembly connected to the anvil assembly via a tether.
Other aspects, features, and advantages will be apparent from the description, the drawings, and the claims that follow.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate aspects of the disclosure and, together with a general description of the disclosure given above and the detailed description given below, explain the principles of the disclosure, wherein:
Aspects of the disclosed surgical stapling apparatus are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As commonly known, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Additionally, the term “proximal” refers to the portion of structure that is closer to the clinician and the term “distal” refers to the portion of structure that is farther from the clinician.
In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
In general, this disclosure describes a circular surgical stapling apparatus including a camera assembly tethered to an anvil assembly thereof for facilitating inspection of staple formation, hemostasis, and profusion integrity. The camera assembly can be inserted extracorporeally into a tissue lumen (e.g., an intestine, colon) simultaneously with the anvil assembly. The tissue lumen can be purse string closed around the anvil assembly so that an anastomosis can be effectuated with the end effector of the circular surgical stapling apparatus. The tether is configured to position the camera assembly a predetermined distance away from the anvil assembly to facilitate proper viewing of an anastomosis site. Once the anastomosis is complete, the anvil assembly can be moved relative to the anastomosis site (e.g., retracted therethrough) and the camera assembly can be used to wirelessly transmit image data of the exposed fastener line in the anastomosis site. Optical tissue evaluation can also be performed with such image data to determine a level of profusion and provide the clinician with an additional indication of tissue health. Advantageously, the disclosed stapling apparatus is configured to ensure a hemostatic anastomosis with good profusion that is critical to promote healing and prevent leakage of luminal contents into a patient's abdomen, and which also helps to prevent sepsis. Indeed, this disclosure provides a surgical stapling apparatus with an integrated camera assembly that enables a clinician to inspect both sides of an anastomosis without the need to insert an additional endoscope.
With reference to
End effector 300 generally includes a shell or cartridge assembly 310 and an anvil assembly 320 that are positionable between an unclamped position (see
Briefly, cartridge assembly 310 of end effector 300 includes a shell 312 and a staple cartridge 314 that supports fasteners “F” (e.g., staples; see
Reference may be made to U.S. Pat. No. 8,806,973 to Ross et al. and U.S. Pat. No. 7,303,106 to Milliman et al., the entire contents of each of which are incorporated herein by reference, for a detailed description of the construction and operation of an example electromechanical surgical stapling apparatus, the components of which are included, combinable and/or interchangeable with one or more components of surgical stapling apparatus 10 described herein.
Although surgical stapling apparatus 10 is described as an electromechanically powered surgical stapling apparatus, the disclosed surgical stapling apparatus 10 can be provided as a manually powered stapling apparatus. For a more detailed description of the construction and operation of an exemplary manually powered stapling apparatus, one or more components of which can be included, combined and/or interchanged with the electromechanically powered stapling apparatus described herein, reference can be made to U.S. Pat. No. 5,915,616 to Viola et al., U.S. Pat. No. 8,109,426 to Milliman et al., and U.S. Pat. No. 8,272,552 to Holsten et al., U.S. Pat. No. 9,504,470 to Milliman, the entire contents of which are incorporated by reference herein.
Referring now to
Housing assembly 334 of camera assembly 330 includes a proximal housing 334a and a distal housing 334b that are threadedly coupled together to enable proximal and distal housings 334a, 334b to be selectively separated from one another for accessing camera member 332. Although shown as threadedly coupled together, proximal and distal housings 334a, 334b can be secured together using any suitable mechanical interface (e.g., friction fit, magnetics, adhesive, etc.). Further, although housing assembly 334 is shown with an oblong, egg-shaped configuration, housing assembly 334 can have any suitable geometry. In some aspects, proximal and distal housings 334a, 334b may be integrally (e.g., monolithically) formed. In aspects, one or both proximal and distal housings 334a, 334b may include transparent material to facilitate imaging of adjacent tissue “T” (e.g., anastomosed tissue “AT”; see
Turning now to
Anvil assembly 320 of end effector 300 can then be separated from cartridge assembly 310 of end effector 300 to release the fastened and now anastomosed tissue “AT.” With camera 332 disposed distal to the anastomosed tissue “AT,” proximal camera 332a can be utilized to generate image data of the distal portion of the anastomosed tissue “AT.” Such image data (e.g., photos, videos, etc.) can be electrically communicated (e.g., wirelessly) to a display (not shown, but which may be on a handle of surgical stapling apparatus 10 and/or coupled to a remote workstation) so that a clinician can inspect a distal portion of the staple formation and hemostasis of the anastomosed tissue “AT.” End effector 300 can be retracted proximally to a position in which camera member 332 of camera assembly 330 is proximal to the anastomosed tissue “AT” so that distal camera 332a of camera member 332 can be utilized to generate image data of the proximal portion of the anastomosed tissue “AT.” Again, such image data can be electrically communicated (e.g., wirelessly) to the display so that a clinician can inspect the proximal portion of the staple formation and hemostasis of the anastomosed tissue “AT.”
As seen in
With reference to
The various aspects disclosed herein may also be configured to work with robotic surgical systems and what is commonly referred to as “Telesurgery.” Such systems employ various robotic elements to assist the clinician and allow remote operation (or partial remote operation) of surgical instrumentation. Various robotic arms, gears, cams, pulleys, electric and mechanical motors, etc. may be employed for this purpose and may be designed with a robotic surgical system to assist the clinician during the course of an operation or treatment. Such robotic systems may include remotely steerable systems, automatically flexible surgical systems, remotely flexible surgical systems, remotely articulating surgical systems, wireless surgical systems, modular or selectively configurable remotely operated surgical systems, etc.
The robotic surgical systems may be employed with one or more consoles that are next to the operating theater or located in a remote location. In this instance, one team of clinicians may prep the patient for surgery and configure the robotic surgical system with one or more of the instruments disclosed herein while another clinician (or group of clinicians) remotely controls the instruments via the robotic surgical system. As can be appreciated, a highly skilled clinician may perform multiple operations in multiple locations without leaving his/her remote console which can be both economically advantageous and a benefit to the patient or a series of patients. For a detailed description of exemplary medical work stations and/or components thereof, reference may be made to U.S. Patent Application Publication No. 2012/0116416, and PCT Application Publication No. WO2016/025132, the entire contents of each of which are incorporated by reference herein.
It should be understood that the disclosed structure can include any suitable mechanical, electrical, and/or chemical components for operating the disclosed system or components thereof. For instance, such electrical components can include, for example, any suitable electrical and/or electromechanical, and/or electrochemical circuitry, which may include or be coupled to one or more printed circuit boards. As appreciated, the disclosed computing devices (and/or servers), such as the disclosed camera 332, can include, for example, a “controller,” “processor,” “digital processing device” and like terms, and which are used to indicate a microprocessor or central processing unit (CPU). The CPU is the electronic circuitry within a computer that carries out the instructions of a computer program by performing the basic arithmetic, logical, control and input/output (I/O) operations specified by the instructions, and by way of non-limiting examples, include server computers. In some aspects, the controller includes an operating system configured to perform executable instructions. The operating system is, for example, software, including programs and data, which manages hardware of the disclosed apparatus and provides services for execution of applications for use with the disclosed apparatus. Those of skill in the art will recognize that suitable server operating systems include, by way of non-limiting examples, FreeBSD, OpenBSD, NetBSD®, Linux, Apple® Mac OS X Server®, Oracle® Solaris®, Windows Server®, and Novell® NetWare®. In some aspects, the operating system is provided by cloud computing.
In some aspects, the term “controller” may be used to indicate a device that controls the transfer of data from a computer or computing device to a peripheral or separate device and vice versa, and/or a mechanical and/or electromechanical device (e.g., a lever, knob, etc.) that mechanically operates and/or actuates a peripheral or separate device.
In aspects, the controller includes a storage and/or memory device. The storage and/or memory device is one or more physical apparatus used to store data or programs on a temporary or permanent basis. In some aspects, the controller includes volatile memory and requires power to maintain stored information. In various aspects, the controller includes non-volatile memory and retains stored information when it is not powered. In some aspects, the non-volatile memory includes flash memory. In certain aspects, the non-volatile memory includes dynamic random-access memory (DRAM). In some aspects, the non-volatile memory includes ferroelectric random-access memory (FRAM). In various aspects, the non-volatile memory includes phase-change random access memory (PRAM). In certain aspects, the controller is a storage device including, by way of non-limiting examples, CD-ROMs, DVDs, flash memory devices, magnetic disk drives, magnetic tapes drives, optical disk drives, and cloud-computing-based storage. In various aspects, the storage and/or memory device is a combination of devices such as those disclosed herein.
In various aspects, the memory can be random access memory, read-only memory, magnetic disk memory, solid state memory, optical disc memory, and/or another type of memory. In various aspects, the memory can be separate from the controller and can communicate with the processor through communication buses of a circuit board and/or through communication cables such as serial ATA cables or other types of cables. The memory includes computer-readable instructions that are executable by the processor to operate the controller. In various aspects, the controller may include a wireless network interface to communicate with other computers or a server. In aspects, a storage device may be used for storing data. In various aspects, the processor may be, for example, without limitation, a digital signal processor, a microprocessor, an ASIC, a graphics processing unit (“GPU”), field-programmable gate array (“FPGA”), or a central processing unit (“CPU”).
The memory stores suitable instructions and/or applications, to be executed by the processor, for receiving the sensed data (e.g., sensed data from camera), accessing storage device of the controller, generating a raw image based on the sensed data, comparing the raw image to a calibration data set, identifying an object based on the raw image compared to the calibration data set, transmitting object data to a post-processing unit, and displaying the object data to a graphic user interface. Although illustrated as part of the disclosed structure, it is also contemplated that a controller may be remote from the disclosed structure (e.g., on a remote server), and accessible by the disclosed structure via a wired or wireless connection. In aspects where the controller is remote, it is contemplated that the controller may be accessible by, and connected to, multiple structures and/or components of the disclosed system.
The term “application” may include a computer program designed to perform particular functions, tasks, or activities for the benefit of a user. Application may refer to, for example, software running locally or remotely, as a standalone program or in a web browser, or other software which would be understood by one skilled in the art to be an application. An application may run on the disclosed controllers or on a user device, including for example, on a mobile device, an IOT device, or a server system.
In some aspects, the controller includes a display to send visual information to a user. In various aspects, the display is a cathode ray tube (CRT). In various aspects, the display is a liquid crystal display (LCD). In certain aspects, the display is a thin film transistor liquid crystal display (TFT-LCD). In aspects, the display is an organic light emitting diode (OLED) display. In certain aspects, on OLED display is a passive-matrix OLED (PMOLED) or active-matrix OLED (AMOLED) display. In aspects, the display is a plasma display. In certain aspects, the display is a video projector. In various aspects, the display is interactive (e.g., having a touch screen) that can detect user interactions/gestures/responses and the like. In some aspects, the display is a combination of devices such as those disclosed herein.
The controller may include or be coupled to a server and/or a network. As used herein, the term “server” includes “computer server,” “central server,” “main server,” and like terms to indicate a computer or device on a network that manages the disclosed apparatus, components thereof, and/or resources thereof. As used herein, the term “network” can include any network technology including, for instance, a cellular data network, a wired network, a fiber-optic network, a satellite network, and/or an IEEE 802.11a/b/g/n/ac wireless network, among others.
In various aspects, the controller can be coupled to a mesh network. As used herein, a “mesh network” is a network topology in which each node relays data for the network. All mesh nodes cooperate in the distribution of data in the network. It can be applied to both wired and wireless networks. Wireless mesh networks can be considered a type of “Wireless ad hoc” network. Thus, wireless mesh networks are closely related to Mobile ad hoc networks (MANETs). Although MANETs are not restricted to a specific mesh network topology, Wireless ad hoc networks or MANETs can take any form of network topology. Mesh networks can relay messages using either a flooding technique or a routing technique. With routing, the message is propagated along a path by hopping from node to node until it reaches its destination. To ensure that all its paths are available, the network must allow for continuous connections and must reconfigure itself around broken paths, using self-healing algorithms such as Shortest Path Bridging. Self-healing allows a routing-based network to operate when a node breaks down or when a connection becomes unreliable. As a result, the network is typically quite reliable, as there is often more than one path between a source and a destination in the network. This concept can also apply to wired networks and to software interaction. A mesh network whose nodes are all connected to each other is a fully connected network.
In some aspects, the controller may include one or more modules. As used herein, the term “module” and like terms are used to indicate a self-contained hardware component of the central server, which in turn includes software modules. In software, a module is a part of a program. Programs are composed of one or more independently developed modules that are not combined until the program is linked. A single module can contain one or several routines, or sections of programs that perform a particular task.
As used herein, the controller includes software modules for managing various aspects and functions of the disclosed system or components thereof.
The disclosed structure may also utilize one or more controllers to receive various information and transform the received information to generate an output. The controller may include any type of computing device, computational circuit, or any type of processor or processing circuit capable of executing a series of instructions that are stored in memory. The controller may include multiple processors and/or multicore central processing units (CPUs) and may include any type of processor, such as a microprocessor, digital signal processor, microcontroller, programmable logic device (PLD), field programmable gate array (FPGA), or the like. The controller may also include a memory to store data and/or instructions that, when executed by the one or more processors, cause the one or more processors to perform one or more methods and/or algorithms.
The phrases “in an aspect,” “in aspects,” “in various aspects,” “in some aspects,” or “in other aspects” may each refer to one or more of the same or different aspects in accordance with the present disclosure. A phrase in the form “A or B” means “(A), (B), or (A and B).” A phrase in the form “at least one of A, B, or C” means “(A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C).”
It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).
Certain aspects of the present disclosure may include some, all, or none of the above advantages and/or one or more other advantages readily apparent to those skilled in the art from the drawings, descriptions, and claims included herein. Moreover, while specific advantages have been enumerated above, the various aspects of the present disclosure may include all, some, or none of the enumerated advantages and/or other advantages not specifically enumerated above.
The aspects disclosed herein are examples of the disclosure and may be embodied in various forms. For instance, although certain aspects herein are described as separate, each of the aspects herein may be combined with one or more of the other aspects herein. Specific structural and functional details disclosed herein are not to be interpreted as limiting, but as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures.
Any of the herein described methods, programs, algorithms, or codes may be converted to, or expressed in, a programming language or computer program. The terms “programming language” and “computer program,” as used herein, each include any language used to specify instructions to a computer, and include (but is not limited to) the following languages and their derivatives: Assembler, Basic, Batch files, BCPL, C, C+, C++, Delphi, Fortran, Java, JavaScript, machine code, operating system command languages, Pascal, Perl, PL1, scripting languages, Visual Basic, metalanguages which themselves specify programs, and all first, second, third, fourth, fifth, or further generation computer languages. Also included are database and other data schemas, and any other meta-languages. No distinction is made between languages which are interpreted, compiled, or use both compiled and interpreted approaches. No distinction is made between compiled and source versions of a program. Thus, reference to a program, where the programming language could exist in more than one state (such as source, compiled, object, or linked) is a reference to any and all such states. Reference to a program may encompass the actual instructions and/or the intent of those instructions.
As can be appreciated, securement of any of the components of the disclosed systems can be effectuated using known securement techniques such welding, crimping, gluing, fastening, etc.
Persons skilled in the art will understand that the structures and methods specifically described herein and illustrated in the accompanying figures are non-limiting exemplary aspects, and that the description, disclosure, and figures should be construed merely as exemplary of particular aspects. It is to be understood, therefore, that the present disclosure is not limited to the precise aspects described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, it is envisioned that the elements and features illustrated or described in connection with one exemplary aspect may be combined with the elements and features of another without departing from the scope of the present disclosure, and that such modifications and variations are also intended to be included within the scope of the present disclosure. Indeed, any combination of any of the presently disclosed elements and features is within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not to be limited by what has been particularly shown and described.
This application claims the benefit of U.S. Provisional Patent Application No. 63/159,651, filed Mar. 11, 2021, the entire disclosure of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63159651 | Mar 2021 | US |
