阅读说明：本技术 用于优化的组织缝合的组织松弛监测 (Tissue relaxation monitoring for optimized tissue suturing ) 是由 黑莉·施特拉斯纳 戴维·E·瓦伦丁 亚历山大·哈特 斯蒂芬·R·凯茜 桑娅·A·巴德 雅梅 于 2021-05-20 设计创作，主要内容包括：本发明题为“用于优化的组织缝合的组织松弛监测”。一种圆形缝合装置,圆形缝合装置包括：柄部组件,柄部组件包括处理器；适配器组件,适配器组件包括套管针组件和应变仪组件；可操作地固定到适配器组件的重新装载组件,重新装载组件包括钉仓；和砧座组件,砧座组件可释放地固定到套管针组件并相对于钉仓可移动地定位在间隔位置和夹紧位置之间。处理器包括用于确定夹持在钉仓和砧座组件之间的组织何时已达到预先确定的组织松弛百分比的软件。一种在缝合规程期间优化组织松弛的方法,方法包括将组织夹持在砧座组件和重新装载组件之间,计算所夹持组织的组织松弛百分比,以及当组织松弛百分比等于或小于预先确定的组织松弛百分比时开始缝合序列。(The invention is entitled "tissue relaxation monitoring for optimized tissue suturing". A circular suturing device comprising: a handle assembly comprising a processor; an adapter assembly including a trocar assembly and a strain gauge assembly; a reload assembly operably secured to the adapter assembly, the reload assembly comprising a staple cartridge; and an anvil assembly releasably secured to the trocar assembly and movably positionable relative to the staple cartridge between a spaced position and a clamped position. The processor includes software for determining when tissue clamped between the staple cartridge and the anvil assembly has reached a predetermined percentage of tissue relaxation. A method of optimizing tissue relaxation during a stapling procedure, the method comprising clamping tissue between an anvil assembly and a reload assembly, calculating a tissue relaxation percentage of the clamped tissue, and initiating a stapling sequence when the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage.)

1. A circular suturing device, comprising:

a handle assembly comprising a processor;

an adapter assembly operably secured to the handle assembly and including a trocar assembly and a strain gauge assembly;

a reload assembly operably secured to the adaptor assembly, the reload assembly comprising a staple cartridge; and

an anvil assembly releasably secured to the trocar assembly and movably positionable relative to the staple cartridge between a spaced position and a clamped position, wherein the processor includes software for determining when tissue clamped between the staple cartridge and the anvil assembly has reached a predetermined percentage of tissue slack.

2. The circular stapling device of claim 1, wherein the predetermined tissue relaxation percentage is between about 1% and about 0.5%.

3. The circular suturing device of claim 1, wherein the strain gauge assembly comprises a plurality of strain gauges.

4. The circular stapling apparatus of claim 1, wherein the software is configured to activate an alarm when the predetermined tissue relaxation percentage is reached.

5. The circular suturing device of claim 4, wherein the software utilizes audible, visual, and/or tactile feedback to alert a clinician.

6. The circular stapling apparatus of claim 1, wherein the software is configured to begin a stapling sequence upon reaching the predetermined tissue relaxation percentage.

7. The circular stapling apparatus of claim 1, wherein the software is configured to activate an alarm after the tissue is clamped for a predetermined period of time.

8. The circular stitching device of claim 7, wherein the predetermined time is 15 seconds.

9. The circular stapling apparatus of claim 1, wherein the software is configured to sample the clamping force at a predetermined sampling rate.

10. The circular stitching device of claim 9, wherein the predetermined sampling rate is 400 milliseconds.

11. A method of optimizing tissue relaxation during a suturing procedure, the method comprising:

clamping tissue between the anvil assembly and the reload assembly;

calculating the percent tissue relaxation of the clamped tissue; and

when the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage, a suturing sequence is initiated.

12. The method of claim 11, wherein clamping the tissue comprises moving the anvil assembly relative to the reload assembly until a predetermined gap is reached between the anvil assembly and a staple cartridge of the reload assembly.

13. The method of claim 11, wherein calculating the tissue relaxation percentage comprises using a 6 tap strain gauge history buffer.

14. The method of claim 11, wherein the stapling sequence is initiated when the measured tissue relaxation percentage is between about 0.5% and 1%.

15. The method of claim 11, wherein initiating the stapling sequence occurs 15 seconds after completion of clamping the tissue.

16. The method of claim 11, further comprising initiating a cleavage sequence.

17. The method of claim 16, wherein the cutting sequence begins upon completion of the stapling sequence.

18. The method of claim 17, wherein the cutting sequence is initiated when the tissue relaxation percentage is equal to or less than a second predetermined tissue relaxation percentage, or after a predetermined period of time has elapsed, whichever occurs first.

19. The method of claim 16, wherein initiating the cutting sequence is automated.

20. The method of claim 11, wherein the stapling sequence is initiated when the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage, or after a predetermined time has elapsed, whichever occurs first.

Technical Field

The present disclosure relates generally to powered surgical stapling devices and, more particularly, to powered surgical stapling devices that include software that utilizes strain measurements to optimize the stapling and/or cutting of tissue.

Background

The powered surgical stapling device includes a handle assembly, an adapter assembly including a proximal portion supported on the handle assembly, and a tool assembly supported on a distal portion of the adapter assembly. The tool assembly generally includes a reload assembly and an anvil assembly movably positioned relative to the reload assembly to clamp tissue therebetween. The stapling apparatus may also include strain gauges for measuring properties of the clamped and/or stapled tissue, such as tissue thickness, tissue compression, etc., and/or parameters associated with staple formation or tissue cutting, such as cutting force, firing force, etc. Typically, the strain gauge is supported within the adapter assembly and is formed from electronics that can be sterilized or reprocessed to facilitate reuse of the adapter assembly. Such electronics are expensive.

During the stapling procedure, many surgeons wait a specified period of time, such as fifteen seconds or more, after reaching a predetermined tissue gap between the anvil assembly and the reload assembly while clamping the tissue. This waiting period provides slack to the clamped tissue, for example, allowing fluid to flow out of the clamped tissue into the surrounding tissue, and is intended to facilitate less traumatic staple firing. Waiting more than the time required for the clamped tissue to reach optimal relaxation lengthens the procedure time. Conversely, if the wait is not long enough to loosen the tissue, the stapled tissue may be unnecessarily damaged and/or cause staple malformation.

Accordingly, it would be beneficial to have a device and method for monitoring tissue relaxation and indicating when optimal tissue relaxation has been achieved.

Disclosure of Invention

A circular suturing device, comprising: a handle assembly comprising a processor; an adapter assembly operably secured to the handle assembly and including a trocar assembly and a strain gauge assembly; a reload assembly operably secured to the adapter assembly, the reload assembly comprising a staple cartridge; and an anvil assembly releasably secured to the trocar assembly and movably positionable relative to the staple cartridge between a spaced position and a clamped position. The processor includes software for determining when tissue clamped between the staple cartridge and the anvil assembly has reached a predetermined percentage of tissue relaxation (i.e., when the clamped tissue is determined to have stabilized).

In certain aspects of the present disclosure, the predetermined percent tissue relaxation is between about 1% and about 0.5%. The strain gauge assembly may include a plurality of strain gauges. The software may be configured to activate an alarm when a predetermined percentage of tissue relaxation is reached. The software may alert the clinician using audible, visual, and/or tactile feedback. The software may be configured to begin the suturing sequence when a predetermined percentage of tissue relaxation is reached. The software may be configured to activate an alarm after the tissue is clamped for a predetermined period of time. The predetermined time may be 15 seconds. The software may be configured to sample the clamping force at a predetermined sampling rate. The predetermined sampling rate may be 400 milliseconds.

A method of optimizing tissue relaxation during a stapling procedure, the method comprising clamping tissue between an anvil assembly and a reload assembly, calculating a tissue relaxation percentage of the clamped tissue, and initiating a stapling sequence when the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage.

In certain aspects of the present disclosure, clamping the tissue includes moving the anvil assembly relative to the reload assembly until a predetermined gap is reached between the anvil assembly and the staple cartridge of the reload assembly. Calculating the percent tissue relaxation may include using a 6-tap strain gauge history buffer. The stapling sequence may begin when the measured percent tissue relaxation is between about 0.05% and 1%. The beginning of the stapling sequence may occur 15 seconds after the completion of the clamping of the tissue.

Aspects of the method may also include initiating a cleavage sequence. The cutting sequence may begin upon completion of the stapling sequence. The cutting sequence may begin when the tissue relaxation percentage is equal to or less than a second predetermined tissue relaxation percentage, or after a predetermined period of time has elapsed, whichever occurs first. The start of the cleavage sequence may be automated. The stapling sequence may begin when the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage, or after a predetermined time has elapsed, whichever occurs first.

Drawings

Various aspects and features of the present disclosure are described with reference to the following drawings, in which like reference numerals represent the same or corresponding elements in each of the several views, and in which:

FIG. 1 is a side perspective view of a surgical stapling apparatus including an adapter assembly having a strain gauge assembly according to aspects of the present disclosure;

FIG. 2 is a side perspective view of the adapter assembly shown in FIG. 1, with the trocar assembly and strain gauge assembly shown in phantom;

FIG. 3 is a side perspective view of the distal portion of the adapter assembly shown in FIG. 2 with the outer sleeve removed and the tensiometer support separated from the adapter assembly;

FIG. 4 is a side perspective view of the trocar assembly and strain gauge housing and strain gauge anchor of the strain gauge assembly of FIG. 2;

FIG. 5 is a flow chart of a stitching sequence according to a method of the present disclosure; and is

Fig. 6 is a flowchart of the processing steps of the stitching sequence in the flowchart shown in fig. 5.

Detailed Description

Apparatus and methods for optimizing tissue stapling are now described in detail with reference to the drawings, wherein like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term "distal" refers to the portion of the component that is farther from the user, while the term "proximal" refers to the portion of the component that is closer to the user. Furthermore, the term "clinician" is commonly used to refer to medical personnel, including doctors, nurses, and support staff. As used herein, the term "about" means that the numerical values are approximate, and that minor variations will not significantly affect the practice of the disclosed aspects of the present disclosure. Where numerical limitations are used, "about" means that the numerical value can vary by ± 10% of the stated value, and remain within the scope of the disclosure, unless the context indicates otherwise.

The method of optimizing tissue stapling described below utilizes a strain gauge assembly of a circular stapling device to monitor strain gauge data, i.e., clamping force, during a stapling procedure. More specifically, and as will be described in further detail below, software in the suturing device uses the strain gauge data to calculate the clamping force and measure the clamping force at a specified sampling rate. From this, the percent change in force between each data sample was calculated. The software then applies the filter by calculating the average percent change over the specified amount of percent change reading. When the average percentage change calculation is equal to or less than the specified tissue relaxation percentage, the clinician is encouraged to begin the firing sequence. If the average percent change value is not equal to or less than the tissue relaxation percentage specified value before the predetermined period of time (e.g., fifteen seconds (15s)) has elapsed, the clinician is encouraged to begin the firing sequence after the predetermined period of time has elapsed.

FIG. 1 illustrates a circular stapling apparatus 10 that includes a handle assembly 12, an elongated body or adapter assembly 14, a reload assembly 16 releasably supported on the adapter assembly 14, and an anvil assembly 18 releasably supported for movement relative to the reload assembly 16 between an open position (FIG. 1) and a clamped position (not shown). While the method for optimizing tissue stapling will be described with reference to a circular stapling device, it is contemplated that aspects of the present disclosure may be modified for use with surgical stapling devices having alternative configurations.

The circular stapling apparatus 10 is shown as an electrically powered stapling apparatus that includes an electrically powered handle assembly 12 that may support one or more batteries (not shown). The adapter assembly 14 converts electrical power from the handle assembly 12 to the reload assembly 16 and anvil assembly 18, respectively, to staple and cut tissue. Examples of electrically powered suturing devices can be found in U.S. patents 9,055,943 and 9,023,014 and U.S. publications 2018/0125495 and 2017/0340351. Alternatively, it is contemplated that aspects of the present disclosure may be incorporated into a suturing device configured for use with a robotic system such as that disclosed in U.S. patent 9,962,159, and which does not include a handle assembly.

The handle assembly 12 of the circular stapling apparatus 10 includes a stationary grip 12a that supports an actuation button 13 for controlling the operation of various functions of the circular stapling apparatus 10, including, for example, the approximation of the reload assembly 16 and anvil assembly 18, the firing of staples from the reload assembly 16, and the cutting or coring of tissue.

A processor 20 is disposed within the handle assembly 12 and includes or is operatively connected to a memory chip 22. The memory chip 22 may include one or more of volatile, non-volatile, magnetic, optical, or electronic media, such as read-only memory (ROM), random-access memory (RAM), Electrically Erasable Programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor 20 may be any suitable processor (e.g., control circuitry) suitable for performing the operations, calculations and/or sets of instructions described in this disclosure, including but not limited to a hardware processor, a Field Programmable Gate Array (FPGA), a Digital Signal Processor (DSP), a Central Processing Unit (CPU), a microprocessor and combinations thereof. Those skilled in the art will appreciate that the processor may be replaced by any logical processor (e.g., control circuitry) suitable for executing the algorithms, calculations and/or instruction sets described herein.

The adapter assembly 14 includes a proximal portion 14a that is releasably coupleable to the handle assembly 12. The reload assembly 16 includes a proximal portion 16a releasably coupled to a distal portion 14b of the adapter assembly 14. The staple cartridge 24 is supported on the distal portion 16b of the reload assembly 16 and supports a plurality of surgical staples (not shown). The trocar assembly 26 is supported within the distal portion 14b of the adapter assembly 14 and extends through the reload assembly 16. Trocar assembly 26 includes a trocar member 28 for releasably securing and positioning anvil assembly 18 relative to reload assembly 16.

Fig. 2-4 illustrate the strain gauge assembly 30 supported within the distal portion 14b (fig. 2) of the adapter assembly 14, and a trocar assembly 40 received through and supported by the strain gauge assembly 30. The strain gauge assembly 30 is positioned between the trocar assembly 40 and the reload assembly 16. Using the strain gauge data provided by the strain gauge assembly 30, the clamping force between the staple cartridge 24 and the anvil assembly 18 of the reload assembly 16 may be calculated. Trocar assembly 40 releasably secures anvil assembly 18 (fig. 1) to circular stapling apparatus 10 and operates to advance and retract anvil assembly 18 relative to reload assembly 16. The software in the handle assembly 12 uses the strain gauge measurements to determine the clamping force over time. As will be described in further detail below, tissue relaxation occurs when the clamping force (i.e., the force on the tissue) is stabilized.

The strain gauge assembly 30 includes a strain gauge housing 32, a strain gauge anchor 34, and a strain gauge support 36 (fig. 3). A plurality of strain gauges 38 are supported on the extension portion 32a (fig. 4) of the tension gauge housing 32. For a detailed description of an exemplary strain gauge assembly, reference is made to U.S. patent application serial No. 16/809,023 filed on 3, 4, 2020. While shown as a strain gauge assembly 30, it is contemplated that the method of the present disclosure may be modified for use with any strain gauge assembly.

Fig. 5 shows a flow diagram of a suturing procedure for optimizing tissue suturing in accordance with aspects of the present disclosure. First, tissue to be stapled (not shown) is positioned between an anvil assembly (e.g., anvil assembly 18 (fig. 1)) and a staple cartridge (e.g., staple cartridge 24 (fig. 1)) of a reload assembly (e.g., reload assembly 16 (fig. 1)). The anvil assembly is then approximated toward the reload assembly to clamp tissue between the anvil assembly and the staple cartridge of the reload assembly. The anvil assembly is approximated toward the reload assembly until a predetermined clamping gap is reached between the anvil assembly and the staple cartridge.

The strain gauge data provided by the strain gauge assembly, such as strain gauge assembly 30 (fig. 2), is used to calculate the percent tissue relaxation, or more specifically, the percent change in clamping force between two sampling points. Tissue relaxation occurs when the compressed fluid within the clamped tissue has been able to flow into the adjacent tissue (i.e., the clamping force is stable). When the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage (typically 0.5% -1.0%), or after fifteen seconds has elapsed, it is determined that tissue relaxation has occurred, whichever occurs first. In aspects of the present disclosure, the software is configured to alert the clinician and begin the suturing sequence through audible, visual, and/or tactile feedback when optimal tissue relaxation has occurred. In certain aspects of the present disclosure, the stapling procedure may begin at any time after the anvil assembly and staple cartridge reach the clamp gap distance. It is also contemplated that the software may be programmed to automatically begin the suturing sequence after a tissue relaxation percentage is reached or 15 seconds have elapsed.

After the stapling sequence, a tissue cutting or coring sequence is initiated. The cutting sequence may be automated or may be initiated manually by the clinician. The cutting sequence may begin simultaneously with the stapling sequence, directly after completion of the stapling sequence, or after a subsequent period of time.

In certain aspects of the present disclosure, prior to beginning the cutting sequence, a tissue relaxation optimization similar to the tissue relaxation optimization described above may also be used to minimize tissue damage during cutting/coring of the stapled tissue. Thus, after the stapling sequence is completed and before the cutting sequence begins, the software in the handle assembly calculates the percent tissue relaxation from the strain gauge data provided by the strain gauge assembly. As with the stapling sequence, once the tissue relaxation percentage is equal to or less than a predetermined tissue relaxation percentage, or a predetermined period of time has elapsed, whichever occurs first, the clinician is alerted that the cutting sequence may begin. It is envisaged that the cutting sequence may be initiated automatically.

In an attempt to further optimize tissue stapling, it is contemplated that the strain gauge assembly may be used in conjunction with software to monitor the clamping force during tissue clamping. In the event that the clamping force exceeds a predetermined threshold, the software may slow the rate at which the tissue is clamped, or stop clamping altogether until the clamping force falls below the threshold.

FIG. 6 is a flow chart detailing the tissue relaxation optimization procedure. Although shown using a 6 tap strain gauge history buffer that is updated at a specified sampling rate, it is contemplated that more or less than a 6 tap strain gauge history buffer may be utilized. In one aspect of the disclosure, the sampling rate is a 400 millisecond interval.

After the buffer is full, successive strain gauge values are subtracted to calculate the differential change in force, which is then divided by the previous absolute strain gauge value to determine the percent change in force applied to the tissue. This yields five (5) delta percentage values, which are then averaged. In the next time period, all values in the buffer are shifted down and the new values are placed in the SGFt0 slots (slots). Thus, only the last five values are used in the calculation. When the new calculation is completed, the oldest values are discarded and do not form part of the new calculation. When the average delta percentage value is less than or equal to the specified tissue relaxation percentage, the tissue is determined to be relaxed and the user is encouraged to begin firing. As noted above, in certain aspects of the present disclosure, at a tissue relaxation percentage of between about 0.5% and about 1.0%, the tissue is considered sufficiently stable and no further significant change in force is possible.

The 6-tap strain gauge history is SGFt5, SGFt4, SGFt3, SGFt2, SGFt1, SGFt 0.

The Δ percent (DP) was calculated as follows:

percent Reduction (PR) was determined by averaging the Δ percentages as follows:

as described above, if the predetermined percentage of tissue relaxation is not detected within 15 seconds, the tissue is determined to be relaxed and the user is encouraged to begin firing.

The above-described devices and methods allow a clinician to make a more informed decision as to whether the clamped tissue has relaxed to the extent that tissue damage is minimized. The software also allows for the collection of tissue relaxation data that can be analyzed later to better understand the behavior of the tissue after clamping and before firing in the actual firing.

Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting and exemplary. It is envisaged that elements and features shown or described in connection with one aspect of the present disclosure may be combined with elements and features of another aspect without departing from the scope of the present disclosure. Likewise, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.