Surgical devices, systems, and methods for manufacturing surgical devices

Abstract

To provide a surgical felting device that is safe for both the operator and the patient to use. A surgical device (1) for felting an implant into a patient's soft tissue (46) includes at least one felting needle (2) configured for reciprocating motion and a connection interface (128; 135) for connecting the at least one felting needle to an actuator and transmitting the reciprocating motion from the interface (128; 135) to the at least one felting needle (2). The device includes a needle protection mechanism (3; 20; 135; 242; 331; 451; 553) for preventing the at least one needle from being damaged by contact with a rigid structure during reciprocating motion.

Description

[Technical Field]

[0001] The present invention relates to a surgical device, a system and a method for manufacturing a surgical device according to the preambles of the independent claims. [Background technology]

[0002] The present applicant has recently developed a surgical felting device that allows for biomechanically advantageous implantation of implants. The developed device allows for improved fixation compared to conventional suturing techniques. An example of such a surgical felting device is disclosed in International Application No. PCT / CH2019 / 000015 (Patent Document 1). This surgical felting device includes needles that repeatedly penetrate surgical felt and move into tissue. By embedding strands of felt into the tissue, the needles form a strong, well-distributed mechanical bond between the felt and the tissue. Compared to conventional suturing, this technique is faster and can also reduce side effects such as "cheese-wiring," in which the suture tears through the tissue, which can occur due to localized stress peaks.

[0003] However, surgical felting devices may be handheld, and the high speed at which the needles move increases the risk of needle damage. Damage can occur through collisions between the needle and hard structures such as bone or other surgical instruments. Such collisions can lead to partial needle destruction (plastic bending, breakage, or tearing), which adversely affects functionality. Furthermore, the loss of part of the needle inside the patient's body can pose a health risk. Finally, the high speed of the needle moving through the tissue and surgical felt can generate unwanted heat due to friction. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Application No. PCT / CH2019 / 000015 Summary of the Invention [Problem to be solved by the invention]

[0005] The technical object of the present invention is to overcome the above-mentioned drawbacks of the prior art. In particular, the technical object of the present invention is to provide a surgical felting device that is safe to use for the operator and the patient. A further object of the present invention can be to reduce the heat generated by the felting needles. [Means for solving the problem]

[0006] The above technical problem is solved by the features of the independent claims. One aspect of the invention relates to a surgical device for felting an implant into the soft tissue of a patient. The patient may be a human or an animal. Felting can be understood as the process of repeatedly moving a felting needle into (and in some embodiments, through) a felt-containing implant, thereby entangling the felt fibers. The felting needle can be understood as a needle with barbs that capture the felt fibers and move them through the felt, further entangling the felt fibers. In particular, felting not only entangles the felt fibers that form part of the implant with each other, but also entangles the patient's tissue fibers with the felt fibers. Some strands of the felt may thereby become embedded and entangled in the patient's tissue, and some strands of the tissue may become embedded and entangled in the felt. This results in a well-distributed, strong mechanical bond between the tissue and the felt.

[0007] The surgical device includes at least one felting needle. The at least one felting needle is configured to reciprocate. Reciprocating motion as referred to herein may be understood to mean a repeated back-and-forth motion. This motion may be translational, i.e., linear, or rotational. The surgical device further includes a connection interface that connects the at least one felting needle to an actuator and transmits the reciprocating motion from the interface to the at least one felting needle. The interface may provide a releasable or permanent attachment. For example, releasable interfaces include pins, latches, screws, magnets, or other known mechanical or other connection means. Permanent attachment by rivets, adhesive, or a one-piece design is also possible. Releasable attachment of the at least one needle allows for replacement of the at least one needle.

[0008] In certain embodiments, the device includes a water cooling system to cool the frictional heat generated by the vibrating needle.

[0009] The actuator may be pneumatic, hydraulic, or electromagnetic. In particular, the actuator may be an electric motor, include or utilize an electromagnetic coil, or utilize air or hydraulic pressure. The device may be configured to convert the rotational motion of the actuator into translational motion. In particular, the device may include a scotch yoke mechanism or a piston rod drive mechanism that converts rotational motion into translational motion. This allows for the use of more efficient motors. The speed and / or frequency of the reciprocating translational motion (oscillation) may be adjustable. The device may include a linear rod that transmits reciprocating motion from the interface or actuator to at least one needle. To reduce wear and heating, friction in the linear rod may be minimized using bearings and low-friction materials (e.g., polytetrafluoroethylene).

[0010] At least one needle is preferably made of or includes stainless steel. The needle may include a stainless steel coating. Stainless steel is particularly resistant to the oxidizing conditions of surgery. Thus, the device can be used, for example, in arthroscopic surgery, where saline flushing is routinely performed, which can oxidize the needle.

[0011] The device may include a needle protection mechanism that prevents the at least one needle from being damaged by contact with a hard structure during reciprocation.

[0012] The needle protection mechanism may define a maximum penetration depth of the at least one needle. The maximum penetration depth may be adjustable. In particular, the maximum penetration depth may be less than the amplitude of the reciprocating motion. Additionally or alternatively, the needle protection mechanism may limit the reciprocating motion, may be configured to detect obstructions (i.e., hard tissue), may decouple the actuator from the at least one needle if a collision occurs, or any combination thereof. Motion may be limited by varying the amplitude of the reciprocating motion and / or by limiting the maximum penetration depth.

[0013] The rigid structure may be, for example, a patient's bone or other surgical instrument that may come into contact with the needle during actuation of the needle.

[0014] The surgical device can be used for repair or fixation of anatomical structures such as tendons, meninges, collagenous tissues such as spinal discs or fascia, ligament reconstruction (collateral ligaments, cruciate ligaments, etc.), subcutaneous suturing, skin closure, conventional suturing of skeletal muscle, cardiac muscle, valves, and hollow organs (great blood vessels, bladder, esophagus, and possibly intestine), and implants may be attached to these anatomical structures.

[0015] In one embodiment, the width or diameter of at least one felting needle is less than 0.8 mm, preferably less than 0.6 mm, and most preferably less than 0.4 mm. A smaller diameter needle creates less friction and generates less heat. However, a smaller diameter needle may be more fragile.

[0016] In one embodiment, the needle protection mechanism includes a spacer that contacts the soft tissue or patch to set a maximum predetermined penetration depth for at least one needle. The spacer presses against the tissue, preventing the needle from penetrating beyond the desired extent. This may be particularly useful for anatomical structures located close to bone, such as tendons and spinal discs. Additionally, the spacer helps the operator keep the needle's amplitude of motion within a desired range (e.g., between felt and soft tissue), improving handling.

[0017] The spacer may be resilient, particularly including or forming a spring. Resilient may be understood as allowing the user to change the spacing of the spacer in response to applied force by pressing the device against the soft tissue. In one embodiment, the spacer may have a curved or bent shape. This resilience allows the tip of the device to maintain constant contact with the feltable patch or tissue. This may also help hold the soft tissue in place without the need for additional tools and / or assistance. Without constant contact with the tissue or patch, the tissue or patch may vibrate, potentially reducing needle penetration through the tissue. In particular, the spacer prevents the needle from lifting the patch as it is retracted (a stripping effect). As the needle retracts from the felt and / or tissue, barbs and / or friction may pull the patch toward the surgical device. The spacer prevents this, allowing at least one needle to be withdrawn from the patch and / or tissue without lifting the patch.

[0018] In a preferred embodiment, the spacer includes one or more fingers. Preferably, the spacer includes two, three, or more fingers. One or more fingers include a distal end surface that contacts the soft tissue so that the reciprocating needle does not exceed a predetermined penetration depth. One or more fingers may be bent distally so that the radially outer surface of the finger forms the distal end surface of the spacer. This allows the operator to visually observe at least one felting needle and more precisely control the device. Furthermore, the bent fingers may allow for flexibility of the fingers.

[0019] In some embodiments, the fingers may be connected to one another distally, and in particular may be formed by a single wire. The fingers may be formed from a shape memory alloy, such as Nitinol. The fingers may have compressed and expanded configurations. For example, the fingers may extend from the distal end of a needle guide tube.

[0020] In a preferred embodiment, the spacer forms a slide that allows the needle to slide along the surface of the soft tissue. In particular, one or more fingers may be bent in the same direction. This allows the device to be easily moved over the soft tissue in the direction of the bend while simultaneously maintaining a consistent penetration depth and applying consistent pressure to hold the soft tissue in place. Alternatively, the slide may be formed similarly to slides known from sewing machines.

[0021] In a preferred embodiment, at least one felting needle has a maximum penetration depth. The maximum penetration depth may be adjustable, allowing the device to be adapted to a particular use case. Furthermore, the operator can adjust the penetration depth when operating near hard tissue.

[0022] In a preferred embodiment, the reciprocating motion has an amplitude. The amplitude may be adjustable, allowing the device to be adapted to a particular use case. Furthermore, by adjusting the amplitude, the operator can adjust the maximum penetration depth when operating (too) close to hard tissue.

[0023] In a preferred embodiment, the device includes a guide tube. The guide tube at least partially surrounds the at least one needle and / or translation rod. The translation rod can transmit reciprocating motion from the interface to the at least one needle. The guide tube may be an outer tubular member. Furthermore, the guide tube may be connected in series with a spring or may be elastic.

[0024] In a preferred embodiment, the device may include a scale indicating the current penetration depth. In a preferred embodiment, the device may include a scale indicating the current maximum penetration depth.

[0025] In a preferred embodiment, the needle protection mechanism comprises a needle impact sensor. In a preferred embodiment, the impact sensor is configured to measure the distance to a hard structure. The needle impact sensor may be a distance sensor, such as an ultrasonic sensor. The sensor can measure the distance between the device (particularly the housing or guide tube) and the hard tissue. This allows for the detection of hard tissue or other obstacles that may damage the needle. Furthermore, the device may comprise an indicator to indicate to the operator the detected distance to the hard tissue or other obstacle. The indicator may be optical (i.e., a display or diode), tactile, or acoustic.

[0026] In a preferred embodiment, the needle impact sensor is configured to measure bending of the at least one needle and / or linear rod. The sensor may be an elastic strain sensor, an electromagnetic sensor, and / or a piezoelectric sensor. When the at least one needle impacts hard tissue, such as bone, the needle and / or linear rod may bend before breaking. The needle impact sensor detects this bending. This allows the controller to decouple the needle from the actuator or make a change that reduces the maximum penetration depth.

[0027] In a preferred embodiment, the surgical device includes a controller configured to receive signals from the sensors and adjust the maximum penetration depth of the at least one needle based on measurements from the needle impact sensor, thereby providing an open control loop that allows for rapid automatic adjustment of the penetration depth in response to detecting an impact or threatened impact. In some embodiments, the actuator may measure the current maximum penetration depth using an additional sensor, and the controller may be configured to receive signals from the actuator for closed-loop control of the maximum penetration depth.

[0028] The surgical device may include an actuator that drives the reciprocating motion of at least one needle. In a preferred embodiment, the surgical device includes a coupling adapted to transmit the reciprocating motion from the actuator to the at least one needle. The coupling may be a slipper clutch. A slipper clutch in this context may be understood as a clutch that decouples the needle from the actuator when a threshold force or moment is exceeded. The slipper clutch can at least partially slip when a predetermined force or moment acting on the at least one needle is exceeded. The needle protection mechanism is thereby adapted to decouple the needle from the actuator and prevent damage to the needle in the event of a collision.

[0029] In a preferred embodiment, the slipper clutch includes one or more of a pin and chamfered surface, a ball spring and corresponding recess for receiving a ball, and a spring bearing for at least one needle.

[0030] In a preferred embodiment, the needle protection mechanism includes a predetermined break point that breaks when a force applied to the at least one needle exceeds a predetermined threshold, which may be less than the force required to break the needle.

[0031] In preferred embodiments, the predetermined break point is part of a mechanical coupling that transmits force to at least one needle. The mechanical coupling preferably includes a rod having a predetermined break point. In some embodiments, the predetermined break point may be provided by a structural weakening such as a taper, ridge, edge, or recess. In other embodiments, the predetermined break point is part of at least one needle.

[0032] In a further embodiment, the device is configured to detect a broken needle. In particular, the needle may be part of an electrical circuit or may include a needle strike sensor as described above. Additionally, the device may include an indicator, such as a warning light, configured to provide an optical, tactile or acoustic indication that the needle is broken.

[0033] A further aspect of the invention relates to a system comprising a surgical device as described above and an actuator, which may in particular be an electric motor that drives at least one needle in a reciprocating motion.

[0034] A further aspect of the present invention relates to a method of manufacturing a surgical device. Preferably, the surgical device is a surgical device as described above. The method comprises: - providing a surgical device comprising at least one felting needle configured to reciprocate and a connection interface connecting the at least one felting needle to an actuator and transmitting the reciprocating motion from said interface for the actuator to the at least one needle; - providing a needle protection mechanism to prevent at least one needle from being damaged by contact with a hard structure during reciprocation; Includes. [Brief explanation of the drawings]

[0035] Non-limiting embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] 1 is a schematic perspective view showing a first embodiment of a surgical device according to the present invention. [Figure 2A] 2A-2C show further details of the adjustable maximum penetration depth of the surgical device according to FIG. 1. [Figure 2B] 2A-2C show further details of the adjustable maximum penetration depth of the surgical device according to FIG. 1. [Figure 3A] 2A-2C show an alternative embodiment of the distal tip of the surgical device of FIG. 1. [Figure 3B] 2A-2C show an alternative embodiment of the distal tip of the surgical device of FIG. 1. [Figure 4] FIG. 1 is a schematic perspective view showing a second embodiment of a surgical device according to the present invention. [Figure 5] FIG. 5 shows a cross section of the surgical device according to FIG. [Figure 6A] 1 illustrates an interface for an actuator of a surgical device according to the present invention. [Figure 6B] 1 illustrates an interface for an actuator of a surgical device according to the present invention. [Figure 7A] 10A-10C show further interfaces for actuators of a surgical device according to the present invention. [Figure 7B]10A-10C show further interfaces for actuators of a surgical device according to the present invention. [Figure 8] FIG. 10 shows a cross section of a distal portion of a third embodiment of a surgical device according to the present invention. [Figure 9] FIG. 10 shows a cross-section of a distal portion of a fourth embodiment of a surgical device according to the present invention in a first position. [Figure 10] 10 shows a cross-section of a distal portion of the surgical device of FIG. 9 when in a second position. [Figure 11] FIG. 10 shows a cross section of a distal portion of a fifth embodiment of a surgical device according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0036] FIG. 1 is a perspective view of a surgical device 1 according to a first embodiment of the present invention. The surgical device 1 comprises a housing 5 and a guide tube 3 extending from the housing 5. A felting needle 2 is disposed within the guide tube 5 and extends from the end of the guide tube 5. The felting needle 2 can be reciprocated back and forth along the axis of the felting needle and the axis of the guide tube 3. The surgical device 1 comprises a handle 10 including a grip portion 7. Furthermore, the surgical device 1 is connected to an energy source having a power cord 9 leading to the surgical device.

[0037] An actuator (here, an electric motor 8) is disposed within the housing 5 of the surgical device 1. The motor 8 drives the reciprocating motion of the needle 2. The guide tube 3 can be moved relative to the needle 2 using a wheel 4. Turning the wheel 4 retracts the guide tube 3 distally, exposing the tip of the needle 2. Turning the wheel 4 in the opposite direction pushes the guide tube 3 proximally, covering the tip of the needle 2. As a result, the needle penetration depth during reciprocating motion depends on the relative position of the guide tube. For example, even if the needle 2 has a 25 mm amplitude of movement, if the guide tube is only retracted 10 mm from its most distal position during reciprocating motion, the maximum needle penetration depth is only 10 mm. In this specification, proximal and distal are understood from the operator's perspective. That is, distal refers to a direction away from the operator, and proximal refers to a direction toward the operator.

[0038] Setting the guide tube 3 relative to the needle 2 limits the maximum needle penetration depth, allowing the operator to avoid felting of tissue deep below the implantation site and to avoid collisions with hard tissue, especially bone. Additionally, the guide tube 5 protects the needle 2 during shipping and unpacking of the device. The guide tube 5 is embedded in a guide plug 6 (see FIG. 1) and may be connected in series with a spring (see, e.g., FIG. 5).

[0039] FIG. 2A shows the relative movement of the guide tube 3 in more detail. The wheel 4 includes a ridge 12 to allow the operator to grip the wheel more easily. Additionally, the wheel includes an indicator 11 that indicates the current position of the guide tube 3. In the illustrated example, the numbers on the wheel indicate the maximum exposed needle length, i.e., the maximum penetration depth. Additionally, the guide tube 3 itself includes a penetration depth scale 13. The penetration depth scale 13 is realized as a marking on the outer surface of the guide tube 3. In this example, the marking is a circular ring around the guide tube 3. When the guide tube 3 is retracted, the current penetration depth can be read from the last ring still visible, i.e., the last ring not retracted into the housing 5. The depth scale indicates the current penetration depth. If the guide tube 3 is directly retracted as a result of movement of the wheel 4, the current penetration depth and the maximum penetration depth are the same. However, in some embodiments, these two may be different, as will be explained with reference to the second embodiment.

[0040] The relative movement of the guide tube 3 is indicated by the arrows in Figures 2A and 2B. As the operator turns the wheel counterclockwise, the guide tube 3 retracts, exposing the indicated maximum penetration depth 16.

[0041] 3A and 3B show additional embodiments of the guide tube 3, which can be used independently or in combination with the retractable guide tube 3. In the embodiment of FIG. 3A, the guide tube 3 includes a protective fork 20 at its distal end 24, with two fingers 21. The fingers 21 extend from the distal end and are bent near a curved portion 22. In use, the distal end faces of the fingers 21 contact the patient's soft tissue and, similar to the ends of the guide tube 3 in the previous embodiments, define the penetration depth 16. The curvature of the fingers 21 assists in smoothing the surgical device 1 along the currently felted felt and / or soft tissue, allowing the surgical device to glide smoothly over the soft tissue.

[0042] In the embodiment of Figure 3B, the protective fork is formed by a wire made of a shape memory alloy. During transport, the wire is held within the guide tube. Before operation, the wire emerges from the distal end 24 of the guide tube and assumes a bent position as shown on the right side of Figure 3B.

[0043] When the operator pushes distally, the bent wire or bent fingers may act as a spring, allowing temporary (depending on force) greater penetration depth as needed.

[0044] Figures 4 and 5 show a second embodiment of a surgical device 101 according to the present invention. Figure 4 shows a perspective view of the surgical device 101, and Figure 5 shows a cross-sectional view of the surgical device 101. Generally, like reference numerals are used herein for like features and are incremented by 100. For example, the felting needle 2 may be similar to the felting needle 102 of the embodiment shown in Figure 4.

[0045] Similar to the first embodiment described above, the surgical device 101 of the second embodiment includes a felting needle 102, a guide tube 103, a plug 106, a wheel 104 for retracting the guide tube 103, and a housing 105. A power cord 109 is connected to the housing 105.

[0046] As can be seen in FIG. 5 , the surgical device 101 includes a motor 108. The motor 108 drives a shaft, the rotation of which is transmitted to a scotch yoke 128 via a gear unit 126. The scotch yoke 128 converts the rotational motion of the motor 108 into translational motion. The scotch yoke 128 of one embodiment can be seen in detail in FIGS. 6A and 6B . The scotch yoke 128 converts the rotational motion into linear motion and transmits the linear motion to a translation rod 119 held within the guide tube 103. The translation rod 119 is guided by a bearing 129. The needle 102 is disposed at the distal end of the translation rod 119 and reciprocates. The amplitude of the motion is determined by the scotch yoke 128, and the frequency of the reciprocating motion is determined by the motor 108.

[0047] The surgical device 101 also includes a wheel 104. The wheel 104 includes an internal thread 130 that engages with the external thread of the insert 132. The outer tube 103 covers the translation rod 119, and the distal end of the outer tube is covered with a distal tip 125. The proximal side and end of the guide tube 3 include a plug 106. The plug 106 is also connected along its axial direction to a spring 131, thereby disposing the spring 131 between the plug 106 and the insert 132. During operation of the surgical device 101, the operator may press the distal tip with the felting needle 102 against the felt, thereby pushing the outer tube 103 proximally. The spring 131 resists this movement, requiring the operator to push against the spring. The outer tube 103 thereby covers the sharp needle 102 when the device is not in use.

[0048] Additionally, the wheel 104 can be used to move the insert 132 back and forth. The insert defines a maximum width 127 that the outer tube 103 is retracted to. The maximum retraction width 127 therefore corresponds to a maximum penetration depth of the needle 102. Because hard tissue (e.g., bone tissue) may be located underneath the soft tissue, defining the maximum penetration depth protects the needle 102 from impact with the hard tissue. Setting the maximum penetration depth as described above is advantageous when felting various tissues that are underlain by hard tissue (e.g., 8mm rotator cuff or 12mm Achilles tendon).

[0049] In addition to its protective function, spring 131 may allow for constant contact of the tip of the device with the feltable patch or respective tissue. Without constant contact with the tissue or felt, the tissue may vibrate, minimizing needle penetration through the tissue.

[0050] 6A and 6B show an embodiment of the Scotch yoke 128 in detail. The Scotch yoke can form an interface or a coupling. The Scotch yoke 128 includes a wheel 135. The wheel 135 is driven by the motor 108 via a hex socket 144 and rotates in a direction 134. A pin 136 is disposed on the radially outer portion of the wheel. The Scotch yoke further includes a slider 138. The slider 138 includes a slot 139 through which the pin 136 moves. As the wheel rotates, a linear force is transmitted along the axis of the translation rod 119, as indicated by arrow 137, but the slot 139 prevents forces transverse to this direction from being transmitted.

[0051] 6B is an embodiment illustrating an example of mechanical uncoupling between the needle 102 and the motor 108. The slider 138 may include a chamfer 133 in the slot 139. If excessive forces are applied to the needle 102, these forces are transmitted to the scotch yoke 128 through the linear rod and slider. The chamfer 133 glides smoothly over the pin, thereby lifting the slider 137 off the pin 136 and preventing further force from being applied to the needle 102. Thus, the wheel 135 and the slider 138 are mechanically decoupled.

[0052] In a further example, an electromagnetic motor 108 may be used, where the amplitude of the needle 102 can be adjusted if the motor detects a force on the needle 102 that exceeds a threshold. If the force on the needle 102 exceeds the electromagnetic force of the linear drive, the needle may be retracted, or the motor may simply be stopped.

[0053] Further mechanical separation is shown in Figures 7A and 7B. Figures 7A and 7B show wheel 235, which is an alternative embodiment to wheel 135 of Figures 6A and 6A. Wheel 235 includes two parts: an inner wheel 240 and a concentric outer wheel 241. Figure 7A is an exploded view of wheel 235, and Figure 7B shows wheel 235 assembled. Like wheel 135, wheel 235 includes a hex socket 244 and a pin 236. Inner wheel 240 is coupled to the outer wheel with ball 242, which is urged radially outward by a spring (not shown). Outer wheel 241 includes a recess 243 for ball 242 along its inner circumference. When the inner wheel 240 is set on the inner circumference of the outer wheel 241, the ball 242 is pushed radially inward against the force of the spring and, if properly aligned, latches into the recess 243. As long as the ball 242 is in the recess 243, force is transmitted from the motor 108 to the needle 102. However, if the needle 102 collides with hard tissue, the ball 242 is forced inward and no force above a threshold is transmitted, thereby decoupling the two wheels 240 and 241 from rotation to rotation.

[0054] Alternatively, the ball spring and recess can be replaced with a weak link or latch that breaks if too much force is applied. The latch can be a spring or other compliant mechanism. Yet another option is a finely tuned magnet that disengages when needed and re-engages when the force falls below a threshold. In other embodiments, the system can be electromechanical, with force sensors or other sensors (e.g., needle strain, conductivity) detecting when the force on the needle exceeds a threshold. These sensor signals can cause a controller to disconnect the needle from the actuator or shut down the actuator.

[0055] A third embodiment of a surgical device 301 according to the present invention is shown in FIG. 8 . The surgical device 301 includes a guide tube 303 and a needle 302 having a maximum penetration depth 316. As can be seen in FIG. 8 , the needle is moved back and forth within the soft tissue 46. The needle 302 is driven in a linear motion 337 by a translation rod 319. The translation rod 319 is guided by a bearing 329. The surgical device 301 further includes an ultrasonic distance sensor 331. The ultrasonic distance sensor 331 is disposed at the distal end of the guide tube and can measure the distance between the distal end of the guide tube 303 and the bone tissue 47. The measured distance may be reported to the user via an audio, optical, or vibration cue, allowing the user to set the maximum penetration depth 316. For example, the maximum penetration depth can be set as described above with reference to FIGS. 1 through 5 . Alternatively, the surgical device 301 may additionally include a controller that automatically adjusts the maximum penetration depth 316 to be less than the measured distance.

[0056] A fourth embodiment of a surgical device 401 is shown in FIGS. 9 and 10. Similar to surgical device 301, surgical device 401 includes a guide tube 403, a bearing 429, and a translation rod 419 that moves along a linear motion 437. Translation rod 419 is connected to a needle 402. However, the needle 402 is not directly connected to the translation rod 419. Instead, the translation force of the translation rod 419 is transmitted to the needle 402 via a spring 451 and a piston cylinder 450. The spring 451 and the cylinder 450 are disposed within a cavity 452 of the translation rod 419. Alternatively, the spring 451 and the cylinder 450 may simply be disposed at the end of the translation rod 419. In normal operation, the needle 402 follows the movement of the translation rod 419. However, if the needle 402 impacts a hard object, the spring 451 compresses and absorbs the excess force (see FIG. 10). Additionally, a damping element may be provided in parallel or series with the spring to prevent unwanted vibration of the spring 451. In some embodiments, the spring may be formed by an elastically deformable rod (e.g., a nitinol band).

[0057] A fifth embodiment of a surgical device 501 is shown in FIG. 11. The surgical device 501 may be similar to the surgical device 401 shown in FIGS. 9 and 10. However, instead of a spring, the translation rod 519 is connected to the needle 502 at a connecting rod 554 and a predetermined break point 553. The connecting rod 552 may be an elastically deformable rod coupled to an element featuring the predetermined break point 553. The predetermined break point 553 may be formed by means known in the art, such as an edge, a ridge, or a different material. When the needle 502 impacts the bone tissue 47, the connecting rod 554 deflects. This deflection converts the translation force into a shear force at the predetermined break point 553. The greater the deflection of the rod, the greater the shear force at the predetermined break point 553, resulting in a greater likelihood of fracture. The present disclosure includes the following aspects as embodiments. [Aspect 1] A surgical device (1) for felting an implant into soft tissue (46) of a patient, comprising: A surgical device (1) comprising at least one felting needle (2) adapted for reciprocating movement and a connection interface (128; 135) for connecting said at least one felting needle to an actuator and transmitting the reciprocating movement from said interface (128; 135) to said at least one felting needle (2), the device comprises a needle protection mechanism (3; 20; 135; 242; 331; 451; 553); A surgical device (1), characterized in that the needle protection mechanism is configured to prevent the at least one needle from being damaged by contact with a hard structure during reciprocation. [Aspect 2] A surgical device (1) according to aspect 1, wherein the width or diameter of the at least one felting needle is less than 0.8 mm, preferably less than 0.6 mm, and most preferably less than 0.4 mm. Aspect 3 A surgical device (1) according to aspect 1 or 2, wherein the needle protection mechanism includes a spacer (3; 20) that contacts the tissue to set a predetermined penetration depth of the at least one needle. Aspect 4 A surgical device (1) according to aspect 3, wherein the spacer (3; 20) comprises one or more fingers (20), preferably two fingers (20), and the one or more fingers include a distal end surface that contacts the tissue so that the reciprocating movement of the needle does not exceed the predetermined penetration depth. Aspect 5 A surgical device (1) according to aspect 4, wherein the spacer (20) forms a slide that allows the needle to slide along the surface of the soft tissue. Aspect 6 A surgical device (1) according to any one of aspects 1 to 5, wherein the at least one felting needle has a maximum penetration depth (16), and the maximum penetration depth is adjustable. Aspect 7 A surgical device (1) according to any one of aspects 1 to 6, wherein the needle protection mechanism comprises a needle impact sensor (331), the needle impact sensor preferably configured to measure a distance to a rigid structure. Aspect 8 In the surgical device (1) described in aspect 7, the needle collision sensor is configured to measure the bending of the at least one needle (2), and the sensor is preferably an electrostriction sensor, an electromagnetic sensor, or a piezoelectric sensor. Aspect 9 A surgical device (1) according to aspect 7 or 8, wherein the surgical device comprises a controller, and the controller is configured to adjust the penetration depth (16) of the at least one felting needle based on measurements of the needle collision sensor (331). Aspect 10 A surgical device (1) according to any one of aspects 1 to 9, comprising a coupling (128; 235) adapted to transmit reciprocating motion from the actuator (8) to the at least one needle (2), and the needle protection mechanism is adapted to decouple the needle (2) from the actuator (8) and prevent the needle from being damaged by decoupling the coupling. Aspect 11 In the surgical device (1) described in aspect 10, the needle protection mechanism includes a slipper clutch (235), and the slipper clutch (235) at least partially slips when a predetermined force or moment acting on the at least one needle is exceeded. Aspect 12 12. The surgical device (1) according to claim 11, wherein the slipper clutch is: pins and chamfered surfaces; a ball spring and a corresponding recess for receiving the ball; and a spring bearing for said at least one needle A surgical device (1) comprising one or more of: Aspect 13 13. The surgical device of claim 1, wherein the needle protection mechanism includes a predetermined break point, and the predetermined break point breaks when a force on the at least one needle exceeds a predetermined threshold; the predetermined breaking point is preferably part of a mechanical coupling (553) that transmits force to the at least one needle; The surgical device (1), wherein the mechanical coupling preferably includes a rod having the predetermined break point. Aspect 14 a surgical device according to any one of aspects 1 to 13; and an actuator (8), in particular an electric motor, for driving said at least one needle in a reciprocating motion; A system including (1). Aspect 15 13. A method for manufacturing a surgical device (1), preferably a surgical device according to any one of aspects 1 to 12, comprising: - providing a surgical device (1) comprising at least one felting needle (2) adapted to reciprocate and a connection interface (128; 135) for connecting said at least one felting needle to an actuator (8) and for transmitting a reciprocating movement from said interface (128; 135) for said actuator to said at least one needle (2); - providing a needle protection mechanism (3; 20; 135; 242; 331; 451; 553) for preventing said at least one needle from being damaged by contact with a hard structure during reciprocation; A manufacturing method comprising:

Claims

1. A surgical device (1) for felting an implant into a patient's soft tissue (46), comprising: A surgical device (1) comprising at least one felting needle (2) adapted for reciprocating movement and a connection interface (128; 135) for connecting said at least one felting needle to an actuator and transmitting the reciprocating movement from said interface (128; 135) to said at least one felting needle (2), the device comprises a needle protection mechanism (3; 20; 135; 242; 331; 451; 553); The needle protection mechanism detecting a distance to an obstacle and adjusting a maximum penetration depth of the at least one felting needle based on the distance; and decoupling said actuator from said at least one felting needle in the event of a collision; A surgical device (1) configured to perform at least one of the following:

2. 2. The surgical device (1) according to claim 1, wherein the width or diameter of said at least one felting needle is less than 0.8 mm.

3. 3. The surgical device (1) according to claim 1 or 2, wherein the needle protection mechanism comprises a spacer (3; 20) that contacts the tissue to set a predetermined penetration depth of the at least one felting needle.

4. 4. The surgical device (1) according to claim 3, wherein the spacer (3; 20) comprises one or more fingers (20), the one or more fingers including a distal end surface that contacts the tissue so that the reciprocating movement of the at least one felting needle does not exceed the predetermined penetration depth.

5. 5. The surgical device (1) of claim 1, wherein the needle protection mechanism comprises a needle impact sensor (331), the needle impact sensor configured to measure a distance to a rigid structure.

6. 5. The surgical device (1) according to any one of claims 1 to 4, wherein the needle protection mechanism comprises a needle collision sensor (331), the needle collision sensor being configured to measure bending of the at least one felting needle (2).

7. 7. The surgical device (1) according to claim 5 or 6, comprising a controller, the controller configured to adjust the penetration depth (16) of the at least one felting needle based on measurements of the needle impact sensor (331).

8. 8. The surgical device (1) according to claim 7, wherein the needle protection mechanism comprises a slipper clutch (235) disposed between the at least one felting needle and the actuator, wherein the slipper clutch (235) at least partially slips when a predetermined force or moment acting on the at least one felting needle is exceeded, or The slipper clutch is pins and chamfered surfaces; a ball spring and a corresponding recess for receiving the ball; and a spring bearing for said at least one felting needle; A surgical device (1) comprising one or more of:

9. 9. The surgical device (1) according to any one of claims 1 to 8, wherein the needle protection mechanism includes a predetermined breaking point, and the predetermined breaking point breaks when a force applied to the at least one felting needle exceeds a predetermined threshold.

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