SURGICAL DEVICE

Description

1 / 30 “SURGICAL DEVICE” Field of Invention

[001] The present invention relates to a surgical device for fixing non-woven material to human or animal soft tissue. Background of the Invention

[002] Implantable nonwoven materials, particularly felt, are employed in a variety of applications. They are used, for example, in cardiac, capsular and general surgery. Traditionally, felts are connected to tissue using conventional suturing techniques. A disadvantage of using sutures for connection is that the quality of the connection between the felt and the tissue is limited by the number of stitches and, if the felt is subjected to high forces, the threads can be pulled through the tissue, resulting in so-called "cheese threading," which causes tissue damage.

[003] Surgical devices were therefore developed in which a felting needle repeatedly pushes through the felt into the tissue, so as to deposit sections of fiber from the felt material into the tissue. By moving the needle through the felting material, a strong and well-distributed connection is formed between the felt and the tissue is created.

[004] WO 2022 / 100833A1 describes a surgical device with a felting needle configured to move reciprocally. The surgical device includes a guide tube and a translation rod disposed inside the guide connected to the needle. Needle protection mechanisms are described that protect the needle from damage during reciprocating motion due to contact with a rigid structure. The needle protection mechanisms are disposed between the translation rod and the needle. Brief Description of the Invention

[005] It is an object of the present invention to provide a surgical device. In particular, it is an object of the present invention to provide a Petition 870250078729, dated 03 / 09 / 2025, pages 60 / 105 2 / 30 surgical device for fixing a non-woven material to human or animal soft tissue that does not have at least some of the disadvantages of the prior art.

[006] A surgical device is described. The surgical device is suitable for attaching a nonwoven material to human or animal soft tissue by releasing individual fiber sections from the nonwoven material and guiding them into the human or animal soft tissue. The individual fiber sections may be pushed, dragged, or otherwise brought or deposited into the human or animal soft tissue, where they remain so as to attach, connect, or anchor the nonwoven material to the soft tissue. The surgical device comprises a vehicle extending longitudinally, wherein the vehicle comprises a guide rod and a felting needle, and the felting needle is attached to a distal end of the guide rod.A felting needle is an elongated member comprising a working point at a distal end, wherein the working point preferably comprises, for example, a sharp point, a blade, a blunt or flat end, or a combination thereof. The guide rod and the felting needle are disposed at least partially in a guide bushing, and the felting needle is reciprocally movable between an extended position, in which the working point of the felting needle projects beyond an opening disposed at a distal end of the guide bushing, and a retracted position, in which the working point of the felting needle does not project beyond the opening disposed at the distal end of the guide bushing.The guide rod is coupled, at a distant end, to a drive mechanism by means of a force limiting element which, during operation, limits the force applied by the drive mechanism to the guide rod to a predetermined force limit when the working tip is moved from the retracted position to the extended position. Petition 870250078729, dated 03 / 09 / 2025, page 61 / 105 3 / 30

[007] In one embodiment, the force-limiting element is further configured not to limit the force applied by the drive mechanism to the guide rod to the predetermined force limit when the working tip is moved from the extended to the retracted position. In this way, the force transfer during the retraction of the working tip is not limited by the predetermined force limit. In particular, the drive mechanism can apply a force greater than the predetermined force limit to the guide rod when the working tip is retracted. This is beneficial for moving the working tip back to the retracted position in a situation where the working tip may have become lodged or partially stuck, particularly where the force-limiting element may have activated during the movement of the working tip from the extended to the retracted position.

[008] In one embodiment, the force limiting element is configured to have a predetermined retraction force limit, which, during operation, limits the force applied by the drive mechanism to the guide rod to a predetermined retraction force limit when the working tip is moved from the extended position to the extended position. The predetermined retraction force limit may be different from the predetermined force limit during extension, particularly where the predetermined retraction force limit may be greater than or equal to the predetermined force limit during extension.

[009] According to one embodiment, the force-limiting element comprises a deformable element that deforms when the predetermined force limit in the longitudinal direction is reached, so as to interrupt the transmission of force in the longitudinal direction. Preferably, the force-limiting element does not attenuate the force applied by the drive mechanism until the predetermined force limit is reached. Preferably, the force-limiting element is configured to return to an initial state when the force Petition 870250078729, dated 03 / 09 / 2025, page 62 / 105 4 / 30 applied for removal and / or the felting needle returns to the retracted position. Preferably, the force-limiting member does not break when the predetermined force limit is exceeded.

[0010] The deformable element is, for example, a deformation element that extends between a first end and a second end in the longitudinal direction and deforms in a lateral direction, where the lateral direction is orthogonal to the longitudinal direction, when the predetermined force limit is reached. The deformation element is configured so that it deforms when the predetermined force limit is reached. The deformation element may have a circular, rectangular, oval and / or V-shaped cross-section.

[0011] The force limiting mechanism may exhibit hysteresis. Hysteresis may be exhibited, for example, in the displacement of the working tip of the felting needle in the longitudinal direction, as a function of the displacement of the drive mechanism in the longitudinal direction, in situations where the force on the working tip in the longitudinal direction (particularly, a force directed to the dorsal end of the working tip) exceeds the predetermined force limit. In particular, the displacement of the working tip of the felting needle from a retracted position to an extended position, as a function of the displacement of the drive mechanism, may be different from the displacement from the extended position back to the retracted position.Alternatively or additionally, hysteresis can be exhibited in the force exerted on the working tip of the needle in the longitudinal direction, as a function of the displacement of the guiding mechanism in the longitudinal direction in situations where the force on the working tip in the longitudinal direction (particularly a force directed towards the dorsal end of the working tip) exceeds the predetermined force limit. Specifically, during extension, if the needle strikes a rigid object, the force exerted on the needle by the guiding mechanism... Petition 870250078729, dated 03 / 09 / 2025, page 63 / 105 5 / 30 rises rapidly until it reaches the predetermined force limit, and the force then remains constant or decreases (preferably, it is interrupted, i.e., the force drops rapidly). The drive mechanism may, for example, become substantially separated from the working tip. In the opposite direction, however, particularly when the working tip moves from an extended to a retracted position, the force-limiting mechanism may not limit the pulling force exerted on the working tip by the drive mechanism to the predetermined force limit. As a result, if the working tip becomes lodged in the rigid object (e.g., hard tissue) and the force limit is reached, the working tip can be pulled out of the rigid object under greater force, ensuring that even if the drive results in entanglement in the rigid object, the working tip can still be removed.The deformation element can be fixed at the first end and / or at the second end. In particular, the deformation element can be fixed to the guide rod at the first (distant) end and / or to the driving element at the second (dorsal) end. Alternatively, the deformation element can be pivot-fixed to the first end and / or second end.

[0012] In one example, the deformation element may be preformed, so that the deformation element deforms when the predetermined force limit is reached during operation. Preforming may include tensioning the deformation element, annealing the deformation element, and / or bending the deformation element. Preforming may include the introduction of imperfections such as notches, defects, stress concentration points, etc.

[0013] In one example, the working tip of the felting needle includes conduction means to support the conduction of individual fiber sections from the nonwoven material to the soft fabric. Petition 870250078729, dated 03 / 09 / 2025, page 64 / 105 6 / 30

[0014] In one example, the driving medium includes an essentially flat back section disposed at an end distal to the working tip. The essentially or substantially flat back section may include one or more flat and / or curved surfaces disposed substantially orthogonally to the longitudinal direction. The flat back section may, for example, have a circular, oval and / or rectangular cross-section. The flat back section may include protrusions and / or recesses designed to capture, secure and / or pull the fibers. The flat back section may have a rough surface.

[0015] Alternatively or additionally, the working tip's driving means may include protrusions and / or recesses along an outer shaft of the working tip to carry sections of individual fibers into the soft tissue. The recesses and / or protrusions may be designed in the form of indentations or recesses into the outer shaft and / or as protrusions of the outer shaft. The protrusions and / or recesses may include, for example, hook, crown, notch and / or barb elements. The working tip may have a circular cross-section, a triangular cross-section, a star-shaped cross-section, a helical cross-section and / or a screw-thread cross-section.

[0016] According to one embodiment, the surgical device comprises a frame to which the guide bushing and the drive mechanism are attached.

[0017] The frame may comprise a recess in which the force-limiting element is disposed between the dorsal end of the guide bushing and the drive mechanism. The recess may be designed to accommodate the deformation of the deformation element, particularly by having a lateral dimension with an extension greater than the extension of the deformation element.

[0018] In one realization, a channel extends in the direction Petition 870250078729, dated 03 / 09 / 2025, page 65 / 105 7 / 30 longitudinal between the guide rod and the guide bushing. The channel prevents the accumulation of pressure differences in the longitudinal direction, thus avoiding the occurrence of a pumping effect, in which reciprocating motion causes a fluid, such as air, to be pumped in a distant direction. The channel preferably extends along half the distance between the guide rod and the guide bushing.

[0019] The guide rod comprises or defines, for example, a channel that extends in the longitudinal direction. Alternatively or additionally, the guide bushing comprises or defines a channel.

[0020] The drive mechanism may comprise an adapter for connecting the drive mechanism to an external actuator. The external actuator is configured to drive the drive mechanism via the adapter when it engages with the adapter. The external actuator may be releasable and connected to the surgical device, for example, using a releasable quick-release mechanism. The external actuator may be powered by electrical power, pneumatic power, etc.

[0021] In one embodiment, the guide bushing opening is formed by a guide bushing collar having an inner diameter smaller than the inner diameter of the guide bushing. The guide bushing collar includes a transition surface at a distal end and / or at a dorsal end. The transition surface(s) is / are designed to ensure that the felting needle extends and retracts correctly into and out of the guide bushing collar, particularly that the working tip of the felting needle does not snag or become fixed to the guide bushing collar, even if lateral force is applied to the felting needle during extension or retraction. The transition surfaces may include one or more bevels, chamfers, and / or fillets, etc. Essentially, the transition surfaces are oriented away from the longitudinal direction, so that the felting needle, when incident on the transition surfaces, undergoes deflection in the longitudinal direction. Petition 870250078729, dated 03 / 09 / 2025, p. 66 / 105 8 / 30

[0022] In a preferred embodiment, the felting needle is made of metal, such as a metal alloy, for example, stainless steel or nitinol. The guide rod is made, for example, of an injection-molded plastic material that at least partially covers the felting needle opposite the working tip, to securely fix the felting needle to the guide rod. The frame may be made of an injection-molded, fiber-reinforced plastic material.

[0023] In one embodiment, the force-limiting element and the felting needle are integrally formed and extend through the guide rod.

[0024] In one embodiment, the guide rod comprises at least two opposing notches between which a portion of the force-limiting member is disposed.

[0025] In one variation, the force-limiting element is coupled to the drive mechanism by a piston rod. The drive mechanism may also include the piston rod. The piston rod may be connected to a sliding pin fixed to a rotating element driven by the external actuator.

[0026] In one variation, the force-limiting element is coupled to the drive mechanism by a Scotch yoke. The Scotch yoke includes a sliding yoke and a connecting rod, wherein the connecting rod is fixed to the force-limiting element. The Scotch yoke additionally includes a sliding pin fixed to the rotating element driven by the external actuator.

[0027] The rotating element can be a crank, wheel or disc, for example.

[0028] The frame may include a cylinder arranged in the longitudinal direction. The drive mechanism may include a piston (or rod of Petition 870250078729, dated 03 / 09 / 2025, page 67 / 105 9 / 30 connection) disposed at least partially inside the cylinder. The piston is connected at one distal end to the force-limiting element and at one dorsal end to the piston rod. The cylinder is configured to guide the piston or connecting rod by means of reciprocating motion when the surgical device is in operation.

[0029] The frame may be at least partially concealed by an outer enclosure. The enclosure may comprise two enclosure halves made of injection-molded plastic material.

[0030] The guide rod may comprise at least two guide surfaces separated from each other in the longitudinal direction. The guide surfaces are preferably designed to provide a low-friction interface between the guide rod and the guide bushing.

[0031] It should be understood that both the general description above and the detailed description below present embodiments of the present invention and are intended to provide an overview or framework for understanding the nature and character of the present invention. The accompanying figures are included to provide further understanding, are incorporated into, and form part of, this descriptive report. The figures illustrate various embodiments and, together with the descriptive report, serve to explain the principles and operation of the concepts described. Brief Description of the Figures

[0032] The present invention will be more fully understood from the detailed description provided below and the accompanying figures, which should not be considered limitations of the present invention described in the appended claims. The figures show: Figure 1 schematically shows a side view of a surgical device; Figure 2 schematically shows a view in Petition 870250078729, dated 03 / 09 / 2025, page 68 / 105 10 / 30 exploded view of a surgical device; Figure 3 schematically shows a perspective view of a vehicle; Figure 4 schematically shows a perspective view of a vehicle section that includes a distant end of a guide rod and a felting needle; Figure 5 schematically shows a perspective view of a working tip of a felting needle; Figure 6 schematically shows a perspective view, including interior lines, of a vehicle section that includes a dorsal end of a guide rod and part of a force-limiting element; Figure 7 schematically shows a cross-sectional perspective view of a surgical device; Figure 8 schematically shows a cutaway perspective view of a far end of a guide bushing and additionally shows a far end of a vehicle that includes part of a guide rod and a felting needle in the retracted position; Figure 9 schematically shows a cutaway perspective view of part of a surgical device, which includes in particular a force-limiting element and a drive mechanism; Figure 10 schematically shows three plan views of a surgical device, in which the felting needle is in a retracted position, in an extended position, and the felting needle is partially extended and in contact with a surface, so that the force-limiting element is fitted; and Figure 11 shows two graphs that illustrate the displacement. Petition 870250078729, dated 03 / 09 / 2025, page 69 / 105 11 / 30 of the needle and the force exerted on the needle tip as a function of the displacement of the drive mechanism. Detailed Description of the Invention

[0033] Detailed reference will now be made to specific embodiments, examples of which are illustrated in the accompanying figures, which show some, but not all, of their features. In fact, the embodiments described herein can be incorporated in many different forms and should not be interpreted as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present invention satisfies applicable legal requirements. Whenever possible, similar reference numerals will be used to indicate similar parts or components.

[0034] Figure 1 shows a side view of a surgical device schematic 1. Surgical device 1 is a portable device that is normally operated by a surgeon. Surgical device 1 is used to connect a non-woven material, such as felt material, to soft tissue in a human or animal body. Surgical device 1 is a sterilized device that is normally manufactured and assembled in a cleanroom environment. Surgical device 1 is normally sterilized after assembly and stored in a sterile package for use in surgery. After use, surgical device 1 must be cleaned and sterilized or discarded.

[0035] For sterilization, for example, during or after manufacture, or after use, it is important that the distal end of the surgical device 1, particularly any part that penetrates or comes into contact with a human or animal, be easily accessible by sterilizing fluids. In particular, the sterilizing fluid must be able to circulate freely along all the external and internal surfaces of the surgical device 1.

[0036] Surgical device 1 has an outer sheath 28 made of Petition 870250078729, dated 03 / 09 / 2025, pp. 70 / 105 12 / 30 plastic material formed by injection molding. The outer housing 28 defines a gripping area in which the surgical device 1 can be retained by the surgeon. The outer housing 28 further defines an upper part, which is elongated in the longitudinal direction, wherein the upper part includes an opening designed to receive a guide bushing 28. The outer housing 28 is formed from two parts, which are fixed together along a joining line. The joining line extends around the outer housing 28 substantially in a lateral plane (yz). In this way, the risk of pinching the surgical gloves at the joining line during the operation is reduced. The two parts are joined using, for example, a press-fit connection, linkage and / or additional retention mechanisms, including a quick-release mechanism, screws, etc.

[0037] The guide bushing 8 is fixed to the outer housing 28, particularly to the opening of the outer housing 28, at a dorsal end 28 of the guide bushing 8. The guide bushing 8 has an elongated shape, such as a hollow cylindrical shape, for example, a hollow circular cylindrical shape, with a diameter of 2 mm to 10 mm, preferably 3 mm to 8 mm and, more preferably, 5 mm. The guide bushing 8 has a longitudinal extension of 2 cm to 30 cm, preferably 5 to 20 cm and, more preferably, 15 cm. The guide bushing 8 has a distal end 19, which includes an opening 11. The distal end 19 may be chamfered and / or threaded. The guide bushing 28, at the dorsal end, is open to the inside of the outer housing 28.

[0038] The guide bushing 8 at least partially covers a vehicle 4 (not shown), wherein the vehicle 4 comprises a guide rod 5 and a felting needle 6. The guide rod 5 has a cross-sectional shape that is at least partially complementary to an interior cross-section of the guide rod 5, such that the guide rod 5 can move reciprocally (i.e., back and forth) inside the guide bushing 8 in a longitudinal direction without Petition 870250078729, dated 03 / 09 / 2025, p. 71 / 105 13 / 30 Excessive lateral movement. Vehicle 4 is explained in more detail below with reference to Figures 2 to 4.

[0039] In one embodiment, the guide bushing 8 may be flexible along at least part of its length. The guide bushing 8 may be implemented in catheter form. The guide bushing 8 may be flexible along its entire length. The guide bushing 8 may be bent into a specific shape and retain that shape after bending. The guide bushing 8 may therefore be shaped into a specific shape for a specific surgery, for example, to optimally reach a surgical site. By flexible, as mentioned herein, it may be understood that the guide bushing 8 may be bent, particularly during navigation along a curved path of a hollow organ (e.g., a blood vessel) and / or is capable of being placed in a bent shape. Preferably, the guide bushing 8 is flexible along its entire length. Alternatively, the guide bushing 8 may have one or more flexible sections.

[0040] A working tip 7 of the felting needle 6 is shown extending outward (i.e., beyond) the opening 11 in the extended position. In the retracted position, the working tip 7 of the felting needle 6 is retracted into the opening 11.

[0041] An external actuator 25 is releasably connected to the surgical device 1 and drives the drive mechanism (not shown). The external actuator 25 can be connected using a quick-release connector, such as a suspended quick-release connector. Part of the suspended arm extends through the external housing 28, which, when pressed, causes the quick-release connection to disengage and release the external actuator 25. When the external actuator 25 is switched on, the working tip 7 of the felting needle 6 moves back and forth in a reciprocating motion between the retracted and extended positions. Preferably, the frequency Petition 870250078729, dated 03 / 09 / 2025, page 72 / 105 14 / 30 of the reciprocating motion is 1-200 Hz, preferably 10-100 Hz, more preferably 20-80 Hz and, in one specific example, 40 Hz. When the external actuator 25 is switched off, the working tip 7 returns to the retracted position, as explained in more detail below, with reference to Figure 2.

[0042] Figure 2 shows the internal side of the surgical device 1. A frame 21 is disposed inside the outer housing 28. The frame 21 has, at a distal end in the x-longitudinal direction, an opening to receive a dorsal end of the vehicle 4, particularly the guide rod 5. The frame 21 has, next to the opening, a recess 22 within which the force-limiting element 16 is disposed. The recess 22 is designed so that the force-limiting element 16, particularly a deformation element 16, has sufficient space to deform in the lateral xy direction. The deformation element 16 is preferably configured to deform in the lateral xy direction when a predefined force limit is reached. The force-limiting element 16 is connected to the vehicle 4, particularly to the guide rod 5. The force-limiting element 16, for example, is attached to a dorsal end of the guide rod 5.

[0043] The force-limiting element 16 is connected, at a dorsal end 17, to a drive mechanism 14. The drive mechanism 14 is connected, during operation, to the external actuator 25. The drive mechanism 14 may include an adapter 24 configured to fit onto a rotating end of the external actuator 25. The drive mechanism 14, particularly the adapter 24, is configured to translate the rotary motion of the external actuator into a reciprocating motion for driving the vehicle 4 in reciprocating motion. The drive mechanism 14 may include a piston rod, a Scotch yoke 27, or other suitable mechanism that performs the translation of the rotary motion. Specifically, the external actuator 25 is configured to rotate in the x y plane. The adapter 24 Petition 870250078729, dated 03 / 09 / 2025, page 73 / 105 15 / 30 fits with external actuator 25.

[0044] Adapter 24 may include a sliding pin that rotates in a horizontal xy plane. The sliding pin may be arranged on a crank, wheel or disc, for example, of adapter 24. Specifically, the sliding pin rotates, in a horizontal xy plane, around an axis of rotation that extends in the z direction.

[0045] In one example, the force-limiting element 16 is connected directly to the sliding pin. The force-limiting element 16 may comprise, for example, a ring part mounted on the sliding pin, such that the force-limiting element 16 is driven directly by the circular motion of the sliding pin and the force-limiting element 16 also acts, therefore, as a piston rod.

[0046] Alternatively, the sliding pin fits into a piston rod or a yoke of a Scotch yoke connector.

[0047] Adapter 24 is configured so that the rotation diameter of the sliding pin is 5-40 mm, preferably 10-30 mm, and most preferably 15-20 mm. The rotation diameter defines a range of movement of the vehicle 4. Specifically, the rotation diameter defines a range of movement of the working tip 7 of the needle between a retracted and an extended position. The maximum extension of the working tip of the needle 7 beyond the opening 11 is defined by the rotation diameter and a distance between the opening 11 and the working tip 7 when the working tip 7 is in a retracted position. Preferably, the surgical device 1, particularly the rotation diameter and the distance between the opening 11 and the retracted working tip 7, is designed so that the maximum extension of the working tip 7 is 1-30 mm, preferably 6-15 mm. Specific examples of the maximum extension are 6.5 mm, 8.5 mm, or 12 mm.

[0048] The work tip 7 includes a configured driving medium. Petition 870250078729, dated 03 / 09 / 2025, pp. 74 / 105 16 / 30 to carry (e.g., transport by pushing, pulling or dragging) sections, i.e., lengths of fibers of the nonwoven material into the soft tissue, as the working tip 7 moves through the nonwoven material into the soft tissue.

[0049] The conducting medium may be disposed over a distal end of the working tip 7. The conducting medium thus conveniently enables the working tip 7 to deposit fiber lengths at the maximum penetration depth of the working tip 7. Conducting media disposed over the distal end of the working tip 7 include, for example, a flat posterior section 41 of the working tip 7.

[0050] Alternatively or additionally, the driving means may be arranged on an outer rod 40 of the working tip.

[0051] The drive mechanism 24 includes a guiding member 31, such as a helical spring, configured to return the vehicle 4 to a retracted position when the external drive is switched off. Specifically, the guiding force of the guiding member 31 is configured to exceed a breaking force of the external drive 25. The guiding member 31 is connected at one end to the frame 21, particularly a lateral inner wall of the frame 21, and at the other end to the adapter 24. The lateral inner wall is arranged in the yz plane and divides the frame 21 into a distal section, which substantially encompasses the force-limiting element 16, and a dorsal section, in which the drive mechanism 14 is substantially disposed. The guiding member may be arranged around a dorsal end of the force-limiting element 16 to achieve a compact design.

[0052] The frame 21 additionally includes a hole 32 oriented in the longitudinal x direction, wherein the hole 32 is configured to restrict the movement of the drive mechanism 14 and / or the limiting element of Petition 870250078729, dated 03 / 09 / 2025, p. 75 / 105 17 / 30 force 16 in the longitudinal direction. More specifically, a piston or connecting rod of the drive mechanism 14 and / or the force limiting element 16 is disposed in the hole 32. The hole 32 is preferably disposed next to the inner wall of the frame 21.

[0053] Figure 3 schematically shows a perspective view of a vehicle 4. The vehicle 4 comprises a felting needle 6 and a guide rod 5. The felting needle 6 is disposed at a distal end (in the positive longitudinal x direction) of the vehicle 4 and is connected to the guide rod 5. The vehicle 4 is connected at a dorsal end to a force-limiting element 16. The guide rod 5 has a cylindrical shape, such as a circular, oval or rectangular cylindrical shape with a cross-sectional extension (e.g., diameter) of 2 mm to 8 mm, preferably 5 mm. The guide rod 5 is preferably made of injection-molded plastic material. The guide rod 5 may have edge fillets.

[0054] Vehicle 4 is manufactured, for example, by arranging a dorsal section of the felting needle 6 and a distant section of the force-limiting element 16 in a mold and then by injecting molding plastic material to form the guide rod 5.

[0055] In one embodiment, the felting needle 6 and the force-limiting element 16 are integrally formed, i.e., they are made of one continuous piece, and the guide rod 5 is formed by means of injection molding plastic material around the felting needle 6 and the force-limiting element 16.

[0056] The guide rod 5 may include one or more channels 23 on an outer surface, wherein these channels 23 extend at least along part of the outer surface of the guide rod 5. The channel(s) 23 serve(s) to prevent the buildup of pressure inside the guide bushing 8 due to the reciprocating motion of the vehicle 4 when the surgical device 1 is in operation. Petition 870250078729, dated 03 / 09 / 2025, page 76 / 105 18 / 30

[0057] The channel(s) 23 may additionally fit with guiding means on an inner surface of the guide bushing 8, wherein this guiding means has a shape complementary to the guide bushing 8 and serves to guide the guide rod 5 inside the guide bushing 8 in a predetermined orientation (i.e., at a predetermined angle in the yz plane). In other words, the channel(s) 23 may fit with the guiding means to prevent rotation of the guide rod 8 around the longitudinal x-axis.

[0058] The guide rod 5 may additionally include one or more orientation surfaces 30 configured for sliding engagement with the guide bushing 8. The orientation surfaces 30 may be formed from a material different from the rest of the guide rod 5. The orientation surfaces 30 may be formed, for example, from a material that reduces friction between the guide rod 5 and the guide bushing 8, such as PTFE. The orientation surfaces 30 may have a lateral cross-section that is at least partially complementary to an inner lateral cross-section of the guide bushing 8. The orientation surfaces 30 have a defined longitudinal extension, for example, a longitudinal extension of about 10 mm. The orientation surfaces 30 are preferably disposed at or near a distal end of the guide rod 5 and at or near a dorsal end of the guide rod 5, i.e., up to 3 cm from the dorsal and / or distal end of the guide rod.

[0059] The guide surfaces 30 preferably do not surround an entire section of the guide rod 8, preferably providing at least a gap to allow air to pass beyond the guide surfaces 30, in order to avoid any pressure build-up.

[0060] In one embodiment, the guide rod 5 is flexible along at least part of its length. The guide rod 5 may be flexible along its entire length. The guide rod 5 may also be flexible only in specific sections. The guide rod 5 may be implemented in the form of an element. Petition 870250078729, dated 03 / 09 / 2025, page 77 / 105 A flexible 19 / 30 driving element is configured to transmit the driving force from the driving mechanism 14 to the felting needle 6. The flexible driving element can be implemented in the form of a driving wire, for example, connected at a distal end to the felting needle 6 and at a proximal end to the force-limiting element 16. Optionally, guiding elements are arranged along the driving element in the longitudinal direction to reduce friction between the driving element and the guide bushing 8. The guiding elements can eliminate contact between the driving element and the guide bushing 8. The guiding elements can be implemented in the form of concentric leading elements, which are circular, ring-shaped, and extend from an inner side of the catheter. The guiding elements also preferably have a low friction index to allow for ideal guidance and force transmission.The guide elements reduce bending forces and ultimately reduce vibrations during application. The guide elements center the guide wire in the guide bushing 8, so as to prevent bending or deformation of the guide wire in the guide bushing 8 beyond the bend of the guide bushing 8. The guide elements are preferably covered by a PTFE coating to reduce friction between the guide wire and the guide elements.

[0061] The force-limiting element 16 has a distal end 18 and a dorsal end 17. The distal end 18 is connected to the guide rod 5 and the dorsal end 17 is connected to the drive mechanism 24. Optionally, the dorsal end 17 is connected to the drive mechanism 24 by means of a piston 27. The force-limiting element 16 can be attached at the distal end 18 to the guide rod 5 and / or can be attached at the dorsal end to the piston 27.

[0062] The force-limiting element 16 may include a deformable element. The deformable element may be deformable by means of Petition 870250078729, dated 03 / 09 / 2025, p. 78 / 105 20 / 30 bending and / or deformation. The deformable element can be implemented as a deformation element 16, more particularly a deformation wire. The deformation element 16 is elongated in the longitudinal direction x and is configured to deform when the force exerted by the drive mechanism 24 on the vehicle 4 (or vice versa) in the longitudinal direction x exceeds a predetermined force limit. When the force exerted exceeds the predetermined force limit, the deformation element 16 deforms (i.e., undergoes sudden lateral deflection in the yz direction), resulting in a sudden interruption of the force exerted on the vehicle 4. The deformation element 16 can have a circular, oval, rectangular, and / or substantially linear cross-section. The deformation element 16 can be pre-formed.

[0063] The deformation element 16 is configured to return to its original shape (i.e., linear shape) when the force no longer exceeds the predetermined force limit and / or the working tip 7 has returned to a retracted position. Preferably, the deformation element 16 can deform several times without being damaged, breaking, or becoming inoperable in any way. This allows for the continuous operation of the surgical device 1, even after exceeding the predetermined force limit.

[0064] The deformation element 16 is additionally configured to transmit the translational force exerted by the drive mechanism without substantial attenuation (i.e., without elastic deformation or damping) before reaching the predetermined force limit. This ensures direct force transmission during normal operation.

[0065] The deformation element 16 is preferably configured to deform in the y direction. For this, the deformation element 16 may have a cross-sectional shape with a greater extent in the z direction than in the y direction, such as an elongated rectangular cross-sectional shape in the z direction, for example. Petition 870250078729, dated 03 / 09 / 2025, pp. 79 / 105 21 / 30

[0066] The deformation element 16 is preferably a metal, such as nitinol (nickel-titanium alloy).

[0067] The predetermined force limit may be due to the type of material, the shape (i.e., cross-section and longitudinal extension), the method of fastening and / or any processing or operation of the force-limiting element 16 (particularly, the deformation element). The processing or operation may include bending, pre-forming, pre-stressing, annealing, etc.

[0068] The force limiting element 16 is configured so that the predetermined force limit is in the range of 1 N to 20 N, preferably 2 N to 10 N, more preferably 4 N to 8 N and, preferably higher, 5 N.

[0069] The predetermined force limit ensures that the working tip 7 is not damaged during operation by inadvertent collision with hard tissue, such as bone, or another surgical instrument present at a surgical site, such as a scalpel. This ensures that damage to hard tissue is avoided and also that the working tip 7 of the felting needle 6 does not break, possibly resulting in the working tip 7 or one of its parts becoming lodged in the soft tissue of a human or animal.

[0070] Figure 4 is a close-up view of section A1 of Figure 3 and shows a far end of the vehicle 4. In particular, the felting needle 6 attached to the far end of the guide rod 5 is visible, along with channel 23 of the guide rod 5. The guide rod 5 has a substantially rectangular lateral cross-section with edge fillets. Orientation surfaces 30 are shown near the far end of the guide rod 5, wherein these orientation surfaces 30, however, do not completely cover the guide rod 5, leaving a gap that allows air movement in a longitudinal direction during the operation of the surgical device 1. A channel 23 is shown. Petition 870250078729, dated 03 / 09 / 2025, pages 80 / 105 22 / 30 in the form of an elongated recess on the surface of the guide rod, wherein the channel 23 terminates at a distal end, near the distal end of the guide rod 5. The distal end of the channel 23 is located in a section of the guide rod 5 in which the orientation surfaces 30 are arranged.

[0071] The felting needle 6 has a length of 5-50 mm, preferably 10-40 mm and, more preferably, 15-30 mm, and terminates at a distant end at the working point 7 described in more detail in reference to Figure 5.

[0072] The felting needle 6 may have a circular, oval, rectangular and / or other cross-section. In addition, the felting needle 6 may include a helical screw.

[0073] The felting needle 6 may include, on an outer surface, protrusions and / or recesses for felting, particularly designed to carry fiber sections to the soft tissue during operation. These protrusions and / or recesses may be in the form of barbs or hooks. If the felting needle 6 has a rectangular cross-section or helical screw shape, protrusions and / or recesses may be arranged on the edges of the felting needle 6.

[0074] Figure 5 is a close-up view of section A2 of Figure 4, which shows a working tip 7 of the felting needle 6. The working tip 7 shown has a shape similar to a flat-headed screwdriver and is shown only as an example. Other working tips 7 are possible, including plus-sign shaped tips, star-shaped tips, etc. The working tip 7 shown has an essentially flat back section 41. The flat back section 41 is joined to an outer surface 40 of the working tip 7 by means of lateral chamfered transition surfaces 42, 43.

[0075] The flat back section 41 may have a rough surface configured to capture fibers. The flat back section 41 may have Petition 870250078729, dated 03 / 09 / 2025, page 81 / 105 23 / 30 protrusions and / or recesses configured to capture fibers. The protrusions and / or recesses may have a width of 0.005-0.1 mm. The protrusions and / or recesses may have a depth of 0.005-0.1 mm. The protrusions and / or recesses may have a tapered shape and, in particular, may be semicircular, V-shaped or U-shaped.

[0076] In a preferred embodiment, the flat rear section 41 at the far end has a first width perpendicular to the longitudinal direction of the felting needle 6 of at most 1 mm. In a preferred embodiment, the first width is at most 0.5 mm. In a particular preference, the first width is up to 0.4 mm. Most preferably, the first width is at most 0.3 mm. These dimensions are particularly suitable for capturing fibers from the nonwoven material and loading the fibers into the soft fabric. As mentioned above, these fibers then become intertwined with the soft fabric. If the far end of the felting needle is too large, too many fibers will be captured at once and pushed towards the soft fabric. Instead of capturing a few fibers or just a single fiber that can be removed in isolation from the felt, this simply results in an excessive amount of fibers being pushed and damaging the soft fabric.

[0077] In another embodiment, the first width is at least 0.02, 0.03, 0.04, or 0.05 mm. These minimum widths ensure that the fibers can be captured by the flat back section 41. If the first width is smaller, the felting needle 6 may penetrate the felt without capturing any or only a few fibers, resulting in poor or absent fixation. Furthermore, if the first width is below these values, the felting needle 6 may cut the fibers in some cases.

[0078] The flat rear section 41 may also have a second width that is perpendicular to the longitudinal axis of the felting needle 6 and perpendicular to the first width. The second width may be at least Petition 870250078729, dated 03 / 09 / 2025, page 82 / 105 24 / 30 0.01, 0.02, 0.03, 0.04, or 0.05 mm. Similar considerations apply as for the first width.

[0079] Surface roughness can be expressed using mean line roughness of 3.2, 2.5, 2.0, 1.5, 1.0 pm or more. Mean line can be understood as the variation of a surface relative to a mean height. Roughness can be the arithmetic mean value of a roughness profile determined from variations about the centerline, within the evaluation length. The far-end roughness and, particularly, the flat back section roughness 41 can support the capture and loading of individual fibers.

[0080] Figure 6 is a close-up view of section B of Figure 3 and shows a dorsal end of the vehicle 4, particularly a dorsal end of the guide rod 5. A channel 23 on the outer surface of the guide rod 5 extends to the end of the guide rod 5. Guiding surfaces 30 are arranged on the outside of the guide rod 5, near the dorsal end of the guide rod 5. The guide rod 5 is connected to a distal end of the force-limiting element 16, wherein this force-limiting element 16 extends partially into the interior of the guide rod 5, for secure mechanical connection.

[0081] In addition, two pairs of notches 29 are shown on the guide rod 5. The notches 29 are located on a part of the guide rod 5 to which the force-limiting element 16 extends. The notches 29 extend from an outer surface of the guide rod 5 to the force-limiting element 16. For each pair of notches 29, a first notch 29 extends from an opposite surface of the guide rod 5 relative to the second notch 29.

[0082] Figure 7 shows a perspective cross-sectional view of surgical device 1. Sections C and D are described in more detail with reference to Figures 8 and 9, respectively.

[0083] Figure 8 shows a distant end of guide bushing 8 Petition 870250078729, dated 03 / 09 / 2025, p. 83 / 105 25 / 30 in which the guide rod 5 and the felting needle 6 are arranged in a retracted position. The guide bushing 8 has a cylindrical shape and covers the guide rod 5.

[0084] The guide rod 5, particularly the guide sections 30, are slidingly fitted with the inner surface of the guide bushing 8, which allows the reciprocating movement of the felting needle 6 in the longitudinal x direction. The gap between the two guide sections 30 allows air to pass beyond the guide rod 5. The channel 23, which terminates in an area of ​​the guide sections 30, additionally allows air movement inside the guide rod 5.

[0085] The gaps mentioned above between guide sections 30 and channel 23 also allow for good sterilization, as they allow the sterilization fluid to flow easily through the inside of guide bushing 8.

[0086] The guide bushing 8 includes, at a distal end, a guide bushing collar 26, which may be a separate part or be integrally formed with the guide bushing 8. The guide bushing collar 26 defines an opening 11 through which the felting needle 6 moves when the surgical device 1 is in operation. The guide bushing collar 26 is designed to guide the felting needle 6 in the longitudinal direction during reciprocating motion. The guide bushing collar 26 defines a cylinder that extends in the longitudinal direction through which the felting needle 6 moves. The cylinder terminates at a distal end in the opening 11 and has a diameter larger than the diameter of the felting needle 6.

[0087] The collar of the guide bushing 26 has, next to the cylinder, a chamfered transition surface, which is designed to guide the felting needle 6 through the cylinder and out of the opening 11 when the felting needle 6 moves from the retracted position to the extended position.

[0088] The collar of the guide bushing 26 has a curved outer surface at one far end.

[0089] Figure 9 shows section D of Figure 7 in more detail, Petition 870250078729, dated 03 / 09 / 2025, page 84 / 105 26 / 30 particularly exhibiting the frame 21, a dorsal end of the guide rod 5 of the vehicle 4 and the drive mechanism 14. As exhibited, the drive mechanism 14 includes an adapter 24 configured for fitting onto the external drive 25 (not shown). The external drive provides rotational motion in the xy plane. An upper part of the adapter 24, which is disposed in a dorsal section of the frame 21, includes a sliding pin mounted on a rotating wheel (naturally, a crank or rotating disc would also be provided). The sliding pin is connected to a Scotch yoke which performs the translation of the rotational motion into a reciprocating motion of the piston 27, wherein the piston 27 is connected to the force-limiting element 16. Alternatively, instead of a Scotch yoke, a piston rod may also be connected to the sliding pin and rotatably coupled to the piston 27.It will also be possible to make a direct connection between the force-limiting element 16 and the sliding pin, such as by enclosing the force-limiting element 16, at one dorsal end, in a loop or ring that fits into the sliding pin.

[0090] The recess 22, which is located in the section distant from the frame 21, provides space for the force-limiting member 16, as well as the deformation element 16, to deform in the y direction when the force exceeds the predetermined force limit.

[0091] The dorsal and distal sections of the frame 21 are separated by a hole 32 arranged in the longitudinal direction, which is configured to receive, at least partially, the piston 27 and / or the force-limiting element 16. The hole 32 orients the piston 27 and / or the force-limiting element 16 in the longitudinal direction.

[0092] Figure 10 shows a top-down cross-sectional view of surgical device 1 in three different states.

[0093] In Figure 10a, the vehicle 4 of the surgical device 1 is in the retracted position 10, in which the working tip 7 of the needle Petition 870250078729, dated 03 / 09 / 2025, pages 85 / 105 27 / 30 felting 6 does not extend beyond opening 11. This is a standard state of the surgical device 1 when not in operation. A guiding member (not shown) ensures that, even when the external drive is connected, a guiding force from the guiding member will return the vehicle 4 to the retracted position 10 when the external drive is switched off. The vehicle's guide rod 5 partially enters recess 22 in the retracted position 10, and the piston 27 extends almost completely out of orifice 32 towards the dorsal end of the surgical device 1. The sliding pin of the drive mechanism 14 is in its most dorsal position.

[0094] In Figure 10b, the vehicle 4 of the surgical device 1 is in the extended position 9. The working tip 7 of the felting needle 6 extends beyond the opening 11. In the extended position 9, the piston 27 enters almost completely into the orifice 32.

[0095] Figure 10c shows a state in which the working tip 7 of the felting needle 6 strikes a rigid object, causing the force exerted on the working tip 7 of the needle to exceed the predetermined force limit. The force-limiting element 16 deforms and, in particular, undergoes deflection in the y direction, so as to cause an intermediate interruption of the force transmission between the drive mechanism 14 and the felting needle 6. In this way, damage to the felting needle 6 (particularly the working tip 7) and / or the rigid object is avoided. When the force no longer exceeds the predetermined force limit, for example, because the rigid object has been removed or the felting needle 6 has been retracted, the deformation element 16 “returns to normal”, that is, returns to its initial state. The deformation element 16 can then deform again.

[0096] A Figura 11 exibe, no gráfico superior, o deslocamento da agulha de feltragem, particularmente da ponta de trabalho 7 da agulha de feltragem 6, em função do deslocamento longitudinal do mecanismo de Petition 870250078729, dated 03 / 09 / 2025, page 86 / 105 28 / 30 driving. At point 1, the working tip 7 is fully retracted. The path between points 1 and 2 indicates the working tip 7 being extended. At point 2, the working tip 7 comes into contact with a rigid object, which it cannot penetrate, and therefore the extension of the working tip 7 is interrupted. In the path between points 2 and 3, the working tip 7 does not extend further, even though the driving mechanism 14 continues to extend in the longitudinal direction. This occurs because the force exerted by the driving mechanism 14 on the working tip exceeds the predetermined force limit and, consequently, the force-limiting element 15 engages. At point 3, the driving mechanism 14 has reached its maximum longitudinal extension. At point 4, the driving mechanism 15 begins its return path. Between points 4 and 5, the driving mechanism 15 retracts, but the working tip 7 remains stationary.At point 5, the working tip 7 loses contact with the rigid object and follows the displacement of the drive mechanism 14 back to the endpoint 6. The forward and return paths do not necessarily overlap due to hysteresis, for example, in the force-limiting element 15.

[0097] In the lower diagram, the force on the working tip 7 of the needle 6 is illustrated as the needle follows the path shown in the upper diagram. Between points 1 and 2, the working tip 7 moves through soft tissue, as shown by the irregular force exerted on the working tip. At point 2, the working tip 7 encounters a rigid object, such as rigid tissue (e.g., bone) or another surgical instrument (e.g., scalpel). The force exerted on the working tip 7 reaches the predetermined force limit, and the force-limiting element 15 is activated to prevent the working tip 7 from exerting a force greater than the predetermined force limit on the rigid object. Further displacement by the drive mechanism 14 from point 2 to 3 results in a sharp reduction in the force exerted by the needle. Petition 870250078729, dated 03 / 09 / 2025, page 87 / 105 29 / 30 working tip 7 on the rigid object, as shown in the force curve trajectory between points 2 and 3. The force may suddenly drop to a minimum force level, where this minimum force level may be close to zero. On the return path, i.e., from point 4 to 5, the force exerted on working tip 7 may follow a different path than the forward path (i.e., the path from point 1 to point 3) due to hysteresis. The force on working tip 7 may, for example, become negative (i.e., be directed in a dorsal direction), at least for part of the return path. In particular, the force may become negative between points 5 and 6, during which working tip 7, which may have become partially incorporated into the rigid object, is pulled from the rigid object and then pulled back out through the soft tissue.Specifically, the force-limiting element 16 may not be activated on the return path, so that the magnitude of the force on the path between points 4 and 6 may exceed the predetermined force limit. In this way, even if the working tip 7 becomes embedded or lodged, it can be removed by the drive mechanism 14. List of designations Surgical device; Vehicle; Guide rod (vehicle); Felting needle (vehicle); Working point (needle); Guide bushing; Extended position; Retracted position; Opening (guide bushing); Far end (guide rod); Dorsal end (guide rod); Petition 870250078729, dated 03 / 09 / 2025, pages 88 / 105 30 / 30 Driving mechanism; Force limiting element; Deformation element / Deformation bar; First end (deformation element); Second end (deformation element); Far end (guide bushing); Dorsal end (guide bushing); Surgical frame (device). Petition 870250078729, dated 03 / 09 / 2025, pages 89 / 105

Claims

1 / 4 Claims 1. SURGICAL DEVICE for fixing a nonwoven material to human or animal soft tissue by releasing individual fiber sections of the nonwoven material and loading them into the human or animal soft tissue, characterized in that the device comprises: a. a longitudinally extending vehicle comprising a guide rod and a felting needle fixed to a distal end of the guide rod, wherein b. the guide rod and the felting needle are disposed at least partially in a guide bushing and the felting needle is reciprocally movable between: i. an extended position, in which the working tip of the felting needle projects beyond an opening disposed at a distal end of the guide bushing; and ii. a retracted position, in which the working tip of the felting needle does not project beyond the opening disposed at the distal end of the guide bushing; wherein c.The guide rod comprises a dorsal end, which is coupled to a drive mechanism by means of a force limiting element that, during operation, limits the force applied by the drive mechanism to the guide rod to a predetermined force limit when the working tip is moved from the retracted position to the extended position.

2. SURGICAL DEVICE according to claim 1, characterized in that the force limiting element is additionally configured so as not to limit the force applied by the drive mechanism to the guide rod to the predetermined force limit when the working tip is moved from the extended position to the retracted position.

3. SURGICAL DEVICE according to claim Petition 870250078729, dated 03 / 09 / 2025, page 102 / 105 2 / 4 1, characterized by the force limiting element comprising a deformable element, which deforms when the predetermined force limit is reached in the longitudinal direction, so as to interrupt the transmission of force in the longitudinal direction.

4. SURGICAL DEVICE according to claim 3, characterized in that the deformable element is a deformation element that extends between a first end and a second end and deforms in the lateral direction upon reaching the predetermined force limit.

5. SURGICAL DEVICE according to claim 4, characterized in that the deformation element is attached at the first end and / or at the second end.

6. SURGICAL DEVICE according to claim 3, characterized in that the deformation element is pre-formed so that the deformation element deforms when the predetermined force limit is reached during the operation.

7. SURGICAL DEVICE according to claim 1, characterized in that the working tip of the felting needle includes a conductive medium to support the loading of individual fiber sections into the soft tissue.

8. SURGICAL DEVICE according to claim 7, characterized in that the driving means includes an essentially flat posterior section disposed at the distal end of the working tip and / or barbs along an outer shaft of the working tip.

9. SURGICAL DEVICE according to claim 1, characterized in that the surgical device comprises a frame to which the guide bushing and the drive mechanism are attached.

10. SURGICAL DEVICE according to claim 9, characterized in that the frame comprises a recess, in which the force-limiting element is disposed between the dorsal end of the guide bushing and the drive mechanism.

11. SURGICAL DEVICE according to claim 1, characterized by a channel extending in the longitudinal direction between the guide rod and the guide bushing.

12. SURGICAL DEVICE according to claim 11, characterized in that the guide rod comprises a channel extending in the longitudinal direction.

13. SURGICAL DEVICE according to claim 1, characterized in that the drive mechanism comprises an adapter for connecting the drive mechanism to an external actuator.

14. SURGICAL DEVICE according to claim 1, characterized in that the opening is formed by the collar of the guide bushing, which has an internal diameter smaller than the internal diameter of the guide bushing, and the collar of the guide bushing includes a transition surface at a distal end and / or at a dorsal end.

15. SURGICAL DEVICE according to claim 1, characterized in that the felting needle is made of metal and the guide rod is made of injection-molded plastic material that covers the felting needle opposite at least partially to the working tip.

16. SURGICAL DEVICE according to claim 15, characterized in that the force-limiting element and the felting needle are integrally formed and extend through the guide rod.

17. SURGICAL DEVICE according to claim 15, characterized in that the guide rod comprises at least two opposing notches, between which a portion of the force-limiting limb is disposed.

18. SURGICAL DEVICE according to claim 1, characterized by the force limiting element being coupled to the drive mechanism by means of a piston rod.

19. SURGICAL DEVICE according to claim 18, characterized in that the piston rod is linearly oriented in a hole in the frame.

20. SURGICAL DEVICE according to claim 1, characterized in that the frame is at least partially covered by an external housing or the guide rod comprises at least two longitudinally separated guiding surfaces. Petition 870250078729, dated 03 / 09 / 2025, p. 105 / 105

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