Innovator device

Abstract

Trocar retractor devices and methods of use are described. The device for positioning an instrument 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 disposed along the second surface and in fluid communication with the interior of the substrate. The one or more suction assemblies are attachable to a tissue region by applying vacuum force through the one or more suction assemblies. The device is also configured to maintain a predetermined configuration of the substrate when vacuum force is applied.

Description

[Technical field]

[0001] The present invention relates generally to medical devices and methods, and more particularly to devices and methods for locating trocar devices and tissue sites. [Background technology]

[0002] Trocars are commonly used to access internal body lumens through the skin surface during surgical procedures such as laparoscopic procedures. Typically, trocars include 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 abdominal cavity, the obturator may be dislodged from the cannula leaving an access path through the cannula into the body cavity. Unfortunately, trocars typically do not provide any indication of the trocar penetration depth to a user who must estimate the penetration depth during and after abdominal wall penetration.

[0003] Additionally, trocar insertion can cause puncture trauma to the underlying organs and structures, which can lead to complications. For example, laparoscopic trocar insertion can injure the underlying intestine and cause bleeding in various blood vessels. This problem is further complicated by the tendency of tissue to collapse or dent around the trocar as it is inserted into the tissue.

[0004] To reduce the incidence of unintentional perforation, surgeons can establish a pneumoperitoneum by insufflating the abdomen with gas, which expands the space between the interior of the abdominal wall and the viscera below it, to provide space for a trocar to penetrate the abdominal wall and reach the top of the organs. Pneumoperitoneum is typically accomplished with a Veress needle, which is used to penetrate the abdominal cavity and deliver gas, but this needle also has the same potential complications as trocar insertion.

[0005] Once the body wall has been penetrated, the obturator can be removed, leaving a cannula that penetrates the body and can accept any number of surgical instruments. However, guide tubes are subject to unintended or undesirable movement, such as changes in penetration depth or accidental withdrawal from the body. Summary of the Invention [Problem 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 while reducing the risk of damage to the underlying tissue. There is also a need for a device that allows for location and retraction of tissue sites during a procedure without risk of injury or inadvertent movement. [Means for solving the problem]

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

[0008] The substrate can be formed in various shapes, such as circular, elliptical, rectangular, pentagonal, hexagonal, octagonal, etc., as long as it can be favorably positioned on the target tissue site. The substrate can be formed in various configurations, but in the illustrated embodiment, it can be composed of a first flexible layer and a second flexible layer located on the opposite side of the first layer, with a fixation layer formed therebetween, and the first and second layers can be configured to slide relative to each other. The first and second layers can be fixed or otherwise sealed to each other at their periphery such that the fixation layer therebetween forms an airtight chamber in fluid communication with each of the one or more suction ports. The fixation layer can be completely or at least partially filled with a material that limits sliding between the first and second layers, such as a screen, mesh, beads, grooves, channels that are lateral or angled relative to each other, protrusions on opposing surfaces, or any substance or element that increases frictional resistance between the first and second layers. When a mesh layer is used as the anchoring layer, there is no minimum thickness or porosity of the mesh, so long as it provides sufficient frictional resistance to movement between the first and second layers when collapsed by vacuum forces.

[0009] When the substrate is initially positioned against the tissue site, the first and second layers can slide freely against each other and against the fixation layer, allowing the substrate to conform to the tissue structure of the underlying adherent tissue. Once a vacuum force, for example 600-650 mmHg (about 80 kPa-86.6 kPa), is applied through the substrate via a fluidly coupled vacuum line, the one or more suction ports may adhere to the underlying tissue by negative pressure, causing the first and second layers to collapse on or toward each other. The fixation layer may be provided to increase the frictional resistance between the contacting inner surfaces of the first and second layers against each other and against the fixation layer, such that the substrate freezes in the reconstituted shape. When the substrate is reconstituted to conform to the structure of the underlying tissue or to a different shape, application of negative pressure may cause the first and second layers to collapse, allowing the substrate to maintain its shape while the vacuum is applied. If the substrate is adhered to the underlying tissue in a flat configuration, negative pressure may be applied to collapse the first and second layers so that the flat configuration is maintained. Once the vacuum force is released or the pressure is increased, the first and second layers release from each other and from the fixation layer, allowing the substrate to be released from the tissue and return to a shape that provides flexibility for removal from or attachment to the tissue or another portion of the tissue.

[0010] The base plate may further define one or more channels or openings extending from the outer periphery of the base plate toward the pneumoperitoneum / trocar positioning guide to further provide flexibility to the base plate. Additionally, the trocar positioning guide may project from the base plate, e.g., laterally or at an angle to the base plate, forming a trocar channel that defines a lumen through the base plate through which the trocar may pass and enter the tissue beneath. The positioning guide may also have a shoulder projecting radially from the proximal portion of the trocar channel, which provides a handle for facilitating manipulation and adjustment of the positioning guide and base plate by the user, and also facilitates insertion of the trocar into the trocar channel. The trocar channel may further define an opening or slit along the channel to position the trocar at an angle in a controlled manner relative to the base plate 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. Additionally, multiple interchangeable guides may be provided for specific applications or procedures to improve access or retraction, such as retraction for tissue positioning, pneumoperitoneum, trocar placement, or facia closure.

[0011] In one use example, 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, e.g., on the skin surface, such that the positioning guide protrudes away from the skin surface. A vacuum force may be activated via a pump fluidly coupled via one or more fluid lines, and applied through the substrate such that the one or more suction ports create an adhesive force to secure the substrate on the skin surface. The substrate may be positioned to ensure that the opening of the positioning guide is aligned directly over the site of tissue to be punctured by the trocar.

[0012] With the positioning platform positioned in this manner, an insertion force may be applied to the trocar while the trocar is advanced through the positioning guide toward the tissue site to be accessed. At the same time, a counter force may be applied directly to the positioning guide in a direction opposite to the insertion force. With the tissue attached to one or more suction ports and with a counter force applied in a direction opposite to the insertion force from the trocar, the tissue may be maintained in a relatively neutral state as the trocar is further inserted through the skin surface and into the tissue. That is, the tissue may be prevented from indenting or further collapsing into the body as the trocar is initially inserted and advanced into the tissue. This may further prevent inadvertent insertion, damage, or tearing of tissue structures during trocar insertion. After the trocar is inserted into the tissue, the vacuum level may be optionally reduced from the initial level.

[0013] Alternative positioning platforms may utilize a substrate formed from any number of biocompatible and flexible materials (e.g., polyethylene, polyvinyl, silicone, etc.) configured with an adhesive surface for temporary fixation to a skin surface. With the positioning guide extending from the first surface, the second surface may be coated or infused with any number of biocompatible agents or adhesives (e.g., acrylates, cyanoacrylates, silicones, polyurethanes, epoxies, etc.) that may temporarily adhere the second surface to the tissue surface. Although the substrate may not be adhered via vacuum forces that collapse layers of the substrate to maintain shape or form, the substrate may still be used to retract tissue once adhered, as well as remodel tissue, for example, by manually remodeling tissue areas. Additionally, the present embodiment may optionally incorporate a pivoting or redirecting positioning guide integral with the substrate.

[0014] Yet another alternative is to utilize a handle secured to the first surface of the substrate. In this embodiment, the trocar positioning guide and opening are eliminated, whereby the positioning platform is used as a tissue retractor or manipulator once the substrate is adhered to the tissue surface. The handle can be configured in any number of configurations to allow the user to manipulate the substrate into various positions.

[0015] As yet another alternative, the substrate may incorporate a handle that protrudes from a first surface of the substrate. The second surface of the substrate may be configured with, for example, an adhesive (as described herein) for temporary attachment to a tissue surface. The interior of the substrate may be filled with particulate material, such as beads (formed from any of a variety of materials, such as plastics, polymers, etc.), that are free to move relative to one another and are contained between the first and second layers of the substrate. The beads are free to move before collapsing due to the force of the vacuum, allowing the substrate to conform to the anatomical tissue structure when placed on the tissue surface. Once the beads are attached to the tissue surface with no constraints on their free movement, the handles may be manipulated to reconfigure the substrate, for example, to retract the tissue site of interest. Alternatively, a vacuum force may be applied to the substrate interior while holding the handle portion in the reconfigured shape until the layers collapse against one another and against the contained beads. The beads may collapse against one another to increase frictional resistance and force the substrate to maintain the reconfigured shape and to force the attached tissue to maintain the same reconfigured shape, for example, to remain retracted. Once the vacuum force is removed and air is allowed to re-enter the interior of the substrate, the substrate may relax in shape and the attached tissue may flatten or return to its original shape.

[0016] An apparatus for positioning an instrument according to one embodiment may generally include 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 an interior of the substrate, the one or more suction assemblies being 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 upon application of a vacuum force.

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

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

[0019] Yet another device for retracting a tissue region 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 an interior of the substrate, the one or more suction assemblies attachable to the tissue site via a vacuum force applied through the one or more suction assemblies, the substrate configured to retain a predetermined configuration when the vacuum force is applied.

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

[0021] In all embodiments, it is anticipated that the amount of vacuum required will vary from procedure to procedure, e.g., higher vacuum levels may be required during retraction, while lower vacuum levels may be required to maintain position on the tissue and / or maintain tissue-trocar orientation. This may be accomplished, for example, by direct adjustment of the vacuum level on the vacuum source, or by a user-activated valve integrally incorporated into the device itself that allows for variable or preset vacuum levels. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of a trocar positioning and retraction platform according to one embodiment. [Figure 2A] FIG. 2A is a perspective view of a trocar positioning and retraction platform, with the trocar shown angled relative to the platform. [Figure 2B]FIG. 2B is a side view of the trocar positioning and retraction platform, showing the trocar angled relative to the platform. [Figure 3A] 3A-3C are side views illustrating one example of how a platform may be used to provide a counter force to a trocar during insertion through tissue. [Figure 3B] 3A-3C are side views illustrating one example of how a platform may be used to provide a counter force to a trocar during insertion through tissue. [Figure 3C] 3A-3C are side views illustrating one example of how a platform may be used to provide a counter force to a trocar during insertion through tissue. [Figure 3D] FIG. 3D is a side view showing a platform assembly in communication with a controllable valve for varying the suction force applied through the platform. [Figure 4A] 4A and 4B are side views illustrating an alternative method in which the platform is used as a retraction device to hold a tissue section in place. [Figure 4B] 4A and 4B are side views illustrating an alternative method in which the platform is used as a retraction device to hold a tissue section in place. [Figure 5A] 5A and 5B are various perspective views illustrating a trocar positioning and retraction platform according to yet another embodiment. [Figure 5B] 5A and 5B are various perspective views illustrating a trocar positioning and retraction platform according to yet another embodiment. [Figure 6A] 6A and 6B are various perspective views illustrating a platform according to yet another embodiment configured for retracting and manipulating tissue. [Figure 6B] 6A and 6B are various perspective views illustrating a platform according to yet another embodiment configured for retracting and manipulating tissue. [Figure 7]FIG. 7 is a detailed side view of the platform showing an example of a fixing mechanism. [Figure 8A] 8A and 8B are various perspective views illustrating yet another example platform configured for retracting and manipulating tissue. [Figure 8B] 8A and 8B are various perspective views illustrating yet another example platform configured for retracting and manipulating tissue. [Figure 9A] FIG. 9A is a top view of yet another alternative platform configured for retracting and manipulating tissue. [Figure 9B] FIG. 9B is a side view of yet another alternative platform configured for retracting and manipulating tissue. [Figure 9C] FIG. 9C is a side view of the platform of FIGS. 9A and 9B illustrating a method of reconfiguration of the platform to maintain its shape against the tissue site. [Figure 10A] 10A and 10B are various perspective views illustrating a separate suction mechanism for temporarily adhering to a tissue site. [Figure 10B] 10A and 10B are various perspective views illustrating a separate suction mechanism for temporarily adhering to a tissue site. [Figure 11] FIG. 11 is a side cross-sectional view showing the suction mechanism of FIGS. 10A and 10B. [Figure 12A] 12A and 12B are various perspective views illustrating a separate suction mechanism according to another embodiment for temporarily adhering to a tissue site. [Figure 12B] 12A and 12B are various perspective views illustrating a separate suction mechanism according to another embodiment for temporarily adhering to a tissue site. [Figure 13] FIG. 13 is a side cross-sectional view showing the suction mechanism of FIGS. 12A and 12B. [Figure 14] FIG. 14 is a side cross-sectional view showing a separate suction mechanism according to another embodiment. [Figure 15]FIG. 15 is a side view showing a platform used in combination with a needle. [Figure 16] FIG. 16 is a side view showing a platform for use in combination with an imaging instrument such as a laparoscope. [Figure 17] FIG. 17 is a perspective view of a platform having an integral ultrasound transducer for imaging during use with the platform. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] In accessing sites within a patient's body, trocar devices are commonly used to provide access to the body for various surgical instruments, such as laparoscopic instruments. When inserting a trocar through the skin and tissue layers, there is a risk that the trocar may unintentionally damage the underlying tissue. Furthermore, once inserted through the skin surface and into the patient's body, the trocar and / or instruments may be repositioned or angled relative to the underlying tissue as desired. Additionally, during a surgical procedure, the tissue underlying the skin may be retracted or temporarily moved as desired to facilitate access to the subject.

[0024] A trocar positioning platform according to one embodiment, which may also be used for retracting or positioning tissue, is shown in perspective view in FIG. 1. The positioning platform 10 is shown as a substrate 12 having a first surface from which a trocar positioning guide 26 extends and a second surface configured to releasably draw a vacuum via one or more suction ports 20 that may be adhered onto a tissue surface for temporary fixation. A pump or negative pressure mechanism located at a location remote from the substrate 12 may be fluidly coupled to the substrate 12 via one or more fluid lines to provide the vacuum force. The one or more suction ports 20 may be distributed on the substrate 12 in a uniform, random, or any number of predetermined specific configurations. Each of the one or more suction ports 20 may be provided with a chamber formed by a separate suction assembly 22. The number of suction ports 20 may vary from one to multiple, but the substrate 12 according to one embodiment may incorporate, for example, 21 to 25 suction ports.

[0025] The substrate 12 can be formed into various shapes, such as a circle, an oval, a rectangle, a pentagon, a hexagon, an octagon, etc., as long as it can be preferably positioned on the target tissue site. Although the substrate 12 can be formed into various configurations, in the illustrated embodiment, the substrate 12 can be composed of a first flexible layer 14 and a second flexible layer 16 located on the opposite side of the first layer 14, with a fixation layer 18 formed therebetween, and the first layer 14 and the second layer 16 can be configured to slide relative to each other. The first layer 14 and the second layer 16 can be fixed or otherwise sealed to each other at their peripheries such that the fixation layer 18 therebetween forms an airtight chamber in fluid communication with each of the one or more suction ports 20. The retaining layer 18 may be completely or at least partially filled with a material that limits sliding between the first layer 14 and the second layer 16, such as a screen, mesh, beads, grooves, channels that are lateral or angled relative to one another, protrusions on opposing surfaces, or any substance or element that increases frictional resistance between the first layer 14 and the second layer 16. When a mesh layer is used as the retaining layer 18, there is no minimum thickness or porosity of the mesh, so long as it provides sufficient frictional resistance to movement between the first layer 14 and the second layer 16 when collapsed by the force of a vacuum.

[0026] Upon initial positioning of the substrate against a tissue site, the first layer 14 and the second layer 16 may slide freely relative to each other and relative to the fixation layer 18, allowing the substrate 12 to conform to the tissue structure of the underlying adherent tissue. Once a vacuum force, e.g., 600-650 mmHg (approximately 80-86.6 kPa) is applied through the substrate 12 via a fluidly coupled vacuum line, the one or more suction ports 20 may adhere to the underlying tissue via negative pressure and the first layer 14 and the second layer 16 may collapse onto or towards each other. The fixation layer 18 may be provided to increase the frictional resistance between the contacting inner surfaces of the first layer 14 and the second layer 16 against each other and against the fixation layer 18, such that the substrate 12 freezes in the reconstituted shape. When the substrate 12 is reconstituted to conform to the structure of the underlying tissue or to a different shape, application of negative pressure may cause the first layer 14 and the second layer 16 to collapse, allowing the substrate 12 to maintain its shape while the vacuum is applied. If substrate 12 is adhered to underlying tissue in a flat configuration, negative pressure may be applied to collapse first layer 14 and second layer 16 such that the flat configuration is maintained. Once the vacuum force is released or the pressure is increased, first layer 14 and second layer 16 release from each other and from fixation layer 18, allowing substrate 12 to be released from the tissue and return to a flexible shape for removal from or attachment to the tissue or another portion of the tissue.

[0027] The substrate 12 may further define one or more channels or openings 24 extending from the outer periphery of the substrate 12 toward the trocar positioning guide 26 to further provide flexibility to the substrate 12. Additionally, the trocar positioning guide 26 may project from the substrate 12, e.g., laterally or at an angle relative to the substrate 12, such that the positioning guide 26 defines a trocar channel 30 that defines a lumen 32 through the substrate 12 to allow a trocar 36 to pass through and enter the underlying tissue. The trocar 36 may be shown extending through the trocar channel 30 with the trocar distal tip 38 wedged beyond the substrate 12 into the underlying tissue. The positioning guide 26 may also have a shoulder 28 that projects radially from the proximal portion of the trocar channel 30 to provide a handle for facilitating manipulation and adjustment of the positioning guide 26 and substrate 12 by the user, and to facilitate insertion of the trocar 36 into the trocar channel 30. Trocar channel 30 may further include an opening or slit 34 along the channel 30 for positioning trocar 36 at a controlled angle relative to base plate 12 and trocar positioning guide 26. Thus, the width of opening or slit 34 along trocar channel 30 may have a dimension that is the same as or slightly larger than the diameter of trocar 36 itself.

[0028] 2A and 2B are perspective and side views of the substrate 12 and a trocar 36 at an angle relative to the substrate 12. With the substrate 12 adhered to the tissue surface, the trocar 36 can be inserted at an angle relative to the substrate 12 and / or the tissue surface, and 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 after insertion. In either case, the trocar 36 may be positioned such that the longitudinal axis of the trocar 36 is angled at an angle θ relative to the longitudinal axis of the positioning guide 26. The angle θ may range anywhere from, for example, 0 degrees to nearly 90 degrees depending on the desired position of the trocar 36. 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.

[0029] One example is shown in side view in Figures 3A-3C, illustrating how the trocar positioning platform 10 may be used to retract tissue during insertion of a trocar 36 into an associated target tissue site. As shown in Figure 3A, the platform 10 may be positioned over the associated 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. A vacuum force may be activated via a pump 41 fluidly coupled via one or more fluid lines 43, and applied through the substrate 12 such that the one or more suction ports 20 generate an adhesive force 40 to secure the substrate 12 to the skin surface S. The substrate 12 may be positioned to ensure that the opening of the positioning guide 26 is located directly over the portion of the tissue to be pierced by the trocar 36.

[0030] With the positioning platform 10 positioned in this manner, the trocar 36 may be advanced through the positioning guide 26 toward the tissue site to be accessed while an insertion force 44 is applied to the trocar 36. At the same time, a counter force 42 may be applied directly to the positioning guide 26 in a direction opposite to the insertion force 44, as shown in FIG. 3B. With the tissue attached to one or more of the suction ports 20 and with the counter force 42 applied in a direction opposite to the insertion force 44 from the trocar 36, as shown in FIG. 3C, the tissue may be maintained in a relatively neutral state as the trocar 36 is further inserted through the skin surface S and into the tissue. That is, the tissue may be prevented from indenting or further collapsing into the body as the trocar 36 is initially inserted and advanced into the tissue. This may further prevent inadvertent insertion, damage, or tearing of tissue structures during insertion of the trocar 36. After the trocar 36 is inserted into the tissue, the vacuum level may be optionally reduced from the initial level.

[0031] Once the trocar 36 is inserted into and through tissue, the relatively large diameter of the trocar 36 can "tent" the tissue into the patient as the tip of the trocar 36 is pushed through the abdomen. Although the force required to insert the trocar 36 increases significantly depending on the amount of tenting, the practitioner can minimize not only lifting the tissue (and further aiding in moving the internal organs out of the way), thus reducing the force required to insert the trocar 36 and the likelihood that the trocar 36 will breach the peritoneum and over-insert the trocar 36 into the patient's body.

[0032] When a pivoting positioning guide (as described herein) is utilized with the base plate 12, the orientation of the positioning guide can be changed before, during, or after insertion and / or advancement of the trocar 36 into the tissue to change the direction of trocar insertion into the tissue.

[0033] In one embodiment, the trocar 36 can be advanced using one hand of the user and the positioning guide 26 can be retracted using the other hand of the user. In another variation, the insertion and advancement of the trocar 36 as well as the retraction of the positioning guide 26 can be performed with one hand of the user. In yet another variation, both the insertion of the trocar 36 and the retraction of the positioning guide 26 can be performed by a different user.

[0034] The tissue surface S is illustrated as remaining relatively flat during insertion and advancement of the trocar 36. However, in other variations, the attached tissue may be retracted by the positioning platform 10 and conformed by the substrate 12 to a different configuration, such as a retracted configuration, which is then locked and maintained by the substrate 12. Despite the change in tissue configuration, insertion and advancement of the trocar 36 and retraction of the positioning guide 26 can be performed in the same manner as described above.

[0035] The adhesive force 40 generated by the pump 41 to secure the platform 10 to the skin surface S can be kept constant before, during, and / or after treatment, although the adhesive force can be optionally varied. FIG. 3D is a side view of the positioning guide 26 with one or more fluid lines 43 fluidly coupling the platform 10 to the pump 41, as previously described, but in this variation, a valve 45, such as a check valve or a variable control valve, can be incorporated along the one or more fluid lines 43 to control the level of suction to the skin surface S. The valve 45 can be manually controlled, or the valve 45 can be optionally controlled by a controller 47 in communication with the valve 45 and the pump 41. The controller 47 can be programmed, for example, to open and close the valve 45 at a predetermined pressure level, or to open and close the valve 45 at a predetermined time in the procedure or upon user action.

[0036] In yet another example, a maximum first vacuum level may be applied during insertion of a trocar or other instrument such that platform 10 provides optimal lifting force on tissue. Once insertion through the tissue is complete, the vacuum force applied by platform 10 may be automatically adjusted to reduce to a lower second vacuum level, which may also prevent bruising or hematoma formation caused by platform 10 adhering to the skin surface.

[0037] The side views of Figures 4A and 4B illustrate an example in which the positioning platform 10 is placed against a tissue surface and adhered to the tissue while in a first configuration. In this embodiment, the positioning platform 10 may have a flat configuration against the skin surface. With one or more suction ports 20 adhered to the tissue by adhesive forces 40, the positioning guide 26 and / or substrate 12 may be retracted or moved from their initial positions such that the positioning platform 10 conforms to a second configuration 50 as shown in Figure 4B and conforms the underlying adherent tissue accordingly. The substrate 12 may be adapted as described herein to maintain this second configuration 50 and hold or maintain the adherent skin in a retracted configuration. The positioning platform 10 may be suitably used for any number of procedures, such as for breast retraction, for example, as an external tissue retractor.

[0038] An alternative positioning platform is shown in perspective views in Figures 5A and 5B. In this embodiment, the substrate 60 may be formed from any number of biocompatible and flexible materials (e.g., polyethylene, polyvinyl, silicone, etc.) configured with an adhesive surface 62 for temporary fixation to a 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., acrylates, cyanoacrylates, silicones, polyurethanes, epoxies, etc.) that may temporarily adhere the second surface 62 to a tissue surface. Although the substrate 60 may not be adhered via vacuum forces that collapse the substrate layers to maintain shape or form, the substrate 60 may still be used to retract tissue once adhered, as well as remodel tissue, for example, by manually remodeling tissue areas. Additionally, this embodiment may optionally incorporate a pivoting or redirecting positioning guide 26 integral with the substrate 60.

[0039] 6A and 6B, perspective views show yet another embodiment of a substrate 70 having one or more suction ports 20 along a second side of the substrate 70 and a handle 74 secured to a first side of the substrate 70. A vacuum tube attachment 72 is shown as being fluidly coupled along the first side of the substrate 70. In this embodiment, the trocar positioning guide 26 and openings are omitted, such that the positioning platform is used as a tissue retractor or manipulator once the substrate 70 is adhered to a tissue surface. The handle 74 can be configured in any number of configurations to allow a user to manipulate the substrate 70 into various positions.

[0040] 7 is a partial cross-sectional side view of the embodiment of FIGS. 6A and 6B to illustrate that the first layer 76 and the second layer 78 can be sealed to one another, e.g., at their peripheries, to form an anchoring layer 80 therein. As discussed above, the anchoring layer 80 can include any number of materials or elements configured to increase frictional resistance between the first layer 76 and the second layer 78 when the layers collapse against one another. One or more suction ports 20 are shown extending from the second surface, respectively, and are in fluid communication with the anchoring layer 80 between the first layer 76 and the second layer 78, respectively.

[0041] 8A and 8B are perspective views of yet another alternative substrate 90, similar to substrate 60 described herein. In this embodiment, handles 74 may be incorporated into substrate 90 to allow the positioning platform to be utilized, for example, as a tissue retractor or manipulator, once attached to a tissue surface.

[0042] 9A-9C show a further example positioning platform configured for retracting and / or manipulating tissue in top and side views. The substrate 100 according to this embodiment may incorporate a handle 102 protruding from a first surface of the substrate 100. Also shown in the top view of FIG. 9A is a vacuum tube attachment 104 protruding from the first surface and in fluid communication with the interior of the substrate. The second surface of the substrate 100 may be configured with, for example, an adhesive (as described herein) for temporary attachment to a tissue surface. The side view of FIG. 9B is a detailed cross-sectional view showing that the interior of the substrate 100 may be filled with particulate material such as beads 106 (formed from any of a variety of materials such as plastics, polymers, etc.) that are free to move relative to one another and are contained between the first layer 101 and the second layer 103 of the substrate 100. As shown, the beads 106 are shown to be free to move before collapsing due to vacuum forces, thereby allowing the substrate 100 to conform to the anatomical tissue structure when placed on the tissue surface. Once the beads 106 are attached to the tissue surface with no restriction to allow free movement, the handle 102 can be manipulated to reconfigure the substrate 100, for example, to retract the tissue site of interest. As shown in FIG. 9C, a vacuum force can be applied to the interior of the substrate 100' while holding the handle 102 in the reconfigured shape until the layers 101, 103 collapse against each other and against the contained beads 106. The beads 106 can collapse against each other to increase frictional resistance and force the substrate 100' to maintain the reconfigured shape and also force the attached tissue to maintain the same reconfigured shape, for example, to remain retracted. Once the vacuum force is removed and air is allowed to re-enter the interior of the substrate 100, the shape of the substrate 100 can relax and the attached tissue can flatten or return to its original shape.

[0043] 10A and 10B, various perspective views of the structure of an individual suction assembly 22 according to one embodiment are shown. 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 may be formed to have any number of cross-sectional shapes suitable for forming the suction chamber 112 (e.g., circular, elliptical, rectangular, polygonal, etc.) and may protrude distally from the lower housing 114 having a lower shoulder 116 that protrudes radially to form the lower outer periphery of the lower housing 114. The upper housing 118 may be attached to the lower housing 114 and may also have an upper shoulder 120 that protrudes radially to form the upper outer periphery of the upper housing 118. Between the lower shoulder 116 and the upper shoulder 120, a substrate attachment portion 122 may be formed for attachment to the first and second layers of the substrate. Additionally, the substrate attachment portion 122 may be provided at its outer periphery with one or more fluid channels 124 for fluid communication with the interior of the fixation layer 18. Although the lower housing 114 and the upper housing 118 are illustrated as having an annular configuration relative to the suction housing 110, the lower housing 114 and the upper housing 118 may be formed to have other shapes or configurations.

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

[0045] During use when a vacuum force is applied to the substrate, air or gas within the retaining layer 18 and within the housing chamber 134 may be evacuated by urging the valve 136 to an open configuration extending into the housing chamber 134 while being restricted from movement by the enlarged retaining portion of the retaining member 138. With the valve 136 thus open, air or gas within the suction chamber 112 may be evacuated through the floor 130, through the housing chamber 134, and through one or more openings exiting the one or more fluid channels 124, such that the suction housing 110 may be adhered to an underlying contact tissue surface by the negative pressure generated within the suction chamber 112. The valve 136 may be optionally biased in a closing direction against the floor 130 once the suction pressure reaches equilibrium between the housing chamber 134 and the suction chamber 112 (or the suction pressure falls below the biasing closing force of the valve 136), causing the valve 136 to close against the floor 130 to seal the suction chamber 112 from the housing chamber 134. In this manner, 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, which is particularly useful if vacuum pressure is lost within the fixation layer 18 during the procedure, as the individual suction assemblies 22 can maintain suction adhesion to the tissue surface independently of each other.

[0046] 12A and 12B, various perspective views of an alternative suction assembly 140 are shown illustrating a suction housing 142 that defines a suction chamber 144 that is in turn defined 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 to define a substrate mounting portion 154 around the periphery of the housing assembly. One or more fluid channels 156 may also be provided around the periphery of the substrate mounting portion 154.

[0047] As shown in the side cross-sectional view of FIG. 13, the manner in which the valve 166 is configured and positioned within the housing chamber 164 allows the height between the lower shoulder 148 and the upper shoulder 152 to be reduced relative to the previously described embodiments, while still providing fluid communication with the anchoring layer 18 through one or more fluid channels 156. The reduced height also allows the thickness of the substrate to be thinner relative to the substrate. In this case, the outer sealing surface 170 of the seal member 168 may be biased to remain closed against the opening 162 provided on the lower housing 160. The seal member 168 may be configured in a cone shape that protrudes from the valve body to urge the valve 166 to an open state when a vacuum is applied to the substrate. Negative pressure within the suction chamber allows the underlying tissue surface to adhere to the suction housing. As described above, once the suction pressure reaches equilibrium between the housing chamber 164 and the suction chamber 144 (or the suction pressure falls below 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. This allows the individual suction assemblies to adhere to the tissue surface.

[0048] As mentioned above, a vacuum tube attachment may be coupled to the substrate to provide fluid communication between the pump and the substrate and the stationary layer of the suction assembly. The vacuum tube attachment may be coupled anywhere on the substrate, but the attachment may also be coupled to one of the suction assemblies. FIG. 14 is a side cross-sectional view of 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 may be attached to the housing of the suction assembly, with the lumen 184 in direct fluid communication with the housing chamber 164. The proximal end of the tube 182 may be fluidly connected to a fluid line in communication with the pump, and upon activation of the pump, a vacuum force may be applied through the lumen 184 and the attached suction assembly. Because the suction assembly is fluidly coupled to the stationary layer and the other suction assembly, a vacuum force may be applied across the substrate and suction assembly as appropriate.

[0049] Turning now to other uses or embodiments of the positioning platform 10, any of the platform embodiments described herein may be used to facilitate various laparoscopic surgeries. In certain procedures, the platform may be used to establish a pneumoperitoneum in a patient by pneumoperitoneum in preparation for an abdominal (or other cavity) procedure. The practitioner typically identifies a location along the patient's body, such as the abdomen, to pierce an instrument, such as a Veress needle, through the skin until the tip reaches just inside the peritoneum. If the practitioner pierces the needle blindly, it may cause inadvertent trauma. For example, if a portion of the intestine is adhered to the inner wall of the peritoneum, piercing the needle through the adhesion may puncture or injure the intestine.

[0050] Once the needle is properly positioned within the patient, the cavity may be inflated through the needle and the primary trocar may be blindly inserted into the peritoneum. In patients with adhesions, the trocar may experience similar complications as needle insertion. Another instrument, such as a laparoscopic camera, may then be inserted through the primary trocar into the peritoneum to 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 may be used to facilitate separation of any intestinal tissue from within the abdominal wall by elevating the tissue site where the needle and / or trocar will be inserted. Elevating the tissue site also assists the practitioner in assessing whether adhesions are present prior to inserting the needle and / or trocar.

[0052] As an example, as shown in the side view of Figure 15, platform 10 is applied to skin surface S and the skin surface S is raised away from the patient to lift the adherent tissue and provide feedback regarding the presence of adhesions. Once an assessment has been made, needle 190 may be inserted through positioning guide 26 until needle piercing tip 192 or blunt tip 194 is inserted through the inner tissue wall avoiding adhesions. Alternatively, once assessment with platform 10 is complete, platform 10 may be removed from the tissue site and needle 190 may be inserted directly into and piercing skin surface S.

[0053] In other variations, the platform 10 may be utilized directly in combination with an imaging instrument, such as a laparoscope 200, as shown in side view in Figure 16. After inserting a trocar through the skin surface S, the trocar may be removed leaving the cannula sleeve 202 in place through the tissue site. The laparoscope 200 may be inserted directly through the cannula sleeve 202, for example, to view directly within the body cavity.

[0054] In yet another alternative, the platform 10 may be used in combination with imaging equipment such as an ultrasound transducer 212 in communication with the control 47 (as described above) or a separate ultrasound control 214, as shown in the perspective view of FIG. 17. The ultrasound transducer 212 may be used, for example, to determine whether adhesions are present below the skin surface prior to application of the platform 10 to a tissue surface. The ultrasound transducer 212 may be first applied to the skin and then removed to allow for use of the platform 10, although in other variations the ultrasound transducer 212 may be incorporated directly into the platform 10. In one embodiment, it is shown that one or more openings 210 may be formed through the platform 10 adjacent the positioning guide 26, and the ultrasound transducer 212 may be integral with the platform 10 in one of the openings 210. The transducer 212 may be used for real-time imaging of the tissue site beneath the platform 10 prior to and during trocar insertion while the platform 10 is directly adhered to the skin surface S.

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

[0056] The application of the disclosed invention as described above is not limited to a particular procedure or body part, but may include any number of other procedures and body parts. Modifications of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of ordinary skill in the art, are intended to be within the scope of this disclosure. Furthermore, various combinations of aspects between the embodiments are also contemplated and are considered to be within the scope of this disclosure as well.

Claims

1. a substrate having a first surface, a second surface opposite the first surface, and an interior formed between the first surface and the second surface; an instrument positioning guide protruding from the first surface of the substrate; one or more suction assemblies disposed along the second surface; Equipped with the second surface of the substrate is configured to be releasably adhered to a tissue surface by the one or more suction assemblies; An instrument positioning device, wherein each of the one or more suction assemblies is in fluid communication with an opening in the substrate through the interior of the substrate.

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

3. The apparatus of claim 2 , wherein the interior of the substrate comprises an anchoring layer disposed between the first surface and the second surface.

4. 4. The apparatus of claim 3, wherein the anchoring layer is configured to increase frictional resistance between an interior of the first surface and the second surface when the vacuum force is applied such that the predetermined configuration is maintained.

5. The device of claim 4 , wherein the retaining layer is comprised of a screen, mesh, beads, grooves, channels, or protrusions.

6. The device of claim 1 , wherein the substrate comprises a flexible substrate that is reconfigurable to conform to a tissue surface.

7. The apparatus of claim 1 , wherein the instrument positioning guide defines a receiving channel extending through the substrate.

8. The device of claim 7 further comprising a needle having a piercing tip.

9. The apparatus of claim 1 , wherein the instrument positioning guide is pivotable relative to the base.

10. The device of claim 1 , wherein the second surface comprises an adhesive for releasably adhering to the tissue surface.

11. The device of claim 1 , wherein the one or more suction assemblies each include a valve biased to maintain a closed configuration.

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

13. The device of claim 1 , further comprising an ultrasound transducer integral with the substrate and positioned proximate to the instrument positioning guide for sensing features within a tissue site.

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