Apparatus for surgical fastening

0001The present invention relates to surgical fixation methods and devices.

0002Surgical fixtures are widely used in many different medical procedures. For example, staples, sutures, clips and other fixtures are commonly used in laparoscopic and open surgical procedures to secure two or more parts of tissue, artificial organs, or other materials to each other. Has been done. Fixtures provide a permanent connection between two parts, such as between a bone and a non-resorbable prosthesis, or a temporary, such as between a mesh prosthesis and muscle or other tissue. Immobilization can be provided to allow tissue indwelling or other adhesion processes and more reliably anchor the mesh to the tissue.

0003For example, Jervis US Patent Publication No. 2004/0049227 discloses a spiral fixture and applicator that attaches an artificial organ to tissue, eg, a mesh artificial organ in a hernia repair procedure. The applicator disclosed to Jervis uses a rotating body to deploy one or more fixtures with a spiral wire coil shape to rotate the fixture and release it from the distal end of the applicator. be able to. In one embodiment, a stationary ballast installed within the inner portion of the coil fixture has a threaded shape that engages the fixture and, when the fixture is rotated, delivers it distally.

<p num="0004"> In particular, other fixtures used to secure the mesh in surgical procedures such as hernia repair are disclosed in Kayan's US Patent Publication No. 2004/0204723 and Criscuolo's US Patent Publication No. 2005/0171562. There is. In both Kayan and Criscuolo, the fixture includes a threaded structure and head in a screw-like structure. Also, these fixtures are said to be made of absorbent material. Therefore, the fixture can be disassembled and absorbed by the body after the surgical procedure is complete.</p>

<p num="0005"> In one aspect of the invention, the surgical fixture comprises a torso portion, the spiral thread extending from near the distal end of the torso portion toward the proximal end of the torso portion. The head portion can be installed at the proximal end of the torso portion and the through hole can extend through the head portion and the torso portion. The through hole includes a threaded portion, and the body portion and the head portion can be formed of a bioabsorbable material. In one embodiment, the through hole can have an unthreaded portion located at the proximal end of the through hole. The threaded portion is installed at the distal end of the through hole and the unthreaded portion can extend over about half the length of the through hole. The head portion of the fixture can include at least one drive mechanism adapted to engage the driver to rotate the fuselage portion and enter the tissue. For example, at least one drive mechanism can include opposed flat portions on the side of the head portion.</p><p num="0006"> In another aspect of the invention, the surgical fixture comprises a torso portion having a vertical axis and a spiral thread extending from near the distal end of the torso portion to the proximal end of the torso portion. At least part of the distal end of the torso is located on a plane that traverses the vertical axis. The head portion is attached to the proximal end of the torso portion and can have a maximum width greater than the maximum width of the torso portion. The through hole can extend along the vertical axis through the head portion and the torso portion, and the torso portion and the head portion can be formed of a bioabsorbable material. In one embodiment, the distal end of the torso can have a plane inclined with respect to the vertical axis.</p><p num="0007"> In another aspect of the invention, the surgical fixture can include a torso portion having a vertical axis and a spiral thread extending from near the distal end of the torso portion to the proximal end of the torso portion. The head portion is attached to the proximal end of the torso portion and can have a maximum width greater than the maximum width of the torso portion in the radial direction. The opposite side of the head portion can have a curved recess adapted to engage the rotating body and rotate the fixture around the vertical axis during deployment. The through hole extends along the vertical axis through the head portion and the torso portion, and the torso portion and the head portion can be formed of a bioabsorbable material.</p><p num="0008"> In another aspect of the invention, the surgical fixture system can include a torso portion having a male thread and a plurality of fixtures each extending through the torso portion and having a through hole having a female thread portion. .. A mandrel having a threaded portion may be adapted to engage the threaded portion of the through hole of the plurality of fixtures so that the rotating body moves at least one fixture along the mandrel. It may be adapted to engage at least one of the tools and rotate it. As the fixture moves along the mandrel, the fixture can unfold into tissue or other material. In one embodiment, the mandrel can have a distal tip and the mandrel may be movable to extend the distal tip beyond the distal end of the rotating body. The system can include an outer tube with at least a part of the rotating body and mandrel installed inside. The female threaded portion of each of the plurality of fixtures can be installed in the distal portion of the through hole, and the proximal portion of the through hole may be threadless. The system can include a handle at the proximal end of the mandrel and the rotating body, which can include at least one trigger arranged to operate the rotating body.</p><p num="0009"> In another aspect of the invention, the method of deploying the fixture comprises providing a plurality of fixtures mounted on a threaded mandrel, each fixture passing through a torso portion having a male thread and a torso portion. Has a through hole that extends and has a female threaded portion. At least one of the fixtures can be rotated relative to the mandrel to deploy at least one fixture from the distal end of the mandrel. In one embodiment, a fixture attached to a threaded mandrel can be housed in the tube and the distal end of the mandrel can be extended outside the distal end of the tube. The tube can rotate to rotate the fixture that engages the tube. The distal end of the mandrel may be sharp and the sharp distal end of the mandrel can extend into the material. At least one fixture can be deployed from the distal end of the mandrel after the distal end extends into the material.</p><p num="0010"> The above and other aspects of the invention will become apparent from the following description and claims.</p><p num="0011"> Embodiments of the present invention will be described below with reference to exemplary embodiments. Here, similar numbers indicate similar elements.</p>

0012It should be understood that the embodiments of the present invention will be described herein with reference to the figures, and those figures represent exemplary embodiments according to the embodiments of the present invention. The exemplary embodiments described herein do not necessarily represent all aspects of the invention, but rather are used to illustrate some exemplary embodiments. Therefore, the embodiments of the present invention shall not be construed in a narrow sense in view of the exemplary embodiments. Further, it should be understood that aspects of the invention can be used alone or in any suitable combination with other aspects of the invention.

0013In one aspect of the invention, the fixture application system comprises a torso portion having a male thread and a plurality of fixtures each comprising a through hole extending through the torso portion, eg, along the longitudinal axis of the torso. Can be done. The fixture can include a torso and / or a head that may be wider than the male screw of the torso, respectively. The fixture can be placed along the mandrel, which has a threaded portion and extends through the through hole of the fixture. At least a portion of the through hole of each fixture can have a female threaded portion that engages the threaded portion of the mandrel. A rotating body, such as a tube extending over the fixture, engages and rotates the fixture, which allows the fixture to move along the mandrel. That is, the mandrel remains stationary and the rotating fixture can move forward along the mandrel by engaging the female threaded portion of the fixture with the threaded portion of the mandrel.

0014The fixture system can be used, for example, to deploy the fixture in the tissue of interest or other material to secure the mesh to muscle tissue in a hernia repair procedure. To deploy the fixture, the anterior or distal end of the mandrel can first be placed next to the material of interest. In one exemplary embodiment, the mandrel can be inserted into the material of interest, for example, the pointed end of the mandrel can be inserted into the material of interest. The rotating body can rotate the fixture installed at least closest to the distal end of the mandrel so that the fixture is advanced distally along the mandrel and placed within the material of interest. Other fixtures on the mandrel can also rotate to deliver the fixture towards the distal end of the mandrel as the most distal fixture is deployed. As the most distal fixture rotates, the male thread on the fuselage of the fixture engages with the material of interest (eg, mesh, tissue and / or other) and the fixture can be pulled into the material. The head provided on the fixture can help mount the fixture on the material surface, hold two or more materials together, and / or prevent over-insertion of the fixture into the material.

0015FIG. 1 shows a fixture applier 100 and related fixtures of an exemplary embodiment. The applier 100 includes a handle 1 and a shaft 2 extending distally from the handle 1. The shaft 2 accommodates a plurality of fixtures 4 on the rotating body 3 and the mandrel 5. The trigger on the handle 1 or another actuator 6 can be operated by the user so that the rotating body 3 rotates at least the most distal fixture 4 with respect to the mandrel 5 and unscrews the fixture 4. The fixture 4 can be driven distal to the mandrel 5 by engaging with the screw of the mandrel 5. The operation of the actuator 6 serves to move the mandrel 5 distal to the rotating body 3 and / or the shaft 2, so that, for example, the pointed end of the mandrel 5 is exposed from the distal end of the shaft 2. .. When the most distal fixture 4 is deployed, the mandrel 5 can retract into the shaft 2.

0016The rotating body 3 can take any suitable form for rotating the fixture 4 with respect to the mandrel 5. In this embodiment, the rotating body 3 has a tubular shape with a substantially elliptical cross section, as seen in FIG. The flat surface 31 of the rotating body 3 can engage the corresponding surface of the fixture 4, for example, the flat side of the head of the fixture 4, yet the fixture 4 still has the mandrel 5 relative to the rotating body 3. Can be moved axially along. The circular portion of the rotating body 3 can be in close contact with the inner surface of the shaft 2, for example, to help prevent the rotating body 3 from wobbling in the shaft 2 during rotation. However, it should be understood that the rotating body 3 can have any suitable arrangement configuration. For example, the rotating body 3 can have a hexagonal, square, star or other cross section to engage the corresponding surface of the fixture 4. Additional or alternative, the rotating body 3 can have one or more ribs, splines, tabs, grooves or other structures that engage and rotate the fixture 4. In other embodiments, the rotating body 3 does not need to have a tubular structure and can be otherwise engaged with the fixture. For example, the rotating body 3 can have one or more claws extending longitudinally through the shaft 2 and through the corresponding holes or grooves of the fixture 4. As the claws rotate around the mandrel 5, the fixture 4 can rotate to unfold. In another configuration, the rotating body 3 may include gears that extend along one side of the shaft 2. The gear can partially extend into the inner surface of the shaft 2 and come into contact with the fixture 4. As the gear rotates, the fixture, which can have the teeth of a complementary gear formed on the head to engage with the gear, rotates and the fixture unfolds as described above. In other arrangements, the rotating body 3 can rotate only the most distal fixture 4, and the trailing fixture can be sent forward by other means, such as a spring. For example, the mandrel 5 only needs to include a threaded portion near the distal end of the shaft. The proximal part of Mandrel 5 is a smooth circle

00173 to 5 show the fixtures deployed by the applier 100 of FIG. In FIG. 3, the user can place the distal end of the shaft 2 against a target material, eg, a mesh prosthesis 81 placed on muscle tissue 82. At this point, the mandrel 5 and the most distal fixture 4 can be located within the shaft 2 (but in other embodiments, the mandrel and / or the fixture 4 can be exposed). When the applier 100 is activated, the mandrel 5 first extends outward of the distal end of the shaft 2 and thus the mandrel 5 plunges into the mesh 81 and / or tissue 28. In this embodiment, the mandrel 5 has a sharpened tip to aid in perforation of the material of interest, but the distal end of the mandrel has a threaded cone shape, a conical tip, a blunt end, etc. Arrangement configuration of is also possible. Alternatively, the mandrel 5 does not plunge into the material of interest, for example, in embodiments where the mandrel 5 does not extend distally from the shaft 2, it can simply be pressed against the material or placed next to the material. .. In this embodiment, the mandrel 5 extends into the target material without rotating, but in some embodiments, the mandrel 5 rotates while drilling the target material, eg, to help enter the material. Can be done. The rotating body 3 may be stationary while the mandrel 5 extends distally, so as the mandrel 5 extends, the fixture 4 engaged with the screw of the mandrel 5 rotates with the mandrel 5. It slides distally to body 3. (For example, in addition to or instead moving the mandrel 5 distally, pressing the distal end of the shaft 2 against the material, etc., the distal end of the shaft 2 and / or the rotating body 3 in the proximal direction. It should be understood that the mandrel 5 can be exposed from the distal end of the shaft 2 by retracting.)

0018The rotating body 3 can be rotated around the mandrel 5 with the mandrel 5 extending into the material as shown in FIG. This causes the fixture 4 to rotate relative to the mandrel 5 (which remains stationary in the direction of rotation) and to move distally on the screw of the mandrel. When the distal tip of the most distal fixture 4 emerges from the shaft 2, the fixture 4 plunges into mesh 81 and tissue 82. Due to the screw engagement between the fixture 4 and the mandrel 5, in addition to the fixture 4 moving distally as the rotating body 3 rotates, the male screw of the fixture 4 engages the mesh 81 and tissue 82. , Can help pull the fixture into the material. When the fixture 4 is properly rotated, the fixture 4 is fully inserted into the material as shown in FIG. In this embodiment, the proximal portion of the through hole of the fixture 4 does not engage the threaded portion of the mandrel 5, for example, there is a female thread only in the distal portion of the through hole, and the proximal portion has a smooth cylindrical shape, or It has other configurations that do not engage the mandrel screws. As a result, the fixture 4 is disengaged from the mandrel 5, the mandrel 5, the rotating body 3 and the shaft 2 can be pulled out of the tack, and the fixture 4 can be deployed from the applier 100. The mandrel 5 can be retracted into the position shown in FIG. 3 in the shaft 2 and ready to deploy the next fixture in the applier 100.

0019The fixture 4 used with the applier 100 can have any suitable arrangement configuration, as can be understood by those skilled in the art. 6 to 10 show various views of the fixture 4 in an exemplary embodiment. FIG. 6 shows a side view of the fixture 4, which has a head 41, an outer spiral screw 42 and a body portion 43. The head 41 can have any suitable shape and / or size, and in this embodiment has an overall flat distal surface near the screw 42 and a rounded proximal surface. The male screw 42 can have a diameter d close to the size of the head 41 in the figure shown in FIG. Male screw 42 is about 3. around the body part 43. It can rotate 5 times, but in other embodiments, the screw 42 can rotate less or more. The male screw 42 may be tapered near the distal end of the torso portion 43. This taper helps the fixture plunge into the target material, such as mesh 81. In this embodiment, the screw 42 does not taper at the proximal end of the body portion 43 and maintains a relatively constant diameter until the point where the screw 42 joins the head 41. In other embodiments, the screw 42 is tapered at or in front of the head 41 and can have, for example, a peak height of zero. When the screw 42 extends to the head 41, it can help remove the fixture 4 from a material such as mesh 81 by simply rotating the fixture 4 in the opposite direction. On the other hand, such a threaded arrangement allows the fixture 4 to be "overdriven" and the mesh 81 or other material to pass through to an undesired depth. A gap between the most proximal end of the screw 42 and the head 41 helps to stop the insertion of the fixture on the material surface, and some material, such as mesh 81, is threaded between the screw 42 and the head 41. It can also be captured between 41. Other variants of the male screw 42 can be created. For example, different thread pitches, variable thread pitches, different thread surface angles (front and / or rear), thread top shapes (pointed, flat as shown, rounded, etc.), two or more threads, and so on. The male screw 42 can also have the most distal portion of the screw 42 extending anterior to the body portion 43, which, for example, is a screw cone, hook or claw that helps guide the fixture 4 into the material. Form a part. In short, in some aspects of the invention any suitable arrangement of male threads 42 can be used.

0020In one aspect of the invention, the torso portion can have an inclined front 431 or an oval leading edge. For example, as shown in FIG. 6, the torso portion 43 can have an inclined distal end. If the torso 43 has a cylindrical or conical shape, the torso 43 has an elliptical anterior edge as a result of the inclined distal end. This arrangement can help the fixture 4 plunge into the material. This is because, for example, only the tip of the distal end of the torso 43 first plunges into the material and guides the trailing portion of the distal end. Other arrangement configurations of the distal end of the tack are possible, including a "fish mouth" type configuration in which the distal end of the torso 43 has a "V" -shaped notch. Alternatively, the distal end of the torso 43 can have a sharp anterior edge that helps plunge into the material.

00217 and 8 show bottom and top perspective views of the fixture 4. In this embodiment, the head 41 of the fixture 4 includes an opposed flat side surface 411 that engages the flat surface 31 of the rotating body 3. The screw 42 also includes a flat portion 421, which can be in contact with the surface 31 of the rotating body 3 to help stabilize the fixture 4 within the rotating body 3, for example. The flat portion 421 is screwed, for example, while keeping the diameter d of the screw 42 smaller than the distance between the side surfaces 411 of the head 41 so that the fixture 4 can be fitted within the rotating body 3. It can also help maximize the height of the 42 peaks. Further, the head 41 may include a curved recess 412 on the opposite side of the head 41. These curved recesses 412 can help align the plurality of fixtures 4 properly when assembling the fixtures 4 for loading into the system 100. The recesses 412 have the same size and / or shape, or can help ensure that all fixtures 4 loaded in the system are aligned in the same way. Alignment of the fixture 4 may be important, for example, if the fixture 4 has an asymmetrical shape, eg, includes an inclined distal surface as shown in FIG. The recess 412 serves to reduce the contact area between the fixture 4 and the rotating body 3, thereby potentially reducing the friction that resists the sliding motion of the fixture 4 in the rotating body 3. FIG. 9 shows a top view of the fixture 4 together with the curved recess 412 and the side surface 411.

0022In another aspect of the invention, the fixture can have a through hole 44 extending through the body portion 43 and the head portion 41. The through hole 44 extends along the vertical axis of the body portion 43 and can provide a passage through the fixture 4, as seen in FIG. In one aspect of the invention, a portion of the through hole 44 can have a female threaded portion 441, for example, in the distal portion of the through hole 44 as shown in the cross-sectional view of the fixture of FIG. The proximal portion 442 of the through hole can have a diameter larger than the threaded portion 441, so for example the proximal portion 442 does not engage the mandrel 5. Proximal portion 442 can have any shape or size, for example can have smooth cylindrical holes. By arranging the through hole 44 such that only the distal portion of the fixture 4 engages the mandrel 5, the fixture 4 can be more easily disengaged from the mandrel 5 during deployment. However, the through hole 44 can be threaded over its entire length or threaded only at its proximal end. In this case, the mandrel 5 does not have to be threaded to the distal end, if desired. The pitch of the female thread portion 441 may be the same as, longer than, or shorter than the pitch of the male thread 42. In this exemplary embodiment, the thread pitch of the female thread portion 441 is shorter than the thread pitch of the male thread 42, for example to help disengage the fixture 4 from the mandrel 5 during deployment. That is, the longer thread pitch of the male screw 42 helps to pull the fixture 4 out of the mandrel 5 when pushing the fixture 4 into the material.

0023Fixtures shall be made of any suitable biocompatible material such as absorbent material (eg PLA), non-absorbable metal or plastic (eg titanium), or any other material or combination of materials. Can be done. Further, the fixture 4 has, for example, a length of about 1/4 inch (about 6.35 mm) and a diameter of about 1/8 inch (about 3.175 mm), and a penetrating inner diameter of about 1/32 inch (about 0.794 mm). It can be created in any suitable size such as.

0024The applier 100 can deploy the fixture 4 using a manually operated mechanism, an electric mechanism, or a combination of manual and electric. 11 and 12 show a left side view and a right side view of the manual operation mechanism of the applier 100 of FIG. 1, respectively. In this exemplary embodiment, the handle 1 includes a trigger 6 having two operable trigger levers 61 and 62 both swiveling around the trigger pivot 63. The external trigger lever 61 is exposed and gripped by the user, and the internal trigger lever 62 is housed in the external trigger lever 61. Both trigger levers 61 and 62 are pushed to the starting position shown in FIG. 11 by a spring 64 or other suitable elastic member. The external trigger lever 61 includes a mandrel drive rack 611 having teeth that engage the mandrel drive pinion 11. Therefore, when the external trigger lever 61 moves toward the handle 1, the mandrel drive rack 611 rotates the mandrel drive pinion 11 (counterclockwise as shown in FIG. 11). The mandrel drive cam 111 fixed to the pinion 11 now rotates and engages the pin 121 on the mandrel slider 12. When the external trigger lever 61 is in the starting position, the notch 112 of the mandrel drive cam 111 engages the pin 121, which causes the mandrel slider 12 to move proximally (on the right side of FIG. 11) by the bias of the spring 13. Can work. However, when the external trigger lever 61 is pressed and the mandrel drive cam 111 rotates, the cam 111 pushes the pin 121 distally, which causes the mandrel slider 12 to move distally against the urgency of the spring 13. Operate. Since the mandrel slider 12 is coupled to the mandrel 5, the mandrel 5 moves distally with the mandrel slider 12. The mandrel slider 12 only operates distally until the notch 112 disengages from the pin 121. After that, the mandrel slider 12 and the mandrel 5 remain stationary.

0025The internal trigger lever 62 remains stationary while the external trigger lever 61 is in initial operation from the starting position. However, when the external trigger lever 61 is further pressed, the external trigger lever 61 comes into contact with the internal trigger lever 62, so that the internal trigger lever 62 also rotates around the trigger pivot 63. The internal trigger lever 62 includes a rotating body drive rack 622 that engages a rotating body driving pinion 14 (see FIG. 12). Therefore, when the internal trigger lever 62 operates, the rotating body drive pinion 14 and the interlocking bevel gear 141 rotate, which are engaged with the complementary bevel gear of the clutch 15. As a result, when the rotating body drive pinion 14 rotates, the bevel gear 141 rotates the clutch 15 (for example, clockwise from the handle 1 looking down on the shaft 2). The clutch 15 engages with the rotating body 3, and therefore, when the clutch 15 rotates clockwise, the rotating body 3 also rotates clockwise. When the trigger levers 61 and 62 are continuously pressed, the rotating body 3 rotates, whereby the fixture 4 is deployed as described above. When the claw 16 is arranged to engage the mandrel drive rack 611 and thus the fixture begins to rotate (ie, when the external trigger 61 contacts the internal trigger 62 and the clutch 15 rotates the rotating body 3), The trigger levers 61 and 62 cannot return to the starting position shown in FIG. 11 until the trigger levers 61 and 62 are completely pressed. When the trigger levers 61 and 62 are completely pressed, the claw 16 is disengaged from the mandrel drive rack 611, whereby the mandrel drive rack 611 and the trigger levers 61 and 62 can be returned to the starting position. The return operation of the trigger levers 61 and 62 pushes the mandrel-driven pinion 11 and the rotating body-driven pinion 14 backward. As a result, the notch 112 returns to engagement with the pin 121 and thus the mandrel slide 12 and mandrel 5 can be moved proximally by the spring 13. While the trigger returns, the bevel gear 141 can rotate in the opposite direction, but the clutch 15 turns the rotating body 3 times. It is possible to prevent rolling. Instead, the rotating body 3 remains stationary during the return of the trigger.

0026Deployment of the most distal fixture 4 can be performed during the strokes of the trigger levers 61 and 62, i.e., before the trigger levers 61 and 62 are fully pressed and the claw 16 disengages from the mandrel drive rack 611. .. This arrangement can help ensure that the fixture 4 is disengaged from the mandrel 5 before the rotating body 3 stops rotating and the mandrel 5 retracts. For example, the fixture 4 can be arranged so as to disengage from the mandrel 5 when the rotating body 3 makes three rotations. However, the rotating body 3 can be arranged to rotate 3.5 times before stopping. After the rotating body 3 has stopped rotating, the claws 16 can be arranged so that the trigger levers 61 and 62 need to be further pressed for the claws 16 to disengage from the rack 611. During this operation of the trigger levers 61 and 62, other functions can be performed, such as activating a counter to indicate that the fixture has been deployed. In one embodiment, an indication of the deployed fixture and / or the remaining fixture can be provided to the handle 1 by, for example, an LCD or LED display.

0027Although some aspects of at least one embodiment of the present invention have been described, it should be understood that those skilled in the art will recall various changes, modifications and improvements. Such changes, modifications and improvements shall be part of this disclosure and shall fall within the spirit and scope of the present invention. Therefore, the above description and drawings are merely examples.

0028<figref num="1">It is a perspective view of the fixture applier according to the aspect of this invention.</figref><figref num="2">It is an end view of the distal end of the applier of FIG.</figref><figref num="3">FIG. 3 shows a cross-sectional view of the distal end of the applier at various stages of deploying the fixture.</figref><figref num="4">FIG. 3 shows a cross-sectional view of the distal end of the applier at various stages of deploying the fixture.</figref><figref num="5">FIG. 3 shows a cross-sectional view of the distal end of the applier at various stages of deploying the fixture.</figref><figref num="6">A side view of the fixture according to the aspect of the present invention is shown.</figref><figref num="7">The bottom perspective view of the fixture of FIG. 6 is shown.</figref><figref num="8">It is a top perspective view of the fixture of FIG.</figref><figref num="9">The top view of the fixture of FIG. 6 is shown.</figref><figref num="10">A cross-sectional view of the fixture of FIG. 6 is shown.</figref><figref num="11">It is the left side sectional view of the handle part of the fixture applyer.</figref><figref num="12">It is a right sectional view of the handle part of a fixture applyer.</figref>