JP2016537120A - Anchor with controlled driver orientation - Google Patents

Abstract

The present disclosure relates to an interference screw having a body with a proximal end, a distal end, and a longitudinal axis extending therebetween. The screw further includes a thread for securing the screw into the bone. The screw further includes a through bore defined by the body. The through bore extends between the proximal and distal ends along the longitudinal axis and has a surface. The screw further includes a control member (440) formed by the through-bore surface. To place the screw in the bone, the surgeon turns the screw with a screwdriver that engages the control member. The driver engages the control member only when in the drive orientation relative to the control member. Advantageously, with this “one-way” engagement, the surgeon can control and verify the orientation of the driver without looking at the driver and / or screw.

Description

  The present disclosure relates generally to medical devices and procedures, and more specifically to medical devices and procedures for reconstructing a ligament.

  In many cases, ligaments are damaged or ruptured as a result of an accident. Accordingly, various procedures have been developed to repair or replace such damaged ligaments.

  For example, in the case of a human knee, the anterior and posterior cruciate ligaments (ie, “ACL” and “PCL”) extend between the upper end of the tibia and the lower end of the femur. In many cases, the anterior cruciate ligament (i.e., ACL) is torn or damaged as a result of, for example, sports-related injuries. As a result, various surgical procedures have been developed that reconstruct ACLs to restore substantially normal function to the knee.

  In many instances, the ACL is reconstructed by replacing the torn ACL with a graft ligament. More specifically, in such procedures, generally a bone hole is formed in both the upper part of the tibia and the lower part of the femur, one end of the graft ligament is positioned in the femoral hole and the other end of the graft ligament is in the tibial hole. Positioned within, the intermediate portion of the graft ligament spans the distance between the lower femur and the upper tibia. The two ends of the graft ligament should be aligned so that the graft ligament extends between the lower end of the femur and the upper end of the tibia in substantially the same way as the original ACL and has substantially the same function. It is fixed in each bone hole by various techniques well known to those skilled in the art. Thereby, this graft ligament cooperates with the surrounding anatomy to restore substantially normal function to the knee.

  In some examples, the graft ligament is a ligament or tendon taken from anywhere within the patient's body, for example, a patella tendon with or without a bone block attached, a semi-tendon-like tendon, and / or a thin muscle It can be a tendon.

  As described above, various strategies are known in the art to secure the two ends of the graft ligament within the femoral and tibia bone holes.

  In one known procedure that may be applied to femoral fixation, tibia fixation, or both, the end of the graft ligament is placed in the bone hole, and the graft ligament is then generally “interfering” in the art. Secure in place using orthopedic headless screws, known as screws. More specifically, this strategy is used to place the end of the graft ligament into the bone hole and then advance the interference screw into the bone hole so that the interference screw extends parallel to the bone hole. And simultaneously engage both the graft ligament and the bone hole sidewall. In this arrangement, the interference screw essentially drives the graft ligament laterally to engage the opposite side wall of the bone hole, thereby securing the graft ligament to the bone using a so-called “interference fit”. Fix it. Thereafter, over time (eg, months), the graft ligament and the host bone grow together at their contacts, resulting in a strong natural joint between the ligament and the bone.

  Interference screws have proven to be an effective means to secure the graft ligament in the bone hole in many applications such as ACL reconstruction and biceps tendon fixation. However, since interference screws typically occupy a significant amount of space within the bone hole, the surface area contact between the graft ligament and the side wall of the bone hole may be limited. This in turn limits bone-ligament ingrowth and can consequently affect the strength of the joint. By way of example, but not limitation, it is estimated that common interference screws obstruct approximately 50% of potential bone-ligament integration regions.

  For this reason, interference screws made from resorbable materials, where the interference screw can eventually disappear over time and bone-ligament ingrowth can occur around the entire circumference of the bone hole Considerable efforts have been made to provide To this end, a variety of absorbable interference screws have been developed made from biocompatible and bioabsorbable polymers such as polylactic acid (PLA), polyglycolic acid (PGA), and the like. These polymers generally do not advance the interference screw into place and then hold the graft ligament in place during bone-ligament ingrowth, rather than staying in place permanently. To provide the considerable mechanical strength required.

  In general, interference screws made from such biocompatible and bioabsorbable polymers have proven clinically advantageous. However, these absorptive interference screws still have some disadvantages. First, clinical evidence suggests that the quality of bone-ligament ingrowth is that natural bio-absorbable polymers tend to replace fibrous masses rather than aligned tissue matrices. It suggests that it is somewhat different from ligament ingrowth. Secondly, clinical evidence suggests that absorption generally takes a considerable period of time, for example on the order of 3 years. Thus, during this resorption time, bone-ligament ingrowth remains significantly limited by the presence of interfering screws. Third, clinical evidence suggests that for many patients, absorption is never complete and a significant amount of relics remains in the body. The problem is that absorbent interference screws generally tend to be quite large to provide adequate strength, for example, interference screws have a diameter (i.e., outer diameter) of 8-12 mm and a length of 20-25 mm. Some emphasis is placed on the fact that it is general.

US Patent Application Publication No. 20080154314

  Thus, (i) new and improved, having the necessary strength to hold the graft ligament in place while bone-ligament ingrowth occurs, and (ii) promoting superior bone-ligament ingrowth An interference fixation system is needed.

  In one aspect, the present disclosure relates to an interference screw. The screw includes a body having a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The screw further includes a thread extending in an open helical form between the proximal and distal ends of the body. The screw further includes a through bore defined by the body extending between a proximal end and a distal end of the body along a longitudinal axis. The through bore has a surface on which the control member is formed. The control member is engaged by the driver when the driver is in a driving orientation with respect to the control member. The control member is not engaged by the driver when the driver is in an orientation different from the drive orientation.

  In another aspect, the present disclosure is directed to a method of placing an interference screw in bone. The method includes removing the driver from the body of the interference screw inserted into the bone. The body has a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. The body defines a through bore extending between the proximal and distal ends along the longitudinal axis. The through bore has a surface. The method further includes engaging a control member formed by the surface of the through bore with the driver. The control member is engaged by the driver when the driver is in a driving orientation with respect to the control member. The control member is not engaged by the driver when the driver is in an orientation different from the drive orientation. The method further includes confirming the orientation of the driver within the body of the screw based on the engagement of the control member and the driver.

  In yet another aspect, the present disclosure is directed to another method of placing an interference screw in a bone. The method first includes inserting a driver into a through bore defined by a body of screws inserted into the bone. The through bore extends between the proximal and distal ends of the body along a longitudinal axis that extends between the proximal and distal ends of the body. The through bore has a surface. The method further includes rotating the driver within the through bore about the longitudinal axis of the body until the driver engages a control member formed by the surface of the through bore. Engagement confirms the driver's drive orientation relative to the control member. The method further includes further driving the screw into the bone with the driver in a driving orientation.

  Further scope of the applicability of the present disclosure will become apparent from the detailed description provided below. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

  The accompanying drawings, which are incorporated in and form a part of this specification, illustrate the embodiments of the present disclosure and, together with the written description, serve to explain the principles, characteristics, and features of the present disclosure.

1 is a diagram illustrating a first embodiment of a delivery device of the present disclosure. FIG. FIG. 2 is a side view showing a shaft of the delivery device of FIG. FIG. 3 is an exploded view showing a distal end of the shaft body of FIG. FIG. 3 is a cross-sectional view showing the shaft body of FIG. FIG. 3 is a front view showing a distal end of the shaft body of FIG. FIG. 3 is an isometric view showing a screw used with the shaft of FIG. FIG. 6 is a side view showing the screw of FIG. FIG. 7 is a cross-sectional view showing the screw of FIG. FIG. 6 is a diagram illustrating a second embodiment of the shaft body of the present disclosure. FIG. 9 is a side view showing an inner member of the shaft body of FIG. FIG. 10 is an exploded view showing the distal end of the inner member of FIG. FIG. 10 is a cross-sectional view showing an inner member of the shaft body of FIG. FIG. 10 is a front view showing a distal end of the inner member of FIG. FIG. 9 is an isometric view showing an outer member of the shaft body of FIG. FIG. 13 is a cross-sectional view showing the outer member of FIG. FIG. 9 is a side view showing the shaft body of FIG. FIG. 15 is a side view showing the shaft body of FIG. 8 in which the outer member is at a position different from that of FIG. FIG. 6 is an isometric view illustrating a third embodiment of a shaft body and a screw used with the shaft body of the present disclosure. FIG. 17 is an isometric view showing the shaft of FIG. FIG. 17 is an isometric view showing the screw of FIG. FIG. 17 is a side view showing the screw of FIG. FIG. 20 is a cross-sectional view showing the screw of FIG. FIG. 6 is an isometric view showing a shaft according to a fourth embodiment of the present disclosure and a screw used with the shaft. FIG. 22 is an isometric view showing the screw of FIG. FIG. 22 is an isometric view showing the shaft of FIG. FIG. 22 is an isometric view showing the shaft of FIG. 21 and an alternative screw used with the shaft. FIG. 25 is a side view showing the screw of FIG. 24. FIG. 25 is a cross-sectional view showing the screw of FIG. 24. It is a side view which shows the interference screw by which the full length is supported by the driver. It is a side view which shows the interference screw by which the full length is not supported by the driver. It is a side view which shows the interference screw which is structurally broken. It is a figure which shows an example of the interference screw in which the control member is further inserted in the bone. It is a figure which shows an example of the interference screw in which the control member is further inserted in the bone. It is a figure which shows an example of the interference screw in which the control member is further inserted in the bone. It is a side view which shows an example of the interference screw provided with the control member. It is an end view which shows an example of the interference screw provided with the control member. 4 is a top view showing a cross section of a driver in a driving orientation with respect to an interference screw. FIG. 33B is a top view showing a cross section of a driver in an orientation different from the drive orientation of FIG. 33A. It is a figure which shows the example of a control member. It is a figure which shows the example of a control member.

  The following description of the preferred embodiments is merely exemplary in nature and is not intended to limit the disclosure, its application, or use in any way.

  FIG. 1 shows a first embodiment of a delivery device 10 of the present disclosure. Device 10 includes a handle assembly 11 and a shaft 12 coupled to handle assembly 11. The handle assembly 11 includes a handle 11a and a connector 11b connected to the handle 11a. The connector 11b has a channel 11b ′ and an opening 11b ″ to the channel 11b ′. The opening 11b ″ has a “D” shape. The proximal end 12a of the shaft 12 is disposed in the channel 11b ′.

  2, 2 </ b> A, and FIGS. 3 to 4 show the shaft body 12. The shaft 12 includes a proximal end 12a and a distal end 12b. The proximal end 12a is “D” shaped to match the shape of the opening 11b ″. The distal end 12b includes a thread 12c, a groove 12d, and a depth stop 12e. The groove 12d extends a partial length of the shaft body 12 and intersects the screw thread 12c. The depth stop 12e is used with a depth stop on the screw, and the device 10 is used to embed in the bone hole during ligament reconstruction.

  5-7 illustrate a screw 20 used with the delivery device 10 of the present disclosure. Screw 20 includes a proximal end 21 and a distal end 22. Most of the screws 20 extend from the proximal end 21 to the distal end 22 in the form of an open spiral coil, i.e., in a spiral or spiral form, and the space between the coil turns defines the aperture 24. A thread 23 in the form of a connected series of consecutive regular spaced turns. In other words, the interference screw 20 may include an open spiral coil that defines an internal volume, the internal volume being in communication with a region outside the open spiral coil through an interval between turns of the open spiral coil. . The distal end 22 also includes a depth stop 25 that extends a partial length of the screw 20. The depth stop 25 includes a proximal end 25a and a distal end 25b. In addition, a plurality of longitudinally extending runners 26 extend along the interior of the thread 23.

  The distal end 12b of the shaft body 12 is inserted into the screw 20 through the opening 27 until the proximal end 25a of the depth stop 25 engages the depth stop 12e of the shaft body 12. While inserting the shaft body 12 into the screw 20, the runner 26 engages the groove 12d and is received in the groove 12d. As shown in FIG. 1, the distal end 12b of the shaft 12 also includes hash marks 12f, each associated with a number 12g. When the screw 20 is placed on the shaft 12, the proximal end 21 of the screw 20 is aligned with one of the hash marks / numbers 12f, thereby indicating the length of the screw 20.

  8, 9-9A, and 10-15 illustrate an alternative shaft 30 of the present disclosure. The shaft body 30 includes an inner member 31 and an outer member 32 disposed on the inner member 31. The proximal end 31 a of the inner member 31 has the same shape as the proximal end 12 a of the shaft body 12. The distal end 31b of the inner member 31 includes a thread 31c. The groove 31d extends along the member 31 and intersects the thread 31c. In addition, a thread 31e is disposed between the proximal end 31a and the distal end 31b of the member 31. The outer member 32 includes a first compartment 32a and a second compartment 32b. The first section 32a has a larger diameter than the second section 32b. The first section 32a also includes a thread 32c on the inner wall 32d of the outer member 32.

  When the outer member 32 is disposed on the inner member 31, the thread 32c engages the thread 31e to move the outer member 32 relative to the inner member 31. By moving the outer member 32 relative to the inner member 31, the distal end 31b of the inner member 31 becomes somewhat visible. Similar to the distal end 12b of the shaft 12, the distal end 31b of the inner member 31 includes a hash mark / number (not shown) that aligns with the end 32b 'of the second compartment 32b, thereby allowing the inner The length of the screw 40 disposed on the distal end 31b of the member 31 is shown. As shown in FIGS. 14 and 15, the outer member 32 is positioned at different positions along the length of the inner member 31 to load screws 40 of different lengths on the distal end 31b of the inner member 31. It becomes possible to do.

  A handle assembly similar to the handle assembly 11 is coupled to the proximal end 31 a of the inner member 31. Similar to screw 20, screw 40 includes a proximal end 41 and a distal end 42. The screw 40 includes a thread 43 in the form of an open spiral coil having an interior and a plurality of longitudinally extending runners 45 extending along the interior of the thread 43. Screw 40 is more fully described in US Patent Publication No. 20080154314, the entire disclosure of which is incorporated herein by reference. As the outer member 32 moves to indicate the screw length, the screw 40 is loaded onto the distal end 31b so that the proximal end 41 of the screw 40 engages the end 32b 'and the runner 45 is The groove 31d is engaged and received in the groove 31d.

  16-20 illustrate another alternative embodiment of the shaft 50 and screw 60 of the present disclosure. Shaft body 50 includes a first portion 51 including a proximal end 51a and a distal end 51b, and a second portion 52 including a first range 52a and a second range 52b. Proximal end 51 a is configured to be coupled to a handle assembly similar to handle assembly 11. However, other handle assemblies may be used. Since the first range 52a has a smaller diameter than the first portion 51, a first depth stop 51b ′ is present at the distal end 51b of the first portion 51. Since the second range 52b has a smaller diameter than the first range 52a, the second depth stop 52c exists between the first range 52a and the second range 52b. The end 52b 'of the second region 52b is tapered to facilitate insertion of the anchor 60 into the bone during ligament reconstruction, as described in more detail below. The second portion 52 also includes a groove 53 that extends between the first range 52a and the second range 52b. There are three grooves 53 for purposes of this disclosure. However, the second portion 52 may include more or fewer grooves 53.

  Similar to the screw 20 shown in FIGS. 5-7, the screw 60 includes a proximal end 61 and a distal end 62. Most of the screw 60 extends from the proximal end 61 to the distal end 62 in the form of an open spiral coil, i.e., in a spiral or spiral form, and the space between the turns of the coil defines the aperture 64. A thread 63 in the form of a connected series of consecutive regular spacing turns. In other words, the interference screw 60 may include an open spiral coil that defines an internal volume, the internal volume being in communication with a region outside the open spiral coil through an interval between turns of the open spiral coil. . The distal end 62 also includes a depth stop 65 that extends the partial length of the screw 60. The depth stop 65 includes a proximal end 65a and a distal end 65b. Unlike the open depth stop 25 of the screw 20 shown most clearly in FIG. 5, the depth stop 65 of the screw 60 is a closed depth stop shown most clearly in FIG. In addition, a plurality of longitudinally extending runners 66 extend along the interior of the thread 63.

  The second portion 52 of the shaft body 50 is inserted into the screw 60 through the opening 67 until the proximal end 65a of the depth stop 65 engages the second depth stop 52c of the shaft body 50. Can be put. While inserting the shaft body 50 into the screw 60, the runner 66 engages the groove 53 and is received in the groove 53. The screw 60 may be of various lengths. For example, the screw 60 may be of a length such that its proximal end 61 engages the first depth stop 51b ′.

  As described above, during ligament reconstruction, the end of the graft ligament is placed in the bony hole and then the interference screw 20, 40, 60 is inserted into the bony hole by using the shaft 12, 30, 50. Advanced so that the interference screws 20, 40, 60 extend parallel to the bone hole and simultaneously engage both the graft ligament and the side wall of the bone hole. The screws 20, 40, 60 may be used in either the femoral hole or the tibial hole. The method of ligament reconstruction using screws 20, 40, 60 is further described in the above-mentioned publication 314.

  21-23 illustrate yet another alternative embodiment of the screw 100 and delivery device 200 of the present disclosure. The screw 100 includes a proximal end 101 and a distal end 102. Most of the screw 100 extends from the proximal end 101 to the distal end 102 in the form of an open spiral coil, i.e., in a spiral or spiral form, and an aperture 104 is defined by the space between the turns of the coil. A thread 103 in the form of a connected series of consecutive regular spaced turns. In other words, the interference screw 100 may include an open spiral coil that defines an internal volume, the internal volume being in communication with a region outside the open spiral coil through an interval between turns of the open spiral coil. . The distal end 102 also includes a suture bridge 105 that extends a partial length of the screw 100. The suture bridge 105 includes a proximal end 105a and a distal end 105b. The distal end 105b includes a concave shape. A flexible member, such as suture 110, is received within screw 100 such that suture 110 extends around distal end 105b of bridge 105. In addition, a longitudinally extending runner 106 extends from the suture bridge 105 along the interior of the thread 103. For the purposes of this disclosure, there are two longitudinally extending runners 106. However, more or fewer than two runners are within the scope of this disclosure.

  Delivery device 200 includes a distal end 201 having a slot 202 and a groove 203 extending from slot 202 on both sides of device 200. As shown in FIG. 21, the screw 100 is disposed at the distal end 201 such that the suture bridge 105 is received in the slot 202 and the runner 106 is received in the groove 203. Since delivery device 200 is intubated, suture end 110a, 110b extends through cannulation 204 when screw 100 is placed over device 200.

  24-26 show a screw 300 similar to the screw 100. However, the screw 300 further includes a pointed tip 311 disposed at the distal end 302. The tip 311 includes a through hole 312. The hole 312 helps to place the suture 110 within the screw 300. As shown in FIG. 24, the screw 300 is disposed at the distal end 201 of the delivery device 200 such that the suture bridge 305 is received in the slot 202 and the runner 306 is received in the groove 203. . As described above, since delivery device 200 is intubated, when screw 300 is placed over device 200, suture ends 110a, 110b extend through intubation 204 as shown in FIG.

  For clarity purposes, only the distal end 201 of the device 200 is shown. However, the device 200 includes a proximal end that may be coupled to a handle assembly similar to the handle assembly 11 described above, similar to the device described above. The screws 100, 300 are used for soft tissue repair, specifically to reattach the tissue to the bone. An example of this repair is the use of the device 200 to deliver the screws 100, 300 into the bone, the device 200 removed from the screws 100, 300, and the tissue on the bone so that it is adjacent to the screws 100, 300. In this case, the suture ends 110a, 110b are pulled through the tissue and then the suture ends 110a, 110b are tied. Holes may be made in the bone prior to inserting the screws 100, 300 into the bone. However, the screw 300 may be inserted into the bone without first making a hole in the bone. In this case, the sharp tip 311 may be used to initiate insertion of the screw 300 into the bone, and then a rotational motion may be used to complete the insertion of the screw 300 into the bone. Other methods of tissue repair by using these screws and delivery devices may also be used.

  The handle 11a of the handle assembly 11 is made of plastic, but other non-metallic and metallic materials may also be used. The shape and size of the handle 11a may be any shape and size necessary to help facilitate the insertion of the screw 20 into the bone. The coupler 11b is made from a metallic material such as stainless steel or titanium, but may be made from other metallic and non-metallic materials that are strong enough to withstand the forces applied during surgery. The coupler 11b is press fitted to the handle 11a, but may be coupled to the handle 11a in any other manner known to those skilled in the art. The size and shape of the coupler 11b may be any size and shape necessary to help facilitate the insertion of the screw 20 into the bone. The channel 11b ′ may be of any length necessary to facilitate the coupling of the shaft body 12 to the coupler 11b, and the opening 11b ″ is of any shape required for that purpose. May be.

  The shaft 12 is made from a metallic material such as stainless steel or titanium, but other metallic and non-metallic materials that can withstand the forces applied during the procedure may be used. The diameter of the shaft body 12 may vary. The proximal end 12a of the shaft 12 may be any shape necessary to facilitate the insertion of the end 12a into the channel 11b ′ through the opening 11b ″. The number of threads 12c and grooves 12d may vary, and the length of grooves 12d may also vary. The position of the depth stop 12e may also vary based on the diameter of the shaft 12 and the diameter of the screw 20 used. Groove 12d, depth stop 12e, and thread 12c may be formed by any method known to those skilled in the art.

  The screw 20 is made from a polymer material by a molding method. However, other materials that allow the screw 20 to withstand the forces applied during the procedure and other methods of making may be used. The depth stop 25 is an open end type and does not extend over the entire inner diameter of the screw 20. The amount of the inner diameter of the screw spanned by the depth stop 25 may vary, and the length of the depth stop 25 may vary based on the diameter of the screw. The number and length of runners 26 may also vary. When the screw 20 is disposed on the shaft 12, the distal end 12 b of the shaft 12 extends from the distal end 22 of the screw 20. While inserting the screw 20 into the bone, the thread 12c creates a thread in the bone, thereby creating a seat for the thread 23, as fully described in the '314 publication. The amount that the distal end 12b of the shaft 12 extends from the distal end 22 of the screw 20 may vary.

  The diameter of the first and second sections 32a, 32b of the outer member 32 may vary, and the number of threads 32c may vary. The number of the threads 31c and 31e and the groove 31d may vary, and the length of the groove 31d may also vary. The inner and outer members 31, 32 are made from metallic materials such as stainless steel and titanium by methods known to those skilled in the art. However, other materials may be used. The screw 40 is made from a polymer material by a molding method. However, other materials and production methods may be used. The number and length of runners 45 may also vary. When the screw 40 is disposed on the shaft 30, the distal end 31 b of the shaft 30 extends from the distal end 42 of the screw 40. While inserting the screw 40 into the bone, the thread 31c creates a thread in the bone, thereby creating a seat for the thread 43, as fully described in the '314 publication. The amount that the distal end 31b of the shaft 30 extends from the screw 40 may vary.

  The shaft 50 is made from a metallic material such as stainless steel or titanium, but may be made from another metallic or non-metallic material that is strong enough to withstand the forces applied to the shaft 50 during surgery. . The shaft 50 may be made by methods known to those skilled in the art. The diameter of the first and second portions 51, 52 may vary with the number and length of the grooves 53, and the position of the depth stops 52c, 51b 'depends on the diameter of the screw 60 or other factors May vary. Instead of being tapered, the end 52b 'may be designed in another manner that allows for easier insertion of the screw 60 into the bone. The screw 60 is made from a polymer material by a molding method. However, other materials that allow the screw to withstand the forces applied during surgery and other methods of making may be used. The number and length of runners 66 may also vary. When the screw 60 is disposed on the shaft 50, the second portion 52 of the shaft 50 extends from the distal end 62 of the screw 60. The amount that the second portion 52 extends from the screw 60 may vary. In addition, the length of the depth stop 65 may vary based on the diameter of the screw 60 or other factors.

  The delivery device 200 is made from a metallic material such as stainless steel or titanium, but may be made from a non-metallic material that is strong enough to withstand the forces applied to the device 200 during surgery. The delivery device 200 is made by methods known to those skilled in the art. The screws 100, 300 are made from a polymeric material by a molding process, but other materials that allow the screws to withstand the forces applied during surgery and other processes known to those skilled in the art are used. Also good. The suture bridge 105 may have a distal end 105b having a shape other than concave, and the length of the suture bridge 105, slot 202, and groove 203 may vary. The size and shape of the hole 312 may vary.

  In order to properly insert the screw into the bone using several interference screw designs, it is necessary to support the full length of the screw (or a substantial portion thereof) by a driver as shown in FIG. . The need is particularly great when the screw is made from a weak and / or brittle material, such as an osteoconductive material. This is also common when the screw has a fenestration or opening that reduces the bending (torsion) strength of the screw. As shown in FIG. 28, inserting a screw into the bone when not fully supported may result in screw failure as shown in FIG. With several screw designs, the orientation of the driver with respect to the screw determines whether the screw is fully supported. Therefore, in these designs, it is necessary to control the orientation of the driver with respect to the screw.

  It may be impossible or difficult for the surgeon to visually observe the screw and / or driver to confirm the orientation of the driver relative to the screw. For example, the surgeon's field of view may be disturbed when the screw is partially loaded into the bone. Therefore, there is a further need to visually confirm the orientation of the driver with respect to the screw.

  30A-30C show an example of a screw 400 with a control member in bone 401 being driven by a surgeon. As shown, the screw 400 is located on the surface of the bone 401. The surgeon inserts the driver 450 into the screw 400 to drive the screw 400 further into the bone 401 to be flush with the bone surface. The surgeon then rotates the driver 450 within the screw 400 until the control member of the screw 400 is engaged. Engagement of the driver 450 with the control member confirms that the driver 450 is in the proper “drive” orientation, and the surgeon is confident that the screw 400 is fully supported by the driver 450. The surgeon can then drive the screw 400 into the bone 401 without worrying about the screw 400 breaking.

  FIG. 31 shows an example of a screw 400 having a body 405. Body 405 includes a proximal end 410, a distal end 415, and a longitudinal axis 420 extending between the proximal and distal ends 410, 415. The body 405 may be made from bioabsorbable, non-bioabsorbable, osteoconductive, or composite materials. Examples of non-bioabsorbable materials include polyetheretherketone (PEEK), titanium, and surgical stainless steel. The screw 400 further includes a thread 425 that extends in an open spiral configuration between the proximal end 410 and the distal end 415 of the body 405. In some examples of screw 400, thread 425 is similar to thread 63 described above with reference to FIGS.

  FIG. 32 shows a body 405 that defines a through bore 430. The through bore 430 extends along the longitudinal axis 420 between the proximal and distal ends 410, 415 of the body. The through bore 430 has a surface 435. The screw 400 includes a control member 440 formed by a through bore surface 435. Driver 450 engages control member 440 when driver 450 is in a driving orientation with respect to screw 400. Driver 450 does not engage control member 440 when driver 450 is in a different orientation than the drive orientation.

  The example control member 440 shown in FIG. 32 includes a plurality of runners 445 that extend between the proximal and distal ends 410, 415 of the body 405 along the longitudinal axis 420. Although three runners (445a, 445b, 445c) are shown, other multiple (eg, two and four) runners are possible. The plurality of runners 445 are evenly spaced around the circumference of the through bore 430. There is an equal distance (d) between each runner (445a, 445b, 445c) (distance (d) is measured from the center line to the center line of each runner, for example). The runners (445a, 445b, 445c) can be described as being arranged radially about the longitudinal axis 420 (which emerges from the page of the drawing). Therefore, it can be explained that the positions of the runners (445a, 445b, 445c) are 0 ° (12 o'clock), 120 ° (4 o'clock), and 240 ° (8 o'clock), respectively.

  One of the plurality of runners is of a different shape and / or size than the other runners. A convenient example of the control member 440 includes one runner (445a) having a cross-sectional shape based on a rectangle and other runners (445b, 445c) having a cross-sectional shape based on a semicircle. Other cross-sectional shapes are possible. In another example of the control member 440, the dimensions, such as width and / or height, of one or more runners (445a, 445b, 445c) vary with the overall size of the screw 400. For example, the first anchor is larger in size than the second anchor. In the first anchor, the runner height is higher than the runner height associated with the second anchor.

  Next, FIG. 33A to FIG. 33B, which is a cross-sectional view of the driver 450, viewed from above. The driver 450 used by the surgeon to screw the screw 400 into the bone 401 includes a groove 455. The groove 455 has a geometric shape obtained by reversing the plurality of runners 445. When the driver 450 is in the drive orientation shown in FIG. 33A, the corresponding driver groove 455 accommodates a plurality of runners 445 so that the surgeon can use the driver 450 to turn the screw 400. When the driver 450 is not in the driving orientation as shown in FIG. 33B, the corresponding driver groove 455 does not accommodate multiple runners 445 (represented by hidden lines in the figure) and the surgeon uses the screwdriver 450 to screw Can't turn 400. In the example shown in FIG. 33B, the driver groove 455 accommodates multiple runners 445 so that the driver rotates counterclockwise (in the direction of the arrow shown) from the 10 o'clock position to the 9 o'clock position. Is done.

  The arrangement described above results in a “one-way” engagement, because the surgeon can control and verify the orientation of the driver 450 without looking at the driver 450 and / or the screw 400, i.e., the treatment without the eye. Is advantageous. If the surgeon can insert the driver 450 into the screw 400 and rotate freely (i.e., without resistance), or cannot insert the driver 450 into the screw 400 at all, the surgeon will place the driver 450 in the drive orientation. I understand that there is no. The surgeon can then rotate the driver 450 until the control member 440 of the screw 400 is engaged. Engaging the control member 440 drives the screw 400 into the bone, resulting in the surgeon having to turn the driver 450 more strongly. Thus, advantageously, some examples of screw 400 provide tactile feedback that allows the surgeon to look for an appropriate drive orientation.

  FIG. 34A shows another example of a control member 440 that includes a plurality of runners 445 ′ that extend between the proximal and distal ends 410, 415 of the body 405 along the longitudinal axis 420. The plurality of runners 445 ′ are unevenly spaced around the circumference of the through bore 430. There is a different distance (d, d ', d' ') between each runner 445' (distance (d, d ', d' ') is measured, for example, from the centerline to the centerline of each runner. ). In terms of the radial arrangement, the position of the runner 445 ′ is a position where the frequency separating the positions is not uniform.

  FIG. 34B shows yet another example of a control member 440 that includes a plurality of runners 445 ″ extending between the proximal and distal ends 410, 415 of the body 405 along the longitudinal axis 420. The plurality of runners 445 ″ are evenly spaced around the circumference of the through bore 430. The exemplary control member 440 further includes a tab 460 spaced between a pair of adjacent runners (445a ″ and 445b ″). Another example of the control member 440 includes a plurality of runners that are unevenly spaced about the circumference of the through bore and includes tabs spaced between adjacent pairs of runners. In some examples, tab 460 extends a portion of the length of screw 400 and is different from the runner. Although one-way or “keyed” features of the screw 400 have been described with reference to the example arrangements described above, those skilled in the art will readily recognize that other arrangements are possible.

  Other examples of screws 400 include depth stops such as the open depth stop 25 described above with reference to FIG. 5 and the closed depth stop 65 described above with reference to FIG. The depth stop engages the depth stop of driver 450 such that the distal end of the driver extends beyond the distal end of the body. In yet another example of the screw 400, the proximal end 410 of the body 405 aligns with a hash mark on the distal end of the driver, and the number associated with the hash mark reduces the length of the body 405 of the screw 400. Identify.

  In one example procedure of installing the screw 400 in the bone 401, the surgeon may remove the driver 450 from the body 405 of the screw 400 that is partially inserted into the bone 401. The surgeon reinserts the driver 450 into the body 405 of the screw 400 and engages the control member 440. The surgeon confirms the orientation of the driver 450 based on the engagement of the control member 440 and the driver 450. By engagement of the control member 440, the surgeon knows that the driver 450 is in the drive orientation. Without engagement, the surgeon knows that the driver 450 is in a different orientation than the drive orientation. If the driver 450 does not engage the control member 440 (eg, the surgeon turns the driver 450 but the screw 400 does not turn), the surgeon will engage the control member 440 (eg, the surgeon may The screwdriver 450 is rotated in the through bore 430 until the screw is turned.

  In the example procedure, each time the surgeon removes the driver 450 and reinserts it into the screw, the surgeon uses the control member 440 to control and verify the orientation of the driver 450. This is advantageous because the surgeon may have to remove and re-insert the driver 450 multiple times during the procedure in order for the screw 400 to be fully installed in the bone 401.

  Some examples of the screw 400 may be part of a screwing system that includes the driver 450 described above. In one example system, the screw 400 may be “preloaded” and disposed at the distal end of the driver 450.

  Since the exemplary embodiments can be variously modified without departing from the scope of the present disclosure as described above with reference to the corresponding examples, all matters contained in the above description and shown in the accompanying drawings are To be interpreted as illustrative rather than limiting. Accordingly, the breadth and scope of the present disclosure is not limited by any of the above-described exemplary embodiments, but is defined only in accordance with the following claims appended hereto and their equivalents. Shall.

10 Delivery device
11 Handle assembly
11a handle
11b connector
11b 'channel
11b '' opening
12 shaft
12a proximal end
12b distal end
12c thread
12d groove
12e Depth stop
12f hash mark
12g numbers
20 screws
21 Proximal end
22 Distal end
23 Thread
24 Aperture
25 Depth stop
25a proximal end
25b distal end
26 Lanna
27 opening
30 shaft
31 Inner member
31a proximal end
31b distal end
31c thread
31d groove
31e thread
32 Outer member
32a first compartment
32b 2nd partition
32b 'end
32c thread
32d inner wall
40 screws
41 Proximal end
42 Distal end
43 Thread
45 Lanna
50 shaft body
51 First part
51a proximal end
51b distal end
51b 'first depth stop
52 Second part
52a First range
52b Second range
52b 'end
52c 2nd depth stop
53 Groove
60 screws
61 Proximal end
62 Distal end
63 Thread
64 aperture
65 Depth stop
65a proximal end
65b distal end
66 Lanna
67 opening
100 screws
101 proximal end
102 Distal end
103 thread
104 Aperture
105 suture bridge
105a proximal end
105b distal end
106 Lanna
110 suture
110a suture end
110b suture end
200 delivery devices
201 Distal end
202 slots
203 groove
204 Intubation
300 screws
302 Distal end
305 suture bridge
306 Lanna
311 Tip
312 Through hole
400 screws
401 bones
405 body
410 proximal end
415 Distal end
420 Longitudinal axis
430 Through bore
435 surface
440 Control member
445a, 445b, 445c runners
445a ', 445b', 445c 'runner
445a '', 445b '', 445c '' runner
450 drivers
455a, 455b, 455c groove
460 tab

Claims (25)

A body having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end;
A thread extending in an open spiral configuration between the proximal end and the distal end of the body;
A through bore defined by the body extending between the proximal end and the distal end of the body along the longitudinal axis and having a surface;
A control member formed by the surface of the through bore, wherein the driver is engaged by the driver when in a driving orientation relative to the control member, and the driver is in an orientation different from the driving orientation A control member not engaged by the driver.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, wherein the plurality of runners are even around the circumference of the through bore The interference screw according to claim 1, wherein one of the plurality of runners is of a different shape and / or size than the other runners.   3. The interference screw according to claim 2, wherein the one runner has a cross-sectional shape based on a rectangle, and the other runner has a cross-sectional shape based on a semicircle.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, the plurality of runners being non-circular around the circumference of the through bore. The interference screw of claim 1, which is evenly spaced.   5. The interference screw according to claim 4, wherein one of the plurality of runners has a cross-sectional shape based on a rectangle, and the other runner has a cross-sectional shape based on a semicircle. The control member is
A plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, the runners being evenly spaced around the circumference of the through bore; ,
2. The interference screw according to claim 1, comprising a tab spaced between a pair of adjacent runners. The control member is
A plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, the runners being unevenly spaced about the circumference of the through bore When,
2. The interference screw according to claim 1, comprising a tab spaced between a pair of adjacent runners.   The interference screw of claim 1, wherein the body is made from a bioabsorbable material, a non-bioabsorbable material, an osteoconductive material, or a composite material.   The interference screw of claim 8, wherein the non-bioabsorbable material comprises polyetheretherketone (PEEK), titanium, and surgical stainless steel.   The interference screw of claim 1, wherein the body is made from a non-bioabsorbable material and the thread is made from a bioabsorbable material.   The interference screw of claim 1, wherein the through bore is adapted to receive an ingrowth core.   The interference screw according to claim 11, wherein a bone growth factor is added to the ingrowth core so as to enhance bone ingrowth.   Further comprising a depth stop extending longitudinally a partial length of the body, the depth stop extending so that the distal end of the driver extends beyond the distal end of the body. The interference screw of claim 1, wherein the interference screw engages a depth stop.   14. The interference screw of claim 13, wherein the depth stop is an open depth stop that surrounds a portion of the distal end within the body.   14. An interference screw according to claim 13, wherein the depth stop is a closed depth stop surrounding the distal end of the body.   2. The proximal end of the body is aligned with a hash mark on the distal end of the driver, and a number associated with the hash mark identifies the length of the body of the interference screw. Interference screw. Removing the driver from the body of the interference screw inserted into the bone, wherein the body has a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The body defining a through bore extending between the proximal end and the distal end along the longitudinal axis, the through bore having a surface;
Engaging a control member formed by the surface of the through bore with the driver, wherein the control member is engaged by the driver when the driver is in a driving orientation with respect to the control member. Not being engaged by the driver when the driver is in an orientation different from the drive orientation;
Confirming the orientation of the driver within the body of the interference screw based on engagement of the control member and the driver.   18. The method of claim 17, further comprising rotating the driver relative to the control member within the through-bore about the longitudinal axis of the body until the driver engages the control member. The method described.   Until the distal end of the driver extends beyond the distal end of the body, the depth stop of the driver engages a depth stop extending longitudinally a partial length of the body. The method of claim 17, further comprising inserting the driver into the through bore.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, wherein the plurality of runners are even around the circumference of the through bore The method of claim 17, wherein one of the plurality of runners is of a different shape and / or size than the other runners.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, the plurality of runners being non-circular around the circumference of the through bore. 18. A method according to claim 17, wherein the methods are evenly spaced. First, inserting a driver into a through bore defined by a body of an interference screw inserted into the bone, wherein the through bore extends between a proximal end and a distal end of the body. Extending along the directional axis between the proximal end and the distal end of the body, the through-bore having a surface;
Rotating the driver within the through-bore about the longitudinal axis of the body until the driver engages a control member formed by the surface of the through-bore, the engagement Confirming the driving orientation of the driver with respect to the control member, and
Further driving the interference screw into the bone while the driver is in the drive orientation.   Until the distal end of the driver extends beyond the distal end of the body, the depth stop of the driver engages a depth stop extending longitudinally a partial length of the body. 24. The method of claim 22, further comprising the step of further inserting the driver into the through bore.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, wherein the plurality of runners are even around the circumference of the through bore 23. The method of claim 22, wherein one of the plurality of runners is of a different shape and / or size than the other runners.   The control member includes a plurality of runners extending between the proximal end and the distal end of the body along the longitudinal axis, the plurality of runners being non-circular around the circumference of the through bore. 23. The method of claim 22, wherein the methods are evenly spaced.

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