System for vertebral implantation of a vertebral spacer element
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-03-26
- Publication Date
- 2026-04-08
Smart Images
Figure EP2024058052_05122024_PF_FP_ABST
Abstract
Description
[0001] Vertebral implantation system of a vertebral spacer element
[0002] Technical Field
[0003] The present invention relates to the technical field of systems allowing the implantation between two vertebrae of a vertebral spacer element. Such a vertebral spacer element, also called a spacer element or interspinous spacer, makes it possible to maintain a normal spacing between two adjacent vertebrae between which it is arranged. More precisely, the vertebral spacer element can be positioned between the spinous processes or between the laminae of two adjacent vertebrae. One interest is to combat degeneration of the intervertebral discs which can cause pain, numbness, weakness or even paralysis in various parts of the body.
[0004] This vertebral spacer element allows intervertebral spacing to be restored and thus loads to be distributed between the vertebrae and thus treated.
[0005] The present invention relates more specifically to systems for implanting elastically deformable and therefore flexible vertebral spacer elements. Implanting these types of vertebral spacer elements eliminates the steps of dissection of the muscle tissue and the supra- and interspinous ligaments, which are necessary when implanting hard or rigid, non-elastically deformable spacer elements. Their implantation is notably less invasive than that of rigid vertebral spacer elements.
[0006] Compared to rigid spacers, elastically deformable vertebral spacers further improve the mobility and flexibility of the spine, allowing for more natural movements, similar to those of a healthy spine.
[0007] Prior art
[0008] Systems for spinal implantation of elastically deformable vertebral spacers are known, such as that described in document ITFI20030292A1. The system described in this document comprises a tubing of square cross-section configured to receive a vertebral spacer element in a compressed state, via an opening formed at the proximal end of the tubing. The spacer element is then moved along the tubing, by means of a rod, until it is extracted from the tubing so as to be implanted between the spinous processes of a patient.
[0009] First, although not described in this document, placing the vertebral spacer element in the compressed state is not trivial and requires suitable tooling that is not described in this document. Indeed, the system described in this document does not allow the vertebral spacer element to be placed in a compressed state, so the operator must themselves compress the vertebral spacer element using a separate tool, for example by means of pliers. This step of compressing the vertebral spacer element requires a great deal of force. In addition, the vertebral spacer element may return to the deployed state accidentally, which would involve having to compress the vertebral spacer element again, could cause it to fall, or could injure the operator.
[0010] Furthermore, positioning the compressed vertebral spacer element in the tubing is particularly complex. To position the spacer element inside the tubing, it must be possible to keep it in a compressed state during its introduction, via the proximal opening of the tubing, which requires a great deal of precision and is very complicated. This requires, in particular, complex manipulations to prevent the vertebral spacer element from accidentally deploying when trying to introduce it through the opening of the tubing.
[0011] Furthermore, the system described in this document provides for the implantation of the spacer element via a large-section cannula, which is not suitable for the implementation of a so-called minimally invasive implantation technique (MISS for Minimally Invasive Spine Surgery). Indeed, such a minimally invasive technique provides for the use of a small-diameter tube or trocar, generally less than 16 millimeters, allowing the passage and delivery of the spacer element to between the vertebrae. According to this minimally invasive technique, the trocar allows the passage of the spacer element to be framed to the area to be treated so that the spacer element does not damage tissue during its implantation.
[0012] Neither the system described in this prior art document nor any other known prior art document provides a solution for enabling a vertebral spacer element to be placed in a small diameter trocar suitable for minimally invasive implantation. The minimally invasive technique is therefore not yet used to date for the implantation of vertebral spacers.
[0013] Statement of the invention
[0014] An aim of the present invention is to propose a system for vertebral implantation of a vertebral spacer element which overcomes the aforementioned drawbacks.
[0015] To this end, the invention relates to a system for vertebral implantation of a vertebral spacer element at least partially elastically deformable between a deployed state and a compressed state, the implantation system comprising: a compression device having a housing intended to receive the vertebral spacer element in the deployed state, the compression device being configured to exert a compressive force on said vertebral spacer element located in said housing so as to cause said vertebral spacer element to pass from the deployed state to the compressed state; a guide device having an open distal end and comprising an implantation tube, the guide device being connectable to said compression device;and a pushing device configured to cooperate: with the compression device, when the guide device is connected thereto, to push the vertebral spacer element in the compressed state from the housing of the compression device into the implantation tube of the guide device; and with the guide device to push the vertebral spacer element in the compressed state along the implantation tube to the distal end of the guide device, so as to extract said vertebral spacer element from the guide device.;
[0016] The deployed state of the vertebral spacer element corresponds to a resting state in which it is not compressed. Compressing the vertebral spacer element makes it possible to reduce its size in order to allow its introduction between two vertebrae. The compressed state corresponds to a state of introduction of the vertebral spacer element. In the compressed state, the vertebral spacer element has a reduced size in at least one direction, preferably a reduced height, facilitating its introduction into the guide device in particular.
[0017] Compression means a rectilinear pressure force exerted on the spacer element. This compression advantageously constitutes a crushing of the spacer element.
[0018] The vertebral spacer element is flexible. It tends to return to the deployed state when compressed. Also, when positioned between two vertebrae it tends to return to the deployed state.
[0019] The vertebral implantation system according to the invention is particularly suitable for the implantation of an elastically deformable vertebral spacer element such as that described in EP 4 149 376 A1 or in US 8 118 839 B2. The vertebral spacer element advantageously has at least one wing, preferably two wings, elastically deformable.
[0020] Advantageously, the vertebral implantation system is suitable for carrying out the vertebral implantation of a vertebral spacer element such as that described in EP 4 149 376 A1 and the description of which is incorporated in the present text.
[0021] The vertebral spacer element advantageously extends in a main direction. It is advantageously deformable in at least one direction transverse to its main direction.
[0022] In a non-limiting manner, the housing of the compression device may be cylindrical in shape. The housing advantageously has a longitudinal direction.
[0023] The compression device advantageously has a receiving position in which it is configured to receive the vertebral spacer element in the deployed state, within the housing. The compression device advantageously has a compression position in which it compresses the vertebral spacer element.
[0024] The transverse dimensions of the housing, considered transversely to the longitudinal direction of the housing, when the compression device is in the receiving position are greater than said transverse dimensions when the compression device is in the compression position. In other words, the section of the housing is reduced when the compression device is brought into the compression position.
[0025] Preferably, the housing has the shape of a tube when the compression device is in the compression position. Preferably, the diameter of this tube is less than or equal to the diameter of the implantation tube.
[0026] Preferably, the compression device is configured to bring the vertebral spacer element into the compressed state by reducing the dimensions of the housing in at least one direction, preferably in a direction transverse to the longitudinal direction of said housing. Preferably, the compression device allows the vertebral spacer element to be compressed radially.
[0027] When in the compressed state, the vertebral spacer element may be disposed in the implantation tube of the guide device. More specifically, when in the compressed state, the transverse dimensions of the vertebral spacer element, considered transverse to its main direction, are less than the diameter of the implantation tube.
[0028] By virtue of the invention, the compression device makes it possible to effectively compress the vertebral spacer element and to easily bring it from the deployed state to the compressed state when actuated. The effort required to bring the vertebral spacer element into the compressed state is therefore reduced. The invention makes it possible to dispense with the use of a separate and unsuitable tool, such as pliers, to put the vertebral spacer element into the compressed state.
[0029] The compression device makes it possible in particular to compress the vertebral spacer element sufficiently to allow its introduction into a guiding device of small section or small external diameter, generally between 12 and 16 millimeters, which can be used for the implementation of a minimally invasive implantation technique. The vertebral implantation system according to the invention is therefore suitable for carrying out a minimally invasive implantation.
[0030] The compression device preferably comprises a press.
[0031] The guiding device is configured to guide the vertebral spacer element to between two vertebrae and thus allow its implantation. It advantageously has a generally cylindrical shape, with a circular section. The guiding device advantageously has a reduced external diameter compared to the tubing of the devices of the prior art, thus allowing its use in the context of a minimally invasive technique. The guiding device preferably has an external diameter, at least at its distal end, of less than 20 millimeters, preferably less than 16 millimeters, more preferably between 12 and 16 millimeters.
[0032] The implantation tube is formed in the guide device. The implantation tube has a circular cross-section. The implantation tube advantageously has a constant cross-section. The implantation tube is configured to receive the vertebral spacer element in the compressed state and to guide the translational movement of the vertebral spacer element to the distal end of the guide device. In other words, the implantation tube forms a conduit for receiving the vertebral spacer element in the compressed state. The implantation tube advantageously extends along a guide axis.
[0033] The distal end of the guide device advantageously has a distal opening. The distal opening is advantageously an axial opening. The distal opening formed in the distal end of the guide device opens into the implantation tube.
[0034] The guide device advantageously comprises a proximal end in which a proximal opening is formed for the introduction of the vertebral spacer element into the implantation tube. Said proximal opening opens into the implantation tube. The proximal opening is advantageously an axial opening considered along the guide axis of the guide device. The proximal end of the guide device is advantageously configured to be connected to said compression device.
[0035] Preferably, the guide device is configured to be removably connected to the compression device.
[0036] Preferably, the connection of the guide device to the compression device makes it possible to secure said guide device and said compression device. In other words, when the guide device is connected to the compression device, said guide device is advantageously secured to the compression device.
[0037] The implantation tube preferably defines a channel for receiving the vertebral spacer element in the compressed state.
[0038] The implantation tube advantageously has a diameter equal to or slightly greater than the transverse dimensions of the vertebral spacer element in the compressed state, so that the vertebral spacer element is maintained in the compressed state when it is arranged in said implantation tube. The implantation tube advantageously has a diameter between 10 millimeters and 14 millimeters. The diameter of the implantation tube corresponds to an inner diameter of the guide device.
[0039] Without limitation, when the vertebral spacer element is in the deployed state, it has at least one dimension, preferably a height, greater than the diameter of the implantation tube, such that it cannot be introduced into the implantation tube.
[0040] In a non-limiting manner, the guide device may comprise only a single part, in which case the implantation tube advantageously comprises a single portion of tube formed in said single part.
[0041] Alternatively, and without departing from the scope of the invention, the guide device may comprise a plurality of parts which can be assembled together, in which case the implantation tube advantageously comprises a plurality of tube portions, each being formed in one of said parts.
[0042] The pushing device of the implantation system according to the invention is configured to exert a pushing force on the vertebral spacer element in a pushing direction. It is configured to be brought into successive cooperation with the pushing device and the guiding device.
[0043] Preferably, said thrust direction coincides with the longitudinal direction of the housing of the compression device when the thrust device cooperates with the compression device. Preferably, the thrust direction coincides with the guide axis of the implantation tube of the guide device when the thrust device cooperates with the guide device.
[0044] Preferably, the pushing device is configured to be removably connected to the compression device. Preferably, the pushing device is configured to be removably connected to the guide device. Preferably, the connection of the pushing device to the compression device makes it possible to secure said pushing device and said compression device. In a non-limiting manner, the vertebral implantation of the vertebral spacer element by means of the vertebral implantation system according to the invention can be carried out as follows.
[0045] First, the vertebral spacer element in the deployed state is positioned in the housing of the compression device. The compression device is then actuated so as to compress the vertebral spacer element and bring the latter into the compressed state. In the compressed state, the vertebral spacer element has dimensions transverse to its main direction smaller than the diameter of the implantation tube and can therefore be introduced into the latter.
[0046] The thrust device is put in cooperation with the compression device. The thrust direction is then substantially coincident with the longitudinal direction of the housing.
[0047] The guide device is also connected to the compression device so that the implantation tube extends in line with the housing of the compression device. The guide device is then attached to the compression device. The longitudinal direction of the housing of the compression device and the guide axis of the guide device are then substantially coincident. The housing of the compression device then opens into the implantation tube.
[0048] When cooperating with the compression device, the guide device and the pushing device preferably extend on either side of the compression device.
[0049] When the guide device and the pushing device cooperate with the compression device, the pushing direction of the pushing device and the guide axis of the implantation tube are preferably substantially coincident.
[0050] In a non-limiting manner, the actuation of the compression device can be carried out after the compression device has been brought into cooperation with the thrust device and / or with the guide device.
[0051] Preferably, the housing of the compression device, when the latter is actuated, has a section substantially equal to or slightly smaller than the section of the implantation tube.
[0052] The thrust device is then actuated, which exerts a thrust force on the vertebral spacer element in the thrust direction, directed towards the implantation tube of the guide device. The vertebral spacer element is then moved in translation from the housing of the compression device to the interior of the implantation tube of the guide device. The vertebral spacer element passes through the proximal opening formed in the proximal end of the guide device. It is understood that the vertebral spacer element is brought inside the implantation tube, and therefore the guide device, close to the proximal end of the guide device.
[0053] The vertebral spacer element is advantageously moved in the longitudinal direction of the housing.
[0054] When passing from the compression device housing into the implantation tube, the vertebral spacer element is maintained in the compressed state.
[0055] According to the invention, the pushing device makes it possible to transfer the vertebral spacer element from the compression device to the inside of the implantation tube. Thanks to the invention, the vertebral spacer element is maintained in the compressed state during this transfer and does not risk accidentally deploying. In other words, the vertebral implantation system makes it possible to facilitate the compression of the vertebral spacer element as well as its positioning, in the compressed state, inside the implantation tube of the guide device. The invention therefore makes it possible to avoid complex manipulations for arranging the vertebral spacer element in the compressed state in the guide device. The introduction of the vertebral spacer element into the guide device and more generally its implantation are therefore facilitated.
[0056] The pushing device is then brought into cooperation with the guiding device, preferably connected to the guiding device. Preferably, the pushing device is brought into cooperation with the proximal end of the guiding device.
[0057] The pushing device is then actuated so as to exert a pushing force on the vertebral spacer element, which is moved in translation along the implantation tube. The vertebral spacer element is moved in translation along the guide axis of the implantation tube. The pushing device is configured to move the vertebral spacer element from the proximal end to the distal end of the guide device. The vertebral spacer element is maintained in the compressed state throughout its movement in the implantation tube. It is brought to the open distal end of the guide device where it is extracted from the guide device in order to be arranged between two successive vertebrae where it returns to its deployed state and is implanted.
[0058] Furthermore, the guidance device of the implantation system according to the invention makes it possible to control the passage of the vertebral spacer element to the area to be treated so that the vertebral spacer element does not damage tissue during its implantation.
[0059] Advantageously, the guide device has a proximal end, opposite said distal end, configured to be connected to the compression device or to the pushing device. The guide device can therefore be alternatively connected to the pushing device or to the compression device.
[0060] One advantage is that it allows the compression device and the guide device to be kept together to prevent them from separating. This allows the vertebral spacer element to be brought directly from the compression device into the guide device, without the risk of it being deployed. Another advantage is that it allows the vertebral spacer element to be brought into the guide device only by actuating the pushing device, without it being necessary to hold the pushing device and the compression device manually, and in particular to position them correctly relative to each other, when actuating the pushing device.
[0061] Another advantage is that it allows the pushing device and the guiding device to be kept together. This again allows the vertebral spacer element to be moved along the implantation tube without the need to manually hold the pushing device and the guiding device and to position them correctly relative to each other when actuating the pushing device. This makes it easier to deliver the vertebral spacer element to the distal end of the guiding tube.
[0062] Preferably, the guide device comprises a first connector portion, the compression device comprises a second connector portion configured to cooperate with the first connector portion for connecting the guide device to the compression device, and the pushing device comprises a third connector portion configured to cooperate with the first connector portion for connecting the guide device to the pushing device.
[0063] It is understood that the guide device can be easily connected or disconnected relative to the compression device and the pushing device. The first and second connector portions allow the relative translational movement of the guide device to be blocked relative to the compression device. The first and third connector portions allow the relative translational movement of the guide device to be blocked relative to the pushing device.
[0064] Advantageously, the first connector portion and at least one of said second and third connector portions comprise complementary bayonet connection portions. Complementary bayonet connection portions are understood to mean at least one female bayonet connection portion and at least one male bayonet connection portion. One advantage is to allow quick and easy connection and / or disconnection of the guide device to the pushing device or to the compression device. A male bayonet connection portion advantageously comprises at least one pin. A female bayonet connection portion advantageously comprises a notch formed in the corresponding device.
[0065] Preferably, the first connector portion comprises at least one female bayonet connection portion while the second connector portion and / or the third connector portion comprises at least one male bayonet connection portion. Alternatively, the first connector portion comprises at least one male bayonet connection portion while the second connector portion and / or the third connector portion comprises at least one female bayonet connection portion.
[0066] According to another advantageous variant, the first connector portion comprises a collar formed at the proximal end of the guide device or a locking ring located at the proximal end of the guide device, and at least one of the second and third connector portions comprises a locking ring configured to cooperate with said collar, respectively a collar configured to cooperate with said locking ring, for the connection of the guide device to the compression device or to the pushing device.
[0067] The locking ring advantageously has a pivoting ring portion that can be opened or closed. In this closed position, the locking ring is configured to grip the collar to block the relative translational movement of the two connector portions.
[0068] Preferably, said guide device comprises: a transfer cartridge comprising a first tube portion and being configured to be connected to the compression device; and a guide tubing configured to be connected to said transfer cartridge and comprising a second tube portion, said first and second tube portions defining said implantation tube, the pushing device being configured to cooperate: with the compression device, when the transfer cartridge is connected thereto, to push the vertebral spacer element in the compressed state from the housing of the compression device into the first tube portion of the transfer cartridge;and with said transfer cartridge, when the guide tubing is connected thereto, to push the vertebral spacer element in the compressed state from inside the first tube portion to the distal end of the guide device via inside the second tube portion, so as to extract said vertebral spacer element from the guide device.;
[0069] In this non-limiting embodiment, the guide device comprises two separate parts. The transfer cartridge advantageously has the shape of a cylinder of circular section. The guide tube advantageously has a cylindrical shape, more preferably of circular section. The first tube portion advantageously extends along a cartridge axis. The second tube portion advantageously extends along a tube axis.
[0070] Preferably, the transfer cartridge has a first end configured to be connected to the compression device and / or the pushing device. This first end corresponds to the proximal end of the guiding device. Preferably, the transfer cartridge has a second end, opposite the first end, configured to be connected to the guiding tubing.
[0071] Preferably, the guide tubing has a first end portion configured to be connected to the transfer cartridge and a second end portion opposite the first end portion. This second end portion corresponds to the distal end of the guide device.
[0072] When the transfer cartridge is connected to the compression device, said first tube portion extends in the extension of the housing of the compression device. In addition, the cartridge axis is then advantageously coincident with the longitudinal direction of the housing. When the guide tube is connected to the transfer cartridge, said second tube portion extends in the extension of the first tube portion. In addition, the tube axis and the cartridge axis are then advantageously coincident. In addition, the tube axis and the cartridge axis are then advantageously coincident with the guide axis of the implantation tube of the guide device.
[0073] Preferably, the second tube portion has a diameter substantially equal, preferably equal, to the diameter of the first tube portion.
[0074] The guide tube allows the implantation of the vertebral spacer element and its second end part is intended to be positioned close to the patient's vertebrae.
[0075] To proceed with the implantation of the vertebral spacer element, the transfer cartridge is first connected to the compression device and the pushing device is actuated so as to push the vertebral spacer element inside the first tube portion, and thus inside the transfer cartridge.
[0076] The transfer cartridge is then disconnected from the compression device and connected to the guide tubing and brought into cooperation with the pushing device. The pushing device then moves the vertebral spacer element from inside the first tube portion of the transfer cartridge to inside the second tube portion of the guide tubing, and then to the distal end of the guide device.
[0077] In this configuration, the transfer cartridge provides a buffer receptacle for temporarily holding the vertebral spacer element in a compressed state before it is positioned in the guide tube. The use of a transfer cartridge eliminates the need to connect the guide tube to the compression device when transferring the vertebral spacer element between the compression device and the guide device. The guide tube can be kept close to the implantation area and the risk of contamination of the guide tube is therefore reduced.
[0078] Alternatively, without departing from the scope of the invention, the guide tubing may be kept connected to the transfer cartridge when the vertebral spacer element is brought from the housing of the compression device into said transfer cartridge.
[0079] Preferably, the transfer cartridge is configured to be connected to the pushing device.
[0080] Preferably, said transfer cartridge has a length less than half the length of the guide tube. Preferably, the length of the transfer cartridge is substantially equal to or slightly greater than the length of a vertebral spacer element to be implanted. One advantage is to reduce the size of the guide device.
[0081] Advantageously, said guide tube is configured to be connected to said transfer cartridge via a bayonet connection or via a clamping ring configured to cooperate with a collar. An advantage is to allow the guide tube and the transfer cartridge to be easily and quickly connected and disconnected.
[0082] Preferably, the transfer cartridge comprises at least one female bayonet connection portion and the guide tubing comprises at least one male bayonet connection portion, for example a pin extending radially inside the guide tubing.
[0083] Advantageously, said guide tube comprises a tubular gripping portion and a tubular body connected to said tubular gripping portion, said tubular gripping portion having an outside diameter greater than an outside diameter of the tubular body. An advantage is to facilitate the handling of the guide tube and more generally of the guide device. Said gripping portion advantageously extends between the transfer cartridge and the tubular body.
[0084] Preferably, the compression device comprises a lower jaw, an upper jaw and a clamping member configured to move said upper and lower jaws towards or away from each other. Actuation of the clamping member allows the upper and lower jaws to be moved towards or away from each other. The bringing together of the jaws has the effect of compressing the vertebral spacer element positioned in the housing. The housing is formed between the two jaws. Such a compression device makes it possible to effectively compress the vertebral spacer element while reducing the effort required by the operator.
[0085] Preferably, only one of the two jaws is movable in translation while the other jaw is fixed. More preferably, only the upper jaw is movable. The clamping member advantageously allows the upper jaw to be moved relative to the lower jaw. Preferably, the upper jaw is movable in translation relative to the lower jaw. The clamping member advantageously allows the upper jaw to be moved along a clamping axis.
[0086] When the compression device is in the compression position, the upper and lower jaws are advantageously in contact.
[0087] The clamping member advantageously comprises a threaded rod and a clamping wheel.
[0088] Preferably, the housing of the compression device is cylindrical in shape. The compression device is advantageously capable of taking a compression position in which the housing is cylindrical in shape with a circular cross-section.
[0089] Preferably, a first semi-cylindrical groove is formed in the lower jaw, a second semi-cylindrical groove is formed in the upper jaw, said first and second semi-cylindrical grooves together defining said housing of said compression device. An interest is to effectively maintain the vertebral spacer element in the compressed state in the housing, preventing it from being able to be extracted radially from the housing of the compression device.
[0090] Preferably, the thrust device comprises a main body, a piston and a trigger configured to cause the piston to translate relative to the main body when actuated.
[0091] The pushing device advantageously has the form of a gun, of the extruder gun type.
[0092] The piston is configured to exert a thrust force on the vertebral spacer element in the compressed state. The piston advantageously extends in the thrust direction of the thrust device.
[0093] Advantageously, the piston comprises a rod and a piston head, said piston head having a diameter smaller than the diameter of the implantation tube of the guide device. An advantage is to allow the piston to penetrate inside the implantation tube of the guide device in order to be able to effectively push the vertebral spacer element to the distal end of the guide device.
[0094] Preferably, the length of the piston rod is greater than or equal to the length of the guide device. Preferably, the piston head has a diameter smaller than the diameter of the housing of the compression device when the latter is in the compression position. An advantage is to allow the piston to penetrate into the housing.
[0095] Advantageously, the distal end of the guide device is at least partially beveled. One advantage is to facilitate the positioning of the distal end of the guide device as close as possible to the implantation area of the vertebral spacer element.
[0096] Advantageously, the distal end of the guide device comprises a domed engagement portion. This engagement portion is configured to bear on one of the vertebrae at the implantation zone and prevents damage to the tissues, ligaments and bones.
[0097] Preferably, the engagement portion has the shape of a quarter sphere.
[0098] Brief description of the drawings
[0099] The invention will be better understood on reading the following description of an embodiment of the invention given by way of non-limiting example, with reference to the appended drawings, in which:
[0100] [Fig. 1]Figure 1 shows a guiding device of a vertebral implantation system according to the invention;
[0101] [Fig. 2] Figure 2 shows the transfer cartridge of the guide device of Figure 1;
[0102] [Fig. 3]Figure 3 is a first perspective view of the guide tubing of the guide device of Figure 1;
[0103] [Fig. 4]Figure 4 is a second perspective view of the guide tubing of the guide device of Figure 1;
[0104] [Fig.5]Figure 5 shows the compression device of the spinal implantation system according to the invention;
[0105] [Fig. 6]Figure 6 shows the pushing device of the vertebral implantation system according to the invention; [Fig. 7]Figure 7 shows the introduction of a vertebral spacer element into the housing of the compression device of Figure 5;
[0106] [Fig. 8]Figure 8 shows the compression of the vertebral spacer element using the compression device of Figure 5;
[0107] [Fig. 9]Figure 9 shows the vertebral spacer element pushed into the transfer cartridge using the pushing device of Figure 6;
[0108] [Fig. 10]Figure 10 shows the vertebral spacer element in the compressed state arranged in the transfer cartridge;
[0109] [Fig. 1 l]Figure 11 shows the vertebral spacer element pushed along the implantation tube;
[0110] [Fig. 12]Figure 12 shows the extraction of the vertebral spacer element from the guide device; and
[0111] [Fig. 13]Figure 13 shows the implantation of the vertebral spacer element between two vertebrae using the vertebral implantation system according to the invention. Description of the embodiments
[0112] The invention relates to a system for vertebral implantation of a vertebral spacer element making it possible to implant such a vertebral spacer element in particular between two successive vertebrae.
[0113] A non-limiting embodiment of such a vertebral implantation system 10 according to the invention will be described with reference to Figures 1 to 13.
[0114] According to the invention, the vertebral implantation system 10 comprises a guiding device 20, a compression device 40 and a pushing device 60.
[0115] Figure 1 illustrates a guide device 20 of the vertebral implantation system 10 according to the invention. The guide device 20 has a generally cylindrical shape, with a circular section. It has an open proximal end 20a and a distal end 20b which is also open. The distal end 20b of the guide device is beveled. The guide device 20 extends along a guide axis X.
[0116] In this non-limiting example, the guide device 20 comprises a transfer cartridge 22 of tubular shape illustrated in FIG. 2. The transfer cartridge 22 has a first end 22a, constituting said proximal end 20a of the guide device 20, and a second end 22b. The transfer cartridge 22 comprises a first tube portion 24. The first tube portion 24 forms a conduit inside the transfer cartridge 22. A proximal opening 25 is provided axially in said transfer cartridge 22 and opens into said first tube portion 24. The transfer cartridge 22 and the first tube portion 24 extend along a cartridge axis X. x .
[0117] The guide device 20, and more precisely the first end 22a of the transfer cartridge 22, comprises three female bayonet connection portions together forming a first connector portion 23 for the guide device. The second end 22b of the transfer cartridge 22 also comprises three female bayonet connection portions 27.
[0118] The guide device 20 further comprises a guide tube 26 of generally cylindrical shape, of circular section, illustrated in figures 3 and 4. The guide tube 26 extends along a tube axis X2. The guide tube 26 has a first end portion 26a and a second end portion 26b, corresponding to the distal end 20b of the guide device 20.
[0119] As illustrated in Figure 1, said transfer cartridge 22 has a length I less than half the length L of the guide tube 26.
[0120] A distal opening 29 is provided axially in the second end portion 26b of the guide tube 26. Furthermore, as can be seen in FIG. 3, the second end portion 26b of the guide tube 26, and therefore the distal end 20b of the guide device 20, comprise a domed engagement portion 28. The guide tube 26 comprises a tubular gripping portion 30 and a tubular body 32 connected to said gripping portion 30 and extending in the extension of the gripping portion. The body 32 and said gripping portion 30 extend along the tube axis X2. The gripping portion 30 has an outside diameter greater than an outside diameter of the body 32. The gripping portion 30 comprises indentations 31 facilitating the handling of the guide device.
[0121] The guide tube 26 comprises a second tube portion 34 extending along the tube axis X2. The second tube portion 34 forms a conduit inside the guide tube. The diameter of the second tube portion 34 is substantially equal to the diameter of the first tube portion 24. The diameter of the second tube portion 34 corresponds to the internal diameter of the guide tube 26.
[0122] Referring to Figure 4, it can be seen that the first end portion 26a of the guide tube 26 comprises three connection pins 33 extending radially inwardly of the guide tube 26. These connection pins 33 form male bayonet connection portions. The connection pins 33 are configured to engage with the bayonet connection portions 27 of the second end 22b of the transfer cartridge 22, for the releasable connection of the guide tube 26 to the transfer cartridge 22.
[0123] Referring again to Figure 1, it can be seen that when the transfer cartridge 22 is connected to the guide tube 26, the cartridge axis X2 and the tube axis X2 coincide with each other and coincide with the guide axis X of the guide device. The guide device 20 comprises an implantation tube 36 defined by the first and second tube portions 24, 34. In this non-limiting example, said first and second tube portions 24, 34 form the implantation tube 36. The implantation tube 36 defines a conduit inside the guide device 20. The implantation tube extends along the guide axis X. The implantation tube 36 has a diameter constituting an inside diameter for the guide device 20.
[0124] Figure 5 illustrates a compression device 40 of the spinal implantation system 10 according to the invention. The compression device 40 comprises a press. The compression device 40 comprises a lower jaw 42 and an upper jaw 44 disposed above the lower jaw 42.
[0125] A first semi-cylindrical groove 43 is formed in the lower jaw 42 while a second semi-cylindrical groove 45 is formed in the upper jaw 44. The first and second grooves together form a cylindrical housing 46. The housing 46 extends in a longitudinal direction L illustrated in FIG. 7.
[0126] The lower jaw 42 is mounted on a support 47. The compression device 40 comprises four guide rods 48 fixed to the lower jaw 42 and projecting transversely to said lower jaw, vertically. The guide rods 48 extend parallel to each other. A mounting part 50 is fixed to the upper ends of the guide rods 48. The upper jaw 44 is mounted movable in translation along the guide rods 48 along a clamping axis Z which is here vertical. It is further locked in rotation. The compression device 40 further comprises a clamping member 52 configured to move the upper jaw 44 relative to the lower jaw 42 along said clamping axis Z. The clamping member 52 extends along the clamping axis Z. In this non-limiting example, the clamping member 52 comprises a clamping wheel 54 connected to a threaded rod 56 cooperating with a tapping formed in the upper jaw 44.
[0127] The clamping member is locked in translation relative to the mounting part 50 and is in helical sliding connection with the upper jaw 44. When the clamping member 52 is pivoted about its axis, it drives the upper jaw 44 in translation along the guide rods 48. By actuating the clamping member 52, the upper jaw can therefore be brought closer to the lower jaw 42, in order to reduce the size of the housing 46. When the upper and lower jaws 42, 44 are brought into contact, the housing has a circular cylindrical shape. The upper jaw 44 can also be moved away from the lower jaw 42, so as to increase the size of the housing 46.
[0128] As can be seen in Figure 7, the compression device 40 further comprises three connection pins 57 together forming a second connector portion 58 of the male bayonet connector type. These connection pins 57 of the second connector portion 58 are configured to cooperate with the female bayonet connection portions of the first connector portion 23 of the guide device 20 for the connection of the guide device to the compression device 40, in a removable manner.
[0129] As illustrated in Figure 6, the vertebral implantation system 10 further comprises a pushing device 60 having the shape of an extruder gun. The pushing device 60 comprises a main body 62 comprising a handle 63 and a cylindrical portion 64 extending in a pushing direction Y. The pushing device 60 further comprises a piston 66 mounted to move in translation relative to the main body 62 in the pushing direction Y. More specifically, the piston 66 comprises a piston rod 67 and a piston head 68 fixed to the end of the piston rod 67. The piston rod 67 is mounted to move in translation inside the cylindrical portion 64 of the main body 62, in the pushing direction Y. The piston rod 67 passes through said cylindrical portion 64. The pushing device 60 further comprises a trigger 70 pivotally mounted relative to the main body 62.The trigger is configured to cause the piston 66 to move in translation relative to the main body, in the thrust direction Y, when it is actuated.
[0130] The cylindrical portion 64 of the main body 62 of the thrust device 60 further comprises three connection pins 69 projecting radially inside said cylindrical portion. The connection pins 69 form a third connector portion 69. These connection pins constitute male bayonet connection portions.
[0131] The implantation of a vertebral spacer element 100 by means of the vertebral implantation system 10 according to the invention will now be detailed with reference to figures 7 to 11.
[0132] First, a vertebral spacer element 100 is provided that is elastically deformable between a deployed state and a compressed state. In this non-limiting example, a vertebral spacer element 100 is provided such as that described in document EP 4 149 376 A1. The vertebral spacer element 100 here comprises two wings 102, 104 that are elastically deformable and can be compressed in order to reduce the height H thereof. The vertebral spacer element extends in a main direction.
[0133] As can be seen in Figure 7, the compression device 40 is first placed in a receiving position in which its upper and lower jaws 44, 42 are spaced apart from each other. The size of the housing 46 is then sufficient to receive the vertebral spacer element 100 in the deployed state.
[0134] The vertebral spacer element 100 is then introduced into the housing 46 of the compression device 40, between the lower 42 and upper 44 jaws. The vertebral spacer element 100 is in the deployed state, forming a rest state in which the height H of its wings 102, 104 is maximum. In this deployed state, the vertebral spacer element 100 cannot be introduced into the implantation tube 36 of the guide device 20, since the height H of its wings is greater than the diameter of the implantation tube 36.
[0135] The clamping member 52 is then actuated by pivoting the clamping wheel 54 clockwise. As a result, the upper jaw 44 is moved in translation along the rods 48 and is brought closer to the lower jaw 42. The size of the housing 46 is reduced and the jaws exert a compressive force on the vertebral spacing element 100 and in particular on the wings 102, 104, which has the consequence of reducing the height H of the wings and therefore more generally of the vertebral spacing element 100.
[0136] As illustrated in Figure 8, when the upper and lower jaws 44, 42 are brought together as closely as possible and come into contact, the size of the housing 46 is reduced to a minimum and the compression device 40 is then in a compression position. The housing 46 then has a tubular shape and has a diameter d substantially equal to or slightly less than the diameter D of the implantation tube 36. Taking into account the compression force exerted by the compression device, the vertebral spacer element 100 is then placed in the compressed state and the height h of its wings is then reduced. The height of the wings of the vertebral spacer element 100 and more generally of the vertebral spacer element is then less than the diameter of the implantation tube 36.
[0137] The compression device 40 of the vertebral implantation system 10 according to the invention therefore makes it possible to reduce the transverse dimensions and in particular the height of the vertebral spacer element 100 in order to then allow its introduction into the guide device 20. This compression device 40 also makes it possible to strongly compress the vertebral spacer element in order to be able to place it in an implantation tube of reduced diameter, which allows the use of a guide device 20 with small internal and external diameters, compatible with a minimally invasive vertebral implantation technique (MISS).
[0138] The diameter of the housing 46 when the compression device 40 is in this compression position is slightly greater than the diameter of the piston head 68 of the piston 66 of the thrust device 60. The upper 44 and lower 42 jaws then define a first face 40a and a second face 40b, opposite the first face, for the compression device 40.
[0139] As can be seen in Figure 9, the thrust device 60 is then brought into cooperation with the compression device 40. The piston 66 is placed opposite the housing 46 and the thrust device 60 is positioned so that the thrust direction Y is substantially coincident with the longitudinal direction L of the housing 46. The thrust device 60 is positioned so that the cylindrical portion 64 of the main body 62 comes into contact with the first face 40a of the compression device.
[0140] In addition, the first connector portion 23 of the guide device 20 and of the transfer cartridge 22 is brought into cooperation with the second connector portion 58 of the compression device 40. Said transfer cartridge 22 is thus connected to the compression device 40. The first tube portion 24 formed in the transfer cartridge 22 then extends in the extension of the housing 46. Furthermore, the cartridge axis XI is then substantially coincident with the longitudinal direction L of the housing 46.
[0141] The pushing device 60 is then actuated by pivoting the trigger 70. The piston 66 is moved in translation in the pushing direction Y and pushes the vertebral spacer element 100 in said pushing direction. Since the diameter of the piston head is less than the diameter of the housing 46, the piston jointly penetrates into the housing 46. Taking into account the pushing force exerted by the piston 66, the vertebral spacer element 100 is moved to the inside of the first tube portion 24, and therefore inside the implantation tube 36 and the guide device 20. The vertebral spacer element 100 passes directly from the inside of the housing 46 to the inside of the first tube portion 24 of the transfer cartridge 22, and is maintained in the compressed state.
[0142] Thanks to the invention, the introduction of the vertebral spacer element into the guide device 20 is particularly facilitated and the vertebral spacer element 100 does not risk deploying when it is brought into the guide device.
[0143] The vertebral spacer element 100 is brought entirely inside the transfer cartridge 22, in the first tube portion 24, as illustrated in FIG. 10. The transfer cartridge can then be disconnected from the compression device, the vertebral spacer element 100 being held inside said transfer cartridge 22, in the compressed state.
[0144] As illustrated in Figure 11, the guide tubing 26 and the pushing device 60 are then connected to the transfer cartridge 22.
[0145] The transfer cartridge 22 is connected to the guide tube 26 by means of the bayonet connection portions. The guide tube 26 and the transfer cartridge 22 then extend along the guide axis X of the guide device 20, in line with one another. The transfer cartridge 22 and the guide tube 26 are thus secured. The first and second tube portions 24, 34 then together define the implantation tube 36. In addition, the pushing device 60 is brought into cooperation with the transfer cartridge 22. More precisely, the pushing device 60 is removably connected to the transfer cartridge 22. To do this, the connection pins 69 of the cylindrical portion 64 of the pushing device 60 are brought into cooperation with the female bayonet connection portions 23 of the transfer cartridge 22.In other words, the third connector portion 69 is brought into cooperation with the first connector portion 23.
[0146] Therefore, the thrust direction Y is substantially the same as the guide axis X of the guide device 20.
[0147] The pushing device 60 is then actuated, so that the piston 66 pushes the vertebral spacer element 100, in the compressed state, along the implantation tube 36 and thus along the guide device 20, along the guide axis X. The vertebral spacer element 100 is moved from the proximal end 20a to the distal end 20b of the guide device 20. The vertebral spacer element passes from the interior of the transfer cartridge 22 to the interior of the guide tubing 26, and thus from the first tube portion 24 to the second tube portion 34.
[0148] The diameter of the piston head 68 is less than the diameter of the implantation tube 36, so that the piston head moves in translation inside the implantation tube 36.
[0149] The pushing device 60 is actuated so as to push the vertebral spacer element 100 in the compressed state to the distal end 20b of the guiding device 20, in order to extract it from the guiding device 20, as illustrated in FIG. 12. The vertebral spacer element is pushed through the distal opening 29 out of the guiding device. The distal end of the guiding device 20 is positioned so as to guide the vertebral spacer element 100 to between two successive vertebrae, where it deploys and is held in position in particular by the wings 102, 104, as illustrated in FIG. 13.
Claims
Claims 1. A vertebral implantation system (10) for a vertebral spacer element (100) at least partially elastically deformable between a deployed state and a compressed state, the implantation system comprising: a compression device (40) having a housing (46) for receiving the vertebral spacer element in the deployed state, the compression device being configured to exert a compressive force on said vertebral spacer element located in said housing so as to cause said vertebral spacer element to pass from the deployed state to the compressed state; a guide device (20) having an open distal end (20b) and comprising an implantation tube (36), the guide device being connectable to said compression device;and a pushing device (60) configured to cooperate: with the compression device, when the guide device is connected thereto, to push the vertebral spacer element in the compressed state from the housing of the compression device to the interior of the implantation tube of the guide device; and with the guide device to push the vertebral spacer element in the compressed state along the implantation tube to the distal end of the guide device, so as to extract said vertebral spacer element from the guide device.; 2. Implantation system according to claim 1, wherein the guide device (20) has a proximal end (20a), opposite said distal end (20b), configured to be connected to the compression device (40) or to the pushing device (60).
3. Implantation system according to claim 2, wherein the guide device (20) comprises a first connector portion (23), wherein the compression device (40) comprises a second connector portion (58) configured to cooperate with the first connector portion for connecting the guide device to the compression device, and wherein the pushing device (60) comprises a third connector portion (69) configured to cooperate with the first connector portion for connecting the guide device to the pushing device.
4. Implantation system according to claim 3, wherein the first connector portion (23) and at least one of said second and third connector portions (58,69) comprise complementary bayonet connection portions.
5. Implantation system according to any one of claims 1 to 4, wherein said guide device (20) comprises: a transfer cartridge (22) comprising a first tube portion (24) and being configured to be connected to the compression device (40); and a guide tubing (26) configured to be connected to said transfer cartridge and comprising a second tube portion (34), said first and second tube portions defining said implantation tube (36), the pushing device (60) being configured to cooperate: with the compression device, when the transfer cartridge is connected thereto, to push the vertebral spacer element (100) in the compressed state from the housing (46) of the compression device into the first tube portion of the transfer cartridge;and with said transfer cartridge, when the guide tubing is connected thereto, for pushing the vertebral spacer element in the compressed state from inside the first tube portion to the distal end (20b) of the guide device (20) via inside the second tube portion, so as to extract said vertebral spacer element from the guide device.; 6. Implantation system according to claim 5, wherein said transfer cartridge (22) has a length (I) less than half the length (L) of the guide tubing (26).
7. Implantation system according to claim 5 or 6, wherein said guide tubing (26) is configured to be connected to said transfer cartridge (22) via a bayonet connection or via a clamping ring configured to cooperate with a collar.
8. An implantation system according to any one of claims 5 to 7, wherein said guide tubing (26) comprises a tubular gripping portion (30) and a tubular body (32) connected to said tubular gripping portion, said tubular gripping portion having an outside diameter greater than an outside diameter of the tubular body.
9. Implantation system according to any one of claims 1 to 8, wherein the compression device (40) comprises a lower jaw (42), an upper jaw (44) and a clamping member (52) configured to move said upper and lower jaws towards or away from each other.
10. Implantation system according to any one of claims 1 to 9, wherein the housing (46) of the compression device (40) is cylindrical in shape.
11. Implantation system according to claims 9 and 10, wherein a first semi-cylindrical groove (43) is formed in the lower jaw (42), wherein a second semi-cylindrical groove (45) is formed in the upper jaw (44), said first and second semi-cylindrical grooves together defining said housing (46) of said compression device (40).
12. Implantation system according to any one of claims 1 to 11, wherein the pushing device (60) comprises a main body (62), a piston (66) and a trigger (70) configured to cause the translational movement of the piston relative to the main body when it is actuated.
13. Implantation system according to claim 12, wherein the piston (66) comprises a rod (67) and a piston head (68), said piston head having a diameter smaller than the diameter of the implantation tube (36) of the guide device (20).
14. Implantation system according to any one of claims 1 to 13, wherein the distal end (20b) of the guide device (20) is at least partially beveled.
15. An implantation system according to any one of claims 1 to 14, wherein the distal end (20b) of the guide device (20) comprises a domed engagement portion (28).