Devices for delivering surgical patches during minimally invasive surgery

Abstract

A device for introducing and delivering a self-adhesive surgical patch during minimally invasive surgery is disclosed. The device includes a base that can be compressed to fit inside a tubular member having an inner diameter of 5 mm. In a preferred embodiment of the invention, the base comprises a frame made of a compliant material. The patch is attached to the frame when the frame is in a planar open configuration. Pressure is then applied to opposite sides of the frame compressing the frame into a linear closed configuration sufficiently small to pass through a tubular member having an inner diameter of 5 mm. After passing through the tubular member, the frame is reopened to its open configuration, enabling delivery and attachment of the patch to the target tissue. A kit for providing the device is also disclosed.

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 424,982, filed on November 14, 2022. Field of the Invention

[0003] The present invention generally relates to devices for use in minimally invasive surgery. More specifically, the present invention relates to a device for delivering a self - sealing surgical patch, such as a hemostatic patch, during minimally invasive surgery and a method for implementing the use of such a device. Background Art

[0004] Self - sealing surgical patches, such as hemostatic patches, are used to seal wounds during minimally invasive surgery, such as laparoscopic surgery, and produce a hemostatic effect by sealing tissue or organs. Many devices and methods have been developed for delivering self - sealing patches to the desired site.

[0005] U.S. Patent No. 5,397,332 discloses an applicator for a sheet of surgical material, such as a surgical patch. The applicator includes an expandable dilator tip that is normally accommodated in a delivery tube in a collapsed configuration. The elongate tube is introduced into the body. The delivery tube is retracted, and an actuator causes the dilator tip, which is then used to apply the surgical material, to expand. The dilator tip is made of stainless steel.

[0006] U.S. Patent No. 10,595,978 discloses a method for delivering a hemostatic patch to internal tissue during minimally invasive surgery. The patch is rolled up and placed inside a plastic bag. Then the plastic bag containing the patch is inserted into the body cavity via an elongate tube. The plastic bag is removed, and then the patch is unfolded and applied to the desired tissue.

[0007] U.S. Patent Application Publication No. 2003 / 0073979 discloses a device for delivering a patch. The device includes an umbrella - shaped or basket - shaped expandable assembly. The assembly is held inside the delivery tube in its retracted form. When the device is extended from the delivery tube, the device expands into its normal form, in which the device is used to deliver the patch attached thereto to the tissue. In some embodiments of the device, the device is self - expanding. The expansion element can be made of a wire composed of a material such as nitinol, stainless steel, platinum, or other materials having super - elastic properties.

[0008] U.S. Patent Application Publication No. 2009 / 0030435 discloses a device for anchoring a cardiovascular implant. In some embodiments of the present invention, the anchor is expandable upon deployment; it is held in a sleeve or tube in a compressed form and then expands after being removed from the tube. The anchor can be made of a "standard" material, such as stainless steel or nitinol.

[0009] U.S. Patent Application Publication No. 2014 / 0277579 discloses a construction for use in minimally invasive surgery. The construction includes an allograft patch having at least one layer of human amnion and chorion tissue and a collapsible rigid or semi-rigid frame. The patch is attached to the frame, which expands into its final shape after exiting a cannula through which the patch is inserted into the patient's body, such that the patch can be applied to tissue. Preferred shapes of the frame include a hemispherical shape, a plurality of spokes, and a cylinder.

[0010] International (PCT) Patent Application Publication No. WO2011128903 discloses an apparatus for delivering and positioning an expandable sheet in minimally invasive surgery. The apparatus includes a self-expanding assembly that may include a plurality of spokes that bend backward on a guide rod in a collapsed configuration. The expandable sheet is attached to an expandable end, and the apparatus is inserted into a tube. When the apparatus exits the tube, the assembly expands such that the expandable sheet can be delivered and positioned.

[0011] International (PCT) Patent Application Publication No. WO2015111040 discloses an apparatus for use in ophthalmic surgery, particularly for removing Descemet's membrane. The apparatus includes a semi-rigid circular frame that may be made of any material that will allow it to maintain its shape; plastics and metal alloys are given as examples. The frame passes through a tapered inserter head in a folded form; once the frame exits the inserter, it expands into its final circular shape; typical dimensions of 0.5 mm in thickness and 9 mm to 10 mm in diameter are given.

[0012] From the foregoing it is clear that while many devices and techniques for delivering surgical patches during minimally invasive surgery have been developed, the devices and methods known in the art tend to be complex and inconvenient for surgeons. Accordingly, there remains a long-standing but heretofore unmet need to develop improved devices and methods for delivering self-adhesive tissue patches, particularly hemostatic patches, in minimally invasive surgery. SUMMARY OF THE INVENTION

[0013] The present invention disclosed herein is directed to meeting this need. Devices and methods for introducing a self-adhesive tissue patch are disclosed, wherein the device and the patch may be introduced via a tubular member, such as a trocar, commonly used in minimally invasive surgery; after application of the patch, the device may be removed through the same tubular member; the patch is not prematurely activated; and the entire process of introducing the device and the patch, attaching the patch to the desired tissue and organ, and removing the device can be performed using only standard graspers used in minimally invasive surgery.

[0014] Accordingly, an object of the present invention is to disclose a device for introducing a self - adhering surgical patch during minimally invasive surgery, the device comprising a flexible base, wherein the base is flexible enough and comprises components of small enough size such that the base can be compressed to a small enough size to be inserted into a tubular member designed for use in minimally invasive surgery.

[0015] Another object of the present invention is to disclose such a device, wherein the base comprises a frame (100) which is generally in an open configuration of a generally planar size large enough to support the surgical patch, the frame being compressed to a linear closed configuration when pressure is applied in the plane, the linear closed configuration being small enough in size to be inserted into a tubular member designed for use in minimally invasive surgery, and the frame at least partially reopening towards the open configuration when the pressure is released. In some embodiments of the device, the linear closed configuration is small enough in size to be inserted into a tubular member characterized by an inner diameter between 5 mm and 12 mm. In some embodiments of the device, the linear closed configuration is small enough in size to be inserted into a tubular member characterized by an inner diameter of 5 mm. In some embodiments of the present invention, the tubular member is selected from the group consisting of cannulas, trocars, and tubes.

[0016] Another object of the present invention is to disclose an embodiment of the device in which the base comprises a frame, wherein the frame comprises: two flexible points or regions (130) opposite each other which, when pressure is applied substantially perpendicular to the line connecting the two flexible points or regions, collapse outwardly to form an acute angle; and corners (110) which are flexible enough to expand outwardly into a generally linear configuration when the pressure is applied.

[0017] Another object of the present invention is to disclose an embodiment of the device in which the base comprises a frame, wherein at least one of the following is true: two opposite points or regions of the frame are thinner relative to the rest of the frame, thereby providing flexibility to the frame; and two opposite points or regions of the frame are angled outwardly such that, under pressure applied in a direction substantially perpendicular to the line connecting the two opposite points or regions, the two opposite points or regions will tend to deform outwardly.

[0018] Another object of the present invention is to disclose a device as defined in any one of the above aspects, wherein the frame is adapted to attach the patch to the frame. In some embodiments of the present invention in which the frame is adapted to attach the patch to the frame, the frame includes a plurality of pins (140) extending out of the plane of the frame. In some embodiments of the present invention in which the frame is adapted to attach the patch to the frame, the frame includes a plurality of retaining members (360) pivotally attached to the frame, each of the retaining members including a leg and a head extending substantially horizontally from the leg.

[0019] Another object of the present invention is to disclose the following embodiment of the device: in this embodiment, the base includes a frame as defined in any one of the above aspects, wherein the frame includes at least one recess along its outer periphery.

[0020] Another object of the present invention is to disclose the following embodiment of the device: in this embodiment, the base includes a frame as defined in any one of the above aspects, wherein the frame includes at least one protrusion or handle (120) extending outwardly from the frame. In some preferred embodiments of the present invention, the protrusion or handle is substantially in the plane of the frame.

[0021] Another object of the present invention is to disclose an embodiment of a device as defined in any one of the above aspects, wherein the frame (100) includes: a lower portion (500); an upper portion (510) having a shape and dimensions substantially the same as the shape and dimensions of the lower portion; a hinge element (520) providing a hinge connection between the lower portion and the upper portion such that rotation about the hinge connection places the frame in a closed jaw configuration in which the lower portion is located above the upper portion and the upper portion and the lower portion substantially overlap each other; a mechanism for reversibly locking the lower portion and the upper portion together; tongues (560) located on two opposite sides of the upper portion; and grooves (550) located on two opposite sides of the lower portion, the grooves being sized to allow each tongue to be inserted into a matching groove, and the grooves being positioned such that each tongue engages a matching groove when the frame is in the closed jaw configuration.

[0022] In some preferred embodiments of the present invention in which the frame includes a lower portion and an upper portion, the mechanism for reversibly locking the lower portion and the upper portion together includes a plurality of pins (530) located on the lower portion and a plurality of holes (540) located on the upper portion, the holes being sized large enough to allow the pins to pass through the holes and positioned such that the pins engage the holes when the frame is in the closed jaw configuration. In some particularly preferred embodiments, each of the pins includes a lip or protrusion; the distance from the lower portion to the lip or protrusion is at least equal to the thickness of the upper portion; and the holes intersect with slots.

[0023] In some preferred embodiments of the present invention in which the frame includes a lower portion and an upper portion, the frame includes corners (110) that include notches.

[0024] Another object of the present invention is to disclose the following embodiment of the device: in this embodiment, the base includes a frame as defined in any one of the above aspects, wherein the frame includes a biocompatible plastic.

[0025] Another object of the present invention is to disclose the following embodiment of the device: in this embodiment, the base includes a frame as defined in any one of the above aspects, wherein the frame includes a biocompatible metal.

[0026] Another object of the present invention is to disclose the following embodiment of the device: in this embodiment, the base includes a frame as defined in any one of the above aspects, wherein the frame further includes at least one elongated member (490), the elongated member being attached to two opposite sides of the frame and bent out of the plane of the frame.

[0027] Accordingly, an object of the present invention is to disclose a device for introducing a self-adhesive surgical patch during minimally invasive surgery, the device including a flexible base (700) made of a biocompatible elastomer and a roller (710) attached to the flexible base, wherein the base is flexible enough to be compressed to a small enough size to be inserted into a tubular member designed for use in minimally invasive surgery. In a preferred embodiment of the present invention, the base is thin enough such that when the base is rolled into a generally cylindrical shape, the cylindrical shape has a cross-section characterized by a maximum transverse dimension not exceeding 5 mm.

[0028] Another object of the present invention is to disclose a device as defined in any one of the above aspects, wherein the device further comprises a bag (600) which can adopt a rolled-up configuration and an unfolded configuration and is configured to unfold to enclose the frame when the frame is in the closed configuration. In some preferred embodiments of the present invention, the bag is attached to the frame. In some preferred embodiments of the present invention in which the device comprises a bag, the device further encloses a flexible band (610) which is adapted to roll up or tear the bag when the bag is in the unfolded configuration. In some preferred embodiments of the present invention, the flexible band comprises a thread. In some preferred embodiments of the present invention, the flexible band comprises a strip made of a flexible biocompatible elastomer.

[0029] Another object of the present invention is to disclose a device as defined in any one of the above aspects, wherein the device is adapted to introduce a self-adhesive hemostatic patch during minimally invasive surgery.

[0030] Another object of the present invention is to disclose a device as defined in any one of the above aspects, wherein the frame comprises sides having a cross-sectional shape and size selected from the group consisting of: a substantially rectangular cross-section, characterized in that the length of the sides does not exceed 2.5 mm; a substantially circular cross-section, characterized in that the diameter does not exceed 2.5 mm; a substantially elliptical or oval cross-section, characterized in that the major axis does not exceed 2.5 mm; a substantially n-sided polygon cross-section (n≠4); and any combination of the above.

[0031] Another object of the present invention is to disclose a method for applying a self-adhesive surgical patch during minimally invasive surgery, wherein the method comprises:

[0032] If the device comprises a frame: (a) when the frame is in the open configuration, fixing the self-adhesive patch to the above-mentioned frame, thereby forming a patch / frame assembly; (b) applying pressure to at least two opposite sides of the patch / frame assembly, thereby converting the patch / frame assembly into the closed configuration;

[0033] If the device comprises a thin flexible base: (a) placing the self-adhesive patch on the surface of the base, thereby forming a patch / base assembly; (b) rolling the patch / base assembly into a sufficiently small tube shape to be able to be introduced into a tubular member designed for use in minimally invasive surgery;

[0034] (c) introducing the patch / frame assembly or the patch / base assembly via a tubular member; (d1) if the device includes a frame, reopening the patch / frame assembly into the open configuration; (d2) if the device includes a thin flexible base, deploying the patch / base assembly; (e) placing the patch on the target tissue or organ; and (f) separating the frame or base from the patch.

[0035] Another object of the present invention is to disclose a method wherein the step of placing the patch on the target tissue or organ is followed by a step of holding the patch / frame assembly in place until the self-adhesive patch has at least partially adhered to the target tissue or organ.

[0036] Another object is to disclose a method as defined in any of the above aspects, wherein the device includes an expandable bag, and the step (b) - applying pressure to at least two opposite sides of the patch / frame assembly, thereby converting the patch / frame assembly into the closed configuration, or rolling the patch / base assembly into a sufficiently small column to be introduced into a tubular member designed for use in minimally invasive surgery - is followed by a step of expanding the expandable bag so as to enclose the patch / frame assembly or the patch / base assembly; and the step of introducing the patch / frame assembly or the patch / base assembly is followed by a step of rerolling or tearing the bag thereby exposing the patch / frame assembly or the patch / base assembly.

[0037] Another object of the present invention is to disclose a method as defined in any of the above aspects, wherein the self-adhesive surgical patch is a self-adhesive hemostatic patch.

[0038] Another object of the present invention is to disclose a method as defined in any of the above aspects, wherein the step of placing the patch on the target tissue or organ is followed by a step of holding the patch / frame assembly in place until the self-adhesive patch has at least partially adhered to the target tissue or organ.

[0039] Another object of the present invention is to disclose a device as defined in any of the above aspects for use in a method as defined in any of the above aspects. Another object of the present invention is to disclose the use of a device as defined in any of the above aspects in a method as defined in any of the above aspects.

[0040] Another object of the present invention is to disclose a kit for supplying a device for introducing a self - adhering surgical patch during minimally invasive surgery, the kit comprising: a device as defined in any of the above aspects; a protective sleeve (800) sized to enclose the frame when the frame is in a closed configuration; a line (810) attached to the protective sleeve; a suture retainer (820) configured to hold the line before using the device; an auxiliary tube (830) configured to assist in rolling up the protective sleeve; and a tray (840) configured to hold the device, the protective sleeve, the line, the suture retainer, and the auxiliary tube. In some preferred embodiments of the kit, the kit further comprises a medical - grade breathable paper extending over the tray, thereby sealing the kit. In some particularly preferred embodiments of the kit, the kit includes a device that includes a frame, the frame including a lower portion (500) and an upper portion (510) as defined in any of the above aspects. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The present invention will now be described with reference to the drawings, in which:

[0042] Figure 1 a schematic diagram including several views showing a non - limiting embodiment of a frame for delivering a surgical patch according to the present invention disclosed herein;

[0043] Figure 2A and Figure 2B schematically illustrates the conversion of a frame of an embodiment disclosed herein between an open (planar) configuration and a closed (linear) configuration;

[0044] Figure 3 a schematic diagram including several views showing another non - limiting embodiment of a frame for delivering a surgical patch according to the present invention disclosed herein;

[0045] Figure 4A and Figure 4B schematically illustrates a non - limiting embodiment of a frame for delivering a patch, wherein the frame includes a pivotable retainer for fixing the patch to the frame, and the retainer is positioned to respectively allow placing the patch on the frame and grasping the patch;

[0046] Figure 5A and Figure 5B respectively schematically illustrate a top view and a side view of an embodiment of a frame for delivering a surgical patch according to the present invention disclosed herein, wherein the frame includes elements designed to apply pressure to the surgical patch when the patch is applied to tissue;

[0047] Figures 6A to 6F Schematically illustrates several views of another embodiment of a frame for delivering a surgical patch according to the present invention disclosed herein, wherein the frame has a jaw-like configuration;

[0048] Figure 7 Schematically illustrates a non-limiting embodiment of the present invention, which includes: an expandable bag that can be unfolded to enclose the frame when the frame is in its linear configuration; and a flexible band for removing or tearing the bag after the frame assembly exits the tubular member, wherein the frame assembly is introduced through the tubular member;

[0049] Figures 8A to 8H Illustrates Figure 7 The usage of the bag enclosing and introducing the patch / frame assembly of the present invention disclosed herein as schematically shown in;

[0050] Figures 9A to 9D Schematically illustrates several views of a non-limiting embodiment of the present invention, wherein the patch is seated on a flexible base, and the flexible base is rolled into a column before the patch is introduced into the patient's body; and,

[0051] Figure 10A And Figure 10B Schematically illustrate the exploded view and the telescoped view of a kit that includes components for delivering a surgical patch during minimally invasive surgery; and,

[0052] Figures 11A to 11H Schematically illustrates the usage of the kit shown in FIG. 10 to pass a hemostatic patch through a trocar with an inner diameter of 5 mm.

[0053] It is emphasized that the drawings are presented for illustrative purposes only to assist those of ordinary skill in the art in making and using the invention disclosed herein. Unless otherwise clearly described in the specification, the specific shapes, specific dimensions, or specific relative shapes or dimensions schematically illustrated in the drawings should not be considered limiting in any way. Detailed Description

[0054] In the following description, various aspects of the present invention will be described. For the purpose of explanation, specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent to those skilled in the art that there are other embodiments of the present invention that are different in detail without affecting its basic properties. Therefore, the present invention is not limited by the contents illustrated in the accompanying drawings and described in the specification, but is only limited by the contents indicated in the attached claims, wherein the appropriate scope is determined only by the broadest reasonable interpretation of the claims. In some cases, for clarity or simplicity, the various elements of the present invention are discussed separately. Nevertheless, the inventors believe that any non-contradictory combination of the various elements of the present invention disclosed herein is within the scope of the present invention.

[0055] In all cases where an embodiment is described as “comprising” a set of components or method steps, i.e., the invention may include components or method steps in addition to those components or method steps explicitly listed, the scope of the invention should be understood to include embodiments of the invention “consisting of the listed components or method steps,” i.e., embodiments that include the listed components or method steps but not other components or method steps, and also include embodiments of the invention “consisting essentially of the listed components or method steps,” i.e., embodiments that do not include any unlisted components or method steps that would materially affect the basic and novel characteristics of the invention.

[0056] Unless otherwise specifically stated, any numerical range disclosed herein should be understood to include any sub-range within its scope. As a non-limiting example, if a range is stated as "1% to 10%", the inventors believe that ranges of 1% to 5%, 2% to 9%, etc. are within the scope of the present invention; similarly, if a range is stated as "less than 50%", it is believed that ranges of less than 40%, less than 25%, less than 10%, etc. are within the scope of the present invention.

[0057] As used herein, with respect to numerical quantities, the expression "about" refers to a deviation of about ±25% of the nominal value.

[0058] In the description and illustrations of the various embodiments of the present invention disclosed herein, like reference numerals refer to like parts of the present invention.

[0059] As used herein, with respect to surgical patches, the term "self-adhesive" refers to patches that adhere to tissue or organs without the need for the addition of any substance that attaches or adheres the patch to the tissue or organ, and without the need for any means of attachment external to the patch, such as suturing or stapling. Unless otherwise specified, patches that have adhesive affixed or incorporated as part of the manufacturing process and patches that have adhesive applied at any time after manufacturing and prior to attachment to the target tissue or organ are within the scope of this definition.

[0060] As used herein, the term "tubular member" refers to an elongated structure having at least one passageway that extends completely therethrough along the longitudinal axis of the structure. Non-limiting examples of tubular members include trocars, cannulas, and tubes.

[0061] As used herein, the term "polygon" is used to describe a shape having at least three generally straight sides that together form a closed, generally planar structure. Non-limiting examples of structures that are considered "polygons" within the scope of the term as used herein include: closed figures having straight sides and vertices; structures having rounded corners; structures having rounded sides; structures having curved sides; and structures having sides with notches or indentations.

[0062] For simplicity and clarity of presentation, the term "device" is generally used to describe the inventions disclosed herein. The use of this term should not be construed as an assertion, admission, or concession as to whether any embodiment of the inventions disclosed herein will be considered a "device" or an "accessory" as these terms are defined by the U.S. Food and Drug Administration and no such assertion, admission, or concession should be inferred from the use of the term "device" in any description of the inventions herein. The use of the term "device" should also not be understood to necessarily exclude "accessories" from the scope of any claim.

[0063] The present invention discloses novel devices and methods for introducing self-adhesive surgical patches, such as hemostatic patches, during minimally invasive surgery, wherein the patch is reversibly attached to a base, the size of which can be reduced to fit within a tubular member designed for use in minimally invasive surgery. In exemplary non-limiting embodiments of the present invention, the size of the base can be reduced to fit within a tubular member having an inner diameter of 5 mm to 12 mm. In a preferred embodiment of the present invention, the size of the base can be reduced to fit within a tubular member having an inner diameter of 5 mm, such as a trocar having an inner diameter of 5 mm. After introducing the patch / base assembly through the tubular member (e.g., trocar), the assembly is restored to its original size, the patch is applied to the target tissue or organ, and the base is removed. In some embodiments of the present invention, the base is a frame made of a compliant material to which at least two of the edges of the patch are attached, while in other embodiments, the base is a thin flexible support member sized at least as large as the patch on which the patch sits prior to its deployment. In some embodiments of the present invention, the present invention is applicable to introducing hemostatic patches. In some preferred embodiments of the present invention, the present invention is applicable to introducing hemostatic patches that attach the patch to the target organ or tissue using a thrombin / fibrinogen sealant. In some particularly preferred embodiments of the present invention, the present invention is applicable to introducing hemostatic patches of the type disclosed in U.S. Patent Nos. 10,905,792, 11,071,805, 11,471,556, and 11,771,799.

[0064] In some preferred embodiments of the present invention disclosed herein, the device for delivering a surgical patch includes a frame (100) made of a compliant material. That is, the material constituting the frame allows the frame to be compressed when a force is applied thereto and to at least partially return to its original configuration when the force is released. The surgical patch is attached to the frame and delivered therefrom, as described in detail below. The frame can be made of any of the following biocompatible compliant materials: the biocompatible compliant material is rigid enough to support the patch but flexible enough to be able to open and close as described below. Non-limiting examples of suitable materials include biocompatible plastics such as medical grade PVC, polyethylene, PET, polypropylene, polycarbonate, PEEK, polysulfone, and polyurethane, and biocompatible metals such as stainless steel and nitinol.

[0065] Now referring to Figure 1, which presents a schematic diagram showing several views of a non - limiting embodiment 1000 of a device for delivering a surgical patch disclosed herein. In the illustrated embodiment, the frame (100) is generally square, wherein the length of the sides is about 50 mm. In a typical embodiment, the sides of the frame have a generally rectangular, preferably square, cross - sectional shape. The inventors believe that other shapes are within the scope of the present invention, non - limiting examples of which include cross - sectional shapes with rounded corners, cross - sectional shapes with rounded or curved sides, generally circular shapes such as circles and ellipses, and generally polygonal shapes with n sides (n≠4). In embodiments where the sides of the frame are generally rectangular, the width and depth of the frame (i.e., the lengths of the sides of the rectangular cross - section) are typically from 2 mm to 2.5 mm. The corners of the frame (110) are flexible enough such that when pressure is applied to two opposite sides of the frame, two diagonally opposite corners open sufficiently, and the other two corners close sufficiently, and the frame is converted from the polygonal, generally planar "open" configuration shown in the figure to a "closed" configuration in which the frame adopts a generally linear structure.

[0066] Thus, the frame can be inserted into a tubular member, such as a trocar designed for use in minimally invasive surgery, when in its closed configuration. In those preferred embodiments where the sides of the frame are characterized by dimensions of width and depth (e.g., the length of the sides of the frame or its maximum cross - sectional diameter) not greater than 2.5 mm, the frame in its closed configuration will thus have a transverse dimension of no more than 5 mm and can therefore be inserted into a tubular member with an inner diameter of 5 mm, such as a trocar, in its closed configuration. Although in these preferred embodiments the frame can be inserted into a trocar characterized by an inner diameter of 5 mm in its closed configuration, the inventors believe that frames suitable for insertion into tubular members of other inner diameters, non - limiting examples of which include standard trocars characterized by inner diameters from 5 mm to 12 mm, such as a trocar with an inner diameter of 6 mm, a trocar with an inner diameter of 10 mm, and a trocar with an inner diameter of 12 mm, are within the scope of the present invention. In Figure 1 the illustrated embodiment, to make it easier for a surgeon to grasp and pinch the frame using a standard gripper used in minimally invasive surgery, the frame includes at least one protrusion or handle 120 extending outward from the frame. In a preferred embodiment of the present invention, the protrusion or handle is substantially in the plane of the frame, but the inventors believe that configurations where the protrusion is not coplanar with the frame are within the scope of the present invention.

[0067] The frame can be manufactured by any method known in the art for producing structures of the desired size and shape from a selected material. Non - limiting examples include injection molding, 3D printing, and extrusion.

[0068] Figure 1The illustrated embodiment of the frame includes a plurality of pins 140 extending from one side of the frame. These pins are used to fix the surgical patch to the frame. The patch is stretched over the frame and pulled over the pins such that the pins penetrate into or pierce the patch, thereby holding the patch to the side of the frame while leaving the center of the patch undisturbed. In the illustrated embodiment, the frame includes a total of six pins, three pins on each of two opposite sides. In this embodiment, the pins are characterized by a height and depth of approximately 2 mm to 2.5 mm. As shown in the figure, in a typical embodiment of the present invention, the pins are preferably not cylindrical, but include an extension or lip at the top to better grip the patch when placing the patch on the frame. It should be emphasized that the number of pins and the exact dimensions and shapes should not be considered limited by the drawings; in embodiments where the patch is fixed to the frame by using pins, any convenient number of the following pins can be used: the pins are large enough to be able to fix the patch to the frame and small enough to allow the frame to fit into a tubular member designed for use in minimally invasive surgery in the closed configuration of the frame, as well as any convenient shape for attaching the patch.

[0069] Now refer to Figure 2A and Figure 2B , which schematically illustrate typical non - limiting embodiments of the frame transitioning between an open configuration and a closed configuration. In the non - limiting embodiment illustrated in the figure, the frame includes two flexible points or regions 130 located on opposite sides. Flexibility can be provided by setting notches at these two points in the frame as illustrated in Figure 2A ; the two flexible points are indicated by circles. In some preferred embodiments of the present invention, the frame is slightly angled outward at these points such that they will tend to collapse outward rather than inward. As schematically illustrated in Figure 2A , by applying pressure to two opposite sides of the frame that do not include the flexible points as indicated by the arrows, the frame transitions from its planar open configuration to its closed linear configuration. As shown in Figure 2B , when pressure is applied in this way, the two flexible points or regions collapse outward as indicated by the solid circles to form an acute angle - an angle approaching zero degrees in the limit state of full collapse, while the corners of the frame expand into a substantially linear configuration, where the change of two adjacent corners is indicated by the dashed circles. When the pressure is released, the frame made of a compliant material at least partially returns to its substantially polygonal open structure. The inventors believe that the following embodiments are within the scope of the present invention: in this embodiment, when the pressure is released, the frame only partially re - opens, and is fully restored to its open configuration by grasping the partially opened frame and pulling the frame outward, thereby returning the frame to its fully open configuration.

[0070] Now refer to Figure 3, which presents a schematic diagram showing several views of another non - limiting embodiment 2000 of the present invention. Figure 3 The frame shown in Figure 1 is substantially similar to the frame shown in FIG. 2, except that there is no concave recess in the outer peripheral edge of one side of the frame, but rather two opposite sides of the frame have projections 120 extending outward from the frame. In a preferred embodiment, the projections 120 are substantially in the plane of the frame.

[0071] Now referring to FIG. 4, which illustrates a third non - limiting embodiment 3000 of the present invention, the third non - limiting embodiment includes an alternative mechanism for attaching a patch to a frame. In this embodiment, a plurality of pivotally attached retainers 360 are attached to the outer peripheral edge of the frame. A typical non - limiting embodiment is illustrated in Figure 4A . In the illustrated embodiment, a plurality (four in the illustrated embodiment) of retainers are pivotally attached to the outer peripheral edge of the frame. The pivot direction of the retainers is illustrated by arrows 370 in the figure. The retainers include legs and heads that extend generally horizontally from the heads. In a preferred embodiment of the present invention, the heads have recesses such that the heads can grip or attach to the frame as the legs rotate about the pivot points on the frame. Figure 4B illustrates the configuration in which the retainers have pivoted to hold the patch 180 to the frame. When the surgeon wishes to deploy the patch, the retainers rotate back to their position where they do not grip the patch, and the patch is removed from the frame. This embodiment of the device for attaching the patch has the advantage that the patch can be attached to and removed from the frame without piercing the patch.

[0072] Many self - adhesive surgical patches, especially those in which the adhesive is activated by contact with body fluids, require pressure to be applied within a short time after they are delivered to ensure that they will fully adhere to the tissue or organ to which they are delivered. Now referring to FIG. 5, which provides a schematic diagram of a non - limiting embodiment 4000 of the frame of the present invention disclosed herein, wherein the frame includes an element that provides such pressure. Figure 5A shows a top view of a typical configuration. The frame includes flexible elongate elements 490 attached to two opposite sides of the frame. In the embodiment illustrated in the figure, the element is generally bent in an "S" shape along its length. This type of shape is preferred because it maximizes contact with the patch, but this type of shape should not be considered limiting in any way; the element can take any convenient shape that allows the frame to be converted into a linear closed configuration, and the frame in the linear closed configuration will fit into a tubular member, such as a trocar with an inner diameter of 5 mm, designed for use in minimally invasive surgery. In Figure 5BFigure 1 schematically shows a side view of a frame according to this embodiment. As can be seen from the figure, the elongated element is not in the plane of the frame, but extends outside the plane in an arcuate configuration. When the system is assembled, the patch is placed on the following side of the frame, preferably placed tightly enough on the following side of the frame: the elongated element rises outside the plane of the frame on this side, such that the elongated element is at least partially deformed in the direction of the plane of the frame. When delivering the patch, the elongated element will exert pressure on the patch, while the frame remains in place at the position where the patch is delivered. Once the adhesive of the patch is sufficiently activated to adhere to the tissue to which it is applied, the frame can be removed.

[0073] The insertion and application of the patch can be performed as follows. As described above, the patch is attached to the frame, wherein the adhesive side of the patch faces upward, i.e., the adhesive side of the patch does not directly physically contact the frame, thereby forming a patch / frame assembly. This step can be performed in a sterile environment, such as a clean room, and the patch / frame assembly is placed in a sterile package for use in surgery, or it can be assembled in the operating room before the assembly is used in a minimally invasive surgery. Then the assembly is collapsed to the closed linear configuration of the frame, and the assembly is introduced into the patient's body via a tubular member (e.g., a trocar with an inner diameter of 5 mm) designed for use in minimally invasive surgery. After the assembly has been inserted, the release of pressure on the side of the frame will cause the frame to at least partially reopen towards its open configuration. In some embodiments of the present invention, the frame is made of a material that does not automatically fully return to the open configuration. In these embodiments, the frame is reopened by using a pair of grippers. Then the patch / frame assembly is maneuvered to the application site and placed on the tissue or organ to which the patch is to be applied, wherein the patch side of the assembly contacts the tissue or organ. In a preferred embodiment of the present invention, the adhesive is activated at this time, for example, by reacting with body fluid on the surface of the tissue or body fluid exuded from the tissue. Once the patch is sufficiently adhered to the tissue, the frame is separated, leaving the patch behind. The frame is recompressed to its linear configuration and removed via a tubular member (usually but not necessarily the tubular member through which the patch was introduced) designed for use in minimally invasive surgery.

[0074] Now referring to Figure 6, which presents several views of an additional embodiment 5000 of the frame of the present invention disclosed herein, wherein the frame has a jaw-like configuration, wherein the frame includes two parts that are in an open jaw configuration before the patch is placed, and after the patch is placed on the frame, the two parts are closed one on top of the other to be in a closed jaw configuration that holds the patch. Now referring to Figure 6A, which schematically illustrates a preferred embodiment of the present invention. The frame (100) includes two parts of substantially the same shape and size, namely a lower part 500 and an upper part 510. In a typical non-limiting embodiment of the present invention, the lower part 500 and the upper part 510 are each substantially rectangular and have dimensions of approximately 5 cm × 7 cm when the frame is in its open configuration (i.e., before it is compressed into a closed configuration for insertion into a tubular member). The lower part 500 and the upper part 510 are connected in a hinged manner by a hinging element 520, which allows the upper part and the lower part to rotate relative to each other about an axis passing through the connecting member while substantially maintaining their positions relative to a plane perpendicular to the axis. The hinging element 520 does not have to be an actual hinge, but can be any flexible structure that allows relative movement of the two parts of the frame. As a non-limiting example, in the embodiment schematically illustrated in Figure 6A , the hinging element includes a flexible plastic piece that connects the two parts of the frame. In a preferred embodiment of the present invention, the lower part 500 includes a protrusion or handle 120 that is substantially coplanar with the lower part 500 on a side opposite to the side connected to the hinging element. In a preferred embodiment of the present invention, the hinging element includes a groove such that when the upper part and the lower part of the frame engage each other, the hinging element forms a second protrusion or handle. Such an embodiment is schematically illustrated in Figure 6A .

[0075] In a preferred embodiment, the frame includes a mechanism for reversibly locking the upper part and the lower part together once the upper part and the lower part are brought together after rotating about the hinging element. Figure 6A illustrates a non-limiting example of a reversible locking mechanism. The lower part of the frame includes a plurality of pins 530 arranged around the perimeter of the frame. It is emphasized that, contrary to the embodiments of the present invention, such as those illustrated in Figure 1 and Figure 3 , the pins 530 do not engage a patch. On a side of the lower part of the frame adjacent to the side connected to the hinging element, the pins are spaced apart by a distance longer than one dimension of the patch such that the patch can sit on the lower part of the frame without being pierced by the pins 530 or otherwise engaging the pins 530. The upper part of the frame includes a plurality of holes 540 having dimensions and spacings such that the holes can engage the pins such that when the pins engage the holes, the two parts of the frame sit one on top of the other, wherein the perimeters of the two parts substantially overlap each other. Enlarged views of the holes and the pins are illustrated in Figure 6B and Figure 6C respectively. In the manner as Figure 6CIn the preferred embodiment of the invention illustrated herein, the pin is not cylindrical but includes a lip or protrusion. In a preferred embodiment of the invention, the hole 540 passes completely through the upper portion of the frame and intersects the slot 545. The slot 545 provides sufficient flexibility in the area around the hole 540 such that the pin can pass through the hole 540 without damaging the upper portion of the frame. In an embodiment, such as the embodiment depicted in FIG. 6, the reversible locking mechanism operates by passing the pin through a matching hole until the lip at the top of the pin is exposed and engages the upper portion of the frame. Now refer to Figure 6D , which shows an enlarged view of the pin and hole when the frame is in its closed and locked configuration.

[0076] In a preferred embodiment of the jaw-like embodiment (5000) of the invention, the corners 110 of the upper and lower portions of the frame include notches to increase their flexibility and thereby enable the user to more easily compress the frame to a size that will fit into a tubular member designed for use in minimally invasive surgery, preferably a trocar having an inner diameter of 5 mm. In Figure 6B and Figure 6C , enlarged views of the corners according to this embodiment are schematically illustrated.

[0077] To hold the patch in place, the lower portion of the frame includes grooves 550 located on opposite sides of the frame, preferably on the sides adjacent to the sides to which the hinge elements are attached. In a preferred embodiment of the invention, the length of the groove is at least equal to one dimension of the patch to be applied. The upper portion of the frame includes tongues 560 located on opposite sides of the frame, the tongues 560 being no longer than the grooves and positioned such that the tongues will engage the grooves when the two portions of the frame contact each other by rotating about the hinge elements.

[0078] Now refer to Figure 6E , which provides a detailed cross-sectional schematic view of the dovetail system for holding the patch in the frame. The left side of the figure shows a view along cross-section A-A of the upper portion of the frame, and the right side of the figure shows a view along cross-section B-B of the lower portion of the frame. As can be seen in the figure, in a preferred embodiment, the depth and width of the groove are at least equal to the height and width of the tongue. In the embodiment shown in Figure 6D , the tongues and grooves have a generally cylindrical or semi-cylindrical shape, but this particular shape should not be considered limiting; the inventors believe that any of the following shapes of the grooves and tongues are within the scope of the invention: the shapes of the grooves and tongues such that they can engage each other, hold the patch in place, and separate from each other when sufficient force is applied.

[0079] To hold the patch in place, the patch is placed on the lower part of the frame such that the patch sits on two grooves. Then, the upper part rotates about an axis defined by a hinge connection and thereby engages the lower part, bringing the frame into a closed jaw configuration. The two parts of the frame are locked together by a locking mechanism (such as the pins and matching holes described above), while the patch is held in place by the engagement of a tongue and groove. Now referring to Figure 6F , the patch is held between the two parts of the frame. In the embodiment illustrated in the figure, the hinge element is designed such that when the frame is in its closed configuration, the hinge element forms a second protrusion 120.

[0080] To simplify the operation of introducing the patch / frame assembly into a patient's body during surgery, some preferred embodiments of the present invention include an expandable pouch into which the patch / frame assembly can be inserted prior to its introduction. Now referring to Figure 7 , which illustrates a non-limiting embodiment 6000 of the present invention, wherein the embodiment includes such a pouch (600). In the embodiment illustrated in the figure, the pouch is physically attached to the frame, but the inventors contemplate that embodiments in which the pouch is an independent component of the system are within the scope of the present invention. The pouch can be made of any biocompatible elastomer capable of being rolled into a substantially flat configuration and then unfolded to enclose the frame. Non-limiting examples of such elastomers include silicone, polyurethane, polyisoprene, and latex. The patch / frame assembly is compressed to its closed linear configuration, the pouch is unfolded to enclose the assembly, and then the pouch is inserted through a tubular member. Now referring to Figures 8A to 8H , which illustrates the sequential steps of the process of enclosing and introducing the patch / frame assembly by using the pouch schematically shown in Figure 7 .

[0081] In some preferred embodiments of the present invention in which the system includes an expandable pouch, a flexible band 610 is also provided that is designed to tear or unfold the pouch. Such a band is schematically illustrated in Figure 7 . Like the pouch, the band can be attached to the frame or included as a separate component. Non-limiting examples of the design of the flexible band include threads and strips made of a biocompatible material such as polyethylene. After the assembly has been introduced into the patient's body, the flexible band is used to tear (in the case where the band is in the form of a thread) or re-roll (in the case where the band is in the form of a strip) the pouch, and once the patch has been deployed, the pouch can then be removed together with the frame. In some preferred embodiments of the present invention in which the flexible band includes a thread, the pouch includes a weakened portion along its length to make it easier to tear the pouch. As a non-limiting example, the pouch can be scored along its length.

[0082] The following embodiments of the present invention are also disclosed within the scope of the present invention: In this embodiment, the base is a thin, flexible, solid base on which the patch sits, rather than an open frame with a patch attached at its edges as described above. The base can be made of any of the following biocompatible materials: When the patch sits on the base, the biocompatible material is rigid enough to serve as a stable base for the patch, but the biocompatible material is flexible enough that the base can be rolled into a column with a small enough outer diameter to fit inside a tubular member designed for use in minimally invasive surgery. Non-limiting examples of materials from which the base can be made include biocompatible plastics and elastomers.

[0083] Now refer to Figures 9A to 9D , which illustrates a non-limiting embodiment 7000 of the present invention, wherein the frame includes a thin, solid base 700. As Figure 9A illustrated in, roller 710 is disposed on the base at one side. In a preferred embodiment of the present invention, the base includes a recess 720 in which the roller sits. In a preferred embodiment of the present invention, the roller includes a head 730 with a diameter less than 5 mm; an enlarged view of the head is shown in Figure 9B . The roller can be attached to the patch, for example, via a protrusion or a clip. The patch is placed on the base with the adhesive side up, and then the patch is rolled around the roller to form a column with a small enough outer diameter to fit into a tubular member (such as a trocar with an inner diameter of 5 mm) designed for use in minimally invasive surgery, as Figure 9C shown in. In some preferred embodiments of the present invention, the base includes Figure 7 and a bag of the type illustrated in FIG. 8 that extends over the rolled-up patch, thereby enclosing the patch for introduction into the patient's body, as Figure 9D shown in. As described above, the assembly is introduced via a tubular member, such as a trocar. After the assembly is introduced, the bag (if used) is removed, the roller is used to unroll the assembly, and the patch is deployed on the target tissue or organ, where, in a preferred embodiment of the present invention, the adhesive is activated as described above.

[0084] The inventors emphasize that although the drawings illustrate embodiments of the present invention in which the frame and the patch are generally rectangular, the drawings are presented only to enable one of ordinary skill in the art to make and use the present invention disclosed herein and should not be considered to limit in any way the size or dimensions of the base or the patch. The patch can have any convenient shape, and the frame can have any shape suitable for delivering the patch and any suitable size that can be compressed to fit inside a tubular member designed for use in minimally invasive surgery, preferably a tubular member characterized by an inner diameter of 5 mm.

[0085] Also within the scope of the present invention is disclosed a kit for providing a device for introducing a self - adhesive surgical patch during minimally invasive surgery according to the present invention, and components that can be used to assemble the device prior to use of the device.

[0086] Reference is now made to Figure 10A , which presents a schematic exploded view of a non - limiting embodiment (8000) of the kit disclosed herein. The kit includes a frame (100); in the embodiment of the kit illustrated in FIG. 10, the kit includes the embodiment (5000) of the frame illustrated in FIG. 6. The kit also includes a protective sheath 800 for protecting the hemostatic patch from harmful environmental influences, such as exposure to fluids. In some non - limiting preferred embodiments of the present invention, the protective sheath is made of polyurethane. A wire or fiber 810 is attached to one end of the protective sheath; the wire or fiber is used to remove the protective sheath from the patient's body once the patch has been introduced. In some non - limiting preferred embodiments of the present invention, the wire or fiber is made of polyester. The kit also includes a suture retainer 820 for holding the wire within the package. The suture retainer does not contact the patient's body; in some non - limiting preferred embodiments of the present invention, the suture retainer is made of polyethylene terephthalate glycol (PETG). The kit also includes an auxiliary tube 830 for assisting in the rolling up of the protective sheath 800. In some non - limiting preferred embodiments of the present invention, the auxiliary tube is made of polyether block amide, which can be commercially available under trade names such as PEBAX and VESTAMID E. In the Figure 10A exploded view illustrated in, the auxiliary tube is shown separated from the protective sheath, but in the preferred embodiment of the present invention, the kit is provided with an auxiliary tube inserted into the protective sheath. Finally, the kit includes a tray 840, which includes notches sized and shaped to allow the other components of the kit to rest securely within the notches. These notches can be produced by any technique known in the art, such as by molding. The tray does not contact the patient's body. In the preferred embodiment of the present invention, the tray is made of PETG, but can also be made of any suitable material. In some embodiments, the kit includes a lid ( Figure 10A the lid is not illustrated in) that slides fit onto the tray. In a preferred non - limiting embodiment, the lid is made of PETG.

[0087] Reference is now made to Figure 10B, which schematically illustrates an embodiment of the kit inside the tray 840 when the kit is provided to the user. Once the components of the kit have been placed in the tray, the tray is sealed with a medical-grade breathable paper, preferably a paper made of non-woven HDPE fibers, such as the paper sold under the trade name TYVEK 1073B. The paper is designed to be peeled off the tray immediately before using the components of the kit. In a preferred embodiment of the present invention, the kit is sterilized before being supplied to the user, preferably sterilized to a sterility assurance level of 10 -6 by gamma radiation in accordance with ISO 11137-2:2013, optionally in combination with ISO 13004:2022.

[0088] Now referring to FIG. 11, which illustrates the use of the kit shown in FIG. 10 to introduce a hemostatic patch into a trocar having an inner diameter of 5 mm. The illustration in FIG. 11 is intended to assist a person of ordinary skill in the art in making and using the invention disclosed herein and is not intended to be limiting in any way. Figure 11A Illustrates an embodiment of the kit when the kit appears after removal of the seal, wherein the components of the kit are located inside matching recesses in the tray. In the embodiment illustrated in FIG. 11, the frame of the embodiment (5000) shown in FIG. 6 is used. The hemostatic patch (e.g., by using dry forceps) is placed on the lower part of the frame, and then the frame is closed to its closed jaw configuration and locked, thereby holding the patch in place, as Figure 11B illustrated. The frame is then collapsed to its closed configuration by pulling on the protrusion 120, thereby rolling up the patch, with the side that will engage the patient's tissue located on the inner side of the roll. The frame is then inserted into the protective sleeve 800 by using the auxiliary tube 830 ( Figure 11C ). Once the frame with the wound membrane is placed in the protective sleeve, the auxiliary tube is removed and discarded, as Figure 11D illustrated. As Figure 11E shown, the frame (still inside the protective sleeve) is then inserted into the tubular member; in the illustrated embodiment, the protective sleeve and the frame are inserted into a standard trocar having an inner diameter of 5 mm. Then, the frame still inside the protective sleeve is pushed through the trocar by using any suitable device known in the art, such as an endoscope or a grasper ( Figure 11F ). Once the frame is in place, the protective sleeve is removed by pulling on the wire or fiber 810, as Figure 11G illustrated. Once the protective sleeve is removed, the frame opens towards its open configuration, wherein the patch remains in place and is ready to be applied to the desired tissue, as Figure 11HAs illustrated. Once the patch is placed on the tissue and left in place long enough to effect hemostasis, the frame is separated from the patch using any suitable tool, such as a laparoscopic grasper, folded back to its closed configuration, removed from the body through the tubular member, and discarded.

Claims

1. A device for introducing a self - adhering surgical patch during minimally invasive surgery, the device comprising a flexible base, wherein, The base is flexible enough and includes members of a small enough size such that the base can be compressed to a small enough size to be insertable into a tubular member designed for use in minimally invasive surgery.

2. The device according to claim 1, wherein, The base includes a frame (100) that is generally in an open configuration of a size large enough to support the surgical patch in a generally planar shape, the frame (100) being compressible to a linear closed configuration of a size small enough to be insertable into a tubular member designed for use in minimally invasive surgery when pressure is applied in the plane, and the frame reopening at least partially towards the open configuration when the pressure is released.

3. The device according to claim 2, wherein, The frame includes sides having a cross-sectional shape and size selected from the group consisting of: A generally rectangular cross-section, characterized in that the length of the sides does not exceed 2.5 mm; A generally circular cross-section, characterized in that the diameter does not exceed 2.5 mm; A generally elliptical or oval cross-section, characterized in that the major axis does not exceed 2.5 mm; A generally n-sided polygonal cross-section (n≠4); and Any combination of the above.

4. The device according to claim 1, wherein The size of the linear closed configuration is small enough to be insertable into a tubular member characterized by an inner diameter between 5 mm and 12 mm.

5. The apparatus according to claim 4, wherein The size of the linear closed configuration is small enough to be insertable into a tubular member characterized by an inner diameter of 5 mm.

6. The device according to claim 1, wherein, The tubular member is selected from the group consisting of cannulas, trocars, and tubes.

7. The apparatus according to claim 2, wherein The frame includes: Two flexible points or regions (130) opposite each other that, when pressure is applied generally perpendicular to the line connecting the two flexible points or regions, collapse outwardly to form an acute angle; and Corners (110) that are flexible enough to expand outwardly into a generally linear configuration when the pressure is applied.

8. The device according to claim 2, wherein, At least one of the following is true: The flexible points or regions include two opposite points or regions of the frame that are thinner relative to the rest of the frame, thereby providing flexibility to the frame; and Two opposite points or regions of the frame are angled outwardly such that under pressure applied in a direction generally perpendicular to the line connecting the two opposite points or regions, the two opposite points or regions will tend to deform outwardly.

9. The device according to claim 2, wherein The frame is adapted to attach the patch to the frame.

10. The apparatus according to claim 9, wherein, The frame includes a plurality of pins (140) extending out of the plane of the frame.

11. The device according to claim 9, wherein, The frame includes a plurality of retainers (360) pivotally attached to the frame, each of the retainers including a leg and a head extending generally horizontally from the leg.

12. The apparatus according to claim 2, wherein, The frame includes at least one protrusion or handle (120) extending outwardly from the frame.

13. The apparatus according to claim 2, wherein, The frame (100) includes: A lower portion (500); An upper portion (510) having a shape and size generally the same as the shape and size of the lower portion. A hinge element (520) that provides a hinge connection between the lower portion and the upper portion such that rotation about the hinge connection positions the frame in a closed jaw configuration in which the lower portion is above the upper portion and the upper and lower portions substantially overlap each other; a mechanism for reversibly locking the lower and upper portions together; lugs (560) located on two opposite sides of the upper portion; and recesses (550) located on two opposite sides of the lower portion, the recesses sized to permit insertion of each lug into a matching recess and positioned such that each lug engages a matching recess when the frame is in the closed jaw configuration.

14. The apparatus according to claim 13, wherein, The mechanism for reversibly locking the lower and upper portions together includes: a plurality of pins (530) located on the lower portion; and a plurality of holes (540) located on the upper portion, the holes sized large enough to permit the pins to pass through the holes and positioned such that the pins engage the holes when the frame is in the closed jaw configuration.

15. The device according to claim 14, wherein: each of the pins includes a lip or protrusion; the distance from the lower portion to the lip or protrusion is at least equal to the thickness of the upper portion; and, the holes intersect with slots.

16. The device according to claim 13, wherein, The frame includes corners (110) that include notches.

17. The device according to claim 2, wherein, The frame includes a biocompatible plastic.

18. The device according to claim 2, wherein The frame includes a biocompatible metal.

19. The device according to claim 2, wherein, The frame further includes at least one elongate member (490) attached to two opposite sides of the frame and bent out of the plane of the frame.

20. The apparatus according to claim 2, wherein, The device further includes a deployable bag (600) that is capable of assuming a rolled-up configuration and a deployed configuration and is configured to deploy to enclose the frame when the frame is in the closed configuration.

21. The apparatus according to claim 20, wherein, The bag is attached to the frame.

22. The apparatus according to claim 20, wherein, The device further encloses a flexible band (610) adapted to roll up or tear the bag when the bag is in the deployed configuration.

23. The device according to claim 22, wherein, The flexible band includes at least one component selected from the group consisting of: a thread; and a strip formed of a flexible biocompatible elastomer.

24. The device according to claim 1, wherein, The base includes a solid base (700) and a roller (710) attached to the base, and the base is flexible enough to be compressed to a small enough size to be inserted into a tubular member designed for use in minimally invasive surgery.

25. The device according to claim 24, wherein, The device further includes a deployable bag (600) that is capable of assuming a rolled-up configuration and a deployed configuration and is configured to deploy to enclose the frame when the frame is in the closed configuration.

26. The apparatus according to claim 25, wherein, The bag is attached to the frame.

27. The apparatus according to claim 24, wherein, The device also encloses a flexible band (610) adapted to roll up or tear the bag when the bag is in the deployed configuration.

28. The device according to claim 27, wherein, The flexible band includes at least one component selected from the group consisting of: a thread; and a strip made of a flexible biocompatible elastomer.

29. The device according to any one of the preceding claims, wherein, The device is adapted for introducing a self-adhesive hemostatic patch during a minimally invasive surgery.

30. The device according to any one of claims 1 to 28, the device for use in a method for applying a self-adhesive surgical patch during a minimally invasive surgery, the method comprising: when the frame is in the open configuration, attaching the self-adhesive surgical patch to the device, thereby forming a patch / frame assembly; applying pressure to at least two opposite sides of the patch / frame assembly, thereby converting the patch / frame assembly into the closed configuration; introducing the patch / frame assembly into a patient's body via a tubular member; re-opening the patch / frame assembly into the open configuration; placing the patch on a target tissue or organ; and separating the frame from the patch.

31. The apparatus according to claim 30, wherein, The step of placing the patch on a target tissue or organ is followed by the step of holding the patch / frame assembly in place until the self-adhesive patch is at least partially adhered to the target tissue or organ.

32. The device according to claim 30, wherein: the step of attaching the self-adhesive patch includes attaching the self-adhesive patch to the device according to claim 20; the step of applying pressure is followed by the step of deploying the bag to enclose the patch / frame assembly; and the step of introducing the patch / frame assembly is followed by the step of re-rolling up or tearing the bag thereby exposing the patch / frame assembly and releasing the pressure.

33. The apparatus according to claim 30, wherein, The self-adhesive surgical patch is a self-adhesive hemostatic patch.

34. The device according to any one of claims 24 to 28, the device being for use in a method for applying a self-adhesive surgical patch during minimally invasive surgery, wherein, The method comprises: placing the self-adhesive patch on the device, thereby forming a patch / base assembly; rolling the patch / base assembly into a column small enough to be introduced into a tubular member designed for use in a minimally invasive surgery; introducing the patch / base assembly into a patient's body via a tubular member; deploying the patch / base assembly; placing the patch on a target tissue or organ; and separating the base from the patch.

35. The apparatus according to claim 34, wherein, The step of placing the patch on a target tissue or organ is followed by the step of holding the patch / frame assembly in place until the self-adhesive patch is at least partially adhered to the target tissue or organ.

36. The device according to claim 34, wherein, the step of attaching the self-adhesive patch includes attaching the self-adhesive patch to the device according to claim 25; the step of rolling up the patch / base assembly is followed by the step of deploying the bag to enclose the patch / base assembly; and the step of introducing the patch / base assembly is followed by the step of re-rolling up or tearing the bag thereby exposing the patch / base assembly.

37. The apparatus according to claim 36, wherein, The self-adhesive surgical patch is a self-adhesive hemostatic patch.

38. The device according to claim 13, the device being for use in a method for applying a self - adhering surgical patch during a minimally invasive surgery, wherein, The method comprises: Place the self - adhering patch on the lower part such that the self - adhering patch is positioned over the recess; Rotate the upper part about the hinge member such that the tongue engages the recess, thereby holding the self - adhering patch in place; Lock the frame into a closed jaw configuration by using the locking mechanism; Apply pressure to the frame, thereby placing the frame in the closed position; Introduce the frame into the patient's body via the tubular member, thereby releasing the pressure on the frame and causing the frame to at least partially return to the open configuration; Place the patch on the target tissue or organ; and Separate the frame from the patch.

39. The apparatus according to claim 38, wherein The self - adhering surgical patch is a self - adhering hemostatic patch.

40. A kit for supplying a device for introducing a self - adhering surgical patch during minimally invasive surgery, the kit comprising: The device according to any one of claims 1 to 28; A protective sleeve (800) sized to enclose the frame when the frame is in the closed configuration; A line (810) attached to the protective sleeve; A suture holder (820) configured to hold the line before using the device; An auxiliary tube (830) configured to assist in rolling up the protective sleeve; And A tray (840) configured to hold the device, the protective sleeve, the line, the suture holder, and the auxiliary tube.

41. The kit according to claim 40, wherein The kit further comprises a medical - grade breathable paper extending over the tray, thereby sealing the kit.

42. The kit according to claim 40, wherein, The kit includes the device according to claim 13.

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