Wireless array for surgical stapler

Abstract

The present disclosure provides a circular stapler. The circular stapler includes a stapling head assembly, an anvil removably attachable to the stapling head assembly, and a handle assembly. The handle assembly includes a handle controller, a connector, and a handle transceiver configured to wirelessly transmit a first signal to an external hub. The handle transceiver is separate from the handle controller and is in electrical communication with the handle controller via the connector.

Description

Technical Field

[0001] The present disclosure generally describes a surgical instrument having multiple transceivers that can transmit information from the end of the surgical instrument, and more particularly, transmit information to a surgical stapler having an anvil transceiver and a handle transceiver that receives signals from the anvil transceiver. Background Art

[0002] In some surgical procedures (e.g., colorectal, bariatric, thoracic, etc.), portions of a patient's digestive tract (e.g., gastrointestinal tract and / or esophagus, etc.) may be cut and removed to remove unwanted tissue or for other reasons. Once the tissue is removed, the remaining portions of the digestive tract can be joined together in an end-to-end anastomosis. An end-to-end anastomosis can provide a substantially unobstructed flow path from one part of the digestive tract to another part of the digestive tract and does not cause any type of leakage at the site of the anastomosis.

[0003] One example of an instrument that can be used to provide an end-to-end anastomosis is a circular stapler. Some such staplers are operable to grasp tissue layers, cut through the grasped tissue layers, and drive staples through the grasped tissue layers to substantially seal the tissue layers together near the severed ends of the tissue layers, thereby joining the two severed ends of an anatomical cavity together. A circular stapler is configured to be able to cut and seal tissue substantially simultaneously. For example, a circular stapler can cut excess tissue located within an annular array of staples at the anastomosis to provide a substantially smooth transition between anatomical cavity segments joined at the anastomosis. Circular staplers can be used in open surgery or endoscopic surgery. In some cases, a portion of the circular stapler is inserted through a natural orifice of the patient.

[0004] Accordingly, the distal end of the circular stapler is positioned within the patient. The distal end may include a staple head assembly that can generate different types of digital information. Thus, an inherent problem with circular staplers is that the distal end can become separated from the proximal handle end, and thus it is difficult to transmit this digital information from the staple head assembly to an external device, such as a computer in the operating room. Accordingly, there is a need for an improved circular stapler design that can improve signal transmission from the staple head assembly within the patient to an external hub. Summary of the Invention

[0005] The present disclosure provides a solution to the above needs. One aspect of the present disclosure provides a surgical device. The device may include a suture head assembly. The device may include an anvil that can be detachably attached to the suture head assembly. The device may include a handle assembly. The handle assembly may include a handle controller, a connector, and a handle transceiver configured to be able to wirelessly transmit a first signal to an external hub. The handle transceiver may be separable from the handle controller and may be in electrical communication with the handle controller via the connector.

[0006] In any of the embodiments described herein, the handle assembly may include a knob that can be rotated to adjust the gap distance between the anvil surface and the handle assembly. The handle transceiver may be positioned within the knob.

[0007] In any of the embodiments described herein, the handle assembly may include a pistol grip. The handle transceiver may be positioned within the pistol grip.

[0008] In any of the embodiments described herein, the handle transceiver may be encapsulated within a shield to protect the handle transceiver from signal noise from the motor.

[0009] In any of the embodiments described herein, the handle assembly may include a battery housing and a housing cavity, the battery housing including a battery, the housing cavity being sized to receive the battery housing. The battery housing may be insertable and removable from the housing cavity. The handle transceiver may be positioned on the battery housing.

[0010] In any of the embodiments described herein, the handle assembly may include a first connector positioned on the battery housing and in electrical communication with the handle transceiver and a second connector positioned within the housing cavity and in electrical communication with the handle controller. The first connector and the second connector may be configured to be able to contact each other when the battery housing is positionable within the housing cavity.

[0011] In any of the embodiments described herein, the handle assembly may include a battery housing and a housing cavity, the battery housing including a battery, the housing cavity being sized to receive the battery housing. The battery housing may be insertable and removable from the housing cavity. The handle transceiver may be positioned within the housing cavity.

[0012] In any of the embodiments described herein, the handle assembly may include a display positioned on a display panel visible from the outside of the handle assembly. The handle transceiver may be positioned on the display panel.

[0013] In any of the embodiments described herein, the anvil can be removably attached to the suture head assembly and can include one or more sensors configured to be able to output a signal to the handle controller.

[0014] In any of the embodiments described herein, the anvil may include an anvil transceiver. One or more sensors may be configured to be capable of generating a second signal including first sensor data. One or more sensors may be configured to be capable of sending a first signal to the anvil transceiver. The handle transceiver may be configured to be capable of wirelessly communicating with the anvil transceiver and may operate as a wireless repeater between the anvil transceiver and an external hub.

[0015] One aspect of the present disclosure provides a surgical device. The device may include a suturing head assembly. The suturing head assembly may include a platform surface, an array of staple openings formed through the platform surface, and a plurality of staples associated with the array of staple openings. The suturing head assembly may be operable to drive staples through the array of staple openings. The device may include an anvil that is removably attachable to the suturing head assembly. The anvil may include an anvil surface configured to compress tissue against the platform surface. The anvil surface may define an array of staple forming pits. The anvil may include an anvil power source. The anvil may include an anvil transceiver. The device may include a handle assembly. The handle assembly may include a handle controller and a handle transceiver configured to be capable of wirelessly communicating with both the anvil transceiver and an external hub. The handle transceiver may operate as a wireless repeater to receive a first signal from the anvil transceiver and send a second signal to the external hub.

[0016] In any of the embodiments described herein, the anvil may further include a position sensor operable to detect the orientation of the anvil within a patient. The first signal may include information related to the orientation of the anvil.

[0017] In any of the embodiments described herein, the anvil may further include a surface sensor positioned on the anvil surface. The surface sensor may be operable to detect contact of tissue on the anvil surface. The first signal may include information related to the contact.

[0018] In any of the embodiments described herein, the surface sensor may be one of a plurality of surface sensors. The plurality of surface sensors are configured to be capable of detecting compression of tissue between the anvil surface and the platform surface.

[0019] In any of the embodiments described herein, the anvil may further include a plurality of staple pit sensors, each staple pit sensor positioned within one of the staple forming pits and configured to be capable of detecting contact of a staple. The first signal may include information from one or more of the plurality of staple pit sensors.

[0020] In any of the embodiments described herein, the handle assembly may include a knob that is rotatable to adjust a gap distance between the anvil surface and the platform surface. The handle transceiver may be positioned within the knob.

[0021] In any of the embodiments described herein, the handle assembly may include a pistol grip. The handle transceiver may be positioned within the pistol grip.

[0022] In any of the embodiments described herein, the handle transceiver may be encapsulated within a shroud to protect the handle transceiver from signal noise from the motor.

[0023] In any of the embodiments described herein, the handle assembly may include a battery housing that includes a battery. The handle assembly may include a housing cavity sized to receive the battery housing. The battery housing may be insertable and removable from the housing cavity. The handle transceiver may be positioned on the battery housing.

[0024] In any of the embodiments described herein, the handle assembly may include a first connector positioned on the battery housing and in electrical communication with the handle transceiver, and may include a second connector positioned within the housing cavity and in electrical communication with the handle controller. The first connector and the second connector may be configured to be able to contact each other when the battery housing is positionable within the housing cavity.

[0025] In any of the embodiments described herein, the handle assembly may include a battery housing and a housing cavity, the battery housing includes a battery, the housing cavity is sized to receive the battery housing. The battery housing may be insertable and removable from the housing cavity. The handle transceiver may be positioned within the housing cavity.

[0026] In any of the embodiments described herein, the handle assembly may include a display positioned on a display panel visible from the exterior of the handle assembly. The handle transceiver may be positioned on the display panel.

[0027] In any of the embodiments described herein, the first signal and the second signal may be sent at different frequencies.

[0028] One aspect of the present disclosure provides a surgical device. The device may include a suturing head assembly. The device may include an anvil that is removably attachable to the suturing head assembly and includes an anvil transceiver and one or more sensors. The one or more sensors may be configured to be able to generate a first signal including first sensor data, and may be configured to be able to send the first signal to the anvil transceiver for the anvil transceiver to transmit. The device may include a handle assembly. The handle assembly may include a handle controller and a handle transceiver configured to be able to communicate wirelessly with the anvil transceiver and receive the first signal.

[0029] In any of the embodiments described herein, the handle transceiver may operate as a wireless repeater to receive the first signal from the anvil transceiver and send a second signal to an external hub.

[0030] In any of the embodiments described herein, the second signal may include first sensor data.

[0031] In any of the embodiments described herein, the first signal and the second signal may be transmitted at different frequencies.

[0032] In any of the embodiments described herein, one or more sensors may include a position sensor operable to detect the orientation of the anvil within a patient. The first sensor data may include information related to the orientation of the anvil.

[0033] In any of the embodiments described herein, the handle assembly may include a battery housing and a housing cavity sized to receive the battery housing. The battery housing may be insertable and removable from the housing cavity. A handle transceiver may be positioned on the battery housing.

[0034] In any of the embodiments described herein, the handle assembly may include a display positioned on a display panel visible from the exterior of the handle assembly. The handle transceiver may be positioned on the display panel. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Although this specification concludes with claims that particularly point out and distinctly claim this technology, it is believed that the technology will be better understood from the following examples, which are described in conjunction with the accompanying drawings, in which like reference numerals indicate the same elements, and in which:

[0036] Figure 1 A perspective view of an exemplary circular stapler in accordance with one aspect of the present disclosure is depicted;

[0037] Figure 2 A perspective view of a Figure 1 circular stapler in accordance with one aspect of the present disclosure, in which the battery pack is removed from the handle assembly and the anvil is removed from the staple head assembly;

[0038] Figure 3 A perspective view of the anvil of a Figure 1 circular stapler in accordance with one aspect of the present disclosure is depicted;

[0039] Figure 4 A perspective view of the staple head assembly of a Figure 1 circular stapler in accordance with one aspect of the present disclosure is depicted.

[0040] Figure 5 A perspective view of the Figure 4 staple head assembly in accordance with one aspect of the present disclosure is depicted;

[0041] Figure 6 A perspective view of the Figure 1Exploded perspective view of a circular stapler, where the parts of the shaft assembly are shown separated from each other;

[0042] Figure 7A Depicts an anvil positioned within a first section of the digestive tract according to one aspect of the present disclosure, and Figure 3 a cross-sectional side view of a staple head assembly positioned within a second section of the digestive tract, where the anvil is separated from the staple head assembly; Figure 4

[0043] Figure 7B Figure 3 Depicts an anvil positioned within a first section of the digestive tract according to one aspect of the present disclosure, and Figure 4 a cross-sectional side view of a staple head assembly positioned within a second section of the digestive tract, where the anvil is fixed to the staple head assembly;

[0044] Figure 7C Figure 3 Figure 4 Depicts an anvil positioned within a first section of the digestive tract according to one aspect of the present disclosure, and a cross-sectional side view of a staple head assembly positioned within a second section of the digestive tract, where the anvil is retracted towards the staple head assembly, thereby clamping tissue between the anvil and the staple head assembly;

[0045] Figure 7D Figure 3 Figure 4 Depicts an anvil positioned within a first section of the digestive tract according to one aspect of the present disclosure, and

[0046] a cross-sectional side view of a staple head assembly positioned within a second section of the digestive tract, where the staple head assembly is actuated to cut and staple the clamped tissue; Figure 7E Figure 7A

[0047] Figure 8 Depicts a cross-sectional side view of a first section and a second section of the digestive tract joined together at an end-to-end anastomosis according to one aspect of the present disclosure; Figure 7A

[0047] Figure 8 Depicts a circular stapler having a handle transceiver positioned near a handle controller according to one aspect of the present disclosure;

[0048] Figure 9 Depicts a circular stapler where the handle transceiver is positioned within a proximal knob according to one aspect of the present disclosure;

[0049] Figure 10 Depicts a circular stapler where the handle transceiver is positioned within a pistol grip according to one aspect of the present disclosure;

[0050] Figure 11 ​Depicts a circular stapler according to one aspect of the present disclosure, wherein the handle transceiver is positioned within the battery housing;

[0051] Figure 12 Depicts a circular stapler according to one aspect of the present disclosure, wherein the handle transceiver is positioned within the housing cavity;

[0052] Figure 13A Depicts a circular stapler according to one aspect of the present disclosure, wherein the handle transceiver is positioned on the display panel;

[0053] Figure 13B Provides a detailed view of a display panel according to one aspect of the present disclosure;

[0054] Figure 14 Depicts an anvil having an anvil circuit board according to one aspect of the present disclosure;

[0055] Figure 15 Depicts an exemplary bottom plan view of an anvil that can be used with a circular stapler according to one aspect of the present disclosure and Figure 1 ;

[0056] Figure 16 Is a component diagram of an exemplary smart anvil according to one aspect of the present disclosure;

[0057] Figure 17 Depicts a system environment for an exemplary circular stapler and an external hub according to one aspect of the present disclosure; and

[0058] Figure 18 Is an exemplary schematic diagram of a smart circular stapler in use.

[0059] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology can be implemented in many other ways, including those not necessarily shown in the drawings. The drawings incorporated in and forming a part of this specification illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology; however, it should be understood that the technology is not limited to the exact arrangements shown. Detailed Description

[0060] The description of certain examples of the present technology should not be used to limit the scope of the present technology. From the following description, other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art. The following description is given by way of example, which is one of the best ways contemplated for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all of which do not depart from the present technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0061] I. Overview of Exemplary Circular Stapling Surgical Instruments

[0062] Figure 1 and Figure 2 depicts an exemplary surgical circular stapler (10) that can be used to provide an end-to-end anastomosis between two segments of an anatomical lumen (such as a portion of a patient's digestive tract). The circular stapler (10) of this example includes a handle assembly (100), a shaft assembly (200), a staple head assembly (300), an anvil (400), and a removable battery pack (120). Each of these components will be described in more detail below.

[0063] A. Exemplary Tissue Engaging Features of Circular Stapling Instruments

[0064] As can be seen most clearly in Figure 3 , the anvil (400) of this example includes a head (420) and a shank (410). The head (410) includes a proximal surface (412) that defines a plurality of staple-forming pits (414). In this example, the staple-forming pits (414) are arranged in two concentric annular arrays. The staple-forming pits (414) are configured to deform the staples (e.g., from a generally "U" shape to a "B" shape as known in the art) when the staples are driven into the staple-forming pits (414). The shank (420) defines a hole or lumen (422) and includes a pair of pivot latch members (430) positioned within the hole (422). Each latch member (430) includes features that allow the anvil (400) to be removably fixed to the trocar (330) of the staple head assembly (300), as will be described in more detail below. It should be understood, however, that any other suitable components, features, or techniques can be used to removably fix the anvil (400) to the trocar (330).

[0065] The staple head assembly (300) is located at the distal end of the shaft assembly (200). As Figure 1 and Figure 2 shown, the anvil (400) is configured to be removably coupled to the shaft assembly (200) adjacent to the staple head assembly (300). Moreover, as will be described in more detail below, the anvil (400) and the staple head assembly (300) are configured to cooperate to manipulate tissue in three ways, including clamping tissue, cutting tissue, and suturing tissue. As in Figure 4 and Figure 5For optimal display, the stapling head assembly (300) of this example includes a tubular housing (310) that houses a slidable staple driving member (350). A cylindrical core member (312) extends distally within the tubular housing (310). The tubular housing (310) is fixedly secured to the outer sheath (210) of the shaft assembly (200) such that the tubular housing (310) serves as a mechanical ground for the stapling head assembly (300).

[0066] The trocar (330) is coaxially positioned within the core member (312) of the tubular housing (310). The trocar (330) is operable to translate distally and proximally relative to the tubular housing (310) in response to rotation of a knob (130) located at the proximal end of the handle assembly (100). The trocar (330) includes a shaft (332) and a head (334). The head (334) includes a pointed distal end (336) and a proximally extending surface (338). The head (334) and the distal portion of the shaft (332) are configured to be inserted into a hole (422) of the anvil (400). The proximally extending surface (338) is configured to complement features of a latching member (430) to provide a snap-fit engagement between the anvil (400) and the trocar (330).

[0067] The staple driving member (350) is operable to longitudinally actuate within the tubular housing (310) in response to activation of a motor (160), as will be described in more detail below. The staple driving member (350) includes two distally presented concentric annular arrays of staple drivers (352). The staple drivers (352) are arranged to correspond to the arrangement of the above-described staple forming pits (414). Accordingly, each staple driver (352) is configured to drive a corresponding staple into a corresponding staple forming pit (414) when the stapling head assembly (300) is actuated. The staple driving member (350) also defines a hole (354) that is configured to coaxially receive the core member (312) of the tubular housing (310).

[0068] A cylindrical knife member (340) is coaxially positioned within the staple driving member (350). The knife member (340) includes a sharp, circular cutting edge (342) presented distally. The knife member (340) is sized such that the knife member (340) defines an outer diameter that is less than the diameter defined by the inner annular array of staple drivers (352). The knife member (340) also defines an opening that is configured to coaxially receive the core member (312) of the tubular housing (310).

[0069] The platform member (320) is fixedly secured to the tubular housing (310). The platform member (320) includes a distally presented platform surface (322) defining staple openings (324) that define two concentric annular arrays. The staple openings (324) are arranged to correspond to the arrangement of the staple drivers (352) and staple forming pits (414) described above. Accordingly, each staple opening (324) is configured to provide a path for a corresponding staple driver (352) to drive a corresponding staple through the platform member (320) and into a corresponding staple forming pit (414) when the suture head assembly (300) is actuated. It should be understood that the arrangement of the staple openings (324) may be modified similar to the arrangement of the staple forming pits (414) described above. It should also be understood that various structures and techniques may be used to hold the staples within the suture head assembly (300) before the suture head assembly (300) is actuated. The inner diameter defined by the platform member (320) is only slightly larger than the outer diameter defined by the blade member (340). Accordingly, the platform member (320) is configured to allow the blade member (340) to translate distally to a point where the cutting edge (342) is away from the platform surface (322).

[0070] Figure 6 Various components of the shaft assembly (200) are shown that extend distally from the handle assembly (100) and couple components of the suture head assembly (300) to components of the handle assembly (100). Specifically and as described above, the shaft assembly (200) includes an outer sheath (210) that extends between the handle assembly (100) and the tubular housing (310). In this example, the outer sheath (210) is rigid and includes a preformed bend (212) that is configured to facilitate positioning the suture head assembly (300) within a patient's colon as described below. The bend (212) includes an inner bend (216) and an outer bend (214).

[0071] The shaft assembly (200) further includes a trocar actuating rod (220) and a trocar actuating band assembly (230). The distal end of the trocar actuating band assembly (230) is fixedly secured to the proximal end of the trocar shaft (332). The proximal end of the trocar actuating band assembly (230) is fixedly secured to the distal end of the trocar actuating rod (220) such that the trocar (330) will translate longitudinally relative to the outer sheath (210) in response to translation of the trocar actuating band assembly (230) and the trocar actuating rod (220) relative to the outer sheath (210). The trocar actuating band assembly (230) is configured to be bendable such that the trocar actuating band assembly (230) can advance along a preformed curve within the shaft assembly (200) when the trocar actuating band assembly (230) translates longitudinally relative to the outer sheath (210). However, the trocar actuating band assembly (230) has sufficient column strength and tensile strength to transfer distal and proximal forces from the trocar actuating rod (220) to the trocar shaft (332). The trocar actuating rod (220) is rigid. A clamp (222) is fixedly secured to the trocar actuating rod (220) and is configured to cooperate with complementary features within the handle assembly (100) to prevent rotation of the trocar actuating rod (220) within the handle assembly (100) while still allowing longitudinal translation of the trocar actuating rod (220) within the handle assembly (100). The trocar actuating rod (220) further includes a coarse helical thread (224) and a fine helical thread (226).

[0072] The shaft assembly (200) further includes a suture head assembly driver (240) slidably received within the outer sheath (210). The distal end of the suture head assembly driver (240) is fixed to the proximal end of the staple driving member (350). The proximal end of the suture head assembly driver (240) is fixed to the drive carriage (250) via a pin (242). It should thus be understood that the staple driving member (350) will translate longitudinally relative to the outer sheath (210) in response to translation of the suture head assembly driver (240) and the drive carriage (250) relative to the outer sheath (210). The suture head assembly driver (240) is configured to be bendable such that the suture head assembly driver (240) can advance along a preformed curve within the shaft assembly (200) when the suture head assembly driver (240) translates longitudinally relative to the outer sheath (210). However, the suture head assembly driver (240) has sufficient column strength to transfer distal force from the drive carriage (250) to the staple driving member (350).

[0073] B. Exemplary User Input Features of Circular Stapling Instruments

[0074] As Figure 1As shown, the handle assembly (100) includes a pistol grip (112) and several components that can be operated to actuate the anvil (400) and the suture head assembly (300). Specifically, the handle assembly (100) includes a knob (130), a safety trigger (140), a firing trigger (150), a motor (160), and a motor activation module (180). The knob (130) is coupled to the trocar actuating rod (220) via a nut (not shown) such that the coarse helical threads (224) will selectively engage the thread engagement features inside the nut; and such that the fine helical threads (226) will selectively engage the thread engagement features inside the knob (130). These complementary structures are configured such that the trocar actuating rod (220) will first translate proximally at a relatively slow rate in response to rotation of the knob (130), and then translate proximally at a relatively fast speed.

[0075] It should be understood that when the anvil (400) is coupled to the trocar (330), rotation of the knob (130) will provide a corresponding translation of the anvil relative to the suture head assembly (300). It should also be understood that the knob (130) can be rotated in a first angular direction (e.g., clockwise) to retract the anvil (400) toward the suture head assembly (300); and can be rotated in a second angular direction (e.g., counterclockwise) to advance the anvil (400) away from the suture head assembly (300). Thus, the knob (130) can be used to adjust the gap distance between the opposing surfaces (412, 322) of the anvil (400) and the suture head assembly (300) until an appropriate gap distance is achieved.

[0076] In this example, the handle assembly (100) includes a user feedback feature (114) that is configured to provide visual feedback to the operator indicating the positioning of the anvil (400) relative to the suture head assembly (300). Thus, the operator can observe the user feedback feature (114) while rotating the knob (130) to confirm whether an appropriate gap distance has been achieved between the anvil (400) and the suture head assembly (300).

[0077] The firing trigger (150) is operable to activate the motor (160) to actuate the suture head assembly (300). The safety trigger (140) is operable to selectively prevent actuation of the firing trigger (150) based on the longitudinal position of the anvil (400) relative to the suture head assembly (300). The handle assembly (100) further includes a component operable to selectively lock both triggers (140, 150) based on the position of the anvil (400) relative to the suture head assembly (300). When the triggers (140, 150) are locked, actuation of the firing trigger (150) to fire the suture head assembly (300) is prevented. Thus, the trigger (150) is only operable to initiate actuation of the suture head assembly (300) when the position of the anvil (400) relative to the suture head assembly (300) is within a predetermined range.

[0078] In an example, the firing trigger (150) of the present example includes an integral actuation paddle. The paddle is configured to actuate a switch of the motor activation module (180) when the firing trigger (150) is pivoted to the firing position ( Figure 1 ). The motor activation module (180) communicates with the battery pack (120) and the motor (160) such that the motor activation module (180) is configured to provide power from the battery pack (120) for activation of the motor (160) in response to the paddle actuating the switch of the motor activation module (180). Thus, the motor (160) will be activated when the firing trigger (150) is pivoted. This activation of the motor (160) will actuate the suture head assembly (300), as described in more detail below.

[0079] The battery pack (120) is operable to provide power to the motor (160), as described above. The battery pack (120) may be removably coupled to the handle assembly (100) by snap fit or any other suitable means. It should be understood that the battery pack (120) and the handle assembly (100) may have complementary electrical contacts, pins, and sockets, and / or other features that provide a path for electrical communication from the battery pack (120) to the electrical components in the handle assembly (100) when the battery pack (120) is coupled to the handle assembly (100). It should also be understood that in some configurations, the battery pack (120) is integrally incorporated within the handle assembly (100) such that the battery pack (120) cannot be removed from the handle assembly (100). As will be discussed in more detail below, the battery pack (120) may consist of a battery (122) and a battery housing (608). The battery housing (608) may be an outer housing of the battery pack (120) that is connected to or otherwise engages the handle assembly (see, for example Figure 8 ). The battery pack (120) may be inserted into a housing cavity (610) within the handle assembly (100).

[0080] C. Exemplary Anastomosis Procedures Using Circular Stapling Instruments

[0081] Figures 7A through 7E A circular stapler (10) is shown for forming an anastomosis (70) between two tubular anatomical structures (20, 40). By way of example only, the tubular anatomical structures (20, 40) may include segments of a patient's esophagus, segments of a patient's colon, other segments of a patient's digestive tract, or any other tubular anatomical structure. In some forms, one or more diseased portions of a patient's colon are removed, wherein Figures 7A through 7E the tubular anatomical structures (20, 40) represent the remaining transected portions of the colon.

[0082] As Figure 7A shown, an anvil (400) is positioned within one tubular anatomical structure (20), and a staple head assembly (300) is positioned within the other tubular anatomical structure (40). In forms where the tubular anatomical structures (20, 40) include segments of a patient's colon, the staple head assembly (300) may be inserted via the patient's rectum. It should also be understood that Figures 7A through 7E the surgery shown is an open surgery, although the surgery may alternatively be performed laparoscopically. By way of example only, the surgery may be performed laparoscopically. Various other suitable ways in which the circular stapler (10) can be used to form an anastomosis (70) in a laparoscopic surgery will be apparent to those of ordinary skill in the art in light of the teachings herein.

[0083] As Figure 7A shown, the anvil (400) is positioned within the tubular anatomical structure (20) such that the handle (420) projects from the open transected end (22) of the tubular anatomical structure (20). A purse string suture (30) is disposed around an intermediate region of the handle (420) to generally fix the position of the anvil (400) within the tubular anatomical structure (20). Similarly, the staple head assembly (300) is positioned within the tubular anatomical structure (40) such that the trocar (330) projects from the open transected end (42) of the tubular anatomical structure (20). A purse string suture (50) is disposed around an intermediate region of the shaft (332) to generally fix the position of the staple head assembly (300) within the tubular anatomical structure (40).

[0084] Next, the anvil (400) is secured to the trocar (330) by inserting the trocar (330) into the aperture (422), as Figure 7BAs shown. The latch member (430) engages the head (334) of the trocar (330), thereby providing a secure fit between the anvil (400) and the trocar (330). Then, the operator rotates the knob (130) while holding the handle assembly (100) stationary via the pistol grip (112). This rotation of the knob (130) causes the trocar (330) and the anvil (400) to retract proximally (as described above). As Figure 7C shown, this proximal retraction of the trocar (330) and the anvil (400) compresses the tissue of the tubular anatomical structures (20, 40) between the surfaces (412, 322) of the anvil (400) and the suture head assembly (300). The operator observes the user feedback feature (114) to determine whether the gap distance (d) between the opposing surfaces (412, 322) of the anvil (400) and the suture head assembly (300) is appropriate; and makes any necessary adjustments via the knob (130).

[0085] Once the operator has appropriately set the gap distance (d) via the knob (130), the operator actuates the safety trigger (140) to cause the actuation of the firing trigger (150). Then, the operator actuates the firing trigger (150). This actuation of the firing trigger (150) in turn actuates the switch of the motor activation module (180), which in turn starts the motor (160), thereby actuating the suture head assembly (300) by driving the knife member (340) and the staple driver member (350) distally, as Figure 7D shown. As the knife member (340) translates distally, the cutting edge (342) of the knife member (340) cooperates with the inner edge (416) of the anvil (400), thereby shearing the excess tissue located within the annular recess (418) of the anvil (400) and the interior of the knife member (340).

[0086] As Figure 4 shown, the anvil (400) of the present example includes a severable washer (417) within the annular recess (418). When the knife member (340) moves from Figure 7C the position shown to Figure 7DWhen the full distal range of motion is completed at the position shown, this washer (417) is severed by the knife member (340). When the knife member (340) reaches the end of its distal movement, the drive mechanism of the knife member (340) can provide an increased mechanical advantage, thereby providing a greater force to sever the washer (417). Of course, in some forms, the severable washer (417) can be completely omitted. In forms that include the washer (417), it should be understood that the washer (417) can also act as a cutting plate for the knife member (340) to assist in cutting tissue. In addition to or in place of the above-described shearing action between the inner edge (416) and the cutting edge (342), such cutting techniques can be employed.

[0087] When the staple driving member (350) translates distally from the Figure 7C position shown to the Figure 7D position shown, the staple driving member (350) drives a staple (90) through the tissue of the tubular anatomical structures (20, 40) and into the staple forming pit (414) of the anvil (400). The staple forming pit (414) deforms the staple (90) into a "B" shape known in the art. Thus, the formed staple (90) holds the ends of the tissue together, thereby joining the tubular anatomical structure (20) to the tubular anatomical structure (40).

[0088] After the operator has actuated the suture head assembly (300) as Figure 7D shown, the operator rotates the knob (130) to drive the anvil (400) distally away from the suture head assembly (300), thereby increasing the gap distance (d) to facilitate release of the tissue between the release surfaces (412, 322). Then, the operator removes the circular stapler (10) from the patient's body, with the anvil (400) still fixed to the trocar (330). Referring again to the example where the tubular anatomical structures (20, 40) include segments of the patient's colon, the circular stapler (10) can be removed via the patient's rectum. With the circular stapler (10) removed, the tubular anatomical structures (20, 40) are held together at the anastomosis (70) by two circumferential arrays of staples (90), as Figure 7E shown. The inner diameter of the anastomosis (70) is defined by the severed edge (60) left by the knife member (340).

[0089] In some cases, it may be desirable to change the configuration and arrangement of the staple forming pits (414) in the anvil (400). It should be understood that reconfiguring and rearranging the staple forming pits (414) can cause a reconfiguration and rearrangement of the staples (90) formed by the staple forming pits (414). For example, the configuration and arrangement of the staple forming pits (414) can affect the structural integrity of the anastomosis (70) secured by the staples (90). Additionally, the configuration and arrangement of the staple forming pits (414) can affect the hemostasis achieved at the anastomosis (70) secured by the staples (90). The following description relates to several exemplary variations of the anvil (400) to provide staple forming pit configurations and arrangements different from those of the staple forming pits (414).

[0090] It should be understood that the various alternatives of the anvil (400) described below can be readily used with the circular stapler (10) in place of the anvil (400). It should also be understood that in some cases, it may be necessary to change the configuration and arrangement of the staple openings (324) in the platform member (320) to be complementary to the configuration and arrangement of the alternative staple forming pits described below. In accordance with the teachings herein, the various suitable ways of incorporating the alternative anvils of the anvil (400) described below into the circular stapler (10) will be apparent to those of ordinary skill in the art.

[0091] The circular stapler (10) described herein may include intelligent components that generate data and send the data to other remote components. In one example, the circular stapler (10) may include an intelligent anvil (400), as will be described in more detail with respect to Figure 17 The anvil (400) is capable of generating signals inside the surgical site, such as information about the position of the anvil (400) (e.g., whether the anvil (400) is currently attached to the staple head assembly (300)) and / or information about the firing of the staples (90), such as the forces seen on the anvil (400) during the firing process. The anvil (400) can send data about these signals outside the patient's body. However, a problem with this scenario is that many radio frequencies and protocols (such as Wi-Fi TM and Bluetooth TM ) are susceptible to interference from human tissue, and thus the positioning of the antenna both inside and outside the patient's body is important. Figures 8 through 13BEach provides an example location of an antenna or transceiver (e.g., the handle transceiver (604)) within the handle assembly (100) that enables signals to be transmitted to a short distance within the handle assembly (still through tissue) and then to a long distance to an external hub (902) outside the patient. Additional information regarding the circular stapler can be found in U.S. Patent Publication No. 2018 / 0132849, entitled "Staple Forming Pocket Configurations For Circular Surgical Stapler Anvil", the entire disclosure of which is incorporated herein by reference.

[0092] Now referring to Figure 8 , this example depicts a circular stapler (10) having a handle transceiver (604) positioned near the handle controller (602) in accordance with one aspect of the present disclosure. Additional information regarding the handle controller (602) is provided below with respect to Figure 17 . Generally, the handle controller (602) may include hardware and / or software to assist in controlling (i.e., generating or receiving firing signals to and from the staple head assembly (300) or other components of the circular stapler (10) such as a motor (160)) or monitoring the device (i.e., generating or receiving information regarding previous staple firings of the device). Briefly referring to Figure 18 for illustration, the anvil (400) is positioned inside an occlusion (900) (e.g., the patient's abdomen) during operation. The anvil (400) is capable of generating the information regarding the stapling operation at the distal end of the device within the occlusion (900) and forwarding the information outside the occlusion (900). One particular implementation may be to transmit the information to an external hub (902), which may include an external computing system having a display for providing the information received from within the occlusion (900). The external hub (902) may be positioned many feet away from the circular stapler (10), and since the patient's tissue can be within the normal operating distance of such a device (e.g., for Bluetooth TM or Wi-Fi TMAt approximately 2.4 GHz) obstructs the signal, so the blockage may prevent the signal from reaching the hub (902). The fact that the circular stapler (10) has an anvil that can be detachably attached further exacerbates the above problem, which is different from what is found in linear staplers, and thus the anvil (400) can continuously change its position (and distance) from the handle assembly (100). In the present disclosure, the handle transceiver (604) can act as a repeater to both (i) receive short-range signals from the anvil transceiver (706) and (ii) send long-range signals to the hub (902). The improvement in this design is that the relay (i.e., the handle transceiver (604) is positioned as physically close as possible to the distal component (the anvil transceiver (706), i.e., the handle transceiver (604) is placed in the handle assembly. Thus, another inventive aspect of the present disclosure is the design herein (see Figures 8 through 13B ) each provides a solution for improving the wireless connection between the handle transceiver (604) and the anvil transceiver (706) on its own.

[0093] Referring again to the handle controller (602), in any of the embodiments described herein, the controller can be positioned within the handle assembly (100). As Figure 8 shown, the handle controller (602) is positioned near the housing cavity (610) that receives the battery housing (608). Positioning the handle controller (602) within the handle assembly (100) near the battery (122) within the battery housing (608) can help ensure a safe, secure, and direct connection to the power source. Additionally, and as described below with reference to Figure 13A and Figure 13B the handle assembly (100) may also include a display panel (618) that includes a display (620), and positioning the handle controller (602) on the upper portion of the handle assembly (100) enables the handle controller (602) to be positioned near the display panel (618). As described above, one aspect of the present disclosure is to provide a communication device between the handle assembly (100) and the anvil (400). Thus, the handle assembly (100) is configured to receive signals from the anvil (400). As shown, the handle transceiver (604) is positioned near the handle controller (602) to provide a short connection to the controller, and in some cases, the handle transceiver (604) can be positioned on the same circuit board that includes the handle controller (602). Figure 8The position of the handle transceiver (604) therein allows the transceiver to be positioned on the upper portion of the handle assembly (100) such that the transceiver has a clear and direct path to the anvil (400) positioned within the patient. As described above, the shaft assembly (200) may include a preformed bend (212) configured to facilitate positioning of the suture head assembly (300) within the patient's colon, and the bend may help to further align the anvil (400) in a direct path with less obstruction to the handle transceiver (604).

[0094] Figure 9 Depicted is a circular stapler (10) according to one aspect of the present disclosure, where the handle transceiver (604) is positioned within the proximal knob (130). The knob (130) is located at the proximal end of the handle assembly (100) and is the part of the handle assembly (100) that is furthest from the patient during operation. Thus, the knob (130) provides a preferred location for the handle transceiver (604). The handle (e.g., the pistol grip (112) and the knob (130) are both parts used by a surgeon (or surgical staff). Thus, these parts are located outside the patient (occlusion (900)), and thus will be effective relay locations as they can be guaranteed to have a minimal occlusion presence. However, in this position, the handle transceiver (604) is positioned within the handle assembly (100) distal to the handle controller (602). Thus, the handle transceiver (604) then cannot be positioned on the same circuit board as the handle controller (602), and communication between the two components can be accomplished by using a connector (606). This connector (606) can be a coaxial cable, etc., which enables the handle transceiver (604) to be positioned within the center of the knob (130) such that the knob (130) can freely rotate about the handle controller (602) itself.

[0095] Figure 10Depicts a circular stapler (10) according to an aspect of the present disclosure, where the handle transceiver (604) is positioned within the pistol grip (112). As described above, the handle assembly (100) may include a number of electronic components, such as a handle controller (602) and a motor (160). These components, particularly the motor (160), can generate electrical noise during operation, and thus the signal transmitted from the anvil (400) to the handle transceiver (604) can be degraded by radio frequency interference. The pistol grip (112) of the handle assembly (100) is a preferred location for positioning the handle transceiver (604) as far as possible from the handle controller (602) and the motor (160) to reduce the likelihood of interference. In some examples, a shield (612) may be placed between the handle transceiver (604) and other components of the handle assembly (100) to further reduce radio frequency interference from the electrical components therein. Common radio frequency shielding materials for the shield (612) may include aluminum, copper, electroplated steel, nickel silver, etc. Since Figure 10 the exemplary embodiment in [reference] has a handle transceiver (604) positioned distal to the handle controller (602), this embodiment may include a connector (606) for electrically connecting the handle transceiver (604) and the handle controller (602).

[0096] Figure 11 Depicts a circular stapler (10) according to an aspect of the present disclosure, where the handle transceiver (604) is positioned within the battery housing (608). As described above, the battery housing (608) of the battery pack (120) may be removably coupled to the handle assembly (100) by snap-fit engagement or any other suitable means. The battery housing (608) and the handle assembly (100) may have complementary electrical contacts, pins, and sockets, and / or other features that provide a path for electrical communication between the battery pack (120) and the handle assembly (100). For example, the circular stapler (10) may include a first connector (614) positioned on the battery housing (608) and in electrical communication with the handle transceiver (604) positioned on or within the battery housing (608). The handle assembly (100) may include a second connector (616) positioned within the housing cavity (610) and in electrical communication with the handle controller (602). The first connector (614) and the second connector (616) are configured to be able to contact each other when the battery housing (608) is positioned within the housing cavity (610). This connection enables the handle controller (602) to transmit signals to and receive signals from the handle transceiver (604). The second connector 616) may be electrically connected to the handle controller (602) via the connector (616) (as shown), or alternatively, the second connector (606) may be positioned on the same circuit board including the handle controller (602). Figure 10The position of the handle transceiver (604) also allows the transceiver to be positioned on the upper portion of the handle assembly (100) such that the transceiver has a clear and direct path to the anvil (400) positioned within the patient. As described above, the shaft assembly (200) can include a preformed bend (212) configured to facilitate positioning of the staple head assembly (300) within the patient's colon, and the bend can help to further align the anvil (400) in a direct path with less obstruction to the handle transceiver (604).

[0097] Figure 12 A circular stapler (10) is shown in accordance with one aspect of the present disclosure, where the handle transceiver (604) is positioned within the housing cavity (610). Figure 12 The example shown in is similar to that regarding Figure 11 the example shown and described. The difference here is that the handle transceiver (604) can be firmly positioned within the housing cavity (610) such that it cannot be removed with the battery housing (608). Thus, in this configuration, it is not necessary to include a first connector (614) and a second connector (616), but instead, the handle transceiver (604) can be electrically connected to the handle controller (602) via a connector (606) (as shown).

[0098] Figure 13A A circular stapler (10) is depicted in accordance with one aspect of the present disclosure, where the handle transceiver (604) is positioned on the display panel (618), and Figure 13B a detailed view of the display panel (618) is provided. As shown, the display panel (618) can be surface-mounted on the housing of the handle assembly (100), at the top of the handle assembly (100), and near the housing cavity (610). The display panel (618) can include a display (620) that provides information about the circular stapler (10) (e.g., information about the firing status, information about the status of the staples (90), etc.). The display (620) can be a light-emitting diode (LED), a liquid crystal display (LCD), etc. The handle transceiver (604) can be positioned near the display panel (618). Thus, the handle transceiver (604) positioned as such can be positioned near the handle controller (602) to provide a short connection to the controller, and in some cases, at least a portion of the handle transceiver (604) and the display (620) can be positioned on the same circuit board that includes the handle controller (602). Additionally, Figure 13A and Figure 13BThe position of the handle transceiver (604) in [the device] allows the transceiver to be positioned on the upper portion of the handle assembly (100) such that the transceiver has a clear and direct path to the anvil (400) positioned within the patient. As described above, the shaft assembly (200) may include a preformed curved portion (212) configured to facilitate positioning of the suture head assembly (300) within the patient's colon, and the curvature may further assist in aligning the anvil (400) in a direct path with less obstruction to the handle transceiver (604).

[0099] Figure 14 Depicted is an anvil (400) having an anvil circuit board (700) in accordance with one aspect of the present disclosure. The anvil (400) may include components that make the anvil (400) a “smart” component of the circular stapler (10). Thus, the anvil (400) can be an integrated component that can operate separately from the handle assembly (100), which is desirable since the anvil (400) is removably attachable relative to the head assembly (300). The anvil (400) thus includes a power source (702), a processor (704), a memory (708) (see Figure 16 ), and an anvil transceiver (706), each of which is positioned on the anvil circuit board (700); the electronic components can be sealed within the anvil (400) with an anvil top cover (710). The power source (702) can be a battery, such as a disposable or rechargeable lithium battery, etc. The anvil (400) may also include one or more sensors for detecting the state at the anvil (400). For example, the anvil (400) may include one or more position sensors (712), which may include one or more of a gyro sensor, an accelerometer, or a proximity sensor that can operate to detect the orientation of the anvil (400) within the patient. The gyro sensor and / or accelerometer can be used to determine how the anvil (400) is oriented within the patient. Since one aspect is inserting the trocar (330) into the lumen (422), it is helpful to be able to visualize the three-dimensional orientation of the anvil (400) within the patient (similar to roll, pitch, and yaw) such that the trocar (330) and the anvil (400) can be positioned to be aligned. The position sensor (712) including the gyro sensor and / or accelerometer can help achieve this visualization goal. In some examples, the handle assembly (100) may also include position sensors, such as a gyro sensor and / or an accelerometer. In this example, the position sensor in the handle assembly (100) can generate information about the orientation of the handle assembly, the position sensor (712) in the anvil (400) can generate information about the orientation of the anvil, and both sets of information can be forwarded to an external hub (902) to assist in aligning the trocar (330) and the lumen (422).

[0100] During operation, a proximity sensor, used as a position sensor (712), can be used to determine the proximity of the anvil (400) to the head assembly (300), as it is an objective to couple the anvil (400) to the head assembly (300) as described above - which is not expected in the case of a linear stapler, for example, because the end effectors (anvil and cartridge) in a linear stapler are connected to its handle. The aforementioned proximity sensor can include, for example, an ultrasonic proximity sensor, a magnetic proximity sensor, and similar proximity sensors that can provide proximity information even when tissue may be between the anvil (400) and the head assembly (300). Any position sensor (712) described herein can generate sensor data that includes information related to the orientation of the anvil (400). This information can be generated by the position sensor (712), sent to the processor (704) for processing, and then sent to the anvil transceiver (706) to be relayed to the handle transceiver (604). The handle transceiver (604) can then transmit the generated sensor data to an external hub (902), where it can be displayed to the user. The anvil 400 can include other types of sensors, as will be described below with respect to Figure 15 described.

[0101] Figure 15 An exemplary anvil (400) that can be used with one type of circular stapler (10) is shown. The anvil (400) of this example includes an inner annular array (502) that defines staple forming pits (510) and an outer annular array (504) of staple forming pits (550) (both are similar to the anvil surface (412) of the staple forming pits (414) described above). Briefly, the staple forming pits (510, 550) are arranged such that a radius line (RL) extending outward from the center of the anvil (400) passes through regions of the entry surfaces of the staple forming pits (510) and through regions of the entry surfaces of the staple forming pits (550). Thus, the staple forming pits (510, 550) can overlap along the radial dimension. A chamfered edge (508) extends around the outer perimeter of the proximal surface (506). It should be understood that the anvil (400) can be fixed to the trocar (330), the proximal surface (506) can be used to compress tissue against the platform surface (322), and the staple driver (352) can drive staples (90) through the tissue into the staple forming pits (510, 550) so as to thereby form staples (90) in the tissue.

[0102] The anvil (400) may include a surface sensor (802) positioned on the anvil surface (412). The surface sensor (802) is operable to detect contact of tissue on the anvil surface (412), generate a signal having information associated with the contact, send the generated signal to a processor (704) for processing such that the signal can be sent to an anvil transceiver (706) to be relayed to a handle transceiver (604). The information may be used to determine that the tissue is properly compressed between the anvil surface (412) and a platform surface (322) presented distally of the suture head assembly (300) (see Figure 4 ). In some examples, the surface sensor (802) is one of a plurality of surface sensors, and the plurality of surface sensors are configured to be able to detect compression of tissue between the anvil surface (412) and the platform surface (322). For example, the surface sensor (802) may measure tissue impedance at different regions on the anvil surface (412), compare the measured tissue impedance to a predetermined tissue impedance signal of the surface sensor (802), and detect an irregularity in at least one of a position or orientation of the tissue between the anvil surface (412) and the platform surface (322) presented distally of the suture head assembly (300) (see Figure 4 ). Compression through the tissue can be determined based on the impedance of the tissue. At various compression levels, the impedance Z of the tissue can increase or decrease. By applying a voltage V and a current I to the tissue, the impedance Z of the tissue can be determined at various compression levels.

[0103] The anvil (400) may include a plurality of staple pit sensors (804), each staple pit sensor (804) positioned within one of the staple forming pits (414, 510, 550). The staple pit sensors (804) may be configured to be able to detect contact of staples (90), generate a signal including information from one or more of the plurality of staple pit sensors (804), and send the generated signal to a processor (704) for processing such that the signal can be sent to an anvil transceiver (706) to be relayed to a handle transceiver (604).

[0104] Figure 16Component diagram of an exemplary intelligent anvil (400) according to one aspect of the present disclosure. As shown, the anvil (400) may include a processor (704), a memory (708), and an anvil transceiver (706). The anvil transceiver (706) and the handle transceiver (604) may be compatible with one or more of radio frequency identification (RFID), near field communication (NFC), BluetoothTM, Bluetooth Low EnergyTM (BLE), WiFi, or similar technologies. In some examples, different components may have different frequencies for different purposes. For example, in one example, the anvil transceiver (706) is capable of transmitting signals at a first frequency, and the handle transceiver (604) is capable of transmitting signals at a different second frequency. The anvil transceiver (706) may generate a lower signal frequency and transmit it to the handle transceiver (604) so that the signal can more easily pass through the patient's tissue; the handle transceiver (604) is capable of generating and transmitting a higher signal frequency because (i) it does not attempt to pass through the patient tissue, and (ii) it can have a frequency dedicated to its communication with the external hub (902) and different from the anvil frequency to reduce interference.

[0105] The processor (704) may include one or more of a microprocessor, a microcontroller, a digital signal processor, a coprocessor, etc. or a combination thereof capable of executing stored instructions and operating on stored data. In some specific implementations, the memory (708) may include one or more appropriate types of memory (e.g., such as volatile or non-volatile memory, random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, etc.) for storing files including an operating system, application programs, executable instructions, and data. In one implementation, the processing techniques described herein may be implemented as a combination of executable instructions and data stored in the memory (708). The memory (708) may include instructions that, when executed by the processor (704), execute one or more processes consistent with the functions disclosed herein. The methods, systems, and articles of manufacture consistent with the disclosed implementations are not limited to separate programs or computers configured to be capable of performing dedicated tasks. For example, the anvil (400) may include a memory (708) that may include one or more programs that execute one or more functions of the disclosed implementations.

[0106] Figure 17depicts a system environment for an exemplary circular stapler (10) and an external hub (902) in accordance with one aspect of the present disclosure. The handle controller (602) may include a processor (904) that may be substantially similar to the processor (704). The handle controller (602) may include a memory (906) that may be substantially similar to the memory (708). As described above, the external hub (902) may include an external computing system having a display for providing information received from within the occlusion (900). The external hub (902) may be located many feet away from the circular stapler (10), and the occlusion may prevent signals from reaching the hub (902) because the patient's tissue can obstruct the signals within the normal operating distance of such devices (e.g., for Bluetooth TM or Wi-Fi TM at approximately 2.4 GHz). Figure 18 is an exemplary schematic diagram of a smart circular stapler (10) in use. The smart circular stapler also identifies how the anvil transceiver (706) is positioned within the occlusion (900) (i.e., the patient's abdomen), how the handle transceiver (604) is positioned outside the occlusion (900), and how the external hub (902) is positioned distal to the handle transceiver (604) and the circular stapler (10). As described above, the external hub (902) may include an external computing system having a display for providing information received from within the occlusion (900). In some examples, the external hub (902) may be a component of a robotic system, and the circular stapler (10) may be an attachment to the robotic system.

[0107] The techniques described herein may also be implemented by any of the following numbered clauses:

[0108] Clause 1: A device, the device comprising: (A) a stapling head assembly (300); (B) an anvil (400) that is removably attachable to the stapling head assembly (300); and (C) a handle assembly (100) that includes: a handle controller (602); a connector (606); and a handle transceiver (604) configured to wirelessly transmit a first signal to an external hub (902), wherein the handle transceiver (604) is separated from the handle controller (602) and is in electrical communication with the handle controller (602) via the connector (606).

[0109] Clause 2: The device according to clause 1, wherein the handle assembly (100) includes a knob (130) that is rotatable to adjust a gap distance between an anvil surface (412) and the handle assembly (100), wherein the handle transceiver (604) is positioned within the knob (130).

[0110] Clause 3: The apparatus according to Clause 1, wherein the handle assembly (100) includes a pistol grip (112), and wherein the handle transceiver (604) is positioned within the pistol grip (112).

[0111] Clause 4: The apparatus according to Clause 3, wherein the handle transceiver (604) is encapsulated within a shield (612) to protect the handle transceiver (604) from signal noise from the motor (160).

[0112] Clause 5: The apparatus according to Clause 1, wherein the handle assembly (100) includes: a battery housing (608) that includes a battery (122); and a housing cavity (610) sized to receive the battery housing (608), wherein the battery housing (608) is insertable into and removable from the housing cavity (610), and wherein the handle transceiver (604) is positioned on the battery housing (608).

[0113] Clause 6: The apparatus according to Clause 5, wherein the handle assembly (100) includes: a first connector (614) positioned on the battery housing (608) and in electrical communication with the handle transceiver (604); and a second connector (616) positioned within the housing cavity (610) and in electrical communication with the handle controller (602), wherein the first connector (614) and the second connector (616) are configured to contact each other when the battery housing (608) is positioned within the housing cavity (610).

[0114] Clause 7: The apparatus according to Clause 1, wherein the handle assembly (100) includes: a battery housing (608) that includes a battery (122); and a housing cavity (610) sized to receive the battery housing (608), wherein the battery housing (608) is insertable into and removable from the housing cavity (610), and wherein the handle transceiver (604) is positioned within the housing cavity (610).

[0115] Clause 8: The apparatus according to Clause 1, wherein the handle assembly (100) includes a display (620) positioned on a display panel (620) visible from the exterior of the handle assembly (100), wherein the handle transceiver (604) is positioned on the display panel (620).

[0116] Clause 9: The device according to Clause 1, wherein the anvil (400) is removably attached to the suture head assembly (300) and includes one or more sensors (802, 804, 712) configured to output a signal to the handle controller (602).

[0117] Clause 10: The device according to Clause 9, wherein: the anvil (400) includes an anvil transceiver (706); the one or more sensors (802, 804, 712) are configured to generate a second signal including first sensor data; the one or more sensors (802, 804, 712) are configured to send the first signal to the anvil transceiver (706); and the handle transceiver (604) is configured to communicate wirelessly with the anvil transceiver (706) and to operate as a wireless repeater between the anvil transceiver (706) and the external hub (902).

[0118] Clause 11: A device, the device comprising: (A) a suture head assembly (300), the suture head assembly including: a platform surface (322); a staple opening array (324) formed through the platform surface (322); a plurality of staples (90) associated with the staple opening array (324), wherein the suture head assembly (300) is operable to drive the staples (90) through the staple opening array (324); (B) an anvil (400), the anvil being removably attachable to the suture head assembly (300) and including: an anvil surface (412) configured to compress tissue against the platform surface (322), wherein the anvil surface (412) defines an array of staple forming pits (414, 510, 550); an anvil power supply (702); and an anvil transceiver (706); and (C) a handle assembly (100), the handle assembly including: a handle controller (602); and a handle transceiver (604) configured to communicate wirelessly with both the anvil transceiver (706) and an external hub (902), and wherein the handle transceiver (604) is operable as a wireless repeater to receive a first signal from the anvil transceiver (706) and send a second signal to the external hub (902).

[0119] Clause 12: The device according to Clause 11, wherein the anvil (400) further includes a position sensor (712) operable to detect the orientation of the anvil (400) within a patient, and wherein the first signal includes information related to the orientation of the anvil (400).

[0120] Clause 13: The apparatus according to Clause 11, wherein the anvil (400) further includes a surface sensor (802) positioned on the anvil surface (412), wherein the surface sensor (802) is operative to detect contact of tissue on the anvil surface (412), and wherein the first signal includes information related to the contact.

[0121] Clause 14: The apparatus according to Clause 13, wherein the surface sensor (802) is one of a plurality of surface sensors, and wherein the plurality of surface sensors are configured to be able to detect compression of tissue between the anvil surface (412) and the platform surface (322).

[0122] Clause 15: The apparatus according to Clause 11, wherein the anvil (400) further includes a plurality of staple pit sensors (804), each staple pit sensor (804) being positioned within one of the staple forming pits (414, 510, 550) and being configured to be able to detect contact with a staple (90), and wherein the first signal includes information from one or more of the plurality of staple pit sensors (804).

[0123] Clause 16: The apparatus according to Clause 11, wherein the handle assembly (100) includes a knob (130) that is rotatable to adjust the gap distance between the anvil surface (412) and the platform surface (322), and wherein the handle transceiver (604) is positioned within the knob (130).

[0124] Clause 17: The apparatus according to Clause 11, wherein the handle assembly (100) includes a pistol grip (112), and wherein the handle transceiver (604) is positioned within the pistol grip (112).

[0125] Clause 18: The apparatus according to Clause 17, wherein the handle transceiver (604) is encapsulated within a shield (612) to protect the handle transceiver (604) from signal noise from the motor (160).

[0126] Clause 19: The apparatus according to Clause 11, wherein the handle assembly (100) includes: a battery housing (608) that includes a battery (122); and a housing cavity (610) sized to receive the battery housing (608), wherein the battery housing (608) is insertable into and removable from the housing cavity, and wherein the handle transceiver (604) is positioned on the battery housing (608).

[0127] Clause 20: The apparatus according to Clause 19, wherein the handle assembly (100) includes: a first connector (614) positioned on the battery housing (608) and in electrical communication with the handle transceiver (604); and a second connector (616) positioned within the housing cavity (610) and in electrical communication with the handle controller (602), wherein the first connector (614) and the second connector (616) are configured to be in contact with each other when the battery housing (608) is positioned within the housing cavity (610).

[0128] Clause 21: The apparatus according to Clause 11, wherein the handle assembly (100) includes: a battery housing (608) including a battery (122); and a housing cavity (610) sized to receive the battery housing (608), wherein the battery housing (608) is insertable into and removable from the housing cavity (610), and wherein the handle transceiver (604) is positioned within the housing cavity (610).

[0129] Clause 22: The apparatus according to Clause 11, wherein the handle assembly (100) includes a display (620) positioned on a display panel (620) visible from the exterior of the handle assembly (100), wherein the handle transceiver (604) is positioned on the display panel (620).

[0130] Clause 23: The apparatus according to Clause 11, wherein the first signal and the second signal are transmitted at different frequencies.

[0131] Clause 24: An apparatus, the apparatus including: (A) a suture head assembly (300); (B) an anvil (400) removably attachable to the suture head assembly (300) and including an anvil transceiver (706) and one or more sensors (802, 804, 712) configured to generate a first signal including first sensor data and transmit the first signal to the anvil transceiver (706) for transmission by the anvil transceiver (706); and (C) a handle assembly (100) including: a handle controller (602); and a handle transceiver (604) configured to wirelessly communicate with the anvil transceiver (706) and receive the first signal.

[0132] Clause 25: The apparatus of clause 24, wherein the handle transceiver (604) is operable as a wireless repeater to receive a first signal from the anvil transceiver (706) and to send a second signal to an external hub (902).

[0133] Clause 26: The device of clause 25, wherein the second signal comprises the first sensor data.

[0134] Clause 27: The apparatus of clause 25, wherein the first signal and the second signal are transmitted at different frequencies.

[0135] Clause 28: The apparatus of clause 24, wherein the one or more sensors (802, 804, 712) include a position sensor (712) operable to detect an orientation of the anvil (400) within the patient's body, and wherein the first sensor data includes information related to the orientation of the anvil (400).

[0136] Item 29: The apparatus of Item 24, wherein the handle assembly (100) comprises: a battery housing (608) comprising a battery (122); and a housing cavity (610) sized to receive the battery housing (608), wherein the battery housing (608) is insertable into and removable from the housing cavity (610), and wherein the handle transceiver (604) is positioned on the battery housing (608).

[0137] Clause 30: The apparatus of clause 24, wherein the handle assembly (100) comprises a display (620) positioned on a display panel (620) visible from outside the handle assembly (100), wherein the handle transceiver (604) is positioned on the display panel (620).

[0138] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

[0139] The present invention need not be limited to the examples described, and the configurations and details of these examples may vary. The terms "distal" and "proximal" are used throughout the foregoing description and refer to the position and orientation relative to the physician or user holding the circular stapler 10. Similarly, "distal" or "distally" refers to a position away from the person holding the circular stapler 10 or in a direction away from that person. Similarly, "proximal" or "proximally" refers to a position near the person grasping the pistol grip 112 (i.e., toward the operator of the circular stapler 10) or in a direction toward the person grasping the pistol grip. Further, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. Additionally, the use of the phrases "coupled", "coupling", or the like should not be construed as limited to a certain number of components or a particular order of components, unless the context clearly dictates otherwise.

[0140] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of ±10% of the recited value, e.g., "about 90%" can refer to a range of values from 80.001% to 99.999%.

[0141] In describing example embodiments, terms are employed for clarity. Accordingly, all possible combinations are not listed, and such variations are generally obvious to those skilled in the art and are intended to fall within the scope of the following claims. Without departing from the scope and spirit of the present invention, each term is intended to be construed in its broadest sense as understood by those skilled in the art and to include all technical equivalents that operate in a similar manner to achieve a similar purpose. It should also be understood that the recitation of one or more steps of a method does not preclude the presence of additional method steps or intermediate method steps between those expressly identified. Similarly, some steps of a method may be performed in an order different from that described herein without departing from the scope of the disclosed technology.

Claims

1. A device, comprising: (A) Suture head assembly; (B) an anvil removably attachable to the stapling head assembly; and (C) a handle assembly, the handle assembly comprising: Handle controller; Connectors; and A handle transceiver is configured to wirelessly transmit a first signal to an external hub, wherein the handle transceiver is separate from the handle controller and is in electrical communication with the handle controller via the connector.

2. The device according to claim 1, wherein: The handle assembly includes a knob rotatable to adjust a gap distance between an anvil surface and the handle assembly, wherein the handle transceiver is positioned within the knob.

3. The device according to claim 1, wherein: The handle assembly includes a pistol grip, and wherein the handle transceiver is positioned within the pistol grip.

4. The device according to claim 3, wherein: The handle transceiver is enclosed in a shroud to protect the handle transceiver from signal noise from the motor.

5. The device according to claim 1, wherein: The handle assembly comprises: a battery housing, the battery housing comprising a battery; and a housing cavity sized to receive the battery housing, wherein the battery housing is insertable into and removable from the housing cavity, and Wherein, the handle transceiver is positioned on the battery housing.

6. The device according to claim 5, wherein: The handle assembly comprises: a first connector positioned on the battery housing and in electrical communication with the handle transceiver; and a second connector positioned within the housing cavity and in electrical communication with the handle controller, Wherein, the first connector and the second connector are configured to be able to contact each other when the battery housing is positioned in the housing cavity.

7. The device according to claim 1, wherein: The handle assembly comprises: a battery housing, the battery housing comprising a battery; and a housing cavity sized to receive the battery housing, wherein the battery housing is insertable into and removable from the housing cavity, and Wherein, the handle transceiver is positioned within the housing cavity.

8. The device according to claim 1, wherein: The handle assembly includes a display positioned on a display panel visible from an exterior of the handle assembly, wherein the handle transceiver is positioned on the display panel.

9. The device according to claim 1, wherein: The anvil is removably attached to the stapling head assembly and includes one or more sensors configured to output signals to the handle controller.

10. The apparatus of claim 9, wherein: The anvil includes an anvil transceiver; The one or more sensors are configured to generate a second signal including the first sensor data; The one or more sensors are configured to transmit the first signal to the anvil transceiver; and The handle transceiver is configured to communicate wirelessly with the anvil transceiver and is operable as a wireless repeater between the anvil transceiver and the external hub.

11. A device, comprising: (A) A suturing head assembly, the suturing head assembly comprising: Platform surface; an array of nail openings formed through the platform surface; a plurality of staples associated with the array of staple openings, wherein the stapling head assembly is operable to drive the staples through the array of staple openings; (B) an anvil removably attachable to the stapling head assembly and comprising: an anvil surface configured to compress tissue against the deck surface, wherein the anvil surface defines an array of staple forming pockets; anvil power supply; and anvil transceiver; and (C) a handle assembly, the handle assembly comprising: a handle controller; and A handle transceiver is configured to wirelessly communicate with both the anvil transceiver and an external hub, and wherein the handle transceiver is operable as a wireless repeater to receive a first signal from the anvil transceiver and send a second signal to the external hub.

12. The device according to claim 11, wherein The anvil further comprises a position sensor operable to detect an orientation of the anvil within the patient, and wherein the first signal comprises information relating to the orientation of the anvil.

13. The device according to claim 11, wherein: The anvil further includes a surface sensor positioned on the anvil surface, wherein the surface sensor is operable to detect contact of tissue on the anvil surface, and wherein the first signal includes information related to the contact.

14. The device according to claim 13, wherein: The surface sensor is one of a plurality of surface sensors, and wherein the plurality of surface sensors are configured to detect compression of tissue between the anvil surface and the deck surface.

15. The apparatus according to claim 11, wherein: The anvil also includes a plurality of nail pit sensors, each nail pit sensor being positioned within one of the nail forming pits and configured to detect contact with a nail, and wherein the first signal includes information from one or more nail pit sensors of the plurality of nail pit sensors.

16. The apparatus according to claim 11, wherein: The handle assembly includes a knob rotatable to adjust a gap distance between an anvil surface and the deck surface, wherein the handle transceiver is positioned within the knob.

17. The apparatus according to claim 11, wherein: The handle assembly includes a pistol grip, and wherein the handle transceiver is positioned within the pistol grip.

18. The apparatus according to claim 17, wherein: The handle transceiver is enclosed in a shroud to protect the handle transceiver from signal noise from the motor.

19. The apparatus according to claim 11, wherein: The handle assembly comprises: a battery housing, the battery housing comprising a battery; and a housing cavity sized to receive the battery housing, wherein the battery housing is insertable and removable from the housing cavity, and Wherein, the handle transceiver is positioned on the battery housing.

20. The apparatus of claim 19, wherein: The handle assembly comprises: a first connector positioned on the battery housing and in electrical communication with the handle transceiver; and a second connector positioned within the housing cavity and in electrical communication with the handle controller, Wherein, the first connector and the second connector are configured to be able to contact each other when the battery housing is positioned in the housing cavity.

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