INSTRUMENT FOR USE IN SURGERY
20230149057 · 2023-05-18
Inventors
- Timo BIEDERMANN (Trossingen, DE)
- Markku BIEDERMANN (Key Biscayne, FL, US)
- Achim Schünemann (Villingen-Schwenningen, DE)
Cpc classification
A61B17/8872
HUMAN NECESSITIES
A61B17/7076
HUMAN NECESSITIES
A61B17/7082
HUMAN NECESSITIES
International classification
A61B17/70
HUMAN NECESSITIES
A61B17/04
HUMAN NECESSITIES
Abstract
An instrument for use in surgery includes a hollow shaft connectable to a drive shaft of a bone anchor insertion device in a rotationally fixed manner, a needle holder configured to hold a needle and movable axially relative to the hollow shaft, an actuator rotatable relative to the hollow shaft, and a transmission member connectable to the needle holder and movable axially relative to the actuator. The transmission member is positionable around at least part of the hollow shaft and includes a first advancement surface engageable with a second advancement surface of the hollow shaft to convert a rotational movement of the actuator into axial movement of the needle holder relative to the hollow shaft for axially advancing and retracting the needle held by the needle holder.
Claims
1. An instrument for use in surgery, the instrument being connectable to a bone anchor insertion device that comprises a drive shaft configured to engage a bone anchor, the drive shaft defining a coaxial channel for receiving a needle therethrough, the instrument comprising: a hollow shaft connectable to the drive shaft in a rotationally fixed manner; a needle holder configured to hold a needle and movable axially relative to the hollow shaft; an actuator rotatable relative to the hollow shaft; and a transmission member connectable to the needle holder and movable axially relative to the actuator, wherein the transmission member is positionable around at least part of the hollow shaft and comprises a first advancement surface engageable with a second advancement surface of the hollow shaft to convert rotational movement of the actuator into axial movement of the needle holder relative to the hollow shaft for axially advancing and retracting the needle held by the needle holder relative to the hollow shaft.
2. The instrument of claim 1, wherein the needle holder is positionable at least partially within the hollow shaft and is movable along a longitudinal axis of the hollow shaft.
3. The instrument of claim 1, wherein the transmission member comprises a sleeve-like portion that is positionable at least partially around the hollow shaft.
4. The instrument of claim 1, wherein the transmission member comprises at least one engagement member that is configured to extend through a recess in the hollow shaft to engage the needle holder.
5. The instrument of claim 1, wherein the first advancement surface is provided at an inner surface of the transmission member and the second advancement surface is provided at an outer surface of the hollow shaft.
6. The instrument of claim 1, wherein the first advancement surface and the second advancement surface each comprises a thread.
7. The instrument of claim 1, wherein the actuator comprises an actuator wheel positionable at least partially around the hollow shaft and a guiding structure for guiding the transmission member when the actuator is rotated relative to the hollow shaft.
8. The instrument of claim 7, wherein the actuator wheel and the hollow shaft are connected in a manner such that when the actuator wheel is rotated, the actuator wheel is configured to be held at defined rotational increments relative to the hollow shaft.
9. The instrument of claim 1, further comprising a handle portion connectable to the hollow shaft to transmit torque to the hollow shaft.
10. The instrument of claim 9, wherein the handle portion defines an elongate passage into which the hollow shaft is configured to extend.
11. The instrument of claim 10, wherein a portion of the actuator is configured to extend into the elongate passage of the handle portion.
12. The instrument of claim 9, further comprising a fixation member configured to fixedly connect the hollow shaft to the handle portion.
13. The instrument of claim 1, further comprising a needle position indication device configured to indicate an axial position of an inserted needle with respect to a shank of a bone anchor.
14. The instrument of claim 1, further comprising a length indication device configured to indicate a length of a selected bone anchor, wherein the length indication device is adjustable to accommodate bone anchors with different lengths.
15. The instrument of claim 1, wherein the hollow shaft comprises an end portion that is releasably connectable to an end portion of the drive shaft.
16. The instrument of claim 15, wherein the end portion of the hollow shaft comprises a standard coupling.
17. The instrument of claim 1, wherein the needle holder is configured to releasably receive the needle without disassembling the instrument.
18. A method of implanting a bone anchor into bone with a surgical instrument comprising a bone anchor insertion device that comprises a drive shaft configured to engage the bone anchor, the drive shaft defining a coaxial channel for receiving a needle therethrough, and an instrument comprising a hollow shaft connectable to the drive shaft in a rotationally fixed manner, a needle holder configured to hold a needle and movable axially relative to the hollow shaft, an actuator rotatable relative to the hollow shaft, and a transmission member connectable to the needle holder and movable axially relative to the actuator, wherein the transmission member is positionable around at least part of the hollow shaft and comprises a first advancement surface engageable with a second advancement surface of the hollow shaft to convert rotational movement of the actuator into axial movement of the needle holder relative to the hollow shaft for axially advancing and retracting the needle held by the needle holder relative to the hollow shaft, the method comprising: advancing a bone anchor to the bone while the bone anchor is engaged by the bone anchor insertion device and the bone anchor insertion device is connected to the instrument and when a needle is held by the needle holder and extends distally past a tip of the bone anchor; rotating the actuator while holding a rotational orientation of the hollow shaft to advance the needle into the bone while maintaining an axial position of the bone anchor; rotating the hollow shaft while holding a rotational orientation of the actuator to advance the bone anchor over the needle into the bone while maintaining an axial position of the needle; detaching the bone anchor insertion device and the needle from the bone anchor.
19. The method of claim 18, wherein a held needle is removable from or adjustable relative to the needle holder without disassembling any other portion of the instrument.
20. An instrument for use in surgery, the instrument being connectable to a bone anchor insertion device that comprises a drive shaft configured to engage a bone anchor, the drive shaft defining a coaxial channel for receiving a needle therethrough, the instrument comprising: a hollow shaft connectable to the drive shaft in a rotationally fixed manner; a needle holder configured to hold a needle and movable axially relative to the hollow shaft; an actuator rotatable relative to the hollow shaft; a transmission member connectable to the needle holder and movable axially relative to the actuator, the transmission member comprising a first advancement surface engageable with a second advancement surface of the hollow shaft to convert rotational movement of the actuator into axial movement of the needle holder relative to the hollow shaft for axially advancing and retracting the needle held by the needle holder relative to the hollow shaft; and a closed ring configured to extend entirely around at least part of the actuator, wherein the closed ring is fixedly connected to and movable together with the transmission member relative to the actuator.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings. In the drawings:
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DETAILED DESCRIPTION
[0043] Referring to
[0044] Referring further to
[0045] The actuating mechanism includes an actuator 60 and a transmission member 70. The actuator 60 is rotatable relative to the hollow shaft 20 and the drive shaft of the shank inserter 10. The transmission member 70 is guided by the actuator 60 in a manner such that when the actuator 60 is rotated, the transmission member 70 follows the rotational movement of the actuator and, at the same time, advances axially relative to the hollow shaft 20. In addition, the transmission member 70 is connected to the needle holder 50 in a manner such that the needle holder 50 follows the axial advancement of the transmission member 70. Thus, the transmission member 70 is configured to convert a rotational movement of the actuator 60 into a translational movement of the needle holder 50. By means of this, the needle 4 can be advanced and retracted relative to the bone anchor 1 independently from a position of the bone anchor 1. An axis of rotation R of the instrument 100, which is also a central longitudinal axis of the instrument, is coaxial with the axis of rotation of the shank inserter 10 and the screw axis of the bone anchor 1.
[0046] The parts of the instrument 100 will now be explained in greater detail. Referring additionally to
[0047] The channel then widens towards the rear end 20b into a needle holder receiving section 26, which serves for receiving the needle holder 50 therein. The needle holder receiving section 26 has a length such that the needle holder 50 can move therein in an axial direction along a defined length. At least one, preferably four, axially elongate slots 27 that are closed at both ends are formed in the wall of the hollow shaft 20 equidistantly in the circumferential direction. The slots 27 permit pins 73 to extend therethrough for holding the needle holder 50, as described in greater detail below. When the pins 73 abut against or are close to the rear end of the slots 27 that are located closer to the rear end 20b of the hollow shaft 20, respectively, the needle holder 50 is in a rearmost position (
[0048] Between the annular projection 24 and a position at a distance from the rear end 20b, the outer surface of the hollow shaft 20 includes an advancement structure, which in this embodiment is a thread 200. The thread 200 is configured to cooperate with an advancement structure provided on the transmission member 70 to facilitate an axial advancement of the transmission member 70 along the outer surface of the hollow shaft 20. The outer diameter of this threaded section of the hollow shaft 20 may be smaller than that of the annular projection 24. The type of thread depends on the application and the desired dependency between the action of the actuator 60 and the advancement of the needle holder 50. Thus, the pitch, the threadform, and the number of thread entries may be selected accordingly. A multiple thread may be used for obtaining a greater advancement of the needle. In the embodiment, a thread with three entries is used. However, a single thread, a double thread, or any other multiple thread may also be applied.
[0049] Adjacent to the rear end 20b, a reduced outer diameter section 28 with an external thread is formed that is configured to cooperate with an internal thread in a bore of the fixation member 40 (
[0050] In the following, the coupling portion 15 which couples the hollow shaft 20 to the drive shaft will be described in greater detail. The coupling portion 15 is exemplary and any outer suitable coupling can also be used. As best seen in
[0051] Referring to
[0052] As shown in
[0053] At the rear end 50b, two axially extending recesses 58 that are offset by 180° from each other are formed in the wall of the needle holder 50, that permit the projections 8a of the intermediate portion 8 of the needle 4 to be guided therethrough when the needle 4 is inserted. At a distance from the rear end 50b, the recesses 58 continue into end portions 59 which extend in the circumferential direction, and thus are transverse to the axial portion of recesses 58. The end portions 59 extend circumferentially in a same rotational direction, so that when the projections 8a of the needle 4 reach the end portions during insertion of the needle, rotation in one direction moves the projections into the end portions 59 of the recesses 58, respectively, and rotation in the other direction moves the projections out of the end portions.
[0054] Referring to
[0055] The actuator tube 64 has a front end 64a and a rear end 64b, and a plurality of axially extending slits 66, in the embodiment four slits. The slits 66 are open towards the front end 64a and closed towards the rear end 64b, so that four tube sections 67 are formed. The tube sections 67 are mounted with the front end 64a into the recesses 63 of the actuator wheel 61. Thereby, the actuator tube 64 protrudes from the rear end 61b of the actuator wheel 61, with a smaller diameter compared to that of the actuator wheel. The length of the actuator tube 64 is such that in the mounted state, the rear end 64b of the actuator tube extends up to a small distance from the rear wall of the handle portion 30. When the actuator is mounted to the hollow shaft 20, the mounting pins 75 that connect the ring 76 with the transmission member 70 can extend through the slits 66, respectively.
[0056] The actuator 60 may be mounted to the hollow shaft 20 via a spring biased rotatable connection. As shown in particular in
[0057] The transmission member is shown in greater detail in
[0058] The transmission member 70 is connected to the needle holder 50 via the connection pins 73 as shown in
[0059] At an axial position between the rear end 70b and the groove 72, a plurality, in the embodiment four, equidistantly arranged threaded through holes 74 are formed that serve for receiving mounting pins 75 for mounting a needle position indication device in the form of a ring or sleeve 76 to the transmission member 70. The ring 76 has substantially the same axial length and an inner diameter that permits mounting around the tube portion 64 of the actuator 60. The inner wall of the ring 76 is threadless, so that the ring 76 can slide along the tube portion 64. At positions corresponding to the threaded through holes 74 in the transmission member 70, the ring 76 defines unthreaded holes 77 which permit only a threaded front portion 75a of the mounting pins 75 to extend therethrough and engage the threaded holes 74 of the transmission member 70. It shall be noted that the ring 76 is thinner in the radial direction compared to the transmission member 70, since the ring 76 has to fit into the space between the actuator and the handle portion in the radial direction. In the outer surface of the ring 76, a circumferential indication mark 78 is provided which may be, for example, a groove, that may be provided with a coloring and/or a colored ring. Hence, when the transmission member 70 moves, the ring 76 with the indication mark 78 moves in the same way, for example, a same axial distance. Therefore, the indication mark 78 is configured to display the axial position of the needle holder 50, and therefore the axial position of the tip 6 of the needle relative to the tip 3 of the bone anchor 1. For this purpose, there is a window in the handle portion 30, as explained in greater detail below.
[0060] Turning now in addition to
[0061] Adjacent to the rear end 30b, a cylindrical recess 34 with a bottom 34a is formed that is sized to receive a portion of the fixation member 40 (see
[0062] In addition, a window 36 is provided in the handle portion 30 that exposes a portion of the inside of the handle portion. More specifically, the window 36 exposes at least a portion of the ring 76 with the marking 78. Thus, the marking 78 that is indicative of the position of the needle holder 50 can be used for adjusting the position of the needle holder 50, and thus the position of the needle 4. The window 36 may have a rectangular shape with rounded edges, with a length that is greater than a difference between lengths of the longest and the shortest shanks of bone anchors that can be used, plus the length that the needle 4 is allowed to move. A groove 38 is formed in the wall of the handle portion 30 for receiving a shank length indication device in the form of a slide 90 that is configured to indicate the possible travel path of the needle holder 50 and which serves for setting a shank length of the bone anchor that is actually being used. The groove 38 has a substantially rectangular contour and a flat bottom. At the tapered portion 33 of the handle 30, the height of outer wall of the groove decreases towards the front end 30a, such that a portion of the bottom is free which permits the slide 90 to enter the groove 38 easily. Inside the groove 38 there are protrusions 38b along at least a portion of the length of the window for cooperating with the slide 90. At the outer wall of the handle portion 30, around the window 36, are markings 39 that are configured to indicate the length of the shank of the bone anchor that is being used. In the embodiment, the length is indicated in increments wherein, for example, even numbers are indicated at one side of the window and odd numbers are indicated at the opposite side of the window. For example, if the smallest length of a shank that can be used is 35 mm and a greatest length of a shank that can be used is 60 mm, the even numbers between 40 mm and 60 mm with an increment of 10 mm are indicated on one side of the window 36 and the odd numbers between 35 mm and 55 mm are indicated on the opposite side of the window. The markings 39 are arranged such that the smallest length is displayed closer to the rear end 30b of the handle portion 30, and the displayed lengths increase towards the front end 30a.
[0063] As shown in
[0064] On the surface of the countersink 92, markings are provided that can be aligned with the markings 39 on the handle portion 30 when the slide 90 is moved. In greater detail, close to the rear end 90b, a first type of marking 94b may be provided that is configured to be aligned with one of the markings 39 around the window 36 that indicate possible shank lengths. The first type of marking can be, for example, two arrows pointing to the center of the slot 91 in the circumferential direction of the handle portion 30, such that, when the slide 90 is at a position in which the two arrows are aligned with a marking 39 on the handle portion 30, the marking 94b indicates the length of a shank of an inserted bone anchor 1. This first type of marking 94b may have a color, for example, green. Moreover, a second type of marking 94a may be provided close to the front end 90a of the slide 90. This second type of marking 94a may indicate the maximum admissible projection of the needle 4 out of the shank 2. In other words, the second type of marking indicates the maximum admissible or desirable travel path of the needle holder 50 to ensure the maximum admissible projection of the needle. The marking 94a may also include two arrows that point with their tips towards each other. A color of the second type of marking may be red, for example, to indicate the limit of the admissible advancement of the needle 4. In between the first and the second type of markings, there may be a third type of marking 94c that may include equidistantly spaced apart dashes and/or dots on each side of the slot 91, wherein the markings 94c are offset from each other on one side relative to the other side. The markings 94c may indicate the advancement of the needle in increments.
[0065] Generally, the markings 39 on the handle portion 30 provide a first scale indicative of possible lengths of the shank of a bone anchor 1, while the markings on the slide 90 provide a second scale indicative of the possible positions of the tip 6 of the needle with respect to the tip of the bone anchor 1. Lastly, the slide 90 defines on each of the long sides, at approximately the middle of the long sides, recesses, for example, two V-shaped recesses 95 in the outer edge of the slide. The recesses 95 are configured to cooperate with the protrusions 38b inside the groove 38. Thereby, the adjustment of the markings on the slide 90 relative to the markings 39 on the handle portion 30 may be more easily facilitated, and the slide may be held at specific positions.
[0066] As further depicted in
[0067] The parts and portions of the instrument and/or the bone anchor insertion device, the bone anchor, and/or the needle may be made of any material, preferably, however, of a bio-compatible material, such as titanium or stainless steel, or any other bio-compatible metal or metal alloy, or plastic material. For bio-compatible alloys, a NiTi-alloy, for example Nitinol, may be used. Other materials that can be used are, for example, Magnesium or Magnesium alloys, or bio-compatible plastic materials that can be used may be, for example, Polyether ether ketone (PEEK) or Poly-L-lactide acid (PLLA). The parts can be made of the same or of different materials from one another. For the instrument, a material that is easy to clean may be preferred.
[0068] The needle holder 50, the hollow shaft 20, the transmission member 70 with the ring 76, the handle portion 30 with the slide 90, and the actuator 60 are usually preassembled such that their respective front ends face in the direction of the connection portion 15. When the needle holder 50 is placed into the hollow shaft 20, the transmission member 70 is screwed onto the hollow shaft 20 from the rear end thereof, and the pins 73 are inserted through the mounting hole 79, passed through the slots 27 of the hollow shaft 20 and screwed into the threaded holes 52 of the needle holder 50. The actuator 60 is placed with the actuator wheel 61 around the hollow shaft 20 and the set screws 601 are tightened. The ring 76 is mounted around the actuator tube 64 and fixed with the mounting pins 75 to the transmission member 70, and the actuator tube 64 is mounted to the actuator wheel 61. After that, the hollow shaft 20 is fixed to the handle portion 30 via the fixation member 40 that is screwed onto the threaded posts 280 of the hollow shaft 20. Tightening the fixation member 40 firmly fixes the hollow shaft 20 to the handle 30 so that rotation of the handle 30 also rotates the hollow shaft 20. The actuator 60 remains rotatable with respect to the hollow shaft 20 and with respect to the handle portion 30.
[0069] To use the instrument 100 with a shank inserter 10, the optional coupling portion 15 is mounted to the connection portion 21 of the hollow shaft 20. The instrument 100 preassembled in this manner can be connected to a shank inserter 10. To accomplish this, the connection portion of the drive shaft is inserted into the connection portion 21 of the hollow shaft until the connection portion of the drive shaft is received in the receiving section 23, so that the form-fit engagement allows transmission of torque to the drive shaft. The shank inserter may be already connected to a bone anchor 1 to be inserted into bone, or the bone anchor 1 can be fixed to the shank inserter 10 when the shank inserter has already been connected to the instrument 100.
[0070] In operation, when the actuator wheel 61 is rotated, the rotational movement of the actuator tube 64 forces the transmission member 70 to travel in an axial direction via the engagement of the thread 71 of the transmission member 70 with the thread 200 of the hollow shaft 20. Since the transmission member 70 is connected via the pins 73 to the needle holder 50, the needle holder 50 will travel axially together with the transmission member 70.
[0071] The needle 4 can be inserted and removed by means of a push and turn action as follows. When the projections 8a are received in the end portions 59, the needle 4 is secured against inadvertent removal from the needle holder 50. When the shoulder 7a of the holding portion of the needle 4 abuts against the washer 57, the spring 55 urges the washer against the shoulder 7a, so that the needle 4 as a whole is biased towards the rear end 50b of the needle holder 50. Thereby, the projections 8a are held in the transverse end portions 59 of the axial recesses 58. Removal of the needle 4 is effected by pushing the holding portion of the needle against the washer 57, which frees the projections 8a so that they can be moved out of the transverse end portions 59 by rotating the needle in a counter or opposite direction compared to when the needle is attached to the needle holder. For example, in the embodiment, the end portions 59 extend in the counterclockwise direction when viewed from the read end 50b, so that pushing and rotating the needle in the counterclockwise direction locks the needle 4 in the needle holder 50, while pushing and rotating the needle in the clockwise direction releases the needle 4 from the needle holder 50. This push and turn action allows for a quick and simple mounting and removal of the needle. The rod portion 5 of the needle may be exchanged relative to the holding portion, or the entire rod portion together with the holding portion of the needle 4 can be replaced or exchanged.
[0072] Referring to
[0073] Once the needle 4 has been inserted and locked in the needle holder 50, the position of the needle is adjusted with the actuator. By rotating the actuator wheel 61, for example, in the clockwise direction, the needle 4 is advanced, and by rotating the actuator wheel, in this example, in the counterclockwise direction, the needle is retracted. During adjustment of the position of the needle 4, the marking 78 on the ring 76 displayed through the window 36 and the slot 91 indicates the position of the tip 6 of the needle 4 relative to the tip 3 of the bone anchor 1.
[0074] As shown in
[0075] Next, as depicted in
[0076] As further shown in
[0077] Finally, the shank inserter 10 can be decoupled from the bone anchor 1 together with the instrument 100 still attached to the shank inserter and with the needle 4 still extending through the entire device. Alternatively, the needle 4 can be removed first, and the shank inserter 10 can then be released from the bone anchor thereafter.
[0078] Since the path the needle can travel covers about a length of the shank of a usual bone anchor or more, the instrument 100 and the same needle 4 can be used in connection with different bone anchors having different lengths. The needle position can be monitored during use as it is displayed on the slide 90.
[0079] Referring to
[0080] It shall be noted that instead of a navigation array, other secondary instruments can also be used via the adapter member 1000.
[0081] Referring to
[0082] The needle holder 50′ is cylindrical, similar to the previous embodiment, and defines a coaxial channel for passing through the rod portion 5 of the needle 4′ and for receiving at least part of the holding portion of the needle. A front portion 51′ of the channel is configured to receive the cylindrical front portion 7′ of the needle. A rear portion 53′ of the channel has an internal thread 53a′ that is configured to cooperate with the external thread 81 of the holding portion of the needle. The rear portion 53′ may be located between the holes 52 for the pins 73 and the rear end 50b. At the transition between the front portion 51′ and the rear portion 53′ of the channel, a step 51a′ may be formed that may serve as an abutment to limit the insertion of the needle into the needle holder 50′. Moreover, when the needle 4′ is screwed into the needle holder 50′, the needle 4′ can be tightened against the abutment. This may result in a stronger and safer connection. Between the rear end 50b and the rear portion 53′, a coaxial bore 53b′ may be formed, and the head portion 9′ may abut against the rear end 50b. The needle holder 50′ may be used in the instrument instead of the needle holder 50.
[0083] In use, when the needle holder 50′ is inserted into the hollow shaft 20, the needle 4′ can be removed and/or exchanged by means of screwing the needle into and out of the needle holder. Preferably the needle holder 50′ is in the rearmost position when the needle 4′ is mounted or exchanged. The threaded connection simplifies the handling of the needle and allows for a quicker exchange of the needle.
[0084] Further modifications of the instrument or the parts thereof may be possible. In particular, the shapes of the various parts are not limited to the specific shapes shown in the embodiments. The instrument can also be used, for example, for inserting a syringe for injecting bone cement or other substances after or instead of a needle as shown in the embodiment. For the actuating mechanism, any suitable actuating mechanism that can convert a rotational motion of an actuator into a translational motion of the needle holder can be used. The instrument can also be used in connection with, for example, a drill instead of a shank inserter, or with other suitable surgical instruments. The instrument can also be used without a needle or with needles of different types and lengths.
[0085] While the present invention has been described in connection with certain exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but is instead intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims, and equivalents thereof.