Retractor device

Abstract

To provide a pneumoperitoneum / trocar device that can be safely inserted into a patient body and can reduce a risk of damaging a lower tissue, the device enabling positioning and retraction of a tissue site during treatment without being accompanied by a risk of damage or inadvertent movement.SOLUTION: A trocar device for positioning an instrument generally includes a substrate 12 having a first surface 14 and a second surface 16 opposite to the first surface, an instrument positioning guide 26 projecting from the first surface of the substrate, and one or more suction assemblies 22 disposed along the second surface and in fluid communication with an interior of the substrate. The one or more suction assemblies may be attachable to a tissue region via vacuum force applied through the one or more suction assemblies. The device may also have the substrate configured to maintain a predetermined configuration when the vacuum force is applied.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention generally relates to medical devices and methods. More particularly, the present invention relates to trocar devices and devices and methods for positioning tissue sites.

Background Art

[0002] Trocars are generally used to access the lumens within the body through the skin surface during surgical procedures such as laparoscopic surgery. Generally, a trocar includes a blunt or sharp obturator that is inserted through a hollow cannula. By inserting the trocar through the skin surface into a body cavity such as the abdomen, the obturator can be removed from the cannula, leaving an access path into the body cavity through the cannula. Unfortunately, trocars typically do not provide any indication of the trocar penetration depth to the user, who must estimate the penetration depth during and after abdominal wall penetration.

[0003] Furthermore, when a trocar is inserted, it can cause traumatic injury by puncture to the underlying organs or structural tissues, which can lead to complications. For example, laparoscopic trocar insertion can potentially damage the underlying intestine or cause bleeding in various blood vessels. Furthermore, this problem is further complicated because when inserting a trocar into tissue, the tissue tends to collapse or become concave around the trocar.

[0004] To reduce the occurrence of unintentional perforations, a surgeon can establish pneumoperitoneum by insufflating the abdomen with gas that expands the space between the interior of the abdominal wall and the underlying viscera for the purpose of providing a space for the trocar to penetrate the abdominal wall and reach above the organs. Pneumoperitoneum is typically performed using a Veress needle that is inserted through the abdominal cavity to supply gas, but this needle also potentially causes complications similar to trocar insertion.

[0005] Once the obturator is removed after penetrating the body wall, a cannula that has penetrated the body remains, and any number of surgical instruments can be received. However, the guide tube may move unexpectedly or undesirably, such as changes in the penetration depth or accidental withdrawal from the body.

Summary of the Invention

Problems to be Solved by the Invention

[0006] Therefore, there is a need for a pneumoperitoneum / trocar device that can be safely inserted into a patient's body and can reduce the risk of damage to the underlying tissue. There is also a need for a device that enables positioning and access to tissue sites during a procedure without the risk of damage or inadvertent movement.

Means for Solving the Problems

[0007] A trocar positioning platform according to one aspect can also be used for tissue access and positioning. The positioning platform may include a substrate having a first surface through which a trocar positioning guide extends and a second surface configured to apply a releasable vacuum through one or more suction ports that can adhere to the tissue surface for temporary fixation. A pump or negative pressure mechanism disposed remotely from the substrate is fluidly coupled to the substrate via one or more fluid lines and can provide a vacuum force. The one or more suction ports may be distributed uniformly on the substrate, in any manner, or in any number of predetermined specific configurations. Each of the one or more suction ports may form a chamber formed by an individual suction assembly. The number of suction ports may vary from one to a plurality of openings, but a substrate according to one aspect may incorporate, for example, 21 to 25 suction ports.

[0008] The substrate can be formed into various shapes such as circular, elliptical, rectangular, pentagonal, hexagonal, octagonal, etc., as long as it can be preferably placed on the target tissue site. The substrate can be formed in various forms. In the illustrated embodiment, it may be composed of a layer with a first flexibility and a layer with a second flexibility located on the opposite side of the first layer. A fixing layer may be formed between them, and the first layer and the second layer may be configured to be slidable relative to each other. The first layer and the second layer may be fixed or sealed in other ways relative to each other at their outer peripheral portions such that the fixing layer therebetween is formed in an airtight chamber that is in fluid communication with each of one or more suction ports. The fixing layer may be completely or at least partially filled with a material that limits the sliding between the first layer and the second layer, such as a screen, mesh, beads, grooves, channels that are lateral or angled relative to each other, protrusions on the opposing surfaces, or any substance or element that increases the frictional resistance between the first layer and the second layer. When using a mesh layer as the fixing layer, there is no minimum value for its thickness or porosity as long as the mesh provides sufficient frictional resistance to the movement between the first layer and the second layer when crushed by the vacuum force.

[0009] When initially positioning the substrate with respect to the tissue site, the first layer and the second layer can slide freely relative to each other and relative to the fixing layer, whereby the substrate can conform to the tissue structure of the underlying adherent tissue. Once a vacuum force, for example, in the range of 600 to 650 mmHg (about 80 kPa to 86.6 kPa), is applied through the fluid-connected vacuum line across the substrate, one or more suction ports adhere to the underlying tissue by negative pressure, and the first layer and the second layer may collapse on top of each other or towards each other. By providing the fixing layer, the frictional resistance between the contacting inner surfaces of the first layer and the second layer and the frictional resistance against the fixing layer may be increased such that the substrate freezes in the reconfigured shape. When reconfiguring the substrate to conform to the structure of the underlying tissue or to another shape, when applying negative pressure, the first layer and the second layer collapse, whereby the substrate may maintain its form while the vacuum is applied. When the substrate is adhered to the underlying tissue in a flat form, by applying negative pressure, the first layer and the second layer may be collapsed so that the flat form is maintained. Once the vacuum force is released or the pressure is increased, the first layer and the second layer are released from each other and from the fixing layer, whereby the substrate is released from the tissue and can return to a shape that provides flexibility for removal from or attachment to the tissue or another site of the tissue.

[0010] The substrate can further form one or more channels or openings extending from the outer peripheral portion of the substrate towards the pneumoperitoneum / trocar positioning guide, further providing flexibility of the substrate. Further, the trocar positioning guide projects from the substrate, for example, laterally or at an angle with respect to the substrate, and the positioning guide constitutes a trocar channel that forms a lumen passing through the substrate so that the trocar can pass through and enter the tissue thereunder. The positioning guide may also have a shoulder projecting radially from the proximal portion of the trocar channel, which provides a handle for facilitating the operation and adjustment of the positioning guide and the substrate by the user and also facilitates the insertion of the trocar into the trocar channel. The trocar channel may further be provided with openings or slits along the channel to position the trocar at an angle in a controlled manner with respect to the substrate and the trocar positioning guide. Thus, the width of the opening or slit along the trocar channel may have a dimension equal to or slightly larger than the diameter of the trocar itself. Further, a plurality of replaceable guides for specific applications or procedures for improving access or incision, such as incision for tissue positioning, pneumoperitoneum, trocar placement, or closure of the fascia, may be provided.

[0011] In one example of use, the platform is positioned over the relevant tissue site to be treated, and one or more suction ports may be placed in contact with the tissue, for example, on the skin surface, such that the positioning guide projects away from the skin surface. The vacuum force is activated via a pump fluidly coupled via one or more fluid lines and may be applied via the substrate such that the one or more suction ports create an adhesive force for securing the substrate on the skin surface. The substrate may be positioned such that the opening of the positioning guide is reliably aligned directly above the site of the tissue to be punctured by the trocar.

[0012] With the positioning platform positioned in this way, while applying an insertion force to the trocar, the trocar can be advanced toward the tissue site to be entered through the positioning guide. At the same time, a reaction force in the direction opposite to the insertion force may be directly applied to the positioning guide. When the trocar is inserted further into the tissue through the skin surface with the tissue adhered to one or more suction ports and a reaction force applied in the direction opposite to the insertion force from the trocar, the tissue may be maintained in a relatively neutral state. That is, when the trocar is first inserted and advanced into the tissue, it is possible to prevent the tissue from being indented or further collapsing into the body. Thereby, inadvertent insertion, damage, and laceration of the tissue structure during trocar insertion can be further prevented. After the trocar is inserted into the tissue, the vacuum level may be arbitrarily reduced from the initial level.

[0013] The positioning platform according to another example may utilize a substrate formed from any number of biocompatible and flexible materials (e.g., polyethylene, polyvinyl, silicone, etc.) configured to have an adhesive surface for temporary fixation to the skin surface. With the positioning guide extending from the first surface, the second surface may be coated or injected with any number of biocompatible agents or adhesives (e.g., acrylate, cyanoacrylate, silicone, polyurethane, epoxy, etc.) capable of temporarily adhering the second surface to the tissue surface. The substrate may not be adhered via a vacuum force that collapses the layers of the substrate to maintain its shape or form, but the substrate may be used not only to reconfigure the tissue, for example, by manually reconfiguring the tissue area, but also to open the tissue once adhered. Further, in this aspect, a pivotal or steerable positioning guide integral with the substrate can be optionally incorporated.

[0014] As yet another alternative example, it is also possible to utilize a handle fixed to the first surface of the substrate. In this embodiment, the trocar positioning guide and the opening are omitted, and thereby, once the substrate is adhered to the tissue surface, the positioning platform is used as a tissue opener or a manipulator. The handle can be configured in any number of forms so that the user can manipulate the substrate to various positions.

[0015] As yet another alternative example, the substrate may incorporate a handle protruding from the first surface of the substrate. The second surface of the substrate may be configured to have, for example, an adhesive (described herein) for temporary attachment to the tissue surface. The interior of the substrate may be filled with particulate materials such as beads (formed from any of a variety of materials such as plastics, polymers, etc.) that can move freely relative to each other and are contained between the first and second layers of the substrate. The beads can move freely before the interior is crushed by the force of a vacuum, such that the substrate can conform to the anatomical tissue structure when placed on the tissue surface. Once the beads are adhered to the tissue surface in a state where they can move freely without constraints, the handle can be operated to reconfigure the substrate, for example, to open the target tissue site. Also, a vacuum force may be applied to the interior of the substrate while keeping the handle portion in the reconfigured shape until the layers collapse relative to each other and to the contained beads. The beads may collapse relative to each other, for example, to increase frictional resistance, to force the substrate to maintain the reconfigured shape, and to force the adhered tissue to maintain the same reconfigured shape, such as to maintain a forcibly opened state. Once the vacuum force is removed and air re-enters the interior of the substrate, the shape of the substrate may relax, and the adhered tissue may flatten or return to its original shape.

[0016] An apparatus for positioning an instrument according to one aspect generally includes a substrate having a first surface and a second surface opposite the first surface, an instrument positioning guide protruding 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. The one or more suction assemblies may be attachable to a tissue site via a vacuum force applied through the one or more suction assemblies. The apparatus may have a substrate configured to maintain a predetermined shape when a vacuum force is applied.

[0017] A method for positioning an instrument according to one aspect generally includes positioning the second surface of a substrate adjacent to a tissue surface, opposite the first surface of the substrate, adhering one or more suction assemblies to the tissue surface via a vacuum force applied through the one or more suction assemblies that are in fluid communication with the interior of the substrate and positioned along the second surface, advancing the instrument through or along an instrument positioning guide protruding from the first surface of the substrate to the tissue surface, and applying a reaction force to the substrate while advancing the instrument to the tissue surface.

[0018] A method for positioning an instrument according to one aspect generally includes positioning the second surface of a substrate adjacent to a tissue surface, opposite the first surface of the substrate, adhering one or more suction assemblies to the tissue surface via a vacuum force applied through the one or more suction assemblies that are in fluid communication with the interior of the substrate and positioned along the second surface, reconfiguring the shape of the substrate while adhering the tissue surface to the one or more suction assemblies such that the tissue surface is reconfigured accordingly, advancing the instrument through or along an instrument positioning guide protruding from the first surface of the substrate to the tissue surface, and applying a reaction force to the substrate while advancing the instrument to the tissue surface.

[0019] Yet another device for creating a tissue pocket may generally include a substrate having a first surface and a second surface opposite the first surface, and one or more suction assemblies positioned along the second surface and in fluid communication with the interior of the substrate, where the one or more suction assemblies are attachable to the tissue site via a vacuum force applied through the one or more suction assemblies, and the substrate is configured to maintain a predetermined shape when the vacuum force is applied.

[0020] Yet another method of positioning the instrument may generally include positioning the second surface of the substrate adjacent to the tissue surface, opposite the first surface of the substrate, and adhering one or more suction assemblies to the tissue surface via a vacuum force applied through one or more suction assemblies positioned along the second surface and in fluid communication with the interior of the substrate, and maintaining a first shape of the substrate via the vacuum force such that the adhered tissue surface conforms to the first shape of the substrate.

[0021] In all embodiments, the amount of vacuum required is expected to vary by procedure. For example, a higher vacuum level is required during creation, while a lower vacuum level is required for maintaining the position on the tissue and / or maintaining the orientation of the tissue / trocar. This is achieved, for example, by directly adjusting the vacuum level at the vacuum source or by a user-activated valve integrated into the device itself that can vary or preset the vacuum level.

Brief Description of the Drawings

[0022]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0023] When accessing a site within a patient's body, a trocar device is typically used to provide access to the body for various surgical instruments such as laparoscope instruments. When inserting a trocar through the skin and tissue layers, there is a risk that the trocar may inadvertently damage the underlying tissue. Further, once inserted into the patient's body through the skin surface, the trocar and / or instrument may be repositioned or angled as desired with respect to the underlying tissue. Additionally, during a surgical procedure, the tissue beneath the skin may be incised or temporarily displaced as desired to facilitate access to the subject.

[0024] FIG. 1 shows a trocar positioning platform according to one aspect that can also be used for tissue creation or positioning. The positioning platform 10 is shown as a substrate 12 having a first surface on which a trocar positioning guide 26 extends and a second surface configured to be releasably evacuated through one or more suction ports 20 that may be adhesively attached to the tissue surface for temporary fixation. A pump or negative pressure mechanism located remotely from the substrate 12 can be fluidly coupled to the substrate 12 via one or more fluid lines to provide a vacuum force. The one or more suction ports 20 can be distributed uniformly, arbitrarily, or in any number of predetermined specific patterns on the substrate 12. Each of the one or more suction ports 20 may be provided with a chamber formed by an individual suction assembly 22. The number of suction ports 20 can vary from one to multiple, but the substrate 12 according to one aspect can incorporate, for example, 21 to 25 suction ports.

[0025] The substrate 12 can be formed in various shapes, such as circular, elliptical, rectangular, pentagonal, hexagonal, octagonal, etc., as long as it can be preferably disposed on the target tissue site. Although the substrate 12 can be formed in various forms, in the illustrated embodiment, it may be composed of a first flexible layer 14 and a second flexible layer 16 located on the opposite side of the first layer 14, and a fixing layer 18 may be formed therebetween, and the first layer 14 and the second layer 16 may be configured to be slidable relative to each other. The first layer 14 and the second layer 16 may be fixed or sealed in other ways relative to each other at their outer peripheral portions such that the fixing layer 18 therebetween is formed in an airtight chamber that is in fluid communication with each of one or more suction ports 20. The fixing layer 18 is a material that restricts the sliding between the first layer 14 and the second layer 16, such as a screen, mesh, beads, grooves, channels that are transverse or angled relative to each other, protrusions on the opposing surfaces, or may be completely or at least partially filled with any substance or element that increases the frictional resistance between the first layer 14 and the second layer 16. When using a mesh layer as the fixing layer 18, there is no minimum value for its thickness or porosity as long as the mesh provides sufficient frictional resistance to the movement between the first layer 14 and the second layer 16 when crushed by the force of a vacuum.

[0026] When initially positioning the substrate with respect to the tissue site, the first layer 14 and the second layer 16 can slide freely relative to each other and relative to the fixing layer 18, whereby the substrate 12 can conform to the tissue structure of the underlying adherent tissue. Once a vacuum force of, for example, 600 to 650 mmHg (about 80 kPa to 86.6 kPa) is applied through the fluid-coupled vacuum line across the substrate 12, one or more suction ports 20 adhere to the underlying tissue by negative pressure, and the first layer 14 and the second layer 16 may collapse on top of each other or towards each other. By providing the fixing layer 18, the frictional resistance between the contacting inner surfaces of the first layer 14 and the second layer 16 relative to each other and the frictional resistance relative to the fixing layer 18 may be increased such that the substrate 12 freezes in the reconfigured shape. When reconfiguring the substrate 12 to conform to the structure of the underlying tissue or to another shape, upon applying negative pressure, the first layer 14 and the second layer 16 collapse, whereby the substrate 12 may maintain its form while the vacuum is applied. When the substrate 12 is adhered to the underlying tissue in a flat form, the first layer 14 and the second layer 16 may be collapsed by applying negative pressure such that the flat form is maintained. Once the vacuum force is released or the pressure is increased, the first layer 14 and the second layer 16 are released from each other and from the fixing layer 18, whereby the substrate 12 is released from the tissue and can return to a shape that is flexible for removal from or attachment to the tissue or another site of the tissue.

[0027] The substrate 12 further forms one or more channels or openings 24 extending from the outer peripheral portion of the substrate 12 towards the trocar positioning guide 26, and can further provide flexibility to the substrate 12. Further, the trocar positioning guide 26 projects from the substrate 12, for example, laterally or at an angle with respect to the substrate 12, and the positioning guide 26 constitutes a trocar channel 30 that forms a lumen 32 passing through the substrate 12 so that the trocar 36 can pass through and enter the underlying tissue. The trocar 36 may be shown to extend through the trocar channel 30 such that the trocar distal tip 38 is pushed into the underlying tissue beyond the substrate 12. The positioning guide 26 may also have a shoulder 28 projecting radially from the proximal portion of the trocar channel 30, which provides a handle for facilitating the operation and adjustment of the positioning guide 26 and the substrate 12 by the user, and also facilitates the insertion of the trocar 36 into the trocar channel 30. The trocar channel 30 may further be provided with an opening or slit 34 along the channel 30 to position the trocar 36 at an angle in a controlled manner with respect to the substrate 12 and the trocar positioning guide 26. Thus, the width of the opening or slit 34 along the trocar channel 30 may have a dimension that is the same as or slightly larger than the diameter of the trocar 36 itself.

[0028] Figures 2A and 2B are a perspective view and a side view showing the substrate 12 and the trocar 36 angled with respect to the substrate 12. With the substrate 12 adhered to the tissue surface, the trocar 36 can be inserted at an angle with respect to at least one of the substrate 12 and the tissue surface. After insertion, the trocar 36 may be angled such that the body of the trocar 36 enters or is positioned along an opening or slit 34 provided along the channel 30. In either case, the trocar 36 may be positioned such that the longitudinal axis of the trocar 36 is angled at an angle θ with respect to the longitudinal axis of the positioning guide 26. The angle θ can be in any range, for example, from 0 degrees to nearly 90 degrees, depending on the desired position of the trocar 36. The positioning guide 26 is illustrated as having a channel 30, but other variations of the positioning guide 26 may include other pivoting mechanisms such as a ball pivot.

[0029] An example is shown in the side views of FIGS. 3A - 3C, which show a method by which a trocar positioning platform 10 can be used to create an opening in tissue during insertion of the trocar 36 into a relevant tissue site of interest. As shown in FIG. 3A, the platform 10 is positioned over the relevant tissue site to be treated, and one or more suction ports 20 may be placed in contact with the tissue, e.g., on the skin surface S, such that the positioning guide 26 protrudes away from the skin surface S. The vacuum force may be activated via a pump 41 fluidly coupled via one or more fluid lines 43, and through the substrate 12, one or more suction ports 20 may generate an adhesive force 40 and be applied to fix the substrate 12 to the skin surface S. The substrate 12 may be positioned such that the opening of the positioning guide 26 is directly and surely positioned over the portion of the tissue to be punctured by the trocar 36.

[0030] With the positioning platform 10 positioned as such, while applying an insertion force 44 to the trocar 36, the trocar 36 can be advanced toward the tissue site to be accessed through the positioning guide 26. At the same time, as shown in FIG. 3B, a reaction force 42 may be directly applied to the positioning guide 26 in the direction opposite to the insertion force 44. As shown in FIG. 3C, when the tissue is adhered to one or more suction ports 20 and a reaction force 42 is applied in the direction opposite to the insertion force 44 from the trocar 36, and the trocar 36 is inserted further into the tissue through the skin surface S, the tissue may be maintained in a relatively neutral state. That is, when the trocar 36 is first inserted and advanced into the tissue, it is possible to prevent the tissue from being indented or further collapsing into the body. Thereby, it is possible to further prevent inadvertent insertion, damage, and laceration of the tissue structure during insertion of the trocar 36. After the trocar 36 is inserted into the tissue, the vacuum level may be arbitrarily reduced from the initial level.

[0031] When the trocar 36 is inserted into the tissue and passes through the tissue, when the tip of the trocar 36 is pressed through the abdomen, the relatively large diameter of the trocar 36 can "tent" the tissue toward the inside of the patient. The force required for insertion of the trocar 36 increases considerably depending on the amount of tenting, but since the operator can not only lift the tissue (and further assist in moving the internal organs so as not to interfere) but also minimize the tenting of the tissue, the force required to insert the trocar 36 is reduced, and the possibility that the trocar 36 pierces the peritoneum and is overly inserted into the patient's body is also reduced.

[0032] When using a pivotal positioning guide (described herein) together with the substrate 12, the orientation of the positioning guide can be changed to change the direction of trocar insertion into the tissue before, during, or after insertion and / or advancement of the trocar 36 into the tissue.

[0033] In one aspect, the trocar 36 can be advanced using one hand of the user, and the positioning guide 26 can be deployed using the other hand of the user. In another variant, in addition to the insertion and advancement of the trocar 36, the deployment of the positioning guide 26 may be performed with one hand of the user. In yet another variant, both the insertion of the trocar 36 and the deployment of the positioning guide 26 may be performed by another user.

[0034] The tissue surface S is illustrated as remaining relatively flat during the insertion and advancement of the trocar 36. However, in other variants, the adhered tissue may be deployed by the positioning platform 10 and adapted by the substrate 12 to a different configuration, such as a deployed configuration, and the substrate 12 may subsequently lock and maintain that configuration. Even if the tissue configuration is changed, the insertion and advancement of the trocar 36 and the deployment of the positioning guide 26 can be performed in the same procedure as described above.

[0035] The adhesive force 40 generated by the pump 41 to fix the platform 10 to the skin surface S can be kept constant before, during, and / or after the treatment, but the adhesive force can also be arbitrarily changed. FIG. 3D is a side view showing the positioning guide 26 having one or more fluid lines 43 fluidly coupling the platform 10 to the pump 41, as described above. In this variant, however, valves 45, such as check valves or variable control valves, may be incorporated along one or more fluid lines 43 to control the level of the suction force to the skin surface S. The valve 45 may be manually controlled, or the valve 45 may be arbitrarily controlled by a control unit 47 communicating with the valve 45 and the pump 41. The control unit 47 may be programmed, for example, to open and close the valve 45 at a predetermined pressure level, or may be programmed to open and close the valve 45 at a predetermined point in the procedure or by an operation by the user.

[0036] In yet another example, during insertion of the trocar or other instrument, a maximum first vacuum level may be applied so that the platform 10 provides optimal lifting force for the tissue. Once the insertion through the tissue is complete, the vacuum force applied by the platform 10 is adjusted to automatically reduce to a lower second vacuum level, thereby also preventing the formation of wounds and hematomas caused by the platform 10 adhering to the skin surface.

[0037] Side views of FIGS. 4A and 4B illustrate an example where the positioning platform 10 is disposed relative to the tissue surface and adhered to the tissue during a first configuration. In this aspect, the positioning platform 10 may have a flat configuration relative to the skin surface. With one or more suction ports 20 adhered to the tissue by the adhesive force 40, at least one of the positioning guide 26 and the substrate 12 is opened or moved from its initial position so that the positioning platform 10 conforms to the second configuration 50 as shown in FIG. 4B, and the underlying adhered tissue can be conformed accordingly. The substrate 12 may be conformed as described herein to maintain this second configuration 50 and hold or maintain the incised skin in an incised configuration. The positioning platform 10 can be suitably used, for example, as an external tissue incision instrument, for any number of procedures such as breast incision.

[0038] Perspective views of FIGS. 5A and 5B show an alternative positioning platform. In this aspect, the substrate 60 may be formed from any number of biocompatible and flexible materials (e.g., polyethylene, polyvinyl, silicone, etc.) configured to have an adhesive surface 62 for temporary fixation to the skin surface. With the positioning guide 26 extending from the first surface, the second surface 62 may be coated or infused with any number of biocompatible agents or adhesives (e.g., acrylate, cyanoacrylate, silicone, polyurethane, epoxy, etc.) capable of temporarily adhering the second surface 62 to the tissue surface. The substrate 60 may not be adhered via a vacuum force that collapses the layers of the substrate to maintain its shape or form, but the substrate 60 may still be used not only to reconfigure the tissue, for example, by manually reconfiguring the tissue area, but also to open the once-adhered tissue. Further, in this aspect, a pivotal or deflectable positioning guide 26 integral with the substrate 60 may optionally be incorporated.

[0039] Perspective views of FIGS. 6A and 6B show a further alternative example of a substrate 70 having one or more suction ports 20 along a second face of the substrate 70, and a handle 74 secured to a first face of the substrate 70. The vacuum tube attachment 72 is shown as being fluidly coupled along the first face of the substrate 70. In this aspect, the trocar positioning guide 26 and the opening are omitted, such that once the substrate 70 is adhered to the tissue surface, the positioning platform is used as a tissue opener or manipulator. The handle 74 can be configured in any number of forms to allow the user to manipulate the substrate 70 into various positions.

[0040] Figure 7 is a partial side cross-sectional view showing the aspects of FIGS. 6A and 6B to illustrate that the first layer 76 and the second layer 78 can be sealed to each other, for example, around their perimeter, to form a fixing layer 80 therein. As described above, the fixing layer 80 may include any number of substances or elements configured to increase the frictional resistance between these layers when the first layer 76 and the second layer 78 collapse relative to each other. One or more suction ports 20 are each shown to extend from the second surface and are in fluid communication with the fixing layer 80 between the first layer 76 and the second layer 78, respectively.

[0041] FIGS. 8A and 8B are perspective views showing a further alternative substrate 90 similar to the substrate 60 described herein. In this aspect, by incorporating the handle 74 into the substrate 90, the positioning platform can be utilized as, for example, a tissue dissection instrument or a manipulator once adhered to the tissue surface.

[0042] Top and side views of FIGS. 9A - 9C show a positioning platform according to yet another example configured for tissue creation and / or manipulation. Substrate 100 according to this aspect may incorporate a handle 102 protruding from a first surface of substrate 100. Also, as shown in the top view of FIG. 9A, a vacuum tube attachment 104 protruding from the first surface and in fluid communication with the interior of the substrate is shown. The second surface of substrate 100 may be configured to have, for example, an adhesive (described herein) for temporary attachment to the tissue surface. The side view of FIG. 9B is a detailed cross - sectional view showing that the interior of substrate 100 may be filled with particulate material such as beads 106 (formed from any of a variety of materials such as plastic, polymer, etc.) that are free to move relative to each other and are contained between a first layer 101 and a second layer 103 of substrate 100. As shown, beads 106 are shown to be able to move freely before their interior is collapsed by a vacuum force, thereby allowing the substrate 100 to conform to the anatomical tissue structure when the substrate 100 is placed on the tissue surface. Once the beads 106 are adhered to the tissue surface in a state where they are free to move without restraint, the handle 102 can be operated to reconfigure the substrate 100, for example, to create the desired tissue site. As shown in FIG. 9C, a vacuum force may be applied to the interior of substrate 100' while maintaining the handle 102 in a reconfigured shape until the layers 101, 103 collapse relative to each other and relative to the contained beads 106. The beads 106 may collapse relative to each other, for example, to increase frictional resistance, force the substrate 100' to maintain the reconfigured shape, and force the adhered tissue to maintain the same reconfigured shape, for example, to maintain the forcibly created state. Once the vacuum force is removed and air re - enters the interior of substrate 100, the shape of substrate 100 may relax, and the adhered tissue may flatten or return to its original shape.

[0043] Next, FIGS. 10A and 10B are various perspective views showing the structure of an individual suction assembly 22 according to one aspect. The suction assembly 22 may be formed to have a suction housing 110 that protrudes to form a suction chamber 112 for placement against the surface of the tissue to be adhered. The suction housing 110 can form any number of cross-sectional shapes (e.g., circular, elliptical, rectangular, polygonal, etc.) suitable for the formation of the suction chamber 112, and may protrude distally from a lower housing 114 having a lower shoulder 116 that protrudes radially to form the lower outer peripheral portion of the lower housing 114. An upper housing 118 may be attached to the lower housing 114 and, similarly, may have an upper shoulder 120 that protrudes radially to form the upper outer peripheral portion of the upper housing 118. A substrate attachment portion 122 for attachment to the first and second layers of the substrate may be formed between the lower shoulder 116 and the upper shoulder 120. Additionally, one or more fluid channels 124 for fluid communication with the interior of the fixed layer 18 may be provided on the outer peripheral portion of the substrate attachment portion 122. The lower housing 114 and the upper housing 118 are shown as having an annular form with respect to the suction housing 110, but the lower housing 114 and the upper housing 118 may be formed to have other shapes or forms.

[0044] FIG. 11 is a side cross-sectional view showing a suction assembly attached to a substrate. As shown, the first layer 14 may adhere around the upper shoulder 120 to form a liquid-tight seal, and the second layer 16 may adhere around the lower shoulder 116 to also form a liquid-tight seal. Also, one or more fluid channels 124 formed around the outer periphery of the substrate attachment portion 122 may maintain a fluid communication state with the inside of the fixed layer 18. Between the floor portion 130 of the lower housing 114 and the upper housing 118, for example, a housing chamber 134 with a valve 136, for example an umbrella valve, may be formed. This valve may be biased towards the floor portion 130 and maintain the valve 136 in a closed configuration relative to the floor portion 130. A holding member 138 protruding from the valve 136 may extend partially into the suction chamber 112 through an opening 132 provided through the floor portion 130. The holding member 138 may be configured to include an expanded holding portion such that the valve 136 can move between the open and closed configurations until the expanded portion of the holding portion contacts the opening 132 and limits the amount by which the valve 136 opens.

[0045] During use when a vacuum force is applied to the substrate, air or gas within the fixed layer 18 and also within the housing chamber 134 can be exhausted by urging the valve 136 into an open configuration that extends into the interior of the housing chamber 134 while being restricted in movement by the expanded holding portion of the holding member 138. With the valve 136 thus opened, air or gas within the suction chamber 112 is exhausted through the floor portion 130, through the housing chamber 134, and through one or more openings exiting from one or more fluid channels 124, so that the suction housing 110 may be adhered to the underlying tissue surface by the negative pressure generated within the suction chamber 112. The valve 136 is optionally biased in a closing direction with respect to the floor portion 130 once the suction pressure reaches equilibrium between the housing chamber 134 and the suction chamber 112 (or when the suction pressure becomes lower than the biasing closing force of the valve 136), and the valve 136 may close with respect to the floor portion 130 to seal the suction chamber 112 and the housing chamber 134. In this way, the suction fixation between the suction housing 110 and the adhered tissue surface may be maintained individually between each suction assembly 22 and the tissue surface. This is particularly useful in the event that the vacuum pressure is lost within the fixed layer 18 during the procedure, since the individual suction assemblies 22 can maintain suction adhesion to the tissue surface independently of each other.

[0046] Alternative suction assemblies 140 are shown in various perspective views of FIGS. 12A and 12B, which illustrate a suction housing 142 that forms a suction chamber 144 similarly formed from a lower housing 146 having a lower shoulder 148. An upper housing 150 having an upper shoulder 152 may be attached to the lower housing 146 and may form a substrate attachment portion 154 around the outer periphery of the housing assembly. Also, one or more fluid channels 156 may be provided around the outer periphery of the substrate attachment portion 154.

[0047] As shown in the side cross-sectional view of FIG. 13, the valve 166 is configured and arranged within the housing chamber 164 such that the height between the lower shoulder 148 and the upper shoulder 152 can be reduced relative to the above-described embodiment, while still being in fluid communication through the fixed layers 18 and the one or more fluid channels 156. Also, by reducing the height, the thickness of the substrate can be made relatively thinner. In this case, the outer seal surface 170 of the seal member 168 may be urged against the opening 162 provided on the lower housing 160 to remain in the closed state. The seal member 168 is configured in a conical shape protruding from the valve body and can urge the valve 166 to open when a vacuum is applied to the substrate. The negative pressure in the suction chamber enables the underlying tissue surface to be adhered to the suction housing. As described above, when the suction pressure reaches equilibrium between the housing chamber 164 and the suction chamber 144 (or when the suction pressure becomes lower than the biasing closing force of the valve 166), the valve 166 may close against the floor 160 to seal the suction chamber 144 and the housing chamber 164. Thereby, the individual suction assemblies can be adhered to the tissue surface.

[0048] As described above, the vacuum tube attachment portion may be coupled to the substrate to provide fluid communication between the pump and the fixed layer of the substrate and the suction assembly. The vacuum tube attachment portion can be coupled to any location on the substrate, although the attachment portion can also be coupled to one of the suction assemblies. FIG. 14 is a side cross-sectional view showing one embodiment in which a vacuum tube 182 having a lumen 184 may be directly attached to at least one of the suction assemblies. The distal end of the tube 182 is attached to the housing of the suction assembly, and the lumen 184 may be in direct fluid communication with the housing chamber 164. The proximal end of the tube 182 is fluidly connected to a fluid line to communicate with the pump, and when the pump is activated, a vacuum force may be applied through the lumen 184 and the attached suction assembly. Since the suction assembly is in fluid connection with the fixed layer and other suction assemblies, the vacuum force may be appropriately applied to the entire substrate and suction assembly.

[0049] Next, turning to other uses or embodiments of the positioning platform 10, various laparoscopic surgeries may be facilitated using any of the embodiments of the platform described herein. In certain procedures, the platform may be used to establish a pneumoperitoneum in the patient to create a pneumoperitoneal cavity as part of the preparation for abdominal (or other cavity) procedures. The operator typically identifies a location along the patient's body, such as the abdomen, where an instrument like a Veress needle is to be inserted through the skin until the tip reaches just inside the peritoneum. If the operator blindly inserts the needle, unexpected trauma can occur. For example, if a portion of the intestine is adhered to the inner wall of the peritoneum, inserting the needle over the adhesion can cause a hole or injury to the intestine.

[0050] Once the needle is properly positioned within the patient's body, the cavity can be inflated through the needle and a primary trocar can be blindly inserted into the peritoneum. In the case of a patient with adhesions, the trocar can cause the same complications as needle insertion. Subsequently, another instrument, such as a laparoscopic camera, can be inserted into the peritoneum through the primary trocar, which may facilitate the insertion of additional trocars into the patient under direct vision to reduce the risk of internal injury.

[0051] With the positioning platform 10 adhered to the skin surface S, the platform 10 can be used to lift the site of the tissue where the needle and / or trocar is to be inserted, making it easier to separate any intestinal tissue from the interior of the abdominal wall. Also, by lifting the tissue site, the operator is assisted in evaluating whether there are adhesions present prior to inserting the needle and / or trocar.

[0052] As an example, as shown in the side view of FIG. 15, the platform 10 is applied to the skin surface S, the adhered tissue is lifted, and it is exemplified that the skin surface S is lifted so as to be separated from the patient in order to give feedback regarding the presence of the adhesion part. After the evaluation is once made, the needle 190 may be inserted through the positioning guide 26 until the penetrating tip 192 or the blunt tip 194 of the needle passes through the inner wall of the tissue while avoiding the adhesion part. Instead of this, once the evaluation on the platform 10 is completed, the platform 10 may be removed from the tissue site, and the needle 190 may be directly inserted into the skin surface S and penetrated therethrough.

[0053] In another modification, the platform 10 may be directly used in combination with an imaging instrument such as the laparoscope 200 as shown in the side view of FIG. 16. After inserting the trocar through the skin surface S, the trocar may be removed while leaving the cannula sleeve 202 at a predetermined position through the tissue site. The laparoscope 200 may be directly inserted, for example, through the cannula sleeve 202 in order to directly observe the inside of the body cavity.

[0054] In yet another alternative, platform 10 may be used in combination with an imaging device such as ultrasonic transducer 212 that is communicable with control unit 47 (as described above) or an individual ultrasonic control unit 214, as shown in the perspective view of FIG. 17. The ultrasonic transducer 212 can be used, for example, to determine whether there is an adherent portion under the skin surface prior to applying platform 10 to the tissue surface. The ultrasonic transducer 212 can be first applied to the skin and then removed to enable the use of platform 10, but in other variations, the ultrasonic transducer 212 may be directly incorporated into platform 10. As one aspect, it has been shown that one or more openings 210 may be formed through platform 10 adjacent to positioning guide 26, and ultrasonic transducer 212 may be provided integrally with platform 10 at one of the openings 210. The transducer 212 may be used for real-time imaging of the tissue site directly under platform 10 before and during trocar insertion while platform 10 is directly adhered to the skin surface S.

[0055] Upon removal of the trocar, gas from the pneumoperitoneum may be discharged through the opening or leak from the opening. To maintain a liquid-tight seal through the opening in the tissue or the trocar and maintain the pneumoperitoneum, a seal or stopper may be inserted to cover the opening of the trocar or directly over the opening in the tissue. At the end of the procedure, the abdominal wall opening (e.g., greater than 12 mm) can be sutured closed.

[0056] The uses of the disclosed invention described above are not limited to specific procedures or body parts and can include any number of other procedures and body parts. Modifications of the methods and apparatuses described above for practicing the present invention, and variations of aspects of the present invention that are apparent to those skilled in the art, are intended to be within the scope of this disclosure. Further, various combinations of aspects between the examples are also envisioned and are likewise considered to be within the scope of this disclosure.

Claims

1. A substrate having a first surface and a second surface opposite the first surface, wherein the second surface is configured to releasably adhere to a tissue surface, and the interior of the substrate is in fluid communication through an opening provided in the substrate, wherein the substrate is configured to maintain a predetermined form when a vacuum force is applied, an apparatus for creating a tissue site.

2. The apparatus according to claim 1, wherein the substrate is provided with a fixing layer between the first surface and the second surface.

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

4. The apparatus according to claim 3, wherein the fixing layer is composed of a screen, a mesh, beads, grooves, channels, or protrusions.

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

6. The apparatus according to claim 1, wherein the second surface is composed of an adhesive for releasably adhering to the tissue surface.

7. The apparatus according to claim 1, further comprising one or more suction assemblies disposed along the second surface and in fluid communication with the interior of the substrate.

8. The apparatus according to claim 7, wherein each of the one or more suction assemblies includes a valve biased to maintain a closed form.

9. The apparatus according to claim 1, further comprising a handle extending from the first surface.

10. The apparatus according to claim 1, further comprising an ultrasonic transducer provided integrally with the substrate and arranged to detect elements within a tissue site.

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