Systems and methods for anastomotic leak detection and prediction

Abstract

A system for monitoring anastomotic healing includes: an imaging device configured to observe a first distance at a first location between a first staple line and a second staple line at a first time, and a second distance at the first location at a second time; and a programmable device configured to calculate a difference between the first distance and the second distance and compare the difference to a known distance representing an anastomosis in a known condition.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 957,431, filed on January 6, 2020, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to anastomotic leakage. More specifically, this disclosure relates to devices and methods for detecting and predicting anastomotic leakage. Background Art

[0004] Anastomosis is a surgical joining of separate segments of a hollow organ. Typically, an anastomosis procedure follows a surgical procedure in which a diseased or defective segment of the hollow tissue is removed and the remaining end segments are pulled together and joined. Depending on the desired anastomosis procedure, the end segments can be joined by circular, end-to-end, or side-to-side organ reconstruction methods.

[0005] Anastomotic leakage occurs due to disruption of the anastomosis site, which is typically stapled together. In some cases, anastomotic leakage is the result of staple line disruption.

[0006] Accordingly, it would be beneficial to have systems and methods for monitoring anastomosis and for detecting and more accurately predicting the probability of leakage. Summary of the Invention

[0007] A system for monitoring anastomotic healing is provided. The system includes an imaging device and a programmable device. The imaging device observes a first distance at a first location between a first staple line and a second staple line at a first time, and observes a second distance at the first location at a second time. The programmable device is configured to calculate the difference between the first distance and the second distance and compare the difference to a known distance of an anastomosis exhibiting a known condition.

[0008] In certain aspects of the present disclosure, the known condition includes a healthy anastomosis. Alternatively or additionally, the known condition includes an anastomosis exhibiting leakage.

[0009] In some aspects, the imaging device can be configured to observe the distance between a first staple and a second staple within the first staple line. The programmable device can be configured to be worn by a patient. The staples within the first staple line can include a first coating, and the staples within the second staple line include a second coating different from the first coating. Alternatively, the staples within the first staple line can include at least one bead secured thereto.

[0010] In aspects of the present disclosure, the imaging device uses at least one of x-ray, MRI, CT scan, or ultrasound.

[0011] There is also provided a method for monitoring anastomotic healing. The method includes: observing a first distance between a first staple line and a second staple line at a first location at a first time; observing a second distance between the first staple line and the second staple line at the first location at a second time; calculating a difference between the first distance and the second distance; comparing the difference between the first distance and the second distance with a known value of a similar measurement in an anastomosis with a known condition; and determining an appropriate treatment process based on the comparison.

[0012] In certain aspects of the present disclosure, comparing the difference between the first distance and the second distance includes comparing the difference with a difference between staple lines of a healthy anastomosis at a similar time. Comparing the difference between the first distance and the second distance may include comparing the difference with a known value of a similar measurement of an anastomosis that has experienced an oral leak. Observing the first distance and the second distance may include using x-ray, MRI, CT scan, or ultrasound. Calculating the difference between the first distance and the second distance may include using a programmable device.

[0013] In some aspects, the method further includes: observing a third distance between a first staple and a second staple in the first staple line at a first time; observing a fourth distance between the first staple and the second staple at a second time; and comparing the difference between the third distance and the fourth distance with a known value of a similar measurement. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The drawings incorporated in and constituting a part of this specification illustrate embodiments of the present disclosure and, together with the general description of the present disclosure given above and the detailed description of the present disclosure given below, serve to explain the principles of the present disclosure, where:

[0015] Figure 1 is a perspective view of a surgical site before completion of an anastomosis operation;

[0016] Figure 2 is after completion of the anastomosis operation Figure 2 a perspective view of the surgical site shown in;

[0017] Figure 3A is at a first time along Figure 2 the line 3 shown in Figure 2 a cross-sectional end view of the anastomosis shown in;

[0018] Figure 3B is at a second timeFigure 3A Cross-sectional end view shown in;

[0019] Figure 3C at the third moment Figure 3A and 3B Cross-sectional end view shown in;

[0020] Figure 4 Side view of a surgical staple according to one aspect of the present disclosure;

[0021] Figure 4A is Figure 4 Enlarged view indicating the detailed area shown in;

[0022] Figure 4B is Figure 4 Top-down perspective view of another aspect of the surgical staple shown in;

[0023] Figure 5 Side view of a surgical staple according to another aspect of the present disclosure;

[0024] Figure 6 Side view of a surgical staple according to yet another aspect of the present disclosure;

[0025] Figure 7 Schematic diagram of an imaging device according to one aspect of the present disclosure;

[0026] Figure 8 Schematic diagram of an imaging device attached to a patient according to another aspect of the present disclosure;

[0027] Figure 8A is Figure 8 Enlarged view of the imaging device shown in;

[0028] Figure 9 Flowchart indicating a method for detecting anastomotic leakage according to one aspect of the present disclosure;

[0029] Figure 10A Side view of an anastomotic site at the first moment according to one aspect of the present disclosure;

[0030] Figure 10B at the second moment Figure 10A Perspective view of the anastomotic site shown in;

[0031] Figure 11A Perspective view of an anastomotic site at the first moment according to another aspect of the present disclosure; and

[0032] Figure 11B at the second moment Figure 11A Perspective view of the anastomotic site shown in. Detailed Description

[0033] Aspects of the systems and methods for detecting and / or predicting anastomotic leakage disclosed herein will now be described in detail with reference to the accompanying drawings, in which like reference numerals identify like or corresponding elements in each of the several views. As is common in the art, the term "proximal" refers to the part or component that is closer to the user or operator, such as a surgeon or clinician, and the term "distal" refers to the part or component that is farther from the user.

[0034] Figure 1 Illustrated is the joining of a first portion "O1" of a tubular organ "O" and a second portion "O2" of the tubular organ "O" in an anastomosis procedure. More specifically, the first portion "O1" of the tubular organ "O" may be secured to an anvil assembly 10, and the second portion of the tubular organ "O" is secured to the distal end of an anastomosis device such as a circular stapler 1. The anvil assembly 10 is operatively secured to a trocar member 2 extending from the distal end of the circular stapler 1. The approximation of the anvil assembly 10 relative to the distal end of the circular stapler 1 positions the first portion "O1" and the second portion "O2" of the tubular organ "O" relative to each other. Actuation of the circular stapler 1 causes a plurality of surgical staples "S" to be fired through the first portion "O1" and the second portion "O2" of the tubular organ "O" to create an anastomosis "A"( Figure 2 ).

[0035] The anastomosis "A" may comprise one or more staple lines. As shown and described throughout this disclosure, the anastomosis "A" comprises two staple lines; however, in aspects, the anastomosis "A" may comprise only a single staple line or three or more staple lines. In aspects, the staples in the first staple line are aligned with the staples in the second staple line. Alternatively, the surgical staples in the first staple line may be staggered relative to the surgical staples in the second staple line.

[0036] Various systems and methods for monitoring the condition of the anastomosis "A" of the tubular organ "O" throughout the healing process and for detecting the likelihood of an anastomotic leak and predicting a potential anastomotic leak are described below. By quantitatively analyzing the nature of the anastomosis and comparing these properties to known values of healthy anastomoses and / or known values of anastomoses that have experienced an anastomotic leak, healthcare providers can more accurately identify an anastomotic leak and / or an increased potential for anastomotic leak. Additionally, by quantitatively analyzing the anastomotic properties, healthcare providers may also be able to determine the progress of the healing process. The known values may be stored in a memory associated with the system.

[0037] One method for quantitatively analyzing anastomosis "A" is performed by observing individual staples and / or one or more staple lines. More specifically, by observing various properties, such as the relative positioning of staples of one or more staple lines after an anastomosis procedure and during the healing process, and comparing these values to known values of staples and / or staple lines in an anastomosis that heals without complications, a healthcare provider may be able to more accurately determine the condition of the anastomosis and / or more accurately predict the potential for anastomotic leakage.

[0038] Figure 3A Shows a cross-sectional view of anastomosis "A" at a first moment after an anastomosis procedure ( Figure 2 ). The first moment can be immediately after the anastomosis procedure or at any subsequent time during the healing process. The first moment can be before, during, or after peristalsis or contraction of the tubular organ "O".

[0039] As shown, anastomosis "A" includes a first or inner staple line "S1" and a second or outer staple line "S2". Although shown as having an elliptical cross-sectional shape, it is contemplated that the cross-sectional shape of the anastomosis can alternatively form a circle or other shape. At the first moment, the first staple line "S1" and the second staple line "S2" are separated by a first distance "d1" at a first position along the first staple line "S1" and the second staple line "S2", and are separated by a second distance "D1" at a second position along the first staple line "S1" and the second staple line "S2". The distance between the first staple line "S1" and the second staple line "S2" can be taken at a specific position, as shown, or the average distance between the first staple line "S1" and the second staple line "S2" can be calculated.

[0040] Quantitative analysis of anastomosis "A" can further include measuring and monitoring, for example, a third distance "Δ1" between a first staple "S 1a " and a second staple "S 1b " of the first staple line "S1" at the first moment, and / or a fourth distance "δ1" between a first staple "S 2a " and a second staple "S 2b " of the second staple line "S2" at the first moment.

[0041] Figure 3B And 3C Respectively show cross-sectional views of anastomosis "A" at a second moment and a third moment. The second moment and the third moment can be during the same phase of peristalsis and / or contraction of the tubular organ "O", at a later time, and / or during different phases of peristalsis and / or contraction of the tubular organ "O".

[0042] The distances "d2", "d3" between the first staple line "S1" and the second staple line "S2" at the first location at the corresponding second and third times, and the distances "D2", "D3" between the first staple line "S1" and the second staple line "S2" at the second location can be the same as or different from the first distance "d1" at the first location and the second distance "D1" at the second location measured at the first time. By comparing the differences between the distances "d1" and "D1" at the first time, between the distances "d2" and "D2" at the second time, and between the distances "d3" and "D3" at the third time with each other, and comparing these differences with known values of the same measurements for properly healed anastomoses and / or anastomoses experiencing anastomotic leakage, a healthcare provider can more accurately determine the current state of the anastomosis and more accurately predict the likelihood that an anastomotic leakage will occur.

[0043] The distances "Δ2", "Δ3" between the first staple "S 1a " and the second staple "S 1b " of the first staple line "S1" at the second and third times, and / or the distances "δ2", "δ3" between the first staple "S 2a " and the second staple "S 2b " of the second staple line "S2" can be the same as or different from the distance "Δ1" between the corresponding first staple "S 1a " and the second staple "S 1b " of the first staple line "S1" at the first time and the distance "δ1" between the first staple "S 2a " and the second staple "S 2b " of the second staple line "S2" at the first time. Similar to the distances "d1", "d2", "d3", "D1", "D2", "D3" between the first staple line "S1" and the second staple line "S2" at the corresponding first and second locations at the first time ( Figure 3A ), the second time ( Figure 3B ), and the third time ( Figure 3C ), respectively, the distances "Δ1", "Δ2", "Δ3" between the corresponding first staple "S Figure 3A " and the second staple "S Figure 3B " of the first staple line "S1" and the distances "δ1", "δ2", "δ3" between the first staple "S Figure 3C " and the second staple "S 1a " of the first staple line "S1" and the distances "δ1", "δ2", "δ3" between the first staple "S 1b " and the second staple "S 2a " and the second staple "S 2bThe differences in the distances “δ1”, “δ2”, and “δ3” can be compared to each other and to known values of the same measurements for properly healed anastomoses and / or anastomoses experiencing anastomotic leakage to provide a more accurate assessment of the current state of the anastomosis and / or a more accurate prediction of the probability of anastomotic leakage to a healthcare provider.

[0044] Observation of staple shedding, i.e., release of staples during the healing process, can also be used as an indicator of normal healing. An indication of normal healing can allow for earlier discharge of the patient without additional complications and reduce the overall cost of the patient's healthcare.

[0045] Figures 4 - 6 Staples configured to enhance the observation of a first staple line and a second staple line are shown. For example, in one aspect of the present disclosure, surgical staples “S′”, “S″” are coated with a ferromagnetic material “C”, such as a nanofluidic magnetic fluid or colloidal magnetic particles suspended in a fluid medium. Some surgical staples “S′” ( Figure 4 ) or all surgical staples “S″” ( Figure 5 ) may be coated with the ferromagnetic material “C” or other coatings.

[0046] Figure 4A Shown Figure 4 is the backspan “BS” of a surgical staple, including a coating divided into a plurality of sections along the longitudinal axis “X” of the backspan “BS”. In other aspects of the present disclosure, and as shown, the coating “C” includes an outer section “a”, an intermediate section “b”, and a central section “c”. Figure 4B Shown Figure 4 is the backspan “BS” of a surgical staple “S′”, including a coating “C” divided into a grid. In some aspects of the present disclosure, the coating “C” includes a first section “I”, a second section “II”, a third section “III”, and a fourth section “IV”. By dividing the coating “C” of the surgical staple “S′” into sections, any off-axis or rotational displacement of each individual surgical staple “S′” can be observed and monitored in addition to observing and monitoring the displacement of the surgical staples “S′” relative to each other.

[0047] In an alternative aspect of the present disclosure, and as Figure 6 shown, one additional magnetic bead “B” can be attached to a surgical staple “S″′” to permit external observation of the staple line. Each of the one or more magnetic beads “B” can be formed of the same or different materials and can be placed in any suitable arrangement on the backspan “BS” and / or legs of the surgical staple “S″′” to enhance the observation of the surgical staple “S″′”.

[0048] After a surgical stapling procedure, the positions of surgical staples "S" in a first staple line "S1" in tissue forming an anastomosis "A" and surgical staples "S" in a second staple line "S2" in tissue forming an anastomosis "A" are observed using known imaging techniques. For example, x-rays, MRI, CT scans, ultrasound, or other suitable imaging devices 200( Figure 7 ) may be used to observe the positions of surgical staples "S". The positions of staples "S" may be measured and recorded automatically by the imaging device 200 and / or manually by medical personnel.

[0049] As mentioned above, measurements of the positions of staples "S" relative to each other and / or of the first staple line "S1" and the second staple line "S2" relative to each other may be taken at a first time before, during, or after peristalsis or contraction of the tubular organ "O". The same measurements are then taken at a second time, and the differences between the various distances measured at the first and second times are calculated. By comparing the differences in the various distances with the differences in the various distances of known healthy and / or leaky anastomoses, a healthcare provider can more accurately determine the presence of a leak and / or the potential for a leak to occur.

[0050] Conceivably, the position of surgical staple "S" could be tracked with a GPS-like system. The GPS-like system could be located external to the patient's body, such as the superDimension TM navigation system manufactured by Medtronic of Minneapolis, MN. The system may include software and graphical user interface components resident on external hardware such as a monitor or remotely communicated devices such as a handheld or wearable device 300( Figure 8 and 8A ). The external hardware may include any suitable processor (not shown) operatively connected to a memory (not shown), which may include one or more of volatile, non-volatile, magnetic, optical, or electrical 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 may be any suitable processor (such as a control circuit) adapted to perform the operations, calculations, and / or instruction sets described in the present 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 logic processor (such as a control circuit) adapted to perform the algorithms, calculations, and / or instruction sets described herein.

[0051] The software in these devices contains algorithms that perform the following operations: quantifying and displaying the relative movement of surgical staples "S" and / or staple lines "S1", "S2" with appropriate indexing of healthy and / or anastomoses with oral leakage, such as average staple distance, average relative movement of staples and / or staple lines, average displacement, etc. If the value of the indexing exceeds and / or is below a preset level, the software can convey a warning signal to the healthcare provider indicating the need for and / or lack of further patient treatment. Values within the indexing indicate that the anastomosis has healed properly and no further treatment is required. Conceivably, monitoring of the anastomosis can be performed by the patient at home or remotely by the healthcare provider. The monitoring can be continuous or intermittent. The interval of the intermittence can increase or decrease depending on the state of the healing process and known metrics.

[0052] Figure 9 is a flow chart showing the method of monitoring anastomosis "A" described above. After the anastomosis surgery, the anastomosis "A" is observed and various properties of the surgical staples "S" and / or staple lines "S1", "S2" are recorded. At a later time, the same properties of the surgical staples "S" and / or staple lines "S1", "S2" are observed and recorded. Then the measurements from the first time and the second time are compared. Then these differences are compared with the values of the same properties of anastomoses with known characteristics, such as healthy anastomoses, anastomoses experiencing oral leakage. By comparing the measurements of anastomosis "A" with the measurements of anastomoses with known characteristics, it can be determined whether there is oral leakage and the potential for oral leakage can be predicted more accurately. Depending on the determined result, continued observation and / or treatment may be required.

[0053] Figure 10A and 10BShows another method of monitoring anastomosis "A". This method includes implanting or otherwise fixing a first set of beads "B1" to a first portion "O1" of a tubular organ "O", and implanting or otherwise fixing a second set of beads "B2" to a second portion "O2" of the tubular organ "O". The beads "b1", "b2" of the corresponding first set of beads "B1" and second set of beads "B2" can be directly implanted into the tissue layer using a known implanting device (not shown). Alternatively, the beads "b" can be sutured, adhered, or otherwise fixed to the tissue. The beads "b1", "b2" of the corresponding first set of beads "B1" and second set of beads "B2" can be implanted in a single row, in a dispersed pattern (as shown), or in any other configuration on either side of the anastomosis "A". Similar to the surgical staples "S" described above, the beads "b1", "b2" of the first set of beads "B1" and second set of beads "B2" can respectively include coatings or otherwise be configured to permit differentiation between individual beads "b1", "b2" within each of the corresponding first set of beads "B1" and second set of beads "B2" and / or between individual beads "b1" in the first set of beads "B1" and individual beads "b2" in the second set of beads "B2".

[0054] Figure 10A Shows a side view of anastomosis "A" at a first moment after an anastomosis operation. The first moment can be immediately after the anastomosis operation or at any subsequent time during the healing process. The first moment can be immediately before, during, or after the peristalsis or contraction of the tubular organ "O".

[0055] At the first moment, the first set of beads "B1" and the second first set of beads "B2" are separated by a first distance "d1" at a first position between the first set of beads "B1" and the second set of beads "B2", and are separated by a second distance "D1" at a second position between the first set of beads "B1" and the second set of beads "B2". The distance between the first set of beads "B1" and the second set "B2" can be taken at a specific position, for example, between two identified beads, or the average distance can be taken between the corresponding beads "b1", "b2" of the first set of beads "B1" and the second set of beads "B2" on each side of the anastomosis.

[0056] Continue to refer to Figure 10A , the quantitative analysis of anastomosis "A" can further include measuring and monitoring a third distance "Δ1" between a first bead "b 1a " and a second bead "b 1b " of the first set of beads "B1" at the first moment, and / or a fourth distance "δ1" between a first bead "b 2a " and a second bead "b 2b " of the second set of beads "B2" at the first moment.

[0057] Figure 10B A side view showing the anastomosis "A" at a second moment. The second moment can be during the same phase of peristalsis and / or contraction of the tubular organ "O", at a later time, and / or during a different phase of peristalsis and / or contraction of the tubular organ "O".

[0058] The distance "d2" between the first set of beads "B1" and the second set of beads "B2" at the first position at the second moment and the distance "D2" between the first set of beads "B1" and the second set of beads "B2" at the second position can be the same as or different from the first distance "d1" at the first position and the second distance "D1" at the second position measured at the first moment. By comparing the differences between the first distance "d1" and the second distance "D1" at the first moment and the distances "d2" and "D2" at the second moment with each other and with known values measured for properly healed anastomoses, the healthcare provider can more accurately determine the current state of the anastomosis and more accurately predict the likelihood that an anastomotic leak will occur.

[0059] At the second moment, the distance "Δ2" between the first bead "b 1a " and the second bead "b 1b " of the first set of beads "B1" and / or the distance "δ2" between the first bead "b 2a " and the second bead "b 2b " of the second set of beads "B2" can be the same as or different from the distance "Δ1" between the corresponding first bead "b 1a " and the second bead "b 1b " of the first set of beads "B1" and the distance "δ1" between the first bead "b 2a " and the second bead "b 2b " of the second set of beads "B2" at the first moment. Similar to the distances "d1", "d2", "D1", "D2" between the first set of beads "B1" and the second set of beads "B2" at the corresponding first position and second position at the first moment ( Figure 10A ) and the second moment ( Figure 10B ), at the first moment ( Figure 10A ) and the second moment ( Figure 10B ), the distance between the corresponding first bead "b 1a " and the second bead "b 1b " of the first set of beads "B1" and the distance between the first bead "b 2a " and the second bead "b 2bThe distances “Δ1”, “Δ2”, “δ1”, and “δ2” can be compared to each other and to known values of the same measurements in properly healed anastomoses to provide a more accurate assessment of the current state of the anastomosis to a healthcare provider and a more accurate prediction of the probability of anastomotic leak.

[0060] Another method of monitoring an anastomosis involves observing the movement of staples within a staple line during a peristaltic event to provide feedback on the condition of the anastomosis. By analyzing the rate and / or direction of movement of one staple in a first staple line relative to another staple in a second staple line and / or the rate and / or direction of movement of the first staple line and / or the second staple line during a peristaltic event, the condition of the anastomosis can be determined. Synchronous movement of the staples can indicate that the anastomosis is healing properly, while asynchronous movement of the staples can indicate improper healing, such as a tear or discontinuity in the intestine. Conceivably, an AI algorithm can be used to determine the movement pattern of the staples. Further conceivably, the movement of the staples can be observed and analyzed as a bolus of food moves through the intestine.

[0061] Figure 11A and 11B FIG. shows yet another method of monitoring anastomosis “A”. This method involves implanting a plurality of strain gauges “G” across anastomosis “A”. By measuring the strain “σ1” experienced in the plurality of strain gauges “G” at a first moment ( Figure 11A ) and / or the strain “σ2” experienced in the plurality of strain gauges “G” at a second moment, and comparing the strains “σ1”, “σ2” to each other, or to known strains exhibited in properly healed anastomoses and / or anastomoses experiencing anastomotic leak, a more accurate assessment of the current state of the anastomosis, and / or a more accurate prediction of the probability of anastomotic leak is possible.

[0062] The strains “σ1”, “σ2” experienced in the plurality of strain gauges “G” at the first moment and the second moment ( Figure 11A 、 Figure 11B ) respectively can be a comparison of individual strain gauges “g” and / or an average or median strain of some or all of the strain gauges “g” in the plurality of strain gauges “G”. As detailed above regarding the differences between surgical staples “S” and / or staple lines “S1”, “S2” at a first moment and subsequent moments, the differences in strain at the first moment and the second moment can be compared to known values of healthy and / or anastomotic leak anastomoses, and measures can be taken accordingly.

[0063] Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the present disclosure is not limited to those exact embodiments, and that various other changes and modifications may be made therein by those skilled in the art without departing from the scope or spirit of the present disclosure.

Claims

1. A system for monitoring anastomotic healing throughout the healing process, the system comprising: an imaging device configured to observe a first distance at a first location between a first staple line and a second staple line in tissue forming an anastomosis at a first moment, and a second distance at the first location at a second moment; and a programmable device configured to calculate a difference between the first distance and the second distance and compare the difference with known values of healthy anastomoses and / or known values of anastomoses experiencing anastomotic leakage.

2. The system according to claim 1, wherein the imaging device is configured to observe a distance between a first staple and a second staple within the first staple line.

3. The system according to claim 1, wherein the programmable device is configured to be worn by a patient.

4. The system according to claim 1, wherein the staples within the first staple line comprise a first coating.

5. The system according to claim 4, wherein the staples within the second staple line comprise a second coating different from the first coating.

6. The system according to claim 1, wherein the staples within the first staple line comprise at least one bead fixed thereto.

7. The system according to claim 1, wherein the imaging device uses at least one of x-ray, MRI, CT scan, or ultrasound.

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