Automated skin closure system

Abstract

The present invention relates to a surgical system comprising a device for deploying bioabsorbable fasteners into tissue to secure portions of tissue around an incision or wound on the skin of a patient to effectively close the incision or wound.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Application No. 63 / 603,769, filed November 29, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to medical devices, and more specifically to a surgical system including means for applying bioabsorbable fasteners into tissue to secure tissue portions surrounding an incision or wound on a patient's skin, thereby effectively closing the incision or wound. Background Technology

[0004] When sutures are manually applied to close incisions or wounds in tissue, the sutures pass through the tissue and are knotted to hold the edges of the wound or incision together to promote healing. With the development of synthetic absorbable materials, the use of bioabsorbable suture materials has become common. These bioabsorbable suture materials are inserted below the skin surface and are reabsorbed by the body once healing is complete. Several different techniques exist for engaging the tough dermis and achieving a secure closure, involving the needle path, where to knot, etc. The dermis, typically less than two (2) millimeters thick, is the toughest of the three layers that make up human skin tissue. Surgeons “feel” the resistance of the needle as it penetrates the dense dermis and skillfully guide the needle in and out to a depth and a sufficient “engagement” to be appropriate for the tissue and the stress the wound may experience during healing.

[0005] While manual suturing remains a common method for closing incisions and wounds, this procedure can be time-consuming, requires a certain level of skill, and carries the risk of needle accidents (e.g., accidental pricks). Therefore, many practitioners now use surgical staplers to deliver staples into the tissue to keep incisions closed for healing. These surgical staplers deliver metal staples with sharp tips that allow them to pierce tissue. When deployed, the stapler device bends the metal staple into a closed shape to hold the tissue edges together. One disadvantage of metal staples is that a portion of the staple must remain exposed above the skin surface to allow medical professionals to remove it once biological healing is complete. The exposed portion is unsightly, and the puncture site where the staple entered the skin poses a risk of infection. Furthermore, these delayed-healing percutaneous points can become covered with scar tissue, often resulting in a "railroad track" appearance with pairs of small dots on either side of the linear incision line representing the points where the staple pierced the skin.

[0006] To address the drawbacks of metal sutures, several inventors have proposed fasteners made of bioabsorbable materials that can be placed beneath the skin surface. One such device is described in U.S. Patent No. 8,506,591 to Danielson et al. (“Danielson”), entitled “Tissue Fasteners and Related Insertion Devices, Mechanisms, and Methods.” Danielson’s device requires two operators: one person uses tissue forceps to evert the two sides of the incision with both hands, while the second person operates the suture device. More recently, U.S. Patent No. 11,826,049 to Rogers et al. (“Rogers”), entitled “Devices for Deploying Tissue Fasteners,” describes devices that can be operated by a single user, incorporating functionality to perform certain tasks typically done by a second operator.

[0007] All existing methods and devices for closing incisions require surgically trained operators with significant skills, training, and experience. However, skin closure is often the last task in a lengthy surgical procedure, and one or more specialists performing the procedure may become fatigued or have other cases to attend to. Leaving skin closure to less skilled personnel carries the risk of complications, surgical site infections, or unsightly scarring. Regardless of who performs the skin closure, it can be tedious and time-consuming. Summary of the Invention

[0008] This invention improves upon and expands upon the functionality of the device described by Danielson and Rogers. In particular, it addresses the limitations of current methods and devices by providing an automated skin closure system configured to operate with minimal intervention from a skilled operator and without the need for a surgeon. This system enables rapid deployment of bioabsorbable fasteners to achieve a secure skin closure for wounds or incisions without complications and with minimal scarring. This invention enables automated skin closure for a wide range of surgical procedures.

[0009] Closing wounds or surgical incisions in a manner that avoids complications and minimizes scarring presents several requirements. The present invention achieves the desired results by implementing some or all of the eight (8) inventive elements described herein.

[0010] 1. First, the system utilizes a bioabsorbable fastener comprising two legs and configured to penetrate opposite sides of an incision or wound. As will be described in more detail herein, the system is configured to deploy a bioabsorbable fastener of the type illustrated and described by Danielson. However, it should be noted that other embodiments of bioabsorbable fasteners are contemplated for use with and deployment by the disclosed system. To meet the requirements of the invention, a given bioabsorbable fastener has two legs configured to penetrate tissue, but also configured to prevent reverse movement or removal. This anti-reverse capability includes, but is not limited to: barbs oriented to prevent backward movement; folds that form a larger profile after penetration to prevent return via the same path; or legs that lock together after penetrating opposite sides of the incision or wound, respectively. Conventional suture staples do not meet these requirements because they retain tissue by maintaining a closed "horseshoe" shape and require high bending strength. The key difference of the bioabsorbable fastener of the present invention is that it is designed to be flexible and to hold the opposite sides of a wound or incision together by the tensile strength of the connecting element between the two legs.

[0011] The bioabsorbable fastener is delivered by a fastener delivery mechanism that contains multiple fasteners within a cartridge. The fasteners are delivered one by one by mechanical elements, including a plunger needle assembly and an insertion device that travels in a guide rail and passes through the distal end of the fastener delivery mechanism.

[0012] 2. According to the invention, tissue at opposite sides of the incision is positioned adjacent to the exit portion of the fastener delivery mechanism, such that the point at which each fastener leg enters the tissue as the bioabsorbable fastener passes through the exit is retracted from the incision edge. The term "retracted" derives from a manual procedure known as retracted subcutaneous suture technique, an interrupted vertical suturing technique first published by Jonathan Kantor in 2010 (J. American Academy Dermatology, February 2010, pp. 352-353, "Letter to the Editor," Jonathan Kantor). Wang et al. (J Am Acad Dermatol, April 2015, 72(4), 674-680, “Setback versus buried vertical mattress suturing: Results of a randomized blinded trial”, Wang AS, Kleinerman, R, Armstrong, AW, Fitzmaurice, S, Pascucci A, Awasthi S, Ratnarathorn M, Sivamani R, King TH, Eisen DB) demonstrated that the setback technique provides superior wound eversion, better cosmetic results, and reduces suture delamination compared to conventional suturing techniques. This invention improves the setback technique by controlling the setback distance according to the geometry of the fasteners. Controlling the setback distance achieves uniform eversion of the relative edges and disperses forces that could cause the incision to break. The degree of "extension" refers to the arching of the tissue edges, which helps to keep the edges in close contact even when the tissue is in motion or subjected to traction forces.

[0013] 3. This system enables tissue positioning relative to the outer surface of the skin, ensuring that the path of the fastener leg is at a controlled distance from the outer surface or epidermis. The epidermis is the thinnest of the three layers of human skin, typically less than 1 mm. The dermis lies directly beneath the epidermis. The dermis is the strongest tissue and varies in thickness between 1 and 4 mm. The subcutaneous layer is the innermost layer of skin and consists of a network of fat and collagen cells, lacking the strength to keep an incision closed. In one embodiment, the fastener path is controlled at a specified distance from the outer surface of the skin, ensuring reliable positioning of the fastener within the dermis regardless of the total thickness of the skin tissue and its layers. We have determined that when the tissue is in the position where the fastener is inserted, the distance "D" between the outermost surface of the fastener leg and the outer surface of the skin should not exceed 0.27 mm and should typically be 0.17 mm.

[0014] 4. In one embodiment of the invention, particular consideration is given to maintaining a critical distance between the outer surface of the skin and the fastener during fastener insertion. This means that the front surface of the foot (where it contacts the outer surface of the skin) must not exhibit any significant degree of flexure, compression, or movement as the fastener penetrates the tissue. In one embodiment, the foot is part of a tissue retainer that is moved to the appropriate position by a mechanism to position the tissue for fastener insertion. We have determined that this mechanism must have sufficient stiffness to prevent backward movement. "Stiffness" as used herein refers to the force gradient, which is the derivative of force with respect to distance, i.e., df / dx. We have determined that the stiffness of the mechanism, measured by applying a force (df) at the front surface of the tissue retainer / foot (where it contacts the outer surface of the skin) and measuring the movement (dx), must exceed 20 lbf / mm when the foot is in the appropriate position to release the fastener. The invention achieves the required mechanical stiffness by actuating the tissue retainer / foot against a "stop" that prevents further movement once the tissue retainer / foot reaches the desired position. In one embodiment, the force applied by the tissue retainer / leg against the "stop" is between 8 and 15 lbf. In an alternative embodiment, the force applied by the tissue retainer to the "stop" is sustained for a short period after contact with the "stop" (i.e., so-called "overdrive") to compress one or more actuating elements a predetermined distance to ensure that the mechanism prevents the tissue retainer / leg from moving backward.

[0015] 5. To simultaneously engage the thin dermal layers on both sides of the incision, it is important that the fastener maintains the same spacing between itself and the tissue on both sides. Even minor differences in size, flexibility, or friction between the left and right components of the device can result in differences in the force required to press the tissue into place. If the difference is large enough, the fastener may not engage the dermis on one side, thus risking incision rupture. One embodiment of the invention provides a method to reduce or completely offset this risk by providing a centering mechanism that balances these forces and ensures equal spacing between the fastener and the prongs on each side of the incision. This is accomplished by rotatably attaching the proximal end of the fastener delivery mechanism and allowing its distal end to make a small amount of lateral movement in response to the forces applied by the tissue and tissue retainers. As an example, consider a tissue retainer on one side of the device applying twice the force compared to the other side. When the stronger tissue retainer contacts the fastener delivery mechanism, the fastener delivery mechanism moves, thus reducing the force; movement away from one side necessarily moves towards the other side, increasing the effective force acting on that other side. Therefore, any initial imbalance in the forces applied from one side relative to the other will be offset by the movement of the delivery mechanism until these forces reach equilibrium. In this way, the tracks of the fastener delivery mechanism and the guide insertion device are positioned centrally between the tissue retainer / leg.

[0016] 6. An insertion device carrying a bioresorbable fastener moves in a guide rail that allows the fastener to pass through an "exit" at the distal end of the fastener delivery mechanism. For free movement, a clearance, typically + / - 0.1 mm, must exist between the stationary and moving parts. To ensure this clearance exists in each device, tolerances for part dimensions, typically + / - 0.06 mm for injection molding, must also be considered. Unfortunately, the sum of these tolerances can exceed the allowable range of positions the fastener must hit. In one embodiment of the invention, the uncertainty of the fastener path is reduced by actively changing the size of the exit. During the initial movement of the insertion device, the exit is opened by approximately 0.2 mm to provide a degree of freedom of movement. The exit is then closed to interfere with the fastener for precise guidance as it passes through the exit and enters the tissue. Once the fastener is released into the tissue, the exit reopens to allow the mechanism to move freely back to its initial position.

[0017] 7. When a surgeon inserts a needle with standard suture material, the surgeon adjusts the applied force as needed to pierce the tissue. If the tissue is elastic, the needle is pushed in to the depth required to penetrate the dermis. The surgeon may not even know how many adjustments have been made from one patient to the next and from one body part to another. To automate skin closure, the present invention must adjust the force and / or insertion depth of the fastener in response to differences in tissue properties. In one embodiment, an electrically driven source or other power source with sensors providing feedback on position and force is configured to move the tissue retainer and the insertion device. We have measured the force versus distance curve of the insertion needle and compared it with similar measurements using barbed fasteners. The data for barbed fasteners have unique profile characteristics that can be analyzed in real time and used to immediately stop further insertion when the barbs of the fastener are fully engaged.

[0018] 8. In one embodiment of the invention, the suture insertion device is a replaceable component of an automated system, which further includes one or more grippers, a software-controlled vision system powered by artificial intelligence, and a programmable controller operatively coupled to the one or more grippers, the vision system, and the suture insertion device. As described in more detail herein, the controller is configured to perform electromechanical control on one or more grippers and one or more components of the suture insertion device in response to input received via one or more sensors, including input from the vision system, to provide autonomous or semi-autonomous delivery of bioresorbable fasteners, thereby securing opposite sides of an incision to effectively close the incision and promote healing.

[0019] As previously described, the inventive elements of the suture insertion device enable accurate and reliable placement of the fastener while requiring only simple tissue positioning. Specifically, this positioning is preferably accomplished by three (3) independent grippers, one located at the apex of the incision in front of the suture insertion device, and two grippers located rearward. The system is positioned above the patient, allowing the camera field of view and mechanical elements to identify and reach one or more incisions to be closed. For each incision, the forward gripper lifts the tissue at the apex, while the other two grippers lift and open the two edges of the incision behind the suture insertion device. As the grippers lift and open the incision, the "introducer" feature at the distal end of the fastener delivery mechanism lowers to a predetermined depth and moves to the apex. A motor controls the movement of the tissue retainer to partially engage the tissue. If the vision system confirms correct positioning, the tissue retainer is driven to its final position, and the motor driving the insertion device uses feedback-controlled depth to release the bioabsorbable fastener. Then, the insertion motor reverses to retract the needle tip for protection, the motor controlling the tissue retainer reverses and releases the tissue, and finally all actuators return to their original positions. If another fastener is to be applied, the guide suture insertion device is moved longitudinally along the incision away from the apex by a preset distance of 7 to 10 mm and re-engages the tissue with the tissue retainer. As the tissue retainer secures the tissue, all three grippers move to a distance corresponding to the distance the suture insertion device has moved and re-engage the tissue edges. These steps are repeated until the incision is closed. As the additional fastener is inserted, the rear gripper reaches the end of the incision and is guided by the controller to disengage and move away. When the incision is completely closed, the entire device is lifted and removed from the sterile area.

[0020] In one aspect, the present invention relates to an automated system for closing one or more incisions or wounds in a patient. The system includes a movable platform and a suture insertion device releasably coupled to a portion of the movable platform. The suture insertion device is configured to deploy a bioabsorbable fastener to close the incision or wound in the patient's tissue. The suture insertion device may typically be a disposable device. Accordingly, the movable platform is configured to receive and releasably hold interchangeable suture insertion devices.

[0021] The suture insertion device includes a body comprising a pair of tissue retainers positioned adjacent to a distal end of the body and operatively coupled to a first and second actuator associated with a movable platform. Each of the first and second actuators is configured to move a corresponding tissue retainer to effectively clamp and fold an edge of an incision or wound, thereby preparing for fastener release. The suture insertion device further includes a fastener delivery mechanism operatively coupled to the insertion actuator associated with the movable platform and configured to release one or more of a plurality of bioresorbable fasteners. The fastener delivery mechanism includes an insertion device comprising one or more insertion needles guided within a track and configured to move in response to movement of the insertion actuator, such that the one or more insertion needles releasably engage and release each of the plurality of fasteners in a sequential manner in response to repetitive movement of the insertion actuator. The fastener delivery mechanism also includes an inlet located at and extending distally from the fastener delivery mechanism. The inlet is configured to directly contact the opposing edges of the wound or incision and has an opening through which the fastener exits the distal end of the inlet during delivery. The fastener delivery mechanism further includes a pair of stop surfaces configured to directly contact a corresponding tissue retainer of a pair of tissue retainers, thereby positioning the outer skin surface of each edge of the incision or wound at the location of the opening relative to the distal end of the inlet.

[0022] The system further includes a controller operatively coupled to the movable platform and the suture insertion device. The controller includes a hardware processor coupled to a non-transitory computer-readable storage device containing instructions that the processor can execute to enable the controller to perform electromechanical control over: 1) movement of the platform, thereby causing a corresponding movement of the suture insertion device relative to the incision or wound; 2) actuation of a first actuator and a second actuator, thereby causing movement of a pair of tissue retainers; and 3) actuation of the insertion actuator, thereby causing one or more of a plurality of fasteners to be released via a fastener delivery mechanism.

[0023] In some embodiments, the controller is programmed to coordinate the movement of a pair of tissue retainers until each tissue retainer contacts its respective stop surface with substantially the same predetermined force. The controller may be further programmed to sequentially actuate an insertion actuator, thereby actuating a fastener delivery mechanism to deliver one of a plurality of fasteners to the distal end of the inlet at a controlled distance from the opening, and subsequently return the first and second actuators, as well as the insertion actuator, to their initial positions to prepare for the release of additional fasteners.

[0024] The controlled distance of movement of the fastener delivery mechanism relative to the distal end of the inlet can be determined by real-time analysis of the force applied by the insertion actuator.

[0025] In some embodiments, the predetermined force of each tissue retainer contacting the corresponding stop surface is between about 8 lbf and about 15 lbf. In some embodiments, the predetermined force of each tissue retainer contacting the corresponding stop surface provides resistance greater than about 20 lbf / mm to prevent reverse movement of each tissue retainer.

[0026] In some embodiments, the track for guiding the insertion device has a movable relationship with a pair of tissue retainers. For example, the pair of tissue retainers may be configured to allow the track to move in response to a force applied to the inserter, such that the track is substantially centered between the pair of tissue retainers.

[0027] In some embodiments, the opening in the introducer for the passage of a bioabsorbable fastener is configured to adjust its size during and after fastener placement. For example, the opening may be configured to change from a first size when the fastener moves within the opening during placement to a different second size after the fastener has been placed, in which the sides of the opening directly contact the fastener, and in which the opening is larger than the first size.

[0028] In some embodiments, the system may further include one or more tissue grippers operatively coupled to a movable platform and configured to engage patient tissue and lift the edges of an incision or wound to temporarily position each edge on opposite sides of the suture insertion device's inserter and adjacent to a corresponding tissue retainer on said given side of the inserter. A controller may be operatively coupled to the one or more tissue grippers and configured to perform electromechanical control on the one or more tissue grippers. For example, the controller may be configured to control the opening and closing of the grippers of each respective tissue gripper and the movement of the one or more tissue grippers.

[0029] In some embodiments, the system includes three tissue grippers. For example, a first tissue gripper is configured to clamp tissue at the apex of the distal end of the incision or wound, and a second and third tissue gripper are configured to clamp corresponding opposing edges of the incision or wound closer to the proximal end.

[0030] In some embodiments, the system includes a camera positioned to capture one or more images of the surgical field of view, including capturing one or more images of tissue around the incision or wound, one or more tissue grippers, the edges of the incision or wound, and the inserter of the suture insertion device.

[0031] The controller is operatively coupled to a camera and configured to receive image data from the camera, and based on analysis of the image data, the controller is configured to perform electromechanical control on at least one of the following: 1) movement of one or more tissue grippers; 2) control of the opening and closing of the grippers of a given tissue gripper; 3) movement of a platform, thereby causing a corresponding movement of a suture insertion device relative to an incision or wound; 4) actuation of a first actuator and a second actuator, thereby causing movement of a pair of tissue retainers; and 5) actuation of an insertion actuator, thereby causing one or more of a plurality of fasteners to be released via a fastener delivery mechanism. Attached Figure Description

[0032] In the accompanying drawings, the same reference numerals generally refer to the same parts in all different views. When parts are symmetrical, the numbered features will be labeled "a" on the left and "b" on the right, but in the text, these symmetrical elements may be identified as "a, b", even if only one part is seen in a particular drawing. Moreover, the drawings are not necessarily drawn to scale, but generally focus on illustrating the principles of the invention.

[0033] Figure 1 A three-dimensional view of the incision in the skin is shown.

[0034] Figure 2 yes Figure 1 Enlarged cross-sectional view of one side of the incision taken along line 2-2 when it is lifted by tweezers according to the prior art.

[0035] Figure 3 A cross-sectional view of an incision fixed by suturing according to the prior art is shown.

[0036] Figure 4 An embodiment of the invention is shown, near a patient with an incision suitable for closure by surgical fasteners.

[0037] Figure 5A is a perspective view of an embodiment of the present invention.

[0038] Figure 5B is a perspective view similar to Figure 5A, showing the suture insertion device being removed / replaced.

[0039] Figures 6A, 6B, 6C, and 6D illustrate various positions of embodiments of the present invention relative to the incision being closed.

[0040] Figure 7 An exploded view of an embodiment of the suture insertion device portion of the present invention is shown to reveal the internal components.

[0041] Figure 8The diagram illustrates the state that the internal components of a suture insertion device according to an embodiment of the present invention may present when it is separated from other components of the system.

[0042] Figure 9 It shows Figure 8 The components shown demonstrate their position when ready to be inserted into a fastener.

[0043] Figure 10 This is a graphical representation of data obtained from measuring forces in various mechanisms similar to, and including, embodiments of the present invention.

[0044] Figure 11 A cross-sectional view of one side of the cut is shown when it is positioned for fastener insertion according to an embodiment of the invention.

[0045] Figures 12A, 12B, and 12C show three locations of an embodiment of the invention to demonstrate how the design of the delivery mechanism housing can reduce the variability of fastener positions.

[0046] Figure 13 This is a graphical representation of data obtained by measuring the forces exerted on fasteners when they are pushed into different tissues according to the present invention.

[0047] Figure 14 The timing control diagrams used to control the sequence of steps described in Figures 6A, 6B, 6C, and 6D are shown.

[0048] Figure 15 A cross-sectional view of a cut secured by a bioabsorbable fastener according to the present invention is shown.

[0049] To fully understand this disclosure, reference should be made to the following detailed description, including the appended claims, in conjunction with the foregoing drawings. Although this disclosure has been described in conjunction with exemplary embodiments, it is not intended to be limited to the specific forms listed herein. It should be understood that various omissions and equivalent substitutions are contemplated, as these may indicate or demonstrate advantages. Detailed Implementation

[0050] By way of summary, this invention relates to an automated skin closure system that overcomes the limitations of current methods and devices by operating with minimal intervention from a skilled operator and without the need for a surgeon. The system enables rapid deployment of bioabsorbable fasteners to achieve a secure skin closure with minimal complications and minimal scarring. The system can automate the execution of skin closure for a wide range of surgical procedures.

[0051] refer to Figure 1The incision 50 to be closed is located in the tissue having an outer skin surface 53. For the purposes of this specification, "upward" or "vertical" means a direction generally perpendicular to the skin surface 53, even if the surface is curved or oriented in another direction. Human skin consists of multiple layers and can... Figure 2 As seen in the image, it shows... Figure 1 A cross-sectional view taken along line 2-2 from one side 51a of the incision. The outermost layer, the epidermis 56, is mainly composed of dead cells. Below it is the dermis 59 (a thin layer of tough living tissue), followed by the subcutaneous layer 62.

[0052] Figure 2 This demonstrates needle insertion according to a retractable subcutaneous suture technique. Forceps 12 are used to lift one edge of the incision, and a curved needle 20, connected to bioabsorbable suture material 22, is inserted a distance “S” backward from the cut edge. The needle is held by a needle holder (not shown) and guided by the surgeon to enter and exit the dermis 59. The surgeon typically begins from the other side 51b, inserting the needle from the deeper layers to the superficial layers, as... Figure 2 This is accomplished by moving from the superficial to the deep layers. This allows the cut ends of the suture material and the knots to remain deep within the incision, as shown. Figure 3 As shown. The degree of eversion of the "C" is determined by the distance the needle retracts from the cut edge and how small / tight the 70 loop knot is; these variables depend on the surgeon's skill, experience, and judgment. Arranging needles and knots with such stringent precision is time-consuming and carries the risk of needlestick injuries.

[0053] As will be described in more detail herein, the system of the present invention automatically places bioabsorbable sutures below the skin surface to engage the dermis on substantially opposite sides of the incision so that the incision remains closed with optimal eversion.

[0054] Figure 4 An embodiment of an automated skin closure system 100 is shown, which is mounted on a robotic arm 110 similar to a mechanism known to those skilled in the art. To use the system, the robotic arm is moved to a position that allows access to a patient 10 whose outer skin surface 53 has an incision 50 suitable for closure by surgical fasteners.

[0055] Figure 5aAn embodiment of an automated skin closure system 100 is shown, comprising an actuator tower 150, a distal arm 160, and a proximal arm 170. The actuator tower 150 houses an electric actuator and is configured to receive a replaceable suture insertion device 200. The distal arm 160 supports a first gripper 220a and includes at least one vision system 250a. The proximal arm 170 supports a second gripper 220b and a third gripper 220c and houses an additional vision system 250b. The vision systems 250a and 250b may include one or more cameras, a surface measurement laser with associated detectors, and an integrated circuit and microprocessor for executing instructions (including running analysis software) to guide the operation of the automated skin closure system.

[0056] More specifically, system 100 may include a programmable controller operatively coupled to various components of system 100 (including vision systems 250a, 250b) and configured to perform electromechanical control on the various components based on inputs received via vision systems 250a, 250b and / or inputs from other sensors associated with system 100 (e.g., force sensors, proximity sensors, etc.).

[0057] For example, the programmable controller can be operatively coupled to at least one of the following: actuator tower 150 and its components, distal arm 160 and its components, proximal arm 170 and its components, first gripper 220a and its components, second gripper 220b and its components, third gripper 220c and its components, suture insertion device 200 and its components, and each of vision systems 250a and 250b. As described in more detail herein, the controller can be configured to perform electromechanical control (including actuation of one or more components of the suture insertion device) on one or more of the actuator tower, grippers, and suture insertion device in response to inputs received via one or more sensors (including inputs from the vision system) to enable autonomous or semi-autonomous delivery of bioresorbable fasteners from the suture insertion device to secure opposite sides of an incision and effectively close the incision and promote healing.

[0058] The programmable controller typically includes a hardware processor coupled to a non-transitory computer-readable storage medium containing instructions that the processor can execute to enable the controller to perform electromechanical control over various components of system 100. The controller includes one or more non-transitory computer-readable media for storing one or more computer-executable instructions or software for implementing exemplary embodiments. The non-transitory computer-readable media may include, but is not limited to, one or more types of hardware memory, non-transitory tangible media (e.g., one or more magnetic storage disks, one or more optical disks, one or more solid-state drives), etc. For example, the memory may store computer-readable instructions or software and computer-executable instructions or software for implementing / actuating components of system 100 (including the suture insertion device 200 or portions thereof). The controller also includes a configurable and / or programmable processor (e.g., a central processing unit, a graphics processing unit, etc.) and associated cores (e.g., in the case of a computer system with multiple processors / cores) for executing the computer-readable instructions or software and computer-executable instructions or software stored in the memory, as well as other programs for controlling the system hardware.

[0059] Figure 5b The diagram illustrates the state in which the suture insertion device 200 may be separated from the actuator tower 150 when it is being replaced. The suture insertion device 200 is a "single-use" or "disposable" component and is designed to be replaced in each surgical procedure. The distal arm 160 extends to the "reload" position to provide the user with access to replace the device 200. The operator guides the device 200 for replacement into the appropriate position so that the tapered pin on the distal end of the actuator within the actuator tower 150 is inserted into the corresponding hole in the push rod (e.g., ...). Figure 9 (as shown) is used for loading. Once inserted, a proximity sensor (not shown) within the actuator tower 150 is configured to confirm correct positioning, and the controller activates a locking tab to secure the suture insertion device 200 in place.

[0060] Figure 6a , Figure 6b , Figure 6c and Figure 6d The operational position of the automated skin closure system 100 relative to the outer skin surface 53 and the incision 50 is shown. For orientation, the left side of the figure will be referred to as the distal end of the incision. Preferably, the incision is first sutured at the distal end, followed by insertion towards the right or proximal end.

[0061] As a first step, such as Figure 6aAs shown, the vision system 250a is activated to determine the location of the incision. The boundaries of the incision can be identified by conventional handwriting markings, adhesive points, or other digital recognition methods known in the art. Once the boundaries of the incision are confirmed, the controller aligns the automated skin closure system 100 with the longitudinal axis of the incision. The controller then uses feedback from the vision system to guide the grippers to engage with the tissue. The first gripper 220a clamps the tissue at the apex at the distal end of the incision, and the second gripper 220b and the third gripper 220c clamp an edge of the incision at approximately 50-60 mm from the apex. The grippers 220a, 220b, and 220c lift the tissue to a height above the plane of the outer skin 53. The distance the edges are lifted is controlled by real-time analysis of the feedback from the grippers, such that a maximum height of 10 mm or a lifting force of 5 lbs (whichever is greater) is achieved at each gripper. As the tissue edges are lifted and separated posteriorly to form a "V" shape, the injector 90 is lowered between the tissue edges and moved to a position 5 to 10 mm from the distal apex.

[0062] Figure 6b The automated skin closure system 100 is shown in its completed connection. Figure 9 The state that may occur after the described series of steps. Tissue retainers 88a and 88b move to their closed position, and suture insertion device 200 applies fasteners, thereby simultaneously gripping opposite sides of the incision.

[0063] Figure 6c An automated skin closure system 100 is shown after fasteners are applied and tissue retainers 88a, 88b are released. The suture insertion device 200 is guided by a controller to move distally a predetermined distance “L” while holding the inserter 90 between tissue edges 51a, 51b. The distance “L” is typically between 7 mm and 10 mm, but can be larger or smaller based on user input and / or information specific to the procedure or patient. After moving the distance “L”, the tissue retainers 88a, 88b briefly clamp the tissue edges 51a, 51b to allow the grippers 220a, 220b, 220c to release and move.

[0064] Figure 6dThe diagram illustrates the state the automated skin closure system 100 may present when the second fastener is deployed. The grippers 220a, 220b, and 220c have moved the same distance "L" in coordination with the movement of the suture insertion device 200 and are shown re-grasping the tissue edges 51a and 51b. This positions the first gripper 220a at the site where the first fastener was just deployed. Note that, apart from the grippers and suture insertion device both moving longitudinally along the axis of the incision by a distance "L", the relative positions of the grippers 220a, 220b, 220c and the suture insertion device 200 are... Figure 6b The same applies as in the previous section. At this point, the tissue retainers 88a and 88b are closed and the fasteners are inserted.

[0065] Repeat steps 6b to 6d of applying the fastener, releasing, moving, and re-grasping until the incision is closed. Once the insertion point is within 30 mm of the proximal end of the incision, the graspers 220b and 220c furthest from the apex will disengage and move upward / outward out of the surgical field of view. For incisions shorter than 30 mm, the graspers 220b and 220c are primarily used to separate the sides of the incision to allow the inserter 90 to be easily positioned between the raised edges 51a and 51b.

[0066] Figure 7An exploded view of an embodiment of the suture insertion device 200 is shown to reveal the internal components. The suture insertion device includes a right housing 212 and a left housing 213, which can be assembled together to form a housing that orients and constrains other components. In the final assembly, a fastener delivery mechanism 300 remains within the assembled housing and is registered in place by a balancing pin 342, which is located in the right receiving portion 343 and the left receiving portion 344 when the housing is assembled. Each time the actuator in the actuator tower operates the plunger needle assembly 145, the fastener delivery mechanism 300 delivers fasteners one by one from a cassette (not shown) containing a plurality of fasteners. In some embodiments, the mechanical elements of the fastener delivery mechanism 300 are similar to those described in Rogers and interact with the fasteners in substantially a similar manner. The suture insertion device 200 also includes tissue retainers 88a and 88b, which are primarily registered in the housing via tissue retainer pivot pins 350a, 350b, 350c, and 350d, located in right leg receivers 352a and 352b and left leg receivers 352c and 352d, respectively, for the right and left tissue retainers. Each tissue retainer 88a and 88b is rotatably coupled to the distal end of push rods 320a and 320b, which apply force to the tissue retainer by contacting tissue retainer push rods 355a and 355b. Connectors 358a and 358b located at the proximal ends of push rods 320a and 320b are configured to mate with actuators (not shown) in actuator tower 150.

[0067] Figure 8The internal components of the suture insertion device are shown in a state that may occur when it is separated from the right and left housings. Force from actuators (not shown) is applied to connectors 358a, 358b located proximal to the push rods 320a, 320b to cause rotation of tissue retainers 88a, 88b. The tissue retainers include clamping elements 87a, 87b that press against the outer surface of the tissue edge to clamp the tissue onto clamping rails 92a, 92b. As the tissue retainers move to position the tissue for fastener insertion, it is crucial that the tissue edge is presented equally on both sides of the device to achieve reliable bilateral capture of the dermis. Even a slight difference in size between the left and right sides can cause one leg of the fastener to miss the dermis. This can happen, for example, if the degree of dissection on one side is different or if scar tissue on one side is removed without removing scar tissue on the other side. One embodiment of the invention addresses this imbalance by providing a centering mechanism that ensures equal spacing between the fastener and the legs on each side of the incision. In this embodiment, the fastener delivery mechanism 300 is rotatably attached at its proximal end to the housing of the suture insertion device 200 using a cylindrical balancing pin 342. Any initial imbalance of forces applied from one side to the other is offset by the movement of the delivery mechanism as the clamps 87a, 87b press the tissue against the clamping rails 92a, 92b, until these forces are balanced. In this way, the tracks of the fastener delivery mechanism and the guide insertion device are centrally located between the tissue retainers / legs.

[0068] Figure 9 The components of the suture insertion device shown are the same as those of the previous ones. Figure 8The same as shown in the diagram is now presented in the position it takes when ready to insert the fastener. Tissue retainers 88a, 88b are connected to push rods 320a, 320b, which are operatively coupled to actuators 360a, 360b via push rod connectors 358a, 358b. The driving force provided by actuators 360a, 360b is aligned with the longitudinal axis of the push rods, causing the tissue retainers to rotate and move about tissue retainer pivot pins 350a, 350b, 350c, 350d until they contact stops 340a, 340b located at the distal end of the fastener delivery mechanism 300. Contact with stops 340a, 340b prevents further movement of the tissue retainers 88a, 88b, causing the front surfaces of the legs 89a, 89b (i.e., where the legs contact the outer surface of the skin) to position to form a gap of a predetermined size. To ensure the clearance dimensions are maintained during fastener insertion, actuators 360a and 360b continue to move slightly after tissue retainers 88a and 88b contact stops 340a and 340b. Force and position sensors on the actuators are used as feedback to control the amount of movement. Equal forces are applied to the right push rod 320a and left push rod 320b to achieve a predetermined force and / or distance, providing sufficient stiffness to prevent counter-rotation of the tissue retainers 88a and 88b. We have determined that a stiffness greater than 20 lbf / mm (i.e., a force gradient preventing movement of the front surfaces of the tissue retainers / legs 89a and 89b) is required to achieve reliable positioning of the fastener in the dermal tissue. In one embodiment, sufficient force is applied to bend the push rods (e.g.,...). Figure 9 (As indicated by the curved arrow in the diagram) to obtain the required stiffness. The push rods 320a and 320b are made of a strong and elastic material, such as 30% glass-filled nylon, so that when the push rods are bent, they have a restoring force that can prevent the tissue retainers 88a and 88b from rotating in the opposite direction.

[0069] Those skilled in the art can employ alternative mechanical linkages to move the tissue retainer. The alternative linkages can be tested by measuring the force required to separate the front surfaces of the legs 89a, 89b to determine if they possess the stiffness required by the present invention. Stiffness is the derivative of the force-displacement curve. Figure 10 The measurements show the force required to increase the gap between the front surfaces of legs 89a and 89b when the mechanism is positioned for applying fasteners. Mechanism D represents the invention and achieves a stiffness of almost 40 lbf / mm at a displacement of 0.4 mm (circled area in the graph).

[0070] Figure 11A cross-sectional view of one side 51b of the incision positioned for fastener insertion is shown. The edge of the incision is secured by clamping between clamping member 87b and clamping rail 92b. One leg 82b of fastener 80 is shown mounted on needle 65b and carried or pushed by insertion device 146. An actuator (not shown) within the actuator tower is operatively coupled to move insertion device 146 along an axis substantially perpendicular to skin surface 53. To release the fastener, the actuator is advanced distally to move all components together: insertion device 146, fastener 80, and needle 65b. This movement causes the tip of needle 65b to penetrate subcutaneous tissue 62 and the dermis 59 of that tissue. The “S” shown in the figure represents the distance between the point where the fastener pierces the tissue and the cutting edge 51b. The meaning of “S” is... Figure 2 The same meaning applies to the retracted subcutaneous suture technique shown. The distal surface of the prong 89b of the tissue retainer presses against the outer surface of the skin and moves to a predetermined position relative to the path of the fastener. We have determined that the distance “D” between the outermost surface of the fastener prong 82b and the distal surface of the prong that contacts the outer surface of the skin 89b should not exceed 0.27 mm, and should generally be 0.17 mm. The dermis, due to its toughness, becomes the target for the insertion of the fastener, located just below the epidermis 56. Because the epidermis is very thin and in direct contact with the prong portion of the tissue retainer, changes in the epidermis will only cause a displacement of a fraction of a millimeter in the dermal tissue. Therefore, by positioning the outer surface of the skin at a distance “D” from the outermost surface of the fastener (where “D” is between 0.17 mm and 0.27 mm), the fastener will engage the dermis, regardless of the thickness of the skin tissue and its layers.

[0071] refer to Figure 11 The discussion emphasizes the importance of accurately guiding the fastener to the point where it pierces the tissue. (Reference) Figure 8 and Figure 9 The inventive elements of the present invention described herein ensure precise placement of the tissue, but the fastener 80 must also be placed with similar precision. Figures 12a to 12cThree locations of an embodiment of the invention are shown to illustrate how the design of the delivery mechanism can reduce the variability of fastener position. The components of the fastener delivery mechanism 300 are housed in two parts: a left delivery mechanism housing 147 and a right delivery mechanism housing 149. When these two housings are assembled, a guide rail is formed in which the plunger needle assembly and insertion device 146 (not shown) slide to deliver one fastener at a time. With conventional design, the rail would be wider than the width of the insertion device carrying the fastener to facilitate sliding. This sliding space (typically + / - 0.1 mm) can also include tolerances for part variations (typically + / - 0.06 mm). The end result can allow for significant variations in the fastener's path compared to the very small target the fastener must hit. The present invention reduces this variation by making the guide rail no wider than the insertion device and the fastener; in fact, by making the guide rail slightly narrower. To avoid high friction, the left delivery mechanism housing 147 and the right delivery mechanism housing 149 are assembled together with a small gap 148 between them at the distal end, such as... Figure 12a As shown. At the start of insertion, the insertion device with fasteners easily slides in the guide rail due to the movement clearance provided by gap 148. As the fasteners continue to move and reach exit 290, the retaining members 88a, 88b contact the stops 340a, 340b and force gap 148 to decrease to zero (see Figure 148). Figure 12b This means that the fastener is guided via line-to-line contact, which minimizes positional uncertainty as the fastener passes the exit and penetrates the tissue. The increased friction encountered in the final few millimeters of travel during insertion is minimal compared to the force required to penetrate the tissue. Therefore, the actuator force is able to deliver the fastener into the tissue with line-to-line guiding accuracy (see...). Figure 12c To complete the insertion cycle, the insertion actuator of the control insertion device retracts a short distance to remove the needle from the tissue. Then, the actuators of the control push rods 320a and 320b reverse, immediately releasing the force exerted on the stops 340a and 340b by the tissue retainers 88a and 88b. The release of the clamping force on the stops 340a and 340b allows the gap 148 to open, thereby returning the device to its original position. Figure 12a The configuration shown. In the case of re-establishing the gap, the insertion device can be easily retracted by inserting the actuator to prepare for applying the next fastener.

[0072] Applying a fastener to the tissue involves another dimension that must be controlled to achieve reliable automated skin closure. This dimension is the distance the fastener is pushed before the actuator reverses and withdraws the insertion device. Fasteners of the type taught by Danielson have a front surface area much larger than the needle. If the fastener has barbs, as in one embodiment of the invention, the surface area is further increased. As the needle and fastener enter the tissue, the force required for penetration increases with each increase in front surface area. This causes the tissue to stretch away from the insertion device, thus requiring the actuator to push further. At a certain distance, which varies depending on the characteristics of the tissue, the fastener / barbs penetrate the dermis. If the actuator delivering the fastener stops short of this distance, it can result in poor fastener engagement and unsatisfactory closure.

[0073] One embodiment of the invention adjusts the distance at which the fastener is pushed based on the nature of the tissue. Figure 13 This illustrates the force exerted by the actuator at various distances when a fastener is pushed into tissues with different properties. Note as... Figure 13 The graph shows two "bumps" at approximately 4 mm and 6 mm distances on the curve of the alternative materials. The first bump occurs when the tissue expands to accommodate the front end of the fastener due to needle entry. The second bump (circled) occurs upon barb entry. These "bumps" are due to the elastic properties of skin tissue, which is initially stretched and then springs back once the fastener penetrates. Note that for each tissue material indicated by the dashed circle, the penetration distance is significantly greater for porcine elastic tissue. Conversely, as this experiment shows, the penetration distance for dense porcine tissue is shorter, but requires significantly greater force. This invention utilizes... Figure 13 Similar data analysis is used in real time to control the distance the fastener is pushed. Changes in the slope of the force curve in the area where penetration is expected are used as a signal to stop and reverse the actuator. Therefore, in Figure 13 In the experimental data shown, the actuator will drive the insertion device to distances of 13 mm, 9.5 mm, and 7.5 mm for elastic tissue, dense tissue, and replacement tissue, respectively. Those skilled in the art can implement further control improvements, including limiting the distance for safety purposes, detecting errors, and providing the expected distance based on surgical site and patient demographic information that can be provided to the automated system.

[0074] Figure 14 Demonstrates control Figures 6a to 6d The timing control chart for the sequence of steps described in the diagram. The x-axis is marked with arbitrary time intervals. Figure 6a and Figure 6b The initial steps shown are displayed in the range 0-55. The range 60-115 shows... Figure 6c and Figure 6dThe steps are shown. The chart utilizes the information displayed. Figure 14 The labels A, B, C, and D at the top indicate the location of the item. Figure 6a , Figure 6b , Figure 6c , Figure 6d The exact time of capture. The dashed segments marked "Tissue Holder - Left and Right" at intervals 20-25 and 85-90 represent additional movement of the tissue holder, which, when combined with... Figure 9 The feedback from force and position sensors is variable. The dashed segments labeled "insertion device" at 30-35 and 90-95 indicate the additional distance the fastener is pushed, which, when combined with... Figure 13 The feedback is variable. The line labeled “Introducer - Longitudinal Position” represents the sequential insertion of fasteners, starting at the apex of the cut and moving sequentially as fasteners are deployed. After each insertion, when the insertion device is withdrawn (see, for example, the insertion device line at 55), the distal and proximal arms move cooperatively to reposition the actuator tower 150, thereby moving the introducer to the next fastener insertion position (at time interval 60). At time interval 65, the graph illustrates the movement of the tissue retainer, which applies partial / brief clamping, allowing the first, second, and third grippers to be repositioned. Once repositioned, the tissue retainer is fully closed, and the next fastener is subsequently inserted by the insertion device (time intervals 85-100). The system reaches a stopping point after each insertion (e.g., at time interval 115). If no more fasteners are needed, the actuator tower 150 is lifted and the system is removed. If additional fasteners are needed, the system restarts at 55 for repetition.

[0075] Figure 15 A cross-sectional view of the fastener after insertion according to an embodiment of the invention is shown. A bioabsorbable fastener 80, having two legs 82a, 82b connected by a flexible connecting bridge 85, engages with dermal tissue 59 to... Figure 3 The back-suture technique shown maintains the incision edges closed in essentially the same way. Dimension "B" is the length of the connecting bridge 85, which plays a crucial role in determining the eversion amount "C". The eversion amount "C" is determined using the formula C = S - B / 2, where S is... Figure 11 The shown back distance, and B is Figure 15 The length of the connecting bridge shown is in millimeters for all variables. Dimension “S” may vary slightly depending on the amount of tissue gripped during clamping, but this is monitored by the vision system after each fastener insertion and can be adjusted to minimize variation. Uniform flaring “C” is achieved by minimizing variation in “S” and using fasteners with a known dimension “B”.

[0076] As used in any embodiment herein, the terms “controller,” “computing system,” “computing device,” and “module” can refer to software, firmware, and / or circuitry configured to perform any of the foregoing operations. Software can be embodied as software packages, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware can be embodied as hard-coded (e.g., non-volatile) code, instructions, or instruction sets and / or data in a memory device. As used in any embodiment herein, “circuitry” can include, for example, hard-wired circuitry systems, programmable circuitry systems (such as a computer processor including one or more individual instruction processing cores), state machine circuitry systems, and / or firmware storing instructions executed by the programmable circuitry system. Modules can be collectively or individually embodied as circuitry systems forming part of a larger system, such as integrated circuits (ICs), system-on-a-chip (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc.

[0077] Any of the operations described herein can be implemented in a system comprising one or more storage media on which instructions, individually or in combination, are stored, which, when executed by one or more processors, perform the methods. Here, a processor may include, for example, a server CPU, a mobile device CPU, and / or other programmable circuit systems.

[0078] Furthermore, it is intended that the operations described herein can be distributed across multiple physical devices, such as processing structures located in more than one different physical location. Storage media can include any type of tangible media, such as any type of disk (including hard disks, floppy disks, optical disks, optical disc read-only memory (CD-ROM), rewritable optical disc (CD-RW), and magneto-optical disks), semiconductor devices (such as read-only memory (ROM)), random access memory (RAM) (such as dynamic and static RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state drives (SSDs), magnetic cards or optical cards, or any type of media suitable for storing electronic instructions. Other embodiments can be implemented as software modules executed by a programmable control device. Storage media can be non-transitory.

[0079] As described herein, the various embodiments can be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, etc.), integrated circuits, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field-programmable gate arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chipsets, etc.

[0080] Throughout this specification, references to "an embodiment" or "an embodiment" mean that at least one embodiment includes a particular feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0081] The term "non-transient" should be understood to exclude only the propagating transient signal itself from the scope of the claims, without waiving the rights to all standard computer-readable media that are not solely propagating transient signals themselves. In other words, the terms "non-transient computer-readable medium" and "non-transient computer-readable storage medium" should be interpreted as excluding only those types of transient computer-readable media that are deemed outside the scope of the patentable subject matter under 35 USC § 101 in In Re Nuijten.

[0082] The terms and expressions used herein are for descriptive purposes and not for limitation, and in using such terms and expressions, it is not intended to exclude any equivalents of the features (or portions thereof) described and illustrated, and it should be recognized that different modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0083] Incorporation

[0084] Throughout this disclosure, other sources, such as patents, patent applications, patent publications, journals, books, papers, and web content, have been referenced and cited. All such sources are hereby incorporated in their entirety for all purposes.

[0085] equivalent

[0086] In addition to those shown and described herein, various modifications to the invention and many other embodiments thereof will become apparent to those skilled in the art from the entire contents of this document (including references to scientific and patent literature cited herein). The subject matter of this document contains important information, examples, and guidance that can be adapted for practice in the various embodiments of the invention and their equivalents.

Claims

1. An automated system for closing one or more incisions or wounds in a patient, the system comprising: Mobile platform; A suture insertion device releasably coupled to a portion of the movable platform, the suture insertion device being configured to deploy a bioabsorbable fastener to close an incision or wound in a patient's tissue, the suture insertion device comprising: A body comprising a pair of tissue retainers positioned adjacent to a distal end of the body and operably coupled to a first actuator and a second actuator associated with the movable platform, each of the first and second actuators being configured to move a corresponding tissue retainer to effectively clamp and fold an edge of the incision or wound, thereby preparing for the application of a fastener; and A fastener delivery mechanism, operatively coupled to an insertion actuator associated with the movable platform and configured to deliver one or more of a plurality of bioabsorbable fasteners, wherein the fastener delivery mechanism comprises: An insertion device comprising one or more insertion pins, the insertion device being guided within a track and configured to move in response to movement of the insertion actuator, such that the one or more insertion pins releasably engage and release each of the plurality of fasteners in a sequential manner in response to repetitive movement of the insertion actuator; An introducer, positioned at and extending from the distal end of the fastener delivery mechanism, the introducer being configured to directly contact the opposing edge of the wound or incision and having an opening through which the fastener exits the distal end of the introducer during delivery; and A pair of stop surfaces configured to directly contact a corresponding tissue retainer of the pair of tissue retainers, thereby positioning the outer skin surface of each edge of the incision or wound at the location of the opening relative to the distal end of the inserter; and A controller operably coupled to the movable platform and the suture insertion device, the controller including a hardware processor coupled to a non-transitory computer-readable storage device containing instructions that the processor can execute to enable the controller to perform electromechanical control on the following: The movement of the platform causes a corresponding movement of the suture insertion device relative to the incision or wound; Actuation of the first actuator and the second actuator thereby causes movement of the pair of tissue retainers; and Actuation of the insertion actuator causes one or more of the plurality of fasteners to be released via the fastener delivery mechanism.

2. The system according to claim 1, wherein, The controller is programmed to coordinate the movement of the pair of tissue retainers until each tissue retainer contacts the corresponding stop surface with substantially the same predetermined force.

3. The system according to claim 2, wherein, The controller is further programmed to sequentially actuate the insertion actuator, thereby actuating the fastener delivery mechanism to deliver one of the plurality of fasteners to the distal end of the inlet at a controlled distance from the opening, and subsequently return the first and second actuators and the insertion actuator to their initial positions to prepare for the release of additional fasteners.

4. The system according to claim 3, wherein, The controlled distance the fastener delivery mechanism moves relative to the distal end of the inlet is determined by real-time analysis of the force applied by the insertion actuator.

5. The system according to claim 2, wherein, The predetermined force in contact between each tissue retainer and the corresponding stop surface is between about 8 lbf and about 15 lbf.

6. The system according to claim 2, wherein, The predetermined force when each tissue retainer contacts the corresponding stop surface provides sufficient resistance to prevent reverse movement of each tissue retainer.

7. The system according to claim 6, wherein, The resistance to the reverse motion is greater than approximately 20 lbf / mm.

8. The system according to claim 1, wherein, The track used to guide the insertion device is movable relative to the pair of tissue retainers.

9. The system according to claim 8, wherein, The pair of tissue retainers are configured to allow the track to move in response to a force applied to the inlet, such that the track is substantially centered between the pair of tissue retainers.

10. The system according to claim 1, wherein, The opening in the introducer through which the bioabsorbable fastener passes is configured to adjust its size during and after fastener placement.

11. The system according to claim 10, wherein, The opening is configured to change from a first size when the fastener moves within the opening during deployment to a different second size after the fastener has been deployed. In the first size, the sides of the opening directly contact the fastener. In the second size, the opening is larger than the first size.

12. The system of claim 1, further comprising one or more tissue grippers operably coupled to the movable platform and configured to engage patient tissue and lift the edges of the incision or wound to temporarily position each edge on opposite sides of the suture insertion device and adjacent to a corresponding tissue retainer on a given side of the suture insertion device.

13. The system according to claim 12, wherein, The controller is operatively coupled to the one or more tissue grippers and configured to perform electromechanical control on the one or more tissue grippers.

14. The system according to claim 13, wherein, The controller is configured to control the opening and closing of the grippers of each corresponding tissue gripper and the movement of the one or more tissue grippers.

15. The system according to claim 13, wherein, The system includes three tissue grippers.

16. The system according to claim 14, wherein, The first tissue gripper is configured to clamp tissue at the apex of the distal end of the incision or wound, and the second and third tissue grippers are configured to clamp the corresponding opposite edges of the incision or wound closer to the proximal end.

17. The system of claim 13, further comprising a camera positioned to capture one or more images of a surgical field of view, including capturing one or more images of tissue surrounding the incision or wound, the one or more tissue grippers, the edges of the incision or wound, and the inserter of the suture insertion device.

18. The system according to claim 17, wherein, The controller is operatively coupled to the camera and configured to receive image data from the camera, and based on analysis of the image data, the controller is configured to perform electromechanical control on at least one of the following: The movement of the one or more tissue grippers; Control of the opening and closing of the grippers of a given tissue gripper; The movement of the platform causes a corresponding movement of the suture insertion device relative to the incision or wound; The actuation of the first actuator and the second actuator causes movement of the pair of tissue retainers; as well as Actuation of the insertion actuator causes one or more of the plurality of fasteners to be released via the fastener delivery mechanism.

19. The system according to claim 1, wherein, The suture insertion device is a disposable device.

20. The system according to claim 19, wherein, The movable platform is configured to receive and releasably hold interchangeable suture insertion devices.

Images