Traction device and method of use

Abstract

Trocar retractor devices and methods of use are described, where a device for positioning an instrument can generally include a base plate having a first surface and a second surface opposite the first surface, an instrument positioning guide protruding from the first surface of the base plate, and one or more suction assemblies positioned along the second surface and in fluid communication with an interior of the base plate. The one or more suction assemblies can be attachable to a region of tissue via a vacuum force applied by the one or more suction assemblies. The device can also cause the base plate to be configured to maintain a predetermined configuration upon application of the vacuum force.

Description

[0001] Cross Reference to Related Applications

[0002] This application is a continuation of U.S. Application No. 16 / 993,779, filed August 14, 2020, and is also a continuation of U.S. Application No. 16 / 993,849, filed August 14, 2020, both of which claim priority to U.S. Provisional Application No. 62 / 948,050, filed December 13, 2019, each of which is incorporated by reference herein in its entirety. TECHNICAL FIELD

[0003] The present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices and methods for positioning a trocar device and a tissue region. BACKGROUND

[0005] Trocars are commonly used in surgical procedures, such as laparoscopic surgery, to penetrate a surface of the skin to access an internal body cavity. Generally, a trocar includes an obturator, which can be blunt or sharp, through which a cannula can be inserted. By penetrating the surface of the skin and inserting the trocar into a body cavity, such as the abdominal cavity, the obturator can be removed from the cannula, leaving a passageway through the cannula and into the body cavity. Unfortunately, trocars often do not provide any indication to the user of the depth of penetration of the trocar, which the user must estimate during and after penetration of the abdominal wall.

[0006] Furthermore, trocar insertion can cause perforation injuries to underlying organs or structures, resulting in medical complications. For example, laparoscopic intra-abdominal trocar insertion can cause injury to underlying intestines or bleeding from various blood vessels. The tendency of tissue to collapse or cave in around the trocar when the trocar is inserted into the tissue further complicates the situation.

[0007] To reduce the incidence of accidental perforation, surgeons can establish a pneumoperitoneum by blowing gas into the abdomen to enlarge the space between the interior of the abdominal wall and the underlying internal organs, intending to provide space for the trocar to penetrate the abdominal wall and penetrate above the organs. Pneumoperitoneum is typically established by using a Veress needle, which is used to penetrate the abdominal cavity and deliver gas, but which also has the same potential complications as trocar insertion.

[0008] Once penetration of the body wall is achieved, the obturator can be removed, leaving the cannula penetrating the body, which is adapted to receive any number of surgical instruments. However, the guide tube can experience unintentional or undesirable movement, such as a change in penetration depth or accidentally withdrawing from the body.

[0009] Accordingly, there is a need for a blow / trocar device that can be safely inserted into a patient and reduce the risk of damage to underlying tissue. There is also a need for a device that allows for the positioning and traction of a tissue region during a surgical procedure without the risk of damage or unintentional movement. SUMMARY

[0011] A variation of the trocar positioning platform can also be used for tissue traction or positioning. The positioning platform can include a base plate having a first side and a second side, a trocar positioning guide can extend on the first side, the second side configured to apply a releasable vacuum through one or more suction openings that can adhere to a tissue surface for temporary fixation. A pump or negative pressure mechanism positioned away from the base plate can be fluidly coupled to the base plate through one or more fluid lines to provide the vacuum force. The one or more suction openings can be distributed on the base plate in a uniform manner, in an arbitrary manner, or in any number of predetermined designated configurations. The one or more suction openings can each define a chamber that is limited by a single suction assembly. While the number of suction openings can vary from one opening to a plurality of openings, one variation of the base plate can include, for example, 21 suction openings to 25 suction openings.

[0012] The base plate can be formed to have any of a variety of configurations (e.g., circular, elliptical, rectangular, pentagonal, hexagonal, octagonal, etc.) so long as the base plate can be positioned on a target tissue region as desired. While the base plate can be formed in a number of different configurations, the illustrated variation can include a first flexible layer and a second flexible layer positioned opposite the first layer such that a fixation layer is formed between the first flexible layer and the second flexible layer, and the first layer and the second layer are free to slide relative to one another. The first layer and the second layer can be fixed or otherwise sealed to one another about their perimeters such that the fixation layer formed therebetween forms an airtight chamber in fluid communication with each of the one or more suction openings. The fixation layer can be completely or at least partially filled with a means to limit the sliding movement between the first layer and the second layer, such as a screen, mesh, bead, groove, channel transverse or angled relative to one another, protrusions on opposing surfaces, etc., or any substance or feature that increases the frictional resistance between the first layer and the second layer. In the case where a mesh layer is used as the fixation layer, there is no minimum thickness or porosity that the mesh can have so long as the mesh provides sufficient frictional resistance to movement between the first layer and the second layer when collapsed due to the vacuum force.

[0013] During the initial positioning of the substrate against the tissue region, the first and second layers can be free to slide relative to each other and relative to the fixed layer, allowing the substrate to conform to the anatomy of the underlying adhered tissue. Once a vacuum force, such as 600 to 650 mm Hg, is applied through the substrate via the fluidly coupled vacuum line, the one or more suction openings can attach to the underlying tissue due to the negative pressure, and the first and second layers can collapse on or toward each other. The presence of the fixed layer can increase the frictional resistance between the contacting inner surfaces of the first and second layers against each other and against the fixed layer, such that the substrate can be frozen in its reconfigured shape. If the substrate is reconfigured to conform to the anatomy of the underlying tissue or is reconfigured into another shape, the application of negative pressure can collapse the first and second layers such that the substrate can maintain its configuration during the application of the vacuum. If the substrate is adhered against the underlying tissue in a flat configuration, the application of negative pressure can collapse the first and second layers such that the flat configuration is maintained. Once the vacuum force is released or the pressure is increased, the first and second layers can release from each other and from the fixed layer, enabling the substrate to be released from the tissue and return to its flexible shape in order to be removed or attached to the tissue or another region of the tissue.

[0014] The substrate can further define one or more channels or openings that can extend from the perimeter of the substrate toward the insufflation / trocar positioning guide to further provide flexibility of the substrate. Additionally, the trocar positioning guide can protrude from the substrate, such as laterally or at an angle relative to the substrate, such that the positioning guide includes a trocar channel that defines a cavity through the substrate to allow a trocar to pass through and into the underlying tissue. The positioning guide can also have a shoulder that protrudes radially from a proximal portion of the trocar channel that provides a handle to facilitate user manipulation and adjustment of the positioning guide and substrate, and also facilitates trocar insertion into the trocar channel. The trocar channel can also define an opening or slit along the channel to provide for angled positioning of the trocar relative to the substrate and trocar positioning guide in a controlled manner. Thus, the width of the opening or slit along the trocar channel can have the same or slightly larger dimension as the diameter of the trocar itself. Additionally, there can be multiple interchangeable guides for specific applications or procedures to improve access or traction, such as for tissue positioning, insufflation, trocar placement, or fascia closure.

[0015] In one usage example, the platform can be positioned above the target tissue area to be treated, and one or more aspiration openings can be positioned to contact the tissue, such as the skin surface, with the positioning guide protruding away from the skin surface. Vacuum force can be activated via a pump fluidly connected to one or more fluid lines and applied through the substrate, causing the one or more aspiration openings to create adhesion to secure the substrate to the skin surface. The substrate can be positioned to ensure that the openings of the positioning guide are directly aligned with the portion of the tissue to be punctured by the cannula.

[0016] With the positioning platform positioned in this manner, the cannula can be advanced through the positioning guide and toward the tissue area to be accessed by the insertion force applied to the cannula. Simultaneously, a reaction force can be applied directly to the positioning guide in the opposite direction to the insertion force. When tissue is attached to one or more aspiration openings, and due to the reaction force applied from the cannula in the opposite direction to the insertion force, the tissue can be maintained in a relatively neutral state as the cannula penetrates the skin surface and is further inserted into the tissue. That is, when the cannula is initially inserted and advanced into the tissue, further indentation or collapse of the tissue can be prevented. This further prevents unintentional insertion, damage, or abrasion of tissue structures during cannula insertion. After the cannula is inserted into the tissue, the vacuum level can be selectively reduced relative to the initial level.

[0017] Another variation of the positioning platform can utilize a substrate formed of any number of biocompatible flexible materials (e.g., polyethylene, polyvinyl chloride, silicone, etc.), configured to have an adhesive surface for temporary fixation to the skin surface. With the positioning guide extending from the first surface, a second surface can be coated or injected with any number of biocompatible agents or adhesives (e.g., acrylates, cyanoacrylates, silicone, polyurethane, epoxy, etc.) that can temporarily attach the second surface to the tissue surface. While the substrate can be attached without the vacuum force that causes the substrate layers to collapse to maintain shape or configuration, once attached, the substrate can still be used to traction tissue and to reconfigure tissue, for example, by manually reconfiguring the tissue area. Furthermore, this variation can optionally incorporate a pivotable or repositionable positioning guide to the substrate.

[0018] Another variation utilizes a handle fixed to the first side of the substrate. This variation omits the cannula positioning guide and opening, allowing the positioning platform to function as a tissue retractor or manipulator once the substrate is attached to the tissue surface. The handle can be configured to allow the user to manipulate the substrate to any number of various positions.

[0019] Another variation may have a substrate including a handle projecting from a first side of the substrate. A second surface of the substrate may be configured with, for example (as described herein), an adhesive for temporary attachment to a tissue surface. The interior of the substrate may be filled with a particulate material (e.g., beads made of any kind of material, such as plastics, polymers, etc.), which is free to move relative to each other and contained between the first and second layers of the substrate. The beads are free to move internally before collapsing due to vacuum forces, allowing the substrate to conform to the anatomical structure when placed on the tissue surface. Once the substrate is attached to the tissue surface in its unconstrained configuration (where the beads are free to move), the substrate can be reconfigured by manipulating the handle, for example, to traction a target tissue area. A vacuum force can be applied to the interior of the substrate while maintaining the handle in its reconfigured shape until the layers collapse into abutment against each other and onto the contained beads. The beads can collapse into abutment, increasing frictional resistance and forcing the substrate to maintain its reconfigured shape, and also forcing the attached tissue to maintain the same reconfigured shape, for example, remaining in traction. Once the vacuum force is removed and air is allowed to re-enter the interior of the substrate, the substrate can relax its shape and allow the attached tissue to flatten or return to its initial shape.

[0020] A variation of the device for positioning an instrument may generally include a substrate having a first surface and a second surface opposite to the first surface, an instrument positioning guide projecting from the first surface of the substrate, and one or more suction assemblies positioned along the second surface and in fluid communication with the interior of the substrate, wherein one or more suction assemblies may be attached to a tissue region via a vacuum force applied by the one or more suction assemblies. The device may allow the substrate to be configured to maintain a predetermined configuration when a vacuum force is applied.

[0021] A variation of the method for positioning the device may generally include: positioning a second surface of the substrate near a tissue surface, wherein the second surface is opposite to a first surface of the substrate; attaching one or more suction components positioned along the second surface to the tissue surface via a vacuum force applied by one or more suction components, wherein one or more suction components are in fluid communication with the interior of the substrate, thereby advancing the device through or along a device positioning guide protruding from the first surface of the substrate and into the tissue surface; and applying a reaction force to the substrate while advancing the device into the tissue surface.

[0022] Another variation of the method for positioning the device may generally include: positioning a second surface of the substrate near a tissue surface, wherein the second surface is opposite to a first surface of the substrate; attaching one or more suction components positioned along the second surface to the tissue surface via a vacuum force applied by one or more suction components, wherein one or more suction components are in fluid communication with the interior of the substrate; reconfiguring the shape of the substrate while attaching the tissue surface to one or more suction components such that the tissue surface is reconfigured accordingly; advancing the device through or along a device positioning guide protruding from the first surface of the substrate into the tissue surface; and applying a reaction force to the substrate while advancing the device into the tissue surface.

[0023] Another device for traction of a tissue region may generally include a substrate having a first surface and a second surface opposite to the first surface, one or more suction components positioned along the second surface and in fluid communication with the interior of the substrate, one or more suction components being attached to the tissue region via a vacuum force applied by one or more suction components, and wherein the substrate is configured to maintain a predetermined configuration when a vacuum force is applied.

[0024] Another method of positioning an instrument may generally include: positioning a second surface of a substrate near a tissue surface, wherein the second surface is opposite to a first surface of the substrate; attaching one or more suction components positioned along the second surface to the tissue surface via a vacuum force applied by one or more suction components, wherein one or more suction components are in fluid communication with the interior of the substrate; and maintaining a first configuration of the substrate via the vacuum force such that the attached tissue surface conforms to the first configuration.

[0025] For all embodiments, the required vacuum level may vary depending on the procedure. For example, a higher vacuum level may be needed during traction, while a lower vacuum level may be needed to maintain tissue positioning and / or maintain tissue / cannula orientation. This can be achieved, for example, by directly adjusting the vacuum level at the source or by using a user-activated valve, which can be integrated into the device itself and provides a variable or preset vacuum level. Brief description of the attached diagram

[0027] Figure 1 A perspective view showing a variant of the cannula positioning and traction platform is displayed.

[0028] Figure 2A and Figure 2B The perspective and side views of the cannula positioning and traction platform are shown, with the cannula at an angle relative to the platform.

[0029] Figures 3A-3CA side view shows an example of how the platform can be used to provide a reaction force to the cannula during insertion through tissue.

[0030] Figure 3D A side view of a platform assembly connected to a valve, which is controllable to change the suction force applied through the platform, is shown.

[0031] Figure 4A and Figure 4B A side view shows another example of how the platform can be used as a traction device to hold an area of ​​tissue in place.

[0032] Figure 5A and Figure 5B Several perspective views are shown of another variation of the cannula positioning and traction platform.

[0033] Figure 6A and Figure 6B Several perspective views are shown of yet another variant of the platform configured for organizing traction and manipulation.

[0034] Figure 7 A detailed side view of the platform is shown, illustrating an example of a fixing mechanism.

[0035] Figure 8A and Figure 8B Several perspective views are shown of yet another variant of the platform configured for organizing traction and manipulation.

[0036] Figure 9A and Figure 9B Top and side views show another variant of the platform configured for organizing traction and manipulation.

[0037] Figure 9C It shows Figure 9A and Figure 9B The side view of the platform shows how the platform can be reconfigured to maintain the shape of its contact area with the tissue.

[0038] Figure 10A and Figure 10B Several perspective views are shown of a separate suction mechanism for temporary attachment to tissue areas.

[0039] Figure 11 It shows Figure 10A and Figure 10B A cross-sectional side view of the suction mechanism.

[0040] Figure 12A and Figure 12B Several perspective views show another variation of a separate suction mechanism for temporary attachment to tissue areas.

[0041] Figure 13 It showsFigure 12A and Figure 12B A cross-sectional side view of the suction mechanism in the image.

[0042] Figure 14 A cross-sectional side view of another variant of the separate suction mechanism is shown.

[0043] Figure 15 A side view of the platform used in conjunction with the needle is shown.

[0044] Figure 16 A side view of the platform used in conjunction with imaging instruments such as a laparoscope is shown.

[0045] Figure 17 A perspective view of the platform is shown, which has an integrated ultrasound sensor to provide imaging when used with the platform.

[0046] Detailed description of the invention

[0047] When entering a region within a subject's body, cannula devices are typically used to provide access for various surgical instruments, such as laparoscopic instruments. During the initial insertion of the cannula through the skin and tissue layers, there is a risk that the cannula may unintentionally damage underlying tissue. Furthermore, once inserted into the patient's body through the skin surface, the cannula and / or instruments can be repositioned or angled relative to the underlying tissue as desired. Additionally, during surgical procedures, the subcutaneous tissue can be temporarily retracted or moved as desired to facilitate the procedure being performed on the subject.

[0048] exist Figure 1 The perspective view shows a variation of the cannula positioning platform, which can also be used for tissue traction or positioning. The positioning platform 10 is shown as a base plate 12 having a first side and a second side, on which a cannula positioning guide 26 may extend. The second side is configured to apply a releasable vacuum through one or more aspiration openings 20, which may adhere to the tissue surface for temporary fixation. A pump or negative pressure mechanism positioned away from the base plate 12 may be fluidly coupled to the base plate 12 via one or more fluid lines to provide vacuum force. The one or more aspiration openings 20 may be distributed on the base plate 12 in a uniform, arbitrary, or predetermined number configuration. Each of the one or more aspiration openings 20 may define a chamber defined by a single aspiration assembly 22. Although the number of aspiration openings 20 may vary between one and multiple openings, a variation of the base plate 12 may include, for example, twenty-one to twenty-five aspiration openings.

[0049] The substrate 12 can be formed in any different configuration (e.g., circular, elliptical, rectangular, pentagonal, hexagonal, octagonal, etc.) as long as the substrate 12 can be positioned on the target tissue region as desired. Although the substrate 12 can be formed in many different configurations, the illustrated variations may include a first flexible layer 14 and a second flexible layer 16 positioned opposite the first layer 14, such that a fixing layer 18 is formed between the first layer 14 and the second layer 16 and the first layer 14 and the second layer 16 are free to slide relative to each other. The first layer 14 and the second layer 16 may be fixed to each other around their peripheries or otherwise sealed to each other, such that the fixing layer 18 therebetween forms an airtight chamber in fluid communication with each of one or more suction openings 20. The fixing layer 18 may be completely or at least partially filled with means that restrict sliding movement between the first layer 14 and the second layer 16, such as perforations, meshes, beads, grooves, channels that are laterally or angularly positioned relative to each other, protrusions on opposing surfaces, or any material or feature that increases the frictional resistance between the first layer 14 and the second layer 16. If the mesh layer is used as the fixing layer 18, there is no minimum thickness or porosity that the mesh may have, as long as the mesh provides sufficient frictional resistance to the movement between the first layer 14 and the second layer 16 when it collapses due to vacuum force.

[0050] During the initial positioning of the substrate against the tissue region, the first layer 14 and the second layer 16 can slide freely relative to each other and relative to the fixing layer 18, thereby allowing the substrate 12 to conform to the anatomical structure of the underlying attached tissue. Once a vacuum force, such as 600 to 650 mmHg, is applied through the substrate 12 via a fluidly connected vacuum line, one or more suction openings 20 can be attached to the underlying tissue due to the negative pressure, and the first layer 14 and the second layer 16 can collapse onto or toward each other. The presence of the fixing layer 18 can increase the frictional resistance between the contact inner surfaces of the first layer 14 and the second layer 16 against each other and against the fixing layer 18, allowing the substrate 12 to maintain its reconfigured shape. If the substrate 12 is reconfigured to conform to the anatomical structure of the underlying tissue or reconfigured to another shape, applying negative pressure can cause the first layer 14 and the second layer 16 to collapse such that the substrate 12 can maintain its configuration during the application of vacuum. If the substrate 12 is attached to the underlying tissue in a flat configuration, applying negative pressure can cause the first layer 14 and the second layer 16 to collapse, thus maintaining the flat configuration. Once the vacuum force is released or the pressure is increased, the first layer 14 and the second layer 16 can be released from each other and from the fixing layer 18, allowing the substrate 12 to be released from the tissue and return to its flexible shape for removal or attachment to the tissue or another area of ​​the tissue.

[0051] The substrate 12 may also define one or more channels or openings 24 extending from the periphery of the substrate 12 toward the needle positioning guide 26 to further provide flexibility to the substrate 12. Furthermore, the needle positioning guide 26 may protrude from the substrate 12, for example, laterally or at an angle relative to the substrate 12, such that the positioning guide 26 includes a needle channel 30 defining a cavity 32 through the substrate 12 to allow a needle 36 to pass through and enter the underlying tissue. The needle 36 may be seen extending through the needle channel 30, such that the distal tip 38 of the needle is pushed through the substrate 12 and into the underlying tissue. The positioning guide 26 may also have a shoulder 28 projecting radially from a proximal portion of the needle channel 30, providing a handle for user manipulation and adjustment of the positioning guide 26 and the substrate 12, and also facilitating insertion of the needle 36 into the needle channel 30. The cannula channel 30 may also define an opening or slit 34 along the channel 30, thereby providing angled positioning of the cannula 36 relative to the substrate 12 and the cannula positioning guide 26 in a controlled manner. Therefore, the width of the opening or slit 34 along the cannula channel 30 may have a dimension that is the same as or slightly larger than the diameter of the cannula 36 itself.

[0052] Figure 2A and Figure 2B Perspective and side views are shown of a substrate 12 and a cannula 36 angled relative to the substrate 12. With the substrate 12 attached to a tissue surface, the cannula 36 can be inserted at an angle relative to the substrate 12 and / or the tissue surface, or the cannula 36 can be angled after insertion such that the body of the cannula 36 is positioned within or along an opening or slit 34 defined by a channel 30. In either case, the cannula 36 can be positioned at an angle θ such that the longitudinal axis of the cannula 36 is angled relative to the longitudinal axis of the positioning guide 26. The angle θ, depending on the desired positioning of the cannula 36, ​​can vary between, for example, 0 degrees and close to 90 degrees. Although the positioning guide 26 is illustrated as having a channel 30, other variations of the positioning guide 26 may include other pivoting mechanisms, such as a ball pivot, etc.

[0053] Figures 3A-3C A side view illustration shows an example of how the cannula positioning platform 10 can be used for tissue traction during insertion of the cannula 36 into the target tissue region. Figure 3AAs shown, platform 10 can be positioned above the target tissue area to be treated, and one or more suction openings 20 can be positioned to contact the tissue, such as the skin surface S, such that the positioning guide 26 protrudes away from the skin surface S, as shown. Vacuum force can be activated by a pump 41 fluidly connected via one or more fluid lines 43 and applied through substrate 12, causing the one or more suction openings 20 to generate an adhesion force 40 to secure substrate 12 to the skin surface S. Substrate 12 can be positioned to ensure that the openings of the positioning guide 26 are directly aligned with the tissue portion to be punctured by the cannula 36.

[0054] With the positioning platform 10 positioned in this manner, the cannula 36 can pass through the positioning guide 26 and advance toward the tissue area to be accessed by the insertion force applied to the cannula 36. Simultaneously, as... Figure 3B As shown, the reaction force 42 can be applied directly to the positioning guide 26 in the opposite direction to the insertion force 44. Because tissue adheres to one or more aspiration openings 20 and because of the reaction force 42 applied from the cannula 36 in the opposite direction to the insertion force 44, the tissue can be maintained in a relatively neutral state as the cannula 36 penetrates the skin surface S and further into the tissue. Figure 3C As shown. That is, during the initial insertion and advancement of the cannula 36 into the tissue, further indentation or collapse of the tissue into the body can be prevented. This also prevents unintentional insertion, damage, or scratching of tissue structures during cannula 36 insertion. After the cannula 36 is inserted into the tissue, the vacuum level can be selectively reduced relative to the initial level.

[0055] As the cannula 36 is inserted and passes through the tissue, its relatively large diameter may cause the tissue to "tent" inward into the patient's body as the tip of the cannula 36 is pressed through the abdomen. The amount of indentation may significantly increase the force required to place the cannula 36; however, because the practitioner not only lifts the tissue (but also helps to move any internal organs aside), the indentation is minimized, thus reducing the force required to insert the cannula 36 and decreasing the likelihood of over-insertion of the cannula 36 into the patient's body if it ruptures into the peritoneum.

[0056] When used in conjunction with the base plate 12, the pivoting positioning guide (as described herein) can be reoriented before, during, or after the insertion and / or advancement of the cannula 36 into the tissue to redirect the cannula into the tissue.

[0057] In one variation, the cannula 36 can be advanced using one of the user's hands, while the positioning guide 26 is pulled by the user's other hand. In other variations, both the insertion and advancement of the cannula 36 and the pulling of the positioning guide 26 can be performed by one of the user's hands. In yet another variation, the insertion of the cannula 36 and the pulling of the positioning guide 26 may be performed by different users.

[0058] In the example, the tissue surface S is shown to remain relatively flat during the insertion and advancement of the cannula 36. However, in other variations, the attached tissue can be pulled by the positioning platform 10 and conformed to the substrate 12 to form different configurations, such as a pulled configuration, which can then be held and locked in place by the substrate 12. In the case of a change in tissue configuration, the pulling of the positioning guide 26 can be performed in the same manner as the insertion and advancement of the cannula 36.

[0059] Although the adhesion force 40 generated by pump 41 for securing platform 10 to skin surface S can be maintained at a constant level before, during and / or after the procedure, the adhesion force can also be optionally changed. Figure 3D The illustration shows a side view of the positioning guide 26 and one or more fluid lines 43 fluidly connecting the platform 10 to the pump 41 as described above. However, this variation may include a valve 45, such as a check valve or a variable control valve, along one or more fluid lines 43 to control the magnitude of the suction force on the skin surface S. The valve 45 may be manually controlled or optionally controlled by a controller 47 in communication with the valve 45 and the pump 41. The controller 47 may be programmed, for example, to open and / or close the valve 45 at a predetermined pressure level, or the valve 45 may be programmed to open and / or close at a predetermined point in the procedure or when initiated by the user.

[0060] In another variation, a maximum first vacuum level can be applied during insertion of the cannula or other instruments, allowing the platform 10 to provide optimal lifting force to the tissue. Once insertion is complete through the tissue, the vacuum force applied by the platform 10 can be automatically reduced to a lower second vacuum level, which also prevents the formation of any bruising or hematoma that might result from the platform 10 adhering to the skin surface.

[0061] Figure 4A and Figure 4B An example is illustrated in a side view, showing a positioning platform 10 placed against and attached to tissue in a first configuration against a tissue surface. In this variation, the positioning platform 10 may have a flat configuration relative to the skin surface. As one or more suction openings 20 are attached to the tissue via adhesion 40, the positioning guide 26 and / or substrate 12 can be pulled or moved from their initial position, causing the positioning platform 10 to conform to a second configuration 50, thereby conforming the underlying attached tissue, such as...Figure 4B As shown. The substrate 12 is fitted as described herein to maintain the second configuration 50, thereby holding or maintaining the attached skin in the traction configuration. Thus, the positioning platform 10 can be used, for example, as an external tissue retractor for any number of procedures, such as for breast traction.

[0062] exist Figure 5A and Figure 5B A perspective view illustrates another variation of the positioning platform. In this variation, substrate 60 can be formed of any number of biocompatible flexible materials (e.g., polyethylene, polyvinyl chloride, silicone, etc.) configured to have an adhesive surface 62 for temporary attachment to the skin surface. Positioning guide 26 extends from the first surface, and the second surface 62 can be coated or injected with any number of biocompatible or adhesive agents (e.g., acrylate, cyanoacrylate, silicone, polyurethane, epoxy, etc.) that can temporarily attach the second surface 62 to the tissue surface. Although substrate 60 may not be attached via vacuum forces that cause the substrate layers to collapse to maintain shape or configuration, substrate 60 can still be used to traction tissue once attached and reconfigured, for example, by manually reconfiguring the tissue region. Furthermore, this variation may optionally combine a pivotable or repositionable positioning guide 26 with substrate 60.

[0063] Figure 6A and Figure 6B Another variation is shown in perspective, illustrating a substrate 70 having one or more suction openings 20 along a second side of the substrate 70 and a handle 74 fixed to a first side of the substrate 70. A vacuum tube attachment 72 is illustrated as fluidly connected along the first side of the substrate 70. This variation omits the cannula positioning guide 26 and the openings, allowing the positioning platform to function as a tissue retractor or manipulator once the substrate 70 is attached to the tissue surface. The handle 74 can be configured to allow the user to manipulate the substrate 70 to any number of various positioning configurations.

[0064] Figure 7 It shows Figure 6A and Figure 6B A modified partial cross-sectional side view illustrates how the first layer 76 and the second layer 78 can be sealed to each other, for example, around their peripheries, to form a retaining layer 80 therein. As described above, the retaining layer 80 can contain any number of materials or features designed to increase the frictional resistance between the first layer 76 and the second layer 78 when the layers collide against each other. Each of the one or more suction openings 20 can be considered to extend from the second surface and each suction opening is in fluid communication with the retaining layer 80 between the first layer 76 and the second layer 78.

[0065] Figure 8A and Figure 8B A perspective view of another variant of the substrate 90 is shown, which may be similar to the substrate 60 described herein. This variant may include a handle 74 with the substrate 90, such that once attached to a tissue surface, the positioning platform can be used as, for example, a tissue traction device or manipulator.

[0066] Figures 9A-9C Another variation is shown in top and side views, illustrating a positioning platform configured for tissue traction and / or manipulation. In this variation, the base plate 100 may include a handle 102 projecting from a first side of the base plate 100. Figure 9A As shown in the top view, the vacuum tube attachment 104 is also shown protruding from the first side and in fluid communication with the interior of the substrate. The second surface of the substrate 100 may be configured to have, for example, an adhesive (as described herein) for temporary attachment to a tissue surface. Figure 9B The side view shows a detailed cross-sectional view of the interior of substrate 100, which may be filled with particulate material, such as beads 106 (made of various materials such as plastics and polymers). The beads 106 are free to move relative to each other and are contained between the first layer 101 and the second layer 103 of substrate 100. As shown, the beads 106 are shown as being free to move internally before collapsing due to vacuum force, allowing substrate 100 to conform to anatomical structures when placed on a tissue surface. Once attached to the tissue surface in an unconstrained configuration (in which the beads 106 are free to move), substrate 100 can be reconfigured via manipulating handle 102, for example, to pull a target tissue area. While holding handle 102 in its reconfigured shape, vacuum force can be applied to the interior of substrate 100' until layers 101, 103 collapse into abutment against each other and onto the contained beads 106, such as... Figure 9C As shown. The beads 106 can collapse into each other, increasing frictional resistance and forcing the substrate 100' to maintain its reconfigured shape, and also forcing the attached tissue to maintain the same reconfigured shape, for example, remaining in a traction state. Once the vacuum force is removed and air is allowed to re-enter the interior of the substrate 100, the substrate 100 can relax its shape and allow the attached tissue to flatten or return to its initial shape.

[0067] Now turn to the structure of the single suction component 22. Figure 10A and Figure 10BA variant of several perspective views is shown. The suction assembly 22 can be formed having a suction housing 110 that protrudes to form suction chambers 112 for abutting against the surface of the tissue to be attached. The suction housing 110 can define any number of cross-sectional shapes (e.g., circular, elliptical, rectangular, polygonal, etc.) suitable for forming the suction chambers 112 and can project distally from a lower housing 114 having a lower shoulder 116 that projects radially to form the lower periphery of the lower housing 114. An upper housing 118 can be attached to the lower housing 114 and can similarly have an upper shoulder 120 that projects radially to form the upper periphery of the upper housing 118. A substrate attachment portion 122 can be formed between the lower shoulder 116 and the upper shoulder 120 for attachment to a first and second layer of a substrate. Additionally, one or more fluid channels 124 may be defined around the periphery of the substrate attachment portion 122 to provide fluid communication with the interior of the fixing layer 18. Although the lower housing 114 and the upper housing 118 are illustrated to have a circular shape relative to the annular shape of the suction housing 110, the lower housing 114 and the upper housing 118 may be formed to have other shapes or configurations.

[0068] Figure 11 The illustration shows a cross-sectional side view of a suction assembly attached to a substrate. As shown, a first layer 14 can be attached around an upper shoulder 120 to form a fluid seal, and a second layer 16 can be attached around a lower shoulder 116, also forming a fluid seal. One or more fluid channels 124 defined around the periphery of the substrate attachment portion 122 maintain fluid communication with the interior of the retaining layer 18. A housing chamber 134 can be formed between a base plate 130 of the lower housing 114 and an upper housing 118, wherein a valve 136 (such as an umbrella valve) can be biased toward the base plate 130 to maintain the valve 136 in a closed configuration abutting against the base plate 130. A retaining member 138 protruding from the valve 136 can extend through an opening 132 and partially into the suction chamber 112, the opening 132 being defined through the base plate 130. The retaining member 138 may be configured to include a widened retaining portion that allows the valve 136 to move between an open configuration and a closed configuration until the widened portion abuts against the opening 132, thereby limiting the amount by which the valve 136 can be opened.

[0069] During use, when a vacuum force is applied to the substrate, air or gas within the fixed layer 18 and the housing chamber 134 can be vented, causing the valve 136 to enter an open configuration. In this open configuration, the valve 136 extends into the interior of the housing chamber 134, while its stroke is limited by the widened retaining portion of the retaining member 138. With the valve 136 thus open, air or gas within the suction chamber 112 can also enter and pass through the housing chamber 134 via one or more openings defined by the base plate 130, and be vented through one or more fluid channels 124, causing the suction housing 110 to adhere to the underlying tissue surface due to the negative pressure generated within the suction chamber 112. When valve 136 can be optionally biased against base plate 130, once the suction pressure is balanced between housing chamber 134 and suction chamber 112 (or when the suction pressure drops below the bias closing force of valve 136), valve 136 can be pressed against base plate 130 to seal suction chamber 112 and housing chamber 134. In this way, the suction fixation between suction housing 110 and the attached tissue surface can be maintained individually between each suction assembly 22 and the tissue surface. This can be particularly useful in the event of loss of vacuum pressure within fixation layer 18 during surgery, as each individual suction assembly 22 can maintain suction attachment to the tissue surface independently of each other.

[0070] Figure 12A and Figure 12B Another variation of the suction assembly 140 is shown in several perspective views illustrating a suction housing 142 that defines a suction chamber 144 similarly formed by a lower housing having a lower shoulder 148. An upper housing 150 having an upper shoulder 152 may be attached to the lower housing 146 and form a substrate attachment portion 154 around the periphery of the housing assembly. Furthermore, one or more fluid channels 156 may be defined around the periphery of the substrate attachment portion 154.

[0071] like Figure 13As shown in the cross-sectional side view, the valve 166 is designed and positioned within the housing chamber 164 in a manner that allows for a reduced height between the lower shoulder 148 and the upper shoulder 152 relative to the aforementioned embodiments, while still allowing fluid communication with the fixing layer 18 through one or more fluid channels 156. This reduced height also allows for a relatively thin substrate. The valve 166 can be biased to remain in a closed configuration, in which the outer sealing surface 170 of the sealing member 168 is pushed against an opening 162 defined on the base plate 160 of the lower housing 146. The sealing member 168 can be configured as a cone protruding from the valve body such that when a vacuum is applied to the substrate, the valve 166 can be pushed to its open configuration, causing the sealing surface 170 to be raised away from the opening 162, achieving negative pressure within the suction chamber 144, thereby adhering the surface of the underlying tissue to the suction housing 142. As described above, when the suction pressure is balanced between the housing chamber 164 and the suction chamber 144 (or when the suction pressure drops below the bias closing force of the valve 166), the valve 166 can be pressed against the base plate 160 to seal the suction chamber 144 and the housing chamber 164. This allows a single suction assembly to adhere to the tissue surface.

[0072] As previously described, the vacuum tube accessory can be attached to the substrate to provide fluid communication between the pump and the substrate's mounting layer, as well as between the suction assembly and the pump itself. While the vacuum tube accessory can be attached anywhere on the substrate, it can also be attached to one of the suction assemblies. Figure 14 A modified cross-sectional side view is shown, in which a vacuum tube 182 having a cavity 184 defined along its length can be directly attached to at least one suction assembly. The distal end of the tube 182 can be attached to the housing of the suction assembly, such that the cavity 184 is directly fluidly connected to the housing chamber 164. The proximal end of the tube 182 can be fluidly attached to a fluid line for communication with a pump, such that when the pump is started, a vacuum force can be applied through the cavity 184 and the attached suction assembly. Because the suction assembly is fluidly connected to the fixing layer and other suction assemblies, a vacuum force can be applied accordingly to the entire substrate and the suction assembly.

[0073] Turning now to other uses or implementations of the positioning platform 10, various laparoscopic surgeries can be facilitated using any of the platform embodiments described herein. A particular surgery may involve using the platform to create a pneumoperitoneum cavity within the patient by inflating air, preparing for abdominal (or other cavity) surgery. The practitioner typically identifies a location along the patient's body, such as the abdomen, where instruments (e.g., pneumoperitoneum needles) can penetrate the skin until the tip just reaches the peritoneum. Pneumoperitoneum needles are often inserted blindly into the patient, which can lead to accidental injury. For example, if a portion of the intestine is attached to the inner wall of the peritoneum, the needle may insert into the attachment site, causing the intestine to be punctured or torn.

[0074] Once the needle is properly positioned within the patient, the cavity expands through the needle, and the master cannula may also be blindly inserted into the peritoneum. In patients with attachment, the cannula may experience complications similar to those caused by needle insertion. Then, for example, another instrument (such as a laparoscopic camera) can be inserted into the peritoneum through the master cannula to facilitate the insertion of an additional cannula under direct visualization, thus reducing the risk of internal injury.

[0075] When the positioning platform 10 is attached to the skin surface S, the platform 10 can be used to elevate the tissue area of ​​the tissue into which the needle and / or cannula will be inserted, to facilitate the separation of any intestinal tissue from the abdominal wall interior. Elevating the tissue area before inserting the needle and / or cannula can also help the operator assess the presence of any attachments.

[0076] Figure 15 An example is shown in a side view illustrating the application of platform 10 against skin surface S, which can be lifted away from the patient to elevate the attached tissue and provide feedback on the presence of any attachments. Once the assessment has been performed, needle 190 can be inserted via positioning guide 26 until the needle's piercing tip 192 or blunt tip 194 has passed over the internal tissue wall away from the attachment. Alternatively, once the assessment of platform 10 is complete, platform 10 can be removed from the tissue area and needle 190 can be inserted directly through and into skin surface S.

[0077] In other variations, platform 10 can be used directly with imaging instruments (such as laparoscope 200), such as... Figure 16 As shown in the side view. After the cannula is inserted through the skin surface S, it can be removed, leaving the cannula sleeve 202 in place across the tissue area. The laparoscope 200 can be inserted, for example, directly through the cannula sleeve 202 to provide direct visualization within the body cavity.

[0078] In another variation, platform 10 can be used in conjunction with an imaging device (such as ultrasound sensor 212), which can communicate with controller 47 (as previously described) or with a separate ultrasound controller 214, such as... Figure 17The image is shown in a perspective view. The ultrasound sensor 212 can be used, for example, to determine the presence of any attachments in the subsurface layer of the skin before applying the platform 10 against the skin surface. The ultrasound sensor 212 can be initially applied to the skin and then removed to allow the use of the platform 10, but in other variations, the ultrasound sensor 212 can be directly integrated with the platform 10. One variation is shown where one or more openings 210 can be formed through the platform 10 adjacent to the positioning guide 26, wherein an ultrasound sensor 212 can be integrated into the platform 10 at one of the openings 210. The sensor 212 can be used to provide real-time imaging of the tissue area directly beneath the platform 10 before and during cannula insertion when the platform 10 is directly attached to the skin surface S.

[0079] When the cannula is removed, the pneumoperitoneum gas can be expelled through the opening, or it can leak through the opening. To maintain a fluid seal through the opening in the tissue or through the cannula to maintain pneumoperitoneum, a seal or plug can be inserted to cover the cannula opening or directly cover the tissue opening. At the end of the procedure, the opening through the abdominal wall (e.g., larger than 12 mm) can be sutured closed.

[0080] The application of the invention discussed above is not limited to specific treatments or areas of the body, but may include any number of other treatments and areas of the body. Modifications to the methods and apparatus described above for carrying out the invention, as well as variations to various aspects of the invention, which will be apparent to those skilled in the art, are intended to be within the scope of this disclosure. Furthermore, various combinations of aspects between the various examples are contemplated and are also considered to be within the scope of this disclosure.

[0081] This invention also provides the following items:

[0082] 1. A device for positioning an instrument, comprising:

[0083] A substrate having a first surface and a second surface opposite to the first surface;

[0084] An instrument positioning guide protrudes from the first surface of the substrate;

[0085] The second surface of the substrate is configured to releasably attach to the tissue surface, and

[0086] The interior of the substrate is fluidly connected through an opening defined in the substrate.

[0087] 2. The apparatus according to item 1, wherein the substrate is configured to maintain a predetermined configuration when a vacuum force is applied inside the substrate through the opening.

[0088] 3. The apparatus according to item 2, wherein the interior of the substrate includes a fixing layer between the first surface and the second surface.

[0089] 4. The apparatus according to item 3, wherein the fixing layer is configured to increase the frictional resistance between the interior of the first surface and the interior of the second surface when the vacuum force is applied to maintain the predetermined configuration.

[0090] 5. The apparatus according to item 4, wherein the fixing layer includes a porous material, a mesh, beads, a groove, a channel, or a protrusion.

[0091] 6. The apparatus according to item 1, wherein the substrate comprises a flexible substrate capable of being reconfigured to conform to a tissue surface.

[0092] 7. The apparatus according to item 1, wherein the instrument positioning guide includes a cannula positioning guide that defines a receiving channel extending through the substrate.

[0093] 8. The device according to item 7 further includes a cannula needle having a piercing tip.

[0094] 9. The apparatus according to item 1, wherein the instrument positioning guide is pivotable relative to the base plate.

[0095] 10. The apparatus according to item 1, wherein the second surface includes an adhesive that can be releasably attached to the tissue surface.

[0096] 11. The apparatus according to item 1 further includes one or more suction components positioned along the second surface.

[0097] 12. The apparatus according to item 11, wherein each of the one or more suction components includes a valve that is biased to maintain a closed configuration.

[0098] 13. The device according to item 1 further includes a handle extending from the first surface.

[0099] 14. The apparatus according to item 1 further includes an ultrasonic sensor integrated with the substrate and positioned near the instrument positioning guide to detect features within a tissue region.

[0100] 15. A method for positioning an instrument, comprising:

[0101] The second surface of the substrate is positioned near the tissue surface, wherein the second surface is opposite to the first surface of the substrate;

[0102] The second surface is attached to the tissue surface, wherein the interior of the substrate is in fluid communication through an opening defined in the substrate;

[0103] The instrument is advanced into the tissue surface by means of an instrument positioning guide protruding from or along the first surface of the substrate; and

[0104] While advancing the instrument into the tissue surface, a reaction force is applied to the substrate.

[0105] 16. The method according to item 15, wherein attaching the second surface further includes applying a vacuum force through the opening to cause the first surface and the second surface to collapse against a fixed layer positioned between the first surface and the second surface, thereby inhibiting the movement of the first surface against the second surface.

[0106] 17. The method of claim 15, wherein attaching the second surface comprises attaching the second surface to the tissue surface via one or more suction components in internal fluid communication with the substrate.

[0107] 18. The method according to item 15, wherein attaching the second surface includes attaching the second surface to the tissue surface via an adhesive.

[0108] 19. The method according to item 15, wherein advancing the instrument includes advancing the cannula through or along the instrument positioning guide.

[0109] 20. The method according to item 19 further includes adjusting the angle of the cannula needle relative to the substrate.

[0110] 21. The method of claim 15, wherein applying the reaction force includes applying the reaction force to the instrument positioning guide while advancing the instrument into the tissue surface.

[0111] 22. The method according to item 15 further includes traction of the tissue surface via the substrate.

[0112] 23. The method of claim 15 further includes detecting features within a tissue region via an ultrasonic sensor integrated along the substrate prior to advancing the instrument.

[0113] 24. A method for positioning an instrument, comprising:

[0114] The second surface of the substrate is positioned near the tissue surface, wherein the second surface is opposite to the first surface of the substrate;

[0115] Attach the second surface to the tissue surface;

[0116] The shape of the substrate is reconfigured while the tissue surface is attached, thereby reconfiguring the tissue surface accordingly by applying a vacuum force through an opening defined in the substrate, wherein the opening is in fluid communication with the interior of the substrate;

[0117] The instrument is advanced into the tissue surface by means of an instrument positioning guide protruding from or along the first surface of the substrate; and

[0118] While advancing the instrument into the tissue surface, a reaction force is applied to the substrate.

[0119] 25. The method according to item 24, wherein attaching the second surface further includes causing the first surface and the second surface to abut against a collapsing fixing layer positioned between the first surface and the second surface, such that when the vacuum force is applied through the opening, movement of the first surface against the second surface is suppressed.

[0120] 26. The method of claim 24, wherein attaching the second surface comprises attaching the second surface to the tissue surface via one or more suction components in internal fluid communication with the substrate.

[0121] 27. The method according to item 24, wherein attaching the second surface includes attaching the second surface to the tissue surface via an adhesive.

[0122] 28. The method according to item 24, wherein advancing the instrument includes advancing the cannula through or along the instrument positioning guide.

[0123] 29. The method according to item 28 further includes adjusting the angle of the cannula needle relative to the substrate.

[0124] 30. The method of claim 24, wherein applying the reaction force includes applying the reaction force to the instrument positioning guide while advancing the instrument into the tissue surface.

[0125] 31. The method according to item 24 further includes traction of the tissue surface via the substrate.

[0126] 32. The method according to item 24 further includes detecting features within a tissue region via an ultrasonic sensor integrated along the substrate prior to advancing the instrument.

[0127] 33. A device for traction of a tissue region, comprising:

[0128] A substrate having a first surface and a second surface opposite to the first surface;

[0129] The second surface is configured to releasably attach to a tissue surface, and the interior of the substrate is fluidly connected through an opening defined in the substrate.

[0130] The substrate is configured to maintain a predetermined configuration when a vacuum force is applied.

[0131] 34. The apparatus according to item 33, wherein the substrate includes a fixing layer located between the first surface and the second surface.

[0132] 35. The apparatus according to item 34, wherein the fixing layer is configured to increase the frictional resistance between the interior of the first surface and the interior of the second surface when the vacuum force is applied to maintain the predetermined configuration.

[0133] 36. The apparatus according to item 35, wherein the fixing layer includes a porous material, a mesh, beads, a groove, a channel, or a protrusion.

[0134] 37. The apparatus according to item 33, wherein the substrate includes a flexible substrate capable of being reconfigured to conform to a tissue surface.

[0135] 38. The apparatus according to item 33, wherein the second surface includes an adhesive that can be releasably attached to the tissue surface.

[0136] 39. The apparatus of claim 33 further includes one or more suction components positioned along the second surface and in fluid communication with the interior of the substrate.

[0137] 40. The apparatus according to item 39, wherein each of the one or more suction components includes a valve that is biased to maintain a closed configuration.

[0138] 41. The device according to item 33 further includes a handle extending from the first surface.

[0139] 42. The apparatus according to item 33 further includes an ultrasonic sensor integrated with the substrate, and the ultrasonic sensor is positioned to detect features within a tissue region.

[0140] 43. A method for traction of a tissue region, comprising:

[0141] The second surface of the substrate is positioned near the tissue surface, wherein the second surface is opposite to the first surface of the substrate;

[0142] The second surface is attached to the tissue surface, wherein the interior of the substrate is in fluid communication through an opening defined in the substrate; and

[0143] The first configuration of the substrate is maintained by a vacuum force applied through the opening, such that the surface of the attached tissue conforms to the first configuration.

[0144] 44. The method according to item 43 further includes adjusting the substrate to a second configuration while attaching the tissue surface, such that the tissue surface conforms to the second configuration.

[0145] 45. The method according to item 43, wherein attaching the second surface further includes causing the first surface and the second surface to abut against a collapsing fixing layer positioned between the first surface and the second surface, thereby inhibiting movement of the first surface against the second surface.

[0146] 46. ​​The method of claim 43, wherein attaching the second surface comprises attaching the second surface to the tissue surface via one or more suction components in internal fluid communication with the substrate.

[0147] 47. The method according to item 46 further includes attaching the one or more suction components to the tissue surface while reducing or removing the vacuum force.

[0148] 48. The method according to item 43, wherein attaching the second surface includes attaching the second surface to the tissue surface via an adhesive.

Claims

1. A device for positioning instruments, comprising: A substrate having a first layer and a second layer opposite to the first layer; An instrument positioning guide protrudes from the first layer of the substrate; The second layer of the substrate is configured to releasably attach to the tissue surface, and The interior of the substrate is defined between the first layer and the second layer, and the interior of the substrate is in fluid communication through an opening defined in the substrate. The substrate includes a fixing layer located between the first layer and the second layer.

2. The apparatus according to claim 1, wherein, The substrate is configured to maintain a predetermined configuration when a vacuum force is applied inside the substrate through the opening.

3. The apparatus according to claim 2, wherein, The fixing layer is configured to increase the frictional resistance between the interior of the first layer and the interior of the second layer when the vacuum force is applied to maintain the predetermined configuration.

4. The apparatus according to claim 3, wherein, The fixing layer includes porous materials, meshes, beads, grooves, channels, or protrusions.

5. The apparatus according to claim 1, wherein, The substrate includes a flexible substrate that can be reconfigured to conform to the tissue surface.

6. The apparatus according to claim 1, wherein, The instrument positioning guide defines a receiving channel that extends through the substrate.

7. The device according to claim 6 further includes a needle having a piercing tip.

8. The apparatus according to claim 1, wherein, The instrument positioning guide is pivotable relative to the substrate.

9. The apparatus according to claim 1, wherein, The second layer includes an adhesive that can be releasably attached to the surface of the tissue.

10. The apparatus of claim 1, further comprising one or more suction components positioned along the second layer.

11. The apparatus according to claim 10, wherein, Each of the one or more suction components includes a valve that is biased to maintain a closed configuration.

12. The device of claim 1, further comprising a handle extending from the first layer.

13. The apparatus of claim 1 further includes an ultrasonic sensor integrated with the substrate and positioned near the instrument positioning guide to detect features within a tissue region.

14. A device for traction of a tissue region, comprising: A substrate having a first layer and a second layer opposite to the first layer; The second layer is configured to releasably attach to a tissue surface, and an interior of the substrate is defined between the first and second layers, the interior of the substrate being in fluid communication through an opening defined in the substrate. The substrate is configured to maintain a predetermined configuration when a vacuum force is applied. The substrate includes a fixing layer located between the first layer and the second layer.

15. The apparatus according to claim 14, wherein, The fixing layer is configured to increase the frictional resistance between the interior of the first layer and the interior of the second layer when the vacuum force is applied to maintain the predetermined configuration.

16. The apparatus according to claim 15, wherein, The fixing layer includes porous materials, meshes, beads, grooves, channels, or protrusions.

17. The apparatus according to claim 14, wherein, The substrate includes a flexible substrate that can be reconfigured to conform to the tissue surface.

18. The apparatus according to claim 14, wherein, The second layer includes an adhesive that can be releasably attached to the surface of the tissue.

19. The apparatus of claim 14, further comprising one or more suction components positioned along the second layer and in fluid communication with the interior of the substrate.

20. The apparatus according to claim 19, wherein, Each of the one or more suction components includes a valve that is biased to maintain a closed configuration.

21. The device of claim 14, further comprising a handle extending from the first layer.

22. The apparatus of claim 14, further comprising an ultrasonic sensor integrated with the substrate, wherein the ultrasonic sensor is positioned to detect features within a tissue region.

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