Patient-specific navigation guide

Abstract

A patient-specific navigation guide (1) for use in spinal surgery includes a first guide member (2) and a second guide member (3), both of which are integral with a support frame (4) and extend along respective longitudinal deployment axes (2a, 3a) from proximal openings (2p, 3p) to distal openings (2d, 3d) for guiding surgical instruments to a first vertebra (100) of the patient, and contact members (14, 15, 16) designed to mate with corresponding contact areas of the first and second vertebrae of the patient, the first guide member (2) and the second guide member (3) being substantially opposed to a median plane (X) perpendicular to a line connecting the longitudinal axes (2a, 3a) of the first guide member (2) and the second guide member (3). The guide (1) includes a single additional third guide member (6) adapted to abut the second vertebra (200), the third guide member being integral with the support frame via a plate connected to the first or second guide member.

Description

[Technical field]

[0001] The present invention relates to the technical field of orthopedic surgery, and more particularly to a patient-specific navigation guide for the spine for use in spinal surgery. [Background technology]

[0002] Patient-specific guides are disposable templates, individually designed to match the bone anatomy obtained from computed tomography images of a particular patient. Surgical procedures such as drilling and incisions can be planned in the preoperative phase using computer-aided technology, and the resulting patient-specific guide allows the surgeon to precisely replicate the planned procedure on the patient's body.

[0003] Patient-specific guides are being employed in various areas of orthopaedic surgery, including spine surgery.

[0004] In this field, patient-specific guides are mostly used to assist the surgeon during the insertion of pedicle screws, so that the screws can be inserted into the bone structure in an optimal pre-planned insertion direction.

[0005] The sacral vertebrae have a different shape than the cervical, thoracic, or lumbar vertebrae. In certain cases of pathologies involving the lowest lumbar vertebrae, such as spondylolisthesis - a condition that occurs when the fifth lumbar vertebra (L05) slides forward toward the abdomen relative to the first sacral vertebra (S01) - or in cases of scoliosis or lordosis, it may be necessary to perform surgery on the first sacral vertebra, specifically S01 and S02.

[0006] The size of the guides currently used for these procedures is quite large, requiring four tubular guide elements to simultaneously act on two adjacent vertebrae, S01 and S02.

[0007] As spinal surgery tends to be performed using minimally invasive surgery, there is a tendency to minimize the size of the wound. In light of this, when operating on the first sacral vertebrae, S01 and S02, the surgeon's aim is to make the size of the incision as small as possible and to limit its length as much as possible. For example, if the operation involves intervention on L05, S01 and S02, in the prior art, the incision would still have to be made from L05 to S02.

[0008] Insertion of these known navigational guides requires that the incision be very extensive to enlarge the wound and allow for the guide to be inserted and positioned.

[0009] When incisions are enlarged, the surgery is no longer minimally invasive, resulting in longer surgery times and longer patient recovery times. Additionally, such incisions extend into particularly mobile areas of skin, such as near the tailbone, where wounds have a hard time healing.

[0010] For example, navigation guides known and described in EP 2749235, EP 3217895 or EP 2502582 cannot be used in posterior sacral or sacro-alar fixation procedures (S02-AI screws) because they are limited to the S01 level and optimized for convergent or slightly divergent trajectories of the screws in the anterior-posterior direction (the typical trajectories of S02-AI screws are highly divergent). Furthermore, the masks are too cumbersome in terms of the incisions required for S02-AI screws and also cause greater instability due to the surgical technique used to implant S02 screws. Summary of the Invention

[0011] The object of the present invention is to overcome the drawbacks of the prior art, in particular to propose a patient-specific navigation guide that is not cumbersome and can be used in minimally invasive surgery at the S01 and S02 vertebrae.

[0012] Another object of the present invention is to generate a patient-specific navigation guide that allows safe and accurate insertion of screws even in difficult trajectories without continuous beam control.

[0013] It is also an object of the present invention to provide a patient-specific navigation guide that can provide simplified positioning on the patient's bony structures in a stable and safe manner.

[0014] These and other objects and advantages are achieved by a patient-specific navigation guide as set forth in the accompanying claims and a patient-specific navigation kit as set forth in claim 10. overview A first aspect of the present invention includes a patient-specific navigation guide for use in spinal surgery, the navigation guide including first and second guide members, both of which are integral with a support frame and extend along respective longitudinal advancement axes from a proximal opening to a distal opening for guiding a surgical instrument to a first vertebra of the patient. The guide also includes contact members designed to match corresponding contact areas on the patient's vertebrae to define a unique mating configuration of the patient-specific navigation guide to the patient's vertebrae. The first and second guide members are substantially opposed to a median plane that is perpendicular to a line connecting the longitudinal axes of the two guide members.

[0015] The first and second guide members are preferably associated with the first vertebra.

[0016] The guide also includes a single additional guide member in addition to the first two, specifically a third guide member adapted for appositional abutment against a second vertebra adjacent and contiguous with the first vertebra.

[0017] The navigation guide comprises a total of three guide members, the first two of which are symmetrical about a median plane perpendicular to a line joining the longitudinal axes of the two guide members, and the third guide member is connected only to the first or second guide member.

[0018] The third guide member is preferably integral with the support frame via a plate connected to the first or second guide member.

[0019] Advantageously, in use, the plate extends from the support frame in a caudal direction along the patient's spine.

[0020] The three guide members are preferably tubular.

[0021] Advantageously, the third guide member extends along its longitudinal axis of deployment from the proximal opening to the distal opening for guiding a surgical instrument to a second vertebra adjacent to the first vertebra, the longitudinal axis of deployment being transverse to the median plane and transverse to the longitudinal axes of deployment of the first and second guide members.

[0022] The plate preferably defines, on its proximal surface, ie the side facing the patient's vertebra, a contact surface with the lamina of a second vertebra of the patient.

[0023] Advantageously, the support frame comprises a bridge connecting the first and second guide members, the bridge also including a primary contact member adapted to be coupled with the sacral crest or spinous process of the first vertebra.

[0024] The bridge should preferably comprise gripping elements, substantially above the main contact members, which also act as pressure elements to hold the device in place during use.

[0025] Advantageously, below the contact member of the bridge is a notch adapted to accommodate the spinous process or sacral crest.

[0026] A second aspect of the invention includes a patient-specific navigation guide kit including two navigation guides, a first guide having a third guide member connected to the first guide member via a plate to allow drilling a hole on one side of a second vertebra, and a second guide having a third guide member connected to the second guide member via a plate to allow drilling a hole on a side of the second vertebra opposite a longitudinal line of the spinal column to which the first and second vertebrae belong. [Brief description of the drawings]

[0027] The described and claimed patient-specific navigation guide is also illustrated in the following exemplary, non-exhaustive figures. [Figure 1] FIG. 1 is a perspective view of a first patient-specific navigation guide according to the present invention. [Diagram 2] FIG. 2 is a bottom view of the guide shown in FIG. 1. [Diagram 3] FIG. 2 is a top view of the guide shown in FIG. 1. [Figure 4] FIG. 2 is a side view of the guide shown in FIG. [Diagram 5] FIG. 2 is a perspective view of a second patient-specific navigation guide in accordance with the present invention. [Figure 6] FIG. 2 is a bottom view of the guide shown in FIG. 1. [Figure 7] FIG. 2 is a top view of the guide shown in FIG. 1. [Figure 8] FIG. 2 is a side view of the guide shown in FIG. [Figure 9] 2 is a perspective view of the guide of FIG. 1 in an in-use configuration and attached to a patient's vertebrae. [Figure 10] 6 is a perspective view of the guide of FIG. 5 in an in-use configuration and attached to a patient's vertebrae. [Figure 11] FIG. 10 is a side view of the guide in the use configuration shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] With reference to the attached figures, number 1 indicates a patient-specific navigation guide according to a first aspect of the present invention.

[0029] The guide 1 is adapted to act on a first vertebra 100, in particular S01, and a second vertebra 200 adjacent and contiguous to the first vertebra 100, in particular S02.

[0030] The guide 1 comprises a first guide member 2 and a second guide member 3 , which are preferably tubular, both of which are integral with a support frame 4 .

[0031] Both the first guide member 2 and the second guide member 3 extend from respective proximal openings 2p, 3p to respective distal openings 2d, 3d along respective longitudinal deployment axes 2a and 3a, and each have an internal channel 5 along the respective longitudinal axes 2a, 3a.

[0032] In the following description, the terms proximal and distal refer to the patient.

[0033] These guide members 2 and 3 accommodate in their axial channels 5 surgical instruments such as Kirschner wires, cannulated drill bits or screws adapted to act on the first vertebra 100 of the patient.

[0034] As can be seen in the accompanying figures, the first guide member 2 and the second guide member 3 are substantially symmetrical about a median plane X that is perpendicular to a line connecting the longitudinal axes 2a and 3a of the first guide member 2 and the second guide member 3.

[0035] This median plane X passes, in use, through the longitudinal line of the patient's spinal column in which the first vertebra 100 and the second vertebra 200 reside.

[0036] The first guide member 2 and the second guide member 3 can cover a portion of the first vertebra 100 by juxtaposition and can be coupled to the first vertebra 100 by contact only, without a fixed and immovable bond.

[0037] Advantageously, the navigation guide 1 that is the subject of the present invention comprises, in addition to the first guide member 2 and the second guide member 3, only one additional guide member, in particular a third guide member 6 adapted to be coupled to a second vertebra 200 adjacent to and contiguous with the first vertebra 100.

[0038] Thus, overall, the guide only has three guide members: a first guide member 2 and a second guide member 3 that cover a portion of a first vertebra 100 and are coupled to the first vertebra 100 by juxtaposition, and a third guide member 6 that covers a portion of an adjacent second vertebra 200 and are coupled to the second vertebra 200 by juxtaposition. These guide members are not integrally constrained to the vertebrae, but are coupled only by contact.

[0039] The third guide member 6 is integral with the support frame 4 by virtue of a plate 8 which is only connected to one of the other two guides, i.e. the first guide member 2 or the second guide member 3. This plate 8, considering the guides in their use configuration, extends in a caudal direction from the support frame 4, from the first vertebra (S01) 100 on which the first and second guide members 2 and 3 rest, to the second vertebra (S02) 200 on which the third guide member 6 rests.

[0040] The third guide member 6 also extends along its longitudinal deployment axis 6a from a proximal opening 6p to a distal opening 6d.

[0041] The third guide member 6 has an internal channel 7 extending along a longitudinal axis 6a into which a surgical instrument such as a Kirschner wire, a cannulated drill bit or a screw adapted to act on the second vertebra of the patient 200 is inserted.

[0042] As can be seen from the attached figures, the longitudinal development axis 6a of the third guide member 6 is arranged transversely to the median plane X and to the longitudinal development axes 2a, 3a of the first guide member 2 and the second guide member 3.

[0043] The first guide member 2 and the second guide member 3 have longitudinal axes 2a and 3a that converge distally toward the medial plane X, where distal means the direction furthest from the patient's spine. In other words, the longitudinal axes 2a and 3a of the first guide member 2 and the second guide member 3 intersect above the intrinsic navigation guide 1 when considering the guide in its use configuration.

[0044] Furthermore, the longitudinal axes 2a and 3a of the first guide member 2 and the second guide member 3 are inclined in the caudal direction, i.e. towards the plate 8, and tend to intersect above the navigation guide when in the use configuration.

[0045] The longitudinal axis 2 a of the first guide member 2 and the longitudinal axis 3 a of the second guide member 3 are both inclined with respect to the longitudinal axis 6 a of the third guide member 6 .

[0046] The navigation guide 1 also comprises contact surfaces 14, 15, 16 designed to match corresponding contact areas 101, 102, 103 identifiable on the patient's first vertebra 100 and second vertebra 200 to define a single mating configuration of the navigation guide 1 specific to the respective vertebrae 100 and 200. In other words, these contact surfaces 14, 15 and 16 are patient specific and therefore follow the anatomical trends of the patient's vertebrae to which they are mated.

[0047] The combination of the inclination of the first guide member 2, second guide member 3 and third guide member 6 and the single connection of the guide 1 with the vertebrae 100, 200 via the above-mentioned contact surfaces 14, 15 and 16 provides accurate and unambiguous guidance of a surgical instrument inserted inside the channel 5 of the first guide member 2 or the second guide member 3, or inside the channel 7 of the third guide member 6, to identify an accurate and predetermined operating point.

[0048] In particular, contact surfaces 14, 15 and 16 are formed respectively underneath the first guide member 2 and the second guide member 3, as well as underneath the plate 8 connecting the third guide member 6 with either the first guide member 2 or the second guide member 3. The contact surface 16 located underneath the plate 8 also extends underneath the third guide member 6.

[0049] The vertebral contact areas 101, 102 and 103 each correspond to a surface of the first vertebra 100 lying laterally to the sacral apex or spinous process and one of the two lamina of the second vertebra 200 lying to the side of the sacral apex or spinous process.

[0050] In particular, the plate 8 defines on its proximal face, ie the surface in contact with the patient's vertebra, a contact surface 103 for contacting the lamina of the patient's vertebra.

[0051] The support frame 4 comprises a bridge 9 connecting the first guide member 2 and the second guide member 3. Said bridge 9 preferably has a substantially inverted V-shape.

[0052] Advantageously, the bridge 9 comprises a primary contact member 10 adapted to be coupled to the spinous process or sacral crest of the first vertebra 100 .

[0053] For easier handling, the bridge 9 includes a gripping element 17 substantially above the main contact organ 10, which can be attached to the spinous process or sacral crest, and the gripping element 17 also serves as a pressure point to maintain the guide in a stable position during insertion of a surgical instrument into the channel of the guide member.

[0054] The longitudinal axes 2a and 3a of the first 2 and second 3 guide members are inclined in the caudal direction, i.e. towards the plate 8, and tend to intersect above the gripping element 17 of the bridge 9 of the navigation guide.

[0055] Beneath the main contact member 10 of the bridge 9 is a notch 11 adapted to accommodate the sacral crest or spinous process. This notch 11 is not located in the center of the bridge 9, but is offset relative to the midpoint of the apex of the bridge 9 and is located near the sacral crest or spinous process. In one embodiment, the sacral crest or spinous process is accommodated inside the notch 11 and there is no contact between them. In another embodiment, the sacral crest or spinous process is accommodated inside the notch 11 and contacts the notch 11. In another embodiment, it is possible to form the notch 11 to be patient-specific and present an inner surface shaped to perfectly match the morphology of the patient's sacral crest or spinous process.

[0056] Advantageously, in a second aspect, the invention relates to a patient-specific navigation guide kit comprising two guides 1 as described above.

[0057] These guides 1 (designated 1' and 1'' in Figures 1-8) are substantially symmetrical to each other. In other words, both have the same structure including a support frame 4 to which a first guide member 2 and a second guide member 3 are connected. The support frame 4 has a bridge 9 with a notch 11, as described above.

[0058] Both guides 1', 1'' comprise, in addition to the first guide member 2' and the second guide member 3, only one additional third guide member 6. That is, the first guide 1' has this third guide member 6 connected only to the first guide member 2 via a plate 8, and the second guide 1'' has this guide member 6 connected only to the second guide member 3 via a plate 8. When considering the inherent navigation guides of the use configuration, both plates 8 extend in the caudal direction.

[0059] In this way, it is possible to first use the first guide and then, after properly removing the first guide, use the second guide to drill two sides of the second vertebra 200 that are substantially symmetrical with respect to the longitudinal line of the spinal column to which the two vertebrae 100 and 200 belong.

[0060] In use, the surgeon essentially makes an incision from the L05 vertebra to the S01 vertebra.

[0061] With this device it is possible not to extend the incision up to the S02 vertebra, even if the S02 vertebra is included in the surgical process.

[0062] By slightly expanding the wound with a finger, it is possible to first insert the first guide and act on the first vertebra (S01) 100 and the second vertebra (S02) 200 by inserting appropriate surgical instruments into the respective channels 5 and 7.

[0063] The first guide member 2 and the second guide member 3 act on the first vertebra 100 and can thus be joined together to the first vertebra 100 by apposition.

[0064] On the other hand, the third guide member 6 acts on a second vertebra 200 adjacent to the first vertebra and is then coupled thereto by apposition.

[0065] In other words, the guide members 2, 3 and 6 are not integrally constrained to the vertebrae but are only coupled thereto by contact.

[0066] Subsequently, the first guide 1 is removed, and taking into account that the first guide member 2 and the second guide member 3 of the two navigation guides coincide, the second guide can be inserted using the holes already drilled in the first vertebra (S01) 100, thus inserting the instruments already placed in the channels 5 of the first guide member 2 and the second guide member 3. The surgeon can thus operate on the second vertebra (S02) 200 on the opposite side to the median plane X, via the third guide member 6 of the second guide.

[0067] The invention thus created makes it possible to achieve the desired objectives.

[0068] Using the above navigation guide, sacral surgery can be performed in a minimally invasive manner due to the reduced dimensions of the equipment.

[0069] In fact, a single guide incorporates a hole for a surgical instrument adapted to act on the S01 vertebra and a third hole for inserting a surgical instrument to the right or left of the S02 vertebra.

[0070] The three guide members allow surgical instruments to be inserted with a minimally invasive technique, and the large support surfaces on the right side of one guide and on the left side of the other guide at the insertion side of the instruments into the S02 ensure greater stability during use.

[0071] Thus, the guide that is the subject of the present invention allows the surgeon to safely and precisely insert surgical instruments even along difficult trajectories, without continuous beam control.

[0072] Finally, the described guide allows for simplified placement relative to the patient's bony anatomy in a stable and safe manner. [Prior art documents] [Patent documents]

[0073] [Patent Document 1] EP2749235

Patent document 2

Patent Document 3

Claims

1. 1. A patient-specific navigation guide kit for use in spinal surgery, comprising: a first patient-specific navigation guide and a second patient-specific navigation guide, each of the first patient-specific navigation guide and the second patient-specific navigation guide comprising: a first guide member (2) integral with the support frame (4), the first guide member (2) extending from a proximal opening (2p) of the first guide member (2) to a distal opening (2d) of the first guide member (2) along a longitudinal axis of deployment (2a) of the first guide member (2), the first guide member (2) having an internal channel leading from the proximal opening (2p) of the first guide member (2) to the distal opening (2d) of the first guide member (2) along the longitudinal axis of deployment (2a) of the first guide member (2) for guiding a surgical instrument to a first vertebra (100) of a patient; a second guide member (3) integral with the support frame (4), the second guide member (3) extending from a proximal opening (3p) of the second guide member (3) to a distal opening (3d) of the second guide member (3) along a longitudinal axis of deployment (3a) of the second guide member (3), the second guide member (3) having an internal channel leading from the proximal opening (3p) of the second guide member (3) to the distal opening (3d) of the second guide member (3) along the longitudinal axis of deployment (3a) of the second guide member (3) for guiding a surgical instrument to the first vertebra (100) of the patient; and a patient-specific contact member (14, 15, 16) for positioning the patient-specific navigation guide along the patient's vertebrae (100, 200), the contact member (14, 15, 16) adapted to match corresponding contact areas (101, 102, 103) of the patient's first vertebra (100) and second vertebra (200); the plurality of contact areas (101, 102, 103) each corresponding to a surface of the first vertebra (100) of the patient that is located laterally to the sacral crest or spinous process and one of two lamina of the second vertebra (200) that is located on a lateral side of the sacral crest or spinous process; The first guide member (2) and the second guide member (3) are located symmetrically with respect to a median plane (X) passing between the first guide member (2) and the second guide member (3); each of the first patient-specific navigation guide and the second patient-specific navigation guide includes a third guide member (6) adapted to abut a second vertebra (200) adjacent and contiguous with the first vertebra (100) such that the first patient-specific navigation guide and the second patient-specific navigation guide each have only three guide members; the third guide member (6) of the first patient-specific navigation guide is integral with the support frame (4) of the first patient-specific navigation guide via a plate (8) connected only to the first guide member (2) of the first patient-specific navigation guide, and the third guide member (6) of the second patient-specific navigation guide is integral with the support frame (4) of the second patient-specific navigation guide via a plate (8) connected only to the second guide member (3) of the second patient-specific navigation guide; the third guide member (6) of the first patient-specific navigation guide and the third guide member (6) of the second patient-specific navigation guide are symmetrical with respect to the median plane (X) that separates the corresponding first guide member (2) and second guide member (3); a third guide member (6) of the first patient-specific navigation guide defining an axis that is inclined toward the median plane and that is incident on the first patient-specific navigation guide, and a third guide member (6) of the second patient-specific navigation guide defining an axis that is inclined toward the median plane and that is incident on the second patient-specific navigation guide.

2. A navigation guide kit as described in claim 1, wherein when the first patient-specific navigation guide is used on the patient, the plate (8) of the first patient-specific navigation guide extends in a caudal direction from the support frame (4) of the first patient-specific navigation guide, and when the second patient-specific navigation guide is used on the patient, the plate (8) of the second patient-specific navigation guide extends in a caudal direction from the support frame (4) of the second patient-specific navigation guide.

3. A navigation guide kit as described in claim 1 or 2, wherein the first guide member (2), the second guide member (3) and the third guide member (6) are tubular.

4. 4. The navigation guide kit of claim 1, wherein the third guide member (6) extends from a proximal opening (6p) of the third guide member (6) to a distal opening (6d) of the third guide member (6) along a longitudinal axis of deployment (6a) of the third guide member (6) for guiding a surgical instrument onto the adjacent second vertebra (200), and has an internal channel leading from the proximal opening (6p) of the third guide member (6) to the distal opening (6d) of the third guide member (6) along the longitudinal axis of deployment (6a) of the third guide member (6), the longitudinal axis of deployment (6a) of the third guide member (6) intersecting the median plane (X) and inclined with respect to the longitudinal axes of deployment (2a, 3a) of the first guide member (2) and the second guide member (3).

5. 2. The navigation guide kit of claim 1, wherein the plate (8) defines a contact surface (103) on its proximal surface (8p) configured for contacting the lamina of the second vertebra (200) of the patient in use.

6. 6. The navigation guide kit of claim 1, wherein the support frame (4) comprises a bridge (9) connecting the first guide member (2) and the second guide member (3), the bridge (9) comprising a main contact member (10) adapted to be coupled to the spinous process or sacral ridge (12) of the first vertebra (100).

7. The navigation guide kit of claim 6, wherein the bridge (9) comprises a gripping element (17) above the main contact member (10) that can be gripped by the surgeon.

8. 8. The navigation guide kit according to claim 6 or 7, wherein a notch (11) adapted to accommodate the sacral ridge is formed in the surface of the main contact member (10) of the bridge (9) facing the sacral ridge.

Images