Wound formation and closure systems and methods for removing excess skin

Abstract

Excess skin removal and wound closure devices, such as eyelid plasty devices and methods, are provided. An exemplary device for resecting excess skin (e.g., eyelid skin) and creating a wound closure includes a base, a lever mechanism coupled to the base via a lever pivot, a locking mechanism, an elongate curved first jaw member in a fixed relationship with the base and having a lower serrated tissue contact surface, and a second jaw member in a fixed relationship with the base and having a lower serrated tissue contact surface. An elongate curved second jaw member is in movable relationship with the base and has an upper serrated tissue contact surface. The upper serrated tissue contact surface of the second jaw member may face the lower serrated tissue contact surface of the first jaw member. The locking mechanism is releasably engageable with the second jaw member. Pivotal actuation of the lever mechanism may cause linear movement of the second jaw member relative to the first jaw member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 336,861, filed on April 29, 2022, the disclosure of which is incorporated herein by reference. Background Art

[0003] The present disclosure relates to systems and methods for forming a wound to remove excess skin and close the wound, and in certain embodiments to devices for performing blepharoplasty and methods of using the devices.

[0004] Blepharoplasty is a surgical procedure to remove excess skin and / or fat from a patient's eyelids. The surgery is performed on patients who have excess eyelid skin and wish to remove it for cosmetic reasons and / or for functional reasons, such as to improve peripheral vision in individuals whose upper eyelids have drooped into the field of vision.

[0005] To treat excess upper eyelid skin, the surgeon may remove a section of skin from the upper eyelid and then sew the edges of the resulting incision together. The surgical procedure is typically performed under local anesthesia and / or intravenous or oral sedation and typically takes one to two hours to perform.

[0006] Good cosmetic and functional results depend on the location of the incisions and the removal of an appropriate amount of excess skin tissue. Symmetry is desirable to achieve a satisfactory result, so surgeons generally attempt to remove a similar amount of tissue from each upper eyelid.

[0007] Conventional blepharoplasty surgery has several drawbacks. 1) The surgery needs to be planned and marked on the patient to ensure that a symmetrical and aesthetically pleasing result will be produced, 2) the surgery may take an hour to perform, 3) the injection of local anesthesia may swell and distort the tissue, 4) there is bleeding that requires cauterization, 5) delicate, time-consuming suturing is required, 6) after the surgery, the patient may have unsightly bruising and swelling that lasts for two to three weeks, 7) the patient must limit activity and place ice on the eyelid for several days, 8) the patient needs to return for suture removal, and 9) the patient may have postoperative complications including wound dehiscence, suture granulomas, and asymmetry.

[0008] Currently available blepharoplasty systems and methods provide good results for patients, however, there is a need for improvements in blepharoplasty techniques. Likewise, currently available devices and methods for removing excess skin and closing wounds provide good results for patients, however, improvements in excess skin removal and wound closure techniques are desired. Embodiments of the present invention may, for example, make such procedures easier and faster for physicians, avoiding the need for intravenous or oral sedation, local anesthesia injections, cauterization, and wound suturing. Such a procedure may be provided at a lower cost and is less invasive and heals faster for the patient, thus addressing some of the deficiencies of current blepharoplasty procedures and current excess skin removal and wound closure procedures. Summary of the invention

[0009] Embodiments of the present invention are directed to systems and methods for removing excess skin and closing wounds, and in certain embodiments, include devices for performing blepharoplasty and methods of using the devices.

[0010] Although embodiments of the present invention are specifically directed to blepharoplasty systems and methods, it should be understood that any aspect, component, feature, or process discussed herein with respect to blepharoplasty may also be incorporated into the exemplary excess skin removal and wound closure systems and methods in a broader sense, and such excess skin removal and wound closure systems and methods are also equally encompassed by the present disclosure.

[0011] Exemplary embodiments include devices for forming and closing upper eyelid wounds and other types of wounds. In some cases, such wounds can be formed using any device and / or method disclosed herein (e.g., using jaws and cutting mechanisms). In some cases, such wounds can have various sizes and shapes. In some cases, such wounds can be on different areas of the patient's body. For example, exemplary systems and methods can be used to remove excess skin and close wounds in sagging chin areas, sagging forehead areas, sagging chest areas, sagging underarm areas, etc. In some cases, exemplary devices for closing such wounds may include jaws and cutting devices to form and zipper seal such wounds using any of the embodiments disclosed herein. In some cases, exemplary devices may be embodied in various sizes, shapes, and / or curvatures to fit into or engage with these various areas of the body. In some cases, exemplary wound closure systems and methods can be used to close traumatic wounds in the following manner: the edges of the wounds are brought together and sealed with jaws to remove the tension of the traumatic wounds so that they can be effectively closed with tissue glue instead of sutures. For such applications, devices of various sizes and curvatures may be used, optionally in conjunction with a set of adjustable jaws to accommodate wounds of variable sizes.

[0012] Blepharoplasty is a common procedure performed in a surgical operating room or outpatient setting (office). The surgeon may typically spend 1-2 hours to perform the procedure, using IV or oral sedation and injected local anesthetics, and requiring the use of cautery and suturing. The patient may experience significant postoperative bruising, swelling, and disfigurement that typically lasts 2-3 weeks. The patient must return to have the sutures removed, and may have complications including wound dehiscence, suture granulomas, and asymmetry. The exemplary blepharoplasty systems and methods disclosed herein may enable the surgeon to complete the procedure in less than an hour, at significantly lower cost, may be completed in an outpatient setting without the need for IV or oral sedation or injected local anesthesia, cautery, or suturing, resulting in a faster recovery for the patient and with less bruising and swelling than the current standard of care.

[0013] Embodiments of the present invention include excess skin removal and wound closure systems, including but not limited to blepharoplasty systems, having (1) a skin marking pen with a ruler, (2) an antiseptic, (3) a local anesthetic, (4) a grasping tool having an elongated surface contact area and serrations to pull and prepare skin tissue for clamping and cutting off blood flow to the tissue desired to be removed, (5) an eyelid lifting device having serrations and a ratchet mechanism or a latch mechanism that compresses and seals excess skin, (6) a cutting mechanism to excise unwanted skin, and (7) an adhesive to close the incision. In some cases, the ratchet mechanism or latch mechanism may be referred to as a locking mechanism. In some cases, the locking mechanism may be operable to lock the device in a closed position. Exemplary excess skin removal and wound closure system devices, including but not limited to blepharoplasty system devices, may have serrations that clamp the skin and form a desired skin configuration for cutting. Embodiments disclosed herein include redundant skin removal and wound closure systems, including but not limited to blepharoplasty systems, which have cutting mechanisms that can be attached to blepharoplasty or other redundant skin removal and wound closure devices that provide removal of redundant skin tissue. Exemplary redundant skin removal and wound closure systems including but not limited to blepharoplasty systems include lever mechanisms to allow jaws to be actuated at various distances and to allow adjustment of skin tissue objects for removal. In some cases, redundant skin removal and wound closure systems including but not limited to blepharoplasty systems may include ratchet mechanisms that allow actuation jaws to be locked at various distances and allow adjustment of skin tissue objects for removal. Embodiments disclosed herein include redundant skin removal and wound closure systems, including but not limited to blepharoplasty systems, which have marking components, local anesthetics, iodine swabs, and incision adhesives to allow surgery to be completed quickly (e.g., within 10 minutes) after anesthesia is completed. Incision adhesives may be included in redundant skin removal and wound closure systems (including but not limited to blepharoplasty systems) to provide sealing of incisions. An exemplary excess skin removal and wound closure system including but not limited to a blepharoplasty system may include a gripping tool with serrations to enhance manipulation of tissue. The gripping tool may have an elongated body and a narrow portion for fitting through an excess skin removal and wound closure device (including but not limited to a blepharoplasty device) from a forward direction and deploying to grab or grasp and pull tissue through. An exemplary excess skin removal and wound closure system including but not limited to a blepharoplasty system includes a kit to complete the entire procedure.

[0014] In a first aspect, embodiments of the present invention include a device for excising excess skin and forming wound closure. An exemplary device may include a base, a lever mechanism coupled to the base, a locking mechanism, a first jaw member having an elongated curved shape with a fixed relationship to the base and having a lower tissue contact surface, and a second jaw member having an elongated curved shape with a movable relationship to the base and having an upper tissue contact surface, wherein the upper tissue contact surface of the second jaw member faces the lower tissue contact surface of the first jaw member. The pivoting actuation of the lever mechanism may cause the movement of the second jaw member relative to the first jaw member. The locking mechanism may be configured to keep the first jaw member and the second jaw member in a fixed relationship relative to each other. In some cases, the lower tissue contact surface is serrated, and the upper tissue contact surface is serrated. In some cases, the lever mechanism is coupled to the base via a lever pivot. In some cases, the pivoting actuation of the lever mechanism causes the linear movement of the second jaw member relative to the first jaw member. In some cases, the locking mechanism is releasably engaged with the second jaw member. In some cases, the locking mechanism is coupled to the base via a locking pivot. In some cases, the device also includes a latch mechanism, and the locking mechanism is releasably engaged with the latch mechanism. In some cases, the locking mechanism is releasably engaged with the latch mechanism at a position within the base. In some cases, the latch mechanism is connected to the second jaw member. In some cases, the device includes a latch spring that can be compressed between the latch mechanism and the base. In some cases, the latch spring biases the engagement of the latch mechanism against the locking mechanism. In some cases, the locking mechanism is connected to a lever mechanism. In some cases, the device includes a pawl in a fixed relationship with the second jaw member, wherein the locking mechanism includes an engagement tooth configured to releasably engage the pawl. In some cases, the device includes a locking spring configured to bias the engagement tooth of the locking mechanism against the pawl. In some cases, at least one of the first jaw member or the second jaw member includes a silicone coating. In some cases, the device includes an actuating jaw spring configured to bias the second jaw member away from the first jaw member. In some cases, the device includes a lever-actuated torsion spring configured to bias the second jaw member away from the first jaw member. In some cases, at least one of the first jaw member or the second jaw member includes a tissue-contacting side having a contoured surface having a shape customized to the patient's anatomy based on an imaging scan of the patient.

[0015] On the other hand, embodiments of the present invention include a skin removal and wound closure device, which includes a base, a lever mechanism connected to the base via a lever pivot, a locking mechanism, a first elongated curved jaw member fixedly related to the base and having a lower serrated tissue contact surface, and a second elongated curved jaw member pivotally related to the lever and having an upper serrated tissue contact surface, wherein the upper serrated tissue contact surface faces the lower serrated tissue contact surface of the first jaw member. The locking mechanism can be releasably engaged with a support assembly of the first jaw member. The pivotal actuation of the lever mechanism can cause the second jaw member to move linearly relative to the first jaw member. In some cases, the locking mechanism includes a first set of engaging teeth and a second set of engaging teeth that can releasably engage the support assembly of the first jaw member. In some cases, the locking mechanism includes a helical portion that can compress the locking mechanism. In some cases, the device includes a jaw actuation handle spring connected to the base and the lever mechanism. In some cases, the support assembly of the first jaw member is releasably engaged with the base. In some cases, the locking mechanism includes one or more locking mechanism compression tabs.

[0016] On the other hand, embodiments of the present invention include a method for performing a redundant skin removal and wound closure procedure. An exemplary method may include grasping a patient's tissue with a grasping tool, positioning the tissue between an upper jaw mechanism and a lower jaw mechanism of a redundant skin removal and wound closure device, pivoting a lever of the redundant skin removal and wound closure device relative to a base of the redundant skin removal and wound closure device so as to cause the lower jaw mechanism to advance toward the upper jaw mechanism, thereby clamping the tissue therebetween, forming an incision in the tissue, and removing a portion of the tissue from the patient. In some cases, the pivoting of the lever of the redundant skin removal and wound closure device relative to the base of the redundant skin removal and wound closure device causes the linear advancement of the lower jaw mechanism toward the upper jaw mechanism. In some cases, a method may include applying an adhesive to the incision. In some cases, a method may include inserting a grasping tool between the upper jaw mechanism and the lower jaw mechanism of the redundant skin removal and wound closure device before grasping the tissue with the grasping tool. In some cases, the positioning step may include removing a gripping tool from between an upper jaw mechanism and a lower jaw mechanism of the excess skin removal and wound closure device. In some cases, when the lever pivots relative to the base, the lever pivots relative to a support assembly of the upper jaw mechanism. In some cases, when the lever pivots relative to the base, the lever slides relative to a support assembly of the upper jaw mechanism. In some cases, a method may include locking the lower jaw mechanism in place relative to the upper jaw mechanism before forming an incision. In some cases, the locking step includes pivoting a locking mechanism of the excess skin removal and wound closure device. In some cases, the locking step includes compressing the locking mechanism of the excess skin removal and wound closure device. In some cases, the gripping tool includes a distal end having a microneedle.

[0017] On the other hand, embodiments of the present invention include a blepharoplasty device that can be used to remove excess eyelid skin tissue from the eyelid of a patient. An exemplary blepharoplasty device may include a base, a lever mechanism connected to the base via a lever pivot, and a locking mechanism. The device may also include a first jaw member that is fixed in relationship to the base and has a lower serrated tissue contact surface, and a second jaw member that is slender and curved in a movable relationship with the base and has an upper serrated tissue contact surface. The upper serrated tissue contact surface of the first jaw member may face the lower serrated tissue contact surface of the second jaw member. The locking mechanism may be releasably engaged with the second jaw member. The pivotal actuation of the lever mechanism may cause the second jaw member to move linearly relative to the first jaw member. In some cases, the second jaw member includes a shielding limiting movement of the cutting mechanism perpendicular to the actuation path. In some cases, the locking mechanism is connected to the base via a locking pivot. In some cases, the device may include a pawl that is fixed in relationship to the second jaw member. The locking mechanism may include an engaging tooth that is configured to releasably engage the pawl. In some cases, the device may include a locking spring configured to bias an engagement tooth of the locking mechanism against the pawl. In some cases, the device may include an actuating jaw spring configured to bias the second jaw member away from the first jaw member. In some cases, the device may include a torsion spring configured to adjust the lever mechanism to bias the second jaw member away from the first jaw member.

[0018] In another aspect, embodiments of the present invention include a blepharoplasty device having a base, a lever mechanism coupled to the base via a lever pivot, a locking mechanism, a first elongated curved jaw member in a fixed relationship with the base and having a lower serrated tissue contact surface, and a second elongated curved jaw member in a pivotal relationship with the lever and having an upper serrated tissue contact surface. The upper serrated tissue contact surface of the second jaw member may face the lower serrated tissue contact surface of the first jaw member. The locking mechanism may be releasably engaged with a support assembly of the first jaw member. In some cases, the locking mechanism may be releasably engaged with the lever mechanism. Pivotal actuation of the lever mechanism may cause linear movement of the second jaw member relative to the first jaw member. In some cases, the locking mechanism includes a first set of engaging teeth and a second set of engaging teeth that can releasably engage the support assembly of the first jaw member. In some cases, the locking mechanism includes a helical portion that can compress the locking mechanism. In some cases, the locking mechanism includes an engaging latch that can releasably engage the lever mechanism. In some cases, the device includes a jaw actuation handle spring coupled to the base and the lever mechanism. In some cases, the support assembly of the first jaw member is releasably engaged with the base. In some cases, the locking mechanism includes one or more locking mechanism compression tabs.

[0019] On the other hand, embodiments of the present invention provide methods for performing blepharoplasty. An exemplary method may include grasping the eyelid tissue of the patient with a grasping tool, positioning the eyelid tissue between the upper jaw mechanism and the lower jaw mechanism of the blepharoplasty device, pivoting the lever of the blepharoplasty device relative to the base of the blepharoplasty device so as to cause the linear advancement of the lower jaw mechanism toward the upper jaw mechanism, thereby clamping the eyelid tissue therebetween, forming an incision in the eyelid tissue, and removing a portion of the eyelid tissue from the patient. In some cases, the method may include applying an adhesive to the incision. In some cases, the method may include inserting the grasping tool between the upper jaw mechanism and the lower jaw mechanism of the blepharoplasty device before grasping the eyelid tissue with the grasping tool. In some cases, the positioning step may include removing the grasping tool from between the upper jaw mechanism and the lower jaw mechanism of the blepharoplasty device. In some cases, when the lever is pivoted relative to the base, the lever is pivoted relative to the support assembly of the upper jaw mechanism. In some cases, the lever slides relative to a support assembly of the upper jaw mechanism as the lever pivots relative to the base. In some cases, the method may include locking the lower jaw mechanism in place relative to the upper jaw mechanism prior to forming the incision. In some cases, the locking step may include pivoting a locking mechanism of the blepharoplasty device. In some cases, the locking step may include compressing a locking mechanism of the blepharoplasty device.

[0020] In some embodiments, the blepharoplasty device may include silicone coated jaws. The presence of silicone may be used to reduce the ability of the jaws to adhere to the skin, thereby allowing the ability to seal the incision with an adhesive when the skin is clamped within the jaws.

[0021] These and other embodiments are described in more detail below in the description of the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Specific embodiments of the disclosed devices, surgical systems or methods will now be described with reference to the accompanying drawings.Nothing in this detailed description is intended to suggest that any particular component, feature or step is essential to the invention.

[0023] Figure 1A and Figure 1B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0024] Figure 2A and Figure 2B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0025] Figure 3A and Figure 3BAspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0026] Figure 4A and Figure 4B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0027] FIG. 5A to FIG. 5D Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0028] FIG. 6A to FIG. 6I Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0029] Fig. 7A and Figure 7B Various aspects of a gripping tool according to some embodiments of the invention are shown.

[0030] Fig. 8A and Figure 8B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0031] Fig.9A and Fig. 9B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0032] Fig. 10A and Fig. 10B Aspects of an excess skin removal and wound closure device with a removable jaw mechanism according to some embodiments of the present invention are shown.

[0033] FIG. 11A to FIG. 11D Aspects of a removable jaw mechanism according to some embodiments of the present invention are shown.

[0034] FIG. 12A to FIG. 12E Various aspects of a removable jaw mechanism according to some embodiments of the present invention are shown.

[0035] FIG. 13A to FIG. 13D Aspects of an attachable cutting mechanism according to some embodiments of the present invention are shown.

[0036] FIG. 14A to FIG. 14D Aspects of an attachable cutting mechanism according to some embodiments of the present invention are shown.

[0037] Fig.15A and Fig. 15B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0038] Fig.16A and Fig. 16B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0039] Fig.17A and Fig. 17B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0040] 18A to 18C Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0041] Fig.19A and Fig.19B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0042] FIG. 20A to FIG. 20C Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0043] FIG. 21A to FIG. 21C Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown.

[0044] Fig.22A and Fig. 22B Various aspects of a gripping tool according to some embodiments of the invention are shown.

[0045] FIG. 22C to FIG. 22E Various aspects of a gripping tool according to some embodiments of the invention are shown.

[0046] Fig.23A and Fig. 23B Aspects of an excess skin removal and wound closure device according to some embodiments of the present invention are shown. DETAILED DESCRIPTION

[0047] Various embodiments of blepharoplasty devices and methods of use thereof are disclosed herein. The following description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Various changes may be made to the described embodiments in terms of the function and arrangement of elements described herein without departing from the scope of the invention.

[0048] As used in this application and in the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including". Furthermore, the term "coupled" generally means electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked, and does not exclude the presence of intermediate elements between coupled or associated items in the absence of specific language to the contrary. As used herein, the term "upper" means toward the top of the patient's head, and "lower" means toward the patient's feet.

[0049] Although the operations of the exemplary embodiments of the disclosed methods may be described in a particular order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the particular order disclosed. For example, the operations described in the order may be rearranged or performed simultaneously in some cases. In addition, the descriptions and disclosures provided in association with a particular embodiment are not limited to that embodiment and may apply to any disclosed embodiment.

[0050] The devices and methods disclosed herein may generally improve the overall efficacy of blepharoplasty surgery by simplifying the steps required to perform a blepharoplasty procedure, enhancing consistency of the procedure, and / or promoting faster healing and less trauma to the patient following surgery.

[0051] Blepharoplasty is a common plastic surgery procedure performed in a surgical operating room, but some procedures can be performed in an outpatient setting (office). The surgeon may typically spend 1-2 hours to perform the procedure, which increases costs compared to an outpatient setting. The postoperative period from a procedure in a surgical operating room may take 2-3 weeks, with unsightly bruising and swelling. The exemplary blepharoplasty systems and methods disclosed herein may enable the surgeon to complete the procedure in less than an hour, at a significantly lower cost, can be completed in an outpatient setting, and involve a faster recovery and less bruising and swelling than the current standard of care.

[0052] An exemplary blepharoplasty procedure disclosed herein may involve marking the area of ​​eyelid tissue desired to be removed with a marking pen and providing a local anesthetic to temporarily anesthetize the surgical area. After the surgical area is fully anesthetized, the surgical site can be disinfected with an iodine swab. A grasping tool (e.g., tweezers) can enter through the open jaws of the device, compress into a closed position, grasp the marked eyelid skin tissue area, and then pull the tissue through the open jaws of the device. Then, one of the device jaws can be actuated to a closed position, thereby completely clamping the tissue and cutting off blood flow. The eyelid skin tissue can then be removed using a cutting mechanism. In some cases, the cutting mechanism is integrated with the blepharoplasty device. In some cases, the cutting mechanism can be a separate device used after the skin tissue is clamped by the blepharoplasty device. After removing excess tissue, an incision adhesive can be applied to the incision to seal the incision and allow it to heal.

[0053] Now turning to the attached figure, Figure 1A and Figure 1B One embodiment of a blepharoplasty device 100 is shown that is configured to capture eyelid tissue to facilitate removal of tissue from a portion of the eyelid. The device 100 is a tissue gripping device (e.g., a clamp) that includes a pair of elongated jaw members 102, 104 that are operably connected together so that they can be moved relative to each other in an open position ( Figure 1A ) and closed position ( Figure 1B ). Upper jaw member 102 and lower jaw member 104 can bend to follow the contour of the eyelid area to produce a desired incision shape. In some embodiments, the jaw members can have an upper and lower curve with a radius of 1 3 / 8 inches and an anterior and posterior curve with a radius of 1 5 / 8 inches to create the contour. Fig.16A and Fig. 16B , jaw member 1502 (or its tissue contacting surface 1506) has an upper and lower curve 1507 (dashed line). In some embodiments, the upper and lower curves correspond to the arch 1507, which is within the plane of the drawing and rises in the center and lowers on each side, for example, as opposed to a curve relative to (perpendicular to) the plane of the drawing, where the center is farther away from the observer and each side is closer to the observer. Fig.21A , jaw member 2102 (or its tissue contacting surface) has an anterior-posterior curve 2107 (dashed line). In some embodiments, the anterior-posterior curve corresponds to this arch 2107, which is in the plane of the drawing and lowers in the center and rises on each side, such as the opposite of a curve relative to (perpendicular to) the plane of the drawing, where the center is closer to the observer and each side is farther away from the observer. In some cases, the contour formed is established by imaging of the patient's anatomy using photographs, computed tomography (CT) scans, or data or information from other imaging devices.

[0054] In some embodiments, due to their relative positions relative to the head and foot, the upper jaw member will be considered an upper jaw member and the lower jaw member will be considered a lower jaw member. For simplicity, the terms "upper" and "lower" are used herein to refer to the upper member and the lower member, but it should be understood that "upper" and "lower" do not imply any positional relationship other than anatomical reference points of the body.

[0055] Upper jaw member 102 has a first tissue contacting surface 106, and lower jaw member 104 has a second tissue contacting surface 108. First tissue contacting surface 106 and second tissue contacting surface 108 generally face each other in an opposing manner such that when eyelid tissue is positioned between upper jaw member 102 and lower jaw member 104, first tissue contacting surface 106 and second tissue contacting surface 108 may move toward each other to capture and secure the eyelid tissue therebetween.

[0056] When upper jaw member 102 and lower jaw member 104 are in the open position ( Figure 1A ), first tissue contact surface 106 and second tissue contact surface 108 are separated by a certain distance to form an opening or space large enough to receive eyelid tissue. When upper jaw member 102 and lower jaw member 104 are moved together to a closed position ( Figure 1B ), the distance between the first contact surface 106 and the second contact surface 108 is reduced to a smaller distance. Due to the smaller distance, the opening or space between the first tissue contact surface 106 and the second tissue contact surface 108 is small enough to capture and fix any eyelid tissue positioned between the first tissue contact surface 106 and the second tissue contact surface 108.

[0057] The first tissue contacting surface 106 and the second tissue contacting surface 108 are configured to clamp and hold eyelid tissue positioned between the opposing first tissue contacting surface 106 and the second tissue contacting surface 108. The device 100 also includes a cutting member or cutting mechanism slide 160. The cutting mechanism slide 160 may include a cutting blade (not shown) or be coupled to a cutting blade, and the blade may be movable along a blade guide 144 and / or within the blade guide. As shown here, the blade guide 144 may be a curved slit, track, or edge along the upper jaw 102. Advantageously, as further discussed herein, such a cutting mechanism may be actuated through skin tissue in a medial to lateral direction to remove a desired amount of skin tissue. In some embodiments, the lower jaw member 104 may be referred to as an actuating jaw. As shown in FIG. Figure 1A and Figure 1BAs shown, the actuating jaw 104 may include a tissue contacting side 105. The device 100 may also include an actuating jaw lever 120 and a locking mechanism 130 such as a ratchet mechanism post. Embodiments of the present invention include devices with ratchet mechanisms to allow the actuating jaws to be locked at various distances and to allow adjustment of the skin tissue object for removal. In some cases, the locking mechanism may be attached to the actuating handle component of the device.

[0058] Thus, embodiments of the present invention provide unique blepharoplasty systems, including related devices, kits, and methods for removing eyelid skin tissue and sealing incised skin. An exemplary device may include two curved serrated skin contacting jaws, one of which is fixed (e.g., upper member 102) and one of which is actuated (e.g., lower member 104), whereby the configuration of the device may be in a closed position (e.g., Figure 1B ) and the open position (e.g. Figure 1A ), wherein the open position allows eyelid skin tissue to protrude between the jaws, and the closed position clamps the skin tissue, thereby restricting blood flow to the eyelid skin tissue. The actuation mechanism may include a lever 120 having a pivot 122, whereby actuation of the actuation jaw lever 120 about the pivot 122 enables adjustment of the linear position of the actuation jaw 104 relative to the fixed jaw 102 (e.g., between Figure 1A The open configuration shown is similar to Figure 1B Between the closed configurations shown, in the open configuration, the lever 120 is in an upward position, and in the closed configuration, the lever is in a downward position).

[0059] In some cases, the actuating jaw 104 may be releasably coupled to a ratchet mechanism 130, thereby allowing the distance between the jaws 102, 104 to be locked in various distances between fully open (e.g., 8 mm) and fully closed (e.g., 0 mm). The ratchet mechanism 130 may include a mechanism to release the coupling of the ratchet mechanism to allow readjustment of the operating jaw 104. As further discussed elsewhere herein, in some embodiments, the device may include a cutting attachment or be configured to operate in association with a cutting attachment, and the cutting attachment may include an actuation mechanism to cut the clamped eyelid skin tissue.

[0060] In some embodiments, the blepharoplasty device may include silicone coated jaws (e.g., jaws 102, 104). The presence of silicone can be used to reduce the ability of adhesive to adhere to the jaws of the device, thereby allowing the ability to seal the incision with adhesive when the skin is clamped within the jaws.

[0061] Figure 2A and Figure 2B Provided in an open position or configuration ( Figure 2A ) and in a closed position or configuration ( Figure 2B) with the upper jaw 102 and the lower jaw 104 further apart in an open position or configuration and the upper jaw 102 and the lower jaw 104 closer together in a closed position or configuration. Alternating between the open configuration and the closed configuration may involve linear movement of the lower jaw 104 relative to the upper jaw 102, as shown by arrow A. The first contact surface 106 and the second contact surface 108 may have serrated edges. Thus, embodiments of the present invention include devices having jaws with serrations to allow the clamped skin to be squeezed onto itself to form a desired location for cutting. The serrations may be interlocking, allowing the skin tissue to be deformed to such an extent that the desired amount of skin for removal remains protruding and the skin remains squeezed after the clamp is released.

[0062] Figure 3A and Figure 3B Provided in a closed position or configuration ( Figure 3A ) and in the open position or configuration ( Figure 3B ) shows an additional view of the device 100, in which the upper jaw 102 and the lower jaw 104 are closer together in the closed position or configuration, and in the open position or configuration, the upper jaw 102 and the lower jaw 104 are further apart. The device 100 may include an actuating jaw lever 120 and a locking mechanism 130 such as a ratchet mechanism post. The pivot 122 enables the actuating jaw lever 120 to pivot relative to the base 180 of the device 100.

[0063] Figure 4A and Figure 4B Provided in a closed position or configuration ( Figure 4A ) and in the open position or configuration ( Figure 4B ) shows an additional view of the device 100, in which the upper jaw 102 and the lower jaw 104 are closer together in the closed position or configuration, and in the open position or configuration, the upper jaw 102 and the lower jaw 104 are farther apart. The device 100 may include an actuating jaw lever 120 and a locking mechanism 130 such as a ratchet mechanism post 131. As shown here, the locking mechanism may include a locking spring 132, a gear 134, and a pivot 136. The gear 134 is configured to engage a pawl 138. In Figure 4B In the embodiment, the actuating jaw lever 120 is raised or actuated, the actuating jaw spring 142 is expanded, the locking spring 132 is compressed, and the pawl 138 is positioned lower (relative to the Figure 4A 13), the gear 134 of the locking or ratcheting mechanism 130 is not engaged with the pawl 138, and the locking (ratchet) mechanism 130 is released. Figure 4A , the locking (ratchet) mechanism 130 is engaged.

[0064] Thus, the device 100 may have a ratchet mechanism 130 that includes an elongated post 131 that rotates about a pivot 136. The post or elongated body 131 may include serrations, teeth, gears, etc. that are coupled to the device actuation jaw 104 (or to the actuation jaw extension 104A). For example, rotation or pivoting of the post 131 about the pivot 136 may allow engagement and disengagement of the post teeth 134 with the pawl 138 of the actuation jaw 104 (or the lower jaw extension 104A) so as to enable the jaws 102, 104 to be locked in place relative to each other in a configuration with a varying distance between the jaws so as to enable adjustment of the subject distance between the jaws. The ratchet mechanism post 131 may be spring loaded (e.g., via a locking spring 132) to be biased or naturally rotated into a locked position and also allowed to rotate into a disengaged position.

[0065] In some embodiments, the device actuation jaw 104 can be loaded with a compression spring 142 in the direction of linear motion. In some embodiments, the device handle or lever 120 can be spring loaded (e.g., via spring 142) into an open position, thereby allowing the actuation jaw to be manually compressed (e.g., by actuating the lever 120 in the direction indicated by arrow B) into a closed position. The handle or lever 120 can be coupled to a lifting mechanism to actuate the actuation jaw 104 from the open position to the closed position. Thus, as shown here, when the proximal portion 133 of the column 131 moves as indicated by arrow A, the spring 132 is compressed, the tooth 134 becomes disengaged from the pawl 138, and the spring 142 can then push the lower jaw 104 in a downward direction (e.g., by pressing the lower jaw extension 104A downward). The movement of the lever 120 in the direction indicated by arrow B can cause the lower jaw 104 to move upward toward the upper jaw 102, and can cause compression of the spring 142.

[0066] Figure 5A and Figure 5B Provided in an open position or configuration ( Figure 5A ) and in a closed position or configuration ( Figure 5B ) are additional views of the device 100 with the upper jaw 102 and the lower jaw 104 being further apart in an open position or configuration and closer together in a closed position or configuration. As shown, the device 100 includes an actuation jaw lever pivot 122 about which the actuation jaw lever 120 can pivot relative to the base 180 and an actuation jaw guide post 124. Thus, in contrast to devices that include a movable handle and a fixed handle that move in a linear motion, embodiments of the present invention include a device having a pivot feature 122 to provide a lever 120 for actuating the adjustable jaw 104. Advantageously, the exemplary blepharoplasty system device uses pivot rotation (e.g., about the pivot 122) to establish linear adjustment between two surface contacting jaws, and uses pivot rotation (e.g., about the Figure 4A The pivot 136 shown in the figure can be used to establish a releasable lock between the two jaws. Figure 5C As shown, a portion of the eyelid tissue T can be clamped between the upper jaw 102 and the lower jaw 104. Figure 5D As shown, the eyelid tissue can then be removed.

[0067] 6A to 6F Various illustrations of a blepharoplasty device 100 according to an embodiment of the present invention are provided. As shown here, the device 100 can include a cutting mechanism 140 having a cutting member or blade 142. The cutting member 142 has a cutting edge 143. The cutting mechanism 140 can be a sliding cutting mechanism and can slide from one side of the device to an opposite side of the device, such as in the direction indicated by arrow A. As shown here, the blade 142 can slide along or within a blade guide 144 of the upper jaw 102. FIG. 6G to FIG. 6I It is shown how the eyelid tissue T is removed via the operation of the cutting mechanism.

[0068] Fig. 7A and Figure 7B Shown in an open position or configuration ( Fig. 7A ) and in a closed position or configuration ( Figure 7B ) various aspects of a grasping tool or tweezers 200. The grasping tool 200 may include skin contact serrations 210.

[0069] The elongated end (e.g., 205) of the forceps or grasping tool can have various curvatures, widths, and lengths. In some embodiments, the distal end (e.g., 206) of the forceps or grasping tool can be curved to conform to the intended tissue object for manipulation, and relatedly, the distal end of the grasping tool can include any curved feature portion corresponding to the jaw member of the device disclosed herein (e.g., as described in reference Figure 1A , Figure 1B , Fig.16A and Fig. 16B The present disclosure also contemplates tissue-contacting distal ends (e.g., 206) of various lengths and widths that can be configured to grip a surface area of ​​tissue. Fig.22A and Fig. 22B The grasping tool or forceps 2200 shown and / or Fig. 22C and Fig.22D The illustrated grasping tool or forceps 2200A may similarly have elongated ends of various curvatures, widths, and lengths. Likewise, the distal end of the forceps or grasping tool (2200 or 2200A) may be curved to conform to the intended tissue object for manipulation, and relatedly, the distal end of the grasping tool may include any curved feature portion corresponding to the jaw member of the device disclosed herein (e.g., as described in reference Figure 1A , Figure 1B , Fig.16A and Fig. 16B The present disclosure also contemplates tissue-contacting distal ends of various lengths and widths, including forceps or grasping tools 2200 or 2200A, which can be configured to grasp a surface area of ​​tissue.

[0070] Return to reference Fig. 7A and Figure 7B , the grasping tool can be used (e.g., by a surgeon or operator) to position patient tissue relative to the blepharoplasty device. For example, when the blepharoplasty device is in an open position, a portion of the patient's tissue can be positioned between its upper and lower jaws. The grasping tool 200 can be used to facilitate movement of tissue into the space between the upper and lower jaws. For example, the grasping tool 200 can clamp the patient's upper eyelid tissue and pull it away from the patient and into the space between the upper and lower jaws.

[0071] Embodiments of the present invention may include a kit with a skin grasping tool (e.g., tweezers 200), a local anesthetic, an incision adhesive, a marker pen, and an iodine swab. The grasping tool (e.g., tweezers 200) may have an elongated body divided into two serrated tissue contact surfaces at the distal end. The contact surface may be curved fairly with the anterior-posterior curve of the eyelid skin tissue. The distal end contact surface may be adjusted between two distances of an open position (e.g., 8mm) and a closed position (e.g., 0mm). In some embodiments, the distance between the surfaces can be adjusted manually by compression. The serrations on the contact surface may provide a shear force between the eyelid skin tissue and the grasping tool, thereby allowing the skin tissue to be positioned by the jaws of the device component. The elongated body may include a portion with a reduced width to be assembled through the open jaws of the device component. In operation, the skin grasping tool (e.g., tweezers 200) may be assembled through the device from the forward direction, and unfolded and compressed to grab or grasp and pull the tissue through.

[0072] An exemplary treatment process may include marking the area of ​​eyelid tissue desired to be removed with a marking pen and providing a local anesthetic to temporarily anesthetize the surgical area. After the surgical area is fully anesthetized, the surgical site can be disinfected with an iodine swab. A grasping tool can enter through the open jaws of the device, compress into a closed position, and grab or grasp the marked eyelid skin tissue area, and then pull the tissue through the open jaws of the device. The device can then be completely closed, thereby clamping the tissue and cutting off blood flow. The eyelid skin tissue can then be removed using a cutting mechanism. After removing the tissue, an incision adhesive can be applied to the incision to seal the incision and allow it to heal.

[0073] Thus, embodiments of the present invention include a kit having a skin grasping tool, a marking pen, a local anesthetic, an iodine swab, and an incision adhesive to fully complete a blepharoplasty surgical procedure.

[0074] Fig. 8A and Figure 8B One embodiment of a blepharoplasty device 300 is shown that is configured to capture eyelid tissue to facilitate removal of tissue from a portion of the eyelid. The device 300 is a tissue gripping device (e.g., jaws) that includes a pair of elongated jaw members 302, 304 that are operably connected together so that they can be moved relative to each other in an open position ( Fig. 8A ) and closed position ( Figure 8B ) The upper jaw member 302 and the lower jaw member 304 can be bent to follow the contour of the eyelid area to produce a desired incision shape.

[0075] In some embodiments, due to their relative positions relative to the head and foot, the upper jaw member will be considered an upper jaw member and the lower jaw member will be considered a lower jaw member. For simplicity, the terms "upper" and "lower" are used herein to refer to the upper member and the lower member, but it should be understood that "upper" and "lower" do not imply any positional relationship other than anatomical reference points of the body.

[0076] Upper jaw member 302 has a first tissue contacting surface 306, and lower jaw member 304 has a second tissue contacting surface 308. First tissue contacting surface 306 and second tissue contacting surface 308 generally face each other in an opposing manner such that when eyelid tissue is positioned between upper jaw member 302 and lower jaw member 304, first tissue contacting surface 306 and second tissue contacting surface 308 may move toward each other to capture and secure the eyelid tissue therebetween.

[0077] When upper jaw member 302 and lower jaw member 304 are in the open position ( Fig. 8A ), first tissue contact surface 306 and second tissue contact surface 308 are separated by a certain distance to form an opening or space large enough to receive eyelid tissue. When upper jaw member 302 and lower jaw member 304 are moved together to a closed position ( Figure 8B), the distance between the first contact surface 306 and the second contact surface 308 is reduced to a smaller distance. Due to the smaller distance, the opening or space between the first tissue contact surface 306 and the second tissue contact surface 308 is small enough to capture and secure any eyelid tissue positioned between the first tissue contact surface 306 and the second tissue contact surface 308. As shown here, the first tissue contact surface 306 and the second tissue contact surface 308 may include serrated jaw features or serrations. Therefore, embodiments of the present invention include devices having jaws with serrations to allow the clamped skin to be squeezed onto itself, thereby forming a desired location for cutting. In some embodiments, the upper jaw member 302 may be referred to as a fixed jaw, and the lower jaw member 304 may be referred to as an actuated jaw.

[0078] The first tissue contact surface 306 and the second tissue contact surface 308 are configured to clamp and hold eyelid tissue positioned between the opposing first tissue contact surface 306 and the second tissue contact surface 308. The device 300 can be used in combination with a grasping tool. The device 300 can also include a jaw actuation handle 320 and a jaw actuation lift 330.

[0079] Embodiments of the present invention provide a unique blepharoplasty system, including associated devices, kits, and methods for removing excess eyelid skin tissue and sealing incised skin. An exemplary device may include two curved serrated skin contacting jaws, one of which is fixed (e.g., upper member 302) and one of which is actuated between a closed position and an open position (e.g., lower member 304), wherein the open position allows eyelid skin tissue to protrude between the jaws and the closed position clamps the skin tissue, thereby restricting blood flow to the eyelid skin tissue. The actuation mechanism may include a lever or handle having pivotal rotation to adjust the linear position of the actuated jaw relative to the fixed jaw. For example, as Fig. 8A As shown, the jaw actuation handle 320 can pivot relative to the base 380 about the handle pivot 352. In some cases, the actuation jaws or handles can be coupled to a ratchet mechanism, thereby allowing the distance between the jaws to be locked in various distances between fully open (e.g., 8 mm) and fully closed (e.g., 0 mm). The ratchet mechanism may include a mechanism to release the coupling of the ratchet mechanism to allow the actuation jaws to be readjusted. In some embodiments, the device may include a cutting attachment or be configured to operate in association with a cutting attachment, and the cutting attachment may include an actuation mechanism to cut the clamped eyelid skin tissue.

[0080] In some embodiments, the blepharoplasty device may include silicone coated jaws (e.g., jaws 302, 304). The presence of silicone can be used to reduce the ability of the adhesive to adhere to the jaws of the device, thereby allowing the ability to seal the incision with the adhesive when the skin is clamped within the jaws.

[0081] Fig.9A and Fig. 9B Provided in an open position or configuration ( Fig.9A ) and in a closed position or configuration ( Fig. 9B ) is an additional view of the device 300 with the upper jaw and the lower jaw being further apart in an open position or configuration and the upper jaw and the lower jaw being closer together in a closed position or configuration. As shown here, the device 300 includes a handle pivot 352, a jaw actuation handle spring 354, and an actuation lift pivot 356. Thus, in contrast to devices that include a movable handle and a fixed handle that move in a linear motion, embodiments of the present invention include devices having a pivoting feature to provide a lever for actuating the adjustable jaws. Advantageously, the exemplary blepharoplasty system device uses pivoting rotation to establish linear adjustment between two surface contacting jaws. For example, as shown here, the handle 320 can be pressed in a downward pivoting direction as indicated by arrow A, resulting in upward movement of the handle extension 320A, which in turn causes linear upward movement of the lower jaw 304 relative to the upper jaw 302, as indicated by arrow B.

[0082] Fig. 10A Aspects of an embodiment of a blepharoplasty device 300 are shown, in accordance with an embodiment of the present invention. As shown therein, the blepharoplasty device 300 includes a handle mechanism 360 and a removable jaw mechanism 370. Fig. 10B Various aspects of a removable jaw mechanism 370 according to some embodiments are shown. The removable jaw mechanism 370 may include an actuating jaw guide locking column 372, a locking mechanism compression tab 374, and a locking (ratchet) mechanism 376. When locked, the locking (ratchet) mechanism 376 is operable to control the distance between the upper jaw member 302 and the lower jaw member 304. Embodiments of the present invention include devices with ratchet mechanisms to allow the actuating jaws to be locked at various distances and to allow the skin tissue object to be adjusted for removal. In some embodiments, the column 372 may constitute or be part of a support assembly 373 of the first jaw member 302. In some embodiments, the support assembly 373 includes a recessed portion 375, and the base 380 includes a tab 382. The recessed portion 375 and the tab 382 may provide a connection that can be releasably engaged between the first jaw member and the base. In some cases, the support assembly 373 may include a plurality of recessed portions, and the base 380 may include a plurality of tabs.

[0083] FIG. 11A to FIG. 11D Various aspects of a removable jaw mechanism 370 are shown according to some embodiments. Fig. 11B372 and the locking (ratchet) mechanism 376. For example, the teeth of the locking (ratchet) mechanism 376 may engage the teeth of the actuating jaw guide locking post 372 at engagement areas A and B. Fig. 11C As shown, the locking mechanism compression tabs 374 can be moved closer together toward each other (e.g., in the directions indicated by arrows C and D) to compress the locking (ratchet) mechanism 376 from each side, thereby disengaging the locking (ratchet) mechanism 376 from the actuating pawl guide locking column 372, as shown in FIG. Fig.11D Therefore, Fig.11A and Fig. 11B shows a configuration in which the locking mechanism is engaged, and Fig. 11C and Fig.11D The configuration in which the locking mechanism is released or disengaged is shown. When the locking mechanism is released or disengaged, the positioning of upper jaw member 302 relative to lower jaw member 304 can be adjusted or readjusted because the upper jaw member is in a fixed relationship relative to actuating jaw guide locking post 372.

[0084] Thus, embodiments of the present invention include devices having ratchet mechanisms that may include serrations, teeth, gears, etc. on each end of a post coupled to the actuating jaws of the device. An exemplary ratchet or locking mechanism 376 may include a series of cutouts or a spiral portion that provides flexure that allows the entire elongated body to compress, decoupling the ratchet from the actuating jaws, thereby allowing adjustment of the tissue desired to be removed.

[0085] FIG. 12A to FIG. 12D Various aspects of a removable jaw mechanism 370 are shown according to some embodiments. Fig. 12B 372 and the locking (ratchet) mechanism 376. For example, the teeth of the locking (ratchet) mechanism 376 may engage the teeth of the actuating jaw guide locking post 372 at engagement areas A and B. Fig. 12C As shown, the locking mechanism compression tabs 374 can be moved closer together toward each other (e.g., in the directions indicated by arrows C and D) to compress the locking (ratchet) mechanism 376 from each side, thereby disengaging the locking (ratchet) mechanism 376 from the actuating pawl guide locking column 372, as shown in FIG. Fig.12D Therefore, Fig. 12A and Fig. 12B shows a configuration in which the locking mechanism is engaged, and Fig. 12C and Fig.12D The configuration in which the locking mechanism is released or disengaged is shown. When the locking mechanism is released or disengaged, the positioning of upper jaw member 302 relative to lower jaw member 304 can be adjusted or readjusted because the upper jaw member is in a fixed relationship relative to actuating jaw guide locking post 372.

[0086] Thus, embodiments of the present invention provide a device having a ratchet mechanism that includes an elongated body 376 having teeth 376A, 376B on each end that couple with a post 372 of the device actuating jaw 304. The ratchet mechanism may have a series of cutouts or spiral portions that provide flexure that allows the entire elongated body to compress, thereby decoupling the ratchet from the actuating jaw. The ratchet mechanism may have a post 372 that extends perpendicular to the elongated body 376, thereby allowing manual decoupling of the ratchet mechanism from the actuating jaw and actuation from a closed position to an open position. Fig.12E Eyelid tissue T is shown disposed between the upper jaw 302 and the lower jaw 304 .

[0087] FIG. 13A to FIG. 13C Various aspects of an attachable cutting mechanism 400 according to an embodiment of the present invention are shown. The attachable cutting mechanism 400 may include an actuated cutting guide locking post 472, a locking mechanism compression tab 474, and a locking (ratchet) mechanism 476. When locked, the locking (ratchet) mechanism 476 is operable to control the distance between the upper cutting member 402 and the lower cutting member 404. According to some embodiments, the locking mechanism components of the attachable cutting mechanism 400 operate in a manner similar to the locking mechanism components of the removable jaw mechanism 370. FIG. 13A to FIG. 13C The attachable cutting mechanism 400 is shown in a closed or cutting position or configuration. Fig.13D Eyelid tissue T is shown disposed between upper cutting member 402 and lower cutting member 404. In some embodiments, a blepharoplasty device may include silicone-coated jaws (e.g., jaws 402, 404). The presence of silicone may be used to reduce the ability of the jaws to adhere to the skin, thereby allowing the ability to seal the incision with an adhesive when the skin is clamped within the jaws.

[0088] FIG. 14A to FIG. 14C Various aspects of an attachable cutting mechanism 400 according to an embodiment of the present invention are shown. The attachable cutting mechanism 400 may include an actuated cutting guide locking column 472, a locking mechanism compression tab 474, and a locking (ratchet) mechanism 476. When locked, the locking (ratchet) mechanism 476 is operable to control the distance between the upper cutting member 402 and the lower cutting member 404. The upper cutting member 402 includes a cutting blade recess 403, and the lower cutting member 404 includes a cutting blade 404, which is configured to engage the recess 403 to perform cutting of tissue when the tissue is disposed between them. In some cases, the recess is disposed on the lower member 404, and the blade is disposed on the upper member 402. According to some embodiments, the locking mechanism components of the attachable cutting mechanism 400 operate in a manner similar to the locking mechanism components of the removable jaw mechanism 370. FIG. 14A to FIG. 14C The attachable cutting mechanism 400 is shown in an open position or configuration. Fig.14D Eyelid tissue T is shown disposed between upper cutting member 402 and lower cutting member 404. Thus, such a cutting attachment 400 can be actuated in an upper and lower direction through skin tissue to remove a desired amount of skin tissue. According to some embodiments, FIG. 13A to FIG. 13C The use of the removable jaw mechanism 370 shown can be combined with FIG. 14A to FIG. 14C In some embodiments, the clamping force and the skin response under the saw teeth can be operated to retain the skin portion (desired to be removed) after the clamp is released (e.g., after Fig.12E The jaws 302, 304 are shown separated) and remain protruding. The cutting mechanism can then be attached to the handle mechanism and / or the base and surround the protruding tissue and actuate to remove it (e.g., as Fig.13D shown).

[0089] The blepharoplasty device embodiments disclosed herein can be provided in a variety of widths to allow for alternative solutions for varying patient anatomies. In some cases, the cutting mechanism can be preassembled within a device that clamps the skin (e.g., Figure 1A and Figure 1B as well as 6A to 6F In some cases, the cutting mechanism may be provided as a separate component from the device for clamping the skin (e.g., as shown in FIG. 14A to FIG. 14C shown).

[0090] In some cases, the cutting mechanism can be a sliding cutting mechanism that actuates in a medial-lateral direction perpendicular to the clamped tissue, e.g. 6A to 6F Thus, embodiments of the present invention include devices having a cutting mechanism that can cut skin sliding in a medial-lateral direction. In some cases, the cutting mechanism can be actuated in an up-down direction perpendicular to the surface of the skin tissue, e.g., FIG. 14A to FIG. 14C Thus, embodiments of the present invention include devices that can cut skin using a cutting mechanism that moves perpendicular to the clamped skin area.

[0091] Fig.15A and Fig. 15B One embodiment of a blepharoplasty device 1500 is shown that is configured to capture eyelid tissue to facilitate removal of tissue from a portion of the eyelid. Device 1500 is a tissue gripping device (e.g., a clamp) that includes a pair of elongated jaw members 1502, 1504 that are operably connected together so that they can be moved relative to each other in an open position ( Fig. 15B ) and closed position ( Fig.15A). Upper jaw member 1502 and lower jaw member 1504 may bend to follow the contour of the eyelid area to produce a desired incision shape. In some embodiments, the jaw members may have an upper and lower curve with a radius of 1 3 / 8 inches and an anterior and posterior curve with a radius of 1 5 / 8 inches to establish the contour. In some cases, the contour formed is established by imaging of the patient's anatomy.

[0092] In some embodiments, due to their relative positions relative to the head and foot, the upper jaw member will be considered an upper jaw member and the lower jaw member will be considered a lower jaw member. For simplicity, the terms "upper" and "lower" are used herein to refer to the upper member and the lower member, but it should be understood that "upper" and "lower" do not imply any positional relationship other than anatomical reference points of the body.

[0093] Upper jaw member 1502 has a first tissue contacting surface 1506, and lower jaw member 1504 has a second tissue contacting surface 1508. First tissue contacting surface 1506 and second tissue contacting surface 1508 generally face one another in an opposing manner such that when eyelid tissue is positioned between upper jaw member 1502 and lower jaw member 1504, first tissue contacting surface 1506 and second tissue contacting surface 1508 may move toward one another to capture and secure the eyelid tissue between first tissue contacting surface 1506 and second tissue contacting surface 1508. In some embodiments, first tissue contacting surface 1506 and second tissue contacting surface 1508 have respective serrated portions facing one another.

[0094] When upper jaw member 1502 and lower jaw member 1504 are in the open position ( Fig. 15B ), first tissue contact surface 1506 and second tissue contact surface 1508 are separated by a certain distance to form an opening or space large enough to receive eyelid tissue. When upper jaw member 1502 and lower jaw member 1504 are moved together to a closed position ( Fig.15A ), the distance between the first contact surface 1506 and the second contact surface 1508 is reduced to a smaller distance. Due to the smaller distance, the opening or space between the first tissue contact surface 1506 and the second tissue contact surface 1508 is small enough to capture and fix any eyelid tissue positioned between the first tissue contact surface 1506 and the second tissue contact surface 1508.

[0095] The first tissue contacting surface 1506 and the second tissue contacting surface 1508 are configured to clamp and hold eyelid tissue positioned between the opposing first tissue contacting surface 1506 and the second tissue contacting surface 1508. The device 1500 also includes a cutting member or cutting mechanism slide 1560. The cutting mechanism slide 1560 may include a cutting blade (not shown) or be coupled to a cutting blade, and the blade may be movable along and / or within a blade guide 1544. As shown here, the blade guide 1544 may be a curved slit, track, or edge along the upper jaw 1502. Advantageously, as further discussed herein, such a cutting mechanism may be actuated through skin tissue in a medial to lateral direction to remove a desired amount of skin tissue. In some embodiments, the lower jaw member 1504 may be referred to as an actuating jaw. As shown in FIG. Fig.15A and Fig. 15B As shown, the actuating jaw 1504 may include a tissue contact side 1505. In some cases, the tissue contact side 1505 may be referred to as an eyelid contact surface or an eyelid contact contoured surface. The device 1500 may also include an actuating jaw lever or lever mechanism 1520, and a locking mechanism 1530, such as a lever latch locking mechanism or a ratchet mechanism column. Embodiments of the present invention include devices with ratchet mechanisms to allow the actuating jaws to be locked at various distances and to allow adjustment of the skin tissue object for removal. In some cases, the locking mechanism may be attached to the actuating handle component of the device.

[0096] Thus, embodiments of the present invention provide unique blepharoplasty systems, including related devices, kits, and methods for removing eyelid skin tissue and sealing incised skin. An exemplary device may include two curved serrated skin contacting jaws, one of which is fixed (e.g., upper member 1502) and one of which is actuated (e.g., lower member 1504), whereby the configuration of the device may be in a closed position (e.g., Fig.15A ) and the open position (e.g. Fig. 15B ), wherein the open position allows eyelid skin tissue to protrude between the jaws, and the closed position clamps the skin tissue, thereby restricting blood flow to the eyelid skin tissue. The actuation mechanism may include a lever 1520 having a pivot 1522, whereby actuation of the actuation jaw lever 1520 about the pivot 1522 enables adjustment of the linear position of the actuation jaw 1504 relative to the fixed jaw 1502 (e.g., between Fig. 15B The open configuration shown is similar to Fig.15A Between the closed configurations shown, in the open configuration, the lever 1520 is in an upward position, and in the closed configuration, the lever is in a downward position).

[0097] In some cases, the fixed jaw 1502 (or a component in fixed relation to the fixed jaw) can be releasably coupled to the ratchet mechanism 1530, thereby allowing the distance between the jaws 1502, 1504 to be locked in various distances between fully open (e.g., 8 mm) and fully closed (e.g., 0 mm). The ratchet mechanism 1530 may include a mechanism to release the coupling of the ratchet mechanism to allow readjustment of the operating jaw 1504. As further discussed elsewhere herein, in some embodiments, the device may include a cutting attachment or be configured to operate in association with a cutting attachment, and the cutting attachment may include an actuation mechanism to cut the clamped eyelid skin tissue.

[0098] In some embodiments, the blepharoplasty device may include silicone coated jaws (e.g., jaws 1502, 1504). The presence of silicone can be used to reduce the ability of the adhesive to adhere to the jaws of the device, thereby allowing the ability to seal the incision with the adhesive when the skin is clamped within the jaws.

[0099] Fig.16A and Fig. 16B Provided in an open position or configuration ( Fig. 16B ) and in a closed position or configuration ( Fig.16A ) with the upper jaw 1502 and the lower jaw 1504 further apart in an open position or configuration and the upper jaw 1502 and the lower jaw 1504 closer together in a closed position or configuration. Alternating between the open configuration and the closed configuration can involve linear movement of the lower (e.g., actuating) jaw 1504 relative to the upper (e.g., fixed) jaw 1502, as indicated by arrow A. The first contact surface 1506 and the second contact surface 1508 can have serrated edges. Thus, embodiments of the present invention include devices having jaws with serrations to allow the clamped skin to be squeezed onto itself, thereby forming a desired location for cutting. The serrations can be interlocking, thereby allowing the skin tissue to be deformed to such an extent that the desired amount of skin for removal remains protruding and the skin remains squeezed after the clamp is released.

[0100] Fig.17A and Fig. 17B Provided in a closed position or configuration ( Fig.17A ) and in the open position or configuration ( Fig. 17B ) with the upper and lower jaws closer together in a closed position or configuration and the upper and lower jaws further apart in an open position or configuration. The device 1500 can include an actuating jaw lever 1520 and a locking mechanism 1530 such as a lever latch locking mechanism or a ratchet mechanism post. Pivot 1522 enables the actuating jaw lever 1520 to pivot relative to a base 1580 of the device 1500.

[0101] Fig.18A and Fig.18B Additional views of the device 1500 are provided in a closed position or configuration, wherein the upper jaw and the lower jaw are closer together or in contact with each other. The device 1500 may include an actuating jaw lever 1520 having a locking mechanism 1530, such as a lever latch locking mechanism or a ratchet mechanism post. The device 1500 may also include a latch mechanism 1540 having a latch mechanism engagement member 1541. Fig.18A As shown, the latch mechanism engagement member 1541 can engage the locking mechanism 1530 such that the latch mechanism 1540 and the locking mechanism 1530 are in a locked configuration relative to each other.

[0102] like Fig.18B As shown, the latch mechanism engagement member 1541 can be disengaged from the locking mechanism 1530 so that the latch mechanism 1540 and the locking mechanism 1530 are not in a locked configuration relative to each other. This can be achieved by moving the latch mechanism in a latch release motion or distal direction (as shown by arrow A), which can thereby operate to compress the latch spring 1550 (e.g., compressing the spring 1550 between the base 1580 and the latch mechanism 1540). Fig. 18C A cross-sectional view of the device 1500 in an open configuration is provided. As shown, here, the actuation jaw lever 1520 is pivotable relative to the handle 1580 via an actuation jaw lever pivot 1522 .

[0103] Fig.19A and Fig.19B Provided in a closed position or configuration ( Fig.19A ) and in the open configuration ( Fig.18B ), in a closed position or configuration, the upper jaw 1902 and the lower jaw 1904 are closer together or in contact with each other, and in an open configuration, the upper jaw 1902 and the lower jaw 1904 are further apart from each other. The device 1900 may include an actuating jaw lever 1920 having a locking mechanism 1930, such as a lever latch locking mechanism or a ratchet mechanism post. The device 1500 may also include a latch mechanism 1540 having a latch mechanism engagement member 1541. The latch mechanism engagement member 1941 may engage the locking mechanism 1930 so that the latch mechanism 1940 and the locking mechanism 1930 are in a locked configuration relative to each other. The latch mechanism engagement member 1541 may be disengaged from the locking mechanism 1530 so that the latch mechanism 1540 and the locking mechanism 1530 are not in a locked configuration relative to each other. This may be achieved by moving the latch mechanism in a latch release motion or distal direction, as indicated by arrow A. When the actuating jaw lever 1920 and the handle 1980 are forced or squeezed together, as Fig.19AAs shown, the lever spring 1950 is compressed. When the actuating jaw lever 1920 and the handle 1980 are allowed to move away from each other, as shown in FIG. Fig.19B As shown, lever spring 1950 is not compressed. In some embodiments, lever spring 1950 can be referred to as a lever actuated torsion spring. In some embodiments, the lever actuated torsion spring is configured to bias the second jaw member away from the first jaw member. In some embodiments, the biasing force of lever spring 1950 can operate to move actuating jaw lever 1920 away from handle 1980, such as moving around actuating jaw lever pivot 1922.

[0104] FIG. 20A to FIG. 20C Various illustrations of a blepharoplasty device 2000 according to an embodiment of the present invention are provided. As shown here, the device 2000 can include a cutting mechanism 2140 having a cutting member or blade 2142. The cutting member 2142 can have one or more cutting edges 2143. The cutting mechanism 2140 can be a sliding cutting mechanism and can slide from one side of the device to the opposite side of the device, or vice versa, such as in the direction indicated by arrow A. As shown here, the blade 2142 can slide along or within a blade guide 2144 of the upper jaw 2102.

[0105] FIG. 21A to FIG. 21C Various illustrations of a blepharoplasty device 2100 according to an embodiment of the present invention are provided. As shown therein, the device 2000 may include a cutting mechanism 2240. The cutting mechanism 2240 may be a sliding cutting mechanism and may slide from one side of the device to the opposite side of the device and vice versa, for example in the direction indicated by arrow A.

[0106] Fig.22A and Fig. 22B Shown in an open position or configuration ( Fig.22A ) and in a closed position or configuration ( Fig. 22B ) in various aspects of a grasping tool or forceps 2200. The grasping tool 2200 may include skin contact serrations 2210. The grasping tool may be used (e.g., by a surgeon or operator) to position patient tissue relative to a blepharoplasty device. For example, when the blepharoplasty device is in an open position, a portion of patient tissue may be positioned between its upper jaw and lower jaw. The grasping tool 2200 may be used to facilitate movement of tissue into the space between the upper jaw and the lower jaw. For example, the grasping tool 2200 may clamp the patient's upper eyelid tissue and pull it away from the patient and into the space between the upper jaw and the lower jaw. As shown here, the grasping tool or forceps 2200 provides a curved grasping surface 2230.

[0107] FIG. 22C to FIG. 22EVarious aspects of a gripping tool or forceps 2200A in an open position or configuration are shown. The gripping tool 2200A may include a microneedle 2210A at one or both distal ends 2205A thereof. In use, the microneedle may be operable to sensitize the tissue to a local anesthetic and / or manipulate the tissue. The gripping tool may be used to position patient tissue relative to a blepharoplasty device (e.g., by a surgeon or operator). For example, when the blepharoplasty device is in an open position, a portion of the patient's tissue may be positioned between its upper jaw and lower jaw. The gripping tool 2200A may be used to facilitate movement of tissue into the space between the upper jaw and the lower jaw. For example, the gripping tool 2200A may clamp the patient's upper eyelid tissue and pull it away from the patient and into the space between the upper jaw and the lower jaw. As shown here, the gripping tool or forceps 2200A provides a curved gripping surface 2230.

[0108] Embodiments of the present invention may include a kit with a skin grasping tool (e.g., tweezers 2200 or 2200A), a local anesthetic, an incision adhesive, a marker pen, and an iodine swab. A grasping tool (e.g., tweezers 2200 or 2200A) may have an elongated body divided into two serrated tissue contact surfaces at a distal end. The contact surface may be curved fairly with the anterior-posterior curve of the eyelid skin tissue. The distal end contact surface may be adjusted between two distances of an open position (e.g., 8mm) and a closed position (e.g., 0mm). In some embodiments, the distance between the surfaces can be adjusted manually by compression. The serrations on the contact surface may provide a shear force between the eyelid skin tissue and the grasping tool, thereby allowing the skin tissue to be positioned by the jaws of the device component. The elongated body may include a portion with a reduced width to be assembled through the open jaws of the device component. In operation, a skin grasping tool (e.g., tweezers 2200 or 2200A) may be assembled through the device from a forward direction, and unfolded and compressed to grab or grasp and pull the tissue through.

[0109] Fig.23A and Fig. 23B Aspects of a blepharoplasty procedure are illustrated, showing the configuration of the eyelid tissue T after release of the clamp or device.

[0110] An exemplary treatment process may include marking the area of ​​eyelid tissue desired to be removed with a marking pen and providing a local anesthetic to temporarily anesthetize the surgical area. After the surgical area is fully anesthetized, the surgical site can be disinfected with an iodine swab. A grasping tool can enter through the open jaws of the device, compress into a closed position, and grab or grasp the marked eyelid skin tissue area, and then pull the tissue through the open jaws of the device. The device can then be completely closed, thereby clamping the tissue and cutting off blood flow. The eyelid skin tissue can then be removed using a cutting mechanism. After removing the tissue, an incision adhesive can be applied to the incision to seal the incision and allow it to heal.

[0111] Any of the blepharoplasty systems, devices, kits, or methods disclosed herein can be used for any cosmetic skin removal (e.g., eyebrows, cheeks, underarms, neck, etc.). In some embodiments, one or more components of the blepharoplasty device can be made of medical grade plastic. In some embodiments, one or more components of the blepharoplasty device (e.g., the cutting blade component) can be made of stainless steel or plastic. In some cases, the grasping tool or forceps can be made of stainless steel or plastic.

[0112] In some embodiments, the width of the clamped skin has a value in the range of about 35 mm to about 45 mm. In some cases, the distance between the jaws has a value in the range of about 0 mm to about 10 mm.

[0113] Advantageously, any of the blepharoplasty systems, devices, kits, or methods disclosed herein can be used in an office setting, thus avoiding the expense and inconvenience of a hospital or surgical center. The local anesthetic can be temporary and targeted to the surgical area, thus avoiding general anesthesia. In some embodiments, the surgery takes about 10 minutes to complete after the local anesthetic. The adjustability of the device can allow for adjustment of the amount of eyelid tissue to be removed, thereby reducing asymmetric complications. The embodiments disclosed herein can also eliminate the need for sutures and can reduce bruising, bleeding, and postoperative recovery.

[0114] While the foregoing description contains significant details relating to certain preferred embodiments, this should not be construed as limiting the scope of the invention but rather as providing an illustration of the preferred embodiments.

[0115] Embodiments of the invention include kits having a blepharoplasty system as disclosed herein. In some embodiments, the kit includes one or more blepharoplasty system components, and instructions for using the device, for example, according to any of the methods disclosed herein.

[0116] All features of the described systems and devices apply mutatis mutandis to the described methods and vice versa.

[0117] Each reference provided herein is incorporated by reference in its entirety to the same extent as if each reference was individually incorporated by reference. Relatedly, all publications, patents, patent applications, journal articles, books, technical references, etc. mentioned in this specification are incorporated by reference herein to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference, etc. was specifically and individually indicated to be incorporated by reference.

[0118] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be appreciated by those skilled in the art that certain changes, modifications, alternative constructions and / or equivalents may be practiced or employed as desired and within the scope of the appended claims.

Claims

1. A device for removing excess skin and forming wound closure, the device comprising: Pedestal; a lever mechanism, the lever mechanism being coupled to the base; Locking mechanism; an elongated, curved first jaw member in fixed relation to the base and having a lower tissue contacting surface; an elongated, curved second jaw member in movable relation to the base and having an upper tissue contacting surface, the upper tissue contacting surface of the second jaw member facing the lower tissue contacting surface of the first jaw member; and wherein pivotal actuation of the lever mechanism causes movement of the second jaw member relative to the first jaw member, and Wherein the locking mechanism is configured to maintain the first jaw member and the second jaw member in a fixed relationship relative to each other.

2. The device of claim 1, wherein the lower tissue contacting surface is serrated, and wherein the upper tissue contacting surface is serrated.

3. The device of claim 1, wherein the lever mechanism is coupled to the base via a lever pivot.

4. The device of claim 1, wherein pivotal actuation of the lever mechanism causes linear movement of the second jaw member relative to the first jaw member.

5. The device of claim 1, wherein the locking mechanism is releasably engaged with the second jaw member. The device of claim 1 , wherein the locking mechanism is coupled to the base via a locking pivot.

7. The device of claim 1, further comprising a latch mechanism, wherein the locking mechanism is releasably engaged with the latch mechanism.

8. The device of claim 7, wherein the locking mechanism releasably engages the latching mechanism at a location within the base.

9. The device of claim 7, wherein the latch mechanism is coupled to the second jaw member.

10. The device of claim 7, further comprising a latch spring compressible between the latch mechanism and the base.

11. The device of claim 10, wherein the latch spring biases engagement of the latch mechanism against the locking mechanism.

12. The device of claim 1, wherein the locking mechanism is coupled to the lever mechanism.

13. The device of claim 1 further comprising a pawl in fixed relation to the second jaw member, wherein the locking mechanism comprises an engagement tooth configured to releasably engage the pawl.

14. The device of claim 13, further comprising a locking spring configured to bias the engagement tooth of the locking mechanism against the pawl.

15. The device of claim 1, wherein at least one of the first jaw member or the second jaw member has a silicone coating.

16. The device of claim 1, further comprising an actuating jaw spring configured to bias the second jaw member away from the first jaw member.

17. The device of claim 1, further comprising a lever-actuated torsion spring configured to bias the second jaw member away from the first jaw member.

18. The device of claim 1, wherein at least one of the first jaw member or the second jaw member comprises a tissue contacting side having a contoured surface having a shape customized to the anatomy of the patient based on an imaging scan of the patient.

19. A redundant skin removal and wound closure device, the device comprising: Pedestal; a lever mechanism coupled to the base via a lever pivot; Locking mechanism; an elongated curved first jaw member in fixed relation to the base and having a lower serrated tissue contacting surface; an elongated, curved second jaw member in pivotal relationship with the lever and having an upper serrated tissue contacting surface facing the lower serrated tissue contacting surface of the first jaw member; wherein the locking mechanism is releasably engageable with a support assembly of the first jaw member, and Wherein pivotal actuation of the lever mechanism causes linear movement of the second jaw member relative to the first jaw member.

20. The device of claim 19, wherein the locking mechanism comprises first and second sets of engaging teeth that releasably engage the support assembly of the first jaw member.

21. The device of claim 19, wherein the locking mechanism comprises a threaded portion capable of compressing the locking mechanism.

22. The device of claim 19, further comprising a jaw actuation handle spring coupled to the base and the lever mechanism.

23. The device of claim 19, wherein the support assembly of the first jaw member is releasably engaged with the base.

24. The device of claim 19, wherein the locking mechanism comprises one or more locking mechanism compression tabs.

25. A method of performing an excess skin removal and wound closure procedure, the method comprising: grasping the patient's tissue with grasping tools; positioning the tissue between an upper jaw mechanism and a lower jaw mechanism of an excess skin removal and wound closure device; pivoting a lever of the excess skin removal and wound closure device relative to a base of the excess skin removal and wound closure device to cause advancement of the lower jaw mechanism toward the upper jaw mechanism to clamp the tissue therebetween; forming an incision in the tissue; as well as A portion of the tissue is removed from the patient.

26. The method of claim 25, wherein pivoting the lever of the excess skin removal and wound closure device relative to the base of the excess skin removal and wound closure device causes linear advancement of the lower jaw mechanism toward the upper jaw mechanism.

27. The method of claim 25, further comprising applying an adhesive to the cutout.

28. The method of claim 25, further comprising inserting the grasping tool between the upper jaw mechanism and the lower jaw mechanism of the excess skin removal and wound closure device before grasping the tissue with the grasping tool.

29. The method of claim 25, wherein the positioning step comprises removing the grasping tool from between the upper jaw mechanism and the lower jaw mechanism of the excess skin removal and wound closure device.

30. The method of claim 25, wherein the lever pivots relative to a support assembly of the upper jaw mechanism when the lever pivots relative to the base.

31. The method of claim 25, wherein the lever slides relative to a support assembly of the upper jaw mechanism as the lever pivots relative to the base.

32. The method of claim 25, further comprising locking the lower jaw mechanism in place relative to the upper jaw mechanism prior to forming the incision.

33. The method of claim 32, wherein the locking step comprises pivoting a locking mechanism of the excess skin removal and wound closure device.

34. The method of claim 32, wherein the locking step comprises compressing a locking mechanism of the excess skin removal and wound closure device.

35. The method of claim 25, wherein the grasping tool comprises a distal end having a microneedle.

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