Device for delivering a surgical patch during minimally invasive surgery

Abstract

A device for the introduction and delivery of a self-adhesive surgical patch during minimally invasive surgery is disclosed. The device comprises a base that can be compressed to fit within a tubular member with 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 while the frame is in a planar, open configuration. Pressure is then applied to opposite sides of the frame to compress the frame to a straight, closed configuration small enough to penetrate a tubular member with an inner diameter of 5 mm. After penetrating the tubular member, the frame reopens to its open configuration, allowing the patch to be delivered and applied to the target tissue. A kit for providing the device is also disclosed.

Description

[Technical Field]

[0001] This application is a domestic application of PCT international patent application PCT / IL2023 / 051177 filed on November 14, 2023, and claims priority from U.S. Provisional Patent Application No. 63 / 424,982 filed on November 14, 2022.

[0002] The present invention relates generally to devices for use in minimally invasive surgery, and more particularly to devices for delivering self-sealing surgical patches, such as hemostatic patches, during minimally invasive surgery, and methods for carrying out the same. [Background technology]

[0003] Self-sealing surgical patches, such as hemostatic patches, are used during minimally invasive procedures, such as laparoscopic surgery, to seal wounds and to effect hemostasis by sealing tissue or organs. Numerous devices and methods have been developed to deliver self-sealing patches to a desired site.

[0004] U.S. Patent No. 5,397,332 discloses an applicator for sheets of surgical material, such as surgical patches. The applicator typically includes an expandable spreader tip housed in a folded configuration within a delivery tube. The elongated tube is introduced into the body. The delivery tube is retracted and an actuator expands the spreader tip, which is then used to apply the surgical material. The spreader tip is made of stainless steel.

[0005] 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 and placed inside a plastic bag. The plastic bag containing the patch is then inserted into a body cavity via an elongated tube. The plastic bag is removed, and the patch is then unrolled and applied to the desired tissue.

[0006] U.S. Patent Application Publication No. 2003 / 0073979 discloses a device for delivering patches. The device includes an expandable umbrella- or basket-shaped assembly. The assembly is held in a retracted configuration inside a delivery tube. When the device is extended from the delivery tube, it expands to its normal configuration and is used to deliver a patch attached to the device to tissue. In some embodiments, the device is self-expanding. The expandable element can be made from a wire constructed from a material such as nitinol, stainless steel, platinum, or other material with superelastic properties.

[0007] U.S. Patent Application Publication No. 2009 / 0030435 discloses a device for anchoring cardiovascular implants. In some embodiments of the invention, the anchors are expandable upon deployment, being held within a cannula or tube in a compressed form and then expanding after being ejected from the tube. The anchors can be made of "standard" materials such as stainless steel or nitinol.

[0008] U.S. Patent Application Publication No. 2014 / 0277579 discloses a structure for use in minimally invasive surgery. The structure comprises an allograft patch having at least one layer of human amniotic and chorionic tissue and a foldable rigid or semi-rigid frame. The patch is attached to the frame, which expands to its final shape after exiting a cannula inserted into the patient's body, allowing the patch to be applied to tissue. Preferred shapes for the frame include hemispherical, multi-spoke, and cylindrical.

[0009] WO 2011 / 128903 discloses a device for delivering and positioning a deployable sheet in minimally invasive surgery. The device includes a self-expanding assembly, which may include multiple spokes that bend back on a guide rod in a collapsed configuration. The deployable sheet is attached to the expandable end, and the device is inserted into a tube. When the device exits the tube, the assembly expands, allowing for delivery and positioning of the deployable sheet.

[0010] WO 2015 / 111040 discloses a device for use in ophthalmic surgery, particularly for removing Descemet's membrane. The device includes a semi-rigid circular frame, which can be made of any material capable of retaining its shape, including plastic and metal alloys. The frame is inserted into a conical inserter head in its collapsed form, and upon exiting the inserter, the frame expands to its final circular shape, typically measuring 0.5 mm thick and 9-10 mm in diameter.

[0011] From the above, it is clear that although many devices and techniques have been developed for the delivery of surgical patches during minimally invasive surgery, the devices and methods known in the art tend to be complex and cumbersome for surgeons. Thus, there remains a longstanding but unmet need for improved devices and methods for the delivery of self-adhesive tissue patches, particularly hemostatic patches, in minimally invasive surgery. [Prior art documents] [Patent documents]

[0012] [Patent Document 1] U.S. Patent No. 5,397,332 [Patent Document 2] U.S. Patent No. 10,595,978 [Patent Document 3] US Patent Application Publication No. 2003 / 0073979 [Patent Document 4] US Patent Application Publication No. 2009 / 0030435 [Patent Document 5] US Patent Application Publication No. 2014 / 0277579 [Patent Document 6] International Publication No. 2011 / 128903 [Patent Document 7] International Publication No. 2015 / 111040 [Patent Document 8] U.S. Patent No. 10,905,792 [Patent Document 9] U.S. Patent No. 1,107,1805 [Patent Document 10] U.S. Patent No. 1,147,1556 [Patent Document 11] U.S. Patent No. 1,177,1799 Summary of the Invention

[0013] The invention disclosed herein is designed to meet this need. A device and method for the introduction of a self-adhesive tissue patch is disclosed, wherein the device and patch can be introduced through a tubular member typically used in minimally invasive surgery, such as a trocar, and the device can be withdrawn through the same tubular member after application of the patch, without premature activation of the patch, and the entire process of introducing the device and patch, applying the patch to the desired tissue and organ, and withdrawing the device can be performed using only standard graspers used in minimally invasive surgery.

[0014] Accordingly, one object of the present invention is to disclose a device for introducing a self-adhesive surgical patch during minimally invasive surgery, said device comprising a flexible base, said base being sufficiently flexible and having a member of sufficiently small dimensions such that said base can be compressed to a size small enough to be inserted into a tubular member designed for use in minimally invasive surgery.

[0015] It is a further object of the present invention to disclose such a device, wherein the base comprises a frame (100) in an essentially planar open configuration, of dimensions large enough to support the surgical patch, which upon application of pressure within the plane compresses to a linear closed configuration, which linear closed configuration is small enough to be inserted into a tubular member designed for use in minimally invasive surgery, and which at least partially reopens to the open configuration upon release of the pressure. In some embodiments of the device, the linear closed configuration is small enough to be inserted into a tubular member characterized by an internal diameter of 5 mm to 12 mm. In some embodiments of the device, the linear closed configuration is small enough to be inserted into a tubular member characterized by an internal diameter of 5 mm. In some embodiments of the invention, the tubular member is selected from the group consisting of a cannula, a trocar, and a tube.

[0016] It is a further object of the present invention to disclose an embodiment of the device in which the base comprises a frame, the frame comprising two flexible points or regions (130) opposite each other that fold outward to form an acute angle upon application of said pressure essentially perpendicular to the line connecting said two flexible points or regions, and corner portions (110) that are sufficiently flexible to expand outward into an essentially straight configuration upon application of said pressure.

[0017] It is a further object of the present invention to disclose an embodiment of the device in which the base comprises a frame, and at least one of the following applies: two opposing points or areas of the frame are thinned relative to the remainder of the frame, thereby making the frame flexible; and the two opposing points or areas of the frame are angled outward so as to tend to bend outward under pressure applied in a direction generally perpendicular to the line connecting the two opposing points or areas.

[0018] It is a further object of the present invention to disclose a device as defined in any of the above, wherein the frame is adapted to attach the patch to the frame. In some embodiments of the present invention, where the frame is adapted to attach the patch to the frame, the frame comprises a plurality of pins (140) extending from the plane of the frame. In some embodiments of the present invention, where the frame is adapted to attach the patch to the frame, the frame comprises a plurality of holders (360) pivotally attached to the frame, each holder comprising a leg and a head extending essentially horizontally from the leg.

[0019] It is a further object of the present invention to disclose an embodiment of the device wherein said base comprises a frame as defined above, said frame comprising at least one recess along its periphery.

[0020] It is a further object of the present invention to disclose embodiments of the device wherein the base comprises a frame as defined above, the frame comprising at least one tab or handle (120) extending outwardly from the frame. In some preferred embodiments of the present invention, the tab or handle is essentially in the plane of the frame.

[0021] It is a further object of the present invention to disclose an embodiment of the device as defined in any of the above, wherein said frame (100) comprises a lower portion (500), an upper portion (510) of substantially the same shape and dimensions as said lower portion, and a hinge element (520) providing a hinge connection between said lower portion and said upper portion, such that by rotating about said hinge connection, said frame can be rotated in a closed-jaw configuration, in which said lower portion rests on said upper portion and said upper and lower portions substantially mate with each other. a mechanism for reversibly locking the lower and upper portions together; tongues (560) on two opposite sides of the upper portion; and grooves (550) on two opposite sides of the lower portion, the grooves (550) being sized to allow insertion of each tongue into a matching groove and positioned so that each of the tongues engages with a matching groove when the frame is in the closed-jaw configuration.

[0022] In some preferred embodiments of the invention, in which a frame comprises a lower portion and an upper portion, the mechanism for reversibly locking the lower portion and the upper portion together comprises 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 and positioned so that the pins engage the holes when the frame is in the closed-jaw configuration. In some particularly preferred embodiments, each of the pins comprises a lip or protrusion, the distance from the lower portion to the lip or protrusion being at least equal to the thickness of the upper portion, and the holes intersect with a slot.

[0023] In some preferred embodiments of the present invention, where the frame comprises a lower portion and an upper portion, the frame comprises corner portions (110) incorporating recesses.

[0024] It is a further object of the present invention to disclose an embodiment of the device in which said base comprises a frame as defined above, said frame comprising a biocompatible plastic.

[0025] It is a further object of the present invention to disclose an embodiment of the device in which said base comprises a frame as defined above, said frame comprising a biocompatible metal.

[0026] It is a further object of the present invention to disclose an embodiment of the device wherein the base comprises a frame as defined above, the frame further comprising at least one elongated member (490), the elongated member being attached to two opposite sides of the frame and curved out of the plane of the frame.

[0027] Accordingly, one object of the present invention is to disclose a device for deploying a self-adhesive surgical patch during minimally invasive surgery, said device comprising a flexible base (700) constructed from a biocompatible elastomer and a roller (710) attached to said flexible base, said base being sufficiently flexible so that it can be compressed to a size small enough to be inserted into a tubular member designed for use in minimally invasive surgery. In a preferred embodiment of the invention, the base is sufficiently thin so that when rolled into a substantially cylindrical shape it has a cross-section characterized by a maximum lateral dimension of 5 mm or less.

[0028] It is a further object of the present invention to disclose an apparatus as defined in any of the above, wherein the device further comprises a pouch (600), capable of adopting a rolled and an unrolled configuration, and configured to be unrolled to enclose the frame when the frame is in the closed configuration. In some preferred embodiments of the present invention, the pouch is attached to the frame. In some preferred embodiments of the present invention, wherein the device comprises a pouch, the device further encloses a flexible band (610) adapted to roll or tear the pouch when the pouch is in the unrolled 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 ribbon made of a flexible biocompatible elastomer.

[0029] A further object of the present invention is to disclose a device as defined in any of the above, said device being adapted to introduce a self-adhesive hemostatic patch during minimally invasive surgery.

[0030] It is a further object of the present invention to disclose a device as defined in any of the above, wherein said frame comprises sides having a cross-sectional shape and size selected from the group consisting of a substantially rectangular cross-section characterized by a side length of 2.5 mm or less, a substantially circular cross-section characterized by a diameter of 2.5 mm or less, a substantially elliptical or oval cross-section characterized by a major axis of 2.5 mm or less, a substantially polygonal n-sided cross-section (n≠4), and any combination of the above.

[0031] It is a further object of the present invention to disclose a method for applying a self-adhesive surgical patch during minimally invasive surgery, said method comprising: If the device comprises a frame, (a) applying the self-adhesive patch to said frame while said frame is in said open configuration, thereby forming a patch / frame assembly; and (b) applying pressure to at least two opposing edges of said patch / frame assembly, thereby deforming said patch / frame assembly to said closed configuration. If the device comprises a thin, flexible base, (a) placing the self-adhesive patch on a surface of the base, thereby forming a patch / base assembly; and (b) rolling the patch / base assembly into a cylinder small enough to be introduced into a tubular member designed for use in minimally invasive surgery. (c) introducing the patch / frame assembly or the patch / base assembly through a tubular member; (d1) reopening the patch / frame assembly to the open configuration if the device comprises a frame; (d2) unfolding the patch / base assembly if the device comprises a thin, flexible base; (e) placing the patch on a target tissue or organ; and (f) detaching the frame or base from the patch. Includes.

[0032] It is a further object of the present invention to disclose such a method, 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 has at least partially adhered to the target tissue or organ.

[0033] A further object is to disclose a method as defined in any of the above, wherein the device comprises an expandable pouch, and wherein step (b) of applying pressure to at least two opposing sides of the patch / frame assembly, thereby deforming the patch / frame assembly into the closed configuration, or rolling the patch / base assembly into a cylindrical shape small enough to be introduced into a tubular member designed for use in minimally invasive surgery, is followed by a step of unfolding the expandable pouch to enclose the patch / frame assembly or the patch / base assembly, and wherein the step of introducing the patch / frame or the patch / base assembly is followed by a step of rerolling or tearing the pouch, thereby exposing the patch / frame assembly or the patch / base assembly.

[0034] A further object of the present invention is to disclose a method as defined in any of the above, wherein said self-adhesive patch is a self-adhesive hemostatic patch.

[0035] It is a further object of the present invention to disclose a method as defined in any of the above, wherein the step of placing the patch on a target tissue or organ is followed by a step of holding the patch / frame assembly in place until the self-adhesive patch at least partially adheres to the target tissue or organ.

[0036] It is a further object of the present invention to disclose a method as defined in any of the above for use in a method as defined in any of the above.It is a further object of the present invention to disclose the use of a device as defined in any of the above in a method as defined in any of the above.

[0037] A further object of the present invention is to disclose a kit for supplying a device for introducing a self-adhesive surgical patch during minimally invasive surgery, the kit comprising: a device as defined in any of the above; a protective sleeve (800) of sufficient dimensions to enclose the frame when the frame is in a closed configuration; a thread (810) attached to the protective sleeve; a suture holder (820) configured to hold the thread prior to use of the device; an auxiliary tube (830) configured to assist in winding the protective sleeve; and a tray (840) configured to hold the device, the protective sleeve, the thread, the suture holder, and the auxiliary tube. In some preferred embodiments of the kit, the kit further comprises medical-grade breathable paper that extends over the tray to seal the kit. In some particularly preferred embodiments of the kit, the kit comprises a device as defined in any of the above, comprising a frame including a lower portion (500) and an upper portion (510).

[0038] The present invention will now be described with reference to the drawings. [Brief explanation of the drawings]

[0039] [Figure 1] 1 is a schematic diagram showing several views of one non-limiting example of a frame for delivering an inventive surgical patch disclosed herein; [Figure 2A] 1A and 1B illustrate schematic diagrams of the transformation of one embodiment of a frame disclosed herein between an open (planar) and a closed (rectilinear) configuration. [Figure 2B] 1A and 1B illustrate schematic diagrams of the transformation of one embodiment of a frame disclosed herein between an open (planar) and a closed (rectilinear) configuration. [Figure 3] 1 is a schematic diagram showing several views of another non-limiting example embodiment of a frame for delivering an inventive surgical patch disclosed herein; [Figure 4A]A non-limiting example of a frame for delivering a patch is shown schematically, the frame including pivotable holders for securing the patch to the frame, the holders being arranged to allow the patch to be placed on the frame and the patch to be grasped, respectively. [Figure 4B] A non-limiting example of a frame for delivering a patch is shown schematically, the frame including pivotable holders for securing the patch to the frame, the holders being arranged to allow the patch to be placed on the frame and the patch to be grasped, respectively. [Figure 5A] 1A and 1B are schematic top views of one embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame incorporating elements designed to apply pressure to the surgical patch as the patch is applied to tissue. [Figure 5B] 1A and 1B are schematic side views of one embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame incorporating elements designed to apply pressure to the surgical patch as the patch is applied to tissue. [Figure 6A] 10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 6B] 10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 6C] 10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 6D] 10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 6E]10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 6F] 10A-10C are schematic views of another embodiment of a frame for delivering a surgical patch according to the invention disclosed herein, the frame being in a jaw-like configuration; [Figure 7] 10 is a schematic representation of one non-limiting embodiment of the present invention, including an expandable pouch that can be expanded to enclose the frame when in a linear configuration, and a flexible band for removing or tearing the pouch after the frame assembly exits the tubular member through which it is introduced. [Figure 8A] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8B] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8C] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8D] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8E] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8F] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8G] 10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 8H]10 illustrates the use of a pouch, as shown diagrammatically in FIG. 7, to enclose and introduce the inventive patch / frame assembly disclosed herein. [Figure 9A] 1 shows a schematic representation of some of the views of one non-limiting embodiment of the present invention, in which the patch is placed on a flexible base that is rolled into a cylindrical shape before being introduced into the patient's body. [Figure 9B] 1 shows a schematic representation of some of the views of one non-limiting embodiment of the present invention, in which the patch is placed on a flexible base that is rolled into a cylindrical shape before being introduced into the patient's body. [Figure 9C] 1 shows a schematic representation of some of the views of one non-limiting embodiment of the present invention, in which the patch is placed on a flexible base that is rolled into a cylindrical shape before being introduced into the patient's body. [Figure 9D] 1 shows a schematic representation of some of the views of one non-limiting embodiment of the present invention, in which the patch is placed on a flexible base that is rolled into a cylindrical shape before being introduced into the patient's body. [Figure 10A] 1A and 1B show schematic exploded views of kits with components for delivering surgical patches during minimally invasive surgery. [Figure 10B] 1A and 1B schematically illustrate a folded view of a kit comprising components for delivering a surgical patch during minimally invasive surgery. [Figure 11A] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11B] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11C] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11D] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11E] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11F]11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11G] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. [Figure 11H] 11A and 11B are schematic diagrams illustrating the use of the kit shown in FIG. 10 to thread a hemostatic patch through a trocar with an inner diameter of 5 mm. DETAILED DESCRIPTION OF THE INVENTION

[0040] It is emphasized that the drawings are presented for illustrative purposes only to assist one of ordinary skill in the art in making and using the invention disclosed herein. Unless expressly stated to the contrary herein, any specific shapes, specific dimensions, or specific relative shapes or dimensions generally shown in the drawings should not be construed as limiting in any way.

[0041] In the following description, various aspects of the present invention are described. For purposes 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 in which the details differ without affecting the essential characteristics of the present invention. Accordingly, the present invention is not limited by what is shown in the drawings and described in the specification, but only as set forth in the appended claims, the appropriate scope of which is determined solely by the broadest reasonable interpretation of such claims. In some cases, for clarity or brevity, individual elements of the present invention are described separately. Nevertheless, any combination of the individual elements of the present invention disclosed herein that is not self-contradictory is deemed by the inventors to be within the scope of the present invention.

[0042] In all cases where an embodiment is described as "comprising" a set of elements or method steps, i.e., the invention may include elements or method steps in addition to those explicitly recited, the scope of the invention is understood to also include embodiments in which the invention "consists of" the recited elements or method steps, i.e., embodiments that include the recited elements or method steps and none others, and embodiments in which the invention "consists essentially of" the recited elements or method steps, i.e., embodiments that do not include unrecited elements or method steps that materially affect the basic and novel characteristics of the invention.

[0043] Unless otherwise specified, any numerical range disclosed herein is understood to include any subranges therein. As a non-limiting example, if a range is stated as "1 to 10%," ranges of 1 to 5%, 2 to 9%, etc. are considered by the inventors to be within the scope of the invention. Similarly, if a range is stated as "less than 50%," ranges of less than 40%, less than 25%, less than 10%, etc. are considered to be within the scope of the invention.

[0044] As used herein, when referring to a numerical quantity, the term "about" refers to a tolerance of ±25% about the nominal value.

[0045] In describing and illustrating the various embodiments of the invention disclosed herein, like reference numerals refer to like parts of the invention.

[0046] As used herein, when referring to a surgical patch, the term "self-adhesive" refers to a patch that adheres to tissue or organs without the need for the addition of a substance to stick or adhere the patch to the tissue or organ and without the need for a means of attachment external to the patch, such as sutures or staples. Unless otherwise specified, patches in which an adhesive is applied or embedded as part of the manufacturing process and patches in which an adhesive is applied after manufacture at any time prior to application to the target tissue or organ are within the scope of this definition.

[0047] As used herein, the term "tubular member" refers to an elongated structure having at least one passageway extending entirely through the structure along its longitudinal axis. Non-limiting examples of tubular members include trocars, cannulas, and tubes.

[0048] As used herein, the term "polygon" is used to describe a shape having at least three essentially straight sides that together form a closed, essentially planar structure. Non-limiting examples of structures that are considered "polygons" within the scope of the term as used herein include closed figures with straight sides and vertices, structures with rounded corners, structures with rounded sides, structures with curved sides, and structures with sides with indentations or protrusions.

[0049] For simplicity and clarity of presentation, the term "device" is used generically to describe the inventions disclosed herein. Use of this term should not be construed as an assertion, approval, or acceptance regarding whether any embodiment of the invention disclosed herein is considered a "device" or an "accessory" as these terms are defined by the U.S. Food and Drug Administration, and no such assertion, approval, or acceptance should be inferred from use herein of the term "device" in any description of the invention. Additionally, use of the term "device" should not be understood as necessarily excluding "accessories" from the scope of any claim.

[0050] The present invention discloses novel devices and methods for deploying self-adhesive surgical patches, such as hemostatic patches, during minimally invasive surgery, where the patch is reversibly attached to a base that can be contracted to fit within a tubular member designed for use in minimally invasive surgery. In exemplary, non-limiting embodiments of the present invention, the base is contractible to fit within a tubular member having an inner diameter of 5-12 mm. In preferred embodiments of the present invention, the base is contractible 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 the patch / base assembly is introduced through the tubular member (e.g., a 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 the patch is attached on at least two of its edges, while in other embodiments, the base is a thin, flexible support at least as large as the patch, and the patch rests on the flexible support prior to deployment. In some embodiments of the present invention, the present invention is adapted for the delivery of hemostatic patches. In some preferred embodiments of the present invention, the present invention is adapted for the delivery of hemostatic patches that utilize a thrombin / fibrinogen sealant to affix the patch to a target organ or tissue. In some particularly preferred embodiments of the present invention, the present invention is adapted for the delivery of hemostatic patches of the type disclosed in U.S. Patent Nos. 10,905,792, 11,071,805, 11,471,556, and 11,771,799.

[0051] In some preferred embodiments of the invention disclosed herein, a device for delivering a surgical patch includes a frame (100) made of a compliant material. That is, the material from which the frame is constructed allows the frame to compress when a force is applied and at least partially return to its original configuration when the force is released. The surgical patch is attached to and delivered from the frame, as described in detail below. The frame can be made of any biocompatible, compliant material that is rigid enough to support the patch but flexible enough to allow it to be opened and closed, 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, as well as biocompatible metals such as stainless steel and nitinol.

[0052] Referring now to FIG. 1, FIG. 1 provides a schematic diagram showing several views of one non-limiting embodiment 1000 of a device for delivering a surgical patch disclosed herein. In the illustrated embodiment, the frame (100) is essentially square with sides approximately 50 mm long. In a typical embodiment, the sides of the frame have a substantially rectangular, preferably square, cross-sectional shape. Other shapes, including, but not limited to, cross-sectional shapes with rounded corners, cross-sectional shapes with rounded or curved sides, generally round shapes such as circles or ellipses, and substantially polygonal shapes with n sides (n≠4), are all considered by the inventors to be within the scope of the present invention. In embodiments in which the sides of the frame are substantially rectangular, the width and depth of the frame (i.e., the length of the sides of the rectangular cross-section) are typically 2-2.5 mm. The corner portions (110) of the frame are sufficiently flexible so that when pressure is applied to two opposite sides of the frame, two diagonally opposite corner portions will fully open and the remaining corner portions will fully close, causing the frame to transform from the illustrated polygonal, essentially planar "open" configuration to a "closed" configuration in which the frame adopts an essentially rectilinear structure.

[0053] Thus, while in its closed configuration, the frame can be inserted into a tubular member, such as a trocar, designed for use in minimally invasive surgery. In those preferred embodiments in which the frame's sides are characterized by width and depth dimensions (e.g., the frame's side length or its maximum cross-sectional diameter) of 2.5 mm or less, the frame in its closed configuration therefore has a lateral dimension of 5 mm or less and, therefore, in its closed configuration, can be inserted into a tubular member, such as a trocar, having an inner diameter of 5 mm. In these preferred embodiments, the frame in its closed configuration can be inserted into a trocar characterized by an inner diameter of 5 mm; however, frames adapted for insertion into tubular members of other inner diameters (non-limiting examples of which include standard trocars characterized by inner diameters of 5-12 mm, such as a 6 mm inner diameter trocar, a 10 mm inner diameter trocar, and a 12 mm inner diameter trocar) are considered by the inventors to be within the scope of the present invention. 1, the frame incorporates at least one tab or handle 120 extending outwardly from the frame to make it easier for a surgeon to grasp and compress the frame using standard graspers used in minimally invasive surgery. In a preferred embodiment of the invention, the tab or handle is essentially in the plane of the frame, although configurations in which the tab is not flush with the frame are considered by the inventors to be within the scope of the invention.

[0054] The frame can be manufactured by any method known in the art for producing a structure of the desired size and shape from a selected material, non-limiting examples include injection molding, 3D printing, and extrusion.

[0055] The frame embodiment shown in FIG. 1 includes multiple pins 140 extending from one side of the frame. These pins are intended to secure a surgical patch to the frame. The patch is unrolled onto the frame and pulled over the pins, which penetrate or puncture the patch, holding it to the frame's edge without disturbing its center. In the illustrated embodiment, the frame incorporates six pins, three on each of two opposing sides. In this embodiment, the pins feature a height and depth of approximately 2-2.5 mm. As shown, in an exemplary embodiment of the invention, the pins are not perfectly cylindrical, but rather include an extension or lip at the top to better grip the patch when placed on the frame. It is emphasized that the number, exact size, and shape of the pins should not be considered limiting by the drawings. In embodiments in which the patch is secured to the frame through the use of pins, any convenient number of pins of any size large enough to secure the patch to the frame and small enough so that in the closed configuration of the frame the frame can fit within a tubular member designed for use in minimally invasive surgery, as well as any convenient shape for attaching the patch, can be used.

[0056] 2A and 2B, which schematically illustrate the transformation of an exemplary, non-limiting embodiment of a frame between an open and a closed configuration. In the illustrated, non-limiting embodiment, the frame includes two flexible points or regions 130 on opposite sides. Flexibility can be provided by recessing the frame at these two points, as shown in FIG. 2A, and the two flexible points are indicated by circles. In some preferred embodiments of the present invention, the frame is angled slightly outward at these points to facilitate folding outward rather than inward. As shown schematically in FIG. 2A, the frame is transformed from its planar, open configuration to a closed, linear configuration by applying pressure, as indicated by the arrows, to the two opposite sides of the frame that do not include the flexible points. As shown in Figure 2B, when pressure is applied in this manner, the two flexible points or regions fold outward to form an acute angle, as indicated by the solid circle, approaching a zero-degree angle at the fully collapsed limit, and the corner portion of the frame expands to an essentially linear configuration, with the change in angle between two adjacent points indicated by the dashed circle. When pressure is released, the frame made of compliant material at least partially returns to its essentially polygonal open configuration. When pressure is released, the frame only partially reopens, and grasping and pulling the partially open frame outward can fully return it to its open configuration, thereby returning the frame to its fully open configuration, and embodiments are considered by the inventors to be within the scope of this invention.

[0057] Reference is now made to Figure 3, which provides a schematic diagram illustrating several views of another non-limiting embodiment of the present invention 2000. The frame shown in Figure 3 is essentially similar to the frame shown in Figures 1 and 2, except that rather than having a recess on the periphery of one side of the frame, two opposing sides of the frame have tabs 120 extending outward from the frame, which in the preferred embodiment are essentially in the plane of the frame.

[0058] Referring now to FIG. 4, FIG. 4 illustrates a third non-limiting embodiment 3000 of the present invention incorporating an alternative mechanism for attaching a patch to a frame. In this embodiment, multiple pivotally mounted holders 360 are attached to the periphery of the frame. A typical non-limiting embodiment is shown in FIG. 4A. In the illustrated embodiment, multiple holders (four in the illustrated embodiment) are pivotally mounted to the periphery of the frame. The direction of the holder pivots is indicated in the figure by arrow 370. The holders include legs and a head extending essentially horizontally from the head. In a preferred embodiment of the present invention, the head has recesses such that the head can grip or attach to the frame when the legs rotate about a pivot point on the frame. A configuration in which the holder is pivoted to hold a patch 180 on the frame is shown in FIG. 4B. When the surgeon wishes to deploy the patch, the holder is pivoted back to a position where it no longer grips the patch, and the patch is removed from the frame. This embodiment of the means for attaching the patch has the advantage that the patch can be attached to and removed from the frame without puncturing the patch.

[0059] Many self-adhesive surgical patches, particularly those whose adhesive is activated by contact with bodily fluids, require the application of pressure for a short period of time after delivery to ensure complete adhesion to the tissue or organ to which they are delivered. Referring now to FIG. 5, FIG. 5 provides a schematic diagram of one non-limiting embodiment 4000 of the inventive frame disclosed herein, in which the frame incorporates an element that provides such pressure. A top view of a typical configuration is shown in FIG. 5A. The frame incorporates flexible, elongated elements 490 attached to two opposing sides of the frame. In the illustrated embodiment, the elements are curved along their length in a generally "S" shape. This type of shape is preferred as it maximizes contact with the patch, but should by no means be considered limiting. The elements may adopt any convenient shape that allows the frame to transform into a straight, closed configuration that fits within a tubular member designed for use in minimally invasive surgery, such as a 5 mm inner diameter trocar. A side view of a frame according to this embodiment is shown schematically in FIG. 5B. As can be seen, the elongated elements are not in the plane of the frame, but rather extend outside of the plane in a curved configuration. When the system is assembled, the patch is placed on the side of the frame, where the elongated elements rise outside of the plane of the frame, preferably positioned firmly enough so that the elongated elements are at least partially deformed toward the plane of the frame. When the patch is delivered, the elongated elements apply pressure to the patch while the frame holds it in place at the patch delivery site. Once the adhesive of the patch is sufficiently activated to adhere to the tissue to which it is applied, the frame can be removed.

[0060] Insertion and application of the patch can be performed as follows: The patch is attached to the frame as described above with the adhesive side of the patch facing up, i.e., not in direct physical contact with the frame, thereby forming a patch / frame assembly. This step can be performed in a sterile environment, such as a clean room, with the patch / frame assembly placed in a sterile package for use in surgery, or the assembly can be performed in the operating room prior to use in minimally invasive surgery. The assembly is then folded into the closed, linear configuration of the frame, and the assembly is introduced into the patient's body through a tubular member designed for use in minimally invasive surgery (e.g., a 5 mm internal diameter trocar). After the assembly is inserted, pressure on the edges of the frame is released, causing the frame to at least partially reopen toward its open configuration. In some embodiments of the present invention, the frame is made of a material that does not automatically return completely to the open configuration. In these embodiments, the frame is reopened using a pair of graspers. The patch / frame assembly is then manipulated to the application site and placed on the tissue or organ to which the patch is to be applied, with the patch side of the assembly in contact with the tissue or organ. In preferred embodiments of the invention, the adhesive is activated at this point, for example, by reaction with bodily fluids on the surface of the tissue or exuding from the tissue. Once the patch has sufficiently adhered to the tissue, the frame is detached, leaving the patch recompressed to its linear configuration and removed through a tubular member designed for use in minimally invasive surgery (typically, but not necessarily, the tubular member through which the frame is introduced).

[0061]

[0031] Referring now to Figure 6, Figure 6 shows several views of an additional embodiment 5000 of the frame of the present invention disclosed herein, where the frame has a jaw-like configuration in which the frame has two portions that are in an open-jaw configuration prior to placement of a patch, and that overlap and close to form a closed-jaw configuration to hold the patch after placement of the patch on the frame.

[0032] Referring now to Figure 6A, Figure 6A schematically shows a preferred embodiment of the present invention. The frame (100) has two portions, a lower portion 500 and an upper portion 510, of essentially the same shape and dimensions. In an exemplary, non-limiting embodiment of the present invention, the lower portion 500 and the upper portion 510 are each essentially rectangular and measure approximately 5 x 7 cm when the frame is in its open configuration (i.e., before being compressed into a closed configuration for insertion into a tubular member). The lower portion 500 and the upper portion 510 are hingedly connected with a hinge element 520, which allows the upper and lower portions to rotate relative to one another about an axis passing through the connector while substantially maintaining their position relative to a plane perpendicular to the axis. The hinge element 520 need not be an actual hinge, but may be any flexible structure that allows relative movement of the two portions of the frame. By way of non-limiting example, in the embodiment shown schematically in FIG. 6A, the hinge element comprises a piece of flexible plastic connecting the two portions of the frame. In a preferred embodiment of the invention, the lower portion 500 comprises a tab or handle 120 on the side opposite the side connected to the hinge element that is substantially flush with the lower portion 500. In a preferred embodiment of the invention, the hinge element incorporates a slot such that the hinge element forms a second tab or handle when the upper and lower portions of the frame engage with one another. Such an embodiment is shown schematically in FIG. 6A.

[0062] In a preferred embodiment, the frame includes a mechanism for reversibly locking the upper and lower portions together once they are joined after rotating about the hinge elements. A non-limiting example of a reversible locking mechanism is shown in FIG. 6A. The lower portion of the frame includes a plurality of pins 530 arranged around the periphery of the frame. It is emphasized that, in contrast to embodiments of the present invention such as those shown in FIGS. 1 and 3, the pins 530 do not engage with the patch. On the edge of the lower portion of the frame adjacent to the edge connected to the hinge elements, the pins are spaced apart by a distance greater than one dimension of the patch, such that the patch can rest on the lower portion of the frame without being punctured or engaged by the pins 530. The upper portion of the frame includes a plurality of holes 540 sized and spaced to engage the pins such that, when the pins engage the holes, the two portions of the frame overlap and their perimeters substantially match. Close-up views of the holes and pins are shown in FIGS. 6B and 6C, respectively. In a preferred embodiment of the invention, the pin is not cylindrical, but rather includes a lip or protrusion, as shown in FIG. 6C. In a preferred embodiment of the invention, hole 540 passes completely through the upper portion of the frame and intersects with slot 545. Slot 545 provides the area around hole 540 with enough flexibility to allow the pin to pass through without damaging the upper portion of the frame. In an embodiment such as that shown in FIG. 6, the reversible locking mechanism works by threading the pin through the matching hole until the lip on the top of the pin appears and engages the upper portion of the frame. Referring now to FIG. 6D, which shows a close-up view of the pin and hole when the frame is in its closed and locked configuration.

[0063] In a preferred embodiment of the jaw embodiment (5000) of the present invention, the corners 110 of the upper and lower portions of the frame incorporate indentations to increase their flexibility, thereby allowing the user to more easily compress the frame into a tubular member designed for use in minimally invasive surgery, preferably to a size that will fit within a trocar with an internal diameter of 5 mm. Close-up views of the corners according to this embodiment are shown schematically in Figures 6B and 6C.

[0064] To hold the patch in place, the lower portion of the frame includes grooves 550 on opposite sides of the frame, preferably on the side adjacent to the side attached to the hinge element. 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 on opposite sides of the frame that are no longer than the grooves and are positioned so that the tongues engage the grooves when the two parts of the frame are brought into contact by rotation about the hinge element.

[0065] Referring now to FIG. 6E, FIG. 6E provides a detailed cross-sectional schematic diagram of a tongue and groove system for holding a patch within a frame. The left side of the diagram shows a view along section AA of the upper portion of the frame, and the right side of the diagram shows a view along section BB of the lower portion of the frame. As can be seen, 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 FIG. 6D, the tongue and groove are generally cylindrical or semi-cylindrical, however, this particular shape should not be considered limiting, and any shape for the groove and tongue that can engage with each other, hold the patch in place, and separate from each other upon application of sufficient force is considered by the inventors to be within the scope of the present invention.

[0066] To hold the patch in place, the patch is placed across the lower portion of the frame so that the patch rests on the two grooves. The upper portion then rotates about the axis defined by the hinge connector, thereby engaging the lower portion and placing the frame in a closed jaw configuration. The two portions of the frame are locked together by a locking mechanism (e.g., the pin and alignment holes described above), while the patch is held in place by engagement with the tongue and groove. Referring now to FIG. 6F, this shows the frame in a closed configuration, holding the patch between the two portions of the frame. In the illustrated embodiment, the hinge element is designed such that when the frame is in its closed configuration, the hinge element forms a second tab 120.

[0067] To simplify the introduction of the patch / frame assembly into the 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. Referring now to FIG. 7, FIG. 7 illustrates a non-limiting embodiment 6000 of the present invention including such a pouch (600). In the illustrated embodiment, the pouch is physically attached to the frame; however, embodiments in which the pouch is an independent component of the system are considered by the inventors to be within the scope of the present invention. The pouch can be made of any biocompatible elastomer that can be rolled into an essentially flat configuration and then expanded to enclose the frame. Non-limiting examples of such elastomers include silicone, polyurethane, polyisoprene, and latex. The patch / frame assembly is compressed into a closed, linear configuration, the pouch is expanded to enclose the assembly, and the pouch is then inserted through the tubular member. Reference is now made to Figures 8A-8H, which show successive steps of the procedure for encapsulation and introduction of the patch / frame assembly by using the pouch shown schematically in Figure 7.

[0068] In some preferred embodiments of the present invention in which the system includes an expandable pouch, a flexible band 610 designed to tear or unfold the pouch is also provided. Such a band is shown diagrammatically in FIG. 7. Like the pouch, the band may be attached to the frame or included as a separate component. Non-limiting examples of flexible band designs include threads and ribbons made of biocompatible materials such as polyethylene. After the assembly is introduced into the patient's body, the flexible band can be used to tear the pouch (if the band is in the form of a thread) or rewrap the pouch (if the band is in the form of a ribbon), and then remove the pouch along with the frame once the pouch is deployed. In some preferred embodiments of the present invention in which the flexible band comprises a thread, the pouch includes a weakened portion along its length to facilitate tearing. As a non-limiting example, the pouch may be scored along its length.

[0069] It is also within the scope of the present invention to disclose embodiments of the present invention in which the base is not an open frame to which the patch is attached at its edges, as described above, but rather a thin, flexible, solid base upon which the patch rests. The base can be made of any biocompatible material that is sufficiently rigid to act as a stable base for the patch, yet flexible enough so that, when the patch is resting thereon, it can be rolled into a cylinder of small enough outer diameter to fit within 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.

[0070] 9A-9D, which illustrate one non-limiting embodiment 7000 of the present invention, in which the frame includes a thin, solid base 700. As shown in FIG. 9A, a roller 710 is disposed on one side of the base. In preferred embodiments of the present invention, the base includes a recess 720 within which the roller sits. In preferred embodiments of the present invention, the roller includes a head 730 having a diameter of less than 5 mm, a close-up of which is shown in FIG. 9B. The roller can be attached to the patch via, for example, a tab or clip. The patch is placed adhesive-side up on the base, and then the patch is rolled around the roller to form a cylinder of small enough outer diameter to fit within a tubular member designed for use in minimally invasive surgery (e.g., a trocar with an inner diameter of 5 mm), as shown in FIG. 9C. In some preferred embodiments of the present invention, the base includes a pouch of the type shown in FIGS. 7 and 8, which extends over the rolled patch, thereby enclosing the rolled patch for introduction into a patient's body, as shown in FIG. 9D. The assembly is introduced through a tubular member, such as a trocar, as described above. After introduction of the assembly, the pouch (if used) is removed, the assembly is spread using a roller, the patch is deployed onto the target tissue or organ, and in a preferred embodiment of the present invention, the adhesive is activated as disclosed above.

[0071] The inventors emphasize that, although the drawings show an embodiment of the invention in which the frame and patch are essentially rectangular, the drawings are presented solely to enable one skilled in the art to make and use the invention disclosed herein and should in no way be construed as limiting the size or dimensions of the base or patch. The patch may be of any convenient shape, and the frame may be of any shape suitable for delivering the patch and of any suitable size that can be compressed to fit within a tubular member designed for use in minimally invasive surgery, preferably a tubular member featuring an inner diameter of 5 mm.

[0072] It is also within the scope of the present invention to disclose a kit for providing a device for introducing a self-adhesive surgical patch during minimally invasive surgery according to the present invention, along with components that can be used to assemble the device prior to its use.

[0073] Referring now to FIG. 10A, FIG. 10A provides a schematic exploded view of one non-limiting embodiment of a kit (8000) disclosed herein. The kit includes a frame (100), and in the kit embodiment shown in FIG. 10, the kit includes the frame embodiment (5000) shown in FIG. 6. The kit further includes a protective sleeve 800, which serves to protect the hemostatic patch from harmful environmental influences, such as exposure to fluids. In certain non-limiting preferred embodiments of the present invention, the protective sleeve is made of polyurethane. A thread or fiber 810 is attached to one end of the protective sleeve, and the thread or fiber is used to pull the protective sleeve from the patient's body once the patch is deployed. In certain non-limiting preferred embodiments of the present invention, the thread or fiber is made of polyester. The kit also includes a suture holder 820 that holds the thread within the package. The suture holder does not contact the patient's body, and in certain non-limiting preferred embodiments of the present invention, the suture holder is made of polyethylene terephthalate glycol (PETG). The kit further includes an auxiliary tube 830 used to assist in winding the protective sleeve 800. In certain non-limiting preferred embodiments of the present invention, the auxiliary tube is made of polyether block amide, commercially available under trade names such as PEBAX and VESTAMID E. While the exploded view shown in FIG. 10A shows the auxiliary tube separated from the protective sleeve, in preferred embodiments of the present invention, the kit includes the auxiliary tube inserted into the protective sleeve. Finally, the kit includes a tray 840, which includes recesses sized and shaped to allow other components of the kit to rest securely therein. These recesses can be manufactured by any technique known in the art, such as molding. The tray does not contact the patient's body. In preferred embodiments of the present invention, the tray is made of PETG, but can be made of any suitable material. In some embodiments, the kit includes a lid that fits snugly onto the tray (the lid is not shown in FIG. 10A). In preferred, non-limiting embodiments, the lid is made of PETG.

[0074] 10B, which schematically illustrates one embodiment of a kit in a tray 840 as provided to a user. Once the kit components are placed in the tray, the tray is sealed with medical-grade breathable paper, preferably made of nonwoven HDPE fibers, such as paper sold under the trade name TYVEK 1073B. The paper is designed to be peeled off the tray immediately prior to use of the kit components. In a preferred embodiment of the present invention, the kit is sealed in a 10-ml container, preferably in accordance with ISO 11137-2:2013, optionally in conjunction with ISO 13004:2022, before being provided to a user. -6 Sterilized by gamma irradiation to a sterility assurance level of 1.

[0075] Reference is now made to Figure 11, which illustrates the use of the kit shown in Figure 10 to introduce a hemostatic patch into a 5mm inner diameter trocar. The illustration in Figure 11 is intended to aid one of ordinary skill in making and using the invention disclosed herein and is not intended to be limiting in any way.

[0076] FIG. 11A shows one example of a kit that appears after the seal is removed, with the kit components in matching recesses in the tray. In the example shown in FIG. 11, the frame of the example (5000) shown in FIG. 6 is used. A hemostatic patch is placed on the lower portion of the frame (e.g., by using dry tweezers), and the frame is then closed and locked into its closed jaw configuration, holding the patch in place, as shown in FIG. 11B. The frame is then folded into its closed configuration by pulling tab 120, thereby rolling the patch with the side that engages the patient's tissue on the inside of the roll. The frame is then inserted into protective sleeve 800 using auxiliary tube 830 (FIG. 11C). Once the frame with the rolled film is placed in the protective sleeve, the auxiliary tube is removed and discarded, as shown in FIG. 11D. As shown in FIG. 11E, the frame (still within the protective sleeve) is then inserted into the tubular member; in the illustrated embodiment, the protective sleeve and frame are inserted into a standard 5 mm inner diameter trocar. The frame, still within the sleeve, is then pushed through the trocar using any suitable device known in the art, such as an endoscope or grasper (FIG. 11F). Once the frame is in place, the protective sleeve is removed by pulling on the thread or fiber 810, as shown in FIG. 11G. Once the protective sleeve is removed, the frame opens toward its open configuration, and the patch is held in place as shown in FIG. 11H, ready for application to the desired tissue. Once the patch is placed on the tissue and held in place long enough for hemostasis to occur, the frame is detached 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-adhesive surgical patch during minimally invasive surgery, the device comprising a flexible base, the base being sufficiently flexible and comprising a member of sufficiently small dimensions such that the base can be compressed to a size small enough to be inserted into a tubular member designed for use in minimally invasive surgery.

2. 10. The device of claim 1, wherein the base comprises a frame (100) that is normally in an essentially planar open configuration of sufficient dimensions to support the surgical patch, the frame compressing upon application of pressure in the plane to a linear closed configuration of sufficiently small dimensions to be insertable into a tubular member designed for use in minimally invasive surgery, and at least partially reopening to the open configuration upon release of the pressure.

3. The frame is a substantially rectangular cross-section characterized by sides no longer than 2.5 mm; a substantially circular cross-section characterized by a diameter of 2.5 mm or less; a substantially elliptical or oval cross-section characterized by a major axis of 2.5 mm or less; a substantially polygonal n-sided cross section (n≠4); Any combination of the above 3. The device of claim 2, comprising a side having a cross-sectional shape and size selected from the group consisting of:

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

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

6. The device of claim 1 , wherein the tubular member is selected from the group consisting of a cannula, a trocar, and a tube.

7. The frame is two flexible points or regions (130) facing each other, which fold outward to form an acute angle upon application of said pressure essentially perpendicular to a line connecting said two flexible points or regions; a corner portion (110) that is sufficiently flexible to expand outwardly into an essentially straight configuration upon application of said pressure; The device of claim 2 , comprising:

8. the flexible points or areas comprise two opposing points or areas of the frame, the two opposing points or areas of the frame being thin relative to the remainder of the frame, thereby imparting flexibility to the frame; and Two opposing points or areas of the frame are angled outward to facilitate outward bending under pressure applied in a direction generally perpendicular to a line connecting the two opposing points or areas. The device of claim 2 , wherein at least one of the following applies:

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

10. The device of claim 9, wherein the frame comprises a plurality of pins (140) extending from the plane of the frame.

11. 10. The device of claim 9, wherein the frame comprises a plurality of holders (360) pivotally mounted to the frame, each of the holders comprising a leg and a head extending essentially horizontally from the leg.

12. The device of claim 2 , wherein the frame includes at least one tab or handle (120) extending outwardly from the frame.

13. The frame (100) a lower portion (500); an upper portion (510) of substantially the same shape and size as said lower portion; a hinge element (520) providing a hinge connection between the lower portion and the upper portion, such that by rotating about the hinge connection, the frame is in a closed jaw configuration in which the lower portion is positioned above the upper portion and the upper and lower portions are substantially mated with one another; a mechanism for reversibly locking the lower and upper portions together; tongues (560) on two opposite sides of said upper portion; grooves (550) on two opposite sides of the lower portion, the grooves (550) being sized to allow insertion of each tongue into a matching groove and positioned so that each of the tongues engages with a matching groove when the frame is in the closed jaw configuration; The device of claim 2 , comprising:

14. The mechanism for reversibly locking the lower and upper portions together comprises: a plurality of pins (530) located on said lower portion; a plurality of holes (540) located on said upper portion, said holes (540) being large enough in size to allow said pins to pass therethrough and positioned such that said pins engage said holes when said frame is in said closed jaw configuration; The device of claim 13, comprising:

15. 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; The device of claim 14 , wherein the hole intersects with the slot.

16. 14. The device of claim 13, wherein the frame comprises corner portions (110) incorporating recesses.

17. The device of claim 2 , wherein the frame comprises a biocompatible plastic.

18. The device of claim 2 , wherein the frame comprises a biocompatible metal.

19. 3. The device of claim 2, wherein the frame further comprises at least one elongated member (490), the elongated member attached to two opposing sides of the frame and curved out of the plane of the frame.

20. 3. The device of claim 2, further comprising an expandable pouch (600), the pouch being capable of adopting a rolled configuration and an unrolled configuration, and configured to be unrolled to enclose the frame when the frame is in the closed configuration.

21. 21. The device of claim 20, wherein the pouch is attached to the frame.

22. 21. The device of claim 20, wherein the device further encloses a flexible band (610) adapted to roll or tear the pouch when the pouch is in the unfolded configuration.

23. The flexible band comprises: Thread and A ribbon made of a flexible biocompatible elastomer.

23. The device of claim 22, comprising at least one component selected from the group consisting of:

24. 10. The device of claim 1, wherein the base comprises a solid base (700) and a roller (710) attached to the base, the base being sufficiently flexible so as to be compressible to a size small enough to be inserted into a tubular member designed for use in minimally invasive surgery.

25. 25. The device of claim 24, further comprising an expandable pouch (600), the pouch being capable of adopting a rolled configuration and an unrolled configuration, and configured to be unrolled to enclose the frame when the frame is in the closed configuration.

26. 26. The device of claim 25, wherein the pouch is attached to the frame.

27. 25. The device of claim 24, wherein the device further encloses a flexible band (610) adapted to roll or tear the pouch when the pouch is in the unfolded configuration.

28. The flexible band comprises: Thread and A ribbon made of a flexible biocompatible elastomer.

28. The device of claim 27, comprising at least one component selected from the group consisting of:

29. 29. The device of any one of claims 1 to 28, wherein the device is adapted to deploy a self-adhesive hemostatic patch during minimally invasive surgery.

30. 1. A method for applying a self-adhesive surgical patch during minimally invasive surgery, comprising: applying the self-adhesive surgical patch to the frame while the frame is in the open configuration, thereby forming a patch / frame assembly; applying pressure to at least two opposing sides of the patch / frame assembly, thereby deforming the patch / frame assembly into the closed configuration; introducing the patch / frame assembly into a patient's body through a tubular member; reopening the patch / frame assembly to the open configuration; placing the patch on a target tissue or organ; removing the frame from the patch; 29. A device according to any one of claims 1 to 28 for use in a method comprising:

31. 31. The device of 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 at least partially adheres to the target tissue or organ.

32. 21. The step of attaching the self-adhesive patch comprises attaching the self-adhesive patch to the device of claim 20; the step of applying pressure is followed by the step of unfolding the pouch to enclose the patch / frame assembly; 31. The device of claim 30, wherein the step of introducing the patch / frame assembly is followed by the step of rerolling or tearing the pouch, thereby exposing the patch / frame assembly and releasing the pressure.

33. 31. The device of claim 30, wherein the self-adhesive surgical patch is a self-adhesive hemostatic patch.

34. 1. A method for applying a self-adhesive surgical patch during minimally invasive surgery, comprising: placing the self-adhesive patch onto the device, thereby forming a patch / base assembly; rolling the patch / base assembly into a cylinder small enough to be inserted into a tubular member designed for use in minimally invasive surgery; introducing the patch / base assembly into a patient's body through a tubular member; unfolding the patch / base assembly; placing the patch on a target tissue or organ; removing the base from the patch; 29. A device according to any one of claims 24 to 28 for use in a method comprising:

35. 35. The device of 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 at least partially adheres to the target tissue or organ.

36. 26. The step of attaching the self-adhesive patch comprises attaching the self-adhesive patch to the device of claim 25; the step of rolling the patch / base assembly is followed by the step of unfolding the pouch to enclose the patch / base assembly; 35. The device of claim 34, wherein the step of introducing the patch / base assembly is followed by the step of rerolling or tearing the pouch, thereby exposing the patch / base assembly.

37. 37. The device of claim 36, wherein the self-adhesive surgical patch is a self-adhesive hemostatic patch.

38. 1. A method for applying a self-adhesive surgical patch during minimally invasive surgery, comprising: placing the self-adhesive patch on the lower portion such that the self-adhesive patch is positioned over the groove; rotating the upper portion about the hinge member so that the tongue engages the groove, thereby holding the self-adhesive patch in place; locking the frame into a closed jaw configuration using the locking mechanism; applying pressure to the frame, thereby causing the frame to reach a closed position; introducing the frame into the patient's body via a tubular member, thereby relieving the pressure on the frame and returning the frame to an at least partially open configuration; placing the patch on a target tissue or organ; removing the frame from the patch; 14. The device of claim 13 for use in a method comprising:

39. 39. The device of claim 38, wherein the self-adhesive surgical patch is a self-adhesive hemostatic patch.

40. 1. A kit for supplying a device for introducing a self-adhesive surgical patch during minimally invasive surgery, comprising: A device according to any one of claims 1 to 28; a protective sleeve (800) of sufficient size to enclose said frame when said frame is in a closed configuration; a thread (810) attached to said protective sleeve; a suture holder (820) configured to hold the suture prior to use of the device; an auxiliary tube (830) configured to assist in winding up the protective sleeve; a tray (840) configured to hold the device, the protective sleeve, the thread, the suture holder, and the auxiliary tube; A kit comprising:

41. 41. The kit of claim 40, further comprising medical-grade breathable paper that extends over the tray to seal the kit.

42. 41. The kit of claim 40, wherein the kit comprises the device of claim 13.

Images