ABDOMINAL MODEL FOR LAPAROSCOPIC ABDOMINAL WALL REPAIR/RECONSTRUCTION SIMULATION
20170352295 · 2017-12-07
Inventors
- Tristan Belzacq (Trevoux, FR)
- Frederic Turquier (Saint Cyr au Mont d'Or, FR)
- Anthony Vegleur (Milhaud, FR)
Cpc classification
H04N7/181
ELECTRICITY
G09B23/285
PHYSICS
International classification
H04N7/18
ELECTRICITY
Abstract
A physical abdominal surgical simulation system including an abdominal model mimicking the biomechanical properties and response of a patient specific abdomen and an image acquisition and analysis system. The abdominal model includes an abdominal wall model insert forming a frame of the abdominal model, an abdominal wall member secured to the abdominal wall model insert, a back member secured to the abdominal wall model insert in opposed relation with respect to the abdominal wall member, and an abdominal model cavity defined within abdominal wall model insert, the abdominal wall member, and the back member. The image acquisition and analysis system includes a plurality of cameras configured to capture images of the abdominal model cavity.
Claims
1. A physical abdominal surgical simulation system comprising: an abdominal model mimicking a patient specific abdomen, the abdominal model including: an abdominal wall model insert forming a frame of the abdominal model; an abdominal wall member having biomechanical properties mimicking the biomechanical response of the patient specific abdomen, the abdominal wall member secured to the abdominal wall model insert; a back member secured to the abdominal wall model insert in opposed relation with respect to the abdominal wall member; and an abdominal model cavity defined within abdominal wall model insert, the abdominal wall member, and the back member; and an image acquisition and analysis system including a plurality of cameras configured to capture images of the abdominal model cavity.
2. The system according to claim 1, wherein the abdominal wall model insert includes at least one of a ribcage member, a spinal column member, a pelvis member, or a lateral abdominal wall member.
3. The system according to claim 2, wherein the ribcage member has a height, a length, and a width mimicking a height, a length, and a width, respectively, from a sternum to a lowest floating rib of the patient specific abdomen.
4. The system according to claim 2, wherein the pelvis member includes a height, a length, and a width mimicking a height, a length, and a width, respectively, from a pubis bone to at least one of a left iliac crest or a right iliac crest of the patient specific abdomen.
5. The system according to claim 2, wherein the lateral abdominal wall includes a height mimicking a height of at least one of a right lateral abdominal wall or a left lateral abdominal wall of the patient specific abdomen.
6. The system according to claim 1, wherein the abdominal model further includes a plurality of opening defined in at least one of the abdominal wall model insert, the abdominal wall member, or the back member.
7. The system according to claim 1, wherein the back member is formed from a transparent material.
8. The system according to claim 7, wherein the plurality of cameras are positioned outside of the abdominal model and facing the back member.
9. The system according to claim 1, further including an insufflation source in fluid communication with the abdominal model cavity.
10. The system according to claim 1, further including at least one sensor disposed within the abdominal model cavity.
11. The system according to claim 6, further including at least one of an access device or a surgical instrument positioned through an opening of the plurality of openings.
12. The system according to claim 11, wherein the access device or the surgical instrument is a SILS™ port, a hand port, a gel port, or a trocar.
13. The system according to claim 1, further comprising at least one surgical implant disposed within the abdominal model cavity of the abdominal model.
14. The system according to claim 13, wherein the at least one surgical implant is secured to an inner surface of the abdominal wall member.
15. The system according to claim 13, wherein the at least one surgical implant is selected from the group consisting of textile-based implants, tissue fixation devices, and combinations thereof.
16. The system according to claim 1, wherein the image acquisition and analysis system further includes a plurality of markers configured to be tracked by the plurality of cameras, the plurality of cameras configured to capture images of the plurality of markers.
17. The system according to claim 16, wherein the plurality of markers are disposed within the abdominal model cavity of the abdominal model.
18. The system according to claim 1, wherein the image acquisition and analysis system further includes image processing software.
19. A method of simulating a laparoscopic surgical procedure in a physical abdominal model mimicking an abdomen of a patient, the method comprising: insufflating an abdominal wall member of an abdominal model to a first inflated state; securing at least one surgical implant to an inner surface of the abdominal wall member of the abdominal model; capturing a first set of images of the at least one surgical implant in the first inflated state; deflating the abdominal wall member of the abdominal model to a deflated state; and capturing a first set of images of the at least one surgical implant in the deflated state.
20. The method according to claim 19, further comprising comparing the first sets of images of the at least one surgical implant in the first inflated state and the deflated state.
21. The method according to claim 20, further comprising: inflating the abdominal wall member of the abdominal model to a second inflated state; re-securing the at least one surgical implant on the inner surface of the abdominal wall member of the abdominal model; capturing a second set of images of the at least one surgical implant in the second inflated state; deflating the abdominal wall member of the abdominal model to the deflated state; and capturing a second set of images of the at least one surgical implant in the deflated state.
22. The method according to claim 21, further comprising comparing the first and second sets of images of the at least one surgical implant.
23. The method according to claim 22, wherein re-securing the at least one surgical implant includes varying at least one of placement of the at least one surgical implant, fixation distribution of the at least one surgical implant, fixation modality of the at least one surgical implant, or selection of the at least one surgical implant, and comparing the first and second sets of images includes analyzing at least one physical output based on the variation.
24. The method according to claim 19, wherein at least one marker is disposed on the at least one surgical implant, and capturing the first sets of images of the at least one surgical implant in the inflated and defected states includes capturing the position of the at least one marker.
25. An abdominal model mimicking a patient specific abdomen, the abdominal model comprising: an abdominal wall model insert forming a frame of the abdominal model; an abdominal wall member made from an expandable material and having biomechanical properties mimicking the patient specific abdomen, the abdominal wall member secured to the abdominal wall model insert; a back member secured to the abdominal wall model insert in opposed relation with respect to the abdominal wall member; and an abdominal model cavity defined within abdominal wall model insert, the abdominal wall member, and the back member.
26. The abdominal model according to claim 25, wherein the abdominal wall model insert comprises a ribcage member, a pelvis member, and a lateral abdominal wall member.
27. The abdominal model according to claim 26, further comprising a plurality of openings defined in at least one of the abdominal wall model insert, the abdominal wall member, or the back member.
28. The abdominal model according to claim 27, wherein the plurality of openings are defined within the abdominal wall model insert.
29. The abdominal model according to claim 25, wherein the back member is formed from a transparent material.
30. The abdominal model according to claim 25, further including a plurality of legs extending from the frame and supporting the abdominal model.
31. The abdominal model according to claim 25, wherein the abdominal wall member is free of an abdominal defect.
32. The abdominal model according to claim 25, wherein abdominal wall member includes an inner and outer surface, wherein the inner surface is configured to secure at least one surgical implant thereto.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Embodiments of the presently disclosed systems, devices, and methods are described herein with reference to the drawings, wherein:
[0015]
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[0025] Corresponding reference characters indicate corresponding parts throughout the drawings.
DETAILED DESCRIPTION
[0026] For the purposes of discussion, the systems, devices, and methods for modeling an abdomen and simulating a laparoscopic surgical procedure will be described with respect to an abdominal model including an abdominal wall member, with or without an abdominal wall member defect, and simulating an abdominal wall reinforcement procedure. The abdominal model is configured to simulate a passive anesthetized abdominal wall during a hernia repair procedure, and to assess the impact of simulated celioscopic intra-abdominal pressure on the hernia repair procedure.
[0027] It should be understood, however, that the presently disclosed systems, devices, and methods may be utilized to model the physical structures/properties of an abdomen of any patient undergoing a laparoscopic surgical repair/reconstruction procedure including, for example, abdominal wall hernia repair (defect-closed/augmentation, defect-non-closed/bridging), component separation procedures (e.g., transversus abdominis muscle release), and general tissue resection. The abdominal model may be used with any surgical implants utilized during a laparoscopic surgical procedure including, for example, textile-based implant (e.g., a surgical mesh) and/or tissue fixation devices (e.g., sutures, tacks, staples, adhesives), as well as any surgical/medical devices associated with the performance of the laparoscopic surgical procedure (e.g., access devices (such as SILS™ ports, hand ports, gel ports, etc.), trocars, insufflation needles, laparoscopes, surgical instruments, etc.).
[0028] The simulated laparoscopic surgical procedure may be designed to include a desired surgical technique and desired surgical/medical devices and/or surgical implants to be utilized with the surgical technique, and to provide desired physical outputs. For example, if an abdominal wall reinforcement procedure is performed with a textile-based implant, the overlap of the textile-based implant on an abdominal wall member of an abdominal model may be a desired observed physical output. As another example, if a defect closure procedure is performed, the tissue fixation device modalities may be the desired observed physical outputs. Additionally, the simulated laparoscopic surgical procedure may be performed directly by a clinician (e.g., a surgeon) or by remote operation via a robotic surgical system.
[0029] Referring now to
[0030] The abdominal model 100 is a physical model used to simulate an abdomen of a patient. The abdominal model 100 is personalized to mimic physical structures, environments, and/or physical behaviors of a patient specific abdomen. Physical parameters of the structures and/or environments can be made and/or calibrated to mimic one or more specific physical behaviors of the patient specific abdomen, such as biomechanical and/or thermo-mechanical behaviors, and/or to mimic the physical relationships between physical parameters related to the physical behaviors of the patient specific abdomen, such as the abdominal wall inflation or deflation during changes in intra-abdominal pressure.
[0031] An abdomen “A” of a patient is shown, for example, in
[0032] As shown in
[0033] As referred to herein, an abdominal wall model insert 101 includes one or more of the ribcage member 104, the pelvis member 108, and/or the lateral abdominal wall member 112, and a back member 114 (
[0034] Physical parameters, such as the anatomy (e.g., size, thickness, and/or geometry) of one or more of the structures of the abdomen “A” (
[0035] As shown in
[0036] It is envisioned that the respective heights, lengths, and/or widths described herein on the left side of the abdominal wall model may or may not be symmetrical to the heights, lengths, and/or widths described herein on the right side of the abdominal wall model.
[0037] Other physical parameters, such as the material parameters of one or more of the structures of the abdomen “A” (
[0038] The abdominal wall member 110 may be formed from material(s) that mimics the abdominal wall “W” (
[0039] The abdominal wall model insert 101 (e.g., one or more of the ribcage member 104, the pelvis member 108, and/or the lateral abdominal wall member 112), the abdominal viscera member (not shown), and/or the back member 114 (
[0040] In embodiments, the abdominal wall model insert 101 may be a boundary condition mimicking the attachment of the abdominal wall “W” (
[0041] The abdominal wall model defect (not shown) is any lack of structure in the abdominal wall member 110 that mimics a defect in and/or through at least a portion of a thickness of the abdominal wall “W” (
[0042] The abdominal model cavity 102 is a chamber that may or may not contain the abdominal viscera member (not shown) and is delimited by the abdominal wall member 110, the abdominal model insert 101, and the back member 114. Environmental parameters of the abdominal cavity “C” (
[0043] Referring again to
[0044] The abdominal wall member 110 and the back member 114 are secured to opposite sides of the abdominal wall model insert 101 in a fluid tight manner to define the abdominal model cavity 102 therein. In a laparoscopic approach, the abdominal surgical procedure is conducted when the abdominal wall is inflated, increasing intra-abdominal pressure and separating the viscera from the abdominal wall to create a workspace. Accordingly, in the abdominal model 100, the abdominal wall member 110 is inflated by air insufflation in the abdominal model cavity 102 and thus, the abdominal model cavity 102 is a closed system that is airtight.
[0045] A plurality of openings 124 is defined in one or more components of the abdominal wall model insert 101, such as the ribcage, pelvis, and lateral abdominal wall members 104, 108, and 112, respectively. The openings 124 act as pathways for accessing the abdominal model cavity 102 to, for example, insufflate, pressurize, and/or monitor conditions within the abdominal model cavity 102, and reach structures lying therein (e.g., an inner surface 110a of the abdominal wall member 110). In embodiments, the abdominal wall model insert 101 includes at least four openings 124, and in some embodiments, at least one opening 124 is provided in each of four parts (e.g., the ribcage and pelvis members 104, 108) defining the abdominal wall model insert 101. In embodiments, the abdominal wall model insert 101 includes at least six openings 124, and in some embodiments, the abdominal wall model insert 101 includes at least twelve openings 124. The use of multiple pre-formed openings 124 aid in quicker experiment set-up and ease of use for analytical purposes. Access devices/trocars 126 may be positioned within one or more of the plurality of openings 124 for passage of surgical/medical devices and/or surgical implants required for a desired laparoscopic surgical procedure therethrough.
[0046] In embodiments, the plurality of openings 124 may be pre-formed in one or more components of the abdominal wall model insert 101, such as the ribcage, pelvis, and lateral abdominal wall members 104, 108, and 112, respectively. In such embodiments, it should be understood that any un-used openings 124 can be plugged/blocked to maintain the fluid tight environment of the abdominal model cavity 102.
[0047] As further shown in
[0048] While the plurality of openings 124 are shown as being defined in the abdominal wall model insert 101, it should be understood that other locations are contemplated depending on the laparoscopic surgical procedure to be simulated. For example, the abdominal wall member 110 and/or the back member 114 may include openings for accessing the abdominal model cavity 102. The abdominal model 100 is also shown with the abdominal wall member 110 facing downwards to mimic a patient in a prone position. However, it should be understood that the abdominal model 100 may be oriented in other positions, such as with the abdominal wall member 110 facing upwards to mimic a patient in a supine position, as shown, for example, in
[0049] With reference to
[0050] The markers 220 are secured to a surgical implant 300 (e.g., a textile-based implant) at the overlap boundary of the surgical implant 300 with the inner surface 110a of the abdominal wall member 110, and coincide with the fixation points of the surgical implant 300 to the abdominal wall member 110. It should be understood that the markers 220 may be secured to any portion of the abdominal model 100 and/or surgical implant(s) 300, depending on the desired physical outputs, and the cameras 210 are likewise positioned to track the markers 220.
[0051] The speckled layers 222a , 222b are disposed on or formed as part of the inner and/or outer surfaces 110a , 110b of the abdominal wall member 110. The speckled layers 222a , 222b are patterned and/or textured areas that may extend across the entirety of the inner and outer surfaces 110a , 110b of the abdominal wall member 110, or a portion thereof depending on the desired physical outputs (e.g., a portion of the inner surface 110a of the abdominal wall member 110 to which a surgical implant 300 is attached may include the speckled layer 222a). The cameras 210 are positioned to track the speckled layers 222a , 222b.
[0052] The image processing hardware and software 230, 232 are used to process the images acquired by the cameras 210. The image processing software 232 analyzes the position of the markers 220 and/or the speckled layers 222a , 222b in a 3D coordinate system, and measures, for example, shape, contour, movement, displacement, deformation, strain, etc. The image processing software 232 visually and/or numerically displays data to allow the clinician to view, for example, the physical outputs and/or the differences between physical inputs and outputs of the simulated laparoscopic surgical procedure on the abdominal model 100.
[0053] Examples of physical outputs which could be measured include the defect geometry of the abdominal wall member in a deflated state. This physical output could be deducted from the position and displacement field of the inner and/or outer speckled layers of the abdominal wall member calculated in the deflated state. As another example, the fixation modalities at the deflated state could also be deducted from the strain field close to the fixation points calculated on the inner and/or outer surfaces of the abdominal wall member, which include the speckled layers, in the deflated state.
[0054] Any physical output of interest can be calculated using the image acquisition and analysis system 200 and/or external enabling tools. For example, the bulging and shear forces distribution at the fixation points of a textile-based implant could be assessed experimentally or numerically. For a detailed description of exemplary models for making such calculations, reference may be made to European Patent Application Nos. 14306543 and 16305341, the entire contents of each of which are hereby incorporated by reference herein.
[0055] Subsequent simulated laparoscopic surgical procedure(s) may be performed with modifications to, for example, the placement of the surgical implant, the fixation distribution and/or fixation modality of the surgical implant, the conditions in which the procedure is performed (e.g., a change in intra-abdominal model pressure at the inflated state), and/or the selection of the surgical implant used (e.g., utilizing a different surgical implant having different performance characteristics and/or size), depending upon the observed physical outputs of the first simulated laparoscopic surgical procedure and the desired physical outputs of the procedure. The physical outputs of the simulated laparoscopic surgical procedures may be compared to each other to assess the effects of the variation(s) and, if desired, further modifications and simulations may be performed. Additionally, qualitative performance characteristics, such as folding, buckling, puckering etc. of the surgical implant, may also be observed by the clinician.
EXAMPLES
Example 1
Patient Specific Abdominal Model
[0056] An abdominal model was designed to mimic the abdominal structures of a patient in need of an abdominal wall reinforcement procedure. The modeled abdominal structures, physical structures utilized in the abdominal model, and physical parameters of the physical structures of the abdominal model are listed in Table 1 below.
TABLE-US-00001 TABLE 1 Set-up of a patient specific abdominal model Physical Modeled Abdominal Structure Structure/Environment Physical Parameters Abdominal wall member Flat 8 mm thick Longitudinal radius of curvature of the silicon structure outer surface Transversal radius of curvature of the outer surface Abdominal wall member defect Not materialized Abdominal wall model insert 3 mm thick steel Length “pubis bone—sternum” structure (“L3” (FIG. 3C)) Length “pubis bone—iliac crest” (“L2” = “L5” (FIG. 3C)) Length “sternum—floating rib” (“L1” = “L4” (FIG. 3C)) Height “pubis bone—sternum” (“H0” (FIG. 3A)) Height “pubis bone—iliac crest” (“H2” = “H5” (FIGS. 3A and 3D) Height “sternum—floating rib” (“H1” = “H4” (FIGS. 3A and 3D)) Width “pubis bone—iliac crest” Width “sternum—floating rib” (“W1” = “W2” = “W3” = “W4” (FIG. 3C)) Height “lateral abdominal wall” (“H3” = “H6” (FIGS. 3A and 3D)) Abdominal viscera member Not materialized Back member Flat 4 mm thick Plexiglas structure Abdominal model cavity Air tight chamber Deflexion (increase of cavity volume) Intra-abdominal model pressure
[0057] The physical parameters of the abdominal wall member and the abdominal model cavity provided in Table 1 above were calibrated so that the biomechanical behavior of the abdominal wall member during inflation mimicked the biomechanical behavior of the patient's abdominal wall during inflation, as shown in
[0058] The physical parameters of the abdominal model listed in Table 2 below were calibrated and held constant, and the physical parameters listed in Table 3, also below, were not calibrated.
TABLE-US-00002 TABLE 2 Abdominal model—physical parameters calibrated remaining constant Physical Parameters Value Length “pubis bone—sternum” 400 mm (“L3” (FIG. 3C)) Length “pubis bone—iliac crest” 170 mm (“L2” = “L5” (FIG. 3C)) Length “sternum—floating rib” 170 mm (“L1” = “L4” (FIG. 3C)) Height “pubis bone—sternum” 0 mm (“H0” (FIG. 3A)) Height “pubis bone—iliac crest” 70 mm (“H2” = “H5” (FIGS. 3A and 3D) Height “sternum—floating rib” 70 mm (“H1” = “H4” (FIGS. 3A and 3D)) Width “pubis bone—iliac crest” 400 mm Width “sternum—floating rib” (“W1” = “W2” = “W3” = “W4” (FIG. 3C))
TABLE-US-00003 TABLE 3 Abdominal model—physical parameters not calibrated Physical Parameters Value Height “lateral abdominal wall” 80 mm (“H3” = “H6” (FIGS. 3A and 3D))
Example 2
Laparoscopic Surgical Procedure Simulated on an Abdominal Model
[0059] The abdominal model of Example 1 was set-up for the simulation of a laparoscopic Intra-Peritoneal Onlay Mesh (IPOM) repair procedure. The simulation was designed to assess the physical outputs of a textile-based implant during an abdominal wall reinforcement procedure conducted using a laparoscopic approach to fix the textile-based implant to the inner surface of the abdominal wall member. The surgical procedure, including the technique, surgical/medical devices and implants used, as well as the desired physical outputs are provided in Table 4 below.
TABLE-US-00004 TABLE 4 Parameters of surgical procedure simulation Technique Surgical/Medical Devices/Implants Physical inputs/outputs Laparoscopic Intra-Peritoneal Textile-based implant: Symbotex ™ Fixation distribution Onlay Mesh Composite Mesh, 20 cm × 15 cm (graphic) Target: textile-based implant Fixation Means: Protack ™ Fixation Fixation distribution conformity at the inflated state Device (parameters) Clamps: EndoGrasp ™ Textile-based implant Access Devices: Sils ™ Port conformity with respect to the inner surface of the abdominal wall member
[0060] The surgical procedure simulation was conducted on the abdominal model with the abdominal wall member facing downwards to mimic a patient lying in a prone position (see e.g.,
TABLE-US-00005 TABLE 5 Physical outputs of a textile-based implant at an inflated state Physical inputs/outputs Physical inputs—Inflated state (5 mmHg) Fixation distribution Simple circle crown: parameters 10 mm from the edge of the textile-based implant Equal fixation distance apart from each other set to 16 mm Fixation distribution See FIG. 5A graphic
[0061] The abdominal wall member was then deflated to a deflated state upon completion of the surgical procedure simulation. The physical outputs at the deflated state are given in Table 6 below, as well as in
[0062] The fixation distribution of the textile-based implant at the deflated state was deducted from the position and the displacement of the markers located at the fixation points, and calculated on the layout of the inner surface of the abdominal wall member in the deflated state using a two camera acquisition system and 3D digital image correlation software by VIC-3D™. The 2D coordinate of fixation points was calculated using an arc length calculation between the fixation points along the inner surface of the abdominal wall member, both in the longitudinal and transversal directions, in both the inflated and deflated states.
TABLE-US-00006 TABLE 6 Physical outputs of a textile-based implant at a deflated state Physical inputs/outputs Physical outputs—Deflated State Fixation distribution Simple circle crown: parameters 10 mm from the edge of the textile-based implant Equal fixation distance apart from each other set to 12 mm Fixation distribution See FIG. 6A graphic
[0063] Shifts between the physical inputs and outputs at the inflated and deflated states, respectively, are provided in Table 7 below, as well as in
TABLE-US-00007 TABLE 7 Shift between the physical inputs and outputs Shift between the physical inputs (at the inflated state) and the physical outputs Physical inputs/outputs (at the deflated state) Fixation distribution graphic See FIG. 7 Layover of the textile-based Longitudinal direction: L.sub.Inflated state.sup.Longitudinal − L.sub.Deflated state.sup.Longitudinal ≈ 30 mm implant Transversal direction: L.sub.Inflated state.sup.Transversal − L.sub.Deflated state.sup.Transversal ≈ 20 mm
[0064] While embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.