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EP-4507587-B1 - COMPRESSION ANASTOMOSIS RINGS WITH ADJUSTABLE COMPRESSION PROFILE

EP4507587B1EP 4507587 B1EP4507587 B1EP 4507587B1EP-4507587-B1

Inventors

  • CAULK, Alexander W.
  • NICHOLAS, DAVID A.
  • STRASSNER, HALEY E.
  • ESCHBACH, Matthew S.

Dates

Publication Date
20260506
Application Date
20230412

Claims (4)

  1. A surgical device (10) for forming an anastomosis, the device comprising: an anvil assembly (800) including a head assembly (810) coupled to a rod (820), the head assembly (810) including an outer ring portion coupled to an inner portion via a connection portion; an annular reload (700) including: a proximal ring (904) having a plurality of pins (906) movably disposed therein; a first driver (730) movable distally and configured to engage the plurality of pins (960); an annular knife (733); and a second driver movable distally and configured to engage the annular knife; a first transmission assembly (240) coupled to and configured to move the anvil assembly (800) proximally toward the annular reload (700) to clamp tissue between the anvil assembly (800) and the annular reload (700); a second transmission assembly (250) coupled to and configured to move the first driver (730) distally to move the plurality of pins (906) through the proximal ring (904), the tissue, and into the outer ring portion to embed the plurality of pins (906) in the outer ring portion; and a third transmission assembly (260) coupled to and configured to move the second driver and the annular knife (733) through the tissue and the connection portion of the head assembly (810) to separate the outer ring portion from the inner portion; characterized in that the surgical device (10) comprises: at least one motor configured to move the third transmission assembly; a sensor configured to measure at least one property of the tissue; a controller (147) configured to determine whether an anastomosis has been formed or optimal conditions for forming an anastomosis based on the at least one property of the tissue, wherein the controller is further configured to control the at least one motor to move the third transmission assembly based on the determination that the anastomosis has been formed thereby advancing the annular knife through the tissue and the connection portion of the head assembly (810) to separate the outer ring portion from the inner portion.
  2. The surgical device (10) according to claim 1, wherein the anvil assembly (800) is formed from a thermoplastic polymer.
  3. The surgical device (10) according to claim 1, wherein the at least one motor is configured to move at least one of the first transmission assembly (240), the second transmission assembly (250), or the third transmission assembly (260).
  4. The surgical device (10) according to claim 1, wherein the sensor is configured to measure at least one of a mechanical property, optical property, or electrical property of the tissue.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63/330,483 filed on April 13, 2022. BACKGROUND 1. Technical Field The present disclosure relates to surgical devices. More specifically, the present disclosure relates to electromechanical surgical systems for performing surgical procedures. 2. Background of Related Art 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. US4957499A describes a surgical suturing instrument for establishing circular compression anastomoses in the organs of the digestive tract. EP2316353A1 describes a surgical fastening apparatus. US2008/015617A1 describes a compression anastomosis ring assembly for use in joining severed organ wall portions of a hollow organ. SUMMARY The invention is defined by the appended independent claims. Optional features are set out in the appended dependent claims. 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 assembly to form an anastomosis. The compression ring assembly 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 assembly to move the two rings together. The end effector also includes compression and locking actuation mechanisms to secure the compression ring assembly 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. 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 assembly 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 assembly 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 assembly and is retracted, allowing for removal of the powered surgical device from the alimentary tract. The compression ring assembly 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 assembly 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 co