Suturing System comprising Elastic-Based Deployable Insertion Staple

Abstract

The present invention relates to a suturing system comprising an elastic-based unfolding insertable staple, and provides a hybrid insertion mechanism that minimizes tissue damage and pain by utilizing the elastic restoring force of the staple itself instead of the conventional forced bending (Cinching) method. The suturing system according to the present invention includes an elastic staple (100) capable of elastic deformation and restoration; an expansion guide member (310) positioned on the downward path of the staple to expand the leg gap; and a drive system that completes insertion into the tissue by combining the elastic restoring force (F elastic) of the staple and the insertion force (F driver) of a driver. In particular, the expansion guide member (310) is configured as either an actively controlled movable wedge (312, 313) or a fixed expansion guide (314) fixed to the inner wall of a magazine, thereby providing convenience and cost-effectiveness of operation. Additionally, a diagonal overlapping array (332) for high-density stacking of staples and an offset magazine structure (621, 622) are adopted to secure the operator's field of view. Furthermore, it is characterized by being combined with a pressure support projection (510) for self-removal and an adhesive auxiliary material (530, 540) that assists in wound closure, allowing for a wide range of implementations from hospital rapid-fire devices to home self-care systems.

Description

Technology Field

[0001] The present invention relates to a suturing system comprising an elastic-based deployable insertable staple for suturing or closing the skin, subcutaneous tissue, and surgical incisions of humans and animals. More specifically, the invention provides a hybrid insertion principle that departs from the conventional method of forcibly plastically deforming (cinching) a staple leg through external force for insertion, wherein a staple placed in a pre-elastically deformed state is deployed by a driving mechanism immediately before insertion, and then self-induced insertion into the tissue using an elastic restoring force that attempts to return to its original shape, with the auxiliary insertion force of a driving body synchronized and combined with this. Furthermore, the invention relates to a high-efficiency suturing system comprising a stepwise driving mechanism for precisely controlling this insertion mechanism, as well as a multi-suturing system based on the mode of operation, in addition to single-stroke suturing. Background Technology

[0002] Conventional medical staplers are based on a structure that penetrates and inserts straight or double-ended staples into skin and tissues by applying high-speed pressure to forcibly bend (cinching). This method has the following structural limitations.

[0003] 1. Excessive pressure and pain at the moment of insertion: As the plastic deformation and insertion of the staple occur simultaneously, a large intrusion force is instantaneously transmitted to the tissue, causing significant pain and making tissue damage likely.

[0004] 2. Skin overlap and wrinkling: There is a problem where the skin folds asymmetrically or wrinkling occurs due to slight differences in the insertion direction or skin tension.

[0005] 3. Instability in thin skin: In cases where the skin is thin, such as in small animals, children, or plastic surgery, the length of the staple leg is relatively excessive, causing the bridge to lift or the fixation to become unstable.

[0006] 4. Structural limitations of suturing speed: Most conventional staplers can only insert one staple per operation, so dozens of repeated operations are required for large incisions, and the instrument's volume increases when loaded in large quantities, interfering with the operator's hand movements.

[0007] Meanwhile, adhesive wound closure bandages and tape-type suture aids have limitations, such as reduced adhesive strength due to moisture or bodily fluids and insufficient mechanical resistance.

[0008] Therefore, there is a continuous technical demand for a suturing system with a new mechanism that minimizes pain and tissue damage, enables precise insertion even in thin tissues, ensures operator convenience, and allows for the rapid application of a large volume of staples.

[0010] (Patent Document 1) KR 20-0213986 Y1

[0011] (Patent Document 2) KR 10-0646762 B1

[0012] (Patent Document 3) KR 10-1960580 B1

[0013] (Patent Document 4) KR 10-2608073 B1 The problem to be solved

[0015] The objective of the present invention is to provide an elastic-based deployable insertable staple and a suturing system that can provide a new insertion principle combining elastic restoring force and auxiliary insertion force without forcibly bending the staple with an external force, precisely control the insertion depth and insertion force through bridge deformation and leg spacing control, provide a universal suturing platform applicable to existing metal staples and non-metal staples, and provide a highly scalable suturing system usable in both surgical and home environments. means of solving the problem

[0016] To achieve the above objective, the elastic-based deployable insertable staple and the suturing system according to the present invention comprises the following technical features:

[0017] 1. A staple (100) made of a material having elastic restoring force and comprising an elastic bridge (110) and a plurality of legs (120) extending downward from both ends of the bridge;

[0018] 2. An elastic deformation structure in which the gap between the legs (120) is expanded as the bridge (110) is temporarily deformed by an external force (driver or wedge);

[0019] 3. A structure that induces the leg (120) to converge and be restored in the tissue insertion direction by the elastic restoring force stored in the bridge (110) at the same time as the above external force is removed;

[0020] 4. A stepwise insertion mechanism in which a driving body (driver) provides a final auxiliary insertion force in the same direction as the elastic restoration direction to fully seat the staple within the tissue.

[0022] The staple insertion mechanism according to the present invention has a hybrid insertion structure based on the resultant force of the main insertion force and the auxiliary press-in force due to elastic restoration as follows.

[0023] (1) Main insertion force: Contraction kinetic energy of the leg (120) due to the elastic restoring force of the bridge (110),

[0024] (2) Final auxiliary insertion force by lowering of the drive body (210): Eliminates insertion incompleteness that may occur during elastic insertion alone, and at the same time disperses the sudden shock pressure transmitted to the tissue, thereby minimizing insertion pain.

[0026] The suture system according to the present invention provides three distinct deployment mechanisms as follows to control the deployment and insertion of a staple.

[0027] (1) Direct deployment method using a movable leg extension wedge (312) (see FIG. 3a)

[0028] This embodiment directly controls the elasticity of the leg by utilizing a movable leg extension wedge (312) and is driven in the following steps.

[0029] 1) Waiting and deployment phase: A single driver (210) descends with the staple (100) and waits at a position just before the skin (400). Then, when the driver applies additional pressure to the elastic bridge (110), the leg (120) is forcibly expanded outward along the inclined surface of the movable leg expansion wedge (312) positioned at the bottom, accumulating elastic energy.

[0030] 2) Elastic restoration and insertion step: As the restraint of the movable leg extension wedge (312) is released at the point when the staple is inserted into the skin (400), the leg (120) accumulates elastic restoring force ( F elastic The pressurizing force of the driver and the ) are combined and seated on the suture target (400).

[0031] (2) Active deployment method using a movable bridge deformation wedge (313) (see FIG. 3b)

[0032] This embodiment deforms the bridge through the organic operation of the movable bridge deformation wedge (313) and the split driver (210a, b, c), and is driven in the following steps.

[0033] 1) Waiting and bridge deployment phase: After the entire split driver descends and waits, the central driver (210a) descends first and presses the central part of the elastic bridge (110). At this time, the movable bridge deformation wedge (313) acts as a pivot point supporting the upper ends of both legs, causing the bridge to bend downward, and as a result, the gap between the legs (120) is deployed outward.

[0034] 2) Composite insertion and seating step: As the staple is inserted into the skin, the restraint of the movable bridge deformation wedge (313) is released, and at the same time, the left and right split drivers (210b, 210c) finally descend, and the auxiliary pressing force ( F driver Complete precise insertion by providing ).

[0035] (3) Manual deployment method using a fixed expansion guide (314) (see FIG. 3c)

[0036] This embodiment utilizes a fixed expansion guide (314) fixedly positioned inside the mechanism and uses the downward path of the staple itself as a control mechanism without a separate wedge driving mechanism.

[0037] 1) Path-based bridge deployment step: As the staple descends by the split driver (210a, b, c), the shoulder portion of the staple physically interferes with a fixed extension guide (314) fixed to the inner wall of the mechanism. Depending on the shape, the guide (314) is configured as a protruding bump type (314a), a curved rail type (314b), or a tapered block type (314c) to passively induce downward bending of the bridge.

[0038] 2) Continuous insertion and restoration step: As the staple continues to descend and passes the point where it goes beyond the constraint range of the guide (314), spontaneous elastic restoration occurs without a separate mechanical drive and is inserted into the tissue in combination with the insertion force of the driver. This minimizes the driving parts to ensure the continuity of operation and maximizes the cost-effectiveness of the disposable instrument. Effects of the invention

[0039] According to the suturing system including an elastic-based deployable insertable staple according to the present invention, the following effects are achieved.

[0040] 1. Prevention of tissue damage and dramatic reduction of pain

[0041] Through an active insertion mechanism that utilizes the elastic restoring force of the staple itself, rather than forced bending by external forces, the instantaneous compressive force applied to the tissue is dispersed. This significantly reduces insertion pain and enhances the stability of tissue healing.

[0042] 2. Aesthetic excellence through the implementation of ultra-fine staples

[0043] Conventional plastic deformation methods rely on the ductility of metals, making it difficult to maintain mechanical strength when thinned below a certain thickness; however, since the present invention utilizes the shape-retaining power of elastic materials, it is possible to manufacture staples of ultra-fine specifications. These thinned staples structurally suppress skin overlap and wrinkling phenomena, and provide extremely precise suturing results, particularly in areas requiring precision and scar minimization, such as plastic surgery suturing.

[0044] 3. Scalability as a General-Purpose Platform

[0045] Designed based on the principle of elastic deformation, it can be equally applied not only to conventional metal staples but also to staples made of various non-metallic materials, such as biodegradable polymers. It provides a universal suture platform that overcomes material mechanical limitations by dramatically expanding the range of material selection for medical purposes.

[0046] 4. Surgical efficiency and ease of operation

[0047] The offset magazine structure secures the operator's field of view and eliminates interference from hand movements, thereby reducing surgical fatigue. The simultaneous bundle insertion function based on parallel or vertical movement methods dramatically shortens suturing time compared to conventional methods.

[0048] 5. Innovation in Post-Management

[0049] User convenience is ensured so that the patient can perform low-pain self-removal by means of a removal mechanism that links the deformation of the pressure support projection (510) and the elastic bridge. Brief explanation of the drawing

[0050] Figure 1 is a front, side, and perspective view showing the basic structure and atmospheric state of an elastic staple. FIG. 2 is a planar layout showing an example of a diagonal overlapping arrangement and a gap arrangement within a staple cartridge. FIG. 3a is an operation sequence diagram showing the deployment mechanism of the leg elastic expansion method by a movable leg expansion wedge. FIG. 3b is an operation sequence diagram showing the mechanism of a bridge elastic deformation development method using a split driver and a movable expansion guide wedge. FIG. 3c is an operation sequence diagram showing the mechanism of a bridge elastic deformation development method using a split driver and a fixed extension guide. FIG. 4a is a perspective view and planar layout of a parallel action type bundle insertion device (incision parallel bundle suturing method, Offset magazine structure). FIG. 4b is a perspective view and planar layout of a vertical action type bundle insertion device (incision window vertical bundle suturing method, multi-row offset magazine structure). Figure 5 is a diagram showing the structure of a self-care clamp-type removal device and the insertion and removal mechanism through a bridge bend. Figure 6 is a detailed structural diagram of various shape variations of the staple leg and barbs and pressure protrusions. Specific details for implementing the invention

[0051] 1. Mechanical Decomposition of Insertion Force and Definition of Bundle Insertion Energy

[0052] Insertion force of a single staple (100 in FIG. 1) according to the present invention ( F total ) is composed of the following hybrid resultant force structure.

[0053] F total = F elastic + F driver

[0054] Here, F elastic It is the restoring force of elastic energy stored by the elastic deformation of the bridge (110). , F driver is a fine auxiliary press force provided by a drive unit (210 in FIG. 3a) or left and right side drive units (210b, 210c in FIG. 3b and FIG. 3c).

[0055] Furthermore, in a bundle simultaneous insertion structure in which multiple staples are inserted simultaneously (see 334 in FIG. 2 and 622 in FIG. 4b), the total system insertion force ( F total system ) can be defined as the sum of the insertion forces for each staple as follows.

[0056] F total system = Σ (F elastic i + F driver i )

[0057] (where Σ is the sum of i from 1 to n, and n is the number of staples inserted simultaneously)

[0058] This numerical structure provides the following technical advantages.

[0059] 1) Stable securing of penetration power

[0060] Despite variations in skin thickness, elasticity, and soft tissue density F driver It compensates for insufficient penetration power in real time to ensure that a certain level of penetration power is always secured.

[0061] 2) Uniformity during bundle insertion

[0062] The system delivers to each i-th staple F driver i By controlling it through an independent elastic compensation mechanism or a distributed structure, structural imbalances in insertion depth that may occur during bundle insertion are prevented.

[0063] 3) Energy efficiency

[0064] Tissue penetration is due to the restorative power of the staple itself ( F elastic In addition to ), a physical load applied by the system driver is added, enabling stable insertion of staples and bundle formation of the device.

[0066] 2. High-density loading and arrangement structure of staples (see Fig. 2)

[0067] The suturing system according to the present invention has the following arrangement principle to accumulate the maximum number of staples within a limited magazine space and to ensure that there is no inconvenience to the operator's hand movements during actual surgery.

[0068] 1) Slimming of the apparatus through diagonal leg arrangement (331)

[0069] As illustrated in the arrangement (331) of FIG. 2, the leg (120) portion of each staple is positioned so as to be inclined at a certain angle with respect to the transport direction rather than vertically. This diagonal arrangement of the legs serves to physically reduce the vertical height occupied by the legs (120) when the staples are stacked. By minimizing the vertical space occupied inside the magazine, a slimming structure can be provided that allows for the formation of a significantly thinner thickness of the instrument head portion while accommodating a large number of staples.

[0070] 2) Bridge diagonal overlapping arrangement (332) and vertical bundle suturing principle

[0071] As shown in the arrangement (332) of FIG. 2, the bridge (110) of each staple is arranged by twisting it diagonally with respect to the direction of transport. This serves as a key mechanism that enables continuous supply of staples at regular and dense intervals in a vertical bundle suturing method. Consequently, the overall length of the magazine maintains a compact size that does not interfere with the operator's hand movements, thereby maximizing ease of operation.

[0072] 3) Expansion of Composite Diagonal Array and Gap Array

[0073] The composite diagonal arrangement (333) of FIG. 2 forms a high-density integrated structure that maximizes space efficiency in all horizontal and vertical directions by simultaneously applying diagonal arrangements of bridges (110) and legs (120).

[0074] The spacing arrangement (334) of FIG. 2 is optimized to prevent mechanical interference between legs when multiple staples are inserted simultaneously and to form a wide suture line even in a single offset magazine (621 of FIG. 4a) structure by precisely spacing multiple staples apart.

[0075] 4) Guide and support function of the central rail (311)

[0076] The central rail (311) of FIG. 2 guides the staples loaded in the various diagonal arrangements to maintain a predetermined angle and vertical orientation during transport and descent. In particular, it provides a stable staple supply by centering the staples so that they do not deviate during the process of transporting thin elastic staples diagonally.

[0078] 3. Operating mechanism (see FIG. 3a, 3b, and 3c)

[0079] (1) Leg elastic expansion system using a movable leg expansion wedge (see Fig. 3a)

[0080] This embodiment directly controls the elasticity of the leg through a movable leg extension wedge (312) placed on the downward path of the staple, and is driven in the following steps.

[0081] 1) Waiting and entry phases

[0082] When a single driver (210) presses down the staple (100), both legs (120) come into contact with the top of the movable leg extension wedge (312) positioned at the bottom of the magazine and are in a ready-to-insert state.

[0083] 2) Elastic energy accumulation stage

[0084] When the staple is lowered further by additional pressure from the driver (210), the left and right legs (120) spread outward along the inclined surface of the wedge (312) that is moved left and right. At this time, elastic restoring energy is accumulated in the entire staple structure including the elastic bridge (110), and the width of the unfolded legs expands wider than the wound area.

[0085] 3) Release of restraint and composite insertion step

[0086] The moment the staple (100) enters the skin (400), the staple passes the lower end point of the wedge (312) or the wedge itself moves backward, losing its restraining force. At the same time, the accumulated elastic restoring force ( F elastic The leg is folded inward by the (210) and firmly anchored into the tissue in combination with the vertical pressing force of the driver (210).

[0088] (2) Bridge deformation-based stepwise active / passive insertion system (see Figs. 3b and 3c)

[0089] This embodiment maximizes insertion precision through a combination of the staggered operation of a split driver and a wedge or guide, and provides two modes depending on the driving method.

[0090] a. Active control method using a movable wedge (Fig. 3b)

[0091] 1) Step 1 (Full descent and waiting): The split driver (210a, b, c) descends with the staple and waits at the position immediately before insertion.

[0092] 2) Step 2 (Bridge pressing and unfolding): The central driver (210a) protrudes first to press the center of the bridge (110), and at this time, the movable bridge deformation wedge (313) acts as a fixed point to bend the bridge downward and unfold the leg.

[0093] 3) Step 3 (Synchronized Insertion): At the moment the staple (100) enters the skin (400), the movable bridge deformation wedge (313) moves backward and the restraining force is lost, and at this time the elastic restoring energy of the bridge and the final auxiliary insertion force of the left and right split drivers (210b, 210c) F driver ) combine to complete tissue penetration.

[0094] B. Manual control method using a fixed guide (Fig. 3c)

[0095] This method utilizes the path itself through which the staple passes the fixed expansion guide (314) as a control mechanism without a separate wedge drive.

[0096] By applying a specific shape of the guide such as a protruding bump type (314a), a curved rail type (314b), or a tapered block type (314c), smooth unfolding and spontaneous restoration are induced when the staple is lowered, thereby maximizing the economy and continuity of operation of the disposable device.

[0098] 4. Bundle suturing mechanism for incisions according to operating mode (see Figs. 4a and 4b)

[0099] The suturing system according to the present invention features a dual method of operating the instrument according to the direction of the wound incision line, and both methods are based on bundle suturing technology that efficiently supplies a large amount of staples.

[0100] 1) Parallel motion bundle suture system (Fig. 4a)

[0101] The parallel operation method of FIG. 4a is a method of moving the instrument along the direction of progression of the incision and continuously supplying a bundle of staples. This instrument is based on a gap arrangement (334, see FIG. 2) to place staples along a line parallel to the incision, but may also use a combination of a bridge diagonal overlapping arrangement (332 in FIG. 2) to compactly mount a large amount of staples. Accordingly, by securing the operator's field of view through a single offset magazine (621) structure, the bundle of staples is guided to be precisely aligned along the incision line.

[0102] By combining the curved design (Curving) and gap arrangement of the magazine (621), the maximum number of staples can be compactly loaded within a limited space while maintaining the ergonomic convenience of the device.

[0103] At this time, the magazine (621) is coupled with an offset structure that is biased to one side from the instrument shaft (620) held by the surgeon. This structural feature fundamentally prevents the magazine from obstructing the surgeon's view during bundle suturing, thereby helping the surgeon proceed with the surgery while precisely checking the insertion point of the staple along the incision line in real time.

[0104] The aforementioned gap arrangement curve design magazine and diagonal overlapping array multi-row offset magazine can also be used with existing plastic deformation staples.

[0105] 2) Vertical motion type bundle insertion mechanism (Fig. 4b)

[0106] The vertical operation method of FIG. 4b is a method of positioning the instrument vertically in the incision to simultaneously secure multiple staples in a direction across the wound. A multi-row offset magazine (622) is mounted inside the vertical housing head (600), and each magazine is densely packed through a bridge diagonal overlapping array (332). This enables precise bundle suturing in which multiple staples (three in FIG. 4b) are simultaneously inserted across a wide incision with only one vertical movement, while minimizing obstruction of the surgeon's view, and enables rapid closure of large wounds such as those from open surgery.

[0108] 5. Clinical Significance

[0109] The single and multiple suture systems according to the present invention have the following clinical advantages compared to conventional suturing methods.

[0110] 1) Increased suturing efficiency

[0111] The bundle suturing system reduces suturing time to about 1 / 3 to 1 / 4 of the conventional level through a bundle insertion mechanism in wide incisions requiring repeated suturing, such as mammary tumor surgery and open surgery.

[0112] 2) Precision suturing possible

[0113] High-precision suturing required in plastic surgery, small animal surgery, and pediatric fields can be performed through a leg (120) implemented with a microneedle structure.

[0115] 6. Technical scalability of household and hybrid application embodiments (see FIG. 5)

[0116] The elastic-based deployment insertion principle according to the present invention can be extended and applied not only to specialized hospital instruments but also to various suturing systems such as the following.

[0117] 1) Self-care system

[0118] As illustrated in FIG. 5, the elastic bridge (110) and pressure support projection (510) structure of the present invention provides an environment in which a patient can insert and suture staples themselves using a dedicated clamp-type insertion and removal device (500) even in an environment without specialized instruments, and then safely remove them. This is a core technical concept that maximizes the convenience of post-operative care.

[0119] To achieve a low-pain insertion structure, an ultra-fine leg (120) with a diameter of 0.05 mm to 0.5 mm is applied, and the internal elastic compensating member is inserted through a clamp-type insertion and removal device (500) by adjusting the pressure so that it is always inserted only to a certain depth.

[0120] The self-removal mechanism is such that when the pressure support projections (510) at both ends of the bridge are pressed with a clamp-type insertion and removal device (500), the bridge is elastically deformed, releasing the resistance of the epidermal tissue, and is safely removed without pain.

[0121] 2) Combination with adhesive suture aids (530, 540)

[0122] The elastic staple (100) of the present invention can be used in combination with an adhesive band (530) or a rail-type wound closure aid (540) attached to the skin surface, allowing a general user to select it according to the size and environment of the wound without the need for specialized medical equipment. In this case, a hybrid system is formed in which the tensile force of the aid and the mechanical fixing force of the staple mutually complement each other, and this has the effect of compensating for the problem of reduced adhesion due to moisture or bodily fluids through the penetrating fixation principle of the present invention.

[0123] The adhesive auxiliary-based bonding system (hybrid mode I) is configured such that an adhesive auxiliary (530) is bonded to an elastic staple (100). First, an adhesive auxiliary (530) in the form of a standard band is attached to the wound site, and then the staple (100) is inserted through the guide hole at the top. In this way, the chemical adhesive force of the band provides primary protection to the epidermis, and the mechanical anchoring of the staple provides secondary fixation to the deep tissue. This method perfectly compensates for the disadvantage of the band falling off due to moisture or activity by using the fixing force of the staple.

[0124] The rail guide type wound closure system (hybrid mode II) is configured such that an adhesive aid (530) and a rail-type wound closure aid (540) are combined with an elastic staple (100), and a physical rail-type wound closure aid (540) is provided on the upper part of the adhesive layer, allowing the user to sequentially fasten staples along the trajectory of the rail. According to this, since the rail structure (540) forcibly guides the insertion spacing, angle, and depth of the staples, even a non-professional can perform hospital-level precise wound closure. In particular, it is optimized for physically holding joint wounds that are prone to opening up tightly.

[0125] 3) Technical comprehensiveness

[0126] The embodiments described above should be interpreted as encompassing all forms of suture systems utilizing the 'elastic recovery-based stepwise insertion mechanism' and the 'barb release principle linked to bridge deformation,' which are the essence of the present invention, regardless of external form or the presence or absence of additional auxiliary materials.

[0128] 7. Specifications, material, and shape characteristics of the elastic staple (100)

[0129] The elastic staple (100) according to the present invention can be implemented with various numerical values ​​and materials as follows, depending on the characteristics of the tissue to be applied and the purpose of the surgery.

[0130] 1) Dimensional Standards

[0131] The total width of the staple (100) can be selected within the range of about 2 mm to 60 mm.

[0132] It is preferable that the length of the elastic bridge (110) be formed in the range of about 1.5 mm to 40 mm, and the length of the left and right legs (120) be formed in the range of about 0.8 mm to 20 mm. The diameter (thickness) of the legs (120) may be formed in the range of about 0.05 mm to 3.0 mm, and in particular, for microneedle structures for plastic surgery, pediatric and small animal applications, it may have an ultrafine diameter of 0.05 mm to 0.5 mm.

[0133] 2) Material composition

[0134] As metal materials, metals with excellent elasticity and biocompatibility, such as stainless steel, nitinol, titanium alloy, and cobalt-chromium alloy, are included. As polymer materials, biodegradable polymer materials such as PLLA, PLGA, PDS, PGA, PDO, and PCL can be formed either alone or in combination with metal materials.

[0135] 3) Shape deformation (see Fig. 6)

[0136] The elastic bridge (110) is formed in a straight shape, a curved shape, an arch shape, or an S-shape and has a structure capable of storing elastic energy. The leg (120) may include at least one shape among a curved shape (120a), a hook shape (120b), a straight shape (120c), a barb shape (122a, 122b), or an anchor shape to maximize tissue fixation force.

[0137] 4) Core elastic mechanism

[0138] In particular, the present invention is characterized by the technical feature that the elastic bridge (110) is formed into a pre-elastically deformed curved or arched structure, so that after being temporarily straightened or bent by an external force such as a driver, the leg (120) recovers (contracts) in the direction of insertion into the tissue by the elastic restoring force generated when the external force is removed. Explanation of the symbols

[0139] 100: Staple 110: Bridge 120: Leg 120a: Inward-curved leg 120b: Right-angle curved leg 120c: Straight leg 122a: Single cuticle barb 122b: Multistage barb 210: Single actuator 210a, b, c: Split actuator 220: Common drive bar 312: Wedge for movable leg extension 313: Movable expansion guide wedge 314: Fixed expansion guide 314a: Bump-fixed expansion guide 314b: Curved rail fixed extension guide 314c: Tapered Block Fixed Extension Guide 332: Bridge diagonal nested array 334: Spacing arrangement or multi-row parallel arrangement 400: Suture Target 500: Forceps-type Insertion and Removal Instrument 510: Pressure support projection 520: Staple guide tip 530: Adhesive aid 540: Rail-type wound closure aid 600: Vertical housing head 620: Mechanism shaft 621: Single offset magazine 622: Multi-column offset magazine

Claims

Claim 1 A suturing system for suturing biological tissue comprises: a staple (100) comprising a bridge (110) capable of elastic deformation and elastic restoration, and a plurality of legs (120) extending from both ends of the bridge (110); and a single actuator (210) or a divided actuator (210a, 210b, 210c) for pressurizing and moving the staple (100) toward the biological tissue. and a fixed expansion guide (314) disposed on the movement path of the staple (100) and elastically deforms the staple (100) by contacting at least one of the bridge (110) and the leg (120), and accumulates elastic restoration energy in the staple (100); wherein the fixed expansion guide (314) is maintained in a fixed state within the suture system and is not inserted into biological tissue, and the staple (100), which is moved by the single actuator (210) or the split actuator (210a, 210b, 210c), is elastically deformed while passing through the fixed expansion guide (314), and then begins elastic restoration as the restraint by the fixed expansion guide (314) is released, and the elastic restoration force generated by the elastic restoration energy accumulated in the staple (100) and the single actuator (210) or the split actuator (210a, 210b, A suture system characterized by the fact that the indentation force of 210c) acts in combination so that the shape of the staple (100) changes while it is inserted into the biological tissue and penetrates the biological tissue. Claim 2 delete Claim 3 delete Claim 4 A suturing system according to claim 1, wherein the split driving members (210a, 210b, 210c) comprise: a central driver (210a) that presses the central part of the bridge (110); and left and right split drivers (210b, 210c) that are positioned corresponding to both sides of the bridge (110) or the plurality of legs (120). Claim 5 A suturing system according to claim 4, wherein the central driver (210a) moves ahead of the left and right split drivers (210b, 210c) to elastically deform the staple (100) by contacting it with the fixed expansion guide (314), and while elastic restoring energy is accumulated in the staple (100), the left and right split drivers (210b, 210c) press the staple (100) in the direction of biological tissue, and at the time when the restraint by the fixed expansion guide (314) is released, the elastic restoring force and the pressing force of the left and right split drivers (210b, 210c) act together. Claim 6 A suturing system according to claim 1, wherein the fixed expansion guide (314) includes a deformation induction section in which the amount of contact with the staple (100) increases according to the direction of movement of the staple (100), and a restoration initiation section in which the amount of contact with the staple (100) decreases or contact is released. Claim 7 delete Claim 8 delete Claim 9 delete Claim 10 delete Claim 11 delete Claim 12 delete Claim 13 delete Claim 14 delete Claim 15 delete Claim 16 delete Claim 17 delete Claim 18 delete Claim 19 delete Claim 20 A suture system according to claim 1, characterized in that the fixed expansion guide (314) is configured to increase the spacing between the plurality of legs (120) by contacting the bridge (110) and elastically deforming the bridge (110). Claim 21 A suture system according to claim 1, wherein the fixed expansion guide (314) is configured to contact at least one of the plurality of legs (120) and elastically deform the leg (120) in an outward direction. Claim 22 A suture system according to claim 1, characterized in that the fixed expansion guide (314) contacts the bridge (110) and the plurality of legs (120) respectively, so as to cause deformation of the bridge (110) and an increase in the gap between the plurality of legs (120) to occur together. Claim 23 A suturing system according to claim 1, wherein the fixed expansion guide (314) comprises a protrusion bump fixed expansion guide (314a), a curved rail fixed expansion guide (314b), a tapered block fixed expansion guide (314c), or a combination thereof, and is configured such that the amount of elastic deformation of the staple (100) gradually increases as the staple (100) moves along the fixed expansion guide (314). Claim 24 A suturing system according to claim 6, characterized in that the staple (100) is configured to penetrate or grip biological tissue while the spacing between the plurality of legs (120) increases during the deformation induction section and decreases after passing the restoration initiation section. Claim 25 A suturing system according to claim 1, wherein the fixed expansion guide (314) induces elastic deformation and elastic restoration of the staple (100) but is configured not to directly transmit an insertion force in the direction of biological tissue to the staple (100), and the insertion force of the staple (100) in the direction of biological tissue is provided by the insertion force of the single actuator (210) or the divided actuator (210a, 210b, 210c) and the elastic restoration force of the staple (100). Claim 26 A suturing system for suturing biological tissue with a plurality of staples, comprising: an instrument shaft; at least one offset magazine coupled to the instrument shaft and accommodating a plurality of staples; and one or more of a single actuator (210) or a split actuator (210a, 210b, 210c) configured to move each staple accommodated in the at least one offset magazine toward the direction of the biological tissue; wherein the at least one offset magazine is positioned at a position deflected from the central axis of the instrument shaft. Claim 27 A suture system according to claim 26, characterized in that the offset magazine consists of a single magazine. Claim 28 A suture system according to claim 27, characterized in that a plurality of staples are arranged in a spaced-apart arrangement (334) in the above-mentioned magazine. Claim 29 A suture system according to claim 26, characterized in that the offset magazine is a multi-row offset magazine comprising a plurality of magazines. Claim 30 A suturing system according to claim 29, wherein each of the plurality of magazines accommodates a plurality of staples, and the plurality of staples are arranged by a bridge diagonal overlap arrangement (332) such that the bridges (110) of adjacent staples partially overlap each other. Claim 31 A suture system according to claim 26, wherein the single drive body (210) or the split drive body (210a, 210b, 210c) is positioned to correspond to each staple accommodated in at least one offset magazine. Claim 32 A suturing system according to claim 31, characterized in that the single actuator (210) or the divided actuator (210a, 210b, 210c) is configured to move a plurality of staples simultaneously or sequentially. Claim 33 A suture system according to claim 26, characterized in that the single actuator (210) or divided actuators (210a, 210b, 210c) are provided in plurality, and each actuator is configured to correspond independently to each staple. Claim 34 A suture system according to claim 26, characterized in that the offset magazine is positioned on one side with respect to the central axis of the mechanism shaft and configured so that the central area of ​​the tip of the mechanism is open.

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