WO2025177198A1

WO2025177198A1 - Compression anastomosis device with in vivo electrical stimulation

Info

Publication number: WO2025177198A1
Application number: PCT/IB2025/051826
Authority: WO
Inventors: Alexander W. CAULK; David A. Nicholas; Brian L. HOLDEN; Monideepa Chatterjee
Original assignee: Covidien LP
Current assignee: Covidien LP
Priority date: 2024-02-23
Filing date: 2025-02-20
Publication date: 2025-08-28
Anticipated expiration: 2026-08-23

Abstract

An electrical stimulation compression ring device includes a first ring for engaging a first segment of an alimentary tract portion and a second ring for engaging a second segment of the alimentary tract portion. One or both of the first ring or the second ring are movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring. One or both of the first ring or the second ring includes an electrical stimulation circuit for generating an electrical stimulation signal and one or more electrodes disposed on an anastomosis-contacting surface. The electrode(s) are used for delivering the electrical stimulation signal to the anastomosis.

Description

COMPRESSION ANASTOMOSIS DEVICE WITH IN VIVO ELECTRICAL STIMULATION

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/556,911, filed February 23, 2024, which is incorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

[0002] The present disclosure relates to surgical devices. More specifically, the present disclosure relates to compression anastomosis device for forming an anastomosis via compression between two rings, where one or both rings include in vivo electrical stimulation to enhance healing of the formed anastomosis.

2. Background of Related Art

[0003] In the event that some portion of the alimentary tract is removed, and continuity needs to be restored with an anastomosis, surgeons currently use surgical staplers or handsewn sutures to create the anastomosis. However, such techniques may result in certain complications, e.g., malformed staples. Thus, there is a need for a surgical device configured to form anastomoses of the alimentary canal using alternative fastening methods.

SUMMARY

[0004] The present disclosure provides an anastomosis forming device that accounts for differences in tissue properties by adjusting the compression gap according to an internal feedback mechanism. In particular, a powered surgical anastomosis device is provided that is configured to clamp, compress, and lock a compression ring device to form an anastomosis. The compression ring device includes two opposing rings configured to connect two sections of an alimentary tract (e.g., intestine, colon, etc.). The powered surgical device includes a handle assembly having a power source and one or more motors coupled to the power source. The device also includes an adapter assembly having multiple transmission assemblies, e.g., drive shafts, which transmit actuation from the powered handle. The powered handle assembly and the adapter assembly may be reusable. The adapter assembly includes an end effector having an anvil and a reload configured to engage the compression ring device to move the two rings together. The end effector also includes compression and locking actuation mechanisms to secure the compression ring device to the alimentary tract thereby forming the anastomosis. The end effector also includes a cutting mechanism, i.e., an annular cutter, to restore the lumen of the alimentary tract.

[0005] The powered surgical device operates in four phases, namely, compressing, locking, cutting, and unclamping. Clamping is accomplished by moving the anvil in a proximal direction to compress tissue held within the compression ring device and/or moving a portion of the reload in a distal direction. During compression, the rings are further approximated until a desired compression pressure is reached. Locking is accomplished by securing the rings of the compression ring device at the compressed distance. The lumen of the tissue is restored by advancing a circular knife to cut tissue from the center of the rings during the cutting phase. During unclamping, the anvil is disengaged from the compression ring device and is retracted, allowing for removal of the powered surgical device from the alimentary tract.

[0006] The compression ring device includes a pair of opposing compression rings that are used to form the anastomosis. The compression rings may advantageously provide 1) more uniform distribution of pressure across tissue, 2) a reduced number of puncture sites to the tissue (i.e., few locking pins for the compression device vs. multiple staples), and 3) an adjustable compression gap based on real-time feedback indicators. In addition, the compression ring device also optimizes tissue compression pressure, and depending on data collected compression speed may be optimized for various tissue types and health conditions. Real-time feedback may include data from one or more sensors such as strain gauges for force, light absorption detectors for optical properties, bioimpedance sensors for electrical properties, or other similar sensors. Such feedback provides the opportunity to evaluate real-time changes to tissue properties during the compression phase of the anastomosis such that the compression gap may be prescribed by the system to optimize these target properties. This allows for tailoring of the compression based on different tissue loads for similar compression values. In addition, using the feedback during compression of the compression ring also reduces the chances of mechanical failure of the tissue since tissue properties, i.e., failure properties, depend upon compression. This is also an added advantage of the feedback loop and adjustable compression profile. In particular, optical and electrical properties change with tissue compression, allowing for sensing and compression optimization using various tissue properties which can inform clinically relevant metrics such as structural tissue damage, tissue perfusion, etc.

[0007] For device operation, the compression ring device including two rings is inserted into the tissue of interest using the powered surgical device. A first, e.g., distal, ring (i.e., the ring farther from the handle assembly), may be retracted toward a second, e.g., proximal, ring (i.e., the ring closer to the handle assembly). In embodiments, the second ring may be advanced toward the first ring. Rings may be advanced using one or more motors and a drive assembly until a feedback mechanism dictates that the compression is sufficient based on real-time feedback indicator (e.g., force), at which point the first ring is fixed in place. Each of the rings may be advanced by their corresponding mechanisms, e.g., motors and transmission assemblies. A separate driver may then be advanced to move a lock ring to lock the rings with the appropriate gap and ensure proper fixation of the rings to the tissue.

[0008] In embodiments, the first ring may remain stationary following calibration and the second ring is advanced distally to compress the tissue. A lock ring is then advanced with a separate motor. This two-step (i.e., compress and lock) approach ensures that the tissue compression force measurement is accurate and does not contain the force required to advance the lock ring. In further embodiments, the second ring may remain stationary and the first ring is advanced proximally to compress tissue. The lock ring is similarly advanced to lock the rings in place. In yet further embodiments, both rings may be approximated to compress tissue, followed by moving the lock ring.

[0009] In embodiments, other locking mechanisms may be used, such as locking pins, which are advanced through both compression rings to lock the rings with the appropriate gap and ensure proper fixation of the rings to the tissue. Similar to currently available circular staplers, compression rings could be manufactured with a variety of diameters and materials, e.g., bioabsorbable, to accommodate different lumen sizes in the clinical population.

[0010] Anastomotic leaks remain a persistent problem in various surgical applications. Electrical stimulation of tissue may be used to accelerate collagen deposition and improve wound healing metrics in other contexts (e.g., excisional dermal wounds). Mechanical, optical, and electrical properties of the tissue at the site of the anastomosis change following transection and application of voltage or current accelerates the regeneration of the tissue to its homeostatic values and improve standard metrics of wound healing (e.g., collagen deposition, anastomotic burst strength, etc.).

[0011] The present disclosure provides a compression ring device including a first ring and a second ring that are compressed to form an anastomosis. While this disclosure primarily describes the use of the compression ring device in colorectal procedures, it is envisioned that this device may be also used in bariatric as well as thoracic (e.g., esophageal) surgery.

[0012] One or both rings may have optical and/or electrical sensors and an electrical stimulator to provide real-time adjustments based on tissue properties measured by the sensors. Optimization of tissue properties during wound healing can accelerate the wound healing process and reduce postoperative adverse outcomes such as anastomotic leaks. One or both rings may also include a voltage or current applicator that adjusts electrical stimulation based on real-time feedback from any combination of in vivo force, optical, and/or electrical sensing data. Electrical stimulation can be adjusted to maintain or alter tissue electrical properties after the surgery is complete. The rings may also include a wireless communication device for communicating to an external device (e.g., smart phone or tablet). In other embodiments, the connection between the rings and the external device may be wired, with the wires protruding from the skin post-surgery to enable wired control of the rings. Adjustment of impedance may be programmed algorithmically or tailored manually by the external device and/or by a clinician (e.g., surgeon, nurse, etc.). The sensor readouts from the rings provide an indicator regarding healing status, and the clinician may then override the built-in algorithmic control to adjust electrical stimulation parameters within a predefined range (e.g., ranging from turning off the electrical stimulation to some maximum current or voltage).

[0013] Suitable electrical stimulation signals may be rectified AC signals at a frequency of about 10-15 MHz with the voltage oscillating between 0 and 5 V. Application of stimulating energy may last from about 1 day to about 14 days and may last from about 1 hour to about 24 hours daily, and in embodiments from about 2 hours to about 8 hours daily. These parameters may be altered based on the specific needs of the tissue. For example, stimulation may be required throughout the duration of the implant to ensure proper healing. Similarly, the electrical stimulation frequency may be constant throughout therapy or adjusted based on measured tissue parameters to allow the tissue to reach the desired impedance value and achieve optimal wound closure. [0014] According to one embodiment of the present disclosure, an electrical stimulation compression ring device is disclosed. The electrical stimulation compression ring device includes a first ring for engaging a first segment of an alimentary tract portion and a second ring for engaging a second segment of the alimentary tract portion. One or both of the first ring or the second ring are movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring. One or both of the first ring or the second ring includes an electrical stimulation circuit for generating an electrical stimulation signal and one or more electrodes disposed on an anastomosis-contacting surface. The electrode(s) are used for delivering the electrical stimulation signal to the anastomosis.

[0015] Implementations of the above embodiment may include one or more of the following features. According to one aspect of the above embodiment, the electrode(s) may include a first electrode and a second electrode. The first electrode and the second electrode may be disposed on one of the first ring or the second ring. The first electrode may be disposed on the first ring and the second electrode may be disposed on the second ring. The electrical stimulation circuit may include a battery and a stimulation signal generator for converting direct current from the battery to generate the electrical stimulation signal. The electrical stimulation signal may be an alternating current signal. The electrical stimulation compression ring device may also include a memory storing a stimulation signal delivery algorithm and a controller for controlling the stimulation signal generator using the stimulation signal delivery algorithm. The electrical stimulation compression ring device may further include a sensor for measuring a property of the anastomosis. The controller may control the stimulation signal generator based on the measured property of the anastomosis.

[0016] According to another embodiment of the present disclosure, an electrical stimulation system is disclosed. The electrical stimulation system includes an electrical stimulation compression ring device having a first ring for engaging a first segment of an alimentary tract portion and a second ring for engaging a second segment of the alimentary tract portion. One or both of the first ring or the second ring are movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring. One or both of the first ring or the second ring includes an electrical stimulation circuit for generating an electrical stimulation signal and one or more electrodes disposed on an anastomosiscontacting surface. The electrode(s) are used for delivering the electrical stimulation signal to the anastomosis. The system also includes an external control device in communication with the electrical stimulation compression ring device. The external control device controls delivery of the electrical stimulation signal to the anastomosis.

[0017] Implementations of the above embodiment may include one or more of the following features. According to one aspect of the above embodiment, the electrode(s) may include a first electrode and a second electrode. The first electrode and the second electrode may be disposed on one of the first ring or the second ring. The first electrode may be disposed on the first ring and the second electrode may be disposed on the second ring. The electrical stimulation circuit may include a battery and a stimulation signal generator for converting direct current from the battery to generate the electrical stimulation signal. The electrical stimulation signal may be an alternating current signal. The electrical stimulation compression ring device may also include a memory storing a stimulation signal delivery algorithm and a controller for controlling the stimulation signal generator using the stimulation signal delivery algorithm. The electrical stimulation compression ring device may further include a sensor for measuring a property of the anastomosis. The controller may control the stimulation signal generator based on the measured property of the anastomosis. The external control device may include user input means for receiving user input to select at least one parameter of the delivery of the electrical stimulation signal to the anastomosis. The parameter may be duration or frequency of the delivery of the electrical stimulation signal to the anastomosis. The parameter may be an energy parameter of the electrical stimulation signal.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:

[0019] FIG. 1 is a perspective view of a powered surgical device including a handle assembly, an adapter assembly, and an end effector, according to an embodiment of the present disclosure;

[0020] FIG. 2 is a schematic diagram of the handle assembly, the adapter assembly, and the end effector of FIG. 1 ;

[0021] FIG. 3 is a side perspective view of the adapter assembly and the end effector attached to the adapter assembly of FIG. 1 according to an embodiment of the present disclosure; [0022] FIG. 4 is a perspective view of a first transmission assembly disposed within the adapter assembly of FIG. 1, shown partially in phantom;

[0023] FIG. 5 is a perspective view of a second transmission assembly disposed within the adapter assembly of FIG. 1, shown partially in phantom;

[0024] FIG. 6 is a perspective view of a third transmission assembly disposed within the adapter assembly of FIG. 1, shown partially in phantom;

[0025] FIG. 7 is a perspective view of an end effector including an anvil assembly and a reload for deploying a compression ring device according to one embodiment of the present disclosure;

[0026] FIG. 8 is a side, cross-sectional view of the anvil assembly separated from the reload of FIG. 7;

[0027] FIG. 9 is a perspective view with parts separated of the anvil assembly of FIG. 7;

[0028] FIG. 10 is a perspective view with parts separated of the reload of FIG. 7;

[0029] FIG. 11 is a front, perspective view of a second ring of the compression ring device of FIG. 7;

[0030] FIG. 12 is a rear perspective view of the second ring of the compression ring device of FIG. 7;

[0031] FIG. 13 is a perspective view of the anvil assembly in inside a first alimentary tract portion and the end effector in a second alimentary tract portion according to an embodiment of the present disclosure;

[0032] FIG. 14 is a perspective view of the anvil assembly coupled to the end effector joining two alimentary tract portions according to an embodiment of the present disclosure;

[0033] FIG. 15 is a side view of the end effector with the compression ring device in a clamped configuration inside the alimentary tract portion according to an embodiment of the present disclosure;

[0034] FIG. 16 is a side, cross-sectional view of the end effector with the compression ring device in a clamped configuration inside the alimentary tract portion according to an embodiment of the present disclosure;

[0035] FIG. 17 is a side, cross-sectional view of the end effector with the compression ring device in the clamped configuration and a deployed knife assembly inside the alimentary tract portion according to an embodiment of the present disclosure; [0036] FIG. 18 is a side, cross-sectional view of the compression ring device in the clamped configuration inside the alimentary tract portion according to an embodiment of the present disclosure;

[0037] FIG. 19 is a perspective view of the compression ring device in the clamped configuration inside the alimentary tract portion according to an embodiment of the present disclosure;

[0038] FIG. 20 shows a perspective view of an electrical stimulation compression ring device according to an embodiment of the present disclosure;

[0039] FIG. 21 shows a perspective, rear view of a ring of an electrical stimulation compression ring device according to another embodiment of the present disclosure;

[0040] FIG. 22 is a perspective view of the electrical stimulation compression ring device disposed about an anastomosis formed in an alimentary tract portion according to an embodiment of the present disclosure;

[0041] FIG. 23 is a perspective, partially transparent view of the electrical stimulation compression ring device disposed about an anastomosis formed in an alimentary tract portion according to an embodiment of the present disclosure;

[0042] FIG. 24 is a perspective view of a patient having an external control device for communicating with the electrical stimulation compression ring device according to an embodiment of the present disclosure;

[0043] FIG. 25 is a plan view of a printed circuit board disposed inside a first ring and/or a second ring of the electrical stimulation compression ring device according to an embodiment of the present disclosure;

[0044] FIG. 26 is a schematic diagram of an electrical stimulation system including the electrical stimulation compression ring device and the external control device the according to an embodiment of the present disclosure; and

[0045] FIG. 27 shows a flow chart of a method for providing electrical stimulation to an anastomosis site according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

[0046] Embodiments of the presently disclosed surgical devices, and adapter assemblies for surgical devices and/or handle assemblies 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 used herein the term “distal” refers to that portion of the surgical instrument, or component thereof, farther from the user, while the term “proximal” refers to that portion of the surgical instrument, or component thereof, closer to the user.

[0047] As used herein, the terms “biodegradable” and “bioabsorbable” are used with respect to a property of a material. “Biodegradable” is a material that is capable of being decomposed or broken down in vivo and subsequently excreted. “Bioabsorbable” is a material that is capable of being decomposed or broken down in vivo and subsequently resorbed. Both biodegradable and bioabsorbable materials are suitable for purposes of this application and thus for simplicity, unless otherwise directed, biodegradable materials and bioabsorbable materials are collectively referred to as “biodegradable” herein. Conversely, “non-biodegradable” is a biocompatible (i.e., not harmful to living tissue) material is not decomposed or broken down in vivo. In addition, the term “dissolution” as used in the description refers to the breakdown of both biodegradable and bioabsorbable materials.

[0048] FIG. 1 illustrates a surgical device, such as, for example, a powered surgical device

10 for forming end-to-end anastomosis (“EEA”), including a handle assembly 100, which is configured for selective connection with an adapter assembly 200. The adapter assembly 200 is configured for selective connection with an end effector 600, which includes an annular reload 700 and an anvil assembly 800 (FIG. 7). The end effector 600 is configured to produce a surgical effect on tissue of a patient, namely, forming an anastomosis by connecting two portions of alimentary tract portion (e.g., intestine, colon, etc.).

[0049] The handle assembly 100 includes a power handle 101 and an outer shell housing

11 configured to selectively receive and encase power handle 101. The shell housing 11 includes a distal half-section I la and a proximal half-section 11b pivotably connected to distal half-section I la. When joined, distal and proximal half-sections I la, 11b define a shell cavity therein in which power handle 101 is disposed.

[0050] While the powered surgical device 10 is described herein as a modular device including a plurality of interconnected components, such as the handle assembly 100, the removable shell housing 11, and the adapter assembly 200, etc. The powered surgical device 10 may be formed as an integrated device with one or more of the components being securely attached to each other, e.g., during manufacturing of the powered surgical device. [0051] Distal and proximal half-sections I la, 1 lb of shell housing 11 are divided along a plane that traverses a longitudinal axis of adapter assembly 200. Distal half-section 1 la of shell housing 11 defines a connecting portion 20 configured to accept a corresponding drive coupling assembly 210 (FIG. 3) of adapter assembly 200. Distal half-section I la of shell housing 11 supports a toggle control button 30. Toggle control button 30 is capable of being actuated in four directions (i.e., a left, right, up, and down).

[0052] With reference to FIG. 2, the power handle 101 includes a main controller circuit board 142, a rechargeable battery 144 configured to supply power to any of the electrical components of handle assembly 100, and a plurality of motors, i.e., a first motor 152a, a second motor 152b, a third motor 152c, coupled to the battery 144. The power handle 101 also includes a display 146. In embodiments, the motors 152a, 152b, 152c may be coupled to any suitable power source configured to provide electrical energy to the motors 152a, 152b, 152c, such as an AC/DC transformer. Each of the motors 152a, 152b, 152c is coupled to a motor controller 143 which controls the operation of the corresponding motors 152a, 152b, 152c including the flow of electrical energy from the battery 144 to the motors 152a, 152b, 152c. A main controller 147 controls the power handle 101 and is configured to execute software instructions embodying algorithms disclosed herein, such as clamping, compressing, locking, and cutting algorithms which control operation of the power handle 101.

[0053] The motor controller 143 includes a plurality of sensors 408a ... 408n, where “n” can be any number of sensors configured to measure operational states of the motors 152a, 152b, 152c and the battery 144. The sensors 408a-n include a strain gauge 408b and may also include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n may measure voltage, current, and other electrical properties of the electrical energy supplied by the battery 144. The sensors 408a-408n may also measure angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operational properties of the motors 152a, 152b, 152c. The sensor 408a also includes an encoder configured to count revolutions or other indicators of the motors 152a, 152b, 152c, which is then use by the main controller 147 to calculate linear movement of components movable by the motors 152a, 152b, 152c. Angular velocity may be determined by measuring the rotation of the motors 152a, 152b, 152c or a drive shaft (not shown) coupled thereto and rotatable by the motors 152a, 152b, 152c. The position of axially movable drive shafts may also be determined by using linear sensors disposed in or in proximity to the shafts or extrapolated from the RPM measurements. In embodiments, torque may be calculated based on the regulated current draw of the motors 152a, 152b, 152c at a constant RPM. In further embodiments, the motor controller 143 and/or the main controller 147 may measure time and process the above- described values as a function of time, including integration and/or differentiation, e.g., to determine the rate of change in the measured values. The main controller 147 is also configured to determine distance traveled of components of the adapter assembly 200 and/or the end effector 600 by counting revolutions of the motors 152a, 152b, 152c.

[0054] The motor controller 143 is coupled to the main controller 147, which includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 147 receives measured sensor signals from the motor controller 143 regarding operational status of the motors 152a, 152b, 152c and the battery 144 and, in turn, outputs control signals to the motor controller 143 to control the operation of the motors 152a, 152b, 152c based on the sensor readings and specific algorithm instructions. The main controller 147 is also configured to accept a plurality of user inputs from a user interface (e.g., switches, buttons, touch screen, etc. coupled to the main controller 147). The main controller 147 is also configured to receive optical and electrical sensor signals from sensors embedded in the reload 700.

[0055] The main controller 147 is also coupled to a memory 141. The memory 141 may include volatile (e.g., RAM) and non-volatile storage configured to store data, including software instructions for operating the power handle 101. The main controller 147 is also coupled to the strain gauge 408b of the adapter assembly 200 using a wired or a wireless connection and is configured to receive strain measurements from the strain gauge 408b which are used during operation of the power handle 101.

[0056] Turning now to FIG. 3, adapter assembly 200 includes an outer knob housing 202 and an outer tube 206 extending from a distal end of knob housing 202. Knob housing 202 and outer tube 206 are configured and dimensioned to house the components of adapter assembly 200. The knob housing 202 includes an electrical connector 312 and a storage device 310 coupled thereto. The storage device 310 is configured to store operating parameters pertaining to the adapter assembly 200. Adapter assembly 200 is configured to convert rotation of coupling shafts (not explicitly shown) of handle assembly 100 into axial translations useful for operating the end effector 600. [0057] With reference to FIG. 4, adapter assembly 200 further includes the anvil coupler 270 removably supported in a distal end of outer tube 206. The anvil coupler 270 is axially and rotationally fixed within outer tube 206 of adapter assembly 200. Anvil coupler 270 is configured to couple a drive screw 276 to the anvil assembly 800, such that axial movement of anvil coupler 270, via a rotation of drive screw 276, results in a concomitant axial movement of anvil assembly 800.

[0058] A first transmission assembly 240 includes first rotatable proximal drive shaft 212 coupled to the first motor 152a, a second rotatable proximal drive shaft 281 , a rotatable distal drive shaft 282, and a coupling member 286, each of which are supported within the outer tube 206 of adapter assembly 200. First transmission assembly 240 functions to extend/retract anvil assembly 800 of adapter assembly 200.

[0059] With reference to FIG. 5, the adapter assembly 200 includes a second transmission assembly 250 for interconnecting the second motor 152b and a first driver 730 of reload 700 (FIG. 10), wherein the second transmission assembly 250 converts and transmits a rotation of the second motor 152b to an axial translation of an outer flexible band assembly 255 of adapter assembly 200, and in turn, to optionally move the first driver 730 of the reload 700 to move the second ring 904 in a distal axial direction.

[0060] The second transmission assembly 250 of adapter assembly 200 includes the outer flexible band assembly 255 secured to driver coupler 254. A second rotatable proximal drive shaft 220 is coupled to the second motor 152b and is configured to actuate that driver coupler 254, which converts rotational movement into longitudinal movement. Outer flexible band assembly 255 includes first and second flexible bands 255a, 255b laterally spaced and connected at proximal ends thereof to a support ring 255c and at distal ends thereof to a proximal end of a distal pusher 255d. Each of the first and second flexible bands 255a, 255b is attached to support ring 255c and distal pusher 255d. Outer flexible band assembly 255 further includes first and second connection extensions 255e, 255f extending proximally from support ring 255c. First and second connection extensions 255e, 255f are configured to operably connect outer flexible band assembly 255 to driver coupler 254 of second transmission assembly 250.

[0061] With reference to FIG. 6, the adapter assembly 200 also includes a third transmission assembly 260 having a third rotatable proximal drive shaft 222 for interconnecting the third motor 152c and a second driver 740 of reload 700 (FIG. 10), wherein the third transmission assembly 260 converts and transmits a rotation of the third motor 152c to an axial translation of an outer flexible band assembly 265 of adapter assembly 200, and in turn, to advance the second driver 740 of the reload 700.

[0062] Inner flexible band assembly 265 includes first and second flexible bands 265a, 265b laterally spaced and connected at proximal ends thereof to a support ring 265c and at distal ends thereof to a proximal end of a support base 265 d. Each of first and second flexible bands 265a, 265b are attached to support ring 265c and support base 265d. Inner flexible band assembly 265 further includes first and second connection extensions 265e, 265f extending proximally from support ring 265c. First and second connection extensions 265e, 265f are configured to operably connect inner flexible band assembly 265 to driver 264 of third transmission assembly 260. Support base 265d extends distally from flexible bands 265a, 265b and is configured to connect with a second driver 740 of reload 700.

[0063] Forces during an actuation of compression ring device 900 may be measured by the strain gauge 408b in order to monitor and control processes, such as clamping, compression, and locking of the compression ring device 900. The strain gauge 408b of adapter assembly 200 measures and monitors the retraction of anvil assembly 800, since the anvil coupler 270 passes through the strain gauge 408b. The strain gauge 408b of adapter assembly 200 also measures and monitors movement of the first ring 902 and the second ring 904, since the first and second flexible bands 255a, 255b also pass through the strain gauge 408b. During clamping, compression, and locking, a reaction force is exerted on anvil assembly 800 and the reload 700, which is communicated to a strain sensor of the strain gauge 408b.

[0064] Strain sensor of strain gauge 408b may be any device configured to measure strain (a dimensionless quantity) on a component of the adapter assembly 200, such that, as the component deforms, a metallic foil of the strain sensor is also deformed, causing an electrical resistance thereof to change, which change in resistance is then used to calculate loads experienced by anvil coupler 270.

[0065] The strain gauge 408b measures and monitors the retraction of anvil assembly 800 as well as compression of the first and second rings 902 and 904. This distally directed reaction force is communicated from anvil assembly 800 to the strain gauge 408b. Strain gauge 408b is also electrically connected to the electrical connector 312 (FIG. 3) via wired or wireless connections. The strain gauge 408b then communicates signals to main controller circuit board display 146 of handle assembly 100 to provide the user with real-time information related to the status of the handle assembly 100.

[0066] The reload 700 includes a storage device 402 and the circular adapter assembly 200 also includes a storage device 310 (FIG. 3). The storage devices 402 and 310 include non-volatile storage medium (e.g., EEPROM) that is configured to store any data pertaining to the reload 700 and the circular adapter assembly 200, respectively, including but not limited to, usage count, identification information, model number, serial number, stroke length, maximum actuation force, minimum actuation force, factory calibration data, and the like. In embodiments, the data may be encrypted and is only decryptable by devices (e.g., main controller 147) having appropriate keys. The data may also be used by the main controller 147 to authenticate the circular adapter assembly 200 and/or the reload 700. The storage devices 402 and 310 may be configured in read only or read/write modes, allowing the main controller 147 to read as well as write data onto the storage device 402 and 310.

[0067] Prior to operation of the powered surgical device 10, the power handle 101 is enclosed within the shell housing 11 and the adapter assembly 200 is coupled to handle assembly 100. After attachment of circular adapter assembly 200, handle assembly 100 initially verifies that circular adapter assembly 200 is coupled thereto by establishing communications with the storage device 310 of the circular adapter assembly 200 and authenticates circular adapter assembly 200. The data (e.g., usage count) stored on the storage device 310 is encrypted and is authenticated by the power handle 101 prior to determining whether the usage count stored on the storage device 310 exceeds the threshold (e.g., if the adapter assembly 200 has been previously used). Power handle 101 then performs verification checks (e.g., end of life checks, anvil assembly 800 missing, etc.) and calibrates circular adapter assembly 200 after the handle assembly 100 confirms that the anvil assembly 800 is attached.

[0068] With reference to FIGS. 7-19, one embodiment of an end effector 600, which includes an annular reload 700 and an anvil assembly 800 is shown. As shown in FIGS. 7-9, the anvil assembly 800 includes a head assembly 810 secured to a rod 820. The head assembly 810 may be coupled to the rod 820 via one or more bolts 817 or any other suitable attachment mechanisms. The rod 820 includes a centrally defined lumen 818 configured to receive a trocar 830 (FIG. 8), which is coupled to the coupling member 286 of the first transmission assembly 240 (FIG. 4). The trocar 830 is configured to be inserted into the rod 820, such that axial movement of trocar 830, via the first transmission assembly 240, results in a concomitant axial movement of anvil assembly 800.

[0069] The end effector 600 houses a compression ring device 900, which includes a first ring 902 forming an outer portion 816 of the head assembly 810 and a second ring 904 disposed in the reload 700. The head assembly 810 also includes an inner portion 814, which is attached to the rod 820, as described above. The outer portion 816 (i.e., the first ring 902) is separably coupled, e.g., via cutting, to the inner portion 814 of the head assembly 810. The head assembly 810 may be formed from any material that may be cut to detach the outer portion 816 from the inner portion 814. Suitable materials for the head assembly 810 may be any thermoplastic polymer. The inner portion 814 is connected to the outer portion 816 via a connection portion 815 which is thinner than the inner portion 814 and the outer portion 816. The inner portion 814 is coupled to the rod 820 as described above, such that after separating the outer portion 816, the inner portion 814 remains attached to the rod 820, allowing for its withdrawal.

[0070] As shown in FIGS. 7, 8, and 10, the annular reload 700 is removably coupled to the distal end portion of the adapter assembly 200. The reload 700 includes a first driver 730, which is configured to engage the distal pusher 255d of the second transmission assembly 250. With reference to FIG. 5, the second transmission assembly 250 interconnects the second motor 152b and the first driver 730 of reload 700, wherein the second transmission assembly 250 converts and transmits a rotation of the second motor 152b to an axial translation of an outer flexible band assembly 255 of adapter assembly 200, and in turn, to move the first driver 730 of the reload 700 to move distally and engage the second ring 904 disposed in the reload 700.

[0071] The reload 700 also includes a second driver 740, which is configured to engage the support base 265d of the third transmission assembly 260. With reference to FIG. 6, the third transmission assembly 260 interconnects the third motor 152c and the second driver 740 of reload 700, wherein the third transmission assembly 260 converts and transmits a rotation of the third motor 152c to an axial translation of an outer flexible band assembly 265 of adapter assembly 200, and in turn, to move the second driver 740 of the reload 700 to move distally and to move an annular knife 744 disposed concentrically within the second ring 904.

[0072] With reference to FIGS. 7, 8, and 10-12, the second ring 904 includes a plurality (e.g., 2 or more) of locking pins 906. The second ring 904 includes a plurality of proximal openings configured to securely hold the locking pins 906, such that the locking pins 906 are movable by the first driver 730. The locking pins 906 may include an engagement surface configured abut the first driver 730.

[0073] With reference to FIGS. 13-17, forming an end-to-end anastomosis between separated alimentary tract portions SI and S2 using the compression ring device 900 includes inserting and attaching the anvil assembly 800 to a distal portion S 1 of the alimentary tract AT. The reload 700 while attached to the adapter assembly 200 is inserted into a proximal portion S2 of the alimentary tract AT. The trocar 830 is then inserted into the rod 820 to attach the anvil assembly 800. The user presses the toggle control button 30 to begin the clamping process on the tissue interposed between the distal and second rings 902 and 904 by pressing on the bottom portion of the toggle control button 30.

[0074] The clamping process may be accomplished by approximating the distal and second rings 902 and 904 relative to each other. The anvil assembly 800 is retracted by the first transmission assembly 240, thereby moving the first ring 902 proximally and clamping the tissue. The clamping process may continue until a clamping threshold is reached, after which, the process may transition to controlled tissue compression until a compression threshold is reached. In addition to monitoring the clamping threshold through the strain gauge 408b, clamping may be also monitored using light absorption detectors for monitoring optical properties of the tissue and/or bioimpedance sensors for monitoring electrical properties of the tissue. In further embodiments, clamping may be performed until the calibrated gap is reached. The thresholds and the gap may be adjustable during the compression process based on the feedback from the sensors. Compression of the tissue may follow clamping by continued retraction of the anvil assembly 800 until a desired tissue compression is reached, which may also be determined based on measured strain through the strain gauge 408b. The powered surgical device 10 may indicate (e.g., on the display 146) that clamping and/or compression is complete.

[0075] Once tissue is compressed, the locking process may be initiated manually, by pressing the toggle control button 30, or automatically once tissue compression is confirmed by the main controller 147, i.e., compression threshold is reached. The locking process includes advancing the first driver 730 distally, which pushes the locking pins 906 through the second ring 904 and into the first ring 902. More specifically, the locking pins 906 may be aligned with a plurality of corresponding distal openings 910, which are configured to receive and retain the locking pins 906 therein. The alignment of the distal openings 910 may be accomplished by aligning the anvil assembly 800 to the trocar 830 via splines or other mechanical features disposed on the rod 820. The locking pins 906 may include barbs, ridges, or other unidirectional features to allow for the locking pins 906 to be secured within the distal openings 910, thereby securing the distal and second rings 902 and 904 once the locking pins 906 are embedded inside the first ring 902. The locking pins 906 may be advanced until a locking force threshold is reached. The powered surgical device 10 may indicate (e.g., on the display 146) that locking is complete. This secures the two sections SI and S2 of the alimentary tract within the compression ring device 900 as shown in FIGS. 15 and 16.

[0076] After the compression ring device 900 is locked, the connected sections SI and S2 may be cut along with the head assembly 810 to separate the outer portion 816 (i.e., the first ring 902) from the inner portion 814. The cutting process may be initiated manually, by pressing the toggle control button 30, or automatically once the locking process is confirmed by the main controller 147, i.e., locking threshold is reached. The cutting process includes advancing the second driver 740 distally, which moves the annular knife 744 disposed concentrically within the second ring 904. The annular knife 744 cuts through the connected portions SI and S2 and thin and/or perforated portion 815 interconnecting the outer portion 816 (i.e., the first ring 902) and the inner portion 814 of the head assembly 810. This separates the anvil assembly 800 from the outer portion 816 allowing for retraction of the trocar 830 along with inner portion 814 from the locked compression ring device 900 that is forming the EEA as shown in FIGS. 18 and 19.

[0077] With reference to FIGS. 20-27 an electrical stimulation compression ring device is described which is based on the compression ring device 900 but additionally includes electrical stimulation circuitry. FIG. 20 shows an embodiment of the electrical stimulation compression ring device 1000, which includes a first ring 1002 and a second ring 1004. The first and second rings 1002 and 1004 structurally are substantially similar to the first and second rings 902 and 904 and operate in a similar manner, i.e., by compression and locking together via locking pins to maintain the anastomosis. The first ring 1002 includes one or more first electrodes 1006 and the second ring 1004 includes one or more second electrodes 1008 disposed on inner, i.e., anastomosiscontacting, surfaces 1003 and 1005, respectively. The first and second electrodes 1006 and 1008 are configured to transmit electrical stimulation energy through the tissue that is compressed by the first and second rings 1002 and 1004. FIG. 21 shows another embodiment of the electrical stimulation compression ring device 1000 where only one of the rings 1002 and 1004 includes first and second electrodes 1006 and 1008. In this embodiment, the electrical stimulation energy is still provided to the anastomosis compressed between the rings 1002 and 1004 but obviates the need for providing electrical stimulation circuitry in both rings 1002 and 1004.

[0078] With reference to FIGS. 22 and 23, a sleeve 1010 may be disposed over the anastomosis connecting alimentary tract portions S 1 and S2. The sleeve 1010 may be formed from a biodegradable or a bioabsorbable material such that the sleeve 1010 is resorbed after a period of time, which may be from about 2 weeks to about 10 weeks. The sleeve 1010 is used to promote healing at the anastomosis site and additionally may include circuitry for communicating with the electrical stimulation compression ring device 1000.

[0079] FIG. 24 shows an external control device 1020 for communicating and controlling the electrical stimulation compression ring device 1000. The external control device 1020 may be any suitable computing device, such as a smart phone, a tablet, or a purpose-built computing device as shown in FIG. 24. The external control device 1020 may include a display screen 1022 for displaying operating parameters of the electrical stimulation compression ring device 1000 and/or measured tissue parameters of the anastomosis site. The display screen 1022 may be a touch screen and display a graphical user interface (GUI) 1024 for interfacing with the external control device 1020 and controlling operation of the electrical stimulation compression ring device 1000. In embodiments, other user input devices may be used, such as, a directional pad, buttons, etc., the external device 1020 may be attached to the patient using an adhesive patch 1026 or any other suitable mechanism, e.g., belt, harness, etc.

[0080] FIG. 25 shows a printed circuit board (PCB) 1030 that is disposed inside one or both of first and second rings 1002 and 1004. The PCB 1030 is used for packaging a plurality of electronic components that are described in FIG. 26. The PCB 1030 may be a rigid or a flexible PCB and may have any suitable shape that may fit inside the first and/or second rings 1002 and 1004.

[0081] FIG. 26 shows an electrical stimulation system 1045 which includes the electrical stimulation compression ring device 1000 and the external control device 1020. With respect to the electrical stimulation compression ring device 1000, the electronic components described below may be included in one or both of the first and second rings 1002 and 1004. The electronic components may be split up between the first and second rings 1002 and 1004 or in embodiments, the components may be duplicated (i.e., redundant) in the first and second rings 1002 and 1004. [0082] The electrical stimulation compression ring device 1000 includes an electrical stimulation circuit 1035 having a power source 1040, which may be a rechargeable battery, that provides electrical power to all of the components. The electrical stimulation compression ring device 1000 also includes a controller 1044 (e.g., microcontroller), which controls electrical stimulation through first and second electrodes 1006 and 1008 according to a control algorithm of FIG. 27, which may be stored as software instructions in a memory 1042. The memory 1042 may include transitory (e.g., RAM) and non-transitory (e.g., flash storage) memory. The electrical stimulation compression ring device 1000 includes an electrical stimulation signal generator 1007, which may include any suitable power converter topology including one or more switching devices (e.g., field-effect transistors) for converting DC energy from the power source 1040 to stimulation signal, which may be a DC or AC signal.

[0083] A processor 1046 may also be included for controlling communication with the external control device 1020 via a wireless transmitter 1048. Wireless communication may be achieved via one or more wireless configurations, e.g., radio frequency, optical, Wi-Fi, Bluetooth (an open wireless protocol for exchanging data over short distances, using short length radio waves, from fixed and mobile devices, creating personal area networks (PANs), ZigBee® (a specification for a suite of high level communication protocols using small, low-power digital radios based on the IEEE 122.15.4-1203 standard for wireless personal area networks (WPANs)). In embodiments, a wired connection may be provided by one or more leads extending from the processor 1046 to the external control device 1020.

[0084] The electrical stimulation compression ring device 1000 may include one or more sensors 1050, which may be optical sensors, e.g., an optical transmitter and an optical receiver. The optical transmitter may include one or more LEDs for emitting light at visible light, near infrared, and infrared frequency. The optical receiver may be a photodiode or an image sensor (e.g., CMOS, CCD, etc.). The optical transmitter and receiver may be placed on opposing rings 1002 and 1004 to measure transmissive tissue properties. The optical transmitter and receiver may also be placed on the same ring 1002 or 1004 to measure reflective tissue properties. Optical tissue properties include oxygenation, hydration, perfusion, etc. [0085] The first and second electrodes 1006 and 1008 may also be used to sense electrical properties of the tissue, such as impedance. Impedance may be determined by providing an electrical signal through the first and second electrodes 1006 and 1008 having known properties, e.g., voltage and current, and calculating the impedance of the tissue.

[0086] The power source 1040 may be coupled to a first induction coil 1052 for receiving wireless electrical power from the external control device 1020. This arrangement allows for recharging the power source 1040 thereby minimizing the size of the power source 1040. The first induction coil 1052 is aligned with a second induction coil 1062 of the external control device 1020, which may have a larger power source 1060 for powering the external control device 1020 and simultaneously charging the power source 1040 of the electrical stimulation compression ring device 1000. A charging port 1063 (e.g., USB type port) may be included in the external control device 1020, to allow for charging the power source 1060, which may be any suitable rechargeable battery.

[0087] The external control device 1020 also includes a controller 1074 and a memory 1072, which may include transitory (e.g., RAM) and non-transitory (e.g., flash storage) memory. The controller 1074 may control charging through the second induction coil 1062. Further, the controller 1074 may control the display screen 1022 and the GUI 1024. The GUI 1024 may be used for output, e.g., to display current tissue parameters of the anastomosis site, such as tissue impedance, and for input, e.g., receive user input to select a stimulation regimen, duration, amplitude, etc. A processor 1076 may also be included and may communicate with the stimulation compression ring device 1000 through a wireless receiver 1078 for receiving data from the wireless transmitter 1048.

[0088] With reference to FIG. 27, a method 1100 of applying electrical stimulation to the anastomosis through the electrical stimulation compression ring device 1000 is depicted. The method may be embodied as software instructions stored in memory 1042 and/or 1072 executable by the controller 1044 and/or 1074, respectively. Electrical stimulation is commenced following implantation of the electrical stimulation compression ring device 1000 as described above with respect to FIGS. 7-19. In addition, communication is established with the electrical stimulation compression ring device 1000 and the external control device 1020 via the transmitter 1048 and the receiver 1078. Communication may be established via a pairing routine displayed on the GUI 1024 of the external control device 1020. [0089] At step 1102, electrical stimulation is started, which may be done via the GUI 1024 or another input device on the external control device 1020. The GUI 1024 may display a menu providing for selecting of one or more parameters, such as time parameters, e.g., total duration and daily schedule of application of electrical stimulation signals and electrical parameters, e.g., frequency of electrical pulses, duty cycle, desired end impedance of tissue, etc. Suitable electrical stimulation signals may be rectified AC signals. The user may select a frequency from about 10- 15 MHz and the voltage oscillating between 0 and 5 V. The user may also select total duration, which may be from about 1 day to about 14 days and daily schedule, which may be from about 1 hour to about 24 hours, and in embodiments from about 2 hours to about 8 hours daily. The GUI 1024 may also allow for selection of whether the electrical stimulation is feedback enabled, where the electrical stimulation is controlled based on one or more measured tissue parameters, such as impedance. The user may select one or more tissue parameters, such as oxygenation, hydration, perfusion, impedance, etc. as well as corresponding thresholds for each of the parameters. Once the selections are made, the user may confirm the start of delivery of the electrical stimulation.

[0090] At step 1104, the controller 1074 receives the selected user parameters and checks whether stimulation feedback was enabled at step 1102. If no feedback is enabled, then at step 1106, the controller 1074 signals the controller 1044 to apply electrical stimulation signals according to the selected parameters, e.g., duration, schedule, etc. If feedback was selected, then at step 1108, the controller 1074 signals the controller 1044 to apply electrical stimulation using a feedback algorithm, which uses the measured tissue properties, e.g., optical and/or electrical tissue parameter, as a setpoint or threshold. The controller 1074 and/or the controller 1044 continuously (e.g., at set sampling intervals) check a tissue parameter and compare the tissue parameter to its preset threshold. At step 1110, the controller 1074 signals the controller 1044 to adjust electrical stimulation based on the measured parameter and its difference relative to the corresponding preset threshold. As an example, if measured impedance is lower than preset impedance threshold, then the controller 1044 increases the energy delivered by electrical stimulation, e.g., increasing the voltage, duration, duty cycle, etc. This process of comparing the measured parameter to preset threshold continues until the measured parameter reaches the preset threshold and application of electrical stimulation is terminated at step 1112. The GUI 1024 may display a message that the treatment process is complete. In embodiments, the GUI 1024 may continuously update currently measured tissue parameter to provide the clinician with real-time feedback on the healing process. In further embodiments, the external control device 1020 may be coupled via a communication network, e.g., Internet, WAN, etc. to other patient monitoring devices to provide real-time feedback to clinicians.

[0091] It will be understood that various modifications may be made to the embodiments of the presently disclosed devices. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.

[0092] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non- transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0093] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0094] The following examples are illustrative of the techniques described herein.

[0095] Example 1. An electrical stimulation compression ring device comprising: a first ring for engaging a first segment of an alimentary tract portion; and a second ring for engaging a second segment of the alimentary tract portion, wherein at least one of the first ring or the second ring is movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring, and at least one of the first ring or the second ring includes an electrical stimulation circuit for generating an electrical stimulation signal and at least one electrode disposed on an anastomosis-contacting surface, the at least one electrode configured to deliver the electrical stimulation signal to the anastomosis. [0096] Example 2. The electrical stimulation compression ring device according to example

1, wherein the at least one electrode includes a first electrode and a second electrode.

[0097] Example 3. The electrical stimulation compression ring device according to example

2, wherein the first electrode and the second electrode are disposed on one of the first ring or the second ring.

[0098] Example 4. The electrical stimulation compression ring device according to example 2, wherein the first electrode is disposed on the first ring and the second electrode is disposed on the second ring.

[0099] Example 5. The electrical stimulation compression ring device according to example 2, wherein the electrical stimulation circuit includes a battery and a stimulation signal generator for converting direct current from the battery to generate the electrical stimulation signal.

[00100] Example 6. The electrical stimulation compression ring device according to example

1, wherein the electrical stimulation signal is an alternating current signal.

[00101] Example 7. The electrical stimulation compression ring device according to example

5, further comprising a memory storing a stimulation signal delivery algorithm and a controller for controlling the stimulation signal generator using the stimulation signal delivery algorithm.

[00102] Example 8. The electrical stimulation compression ring device according to example

7 , further comprising at least one sensor for measuring a property of the anastomosis.

[00103] Example 9. The electrical stimulation compression ring device according to example

8, wherein the controller controls the stimulation signal generator based on the measured property of the anastomosis.

[00104] Example 10. An electrical stimulation system comprising: an electrical stimulation compression ring device including: a first ring for engaging a first segment of an alimentary tract portion; and a second ring for engaging a second segment of the alimentary tract portion, wherein at least one of the first ring or the second ring is movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring, and at least one of the first ring or the second ring includes an electrical stimulation circuit for generating an electrical stimulation signal and at least one electrode disposed on an anastomosis-contacting surface, the at least one electrode configured to deliver the electrical stimulation signal to the anastomosis; and an external control device in communication with the electrical stimulation compression ring device and configured to control delivery of the electrical stimulation signal to the anastomosis. [00105] Example 11. The electrical stimulation system according to example 10, wherein the at least one electrode includes a first electrode and a second electrode.

[00106] Example 12. The electrical stimulation system according to example 11, wherein the first electrode and the second electrode are disposed on one of the first ring or the second ring.

[00107] Example 13. The electrical stimulation system according to example 11, wherein the first electrode is disposed on the first ring and the second electrode is disposed on the second ring.

[00108] Example 14. The electrical stimulation system according to example 11, wherein the electrical stimulation circuit includes a battery and a stimulation signal generator for converting direct current from the battery to generate the electrical stimulation signal.

[00109] Example 15. The electrical stimulation system according to example 11, wherein the electrical stimulation signal is an alternating current signal.

[00110] Example 16. The electrical stimulation system according to example 14, further comprising a memory storing a stimulation signal delivery algorithm and a controller for controlling the stimulation signal generator using the stimulation signal delivery algorithm.

[00111] Example 17. The electrical stimulation system according to example 16, further comprising at least one sensor for measuring a property of the anastomosis, wherein the controller controls the stimulation signal generator based on the measured property of the anastomosis.

[00112] Example 18. The electrical stimulation system according to example 10, wherein the external control device includes user input means for receiving user input to select at least one parameter of the delivery of the electrical stimulation signal to the anastomosis.

[00113] Example 19. The electrical stimulation system according to example 18, wherein the at least one parameter is duration or frequency of the delivery of the electrical stimulation signal to the anastomosis.

[00114] Example 20. The electrical stimulation system according to example 18, wherein the at least one parameter is an energy parameter of the electrical stimulation signal.

Claims

WHAT IS CLAIMED IS:

1. An electrical stimulation compression ring device (1000) comprising: a first ring (1002) for engaging a first segment (SI) of an alimentary tract portion (AT); and a second ring (1004) for engaging a second segment (S2) of the alimentary tract portion, wherein at least one of the first ring or the second ring is movable relative to each other to compress the first segment and the second segment to form an anastomosis between the first ring and the second ring, and at least one of the first ring or the second ring includes an electrical stimulation circuit (1035) for generating an electrical stimulation signal and at least one electrode disposed on an anastomosis-contacting surface, the at least one electrode (1006, 10008) configured to deliver the electrical stimulation signal to the anastomosis.

2. The electrical stimulation compression ring device according to claim 1, wherein the at least one electrode includes a first electrode (1006) and a second electrode (1008).

3. The electrical stimulation compression ring device according to claim 2, wherein the first electrode and the second electrode are disposed on one of the first ring or the second ring.

4. The electrical stimulation compression ring device according to claim 2, wherein the first electrode is disposed on the first ring and the second electrode is disposed on the second ring.

5. The electrical stimulation compression ring device according to any of the preceding claims, wherein the electrical stimulation circuit includes a battery and a stimulation signal generator for converting direct current from the battery to generate the electrical stimulation signal.

6. The electrical stimulation compression ring device according to claim 1, device according to any of the preceding claims, wherein the electrical stimulation signal is an alternating current signal.

7. The electrical stimulation compression ring device according to any of the preceding claims, further comprising a memory (1072) storing a stimulation signal delivery algorithm and a controller (1074) for controlling the stimulation signal generator using the stimulation signal delivery algorithm.

8. The electrical stimulation compression ring device according to any of the preceding claims, further comprising at least one sensor (1050) for measuring a property of the anastomosis.

9. The electrical stimulation compression ring device according to claim 8, wherein the controller controls the stimulation signal generator based on the measured property of the anastomosis.

10. An electrical stimulation system comprising: the electrical stimulation compression ring device according to any of the preceding claims; and an external control device (1020) in communication with the electrical stimulation compression ring device and configured to control delivery of the electrical stimulation signal to the anastomosis.

11. The electrical stimulation system according to claim 10, wherein the external control device includes user input means (1024) for receiving user input to select at least one parameter of the delivery of the electrical stimulation signal to the anastomosis.

12. The electrical stimulation system according to claim 11, wherein the at least one parameter is duration or frequency of the delivery of the electrical stimulation signal to the anastomosis.

13. The electrical stimulation system according to claim 11 , wherein the at least one parameter is an energy parameter of the electrical stimulation signal.