BE1024405B1 - CANUSED BONE SCREW AND METHODS OF USE - Google Patents

Abstract

The present invention relates to a bone screw (1) comprising a screw body (11) having a proximal end, a distal end, a longitudinal axis and a thread (111) along all or a portion of said screw body ; a screw head (12); a through bore extending coaxially through said screw head (12) and through said screw body (11) from the proximal end to the distal end; at least three angular blind channels disposed around the bore; each of said channels being configured to receive a catheter (21) or a needle; a plurality of radially arranged fenestrations (112); each of said channels being connected to an outside of said screw body through at least one fenestration (21); and flexible steering means (15) attached to the screw head (12). The present invention also relates to a system (2) comprising such a bone screw.

Description

(30) Priority data:

(73) Holder (s):

CM DEVELOPPEMENT Limited Liability Company with single partner

92350, LE PLESSIS ROBINSON

France (72) Inventor (s):

MAZEL Christian

92350 LE PLESSIS ROBINSON

France (54) CANNULATED BONE SCREW AND METHODS OF USE (57) The present invention relates to a bone screw (1) comprising a screw body (11) comprising a proximal end, a distal end, a longitudinal axis and a thread (111 ) along all or part of said screw body; a screw head (12); a through bore extending coaxially through said screw head (12) and through said screw body (11) from the proximal end to the distal end; at least three blind channels angularly arranged around the bore; each of said channels being configured to receive a catheter (21) or a needle; a plurality of windows (112) arranged radially; each of said channels being connected to an exterior of said screw body through at least one fenestration (21); and flexible steering means (15) attached to the screw head (12). The current

FlG.l the invention also relates to a system (2) comprising such a bone screw.

BELGIAN INVENTION PATENT

FPS Economy, SMEs, Middle Classes & Energy

Publication number: 1024405 Deposit number: BE2016 / 0127

Intellectual Property Office

International Classification: A61B 17/86 A61B 17/88 Date of issue: 02/14/2018

The Minister of the Economy,

Having regard to the Paris Convention of March 20, 1883 for the Protection of Industrial Property;

Considering the law of March 28, 1984 on patents for invention, article 22, for patent applications introduced before September 22, 2014;

Given Title 1 “Patents for invention” of Book XI of the Code of Economic Law, article XI.24, for patent applications introduced from September 22, 2014;

Having regard to the Royal Decree of 2 December 1986 relating to the request, the issue and the maintenance in force of invention patents, article 28;

Given the patent application received by the Intellectual Property Office on 07/14/2016.

Whereas for patent applications falling within the scope of Title 1, Book XI of the Code of Economic Law (hereinafter CDE), in accordance with article XI. 19, §4, paragraph 2, of the CDE, if the patent application has been the subject of a search report mentioning a lack of unity of invention within the meaning of the §ler of article XI.19 cited above and in the event that the applicant does not limit or file a divisional application in accordance with the results of the search report, the granted patent will be limited to the claims for which the search report has been drawn up.

Stopped :

First article. - It is issued to

CM DEVELOPPEMENT Limited liability company with sole partner, 22 Grande Rue, 92350 LE PLESSIS ROBINSON France;

represented by

ICOSA EUROPE, Brussels Life Sciences Incubator Clos Chapelle aux Champs 30 box 1.30.30, 1200, BRUXELLES;

a 20-year Belgian invention patent, subject to payment of the annual fees referred to in article XI.48, §1 of the Code of Economic Law, for: CANNULATED BONE SCREW AND METHODS OF USE.

INVENTOR (S):

MAZEL Christian, 22 Grande Rue, 92350, LE PLESSIS ROBINSON;

PRIORITY (S):

DIVISION:

divided from the basic application: filing date of the basic application:

Article 2. - This patent is granted without prior examination of the patentability of the invention, without guarantee of the merit of the invention or of the accuracy of the description thereof and at the risk and peril of the applicant (s) ( s).

Brussels, 02/14/2018, By special delegation:

BE2016 / 0127

CANNULATED BONE SCREW AND METHODS OF USE

FIELD OF THE INVENTION

The present invention relates to the field of bone screws. In particular, the invention relates to cannulated bone screws and to methods of using them for bone treatment.

STATE OF THE ART

The delivery of drugs or treatments to the bone is often a beneficial process but difficult to perform, especially if one wishes to concentrate the delivery within a bone or to a particular area in a bone.

US 2014/0236242 teaches to use a screw for fixing bone comprising an elongated rod defining a longitudinal internal passage and at least one rod opening in communication with the longitudinal internal passage. However, with such a device, the release of substances into the bone is mainly distal due to the distal opening necessary to insert a guide wire. Such a guidewire is necessary for minimally invasive surgery. Minimally invasive surgery, which is applied to an increasing number of cases, indeed requires guide wires to position an implant in the implantation site.

EP 2,570,093 suggests inserting a plug element into the longitudinal internal passage to close the passage at the distal end after the guide wire has been removed. Such a system allows the radial ejection of the substance by preventing the distal discharge of the fluid. However, the insertion of the plug element requires complex handling.

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A first object of the invention is therefore to provide a bone screw allowing the release of substances in an oriented manner, while allowing miniinvasive surgery.

The object is achieved by the device as defined in the claims. The present invention relates in particular to a bone screw having a longitudinal axis, a through bore extending coaxially and at least three blind channels angularly arranged around the through bore. Each blind channel is connected to the outside of the bone screw by fenestrations. With such a device, the release of substances can be oriented by selecting the desired blind channel.

Directing the distribution of a substance inside the bone can be important, especially for treating the intervertebral disc. The intervertebral disc does not have any specific vascularization. Nutrients in avascular tissue are delivered by diffusion from capillaries at the disc-vertebral body interface. Therefore, intravenous treatments have difficulty accessing the intervertebral disc. The state-of-the-art procedure requires drilling the disc and perforating the disc ring. However, such a procedure often leads to degenerative disc disease.

Consequently, a second object of the invention is to allow the treatment of the intervertebral disc without perforation of the ring of the disc.

The cannulated bone screw according to the invention has the advantage that it can release a substance inside the vertebral body precisely towards the upper plate or the lower plate; such substances then being diffused respectively into the upper or lower intervertebral disc.

Alternatively, the cannulated bone screw according to the invention can also be used with radioactive needles positioned in the blind canals, thus providing local radiotherapy within the bone.

After insertion of the implant into the vertebral body, a catheter, inserted into a blind canal, can be connected to a pump implanted just below the surface of the skin. The

BE2016 / 0127 patient can thus keep the system for several hours to several days. Once the treatment is finished, in order to access the bone screw percutaneously, it is necessary that the extraction means locate the screw head easily.

A third object of the invention is therefore to provide a bone screw allowing removal by minimally invasive surgery.

The object is achieved by the device as defined in the claims. In particular, the present invention provides flexible steering means fixed to the screw head so that the extraction means can be guided towards the screw head. Since the steering means are fixed to the screw head, the extraction means can slide around said steering means until they come into abutment against the screw head for recovery.

ABSTRACT

The present invention relates to a bone screw comprising:

- a screw body comprising a proximal end, a distal end, a longitudinal axis and a thread along all or part of said screw body;

- a screw head fixed to the proximal end of the screw body;

- a through bore extending coaxially through said screw head and through said screw body from the proximal end to the distal end;

- at least three blind channels angularly arranged around the through bore; said channels extending longitudinally through said screw head and through part of said screw body; and each of said blind channels being configured to receive a catheter or needle;

- a plurality of radially arranged windows; each of said blind channels being connected to an external part of said screw body by means of at least one fenestration; and

- a flexible steering means fixed to the screw head so that an extraction means can be guided towards its screw head along said steering means.

In one embodiment, the at least three blind channels are regularly angularly arranged. In one embodiment, the bone screw includes four

BE2016 / 0127 blind channels arranged every 90 °. In one embodiment, at least one of the blind channels has a length different from that of the other channels.

In one embodiment, the fenestrations are elongated holes. In one embodiment, a fenestration is located at the distal end of each blind channel.

In one embodiment, the at least one fenestration connecting each blind channel to the outside of the screw body are not positioned in the same transverse plane. In one embodiment, the windows are positioned between the crests of the thread.

In one embodiment, the bone screw further comprises an opaque (or radio-opacifying) radio10 marker allowing the positioning, in particular the angular positioning, of the bone screw in the bone.

In one embodiment, the flexible steering means are a wire, preferably a braided wire, preferably a braided metal wire. In one embodiment, the flexible steering means is hollow and configured to receive at least one catheter or at least one needle. According to this embodiment, the flexible steering means can be a braided sheath, preferably a braided metal sheath; or a spiral sheath, preferably an elastic or metallic spiral sheath.

In one embodiment, the thread pitch varies along the body of the screw. In one embodiment, the thread pitch is wider in the distal part of the screw body than in the proximal part of the screw body.

The present invention also relates to a system comprising a bone screw according to the present invention and at least one catheter, such as for example a perforated catheter, or at least one needle, such as for example a radioactive needle.

In one embodiment, the system further comprises a plug having an opening for each catheter or each needle and for guide means; said plug being configured to be inserted into the screw head in a sealed manner.

In one embodiment, the system further includes a subcutaneous fluid pump fluidly connected to the catheter.

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The present invention further relates to a method of delivering a substance to an intervertebral disc; said method comprises the following steps:

the implantation via a transpedicular approach of at least one system comprising:

- a bone screw comprising:

- a screw body comprising a proximal end, a distal end, a longitudinal axis and a thread along all or part of said screw body;

- a screw head fixed to the proximal end of the screw body;

- a through bore extending coaxially through said screw head and through said screw body from the proximal end to the distal end;

- at least three blind channels angularly arranged around the through bore; said channels extending longitudinally through said screw head and through part of said screw body; and each of said blind channels being configured to receive a catheter or needle;

- a plurality of radially arranged windows; each of said blind channels being connected to an external part of said screw body by means of at least one fenestration; and

- flexible steering means fixed to the screw head so that an extraction means can be guided towards the screw head; and

- at least three perforated catheters, in which each connecting channel comprises a perforated catheter, selecting the catheter which is in the blind channel directed towards the upper or lower end plate; and delivering a substance into the selected catheter so that the substance diffuses to the upper or lower intervertebral disc, respectively.

In one embodiment, the method further includes the step of implanting a fluid pump fluidly connected to the selected catheter subcutaneously.

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In one embodiment, the method further comprises the step of guiding an extraction means along the flexible direction means towards the screw head and at the extraction of the bone screw and the at least three catheters .

The present invention further relates to a method of treating vertebral tumors; said method comprises the following steps:

the implantation via a transpedicular approach of at least one system comprising:

- a bone screw comprising:

- a screw body comprising a proximal end, a distal end, a longitudinal axis and a thread along all or part of said screw body;

- a screw head fixed to the proximal end of the screw body;

- a through bore extending coaxially through said screw head and through said screw body from the proximal end to the distal end;

- at least three blind channels arranged angularly around the through bore; said channels extending longitudinally through said screw head and through part of said screw body; and each of said blind channels being configured to receive a perforated catheter or needle;

- a plurality of radially arranged windows; each of said blind channels being connected to an external part of said screw body by means of at least one fenestration; and

- flexible steering means fixed to the screw head so that extraction means can be guided towards the screw head; and

- at least one radioactive needle positioned in at least one blind channel; irradiation of the vertebra; and guiding an extraction means along the direction means towards the screw head and the extraction of the bone screw and the at least one needle.

BE2016 / 0127

DEFINITIONS

In the present invention, the terms below are defined as follows:

- The term "approximately" is used here to mean approximately, approximately, around or in the region of. When the term "approximately" is used in conjunction with a numeric range, it modifies that range by extending the limits above and below the indicated numeric values. In general, the term "about" is used here to modify a numerical value above and below the value indicated by a variance of 20 percent, preferably 5 percent.

- "Distal" refers to the direction in which the bone screw is advanced as the bone screw engages in the bone and "proximal" refers to the direction opposite to the distal direction.

- "Flexible" refers to the ability of an object to deform in a reversible manner. “Longitudinal direction” designates the extension in the direction of the length of a material.

- "Substance" refers to one or more chemical compounds which are useful when delivered near a bone, preferably near a vertebra or near an intervertebral disc. Substances can be chosen to help treat sick bones or joints. A representative example of substances includes drugs or therapeutic agents such as anti-inflammatory drugs, anesthetics, antibiotics, chemotherapeutic agents, interleukin, bone morphogenetic proteins, bone growth factors or disc nutrients. In the present invention, a substance can be a liquid or a gel.

- A “therapeutically effective quantity” designates the level or quantity of agent which aims to, without causing significant or secondary negative effects on the target, (1) delay or prevent the appearance of a disease; (2) slow or stop the progression, worsening or worsening of one or more symptoms of the disease; (3) bring about improvements in symptoms of the disease; (4) reduce the severity or incidence of the disease; or (5) cure the disease. A therapeutically effective amount may be administered before the onset of the disease, for prophylactic or preventive action. Alternatively or additionally, the quantity

BE2016 / 0127 therapeutically effective can be administered after the onset of the disease, for a therapeutic action.

- In the present invention, a "through bore" is a hole which passes through all the material. This term is to be distinguished from a "blind channel", which does not cross all the material of the object.

- "Transverse plane" refers to a plane perpendicular to the longitudinal axis of the screw body.

DETAILED DESCRIPTION

The following detailed description will be better understood when read in conjunction with the drawings. For purposes of illustration, the device is shown in the preferred embodiments. However, it should be understood that the application is not limited to the precise arrangements, structures, characteristics, embodiments and aspect illustrated. The drawings are not drawn to scale and are not intended to limit the scope of the claims to the embodiments shown. Consequently, it should be understood that, when the features mentioned in the appended claims are followed by reference signs, such signs are included for the sole purpose of increasing the intelligibility of the claims and are in no way limitative of the scope demands.

Figs. 1 to 9 show a bone screw or a system comprising the bone screw according to the invention. As shown in Fig. 2, the bone screw 1 comprises a screw body 11 for anchoring in the bone, for example, a vertebra 3. The body of said screw 11 comprises a proximal end, a distal end which can be configured as a point, a longitudinal axis and a thread 111 along all or part of said screw body 11. Said thread 111 is located along all or part of the outside of the screw body 11. The bone screw 1 comprises furthermore a screw head 12 fixed to the proximal end of the screw body 11. The screw head 12 can be any screw head comprising an engagement structure, for example a hexagonal screw head, as shown in Fig. 1, for engagement with a tool, for example insertion means and extraction means. In a mode of

BE2016 / 0127 embodiment, the screw head 12 is integral with the screw body. In one embodiment, the screw body 11 has a length which varies from 35 to 55mm. In one embodiment, as shown in FIG. 2, the screw body 11 is substantially cylindrical and the diameter of the screw body 11 varies from 5.5mm to 6.5mm, preferably around 6mm.

The material from which the bone screw 1, in particular the screw body 11 and the screw head 12 is made, can be any material which is usual for bone screws. In one embodiment, said material is titanium, a titanium alloy such as nitinol, stainless steel or any biocompatible metal alloy. In another embodiment, said material is a biocompatible plastic material, such as

PEEK.

According to one embodiment, the thread pitch 111 varies along the body of the screw 1L

According to one embodiment, the pitch of the thread 111 is wider in the distal part of the screw body 11 than in the proximal part of the screw body 11. Said embodiment can improve the anchoring of the bone screw to the inside the pedicle of a vertebra.

The bone screw 1 is cannulated. As shown in figs. 2, 3A and 3B, it has a through bore 13 extending coaxially through said screw head 12 and through said screw body 11 from the proximal end to the distal end. The diameter of the bore 13, and in particular of the portion of the bore extending inside the screw body 11, is designed so that the guide means 22 (see FIG. 7B), commonly used for minimally invasive surgery, can be guided through the bone screw 1. In one embodiment, the diameter of the bore 13 varies from 0.8mm to 2.8mm, preferably about 1.8mm.

As shown in Figs. 2, 3A, 3B and 9, the bone screw 1 further comprises at least three blind channels 14 angularly (that is to say peripherally) arranged (or positioned) around the through bore 13. Said blind channels 14 s extend longitudinally (that is to say parallel to the longitudinal axis of the screw body 11) through said screw head 12 and through a part of said screw body 11. According to one embodiment, said blind channels 14 are regularly arranged around

BE2016 / 0127 the through bore 13. According to one embodiment, as shown in FIG. 3A, the bone screw 1 comprises three blind channels 14, preferably three blind channels equally spaced around the through bore 13, namely every 120 °. According to one embodiment, as shown in FIG. 3B, the bone screw 1 comprises four blind channels 14, preferably four blind channels also spaced around the through bore 13, namely every 90 °. As is obvious to a person skilled in the art, the bone screw can have as many blind channels as required for a person skilled in the art, for example 3,4, 5, 6, 7 or 8 blind channels. The blind channels 14 are not fluidly connected to the through bore 13 in the screw body

11.

In one embodiment, each blind channel 14 has the same diameter. The diameter of the blind channels 14 and in particular of the part of the blind channel 14 extending inside the screw body 11, is designed so that a catheter or needle can be guided through it. In one embodiment, the diameter of the blind channels

14 varies from 0.5mm to 2.5mm, preferably around 1.5mm. In one embodiment, each of said blind channels 14 is configured to at least partially receive a catheter or needle.

According to one embodiment, at least one of the blind channels 14 has a length different from that of the other channels. This embodiment guarantees that the substances are delivered to a particular location along the body of the screw 11 as a function of the blind channel 14. According to one embodiment, each of the blind channels 14 has a different length.

As shown in fig. 1, 2, 4, 5 and 6, the bone screw also has a plurality of fenestrations 112 arranged radially. Fenestration 112 connects a blind channel 14 outside said screw body 11. In one embodiment, the bone screw 1 comprises as many fenestrations 112 as there are blind channels 14. In another embodiment, the bone screw 1 comprises more than one fenestration 1 to 2 for each blind channel 14. In one embodiment, the fenestrations 112 are arranged radially of the blind channels 14 towards the outside of the screw body 11.

he

BE2016 / 0127

According to one embodiment, the windows 112 are circular. According to a preferred embodiment, the windows 112 are elongated holes. Such an embodiment maximizes the surface of the hole and prevents clogging due to scarring, once the bone screw is inserted into the bone.

According to one embodiment, the elongated holes have an elliptical shape. In one embodiment, the minor axis of the elliptical hole is perpendicular to the longitudinal axis of the bone screw and has a length less than a quarter of the perimeter of the screw body 11 measured in a transverse plane. Such an embodiment prevents a fenestration 112 overlapping two blind channels. In one embodiment, the minor axis has a length equal to one-fifth, one-sixth, one-seventh, or one-eighth of the perimeter of the screw body 11. In one embodiment, the major axis of the elliptical hole is parallel to the longitudinal axis of the bone screw 1 and its length is equal to at least two or at least three times the length of the minor axis.

According to one embodiment, a fenestration 112 is located at the distal end of each blind channel 14.

According to an embodiment in which the bone screw 1 is intended to be inserted into a vertebra 3, the fenestrations 112 are located on the distal part of the body of the screw 11 so that the substances can be delivered into the vertebral body and not in the pedicle. According to one embodiment, the fenestrations 112 are not located on the proximal part of the screw body 11. In one embodiment, the length of the proximal part of the screw body 11 is approximately 15mm.

According to one embodiment, the fenestrations 112 connecting each blind channel 14 to an exterior of the screw body 11 are not positioned in the same transverse plane. According to one embodiment, the windows 112 connecting adjacent blind channels 14 to an exterior of the screw body 11 are not positioned in the same transverse plane. Said embodiments guarantee that the substances are delivered to a particular location along the length of the screw body 11 depending on the blind channel 14. Said embodiments also reinforce the mechanical design of the bone screw 1.

BE2016 / 0127

According to one embodiment, as shown in FIG. 1, the windows 112 are positioned between the crests of the thread.

The bone screw further comprises flexible steering means 15 fixed to the screw head 12 so that extraction means can be guided towards the screw head

12. In one embodiment, as shown in FIG. 7A, the flexible steering means 15 are fixed to a proximal end of the screw head 12. The flexible steering means 15 can be fixed to the screw head 12 by any means known to those skilled in the art such as for example bonding, welding or screwing. According to one embodiment, the flexible steering means 15 have a length varying from 10 to 15 cm, preferably about 12 cm.

According to one embodiment, as shown in FIG. 4, the flexible steering means 15 is a flexible wire 153, preferably a flexible braided wire, preferably a flexible braided metal wire.

According to alternative embodiments, the steering means 15 are hollow and configured to receive at least partially at least one catheter or at least one needle, as shown in FIGS. 5 and 6. According to one embodiment, as shown in FIG. 7B, the hollow flexible steering means 15 is configured to receive the guide means 22 and as many catheters or needles as there are number of blind channels 14. According to one embodiment, the flexible steering means

15 hollow are a sheath, preferably a cylindrical sheath. According to one embodiment, as shown in FIG. 5, the hollow flexible steering means 15 comprises a braided sheath 151, preferably a braided metallic sheath. According to another embodiment, as shown in FIG. 6, the hollow flexible steering means 15 comprises a spiral sheath 152, preferably an elastic or metallic spiral sheath.

According to one embodiment, the bone screw 1 further comprises a radio-opaque marker (not shown) allowing the positioning, in particular the angular positioning, of the bone screw in the bone. Said embodiment allows the surgeon to choose the blind channel for delivering a substance in the chosen direction.

BE2016 / 0127

The present invention also relates to a system 2 comprising a bone screw 1 according to the present invention.

As shown in Fig. 1, the system 2 comprises a bone screw 1, comprising:

a screw body 11 comprising a proximal end, a distal end, a longitudinal axis and a thread 111 along all or part of said screw body;

a screw head 12 fixed to the proximal end of the screw body 11;

a through bore extending coaxially through said screw head 12 and through said screw body 11 from the proximal end to the distal end;

at least three blind channels angularly arranged around the through bore; said channels extending longitudinally through said screw head 12 and through a part of said screw body 11; and each of said blind channels being configured to receive a catheter 21 or a needle;

a plurality of radially arranged windows 112; each of said blind channels being connected to an exterior of said screw body 11 through at least one window 112; and flexible steering means 15 fixed to the screw head 12 so that extraction means can be guided towards the screw head along said means; and at least one catheter 21, preferably a perforated catheter.

The system 2 comprises a bone screw 1 and at least one catheter 21, such as a perforated catheter 21, or at least one needle, such as a radioactive needle. In one embodiment, the catheter 21 is perforated on its distal portion so that when the catheter 21 abuts against the distal end of a blind channel 14, the substances are delivered only into the body of the screw 11. In one embodiment, the system 2 has only one catheter 21 or needle. In one embodiment, the system 2 only comprises two catheters 21 or needles. In another embodiment, the system 2 comprises a needle or a catheter 21 in each blind channel 14,

BE2016 / 0127

According to one embodiment, the system 2 further comprises guide means

22.

According to one embodiment, the system 2 further comprises a plug 23. Said plug 23 is configured to be inserted in the screw head 12 in a sealed manner.

In one embodiment, the plug 23 has on its periphery an O-ring 231 ensuring the seal between the plug 23 and the screw head 12.

According to one embodiment, the plug 23 has an opening for each catheter 21 or each needle. Said openings are dimensioned so as to seal between the opening and the catheter 21 or the needle. Said openings optionally include an O-ring.

According to one embodiment, the plug 23 has an opening for the guide means 22. Said opening is dimensioned so as to seal between the guide means 22 and the plug 23. In one embodiment, said opening comprises an O-ring. In another embodiment, as shown in FIG. 8, the plug 23 comprises a guide tube 232 connected to the plug 23 in a sealed manner. Said guide tube 232 is configured to receive the guide means 22 in a sealed manner. In one embodiment, said guide tube 232 comprises an O-ring 2321 for sealing between the guide means 22 and the guide tube 232.

The plug 23 according to the present invention prevents the flow back from the blind channels 14 and the exchange of substances between the blind channels 14 through the screw head 12.

According to one embodiment, the system 2 further comprises a subcutaneous fluid pump fluidly connected with the at least one catheter 21. In one embodiment, the fluid pump can be fluidly connected to each catheter

21.

According to one embodiment, the system 2 also comprises at least one substance.

BE2016 / 0127

The present invention further relates to a method for delivering at least one substance into a vertebral body. Said method comprises the following steps:

- The placement of a guide means 22, such as a guide wire, percutaneously through the skin to the final position of the bone screw in a vertebra 3;

- Guiding the system 2, comprising the bone screw 1 and at least three catheters 21 perforated along the guide means 22 on the vertebra 3 and the screwing of the bone screw;

- removal of the guide means 22;

- the selection of at least one catheter 21 which is in a blind channel 14 of interest;

the delivery of at least one substance into the catheter 21 chosen so that the at least one substance is delivered inside the vertebral body in a chosen direction;

optionally, the implantation of a fluid pump in fluid connection with the selected catheter subcutaneously.

In one embodiment, its method comprises guiding extraction means along flexible steering means 15 at the screw head 12 and extracting the bone screw 1 and the at least three catheters 21.

The present invention further relates to a method of treating a disease, comprising delivering a therapeutically effective amount of at least one substance into a vertebral body. Said method comprises the following steps:

- The placement of the guide means 22, such as a guide wire, percutaneously through the skin to the final position of the bone screw in a vertebra 3;

guiding the system 2, comprising the bone screw 1 and at least three catheters 21 perforated along the guide means 22 up to the vertebra 3 and screwing the bone screw;

- ie removal of the guide means 22;

- the selection of at least one catheter 21 which is in a blind channel 14 of interest;

BE2016 / 0127

- the delivery of the therapeutically effective amount of at least one substance into the catheter 21 chosen so that the at least one substance is delivered to the interior of the vertebral body in a chosen orientation;

- optionally, the implantation of a fluid pump in fluid connection with the 5 catheter selected subcutaneously.

In one embodiment, the method comprises guiding the extraction means along flexible direction means 15 up to the screw head 12 and {extraction of the bone screw 1 and the at least three catheters 21.

In one embodiment, the disease is selected from metastasis of the vertebral body, vertebral tumor, acute lumbar pain, spondylodiscitis of the intervertebral disc or degenerative disc disease.

The present invention further relates to a method of delivering at least one substance to an intervertebral disc. Said method comprises the following steps:

- The placement of the guide means 22, such as a guide wire, percutaneously 15 through the skin to the final position of the bone screw in a vertebra 3;

- removal of the system 2, comprising the bone screw 1 and at least three catheters 21 perforated along the guide means 22 to the vertebra 3 and the screwing of the bone screw;

- removal of the guide means 22;

the selection of the catheter 21 which is in the blind channel 14 directed towards the upper or lower end plate;

- the delivery of at least one substance into the catheter 21 chosen so that the at least one substance is diffused towards the upper or lower intervertebral disc respectively;

- optionally, the implantation of a fluid pump in fluid connection with the selected catheter subcutaneously.

In one embodiment, the method comprises guiding the extraction means along flexible direction means 15 up to the screw head 12 and the extraction of the bone screw 1 and the at least three catheters 21.

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The present invention further relates to a method of treating a disease, comprising delivering a therapeutically effective amount of at least one substance to an intervertebral disc. Said method comprises the following steps: placing the guide means 22, such as a guide wire, percutaneously through the skin until the final position of the bone screw in a vertebra 3;

the removal of the system 2, comprising the bone screw 1 and at least three catheters 21 perforated along the guide means 22 up to the vertebra 3 and the screwing of the bone screw;

- removal of the guide means 22;

the selection of the catheter 21 which is in the blind channel 14 directed towards the upper or lower end plate;

- the delivery of a therapeutically effective amount of at least one substance into the catheter 21 chosen so that the therapeutically effective amount of the at least one substance is diffused towards the upper or lower intervertebral disc respectively;

- optionally, the implantation of a fluid pump in fluid connection with the selected catheter subcutaneously.

In one embodiment, the method comprises guiding the extraction means along flexible direction means 15 at the screw head 12 and extracting the bone screw 1 and the at least three catheters 21.

In one embodiment, the disease is selected from metastasis of the vertebral body, vertebral tumor, acute lumbar pain, spondylodiscitis of the intervertebral disc or degenerative disc disease.

In one embodiment, the bone screw is implanted via a transpedicular approach.

In one embodiment, the system comprises a catheter 21 perforated in each blind channel 14.

In one embodiment, the system comprises a plug 23.

BE2016 / 0127

According to one embodiment, the substances delivered are chemotherapeutics for the treatment of metastases of the vertebral body or of vertebral tumor. According to another embodiment, the substances delivered are anesthetics for treating acute lumbar pain. According to one embodiment, the substances delivered are antibiotics for treating spondylodiscitis of the intervertebral disc. According to one embodiment, the substances delivered are nutrients for ensuring intervertebral regeneration. According to one embodiment, the substances delivered are growth factors, non-steroid drugs, steroids, anti TNFα to treat degenerative disc disease. According to one embodiment, the substances delivered are anesthetics for treating acute lumbar pain.

The present invention further relates to a method of treating a vertebra; said method comprising the steps consisting:

- The placement of the guide means 22, such as a guide wire, percutaneously through the skin to the final position of the bone screw in a vertebra 3;

- guiding the system 2, comprising the bone screw 1 and at least one radioactive needle along the guide means 22 to the vertebra 3 and the screwing of the bone screw;

upon removal of the guide means 22;

- the irradiation of the vertebra 3; and

- guiding the extraction means along the flexible steering means 15 to the screw head 12 and extract the bone screw 1 and the at least one needle.

In one embodiment, said method is useful for treating metastasis of the vertebral body or a vertebral tumor.

In one embodiment, the system comprises a radioactive needle in each blind channel 14.

In one embodiment, the system comprises a plug 23.

Although various embodiments have been described and illustrated, the detailed description should not be considered as being limited to the present. Various modifications

BE2016 / 0127 can be brought to the embodiments by those of the trade without departing from the true spirit and the scope of the invention as defined by the claims.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 shows the system comprising two catheters according to the invention.

Figure 2 is a sectional view of a bone screw according to the present invention in a vertebra.

Figure 3A is a sectional view of the screw body in a transverse plane in which the bone screw comprises three blind channels.

Figure 3B is a sectional view of the screw body in a transverse plane in which the bone screw comprises four blind channels.

Figure 4 is a partial side view of the bone screw according to the present invention, in which the flexible steering means is a braided wire.

Figure 5 is a partial side view of the bone screw according to the present invention, in which the flexible steering means is a braided sheath.

Figure 6 is a partial side view of the bone screw according to the present invention, in which the flexible steering means is a spiral sheath.

Figure 7 A is a partial front view of the bone screw according to the present invention.

Figure 7B is a partial front view of the system comprising four catheters and guide means according to the present invention.

Figure 8 illustrates the plug according to the present invention.

Figure 9 is a sectional view of a system comprising at least two catheters according to the present invention in a vertebra.

BE2016 / 0127

REFERENCES

- Bone screw;

- Screw body;

111 - Threading;

112 - Windows;

- Screw head ;

- Through bore;

- Blind channel;

- Means of management;

151 ”Braided sleeving;

152 - Spiral sheath; 153-Wire;

- System;

- Catheter;

22 - Guide means;

”Stopper;

231 - O-ring;

232 - Guide tube; 2321 - O-ring;

3 - Vertebra.

BE2016 / 0127

Claims (8)

1. A bone screw (1), comprising: - a screw body (11) comprising a proximal end, a distal end, a longitudinal axis and a thread (111) along all or part 5 of said screw body; - a screw head (12) fixed to the proximal end of the screw body (11); - a through bore (13) extending coaxially through said screw head (12) and through said screw body (11) from the proximal end to the distal end; 10 - at least three blind channels (14) angularly arranged around the through bore (13); said channels extending longitudinally through said screw head (12) and through a portion of said screw body (11); and each of said blind channels (14) being configured to receive a catheter or needle; - a plurality of windows (112) arranged radially; each of said 15 blind channels (14) being connected to an exterior of said screw body (11) through at least one fenestration (112); and - flexible steering means (15) fixed to the screw head (12) so that the extraction means can be guided up to the screw head along said means. 20 2. The bone screw (1) according to claim 1, wherein the fenestrations (112) are elongated holes. 3. The bone screw (1) according to any one of claims 1 to 2, in which the fenestrations (112) are arranged between the crests of the thread. 4. The bone screw (1) according to any one of claims 1 to 3, in which At least one of the blind channels (14) has a length different from that of the other channels. 5. The bone screw (1) according to any one of claims 1 to 4, in which a fenestration (112) is located at the distal end of each blind channel (14). BE2016 / 0127 6. 7. 8, 10 9. 10. The bone screw (1) according to any one of claims 1 to 5, in which the at least one fenestration (112) connecting each blind channel to an exterior of the screw body are not positioned in the same transverse plane. The bone screw (1) according to any one of claims 1 to 6, further comprising a radiopaque marker allowing the positioning, in particular the angular positioning, of the bone screw in the bone. The bone screw (1) according to any one of claims 1 to 7, in which the flexible steering means (15) comprises a wire (153), preferably a braided wire, preferably a braided metal wire, The bone screw (1) according to any of claims 1 to 7, wherein the flexible steering means (15) is a hollow braided sheath (151) or a hollow spiral sheath (152) configured to receive at least one catheter (21) or at least one needle. A system (2) comprising a bone screw (1) according to any one of claims 1 to 9; at least one catheter (21), such as a perforated catheter, or at least one needle, such as a radioactive needle; and a stopper having an opening for each catheter or for each needle; wherein said plug is configured to be inserted into the screw head (12) in a sealed manner. BE2016 / 0127 * ÏG .; BE2016 / 0127