Device for operating on a pedicle in a patient

Abstract

A device (1) for performing surgery on a pedicle (2) within a patient, said device (1) comprising a guide portion (3) having a guide channel for guiding a tool, such as a needle or bore, into said pedicle (2), said guide channel extending longitudinally of said guide portion (3), said device (1) further comprising a handle (4) attached or attachable to said guide portion (3), said device (1) further comprising a sleeve (5) that fits snugly and removably around said guide portion (3), said sleeve (5) having a nose or front end (5') retrievably openable through said guide portion (3) that is extendable by retracting said sleeve (5) while said guide portion (3) is housed within said sleeve (5).

Description

[Technical Field]

[0001] The present invention relates to a device for performing surgery on a pedicle in a patient, the device comprising a guide portion having a guide channel for guiding a tool, such as a needle or bore, into the pedicle, the guide channel extending longitudinally of the guide portion, and the device further comprising a handle attached or attachable to the guide portion. [Background technology]

[0002] The pedicle of a vertebra is a short, thick, cylindrical piece of bone that projects upward and backward from the vertebral body.

[0003] U.S. Patent Application Publication No. US2003 / 0236447 describes a device adapted for placing pedicle screws in a patient, comprising: a guide portion having a longitudinally extending guide channel, the guide portion having a first end, a second end, and a tool groove; a handle angularly connected to the first end of the guide portion, the handle providing adequate holding force to maintain the guide so as to stabilize it against the lateral side of the pedicle articular surface with the paraspinous muscle; and an insert configured to fit within the guide channel, the insert having an opening extending longitudinally thereof, the opening having a diameter sized to accommodate a tool to be inserted therein; The above device is disclosed, comprising:

[0004] The guide channel has an appropriate size to accommodate a variety of tools, including drill bits or taps. The channel also provides a passage for a probe or feeler to inspect the position of the threads. A tool groove may be provided within the channel to support the shank of a tool, such as a tap.

[0005] Many inaccuracies and problems have been reported in traditional minimally invasive operations on the pedicles, as seen in the article by Zeng et al., "Analysis of risk factors for adjacent superior vertebral pedicle-induced facet joint violation during the minimally invasive surgery transforaminal lumbar interbody fusion: a retrospective study," published in Eur J Med Res (2015) 20:80.

[0006] Further reference is made to an article by Moon-Chan Kim et al. entitled "Factors affecting the accurate placement of percutaneous pedicle screws during minimally invasive transforaminal lumbar interbody fusion" in Eur Spine J (2011) 20:1635-1643. This article reports that age, sex, body mass index, bone mineral density, diagnosis, operative time, estimated blood loss (EBL), level of fusion, surgeon position, spinal alignment, quality / quantity of multifidus muscle, and depth to the screw insertion point are demographic and anatomical variables that may affect pedicle screw placement. Pedicle dimensions, facet arthritis, screw location (ipsilateral or contralateral), screw length, screw diameter, and screw trajectory angle were considered as screw-related variables that affect pedicle screw placement.

[0007] U.S. Patent Application Publication No. US 2022 / 0233218 discloses a flexible tubular member for guiding the insertion of an instrument into a bone screw fixed in a bone, the member comprising a flexible tubular body and defining a longitudinal axis. The tubular body also defines a proximal end and a distal end opposed to each other along the longitudinal axis. The tubular body further defines a guide channel extending from a proximal opening at the proximal end to a distal opening at the distal end. A connecting member is disposed at the distal end of the tubular body and configured to couple the distal end to a proximal portion of a bone screw. The connecting member has an annular shape around the guide channel and is configured to expand in response to a predetermined tension applied to the tubular body to separate from the bone screw.

[0008] WO 01 / 67966 discloses a device comprising a sleeve having a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The lumen opens at the proximal end and receives an elongate member, such as a cannula or a surgical instrument, therethrough. The sleeve is made of a resilient material and conforms to the contours of at least the distal portion of the elongate member. In one configuration, the distal end wall includes means for opening the end wall to allow the elongate member to advance therethrough. The sleeve may also include internal ribs and flange members.

[0009] European Patent Application Publication No. EP 1462064 discloses a surgical instrument for accessing first and second pedicle sites in a spinal column region, the instrument comprising a blade member slidably positionable along first and second wires, the instrument having a nested arrangement of members including a portal member having an elongated opening for accessing the first and second pedicle sites, and the nested arrangement further comprising a plurality of members configured and sized to progressively enlarge the access opening into the spinal column region.

[0010] It is an object of the present invention to simplify the design of known devices, to provide more accurate placement of pedicle screws or other tools, and to provide easier and more transparent manipulation for the operator / surgeon during surgery on the pedicle.

[0011] In a particular respect, the present invention departs from the prior art in that it is no longer necessary to use an insert fitting in the guide channel of the guide part, but rather the device is provided with one or more of the features of the appended claims.

[0012] The device of the present invention includes a sleeve that removably fits around the guide portion, the sleeve having a nose or forward end that is openable through the guide portion and that is extendable by retracting the sleeve while the guide portion is housed within the sleeve, and a resiliently openable nose that is arranged to close the nose in response to retracting the guide portion.

[0013] The anterior end of the sleeve, if the guide does not extend through it, is convex like a fingertip, which allows for smooth insertion into the skin incision and allows the operator and surgeon to feel the edge of the pedicle to determine the correct position of the sleeve on the pedicle before retracting the sleeve to place the guide in this proper position on the pedicle.

[0014] This allows the sleeve to be first accurately positioned relative to the pedicle, which ensures that the guide within the sleeve is also in the correct position, after which the sleeve can be retracted while the guide remains fixed, thus not adversely affecting the position of the facial guide, and then the resiliently releasable anterior end of the sleeve extends through the guide to engage the pedicle.

[0015] The device of the present invention further has several advantageous features. For the sake of handle reuse and other advantages, the handle and the guide are preferably detachable from each other. Of course, it is also possible for the handle and the guide to form an integral unit. Furthermore, by providing an obtuse angle between the handle and the guide, handling during surgery on the pedicle is greatly improved, allowing the operator to stably maintain the guide in a desired orientation and position relative to the pedicle.

[0016] Preferably, the sleeve is provided with a laterally extending finger handle to allow an operator to retract the sleeve with their fingers.

[0017] To ensure reliable placement of the guide portion relative to the pedicle bone, it is desirable that the sleeve and guide portion fit snugly together and have matching internal and external shapes, preferably rectangular.

[0018] It is further preferred that the guide portion is provided with a navigation tool at or near its forward end, which allows for accurate positioning of the tool within the guide portion, and preferably the navigation tool is an X-ray detectable element.

[0019] Preferably, the navigation tool is provided with one or more X-ray detectable rings.

[0020] It is further preferred that the guide portion has a tip at its front end formed to enable stable positioning of the guide portion on the pedicle bone. Preferably, the tip is V-shaped. The tip provides a so-called dock for accurate positioning of the guide portion on the pedicle bone.

[0021] Advantageously, the guide portion includes two or more guide channels that are at least partially separated from one another, allowing the operator and surgeon to select one of the guide channels for a specific, slightly off-center positioning of a tool or instrument that will be guided through the guide portion and ultimately into the pedicle.

[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating one or more embodiments of the invention and are not to be construed as limiting the invention. [Brief explanation of the drawings]

[0023] [Figure 1A] FIG. 1A provides a different view in which the device of the present invention is brought in proximity to the pedicle to be treated. [Figure 1B] FIG. 1B provides a different view in which the device of the present invention is brought in proximity to the pedicle to be treated. [Figure 2] FIG. 2 provides a different view of the sleeve that forms part of the device of the present invention. [Figure 3] Figure 3 provides a different view of the guide portion forming part of the device of the invention. [Figure 4A] FIG. 4A provides a different view of the device of the present invention positioned on the pedicle to be treated. [Figure 4B] FIG. 4B provides a different view of the device of the present invention positioned on the pedicle to be treated. [Figure 4C] FIG. 4C provides a different view of the device of the present invention positioned on the pedicle to be treated. [Figure 4D] FIG. 4D provides a different view of the device of the present invention positioned on the pedicle to be treated. [Figure 5A] FIG. 5A provides a different view of the device of the present invention while the sleeve is retracted from the guide and held in position over the pedicle to be treated. [Figure 5B] FIG. 5B provides a different view of the device of the present invention while the sleeve is retracted from the guide and held in position over the pedicle to be treated. [Figure 5C] FIG. 5C provides a different view of the device of the present invention while the sleeve is retracted from the guide and held in position over the pedicle to be treated. [Figure 5D] FIG. 5D provides a different view of the device of the present invention while the sleeve is retracted from the guide and held in position over the pedicle to be treated. [Figure 6A] FIG. 6A provides a different view of the device of the present invention while the needle or bore is being guided through the guide portion and to the pedicle to be treated. [Figure 6B] FIG. 6B provides a different view of the device of the present invention while the needle or bore is being guided through the guide portion and to the pedicle to be treated. [Figure 7A] FIG. 7A provides a different view of the device of the present invention during placement of a K-wire within the pedicle to be treated. [Figure 7B] FIG. 7B provides a different view of the device of the present invention during placement of a K-wire within the pedicle to be treated. [Figure 8] FIG. 8 provides a different view of the device of the present invention when placing a K-wire within the pedicle to be treated. [Figure 9A] FIG. 9A provides several views of the front portion of the guide portion of the device of the present invention illustrating the application of one or more guide channels. [Figure 9B] FIG. 9B provides several views of the front portion of the guide portion of the device of the present invention illustrating the application of one or more guide channels. [Figure 9C] FIG. 9C provides several views of the front portion of the guide portion of the device of the present invention illustrating the application of one or more guide channels. DETAILED DESCRIPTION OF THE INVENTION

[0024] Whenever the same reference numbers are used in the figures, these numbers refer to the same parts.

[0025] Figures 1A and 1B show a device 1 of the present invention for operating on a pedicle 2 in a patient. Figure 1A shows the patient's skin 10. The figures do not show other pedicles of the patient's spinal column, which is common knowledge to those skilled in the art and does not require explanation. Moreover, the patient does not form part of the present invention and therefore does not serve to disclose the present invention in a manner sufficiently clear and complete to enable those skilled in the art to work and design devices according to the present invention.

[0026] The device 1 comprises a guide portion 3 comprising an internal guide channel extending longitudinally along the guide portion 3 for guiding a tool, such as a needle or a bore, into the pedicle 2. This is also known to those skilled in the art and therefore not shown.

[0027] The device 1 further comprises a handle 4 which is integral with the guide part 3 or attached or attachable to the guide part 3. The guide part 3 and the handle 4 are shown separately from the other elements of the device 1 in Figure 3, which provides views of the guide part 3 and the handle 4 from different angles.

[0028] Preferably, the handle 4 and the guide portion 3 are detachable from each other. It is further shown in Figures 1A and 1B and 3 that there is an obtuse angle between the handle 4 and the guide portion 3, which is intended to allow the operator to stably orient and position the guide portion 3 relative to the pedicle 2 to be treated during use of the device 1.

[0029] The device 1 is further provided with a sleeve 5 which is shown among other features of the device 1 of the present invention in Figure 2. Figure 2 provides a view of the sleeve 5 from a different angle.

[0030] It should be noted that preferably the sleeve 5 fits snugly and removably around the guide part 3 .

[0031] As shown in Figures 1A and 1B, once the device 1 approaches the pedicle 2 to be treated, in the first manipulation step, the nose or anterior end 5' of the sleeve portion 5 of the device 1 is positioned on the pedicle 2. This is illustrated in Figures 4A-4D. Figures 4A and 4B show the device 1 on the pedicle 2. Figures 4C and 4D show the device 1 without the pedicle 2. Note that in connection with the first manipulation step, the nose or anterior end 5' of the sleeve 5 is convex, like a fingertip.

[0032] The next step is illustrated in Figures 5A-5D. Figures 5A and 5B show the device 1 in a pedicle 2. Figures 5C and 5D show the device 1 without a pedicle 2. In connection with this next step, it should be noted that the sleeve 5 has a resiliently openable nose or anterior end 5' through which the guide portion 3 can be extended by retracting the sleeve 5 while it is received within the sleeve 5 and pressed into the pedicle 2. To retract the sleeve 5, the sleeve 5 is provided with a laterally extending finger handle 6, allowing the operator / surgeon to retract the sleeve 5 with their fingers while simultaneously maintaining the position of the guide portion 3 with their thumb. It should further be noted that the sleeve 5 and guide portion 3 have matching internal and external shapes, respectively, such that the sleeve 5 and guide portion 3 are rotatably fixed about their longitudinal axes. Preferably, the matching internal and external shapes are rectangular. It is also possible, particularly when the sleeve 5 and the guide part 3 have a circular cross section, to provide these parts with a key and a keyway that cooperates with the key, so that the sleeve 5 and the guide part 3 are rotatably fixed.

[0033] In particular, Figures 5C and 5D clearly show the guide portion 3 extending through the nose or anterior end 5' of the sleeve 5 following retraction of the sleeve 5. This action causes the guide portion 3 to directly engage the pedicle bone 2 at the intended position preset by the operator / surgeon when placing the sleeve 5 on the pedicle bone. Figure 5C clearly illustrates that the guide portion 3 has a V-shaped tip at its anterior end, which provides stable positioning on the pedicle 2 to be treated.

[0034] It should be noted that during placement of the sleeve 5 or engagement of the pedicle bone by the guide portion 3, a navigation tool provided at or near the anterior end of the guide portion 3 is used to determine the proper position of the tool of the device 1 on the pedicle 2. The navigation tool can have any form or shape, and is shown in FIG. 9A (described below), although how it can be applied will be clear to those skilled in the art. In a preferred embodiment, the navigation tool is an X-ray detectable element, such as a ring 7, preferably a metal ring, as shown in FIG. 9A. As mentioned above, the form or shape of the navigation tool can be selected depending on the circumstances; instead of being circular like a ring, it may have any other suitable shape. Also, the number of rings can be varied to improve the accuracy of determining the position of the tool advancing within the guide portion 3.

[0035] As shown in Figures 5A to 5D, after the correct positioning and placement of the device 1 on the pedicle 2 is completed, a needle or bore 8 can be inserted into the guide channel of the guide portion 3 as shown in Figures 6A and 6B, and then the needle or bore 8 can be removed and a K-wire 9 can be placed into the pedicle 2 as shown in Figures 7A and 7B and 8.

[0036] 9A-9C, which show a front portion of the guide part 3, illustrating that the guide part 3 may comprise a single guide channel (FIG. 9A), a double guide channel (FIG. 9B), or a triple guide channel (FIG. 9C). Note that two or more guide channels are at least partially separated from each other.

[0037] Embodiments of the present invention may include any combination of features disclosed herein independently of each other. Although the present invention has been described above with reference to exemplary embodiments thereof, the present invention is not limited to these specific embodiments, which may be varied in many ways without departing from the present invention. Therefore, the described exemplary embodiments should not be used to strictly interpret the appended claims accordingly. On the contrary, the embodiments are not intended to limit the claims to these exemplary embodiments, but are merely intended to explain the wording of the appended claims. Therefore, the scope of protection of the present invention should be interpreted solely in accordance with the appended claims, and any ambiguities in the wording of the claims should be resolved using these exemplary embodiments.

[0038] Variations and modifications of the present invention will be apparent to those skilled in the art, and it is intended that the appended claims cover all such modifications and equivalents. The entire disclosures of all documents, applications, patents, and publications cited above are incorporated herein by reference. Unless expressly designated above as "essential," none of the various components or their interrelationships is essential to the operation of the present invention. Rather, desired results may be achieved by substituting the various components and / or rearranging their interrelationships.

Claims

1. A device (1) for performing surgery on a pedicle (2) in a patient, said device (1) comprising a guide portion (3) having a guide channel for guiding a tool, such as a needle or a bore, into said pedicle (2), said guide channel extending longitudinally of said guide portion (3), said device (1) further comprising a handle (4) attached or attachable to said guide portion (3), said device (1) further comprising a sleeve (5) removably fitted around said guide portion (3), and The device (1) is characterized in that the sleeve (5) has a nose or front end (5') that can be opened through the guide portion (3) and can be extended by retracting the sleeve (5) while the guide portion (3) is housed within the sleeve (5), wherein the nose or front end (5') of the sleeve (5) is resiliently openable, and the front end (5') of the sleeve (5) is convex like a fingertip when the guide portion (3) does not extend through the front end (5').

2. 2. The device according to claim 1, characterized in that the handle (4) and the guide part (3) are detachable from each other.

3. 3. The device according to claim 1 or 2, characterized in that an obtuse angle exists between the handle (4) and the guide part (3) so that an operator can stably orient and position the guide part (3) relative to the pedicle (2).

4. A device according to any one of claims 1 to 3, characterized in that the sleeve (5) is provided with a laterally extending finger handle (6) to enable an operator to retract the sleeve (5) with his fingers.

5. A device according to any one of claims 1 to 4, characterized in that the sleeve (5) and the guide part (3) have matching internal and external shapes, respectively, to have a snug fit relative to each other.

6. 6. A device according to claim 5, characterized in that the sleeve (5) and the guide part (3) have matching keys and keyways.

7. 7. A device according to claim 5 or 6, characterized in that the matching internal and external shapes are rectangular.

8. A device according to any one of claims 1 to 7, characterized in that at or near its front end the guide part (3) is provided with a navigation tool.

9. 10. The device of claim 8, wherein the navigation tool is an X-ray detectable element.

10. 10. A device according to claim 8 or 9, characterized in that the navigation tool comprises an X-ray detectable ring (7) or rings.

11. 11. The device according to any one of claims 1 to 10, characterized in that the guide part (3) has at its anterior end a tip (3') formed to enable stable positioning of the guide part (3) on the pedicle (2).

12. 12. A device according to claim 11, characterized in that the tip (3') is V-shaped.

13. Device according to any one of the preceding claims, characterized in that the guide part (3) comprises two or more guide channels at least partially separated from each other.

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